[Federal Register Volume 89, Number 128 (Wednesday, July 3, 2024)]
[Proposed Rules]
[Pages 55312-55425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14254]



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Vol. 89

Wednesday,

No. 128

July 3, 2024

Part II





Department of Health and Human Services





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Centers for Medicare and 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; Proposed Rule

  Federal Register / Vol. 89 , No. 128 / Wednesday, July 3, 2024 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 424, 483, and 484

[CMS-1803-P]
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: Proposed rule.

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SUMMARY: This proposed rule would 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 proposes 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 proposes a new standard for 
acceptance to service policy in the HH conditions of participation 
(CoPs) and includes requests for information (RFIs) soliciting input on 
permitting rehabilitative therapists to conduct the initial and 
comprehensive assessment and the factors that may influence the patient 
referral and intake processes. Lastly, it proposes updates to provider 
and supplier enrollment requirements and changes to the long-term care 
reporting requirements for acute respiratory illnesses.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided in the ADDRESSES section, no later than 5 p.m. 
EDT on August 26, 2024.

ADDRESSES: In commenting, please refer to file code CMS-1803-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission. Comments, including mass comment 
submissions, must be submitted in one of the following three ways 
(please choose only one of the ways listed):
    1. Electronically. You may (and we encourage you to) submit 
electronic comments on this regulation to https://www.regulations.gov. 
Follow the instructions under the ``submit a comment'' tab.
    2. By regular mail. You may mail written comments to the following 
address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-1803-P, P.O. Box 8013, Baltimore, MD 
21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments via 
express or overnight mail to the following address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-1803-P, Mail Stop C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, we refer readers to the 
beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Brian Slater, (410) 786-5229, for home 
health and home IVIG payment inquiries.
    For general information about the Home Health Prospective Payment 
System (HH PPS), send your inquiry via email to 
[email protected].
    For information about the Home Health Quality Reporting Program (HH 
QRP), send your inquiry via email to [email protected].
    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 ([email protected]), for more information about the 
long-term care requirements for participation.

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

Table of Contents

I. Executive Summary
    A. Purpose and Legal Authority
    B. Summary of the Provisions of This Proposed Rule
    C. Summary of Costs, Transfers, and Benefits
II. Home Health Prospective Payment System
    A. Overview of the Home Health Prospective Payment System
    B. Monitoring the Effects of the Implementation of PDGM
    C. Proposed CY 2025 Payment Adjustments Under the HH PPS
    D. Proposed 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 Proposed 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

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VI. Home Health CoP Changes and Long Term (LTC) Requirements for 
Acute Respiratory Illness Reporting
    A. Home Health CoP Changes
    B. Long-term Care (LTC) Requirements for Acute Respiratory 
Illness Reporting
VII. Provider Enrollment--Provisional Period of Enhanced Oversight
    A. Background
    B. Proposed Provisions--Provisional Period of Enhanced Oversight 
(PPEO)
VIII. Collection of Information Requirements
    A. Statutory Requirement for 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
X. Response to Comments

I. Executive Summary

A. Purpose and Legal Authority

1. Home Health Prospective Payment System (HH PPS)
    As required under section 1895(b) of the Social Security Act (the 
Act), this proposed rule would update the CY 2025 payment rates for 
home health agencies (HHAs) and the CY 2025 payment rate for the 
disposable negative pressure wound therapy (dNPWT) device. In this 
proposed rule, we include analysis on home health utilization, as well 
as analysis determining the difference between assumed versus actual 
behavior change on estimated aggregate expenditures for home health 
payments as result of the change in the unit of payment to 30 days and 
the implementation of the Patient Driven Groupings Model (PDGM) case-
mix adjustment methodology. This rule proposes 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 proposes a permanent prospective 
behavior adjustment to the CY 2025 home health payment rate. In 
addition, this rule proposes to recalibrate the PDGM case-mix weights 
and to update the low-utilization payment adjustment (LUPA) thresholds, 
functional impairment levels, and comorbidity adjustment subgroups 
under section 1895(b)(4)(A)(i) and (b)(4)(B) of the Act for 30-day 
periods of care in CY 2025; proposes to adopt the most recent Office of 
Management and Budget (OMB) Core-Based Statistical Area (CBSA) 
delineations for the home health wage index; and proposes an 
occupational therapy (OT) LUPA add-on factor and updates to the 
physical therapy (PT), speech-language pathology (SLP), and skilled 
nursing (SN) LUPA add-on factors. Additionally, this rule proposes to 
update 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).
2. Home Health (HH) Quality Reporting Program (QRP)
    In accordance with the statutory authority at section 
1895(b)(3)(B)(v) of the Act, we are proposing updated policies. We are 
proposing to add four new assessment items and to modify one assessment 
item on the OASIS, an update to the removal of the suspension of OASIS 
all-payer data collection, and we are seeking information on future HH 
QRP quality measure (QM) concepts.
3. 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) including a request for 
information (RFI) related to future performance measure concepts.
4. Home Intravenous Immune Globulin (IVIG) Items and Services
    In section V.D.1. of this proposed rule, we propose a rate update 
for the CY 2025 IVIG items and services payment under the home 
intravenous immune globulin (IVIG) benefit.
5. Home Health CoP Changes
    In section VI. A. of this proposed rule, we are proposing 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 propose that HHAs would be 
required to make specified information about their services and service 
limitations available to the public. Section VI.B. of this proposed 
rule includes an RFI to obtain information from stakeholders on whether 
CMS should shift its longstanding policy and permit rehabilitative 
therapists to conduct the initial and comprehensive assessment for 
cases that have both therapy and nursing services ordered as part of 
the plan of care. In addition, we are seeking public comments on other 
factors that influence the patient referral and intake processes.
6. Provider and Supplier Enrollment Requirements
    In accordance with section 1866(j)(3)(A) of the Act, we are 
proposing to revise our requirements in 42 CFR 424.527(a) regarding the 
application of provisional periods of enhanced oversight (PPEO). 
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 proposing 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.
7. Long-Term Care (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 proposing streamlined weekly data reporting requirements for 
certain respiratory illnesses. We are also proposing additional, 
related data elements that could be activated in the event of a future 
acute respiratory illness public health emergency (PHE).

B. Summary of the Provisions of This Proposed Rule

1. Home Health Prospective Payment System (HH PPS)
    In section II.B.1. of this proposed rule, we provide monitoring and 
data analysis on PDGM utilization.
    In section II.C.1 of this proposed rule, we propose a permanent 
adjustment to the base payment rate under the HH PPS. Additionally, we 
propose a

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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 proposed rule, we discuss a proposal to 
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 proposed rule, we propose to update the 
home health wage index and adopt 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 includes the CY 2025 national, 
standardized 30-day period payment rate update, the updated CY 2025 
national per-visit payment amounts by the home health payment update 
percentage, and the OT LUPA add-on factor and PT, SLP, and SN add-on 
factor updates. The proposed home health payment update percentage for 
CY 2025 is 2.5 percent. Additionally, this rule proposes the CY 2025 
FDL ratio to ensure that aggregate outlier payments are projected not 
to 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 proposed rule, we propose the CY 2025 
payment rate update for dNPWT devices.
2. Home Health Quality Reporting Program (HH QRP)
    In section III. of this proposed rule, we are proposing to collect 
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 
proposed for collection are: one Living Situation item, two Food items, 
and one Utilities item. We also propose modifying the current 
Transportation item beginning with the CY 2027 HH QRP. We are also 
proposing 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.
3. Expanded Home Health Value Based Purchasing (HHVBP) Model
    In section IV. of this proposed rule, we include 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 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).
4. Home Intravenous Immune Globulin (IVIG) Items and Services
    In section V.D.1. of this proposed rule, we propose a rate update 
for CY 2025 IVIG items and services payment under the home intravenous 
immune globulin (IVIG) benefit.
5. Home Health CoP Changes
    In section VI.A. of this proposed rule, we are proposing to add a 
new standard at Sec.  484.105(d) 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 also propose 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 propose that HHAs would be 
required to make specified information available to the public that is 
reviewed at least annually. Section VI.B. of this proposed rule we 
include an RFI to obtain information from stakeholders on whether CMS 
should shift its longstanding policy and permit rehabilitative 
therapists to conduct the initial and comprehensive assessment for 
cases that have both therapy and nursing services ordered as part of 
the plan of care. Specifically, we are seeking information regarding 
the training and education of rehabilitative therapists that is 
relevant to conducting the initial and comprehensive assessments and 
any additional information on any patient health and safety benefits or 
unintended consequences of expanding the category of clinicians that 
can conduct the initial and comprehensive assessments. In addition, we 
are seeking public comments on other factors that influence the patient 
referral and intake processes.
6. 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 proposing 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.
7. 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 
propose to replace these requirements with streamlined continued data 
reporting requirements for certain respiratory illnesses. We are also 
proposing additional, related data elements that could be activated in 
the event of a future acute respiratory illness PHE.

C. Summary of Costs, Transfers, and Benefits

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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 section 1895(b) of the Act to require a 
change to the home health unit of payment to 30-day periods beginning 
January 1, 2020. Section 51001(a)(2)(A) of the BBA of 2018 added a new 
subclause (iv) under section 1895(b)(3)(A) of the Act, requiring the 
Secretary to calculate a standard prospective payment amount (or 
amounts) for 30-day units of service furnished that end during the 12-
month period beginning January 1, 2020, in a budget neutral manner, 
such that estimated aggregate expenditures under the HH PPS during CY 
2020 are equal to the estimated aggregate expenditures that otherwise 
would have been made under the HH PPS during CY 2020 in the absence of 
the change to a 30-day unit of service. Section 1895(b)(3)(A)(iv) of 
the Act requires that the calculation of the standard prospective 
payment amount (or amounts) for CY 2020 be made before the application 
of the annual update to the standard prospective payment amount as 
required by section 1895(b)(3)(B) of the Act.
    Additionally, section 1895(b)(3)(A)(iv) of the Act requires that in 
calculating the standard prospective payment amount (or amounts), the 
Secretary must make assumptions about behavior changes that could occur 
as a result of the implementation of the 30-day unit of service under 
section 1895(b)(2)(B) of the Act and case-mix adjustment factors 
established under section 1895(b)(4)(B) of the Act. Section 
1895(b)(3)(A)(iv) of the Act further requires the Secretary to provide 
a description of the behavior assumptions made in notice and comment 
rulemaking. CMS finalized these behavior assumptions in the CY 2019 HH 
PPS final rule with comment period (83 FR 56461).
    Section 51001(a)(2)(B) of the BBA of 2018 also added a new 
subparagraph (D) to section 1895(b)(3) of the Act. Section 
1895(b)(3)(D)(i) of the Act requires the Secretary annually to 
determine the impact of differences between assumed behavior changes, 
as described in section 1895(b)(3)(A)(iv) of the Act, and actual 
behavior changes on estimated

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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 
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).
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B. Monitoring the Effects of the Implementation of PDGM

1. Routine PDGM Monitoring
    CMS routinely analyzes Medicare home health benefit utilization, 
including but not limited to, overall total 30-day periods of care and 
average periods of care per HHA user; distribution of the type of 
visits in a 30-day period of care; the percentage of periods that 
receive the LUPA; estimated costs; the percentage of 30-day periods of 
care by clinical group, comorbidity adjustment, admission source, 
timing, and functional impairment level; and the proportion of 30-day 
periods of care with and without any therapy visits, nursing visits, 
and/or aide/social worker visits. For the monitoring included in this 
proposed rule, we examine simulated data for CYs 2018 and 2019 and 
actual data for CYs 2020, 2021, 2022, and 2023 for 30-day periods of 
care. For CYs 2018 and 2019, because the HH PPS accounted for care in 
60-dayepisodes, before the transition to 30-day periods of care 
beginning in 2020, this actual data was simulated to reflect 30-day 
periods of care. We refer readers to the CY 2022 HH PPS final rule (86 
FR 35881) for further discussion about simulated data for CYs 2018 and 
2019. In this proposed rule, we are also including 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.
a. Utilization
    Table 2 shows the overall utilization of home health. The data 
indicate the average number of 30-day periods of care per unique HHA 
user is similar per 30-day periods of care between CY 2022 and CY 2023. 
The data also show a decreasing trend in the overall number of 30-day 
periods of care between CY 2018 and CY 2023. Table 2 shows utilization 
of visits per 30-day period of care by home health discipline over 
time. Table 2 shows the proportion of 30-day periods of care that are 
LUPAs and the average number of visits per discipline of those LUPA 30-
day periods of care over time. The data show a

[[Page 55319]]

decreasing trend in the average number of visits per 30-day period and 
average number of visits per discipline for LUPA 30-day periods of care 
between CY 2018 and CY 2023.
[GRAPHIC] [TIFF OMITTED] TP03JY24.003

[GRAPHIC] [TIFF OMITTED] TP03JY24.004


[[Page 55320]]


[GRAPHIC] [TIFF OMITTED] TP03JY24.005

b. Analysis of 2022 Cost Report Data for 30-Day Periods of Care
    In the CY 2024 HH PPS proposed rule (88 FR 43664), we provided a 
summary of analysis on FY 2021 HHA cost report data, as this was the 
most recent and complete cost report data at the time of rulemaking, 
and CY 2022 claims to estimate 30-day period of care costs. Our 
analysis showed that the CY 2022 national, standardized 30-day period 
payment rate of $2,031.64 was approximately 45 percent more than the 
estimated CY 2022 estimated 30-day period cost of $1,402.27.
    Using this same process in this proposed rule to compare home 
health payment to costs, we examined 2022 HHA Medicare cost reports, as 
this is the most recent and complete cost report data at the time of 
rulemaking, and CY 2023 home health claims, to estimate 30-day period 
of care costs. We excluded LUPAs and visits with partial episode 
payments (PEPs) when calculating the average number of visits. The 2022 
average NRS costs per visit is $4.38. To update the estimated 30-day 
period of care costs, we begin with the 2022 average costs per visit 
with NRS for each discipline and multiply that amount by the CY 2023 
home health payment update factor of 1.04. That amount for each 
discipline is then multiplied by the 2023 average number of visits by 
discipline to determine the 2023 Estimated 30-day Period Costs. Table 5 
shows the estimated average costs for 30-day periods of care by 
discipline with NRS and the total estimated 30-day period of care costs 
with NRS for CY 2023.
[GRAPHIC] [TIFF OMITTED] TP03JY24.006


[[Page 55321]]


    The CY 2023 national standardized 30-day period payment rate was 
$2,010.69, which is approximately 32 percent more than the estimated CY 
2023 30-day period average facility cost of $1,527.23. In its March 
2024 Report to Congress, MedPAC assumed costs will increase by only 
0.55 percent, the average of the increases in costs per 30-day period 
for 2021 and 2022.\1\ Furthermore, MedPAC noted that for more than a 
decade, payments under the HH PPS have significantly exceeded HHAs' 
costs. MedPAC also noted an increase of 4.0 percent in the costs per 
30-day period for freestanding HHAs in 2022, a reversal of the trend 
for 2021, where costs per 30-day period decreased by 2.9 percent. This 
increase in 2022 was due to higher costs per visit, but it was offset 
by a reduction in the number of in-person visits per 30-day period. As 
shown in table 5 in this proposed rule, HHAs have reduced visits under 
the PDGM in CY 2022.
---------------------------------------------------------------------------

    \1\ Report to Congress, Medicare Payment Policy. Home Health 
Care Services, Chapter 7. MedPAC. March 2024 (https://www.medpac.gov/wp-content/uploads/2024/03/Ch7_Mar24_MedPAC_Report_To_Congress_SEC.pdf).
---------------------------------------------------------------------------

c. Clinical Groupings and Comorbidities
    Each 30-day period of care is grouped into one of 12 clinical 
groups, which describe the primary reason for which a patient is 
receiving home health services under the Medicare home health benefit. 
The clinical grouping is based on the principal diagnosis reported on 
the home health claim. Table 6 shows the distribution of the 12 
clinical groups over time.
[GRAPHIC] [TIFF OMITTED] TP03JY24.007

    Thirty-day periods of care will receive a comorbidity adjustment 
category based on the presence of certain secondary diagnoses reported 
on home health claims. These diagnoses are based on a home health 
specific list of clinically and statistically significant secondary 
diagnosis subgroups with similar resource use. We refer readers to 
section II.B.4.c. of this proposed rule and the CY 2020 final rule with 
comment period (84 FR 60493) for further information on the comorbidity 
adjustment categories. Home health 30-day periods of care can receive a 
low or a high comorbidity adjustment, or no comorbidity adjustment. 
Table 7 shows the distribution of 30-day periods of care by comorbidity 
adjustment category for all 30-day periods.

[[Page 55322]]

[GRAPHIC] [TIFF OMITTED] TP03JY24.008

d. Admission Source and Timing
    Each 30-day period of care is classified into one of two admission 
source categories--community or institutional--depending on what 
healthcare setting was utilized in the 14 days prior to receiving home 
health care. Thirty-day periods of care for beneficiaries with any 
inpatient acute care hospitalizations, inpatient psychiatric facility 
(IPF) stays, skilled nursing facility (SNF) stays, inpatient 
rehabilitation facility (IRF) stays, or long-term care hospital (LTCH) 
stays within 14 days prior to a home health admission will be 
designated as institutional admissions. The institutional admission 
source category will also include patients that had an acute care 
hospital stay during a previous 30-day period of care and within 14 
days prior to the subsequent, contiguous 30-day period of care and for 
which the patient was not discharged from home health and readmitted.
    Thirty-day periods of care are classified as ``early'' or ``late'' 
depending on when they occur within a sequence of 30-day periods of 
care. The first 30-day period of care is classified as early and all 
subsequent 30-day periods of care in the sequence (second or later) are 
classified as late. A subsequent 30-day period of care would not be 
considered early unless there is a gap of more than 60 days between the 
end of one previous period of care and the start of another. 
Information regarding the timing of a 30-day period of care comes from 
Medicare home health claims data and not the OASIS assessment to 
determine if a 30-day period of care is ``early'' or ``late''. Table 8 
shows the distribution of 30-day periods of care by admission source 
and timing.
[GRAPHIC] [TIFF OMITTED] TP03JY24.009

e. Functional Impairment Level
    Each 30-day period of care is placed into one of three functional 
impairment levels (low, medium, or high) based on responses to certain 
OASIS functional items associated with grooming, bathing, dressing, 
ambulating, transferring, and risk for hospitalization. The specific 
OASIS items that are used for the functional impairment level are found 
in table 8 in the CY 2020 HH PPS final rule with comment period (84 FR 
60490).\2\ Responses to these OASIS items are grouped together into 
response categories with similar resource use and each response 
category has associated points. A more detailed description as to how 
these response categories were established can be found in the 
technical report, ``Overview of the Home Health Groupings Model'' 
posted on the HHA web page.\3\ The sum of these points results in a 
functional

[[Page 55323]]

impairment score used to group 30-day periods of care into a functional 
impairment level with similar resource use. The scores associated with 
the functional impairment levels vary by clinical group to account for 
differences in resource utilization. A patient's functional impairment 
level will remain the same for the first and second 30-day periods of 
care unless there is a significant change in condition that warrants an 
``other follow-up'' assessment prior to the second 30-day period of 
care. For each 30-day period of care, the Medicare claims processing 
system will look for occurrence code 50 on the claim to correspond to 
the M0090 date of the applicable assessment. Table 9 shows the 
distribution of 30-day periods by functional impairment level.
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    \2\ CMS continues to use the M1800-1860 items to determine 
functional impairment level for case mix purposes while we continue 
to analyze the relationship between the analogous GG items (required 
as standardized patient assessment data) and the M1800 items used 
for payment.
    \3\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.
[GRAPHIC] [TIFF OMITTED] TP03JY24.010

f. Therapy Visits
    Beginning in CY 2020, section 1895(b)(4)(B)(ii) of the Act 
eliminated the use of therapy thresholds in calculating payments for CY 
2020 and subsequent years. Prior to implementation of the PDGM, HHAs 
could receive an adjustment to payment based on the number of therapy 
visits provided during a 60-day episode of care. We examined the 
proportion of actual 30-day periods of care with and without therapy 
visits. To be covered as skilled therapy, the services must require the 
skills of a qualified therapist (that is, PT, OT, or SLP) or qualified 
therapist assistant and must be reasonable and necessary for the 
treatment of the patient's illness or injury.\4\ As shown in table 10, 
we monitor the number of visits per 30-day period of care by each home 
health discipline. Any 30-day period of care can include both therapy 
and non-therapy visits. If any 30-day period of care consisted of only 
visits for PT, OT, and/or SLP, then this 30-day period of care is 
considered ``therapy only''. If any 30-day period of care consisted of 
only visits for skilled nursing, home health aide, or social worker, 
then this 30-day period of care is considered ``no therapy''. If any 
30-day period of care consisted of at least one therapy visit and one 
non-therapy, then this 30-day period of care is considered ``therapy + 
non-therapy''. Table 10 shows the proportion of 30-day periods of care 
with only therapy visits, at least one therapy visit and one non-
therapy visit, and no therapy visits. Figure 2 shows the proportion of 
30-day periods of care by the number of therapy visits (excluding zero) 
provided during 30-day periods of care.
---------------------------------------------------------------------------

    \4\ Medicare Benefit Policy Manual, Chapter 7 Home Health 
Services, Section 40.2 Skilled Therapy Services (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf).
[GRAPHIC] [TIFF OMITTED] TP03JY24.011


[[Page 55324]]


[GRAPHIC] [TIFF OMITTED] TP03JY24.012

    Both table 10 and figure 2, as previously discussed, indicate there 
have been changes in the distribution of both therapy and non-therapy 
visits in CY 2023 compared to CY 2022. For example, the percent of 30-
day periods with one through seven therapy visits during a 30-day 
period increased in CY 2023 compared to CY 2022. Comparing therapy 
utilization from before the PDGM (CYs 2018 and 2019) to after the 
implementation of the PDGM (CYs 2020-2023), we have also seen a decline 
in therapy visits across all clinical groups, as shown in figure 2.

[[Page 55325]]

[GRAPHIC] [TIFF OMITTED] TP03JY24.013

    We also examined the proportion of 30-day periods of care with and 
without skilled nursing, social work, or home health aide visits. Table 
12 shows the number of 30-day periods of care with only skilled nursing 
visits, at least one skilled nursing visit and one other visit type 
(therapy or non-therapy), and no skilled nursing visits. Table 12 shows 
the number of 30-day periods of care with and without home health aide 
and/or social worker visits.

[[Page 55326]]

[GRAPHIC] [TIFF OMITTED] TP03JY24.014

[GRAPHIC] [TIFF OMITTED] TP03JY24.015

g. Home Health Services Using Telecommunications Technology
    As discussed in the CY 2023 final rule (87 FR 66858), we began 
collecting data on the use of telecommunications technology used during 
a home health period using three new G-codes reported on home health 
claims. Collecting data on services furnished via telecommunications 
technology on claims allows CMS to analyze the characteristics of 
patients using services provided remotely and have a broader 
understanding of the social determinants that affect who benefits most 
from these services, including what barriers may potentially exist for 
certain subsets of patients. The monitoring discussion illustrates 
which services are most frequently furnished via telecommunication 
technology and generally how long remote patient monitoring is 
utilized.
    We began collecting this information from HHAs on January 1, 2023, 
on a voluntary basis and have required this information to be reported 
on claims starting on July 1, 2023 (87 FR 66858). The three new G-codes 
help identify when home health services are furnished using synchronous 
telemedicine rendered via a real-time two-way audio and video 
telecommunications system (G320); synchronous telemedicine rendered via 
telephone or other real-time interactive audio-only telecommunications 
system (G0321); and the collection of physiologic data digitally stored 
and/or transmitted by the patient to the home health agency, that is, 
remote patient monitoring (G0322). We capture the usage and length of 
remote patient monitoring using the start date of the remote patient 
monitoring and the number of days of monitoring indicated on the claim. 
We also looked at the disciplines most often providing remote patient 
monitoring. We examined the utilization of telecommunications 
technology device during a home health period and remote patient 
monitoring by looking at home health claims that included the three G-
codes. Tables 14 and 15 shows that the use of telecommunications 
services reported on CY 2023 home health claims are low (roughly 1 
percent of all CY 2023 claims) and are mainly associated with skilled 
nursing.

[[Page 55327]]

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[GRAPHIC] [TIFF OMITTED] TP03JY24.017

BILLING CODE 4120-01-C
    We will continue to monitor the provision of home health services, 
including any changes in the number and duration of home health visits, 
composition of the disciplines providing such services, 
telecommunications technology used during home health periods, and 
overall home health payments to determine if refinements to the case-
mix adjustment methodology or other policies may be needed in the 
future.

C. Proposed CY 2025 Payment Adjustments Under the HH PPS

1. Proposed Behavior Assumption Adjustments Under the HH PPS

a. Background

    As discussed in section II.A.1. of this proposed rule, starting in 
CY 2020, the Secretary was statutorily required by section 
1895(b)(2)(B) of the Act, to change the unit of payment under the HH 
PPS from a 60-day episode of care to a 30-day period of care. CMS was 
also required to make assumptions about behavior changes that could 
occur as a result of the implementation of the 30-day unit of payment 
and the case-mix adjustment factors that eliminated the use of therapy 
thresholds. In the CY 2019 HH PPS final rule with comment period (83 FR 
56455), we finalized three behavior change assumptions which were also 
described in the CY 2022 and 2023 HH PPS rules (86 FR 35890, 87 FR 
37614, and 87 FR 66795 through 66796). In the CY 2020 HH PPS final rule 
with comment period (84 FR 60519), we included these 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

[[Page 55328]]

assumed behavior changes did occur as a result of the implementation of 
the PDGM and that other behaviors, such as changes in the provision of 
therapy and changes in functional impairment levels also occurred. We 
also reminded readers that in the CY 2020 HH PPS final rule with 
comment period (84 FR 60513) we stated we interpret actual behavior 
changes to encompass both behavior changes that were previously 
outlined as assumed by CMS, and other behavior changes not identified 
at the time the budget-neutral 30-day payment rate for CY 2020 was 
established. In the CY 2023 HH PPS final rule (87 FR 66796) we provided 
supporting evidence that indicated the number of therapy visits 
declined in CYs 2020 and 2021, as well as a slight decline in therapy 
visits beginning in CY 2019 after the finalization of the removal of 
therapy thresholds, but prior to implementation of the PDGM. In section 
II.B.1. of this proposed rule, our analysis continues to show overall 
the actual 30-day periods are similar to the simulated 30-day periods 
and there continues to be a decline in therapy visits, indicating that 
HHAs changed their behavior to reduce therapy visits. Although the 
analysis demonstrates evidence of individual behavior changes (for 
example, in the volume of visits for LUPAs, therapy sessions, etc.), we 
use the entirety of the behaviors in order to calculate estimated 
aggregate expenditures. The law instructs us to ensure that estimated 
aggregate expenditures under the PDGM are equal to the estimated 
aggregate expenditures that otherwise would have been made under the 
prior system.
    Section 4142(a) of the CAA, 2023, required CMS to present, to the 
extent practicable, a description of the actual behavior changes 
occurring under the HH PPS from CYs 2020-2026. This subsection of the 
CAA, 2023, also required CMS to provide datasets underlying the 
simulated 60-day episodes and discuss and provide time for stakeholders 
to provide input and ask questions on the payment rate development for 
CY 2023. CMS complied with these requirements by posting online both 
the supplemental 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 are 
proposing to add new assumptions in the first step (creating simulated 
60-day episodes from 30-day periods These new 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. 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 follow-up 
assessments as shown in the following figure 3.
BILLING CODE 4120-01-P

[[Page 55329]]

[GRAPHIC] [TIFF OMITTED] TP03JY24.018

    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 4, ask about therapies 
(M1030), vision (M1200), and the frequency of pain interfering with 
activity (M1242). Additionally, these three items are only asked at 
SOC/ROC and not follow-up.

[[Page 55330]]

[GRAPHIC] [TIFF OMITTED] TP03JY24.019

    The differences in these three items from what is included in 
OASIS-E necessitate a mapping methodology to impute the OASIS-D 
responses using OASIS-E to create simulated 60-day episodes under the 
153-group case mix system from 30-day periods under the PDGM. 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 believes the following two proposals on assumptions are the 
most appropriate 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 are proposing not to impute the 13 items. If the 
simulated 60-day episode matches to a follow-up assessment, then we are 
proposing 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 would 
limit the look back period to the beginning of the calendar year that 
precedes the calendar year for the claim. For example, a simulated 60-
day episode with a follow-up assessment on June 1, 2023, would have a 
look-back period 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 are proposing 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 are proposing to use the OASIS-D for responses. If 
the simulated 60-day episode matches to an OASIS-E assessment, we are 
proposing to apply 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 are 
also proposing to apply the look-back period as described in the 
assumption earlier when necessary.

[[Page 55331]]

[GRAPHIC] [TIFF OMITTED] TP03JY24.020

    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] TP03JY24.021


[[Page 55332]]


    On the OASIS-D there was one pain item (M1242--Frequency of Pain 
Interfering with patient's activity or movement) used for payment 
policy. 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 
believe 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 has a response 
of ``occasionally'', then we would use the response from J0520 
(``frequently'') for mapping as this is the most severe response. 
Figure 7 shows the proposed mapping based on the maximum severity 
response for any of the three pain items.
[GRAPHIC] [TIFF OMITTED] TP03JY24.022

BILLING CODE 4120-01-C
    As this overall methodology was previously finalized in the CY 2023 
HH PPS final rule (87 FR 66804) and we are just proposing technical 
updates based on the updated OASIS instrument, CMS will continue 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 methodology with detailed 
instructions for each step. We are soliciting comments on these new 
proposed assumptions related to mapping of the OASIS-E items.
c. Calculating Permanent and Temporary Payment Adjustments
    To offset prospectively for such increases or decreases in 
estimated aggregate expenditures as a result of the impact of 
differences between assumed behavior changes and actual behavior 
changes, in any given year, we calculate a permanent prospective 
adjustment by calculating the percent change between the actual 30-day 
base payment rate and the recalculated 30-day base payment rate. This 
percent change is converted into 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 calculate a temporary prospective 
adjustment by calculating the dollar amount difference between the 
estimated aggregate expenditures from all 30-day periods using the 
recalculated 30-day base payment rate, and the aggregate expenditures 
for all 30-day periods using the actual 30-day base payment rate for 
the same year. In other words, when determining the temporary 
retrospective dollar amount, we use the full dataset of actual 30-day 
periods using both the actual and recalculated 30-day base payment 
rates to ensure that the utilization and distribution of claims are the 
same. In accordance with section 1895(b)(3)(D)(iii) of the Act, the 
temporary adjustment is to be applied on a prospective basis and shall 
apply only with respect to the year for which such temporary increase 
or decrease is made. Therefore, after we determine the dollar amount to 
be reconciled in any given year, we calculate a temporary adjustment 
factor to be applied to the base payment rate for that year. The 
temporary adjustment factor is based on an estimated number of 30-day 
periods in the next year using historical data trends, and as 
applicable, we control for a permanent adjustment factor, case-mix 
weight recalibration neutrality factor, wage index budget neutrality 
factor, and the home health payment update. The temporary adjustment 
factor is applied last. 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.
d. CY 2023 Preliminary Claims Results
    We will continue the practice of using the most recent complete 
home health claims data available at the time of rulemaking. While the 
CY 2023 analysis presented in this proposed rule is the most complete 
data available at the time of this proposed rule, it is considered 
preliminary and, as more data become available from the latter half of 
CY 2023, we will update our results in the final rule. The CY 2025 
final rule will utilize the CY 2023 finalized data for determining any 
permanent adjustment needed to the CY 2025 payment rate. However, while 
the claims data and the

[[Page 55333]]

permanent and temporary adjustment results will be considered complete, 
any adjustments to future payment rates may be subject to additional 
considerations such as permanent adjustments taken in previous years.
    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 
proposed 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 proposed HH PPS LDS file. Access will be granted 
for both the 30-day periods and the simulated 60-day episodes under one 
DUA. Visit the HH PPS LDS web page for more information.\5\ In 
addition, the proposed CY 2025 Home Health Descriptive Statistics from 
the LDS Files spreadsheet is available on the HH PPS Regulations and 
Notices webpage,\6\ 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.
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    \5\ https://www.cms.gov/research-statistics-data-and-systems/files-for-order/limiteddatasets/home_health_pps_lds.
    \6\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.
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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 
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 preliminary CY 2023 dataset, we began with 8,133,377 30-
day periods of care and dropped 452,253 30-day periods of care that had 
claim occurrence code 50 date after October 31, 2023. We also excluded 
866,293 30-day periods of care that had claim occurrence code 50 date 
before January 1, 2023, to ensure the 30-day period would 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 additional 12,906 30-day periods were 
excluded.
    Additionally, we excluded 166,441 simulated 60-day episodes of care 
where no OASIS information was available in the CCW VRDC, a recent SOC/
ROC OASIS was not available, or the episode could not be grouped to a 
HIPPS due to a missing primary diagnosis or other reason. Our simulated 
60-day episodes of care produced a distribution of two 30-day periods 
of care (68.9 percent) and single 30-day periods of care (31.1 percent) 
that was similar to what we found when we simulated two 30-day periods 
of care for implementation of the PDGM. After all exclusions and 
assumptions were applied, the final dataset for this proposed rule 
included 6,494,947 actual 30-day periods of care and 3,845,954 
simulated 60-day episodes of care for CY 2023.
    Using the preliminary dataset for CY 2023 (6,494,947 actual 30-day 
periods which made up the 3,845,954 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 $1,873.17 based on actual behavior, as 
shown in table 16 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 full -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 weights 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 ($1,873.17). 
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 preliminary claims data are shown in table 16.

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    As shown in table 16, a permanent prospective adjustment of -1.125 
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. 
To illustrate this calculation:
[GRAPHIC] [TIFF OMITTED] TP03JY24.024

    Additionally, we determined that our initial estimate of the base 
payment rate ($2,010.69) resulted in excess expenditures of 
approximately $966 million in CY 2023. This would require a temporary 
adjustment, where the dollar amount ($966 million) would be converted 
to a factor when implemented, to offset for such increases in estimated 
aggregate expenditures for CY 2023.
f. Proposed CY 2025 Permanent Adjustment and Temporary Adjustment 
Calculations
    In the preceding section we describe how we annually analyzed CY 
2023 preliminary data to determine the effects of actual behavior 
change on estimated aggregate expenditures. Again, that analysis 
included simulations that assumed that the full payment adjustment (-
5.779 percent) was already taken. We note that CMS did not implement 
the full payment adjustment, so the calculations set forth later in 
this section reflect the lagging adjustments that are still needed.
    That is, the calculation in this section includes any of the 
remaining adjustments not applied in previous years (that is, CYs 2020 
to 2022), 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 16, we do not assume the full adjustment from prior 
years had been taken.
    As discussed in section II.C.1.d. of this proposed rule, using the 
preliminary dataset for CY 2023 (6,494,947 actual 30-day periods which 
made up the 3,845,954 simulated 60-day episodes) we determined the CY 
2023 30-day base payment rate should have been $1,873.17 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 17, 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 $1,873.17 (based on actual behaviors) 
is the total permanent adjustment need for CYs 2020 through 2023.

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    As shown in table 17, a permanent prospective adjustment of -6.839 
percent to the CY 2025 30-day payment rate for CYs 2020 through 2023 
would be required to offset for such increases in estimated aggregate 
expenditures in future years. To illustrate this calculation:
[GRAPHIC] [TIFF OMITTED] TP03JY24.026

    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 would 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 17, a 
permanent prospective adjustment of -6.839 percent to the CY 2025 30-
day payment rate would 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 would 
include estimated aggregate expenditures in CY 2023, by simply 
subtracting the -2.890 percent applied in CY 2024 from the total 
permanent adjustment of -6.839 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-[chi]) = (1-0.06839). To 
illustrate this calculation we used the following approach.
[GRAPHIC] [TIFF OMITTED] TP03JY24.027

    We are required by law \7\ 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 4 years of claims data under the PDGM, as well as 1 year with 
a partial permanent adjustment applied. In previous years' rules, we 
provided the permanent adjustment calculated for each discrete year of 
claims.
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    \7\ Sections 1895(b)(3)(D)(i) and 1895(b)(3)(D)(ii) of the Act.
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    Permanent Adjustments Calculated:

CY 2020 Claims = -6.52% (87 FR 66805)
CY 2021 Claims = -1.42% (87 FR 66806)
CY 2022 Claims = -1.767% (88 FR 77692)
CY 2023 Claims = -1.125% (Table 16)

    Permanent Adjustments Applied:

CY 2023 Rate = -3.925% (88 FR 66808)
CY 2024 Rate = 2.890% (88 FR 77697)

    Accounting for the previous permanent adjustments applied to the 
30-day payment rate in CYs 2023 and 2024, we can simulate the permanent 
adjustment calculation with the simulated annual permanent adjustment 
percentage shown previously for CY 2025:

(1-0.0652)(1-0.0142)(1-0.01767)(1-0.01125) = (1-0.03925)(1-0.0289)(1-
x).
Solving, x = 4.067%.

    In table 18 we provide the base payment rate for assumed behaviors 
(simulates all prior adjustments were taken), the recalculated base 
payment rate for actual behaviors, the annual permanent adjustments 
calculated (assuming prior adjustments had been taken), the cumulative 
permanent adjustments calculated in each year, the final permanent 
adjustments implemented in rulemaking, and the temporary adjustment 
dollar amount based on actual payment rates.
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BILLING CODE 4120-01-C
    In both the CY 2023 and 2024 final rules (87 FR 66790, 88 FR 
77696), we acknowledged that the full permanent adjustment may be 
burdensome for some providers. In those final rules, we finalized only 
half of the permanent adjustment percentages (-3.925 percent in CY 2023 
and -2.890 percent in CY 2024). However, in this proposed rule, we are 
proposing to apply the full current remaining permanent adjustment of -
4.067 percent in CY 2025, as this would 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. In addition, we explained in the CY 2023 HH PPS 
final rule (87 FR 66808) and the CY 2024 HH PPS final rule (88 FR 
77697) that when we applied a reduced permanent adjustment in CY 2023 
and CY 2024, that we would need to continue to implement a reduction in 
future years to satisfy the statutory requirements. Therefore, we 
believe that CMS has been clear through notice and

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comment rulemaking that the remainder of these permanent adjustments 
would be applied, thereby giving HHAs adequate notice to prepare for 
this year's proposed rate reduction. Accordingly, we are proposing to 
apply the full remaining permanent adjustment of -4.067 percent to the 
CY 2025 home health base payment rate, noting that we will update this 
percentage using more complete claims data in the final rule.
    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 this proposed rule, 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. That is, the 
temporary adjustment dollar amount (currently estimated at $4.5 
billion) will be converted to a factor to be applied to the payment 
rate in a time and manner determined appropriate. As we noted in the CY 
2023 HH PPS proposed rule (87 FR 37682) and CY 2024 HH PPS proposed 
rule (88 FR 43678), we recognize that implementing both the permanent 
and temporary adjustments in the same year may adversely affect HHAs. 
Given that the magnitude of both the temporary and permanent 
adjustments together for CY 2025 rate setting may result in a 
significant reduction of the payment rate, we are not proposing to take 
the temporary adjustment in CY 2025. In future year rulemaking, we will 
propose a temporary adjustment factor to the national, standardized 
base payment rate in a time and manner determined appropriate. As noted 
previously, we will update these permanent and temporary adjustments in 
the final rule to reflect more complete claims data for CY 2023. We 
solicit comments on the proposal to apply a -4.067 percent permanent 
adjustment to the CY 2025 base payment rate.

D. Proposed 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. Proposed 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.C.4.f.2 of this proposed rule. For example, if 
the LUPA visit threshold is four, and a 30-day period of care has four 
or more visits, it is paid the full 30-day period payment amount; if 
the period of care has three or 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 would be reevaluated every year based on the most current 
utilization data available at the time of rulemaking. However, as CY 
2020 was the first year of the new case-mix adjustment methodology, we 
stated in the CY 2021 HH PPS final rule (85 FR 70305, 70306) that we 
would maintain the LUPA thresholds that were finalized and shown in 
table 17 of the CY 2020 HH PPS final rule with comment period (84 FR 
60522) for CY 2021 payment purposes. We stated that at that time, we 
did not have sufficient CY 2020 data to reevaluate the LUPA thresholds 
for CY 2021.
    In the CY 2022 HH PPS final rule with comment period (86 FR 62249), 
we finalized the proposal to recalibrate the PDGM case-mix weights, 
functional impairment levels, and comorbidity subgroups while 
maintaining the LUPA thresholds for CY 2022. We stated that because 
there are several factors that contribute to how the case-mix weight is 
set for a particular case-mix group (such as the number of visits, 
length of visits, types of disciplines providing visits, and non-
routine supplies) and the case-mix weight is derived by comparing the 
average resource use for the case-mix group relative to the average 
resource use across all groups, we believe the COVID-19 PHE would have 
impacted utilization within all case-mix groups similarly. Therefore, 
the impact of any reduction in resource use caused by the PHE on the 
calculation of the case-mix weight would be minimized since the impact 
would be accounted for both in the numerator and denominator of the 
formula used to calculate the case-mix weight. However, in contrast, 
the LUPA thresholds are based on the number of overall visits in a 
particular case-mix group (the threshold is the 10th percentile of 
visits or 2 visits, whichever is greater) instead of a relative value 
(like what is used to generate the case-mix weight) that would control 
for the impacts of the COVID-19 PHE. We noted that visit patterns and 
some of the decrease in overall visits in CY 2020 may not be 
representative of visit patterns in CY 2022. Therefore, to mitigate any 
potential future and significant short-term variability in the LUPA 
thresholds due to the COVID-19 PHE, we finalized the proposal to 
maintain the LUPA thresholds finalized and displayed in table 17 in the 
CY 2020 HH PPS final rule with comment period (84 FR 60522) for CY 2022 
payment purposes.
    For CY 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 are proposing to update the LUPA thresholds using 
CY 2023 home health claims utilization data (as of March 19, 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. 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 are listed in 
table 20. We solicit public comments on the proposed updates to the 
LUPA thresholds for CY 2025. The proposed LUPA thresholds will be 
updated based on more complete CY 2023 claims data in the final rule.
2. Proposed 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

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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 propose 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 these functional impairment levels using the OASIS 
items. We are proposing to use the same methodology previously 
finalized to update the functional impairment levels for CY 2025. The 
updated OASIS functional points table and the table of functional 
impairment levels by clinical group for CY 2025 are listed in tables 20 
and 21, respectively. We solicit public comments on the updates to 
functional points and the functional impairment levels by clinical 
group.
BILLING CODE 4120-01-P
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3. Proposed 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

[[Page 55340]]

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 would continue to examine the relationship of 
reported comorbidities on resource utilization and make the appropriate 
payment refinements to help ensure that payment is in alignment with 
the actual costs of providing care. For CY 2025, we propose 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 (as of March 19, 2024).
    For CY 2025, we propose to update the comorbidity subgroups to 
include 22 low comorbidity adjustment subgroups as identified in table 
22 and 90 high comorbidity adjustment interaction subgroups as 
identified in table 23. The proposed 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.
    We invite comments on the proposed updates to the low comorbidity 
adjustment subgroups and the high comorbidity adjustment interactions 
for CY 2025.
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4. Proposed 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). These data are the most current and complete data available at 
this time. We believe that recalibrating the case-mix weights using 
data from CY 2023 would be reflective of PDGM utilization and patient 
resource use for CY 2025. The proposed recalibrated case-mix weights 
will be updated based on more complete CY 2023 claims data in the final 
rule.
    The claims data provide visit-level data and data on whether non-
routine supplies (NRS) were provided during the period and the total 
charges of NRS. We determine the case-mix weight for each of the 432 
different PDGM payment groups by regressing resource use on a series of 
indicator variables for each of the categories using a fixed effects 
model as described in the following steps:
    Step 1: Estimate a regression model to assign a functional 
impairment level to each 30-day period. The regression model estimates 
the relationship between a 30-day period's resource use and the 
functional status and risk of hospitalization items included in the 
PDGM, which are obtained from certain OASIS items. We refer readers to 
table 18 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 numbers 
for the functional status and risk of hospitalization items that are 
applicable to each 30-day period. Next, each 30-day period is assigned 
to a functional impairment level (low, medium, or high) depending on 
the 30-day period's total functional score. Each clinical group has a 
separate set of functional thresholds used to assign 30-day periods 
into a low, medium or high functional impairment level. We set those 
thresholds so that we assign roughly a third of 30-day periods within 
each clinical group to each functional impairment level (low, medium, 
or high).
    Step 2: A second regression model estimates the relationship 
between a 30-day period's resource use and indicator variables for the 
presence of any of the comorbidities and comorbidity interactions that 
were originally examined for inclusion in the PDGM. Like the first 
regression model, this model also includes home health agency level 
fixed effects and includes control variables for each 30-day period's 
admission source, clinical group, timing, and functional impairment 
level. After we estimate the model, we assign comorbidities to the low 
comorbidity adjustment if any comorbidities have a coefficient that is 
statistically significant (p-value of 0.05 or less) and which have a 
coefficient that is larger than the 50th percentile of positive and 
statistically significant comorbidity coefficients. If two 
comorbidities in the model and their interaction term have coefficients 
that sum together to exceed $150 and the interaction term is 
statistically significant (p-value of 0.05 or less), we assign the two 
comorbidities together to the high comorbidity adjustment.
    Step 3: After Step 2, each 30-day period is assigned to a clinical 
group, admission source category, episode timing category, functional 
impairment level, and comorbidity adjustment category. For each 
combination of those variables (which represent the 432 different 
payment groups that comprise the PDGM), we then calculate the 10th 
percentile of visits across all 30-day periods within a particular 
payment group. If a 30-day period's number of visits is less than the 
10th percentile for their payment group, the 30-day period is 
classified as a Low Utilization Payment Adjustment (LUPA). If a payment 
group has a 10th percentile of visits that is less than two, we set the 
LUPA threshold for that payment group to be equal to two. That means if 
a 30-day period has one visit, it is classified as a LUPA and if it has 
two or more visits, it is not classified as a LUPA.
    Step 4: Take all non-LUPA 30-day periods and regress resource use 
on the 30-day period's clinical group, admission source category, 
episode timing category, functional impairment level, and comorbidity 
adjustment category. The regression includes fixed effects at the level 
of the home health agency. After we estimate the model, the model 
coefficients are used to predict each 30-day period's resource use. To 
create the case-mix weight for each 30-day period, the predicted 
resource use is divided by the overall resource use of the 30-day 
periods used to estimate the regression.
    The case-mix weight is then used to adjust the base payment rate to 
determine each 30-day period's payment. Table 24 shows the coefficients 
of the payment regression used to generate the weights, and the 
coefficients divided by average resource use.
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    The case-mix weights proposed for CY 2025 are listed in table 25 
and will also be posted on the HHA Center web page \8\ upon display of 
this proposed rule.
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    \8\ HHA Center web page: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.

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BILLING CODE 4120-01-C
    Changes to the PDGM case-mix weights are implemented in a budget 
neutral manner by multiplying the CY 2025 national standardized 30-day

[[Page 55361]]

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 1.0035.
    We invite public comments on the CY 2025 proposed case-mix weights 
and proposed case-mix weight budget neutrality factor.
5. Suggested 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 
specify the 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 would 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 would 
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).

[[Page 55362]]

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. 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 are not proposing a reassignment of N30.00- 
(acute cystitis) at this time.

E. Proposed CY 2025 Home Health Payment Rate Updates

1. Proposed 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 would be 74.9 percent and the non-labor-related share 
would be 25.1 percent. A detailed description of how we rebased the HHA 
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 IGI's 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 is 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 is 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 is currently estimated to be 0.5 percentage point for CY 
2025. Therefore, the proposed productivity-adjusted CY 2025 home health 
market basket update is 2.5 percent (3.0 percent market basket 
percentage increase, reduced by a 0.5 percentage point productivity 
adjustment). Furthermore, we propose that if more recent data 
subsequently become available (for example, a more recent estimate of 
the market basket and/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.
    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 is 0.5 percent (2.5 percent minus 
2 percentage points).
    We invite public comment on our proposals for the CY 2025 home 
health market basket percentage increase and productivity adjustment.
2. Proposed Adoption of the CBSA Delineations for 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.

[[Page 55363]]

    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 0.8555. Bulletin No. 17-01 
is available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/bulletins/2017/b-17-01.pdf.
    On April 10, 2018, OMB issued OMB Bulletin No. 18-03, which 
superseded the August 15, 2017, OMB Bulletin No. 17-01. On September 
14, 2018, OMB issued OMB Bulletin No. 18-04 which superseded the April 
10, 2018, OMB Bulletin No. 18-03. These bulletins established revised 
delineations for Metropolitan Statistical Areas, Micropolitan 
Statistical Areas, and Combined Statistical Areas, and provided 
guidance on the use of the delineations of these statistical areas. A 
copy of OMB Bulletin No. 18-04 may be obtained at: https://www.bls.gov/bls/omb-bulletin-18-04-revised-delineations-of-metropolitan-statistical-areas.pdf.
    On March 6, 2020, OMB issued Bulletin No. 20-01, which provided 
updates to and superseded OMB Bulletin No. 18-04 that was issued on 
September 14, 2018. The attachments to OMB Bulletin No. 20-01 provided 
detailed information on the update to statistical areas since September 
14, 2018, and were based on the application of the 2010 Standards for 
Delineating Metropolitan and Micropolitan Statistical Areas to Census 
Bureau population estimates for July 1, 2017, and July 1, 2018. (For a 
copy of this bulletin, we refer readers to https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf.) In OMB Bulletin No. 20-
01, OMB announced one new Micropolitan Statistical Area, one new 
component of an existing Combined Statistical Area and changes to New 
England City and Town Area (NECTA) delineations. In the CY 2021 HH PPS 
final rule (85 FR 70298), we stated that if appropriate, we would 
propose any updates from OMB Bulletin No. 20-01 in future rulemaking. 
After reviewing OMB Bulletin No. 20-01, we have determined that the 
changes in Bulletin 20-01 encompassed delineation changes that would 
not affect the Medicare home health wage index for CY 2022. 
Specifically, the updates consisted of changes to NECTA delineations 
and the re-designation of a single rural county into a newly created 
Micropolitan Statistical Area. The Medicare home health wage index does 
not utilize NECTA definitions, and, as most recently discussed in the 
CY 2021 HH PPS final rule (85 FR 70298) we include hospitals located in 
Micropolitan Statistical areas in each State's rural wage index. In 
other words, these OMB updates did not affect any geographic areas for 
purposes of the HH PPS wage index calculation.
    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. As described in the CY 2023 HH PPS 
final rule (87 FR 66851 through 66853), we finalized a policy that the 
CY HH PPS wage index would include a 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 would not be 
less than 95 percent of its final wage index for CY 2022, regardless of 
whether the geographic area is part of an updated CBSA, and that for 
subsequent years, a geographic area's wage index would not be less than 
95 percent of its wage index calculated in the prior CY. 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 
proposed rule, if we adopt the proposed revised OMB delineations, we 
are also proposing 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 would 
increase the integrity of the HH PPS wage index by creating a more 
accurate representation of geographic variation in wage levels. We are 
proposing 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. This proposal is 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 FY 2005 
IPPS final rule (69 FR 49029 through 49032), we determined the best 
course of action would 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

[[Page 55364]]

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. 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). 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 are also proposing to continue to treat Micropolitan 
Areas as ``rural'' and to include Micropolitan Areas in the calculation 
of each state's rural wage index.
b. Change to County-Equivalents in the State of Connecticut
    In a June 6, 2022, Notice (87 FR 34235-34240), 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 have 
evaluated the change and are proposing 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 consistency with our established 
policy of adopting the most recent OMB updates. We are providing the 
following crosswalk in table 26 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] TP03JY24.052

c. Urban Counties That Would Become Rural
    Under the revised OMB statistical area delineations (based upon OMB 
Bulletin No. 23-01), a total of 53 counties (and county equivalents) 
that are currently considered urban would be considered rural beginning 
in CY 2025. Table 27 lists the 53 counties that would become rural if 
we adopt as final our proposal to implement the revised OMB 
delineations.
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[GRAPHIC] [TIFF OMITTED] TP03JY24.054

d. Rural Counties That Would 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 would be considered located 
in urban areas under the revised OMB delineations beginning in CY 2025. 
Table 28 lists the 54 counties that would be urban if we adopt as final 
our proposal to implement the revised OMB delineations.

[[Page 55367]]

[GRAPHIC] [TIFF OMITTED] TP03JY24.055

e. Urban Counties That Would Move to a Different Urban CBSA Under the 
Revised OMB Delineations
    In addition to rural counties becoming urban and urban counties 
becoming rural, several urban counties would 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 
would involve a change only in CBSA name or number, while the CBSA 
would continue to encompass the same constituent counties. For example, 
CBSA 35154 (New Brunswick-Lakewood, NJ) would experience both a change 
to its number and its name and become CBSA 29484 (Lakewood-New 
Brunswick, NJ), while all three of its constituent counties would 
remain the same. In other cases, only the name of the CBSA would be 
modified. Table 29 lists CBSAs that would change in name and/or CBSA 
number only, but the

[[Page 55368]]

constituent counties would not change (except in instances where an 
urban county became rural or a rural county became urban, as discussed 
in the previous section).
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[[Page 55369]]


[GRAPHIC] [TIFF OMITTED] TP03JY24.057

    In some cases, all urban counties from a CY 2024 CBSA would be 
moved and subsumed by another CBSA in CY 2025. Table 30 lists the CBSAs 
that, under our proposal to adopt the revised OMB statistical area 
delineations, would be subsumed by another CBSA.
[GRAPHIC] [TIFF OMITTED] TP03JY24.058

    In other cases, if we adopt the new OMB delineations, some counties 
would shift between existing and new CBSAs, changing the constituent 
makeup of the CBSAs. In another type of change, some CBSAs have 
counties that would 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 would move from CBSA 
47894 (Washington-Arlington-Alexandria, DC-VA-MD-WV) into CBSA 47764 
(Washington, DC-MD). Calvert County, MD would 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) would move into 
CBSA 11694 (Arlington-Alexandria-Reston, VA-WV). Finally, in some 
cases, a CBSA would lose counties to another existing CBSA if we adopt 
the new OMB delineations. For example, Grainger County, TN would move 
from CBSA 34100 (Morristown, TN) into CBSA 28940 (Knoxville, TN). Table 
31 lists the 73 urban counties that would move from one urban CBSA to a 
new or modified urban CBSA if we adopt the revised OMB delineations.

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[[Page 55372]]


BILLING CODE 4120-01-C
f. Proposed 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 would 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 would 
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 would not be less 
than 95 percent of its wage index calculated in the prior CY.
    For CY 2025, we believe 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 propose 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 would not 
experience more than a 5 percent decrease in wage index from the 
previous calendar year. Specifically, we are proposing for CY 2025, 
that the 5-percent cap would 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 propose 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. Specifically, some counties that change OMB designations 
would 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 would 
receive the cap would 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 are proposing 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 would 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 \9\ 
wage index transition codes would 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 
are proposing that Lamar County would 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 would 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, transition code 50003 
would be used on a home health claim instead of rural Georgia code 
99911.
---------------------------------------------------------------------------

    \9\ The remaining 3 characters of the code to be determined if 
finalized.
---------------------------------------------------------------------------

    We are also proposing 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 
would 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 would use 
transition code 50003 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 counties that will require a 
transition code and the corresponding 50XXX codes are shown in table 32 
and will also be shown in the last column of the CY 2025 HH PPS wage 
index file.
BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C
    The proposed 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 proposed revised OMB 
delineations that would be in effect in CY 2025 if these proposed 
changes are finalized. This file shows each state and county and its 
corresponding proposed wage index along with the previous CBSA number, 
the proposed CBSA number or proposed transition code, and the proposed 
CBSA name. The proposed 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-renewal/providers-suppliers/home-health-agency-center.
3. Proposed 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 propose 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 propose 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 proposed CY 2025 HH PPS wage index would not take 
into account any geographic reclassification of hospitals, including 
those in accordance with section 1886(d)(8)(B) or 1886(d)(10) of the 
Act but would include the 5-percent cap on wage index decreases.
    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 propose to 
continue to use the same

[[Page 55374]]

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 propose the CY 2025 wage index value for Hinesville, GA, would be 
0.8608.
    For rural areas that do not have inpatient hospitals, we propose to 
use the average wage index from all contiguous Core Based Statistical 
Areas (CBSAs) as a reasonable proxy. 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 this proposed rule, we are proposing 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 are proposing 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 
results in a proposed CY 2025 HH PPS wage index of 0.8334 for rural 
North Dakota.
[GRAPHIC] [TIFF OMITTED] TP03JY24.062

    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 would 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 are proposing 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 would 
equal 0.2520. However, because 0.2520 is more than a 5 percent decline 
in the CY 2024 wage index, the 5-percent cap would be applied. We are 
proposing 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 results in a proposed 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, would now have one 
rural area with a hospital from which hospital wage data can be 
derived. As such, the proposed CY 2025 wage index for rural Delaware 
would be 1.0429.
    The complete proposed CY 2025 wage index is available on the CMS 
website at: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
4. Proposed 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 subsequent years 
the labor-related share would be 74.9 percent and the non-labor-related 
share would be 25.1 percent. The following are the steps we take to 
compute the case-mix and wage-adjusted 30-day period payment amount for 
CY 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

[[Page 55375]]

and Sec.  484.225(i), for an HHA that does not submit home health 
quality data, as specified by the Secretary, the unadjusted national 
prospective 30-day period rate is equal to the rate for the previous 
calendar year increased by the applicable home health payment update 
percentage, minus 2 percentage points. Any reduction of the percentage 
change would apply only to the calendar year involved and would not be 
considered in computing the prospective payment amount for a subsequent 
calendar year. The final claim that the HHA submits for payment 
determines the total payment amount for the period and whether we make 
an applicable adjustment to the 30-day case-mix and wage-adjusted 
payment amount. The end date of the 30-day period, as reported on the 
claim, determines which calendar year rates Medicare will use to pay 
the claim. We may adjust a 30-day case-mix and wage-adjusted payment 
based on the information submitted on the claim to reflect the 
following:
     A LUPA is provided on a per-visit basis as set forth in 
Sec. Sec.  484.205(d)(1) and 484.230.
     A partial payment adjustment as set forth in Sec. Sec.  
484.205(d)(2) and 484.235.
     An outlier payment as set forth in Sec. Sec.  
484.205(d)(3) and 484.240.
(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 proposed 
rule, we are proposing to implement a permanent adjustment of -4.067 
percent to ensure that payments under the PDGM do not exceed what 
payments would have been under the 153-group payment system as required 
by law. The proposed permanent adjustment factor is 0.95933. 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 proposed case-mix weight budget 
neutrality factor for CY 2025 is 1.0035.
    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 proposed 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 proposed 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 0.9985. We then apply the wage index budget 
neutrality factor of 0.9985 to the 30-day period payment rate.
    Next, we propose to update the 30-day period payment rate by the 
proposed CY 2025 home health payment update percentage of 2.5 percent. 
The CY 2025 national standardized 30-day period payment rate is 
calculated in table 34.
BILLING CODE 4120-01-P
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    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 
proposed CY 2025 home health payment update percentage of 0.5 percent 
(2.5 percent minus 2 percentage points) and is shown in table 35.

[[Page 55376]]

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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 proposed 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 
0.9991. We apply the wage index budget neutrality factor in order to 
calculate the CY 2025 national per-visit rates.
    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 proposed CY 2025 
home health payment update percentage of 2.5 percent. The national per-
visit rates are adjusted by the wage index based on the site of service 
of the beneficiary. The per-visit payments for LUPAs are separate from 
the LUPA add-on payment amount, which is paid for episodes that occur 
as the only episode or initial episode in a sequence of adjacent 
episodes. The CY 2025 national per-visit rates for HHAs that submit the 
required quality data are updated by the proposed CY 2025 home health 
payment update percentage of 2.5 percent and are shown in table 36.
[GRAPHIC] [TIFF OMITTED] TP03JY24.065

    The CY 2025 per-visit payment rates for HHAs that do not submit the 
required quality data are updated by the proposed CY 2025 home health 
payment update percentage of 2.5 percent minus 2 percentage points and 
are shown in table 37.

[[Page 55377]]

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BILLING CODE 4120-01-C
d. LUPA Add-On Factors
    Prior to the implementation of the 30-day unit of payment, LUPA 
episodes were eligible for a LUPA add-on payment if the episode of care 
was the first or only episode in a sequence of adjacent episodes. As 
stated in the CY 2008 HH PPS final rule, the average visit lengths in 
these initial LUPAs are 16 to 18 percent higher than the average visit 
lengths in initial non-LUPA episodes (72 FR 49848). LUPA episodes that 
occur as the only episode or as an initial episode in a sequence of 
adjacent episodes are adjusted by applying an additional amount to the 
LUPA payment before adjusting for area wage differences.
    In the CY 2014 HH PPS final rule (78 FR 72305), we changed the 
methodology for calculating the LUPA add-on amount, 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. The analysis showed that the average excess 
of minutes for the first visit in LUPA episodes that were the only 
episode or an initial LUPA in a sequence of adjacent episodes are 37.27 
minutes for the first visit if SN, 31.69 minutes for the first visit if 
PT, and 31.56 minutes for the first visit if SLP. The average minutes 
for all non-first visits in non-LUPA episodes were 44.10 minutes for 
SN, 47.30 minutes for PT, and 50.37 minutes for SLP. To determine the 
final LUPA add-on factors for each discipline, we calculated 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. (Of 
note, the average excess minutes for the first visit in LUPA add-on 
claims equal, for each discipline, is equal to the average minutes for 
the first visit in LUPA add-on claims minus the average minutes for 
non-first visits in LUPA add-on claims.) We then added one to these 
ratios to obtain the respective 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.
    At this time, in an effort to enhance the accuracy and relevance of 
LUPA add-on factors to reflect current healthcare practices and costs, 
CMS is proposing to update 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. For this proposed rule, we are proposing 
to use the same methodology used to establish the LUPA add-on amount 
for CY 2014, using updated claims data.
    Specifically, we are proposing 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 doing so, the analysis 
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 30.00 minutes for the first visit if SN, 28.18 
minutes for the first visit if PT, and 31.59 minutes for the first 
visit if SLP. The average minutes for all non-first visits in non-LUPA 
episodes are 41.51 minutes for SN, 45.11 minutes for PT, and 47.13 
minutes for SLP. The following table 38 shows 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 proposed LUPA add-on factors, and the percent 
change between the current and the proposed LUPA add-on factors. This 
table also shows the proposed OT LUPA add-on factor outlined in section 
II.4.e. of this proposed rule as follows:

[[Page 55378]]

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    To determine the LUPA add-on factors for each discipline in 
relation to the aforementioned proposed 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 proposed add 
on factors: 1.7227 for SN; 1.6247 for PT; and 1.6703 for SLP. As an 
example of the application of the proposed add-on factors for CY 2025, 
for LUPA periods that occur as the only episode or an initial period in 
a sequence of adjacent periods, if the first skilled visit is SN, the 
payment for that visit would be $297.03 (1.7227 multiplied by $172.42). 
The proposed LUPA add-on factors will be updated based on more complete 
CY 2023 claims data in the final rule. As such, we solicit comments on 
the proposals to update the LUPA factors using the 2014 methodology and 
based on these updated numbers, re-price the LUPA payment amounts.
e. Occupational Therapy LUPA Add-On Factor
    In order to implement Division CC, section 115, of the 
Consolidation Appropriations Act (CAA), 2021, CMS finalized changes to 
regulations at Sec.  484.55(a)(2) and (b)(3) that allowed occupational 
therapists to conduct initial and comprehensive assessments for all 
Medicare beneficiaries under the home health benefit when the plan of 
care does not initially include skilled nursing care, but 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 that we would use the PT LUPA add-on factor of 
1.6700 as a proxy. We also stated in the CY 2022 final rule that we 
would use the PT LUPA add-on factor as a proxy until we have CY 2022 
data to establish a more accurate OT add-on factor for the LUPA add-on 
payment amounts (86 FR 62289). 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 this proposal.
    With sufficient recent claims data available, and to establish 
equitable compensation for all home health services, CMS is now 
proposing 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 this proposal, we are using 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 are updating the 
analysis using 100 percent of LUPA periods and a 100 percent sample of 
non-LUPA first periods from CY 2023 claims data. The analysis 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 33.40 minutes for the first visit. The average 
number of minutes for all non-first visits in non-LUPA periods is 45.97 
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 are proposing 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 are 
proposing to then add one to this ratio to obtain the proposed add on 
factor: 1.7266 for OT. As an example of the application of the proposed 
add-on factor, for LUPA periods that occur as the only period or as an 
initial period in a sequence of adjacent periods, if the first skilled 
visit is OT, the payment for that visit will be $327.62 (1.7266 
multiplied by $189.75). Table 38 shows the current LUPA add-on factors 
and the proposed LUPA add-on factors. The proposed OT LUPA add-on 
factor will be updated based on more complete CY 2023 claims data in 
the final rule. As such, we solicit comments on the proposed use of OT 
data to determine the OT LUPA add-on factor, as well as the proposed 
methodology to determine this OT LUPA add-on factor.
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

[[Page 55379]]

the wage and case-mix adjusted PPS episode amount and wage-adjusted FDL 
amount. The outlier payment is defined to be a proportion of the wage-
adjusted estimated cost that surpasses the wage-adjusted threshold. The 
proportion of additional costs over the outlier threshold amount paid 
as outlier payments is referred to as the loss-sharing ratio.
    As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through 
70399), section 3131(b)(1) of the Affordable Care Act amended section 
1895(b)(3)(C) of the Act to require that the Secretary reduce the HH 
PPS payment rates such that aggregate HH PPS payments were reduced by 5 
percent. In addition, section 3131(b)(2) of the Affordable Care Act 
amended section 1895(b)(5) of the Act by redesignating the existing 
language as section 1895(b)(5)(A) of the Act and revised the language 
to state that the total amount of the additional payments or payment 
adjustments for outlier episodes could not exceed 2.5 percent of the 
estimated total HH PPS payments for that year. Section 3131(b)(2)(C) of 
the Affordable Care Act also added section 1895(b)(5)(B) of the Act, 
which capped outlier payments as a percent of total payments for each 
HHA for each year at 10 percent.
    As such, beginning in CY 2011, we reduced payment rates by 5 
percent and targeted up to 2.5 percent of total estimated HH PPS 
payments to be paid as outliers. To do so, we first returned the 2.5 
percent held for the target CY 2010 outlier pool to the national, 
standardized 60-day episode rates, the national per visit rates, the 
LUPA add-on payment amount, and the NRS conversion factor for CY 2010. 
We then reduced the rates by 5 percent as required by section 
1895(b)(3)(C) of the Act, as amended by section 3131(b)(1) of the 
Affordable Care Act. For CY 2011 and subsequent calendar years we 
targeted up to 2.5 percent of estimated total payments to be paid as 
outlier payments, and apply a 10-percent agency-level outlier cap.
    In the CY 2017 HH PPS proposed and final rules (81 FR 43737 through 
43742 and 81 FR 76702), we described our concerns regarding patterns 
observed in home health outlier episodes. Specifically, we noted the 
methodology for calculating home health outlier payments may have 
created a financial incentive for providers to increase the number of 
visits during an episode of care in order to surpass the outlier 
threshold; and simultaneously created a disincentive for providers to 
treat medically complex beneficiaries who require fewer but longer 
visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR 
76702), we finalized changes to the methodology used to calculate 
outlier payments, using a cost-per-unit approach rather than a cost-
per-visit approach. This change in methodology allows for more accurate 
payment for outlier episodes, accounting for both the number of visits 
during an episode of care and the length of the visits provided. Using 
this approach, we now convert the national per-visit rates into per 15-
minute unit rates. These per 15-minute unit rates are used to calculate 
the estimated cost of an episode to determine whether the claim will 
receive an outlier payment and the amount of payment for an episode of 
care. In conjunction with our finalized policy to change to a cost-per-
unit approach to estimate episode costs and determine whether an 
outlier episode should receive outlier payments, in the CY 2017 HH PPS 
final rule we also finalized the implementation of a cap on the amount 
of time per day that would be counted toward the estimation of an 
episode's costs for outlier calculation purposes (81 FR 76725). 
Specifically, we limit the amount of time per day (summed across the 
six disciplines of care) to 8 hours (32 units) per day when estimating 
the cost of an episode for outlier calculation purposes.
    In the CY 2017 HH PPS final rule (81 FR 76724), we stated that we 
did not plan to re-estimate the average minutes per visit by discipline 
every year. Additionally, the per unit rates used to estimate an 
episode's cost were updated by the home health update percentage each 
year, meaning we would start with the national per visit amounts for 
the same calendar year when calculating the cost-per-unit used to 
determine the cost of an episode of care (81 FR 76727). We will 
continue to monitor the visit length by discipline as more recent data 
becomes available and may propose to update the rates as needed in the 
future.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56521), 
we finalized a policy to maintain the current methodology for payment 
of high-cost outliers upon implementation of PDGM beginning in CY 2020 
and calculated payment for high-cost outliers based upon 30-day period 
of care. Upon implementation of the PDGM and 30-day unit of payment, we 
finalized the FDL ratio of 0.56 for 30-day periods of care in CY 2020. 
Given that CY 2020 was the first year of the PDGM and the change to a 
30-day unit of payment, we finalized maintaining the same FDL ratio of 
0.56 in CY 2021 as we did not have sufficient CY 2020 data at the time 
of CY 2021 rulemaking to propose a change to the FDL ratio for CY 2021. 
In the CY 2022 HH PPS final rule with comment period (86 FR 62292), we 
estimated that outlier payments would be approximately 1.8 percent of 
total HH PPS final rule payments if we maintained an FDL of 0.56 in CY 
2022. Therefore, in order to pay up to, but no more than, 2.5 percent 
of total payments as outlier payments we finalized an FDL of 0.40 for 
CY 2022. In the CY 2023 HH PPS final rule (87 FR 66875), using CY 2021 
claims utilization data, we finalized an FDL of 0.35 in order to pay up 
to, but no more than, 2.5 percent of the total payment as outlier 
payments in CY 2023. 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) Proposed 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 are proposing an FDL ratio of 
0.38 for CY 2025 which is higher than the finalized CY 2024 FDL of 
0.27. CMS will update the FDL, if needed, in the final rule once we 
have more complete CY 2023 claims data.

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

[[Page 55380]]

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 would 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 (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--
     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, would 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 dNPWT Device
    For CY 2025, we are proposing 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 note that the CPI-U 
for the 12-month period ending in June of 2024 is not available at the 
time of this proposed rulemaking. Therefore, 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 will be updated in 
the final rule.
    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

[[Page 55381]]

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 2023 CMS tested a 
shortened survey across a variety of different types of HHAs. We are 
reviewing the findings of the field test and plan to propose in the 
future updates to the survey with the intent to shorten it.

B. Summary of the Provision of This Proposed Rule

    In this proposed rule, we are proposing to add four new items and 
to modify one assessment item on the OASIS. Second, we propose an 
update to the removal of the suspension of OASIS all-payer data 
collection. Third, we are seeking 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 21 measures for the CY 2024 program 
year, as described in table 39.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TP03JY24.068


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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 proposed rule, we are proposing to add four new items \10\ 
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 
are also proposing to modify one of the current items collected as 
standardized patient assessment data under the SDOH category (the 
Transportation item) as described in section III.D.5. of this proposed 
rule.
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    \10\ 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). 
Section1899B(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: (1) functional status, such as mobility and self-
care at admission to a PAC provider and before discharge from a PAC 
provider; (2) cognitive function, such as ability to express ideas and 
to understand, and mental status, such as depression and dementia; (3) 
special services, treatments, and interventions, such as need for 
ventilator use, dialysis, chemotherapy, central line placement, and 
total parenteral nutrition; (4) medical conditions and comorbidities, 
such as diabetes, congestive heart failure, and pressure ulcers; (5) 
impairments, such as incontinence and an impaired ability to hear, see, 
or swallow, and (6) 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.\11\ 
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.\12\ 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.13 14 15 
This expanded definition aligns our definition of SDOH with the 
definition used by HHS agencies, including OASH, the Centers for 
Disease Control and Prevention (CDC) and the White House Office of 
Science and Technology Policy.16 17 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 (84 FR 
60597 through 60608).\18\ 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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    \11\ 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.
    \12\ World health Organization. Social determinants of health. 
Available at: https://www.who.inte/health-topics/social-determinants-of-health#tab=tab_1.
    \13\ Using Z Codes: The Social Determinants of Health (SDOH). 
Data Journey to Better Outcomes.
    \14\ 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.
    \15\ CMS.gov Measures Management System (MMS). CMS Focus on 
Health Equity. Health Equity Terminology and Quality Measures. 
https://mmshub.cms.gov/about-qulaity-quality-at-CMS/goals/cms-focus-on-health-equity/health-equity-terminology.
    \16\ Centers for Disease Control and Prevention. Social 
Determinants of Health (SDOH) and PLACES Data.
    \17\ ``U.S. Playbook to Address Social Determinants of Health'' 
from the White House Office Of Science And Technology Policy 
(November 2023).
    \18\ 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 are proposing to collect as standardized patient 
assessment data elements under the SDOH category in this proposed rule 
were also identified

[[Page 55384]]

in the 2016 NASEM report \19\ or the 2020 NASEM report \20\ 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 in a position 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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    \19\ Social Determinants of Health. Healthy People 2020. https://www.healthypeople.gov/2020/gopics-objectives/topic/social-determinnats-of-health. February 2019.
    \20\ 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/1017226/25682.
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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.\21\ 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.22 23 Certain HRSNs can lead to unmet social needs 
that directly influence an individual's physical, psychosocial, and 
functional status.\24\ This is particularly true for food security, 
housing stability, utilities security, and access to 
transportation.\25\ Evidence supports the positive impact on health 
outcomes of interventions aimed at addressing HRSNs.\26\
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    \21\ 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.
    \22\ 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.
    \23\ 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.
    \24\ 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/.
    \25\ 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/.
    \26\ 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 are proposing 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 would collect information not already 
captured by the current SDOH items. Specifically, we believe the 
ongoing identification of SDOH would have three significant benefits. 
First, promoting 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 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.\27\ Third, these SDOH items would 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.
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    \27\ 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 would 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.\28\ We note that 
advancing health equity by addressing the health disparities that 
underlie the country's health system is one of our strategic pillars 
\29\ and a Biden-Harris Administration priority.\30\
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    \28\ 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.
    \29\ 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.
    \30\ 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 \31\
---------------------------------------------------------------------------

    \31\ Per the authority for the OASIS assessment instrument under 
1891(d)(1), Home Health Conditions of Participation [42 U.S.C. 
1395bbb].
---------------------------------------------------------------------------

    We are proposing to require 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 
III.D.3.a. of this proposed rule; two items for food, as described in 
section III.D.3.b. of this proposed rule; and one item for utilities, 
as described in section III.D.3.c of this proposed rule.
    We selected the proposed 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.32 33 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-

[[Page 55385]]

partner violence, elder abuse, child maltreatment).\34\
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    \32\ 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.
    \33\ 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-Needsin-Clinical-Settings.pdf.
    \34\ 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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    We believe that requiring HHAs to report new items that are 
currently included in the AHC HRSN Screening Tools would further 
standardize the screening of SDOH across patient assessment instruments 
and the various quality reporting programs. For example, our proposal 
would 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.\35\ Beginning January 2025, IPFs will also be required to 
report whether they have screened patients for the same set of SDOH 
categories.\36\ 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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    \35\ Centers for Medicare & Medicaid Services, FY2023 IPPS/LTCH 
PPS final rule (87 FR 49191 through 49194).
    \36\ 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.37 38 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.\39\ 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.\40\ 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.'' \41\ Rates of chronic 
disease and premature mortality are higher among the unsheltered 
homeless relative to the sheltered.\42\ 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.\43\ Adults (aged 18-64 years) with disabilities experience 
challenges to securing stable housing including affordability and 
accessibility.\44\ 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.\45\ 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 would allow 
patients' additional resources to be allocated towards housing without 
sacrificing other needs.\46\ 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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    \37\ https://health.gov/healthypeople/priority-areas/social-determinants-health.
    \38\ Healthy People 2030 is a long-term, evidence-based effort 
led by the U.S. Department of Health and Human Services (HHS) that 
aims to identify nationwide health improvement priorities and 
improve the health of all Americans.
    \39\ 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
    \40\ 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.
    \41\ 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.
    \42\ 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.
    \43\ 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.
    \44\ 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.
    \45\ U.S. Department of Health & Human Services (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.
    \46\ 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 are proposing 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 47 48 and 
was adapted from the Protocol for Responding to and Assessing Patients' 
Assets, Risks, and Experiences (PRAPARE) tool.\49\ 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://

[[Page 55386]]

www.cms.gov/medicare/quality/home-health/home-health-quality-measures.
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    \47\ More information about the AHC HRSN Screening Tool is 
available on the website at https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf.
    \48\ 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.
    \49\ 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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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.\50\ 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.\51\ 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.'' \52\ While having enough food is one 
of many predictors for health outcomes, a diet low in nutritious foods 
is also a factor.\53\ 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.\54\ 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.\55\ 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,\56\ 
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.\57\
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    \50\ 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/.
    \51\ Hernandez, D. C., Reesor, L. M., & Murillo, R. (2017). Food 
insecurity and adult overweight/obesity: Gender and race/ethnic 
disparities. Appetite, 117, 373-378.
    \52\ Food and Nutrition Security (n.d.). USDA. https://www.usda.gov/nutrition-security.
    \53\ 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.
    \54\ 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.
    \55\ 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.
    \56\ Administration for Community Living. Nutrition Services. 
Last updated 02/02/2024. Accessed 04/19/2024. https://acl.gov/programs/health-wellness/nutrition-services.
    \57\ 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 are proposing 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).\58\ The first proposed 
Food item states, ``Within the past 12 months, you worried that your 
food would 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.
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    \58\ 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/.
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c. Utilities
    A lack of energy (utility) security can be defined as an inability 
to adequately meet basic household energy needs.\59\ According to the 
Department of Energy, one in three households in the U.S. are unable to 
adequately meet basic household energy needs.\60\ The median energy 
burden for rural households of older adults is considerably higher than 
that for households without older adults.\61\ 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.\62\ 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.\63\ 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.\64\ The effects of a lack of 
utility security include vulnerability to environmental exposures such 
as dampness, mold, and thermal discomfort in the home, which

[[Page 55387]]

have direct effect on patients' health.\65\ 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.\66\ We 
believe adopting an item to collect information about a patient's 
utility security upon start or resumption of care in HHAs would 
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) \67\ or receive broadband 
internet service through the Affordable Connectivity Program.\68\ 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.\69\
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    \59\ 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.
    \60\ 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/.
    \61\ 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.
    \62\ 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.
    \63\ 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.
    \64\ 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/.
    \65\ 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.
    \66\ 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.
    \67\ Low Income Home Energy Assistance Program (LIHEAP) [verbar] 
The Administration for Children and Families (hhs.gov) (https://www.acf.hhs.gov/ocs/programs/liheap).
    \68\ https://www.fcc.gov/broadbandbenefit.
    \69\ 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.
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    We are proposing to adopt a new item, Utilities, 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.\70\ 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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    \70\ 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 
proposed 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 this proposal.
    We invite 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.
5. Proposal To Modify 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 would 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 are proposing to 
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. A1250. Transportation currently 
collected in the OASIS asks, ``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. 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 are proposing 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 the distinction 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 
are proposing 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

[[Page 55388]]

ways, including accessing goods and services, obtaining adequate food 
and clothing, and social activities.\71\ The proposed modified 
Transportation item would 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.
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    \71\ Victoria Transport Policy Institute (2016, August 25). 
Basic access and basic mobility: Meeting society's most important 
transportation needs. Retrieved from http://www.vtpi.org/tdm/tdm103.htm.
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    For the reasons stated, we are proposing to modify 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 invite comment on this 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 would 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 would start but did 
not address the other data collection time points.
    To clarify expectations around the start of OASIS all-payer data 
collection we are proposing 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 agency demographics (for example, 
Agency's CMS Certification Number (CCN), State and Branch ID#s) and 
patient demographics (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 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 would ensure that baseline data is available for use in 
calculating or risk-adjusting quality measures, and in linking to prior 
OASIS assessments. The data would 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.\72\ The CY 2023 HH PPS final rule ends 
this temporary suspension of OASIS data collection for non-Medicare/
non-Medicaid patients.
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    \72\ E:\PUBLAW\PUBL173.108 (congress.gov).
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    CMS is providing a voluntary phase-in period for HHAs to begin 
OASIS data collection and submission for all non-Medicare/non-Medicaid 
patients.
     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 invite comment on this proposal to update requirements for OASIS 
all-payer data collection beginning January 1, 2025.

[[Page 55389]]

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 proposed rule, we are 
proposing 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 proposed rule beginning January 1, 2027, with 
the CY 2027 HH QRP.
    We are proposing that HHAs would 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 would 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 are also proposing that HHAs that submit the living situation, 
food, utilities, and transportation items with respect to start or 
resumption of care would 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 proposed 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 invite 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 
proposed rule; two Food items, as described in section III.D.3.b of 
this proposed rule; one Utilities item as described in section 
III.D.3.c of this proposed rule; and one Transportation item as 
described in section III.D.5 of this proposed rule.

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

    We are seeking 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) on a set of principles for selecting and prioritizing HH QRP 
measures, identifying measurement gaps, and suitable measures for 
filling these gaps. Within this proposed 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.\73\ The 
TEP discussed the alignment of PAC and Hospice measures with CMS' 
``Universal Foundation'' of quality measures.\74\ 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.
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    \73\ 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.
    \74\ 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.
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    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,\75\ which could 
represent overall immunization status of patients such as the Adult 
Immunization Status measure \76\ in the Universal Foundation. A second 
concept on which we are seeking feedback is the concept of depression 
for the HH QRP, similar to the Clinical Screening for Depression and 
Follow-up measure \77\ in the Universal Foundation. Third, we are 
seeking 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 \78\ included in the Universal Foundation of Quality Measures.
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    \75\ 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.
    \76\ CMS Measures Inventory Tool. Adult immunization status 
measure found at https://cmit.cms.gov/cmit/#/FamilyView?familyId=26.
    \77\ 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.
    \78\ Initiation and Engagement of Substance Use Disorder 
Treatment measure found at https://ecqi.healthit.gov/ecqm/ec/2023/cms0137v11.
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    While we will not be responding to specific comments in response to 
this RFI in the CY 2025 HH PPS final rule, we invite public comment on 
these four measure concepts and intend to use this input to inform our 
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

[[Page 55390]]

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.\79\ The evaluation of the original Model also found reductions 
in unplanned acute care hospitalizations and skilled nursing facility 
(SNF) stays, resulting in reductions in inpatient and SNF spending. The 
U.S. Secretary of Health and Human Services determined that expansion 
of the original HHVBP Model would further reduce Medicare spending and 
improve the quality of care. In October 2020, the CMS Chief Actuary 
certified that expansion of the HHVBP Model would produce Medicare 
savings if expanded to all States.\80\
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    \79\ https://innovation.cms.gov/data-and-reports/2020/hhvbp-thirdann-rpt.
    \80\ https://www.cms.gov/files/document/certificationhome-health-value-based-purchasing-hhvbpmodel.pdf.
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    On January 8, 2021, CMS announced the certification of the HHVBP 
Model for expansion nationwide, as well as the intent to expand the 
Model through notice and comment rulemaking.\81\
---------------------------------------------------------------------------

    \81\ https://www.cms.gov/newsroom/press-releases/cms-takes-action-improve-home-health-care-seniors-announces-intent-expand-home-health-value-based.
---------------------------------------------------------------------------

    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.\82\ The recommended objectives emphasize measuring patient 
outcomes and functional status; appropriateness of care; and incentives 
for providers to build infrastructure to 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:
---------------------------------------------------------------------------

    \82\ 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.\83\ Creating one or more 
measures based on an HHA's ability to meet caregiver needs would permit 
measurement of changes in caregiver quality-of-life.
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    \83\ 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 injury (claims-based): Several TEP members 
suggested that CMS explore a claims-based measure of falls with 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.\84\ 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 would only be available for Fee for Service patients. 
Due to the high rate of non-reporting, the OASIS-based falls measure 
may not

[[Page 55391]]

provide accurate information about the incidence of these falls.
---------------------------------------------------------------------------

    \84\ https://oig.hhs.gov/oei/reports/OEI-05-22-00290.asp.
---------------------------------------------------------------------------

     Medicare spending per Beneficiary: 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 would 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 request comments related to adding the potential performance 
measures described previously to the HHVBP Measure Set. We also request 
comments about other potential performance measures that we should 
consider for the expanded HHVBP Model.

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

    In alignment with the President's Executive orders \85\ 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.\86\
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    \85\ 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.''
    \86\ 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).\87\ 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, would 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.
---------------------------------------------------------------------------

    \87\ 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.\88\ Previous studies have found that patients from 
underserved communities have higher rates of hospital readmissions, are 
more likely to be discharged without functional improvement,\89\ 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.
---------------------------------------------------------------------------

    \88\ 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.
    \89\ 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.\90\ 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.\91\ Another study found 
that

[[Page 55392]]

differences both within and across HHAs contribute to the overall 
disparities in patients' functional improvement.\92\ 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.\93\ 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.\94\
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    \90\ 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.
    \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.
    \93\ 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.
    \94\ 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 would its impact on underserved communities be?
     Feasibility: How long would it take to implement the 
approach? Are the necessary data currently being collected? How many 
HHAs would 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 the CY 2024 SNF 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 Dual Eligible Status (DES) 
proportion and the LIS eligibility proportion is above 0.98. have not 
yet examined low-income subsidy (LIS) eligibility. 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 would 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 reg text at Sec.  
413.338(a) would 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 would alter the effects of the HEA. We are 
also examining measures of the underserved population that are based on 
the percentage of

[[Page 55393]]

patients with Medicaid as the only payment source.

F. Other Health Equity Measures

    We are also exploring other health equity measures that would 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.

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.\95\ 
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.
---------------------------------------------------------------------------

    \95\ 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 (Pu Law 108-173) amended section 1861 of the 
Act to provide Medicare Part B coverage of the IVIG product for the 
treatment of PIDD in the home, but not the items and services involved 
with administration.
    Section 101 of the Medicare IVIG Access and Strengthening Medicare 
and Repaying Taxpayers Act of 2012 (Medicare IVIG Access Act) (Pub. L. 
112-242) mandated the establishment, implementation, and evaluation of 
a 3-year Medicare Intravenous Immune Globulin (IVIG) Demonstration 
Project (the Demonstration) under Part B of title XVIII of the Act. The 
Demonstration was implemented to evaluate the benefits of providing 
coverage and payment for items and services needed for the home 
administration of IVIG for the treatment of PIDD, and to determine if 
it would improve access to home IVIG therapy for patients with PIDD. 
The Medicare IVIG Access Act mandated that Medicare would establish a 
per visit payment amount for the items and services necessary for the 
home administration of IVIG therapy for beneficiaries with specific 
PIDD diagnoses. The Demonstration did not include Medicare payment for 
the IVIG product which continues to be paid under Part B in accordance 
with 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.\96\
---------------------------------------------------------------------------

    \96\ 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 Public Law 115-63 extended the

[[Page 55394]]

Demonstration through December 31, 2020.
    Division CC, section 104, of the Consolidated Appropriations Act, 
2021 (CAA, 2021) (Pub. L. 116-260), further extended the Demonstration 
for another 3 years through December 31, 2023.
    Division FF, section 4134 of the CAA, 2023 (CAA, 2023) (Pub. L. 
117-328) mandated that CMS establish permanent coverage and payment for 
items and services related to administration of IVIG in a patient's 
home of a patient with PIDD. The permanent home IVIG items and services 
payment is effective for home IVIG administration furnished on or after 
January 1, 2024. Payment for these items and services is required to be 
a separate bundled payment made to a supplier for all administration 
items and services furnished in the home during a calendar day. The 
statute provides that payment amount may be based on the amount 
established under the Demonstration. The standard Part B coinsurance 
and the Part B deductible is required to apply. In addition, that 
statute states that the separate bundled 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 set out the medical and other health services requirements 
under Part B. The regulations at Sec.  410.10 identify the services 
that are subject to the conditions and limitations specified in this 
subpart. Section 410.10(y) includes intravenous immune globulin 
administered in the home for the treatment of primary immune deficiency 
diseases. Section 410.12 outlines general basic conditions and 
limitations for coverage of medical and other health services under 
Part B, as identified in 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) \97\ and IVIG Policy

[[Page 55395]]

Article (A52509) \98\) provide direction on coding and coverage for the 
IVIG product at home. Through the Local Coverage Determination (LCD) 
for Intravenous Immune Globulin (L33610),\99\ 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 \100\ 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 40.
---------------------------------------------------------------------------

    \97\ https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33610.
    \98\ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52509.
    \99\ Local Coverage Determination (LCD): IVIG (L33610) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33610&ContrId=389.
    \100\ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52509.
[GRAPHIC] [TIFF OMITTED] TP03JY24.069

    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 40 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 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 sub-regulatory 
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

[[Page 55396]]

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.\101\ 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 would 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 would 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.\102\ 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.
---------------------------------------------------------------------------

    \101\ 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.
    \102\ 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, would 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),\103\ 
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 and the HIT services benefits on the same date of 
service. We also recognize that a beneficiary may, on occasion, switch 
from receiving immunoglobulin subcutaneously to intravenously and vice 
versa, and as such, utilize both the HIT services and the IVIG benefits 
within the same month.
---------------------------------------------------------------------------

    \103\ 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

[[Page 55397]]

1834(j)(5) of the Act, which are a requirement for supplier of medical 
equipment and supplies, by adding a new subparagraph (E), clarifying 
with respect to payment, that items and services related to the 
administration of intravenous immune globulin furnished on or after 
January 1, 2024, as described in section 1861(zz) of the Act, are 
included in the definition of medical equipment and supplies. This 
means that suppliers that furnish IVIG administration items and 
services must meet the existing DMEPOS supplier requirement for payment 
purposes under this benefit. Suppliers of IVIG administration items and 
services must enroll as a DMEPOS supplier and comply with the Medicare 
program's DMEPOS supplier standards (found at 42 CFR 424.57(c)) and 
DMEPOS quality standards to become accredited for furnishing medical 
equipment and supplies. Further, 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 proposed 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' ''.\104\ 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).
---------------------------------------------------------------------------

    \104\ 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. Proposed 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 would 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 would 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 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 would 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

[[Page 55398]]

the home health payment rate update percentage for such year. 
Therefore, the proposed 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).
    The updated home intravenous immune globulin 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) once this rate is finalized. 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' established methodology via the Home Health 
Prospective Payment System Rate Update Change Request and posted on the 
CMS HIT/Home IVIG Services web page.\105\ 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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    \105\ https://www.cms.gov/medicare/payment/fee-for-service-providers/home-infusion-therapy.
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VI. Home Health CoP Changes and Long Term (LTC) Requirements for Acute 
Respiratory Illness Reporting

A. Home Health 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. Proposed 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 requirements of Sec.  484.60. 
This CoP states that patients are accepted for treatment on the 
reasonable expectation that an HHA can meet the patient's needs in his 
or her place of residence. 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.
    Researchers have found that timely admission to home health, and in 
turn the initiation of services are key to good home health patient 
outcomes. Timely initiation of home health care lowers the risk of 30-
day hospital readmissions.\107\ According to one study published in 
2021, when the initiation of home health services is significantly 
delayed (that is, from 8 to14 days after discharge), the odds of 
rehospitalization for diabetic patients were four times greater than 
among patients receiving home health service initiation within 2 
days.\106\ Yet the rate of timely initiation of home health care varies 
significantly, indicating that the referral and acceptance process is 
in need of improvement. In a study of initiation of home health care 
for individuals diagnosed with Alzheimer's disease and related 
dementia,\107\ only 57.3 percent of patients discharged from the 
hospital began home health services within 48 hours of discharge, while 
21.6 percent of patients had care initiated between 3 and 7 days post-
discharge, another 8.4 percent had care initiated between 8-10 days 
post-discharge, and 12.8 percent experienced a delay of 11 to 14 days 
between discharge and home health care initiation. The 42.7 percent of 
patients in the study who waited 3 or more days after discharge for 
initiation of home health services were more likely to be dually 
enrolled in Medicare and Medicaid, live in rural areas, have 
experienced longer hospital stays, experienced a hospital acquired 
condition, or experienced an intensive care unit stay. Additionally, 
this population was more likely to have been discharged with a lower 
functional status and were more likely to live alone. In another study 
of Medicare beneficiaries,\108\ only 54 percent of patients discharged 
from the hospital to home health care received home health care 
services within 14 days of discharge. The rate of patients receiving 
home health services within 14 days of discharge with a home health 
referral was even lower among Black and Hispanic patients, those who 
were dually enrolled in both Medicare and Medicaid, and patients who 
lived in high-poverty, high unemployment zip codes. This research 
brings attention to vulnerable populations at risk of poor outcomes 
associated with delays in the timely initiation of home health care 
services.\109\
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    \106\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8197411/, 
date accessed 5-7-24.
    \107\ Amol M. Karmarkar, Indrakshi Roy, Taylor Lane, Stefany 
Shaibi, Julie A. Baldwin & Amit Kumar (2023), Home health services 
for minorities in urban and rural areas with Alzheimer's and related 
dementia, Home Health Care Services Quarterly, 42:4, 265-281, DOI: 
10.1080/01621424.2023.2206368.
    \108\ Assessment of Receipt of the First Home Health Care Visit 
After Hospital Discharge Among Older Adults. Jun Li, Ph.D., Mingyu 
Qi, MS, and Rachel M. Werner, Ph.D., MD. JAMA Netw Open. 2020 Sep; 
3(9): e2015470. doi: 10.1001/jamanetworkopen.2020.15470:10.1001/
jamanetworkopen.2020.15470.
    \109\ https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.13139, date accessed 5-08-24.
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    Timely initiation of home health care services is also 
intrinsically linked to the home health referral process, whereby 
connections are made between referral sources and HHAs. Patient 
referral sources are varied, with some patients and caregivers 
conducting their own searches for care, known as self-referrals, while 
others are referred by a community-based practitioner or an acute care 
provider such as a hospital. Patients that begin HHA care without an

[[Page 55399]]

immediate prior hospitalization, those who are self-referrals or 
referred by a community-based practitioner, tend to be Medicaid 
recipients, have cognitive impairments, and are more socially 
vulnerable (defined as the gap between patient needs and the patient's 
available resources) 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 HHA 
services.\110\ This population has unique needs and circumstances needs 
that may make finding the right HHA a challenging process, and they may 
not have access to information needed to target their search for an HHA 
in an effective and efficient manner. Given the significant delays in 
home health care initiation described earlier and the role that this 
information plays in facilitating care initiation, we are concerned 
about this lack of public transparency and whether referral sources, 
including patients and caregivers searching for HHA services, currently 
have access to sufficient and timely information necessary to locate an 
HHA that is capable of meeting each specific patient's needs. Without 
such information, care delays are likely to occur, placing patients at 
higher risk of poor outcomes.
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    \110\ 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.
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    In addition to the challenges of finding the right HHA and 
resultant potential delays in the timely initiation of home health 
care, we are also concerned that HHAs are at higher risk of 
overextending their available resources when accepting new patients to 
HHA services. Delays in service initiation may indicate not only that 
referral sources have difficulty locating an appropriate HHA, but also 
that HHAs are accepting patients when and for whom they are not capable 
of delivering timely care. We are aware of anecdotal reports of home 
care agencies not providing care to meet patient needs 
111 112 and reports by agencies of challenges maintaining 
appropriate staff caseloads to continue delivering care to patients 
that have been accepted for service. We acknowledge that these 
challenges may be related to workforce shortages. HHAs are expected to 
discharge patients for whom the HHA is unable to deliver care to meet 
patient needs, and to adhere to the HHA discharge requirements at Sec.  
484.58. Such discharges create transition of care burdens for patients 
and their caregivers that may be prevented by consistently applying an 
admission to service policy that includes the elements proposed in this 
rule to ensure the correct match of an HHA's available patient care 
resources and the anticipated needs of the patients accepted for 
service by that HHA. In line with this HHA proposal, CMS recently 
published a final rule titled ``Ensuring Access to Medicaid Services'' 
(89 FR 40542, May 10, 2024), which requires States to report how they 
establish and maintain Home and Community Based Services (HCBS) wait 
lists, assess wait times, and report on quality measures. That final 
rule aims to increase transparency and accountability and standardize 
data and monitoring, with the goal of improving access to care.
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    \111\ Pandemic-Fueled Shortages of Home Health Workers Strand 
Patients Without Necessary Care, February 3, 2022, KFF Health News. 
https://kffhealthnews.org/news/article/pandemic-fueled-home-health-care-shortages-strand-patients/. Accessed March 12, 2024.
    \112\ Caregiver Needed: How the Nation's Workforce Shortages 
Make it Harder to Age Well at Home, September 2022, USAging. https://www.usaging.org/Files/Workforce-Issues_508.pdf. Accessed March 14, 
2024.
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    To address these dual concerns regarding the referral and 
acceptance process and their implications for prospective and current 
patients, we propose 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 propose 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. It is our understanding, based on information provided by 
HHA accrediting organizations and the largest HHA trade association, 
that HHAs typically have acceptance to service policies that are 
categorical in nature, meaning that the policies address entire 
categories of diagnosis or service types that they are or are not 
capable of providing care for. This proposed rule would not prevent 
HHAs from maintaining these existing policies and is intended to 
complement them. We also understand that an HHA's case load, case mix, 
and staffing levels may change over time, and that an HHA may choose to 
pre-establish methodologies that take into account such fluctuations as 
part of their acceptance to service policy to ensure consistency and 
minimize administrative efforts in maintaining the policy.
    We propose, at Sec.  484.105(i)(1)(i) through (iv), that HHAs would 
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 proposed 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 would 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. In accordance with Sec.  
484.60, HHAs may only accept those patients for whom there is a 
reasonable expectation that the HHA will be able to meet the patient's 
needs.
    We therefore propose 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. Not only would consistent application of the 
acceptance to service policy help to ensure that HHAs only accept 
referrals for care that they can deliver, it would also ensure that 
HHAs apply their acceptance policy based on clinical and operational 
factors (those criteria included in proposed Sec.  484.105(i)(1)(ii) 
through (iv)) that impact patient health and safety. While Medicare-
participating HHAs may choose to accept other, non-Medicare sources of 
payment, we expect that HHAs would apply their acceptance to service 
policy consistently in a manner that is neutral to the source(s) of 
payment for a referral. That is, if an HHA accepts payment from both 
Medicare and another payment source, ``source X,'' the HHA's referral 
policy should be applied consistently to referrals for patients having 
Medicare or ``source X'' as a payment source. It is our position that 
HHAs should accept or decline patient referrals based solely on 
clinical considerations and the capacity of the HHA to safely and 
effectively deliver care to meet patient needs,

[[Page 55400]]

rather than on financial factors related to the perceived adequacy of 
the payment rate that the HHA has already voluntarily agreed to accept 
upon establishment of relationships with its payment sources.
    We also propose, at Sec.  484.105(i)(2), that HHAs make public 
accurate information regarding the services offered by the HHA and any 
limitations related to the types of specialty services, service 
duration, or service frequency, and that HHAs review that information 
annually or as necessary. As previously discussed, HHAs have the 
flexibility to choose the services that they provide and the geographic 
areas that they serve. As such, each HHA may provide a different mix of 
services or offer different specialty services. Likewise, each HHA has 
different geographical boundaries for its service area. Knowing which 
areas are served by an HHA and which services an HHA does and does not 
provide would assist referral sources and self-referrals alike in 
identifying HHAs that provide the services needed by the patient. 
Likewise, each HHA has unique staffing levels and staffing competencies 
affecting its capacity to deliver patient care, and those may change 
over time. To the extent that these variations in staffing impact the 
capacity of an HHA to provide its typically offered services, we would 
require that HHAs make public such limitations on specialty services, 
service duration, and service frequency to further inform the search 
efforts of all referral sources.
    In short, making information regarding the services offered by the 
HHA and any limitations related to the types of specialty services, 
service duration, or service frequency available to the public, such as 
sharing it on the HHA's website and providing the same information upon 
request for those without access to the website, would facilitate the 
search for an HHA to meet a patient's needs, both from clinical 
referral sources such as hospitals and physician offices, and from 
patients and caregivers directly seeking care. The goal of this 
proposal is to reduce the delay between the time when a patient is 
identified as needing home health care and the time when the patient 
begins receiving such care 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 30-day rehospitalizations and may place vulnerable 
populations at risk for various other adverse outcomes.
    We request public comment on these proposals. Specifically, we 
request 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 request public comment regarding other ways to improve 
the referral process for referral sources, patients, and HHAs.
3. Requests for Information
a. RFI Regarding Rehabilitative Therapists Conducting the Initial and 
Comprehensive Assessment
    The current CoPs at Sec.  484.55(a)(1) require the registered nurse 
to conduct an initial assessment visit to determine the immediate care 
and support needs of the patient within 48 hours of referral, within 48 
hours of the patient's return home, or on the physician allowed 
practitioner-ordered start of care date. The initial assessment 
establishes a patient's eligibility for coverage under the Medicare 
home health benefit. The clinician conducting the initial visit should 
determine the patient's homebound status, primary physician, and 
skilled services required. Section 484.55(b) further requires that the 
comprehensive assessment must be completed in a timely manner by a 
registered nurse, but no later than 5 calendar days after the start of 
care. However, when therapy services are the sole services ordered by 
the physician or allowed practitioner, the initial and comprehensive 
assessments can be conducted by rehabilitation professionals 
(specifically occupational therapists (OT), physical therapists (PT), 
or speech-language pathologists (SLP)), subject to certain limitations, 
as specified by Sec.  484.55(a)(2) and (b)(3).
    Section 484.55(c) establishes the minimum content of the 
comprehensive assessment, which must accurately reflect the patient's 
status and include the patient's current health, psychosocial, 
functional, and cognitive status. The comprehensive assessment must 
also reflect the patient's strengths, goals, and care preferences, 
including information that may be used to demonstrate the patient's 
progress towards the achievement of the goals identified by the patient 
and the measurable outcomes identified by the HHA. Additionally, the 
comprehensive assessment must include a determination of the patient's 
continuing need for home care, and their medical, nursing, 
rehabilitative, social, and discharge planning needs. Further, the 
comprehensive assessment must also include a review of the patient's 
medication and identify the patient's primary caregiver(s) or patient 
representative. Lastly, the comprehensive assessment must incorporate 
the current version of the Outcome and Assessment Information Set 
(OASIS) items. HHAs must complete data collection for the comprehensive 
assessment within 5 days of the start of care.
    At the beginning of the COVID-19 Public Health Emergency (PHE), CMS 
waived the requirements at Sec.  484.55(a)(2) and (b)(3) and thus 
permitted rehabilitation professionals to perform the initial and 
comprehensive assessment in instances when both nursing and therapy 
services are ordered. This temporary blanket waiver reflected the 
unique circumstances of the PHE, with its acute pressures on the 
nursing workforce, and allowed rehabilitation professionals to perform 
the initial and comprehensive assessment for patients receiving therapy 
services as part of the broader nursing and therapy care plan, to the 
extent permitted under State law, regardless of whether the therapy 
service established patient eligibility to receive home care.
    Subsequently, Division CC, section 115 of the Consolidated 
Appropriations Act (CAA) of 2021 (Pub. L. 116-260), permitted OTs to 
conduct the initial and comprehensive assessments only when OT is on 
the home health plan of care with either PT or speech therapy, and 
skilled nursing services are not initially on the plan of care. CMS 
proposed changes to Sec.  484.55(a)(3) and (b)(2) in the CY 2022 Home 
Health PPS proposed rule (86 FR 35874), and finalized the changes in 
the CY 2022 Home Health PPS final rule (86 FR 62240).
    However, some groups continue to advocate for CMS to permanently 
allow therapists to perform the initial and comprehensive assessment in 
the home health setting when both therapy and nursing services are 
ordered. While CMS received limited feedback during the CY 2022 Home 
Health PPS proposed rule from several commenters supporting a change of 
this type, we are interested in obtaining additional feedback on this 
specific potential change.
    The three types of rehabilitative therapists (OT, PT, and SLP) have 
different education requirements for entry into to practice. Currently, 
entry-level education for OT is either a Master's degree or Doctorate 
of Occupational Therapy. Education programs are accredited by the 
Accreditation Council for Occupational

[[Page 55401]]

Therapy Education (ACOTE) of the American Occupational Therapy 
Association (AOTA). The ACOTE establishes, approves, and administers 
educational standards to evaluate occupational therapy educational 
programs. Graduates of ACOTE-accredited programs are eligible to take 
the National Board for Certification in Occupational Therapy (NBCOT) 
certification exam and apply for State licensure.
    Physical therapy entry-level education requires a Doctor of 
Physical Therapy degree. The Commission on Accreditation in Physical 
Therapy Education (CAPTE) of American Physical Therapy Association 
(APTA) accredits entry-level physical therapist education programs. 
Graduates of these programs are then eligible to take the National 
Physical Therapy Examination and apply for State licensure.
    Speech Language Pathologists must obtain a Certificate of Clinical 
Competence in Speech-Language Pathology (CCC-SLP) as well as state 
licensure. This requires graduation from a program accredited by the 
Council on Academic Accreditation in Audiology and Speech-Language 
Pathology (CAA) of the American Speech-Language-Hearing Association 
(ASHA). Individuals applying for certification in speech-language 
pathology must have been awarded a master's, doctoral, or other 
recognized post-baccalaureate degree. Once students complete all 
academic coursework and a graduate student clinical practicum, they 
must also complete a clinical fellowship under the supervision of a SLP 
mentor. The clinical fellowship requires working at least 36 weeks and 
1,260 hours and is intended to transition the fellow from a student 
enrolled in a communication sciences and disorders (CSD) program to an 
independent provider of speech-language pathology clinical services.
    The APTA has indicated that the accreditation standards for entry-
level certification programs for physical therapy have evolved over 
time, with major changes occurring between 1996 and 2024, and that 
contemporary PT education programs are now required to include content 
for students on broader health care issues to promote team-based and 
interdisciplinary practice. The association states that the current 
criteria reflect that PT education has shifted significantly since the 
initial and comprehensive assessments were codified into the home 
health CoPs, preparing any PT to perform these assessments safely. APTA 
further contends that education standards have shifted from an initial 
focus on physical sciences to expressly incorporate interdisciplinary 
care topics, including pharmacology and psychosocial, and clinical 
educational experience in practice settings common to PTs (for example, 
HHAs, skilled nursing facilities (SNFs), and inpatient rehabilitation 
facility (IRFs)). The curricular requirements include the general 
clinical skills required to conduct the initial and comprehensive 
assessments, both in the identification of immediate care and support 
needs, as well as the assessment of the patient's general health, 
psychosocial, functional, cognitive, and pharmacological status.
    Given recent input from stakeholders, including therapy 
professional organizations, we seek public comments regarding whether 
CMS should shift its longstanding policy and permit all classes of 
rehabilitative therapists (PTs, SLPs, and OTs) to conduct the initial 
assessment and comprehensive assessment for cases that have both 
therapy and nursing services ordered as part of the plan of care. We 
ask the public for data, detailed analysis, academic studies, or any 
other information to support their comments that provide a direct link 
to patient health and safety. Specifically, we solicit comment 
regarding the following:
     What types of mentorships, preceptorship, or training do 
these disciplines have qualifying them to conduct the initial 
assessment and comprehensive assessment?
     How do HHAs currently assign staff to conduct the initial 
assessment and comprehensive assessment? Do HHAs implement specific 
skill and competency requirements?
     Do the education requirements for entry-level 
rehabilitative therapist provide them with the skills to perform both 
the initial assessment and comprehensive assessment? Is this consistent 
across all the therapy disciplines? How does this compare with entry-
level education for nursing staff?
     What, if any, potential education or skills gaps may exist 
for rehabilitative therapists in conducting the initial assessment and 
comprehensive assessment?
     What challenges did HHAs and therapists that conducted 
these assessments under the PHE waiver experience that may have 
impacted the quality of these assessments?
     For the HHAs and therapists that conducted the initial 
assessment and comprehensive assessment under the PHE waiver, what were 
the benefits and were there any unintended consequences of this on 
patient health and safety?
     What challenges, barriers, or other factors, such as 
workforce shortages, particularly in rural areas, impact rehabilitative 
therapists and nurses in meeting the needs of patients at the start of 
care and early in the plan of care?
b. Plan of Care Development and Scope of Services Home Health Patients 
Receive
    In an effort to improve the HHA referral process, ensure the timely 
delivery of home health care, and ensure that home health care is 
delivered in a manner that meets patient needs and achieves the 
measurable outcomes and goals set forth in each patient's 
individualized plan of care, we are requesting public comment on 
policies related to these goals. Anecdotally, CMS has received an 
increasing number of beneficiary complaints related to the difficulty 
of finding a HHA to accept them for service. Beneficiaries complain 
that in some instances, HHA services are being altered or diminished 
from the original plan of care without an accompanying reduction in 
patient needs or achievement of the measurable outcomes and goals set 
forth in the plan of care. We seek to better understand these issues to 
inform future policy decisions, consistent with our statutory authority 
to ensure the health and safety of home health patients.
    In CY 2022 Home Health PPS proposed rule, we solicited comments 
seeking information about the adequacy of aide staffing (86 FR 35874, 
July 7, 2021). However, only a few commenters provided information 
specific to the questions we posed in our request. This information was 
not sufficient to gain insight to the factors that may be impacting the 
decline in aide services. No further development action was taken due 
to the lack of substantive data and response from stakeholders.
    The number of referrals to HHAs continue to increase. Patient 
acuity is also increasing 113 114 with the evolving practice 
of direct discharge of intensive care unit (ICU) patients, a practice 
borne out of resource constrained health care infrastructure.\115\ 
Compared to 2019 averages, patients are 6 percent more acute at 
discharge. Patients with higher acuity typically have more complex care 
needs and a higher risk of

[[Page 55402]]

complications.116 117 The overall aging of the U.S. 
population contributes to overall higher patient acuity. The U.S. 
Census Bureau estimated that by 2023 73 million baby boomers in the 
U.S. will be 65 or older. Chronic conditions are more common in older 
adults and can contribute to higher acuity.118 119 In 
addition, procedures that were once traditionally done in hospitals are 
migrating to the outpatient setting and patients are being discharged 
on the same day as the procedure. Specifically, surgical procedures 
within the U.S. are increasingly shifting to outpatient or non-hospital 
locations, as seen in the expected 4 percent annual expansion rate of 
the ambulatory surgery center (ASC) market over the 10-year period from 
2017 to 2027.\120\ For example, the incidence of total knee 
arthroplasty (TKA) surgery performed in the outpatient setting has 
increased as a result of improved perioperative recovery protocols and 
challenges brought by the COVID-19 pandemic on health systems.\121\ 
Further, literature shows that factors like the pandemic and ``acuity 
creep'' have resulted in HHAs accepting for service much more 
complicated patients. ``As the demand for home-based care continues to 
rise, so does the need for more intensive care plans as patients 
continue to be sicker and more complex.'' \122\
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    \113\ The evolution of care: An annual care delivery report, 
from CarePort, powered by WellSky, 2023.
    \114\ https://www.fiercehealthcare.com/providers/hospitals-
struggling-discharge-patients-post-acute-care-settings-wellsky-
report#:~:text=Patients%20in%20the%20hospital%20are,post%2Dacute%20se
ttings%20more%20difficult.
    \115\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9750104/.
    \116\ The evolution of care: An annual care delivery report, 
from CarePort, powered by WellSky, 2023.
    \117\ https://www.fiercehealthcare.com/providers/hospitals-
struggling-discharge-patients-post-acute-care-settings-wellsky-
report#:~:text=Patients%20in%20the%20hospital%20are,post%2Dacute%20se
ttings%20more%20difficult.
    \118\ https://www.fiercehealthcare.com/providers/hospitals-
struggling-discharge-patients-post-acute-care-settings-wellsky-
report#:~:text=Patients%20in%20the%20hospital%20are,post%2Dacute%20se
ttings%20more%20difficult.
    \119\ https://www.census.gov/library/stories/2019/12/by-2030-all-baby-boomers-will-be-age-65-or-older.html.
    \120\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10562071/
#:~:text=Surgical%20procedures%20within%20the%20United,In%202018%2C%2
0Young%20et%20al.
    \121\ https://josr-online.biomedcentral.com/articles/10.1186/s13018-023-03750-4.
    \122\ https://homehealthcarenews.com/2024/01/home-health-agencies-grapple-with-acuity-creep-as-patient-needs-become-more-complex/.
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    We acknowledge that there may be additional factors, such as the 
shortage of health care practitioners (nurses and aides) across various 
health care sectors, and HHA business operations and practices that 
also influence an HHA's care planning and delivery of services. We seek 
to understand the changes in practice that have occurred since 
publication of the January 13, 2017 ``Medicare and Medicaid Program: 
Conditions of Participation for Home Health Agencies'' final rule that 
revised the home health agency CoPs (82 FR 4504) and review any 
potential CoP revisions that should be considered. In order to protect 
the health and safety of all HHA patients, we seek to understand how 
the services offered and business operations of the HHA may influence 
the development and implementation of care plans. We are also seeking 
additional information on how HHAs communicate with patients' ordering 
physicians and allowed practitioners regarding the frequency and 
duration of services.
    We are seeking public comments on factors that influence the 
services HHAs provide, the referral process, limitations on patients 
being able to obtain HHA service, such as rural location and 
availability of staff, plan of care development, and the HHA's 
communication with patients' ordering physicians and allowed 
practitioners. We ask the public for data, detailed analysis, academic 
studies, or any other information to support their comments that 
provide a direct link to patient health and safety. Specifically, we 
solicit comment regarding the following questions:
     What factors influence an HHA's decision on what services 
to offer as part of its business model and how often do HHAs change the 
service mix?
     What are the common reasons for an HHA to not accept a 
referral?
     How do physicians and allowed practitioners use their role 
in establishing and reviewing the plan of care to ensure patients are 
receiving the right mix, duration, and frequency of services to meet 
the measurable outcomes and goals identified by the HHA and the 
patient?
     To what extent do physicians rely on HHA clinician 
evaluations and reports in establishing the mix of services, service 
frequency, and service duration included in the plan of care?
     What are the patient and caregiver experiences in 
receiving nursing, aide, and therapy services when under the care of a 
home health agency?
     What additional evidence is available regarding negative 
outcomes or adverse events that may be attributable to the mix, 
duration, and service frequency provided by HHAs, including, but not 
limited to, avoidable hospitalizations?
     In what ways can referring providers and HHAs improve the 
referral process?
     What other factors may influence the provision of services 
that impact the timeliness of services and service initiation?
     What additional areas should CMS consider to address HHA 
patient health and safety concerns?

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 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

[[Page 55403]]

Act, the policy proposed in this regulation to establish the ongoing 
collection of the proposed set of data elements is necessary to quickly 
identify threats to resident health and safety and initiate requisite 
responses. The data proposed in this regulation for ongoing collection 
would support facility, State, and Federal-level public health actions 
that protect the health and safety of residents and ongoing response 
efforts. In addition, the data collected would continue to be supplied 
directly to LTC facilities, State health departments, the CDC, and CMS 
to detect infection outbreaks, monitor the impact of infection 
prevention strategies, and vaccination uptake (sections VI.B.2. through 
B.5. of this proposed rule outline specific benefits because of the 
proposed data collections).
    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 (IFC) 
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 residents. The data highlighted how LTC 
facilities played a large role in viral transmission and that LTC 
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 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 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 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 
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 
specifies a lesser frequency) and modified the specific data elements 
to be reported. The rule states that until December 31, 2024, 
facilities must electronically report, 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.
    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).\123\ This June 
2023 final rule

[[Page 55404]]

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),\124\ 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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    \123\ June 2023 Final Rule. https://www.govinfo.gov/content/pkg/FR-2023-06-05/pdf/2023-11449.pdf.
    \124\ 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.125 126 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.\127\ 
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.\128\ 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.\129\ 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.\130\
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    \125\ 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.
    \126\ 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/.
    \127\ 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.
    \128\ Vital and Health Statistics, Series 3, Number 47 (cdc.gov) 
(https://www.cdc.gov/nchs/data/series/sr_03/sr03-047.pdf).
    \129\ 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).
    \130\ 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.\131\ 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.
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    \131\ 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.
3. Benefits of Data Collection at the Facility and Local Level
    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. Efforts to support the LTC community and facility infrastructure 
include the CMS final rule titled ``Medicare and Medicaid Programs; 
Minimum Staffing Standards for Long-Term Care Facilities and Medicaid 
Institutional Payment Transparency Reporting,'' published on May 10, 
2024 (89 FR 40876).\132\ This final rule established a consistent floor 
(baseline) for nurse staffing across all LTC facilities in an effort to 
reduce the variability in nurse staffing. The final rule policies aim 
to advance equitable, safe, and quality care for all residents 
receiving care from the Nation's Medicare and Medicaid participating 
LTC facilities. The finalized minimum staffing standards coupled with 
the respiratory illness data reporting requirements proposed in this 
rule would support targeted high-quality care for residents. For 
example, timely and actionable surveillance at the facility and local 
level would support efforts to identify and allocate resources to 
maintain the appropriate care needed to keep residents safe.
---------------------------------------------------------------------------

    \132\ https://www.govinfo.gov/content/pkg/FR-2024-05-10/pdf/FR-2024-05-10.pdf.
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    Data collected from LTC facilities is used by local health 
departments to provide specific outreach to individual facilities. This 
can include interventions such as site visits from health departments, 
providing additional supplies such as PPE and/or testing supplies, 
recommendations for testing protocols and individualized advice for 
infection prevention and control practices to protect the health and 
safety of residents within individual facilities. LTC facilities care 
for some of the most vulnerable older adults who are disproportionally 
impacted by respiratory viruses and severe outcomes, such as 
hospitalizations and death. Ongoing data collection as part of a 
facility infection prevention and control program helps each facility 
to promptly identify a respiratory viral outbreak so that containment 
and important interventions, such as early anti-viral treatment (SARS-
CoV-2, Influenza) and anti-viral prophylaxis (Influenza), can minimize 
the severity of an outbreak and protect residents' health and safety. 
Identifying strategies to provide early

[[Page 55405]]

antiviral treatments for COVID-19 and influenza may also help prevent 
more serious outcomes in individual residents.
    Like other settings where health care is delivered, LTC facilities 
are part of an ecosystem caring for individuals in their community. 
This interdependency is especially highlighted during times of health 
care system strain. Insight into LTC facility capacity helps ensure 
capabilities are available to meet health care needs with quality care 
through enhanced planning, technical assistance, resource allocation, 
and coordination.\133\ Health care coalitions (HCCs) are one example of 
local health care partners working together to increase local health 
care resilience during respiratory illness surges and more.\134\ HCCs 
plan and respond together, sharing real-time information and providing 
technical assistance to support their partners.\135\ Collaborative, 
data-driven approaches have helped to inform and direct action 
throughout the health care ecosystem, ultimately improving resident 
care and outcomes.
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    \133\ https://aspr.hhs.gov/HealthCareReadiness/StoriesfromtheField/Pages/Stories/Kentucky-Collaborates-Community.aspx.
    \134\ https://aspr.hhs.gov/HealthCareReadiness/HealthCareReadinessNearYou/Documents/HCC-FactSheet-April2021-508.pdf.
    \135\ https://aspr.hhs.gov/HealthCareReadiness/HealthCareReadinessNearYou/Documents/HCC-FactSheet-April2021-508.pdf.
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    Data from LTC facilities is an important component to understanding 
potential bottlenecks in the health care ecosystem and ways to address 
them. During the COVID-19 PHE, hospitals struggled with being able to 
discharge patients to post-acute care, specifically LTC facilities. The 
availability of LTC facility capacity data helped to inform their 
response by monitoring triggers for patient load balancing, allocations 
of scarce resources, and requests for additional resources or mutual 
aid.\136\ LTC facilities, hospitals, and other health care partners 
also use the information for planning purposes, identifying how their 
facility may be impacted and preparing accordingly.\137\ Information 
sharing across the health care ecosystem helps the health care 
community to prepare for, and effectively respond to, respiratory 
illness surges in ways that maintain the safety and availability of 
critical care services.
---------------------------------------------------------------------------

    \136\ Mitchell SH, Rigler J, Baum K. Regional Transfer 
Coordination and Hospital Load Balancing During COVID-19 Surges. 
JAMA Health Forum. 2022;3(2):e215048. doi:10.1001/
jamahealthforum.2021.5048. https://aspr.hhs.gov/HealthCareReadiness/StoriesfromtheField/Pages/Stories/HCC-Regional-Approach-Illinois.aspx.
    \137\ https://aspr.hhs.gov/HealthCareReadiness/StoriesfromtheField/Pages/Stories/Maryland-HCC-covid19.aspx.
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    Additionally, since the start of the PHE, data reported under our 
requirements at Sec.  483.80(g)(1) through (3) have been used by LTC 
facilities and their local health systems to take actions aimed at 
protecting residents. Facilities can view all reported data and 
generate reports within the CDC's NHSN application. This allows 
facilities to review their data in real time and implement any 
applicable mitigation strategies/infection control practices, based on 
the counts they are seeing to help reduce outbreak occurrences. LTC 
facilities have used the CDC's NHSN dashboards and reports to track new 
cases and up-to-date vaccination status of residents in the facility 
and take action by identifying areas where they need to strengthen 
infection and control practices, explore vaccination progress, and 
consider targeted quality improvement activities as part of their 
Quality Assurance and Performance Improvement (QAPI) initiatives. LTC 
facilities can use NHSN to create custom data reports and analyses, 
tailoring the information for purposes and improvements that best meet 
their needs for protecting the residents in their care.\138\
---------------------------------------------------------------------------

    \138\ Coverage with Influenza, Respiratory Syncytial Virus, and 
Updated COVID-19 Vaccines Among Nursing Home Residents--National 
Healthcare Safety Network, United States, December 2023 [verbar] 
MMWR (cdc.gov) (https://www.cdc.gov/mmwr/volumes/72/wr/mm7251a3.htm).
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4. Benefits of Data Collection at the Regional and State Levels
    COVID-19 and other respiratory illness 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. At the State and regional levels, 
public health departments and Quality Improvement Organizations (QIOs) 
have used these data to provide outreach and technical support directly 
to LTC facilities with high case and hospitalization counts and offer 
additional resources and support. QIOs use COVID-19 case and 
vaccination data to identify LTC facility outbreaks, provide 1:1 
infection control assistance, and direct any other COVID-19 reduction 
assistance requested by those nursing homes. These data will continue 
to be critical to support the ongoing work of the QIOs. They will plan 
and provide technical assistance and training to LTC facilities 
identified by CMS for performance improvement based on quality 
measurement and enforcement data. The QIOs will also work on 
strengthening the quality management systems in LTC facilities, 
leadership and governance, culture of safety, workforce planning and 
focused clinical outcomes. Additionally, resident vaccination data 
direct the education and assistance efforts of partners like the QIOs 
and LTC associations to improve vaccination uptake in facilities with 
the lowest up-to-date vaccination rates among residents and staff. For 
example, the Nursing Home Command Center, in charge of directing QIOs, 
reviews NHSN COVID-19 case and vaccination data daily and considers 
NHSN data to be the best source to identify nursing homes in need of 
assistance to improve resident outcomes.\139\
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    \139\ Report to Congress, November 2023, for Fiscal Year 2022, 
The Administration, Cost, and Impact of the Quality Improvement 
Organization Program for Medicare Beneficiaries (https://www.cms.gov/files/document/final-fy-2022-qio-rtc.pdf).
---------------------------------------------------------------------------

    In July 2020, the Federal Government launched a strike team 
initiative to address COVID-19 outbreaks in LTC facilities. This 
initiative relied upon data reported by LTC facilities to focus 
response efforts on the facilities with the highest number of cases. 
The Federal strike team initiative highlighted significant challenges 
faced by facilities and was foundational in identifying areas of 
infection prevention and control need, such as education for front line 
nursing staff, staffing shortages, and coordination among Federal State 
and local entities.\140\ These efforts further emphasized that without 
data to direct assistance to places with the greatest need, response 
efforts and the limited resources, especially in non-emergency times of 
typical disease transmission, would be dispersed and far less 
effective. Building upon the 2020 Federal strike team efforts, a total 
of $500 million, was made available in 2021, through Sections 9402 and 
9818 of the American Rescue Plan (ARP) Act of 2021, Public Law 117-2, 
to State and local health departments through the CDC's Epidemiology 
and Laboratory Capacity (ELC) Cooperative Agreement (CK19-1904), as the 
``Nursing Home & Long-term Care Facility Strike Team and Infrastructure 
Project.'' This funding allowed States to continue dedicated support to 
LTC facilities and was used to build and maintain the infection 
prevention infrastructure necessary to

[[Page 55406]]

support resident, visitor, and facility healthcare personnel safety. 
State and local strike teams illustrated the power of public health and 
healthcare stakeholders working together to share data and information 
and collaborate effectively respond to respiratory illness surges. 
Between August 2021 and July 2022, health departments conducted over 
26,000 Nursing Home COVID-19 responses, including more than 5,000 
onsite assessments and more than 5,000 investigations that included 
staff supported specifically by Strike Team funding. For example, 
States like Massachusetts have lauded the value of the strike team 
investments and asserted that improved State and Federal data 
infrastructure is needed to respond to future outbreaks and protect 
nursing home residents.\141\
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    \140\ Protecting Nursing Home Residents from Covid-19: Federal 
Strike Team Findings and Lessons Learned [verbar] NEJM Catalyst 
(https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0144).
    \141\ https://doi.org/10.1111/jgs.18402.
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5. Benefits of Data Collection at the Federal Level
    At the Federal level, the CDC actively uses weekly NHSN data 
reports to provide direct outreach to LTC facilities with >8 COVID-19 
hospitalizations and >20 cases. These weekly reports are sent to State 
health departments to provide actionable data including confirmed 
COVID-19 cases among residents and staff, COVID-19 related deaths among 
residents, COVID-19 hospitalizations among residents, vaccine coverage 
among residents and staff, and COVID-19 potential outbreak alerts among 
other data elements. CDC also 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, 
vaccination data are critical for decision making, targeting outreach 
for vaccination campaigns efforts, insights into vaccination 
disparities \142\ and for vaccine effectiveness studies.\143\ The 
availability of vaccination data from LTC facilities, not only provides 
a window into national efforts for improving access to vaccines for the 
LTC industry, but also can indicate the effectiveness of vaccination 
training and education efforts with residents and families, that 
promote the benefits of vaccination to help ensure that residents will 
achieve the best outcome possible if infected with the SARS-CoV-2 
virus.
---------------------------------------------------------------------------

    \142\ Haanschoten E, Dubendris H, Reses HE, Barbre K, Meng L, 
Benin A, Bell JM. Disparities in COVID-19 Vaccination Status Among 
Long-Term Care Facility Residents--United States, October 31, 2022-
May 7, 2023. MMWR Morb Mortal Wkly Rep. 2023 Oct 6;72(40):1095-1098. 
doi: 10.15585/mmwr.mm7240a4. PMID: 37796756; PMCID: PMC10564329.
    \143\ 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.
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    NHSN data has also been used by the CDC and QIOs to contact 
facilities with high vaccination coverage to understand the successful 
strategies they employed and promote these strategies to other nursing 
homes via webinars and the development of tools and resources. 
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 nursing homes educate their staff, 
residents, and families to remove barriers to vaccination.
    Furthermore, COVID-19, influenza, and RSV vaccination data continue 
to be used for establishing policies that promote better protection for 
residents and staff. These data continue to serve as supporting 
evidence to make and revise recommendations regarding vaccination to 
improve the safety of residents and staff while balancing the burden to 
facilities to report. For example, early in the PHE, increasing staff 
vaccination rates was associated with lower incidence of COVID-19 cases 
and deaths among residents and staff in LTC facilities. However, as 
newer, more infectious, and transmissible variants of the virus 
emerged, increasing staff vaccination rates of the original 2-dose 
regimen of the COVID-19 vaccine as recommended in December 2020, was no 
longer associated with lower rates of adverse COVID-19 outcomes in 
nursing homes, resulting in updated recommendations to the public.\144\
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    \144\ Sinha S, Konetzka RT. Association of COVID-19 Vaccination 
Rates of Staff and COVID-19 Illness and Death Among Residents and 
Staff in US Nursing Homes. JAMA Netw Open. 2022;5(12):e2249002. 
doi:10.1001/jamanetworkopen.2022.49002.
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6. Proposed 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 
are considering 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,\145\ 
adults 65 years and older represented more than half of COVID-19 
hospitalizations during October 2023 to December 2023.\146\ 
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.\147\ 
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.\148\
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    \145\ https://covid.cdc.gov/covid-data-tracker/#trends_weeklyhospitaladmissions_select_00.
    \146\ CDC COVID Data Tracker: Hospital Admissions (https://covid.cdc.gov/covid-data-tracker/#datatracker-home).
    \147\ 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: http://dx.doi.org/10.15585/mmwr.mm7315a3.
    \148\ 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. The result of this ``new normal'' will be more burdensome 
respiratory virus seasons for the foreseeable future, which promises to 
threaten the health and safety of LTC facility residents across the 
Nation.\149\ In response to this changed landscape, 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.\150\ Likewise, we believe it is vital

[[Page 55407]]

to maintain national surveillance of these emerging and evolving 
respiratory illnesses as a means of guiding infection control 
interventions to keep residents safe. As such, we propose to continue 
some of the reporting requirements finalized in November 2021 and set 
to expire in December 2024. Specifically, we propose 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.
---------------------------------------------------------------------------

    \149\ Respiratory Disease Season Outlook (cdc.gov) (https://www.cdc.gov/forecast-outbreak-analytics/about/season-outlook.html).
    \150\ See https://www.cdc.gov/respiratory-viruses/index.html 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.
---------------------------------------------------------------------------

    Specifically, we propose 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, facilities would 
be required to electronically report information about COVID-19, 
influenza, and RSV in a standardized format and frequency specified by 
the Secretary. Currently, we propose to continue weekly reporting 
through the CDC's NHSN. To the extent to be determined by the 
Secretary, through this rulemaking cycle, we propose 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).
    These proposals are scaled back and tailored from the current post-
COVID-19 PHE requirements, continuing the collection of the minimal 
necessary data to maintain a level of situational awareness that would 
protect resident health and safety in LTC facilities across the country 
while reducing reporting burden on those facilities. We are also 
interested in the utility of additional reporting on limited 
demographic data and solicit public comment on whether the collection 
of data regarding race, ethnicity, and socioeconomic status should be 
explicitly included as part of these proposed requirements for ongoing 
reporting beginning on January 1, 2025. We are particularly interested 
in comments that address the ways these additional data elements could 
be used to better protect resident and community health and safety both 
during and outside of a declared PHE. In addition, we are interested in 
comments on how to protect resident privacy within demographic groups 
and how to best use the data to inform public health efforts without 
stigmatizing demographic groups.\151\ Lastly, we welcome comments that 
address system readiness and capacity to collect and report these data.
---------------------------------------------------------------------------

    \151\ Landers S, Kapadia F, Tarantola D. Monkeypox, After HIV/
AIDS and COVID-19: Suggestions for Collective Action and a Public 
Health of Consequence, November 2022. Am J Public Health. 2022 
Nov;112(11):1564-1566. doi: 10.2105/AJPH.2022.307100. PMID: 
36223580; PMCID: PMC9558195. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9558195/.
---------------------------------------------------------------------------

    In determining the data elements to propose for ongoing reporting, 
we considered the data elements that proved most actionable and 
informative over the course of the COVID-19 PHE, with evidence of 
protecting health and safety, as well as more recent lessons that have 
emerged during the 2023-2024 respiratory virus 
response.152 153 We also considered ways to balance the 
burden of reporting on LTC facilities with the need to maintain a level 
of situational awareness that will benefit residents, their families, 
and their communities.
---------------------------------------------------------------------------

    \152\ https://emergency.cdc.gov/han/2023/han00503.asp, https://emergency.cdc.gov/han/2023/han00498.asp.
    \153\ Coverage with Influenza, Respiratory Syncytial Virus, and 
Updated COVID-19 Vaccines Among Nursing Home Residents--National 
Healthcare Safety Network, United States, December 2023 [verbar] 
MMWR (cdc.gov) (https://www.cdc.gov/mmwr/volumes/72/wr/mm7251a3.htm#F1_down).
---------------------------------------------------------------------------

    In the absence of a declared national PHE for an acute respiratory 
illness, we propose that LTC facilities would continue to report these 
data on a weekly basis through a format specified by the Secretary with 
continued reporting through the CDC's NHSN. Sustained data collection 
and reporting outside of emergencies would help ensure that LTC 
facilities maintain a functional reporting capacity that could be 
mobilized quickly when a new threat emerges to inform and direct 
response efforts (for example, resource allocations) that protect 
residents and their communities. These data collections would also 
provide the baseline information necessary to forecast, detect, 
quantify and, ultimately, direct responses to signals of strain within 
regions and LTC facilities.
    Unlike the previous and sunsetting LTC reporting requirements, the 
requirements proposed in this rule are not tied to a specific PHE 
declaration. PHE declarations are valuable tools for marshalling nimble 
and fast emergency responses. However, there are many respiratory 
disease threats to LTC facility operations and resident safety that 
would not necessarily be subject to a PHE declaration nor have 
significant potential to become a PHE. In those instances, routine data 
about cases and hospitalizations due to respiratory viruses like COVID-
19, influenza, and RSV are critical to inform technical assistance, 
infection prevention and control support, and resource allocations to 
support LTC facilities and safeguard their residents.
    We welcome public comments on our proposals, and on ways that 
reporting burden can be minimized while still providing adequate data. 
We also welcome 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. Finally, we welcome comments on the value of these data in 
protecting the health and safety of individuals receiving care and 
treatment and working in LTC facilities.
7. Proposed 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,\154\ a feedback loop 
between increased stress on hospitals, LTC facilities, illness in the 
community, and patient and resident health and safety.

[[Page 55408]]

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.\155\ \156\ 
Specifically in LTC facilities, the significant adverse health impacts 
on residents caused by COVID-19 went far beyond the direct effects of 
COVID-19 morbidity and mortality.\157\ 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 propose additional 
data reporting that would be required in the event of an acute 
respiratory illness PHE, or after the Secretary's determination that a 
significant threat of one exists.
---------------------------------------------------------------------------

    \154\ 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/).
    \155\ 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/).
    \156\ https://www.nejm.org/doi/full/10.1056/NEJMp2118285.
    \157\ 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/).
---------------------------------------------------------------------------

    Accordingly, we propose that during a declared national, State, or 
local PHE for a respiratory infectious disease (or if the Secretary 
determines a significant 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 invite comments on if, during a PHE, there should be limits to 
the data the Secretary can require without notice and comment 
rulemaking, 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 seek 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 
invite 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 invite 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?
8. Collaboration
    To further reduce burden in the short term, we are working with the 
CDC to ensure LTC facilities can continue to use existing, established 
systems to report data in the interim. CDC will continue increasing the 
automation capabilities of the surveillance systems like NHSN and its 
ability to connect with other data submission techniques, vendors, and 
systems.\158\ CDC is collaborating with LTC partner organizations and 
State health departments to pilot projects aimed at streamlining and 
modernizing vaccination data reporting. This includes efforts to 
automate reporting of LTC facility vaccination data from electronic 
health records to NHSN and to connect person-level vaccination data in 
NHSN to State Immunization Information Systems (IIS). These 
modernization efforts should reduce the reporting burden on facilities 
over time. In addition, CDC provides users with technical assistance, 
targeted data quality outreach and webinars, and continues to actively 
collaborate with users and partners to improve system design and 
functionality. For example, the development of the NHSN person-level 
vaccination forms allowed for complex definitions that change over time 
(for example, up to date with COVID-19 vaccines) to be applied 
automatically to and aggregate resident-level data.
---------------------------------------------------------------------------

    \158\ For more information about USCDI+ https://www.healthit.gov/topic/interoperability/uscdi-plus.
---------------------------------------------------------------------------

    CMS, CDC, and the Administration for Strategic Preparedness and 
Response (ASPR) recognize the immense value of partnerships with LTC 
facilities, State, Tribal, Local, and Territorial (STLT) health 
systems, associations, and other partners. Throughout the COVID-19 PHE, 
partners at all levels worked alongside CMS, CDC, and ASPR to provide 
additional context, insight, and feedback based on conditions on the 
ground. This context helped data collections be more effective and 
helped provide a fuller picture than data alone. CMS, CDC, and ASPR are 
grateful for the many collaborations with partners on data and beyond. 
CDC, ASPR, and the Office of the National Coordinator for Health 
Information Technology (ONC) will explore opportunities to codify 
continued partnerships to prepare for and respond to incidents such as 
respiratory illnesses more effectively. We welcome public comment on 
ways that all public agencies involved in these types of data 
collections can be good partners.

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 and hereafter 
occasionally referenced as subpart P). They address, among other 
things, requirements that providers and suppliers must meet to obtain 
and maintain Medicare billing privileges.
    As outlined in Sec.  424.510, one such requirement is that the 
provider or supplier must complete, sign, and submit to its assigned 
Medicare Administrative Contractor (MAC) the appropriate enrollment 
form, typically the Form CMS-855 (OMB Control No. 0938-0685). The Form 
CMS-855, which can be submitted via paper or electronically through the 
internet-based Provider Enrollment, Chain, and Ownership System (PECOS) 
process (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

[[Page 55409]]

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 VIII.B. of this proposed rule, 
we are proposing a change to our existing Medicare provider enrollment 
regulations.
2. Legal Authorities
    There are two principal categories of legal authorities for our 
proposed Medicare provider enrollment provisions:
     Section 1866(j) of the Act furnishes specific authority 
regarding the enrollment process for providers and suppliers.
     Sections 1102 and 1871 of the Act provide general 
authority for the Secretary to prescribe regulations for the efficient 
administration of the Medicare program.

B. Proposed Provisions--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.) 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).\159\ 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.)
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    \159\ 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.
    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.
    Our interpretation is also supported by the fact that a significant 
number of our grounds for deactivation under

[[Page 55410]]

Sec.  424.540(a) involve conduct or inaction in which the provider or 
supplier--as with a revocation--is not adhering to Medicare enrollment 
requirements. These include, for example, the provider or supplier--
     Failing to report a change to the information supplied on 
the enrollment application within the required timeframe (Sec.  
424.540(a)(2));
     Failing to timely respond to a revalidation request (Sec.  
424.540(a)(3));
     Failing to maintain compliance with all enrollment 
requirements (Sec.  424.540(a)(4)); and
     Having a non-operational or otherwise invalid practice 
location (Sec.  424.540(a)(5)).
    The provider or supplier can also be revoked under Sec.  424.535(a) 
on any of these bases (for instance, under Sec.  424.535(a)(1) relating 
to noncompliance). Because these bases are overlapping, it is CMS' 
principled view that reactivating providers and suppliers that were 
deactivated for any of these reasons should be subject to the same PPEO 
scrutiny. CMS has a legitimate oversight interest that the prior non-
compliance has been corrected and that adherence will continue after 
their reactivation, which would be satisfied through the post-
enrollment monitoring the PPEO affords.
    Concerning our other deactivation grounds, Sec.  424.540(a)(1) 
permits CMS to deactivate a provider or supplier that has not billed 
Medicare for 6 consecutive months. We recognize that there may be a 
legitimate reason for which a provider or supplier ceases billing 
Medicare for an extended period. (For example, a provider enrolls in 
Medicare strictly to enroll in and bill another health care program.) 
At the same time, a reactivation request after months of billing 
inactivity raises questions as to whether--
     The provider or supplier is and will remain compliant with 
Medicare enrollment requirements once reactivated following such a 
period of non-billing;
     Another party has compromised the provider's or supplier's 
deactivated enrollment and billing privileges and seeks to fraudulently 
bill Medicare via the latter's reactivated enrollment; or
     The provider or supplier had secured multiple billing 
numbers, one of which was revoked for improper activity, another was 
deactivated for non-billing, and the provider or supplier now seeks to 
reactivate the latter number to bill for services that were previously 
furnished under the revoked number.
    CMS has indeed identified such scenarios in its program integrity 
oversight activities. We believe that using a PPEO to closely monitor 
reactivated providers or suppliers that had been deactivated under 
Sec.  424.540(a)(1) would help prevent improper activity and help 
ensure program integrity where the PPEO applies.
    Deactivation can also occur under Sec.  424.540 if: (1) the 
provider or supplier is voluntarily withdrawing from the Medicare 
program (that is, voluntarily terminating its Medicare enrollment) 
(Sec.  424.540(a)(7)); (2) the provider is the seller (and is hence 
leaving the Medicare program) in an HHA change in majority ownership 
under Sec.  424.550(b) (Sec.  424.540(a)(8)); or (3) an individual 
provider or supplier is deceased (Sec.  424.540(a)(6)). The same 
concerns we expressed regarding reactivations following a Sec.  
424.540(a)(1) deactivation apply to these three deactivation bases. If 
a reactivation request arrives after the provider or supplier was 
deactivated upon departing the Medicare program, the provider's or 
supplier's former enrollment may have been compromised by an 
unscrupulous party. Even if no improper conduct is involved and the 
voluntarily terminated provider or supplier simply wishes to reenter 
and resume billing Medicare, they are effectively returning to the 
program as a new provider or supplier after having departed. This 
situation is not appreciably different from that where the provider or 
supplier is enrolling in Medicare for the first time. Given this, we 
believe that providers and suppliers that are reactivating their 
enrollment after having left the Medicare program should be subject to 
the same PPEO analysis as other providers and suppliers who are treated 
as an initial enrollee for Medicare provider enrollment purposes, for 
consistency and uniformity.
    For all the foregoing reasons, we propose 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 have elected to address this issue via rulemaking in 
proposed 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 subregulatory guidance.

VIII. Collection of Information Requirements

A. Statutory Requirement for Solicitation of Comments

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

B. Information Collection Requirements (ICRs)

    In the CY 2024 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 proposed rule, we are 
proposing to collect four additional items as standardized patient 
assessment data elements and replace 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 proposed 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 assume the Food Runs Out and Food 
Doesn't Last data elements require 0.15 minutes each of clinician time 
to complete. We assume 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

[[Page 55411]]

in clinician burden per OASIS assessment of 0.9 minutes at start of 
care.
    As stated in section III.E. of this proposed rule, CMS is also 
proposing 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 
proposal 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 proposals 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 (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 41.
[GRAPHIC] [TIFF OMITTED] TP03JY24.070

    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 41 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 42 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 thirty 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] TP03JY24.071

    The totals from table 42 are used to calculate the hourly burden 
estimates in table B3 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.


[[Page 55412]]


 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 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 = 929,925hours 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 43 summarizes the estimated clinician hourly burden for the 
OASIS that will be implemented in 2027 with this 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 calculate the 2025 and 
2027 burden estimate in minutes and then calculate an hourly burden 
shown in table 43. 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] TP03JY24.072

    Table 44 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 43 by the weighted clinician average 
hourly wage of $85.74. We then calculate 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 estimate an increase in 
clinician costs $12,604,894.62 between 2027 and 2025 related to the 
implementation of the proposals outlined in this proposed 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] TP03JY24.073

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 proposed rule do not result in an 
increase in costs to HHAs. Section 1115A(d)(3) of the Act exempts 
Innovation Center model tests and expansions, which include the 
expanded HHVBP Model, from the provisions of the PRA. Specifically, 
this section provides that the provisions of the PRA do not apply to 
the testing and evaluation of Innovation Center models or to the 
expansion of such models.

3. ICRs Related to Conditions of Participation (CoPs): Organization and 
Administration of Services (Sec.  484.105)


[[Page 55413]]


    In section VII.A. of this proposed rule, we discuss 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 propose 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 
proposed 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 estimate there are 9,565 Medicare-certified HHAs and that this 
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 ($82.76 + 
$239.08) and $3,078,400 for all HHA's ($791,599 + $2,286,800). We also 
estimate 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 per HHA ($82.76 x 5/60 minute = $6.90) or $65,999 
for all HHAs ($6.90 x 9,565 = $65,999) to fulfill this requirement.
[GRAPHIC] [TIFF OMITTED] TP03JY24.074

[GRAPHIC] [TIFF OMITTED] TP03JY24.075

    In addition, we estimate this proposed new 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 ($41.70 hour x 15/60 minutes = 
$10.43) or $99,763 for all HHA's ($10.43 x 9,565) to fulfill the 
requirement. We also estimate 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 ($41.70 x 5/60 minute = $3.48) or $33,286 for all 
HHA's (3.48 x 9,565 = $33,286) to fulfill this requirement.
    Administrative professional: https://www.bls.gov/oes/current/oes436013.htm.
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

[[Page 55414]]

suppliers--as the Secretary determines appropriate, including 
categories of providers or suppliers--will be subject to enhanced 
oversight. These procedures have been codified in Sec.  424.527. As 
explained in section VII. of this proposed rule, we are proposing 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). We do not anticipate any ICR burdens associated with 
this provision, for we are merely expanding an existing regulatory 
definition.
5. ICRs Related to LTC Requirements for Acute Respiratory Illness 
Reporting Sec.  483.80(g)
    The ICR burden currently associated with Sec.  483.80(g) is 
included under OMB control number 0938-1363; expiration date: April 30, 
2026.
    In section VII.B. of this proposed rule we discuss our proposals 
related to LTC requirements for acute respiratory illness reporting. At 
Sec.  483.80(g)(1)(i) through (ix) and (g)(2), we propose 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 propose that the data elements for which reporting would be 
required 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 propose that LTC facilities would continue to report these 
data on a weekly basis through a format specified by the Secretary and 
specifically we intend to continue reporting through the CDC's NHSN. 
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.
    These proposals are scaled back and tailored from the current post-
COVID-19 PHE requirements, continuing the collection of the minimal 
necessary data to maintain a level of situational awareness that would 
protect resident health and safety in LTC facilities across the country 
while reducing reporting burden on those facilities. However, during a 
declared Federal, state, or local PHE for a respiratory infectious 
disease we also propose 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, and relevant medical countermeasures and therapeutics 
inventories, usage, or both, and additional demographic factors.
    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 new proposals. 
We estimate 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 this 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 have 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.\160\
---------------------------------------------------------------------------

    \160\ 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 estimate 
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 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. 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 acknowledge 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 are 
including two burden estimates to cover a range in 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 estimate 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 estimate 
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.
    In summary the total annual burden for all LTC facilities for these 
proposed ICRs is 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

[[Page 55415]]

facility annually. We will submit the revised information collection 
request to OMB for approval under OMB control number 0938-1363.
[GRAPHIC] [TIFF OMITTED] TP03JY24.076

    We welcome public comments on our ICR burden estimates, and on ways 
that reporting burden can be minimized while still providing adequate 
data. We also welcome 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 welcome comments that address system 
readiness and capacity to collect and report these data.

C. Submission of PRA-Related Comments

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

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

[[Page 55416]]

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 proposed rule, 
we include a request for information (RFI) related to the future 
measure concepts for the expanded HHVBP Model. We also provide an 
update on potential future approaches for integrating health equity 
that are being considered for the expanded HHVBP Model.
4. Home IVIG Items and Services
    Division FF, section 4134 of the CAA, 2023 (Pub. L. 117-328) 
mandated that CMS establish a permanent, bundled payment for items and 
services related to administration of IVIG in a patient's home. The 
permanent, bundled home IVIG items and services payment is effective 
for home IVIG infusions furnished on or after January 1, 2024. Payment 
for these items and services is required to be a separate bundled 
payment made to a supplier for all items and services furnished in the 
home during a calendar day. This payment amount may be based on the 
amount established under the Demonstration. The standard Part B 
coinsurance and the Part B deductible apply. The separate bundled 
payment does not apply for individuals receiving services under the 
Medicare home health benefit. The CAA, 2023 provision clarifies that a 
supplier who furnishes these services meet the requirements of a 
supplier of medical equipment and supplies.
5. 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 is specifically 
limited to Medicare beneficiaries. As explained in section VI.A. of 
this proposed rule, we are proposing 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 propose that HHAs would be required to make specified information 
about their services and service limitations available to the public. 
In this proposed rule, we include a request for information (RFI) to 
obtain information from stakeholders on whether CMS should shift its 
longstanding policy and permit rehabilitative therapists to conduct the 
initial and comprehensive assessment for cases that have both therapy 
and nursing services ordered as part of the plan of care. In addition, 
we are seeking public comments on other factors that influence the 
patient referral and intake processes.
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. These procedures have 
been codified in 42 CFR 424.527. As explained in section VII. of this 
proposed rule, we are proposing 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 proposing streamlined weekly data reporting requirements for 
certain respiratory illnesses. We are also proposing additional, 
related data elements that could be activated in the event of a future 
acute respiratory illness PHE.

B. Overall Impact

    We have examined the impacts of this proposed 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 or the 
principles set forth in this Executive order.
    A regulatory impact analysis (RIA) must be prepared for significant 
rules.

[[Page 55417]]

Based on our estimates, OMB'S Office of Information and Regulatory 
Affairs has determined this rulemaking is significant per section 
3(f)(1) as measured by the $200 million or more in any 1 year. 
Accordingly, we have prepared a regulatory impact analysis that to the 
best of our ability presents the costs and benefits of the rulemaking. 
Therefore, OMB has reviewed this proposed rule, and the Departments 
have provided the following assessment of their impact. We solicit 
comments on the regulatory impact analysis provided.

C. Detailed Economic Analysis

1. Effects of the Proposed Changes for the CY 2025 HH PPS
    This rule proposes to update 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 -$280 million (-1.7 
percent). The $280 million decrease in estimated payments for CY 2025 
reflects the effects of the proposed CY 2025 home health payment update 
percentage of 2.5 percent ($415 million increase), an estimated 3.6 
percent decrease that reflects the effects of the permanent adjustment 
($595 million decrease), and an estimated 0.6 percent decrease that 
reflects the effects of an updated FDL ($100 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 48 represents how HHA revenues are likely to be affected by 
the proposed 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 48 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 proposed -4.067 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 proposed update to the LUPA add-on factors. The seventh column 
shows the payment effects of the proposed 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 
proposed provisions.
    Overall, it is projected that aggregate payments in CY 2025 would 
decrease by 1.7 percent which reflects the 3.6 percent decrease from 
the permanent adjustment, the 2.5 payment update percentage increase, 
and the 0.6 percent decrease from increasing the FDL. As illustrated in 
table 48, 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 Proposed 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.
    This proposed rule proposes to collect four additional items as 
standardized patient assessment data elements and replace 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. CMS is also 
proposing 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 is 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 proposed rule provides a detailed 
description of the net increase in burdens 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 $12,604,894.62 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 proposed rule. In summary, the 
implementation of proposals outlined in this proposed rule for the HH 
QRP is estimated to increase the burden on HHAs by $1,058.88 per HHA 
annually, or $12,604,894.62 for all HHAs annually.
3. Effects of the Expanded HH VBP Model
    There are no proposed changes to the expanded HHVBP Model for CY 
2025. Therefore, we assume there are no impacts resulting from this 
proposed rule. 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 this 
proposed rule, will be summarized in the final rule and may inform 
proposals through future rulemaking.
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 proposed rule as 
added by section 4134 of the CAA, 2023 and accordingly, describes the 
impact for CY 2025 only. Table 49 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 proposed CY 2025 home IVIG items and services rate. The fifth 
column estimates the cost to Medicare for CY 2025 ($9,435,233). Table 
50 represents the estimated impacts of the home IVIG items and services 
payment for CY 2025 by census region.
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[[Page 55421]]


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5. HHA CoP Changes: Establishing an Acceptance to Service Policy
    We propose to add a new standard Sec.  484.105(i), which sets forth 
a requirement for HHAs to establish an acceptance to service policy. 
All cost associated with this policy are located in the section VIII. 
of this proposed rule (Collection of Information). There are no 
transfers associated with this requirement.
6. Provider Enrollment Provisions
    For purposes of applying a PPEO, we are proposing 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). However, we 
are 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 can formulate a burden projection. 
Second, we cannot predict the scope, extent, and length of any future 
PPEO or the provider or supplier type(s) to which it may apply. 
Accordingly, we solicit public comment from stakeholders on the 
potential burden of our expansion of Sec.  424.527(a).
7. Effects of the Proposed LTC Requirements for Acute Respiratory 
Illness Reporting
    We propose 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 
proposed rule (Collection of Information). There are no transfers 
associated with this requirement. We welcome public comments on our 
estimates, and on ways that reporting burden can be minimized while 
still providing adequate data. We also welcome 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 
welcome comments that address system readiness and capacity to collect 
and report these data.

D. Regulatory Review Cost Estimation

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this proposed rule, we 
should estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review the rule, we assume that the total number of unique 
commenters on last year's proposed rule will be the number of reviewers 
of this proposed rule. We acknowledge that this assumption may 
understate or overstate the costs of reviewing this proposed rule. It 
is possible that not all commenters reviewed last year's rule in 
detail, and it is also possible that some reviewers chose not to 
comment on the proposed rule. For these reasons we thought that the 
number of past commenters would be a fair estimate of the number of 
reviewers of this proposed rule. We welcome any comments on the 
approach used in estimating the number of entities reviewing this 
proposed rule.
    We recognize that different types of entities are in many cases 
affected by mutually exclusive sections of this proposed rule. 
Therefore, for the purposes of our estimate we assume that each 
reviewer reads approximately 50 percent of the rule. Finally, in our 
estimates, we have used the 948 number of timely pieces of 
correspondence on the CY 2024 HH PPS proposed rule as our estimate for 
the number of reviewers of this proposed rule. We continue to 
acknowledge the uncertainty involved with using this number, but we 
believe it is a fair estimate due to the variety of entities affected 
and the likelihood that some of them choose to rely (in full or in 
part) on press releases, newsletters, fact sheets, or other sources 
rather than the comprehensive review of preamble and regulatory text. 
We seek comments on this assumption. Using the median hourly wage 
information from the BLS for medical and health service managers (Code 
11-9111), we estimate that the cost of reviewing the proposed 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

[[Page 55422]]

it would take approximately 2.77 hours for the staff to review half of 
this proposed rule. For each entity that reviews this proposed rule, 
the estimated cost is $294.78 (2.77 hours x $106.42). Therefore, we 
estimate that the total cost of reviewing this proposed rule is 
$279,451 ($294.78 x 948 reviewers).

E. Alternatives Considered

1. HH PPS
    For the CY 2025 HH PPS proposed rule, we considered alternatives to 
the provisions articulated in section II.C. of this proposed rule. As 
described in section II.C.1.b. of this proposed rule, we proposed a 
mapping of three OASIS items (therapies, vision, and pain) 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 
proposing the mapping methodology; however, to continue with the best 
reading of the law and the finalized methodology for assessing behavior 
changes we proposed the OASIS mapping.
    As described in section II.C.1.g. of this proposed 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 proposed -4.067 percent permanent adjustment 
included halving the proposed permanent adjustment similar to how we 
finalized the permanent adjustment for CY 2024. 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 believe that a reduction, a phase-in 
approach, or delay in the permanent adjustment would not be 
appropriate, as reducing, phasing in, or delaying the permanent 
adjustment would further impact budget neutrality and likely lead to a 
compounding effect creating the need for a larger reduction to the 
payment rate in future years.
    We also considered proposing to implement the one-time temporary 
adjustment to reconcile retrospective overpayments in CYs 2020, 2021, 
2022, and 2023. However, as stated previously in this proposed rule, we 
believe that implementing both the permanent and temporary adjustments 
to the CY 2025 payment rate may adversely affect HHAs given the 
magnitude of the adjustment to the payment rate in a single year. 
Likewise, section 1895(b)(3)(D)(iii) of the Act gives CMS the authority 
to make any temporary adjustment in a time and manner appropriate 
though notice and comment rulemaking. Therefore, we believe it is best 
to propose only the implementation of the permanent decrease of 4.067 
percent to the CY 2025 base payment rate.
    Finally, we considered not proposing to adopt the 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.
2. Home IVIG Items and Services
    For the CY 2025 HH PPS proposed rule, we did not consider 
alternatives to implementing 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.

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 51, we have prepared an accounting 
statement showing the classification of the transfers and benefits 
associated with the CY 2025 HH PPS provisions of this proposed 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 52, 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.
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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 53, we have prepared an accounting 
statement showing the classification of the transfers and benefits 
associated with the CY 2025 IVIG provisions of this proposed 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 
\161\ and approximately 96 percent of HHAs are considered small 
entities. Table 54 shows the number of firms, revenue, and estimated 
impact per home health care service category.
---------------------------------------------------------------------------

    \161\ https://www.sba.gov/sites/sbagov/files/2023-03/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023.xlsx.
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    The economic impact assessment is based on estimated Medicare 
payments (revenues) and HHS's practice in interpreting the RFA is to 
consider effects economically ``significant'' only if greater than 5 
percent of providers reach a threshold of 3 to 5 percent or more of 
total revenue or total costs. The majority of HHAs' visits are Medicare 
paid visits and therefore the majority of HHAs' revenue consists of 
Medicare payments. Based on our analysis, we conclude that the policies 
proposed in this rule would result in an estimated total impact of 3 to 
5 percent or more on Medicare revenue for greater than 5 percent of 
HHAs. Therefore, the Secretary has determined that this HH PPS proposed 
rule will have significant economic impact on a substantial number of 
small entities. Specifically, we estimate that the net impact of the 
policies in this proposed rule will have a significant impact on 
hospices in the

[[Page 55424]]

New England, Mid Atlantic, and Pacific regions, which is reflected in 
the last column in table 48 as a greater than 33 percent decrease in 
expenditures when comparing CY 2025 payments to estimated CY 2024 
payments. The reason for the net decrease in CY 2025 is mostly driven 
by the impact of the permanent adjustment reflected in the third column 
of table 48. Further detail is presented in table 48, by HHA type and 
location.
    Regarding options for regulatory relief, we note that section 
1895(b)(3)(D)(i) of the Act requires CMS to annually determine the 
impact of differences between the assumed behavior changes finalized in 
the CY 2019 HH PPS final rule with comment period (83 FR 56455) and 
actual behavior changes on estimated aggregate expenditures under the 
HH PPS with respect to years beginning with 2020 and ending with 2026. 
Additionally, section 1895(b)(3)(D)(ii) and (iii) of the Act requires 
us to make permanent and temporary adjustments to the payment rate to 
offset for such increases or decreases in estimated aggregate 
expenditures through notice and comment rulemaking. While we find that 
the -4.067 percent permanent adjustment, described in section II.C.1.g. 
of this proposed rule, is necessary to offset the increase in estimated 
aggregate expenditures for CYs 2020 through 2023 based on the impact of 
the differences between assumed behavior changes and actual behavior 
changes, we will also continue to reprice claims, per the finalized 
methodology, and make any additional adjustments at a time and manner 
deemed appropriate in future rulemaking. As discussed previously, we 
also explored alternatives to the proposed -4.067 percent permanent 
adjustment including a phase-in approach, where we could reduce the 
permanent adjustment, by spreading out the CY 2025 permanent adjustment 
over a period of years. Another alternative would be to delay the 
permanent adjustment to a future year. However, we believe that a 
reduction to the permanent adjustment, a phase-in approach, or delay in 
the permanent adjustment would not be appropriate, as reducing, phasing 
in, or delaying the permanent adjustment would further impact budget 
neutrality and likely lead to a compounding effect creating the need 
for a larger reduction to the payment rate in future years. We also 
considered proposing to implement the one-time temporary adjustment to 
reconcile retrospective overpayments in CYs 2020, 2021, 2022, and 2023. 
However, as stated previously in this proposed rule, we recognize that 
applying the full permanent and temporary adjustments to the CY 2025 
payment rate may adversely affect HHAs, including small entities. We 
are soliciting comments on the overall HH PPS RFA analysis.
    Among the over 7,500 HHAs that are estimated to qualify to compete 
in the expanded HHVBP Model, we estimate that the percent payment 
adjustment resulting from this proposed rule would be larger than 3 
percent, in magnitude, for about 28 percent of competing HHAs 
(estimated by applying the proposed 5-percent maximum payment 
adjustment under the expanded Model to CY 2019 data). As a result, more 
than the RFA threshold of 5-percent of HHA providers nationally would 
be significantly impacted. We refer readers to tables 43 and 44 in the 
CY 2022 HH PPS final rule (86 FR 62407 through 62410) for our analysis 
of payment adjustment distributions by State, HHA characteristics, HHA 
size, and percentiles.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 603 of RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a metropolitan statistical area and has fewer 
than 100 beds. This proposed rule is not applicable to hospitals. 
Therefore, the Secretary has certified that this proposed rule would 
not have a significant economic impact on the operations of small rural 
hospitals.

H. Unfunded Mandates Reform Act (UMRA)

    Section 202 of UMRA of 1995 UMRA also requires that agencies assess 
anticipated costs and benefits before issuing any rule whose mandates 
require spending in any 1 year of $100 million in 1995 dollars, updated 
annually for inflation. In 2024, that threshold is approximately $183 
million. This proposed rule would not impose a mandate that will result 
in the expenditure by State, local, and Tribal governments, in the 
aggregate, or by the private sector, of more than $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 proposed rule under these criteria 
of Executive Order 13132 and have determined that it would not impose 
substantial direct costs on State or local governments.

J. Conclusion

    In conclusion, we estimate that the provisions in this proposed 
rule will result in an estimated net decrease in home health payments 
of 1.7 percent for CY 2025 (-$280 million). The $280 million decrease 
in estimated payments for CY 2025 reflects the effects of the proposed 
CY 2025 home health payment update percentage increase of 2.5 percent 
($415 million increase), a 0.6 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 ($100 million decrease), and an estimated 3.6 percent decrease 
in payments that reflects the effects of the permanent behavior 
adjustment ($595 million decrease). In addition, the estimated 
aggregate impacts of the home IVIG items and services payment for CY 
2025 is $9.4 million. Lastly, the implementation of the HH QRP proposed 
policy is estimated to increase the costs to HHAs by $1,058.88 per HHA 
annually, or $12,604,894.62 in the aggregate for HHAs annually.

X. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.
    Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & 
Medicaid Services, approved this document on June 12, 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

[[Page 55425]]

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 proposes to amend 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, SARS-CoV-2/COVID-19, and 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 or determined that a significant threat for one 
exists, 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) 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. The 
information is reviewed at least annually.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-14254 Filed 6-26-24; 4:15 pm]
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