[Billing Code: 4120-01-P]

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.
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 HomeHealthPolicy@cms.hhs.gov.
For information about the Home Health Quality Reporting Program (HH QRP), send
your inquiry via email to HHQRPquestions@cms.hhs.gov.
For more information about the expanded Home Health Value-Based Purchasing Model,
please visit the Expanded HHVBP Model webpage at https://innovation.cms.gov/innovationmodels/expanded-home-health-value-based-purchasing-model.
Frank Whelan (410) 786-1302, for Medicare provider and supplier enrollment inquiries.
Mary Rossi-Coajou at mary.rossi-coajou@cms.hhs.gov or Molly Anderson at
molly.anderson@cms.hhs.gov, for more information about the home health conditions of
participation (HH CoPs).
Kim Roche (kim.roche1@cms.hhs.gov), 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
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
§ 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 suppliersas the Secretary determines appropriate, including categories of
providers or supplierswill 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 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 pervisit payment amounts by the home health payment update percentage, and the OT LUPA addon 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
§ 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
suppliersas the Secretary determines appropriate, including categories of providers or
supplierswill 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
TABLE 1: SUMMARY OF COSTS, TRANSFERS, AND BENEFITS
Provision Description
CY 2025 HH PPS
Payment Rate Update

Costs and Cost Savings

*The estimated 3.6 percent decrease
related to the proposed behavior
assumption adjustment includes all
payments, while the proposed -4.067
percent BA adjustment only applies to
the national, standardized 30-Day period
payments and does not impact payments
for 30-day periods which are LUPAs.
The total economic impact of these
proposals including the addition of one
Living Situation item, two Food items,
and one Utilities item, and the
modification of the current
Transportation item proposed for
implementation in CY 2027 is an
estimated increase of $12,604,894.62
There are no transfers related to the RFI
or the HE Update.

HH QRP

Expanded HHVBP
Model
CY 2025 Home IVIG
Items and Services
Payment Rate Update
Home Health CoP
Changes

Transfers
The overall economic 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
CY 2025 proposed 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 behavior assumption
adjustment ($595 million decrease) and
an estimated 0.6 percent decrease that
reflects the effects of an updated FDL
($100 million decrease).

To develop, implement, and maintain
through an annual review the
acceptance to service policy, we
expect a one-time cost to develop the
policy at a total of $3,078,400 for all
HHA’s and $ $65,999 for an annual
review.

The overall economic impact for CY
2025 is an estimated increase of
$9,435,233 in total costs to Medicare
FFS.
No transfers related to this policy.

Benefits
To ensure that home health payments are
consistent with statutory payment authority
for CY 2025.

Collection of the new SDOH items will also
permit us to develop the statistical tools
necessary to maximize the value of
Medicare data, reducing costs and
improving the quality of care for all
beneficiaries.
The purpose of the RFI and HE updates is
to obtain feedback on potential new
performance measures and measure
concepts for potential future rulemaking.
To update the items and services payment
under the home intravenous immune
globulin benefit in accordance with section
4134 of the CAA of 2023.
To improve the referral process and reduce
avoidable care delays by helping to ensure that
referring entities and patients+ can select the
most appropriate HHA based on their care
needs and to make this information available
to the public.

To make specified information
publicly available, we estimate a
onetime cost of $99,763 for all HHA’s
and $33,286 for an annual update.

Provider Enrollment
Provisions

To strengthen CMS’ ability to detect and
deter Medicare fraud, waste, and abuse by
reactivating providers and suppliers.

Provision Description
Long-Term Care
(LTC) Requirements
for Acute Respiratory
Illness Reporting

Costs and Cost Savings
To review and update the facility’s
infection control policies and
procedures we estimate a cost of
$182 per LTC facility. To
electronically report the required
data, we estimate costs ranging
from $4,732 to $33,215 per LTC
facility depending on the required
reporting frequency as determined
by the Secretary. The low estimate
is based on weekly reporting and
the high estimate is based on daily
reporting. In total, we estimate costs
ranging from $4,914 to $33,397 per
LTC facility to comply with the
proposed requirements.

Transfers
No transfers related to this policy.

Benefits
To continue national monitoring of
COVID-19, Influenza, and respiratory
syncytial virus (RSV) cases to guide
infection control interventions and LTC
facility operations that directly relate to
resident safety; monitor emerging and
evolving respiratory illnesses; guide and
motivate community-level disease control
interventions; and enhance preparedness
and resiliency to improve health system
responses to future threats, including
pandemics that pose catastrophic risks to
resident safety and the health care system.

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 § 484.225(h) and (i) in accordance with the statute. The pay-for-reporting
requirement was implemented on January 1, 2007.
Section 51001(a)(1)(B) of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L.
115-123) amended section 1895(b) of the Act to require a change to the home health unit of
payment to 30-day periods beginning January 1, 2020. Section 51001(a)(2)(A) of the BBA of
2018 added a new subclause (iv) under section 1895(b)(3)(A) of the Act, requiring the Secretary

to calculate a standard prospective payment amount (or amounts) for 30-day units of service
furnished that end during the 12-month period beginning January 1, 2020, in a budget neutral
manner, such that estimated aggregate expenditures under the HH PPS during CY 2020 are equal
to the estimated aggregate expenditures that otherwise would have been made under the HH PPS
during CY 2020 in the absence of the change to a 30-day unit of service. Section
1895(b)(3)(A)(iv) of the Act requires that the calculation of the standard prospective payment
amount (or amounts) for CY 2020 be made before the application of the annual update to the
standard prospective payment amount as required by section 1895(b)(3)(B) of the Act.
Additionally, section 1895(b)(3)(A)(iv) of the Act requires that in calculating the
standard prospective payment amount (or amounts), the Secretary must make assumptions about
behavior changes that could occur as a result of the implementation of the 30-day unit of service
under section 1895(b)(2)(B) of the Act and case-mix adjustment factors established under section
1895(b)(4)(B) of the Act. Section 1895(b)(3)(A)(iv) of the Act further requires the Secretary to
provide a description of the behavior assumptions made in notice and comment rulemaking.
CMS finalized these behavior assumptions in the CY 2019 HH PPS final rule with comment
period (83 FR 56461).
Section 51001(a)(2)(B) of the BBA of 2018 also added a new subparagraph (D) to
section 1895(b)(3) of the Act. Section 1895(b)(3)(D)(i) of the Act requires the Secretary
annually to determine the impact of differences between assumed behavior changes, as described
in section 1895(b)(3)(A)(iv) of the Act, and actual behavior changes on estimated aggregate
expenditures under the HH PPS with respect to years beginning with 2020 and ending with 2026.
Section 1895(b)(3)(D)(ii) of the Act requires the Secretary, at a time and in a manner determined
appropriate, through notice and comment rulemaking, to provide for one or more permanent
increases or decreases to the standard prospective payment amount (or amounts) for applicable
years, on a prospective basis, to offset for such increases or decreases in estimated aggregate
expenditures, as determined under section 1895(b)(3)(D)(i) of the Act. Additionally, section

1895(b)(3)(D)(iii) of the Act requires the Secretary, at a time and in a manner determined
appropriate, through notice and comment rulemaking, to provide for one or more temporary
increases or decreases to the payment amount for a unit of home health services for applicable
years, on a prospective basis, to offset for such increases or decreases in estimated aggregate
expenditures, as determined under section 1895(b)(3)(D)(i) of the Act. Such a temporary
increase or decrease shall apply only with respect to the year for which such temporary increase
or decrease is made, and the Secretary shall not take into account such a temporary increase or
decrease in computing the payment amount for a unit of home health services for a subsequent
year. Finally, section 51001(a)(3) of the BBA of 2018 amends section 1895(b)(4)(B) of the Act
by adding a new clause (ii) to require the Secretary to eliminate the use of therapy thresholds in
the case-mix system for CY 2020 and subsequent years.
Division FF, section 4136 of the Consolidated Appropriations Act, 2023 (CAA, 2023)
(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-guidanceguidancetransmittals2020transmittals/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).

FIGURE 1: CASE-MIX VARIABLES IN THE PDGM

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 60dayepisodes, 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 30day 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 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.
TABLE 2: OVERALL UTILIZATION OF HOME HEALTH SERVICES,
CYs 2018-2023
Volume of Periods and Number of Beneficiaries
30-Day Periods of Care
Unique Beneficiaries
Average Number of 30-Day Periods per Unique Beneficiary

CY 2018
(Simulated)
9,336,898
2 980,385
3.13

CY 2019
(Simulated)
8,744,171
2 802,560
3.12

CY 2020
8,423,688
2,850,916
2.95

CY 2021
9,269,971
3,017,464
3.07

CY 2022
8,593,266
2,831,138
3.04

Source: CY 2018 and CY 2019 simulated PDGM data with behavioral assumptions came from the Home Health LDS. CY 2020 data was
accessed from the Chronic Conditions Warehouse (CCW) Virtual Research Data Center (VRDC) on July 12, 2021. CY 2021 data was accessed
from the CCW VRDC on July 14, 2022. CY 2022 data was accessed from the CCW VRDC on July 13, 2023. CY 2023 data was accessed from
the CCW VRDC on March 19, 2024.
Note: All 30-day periods of care claims were included (for example LUPAs, partial episode payments (PEPs), and outliers).

TABLE 3: UTILIZATION OF VISITS PER 30-DAY PERIODS OF CARE BY HOME
HEALTH DISCIPLINE, CYs 2018-2023

CY 2023
8,133,377
2,668,884
3.05

Discipline
Skilled Nursing
Physical Therapy
Occupational Therapy
Speech Therapy
Home Health Aide
Social Worker
Total (all disciplines)

CY 2018
(Simulated)
4.53
3.30
1.02
0.21
0.72
0.08
9.86

CY 2019
(Simulated)
4.49
3.33
1.07
0.21
0.67
0.08
9.85

CY 2020
4.35
2.70
0.79
0.16
0.54
0.06
8.59

CY 2021
4.05
2.74
0.78
0.15
0.48
0.05
8.25

CY 2022
3.90
2.77
0.77
0.14
0.43
0.05
8.06

CY 2023
3.86
2.78
0.76
0.14
0.41
0.05
8.00

Source: CY 2018 and CY 2019 simulated PDGM data with behavior assumptions came from the Home Health
LDS. CY 2020 data was accessed from the Chronic Conditions Warehouse (CCW) Virtual Research Data Center
(VRDC) on July 12, 2021. CY 2021 data was accessed from the CCW VRDC on July 14, 2022. CY 2022 data was
accessed from the CCW VRDC on July 13, 2023. CY 2023 data was accessed from the CCW VRDC on March 19,
2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers). There are
approximately 540,000 60-day episodes that started in 2019 and ended in 2020 that are not included in the analysis.

TABLE 4: THE PROPORTION OF 30-DAY PERIODS OF CARE THAT ARE LUPAs
AND THE AVERAGE NUMBER OF VISITS BY HOME HEALTH DISCIPLINE
FOR LUPA HOME HEALTH PERIODS, CYs 2018-2023
CY 2018
(Simulated)
Total LUPA % of Overall 30-day Periods
6.7%
Discipline (Average # visits for LUPA home health periods)
Skilled Nursing
1.15
Physical Therapy
0.43
Occupational Therapy
0.07
Speech Therapy
0.02
Home Health Aide
0.01
Social Worker
0.01
Total
1.69

CY 2019
(Simulated)
6.8%

CY
2020
8.7%

CY
2021
7.9%

CY
2022
7.8%

CY
2023
6.8%

1.14
0.46
0.07
0.02
0.01
0.01
1.71

1.19
0.53
0.08
0.02
0.01
0.01
1.84

1.12
0.55
0.08
0.02
0.01
0.01
1.79

1.08
0.60
0.09
0.02
0.01
0.01
1.81

0.99
0.51
0.07
0.02
0.01
0.01
1.61

Source: CY 2018 and CY 2019 simulated PDGM data with behavioral assumptions came from the Home Health
LDS. CY 2020 data was accessed from the Chronic Conditions Warehouse (CCW) Virtual Research Data Center
(VRDC) on July 12, 2021. CY 2021 data was accessed from the CCW VRDC on July 14, 2022. CY 2022 data was
accessed from the CCW VRDC on July 13, 2023. CY 2023 data was accessed from the CCW VRDC on March 19,
2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers). There are
approximately 540,000 60-day episodes that started in 2019 and ended in 2020 that are not included in the analysis.

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.
TABLE 5: ESTIMATED AVERAGE COSTS FOR 30-DAY PERIODS OF CARE
IN CY 2023
2022
Average
Costs per
visit with
NRS
$176.50
$176.71
$172.48
$200.12
$302.77
$95.94

Discipline
Skilled Nursing
Physical Therapy
Occupational Therapy
Speech Pathology
Medical Social Services
Home Health Aides
Total

2023
Market
Basket
Update
Factor
1.04
1.04
1.04
1.04
1.04
1.04

2023
2023
Average
Estimated 30Number of
Day Period
Visits
Costs
4.08
$748.92
2.95
$542.15
0.81
$145.30
0.15
$31.22
0.05
$15.74
0.44
$43.90
$1,527.23

Source: 2022 Medicare cost report data obtained on February 1, 2024. Home health visit information came from
30-day periods with a through date in CY2023 (Obtained from the CCW VRDC on March 19, 2024).

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

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).

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.
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.
TABLE 6: DISTRIBUTION OF 30-DAY PERIODS OF CARE BY THE 12 PDGM
CLINICAL GROUPS, CYs 2018-2023
Clinical Grouping
Behavioral Health
Complex Nursing
MMTA – Cardiac
MMTA – Endocrine
MMTA – GI/GU
MMTA – Infectious
MMTA – Other
MMTA – Respiratory
MMTA – Surgical Aftercare
MS Rehab
Neuro Rehab
Wounds

CY 2018
(Simulated)
1.7%
2.6%
16.5%
17.3%
2.2%
2.9%
4.7%
4.3%
1.8%
17.1%
14.4%
14.5%

CY 2019
(Simulated)
1.5%
2.5%
16.1%
17.4%
2.3%
2.7%
4.7%
4.1%
1.8%
17.3%
14.5%
15.1%

CY 2020
2.3%
3.5%
18.9%
7.2%
4.7%
4.8%
3.1%
7.8%
3.6%
19.4%
10.5%
14.2%

CY 2021
2.4%
3.3%
18.5%
6.9%
4.7%
4.6%
3.6%
8.0%
3.4%
19.8%
10.9%
13.9%

CY 2022
2.3%
3.2%
17.9%
6.8%
4.9%
4.6%
3.5%
7.8%
3.4%
20.8%
11.0%
13.7%

CY 2023
2.2%
3.1%
17.5%
7.0%
5.0%
4.7%
3.7%
7.2%
3.5%
21.2%
10.9%
14.0%

Source: CY 2018 and CY 2019 simulated PDGM data with behavioral assumptions came from the Home Health LDS. Analysis
of PDGM claims data for CY 2020 through CY 2023. CY 2020 data was accessed from the Chronic Conditions Warehouse
(CCW) Virtual Research Data Center (VRDC) on July 12, 2021. CY 2021 data was accessed from the CCW VRDC on July 14,
2022. CY 2022 data was accessed from the CCW VRDC on July 13, 2023. CY 2023 data was accessed from the CCW VRDC on
March 19, 2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers). The average case mix weight
for each clinical group includes all 30-day periods regardless of other adjustments (for example admission source, timing,
comorbidities, etc.).

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.
TABLE 7: DISTRIBUTION OF 30-DAY PERIODS OF CARE BY COMORBIDITY
ADJUSTMENT CATEGORY FOR 30-DAY PERIODS, CYs 2018-2023
Comorbidity
Adjustment
None
Low
High

CY 2018
CY 2019
(Simulated) (Simulated)
55.6%
52.0%
35.3%
38.0%
9.2%
10.0%

CY 2020
49.1%
36.9%
14.0%

CY 2021

CY 2022

CY 2023

49.6%
36.9%
13.5%

37.3%
47.8%
14.9%

30.7%
52.6%
16.7%

Source: CY 2018 and CY 2019 simulated PDGM data with behavioral assumptions came from the Home Health LDS. CY 2020
data was accessed from the Chronic Conditions Warehouse (CCW) Virtual Research Data Center (VRDC) on July 12, 2021. CY
2021 data was accessed from the CCW VRDC on July 14, 2022. CY 2022 data was accessed from the CCW VRDC on July 13,
2023. CY 2023 data was accessed from the CCW VRDC on March 19, 2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers). There are approximately
540,000 60-day episodes that started in 2019 and ended in 2020 that are not included in the analysis.

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.
TABLE 8: DISTRIBUTION OF 30-DAY PERIODS OF CARE BY ADMISSION
SOURCE AND PERIOD TIMING, CYs 2018-2023
Admission
Source
Community
Community
Institutional
Institutional

Period
Timing
Early
Late
Early
Late

CY 2018
CY 2019
(Simulated) (Simulated)
13.5%
13.8%
61.1%
60.9%
18.6%
18.4%
6.8%
6.9%

CY 2020
12.4%
61.8%
20.0%
5.8%

CY 2021
11.6%
63.7%
18.6%
6.1%

CY 2022 CY 2023
11.7%
11.7%
63.1%
63.2%
19.2%
19.2%
6.0%
6.0%

Source: CY 2018 and CY 2019 simulated PDGM data with behavioral assumptions came from the Home Health
LDS. CY 2020 data was accessed from the Chronic Conditions Warehouse (CCW) Virtual Research Data Center
(VRDC) on July 12, 2021. CY 2021 data was accessed from the CCW VRDC on July 14, 2022. CY 2022 data was
accessed from the CCW VRDC on July 13, 2023. CY 2023 data was accessed from the CCW VRDC on March 19,
2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers). There are
approximately 540,000 60-day episodes that started in 2019 and ended in 2020 that are not included in the analysis.

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 webpage.3 The sum of these points results in a functional
impairment score used to group 30-day periods of care into a functional impairment level with
similar resource use. The scores associated with the functional impairment levels vary by clinical

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.
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.
TABLE 9: DISTRIBUTION OF 30-DAY PERIODS OF CARE BY FUNCTIONAL
IMPAIRMENT LEVEL, CYs 2018-2023
Functional Impairment Level
Low
Medium
High

CY 2018
CY 2019
(Simulated) (Simulated)
33.9%
31.9%
34.9%
35.5%
31.2%
32.6%

CY 2020
25.7%
32.7%
41.7%

CY
CY
CY
2021
2022
2023
23.2% 28.1% 29.8%
32.6% 33.1% 31.8%
44.2% 38.8% 38.3%

Source: CY 2018 and CY 2019 simulated PDGM data with behavioral assumptions came from the Home Health
LDS. CY 2020 PDGM data was accessed from the CCW VRDC on July 12, 2021. CY 2021 PDGM data was
accessed from the CCW VRDC on July 14, 2022. CY 2022 PDGM data was accessed from the CCW VRDC on
January 20, 2023. CY 2023 data was accessed from the CCW VRDC on March 19, 2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers). There are
approximately 540,000 60-day episodes that started in 2019 and ended in 2020 that are not included in the analysis.

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-

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).
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.
TABLE 10: PROPORTION OF 30-DAY PERIODS OF CARE WITH ONLY THERAPY,
AT LEAST ONE THERAPY VISIT, AND NO THERAPY VISITS FOR CYs 2018-2023
30-day Period Visit
Type
Therapy Only
Therapy + Non-Therapy
No Therapy
Total 30-day periods

CY 2018
(Simulated)
13.5%
48.2%
38.3%
9,336,898

CY 2019
(Simulated)
14.4%
48.4%
37.2%
8,744,171

CY 2020

CY 2021

CY 2022

CY 2023

15.2%
42.2%
42.6%
8,423,688

17.8%
42.3%
39.9%
8,962,690

19.3%
42.7%
38.0%
8,593,266

20.1%
42.8%
37.1%
8,133,377

Source: CY 2018 and CY 2019 simulated PDGM data with behavioral assumptions came from the Home Health LDS. CY 2020 PDGM data
was accessed from the CCW VRDC on July 12, 2021. CY 2021 PDGM data was accessed from the CCW VRDC on July 14, 2022. CY 2022
PDGM data was accessed from the CCW VRDC on January 20, 2023. CY 2023 data was accessed from the CCW VRDC on March 19, 2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers). There are approximately 540,000 60-day
episodes that started in 2019 and ended in 2020 that are not included in the analysis.

FIGURE 2: PROPORTION OF 30-DAY PERIODS OF CARE BY THE NUMBER
OF THERAPY VISITS DURING 30-DAY PERIODS, CYs 2018-2023

Figure 2: Proportion of 30-day Periods by the Number of Therapy
Visits During 30-day Periods, CY 2020-2023
CY2018 (Simulated)

CY2019 (Simulated)

2021

2023

9.0%

Percent of 30-day Periods

8.0%
7.0%
6.0%
5.0%
4.0%
3.0%
2.0%
1.0%
0.0%

2

4

6

8

10

12

13+

Number of Therapy Visits During 30-day Periods
Source: CY 2018 and CY 2019 simulated PDGM data with behavioral assumptions came from the Home Health
LDS. CY 2020 PDGM data was accessed from the CCW VRDC on July 12, 2021. CY 2021 PDGM data was
accessed from the CCW VRDC on July 14, 2022. CY 2022 PDGM data was accessed from the CCW VRDC on
January 20, 2023. CY 2023 data was accessed from the CCW VRDC on March 19, 2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers). There are
approximately 540,000 60-day episodes that started in 2019 and ended in 2020 that are not included in the analysis.
Thirty-day periods with ≥13 therapy visits were combined into one category for illustrative purposes only.

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.

TABLE 11: AVERAGE THERAPY VISITS PER 30-DAY PERIOD BY
CLINICALGROUP, CYs 2018-2023
2019

2021

2023

8.0

# Therapy Visits

7.0
6.0
5.0
4.0
3.0
2.0
1.0
0.0

MMTA
MMTA
MMTA MMTA
Behave Complex MMTA
MMTA
MMTA
MS Neuro
Wounds
Endocri
Infectio
Respira Surgica
Health Nursing Cardiac
GI/GU
Other
Rehab Rehab
ne
us
tory
l
4.4
2.2
4.0
3.6
4.1
3.5
4.7
4.3
3.9
6.6
7.0
2.4
2018
4.4
2.2
4.1
3.6
4.1
3.7
4.8
4.4
4.0
6.7
7.0
2.4
2019
3.1

1.2

3.0

2.5

3.3

2.9

3.8

3.6

3.4

5.8

5.8

1.9

3.2

1.1

3.0

2.4

3.3

3.0

3.9

3.8

3.4

5.6

5.6

1.8

3.3

1.1

3.1

2.4

3.3

3.1

3.9

3.9

3.4

5.5

5.5

1.8

3.3

1.1

3.1

2.4

3.4

3.1

3.9

3.9

3.4

5.5

5.4

1.9

Source: CY 2018 and CY 2019 simulated PDGM data with behavioral assumptions came from the Home Health
LDS. CY 2020 data was accessed from the Chronic Conditions Warehouse (CCW) Virtual Research Data Center
(VRDC) on July 12, 2021. CY 2021 data was accessed from the CCW VRDC on July 14, 2022. CY 2022 data was
accessed from the CCW VRDC on July 13, 2023. CY 2023 data was accessed from the CCW VRDC on March 19,
2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers).

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.
TABLE 12: PROPORTION OF 30-DAY PERIODS OF CARE WITH ONLY
SKILLED NURSING, SKILLED NURSING + OTHER VISIT TYPE, AND NO SKILLED
NURSING VISITS FOR CYs 2018-2023
30-day Period Visit Type

CY 2018
(Simulated)

CY 2019
(Simulated)

CY 2020

CY 2021

CY 2022

CY 2023

Skilled Nursing Only
Skilled Nursing + Other
No Skilled Nursing
Total 30-day periods

33.8%
51.6%
14.7%
9,336,898

33.1%
51.5%
15.5%
8,744,171

38.5%
45.3%
16.2%
8,423,688

36.2%
44.9%
18.9%
8,962,690

34.7%
45.0%
20.4%
8,593,266

34.1%
44.7%
21.2%
8,133,377

Source: CY 2018 and CY 2019 simulated PDGM data with behavioral assumptions came from the Home Health LDS. CY 2020 PDGM data
was accessed from the CCW VRDC on July 12, 2021. CY 2021 PDGM data was accessed from the CCW VRDC on July 14, 2022. CY 2022
PDGM data was accessed from the CCW VRDC on January 20, 2023. CY 2023 data was accessed from the CCW VRDC on March 19, 2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers). There are approximately 540,000 60-day
episodes that started in 2019 and ended in 2020 that are not included in the analysis.

TABLE 13: PROPORTION OF 30-DAY PERIODS OF CARE WITH AND
WITHOUT HOME HEALTH AIDE AND/OR SOCIAL WORKER VISITS FOR CYs
2018-2023
30-day Period Visit Type
Any HH aide and/or social worker
No HH aide and/or social worker
Total 30-day periods

CY 2018
(Simulated)
16.6%
83.4%
9,336,898

CY 2019
(Simulated)
15.9%
84.1%
8,744,171

CY 2020
13.2%
86.8%
8,423,688

CY 2021
12.2%
87.8%
8,962,690

CY 2022
11.3%
88.7%
8,593,266

CY 2023
10.8%
89.2%
8,133,377

Source: CY 2018 and CY 2019 simulated PDGM data with behavioral assumptions came from the Home Health LDS. CY 2020 data was
accessed from the Chronic Conditions Warehouse (CCW) Virtual Research Data Center (VRDC) on July 12, 2021. CY 2021 data was accessed
from the CCW VRDC on July 14, 2022. CY 2022 data was accessed from the CCW VRDC on July 13, 2023. CY 2023 data was accessed from
the CCW VRDC on March 19, 2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers). There are approximately 540,000 60-day
episodes that started in 2019 and ended in 2020 that are not included in the analysis.

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.
TABLE 14: UTILIZATION OF TELECOMMUNICATIONS TECHNOLOGY
PER 30-DAY PERIODS OF CARE BY HOME HEALTH DISCIPLINE AS INDICATED
BY G0320/G0321, CY 2023

Claims with at Least
1 Service Using
Telecommunication

Skilled Nursing
PT
OT
SLP
Aide
MSS

Number of Services
Using
Telecommunication

63,049
13,412
2,761
740
5
1,812

128,566
21,614
3,996
1,176
6
2,052

Unique Beneficiaries
with at Least 1 Service
Using
Telecommunication

Unique Providers
with at Least 1
Service Using
Telecommunicatio
n

48,450
11,167
2,336
558
5
1,691

1,221
523
262
107
1
Source: CY 2023 data was accessed from the CCW VRDC on March 19, 2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers).

TABLE 15: UTILIZATION OF REMOTE MONITORING PER 30-DAY
PERIODS OF CARE BY HOME HEALTH DISCIPLINE AS INDICATED BY G0322, CY
Skilled Nursing
PT
OT
SLP
Aide

Claims with at
Least 1 Day of
Remote
Patient
Monitoring
19,084
380
20
53
Number of
Remote
Patient
Monitoring
Days
337,194
6,072
188
966
Unique
Unique
Providers with
Beneficiaries with
at Least 1 Day
at Least 1 Day of
of Remote
Remote Patient
Patient
Monitoring
Monitoring
11,615
494
296
82
20
15
41
7
6
MSS

4,480

2

Source: CY 2023 data was accessed from the CCW VRDC on March 19, 2024.
Note: All 30-day periods of care claims were included (for example LUPAs, PEPs, and outliers).

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 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 budgetneutral 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, 60Day 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
webpage at https://www.cms.gov/medicare/medicare-fee-for-servicepayment/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 30day 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.
FIGURE 3: ITEMS ASKED ON SOC/ROC AND NOT FOLLOW-UP ON OASIS-E
SOC/ROC
M1311. Current Number of Unhealed Pressure Ulcers/Injuries at Each Stage
M1322. Current Number of Stage 1 Pressure Injuries
Intact skin with non-blanchable redness of a localized area usually over a bony prominence.
Darkly pigmented skin may not have a visible blanching; in dark skin tones only, it may
appear with persistent blue or purple hues.
M1324. Stage of Most Problematic Unhealed Pressure Ulcer/Injury that is Stageable
Excludes pressure ulcer/injury that cannot be staged due to a non-removable dressing/device,
coverage of wound bed by slough and/or eschar, or deep tissue injury
M1330. Does this patient have a Stasis Ulcer?
M1332. Current Number of Stasis Ulcer(s) that are Observable
M1334. Status of Most Problematic Stasis Ulcer that is Observable
M1340. Does this patient have a Surgical Wound?
M1342. Status of Most Problematic Surgical Wound that is Observable
M1400. When is the patient dyspneic or noticeably Short of Breath?
M1610. Urinary Incontinence or Urinary Catheter Presence
M1620.Bowel Incontinence Frequency
M1630. Ostomy for Bowel Elimination
Does this patient have an ostomy for bowel elimination that (within the last 14 days): a) was
related to an inpatient facility stay; or b) necessitated a change in medical or treatment
regimen?
M2030. Management of Injectable Medications
Patient’s current ability to prepare and take all prescribed injectable medications reliably and
safely, including administration of correct dosage at the appropriate time/intervals. Excludes
IV medications.
Note: We only show the assessment prompt for these 13 items. Each item listed has associated responses which can
be found in the OASIS Manual located at https://www.cms.gov/medicare/quality/home-health/oasis-user-manuals.

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.
FIGURE 4: OASIS-D ITEMS THAT DIFFER FROM OASIS-E

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 60day 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.
FIGURE 5: THERAPIES MAPPING FROM OASIS-E TO OASIS-D
OASIS-E Item: O0110H -IV
Medication

OASIS-D Item: M1030 – IV or
Infusion Therapy

Response: No

Response: No

Response: Yes

Response: Yes

Response: Missing

Response: None of the above

OASIS-E Item: K0520 –
Parenteral/IV Feeding

OASIS-D Item: M1030 –
Parenteral Nutrition

Response: No

Response: No

Response: Yes

Response: Yes

Response: Missing

Response: None of the above

OASIS-E Item: K0520 – Feeding
Tube

OASIS-D Item: M1030 – Enteral
Nutrition

Response: No

Response: No

Response: Yes

Response: Yes

Response: Missing

Response: None of the above

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”.
FIGURE 6: VISION MAPPING FROM OASIS-E TO OASIS-D
OASIS-E Item: B1000 – Vision

OASIS-D Item: M1200 – Vision

Response: Adequate

Response: Normal

Response: Impaired
Response: Moderately Impaired

Response: Partially Impaired

Response: Highly Impaired
Response: Severely Impaired

Response: Severely Impaired

Response: Missing

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.
FIGURE 7: PAIN MAPPING FROM OASIS-E to OASIS-D
OASIS-E Item: Max of J0510,
J0520, and J0530

OASIS-D Item: M1242
Frequency of Pain

Max Response: No pain

Response: No pain

Max Response: Rarely or not at all

Response: Does not interfere

Max Response: Occasionally

Response: Less often than daily

Max Response: Frequently

Response: Daily, not constantly

Max Response: Almost constantly

Response: All of the time

Unable to answer

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 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 webpage 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 webpage6, 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.

5 https://www.cms.gov/research-statistics-data-and-systems/files-for-order/limiteddatasets/home_health_pps_lds.

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-ProspectivePayment-System-Regulations-and-Notices.
e. Applying the Methodology to CY 2023 Data to Determine the CY 2025 Permanent and
Temporary Adjustments
Using the methodology finalized in the CY 2023 HH PPS final rule 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 30day 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.
TABLE 16: CY 2023 PROPOSED PERMANENT AND TEMPORARY
ADJUSTMENT CALCULATIONS

Base Payment
Rate

Budget-neutral 30-day
Payment Rate with
Assumed Behavior Changes

Budget-neutral 30-day
Payment Rate with
Actual Behavior Changes

$1,894.49*

$1,873.17

CY 2023 Only
Adjustment
Permanent
-1.125%

Aggregate
Expenditures

$15,982,282,880*

$15,016,399,156

Temporary
-$965,883,723

Source: CY 2023 Home Health Claims Data, Periods that end in CY 2023 accessed on the CCW March 19, 2024
Notes: *The $1,894.49 is equal to the recalculated budget neutral 30-day base payment rate of $1,839.10 for CY
2022 (shown in table 16) multiplied by the CY 2023 recalibration factor (0.9904), wage index budget neutrality
factor (1.0001) and the CY 2023 home health payment update (1.040).
**The estimated aggregate expenditures for assumed behavior ($16 billion), uses the actual CY 2023 payment rate of
$2,010.69 as this is what CMS actually paid in CY 2023.

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:
($1,873.17 ― $1,894.49)
= ―1.125 %
$1,894.49
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.
TABLE 17: TOTAL PERMANENT ADJUSTMENT
FOR CYs 2020, 2021, 2022, and 2023
Actual CY 2023 Base
Payment Rate
(Assumed Behavior)
$2,010.69

Recalculated CY 2023 Base
Payment Rate
(Actual Behavior)
$1,873.17

Total Permanent
Prospective Adjustment
-6.839%*

Source: CY 2023 Home Health Claims Data, Periods that end in CY 2023 accessed on the CCW March 19, 2024.
*This is the total permanent adjustment based on CY 2023 data which includes the previous permanent adjustment
of -3.925% applied. However, as described later, we recognize for CY 2025 we must account for adjustment made
in CY 2024.

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:
($1,873.17 ― $2,010.69)
= ―6.839 %
$2,010.69
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) × (1 ― 𝑥) = (1 ― 0.06839). To illustrate this calculation we used the following
approach.
1 0.06839

𝑥=1―
1 0.0289
𝑥 = 1 ― 0.95933
𝑥 = 0.04067

We are required by law7 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.
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)

7 Sections

1895(b)(3)(D)(i) and 1895(b)(3)(D)(ii) of the Act.

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.
TABLE 18: SUMMARY OF PERMANENT ADJUSTMENTS
FOR CYS 2020 – 2026

Claims Analysis
Year
CY 2020

Base Payment
Rate for Assumed
Behaviors (Actual
Amount Paid to
HHAs in the
Claims Analysis
Year)
$1,864.03

Base Payment
Rate that Reflects
Actual Behavior
Changes (As
Determined After
Later Claims
Analysis)
$1,742.52

Total Permanent
Adjustment
Between Assumed
and Actual
Behavior Rates*
-6.52%

CY 2021

$1,901.12

$1,751.90

-7.85%

CY 2022

$2,031.64

$1,839.10

CY 2023
CY 2024
CY 2025
CY 2026

$2,010.69
$2,038.13
TBD
TBD

$1,873.17
TBD
TBD
TBD

-5.78%
Proposed
-4.067%
TBD
TBD
TBD

Permanent Adjustment
CMS Finalized and
Implemented in
Rulemaking
n/a
-3.925% applied to
CY 2023 rates
-2.890% applied to
CY 2024 rates
-4.067% proposed to be
applied to CY 2025 rates
TBD
TBD
TBD

Notes: With the prospective payment systems, the claims data analyzed differ from the rulemaking cycle. For example, CY 2020
claims are used in CY 2022 rulemaking.
*The total permanent adjustment accounts for prior adjustments that were finalized and implemented through rulemaking.

TABLE 19: SUMMARY OF ANTICIPATED TEMPORARY ADJUSTMENTS
CALCULATED FOR CYs 2020 – 2026
Claims Analysis Year

CY 2020
CY 2021
CY 2022
CY 2023 (as of proposed rule)
CY 2024

Dollar Amount
-$873,073,121
-$1,211,002,953
-$1,405,447,290
-$965,883,723
TBD

CY 2025
CY 2026
Total

TBD
TBD
-$4,455,407,087
Source: CY 2020 Home Health Claims Data, Periods that begin and end in CY 2020 accessed on the CCW
July 12, 2021. CY 2021 Home Health Claims Data, Periods that end in CY 2021 accessed on the CCW July
15, 2022. CY 2022 Home Health Claims Data, Periods that end in CY 2022 accessed on CCW July 15,
2023. CY 2023 Home Health Claims Data, Periods that end in CY 2023 accessed on CCW March 19,
2024.
Note: The anticipated temporary adjustments of approximately $4.5 billion would require temporary
adjustment(s) to offset for such increases in estimated aggregate expenditures. The dollar amount would be
converted to a factor when implemented in future rulemaking.

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 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 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
webpage 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.
TABLE 20: PROPOSED OASIS POINTS TABLE FOR CY 2025

M1800: Grooming
M1810: Current Ability to Dress Upper Body
M1820: Current Ability to Dress Lower Body

Responses
0 or 1
2 or 3
0 or 1
2 or 3
0 or 1
Points
(2023)
0
3
0
5
0
Percent of
Periods in
2023 with this
Response
Category
25.4%
74.6%
19.5%
80.5%
9.3%
65.3%

M1830: Bathing
M1840: Toilet Transferring
M1850: Transferring

M1860: Ambulation/Locomotion

M1033: Risk of Hospitalization

3
0 or 1
2
3 or 4
5 or 6
0 or 1
2, 3 or 4
0
1
2, 3, 4 or 5
0 or 1
2
3
4, 5 or 6
Three or fewer items
marked (Excluding
responses 8, 9 or 10)
Four or more items
marked (Excluding
responses 8, 9 or 10)

11
0
3
10
18
0
5
0
1
4
0
6
2
25.4%
2.3%
10.0%
49.6%
38.0%
61.0%
39.0%
1.2%
18.8%
80.0%
3.1%
13.8%
65.2%
17.8%

58.9%

41.1%

Source: CY 2023 Home Health Claims Data, Periods that end in CY 2023 accessed from the CCW on March 19, 2024.
Note: For item M1860, the point values for response 2 is worth more than the point values for response 3. There may be times
in which the resource use for certain OASIS items associated with functional impairment will result in a seemingly inverse
relationship to the response reported. However, this is the result of the direct association between the responses reported on the
OASIS items and actual resource use.

TABLE 21: PROPOSED THRESHOLDS FOR FUNCTIONAL LEVELS BY CLINICAL
GROUP, FOR CY 2025
Clinical Group
MMTA – Other
Behavioral Health
Complex Nursing Interventions
Musculoskeletal Rehabilitation
Neuro Rehabilitation
Wound
MMTA - Surgical Aftercare
MMTA - Cardiac and Circulatory

Level of
Impairment
Low
Medium
High
Low
Medium
High
Low
Medium
High
Low
Medium
High
Low
Medium
High
Low
Medium
High
Low
Medium
High
Low
Medium
High

Points
(2023)
0-28
29-43
44+
0-28
29-44
45+
0-29
30-52
53+
0-29
30-43
44+
0-33
34-49
50+
0-32
33-48
49+
0-27
28-40
41+
0-27
28-40
41+

MMTA – Endocrine
MMTA - Gastrointestinal tract and
Genitourinary system
MMTA - Infectious Disease, Neoplasms, and
Blood-Forming Diseases
MMTA – Respiratory

Low
Medium
High
Low
Medium
High
Low
Medium
High
Low
Medium
High

0-27
28-40
41+
0-32
33-47
48+
0-31
32-44
45+
0-32
33-44
45+

Source: CY 2023 Home Health Claims Data, Periods that end in CY 2023 accessed from the CCW on
March 19, 2024.

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 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
webpage 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.
TABLE 22: LOW COMORBIDITY ADJUSTMENT SUBGROUPS FOR CY 2025
Low Comorbidity Subgroup
Cerebral 4
Circulatory 10
Circulatory 2
Circulatory 9
Endocrine 3
Endocrine 4
Gastrointestinal 2
Heart 10
Heart 11
Neoplasms 1
Neoplasms 17
Neoplasms 18
Neoplasms 2
Neoplasms 20
Neurological 10
Neurological 11
Neurological 12
Neurological 5
Neurological 7
Skin 1
Skin 3
Skin 4

Description
Sequelae of Cerebrovascular Diseases, includes Cerebral Atherosclerosis and Stroke Sequelae
Varicose Veins and Lymphedema
Hemolytic, Aplastic, and Other Anemias
Other Venous Embolism and Thrombosis
Type 1, Type 2, and Other Specified Diabetes
Other Combined Immunodeficiencies and Malnutrition, includes graft-versus-host-disease
Intestinal Obstruction and Ileus
Dysrhythmias, includes Atrial Fibrillation and Atrial Flutter
Heart Failure
Malignant Neoplasms of Lip, Oral Cavity and Pharynx, includes Head and Neck Cancers
Secondary neoplasms of respiratory and GI systems.
Secondary Neoplasms of Urinary and Reproductive Systems, Skin, Brain, and Bone
Malignant Neoplasms of Digestive Organs, includes Gastrointestinal Cancers
Non-Hodgkin’s Lymphoma
Diabetes with neuropathy
Disease of the Macula and Blindness/Low Vision
Nondiabetic neuropathy
Spinal Muscular Atrophy, Systemic atrophy and Motor Neuron Disease
Paraplegia, Hemiplegia and Quadriplegia
Cutaneous Abscess, Cellulitis, and Lymphangitis
Diseases of arteries, arterioles and capillaries with ulceration and non-pressure chronic ulcers
Stages Two-Four and unstageable pressure ulcers by site

Source: CY 2023 Home Health Claims Data, Periods that end in CY 2022 accessed on the CCW March 19, 2024.

TABLE 23: HIGH COMORBIDITY ADJUSTMENT INTERACTIONS FOR CY 2025
Comorbidity
Subgroup
Interaction

Comorbidity Group

Behavioral 2

Behavioral 2

Behavioral 2

Behavioral 2

Behavioral 4

Behavioral 4

Behavioral 5

Behavioral 5

Behavioral 5

Behavioral 5

Cerebral 4

Cerebral 4

Cerebral 4

Cerebral 4

Description
Mood Disorders, includes Depression and
Bipolar Disorder
Mood Disorders, includes Depression and
Bipolar Disorder
Mood Disorders, includes Depression and
Bipolar Disorder
Mood Disorders, includes Depression and
Bipolar Disorder
Psychotic, major depressive, and
dissociative disorders, includes unspecified
dementia, eating disorder and intellectual
disabilities
Psychotic, major depressive, and
dissociative disorders, includes unspecified
dementia, eating disorder and intellectual
disabilities
Phobias, Other Anxiety and Obsessive
Compulsive Disorders
Phobias, Other Anxiety and Obsessive
Compulsive Disorders
Phobias, Other Anxiety and Obsessive
Compulsive Disorders
Phobias, Other Anxiety and Obsessive
Compulsive Disorders
Sequelae of Cerebrovascular Diseases,
includes Cerebral Atherosclerosis and
Stroke Sequelae
Sequelae of Cerebrovascular Diseases,
includes Cerebral Atherosclerosis and
Stroke Sequelae
Sequelae of Cerebrovascular Diseases,
includes Cerebral Atherosclerosis and
Stroke Sequelae
Sequelae of Cerebrovascular Diseases,
includes Cerebral Atherosclerosis and
Stroke Sequelae

Comorbidity Group
Circulatory 10
Neurological 7
Skin 3
Skin 4

Description
Varicose Veins and Lymphedema
Paraplegia, Hemiplegia and
Quadriplegia
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Stages Two-Four and unstageable
pressure ulcers by site

Skin 3

Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers

Skin 4

Stages Two-Four and unstageable
pressure ulcers by site

Neurological 5
Neurological 7
Skin 1
Skin 3
Circulatory 7

Spinal Muscular Atrophy, Systemic
atrophy and Motor Neuron Disease
Paraplegia, Hemiplegia and
Quadriplegia
Cutaneous Abscess, Cellulitis, and
Lymphangitis
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Atherosclerosis, includes Peripheral
Vascular Disease, Aortic Aneurysms
and Hypotension

Circulatory 9

Other Venous Embolism and
Thrombosis

Endocrine 3

Type 1, Type 2, and Other Specified
Diabetes

Heart 10

Dysrhythmias, includes Atrial
Fibrillation and Atrial Flutter

Comorbidity
Subgroup
Interaction

Comorbidity Group

Description
Sequelae of Cerebrovascular Diseases,
includes Cerebral Atherosclerosis and
Stroke Sequelae
Sequelae of Cerebrovascular Diseases,
includes Cerebral Atherosclerosis and
Stroke Sequelae
Sequelae of Cerebrovascular Diseases,
includes Cerebral Atherosclerosis and
Stroke Sequelae
Sequelae of Cerebrovascular Diseases,
includes Cerebral Atherosclerosis and
Stroke Sequelae
Sequelae of Cerebrovascular Diseases,
includes Cerebral Atherosclerosis and
Stroke Sequelae
Nutritional, Enzymatic, and Other
Heredity Anemias
Nutritional, Enzymatic, and Other
Heredity Anemias

Comorbidity Group

Description

Cerebral 4

Neurological 10

Diabetes with neuropathy

Cerebral 4

Neurological 12

Nondiabetic neuropathy

Cerebral 4

Respiratory 2

Whooping cough

Cerebral 4

Skin 3

Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers

Cerebral 4

Skin 4

Stages Two-Four and unstageable
pressure ulcers by site

Circulatory 1

Circulatory 1

Circulatory 1

Nutritional, Enzymatic, and Other
Heredity Anemias

Skin 3

Circulatory 10

Varicose Veins and Lymphedema

Circulatory 4

Circulatory 10

Varicose Veins and Lymphedema

Endocrine 1

Circulatory 10

Varicose Veins and Lymphedema

Endocrine 5

Circulatory 10

Varicose Veins and Lymphedema

Heart 11

Paraplegia, Hemiplegia and
Quadriplegia
Cutaneous Abscess, Cellulitis, and
Lymphangitis
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Hypertensive Chronic Kidney
Disease
Hypothyroidism
Obesity, and Disorders of Metabolism
and Fluid Balance
Heart Failure

Circulatory 10

Varicose Veins and Lymphedema

Heart 12

Other Heart Diseases

Circulatory 10

Varicose Veins and Lymphedema

Musculoskeletal 3

Circulatory 10

Varicose Veins and Lymphedema

Renal 3

Circulatory 10

Varicose Veins and Lymphedema

Skin 1

Circulatory 10

Varicose Veins and Lymphedema

Skin 3

Circulatory 2

Hemolytic, Aplastic, and Other Anemias

Gastrointestinal 2

Circulatory 2

Hemolytic, Aplastic, and Other Anemias

Neurological 7

Joint Pain
Other disorders of the kidney and
ureter, excluding chronic kidney
disease and ESRD
Cutaneous Abscess, Cellulitis, and
Lymphangitis
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Intestinal Obstruction and Ileus
Paraplegia, Hemiplegia and
Quadriplegia

Neurological 7
Skin 1

Comorbidity
Subgroup
Interaction

Comorbidity Group

Description

Comorbidity Group

Circulatory 4

Hypertensive Chronic Kidney Disease

Circulatory 9

Circulatory 4

Hypertensive Chronic Kidney Disease

Neurological 7

Circulatory 4

Hypertensive Chronic Kidney Disease

Skin 1

Circulatory 4

Hypertensive Chronic Kidney Disease

Skin 3

Circulatory 7

Circulatory 7

Circulatory 9

Other Venous Embolism and Thrombosis

Endocrine 4

Circulatory 9

Other Venous Embolism and Thrombosis

Renal 3

Endocrine 1

Hypothyroidism

Neoplasms 2

Endocrine 1

Hypothyroidism

Neurological 7

Endocrine 1

Hypothyroidism

Skin 3

Endocrine 3

Type 1, Type 2, and Other Specified
Diabetes

Endocrine 4

Endocrine 3

Type 1, Type 2, and Other Specified
Diabetes

Neurological 7

Endocrine 3

Type 1, Type 2, and Other Specified
Diabetes

Skin 3

Endocrine 4

Endocrine 4

Atherosclerosis, includes Peripheral
Vascular Disease, Aortic Aneurysms and
Hypotension
Atherosclerosis, includes Peripheral
Vascular Disease, Aortic Aneurysms and
Hypotension

Other Combined Immunodeficiencies and
Malnutrition, includes graft-versus-hostdisease
Other Combined Immunodeficiencies and
Malnutrition, includes graft-versus-hostdisease

Neurological 5
Skin 3

Description
Other Venous Embolism and
Thrombosis
Paraplegia, Hemiplegia and
Quadriplegia
Cutaneous Abscess, Cellulitis, and
Lymphangitis
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Spinal Muscular Atrophy, Systemic
atrophy and Motor Neuron Disease
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Other Combined Immunodeficiencies
and Malnutrition, includes graftversus-host-disease
Other disorders of the kidney and
ureter, excluding chronic kidney
disease and ESRD
Malignant Neoplasms of Digestive
Organs, includes Gastrointestinal
Cancers
Paraplegia, Hemiplegia and
Quadriplegia
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Other Combined Immunodeficiencies
and Malnutrition, includes graftversus-host-disease
Paraplegia, Hemiplegia and
Quadriplegia
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers

Neurological 5

Spinal Muscular Atrophy, Systemic
atrophy and Motor Neuron Disease

Neurological 7

Paraplegia, Hemiplegia and
Quadriplegia

Comorbidity
Subgroup
Interaction

Comorbidity Group

Description
Other Combined Immunodeficiencies and
Malnutrition, includes graft-versus-hostdisease
Other Combined Immunodeficiencies and
Malnutrition, includes graft-versus-hostdisease
Other Combined Immunodeficiencies and
Malnutrition, includes graft-versus-hostdisease
Obesity, and Disorders of Metabolism and
Fluid Balance
Obesity, and Disorders of Metabolism and
Fluid Balance

Comorbidity Group
Skin 1

Cutaneous Abscess, Cellulitis, and
Lymphangitis

Skin 3

Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers

Skin 4

Stages Two-Four and unstageable
pressure ulcers by site

Endocrine 4

Endocrine 4

Endocrine 4

Endocrine 5

Endocrine 5

Endocrine 5

Gastrointestinal 4

Heart 10

Heart 10

Dysrhythmias, includes Atrial Fibrillation
and Atrial Flutter

Skin 3

Heart 10

Dysrhythmias, includes Atrial Fibrillation
and Atrial Flutter

Skin 4

Heart 11

Heart Failure

Neoplasms 18

Heart 11

Heart Failure

Neurological 5

Heart 11

Heart Failure

Neurological 7

Heart 11

Heart Failure

Skin 3

Heart 11

Heart Failure

Skin 4

Heart 12

Other Heart Diseases

Neurological 7

Heart 12

Other Heart Diseases

Skin 3

Obesity, and Disorders of Metabolism and
Fluid Balance
Alcoholic Liver Disease, Chronic
Hepatitis, Fibrosis and Cirrhosis of the
Liver
Dysrhythmias, includes Atrial Fibrillation
and Atrial Flutter

Description

Neurological 5
Neurological 7
Skin 3
Skin 3
Neurological 7

Spinal Muscular Atrophy, Systemic
atrophy and Motor Neuron Disease
Paraplegia, Hemiplegia and
Quadriplegia
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Paraplegia, Hemiplegia and
Quadriplegia
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Stages Two-Four and unstageable
pressure ulcers by site
Secondary Neoplasms of Urinary and
Reproductive Systems, Skin, Brain,
and Bone
Spinal Muscular Atrophy, Systemic
atrophy and Motor Neuron Disease
Paraplegia, Hemiplegia and
Quadriplegia
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Stages Two-Four and unstageable
pressure ulcers by site
Paraplegia, Hemiplegia and
Quadriplegia
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers

Comorbidity
Subgroup
Interaction

Comorbidity Group

Description

Comorbidity Group

Heart 8

Other Pulmonary Heart Diseases

Skin 3

Heart 9

Valve Disorders

Skin 3

Infectious 1

C-diff, MRSA, E-coli

Neurological 7

Infectious 1

C-diff, MRSA, E-coli

Skin 3

Infectious 1

C-diff, MRSA, E-coli

Skin 4

Musculoskeletal 3

Joint Pain

Neurological 5

Musculoskeletal 3

Joint Pain

Skin 1

Musculoskeletal 3

Joint Pain

Skin 3

Musculoskeletal 4

Lumbar Spinal Stenosis

Skin 3

Neurological 10

Diabetes with neuropathy

Neurological 7

Neurological 10

Diabetes with neuropathy

Skin 1

Neurological 10

Diabetes with neuropathy

Skin 3

Neurological 10

Diabetes with neuropathy

Skin 4

Neurological 12

Nondiabetic neuropathy

Neurological 7

Neurological 12

Nondiabetic neuropathy

Skin 3

Neurological 4

Alzheimer’s disease and related dementias

Skin 4

Neurological 5

Neurological 7

Spinal Muscular Atrophy, Systemic
Atrophy, and Motor Neuron Disease
Paraplegia, Hemiplegia and Quadriplegia

Neurological 7
Neurological 8

Description
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Paraplegia, Hemiplegia and
Quadriplegia
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Stages Two-Four and unstageable
pressure ulcers by site
Spinal Muscular Atrophy, Systemic
atrophy and Motor Neuron Disease
Cutaneous Abscess, Cellulitis, and
Lymphangitis
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Paraplegia, Hemiplegia and
Quadriplegia
Cutaneous Abscess, Cellulitis, and
Lymphangitis
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Stages Two-Four and unstageable
pressure ulcers by site
Paraplegia, Hemiplegia and
Quadriplegia
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Stages Two-Four and unstageable
pressure ulcers by site
Paraplegia, Hemiplegia and
Quadriplegia
Epilepsy

Comorbidity
Subgroup
Interaction

Comorbidity Group

Description

Comorbidity Group

Neurological 7

Paraplegia, Hemiplegia and Quadriplegia

Renal 3

Neurological 7

Paraplegia, Hemiplegia and Quadriplegia

Respiratory 5

Neurological 7

Paraplegia, Hemiplegia and Quadriplegia

Skin 4

Renal 1

Chronic kidney disease and ESRD

Skin 1

Renal 1

Chronic kidney disease and ESRD

Skin 3

Renal 1

Chronic kidney disease and ESRD

Skin 4

Renal 3

Renal 3

Renal 3

Respiratory 5

Respiratory 9

Respiratory Failure and Atelectasis

Skin 4

Skin 1

Cutaneous Abscess, Cellulitis, and
Lymphangitis

Skin 3

Skin 3

Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers

Skin 4

Other disorders of the kidney and ureter,
excluding chronic kidney disease and
ESRD
Other disorders of the kidney and ureter,
excluding chronic kidney disease and
ESRD
Other disorders of the kidney and ureter,
excluding chronic kidney disease and
ESRD
Chronic Obstructive Pulmonary Disease,
and Asthma, and Bronchiectasis

Description
Other disorders of the kidney and
ureter, excluding chronic kidney
disease and ESRD
Chronic Obstructive Pulmonary
Disease, and Asthma, and
Bronchiectasis
Stages Two-Four and unstageable
pressure ulcers by site
Cutaneous Abscess, Cellulitis, and
Lymphangitis
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Stages Two-Four and unstageable
pressure ulcers by site

Skin 1

Cutaneous Abscess, Cellulitis, and
Lymphangitis

Skin 3

Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers

Skin 4

Stages Two-Four and unstageable
pressure ulcers by site

Skin 4

Stages Two-Four and unstageable
pressure ulcers by site
Stages Two-Four and unstageable
pressure ulcers by site
Diseases of arteries, arterioles and
capillaries with ulceration and nonpressure chronic ulcers
Stages Two-Four and unstageable
pressure ulcers by site

Source: CY 2023 Home Health Claims Data, Periods that end in CY 2023 accessed from the CCW March 19, 2024.

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 30day 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 30day 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 30day 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 30day 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.

TABLE 24: COEFFICIENT OF PAYMENT REGRESSION AND COEFFICIENT DIVIDED BY AVERAGE RESOURCE
USE

Coefficient

Percentage of
30-Day Periods
for this Model

Coefficient
Divided by
Average
Resource Use

Clinical Group and Functional Impairment Level (MMTA - Other - Low is excluded)
MMTA - Other - Medium Functional
$147.20
MMTA - Other - High Functional
$309.24
MMTA - Surgical Aftercare - Low Functional
-$43.89
MMTA - Surgical Aftercare - Medium Functional
$148.94
MMTA - Surgical Aftercare - High Functional
$361.87
MMTA - Cardiac and Circulatory - Low Functional
-$13.84
MMTA - Cardiac and Circulatory - Medium Functional
$128.54
MMTA - Cardiac and Circulatory - High Functional
$318.95
MMTA - Endocrine - Low Functional
$438.50
MMTA - Endocrine - Medium Functional
$559.02
MMTA - Endocrine - High Functional
$665.69
MMTA - Gastrointestinal tract and Genitourinary system - Low Functional
-$42.67
MMTA - Gastrointestinal tract and Genitourinary system - Medium Functional
$152.74
MMTA - Gastrointestinal tract and Genitourinary system - High Functional
$299.33
MMTA - Infectious Disease, Neoplasms, and Blood-Forming Diseases - Low Functional
-$20.70
MMTA - Infectious Disease, Neoplasms, and Blood-Forming Diseases - Medium Functional
$142.78
MMTA - Infectious Disease, Neoplasms, and Blood-Forming Diseases - High Functional
$357.80
MMTA - Respiratory - Low Functional
-$0.70
MMTA - Respiratory - Medium Functional
$160.36
MMTA - Respiratory - High Functional
$331.15
Behavioral Health - Low Functional
-$75.29
Behavioral Health - Medium Functional
$118.73
Behavioral Health - High Functional
$282.70
Complex - Low Functional
-$77.00
Complex - Medium Functional
$133.21
Complex - High Functional
$110.59
MS Rehab - Low Functional
$62.94
MS Rehab - Medium Functional
$192.17
MS Rehab - High Functional
$421.31
Neuro - Low Functional
$199.52
Neuro - Medium Functional
$384.96
Neuro - High Functional
$612.70
Wound - Low Functional
$599.73
Wound - Medium Functional
$759.02
Wound - High Functional
$946.38
Admission Source with Timing (Community Early is excluded)

1.2%
1.3%
1.2%
1.2%
1.1%
6.1%
5.9%
6.1%
2.6%
2.3%
2.2%
1.7%
1.6%
1.7%
1.6%
1.6%
1.5%
2.8%
2.2%
2.4%
0.8%
0.8%
0.7%
0.9%
0.9%
0.9%
7.3%
7.2%
7.1%
3.2%
3.1%
3.2%
5.3%
4.1%
4.8%

0.0900
0.1890
-0.0268
0.0910
0.2212
-0.0085
0.0786
0.1950
0.2680
0.3417
0.4069
-0.0261
0.0934
0.1830
-0.0127
0.0873
0.2187
-0.0004
0.0980
0.2024
-0.0460
0.0726
0.1728
-0.0471
0.0814
0.0676
0.0385
0.1175
0.2575
0.1220
0.2353
0.3745
0.3666
0.4639
0.5785

Variable

Variable
Community - Late
Institutional - Early
Institutional - Late

Coefficient

Percentage of
30-Day Periods
for this Model

-$571.81
$343.60
$214.04

63.5%
19.1%
6.0%

Comorbidity Adjustment (No Comorbidity Adjustment - is excluded)
Comorbidity Adjustment - Has at least one comorbidity from comorbidity list, no interaction from interaction list
$100.30
Comorbidity Adjustment - Has at least one interaction from interaction list
$344.21
Constant
$1,505.94
Average Resource Use
$1,636.01
Number of 30-day Periods
7,365,273
Adjusted R-Squared
0.3156
Source: CY 2023 Home Health Claims Data, Periods that end in CY 2023 accessed on the CCW March 19, 2024.

Coefficient
Divided by
Average
Resource Use
-0.3495
0.2100
0.1308

The case-mix weights proposed for CY 2025 are listed in table 25 and will also be posted
on the HHA Center webpage8 upon display of this proposed rule.

8 HHA

Center Webpage: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.

TABLE 25: CASE-MIX WEIGHTS AND LUPA THRESHOLDS FOR EACH HHRG PAYMENT GROUP

HIPPS
1FC11
1FC21
1FC31
2FC11
2FC21
2FC31
3FC11
3FC21
3FC31
4FC11
4FC21
4FC31
1FA11
1FA21
1FA31
2FA11
2FA21
2FA31
3FA11
3FA21
3FA31
4FA11
4FA21
4FA31
1FB11
1FB21
1FB31
2FB11
2FB21
2FB31
3FB11
3FB21
3FB31
4FB11
4FB21
4FB31
1DC11
1DC21
1DC31
2DC11
2DC21
2DC31
3DC11
3DC21
3DC31
4DC11

Clinical Group and Functional Level
Behavioral Health - High
Behavioral Health - High
Behavioral Health - High
Behavioral Health - High
Behavioral Health - High
Behavioral Health - High
Behavioral Health - High
Behavioral Health - High
Behavioral Health - High
Behavioral Health - High
Behavioral Health - High
Behavioral Health - High
Behavioral Health - Low
Behavioral Health - Low
Behavioral Health - Low
Behavioral Health - Low
Behavioral Health - Low
Behavioral Health - Low
Behavioral Health - Low
Behavioral Health - Low
Behavioral Health - Low
Behavioral Health - Low
Behavioral Health - Low
Behavioral Health - Low
Behavioral Health - Medium
Behavioral Health - Medium
Behavioral Health - Medium
Behavioral Health - Medium
Behavioral Health - Medium
Behavioral Health - Medium
Behavioral Health - Medium
Behavioral Health - Medium
Behavioral Health - Medium
Behavioral Health - Medium
Behavioral Health - Medium
Behavioral Health - Medium
Complex - High
Complex - High
Complex - High
Complex - High
Complex - High
Complex - High
Complex - High
Complex - High
Complex - High
Complex - High

Admission Source and Timing
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional

Comorbidity Adjustment
(0 = none, 1 = single comorbidity,
2 = interaction)
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
Recalibrated Weight
for 2025
1.0933
1.1546
1.3037
1.3033
1.3646
1.5137
0.7438
0.8051
0.9542
1.2241
1.2854
1.4345
0.8745
0.9358
1.0849
1.0845
1.1458
1.2949
0.5250
0.5863
0.7354
1.0053
1.0666
1.2157
0.9931
1.0544
1.2035
1.2031
1.2644
1.4135
0.6435
0.7049
0.8539
1.1239
1.1852
1.3343
0.9881
1.0494
1.1985
1.1981
1.2594
1.4085
0.6386
0.6999
0.8490
1.1189

LUPA Visit Threshold
(LUPAs have fewer visits
than the threshold)
4
4
4
3
4
4
2
2
2
3
3
4
3
3
3
3
3
3
2
2
2
2
3
2
4
4
4
3
4
4
2
2
2
3
3
3
2
2
2
3
3
3
2
2
2
HIPPS
4DC21
4DC31
1DA11
1DA21
1DA31
2DA11
2DA21
2DA31
3DA11
3DA21
3DA31
4DA11
4DA21
4DA31
1DB11
1DB21
1DB31
2DB11
2DB21
2DB31
3DB11
3DB21
3DB31
4DB11
4DB21
4DB31
1HC11
1HC21
1HC31
2HC11
2HC21
2HC31
3HC11
3HC21
3HC31
4HC11
4HC21
4HC31
1HA11
1HA21
1HA31
2HA11
2HA21
2HA31
3HA11
3HA21
3HA31
4HA11
4HA21

Clinical Group and Functional Level
Complex - High
Complex - High
Complex - Low
Complex - Low
Complex - Low
Complex - Low
Complex - Low
Complex - Low
Complex - Low
Complex - Low
Complex - Low
Complex - Low
Complex - Low
Complex - Low
Complex - Medium
Complex - Medium
Complex - Medium
Complex - Medium
Complex - Medium
Complex - Medium
Complex - Medium
Complex - Medium
Complex - Medium
Complex - Medium
Complex - Medium
Complex - Medium
MMTA - Cardiac - High
MMTA - Cardiac - High
MMTA - Cardiac - High
MMTA - Cardiac - High
MMTA - Cardiac - High
MMTA - Cardiac - High
MMTA - Cardiac - High
MMTA - Cardiac - High
MMTA - Cardiac - High
MMTA - Cardiac - High
MMTA - Cardiac - High
MMTA - Cardiac - High
MMTA - Cardiac - Low
MMTA - Cardiac - Low
MMTA - Cardiac - Low
MMTA - Cardiac - Low
MMTA - Cardiac - Low
MMTA - Cardiac - Low
MMTA - Cardiac - Low
MMTA - Cardiac - Low
MMTA - Cardiac - Low
MMTA - Cardiac - Low
MMTA - Cardiac - Low

Admission Source and Timing
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional

Comorbidity Adjustment
(0 = none, 1 = single comorbidity,
2 = interaction)
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
Recalibrated Weight
for 2025
1.1802
1.3293
0.8734
0.9347
1.0838
1.0834
1.1448
1.2938
0.5239
0.5852
0.7343
1.0043
1.0656
1.2146
1.0019
1.0632
1.2123
1.2119
1.2733
1.4223
0.6524
0.7137
0.8628
1.1327
1.1941
1.3431
1.1154
1.1768
1.3258
1.3255
1.3868
1.5359
0.7659
0.8272
0.9763
1.2463
1.3076
1.4567
0.9120
0.9733
1.1224
1.1221
1.1834
1.3325
0.5625
0.6238
0.7729
1.0429
1.1042

LUPA Visit Threshold
(LUPAs have fewer visits
than the threshold)
2
2
2
2
2
3
3
4
2
2
2
2
2
3
2
2
2
3
3
4
2
2
2
3
3
3
4
4
4
4
4
4
2
2
3
3
3
4
4
4
3
3
4
4
2
2
2
3
HIPPS
4HA31
1HB11
1HB21
1HB31
2HB11
2HB21
2HB31
3HB11
3HB21
3HB31
4HB11
4HB21
4HB31
1IC11
1IC21
1IC31
2IC11
2IC21
2IC31
3IC11
3IC21
3IC31
4IC11
4IC21
4IC31
1IA11
1IA21
1IA31
2IA11
2IA21
2IA31
3IA11
3IA21
3IA31
4IA11
4IA21
4IA31
1IB11
1IB21
1IB31
2IB11
2IB21
2IB31
3IB11
3IB21
3IB31
4IB11
4IB21
4IB31

Clinical Group and Functional Level
MMTA - Cardiac - Low
MMTA - Cardiac - Medium
MMTA - Cardiac - Medium
MMTA - Cardiac - Medium
MMTA - Cardiac - Medium
MMTA - Cardiac - Medium
MMTA - Cardiac - Medium
MMTA - Cardiac - Medium
MMTA - Cardiac - Medium
MMTA - Cardiac - Medium
MMTA - Cardiac - Medium
MMTA - Cardiac - Medium
MMTA - Cardiac - Medium
MMTA - Endocrine - High
MMTA - Endocrine - High
MMTA - Endocrine - High
MMTA - Endocrine - High
MMTA - Endocrine - High
MMTA - Endocrine - High
MMTA - Endocrine - High
MMTA - Endocrine - High
MMTA - Endocrine - High
MMTA - Endocrine - High
MMTA - Endocrine - High
MMTA - Endocrine - High
MMTA - Endocrine - Low
MMTA - Endocrine - Low
MMTA - Endocrine - Low
MMTA - Endocrine - Low
MMTA - Endocrine - Low
MMTA - Endocrine - Low
MMTA - Endocrine - Low
MMTA - Endocrine - Low
MMTA - Endocrine - Low
MMTA - Endocrine - Low
MMTA - Endocrine - Low
MMTA - Endocrine - Low
MMTA - Endocrine - Medium
MMTA - Endocrine - Medium
MMTA - Endocrine - Medium
MMTA - Endocrine - Medium
MMTA - Endocrine - Medium
MMTA - Endocrine - Medium
MMTA - Endocrine - Medium
MMTA - Endocrine - Medium
MMTA - Endocrine - Medium
MMTA - Endocrine - Medium
MMTA - Endocrine - Medium
MMTA - Endocrine - Medium

Admission Source and Timing
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional

Comorbidity Adjustment
(0 = none, 1 = single comorbidity,
2 = interaction)
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
Recalibrated Weight
for 2025
1.2533
0.9991
1.0604
1.2095
1.2091
1.2704
1.4195
0.6495
0.7109
0.8599
1.1299
1.1912
1.3403
1.3274
1.3887
1.5378
1.5374
1.5987
1.7478
0.9779
1.0392
1.1883
1.4582
1.5195
1.6686
1.1885
1.2498
1.3989
1.3985
1.4599
1.6089
0.8390
0.9003
1.0494
1.3194
1.3807
1.5297
1.2622
1.3235
1.4726
1.4722
1.5335
1.6826
0.9127
0.9740
1.1231
1.3930
1.4543
1.6034

LUPA Visit Threshold
(LUPAs have fewer visits
than the threshold)
3
4
4
4
4
4
4
2
2
2
4
3
3
4
4
4
4
4
4
3
3
3
4
4
4
4
4
4
3
4
4
3
3
3
4
3
4
5
4
4
4
4
4
3
3
3
4
4
HIPPS
1JC11
1JC21
1JC31
2JC11
2JC21
2JC31
3JC11
3JC21
3JC31
4JC11
4JC21
4JC31
1JA11
1JA21
1JA31
2JA11
2JA21
2JA31
3JA11
3JA21
3JA31
4JA11
4JA21
4JA31
1JB11
1JB21
1JB31
2JB11
2JB21
2JB31
3JB11
3JB21
3JB31
4JB11
4JB21
4JB31
1KC11
1KC21
1KC31
2KC11
2KC21
2KC31
3KC11
3KC21
3KC31
4KC11
4KC21
4KC31
1KA11

Clinical Group and Functional Level
MMTA - GI/GU - High
MMTA - GI/GU - High
MMTA - GI/GU - High
MMTA - GI/GU - High
MMTA - GI/GU - High
MMTA - GI/GU - High
MMTA - GI/GU - High
MMTA - GI/GU - High
MMTA - GI/GU - High
MMTA - GI/GU - High
MMTA - GI/GU - High
MMTA - GI/GU - High
MMTA - GI/GU - Low
MMTA - GI/GU - Low
MMTA - GI/GU - Low
MMTA - GI/GU - Low
MMTA - GI/GU - Low
MMTA - GI/GU - Low
MMTA - GI/GU - Low
MMTA - GI/GU - Low
MMTA - GI/GU - Low
MMTA - GI/GU - Low
MMTA - GI/GU - Low
MMTA - GI/GU - Low
MMTA - GI/GU - Medium
MMTA - GI/GU - Medium
MMTA - GI/GU - Medium
MMTA - GI/GU - Medium
MMTA - GI/GU - Medium
MMTA - GI/GU - Medium
MMTA - GI/GU - Medium
MMTA - GI/GU - Medium
MMTA - GI/GU - Medium
MMTA - GI/GU - Medium
MMTA - GI/GU - Medium
MMTA - GI/GU - Medium
MMTA - Infectious - High
MMTA - Infectious - High
MMTA - Infectious - High
MMTA - Infectious - High
MMTA - Infectious - High
MMTA - Infectious - High
MMTA - Infectious - High
MMTA - Infectious - High
MMTA - Infectious - High
MMTA - Infectious - High
MMTA - Infectious - High
MMTA - Infectious - High
MMTA - Infectious - Low

Admission Source and Timing
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community

Comorbidity Adjustment
(0 = none, 1 = single comorbidity,
2 = interaction)
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
Recalibrated Weight
for 2025
1.1035
1.1648
1.3139
1.3135
1.3748
1.5239
0.7539
0.8153
0.9643
1.2343
1.2956
1.4447
0.8944
0.9557
1.1048
1.1044
1.1657
1.3148
0.5449
0.6062
0.7553
1.0252
1.0865
1.2356
1.0139
1.0752
1.2242
1.2239
1.2852
1.4343
0.6643
0.7257
0.8747
1.1447
1.2060
1.3551
1.1392
1.2005
1.3496
1.3492
1.4105
1.5596
0.7897
0.8510
1.0001
1.2700
1.3313
1.4804
0.9078

LUPA Visit Threshold
(LUPAs have fewer visits
than the threshold)
3
3
2
4
3
3
2
2
2
3
3
3
2
2
2
3
3
3
2
2
2
3
3
3
3
3
2
3
4
4
2
2
2
3
3
3
2
2
2
3
3
3
2
2
2
3
3
3
HIPPS
1KA21
1KA31
2KA11
2KA21
2KA31
3KA11
3KA21
3KA31
4KA11
4KA21
4KA31
1KB11
1KB21
1KB31
2KB11
2KB21
2KB31
3KB11
3KB21
3KB31
4KB11
4KB21
4KB31
1AC11
1AC21
1AC31
2AC11
2AC21
2AC31
3AC11
3AC21
3AC31
4AC11
4AC21
4AC31
1AA11
1AA21
1AA31
2AA11
2AA21
2AA31
3AA11
3AA21
3AA31
4AA11
4AA21
4AA31
1AB11
1AB21

Clinical Group and Functional Level
MMTA - Infectious - Low
MMTA - Infectious - Low
MMTA - Infectious - Low
MMTA - Infectious - Low
MMTA - Infectious - Low
MMTA - Infectious - Low
MMTA - Infectious - Low
MMTA - Infectious - Low
MMTA - Infectious - Low
MMTA - Infectious - Low
MMTA - Infectious - Low
MMTA - Infectious - Medium
MMTA - Infectious - Medium
MMTA - Infectious - Medium
MMTA - Infectious - Medium
MMTA - Infectious - Medium
MMTA - Infectious - Medium
MMTA - Infectious - Medium
MMTA - Infectious - Medium
MMTA - Infectious - Medium
MMTA - Infectious - Medium
MMTA - Infectious - Medium
MMTA - Infectious - Medium
MMTA - Other - High
MMTA - Other - High
MMTA - Other - High
MMTA - Other - High
MMTA - Other - High
MMTA - Other - High
MMTA - Other - High
MMTA - Other - High
MMTA - Other - High
MMTA - Other - High
MMTA - Other - High
MMTA - Other - High
MMTA - Other - Low
MMTA - Other - Low
MMTA - Other - Low
MMTA - Other - Low
MMTA - Other - Low
MMTA - Other - Low
MMTA - Other - Low
MMTA - Other - Low
MMTA - Other - Low
MMTA - Other - Low
MMTA - Other - Low
MMTA - Other - Low
MMTA - Other - Medium
MMTA - Other - Medium

Admission Source and Timing
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community

Comorbidity Adjustment
(0 = none, 1 = single comorbidity,
2 = interaction)
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
Recalibrated Weight
for 2025
0.9692
1.1182
1.1179
1.1792
1.3283
0.5583
0.6196
0.7687
1.0387
1.1000
1.2491
1.0078
1.0691
1.2182
1.2178
1.2791
1.4282
0.6583
0.7196
0.8686
1.1386
1.1999
1.3490
1.1095
1.1708
1.3199
1.3195
1.3808
1.5299
0.7600
0.8213
0.9704
1.2403
1.3017
1.4507
0.9205
0.9818
1.1309
1.1305
1.1918
1.3409
0.5710
0.6323
0.7814
1.0513
1.1126
1.2617
1.0105
1.0718

LUPA Visit Threshold
(LUPAs have fewer visits
than the threshold)
2
2
3
3
3
2
2
2
3
3
3
3
2
2
3
3
3
2
2
2
3
3
3
4
4
3
4
4
4
2
2
2
3
3
3
3
3
4
3
3
3
2
2
2
3
3
3
4
HIPPS
1AB31
2AB11
2AB21
2AB31
3AB11
3AB21
3AB31
4AB11
4AB21
4AB31
1LC11
1LC21
1LC31
2LC11
2LC21
2LC31
3LC11
3LC21
3LC31
4LC11
4LC21
4LC31
1LA11
1LA21
1LA31
2LA11
2LA21
2LA31
3LA11
3LA21
3LA31
4LA11
4LA21
4LA31
1LB11
1LB21
1LB31
2LB11
2LB21
2LB31
3LB11
3LB21
3LB31
4LB11
4LB21
4LB31
1GC11
1GC21
1GC31

Clinical Group and Functional Level
MMTA - Other - Medium
MMTA - Other - Medium
MMTA - Other - Medium
MMTA - Other - Medium
MMTA - Other - Medium
MMTA - Other - Medium
MMTA - Other - Medium
MMTA - Other - Medium
MMTA - Other - Medium
MMTA - Other - Medium
MMTA - Respiratory - High
MMTA - Respiratory - High
MMTA - Respiratory - High
MMTA - Respiratory - High
MMTA - Respiratory - High
MMTA - Respiratory - High
MMTA - Respiratory - High
MMTA - Respiratory - High
MMTA - Respiratory - High
MMTA - Respiratory - High
MMTA - Respiratory - High
MMTA - Respiratory - High
MMTA - Respiratory - Low
MMTA - Respiratory - Low
MMTA - Respiratory - Low
MMTA - Respiratory - Low
MMTA - Respiratory - Low
MMTA - Respiratory - Low
MMTA - Respiratory - Low
MMTA - Respiratory - Low
MMTA - Respiratory - Low
MMTA - Respiratory - Low
MMTA - Respiratory - Low
MMTA - Respiratory - Low
MMTA - Respiratory - Medium
MMTA - Respiratory - Medium
MMTA - Respiratory - Medium
MMTA - Respiratory - Medium
MMTA - Respiratory - Medium
MMTA - Respiratory - Medium
MMTA - Respiratory - Medium
MMTA - Respiratory - Medium
MMTA - Respiratory - Medium
MMTA - Respiratory - Medium
MMTA - Respiratory - Medium
MMTA - Respiratory - Medium
MMTA - Surgical Aftercare – High
MMTA - Surgical Aftercare – High
MMTA - Surgical Aftercare – High

Admission Source and Timing
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community

Comorbidity Adjustment
(0 = none, 1 = single comorbidity,
2 = interaction)
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
Recalibrated Weight
for 2025
1.2209
1.2205
1.2818
1.4309
0.6610
0.7223
0.8713
1.1413
1.2026
1.3517
1.1229
1.1842
1.3333
1.3329
1.3942
1.5433
0.7734
0.8347
0.9838
1.2537
1.3150
1.4641
0.9201
0.9814
1.1305
1.1301
1.1914
1.3405
0.5706
0.6319
0.7809
1.0509
1.1122
1.2613
1.0185
1.0798
1.2289
1.2285
1.2898
1.4389
0.6690
0.7303
0.8794
1.1493
1.2107
1.3597
1.1417
1.2030
1.3521

LUPA Visit Threshold
(LUPAs have fewer visits
than the threshold)
3
4
4
4
2
2
2
3
3
4
4
3
3
4
4
4
2
2
2
4
3
3
3
3
3
3
3
4
2
2
2
3
3
3
4
3
3
4
4
4
2
2
2
3
3
3
3
3
HIPPS
2GC11
2GC21
2GC31
3GC11
3GC21
3GC31
4GC11
4GC21
4GC31
1GA11
1GA21
1GA31
2GA11
2GA21
2GA31
3GA11
3GA21
3GA31
4GA11
4GA21
4GA31
1GB11
1GB21
1GB31
2GB11
2GB21
2GB31
3GB11
3GB21
3GB31
4GB11
4GB21
4GB31
1EC11
1EC21
1EC31
2EC11
2EC21
2EC31
3EC11
3EC21
3EC31
4EC11
4EC21
4EC31
1EA11
1EA21
1EA31
2EA11

Clinical Group and Functional Level
MMTA - Surgical Aftercare – High
MMTA - Surgical Aftercare – High
MMTA - Surgical Aftercare – High
MMTA - Surgical Aftercare – High
MMTA - Surgical Aftercare – High
MMTA - Surgical Aftercare – High
MMTA - Surgical Aftercare – High
MMTA - Surgical Aftercare – High
MMTA - Surgical Aftercare – High
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare – Low
MMTA - Surgical Aftercare - Medium
MMTA - Surgical Aftercare - Medium
MMTA - Surgical Aftercare - Medium
MMTA - Surgical Aftercare - Medium
MMTA - Surgical Aftercare - Medium
MMTA - Surgical Aftercare - Medium
MMTA - Surgical Aftercare - Medium
MMTA - Surgical Aftercare - Medium
MMTA - Surgical Aftercare - Medium
MMTA - Surgical Aftercare - Medium
MMTA - Surgical Aftercare - Medium
MMTA - Surgical Aftercare - Medium
MS Rehab - High
MS Rehab - High
MS Rehab - High
MS Rehab - High
MS Rehab - High
MS Rehab - High
MS Rehab - High
MS Rehab - High
MS Rehab - High
MS Rehab - High
MS Rehab - High
MS Rehab - High
MS Rehab - Low
MS Rehab - Low
MS Rehab - Low
MS Rehab - Low

Admission Source and Timing
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional

Comorbidity Adjustment
(0 = none, 1 = single comorbidity,
2 = interaction)
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
Recalibrated Weight
for 2025
1.3517
1.4130
1.5621
0.7922
0.8535
1.0026
1.2725
1.3338
1.4829
0.8937
0.9550
1.1041
1.1037
1.1650
1.3141
0.5442
0.6055
0.7545
1.0245
1.0858
1.2349
1.0115
1.0728
1.2219
1.2216
1.2829
1.4319
0.6620
0.7233
0.8724
1.1424
1.2037
1.3528
1.1780
1.2393
1.3884
1.3880
1.4493
1.5984
0.8285
0.8898
1.0389
1.3088
1.3702
1.5192
0.9590
1.0203
1.1694
1.1690

LUPA Visit Threshold
(LUPAs have fewer visits
than the threshold)
4
4
4
2
2
2
3
4
4
2
2
2
3
3
3
2
2
2
2
3
3
3
3
3
3
4
4
2
2
2
3
3
4
4
4
4
5
5
5
2
2
3
4
4
4
4
4
4
HIPPS
2EA21
2EA31
3EA11
3EA21
3EA31
4EA11
4EA21
4EA31
1EB11
1EB21
1EB31
2EB11
2EB21
2EB31
3EB11
3EB21
3EB31
4EB11
4EB21
4EB31
1BC11
1BC21
1BC31
2BC11
2BC21
2BC31
3BC11
3BC21
3BC31
4BC11
4BC21
4BC31
1BA11
1BA21
1BA31
2BA11
2BA21
2BA31
3BA11
3BA21
3BA31
4BA11
4BA21
4BA31
1BB11
1BB21
1BB31
2BB11
2BB21

Clinical Group and Functional Level
MS Rehab - Low
MS Rehab - Low
MS Rehab - Low
MS Rehab - Low
MS Rehab - Low
MS Rehab - Low
MS Rehab - Low
MS Rehab - Low
MS Rehab - Medium
MS Rehab - Medium
MS Rehab - Medium
MS Rehab - Medium
MS Rehab - Medium
MS Rehab - Medium
MS Rehab - Medium
MS Rehab - Medium
MS Rehab - Medium
MS Rehab - Medium
MS Rehab - Medium
MS Rehab - Medium
Neuro - High
Neuro - High
Neuro - High
Neuro - High
Neuro - High
Neuro - High
Neuro - High
Neuro - High
Neuro - High
Neuro - High
Neuro - High
Neuro - High
Neuro - Low
Neuro - Low
Neuro - Low
Neuro - Low
Neuro - Low
Neuro - Low
Neuro - Low
Neuro - Low
Neuro - Low
Neuro - Low
Neuro - Low
Neuro - Low
Neuro - Medium
Neuro - Medium
Neuro - Medium
Neuro - Medium
Neuro - Medium

Admission Source and Timing
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional

Comorbidity Adjustment
(0 = none, 1 = single comorbidity,
2 = interaction)
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
Recalibrated Weight
for 2025
1.2303
1.3794
0.6095
0.6708
0.8198
1.0898
1.1511
1.3002
1.0380
1.0993
1.2483
1.2480
1.3093
1.4584
0.6884
0.7498
0.8988
1.1688
1.2301
1.3792
1.2950
1.3563
1.5054
1.5050
1.5663
1.7154
0.9455
1.0068
1.1559
1.4258
1.4871
1.6362
1.0424
1.1038
1.2528
1.2525
1.3138
1.4629
0.6929
0.7542
0.9033
1.1733
1.2346
1.3837
1.1558
1.2171
1.3662
1.3658
1.4271

LUPA Visit Threshold
(LUPAs have fewer visits
than the threshold)
5
5
2
2
2
4
4
4
5
5
4
5
5
5
2
2
2
4
4
4
4
4
4
5
5
4
2
3
3
4
4
4
4
4
3
4
4
4
2
2
2
3
3
3
4
4
4
5
HIPPS
2BB31
3BB11
3BB21
3BB31
4BB11
4BB21
4BB31
1CC11
1CC21
1CC31
2CC11
2CC21
2CC31
3CC11
3CC21
3CC31
4CC11
4CC21
4CC31
1CA11
1CA21
1CA31
2CA11
2CA21
2CA31
3CA11
3CA21
3CA31
4CA11
4CA21
4CA31
1CB11
1CB21
1CB31
2CB11
2CB21
2CB31
3CB11
3CB21
3CB31
4CB11
4CB21
4CB31

Clinical Group and Functional Level
Neuro - Medium
Neuro - Medium
Neuro - Medium
Neuro - Medium
Neuro - Medium
Neuro - Medium
Neuro - Medium
Wound - High
Wound - High
Wound - High
Wound - High
Wound - High
Wound - High
Wound - High
Wound - High
Wound - High
Wound - High
Wound - High
Wound - High
Wound - Low
Wound - Low
Wound - Low
Wound - Low
Wound - Low
Wound - Low
Wound - Low
Wound - Low
Wound - Low
Wound - Low
Wound - Low
Wound - Low
Wound - Medium
Wound - Medium
Wound - Medium
Wound - Medium
Wound - Medium
Wound - Medium
Wound - Medium
Wound - Medium
Wound - Medium
Wound - Medium
Wound - Medium
Wound - Medium

Admission Source and Timing
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional
Early - Community
Early - Community
Early - Community
Early - Institutional
Early - Institutional
Early - Institutional
Late - Community
Late - Community
Late - Community
Late - Institutional
Late - Institutional
Late - Institutional

Comorbidity Adjustment
(0 = none, 1 = single comorbidity,
2 = interaction)
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
Recalibrated Weight
for 2025
1.5762
0.8063
0.8676
1.0167
1.2866
1.3479
1.4970
1.4990
1.5603
1.7094
1.7090
1.7703
1.9194
1.1494
1.2108
1.3598
1.6298
1.6911
1.8402
1.2871
1.3484
1.4975
1.4971
1.5584
1.7075
0.9376
0.9989
1.1480
1.4179
1.4792
1.6283
1.3844
1.4457
1.5948
1.5945
1.6558
1.8049
1.0349
1.0962
1.2453
1.5153
1.5766
1.7257

Source: CY 2023 Home Health Claims Data, Periods that end in CY 2023 accessed on the CCW March 19, 2024.

LUPA Visit Threshold
(LUPAs have fewer visits
than the threshold)
5
2
2
2
4
4
4
4
4
4
5
4
4
3
3
3
4
4
4
4
4
4
4
4
4
2
3
3
3
4
4
4
4
4
4
5
4
3
3
3
4
4
Changes to the PDGM case-mix weights are implemented in a budget neutral manner by
multiplying the CY 2025 national standardized 30-day period payment rate by a case-mix budget
neutrality factor. Typically, the case-mix weight budget neutrality factor is also calculated using
the most recent, complete home health claims data available. For CY 2025, we will continue the
practice of using the most recent complete home health claims data at the time of rulemaking,
which is CY 2023 data. The case-mix budget neutrality factor is calculated as the ratio of 30-day
base payment rates such that total payments when the CY 2025 PDGM case-mix weights
(developed using CY 2023 home health claims data) are applied to CY 2023 utilization (claims)
data are equal to total payments when CY 2024 PDGM case-mix weights (developed using CY
2022 home health claims data) are applied to CY 2023 utilization data. This produces a
case-mix budget neutrality factor for CY 2025 of 1.0035.
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 webpage.
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).
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 economywide private nonfarm business multifactor productivity (as projected by the Secretary for the 10year 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/medicareprogram-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.
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-1701.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-statisticalareas.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/wpcontent/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 nonMetropolitan Statistical Areas (MSAs). In the CY 2021 HH PPS final rule (85 FR 70298), we
finalized a policy to continue to treat Micropolitan Areas as “rural” and to include Micropolitan
Areas in the calculation of each state’s rural wage index.
The OMB “2020 Standards” continue to define a “Micropolitan Statistical Area” as a
CBSA with at least one urban area that has a population of at least 10,000, but less than 50,000.
The Micropolitan Statistical Area comprises the central county or counties containing the core,
plus adjacent outlying counties having a high degree of social and economic integration with the
central county, or counties as measured through commuting (86 FR 37778). Overall, there are
the same number of Micropolitan Areas (542) under the new OMB delineations based on the

2020 Census as there were using the 2010 Census. We note, however, that a number of urban
counties have switched status and have joined or become Micropolitan Areas, and some counties
that once were part of a Micropolitan Area, and thus were treated as rural, have become urban
based on the 2020 Decennial Census data. 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 countyequivalents 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.
TABLE 26: CROSSWALK OF CONNECTICUT COUNTY EQUIVALENTS

FIPS
County
Code
09001
County
FAIRFIELD
FAIRFIELD

Old
CBSA or
NonNew FIPS
urban
County
Area
Code
FY 2025 Planning Region
14860 09190
WESTERN CONNECTICUT
14860 09120
GREATER BRIDGEPORT

New CBSA
or
Non-urban
Area
14860
09003
09005
09007
09009
09009
09011
09013
HARTFORD
LITCHFIELD
MIDDLESEX
NEW HAVEN
NEW HAVEN
NEW LONDON
TOLLAND
WINDHAM

25540
99907
25540
35300
35300
35980
25540
09110
09160
09130
09140
09170
09180
09110
CAPITOL
NORTHWEST HILLS
LOWER CONNECTICUT RIVER VALLEY
NAUGATUCK VALLEY
SOUTH CENTRAL CONNECTICUT
SOUTHEASTERN CONNECTICUT
CAPITOL
NORTHEASTERN CONNECTICUT

25540
99907
25540
47930
35300
35980
25540
c. Urban Counties That Would Become Rural
Under the revised OMB statistical area delineations (based upon OMB Bulletin No. 2301), 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.
TABLE 27: URBAN COUNTIES THAT WOULD CHANGE TO RURAL STATUS
FIPS County
Code
01129
05025
05047
05069
05079
10005
13171
16077
17057
17077
17087
17183
17199
18121
18133
18161
21091
21101
22045
24001
24047
25011
26155
27075
28031
31051
36123
37049
37077
37085
37087
County Name
WASHINGTON
CLEVELAND
FRANKLIN
JEFFERSON
LINCOLN
SUSSEX
LAMAR
POWER
FULTON
JACKSON
JOHNSON
VERMILION
WILLIAMSON
PARKE
PUTNAM
UNION
HANCOCK
HENDERSON
IBERIA
ALLEGANY
WORCESTER
FRANKLIN
SHIAWASSEE
LAKE
COVINGTON
DIXON
YATES
CRAVEN
GRANVILLE
HARNETT
HAYWOOD
JONES

State
AL
AR
AR
AR
AR
DE
GA
ID
IL
IL
IL
IL
IL
IN
IN
IN
KY
KY
LA
MD
MD
MA
MI
MN
MS
NE
NY
NC
NC
NC
NC
NC

Current
CBSA
33660
38220
22900
38220
38220
41540
12060
38540
37900
16060
16060
19180
16060
45460
26900
17140
36980
21780
29180
19060
41540
44140
29620
20260
25620
43580
40380
35100
20500
22180
11700
Current CBSA Name
Mobile, AL
Pine Bluff, AR
Fort Smith, AR-OK
Pine Bluff, AR
Pine Bluff, AR
Salisbury, MD-DE
Atlanta-Sandy Springs-Alpharetta, GA
Pocatello, ID
Peoria, IL
Carbondale-Marion, IL
Carbondale-Marion, IL
Danville, IL
Carbondale-Marion, IL
Terre Haute, IN
Indianapolis-Carmel-Anderson, IN
Cincinnati, OH-KY-IN
Owensboro, KY
Evansville, IN-KY
Lafayette, LA
Cumberland, MD-WV
Salisbury, MD-DE
Springfield, MA
Lansing-East Lansing, MI
Duluth, MN-WI
Hattiesburg, MS
Sioux City, IA-NE-SD
Rochester, NY
New Bern, NC
Durham-Chapel Hill, NC
Fayetteville, NC
Asheville, NC
New Bern, NC

FIPS County
Code
37137
42037
42085
42089
42093
42103
45027
48431
49003
51113
51175
51620
54035
54043
54057
55069
72001
72055
72081
72083
County Name
PAMLICO
COLUMBIA
MERCER
MONROE
MONTOUR
PIKE
CLARENDON
STERLING
BOX ELDER
MADISON
SOUTHAMPTON
FRANKLIN CITY
JACKSON
LINCOLN
MINERAL
LINCOLN
ADJUNTAS
GUANICA
LARES
LAS MARIAS
UTUADO

State
NC
PA
PA
PA
PA
PA
SC
TX
UT
VA
VA
VA
WV
WV
WV
WI
PR
PR
PR
PR
PR

Current
CBSA
35100
14100
49660
20700
14100
35084
44940
41660
36260
47894
47260
47260
16620
16620
19060
48140
38660
49500
10380
32420
Current CBSA Name
New Bern, NC
Bloomsburg-Berwick, PA
Youngstown-Warren-Boardman, OH-PA
East Stroudsburg, PA
Bloomsburg-Berwick, PA
Newark, NJ-PA
Sumter, SC
San Angelo, TX
Ogden-Clearfield, UT
Washington-Arlington-Alexandria, DC-VA-MD-WV
Virginia Beach-Norfolk-Newport News, VA-NC
Virginia Beach-Norfolk-Newport News, VA-NC
Charleston, WV
Charleston, WV
Cumberland, MD-WV
Wausau-Weston, WI
Ponce, PR
Yauco, PR
Aguadilla-Isabela, PR
Mayagüez, PR
Aguadilla-Isabela, PR

d. Rural Counties That Would Become Urban
Under the revised OMB statistical area delineations (based upon OMB Bulletin No. 2301), 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.
TABLE 28: RURAL COUNTIES THAT WOULD CHANGE TO URBAN STATUS
FIPS County
Code
01087
01127
12133
13187
15005
17053
17127
18159
18179
20021
21007
21039
21127
21139
21145
21179
22053
County Name
MACON
WALKER
WASHINGTON
LUMPKIN
KALAWAO
FORD
MASSAC
TIPTON
WELLS
CHEROKEE
BALLARD
CARLISLE
LAWRENCE
LIVINGSTON
MC CRACKEN
NELSON
JEFFRSON DAVIS
RICHLAND

State
AL
AL
FL
GA
HI
IL
IL
IN
IN
KS
KY
KY
KY
KY
KY
KY
LA
LA

Proposed
CY 2025
CBSA
12220
13820
37460
12054
27980
16580
37140
26900
23060
27900
37140
37140
26580
37140
37140
31140
29340
Proposed CY 2025 CBSA Name
Auburn-Opelika, AL
Birmingham, AL
Panama City-Panama City Beach, FL
Atlanta-Sandy Springs-Roswell, GA
Kahului-Wailuku, HI
Champaign-Urbana, IL
Paducah, KY-IL
Indianapolis-Carmel-Greenwood, IN
Fort Wayne, IN
Joplin, MO-KS
Paducah, KY-IL
Paducah, KY-IL
Huntington-Ashland, WV-KY-OH
Paducah, KY-IL
Paducah, KY-IL
Louisville/Jefferson County, KY-IN
Lake Charles, LA
Monroe, LA

FIPS County
Code
26015
26019
26055
26079
26089
27133
28009
28123
30007
30031
30043
30049
30061
32019
37125
38049
38075
38101
39007
39043
41013
41031
42073
45087
46033
47081
48007
48035
48079
48169
48219
48323
48407
51063
51181
County Name
BARRY
BENZIE
GRAND TRAVERSE
KALKASKA
LEELANAU
ROCK
BENTON
SCOTT
BROADWATER
GALLATIN
JEFFERSON
LEWIS AND CLARK
MINERAL
LYON
MOORE
MCHENRY
RENVILLE
WARD
ASHTABULA
ERIE
CROOK
JEFFERSON
LAWRENCE
UNION
CUSTER
HICKMAN
ARANSAS
BOSQUE
COCHRAN
GARZA
HOCKLEY
MAVERICK
SAN JACINTO
FLOYD
SURRY
VERNON

State
MI
MI
MI
MI
MI
MN
MS
MS
MT
MT
MT
MT
MT
NV
NC
ND
ND
ND
OH
OH
OR
OR
PA
SC
SD
TN
TX
TX
TX
TX
TX
TX
TX
VA
VA
WI

Proposed
CY 2025
CBSA
24340
45900
45900
45900
45900
43620
32820
27140
25740
14580
25740
25740
33540
39900
38240
33500
33500
33500
17410
41780
13460
13460
38300
43900
39660
34980
18580
47380
31180
31180
31180
20580
26420
13980
47260
Proposed CY 2025 CBSA Name
Grand Rapids-Wyoming-Kentwood, MI
Traverse City, MI
Traverse City, MI
Traverse City, MI
Traverse City, MI
Sioux Falls, SD-MN
Memphis, TN-MS-AR
Jackson, MS
Helena, MT
Bozeman, MT
Helena, MT
Helena, MT
Missoula, MT
Reno, NV
Pinehurst-Southern Pines, NC
Minot, ND
Minot, ND
Minot, ND
Cleveland, OH
Sandusky, OH
Bend, OR
Bend, OR
Pittsburgh, PA
Spartanburg, SC
Rapid City, SD
Nashville-Davidson--Murfreesboro--Franklin, TN
Corpus Christi, TX
Waco, TX
Lubbock, TX
Lubbock, TX
Lubbock, TX
Eagle Pass, TX
Houston-Pasadena-The Woodlands, TX
Blacksburg-Christiansburg-Radford, VA
Virginia Beach-Chesapeake-Norfolk, VA-NC
La Crosse-Onalaska, WI-MN

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 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).
TABLE 29: URBAN AREAS WITH CBSA NAME AND/OR NUMBER CHANGE
Current
CBSA
Code
10380
10540
12420
12540
13820
13980
15260
15680
16540
16984
17460
19430
19740
21060
21780
21820
22660
23224
23844
24340
24860
25940
26380
26420
26900
27900
27980
29404
29820
31020
34740
34820
35084
35154
35840
36084
36260
36540
37460
39100
39340
39540
41540
41620
42680
42700
43620
44420
44700
45540
47220
47260
48140
Current CBSA Name
Aguadilla-Isabela, PR
Albany-Lebanon, OR
Austin-Round Rock-Georgetown, TX
Bakersfield, CA
Birmingham-Hoover, AL
Blacksburg-Christiansburg, VA
Brunswick, GA
California-Lexington Park, MD
Chambersburg-Waynesboro, PA
Chicago-Naperville-Evanston, IL
Cleveland-Elyria, OH
Dayton-Kettering, OH
Denver-Aurora-Lakewood, CO
Elizabethtown-Fort Knox, KY
Evansville, IN-KY
Fairbanks, AK
Fort Collins, CO
Frederick-Gaithersburg-Rockville, MD
Gary, IN
Grand Rapids-Kentwood, MI
Greenville-Anderson, SC
Hilton Head Island-Bluffton, SC
Houma-Thibodaux, LA
Houston-The Woodlands-Sugar Land, TX
Indianapolis-Carmel-Anderson, IN
Joplin, MO
Kahului-Wailuku-Lahaina, HI
Lake County-Kenosha County, IL-WI
Las Vegas-Henderson-Paradise, NV
Longview, WA
Muskegon, MI
Myrtle Beach-Conway-North Myrtle Beach, SC-NC
Newark, NJ-PA
New Brunswick-Lakewood, NJ
North Port-Sarasota-Bradenton, FL
Oakland-Berkeley-Livermore, CA
Ogden-Clearfield, UT
Omaha-Council Bluffs, NE-IA
Panama City, FL
Poughkeepsie-Newburgh-Middletown, NY
Provo-Orem, UT
Racine, WI
Salisbury, MD-DE
Salt Lake City, UT
Sebastian-Vero Beach, FL
Sebring-Avon Park, FL
Sioux Falls, SD
Staunton, VA
Stockton, CA
The Villages, FL
Vineland-Bridgeton, NJ
Virginia Beach-Norfolk-Newport News, VA-NC
Wausau-Weston, WI
Wenatchee, WA

Proposed
CY 2025
CBSA
Code
10380
10540
12420
12540
13820
13980
15260
30500
16540
16984
17410
19430
19740
21060
21780
21820
22660
23224
29414
24340
24860
25940
26380
26420
26900
27900
27980
29404
29820
31020
34740
34820
35084
29484
35840
36084
36260
36540
37460
28880
39340
39540
41540
41620
42680
42700
43620
44420
44700
48680
47220
47260
48140
Proposed CY 2025 CBSA Name
Aguadilla, PR
Albany, OR
Austin-Round Rock-San Marcos, TX
Bakersfield-Delano, CA
Birmingham, AL
Blacksburg-Christiansburg-Radford, VA
Brunswick-St. Simons, GA
Lexington Park, MD
Chambersburg, PA
Chicago-Naperville-Schaumburg, IL
Cleveland, OH
Dayton-Kettering-Beavercreek, OH
Denver-Aurora-Centennial, CO
Elizabethtown, KY
Evansville, IN
Fairbanks-College, AK
Fort Collins-Loveland, CO
Frederick-Gaithersburg-Bethesda, MD
Lake County-Porter County-Jasper County, IN
Grand Rapids-Wyoming-Kentwood, MI
Greenville-Anderson-Greer, SC
Hilton Head Island-Bluffton-Port Royal, SC
Houma-Bayou Cane-Thibodaux, LA
Houston-Pasadena-The Woodlands, TX
Indianapolis-Carmel-Greenwood, IN
Joplin, MO-KS
Kahului-Wailuku, HI
Lake County, IL
Las Vegas-Henderson-North Las Vegas, NV
Longview-Kelso, WA
Muskegon-Norton Shores, MI
Myrtle Beach-Conway-North Myrtle Beach, SC
Newark, NJ
Lakewood-New Brunswick, NJ
North Port-Bradenton-Sarasota, FL
Oakland-Fremont-Berkeley, CA
Ogden, UT
Omaha, NE-IA
Panama City-Panama City Beach, FL
Kiryas Joel-Poughkeepsie-Newburgh, NY
Provo-Orem-Lehi, UT
Racine-Mount Pleasant, WI
Salisbury, MD
Salt Lake City-Murray, UT
Sebastian-Vero Beach-West Vero Corridor, FL
Sebring, FL
Sioux Falls, SD-MN
Staunton-Stuarts Draft, VA
Stockton-Lodi, CA
Wildwood-The Villages, FL
Vineland, NJ
Virginia Beach-Chesapeake-Norfolk, VA-NC
Wausau, WI
Wenatchee-East Wenatchee, WA

Current
CBSA
Code
48424
49340
Current CBSA Name
West Palm Beach-Boca Raton-Boynton Beach, FL
Worcester, MA-CT
Youngstown-Warren-Boardman, OH-PA

Proposed
CY 2025
CBSA
Code
48424
49340
Proposed CY 2025 CBSA Name
West Palm Beach-Boca Raton-Delray Beach, FL
Worcester, MA
Youngstown-Warren, OH

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.
TABLE 30: URBAN AREAS THAT WOULD BE SUBSUMED BY ANOTHER CBSA
Current CBSA
Code
31460
36140
Current CBSA Name
Madera, CA
Ocean City, NJ
San Germán, PR

Proposed CY
2025 CBSA Code
23420
12100
Proposed CY 2025 CBSA Name
Fresno, CA
Atlantic City-Hammonton, NJ
Mayagüez, PR

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-ArlingtonAlexandria, 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.

TABLE 31: COUNTIES THAT WOULD CHANGE TO A DIFFERENT URBAN CBSA
FIPS County
Code
13013
13035
13045
13063
13077
13085
13089
13097
13113
13117
13121
13135
13149
13151
13159
13199
13211
13217
13227
13231
13247
13255
13297
13015
13057
13067
13143
13223
21163
17097
55059
06039
47057
37019
22103
34009
72023
72079
72121
72125
53061
25015
12103
12053
12057
12101
County Name
BARROW
BUTTS
CARROLL
CLAYTON
COWETA
DAWSON
DE KALB
DOUGLAS
FAYETTE
FORSYTH
FULTON
GWINNETT
HEARD
HENRY
JASPER
MERIWETHER
MORGAN
NEWTON
PICKENS
PIKE
ROCKDALE
SPALDING
WALTON
BARTOW
CHEROKEE
COBB
HARALSON
PAULDING
MEADE
LAKE
KENOSHA
MADERA
GRAINGER
BRUNSWICK
ST. TAMMANY
CAPE MAY
CABO ROJO
LAJAS
SABANA GRANDE
SAN GERMAN
SNOHOMISH
HAMPSHIRE
PINELLAS
HERNANDO
HILLSBOROUGH
PASCO
OTTAWA

State
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
GA
KY
IL
WI
CA
TN
NC
LA
NJ
PR
PR
PR
PR
WA
MA
FL
FL
FL
FL
OH

Current
CBSA
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
12060
21060
29404
29404
31460
34100
34820
35380
36140
41900
41900
41900
41900
42644
44140
45300
45300
45300
45300
Current CBSA Name
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Atlanta-Sandy Springs-Alpharetta, GA
Elizabethtown-Fort Knox, KY
Lake County-Kenosha County, IL-WI
Lake County-Kenosha County, IL-WI
Madera, CA
Morristown, TN
Myrtle Beach-Conway-North Myrtle Beach, SC-NC
New Orleans-Metairie, LA
Ocean City, NJ
San Germán, PR
San Germán, PR
San Germán, PR
San Germán, PR
Seattle-Bellevue-Kent, WA
Springfield, MA
Tampa-St. Petersburg-Clearwater, FL
Tampa-St. Petersburg-Clearwater, FL
Tampa-St. Petersburg-Clearwater, FL
Tampa-St. Petersburg-Clearwater, FL
Toledo, OH

Proposed
CY 2025
CBSA
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
12054
31924
31924
31924
31924
31924
31140
29404
28450
23420
28940
48900
43640
12100
32420
32420
32420
32420
21794
11200
41304
45294
45294
45294
Proposed CY 2025 CBSA Name
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Atlanta-Sandy Springs-Roswell, GA
Marietta, GA
Marietta, GA
Marietta, GA
Marietta, GA
Marietta, GA
Louisville/Jefferson County, KY-IN
Lake County, IL
Kenosha, WI
Fresno, CA
Knoxville, TN
Wilmington, NC
Slidell-Mandeville-Covington, LA
Atlantic City-Hammonton, NJ
Mayagüez, PR
Mayagüez, PR
Mayagüez, PR
Mayagüez, PR
Everett, WA
Amherst Town-Northampton, MA
St. Petersburg-Clearwater-Largo, FL
Tampa, FL
Tampa, FL
Tampa, FL
Sandusky, OH

FIPS County
Code
51013
51043
51047
51059
51061
51107
51153
51157
51177
51179
51187
51510
51600
51610
51630
51683
51685
54037
11001
24017
24033
24009
24037
72059
72111
County Name
ARLINGTON
CLARKE
CULPEPER
FAIRFAX
FAUQUIER
LOUDOUN
PRINCE WILLIAM
RAPPAHANNOCK
SPOTSYLVANIA
STAFFORD
WARREN
ALEXANDRIA CITY
FAIRFAX CITY
FALLS CHURCH CITY
FREDERICKSBURG CITY
MANASSAS CITY
MANASSAS PARK CITY
JEFFERSON
THE DISTRICT
CHARLES
PRINCE GEORGES
CALVERT
ST. MARYS
GUAYANILLA
PENUELAS
YAUCO

State
VA
VA
VA
VA
VA
VA
VA
VA
VA
VA
VA
VA
VA
VA
VA
VA
VA
WV
DC
MD
MD
MD
MD
PR
PR
PR

Current
CBSA
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
47894
15680
49500
49500
Current CBSA Name
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
Washington-Arlington-Alexandria, DC-VA-MD-WV
California-Lexington Park, MD
Yauco, PR
Yauco, PR
Yauco, PR

Proposed
CY 2025
CBSA
11694
11694
11694
11694
11694
11694
11694
11694
11694
11694
11694
11694
11694
11694
11694
11694
11694
11694
47764
47764
47764
30500
30500
38660
38660
Proposed CY 2025 CBSA Name
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Arlington-Alexandria-Reston, VA-WV
Washington, DC-MD
Washington, DC-MD
Washington, DC-MD
Lexington Park, MD
Lexington Park, MD
Ponce, PR
Ponce, PR
Ponce, PR

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 50XXX9 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 5percent 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.
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

9 The

remaining 3 characters of the code to be determined if finalized.

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.
TABLE 32: COUNTIES THAT WOULD USE A WAGE INDEX
TRANSITION CODE

County Name
WASHINGTON
FRANKLIN
LAMAR
KALAWAO
POWER
VERMILION
PUTNAM
HENDERSON
IBERIA

State
AL
AR
GA
HI
ID
IL
IN
KY
LA

CY
2024
CBSA
33660
22900
12060
99912
38540
19180
26900
21780
CALVERT
WORCESTER
FRANKLIN
SHIAWASSEE
LAKE
ROCK
LYON
YATES
GRANVILLE
HAYWOOD
OTTAWA
PIKE

MD
MD
MA
MI
MN
MN
NV
NY
NC
NC
OH
PA

47894
41540
44140
29620
20260
99924
99929
40380
20500
11700
45780
MADISON
SOUTHAMPTON
FRANKLIN CITY
JACKSON
LINCOLN
MINERAL
ADJUNTAS
CABO ROJO
GUANICA
LAJAS
LARES
LAS MARIAS
SABANA GRANDE
SAN GERMAN
UTUADO

VA
VA
VA
WV
WV
WV
PR
PR
PR
PR
PR
PR
PR
PR
PR

47894
47260
47260
16620
16620
19060
38660
41900
49500
41900
10380
32420
41900
41900
CY 2024 CBSA Name
Mobile, AL
Fort Smith, AR-OK
Atlanta-Sandy Springs-Alpharetta, GA
HAWAII
Pocatello, ID
Danville, IL
Indianapolis-Carmel-Anderson, IN
Evansville, IN-KY
Lafayette, LA
Washington-Arlington-Alexandria, DC-VA-MDWV
Salisbury, MD-DE
Springfield, MA
Lansing-East Lansing, MI
Duluth, MN-WI
MINNESOTA
NEVADA
Rochester, NY
Durham-Chapel Hill, NC
Asheville, NC
Toledo, OH
Newark, NJ-PA
Washington-Arlington-Alexandria, DC-VA-MDWV
Virginia Beach-Norfolk-Newport News, VA-NC
Virginia Beach-Norfolk-Newport News, VA-NC
Charleston, WV
Charleston, WV
Cumberland, MD-WV
Ponce, PR
San Germán, PR
Yauco, PR
San Germán, PR
Aguadilla-Isabela, PR
Mayagüez, PR
San Germán, PR
San Germán, PR
Aguadilla-Isabela, PR

Proposed
CY 2025
CBSA
99901
99904
99911
27980
99913
99914
99915
99918
Proposed CY 2025 CBSA
Name
ALABAMA
ARKANSAS
GEORGIA
Kahului-Wailuku, HI
IDAHO
ILLINOIS
INDIANA
KENTUCKY
LOUISIANA

30500
99921
99922
99923
99924
43620
39900
99933
99934
99934
41780
Lexington Park, MD
MARYLAND
MASSACHUSETTS
MICHIGAN
MINNESOTA
Sioux Falls, SD-MN
Reno, NV
NEW YORK
NORTH CAROLINA
NORTH CAROLINA
Sandusky, OH
PENNSYLVANIA

50010
50011
50012
50013
50014
50015
50016
50017
50018
50019
50020
99949
99949
99949
99951
99951
99951
99940
32420
99940
32420
99940
99940
32420
32420
VIRGINIA
VIRGINIA
VIRGINIA
WEST VIRGINIA
WEST VIRGINIA
WEST VIRGINIA
PUERTO RICO
Mayagüez, PR
PUERTO RICO
Mayagüez, PR
PUERTO RICO
PUERTO RICO
Mayagüez, PR
Mayagüez, PR
PUERTO RICO

50022
50023
50023
50024
50024
50025
50026
50027
50028
50027
50029
50028
50027
50027
Transition
Code
50001
50002
50003
50004
50005
50006
50007
50008
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-healthagency-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 prefloor, 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 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, prereclassified 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.
TABLE 33: CY 2025 WAGE INDEX FOR RURAL NORTH DAKOTA

CBSA Code
13900
22020
24220
CBSA Name
Bismarck, ND
Fargo, ND-MN
Grand Forks, ND-MN
Minot, ND
Proposed CY 2025 HH PPS Wage Index

CY 2025 HH PPS
Wage Index
0.9020
0.8763
0.7865
0.7686
0.8334

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 § 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 and § 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 wageadjusted 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 §§ 484.205(d)(1) and 484.230.
● A partial payment adjustment as set forth in §§ 484.205(d)(2) and 484.235.
● An outlier payment as set forth in §§ 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.

TABLE 34: CY 2025 NATIONAL, STANDARDIZED 30-DAY PERIOD PAYMENT
AMOUNT
CY 2024
National
Standardized
30-Day Period
Payment
$2,038.13

Permanent
Adjustment
Factor
0.95933

Case-Mix
Weights
Recalibration
Budget
Neutrality
Factor
1.0035

Wage
Index
Budget
Neutrality
Factor
0.9985

CY 2025
CY 2025
National,
HH
Standardized
Payment
30-Day
Update
Period
Factor
Payment
1.025
$2,008.12

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.
TABLE 35: CY 2025 NATIONAL, STANDARDIZED 30-DAY PERIOD PAYMENT
AMOUNT FOR HHAs THAT DO NOT SUBMIT THE QUALITY DATA

CY 2024
National
Standardized
30-Day Period
Payment
$2,038.13

Permanent
Adjustment
Factor
0.95933

Case-Mix
Weights
Recalibration
Neutrality
Factor
1.0035

CY 2025
HH
Payment
CY 2025
Wage
Update
National,
Index
Factor
Standardized
Budget
Minus 2
30-Day
Neutrality Percentage
Period
Factor
Points
Payment
0.9985
1.005
$1,968.94

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.

TABLE 36: CY 2025 NATIONAL PER-VISIT PAYMENT AMOUNTS

HH Discipline
Home Health Aide
Medical Social Services
Occupational Therapy
Physical Therapy
Skilled Nursing
Speech-Language Pathology

CY 2024
Per-Visit
Payment
Amount
$76.23
$269.87
$185.29
$184.03
$168.37
$200.04

Wage Index
Budget
Neutrality
Factor
0.9991
0.9991
0.9991
0.9991
0.9991
0.9991

CY 2025 HH
Payment
Update Factor

CY 2025 PerVisit Payment
Amount

1.025
1.025
1.025
1.025
1.025
1.025

$78.07
$276.37
$189.75
$188.46
$172.42
$204.86

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.
TABLE 37: CY 2024 NATIONAL PER-VISIT PAYMENT AMOUNTS FOR HHAs THAT
DO NOT SUBMIT THE REQUIRED QUALITY DATA

HH Discipline
Home Health Aide
Medical Social Services
Occupational Therapy
Physical Therapy
Skilled Nursing
Speech-Language Pathology

CY 2024 PerVisit Payment
Amount
$76.23
$269.87
$185.29
$184.03
$168.37
$200.04

Wage Index
Budget
Neutrality
Factor
0.9991
0.9991
0.9991
0.9991
0.9991
0.9991

CY 2025 HH
Payment
Update Factor
Minus 2
Percentage
Points
1.005
1.005
1.005
1.005
1.005
1.005

CY 2025 PerVisit Payment
Amount
$76.54
$270.98
$186.05
$184.78
$169.06
$200.86

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 pervisit 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 pervisit 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 addon 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:
TABLE 38: CURRENT AND PROPOSED LUPA ADD-ON FACTORS

Discipline
SN
PT
SLP
OT

Current
LUPA
Add-on
Factors
1.8451
1.6700
1.6266
1.6700

Proposed LUPA
Add-on Factors
Using Data from
CY2023
1.7227
1.6247
1.6703
1.7266

Percent Change from
Old to New

Average Excess of
Minutes for the First
Visit in LUPA Periods

Average Minutes for All
Non-First Visits in NonLUPA Episodes

-6.6%
-2.7%
+2.7%
+3.4%

30.00
28.18
31.59
33.40

41.51
45.11
47.13
45.97

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 § 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 addon 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 addon 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 nonLUPA 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 fixeddollar loss (FDL) amount. For the purposes of the HH PPS, the FDL amount is calculated by
multiplying the home health FDL ratio by a case’s wage-adjusted national, standardized 60-day
episode payment rate, which yields an FDL dollar amount for the case. The outlier threshold
amount is the sum of the wage and case-mix adjusted PPS episode amount and wage-adjusted
FDL amount. The outlier payment is defined to be a proportion of the wage-adjusted estimated
cost that surpasses the wage-adjusted threshold. The proportion of additional costs over the
outlier threshold amount paid as outlier payments is referred to as the loss-sharing ratio.
As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through 70399), section
3131(b)(1) of the Affordable Care Act amended section 1895(b)(3)(C) of the Act to require that
the Secretary reduce the HH PPS payment rates such that aggregate HH PPS payments were
reduced by 5 percent. In addition, section 3131(b)(2) of the Affordable Care Act amended
section 1895(b)(5) of the Act by redesignating the existing language as section 1895(b)(5)(A) of
the Act and revised the language to state that the total amount of the additional payments or

payment adjustments for outlier episodes could not exceed 2.5 percent of the estimated total HH
PPS payments for that year. Section 3131(b)(2)(C) of the Affordable Care Act also added
section 1895(b)(5)(B) of the Act, which capped outlier payments as a percent of total payments
for each HHA for each year at 10 percent.
As such, beginning in CY 2011, we reduced payment rates by 5 percent and targeted up
to 2.5 percent of total estimated HH PPS payments to be paid as outliers. To do so, we first
returned the 2.5 percent held for the target CY 2010 outlier pool to the national, standardized 60day 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 reestimate 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
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-agencycenter. For more in-depth information regarding the finalized policies associated with the scope
of the payment for dNPWT and conditions for payment, we refer readers to the CY 2024 HH
PPS final rule (88 FR 77749 through 77752).

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

TABLE 39: MEASURES CURRENTLY ADOPTED FOR THE CY 2024 HH QRP
Short Name
QM Name
Ambulation
Application of Falls
Application of Functional Assessment
Bathing
Bed Transferring
Patient COVID-19 Vaccination
DRR
DC Function
Dyspnea
Influenza
Oral Medications
Pressure Ulcer/Injury
Timely Care
TOH -Provider
TOH -Patient
QM Name
ACH
DTC
ED Use
MSPB
PPR
PPH
QM Name
CAHPS Home Health Survey

Measure Name & Data Source
OASIS-based
Improvement in Ambulation/Locomotion (CBE #0167).
Application of Percent of Residents Experiencing One or More Falls with Major Injury (Long Stay) (CBE #0674).
Application of Percent of Long-Term Care Hospital (LTCH) Patients with an Admission and Discharge Functional
Assessment and a Care Plan That Addresses Function (CBE #2631).4
Improvement in Bathing (CBE #0174).
Improvement in Bed Transferring (CBE # 0175).
COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to Date
Drug Regimen Review Conducted With Follow-Up for Identified Issues- Post Acute Care (PAC) HH QRP.
Discharge Function Score
Improvement in Dyspnea.
Influenza Immunization Received for Current Flu Season
Improvement in Management of Oral Medications (CBE #0176).
Changes in Skin Integrity Post-Acute Care
Timely Initiation Of Care (CBE #0526).
Transfer of Health Information to Provider-Post-Acute Care1
Transfer of Health Information to Patient-Post-Acute Care1
Claims-based
Acute Care Hospitalization During the First 60 Days of HH (CBE #0171)3
Discharge to Community-Post Acute Care (PAC) Home Health (HH) Quality Reporting Program (QRP) (CBE #3477)
Emergency Department Use without Hospitalization During the First 60 Days of HH (CBE #0173) 3
Total Estimated Medicare Spending Per Beneficiary (MSPB)—Post Acute Care (PAC) HH QRP.
Potentially Preventable 30-Day Post-Discharge Readmission Measure for HH Quality Reporting Program.
Home Health Within Stay Potentially Preventable Hospitalization
HHCAHPS-based
CAHPS® Home Health Care Survey (experience with care) (CBE #0517)2
- How often the HH team gave care in a professional way.
- How well did the HH team communicate with patients.
- Did the HH team discuss medicines, pain, and home safety with patients.
- How do patients rate the overall care from the HHA.
- Will patients recommend the HHA to friends and family.

NOTES: 1. Data collection delayed due to the COVID-19 public health emergency for the TOH-Patient and TOH-Provider. 2. The HHCAHPS has five components that together are used to represent
one CBE-endorsed measure. 3. ACH and ED Use will be retired from public reporting in October 2024 4. Application of Functional Assessment will be retired from public reporting in January 2025.

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 items10 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.
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,

10 Items may also be referred to as “data elements.”

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

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/healthtopics/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/healthequity-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).

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).
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

18 These SDOH data are also collected for purposes outlined in section 2(d)(2)(B) of the Improving Medicare PostAcute 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).

category in this proposed rule were also identified in the 2016 NASEM report19 or the 2020
NASEM report20 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.
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

19 Social Determinants of Health. Healthy People 2020. https;//www.healthypeople.gov/2020/gopicsobjectives/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.
21 Centers for Medicare & Medicaid Services. “A Guide to Using the Accountable Health Communities HealthRelated 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-EvidenceReview.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-healthlexicon-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-healthlexicon-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

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.
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

for Planning and Evaluation) Office of Health Policy. Report HP-2022-12 April 1, 2022. SDOH-EvidenceReview.pdf (hhs.gov). Accessed 5/29/2024.
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.
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.

underlie the country's health system is one of our strategic pillars29 and a Biden-Harris
Administration priority.30
3. Proposal to Collect Four New Items as Standardized Patient Assessment Data Elements
Beginning January 1, 2027, for the CY 2027 HH QRP Program Year31
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

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-gohere-strategic-vision-cms.
30 The White House. The Biden-⁠Harris Administration Immediate Priorities.
https://www.whitehouse.gov/priorities/.
31 Per the authority for the OASIS assessment instrument under 1891(d)(1), Home Health Conditions of
Participation [42 U.S.C. 1395bbb].
32 Centers for Medicare & Medicaid Services. “A Guide to Using the Accountable Health Communities HealthRelated 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-HealthRelated-Social-Needsin-Clinical-Settings.pdf.

assistance needs; and (5) interpersonal safety concerns (for example, intimate-partner violence,
elder abuse, child maltreatment).34
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.
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

34 More information about the AHC HRSN Screening Tool is available on the website at
https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf.
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).
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.

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 accessibility44. 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

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.

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.
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 Tool47,48 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 webpage at
https://www.cms.gov/medicare/quality/home-health/home-health-quality-measures.
b. Food

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-healthrelated-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.
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/.

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 foodinsecure 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
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-us/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-issuefor-older-adults-1.pdf.

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
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 webpage at
https://www.cms.gov/medicare/quality/home-health/home-health-quality-measures.

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
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/201907/ROI-EVIDENCE-REVIEW-FINAL-VERSION.pdf.
58 More information about the HFSS tool can be found at https://www.ers.usda.gov/topics/food-nutritionassistance/food-security-in-the-u-s/survey-tools/.
59 Hernández 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.

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 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

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 Hernández. "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 Hernández. "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 Hernández 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.

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
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

66 Siegel, Eva Laura, Kathryn Lane, Ariel Yuan, Lauren A. Smalls-Mantey, Jennifer Laird, Carolyn Olson, and
Diana Hernández. "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)  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/howto-make-it-easier-for-older-adults-to-get-energy-and-utility-assistance.
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.

can be found in the downloads section of the HH QRP Quality Measures webpage at
https://www.cms.gov/medicare/quality/home-health/home-health-quality-measures.
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 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.
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 webpage 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

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.

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.
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.

72 E:\PUBLAW\PUBL173.108 (congress.gov).

● 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.
F. Form, Manner, and Timing of Data Submission under the HH QRP
1. Background
We refer readers to the regulatory text at § 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 webpage 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.
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 measure76 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

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.
73 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.
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
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-assessmentinstruments/mms/downloads/composite-measures.pdf.
76 CMS Measures Inventory Tool. Adult immunization status measure found at
https://cmit.cms.gov/cmit/#/FamilyView?familyId=26.

for Depression and Follow-up measure77 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 measure78 included in the Universal Foundation of Quality Measures.
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.

77 Preventative Care and Screening: Screening for Depression and Follow Up measure found at
https://qpp.cms.gov/docs/QPP_quality_measure_specifications/CQMMeasures/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 .

IV. The Expanded Home Health Value-Based Purchasing (HHVBP) Model
A. Background
As authorized by section 1115A of the Act and finalized in the CY 2016 HH PPS final
rule (80 FR 68624), the Center for Medicare and Medicaid Innovation (Innovation Center)
implemented the Home Health Value-Based Purchasing (HHVBP) Model (“original Model”) in
nine states on January 1, 2016. The design of the original HHVBP Model leveraged the
successes and lessons learned from other CMS value-based purchasing programs and
demonstrations to shift from volume-based payments to a model designed to promote the
delivery of higher quality care to Medicare beneficiaries. The specific goals of the original
HHVBP Model were to-● Provide higher incentives for better quality care with greater efficiency;
● Study new potential quality and efficiency measures for appropriateness in the home
health setting; and
● Enhance the current public reporting process.
The original HHVBP Model resulted in an average 4.6 percent improvement in HHAs'
total performance scores (TPS) and an average annual savings of $141 million to Medicare
without evidence of adverse risks.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

79
https://innovation.cms.gov/data-and-reports/2020/hhvbp-thirdann-rpt.
https://www.cms.gov/files/document/certificationhome-health-value-based-purchasing-hhvbpmodel.pdf.

On January 8, 2021, CMS announced the certification of the HHVBP Model for
expansion nationwide, as well as the intent to expand the Model through notice and comment
rulemaking.81
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, §§ 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:
● 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.

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

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

83 For more details on the GUIDE Model, see the Model webpage
(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).
84 https://oig.hhs.gov/oei/reports/OEI-05-22-00290.asp.

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 selfcare/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 orders85 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

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.”

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
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.

86 https://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
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/keyconcepts/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 patientreported care experiences. Improving the quality of care for these underserved communities is an
important quality improvement goal under the expanded HHVBP Model.
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 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

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., Jarrín, 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.
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., Jarrín, 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.

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
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

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: 239246. https://doi.org/10.1111/jgs.15082.

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 § 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 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

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.

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.
3. Legislative Summary
Section 642 of the Medicare Prescription Drug, Improvement, and Modernization Act of
2003 (Pub. L. 108-173) amended section 1861 of the Act to provide Medicare Part B coverage of
the IVIG product for the treatment of PIDD in the home, but not the items and services involved
with administration.
Section 101 of the Medicare IVIG Access and Strengthening Medicare and Repaying
Taxpayers Act of 2012 (Medicare IVIG Access Act) (Pub. L. 112-242) mandated the
establishment, implementation, and evaluation of a 3-year Medicare Intravenous Immune
Globulin (IVIG) Demonstration Project (the Demonstration) under Part B of title XVIII of the
Act. The Demonstration was implemented to evaluate the benefits of providing coverage and
payment for items and services needed for the home administration of IVIG for the treatment of
PIDD, and to determine if it would improve access to home IVIG therapy for patients with
PIDD. The Medicare IVIG Access Act mandated that Medicare would establish a per visit
payment amount for the items and services necessary for the home administration of IVIG
therapy for beneficiaries with specific PIDD diagnoses. The Demonstration did not include
Medicare payment for the IVIG product which continues to be paid under Part B in accordance
with 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
On September 28, 2017, Congress passed the Disaster Tax Relief and Airport and Airway

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.
Extension Act of 2017 (Pub. L. 115-63). Section 302 of Pub. L. 115-63 extended the
Demonstration through December 31, 2020.
Division CC, section 104, of the Consolidated Appropriations Act, 2021 (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 § 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 § 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 §§ 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 § 410.10(y) to add “items and services”.
Furthermore, sub-regulatory guidance documents (that is, IVIG LCD (33610)97 and IVIG Policy
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

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-coveragedatabase/view/lcd.aspx?LCDId=33610&ContrId=389.

functioning of a malformed body member, and 3) meet all other applicable Medicare statutory
and regulatory requirements. Policy guidance for the LCD for IVIG100 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.
TABLE 40: ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY
FOR HOME IVIG
Code
D80.0
D80.2
D80.3
D80.4
D80.5
D80.6
D80.7
D81.0
D81.1
D81.2
D81.5
D81.6
D81.7
D81.82
D81.89
D81.9
D82.0
D82.1
D82.4
D83.0
D83.1
D83.2
D83.8
D83.9
G11.3

Description
Hereditary hypogammaglobulinemia
Selective deficiency of immunoglobulin A [IgA]
Selective deficiency of immunoglobulin G [IgG] subclasses
Selective deficiency of immunoglobulin M [IgM]
Immunodeficiency with increased immunoglobulin M [IgM]
Antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia
Transient hypogammaglobulinemia of infancy
Severe combined immunodeficiency [SCID] with reticular dysgenesis
Severe combined immunodeficiency [SCID] with low T- and B-cell numbers
Severe combined immunodeficiency [SCID] with low or normal B-cell numbers
Purine nucleoside phosphorylase [PNP] deficiency
Major histocompatibility complex class I deficiency
Major histocompatibility complex class II deficiency
Activated Phosphoinositide 3-kinase Delta Syndrome [APDS]
Other combined immunodeficiencies
Combined immunodeficiency, unspecified
Wiskott-Aldrich syndrome
Di George's syndrome
Hyperimmunoglobulin E [IgE] syndrome
Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function
Common variable immunodeficiency with predominant immunoregulatory T-cell disorders
Common variable immunodeficiency with autoantibodies to B- or T-cells
Other common variable immunodeficiencies
Common variable immunodeficiency, unspecified
Cerebellar ataxia with defective DNA repair

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

100 https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52509.

CAA, 2023 to reflect the expansion of the benefit to the items and services related to the home
administration of IVIG. Leveraging the existing regulations and sub-regulatory guidance
maintains one set of standards across the entire IVIG benefit (that is, for the product and for the
related items and services needed for home administration).
1. Items and Services Related to the Home Administration of IVIG
Section 101(c) of the Medicare IVIG Access Act established coverage for items and
services needed for the in-home administration of IVIG for the treatment of primary
immunodeficiencies under a Medicare demonstration program. In the CY 2024 HH PPS final
rule, we stated that we interpreted section 4134 of the CAA, 2023 to make permanent coverage
of the same items and services under the existing IVIG Demonstration to promote continuous
and comprehensive coverage for beneficiaries who choose to receive home IVIG therapy (88 FR
77794). Under the Demonstration, the bundled payment for the items and services necessary to
administer the drug intravenously in the home included the infusion set and tubing, and nursing
services to complete an infusion of IVIG lasting on average three to five hours.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

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.

(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.
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

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33794.

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,

103 Local

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

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.
C. Home IVIG Administration Items and Services Payment
Section 101 of the Medicare IVIG Access Act established the authority for a
Demonstration providing payment for items and services needed for the in-home administration
of IVIG. In the CY 2024 HH PPS final rule, we stated that we believed the provisions
established under that law serve as the basis for the conditions for payment with respect to the
requirements that must be met for Medicare payment to be made to suppliers for the items and
services covered under section 1861(s)(2)(Z) of the Act and clarified that the relevant regulations
and subregulatory guidance also apply.
1. Home IVIG Administration Items and Services Supplier Type
Section 4134(b) of the CAA, 2023 amends section 1842(o) of the Act by adding a new
paragraph (8) that establishes a separate bundled payment to the supplier for all items and
services related to the administration of such intravenous immune globulin, described in section
1861(s)(2)(Z) of the Act to such individual in the patient’s home during a calendar day. Section
4134(c) of the CAA, 2023 amends section 1834(j)(5) of the Act, which are a requirement for
supplier of medical equipment and supplies, by adding a new subparagraph (E), clarifying with
respect to payment, that items and services related to the administration of intravenous immune
globulin furnished on or after January 1, 2024, as described in section 1861(zz) of the Act, are
included in the definition of medical equipment and supplies. This means that suppliers that
furnish IVIG administration items and services must meet the existing 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 § 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 § 410.38(b).
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

104 Intravenous

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

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 § 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 § 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 § 414.1700(c) to annually update the CY 2025 home IVIG
items and services payment rate and subsequent years, by the home health payment rate update
percentage for such year. Therefore, 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) webpage
(found at https://www.cms.gov/medicare/payment/fee-for-service-providers/home-infusiontherapy) 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 webpage.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).

https://www.cms.gov/medicare/payment/fee-for-service-providers/home-infusion-therapy.

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 (§ 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 § 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 § 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,

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8197411/, date accessed 5-7-24.
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.
107 Amol

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
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 immediate prior hospitalization, those who are self-referrals or referred by a communitybased 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

Assessment of Receipt of the First Home Health Care Visit After Hospital Discharge Among Older Adults. Jun
Li, PhD, Mingyu Qi, MS, and Rachel M. Werner , PhD, 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.
110 Social Vulnerability and Medical Complexity Among Medicare Beneficiaries Receiving Home Health Without
Prior Hospitalization, Julia G. Burgdorf, PhD, Tracy M. Mroz, OTR/L, PhD, and Jennifer L. Wolff, PhD. Innovation
in Aging, 2020, Vol. 4, No. 6, 1–9 doi:10.1093/geroni/igaa049.
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.
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 needs111,112 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 § 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,

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-strandpatients/. 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.
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.
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
§ 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 § 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 § 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 § 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, 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 § 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 § 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
§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 § 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 § 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 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
increasing113,114 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 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”

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-settingswellsky-report#:~:text=Patients%20in%20the%20hospital%20are,post%2Dacute%20settings%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-settingswellsky-report#:~:text=Patients%20in%20the%20hospital%20are,post%2Dacute%20settings%20more%20difficult.
118 https://www.fiercehealthcare.com/providers/hospitals-struggling-discharge-patients-post-acute-care-settingswellsky-report#:~:text=Patients%20in%20the%20hospital%20are,post%2Dacute%20settings%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%20
United,In%202018%2C%20Young%20et%20al.
121 https://josr-online.biomedcentral.com/articles/10.1186/s13018-023-03750-4.

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
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?

122 https://homehealthcarenews.com/2024/01/home-health-agencies-grapple-with-acuity-creep-as-patient-needsbecome-more-complex/.

● 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 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 § 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 LongTerm 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 § 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 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 requirements124), 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.
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

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-omnibuscovid-19-health-care-staff-vaccination.
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-200000residents-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/sr03047.pdf).

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
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.
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

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

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.
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

132 https://www.govinfo.gov/content/pkg/FR-2024-05-10/pdf/FR-2024-05-10.pdf.

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 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, datadriven approaches have helped to inform and direct action throughout the health care ecosystem,
ultimately improving resident care and outcomes.
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

133 https://aspr.hhs.gov/HealthCareReadiness/StoriesfromtheField/Pages/Stories/Kentucky-CollaboratesCommunity.aspx.
134 https://aspr.hhs.gov/HealthCareReadiness/HealthCareReadinessNearYou/Documents/HCC-FactSheetApril2021-508.pdf.
135 https://aspr.hhs.gov/HealthCareReadiness/HealthCareReadinessNearYou/Documents/HCC-FactSheetApril2021-508.pdf.

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.
Additionally, since the start of the PHE, data reported under our requirements at
§ 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
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

136 Mitchell SH, Rigler J, Baum K. Regional Transfer Coordination and Hospital Load Balancing During COVID19 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.
138 Coverage with Influenza, Respiratory Syncytial Virus, and Updated COVID-19 Vaccines Among Nursing
Home Residents — National Healthcare Safety Network, United States, December 2023  MMWR (cdc.gov)
(https://www.cdc.gov/mmwr/volumes/72/wr/mm7251a3.htm).

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
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

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-fy2022-qio-rtc.pdf).
140 Protecting Nursing Home Residents from Covid-19: Federal Strike Team Findings and Lessons Learned 
NEJM Catalyst (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0144).

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, Pub. L. 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 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
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

141 https://doi.org/10.1111/jgs.18402.

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 disparities142and 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.
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,

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.

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
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

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.
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.

RSV has led to an overall hospitalization burden larger than observed during severe influenza
and RSV seasons prior to the COVID-19 pandemic.148
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 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.
Specifically, we propose to replace the existing reporting requirements for LTC facilities
at § 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

148 Respiratory Disease Season Outlook (cdc.gov) (https://www.cdc.gov/forecast-outbreak-analytics/about/seasonoutlook.html).
149 Respiratory Disease Season Outlook (cdc.gov) (https://www.cdc.gov/forecast-outbreak-analytics/about/seasonoutlook.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.

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.
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.

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  MMWR (cdc.gov)
(https://www.cdc.gov/mmwr/volumes/72/wr/mm7251a3.htm#F1_down).

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.
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 COVD-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.

154 Continued increases in the incidence of healthcare-associated infection (HAI) during the second year of the

coronavirus disease 2019 (COVID-19) pandemic  Infection Control & Hospital Epidemiology  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-lineassociated 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/).

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.
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.
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

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

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
§§ 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 § 424.510, one such requirement is that the provider or supplier must
complete, sign, and submit to its assigned Medicare Administrative Contractor (MAC) the
appropriate enrollment form, typically the Form CMS-855 (OMB Control No. 0938-0685). The
Form CMS-855, which can be submitted via paper or electronically through the Internet-based
Provider Enrollment, Chain, and Ownership System (PECOS) process (System of Records notice
(SORN): 09-70-0532, PECOS), collects important information about the provider or supplier.
Such data includes, but is not limited to, general identifying information (for example, legal
business name), licensure and/or certification data, ownership information, and practice
locations. The application is used for a variety of provider enrollment transactions, including the
following:

● Initial enrollment – The provider or supplier is -- (1) enrolling in Medicare for the first
time; (2) enrolling in another Medicare contractor's jurisdiction; or (3) seeking to enroll in
Medicare after having previously been enrolled.
● Change of ownership – The provider or supplier is reporting a change in its ownership.
● Revalidation – The provider or supplier is revalidating its Medicare enrollment
information in accordance with § 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 § 424.540.
● Change of information – The provider or supplier is reporting a change in its existing
enrollment information in accordance with § 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-hospicesarizona-california-nevada-texas.pdf for more information.)
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 § 424.527(a) in the
CY 2024 HH PPS final rule to address this issue. Specifically, new § 424.527(a)(1) through (3)

159 CMS

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

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 § 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
§ 424.550(b)(2) for an exception from the change in majority ownership requirements in
§ 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 § 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 § 424.527(a).
Under § 424.540 and the definition of “deactivate” in § 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
§ 424.527(a). Although a deactivation does not rise to the level of a revocation of Medicare
enrollment and billing privileges under § 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 § 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 (§ 424.540(a)(2));
● Failing to timely respond to a revalidation request (§ 424.540(a)(3));
● Failing to maintain compliance with all enrollment requirements (§ 424.540(a)(4));
and
● Having a non-operational or otherwise invalid practice location (§ 424.540(a)(5)).
The provider or supplier can also be revoked under § 424.535(a) on any of these bases
(for instance, under § 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, § 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 § 424.540(a)(1) would help prevent improper activity and help ensure program
integrity where the PPEO applies.
Deactivation can also occur under § 424.540 if: (1) the provider or supplier is voluntarily
withdrawing from the Medicare program (that is, voluntarily terminating its Medicare
enrollment) (§ 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 § 424.550(b) (§ 424.540(a)(8)); or (3)
an individual provider or supplier is deceased (§ 424.540(a)(6)). The same concerns we
expressed regarding reactivations following a § 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 § 424.527 that
includes providers and suppliers that are reactivating their enrollment and billing privileges
under § 424.540(b). We have elected to address this issue via rulemaking in proposed
§ 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 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.
TABLE 41: U.S. BUREAU OF LABOR STATISTICS’ MAY 2023 NATIONAL
OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES

Occupation Title
Registered Nurse (RN)
Physical therapists (PT)
Speech-Language Pathologists (SLP)
Occupational Therapists (OT)
Miscellaneous Health Technologists and Technicians

Occupation
Code
29-1141
29-1123
29-1127
29-1122
29-2090

Median
Hourly Wage
($/hr)
$41.38

Fringe Benefit
(100%)
($/hr)
$41.38

Adjusted Hourly
Wage ($/hr)
$82.76

$47.94
$42.93
$46.33
$29.05

$47.94
$42.93
$46.33
$29.05

$95.88
$85.86
$92.66
$58.10

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
0.7714×82.76+0.2216×95.98+0.007×89.26= 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).
TABLE 42. START OF CARE/RESUMPTION OF CARE OASIS SUBMISSIONS
BASED ON CY 2023 & CY 2025 ESTIMATED OASIS DATA

Time Point
Start of Care
Resumption of Care
Total Assessments

CY 2023 OASIS
Assessments Completed
6,627,912
911,245
7,539,157

Estimated CY 2025 OASIS
Assessments Based on AllPayer Data Collection
8,616,286
1,184,618
9,800,904

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.
● 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.
TABLE 43. SUMMARY OF ESTIMATED CLINICIAN HOURLY BURDEN FOR CY
2025 AND CY 2027

OASIS Assessment Type
Start of Care
Resumption of Care
Totals

Clinician Estimated
SOC/ROC Hourly
Burden – OASIS 2025
8,099,309
929,925
9,029,234

Clinician Estimated
SOC/ROC Hourly
Burden – OASIS 2027
8,228,553
947,694
9,176,247

Total Increase in
Hours
+129,244
+17,769
+147,013

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.
TABLE 44. SUMMARY OF ESTIMATED CLINICIAN COSTS FOR CY 2025 AND CY

2027
OASIS
Assessment Type
Start of Care
Resumption of Care
Totals

Clinician Estimated
Cost – OASIS-E1 2025
$ 694,434,753.66
$ 79,731,769.50
$ 774,166,523.16

Clinician Estimated
Cost – OASIS 2027
$ 705,516,134.22
$ 81,255,283.56
$ 786,771,417.78

Total Cost Increase
+$11,081,380.56
+$1,523,514.06
+$12,604,894.62

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 (§ 484.105)
In section VII.A. of this proposed rule, we discuss our proposal to add a new standard at
§ 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 5/60minute= $6.90) or $65,999 for all HHAs
($6.90 x 9,565= $65,999) to fulfill this requirement.
TABLE 45: U.S. BUREAU OF LABOR STATISTICS’ MAY 2023 NATIONAL
OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES

Occupation Title
Registered Nurse (RN)
https://www.bls.gov/oes/current/oes291141.htm
Physician
https://www.bls.gov/oes/current/oes291229.htm
Medical Administrative Assistant
https://www.bls.gov/oes/current/oes436013.htm

Occupation
Code

Median
Hourly
Wage
($/hr)
$41.38

Fringe
Benefit
(100%)
($/hr)
$41.38

Adjusted
Hourly Wage
($/hr)
$82.76

$119.54

$119.54

$239.08

$20.85

$20.85

$41.70

29-1141
29-1229
46-6013

TABLE 46: SUMMARY OF ESTIMATED COSTS FOR THE ACCEPTANCE TO
SERVICE POLICY
Estimated Burden § 484.105:
Acceptance to Service Policy

82.76
$239.08
$321,84(one time cost)
$6.90 (annually)
$10.43 (one time cost)
$3.48 (annually)

Total
Number of
HHA’s

9,565
9,565
9,565
9,565
9,565
9,565

Net Total

$791,599
$2,286,800
$3,078,400
$65,999
$99,763
$33,286

In addition, we estimate this proposed new requirement would take 15 minutes on a onetime 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
suppliers--as the Secretary determines appropriate, including categories of providers or
suppliers--will be subject to enhanced oversight. These procedures have been codified in §
424.527. As explained in section VII. of this proposed rule, we are proposing to expand the
definition of “new provider or supplier” in § 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 § 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 §483.80(g)
The ICR burden currently associated with §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 §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
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

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

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 facility annually. We will submit the revised
information collection request to OMB for approval under OMB control number 0938-1363.
TABLE 47: TOTAL BURDEN FOR § 483.80(g) ICRs

LTC Requirements
Section
§483.80(g)(1) and (2)
Policies and Procedures
§483.80(g)(1) and (2)
Electronically Reporting
Totals

Number
of LTC
Facilities
14,926

Hourly
Wage
Rate
$91

Burden
Hours Per
LTC
Facility
Cost
Estimate
Per
LTC Facility
$182

Burden
Hours
For All
LTC Facilities
29,852

Cost
Estimate
For All
LTC Facilities
$2,716,532

14,926

$91

52 to 365

$4,732 to $33,215

776,152 to 5,447,990

$70,629,832 to $495,767,090

14,926

$91

54 to 367

$4,914 to $33,397

806,004 to 5,477,842

$73,346,364 to $498,483,622

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 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 § 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 § 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 § 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. 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.

TABLE 48: CY 2025 HHA IMPACTS BY FACILITY TYPE AND AREA OF THE COUNTRY

All Agencies
Facility Type and Control
Free-Standing/Other Vol/NP
Free-Standing/Other Proprietary
Free-Standing/Other Government
Facility-Based Vol/NP
Facility-Based Proprietary
Facility-Based Government
Subtotal: Freestanding
Subtotal: Facility-based
Subtotal: Vol/NP
Subtotal: Proprietary
Subtotal: Government
Facility Type and Control: Rural
Free-Standing/Other Vol/NP
Free-Standing/Other Proprietary
Free-Standing/Other Government
Facility-Based Vol/NP
Facility-Based Proprietary
Facility-Based Government
Facility Type and Control: Urban
Free-Standing/Other Vol/NP
Free-Standing/Other Proprietary
Free-Standing/Other Government
Facility-Based Vol/NP
Facility-Based Proprietary
Facility-Based Government
Facility Location: Urban or Rural
Rural
Urban
Facility Location: Region of the
Country (Census Region)
New England
Mid Atlantic
East North Central
West North Central
South Atlantic

Number
of
Agencies
9,565

Permanent
Adjustment
-3.6%

CY 2025
Case-Mix
Weights
Recalibration
Neutrality
Factor
0.0%

CY 2025
Updated
Wage Index
(with 5% cap
and OMB
Delineations)
0.0%

CY 2025
Proposed
LUPA
Add-On
Factors
Update
0.0%

CY 2025
Proposed
HH
Payment
Update
Percentage
2.5%

FixedDollar
Loss
(FDL)
Update
-0.6%

Total
-1.7%

865
7,029
149
429
44
137
8,043
610
1,294
7,073
-3.5%
-3.7%
-3.6%
-3.4%
-3.6%
-3.5%
-3.6%
-3.4%
-3.5%
-3.7%
-3.5%

0.0%
0.0%
0.0%
0.0%
0.2%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%

-0.5%
0.2%
0.3%
-0.4%
0.6%
0.3%
0.1%
-0.2%
-0.5%
0.2%
0.3%

0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%

2.5%
2.5%
2.5%
2.5%
2.5%
2.5%
2.5%
2.5%
2.5%
2.5%
2.5%

-0.7%
-0.5%
-0.7%
-0.9%
-0.5%
-0.7%
-0.6%
-0.8%
-0.8%
-0.5%
-0.7%

-2.2%
-1.5%
-1.5%
-2.2%
-0.8%
-1.4%
-1.6%
-1.9%
-2.3%
-1.5%
-1.4%

205
731
101
187
14
-3.5%
-3.7%
-3.5%
-3.4%
-3.8%
-3.5%

0.1%
0.2%
0.2%
0.1%
0.5%
0.1%

0.7%
1.5%
0.9%
0.8%
-0.6%
0.4%

0.0%
0.0%
0.0%
0.0%
0.0%
0.0%

2.5%
2.5%
2.5%
2.5%
2.5%
2.5%

-0.7%
-0.4%
-0.8%
-0.9%
-0.4%
-0.9%

-0.9%
0.1%
-0.7%
-0.9%
-1.8%
-1.4%

660
6,290
48
242
30
-3.5%
-3.7%
-3.6%
-3.4%
-3.6%
-3.5%

0.0%
0.0%
-0.1%
-0.1%
0.1%
-0.1%

-0.7%
0.1%
-0.1%
-0.6%
0.9%
0.2%

0.0%
0.0%
0.0%
0.0%
0.0%
0.0%

2.5%
2.5%
2.5%
2.5%
2.5%
2.5%

-0.7%
-0.5%
-0.6%
-0.9%
-0.6%
-0.7%

-2.4%
-1.6%
-1.9%
-2.5%
-0.7%
-1.6%

1,338
7,307

-3.7%
-3.6%

0.2%
0.0%

1.2%
-0.1%

0.0%
0.0%

2.5%
2.5%

-0.5%
-0.6%

-0.3%
-1.8%

298
376
1,418
567
1,546

-3.5%
-3.6%
-3.6%
-3.5%
-3.6%

-0.1%
-0.1%
0.0%
0.0%
0.0%

-1.4%
-1.2%
0.0%
0.9%
1.0%

0.0%
0.0%
0.0%
0.0%
0.0%

2.5%
2.5%
2.5%
2.5%
2.5%

-0.7%
-0.6%
-0.6%
-0.8%
-0.5%

-3.2%
-3.0%
-1.7%
-0.9%
-0.6%

East South Central
West South Central
Mountain
Pacific
Outlying
Facility Size (Number of 30-day
Periods)
< 100 periods
100 to 249
250 to 499
500 to 999
1,000 or More

Number
of
Agencies
357
1,985
702
2,273
Permanent
Adjustment
-3.7%
-3.7%
-3.6%
-3.6%
-3.7%

CY 2025
Case-Mix
Weights
Recalibration
Neutrality
Factor
0.2%
0.1%
-0.1%
0.0%
0.5%

2,177
1,520
1,693
1,891
2,284

-3.6%
-3.6%
-3.6%
-3.6%
-3.6%

0.1%
0.0%
0.0%
0.0%
0.0%

CY 2025
Updated
Wage Index
(with 5% cap
and OMB
Delineations)
2.2%
1.3%
1.3%
-1.9%
-1.2%

CY 2025
Proposed
LUPA
Add-On
Factors
Update
0.0%
0.0%
0.0%
0.0%
0.0%

CY 2025
Proposed
HH
Payment
Update
Percentage
2.5%
2.5%
2.5%
2.5%
2.5%

FixedDollar
Loss
(FDL)
Update
-0.4%
-0.6%
-0.7%
-0.6%
-0.5%

Total
0.8%
-0.4%
-0.6%
-3.6%
-2.4%

0.1%
-0.2%
-0.1%
0.0%
0.0%

0.0%
0.0%
0.0%
0.0%
0.0%

2.5%
2.5%
2.5%
2.5%
2.5%

-0.7%
-0.7%
-0.6%
-0.6%
-0.6%

-1.6%
-2.0%
-1.8%
-1.7%
-1.7%

Source: CY 2023 Medicare claims data for periods with matched OASIS records ending in CY 2023 (as of March 19, 2024).
Notes: The estimated 3.6 percent decrease related to the proposed permanent adjustment includes all payments, while the proposed -4.067 percent permanent adjustment only
applies to the national, standardized 30-day period payments and does not impact payments for 30-day periods which are LUPAs. The “Proposed Wage Index” column reflects
updated hospital wage index data (reflecting 2021 cost report data) with the revised OMB delineations from OMB Bulletin No. 23-01 and a 5-percent cap on wage index decreases.
The “Proposed LUPA Add-On Factors Update” column has an impact range of -0.01 percent to -0.035 percent which is reflected in the table as 0.0 percent due to rounding. “The
"Fixed Dollar Loss (FDL) Update" column reflects a change in the FDL from 0.27 to 0.38. Due to missing Provider of Services file information (from which home health agency
characteristics are obtained), some subcategories in the impact tables have fewer agencies represented than the overall total (of 9,565): totals involving facility type or control only
add up to 8,653 and totals involving urban/rural locations only add up to 8,645.
REGION KEY:
New England=Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont
Middle Atlantic=Pennsylvania, New Jersey, New York
South Atlantic=Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia
East North Central=Illinois, Indiana, Michigan, Ohio, Wisconsin
East South Central-Alabama, Kentucky, Mississippi, Tennessee
West North Central=Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota
West South Central=Arkansas, Louisiana, Oklahoma, Texas
Mountain=Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming
Pacific=Alaska, California, Hawaii, Oregon, Washington
Other=Guam, Puerto Rico, Virgin Islands

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.

TABLE 49: ESTIMATED COSTS OF COVERED IVIG ITEMS AND SERVICES,
CY 2025
Year

Number of Active
Enrollees1

Number of IVIG Visits1

Proposed
Nationwide Rate

Estimated Cost

CY 2025

1,933

21,892

$430.99

$9,435,233

1The

number of active enrollees and IVIG visits in CY 2023 was used to estimate utilization in CY 2024 and CY
2025. Claims data were extracted on March 20, 2024.

TABLE 50—ESTIMATED IMPACTS OF THE HOME IVIG ITEMS AND SERVICES
PAYMENT BY REGION, CY 2025

Region
New England
Middle Atlantic
South Atlantic
East North Central
East South Central
West North Central
West South Central
Mountain
Pacific
Other

States
CT, ME, MA, NH, RI, VT
NJ, NY, PA
DE, DC, FL, GA, MD, NC, SC, VA, WV
IL, IN, MI, OH, WI
AL, KY, MS, TN
IA, KS, MN, MO, NE, ND, SD
AR, LA, OK, TX
AZ, CO, ID, MT, NV, NM, UT, WY
AK, CA, HI, OR, WA
GU, PR, VI

Number of
Active
Enrollees1
175
219
504
159
190
136
196
148
214
Number of
IVIG
Visits1
2,232
2,593
5,220
1,803
2,051
1,591
2,168
1,696
2,538
Estimated
CY 2025
Cost
$961,970
$1,117,557
$2,249,768
$777,075
$883,960
$685,705
$934,386
$730,959
$1,093,853
$0

1The

number of active enrollees in the IVIG Demonstration and their IVIG visits in CY 2023 was used to estimate
utilization in CY 2025. CY 2023 claims data were extracted on March 20, 2024. Each IVIG claims is assigned to a
single census division. There are eight beneficiaries who had a set of IVIG claims in CY 2023 with a portion of
their claims in one census division and the remaining claims in a different census division.

5. HHA CoP Changes: Establishing an Acceptance to Service Policy
We propose to add a new standard § 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 § 424.527(a) to include providers and suppliers that are reactivating their
Medicare enrollment and billing privileges under § 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 § 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 § 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 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 × $106.42). Therefore, we estimate that the total cost of reviewing
this proposed rule is $279,451 ($294.78 × 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/wpcontent/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.
TABLE 51: ACCOUNTING STATEMENT: HH PPS CLASSIFICATION OF
ESTIMATED TRANSFERS AND BENEFITS, FROM CY 2024 TO CY 2025
Category
Annualized Monetized Transfers
Bearers of Transfer Gain

Transfers
-$280 million
Medicare HHAs

2. HH QRP
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wpcontent/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.
TABLE 52: HH QRP ESTIMATED COSTS FROM CY 2025 TO CY 2027
Category

Costs

The total economic impact of these proposals including the addition of one
Living Situation item, two Food items, and one Utilities item, and the
modification of the current Transportation item proposed for
implementation in CY 2027

$12,604,894.62 (2%
Discount Rate)

3. Home IVIG Items and Services
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wpcontent/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.
TABLE 53: ACCOUNTING STATEMENT: IVIG CLASSIFICATION OF ESTIMATED
TRANSFERS AND BENEFITS CY 2025
Category
Transfers
Annualized Monetized Transfers
$9.4 million*
Bearers of Transfer Gain
Medicare DMEPOS suppliers
*Reflects the CY 2025 aggregate transfer impact of the home IVIG items and services payments.
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 million161 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.

TABLE 54: NUMBER OF FIRMS, REVENUE, AND ESTIMATED IMPACT OF HOME
HEALTH CARE SERVICES BY NAICS CODE 621610

NAICS
Code
621610
621610
621610
621610
621610
621610
621610
621610
621610
621610
NAICS Description
Home Health Care Services
Home Health Care Services
Home Health Care Services
Home Health Care Services
Home Health Care Services
Home Health Care Services
Home Health Care Services
Home Health Care Services
Home Health Care Services
Home Health Care Services
Home Health Care Services

Enterprise Size
<100
100-499
500-999
1,000-2,499
2,500-4,999
5,000-7,499
7,500-9,999
10,000-14,999
15,000-19,999
≥20,000
Total

Number
of Firms
5,861
5,687
3,342
4,434
1,951
672
356
346
191
961
23,801

Receipts
($1,000)
210,697
1,504,668
2,430,807
7,040,174
6,657,387
3,912,082
2,910,943
3,767,710
2,750,180
51,776,636
82,961,284

Estimated
Average Impact
($1,000) per
Enterprise Size
$35.95
$264.58
$727.35
$1,587.77
$3,412.29
$5,821.55
$8,176.81
$10,889.34
$14,398.85
$53,877.87
$3,485.62

Source: Data obtained from United States Census Bureau table “us_6digitnaics_rcptsize_2017” (SOURCE: 2017 County
Business Patterns and Economic Census) Release Date: 5/28/2021: https://www2.census.gov/programs-surveys/susb/tables/2017/
Notes: Estimated impact is calculated as Receipts ($1,000)/Number of firms. For the total, this is the average estimated impact
across all number of firms.

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 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 $1,058.88per 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 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
1. The authority for part 424 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
2. Section 424.527 is amended by adding paragraph (a)(4) to read as follows:
§ 424.527 Provisional period of enhanced oversight.
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(4) A provider or supplier reactivating the provider’s or supplier’s Medicare enrollment
and billing privileges in accordance with § 424.540(b).
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PART 483—REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
3. The authority citation for part 483 continues to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r.
4. Section 483.80 is amended by revising paragraph (g) to read as follows:
§ 483.80 Infection control.
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(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
5. The authority citation for part 484 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.

6. Section 484.105 is amended by adding paragraph (i) to read as follows:
§ 484.105 Condition of participation: Organization and administration of services.
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(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: 6/26/2024 4:15 pm; Publication Date: 7/3/2024]