Rule2024-16910

Medicare Program; FY 2025 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, and Hospice Quality Reporting Program Requirements

Primary source

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Published
August 6, 2024
Effective
October 1, 2024

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This final rule updates the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2025. This rule also adopts the most recent Office of Management and Budget statistical area delineations, which will impact the hospice wage index. This rule clarifies current policy related to the "election statement" and the "notice of election", as well as adds clarifying language regarding hospice certification and includes a technical regulation text change to the Conditions of Participation (CoPs). This rule finalizes changes to the Hospice Quality Reporting Program. Finally, this rule summarizes comments received regarding potential implementation of a separate payment mechanism to account for high intensity palliative care services.

Full Text

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<title>Federal Register, Volume 89 Issue 151 (Tuesday, August 6, 2024)</title>
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[Federal Register Volume 89, Number 151 (Tuesday, August 6, 2024)]
[Rules and Regulations]
[Pages 64202-64273]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16910]



[[Page 64201]]

Vol. 89

Tuesday,

No. 151

August 6, 2024

Part IV





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Part 418





Medicare Program; FY 2025 Hospice Wage Index and Payment Rate Update, 
Hospice Conditions of Participation Updates, and Hospice Quality 
Reporting Program Requirements; Final Rule

Federal Register / Vol. 89 , No. 151 / Tuesday, August 6, 2024 / 
Rules and Regulations

[[Page 64202]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 418

[CMS-1810-F]
RIN 0938-AV29


Medicare Program; FY 2025 Hospice Wage Index and Payment Rate 
Update, Hospice Conditions of Participation Updates, and Hospice 
Quality Reporting Program Requirements

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

ACTION: Final rule.

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SUMMARY: This final rule updates the hospice wage index, payment rates, 
and aggregate cap amount for Fiscal Year (FY) 2025. This rule also 
adopts the most recent Office of Management and Budget statistical area 
delineations, which will impact the hospice wage index. This rule 
clarifies current policy related to the ``election statement'' and the 
``notice of election'', as well as adds clarifying language regarding 
hospice certification and includes a technical regulation text change 
to the Conditions of Participation (CoPs). This rule finalizes changes 
to the Hospice Quality Reporting Program. Finally, this rule summarizes 
comments received regarding potential implementation of a separate 
payment mechanism to account for high intensity palliative care 
services.

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

FOR FURTHER INFORMATION CONTACT: 
    For general questions about hospice payment policy, send your 
inquiry via email to: <a href="/cdn-cgi/l/email-protection#4820273b38212b2d382724212b31082b253b6620203b662f273e"><span class="__cf_email__" data-cfemail="670f0814170e040217080b0e041e27040a14490f0f1449000811">[email&#160;protected]</span></a>.
    For questions regarding the CAHPS[supreg] Hospice Survey, contact 
Lauren Fuentes at (410) 786-2290.
    For questions regarding the hospice conditions of participation 
(CoPs), contact Mary Rossi-Coajou at (410) 786-6051.
    For questions regarding the hospice quality reporting program, 
contact Jermama Keys at (410) 786-7778.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose

    This final rule updates the hospice wage index, payment rates, and 
cap amount for Fiscal Year (FY) 2025 as required under section 1814(i) 
of the Social Security Act (the Act). This rule also finalizes the 
adoption of the most recent Office of Management and Budget (OMB) 
statistical area delineations based on data collected during the 2020 
Decennial Census, which will result in changes to the hospice wage 
index. In addition, this rule finalizes the reorganization of the 
regulations to clarify current policy related to the ``election 
statement'' and the ``notice of election (NOE),'' and adds clarifying 
language regarding who can certify terminal illness and admit patients 
to hospice. This rule also summarizes comments solicited regarding a 
potential policy to account for the increased hospice costs of 
providing high intensity palliative care services.
    Additionally, this rule finalizes the Hospice Quality Reporting 
Program (HQRP) measures collected through a new collection instrument, 
the Hospice Outcomes and Patient Evaluation (HOPE); finalizes two HOPE-
based measures and lays out the planned trajectory for further 
development of this instrument; and provides updates on Health Equity, 
future quality measures (QMs), and public reporting requirements. We 
also acknowledge responses on the request for information on potential 
social determinants of health (SDOH) elements. Finally, this rule also 
finalizes changes to the Hospice Consumer Assessment of Healthcare 
Providers and Systems (Hospice CAHPS) Survey.

B. Summary of the Major Provisions

    Section III.A.1 of this final rule updates the hospice wage index 
and makes the application of the updated wage data budget neutral for 
all four levels of hospice care.
    Section III.A.2 of this final rule adopts the new OMB labor market 
delineations from the July 21, 2023, OMB Bulletin No. 23-01 based on 
data collected from the 2020 Decennial Census.
    Section III.A.3 of this final rule includes the final FY 2025 
hospice payment update percentage of 2.9 percent.
    Section III.A.4 of this final rule includes updates to hospice 
payment rates.
    Section III.A.5 of this final rule includes an update to the 
hospice cap amount for FY 2025 by the hospice payment update percentage 
of 2.9 percent.
    In section III.B of this final rule, we make clarifying changes to 
the hospice Conditions of Participation (CoPs) and adopt clarifying 
regulations text, with no change to current policy. This includes 
reorganizing the regulations to clearly identify the distinction 
between the ``election statement'' and the ``notice of election,'' as 
well as including clarifying text changes that align payment 
regulations and CoPs regarding who may certify terminal illness and 
determine admission to hospice care. This section also finalizes 
technical regulations text changes in the Medical Director CoP at Sec.  
418.102. In addition, we are making a technical correction in the 
personnel requirements at Sec.  418.114(b)(9), where we inadvertently 
used the term ``marriage and family counselor'' when the correct term 
is ``marriage and family therapist.''
    In section III.C of this final rule, we include a summary of 
comments received on a potential policy to account for higher hospice 
costs involved in the provision of high intensity palliative care 
treatments.
    Finally, in section III.D of this final rule, we finalize HOPE-
based process measures; finalize the HOPE instrument; discuss updates 
to potential future quality measures; and finalize changes to the 
CAHPS[supreg] Hospice Survey.

C. Summary of Impacts

    The overall economic impact of this final rule is estimated to be 
$790 million in increased payments to hospices in FY 2025.

II. Background

A. Hospice Care

    Hospice care is a comprehensive, holistic approach to treatment 
that recognizes the impending death of a terminally ill individual and 
warrants a change in the focus from curative care to palliative care 
for relief of pain and for symptom management. Medicare regulations 
define ``palliative care'' as patient and family-centered care that 
optimizes quality of life by anticipating, preventing, and treating 
suffering. Palliative care throughout the continuum of illness involves 
addressing physical, intellectual, emotional, social, and spiritual 
needs and to facilitate patient autonomy, access to information, and 
choice (42 CFR 418.3). Palliative care is at the core of hospice 
philosophy and care practices and is a critical component of the 
Medicare hospice benefit.
    The goal of hospice care is to help terminally ill individuals 
continue life with minimal disruption to normal activities while 
remaining primarily in the home environment. A hospice uses an 
interdisciplinary approach to deliver medical, nursing, social, 
psychological, emotional, and spiritual services through a 
collaboration of professionals and other caregivers, with the goal of 
making the beneficiary as physically

[[Page 64203]]

and emotionally comfortable as possible. Hospice is compassionate 
beneficiary and family/caregiver-centered care for those who are 
terminally ill.
    As referenced in our regulations at Sec.  418.22(b)(1), to be 
eligible for Medicare hospice services, the patient's attending 
physician (if any) and the hospice medical director must certify that 
the individual is ``terminally ill,'' as defined in section 
1861(dd)(3)(A) of the Act and our regulations at Sec.  418.3; that is, 
the individual has a medical prognosis that the individual's life 
expectancy is 6 months or less if the illness runs its normal course. 
The regulations at Sec.  418.22(b)(2) require that clinical information 
and other documentation that support the medical prognosis accompany 
the certification and be filed in the medical record with it. The 
regulations at Sec.  418.22(b)(3) require that the certification and 
recertification forms, or an addendum to the certification and 
recertification forms, include a brief narrative explanation of the 
clinical findings that support a life expectancy of 6 months or less.
    Under the Medicare hospice benefit, the election of hospice care is 
a patient choice and once a terminally ill patient elects to receive 
hospice care, a hospice interdisciplinary group is essential in the 
seamless provision of primarily home-based services. The hospice 
interdisciplinary group works with the beneficiary, family, and 
caregivers to develop a coordinated, comprehensive care plan; reduce 
unnecessary diagnostics or ineffective therapies; and maintain ongoing 
communication with individuals and their families about changes in 
their condition. The beneficiary's care plan will shift over time to 
meet the changing needs of the individual, family, and caregiver(s) as 
the individual approaches the end of life.
    If, in the judgment of the hospice interdisciplinary group (as 
specified at Sec.  418.56(a)(1)), which includes the hospice physician, 
the patient's symptoms cannot be effectively managed at home, then the 
patient is eligible for general inpatient care (GIP), a more medically 
intense level of care. GIP must be provided in a Medicare-certified 
hospice freestanding facility, skilled nursing facility, or hospital. 
GIP is provided to ensure that any new or worsening symptoms are 
intensively addressed so that the beneficiary can return home for 
hospice care (routine home care) (RHC). Limited, short-term, 
intermittent, inpatient respite care (IRC) is also available because of 
the absence or need for relief of the family or other caregivers. 
Additionally, an individual can receive continuous home care (CHC) 
during a period of crisis in which an individual requires continuous 
care to achieve palliation or management of acute medical symptoms so 
that the individual can remain at home. CHC may be covered for as much 
as 24 hours a day, and these periods must be predominantly nursing 
care, in accordance with the regulations at Sec.  418.204. A minimum of 
8 hours of nursing care or nursing and aide care must be furnished on a 
particular day to qualify for the CHC rate (Sec.  418.302(e)(4)).
    Hospices covered by this rule must comply with applicable civil 
rights laws, including, section 504 of the Rehabilitation Act of 1973 
and the Americans with Disabilities Act, which require covered programs 
to take appropriate steps to ensure effective communication with 
individuals with disabilities and companions with disabilities, 
including the provisions of auxiliary aids and services when necessary 
to afford qualified individuals with disabilities, including 
applicants, participants, beneficiaries, companions and members of the 
public, an equal opportunity to participate in, and enjoy the benefits 
of, a service, program or activity of a recipient or public entity.\1\ 
Further information may be found at: <a href="https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html">https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html</a>.
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    \1\ Hospices receiving Medicare Part A funds or other federal 
financial assistance from the Department are also subject to 
additional federal civil rights laws, including the Age 
Discrimination Act, and are subject to conscience and religious 
freedom laws where applicable.
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    Title VI of the Civil Rights Act of 1964 prohibits discrimination 
on the basis of race, color or national origin in federally assisted 
programs or activities. The Office for Civil Rights (OCR) interprets 
this to require that recipients of Federal financial assistance take 
reasonable steps to provide meaningful access to their programs or 
activities to individuals with limited English proficiency (LEP).\2\ 
Similarly, section 1557's of the Affordable Care Act implementing 
regulation requires covered entities to take reasonable steps to 
provide meaningful access to LEP individuals in federally funded health 
programs and activities (45 CFR 92.201(a)). Meaningful access may 
require the provision of interpreter services and translated materials 
(45 CFR 92.201(c)).\3\
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    \2\ HHS OCR, Guidance to Federal Financial Assistance Recipients 
Regarding Title VI Prohibition Against National Origin 
Discrimination Affecting Limited English Proficient Persons, 68 Fed. 
Reg 47311 (Aug. 8, 2003), <a href="https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/guidance-federal-financial-assistance-recipients-title-vi/index.html">https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/guidance-federal-financial-assistance-recipients-title-vi/index.html</a>.
    \3\ The Section 1557 final rule has been challenged in several 
courts and is not currently in effect in Texas and Montana. 
Additional information about the rule is available here: Section 
1557 of the Patient Protection and Affordable Care Act [verbar] 
<a href="http://HHS.gov">HHS.gov</a>.
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B. Services Covered by the Medicare Hospice Benefit

    Coverage under the Medicare hospice benefit requires that hospice 
services must be reasonable and necessary for the palliation and 
management of the terminal illness and related conditions. Section 
1861(dd)(1) of the Act establishes the services that are to be rendered 
by a Medicare-certified hospice program. These covered services 
include: nursing care; physical therapy; occupational therapy; speech-
language pathology therapy; medical social services; home health aide 
services (called hospice aide services); physician services; homemaker 
services; medical supplies (including drugs and biological products); 
medical appliances; counseling services (including dietary counseling); 
short-term inpatient care in a hospital, nursing facility, or hospice 
inpatient facility (including both respite care and care and procedures 
necessary for pain control and acute or chronic symptom management); 
continuous home care during periods of crisis, and only as necessary, 
to maintain the terminally ill individual at home; and any other item 
or service which is specified in the plan of care and for which payment 
may otherwise be made under Medicare, in accordance with Title XVIII of 
the Act.
    Section 1814(a)(7)(B) of the Act requires that a written plan for 
providing hospice care to a beneficiary, who is a hospice patient, be 
established before care is provided by, or under arrangements made by, 
the hospice program; and that the written plan be periodically reviewed 
by the beneficiary's attending physician (if any), the hospice medical 
director, and an interdisciplinary group (section 1861(dd)(2)(B) of the 
Act). The services offered under the Medicare hospice benefit must be 
available to beneficiaries as needed, 24 hours a day, 7 days a week 
(section 1861(dd)(2)(A)(i) of the Act).
    Upon the implementation of the hospice benefit, Congress also 
expected hospices to continue to use volunteer services, although 
Medicare does not pay for these volunteer services (section 
1861(dd)(2)(E) of the Act). As stated in the Health Care Financing 
Administration's (now Centers for

[[Page 64204]]

Medicare & Medicaid Services (CMS)) proposed rule ``Medicare Program; 
Hospice Care (48 FR 38149), the hospice must have an interdisciplinary 
group composed of paid hospice employees as well as hospice volunteers, 
and that ``the hospice benefit and the resulting Medicare reimbursement 
is not intended to diminish the voluntary spirit of hospices.'' This 
expectation supports the hospice philosophy of community based, 
holistic, comprehensive, and compassionate end of life care.

C. Medicare Payment for Hospice Care

    Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of 
the Act, and the regulations in 42 CFR part 418, establish eligibility 
requirements, payment standards and procedures; define covered 
services; and delineate the conditions a hospice must meet to be 
approved for participation in the Medicare program. Part 418, subpart 
G, provides for a per diem payment based on one of four prospectively 
determined rate categories of hospice care (RHC, CHC, IRC, and GIP), 
based on each day a qualified Medicare beneficiary is under hospice 
care (once the individual has elected the benefit). This per diem 
payment is meant to cover all hospice services and items needed to 
manage the beneficiary's care, as required by section 1861(dd)(1) of 
the Act.
    While payment made to hospices is to cover all items, services, and 
drugs for the palliation and management of the terminal illness and 
related conditions, federal funds cannot be used for prohibited 
activities, even in the context of a per diem payment. For example, 
hospices are prohibited from playing a role in medical aid in dying 
(MAID) where such practices have been legalized in certain States. The 
Assisted Suicide Funding Restriction Act of 1997 (Pub. L. 105-12, April 
30, 1997) prohibits the use of federal funds to provide or pay for any 
health care item or service or health benefit coverage for the purpose 
of causing, or assisting to cause, the death of any individual 
including ``mercy killing, euthanasia, or assisted suicide.'' However, 
the prohibition does not pertain to the provision of an item or service 
for the purpose of alleviating pain or discomfort, even if such use may 
increase the risk of death, so long as the item or service is not 
furnished for the specific purpose of causing or accelerating death.
    The Medicare hospice benefit has been revised and refined since its 
implementation after various Acts of Congress and Medicare rules. For a 
historical list of changes and regulatory actions, we refer readers to 
the background section of previous Hospice Wage Index and Payment Rate 
Update rules.\4\
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    \4\ Hospice Regulations and Notices. <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Regulations-and-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Regulations-and-Notices</a>.
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III. Provisions of the Final Rule

A. Final FY 2025 Hospice Wage Index and Rate Update

1. Final FY 2025 Hospice Wage Index
    The hospice wage index is used to adjust payment rates for hospices 
under the Medicare program to reflect local differences in area wage 
levels, based on the location where services are furnished. Our 
regulations at Sec.  418.306(c) require each labor market to be 
established using the most current hospital wage data available, 
including any changes made by the Office of Management and Budget (OMB) 
to Metropolitan Statistical Area (MSA) definitions.
    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 September 14, 2018, OMB 
issued OMB Bulletin No. 18-04, which superseded the April 10, 2018, OMB 
Bulletin No. 18-03. OMB Bulletin No. 18-04 made revisions to the 
delineations of MSAs, Micropolitan Statistical Areas, and Combined 
Statistical Areas (CSA), and guidance on uses of the delineations in 
these areas. This bulletin provided the delineations of all MSAs, 
Metropolitan Divisions, Micropolitan Statistical Areas, CSAs, and New 
England City and Town Areas in the United States and Puerto Rico based 
on the standards published on June 28, 2010, in the Federal Register 
(75 FR 37246 through 37252), and Census Bureau data. A copy of the 
September 14, 2018, bulletin is available online at: <a href="https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf">https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf</a>. In 
the FY 2021 Hospice Wage Index final rule (85 FR 47080), we finalized 
our proposal to adopt the revised OMB delineations from the September 
14, 2018, OMB Bulletin 18-04 with a 5-percent cap on wage index 
decreases, where the estimated reduction in a geographic area's wage 
index would be capped at 5-percent in FY 2021 and no cap would be 
applied to wage index decreases for the second year (FY 2022). 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 the following website: 
<a href="https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf">https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf</a>). In OMB Bulletin No. 20-01, OMB announced one new Micropolitan 
Statistical Area, one new component of an existing CSA, and changes to 
New England City and Town Area (NECTA) delineations. In the FY 2021 
Hospice Wage Index final rule (85 FR 47070), 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 
determined that the changes in Bulletin 20-01 encompassed delineation 
changes that would not affect the Medicare wage index for FY 2022. 
Specifically, the updates consisted of changes to NECTA delineations 
and the redesignation of a single rural county into a newly created 
Micropolitan Statistical Area. The Medicare wage index does not utilize 
NECTA definitions, and, as most recently discussed in the FY 2021 
Hospice Wage Index final rule (85 FR 47070), we include hospitals 
located in Micropolitan Statistical Areas in each State's rural wage 
index.
    As described in the August 8, 1997, Hospice Wage Index final rule 
(62 FR 42860), the pre-floor and pre-reclassified hospital wage index 
is used as the raw wage index for the hospice benefit. These raw wage 
index values are subject to application of the hospice floor to compute 
the hospice wage index used to determine payments to hospices. As 
previously discussed, the pre-floor, pre-reclassified hospital wage 
index values below 0.8000 will be further adjusted by a 15 percent 
increase subject to a maximum wage index value of 0.8000. For example, 
if County A has a pre-floor, pre-reclassified hospital wage index value 
of 0.3994, we would multiply 0.3994 by 1.15, which equals 0.4593. Since 
0.4593 is not greater than 0.8000, then County A's hospice wage index 
would be 0.4593. In another example, if County B has a pre-floor, pre-
reclassified hospital wage index value of 0.7440, we would multiply 
0.7440 by 1.15, which equals 0.8556. Because 0.8556 is greater than 
0.8000,

[[Page 64205]]

County B's hospice wage index would be 0.8000.
    In the FY 2023 Hospice Wage Index final rule (87 FR 45673), we 
finalized for FY 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, so that a geographic area's wage 
index would not be less than 95 percent of its wage index calculated in 
the prior FY. When calculating the 5-percent cap on wage index 
decreases we start with the current fiscal year's pre-floor, pre-
reclassification hospital wage index value for a core-based statistical 
area (CBSA) or statewide rural area and if that wage index value is 
below 0.8000, we apply the hospice floor as discussed here. Next, we 
compare the current fiscal year's wage index value after the 
application of the hospice floor to the final wage index value from the 
previous fiscal year. If the current fiscal year's wage index value is 
less than 95 percent of the previous year's wage index value, the 5-
percent cap on wage index decreases would be applied and the final wage 
index value would be set equal to 95 percent of the previous fiscal 
year's wage index value. If the 5-percent cap is applied in one fiscal 
year, then in the subsequent fiscal year, that year's pre-floor, pre-
reclassification hospital wage index would be used as the starting wage 
index value and adjusted by the hospice floor. The hospice floor 
adjusted wage index value would be compared to the previous fiscal 
year's wage index which had the 5-percent cap applied. If the hospice 
floor adjusted wage index value for that fiscal year is less than 95 
percent of the capped wage index from the previous year, then the 5-
percent cap would be applied again, and the final wage index value 
would be 95 percent of the capped wage index from the previous fiscal 
year. Using the example previously stated, if County A has a pre-floor, 
pre-reclassified hospital wage index value of 0.3994, we would multiply 
0.3994 by 1.15, which equals 0.4593. If County A had a wage index value 
of 0.6200 in the previous fiscal year, then we would compare 0.4593 to 
the previous fiscal year's wage index value. Since 0.4593 is less than 
95 percent of 0.6200, then County A's hospice wage index would be 
0.5890, which is equal to 95-percent of the previous fiscal year's wage 
index value of 0.6200. In the next fiscal year, the updated wage index 
value would be compared to the wage index value of 0.5890.
    Previously, this methodology was applied to all the counties that 
make up the CBSA or rural area. However, as discussed in section 
III.A.2.f of this final rule, because we are adopting the revised OMB 
delineations this methodology will also be applied to individual 
counties.
    In the FY 2020 Hospice Wage Index final rule (84 FR 38484), we 
finalized the proposal to use the current FY's hospital wage index data 
to calculate the hospice wage index values. For FY 2025, we proposed 
that the hospice wage index would be based on the FY 2025 hospital pre-
floor, pre-reclassified wage index for hospital cost reporting periods 
beginning on or after October 1, 2020 and before October 1, 2021 (FY 
2021 cost report data). We also stated that the proposed FY 2025 
hospice wage index would not consider any geographic reclassification 
of hospitals, including those in accordance with section 1886(d)(8)(B) 
or 1886(d)(10) of the Act. The regulations that govern hospice payment 
do not provide a mechanism for allowing hospices to seek geographic 
reclassification or to utilize the rural floor provisions that exist 
for Inpatient Prospective Payment System (IPPS) hospitals. The 
reclassification provision found in section 1886(d)(10) of the Act is 
specific to hospitals. Section 4410(a) of the Balanced Budget Act of 
1997 (Pub. L. 105-33) provides that the area wage index applicable to 
any hospital that is located in an urban area of a State may not be 
less than the area wage index applicable to hospitals located in rural 
areas in that State. This rural floor provision is also specific to 
hospitals. Because the reclassification and the hospital rural floor 
policies apply to hospitals only, and not to hospices, we continue to 
believe the use of the pre-floor and pre-reclassified hospital wage 
index results is the most appropriate adjustment to the labor portion 
of the hospice payment rates. This position is longstanding and 
consistent with other Medicare payment systems, for example, the 
skilled nursing facility prospective payment system (SNF PPS), the 
inpatient rehabilitation facility prospective payment system (IRF PPS), 
and the home health prospective payment system (HH PPS). However, the 
hospice wage index does include the hospice floor, which is applicable 
to all CBSAs, both rural and urban. The hospice floor adjusts pre-
floor, pre-reclassified hospital wage index values below 0.8000 by a 15 
percent increase subject to a maximum wage index value of 0.8000. We 
proposed that the FY 2025 hospice wage index would also include the 5-
percent cap on wage index decreases. The appropriate wage index value 
would be applied to the labor portion of the hospice payment rate based 
on the geographic area in which the beneficiary resides when receiving 
RHC or CHC. The appropriate wage index value is applied to the labor 
portion of the payment rate based on the geographic location of the 
facility for beneficiaries receiving GIP or IRC.
    We received 28 comments on the proposed FY 2025 hospice wage index 
from various stakeholders including hospices, national industry 
associations, and the Medicare Payment Advisory Commission (MedPAC). A 
summary of these comments and our responses appear below:
    Comment: One commenter expressed concern with the wage index 
assigned to Montgomery County, Maryland (MD). This commenter stated 
that Montgomery County, MD has a similar cost of living compared to 
Washington, DC and shares the same labor market when competing for 
labor; therefore, hospices in Montgomery County should be reimbursed at 
the same level as hospices in Washington, DC This commenter stated that 
hospices in Montgomery County are at a long-term competitive 
disadvantage due to a Medicare hospice federal payment inequity 
involving CBSAs and recommended that CMS assign the hospice wage index 
valuation for the Washington, DC CBSA to the Montgomery/Frederick 
County CBSA for a time-limited period, such as 5 years, in order to 
evaluate the impact on Montgomery County hospices.
    Response: We thank the commenter for the recommendation. However, 
we continue to believe that the OMB's geographic area delineations 
represent a useful proxy for differentiating between labor markets and 
that the geographic area delineations are appropriate for use in 
determining Medicare hospice payments. The general concept of the CBSAs 
is that of an area containing a recognized population nucleus and 
adjacent communities that have a high degree of integration with that 
nucleus. The purpose of the 2020 standards for delineating Core Based 
Statistical Areas is to provide nationally consistent definitions for 
collecting, tabulating, and publishing federal statistics for a set of 
geographic areas. CBSAs include adjacent counties that have a minimum 
of 25 percent commuting to the central counties of the area. Based on 
the OMB's current delineations, Montgomery County belongs in a separate 
CBSA from the areas defined in the Washington, DC CBSA (CBSA 47764). 
Unlike IPPS hospitals, IRFs, and SNFs, where each provider uses a 
single wage index value, hospice agencies may serve multiple CBSAs and 
be

[[Page 64206]]

reimbursed based on more than one wage index value. Payments are based 
upon the location of the beneficiary for routine and continuous home 
care or the location of the facility for respite and general inpatient 
care. Hospices in Montgomery County, Maryland may provide RHC and CHC 
to patients in the Washington, DC CBSA, as well as to patients in other 
surrounding CBSAs. We have used CBSAs for determining hospice payments 
since FY 2006 and continue to believe that using the most current OMB 
delineations provides an accurate representation of geographic 
variation in wage levels and do not believe it would be appropriate to 
allow hospices to opt for, or be assigned, a CBSA designation with a 
higher wage index value. However, if a future OMB Bulletin updates the 
designation for Montgomery County, Maryland, we would propose this 
change through our normal rulemaking process.
    Comment: A few commenters opposed the use of the IPPS wage index as 
the basis for the hospice wage index. In general, these commenters 
stated that the use of hospital wage data is inappropriate and 
recommended that CMS utilize more appropriate wage information for the 
hospice wage index. These commenters expressed concern that the 
hospital wage index is derived from cost report wage data submitted by 
hospitals which explicitly excludes hospice wage costs. Commenters 
suggested that the exclusion of hospice costs undermines the accuracy 
of wage adjustments for hospice providers and has the potential to lead 
to inadequate services for terminally ill beneficiaries. Additionally, 
two commenters also expressed concern with the lag in the hospital cost 
report data used as the basis for the hospice wage index. One commenter 
stated that the lag in the wage index data used in the proposed rule 
likely means that any increase in reimbursement rates will be quickly, 
and possibly completely, subsumed by recent and anticipated inflation 
rates.
    Response: We appreciate the commenters concerns; however, these 
comments are outside the scope of the proposed rule, as we did not 
propose changes to our hospice wage index methodology. Changes to the 
hospice wage index methodology, including changes to the underlying 
data used to create the hospice wage index, would have to go through 
notice and comment rulemaking. Furthermore, we continue to believe the 
use of the pre-floor and pre-reclassified hospital wage index results 
is the most appropriate adjustment to the labor portion of the hospice 
payment rates. This position is longstanding and consistent with other 
Medicare payment systems; however, we will consider these comments in 
the future if CMS does consider changes to this methodology.
    Comment: A few commenters recommended more far-reaching revisions 
to the hospice wage index methodology. Some commenters, including 
MedPAC, recommended an overhaul of the entire hospice wage index 
methodology. One commenter stated that the time is long overdue for CMS 
to develop and implement a wage index model that is consistent across 
all provider types so that all providers have a level playing field 
from which to compete for personnel. MedPAC recommended that existing 
Medicare wage index policies be repealed, including current exceptions, 
and to phase in a new Medicare wage index system for hospitals and 
other types of providers that uses all-employer, occupation-level wage 
data with different occupation weights for the wage index of each 
provider type; reflects local area level differences in wages between 
and within metropolitan statistical areas and statewide rural areas; 
and smooths wage index differences across adjacent local areas. In 
addition, many commenters recommended allowing hospices to take 
advantage of wage index protections afforded to hospitals such as 
geographic redesignation and the rural floor. One commenter suggested 
that CMS investigate how MedPAC's wage index proposal would impact 
hospices and work with stakeholders, including Congress, to determine 
how to implement a fairer system that also takes into account increased 
labor costs.
    Response: We appreciate the commenters' recommendations; however, 
these comments are outside the scope of the proposed rule, as we did 
not propose changes to our hospice wage index methodology. Any changes 
regarding the adjustment of the hospice payments to account for 
geographic wage differences, beyond the wage index proposals discussed 
in the FY 2025 Hospice Wage Index and Rate Update proposed rule, would 
require notice and comment rulemaking.
    Comment: Several commenters also expressed concern that hospices 
are not given the opportunity for geographic reclassification like 
hospitals. These commenters recommended that hospices be allowed to 
reclassify to a different CBSA to receive a higher wage index in order 
to compete with hospitals and other health systems for the same labor 
pool. One commenter stated that the inability to reclassify a hospice's 
wage index means the hospice wage index often fails to reflect true 
labor costs accurately, placing the hospice at a competitive and 
financial disadvantage. Another commenter recommended that 
reclassification be allowed for provider-based home health and hospice 
providers who are a part of a hospital and/or health system. Many 
commenters also recommended that CMS reinstitute the rural floor policy 
so that no hospice serving patients in urban areas is paid below the 
rural wage index value of the State. These commenters stated that 
hospices are at a competitive disadvantage because they are unable to 
take advantage of geographic reclassification and the rural floor 
provisions that are allowed for hospitals.
    Response: We remind stakeholders that the statutory provisions that 
govern hospice payment do not provide a mechanism for allowing hospices 
to seek geographic reclassification or to utilize the rural floor 
provisions that exist for IPPS hospitals. The reclassification 
provision found in section 1886(d)(10) of the Act is specific to 
hospitals. Section 4410(a) of the Balanced Budget Act of 1997 (Pub. L. 
105-33) provides that the area wage index applicable to any hospital 
that is in an urban area of a State may not be less than the area wage 
index applicable to hospitals located in rural areas in that State. 
This rural floor provision is also specific to hospitals. Because the 
reclassification provision and the hospital rural floor apply only to 
hospitals, and not to hospices (even those hospices that are affiliated 
with a hospital or other health care system), we continue to believe 
the use of the pre-floor and pre-reclassified hospital wage index 
results is the most appropriate adjustment to the labor portion of the 
hospice payment rates. However, we note that hospices do receive the 
hospice floor which adjusts the pre-floor, pre-reclassified hospital 
wage index values below 0.8000 by a 15 percent increase subject to a 
maximum wage index value of 0.8000 and the 5-percent cap on wage index 
decreases.
    Comment: Two commenters encouraged CMS to add details and 
transparency to the wage index section of the rule. These commenters 
requested that CMS describe in detail how the wage index is calculated, 
the basis in the hospital cost report, and the role of the wage index 
standardization factor. Commenters requested this information so that 
hospices receive more information on how and why year to year wage 
index variation occurs.
    Response: We thank the commenters for their recommendations. In 
reference to the commenters' recommendation for more details describing 
how the pre-

[[Page 64207]]

floor pre-reclassified wage index is calculated, we refer readers to 
the FY 2025 IPPS proposed rule (89 FR 36139 through 36159) for 
additional information on the cost report worksheets used to calculate 
the wage index, information on how those worksheets are validated, the 
process for hospitals to request corrections, and the method for 
calculating the proposed unadjusted wage index. Once we receive the 
pre-floor, pre-reclassified wage index values as discussed, those 
values are then adjusted by the hospice floor so that all wage index 
values lower than 0.8000 are increased by 15 percent up to 0.8000. The 
hospice floor adjusted wage index values are subsequently updated by 
the permanent 5-percent cap on wage index decreases so that the wage 
index for the current fiscal year is not less than 95 percent of the 
wage index value the previous fiscal year. Regarding the wage index 
standardization factors, we finalized in the FY 2017 Hospice Wage Index 
and Rate Update final rule (81 FR 52156), a policy of applying wage 
index standardization factors for each level of care to hospice 
payments in order to eliminate the aggregate effect of annual 
variations in hospital wage data. In order to calculate the wage index 
standardization factor, we simulate total payments using FY 2023 
hospice utilization claims data with the FY 2024 wage index (pre-floor, 
pre-reclassified hospital wage index with the hospice floor, old OMB 
delineations, and the 5-percent cap on wage index decreases) and FY 
2024 payment rates and compare that total to our simulation of total 
payments using FY 2023 utilization claims data, the final FY 2025 
hospice wage index (pre-floor, pre-reclassified hospital wage index 
with hospice floor, and the revised OMB delineations, with the 5-
percent cap on wage index decreases) and FY 2024 payment rates. By 
dividing payments for each level of care (RHC days 1 through 60, RHC 
days 61+, CHC, IRC, and GIP) using the FY 2024 wage index and FY 2024 
payment rates for each level of care by the FY 2025 wage index and FY 
2024 payment rates, we obtain a wage index standardization factor for 
each level of care. The wage index standardization factors for each 
level of care are then applied to the national payment amounts for that 
level of care to calculate the final FY 2025 payment amounts.
    Final Decision: We are finalizing our proposal to use the FY 2025 
pre-floor, pre-reclassified hospital wage index data as the basis for 
the FY 2025 hospice wage index. The wage index applicable for FY 2025 
is available on our website at: <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index</a>. The hospice wage 
index for FY 2025 is effective October 1, 2024, through September 30, 
2025.
    There exist some geographic areas where there are no hospitals, and 
thus, no hospital wage data on which to base the calculation of the 
hospice wage index. In the FY 2006 Hospice Wage Index final rule (70 FR 
45135), we adopted the policy that, for urban labor markets without a 
hospital from which hospital wage index data could be derived, all the 
CBSAs within the State would be used to calculate a statewide urban 
average pre-floor, pre-reclassified hospital wage index value to use as 
a reasonable proxy for these areas. For FY 2025, the only CBSA without 
a hospital from which hospital wage data can be derived is 25980, 
Hinesville-Fort Stewart, Georgia. The FY 2025 final wage index value 
for Hinesville-Fort Stewart, Georgia is 0.8872.
    In the FY 2008 Hospice Wage Index final rule (72 FR 50217 through 
50218), we implemented a methodology to update the hospice wage index 
for rural areas without hospital wage data. In cases where there was a 
rural area without rural hospital wage data, we use the average pre-
floor, pre-reclassified hospital wage index data from all contiguous 
CBSAs, to represent a reasonable proxy for the rural area. The term 
``contiguous'' means sharing a border (72 FR 50217). For FY 2025, as 
part of our proposal to adopt the revised OMB delineations discussed 
further in section III.A.2 of this final rule, we proposed that rural 
North Dakota would now become a rural area without a hospital from 
which hospital wage data can be derived. Therefore, to calculate the 
wage index for rural area 99935, North Dakota, we proposed to use as a 
proxy, the average pre-floor, pre-reclassified hospital wage data 
(updated by the hospice floor) from the contiguous CBSAs: CBSA 13900-
Bismark, ND, CBSA 22020-Fargo, ND-MN, CBSA 24220-Grand Forks, ND-MN and 
CBSA 33500, Minot, ND, which resulted in a proposed FY 2025 hospice 
wage index of 0.8446 for rural North Dakota.
    While no commenters expressly opposed or supported this proposal, 
we did receive one comment acknowledging the proposal to shift rural 
North Dakota to a rural area without a hospital from which hospital 
data can be formulated. We are finalizing our proposal to use as a 
proxy the average pre-floor, pre-reclassified hospital wage data 
(updated by the hospice floor) from the contiguous CBSAs: CBSA 13900-
Bismark, ND, CBSA 22020-Fargo, ND-MN, CBSA 24220-Grand Forks, ND-MN and 
CBSA 33500, Minot, ND. For this final rule, using updated data, the 
final FY 2025 hospice wage index for rural North Dakota is 0.8545.
[GRAPHIC] [TIFF OMITTED] TR06AU24.052


[[Page 64208]]


    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 close proximity of almost all of Puerto Rico's various urban areas 
to 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, subsequently adjusted by the hospice floor 
for an adjusted wage index value of 0.4654. For FY 2025, we noted that 
as part of our proposal to adopt the revised OMB delineations discussed 
further in section III.A.2.c of this final rule, there would now be a 
hospital in rural Puerto Rico from which hospital wage data can be 
derived. Therefore, we proposed that the wage index for rural Puerto 
Rico would now be based on the hospital wage data for the area instead 
of the previously available pre-hospice floor wage index of 0.4047, 
which equaled an adjusted wage index value of 0.4654. The FY 2025 
proposed pre-hospice floor unadjusted wage index for rural Puerto Rico 
would be 0.2520, and is subsequently adjusted by the hospice floor to 
equal 0.2898. Because 0.2898 is more than a 5-percent decline in the FY 
2024 wage index, the adjusted FY 2025 wage index with the 5-percent cap 
applied would equal 0.95 multiplied by 0.4654 (that is, the FY 2024 
wage index with floor), which resulted in a proposed wage index of 
0.4421.
    We did not receive any comments on our proposal to use hospital 
wage data to calculate the wage index of rural Puerto Rico instead of 
the previously available hospice floor adjusted wage index of 0.4654. 
We are finalizing this policy as proposed. For FY 2025 the final 
hospice wage index for rural Puerto Rico is 0.2510, subsequently 
adjusted by the hospice floor which equals 0.2887. Because 0.2887 is 
more than a 5-percent decline in the FY 2024 wage index, the adjusted 
FY 2025 wage index with the 5-percent cap applied will equal 0.95 
multiplied by 0.4654 (that is, the FY 2024 wage index with floor), 
which results in a final wage index of 0.4421.
    Finally, due to the proposed adoption of the revised OMB 
delineations discussed in section III.A.2.c of this final rule, we 
noted that 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 FY 2025 wage index for rural area 
99908 Delaware was 1.0429. We did not receive any comments on our 
proposal to use hospital wage data to calculate the wage index of rural 
Delaware. We are finalizing our proposal and the FY 2025 final hospice 
wage index for rural Delaware is 1.0385.
2. Implementation of New Labor Market Delineations
    As discussed, 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, CSAs, 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 (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: 
<a href="https://www.whitehouse.gov/wp-content/uploads/2023/07/OMB-Bulletin-23-01.pdf">https://www.whitehouse.gov/wp-content/uploads/2023/07/OMB-Bulletin-23-01.pdf</a>.
    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 hospice wage index to use the latest OMB delineations available 
in order to maintain the most accurate and up-to-date payment system, 
reflecting 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 hospice wage index by 
creating a more accurate representation of geographic variation in wage 
levels. We proposed to implement the new OMB delineations as described 
in the July 21, 2023, OMB Bulletin No. 23-01 for the hospice wage index 
effective beginning in FY 2025. A summary of comments and our responses 
on this overall proposal, and on the more specific changes discussed in 
sections III.A.2.c through III.A.2.f of this final rule that occur as a 
result of this final policy, are discussed further in this document.
a. Micropolitan Statistical Areas
    As discussed in the FY 2006 Hospice Wage Index and Payment Rate 
Update proposed rule (70 FR 22397) and final rule (70 FR 45132), we 
considered how to use the Micropolitan Statistical Area definitions in 
the calculation of the wage index. Previously, 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 refer 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), 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 Hospice rural wage index (70 FR 22397 and 
70 FR 45132). Thus, the hospice statewide rural wage index has been 
determined using IPPS hospital data from hospitals located in non-MSAs. 
In the FY 2021 Hospice final rule (85 FR 47074, 47080), 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'' continues 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 FY 2025, and consistent with the treatment of Micropolitan 
Areas under

[[Page 64209]]

the IPPS, we also proposed to continue to treat Micropolitan Areas as 
``rural'' and to include Micropolitan Areas in the calculation of each 
State's rural wage index.
    Final Decision: We did not receive any comments on our proposal to 
continue to treat Micropolitan Areas as rural and to include those 
areas in the calculation of each State's rural wage index. We are 
finalizing this policy as proposed.
b. Change to County-Equivalents in the State of Connecticut
    In a June 6, 2022, 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 evaluated 
the change and proposed to adopt the planning regions as county 
equivalents for wage index purposes. We believe it is necessary to 
adopt this migration from counties to planning region county-
equivalents in order to maintain consistency with our established 
policy of adopting the most recent OMB updates.
    Final Decision: We did not receive any comments on our proposal to 
adopt the Connecticut planning regions as county equivalents for wage 
index purposes. We are finalizing this policy as proposed. We are 
providing the following crosswalk in Table 2 for counties located in 
Connecticut with the current and final FIPS county and county-
equivalent codes and CBSA assignments.
[GRAPHIC] [TIFF OMITTED] TR06AU24.053

c. Urban Counties That Would Become Rural
    Under the revised OMB statistical area delineations (based upon OMB 
Bulletin No. 23-01), a total of 53 counties (and county equivalents) 
that are currently considered urban would be considered rural beginning 
in FY 2025. Table 3 lists the 53 counties that will become rural when 
we implement the revised OMB delineations.

[[Page 64210]]

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[[Page 64211]]


[GRAPHIC] [TIFF OMITTED] TR06AU24.055

d. Rural Counties That Would Become Urban
    Under the revised OMB statistical area delineations (based upon OMB 
Bulletin No. 23-01), a total of 54 counties (and county equivalents) 
that are currently located in rural areas will be considered located in 
urban areas under the revised OMB delineations beginning in FY 2025. 
Table 4 lists the 54 counties that will be urban if we implement the 
revised OMB delineations beginning in FY 2025.

[[Page 64212]]

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[[Page 64213]]


[GRAPHIC] [TIFF OMITTED] TR06AU24.057

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 5 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 sections).

[[Page 64214]]

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[[Page 64215]]


[GRAPHIC] [TIFF OMITTED] TR06AU24.059

    In some cases, all the urban counties from a FY 2024 CBSA would be 
moved and subsumed by another CBSA in FY 2025. Table 6 lists the CBSAs 
that, under our proposal to adopt the revised OMB statistical area 
delineations, would be subsumed by another CBSA.
[GRAPHIC] [TIFF OMITTED] TR06AU24.060

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

[[Page 64216]]

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 7 lists the 73 urban counties that would move 
from one urban CBSA to a new or modified urban CBSA if we adopt the 
revised OMB delineations.
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[[Page 64217]]


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[[Page 64218]]


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[[Page 64219]]


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[[Page 64220]]


[GRAPHIC] [TIFF OMITTED] TR06AU24.065

f. Transition Period
    In the past we have provided for transition periods when adopting 
changes that have significant payment implications, particularly large 
negative impacts, in order to mitigate the potential impacts of 
proposed policies on hospices. For example, we have proposed and 
finalized budget-neutral transition policies to help mitigate negative 
impacts on hospices following the adoption of the new CBSA delineations 
based on the 2010 Decennial Census data in the FY 2016 hospice final 
rule (80 FR 47142). Specifically, we applied a blended wage index for 
one year (FY 2016) for all geographic areas that consisted 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 FY 2016 wage index using the old labor market area delineation and 
50 percent of the FY 2016 wage index using the new labor market area 
delineations, which resulted in an average of the two values. 
Additionally, in the FY 2021 hospice final rule (85 FR 47079 through 
47080), 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 FY. 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 FY 2021 (that is, no cap was applied to the reduction in the wage 
index for the second year (FY 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 FY 2021, as it provided predictability 
in payment levels from FY 2020 to FY 2021 and additional transparency 
because it was administratively simpler than our prior one-year 50/50 
blended wage index approach.
    As discussed previously, in the FY 2023 hospice final rule, we 
adopted a permanent 5-percent cap on wage index decreases beginning in 
FY 2023 and each subsequent year (87 FR 45677). 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 FY.
    For FY 2025, we believe that the permanent 5-percent cap on wage 
index decreases would be sufficient to mitigate any potential negative 
impact for hospices serving beneficiaries in areas that are impacted by 
the proposal to adopt 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 FY 2025, to mitigate any

[[Page 64221]]

potential negative impact caused by our proposed adoption of the 
revised delineations, we proposed that in addition to the 5-percent cap 
being calculated for an entire CBSA or statewide rural area 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 fiscal year. 
Specifically, we proposed for FY 2025, that the 5-percent cap would 
also be applied to counties that move from a CBSA or statewide rural 
area with a higher wage index value into a new CBSA or rural area with 
a lower wage index value, so that the county's FY 2025 wage index would 
not be less than 95 percent of the county's FY 2024 wage index value 
under the old delineation despite moving into a new delineation with a 
lower wage index.
    Due to the way that we proposed to calculate the 5-percent cap for 
counties that experience an OMB designation change, some CBSAs and 
statewide rural areas could have more than one wage index value because 
of the potential for their constituent counties to have different wage 
index values as a result of application of the 5-percent cap. 
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 hospice claims processing, each CBSA or 
statewide rural area can have only one wage index value assigned to 
that CBSA or statewide rural area.
    Therefore, hospices 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 for hospice claims in FY 2025. We proposed that beginning 
in FY 2025, counties that have a different wage index value than the 
CBSA or rural area into which they are designated due to the 
application of the 5-percent cap would use a wage index transition 
code. These special codes are five digits in length and begin with 
``50.'' The 50XXX 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 FY 2025 we proposed that Lamar County would be redesignated into 
the Rural Georgia Code 99911. Because the wage index value of rural 
Georgia is more than a 5-percent decrease from the wage index value 
that Lamar County previously received under CBSA 12060, the FY 2025 
wage index for Lamar County would be capped at 95 percent of the FY 
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 FY 2025, 
transition code 50002 would be used instead of rural Georgia code 
99911.
    Table 8 includes a list of counties that have changed designation 
and must use a transition code beginning in FY 2025. This list is 
comprised of counties that are redesignated into a new CBSA or rural 
area and will receive the 5-percent cap on wage index decreases. These 
counties must use a transition code because the wage index for that 
county is higher than all other constituent counties that make up the 
CBSA or rural area (like the example above for Lamar County, GA.) 
Additionally, the list also includes counties that move into a new CBSA 
or rural area and have a different wage index value because the 
constituent counties that make up the CBSA or rural receive the 5-
percent cap for FY 2025 while the county that moves into the CBSA or 
rural area does not. For example, rural area 99922 rural Massachusetts 
is comprised of FIPS code 25007 Dukes County, FIPS code 25019 Nantucket 
County and the redesignated FIPS code 25011 Franklin County. Dukes 
County and Nantucket County were part of rural area 99922 Massachusetts 
for FY 2024 and will receive the 5-percent cap because the FY 2025 wage 
index for rural area 99922 is more than a 5-percent decrease from the 
FY 2024 wage index for rural area 99922. However, Franklin County was 
included in CBSA 44140 Springfield, MA in FY 2024 and the uncapped FY 
2025 wage index for rural area 99922 is higher than the FY 2024 wage 
index for CBSA 44140. In this example, Franklin County, MA would 
receive the uncapped wage index for rural Area 99922 while Dukes and 
Nantucket counties receive the 5-percent capped wage index. Therefore, 
hospices that serve beneficiaries in Franklin County, MA must use the 
transition code 50010 on hospice claims.
    Additionally, we proposed that the 5-percent cap would apply to a 
county that corresponds to a different wage index value than the wage 
index value in the CBSA or rural area in which they are designated due 
to a delineation change until the county's new wage index is more than 
95 percent of the wage index from the previous fiscal year. We also 
proposed that in order to capture the correct wage index value, the 
county would continue to use the assigned 50XXX transition code until 
the county's wage index value calculated for that fiscal year using the 
new OMB delineations is not less than 95 percent of the county's capped 
wage index from the previous fiscal year. Thus, in the example 
mentioned previously, Lamar County would continue to use transition 
code 50002 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 fiscal year. The counties that will require a 
transition code in FY 2025 and the corresponding 50XXX codes are shown 
in Table 8 and will also be shown in the last column of the FY 2025 
hospice wage index file.

[[Page 64222]]

[GRAPHIC] [TIFF OMITTED] TR06AU24.066

    We received 11 comments on our proposal to adopt the latest OMB 
delineations from OMB Bulletin No. 23-01 (and the resulting changes) 
with the permanent 5-percent cap as a transition. The following is a 
summary of these

[[Page 64223]]

comments and our responses to those comments.
    Comment: Most commenters stated that they support the adoption of 
the revised OMB delineations from the July 21, 2023, Bulletin No. 23-
01. Most commenters also expressed support for the use of the permanent 
5-percent cap policy as a transition to the policy.
    Response: We appreciate the commenters' support of the adoption of 
the new OMB delineations and the use of the permanent 5-percent cap as 
a transition.
    Comment: A few commenters opposed our proposal to adopt the new 
delineations. One commenter from Montgomery County, MD, expressed 
concern that the revised delineations fail to resolve the issue of the 
county being excluded from the Washington, DC CBSA. Other commenters 
stated that the adoption of the revised OMB delineations would result 
in a reduction in reimbursement for counties in states such as 
California, Illinois, and New York. One commenter suggested that the 
proposed updates to CBSAs based on the 2020 Decennial Census will not 
only eliminate any proposed rate increase but will reduce reimbursement 
in thirty-three percent of New York's sixty-one counties.
    Response: We appreciate the concerns commenters raised regarding 
the impact of implementing the revised designations on their specific 
counties. While we understand the concern regarding the potential 
financial impact, we believe that implementing the revised OMB 
delineations will create more accurate representations of labor market 
areas nationally and result in hospice wage index values being more 
representative of the actual costs of labor in a given area. Although 
these comments only addressed any negative impacts on specific 
geographic areas, we believe it is important to note that there are 
many geographic locations and hospice providers that will experience 
positive impacts upon implementation of the revised CBSA designations. 
We believe that the OMB delineations for Metropolitan and Micropolitan 
Statistical Areas are appropriate for use in accounting for wage area 
differences and that the values computed under the revised delineations 
will result in more appropriate payments to providers by more 
accurately accounting for and reflecting the differences in area wage 
levels. We also recognize that there are areas which will experience a 
decrease in their wage index. As such, it is our longstanding policy to 
provide temporary adjustments to mitigate negative impacts from the 
adoption of new policies or procedures. In the FY 2025 Hospice Wage 
Index and Payment Rate Update proposed rule, we proposed to use the 
finalized 5-percent cap policy as a transition in order to mitigate the 
resulting short-term instability and negative impacts on certain 
providers. We continue to believe that the finalized 5-percent cap 
policy provides an adequate safeguard against any significant payment 
reductions, allows for sufficient time to make operational changes for 
future fiscal years, and provides a reasonable balance between 
mitigating some short-term instability in hospice payments and 
improving the accuracy of the payment adjustment for differences in 
area wage levels.
    Comment: A few commenters, including MedPAC, suggested alternatives 
to the 5-percent cap transition policy. MedPAC suggested that the 5-
percent cap limit should apply to both increases and decreases in the 
wage index so that no provider would have its wage index value increase 
or decrease by more than 5 percent. However, several commenters 
recommended lowering the finalized 5-percent cap on wage index 
decreases (for example, a 2-percent cap was recommended). These 
commenters stated that capping decreases at 5 percent is insufficient 
to mitigate negative impacts faced by hospices. One commenter stated 
that while the permanent maximum drop in wage index values is 
appreciated, even a 5 percent drop in rates from one year to the next 
in this inflationary time is very difficult. Another commenter 
recommended that CMS limit the maximum wage index reduction to a 
percentage equal to or less than the payment update for that year. This 
commenter also suggested that CMS change the policy so that there is no 
reduction in wage index values but instead only increases. One 
commenter recommended the wage index cap be lowered for FY 2025 as a 
transition to the adoption of the revised delineations. Two commenters 
requested that CMS institute a one-time zero wage index adjustment in 
all CBSAs where there is a negative adjustment.
    Response: We appreciate the commenters' recommendations for changes 
to the finalized cap policy. Regarding MedPAC's suggestion that the cap 
on wage index changes of more than 5 percent should also be applied to 
wage index increases, as we discussed previously, the purpose of the 
finalized 5-percent cap policy is to help mitigate the significant 
negative impacts of certain wage index changes. Additionally, we 
believe that the 5-percent cap on wage index decreases is an adequate 
safeguard against any significant payment reductions and do not believe 
that capping wage index decreases at 2 percent instead of 5 percent is 
appropriate. We also do not believe it would be appropriate to 
institute a one-time zero wage index adjustment or implement a policy 
where there are no wage index decreases. We continue to believe that a 
5-percent cap would more effectively mitigate any significant decreases 
in a hospice's wage index for a fiscal year, while still balancing the 
importance of ensuring that area wage index values accurately reflect 
relative differences in area wage levels. Furthermore, a 5-percent cap 
on wage index decreases provides a degree of predictability in payment 
changes for providers and allows providers time to adjust to any 
significant decreases they may face year to year.
    Final Decision: We are finalizing our proposal to adopt the revised 
OMB delineations from the July 21, 2018 OMB Bulletin 23-01, and will 
also apply the permanent 5-percent cap on wage index decreases at the 
county level with the use of a transition code, so that counties 
impacted by the revised designations will receive a 5-percent cap on 
any decrease in a geographic area's wage index value from the wage 
index value from the prior fiscal year for FY 2025. We are also 
finalizing that beginning in FY 2025, counties that have a different 
wage index value than the CBSA or rural area into which they are 
designated due to the application of the 5-percent cap (including 
redesignated counties that will receive the 5-percent cap and 
redesignated counties that move into a CBSA or rural area where all 
other constituent counties receive the 5-percent cap) would use a wage 
index transition code. These special codes are five digits in length 
and begin with ``50.'' The 50XXX wage index transition codes will be 
used only in specific counties; counties located in CBSAs and rural 
areas that do not correspond to a different transition wage index value 
will still use the CBSA number. Finally, we are finalizing the policy 
that the 5-percent cap will apply to a county that corresponds to a 
different wage index value than the wage index value in the CBSA or 
rural area in which they are designated due to a delineation change 
until the county's new wage index is more than 95 percent of the wage 
index from the previous fiscal year. In order to capture the correct 
wage index value, the county will continue to use the assigned 50XXX 
transition code until the county's wage index value calculated for that 
fiscal year using the new OMB delineations is

[[Page 64224]]

not less than 95 percent of the county's capped wage index from the 
previous fiscal year.
    The final FY 2025 wage index file provides a crosswalk between the 
current OMB delineations and the final revised OMB delineations that 
will be in effect in FY 2025. This file shows each State and county and 
its corresponding final wage index along with the previous CBSA number, 
the final CBSA number or alternate identification number, and the final 
CBSA name. The final hospice wage index file applicable for FY 2025 
(October 1, 2024 through September 30, 2025) is available on the CMS 
website at: <a href="https://www.cms.gov/medicare/payment/fee-for-service-providers/hospice/hospice-wage-index">https://www.cms.gov/medicare/payment/fee-for-service-providers/hospice/hospice-wage-index</a>.
3. FY 2025 Hospice Payment Update Percentage
    Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 
105-33) amended section 1814(i)(1)(C)(ii)(VI) of the Act to establish 
updates to hospice rates for FYs 1998 through 2002. Hospice rates were 
to be updated by a factor equal to the inpatient hospital market basket 
percentage increase set out under section 1886(b)(3)(B)(iii) of the 
Act, minus one percentage point. Payment rates for FYs since 2002 have 
been updated as required by section 1814(i)(1)(C)(ii)(VII) of the Act, 
which states that the update to the payment rates for subsequent FYs 
must be the inpatient hospital market basket percentage increase for 
that FY. In the FY 2022 IPPS final rule, we finalized the rebased and 
revised IPPS market basket to reflect a 2018 base year. We refer 
readers to the FY 2022 IPPS final rule (86 FR 45194) for further 
information.
    Section 3401(g) of the Affordable Care Act mandated that, starting 
with FY 2013 (and in subsequent FYs), the hospice payment update 
percentage would be annually reduced by changes in economy-wide 
productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. 
The statute defines the productivity adjustment to be equal to the 10-
year moving average of changes in annual economy-wide private nonfarm 
business multifactor productivity (MFP) as projected by the Secretary 
for the 10-year period ending with the applicable FY, year, cost 
reporting period, or other annual period (the ``productivity 
adjustment''). The United States Department of Labor's 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 would 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.'' However, as mentioned, 
the data and methods are unchanged. We refer readers to <a href="http://www.bls.gov">http://www.bls.gov</a> for the BLS historical published TFP data. A complete 
description of IGI's TFP projection methodology is available on the CMS 
website at <a href="https://www.cms.gov/data-research/statistics-trends-and-reports/medicare-program-rates-statistics/market-basket-research-and-information">https://www.cms.gov/data-research/statistics-trends-and-reports/medicare-program-rates-statistics/market-basket-research-and-information</a>. In addition, in the FY 2022 IPPS final rule (86 FR 45214), 
we noted that beginning with FY 2022, CMS changed the name of this 
adjustment to refer to it as the ``productivity adjustment'' rather 
than the ``MFP adjustment''. Consistent with our historical practice, 
we estimate the market basket percentage increase and the productivity 
adjustment based on IHS Global Inc.'s (IGI's) forecast using the most 
recent available data. The proposed hospice payment update percentage 
for FY 2025 was based on the most recent estimate of the inpatient 
hospital market basket (based on IGI's fourth quarter 2023 forecast 
with historical data through the third quarter of 2023). Due to the 
requirements at sections 1886(b)(3)(B)(xi)(II) and 1814(i)(1)(C)(v) of 
the Act, the proposed inpatient hospital market basket percentage 
increase for FY 2025 of 3.0 percent is required to be reduced by a 
productivity adjustment as mandated by section 3401(g) of the 
Affordable Care Act. The proposed productivity adjustment for FY 2025 
was 0.4 percentage point (based on IGI's fourth quarter 2023 forecast). 
Therefore, the proposed hospice payment update percentage for FY 2025 
was 2.6 percent. We also proposed that if more recent data became 
available after the publication of the proposed rule and before the 
publication of the final rule (for example, a more recent estimate of 
the inpatient hospital market basket percentage increase or 
productivity adjustment), we would use such data, if appropriate, to 
determine the hospice payment update percentage in the FY 2025 final 
rule. We continue to believe it is appropriate to routinely update the 
hospice payment system so that it reflects the best available data 
about differences in patient resource use and costs among hospices as 
required by the statute.
    In the FY 2022 Hospice Wage Index final rule (86 FR 42532), we 
rebased and revised the labor shares for RHC, CHC, GIP, and IRC using 
Medicare cost report data for freestanding hospices (CMS Form 1984-14, 
OMB Control Number 0938-0758) from 2018. The current labor portion of 
the payment rates are: RHC, 66.0 percent; CHC, 75.2 percent; GIP, 63.5 
percent; and IRC, 61.0 percent. The non-labor portion is equal to 100 
percent minus the labor portion for each level of care. The non-labor 
portion of the payment rates are as follows: RHC, 34.0 percent; CHC, 
24.8 percent; GIP, 36.5 percent; and IRC, 39.0 percent. We received 45 
comments on the proposed hospice update percentage of 2.6 percent. A 
summary of the comments and our responses to those comments are as 
follows:
    Comment: A couple of commenters stated appreciation for the 
proposed hospice market basket update for FY 2025; however, most 
commenters stated that the proposed 2.6 percent increase does not cover 
the increased operating costs they have faced throughout the pandemic. 
The commenters requested CMS determine whether additional updates could 
be made during FY 2025.
    Specifically, the commenters stated that they have been facing 
unprecedented increases in labor costs, particularly for nursing staff 
and that labor accounts for a large percentage of their operating 
costs, more so than other provider types. Additionally, several 
commenters noted that the healthcare worker shortages exacerbate wage 
pressure increases. For example, a few commenters stated that their 
compensation costs account for approximately 80 percent of the overall 
operating costs. Several commenters stated that they have experienced 
increased expenses for employed nursing staff, therapy staff, and 
ancillary staff. Many commenters noted the difficulty in recruiting and 
retaining staff, as other provider types can pay higher wages. One 
commenter stated that New York State Medicaid recognized the 
catastrophic impact of rising healthcare costs and approved a rate 
increase of 3.5 percent, acknowledging the higher cost of doing 
business in New York, which was partly driven by the largest wage 
increase in New York City's public sector nursing history. One industry 
association stated that their members reported that

[[Page 64225]]

workforce shortages are their biggest challenge.
    The commenters also stated that the proposed payment update does 
not appropriately capture the inflation pressures experienced for non-
labor operating expenses, specifically the increased costs for medical 
supplies, pharmaceuticals, materials, and utilities. One commenter 
stated that their total drug expenses per hospice day are 14 percent 
higher and medical supply costs and staff travel reimbursement (as 
staff travel to patient homes to provide care) have increased 4 percent 
and 6.5 percent, respectively, over the past year. The commenters 
stated that it has been difficult to budget wage increases in order to 
attract and retain staff while at the same time covering higher input 
costs for other operating expenses.
    Several commenters explicitly noted that the proposed 2.6 percent 
increase in hospice payments is less than the current rate of U.S. 
inflation as measured by the Consumer Price Index for All Urban 
Consumers (CPI-U) which they state increased by 3.4 percent year-over-
year in April 2024, nearly a percent higher than the proposed FY 2025 
hospice update of 2.6 percent. One commenter also noted that the 
proposed update is below the 3.7 percent increase for Medicare 
Advantage plans. Several commenters stated that unlike other Medicare 
provider types, like hospitals, most hospice care is financed 
predominantly by Medicare and Medicaid and as a result, hospice 
providers are unable to shift costs to other payers to help offset 
losses.
    MedPAC recognized that CMS is required by statute to propose an 
increase to the hospice payment rates; however, the Commission 
recommended eliminating the update for FY 2025. The Commission 
referenced their March 2024 Report to the Congress and that their 
assessment of indicators of payment adequacy for hospices--beneficiary 
access to care, quality of care, provider access to capital, and 
Medicare payments relative to providers' costs--were positive. 
Additionally, MedPAC noted that hospice Medicare profit margins were 
between 13 to 17 percent in aggregate.
    Response: We appreciate the commenters' support for the statutorily 
required hospice payment update and reiterate that we are required to 
update hospice payments by the IPPS market basket update adjusted for 
productivity, as directed by section 1814(i)(1)(C)(ii)(VII) of the Act. 
We believe the increase in the 2018-based IPPS operating market basket 
adequately reflects the average change in the price of goods and 
services hospitals purchase in order to provide medical services. The 
IPPS market basket is a fixed-weight, Laspeyres-type index that 
measures price changes over time and would not reflect increases in 
costs associated with changes in the volume or intensity of input goods 
and services. As such, the IPPS market basket update would reflect the 
prospective price pressures described by the commenters during a high 
inflation period (such as faster wage growth or higher energy prices) 
but might not reflect other factors that could increase costs such as 
the quantity of labor used or any shifts between contract and staff 
nurses. We note that cost changes (that is, the product of price and 
quantities) would only be reflected when a market basket is rebased, 
and the base year weights are updated to a more recent time period.
    We agree with the commenters that recent higher inflationary trends 
have impacted the outlook for price growth over the pandemic period. 
However, the purpose of the FY 2025 hospice payment update is to 
reflect the price pressures providers are expected to face in FY 2025, 
and thus is a forward-looking update as opposed to one that reflects 
historical price changes. At the time of the FY 2025 hospice PPS 
proposed rule, based on IGI's fourth quarter 2023 forecast with 
historical data through third quarter 2023, IGI forecasted the 2018-
based IPPS market basket update of 3.0 percent for FY 2025 reflecting a 
3.6-percent forecasted compensation price increase. We would note that 
the 10-year historical average (2014-2023) growth rate of the 2018-
based IPPS market basket is 2.8 percent with compensation prices 
increasing 2.8 percent. We stated in the FY 2025 hospice PPS proposed 
rule (89 FR 23800) that if more recent data became available, we would 
use such data, if appropriate, to derive the final FY 2025 hospice 
payment update percentage for the final rule. For this final rule, we 
are using an updated forecast of the price proxies underlying the 2018-
based IPPS market basket that incorporates more recent historical data 
and reflects a revised outlook regarding the U.S. economy, including 
compensation and inflationary pressures. Based on IGI's second quarter 
2024 forecast with historical data through first quarter 2024, the FY 
2025 IPPS market basket update is 3.4 percent (reflecting forecasted 
compensation price growth of 3.9 percent). The FY 2025 productivity 
adjustment based on IGI's second quarter 2024 forecast is 0.5 
percentage point. Therefore, as discussed further in this section and 
after consideration of the comments received, for FY 2025, the final 
hospice payment update is 2.9 percent (3.4 percent market basket 
percentage increase less a 0.5 percentage point productivity 
adjustment), compared to the proposed hospice payment update of 2.6 
percent. Finally, we believe the FY 2025 hospice payment update to be 
adequate based on the MedPAC analysis that showed positive payment 
indicators of beneficiary access to care, quality of care, provider 
access to capital, and Medicare payments relative to providers' costs.
    Comment: Many commenters stated that there have been 3 years of 
under forecasted payment rate updates. The commenters noted that the 
market basket forecast for FY 2021 through FY 2023 was cumulatively 
under forecast by 4.6 percentage points over those 3 years and 
requested a one-time retrospective adjustment to rectify the 
significant forecast error since 2021. The commenters stated that they 
understand that the market basket updates are based on a forecast of 
projected inflation; however, they also stated that multiple years in a 
row of significantly under forecast updates is not sustainable and has 
impaired hospices' capacity to serve their beneficiary communities. 
Several commenters also acknowledged that while the adjustment can be 
applied positively or negatively, the update for the last 3 years was 
consistently and significantly under forecast. A few commenters pointed 
to the public data from the CMS Office of the Actuary, which show the 
actual forecast error. Finally, commenters noted that the inadequacy of 
this payment update is further compounded by continued sequestration, 
which reduces Medicare payments by two percent and is currently set to 
continue through FY 2032. Many commenters requested a retrospective 
adjustment be finalized to account for the significant forecast error 
since 2021.
    Several commenters highlighted that the CMS response to a similar 
concern in the FY 2024 rule stated that CMS lacks the statutory 
authority to implement an adjustment; however, the commenters requested 
that CMS provide additional information and a specific explanation 
supporting that it lacks the statutory authority to apply an adjustment 
using the special exceptions and adjustment authority. Several 
commenters also stated that there exists a precedent for CMS to adjust 
for forecast errors in the market basket updates, as was previously 
implemented in a SNF PPS update, which finalized a 3.6 percent forecast 
error adjustment in the FY 2024 SNF

[[Page 64226]]

PPS final rule (88 FR 53205 through 53206). One commenter stated the 
cumulative forecast error of hospital market basket updates was below 
both the growth in the Employment Cost Index (ECI) total compensation 
index and the Producer Price Index (PPI)--All Commodities Index. One 
commenter requested that CMS impose an additional 3 percent payment 
adjustment at a minimum even if the full cumulative forecast error 
adjustment is not possible.
    Several commenters stated that if CMS is limited by statute to 
implement a forecast error adjustment for updating hospice payments 
that CMS work with Congress to include funding for a one-time market 
basket forecast error adjustment for hospice providers as a component 
of any end of year legislation taken up by the 118th Congress.
    Response: We thank the commenters for their recommendations. The 
inpatient hospital market basket percentage increases are required by 
law to be set prospectively, which means that the update relies on a 
mix of both historical data for part of the period for which the update 
is calculated and forecasted data for the remainder. There is currently 
no mechanism to adjust for market basket forecast error in the hospice 
payment update. Furthermore, beginning in 1989, the Congress gave 
hospices their first increase (20 percent) in payment since 1986 and 
tied future increases to the annual increase in the hospital market 
basket through a provision contained in the Omnibus Budget 
Reconciliation Act of 1989. While the projected inpatient hospital 
market basket percentage increases for FY 2021, FY 2022, and FY 2023 
were under forecast, this was largely due to unanticipated inflationary 
and labor market pressures as the economy emerged from the COVID-19 
PHE. Importantly, the hospital market basket has been used for many 
years to update hospice payment rates and an analysis of the forecast 
error over a longer period of time shows that the forecast error has 
been both positive and negative. For example, the 10-year cumulative 
forecast error (excluding FY 2018 when the hospice payment update was 
statutorily required to be 1.0 percent) was slightly positive, equal to 
0.2 percentage point (2014-2023). Each year from 2014 through 2020, the 
final FY hospital market basket update was higher than the actual 
hospital market basket update once historical data was finalized; with 
(5 out of the 7 years between 2014 to 2020 having a forecast error 
greater than 0.5 percentage point.). Only considering the forecast 
error for years when the final inpatient hospital market basket 
percentage increase was lower than the actual inpatient hospital market 
basket percentage increase does not consider the numerous years that 
providers benefited from the forecast error. CMS understands that the 
market basket updates may differ from other overall inflation indexes 
such as the topline ECI, CPI, or PPI; however, we would reiterate that 
comparisons between these topline indexes are not comparable since they 
measure different mixes of products, services, or wages than reflected 
in the legislatively defined CMS IPPS hospital market basket.
    Comment: One commenter stated they have repeatedly shared concerns 
with CMS on the quality of cost report data, especially with regards to 
capturing actual labor costs, and that cost reports should be improved 
and optimized before they are used for payment purposes. The commenter 
recommends that the cost reports be amended to allow for a greater 
breakdown of costs for contracted versus hospice-administered inpatient 
services to apportion the labor share appropriately. They further 
requested that CMS clarify how frequently they intend to update the 
labor share component moving forward and clarify the development and 
methodology around the ``standardization factor.'' This includes 
clarification as to how CMS will adjust the labor share if certain 
types of hospices are found to provide more services and thus, are 
likely to have a larger labor share but contribute fewer cost reports. 
Lastly the commenter recommended that the definition of a ``day'' be 
any 24-hour period or that CMS create a modifier to allow hospices to 
bill into a second day up to a 24-hour limit.
    Response: We appreciate the commenter's request for future changes 
to the hospice cost report. The labor shares for other PPS systems (for 
example, IPPS and HHA) are typically updated every 4 to 5 years. As 
stated in the FY 2022 hospice final rule (86 FR 42533 through 42534), 
we tentatively plan to rebase the hospice labor shares on a similar 
schedule as the other payment systems under Medicare. However, in light 
of the COVID-19 Public Health Emergency (PHE), we plan to monitor the 
upcoming Medicare cost report data to see if more frequent revision of 
the hospice labor shares is necessary in order to reflect more recent 
cost structures of hospice providers. Given that the COVID-19 PHE 
continued into 2023, we have only been able to conduct preliminary 
analysis of 2021 and 2022 Medicare cost report data as the 2023 
Medicare cost report data are not yet available. Therefore, in the FY 
2025 hospice proposed rule, we did not propose to rebase the hospice 
labor shares because of this incomplete data. We will continue to 
monitor these data and any future revisions to the hospice labor shares 
will be proposed and subject to public comments in future rulemaking.
    Comment: One commenter stated that the updated hospice wage index 
should reflect the competitive nature of the healthcare job market and 
include substantial increases in hourly rates for hospice registered 
nurses, certified nursing assistants, and support staff. They further 
stated that the Bureau of Labor Statistics reports that a hospice nurse 
earns an average of $32.10 per hour while the average for nurses in all 
other settings is $39.05 per hour. They noted that vacancy rates for 
registered nurses and licensed practical nurses is averaging as high as 
20 percent in some states. They stated that this issue can be solved by 
increasing the payment rate of hospice workers through the update of 
this rule.
    Response: We appreciate the commenter's concerns regarding labor 
wage rates. Hospice payment rates for FYs since 2002 have been updated 
according to section 1814(i)(1)(C)(ii)(VII) of the Act, which provides 
that the update to the payment rates for subsequent FYs must be the 
inpatient hospital market basket percentage increase for that FY. 
Additionally, as mandated by section 3401(g) of the Affordable Care 
Act, the inpatient hospital market basket percentage increase is 
required to be reduced by a productivity adjustment. The inpatient 
hospital market basket percentage increase reflects the projected wage 
inflation for healthcare and non-health care workers employed in 
hospitals (as measured by the Employment Cost Index (ECI) for wages and 
salaries for hospital workers). As stated in the FY 2025 hospice 
proposed rule (89 FR 23800), we estimated the market basket percentage 
increase and the productivity adjustment based on IHS Global Inc.'s 
(IGI's) forecast using the most recent available data. IGI is a 
nationally recognized economic and financial forecasting firm with 
which CMS contracts to forecast the price proxies of the market 
baskets. The proposed inpatient hospital market basket percentage 
increase for FY 2025 was 3.0 percent reflecting compensation prices 
increasing 3.6 percent. When developing its forecasts for the ECI for 
wages and salaries and employee benefits for hospital workers, IHS 
Global Inc. considers the overall competitive

[[Page 64227]]

nature of labor market conditions. We would note that the 10-year 
historical average (2014-2023) growth rate of the 2018-based IPPS 
market basket is 2.8 percent with compensation prices increasing 2.8 
percent. As also stated in the FY 2025 hospice proposed rule (89 FR 
23800), we stated that if more recent data became available after the 
publication of the proposed rule and before the publication of the 
final rule (for example, a more recent estimate of the inpatient 
hospital market basket percentage increase or productivity adjustment), 
we would use such data, if appropriate, to determine the hospice 
payment update percentage in the FY 2025 final rule.
    Final Decision: We are finalizing the hospice payment update using 
the methodology outlined. For this final rule, based on the more recent 
IGI second quarter 2024 forecast with historical data through the first 
quarter of 2024 the 2018-based IPPS market basket increase factor for 
FY 2025 is 3.4 percent. The FY 2025 productivity adjustment based on 
the more recent IGI second quarter 2024 forecast is 0.5 percentage 
point. Therefore, CMS is finalizing for FY 2025, a hospice payment 
update of 2.9 percent (3.4 percent market basket percentage increase 
less a 0.5 percentage point productivity adjustment).
4. FY 2025 Hospice Payment Rates
    There are four payment categories that are distinguished by the 
location and intensity of the hospice services provided. The base 
payments are adjusted for geographic differences in wages by 
multiplying the labor share, which varies by category, of each base 
rate by the applicable hospice wage index. A hospice is paid the RHC 
rate for each day the beneficiary is enrolled in hospice, unless the 
hospice provides CHC, IRC, or GIP. CHC is provided during a period of 
patient crisis to maintain the patient at home; IRC is short-term care 
to allow the usual caregiver to rest and be relieved from caregiving; 
and GIP care is intended to treat symptoms that cannot be managed in 
another setting.
    As discussed in the FY 2016 Hospice Wage Index and Rate Update 
final rule (80 FR 47172), we implemented two different RHC payment 
rates, one RHC rate for the first 60 days and a second RHC rate for 
days 61 and beyond. In addition, in that final rule, we implemented a 
Service Intensity Add-On (SIA) payment for RHC when direct patient care 
is provided by a registered nurse (RN) or social worker during the last 
seven days of the beneficiary's life. The SIA payment is equal to the 
CHC hourly rate multiplied by the hours of nursing or social work 
provided (up to four hours total) that occurred on the day of service 
if certain criteria are met. To maintain budget neutrality, as required 
under section 1814(i)(6)(D)(ii) of the Act, the new RHC rates were 
adjusted by an SIA budget neutrality factor (SBNF). The SBNF is used to 
reduce the overall RHC rate in order to ensure that SIA payments are 
budget neutral. At the beginning of every FY, SIA utilization is 
compared to the prior year in order calculate a budget neutrality 
adjustment. For FY 2025, the proposed SIA budget neutrality factor is 
1.009 for RHC days 1-60 and 1.000 for RHC days 61+.
    In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 
52156), we initiated a policy of applying a wage index standardization 
factor to hospice payments in order to eliminate the aggregate effect 
of annual variations in hospital wage data. For FY 2025 hospice rate 
setting, we are continuing our longstanding policy of using the most 
recent data available. Specifically, we proposed to use FY 2023 claims 
data as of January 11, 2024 for the FY 2025 payment rate updates. We 
noted that the budget neutrality factors and payment rates would be 
updated with more complete FY 2023 claims data for the final rule. In 
order to calculate the wage index standardization factor, we simulate 
total payments using FY 2023 hospice utilization claims data with the 
FY 2024 wage index (pre-floor, pre-reclassified hospital wage index 
with the hospice floor, old OMB delineations, and the 5-percent cap on 
wage index decreases) and FY 2024 payment rates and compare it to our 
simulation of total payments using FY 2023 utilization claims data, the 
final FY 2025 hospice wage index (pre-floor, pre-reclassified hospital 
wage index with hospice floor, and the revised OMB delineations, with 
the 5-percent cap on wage index decreases) and FY 2024 payment rates. 
By dividing payments for each level of care (RHC days 1 through 60, RHC 
days 61+, CHC, IRC, and GIP) using the FY 2024 wage index and FY 2024 
payment rates for each level of care by the FY 2025 wage index and FY 
2024 payment rates, we obtain a wage index standardization factor for 
each level of care. The wage index standardization factors for each 
level of care are shown in Tables 1 and 2.
    The final FY 2025 RHC rates are shown in Table 9. The final FY 2025 
payment rates for CHC, IRC, and GIP are shown in Table 10.
[GRAPHIC] [TIFF OMITTED] TR06AU24.067


[[Page 64228]]


[GRAPHIC] [TIFF OMITTED] TR06AU24.068

    Sections 1814(i)(5)(A) through (C) of the Act require that hospices 
submit quality data on measures to be specified by the Secretary. In 
the FY 2012 Hospice Wage Index and Rate Update final rule (76 FR 47320 
through 47324), we implemented a Hospice Quality Reporting Program 
(HQRP) as required by those sections. Hospices were required to begin 
collecting quality data in October 2012 and submit those quality data 
in 2013. Section 1814(i)(5)(A)(i) of the Act requires that beginning 
with FY 2014 through FY 2023, the Secretary shall reduce the market 
basket percentage increase by 2 percentage points for any hospice that 
does not comply with the quality data submission requirements with 
respect to that FY. Section 1814(i)(5)(A)(i) of the Act was amended by 
section 407(b) of Division CC, Title IV of the Consolidated 
Appropriations Act (CAA), 2021 (Pub. L. 116-260) to change the payment 
reduction for failing to meet hospice quality reporting requirements 
from 2 to 4-percentage points. Depending on the amount of the annual 
update for a particular year, a reduction of 4 percentage points 
beginning in FY 2024 makes a negative payment update more likely than 
the previous 2 percent reduction. This could result in the annual 
market basket update being less than zero percent for a FY and may 
result in payment rates that are less than payment rates for the 
preceding FY. We applied this policy beginning with the FY 2024 Annual 
Payment Update (APU), which we based on CY 2022 quality data. 
Therefore, the final FY 2025 rates for hospices that do not submit the 
required quality data would be updated by -1.1 percent, which is the 
final FY 2025 hospice payment update percentage of 2.9 percent minus 
four percentage points. Using updated data, these final rates are shown 
in Tables 11 and 12.
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[[Page 64229]]


[GRAPHIC] [TIFF OMITTED] TR06AU24.070

5. Hospice Cap Amount for FY 2025
    As discussed in the FY 2016 Hospice Wage Index and Rate Update 
final rule (80 FR 47183), we implemented changes mandated by the IMPACT 
Act of 2014 (Pub. L. 113-185, Oct. 6, 2014). Specifically, we stated 
that for accounting years that end after September 30, 2016, and before 
October 1, 2025, the hospice cap is updated by the hospice payment 
update percentage rather than using the CPI-U. Division CC, section 404 
of the CAA, 2021 extended the accounting years impacted by the 
adjustment made to the hospice cap calculation until 2030. In the FY 
2022 Hospice Wage Index final rule (86 FR 42539), we finalized 
conforming regulations text changes at Sec.  418.309 to reflect the 
provisions of the CAA, 2021. Division P, section 312 of the CAA, 2022 
(Pub. L. 117-103) amended section 1814(i)(2)(B) of the Act and extended 
the provision that mandates the hospice cap be updated by the hospice 
payment update percentage (the inpatient hospital market basket 
percentage increase reduced by the productivity adjustment) rather than 
the CPI-U for accounting years that end after September 30, 2016 and 
before October 1, 2031. Division FF, section 4162 of the CAA, 2023 
(Pub. L. 118-328) amended section 1814(i)(2)(B) of the Act and extended 
the provision that currently mandates the hospice cap be updated by the 
hospice payment update percentage (the inpatient hospital market basket 
percentage increase reduced by the productivity adjustment) rather than 
the CPI-U for accounting years that end after September 30, 2016 and 
before October 1, 2032. Division G, Section 308 of the Consolidated 
Appropriations Act, 2024 (CAA, 2024) (Pub. L. 118-42) extends this 
provision to October 1, 2033. Before the enactment of this provision, 
the hospice cap update was set to revert to the original methodology of 
updating the annual cap amount by the CPI-U beginning on October 1, 
2032. Therefore, for accounting years that end after September 30, 
2016, and before October 1, 2033, the hospice cap amount is updated by 
the hospice payment update percentage rather than the CPI-U. As a 
result of the changes mandated by the CAA, 2024, we proposed conforming 
regulation text changes at Sec.  418.309 to reflect the revisions at 
section 1814(i)(2)(B) of the Act.
    The proposed hospice cap amount for the FY 2025 cap year was 
$34,364.85, which is equal to the FY 2024 cap amount ($33,494.01) 
updated by the proposed FY 2025 hospice payment update percentage of 
2.6 percent. We also proposed that if more recent data became available 
after the publication of the proposed rule and before the publication 
of the final rule (for example, a more recent estimate of the hospice 
payment update percentage), we would use such data, if appropriate, to 
determine the hospice cap amount in the FY 2025 final rule. As such, 
the hospice cap amount for the FY 2025 cap year is $34,465.34, which is 
equal to the FY 2024 cap amount ($33,494.01) updated by the FY 2025 
hospice payment update percentage of 2.9 percent.
    We received 3 comments on the proposed hospice cap. The following 
is a summary of these comments and our responses:
    Comment: One commenter expressed support for the FY 2025 hospice 
cap.
    Response: We thank the commenter for their support.
    Comment: Two commenters opposed an increase to the hospice cap. One 
commenter recommended the cap remain at the FY 2024 level of $33,494.01 
and one commenter recommended that the cap be lowered for FY 2025.
    Response: We thank the commenters for their recommendations to 
improve the hospice cap; however, we are required by law to update the 
hospice cap amount from the preceding year by the hospice payment 
update percentage, in accordance with section 1814(i)(2)(B)(ii) of the 
Act.
    Final Decision: We are finalizing the update to the hospice cap 
amount for FY 2025 in accordance with statutorily mandated requirements 
and adopting the proposed regulation text change at Sec.  418.309 to 
reflect the revisions at section 1814(i)(2)(B) of the Act, which 
require that, for accounting years that end after September 30, 2016, 
and before October 1, 2033, the hospice cap amount be updated by the 
hospice payment update percentage rather than the CPI-U.

B. Clarifying Regulation Text Changes and Technical Edit

1. Medical Director Condition of Participation
    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 in the interest of the health and safety of

[[Page 64230]]

individuals who are furnished services in an institution, while other 
laws, as outlined below, give CMS the authority to prescribe 
regulations as may be necessary to carry out the administration of the 
program. Section 122 of the Tax Equity and Fiscal Responsibility Act of 
1982 (TEFRA) (Pub. L. 97-248) added section 1861(dd) to the Act to 
provide coverage for hospice care to terminally ill Medicare 
beneficiaries who elect to receive care from a Medicare-participating 
hospice. The CoPs apply to the hospice as an entity, as well as to the 
services furnished to each individual patient under hospice care. In 
accordance with section 1861(dd) of the Act, the Secretary is 
responsible for ensuring that the CoPs are adequate to protect the 
health and safety of the individuals under hospice care.
    Based on feedback from interested parties, including hospice 
providers, national hospice associations, and accrediting 
organizations, we identified discrepancies between the Medical Director 
CoP at Sec.  418.102 and the payment requirements for the 
``certification of the terminal illness'' and the ``admission to 
hospice care'' at Sec.  418.22 and Sec.  418.25, respectively. 
Specifically, the industry questioned the language in the requirements 
as it relates to medical directors in the CoPs, physician designees in 
the CoPs, and physician members of the interdisciplinary group (IDG) in 
the payment requirements. Currently, the medical director provisions in 
the CoPs at Sec. Sec.  418.102(b) and (c) require the medical director 
or physician designee to review the clinical information for each 
patient and provide written certification that it is anticipated that 
the patient's life expectancy is 6 months or less if the illness runs 
its normal course. However, the statutory requirements in sections 
1814(a)(7)(A)(i)(II) and (ii) of the Act and the regulatory payment 
requirements at Sec.  418.22 (Certification of terminal illness) 
provide that the medical director of the hospice or the physician 
member of the hospice interdisciplinary group can certify the patient's 
terminal illness. Although the CoP provisions at Sec. Sec.  418.102(b) 
and (c) include requirements for the initial certification and 
recertification of terminal illness, they do not include the physician 
member of the interdisciplinary group among the types of practitioners 
who can provide these certifications, even though these physicians are 
able to certify terminal illness under the payment regulation at Sec.  
418.22 (Certification of terminal illness).
    This misalignment between the CoPs and the payment requirements has 
caused some confusion for hospice providers, accrediting bodies, and 
surveyors. As a result, we determined that conforming changes to the 
medical director CoP were appropriate for clarity and consistency. To 
align the medical director CoP and the hospice payment requirements, we 
proposed to amend Sec.  418.102(b) by adding the physician member of 
the hospice interdisciplinary group, as defined in Sec.  
418.56(a)(1)(i), as an individual who may provide the initial 
certification of terminal illness. We also proposed to amend the 
medical director CoP in Sec.  418.102(c) to include the medical 
director, or physician designee, as defined at Sec.  418.3, if the 
medical director is not available, or physician member of the IDG among 
the specified physicians who may review the clinical information as 
part of the recertification of the terminal illness.
    We refer readers to section III.B.2 of this final rule for comments 
and responses received on the proposed payment regulation changes 
regarding the certification of the terminal illness and admission to 
hospice care under Sec. Sec.  418.22 and 418.25, which are also 
intended to align the medical director CoP and payment regulations.
    In this section, we discuss the public comments received on the 
alignment of language in the existing requirements for hospices 
regarding the medical director, physician designee, and physician 
member of the IDG.
    We received a total of 27 comments from individuals, health care 
professionals, and national associations that expressed general support 
and appreciation for the proposed alignment of language used in the 
CoPs with the language in the corresponding payment policy. Commenters 
highlighted how the clarification would reduce variability and 
confusion related to who provides certification of terminal illness. 
Additionally, commenters noted that the clarification supports hospice 
providers and audit contractors and ensures continued care for 
patients. The following is a summary of the comments we received, our 
responses, and the policies we are finalizing.
    Comment: Multiple commenters expressed support and appreciation for 
our proposal to align the CoPs at Sec.  418.102 with the payment policy 
language at Sec. Sec.  418.22(c) and 418.25, stating that these changes 
would allow for greater clarity and consistency between key components 
of the hospice requirements. Commenters also stated the misalignment 
between the CoPs and the payment requirements has caused some confusion 
for hospice providers, accrediting bodies, and surveyors and that the 
proposed conforming changes to the medical director CoP and the payment 
requirements would result in more clarity and consistency for hospices.
    Response: We appreciate the supportive feedback from commenters 
regarding the alignment of language in the CoPs with language in 
payment policy.
    Comment: Several commenters expressed support for the proposed 
alignment of the CoPs with the payment policy and recommended further 
language alignment in the standards for the Medical Director in the 
hospice CoPs at Sec.  418.102. Specifically, they recommended that we 
replace the terms ``physician designated by'' with ``physician 
designee'' in the CoP at Sec.  418.102, which states, ``When the 
medical director is not available, a physician designated by the 
hospice assumes the same responsibilities and obligations as the 
medical director.'' Commenters noted that this would align with the 
existing terminology used throughout the requirements.
    Response: We appreciate the commenters' support and recommendation 
to further modify the introductory language in the medical director CoP 
at Sec.  418.102. We agree with the commenters' recommendation to align 
this first paragraph of the medical director CoP by replacing 
``physician designated by'' with ``physician designee'' to align the 
terminology used through the requirements.
    Final Decision: After consideration of public comments on this 
provision, we are finalizing the requirements at Sec.  418.102(b) and 
Sec.  418.102(c) as proposed. In addition, we are modifying Sec.  
418.102 by removing the phrase ``physician designated by'' and 
replacing it with ``physician designee as defined at Sec.  418.3''. The 
definition of ``physician designee'' at Sec.  418.3 is defined as, ``. 
. . a doctor of medicine or osteopathy designated by the hospice who 
assumes the same responsibilities and obligations as the medical 
director when the medical director is not available.'' We are 
finalizing revisions to the medical director standard to state, ``The 
hospice must designate a physician to serve as medical director. The 
medical director must be a doctor of medicine or osteopathy who is an 
employee, or is under contract with the hospice. When the medical 
director is not available, a physician designee as defined at Sec.  
418.3, assumes the same responsibilities and obligations as the medical 
director.'' Lastly, we are

[[Page 64231]]

revising the standards for initial certification of terminal illness 
and recertification of terminal illness at Sec.  418.102(b) and Sec.  
418.102(c), respectively, to provide in a parenthetical that physician 
designee, as defined at Sec.  418.3, can conduct the review of clinical 
information and certification or recertification if the medical 
director is unavailable.
    We believe this modification will provide consistency and alignment 
in the payment and CoP requirements. These changes align the payment 
requirements and the health and safety requirements such that there 
will be consistency across the requirements for hospices, resulting in 
improved compliance and clearer enforcement activities.
2. Certification of Terminal Illness and Admission to Hospice Care
    The Medicare hospice benefit provides coverage for a comprehensive 
set of services described in section 1861(dd)(1) of the Act for 
individuals who are deemed ``terminally ill'' based on a medical 
prognosis that the individual's life expectancy is 6 months or less, as 
described in section 1861(dd)(3)(A) of the Act.
    As such, section 1814(a)(7)(A) of the Act requires the individual's 
attending physician (if the patient designates an attending physician) 
and hospice medical director or physician member of the IDG to certify 
in writing at the beginning of the first 90-day period of hospice care 
that the individual is ``terminally ill'' based on the physician's or 
medical director's clinical judgment regarding the normal course of the 
individual's illness. In a subsequent 90- or 60-day period of hospice 
care, only the hospice medical director or the physician member of the 
IDG is required to recertify at the beginning of the period that the 
patient is terminally ill based on such clinical judgment.
    The CoPs at Sec.  418.102 state that ``when the medical director is 
not available, a physician designated by the hospice assumes the same 
responsibilities and obligations as the medical director.'' The term 
``physician designee'' was utilized in the 1983 hospice final rule (48 
FR 56029) that implemented the Medicare hospice benefit when describing 
who can establish and review the hospice plan of care and was later 
defined and finalized in the FY 2008 hospice final rule (73 FR 32093) 
in response to comments requesting CMS clarify this individual's role. 
Section 418.3 defines ``physician designee'' to mean a doctor of 
medicine or osteopathy designated by the hospice who assumes the same 
responsibilities and obligations as the medical director when the 
medical director is not available. Currently, the requirements at Sec.  
418.22(c), Sources of Certification, state that for the initial 90-day 
period, the hospice must obtain written certification statements from 
the medical director of the hospice or the physician member of the IDG 
and the individual's attending physician if the individual has an 
attending physician. For subsequent periods, only the ``medical 
director of the hospice or the physician member of the 
interdisciplinary group'' must certify terminal illness. Similarly, the 
requirements at Sec.  418.22(b), Content of Certification, only include 
the ``the physician's or medical director's'' when referencing the 
clinical judgment on which the certification must be based. 
Additionally, Sec.  418.25, Admission to Hospice Care, only refers to 
the recommendation of the hospice medical director (in consultation 
with the patient's attending physician (if any)) when determining 
admission to hospice and when reaching a decision to certify that the 
patient is terminally ill. We note that in the preamble of the proposed 
rule, we inadvertently referred to paragraph (b) of Sec.  418.22 as the 
paragraph we proposed to amend. However, the proposed amendment to the 
text of the regulation was to paragraph (c) of Sec.  418.22. We refer 
in the preamble to this final rule to the correct paragraph of Sec.  
418.22, which is paragraph (c), not paragraph (b).
    In order to align Sec. Sec.  418.22(c) and 418.25 with the CoPs at 
Sec.  418.102, we proposed to add ``physician designee (as defined in 
Sec.  418.3)'' to clarify that when the medical director is not 
available, a physician designated by the hospice, who is assuming the 
same responsibilities and obligations as the medical director, may 
certify terminal illness and determine admission to hospice care. We 
clarified that this does not connote a change in policy; rather, we 
believe aligning the language at Sec. Sec.  418.22(c) and 418.25 with 
the CoPs at Sec.  418.102 allows for greater clarity and consistency 
between key components of hospice regulations and policies.
    We received 29 comments on these proposed clarifying hospice 
regulation text changes. A summary of the comments and our responses to 
those comments are as follows:
    Comment: All commenters supported the clarifying regulation text 
changes and applauded CMS for the clarification and consistency between 
key components of the hospice regulations. Commenters stated that the 
clarification will help simplify language, reduce confusion among 
stakeholders (that is, hospice providers, CMS audit contractors, and 
Medicare Administrative Contractors (MACs)), and protect hospices 
against inappropriate citations.
    Response: We thank commenters for their support.
    Comment: Several commenters requested ``physician member of the 
interdisciplinary group'' be added to Sec.  418.25 to further reduce 
confusion and provide clarity regarding the hospice admission process. 
Additionally, one commenter requested that nurse practitioners (NPs) 
and physician assistants (PAs) be allowed to certify a beneficiary as 
terminally ill and be included on initial hospice certifications.
    Response: We thank commenters for their recommendations; however, 
adding ``physician member of the interdisciplinary group'' to Sec.  
418.25 would be a substantive policy change and the proposals included 
in the proposed rule were intended only to clarify existing policy. 
Additionally, allowing NPs and PAs to certify a beneficiary as 
terminally ill is not permitted under the statute.
    Final Decision: We are finalizing the regulation text revisions to 
add ``physician designee (as defined in Sec.  418.3)'' at Sec. Sec.  
418.22(c) and 418.25 as proposed.
3. Election of Hospice Care
    A distinctive characteristic of the Medicare hospice benefit is 
that it requires a patient (or their representative) to intentionally 
choose hospice care by electing the benefit. As part of the election 
required by Sec.  418.24, a beneficiary (or their representative) must 
file an ``election statement'' with the hospice, which must include an 
acknowledgement that they fully understand the palliative, rather than 
curative, nature of hospice care as it relates to the individual's 
terminal illness and related conditions, as well as other requirements 
as set out at Sec.  418.24(b). Additionally, as set out at Sec.  
418.24(f), when electing the hospice benefit, an individual waives all 
rights to Medicare payment for any care for the terminal illness and 
related conditions except for services provided by the designated 
hospice, another hospice under arrangement with the designated hospice, 
and the individual's attending physician if that physician is not an 
employee of the designated hospice or receiving compensation from the 
hospice for those services. Because of this waiver, this means that the 
designated hospice is the only provider to which Medicare payment can 
be

[[Page 64232]]

made for services related to the terminal illness and related 
conditions for the patient; providers other than the designated 
hospice, a hospice under arrangement with the designated hospice, or 
the individual's attending physician cannot receive payment for 
services to a hospice beneficiary unless those services are unrelated 
to the terminal illness and related conditions when a patient is under 
a hospice election.
    In the FY 2015 Hospice Wage Index and Payment Rate Update final 
rule (79 FR 50452, 50478), we finalized a requirement that a Notice of 
Election (NOE) must be filed with the hospice MAC within five calendar 
days after the effective date of hospice election. If the NOE is filed 
beyond this timeframe, hospice providers are liable for the services 
furnished during the days from the effective date of hospice election 
to the date of NOE filing (79 FR 50478). Also, because non-hospice 
providers may be unaware of a hospice election, late filing of the NOE 
leaves Medicare vulnerable to paying non-hospice claims related to the 
terminal illness and related conditions when these services are 
furnished by these non-hospice providers. Moreover, beneficiaries may 
potentially be liable for any associated cost-sharing they would not 
have incurred if these services were furnished by the hospice provider.
    When discussing hospice election, stakeholders (such as Medicare 
contractors, medical reviewers, and hospices) often conflate the terms 
``election statement'' and ``NOE.'' Further, we have received recent 
inquiries requesting clarification on timeframe requirements for both 
the election statement and the NOE that indicate confusion between such 
documents. Upon review of this regulation, we believe the organization 
at Sec.  418.24 does not make it clear that these are two separate and 
distinct documents intended for separate purposes under the benefit. We 
proposed to reorganize the language in this section to clearly denote 
the differences between the election statement and the NOE. That is, we 
proposed to title Sec.  418.24(b) as ``Election Statement'' and would 
include the title ``Notice of Election'' at Sec.  418.24(e). We stated 
that by clearly titling this section, the requirements for the election 
statement and the notice of election would be distinguished from one 
another, mitigating any confusion between the two documents. These 
changes would align with existing subregulatory guidance. We also noted 
this reorganization would not be a change in policy, rather it is 
intended to identify the requirements more clearly for the election 
statement and the NOE by reorganizing the structure of the regulations. 
We believe this reorganization is important to ensure that stakeholders 
fully understand that the election statement is required as 
acknowledgement of a beneficiary's understanding of the decision to 
elect hospice and filed with the hospice, whereas the NOE is required 
for claims processing purposes and filed with the hospice MAC within 
five calendar days after the effective date of the election statement.
    We also noted that the MACs have informed us of ongoing instances 
of hospices omitting certain elements of the hospice election 
statement. We reminded readers that a complete election statement 
containing all required elements as set forth at Sec.  418.24(b) is a 
condition for payment. Additionally, we emphasized the importance of 
each element in informing the beneficiary of their coverage when 
choosing to elect the Medicare hospice benefit. We continued to 
encourage hospice agencies to utilize the ``Model Example of Hospice 
Election Statement'' on the hospice web page at <a href="https://www.cms.gov/medicare/payment/fee-for-service-providers/hospice">https://www.cms.gov/medicare/payment/fee-for-service-providers/hospice</a> to limit potential 
claims denials.
    We received 21 comments on the proposed clarification of the 
election statement and the NOE. A summary of the comments and our 
responses to those comments are as follows:
    Comment: All commenters supported the reorganization and 
clarification of the election statement and the NOE and expressed 
appreciation that CMS is working to mitigate confusion between the two 
documents and promoting clarity. Other commenters stated that the 
changes are helpful in clarifying key components of the hospice 
regulations for hospice providers, Administrative Law Judges (ALJs), 
CMS audit contractors, MACs, and other stakeholders.
    Response: We thank commenters for their support.
    Comment: We received four comments on the reference to the model 
election statement and a concern that the MACs are treating the model 
election statement example as a required form despite CMS instruction 
that the model election statement is intended to be an example of a 
form agencies can utilize if desired. Specifically, a few commenters 
reported receiving ``technical denials'' from MACs when specific 
language or organization did not match the election statement example. 
Lastly, a commenter suggested that CMS conduct an analysis of 
overturned claim denials to improve audit activity.
    Response: We thank the commenters for their feedback. We reiterate 
that the model election statement is intended to be an example of a 
form that hospices may utilize and that hospice agencies are not 
required to use this exact example. We appreciate the suggestion to 
analyze overturned claim denials in order to improve future audit 
activity.
    Comment: One commenter recommended the physician national provider 
identifier (NPI) number be included on the model hospice election 
statement.
    Response: We thank the commenter for the suggestion. A provider may 
add additional information, such as an NPI number, to their own 
election statement; however, we do not want providers to infer the NPI 
is required under Sec.  418.24(b), and as such, will not add it to the 
model election statement at this time.
    Final Decision: We are finalizing the regulation text revisions to 
reorganize and clarify the election statement and the NOE requirements 
at Sec.  418.24 as proposed.
4. Hospice Marriage and Family Therapist Technical Edit
    In the final rule that appeared in the November 16, 2023 Federal 
Register on (88 FR 78818) titled ``Medicare and Medicaid Programs; CY 
2024 Payment Policies Under the Physician Fee Schedule and Other 
Changes to Part B Payment and Coverage Policies; Medicare Shared 
Savings Program Requirements; Medicare Advantage; Medicare and Medicaid 
Provider and Supplier Enrollment Policies; and Basic Health Program'' 
there is one technical error noted in the hospice personnel 
requirements at Sec.  418.114(b)(9) that is identified and corrected in 
this final rule.
    Throughout the final rule (88 FR 78818) we correctly used the term 
``marriage and family therapist.'' However, on page 79539 under Sec.  
418.114(b)(9) of the final rule, we inadvertently finalized regulation 
text that uses the term ``marriage and family counselor'' when the 
correct term is ``marriage and family therapist.'' Therefore, we are 
making a technical correction in this final rule by replacing 
``marriage and family counselor'' with ``marriage and family 
therapist'' at Sec.  418.114(b)(9).

[[Page 64233]]

C. Request for Information (RFI) on Payment Mechanism for High 
Intensity Palliative Care Services

    We define hospice care as a set of comprehensive services described 
in section 1861(dd)(1) of the Act, identified and coordinated by an IDG 
to provide for the physical, psychosocial, spiritual, and emotional 
needs of a terminally ill patient and/or family members, as delineated 
in a specific patient plan of care (Sec.  418.3). Hospice care changes 
the focus of a patient's illness to comfort care (palliative care) for 
pain relief and symptom management from a curative type of care. Under 
the hospice benefit, palliative care is defined as patient and family 
centered care that optimizes quality of life by anticipating, 
preventing, and treating suffering (Sec.  418.3). Palliative care 
throughout the continuum of illness involves addressing physical, 
intellectual, emotional, social, and spiritual needs and facilitating 
patient autonomy, access to information, and choice. CMS continually 
works to ensure access to quality hospice care for all eligible 
Medicare beneficiaries by establishing, refining, readapting, and 
reinforcing policies to improve the value of care at the end of life 
for these beneficiaries. That is, we seek to strengthen the notion that 
in order to provide the highest level of care for hospice 
beneficiaries, we must provide ongoing focus on those services that are 
consistent with CMS' definitions of hospice and palliative care and 
eliminate any barriers to accessing hospice care.
    Adequate care under the hospice benefit has consistently been 
associated with symptom reduction, less intensive care, decreased 
hospitalizations, improved outcomes from caregivers, lower overall 
costs, and higher alignment with patient preferences and family 
satisfaction.\5\ Although hospice use has grown considerably since the 
inception of the Medicare hospice benefit in 1983, there are still 
barriers that terminally ill and hospice benefit eligible beneficiaries 
may face when accessing hospice care. Specifically, the national trends 
\6\ that examine hospice enrollment and service utilization for those 
beneficiary populations with complex palliative needs and potentially 
high-cost medical care needs reveal that there may be an underuse of 
the hospice benefit, despite the demonstrated potential to both improve 
quality of care and lower costs.\7\
---------------------------------------------------------------------------

    \5\ Obermeyer Z, Makar M, Abujaber S, Dominici F, Block S, 
Cutler DM. Association Betweeen the Medicare Hospice Benefit and 
Health Care Utilization and Costs for Patients With Poor-Prognosis 
Cancer. JAMA.2014;312(18): 1888-1896. doi:10.1001/jama.2014.14950.
    \6\ Wachterman MW, Hailpern SM, Keating NL, Kurella Tamura M, 
O'Hare AM. Association Between Hospice Length of Stay, Health Care 
Utilization and Medicare Costs at the End of Life Among Patients Who 
Received Maintenance Hemodialysis. JAMA Intern Med. 2018 Jun 
1;178(6):792-799. doi:10.1001/jamainternmed.2018.0256. PMID; 
29710217; PMCID: PMC5988968.
    \7\ Meier DE. Increased access to palliative care and hospice 
services: opportunities to improve value in health care. Milbank Q. 
2011 Sep;89(3):343-80. doi: 10.1111/j.1468-0009.2011.00632.x. PMID: 
21933272; PMCID:PMC3214714.
---------------------------------------------------------------------------

    There is a subset of hospice eligible beneficiaries that would 
likely benefit from receiving palliative, rather than curative, 
chemotherapy, radiation, blood transfusions, and dialysis. Anecdotally, 
we have heard from beneficiaries and families their understanding that 
upon election of the hospice benefit, certain therapies such as 
dialysis, chemotherapy, radiation, and blood transfusions are not 
available to them, even if such therapies would provide palliation for 
their symptoms. Generally, these patients report that they have been 
told by hospices that Medicare does not allow for the provision of 
these types of treatments upon hospice election. While these types of 
treatments are not intended to cure the patient's terminal illness, 
some practitioners, with input from the hospice IDG, may determine 
that, for some patients, these adjuvant treatment modalities would be 
beneficial for symptom control. In such instances, these palliative 
treatments would be covered under the hospice benefit because they are 
not intended to be curative. In the FY 2024 Hospice final rule (88 FR 
51168), we noted in response to our RFI on hospice utilization; non-
hospice spending; ownership transparency; and hospice election 
decision-making, that commenters stated providing complex palliative 
treatments and higher intensity levels of hospice care may pose 
financial risks to hospices when enrolling such patients. Commenters 
stated that the current bundled per diem payment is not reflective of 
the increased expenses associated with higher-cost and certain patient 
subgroups. As we continue to focus on improved access and value within 
the hospice benefit, we solicited additional information on the 
potential implementation of a payment mechanism to account for the 
increased costs of providing more intensive palliative treatments.
    We received approximately 60 comments on our RFI on high-cost 
palliative services. Most of the comments we received included both 
general recommendations as well as specific comments in response to the 
questions asked in the proposed rule. Therefore, we summarize general 
comments, followed by specific comments we received in response to each 
question presented in the proposed rule.
    Comment: A few commenters suggested that, to minimize the 
complexity of the topic and prior to consideration of RFI responses, 
CMS should first avoid using ``comfort care'' interchangeably with 
``palliative care'', clearly distinguish between ``hospice care'' and 
``palliative care'', and remove the term ``palliative'' altogether and 
replace it with ``high-cost therapies''. Many commenters stated there 
is an underutilization of the hospice benefit, in part due to the 
availability of high-cost, intensive services outside of the hospice 
benefit (that is services covered under another Medicare benefit, such 
as ESRD). For example, several commenters stated that patients often 
choose not to elect hospice, or they elect later in the trajectory of 
their illness, as they would need to give up the option for many of the 
palliative but higher cost treatments. This often results in patients 
electing hospice services in the final days or weeks of their lives 
when the patient and their families do not receive the full benefit of 
hospice. Several anecdotal stories were provided in support of 
continuing these high-cost services, particularly home blood 
transfusions, and often these were provided to align with patient goals 
at end of life. A few commenters stated the issue is not a lack of 
access to these services, but rather hospices' decisions that the costs 
of these services are prohibitive. A few commenters expressed concern 
about potential fraudulent activity by certain providers if a separate 
payment mechanism was established and suggested that CMS should first 
identify gaps in care and potential fraud, waste, and abuse. The 
commenters recommended incentivizing advance care planning, as well as 
monitoring and enforcing appropriate provisions of the hospice benefit. 
Another commenter stated the financial impact is not the only concern 
for electing hospice; they stated that there can be a concern related 
to a patient's prognosis and understanding palliative treatment versus 
a reluctance to forgo a plan to continue curative treatment. The 
commenter recommended CMS consider the roles of specialists 
(oncologists, hematologists, etc.) when determining the impact of this 
potential policy on the hospice

[[Page 64234]]

philosophy of reducing patients' suffering as well as the requirement 
to determine a life expectancy of six-months or less. Some commenters 
requested that CMS consider additional data mining to determine whether 
high intensity, high-cost palliative treatments are offered more 
frequently during the course of a hospice stay versus upon admission 
when conflicting goals of the medical providers are more obvious. 
Lastly, a commenter recommended better electronic medical record (EMR) 
coordination and interoperability between the hospice teams and 
specialists to ensure all potential treatments are communicated. 
Multiple commenters, including several national organizations, stated 
concern that under the current statutory budget neutrality requirement, 
the introduction of any new payment would have to be offset by 
reductions to existing payments. Commenters stated they do not believe 
this is tenable given hospices' financial pressures and the challenges 
they already experience paying for high-intensity palliative services 
under the current reimbursement rates. Likewise, a few commenters 
stated that smaller and non-profit hospices disproportionately tend to 
care for the sickest patients who often require these types of high-
intensity services, and the costs associated with providing these 
higher-intensity services are too often prohibitive, particularly for 
these small hospices and non-profit hospices. Commenters expressed 
concern that any changes implemented under CMS' current statutory 
authority would not sufficiently address this issue. These commenters 
recommended CMS work with industry stakeholders to pursue legislative 
authority from Congress to create a payment policy to ensure that 
hospice patients have adequate access to high intensity palliative care 
services. In addition, commenters recommended CMS convene a Technical 
Expert Panel (TEP) in conjunction with robust data collection to be 
able to advance those discussions. For robust data collection, several 
commenters recommended gathering comprehensive data on historic and 
current beneficiary utilization of high-cost palliative interventions 
for hospice and hospice-eligible patients, conducting an analysis of 
any specific barriers impacting access to these services throughout the 
care continuum, and developing rules, protocols, and sustainable 
payment avenues for these kinds of treatments to improve access to 
hospice for traditionally underserved patients and families that come 
from diverse racial and ethnic backgrounds.
    MedPAC reported it plans to conduct research regarding access to 
hospice and end-of-life care for beneficiaries with End Stage Renal 
Disease (ESRD), interviewing clinicians; hospice providers; and ESRD 
facilities, including programs that provide palliative kidney care, and 
other groups.
    A few commenters recommended providing further education and 
clarity to providers and new hospice enrollees upfront to promote a 
better understanding of the coverage policy regarding the 
appropriateness of the use of high intensity palliative care services 
in conjunction with traditional hospice services. These commenters also 
recommended CMS issue guidance, rules, or incentives that make it 
easier for hospices to secure contracts with the upstream providers of 
these services. Several commenters recommended implementing measures to 
reduce administrative burden to hospices for these high-cost services.
    We received a comment that greater utilization of physician 
assistants (PAs) has the potential to reduce care barriers and move 
toward ameliorating the problem of eligible beneficiaries not 
sufficiently accessing hospice services, including high-cost palliative 
services. The commenter recommended modifying the hospice regulations 
and the Medicare Benefit Policy Manual to authorize PAs employed by the 
hospice to serve in the role of a patient's attending physician if an 
attending physician was not previously selected by the patient.
    Below are the questions we posed in RFI in the proposed rule, along 
with the comment summaries.
    What could eliminate the financial risk commenters previously noted 
when providing complex palliative treatments and higher intensity 
levels of hospice care?
    Comment: Several commenters strongly supported a more robust 
payment for high intensity palliative care services to help cover the 
costs. Specifically, we received multiple comments stating that if all 
hospices are expected to regularly provide complex palliative 
treatments and higher intensity levels of hospice care, additional 
payment or a higher daily per diem rate must be provided for patients 
receiving these complex, high-cost treatments. Commenters stated higher 
payment rates, add-on payments, or an outlier payment would allow 
hospice agencies to provide the additional treatments and staff to 
support higher intensity care without having significant financial 
burdens. Specifically, commenters suggested additional payments for 
staff training and resource support to sufficiently ensure skills to 
deliver high-quality, complex care and staff retention to support 
quality patient outcomes and cost-effective care delivery.
    Commenters stated these extra payments should not only include the 
cost of the service or item itself, but also costs associated with the 
care management and coordination activities such as monitoring, 
mapping, office visits, repeat imaging, and transportation. Commenters 
recommended various modifiers or ``payment tiers'' to reflect the 
intensity of services or resource utilization, and suggested CMS 
analyze the cost of care for various services to determine individual 
payment tiers, as well as implementing a ``cap'' for these higher 
intensity service payments.
    Other commenters opposed additional payment under the hospice 
benefit and multiple commenters recommended some version of a carve out 
or concurrent care payments. We received several comments recommending 
different payment models including adopting the Medicare Care Choices 
Model (MCCM) or a modified version of the MCCM and reviving and 
expanding the Medicare Coordinated Care Demonstration (MCCD). Many 
commenters stated that CMS should not attempt to cover these high-cost 
services within the existing hospice benefit payment structure, rather 
specialty providers should be able to bill Medicare Part B directly 
while the patient remains under a hospice plan of care. These 
commenters recommended CMS permit conditioned access to these 
treatments for beneficiaries concurrently enrolled in hospice and 
develop new policy and payment guidelines for the specialty 
practitioners. They suggested these practitioners could use modifiers 
and advised limiting the number of treatments while patients are under 
a hospice election. Some commenters recommended that the concurrent 
care payment for high-cost palliative treatments only be available 
during the first benefit period.
    A few commenters recommended that in addition to covering high-cost 
treatments and their related medications, it would also be beneficial 
for Medicare to cover high-cost medications unrelated to higher 
intensity services (for example, novel oral anticoagulants, certain 
inhalers, antibiotics, other medications typically used for curative 
purposes) when provided with palliative intent.
    What specific financial risks or costs are of particular concern to 
hospices that would prevent the provision of higher-cost palliative 
treatments when

[[Page 64235]]

appropriate for some beneficiaries? Are there individual cost barriers 
which may prevent a hospice from providing higher-cost palliative care 
services? For example, is there a cost barrier related to obtaining the 
appropriate equipment (for example, dialysis machine)? Or is there a 
cost barrier related to the treatment itself (for example, obtaining 
the necessary drugs or access to specialized staff)?
    Comment: Almost all commenters provided specific financial risks 
and cost barriers to providing higher-cost palliative care services. 
Commenters stated that across all diagnoses and situations there is a 
wide variance of incremental costs involved in higher intensive care. 
Commenters described barriers related to both direct and ancillary 
costs. The most cited expenses included the treatment itself, staffing, 
equipment, transportation logistics, contracting, facility usage, and 
administrative burden.
    Many commenters stated these palliative treatments require the use 
of high-cost drugs, which represent a significant proportion of the 
cost. Commenters noted even medications covered by Medicare Part D 
prior to hospice election continue to prove challenging for hospices to 
manage. Commenters stated that these high-cost palliative treatments 
can also require additional medications to address burdensome side 
effects and symptoms of the interventions themselves. Several 
commenters recommended developing a national formulary with negotiated 
rates that hospices could use to procure medications or seek to 
leverage Veterans Affairs pharmacy contracts. Alternatively, one 
commenter noted that while the equipment required for these services 
will still be needed, some of the drugs and related supplies (for 
bundled and separately payable drugs) and labs could potentially be 
discontinued or reduced, as they may not support the goals of comfort 
at the end of life.
    Commenters also stated many of these treatments require specialized 
staff, such as oncologists, nephrologists, and trained nurses who have 
the expertise to administer complex treatments like chemotherapy and 
dialysis. Commenters noted the salaries and benefits for these 
specialized professionals are higher than for general hospice staff, 
adding to the financial burden on hospices. In addition, existing 
hospice staff may need additional training and certifications to 
understand and/or help administer and educate patients and families on 
these interventions and their side effects. Commenters stated the costs 
associated with staff training can include course fees, travel, and 
time away from regular duties which can present a significant barrier. 
Commenters also stated these high intensity patients also typically 
require more frequent medication adjustments requiring more frequent 
provider and nursing visits, which increases the financial burden. A 
commenter noted for many of these services, there is also an increased 
complexity for the caregiver at home, therefore there can be a greater 
need for respite and GIP care.
    Several commenters stated that the cost of specialized equipment 
can vary depending on the treatment provided. Although one commenter 
said it is unlikely that a hospice would obtain the necessary 
equipment, such as a dialysis machine, as it is available in most 
communities, many commenters raised issues securing contracts with 
specialty providers and hospitals or other facilities where these 
treatments are administered. Commenters also stated the contracting and 
payment processes for these services would be an uncharted and 
potentially confusing process for the hospices and specialty providers 
alike. In addition, commenters stated hospice providers are unable to 
negotiate contracts at Medicare allowable rates for these related 
services, and therefore providers of these high-cost palliative 
treatments may be reluctant to reduce costs for hospices compared to 
other existing reimbursement rates. A few commenters noted that even if 
a contract is in place, there may be a lack of access to beds and 
treatments when needed.
    Commenters also stated a potential burden with care management, 
such as coordination with the facilities where these treatments are 
delivered and with the providers who deliver them. Commenters reported 
that hospices can dedicate signi[filig]cant resources when arranging 
for high-intensity services including labs, imaging, and transportation 
for patients and family to a location where these high-cost treatments 
are administered. One commenter also stated patients and their 
specialty providers, not the hospice provider, decide where to receive 
treatment, and that beneficiaries may choose to continue receiving 
dialysis from their current provider, rather than the hospice-
contracted provider.
    A commenter also reported that regulatory burdens related to 
compliance requirements governing the provision of complex palliative 
treatments may add administrative burden and costs to the agency. 
Overall, commenters stated the complexity and variability of these 
costs, coupled with uncertainties in reimbursement rates for such 
services, pose significant barriers for hospices to offer them 
routinely.
    Should there be any parameters around when palliative treatments 
should qualify for a different type of payment? For example, we are 
interested in understanding from hospices who do provide these types of 
palliative treatments whether the patient is generally in a higher 
level of care (CHC, GIP) when the decision is made to furnish a higher-
cost palliative treatment? Should an additional payment only be 
applicable when the patient is in RHC?
    Comment: Most commenters stated CMS should not limit higher 
reimbursement for complex treatments to certain types of patients. 
Commenters stated that patients at any level of care could benefit from 
a high-cost palliative service and that such service should not only be 
provided to patients in a higher level of care.
    Several commenters stated that the use of these services does not 
necessarily correlate to a need for a higher intensity level of hospice 
care and therefore, beneficiaries do frequently remain at an RHC level. 
For example, a commenter stated that beneficiaries with uncontrolled 
symptoms and at the CHC or GIP level of care are unlikely to be 
candidates for receiving these high intensity services as these 
services are intended for long-term symptom management rather than 
acute symptom management. However, several commenters stated there are 
times when a patient might be eligible for a higher level of care for 
reasons unrelated to the administration of the high intensity 
palliative services, but that high intensity service might still be 
appropriate.
    Commenters also reported that symptom burden can also result in the 
need for GIP or CHC and providing a higher intensity palliative 
treatment during RHC may reduce or eliminate the need for this higher 
level of care.
    We received a few comments in support of establishing parameters 
around these high-cost palliative services. These commenters 
recommended that payment for higher cost palliative treatments should 
be subject only to the determination based on the ability to improve 
the person's quality of life. That is, these treatments should only be 
utilized by a hospice beneficiary expressly for palliative purposes as 
evidenced by current clinical guidelines for the treatment's 
utilization as palliative care. Another commenter stated guidelines for 
additional payments should be based upon identified symptom burden that 
would reasonably be expected to be

[[Page 64236]]

relieved or managed by the palliative intervention with specified 
outcomes.
    Another commenter stated that moving to a higher level of care (for 
example, GIP, CHC) could trigger higher cost palliative treatments or 
that these patients may need a higher level of monitoring and would 
therefore be expected to be in GIP or CHC while receiving these 
treatments.
    Under the hospice benefit, palliative care is defined as patient 
and family centered care that optimizes quality of life by 
anticipating, preventing, and treating suffering (Sec.  418.3). In 
addition to this definition of palliative care, should CMS consider 
defining palliative services, specifically regarding high-cost 
treatments? Note, CMS is not seeking a change to the definition of 
palliative care, but rather should CMS consider defining palliative 
services with regard to high-cost treatments?
    Comment: A few commenters stated it can be easy to misconstrue the 
use of high-cost services, as the intent, dose, duration, or stage of 
the illness can dictate whether these services are palliative or 
curative. Additionally, commenters recommended first considering how 
palliative care fits within the current hospice benefit especially if 
palliative care is life prolonging. Another commenter recommended any 
palliative definitions should align with the Center to Advance 
Palliative Care (CPAC) definitions related to palliation.
    We received multiple comments in support of defining palliative 
services, particularly for additional reimbursement. Commenters in 
support of a definition of palliative services stated it could help 
provide clarity, standardization, and understanding about the types of 
services that would be included under this potential additional payment 
category which could help promote equity in patient care. Commenters 
stated a definition of palliative services should characterize these 
services as resource intensive services that are independent of 
curative treatments. A few commenters, while in support of a 
definition, also cautioned that any definition should be broad enough 
so as not to inadvertently exclude certain services. For example, 
commenters stated the definition should not specify individual drugs, 
durable medical equipment (DME), or other therapies, to allow for 
separate billing for these items. Another commenter stated a definition 
of palliative services should be specific to services offered under the 
Medicare hospice benefit, to eliminate potential confusion that this 
would be a separate palliative care benefit. Lastly, some commenters in 
support of defining palliative services stated establishing specific 
criteria can help prevent overuse or misuse of expensive treatment, as 
well as allow hospices to better plan financially and ensure they are 
adequately compensated for providing these complex and expensive 
services.
    We also received multiple comments in opposition of defining 
palliative services. These commenters stated defining services that 
could be disease-modifying as palliative is a dynamic area and instead 
treatments should be determined on an individual patient basis rather 
than explicitly defining palliative services. Commenters stated a 
flexible approach is needed, as patient and family goals and needs are 
highly specific and medical advances in the future could result in as-
yet unidentified treatments that could be considered ``palliative 
services.'' A few commenters stated defining palliative services would 
be a substantial undertaking that would require broad stakeholder 
engagement, as narrowing the definition of palliative care based on 
certain services would likely lead to additional confusion and 
administrative burden. As such, any definition of ``palliative 
services'' as separate from the definition of palliative care should be 
focused on facilitating understanding of payment of these services.
    Should there be documentation that all other palliative measures 
have been exhausted prior to billing for a payment for a higher-cost 
treatment? If so, would that continue to be a barrier for hospices?
    Comment: Commenters stated the focus should be on the goals and 
quality of life for beneficiaries. They stated that physicians' 
clinical judgment should be the basis to determine if such treatment is 
necessary and beneficial to the patient. Commenters raised concerns 
that requiring all other palliative measures be exhausted prior to 
billing for a higher-cost treatment is nebulous and could be a barrier 
to patient care. Multiple commenters stated, while the rationale for 
billing for a higher-cost treatment should be documented in the record, 
they oppose additional requirements to document that all other 
palliative measures have been exhausted prior to billing for a higher-
cost service. They stated this could lead to inefficiencies, 
administrative burden, unnecessary services, delays in hospice 
admissions leading to shorter lengths of hospice stays, and delays in 
the relief of symptoms. Commenters also stated that time spent trying 
other, potentially lower cost but ineffective interventions before 
utilizing the higher cost treatment will raise total costs for these 
patients and extend the time they are not receiving proper care for 
their condition(s). Commenters also stated as treatment decisions are 
often made urgently, CMS should limit the barriers to the use of 
complex treatments. And finally, commenters stated this could undermine 
the clinical judgment of the hospice IDG and upstream providers and 
lead to fear of retrospective audits questioning the clinical 
appropriateness of providing one treatment instead of another. These 
commenters stated that determining when all other measures have been 
exhausted may be clinically subjective and challenging, leading to 
variations in interpretation and exacerbating delays in treatment or 
claims denials.
    Other commenters stated that the use of complex treatments is 
individualized and should be used only if all other treatments have 
been tried. Commenters recommended that documentation should include 
the symptoms being addressed, the treatments that have been tried 
unsuccessfully, and the plan for using a particular complex treatment. 
Some commenters stated that requiring documentation that all other 
palliative measures have been exhausted prior to billing ensures high-
cost treatments are used as a last resort and maintains cost-
effectiveness and appropriate resource allocation; however, as this 
could be a huge barrier to hospice providers, they suggested that 
covering these treatments outside of the hospice benefit may help 
eliminate this burden.
    Should there be separate payments for different types of higher-
cost palliative treatments or one standard payment for any higher-cost 
treatment that would exceed the per-diem rate?
    Comment: A few commenters stated that making blanket inclusions of 
therapies in all situations would not align with the hospice philosophy 
and recommended separate payments for different treatments. Other 
commenters noted the costs of these treatments vary greatly, and 
separate payments would be necessary to adequately account for this 
variation. Commenters stated that separate payments would ensure that 
hospices have adequate financial resources to provide a range of 
higher-cost treatments as needed. They stated each treatment should be 
reimbursed at a predetermined rate, reflecting its value and cost-
effectiveness and separate from the standard per diem payment for 
hospice care. Multiple commenters recommended using Medicare allowable 
rates and existing CPT or HCPCS codes sets. Other recommendations 
included individual billing modifiers that could be used when these 
treatments are furnished to a hospice patient for

[[Page 64237]]

palliative purposes. Commenters also noted that a single rate to cover 
all high-cost treatments would inevitably pay too much for some and not 
enough for others.
    We received several comments in support of a single per diem rate 
for all high-cost treatments. Commenters stated that one standard 
payment for any higher-cost treatment would be in alignment with the 
structure of the per diem rate provided by hospice for standard care 
and reduce confusion. Other commenters noted that having separate 
payments for different types of higher-cost palliative treatments could 
lead to a particular therapy being inadvertently left out of the higher 
cost structure and managing separate payments could increase 
administrative complexity to the claim-submission process.
    A few commenters stated either option would work as long as it 
alleviates the concerns of the financial impact of these high-cost 
treatments and other commenters recommended simply increasing 
reimbursement overall to encompass the costs of high-intensity 
treatments. A few commenters recommended starting with a single payment 
for a period of time while CMS engages in a robust cost analysis to 
develop the most appropriate payment mechanism. And finally, many 
commenters stated CMS should not have separate payments nor a single 
payment, and instead cover these treatments separately from the 
existing hospice benefit. Commenters again recommended concurrent care 
and suggested carving out these palliative treatments under Medicare 
Part B.
    Response: We thank the commenters for their insight and thoughtful 
recommendations. We are incredibly appreciative of the time and effort 
readers put forth in collaborating with CMS as we explore ways to 
improve coverage under the Medicare hospice benefit. We will consider 
all comments and recommendations received on this rule and will 
continue to welcome thoughts regarding these issues through our hospice 
policy mailbox at <a href="/cdn-cgi/l/email-protection#87efe8f4f7eee4e2f7e8ebeee4fec7e4eaf4a9efeff4a9e0e8f1"><span class="__cf_email__" data-cfemail="ef87809c9f868c8a9f8083868c96af8c829cc187879cc1888099">[email&#160;protected]</span></a>. We also remind readers 
they can report suspected fraud, waste, or abuse to CMS. Further 
information on reporting fraud can be found in The Medicare & You 
handbook at page 105 and at <a href="https://www.cms.gov/medicare/medicaid-coordination/center-program-integrity/reporting-fraud">https://www.cms.gov/medicare/medicaid-coordination/center-program-integrity/reporting-fraud</a>. Readers can also 
report suspected fraud, waste, and abuse to the Office of Inspector 
General at <a href="https://oig.hhs.gov/fraud/report-fraud/">https://oig.hhs.gov/fraud/report-fraud/</a>.

D. Proposals to the Hospice Quality Reporting Program (HQRP)

1. Background and Statutory Authority
    The Hospice Quality Reporting Program (HQRP) specifies reporting 
requirements for the Hospice Item Set (HIS), administrative data, and 
Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) 
Hospice Survey. Section 1814(i)(5) of the Act requires the Secretary to 
establish and maintain a quality reporting program for hospices, and 
requires, beginning with FY 2014, that the Secretary reduce the market 
basket update by 2 percentage points for those hospices failing to meet 
quality reporting requirements. Section 1814(i)(5)(A)(i) of the Act was 
amended by section 407(b) of Division CC, Title IV of the CAA, 2021 to 
change the payment reduction for failing to meet hospice quality 
reporting requirements from 2 to 4 percentage points beginning in FY 
2024 for any hospice that does not comply with the quality data 
submission requirements for that FY. In the FY 2024 Hospice final rule, 
we codified the application of the 4-percentage point payment reduction 
for failing to meet hospice quality reporting requirements and set 
completeness thresholds at Sec.  418.312(j).
    Depending on the amount of the annual update for a particular year, 
a reduction of 4 percentage points beginning in FY 2024 could result in 
the annual market basket update being less than zero percent for a FY 
and may result in payment rates that are less than payment rates for 
the preceding FY. Any reduction based on failure to comply with the 
reporting requirements, as required by section 1814(i)(5)(B) of the 
Act, would apply only for the specified year. Typically, about 18 
percent of Medicare-certified hospices are found non-compliant with the 
HQRP reporting requirements annually and are subject to the APU payment 
reduction for a given FY.
    In the FY 2014 Hospice Wage Index and Payment Rate Update final 
rule (78 FR 48234, 48257 through 48262), and in compliance with section 
1814(i)(5)(C) of the Act, we finalized a new standardized patient-level 
data collection vehicle called the Hospice Item Set (HIS). We also 
finalized the specific collection of data items that support eight 
consensus-based entity (CBE)-endorsed measures for hospice.
    In the FY 2015 Hospice Wage Index and Payment Rate Update final 
rule (79 FR 50452), we finalized national implementation of the 
CAHPS[supreg] Hospice Survey, a component of the CMS HQRP which is used 
to collect data on the experiences of hospice patients and the primary 
caregivers listed in their hospice records. Readers who want more 
information about the development of the survey, originally called the 
Hospice Experience of Care Survey, may refer to the FY 2014 and FY 2015 
Hospice Wage Index and Payment Update final rules (78 FR 48261 and 79 
FR 50452, respectively). National implementation commenced January 1, 
2015. We adopted eight CAHPS[supreg] survey-based measures for the CY 
2018 data collection period and for subsequent years. These eight 
measures are publicly reported on the Care Compare website.
    In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 
47142, 47186 through 47188), we finalized the policy for retention of 
HQRP measures adopted for previous payment determinations and seven 
factors for removal. In that same final rule, we discussed how we would 
provide public notice through rulemaking of measures under 
consideration for removal, suspension, or replacement. We also stated 
that if we had reason to believe continued collection of a measure 
raised potential safety concerns, we would take immediate action to 
remove the measure from the HQRP and not wait for the annual rulemaking 
cycle. The measures would be promptly removed and we would immediately 
notify hospices and the public of such a decision through the usual 
HQRP communication channels, including but not limited to listening 
sessions, email notifications, Open Door Forums, and Web postings. In 
such instances, the removal of a measure will be formally announced in 
the next annual rulemaking cycle.
    On August 31, 2020, we added correcting language to the FY 2016 
Hospice Wage Index and Payment Rate Update and Hospice Quality 
Reporting Requirements; Correcting Amendment (85 FR 53679) hereafter 
referred to as the FY 2021 HQRP Correcting Amendment. In this final 
rule, we made correcting amendments to 42 CFR 418.312 to correct 
technical errors identified in the FY 2016 Hospice Wage Index and 
Payment Rate Update final rule. Specifically, the FY 2021 HQRP 
Correcting Amendment (85 FR 53679) adds paragraph (i) to Sec.  418.312 
to reflect our exemptions and extensions requirements, which were 
referenced in the preamble but inadvertently omitted from the 
regulations text. Thus, these exemptions or extensions can occur when a 
hospice encounters certain extraordinary circumstances.
    In the FY 2017 Hospice Wage Index and Payment Rate Update final 
rule, we

[[Page 64238]]

finalized the ``Hospice Visits When Death is Imminent'' measure pair 
(HVWDII, Measure 1 and Measure 2), effective April 1, 2017. We refer 
the public to the FY 2017 Hospice Wage Index and Payment Rate Update 
final rule (81 FR 52144, 52163 through 52169) for a detailed 
discussion.
    As stated in the FY 2019 Hospice Wage Index and Rate Update final 
rule (83 FR 38622, 38635 through 38648), we launched the ``Meaningful 
Measures Initiative'' (which identifies high priority areas for quality 
measurement and improvement) to improve outcomes for patients, their 
families, and providers while also reducing burden on clinicians and 
providers. The Meaningful Measures Initiative is not intended to 
replace any existing CMS quality reporting programs, but will help such 
programs identify and select individual measures. The Meaningful 
Measure Initiative areas are intended to increase measure alignment 
across our quality programs and other public and private initiatives. 
Additionally, it will point to high priority areas where there may be 
gaps in available quality measures while helping to guide our efforts 
to develop and implement quality measures to fill those gaps. More 
information about the Meaningful Measures Initiative can be found at: 
<a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html</a>.
    In the FY 2022 Hospice Wage Index and Payment Rate Update final 
rule (86 FR 42552), we finalized two new measures using claims data: 
(1) Hospice Visits in the Last Days of Life (HVLDL); and (2) Hospice 
Care Index (HCI). We also removed the Hospice Visits when Death is 
Imminent (HVWDII) measure, as it was replaced by HVLDL. We also 
finalized a policy that claims-based measures would use 8 quarters of 
data to publicly report on more hospices.
    In addition, we removed the seven Hospice Item Set (HIS) Process 
Measures from the program as individual measures, and ceased their 
public reporting because, in our view, the HIS Comprehensive Assessment 
Measure is sufficient for measuring care at admission without the seven 
individual process measures. In the FY 2022 Hospice Wage Index and Rate 
Update final rule (86 FR 42553), we finalized Sec.  418.312(b)(2), 
which requires hospices to provide administrative data, including 
claims-based measures, as part of the HQRP requirements for Sec.  
418.306(b). In that same final rule, we provided CAHPS Hospice Survey 
updates.
    As finalized in the FY 2022 Hospice Wage Index and Payment Rate 
Update final rule (86 FR 42552), public data reflecting hospices' 
reporting of the two new claims-based quality measures (QMs), the 
``Hospice Visits in Last Days of Life'' (HVLDL) and the ``Hospice Care 
Index'' (HCI) measures, are available on the Care Compare/Provider Data 
Catalogue (PDC) web pages as of the August 2022 refresh. In the FY 2023 
and FY 2024 Hospice Wage Index final rules, we did not propose any new 
quality measures. However, we provided updates on already-adopted 
measures. Table 13 shows the current quality measures in effect for the 
FY 2025 HQRP, which were finalized in the FY 2022 Hospice Wage Index 
and Payment Rate Update final rule and have been carried over in each 
subsequent year.

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[GRAPHIC] [TIFF OMITTED] TR06AU24.071

2. Implementation of Two Process Quality Measures Based on Proposed 
HOPE Data Collection
    Section 1814(i)(5) of the Act requires the Secretary to establish 
and maintain a quality reporting program for hospices, develop and 
implement quality measures, and publicly report quality measures. In 
this final rule, we are finalizing the addition of two process measures 
no sooner than FY 2028 to the HQRP calculated from data collected from 
HOPE: Timely Follow-Up for Pain Impact and Timely Follow-Up for Non-
Pain Symptom Impact. We will use the data collected from HOPE (see 
section III.D.3 on the proposal to implement HOPE and associated PRA), 
which a nurse would assess at multiple time points during a hospice 
stay to collect data related to patients' symptoms during those 
assessments. These two measures will determine whether a follow-up 
visit occurs within two (2) days of an initial assessment of moderate 
or severe symptom impact.
    Symptom alleviation is an important aspect of hospice care, 
including both pain management and non-pain symptom management. CMS has 
heard this feedback consistently from both clinicians and caregivers, 
including the Technical Expert Panel (TEP) which CMS convened from 2019 
through 2023. At present, HQRP only has a component of a measure 
indicating whether the pain symptom was assessed, as a part of the 
comprehensive assessment at admission measure. This measure alone does 
not adequately measure whether hospices are alleviating hospice 
patients' symptoms throughout their hospice stay.
    CMS considers symptom management an important domain to address 
further via the HQRP program. Therefore, we will implement these new 
concepts on

[[Page 64240]]

timely follow-up of symptoms with the support and input of hospice 
experts. For cases where a patient is assessed as having high (that is, 
more severe) symptom impact, practitioners suggest that good care 
processes include trying to follow-up with the patient and having in-
person visits within two (2) days to ensure treatment has helped 
alleviate and/or manage those symptoms. Therefore, we are finalizing 
two process measures derived from HOPE data--Timely Follow-Up for Pain 
Impact and Timely Follow-Up for Non-Pain Symptom Impact--will capture 
these care processes.
    Our paramount concern is the successful development of an HQRP that 
promotes the delivery of high-quality healthcare services. We seek to 
adopt measures for the HQRP that promote efficient, safer, and patient-
centered care. Our measure selection activities for the HQRP take into 
consideration input we receive from the CBE, as part of a pre-
rulemaking process that we have established and are required to follow 
under section 1890A of the Act. The CBE convenes interested parties 
from multiple groups to provide CMS with recommendations on the 
Measures Under Consideration (MUC) list. This input informs how CMS 
selects certain categories of quality and efficiency measures as 
required by section 1890A(a)(3) of the Act. By February 1st of each 
year, the CBE must provide that input to CMS. For more details about 
the pre-rulemaking process, please visit the Partnership for Quality 
Measurement website at <a href="https://p4qm.org/PRMR">https://p4qm.org/PRMR</a>.
    We also consider national priorities, such as those established by 
the Partnership for Quality Measurement, the HHS Strategic Plan, and 
the National Strategy for Quality Improvement in Healthcare located at 
<a href="https://www.cms.gov/cciio/resources/forms-reports-and-other-resources/quality03212011a">https://www.cms.gov/cciio/resources/forms-reports-and-other-resources/quality03212011a</a>. To the extent possible, we have sought to adopt 
measures that have been endorsed by the national CBE, recommended by 
multiple organizations of interested parties, and developed with the 
input of providers, payers, and other relevant stakeholders.
a. Measure Importance
    The FY 2019 Hospice Wage Index final rule (83 FR 38622) introduced 
the Meaningful Measure Initiative to hospice providers to identify high 
priority areas for quality measurement and improvement. The Meaningful 
Measure Initiative areas are intended to increase measure alignment 
across programs and other public and private initiatives. Additionally, 
the Initiative points to high priority areas where there may be 
informational gaps in available quality measures. The Initiative helps 
guide our efforts to develop and implement quality measures to fill 
those gaps and develop those concepts towards quality measures that 
meet the standards for public reporting. The goal of HQRP quality 
measure development is to identify measures from a variety of data 
sources that provide a window into hospice care services throughout the 
dying process, fit well with the hospice business model, and meet the 
objectives of the Meaningful Measures Initiative.
    To that end, the Timely Follow-Up for Pain Impact and Timely 
Follow-Up for Non-Pain Symptom Impact measures will add value to HQRP 
by filling an identified informational gap in the current measure set. 
Specifically, the Timely Follow-Up for Pain Impact process measure will 
determine how many patients assessed with moderate or severe pain 
impact were reassessed by the hospice within 2-calendar days, and the 
Timely Follow-Up for Non-Pain Symptom Impact process measure will 
determine how many patients assessed with moderate or severe non-pain 
impact were reassessed by the hospice within 2-calendar days. Compared 
to the single existing HQRP measure that includes pain symptom 
assessment, the two HOPE-based process measures will better reflect 
hospices' efforts to alleviate patients' symptoms on an ongoing basis.
b. Specifications of the Measures
    We are finalizing that both the process measures based on HOPE data 
will be calculated using assessments collected at admission or the HOPE 
Update Visit (HUV) timepoints. Pain symptom severity and impact will be 
determined based on hospice patients' responses to the pain symptom 
impact data elements within HOPE. Non-pain symptom severity and impact 
will be determined based on patients' responses to the HOPE data 
elements related to shortness of breath, anxiety, nausea, vomiting, 
diarrhea, constipation, and agitation. Additional information regarding 
these data items and time points can be found in the draft HOPE 
Guidance Manual of the HOPE web page at <a href="https://www.cms.gov/medicare/quality/hospice/hope">https://www.cms.gov/medicare/quality/hospice/hope</a> and the PRA package that accompanies this Rule can 
be accessed at <a href="https://www.cms.gov/medicare/regulations-guidance/legislation/paperwork-reduction-act-1995/pra-listing">https://www.cms.gov/medicare/regulations-guidance/legislation/paperwork-reduction-act-1995/pra-listing</a>. We finalize the 
proposal that only in-person visits will count for the collection of 
data for these proposed measures--that is, telehealth calls will not 
count for a follow-up. We sought comment on whether only in-person 
visits are appropriate for collection of data for these proposed 
measures or if other types of visits, such as telehealth, should be 
included. We are finalizing the decision that a follow-up visit cannot 
be the same visit as the initial assessment, but it can occur later in 
the same day (as a separate visit).
    However, we recognize that requiring in-person visits may impact 
existing staffing shortages faced by many hospice providers. CMS 
maintains to avoid creating unnecessary burden for hospice providers. 
Therefore, to minimize the burdensome impact of the in-person staffing 
requirement and to take advantage of the staff members hospices have, 
we are finalizing a decision that symptom follow-up visits (SFVs), 
referred to in the proposed rule as the Symptom Reassessment, may be 
performed by either RNs or Licensed Practical Nurses (LPNs)/Licensed 
Vocational Nurses (LVNs).
    For both the Timely Follow-Up for Pain Impact and Timely Follow-Up 
for Non-Pain Symptom Impact measures, beneficiaries will be included in 
the denominator if they have a moderate or severe level of pain or non-
pain symptom impact, respectively, at their initial assessment. 
However, certain exclusions will apply to these denominators, such as 
beneficiaries who die or are discharged alive before the two-day 
window, if the patient/caregiver refused the follow-up visit, the 
hospice was unable to contact the patient/caregiver to perform the 
follow-up, the patient traveled outside the service area, or the 
patient was in the ER/hospital during the two-day follow-up window. In 
these situations, a hospice will be unable to conduct a follow-up due 
to circumstances beyond their control, and therefore these situations 
will not be included in the measure denominator.
    The numerators for these measures will reflect beneficiaries who 
did receive a timely symptom follow-up. These will include 
beneficiaries who receive a separate HOPE follow-up within 2-calendar 
days of the initial assessment (for example, if a pain has moderate or 
severe symptoms assessed on Sunday, the hospice would be expected to 
complete the follow-up on or before Tuesday).
c. Measure Reportability, Variability, and Validity
    As part of developing these quality measures, CMS and their measure 
development contractor conducted simulations of measure reportability 
rates and measure variability. We used

[[Page 64241]]

the results of the HOPE Beta Test to estimate HOPE data availability 
for a national population of hospice patients. Detailed information 
regarding reportability and variability testing is provided in the HOPE 
Beta Testing Report, available on the HOPE web page at <a href="https://www.cms.gov/medicare/quality/hospice/hope">https://www.cms.gov/medicare/quality/hospice/hope</a>. Additionally, CMS assessed 
each proposed quality measure face validity with input from TEP members 
convened in March 2023. Further information about our validity analysis 
is provided in the 2022-2023 HQRP TEP Report, available in the 
Downloads section of the HQRP Provider and Stakeholder Engagement page. 
Our reportability and variability analyses did not present concerns for 
the proposed HOPE-based process measures, and our validity analysis 
indicated that the proposed measures have high face validity.
d. Future Plans for Testing HOPE-Based Quality Measures
    Testing of the two process quality measures has thus far relied on 
data from the HOPE beta (field) test. We proposed future measure 
testing to be conducted using a full sample of hospices collected after 
HOPE has been implemented nationally, to support further development of 
quality measures.
e. Public Engagement and Support
    CMS engaged the public in multiple stages of HOPE-based measure 
development. To support measure development, CMS convened multiple 
technical expert panel (TEP) meetings which served as information 
gathering activities, consistent with the Meaningful Measure 
Initiative. The TEP consisted of experts in hospice and clinical 
quality measurement, and it has contributed to development of the HOPE 
tool and measure concepts since 2019. Based on early TEP input about 
measure prioritization, measure concept development focused on pain and 
non-pain symptoms. TEP members noted the importance of measuring the 
quality of pain and symptom management, as this is a key role of 
hospice. Through 2020 and 2021, the TEP provided further feedback on 
pain and non-pain symptom measure specifications. In Spring 2023, CMS 
convened the TEP a final time to review the final measure 
specifications, HOPE Beta test results, and rate face validity of the 
measure score. The TEP gave strong support for the proposed measure 
specifications, rated high face validity for these two process 
measures, and noted the importance of measuring the quality of pain 
management in hospice care. More information about the TEP meetings and 
recommendations can be found in the HQRP TEP Reports for 2019-2023, 
available on the Provider and Stakeholder Engagement web page. CMS also 
sought hospice provider input during the HOPE Beta Test to further 
inform the development of these HOPE-based process measures. During 
beta testing, registered nurses (RNs) reported that the two-day window 
of HOPE symptom follow-up aligned with their usual practices.
f. Update on Future Quality Measure (QM) Development
    As stated in the FY 2022 Hospice Wage Index final rule (86 FR 
42528), we continue to consider developing hybrid quality measures that 
could be calculated from multiple data sources, such as claims, HOPE 
data, or other data sources (for example, CAHPS Hospice Survey). To 
support new measure development, our contractor convened technical 
expert panel (TEP) meetings in 2022 and 2023. The TEP agreed that CMS 
should consider applying several risk adjustment factors, such as age 
and diagnosis, to ensure comparable, representative comparisons between 
hospices. The TEP also suggested using length of hospice stay but not 
functional status as risk adjustment factor for hospice performance.
    To support new HOPE-based measure development, our contractor 
convened technical expert panel (TEP) meetings between 2020 and 2023. 
The TEP recommended specifications for the two HOPE-based quality 
measures proposed in this Rule--Timely Follow-Up for Pain Impact and 
Timely Follow-Up for Non-Pain Symptom Impact. CMS also sought TEP input 
on several measurement concepts proposed for future quality measure 
development. Of these measurement concepts, the TEP supported CMS 
further developing the Education for Medication Management and Wound 
Management Addressed in Plan of Care process concepts. More information 
about the TEP recommendations can be found in the 2023 HQRP TEP Report, 
available on the Provider and Stakeholder Engagement web page. CMS will 
take the TEP's recommendations under consideration as we continue to 
develop HOPE-based quality measures.
    Additional information about CMS's HOPE-based measure development 
efforts is available in the 2022-2023 HQRP TEP Summary Report (<a href="https://www.cms.gov/files/document/2023-hqrp-tep-summary-report.pdf">https://www.cms.gov/files/document/2023-hqrp-tep-summary-report.pdf</a> and the 
2023 Information Gathering Report, available on the HQRP Provider and 
Stakeholder Engagement web page, or at <a href="https://www.cms.gov/files/document/hospicequalityreportingprograminformationgatheringreport2023508.pdf">https://www.cms.gov/files/document/hospicequalityreportingprograminformationgatheringreport2023508.pdf</a>. 
For further details about the ongoing development of these measures, 
please visit the Partnership for Quality Measurement website: <a href="https://p4qm.org/">https://p4qm.org/</a>.
    Comment: We received 13 public comments regarding the two HOPE-
based process measures. Public comments generally supported the 
addition of the two proposed HOPE-based QMs.
    Several commenters suggested modifications to the measures. One 
commenter suggested that CMS discontinue the collection of some HIS 
measures rather than combining them into the HOPE tool. One commenter 
suggested that CMS standardize the definitions of slight, moderate, and 
severe symptom impact to improve the reliability of QM data. One 
commenter requested guidance regarding how hospices should categorize 
patients whose symptom impact has lessened or stabilized at the time of 
the follow-up visit. Another commenter suggested that CMS calculate the 
measures both with and without patients who refused to visit to 
determine whether visit refusals correlate with other quality concerns.
    One commenter requested clarification regarding penalties to 
hospices for patients who decline a symptom follow-up visit. One 
comment requested clarification about the start date of HOPE QM public 
reporting and whether the start date would be based on the Fiscal Year 
(FY) or the Calendar Year (CY). One commenter requested clarification 
regarding penalties to hospices for patients who decline a symptom 
follow-up visit. Another commenter requested that CMS provide data 
regarding the proportion of QRP compliant agencies nationally, efforts 
to improve hospices' ability to report data to CMS, and efforts to 
enhance transparency to the public. Several commenters requested that 
CMS delay public reporting of the HOPE-based QMs until 2028 to ensure 
adequate time for hospices and EMR vendors to implement the measures, 
as well as sufficient time to collect data and issue provider preview 
reports.
    Some commenters expressed concerns about the new QMs. One comment 
recommended the measures be further developed before implementation, 
citing the lack of CBE endorsement. Several comments encouraged CMS to 
next focus on developing HOPE-based outcome measures, which would add 
further value to HQRP.
    Response: CMS appreciates all public comments regarding the new 
HOPE-

[[Page 64242]]

based process QMs. We understand that there are several tools to 
measure the severity of these symptoms. However, the items for Symptom 
Impact are not measuring symptom intensity or severity, but rather the 
impact the patient is experiencing. The Symptom Impact data elements 
were adapted from an Integrated Palliative Outcome Scale (IPOS) data 
element that asked about the effect of symptoms on the patient. Please 
refer to the HOPE development and Testing Report posted on the HOPE web 
page for more details: <a href="https://www.cms.gov/files/document/hqrp-hospice-outcomes-and-patient-evaluation-hope-development-and-testing-report.pdf">https://www.cms.gov/files/document/hqrp-hospice-outcomes-and-patient-evaluation-hope-development-and-testing-report.pdf</a>. We will continue to provide guidance on this measure, which 
will be informed by commenters questions and concerns.
    CMS is committed to providing hospice providers and vendors with 
adequate time to implement the new HOPE-based QMs, and intends to 
support hospices during the transition period. In this final rule, we 
clarified the timeframes for anticipated public reporting. Additional 
guidance regarding the new HOPE-based measures will be provided through 
education and training materials and events leading up to the public 
reporting of the measures. CMS also intends to continue working with 
the CBE to ensure that these and future quality measures meaningfully 
measure the quality of hospice care and help patients, families, and 
caregivers to make important hospice decisions.
    Comments: We received 15 public comments regarding the time points 
and burden of the two HOPE-based measures.
    Several commenters sought clarification on the number of symptom 
follow-up visits required and whether the symptom follow-up is allowed 
at the admission or HUV timepoints. One comment suggested that symptom 
follow-up should be considered an additional timepoint if it may not be 
completed during another timepoint.
    Several commenters requested that CMS clarify whether the time 
frame for symptom follow-up will be 48 hours or 2-calendar days. One 
commenter requested that CMS extend the time frame for follow-up 
visits. Another commenter appreciated CMS' decision that the symptom 
follow-up visit cannot be the same as the initial assessment visit, 
although it can occur in the same day.
    Several commenters expressed concerns about the anticipated burden 
the new measures will add to hospices. Many commenters requested that 
we allow telehealth or phone visits for symptom follow-up. Two 
commenters recommended that patients' preference for and tolerance of 
pain be included in the measures. Two commenters requested that LPNs be 
allowed to reassess patients' symptom impact. One commenter requested 
that occupational therapists be included as members of the hospice 
interdisciplinary team for purposes of the new QMs. One comment 
suggested that any hospice team member should be allowed to complete 
the symptom follow-up visit, whether clinical or administrative.
    Many comments expressed concern that the symptom follow-up visits 
(SFV) would create undue burden unless they can be completed via 
telehealth or phone visits. Two comments highlighted staffing 
challenges, and several other comments anticipated burdensome costs due 
to staff training, EMR management, monitoring and oversight, and/or the 
increased number of patient visits. One commenter raised concerns that 
the measures would disproportionately burden rural hospices.
    Response: CMS appreciates all comments regarding the new HOPE-based 
process QMs and their corresponding time points.
    At this time, CMS does not believe the symptom follow-up should be 
considered a unique HOPE time point. Commenters seeking additional 
guidance regarding the symptom follow-up visits should refer to the 
HOPE v1.0 Guidance Manual (page 8 and 9), which states that ``Depending 
upon responses to J2051. Symptom Impact, at Admission and the two HUV 
timepoints, up to three symptom follow-up visits may be required over 
the course of the hospice stay.'' The Guidance Manual further states 
that ``Although multiple symptom follow-up visits are not required for 
the purpose of the HQRP, it is expected that the hospice staff will 
continue to follow up with the patient, based on their clinical and 
symptom management needs.''
    We acknowledge the commenters' recommendation that more hospice 
team members should be allowed to complete the symptom follow-up visit. 
Therefore, in this final rule, we have decided that both RNs and LPNs/
LVNs may complete the symptom follow-up. At this time, CMS believes it 
is most appropriate for clinical staff to complete symptom assessments 
and follow-up visits.
    While we understand commenters' concerns about the potential 
staffing burdens of in-person visits, CMS selected this requirement 
based on expert input regarding hospice best practices. However, to 
minimize the burdensome impact of the in-person staffing requirement 
and to take advantage of the staff members hospices have, we are 
finalizing a decision that symptom follow-up visits (SFVs) may be 
performed by either RNs or LPNs/LVNs. We will continue to monitor the 
provision and burden of in-person HOPE follow-up visits after HOPE 
implementation and evaluate whether revisions to the HOPE 
administration requirements are necessary. If modifications to the HOPE 
instrument are required, they will be proposed in future rulemaking.
    Commenters seeking additional guidance regarding the symptom 
follow-up visits should refer to the HOPE v1.0 Guidance Manual (page 8 
and 9), which states that ``Depending upon responses to J2051. Symptom 
Impact, at Admission and the two HUV timepoints, up to three symptom 
follow-up visits may be required over the course of the hospice stay.'' 
The Guidance Manual further states that ``Although multiple symptom 
follow-up visits are not required for the purpose of the HQRP, it is 
expected that the hospice staff will continue to follow up with the 
patient, based on their clinical and symptom management needs.''
    CMS is committed to providing hospice providers and vendors with 
adequate time to implement the new HOPE-based QMs, and intends to 
support hospice stakeholders during the transition period. In this 
final rule, CMS has clarified the time frames for the HOPE-based QMs 
and anticipated public reporting. Additional guidance regarding the new 
HOPE-based measures will be provided through education and training 
materials and events leading up to the public reporting of the 
measures, anticipated to occur no earlier than November 2027 (FY 2028). 
CMS also intends to continue working with CBEs to ensure that these and 
future quality measures meaningfully measure the quality of hospice 
care and help patients, families, and caregivers to make important 
hospice decisions.
    After considering the public feedback received on the FY 2025 
Hospice proposed rule we are finalizing the measures with modifications 
from the version proposed in the proposed rule. As finalized, theses 
QMs measure

[…truncated; see source link]
Indexed from Federal Register on August 6, 2024.

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