[Federal Register Volume 89, Number 66 (Thursday, April 4, 2024)]
[Proposed Rules]
[Pages 23778-23838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06921]
[[Page 23777]]
Vol. 89
Thursday,
No. 66
April 4, 2024
Part III
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; Proposed Rule
Federal Register / Vol. 89 , No. 66 / Thursday, April 4, 2024 /
Proposed Rules
[[Page 23778]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 418
[CMS-1810-P]
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: Proposed rule.
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SUMMARY: This proposed rule would update the hospice wage index,
payment rates, and aggregate cap amount for Fiscal Year (FY) 2025. This
rule proposes changes to the Hospice Quality Reporting Program. This
rule also proposes to adopt the most recent Office of Management and
Budget statistical area delineations, which would change the hospice
wage index. This rule proposes to clarify current policy related to the
``election statement'' and the ``notice of election'', as well as to
add clarifying language regarding hospice certification. Finally, this
rulemaking solicits comments regarding potential implementation of a
separate payment mechanism to account for high intensity palliative
care services.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than May 28, 2024.
ADDRESSES: In commenting, refer to file code CMS-1810-P.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1810-P, P.O. Box 8010,
Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1810-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
For general questions about hospice payment policy, send your
inquiry via email to: [email protected].
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:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a
plain language summary of this proposed rule may be found at https://www.regulations.gov/.
I. Executive Summary
A. Purpose
This proposed rule would update 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 proposes to adopt the most recent Office of
Management and Budget (OMB) statistical area delineations based on data
collected during the 2020 Decennial Census, which would result in
changes to the hospice wage index. In addition, this rule proposes
reorganization of the regulations to clarify current policy related to
the ``election statement'' and the ``notice of election (NOE),'' as
well as to add clarifying language regarding who can certify terminal
illness. This rulemaking solicits comments on a potential policy to
account for the increased hospice costs of providing high intensity
palliative care services. In past rules, we have presented data
regarding important hospice utilization trends. This year, and in
subsequent years, the monitoring section will be removed from the
rulemaking and placed on the CMS hospice center web page, which can be
found at https://www.cms.gov/medicare/payment/fee-for-service-providers/hospice.
This rule also proposes that Hospice Quality Reporting Program
(HQRP) measures be collected through a new collection instrument, the
Hospice Outcomes and Patient Evaluation (HOPE); this rule also proposes
two HOPE-based measures and lays out the planned trajectory for further
development of this instrument; requests information regarding
potential social determinants of health (SDOH) elements and provides
updates on Health Equity, future quality measures (QMs), and public
reporting requirements. Finally, this rule also proposes 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 proposed rule proposes updates to 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 proposed rule proposes to adopt 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 proposed rule includes the proposed FY 2025
hospice payment update percentage of 2.6 percent.
Section III.A.4 of this proposed rule proposes updates to the
hospice payment rates.
Section III.A.5 of this proposed rule includes the proposed update
to the hospice cap amount for FY 2025 by the hospice payment update
percentage of 2.6 percent.
In section III.B of this proposed rule, we propose clarifying
regulation text changes, with no change to current policy. This
includes reorganizing the regulations to clearly identify the
distinction between the ``election
[[Page 23779]]
statement'' and the ``notice of election,'' as well as including
clarifying text changes that align payment regulations and Conditions
of Participation (CoPs) regarding who may certify terminal illness and
determine admission to hospice care.
In section III.C of this proposed rule, we include a Request for
Information (RFI) 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 rule proposed rule, we propose
HOPE-based process measures; the HOPE instrument; discuss updates to
potential future quality measures; and propose changes to the
CAHPS[supreg] Hospice Survey.
C. Summary of Impacts
The overall economic impact of this proposed rule is estimated to
be $705 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 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 his or her 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 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, 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 to their home and continue to receive 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 proposed rule must comply with applicable
civil rights laws, including section 1557 of the Affordable Care Act,
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 for effective
communication.\1\ Further information may be found at: https://www.hhs.gov/civil-rights/index.html.
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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 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
92.101(a)). Meaningful access may require the provision of interpreter
services and translated materials (45 CFR 92.101(a)(2)).
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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 FR
47311 (Aug. 8, 2003), https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/guidance-federal-financial-assistance-recipients-title-vi/index.html.
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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-
[[Page 23780]]
language pathology therapy; medical social services; home health aide
services (called hospice aide services); physician services; homemaker
services; medical supplies (including drugs and biologicals); 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 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.\3\
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\3\ Hospice Regulations and Notices. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Regulations-and-Notices.
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III. Provisions of the Proposed Rule
A. Proposed FY 2025 Hospice Wage Index and Rate Update
1. Proposed 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 Metropolitan Statistical Areas (MSAs), Micropolitan
Statistical Areas, and Combined Statistical Areas, and guidance on uses
of the delineations in these areas. This bulletin provided the
delineations of all MSAs, Metropolitan Divisions, Micropolitan
Statistical Areas, Combined Statistical Areas, 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: https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf. 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: https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf.) In OMB Bulletin No. 20-01,
OMB announced one new Micropolitan Statistical Area, one new component
of an existing Combined Statistical Area
[[Page 23781]]
(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 0.8 will be further adjusted by a 15 percent
increase subject to a maximum wage index value of 0.8. 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 0.8, 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
0.8, County B's hospice wage index would be 0.8.
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 above. 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 from above, 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, 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., if we adopt the revised OMB delineations this methodology
would 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 are
proposing that the proposed 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). The proposed FY 2025
hospice wage index would not take into account any geographic
reclassification of hospitals, including those in accordance with
section 1886(d)(8)(B) or 1886(d)(10) of the Act. 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 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, skilled nursing
facility prospective payment system (SNF PPS), inpatient rehabilitation
facility prospective payment system (IRF PPS), and 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 0.8 by a 15 percent increase subject
to a maximum wage index value of 0.8. The proposed 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.
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 of
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
[[Page 23782]]
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 proposed wage index value for Hinesville-Fort
Stewart, Georgia is 0.8726.
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, we are proposing that rural North Dakota
would now become a rural area without a hospital from which hospital
wage data can be devised. Therefore, to calculate the wage index for
rural area 99935, North Dakota, we are proposing to use as a proxy, the
average pre-floor, pre-reclassified hospital wage data (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 results in a proposed FY 2025 hospice wage index of
0.8446 for rural North Dakota.
[GRAPHIC] [TIFF OMITTED] TP04AP24.003
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, as part of our
proposal to adopt the revised OMB delineations discussed further in
section III.A.2.c. below, there would now be a hospital in rural Puerto
Rico from which hospital wage data can be derived. Therefore, we are
proposing that the wage index for rural Puerto Rico would now be based
on the hospital wage data for the area instead of the previously
available 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 results in a proposed wage index of 0.4421.
Finally, we are proposing that for FY 2025, if the adoption of the
revised OMB delineations is finalized 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. The proposed FY
2025 wage index for rural area 99908 Delaware would be 1.0429.
2. Proposed Implementation of New Labor Market Delineations
On July 21, 2023, OMB issued Bulletin No. 23-01, which updates and
supersedes OMB Bulletin No. 20-01, issued on March 6, 2020. OMB
Bulletin No. 23-01 establishes revised delineations for the MSAs,
Micropolitan Statistical Areas, Combined Statistical Areas, and
Metropolitan Divisions, collectively referred to as Core Based
Statistical Areas (CBSAs). According to OMB, the delineations reflect
the 2020 Standards for Delineating Core Based Statistical Areas (CBSAs)
(the ``2020 Standards''), which appeared in the Federal Register (86 FR
37770 through 37778) on July 16, 2021, and application of those
standards to Census Bureau population and journey-to-work data (for
example, 2020 Decennial Census, American Community Survey, and Census
Population Estimates Program data). A copy of OMB Bulletin No. 23-01 is
available online at: https://www.whitehouse.gov/wp-content/uploads/2023/07/OMB-Bulletin-23-01.pdf.
The July 21, 2023 OMB Bulletin No. 23-01 contains a number of
significant changes. For example, there are new CBSAs, urban counties
that have become rural, rural counties that have become urban, and
existing CBSAs that have been split apart. We believe it is important
for the hospice wage index to use the latest OMB delineations available
in order to maintain a more accurate and up-to-date payment system that
reflects the reality of population shifts and labor market conditions.
We further believe that using the most current OMB delineations would
increase the integrity of the hospice wage index by creating a more
accurate representation of geographic variation in wage levels. We are
proposing to implement the new OMB delineations as described in the
July 21, 2023 OMB Bulletin No. 23-01 for the hospice wage index
effective beginning in FY 2025.
a. Micropolitan Statistical Areas
As discussed in the FY 2006 Hospice Wage Index and Payment Rate
Update
[[Page 23783]]
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 Inpatient Prospective Payment System (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 became 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 the IPPS, we are also proposing to continue to treat
Micropolitan Areas as ``rural'' and to include Micropolitan Areas in
the calculation of each State's rural wage index.
b. Change to County-Equivalents in the State of Connecticut
In a June 6, 2022 Notice (87 FR 34235-34240), the Census Bureau
announced that it was implementing the State of Connecticut's request
to replace the eight counties in the State with nine new ``Planning
Regions.'' Planning regions are included in OMB Bulletin No. 23-01 and
now serve as county-equivalents within the CBSA system. We have
evaluated the change and are proposing to adopt the planning regions as
county equivalents for wage index purposes. We believe it is necessary
to adopt this migration from counties to planning region county-
equivalents in order to maintain consistency with our established
policy of adopting the most recent OMB updates. We are providing the
following crosswalk in Table 2 for counties located in Connecticut with
the current and proposed FIPS county and county-equivalent codes and
CBSA assignments.
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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 would become rural if we
adopt as final our proposal to implement the revised OMB delineations.
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d. Rural Counties That Would Become Urban
Under the revised OMB statistical area delineations (based upon OMB
Bulletin No. 23-01), a total of 54 counties (and county equivalents)
that are currently located in rural areas would be considered located
in urban areas under the revised OMB delineations beginning in FY 2025.
Table 4 lists the 54 counties that would be urban if we adopt as final
our proposal to implement the revised OMB delineations.
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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 section).
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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.
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In other cases, if we adopt the new OMB delineations, some counties
would shift between existing and new CBSAs, changing the constituent
makeup of the CBSAs. In another type of change, some CBSAs have
counties that would split off to become part of or to form entirely new
labor market areas. For example, the District of Columbia, DC, Charles
County, MD and Prince Georges County, MD would move from CBSA 47894
(Washington-Arlington-Alexandria, DC-VA-MD-WV) into CBSA 47764
(Washington, DC-Md). Calvert County, MD would move from CBSA 47894
(Washington-Arlington-Alexandria, DC-VA-MD-WV) into CBSA 30500
(Lexington Park, MD). The remaining counties that currently make up
47894 (Washington-Arlington-Alexandria, DC-VA-MD-WV) would move into
CBSA 11694 (Arlington-Alexandria-Reston, VA-WV). Finally, in some
cases, a CBSA would lose counties to another existing CBSA if we adopt
the new OMB delineations. For example, Grainger County, TN would move
from CBSA 34100 (Morristown, TN) into CBSA 28940 (Knoxville, TN). Table
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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BILLING CODE 4120-01-C
f. Proposed Transition Period
In the past we have provided for transition periods when adopting
changes that have significant payment implications, particularly large
negative impacts, in order to mitigate the potential impacts of
proposed 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 potential negative impact
caused by our proposed adoption of the revised delineations, we propose
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 are proposing for FY 2025,
that the 5-percent cap would also be applied to counties that would
move from a CBSA or statewide rural area with a higher wage index value
into a new CBSA or rural area with a lower wage index value, so that
the county's 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 propose to calculate the 5-percent cap for
counties that experience an OMB designation change, some CBSAs and
statewide rural areas could have more than one wage index value because
of the potential for their constituent counties to have different wage
index values 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
[[Page 23797]]
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 are proposing that
beginning in FY 2025, counties that have a different wage index value
than the CBSA or rural area into which they are designated after the
application of the 5-percent cap would use a wage index transition
code. These special codes are five digits in length and begin with
``50.'' 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 are proposing that Lamar County would be redesignated
into the Rural Georgia Code 99911. Because the wage index value of
rural Georgia is more than a 5-percent decrease from the wage index
value that Lamar County previously received under CBSA 12060, the 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.
Additionally, we are proposing that the 5-percent cap would apply
to a county that corresponds to a different wage index value than the
wage index value in the CBSA or rural area in which they are designated
due to a delineation change until the county's new wage index is more
than 95 percent of the wage index from the previous fiscal year. We are
also proposing 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 the 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 above, 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 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.
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BILLING CODE 4120-01-C
The proposed wage index applicable to FY 2025 provides a crosswalk
between the FY 2025 wage index using the current OMB delineations and
the FY 2025 wage index using the proposed revised OMB delineations that
would be in effect in FY 2025 if these proposed changes are finalized.
This file shows each State and county and its corresponding proposed
wage index along with the previous CBSA number, the proposed CBSA
number or alternate identification number, and the proposed CBSA name.
The proposed hospice wage index file applicable for FY 2025 (October 1,
2024 through September 30, 2025) is available on the CMS website at:
https://www.cms.gov/medicare/payment/fee-for-service-providers/hospice/hospice-regulations-and-notices.
3. Proposed 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 according to 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 http://www.bls.gov for the BLS historical published TFP data. A complete
description of IGI's TFP projection methodology is available on the CMS
website at https://www.cms.gov/data-research/statistics-trends-and-reports/medicare-program-rates-statistics/market-basket-research-and-information. In addition, in the FY 2022 IPPS final rule (86 FR 45214),
we noted that beginning with FY 2022,
[[Page 23800]]
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 is 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 is 0.4 percentage point (based on
IGI's fourth quarter 2023 forecast). Therefore, the proposed hospice
payment update percentage for FY 2025 is 2.6 percent. We also propose
that if more recent data become available after the publication of this
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. Therefore, we are proposing to update hospice
payments using the methodology outlined and apply the 2018-based IPPS
market basket percentage increase for FY 2025 of 3.0 percent, reduced
by the statutorily required productivity adjustment of 0.4 percentage
point along with the wage index budget neutrality adjustment to update
the payment rates. For the FY 2025 hospice wage index, we are proposing
to use the FY 2025 pre-floor, pre-reclassified IPPS hospital wage index
with the proposed revised OMB labor market delineations as its basis.
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.
4. Proposed 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 are proposing to use FY 2023
claims data as of January 11, 2024 for the proposed FY 2025 payment
rate updates. We note that the budget neutrality factors and payment
rates will 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 proposed 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 proposed FY 2025 RHC rates are shown in Table 9. The FY 2025
payment rates for CHC, IRC, and GIP are shown in Table 10.
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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 two 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 two to four percentage points. 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. We applied this
policy beginning with the FY 2024 Annual Payment Update (APU), which we
based on CY 2022 quality data. Therefore, the proposed FY 2025 rates
for hospices that do not submit the required quality data would be
updated by -1.4 percent, which is the proposed FY 2025 hospice payment
update percentage of 2.6 percent minus four percentage points. These
rates are shown in Tables 11 and 12.
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5. Proposed 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. 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
of 2024 (CAA, 2024) (Pub. L. 118-42)
[[Page 23803]]
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 propose
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 is
$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 propose that if more recent data become available
after the publication of this 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.
B. Proposed Clarifying Regulation Text Changes
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
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 section
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 should be
proposed to the medical director CoP for clarity and consistency. To
align the medical director CoP and the hospice payment requirements, we
propose 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 propose to amend the medical director CoP 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 proposed rule for
additional proposals regarding the payment requirements for 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.
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) and
hospice medical director or physician member of the hospice
interdisciplinary group (IDG) to certify in writing at the beginning in
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 Conditions of Participation (CoP) 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 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
[[Page 23804]]
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 ``medical
director of the hospice'' or the ``physician member of the hospice
interdisciplinary group'' 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. In
order to align Sec. Sec. 418.22(b) and 418.25 with the CoPs at Sec.
418.102, we propose 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 are
clarifying that this does not connote a change in policy; rather we
believe aligning the language at Sec. Sec. 418.22(b) and 418.25 with
the CoPs at Sec. 418.102 allows for greater clarity and consistency
between key components of hospice regulations and policies.
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 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 Medicare Administrative
Contractor (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
propose to reorganize the language in this section to clearly denote
the differences between the election statement and the NOE. That is, we
are proposing to title Sec. 418.24(b) as ``Election Statement'' and
would include the title ``Notice of Election'' at Sec. 418.24(e). 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 align with existing subregulatory guidance. This reorganization
would not be a change in policy, rather it is intended to more clearly
identify the requirements 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 invite comments on the clarifying regulation text changes and
reorganization as described in sections II.B. of this proposed rule.
Finally, the MACs have informed us of ongoing instances of hospices
omitting certain elements of the hospice election statement. A complete
election statement containing all required elements as set forth at
Sec. 418.24(b) is a condition for payment. Additionally, we emphasize
the importance of each element in informing the beneficiary of their
coverage when choosing to elect the Medicare hospice benefit. We
continue to encourage hospice agencies to utilize the ``Model Example
of Hospice Election Statement'' on the hospice web page at https://www.cms.gov/medicare/payment/fee-for-service-providers/hospice to limit
potential claims denials.
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
interdisciplinary group (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
[[Page 23805]]
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 to those services that
enforce 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.\4\ 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
\5\ 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.\6\
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\4\ Obermeyer Z, Makar M, Abujaber S, Dominici F, Block S,
Cutler DM. Association Between 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.
\5\ 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.
\6\ Meier DE. Increased access to palliative care and hospice
services: opportunities to improve value in health care. Milbank Q.
2011Sep;89(3):343-80. doi: 10.1111/j.1468-0009.2011.00632.x. PMID:
21933272; PMCID:PMC3214714.
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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 are soliciting public comment on the following
questions:
What could eliminate the financial risk commenters
previously noted when providing complex palliative treatments and
higher intensity levels of hospice care?
What specific financial risks or costs are of particular
concern to hospices that would prevent the provision of higher-cost
palliative treatments when 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)?
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?
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?
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?
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?
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. 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
[[Page 23806]]
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 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:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
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.
BILLING CODE 4120-01-P
[[Page 23807]]
[GRAPHIC] [TIFF OMITTED] TP04AP24.023
BILLING CODE 4120-01-C
2. Proposal To Implement 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 proposed rule, we propose adding two process measures no sooner
than CY 2027 to the HQRP calculated from data collected from HOPE:
Timely Reassessment of Pain Impact and Timely Reassessment of Non-Pain
Symptom Impact. We propose to use the data collected from HOPE (see
section III. D 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. We propose these two measures would determine whether a
follow-up visit occurs within 48 hours 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.
[[Page 23808]]
Therefore, we propose these new concepts on timely reassessment 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/reassessment
within 48 hours to ensure treatment has helped alleviate and/or manage
those symptoms. Therefore, we are proposing two process measures
derived from HOPE data--Timely Reassessment of Pain Impact and Timely
Reassessment of Non-Pain Symptom Impact--would 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 and safer 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 https://p4qm.org/PRMR.
We also take into account 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 https://www.cms.gov/cciio/resources/forms-reports-and-other-resources/quality03212011a. 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 proposed Timely Reassessment of Pain Impact and
Timely Reassessment of Non-Pain Symptom Impact measures will add value
to HQRP by filling an identified informational gap in the current
measure set. Specifically, the proposed Timely Reassessment of Pain
Impact process measure will determine how many patients assessed with
moderate or severe pain impact were reassessed by the hospice within
two calendar days, and the proposed Timely Reassessment of 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 two calendar days. Compared to the single existing HQRP
measure that includes pain symptom assessment, the two proposed HOPE-
based process measures will better reflect hospices' efforts to
alleviate patients' symptoms on an ongoing basis.
b. Proposed Specifications of the Measures
We proposed 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 https://www.cms.gov/medicare/quality/hospice/hope and the PRA package that accompanies this proposed
rule can be accessed at https://www.cms.gov/medicare/regulations-guidance/legislation/paperwork-reduction-act-1995/pra-listing. We
propose that only in-person visits would count for the collection of
data for these proposed measures--that is, telehealth calls would not
count for a reassessment. We seek 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 propose 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).
For both the proposed Timely Reassessment of Pain Impact and
proposed Timely Reassessment of Non-Pain Symptom Impact measures, we
propose 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, we proposed that
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 reassessment visit, the
hospice was unable to contact the patient/caregiver to perform the
reassessment, 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, we propose that a hospice would be unable to conduct
a reassessment due to circumstances beyond their control, and therefore
these situations will not be included in the measure denominator.
We propose the numerators for these measures will reflect
beneficiaries who did receive a timely symptom re-assessment. These
will include beneficiaries who receive a separate HOPE reassessment
within two 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 reassessment 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 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 https://www.cms.gov/medicare/
[[Page 23809]]
quality/hospice/hope. 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 proposed process quality measures has thus far
relied on data from the HOPE beta (field) test. We propose 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 reassessment aligned with their usual practices. In
this proposed rule, we solicit public comments on these two process
measures.
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 Reassessment of Pain Impact and
Timely Reassessment of 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 (https://www.cms.gov/files/document/2023-hqrp-tep-summary-report.pdf and the
2023 Information Gathering Report, available on the HQRP Provider and
Stakeholder Engagement web page, or at https://www.cms.gov/files/document/hospicequalityreportingprograminformationgatheringreport2023508.pdf.
For further details about the ongoing development of these measures,
please visit the Partnership for Quality Measurement website: https://p4qm.org/ org/.
3. Proposal To Implement the Hospice Outcomes & Patient Evaluation
(HOPE) Assessment Instrument
Section 1814(i)(5)(C) of the Act requires that each hospice submit
data to the Secretary on quality measures specified by the Secretary.
The data must be submitted in a form, manner, and at a time specified
by the Secretary.
CMS has developed a new standardized patient level data collection
tool, the Hospice Outcomes & Patient Evaluation or HOPE. In past rules,
we have described this as a new collection tool, however we believe it
is better characterized as a modification of, and functional
replacement for, the existing HIS structure.
We propose to begin collecting the HOPE standardized patient level
data collection tool on or after October 1, 2025, for proposed quality
measures discussed in section 2. We propose that the HOPE assessment
instrument would replace the HIS upon implementation, as discussed in
section III. D6(b). In the FY 2020 Hospice Wage Index and Payment Rate
Update and Hospice Quality Reporting Requirements final rule (84 FR
38484), we finalized the instrument name and discussed the primary
objectives for HOPE. Specifically, HOPE would provide data for the HQRP
quality measures and its requirements through standardized data
collection; and provide additional clinical data that could inform
future payment refinements. All data collected by the instrument are
expected to be used for quality measures, as authorized under
section1814(i)(5)(C) of the Act, and only for quality measures under
section1814(i)(5)(D), of the Act, which will include the measures
Timely Reassessment of Pain Impact and Timely Reassessment of Non-Pain
Symptom Impact measures proposed in this Rule.
HOPE would be a component of implementing high-quality and safe
hospice care for patients, Medicare beneficiaries and non-beneficiaries
alike. HOPE would also contribute to the patient's plan of care through
providing patient data throughout the hospice stay. We propose to
collect data from multiple time points across the hospice stay, that
would inform hospice providers potentially resulting in improved
practice and care quality. Additional information about the draft HOPE
tool and the data elements included therein are available at https://www.cms.gov/medicare/quality/hospice/hope discussed in the
[[Page 23810]]
Paperwork Reduction Act submission for this collection (CMS-10390).
We stated in the FY 2022 Hospice Wage Index and Payment Update
final rule (86 FR 42528) that while the standardized patient assessment
data elements for certain post-acute care providers required under the
IMPACT Act of 2014 are not applicable to hospices, it would be
reasonable to include some of those standardized elements that could
appropriately and feasibly apply to hospice to the extent permitted by
our statutory authority. Many patients move through other providers
within the healthcare system to hospice. Therefore, considering
tracking key demographic and social risk factor items that apply to
hospice could support our goals for continuity of care, overall patient
care and well-being, development of infrastructure for the
interoperability of electronic health information, and health equity
which is also discussed in this proposed rule. CMS will propose any
additions of standardized elements in future rulemaking.
In the FY 2023 Hospice Final Rule (87 FR 45669), we outlined the
testing phases HOPE has undergone, including cognitive, pilot, alpha
testing, and national beta field testing. National beta testing,
completed at the end of October 2022, allowed us to obtain input from
participating hospice teams about the assessment instrument and field
testing to refine and support the final draft items and time points for
HOPE. It also allowed us to estimate the time to complete the HOPE
elements and establish the interrater reliability of each item. For
additional details and results from HOPE testing, see the HOPE Testing
Report, available in the Downloads section of the HOPE page of the HQRP
website.
We propose to adopt and implement HOPE as a standardized patient
element set to replace the current Hospice Item Set (HIS). HOPE v1.0
would contain demographic, record processing, and patient-level
standardized data elements that would be collected by all Medicare-
certified hospices for all patients over the age of 18, regardless of
payer source, to support HQRP quality measures. We propose new HOPE
data elements that are collected in real-time to assess patients based
on the hospice's interactions with the patient and family/caregiver,
accommodate patients with varying clinical needs, and provide
additional information to contribute to the patient's care plan
throughout the hospice stay (not just at admission and discharge).
These data elements represent domains such as Administrative,
Preferences for Customary Routine Activities, Active Diagnoses, Health
Conditions, Medications, and Skin Conditions. We propose that HOPE data
would be collected by hospice staff for each patient admission at three
distinct time points: admission, the hospice update visit (HUV), and
discharge, as discussed in the PRA as well as sections IV. A of this
proposed rule in which we discuss Collection of Information
requirements and the Regulatory Impact Analysis. We propose the
timepoint for the HOPE Update Visits (HUV), which is dependent on the
patient's length of stay (LOS), is limited to a subset of HOPE items
addressing clinical issues important to the care of hospice patients as
updates to the hospice plan of care. We propose that HOPE data be
collected at these timepoints during the hospice's routine clinical
assessments, based on unique patient assessment visits and additional
follow-up visits as needed. As further discussed in the proposed draft
HOPE Guidance Manual and PRA, not all HOPE items would be required to
be completed at every timepoint. These proposed time points could also
be revised in future rulemaking.
We propose that HOPE data collection would be effective beginning
on or after October 1, 2025 to support the proposed quality measures
anticipated for public reporting on or after CY 2027. After HOPE
implementation, hospices would no longer need to collect and submit the
Hospice Item Set (HIS). Additional details regarding the data
collection required for the new HOPE item set are discussed below in
section III. D6, Form, Manner, and Timing of Quality Measure Data
Submission, and section IV., Collection of Information.
We propose to update Sec. 418.312(a)(b)(1) to require hospices to
complete and submit a standardized set of items for each patient to
capture patient-level data, regardless of payer or patient age. This
proposed change is intended to take effect October 1, 2025. This update
will replace the previous requirement for hospices to complete the HIS
and the newly standardized set of items would have to be completed at
admission and discharge, and at the two HUV timepoints within the first
30 days after the hospice election. We note that, as authorized under
section1814(i)(5) of the Act, CMS would impose a 4 percent reduction on
hospices for failure to submit HOPE collections timely with respect to
that FY.
CMS is committed to ensuring hospices are ready for the proposed
data collection beginning on or after October 1, 2025. We propose to
provide information about upcoming provider trainings related to HOPE
v1.0 that will be posted on the CMS HQRP website on the Announcement
and Spotlight page and announced during Open Door Forums. Past
trainings about the HQRP are available through the HQRP Training and
Education Library. These trainings will help providers understand the
requirements necessary to be successful with the HQRP, including how
data collected via the new draft HOPE tool is submitted for quality
measures and contributes to compliance with the HQRP.
The draft HOPE Guidance Manual v1.0 is available on the HQRP HOPE
web page for review and the final HOPE Guidance Manual v1.0 will be
available after the publication of the final rule. This guidance manual
offers hospices direction on the collection and submission of hospice
patient stay data to CMS to support the HQRP quality measures.
Public Availability of Data Submitted
Under section 1814(i)(5)(E) of the Act, the Secretary is required
to establish procedures for making any quality measure data submitted
by hospices available to the public. The procedures ensure that a
hospice will have the opportunity to review the data regarding the
hospice's respective program before it is made public. In addition,
under section 1814(i)(5)(E) of the Act, the Secretary is authorized to
report data collected to support quality measures under section
1814(i)(5)(C) of the Act on the CMS website, that relate to services
furnished by a hospice. We recognize that public reporting of quality
measure data is a vital component of a robust quality reporting program
and are fully committed to developing the necessary systems for public
reporting of hospice quality measure data. We also recognize it is
essential that the data made available to the public be meaningful and
that comparing performance between hospices requires that measures be
constructed from data collected in a standardized and uniform manner.
The development and implementation of a standardized data set for
hospices should precede public reporting of hospice quality measures.
Once hospices have implemented the standardized data collection
approach, we will have the data needed to establish the scientific
soundness of the quality measures that can be calculated using the
standardized data. It is critical to establish the reliability and
validity of the measures prior to public reporting in order to
demonstrate the ability of the measures to distinguish the quality of
services provided. To establish reliability and validity of the quality
measures, at least four quarters of data
[[Page 23811]]
will need to be analyzed. Typically, the first two quarters of data
reflect the learning curve of the providers as they adopt a
standardized data collection; these data are not used to establish
reliability and validity. We propose that the data from the first
quarter (anticipated to be Q4 CY2025, if HOPE data collection begins in
October 2025) will not be used for assessing validity and reliability
of the quality measures.
We propose to assess the quality and completeness of the data that
we receive as we near the end of Q4 2025 before public reporting the
measures. Data collected by hospices during the four quarters of CY
2026 (for example, Q 1, 2, 3 and 4 CY 2026) will be analyzed starting
in CY 2027. We propose to inform the public of the decisions about
whether to report some or all of the quality measures publicly based on
the findings of analysis of the CY 2026 data.
In addition, as noted, the Affordable Care Act requires that
reporting on the quality measures adopted under section 1814(i)(5)(D)
of the Act be made public on a CMS website and that providers have an
opportunity to review their data prior to public reporting. In light of
all the steps required prior to data being publicly reported, we
propose that public reporting of the proposed quality measures will be
implemented no earlier than FY 2027. Alternatively, we propose public
reporting may occur during the FY 2028 APU year, allowing ample time
for data analysis, review of measures' appropriateness for use for
public reporting, and allowing hospices the required time to review
their own data prior to public reporting.
CMS will consider public reporting using fewer than four (4)
quarters of data for the initial reporting period, but we propose to
use 4 quarters of data as the standard reporting period for future
public reporting. If the initial reporting period would include any
excluded quarters of data, we propose to use as many non-excluded
quarters of data as are included in the reporting period for public
reporting. For example, if the first reporting period includes Q4 2024
2025 through Q3 2025 2026, then public reporting of HOPE will be based
on Q1 2025 2026, Q2 2025 2026, and Q3 2025 2026. The next public
reporting period would include Q1 2025 2026-Q4 2025 2026, and public
reporting would be based on four (4) quarters of data, as would all
subsequent rolling reporting periods.
We will propose the timeline for public reporting of data in future
rulemaking and we welcome public comment on what we should consider
when developing future proposals related to public reporting.
4. Health Equity Updates Related to HQRP
a. Background
Universal Foundation
To further the goals of the CMS National Quality Strategy (NQS),
CMS leaders from across the Agency have come together to move towards a
building-block approach to streamline quality measures across CMS
quality programs for the adult and pediatric populations. We believe
that this ``Universal Foundation'' of quality measures will focus
provider attention, reduce burden, identify disparities in care,
prioritize development of interoperable, digital quality measures,
allow for cross-comparisons across programs, and help identify
measurement gaps. The development and implementation of the Preliminary
Adult and Pediatric Universal Foundation Measures will promote the
best, safest, and most equitable care for individuals. As CMS moves
forward with the Universal Foundation, we will be working to identify
foundational measures in other specific settings and populations to
support further measure alignment across CMS programs as applicable.
TEP Recommendations
In November and December 2022, CMS convened a group of stakeholders
to provide input on the health equity measure development process. This
HQRP and HH QRP Health Equity Structural Composite Measure Development
Technical Expert Panel (or Home Health & Hospice HE TEP) included
health equity experts from hospice and home health settings
specializing in quality assurance, patience advocacy, clinical work,
and measure development.
The TEP largely supported the potential health equity measure
domains of Equity as a Key Organizational Priority, Trainings for
Health Equity, and Organizational Culture of Equity. The TEP also
recommended that CMS not only measure equity in service provision, but
also equity in access to services. TEP members raised concerns about
collecting hospice quality measure data from family or caregivers of
hospice decedents rather than collecting data directly from patients
while they are receiving care. Vulnerable populations without contacts
post-mortem may be left out of data collection, such as hospice
patients who do not have family members to help with their care or
unhoused people. This feedback highlighted the importance of including
SDOH such as housing instability in hospice quality reporting. Hospice
TEP members also recommended adding specific questions to the
CAHPS[supreg] survey about cultural sensitivity.
Additional information regarding the Home Health & Hospice HE TEP
are available in the TEP Report, available on the Hospice QRP Health
Equity web page: https://www.cms.gov/medicare/quality/hospice/hospice-qrp-health-equity.
b. Request for Information (RFI) Regarding Future HQRP Social
Determinants of Health (SDOH) Items
CMS is committed to developing approaches to meaningfully
incorporate the advancement of health equity into the HQRP. One
consideration is including social determinants of health (SDOH) into
our quality measures and data stratification. SDOH are the
socioeconomic, cultural, and environmental circumstances in which
individuals live that impact their health. SDOH can be grouped into
five broad domains: economic stability; education access and quality;
health care access and quality; neighborhood and built environment; and
social and community context. Health-related social needs (HRSNs) are
the resulting effects of SDOH, which are individual-level, adverse
social conditions that negatively impact a person's health or health
care. Examples of HRSN include lack of access to food, housing, or
transportation, and have been associated with poorer health outcomes,
greater use of emergency departments and hospitals, and higher health
care costs. Certain HRSNs can lead to unmet social needs that directly
influence an individual's physical, psychosocial, and functional
status. This is particularly true for food security, housing stability,
utilities security, and access to transportation. In recent years, we
have addressed SDOH through the identification and standardization of
screening for HRSN, including finalizing several standardized patient
assessment data requirements for post-acute care providers \7\ and
testing the
[[Page 23812]]
Accountable Health Communities (AHC) model under section 1115A of the
Social Security Act.\8\
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\7\ See the ``Medicare and Medicaid Programs: CY 2020 Home
Health Prospective Payment System Rate Update; Home Health Value-
Based Purchasing Model; Home Health Quality Reporting Requirements;
and Home Infusion Therapy Requirements'' final rule (84 FR 39151) as
an example. In the interim final rule with comment period (IFC)
``Medicare and Medicaid Programs, Basic Health Program and
Exchanges; Additional Policy and Regulatory Revisions in Response to
the COVID-19 Public Health Emergency and Delay of Certain Reporting
Requirements for the Skilled Nursing Facility Quality Reporting
Program'' (85 FR 27550 through 27629), CMS delayed the compliance
dates for these standardized patient assessment data under the
Inpatient Rehabilitation Facility (IRF) Quality Reporting Program
(QRP), Long-Term Care Hospital (LTCH) QRP, Skilled Nursing Facility
(SNF) QRP, and the Home Health (HH) QRP due to the public health
emergency. In the ``CY 2022 Home Health Prospective Payment System
Rate Update; Home Health Value-Based Purchasing Model Requirements
and Model Expansion; Home Health and Other Quality Reporting Program
Requirements; Home Infusion Therapy Services Requirements; Survey
and Enforcement Requirements for Hospice Programs; Medicare Provider
Enrollment Requirements; and COVID-19 Reporting Requirements for
Long-Term Care Facilities'' final rule (86 FR 62240 through 62431),
CMS finalized its proposals to require collection of standardized
patient assessment data under the IRF QRP and LTCH QRP effective
October 1, 2022, and January 1, 2023, for the HH QRP.
\8\ The Accountable Health Communities Model is a nationwide
initiative established by the Center for Medicare and Medicaid
Innovation Center to test innovative payment and service delivery
models that have the potential to reduce Medicare, Medicaid, and
Children's Health Insurance Program expenditures while maintaining
or enhancing the quality of beneficiaries care and was based on
emerging evidence that addressing health-related social needs
through enhanced clinical-community linkages can improve health
outcomes and reduce costs. More information can be found at: https://www.cms.gov/priorities/innovation/innovation-models/ahcm.
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We have repeatedly heard from the public that CMS should develop
new HQRP mechanisms to better address significant and persistent health
care outcome inequities. For example, in the FY 2022 Hospice Wage Index
final rule, we received comments supportive of gathering standardized
patient assessment data elements and additional SDOH data to improve
health equity. In the FY 2023 Hospice final rule, we again received
comments highlighting the need for more sociodemographic and SDOH data
to effectively evaluate health equity in hospice settings. Commenters
suggested that CMS consider standardizing the sociodemographic and SDOH
data collected across provider settings and across third party vendors
(for example, EMRs) and other tools. To this end, CMS expects to seek
endorsement under 1890(a) for measures that would utilize SDOH data,
within HQRP.
We are committed to achieving health equity in health care outcomes
for our beneficiaries, including by improving data collection to better
measure and analyze disparities across programs and policies.\9\ We
believe that the ongoing measurement of SDOHs will have two significant
benefits. First, because SDOHs disproportionately impact underserved
communities, promoting measurement of these factors may serve as
evidence-based building blocks for supporting healthcare providers and
health systems in actualizing commitment to address disparities,
improving health equity through addressing the social needs with
community partners, and implementing associated equity measures to
track progress.\10\ By measuring patient SDOH providers would be better
equipped to identify disparities in patient populations and health
outcomes. Better SDOH quality measures would serve as evidence-based
building blocks for informing more effective programs to target and
mitigate disparities, thereby enabling providers to improve patient
outcomes.
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\9\ Centers for Medicare & Medicaid Services. CMS Quality
Strategy. 2016. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
\10\ American Hospital Association. (2020). Health Equity,
Diversity & Inclusion Measures for Hospitals and Health System
Dashboards. December 2020. Accessed: January 18, 2022. Available at:
https://ifdhe.aha.org/system/files/media/file/2020/12/ifdhe_inclusion_dashboard.pdf.
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Second, these factors could support ongoing HQRP initiatives by
providing data with which to measure stratified resident risk and
organizational performance. Further, we believe measuring resident-
level SDOH through screening is essential in the long-term in
encouraging meaningful collaboration between healthcare providers and
community-based organizations, as well as in implementing and
evaluating related innovations in health and social care delivery.
Analysis of SDOH measures could allow providers to more effectively
identify patient needs and identify opportunities for effective
partnership with community-based organizations with the capacity to
help address those needs. Thorough SDOH measures would also provide a
better evidence base for evaluating the effectiveness and
appropriateness of health and social care delivery innovations. The
SDOH category of standardized patient assessment data elements could
provide hospices and policymakers with meaningful measures as we seek
to reduce disparities and improve care for beneficiaries with social
risk factors. SDOH measures would also permit us to develop the
statistical tools necessary to reduce costs and improve the quality of
care for all beneficiaries. We note that advancing health equity by
addressing the health disparities that underlie the country's health
system is one of our strategic pillars \11\ and a Biden-Harris
Administration priority.\12\ As such, CMS is working toward collecting
SDOH data elements in hospice in support of quality measurement and
seeks public comment on these efforts.
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\11\ Brooks-LaSure, C. (2021). My First 100 Days and Where We Go
from Here: A Strategic Vision for CMS. Centers for Medicare &
Medicaid. Available at: https://www.cms.gov/blog/my-first-100-days-and-where-we-go-here-strategic-vision-cms.
\12\ The White House. The Biden-Harris Administration Immediate
Priorities [website]. https://www.whitehouse.gov/priorities/.
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CMS reviewed SDOH domains to determine which domains align across
post-acute care (PAC) and hospice care settings, circumstances, and
setting-specific care goals. CMS identified four SDOH domains that are
relevant across the PAC and hospice care setting: housing instability,
food insecurity, utility challenges, and barriers to transportation
access. These data elements have supported measures of quality in other
settings. For example, as of 2023 the Hospital Inpatient Quality
Reporting Program mandates reporting on the ``Screening for Social
Drivers of Health'' and ``Screen Positive Rate for Social Drivers of
Health'' measures.
CMS requests input on which of the data collection items outlined
below are suitable for the hospice setting, and how they may need to be
adapted to be more appropriate for the hospice setting.
Housing Instability
Healthy People 2030 prioritizes economic stability as a key SDOH,
of which housing stability is a component.13 14 Lack of
housing stability encompasses several challenges, such as having
trouble paying rent, overcrowding, moving frequently, or spending the
bulk of household income on housing.\15\ These experiences may
negatively affect physical health and make it harder to access health
care. Lack of housing stability can also lead to homelessness, which is
housing deprivation in its most severe form. Homelessness is defined as
``lacking a regular nighttime residence or having a primary nighttime
residence that is a temporary shelter or other place not designed for
sleeping.'' \16\ On a single night in 2023, roughly 653,100 people, or
20 out of every 10,000 people in the United States, were experiencing
[[Page 23813]]
homelessness.\17\ Studies also found that newly homeless people have an
increased risk of premature death and experience chronic disease more
often than among the general population.
---------------------------------------------------------------------------
\13\ https://health.gov/healthypeople/priority-areas/social-determinants-health.
\14\ Healthy People 2030 is a long-term, evidence-based effort
led by the U.S. Department of Health and Human Services (HHS) that
aims to identify nationwide health improvement priorities and
improve the health of all Americans.
\15\ Kushel, M.B., Gupta, R., Gee, L., & Haas, J.S. (2006).
Housing instability and food insecurity as barriers to health care
among low-income Americans. Journal of General Internal Medicine,
21(1), 71-77. doi: 10.1111/j.1525-1497.2005.00278.x.
\16\ https://health.gov/healthypeople/priority-areas/social-determinants-health/literature-summaries/housing-instability.
\17\ The 2023 Annual Homeless Assessment Report (AHAR) to
Congress. The U.S. Department of Housing and Urban Development 2023.
https://www.huduser.gov/portal/sites/default/files/pdf/2023-AHAR-Part-1.pdf.
---------------------------------------------------------------------------
The following options were identified as potential complimentary
items to collect housing information, in addition to proposed HOPE item
A1905--Living Arrangements.
[GRAPHIC] [TIFF OMITTED] TP04AP24.024
Food Insecurity
The U.S. Department of Agriculture, Economic Research Service
defines a lack of food security as a household-level economic and
social condition of limited or uncertain access to adequate food.\18\
Food insecurity has been a priority for the Biden-Harris
Administration, with the White House recently announcing 141
stakeholder funding commitments to support the White House Challenge to
End Hunger and Build Healthy Communities.\19\ Adults who are food
insecure may be at an increased risk for a variety of negative health
outcomes and health disparities. For example, a study found that food-
insecure adults may be at an increased risk for obesity.\20\ Nutrition
security is also an important component that builds on and complements
long standing efforts to advance food security. The United States
Department of Agriculture (USDA) defines nutrition security as
``consistent and equitable access to healthy, safe, affordable foods
essential to optimal health and well-being.'' \21\ While having enough
food is one of many predictors for health outcomes, a diet low in
nutritious foods is also a factor.\22\ Studies have shown that older
adults struggling with food security consume fewer calories and
nutrients and have lower overall dietary quality than those who are
food secure, which can put them at nutritional risk. Older adults are
also at a higher risk of developing malnutrition, which is considered a
state of deficit, excess, or imbalance in protein, energy, or other
nutrients that adversely impacts an individual's own body form,
function, and clinical outcomes. About 50 percent of older adults are
affected by malnutrition, which is further aggravated by a lack of food
security and poverty.\23\
---------------------------------------------------------------------------
\18\ U.S. Department of Agriculture, Economic Research Service.
(n.d.). Definitions of food security. Retrieved March 10, 2022, from
https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-u-s/definitions-of-food-security/.
\19\ https://www.whitehouse.gov/briefing-room/statements-releases/2024/02/27/fact-sheet-the-biden-harris-administration-announces-nearly-1-7-billion-in-new-commitments-cultivated-through-the-white-house-challenge-to-end-hunger-and-build-healthy-communities/.
\20\ Hernandez, D.C., Reesor, L.M., & Murillo, R. (2017). Food
insecurity and adult overweight/obesity: Gender and race/ethnic
disparities. Appetite, 117, 373-378.
\21\ Food and Nutrition Security. (n.d.). USDA. https://www.usda.gov/nutrition-security.
\22\ National Center for Health Statistics. (2022, September 6).
Exercise or Physical Activity. Retrieved from Centers for Disease
Control and Prevention: https://www.cdc.gov/nchs/fastats/exercise.htm.
\23\ Food Research & Action Center (FRAC). ``Hunger is a Health
Issue for Older Adults: Food Security, Health, and the Federal
Nutrition Programs.'' December 2019. https://frac.org/wp-content/uploads/hunger-is-a-health-issue-for-older-adults-1.pdf.
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[[Page 23814]]
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Utility Challenges
A lack of energy (utility) security can be defined as an inability
to adequately meet basic household energy needs.\24\ According to the
Department of Energy, one in three households in the US are unable to
adequately meet basic household energy needs.\25\ The consequences
associated with a lack of utility security are represented by three
primary dimensions: economic, physical, and behavioral. Individuals
with low incomes are disproportionately affected by high energy costs,
and they may be forced to prioritize paying for housing and food over
utilities. Some people may face limited housing options and are at
increased risk of living in lower-quality physical conditions with
malfunctioning heating and cooling systems, poor lighting, and outdated
plumbing and electrical systems. Finally, individuals who lack of
utility security may use negative behavioral approaches to cope, such
as using stoves and space heaters for heat.\26\ In addition, data from
the Department of Energy's US Energy Information Administration confirm
that a lack of energy security disproportionately affects certain
populations, such as low-income and African American households.\27\
The effects of a lack of utility security include vulnerability to
environmental exposures such as dampness, mold, and thermal discomfort
in the home, which have direct effect on residents' health. For
example, research has shown associations between a lack of energy
security and respiratory conditions as well as mental health-related
disparities and poor sleep quality in vulnerable populations such as
the elderly, children, the socioeconomically disadvantaged, and the
medically vulnerable.\28\ Adopting a data element to collect
information about utility security across PAC settings could facilitate
the identification of residents who may not have utility security and
who may benefit from engagement efforts.
---------------------------------------------------------------------------
\24\ Hern[aacute]ndez D. Understanding 'energy insecurity' and
why it matters to health. Soc Sci Med. 2016 Oct; 167:1-10. doi:
10.1016/j.socscimed.2016.08.029. Epub 2016 Aug 21. PMID: 27592003;
PMCID: PMC5114037.
\25\ U.S. Energy Information Administration. ``One in Three U.S.
Households Faced Challenges in Paying Energy Bills in 2015.'' 2017
Oct 13. https://www.eia.gov/consumption/residential/reports/2015/energybills/.
\26\ Hern[aacute]ndez D. ``What `Merle' Taught Me About Energy
Insecurity and Health.'' Health Affairs, VOL.37, NO.3: Advancing
Health Equity Narrative Matters. March 2018. https://doi.org/10.1377/hlthaff.2017.1413.
\27\ US Energy Information Administration. ``One in Three U.S.
Households Faced Challenges in Paying Energy Bills in 2015.'' 2017
Oct 13. https://www.eia.gov/consumption/residential/reports/2015/energybills/.
\28\ Hern[aacute]ndez D. ``Understanding `energy insecurity' and
why it matters to health.'' Soc Sci Med. 2016; 167:1-10.
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[[Page 23815]]
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Transportation Challenges
Transportation barriers can both directly and indirectly affect a
person's health. A lack of transportation can keep patients from
accessing medical appointments, getting medications, or from getting
things they need daily. It can also affect a person's health by
creating a barrier to accessing goods and services, obtaining adequate
food and clothing, or attending social activities. Therefore, reliable
transportation services are fundamental to a person's health.
[GRAPHIC] [TIFF OMITTED] TP04AP24.027
All Domains
[[Page 23816]]
[GRAPHIC] [TIFF OMITTED] TP04AP24.028
We solicit public comment on the following questions:
For each of the domains:
++ Are these items relevant for hospice patients? Are these items
relevant for hospice caregivers?
++ Which of these items are most suitable for hospice?
++ How might the items need to be adapted to improve relevance for
hospice patients and their caregivers? Would you recommend adjusting
the listed timeframes for any items? Would you recommend revising any
of the items' response options?
Are there additional SDOH domains that would also be
useful for identifying and addressing health equity issues in Hospice?
5. Proposed CAHPS Hospice Survey and Measure Changes
a. Survey and Measure Changes
In the Fiscal Year 2024 Hospice Payment Rate Update Final Rule (88
FR 51164), CMS provided the results of a mode experiment conducted with
56 large hospices in 2021. The experiment tested a web-mail mode,
modification to survey administration protocols such as adding a
prenotification letter and extending the data collection period, and a
revised survey version. Because we believe the results of the
experiment were successful, we are proposing changes to the CAHPS
Hospice Survey and administrative protocol. The revised survey is
shorter and simpler than the current survey and includes new questions
on topics suggested by stakeholders. Specifically, proposed changes to
the survey and the quality measures derived from testing include:
Removal of three nursing home items and an item about
moving the family member \29\ that are not included in scored measures.
---------------------------------------------------------------------------
\29\ The current version of the CAHPS Hospice Survey is
available at: https://hospicecahpssurvey.org/en/survey-materials/.
The proposed items are for removal from this version of the survey
are: Question 32 through 34 (nursing home items), Question 30 (item
about moving a family member), Question 10 (item regarding confusing
or contradictory information), and Question 17 through 20, 23, 28,
and 29 (screening and evaluative items used to calculate the Getting
Hospice Care Training measure).
---------------------------------------------------------------------------
Removal of one survey item regarding confusing or
contradictory information from the Hospice Team Communication
measure.\30\
---------------------------------------------------------------------------
\30\ Ibid.
---------------------------------------------------------------------------
Replacement of the multi-item Getting Hospice Care
Training measure \31\ with a new, one-item summary measure.
---------------------------------------------------------------------------
\31\ Ibid.
---------------------------------------------------------------------------
Addition of two new items, which will be used to calculate
a new Care Preferences measure.
Simplified wording to component items in the Hospice Team
Communication, Getting Timely Care, and Treating Family Member with
Respect measures.
The revised CAHPS Hospice Survey, including the new Care
Preferences measure, the revised Hospice Team Communication measure,
and the revised Getting Hospice Care Training measure received
endorsement through the Consensus Standards Approval Committee (CSAC)
Fall 2022 endorsement and maintenance cycle. Recommendations from the
endorsement committee resulted in edits to the Getting Emotional and
Religious Support to reflect cultural needs.
The Care Preferences, Hospice Team Communication, and Getting
Hospice Care Training measures are on the 2023 Measures Under
Consideration list (MUC2023-183,191 & 192) and are under evaluation by
the Pre-Rulemaking Measure Review (PRMR) Post-Acute Care/Long-Term Care
(PAC/LTC) Committee. The Consensus-Based Entity (CBE) utilizes the
Novel Hybrid Delphi and Nominal Group (NHDNG) multi-step process, which
is an iterative consensus-building approach aimed at a minimum of 75
percent agreement among voting members, rather than a simple majority
vote, and supports maximizing the time spent to build consensus by
focusing discussion on measures where there is disagreement. The final
result from the committee's vote can be: ``Recommend'', ``Recommend
with conditions'', ``Do not recommend'' or ``Consensus not reached''.
``Consensus not reached'' signals continued disagreement amongst the
committee despite being presented with perspectives from public
comment, committee member feedback and discussion, and highlights the
multi-faceted assessments of quality measures. The CBE did not reach
consensus on the CAHPS Hospice Survey measures. More details regarding
the CBE Pre-Rulemaking Measure Review (PRMR) voting procedures may be
found in Chapter 4 of the Guidebook of Policies and Procedures for Pre-
Rulemaking Measure Review and Measure Set Review.
CMS is proposing to implement the revised CAHPS Hospice Survey
beginning with January 2025 decedents. Table 14 provides a comparison
of the current and proposed CAHPS Hospice Survey measures.
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We seek comment on these proposed changes before finalization.
b. Impact to Public Reporting and Star Ratings
CAHPS Hospice Survey measure scores are calculated across eight
rolling quarters and are published quarterly for all hospices with 30
or more completed surveys over the reporting period. The Family
Caregiver Survey Rating summary Star Rating is also calculated using
eight rolling quarters and is publicly reported for all hospices with
75 or more completed surveys over the reporting period. Star Ratings
are updated every other quarter. To determine what impact the changes
to the survey measures would have on public reporting, CMS considered
the nature of the measure change. As ``Care Preferences'' would be a
new measure for the CAHPS Hospice Survey, we would have to wait to
introduce public reporting until we have eight quarters of data.
Although the revised ``Getting Hospice Care Training'' measure would be
conceptually similar to the current ``Getting Hospice Care Training''
measure, we believe the change (one summary item instead of several
items) is substantive and the revised measure should be treated as new
for purposes of public reporting and Star Ratings. As such, we propose
waiting to publicly report the new version of ``Getting Hospice Care
Training'' until we have eight quarters of data. We anticipate that the
first Care Compare refresh in which publicly reported measures scores
would be updated to include the new measures would be November 2027,
with scores calculated using data from Q1 2025 through Q4 2026. Because
measure scores are calculated quarterly and Star Ratings are calculated
every other quarter, these changes may be introduced in different
quarters for measure scores and Star Ratings. In the interim period,
measure scores would be made available to hospices confidentially in
their Provider Preview reports once they met a threshold number of
completed surveys.
We believe the proposed changes to the ``Hospice Team
Communication'' measure (removing one item and slight wording changes)
are non-substantive (that is, would not meaningfully change the
measure) and that the measure could continue to be publicly reported
and used in Star Ratings in the transition period between the current
and new
[[Page 23823]]
surveys. During the transition period, scores and Star Ratings would be
calculated by combining scores from quarters using the current and new
survey. As a result of the survey measure changes, we propose that the
Family Caregiver Survey Rating summary Star Rating will be based on
seven measures rather than the current eight measures during the
interim period until a full eight quarters of data are available for
the ``Getting Hospice Care Training'' measure. The summary Star Rating
would be based on nine measures once eight quarters of data are
available for the new Care Preference and Getting Hospice Care Training
measures.
c. Survey Administration Changes
CMS is proposing to add a web-mail mode (email invitation to a web
survey, with mail follow-up to non-responders); to add a pre-
notification letter; and to extend the field period from 42 to 49 days,
beginning with January 2025 decedents. The 2021 mode experiment found
increases to response rates with these changes to survey administrative
protocols. The web-mail mode would be an alternative to the current
modes (mail-only, telephone-only, and mixed mode (mail with telephone
follow-up)) that hospices could select. In the mode experiment, among
those with no available email addresses, response rates to the mail-
only and web-mail modes were similar (35.2 percent vs. 34.3 percent);
however, among those with available email addresses, adjusted response
rates were substantially and significantly different--36.7 percent for
mail-only versus 49.6 percent for web-mail--suggesting a notable
benefit of the web-mail mode for hospices with available email
addresses for some caregivers.
In the mode experiment, we found that mailing a pre-notification
letter one week prior to survey administration was associated with an
increase in response rates of 2.4 percentage points. We currently
require a prenotification letter for the Medicare Advantage and
Prescription Drug Plan and the In-center Hemodialysis CAHPS
initiatives, so there is precedent for this requirement for CAHPS
surveys, and mailing the letter is well within the capabilities of all
approved survey vendors.
Currently, the CAHPS Hospice Survey is fielded over 42 days;
responses that come in after the 42-day window are not included in
analysis and scoring. Extending the field period by one week (to 49
days) is feasible within the current national implementation data
collection and submission timeline. Our proposal to extend the field
period to 49 days is estimated to result in an increased response rate
of 2.5 percentage points in the mail-only mode, the predominant mode in
which CAHPS Hospice Surveys are currently administered.
d. Case-Mix and Mode Adjustments
Prior to public reporting, hospices' CAHPS Hospice Survey scores
are adjusted for the effects of both mode of survey administration and
case mix. Case mix refers to characteristics of the decedent and the
caregiver that are not under control of the hospice that may affect
reports of hospice experiences. Case-mix adjustment is performed within
each quarter of data after data cleaning and mode adjustment. The
current case-mix adjustment model includes the following variables:
response percentile (the lag time between patient death and survey
response), decedent's age, payer for hospice care, decedent's primary
diagnosis, decedent's length of final episode of hospice care,
caregiver's education, decedent's relationship to caregiver,
caregiver's preferred language and language in which the survey was
completed, and caregiver's age. CMS reviewed the variables included in
the case-mix adjustment models currently in use for the CAHPS Hospice
Survey to determine if any changes needed to be introduced along with
the revised survey and new mode. We found that no case-mix variables
need to be added or removed.
With the introduction of a new mode of survey administration and
survey items, CMS proposes updating the analytic adjustments that
adjust responses for the effect of mode on survey responses. When we
make mode adjustments, it is necessary to choose one mode as a
reference mode. One can then interpret all adjusted responses from all
modes as if they had been surveyed in the reference mode. Telephone-
only is currently the reference mode for the CAHPS Hospice Survey. We
are proposing to change the reference mode to mail-only. In the 2015
CAHPS Hospice Survey mode experiment, telephone-only respondents had
consistently worse scores than mail-only respondents across measures.
However, in the 2021 mode experiment, differences in scores between
mail-only and telephone-only respondents were no longer in a consistent
direction across measures. Given this, we are proposing to use mail-
only as the reference mode beginning with January 2025 decedents as
most surveys are currently completed in the mail-only mode. We invite
public comment on the CAHPS Hospice Survey proposals.
6. Form, Manner, and Timing of Quality Measure Data Submission
a. Statutory Penalty for Failure To Report
Section 1814(i)(5)(C) of the Act requires that each hospice submit
data to the Secretary on quality measures specified by the Secretary.
The data must be submitted in a form and manner, and at a time
specified by the Secretary. Section 1814(i)(5)(A)(i) of the Act was
amended by the CAA, 2021 and the payment reduction for failing to meet
hospice quality reporting requirements was increased from 2 percent to
4 percent beginning with FY 2024. During FYs 2014 through 2023, the
Secretary reduced the market basket update by 2 percentage points for
non-compliance. Beginning in FY 2024 and for each subsequent year, the
Secretary will reduce the market basket update by 4 percentage points
for any hospice that does not comply with the quality measure data
submission requirements for that FY. In the FY 2023 Hospice Wage Index
final rule (87 FR 45669), we revised our regulations at Sec.
418.306(b)(2) in accordance with this statutory change (86 FR 42605).
b. HOPE Data Collection
Hospices will be required to begin collecting and submitting HOPE
data as of October 1, 2025. After this effective date, hospices will no
longer be required to collect or submit the Hospice Item Set (HIS).
We propose that hospices begin the use of HOPE in October 2025 and
submit HOPE assessments to the CMS data submission and processing
system in the required format designated by CMS (as set out in
subregulatory guidance). At the time of implementation (that is,
October 2025), all HOPE records would need to be submitted as an XML
file, which is also the required format for the HIS. The format is
subject to change in future years as technological advancements occur
and healthcare provider use of electronic records increases, as well as
systems become more interoperable.
We will provide the HOPE technical date specifications for software
developers and vendors on the CMS website. Software developers and
vendors should not wait for final technical data specifications to
begin development of their own products. Rather, software developers
and vendors are encouraged to thoroughly review the draft technical
data specifications and provide feedback to CMS so we may address
potential issues adequately and in a timely manner. We will conduct a
call with software developers and
[[Page 23824]]
vendors after the draft specifications are posted, during which we will
respond to questions, comments, and suggestions. This process will
ensure software developers and vendors are successful in developing
their products to better support the successful implementation of HOPE
for all parties. Hospice providers will need to use vendor software to
submit HOPE records to CMS. As with HIS, facilities that fail to submit
all required HOPE assessments to CMS for at least 90% of their patients
will be subject to a 4% reduction. See ``Submission of Data
Requirements'' section below for additional information.
c. Retirement of Hospice Abstraction Reporting Tool (HART)
In 2014, CMS made a free tool (Hospice Abstraction Reporting Tool,
or HART) available which providers could use to collect HIS data. Over
time we observed that only a small percentage of hospices utilized the
tool. Therefore, in light of the limited utility the free tool
provided, we will no longer provide a free tool for standardized data
collection. Beginning October 1, 2025, hospices will need to select a
private vendor to collect and submit HIS data, and subsequently HOPE
data, to CMS.
d. Compliance
HQRP Compliance requires understanding three timeframes for both
HIS and CAHPS: The relevant Reporting Year; the payment FY; and the
Reference Year.
(1) The ``Reporting Year'' (HIS) or ``Data Collection Year''
(CAHPS) is based on the calendar year (CY). It is the same CY for both
HIS (or HOPE, once it is implemented) and CAHPS. If the CAHPS Data
Collection year is CY 2025, then the HIS (or HOPE) reporting year is
also CY 2025.
(2) In the ``Payment FY'', the APU is subsequently applied to FY
payments based on compliance in the corresponding Reporting Year/Data
Collection Year.
(3) For the CAHPS Hospice Survey, the Reference Year is the CY
before the Data Collection Year. The Reference Year applies to hospices
submitting a size exemption from the CAHPS survey (there is no similar
exemption for HIS or HOPE). For example, for the CY 2025 data
collection year, the Reference Year is CY 2024. This means providers
seeking a size exemption for CAHPS in CY 2025 will base it on their
hospice size in CY 2024.
Submission requirements are codified at 42 CFR 418.312. Table 15
summarizes the three timeframes. It illustrates how the CY interacts
with the FY payments, covering the CY 2023 through CY 2026 data
collection periods and the corresponding APU application from FY 2025
through FY 2028. Please note that during the first reporting year that
implements HOPE, APUs may be based on fewer than four quarters of data.
CMS will provide additional subregulatory guidance regarding APUs for
the HOPE implementation year.
[GRAPHIC] [TIFF OMITTED] TP04AP24.035
As illustrated in Table 15 CY 2023 data submissions compliance
impacts the FY 2025 APU. CY 2024 data submissions compliance impacts
the FY 2026 APU. CY 2025 data submissions compliance impacts FY 2027
APU. This CY data submission impacting FY APU pattern follows for
subsequent years.
e. Submission of Data Requirements
As finalized in the FY 2016 Hospice Wage Index final rule (80 FR
47142, 47192), hospices' compliance with HIS requirements beginning
with the FY 2020 APU determination (that is, based on HIS-Admission and
Discharge records submitted in CY 2018) are based on a timeliness
threshold of 90 percent. This means CMS requires that hospices submit
90 percent of all required HIS records within 30 days of the event
(that is, patient's admission or discharge). The 90-percent threshold
is hereafter referred to as the timeliness compliance threshold. Ninety
percent of all required HIS records must be submitted and accepted
within the 30-day submission deadline to avoid the statutorily-mandated
payment penalty.
We propose to apply the same submission requirements for HOPE
admission, discharge, and two HUV records. After HIS is phased out,
hospices would continue to submit 90 percent of all required HOPE
records to support the quality measures within 30 days of the event or
completion date (patient's admission, discharge, and based on the
patient's length of stay up to two HUV timepoints).
Hospice compliance with claims data requirements is based on
administrative data collection. Since Medicare claims data are already
collected from claims, hospices are considered 100 percent compliant
with the submission of these data for the HQRP. There is no additional
submission requirement for administrative data.
To comply with CMS' quality reporting requirements for CAHPS,
hospices are required to collect data monthly using the CAHPS Hospice
Survey. Hospices comply by utilizing a CMS-approved third-party vendor.
Approved Hospice CAHPS vendors must successfully submit data on the
hospice's behalf to the CAHPS Hospice Survey Data Center. A list of the
approved vendors can be found on the
[[Page 23825]]
CAHPS Hospice Survey website: www.hospicecahpssurvey.org.
Table 16. HQRP Compliance Checklist illustrates the APU and
timeliness threshold requirements.
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[GRAPHIC] [TIFF OMITTED] TP04AP24.036
BILLING CODE 4120-01-C
Most hospices that fail to meet HQRP requirements do so because
they miss the 90 percent threshold. We offer many training and
education opportunities through our website, which are available 24/7,
365 days per year, to enable hospice staff to learn at the pace and
time of their choice. We want hospices to be successful with meeting
the HQRP requirements. We encourage hospices to use the website at:
https://www.cms.gov/Medicare/Quality-
[[Page 23826]]
Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/
Hospice-Quality-Reporting-Training-Training-and-Education-Library. For
more information about HQRP Requirements, we refer readers to visit the
frequently-updated HQRP website and especially the Requirements and
Best Practice, Education and Training Library, and Help Desk web pages
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting. We also encourage
readers to visit the HQRP web page and sign-up for the Hospice Quality
ListServ to stay informed about HQRP.
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
A. Hospice Outcomes & Patient Evaluation (HOPE)
As proposed in section III. of this proposed rule, we are proposing
the use of HOPE to collect QRP information through revisions to Sec.
418.312(b). We are also proposing to require HOPE as a hospice patient-
level item set to be used by all hospices to collect and submit
standardized data on each patient admitted to hospice. HOPE would be
used to support the standardized collection of the requisite data
elements to calculate quality measures being utilized by the QRP.
Hospices would be required to complete and submit an admission HOPE and
a discharge HOPE collecting a range of status data (set out in the PRA
accompanying this Rule, as well as the HOPE Guidance Manual proposed in
this Rule) for each patient, as well as a HOPE Update Visit assessment,
when applicable, starting October 1, 2025, for FY 2027 APU
determination.
CMS data indicates that approximately 5,640 hospices enroll
approximately 2,763,850 patients in hospice annually.
According to the most recent wage data provided by the Bureau of
Labor Statistics (BLS) for May 2022 (see http://www.bls.gov/oes/current/oes_nat.htm), the median hourly wage for Registered Nurses is
$39.05 and the mean hourly wage for Medical Secretaries is $18.51. With
fringe benefits and overhead, the total per hour rate for Registered
Nurses is $78.10, and the total per hour rate for Medical Secretaries
is $37.02. The foregoing wage figures are outlined in Table 17:
[GRAPHIC] [TIFF OMITTED] TP04AP24.037
The annual time and cost burden for HOPE is calculated by
determining the number of hours spent on each HOPE timepoint and using
an average salary for nurses and medical secretaries to determine the
average cost of the time spent on the assessment.
The total number of Medicare-participating hospices (5,640) and the
total number of admissions per year (2,763,850) are gathered from
claims data collected by CMS. Based on these claims data, we determined
that there are approximately 490 admissions per hospice per year. We
then use data from previous HIS item timings and HOPE beta testing to
determine the average time to complete the three HOPE timepoints. The
time-to-complete is then calculated for each HOPE timepoint for nurses
(clerical staff are assumed to take 5 minutes per timepoint to upload
data). HOPE Admission is estimated to take 27 minutes for a nurse to
complete relative to HIS, the new HOPE HUV is estimated to take 22
minutes for a nurse to complete, and HOPE Discharge is estimated to
take 0 minutes to complete. Together, these burden increases represent
a 54-minute increase per assessment (22 + 27 + 5 = 54 minutes). We also
note that, due to the addition of the HUV timepoint, hospices will
submit an estimated 2,763,850 additional HOPE assessments (one HUV
assessment per admission).
By multiplying the average time-to-complete with the number of
records for a timepoint, we determine the average increase in burden
hours spent for both nurses and clinical staff annually (Admission:
1,243,733 hours, HUV: 1,243,733 hours, Discharge: 0 hours). For
additional information regarding the calculation of HOPE time and cost
burdens, please refer to the HOPE Beta Testing Report found on the HOPE
web page at https://www.cms.gov/medicare/quality/hospice/hope and the
PRA package associated with this rule found at https://www.cms.gov/medicare/regulations-guidance/legislation/paperwork-reduction-act-1995/pra-listing.
To calculate the cost burden, we multiply hospice staff wages by
the amount of time those staff need to spend administering HOPE. We use
the most recent hourly wage data for Registered
[[Page 23827]]
Nurses ($39.05 per hour) and Medical Secretaries ($18.51 per hour) from
the U.S. Bureau of Labor Statistics. These wages are doubled to account
for fringe benefits ($78.10 for Registered Nurses, $37.02 for Medical
Secretaries). Nurse and Medical Secretary wages are then calculated
separately by multiplying time spent on timepoints with the number of
HOPE records with the average wages (for example: 49 clinical minute
increase on HOPE x 490 HOPE records per year/60 minutes x $78.10 =
$31,253.02 nursing wages spent per hospice per year). The calculations
for each of these hospice staff disciplines are added together to
determine the total cost burden increase per hospice.
Based on these calculations, we estimate that our proposal would
therefore result in an incremental increase of 2,487,466-hour annual
burden (1,243,733 hours for HOPE Admissions, 1,243,733 hours for HOPE
Update Visits, and 0 hours for HOPE Discharges) at a cost of
$184,792,739. The total cost burden per hospice ($32,764.67) is
calculated by adding the total clinical cost ($31,253.02, as seen
above) with the total clerical staff cost burden (5 minutes x 490 HOPE
Records per each hospice per year/60 minutes per hour x $37.02 per hour
= $1,511.65). This leads to a cost burden of $184,792,739 across all
hospices ($32,764.67 per hospice x 5,640 hospices). Table 18 below
provides the summary of changes in burden relative to the new HOPE
Admission, Update Visit and Discharge timepoints. This increase in
incremental burden is explained further in the Regulatory Impact
Analysis (RIA) section of this proposed rule, and is also discussed in
detail in the Information Collection Request accompanying this
rulemaking.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP04AP24.038
BILLING CODE 4120-01-C
B. Amendment of HQRP Data Completeness Thresholds
The amended HQRP data completeness thresholds reflect the same
thresholds which have been applied to the HQRP since the FY 2018
Hospice Final Rule as they relate to HIS. As such, this proposal would
not impose any additional collection of information burden on hospices
for the forthcoming Fiscal Year.
V. Response to Comments
Because of the large number of public comments we normally receive
on
[[Page 23828]]
Federal Register documents, we are not able to acknowledge or respond
to them individually. We will consider all comments we receive by the
date and time specified in the DATES section of this preamble, and,
when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
VI. Regulatory Impact Analysis
A. Statement of Need
1. Hospice Payment
This proposed rule meets the requirements of our regulations at
Sec. 418.306(c) and (d), which require annual issuance, in the Federal
Register, of the Hospice Wage Index based on the most current available
CMS hospital wage data, including any changes to the definitions of
CBSAs or previously used Metropolitan Statistical Areas (MSAs), as well
as any changes to the methodology for determining the per diem payment
rates. This proposed rule would update the payment rates for each of
the categories of hospice care, described in Sec. 418.302(b), for FY
2025 as required under section 1814(i)(1)(C)(ii)(VII) of the Act. The
payment rate updates are subject to changes in economy-wide
productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act.
2. Quality Reporting Program
This proposed rule would update the requirements for HQRP to use a
new standardized patient assessment tool, HOPE, which is more
comprehensive than the previous HIS and includes new data elements and
a new time point. These changes would allow HQRP to reflect a more
consistent and holistic view of each patient's hospice election. This
new reporting instrument will collect data that supports current and
newly proposed quality measures included in this proposed rule and
potential future quality measures. The new HOPE data elements are not
only collected by chart abstraction but in real-time to adequately
assess patients based on the hospice's interactions with the patient
and family/caregiver, accommodate patients with varying clinical needs,
and provide additional information to contribute to the patient's care
plan throughout the hospice stay (not just at admission and discharge).
B. Overall Impacts
We have examined the impacts of this proposed rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 14094 on Modernizing Regulatory Review (April 6,
2023), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), the Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96 354), section 1102(b) of the Social
Security Act, section 202 of the Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism
(August 4, 1999), and the Congressional Review Act (CRA) (5 U.S.C.
804(2)).
Executive Orders 12866 (as amended by E.O. 14094) and E.O. 13563
direct agencies to assess all costs and benefits of available
regulatory alternatives and, if regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety effects, distributive
impacts, and equity). Executive Order 14094 amends 3(f) of Executive
Order 12866 to define a ``significant regulatory action'' as an action
that is likely to result in a rulemaking that: (1) has an annual effect
on the economy of $200 million or more in any 1 year, or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or Tribal governments or
communities; (2) creates a serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially alters the budgetary impacts of entitlement grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raise legal or policy issues for which centralized
review would meaningfully further the President's priorities or the
principles set forth in this Executive Order.
A regulatory impact analysis (RIA) must be prepared for a
regulatory action that is significant section 3(f)(1). Based on our
estimates, OMB'S Office of Information and Regulatory Affairs has
determined this rulemaking is significant under section 3(f)(1) of E.O.
12866. Accordingly, we have prepared a regulatory impact analysis
presents the costs and benefits of the rulemaking to the best of our
ability. Pursuant to Subtitle E of the Small Business Regulatory
Enforcement Fairness Act of 1996 (also known as the Congressional
Review Act), OIRA has also determined that this proposed rule meets the
criteria set forth in 5 U.S.C. 804(2).
1. Hospice Payment
We estimate that the aggregate impact of the payment provisions in
this rulemaking would result in an estimated increase of $705 million
in payments to hospices, resulting from the proposed hospice payment
update percentage of 2.6 percent for FY 2025. The impact analysis of
this proposed rule represents the projected effects of the changes in
hospice payments from FY 2024 to FY 2025. Using the most recent
complete data available at the time of rulemaking, in this case FY 2023
hospice claims data as of January 11, 2024, we simulate total payments
using the FY 2024 wage index (pre-floor, pre-reclassified hospital wage
index with the hospice floor, and old OMB delineations with 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 proposed FY 2025 Hospice Wage Index (pre-
floor, pre-reclassified hospital wage index with hospice floor, and the
revised OMB delineations with a 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 payment rates for each level of care by the
proposed FY 2025 wage index and FY 2024 payment rates, we obtain a wage
index standardization factor for each level of care. We apply the wage
index standardization factors so that the aggregate simulated payments
do not increase or decrease due to changes in the wage index.
Certain events may limit the scope or accuracy of our impact
analysis, because such an analysis is susceptible to forecasting errors
due to other changes in the forecasted impact time period. The nature
of the Medicare program is such that the changes may interact, and the
complexity of the interaction of these changes could make it difficult
to predict accurately the full scope of the impact upon hospices.
2. Hospice Quality Reporting Program
As proposed in section III. of this proposed rule, we are requiring
implementation of a hospice patient-level item set to be used by all
hospices to collect and submit standardized data on each patient
admitted to hospice. Based on the cost estimates provided in the
Collection of Information section above, we estimate an annual cost
burden of $184,729,739 across all hospices ($32,764.67 per hospice x
5,640 hospices) starting in FY 2026.
BILLING CODE 4120-01-P
[[Page 23829]]
[GRAPHIC] [TIFF OMITTED] TP04AP24.039
Our proposal would therefore result in a 2,487,466-hour annual
burden (1,243,733 hours for HOPE Admissions, 1,243,733 hours for HOPE
Update Visits, and 0 hours for HOPE Discharges). The total cost burden
per hospice ($32,764.67) is calculated by adding the total nursing cost
with the total clerical staff cost burden. This leads to a cost burden
of $184,792,739 across all hospices ($32,764.67 per hospice x 5,640
hospices). This burden is also discussed in detail as part of an
accompanying PRA submission.
C. Detailed Economic Analysis
1. Proposed Hospice Payment Update for FY 2025
The FY 2025 proposed hospice payment impacts appear in Table 19. We
tabulate the resulting payments according to the classifications (for
example, provider type, geographic region, facility size), and compare
the difference between current and future payments to determine the
overall impact. The first column shows the breakdown of all hospices by
provider type and control (non-profit, for-profit, government, other),
facility location, and facility size. The second column shows the
number of hospices in each of the categories in the first column. The
third column shows the effect of using the FY 2025 updated wage index
data and moving from the old OMB delineations to the new revised OMB
delineations with a 5-percent cap on wage index decreases. The
aggregate impact of the changes in column three is zero percent, due to
the hospice wage index standardization factors. However, there are
distributional effects of using the FY 2025 hospice wage index. The
fourth column shows the effect of the proposed hospice payment update
percentage as mandated by section 1814(i)(1)(C) of the Act and is
consistent for all providers. The proposed hospice payment update
percentage of 2.6 percent is based on the proposed 3.0 percent
inpatient hospital market basket percentage increase reduced by a
proposed 0.4 percentage point productivity adjustment. The fifth column
shows the total effect of the updated wage data and the hospice payment
update percentage on FY 2025 hospice payments. As illustrated in Table
20, the combined effects of all the proposals vary by specific types of
providers and by location. We note that simulated payments are based on
utilization in FY 2023 as seen on Medicare hospice claims (accessed
from the CCW on January 11, 2024) and only include payments related to
the level of care and do not include payments related to the service
intensity add-on.
As illustrated in Table 20, the combined effects of all the
proposals
[[Page 23830]]
vary by specific types of providers and by location.
[GRAPHIC] [TIFF OMITTED] TP04AP24.040
[[Page 23831]]
[GRAPHIC] [TIFF OMITTED] TP04AP24.041
Source: FY 2023 hospice claims data from CCW accessed on January 11,
2024.
Note:The overall total impact reflects the addition of the individual
impacts, which includes the updated wage index data and revised OMB
delineations, as well as the 2.6 percent market basket update.
Due to missing Provider of Services file information (from which hospice
characteristics are obtained), some subcategories in the impact tables
have fewer agencies represented than the overall total (of 6,044).
Subtypes involving ownership only add up to 5,624 while subtypes
involving facility type only add up to 5,621.
Region Key:
New England = Connecticut, Maine, Massachusetts, New Hampshire, Rhode
Island, Vermont
Middle Atlantic = Pennsylvania, New Jersey, New York
South Atlantic = Delaware, District of Columbia, Florida, Georgia,
Maryland, North Carolina, South Carolina, Virginia, West Virginia
East North Central = Illinois, Indiana, Michigan, Ohio, Wisconsin
East South Central = Alabama, Kentucky, Mississippi, Tennessee
West North Central = Iowa, Kansas, Minnesota, Missouri, Nebraska, North
Dakota, South Dakota
West South Central = Arkansas, Louisiana, Oklahoma, Texas
Mountain = Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah,
Wyoming
Pacific= Alaska, California, Hawaii, Oregon, Washington
Outlying = Guam, Puerto Rico, Virgin Islands
[[Page 23832]]
2. Impacts for the Hospice Quality Reporting Program for FY 2025
The HQRP requires the active collection under OMB control number
#0938-1153 (CMS 10390; expiration 01/31/2026) of the Hospice Items Set
(HIS) and CAHPS[supreg] Hospice Survey (OMB control number 0938-1257
(CMS-10537; expiration 07/31/2026). Failure to submit data required
under section 1814(i)(5) of the Act with respect to a CY will result in
the reduction of the annual market basket percentage increase otherwise
applicable to a hospice for that calendar year.
Once adopted, the Federal Government would incur costs related to
the transition from HIS to HOPE. These costs would include provider
training, preparation of HOPE manuals and materials, receipt and
storage of data, data analysis, and upkeep of data submission software.
There are costs associated with the maintenance and upkeep of a CMS-
sponsored web-based program that hospice providers would use to submit
their HOPE data. In addition, the Federal Government would also incur
costs for help-desk support that must be provided to assist hospices
with the data submission process. There would also be costs associated
with the transmission, analysis, processing, and storage of the hospice
data by CMS contractors.
Also, pursuant to section 1814(i)(5)(A)(i) of the Act, hospices
that do not submit the required QRP data would receive a 4 percentage
point reduction of the annual market basket increase. The Federal
Government will incur additional costs associated with aggregation and
analysis of the data necessary to determine provider compliance with
the reporting requirements for any given fiscal year.
The total annual cost to the Federal Government for the
implementation and ongoing management of HOPE data is estimated to be
$1,583,500. As this estimate is the same as the current estimated costs
to the Federal Government associated with HIS, HOPE implementation and
ongoing maintenance would not incur additional annual costs.
The estimated costs to hospice providers associated with HOPE are
calculated as follows:
Part 1. Time Burden
[GRAPHIC] [TIFF OMITTED] TP04AP24.042
[GRAPHIC] [TIFF OMITTED] TP04AP24.043
[[Page 23833]]
[GRAPHIC] [TIFF OMITTED] TP04AP24.044
Part 2. Cost/Wage Calculation
Note that this analysis of HOPE costs presents rounded inputs for
each calculation and based on the incremental increase of burden from
the HIS timepoints. The actual calculations were performed using
unrounded inputs, so the outputs of each equation below may vary
slightly from what would be expected from the rounded inputs.
[GRAPHIC] [TIFF OMITTED] TP04AP24.045
[[Page 23834]]
[GRAPHIC] [TIFF OMITTED] TP04AP24.046
BILLING CODE 4120-01-C
Additional details regarding these costs and calculations are
available in the FY 2025 PRA package.
3. Regulatory Review Cost Estimation
If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this proposed rule, we
should estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that will review this rulemaking, we assume that the total number of
unique commenters on last year's proposed rule will be the number of
reviewers of this proposed rule. We acknowledge that this assumption
may understate or overstate the costs of reviewing this proposed rule.
It is possible that not all commenters reviewed last year's rule in
detail, and it is also possible that some reviewers chose not to
comment on the proposed rule. For these reasons we thought that the
number of past commenters would be a fair estimate of the number of
reviewers of this proposed rule. We welcome any comments on the
approach to estimating the number of entities that will review this
proposed rule. We also recognize that different types of entities are
in many cases affected by mutually exclusive sections of this proposed
rule, and therefore for the purposes of our estimate we assume that
each reviewer reads approximately 50 percent of the rulemaking. We are
soliciting public comments on this assumption.
Using the occupational wage information from the BLS for medical
and health service managers (Code 11-9111) from May 2022; we estimate
that the cost of reviewing this rulemaking is $100.80 per hour,
including overhead and fringe benefits (https://www.bls.gov/oes/current/oes119111.htm). This proposed rule consists of approximately
34,385 words. Assuming an average reading speed of 250 words per
minute, it would take approximately 1 hour for staff to review half of
it. For each hospice that reviews the proposed rule, the estimated cost
is $100.80 (1 hour x $100.80). Therefore, we estimate that the total
cost of reviewing this regulation is $8,064.00 ($100.80 x 80
reviewers).
D. Alternatives Considered
1. Hospice Payment
For the FY 2025 Hospice Wage Index and Rate Update proposed rule,
we considered alternatives to the proposals articulated in section
III.A of this proposed rule. We considered not proposing to adopt the
OMB delineations listed in OMB Bulletin 23-01; however, we have
historically adopted the latest OMB delineations in subsequent
rulemaking after a new OMB Bulletin is released.
Since the hospice payment update percentage is determined based on
statutory requirements, we did not consider alternatives to updating
the hospice payment rates by the payment update percentage. The
proposed 2.6 percent hospice payment update percentage for FY 2025 is
based on a
[[Page 23835]]
proposed 3.0 percent inpatient hospital market basket update for FY
2025, reduced by a proposed 0.4 percentage point productivity
adjustment. Payment rates since FY 2002 have been updated according to
section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update
to the payment rates for subsequent years must be the market basket
percentage increase for that FY. Section 3401(g) of the Affordable Care
Act also mandates that, starting with FY 2013 (and in subsequent
years), the hospice payment update percentage will be annually reduced
by changes in economy-wide productivity as specified in section
1886(b)(3)(B)(xi)(II) of the Act. For FY 2025, since the hospice
payment update percentage is determined based on statutory requirements
at section 1814(i)(1)(C) of the Act, we did not consider alternatives
for the hospice payment update percentage.
2. Hospice Quality Reporting Program
CMS considered proposing the HOPE instrument with more items,
including data collection about the treatment and activities provided
by multiple disciplines (such as medical social workers (MSW) and
chaplains). However, CMS ultimately omitted those additional items, and
is only proposing HOPE with items deemed relevant to current and
planned quality measurement and public reporting activities.
CMS considered proposing that hospices only need to collect HOPE
data during one HUV rather than two. CMS considered changing the data
submission requirement from thirty (30) days to fifteen (15) days.
However, CMS determined that such a change would provide minimal
benefit at this time while also being disruptive to hospice providers
and this was not proposed.
E. Accounting Statement and Table
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wp-content/uploads/2023/11/CircularA-4.pdf), in
Table 22, we have prepared an accounting statement showing the
classification of the expenditures associated with the provisions of
this proposed rule. Table 22 provides our best estimate of the possible
changes in Medicare payments under the hospice benefit as a result of
the policies in this rulemaking. This estimate is based on the data for
6,044 hospices in our impact analysis file, which was constructed using
FY 2023 claims (accessed from the CCW on January 11, 2024). All
expenditures are classified as transfers to hospices. Also, Table 22
also provides the impact costs associated with the Hospice Quality
Reporting Program starting FY 2026.
[GRAPHIC] [TIFF OMITTED] TP04AP24.047
[[Page 23836]]
F. Regulatory Flexibility Act (RFA)
The RFA requires agencies to analyze options for regulatory relief
of small entities if a rulemaking has a significant impact on a
substantial number of small entities. For purposes of the RFA, small
entities include small businesses, nonprofit organizations, and small
jurisdictions. We consider all hospices as small entities as that term
is used in the RFA. The North American Industry Classification System
(NAICS) was adopted in 1997 and is the current standard used by the
Federal statistical agencies related to the U.S. business economy.
There is no NAICS code specific to hospice services. Therefore, we
utilized the NAICS U.S. industry title ``Home Health Care Services''
and corresponding NAICS code 621610 in determining impacts for small
entities. The NAICS code 621610 has a size standard of $19 million.\32\
Table 23 shows the number of firms, revenue, and estimated impact per
home health care service category.
---------------------------------------------------------------------------
\32\ Ibid.
INK ``https://www.sba.gov/sites/sbagov/files/2023-03/
Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023%20%281
%29%20%281%29_0.pdf''https://www.sba.gov/sites/sbagov/files/2023-03/
Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023%20%281
%29%20%281%29_0.pdf.
[GRAPHIC] [TIFF OMITTED] TP04AP24.048
The Department of Health and Human Services' practice in
interpreting the RFA is to consider effects economically
``significant'' only if greater than 5 percent of providers reach a
threshold of 3 to 5 percent or more of total revenue or total costs.
The majority of hospice visits are Medicare paid visits, and therefore
the majority of hospice's revenue consists of Medicare payments. Based
on our analysis, we conclude that the policies proposed in this
rulemaking would result in an estimated total impact of 3 to 5 percent
or more on Medicare revenue for greater than 5 percent of hospices.
Therefore, the Secretary has certified that this hospice proposed rule
would have significant economic impact on a substantial number of small
entities. We estimate that the net impact of the policies in this rule
is 2.6 percent or approximately $705 million in increased revenue to
hospices in FY 2025. The 2.6 percent increase in expenditures when
comparing FY 2024 payments to estimated FY 2025 payments is reflected
in the last column of the first row in Table 19 and is driven solely by
the impact of the hospice payment update percentage reflected in the
fifth column of the impact table. In addition, small hospices would
experience a greater estimated increase (X percent), compared to large
hospices (X percent) due to the proposed updated wage index. Further
detail is presented in Table 19 by hospice type and location.
We estimate that the new impact of the proposed HQRP data
collection requirements would be $32,764.81 per hospice. While small
hospices would be estimated to incur the same data collection impact as
all other hospices, we recognize that the impact value is likely to
represent a larger percentage of small provider costs. HOPE already
minimizes the burden that Information Collection Requests (ICRs) place
on the provider. The type of quality data specified for participation
in the HQRP is already currently collected by hospices as part of their
patient care processes.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a MSA and has fewer
than 100 beds. This rulemaking would only affect hospices. Therefore,
the Secretary has determined that this proposed rule would not have a
significant impact on the operations of a substantial number of small
rural hospitals (see Table 19).
G. Unfunded Mandates Reform Act (UMRA)
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2024, that
[[Page 23837]]
threshold is approximately $183 million. This rulemaking is anticipated
to have an effect on State, local, or Tribal governments, in the
aggregate, or on the private sector of $183 million or more in any 1
year.
H. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. We have reviewed this rulemaking under these criteria of
Executive Order 13132 and have determined that it will not impose
substantial direct costs on State or local governments.
I. Conclusion
We estimate that aggregate payments to hospices in FY 2025 would
increase by $705 million as a result of the proposed hospice payment
update, compared to payments in FY 2024. We estimate that in FY 2025,
hospices in urban areas would experience, on average, a 2.6 percent
increase in estimated payments compared to FY 2024; while hospices in
rural areas would experience, on average, a 2.8 percent increase in
estimated payments compared to FY 2024. Hospices providing services in
the Mountain region would experience the largest estimated increases in
payments of 4.2 percent. Hospices serving patients in areas in the
Pacific regions would experience, on average, the lowest estimated
increase of 0.8 percent in FY 2025 payments.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
Medicaid Services, approved this document on March 20, 2024.
List of Subjects in 42 CFR Part 418
Health facilities, Hospice care, Medicare, Reporting and
recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV, part 418 as
set forth below:
PART 418--HOSPICE CARE
0
1. The authority citation for part 418 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
2. Section 418.22 is amended by revising paragraph (c)(1)(i) to read as
follows:
Sec. 418.22 Certification of terminal illness.
* * * * *
(c) * * *
(1) * * *
(i) The medical director of the hospice, the physician designee (as
defined in Sec. 418.3), or the physician member of the hospice
interdisciplinary group; and
* * * * *
0
3. Section 418.24 is amended by--
0
a. Revising paragraphs (a) and (b)(3);
0
b. Redesignating paragraphs (e) through (h) as paragraphs (f) through
(i), respectively; and
0
c. Adding a new paragraph (e).
The revisions and addition read as follows:
Sec. 418.24 Election of hospice care.
(a) Election statement. An individual who meets the eligibility
requirement of Sec. 418.20 may file an election statement with a
particular hospice. If the individual is physically or mentally
incapacitated, his or her representative (as defined in Sec. 418.3)
may file the election statement.
(b) * * *
(3) Acknowledgement that the individual has been provided
information on the hospice's coverage responsibility and that certain
Medicare services, as set forth in paragraph (g) of this section, are
waived by the election. For Hospice elections beginning on or after
October 1, 2020, this would include providing the individual with
information indicating that services unrelated to the terminal illness
and related conditions are exceptional and unusual and hospice should
be providing virtually all care needed by the individual who has
elected hospice.
* * * * *
(e) Notice of election. The hospice chosen by the eligible
individual (or his or her representative) must file the Notice of
Election (NOE) with its Medicare contractor within 5 calendar days
after the effective date of the election statement.
(1) Consequences of failure to submit a timely notice of election.
When a hospice does not file the required Notice of Election for its
Medicare patients within 5 calendar days after the effective date of
election, Medicare will not cover and pay for days of hospice care from
the effective date of election to the date of filing of the notice of
election. These days are a provider liability, and the provider may not
bill the beneficiary for them.
(2) Exception to the consequences for filing the NOE late. CMS may
waive the consequences of failure to submit a timely-filed NOE
specified in paragraph (e)(1) of this section. CMS will determine if a
circumstance encountered by a hospice is exceptional and qualifies for
waiver of the consequence specified in paragraph (e)(1) of this
section. A hospice must fully document and furnish any requested
documentation to CMS for a determination of exception. An exceptional
circumstance may be due to, but is not limited to, the following:
(i) Fires, floods, earthquakes, or similar unusual events that
inflict extensive damage to the hospice's ability to operate.
(ii) A CMS or Medicare contractor systems issue that is beyond the
control of the hospice.
(iii) A newly Medicare-certified hospice that is notified of that
certification after the Medicare certification date, or which is
awaiting its user ID from its Medicare contractor.
(iv) Other situations determined by CMS to be beyond the control of
the hospice.
0
4. Amend Sec. 418.25 by revising paragraph (a) and paragraph (b)
introductory text to read as follows:
Sec. 418.25 Admission to hospice care.
(a) The hospice admits a patient only on the recommendation of the
medical director (or the physician designee, as defined in Sec. 418.3)
in consultation with, or with input from, the patient's attending
physician (if any).
(b) In reaching a decision to certify that the patient is
terminally ill, the hospice medical director (or the physician
designee, as defined in Sec. 418.3) must consider at least the
following information:
* * * * *
0
5. Section 418.102 is amended by revising paragraph (b) introductory
text and paragraph (c) to read as follows:
Sec. 418.102 Condition of participation: Medical director.
* * * * *
(b) Standard: Initial certification of terminal illness. The
medical director (or physician designee, if the medical director is
unavailable, as defined in Sec. 418.3 of this section) or physician
member of the IDG reviews the clinical information for each hospice
patient and provides written certification that it is anticipated that
the patient's life expectancy is 6 months or less if the illness runs
its normal course. The physician must consider the following when
making this determination:
* * * * *
[[Page 23838]]
(c) Standard: Recertification of the terminal illness. Before each
recertification period for each patient, as described in Sec.
418.21(a), the medical director (or physician designee, if the medical
director is unavailable, as defined in Sec. 418.3 of this section) or
physician member of the IDG must review the patient's clinical
information.
* * * * *
Sec. 418.309 [Amended]
0
6. Section 418.309 is amended in paragraphs (a)(1) and (2) by removing
``2032'' and adding in its place ``2033''.
0
7. Section 418.312 is amended by revising paragraph (b)(1) to read as
follows:
Sec. 418.312 Data submission requirements under the hospice quality
reporting program.
* * * * *
(b) * * *
(1) Hospices are required to complete and submit a standardized set
of items for each patient to capture patient-level data, regardless of
payer or patient age. The standardized set of items must be completed
no less frequently than at admission, the hospice update visit (HUV),
and discharge, as directed in the associated guidance manual and
required by the Hospice Quality Reporting Program. Definitions for
changes in patient condition that warrant updated assessment, as well
as the data elements to be completed for each applicable change in
patient condition, are to be provided in sub-regulatory guidance for
the current standardized hospice instrument.
* * * * *
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-06921 Filed 3-28-24; 4:15 pm]
BILLING CODE 4120-01-P