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Rule2023-16116

Medicare Program; FY 2024 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice Quality Reporting Program Requirements, and Hospice Certifying Physician Provider Enrollment Requirements

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Published

August 2, 2023

Effective

October 1, 2023

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This final rule updates the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2024. This rule discusses the comments received regarding information related to the provision of higher levels of hospice care; spending patterns for non-hospice services provided during the election of the hospice benefit; ownership transparency; equipping patients and caregivers with information to inform hospice selection; and ways to examine health equity under the hospice benefit. This rule also finalizes conforming regulations text changes related to the expiration of the COVID-19 public health emergency. In addition, this rule updates the Hospice Quality Reporting Program; discusses the Hospice Outcomes and Patient Evaluation tool; provides an update on Health Equity and future quality measures; and provides updates on the Consumer Assessment of Healthcare Providers and Systems, Hospice Survey Mode Experiment. This rule also codifies hospice data submission thresholds and discusses updates to hospice survey and enforcement procedures. Additionally, the rule requires hospice certifying physicians to be Medicare-enrolled or to have validly opted-out.

Full Text

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[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Rules and Regulations]
[Pages 51164-51199]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16116]

[[Page 51163]]

Vol. 88

Wednesday,

No. 147

August 2, 2023

Part IV

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 418 and 424

Medicare Program; FY 2024 Hospice Wage Index and Payment Rate Update,
Hospice Conditions of Participation Updates, Hospice Quality Reporting
Program Requirements, and Hospice Certifying Physician Provider
Enrollment Requirements; Final Rule

Federal Register / Vol. 88 , No. 147 / Wednesday, August 2, 2023 /
Rules and Regulations

[[Page 51164]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 418 and 424

[CMS-1787-F]
RIN 0938-AV10

Medicare Program; FY 2024 Hospice Wage Index and Payment Rate
Update, Hospice Conditions of Participation Updates, Hospice Quality
Reporting Program Requirements, and Hospice Certifying Physician
Provider Enrollment Requirements

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

ACTION: Final rule.

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SUMMARY: This final rule updates the hospice wage index, payment rates,
and aggregate cap amount for Fiscal Year (FY) 2024. This rule discusses
the comments received regarding information related to the provision of
higher levels of hospice care; spending patterns for non-hospice
services provided during the election of the hospice benefit; ownership
transparency; equipping patients and caregivers with information to
inform hospice selection; and ways to examine health equity under the
hospice benefit. This rule also finalizes conforming regulations text
changes related to the expiration of the COVID-19 public health
emergency. In addition, this rule updates the Hospice Quality Reporting
Program; discusses the Hospice Outcomes and Patient Evaluation tool;
provides an update on Health Equity and future quality measures; and
provides updates on the Consumer Assessment of Healthcare Providers and
Systems, Hospice Survey Mode Experiment. This rule also codifies
hospice data submission thresholds and discusses updates to hospice
survey and enforcement procedures. Additionally, the rule requires
hospice certifying physicians to be Medicare-enrolled or to have
validly opted-out.

DATES: These regulations are effective on October 1, 2023. The
implementation date for the provider enrollment provisions in this
final rule is May 1, 2024.

FOR FURTHER INFORMATION CONTACT: For general questions about hospice
payment policy, send your inquiry via email to:
<a href="/cdn-cgi/l/email-protection#ddb5b2aeadb4beb8adb2b1b4bea49dbeb0aef3b5b5aef3bab2ab">[email&#160;protected]</a>.
For questions regarding the CAHPS[supreg] Hospice Survey, contact
Lauren Fuentes at (410) 786-2290.
For questions regarding the hospice conditions of participation
(CoPs), contact Mary Rossi-Coajou at (410) 786-6051.
For questions regarding the hospice public reporting, contact
Charles Padgett at (410) 786-2811.
For questions regarding the hospice quality reporting program,
contact Jermama Keys at (410) 786-7778.
For questions regarding hospice certifying physician provider
enrollment, contact Frank Whelan at (410) 786-1302.
For information regarding the hospice special focus program, send
your inquiry via email to <a href="/cdn-cgi/l/email-protection#1243415d554d7a7d61627b717752717f613c7a7a613c757d64">[email&#160;protected]</a>.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose

This final rule updates the hospice wage index, payment rates, and
cap amount for Fiscal Year (FY) 2024 as required under section 1814(i)
of the Social Security Act (the Act). This rule discusses the comments
received regarding information related to the provision of higher
levels of hospice care; spending patterns for non-hospice services
provided during the election of the hospice benefit; ownership
transparency; equipping patients and caregivers with information to
inform hospice selection; and ways to examine health equity under the
hospice benefit and finalizes regulations text changes to align with
the expiration of the COVID-19 public health emergency (PHE). This
final rule also discusses updates to the Hospice Quality Reporting
Program (HQRP) and the further development of the Hospice Outcomes and
Patient Evaluation (HOPE) tool with national beta test analyses; and
discusses updates on Health Equity and future quality measures (QMs).
It also provides updates on the Consumer Assessment of Healthcare
Providers and Systems (CAHPS), Hospice Survey Mode Experiment. This
rule codifies hospice data submission thresholds and discusses updates
to hospice survey and enforcement procedures.
In addition, this final rule finalizes provider enrollment
requirements for certifying physicians for hospice services. This rule
also finalizes text changes to regulations that align with the
expiration of the COVID-19 PHE.

B. Summary of the Major Provisions

In section III.A of this final rule, we discuss the comments
received related to the following: increasing access to higher levels
of hospice care; our analysis of non-hospice spending during a hospice
election; ownership transparency; hospice election decision-making; and
ways to examine health equity under the hospice benefit.
In section III.B of this rule, we finalize the FY 2024 hospice
payment update percentage of 3.1 percent, update the hospice payment
rates and the hospice cap amount for FY 2024 by the hospice payment
update percentage of 3.1 percent. We also discuss the finalized text
changes to the regulations related to the expiration of the COVID-19
PHE.
In section III.C of this final rule, we update the HQRP including
the HOPE tool and update the Health Equity and future quality measures;
update the CAHPS[supreg] Hospice Survey Mode Experiment; and finalize
our proposal to codify the hospice data submission threshold.
In section III.D of this final rule, we update the hospice survey
and enforcement procedures.
Finally, in section III.E of this final rule, we discuss our
requirement that physicians who certify hospice services for Medicare
beneficiaries be enrolled in or validly opted-out of Medicare as a
prerequisite for the payment of the hospice service in question.

C. Summary of Impacts

The overall economic impact of this final rule is estimated to be
$780 million in increased payments to hospices in FY 2024.

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 (Sec. 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,

[[Page 51165]]

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 and
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. Limited, short-term, intermittent, inpatient respite care
(IRC) is also available because of the absence or need for relief of
the family or other caregivers. Additionally, an individual can receive
continuous home care (CHC) during a period of crisis in which an
individual requires continuous care to achieve palliation or management
of acute medical symptoms so that the individual can remain at home.
CHC may be covered for as much as 24 hours a day, and these periods
must be predominantly nursing care, in accordance with the regulations
at Sec. 418.204. A minimum of 8 hours of nursing care or nursing and
aide care must be furnished on a particular day to qualify for the CHC
rate (Sec. 418.302(e)(4)).
Hospices covered by this rule must comply with applicable civil
rights laws, including section 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 patients with disabilities
and patient companions with disabilities, including the provisions of
auxiliary aids and services when necessary for effective
communication.\1\ Further information may be found at: <a href="http://www.hhs.gov/ocr/civilrights">http://www.hhs.gov/ocr/civilrights</a>.
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\1\ Hospices receiving Medicare Part A funds or other federal
financial assistance from the Department are also subject to
additional federal civil rights laws, including the Age
Discrimination Act, and are subject to conscience and religious
freedom laws where applicable.
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Title VI of the Civil Rights Act of 1964 prohibits discrimination
on the basis of race, color or national origin in federally assisted
programs or activities. This includes a requirement 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) (Lau v. Nichols, 414 U.S. 563
(1974)). 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
services and translated materials (45 CFR 92.101(a)(2)).

B. Services Covered by the Medicare Hospice Benefit

Coverage under the Medicare hospice benefit requires that hospice
services must be reasonable and necessary for the palliation and
management of the terminal illness and related conditions. Section
1861(dd)(1) of the Act establishes the services that are to be rendered
by a Medicare-certified hospice program. These covered services
include: nursing care; physical therapy; occupational therapy; speech-
language pathology therapy; medical social services; home health aide
services (called hospice aide services); physician services; homemaker
services; medical supplies (including drugs and 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 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, the 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

[[Page 51166]]

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. While a recent
article in a policy journal \2\ discussed the potential role hospices
could play 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.
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\2\ Nelson, R., Should Medical Aid in Dying Be Part of Hospice
Care? Medscape Nurses. February 26, 2020. <a href="https://www.medscape.com/viewarticle/925769#vp_1">https://www.medscape.com/viewarticle/925769#vp_1</a>.
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The Medicare hospice benefit had 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. <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Regulations-and-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Regulations-and-Notices</a>.
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III. Provisions of the Final Rule

A. Hospice Utilization and Spending Patterns

In the FY 2024 Hospice Wage Index and Rate Update proposed rule (88
FR 20022), CMS provided data analysis on hospice utilization trends
from FY 2013 through FY 2022. The analysis included data on the number
of beneficiaries using the hospice benefit, live discharges, reported
diagnoses on hospice claims, Medicare hospice spending, Parts A, B and
D non-hospice spending during a hospice election, as well as services
used outside of the hospice benefit while a patient is under a hospice
election. The proposed rule solicited comments from the public, hospice
providers, patients, and advocates regarding utilization of, and
barriers to higher levels of hospice care and complex palliative
treatments; our analysis of non-hospice spending during a hospice
election; ownership transparency; and hospice election decision making.
Additionally, we solicited comments on ways to examine health equity
under the hospice benefit. Several commenters thanked CMS for
continuing to incorporate monitoring and data analysis into its
proposed hospice payment rule.
1. Correction to Figure 3 in the FY 2024 Hospice Proposed Rule
In the FY 2024 Hospice Wage Index and Rate Update proposed rule (88
FR 20032), we inadvertently provided incorrect data for Figure 3.
Figure 3--Length of Stay Intervals Distribution for Live Discharges,
FYs 2019 to 2022 is corrected to read as follows:

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[GRAPHIC] [TIFF OMITTED] TR02AU23.077

2. Request for Information (RFI) on Hospice Utilization; Non-Hospice
Spending; Ownership Transparency; and Hospice Election Decision-Making
As we continue to focus on improved access and value within the
hospice benefit, in the FY 2024 Hospice Wage Index and Rate Update
proposed rule (88 FR 20022), we solicited comments from the public,
including hospice providers as well as patients and advocates,
regarding certain notable trends in the analysis that coincide with
hospice misinformation obtained anecdotally from beneficiaries; that
is, information related to the provision of higher levels of hospice
care (specifically, CHC, IRC, and GIP) and procedures (specifically,
chemotherapy/radiation, blood transfusions, or dialysis) administered
for palliation when a patient is under a hospice election. We queried
interested parties on potentially restrictive admission policies for
beneficiaries requiring higher-intensity end-of-life and/or palliative
care, the frequency and modality in which hospices educate themselves
on the distinction between curative and complex palliative treatments,
and the way they communicate this information to patients throughout
the hospice election. We solicited comments specifically on how
hospices address financial risks associated with providing such
services, overcome barriers to providing higher intensity levels of
hospice care and complex palliative treatments, and provide necessary
information to patients and families about coverage, staffing levels,
staff encounters, and utilization of higher levels of care. We asked
for feedback on how CMS can work with hospice providers to ensure
Medicare beneficiaries and their families are aware of the coverage
under the hospice benefit and how we can enhance transparency in
ownership trends for beneficiaries selecting hospice care. More
generally, we solicited comments on how CMS can assist hospices in
better serving vulnerable and underserved populations and address
barriers to access.
In total, we received 39 comments in response to our request for
information on hospice utilization, non-hospice spending, ownership
transparency, and hospice election decision-making. These comments and
our responses are summarized in this section of the rule.
Comment: Commenters expressed general concerns about potential
admission policies that could restrict access to higher cost end-of-
life palliative care and discussed inconsistencies in beneficiary
access to treatments that may be based on specific hospice policy or
disease states. They emphasized the need for definitive instruction and
clear expectations from CMS regarding expectations of hospice providers
in determining curative versus palliative treatment coverage under the
hospice benefit. Respondents stated that in providing this additional
guidance CMS should be mindful of the importance of individual hospice
policies; however, education and clear guidance from CMS is crucial in
avoiding confusion as to what treatments can be provided under the
hospice benefit.
Commenters also identified general challenges that could lead to
barriers to providing higher levels of hospice care, such as limited
bed capacity in skilled nursing facilities, difficulties in obtaining
and maintaining contracts with inpatient facilities, staffing
challenges/volunteer shortages, and restrictive rules on the provision
of GIP and CHC. Recommendations included exploring options for in-home
respite care, extending the duration of inpatient respite care, and
providing CHC during

[[Page 51168]]

the actively dying phase to improve patient care and reduce unnecessary
hospitalizations, as it was noted that current policy guidance is not
clear as to whether it is permissible to provide GIP and/or CHC only
during periods of active crisis or if it could be provided during the
entirety of the ``active dying'' phase.
Commenters also highlighted increased costs associated with
providing complex palliative treatments and higher intensity levels of
hospice care and they stated that these costs may pose financial risks
to hospices when enrolling such patients. Respondents strongly
suggested exploring flexibilities or additional payments
(recommendations included the implementation of a risk adjusted, add-on
and/or outlier payment models) to ensure appropriate payment and timely
hospice admission. Several commenters requested that CMS address the
potential correlation between costs and financial risks associated with
providing complex palliative treatments (that is, chemotherapy/
radiation, blood transfusions or dialysis), stating that the current
bundled per diem payment is not reflective of the increased expenses
associated with higher-cost and outlier patient subgroups.
Commenters emphasized the need for CMS education directed towards
patients and families about transitioning from curative interventions
to palliative interventions at the time of hospice admission.
Specifically, a few commenters suggested that the Patient Notification
of Hospice Non-Covered Items, Services, and Drugs should be provided to
all prospective patients at the time of hospice election or as part of
the care plan. Commenters suggestions also included clarifying coverage
for procedures related to the primary diagnosis and exploring the use
of Advanced Beneficiary Notices (ABNs). Commenters noted that hospice
providers, non-hospice providers, Medicare beneficiaries, and their
families need more information to understand these distinctions and
that hospice providers must share the information with patients at the
time of election and throughout the hospice election. However, to the
contrary, several other interested parties raised concerns about
administrative burden regarding the provision of more information
during a period in which beneficiaries and their families are
overwhelmed and that such education may not serve its intended purpose.
Commenters raised concerns about the growth of non-hospice spending
for beneficiaries who elect hospice, particularly with those hospice
agencies who intentionally focus on long-term, low-cost patients, as
the analysis included in the proposed rule highlighted these spending
patterns. Respondents discussed potential policies beyond prior
authorization and the hospice election statement addendum, to ensure
appropriate coverage of prescription drugs and services related to
terminal illnesses and related conditions for hospice patients. They
suggested the need for additional coordination and communication
between hospices, providers, and Part D plans to streamline the
coverage process and ensure timely access to necessary medications and
services.
Regarding CMS' inquiry on how to increase transparency to promote
informed decision-making when choosing a hospice, respondents
recommended providing public information about hospice staffing levels,
frequency of hospice staff encounters, and utilization of higher levels
of care. They suggested including this information on Medicare's Care
Compare website or other accessible platforms to ensure transparency
and facilitate informed decision-making. They also suggested CMS
improve transparency around ownership trends and provide information
about hospice ownership publicly, as ultimately, this information would
be helpful for beneficiaries seeking to select a hospice for end-of-
life care. Respondents recommended differentiating between nonprofit
and for-profit hospices and examining ownership trends.
Response: We appreciate the comments and suggestions received
regarding hospice utilization, non-hospice spending, ownership
transparency, and hospice election decision-making. We acknowledge
commenters' statements and concerns related to the increase in non-
hospice spending, barriers associated with the provision of GIP, IRC,
CHC and complex palliative procedures (such as chemotherapy/radiation,
blood transfusions, or dialysis) under the hospice election, as well as
the financial risks associated with providing these services.
Regarding the use of CHC during the active dying phase, as
established in 1983 Hospice Care final rule (48 FR 56008) and amended
in the FY 2010 Hospice Wage Index final rule (74 FR 39384), we would
like to remind commenters that a period of crisis is a period in which
a patient requires continuous care, which is predominantly nursing
care, to achieve palliation or management of acute medical symptoms and
thus CHC may be provided only during a period of crisis as necessary to
maintain an individual at home. A patient who is actively dying may or
may not require continuous home care and each patient must be evaluated
to determine the intensity of care needs. If a patient is having a
period of crisis, requires a minimum of 8 hours of nursing, hospice
aide, and/or homemaker care during a 24-hour day, which begins and ends
at midnight, and is actively dying, then continuous home care can be
provided. We continue to encourage hospice visits when the patient is
actively dying, and where the need for greater family and caregivers
support is evident, by reminding readers of the service intensity add-
on (SIA) payment in the last 7 days of life, as finalized in the FY
2016 Hospice Wage Index and Payment Rate Update and Hospice Quality
Reporting Requirements (80 FR 47142).
Overall, the insights and suggestions provided by all respondents
will help inform our policy-making measures and will aid our efforts of
continuous improvements to hospice policies to ensure better access and
quality of care for Medicare beneficiaries. We intend to consider all
comments and suggestions to potentially enhance policy development,
address barriers, and promote transparency under the hospice benefit
for potential future rulemaking.
3. RFI on Health Equity Under the Hospice Benefit
In the FY 2024 Hospice Wage Index and Rate Update proposed rule (88
FR 20022), CMS solicited comments from interested parties on health
equity under the hospice benefit. The proposed rule also solicited
comments from the public, hospice providers, patients, and advocates
regarding how hospices are measuring impact on health equity, barriers
in electing and accessing hospice care, and challenges faced by
hospices in collecting and analyzing information related to social
determinants of health (SDOH). We also solicited comments on what data
should be collected to evaluate health equity, geographical area
indices that can be used to assess disparities in hospice, and how CMS
can collect and share information to help hospices serve vulnerable and
underserved populations and address barriers to access.
We received 20 comments in response to our request for information
on health equity under the hospice benefit. The following is a summary
of these comments:
Comment: Commenters described the various barriers and challenges
in collecting information on SDOH and health equity data, such as
patient resistance, difficulty in appropriately

[[Page 51169]]

recording SDOH using electronic medical records (EMR), lack of
specificity in the Consumer Assessment of Healthcare Providers and
Systems (CAHPS) questionnaires provided to patients' families, and
limited resources for data collection. One commenter suggested that CMS
should change the terminology used from ``health equity'' to
``healthcare equity'' to capture what can be measured in terms of
processes of care or outcomes of care. Commenters also noted their
efforts to employ and recruit diverse staff to better represent and
serve underserved populations, in addition to holding trainings to
address any barriers patients may experience related to SDOH.
Commenters provided recommendations for CMS to consider, such as
developing educational tools about cultural norms to facilitate
discussions about hospice care, and implementing a nationally
recognized, standardized, and required assessment tool with data
elements collecting SDOH data. They suggested examples of SDOH data
that should be collected that included health literacy, race, ethnicity
and language data, sexual orientation and gender identity data, housing
security, air and water pollution, food security, living in heat
islands, and access to health care. One commenter also suggested that
any health equity data elements should be exempt from the Hospice
Quality Reporting Program (HQRP) data completion threshold due to the
sensitivity and potential communication issues present at end of life.
Several commenters also recommended the development of a universal
database accessible across the government to enable programs to
accurately assess the extent of the disparities and barriers existing
today and to measure progress made by hospice in promoting health
equity over time.
Response: We appreciate the comments provided in response to our
request for information regarding health equity under the hospice
benefit. We plan to consider these comments and suggestions for
potential future rulemaking as we explore all opportunities to collect
and measure data impacting health equity, examine barriers in electing
and accessing hospice care, assess disparities in the provision of
care, and improve how CMS can help hospices serve vulnerable and
underserved populations. Public input is very valuable for the
continuing development of CMS' health equity efforts and broader
commitment to health equity; a key pillar of our strategic vision as
further described here, <a href="https://www.cms.gov/files/document/health-equity-fact-sheet.pdf">https://www.cms.gov/files/document/health-equity-fact-sheet.pdf</a>.

B. FY 2024 Hospice Wage Index and Rate Update

1. FY 2024 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. The hospice
wage index utilizes the wage adjustment factors used by the Secretary
for purposes of section 1886(d)(3)(E) of the Act for hospital wage
adjustments. 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 the Metropolitan Statistical Areas (MSAs) 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 March 6, 2020, OMB issued
Bulletin No. 20-01, which provided updates to and superseded OMB
Bulletin No. 18-04 that was issued on September 14, 2018. The
attachments to OMB Bulletin No. 20-01 provided detailed information on
the update to statistical areas since September 14, 2018, and were
based on the application of the 2010 Standards for Delineating
Metropolitan and Micropolitan Statistical Areas to Census Bureau
population estimates for July 1, 2017, and July 1, 2018. For a copy of
this bulletin, we refer readers to the following website: <a href="https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf">https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf</a>. In
OMB Bulletin No. 20-01, OMB announced one new Micropolitan Statistical
Area, one new component of an existing Combined Statistical Area (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.
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. In the FY 2021 Hospice Wage
Index final rule (85 FR 47070), we adopted the revised OMB delineations
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). 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.
For FY 2024, the final hospice wage index is based on the FY 2024
hospital pre-floor, pre-reclassified wage index for hospital cost
reporting periods beginning on or after October 1, 2019 and before
October 1, 2020 (FY 2020 cost report data). The final FY 2024 hospice
wage index does 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 final FY 2024 hospice wage index
includes a 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.
In the FY 2006 Hospice Wage Index final rule (70 FR 45135), we
adopted the policy that, for urban labor markets without a hospital
from which hospital wage index data could be derived, all the core-
based statistical areas (CBSAs) within the state would be used to
calculate a statewide urban average pre-floor, pre-reclassified
hospital wage index value to use as a reasonable proxy for these areas.
For FY 2024, the only CBSA without a hospital from which hospital wage
data can be derived is 25980, Hinesville-Fort Stewart, Georgia

[[Page 51170]]

and the wage index value for Hinesville-Fort Stewart, Georgia is
0.8732.
To address rural areas where there were no hospitals, and thus no
hospital wage data on which to base the calculation of the hospice wage
index, 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 would 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).
Currently, the only rural area without a hospital from which hospital
wage data could be derived is Puerto Rico. However, for rural Puerto
Rico, we would 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 would
continue to use the most recent wage index previously available for
that area. For FY 2024, we proposed to continue using the most recent
pre-floor, pre-reclassified hospital wage index value available for
Puerto Rico, which is 0.4047, subsequently adjusted by the hospice
floor.
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 would 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.
The final hospice wage index applicable for FY 2024 (October 1,
2023 through September 30, 2024) is available on the CMS website at:
<a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index</a>.html.
We received 15 comments on the proposed FY 2024 hospice wage index
from various stakeholders, including hospices and national industry
associations. A summary of these comments and our responses to those
comments are as follows:
Comment: A few commenters expressed concern with the CBSA
designations and wage index values assigned to their geographic areas.
Several commenters representing hospices in Coeur d'Alene, ID stated
that the economy and cost-of-living of Coeur d'Alene, ID is not
reflective of the rest of the Idaho region, but rather is reflective of
the ``Pacific'' region that includes the Spokane, WA CBSA. These
commenters recommended that Coeur d'Alene, ID be reassigned to the
Spokane, WA CBSA and assigned the wage index value of that CBSA.
Another commenter stated that hospices in Montgomery County, MD should
be paid the same as hospices in the Washington, DC area because
Montgomery County, MD has a similar cost of living as Washington, DC
and shares the same labor market when competing for labor. This
commenter recommended that the wage index for the Montgomery County/
Fredrick, MD CBSA be reassigned to the Washington, DC CBSA or be
assigned the highest wage index valuation from among the MSAs
metropolitan divisions for the purpose of hospice Medicare payment for
a time limited period, such as five years, in order to evaluate the
impact on Montgomery County hospices.
Response: We thank the commenters for these recommendations.
However, we have used CBSAs for determining hospice payments since FY
2006 and continue to believe that the OMB's geographic area
delineations represent a useful proxy for differentiating between labor
markets and that the geographic area delineations are appropriate for
use in determining Medicare hospice payments. CBSAs provide a uniform
and consistent basis for determining statistical area delineations,
based on long-standing statistical standards maintained by OMB.
Further, OMB conducts periodic review of the standards to ensure their
continued usefulness and relevance. Additionally, other provider types,
such as Inpatient Prospective Payment System (IPPS) hospitals, home
health agencies (HHAs), skilled nursing facilities (SNFs), inpatient
rehabilitation facilities (IRFs), and dialysis facilities, all use
CBSAs to define their labor market areas. Therefore, we believe it is
important to apply this method consistently among providers. Using the
most current OMB delineations provides an accurate representation of
geographic variation in wage levels; therefore, we do not believe it
would be appropriate to allow hospices in Coeur d'Alene, ID or
Montgomery County, MD to be reassigned into a higher CBSA designation.
However, if OMB redesignates Coeur d'Alene, ID or Montgomery County, MD
into the Spokane, WA or the Washington, DC CBSAs (respectively), we
would propose this change in future rulemaking consistent with our
longstanding approach of adopting OMB statistical area delineations
outlined in the most recent OMB bulletins.
Comment: A few commenters expressed concern that the wage index
values assigned to rural areas negatively impacts rural hospice care.
One commenter stated that hospices that serve rural patients receiving
services in their homes are subject to a trend of reduced wage index
values, creating a continued reduction in their Medicare rates as
compared to the national average. Another commenter recommended that
CMS assign the wage index value based on a hospice's office location
rather than the beneficiary's location. This commenter suggested that
it costs more for their hospice to serve rural areas due to the great
distance they are required to travel despite being paid at only 80
percent of the wage index.
Response: We thank the commenters for their recommendations. We
understand there are variables in providing care that are unique to
both urban and rural areas. For instance, rural hospices note higher
mileage costs between patients, while urban hospices note additional
costs associated with necessary security measures and traffic
congestion. However, these factors do not result in lower hospice wage
index values in rural areas versus urban areas. The hospice wage index
reflects the wages that inpatient hospitals pay in their local
geographic areas. Regarding the recommendation to assign the wage index
value based on the location of the hospice's office, we continue to
believe that is more appropriate to assign the wage index value based
on the site of service (the location of the beneficiary) rather than
the hospice's office location. Therefore, we apply the wage index value
to the labor portion of the hospice payment rate based on the
geographic area in which the beneficiary resides when receiving RHC or
CHC and the

[[Page 51171]]

geographic location of the facility for beneficiaries receiving GIP or
IRC.
Comment: Several commenters recommended more far-reaching revisions
and reforms to the wage index methodology used under Medicare fee-for-
service. These recommendations included: geographic reclassification,
implementing an out-migration adjustment for non-hospital providers
using the post floor- post reclassified IPPS wage index as the basis
for the hospice wage index, and reinstituting the rural floor policy so
that no hospice is paid below the rural floor for their state. Another
commenter recommended CMS explore policies that seek to reduce the
continual wage index disparities between high wage index hospices and
low wage index hospices such as has been done in the hospital space.
Finally, MedPAC recommended that Congress repeal the existing Medicare
wage index statutes, including current exceptions, and require the
Secretary to phase in new Medicare wage index systems for hospitals and
other types of providers that: use all-employer, occupation-level wage
data with different occupation weights for the wage index of each
provider type; reflect local area level differences in wages between
and within metropolitan statistical areas and statewide rural areas;
and smooth wage index differences across adjacent local areas.
Response: We appreciate the commenters' recommendations; however,
these comments are outside the scope of the proposed rule. Any changes
regarding the adjustment of the hospice payments to account for
geographic wage differences, beyond the wage index proposals discussed
in the FY 2024 Hospice Wage Index and Rate Update proposed rule, would
have to go through notice and comment rulemaking. While CMS and other
interested parties, such as MedPAC, have explored potential
alternatives to the current CBSA-based labor market system, no
consensus has been achieved regarding how best to implement a
replacement system. we believe that in the absence of hospice specific
wage data, using the pre-floor, pre-reclassified hospital wage data is
appropriate and reasonable for hospice payments. Additionally, 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 provision and the hospital
rural floor applies only to hospitals, 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, SNF PPS,
IRF PPS, and 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.
Comment: One commenter recommended lowering the permanent 5-percent
cap on wage index decreases to a 3-percent cap to protect hospice
providers who are already operating with negative or razor-thin
operating margins.
Response: We thank the commenter for their recommendation. However,
this is outside the scope of the proposed rule. The policy to apply a
permanent 5-percent cap on wage index decreases was finalized in the FY
2023 hospice final rule (87 FR 45677). Any changes to the permanent cap
policy would have to be proposed and finalized through the rulemaking
process and we have not proposed to make any changes to the cap policy
for the upcoming fiscal year.
Final Decision: We are finalizing our proposal to use the FY 2024
pre-floor, pre-reclassified hospital wage index data as the basis for
the FY 2024 hospice wage index. The wage index applicable for FY 2024
is available on our website at: <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index</a>. The hospice wage
index for FY 2024 is effective October 1, 2023 through September 30,
2024.
2. FY 2024 Hospice Payment Update Percentage
Section 4441(a) of the 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 1 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 through 45208) 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) was published by
BLS as private nonfarm business multifactor productivity. Beginning
with the November 18, 2021 release of productivity data, BLS replaced
the term ``multifactor productivity'' with ``total factor
productivity'' (TFP). BLS noted that this is a change in terminology
only and would not affect the data or methodology. As a result of the
BLS name change, the productivity measure referenced in section
1886(b)(3)(B)(xi)(II) of the Act is now published by BLS as ``private
nonfarm business total factor productivity.'' However, as mentioned,
the data and methods are unchanged. We refer readers to <a href="http://www.bls.gov">http://www.bls.gov</a> for the BLS historical published TFP data. A complete
description of IGI's TFP projection methodology is available on the CMS
website at <a href="https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch">https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch</a>. In addition, in the FY 2022 IPPS final rule (86
FR 45214), we noted that beginning with FY 2022, CMS changed the name
of this adjustment to refer to it as the

[[Page 51172]]

``productivity adjustment'' rather than the ``MFP adjustment''.
In the FY 2024 Hospice Wage Index and Payment Rate Update proposed
rule (88 FR 20039), we proposed to apply a market basket percentage
increase of 3.0 percent for FY 2024 using the most current estimate of
the inpatient hospital market basket (based on IHS Global Inc.'s fourth
quarter 2022 forecast with historical data through the third quarter of
2022). 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 2024 of 3.0 percent is required to be
reduced by a productivity adjustment as mandated by the Affordable Care
Act (estimated in the proposed rule to be 0.2 percentage point for FY
2024). Therefore, the proposed hospice payment update percentage for FY
2024 was 2.8 percent. We stated that if more recent data became
available after the publication of the proposed rule and before the
publication of the final rule (for example, a more recent estimate of
the inpatient hospital market basket update or productivity
adjustment), we would use such data, if appropriate, to determine the
hospice payment update percentage for FY 2024 in the final rule. For
this final rule, based on IHS Global Inc.'s (IGI) second quarter 2023
forecast with historical data through the first quarter of 2023, the
inpatient hospital market basket percentage increase for FY 2024 is 3.3
percent. The forecast of the productivity adjustment for FY 2024 for
this final rule, based on IGI's second quarter 2023 forecast, is 0.2
percent. Therefore, the hospice payment update percentage for FY 2024,
based on more recent data, is 3.1 percent.
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 updating hospice payments
using the methodology outlined and apply the 2018-based IPPS market
basket percentage increase for FY 2024 of 3.3 percent, reduced by the
statutorily required productivity adjustment of 0.2 percentage point
along with the wage index budget neutrality adjustment to update the
payment rates. We are using the FY 2024 hospice wage index, which uses
the FY 2024 pre-floor, pre-reclassified IPPS hospital wage index as its
basis.
In the FY 2022 Hospice Wage Index final rule (86 FR 42532 through
42539), we rebased and revised the labor shares for RHC, CHC, GIP, and
IRC using MCR data for freestanding hospices (CMS Form 1984-14, OMB
Control Number 0938-0758) from 2018. The current labor portion of the
payment rates are: RHC, 66.0 percent; CHC, 75.2 percent; GIP, 63.5
percent; and IRC, 61.0 percent. The non-labor portion is equal to 100
percent minus the labor portion for each level of care. The non-labor
portion of the payment rates are as follows: RHC, 34.0 percent; CHC,
24.8 percent; GIP, 36.5 percent; and IRC, 39.0 percent.
We received 40 comments on the proposed hospice update percentage
of 2.8 percent. A summary of the comments and our responses to those
comments are as follows:
Comment: Two commenters, including MedPAC, expressed support for
the proposed payment update percentage. MedPAC, stated that they
believe the statutorily required market basket payment update for FY
2024 is adequate for hospice payments. The Commission stated that the
March 2023 MedPAC report found that indicators of payment adequacy for
hospices--including beneficiary access to care, quality of care,
provider access to capital, and Medicare payments relative to
providers' costs--are generally positive. In particular, the report
found that 2020 Medicare margins were 14.2 percent and projected 2023
Medicare margins to be around 8 percent.
Response: We thank commenters for their support.
Comment: Many commenters expressed appreciation for the proposed
2.8 percent increase to hospice payment rates, yet also expressed
concern that the proposed update is inadequate. These commenters
highlighted that they have experienced unprecedented wage and
inflationary pressures over the last several years. They stated that
wage costs reflect the majority of expenses and in order to recruit and
retain staff they have had to dramatically increase salary and benefit
costs as well as rely on more contract labor. They also state that
inflation for other goods and services, such as drugs and medical
supplies, have contributed to a significant increase in operating
costs. Some commenters stated that increased transportation costs, like
gasoline prices, have a disproportionate impact on hospice providers,
particularly those serving rural patients.
Response: We appreciate the support for the statutorily required
hospice payment update, and understand commenter concerns; however, as
directed by section 1814(i)(1)(C)(ii)(VII) of the Act, we are required
to update hospice payments by the Inpatient Hospital PPS (IPPS) market
basket percentage increase (as defined in section 1886(b)(3)(B)(iii))
for the fiscal year, adjusted for productivity (as required by section
1814(i)(1)(C)(iv)(I) of the Act). Section 1886(b)(3)(B)(iii) of the Act
defines the market basket percentage increase to be based on an index
of appropriately weighted indicators of changes in wages and prices
which are representative of the mix of goods and services included in
such inpatient hospital services. The 2018-based IPPS market basket is
a fixed-weight, Laspeyres-type index that measures price changes over
time and would not reflect increases in costs associated with changes
in the volume or intensity of input goods and services. As such, the
inpatient hospital market basket percentage increase would reflect the
prospective price pressures described by the commenters during a high
inflation period (such as faster wage growth or higher energy prices)
but might not reflect other factors that could increase costs such as
the quantity of labor used or any shifts between contract and staff
nurses. We note that cost changes (that is, the product of price and
quantities) would only be reflected when a market basket is rebased,
and the base year weights are updated to a more recent time period.
We agree with the commenters that recent higher inflationary trends
have impacted the outlook for price growth over the next several
quarters. At the time of the FY 2024 Hospice proposed rule, based on
IGI's fourth quarter 2022 forecast with historical data through the
third quarter of 2022, the 2018-based inpatient hospital market basket
percentage increase was forecasted to be 3.0 percent for FY 2024
reflecting a 3.9-percent forecasted compensation price increase. As
stated, in the FY 2024 Hospice proposed rule, we proposed that if more
recent data became available, we would use such data, if appropriate,
to derive the final FY 2024 inpatient hospital market basket update for
the final rule. For this final rule, we are using an updated forecast
of the price proxies underlying the market basket that incorporates
more recent historical data and reflects a revised outlook regarding
the U.S. economy, including compensation and inflationary pressures. As
stated previously, based on IGI's second quarter 2023 forecast with
historical data through first quarter 2023, the FY 2024 inpatient
hospital market basket percentage increase is 3.3 percent (reflecting
forecasted compensation price growth of 4.3 percent) and the FY 2024
productivity adjustment is 0.2 percentage point. After consideration of

[[Page 51173]]

the comments received, for FY 2024, the final hospice payment update is
3.1 percent (3.3 percent inpatient hospital market basket percentage
increase less a 0.2 percentage point productivity adjustment), compared
to the proposed hospice payment update for FY 2024 of 2.8 percent.
Comment: Several commenters stated that the IPPS market basket
reflects a 2018 base year and while more recent final data may not yet
be available, it should be clear that providers' cost structures have
changed since 2018. Commenters were also concerned that the lag in the
cost reporting and other structures and/or indexes that are used as
inputs in determining hospice payment in this proposed rule fail to
capture the inflationary pressures that providers must bear to provide
care in real time and request that CMS consider this fact for the final
rule.
Response: The IPPS market basket measures price changes (including
changes in the prices for wages and salaries) over time and would not
reflect increases in costs associated with changes in the volume or
intensity of input goods and services until the market basket is
rebased. We appreciate the commenter's request to rebase the IPPS
market basket more frequently. Section 404 of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173)
states the Secretary shall establish a frequency for revising the cost
weights of the IPPS market basket more frequently than once every 5
years. We established a rebasing frequency of every four years, in part
because the cost weights obtained from the Medicare cost reports do not
indicate much of a change in the weights from year to year. The most
recent rebasing of the IPPS market basket was for the FY 2022 payment
update (86 FR 45194 through 45207) and reflected a base year of 2018
costs. Despite this established frequency, we regularly monitor the
Medicare cost report data to assess whether a rebasing is technically
appropriate, and we will continue to do so in the future. In this
Medicare report we share some preliminary analysis of the Medicare cost
report data for IPPS hospitals for 2021 that became available for this
final rule. For 2021, the IPPS compensation cost weight is estimated to
be about 1 percentage point lower than the 2018-based IPPS market
basket compensation cost weight of 53.0 percent and reflects a combined
decrease in the salary and benefit cost weights that is larger than the
increase in the contract labor cost weight. The major cost categories
that preliminarily show an increase in the cost weight over this period
are pharmaceuticals (proxied by the PPI--Commodity--Special Index--
Pharmaceuticals for human use, prescription) and home office contract
labor compensation costs (which, would be proxied by the ECI for
Professional and Related workers). We plan to review the 2021 Medicare
cost report data in more detail as well as 2022 Medicare cost report
data as soon as complete information is available and evaluate these
data for future rebasing of the IPPS market basket.
Comment: Many commenters stated that the unprecedented magnitude of
the market basket forecast error over 2021 and 2022 warrants special
consideration to avoid significant long-term underfunding of the
hospice benefit and to help address current workforce challenges.
Several commenters noted that in FY 2021 and FY 2022, CMS forecasted
2.4 percent and 2.7 percent cost inflation while the commenters stated
that the actual cost inflation borne by hospice providers was 3.1
percent and 5.7 percent respectively, which the commenters calculated
to be a 3.7 percent payment update error. Commenters requested that CMS
use the special exceptions and adjustments authority to apply a one-
time cumulative retrospective adjustment of 3.7 percent for FYs 2021
and 2022 to ensure that Medicare payments more accurately reflect the
cost of providing hospice care. The commenters highlighted that the law
does not prohibit CMS from adjusting the annual IPPS operating market
basket increase (and by extension, the annual hospice rate increases)
based on later known errors in historical forecasting. Several of the
commenters stated that unlike other healthcare providers, such as
hospitals, hospices have a large percentage (nearly 90 percent) of
their revenues that originate from the Medicare program. They state
that any insufficient payments from Medicare will have a more
significant impact on hospice providers revenue since they do not have
the ability to negotiate higher rates with private insurers.
Response: We thank the commenters for their recommendation.
However, the inpatient hospital market basket percentage increases are
required by law to be set prospectively, which means that the update
relies on a mix of both historical data for part of the period for
which the update is calculated and forecasted data for the remainder.
There is currently no mechanism to adjust for market basket forecast
error in the hospice payment update. Furthermore, beginning in 1989,
the Congress gave hospices their first increase (20 percent) in payment
since 1986 and tied future increases to the annual increase in the
hospital market basket through a provision contained in the Omnibus
Budget Reconciliation Act of 1989. While the projected inpatient
hospital market basket percentage increases for FY 2021 and FY 2022
were underforecast (actual increases less forecasted increases were
positive), this was largely due to unanticipated inflationary and labor
market pressures as the economy emerged from the COVID-19 PHE.
Importantly, the hospital market basket has been used for many years to
update hospice payment rates and an analysis of the forecast error over
a longer period of time shows that the forecast error has been both
positive and negative. For example, the 10-year cumulative forecast
error (excluding FY 2018 when the hospice payment update was
statutorily required to be 1.0 percent) showed a negative forecast
error (that is, forecasted increases were greater than actual
increases), of 0.9 percentage point (2013-2022). In addition, for each
year from 2012 through 2020 (again excluding 2018), the final FY
inpatient hospital market basket percentage increase (implemented in
the final rule) was higher than the actual inpatient hospital market
basket percentage increase once historical data were available; with 7
out of the 8 years having a forecast error greater than 0.5 percentage
point (in absolute terms). Only considering the forecast error for
years when the final inpatient hospital market basket percentage
increase was lower than the actual inpatient hospital market basket
percentage increase does not consider the numerous years that providers
benefited from the forecast error.
Comment: One commenter stated concern about the quality of cost
report data, especially with regard to capturing labor costs. They
specifically recommend that the cost reports be amended to allow for a
greater breakdown of costs for contracted versus hospice-administered
inpatient services to apportion the labor share appropriately.
Additionally, the commenter requested that CMS clarify how frequently
they intend to update the labor shares component moving forward and
clarify the development and methodology around the ``standardization
factor''.
Response: While we did not solicit comments on the quality of cost
report data, we appreciate the commenter's request for future changes
to the hospice cost report and we will consider this comment when
working on any future modifications to the hospice cost report.

[[Page 51174]]

Comment: A few commenters cited the resumption of the sequestration
policy in 2022 as a concern regarding the adequacy of the proposed
payment update percentage.
Response: We note that Medicare sequestration affects all payment
systems and is not unique to the Medicare hospice benefit or the
statutory authority governing the payment rate update. As such,
comments regarding sequestration are outside the scope of this final
rule.
Final Decision: We are finalizing the hospice payment update
percentage of 3.1 percent for FY 2024. Based on IHS Global, Inc.'s more
recent forecast of the inpatient hospital market basket percentage
increase and the productivity adjustment, the hospice payment update
percentage for FY 2024 will be 3.1 percent for hospices that submit the
required quality data and -0.9 percent (FY 2024 hospice payment update
of 3.1 percent minus 4 percentage points) for hospices that do not
submit the required quality data.
3. FY 2024 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 an
SIA payment for RHC when direct patient care is provided by an RN or
social worker during the last 7 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 4 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 a service intensity add-on 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.
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 2024 hospice rate
setting, we are continuing our longstanding policy of using the most
recent data available. Specifically, we are using FY 2022 claims data
for the FY 2024 payment rate updates. In order to calculate the wage
index standardization factor, we simulate total payments using FY 2022
hospice utilization claims data with the FY 2023 wage index (pre-floor,
pre-reclassified hospital wage index with the hospice floor, and the 5-
percent cap on wage index decreases) and FY 2023 payment rates and
compare it to our simulation of total payments using FY 2022
utilization claims data, the FY 2024 hospice wage index (pre-floor,
pre-reclassified hospital wage index with hospice floor, and the 5-
percent cap on wage index decreases) and FY 2023 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 2023 wage index and payment
rates for each level of care by the FY 2024 wage index and FY 2023
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 the Tables 1 and 2.
The FY 2024 RHC rates are shown in Table 1. The FY 2024 payment
rates for CHC, IRC, and GIP are shown in Table 2.
[GRAPHIC] [TIFF OMITTED] TR02AU23.078

[[Page 51175]]

[GRAPHIC] [TIFF OMITTED] TR02AU23.079

Sections 1814(i)(5)(A) through (C) of the Act require that hospices
submit quality data, based 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 HQRP as required by those
sections. Hospices were required to begin collecting quality data in
October 2012 and submit those quality data in 2013. Section
1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014
through FY 2023, the Secretary shall reduce the market basket
percentage increase by 2 percentage points for any hospice that does
not comply with the quality data submission requirements with respect
to that FY. Section 1814(i)(5)(A)(i) of the Act was amended by section
407(b) of Division CC, Title IV of the CAA, 2021 to change the payment
reduction for failing to meet hospice quality reporting requirements
from 2 to 4 percentage points. This policy would apply beginning with
the FY 2024 Annual Payment Update (APU) that is based on CY 2022
quality data. Specifically, the Act requires that, for FY 2014 through
FY 2023, the Secretary shall reduce the market basket percentage
increase by 2 percentage points and beginning with the FY 2024 APU and
for each subsequent year, the Secretary shall reduce the market basket
percentage increase by 4 percentage points for any hospice that does
not comply with the quality data submission requirements for that FY.
The FY 2024 rates for hospices that do not submit the required quality
data would be updated by -0.9 percent, which is the FY 2024 hospice
payment update percentage of 3.1 percent minus 4 percentage points.
These rates are shown in Tables 3 and 4.
[GRAPHIC] [TIFF OMITTED] TR02AU23.080

[[Page 51176]]

[GRAPHIC] [TIFF OMITTED] TR02AU23.081

We did not receive any comments on the proposed FY 2024 hospice
payment rates.
Final Decision: We are finalizing the FY 2024 payment rates in
accordance with statutorily mandated requirements.
4. Hospice Cap Amount for FY 2024
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 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 (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
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 (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. 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, 2031. Therefore, for
accounting years that end after September 30, 2016 and before October
1, 2032, 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, 2023, we are proposing conforming regulation text
changes at Sec. 418.309 to reflect the new language added to section
1814(i)(2)(B) of the Act.
The hospice cap amount for the FY 2024 cap year is $33,494.01,
which is equal to the FY 2023 cap amount ($32,486.92) updated by the FY
2024 hospice payment update percentage of 3.1 percent.
We received a few comments regarding the hospice cap amount. A
summary of these comments and our responses to those comments are as
follows:
Comment: One commenter expressed support for the FY 2024 hospice
cap.
Response: We thank the commenter for their support.
Comment: A few commenters, including MedPAC, opposed an increase to
the hospice cap. One commenter suggested that reducing the hospice cap
level would generate savings to the hospice program and encourage all
providers to focus on enhancing efforts to meet hospice eligibility and
provide care for all beneficiaries. Another commenter stated that there
are data that support that a lower cap results in fewer agencies
exceeding it. This commenter believes that reducing the cap could
decrease hospice spending by a significant amount and recommended that
the cap remain at its current amount $32,486.92 with reconsideration of
the cap being wage-adjusted. MedPAC recommended that the hospice
aggregate cap be wage adjusted and reduced by 20 percent.
Response: We thank the commenters for their recommendations to
improve the hospice cap; however, we are required by law to update the
hospice cap amount from the preceding year by the hospice payment
update percentage, in accordance with section 1814(i)(2)(B)(ii) of the
Act. Therefore, we do not have the statutory authority to reduce the
aggregate cap amount.
Final Decision: We are finalizing the update to the hospice cap
amount for FY 2024 in accordance with statutorily mandated
requirements.
5. Conforming Text Revisions for Telehealth Services
In the FY 2024 Hospice Wage Index and Rate Update proposed rule (88
FR 20041), we proposed to revise the regulations text at Sec.
418.22(a)(4)(ii) in accordance with Division FF, section 4113(f) of the
CAA, 2023, effective January 1, 2024. Additionally, we proposed to
remove Sec. 418.204(d), effective retroactively to May 12, 2023 to
align with the end of the COVID-19 PHE. In the first COVID-19 interim
final rule ``Medicare and Medicaid Programs; Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency'' (85 FR
19230, 19289) (April 6, 2020), we amended the hospice regulations at
Sec. 418.204 on an interim basis to specify that when a patient is
receiving routine home care,

[[Page 51177]]

hospices could provide services via a telecommunications system, if it
is feasible and appropriate to ensure that Medicare patients can
continue receiving services that are reasonable and necessary for the
palliation and management of a patients' terminal illness and related
conditions without jeopardizing the patients' health or the health of
those who are providing such services during the COVID-19 PHE. We
stated that this change was effective for the duration of the COVID-19
PHE. Specifically, we proposed to:
<bullet> Revise Sec. 418.22(a)(4)(ii), which outlines the
certification of terminal illness requirements to add ``or through
December 31, 2024, whichever is later'' after ``During a Public Health
Emergency, as defined in Sec. 400.200 of this chapter.''
<bullet> Revise Sec. 418.204, to remove subsection (d) to
eliminate the use of technology in furnishing services during a PHE.
We received several comments regarding the regulations text
revisions for telehealth services. A summary of these comments and our
responses to those comments are as follows:
Comment: In general commenters appreciated the extension of the
telehealth face-to-face coverage through the end of calendar year 2024.
Commenters highlighted the benefits to patients and families,
particularly in rural areas. Many commenters encouraged CMS to consider
making this a permanent provision. Commenters cited benefits of
continuing telehealth under hospice, such as helping to alleviate
staffing concerns and enhanced streamlining of hospice admission.
Response: We thank commenters for their consideration of the
regulation changes regarding the use of telehealth under the Medicare
hospice benefit and we agree that the use of telehealth benefits
patients and their families, particularly in rural areas. We note that,
at this time, the statute only authorized the Secretary extend this
flexibility through December 31, 2024. Additionally, while we
acknowledge the usefulness of telehealth, we continue to believe that
hospice at its core is a benefit best provided in-person and stress the
importance of in-person services. Currently, we do not have plans to
make this provision permanent, nor do we believe that we have the
statutory authority to do so.
Comment: Some commenters encouraged CMS to develop modifiers or
codes for telehealth services and require reporting on the hospice
claim, similar to what was finalized in the CY 2023 HH PPS final rule,
and to allow that these costs be considered allowable administrative
costs on the hospice agency cost report.
Response: We will take into consideration comments requesting that
supplemental telehealth contact be reported on hospice claims and as
allowable administrative costs; however, upon expiration of the face-
to-face flexibility on December 31, 2024, we would expect telehealth
services be summarily limited to follow-up contact with patients and
would not expect to see the provision of hospice services furnished via
telecommunications systems. As such, the value of claims reporting for
this type of contact is not apparent at this time.
Final Decision: We are finalizing the conforming regulations text
revisions for telehealth as proposed.

C. Updates 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.
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. Specifically, the Act requires that, beginning with
FY 2014 through FY 2023, the Secretary shall reduce the market basket
percentage increase by 2 percentage points and beginning with the FY
2024 APU and for each subsequent year, the Secretary shall reduce the
market basket percentage increase by 4 percentage points for any
hospice that does not comply with the quality data submission
requirements for that FY. This payment penalty increase to 4 percent is
statutorily required; as discussed in the following paragraphs, we
proposed to codify its application 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 inpatient hospital market basket percentage increase being
less than zero percent for a FY and may result in payment rates that
are less than payment rates for the preceding FY. Any reduction based
on failure to comply with the reporting requirements, as required by
section 1814(i)(5)(B) of the Act, would apply only for the specified
year. Typically, about 18 percent of Medicare-certified hospices are
found non-compliant with the HQRP reporting requirements and subject to
the APU payment reduction for a given FY.
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 finalized a policy that claims-based measures
would use 8 quarters of data in order 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 public reporting
because the HIS Comprehensive Assessment Measure is sufficient for
measuring care at admission without the seven individual process
measures. For a detailed discussion of the historical use for measure
selection and removal for the HQRP quality measures, we refer readers
to the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR
47142) and the FY 2019 Hospice Wage Index and Rate Update final rule
(83 FR 38622). 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. We
finalized temporary changes to our public reporting policies based on
the March 27, 2020 memorandum \4\ and provided another tip sheet,
referred to as the ``Third Edition HQRP Public Reporting Tip Sheet'' on
the HQRP Requirements and Best Practices web page.
---------------------------------------------------------------------------

\4\ Exceptions and Extensions for Quality Reporting Requirements
for Acute Care Hospitals, PPS-Exempt Cancer Hospitals, Inpatient
Psychiatric Facilities, Skilled Nursing Facilities, Home Health
Agencies, Hospices, Inpatient Rehabilitation Facilities, Long-Term
Care Hospitals, Ambulatory Surgical Centers, Renal Dialysis
Facilities, and MIPS Eligible Clinicians Affected by COVID-19 are
available at: <a href="https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf">https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf</a>.
---------------------------------------------------------------------------

As finalized in the FY 2022 Hospice Wage Index and Payment Rate
Update final rule (86 FR 42552), public 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) is available on the Care
Compare/Provider

[[Page 51178]]

Data Catalogue (PDC) web pages as of the August 2022 refresh. In the FY
2023 Hospice proposed rule, we did not propose any new quality
measures. However, we provided updates on already-adopted measures.
Table 5 shows current quality measures finalized since the FY 2022
Hospice Wage Index and Payment Rate Update final rule.
[GRAPHIC] [TIFF OMITTED] TR02AU23.082

2. Hospice Outcomes & Patient Evaluation (HOPE) Update
As finalized in the FY 2020 Hospice Wage Index and Payment Rate
Update and Hospice Quality Reporting Requirements final rule (84 FR
38484), we are developing a hospice instrument named Hospice Outcomes &
Patient Evaluation (HOPE). Our primary objectives for HOPE are to
provide quality data for the HQRP requirements through standardized
data collection; and provide additional clinical data that could inform
future payment refinements. To the extent that the instrument utilizes
data already being collected for the Hospice QRP, our statutory
authority for the HOPE instrument derives from section 1814(i)(5)(C) of
the Act. In addition, statutory language at section 1861(aa)(2)(G) of
the Act permits the Secretary to impose ``such other requirements as
the Secretary may find necessary in the interest of the health and
safety of the individuals who are provided care and services.''

[[Page 51179]]

The HOPE tool will be a component of implementing high-quality and
safe hospice care for patients, both in Medicare and non-Medicare. HOPE
would also contribute to the patient's plan of care through providing
patient data ongoing throughout the hospice stay. By providing data
from multiple time points across the hospice stay, HOPE would provide
information to hospice providers to improve practice and care quality.
HOPE is intended to provide quality data to calculate outcomes and
develop additional quality measures.
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
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 rule.
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 data
items and establish the interrater reliability of each item.
We continue HOPE development in accordance with the Blueprint for
the CMS Measures Management System. The development of HOPE is grounded
in information gathering activities to identify and refine hospice
domains and candidate items. We appreciate the industry's and trade
associations' engagement in providing input through information sharing
activities, including listening sessions, expert interviews, key
stakeholder interviews, and focus groups to support HOPE development.
As CMS proceeds with the refinement of HOPE, we will continue to engage
with stakeholders through sub-regulatory channels. We intend to
continue to host HQRP Forums to allow hospices and other interested
parties to engage with us on the latest updates and ask questions on
the development of HOPE and related quality measures as appropriate. We
also have a dedicated email account, <a href="/cdn-cgi/l/email-protection#a4eccbd7d4cdc7c1e5d7d7c1d7d7c9c1cad0e4c7c9d78accccd78ac3cbd2">[email&#160;protected]</a>, for
comments about HOPE. We will use field test results to create a final
version of HOPE to propose in future rulemaking for national
implementation. We will continue to inform all stakeholders throughout
this process by using a variety of sub-regulatory channels and regular
HQRP communication strategies, such as Open-Door Forums (ODF), Medicare
Learning Network (MLN), <a href="http://CMS.gov">CMS.gov</a> website announcements, listserv
messaging, and other ad hoc publicly announced opportunities. We
appreciate the support for HOPE and reiterate our commitment to
providing updates and engaging stakeholders through sub-regulatory
means. HOPE updates can be found at: <a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/HOPE">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/HOPE</a> and engagement opportunities, including those regarding
HOPE are at: <a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-QRP-Provider-Engagement-Opportunities">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-QRP-Provider-Engagement-Opportunities</a>.
We plan to provide additional information regarding HOPE testing
results on the HQRP website in fall of 2023.
Comment: Public comments generally supported development of HOPE.
However, commenters requested more stakeholder engagement and a
generous implementation lead time. Several comments expressed concern
about the potential administrative burden or workflow changes the new
instrument would impose. Some commenters expressed interest in the role
HOPE will play in advancing health equity, including voicing support
for the collection of social risk data, including social determinants
of health (SDOH) data. One commenter recommended that CMS review LCD
guidelines in the context of health equity. One commenter encouraged
CMS to recognize the role of occupational therapists within the IDG
while finalizing HOPE.
Response: We appreciate all stakeholders' input regarding HOPE
development and will take these comments into consideration. We are
committed to developing and implementing HOPE with a minimum burden to
stakeholders. Additional information about HOPE will be presented to
the public as appropriate.
3. Update on Future Quality Measure (QM) Development
In the FY 2020 Hospice Wage Index and Payment Rate Update final
rule (84 FR 38484), we provided updates related to CMS's process for
identifying high priority areas of quality measurement and improvement
and for developing quality measures that address those priorities.
Information on the current HQRP quality measures can be found at:
<a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures</a>.
In this final rule, we provide updates on the status of current
HQRP measures, and the development of hospice quality measure concepts
based on the future use of HOPE, administrative, and health equity
data. On July 26, 2022, the CBE endorsed the claims-based Hospice
Visits in the Last Days of Life measure (HVLDL). More information can
be found on the HQRP Quality Measure Development web page: <a href="https://www.cms.gov/medicare/hospice-quality-reporting-program/quality-measure-development">https://www.cms.gov/medicare/hospice-quality-reporting-program/quality-measure-development</a>. CMS intends to develop several quality measures based on
information collected by HOPE when it is implemented. Currently, CMS
intends to develop at least two HOPE-based process and outcome quality
measures: (1) Timely Reassessment of Pain Impact; and (2) Timely
Reassessment of Non-Pain Symptom Impact. Additional information about
CMS's HOPE-based measure development efforts is available in the 2021
technical expert panel (TEP) Summary Reports and the 2021 Information
Gathering Report, available at: <a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-QRP-Provider-Engagement-Opportunities">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-QRP-Provider-Engagement-Opportunities</a>.
Comment: Commenters were generally supportive of the two HOPE-based
measures currently in development, but also requested additional
information about the measure specifications and more stakeholder
engagement opportunities. One commenter expressed concern about added
regulatory burdens or workflow changes from adopting new quality
measures. Several commenters encouraged CMS to allow reassessments to
be completed telephonically or via remote patient monitoring (RPM), or
to allow any member of the interdisciplinary care team to perform the
assessment. Some commenters suggested reducing the reassessment

[[Page 51180]]

timeframe to one day instead of two, especially if the reassessment
were allowed to be conducted telephonically. Commenters encouraged CMS
to develop outcome measures as well as process measures, and to
incorporate patient preferences into future quality measures.
Response: We appreciate all stakeholders' input regarding quality
measure development and will take these comments into consideration for
future QM development initiatives. We remain committed to building a
robust, evidence-based set of HQRP measures that holistically and
reliably reflect the quality of hospice care.
As development of the HOPE-based quality measures Timely
Reassessment of Pain Impact and Timely Reassessment of Non-Pain Symptom
Impact continues, CMS will keep stakeholders informed of progress and
will offer opportunities for stakeholders to learn more and provide
feedback. We appreciate the input regarding quality measure development
and will take these comments into consideration for future QM
development initiatives. We are committed to the Meaningful Measures
Initiative (<a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy</a>)
and Measures Management System Blueprint (<a href="https://mmshub.cms.gov/blueprint-measure-lifecycle-overview">https://mmshub.cms.gov/blueprint-measure-lifecycle-overview</a>) that informs and guides quality
measure development priorities and processes.
4. Health Equity Updates Related to HQRP
a. Background
In the FY 2023 Hospice Payment Rate Update proposed rule (87 FR
19442), we included a Request for Information (RFI) on hospices'
current health equity activities and a future approach to advancing
health equity in hospice. We define health equity as ``the attainment
of the highest level of health for all people, where everyone has a
fair and just opportunity to attain their optimal health regardless of
race, ethnicity, disability, sexual orientation, gender identity,
socioeconomic status, geography, preferred language, or other factors
that affect access to care and health outcomes.'' We are working to
advance health equity by designing, implementing, and operationalizing
policies and programs that support health for all the people served by
our programs, eliminating avoidable differences in health outcomes
experienced by people who are disadvantaged or underserved, and
providing the care and support that our enrollees need to thrive. CMS'
goals outlined in the CMS Framework for Health Equity 2022-2023 are in
line with Executive Order 13985, ``Advancing Racial Equity and Support
for Underserved Communities Through the Federal Government.'' \5\ The
goals included in the CMS Framework for Health Equity serve to further
advance health equity, expand coverage, and improve health outcomes for
the more than 170 million individuals supported by our programs, and
sets a foundation and priorities for our work, including: strengthening
our infrastructure for assessment, creating synergies across the health
care system to drive structural change, and identifying and working to
eliminate barriers to CMS-supported benefits, services, and coverage.
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\5\ <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/">https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/</a>.
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In addition to the CMS Framework for Health Equity, CMS seeks to
``advance health equity'' as one of eight goals comprising the CMS
National Quality Strategy (NQS).\6\ The NQS identifies a wide range of
potential quality levers that can support our advancement of equity,
including: establishing a standardized approach for patient-reported
data and stratification; employing quality and value-based programs to
publicly report and incentivize closing equity gaps; and developing
equity-focused performance metrics, regulations, oversight strategies,
and quality improvement initiatives.
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\6\ Centers for Medicare & Medicaid Services. What is the CMS
Quality Strategy? Available at: <a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/CMS-Quality-Strategy">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/CMS-Quality-Strategy</a>.
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A goal of this NQS is to address persistent disparities that
underly our healthcare system. Racial disparities, in particular, are
estimated to cost the U.S. $93 billion in excess medical costs and $42B
in lost productivity per year, in addition to economic losses due to
premature deaths.\7\ At the same time, racial and ethnic diversity has
increased in recent years with an increase in the percentage of people
who identify as two or more races accounting for most of the change,
rising from 2.9 percent to 10.2 percent between 2010 and 2020.\8\
Therefore, we need to consider ways to reduce disparities, achieve
equity, and support our diverse population through the way we measure
quality and display of data.
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\7\ Ani Turner, The Business Case for Racial Equity, A Strategy
for Growth, W.K. Kellogg Foundation and Altarum, April 2018.
\8\ 2022 National Healthcare Quality and Disparities Report.
Content last reviewed November 2022. Agency for Healthcare Research
and Quality, Rockville, MD. <a href="https://www.ahrq.gov/research/findings/nhqrdr/nhqdr22/index.html">https://www.ahrq.gov/research/findings/nhqrdr/nhqdr22/index.html</a>.
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We solicited public comments via the aforementioned RFI on a
potential health equity structural composite measure in the Hospice
Quality Reporting Program. We refer readers to the FY 2023 Hospice
Payment Rate Update final rule (87 FR 45669) for a summary of the
public comments and suggestions received in response to the health
equity RFI.
We took these comments into account, and we continue to work to
develop policies, quality measures, and measurement strategies on this
important topic. After considering public comments, CMS decided to
convene a health equity technical expert panel to provide additional
input to inform the development of health equity quality measures. The
work of this technical expert panel is described in detail below.
Home Health and Hospice Health Equity Technical Expert Panel
To support new health equity measure development, the Home Health
and Hospice Health Equity Technical Expert Panel (Home Health & Hospice
HE TEP) was convened by a CMS contractor in Fall 2022. The Home Health
& Hospice HE TEP comprised health equity experts from hospice and home
health settings, specializing in quality assurance, patient advocacy,
clinical work, and measure development. The TEP was charged with
providing input on a potential cross-setting health equity structural
composite measure concept as set forth in the FY 2023 Hospice Payment
Rate Update proposed rule (87 FR 19442) as part of an RFI related to
the HQRP Health Equity Initiative. Specifically, the TEP assessed the
face validity and feasibility of the potential structural measure. The
TEP also provided input on possible confidential feedback report
options to be used for monitoring health equity. TEP members also had
the opportunity to provide ideas for additional health equity measure
concepts or approaches to addressing health equity in hospice and home
health settings.
Broad themes that recurred throughout discussions were community
access and alignment between the community population and the
organization's patient population. A detailed summary of the Home
Health & Hospice HE TEP meetings and final TEP recommendations is
available on the Hospice QRP Health Equity web page: https://
www.cms.gov/medicare/hospice-

[[Page 51181]]

quality-reporting-program/hospice-qrp-health-equity. CMS is taking the
TEP feedback into consideration as we continue to develop health equity
concepts and policies related to HQRP.
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. This
``Universal Foundation'' of quality measure 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 we all come together on
these critical quality areas. 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.
To learn more the impact and next steps of the Universal
Foundation, read the recent publication of `Aligning Quality Measures
Across CMS--the Universal Foundation' in the New England Journal of
Medicine.
b. Anticipated Future State
Possible Future Health Equity Efforts
We are committed to developing approaches to meaningfully
incorporate the advancement of health equity into the HQRP. One
consideration is including social determinants of health into our
quality measures and data stratification. Social determinants of
health--social, economic, environmental, and community conditions--may
have a stronger influence on the population's health and well-being
than services delivered by practitioners and healthcare delivery
organizations.\9\ Given these impacts, measure stratification is
important. Measure stratification helps identify disparities by
calculating quality measure outcomes separately for different
beneficiary populations. By looking at measure results for different
populations separately, CMS and providers can see how care outcomes may
differ between certain patient populations in a way that would not be
apparent from an overall score (that is, a score averaged over all
beneficiaries). This helps CMS to better fulfill our health equity
goals. For example, when certain quality measures from the past two
decades related to healthcare outcomes for children are stratified by
race, ethnicity, and income, they show that important health
disparities have been narrowed, because outcomes for children in the
lowest income households and for Black and Hispanic children improved
faster than outcomes for children in the highest income households or
for White children.\10\ This differential impact would not be apparent
without stratification. This work supports our desire to understand
with providers what can be learned from stratifying our quality
measures by race, ethnicity, and income.
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\9\ 2022 National Healthcare Quality and Disparities Report.
Content last reviewed November 2022. Agency for Healthcare Research
and Quality, Rockville, MD. <a href="https://www.ahrq.gov/research/findings/nhqrdr/nhqdr22/index.html">https://www.ahrq.gov/research/findings/nhqrdr/nhqdr22/index.html</a>.
\10\ 2022 National Healthcare Quality and Disparities Report.
Content last reviewed November 2022. Agency for Healthcare Research
and Quality, Rockville, MD. <a href="https://www.ahrq.gov/research/findings/nhqrdr/nhqdr22/index.html">https://www.ahrq.gov/research/findings/nhqrdr/nhqdr22/index.html</a>.
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As part of our efforts to advance health equity in hospice, we are
taking into consideration the health equity measures used in other
health care provider settings. There are social determinants of health
(SDOH) data items in the standardized patient assessment instruments
used in the post-acute care (PAC) settings, and data items related to
social drivers of health in acute care settings such as the hospital
inpatient quality reporting program. We see value in aligning SDOH data
items across all care settings and might consider adding SDOH data
items used by other care settings into HQRP as we develop future health
equity quality measures under our HQRP statutory authority.\11\ This
would further the NQS to align quality measures across our programs as
part of the Universal Foundation.\12\
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\11\ <a href="https://www.nejm.org/doi/full/10.1056/NEJMp2215539">https://www.nejm.org/doi/full/10.1056/NEJMp2215539</a>,
February 1, 2023.
\12\ <a href="https://www.nejm.org/doi/full/10.1056/NEJMp2215539">https://www.nejm.org/doi/full/10.1056/NEJMp2215539</a>,
February 1, 2023.
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As we move this important work forward, we will continue to take
input from hospice stakeholders into account and monitor the
application of proposed health equity policies across CMS and other HHS
initiatives. The Initial Proposals for Updating OMB's Race and
Ethnicity Statistical Standards, 88 FR 5375, sought public comments
through April 27, 2023. Also, the Office of the National Coordinator
for Health IT (ONC) welcomes input on data classes and data elements
for future versions of the United States Core Data for Interoperability
(USCDI)--a standardized set of health data classes and constituent data
elements for nationwide, interoperable health information exchange.\13\
In addition, while the anticipated health equity efforts that impact
policy changes would proceed through the notice and comment rulemaking
process, other activities would be completed through sub-regulatory
channels and regular communication strategies, such as Open-Door
Forums, Medicare Learning Network, <a href="http://CMS.gov">CMS.gov</a> website announcements,
listserv messaging, and other opportunities.
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\13\ <a href="https://www.healthit.gov/sites/isa/files/2023-01/Draft-USCDI-Version-4-January-2023-Final.pdf">https://www.healthit.gov/sites/isa/files/2023-01/Draft-USCDI-Version-4-January-2023-Final.pdf</a>.
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Comment: Commenters generally encouraged CMS to expand health
equity measurement. However, several commenters encouraged CMS to wait
until HOPE is implemented to better utilize that instrument for health
equity measurement. These commenters expressed concern about
implementing new health equity measures without an established
instrument that could be used to track relevant patient data. Another
commenter suggested that CMS review LCD guidelines for health equity
guidance.
Response: We appreciate all stakeholder feedback received regarding
health equity. These comments will help inform our future efforts to
incorporate health equity and social determinants of health into HQRP.
We will consider the implications of HOPE implementation for ongoing
health equity efforts.
5. CAHPS Hospice Survey Updates
CAHPS Hospice Survey Mode Experiment
In the FY 2023 Hospice Payment Rate Update final rule (87 FR
45669), we provided information on a mode experiment CMS conducted in
2021. The purpose of the experiment was to test:
<bullet> A web-mail mode (email invitation to a web survey, with
mail follow-up to non-responders).
<bullet> A revised survey version, which is shorter and simpler
than the current survey, and includes new questions on topics suggested
by stakeholders.
<bullet> Modifications to survey administration protocols designed
to improve overall response rates, such as a prenotification letter and
extended field period.
Fifty-six large hospices participated in the mode experiment,
representing a range of geographic regions, ownership,

[[Page 51182]]

and past performance on the CAHPS Hospice Survey. A total of 15,515
decedents/caregivers were randomly sampled from these hospices. Sampled
decedents/caregivers were randomly assigned to one of four modes of
administration (mail only, telephone only, mail-telephone, webmail);
mail only cases were randomly assigned to be administered either the
revised or the current survey.
The information received on the CAHPS Hospice Survey Mode
Experiment CMS conducted in 2021, resulted in the following findings:
<bullet> Response rates to the revised survey were 35.1 percent in
mail only mode, 31.5 percent in telephone only mode, 45.3 percent in
mail-telephone, and 39.7 percent in webmail mode.
<bullet> Response rates to web-mail mode were similar to mail only
mode for those without email addresses (35.2 percent vs. 34.4 percent),
but 13 percentage points higher for those with email addresses (49.6
percent vs. 36.7 percent).
<bullet> Response rates to mail-only administration of the revised
and current survey were similar (35.1 percent vs. 34.2 percent).
<bullet> Mailing of a prenotification letter resulted in an
increased response rate of 2.4 percentage points.
<bullet> Extending the field period to 49 days (from the current 42
days) resulted in an increased response rate of 2.5 percentage points
in the mail only mode.
In addition, the following changes were tested as part of the
revised CAHPS Hospice Survey:
<bullet> Removal of one survey item regarding confusing or
contradictory information from the Hospice Team Communication measure.
<bullet> Replacement of the multi-item Getting Hospice Care
Training measure with a new, one-item summary measure.
<bullet> Addition of a new, two-item Care Preferences measure.
<bullet> Simplified wording to component items in the Hospice Team
Communication, Getting Timely Care, and Treating Family Member with
Respect measures.
CMS will use mode experiment results to inform decisions about
potential changes to administration protocols and survey instrument
content. Potential measure changes will be submitted to the Measures
Under Consideration (MUC) process in 2023 and may be proposed in future
rulemaking. We are not finalizing any changes in this rule.
Comment: Commenters overwhelmingly supported implementation of a
web based CAHPS[supreg] Hospice Survey mode. Several commenters also
encouraged CMS to review the CAHPS[supreg] Hospice Survey through an
equity lens, including looking for opportunities to increase response
rates for non-English-speaking families, making the survey available in
more languages, and ensuring that survey questions are culturally
sensitive. Several commenters recommended that CMS shorten or simplify
the survey to make it easier for caregivers to complete. One commenter
asked CMS to provide more clarification to caregivers of patients who
resided in facilities or had recent hospitalizations, as caregivers may
become confused about which survey applies to each care setting. Once
commenter encouraged CMS to collect CAHPS[supreg] Hospice Survey
responses from families and caregivers closer to the time of a
patient's death. Another commenter observed that the CAHPS[supreg]
Hospice Survey is unique, as the individual who completes the survey is
not the patient who received the service and may have different
perceptions of the care provided. One commenter also encouraged CMS to
update Care Compare without explicit suggested updates.
Response: We thank commenters for their interest in the
CAHPS[supreg] Hospice Survey. We appreciate the support of a web-based
mode of survey administration and simpler CAHPS[supreg] Hospice Survey
instrument. If and when a web-based mode is made available as one of
the approved modes of CAHPS Hospice Survey administration, hospices
would continue to have the option to choose among all approved modes
(that is, web-based mode would not be required). Prior to introducing a
revised survey instrument and/or new approved mode of administration,
we will release detailed information regarding proposed changes to
survey instrument content, survey administration protocols, and data
adjustment procedures needed to promote fair comparisons between
hospices selecting different modes of survey administration.
The CAHPS[supreg] Hospice Survey will continue to be completed by
caregivers. The Hospice CAHPS Survey is completed by the primary
caregiver out of respect for the patient receiving end of life care. We
believe it would not be appropriate to have hospice patients fill out a
survey about the care they are receiving at the very end of their life.
We will also consider opportunities to make the CAHPS[supreg] Hospice
Survey easier for caregivers to understand and complete.
We will consider commenters' feedback and suggestions in the
context of ongoing efforts to improve health equity. We also encourage
hospices to consider their patient/caregiver population and work with
their survey vendor to determine the best mode of data collection.
6. Form, Manner, and Timing of Quality 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 is increased from 2 percent to 4
percent beginning with FY 2024. The Act requires that, beginning with
FY 2014 through FY 2023, the Secretary shall reduce the market basket
percentage increase by 2 percentage points and then beginning in FY
2024 and for each subsequent year, the Secretary shall reduce the
market basket percentage increase by 4 percentage points for any
hospice that does not comply with the quality data submission
requirements for that FY. In the FY 2023 Hospice Wage Index and Payment
Rate Update proposed rule (87 FR 19442), we revised our regulations at
Sec. 418.306(b)(2) in accordance with this statutory change (86 FR
42605). We are not proposing any new public reporting proposals in this
rule.
b. Compliance
HQRP Compliance requires understanding three timeframes for both
HIS and CAHPS: (1) The relevant Reporting Year, payment FY and the
Reference Year. The ``Reporting Year'' (HIS)/``Data Collection Year''
(CAHPS). This timeframe is based on the calendar year (CY). It is the
same CY for both HIS and CAHPS. If the CAHPS Data Collection year is CY
2023, then the HIS reporting year is also CY 2023; (2) The APU is
subsequently applied to FY payments based on compliance in the
corresponding Reporting Year/Data Collection Year; and (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). For example, for the CY 2023 data collection year, the Reference
Year, is CY 2022. This means providers seeking a size exemption for
CAHPS in CY 2023 will base it on their

[[Page 51183]]

hospice size in CY 2022. Submission requirements are codified in Sec.
418.312.
For every CY, all Medicare-certified hospices are required to
submit HIS and CAHPS data according to the requirements in Sec.
418.312. Table 6 summarizes the three timeframes. It illustrates how
the CY interacts with the FY payments, covering the CY 2022 through CY
2025 data collection periods and the corresponding APU application from
FY 2024 through FY 2027.
[GRAPHIC] [TIFF OMITTED] TR02AU23.083

As illustrated in Table 7, CY 2022 data submissions compliance
impacts the FY 2024 APU. CY 2023 data submissions compliance impacts
the FY 2025 APU. CY 2024 data submissions compliance impacts FY 2026
APU. This CY data submission impacting FY APU pattern follows for
subsequent years.
c. Submission of Data Requirements
As finalized in the FY 2016 Hospice Wage Index and Payment Rate
Update 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), known.
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. 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 CAHPS Hospice Survey website:
<a href="http://www.hospicecahpssurvey.org">www.hospicecahpssurvey.org</a>. Table 7. HQRP Compliance Checklist
illustrates the APU and timeliness threshold requirements.

[[Page 51184]]

[GRAPHIC] [TIFF OMITTED] TR02AU23.084

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:
<a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Quality-Reporting-Training-Training-and-Education-Library">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Quality-Reporting-Training-Training-and-Education-Library</a>. For more information about
HQRP Requirements, we refer readers to visit the frequently-updated
HQRP website and especially the Best Practice, Education and Training
Library, and Help Desk web pages at: <a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting</a>. We also encourage readers to visit the HQRP web page and
sign-up for the Hospice Quality ListServ to stay informed about HQRP.
d. Codification of HQRP Data Completion Thresholds
As previously noted, we proposed to add a new paragraph (j) to
Sec. 418.312 for data completion thresholds. In the FY 2016 Hospice
Wage Index final rule (80 FR 47192 through 47193), we finalized HQRP
thresholds for completeness of HQRP data submissions. To ensure that
hospices are meeting an acceptable standard for completeness of
submitted data, we finalized the policy that, beginning with the FY
2018 HQRP, hospices must meet or exceed one data submission threshold.
Hospices must meet or exceed a data submission threshold set at 90
percent of all required HIS or successor instrument records within 30
days of the event (that is, patient's admission or discharge).
Under our finalized policy, some assessment data did not obtain a
response and, in those circumstances, are not ``missing'' nor is the
data incomplete. For example, in the case of a patient who does not
have any of the medical conditions in a ``check all that apply''
listing, the absence of a response of a health condition indicates that
the condition is not present, and it would be incorrect to consider the
absence of such data as missing in a threshold determination.
In the FY 2017 Hospice Wage Index proposed rule, we received
comments on our previously finalized policies for form, manner, and
timing of data collection. These public comments were considered and
summarized in the FY 2017 Hospice Wage Index final rule. In the FY 2022
Hospice Wage Index and Payment Rate Update final rule and the FY 2023
Hospice Wage Index and Payment Rate Update final rule, we provided an
HQRP Compliance Checklist, which illustrated additional details about
how the compliance thresholds applied to APUs by FY.
We proposed to, and are finalizing the decision to, codify these
data completeness thresholds at Sec. 418.312(j)(1) for measures data
collected using the HIS or a successor

[[Page 51185]]

instrument. Under this section, we proposed to codify our requirement
that hospices must meet or exceed a data submission threshold set at 90
percent of all required HIS or successor instrument records within 30
days of the event (that is, patient's admission or discharge) and
submit the data through the CMS designated data submission systems.
This threshold would apply to all HIS or successor instrument-based
measures and data elements adopted into HQRP. We are also finalizing
the decision to codify Sec. 418.312(j)(2) that a hospice must meet or
exceed this threshold to avoid receiving a 4-percentage point reduction
to its annual payment update for a given FY as codified at Sec.
418.306(b)(2).
We solicited public comment on our proposal to codify in
regulations text the HQRP data completion thresholds at Sec.
418.312(j) for measures and standardized patient assessment elements
collected using the HIS or successor instrument and compliance
threshold to avoid receiving 4 percentage point reduction as described
under Sec. 418.306(b)(2).
Comment: One commenter supported CMS's proposal to codify the data
submission requirements, but encouraged CMS to amend the requirements
in future rulemaking once HOPE is officially proposed for data
collection. One commenter expressed concern that the proposed data
submission threshold would be overly burdensome for hospices that are
already struggling with technological or other barriers to meeting HQRP
requirements.
Response: We appreciate stakeholders' feedback and engagement
related to HQRP. We are finalizing the data submission thresholds
regulation text at Sec. 418.312(j) as established in prior rulemaking.
We may consider revisions to data collection thresholds when
implementing HOPE in future rulemaking. The 4 percent APU penalty is
established at Sec. 418.306(b)(2).

D. Establishing Hospice Program Survey and Enforcement Procedures Under
the Medicare Program; Provisions Update (CAA, 2021, Section 407)

Division CC, section 407 of the CAA, 2021, amended Part A of Title
XVIII of the Act to add a new section 1822, and amended sections
1864(a) and 1865(b) of the Act, establishing new hospice program survey
and enforcement requirements, required public reporting of survey
information, and a new hospice hotline.
This law (CAA, 2021) requires public reporting of hospice program
surveys conducted by both State Agencies (SAs) and Accrediting
Organizations (AOs), as well as enforcement actions taken as a result
of these surveys on the CMS website in a manner that is prominent,
easily accessible, searchable, and presented in a readily
understandable format. It removes the prohibition at section 1865(b) of
the Act of public disclosure of hospice surveys performed by AOs, and
requires that AOs use the same survey deficiency reports as SAs (Form
CMS-2567, ``Statement of Deficiencies'' or a successor form) to report
survey findings.
The CAA, 2021 also requires hospice programs to measure and reduce
inconsistency in the application of survey results among all hospice
program surveyors, and requires the Secretary to provide comprehensive
training and testing of SA and AO hospice program surveyors, including
training with respect to review of written plans of care. The CAA, 2021
prohibits SA surveyors from surveying hospice programs for which they
have worked in the last 2 years or have a financial interest, requires
hospice program SAs and AOs to use a multidisciplinary team of
individuals for surveys conducted with more than one surveyor to
include at least one RN and provides that each SA must establish a
dedicated toll-free hotline to collect, maintain, and update
information on hospice programs and to receive complaints.
The provisions in the CAA, 2021 also direct the Secretary to create
a Special Focus Program (SFP) for poor-performing hospice programs,
sets out authority for imposing enforcement remedies for noncompliant
hospice programs, and requires the development and implementation of a
range of remedies as well as procedures for appealing determinations
regarding these remedies. These remedies can be imposed instead of, or
in addition to, termination of a hospice programs' participation in the
Medicare program. The remedies include civil money penalties (CMPs),
suspension of all or part of payments, and appointment of temporary
management to oversee operations.
In the CY 2022 Home Health Prospective Payment System (HH PPS)
final rule (86 FR 62240), we addressed provisions related to the
hospice survey enforcement and other activities described in this
section. A summary of the finalized CAA, 2021 provisions can be found
in the CY 2022 HH PPS final rule: <a href="https://www.govinfo.gov/content/pkg/FR-2021-11-09/pdf/2021-23993.pdf">https://www.govinfo.gov/content/pkg/FR-2021-11-09/pdf/2021-23993.pdf</a>. We finalized all the CAA provisions
in CY 2022 rulemaking except for special focus program (SFP). As
outlined in the CY 2022 HH PPS final rule, we stated that we would take
into account comments that we received and work on a revised proposal,
seeking additional collaboration with stakeholders to further develop
the methodology for the SFP since the publication of the CY 2022 HH PPS
final rule.
In the FY 2023 Hospice Wage Index and Payment Rate Update and
Hospice Quality Reporting Requirements (87 FR 45669) final rule, we
affirmed our intention to initiate a hospice special focus program
Technical Expert Panel (TEP) to provide input on the structure and
methodology of the SFP. Public comments received in response to the FY
2023 Hospice Wage Index and Payment Rate Update proposed rule were
generally supportive of CMS's efforts to establish an SFP and to
convene a TEP to provide feedback on the development of the SFP. A TEP
convened by a CMS contractor provided feedback and considerations on
the preliminary SFP concepts, including the development of a
methodology to identify hospice poor-performers, as well as graduation
and termination criteria, and public reporting. A 30-day call for
nominations was held July 14 through August 14, 2022 and nine TEP
members were selected, representing a diverse range of experience and
expertise related to hospice care and quality. Details from the TEP
meetings, including their recommendations, are available in the TEP
summary report \14\ on the CMS website at <a href="https://www.cms.gov/medicare/quality-safety-oversight-certification-compliance/hospice-special-focus-program">https://www.cms.gov/medicare/quality-safety-oversight-certification-compliance/hospice-special-focus-program</a>. The final TEP feedback is publicly available on the CMS
website.
---------------------------------------------------------------------------

\14\ 2022 Technical Expert Panel and Stakeholder Listening
Sessions: Hospice Special Focus Program Summary Report (April 28,
2023).
---------------------------------------------------------------------------

Accordingly, we proposed to implement an SFP in the CY 2024 Home
Health Prospective Payment Update Rate proposed rule, which will be
available on the Home Health Prospective Payment System Regulations and
Notices page of the CMS website: <a href="https://www.federalregister.gov/public-inspection/2023-14044/medicare-program-calendar-year-2024-home-health-prospective-payment-system-rate-update-home-health">https://www.federalregister.gov/public-inspection/2023-14044/medicare-program-calendar-year-2024-home-health-prospective-payment-system-rate-update-home-health</a>.
Comment: Several public comments expressed concerns about the SFP
and asked for further information as CMS designs this program.
Commenters emphasized the need for a standardized survey process and
increased training to better educate surveyors on hospice regulations.
Some commenters

[[Page 51186]]

expressed concern about a quota system being used for the SFP.
Commenters encouraged CMS to focus on problematic and non-compliant
hospices and asked that non-compliant hospices receive an opportunity
to rectify their issues prior to being penalized. One comment simply
noted and appreciated the SFP update.
Response: We appreciate stakeholders' interest and engagement
related to the hospice SFP. We will consider these comments as we
continue to develop the SFP.

E. Hospice Certifying Physician Enrollment

1. Medicare Provider Enrollment
Section 1866(j)(1)(A) of the Act requires the Secretary to
establish a process for the enrollment of providers and suppliers into
the Medicare program. The overarching purpose of the enrollment process
is to help confirm that providers and suppliers furnishing services or
items (or ordering/certifying the provision thereof) to Medicare
beneficiaries meet all applicable federal and state requirements. The
process is, to an extent, a ``gatekeeper'' that prevents unqualified
and potentially fraudulent individuals and entities from entering and
inappropriately billing Medicare. Since 2006, we have undertaken
rulemaking efforts to outline our enrollment procedures. These
regulations are generally codified in 42 CFR part 424, subpart P
(currently Sec. Sec. 424.500 through 424.575 and hereafter
occasionally referenced as subpart P). They address, among other
things, requirements that providers and suppliers must meet to enroll
in Medicare.
As outlined in Sec. 424.510, one requirement is that the provider
or supplier must complete, sign, and submit to its assigned Medicare
Administrative Contractor (MAC) the appropriate enrollment form,
typically the Form CMS-855 (OMB Control No. 0938-0685). The Form CMS-
855, which can be submitted via paper or electronically through the
internet-based Provider Enrollment, Chain, and Ownership System (PECOS)
process (SORN: 09-70-0532), collects important information about the
provider or supplier. Such data includes, but is not limited to,
general identifying information (for example, legal business name),
licensure and/or certification data, and practice locations. After
receiving the provider's or supplier's initial enrollment application,
CMS or the MAC reviews and confirms the information thereon and
determines whether the provider or supplier meets all applicable
Medicare requirements. We believe this screening process has greatly
assisted CMS in executing its responsibility to prevent Medicare fraud,
waste, and abuse.
As previously mentioned, over the years we have issued various
final rules pertaining to provider enrollment. These rules were
intended not only to clarify or strengthen certain components of the
enrollment process but also to enable us to take further action against
providers and suppliers: (1) engaging (or potentially engaging) in
fraudulent or abusive behavior; (2) presenting a risk of harm to
Medicare beneficiaries or the Medicare Trust Funds; or (3) that are
otherwise unqualified to furnish Medicare services or items. Consistent
with this, and for reasons explained in section III.E.2. of this rule,
we proposed to require physicians who certify hospice services for
Medicare beneficiaries (hereafter occasionally referenced as ``hospice
physicians'') to be enrolled in or validly opted-out of Medicare as a
prerequisite for the payment of the hospice service in question.
2. Statutory and Policy Background
Section 6405(a) of the Affordable Care Act (which amended section
1834(a)(11)(B) of the Act) states that the Secretary may require that a
physician ordering durable medical equipment, prosthetics, orthotics,
and supplies (DMEPOS) be enrolled in Medicare for payment for the
DMEPOS item to be made. Section 6405(b) of the Affordable Care Act
(which amended sections 1814(a)(2) and 1835(a)(2) of the Act) contains
a similar provision regarding the certification of a physician (or
certain eligible professionals) for Part A and B home health services.
Section 6405(c) of the Affordable Care Act, meanwhile, authorizes the
Secretary to extend the requirements of sections 6405(a) and (b) to all
other categories of items or services under title XVIII of the Act
(including covered Part D drugs) that are ordered, prescribed, or
referred by a physician or eligible professional enrolled in Medicare
under section 1866(j) of the Act.
Pursuant to this authority, we finalized 42 CFR 424.507(a) and (b)
in an April 27, 2012 final rule titled ``Medicare and Medicaid
Programs; Changes in Provider and Supplier Enrollment, Ordering and
Referring, and Documentation Requirements; and Changes in Provider
Agreements'' (77 FR 25284). Sections 424.507(a) and (b) collectively
state that for payment to be made for ordered imaging services,
clinical laboratory services, DMEPOS items, or home health services,
the service or item must have been ordered or certified by a physician
or, when permitted, an eligible professional who--(1) is enrolled in
Medicare in an approved status; or (2) has a valid opt-out affidavit on
file with a Part A and B MAC. The purpose of Sec. 424.507(a) and (b)
is to confirm that the physicians and eligible professionals who order
or certify the items and services referenced in those paragraphs are
qualified.
We constantly review program integrity trends to determine whether
certain provider and supplier types and services warrant closer
scrutiny from a provider enrollment perspective. During this process,
we have remained ready to propose expansions to Sec. 424.507(a) and
(b) should circumstances warrant. We believe that the latter situation
currently exists with respect to hospices.
The OIG in July 2018 issued a study titled ``Vulnerabilities in the
Medicare Hospice Program Affect Quality Care and Program Integrity''
(OEI-02-16-00570). This report noted that Medicare in 2016 spent about
$16.7 billion for hospice care for 1.4 million beneficiaries, up from
$9.2 billion for fewer than 1 million beneficiaries in 2006.'' \15\ The
report described how some hospice fraud schemes involved paying
recruiters to target beneficiaries who are not eligible for hospice
care; other schemes involved physicians falsely certifying
beneficiaries as terminally ill when they were not.\16\ (Pursuant to 42
CFR 418.20(b), a physician must certify the beneficiary as being
terminally ill for the beneficiary to be eligible to elect hospice
care.) The OIG cited several examples of this behavior, including the
following:
---------------------------------------------------------------------------

\15\ <a href="https://oig.hhs.gov/oei/reports/oei-02-16-00570.pdf">https://oig.hhs.gov/oei/reports/oei-02-16-00570.pdf</a>, p. 1.
\16\ Ibid., 6.
---------------------------------------------------------------------------

<bullet> Two certifying physicians from a California hospice were
convicted of health care fraud for falsely certifying beneficiaries as
terminally ill. The false certifications were part of a wider fraud
scheme that the hospice owner organized. The scheme involved illegal
payments to patient recruiters for bringing in beneficiaries,
establishing fraudulent diagnoses, and altering medical records.\17\
---------------------------------------------------------------------------

\17\ Ibid., p. 7.
---------------------------------------------------------------------------

<bullet> A Mississippi hospice owner used patient recruiters to
solicit beneficiaries who were not eligible for hospice care. These
patients were unaware of their enrollment in hospice care. The owner
submitted fraudulent charges and received more than $1 million from
Medicare.\18\
---------------------------------------------------------------------------

\18\ Ibid.

---------------------------------------------------------------------------

[[Page 51187]]

<bullet> A Minnesota-based hospice chain agreed to pay $18 million
to resolve allegations that it improperly billed Medicare for care
provided to beneficiaries who were ineligible for hospice because they
were not terminally ill. The hospice chain also allegedly discouraged
physicians from discharging ineligible beneficiaries.\19\
---------------------------------------------------------------------------

\19\ Ibid.
---------------------------------------------------------------------------

<bullet> A hospice physician improperly certified a beneficiary who
a hospital determined to be in ``good shape'' only days before as
terminally ill.\20\
---------------------------------------------------------------------------

\20\ Ibid., p. 6.
---------------------------------------------------------------------------

<bullet> A hospice falsely informed a beneficiary that she could
remain on a liver transplant list even if she chose hospice care.
However, she was removed from the transplant list when she elected
hospice care. When the beneficiary learned of this, she ceased hospice
care so she could be reinstated on the transplant list.\21\
---------------------------------------------------------------------------

\21\ Ibid.
---------------------------------------------------------------------------

<bullet> A physician received kickbacks for recruiting
beneficiaries, many of whom were not terminally ill but seeking
opioids.\22\
---------------------------------------------------------------------------

\22\ Ibid., p. 12.
---------------------------------------------------------------------------

More generally, the OIG expressed concern that: (1) beneficiaries
are put at risk when they are inappropriately enrolled in hospice care
because they might be unwittingly forgoing needed treatment; \23\ (2)
``some hospice physicians are not always meeting requirements when
certifying beneficiaries for hospice care;'' \24\ and (3) hospice fraud
schemes are growing.\25\
---------------------------------------------------------------------------

\23\ Ibid., p. 6.
\24\ Ibid., p. 12.
\25\ Ibid.
---------------------------------------------------------------------------

The Government Accountability Office (GAO) in October 2019 issued a
report titled, ``Medicare Hospice Care: Opportunities Exist to
Strengthen CMS Oversight of Hospice Providers'' (GAO-20-10).\26\ The
GAO observed therein that the number of: (1) Medicare hospice
beneficiaries had almost tripled to nearly 1.5 million by FY 2017; and
(2) Medicare hospice providers had doubled.\27\ The GAO stated that in
light of this growth: ``It is imperative that CMS's oversight of the
quality of Medicare hospice care keeps pace with changes so that the
agency can ensure the health and safety of these terminally ill
beneficiaries.'' \28\
---------------------------------------------------------------------------

\26\ <a href="https://www.gao.gov/assets/gao-20-10.pdf">https://www.gao.gov/assets/gao-20-10.pdf</a>.
\27\ Ibid., p. 25.
\28\ Ibid.
---------------------------------------------------------------------------

In light of the foregoing, we believe that expanding Sec.
424.507(a) and (b) to include hospice services could strengthen the
program integrity aspect of physician certifications. The careful
screening that the enrollment process entails would help us determine
whether the physician meets all federal and state requirements (such as
licensure) or presents any program integrity risks, such as past final
adverse actions (as that term is defined in Sec. 424.502). If an
unenrolled physician certifies a Medicare beneficiary's need for
hospice care, we have insufficient background on the physician to know
whether he or she was qualified to do so or has an adverse history. We
believe that some of the aforementioned examples of improper behavior
the OIG found can be at least partially avoided through closer vetting
of the physician. Moreover, the screening process could help foster
beneficiary health and safety by ensuring the physician is
appropriately licensed.
3. Proposed Provisions
Using our authority under section 6405(c) of the Affordable Care
Act, we accordingly proposed the following revisions to Sec. 424.507.
First, the current title of Sec. 424.507(b) states, ``Conditions
for payment of claims for covered home health services''. We proposed
to add ``and hospice'' between ``health'' and ``services'' to account
for our intended inclusion of hospice services within Sec. 424.507(b).
Second, the introductory paragraph of Sec. 424.507(b) reads: ``To
receive payment for covered Part A or Part B home health services, a
provider's home health services claim must meet all of the following
requirements:'' To accommodate hospice services, we proposed to revise
this to state: ``To receive payment for covered Part A or Part B home
health services or for covered hospice services, a provider's home
health or hospice services claim must meet all of the following
requirements:''
Third, the opening language of Sec. 424.507(b)(1) states: ``The
ordering/certifying physician, or the ordering/certifying physician
assistant, nurse practitioner, or clinical nurse specialist working in
accordance with State law . . .''. Under 42 CFR 418.22(b), and as
alluded to previously, only a physician (which can include the
hospice's medical director) can certify that the beneficiary is
terminally ill. We proposed to revise the beginning of Sec.
424.507(b)(1) to state: ``The ordering/certifying physician for hospice
or home health services, or, for home health services, the ordering/
certifying physician assistant, nurse practitioner, or clinical nurse
specialist working in accordance with State law . . .''. This would
help clarify that Sec. 424.507(b)(1) should not be read to imply that
the eligible professionals listed therein can certify the beneficiary's
terminal status.
Fourth, Sec. Sec. 418.22(c)(1)(i) and (ii) state that for the
initial 90-day hospice period, the following physicians, respectively,
must certify that the beneficiary is terminally ill: (1) the hospice's
medical director or the physician member of the hospice
interdisciplinary group (hereafter occasionally referenced collectively
as the ``hospice physician''); and (2) the individual's attending
physician (who must meet the definition of physician in Sec. 410.20)
if the beneficiary has one. For subsequent hospice periods, Sec.
418.22(c)(2) states that only one of the physicians in Sec.
418.22(c)(1)(i) must provide the certification. Given the hospice
program integrity concerns previously mentioned, we believed that each
certification required under Sec. 418.22(c) should be by an enrolled
or validly opted-out physician. Therefore, we proposed to add Sec.
424.507(b)(3) to reflect this requirement and would refer therein to
the requirements of Sec. 418.22(c).
4. Comments Received and Responses
We received approximately 21 pieces of timely correspondence in
response to our proposal. These comments are summarized below. Our
responses are also included.
Comment: Several commenters supported our proposal. One commenter
stated that it could help identify physicians who engage in fraudulent
or abusive behavior that puts Medicare beneficiaries at risk.
Response: We appreciate the commenters' support.
Comment: Several commenters expressed concern about the impact of
requiring the hospice physician to be enrolled. Their concerns fell
into three principal categories. First, they believed that having to
ascertain the physician's enrollment/opt-out status would be
administratively burdensome on hospices, with one commenter stating
that home health agencies (HHAs) have been similarly burdened when
verifying the enrollment/opt-out status of the home health certifying
physician. Second, if the hospice physician is neither enrolled nor
opted-out, the hospice will need to find another hospice physician
(such as the physician member of the hospice interdisciplinary group)
to sign the certification, which could postpone patient care. Third,
various hospices employ or contract with physicians who are neither
enrolled nor opted-out by choice. The commenters believed some of these
physicians would resign or end

[[Page 51188]]

their contract with the hospice rather than enroll or opt-out, hence
requiring the hospice to hire replacement physicians. This could prove
difficult, however, because requiring the hospice physician to be
enrolled or opted-out might limit the pool of prospective physicians,
since some physicians will not wish to seek employment or a contractual
relationship with the hospice if they have to enroll or opt-out.
Especially in rural areas, this could result in further shortages of
hospice physicians, which, in turn, might harm patient care.
Response: We appreciate these comments and address them as follows.
We do not foresee a significant administrative burden associated
with confirming the hospice physician's and attending physician's
enrollment/opt-out statuses. Hospices can quickly verify said status
using the CMS ordering and referring data file (ORDF),\29\ which lists
all Medicare-enrolled and opted-out physicians. HHAs, DMEPOS suppliers,
and suppliers of clinical laboratory and imaging services currently use
this same means of verifying an ordering/certifying/referring
physician's enrollment/opt-out status, and we have not been notified by
these providers and suppliers of any substantial burden associated with
this activity.
---------------------------------------------------------------------------

\29\ <a href="https://data.cms.gov/provider-characteristics/medicare-provider-supplier-enrollment/order-and-referring/data">https://data.cms.gov/provider-characteristics/medicare-provider-supplier-enrollment/order-and-referring/data</a>.
---------------------------------------------------------------------------

Concerning the commenters' second and third assertions, we believe
the situations they cite regarding unenrolled or non-opted out hospice
physicians will be exceedingly rare. We estimated in the ICR section of
the proposed rule that 2,173 certifying physicians would need to enroll
or opt-out in order to certify hospice services. This is a very small
number given the universe of over 2 million physicians nationwide, and
most certifying physicians are already enrolled or opted-out. We are
also confident that the vast preponderance of those who currently are
not will choose to enroll or opt-out, and one commenter, in fact,
agreed with this based on feedback received from the hospice community.
Indeed, this was our experience when we implemented the aforementioned
DMEPOS, HHA, and imaging and clinical laboratory services requirement;
in general, those physicians and practitioners who were neither
enrolled nor opted-out elected to complete the enrollment/opt-out
process in order to continue ordering/certifying/referring the services
and items in question. We believe the same will occur with our hospice
proposal, and we do not expect the physician shortages or postponements
in care that the commenters mentioned to occur.
Comment: A number of commenters opposed our proposed requirement in
new Sec. 424.507(b)(3) to also require the beneficiary's attending
physician to be enrolled/opted-out. Their concerns were generally as
follows.
First, requiring the attending physician's enrollment/opt-out
infringes upon the patient's right to choose their designated attending
physician.
Second, if the attending physician is neither enrolled nor opted-
out, the beneficiary would have to find a new attending physician if
they wish to have one. This could delay the patient's hospice admission
and their consequent ability to receive pain management and palliative
care. The patient may even be too ill to select a new attending
physician or may pass before making their selection. All of this would
place a tremendous and unnecessary burden on the beneficiary and their
family or representative. Commenters stated that these vulnerable
patients in such cases should not have to effectively end their
relationship with the attending physician (who, in many cases, may have
been the patient's primary care physician for years) in order to
receive hospice services.
Third, and in the previous scenario, the hospice, too, would be
burdened. The hospice would have to communicate the attending
physician's non-enrollment/opt-out status to the beneficiary and, in
some cases, assist in finding a new one. Moreover, the hospice may have
received a directive from the designated attending physician to address
immediate patient needs but would have to re-obtain the directive from
a different physician, during which delay the patient may pass.
Fourth, commenters stated that simply requiring the hospice
physician to be enrolled or opted-out should be a sufficient program
integrity safeguard since both the hospice physician and the attending
physician (if the beneficiary has one) must certify the initial hospice
episode. The attending physician can thus further verify the validity
of the hospice physician's certification.
In addition, a commenter contended that since the hospice physician
oversees the beneficiary's plan of care per 42 CFR 418.56(a)(1)(i),
this physician's enrollment or opt-out status alone should serve as an
adequate payment safeguard without the need to require the attending
physician to be enrolled or opted-out.
Response: We appreciate these comments and understand the concerns
expressed. We address them in turn.
First, we do not believe our requirement would infringe upon any
beneficiary right to choose their attending physician. The beneficiary
would not only retain the ability to select a new attending physician
if their chosen one is unenrolled/non-opted out but also need not
choose to have one at all. Furthermore, this attending physician
requirement only applies to the signing of the initial certification.
It does not prohibit the beneficiary's desired attending physician from
treating the beneficiary in the hospice and then billing for these
services under Part B, though we note that in that case the physician
must be enrolled. We therefore respectively disagree that our
requirement restricts the patient's right to select their attending
physician or compels the beneficiary to terminate any relationship
therewith. Our proposal, to reiterate, is strictly limited to the
attending physician's initial certification and does not affect the
larger beneficiary-physician relationship.
Second, and as we previously explained with respect to hospice
physicians, we believe the situation the commenters describe will be
extremely rare. In the overwhelming preponderance of cases, a
beneficiary's attending physician furnishes services to many patients
other than the beneficiary; for instance, many attending physicians
have a private practice that treats numerous patients for matters
unrelated to hospice certifications. This means that the attending
physician is very likely already enrolled/opted-out and hence can sign
the hospice beneficiary's certification. We reemphasize that the number
of unenrolled and non-opted out physicians who certify hospice services
is very small and that, in our view, these physicians would choose to
enroll or opt-out pursuant to our requirement.
Concerning the commenters' third assertion, we again do not
anticipate the excessive burdens on the hospice community (including
compliance with the 2-day period) that the commenters cite given the
very small number of currently unenrolled and non-opted out certifying
physicians.
Finally, we disagree with the commenters' contention that merely
requiring the hospice physician's enrollment/opt-out status should be
adequate to meet CMS' program integrity concerns. To the contrary, our
definition of attending physician in Sec. 418.3 describes the latter
as being identified by the beneficiary, at the time he or she elects to
receive hospice care, as having the most significant role in the

[[Page 51189]]

determination and delivery of the individual's medical care. Given this
relationship, we believe it is particularly important that the
attending physician be properly screened before furnishing the required
certifying statement.
Comment: A commenter asked CMS to clarify that the term ``ordering/
certifying physician'' for purposes of our proposal does not include
the referring/attending physician.
Response: We are finalizing our proposal that attending physicians
must be enrolled or opted-out to certify hospice services. We note,
however, that the term ``ordering'' is largely immaterial for purposes
of the certifications required per Sec. 418.22. That is, in the
context of Sec. 424.507, ``ordering and certifying'' collectively
references all the services and items addressed in Sec. 424.507 that a
physician or practitioner may order or certify. Yet ``ordering'' mostly
pertains to DMEPOS items and clinical laboratory and imaging services,
whereas hospice and home health services involve certification of the
need for said services. As such, the remainder of this section III.E
will simply reference the ``certification'' of hospice services rather
than the ``ordering or certifying'' thereof.
Comment: A commenter sought elucidation on two issues. The first
was whether and how the hospice must document that the attending
physician's enrollment or opt-out status was verified. The second was
how the hospice should proceed if the patient's chosen attending
physician is neither enrolled nor opted-out; the commenter asked
whether the patient in that case is deemed ineligible for hospice care
or the hospice should assign its own attending physician.
Response: Section 424.507(b) does not itself require the
documentation of verification of the attending physician's enrollment/
opt-out status. However, the hospice is ultimately responsible for
confirming this status. Concerning the commenter's second issue, if the
patient designates an attending physician that is neither enrolled nor
opted-out, the certification of terminal illness for the initial 90-day
benefit period would not be valid under Sec. 418.22(c). If the
beneficiary wants to designate a different attending physician, they
may choose to do so. If they elect not to designate an attending
physician, only the hospice certifying physician would certify the
beneficiary's eligibility for the hospice benefit and he or she must be
enrolled or opted-out. This is because the requirement that the hospice
certifying physician and the designated attending physician both must
sign the initial certification only applies if the beneficiary
designates an attending physician. If the beneficiary does not have
one, only the hospice certifying physician must sign the certification.
Comment: Several commenters recommended that CMS delay
implementation of our proposal in order to allow physicians enough time
to enroll or opt-out and for CMS to (1) make system changes and (2)
perform outreach. They stated that hospices, too, will need time to
educate their employed physicians, contracted physicians, and
prospective patients. Suggestions included a 1-year delay.
Response: We agree that a delay in implementation is warranted for
the reasons the commenters outlined. We believe that an additional
seven-months is ample time to ensure certifying hospice and attending
physicians meet all Medicare requirements, given the pressing program
integrity concerns as previously discussed. Further, we believe a May
1, 2024 implementation date strikes a sound balance between addressing
our payment safeguard concerns while giving stakeholders time to
prepare. Accordingly, unenrolled and non-opted out hospice and
attending physicians will have until April 30, 2024 to enroll or opt-
out before the denial of hospice claims commences on May 1, 2024 per
Sec. 424.507(b).
Comment: Several commenters asked whether unenrolled and non-opted-
out physicians can serve as hospice medical directors.
Response: Our provision is restricted to the matter of payment of
hospice Medicare claims and the certifications addressed in Sec.
418.22 in the sole context of provider enrollment. Put otherwise, the
hospice physician, whether the medical director or physician member of
the interdisciplinary group, must be enrolled or opted-out to certify
beneficiary eligibility and for payment to consequently be made.
Comment: Commenters expressed concern that if the patient must
designate a new attending physician because the physician is neither
enrolled nor opted-out, the hospice may be unable to obtain a new
certification from a new attending physician within the required 2-day
timeframe from the effective date of the hospice election period. (Per
Sec. 418.22(a)(3)(i), if the hospice cannot obtain the written
certification required under Sec. 418.22(a)(1) within 2 calendar days
after an election period begins, it must obtain an oral certification
within 2 calendar days and the written certification before it submits
a claim for payment.) Commenters stated that this would negatively
impact the hospice from a financial perspective since payment could be
denied due to a late certification. Additionally, a commenter outlined
a scenario where a patient or representative designates an attending
physician on the election statement who is neither enrolled nor opted-
out; when the hospice realizes that this is the case the patient may
have passed, or the hospice cannot contact the patient's representative
to change the designated attending physician on the election statement.
This commenter further asked whether the hospice must include the
attending physician listed on the election statement on the hospice
claim form in such situations.
Response: As we previously stated, there is a very small number of
currently unenrolled and non-opted-out certifying physicians, so we do
not believe this will be a common issue. Hospices should check the ORDF
to determine the designated attending physician's enrolled/opt-out
status. A good standard of practice would be for the hospice to check
the ORDF in real time at the time the patient or representative is
signing the election statement that includes the designation of an
attending physician, or very shortly thereafter. As outlined in Sec.
418.22, a certification of terminal illness can be completed up to 15
days prior to the start of the election period. Additionally, as
outlined in Sec. 418.24(b)(4), the election statement must include the
effective date of the election, which may be the first day of hospice
care or a later date, but may be no earlier than the date of the
election statement. These flexibilities in our regulations should allow
hospices to ensure that they are complying with the requirement for the
certifying physician(s) to be enrolled or opted-out of Medicare. The
designated attending physician listed on the hospice election statement
must match the information contained in the ``Attending Provider Name
and Identifiers'' field on the institutional claim if the attending
physician is a Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.)
or the ``Other Provider Name and Identifiers'' field on the
institutional claim if the designated attending physician is a nurse
practitioner or physician assistant. To change the designated attending
physician, the patient or representative must sign a statement that
outlines the change in accordance with the regulations at Sec.
418.24(h).
Comment: A commenter asked how CMS would identify when the
attending physician is a physician assistant or nurse practitioner and
waive the claim from enrollment edits.

[[Page 51190]]

Response: An attending physician is defined in Sec. 418.3 as one
of the following:
<bullet> A Doctor of Medicine (M.D.) or osteopathy (D.O.) legally
authorized to practice medicine and surgery by the state in which he or
she performs that function or action;
<bullet> A nurse practitioner who meets the training, education,
and experience requirements as described in Sec. 410.75(b); or
<bullet> A physician assistant who meets the requirements of Sec.
410.74(c).
However, section 1814(a)(7)(A)(i)(I) of the Act does not permit a
nurse practitioner or a physician assistant to certify that the patient
is terminally ill. As outlined in the Medicare Claims Processing
Manual, Section 30.3 of Chapter 11, the ``Attending Provider Name and
Identifiers'' field on the institutional claim form is to contain the
National Provider Identifier (NPI) and name of the attending physician
currently responsible for certifying the terminal illness and signing
the individual's plan of care for medical care and treatment. If the
patient does not have an attending physician that is a D.O. or M.D.,
the hospice would enter the NPI and name of the hospice medical
director or physician member of the interdisciplinary group that
certified that the patient is terminally ill. As outlined in the
Medicare Claims Processing Manual, Section 30.3 of Chapter 11, the
``Other Provider Name and Identifiers'' field on the institutional
claim form is to contain the NPI and name of attending physician if
such attending provider is a nurse practitioner or physician assistant.
In this case, the ``Attending Provider Name and Identifiers'' field
would contain the NPI and name of the hospice medical director or
physician member of the hospice interdisciplinary group that certified
that the patient was terminally ill. When implementing claims
processing edits to check for whether the attending physician (if an
M.D. or D.O.) and hospice physician are enrolled or opted-out of
Medicare, we would do so using PECOS, which can identify whether an NPI
is associated with a nurse practitioner or physician assistant. If the
NPI and name of a nurse practitioner or physician assistant appears in
the ``Other Provider Name and Identifiers'' field on the institutional
claim form, we would not deny the hospice claim if such nurse
practitioner or physician assistant was not enrolled or opted-out of
Medicare.
Comment: A commenter asked how our provision and the rationale for
it relates to or impacts: (1) 42 CFR 405.455(b), which prevents
Medicare Advantage (MA) plans from paying for services rendered by
opted-out physicians; (2) the ``MA Hospice Carve-In''; and (3) the home
health face-to-face requirement (HHFFR) in 42 CFR 424.22.
Response: Our provision is unrelated to MA or the HHFFR. Sections
424.507(a) and (b) only apply to Medicare Part A and Part B and do not
pertain to MA payment. Too, whereas Sec. 405.455(b) addresses services
rendered by opt-out physicians, Sec. 424.507(a) and (b) are restricted
to the ordering/certifying/referring of services or items. As for the
HHFFR, program integrity, like with our proposed provision, was a
consideration in its promulgation. Yet the HHFFR is otherwise unrelated
to the hospice enrollment/opt-out requirement. For instance, while
Sec. 424.507(b) will require enrollment/opt-out status for the hospice
physician and the attending physician, satisfaction of the HHFFR under
Sec. 424.22 does not require the certifying physician or allowed
practitioner (as that latter term is described in Sec. 424.22) to be
enrolled/opted-out.
Comment: A commenter asked whether there are any temporal
limitations on certifications issued by an opted-out physician.
Response: Although we are somewhat unclear as to the commenter's
precise question, we believe the commenter is inquiring whether a
certification signed by a hospice physician or attending physician
under Sec. 418.22 that has opted-out is only valid for a certain
period of time. Our proposal does not change any existing policies in
Sec. 418.22 with respect to the length of time for which a particular
certification remains valid. It only addresses the required enrollment/
opt-out status of the certifying physician and attending physician.
Comment: In a vein akin to the previous comment, several commenters
sought clarification about two issues regarding the duration of the
certification and benefit period. First, they asked whether the hospice
physician and attending physician must be enrolled/opted-out for the
entire benefit period attached to the certification/recertification.
Second, they asked whether, if the certifying physician or attending
physician later becomes unenrolled and non-opted-out, the hospice must
obtain a new certification and, if so, whether this would impact the
benefit period days and any associated face-to-face encounter timing.
Response: The hospice physician and attending physician need only
be enrolled/opted-out at the time they make the certification or
recertification. They need not remain enrolled/opted-out during the
patient's entire certification and benefit period and, if they become
unenrolled and non-opted-out, the hospice need not secure a new
certification to replace the one the previously enrolled/opted-out
physician signed.
Comment: Several commenters asked CMS to clarify that physicians
who complete the Form CMS-855 enrollment application per our proposal
would neither have to list ``Hospice and Palliative Medicine'' as their
specialty designation (specialty code 17) nor specify ``Hospice'' as
among the services they are delivering. They explained that some
attending physicians do not routinely refer patients to hospice and may
not anticipate being designated as a hospice attending physician when
they complete the Medicare enrollment application.
Response: We agree with this comment to the extent it pertains to
an attending physician under our proposal. For hospice physicians,
however, and as with all physicians who complete the Form CMS-855, it
is important that they accurately and truthfully disclose on the
application their primary specialty. If the hospice physician's primary
specialty is indeed hospice/palliative care, this must be reported.
Comment: Several commenters suggested that in lieu of our proposal,
CMS should focus on other means of identifying potentially problematic
hospices, such as: (1) identifying parties that own multiple
independent hospices with different state licenses and National
Provider Identifiers; and (2) hospices that are co-located within the
same physical site. Other commenters stated that measures such as a
moratorium on new hospice licenses in overserved areas and greater
scrutiny of high-risk hospices would be more effective in stopping
problematic hospices than requiring physician enrollment.
Response: We do not believe our efforts to address hospice program
integrity and quality of care concerns need to reflect an ``either/or''
approach, whereby the adoption of one measure mandates the exclusion of
another. There are multiple facets of the hospice arena that are
concerning to us, and our hospice certifying proposal is directly aimed
at ensuring that physicians who certify hospice services are adequately
vetted and are confirmed to meet Medicare requirements. In other words,
this precise concern of ours must be addressed via a specific measure,
and there is no better means of doing so than our proposal.

[[Page 51191]]

Comment: A commenter asked CMS to identify in future rulemaking:
(1) the volume of fraudulent hospice referrals from non-Medicare
enrolled physicians; and (2) outline the administrative burden of this
proposal on hospices and not merely physicians. This would allow
stakeholders to furnish substantive feedback that could help CMS make
informed policy decisions that improve program integrity without
creating unnecessary barriers to services.
Response: We will update the regulatory impact analysis to include
an estimate of the hour and cost burden our provision could have on
hospices. As for the volume of fraudulent hospice certifications from
unenrolled and non-opted-out physicians, our available information is
mostly limited to enrolled parties. Nonetheless, the close scrutiny and
screening the enrollment process furnishes has helped ensure that
Medicare payments are only made to qualified providers and suppliers
and, more pertinently, that DMEPOS, HHA, imaging, and clinical
laboratory items and services are ordered/certified by physicians and
practitioners who meet Medicare requirements. We believe this will be
the case with our hospice provision, too.
Comment: A commenter urged CMS to ensure that hospices can
ascertain a physician's enrollment or opt-out status as easily as
possible. Although, the commenter noted, enrollment data may be
available online, the ability to search such data should be as
intuitive and streamlined as possible to limit burden on hospices.
Response: We agree. We note that the ORDF has given providers and
suppliers a simple, expeditious means of confirming a physician's or
practitioner's enrollment or opt-out status. We will work closely with
the hospice community when implementing this provision and will furnish
education and outreach, particularly regarding the matter of
enrollment/opt-out status verification.
Comment: A commenter stated that our proposed requirement may not
resolve concerns related to inappropriate certification and should be
further considered before implementation to avoid adding barriers to
care. The commenter explained that given the short-stay of many
patients, it is important not to impose administrative steps that could
delay care.
Response: As with all of our provider enrollment regulatory
proposals, we carefully considered our hospice enrollment/opt-out
provision before proposing it and believe it is the best means of
closing the vulnerability of unscreened hospice physicians certifying
hospice services. While we recognize that hospice stays are often
short, we believe that most currently unenrolled/non-opted-out hospice
physicians and attending physicians (both categories of which we
believe, as previously mentioned, are very few) will enroll or opt-out
per our requirements.
Comment: Several commenters did not believe our proposal would
significantly aid in preventing hospice fraudulent behavior because
false certifications will not be identified by the enrollment
verification when claims are processed. They added that many fraudulent
activities that CMS cited in the proposed rule (and highlighted by the
OIG and media reports) involve parties other than physicians; for
instance, the proposed rule identified activities such as paying
recruiters to target ineligible beneficiaries and false certifications
being part of wider fraud schemes orchestrated by hospice owners and
operators, not by individual physicians.
Response: We note two things. One is that the principal purpose of
the enrollment process is to prevent fraud from occurring in the first
place by screening providers and suppliers before they enroll in
Medicare and submit claims. Described otherwise, the aim is not to wait
until claims are submitted to detect fraud but to keep fraudulent
parties from participating in Medicare altogether. This reflects CMS'
desire to avoid a ``pay-and-chase'' approach whereby we pay claims and,
if we find fraud associated with that payment, attempt to recoup the
monies and take action against the provider or supplier. By being
proactive, we can stop such activity before it begins. This is the
objective behind our hospice provision. Carefully screening hospice
physicians and attending physicians (such as for felony convictions,
sanctions, etc.) before they are able to certify Medicare hospice
services will, we believe, significantly reduce the risk that
problematic physicians will furnish false certifications. The second
point is that while some hospice fraud schemes do not directly involve
certifying physicians, some do. Indeed, we previously noted cases where
physicians made false certifications. We also identified several
instances of such conduct in the recently published CY 2024 Home Health
Prospective Payment System proposed rule (88 FR 43654).\30\ We stress
that simply because a certain fraud scheme was devised by the hospice's
owner or manager rather than the hospice physician does not excuse any
participation therein by the latter.
---------------------------------------------------------------------------

\30\ ``Medicare Program; Calendar Year (CY) 2024 Home Health
(HH) Prospective Payment System Rate Update; HH Quality Reporting
Program Requirements; HH Value-Based Purchasing Expanded Model
Requirements; Home Intravenous Immune Globulin Items and Services;
Hospice Informal Dispute Resolution and Special Focus Program
Requirements, Certain Requirements for Durable Medical Equipment
Prosthetics and Orthotics Supplies; and Provider and Supplier
Enrollment Requirements.''
---------------------------------------------------------------------------

Comment: A commenter requested that CMS create an exception to our
requirement when the hospice makes a good-faith effort to determine but
cannot confirm the enrollment status of the certifying or attending
physician. The commenter stated this would prevent unnecessary delays
to hospice election and care.
Response: We respectfully disagree. For reasons already outlined,
we believe it is critical that hospice and attending certifying
physicians be enrolled or opted-out. We also believe the ORDF will
enable hospices to expeditiously ascertain the physician's enrollment/
opt-out status. This has been the general experience of other Medicare
providers and suppliers (such as HHAs) who must verify the enrollment/
opt-out status of physicians and practitioners who order or certify the
services or items referenced in Sec. 424.507.
Comment: Several commenters asked whether CMS will update the ORDF
to include a column for hospices (similar to the existing columns for
DMEPOS and HHAs).
Response: We will update the file to accommodate hospices.
Comment: Commenters recommended that CMS provide education to
physicians and hospices about the enrollment requirements, processes,
list of services, and taxonomy codes relevant to our provision.
Response: CMS will indeed furnish extensive education to the
hospice community and physicians on the matters the commenters'
referenced.
5. Final Provisions
We are finalizing our hospice enrollment provisions as proposed,
though the implementation date for these provisions will be May 1,
2024.

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

[[Page 51192]]

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:
<bullet> The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
<bullet> The accuracy of our estimate of the information collection
burden.
<bullet> The quality, utility, and clarity of the information to be
collected.
<bullet> Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We solicited public comment on each of these issues for the
following sections of this rule that contain information collection
requirements.

A. Hospice Certifying Physician Enrollment

As finalized in section III E. of this rule, physicians who certify
hospice services for Medicare beneficiaries must be enrolled in or
validly opted-out of Medicare as a prerequisite for payment of the
hospice service in question. Most certifying physicians are already
Medicare-enrolled or validly opted-out. Nonetheless, we noted in the
proposed rule that, per CMS data, approximately 2,173 physicians who
certify Medicare hospice services are not. These physicians, as already
stated, would have to enroll or opt-out under our provision. However,
we recently reconsidered this estimate and, based on the latest data,
have determined that there are only 1,382 physicians who would have to
enroll or opt-out pursuant to our requirement. We will use this figure
in our final burden projections.
Strictly for purposes of establishing an estimate, we project that
the average physician will complete a Form CMS-855O enrollment
application (Medicare Enrollment Application--Registration for Eligible
Ordering and Referring Physicians and Non-Physician Practitioners--OMB
Control No.: 0938-1135) rather than an opt-out affidavit to comply with
our requirements. Per previous estimates, it would take approximately
0.5 hours for a physician to complete the Form CMS-855O application.
According to the most recent wage data provided by the Bureau of
Labor Statistics (BLS) for May 2022 (see <a href="http://www.bls.gov/oes/current/oes_nat.htm">http://www.bls.gov/oes/current/oes_nat.htm</a>), the mean hourly wage for the general category of
``Physicians, All Other'' is $114.76. With fringe benefits and
overhead, the total per hour rate is $229.52. The foregoing wage
figures are outlined in Table 8:
[GRAPHIC] [TIFF OMITTED] TR02AU23.085

We project that our provision will therefore result in a 691-hour
burden (1,382 x 0.5 hr) at a cost of $158,598 (691 x $229.52). (Most of
these physicians will enroll during the first year of our provision in
order to continue certifying hospice services.) Averaged over the 3-
year OMB-approval period, this results in annual burdens of 230 hours
and $52,866. This burden will be updated as part of a separate
Paperwork Reduction Act submission.
We received no comments on our proposed ICR estimates and are
finalizing our revised projections as described.

B. Codification of HQRP Data Completeness Thresholds

The codifications to the HQRP data completeness thresholds reflects
the same thresholds which have been applied to the HQRP since the FY
2018 Hospice Final Rule. As such, this rule does not impose any
additional collection of information burden on hospices.

V. Regulatory Impact Analysis

A. Statement of Need

1. Hospice Payment
This final 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 rule updates the payment rates for each of the categories
of hospice care, described in Sec. 418.302(b), for FY 2024 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. Hospice Quality Reporting Program
Sections 1814(i)(5)(A) through (C) of the Act authorizes the HQRP
which requires that hospices submit quality data, based 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
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 update by 2 percentage points for any hospice that does not
comply with the quality data submission requirements with respect to
that FY. Section 1814(i)(5)(A)(i) of the Act was amended by section
407(b) of Division CC, Title IV of the CAA, 2021 to change the payment
reduction for failing to meet hospice quality reporting requirements
from 2 to 4 percentage points. This policy will apply beginning with
the FY 2024 annual payment update (APU) that is based on CY 2022
quality data. Specifically, the Act requires that, for FY 2014 through
FY 2023, the Secretary shall reduce the market basket update by 2
percentage points and beginning with the FY 2024 APU and for each
subsequent year, the Secretary shall reduce the market basket update by
4 percentage points for any hospice that does not comply with the
quality data submission requirements for that FY.
3. Impact of Hospice Ordering/Certifying Physician Enrollment
We proposed that physicians who certify hospice services must be
enrolled in or opted-out of Medicare in order to do so. This proposal
was needed so that CMS could screen the certifying physician to ensure
that they are qualified to certify services (for

[[Page 51193]]

example, licensed, do not have adverse legal actions, etc.). Via this
screening process, we can help protect beneficiaries and the Trust
Funds from unqualified and problematic physicians.

B. Overall Impacts

1. Hospice Payment
We estimate that the aggregate impact of the payment provisions in
this final rule would result in an estimated increase of $780 million
in payments to hospices, resulting from the hospice payment update
percentage of 3.1 percent for FY 2024. The impact analysis of this rule
represents the projected effects of the changes in hospice payments
from FY 2023 to FY 2024. Using the most recent complete data available
at the time of rulemaking, in this case FY 2022 hospice claims data as
of May 11, 2023, we simulate total payments using the FY 2023 wage
index (pre-floor, pre-reclassified hospital wage index with the hospice
floor, and the 5-percent cap on wage index decreases) and FY 2023
payment rates and compare it to our simulation of total payments using
FY 2022 utilization claims data, the FY 2024 hospice wage index (pre-
floor, pre-reclassified hospital wage index with hospice floor, and the
5-percent cap on wage index decreases) and FY 2023 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 2023 wage index and payment
rates for each level of care by the FY 2024 wage index and FY 2023
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.
We have examined the impacts of this 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 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 rule 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) raising legal or policy
issues for which centralized review would meaningfully further the
President's priorities or the principles set forth in this Executive
Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with significant regulatory action/s and/or with significant effects as
per section 3(f)(1) of $200 million or more in any 1 year. Based on our
estimates, OMB'S Office of Information and Regulatory Affairs has
determined this rulemaking 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.

C. Detailed Economic Analysis

1. Hospice Payment Update for FY 2024
The FY 2024 hospice payment impacts appear in Table 9. 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, 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 2024 updated wage index data
with a 5-percent cap on wage index decreases. This represents the
effect of moving from the FY 2023 hospice wage index to the FY 2024
hospice wage index. The aggregate impact of the changes in column three
is zero percent, due to the hospice wage index standardization factor.
However, there are distributional effects of the FY 2024 hospice wage
index. The fourth column shows the effect of the hospice payment update
percentage as mandated by section 1814(i)(1)(C) of the Act and is
consistent for all providers. The hospice payment update percentage of
3.1 percent is based on the 3.3 percent inpatient hospital market
basket percentage increase, reduced by a 0.2 percentage point
productivity adjustment. The fifth column shows the total effect of the
updated wage data and the hospice payment update percentage on FY 2024
hospice payments but does not include the effect of moving from the 2
percent reduction to the 4 percent reduction for failure to report
quality data. It is projected aggregate payments would increase by 3.1
percent; assuming hospices do not change their billing practices. As
illustrated in Table 9, 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 2022 as seen on Medicare
hospice claims (accessed from the CCW on May 11, 2023) 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 9, the combined effects of all the
proposals vary by specific types of providers and by location.

[[Page 51194]]

[GRAPHIC] [TIFF OMITTED] TR02AU23.086

[[Page 51195]]

[GRAPHIC] [TIFF OMITTED] TR02AU23.087

[[Page 51196]]

[GRAPHIC] [TIFF OMITTED] TR02AU23.088

2. Regulatory Review Cost Estimation
If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this 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 rule, we assume that the total number of unique
commenters on this year's proposed rule will be the number of reviewers
of this final rule. We acknowledge that this assumption may understate
or overstate the costs of reviewing this rule. It is possible that not
all commenters reviewed this year's rule in detail, and it is also
possible that some reviewers chose not to comment on the proposed rule.
For these reasons we believe that the number of past commenters would
be a fair estimate of the number of reviewers of this final rule. We
welcomed public comments on the approach in estimating the number of
entities that would review the proposed rule. We did not receive any
public comments specific to our solicitation.
We also recognize that different types of entities are in many
cases affected by mutually exclusive sections of this rule, and
therefore for the purposes of our estimate we assume that each reviewer
reads approximately 50 percent of the rule. We sought public comments
on this assumption, and we did not receive any public comments.
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 rule is $115.22 per hour, including
overhead and fringe benefits (<a href="https://www.bls.gov/oes/current/oes119111.htm">https://www.bls.gov/oes/current/oes119111.htm</a>). This final rule consists of approximately 32,000 words.
Assuming an average reading speed of 250 words per minute, it would
take approximately 2 hours for staff to review half of it. For each
hospice that reviews the rule, the estimated cost is $230.44 (2 hours x
$115.22). Therefore, we estimate that the total cost of reviewing this
regulation is $8,756.72 ($115.22 x 76 reviewers).
3. Impacts for the Hospice Quality Reporting Program for FY 2024
The HQRP requires the active collection under OMB control number
#0938-1153 (CMS 10390; expiration 02/29/2024) of the Hospice Items Set
(HIS) and CAHPS[supreg] Hospice Survey (OMB control number 0938-1257

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