[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Proposed Rules]
[Pages 19700-19774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07344]



[[Page 19699]]

Vol. 86

Wednesday,

No. 70

April 14, 2021

Part II





 Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 418 and 484





Medicare Program; FY 2022 Hospice Wage Index and Payment Rate Update, 
Hospice Conditions of Participation Updates, Hospice and Home Health 
Quality Reporting Program Requirements; Proposed Rule

  Federal Register / Vol. 86 , No. 70 / Wednesday, April 14, 2021 / 
Proposed Rules  

[[Page 19700]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 418 and 484

[CMS-1754-P]
RIN 0938-AU41


Medicare Program; FY 2022 Hospice Wage Index and Payment Rate 
Update, Hospice Conditions of Participation Updates, Hospice and Home 
Health Quality Reporting Program Requirements

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This rule proposes updates to the hospice wage index, payment 
rates, and aggregate cap amount for Fiscal Year 2022. This rule 
proposes changes to the labor shares of the hospice payment rates, 
proposes clarifying regulations text changes to the election statement 
addendum that was implemented on October 1, 2020, includes information 
on hospice utilization trends and solicits comments regarding hospice 
utilization and spending patterns. In addition, this rule proposes to 
make permanent selected regulatory blanket waivers that were issued to 
Medicare-participating hospice agencies during the COVID-19 public 
health emergency and updates the hospice conditions of participation. 
The proposed rule would update the Hospice Quality Reporting Program. 
The proposed rule requests information on advancing to digital quality 
measurement, the use of Fast Healthcare Interoperability Resources, 
addresses the White House Executive Order related to health equity in 
the Hospice Quality Reporting Program and provides updates to advancing 
Health Information Exchange. Finally, this rule proposes changes 
beginning with the January 2022 public reporting for the Home Health 
Quality Reporting Program to address exceptions related to the COVID-19 
public health emergency.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below by June 7, 2021.

ADDRESSES: In commenting, refer to file code CMS-1754-P.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (choose only one of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1754-P, P.O. Box 8010, 
Baltimore, MD 21244-1850.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1754-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    For general questions about hospice payment policy, send your 
inquiry via email to: [email protected].
    For questions regarding the CAHPS[supreg] Hospice Survey, contact 
Debra Dean-Whittaker at (410) 786-0848.
    For questions regarding the hospice conditions of participation 
(CoPs), contact Mary Rossi-Coajou at (410)786-6051.
    For questions regarding the home health public reporting, contact 
Charles Padgett (410) 786-2811.
    For questions regarding the hospice quality reporting program, 
contact Cindy Massuda at (410) 786-0652.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments.
    Wage index addenda will be available only through the internet on 
our website at: (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index.html.)

I. Executive Summary

A. Purpose

    This rule proposes updates to the hospice wage index, payment 
rates, and cap amount for Fiscal Year (FY) 2022 as required under 
section 1814(i) of the Social Security Act (the Act). In addition, this 
rule proposes to rebase the labor shares of the hospice payment rates 
and proposes clarifying regulations text changes to the election 
statement addendum requirements finalized in the FY 2020 Hospice Wage 
Index and Payment Rate Update final rule (84 FR 38484). This rule also 
includes information on hospice utilization trends and solicits 
comments regarding hospice utilization and spending patterns. In 
addition, this rule proposes to make permanent selected regulatory 
blanket waivers for hospice agencies during the COVID-19 Public Health 
Emergency (PHE) and proposes revisions to the hospice conditions of 
participation (CoPs). This rule proposes changes to the Hospice Quality 
Reporting Program (HQRP), requests information on advancing to digital 
quality measurement and the use of Fast Healthcare Interoperability 
Resources (FHIR), addresses the White House Executive Order related to 
health equity in the HQRP and provides updates on advancing the Health 
Information Exchange. Finally, this rule proposes changes to the Home 
Health Quality Reporting Program (HH QRP) to address the January 2022 
refresh in accordance with sections 1895(b)(3)(B)(v)(III) and 
1899(B)(f) of the Act.

B. Summary of the Major Provisions

    Section III.A of this proposed rule includes data analysis on 
historical hospice utilization trends. The analysis includes data on 
the number of beneficiaries using the hospice benefit, live discharges, 
reported diagnoses on hospice claims, Medicare hospice spending, and 
Parts A, B and D non-hospice spending during a hospice election. In 
this section, we also solicit comments from the public, including 
hospice providers as well as patients and advocates, regarding the 
presented analysis on hospice utilization and spending patterns. We 
also include questions related to non-hospice spending during a hospice 
election.
    Section III.B of this proposed rule proposes to rebase and revise 
the labor shares for continuous home care (CHC), routine home care 
(RHC), inpatient respite care (IRC), and general inpatient care (GIP) 
using 2018 Medicare cost report (MCR) data for freestanding hospice 
facilities.
    Section III.C proposes updates to the hospice wage index and makes 
the application of the updated wage data budget neutral for all four 
levels of hospice care. In section III.C of this rule, we also discuss 
the proposed FY 2022 hospice payment update percentage of 2.3 percent, 
updates to the hospice payment rates, as well as the updates to

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the hospice cap amount for FY 2022 by the hospice payment update 
percentage of 2.3 percent.
    Section III.D proposes clarifying regulations text changes 
regarding the election statement addendum requirements that were 
finalized in the FY 2020 Hospice Wage Index and Rate Update final rule 
(84 FR 38484).
    Section III.E proposes to make permanent selected regulatory 
blanket waivers that were issued to Medicare-participating hospice 
agencies during the COVID-19 PHE. We are proposing to revise hospice 
aide requirements to allow the use of the pseudo-patient for conducting 
hospice aide competency evaluations. We are also proposing to revise 
the provisions at Sec.  418.76(h)(1)(iii) to state that if a hospice 
verifies during an on-site visit the finding of a supervising nurse 
regarding an area of concern in the performance of a hospice aide, the 
hospice must conduct and the hospice aide must complete a competency 
evaluation related to the deficient and related skill(s), in accordance 
with Sec.  418.76(c).
    In section III.F of this rule, we discuss proposals to the HQRP 
including the addition of claims-based Hospice Care Index (HCI) 
measure, and Hospice Visits in the Last Days of Life (HVLDL) measure 
for public reporting; removal of the seven Hospice Item Set (HIS) 
measures because a more broadly applicable measure, the NQF 3235 HIS 
Comprehensive Assessment Measure for the particular topic is available 
and already publicly reported; and further development of, Hospice 
Outcome and Patient Evaluation (HOPE) assessment instrument. We also 
provide updates on the public reporting change for one refresh cycle to 
report less than the standard quarters of data due to the COVID-19 PHE 
exemptions and adding the Consumer Assessment of Healthcare Providers 
and Systems (CAHPS[supreg]) Hospice Survey Star ratings. Additionally, 
there are requests for information (RFI) on advancing to digital 
quality measurement and the use of Fast Healthcare Interoperability 
Resources (FHIR) and on addressing the White House Executive Order 
related to health equity in the HQRP. In addition, this rule provides 
updates to advancing Health Information Exchange (HIE). The Department 
of Health and Human Services (HHS) has a number of initiatives designed 
to encourage and support the adoption of interoperable health 
information technology and to promote nationwide health information 
exchange to improve health care and patient access to their health 
information.
    Finally, in section III.G of this rule, we are proposing changes to 
the HH QRP to establish that, beginning with the January 2022 through 
the July 2024 public reporting refresh cycle, we will report fewer 
quarters of data due to COVID-19 PHE exceptions granted on March 27, 
2020. We include this Home Health proposal in this rule because we plan 
to resume public reporting for the HH QRP with the January 2022 refresh 
of Care Compare. In order to accommodate the exception of 2020 Q1 and 
Q2 data, we are proposing to resume public reporting using 3 out of 4 
quarters of data for the January 2022 refresh. In order to finalize 
this proposal in time to release the required preview report related to 
the refresh, which we release 3 months prior to any given refresh 
(October 2021), we need the rule containing this proposal to finalize 
by October 2021.

C. Summary of Impacts

    The overall economic impact of this proposed rule is estimated to 
be $530 million in increased payments to hospices for FY 2022.

II. Background

A. Hospice Care

    Hospice care is a comprehensive, holistic approach to treatment 
that recognizes the impending death of a terminally ill individual and 
warrants a change in the focus from curative care to palliative care 
for relief of pain and for symptom management. Medicare regulations 
define ``palliative care'' as patient and family-centered care that 
optimizes quality of life by anticipating, preventing, and treating 
suffering. Palliative care throughout the continuum of illness involves 
addressing physical, intellectual, emotional, social, and spiritual 
needs and to facilitate patient autonomy, access to information, and 
choice (42 CFR 418.3). Palliative care is at the core of hospice 
philosophy and care practices, and is a critical component of the 
Medicare hospice benefit.
    The goal of hospice care is to help terminally ill individuals 
continue life with minimal disruption to normal activities while 
remaining primarily in the home environment. A hospice uses an 
interdisciplinary approach to deliver medical, nursing, social, 
psychological, emotional, and spiritual services through a 
collaboration of professionals and other caregivers, with the goal of 
making the beneficiary as physically and emotionally comfortable as 
possible. Hospice is compassionate beneficiary and family/caregiver-
centered care for those who are terminally ill.
    As referenced in our regulations at Sec.  418.22(b)(1), to be 
eligible for Medicare hospice services, the patient's attending 
physician (if any) and the hospice medical director must certify that 
the individual is ``terminally ill,'' as defined in section 
1861(dd)(3)(A) of the Act and our regulations at Sec.  418.3; that is, 
the individual has a medical prognosis that his or her life expectancy 
is 6 months or less if the illness runs its normal course. The 
regulations at Sec.  418.22(b)(2) require that clinical information and 
other documentation that support the medical prognosis accompany the 
certification and be filed in the medical record with it and those 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 team, 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 his or her 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

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individual can remain at home. Continuous home care 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 continuous home care 
rate (Sec.  418.302(e)(4)).
    Hospices must comply with applicable civil rights laws,\1\ 
including section 504 of the Rehabilitation Act of 1973 and the 
Americans with Disabilities Act, under which covered entities must take 
appropriate steps to ensure effective communication with patients and 
patient care representatives with disabilities, including the 
provisions of auxiliary aids and services. Additionally, they must take 
reasonable steps to ensure meaningful access for individuals with 
limited English proficiency, consistent with Title VI of the Civil 
Rights Act of 1964. Further information about these requirements may be 
found at: http://www.hhs.gov/ocr/civilrights.
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    \1\ Hospices are also subject to additional Federal civil rights 
laws, including the Age Discrimination Act, Section 1557 of the 
Affordable Care Act, and conscience and religious freedom laws.
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B. Services Covered by the Medicare Hospice Benefit

    Coverage under the Medicare hospice benefit requires that hospice 
services must be reasonable and necessary for the palliation and 
management of the terminal illness and related conditions. Section 
1861(dd)(1) of the Act establishes the services that are to be rendered 
by a Medicare-certified hospice program. These covered services 
include: Nursing care; physical therapy; occupational therapy; speech-
language pathology therapy; medical social services; home health aide 
services (called hospice aide services); physician services; homemaker 
services; medical supplies (including drugs and 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, though 
Medicare does not pay for these volunteer services (section 
1861(dd)(2)(E) of the Act). As stated in the FY 1983 Hospice Wage Index 
and Rate Update proposed rule (48 FR 38149), the hospice must have an 
interdisciplinary group composed of paid hospice employees as well as 
hospice volunteers, and that ``the hospice benefit and the resulting 
Medicare reimbursement is not intended to diminish the voluntary spirit 
of hospices.'' This expectation supports the hospice philosophy of 
community based, holistic, comprehensive, and compassionate end of life 
care.

C. Medicare Payment for Hospice Care

    Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of 
the Act, and the regulations in 42 CFR part 418, establish eligibility 
requirements, payment standards and procedures; define covered 
services; and delineate the conditions a hospice must meet to be 
approved for participation in the Medicare program. Part 418, subpart 
G, provides for a per diem payment based on one of four prospectively-
determined rate categories of hospice care (RHC, CHC, IRC, and GIP), 
based on each day a qualified Medicare beneficiary is under hospice 
care (once the individual has elected). This per diem payment is meant 
to cover all of the hospice services and items needed to manage the 
beneficiary's care, as required by section 1861(dd)(1) of the Act.
    While payments 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 the prohibited 
activities, even in the context of a per diem payment. While recent 
news reports \2\ have brought to light the potential role hospices 
could play in medical aid in dying (MAID) where such practices have 
been legalized in certain states, we wish to remind hospices that The 
Assisted Suicide Funding Restriction Act of 1997 (Pub. L. 105-12) 
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. https://www.medscape.com/viewarticle/925769#vp_1.
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1. Omnibus Budget Reconciliation Act of 1989
    Section 6005(a) of the Omnibus Budget Reconciliation Act of 1989 
(Pub. L. 101-239) amended section 1814(i)(1)(C) of the Act and provided 
changes in the methodology concerning updating the daily payment rates 
based on the hospital market basket percentage increase applied to the 
payment rates in effect during the previous Federal fiscal year.
2. Balanced Budget Act of 1997
    Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 
105-33) established that updates to the hospice payment rates beginning 
FY 2002 and subsequent FYs be the hospital market basket percentage 
increase for the FY. Section 4442 of the BBA amended section 1814(i)(2) 
of the Act, effective for services furnished on or after October 1, 
1997, to require that hospices submit claims for payment for hospice 
care furnished in an individual's home only on the basis of the 
geographic location at which the service is furnished. Previously, 
local wage index values were applied based on the geographic location 
of the hospice provider, regardless of where the hospice care was 
furnished. Section 4443 of the BBA amended sections 1812(a)(4) and 
1812(d)(1) of the Act to provide for hospice benefit periods of two 90-
day periods, followed by an unlimited number of 60-day periods.
3. FY 1998 Hospice Wage Index Final Rule
    The FY 1998 Hospice Wage Index final rule (62 FR 42860), 
implemented a new methodology for calculating the

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hospice wage index and instituted an annual Budget Neutrality 
Adjustment Factor (BNAF) so aggregate Medicare payments to hospices 
would remain budget neutral to payments calculated using the 1983 wage 
index.
4. FY 2010 Hospice Wage Index Final Rule
    The FY 2010 Hospice Wage Index and Rate Update final rule (74 FR 
39384) instituted an incremental 7-year phase-out of the BNAF beginning 
in FY 2010 through FY 2016. The BNAF phase-out reduced the amount of 
the BNAF increase applied to the hospice wage index value, but was not 
a reduction in the hospice wage index value itself or in the hospice 
payment rates.
5. The Affordable Care Act
    Starting with FY 2013 (and in subsequent FYs), the market basket 
percentage update under the hospice payment system referenced in 
sections 1814(i)(1)(C)(ii)(VII) and 1814(i)(1)(C)(iii) of the Act are 
subject to annual reductions related to changes in economy-wide 
productivity, as specified in section 1814(i)(1)(C)(iv) of the Act.
    In addition, sections 1814(i)(5)(A) through (C) of the Act, as 
added by section 3132(a) of the Patient Protection and Affordable Care 
Act (PPACA) (Pub. L. 111-148), required hospices to begin submitting 
quality data, based on measures specified by the Secretary of the 
Department of Health and Human Services (the Secretary), for FY 2014 
and subsequent FYs. Since FY 2014, hospices that fail to report quality 
data have their market basket percentage increase reduced by 2 
percentage points. Note that with the passage of the Consolidated 
Appropriations Act, 2021 (hereafter referred to as CAA 2021) (Pub. L. 
116-260), the reduction changes to 4 percentage points beginning in FY 
2024.
    Section 1814(a)(7)(D)(i) of the Act, as added by section 3132(b)(2) 
of the PPACA, required, effective January 1, 2011, that a hospice 
physician or nurse practitioner have a face-to-face encounter with the 
beneficiary to determine continued eligibility of the beneficiary's 
hospice care prior to the 180th day recertification and each subsequent 
recertification, and to attest that such visit took place. When 
implementing this provision, the Centers for Medicare & Medicaid 
Services (CMS) finalized in the FY 2011 Hospice Wage Index final rule 
(75 FR 70435) that the 180th day recertification and subsequent 
recertifications would correspond to the beneficiary's third or 
subsequent benefit periods. Further, section 1814(i)(6) of the Act, as 
added by section 3132(a)(1)(B) of the PPACA, authorized the Secretary 
to collect additional data and information determined appropriate to 
revise payments for hospice care and other purposes. The types of data 
and information suggested in the PPACA could capture accurate resource 
utilization, which could be collected on claims, cost reports, and 
possibly other mechanisms, as the Secretary determined to be 
appropriate. The data collected could be used to revise the methodology 
for determining the payment rates for RHC and other services included 
in hospice care, no earlier than October 1, 2013, as described in 
section 1814(i)(6)(D) of the Act. In addition, CMS was required to 
consult with hospice programs and the Medicare Payment Advisory 
Commission (MedPAC) regarding additional data collection and payment 
revision options.
6. FY 2012 Hospice Wage Index Final Rule
    In the FY 2012 Hospice Wage Index final rule (76 FR 47308 through 
47314) it was announced that beginning in 2012, the hospice aggregate 
cap would be calculated using the patient-by-patient proportional 
methodology, within certain limits. Existing hospices had the option of 
having their cap calculated through the original streamlined 
methodology, also within certain limits. As of FY 2012, new hospices 
have their cap determinations calculated using the patient-by-patient 
proportional methodology. If a hospice's total Medicare payments for 
the cap year exceed the hospice aggregate cap, then the hospice must 
repay the excess back to Medicare.
7. IMPACT Act of 2014
    The Improving Medicare Post-Acute Care Transformation Act of 2014 
(IMPACT Act) (Pub. L. 113-185) became law on October 6, 2014. Section 
3(a) of the IMPACT Act mandated that all Medicare certified hospices be 
surveyed every 3 years beginning April 6, 2015 and ending September 30, 
2025. In addition, section 3(c) of the IMPACT Act requires medical 
review of hospice cases involving beneficiaries receiving more than 180 
days of care in select hospices that show a preponderance of such 
patients; section 3(d) of the IMPACT Act contains a new provision 
mandating that the cap amount for accounting years that end after 
September 30, 2016, and before October 1, 2025 be updated by the 
hospice payment percentage update rather than using the consumer price 
index for urban consumers (CPI-U) for medical care expenditures.
8. FY 2015 Hospice Wage Index and Payment Rate Update Final Rule
    The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 
50452) finalized a requirement that the Notice of Election (NOE) be 
filed within 5 calendar days after the effective date of hospice 
election. If the NOE is filed beyond this 5-day period, hospice 
providers are liable for the services furnished during the days from 
the effective date of hospice election to the date of NOE filing (79 FR 
50474). As with the NOE, the claims processing system must be notified 
of a beneficiary's discharge from hospice or hospice benefit revocation 
within 5 calendar days after the effective date of the discharge/
revocation (unless the hospice has already filed a final claim) through 
the submission of a final claim or a Notice of Termination or 
Revocation (NOTR).
    The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 
50479) also finalized a requirement that the election form include the 
beneficiary's choice of attending physician and that the beneficiary 
provide the hospice with a signed document when he or she chooses to 
change attending physicians.
    In addition, the FY 2015 Hospice Wage Index and Rate Update final 
rule (79 FR 50496) provided background, described eligibility criteria, 
identified survey respondents, and otherwise implemented the Hospice 
Experience of Care Survey for informal caregivers. Hospice providers 
were required to begin using this survey for hospice patients as of 
2015.
    Finally, the FY 2015 Hospice Wage Index and Rate Update final rule 
required providers to complete their aggregate cap determination not 
sooner than 3 months after the end of the cap year, and not later than 
5 months after, and remit any overpayments. Those hospices that fail to 
submit their aggregate cap determinations on a timely basis will have 
their payments suspended until the determination is completed and 
received by the Medicare contractor (79 FR 50503).
9. FY 2016 Hospice Wage Index and Payment Rate Update Final Rule
    In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 
47142), CMS finalized two different payment rates for RHC: A higher per 
diem base payment rate for the first 60 days of hospice care and a 
reduced per diem base payment rate for subsequent days of hospice care. 
CMS also finalized a service intensity add-on (SIA)

[[Page 19704]]

payment payable for certain services during the last 7 days of the 
beneficiary's life. A service intensity add-on payment will be made for 
the social worker visits and nursing visits provided by a registered 
nurse (RN), when provided during routine home care in the last 7 days 
of life. The SIA payment is in addition to the routine home care rate. 
The SIA payment is provided for visits of a minimum of 15 minutes and a 
maximum of 4 hours per day (80 FR 47172).
    In addition to the hospice payment reform changes discussed, the FY 
2016 Hospice Wage Index and Rate Update final rule implemented changes 
mandated by the IMPACT Act, in which the cap amount for accounting 
years that end after September 30, 2016 and before October 1, 2025 
would be updated by the hospice payment update percentage rather than 
using the CPI-U (80 FR 47186). In addition, we finalized a provision to 
align the cap accounting year for both the inpatient cap and the 
hospice aggregate cap with the FY for FY 2017 and thereafter. Finally, 
the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47144) 
clarified that hospices would have to report all diagnoses on the 
hospice claim as a part of the ongoing data collection efforts for 
possible future hospice payment refinements.
10. FY 2017 Hospice Wage Index and Payment Rate Update Final Rule
    In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 
52160), CMS finalized several new policies and requirements related to 
the HQRP. First, CMS codified the policy that if the National Quality 
Forum (NQF) made non-substantive changes to specifications for HQRP 
measures as part of the NQF's re-endorsement process, CMS would 
continue to utilize the measure in its new endorsed status, without 
going through new notice-and-comment rulemaking. CMS would continue to 
use rulemaking to adopt substantive updates made by the NQF to the 
endorsed measures adopted for the HQRP; determinations about what 
constitutes a substantive versus non-substantive change would be made 
on a measure-by-measure basis. Second, we finalized two new quality 
measures for the HQRP for the FY 2019 payment determination and 
subsequent years: Hospice Visits when Death is Imminent Measure Pair 
and Hospice and Palliative Care Composite Process Measure-Comprehensive 
Assessment at Admission (81 FR 52173). The data collection mechanism 
for both of these measures is the Hospice Item Set (HIS), and the 
measures were effective April 1, 2017. Regarding the CAHPS[supreg] 
Hospice Survey, CMS finalized a policy that hospices that receive their 
CMS Certification Number (CCN) after January 1, 2017 for the FY 2019 
Annual Payment Update (APU) and January 1, 2018 for the FY 2020 APU 
will be exempted from the Hospice CAHPS[supreg] requirements due to 
newness (81 FR 52182). The exemption is determined by CMS and is for 1 
year only.
11. FY 2020 Hospice Wage Index and Payment Rate Update Final Rule
    In the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 
38484), we finalized rebased payment rates for CHC and GIP and set 
those rates equal to their average estimated FY 2019 costs per day. We 
also rebased IRC per diem rates equal to the estimated FY 2019 average 
costs per day, with a reduction of 5 percent to the FY 2019 average 
cost per day to account for coinsurance. We finalized the FY 2020 
proposal to reduce the RHC payment rates by 2.72 percent to offset the 
increases to CHC, IRC, and GIP payment rates to implement this policy 
in a budget-neutral manner in accordance with section 1814(i)(6) of the 
Act (84 FR 38496).
    In addition, we finalized a policy to use the current year's pre-
floor, pre-reclassified hospital inpatient wage index as the wage 
adjustment to the labor portion of the hospice rates. Finally, in the 
FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38505), we 
finalized modifications to the hospice election statement content 
requirements at Sec.  418.24(b) by requiring hospices, upon request, to 
furnish an election statement addendum effective beginning in FY 2021. 
The addendum must list those items, services, and drugs the hospice has 
determined to be unrelated to the terminal illness and related 
conditions, increasing coverage transparency for beneficiaries under a 
hospice election.
12. Consolidated Appropriations Act, 2021
    Division CC, section 404 of the CAA 2021 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 update reduced by the multifactor 
productivity adjustment) rather than the CPI-U for accounting years 
that end after September 30, 2016 and before October 1, 2030. Prior to 
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, 2025. Division CC, section 407 of CAA 
2021 revises section 1814(i)(5)(A)(i) to increase the payment reduction 
for hospices who fail to meet hospice quality measure reporting 
requirements from two percent to four percent beginning with FY 2024.

III. Provisions of the Proposed Rule

A. Hospice Utilization and Spending Patterns

    CMS provides analysis as it relates to hospice utilization such as 
Medicare spending, utilization by level of care, lengths of stay, live 
discharge rates, and skilled visits during the last days of life using 
the most recent, complete claims data. Stakeholders report that such 
data can be used to educate hospices on Medicare policies to help 
ensure compliance. Moreover, in response to the Office of Inspector 
General (OIG) reports highlighting vulnerabilities in the Medicare 
hospice benefit including hospices engaging in inappropriate billing, 
not providing needed services and crucial information to beneficiaries 
in order for them to make informed decisions about their care, \3\ we 
continue to monitor both hospice and non-hospice spending during a 
hospice election. We are still analyzing the effects of the COVID-19 
PHE as it relates to the following routine monitoring analysis and 
whether those effects are likely to be temporary or permanent and if 
such effects vary significantly across hospice providers. Therefore, 
for the purposes of providing routine analysis on utilization and 
spending, in this proposed rule, we used the most complete data we have 
from FY 2019.
---------------------------------------------------------------------------

    \3\ ``Hospice Inappropriately Billed Medicare Over $250 Million 
for General Inpatient Care'', OEI-02-10-00491, March, 2016. 
``Vulnerabilities in the Medicare Hospice Program Affect Quality 
Care and Program Integrity: An OIG Portfolio'', OEI-02-16-00570, 
July, 2018.
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1. General Hospice Utilization Trends
    Since the implementation of the hospice benefit in 1983, there has 
been substantial growth in hospice utilization. The number of Medicare 
beneficiaries receiving hospice services has grown from 584,438 in FY 
2001 to over 1.6 million in FY 2019. Medicare hospice expenditures have 
risen from $3.5 billion in FY 2001 to approximately $20 billion in FY 
2019.\4\ CMS' Office of the Actuary (OACT) projects that aggregate 
hospice expenditures are expected to continue to increase, by 
approximately 7.6 percent annually. We note that the

[[Page 19705]]

average spending per beneficiary has also increased between FY 2010 and 
FY 2019 from approximately $11,158 in FY 2010 to $12,687 in FY 2019.\5\
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    \4\ Source: Analysis of data for FY 2001 through FY 2019 
accessed from the Chronic Conditions Data Warehouse (CCW) on January 
15, 2021.
    \5\ Source: Analysis of data for FY 2010 through FY 2019 
accessed from the CCW on Jan 15, 2021.
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    The percentage of Medicare decedents who died while receiving 
services under the Medicare hospice benefit has increased as shown in 
Table 1.
[GRAPHIC] [TIFF OMITTED] TP14AP21.000

    Similar to the increase in the number of beneficiaries using the 
benefit, the total number of organizations offering hospice services 
also continues to grow, with for-profit providers entering the market 
at higher rates than not-for-profit providers. In its March 2020 Report 
to the Congress, MedPAC stated that for more than a decade, the 
increasing number of hospice providers is due almost entirely to the 
entry of for-profit providers. MedPAC also stated that long stays in 
hospice have been very profitable and this has attracted new provider 
entrants with revenue-generating strategies specifically targeting 
those patients expected to have longer lengths of stay.\6\ Freestanding 
hospices continue to dominate the market as a whole. In FY 2019, 68 
percent (3,254 out of 4,811) of hospices were for-profit and 21 percent 
(987 out of 4,811) were non-profit, whereas in FY 2014, 61 percent 
(2,513 out of 4,108) were for-profit and 25 percent (1,029 out of 
4,108) of hospices were non-profit. In FY 2019, for-profit hospices 
provided approximately 58 percent of all hospice days while non-profit 
hospices provided 31 percent of all hospice days.\7\ Hospices that 
listed their ownership status as ``Other'', ``Government'' or had an 
unknown ownership status accounted for the remaining percentage of 
hospice days.
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    \6\ Report to Congress, Medicare Payment Policy. Hospice 
Services, Chapter 12. MedPAC. March 2020. http://www.medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
    \7\ Source: FY 2014-FY 2019 hospice claims data from CCW on 
January 15, 2021. December 2020 Provider of Service (POS) File 
(https://www.cms.gov/files/zip/posothercsvdec19.zip).
    Notes: Using the Analytic file, we found there were 4,971 
hospices that submitted at least one claim in FY 2019. Of those, we 
show the frequency of their ownership type as shown in the POS file. 
For-profit hospices include the ``proprietary'' categories. Non-
profit includes the ``voluntary non-profit'' categories. Government 
includes the ``Government'' categories and the ``Combination 
Government & Nonprofit'' option. Other represents the ``other'' 
category. One hospice could not be linked to the POS file and is 
listed as unknown.
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    There have been notable changes in the pattern of diagnoses among 
Medicare hospice enrollees since the implementation of the Medicare 
hospice benefit from primarily cancer diagnoses to neurological 
diagnoses, including Alzheimer's disease and other related dementias 
(80 FR 25839). Our ongoing analysis of diagnosis reporting finds that 
neurological and organ-based failure conditions remain the top-reported 
principal diagnoses. Beneficiaries with these terminal conditions tend 
to have longer hospice stays, which have historically been more 
profitable than shorter stays.\8\ Table 2 shows the top 20 most 
frequently reported principal diagnoses on FY 2019 hospice claims.
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    \8\ Report to Congress, Medicare Payment Policy. Hospice 
Services, Chapter 12. MedPAC. March 2020. http://www.medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
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Hospice Utilization by Level of Care
    Our analysis shows that there have only been slight changes over 
time in how hospices have been utilizing the different levels of care. 
RHC consistently represents the highest percentage of total hospice 
days as well as the highest percentage of total hospice payments as 
shown in Tables 3 and 4).

[[Page 19707]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.003

[GRAPHIC] [TIFF OMITTED] TP14AP21.004

    In the FY 2020 Hospice Wage Index and Payment Rate Update final 
rule (84 FR 38496), we rebased the payment rates for the CHC, IRC, and 
GIP levels of care to better align hospice payment with the costs of 
providing care. We will continue to monitor the effects of these 
rebased rates to determine if there are any notable shifts in the 
provision of care or any other perverse utilization patterns that would 
warrant any program integrity or survey actions.
2. Trends in Hospice Length of Stay, Live Discharges and Skilled Visits 
in the Last Days of Life Analysis
    Eligibility under the Medicare hospice benefit is predicated on the 
individual being certified as terminally ill. Medicare regulations at 
Sec.  418.3 define ``terminally ill'' to mean that the individual has a 
medical prognosis that his or her life expectancy is 6 months or less 
if the illness runs its normal course. However, we recognize that a 
beneficiary may be under a hospice election longer than 6 months, as 
long as there remains a reasonable expectation that the individuals 
have a life expectancy of 6 months or less. It has always been our 
expectation that the certifying physicians will use their best clinical 
judgment, in accordance with the regulations at Sec. Sec.  418.22 and 
418.25, to determine if the individual has a life expectancy of 6 
months or less with each certification and recertification.
Hospice Length of Stay
    We examined hospice length of stay in three ways: (1) Average 
length of election, meaning the number of hospice days during a single 
hospice election at the time of live discharge or death; (2) the median 
lifetime length of stay, which represents the 50th percentile, and; (3) 
average lifetime length of stay, which includes the sum of all days of 
hospice care across all hospice elections. Extremely long lengths of 
stay influence both the average length of election and average lifetime 
length of stay. Table 5 shows the average length of election, the 
median and average lifetime lengths of stay from FYs 2016 through 2019.
[GRAPHIC] [TIFF OMITTED] TP14AP21.005

    Length of stay estimates vary based on the reported principal 
diagnosis Table 6 lists the top six clinical categories of principal 
diagnoses reported on hospice claims in FY 2019 along with the 
corresponding number of hospice discharges. Patients with neurological 
and organ-based failure conditions (with the exception of kidney 
disease/kidney failure) tend to have much longer lengths of stay 
compared to patients with cancer diagnoses.

[[Page 19708]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.006

Hospice Live Discharges
    Federal regulations limit the circumstances in which a Medicare 
hospice provider may discharge a patient from its care. In accordance 
with Sec.  418.26, discharge from hospice care is permissible when the 
patient moves out of the provider's service area, is determined to be 
no longer terminally ill, or for cause. Hospices may not discharge the 
patient at their discretion, even if the care may be costly or 
inconvenient for the hospice. Additionally, an individual or 
representative may revoke the individual's election of hospice care at 
any time during an election period in accordance with the regulations 
at Sec.  418.28. However, at any time thereafter, the beneficiary may 
re-elect hospice coverage at any other hospice election period that 
they are eligible to receive. Immediately upon hospice revocation, 
Medicare coverage resumes for those Medicare benefits previously waived 
with the hospice election. Only the beneficiary (or representative) can 
revoke the hospice election. A revocation must be in writing and must 
specify the effective date of the revocation. A hospice cannot revoke a 
beneficiary's hospice election, nor is it appropriate for hospices to 
encourage, request, or demand that the beneficiary or his or her 
representative revoke his or her hospice election.
    From FY 2014 through FY 2019, the average live discharge rate has 
been approximately 17 percent per year. Of the live discharges in FY 
2019, 37.5 percent were because of revocations, 37.2 percent were 
because the beneficiary was determined to no longer be terminally ill, 
10.7 percent were because beneficiaries moved out of the service area 
without transferring hospices, and 12.9 percent were because 
beneficiaries transferred to another hospice (see Figure 1). The 
remaining 1.6 percent were discharged for cause.\9\ Figure 1 shows the 
average annual rates of live discharge rates from FYs 2010 through 
2019.
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    \9\ For cause is defined in Chapter 9, Section 20.2.3 of the 
Hospice Benefit Policy Manual. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c09.pdf.

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[[Page 19709]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.007

    Finally, we looked at the distribution of live discharges by length 
of stay intervals. Figure 2 shows the live discharge rates by length of 
stay intervals from FY 2016 through FY 2019. We found that the majority 
of live discharges occur in the first 30 days of hospice care and after 
180 days of hospice care. The proportion of live discharges occurring 
between the lengths of stay intervals was relatively constant from FY 
2016 to FY 2019 where approximately 25 percent of live discharges 
occurred within 30 days of the start of hospice care, and approximately 
32 percent occurred after a length of stay over 180 days of hospice 
care.

[[Page 19710]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.008

Service Intensity Add-On (SIA) Payment
    A hospice's costs typically follow a U-shaped curve, with higher 
costs at the beginning and end of a stay, and lower costs in the middle 
of the stay. This cost curve reflects hospices' higher service 
intensity at the time of the patient's admission and the time 
surrounding the patient's death.\10\ In the period immediately 
preceding death, patient needs typically surge and more intensive 
services are typically warranted, and where the provision of care would 
proportionately escalate to meet the increased clinical, emotional, and 
other needs of the hospice beneficiary and his or her family and 
caregiver(s).
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    \10\ Reforming Medicare's Hospice Benefit. MedPAC. March 2009. 
http://www.medpac.gov/docs/default-source/reports/Mar09_Ch06.pdf?sfvrsn=0.
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    In the FY 2016 Hospice Rate Update final rule (80 FR 47142), we 
established two different payment rates for RHC to reflect the cost of 
providing hospice care throughout the course of a hospice election. We 
finalized a higher base payment rate for the first 60 days of hospice 
care and a reduced base payment rate for days 61 and later. (80 FR 
47172). To reflect higher costs associated with the last 7 days of 
life, in FY 2016, we implemented the service intensity add-on payment 
(SIA) for RHC when direct patient care is provided by a RN or social 
worker during the last 7 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 on the day of service (up to 4 hours), if certain 
criteria are met (80 FR 47177). This effort represented meaningful 
advances in encouraging visits to hospice beneficiaries during the time 
preceding death and where patient and family needs typically intensify.
    To examine the effects of the SIA payment, we analyzed claims since 
the implementation of the SIA payment to determine if there was an 
increase in RN and social worker visits in the last seven days of life. 
In CY 2015 (the year preceding the SIA payment), the percentage of 
beneficiaries who did not receive a skilled nursing or social worker 
visit on the last day of life (when the last day of life was RHC) was 
nearly 23 percent. Our analysis shows a slight decline in the number of 
beneficiaries who did not receive an RN or social worker visit on the 
last day of life (when the last day of life was RHC) where the 
percentage trended downward to just over 19 percent in CYs 2017 to 
2019. This trend is similar for the 4 days leading up to the end of 
life (when the last 4 days of life were RHC), meaning beneficiaries are 
receiving more skilled nursing and social worker visits during the last 
days of life since implementation of the SIA payment. Table 7 shows the 
percentage of decedents not receiving skilled visits at the end of life 
for CY 2015 through CY 2019.
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[[Page 19711]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.009

    SIA payments have increased from FY 2016 through FY 2019 from $88 
million to $150 million respectively as shown in Figure 3.

[[Page 19712]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.010

BILLING CODE 4120-01-C
    To further evaluate the impact of the SIA, we examined the total 
amount of minutes provided by skilled nurses and social workers in the 
last 7 days of life and overall there were only modest changes from CY 
2015 to CY 2019, as shown in Table 8.\11\ MedPAC had examined skilled 
nurse and social worker minutes in the last 7 days of life from CY 2015 
through 2018 in their March 2020 Report to Congress and similarly found 
little change overall.\12\
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    \11\ Note: The SIA technically only applies to registered nurses 
and non-telephonic social worker visits. The distinction was not 
widely possible in the claims data prior to the SIA's 
implementation. For the analyses in this section we examine all 
skilled nurse and social worker visits, broadly.
    \12\ Report to Congress, Medicare Payment Policy. Hospice 
Services, Chapter 12. MedPAC. March 2020. http://www.medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.

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[[Page 19713]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.011

3. Non-Hospice Spending During a Hospice Election
    The Medicare hospice per diem payment amounts were developed to 
cover all services needed for the palliation and management of the 
terminal illness and related conditions, as described in section 
1861(dd)(1) of the Act. Hospice services provided under a written plan 
of care (POC) should reflect patient and family goals and interventions 
based on the problems identified in the initial, comprehensive, and 
updated comprehensive assessments. As referenced in our regulations at 
Sec.  418.64 and section II.B of this rule, a hospice must routinely 
provide all core services directly by hospice employees and they must 
be provided in a manner consistent with acceptable standards of 
practice. Under the current payment system, hospices are paid for each 
day that a beneficiary is enrolled in hospice care, regardless of 
whether services are rendered on any given day.
    Additionally, when a beneficiary elects the Medicare hospice 
benefit, he or she waives the right to Medicare payment for services 
related to the treatment of the terminal illness and related 
conditions, except for services provided by the designated hospice and 
the attending physician. The comprehensive nature of the services 
covered under the Medicare hospice benefit is structured such that 
hospice beneficiaries should not have to routinely seek items, 
services, and/or medications beyond those provided by hospice. We 
believe that it would be unusual and exceptional to see services 
provided outside of hospice for those individuals who are approaching 
the end of life and we have reiterated since 1983 that ``virtually 
all'' care needed by the terminally ill individual would be provided by 
the hospice.
    In examining overall non-hospice spending during a hospice 
election, Medicare paid over $1 billion in non-hospice spending during 
a hospice election in FY 2019 for items and services under Parts A, B, 
and D. Medicare payments for non-hospice Part A and Part B items and 
services received by hospice beneficiaries during a hospice election 
increased from $583 million in FY 2016 to $692 million in FY 2019 (see 
Figure 4). This represents an increase in non-hospice Medicare spending 
for Parts A and B of 18.7 percent. Whereas there is minimal beneficiary 
cost sharing under the Medicare hospice benefit,\13\ non-hospice 
services received outside of the Medicare hospice benefit are subject 
to beneficiary cost sharing. In FY 2019, the total beneficiary cost 
sharing amount was $170 million for Parts A and B.\14\
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    \13\ The amount of coinsurance for each prescription 
approximates 5 percent of the cost of the drug or biological to the 
hospice determined in accordance with the drug copayment schedule 
established by the hospice, except that the amount of coinsurance 
for each prescription may not exceed $5. The amount of coinsurance 
for each respite care day is equal to 5 percent of the payment made 
by CMS for a respite care.
    \14\ Part A and B cost sharing is calculated by summing together 
the deductible and coinsurance amounts for each claim.
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[[Page 19714]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.012

    We also examined non-hospice spending during a hospice election by 
claim type for Parts A and B, as shown in Table 9.

[[Page 19715]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.013

    Hospices are responsible for covering drugs and biologicals related 
to the palliation and management of the terminal illness and related 
conditions while the patient is under hospice care. For a prescription 
drug to be covered under Part D for an individual enrolled in hospice, 
the drug must be for treatment completely unrelated to the terminal 
illness or related conditions. After a hospice election, many 
maintenance drugs or drugs used to treat or cure a condition are 
typically discontinued as the focus of care shifts to palliation and 
comfort measures. However, those same drugs may be appropriate to 
continue as they may offer symptom relief for the palliation and 
management of the terminal prognosis.\15\ Similar to the increase in 
non-hospice spending during a hospice election for Medicare Parts A and 
B items and services, non-hospice spending for Part D drugs increased 
in from $353 million in FY 2016 to $499 million in FY 2019 (Figure 5).
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    \15\ Update on Part D Payment Responsibility for Drugs for 
Beneficiaries Enrolled in Medicare Hospice. November 2016. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/2016-11-15-Part-D-Hospice-Guidance.pdf.

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[[Page 19716]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.014

    Analysis of Part D prescription drug events (PDEs) data suggests 
that the current use of prior authorization (PA) by Part D sponsors has 
reduced Part D program payments for drugs in four targeted categories 
(analgesics, anti-nauseants, anti-anxiety, and laxatives), which are 
typically used to treat common symptoms experienced during the end of 
life. However, under Medicare Part D there has been an increase in 
hospice beneficiaries filling prescriptions for a separate category of 
drugs we refer to as maintenance drugs (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/2016-11-15-Part-D-Hospice-Guidance.pdf). Under CMS's current policy, Part D sponsors are 
not expected to place hospice PA requirements on categories of drugs 
(other than the four targeted categories listed above) or take special 
measures beyond their normal compliance and utilization review 
activities. Under this policy, sponsors are not expected to place PA 
requirements on maintenance drugs, for beneficiaries under a hospice 
election, though these drugs may still be subject to standard Part D 
formulary management practices. This policy was put in place in 
recognition of the operational challenges associated with requiring PA 
on all drugs for beneficiaries who have elected hospice and because of 
the potential barriers to access that could be created by requiring PA 
on all drugs.\16\ Examples of maintenance drugs are those used to treat 
high blood pressure, heart disease, asthma and diabetes. These 
categories include beta blockers, calcium channel blockers, 
corticosteroids, and insulin.
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    \16\ Part D Payment for Drugs for Beneficiaries Enrolled in 
Medicare Hospice. July 18, 2014. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/2014-PartD-Hospice-Guidance-Revised-Memo.pdf.
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    Table 10 details the various components of Part D spending for 
patients receiving hospice care for FY 2019. The portion of the FY 2019 
Part D spending that was paid by Medicare is the sum of the Low Income 
Cost-Sharing Subsidy and the Covered Drug Plan Paid Amount, 
approximately $499 million. The beneficiary cost sharing amount was 
approximately $59 million.\17\
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    \17\ Part D cost sharing is calculated by summing together the 
``the patient pay amount'' and the ``other true out of pocket'' 
amount that are recorded on the Part D PDE.

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[[Page 19717]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.015

Comment Solicitation on Analysis of Hospice Utilization and Spending 
Patterns
    We are soliciting comments on all aspects of the analysis presented 
in this proposed rule regarding hospice utilization and spending 
patterns. Our ongoing monitoring and analysis have shown that the 
hospice benefit has evolved; originally providing services primarily to 
patients with cancer, to now primarily patients with neurological 
conditions and organ-based failure. We are particularly interested in 
how this change in patient characteristics may have influenced any 
changes in the provision of hospice services. As mentioned in the above 
analysis, after the implementation of the SIA in FY 2016, the number of 
beneficiaries who did not receive an RN or social worker visit on the 
last day of has decreased. We are soliciting comments regarding skilled 
visits in the last week of life, particularly, what factors determine 
how and when visits are made as an individual approaches the end of 
life.
    Given the comprehensive and holistic nature of the services covered 
under the Medicare hospice benefit, we continue to expect that hospices 
are providing virtually all of the care needed by terminally ill 
individuals. However, the analysis of non-hospice spending during a 
hospice election indicates a continuing trend where there is a 
potential ``unbundling'' of items, services, and drugs from the 
Medicare hospice benefit. That is, there may be items, services, and 
drugs that should be covered under the Medicare hospice benefit but are 
being paid under other Medicare benefits. We are soliciting comments as 
to how hospices make determinations as to what items, services and 
drugs are related versus unrelated to the terminal illness and related 
conditions. That is, how do hospices define what is unrelated to the 
terminal illness and related conditions when establishing a hospice 
plan of care. Likewise, we are soliciting comments on what other 
factors may influence whether or how certain services are furnished to 
hospice beneficiaries. Finally, we are interested in stakeholder 
feedback as to whether the hospice election statement addendum has 
changed the way hospices make care decisions and how the addendum is 
used to prompt discussions with beneficiaries and non-hospice providers 
to ensure that the care needs of beneficiaries who have elected the 
hospice benefit are met.

B. FY 2022 Proposed Labor Shares

1. Background
    The labor share for CHC and RHC of 68.71 percent was established 
with the FY 1984 Hospice benefit implementation based on the wage/
nonwage proportions specified in Medicare's limit on home health agency 
costs (48 FR 38155 through 38156). The labor shares for IRC and GIP are 
currently 54.13 percent and 64.01 percent, respectively. These 
proportions were based on skilled nursing facility wage and nonwage 
cost limits and skilled nursing facility costs per day (48 FR 38155 
through 38156; 56 FR 26917).
    For the FY 2022 proposed rule, we are proposing to rebase and 
revise the labor shares for CHC, RHC, IRC and GIP using MCR data for 
freestanding hospices (CMS Form 1984-14, OMB NO. 0938-0758 \18\) for 
2018. We are proposing to continue to establish separate labor shares 
for CHC, RHC, IRC, and GIP and base them on the calculated compensation 
cost weights for each level of care from the 2018 MCR data. We describe 
our proposed methodology for deriving the compensation cost weights for 
each level of care using the MCR data below. We note that we did 
explore the possibility of using facility-based hospice MCR data to 
calculate the compensation cost weights; however, very few providers 
passed the Level I edits (as described in more detail below) and so 
these reports were not usable.
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    \18\ Hospice Facility Cost Report. https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-1984-14.
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1. Proposed Methodology for Calculating Compensation Costs
    We are proposing to derive a compensation cost weight for each 
level of care that consists of five major components: (1) Direct 
patient care salaries and contract labor costs, (2) direct patient care 
benefits costs, (3) other patient care salaries, (4) overhead salaries, 
and (5) overhead benefits costs. For each level of care, we are 
proposing to use the same methodology to derive the components; 
however, for the (1)

[[Page 19718]]

direct patient care salaries and (3) other patient care salaries, we 
are proposing to use the MCR worksheet that is specific to that level 
of care (that is, Worksheet A-1 for CHC, Worksheet A-2 for RHC, 
Worksheet A-3 for IRC, and Worksheet A-4 for GIP).
(1) Direct Patient Care Salaries and Contract Labor Costs
    Direct patient care salaries and contract labor costs are costs 
associated with medical services provided by medical personnel 
including but not limited to physician services, nurse practitioners, 
registered nurses, and hospice aides. We are proposing to define direct 
patient care salaries and contract labor costs to be equal to costs 
reported on Worksheet A-1 (for CHC) or Worksheet A-2 (for RHC) or 
Worksheet A-3 (for IRC) or Worksheet A-4 (for GIP), column 7, for lines 
26 through 37.
(2) Direct Patient Care Benefits Costs
    We are proposing that direct patient care benefits costs for CHC 
would be equal to Worksheet B, column 3, line 50, for RHC are equal to 
Worksheet B, column 3, line 51, for IRC are equal to Worksheet B, 
column 3, line 52, and for GIP are equal to Worksheet B, column 3, line 
53.
(3) Other Patient Care Salaries
    Other patient care salaries are those salaries attributable to 
patient services including but not limited to patient transportation, 
labs, and imaging services. These salaries, reflecting all levels of 
care, are reported on Worksheet A, column 1, lines 38 through 46 and 
then are further disaggregated for CHC, RHC, IRC, and GIP on Worksheets 
A-1, A-2, A-3, and A-4, respectively, on column 1 (salaries), lines 38 
through 46. Our analysis, however, found that many providers were not 
reporting salaries on the detailed level of care worksheets (A-1, A-2, 
A-3, A-4, column 1), but rather reporting total costs (reflecting 
salary and non-salary costs) for these services for each level of care 
on Worksheets A-1, A-2, A-3, A-4, column 7. Therefore, we are proposing 
to estimate other patient care salaries attributable to CHC, RHC, IRC, 
and GIP by first calculating the ratio of total facility (reflecting 
all levels of care) other patient care salaries (Worksheet A, column 1, 
lines 38 through 46) to total facility other patient care total costs 
(Worksheet A, column 7, lines 38 through 46). For CHC, we are proposing 
to then multiply this ratio by other patient care total costs for CHC 
(Worksheet A-1 column 7, lines 38 through 46). For RHC, we are 
proposing to multiply this ratio by total other patient care costs for 
RHC (Worksheet A-2, column 7, lines 38 through 46). For IRC, we are 
proposing to multiply this ratio by total other patient care costs for 
IRC (Worksheet A-3, column 7, lines 38 through 46). For GIP, we are 
proposing to multiply this ratio by total other patient care costs for 
GIP (Worksheet A-4, column 7, lines 38 through 46). This proposed 
methodology assumes that the proportion of salary costs to total costs 
for other patient care services is consistent for each of the four 
levels of care.
(4) Overhead Salaries
    The MCR captures total overhead costs (including but not limited to 
administrative and general, plant operations and maintenance, and 
housekeeping) attributable to each of the four levels of care. To 
estimate overhead salaries for each level of care, we first propose to 
calculate noncapital non-benefit overhead costs for each level of care 
to be equal to Worksheet B, column 18, less the sum of Worksheet B, 
columns 0 through 3, for line 50 (CHC), or line 51 (RHC) or line 52 
(IRC) or line 53 (GIP). We then are proposing to multiply these non-
capital non-benefit overhead costs for each level of care times the 
ratio of total facility overhead salaries (Worksheet A, column 1, lines 
4 through 16) to total facility non-capital non-benefit overhead costs 
(which is equal to Worksheet B, column 18 (total costs), line 101 less 
the sum of Worksheet B, columns 0 (direct patient care costs), column 1 
(fixed capital), column 2 (moveable capital) and column 3 (employee 
benefits), line 101).
(5) Overhead Benefits Costs
    To estimate overhead benefits costs for each level of care, we are 
proposing a similar methodology to overhead salaries. For each level of 
care, we are proposing to calculate noncapital overhead costs for each 
level of care to be equal to Worksheet B, column 18, less the sum of 
Worksheet B, columns 0 through 2, for line 50 (CHC), or line 51 (RHC) 
or line 52 (IRC) or line 53 (GIP). We then are proposing to multiply 
these non-capital overhead costs for each level of care times the ratio 
of total facility overhead benefits (Worksheet B, column 3, lines 4 
through 16) to total facility noncapital overhead costs (Worksheet B, 
column 18, line 101 less the sum of Worksheet B, columns 0 through 2, 
line 101). This proposed methodology assumes the ratio of total 
overhead benefit costs to total noncapital overhead costs is consistent 
among all four levels of care.
(6) Total Compensation Costs and Total Costs
    To calculate the compensation costs for each provider, we are 
proposing to then sum each of the costs estimated in steps (1) through 
(5) to derive total compensation costs for CHC, RHC, IRC, and GIP. We 
are proposing that total costs for CHC are equal to Worksheet B, column 
18, line 50, for RHC are equal to Worksheet B, column 18, line 51, for 
IRC would be equal to Worksheet B, column 18, line 52, and for GIP are 
equal to Worksheet B, column 18, line 53.
2. Proposed Methodology for Deriving Compensation Cost Weights
    To derive the compensation cost weights for each level of care, we 
first are proposing to begin with a sample of providers who met new 
Level I edit conditions that required freestanding hospices to fill out 
certain parts of their cost reports effective for freestanding hospice 
cost reports with a reporting period that ended on or after December 
31, 2017.\19\ Specifically, we required the following costs to be 
greater than zero: Fixed capital costs (Worksheet B, column 0, line 1), 
movable capital costs (Worksheet B, column 0, line 2), employee 
benefits (Worksheet B, column 0, line 3), administrative and general 
(Worksheet B, column 0, line 4), volunteer service coordination 
(Worksheet B, column 0, line 13), pharmacy and drugs charged to 
patients (sum of Worksheet B, column 0, line 14 and Worksheet A, column 
7, line 42.50), registered nurse costs (Worksheet A, column 7, line 
28), medical social service costs (Worksheet A, column 7, line 33), 
hospice aide and homemaker services costs (Worksheet A, column 7, line 
37), and durable medical equipment (Worksheet A, column 7, line 38). 
Applying these Level I edits to the 2018 freestanding hospice MCRs 
resulted in 3,345 providers that passed the edits (four were excluded).
---------------------------------------------------------------------------

    \19\ Medicare Department of Health and Human Services (DHHS) 
Provider Reimbursement Manual--Part 2, Provider Cost Reporting Forms 
and Instructions, Chapter 43, Form CMS-1984-14. April 13, 2018. 
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3P243.pdf.
---------------------------------------------------------------------------

    Then, for each level of care separately, we are proposing to 
further trim the sample of MCRs. We outline our proposed trimming 
methodology using CHC as an example. Specifically, for CHC, we propose 
that total CHC costs (Worksheet B, column 18, line 50) and CHC 
compensation costs to be greater than zero. We also propose that CHC 
direct patient care salaries and contract labor costs per day would be 
greater

[[Page 19719]]

than 1. We also propose to exclude those providers whose CHC 
compensation costs were greater than total CHC costs.
    For the IRC and GIP compensation cost weights, we are proposing to 
only use those MCRs from providers that provided inpatient services in 
their facility. Therefore, we are proposing to exclude providers that 
reported costs greater than zero on Worksheet A-3, column 7, line 25 
(Inpatient Care--Contracted) for IRC and Worksheet A-4, column 7, line 
25 (Inpatient Care--Contracted) for GIP. The facilities that remained 
after this trim reported detailed direct patient care costs and other 
patient care costs for which we could then derive direct patient care 
salaries and other patient care salaries per the methodology described 
earlier. This additional trim resulted in a sample that consists of 
approximately 20 percent of IRP providers and 28 percent of GIP 
providers that passed both the Level I edits and the trims that 
required total costs and compensation costs to be greater than zero, 
and direct patient care salaries and contract labor costs per day to be 
greater than 1, as well as total costs to be greater than compensation 
costs.
    Finally, to derive the proposed compensation cost weights for each 
level of care for each provider, we are proposing to divide 
compensation costs for each level of care by total costs for each level 
of care. We are proposing to then trim the data for each level of care 
separately to remove outliers. Following our example for CHC, we are 
proposing to simultaneously remove those providers whose total CHC 
costs per day fall in the top and bottom one percent of total CHC costs 
per day for all CHC providers as well remove those providers whose 
compensation cost weight falls in the top and bottom five percent of 
compensation cost weights for all CHC providers. We then sum the CHC 
compensation costs and total CHC costs of the remaining providers, 
yielding a proposed compensation cost weight for CHC.
    Since we have to limit our sample for IRC and GIP compensation cost 
weights to those hospices providing inpatient services in their 
facility, we conducted sensitivity analysis to test for the 
representative of this sample by reweighting compensation cost weights 
using data from the universe of freestanding providers that reported 
either IRC or GIP total costs. For example, we calculated reweighted 
compensation cost weights by ownership-type (proprietary, government 
and nonprofit), by size (based on RHC days) and by region. Our 
reweighted compensation cost weights for IRC and GIP were similar (less 
than one percentage point in absolute terms) to our proposed 
compensation cost weights for IRC and GIP (as shown in Table 11) and, 
therefore, we believe our sample is representative of freestanding 
hospices providing inpatient hospice care.
    Table 11 provides the proposed labor share for each level of care 
based on the compensation cost weights we derived using our proposed 
methodology described previously. We are proposing the labor shares be 
equal to three decimal places consistent with the labor shares used in 
other Prospective Payment Systems (PPS) (such as the inpatient 
prospective payment system (IPPS) and the Home Health Agency PPS). We 
invite comments on our proposed methodology to derive the labor shares 
for each level of care.
[GRAPHIC] [TIFF OMITTED] TP14AP21.016

C. Proposed Routine FY 2022 Hospice Wage Index and Rate Update

1. Proposed FY 2022 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: https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf). In 
OMB Bulletin No. 20-01, OMB announced one new Micropolitan Statistical 
Area, one new component of an existing Combined Statistical Are 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 have 
determined that the changes in Bulletin 20-01 encompassed delineation 
changes

[[Page 19720]]

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. Therefore, while we are proposing to adopt the updates set forth 
in OMB Bulletin No. 20-01 consistent with our longstanding policy of 
adopting OMB delineation updates, we note that specific wage index 
updates would not be necessary for FY 2022 as a result of adopting 
these OMB updates. In other words, these OMB updates would not affect 
any geographic areas for purposes of the wage index calculation for FY 
2022.
    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 finalized the proposal to adopt 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). For FY 2022, the 
proposed hospice wage index would be based on the FY 2022 hospital pre-
floor, pre-reclassified wage index for hospital cost reporting periods 
beginning on or after October 1, 2017 and before October 1, 2018 (FY 
2018 cost report data). The proposed FY 2022 hospice wage index would 
not include a cap on wage index decreases and would not take into 
account any geographic reclassification of hospitals, including those 
in accordance with section 1886(d)(8)(B) or 1886(d)(10) of the Act. The 
appropriate wage index value is 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 of 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 2022, the only CBSA without a hospital from which hospital wage 
data can be derived is 25980, Hinesville-Fort Stewart, Georgia. The FY 
2022 adjusted wage index value for Hinesville-Fort Stewart, Georgia is 
0.8649.
    There exist some geographic 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 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 
to one another of almost all of Puerto Rico's various urban and non-
urban areas, this methodology would produce a wage index for rural 
Puerto Rico that is higher than that in half of its urban areas); 
instead, we would continue to use the most recent wage index previously 
available for that area. For FY 2022, we propose to continue to use 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 adjusted pre-floor, pre-reclassified hospital 
wage index values below 0.8 will be further adjusted by a 15 percent 
increase subject to a maximum wage index value of 0.8. For example, if 
County A has a pre-floor, pre-reclassified hospital wage index value of 
0.3994, we would multiply 0.3994 by 1.15, which equals 0.4593. Since 
0.4593 is not greater than 0.8, then County A's hospice wage index 
would be 0.4593. In another example, if County B has a pre-floor, pre-
reclassified hospital wage index value of 0.7440, we would multiply 
0.7440 by 1.15, which equals 0.8556. Because 0.8556 is greater than 
0.8, County B's hospice wage index would be 0.8. The proposed hospice 
wage index applicable for FY 2022 (October 1, 2021 through September 
30, 2022) is available on our website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index.html.
2. Proposed FY 2022 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 market 
basket percentage increase for that FY. CMS currently uses 2014-based 
IPPS operating and capital market baskets to update the market basket 
percentage. In the FY 2022 IPPS proposed rule \20\ CMS is proposing to 
rebase and revise the IPPS market baskets to reflect a 2018 base year. 
We refer stakeholders to the FY 2022 IPPS proposed rule for further 
information.
---------------------------------------------------------------------------

    \20\ IPPS Regulations and Notices. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/IPPS-Regulations-and-Notices.
---------------------------------------------------------------------------

    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).
    The proposed hospice payment update percentage for FY 2022 is based 
on the current estimate of the proposed inpatient hospital market 
basket update of 2.5 percent (based on IHS Global Inc.'s fourth-quarter 
2020 forecast with historical data through the third quarter 2020). 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 update

[[Page 19721]]

for FY 2022 of 2.5 percent must be reduced by a MFP adjustment as 
mandated by Affordable Care Act (currently estimated to be 0.2 
percentage points for FY 2022). In effect, the proposed hospice payment 
update percentage for FY 2022 would be 2.3 percent. If more recent data 
becomes available after the publication of this proposed rule and 
before the publication of the final rule (for example, more recent 
estimates of the inpatient hospital market basket update and MFP 
adjustment), we would use such data, if appropriate, to determine the 
hospice payment update percentage for FY 2022 in the final rule.
    Currently, the labor portion of the hospice payment rates are as 
follows: For RHC, 68.71 percent; for CHC, 68.71 percent; for GIP, 64.01 
percent; and for IRC, 54.13 percent. As discussed in section III.B of 
this proposed rule, we are proposing to rebase and revise the labor 
shares for RHC, CHC, GIP and IRC using MCR data for freestanding 
hospices (CMS Form 1984-14, OMB Control Number 0938-0758) for 2018. We 
are proposing the labor portion of the payment rates to be: For RHC, 
64.7 percent; for CHC, 74.6 percent; for GIP, 62.8 percent; and for 
IRC, 60.1 percent. The non-labor portion is equal to 100 percent minus 
the labor portion for each level of care. Therefore, we are proposing 
the non-labor portion of the payment rates to be as follows: For RHC, 
35.3 percent; for CHC, 25.4 percent; for GIP, 37.2 percent; and for 
IRC, 39.9 percent.
3. Proposed FY 2022 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 is to treat symptoms that cannot be managed in another setting.
    As discussed in the FY 2016 Hospice Wage Index and Rate Update 
final rule (80 FR 47172), we implemented two different RHC payment 
rates, one RHC rate for the first 60 days and a second RHC rate for 
days 61 and beyond. In addition, in that final rule, we implemented a 
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. In order 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. Typically, the wage index 
standardization factor is calculated using the most recent, complete 
hospice claims data available. However, due to the COVID-19 PHE, we 
looked at using the previous fiscal year's hospice claims data (FY 
2019) to determine if there were significant differences between 
utilizing 2019 and 2020 claims data. The difference between using FY 
2019 and FY 2020 hospice claims data was minimal. Therefore, we will 
continue our practice of using the most recent, complete hospice claims 
data available; that is we are using FY 2020 claims data for the FY 
2022 payment rate updates. In order to calculate the wage index 
standardization factor, we simulate total payments using FY 2020 
hospice utilization claims data with the FY 2021 wage index (pre-floor, 
pre-reclassified hospital wage index with the hospice floor, and a 5 
percent cap on wage index decreases) and FY 2021 payment rates (that 
include the current labor shares) and compare it to our simulation of 
total payments using the FY 2022 hospice wage index (with hospice 
floor, without the 5 percent cap on wage index decreases) and FY 2021 
payment rates (that include the current labor shares). By dividing 
payments for each level of care (RHC days 1 through 60, RHC days 61+, 
CHC, IRC, and GIP) using the FY 2021 wage index and payment rates for 
each level of care by the FY 2022 wage index and FY 2021 payment rates, 
we obtain a wage index standardization factor for each level of care. 
In order to calculate the labor share standardization factor we 
simulate total payments using FY 2020 hospice utilization claims data 
with the FY 2022 hospice wage index and the current labor shares and 
compare it to our simulation of total payments using the FY 2022 
hospice wage index with the proposed revised labor shares. The wage 
index and labor share standardization factors for each level of care 
are shown in the Tables 12 and 13.
    The proposed FY 2022 RHC rates are shown in Table 12. The proposed 
FY 2022 payment rates for CHC, IRC, and GIP are shown in Table 13. 
[GRAPHIC] [TIFF OMITTED] TP14AP21.017


[[Page 19722]]


[GRAPHIC] [TIFF OMITTED] TP14AP21.018

    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 that quality data in 2013. Section 
1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014 and 
each subsequent FY, 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. The 
proposed FY 2022 rates for hospices that do not submit the required 
quality data would be updated by the proposed FY 2022 hospice payment 
update percentage of 2.3 percent minus 2 percentage points. These rates 
are shown in Tables 14 and 15. 
[GRAPHIC] [TIFF OMITTED] TP14AP21.019


[[Page 19723]]


[GRAPHIC] [TIFF OMITTED] TP14AP21.020

4. Proposed Hospice Cap Amount for FY 2022
    As discussed in the FY 2016 Hospice Wage Index and Rate Update 
final rule (80 FR 47183), we implemented changes mandated by the IMPACT 
Act of 2014 (Pub. L. 113-185). 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 has extended the accounting years impacted by the adjustment 
made to the hospice cap calculation until 2030. Therefore, for 
accounting years that end after September 30, 2016 and before October 
1, 2030, the hospice cap amount is updated by the hospice payment 
update percentage rather than using the CPI-U. As a result of the 
changes mandated by Division CC, section 404 of the CAA 2021, 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 proposed hospice cap amount for the FY 2022 cap year will be 
$31,389.66, which is equal to the FY 2021 cap amount ($30,683.93) 
updated by the proposed FY 2022 hospice payment update percentage of 
2.3 percent.

D. Proposed Clarifying Regulation Text Changes for the Hospice Election 
Statement Addendum

    In the FY 2020 Hospice Wage Index and Payment Rate Update final 
rule (84 FR 38484), we finalized modifications to the hospice election 
statement content requirements at Sec.  418.24(b) to increase coverage 
transparency for patients under a hospice election. These changes 
included a new condition for payment requiring a hospice, upon request, 
to provide the beneficiary (or representative) an election statement 
addendum (hereafter called ``the addendum'') outlining the items, 
services, and drugs that the hospice has determined are unrelated to 
the terminal illness and related conditions. We stated in that final 
rule that the addendum is intended to complement the Hospice Conditions 
of Participation (CoPs) at Sec.  418.52(a), which require hospices to 
verbally inform beneficiaries, at the time of hospice election, of the 
services covered under the Medicare hospice benefit, as well as the 
limitations of such services (84 FR 38509). The requirements at 
Sec. Sec.  418.24(b) and 418.52(a) ensure that beneficiaries are aware 
of any items, services, or drugs they would have to seek outside of the 
benefit, as well as their potential out-of-pocket costs for hospice 
care, such as co-payments and/or coinsurance.
    Section 418.24(c) sets forth the elements that must be included on 
the addendum:
    1. The addendum must be titled ``Patient Notification of Hospice 
Non-Covered Items, Services, and Drugs'';
    2. Name of the hospice;
    3. Beneficiary's name and hospice medical record identifier;
    4. Identification of the beneficiary's terminal illness and related 
conditions;
    5. A list of the beneficiary's current diagnoses/conditions present 
on hospice admission (or upon plan of care update, as applicable) and 
the associated items, services, and drugs, not covered by the hospice 
because they have been determined by the hospice to be unrelated to the 
terminal illness and related conditions;
    6. A written clinical explanation, in language the beneficiary and 
his or her representative can understand, as to why the identified 
conditions, items, services, and drugs are considered unrelated to the 
terminal illness and related conditions and not needed for pain or 
symptom management. This clinical explanation must be accompanied by a 
general statement that the decision as to what conditions, items, 
services, or drugs are unrelated is made for each individual patient, 
and that the beneficiary should share this clinical explanation with 
other health care providers from which he or she seeks services 
unrelated to his or her terminal illness and related conditions;
    7. References to any relevant clinical practice, policy, or 
coverage guidelines;
    8. Information on the following:

a. Purpose of the addendum
b. patient's right to immediate advocacy

    9. Name and signature of the Medicare hospice beneficiary (or 
representative) and date signed, along with a statement that signing 
this addendum (or its updates) is only acknowledgement of receipt of 
the addendum (or its updates) and not necessarily the beneficiary's 
agreement with the hospice's determinations.
    The hospice is required to furnish the addendum in writing in an 
accessible format,\23\ so the beneficiary (or representative) can 
understand the information provided, make treatment decisions based on 
that information, and share such information with non-hospice providers 
rendering un-related items and services to the beneficiary. Therefore, 
the format of the addendum

[[Page 19724]]

must be usable for the beneficiary and/or representative. Although we 
stated in the FY 2020 Hospice Wage Index and Payment Rate Update that 
hospices may develop their own election statement addendum (84 FR 
38507), we posted a modified model election statement and addendum on 
the Hospice Center web page,\21\ along with the publication of the FY 
2021 Hospice Wage Index and Payment Rate Update final rule (85 FR 
47070). The intent was to provide an illustrative example as hospices 
can modify and develop their own forms to meet the content 
requirements. In the FY 2021 Hospice Wage Index and Payment Rate Update 
final rule, we stated that most often we would expect the addendum 
would be in a hard copy format the beneficiary or representative can 
keep for his or her own records, similar to how hospices are required 
by the hospice CoPs at Sec.  418.52(a)(3) to provide the individual a 
copy of the notice of patient rights and responsibilities (85 FR 
47091). The hospice CoPs at Sec.  418.104(a)(2) state that the 
patient's record must include ``signed copies of the notice of patient 
rights in accordance with Sec.  418.52.'' Likewise, since the addendum 
is part of the election statement as set forth in Sec.  418.24(b)(6), 
then it is required to be part of the patient's record (if requested by 
the beneficiary or representative). The signed addendum is only 
acknowledgement of the beneficiary's (or representative's) receipt of 
the addendum (or its updates) and the payment requirement is considered 
met if there is a signed addendum (and any signed updates) in the 
requesting beneficiary's medical record with the hospice. We believe 
that a signed addendum connotes that the hospice discussed the addendum 
and its contents with the beneficiary (or representative). 
Additionally, in the event that a beneficiary (or representative) does 
not request the addendum, we expect hospices to document, in some 
fashion, that an addendum has been discussed with the patient (or 
representative) at the time of election, similar to how other patient 
and family discussions are documented in the hospice's clinical record. 
It is necessary for the hospice to document that the addendum was 
discussed and whether or not it was requested, in order to prevent 
potential claims denials related to any absence of an addendum (or 
addendum updates) in the medical record.
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    \23\ English and Spanish Version of the Hospice Addendum Model. 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice.
    \21\ Hospice Center web page. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/index.
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    Though we did not propose any changes to the election statement 
addendum content requirements at Sec.  418.24(c), or the October 1, 
2020 effective date, in the FY 2021 Hospice Wage Index and Payment Rate 
Update proposed rule, we solicited comments on the usefulness of the 
modified model election statement and addendum posted on the Hospice 
Center web page (85 FR 20949). In the FY 2021 Hospice Wage Index and 
Payment Rate Update final rule (85 FR 47093), we responded to comments 
received, and stated that, as finalized in the FY 2020 Hospice Wage 
Index and Payment Rate Update final rule, the hospice election 
statement addendum will remain a condition for payment that is met when 
there is a signed addendum (and its updates) in the beneficiary's 
hospice medical record.
    Since its implementation on October 1, 2020, CMS has received 
additional inquiries from stakeholders asking for clarification on 
certain aspects of the addendum. We appreciate and understand the 
importance of provider input and involvement in ensuring that this 
document is effective in increasing coverage transparency for 
beneficiaries. Therefore, we are providing clarification on, and 
proposing modifications to, certain signature and timing requirements 
and proposing corresponding clarifying regulations text changes.
    Currently the regulations at Sec.  418.24(c) require that if a 
beneficiary or his or her representative requests the addendum at the 
time of the initial hospice election (that is, at the time of admission 
to hospice), the hospice must provide this information, in writing, to 
the individual (or representative) within 5 days from the date of the 
election. Hospices have reported that beneficiaries or representatives 
sometimes do not request the addendum at the time of election, but 
rather within the 5 days after the effective date of the election. In 
these situations, the regulations require the hospice to provide the 
addendum within 3 days, as the beneficiary requested the addendum 
during the course of care. However, in accordance with Sec.  418.54(b), 
the hospice interdisciplinary group (IDG), in consultation with the 
individual's attending physician (if any), must complete the hospice 
comprehensive assessment no later than 5 calendar days after the 
election of hospice care. In some instances, this may mean that the 
hospice must furnish the addendum prior to completion of the 
comprehensive assessment. The comprehensive assessment includes all 
areas of hospice care related to the palliation and management of a 
beneficiary's terminal illness. This assessment is necessary because it 
provides an overview of the items, services and drugs that the patient 
is already utilizing as well as helps determine what the hospice may 
need to add in order to treat the patient throughout the dying process. 
If the addendum is completed prior to the comprehensive assessment, the 
hospice may not have a complete patient profile, which could 
potentially result in the hospice incorrectly anticipating the extent 
of covered and non-covered services and lead to an inaccurate election 
statement addendum. Hospice providers are only able to discern what 
items, services, and drugs they will not cover once they have a 
beneficiary's comprehensive assessment. We are proposing to allow the 
hospice to furnish the addendum within 5 days from the date of a 
beneficiary or representative request, if the request is within 5 days 
from the date of a hospice election. For example, if the patient elects 
hospice on December 1st and requests the addendum on December 3rd, the 
hospice would have until December 8th to furnish the addendum.
    Additionally, hospices have noted that there is not a timeframe in 
regulations regarding the patient signature on the addendum. Section 
418.24(c)(9) requires the beneficiary's signature (or his/her 
representative's signature) as well as the date the document was 
signed. We noted in the FY 2021 Hospice Wage Index & Payment Rate 
Update final rule that because the beneficiary signature is an 
acknowledgement of receipt of the addendum, this means the beneficiary 
would sign the addendum when the hospice provides it, in writing, to 
the beneficiary or representative (85 FR 47092). Additionally, 
obtaining the required signatures on the election statement has been a 
longstanding regulatory requirement. Therefore, we expect that hospices 
already have processes and procedures in place to ensure that required 
signatures are obtained, either from the beneficiary, or from the 
representative in the event the beneficiary is unable to sign. We 
anticipate that hospices would use the same procedures for obtaining 
signatures on the addendum. However, we understand that some 
beneficiaries or representatives may request an emailed addendum or 
request more time to review the addendum before signing, in which case 
the date that the hospice furnished the addendum to the beneficiary (or 
representative) may differ from the date that the beneficiary

[[Page 19725]]

or representative signs the addendum. This means the hospice may 
furnish the addendum within the required timeframe; however, the 
signature date may be beyond the required timeframe. Therefore, we 
propose to clarify in regulation that the ``date furnished'' must be 
within the required timeframe (that is, 3 or 5 days of the beneficiary 
or representative request, depending on when such request was made), 
rather than the signature date. At Sec.  418.24(c)(10), we propose that 
the hospice would include the ``date furnished'' in the patient's 
medical record and on the addendum itself.
    In the FY 2021 Hospice Wage Index and Payment Rate Update final 
rule, we addressed a concern regarding a potential situation wherein 
the beneficiary or representative refuses to sign the addendum (85 FR 
47088). We reiterated that the signature on the addendum is only 
acknowledgement of receipt and not a tacit agreement of its contents, 
and that we expect the hospice to inform the beneficiary of the purpose 
of the addendum and rationale for the signature. However, we recognized 
that there might be rare instances in which the beneficiary (or 
representative) refuses to sign the addendum. We noted that we would 
consider whether this issue would require future rulemaking. We have 
subsequently received this question from stakeholders post 
implementation, therefore, in this proposed rule, we are clarifying 
that if a patient or representative refuses to sign the addendum, the 
hospice must document clearly in the medical record (and on the 
addendum itself) the reason the addendum is not signed in order to 
mitigate a claims denial for this condition for payment. In such a 
case, although the beneficiary has refused to sign the addendum, the 
``date furnished'' must still be within the required timeframe (that 
is, within 3 or 5 days of the beneficiary or representative request, 
depending on when such request was made), and noted in the chart and on 
the addendum itself.
    Stakeholders again requested that CMS clarify whether a non-hospice 
provider is required to sign the addendum in the event that the non-
hospice provider requests the addendum rather than the beneficiary or 
representative. Therefore, if only a non-hospice provider or Medicare 
contractor requests the addendum (and not the beneficiary or 
representative) we would not expect a signed copy in the patient's 
medical record. Hospices can develop processes (including how to 
document such requests from non-hospice providers and Medicare 
contractors) to address circumstances in which the non-hospice provider 
or Medicare contractor requests the addendum, and the beneficiary or 
representative does not. As such, we are proposing to clarify in 
regulation that if a non-hospice provider requests the addendum, rather 
than the beneficiary or representative, the non-hospice provider is not 
required to sign the addendum.
    There may be instances in which the beneficiary or representative 
requests the addendum and the beneficiary dies, revokes, or is 
discharged prior to signing the addendum. While we stated in the FY 
2020 Hospice Wage Index and Payment Rate Update final rule, that if the 
beneficiary requests the election statement addendum at the time of 
hospice election but dies within 5 days, the hospice would not be 
required to furnish the addendum as the requirement would be deemed as 
being met in this circumstance (84 FR 38521), this policy was not 
codified in regulation. Therefore, we are proposing conforming 
regulations text changes at Sec.  418.24(c) to reflect this policy. 
Furthermore, we propose to clarify at Sec.  418.24(d)(4) that if the 
patient revokes or is discharged within the required timeframe (3 or 5 
days after a request, depending upon when such request was made), but 
the hospice has not yet furnished the addendum, the hospice is not 
required to furnish the addendum. Similarly, we are proposing to 
clarify at Sec.  418.24(d)(5) that in the event that a beneficiary 
requests the addendum and the hospice furnishes the addendum within 3 
or 5 days (depending upon when the request for the addendum was made), 
but the beneficiary dies, revokes, or is discharged prior to signing 
the addendum, a signature from the individual (or representative) is no 
longer required. We would continue to expect that the hospice would 
note the date furnished in the patient's medical record and on the 
addendum, if the hospice has already completed the addendum, as well as 
an explanation in the patient's medical record noting that the patient 
died, revoked, or was discharged prior to signing the addendum.
    Finally, we are proposing conforming regulations text changes at 
Sec.  418.24(c) in alignment with subregulatory guidance indicating 
that hospices have ``3 days,'' rather than ``72 hours'' to meet the 
requirement when a patient requests the addendum during the course of a 
hospice election. Hospices must furnish the addendum no later than 3 
calendar days after a beneficiary's (or representative's) request 
during the course of a hospice election. This means that hospice 
providers must furnish the addendum to the beneficiary or 
representative on or before the third day after the date of the 
request. For example, if a beneficiary (or representative) requests the 
addendum on February 22nd, then the hospice will have until February 
25th to furnish the addendum, regardless of what time the addendum was 
requested on February 22nd. The intent of this clarification is to 
better align with the requirement for furnishing an election statement 
addendum when the addendum is requested within 5 days of the date of 
election, which also uses ``days'' rather than ``hours''.
    We are soliciting comments on these proposed clarifications and 
conforming regulation text changes.

E. Hospice Waivers Made Permanent Conditions of Participation

1. Background
    In order to support provider and supplier communities due to the 
COVID-19 PHE, CMS has issued an unprecedented number of regulatory 
waivers under our statutory authority set forth at section 1135 of the 
Act. Under section 1135 of the Act, the Secretary may temporarily waive 
or modify certain Medicare, Medicaid, and Children's Health Insurance 
Program (CHIP) requirements to ensure that sufficient health care items 
and services are available to meet the needs of individuals enrolled in 
the programs in the emergency area and time periods, and that providers 
who furnish such services in good faith, but who are unable to comply 
with one or more requirements as described under section 1135(b) of the 
Act, can be reimbursed and exempted from sanctions for violations of 
waived provisions (absent any determination of fraud or abuse). The 
intent of these waivers was to expand healthcare system capacity while 
continuing to maintain public and patient safety, and to hold harmless 
providers and suppliers unable to comply with existing regulations 
after a good faith effort.
    While some of these waivers simply delay certain administrative 
deadlines, others directly affect the provision of patient care. The 
utilization and application of these waivers pushed us to consider 
whether permanent changes would be beneficial to patients, providers, 
and professionals. We identified selected waivers as appropriate 
candidates for formal regulatory changes. Those proposed changes and 
their respective histories and background information are discussed in 
detail in section II. E of this rule. We are also proposing regulatory

[[Page 19726]]

changes that are not directly related to PHE waivers but would clarify 
or align some policies that have been raised as concerns by 
stakeholders.
    We are proposing the following revisions to the hospice Conditions 
of Participation (CoPs).
2. Hospice Aide Training and Evaluation--Using Pseudo-Patients
    Hospice aides deliver a significant portion of direct care. Aides 
are usually trained by an employer, such as a hospice, home health 
agency (HHA) or nursing home and may already be certified as an aide 
prior to being hired. The competency of new aides must be evaluated by 
the hospice to ensure appropriate care can be provided by the aide. 
Aide competency evaluations should be conducted in a way that 
identifies and meets training needs of the aide as well as the 
patient's needs. These evaluations are a critical part of providing 
safe, quality care. In September of 2019, we published a final rule 
that allows the use of the pseudo-patient for conducting home health 
aide competency evaluations (``Medicare and Medicaid Programs; 
Regulatory Provisions To Promote Program Efficiency, Transparency, and 
Burden Reduction; Fire Safety Requirements for Certain Dialysis 
Facilities; Hospital and Critical Access Hospital (CAH) Changes To 
Promote Innovation, Flexibility, and Improvement in Patient Care'' (84 
FR 51732)). The ability to use pseudo-patients during aide competency 
evaluations allows greater flexibility and may reduce burden on 
suppliers. We believe that hospices and their patients would also 
benefit from the ability to use pseudo-patients in aide training.
    The current hospice aide competency standard regulations at Sec.  
418.76(c)(1) requires the aide to be evaluated by observing an aide's 
performance of the task with a patient. We propose to make similar 
changes to hospice aide competency standards to those already made with 
respect to HHAs (see Sec.  484.80(c)) in our hospice regulations at 
Sec.  418.76(c)(1)), which describes the process for conducting hospice 
aide competency evaluations, and propose to define both ``pseudo-
patient'' and ``simulation'' at Sec.  418.3. Thus, we are proposing to 
permit skill competencies to be assessed by observing an aide 
performing the skill with either a patient or a pseudo-patient as part 
of a simulation. The proposed definitions are as follows:
     ``Pseudo-patient'' means a person trained to participate 
in a role-play situation, or a computer-based mannequin device. A 
pseudo-patient must be capable of responding to and interacting with 
the hospice aide trainee, and must demonstrate the general 
characteristics of the primary patient population served by the hospice 
in key areas such as age, frailty, functional status, cognitive status 
and care goals.
     ``Simulation'' means a training and assessment technique 
that mimics the reality of the homecare environment, including 
environmental distractions and constraints that evoke or replicate 
substantial aspects of the real world in a fully interactive fashion, 
in order to teach and assess proficiency in performing skills, and to 
promote decision making and critical thinking.
    These proposed changes would allow hospices to utilize pseudo-
patients, such as a person trained to participate in a role-play 
situation or a computer-based mannequin device, instead of actual 
patients, in the competency testing of hospice aides for those tasks 
that must be observed being performed on a patient. This could increase 
the speed of performing competency testing and would allow new aides to 
begin serving patients more quickly while still protecting patient 
health and safety.
3. Hospice Aid Training and Evaluation--Targeting Correction of 
Deficiencies
    We are also proposing to amend the requirement at Sec.  
418.76(h)(1)(iii) to specify that if an area of concern is verified by 
the hospice during the on-site visit, then the hospice must conduct, 
and the hospice aide must complete, a competency evaluation of the 
deficient skill and all related skill(s) in accordance with Sec.  
418.76(c). This proposed change would permit the hospice to focus on 
the hospice aides' specific deficient and related skill(s) instead of 
completing another full competency evaluation. We believe when a 
deficient area(s) in the aide's care is assessed by the RN, there may 
be additional related competencies that may also lead to additional 
deficient practice areas. For example, if a patient's family informed 
the nurse that the patient almost fell when the aide was transferring 
the patient to a chair; the nurse could assess the aide's transferring 
technique to determine whether there was any improper form. The hospice 
must also conduct, and the hospice aide must complete, a competency 
evaluation related to the deficient and related transferring skills; 
such as transferring from bed to bedside commode or shower chair.
    We request public comment on our proposed changes to allow for the 
use of the pseudo patient for conducting hospice aide competency 
testing, and the proposed change to allow the hospice to focus on the 
hospice aides' specific deficient skill(s) instead of completing a full 
competency evaluation. We especially welcome comments from hospices 
that implemented the use of pseudo-patients during the COVID-19 PHE and 
the additional proposal, that if an area of concern is verified by the 
hospice during the on-site visit, then the hospice must conduct, and 
the hospice aide must complete, a competency evaluation related to the 
deficient and related skill(s).

F. Proposals and Updates to the Hospice Quality Reporting Program

1. Background and Statutory Authority
    The Hospice Quality Reporting Program (HQRP) specifies reporting 
requirements for both the Hospice Item Set (HIS) 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 (Pub. L. 116-260) 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 FY 2024 annual payment update (APU). Specifically, the 
Act requires that, beginning with 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.
    In addition, section 407(a)(2) of the CAA 2021 removes the 
prohibition on public disclosure of hospice surveys performed be a 
national accreditation agency in section 1865(b) of the Act, thus 
allowing the Secretary to disclose such accreditation surveys. In 
addition, section 407(a)(1) of the CAA 2021 adds new requirements in 
newly added section 1822(a)(2) to require each state and local survey 
agency, and each national accreditation body with an approved hospice 
accreditation program, to submit information respecting any survey or 
certification made with respect to a hospice program. Such information 
shall include any inspection report made by such survey agency or body 
with respect to such survey or certification, any enforcement

[[Page 19727]]

actions taken as a result of such survey or certification, and any 
other information determined appropriate by the Secretary. This 
information will be published publicly on our website, such as Care 
Compare, in a manner that is easily accessible, readily understandable, 
and searchable no later than October 1, 2022. In addition, national 
accreditation bodies with approved hospice accreditation programs 
described above are required to use the same survey form used by state 
and local survey agencies, which is currently the Form CMS-2567, on or 
after October 1, 2021.
    Depending on the amount of the annual update for a particular year, 
a reduction of 2 percentage points through FY 2023 or 4 percentage 
points beginning in FY 2024 could result in the annual market basket 
update being less than zero percent for a FY and may result in payment 
rates that are less than payment rates for the preceding FY. Any 
reduction based on failure to comply with the reporting requirements, 
as required by section 1814(i)(5)(B) of the Act, would apply only for 
the specified year. Any such reduction would not be cumulative nor be 
taken into account in computing the payment amount for subsequent FYs.
    Section 1814(i)(5)(C) of the Act requires that each hospice submit 
data to the Secretary on quality measures specified by the Secretary. 
The data must be submitted in a form, manner, and at a time specified 
by the Secretary. Any measures selected by the Secretary must have been 
endorsed by the consensus-based entity which holds a performance 
measurement contract with the Secretary under section 1890(a) of the 
Act. This contract is currently held by the National Quality Forum 
(NQF). However, section 1814(i)(5)(D)(ii) of the Act provides that in 
the case of a specified area or medical topic determined appropriate by 
the Secretary for which a feasible and practical measure has not been 
endorsed by the consensus-based entity, the Secretary may specify 
measures that are not endorsed, as long as due consideration is given 
to measures that have been endorsed or adopted by a consensus-based 
organization identified by the Secretary. Section 1814(i)(5)(D)(iii) of 
the Act requires that the Secretary publish selected measures 
applicable with respect to FY 2014 no later than October 1, 2012.
    In the FY 2014 Hospice Wage Index and Payment Rate Update final 
rule (78 FR 48234), and in compliance with section 1814(i)(5)(C) of the 
Act, we finalized the specific collection of data items that support 
the seven NQF-endorsed hospice measures described in Table 1. In 
addition, we finalized the Hospice Visits When Death is Imminent 
measure pair (HVWDII, Measure 1 and Measure 2) in the FY 2017 Hospice 
Wage Index and Payment Rate Update final rule, effective April 1, 2017. 
We refer the public to the FY 2017 Hospice Wage Index and Payment Rate 
Update final rule (81 FR 52144) for a detailed discussion.
    The CAHPS Hospice Survey is a component of the CMS HQRP, which is 
used to collect data on the experiences of hospice patients and their 
family caregivers listed in their hospice records. Readers who want 
more information about the development of the survey, originally called 
the Hospice Experience of Care Survey, may refer to 79 FR 50452 and 78 
FR 48261. National implementation of the CAHPS Hospice Survey commenced 
January 1, 2015, as stated in the FY 2015 Hospice Wage Index and 
Payment Rate Update final rule (79 FR 50452).
    The CAHPS Hospice Survey measures received NQF endorsement on 
October 26, 2016 and was re-endorsed November 20, 2020 (NQF #2651). NQF 
endorsed six composite measures and two overall measures from the CAHPS 
Hospice Survey. Along with nine HIS-based quality measures, the CAHPS 
Hospice Survey measures are publicly reported on a designated CMS 
website that is currently Care Compare. Table 16 lists all quality 
measures currently adopted for the HQRP.
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[[Page 19729]]


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BILLING CODE 4120-01-C
    The Hospice and Palliative Care Composite Process Measure--HIS-
Comprehensive Assessment at Admission measure (hereafter referred to as 
``the HIS Comprehensive Assessment Measure'') underwent an off-cycle 
review by the NQF Palliative and End-of-Life Standing Committee and 
successfully received NQF endorsement in July 2017 (NQF 3235). The HIS 
Comprehensive Assessment Measure captures whether multiple key care 
processes were delivered upon patients' admissions to hospice in one 
measure as described in the Table 1. NQF 3235 does not require NQF's 
endorsements of the previous components to remain valid. Thus, if the 
components included in NQF 3235 do not individually maintain 
endorsement, the endorsement status of NQF 3235, as a single measure, 
will not change.
    In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 
47142), we finalized the policy for retention of HQRP measures adopted 
for previous payment determinations and seven factors for measure 
removal. In that same final rule, we discussed that we will issue 
public notice, through rulemaking, of measures under consideration for 
removal, suspension, or replacement. However, if there is reason to 
believe continued collection of a measure raises potential safety 
concerns, we will take immediate action to remove the measure from the 
HQRP and will not wait for the annual rulemaking cycle. Such measures 
will be promptly removed and we will immediately notify hospices and 
the public of our decision through the usual HQRP communication 
channels, including but not limited to listening sessions, email 
notification, Open Door Forums, HQRP Forums, and Web postings. In such 
instances, the removal of a measure will be formally announced in the 
next annual rulemaking cycle.
    In the FY 2019 Hospice Wage Index and Rate Update final rule (83 FR 
38622), we also adopted an eighth factor for removal of a measure. This 
factor aims to promote improved health outcomes for beneficiaries while 
minimizing the overall costs associated with the program. These costs 
are multifaceted and include the burden associated with complying with 
the program. The finalized reasons for removing quality measures are:
    1. Measure performance among hospices is so high and unvarying that 
meaningful distinctions in improvements in performance can no longer be 
made;
    2. Performance or improvement on a measure does not result in 
better patient outcomes;
    3. A measure does not align with current clinical guidelines or 
practice;
    4. A more broadly applicable measure (across settings, populations, 
or conditions) for the particular topic is available;
    5. A measure that is more proximal in time to desired patient 
outcomes for the particular topic is available;
    6. A measure that is more strongly associated with desired patient 
outcomes for the particular topic is available;
    7. Collection or public reporting of a measure leads to negative 
unintended consequences; or
    8. The costs associated with a measure outweighs the benefit of its 
continued use in the program.
    On August 31, 2020, we added correcting language to the FY 2016 
Hospice Wage Index and Payment Rate Update and Hospice Quality 
Reporting Requirements; Correcting Amendment (85 FR 53679) hereafter 
referred to as the FY 2021 HQRP Correcting Amendment. In this final 
rule, we made correcting amendments to 42 CFR 418.312 to correct 
technical errors

[[Page 19730]]

identified in the FY 2016 Hospice Wage Index and Payment Rate Update 
final rule. Specifically, the FY 2021 HQRP Correcting Amendment (85 FR 
53679) adds paragraph (i) to Sec.  418.312 to reflect our exemptions 
and extensions requirements, which were referenced in the preamble but 
inadvertently omitted from the regulations text. Thus, these exemptions 
or extensions can occur when a hospice encounters certain extraordinary 
circumstances.
    As stated in the FY 2019 Hospice Wage Index and Rate Update final 
rule (83 FR 38622), we launched the Meaningful Measures initiative 
(which identifies high priority areas for quality measurement and 
improvement) to improve outcomes for patients, their families, and 
providers while also reducing burden on clinicians and providers. More 
information about the Meaningful Measures initiative can be found at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
    In the FY 2020 Hospice Wage Index and Payment Rate Update final 
rule (84 FR 38484), we discussed our interest in developing quality 
measures using claims data, to expand data sources for quality measure 
development. While we acknowledged in that rule the limitations with 
using claims data as a source for measure development, there are 
several advantages to using claims data as part of a robust HQRP as 
discussed previously in the FY 2020 rule. We also discussed developing 
the Hospice Outcomes & Patient Evaluation (HOPE), a new patient 
assessment instrument that is planned to replace the HIS. See an update 
on HOPE development in section III.F.6, Update regarding the Hospice 
Outcomes & Patient Evaluation (HOPE) development.
    We also discussed our interest in outcome quality measure 
development. Unlike process measures, outcome measures capture the 
results of care as experienced by patients, which can include aspects 
of a patient's health status and their experiences in the health 
system. The portfolio of quality measures in the HQRP will include 
outcome measures that reflect the results of care.
2. Proposal To Remove the Seven ``Hospice Item Set Process Measures'' 
From HQRP Beginning FY 2022
    In the FY 2014 Hospice Wage Index and Payment Rate Update final 
rule (78 FR 48234), and in compliance with section 1814(i)(5)(C) of the 
Act, we finalized the specific collection of standardized data items, 
known as the HIS, that support the following NQF-endorsed measures:

 NQF #1617 Patients Treated with an Opioid who are Given a 
Bowel Regimen
 NQF #1634 Pain Screening
 NQF #1637 Pain Assessment
 NQF #1638 Dyspnea Treatment
 NQF #1639 Dyspnea Screening
 NQF #1641 Treatment Preferences
 NQF #1647 Beliefs/Values Addressed (if desired by the patient)

    These measures were adopted to increase public awareness of key 
components of hospice care, such as pain and symptom management and 
non-clinical care needs. Consistent with our policy for measure 
retention and removal, finalized in the FY 2016 Hospice Wage Index and 
Rate Update final rule (80 FR 47142), we reviewed these measures 
against the factors for removal. Our analysis found that they meet 
factor 4: ``A more broadly applicable measure (across settings, 
populations, or conditions) for the particular topic is available.'' We 
determined that the NQF #3235 HIS Comprehensive Assessment Measure, 
discussed in detail in the FY 2017 Hospice Wage Index and Payment Rate 
Update final rule (81 FR 52144), is a more broadly applicable measure 
and continues to provide, in a single measure, meaningful differences 
between hospices regarding overall quality in addressing the physical, 
psychosocial, and spiritual factors of hospice care upon admission.
    The HIS Comprehensive Assessment Measure's ``all or none'' 
criterion requires hospices to perform all seven care processes in 
order to receive credit. In this way, it is different from an average-
based composite measure and sets a higher bar for performance. This 
single measure differentiates hospices and holds them accountable for 
completing all seven process measures to ensure core services of the 
hospice comprehensive assessment are completed for all hospice 
patients. Therefore, the HIS Comprehensive Assessment Measure continues 
to encourage hospices to improve and maintain high performance in all 
seven processes simultaneously, rather than rely on its component 
measures to demonstrate quality hospice care in a way that may be hard 
to interpret for consumers. The individual measures show performance 
for only one process and do not demonstrate whether the hospice 
provides high-quality care overall, as an organization. For example, a 
hospice may perform extremely well assessing treatment preferences, but 
poorly on addressing pain. High-quality hospice care not only manages 
pain and symptoms of the terminal illness, but assesses non-clinical 
needs of the patient and family caregivers, which is a hallmark of 
patient-centered care. Since the HIS Comprehensive Assessment Measure 
captures all seven processes collectively, we believe that public 
display of the individual component measures are not necessary.
    The interdisciplinary, holistic scope of the NQF #3235 HIS 
Comprehensive Assessment Measure aligns with the public's expectations 
for hospice care. In addition, the measure supports alignment across 
our programs and with other public and private initiatives. The seven 
individual components address care processes around hospice admission 
that are clinically recommended or required in the hospice CoPs. The 
Medicare Hospice CoPs require that hospice comprehensive assessments 
identify patients' physical, psychosocial, emotional, and spiritual 
needs and address them to promote the hospice patient's comfort 
throughout the end-of-life process. Furthermore, the person-centered, 
family, and caregiver perspective align with the domains identified by 
the CoPs and the National Consensus Project \22\ as patients and their 
family caregivers also place value on physical symptom management and 
spiritual/psychosocial care as important factors at the end-of-life. 
The HIS Comprehensive Assessment Measure is a composite measure that 
serves to ensure all hospice patients receive a comprehensive 
assessment for both physical and psychosocial needs at admission.
---------------------------------------------------------------------------

    \22\ The National Consensus Project Guidelines expand on the 
eight domains of palliative care in the 3rd edition and include 
clinical and organizational strategies, screening and assessment 
elements, practice examples, tools and resources. The guidelines 
were developed by the National Consensus Project for Quality 
Palliative Care, comprising 16 national organizations with extensive 
expertise in and experience with palliative care and hospice, and 
were published by the National Coalition for Hospice and Palliative 
Care. Journal of Hospice & Palliative Nursing: December 2018--Volume 
20--Issue 6--p 507.
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    In addition, MedPAC's Report to Congress: Medicare Payment Policy 
\23\ over the past few years notes that the HIS Comprehensive 
Assessment Measure differentiates the hospice's overall ability to 
address care processes better than the seven individual HIS process 
measures. In this way, it provides consumers viewing data on Care 
Compare with a streamlined way to

[[Page 19731]]

assess the extent to which a hospice follows care processes.
---------------------------------------------------------------------------

    \23\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
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    We are not proposing any revisions to the HIS Comprehensive 
Assessment Measure in this proposed rule because the single measure 
continues to provide value to patients, their families, and providers.
    Because the HIS Comprehensive Assessment Measure is a more broadly 
applicable measure, we propose to remove the seven individual HIS 
process measures from the HQRP, no longer publicly reporting them as 
individual measures on Care Compare beginning with FY 2022. In 
addition, we are proposing to remove the ``7 measures that make up the 
HIS Comprehensive Assessment Measure'' section of Care Compare, which 
displays the seven HIS measures. We propose to make these changes 
removing the seven HIS process measures as individual measures from 
HQRP no earlier than May 2022.
    Although this proposal removes the seven individual HIS process 
measures, it does not propose any changes to the requirement to submit 
the HIS admission assessment. Since the HIS Comprehensive Assessment 
Measure is a composite of the seven HIS process measures, the burden 
and requirement to report the HIS data remain unchanged in the time, 
manner, and form finalized in the FY 2017 Hospice Wage Index and Rate 
Update final rule (81 FR 52144). Hospices which do not report HIS data 
used for the HIS Comprehensive Assessment Measure will not meet the 
requirements for compliance with the HQRP.
    We are soliciting public comment on the proposal to remove the 
seven HIS process quality measures as individual measures from the HQRP 
no earlier than May 2022, and to continue including the seven HIS 
process measures in the confidential quality measure (QM) Reports which 
are available to hospices. The seven HIS process measures are also 
available by visiting the data catalogue at https://data.cms.gov/provider-data/topics/hospice-care. We are also seeking public comment 
on the technical correction to the regulation at Sec.  418.312(b) 
effective October 1, 2021.
3. Proposal To Add a ``Claims-Based Index Measure'', the Hospice Care 
Index
    We are proposing a new hospice quality measure, called the Hospice 
Care Index (HCI), which will provide more information to better reflect 
several processes of care during a hospice stay, and better empower 
patients and family caregivers to make informed health care decisions. 
The HCI is a single measure comprising ten indicators calculated from 
Medicare claims data. The index design of the HCI simultaneously 
monitors all ten indicators. Collectively these indicators represent 
different aspects of hospice service and thereby characterize hospices 
comprehensively, rather than on just a single care dimension. 
Therefore, the HCI composite yields a more reliable provider ranking.
    The HCI indicators, through the composite, would add new 
information to HQRP that was either directly recommended for CMS to 
publicly report by Federal stakeholders 23 24 or identified 
as areas for improvement during information gathering activities. 
Furthermore, each indicator represents either a domain of hospice care 
recommended by leading hospice and quality experts \25\ for CMS to 
publicly report, or a requirement included in the hospice CoPs. The 
indicators required to calculate the single composite are discussed in 
the ``Specifications for the HCI Indicators Selected'' section below. 
These specifications list all the information required to calculate 
each indicator, including the numerator and denominator definitions, 
different thresholds for receiving credit toward the overall HCI score, 
and explanations for those thresholds. Indicators reflect practices or 
outcomes hospices should pursue, thereby awarding points based on the 
criterion. The HCI scoring example in Table 16 illustrates how points 
are awarded based on meeting the criterion of the indicator. For 
example, Gaps in Nursing Visits have a criterion of ``lower than the 
90th percentile,'' and supports the hospice CoPs that require a member 
of the interdisciplinary team to ensure ongoing assessment of patient 
and caregiver needs and plan of care implementation. Other indicators, 
such as nurse visits on weekends or near death, have a criterion of 
``higher than the 10th percentile,'' identifying hospice care delivery 
during the most vulnerable periods during a hospice stay.
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    \23\ 2019: Vulnerabilities in Hospice Care (Office of the 
Inspector General).
    \24\ Report to Congress: Medicare Payment Policy (March 2019) 
MEDPAC.
    \25\ 2019: Vulnerabilities in Hospice Care (Office of the 
Inspector General).
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    Each indicator equally affects the single HCI score, reflecting the 
equal importance of each aspect of care delivered from admission to 
discharge. A hospice is awarded a point for meeting each criterion for 
each of the 10 indicators. The sum of the points earned from meeting 
the criterion of each indictor results in the hospice's HCI score, with 
10 as the highest hospice score. The ten indicators, aggregated into a 
single HCI score, convey a broad overview of the quality of hospice 
care provision and validates well with CAHPS Willingness to Recommend 
and Rating of this Hospice.
    The HCI will help to identify whether hospices have aggregate 
performance trends that indicate higher or lower quality of care 
relative to other hospices. Together with other measures already 
publicly reported in the HQRP, HCI scores will help patients and family 
caregivers better decide between hospice providers based on the factors 
that matter most to them. Additionally, creating a comprehensive 
quality measure capturing a variety of related care processes and 
outcomes in a single metric will provide consumers and providers an 
efficient way to assess the overall quality of hospice care, which can 
be used to meaningfully and easily compare hospice providers to make a 
better-informed health care decision.
    The HCI will complement the existing HIS Comprehensive Measure and 
does not replace any existing reported measures. Both the HCI and the 
HIS Comprehensive Measure are composite measures in that they act as 
single measures that capture multiple areas of hospice care. Because 
the indicators comprising the HCI differ in data source from the HIS 
Comprehensive Measure, the HCI and the HIS Comprehensive Measure can 
together provide a meaningful and efficient way to inform patients and 
family caregivers, and support their selection of hospice care 
providers. As a claims-based measure, the HCI measure would not impose 
any new collection of information requirements. To learn more about the 
background of the HCI, please watch this video: https://youtu.be/by68E9E2cZc.
a. Measure Importance
    The FY 2019 Hospice Wage Index and Payment Rate Update final rule 
(83 FR 38622) introduced the Meaningful Measure Initiative to hospice 
providers to identify high priority areas for quality measurement and 
improvement. The Meaningful Measure Initiative areas are intended to 
increase measure alignment across programs and other public and private 
initiatives. Additionally, the initiative points to high priority areas 
where there may be informational gaps in available quality measures, 
while helping guide our efforts to develop and implement quality 
measures to fill those gaps, and develop those concepts towards quality 
measures that meet standards for public reporting. The goal of HQRP 
quality measure development is to identify measures from a variety of 
data sources that provide a window into

[[Page 19732]]

hospice care throughout the dying process, fit well with the hospice 
business model, and meet the objectives of the Meaningful Measures 
initiative.
    To that end, the HCI seeks to add value to the HQRP by filling 
informational gaps in aspects of hospice service not addressed by the 
current measure set. Consistent with the Meaningful Measure Initiative, 
we conducted a number of information gathering activities to identify 
informational gaps. Our information gathering activities included 
soliciting feedback from hospice stakeholders such as providers and 
family caregivers; seeking input from hospice and quality experts 
through a Technical Expert Panel (TEP); interviews with hospice quality 
experts; considering public comments received in response to previous 
solicitations on claims-based hospice quality initiatives; and a review 
of quality measurement recommendations offered by the OIG, MedPAC, and 
the peer-reviewed literature.
    We found that hospices currently underutilize HQRP measures to 
inform their quality improvement, mainly because of gaps in relevant 
quality information within the HQRP measure set. In particular, the 
existing HQRP measure set, calculated using data collected from the HIS 
and the CAHPS Hospice survey, does not assess quality of hospice care 
during a hospice election (between admission and discharge). Moreover, 
the current measure set does not directly address the full range of 
hospice services or outcomes. Therefore, we have identified a need for 
a new quality measure to address this gap and reflect care delivery 
processes during the hospice stay using available data without 
increasing data collection burden.
    Claims data are the best available data source for measuring care 
during the hospice stay and present an opportunity to bridge the 
quality measurement gap that currently exists between the HIS and CAHPS 
Hospice Survey. Medicare claims are administrative records of health 
care services provided and payments which Medicare (and beneficiaries 
as applicable) made for those services. Claims are a rich and 
comprehensive source about many care processes and aspects of health 
care utilization. As such, they are a valuable source of information 
that can be used to measure the quality of care provided to 
beneficiaries for several reasons:
     Claims data are readily-available and reduce provider 
burden for implementation, as opposed to data collection through 
patient assessments or surveys, which require additional effort from 
clinicians, patients, and family caregivers before they can be 
submitted and used by CMS.
     Claims data are collected based on care delivered, 
providing a more direct reflection of care delivery decisions and 
actions than patient assessments or surveys.
     Claims data are considered a reliable source of 
standardized data about the services provided, because providers must 
comply with Medicare payment and claims processing policy.
    Currently, CMS does publicly report several pieces of information 
derived from hospice claims data in the HQRP on Care Compare, including 
(i) the levels of care the hospice provided, (ii) the primary diagnoses 
the hospice served, (iii) the sites of service hospices provided care, 
and (iv) the hospice's daily census.
    In the FY2018 Hospice Wage Index & Payment Rate proposed rule (82 
FR 20750), we solicited public comment on two high-priority claims-
based measure concepts being considered at the time, one which looked 
at transitions from hospice and another which examined access to higher 
levels of hospice care. In response to this solicitation, CMS received 
public comments highlighting the potential limitations of a single 
concept claims-based measure. In particular, a single-concept claims-
based measure may not adequately account for all relevant circumstances 
that might influence a hospice's performance. While external 
circumstances could justify a hospice's poor performance on a single 
claims-based indicator, it would be unlikely for external circumstances 
to impact multiple claims-based indicators considered simultaneously. 
Therefore, the results of a multi-indicator claims-based index, such as 
HCI, is more likely to differentiate hospices than a single claims-
based indicator. Taking this public feedback into consideration, we 
designed the HCI and developed the specifications based on simulated 
reporting periods.
b. Specifications for the HCI Indicators Selected
    The specifications for the ten indicators required to calculate the 
single HCI score are described in this section. These component 
indicators reflect various elements and outcomes of care provided 
between admission and discharge. The HCI uses information from all ten 
indicators to collectively represent a hospice's ability to address 
patients' needs, best practices hospices should observe, and/or care 
outcomes that matter to consumers. Each indicator is a key component of 
the HCI measure that we are proposing, and all ten are necessary to 
derive the HCI score. We use analytics, based on a variety of data 
files, to specify the indicators and measure. These data files include:
     Medicare fee-for-service (FFS) hospice claims with through 
dates on and between October 1, 2016 and September 30, 2019 to 
determine information such as hospice days by level of care, provision 
of visits, live discharges, hospice payments, and dates of hospice 
election.
     Medicare fee-for-service inpatient claims with through 
dates on and between January 1, 2016 and December 31, 2019 to determine 
dates of hospitalization.
     Medicare beneficiary summary file to determine dates of 
death.
     Provider of Services (POS) File to examine trends in the 
scores of the HCI and its indicators, including by decade by which the 
hospice was certified for Medicare, ownership status, facility type, 
census regions, and urban/rural status.
     CAHPS Hospice Survey to examine alignment between the 
survey outcomes and the HCI.
    We acquired all claims data from the Chronic Conditions Warehouse 
(CCW) Virtual Research Data Center (VRDC). We obtained the hospice 
claims and the Medicare beneficiary summary file in May 2020, and the 
inpatient data in August 2020. We obtained the POS file data via: 
https://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Provider-of-Services. We obtained the Hospice-
aggregate CAHPS Hospice Survey outcome data via: https://data.cms.gov/provider-data. We performed analyses using Stata/MP Version 16.1.
    Table 17 indicates the number of hospice days, hospice claims, 
beneficiaries enrolled in hospices and hospices with at least one claim 
represented in each year of our analysis. Analysis for each year was 
based on the FY calendar. For example, FY 2019 covers claims with dates 
of services on or between October 1, 2018 and September 30, 2019. For 
these analyses, we exclude claims from hospices with 19 or fewer 
discharges \26\ within a FY. The table reports the sample size before 
and after exclusion.\27\
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    \26\ We count discharges as any claim with a discharge status 
code other than ``30'' (which is defined as ``Still Patient'')
    \27\ Another exclusion was made prior to reporting the numbers 
in Table B.1. We exclude all claims for a beneficiary if a 
beneficiary ever had two overlapping hospice days on separate 
claims. For FY 2019 this removes 5,212,319 hospice days that come 
from 218,420 claims and 33,009 beneficiaries.

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[[Page 19733]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.023

    The rest of this section presents the component indicators and 
their specifications. Although we describe each component indicator 
separately, the HCI is a composite that can only be calculated using 
all 10 indicators combined. We believe that, composed of this set of 
ten indicators, the HCI will strengthen the HQRP by comprehensively, 
reflecting hospices' performance across all ten indicators.
(1). Indicator One: Continuous Home Care (CHC) or General Inpatient 
(GIP) Provided
    Medicare Hospice Conditions of Participation (CoPs) require 
hospices to be able to provide both CHC and GIP levels of care, if 
needed to manage more intense symptoms.28 29 However, a 2013 
OIG report \30\ found that 953 hospice programs did not provide any GIP 
level of care services, and it was unclear if dying patients at such 
hospices were receiving appropriate pain control or symptoms management 
(a similar concern exists for hospice services at the CHC level). To 
consider the provision of adequate services needed to manage patients' 
symptoms, the HCI measure includes an indicator for whether hospice 
programs provided any CHC or GIP service days. This indicator 
identifies hospices that provided at least one day of hospice care 
under the CHC or the GIP levels of care during the period examined. The 
provision of CHC and GIP is identified on hospice claims by the 
presence of revenue center codes 0652 (CHC) and 0656 (GIP).
---------------------------------------------------------------------------

    \28\ See Special coverage requirements, Title 42, Chapter IV, 
Subchapter B, Part 418, Sec.  418.204. https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_1204.
    \29\ See Payment procedures for hospice care, Title 42, Chapter 
IV, Subchapter B, Part 418, Sec.  418.302. https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_1302.
    \30\ Office of Inspector General. (2013). Medicare Hospice: Use 
of General lnpatient Care. https://oig.hhs.gov/oei/reports/oei-02-10-00490.pdf.
---------------------------------------------------------------------------

    The specifications for Indicator One, CHC or GIP services provided, 
are as follows:
     Numerator: The total number of CHC or GIP services days 
provided by the hospice within a reporting period.
     Denominator: The total number of hospice service days 
provided by the hospice at any level of care within a reporting period.
     Index Earned Point Criterion: Hospices earn a point 
towards the HCI if they provided at least one CHC or GIP service day 
within a reporting period.
(2). Indicator Two: Gaps in Nursing Visits
    The Medicare Hospice CoPs require a member of the interdisciplinary 
team to ensure ongoing assessment of patient and caregiver needs and 
plan of care implementation.\31\ The OIG has found instances of 
infrequent visits by nurses to hospice patients.\32\ To assess 
patients' receipt of adequate oversight, one HCI indicator examines 
hospices that have a high rate of patients who are not seen at least 
once a week by nursing staff.
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    \31\ See Sec.  418.56 (https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_156) and Sec.  418.76 
(https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_176).
    \32\ Office of Inspector General. (2019). Hospice Deficiencies 
Pose Risks to Medicare Beneficiaries. https://oig.hhs.gov/oei/reports/oei-02-17-00020.pdf?utm_source=summary-page&utm_medium=web&utm_campaign=OEI-02-17-00020-PDF.
---------------------------------------------------------------------------

    This indicator identifies whether a hospice is below the 90th 
percentile in terms of how often hospice stays of at least 30 days 
contain at least one gap of eight or more days without a nursing visit. 
Days of hospice service are identified based on the presence of revenue 
center codes 0651 (routine home care (RHC)), 0652 (CHC), 0655 
(inpatient respite care (IRC)), and 0656 (GIP) on hospice claims. We 
identify the dates billed for RHC, IRC, and GIP by examining the 
corresponding revenue center date (which identifies the first day in 
the sequence of days by level of care) and the revenue center units 
(which identify the number of days (including the first day) in the 
sequence of days by level of care). We identify the dates billed for 
CHC by examining the revenue center date.\33\ We define a hospice stay 
by a sequence of consecutive days for a particular beneficiary that are 
billed under the hospice benefit. A gap of at least 1 day without 
hospice ends the sequence. For this indicator, we identified hospice 
stays that included 30 or more consecutive days of hospice. Once we 
identified those hospice stays, we examined the timing of the provision 
of nursing visits within those stays. We identified nursing visits if 
we observed any of the following criteria:
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    \33\ Hospices bill each day of CHC on a separate line item on 
the hospice claim.
---------------------------------------------------------------------------

     The presence of revenue center code 055x (Skilled Nursing) 
on the hospice claim. The date of the visit is recorded in the 
corresponding revenue center date.
     The presence of revenue code 0652 (CHC) on the hospice 
claim. Days billed as CHC require more than half the hours provided be 
nursing hours.
     The presence of revenue code 0656 (GIP) on the hospice 
claim. We assume that days billed as GIP will include nursing visits. 
We make that assumption instead of looking at the visits directly 
because Medicare does not require hospices to record all visits on the 
claim for the GIP level of care.
    Based on the above information, if within a hospice stay, we find 
eight or more consecutive days where no nursing visits are provided, no 
CHC is provided, and no GIP is provided, then we identify the hospice 
stay as having a gap in nursing visits greater than 7 days. This 
indicator helps the HCI to capture patients' receipt of adequate 
oversight through nurse visits and direct patient care, which is an 
important aspect of hospice care. For each hospice, we divide the 
number of stays with at least one gap of eight or more days without a 
nursing visit (for stays of 30 or more days) by the number of stays of 
30 or more days. We only consider the days within the period being 
examined.
    The specifications for Indicator Two, Gaps in Nursing Visits, are 
as follows:

[[Page 19734]]

     Numerator: The number of elections with the hospice where 
the patient experienced at least one gap between nursing visits 
exceeding 7 days, excluding hospice elections where the patient elected 
hospice for less than 30 days within a reporting period.
     Denominator: The total number of elections with the 
hospice, excluding hospice elections where the patient elected hospice 
for less than 30 days within a reporting period.
     Index Earned Point Criterion: Hospices earn a point 
towards the HCI if their individual hospice score for gaps in nursing 
visits greater than 7 days falls below the 90th percentile ranking 
among hospices nationally.
(3). Indicator Three: Early Live Discharges
    Prior work has identified various concerning patterns of live 
discharge from hospice. High rates of live discharge suggest concerns 
in hospices' care processes, their advance care planning to prevent 
hospitalizations, or their discharge processes.\34\ As MedPAC 
noted,\35\ ``Hospice providers are expected to have some rate of live 
discharges because some patients change their mind about using the 
hospice benefit and dis-enroll from hospice or their condition improves 
and they no longer meet the hospice eligibility criteria. However, 
providers with substantially higher percent of live discharge than 
their peers could signal a potential concern with quality of care or 
program integrity. An unusually high rate of live discharges could 
indicate that a hospice provider is not meeting the needs of patients 
and families or is admitting patients who do not meet the eligibility 
criteria.''
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    \34\ Teno J.M., Bowman, J., Plotzke, M., Gozalo, P.L., 
Christian, T., Miller, S.C., Williams, C., & Mor, V. (2015). 
Characteristics of hospice programs with problematic live 
discharges. Journal of Pain and Symptom Management, 50, 548-552. 
doi: 10.1016/j.jpainsymman.2015.05.001.
    \35\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
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    Our live discharge indicators included in the HCI, like MedPAC's, 
comprise discharges for all reasons. They include instances where the 
patient was no longer found terminally ill and revocations due to the 
patient's choice. MedPAC explains their rationale for including all 
discharge as follows:\36\
---------------------------------------------------------------------------

    \36\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
---------------------------------------------------------------------------

    ``Some stakeholders argue that live discharges initiated by the 
beneficiary--such as when the beneficiary revokes his or her hospice 
enrollment--should not be included in a live-discharge measure because, 
some stakeholders assert, these discharges reflect beneficiary 
preferences and are not in the hospice's control. Because beneficiaries 
may choose to revoke hospice for a variety of reasons, which in some 
cases are related to the hospice provider's business practices or 
quality of care, we include revocations in our analysis.''
    This indicator identifies whether a hospice is below the 90th 
percentile in terms of the percentage of live discharges that occur 
within 7 days of hospice admission during the fiscal year examined. 
Live discharges occur when the patient discharge status code on a 
hospice claim does not equal a code from the following list: ``30'', 
``40'', ``41'', ``42'', ``50'', ``51''. We measure whether a live 
discharge occurs during the first 7 days of hospice by looking at a 
patient's lifetime length of stay in hospice.\37\ For each hospice, we 
divide the number of live discharges in the first 7 days of hospice by 
the number of live discharges. Live discharges are assigned to a 
particular reporting period based on the date of the live discharge 
(which corresponds to the through date on the claim indicating the live 
discharge).
---------------------------------------------------------------------------

    \37\ That is, we are measuring the first seven days of hospice 
over a patient's lifetime and potentially across multiple hospice 
elections and fiscal years.
---------------------------------------------------------------------------

    The specifications for Indicator Three, Early Live Discharges, are 
as follows:
     Numerator: The total number of live discharges from the 
hospice occurring within the first 7 days of hospice within a reporting 
period.
     Denominator: The total number of all live discharge from 
the hospice within a reporting period.
     Index Earned Point Criterion: Hospices earn a point 
towards the HCI if their individual percentage of live discharges on or 
before the seventh day of hospice falls below the 90th percentile 
ranking among hospices nationally.
(4). Indicator Four: Late Live Discharges
    The rate of live discharge that occurred 180 days or more after 
hospice enrollment identifies another potentially concerning pattern of 
live discharge from hospice. Both indicator three and indicator four of 
the HCI recognize concerning patterns of live discharge impacting 
patient experience and quality of care. MedPAC, in descriptive analyses 
of hospices exceeding the Medicare annual payment cap, noted that ``if 
some hospices have rates of discharging patients alive that are 
substantially higher than most other hospices it raises concerns that 
some hospices may be pursuing business models that seek out patients 
likely to have long stays who may not meet the hospice eligibility 
criteria''.\38\ Because of quality implications for hospices who pursue 
such business models, the live discharge after long hospice enrollments 
was included in the index.
---------------------------------------------------------------------------

    \38\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
---------------------------------------------------------------------------

    This indicator identifies whether a hospice is below the 90th 
percentile in terms of the percentage of live discharges that occur on 
or after the 180th day of hospice. Live discharges occur when the 
patient discharge status code does not equal a value from the following 
list: ``30'', ``40'', ``41'', ``42'', ``50'', ``51''. We measure 
whether a live discharge occurs on or after the 180th day of hospice by 
looking at a patient's lifetime length of stay in hospice. For each 
hospice, we divide the number of live discharges that occur on or after 
the 180th day of hospice by the number of live discharges. Live 
discharges are assigned to a particular reporting period based on the 
date of the live discharge (which corresponds to the through date on 
the claim).
    The specifications for Indicator Four, Late Live Discharges, are as 
follows:
     Numerator: The total number of live discharges from the 
hospice occurring on or after 180 days of enrollment in hospice within 
a reporting period.
     Denominator: The total number of all live discharge from 
the hospice within a reporting period.
     Index Earned Point Criterion: Hospices earn a point 
towards the HCI if their individual hospice score for live discharges 
on or after the 180th day of hospice falls below the 90th percentile 
ranking among hospices nationally.
(5). Indicator Five: Burdensome Transitions (Type 1)--Live Discharges 
From Hospice Followed by Hospitalization and Subsequent Hospice 
Readmission
    The Type 1 burdensome transitions reflects hospice live discharge 
with a hospital admission within 2 days of hospice discharge, and then 
hospice readmission within 2 days of hospital discharge. This pattern 
of transitions may lead to fragmented care and may be associated with 
concerning care processes. For example, Type 1 burdensome transitions 
may arise from a deficiency in advance care planning to prevent 
hospitalizations or a discharge process that does not appropriately 
identify a hospice patient whose conditions are stabilized prior to 
discharge.\39\
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    \39\ For example, see: Teno J.M., Bowman, J., Plotzke, M., 
Gozalo, P.L., Christian, T., Miller, S.C., Williams, C., & Mor, V. 
(2015). Characteristics of hospice programs with problematic live 
discharges. Journal of Pain and Symptom Management, 50, 548-552. 
doi: 10.1016/j.jpainsymman.2015.05.001.

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[[Page 19735]]

    This indicator identifies whether a hospice is below the 90th 
percentile in terms of the percentage of live discharges that are 
followed by a hospitalization (within 2 days of hospice discharge) and 
then followed by a hospice readmission (within 2 days of 
hospitalization) during the FY examined. Live discharges occur when the 
patient discharge status code does not equal a value from the following 
list: ``30'', ``40'', ``41'', ``42'', ``50'', ``51''. Hospitalizations 
are found by looking at all fee-for-service Medicare inpatient claims. 
Overlapping inpatient claims were combined to determine the full length 
of a hospitalization (looking at the earliest from date and latest 
through date from a series of overlapping inpatient claims for a 
beneficiary). In order to be counted, the ``from'' date of the 
hospitalization had to occur no more than 2 days after the date of 
hospice live discharge.\40\ From there, we found all beneficiaries that 
ended their hospitalization and were readmitted back to hospice no more 
than 2 days after the last date of the hospitalization. To calculate 
the percentage, for each hospice we divided the number of live 
discharges that are followed by a hospitalization (within 2 days of 
hospice discharge) and then followed by a hospice readmission (within 2 
days of hospitalization) in a given reporting period by the number of 
live discharges in that same period.
---------------------------------------------------------------------------

    \40\ For example, if the hospice discharge occurred on a Sunday, 
the hospitalization had to occur on Sunday, Monday, or Tuesday to be 
counted.
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    The specifications for Indicator Five, Burdensome Transitions Type 
1, are as follows:
     Numerator: The total number of live discharges from the 
hospice followed by hospital admission within 2 days, then hospice 
readmission within 2 days of hospital discharge within a reporting 
period.
     Denominator: The total number of all live discharge from 
the hospice within a reporting period.
     Index Earned Point Criterion: Hospices earn a point 
towards the HCI if their individual hospice score for Type 1 burdensome 
transitions falls below the 90th percentile ranking among hospices 
nationally.
(6). Indicator Six: Burdensome Transitions (Type 2)--Live Discharges 
From Hospice Followed by Hospitalization With the Patient Dying in the 
Hospital
    Death in a hospital following live discharge in another concerning 
pattern in hospice use. Thus, we believe that indicators five and 
indicator six of the HCI are necessary to differentiate concerning 
behaviors affecting patient care. This indicator reflects hospice live 
discharge followed by hospitalization within 2 days with the patient 
dying in the hospital, referred to as Type 2 burdensome transitions. 
This pattern of transitions may be associated with a discharge process 
that does not appropriately assess the stability of a hospice patient's 
conditions prior to live discharge.\41\
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    \41\ For example, see: Teno J.M., Bowman, J., Plotzke, M., 
Gozalo, P.L., Christian, T., Miller, S.C., Williams, C., & Mor, V. 
(2015). Characteristics of hospice programs with problematic live 
discharges. Journal of Pain and Symptom Management, 50, 548-552. 
doi: 10.1016/j.jpainsymman.2015.05.001.
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    This indicator identifies whether a hospice is below the 90th 
percentile in terms of the percentage of live discharges that are 
followed by a hospitalization (within two days of hospice discharge) 
and then the patient dies in the hospital. Live discharges occur when 
the patient discharge status code does not equal a value from the 
following list: ``30'', ``40'', ``41'', ``42'', ``50'', ``51''. 
Hospitalizations are found by looking at all inpatient claims. 
Overlapping inpatient claims were combined to determine a full length 
of a hospitalization (looking at the earliest from date and latest 
through date from a series of overlapping inpatient claims). To be 
counted, the ``from'' date of the hospitalization had to occur no more 
than 2 days after the date of hospice live discharge. From there, we 
identified all beneficiaries whose date of death is listed as occurring 
during the dates of the hospitalization. To calculate the percentage, 
for each hospice we divided the number of live discharges that are 
followed by a hospitalization (within 2 days of hospice discharge) and 
then the patient dies in the hospital in a given FY by the number of 
live discharges in that same reporting period.
    The specifications for Indicator Six, Burdensome Transitions Type 
2, are as follows:
     Numerator: The total number of live discharges from the 
hospice followed by a hospitalization within 2 days of live discharge 
with death in the hospital within a reporting year.
     Denominator: The total number of all live discharge from 
the hospice within a reporting year.
     Index Earned Point Criterion: Hospices earn a point 
towards the HCI if their individual hospice score for Type 2 burdensome 
transitions falls below the 90th percentile ranking among hospices 
nationally.
(7). Indicator Seven: Per-Beneficiary Medicare Spending
    Estimates of per-beneficiary spending are endorsed by NQF (#2158) 
\42\ and publicly reported by CMS for other care settings. Because the 
Medicare hospice benefit pays a per diem rate, an important determinant 
of per-beneficiary spending is the length of election. MedPAC reported 
that nearly half of Medicare hospice expenditures are for patients that 
have had at least 180 or more days on hospice, and expressed a concern 
that some programs do not appropriately discharge patients whose 
medical condition makes them no longer eligible for hospice services, 
or, that that hospices selectively enroll patients with non-cancer 
diagnoses and longer predicted lengths of stay in hospice.\43\ The 
other determinant of per-beneficiary spending is the level of care at 
which services are billed. In a 2016 report, the OIG has expressed 
concern at the potentially inappropriate billing of GIP care.\44\ For 
these reasons the HCI includes one indicator for per-beneficiary 
spending; lower rates of per beneficiary spending may identify hospices 
that provide efficient care at a lower cost to Medicare.
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    \42\ National Quality Forum. (2013). #2158 Payment-Standardized 
Medicare Spending Per Beneficiary (MSPB). https://www.qualityforum.org/Projects/c-d/Cost_and_Resource_Project/2158.aspx.
    \43\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
    \44\ Office of Inspector General. (2016). Hospices 
Inappropriately Billed Medicare Over $250 Million for General 
Inpatient Care. https://oig.hhs.gov/oei/reports/oei-02-10-00491.pdf.
---------------------------------------------------------------------------

    This indicator identifies whether a hospice is below the 90th 
percentile in terms of the average Medicare hospice payments per 
beneficiary. Hospice payments per beneficiary are determined by summing 
together all payments on hospice claims for a particular reporting year 
for a particular hospice. The number of beneficiaries a hospice serves 
in a particular year is determined by counting the number of unique 
beneficiaries on all hospice claims in the same period for a particular 
hospice. Medicare spending per beneficiary is then calculated by 
dividing the total payments by the total number of unique 
beneficiaries.
    The specifications for Indicator Seven, Per-Beneficiary Medicare 
Spending, are as follows:

[[Page 19736]]

     Numerator: Total Medicare hospice payments received by a 
hospice within a reporting period.
     Denominator: Total number of beneficiaries electing 
hospice with the hospice within a reporting period.
     Index Earned Point Criterion: Hospices earn a point 
towards the HCI if their average Medicare spending per beneficiary 
falls below the 90th percentile ranking among hospices nationally.
(8). Indicator Eight: Nurse Care Minutes per Routine Home Care (RHC) 
Day
    Medicare Hospice CoPs require a member of the interdisciplinary 
team to ensure ongoing assessment of patient and caregiver needs.\45\ 
Such assessment is necessary to ensure the successful preparation, 
implementation, and refinements for the plan of care. Hospices must 
also ensure that patients and caregivers receive education and training 
as appropriate to their responsibilities for the care and services 
identified in the plan of care. To assess adequate oversight, the HCI 
includes this indicator assessing the average number of skilled nursing 
minutes per day during RHC days to differentiate hospices that are 
providing assessment throughout the hospice stay.
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    \45\ See Condition of participation: Interdisciplinary group, 
care planning, and coordination of services, Title 42, Chapter IV, 
Subchapter B, Part 418, Sec.  418.56 (https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_156) and Condition 
of participation: Hospice aide and homemaker services, Title 42, 
Chapter IV, Subchapter B, Part 418, Sec.  418.76 (https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_176).
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    This indicator identifies whether a hospice is above the 10th 
percentile in terms of the average number of nursing minutes provided 
on RHC days during the reporting period examined. We identify RHC days 
by the presence of revenue code 0651 on the hospice claim. We identify 
the dates of RHC service by the corresponding revenue center date 
(which identifies the first day of RHC) and the revenue center units 
(which identifies the number of days of RHC (including the first day of 
RHC)). We identify nursing visits by the presence of revenue code 055x 
(Skilled Nursing) on the claim. We count skilled nursing visits where 
the corresponding revenue center date overlaps with one of the days of 
RHC previously identified. We then count the minutes of skilled nursing 
visits by taking the corresponding revenue center units (that is, one 
unit is 15 minutes) and multiplying by 15. For each hospice, we sum 
together all skilled nursing minutes provided on RHC days and divide by 
the sum of RHC days.
    The specifications for Indicator Eight, Nurse Care Minutes per RHC 
Day, are as follows:
     Numerator: Total skilled nursing minutes provided by a 
hospice on all RHC service days within a reporting period.
     Denominator: The total number of RHC days provided by a 
hospice within a reporting period.
     Index Earned Point Criterion: Hospices earn a point 
towards the HCI if their individual hospice score for Nursing Minutes 
per RHC day falls above the 10th percentile ranking among hospices 
nationally.
(9). Indicator Nine: Skilled Nursing Minutes on Weekends
    Our regulations at Sec.  418.100(c)(2) require that ``[n]ursing 
services, physician services, and drugs and biologicals . . . be made 
routinely available on a 24-hour basis seven days a week''.\46\ Ongoing 
assessment of patient and caregiver needs and plan of care 
implementation are necessary for adequate hospice care oversight. Fewer 
observed hospice services on weekends (relative to that provided on 
weekdays) is not itself an indication of a lack of access. In fact, on 
weekends, patients' caregivers are more likely to be around and could 
prefer privacy from hospice staff. However, patterns of variation 
across providers could signal less service provider availability and 
access for patients on weekends. Thus, the HCI includes this indicator 
to further differentiate whether care is available to patients on 
weekends. To assess hospice service availability, this indicator 
includes minutes of care provided by skilled nurses on weekend RHC 
days.
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    \46\ See Sec.  418.100 (https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_1100).
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    This indicator identifies whether a hospice is at or above the 10th 
percentile in terms of the percentage of skilled nursing minutes 
performed on weekends compared to all days during the reporting period 
examined. We identify RHC days by the presence of revenue code 0651 on 
the hospice claim. We identify the dates of RHC service by the 
corresponding revenue center date (which identifies the first day of 
RHC) and the revenue center units (which identifies the number of days 
of RHC (including the first day of RHC)). We identify nursing visits by 
the presence of revenue code 055x (Skilled Nursing) on the claim. We 
count skilled nursing visits where the corresponding revenue center 
date overlaps with one of the days of RHC previously identified. We 
then count the minutes of skilled nursing visits by taking the 
corresponding revenue center units and multiplying by 15. For each 
hospice, we sum together all skilled nursing minutes provided on RHC 
days that occur on a Saturday or Sunday and divide by the sum of all 
skilled nursing minutes provided on all RHC days.
    The specifications for Indicator Nine, Skilled Nursing Minutes on 
Weekends, are as follows:
     Numerator: Total sum of minutes provided by the hospice 
during skilled nursing visits during RHC services days occurring on 
Saturdays or Sunday within a reporting period.
     Denominator: Total skilled nursing minutes provided by the 
hospice during RHC service days within a reporting period.
     Index Earned Point Criterion: Hospices earn a point 
towards the HCI if their individual hospice score for percentage of 
skilled nursing minutes provided during the weekend is above the 10th 
percentile ranking among hospices nationally.
(10). Indicator Ten: Visits Near Death
    The end of life is typically the period in the terminal illness 
trajectory with the highest symptom burden. Particularly during the 
last few days before death, patients (and caregivers) experience many 
physical and emotional symptoms, necessitating close care and attention 
from the integrated hospice team and drawing increasingly on hospice 
team resources.47 48 49 Physical symptoms of actively dying 
can often be identified within three days of death in some 
patients.\50\
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    \47\ de la Cruz, M., et al. (2015). Delirium, agitation, and 
symptom distress within the final seven days of life among cancer 
patients receiving hospice care. Palliative & Supportive Care, 
13(2): 211-216. doi: 10.1017/S1478951513001144.
    \48\ Dellon, E.P., et al. (2010). Family caregiver perspectives 
on symptoms and treatments for patients dying from complications of 
cystic fibrosis. Journal of Pain & Symptom Management, 40(6): 829-
837. doi: 10.1016/j.jpainsymman.2010.03.024.
    \49\ Kehl, K.A., et al. (2013). A systematic review of the 
prevalence of signs of impending death and symptoms in the last 2 
weeks of life. American Journal of Hospice & Palliative Care, 30(6): 
601-616. doi: 10.1177/1049909112468222.
    \50\ Hui D et al. (2014). Clinical Signs of Impending Death in 
Cancer Patients. The Oncologist. 19(6):681-687. doi:10.1634/
theoncologist.2013-0457.
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    This indicator identifies whether a hospice is at or above the 10th 
percentile in terms of the percentage of beneficiaries with a nurse 
and/or medical social services visit in the last 3 days of life. For 
this indicator, we first

[[Page 19737]]

determine if a beneficiary was in hospice for at least 1 day during 
their last 3 days of life by comparing days of hospice enrollment from 
hospice claims to their date of death. We identify nursing visits and 
medical social service visits by the presence of revenue code 055x 
(Skilled Nursing) and 056x (Medical Social Services) on the claim. We 
identify the dates of those visits by the revenue center date for those 
revenue codes.
    Additionally, we assume that days billed as GIP (revenue code 0656) 
will include nursing visits. We make that assumption instead of looking 
at the visits directly because Medicare does not require hospices to 
record all visits on the claim for the GIP level of care. For each 
hospice, we divide the number of beneficiaries with a nursing or 
medical social service visits on a hospice claim during the last 3 days 
of life by the number of beneficiaries with at least 1 day of hospice 
during the last 3 days of life.
    The specifications for Indicator Ten, Visits Near Death, are as 
follows:
     Numerator: The number of decedent beneficiaries receiving 
a visit by a skilled nurse or social worker staff for the hospice in 
the last 3 days of the beneficiary's life within a reporting period.
     Denominator: The number of decedent beneficiaries served 
by the hospice within a reporting period.
     Index Earned Point Criterion: Hospices earn a point 
towards the HCI if their individual hospice score for percentage of 
decedents receiving a visit by a skilled nurse or social worked in the 
last 3 days of life falls above the 10th percentile ranking among 
hospices nationally.
(11). Hospice Care Index Scoring Example
    As discussed during the NQF's January 2021 MAP meeting, the HCI 
summarizes information from ten indicators with each indicator 
representing key components of the hospice care recognizing care 
delivery and processes. Hospices receive a single HCI score, which 
reflects the information from all ten indicators. Specifically, a 
hospice's HCI score is based on its collective performance on the ten 
performance indicators detailed above, all of which must be included to 
calculate the score and meaningfully distinguish between hospices' 
relative performance. The HCI's component indicators are assigned a 
criterion determined by statistical analysis of an individual hospice's 
indicator score relative to national hospice performance. Table 18 
illustrates how a hypothetical hospice's score is determined across all 
ten indicators, and how the ten indicators' scores determine the 
overall HCI score.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TP14AP21.024


[[Page 19739]]


BILLING CODE 4120-01-C
c. Measure Reportability, Variability, and Validity
    As part of developing the HCI, we conducted reportability, 
variability, and validity testing using claims data from FY 2019. 
Reportability analyses found a high proportion of hospices (over 85 
percent) that would yield reportable measure scores over 1 year (for 
more on reportability analysis, see section (2) Update on Use of Q4 
2019 Data and Data Freeze for Refreshes in 2021.). Variability analyses 
confirmed that HCI demonstrates sufficient ability to differentiate 
hospices. Hospices' scores on the HCI can range from zero to ten. 
During measure testing, we observed that hospices achieved scores 
between three and ten. In testing, 37.1 percent of hospices scored ten 
out of ten, 30.4 percent scored nine out of ten, 17.9 percent scored 
eight out of ten, 9.6 percent scored seven out of ten, and 5.0 percent 
scored six or lower, as shown in Figure 6.
[GRAPHIC] [TIFF OMITTED] TP14AP21.025

    Validity analyses showed that hospices' HCI scores align with 
family caregivers' perceptions of hospice quality, as measured by CAHPS 
Hospice survey responses (NQF endorsed quality measure #2651). Hospices 
with higher HCI scores generally achieve better caregiver ratings as 
measured by CAHPS Hospice scores, and hospices with lower HCI scores 
generally achieve poorer CAHPS Hospice scores. As measured by Pearson's 
correlation coefficients, the correlation between the CAHPS hospice 
overall rating and the HCI is +0.0675, and the correlation between the 
CAHPS hospice recommendation outcome and the HCI score is +0.0916. As 
such, HCI scores are consistent with CAHPS Hospice caregiver ratings, 
supporting the index as a valid measurement of hospice care.
    We also conducted a stability analysis by comparing index scores 
calculated for the same hospice using claims from Federal FY 2017 and 
2019. The analysis found that 82.8 percent of providers' scores changed 
by, at most, one point over the 2 years. These results serve as 
evidence of the measure's reliability by indicating that a hospice's 
HCI scores would not normally fluctuate a great deal from one year to 
the next.
d. Stakeholder Support
    A TEP convened by our measure development contractor, in April 
2020, provided input on this measure concept. Additionally, during the 
summer of 2020, CMS convened five listening sessions with national 
hospice provider organizations to discuss the HCI concept with the 
goals of engaging stakeholders and receiving feedback early in the 
measure's development. In October 2020, our contractor, Abt Associates, 
convened a workgroup of family caregivers whose family members have 
received hospice care to provide input on this measure concept from the 
family and caregiver perspective. Finally, the NQF Measures Application 
Partnership (MAP) met on January 11, 2021 and provided input to CMS. 
The MAP conditionally supports the HCI for rulemaking contingent on NQF 
endorsement. The ``2020-2021 MAP 2020 Final Recommendations'' can be 
found at: http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94893.
    Stakeholders were generally supportive of a quality measure based 
on multiple indicators using claims data for public reporting. Several 
hospice providers expressed support for the measure's ability to 
demonstrate greater variation in hospice performance than the component 
indicators taken individually. Hospice caregivers also welcomed the 
addition of new quality measures to HQRP to better differentiate 
between hospices. In particular, family caregivers stated that there 
might be a need for several HCI indicators, such as nursing 
availability on weekends and average Medicare per-beneficiary spending, 
to be included on Care Compare as additional information.
    Some stakeholders raised concerns that claims data may not 
adequately express the quality of care provided, and may be better 
suited as an indicator for program integrity or compliance issues. 
Hospice providers suggested that claims may lack sufficient information 
to adequately reflect individual patient needs or the full array of 
hospice

[[Page 19740]]

practices. In particular, claims do not fully capture patients' 
clinical conditions, patient and caregiver preferences, or hospice 
activities such as telehealth, chaplain visits, and specialized 
services such as massage or music therapy. After much consideration of 
the input received, we believe the benefits of proposing adoption of 
the HCI outweigh its limitations. The HCI would not be intended to 
account for all potentially valuable aspects of hospice care, nor would 
it be expected to entirely close the information gaps presently found 
in the HQRP. Rather, the HCI would serve as a useful measure to add 
value to the HQRP by providing more information to patients and family 
caregivers and better empowering them to make informed health care 
decisions. We view the HCI as an opportunity to add value to the HQRP, 
augmenting the current measure set with an index of indicators compiled 
from currently available claims data. This will provide new and useful 
information to patients and family caregivers without further burden to 
them, or to providers.
    Stakeholders also suggested several valuable exploratory analyses, 
improvements for the indicators presented, and ideas for eventual 
public display for CMS to consider. We further refined the HCI based on 
this feedback, focusing on those indicators with the strongest 
consistency with CAHPS Hospice scores and/or which quality experts have 
identified as salient issues for measurement and observation. We also 
revised and refined how the HCI will be publicly displayed on Care 
Compare in response to family caregiver input.
e. Form, Manner and Timing of Data Collection and Submission
    The data source for this HCI measure will be Medicare claims data 
that are already collected and submitted to CMS. We propose to begin 
reporting this measure using existing data items no earlier than May 
2022. For more details, see section (3). Proposal to Publicly Report 
the Hospice Care Index and Hospice Visits in the Last Days of Life 
Claims-based Measures.
    In addition, to help hospices understand the HCI and their 
hospice's performance, we will revise the confidential QM report to 
include claims-based measure scores, including agency and national 
rates through the Certification and Survey Provider Enhanced Reports 
(CASPER) or replacement system. The QM report will also include results 
of the individual indicators used to calculate the single HCI score, 
and provide details on the indicators and HCI overall score to support 
hospices in interpreting the information. The HCI indicators will be 
available by visiting the Provider Data Catalog at https://data.cms.gov/provider-data/topics/hospice-care.
    We are soliciting public comment on the proposal to add the 
composite HCI measure to the HQRP starting in FY 2022. We are also 
soliciting comments on the proposal to add the HCI to the program for 
public reporting beginning no earlier than May 2022.
4. Update on the Hospice Visits in the Last Days of Life (HVLDL) and 
Hospice Item Set V3.00
    On August 13, 2020, we sought public comment in an information 
collection request to remove Section O ``Service Utilization'' 
(hereafter referred to as Section O) of the HIS discharge assessment. 
Removal of Section O is the sole change from HIS V2.01 and in effect 
eliminate the HVWDII quality measure pair. In Paperwork Reduction Act 
package (PRA), CMS-10390 (OMB control number: 0938-1153), we also 
proposed to replace the HVWDII measure pair with the HVLDL. This means 
that we will no longer report HVWDII with patient discharges and will 
start publicly reporting HVLDL no earlier than May 2022. The Office of 
Management and Budget (OMB) approved the collection of information to 
remove Section O of the HIS expiring on February 29, 2024, (OMB Control 
Number: 0938-1153, CMS-10390). We direct the public to review the PRA 
at https://www.cms.gov/regulations-and-guidancelegislationpaperworkreductionactof1995pra-listing/cms-10390 and 
HVWDII report at https://www.cms.gov/files/document/hqrphospice-visits-when-death-imminent-testing-re-specification-reportoctober-2020.pdf. As 
a claims-based measure, the HVLDL measure would not impose any new 
collection of information requirements.
    The HVLDL measure, as a replacement, will continue to fill an 
important area in hospice care previously filled by the HVWDII measure 
pair. We discussed the analysis with a TEP convened by our measure 
development contractor in November 2019 and with the MAP, hosted by the 
NQF in December 2019 \51\ for inclusion in the HQRP. During these 
meetings, the discussions reflecting on the analysis generally 
supported the replacement of HVWDII with a claims-based HVLDL measure. 
The November 2019 TEP report can be found in the downloads section at 
Hospice QRP Provider Engagement Opportunities and final recommendations 
and presentation of the HVLDL measure before NQF's MAP can be found at 
Quality Forum--Post-Acute Care, https://www.qualityforum.org/Publications/2020/02/MAP_2020_Considerations_for_Implementing_Measures_Final_Report_-_PAC_LTC.aspx.
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    \51\ National Quality Forum. (2020). MAP 2020 Considerations for 
Implementing Measures Final Report--PAC LTC. http://www.qualityforum.org/Publications/2020/02/MAP_2020_Considerations_for_Implementing_Measures_Final_Report_-_PAC_LTC.aspx.
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    OMB approved the proposal to replace the HVWDII measure with the 
HVLDL measure and remove Section O from the discharge assessment on 
February 16, 2021. The HIS V3.00 became effective on February 16, 2021 
and expires on February 29, 2024; OMB control number 0938-1153.
5. Proposal To Revise Sec.  418.312(b) Submission of Hospice Quality 
Reporting Program Data
    To address the inclusion of administrative data, such as Medicare 
claims used for hospice claims-based measures like the HVLDL and HCI in 
the HQRP and correct technical errors identified in the FY 2016 and 
2019 Hospice Wage Index and Payment Rate Update final rules, we propose 
to revise the regulation at Sec.  418.312(b) by adding paragraphs 
(b)(1) through (3). As proposed, paragraph (b)(1) would now include the 
existing language on the standardized set of admission and discharge 
items. Paragraph (b)(2) would require collection of Administrative 
Data, such as Medicare claims data, used for hospice quality measures 
to capture services throughout the hospice stay. And these data 
automatically meet the HQRP requirements for Sec.  418.306(b)(2).
    Paragraph (b)(3) would be a technical correction to address errors 
identified in the FY 2016 and FY 2019 Hospice Wage Index and Payment 
Rate Update final rules, (80 FR 47186 and 83 FR 38636). In the FY 2016 
Hospice final rule (80 FR 47186) adopted seven factors for measure 
removal, and in the FY 2019 Hospice final rule (83 FR 38636) adopted 
the eighth factor for measure removal. In those final rules, we 
referenced the measure removal factors in the preamble but 
inadvertently omitted them from the regulations text. Thus, these 
measure removal factors identify how measures are removed from the 
HQRP. Section 418.312(b)(3) would include the eight measure removal 
factors as follows:
    CMS may remove a quality measure from the Hospice QRP based on one 
or more of the following factors:

[[Page 19741]]

    (1) Measure performance among hospices is so high and unvarying 
that meaningful distinctions in improvements in performance can no 
longer be made.
    (2) Performance or improvement on a measure does not result in 
better patient outcomes.
    (3) A measure does not align with current clinical guidelines or 
practice.
    (4) The availability of a more broadly applicable (across settings, 
populations, or conditions) measure for the particular topic.
    (5) The availability of a measure that is more proximal in time to 
desired patient outcomes for the particular topic.
    (6) The availability of a measure that is more strongly associated 
with desired patient outcomes for the particular topic.
    (7) Collection or public reporting of a measure leads to negative 
unintended consequences other than patient harm.
    (8) The costs associated with a measure outweigh the benefit of its 
continued use in the program.
    We solicit public comment on our proposal to revise the regulation 
at Sec.  418.312(b) to add paragraphs (b)(1) through (3) to include 
administrative data as part of the HQRP, and correct technical errors 
identified in the FY 2016 and 2019 Hospice Wage Index and Payment Rate 
Update final rules.
6. Update Regarding the Hospice Outcomes & Patient Evaluation (HOPE) 
Development
    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 patient assessment instrument 
identified as the HOPE. This tool is intended to help hospices better 
understand care needs throughout the patient's dying process and 
contribute to the patient's plan of care. It will assess patients in 
real-time, based on interactions with the patient. The HOPE will 
support quality improvement activities and calculate outcome and other 
types of quality measures in a way that mitigates burden on hospice 
providers and patients. Our two primary objectives for the HOPE are to 
provide quality data for the HQRP requirements through standardized 
data collection, and to provide additional clinical data that could 
inform future payment refinements.
    We anticipate that the HOPE will replace the HIS. The HIS is not a 
patient assessment instrument. HIS data collection ``consists of 
selecting responses to HIS items in conjunction with patient assessment 
activities or via abstraction from the patient's clinical record.'' 
(HIS Manual v.2.01). In contrast, the HOPE is a patient assessment 
instrument, designed to capture patient and family care needs in real-
time during patient interactions throughout the patient's hospice stay, 
with the flexibility to accommodate patients with varying clinical 
needs. The HOPE will enable CMS and hospices to understand the care 
needs of people through the dying process, supporting provider care 
planning and quality improvement efforts, and ensuring the safety and 
comfort of individuals enrolled in hospice nationwide. The HOPE will 
include key items from the HIS along with Standardized Patient 
Assessment Data Elements (SPADEs), and demographics like gender and 
race. This approach to include key aspects of SPADES and demographics 
supports hospice feedback provided in the FYs 2017 and 2018 Hospice 
Wage Index and Payment Rate Update final rule (81 FR 52171 and 82 FR 
36669) and CMS' goals for a hospice assessment instrument, as stated in 
the FY 2018 Hospice Wage Index and Payment Rate Update final rule. The 
HOPE assessment instrument would facilitate communication among 
providers and to measure the care of patient populations across 
settings. While the standardization of measures required for adoption 
under the IMPACT Act of 2014 is not applicable to hospices, it makes 
reasonable sense to include those standardized elements and items that 
appropriately and feasibly apply to hospice. After all, some patients 
may move through the healthcare system to hospice so capturing and 
tracking key SPADES and social risk factor items that apply to hospice, 
including some of the categories of SPADES identified in the IMPACT Act 
of 2014, may help CMS achieve our goals for continuity of care, overall 
patient care and well-being, interoperability, and health equity that 
are also discussed in this rule.
    The draft HOPE has undergone cognitive and pilot testing, and will 
undergo field testing to establish reliability, validity and 
feasibility of the assessment instrument. We anticipate proposing the 
HOPE in future rulemaking after testing is complete.
    We will continue development of the HOPE assessment in accordance 
with the Blueprint for the CMS Measures Management System. Development 
of the HOPE is grounded in extensive information gathering activities 
to identify and refine hospice assessment domains and candidate 
assessment items. We appreciate the industry's and national 
associations' engagement in providing input through information sharing 
activities, including expert interviews, key stakeholder interviews, 
and focus groups to support the HOPE development. As CMS proceeds with 
field testing the HOPE, we will continue to engage with stakeholders 
through sub-regulatory channels. In particular, we will 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 the HOPE and related quality measures. We also have a 
dedicated email account, [email protected], for comments 
about the HOPE. We will use field test results to create a final 
version of the HOPE to propose in future rulemaking for national 
implementation. We will continue to engage all stakeholders throughout 
this process. We appreciate the support for the HOPE and reiterate our 
commitment to providing updates and engaging stakeholders through sub-
regulatory means. Future updates and engagement opportunities regarding 
HOPE can be found at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/HOPE.html.
7. Update on Quality Measure Development for Future Years
    In the FY 2017 Hospice Wage Index and Payment Rate Update final 
rule (81 FR 52160), we finalized new policies and requirements related 
to the HQRP, including how we would provide updates related to the 
development of new quality measures. Information on the current HQRP 
quality measures can be found at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures. In this proposed rule, we are continuing to provide 
updates for both HOPE-based and claims-based quality measure 
development.
    To support new measure development, our contractor, Abt Associates, 
convened TEP meetings in 2020 to provide feedback on several measure 
concepts. In 2020, the TEP explored potential quality measure 
constructs that could be derived from the HOPE and their 
specifications. Specifically, for HOPE-based measure development, the 
TEP focused on pain and other symptom outcome measure concepts that 
could be calculated from the HOPE. Input from initial TEP workgroups 
held in spring 2020 informed follow-up information-gathering activities 
related to pain in general and neuropathic pain in particular. The 2020 
Information

[[Page 19742]]

Gathering Summary report is available at https://www.cms.gov/files/document/12042020-information-gathering-oy1508.pdf. During fall 2020, 
the TEP reviewed measure concepts focusing on pain and symptom outcomes 
that could be calculated from HOPE items.
    The TEP supported further exploration and development of these 
measures. As described in the 2020 TEP Summary Report, the TEP 
generally supports the following measure concepts that are calculated 
using HOPE items: Timely Reduction of Pain Impact, Reduction in Pain 
Severity, and Timely Reduction of Symptoms. The candidate measure 
Timely Reduction of Pain Impact reports the percentage of patients who 
experienced a reduction in the impact of moderate or severe pain. HOPE 
items assessing Symptom Impact, and Patient Desired Tolerance Level for 
Symptoms or Patient Preferences for Symptom Management were used to 
calculate this measure. The candidate measure Reduction in Pain 
Severity reports the percentage of patients who had a reduction in 
reported pain severity. The primary HOPE items used to calculate this 
measure include Pain Screening, Pain Active Problem, and Patient 
Desired Tolerance Level for Symptoms or Patient Preferences for Symptom 
Management. The last candidate measure discussed by the TEP was Timely 
Reduction of Symptoms which measures the percentage of patients who 
experience a reduction in the impact of symptoms other than pain. The 
HOPE items assessing Symptom Impact, and Patient Desired Tolerance 
Level for Symptoms or Patient Preferences for Symptom Management were 
used to calculate this measure. The HOPE items for all three measure 
are collected at multiple time points across a patient's stay, 
including at Admission, Symptom Reassessment, Level of Care Change, and 
Recertification. Overall, the TEP supported each candidate measure and 
agreed that they were viable for distinguishing hospice quality. We 
continue to develop all three candidate quality measures.
    We are interested in exploring patient preferences for symptom 
management, addressing patient spiritual and psychosocial needs, and 
medication management in outcomes of care in development of quality 
measures. We seek public comment, methods, instruments, or brief 
summaries on hospice quality initiatives related to goal attainment, 
patient preferences, spiritual needs, psychosocial needs, and 
medication management.
    Information about the TEP feedback on these quality measures 
concepts and future measure concepts can be obtained via: https://www.cms.gov/files/document/2020-hqrp-tep-summary-report.pdf. Related to 
the outcome measures and in order to have HOPE pain and symptom 
measures in the program as soon as possible, we plan to develop process 
measures, including on pain and symptom management. These process 
measures may support or complement the outcome measures. We solicit 
comments on current HOPE-based quality measure development and 
recommendations for future process and outcome measure constructs.
    In the FY 2020 Hospice Wage Index and Payment Rate Update final 
rule (84 FR 38484) and as discussed below, we are interested in claims-
based quality measures in order to leverage the multiple data sources 
currently available to support quality measure development. 
Specifically, we intend to develop additional claims-based measures 
that may enable beneficiaries and their family caregivers to make more 
informed choices about hospice care and to hold hospices more 
accountable for the care they provide. As discussed in this section, 
the HVLDL and HCI claims-based measures support the Meaningful Measures 
initiative and address gaps in HQRP. Additional claim-based measure 
concepts we are considering for development include hospice services on 
weekends, transitions after hospice live discharge, Medicare 
expenditures per beneficiary (including the share of non-hospice 
spending during hospice election, and the share for hospice care prior 
to the last year of life), and post-mortem visits as measures of 
hospice quality. We intend to submit additional claims-based measures 
for future consideration and solicit public comment.
    We solicit public comment on the aforementioned HOPE- and claims-
based quality measures to distinguish between high- and low-quality 
hospices, support healthcare providers in quality improvement efforts, 
and provide support to hospice consumers in helping to select a hospice 
provider. We solicit public comment on how the candidate measures may 
achieve those goals.
    We are also considering developing hybrid quality measures that 
would be calculated using claims, assessment (HOPE), or other data 
sources. Hybrid quality measures allow for a more comprehensive set of 
information about care processes and outcomes than can be calculated 
using claims data alone. Assessment data can be used to support risk-
adjustment. We seek public comment on quality measure concepts and 
considerations for developing hybrid measures based on a combination of 
data sources.
8. CAHPS Hospice Survey Participation Requirements for the FY 2023 APU 
and Subsequent Years
a. Background and Description of the CAHPS Hospice Survey
    The CAHPS Hospice Survey is a component of the CMS HQRP which is 
used to collect data on the experiences of hospice patients and the 
primary caregivers listed in their hospice records. Readers who want 
more information about the development of the survey, originally called 
the Hospice Experience of Care Survey, may refer to 79 FR 50452 and 78 
FR 48261. National implementation of the CAHPS Hospice Survey commenced 
January 1, 2015 as stated in the FY 2015 Hospice Wage Index and Payment 
Rate Update final rule (79 FR 50452).
b. Overview of the ``CAHPS Hospice Survey Measures''
    The CAHPS Hospice Survey measures was re-endorsed by NQF on 
November 20, 2020. The re-endorsement can be found on the NQF website 
at: https://www.qualityforum.org/Measures_Reports_Tools.aspx. Use the 
QPS tool and search for NQF number 2651. The survey received its 
initial NQF endorsement on October 26, 2016 (NQF #2651). We adopted 8 
survey based measures for the CY 2018 data collection period and for 
subsequent years. These eight measures are publicly reported on a 
designated CMS website, Care Compare, https://www.medicare.gov/care-compare/.
c. Data Sources
    We previously finalized the participation requirements for the 
CAHPS Hospice Survey, (84 FR 38484). We propose no changes to these 
requirements going forward.
d. Public Reporting of CAHPS Hospice Survey Results
    We began public reporting of the results of the CAHPS Hospice 
Survey on Hospice Compare as of February 2018. Prior to the COVID-19 
public health emergency (PHE), we reported the most recent 8 quarters 
of data on the basis of a rolling average, with the most recent quarter 
of data being added and the oldest quarter of data removed from the 
averages for each data refresh. Given the exemptions provided due to 
COVID-19 PHE in the March 27, 2020 Guidance Memorandum,\52\ public 
reporting will

[[Page 19743]]

continue to be the most recent 8 quarters of data, excluding the 
exempted quarters; Quarter 1 and Quarter 2 of CY 2020. More information 
about this is detailed in the section entitled: Proposal for Public 
Reporting CAHPS-based measures with Fewer than Standard Numbers of 
Quarters Due to PHE Exemptions.
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    \52\ https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
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e. Volume-Based Exemption for CAHPS Hospice Survey Data Collection and 
Reporting Requirements
    We previously finalized a volume-based exemption for CAHPS Hospice 
Survey Data Collection and Reporting requirements for FY 2021 and every 
year thereafter (84 FR 38526).
    We propose no changes to this exemption. The exemption request form 
is available on the official CAHPS Hospice Survey website: http://www.hospiceCAHPSsurvey.org. Hospices that intend to claim the size 
exemption are required to submit to CMS their completed exemption 
request form by December 31, of the data collection year.
    Hospices that served a total of fewer than 50 survey-eligible 
decedent/caregiver pairs in the year prior to the data collection year 
are eligible to apply for the size exemption. Hospices may apply for a 
size exemption by submitting the size exemption request form as 
outlined above. The size exemption is only valid for the year on the 
size exemption request form. If the hospice remains eligible for the 
size exemption, the hospice must complete the size exemption request 
form for every applicable FY APU period, as shown in table 19.
[GRAPHIC] [TIFF OMITTED] TP14AP21.026

f. Newness Exemption for CAHPS Hospice Survey Data Collection and 
Public Reporting Requirements
    We previously finalized a one-time newness exemption for hospices 
that meet the criteria as stated in the FY 2017 Hospice Wage Index and 
Payment Rate Update final rule (81 FR 52181). In the FY 2019 Hospice 
Wage Index and Payment Rate Update final rule (83 FR 38642), we 
continued the newness exemption for FY 2023, and all subsequent years. 
We encourage hospices to keep the letter they receive providing them 
with their CMS Certification Number (CCN). The letter can be used to 
show when you received your number.
g. Survey Participation Requirements
    We previously finalized survey participation requirements for FY 
2022 through FY 2025 as stated in the FY 2018 and FY 2019 Hospice Wage 
Index and Payment Rate Update final rules (82 FR 36670 and 83 FR 38642 
through 38643). We also continued those requirements in all subsequent 
years (84 FR 38526). Table 20 restates the data submission dates for FY 
2023 through FY 2025.

[[Page 19744]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.027

    For further information about the CAHPS Hospice Survey, we 
encourage hospices and other entities to visit: https://www.hospiceCAHPSsurvey.org. For direct questions, contact the CAHPS 
Hospice Survey Team at [email protected] or call 1-(844) 
472-4621.
h. Proposal To Add CAHPS Hospice Survey Star Ratings to Public 
Reporting
    CMS currently publishes CAHPS star ratings for several of its 
public reporting programs including Home Health CAHPS and Hospital 
CAHPS. The intention in doing so is to provide a simple, easy to 
understand, method for summarizing CAHPS scores. Star ratings benefit 
the public in that they can be easier for some to understand than 
absolute measure scores, and they make comparisons between hospices 
more straightforward. The public's familiarity with a 1 through 5 star 
rating system, given its use by other programs, is also a benefit to 
using this system.
    We propose to introduce Star Ratings for public reporting of CAHPS 
Hospice Survey results on the Care Compare or successor websites no 
sooner than FY 2022. We propose that the calculation and display of the 
CAHPS Hospice Survey Star Ratings be similar to that of other CAHPS 
Star Ratings programs such as Hospital CAHPS and Home Health CAHPS. The 
stars would range from one star (worst) to five stars (best). We 
propose that the stars be calculated based on ``top-box'' scores for 
each of the eight CAHPS Hospice Survey measures. Specifically, 
individual-level responses to survey items would be scored such that 
the most favorable response is scored as 100 and all other responses 
are scored as 0. A hospice-level score for a given survey item would 
then be calculated as the average of the individual-level responses, 
with adjustment for differences in case mix and mode of survey 
administration. For a measure composed of multiple items, the hospice-
level measure score is the average of the hospice-level scores for each 
item within the measure. Similar to other CAHPS programs, we propose 
that the cut-points used to determine the stars be constructed using 
statistical clustering procedures that minimize the score differences 
within a star category and maximize the differences across star 
categories.
    We propose to use a two-stage approach to calculate these cut-
points. In the first stage, we would determine initial cut-points by 
calculating the clustering algorithm among hospices with 30 or more 
completed surveys over 2 quarters (that is, 6 months); restricting 
these calculations to hospices that meet a minimum sample size promotes 
stability of cut-points. Depending on whether hospices that meet this 
minimum sample size have different score patterns than smaller 
hospices, the initial cut-points may be too high or too low. To ensure 
that cut-points reflect the full distribution of measure performance, 
in the second stage, we would compare mean measure scores for the 
bigger hospices used in the first stage to all other hospices, and 
update cut-points by adjusting the initial cut-points to reflect the 
normalized difference between bigger and smaller hospices. This two-
stage approach allows for calculation of stable cut-points that reflect 
the full range of hospice performance. We propose that hospice star 
ratings for each measure be assigned based on where the hospice-level 
measure score falls within these cut-points.
    We further propose to calculate a summary or overall CAHPS Hospice 
Survey Star Rating by averaging the Star Ratings across the 8 measures, 
with a weight of \1/2\ for Rating of the Hospice, a weight of \1/2\ for 
Willingness to Recommend the Hospice, and a weight of 1 for each of the 
other measures, and then rounding to a whole number. We propose that 
only the overall Star Rating be publicly reported and that hospices 
must have a minimum of 75 completed surveys in order to be assigned a 
Star Rating. We propose to publish the details of the Star Ratings 
methodology on the CAHPS Hospice Survey website, 
www.hospicecahpssurvey.org. CMS requires no additional resources to 
create and display CAHPS star ratings.
    We solicit comments on these proposals for CAHPS Star Ratings and 
included in public reporting no sooner than FY 2022.

[[Page 19745]]

9. Form, Manner, and Timing of Quality Data Submission
a. Background
    Section 1814(i)(5)(C) of the Act requires that each hospice submit 
data to the Secretary on quality measures specified by the Secretary. 
Such 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 
update by 2 percentage points and then beginning in FY 2024 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.
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 CY. It is the same CY for both 
HIS and CAHPS. If the CAHPS Data Collection year is CY 2022, then the 
HIS reporting year is also CY 2022. (2) The APU is subsequently applied 
to FY payments based on compliance in the corresponding Reporting Year/
Data Collection Year. (3) For the CAHPS Hospice Survey, the Reference 
Year is the CY prior to 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 2022 
data collection year, the Reference Year, is CY 2021. This means 
providers seeking a size exemption for CAHPS in CY 2022 would base it 
on their hospice size in CY 2021. 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 21 summarizes the three timeframes described above. It 
illustrates how the CY interacts with the FY payments, covering the CY 
2020 through CY 2023 data collection periods and the corresponding APU 
application from FY 2022 through FY 2025.
[GRAPHIC] [TIFF OMITTED] TP14AP21.028

    As illustrated in Table 21, CY 2020 data submissions compliance 
impacts the FY 2022 APU. CY 2021 data submissions compliance impacts 
the FY 2023 APU. CY 2022 data submissions compliance impacts FY 2024 
APU. This CY data submission impacting FY APU pattern follows for 
subsequent years.
c. Submission Data and Requirements
    As finalized in the FY 2016 Hospice Wage Index and Payment Rate 
Update final rule (80 FR 47192), hospices' compliance with HIS 
requirements beginning with the FY 2020 APU determination (that is, 
based on HIS-Admission and Discharge records submitted in CY 2018) are 
based on a timeliness threshold of 90 percent. This means CMS requires 
that hospices submit 90 percent of all required HIS records within 30-
days of the event (that is, patient's admission or discharge). The 90-
percent threshold is hereafter referred to as the timeliness compliance 
threshold. Ninety percent of all required HIS records must be submitted 
and accepted within the 30-day submission deadline to avoid the 
statutorily-mandated payment penalty.
    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: 
www.hospicecahpssurvey.org. Table 22. HQRP Compliance Checklist 
illustrates the APU and timeliness threshold requirements.

[[Page 19746]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.029

    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 this website at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Quality-Reporting-Training-Training-and-Education-Library.
    For more information about HQRP Requirements, please visit the 
frequently-updated HQRP website and especially the Best Practice, 
Education and Training Library, and Help Desk web pages at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting. We also encourage members of the 
public to go to the HQRP web page and sign-up for the Hospice Quality 
ListServ to stay informed about HQRP.
d. Update on Transition to iQIES
    In the FY 2020 Hospice Wage Index and Payment Rate Update final 
rule (84 FR 38484), we finalized the proposal to migrate our systems 
for submitting and processing assessment data. Hospices are currently 
required to submit HIS data to CMS using the Quality Improvement and 
Evaluation System (QIES) Assessment and the Submission Processing 
(ASAP) system. The FY 2020 Hospice Wage Index and Payment Rate Update 
final rule (84 FR 38484) finalized the proposal to migrate to a new 
internet Quality Improvement and Evaluation System (iQIES) that will 
enable us to make real-time upgrades. We are designating that system as 
the data submission system for the Hospice QRP. We will notify the 
public about any system migration updates using subregulatory 
mechanisms such as web page postings, listserv messaging, and webinars.
10. Public Display of ``Quality Measures'' and Other Hospice Data for 
the HQRP
a. Background
    Under section 1814(i)(5)(E) of the Act, the Secretary is required 
to establish procedures for making any quality data submitted by 
hospices available to the public. These procedures shall ensure that 
individual hospices have the opportunity to review their data prior to 
these data being made public on our designated public website. To meet 
the Act's requirement for making quality measure data public, we 
launched Hospice Compare in August 2017. This website allows consumers, 
providers, and other stakeholders to search for all Medicare-certified 
hospice providers and view their information and quality measure 
scores. In September 2020, CMS transitioned Hospice Compare to the Care 
Compare website. Hospice Compare was discontinued in December 2020. 
Care Compare supports all Medicare settings and fulfills the Act's 
requirements for the HQRP. For more information about Care Compare, 
please see the Update on the Hospice Quality Reporting Requirements for 
FY 2022 in section D.
    Since 2017, we have increased and improved available information 
about the care hospices provide for consumers. To indicate the quality 
of care hospices provide, we first posted the seven HIS Measures (NQF 
#1641, NQF #1647, NQF #1634, NQF #1637, NQF #1639, NQF #1638, and NQF 
#1617) in 2017, and then added the CAHPS Hospice Survey measure (NQF 
#2651) and the HIS Comprehensive Assessment at Admission (NQF #3235) in 
2018. In 2019, we added the Hospice Visits When Death is Imminent 
(Measure 1) to the website.
    As discussed above, we propose to remove the seven HIS Measures 
from public reporting on Care Compare no earlier than May 2022. The 
Hospice Item Set V3.00 PRA Submission replaced the HVWDII measure with 
a more robust version: The claims-based measure HVLDL. We propose to 
publicly report the HVLDL no earlier than May 2022. We are also 
proposing to publicly report the HCI, another claims-based measure no 
earlier than May 2022. In addition to the publicly-reported quality 
measure data, in 2019 we added to public reporting, information about 
the hospices' characteristics, taking raw data available from the 
Medicare Public Use File and other publicly-available government data 
sources and making them more consumer friendly and accessible for 
people seeking hospice care for themselves or family members, (83 FR 
38649). This publicly reported information currently includes 
diagnoses, location of care, and levels of care provided.

[[Page 19747]]

b. Proposal Regarding Data Collection and Reporting During a Public 
Health Emergency
(1). Background: COVID-19 Public Health Emergency Temporary Exemption 
and Its Impact on the Public Reporting Schedule
    Under authority of section 319 of the Public Health Service (PHS) 
Act, the Secretary declared a Public Health Emergency (PHE) effective 
as of January 27, 2020. On March 13, 2020, the President declared a 
national state of emergency under the Stafford Act, effective March 1, 
2020, allowing the Secretary to invoke section 1135(b) of the Act (42 
U.S.C. 1320b-5) to waive or modify the requirements of titles XVIII, 
XIX, and XXI of the Act and regulations to the extent necessary to 
address the COVID-19 PHE. Many waivers and modifications were made 
effective as of March 1, 2020 53 54 in accordance with the 
president's declaration. On March 27, 2020, we sent a guidance 
memorandum under the subject title, ``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'' \55\ to the Medicare Learning Network (MLN) Connects 
Newsletter and Other Program-Specific Listserv Recipients,\56\ 
hereafter referred to as the March 27, 2020 CMS Guidance Memorandum. In 
that memo, which applies to HIS and CAHPS Hospice Survey, CMS granted 
an exemption to the HQRP reporting requirements for Quarter 4 (Q4) 2019 
(October 1, 2019 through December 31, 2019), Quarter 1 (Q1) 2020 
(January 1, 2020 through March 30, 2020), and Quarter 2 (Q2) 2020 
(April 1, 2020 through June 30, 2020). We discuss the impact to the HIS 
here, and the impact to the CAHPS Hospice Survey further below. For 
HIS, the quarters are defined based on submission of HIS admission or 
discharge assessments.
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    \53\ Azar, A.M. (2020 March 15). Waiver or Modification of 
Requirements Under Section 1135 of the Social Security Act. Public 
Health Emergency. https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
    \54\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
    \55\ https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
    \56\ (2020, March 27). 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. Centers for Medicare & Medicaid Services. https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
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    The exemption has impacted the public reporting schedule. Since 
launching Hospice Compare in 2017, HIS-measures have been reported 
using 4 quarters of data. The 4 quarters included are the most recent 
data that have gone through Review and Correct processes, have been 
issued in a provider preview report, and have time allotted for 
addressing requests for data suppression before being publicly 
reported. As discussed in the FY 2017 Hospice Wage Index and Payment 
Rate Update final rule (81 FR 52183), CMS requires at least 4 quarters 
of data to establish the scientific acceptability for our HIS-based 
quality measures. For CAHPS-based measures, we have reported CAHPS 
measures using eight rolling quarters of data on Hospice Compare since 
2018. In the FY 2017 Hospice Wage Index and Payment Rate Update final 
rule (81 FR 52143), we stated that we would continue CAHPS reporting 
with eight rolling quarters on an ongoing basis. This original public 
reporting schedule included the exempted quarters of Q4 2019 and Q1 and 
Q2 2020 in six refreshes for HIS and 11 refreshes for CAHPS. Table 23 
displays the original schedule for public reporting prior to the COVID-
19 PHE.

[[Page 19748]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.030

    During the spring and summer of 2020, we conducted testing to 
inform decisions about publicly reporting data for those refreshes 
which include exempt data. The testing helped us develop a plan for 
posting data as early as possible, for as many hospices as possible, 
and with scientific acceptability similar to standard threshold for 
public reporting. The following sections provide the results of our 
testing and explain how we used the results to develop a plan that we 
believe allows us to achieve these objectives as best as possible.
(2). Update on Use of Q4 2019 Data and Data Freeze for Refreshes in 
2021
    In the March 27, 2020 Guidance Memorandum, we stated that we should 
not include any post-acute care (PAC) quality data that are greatly 
impacted by the exemption in the quality reporting programs. Given the 
timing of the PHE onset, we determined that we would use any data that 
was submitted for Q4 2019. We conducted analyses of those data to 
ensure that their use was appropriate. In the original schedule (Table 
23) the November 2020 refresh includes Q4 2019 data for HIS- and CAHPS-
based measures (Q1 through Q4 2019 for HIS data and Q1 2018 through Q4 
2019 for CAHPS data) and is the last refresh before Q1 2020 data are 
included. Before proceeding with the November 2020 refresh, we 
conducted testing to ensure that, even though we made an exception to 
reporting requirements for Q4 2019 in March 2020, public reporting 
would still allow us to publicly report data for a similar number of 
hospice providers, as compared to standard reporting. Specifically, we 
compared submission rates in Q4 2019 to average annual rates (Q4 2018 
through Q3 2019) to assess the extent to which hospices had taken 
advantage of the exemption, and thus the extent to which data and 
measure scores might be affected. We observed that the HIS data 
submission rate for Q4 2019 was in fact 1.8 percent higher than the 
previous CY (Q4 2018). For the CAHPS Hospice Survey, 2.1 percent more 
hospices submitted data in Q4 2019 than in Q4 2018. We note that Q4 
2019 ended before the onset of the COVID-19 PHE in the United States 
(U.S.). Thus, we proceeded with including these data in measure 
calculations for the November 2020 refresh.
    As for Q1 and Q2 2020, we determined that we would not use HIS or 
CAHPS data from these quarters for public reporting given the timing of 
the PHE onset. All refreshes, during which we decided to hold these 
data constant, included more than 2 quarters of data that were affected 
by the CMS-issued COVID reporting exceptions; thus we did not have an 
adequate amount of data to reliably calculate and publicly display 
provider measures scores. Consequently, we determined to freeze the 
data displayed, that is, holding data constant after the November 2020 
refresh without subsequently updating the data through November 2021. 
This decision was communicated to the public in a Public Reporting Tip 
Sheet, which is located at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/HQRP-Requirements-and-Best-Practices.

[[Page 19749]]

(3). Proposal for Public Reporting of HIS-Based Measures With Fewer 
Than Standard Numbers of Quarters Due to PHE Exemption in February 2022
    As noted above, we used Q4 2019 data for public reporting in 
November 2020 and froze that data for the February, May, August, and 
November 2021 refreshes. This addressed five of the six PHE-affected 
quarters for HIS-based measures, and five of the 11 PHE-affected 
quarters of CAHPS-based measures.
    Because November 2020 refresh data will become increasingly out-of-
date and thus less useful for consumers, we analyzed whether it would 
be possible to use fewer quarters of data for the last refresh affected 
by the exemption (February 2022) and thus more quickly resume public 
reporting with updated quality data. Using fewer quarters of more 
recent data, the first option, would require that (1) a sufficient 
percentage of providers would still likely have enough assessment data 
to report quality measures (reportability); and (2) fewer quarters 
would likely produce similar measure scores for hospices, and thus not 
unfairly represent the quality of care hospices provide during the 
period reported in a given refresh (reliability). To assess these 
criteria, we conducted reportability and reliability analysis using 3 
quarters of data in a refresh, instead of the standard 4 quarters of 
data for reporting HIS-based measures. Specifically, we used historical 
data to calculate HIS-based quality measures under two scenarios:
     Standard Public Reporting (SPR) Scenario: We used data 
from the four quarters of CY 2019, which represent CY 2020 public 
reporting in the absence of the temporary exemption from the submission 
of PAC quality data, as the basis for comparing simulated alternatives. 
For HIS-based measures, we used quarters Q1 through Q4 2019.
     COVID-19 PHE Affected Reporting (CAR) Scenario: We 
calculated quality measures using Q2 2019, Q3 2019, and Q4 2019 data, 
to simulate using only Q3 2020, Q4 2020, and Q1 2021 data for public 
reporting.
    The HIS Comprehensive Assessment Measure is based on the receipt of 
care processes at the time of admission. Therefore for the COVID-19 
Affected Reporting (CAR) Scenario, we excluded data for patient stays 
with admission dates in Q1 2019.
    For each scenario, we calculated the reportability as the percent 
of hospices meeting the 20-case minimum for public reporting (the 
public reporting threshold). To test the reliability of restricting the 
providers included in the Standard Public Reporting (SPR) Scenario to 
those included in the CAR Scenario, we performed three tests. First, we 
evaluated measure correlation using the Pearson and Spearman 
correlation coefficients, which assess the alignment of hospices' HIS 
Comprehensive Assessment Measure scores between scenarios. Second, for 
each scenario, we conducted a split-half reliability analysis and 
estimated intra-class correlation (ICC) scores, where higher scores 
imply better internal reliability. Modest differences in ICC scores 
between scenarios would suggest that using fewer quarters of data does 
not impact the internal reliability of the results. Third, we estimated 
reliability scores. A higher value in these scores indicates that HIS 
Comprehensive Assessment Measure values are relatively consistent for 
patients admitted to the same hospice and variation in the measure 
reflects true differences across providers.
    Testing results show that the CAR scenario--specifically using 3 
quarters of data for the HIS Comprehensive Assessment Measure--
demonstrates acceptable levels of reportability and reliability. As 
displayed in Table 24, the number of providers who met the public 
reporting threshold for the HIS Comprehensive Assessment Measure 
decreases by 236 (or by 5.2 percentage points) when reporting three 
versus four quarters of data. In the FY 2014 Hospice Wage Index and 
Payment Rate Update final rule (78 FR 48234) we stated that 
reportability of 71 percent through 90 percent is acceptable. Therefore 
using 3 quarters of data for the HIS Comprehensive Assessment Measure 
would achieve acceptable reportability shown in Table 24.
[GRAPHIC] [TIFF OMITTED] TP14AP21.031

    Table 24 indicates that the reliability of the HIS Comprehensive 
Assessment Measure scores is similar for the CAR and SPR scenarios. 
Testing also yielded correlation coefficients above 0.9, indicating a 
high degree of agreement between hospices' HIS Comprehensive Assessment 
Measure scores when using 3 or 4 quarters of data. The results also 
show that the HIS Comprehensive Assessment Measure's ICC for CAR and 
SPR scenarios are similar, with only a 0.02 difference. This implies 
high internal reliability of the measure in both scenarios. The median 
reliability scores for the HIS Comprehensive Assessment Measure are 
also very similar in both CAR and SPR scenarios. This indicates that 
scores estimated using 3 quarters of data continue to capture provider-
level differences and that admission-level scores remain consistent 
within hospices.

[[Page 19750]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.032

    In Table 25, we explore changes in hospices' relative rankings 
between the SPR and CAR scenarios. For each scenario, we divided 
hospices in quintiles based on their HIS Comprehensive Assessment 
Measure score, such that higher scores are in a higher quintile. 
Changes in a hospices' quintile from the SPR to CAR scenario would 
indicate a re-ranking of hospices when using 3 quarters compared to 4 
quarters. Over 93 percent of hospices remain in the same quintile, 
suggesting that the ranking of hospices is fairly stable between the 
SPR and CAR scenarios.
[GRAPHIC] [TIFF OMITTED] TP14AP21.033

    We also used the results presented in Table 26 to assess the option 
of reporting Q4 2019, Q3 2020, Q4 2020, and Q1 2021 for the February 
2022 refresh. This option maintains requirements in the FY 2017 Hospice 
Wage Index and Payment Update final rule for publicly reporting 4 
quarters of data, but it requires using some data that are more than 2 
years old. Also, the relatively high number of hospices that meet the 
public reporting threshold in the CAR scenario, relative to the SPR 
scenario, with just 3 quarters of data justify the use of 3 quarters in 
the unusual circumstances of the PHE and its associated exemptions.
    We propose that, in the COVID-19 PHE, we would use 3 quarters of 
HIS data for the final affected refresh, the February 2022 public 
reporting refresh of Care Compare for the Hospice setting. Using 3 
quarters of data for the February 2022 refresh would allow us to begin 
displaying Q3 2020, Q4 2020, and Q1 2021 data in February 2022, rather 
than continue displaying November 2020 data (Q1 2019 through Q4 2019). 
We believe that updating the data in February 2022 by more than a year 
relative to the November 2020 freeze data would assist consumers by 
providing more relevant quality data and allow hospices to demonstrate 
more recent performance. Our testing results indicate we can achieve 
these positive impacts while maintaining high standards for 
reportability and reliability. Table 27 summarizes the comparison 
between the original schedule for public reporting with the revised 
schedule (that is, frozen data) and with the proposed schedule that is, 
using 3 quarters in the February 2022 refresh.
    We seek public comment on this proposal to use 3 quarters of HIS 
data for the February 2022 public reporting refresh.

[[Page 19751]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.034

(4). Proposal for Public Reporting of ``CAHPS Hospice Survey-Based 
Measures'' Due to PHE Exemption
    Prior to COVID-19 PHE, the CAHPS Hospice Survey publicly reported 
the most recent eight rolling quarters of data. We propose to continue 
to report the most recent 8 quarters of available data after the 
freeze, but not to include the data from the exempted quarters of Q1 
and Q2 of 2020 as issued in the March 27, 2020 Guidance Memorandum with 
the effected quarters discussed above. The optional data submission for 
Q4 2019 results in publicly reporting of that data since the CAHPS 
Hospice Survey from that quarter were not impacted. The data submitted 
for Q4 2019 referred to deaths that occurred prior to COIVD-19. For the 
CAHPS Hospice Survey, 2.1 percent more hospices submitted data in Q4 
2019 than in the same quarter a year earlier.
    Like HIS, our goal is to report as much of the most recent CAHPS 
Hospice Survey data as possible, to display data for as many hospices 
as possible, and to maintain the reliability of the data.
    Similar to HIS, the CAHPS Hospice Survey reviewed the data for 
reportability using fewer quarters than normal. However, we found that 
using fewer than 8 quarters of data would have two important negative 
impacts on public reporting. First, it would reduce the proportion of 
hospices that would have CAHPS Hospice Survey data displayed on Care 
Compare. An analysis of the 8 quarters of data from Q1 2018 through Q4 
2019 (publicly reported in November 2020) shows there were 5,041 active 
hospices. Of these hospices: 2,941 (58.3 percent) had 30+ completes for 
those 8 quarters, and had scores publicly reported. Fewer hospices, 
2,328 (46.2 percent), would have had 30+ completes if 4 quarters of 
data were used to calculate scores and 1,970 (39.1 percent) would have 
30+ completes if 3 quarters were used to calculate scores. In addition, 
the overall reliability of the CAHPS scores would decline with fewer 
quarters of data. For these reasons, we determined the best course of 
action would be to continue to publicly report the most recent 8 
quarters of data, but exempting Q1 and Q2 2020. This will allow us to 
maximize the number of hospices that will have CAHPS scores displayed 
on Care Compare, protect the reliability of the data, and report as 
much of the most recent data as possible.
    CMS froze CAHPS data starting with the November 2020 refresh and 
concluding with the November 2021 refresh. We propose that starting 
with the February 2022 refresh, CMS will display the most recent 8 
quarters of CAHPS Hospice Survey data, excluding Q1 and Q2 2020. We 
will resume public reporting by displaying 3 quarters of post-exemption 
data, plus five quarters of pre-exemption data. (Please see Table 28.) 
We propose that in each refresh subsequent to February 2022, we will 
report one more post-exemption quarter of data and one fewer pre-
exemption quarter of data until we reach eight quarters of post-
exemption data in May of 2023. We further propose that as of August 
2023, we will resume reporting a rolling average of the most recent 8 
quarters of data. Table 28 specifies the quarters for each refresh. 
This will allow us to report the maximum amount of new data, maintain 
reliability of the data, and permit the maximum number of hospices to 
receive scores. In addition, Table 28 shows the proposed CAHPS public 
reporting schedule during and after the data freeze.

[[Page 19752]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.035

    We seek public comment on this proposal to publicly report the 
most-recently available 8 quarters of CAHPS data starting with the 
February 2022 refresh and going through the May 2023 refresh on Care 
Compare because we cannot publicly report Q1 2020 and Q2 2020 data due 
to the COVID-19 PHE.
c. Quality Measures To Be Displayed on Care Compare in FY 2022 and 
Beyond
(1). Proposal To Remove Seven ``Hospice Item Set Process Measures'' 
From Public Reporting
    As discussed earlier, we are proposing to remove the seven HIS 
process measures from the HQRP as individual measures, and no longer 
applying them to the FY 2024 APU and thereafter. We propose to remove 
the seven HIS process measures no earlier than May 2022 refresh from 
public reporting on Care Compare and from the Preview Reports but 
continue to have it publicly available in the data catalogue at https://data.cms.gov/provider-data/topics/hospice-care. We are seeking public 
comment on this proposal to remove the seven HIS process measures from 
public reporting on Care Compare.
(2). Proposals for Calculating and Publicly Reporting ``Claims-Based 
Measure'' as Part of the HQRP
    In the HIS V3.00 Paperwork Reduction Act Submission (OMB control 
number: 0938-1153, CMS-10390), we finalized a proposal to adopt HVLDL 
into the HQRP for FY 2021. We are also proposing in this rule, 
discussed above, to adopt the HCI into the HQRP for FY2022. In this 
section, we present four proposals related to calculating and reporting 
claims-based measures, with specific application to HVLDL and HCI. 
First, we propose to extract claims data to calculate claims-based 
measures at least 90 days after the last discharge date in the 
applicable period, which we will use for quality measure calculations 
and public reporting on Care Compare. For example, if the last 
discharge date in the applicable period for a measure is December 31, 
2022, for data collection January 1, 2022, through December 31, 2022, 
we would create the data extract on approximately March 31, 2023, at 
the earliest. We would use those data to calculate and publicly report 
the claims-based measures for the CY2022 reporting period. This 
proposal is similar to those finalized in other PAC settings, including 
the CY 2017 Home Health Prospective Payment System final rule (81 FR 
76702), FY 2017 Inpatient Rehabilitation Facility Prospective Payment 
System final rule (81 FR 52056), and the FY 2017 Long Term Care 
Hospital Prospective Payment System final rule (81 FR 56762).
    The proposed timeframe allows us to balance providing timely 
information to the public with calculating the claims-based measures 
using as complete a data set as possible. We recognize that the 
proposed approximately 90-day ``run-out'' period is shorter than the 
Medicare program's current timely claims filing policy under which 
providers have up to 1 year from the date of discharge to submit 
claims. However, several months lead-time is necessary after acquiring 
the data to conduct the claims-based calculations. If we were to delay 
our data extraction point to 12 months after the last date of the last 
discharge in the applicable period, we would not be able to deliver the 
calculations to hospices sooner than 18 to 24 months after the last 
discharge.
    To implement this process, hospices would not be able to submit 
corrections to the underlying claims snapshot or add claims (for those 
claims-based measures) to this data set at the

[[Page 19753]]

conclusion of the 90-day period following the last date of discharge 
used in the applicable period. Therefore, we would consider the hospice 
claims data to be complete for purposes of calculating the claims-based 
measures at this point. Thus, it is important that hospices ensure the 
completeness and correctness of their claims prior to the claims 
``snapshot.''
    Second, we propose that we will update the claims-based measures 
used for the HQRP annually. Specifically, we will refresh claims-based 
measure scores on Care Compare, in preview reports, and in the 
confidential CASPER QM preview reports annually. This periodicity of 
updates aligns with most claims-based measures across PAC settings.
    Third, we propose that we will calculate claims-based measure 
scores based on one or more years of data. We considered several 
factors to determine the number of years to include in measure 
calculations. Using only 1 year (4 quarters) of data, as is currently 
done for HIS-based quality measures reported on Care Compare, allows us 
to share with the public only the most up-to-date information and best 
reflects current realities. Having only the most recent data can also 
help incentivize hospices with lower scores to make changes and have 
the results of their effort be reflected in better scores.
    At the same time, we want to report measures scores to the public 
for as many hospices as possible, including small hospices. Currently, 
only Medicare-certified hospices with more than 20 discharges each year 
have quality measure results publicly available on Care Compare. This 
public reporting threshold protects the privacy of patients who seek 
care at smaller hospices. However, due to the threshold, at least some 
hospices will not achieve the minimum patient discharges within 1 year. 
This means that their scores will not be displayed on Care Compare, and 
consumers will not have information about them to inform their 
decisions about selecting a hospice. Using more years of data allows 
more of these hospices to meet this threshold.
    We conducted reportability testing for HCI and HVLDL to help us 
consider how best to balance the need for recent data with the need for 
transparency in reporting the HQRP claims-based measures. Specifically, 
we conducted a simulation using 2 years of data. We then calculated the 
change in the number of hospices which achieved the minimum reporting 
standard. We also compared the measure scores of the hospices that meet 
the reporting threshold when we use 2 years of data with hospices that 
meet the threshold using only 1 year of data.
    Results for both HCI and HVLDL indicate that using 2 years of data 
increases reportability. For HVLDL, combining 2 years of data (FY 2018 
to FY 2019) allows an additional 326 hospices to share measure scores, 
or 33.8 percent of the hospices that do not meet the reporting 
threshold in FY 2019 alone. For HCI, combining 2 years of data (FY 2018 
to FY 2019 data) allows an additional 277 to report HCI measure scores 
on Care Compare, or 43.2 percent of the hospices that do not meet the 
reporting threshold in FY 2019 alone.
[GRAPHIC] [TIFF OMITTED] TP14AP21.036

    Our simulations indicate that the hospices that only meet the 
reporting threshold when using 2 years of data have performance scores 
substantially lower than average. For HVLDL, where higher scores 
indicate better quality of care, the national average score was 65.5 
percent in FY 2019, where 965 hospices did not meet the reportability 
threshold. After pooling data using FY 2018 to FY 2019, 326 additional 
hospices met the reportability threshold, or 33.8 percent of those 
previously missing. Those addition 326 hospices had an average HVLDL 
score of just 43.3 percent, about 20 percentage points lower than the 
hospices meeting the reportability threshold using FY 2019 alone 
national average score for this HVLDL measure.
    The results for HCI similarly show that the hospices with 
reportable data when using two-pooled years of data had lower HCI 
scores compared to the national average when using just FY 2019 data. 
Higher HCI scores indicate better performance. As Figure 7 shows, a 
larger numbers of hospices among the 277 hospices that only meet the 
reporting threshold when using 2 years of data had HCI scores between 
four and eight, while a larger number of hospices in the FY 2019 
population had a perfect score of 10.

[[Page 19754]]

[GRAPHIC] [TIFF OMITTED] TP14AP21.037

    Given these findings, we propose using 2 years of data to publicly 
report HCI and HVLDL in 2022. The use of 2 years or 8 quarters of 
quality data is already publicly reported for the quality measures 
related to the CAHPS Hospice Survey so hospices are familiar with this 
approach. We plan to consider multiple years of data, like the 2 years 
of data, for other claims-based measures proposed in subsequent years. 
We believe it is important to support consumers by sharing information 
on the performance of hospices that have lower scores, and to 
incentivize those hospices to improve. The results demonstrate that 
using multiple years of data help include more hospices that have lower 
performance rates for HVLDL and HCI in public reporting on Care 
Compare. While using more years of data would allow us to report 
measures for even more hospices, it would involve sharing data that are 
no longer relevant, and display scores that do not reflect recent 
hospice improvement efforts.
    We are soliciting public comment on these proposals related to the 
using 2 years of data for claims-based measures and public reporting of 
claims measures in general and their application to HVLDL and HCI 
specifically.
(3). Proposal To Publicly Report the Hospice Care Index and ``Hospice 
Visits in the Last Days of Life'' Claims-Based Measures
    As discussed previously, we are proposing to publicly report the 
HCI and HVLDL using 2 years, which is 8 quarters of Medicare claims 
data. We propose to publicly report the HCI and HVLDL beginning no 
earlier than May 2022 using FY2021 Medicare hospice claims data, and to 
include it in the Preview Reports no sooner than the May 2022 refresh. 
The publicly-reported version of HCI on Care Compare will only include 
the final HCI score, and not the component indicators. The Preview 
Reports will reflect the HCI as publicly reported. We are seeking 
public comment on this proposal for HCI and HVLDL public reporting on 
Care Compare no sooner than May 2022.
(4). Update on Publicly Reporting for the ``Hospice Visits When Death 
is Imminent (HVWDII) Measure 1'' and the ``Hospice Visits in the Last 
Days of Life (HVLDL) Measure''
    As discussed earlier, the HIS V3.00 PRA Submission, CMS-10390 (OMB 
control number: 0938-1153), finalized the proposal to replace the 
HVWDII measure pair with a re-specified version called HVLDL, which is 
a single measure based on Medicare claims. Relatedly, in the HIS V3.00 
PRA Submission, CMS-10390 (OMB control number: 0938-1153), we finalized 
the proposal to remove Section O from the HIS. As stated in section 
1814(i)(5)(E) of the Act, we establish procedures for making all 
quality data submitted by hospices under Sec.  418.312 available to the 
public. Thus, we would have continued to publicly report HVWDII Measure 
1 data through the November 2021 refresh. Because of the data freeze 
detailed above, HVWDII Measure 1 data from the November 2020 refresh, 
covering HIS admissions during Q1 through Q4 2019, will be publicly 
displayed for all calendar year 2021 refreshes. We may retain the 
November 2020 refresh for HVWDII Measure 1 for one or more refreshes in 
2022, when there will be no HIS Section O data, if doing so will allow 
us to consolidate changes and thus operate more efficiently.
d. Update on Transition From Hospice Compare to Care Compare and 
Provider Data Catalog
    In September 2020, we launched Care Compare, a streamlined redesign 
of eight existing CMS healthcare compare tools available on 
Medicare.gov, including Hospice Compare. Care Compare provides a single 
user-friendly interface that patients and family caregivers can use to 
make informed

[[Page 19755]]

decisions about healthcare based on cost, quality of care, volume of 
services, and other data. With just one click, patients can find 
information that is easy to understand about doctors, hospitals, 
nursing homes, and other health care services instead of searching 
through multiple tools.
    For the last six years, Medicare's Hospice Compare has served as 
the cornerstone for publicizing quality care information for patients, 
family caregivers, consumers, and the healthcare community. The new 
website builds on the eMedicare initiative to deliver simple tools and 
information to current and future Medicare beneficiaries. Drawing on 
lessons learned through research and stakeholder feedback, Care Compare 
includes features and functionalities that appeal to Hospice Compare 
consumers. By offering an accessible and user-friendly interface and a 
simple design that is optimized for mobile and tablet use, it is easier 
than ever to find information that is important to patients when 
shopping for healthcare. Enhancements for mobile use will give 
practical benefits like accessing the tool using a smartphone that can 
initiate phone calls to providers simply by clicking on the provider's 
phone number.
    In conjunction with the Care Compare launch, we have made 
additional improvements to other CMS data tools, to help Medicare 
beneficiaries compare costs. Specifically, the Provider Data Catalog 
(PDC) better serves innovators and stakeholders who are interested in 
detailed CMS data and use interactive and downloadable datasets like 
those currently available on data.Medicare.gov. The PDC now makes 
quality datasets available through an improved Application Programming 
Interface (API), allowing innovators in the field to easily access and 
analyze the CMS publicly-reported data and make it useful for patients.
e. Update on Additional Information on Hospices for Public Reporting
    In the FY 2019 Hospice Wage Index and Payment Rate Update and 
Hospice Quality Reporting Requirements final rule (83 FR 38622), we 
finalized plans to publicly post information from the Medicare Provider 
Utilization and Payment Data: Hospice Public Use File (PUF) and other 
publicly-available CMS data to Hospice Compare or another CMS website. 
Hospice PUF data are available for CY 2014 through CY 2016. Beginning 
with CY 2017 data, hospice PUF data are public as part of the Post-
Acute Care and Hospice Provider Utilization and Payment PUF (hereafter 
PAC PUF). For more information, please visit the PAC PUF web page at: 
https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/PAC2017. Both the 
Hospice and PAC PUFs provide information on services provided to 
Medicare beneficiaries by hospice providers. Specifically, they contain 
information on utilization, payment (Medicare payment and standard 
payment), submitted charges, primary diagnoses, sites of service, and 
beneficiary demographics organized by CCN (6-digit provider 
identification number) and state.
    PUF data, along with clear text explaining the purpose and uses of 
this information and suggesting consumers discuss this information with 
their healthcare provider, first displayed in a consumer-friendly 
format on Hospice Compare in May 2019. Beginning May 2021, we will 
begin to display additional information from the PAC PUF on Care 
Compare. This additional information includes hospices' beneficiary 
characteristics such as the percentage of patients enrolled in Medicare 
Advantage. In addition, consumers will see whether a hospice provided 
services to Medicare Advantage enrollees or patients who have coverage 
under both Medicaid and Medicare, also called dual eligible patients. 
The data for these additional characteristics are pulled directly from 
the PAC PUF file and provide potential hospice service patients and 
family caregivers with more detail prior to selecting a hospice.
    As finalized in the FY 2019 Hospice Wage Index and Payment Update 
final rule (83 FR 38622), we also improved access to publicly-available 
information about hospices' compliance with Hospice QRP requirements. 
Specifically, we already post the annual Hospice APU Compliant List on 
the HQRP Requirements and Best Practices web page. This document 
displays the CCN, name, and address of every hospice that successfully 
met quality reporting program requirements for the fiscal year. 
Hospices are only considered compliant if they meet the standards for 
HIS and CAHPS reporting, as codified in Sec.  418.312. Consumers can 
now access the Hospice APU compliance file from Care Compare, enabling 
them to determine if a particular hospice is compliant with CMS' 
quality reporting requirements.

G. Proposal for the January 2022 HH QRP Public Reporting Display 
Schedule With Fewer Than Standard Number of Quarters Due to COVID-19 
Public Health Emergency Exemptions

1. Background and Statutory Authority
    We include this Home Health proposal in this rule because we plan 
to resume public reporting for the HH QRP with the January 2022 refresh 
of Care Compare. In order to accommodate the exception of 2020 Q1 and 
Q2 data, we are proposing to resume public reporting using 3 out of 4 
quarters of data for the January 2022 refresh. In order to finalize 
this proposal in time to release the required preview report related to 
the refresh, which we release 3 months prior to any given refresh 
(October 2021), we need the rule containing this proposal to finalize 
by October 2021.
    The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act. 
Section 1895(b)(3)(B)(v)(II) of the Act requires that for 2007 and 
subsequent years, each HHA submit to the Secretary in a form and 
manner, and at a time, specified by the Secretary, such data that the 
Secretary determines are appropriate for the measurement of health care 
quality. To the extent that an HHA does not submit data in accordance 
with this clause, the Secretary shall reduce the home health market 
basket percentage increase applicable to the HHA for such year by 2 
percentage points. As provided at section 1895(b)(3)(B)(vi) of the Act, 
depending on the market basket percentage increase applicable for a 
particular year, the reduction of that increase by 2 percentage points 
for failure to comply with the requirements of the HH QRP and further 
reduction of the increase by the productivity adjustment (except in 
2018 and 2020) described in section 1886(b)(3)(B)(xi)(II) of the Act 
may result in the home health market basket percentage increase being 
less than 0.0 percent for a year, and may result in payment rates under 
the Home Health PPS for a year being less than payment rates for the 
preceding year. For more information on the policies we have adopted 
for the HH QRP, we refer readers to the following rules:
     CY 2007 HH PPS final rule (71 FR 65888 through 65891).
     CY 2008 HH PPS final rule (72 FR 49861 through 49864).
     CY 2009 HH PPS update notice (73 FR 65356).
     CY 2010 HH PPS final rule (74 FR 58096 through 58098).
     CY 2011 HH PPS final rule (75 FR 70400 through 70407).
     CY 2012 HH PPS final rule (76 FR 68574).

[[Page 19756]]

     CY 2013 HH PPS final rule (77 FR 67092).
     CY 2014 HH PPS final rule (78 FR 72297).
     CY 2015 HH PPS final rule (79 FR 66073 through 66074).
     CY 2016 HH PPS final rule (80 FR 68690 through 68695).
     CY 2017 HH PPS final rule (81 FR 76752).
     CY 2018 HH PPS final rule (82 FR 51711 through 51712).
     CY 2019 HH PPS final rule with comment period (83 FR 
56547).
     CY 2020 HH PPS final rule (84 FR 60554 through 60611).
     CY 2021 HH PPS final rule (85 FR 70326 through 70328).
2. Public Display of Home Health Quality Data for the HH QRP
    Section 1895(b)(3)(B)(v)(III) of the Act requires the Secretary to 
establish procedures for making HH QRP data, including data submitted 
under sections 1899B(c)(1) and 1899B(d)(1) of the Act, available to the 
public. Such public display procedures must ensure that HHAs have the 
opportunity to review the data that will be made public with respect to 
each HHA prior to such data being made public. Section 1899B(g) of the 
Act requires that data and information regarding PAC provider 
performance on quality measures and resource use or other measures be 
made publicly available beginning not later than 2 years after the 
applicable specified ``application date''.
    We established our HH QRP Public Display Policy in the CY 2016 HH 
PPS final rule (80 FR 68709 through 68710). In that final rule, we 
noted that the procedures for HHAs to review and correct their data on 
a quarterly basis is performed through CASPER along with our procedure 
to post the data for the public on our Care Compare website. We have 
communicated our public display schedule, which supports our Public 
Display Policy, on our websites whereby the quarters of data included 
are announced.
3. Proposal To Modify HH QRP Public Reporting To Address CMS' Guidance 
To Except Data During the COVID-19 PHE Beginning January 2022 Through 
July 2024
    We are proposing to modify our public display schedule to display 
fewer quarters of data than what we previously finalized for certain HH 
QRP measures for the January 2022 refreshes. Under authority of section 
319 of the PHS Act, the Secretary declared a PHE effective as of 
January 27, 2020. On March 13, 2020, the President declared a national 
state of emergency under the Stafford Act, effective March 1, 2020, 
allowing the Secretary to invoke section 1135(b) of the Act (42 U.S.C. 
1320b-5) to waive or modify the requirements of titles XVIII, XIX, and 
XXI of the Act and regulations to the extent necessary to address the 
COVID-19 PHE. Many waivers and modifications were made effective as of 
March 1, 2020 in accordance with the President's declaration.\57\
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    \57\ Azar, A.M. (2020 March 15). Waiver or Modification of 
Requirements Under Section 1135 of the Social Security Act. Public 
Health Emergency. https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
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    On March 27, 2020, we sent a guidance memorandum under the subject 
title, ``Exceptions and Extensions for Quality Reporting Requirements 
for Acute Care Hospitals, PPS-Exempt Cancer Hospitals, Inpatient 
Psychiatric Facilities, Skilled Nursing Facilities, Home Health 
Agencies (HHAs), Hospices, Inpatient Rehabilitation Facilities, Long-
Term Care Hospitals, Ambulatory Surgical Centers, Renal Dialysis 
Facilities, and MIPS Eligible Clinicians Affected by COVID-19'' to the 
MLN Connects Newsletter and Other Program-Specific Listserv 
Recipients,\58\ hereafter referred to as the March 27, 2020 CMS 
Guidance Memorandum. In the March 27, 2020 CMS Guidance Memo, we 
granted an exception to the HH QRP reporting requirements under the HH 
QRP exceptions and extension requirements for Quarter 4 (Q4) 2019 
(October 1, 2019 through December 31, 2019), Q1 2020 (January 1, 2020 
through March 30, 2020), and Q2 2020 (April 1, 2020 through June 30, 
2020). The HH QRP exception applied to the HH QRP Outcome and 
Assessment Information Set (OASIS)-based measures, claims-based 
measures, and HH CAHPS Survey. We discuss the impact to the OASIS and 
claims here, and discuss to the HH CAHPS further in section III.G. 4, 
Update on Use of Q4 2019 HH QRP Data and Data Freeze for Refreshes in 
2021. For the OASIS, the exempted quarters are based upon admission and 
discharge assessments.
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    \58\ (2020, March 27). 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. Centers for Medicare & Medicaid Services. https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
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    A subset of the HH QRP measures has been publicly displayed on Home 
Health Compare (HH Compare) since 2003. Under the current HH QRP public 
display policy, Home Health Compare uses 4 quarters of data to publicly 
display OASIS-based measures, and 4 or more quarters of data to 
publicly display claims-based measures. We use four rolling quarters of 
data to publicly display Home Health Care Consumer Assessment of 
Healthcare Providers and Systems (HHCAHPS) Survey measures on Care 
Compare. As of September 2020, HH QRP OASIS, claims-based, and HHCAHPS 
Survey measures are reported on the www.medicare.gov's Care Compare 
website. As of December 2020, the data is no longer reported on the 
www.medicare.gov's Home Health Compare website.
    The exception granted under the March 27, 2020 CMS Guidance Memo 
impacted the HH QRP public display schedule. We will resume publicly 
displaying HH QRP claims-based measures in January 2022 based upon the 
quarters of data specified for each of the claims-based measures. Table 
30 displays the original schedule for public reporting of OASIS and 
HHCAHPS Survey measures prior to the Q1 and Q2 2020 data impacted by 
the COVID-19 PHE.
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    During the spring and summer of 2020, we conducted testing to 
inform decisions about publicly displaying HH QRP data for those 
refreshes which include data from the exception period of October 1, 
2019 through June 30, 2020 (hereafter ``excepted data''). The testing 
helped us develop a plan for displaying HH QRP data that are as up-to-
date as possible and that also meet scientifically-acceptable standards 
for publicly displaying those data. We believe that the plan allows us 
to provide consumers with helpful information on the quality of home 
health care, while also making the necessary adjustments to accommodate 
the exception granted to HHAs. The following sections provide the 
results of our testing for OASIS and claims and explain how we used the 
results to inform a proposal for accommodating excepted data in public 
reporting. HH CAHPS discussion is further in section III.G.4.
4. Update on Use of Q4 2019 HH QRP Data and Data Freeze for Refreshes 
in 2021
    In the March 27, 2020 Guidance Memorandum, we stated that we should 
not include any PAC quality data that are greatly impacted by the 
exception granted in the quality reporting programs. Given the timing 
of the PHE onset, we determined that we would not use HH QRP OASIS, 
claims, or HHCAHPS data from Q1 and Q2 of 2020 for public reporting, 
and that we would assess the impact of the COVID-19 PHE on HH QRP data 
from Q4 2019. In the original schedule (Table 30), the October 2020 
refresh included Q4 2019 measure based on OASIS and HHCAHPS data and is 
the last refresh before Q1 2020 data are included.
    Before proceeding with the October 2020 refresh, we conducted 
testing to ensure that publicly displaying Q4 2019 data would still 
meet our standards despite granting an exception to HH QRP reporting 
requirements for Q4 2019. Specifically, we compared submission rates in 
Q4 2019 to average rates in other quarters to assess the extent to 
which HHAs had taken advantage of the exemption, and thus the extent to 
which data and measure scores might be affected. We observed that the 
quality data submission rate for Q4 2019 was in fact 0.4 percent higher 
than the previous calendar year (Q4 2018). We note that Q4 2019 ended 
before the onset of the COVID-19 pandemic in the U.S. Thus, we 
proceeded with including Q4 2019 data in measure calculations for the 
October 2020 refresh.
    Because we excepted HHAs from the HH QRP reporting requirements for 
Q1 and Q2 2020, we did not use OASIS, claims, or HHCAHPS data from 
these quarters. All refreshes, during which we decided to hold this 
data constant, included more than 2 quarters of data that were affected 
by the CMS-issued COVID reporting exceptions, thus we did not have an 
adequate amount of data to reliably calculate and publicly display 
provider measures scores.
    Consequently, we determined to freeze the data displayed, that is, 
holding data constant after the October 2020 refresh without 
subsequently updating the data through October 2021. We communicated 
this in a Public Reporting Tip Sheet, which is located at: https://www.cms.gov/files/document/hhqrp-pr-tip-sheet081320final-cx-508.pdf.
5. Proposal To Use the COVID-19 PHE Affected Reporting (CAR) Scenario 
To Publicly Display Certain HH QRP Measures (Beginning in January 2022 
through July 2024) Due to the COVID-19 PHE
    We are also proposing to use the CAR scenario for refreshes for 
January 2022 for OASIS and for refreshes from January 2022 through July 
2024 for some claims-based measures. There are several forthcoming HH 
QRP refreshes

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for which the original public reporting schedule included other 
quarters from the quality data submission exception. These refreshes 
for claims-based measures, OASIS-based measures, and for HHCAHPS Survey 
measures are outlined above (Table 30).
    Because October 2020 refresh data will become increasingly out-of-
date and thus less useful for the public, we analyzed whether it would 
be possible to use fewer quarters of data for one or more refreshes and 
thus reduce the number of refreshes that continue to display October 
2020 data. Using fewer quarters of more up-to-date data requires that: 
(1) A sufficient percentage of HHAs would still likely have enough 
OASIS data to report quality measures (reportability); and (2) using 
fewer quarters of data to calculate measures would likely produce 
similar measure scores for HHAs, and thus not unfairly represent the 
quality of care HHAs provided during the period reported in a given 
refresh (reliability).
    To assess these criteria, we conducted reportability and 
reliability analysis excluding the COVID-19 affected quarters of data 
in a refresh instead of the standard number of quarters of data for 
reporting for each HH QRP measure to model the impact of not using Q1 
or Q2 2020. Specifically, we used historical data to calculate HH 
quality measures under two scenarios:
     Standard Public Reporting (SPR) Scenario: We used HH QRP 
data from CY 2017 through 2019 to build the standard reported measures, 
to represent as a proxy CY 2020 public reporting in the absence of the 
temporary exemptions from the submission of OASIS quality data, as the 
basis for comparing simulated alternatives. This entails using 4 
quarters of CY 2019 HH QRP data to model the OASIS based measures that 
are normally calculated using 4 quarters of data. This also entailed 
using 4 quarters of HH QRP data from CY 2019 for the all-cause 
hospitalization and emergency department use claims-based measures, 8 
quarters of HH QRP data from CY2018 and CY2019 for Medicare spending 
per beneficiary (MSPB) and discharge to community (DTC) claims-based 
measures; and or 12 quarters from January 2017 to December 2019 for the 
potentially preventable readmission claims-based measure.
     COVID-19 Affected Reporting (CAR) Scenario: We calculated 
OASIS-based measures using 3 quarters of HH QRP CY 2019 data to 
simulate using only Q3 2020, Q4 2020, and Q1 2021 data for public 
reporting. We calculated claims-based measures using HH QRP CY 2017 to 
2019 data, to simulate using the most recent data while excluding the 
same quarters (Q1 and Q2) that are relevant from the PHE exception. We 
used 3 quarters of HH QRP data from CY 2019 for the all-cause 
hospitalization and emergency department use claims-based measures and 
6 quarters of data from HH QRP CY 2018 and CY 2019 were used for both 
the Medicare spending per beneficiary and discharge to community 
claims-based measures. We used 10 quarters of HH QRP data from CY 2017 
to 2019 to calculate the CAR scenario for the potentially preventable 
readmissions claims-based measure. For both claims and OASIS-based 
measures, the quarters used in our analysis were the most recently 
available data that exclude the same quarters (Q1 and Q2) as that are 
relevant from the PHE exception, and thus take seasonality into 
consideration.
    The OASIS-based measures are based on the start of care and 
calculated using admission dates. Therefore, under the CAR scenario we 
excluded data for OASIS-based measures for HHA patient stays with 
admission dates in Q1 and Q2 2019. To assess performance in these 
scenarios, we calculated the reportability as the percent of HHAs 
meeting the 20-case minimum for public reporting (the public reporting 
threshold, or ``PRT''). We evaluated measure reliability using the 
Pearson and Spearman correlation coefficients, which assess the 
alignment of HHs measure scores between scenarios. To calculate the 
reliability results, we restricted the HHAs included in the SPR 
Scenario to those included in the CAR Scenario.
    Testing results showed that using the CAR scenario would achieve 
scientifically acceptable quality measure scores for the HH QRP. As 
displayed in Table 31, the percentage of HHAs that met the public 
display threshold for the OASIS-based measure decreases by 5.5 
percentage points or less for all but one QM, the Influenza 
Immunization for the Current Flu Season in the CAR scenario versus SPR 
scenario. CMS has traditionally used a reportability threshold of 70 
percent, meaning at least 70 percent of HHAs are able to report at 
least 20 episodes for a given measure, as the standard to determine 
whether a measure should be publicly reported. By this standard, we 
consider a decrease of 5.5 percentage points or less scientifically 
acceptable. The change in reportability for the Influenza Immunization 
for the Current Flu Season measure is related to the seasonality of 
this measure, which includes cases that occur during the flu season 
only.
    Under the CAR scenario, the January 2022 refresh data would cover 
Q3 and Q4 of 2020 and Q1 of 2021, which occur during the flu season. 
This simulation included Q2 through Q4 of 2019, which crosses the flu 
season. Thus, the reportability of the actual data used is likely to be 
better than this simulation. Therefore, in general, using CAR scenario 
for the OASIS and claims-based measures would achieve acceptable 
reportability for the HH QRP measures. Testing also yielded correlation 
coefficients above 0.85, indicating a high degree of agreement between 
HH measure scores when using the CAR scenario or the SPR scenario.
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    We are proposing to use the CAR scenario for the last of the 
refreshes affecting OASIS-based measures, which will occur in January 
2022. We are also proposing to use the CAR scenario for refreshes from 
January 2022 through July 2024 for some claims-based measures.
    Our proposal of the CAR scenario for the January 2022 refresh would 
allow us to begin displaying recent data in January 2022, rather than 
continue displaying October 2020 data (Q1 2019

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through Q4 2019). We believe that updating the data in January 2022 by 
more than a year relative to the October 2020 freeze data can assist 
the public by providing more relevant quality data and allow CMS to 
display more recent HHA performance. Similarly, using fewer than 
standard numbers of quarters for claims-based measures that typically 
use eight or twelve months of data for reporting between January 2022 
and July 2024 will allow us to begin providing more relevant data 
sooner. Our testing results indicate we can achieve these positive 
impacts while maintaining high standards for reportability and 
reliability. Table 32 and Table 33 summarize the comparison between the 
original schedule for public reporting with the revised schedule (that 
is, frozen data) and also with the proposed public display schedule 
under the CAR scenario (that is, using 3 quarters in the January 2022 
refresh), for OASIS- and claims-based measures respectively.
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    We are soliciting public comments on the proposal to use the CAR 
scenario to publicly report HH OASIS in January 2022 and claims-based 
measures beginning with the January 2022 through July 2024 refreshes.
6. Update to the Public Display of HHCAHPS Measures Due to the COVID-19 
PHE Exception
    Since April 2012, we have publicly displayed four quarters of 
HHCAHPS data every quarter, in the months of January, April, July, and 
October. The COVID-19 PHE Exception applied to Q1 and Q2 of 2020. Those 
excepted quarters cannot be publicly displayed and resulted in the 
freezing of the public display using Q1 2019 through Q4 2019 data for 
the refreshes that would have occurred from October 2020 through 
October 2021, as shown in Table 34. Beginning with January 2022, we 
will resume reporting four quarters of HHCAHPS data. The data for the 
January 2022 refresh are Q3 2020 through Q2 2021. These are the same 
quarters that would have been publicly

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displayed despite the COVID-19 PHE. Table 34 summarizes this 
discussion.
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IV. Requests for Information

A. Fast Healthcare Interoperability Resources (FHIR) in Support of 
Digital Quality Measurement in Post-Acute Care Quality Reporting 
Programs--Request for Information

1. Background
    A goal of the HQRP is to improve the quality of health care for 
beneficiaries through measurement, transparency, and public reporting 
of data. The HQRP contributes to improvements in health care, enhancing 
patient outcomes, and informing consumer choice. In October 2017, we 
launched the Meaningful Measures Framework. This framework captures our 
vision to address health care quality priorities and gaps, including 
emphasizing digital quality measurement (dQM), reducing measurement 
burden, and promoting patient perspectives, while also focusing on 
modernization and innovation. The scope of the Meaningful Measures 
Framework has evolved to Meaningful Measure 2.0 to accommodate the 
changes in the health care environment, initially focusing on measure 
and burden reduction to include the promotion of innovation and 
modernization of all aspects of quality.\59\ There is a need to 
streamline our approach to data collection, calculation, and reporting 
to fully leverage clinical and patient-centered information for 
measurement, improvement, and learning.
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    \59\ Meaningful Measures 2.0: Moving from Measure Reduction to 
Modernization. Available at: https://www.cms.gov/meaningful-measures-20-moving-measure-reduction-modernization.
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    In alignment with the Meaningful Measure 2.0, we are seeking 
feedback on our future plans to define digital quality measures for the 
HQRP. We also are seeking feedback on the potential use of Fast 
Healthcare Interoperable Resources (FHIR) for dQMs within the HQRP 
aligning where possible with other quality programs. FHIR is an open 
source standards framework (in both commercial and government settings) 
created by Health Level Seven International (HL7[supreg]) that 
establishes a common language and process for all health information 
technology.
2. Definition of Digital Quality Measures
    We are considering adopting a standardized definition of Digital 
Quality Measures (dQMs) in alignment across QRPs. We are considering in 
the future to propose the adoption within the HQRP the following 
definition: Digital Quality Measures (dQMs) are quality measures that 
use one or more sources of health information that are captured and can 
be transmitted electronically via interoperable

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systems.\60\ A dQM includes software that processes digital data to 
produce a measure score or measure scores. Data sources for dQMs may 
include administrative systems, electronically submitted clinical 
assessment data, case management systems, electronic health records 
(EHRs), instruments (for example, medical devices and wearable 
devices), patient portals or applications (for example, for collection 
of patient-generated health data), health information exchanges (HIEs) 
or registries, and other sources. As an example, the quality measures 
calculated from patient assessment data submitted electronically to CMS 
would be considered digital quality measures.
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    \60\ Definition taken from the CMS Quality Conference 2021.
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3. Use of FHIR for Future dQMs in HQRP
    Over the past two years in other programs, we have focused on 
opportunities to streamline and modernize quality data collection and 
reporting processes, such as exploring HL7[supreg] FHIR[supreg] (http://hl7.org/fhir) for quality reporting programs. One of the first areas 
CMS has identified relative to improving our digital strategy is 
through the use of FHIR-based standards to exchange clinical 
information through application programming interfaces (APIs), allowing 
clinicians to digitally submit quality information one time that can 
then be used in many ways. We believe that in the future proposing such 
a standard within the HQRP could potentially enable collaboration and 
information sharing, which is essential for delivering high-quality 
care and better outcomes at a lower cost.
    We are currently evaluating the use of FHIR based APIs to access 
assessment data collected and maintained through the Quality 
Improvement and Evaluation System (QIES) and internet QIES (iQIES) 
health information systems and are working with healthcare standards 
organizations to assure that their evolving standards fully support our 
assessment instrument content. Further, as more hospice providers are 
adopting EHRs including hospices, we are evaluating using the FHIR 
interfaces for accessing patient data (including standard assessments) 
directly from hospice EHRs. Accessing data in this manner could also 
enable the exchange of data for purposes beyond data reporting to CMS, 
such as care coordination further increasing the value of EHR 
investments across the healthcare continuum. Once providers map their 
EHR data to a FHIR API in standard FHIR formats it could be possible to 
send and receive the data needed for measures and other uses from their 
EHRs through FHIR APIs.
4. Future Alignment of Measures Across Reporting Programs, Federal and 
State Agencies, and the Private Sector
    We are committed to using policy levers and working with 
stakeholders to achieve interoperable data exchange and to transition 
to full digital quality measurement in our quality programs. We are 
considering the future potential development and staged implementation 
of a cohesive portfolio of dQMs across our regulated programs, 
including HQRP, agencies, and private payers. This cohesive portfolio 
would require, where possible, alignment of: (1) Measure concepts and 
specifications including narrative statements, measure logic, and value 
sets, and (2) the individual data elements used to build these measure 
specifications and calculate the measures. Further, the required data 
elements would be limited to standardized, interoperable elements to 
the fullest extent possible; hence, part of the alignment strategy will 
be the consideration and advancement of data standards and 
implementation guides for key data elements. We would coordinate 
closely with quality measure developers, Federal and state agencies, 
and private payers to develop and to maintain a cohesive dQM portfolio 
that meets our programmatic requirements and that fully aligns across 
Federal and state agencies and payers to the extent possible.
    We intend this coordination to be ongoing and allow for continuous 
refinement to ensure quality measures remain aligned with evolving 
healthcare practices and priorities (for example, patient reported 
outcomes (PROs), disparities, care coordination), and track with the 
transformation of data collection. This includes conformance with 
standards and health IT module updates, future adoption of technologies 
incorporated within the ONC Health IT Certification Program and may 
also include standards adopted by ONC (for example, standards-based 
APIs). The coordination would build on the principles outlined in HHS' 
Nation Health Quality Roadmap.\61\
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    \61\ Department of Health and Human Services. National Health 
Quality Roadmap. May 15, 2020. Available at: https://www.hhs.gov/sites/default/files/national-health-quality-roadmap.pdf.
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    It would focus on the quality domains of safety, timeliness, 
efficiency, effectiveness, equitability, and patient-centeredness. It 
would leverage several existing Federal and public-private efforts 
including our Meaningful Measures 2.0 Framework; the Federal Electronic 
Health Record Modernization (DoD/VA); the Core Quality Measure 
Collaborative, which convenes stakeholders from America's Health 
Insurance Plans (AHIP), CMS, NQF, provider organizations, private 
payers, and consumers and develops consensus on quality measures for 
provider specialties; and the NQF-convened Measure Applications 
Partnership (MAP), which recommends measures for use in public payment 
and reporting programs. We would coordinate with HL7's ongoing work to 
advance FHIR resources in critical areas to support patient care and 
measurement such as social determinants of health. Through this 
coordination, we would identify which existing measures could be used 
or evolved to be used as dQMs, in recognition of current healthcare 
practice and priorities.
    This multi-stakeholder, joint Federal, state, and industry effort, 
made possible and enabled by the pending advances towards 
interoperability, would yield a significantly improved quality 
measurement enterprise. The success of the dQM portfolio would be 
enhanced by the degree to which the measures achieve our programmatic 
requirements as well as the requirements of other agencies and payers.
5. Solicitation of Comments
    We seek input on the following steps that would enable 
transformation of CMS' quality measurement enterprise to be fully 
digital:
    a. What EHR/IT systems do you use and do you participate in a 
health information exchange (HIE)?
    b. How do you currently share information with other providers and 
are there specific industry best practices for integrating SDOH 
screening into EHR's?
    c. What ways could we incentivize or reward innovative uses of 
health information technology (IT) that could reduce burden for post-
acute care settings, including but not limited to hospices?
    d. What additional resources or tools would post-acute care 
settings, including but not limited to hospices and health IT vendors 
find helpful to support testing, implementation, collection, and 
reporting of all measures using FHIR standards via secure APIs to 
reinforce the sharing of patient health information between care 
settings?
    e. Would vendors, including those that service post-acute care 
settings, including but not limited to hospices, be interested in or 
willing to participate in pilots or models of alternative approaches to 
quality measurement that

[[Page 19766]]

would align standards for quality measure data collection across care 
settings to improve care coordination, such as sharing patient data via 
secure FHIR API as the basis for calculating and reporting digital 
measures?
    f. What could be the potential use of FHIR dQMs that could be 
adopted across all QRPs?
    We plan to continue working with other agencies and stakeholders to 
coordinate and to inform our transformation to dQMs leveraging health 
IT standards. While we will not be responding to specific comments 
submitted in response to this Request for Information in the FY 2022 
Hospice final rule, we will actively consider all input as we develop 
future regulatory proposals or future sub-regulatory policy guidance. 
Any updates to specific program requirements related to quality 
measurement and reporting provisions would be addressed through 
separate and future notice- and-comment rulemaking, as necessary.

B. Closing the Health Equity Gap in Post-Acute Care Quality Reporting 
Programs--Request for Information

1. Background
    Significant and persistent inequities in health outcomes exist in 
the United States. In recognition of persistent health disparities and 
the importance of closing the health equity gap, we request information 
on expanding several related CMS programs to make reporting of health 
disparities based on social risk factors and race and ethnicity more 
comprehensive and actionable for providers and patients. Belonging to a 
racial or ethnic minority group; living with a disability; being a 
member of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) 
community; or being near or below the poverty level, is often 
associated with worse health 
outcomes.62 63 64 65 66 67 68 69 Such disparities in health 
outcomes are the result of number of factors, but importantly for CMS 
programs, although not the sole determinant, poor access and provision 
of lower quality health care contribute to health disparities. For 
instance, numerous studies have shown that among Medicare 
beneficiaries, racial and ethnic minority individuals often receive 
lower quality of care, report lower experiences of care, and experience 
more frequent hospital readmissions and operative 
complications.70 71 72 73 74 75 Readmission rates for common 
conditions in the Hospital Readmissions Reduction Program are higher 
for black Medicare beneficiaries and higher for Hispanic Medicare 
beneficiaries with Congestive Heart Failure and Acute Myocardial 
Infarction.76 77 78 79 80 Studies have also shown that 
African Americans are significantly more likely than white Americans to 
die prematurely from heart disease and stroke.\81\ The COVID-19 
pandemic has further illustrated many of these longstanding health 
inequities with higher rates of infection, hospitalization, and 
mortality among black, Latino, and Indigenous and Native American 
persons relative to white persons.82 83 As noted by the 
Centers for Disease Control ``long-standing systemic health and social 
inequities have put many people from racial and ethnic minority groups 
at increased risk of getting sick and dying from COVID-19''.\84\ One 
important strategy for addressing these important inequities is by 
improving data collection to allow for better measurement and reporting 
on equity across our programs and policies.
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    \62\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for 
Medicare Beneficiaries by Race and Site of Care. JAMA. 2011; 
305(7):675-681.
    \63\ Lindenauer PK, Lagu T, Rothberg MB, et al. Income 
Inequality and 30 Day Outcomes After Acute Myocardial Infarction, 
Heart Failure, and Pneumonia: Retrospective Cohort Study. British 
Medical Journal. 2013; 346.
    \64\ Trivedi AN, Nsa W, Hausmann LRM, et al. Quality and Equity 
of Care in U.S. Hospitals. New England Journal of Medicine. 2014; 
371(24):2298-2308.
    \65\ Polyakova, M., et al. Racial Disparities In Excess All-
Cause Mortality During The Early COVID-19 Pandemic Varied 
Substantially Across States. Health Affairs. 2021; 40(2): 307-316.
    \66\ Rural Health Research Gateway. Rural Communities: Age, 
Income, and Health Status. Rural Health Research Recap. November 
2018.
    \67\ https://www.minorityhealth.hhs.gov/assets/PDF/Update_HHS_Disparities_Dept-FY2020.pdf.
    \68\ www.cdc.gov/mmwr/volumes/70/wr/mm7005a1.htm.
    \69\ Poteat TC, Reisner SL, Miller M, Wirtz AL. COVID-19 
Vulnerability of Transgender Women With and Without HIV Infection in 
the Eastern and Southern U.S. Preprint. medRxiv. 
2020;2020.07.21.20159327. Published 2020 Jul 24. doi:10.1101/
2020.07.21.20159327.
    \70\ Martino, SC, Elliott, MN, Dembosky, JW, Hambarsoomian, K, 
Burkhart, Q, Klein, DJ, Gildner, J, and Haviland, AM. Racial, 
Ethnic, and Gender Disparities in Health Care in Medicare Advantage. 
Baltimore, MD: CMS Office of Minority Health. 2020.
    \71\ Guide to Reducing Disparities in Readmissions. CMS Office 
of Minority Health. Revised August 2018. Available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
    \72\ Singh JA, Lu X, Rosenthal GE, Ibrahim S, Cram P. Racial 
disparities in knee and hip total joint arthroplasty: An 18-year 
analysis of national Medicare data. Ann Rheum Dis. 2014 
Dec;73(12):2107-15.
    \73\ Rivera-Hernandez M, Rahman M, Mor V, Trivedi AN. Racial 
Disparities in Readmission Rates among Patients Discharged to 
Skilled Nursing Facilities. J Am Geriatr Soc. 2019 Aug;67(8):1672-
1679.
    \74\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for 
Medicare Beneficiaries by Race and Site of Care. JAMA. 
2011;305(7):675-681.
    \75\ Tsai TC, Orav EJ, Joynt KE. Disparities in surgical 30-day 
readmission rates for Medicare beneficiaries by race and site of 
care. Ann Surg. Jun 2014;259(6):1086-1090.
    \76\ Rodriguez F, Joynt KE, Lopez L, Saldana F, Jha AK. 
Readmission rates for Hispanic Medicare beneficiaries with heart 
failure and acute myocardial infarction. Am Heart J. Aug 
2011;162(2):254-261 e253.
    \77\ Centers for Medicare and Medicaid Services. Medicare 
Hospital Quality Chartbook: Performance Report on Outcome Measures; 
2014.
    \78\ Guide to Reducing Disparities in Readmissions. CMS Office 
of Minority Health. Revised August 2018. Available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
    \79\ Prieto-Centurion V, Gussin HA, Rolle AJ, Krishnan JA. 
Chronic obstructive pulmonary disease readmissions at minority-
serving institutions. Ann Am Thorac Soc. Dec 2013;10(6):680-684.
    \80\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for 
Medicare Beneficiaries by Race and Site of Care. JAMA. 
2011;305(7):675-681.
    \81\ HHS. Heart disease and African Americans. (March 29, 2021). 
https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
    \82\ https://www.cms.gov/files/document/medicare-covid-19-data-snapshot-fact-sheet.pdf.
    \83\ Ochieng N, Cubanski J, Neuman T, Artiga S, and Damico A. 
Racial and Ethnic Health Inequities and Medicare. Kaiser Family 
Foundation. Februray 2021. Available at: https://www.kff.org/medicare/report/racial-and-ethnic-health-inequities-and-medicare/.
    \84\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html.
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    We are committed to achieving equity in health care outcomes for 
our beneficiaries by supporting providers in quality improvement 
activities to reduce health inequities, enabling beneficiaries to make 
more informed decisions, and promoting provider accountability for 
health care disparities.85 86 For the purposes of this rule, 
we are using a definition of equity established in Executive Order 
13985, as ``the consistent and systematic fair, just, and impartial 
treatment of all individuals, including individuals who belong to 
underserved communities that have been denied such treatment, such as 
Black, Latino, and Indigenous and Native American persons, Asian 
Americans and Pacific Islanders and other persons of color; members of 
religious minorities; lesbian, gay, bisexual, transgender, and queer 
(LGBTQ+) persons; persons with disabilities; persons who live in rural 
areas; and persons otherwise adversely

[[Page 19767]]

affected by persistent poverty or inequality.'' \87\ We note that this 
definition was recently established by the current administration, and 
provides a useful, common definition for equity across different areas 
of government, although numerous other definitions of equity exist.
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    \85\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
    \86\ Report to Congress: Improving Medicare Post-Acute Care 
Transformation (IMPACT) Act of 2014 Strategic Plan for Accessing 
Race and Ethnicity Data. January 5, 2017. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Research-Reports-2017-Report-to-Congress-IMPACT-ACT-of-2014.pdf.
    \87\ https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-Federal-government.
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    Our ongoing commitment to closing the equity gap in CMS quality 
programs is demonstrated by a portfolio of programs aimed at making 
information on the quality of health care providers and services, 
including disparities, more transparent to consumers and providers. The 
CMS Equity Plan for Improving Quality in Medicare aims to support 
Quality Improvement Networks and Quality Improvement Organizations 
(QIN-QIOs); Federal, state, local, and tribal organizations; providers; 
researchers; policymakers; beneficiaries and their families; and other 
stakeholders in activities to achieve health equity. The CMS Equity 
Plan includes three core elements: (1) Increasing understanding and 
awareness of disparities; (2) developing and disseminating solutions to 
achieve health equity; and (3) implementing sustainable actions to 
achieve health equity.\88\ The CMS Quality Strategy and Meaningful 
Measures Framework \89\ include elimination of racial and ethnic 
disparities as a fundamental principle. Our ongoing commitment to 
closing the health equity gap in the HQRP is demonstrated by the 
sharing of information from the Medicare PAC PUF on Care Compare and 
seeking to adopt through future rulemaking aspects of the standardized 
patient assessment data elements (SPADEs) that apply to hospice which 
include several social determinants of health (SDOH).
---------------------------------------------------------------------------

    \88\ Centers for Medicare & Medicaid Services Office of Minority 
Health. The CMS Equity Plan for Improving Quality in Medicare. 
https://www.cms.gov/About-CMS/Agency-Information/OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_090615.pdf.
    \89\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.
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    We continue to work with Federal and private partners to better 
collect and leverage data on social risk to improve our understanding 
of how these factors can be better measured in order to close the 
health equity gap. Among other things, we have developed an Inventory 
of Resources for Standardized Demographic and Language Data Collection 
\90\ and supported collection of specialized International 
Classification of Disease, 10th Edition, Clinical Modification (ICD-10-
CM) codes for describing the socioeconomic, cultural, and environmental 
determinants of health. We continue to work to improve our 
understanding of this important issue and to identify policy solutions 
that achieve the goals of attaining health equity for all patients.
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    \90\ Centers for Medicare and Medicaid Services. Building an 
Organizational Response to Health Disparities Inventory of Resources 
for Standardized Demographic and Language Data Collection. 2020. 
https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Collection-Resources.pdf.
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2. Solicitation of Public Comment
    While hospice is not included in the Improving Medicare Post-Acute 
Care Transformation (IMPACT) Act of 2014 (Pub. L. 113-185), we look at 
measures adopted based on that Act, like SPADES and if aspects apply to 
hospice then we would consider including it in the HQRP. This helps 
with continuity of care since patients may transition from different 
PAC settings to hospice and it would address a gap in hospice care. We 
are seeking comment on the possibility of expanding measure 
development, and adding aspects of SPADEs that could apply to hospice 
and address gaps in health equity in the HQRP. Any potential health 
equity data collection or measure reporting within a CMS program that 
might result from public comments received in response to this 
solicitation would be addressed through a separate notice- and-comment 
rulemaking in the future.
    Specifically, we are inviting public comment on the following:
     Recommendations for quality measures, or measurement 
domains that address health equity, for use in the HQRP.
     Suggested parts of SDOH SPADEs adoption that could apply 
to hospice in alignment with national data collection and interoperable 
exchange standards. This could include collecting information on 
certain SDOH, including race, ethnicity, preferred language, 
interpreter services, health literacy, transportation and social 
isolation. CMS is seeking guidance on any additional items, including 
SPADEs that could be used to assess health equity in the care of 
hospice patients, for use in the HQRP.
     Ways CMS can promote health equity in outcomes among 
hospice patients. We are also interested in feedback regarding whether 
including facility-level quality measure results stratified by social 
risk factors and social determinants of health (for example, dual 
eligibility for Medicare and Medicaid, race) in confidential feedback 
reports could allow facilities to identify gaps in the quality of care 
they provide. (For example, methods similar or analogous to the CMS 
Disparity Methods \91\ which provide hospital-level confidential 
results stratified by dual eligibility for condition-specific 
readmission measures currently included in the Hospital Readmission 
Reduction Program (84 FR 42496 through 42500)).
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    \91\ https://qualitynet.cms.gov/inpatient/measures/disparity-methods/methodology.
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     Methods that commenters or their organizations use in 
employing data to reduce disparities and improve patient outcomes, 
including the source(s) of data used, as appropriate.
     Given the importance of structured data and health IT 
standards for the capture, use, and exchange of relevant health data 
for improving health equity, the existing challenges providers' 
encounter for effective capture, use, and exchange of health 
information, such as data on race, ethnicity, and other social 
determinants of health, to support care delivery and decision making.
    While we will not be responding to specific comments submitted in 
response to this Request for Information in the FY 2022 Hospice Wage 
Index final rule, we intend to use this input to inform future policy 
development. We look forward to receiving feedback on these topics, and 
note for readers that responses to the RFI will not directly impact 
payment decisions. We also note our intention for an additional RFI or 
rulemaking on this topic in the future. We look forward to receiving 
feedback on these topics, and note for readers that responses to the 
RFI should focus on how they could be applied to the quality reporting 
program requirements.

V. Advancing Health Information Exchange

    The Department of Health and Human Services (HHS) has a number of 
initiatives designed to encourage and support the adoption of 
interoperable health information technology and to promote nationwide 
health information exchange to improve health care and patient access 
to their health information. To further interoperability in post-acute 
care settings, the Centers for Medicare & Medicaid Services (CMS) and 
the Office of the National Coordinator for Health Information 
Technology (ONC) participate in the Post-Acute Care Interoperability 
Workgroup (PACIO) (https://pacioproject.org/) to facilitate 
collaboration with industry stakeholders to develop Fast Healthcare 
Interoperability Resources (FHIR)

[[Page 19768]]

standards. These standards could support the exchange and reuse of 
patient assessment data derived from the minimum data set (MDS), 
inpatient rehabilitation facility patient assessment instrument (IRF-
PAI), long term care hospital continuity assessment record and 
evaluation (LCDS), outcome and assessment information set (OASIS), and 
other sources, including HOPE if implemented in HQRP through future 
rulemaking. The PACIO Project has focused on FHIR implementation guides 
for functional status, cognitive status and new use cases on advance 
directives and speech, and language pathology. We encourage PAC 
provider and health IT vendor participation as these efforts advance.
    The CMS Data Element Library (DEL) continues to be updated and 
serves as the authoritative resource for PAC assessment data elements 
and their associated mappings to health IT standards such as Logical 
Observation Identifiers Names and Codes and Systematized Nomenclature 
of Medicine. The DEL furthers CMS' goal of data standardization and 
interoperability. These interoperable data elements can reduce provider 
burden by allowing the use and exchange of healthcare data; supporting 
provider exchange of electronic health information for care 
coordination, person-centered care; and supporting real-time, data 
driven, clinical decision making. Standards in the Data Element Library 
(https://del.cms.gov/DELWeb/pubHome) can be referenced on the CMS 
website and in the ONC Interoperability Standards Advisory (ISA). The 
2021 ISA is available at https://www.healthit.gov/isa.
    The 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted 
December 13, 2016) requires HHS to take new steps to enable the 
electronic sharing of health information ensuring interoperability for 
providers and settings across the care continuum. The Cures Act 
includes a trusted exchange framework and common agreement (TEFCA) 
provision \92\ that will enable the nationwide exchange of electronic 
health information across health information networks and provide an 
important way to enable bi-directional health information exchange in 
the future. For more information on current developments related to 
TEFCA, we refer readers to https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement and 
https://rce.sequoiaproject.org/.
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    \92\ ONC, Draft 2 Trusted Exchange Framework and Common 
Agreement, https://www.healthit.gov/sites/default/files/page/2019-04/FINALTEFCAQTF41719508version.pdf.
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    On May 1, 2020, ONC published a final rule in the Federal Register 
entitled ``21st Century Cures Act: Interoperability, Information 
Blocking, and the ONC Health IT Certification Program'' (85 FR 25642) 
that established policies related to information blocking as authorized 
under section 4004 of the 21st Century Cures Act. Information blocking 
is generally defined as a practice by a health IT developer of 
certified health IT, health information network, health information 
exchange, or health care provider that, except as required by law or 
specified by the Secretary of HHS as a reasonable and necessary 
activity, is likely to interfere with access, exchange, or use of 
electronic health information. The definition of information blocking 
includes a knowledge standard, which is different for health care 
providers than for health IT developers of certified health IT and 
health information networks or health information exchanges. A 
healthcare provider must know that the practice is unreasonable as well 
as likely to interfere with access, exchange, or use of electronic 
health information. To deter information blocking, health IT developers 
of certified health IT, health information networks and health 
information exchanges whom the HHS Inspector General determines, 
following an investigation, have committed information blocking, are 
subject to civil monetary penalties of up to $1 million per violation. 
Appropriate disincentives for health care providers are expected to be 
established by the Secretary through future rulemaking. Stakeholders 
can learn more about information blocking at https://www.healthit.gov/curesrule/final-rule-policy/information-blocking. ONC has posted 
information resources including fact sheets (https://www.healthit.gov/curesrule/resources/fact-sheets), frequently asked questions (https://www.healthit.gov/curesrule/resources/information-blocking-faqs), and 
recorded webinars (https://www.healthit.gov/curesrule/resources/webinars).
    We invite providers to learn more about these important 
developments and how they could affect hospices.

VI. Collection of Information Requirements

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

A. ICRs Regarding Hospice QRP

    The HQRP proposals would not change provider burden or costs.
     For the proposal to remove the 7 HIS measures from the 
HQRP, we do not propose any changes to the requirement to submit the 
HIS admission assessment since we continue to collect the data for 
these 7 HIS measures in order to calculate the more broadly applicable 
NQF # 3235, the Hospice and Palliative Care Composite Process Measure--
HIS-Comprehensive Assessment Measure at Admission.
     The proposal to add the HCI also would not change provider 
burden or costs since it is a claims-based measure that CMS calculates 
from the Medicare claims data.
     Likewise, the proposal to publicly report the claims-based 
HVLDL quality measure would not result in reduced provider burden and 
related costs. The reduction in provider burden and costs occurred when 
we replaced the HIS-based HVWDII quality measure via the HIS-PRA 
package that OMB approved on February 16, 2021 (OMB Control Number: 
0938-1153, CMS-10390).
     Finally, the Home Health Rider proposal would not change 
provider burden or costs since it only affects the number of quarters 
used in the calculation of certain claims-based measures for the public 
display for certain refresh cycles.

B. ICRs Regarding Hospice CoPs

    We are proposing to revise the provisions at Sec.  418.76(c)(1) 
that requires the hospice aide to be evaluated by observing an aide's 
performance of the task with a patient. This proposed revision is 
subject to the PRA; however, the information collection burden 
associated with the existing requirements at Sec.  418.76(c)(1) are

[[Page 19769]]

accounted for under the information collection request currently 
approved OMB control number 0938-1067. The proposed revision's addition 
of the use of a ``pseudo patient'' allow for greater flexibility and 
may minimally reduce burden on the hospice. We request public comment 
on our determination that the time and effort necessary to comply with 
implementing the use of the pseudo-patient for hospice aide training at 
Sec.  418.76(c)(1), may reduce burden on the provider.
    We are also proposing to revise the provisions at Sec.  
418.76(h)(1)(iii) to state that if an area of concern is verified by 
the hospice during the on-site visit, then the hospice must conduct, 
and the hospice aide must complete, a competency evaluation related to 
the deficient and related skill(s) in accordance with Sec.  418.76(c). 
We believe this could increase the speed with which hospices perform 
competency testing and could allow new aides to begin serving patients 
more quickly as these proposed changes will allow the hospice to focus 
on specific aide skills when a skill deficiency is assessed. In 
accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2), we believe that both the existing requirements and the 
proposed revisions to the requirements at Sec.  418.76(h) are exempt 
from the PRA. We believe competency evaluations are a usual and 
customary business practice and we state as such in the information 
collection request associated with the Hospice Conditions of 
Participation (0938-1067). Therefore, we are not proposing to seek PRA 
approval for any information collection or recordkeeping activities 
that may be conducted in connection with the proposed revisions to 
Sec.  418.76(h), but we request public comment on our determination 
that the time and effort necessary to comply with these evaluation 
requirements is usual and customary, and would be incurred by hospice 
staff even absent this regulatory requirement.

C. Submission of PRA-Related Comments

    We have submitted a copy of this proposed rule to OMB for its 
review of the rule's information collection and recordkeeping 
requirements. The requirements are not effective until they have been 
approved by OMB.
    We invite public comments on these information collection 
requirements. If you wish to comment, please identify the rule (CMS-
1754-P) and, where applicable, the preamble section, and the ICR 
section. See this rule's DATES and ADDRESSES sections for the comment 
due date and for additional instructions and OMB control number 0938-
1153 (CMS-10390) or OMB control number 0938-1067 (CMS-10277).

VII. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

VIII. Regulatory Impact Analysis

A. Statement of Need

    This proposed rule meets the requirements of our regulations at 
Sec.  418.306(c) and (d), which require annual issuance, in the Federal 
Register, of the hospice wage index based on the most current available 
CMS hospital wage data, including any changes to the definitions of 
CBSAs or previously used MSAs, as well as any changes to the 
methodology for determining the per diem payment rates. This proposed 
rule would also update payment rates for each of the categories of 
hospice care, described in Sec.  418.302(b), for FY 2022 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.

B. Overall Impacts

    We estimate that the aggregate impact of the payment provisions in 
this proposed rule would result in an estimated increase of $530 
million in payments to hospices, resulting from the hospice payment 
update percentage of 2.3 percent for FY 2022. The impact analysis of 
this proposed rule represents the projected effects of the changes in 
hospice payments from FY 2021 to FY 2022. Using the most recent 
complete data available at the time of rulemaking, in this case FY 2020 
hospice claims data as of January 15, 2021, we apply the current FY 
2021 wage index with the current labor shares. Using the same FY 2020 
data, we apply the FY 2022 wage index and the current labor share 
values to simulate FY 2022 payments. We then apply a budget neutrality 
adjustment so that the aggregate simulated payments do not increase or 
decrease due to changes in the wage index. Then, using the same FY 2020 
data, we apply the FY 2022 wage index and the current labor share 
values to simulate FY 2022 payments and compare simulated payments 
using the FY 2022 wage index and the proposed revised labor shares. We 
then apply a budget neutrality adjustment so that the aggregate 
simulated payments do not increase or decrease due to changes in the 
labor share values.
    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 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999), and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with

[[Page 19770]]

economically significant effects ($100 million or more in any 1 year). 
We estimate that this rulemaking is ``economically significant'' as 
measured by the $100 million threshold, and hence also a major rule 
under the Congressional Review Act. Accordingly, we have prepared a RIA 
that, to the best of our ability presents the costs and benefits of the 
rulemaking.

C. Anticipated Effects

    The RFA requires agencies to analyze options for regulatory relief 
of small businesses if a rule has a significant impact on a substantial 
number of small entities. The great majority of hospitals and most 
other health care providers and suppliers are small entities by meeting 
the Small Business Administration (SBA) definition of a small business 
(in the service sector, having revenues of less than $8.0 million to 
$41.5 million in any 1 year), or being nonprofit organizations. For 
purposes of the RFA, we consider all hospices as small entities as that 
term is used in the RFA. The Department of Health and Human Services 
practice in interpreting the RFA is to consider effects economically 
``significant'' only if greater than 5 percent of providers reach a 
threshold of 3 to 5 percent or more of total revenue or total costs. 
The effect of the FY 2022 hospice payment update percentage results in 
an overall increase in estimated hospice payments of 2.3 percent, or 
$530 million. The distributional effects of the proposed FY 2022 
hospice wage index do not result in a greater than 5 percent of 
hospices experiencing decreases in payments of 3 percent or more of 
total revenue. Therefore, the Secretary has determined that this rule 
will not create a significant economic impact on a substantial number 
of small entities. In addition, section 1102(b) of the Act requires us 
to prepare a regulatory impact analysis if a rule may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of 
section 603 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a MSA and has fewer than 100 beds. This rule will only affect hospices. 
Therefore, the Secretary has determined that this rule will not have a 
significant impact on the operations of a substantial number of small 
rural hospitals (see table 34).
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. The 2021 UMRA 
threshold is $158 million. This rule is not anticipated to have an 
effect on state, local, or tribal governments, in the aggregate, or on 
the private sector of $158 million or more.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on state 
and local governments, preempts state law, or otherwise has Federalism 
implications. We have reviewed this rule under these criteria of 
Executive Order 13132, and have determined that it will not impose 
substantial direct costs on state or local governments.
    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this proposed rule, we 
should estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review the rule, we assume that the total number of unique 
commenters on last year's proposed rule will be the number of reviewers 
of this proposed rule. We acknowledge that this assumption may 
understate or overstate the costs of reviewing this proposed rule. It 
is possible that not all commenters reviewed last year's rule in 
detail, and it is also possible that some reviewers chose not to 
comment on the proposed rule. For these reasons we thought that the 
number of past commenters would be a fair estimate of the number of 
reviewers of this proposed rule.
    Using the wage information from the Bureau of Labor Statistics 
(BLS) for medical and health service managers (Code 11-9111); we 
estimate that the cost of reviewing this rule is $114.24 per hour, 
including overhead and fringe benefits (https://www.bls.gov/oes/current/oes_nat.htm). This proposed rule consists of approximately 
55,000 words. Assuming an average reading speed of 250 words per 
minute, it would take approximately 1.83 hours for the staff to review 
half of it. For each hospice that reviews the rule, the estimated cost 
is $209.06 (1.83 hour x $114.24). Therefore, we estimate that the total 
cost of reviewing this regulation is $11,080.18 ($209.06 x 53 
reviewers).

D. Detailed Economic Analysis

1. Proposed Hospice Payment Update for FY 2022
    The FY 2022 hospice payment impacts appear in Table 34. 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 2022 updated wage index data. 
This represents the effect of moving from the FY 2021 hospice wage 
index to the FY 2022 hospice wage index. The fourth column shows the 
effect of the proposed rebased labor shares. The aggregate impact of 
the changes in column three and four is zero percent, due to the 
hospice wage index standardization factor and the labor share 
standardization factor. However, there are distributional effects of 
the FY 2022 hospice wage index. The fifth 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 2.3 
hospice payment update percentage is based on the 2.5 percent inpatient 
hospital market basket update, reduced by a 0.2 percentage point 
productivity adjustment. The sixth column shows the effect of all the 
proposed changes on FY 2022 hospice payments. It is projected aggregate 
payments would increase by 2.3 percent; assuming hospices do not change 
their billing practices. As illustrated in Table 35, the combined 
effects of all the proposals vary by specific types of providers and by 
location.
    In addition, we are providing a provider-specific impact analysis 
file, which is available on our website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Regulations-and-Notices.html. We note that simulated payments are based on 
utilization in FY 2020 as seen on Medicare hospice claims (accessed 
from the CCW in January of 2021) 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 35, the combined effects of all the 
proposals vary by specific types of providers and by location.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TP14AP21.045


[[Page 19772]]


[GRAPHIC] [TIFF OMITTED] TP14AP21.046

BILLING CODE 4120-01-C

E. Alternatives Considered

    For the FY 2022 Hospice Wage Index and Rate Update proposed rule, 
we considered alternatives to the calculations of the wage index 
standardization factor and the labor share standardization factor. 
Typically, the wage index standardization factor is calculated using 
the most recent, complete hospice claims data available at the time of 
rulemaking. However, due to the COVID-19 PHE, we looked at using FY 
2019 claims data to determine if there were significant differences 
between utilizing FY 2019 and FY 2020 claims data for the calculation 
of the wage index and labor share standardization factors. The wage 
index standardization factors and labor share standardization factors 
for each level of care calculated using the FY 2020 claims data that 
was available at the time of rulemaking did not show significant 
differences compared to those calculated using FY 2019 claims data. As 
such, the differences between using FY 2019 and FY 2020 claims data for 
rate-setting were minimal. Therefore, we will continue our practice of 
using the most recent, complete hospice claims data to available at the 
time of rulemaking to set payment rates.

F. Accounting Statement

    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 36, we have prepared an accounting statement showing 
the classification of the expenditures associated with the provisions 
of this proposed rule. Table 36 provides our best estimate of the 
possible changes in Medicare payments under the hospice benefit as a 
result of the policies in this proposed rule. This estimate is based on 
the data for 4,957 hospices in our impact analysis file, which was 
constructed using FY 2020 claims available in January 2021. All

[[Page 19773]]

expenditures are classified as transfers to hospices.
[GRAPHIC] [TIFF OMITTED] TP14AP21.047

G. Conclusion

    We estimate that aggregate payments to hospices in FY 2022 will 
increase by $530 million as a result of the market basket update, 
compared to payments in FY 2021. We estimate that in FY 2022, hospices 
in urban areas will experience, on average, 2.2 percent increase in 
estimated payments compared to FY 2021. While hospices in rural areas 
will experience, on average, 2.6 percent increase in estimated payments 
compared to FY 2021. Hospices providing services in the Outlying and 
South Atlantic regions would experience the largest estimated increases 
in payments of 4.4 percent and 2.9 percent, respectively. Hospices 
serving patients in areas in the New England and Middle Atlantic 
regions would experience, on average, the lowest estimated increase of 
1.4 percent in FY 2022 payments.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 418

    Health facilities, Hospice care, Medicare, Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth 
below.

PART 418--HOSPICE CARE

0
1. The authority citation for part 418 continues to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh.

0
2. Section 418.3 is amended by adding definitions for ``Pseudo-
patient'' and ``Simulation'' in alphabetical order to read as follows:


Sec.  418.3  Definitions.

* * * * *
    Pseudo-patient means a person trained to participate in a role-play 
situation, or a computer-based mannequin device. A pseudo-patient must 
be capable of responding to and interacting with the hospice aide 
trainee, and must demonstrate the general characteristics of the 
primary patient population served by the hospice in key areas such as 
age, frailty, functional status, cognitive status and care goals.
* * * * *
    Simulation means a training and assessment technique that mimics 
the reality of the homecare environment, including environmental 
distractions and constraints that evoke or replicate substantial 
aspects of the real world in a fully interactive fashion, in order to 
teach and assess proficiency in performing skills, and to promote 
decision making and critical thinking.
* * * * *
0
3. Section 418.24 is amended by:
0
a. Revising paragraphs (c) introductory text and (c)(9);
0
b. Adding paragraph (c)(10);
0
c. Redesignating paragraphs (d) through (g) as paragraphs (e) through 
(h); and
0
d. Adding a new paragraph (d).
    The revisions and additions read as follows:


Sec.  418.24  Election of hospice care.

* * * * *
    (c) Content of hospice election statement addendum. For hospice 
elections beginning on or after October 1, 2020, in the event that the 
hospice determines there are conditions, items, services, or drugs that 
are unrelated to the individual's terminal illness and related 
conditions, the individual (or representative), non-hospice providers 
furnishing such items, services, or drugs, or Medicare contractors may 
request a written list as an addendum to the election statement. The 
election statement addendum must include the following:
* * * * *
    (9) Name and signature of the individual (or representative) and 
date signed, along with a statement that signing this addendum (or its 
updates) is only acknowledgement of receipt of the addendum (or its 
updates) and not the individual's (or representative's) agreement with 
the hospice's determinations. If a non-hospice provider or Medicare 
contractor requests the addendum, the non-hospice provider or Medicare 
contractor are not required to sign the addendum.
    (10) Date the hospice furnished the addendum.
    (d) Timeframes for the hospice election statement addendum. (1) If 
the addendum is requested within the first 5 days of a hospice election 
(that is, in the first 5 days of the hospice election date), the 
hospice must provide this information, in writing, to the individual 
(or representative), non-hospice provider, or Medicare contractor 
within 5 days from the date of the request.
    (2) If the addendum is requested during the course of hospice care 
(that is, after the first 5 days of the hospice election date), the 
hospice must provide this information, in writing, within 3 days of the 
request to the requesting individual (or representative), non-hospice 
provider, or Medicare contractor.
    (3) If there are any changes to the plan of care during the course 
of hospice care, the hospice must update the addendum and provide these 
updates, in writing, to the individual (or representative) in order to 
communicate these changes to the individual (or representative).
    (4) If the individual dies, revokes, or is discharged within the 
required timeframe for furnishing the addendum (as outlined in 
paragraphs (d)(1) and (2)

[[Page 19774]]

of this section, and before the hospice has furnished the addendum, the 
addendum would not be required to be furnished to the individual (or 
representative). The hospice must note the reason the addendum was not 
furnished to the patient and the addendum would become part of the 
patient's medical record if the hospice has completed it at the time of 
discharge, revocation, or death.
    (5) If the beneficiary dies, revokes, or is discharged prior to 
signing the addendum (as outlined in paragraphs (d)(1) and (2) of this 
section), the addendum would not be required to be furnished to the 
individual (or representative). The hospice must note the reason the 
addendum was not signed and the addendum would become part of the 
patient's medical record.
* * * * *
0
4. Section 418.76 is amended by revising paragraphs (c)(1) and 
(h)(1)(iii) to read as follows:


Sec.  418.76  Condition of participation: Hospice aide and homemaker 
services.

* * * * *
    (c) * * *
    (1) The competency evaluation must address each of the subjects 
listed in paragraph (b)(3) of this section. Subject areas specified 
under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section 
must be evaluated by observing an aide's performance of the task with a 
patient or pseudo-patient. The remaining subject areas may be evaluated 
through written examination, oral examination, or after observation of 
a hospice aide with a patient or a pseudo-patient during a simulation.
* * * * *
    (h) * * *
    (1) * * *
    (iii) If an area of concern is verified by the hospice during the 
on-site visit, then the hospice must conduct, and the hospice aide must 
complete, a competency evaluation of the deficient skill and all 
related skill(s) in accordance with paragraph (c) of this section.
* * * * *
0
5. Section 418.309 is amended by revising paragraphs (a)(1) and (2) to 
read as follows:


Sec.  418.309  Hospice aggregate cap.

* * * * *
    (a) * * *
    (1) For accounting years that end on or before September 30, 2016 
and end on or after October 1, 2030, the cap amount is adjusted for 
inflation by using the percentage change in the medical care 
expenditure category of the Consumer Price Index (CPI) for urban 
consumers that is published by the Bureau of Labor Statistics. This 
adjustment is made using the change in the CPI from March 1984 to the 
fifth month of the cap year.
    (2) For accounting years that end after September 30, 2016, and 
before October 1, 2030, the cap amount is the cap amount for the 
preceding accounting year updated by the percentage update to payment 
rates for hospice care for services furnished during the fiscal year 
beginning on the October 1 preceding the beginning of the accounting 
year as determined pursuant to section 1814(i)(1)(C) of the Act 
(including the application of any productivity or other adjustments to 
the hospice percentage update).
* * * * *
0
6. Section 418.312 is amended by revising paragraph (b) to read as 
follows:


Sec.  418.312  Data submission requirements under the hospice quality 
reporting program.

* * * * *
    (b) Submission of Hospice Quality Reporting Program data. (1) 
Standardized set of admission and discharge items Hospices are required 
to complete and submit an admission Hospice Item Set (HIS) and a 
discharge HIS for each patient to capture patient-level data, 
regardless of payer or patient age. The HIS is a standardized set of 
items intended to capture patient-level data.
    (2) Administrative data, such as Medicare claims data, used for 
hospice quality measures to capture services throughout the hospice 
stay, are required and automatically meet the HQRP requirements for 
Sec.  418.306(b)(2).
    (3) CMS may remove a quality measure from the Hospice QRP based on 
one or more of the following factors:
    (i) Measure performance among hospices is so high and unvarying 
that meaningful distinctions in improvements in performance can no 
longer be made.
    (ii) Performance or improvement on a measure does not result in 
better patient outcomes.
    (iii) A measure does not align with current clinical guidelines or 
practice.
    (iv) The availability of a more broadly applicable (across 
settings, populations, or conditions) measure for the particular topic.
    (v) The availability of a measure that is more proximal in time to 
desired patient outcomes for the particular topic.
    (vi) The availability of a measure that is more strongly associated 
with desired patient outcomes for the particular topic.
    (vii) Collection or public reporting of a measure leads to negative 
unintended consequences other than patient harm.
    (viii) The costs associated with a measure outweigh the benefit of 
its continued use in the program.
* * * * *

    Dated: March 29, 2021.
Elizabeth Richter,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: April 6, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-07344 Filed 4-8-21; 4:15 pm]
BILLING CODE 4120-01-P