[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Rules and Regulations]
[Pages 42528-42606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16311]



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Vol. 86

Wednesday,

No. 147

August 4, 2021

Part V





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Part 418





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

  Federal Register / Vol. 86 , No. 147 / Wednesday, August 4, 2021 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 418

[CMS-1754-F]
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: Final rule.

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SUMMARY: This final rule updates the hospice wage index, payment rates, 
and aggregate cap amount for Fiscal Year 2022. This rule makes changes 
to the labor shares of the hospice payment rates and finalizes 
clarifying regulations text changes to the election statement addendum 
that was implemented on October 1, 2020. In addition, this rule makes 
permanent selected regulatory blanket waivers that were issued to 
Medicare-participating hospice agencies during the COVID-19 public 
health emergency (PHE) and updates the hospice conditions of 
participation. This rule updates the Hospice Quality Reporting Program 
and finalizes changes beginning with the January 2022 public reporting 
for the Home Health Quality Reporting Program to address exceptions 
related to the COVID-19 PHE.

DATES: These regulations are effective on October 1, 2021.

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 
Lori Teichman at (410) 786-6684, Lauren Fuentes at (410) 786-2290, and 
Debra Dean-Whittaker at (410)786-9848.
    For questions regarding the hospice conditions of participation, 
contact Mary Rossi-Coajou at (410) 786-6051 and CAPT James Cowher at 
(410) 786-1948.
    For questions regarding 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:

I. Executive Summary

A. Purpose

    This rule updates 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 rebases the 
labor shares of the hospice payment rates and finalizes 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 provides a summary 
of comments received regarding hospice utilization and spending 
patterns. This rule makes permanent selected regulatory blanket waivers 
for hospice agencies during the COVID-19 public health emergency (PHE) 
and provides revisions to the hospice conditions of participation 
(CoPs). This rule finalizes changes to the Hospice Quality Reporting 
Program (HQRP), summarizes the comments to the requests for information 
on advancing to digital quality measurement and the use of Fast 
Healthcare Interoperability Resources (FHIR) and the White House 
Executive Order related to health equity in the HQRP. Finally, this 
rule finalizes 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 1899B(f) of the Act.

B. Summary of the Major Provisions

    Section III.A of this final rule includes a summary of comments 
from the public, including hospice providers as well as patients and 
advocates, regarding the presented analysis in the FY 2022 hospice 
proposed rule on hospice utilization, spending patterns and non-hospice 
spending during a hospice election.
    Section III.B of this final rule rebases and revises 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 of this rule updates the hospice wage index and makes 
the application of the updated wage data budget neutral for all four 
levels of hospice care and discusses the FY 2022 hospice payment update 
percentage of 2.0 percent, updates to the hospice payment rates, as 
well as the updates to the hospice cap amount for FY 2022 by the 
hospice payment update percentage of 2.0 percent.
    Section III.D finalizes 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 makes permanent selected regulatory blanket waivers 
that were issued to Medicare-participating hospice agencies during the 
COVID-19 PHE. We are revising the hospice aide requirements to allow 
the use of the pseudo-patient for conducting hospice aide competency 
evaluations. We are also revising the hospice aide supervision 
requirements to address situations when deficient practice is noted and 
remediation is needed related to both deficient and related skills, in 
accordance with Sec.  418.76(c).
    In section III.F of this rule, we finalize 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 the Hospice 
Outcome and Patient Evaluation (HOPE) assessment instrument. We also 
finalize the public reporting change for one refresh cycle to report 
less than the standard quarters of data due to the COVID-19 PHE 
exemptions; use 2 years (8 quarters) of data for the claims-based 
measures in order to report on small providers; and add the Consumer 
Assessment of Healthcare Providers and Systems (CAHPS[supreg]) Hospice 
Survey Star ratings. Additionally, we summarize the comments on the 
requests for information (RFI) on advancing to digital quality 
measurement and the use of FHIR and on addressing the White House 
Executive Order related to health equity in the HQRP.
    Finally, in section III.G of this rule, we are finalizing our 
proposal to the HH QRP so 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 included the HH QRP policy in this rulemaking in order to 
resume public reporting for the HH QRP with the January 2022 refresh of 
Care Compare. To accommodate the excepted HH QRP of 2020 Q1 and Q2, we 
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 January 2022 
refresh, which we release 3 months prior to any given refresh (October

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2021), we needed the rule containing this proposal to finalize by 
October 2021.

C. Summary of Impacts

    The overall economic impact of this final rule is estimated to be 
$480 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 Social Security Act (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 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 at no cost to the individual. 
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

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does not pay for these volunteer services (section 1861(dd)(2)(E) of 
the Act). As stated in the Fiscal Year (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 (routine home 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 are 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 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

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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.
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) 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 Hospice Quality Reporting Program (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 Consumer Assessment of Healthcare Providers and Systems 
(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

[[Page 42532]]

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 Consolidated Appropriations Act, 2021 
(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 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 Final Rule

A. Hospice Utilization and Spending Patterns

    In the FY 2022 proposed rule (86 FR 19700), CMS provided data 
analysis on hospice utilization trends from FY 2010 through FY 2019. 
The analysis included 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. The proposed rule also solicited comments 
from the public, hospice providers, patients and advocates regarding 
hospice utilization and spending patterns. We also solicited 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 and 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 solicited comments on what other factors may influence 
whether or how certain services are furnished to hospice beneficiaries. 
Finally, we requested feedback from stakeholder 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. A 
summary of these comments and our response to those comments appear 
below:
1. Hospice Utilization and Spending Patterns
    Several commenters thanked CMS for continuing to incorporate 
monitoring and data analysis into its proposed hospice payment rule. 
Many commenters stated that while the structure of the hospice benefit 
and approach to care at the end of life remain unchanged, changes in 
the characteristics of patients served (particularly the shift from 
predominantly cancer patients to those with end-stage neurological and 
other conditions) is largely responsible for driving changes in 
utilization trends and hospice practice over recent decades. Many 
commenters suggested that CMS provide more detailed analysis of 
physician billing as it relates to non-hospice spending and a few 
commenters suggested that CMS release additional data connected to CMS' 
Part D spending analysis to better inform stakeholders and assist in 
helping to determine what factors may be contributing to these 
increased Part D expenditures during a hospice election.
2. Skilled Visits in the Last Days of Life
    One commenter stated that the service intensity add-on (SIA) 
payment has been one of the greatest improvements in the hospice 
benefit in recent years. Many commenters recommended that CMS modify 
the SIA payments to include any visits which could be counted toward 
end-of-life care, not just skilled visits (for example, chaplain and 
spiritual care or hospice aide).
3. Items, Services, and Drugs Related and Unrelated to the Terminal 
Illness and Related Conditions
    Several commenters stated that the determination of relatedness, as 
applied to coverage decisions connected to terminal prognosis, is a 
clinical decision specific to the unique clinical circumstances of each 
patient. Several commenters stated that they work in collaboration with 
their respective IDGs to determine the items, services, and drugs that 
are related versus unrelated once the comprehensive assessment is 
completed.
4. Election Statement Addendum
    Several commenters stated that the addendum has not changed their 
practices for determining what is related or unrelated under the 
hospice benefit, but has enhanced the upfront communication with 
patients and representatives during the admission process. One 
commenter stated that their hospice revisited the way relatedness is 
defined, and realized that many diagnoses that were previously thought 
to be unrelated were related. Another commenter stated that very few 
patients and their representatives have requested the addendum and that 
the burden of implementation of the addendum outweighs the benefits.
    We appreciate the comments provided regarding the analysis 
presented in the proposed rule. We plan continue to monitor hospice 
trends and vulnerabilities within the hospice benefit. We will consider 
these comments and suggestions for ongoing monitoring analyses, program 
integrity efforts, and for potential future rulemaking.

B. FY 2022 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

[[Page 42533]]

skilled nursing facility costs per day (48 FR 38155 through 38156; 56 
FR 26917).
    In the FY 2022 proposed rule (86 FR 19717 through 19719), we 
proposed to rebase and revise the labor shares for CHC, RHC, IRC and 
GIP using Medicare cost report (MCR) data for freestanding hospices 
(collected via CMS Form 1984-14, OMB NO. 0938-0758) for 2018. We 
proposed 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 as well as a summary of the comments 
received and our responses.
    Twenty unique stakeholders submitted their comments on the proposal 
to rebase the hospice labor shares. In response to public comments, we 
are adopting the revised hospice labor shares calculated as we proposed 
with a slight modification to the methodology.
    Comment: A few commenters supported the proposal to rebase the 
labor share for the four levels of care based on the 2018 MCR data. One 
commenter supported the proposed methodology of using actual hospice 
cost report data calculated using all applicable costs as well as 
including only providers who performed each level of care normalizing 
for outliers. Another commenter stated it was appropriate that the 
hospice labor shares be based on data for hospice providers, rather 
than home health agencies and skilled nursing facilities. Several 
commenters stated that basing the hospice labor shares on recent MCR 
data for hospice providers will improve payment accuracy.
    One commenter strongly encouraged CMS not to revise the labor share 
using the 2018 MCR for freestanding hospices. One commenter opposed the 
proposed labor shares, stating that the data in the cost report do not 
provide adequate or appropriate measures of labor expenses. One 
commenter agreed with the increased labor share for CHC and for IRC, 
but did not agree with lowering the labor share for RHC and GIP. One 
commenter acknowledged the rationale for using hospice cost report 
data, but stated that this will reduce reimbursement for many of their 
members, particularly those who provide more GIP than average.
    Response: We believe that our proposal to revise the labor shares 
based on MCR data for hospice providers is a technical improvement to 
the current labor shares and appreciate the support from the 
commenters.
    We disagree with commenters that the hospice MCR data does not 
provide adequate or appropriate measure of labor expenses. The MCR data 
captures detailed labor and non-labor expenses for patient (including 
but not limited to nursing, physician, therapy and medical supply 
expenses) and non-patient expenses (such as administrative and general) 
by level of care. We would note that the freestanding hospice MCR data 
was used to rebase the hospice payment rates effective for FY 2020 (84 
FR 38487 to 38496). In addition, we remind providers that when 
submitting the MCR data they must certify the cost report that ``to the 
best of [their] knowledge and belief, [the] report and statement are 
true, correct, complete and prepared from the books and records of the 
provider in accordance with applicable instructions, except as noted.''
    Comment: Several commenters expressed concern regarding the impact 
of COVID-19 on labor costs. Commenters stated that while they do not 
yet know the full extent of the impact on labor costs, they expect it 
to be significant. They stated that the PHE could considerably change 
the labor share in the next several years of cost report data, as the 
use of cost reports has a 2-year delay in data. These commenters stated 
that the impact of COVID-19 on the labor component of the rates cannot 
be captured in cost report data that is at least 2 years old. The 
commenters requested consideration of the impact of COVID-19 when 
setting labor shares for future years.
    Several other commenters stated that hospices face significant 
challenges in the labor market, particularly for nurses. They stated 
that more nurses are retiring, competition for available nurses is 
fierce, and many hospices are paying premium salaries and bonuses to 
recruit and retain qualified nursing staff. One commenter stated that 
the hospice per diem structure severely limits the amounts they can 
spend on staff. One commenter stated during the pandemic more time has 
been needed to train and retrain on infection control standards, as 
well as changes in communication due to practice changes.
    One commenter stated that it is difficult to attract nurses to 
their geographic area because of the increase in the median home price 
between January 2021 and May 2021. The commenter stated that they are 
forced to outsource many nursing functions at high cost, along with 
paying retention bonuses to current staff. The commenter stated that 
these labor market challenges will have an impact on the labor shares, 
which will not necessarily be reflected when the cost report data used 
is 2 years old. One commenter urged CMS to give special consideration 
to challenges faced by rural health care providers with specific 
attention given to the impact workforce shortages have in setting 
reimbursement rates related to the labor shares.
    Response: We acknowledge and appreciate the commenters' concerns 
regarding labor costs and understand the challenges created by the PHE. 
We believe using updated labor shares based on 2018 data is a technical 
improvement over the current labor shares as they reflect recent cost 
data for freestanding hospice providers. The current labor shares were 
primarily based on data from the early 1980s. The proposed labor shares 
reflect the skilled care (including the number of visits) provided 
under the hospice per diem payment rates for each level of care. For 
example, the higher labor share for CHC compared to RHC reflects the 
higher number of visits per day provided with CHC relative to RHC. The 
current labor shares did not reflect this differential in utilization 
as the same labor share was used for both levels of care.
    We plan on reviewing the 2020 hospice MCR data when complete 
information is available that will allow us to consider whether the 
hospice labor shares based on 2018 data are still appropriate. Any 
future revisions to the hospice labor shares will be proposed and 
subject to public comments in future rulemaking.
    Comment: Several commenters expressed concerns about the frequency 
of updating the labor shares in the future. A few of these commenters 
requested that CMS provide further clarification of the frequency of 
updates to the labor shares with hospice cost report data. One 
commenter stated that it is important that CMS address this frequency 
so that hospices and cost report preparers can ensure that the data 
submitted on the cost report can be used for the labor share 
calculations.
    Response: We acknowledge the commenters' concern that the proposed 
rule did not explicitly state when we plan to propose any revisions to 
the hospice labor shares beyond FY 2022.
    The labor shares for other PPS systems (for example, IPPS, SNF, 
IRF, IPF, and LTCH) are typically rebased every four to five years. We 
tentatively plan to rebase the hospice labor shares on a similar 
schedule as the other payment systems under Medicare. However, in light 
of the COVID-19 PHE, we plan to monitor the upcoming MCR

[[Page 42534]]

data to see if a more frequent revision to the hospice labor shares is 
necessary in order to reflect the most recent cost structures of 
hospice providers. We note that any future revisions to the hospice 
labor shares will be proposed and subject to public comments in future 
rulemaking.
    Comment: A few commenters stated that while they understand the 
desire and rationale for using hospice data to revise the hospice labor 
shares (and to make other policy changes), they believe it is important 
to recognize that the data inputs utilized must be appropriate to the 
task. The commenters stated that the hospice cost report in its current 
form does not suit all data purposes for hospice policy changes, and 
does not fully support calculation of the hospice payment rate labor 
shares.
    One commenter noted that the hospice cost report for freestanding 
providers is being proposed to be used for the first time to determine 
the labor component of the rates for each level of care. While the 
commenter commended CMS for using hospice-specific data, they were also 
concerned about the accuracy of the data submitted by providers.
    One commenter stated concern that due to hospice MCRs not being 
audited, as well as some sections of the cost report offering multiple 
methods of reporting, there is a general lack of consistency in the way 
that the reports are completed by hospice providers that will 
necessarily distort the average labor figures. The commenter was also 
concerned that it's not likely that most payroll applications used by 
hospice providers can correctly allocate costs by level of care, so due 
to different methods applied by hospice providers to estimate this, the 
labor costs will also be impacted.
    One commenter stated that there are no checks and balances on 
whether cost reporting data are accurate. They claimed that classifying 
costs across the four levels of care can contain inaccuracies, 
particularly when staff allocate time to various levels of care in the 
same working day. The commenter stated that there are no regulations 
that require cost reports to be completed by an outside or otherwise 
qualified accounting firm, and many hospices are doing their own costs 
reports without complete understanding of how to allocate specific 
costs and which box is appropriate for particular costs. They stated 
that the number of hospices that do not pass level 1 edits is also of 
concern.
    One commenter stated that they do not believe hospice cost reports 
are historically very accurate. They stated that in many healthcare 
systems someone from the accounting department completed the cost 
report form with very little input from the hospice program. The 
commenter stated that they never had an opportunity to review the cost 
report prior to submission to verify the information was accurate and 
that they believe this is a common occurrence across the country. 
Therefore, the commenter stated that they do not believe that cost 
reports capture labor costs very accurately.
    A few commenters stated that if data from the hospice cost report 
is to be used for calculating the labor component by level of care, 
revisions to the cost report should be proposed to address current 
inconsistent, but acceptable, reporting practices. Further, the 
commenters stated that these changes should be instituted to ensure 
greater accuracy of the data being used to establish labor shares for 
GIP and IRC. A few commenters stated that these changes should be 
implemented as quickly as possible, and once they are in place CMS 
should undertake a recalculation of the labor shares.
    Response: The freestanding hospice MCR form used for the proposed 
labor shares (CMS-1984-14; OMB NO. 0938-0758) was revised effective for 
cost reporting periods beginning on or after October 1, 2014 in 
response to section 1814(i)(6) of the Act, as added by section 
3132(a)(1)(B) of the PPACA, which 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.
    CMS form 1984-14 was proposed and subject to public comments. 
Hospice providers previously completed MCR form (CMS-1984-89, OMB NO. 
0938-0758). The revised MCR enabled CMS to collect more detailed data 
regarding labor costs by level of care. The prior MCR did not collect 
total costs by level of care or detailed costs by level of care (such 
as labor and nonlabor).
    We disagree with the commenter that the cost report in its current 
form does not support the calculation of the hospice payment rate labor 
shares. Providers are required to report detailed patient costs 
(including but not limited to nursing, physician, therapy, and medical 
supplies) and non-patient costs for each level of care. These costs are 
further subdivided into labor and non-labor costs.
    Our proposal to use the 2018 MCR data recognizes that providers 
have had 4 years to familiarize themselves with the form and, thereby, 
improve the accuracy of the data. We note that based on comments 
received during the CMS-1984-14; OMB NO. 0938-0758 clearance process, 
the implementation of the MCR form was delayed to October 1, 2014. In 
addition, as stated previously, providers must certify the cost report 
that ``to the best of [their] knowledge and believe, [the] report and 
statement are true, correct, complete and prepared from the books and 
records of the provider in accordance with applicable instructions, 
except as noted.'' Nonetheless, we recognize that data can be 
misreported at times and, therefore, our proposal for revising the 
labor shares included applying several edits to remove possible outlier 
data--a common statistical practice.
    We continue to encourage hospice providers to report accurate and 
complete data on the cost reports. We will evaluate and consider any 
future changes to the hospice cost report that will allow for the 
collection of data that may improve the calculation of the hospice 
labor shares. In addition, we will monitor the compensation cost 
weights reported by hospices over time to determine if changes to the 
labor share are appropriate. Any future changes to the cost report or 
labor shares would be subject to public comments.
    While we acknowledge that hospice providers can use different 
methodologies for reporting data, we believe that our proposed 
methodology allows for these differences and still results in a 
reasonable and accurate measure of the cost structures of hospice 
facilities.
    The proposed labor shares are based on MCR data for freestanding 
hospice facilities. As stated in the proposed rule, 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.
    Comment: One commenter stated that the finances of freestanding 
hospices are significantly different than those of hospices based at 
hospitals, home health agencies and nursing homes; therefore, data from 
freestanding hospices should not be allowed to represent the industry 
as a whole.
    Response: As stated in the FY 2022 Hospice Wage Index and Rate 
Update proposed rule (86 FR 19717), we did

[[Page 42535]]

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 and so these reports were not usable. We also 
plan to continue to review the 2020 hospital-based hospice MCR data to 
see if the reporting of the detailed expense data by level of care has 
improved for possible incorporation into the labor share calculations. 
We would note that the freestanding hospice providers account for about 
85 percent of hospice providers and therefore, we believe our proposal 
to use only the freestanding hospice MCR data to revise the labor 
shares is reasonable and a technical improvement over the current labor 
shares.
2. Methodology for Calculating Compensation Costs
    We proposed 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 proposed to use the 
same methodology to derive the components; however, for the (1) direct 
patient care salaries and (3) other patient care salaries, we proposed 
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).
a. 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, 
RNs, and hospice aides. We proposed 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.
    Comment: One specific concern of the commenters regarding the 
proposed methodology was on the data used from Worksheet A-1 and A-2 
column 7, lines 26 through 37 for total labor costs associated with 
each respective level of care. The commenters stated that certain costs 
are not consistently reported by hospices despite these costs being in 
compliance with cost reporting instructions. For example, the 
commenters provided that some hospices track mileage allowances 
enabling them to be reported on Worksheet A-1 and A-2 while other 
hospices allocate these mileage reimbursement costs via Worksheet B and 
B-1 using miles traveled. The commenters asked CMS whether any 
consideration was given to this inconsistent, but acceptable, reporting 
for mileage allowances.
    Response: We appreciate the commenter's concern. The proposed 
methodology for calculating the labor shares cited by the commenter of 
using Worksheet A-1 and A-2 column 7, lines 26 through 37 for total 
labor costs reflects only one component of the proposed calculation of 
the labor share. As discussed in the FY 2022 Hospice proposed rule (86 
FR 19718) and above, we proposed to derive Direct patient care salaries 
and contract labor costs using (for CHC as an example) Worksheet A-1 
column 7, lines 26 through 37 on the cost report, which would capture 
any staff transportation costs reported in these cost centers on 
Worksheet A-1.
    Also included in the compensation costs for each level of care, as 
discussed in the FY 2022 Hospice proposed rule (86 FR 19718) and below, 
is a proportion overhead salaries and benefits. The overhead salaries 
includes those reported in the staff transportation cost center 
(reported in Worksheet A, column 1, line 12) and the overhead benefits 
for the staff transportation cost center (Worksheet B, column 3, line 
12).
    Therefore, after consideration of public comments, we believe that 
our proposed methodology is capturing both the direct patient care 
costs reported on Worksheet A-1 and any overhead salaries and overhead 
benefits related to staff transportation costs that are allocated on 
Worksheet B. We believe that the non-salary non-benefit costs for staff 
transportation that are allocated on Worksheet B (for example, cost of 
owning or renting vehicles) should not be included in the labor share 
of the hospice payment rate that is adjusted by the wage index, as they 
are not compensation costs, nor do they vary with the local labor 
market.
b. Direct Patient Care Benefits Costs
    We proposed that direct patient care benefits costs for CHC are 
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.
c. 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 nonsalary costs) for these services for each level of care 
on Worksheets A-1, A-2, A-3, A-4, column 7. Therefore, we proposed 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 proposed 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 proposed to 
multiply this ratio by total other patient care costs for RHC 
(Worksheet A-2, column 7, lines 38 through 46). For IRC, we proposed to 
multiply this ratio by total other patient care costs for IRC 
(Worksheet A-3, column 7, lines 38 through 46). For GIP, we proposed 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.
    Comment: One commenter stated that the proposed methodology for 
calculating compensation costs omits two of the required disciplines in 
a hospice patient's interdisciplinary team. They stated that social 
workers and counselors provide direct patient care along with nurses 
and hospice aides in both routine home care and general inpatient care. 
The commenter claimed that the proposed methodology only captures 
salaries and benefits of physicians, nurse practitioners, RNs and 
hospice aides. The commenter stated that this disregards the essence of 
the hospice interdisciplinary team which cares for the patient and 
family as a unit of care. Social workers and counselors serve both the 
patient and their family. Their salaries and benefits must also be 
captured in the methodology. The commenter stated that it is unclear in 
the proposed rule whether they are

[[Page 42536]]

included in ``Other Patient Care Salaries'' since only mentioned are 
patient transportation, labs and imaging services.
    Response: As stated in the FY 2022 hospice proposed rule (86 FR 
19717 through 19719) as well as above, we proposed that Direct patient 
care salaries and contract labor costs 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 
(86 FR 19718). These lines include Medical Social Services (line 33), 
Spiritual Counseling (line 34), Dietary Counseling (line 25), and 
Counseling Other (line 36). Therefore, we proposed to include direct 
patient care salaries and contract labor for social workers and 
counselors in the calculation of the labor shares.
d. 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 proposed to 
calculate noncapital nonbenefit 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 proposed to multiply these noncapital 
nonbenefit 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 noncapital nonbenefit 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).
e. Overhead Benefits Costs
    To estimate overhead benefits costs for each level of care, we 
proposed a similar methodology to overhead salaries. For each level of 
care, we proposed 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 proposed to multiply these 
noncapital 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.
    Comment: Another specific concern raised by the commenters was that 
there are inconsistencies in reporting medical supply and pharmacy 
costs on line 10 and line 14 of Worksheet A. They stated that some 
hospices use Worksheets A-1, A-2, A-3, and A-4 to report all or most of 
these costs whereas others use lines 10 and lines 14 and report costs 
as overhead costs. The commenters recommended that CMS look further 
into reporting all pharmacy and medical supply costs as direct patient 
care costs on future cost reports. The commenter stated that other 
acceptable cost reporting methods may be applicable; however, a Level 1 
edit is not currently produced if costs are reported in one of the two 
acceptable locations.
    Response: As described in the FY 2022 hospice proposed rule (86 FR 
19717 through 19719), our proposed calculation to derive the hospice 
labor shares uses the sum of five categories of compensation costs. The 
estimated compensation costs related to medical supply and pharmacy 
costs would be reflected in the Other Patient Care Salaries, Overhead 
Salaries, and Overhead Benefits categories. We proposed that total 
costs for CHC be 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. These total costs would reflect medical supply and 
pharmacy costs when reported on Worksheet A line 10 and 14 or when 
reported on Worksheet A-1, A-2, A-3, and A-4. Therefore, we believe our 
proposed methodology captures these costs appropriately. However, we 
will consider this comment when requesting any future revisions to the 
Level 1 edits applied to the hospice cost report.
    Comment: One commenter had concerns with the inconsistent reporting 
of certain types of overhead expenses among hospices. They stated in 
some instances, Medical Directors are employees and salaries would be 
reported; however, other hospices contract for this position. The 
commenter stated that the contracted payments for Medicare Directors 
are not included in the proposed calculation of overhead salaries. The 
commenter asked whether any consideration was made regarding this 
inconsistency or other common inconsistencies in the nature of the 
expenses.
    Response: We appreciate the commenter's concern and conducted an 
additional review of our proposed methodology for appropriately 
capturing overhead costs in the labor shares.
    As noted by the commenter, salaries and benefit costs for employed 
Medical Directors would be reported in Worksheet A, column 1, line 15 
(salaries) and Worksheet B, column 3, line 15 (benefits), which are 
both included in our proposed methodology as these expenses are 
reported in overhead salaries and overhead benefits. As described in 
the proposed rule (86 FR 19718) and above, we include a proportion 
overhead salaries and overhead benefits in the compensation cost 
weights for each level of care.
    However, after performing a detailed review of the calculation, we 
acknowledge that Medical Director contract labor costs would be 
reported in Worksheet A, column 2, line 15, which we do not include in 
the proposed compensation cost weight. In addition to Physician 
Administrative Services (line 15), we identified one additional 
overhead cost center where contract labor costs for patient care are 
reported and not reflected in the labor shares for each level of care: 
Nursing Administration (line 9). We believe these cost centers 
(Physician Administrative Services and Nursing Administration) are 
labor-intensive and vary with the local labor market and, thus, we 
believe contract labor costs for these services should be included in 
the labor shares for each level of care. Therefore, in response to 
public comment, we are revising our methodology for calculating 
overhead benefits attributable to each level of care. We are including 
in total facility overhead benefits those costs reported in Worksheet 
A, column 2, lines 9 and 15. A proportion of overhead benefit costs are 
allocated to each level of care using our methodology as stated above 
and in the proposed rule (86 FR 19718). This revision to our labor 
share methodology results in upward revisions to the proposed labor 
shares for each of the levels of care (between 0.6 percentage point and 
1.1 percentage point). The labor shares showing the revised methodology 
are provided in Table 1.
f. Total Compensation Costs and Total Costs
    To calculate the compensation costs for each provider, we proposed 
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 proposed 
that total costs

[[Page 42537]]

for CHC are equal to Worksheet B, column 18, line 50, for RHC are equal 
to Worksheet B, column 18, line 51, for IRC are equal to Worksheet B, 
column 18, line 52, and for GIP are equal to Worksheet B, column 18, 
line 53.
3. Methodology for Deriving Compensation Cost Weights
    To derive the compensation cost weights for each level of care, we 
first proposed 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.\3\ 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).
---------------------------------------------------------------------------

    \3\ 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 proposed to further 
trim the sample of MCRs. We outline our proposed trimming methodology 
using CHC as an example. Specifically, for CHC, we proposed that total 
CHC costs (Worksheet B, column 18, line 50) and CHC compensation costs 
to be greater than zero. We also proposed that CHC direct patient care 
salaries and contract labor costs per day is greater than 1. We also 
proposed to exclude those providers whose CHC compensation costs were 
greater than total CHC costs.
    For the IRC and GIP compensation cost weights, we proposed to only 
use those MCRs from providers that provided inpatient services in their 
facility. Therefore, we proposed 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.
    Comment: One commenter stated that many of the hospice cost reports 
filed in 2018 failed to report contracted GIP days and contracted IRC 
care days on Worksheet S-1. Instead, they included all these days on 
line 23 and 33 of Worksheet S-1 but failed to report contracted days on 
line 40 and 41 of Worksheet S-1. The commenter stated that the failure 
to report contracted days on lines 40 and 41 would avoid a Level 1 edit 
if costs were not reported on Worksheets A-3 and A-4, line 25. The 
commenter stated that they understand that this reporting is 
inaccurate; however, there is no existing Level 1 edit that would catch 
it. The commenter questioned how CMS is determining that the inpatient 
costs are related solely to a freestanding inpatient unit on Worksheet 
A-4. The commenter claimed that if it is solely because no costs are 
reported on line 25, this assumption is in error. The commenter also 
claimed that if it is based on no days being reported as contracted on 
Worksheet S-1, this assumption is also in error. The commenter was 
concerned that costs--and accordingly labor component costs--are based 
on a small population with high risk of error.
    One commenter stated that with only those cost reports from 
providers that have a hospice inpatient unit being used to determine 
the GIP and inpatient respite labor costs, they are concerned because 
one of their two affiliated hospices does have an inpatient unit, and 
yet they sometimes refer patients to contracted facilities for these 
levels of care as well. The commenter stated that it appears that the 
percentage of hospice cost reports used for determining GIP and respite 
total costs and labor-component costs is based on a small population of 
hospice providers with a significant risk of error; therefore, the 
commenter recommended that CMS rethink its approach for GIP and respite 
labor costs.
    One commenter stated that their hospice utilizes general inpatient 
contracts, as they do not have our own facility. Thus, inpatient 
services on line 25 are not captured.
    Response: We appreciate the commenters' concerns on the accuracy of 
the IRC and GIP cost data on the MCR. As stated in the FY 2022 Hospice 
proposed rule (86 FR 19718 through 19719) and above, for purposes of 
calculating the IRC and GIP compensation cost weights, we excluded 
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. Then, for 
each level of care separately, we further trimmed the sample of cost 
reports. Specifically, for IRC, we required total IRC costs (Worksheet 
B, column 18, line 52) and IRC compensation costs to be greater than 
zero. We also required that IRC direct patient care salaries and 
contract labor costs per day would be greater than 1. We also excluded 
those providers whose IRC compensation costs were greater than total 
IRC costs. We then simultaneously removed those providers whose total 
IRC costs per day fall in the top and bottom one percent of total IRC 
costs per day for all IRC providers as well remove those providers 
whose compensation cost weight falls in the top and bottom five percent 
of compensation cost weights for all IRC providers.
    We did not exclude providers based on the reporting of contracted 
inpatient days as reported on Worksheet S-1. In response to the public 
comment, we did test applying an additional edit that would exclude 
providers who reported contracted inpatient days on Worksheet S-1 as 
part of our basic trims. This excluded two providers and had no impact 
on the compensation cost weights for both IRC and GIP when rounded to a 
tenth of a percentage point. We encourage providers to report their 
cost report data accurately and timely.
    Comment: Another specific concern stated by the commenters was that 
the determination of the labor share for GIP and IRC is based on 
Worksheet A-3 and A-4; however, any hospices reporting costs on line 25 
(contracted services) were not included in the sample used for setting 
the labor share. The commenters recognize that the inclusion of any 
costs on line 25 would distort the labor component for these inpatient 
services; however, the commenters' experience indicates that most 
hospices with inpatient units also contract for some inpatient days 
with outside providers for a variety of reasons. The commenters stated 
that many of these hospices providers have some of the best accounting 
records in the industry and the proposed methodology for calculating 
the labor components eliminates the costs of these facilities from 
consideration. The commenters stated that the proposed rule indicates

[[Page 42538]]

that 20 percent of IRC and 28 percent of GIP providers were included in 
the calculation. The commenters requested that CMS provide the final 
number of hospices with inpatient units that were used in the 
calculation of the labor components for both levels of care, and the 
total universe of IRC and GIP providers. One commenter also stated that 
they were interested in how the percentage of hospices that operate 
inpatient facilities can be increased and all costs, including 
contracted costs, can be included.
    Response: The proposed hospice labor shares for the IRC level of 
care and GIC level of care (after trimming for outliers) is based on 
costs for 416 and 295 providers, respectively. These providers 
reflected approximately 53,000 IRP days of which about 47,000 were 
Medicare and approximately 136,000 GIC days of which about 108,000 were 
Medicare. Although this a smaller sample of providers than used for the 
other proposed labor shares for RHC (2,919 providers) and CHC (1,240 
providers), we believe this is a technical improvement to the current 
labor shares that were primarily based on skilled nursing facility 
costs from the early 1980s. Our proposed methodology utilizes 
freestanding hospice cost report data reflecting the skilled hospice 
care provided in 2018 and the associated direct and indirect costs 
required to provide these services in 2018. We encourage all providers 
to report the cost report data accurately and timely so we can include 
more providers' cost report data in the labor share calculations. We 
will monitor the cost report data to determine whether the proposed 
updated labor shares are still appropriate.
    Comment: Another specific concern raised by commenters was that the 
cost reports should be amended to allow for a greater breakdown of 
costs for contracted vs. hospice-administered inpatient services. 
Specifically, one commenter stated that when the cost report was 
revised in 2014, some industry experts recommended that CMS develop two 
separate worksheets for IRC and GIC. The first worksheet would 
represent costs associated with freestanding units operated by the 
hospice and the second worksheet would be for costs associated with 
contracted services. The commenter stated CMS should see value in 
potentially adding these worksheets if, in fact, it intends to 
calculate labor components for these levels of care based on cost 
report data going forward. The commenter also recommended that CMS 
could add a question to the cost report asking whether the hospice 
operates a freestanding inpatient and/or inpatient respite care 
facility. A ``no'' answer would require reporting contracted days and 
contracted costs or produce a Level 1 edit. The commenter stated that 
this would better allow CMS to isolate the costs of those facilities 
that truly operate an inpatient unit.
    One commenter requested that CMS work with stakeholders and the 
hospice community to identify the best approaches, and separate 
worksheets, for GIP and inpatient respite costs, including both 
hospices that operate a freestanding facility and hospices that have 
contracted beds.
    Response: We appreciate the commenters request for future changes 
to the hospice cost report to allow us to better isolate costs of those 
facilities that operate an inpatient unit. As stated above, we believe 
that our current method for calculating the IRC and GIP compensation 
cost weights provides an accurate measure of the labor shares for these 
levels of care. We will consider this comment when working on any 
future modifications to the hospice cost report. We will also continue 
to monitor the hospice labor shares as more recent data become 
available. We note that any future revisions to the hospice labor 
shares will be proposed and subject to public comments in future 
rulemaking.
    Finally, as proposed, to derive the compensation cost weights for 
each level of care for each provider, we divide compensation costs for 
each level of care by total costs for each level of care. We then trim 
the data for each level of care separately to remove outliers. 
Following our example for CHC, we 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 limited 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 1) and, 
therefore, we believe our sample is representative of freestanding 
hospices providing inpatient hospice care.
    Comment: One commenter requested that clarification as to how CMS 
will adjust the labor share if certain types of hospices are found to 
provide more services and thus, likely have a larger labor share but 
contribute fewer cost reports.
    Response: As described in the FY 2022 Hospice proposed rule (86 FR 
17919) and above, the proposed compensation cost weights are equal to 
the sum of the compensation costs divided by the sum of the total costs 
for those remaining providers after trimming for outliers. Therefore, 
hospice providers with larger costs (reflecting larger utilization) 
would have a larger weight in the proposed labor shares. We would note 
that Medicare days, in aggregate, account for over 80 percent of total 
facility days. As stated previously, we will continue to monitor the 
labor shares over time and propose revisions to these shares to reflect 
a more recent cost structure and mix of providers.
    Comment: One commenter stated that given the inherent differences 
in the provision of the hospice benefit between different types of 
hospice providers, they would recommend that CMS monitor any 
significant disparities in the distribution of labor and non-labor 
inputs across the hospice industry by program characteristics. The 
commenter stated that they would become concerned, for instance, if 
data indicates that some providers offer significantly fewer hours of 
professional interdisciplinary team (IDT) care yet make up a 
disproportionate percentage of providers filing cost reports. This 
could lead to unintended negative consequences for those providers 
fulfilling the true spirit and intent of the benefit. Put simply, if 
cost reports and other data indicate a widening gap in labor inputs 
between for-profit and not-for-profit providers, then CMS should 
investigate this trend further.
    Response: We appreciate the commenter's concern regarding labor 
hours provided by type of facility. As we are able to obtain more 
recent cost report data, we will monitor the labor shares by ownership-
type over time.
    Comment: One commenter stated that if the labor shares are going to 
have a greater weight on CHC, hospices should

[[Page 42539]]

be allowed to use it effectively. The commenter recommended that the 
current continuous care timeframe change from midnight to midnight to a 
new time frame of noon to noon and that visits from other providers 
such as chaplains and home health aides count toward the continuous 
care timeframe.
    Response: While this comment is outside the scope of this rule as 
we did not make any proposals relating to our CHC policy, we thank the 
commenter for their recommendations and will take them under 
consideration for future rulemaking.
    Final Decision: In summary, in response to public comments, we are 
adopting the revised hospice labor shares calculated as we proposed 
with a slight modification to the methodology to derive the overhead 
benefit calculations as described previously. Table 1 provides the 
finalized labor share for each level of care based on the compensation 
cost weights we derived using our revised methodology. As we proposed, 
the labor shares are rounded 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). The revised labor shares will be implemented in a budget 
neutral manner through the use of labor share standardization factors.
[GRAPHIC] [TIFF OMITTED] TR04AU21.138

    We also received six comments on the use of the labor share 
standardization factor including hospices, national industry 
associations. A summary of these comments and our responses to those 
comments appear below:
    Comment: A few commenters requested more information regarding the 
labor share standardization factor; specifically, its purpose, and any 
anticipated future use of the factor.
    Response: The labor share standardization factor is applied to the 
FY 2022 hospice payment rates so that the aggregate payments do not 
increase or decrease due to changes in the labor share values. We 
proposed to implement the proposed hospice labor shares in a budget 
neutral manner which is consistent with our policy of implementing 
updates to the hospice wage index in a budget neutral manner as well as 
updates in other perspective payment systems such as the annual 
recalibration of the case-mix weights in home health and updates to the 
home health wage index. 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 final revised 
labor shares. By dividing total payments for each level of care (RHC 
days 1 through 60, RHC days 61+, CHC, IRC, and GIP) using the FY 2022 
wage index, current labor shares and payment rates for each level of 
care by the total payments for each level of care using the final 
revised labor shares and FY 2022 wage index and payment.
    Final Decision: We are finalizing the proposal to implement the 
hospice labor shares in a budget neutral manner through the use of the 
labor share standardization factors, so that the aggregate payments do 
not increase or decrease due to changes in the labor share values.

C. FY 2022 Hospice Wage Index and Rate Update

1. 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.

[[Page 42540]]

    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 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 proposed 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 final 
hospice wage index will 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 final FY 2022 hospice wage index will 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 final wage index value for Hinesville-Fort Stewart, Georgia is 
0.8635.
    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 proposed 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 final 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.
    We received seven comments on the proposed FY 2022 hospice wage 
index from various stakeholders including hospices, and national 
industry associations. A summary of these comments and our responses to 
those comments appear below:
    Comment: One commenter expressed concern that hospices in 
Montgomery County, Maryland are at a long-term competitive disadvantage 
due to what they refer to as a Medicare hospice Federal payment 
inequity involving CBSAs specifically when Metropolitan Divisions are 
present. The commenter stated that that hospices in Montgomery County 
should be reimbursed at the

[[Page 42541]]

same level as hospices in the Washington, DC area because Montgomery 
County has a similar cost of living and cost of doing business compared 
to Washington, DC and shares the same labor market when competing for 
labor. This commenter recommended several solutions to resolve this 
issue, including applying the outmigration hospital adjustment which is 
a hospital wage adjustment based on commuting patterns referenced in 
section 505 of the Medicare Prescription Drug, Improvement and 
Modernization Act of 2003 to the hospice wage index; allowing hospices 
serving patients in MSAs that are large enough to be subdivided into 
metropolitan divisions to opt for the higher wage index valuation 
within the MSA's respective CBSAs or providing a 1-year limited 
increase in hospice wage index payments in the Montgomery County 
Metropolitan Divisions as a short-term fix to this problem.
    Response: We thank the commenter for these recommendations. 
However, we continue to believe that the OMB's geographic area 
delineations represent a useful proxy for differentiating between labor 
markets and that the geographic area delineations are appropriate for 
use in determining Medicare hospice payments. Additionally, we do not 
believe that we have the authority to apply the outmigration hospital 
adjustment to the hospice wage index because it is specific to the 
commuting patterns of hospital employees. We also do not believe it 
would be appropriate to allow hospices to opt for or be assigned a 
higher CBSA designation based on subdivided metropolitan divisions. 
Finally, in the FY 2021 Hospice Wage Index and Payment Rate Update 
final rule (85 FR 47079), we finalized a 1-year transition 5 percent 
cap on wage index decreases for fiscal year (FY) 2021 only. We believe 
that this transition was sufficient in order to mitigate the resulting 
short-term instability and negative impacts on certain providers after 
the implementation of the new OMB labor market delineations. We do not 
believe that a 1-year limited increase in hospice wage index payments 
for hospices specifically in the Montgomery County Metropolitan 
Divisions is appropriate at this time.
    Based on the OMB's current delineations, Montgomery County belongs 
in a separate CBSA from the areas defined in the Washington-Arlington-
Alexandria, DC-VA CBSA. Unlike inpatient prospective payment system 
(IPPS) hospitals, inpatient rehabilitation facilities (IRFs), and 
skilled nursing facilities (SNFs), where each provider uses a single 
CBSA, hospice agencies may be reimbursed based on more than one wage 
index. Payments are based upon the location of the beneficiary for 
routine and continuous home care or the location of the facility for 
respite and general inpatient care. Hospices in Montgomery County, 
Maryland may provide RHC and CHC to patients in the ``Washington-
Arlington-Alexandria, DC-VA'' CBSA and to patients in the ``Baltimore-
Columbia-Towson, Maryland'' CBSA. We have used CBSAs for determining 
hospice payments since FY 2006. Additionally, other provider types, 
such as IPPS hospitals, home health agencies (HHAs), SNFs, IRFs, and 
the dialysis facilities all use CBSAs to define their labor market 
areas. We believe that using the most current OMB delineations provides 
a more accurate representation of geographic variation in wage levels 
and do not believe it would be appropriate to allow hospices to be 
assigned a higher CBSA designation or to allow 1-year limited increase 
in hospice wage index payments for hospices only in the Montgomery 
County Metropolitan Divisions.
    Comment: One commenter recommended CMS institute a policy that no 
hospice be paid below the rural floor for their state, allow hospices 
and other post-acute providers to utilize a reclassification board 
similar to hospitals, and consider working with the Congress on 
policies to reform the wage index such as revisiting MedPAC's 2007 
proposal which recommended that the Congress repeal the existing 
hospital wage index statute, including reclassifications and 
exceptions, and give the Secretary authority to establish new wage 
index systems. In chapter 6 of the June 2007 Report to Congress, MedPAC 
recommended the new wage index should: Use wage data from all employers 
and industry-specific occupational weights, adjust for geographic 
differences in the ratio of benefits to wages, adjust at the county 
level and smooth large differences between counties, and be implemented 
so that large changes in wage index values are phased in over a 
transition period.\4\ Another commenter recommended that CMS develop 
and implement a wage index model that is consistent across all provider 
types so that all types of providers have a level playing field from 
which to compete for personnel.
---------------------------------------------------------------------------

    \4\ Report to Congress, Promoting Greater Efficiency in 
Medicare. MedPAC. June 2007. http://www.medpac.gov/docs/default-source/reports/Jun07_EntireReport.pdf.
---------------------------------------------------------------------------

    Response: We appreciate the commenters' recommendations; however, 
these comments are outside the scope of the proposed rule. Any changes 
to the way we adjust hospice payments to account for geographic wage 
differences, beyond the wage index proposals discussed in the FY 2022 
Hospice Wage Index and Rate Update proposed rule, would have to go 
through notice and comment rulemaking. While CMS and other stakeholders 
have explored potential alternatives to the current CBSA-based labor 
market system, no consensus has been achieved regarding how best to 
implement a replacement system.
    Additionally, the regulations that govern hospice reimbursement do 
not provide a mechanism for allowing hospices to seek geographic 
reclassification or to utilize the rural floor provisions that exist 
for IPPS hospitals. The reclassification provision found in section 
1886(d)(10) of the Act is specific to hospitals. Section 4410(a) of the 
Balanced Budget Act of 1997 (Pub. L. 105-33) provides that the area 
wage index applicable to any hospital that is located in an urban area 
of a state may not be less than the area wage index applicable to 
hospitals located in rural areas in that state. This rural floor 
provision is also specific to hospitals. Because the reclassification 
provision and the hospital rural floor applies only to hospitals, and 
not to hospices, we continue to believe the use of the pre-floor and 
pre-reclassified hospital wage index results in the most appropriate 
adjustment to the labor portion of the hospice payment rates. We remind 
stakeholders that the hospice wage index does include the hospice floor 
which is applicable to all CBSAs, both rural and urban. Pre-floor, pre-
reclassified hospital wage index values below 0.8 are adjusted by a 15 
percent increase subject to a maximum wage index value of 0.8.
    Comment: A few commenters stated that providers should be protected 
against substantial payment reductions due to dramatic reductions in 
wage index values from one year to the next. One commenter recommended 
that CMS maintain the 5 percent cap that was put in place for FY 2021 
or lower the cap to 3 percent to protect hospice providers who are 
already operating with negative or razor thin operating margins. 
Another commenter expressed concern regarding the adoption of the New 
Brunswick-Lakewood, NJ CBSA and recommended CMS adopt a transition 
policy that holds the FY 2022 and FY 2023 wage index for all affected 
facilities harmless from any reduction relative to their FY 2021 wage 
index.

[[Page 42542]]

    Response: We appreciate the concerns sent in by the commenters 
regarding the impact of wages index changes from year to year as well 
as the concerns from providers who have been impacted by the 
implementation of the New Brunswick-Lakewood, NJ CBSA designation. 
While, we understand the commenters' concern regarding the potential 
financial impact, we believe that the OMB delineations for Metropolitan 
and Micropolitan Statistical Areas are appropriate for use in 
accounting for wage area differences and that the values computed under 
the delineations result in more appropriate payments to providers by 
more accurately accounting for and reflecting the differences in area 
wage levels. In the FY 2021 Hospice Wage Index and Payment Rate Update 
final rule (85 FR 47079), we finalized a 1-year transition for fiscal 
year (FY) 2021 only, to mitigate the resulting short-term instability 
and negative impacts on certain providers and to provide time for 
providers to adjust to their new labor market delineations. We believe 
that the 1-year 5 percent cap transitional policy provided for FY 2021 
was an adequate safeguard against any significant payment reductions, 
allowed for sufficient time to make operational changes for future 
fiscal years, and provided a reasonable balance between mitigating some 
short-term instability in hospice payments and improving the accuracy 
of the payment adjustment for differences in area wage levels.
    We note that certain changes to wage index policy may significantly 
affect Medicare payments. These changes may arise from revisions to the 
OMB delineations of statistical areas resulting from the decennial 
census data, periodic updates to the OMB delineations in the years 
between the decennial censuses, or other wage index policy changes. 
While we consider how best to address these potential scenarios in a 
consistent and thoughtful manner, we reiterate that our policy 
principles with regard to the wage index include generally using the 
most current data and information available and providing that data and 
information, as well as any approaches to addressing any significant 
effects on Medicare payments resulting from these potential scenarios, 
in notice and comment rulemaking.
    Final Decision: We are finalizing our proposal to use the FY 2022 
pre-floor, pre-reclassified hospital wage index data as the basis for 
the FY 2022 hospice wage index. The wage index applicable for FY 2022 
is available on our website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index. The hospice wage 
index for FY 2022 is effective October 1, 2021 through September 30, 
2022.
2. 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 \5\ we proposed 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 (86 FR 25416 through 25428).
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    \5\ IPPS Regulations and Notices. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/IPPS-Regulations-and-Notices.
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    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).
    In the FY 2022 Hospice Wage Index and Payment Rate Update proposed 
rule (86 FR 19720), we proposed the market basket percentage increase 
of 2.5 percent for FY 2022 using the most current estimate of the 
inpatient hospital market basket (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 for FY 2022 of 2.5 percent was reduced by a productivity 
adjustment as mandated by Affordable Care Act (estimated in the 
proposed rule to be 0.2 percentage point for FY 2022). Therefore, the 
proposed hospice payment update percentage for FY 2022 was 2.3 percent.
    We also stated if more recent data became available after the 
publication of the proposed rule and before the publication of the 
final rule (for example, more recent estimates of the inpatient 
hospital market basket update and/or productivity adjustment), we would 
use such data to determine the hospice payment update percentage for FY 
2022 in the final rule. For this final rule, based on IHS Global Inc.'s 
(IGI) second quarter 2021 forecast with historical data through the 
first quarter 2021 of the inpatient hospital market basket update, the 
market basket percentage increase for FY 2022 is 2.7 percent. The 
productivity adjustment for FY 2022, based on IGI's second quarter 2021 
forecast, is 0.7 percent. Therefore, the hospice payment update 
percentage for FY 2022, based on more recent data, is 2.0 percent.
    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 rule, we are finalizing to rebase and revise the labor shares for 
CHC, RHC, GIP and IRC using MCR data for freestanding hospices (CMS 
Form 1984-14, OMB Control Number 0938-0758) for 2018. We are finalizing 
the labor portion of the payment rates to be for CHC, 75.2 percent; for 
RHC, 66.0 percent; for GIP, 63.5 percent; and for IRC, 61.0 percent. 
The non-labor portion is equal to 100 percent minus the labor portion 
for each level of care. Therefore, we are finalizing the non-labor 
portion of the payment rates to be as follows: For CHC, 24.8 percent; 
RHC, 34 percent; for GIP, 36.5 percent; and For IRC, 39.0 percent.
    Comment: We received seven comments in support of the proposed 
hospice update percentage of 2.3 percent. However, in its comment, 
MedPAC ``concluded that the aggregate level of payments could be 
reduced and would still be sufficient to cover hospice providers' costs 
and preserve beneficiaries' access to care.'' Therefore, MedPAC 
recommended a zero percent update for FY 2022 for all hospice 
providers.
    Response: We appreciate the support from commenters as well as 
MedPAC's concerns. However, section 1814(i)(1)(C)(iii) of the Act 
requires the Secretary, for years subsequent to the first fiscal year 
in which payment revisions described in paragraph (6)(D) are 
implemented, to update the payment rates by the market basket 
percentage increase (as defined in section 1886(b)(3)(B)(iii)) of the 
Act for the

[[Page 42543]]

fiscal year; section 1814(i)(1)(C)(iv)(I) of the Act requires that 
subsequent to such increase, the payment rates be reduced by the 
productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of 
the Act.
    Final Decision: We are finalizing the hospice payment update 
percentage of 2.0 percent for FY 2022. Based on IHS Global, Inc.'s more 
recent forecast of the inpatient hospital market basket update and the 
productivity adjustment, the hospice payment update percentage for FY 
2022 will be 2.0 percent for hospices that submit the required quality 
data and 0.0 percent (FY 2022 hospice payment update of 2.0 percent 
minus 2.0 percentage points) for hospices that do not submit the 
required data.
3. 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. 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 to ensure that SIA payments are budget-neutral. At the beginning 
of every fiscal year, 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 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 used FY 2020 claims data for the FY 2022 
payment rate updates.
    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 total 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 
total payments using the FY 2022 wage index and FY 2021 payment rates, 
we obtain a wage index standardization factor for each level of care. 
As stated above, 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 final revised labor shares. By 
dividing total payments for each level of care (RHC days 1 through 60, 
RHC days 61+, CHC, IRC, and GIP) using the current labor shares and FY 
2022 wage index and payment rates for each level of care by the total 
payments for each level of care using the final revised labor shares 
and FY 2022 wage index and payment rates for each level of care, we 
obtain a labor share standardization factor for each level of care. The 
wage index and labor share standardization factors for each level of 
care are shown in the Tables 2 and 3.
    The FY 2022 RHC rates are shown in Table 2. The FY 2022 payment 
rates for CHC, IRC, and GIP are shown in Table 3.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR04AU21.139


[[Page 42544]]


[GRAPHIC] [TIFF OMITTED] TR04AU21.140

    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 FY 
2022 rates for hospices that do not submit the required quality data 
would be updated by the FY 2022 hospice payment update percentage of 
2.0 percent minus 2 percentage points. These rates are shown in Tables 
4 and 5.
[GRAPHIC] [TIFF OMITTED] TR04AU21.141


[[Page 42545]]


[GRAPHIC] [TIFF OMITTED] TR04AU21.142

BILLING CODE 4120-01-C
    Final Decision: We are implementing the updates to hospice payment 
rates as discussed in the proposed rule.
4. 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, the IMPACT Act requires 
that, for accounting years that end after September 30, 2016 and before 
October 1, 2025, the hospice cap be 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 
proposed conforming regulation text changes at Sec.  418.309 to reflect 
the new language added to section 1814(i)(2)(B) of the Act.
    The hospice cap amount for the FY 2022 cap year will be $31,297.61, 
which is equal to the FY 2021 cap amount ($30,683.93) updated by the FY 
2022 hospice payment update percentage of 2.0 percent.
    Comment: Generally, commenters supported the update to the cap 
amount. We received a comment indicating some hospice agencies never 
hit the cap amount and recommend for CMS to utilize available claims 
and quality data to target hospices with questionable practices to 
avoid exceeding the cap amount.
    Response: We appreciate the concern and recommendation. We 
encourage those who have concerns about fraud, waste, or abuse to 
report these to CMS Center for Program Integrity. Resources can be 
found at https://www.cms.gov/About-CMS/Components/CPI.
    Comment: MedPAC recommended the hospice cap amount be reduced by 20 
percent as a way to focus payment reductions on providers with 
particularly high margins. MedPAC also recommended wage adjusting the 
hospice cap amount to make it more equitable across providers.
    Response: We appreciate MedPAC's comments; however, we are required 
by law to update the hospice cap amount from the preceding year by the 
hospice payment update percentage, in accordance with section 
1814(i)(2)(B)(ii) of the Act. Therefore, we do not have the statutory 
authority to reduce the aggregate cap amount nor the statutory 
authority to wage-adjust the cap amount.
    Final Decision: We are finalizing the update to the hospice cap 
amount for FY 2022 in accordance with statutorily-mandated requirements 
as well as the conforming regulation text changes at Sec.  418.309.

D. 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 the final 
rule that the addendum is intended to complement the Hospice Conditions 
of Participation (CoPs) at Sec.  418.52(c)(7) and (8), 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

[[Page 42546]]

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, 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 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 web page,\6\ 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 so 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)(1) 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 indicates 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.
---------------------------------------------------------------------------

    \6\ Hospice web page. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/index.
---------------------------------------------------------------------------

    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, in the FY 2022 proposed rule (86 FR 19724) we 
provided clarification on, and proposed modifications to, certain 
signature and timing requirements and proposed 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. In the FY 2022 hospice proposed rule, we noted that 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 (86 FR 19724). 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 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. We stated that 
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

[[Page 42547]]

providers are only able to discern what items, services, and drugs they 
will not cover once they have a beneficiary's comprehensive assessment. 
We proposed allowing 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, we acknowledged that 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). Obtaining 
the required signatures on the election statement has been a 
longstanding regulatory requirement. Therefore, we stated that 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, and we anticipate that hospices would use the same 
procedures for obtaining signatures on the addendum. We did note that 
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 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 proposed 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 proposed 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 indication of agreement with 
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, and noted 
that we would consider whether this issue would require future 
rulemaking. In the proposed rule, we stated that we have subsequently 
received this question from stakeholders post implementation, and 
therefore, clarified 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. We stated that 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 (86 FR 
19725).
    We also noted that 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. We reiterated that 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. We stated that 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 (86 FR 19725). As such, 
we proposed 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.
    We also discussed that 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 (86 FR 
19725). 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 
proposed conforming regulations text changes at Sec.  418.24(c) to 
reflect this policy. Furthermore, we proposed to clarify at Sec.  
418.24(d)(4) that if the patient dies, revokes election, 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 proposed 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 stated that 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 (86 FR 19725).
    Finally, we proposed 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. We proposed that 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

[[Page 42548]]

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''.
    Thirty-one unique stakeholders submitted their comments on the 
proposed clarifications to the election statement addendum. A few 
commenters requested additional clarification on certain topics and 
offered recommendations for the election statement addendum. These 
comments along with our responses are summarized below.
    Comment: The majority of commenters supported the clarifications 
and proposed regulation text changes regarding the election statement 
addendum. Commenters thanked CMS for these regulatory changes, stating 
that these clarifications will facilitate administration of the 
addendum and reduce hospice burden.
    Response: We thank commenters for their feedback.
    Comment: Some commenters recommended that the timeframe to furnish 
the addendum to the beneficiary (or representative) when requested 
after the first 5 days of a hospice election be changed from 3 days to 
5 days. Other commenters recommended that CMS change the requirement 
from 3 calendar days to 3 business days. One commenter requested 
clarification that the day of request is considered day zero. Another 
commenter mentioned that providing the addendum within 3 days is 
burdensome to beneficiaries (or representatives), because they felt 
pressured to meet with hospice staff to provide their signature for the 
requested addendum.
    Response: We did not propose to change the timeline for furnishing 
the addendum when a beneficiary requests the addendum during the course 
of a hospice election (that is, after the first five days of a hospice 
election date), and we continue to believe that 3 days is an adequate 
amount of time for the hospice to furnish the addendum. As we stated in 
the FY 2020 hospice final rule, because the hospice has already 
completed the comprehensive assessment and has begun providing care, we 
believe that this represents a sufficient timeframe for reviewing the 
patient record and completing the addendum if this information is 
requested during the course of hospice care (84 FR 38511).
    Additionally, as the plan of care should identify the conditions or 
symptoms that the hospice determines to be ``unrelated,'' this 
information should be readily accessible to the hospice in order to 
allow for the timely completion of the addendum. Hospices should update 
the addendum to include such conditions, items, services, and drugs 
they determine to be unrelated throughout the course of a hospice 
election. Hospices are able to create their own process when it comes 
to updating and providing the requested addendum to the beneficiary (or 
representative). Furthermore, we believe 3 calendar days, rather than 3 
business days continues to be appropriate, as hospice care is provided 
around the clock rather than only during business days and hours.
    In the proposed rule, we provided an example acknowledging the day 
of the request as day zero. We stated that when the request is within 5 
days from the date of a hospice election, and 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 (86 FR 
19724), making December 1st as day zero in this example. Moreover, 
because we proposed to change the timeframe requirements to correspond 
with the ``date furnished'' rather than the ``signature date,'' we 
disagree that this timeframe would be burdensome to beneficiaries. 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). Obtaining the required signatures on 
the election statement has been a longstanding regulatory requirement 
(84 FR 38484); however, we did acknowledge in the proposed rule that 
there may be time constraints and/or circumstances that would prevent a 
beneficiary from signing and returning the addendum to the hospice by a 
specified deadline. We proposed to require that the ``date furnished'' 
be within the required timeframe, rather than the signature date, to 
mitigate any undue strain on the beneficiary or representative in 
returning the addendum to the hospice by a specified date.
    Comment: Some commenters expressed concern that the request from a 
non-hospice provider for the election statement addendum does not 
require a signature. Commenters stated that hospices would have no 
proof that the addendum was provided to the non-hospice provider 
without the provider's signature.
    Response: If a non-hospice provider requests the addendum, the 
hospice must furnish the addendum, however, the non-hospice provider is 
not required to sign the addendum. We remind commenters that the intent 
of the addendum is to ensure that hospice beneficiaries and their 
representatives are fully informed of any items or services for which 
they must assume financial responsibility. Consequently, if only a non-
hospice provider or Medicare contractor request the addendum (and not 
the beneficiary or representative) CMS 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 a means of demonstrating 
that the addendum was furnished to a non-hospice provider and/or 
Medicare contractor upon request.
    Comment: A commenter asked CMS to define whether or not a mailed 
copy of the form would be acceptable. The commenter stated that they 
believe their patients and their representatives would welcome this 
option; however, it is unclear whether mailing the form is acceptable 
for CMS.
    Response: There is nothing precluding hospices from furnishing an 
addendum through mail. We expect that hospices would take steps in 
working with patients and their representatives to better understand 
which methods (that is, in person, mail, etc.) of delivery would work 
best in furnishing the addendum. Some beneficiaries or representatives 
may have time constraints that prevent them from signing and returning 
the addendum by a certain deadline, in which case, the date that the 
hospice furnishes the addendum to the beneficiary may differ from the 
date that the beneficiary (or representative) signs the addendum. 
Hospices would need to make sure the ``date furnished' on the addendum 
is within the required timeframe (3 or 5 days, depending upon when the 
request was made). Furthermore, we expect that hospices will have 
processes in place when they are obtaining a signed addendum from a 
beneficiary or representative.
    Comment: Many commenters requested making the proposed 
clarifications to the hospice election statement addendum retroactive 
to the implementation date of October 1, 2020. One commenter requested 
delaying the effective date of the proposed

[[Page 42549]]

clarification for the hospice election statement addendum to provide 
time for software updates in addition to reporting and system alerts.
    Response: We do not believe that making these clarifications 
retroactive or delaying the effective date is necessary. To date we 
have not received reports of claims denials resulting from the 
implementation of the election statement addendum and the current 
regulations at Sec.  418.24. Furthermore, many of these clarifying 
regulations text changes have been previously addressed in sub-
regulatory guidance. As such, the implementation of these 
clarifications on October 1, 2021 would not cause a burden for software 
updates.
    Comment: Many commenters encouraged CMS to update the model hospice 
election statement addendum on the CMS hospice center web page to 
illustrate these clarifications.
    Response: We will post an updated model election statement addendum 
on the Hospice web page,\7\ along with the publication of this FY 2022 
Hospice Wage Index and Payment Rate Update final rule. This is an 
illustrative example for hospices to modify and develop their own forms 
that meet the content requirements at Sec.  418.24.
---------------------------------------------------------------------------

    \7\ Hospice web page: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/index.
---------------------------------------------------------------------------

    Comment: Some commenters stated that it is redundant to require the 
hospice to note on the addendum and in the medical record the reason 
that a beneficiary did not provide their signature.
    Response: We recognize the commenters' concerns and agree that it 
is appropriate for the hospice to document only on the addendum itself 
the reason that an addendum is un-signed. This could include not only a 
beneficiary refusing to sign, but also death, discharge, or revocation 
prior to the hospice obtaining the signature. However, while a hospice 
can choose to document the reason for an unsigned addendum in the 
medical record, as well as on the addendum, it is not required.
    Comment: Many commenters offered suggestions regarding additional 
aspects of the election statement addendum for which we did not propose 
clarifying changes. Some commenters recommended that CMS align the late 
penalty for the addendum with the penalty for late submission of the 
NOE. Other commenters stated that denying the whole hospice claim when 
the addendum is furnished late is excessive. A commenter stated that as 
currently structured, the penalty is a negative incentive to furnish 
the addendum in a timely manner if a hospice misses the initial 
required timeframe. Some commenters mentioned there was confusion 
regarding billing when an addendum is furnished late. Other commenters 
recommended using a code to indicate billed but not covered hospice 
days when the addendum is furnished late. A few commenters stated they 
believe the addendum and the ABN have the potential to decrease 
transparency and increase confusion for hospice patients, whereas, 
other commenters recommended expanding the usage of the addendum, which 
included combining the ABN and addendum, and to include drugs or 
services which the hospice has determined to be medically unreasonable 
or no longer necessary. One commenter recommended that CMS explore ways 
to educate hospice providers about how they can inform their 
beneficiaries (or representative) when items, services, or drugs are 
considered related, but non-covered due to reasons such as not 
reasonable or necessary for the palliation and management of the 
terminal illness and related conditions. Moreover, a commenter 
recommended developing an exceptions process for when hospice providers 
are unable to provide an addendum because of `exceptional 
circumstances' that are beyond the control of the hospice. Lastly, one 
commenter suggested that since an electronically sent addendum could be 
tracked, a signature should not be required.
    Response: While these comments are out of scope of the proposed 
rule, we appreciate and welcome all feedback related to the late 
penalty; ABN and expansion of the addendum; signatures; exceptional 
circumstances; and educating hospice providers. While we did not 
propose any of these recommendations we could consider them for future 
rulemaking. We understand the possibility of conflating the differences 
between the ABN and the hospice election statement addendum. The ABN 
transfers potential financial liability to the Medicare beneficiary in 
certain instances, whereas the addendum (upon request) informs 
terminally ill beneficiaries (or their representative) only of items, 
services, or drugs the hospice will not be providing because the 
hospice has determined them to be unrelated to the terminal illness and 
related conditions. We refer readers to FY 2020 Hospice Wage Index and 
Payment Rate Update final rule (84 FR 38512) to learn more about the 
usage of the ABN. The hospice CoPs at Sec.  418.56(b) require hospices 
to educate each patient and their primary caregivers(s) on services 
identified on the plan of care and document the patient's (or 
representative's) level of understanding involvement and agreement with 
the plan of care. We expect that hospices would use the same methods 
when educating patients (or representatives) about the addendum and 
non-covered items, services and drugs, which the hospice has determined 
are not reasonable or necessary for the palliation and management of 
the terminal illness and related conditions.
    The hospice CoPs at Sec.  418.52(a)(1) require that in advance of 
receiving care, patients are informed about their rights, and hospices 
must provide the patient (or representative) with verbal and written 
notice of the patient's rights and responsibilities in a language and 
manner the patient understands. Likewise, the hospice CoPs at Sec.  
418.52(a)(3) requires that hospices obtain the patient's or 
representative's signature confirming that he or she has received a 
copy of the notice of rights and responsibilities. So, it is not 
unreasonable to require that the electronically sent addendum also be 
signed to ensure that the patient is aware of the important information 
about hospice non-covered items, services, and drugs. We do not have a 
policy for `exceptional circumstances' (that is floods, hurricanes, 
etc.) but we will consider addressing this policy in future rulemaking.
    Final Decision: We are finalizing the clarifications and addendum 
regulation text changes at Sec.  418.24(c) as proposed, with the 
exception of requiring the reason that the addendum is not signed to be 
documented in the patient's medical record. This explanation must be 
clearly noted on the addendum itself, but is not required to be 
documented in both places. Based on comments, we are amending the 
regulation text at Sec.  418.24 to state that if the beneficiary dies, 
revokes election, is discharged prior to signing the addendum, or 
refuses to sign the addendum, the addendum would not be required to be 
signed in order for the hospice to receive payment. The hospice must 
note (on the addendum itself) the reason the addendum was not signed 
and the addendum would become part of the patient's medical record. 
These changes will be effective on October 1, 2021.

[[Page 42550]]

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 changes and their 
respective histories and background information are discussed in the 
rule. We are also finalizing regulatory changes that are not directly 
related to PHE waivers that will clarify or align some policies that 
have been raised as concerns by stakeholders.
    We are finalizing the following revisions to the hospice 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, 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.
    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 are finalizing 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)). Additionally, we are finalizing definitions for 
both ``pseudo-patient'' and ``simulation'' at Sec.  418.3. Therefore, 
we are finalizing changes 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 final 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 changes will 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 Aide Training and Evaluation--Targeting Correction of 
Deficiencies
    We are also amending 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 change will 
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 and thus would 
require that those skills be included in the targeted competency 
evaluation.
    We received a total of 32 comments pertaining to the proposed 
revision to the CoPs. Commenters included individuals, hospice 
agencies, state hospice associations, national provider organizations, 
and patient advocacy groups. The response to those comments follows:
    Comment: Commenters were overwhelmingly supportive of the 
provisions to permit the use of pseudo-patients and simulation when 
conducting hospice aide competency training and for retraining of 
deficient skills. Several commenters indicated that the changes will 
facilitate a more time-efficient process in the evaluation of aide 
skills. Another commenter stated the changes improve the efficiency of 
onboarding new staff in a safe and effective manner.
    Response: We appreciate these comments and agree that the 
utilization of pseudo-patients and simulation will facilitate more 
timely completion of training requirements for newly hired hospice 
aides as well as allowing hospices to target specific competency 
training for hospice aides noted to have deficient skill(s) on the 
supervisory visit. We believe that this will benefit the hospice and 
the patient by allowing new aide trainees and aides requiring remedial 
training and competency testing to begin serving patients more quickly 
while protecting patient health and safety.
    Comment: Several commenters stated that the use of pseudo-patients 
and simulation techniques are common in healthcare and a standard of 
practice in many formal nursing assistant programs. These commenters 
also state that hospices can adequately assess an aide's skills through 
these means during competency training. Another commenter indicated 
that the use of pseudo-patients and simulation will support patient 
privacy.
    Response: We appreciate the commenters highlighting the use of 
pseudo-patients and simulation techniques in other healthcare setting 
and agree that the use of these techniques is standard of practice in 
many formal nursing assistant programs. We believe patient privacy is a 
fundamental right for those persons

[[Page 42551]]

receiving hospice care. We agree that permitting competency testing of 
hospice aides utilizing a pseudo-patient will support patient privacy 
while also assuring a competently trained hospice aide workforce that 
provide high quality patient care.
    Comment: While the majority of commenters supported the proposed 
changes; one commenter did not support the use of the pseudo-patient or 
targeted competency testing. The commenter suggested that more research 
and data are required on the use of pseudo-patients and changes to 
competency requirements prior to making a policy decision. The 
commenter also stated that data and research should support that using 
a non-patient in training is safe when aides subsequently provide care. 
Additionally, the commenter raised concerns regarding instances when 
multiple areas of deficient practice are noted and if a full competency 
would be done these instances.
    Response: We appreciate the commenter's concern and the request for 
additional research in this area. We believe, and other commenters 
noted, that the use of pseudo-patients and simulation is an accepted 
standard of practice for training in healthcare, including nurse aide 
training programs. These same requirements were implemented for home 
health aide supervision in 2019 (see 84 FR 51732 and the associated 
regulations at Sec.  484.80(c)(1)), without any reported adverse 
impacts noted to-date in CMS survey data or complaints being reported 
to CMS. Both the use of the pseudo-patient and targeted aide training 
align requirements between these two providers, home health and 
hospice, affording the opportunity for efficiency in implementation for 
many agencies that are Medicare certified to provide both services.
    When deficient aide skills are noted during a supervisory visit, 
the RN determines the deficient skills and all related skills that may 
be impacted. The supervising RN then determines the scope of the 
competency testing required, which may include a full competency 
testing of all skills if warranted, such as when multiple areas of 
deficient practice are noted.
    Comment: One commenter recommended CMS broaden its view of nurses 
to include licensed practical nurses (LPNs) for conducting aide 
supervisory visits. The commenter indicated that this change would 
provide greater staffing flexibility for hospices given workforce 
shortages among essential workers.
    Response: We appreciate the recommendation to permit greater 
flexibility for hospices in regards to staffing of essential workers. 
However, we have previously addressed this matter in prior rulemaking 
(see Medicare and Medicaid Programs: Hospice Conditions of 
Participation; final rule; 73 FR 32131 issued June 5, 2008) and believe 
the rationale for requiring a RN for conducting supervisory visits 
continues to be warranted. Registered nurses, through their education, 
training, and role in provision of hospice care, are best positioned to 
assess the adequacy of the aide services in relationship to the needs 
of the patient and family to a greater degree than LPNs, or licensed 
vocational nurses (LVNs). Ideally, the supervising RN is both 
responsible for supervision of the aide services as well as being 
primarily responsible for the patient's nursing care. This allows the 
RN to develop a complete picture of the patient and family and of the 
aide's services.
    Comment: Many commenters stated that focusing the competency 
training on specific deficient skills provided greater efficiency for 
hospices. One commenter indicated that comprehensive competency testing 
can take up to a full 8-hour day and a targeted approach will save time 
related to this requirement. Another commenter stated that completing a 
full competency test takes the focus away from the identified 
deficiency and is not effective. A third commenter stated that topic-
specific evaluations will significantly reduce time and allow hospices 
to concentrate on the specific deficient skills with additional 
practice and training.
    Response: We appreciate the support for this comment and agree that 
a targeted approach is both more efficient and will permit greater 
focus on remediating the deficient skills.
    Comment: Many commenters requested clarification related to the use 
of technology under the Medicare hospice benefit during the PHE. These 
commenters requested that CMS further clarify that technology-based 
visits are permissible outside of a PHE under the same circumstances 
and conditions as under a PHE, provided applicable HIPAA requirements 
are met, and requested that CMS establish modifiers that can be used on 
claims to designate such visits.
    Response: While comments on this topic are out of scope for this 
rulemaking, we do believe the subject is important to address, given 
the number of comments on this topic. On April 6, 2020, we published an 
interim final rule ``Medicare and Medicaid Programs; Policy and 
Regulatory Revisions in Response to the COVID-19 Public Health 
Emergency'' (85 FR 19230). This rule provided individuals and entities 
that provide services to Medicare beneficiaries needed flexibilities to 
respond effectively to the serious public health threats posed by the 
spread of COVID-19. The rule implemented temporary changes to the 
hospice payment requirements to provide broad flexibilities to furnish 
services using telecommunications technology in order to avoid exposure 
risks to health care providers, patients, and the community during the 
PHE. These changes will expire at the end of the COVID-19 PHE. The use 
of telehealth for conducting the required hospice face-to-face (F2F) 
encounter is statutorily limited to the PHE for COVID-19 in accordance 
with section 1814(a)(1)(7)(D)(i) of the Act, as amended by section 3706 
of the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-
136).
    The CoPs are not relevant to payment questions regarding the use of 
technology, such as telehealth, in the provision of hospice services. 
The standard of practice for hospice is that care and services are 
provided on an in-person basis based on needs identified in the 
comprehensive assessment and services ordered by the IDG and outlined 
in the plan of care. While nothing in the COPs prevent hospices from 
augmenting in-person visits with technological means, such as 
telehealth, these are not intended to change the standard of practice 
or replace in-person visits. Additionally, for the duration of the PHE, 
we expect that it would be up to the clinical judgment of hospice as to 
whether such technology can meet the patient's/caregiver's/family's 
needs and the use of technology should be included on the plan of care 
for the patient and family.
    We will continue to evaluate the impact of the COVID-19 PHE. At 
this point, we are still assessing the impact of all waivers and 
flexibilities on beneficiaries and the delivery of healthcare services 
under the PHE. While the impact of some waiver and flexibilities may be 
more apparent at this time, such as the waivers related to hospice aide 
supervision, flexibilities associated with other aspects of care are 
more complex requiring additional time for a complete understanding of 
their impact. We will continue to evaluate the flexibilities to 
determine if additional changes are warranted in the future.
    Final Rule Action: We are finalizing as proposed at Sec.  
418.76(c)(1) our policy that hospices may conduct competency testing by 
observing an aide's

[[Page 42552]]

performance of the task with a patient or pseudo-patient. Additionally, 
we are finalizing as proposed at Sec.  418.3 the definitions of 
``pseudo-patient'' and ``simulation''.
    We are also finalizing as proposed 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).

F. 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. We noted this revised statutory requirement 
in our proposed rule (86 FR 19726) and are codifying the revision at 
Sec.  418.306(b)(2).
    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 a 
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 regarding 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 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 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. 
We are revising the regulations text at Sec.  418.306(b)(2) under a 
``good cause'' waiver of proposed rulemaking as this change was noted 
in the proposed rule and is a statutory requirement of the CAA of 2021. 
Under the Administrative Procedure Act (APA) (5 U.S.C. 553), the agency 
is not required to conduct notice and comment rulemaking for a change 
that is statutory. Section V. of this final rule further details this 
waiver of proposed rulemaking. Thus, 42 CFR 418.306(b)(2) has been 
revised to follow the CAA of 2021 updates for the survey agencies.
    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 6. 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. Beginning no earlier than May 
2022, the Hospice Visits in Last Days of Life measure and the Hospice 
Care Index will also be publicly reported on the CMS website. Table 6 
lists all quality measures planned for FY 2022 for HQRP.

[[Page 42553]]

[GRAPHIC] [TIFF OMITTED] TR04AU21.143

    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 6. 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

[[Page 42554]]

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 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.
    We received comments from various stakeholders on the proposals and 
updates including a consumer advocacy group, health care providers, 
hospice provider organizations, hospice trade groups, including those 
focused on rural providers, consultants, EHR vendors, and MedPAC.
    Comment: We received a comment that we are making many updates in 
this rule and the resources for them are significant, especially during 
the COVID-19 Public Health Emergency (PHE). They ask us to consider a 
more gradual transition to new quality initiatives, staggered and 
prioritized.
    Response: We are mindful of the burden related to our updates. We 
purposely made no updates or proposals in the FY 2021 final rule during 
the COVID-19 PHE. For FY 2022, two of the four measures we proposed to 
add were claims-based measures which do not increase burden to 
providers. We also proposed to remove multiple measures thus leading to 
a net decrease of total measures. Under our proposal, the HQRP will go 
from 10 measures down to 4 measures with two of these measures being 
claims-based measures, and the two already publicly reported measures 
of the CAHPS Hospice Survey and NQF #3235, the HIS-Comprehensive 
Assessment Measure. The public reporting has been thoughtfully 
considered as discussed in this rule so that providers can access their 
data earlier and prepare for public reporting in FY 2022, no sooner 
than May 2022. We also consider this work in coordination with planned 
future HOPE implementation and ensuring that the HQRP now covers the 
entire hospice stay with these 4 measures rather than just admission 
and discharge.
2. Removal of 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 HIS Comprehensive

[[Page 42555]]

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 is not necessary.
    The interdisciplinary, holistic scope of the 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 \8\ 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.
---------------------------------------------------------------------------

    \8\ 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.
---------------------------------------------------------------------------

    In addition, MedPAC's Report to Congress: Medicare Payment Policy 
\9\ in recent years noted 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 assess the extent to which a hospice follows care processes. In this 
final rule, we are not making any revisions to the HIS Comprehensive 
Assessment Measure because the single measure continues to show 
sufficient variability and therefore provides value to patients, their 
families, and providers.
---------------------------------------------------------------------------

    \9\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
---------------------------------------------------------------------------

    Because the HIS Comprehensive Assessment Measure is a more broadly 
applicable measure, we are finalizing our proposal 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 proposed and finalize in this rule to remove the 
``7 measures that make up the HIS Comprehensive Assessment Measure'' 
section of Care Compare, which displays the seven HIS measures. We 
proposed and are finalizing these changes to remove the seven HIS 
process measures as individual measures from HQRP no earlier than May 
2022.
    Although we would remove the seven individual HIS process measures, 
it does not change 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 solicited 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 sought public comment on the 
technical correction to the regulation at Sec.  418.312(b) effective 
October 1, 2021.
    We received several comments on the proposal to remove the seven 
``Hospice Item Set process measures'' from the HQRP beginning FY 2022. 
A summary of the comments and our responses to those comments appears 
below:
    Comment: The majority of commenters supported the removal of the 
seven HIS process measures. Several commenters opposed removing the 
seven HIS process measures, at least prior to implementation of HOPE. 
These commenters believed that the existing process measures provide 
more valuable and transparent information about hospice performance 
than the HIS Comprehensive Assessment composite measure. Finally, some 
commenters recommended both removing the seven individual HIS process 
measures and retiring the HIS Comprehensive Assessment measure. These 
commenters suggested that retiring the composite measure would reduce 
provider burden.
    Response: We appreciate the support for this proposal. In response 
to the concerns raised by those opposing the removal of seven HIS 
process measures, we would like to emphasize that all but one of the 
seven HIS measures are topped out individually and one HIS measure is 
almost topped out and shows insignificant variability between hospices. 
The 7 HIS measures credited hospices when any of these measures were 
performed regardless of the individual patient. In contrast, the HIS 
Comprehensive Assessment Measure measures whether a hospice assesses 
each patient on the 7 HIS measures. This distinction is important since 
it explains why the individual HIS

[[Page 42556]]

measures can be topped out but when measured together as a group, or 
composite, that is required on each patient in order to get credit for 
the measure, the HIS Comprehensive Assessment Measure shows variability 
and meets public reporting standards. This distinction explains why 
most hospices receive the maximum possible score on each of the 7 HIS 
measures, but not on the HIS Comprehensive Assessment Measure. As such, 
the individual measures have a limited ability to differentiate 
hospices. In contrast, the HIS Comprehensive Assessment Measure shows 
that hospices need to improve on providing a comprehensive set of 
assessments on each patient at admission and supports why it continues 
to be a useful HQRP measure.
    While we consider it a success that hospices are assessing the care 
processes included in the 7 HIS measures, hospices have improved since 
2014 to the point that these 7 individual HIS measures no longer 
differentiate quality of care between hospices and need to be retired 
as individual quality measures and thereby removed from the HQRP. Now 
that we reached that milestone, we need to recognize that there is a 
need to focus on assessing the 7 HIS measures to each patient at 
admission, which is what the HIS Comprehensive Assessment Measure 
addresses. It more closely aligns with the intent of the Hospice CoPs 
at Title 42 Part 418.54 that require a comprehensive assessment on each 
patient. This is why the HIS Comprehensive Assessment Measure provides 
valuable and transparent information about hospice performance. 
Patients electing to receive hospice services should expect quality 
care and a comprehensive assessment of their needs at admission, which 
the HIS Comprehensive Assessment Measure reflects. While the transition 
from the HIS to HOPE will eventually enable the HQRP to be more robust, 
we should not wait to seek improvement on this composite measure as an 
indicator of quality. This supports why we must remove the 7 HIS 
measures now in favor of the one more meaningful measure.
    Finally, we support minimizing provider burden while maintaining 
quality measures that provide valuable information to providers and 
consumers about hospice quality. The variability shown in the HIS 
Comprehensive Assessment measure continues to provide useful 
information that allows patients and families to differentiate hospices 
and help select the best providers for their care.
    Comment: MedPAC recommended that CMS consider removing the HIS 
Comprehensive Assessment Measure because the scores suggest the 
composite measure is limited in distinguishing provider quality. The 
comment suggested that the HIS Comprehensive Assessment measure would 
be likely to top out due to high scoring trends among hospices.
    Response: We appreciate MedPAC raising this concern. We recognize 
that the HIS Comprehensive Assessment Measure reflects high scores and 
is improving over time, which may cause the measure to also become 
topped out in the future.\10\ However, we believe that the single 
measure currently continues to show sufficient variability to 
differentiate hospices and therefore provides value to patients, their 
families, and providers. Further, the HIS Comprehensive Assessment 
Measure reflects the Hospice CoPs for comprehensive assessments 
performed at admission, which is a critical time to determine the plan 
of care. Its removal would not only leave HQRP without this important 
admission quality of care measure but also result in HQRP having only 
two claims-based measures, HCI and HVLDL, and the CAHPS Hospice Survey. 
It is these four quality measures, the HIS Comprehensive Assessment 
Measure, HCI, HVLDL, and CAHPS Hospice Survey that make up the FY 2022 
HQRP requirements. These four measures cover hospice care throughout 
the hospice stay. The HIS Comprehensive Assessment Measure covers care 
at admission. HCI covers care throughout the hospice stay. HVLDL covers 
care during discharge and the CAHPS Hospice Survey covers the caregiver 
experience of hospice care. They complement each other and further 
support the need for each measure in the HQRP. We will continue to 
monitor the HIS Comprehensive Assessment Measure performance and 
consider if removal or refinements would be appropriate in the future.
---------------------------------------------------------------------------

    \10\ MedPAC. (2020). Chapter 11: Hospice Services. http://www.medpac.gov/docs/default-source/reports/mar21_medpac_report_to_the_congress_sec.pdf?sfvrsn=0.
---------------------------------------------------------------------------

    Final Decision: In this final rule, we are not making any revisions 
to the HIS Comprehensive Assessment Measure. We are finalizing our 
proposal 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 will remove the ``7 
measures that make up the HIS Comprehensive Assessment Measure'' 
section of Care Compare, which displays the seven HIS measures. These 
will be effective no earlier than May 2022. Hospice providers, must 
report HIS data used for the HIS Comprehensive Assessment Measure, in 
order to meet the requirements for compliance with the HQRP.
3. Addition of a ``Claims-Based Index Measure'', the Hospice Care Index
    We proposed the addition of a new hospice quality measure, called 
the Hospice Care Index (HCI), to HQRP. The HCI 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, will add new information 
to HQRP that was either directly recommended for CMS to publicly report 
by Federal stakeholders 11 12 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 \13\ 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. 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 8 illustrates how points are awarded based on 
meeting the criterion of the indicator. For example, Gaps in Skilled 
Nursing Visits have a criterion of ``lower than the 90th percentile,'' 
and supports the hospice CoPs that require an assessment of the patient 
and caregiver needs as well as

[[Page 42557]]

implementation of the plans of care. Other indicators, such as nurse 
visits (RN and LPN) 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.
---------------------------------------------------------------------------

    \11\ 2019: Vulnerabilities in Hospice Care (Office of the 
Inspector General).
    \12\ Report to Congress: Medicare Payment Policy (March 2019) 
MEDPAC.
    \13\ 2019: Vulnerabilities in Hospice Care (Office of the 
Inspector General).
---------------------------------------------------------------------------

    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 possible score. The ten indicators, aggregated into a 
single HCI score, convey a broad overview of the quality of the 
provision of hospice care services and validates well with CAHPS 
Willingness to Recommend and Rating of this Hospice. Skilled nursing 
visit data for indicators 2, 8, and 9 (described below) uses revenue 
center code 055X, which includes both RN and LPN visits for consistency 
with other indications for HCI.
    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 choose 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 while supporting their selection of hospice care 
providers. As a claims-based measure, the HCI measure will not impose 
any requirements for collection of new information. 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. 
The initiative helps guide our efforts to develop and implement quality 
measures to fill those gaps and develop those concepts towards quality 
measures that meet the standards for public reporting. The goal of HQRP 
quality measure development is to identify measures from a variety of 
data sources that provide a window into hospice care services 
throughout the dying process, fit well with the hospice business model, 
and meet the objectives of the Meaningful Measures initiative.
    To that end, the HCI will 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 HHS Office of 
Inspector General (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 of 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 eliminates 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 the actual 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.
    CMS already publicly reports several pieces of information derived 
from hospice claims data in the HQRP on Care Compare, including (i) the 
levels of care provided by the hospice, (ii) the primary diagnoses of 
patients served by the hospice, (iii) the location of hospice service 
provided, and (iv) the hospice's average 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

[[Page 42558]]

multiple claims-based indicators considered simultaneously. Therefore, 
the result 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 specifications based on simulated reporting 
periods.
b. Specifications for the HCI Indicators Selected
    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 proposed, 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 7 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 \14\ within a FY. The table reports the sample size before 
and after exclusion.\15\
---------------------------------------------------------------------------

    \14\ We count discharges as any claim with a discharge status 
code other than ``30'' (which is defined as ``Still Patient'').
    \15\ 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.
[GRAPHIC] [TIFF OMITTED] TR04AU21.144

    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.16 17 However, a 2013 
OIG report \18\ 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

[[Page 42559]]

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).
---------------------------------------------------------------------------

    \16\ 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.
    \17\ 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.
    \18\ 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 Skilled Nursing Visits
    The OIG has found instances of infrequent visits by nurses to 
hospice patients.\19\ To assess patients' receipt of nurse visits as 
outlined in the plan of care, one HCI indicator examines hospices that 
have a high rate of patients who are not seen at least once a week by 
nursing staff. This indicator includes both RN and LPN visits to 
recognize the frequency of skilled nursing visits and to maintain 
consistency in HCI when using revenue center code 055X.
---------------------------------------------------------------------------

    \19\ 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.\20\ 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:
---------------------------------------------------------------------------

    \20\ 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.
    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 skilled nursing 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 Skilled Nursing 
Visits, are as follows:
     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 skilled 
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.\21\ As MedPAC 
noted,\22\ ``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.''
---------------------------------------------------------------------------

    \21\ 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.
    \22\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
---------------------------------------------------------------------------

    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: \23\
---------------------------------------------------------------------------

    \23\ 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

[[Page 42560]]

hospice.\24\ 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).
---------------------------------------------------------------------------

    \24\ 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''.\25\ Because of quality implications for hospices who pursue 
such business models, the live discharge after long hospice enrollments 
was included in the index.
---------------------------------------------------------------------------

    \25\ 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.\26\
---------------------------------------------------------------------------

    \26\ 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.
---------------------------------------------------------------------------

    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.\27\ 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.
---------------------------------------------------------------------------

    \27\ For example, if the hospice discharge occurred on a Sunday, 
the hospitalization had to occur on Sunday, Monday, or Tuesday to be 
counted.
---------------------------------------------------------------------------

    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.\28\
---------------------------------------------------------------------------

    \28\ 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.
---------------------------------------------------------------------------

    This indicator identifies whether a hospice is below the 90th 
percentile in terms of the percentage of live

[[Page 42561]]

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) 
\29\ 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 hospices selectively enroll patients with non-cancer diagnoses 
and longer predicted lengths of stay in hospice.\30\ 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.\31\ 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.
---------------------------------------------------------------------------

    \29\ 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.
    \30\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
    \31\ 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:
     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: Skilled Nursing 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.\32\ 
Nursing services require initial and ongoing assessment of patient 
family needs to ensure the successful preparation, implementation, and 
refinements for the plan of care. This also includes patient and 
caregiver education and training as appropriate to their 
responsibilities for the care and services identified in the plan of 
care. This indicator includes both RN and LPN visits to recognize the 
frequency of skilled nursing visits and to maintain consistency in HCI 
when using revenue center code 055X.
---------------------------------------------------------------------------

    \32\ 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).
---------------------------------------------------------------------------

    This indicator identifies whether a hospice is above the 10th 
percentile in terms of the average number of skilled 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 skilled 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, Skilled 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 Skilled 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''.\33\ Fewer 
observed hospice

[[Page 42562]]

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. This indicator includes both RN and LPN visits to recognize the 
frequency of skilled nursing visits and to maintain consistency in HCI 
when using revenue center code 055X.
---------------------------------------------------------------------------

    \33\ 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).
---------------------------------------------------------------------------

    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 skilled 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 hospice team and drawing increasingly on hospice team 
resources.34 35 36 Physical symptoms of actively dying can 
often be identified within three days of death in some patients.\37\
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    \34\ 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.
    \35\ 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.
    \36\ 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.
    \37\ 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 RN, LPN, 
and/or medical social services visit in the last 3 days of life. For 
this indicator, we first 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 skilled 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 skilled 
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 skilled 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. In the proposed rule, the denominator 
description is discussed accurately, as the number of beneficiaries 
with at least one day of hospice during the last three days of life 
within a reporting period. However, the specification summary 
inaccurately reflected the number of decedent beneficiaries served by 
the hospice within a reporting period. In this final rule, we correct 
this error and replace the description of the denominator accurately as 
the number of beneficiaries with at least 1 day of hospice during the 
last 3 days of life within a reporting period.
    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 for the hospice in the last 
3 days of the beneficiary's life within a reporting period.
     Denominator: The number of beneficiaries with at least 1 
day of hospice during the last 3 days of life 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 worker 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 received, 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 for the ten 
performance indicators detailed earlier, 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 8 
illustrates how a hypothetical hospice's score is determined across all 
ten indicators, and how the ten indicators' scores determine the 
overall HCI score.
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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 1.
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    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. 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 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 supported 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 the 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

[[Page 42565]]

needs or the full array of hospice 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 
adopting the HCI outweigh its limitations. The HCI is not intended to 
account for all potentially valuable aspects of hospice care, nor is it 
expected to entirely close the information gaps presently found in the 
HQRP. Rather, the HCI will 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 proposed and 
finalizing in the rule to begin reporting this measure using existing 
data items no earlier than May 2022. For more details, see section (3). 
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 its 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 solicited public comment on the proposal to add the composite 
HCI measure to the HQRP starting in FY 2022. We also solicited comments 
on the proposal to add the HCI to the program for public reporting 
beginning no earlier than May 2022. We received many comments on these 
proposals. A summary of the comments we received regarding HCI and our 
responses to those comments appear below:
    Comment: Several commenters expressed the importance of HCI for 
beneficiary and families that will give them information about care 
processes and add value to the available information about hospices 
that identifies aberrant practice when comparing hospices.
    Response: We appreciate the support by comments recognizing the 
value HCI brings to consumers by providing more information not 
previously available about hospices. The HCI will add value to the HQRP 
by filling measurement gaps using existing data sources.
    Comment: Many commenters appreciate the need for CMS to address 
program integrity or identify hospices with aberrant practices, and 
encouraged CMS to develop different measures that better reflect the 
holistic, interdisciplinary nature of hospice. Other comments also 
suggested that data already provided in PEPPER reports should not be 
included in HCI or that CMS should share the indicators in the PEPPER 
reports rather than implement the HCI quality measure to provide 
hospices the opportunity to implement continuous quality improvement 
activities.
    Response: We recognize commenters' concern that HQRP measures 
reflect quality of care rather than program integrity issues. We 
believe HCI does reflect hospice quality because the HCI indicators 
were identified as quality issues by the Office of Inspector 
General,\38,39,40\ the Medicare Payment Advisory 
Commission,41 42 43 by peer reviewed articles, and our 
technical expert panel (TEP). Further, HCI like the other HQRP quality 
measures validates well with the CAHPS Hospice Survey ``willingness to 
recommend'', which signifies a quality measure useful for public 
reporting.
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    \38\ Department of Health and Human Services, Office of 
Inspector General. (2013). Medicare hospice: Use of general 
inpatient care. Accessible via: https://oig.hhs.gov/oei/reports/oei-02-10-00490.asp.
    \39\ Department of Health and Human Services, Office of 
Inspector General. (2016). Medicare hospice: Hospices 
Inappropriately Billed Medicare Over $250 Million for General 
Inpatient Care. Accessible via: https://oig.hhs.gov/oei/reports/oei-02-10-00491.asp.
    \40\ Department of Health and Human Services, Office of 
Inspector General. (2019). Registered Nurses Did Not Always Visit 
Medicare Beneficiaries Homes at Least Once Every 14 Days to Assess 
the Quality of Care and Services Provided by Hospice Aides. 
Accessible via: https://oig.hhs.gov/oas/reports/region9/91803022.pdf.
    \41\ Medicare Payment Advisory Commission. March 2009 Report to 
the Congress: Medicare Payment Policy, ``Chapter 6: Reforming 
Medicare's hospice benefit.'' February 27, 2009. Accessible via: 
http://www.medpac.gov/docs/default-source/reports/Mar09_Ch06.pdf?sfvrsn=0.
    \42\ Medicare Payment Advisory Commission. March 2011 Report to 
the Congress: Medicare Payment Policy, ``Chapter 11: Hospice.'' 
March 15, 2011. Accessible via: http://www.medpac.gov/docs/default-source/reports/Mar11_Ch11.pdf?sfvrsn=0.
    \43\ Medicare Payment Advisory Commission. March 2020 Report to 
the Congress: Medicare Payment Policy Text, ``Chapter 12: Hospice 
Services.'' March 13, 2020. Accessible via: http://www.medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf?sfvrsn=0.
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    We also appreciate the suggestions to include HCI indicators in 
PEPPER reports rather than implement HCI. However, unlike PEPPER 
reports that are issued to hospices to support their compliance efforts 
related to potential improper payments, as part of the HQRP, the HCI 
will become information on Care Compare that beneficiaries, caregivers, 
or other stakeholders may consider as they make choices about end-of-
life care.
    Comment: Several comments suggested that CMS differentiate 
circumstances in which a patient refused a service measured by the HCI 
from circumstances in which the hospice did not offer the service to 
the patient. Other comments highlighted the possible impact of claims-
based measures on rural and small providers because they may not 
capture care in rural communities or possibly identified as an outlier 
due to low volume.
    Response: CMS acknowledges that patients have the right to refuse 
hospice services, and that some refusals are expected and appropriate. 
CMS expects hospices to honor patient wishes on a case-by-case basis. 
Thus, we do not anticipate service refusals to be concentrated among 
particular hospices, and as such do not expect refused visits to have 
an outsized effect on any hospice's performance on this measure. 
Several existing measures, such as the HIS-based HVWDII measure and its 
replacement HVLDL, also do not differentiate refused visits.
    We also appreciate the comments expressing concern about the impact 
these measures may have on small and/

[[Page 42566]]

or rural hospices. We recognize that there are many regional variations 
in care delivery trends. We will monitor HCI score trends to identify 
whether any regional or size-based variations suggest a need for 
measure revision. However, population-based measures such as indicators 
on the HCI allow for hospice variation for an indicator while offering 
opportunities to earn points on other indicators. The points are earned 
without weighting to recognize the tradeoffs for each indicator's 
specifications.
    Comment: Several comments recommended that CMS not implement HCI 
because the indicators seem to emphasize medical services, focused 
heavily on services provided by RNs/LPNs, or do not account for the 
full interdisciplinary group (for example, claims do not account for 
spiritual care). Some commenters questioned whether services provided 
by LPNs would be accounted for in the HCI indicators and many 
commenters requested that CMS clarify whether code 055X would be 
further differentiated between RN visits versus LPN visits for the 
indicators.
    Response: We recognize that claims data do not include all the 
disciplines involved in the delivery of hospice care, such as the 
frequency and length of chaplain visits. While changing the data 
included in claims is outside the scope of this proposed measure, we 
believe that using the claims data that currently exists still provides 
new and useful information not currently available to patients, 
families, and caregivers with the existing HQRP measures. As we showed 
with the HVLDL claims-based measure, RN services correlate well with 
CAHPS data and therefore are important services to reflect hospice 
quality of care. The HCI serves as a useful step in addressing HQRP 
data gaps and providing useful information to consumers, even if it 
does not account for all potentially valuable data currently missing 
from HQRP. CMS will monitor data availability as well as measure 
performance, and may re-specify the measure if needed. If additional 
data points become available, CMS will consider modifying the measure 
in light of the new data. CMS' sub-regulatory Quality Measure Users' 
Manual on the CMS HQRP Current Measures web page will include 
specifications for each indicator and scoring for HVLDL, and the HIS 
Comprehensive Assessment measure (NQF #3235).
    We appreciate the comments and request for clarification on whether 
LPNs are included in visits. Both RN and LPN visits are included on the 
hospice claim under revenue code 055X and as such, the HCI does include 
LPN visits for the indicator for all indicators that use revenue code 
055X for consistency. This does not constitute a change to the 
requirements of the CoPs.
    Comment: Several commenters stated that the HCI should focus on 
whether hospices are prepared to provide key services, rather than 
whether claims for those services were billed during a given reporting 
period. One way to approach this would be to use state survey data to 
identify hospices that are deficient and do not have contracts to 
provide GIP. This information would provide additional context to the 
claims data of whether a hospice provided CHC or GIP.
    Response: We appreciate commenters' interest in having the HCI 
reflect how prepared hospices are to provide key services to patients. 
We believe that by measuring whether hospices actually provided CHC and 
GIP, the HCI will recognize the extent to which hospices both kept 
patients at home and recognized the need for inpatient care when 
necessary. In this way, these billing categories reflect actions taken 
to meet patients' needs during the reporting period. While we recognize 
the additional context that state survey data would provide, we believe 
the claims data used to calculate the HCI will provide valuable 
information to consumers on their own.
    Comment: We received several comments out of scope of the proposal 
suggesting CMS allow for use of the spiritual care HCPCS code approved 
for Veteran Administration use. Some commenters requested that CMS 
expand billing codes for telehealth visits and recognize telehealth 
services within the HCI. Other commenters expressed concern that the 
HCI indicators do not take patient preferences into account, and that 
the HCI might incentivize hospices to standardize the types and amount 
of services provided rather than considering personal patient 
circumstances.
    Response: We appreciate commenters' concerns that hospice providers 
continue to recognize and address the unique circumstances of hospice 
patients. At this time, the HCPCS code for spiritual care is not used 
on the hospice claim form (no revenue center exists to correspond to 
such code), and as such, cannot be applied to the HCI. Additionally, we 
did not propose to expand billing codes for telehealth services or 
patient preferences, and as such cannot include such services in the 
HCI. However, if additional Medicare hospice claims data points become 
available, we may consider modifying the measure in light of the new 
data. We are concerned hospices believe HCI may incentivize hospices to 
standardize the types or amount of services provided to patients and 
not individualize beneficiary care on a case-by-case basis at the end 
of life. CMS will continue to monitor for any aberrant behavior in 
regard to HCI and the care provided by hospices.
    Comment: Several commenters would like more time and information to 
replicate the analysis for HCI. The commenters suggest a delay in 
publicly reporting or no earlier than May 2022, which would to allow 
time for internal analysis.
    Response: We appreciate commenters' concerns that hospice providers 
do not believe they could replicate the indicators without more 
information. However, in the preamble of the FY 2022 Hospice proposed 
rule (86 FR 19700) and in this final rule is a description for each 
indicator including the rationale, numerator, denominator, exclusion 
criterion, and data sources. We believe the information provided in the 
proposed and final rule allows for commenters to replicate, with their 
own claims data, the indicators, thresholds, and points earned. The 
sub-regulatory Quality Measure Users' Manual will be posted on the HQRP 
Current Measures web page to provide measure specifications. We believe 
this information provides the detail needed, as with prior versions of 
the Quality Measure Users' Manual, to model and analyze HCI and its 
indicators. As discussed later in this section of the preamble, 
hospices will have access to preview reports in advance of publicly 
reporting HCI.
    Comment: Many commenters offered suggestions to modify specific HCI 
indicators and expressed concerns about specific indicators rather than 
the HCI as a whole. Several commenters suggested that CMS adjust the 
thresholds for specific services, such as gaps in skilled nursing 
visits, and phase in the thresholds over time. Some commenters 
questioned how well the HCI differentiates between high-quality, 
average, and low-quality hospices. They encouraged CMS to conduct 
further analyses before finalizing the measure.
    Response: We appreciate commenters' suggestions for modifications 
to the indicators, additional analyses to conduct, and requests to 
monitor the indicators. We also appreciate the concern that we avoid 
duplicating measures in the development of new measures based on 
assessment data, claims, or other available data sources. We conducted 
multiple analyses during the development of HCI to validate these 
indicators and determine

[[Page 42567]]

thresholds before selecting them for inclusion in the final HCI 
measure. We also shared the measure concept publicly and solicited 
stakeholder feedback, which we considered before finalizing the measure 
specifications. Our analyses showed that the HCI as currently defined 
does differentiate between hospices, as the range of HCI scores across 
hospices was found to be sufficiently large to highlight very high 
performing hospices, as well as identify the need for improvement in 
others. Additionally, the distribution of HCI scores aligns with 
caregivers' perceptions of hospice quality. As such, we have determined 
that the ten HCI indicators, taken together as currently defined, 
reflect a holistic view of hospice performance trends during a 
patient's stay.
    Comment: Several commenters expressed concerns that the HCI will 
overlap with, or be duplicative of, HOPE-based measures.
    Response: We appreciate commenters' concerns regarding the 
administrative burden in quality reporting. Because the HCI relies on 
claims data that are already collected by CMS, reporting claims-based 
measures places no additional burden for hospice providers or other 
stakeholders. In addition, the HCI and HOPE will complement each other, 
providing related but distinct information to providers and consumers 
to compare hospices.
    Comment: Some commenters expressed concern that the HCI will become 
``topped out,'' with 85 percent of hospices scoring a 7 or better, 
limiting the measure's ability to differentiate between hospices.
    Response: We appreciate commenters' concerns that HQRP measures 
will not be able to adequately differentiate hospices if they become 
``topped out.'' We also understand why commenters might expect process 
measures to be prone to ``topping out.'' CMS has taken this into 
consideration in designing the HCI measure. The design of the HCI 
ensures that the measure is very unlikely to become topped out. Each 
HCI indicator is scored based on comparative performance, with hospices 
receiving a point based on their performance relative to a national 
percentile threshold. Using percentile rankings derived from national 
performance, it is very unlikely for all hospices to receive the same 
score. Our analyses suggest that the scoring criteria ensure 
distributions of HCI scores that allow for differentiation between 
hospices in any given year. However, CMS will continue to monitor the 
HCI after implementation to ensure the measure reflects hospice 
quality, differentiates between hospices, and does not become topped 
out.
    Final Decision: We are finalizing the proposal to add composite HCI 
measures to the HQRP as of FY 2022 and will monitor the measure. As 
discussed later in this section of the preamble, we will publicly 
report 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 provided 
the HVLDL specifications and also proposed to replace the HVWDII 
measure pair with the HVLDL. This means that we will no longer report 
HVWDII with patient stays 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 requirements for the collection 
of information.
    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 \44\ 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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    \44\ 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.
    We received several comments regarding the updates to the Hospice 
Visits in the Last Days of Life (HVLDL) and Hospice Item Set V3.00. A 
summary of the comments we received and our responses those comments 
are below:
    Comment: Several comments support the re-specified HVLDL claims-
based measure and the resulting reduction of burden, but expressed 
concern that the measure is limited to RN and medical social worker. 
Commenters stated that the measure should recognize the full spectrum 
of disciplines involved in hospice care. Some commenters requested that 
LPNs count for the measure, in addition to RNs. Other commenters stated 
that chaplain or spiritual services may be as important to patients as 
nursing services.
    Response: As discussed in the CMS-10390 Supporting Statement 
published October, 23, 2020 and HIS V3.00 approved by OMB on February 
16, 2021, we pursed a re-specification of the HVWDII measure concept 
using Medicare claims data because claims data also capture RN and 
medical social worker visits by hospice. While CMS agrees that all 
patient visits are meaningful, based on our analyses, we found that RN 
and medical social worker visits correlate well with the CAHPS quality 
measures for ``would recommend'' the hospice. HVLDL indicates the 
hospice provider's proportion of patients who have received visits from 
an RN or medical social worker (in-person) on at least two out of the 
final three days of the patient's life. While all patient visits are 
meaningful, only patients with visits on two different days during the 
last three days of life will count towards the numerator for this 
measure. These visits can be made by either the RN, the medical social 
worker, or both. We were interested in re-specifying the visit measure 
to better align with the SIA because, as we discussed in previous 
rules, patient needs typically surge as

[[Page 42568]]

the end of life approaches and more intensive services are warranted. 
The provision of care would proportionately escalate to meet the 
increased clinical, emotional, and other needs of the patient and 
family.
    Comment: Some commenters stated that the measure specifications 
would not adequately capture hospices' care activities. Some commenters 
suggested that the measure should allow for two visits occurring on the 
same day to meet the measure qualifications, as visits on the same day 
could address different patient needs, representing meaningful care on 
the part of the hospice. Other commenters requested that this measure 
recognize visits offered during CHC or GIP care. Some commenters stated 
that the measure should recognize telehealth visits in the last days of 
life, as circumstances such as the recent COVID-19 PHE may make in-
person visits impossible or undesirable for patients or families.
    Response: We agree that hospice care is interdisciplinary care 
delivered by clinical and non-clinical staff supporting the patient's 
plan of care. We also support hospices providing necessary visits in 
the last days of life such that two visits occurring on the same day 
may be necessary. However, as discussed in the CMS-10390 Supporting 
Statement published October 23, 2020 and HIS V3.00 approved by OMB on 
February 16, 2021, our analysis comparing HVWDII and HVLDL with CAHPS 
``would recommend'' scores demonstrates that HVLDL results in higher 
validity and variability testing results compared to HVWDII. We found a 
stronger correlation coefficient with CAHPS ``would recommend'' scores 
for HVLDL than for HVWDII. This means that when visits by RNs or 
medical social workers occurred in at least two of the last three days 
of life, family and caregivers agree or positively correlate that they 
would recommend the hospice, more often when compared to HVWDII, on 
average. The literature strongly supported the focus on RNs and medical 
social workers in the revised measure.
    Actively dying is a critical and unique time when in-person, 
skilled care is typically needed. HVLDL is defined for in-person 
visits. As with all quality measures, we are encouraging quality of 
care and as such hospices are expected to use in-person visits when 
visits are needed during these critical last days of life. We agree 
there are benefits to telehealth visits that supplement, not replace, 
in-person visits. If claims data are revised to include other 
disciplines, we may consider whether to include them in this measure. 
This measure does not recognize visits during CHC and GIP because these 
higher levels of care inherently require skilled visits per the COPs in 
accordance with Sec.  418.110 and Sec.  418.302.
    Comment: Several comments requested that CMS clarify how ``the last 
three days of life'' would be calculated. Commenters expressed concern 
that definitions were unclear.
    Response: The exclusion criteria used for HVWDII and now HVLDL 
criteria remain the same. The calculation of the last three days remain 
unchanged from the last three days documented in Section O of the HIS 
V2.00 that was used to calculate the HVWDII. Information defining the 
last three days has been included in the HIS Manuals since 2017. These 
specifications will now be contained in the revised HQRP QM User's 
Manual V4.00 located on the CMS HQRP Current measures web page. This 
information was also posted in the document ``Common Questions HQRP 
Claims-Based Measures_Feb.2021'' located in the Downloads section of 
the Hospice Item Set web page at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.
    Specifically these three days are ``indicated by the day of death, 
the day prior to death, and two days prior to death.'' The day of death 
is the same as the date provided in A0270, Discharge Date. (or the day 
of death); One day prior to death is calculated as A0270 minus 1, and 
two days prior to death is calculated as A0270 minus 2. Full HVLDL 
specifications are also publicly available on the HQRP website at: 
https://www.cms.gov/files/document/hospice-visits-last-days-life-hvldl-measure-specifications.pdf.
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 
proposed and finalize in this rule the regulation at Sec.  418.312(b) 
by adding paragraphs (b)(1) through (3). Paragraph (b)(1) will 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) is 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:
    (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 did not receive comments on this proposal. We are finalizing in 
this rule 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),

[[Page 42569]]

we are developing a hospice patient assessment instrument identified as 
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. 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 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 HOPE will replace the HIS. While the HIS is a 
standardized mechanism for abstracting medical record data, it is not a 
patient assessment tool because HIS data are not collected during a 
patient assessment. 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, 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. 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. HOPE will include key items 
from the HIS and demographics like gender and race. This approach to 
include key aspects of 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 measure the care of 
patient populations across settings. While the standardized patient 
assessment data elements for certain post-acute care providers required 
under the IMPACT Act of 2014 is not applicable to hospices, it makes 
reasonable sense to include some of those standardized elements that 
appropriately and feasibly apply to hospice. Some patients may move 
through the healthcare system to hospice so capturing and tracking key 
demographic and social risk factor items that apply to hospice 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 of 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 HOPE 
in future rulemaking after testing is complete.
    We will continue development of HOPE in accordance with the 
Blueprint for the CMS Measures Management System. Development of 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 
listening sessions, expert interviews, key stakeholder interviews, and 
focus groups to support HOPE development. As CMS proceeds with field 
testing 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 HOPE and 
related quality measures. We also have a dedicated email account, 
[email protected], for comments about HOPE. We will use 
field test results to create a final version of HOPE to propose in 
future rulemaking for national implementation. We will continue to 
engage all stakeholders throughout this process. We appreciate the 
support for 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.
    We received many comments about the HOPE update. A summary of these 
comments and our responses appear below:
    Comments: Several commenters encouraged CMS to thoughtfully 
consider the implementation timeline for HOPE and the collection 
demographic and social risk factor data. The comments pointed out that 
the process for providers to adapt to the new tool requires at least 6 
months or more. They noted the implementation of a new assessment 
instrument would be burdensome on both providers and EMR vendors.
    Several commenters noted the potential for overlap in quality 
measures from HOPE and HCI or future measures. They encouraged CMS to 
eliminate any duplicative measures from HCI and HOPE, and to consider 
using HOPE data as the source for publicly reported information once it 
is implemented.
    Response: We thank commenters for raising points for CMS to 
consider in advance of HOPE implementation. We appreciate commenters' 
concern for provider and vendor burden in implementing a new tool and 
encourage all key stakeholders to continue to stay informed and engaged 
through the HQRP Forums, Quarterly Updates, and listserv notifications.
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 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 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 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 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

[[Page 42570]]

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. HOPE 
items assessing Symptom Impact, and Patient Desired Tolerance Level for 
Symptoms or Patient Preferences for Symptom Management were used to 
calculate this measure. 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 sought public comment on 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 later in this section of the 
preamble, 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 solicited 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 also solicited 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 cannot be calculated 
using claims data alone. Assessment data can be used to support risk-
adjustment. We sought public comment on quality measure concepts and 
considerations for developing hybrid measures based on a combination of 
data sources.
    We received many comments on future quality measure development 
aspects. A summary of these comment and our responses to those comments 
appear below:
    Comment: We received several comments suggesting concepts for 
future quality measures in the HQRP such as measures related to 
postmortem service, plan of care goal achievement, spiritual care, 
psychosocial care, veteran services, volunteer activities, visit 
activity at the time of admission, change of level of care, change of 
physical location, safety culture, and workforce engagement, and 
patient and family care needs. Comments urge CMS to monitor duplication 
of measures when HOPE-based and other future measures are under 
development. Many commenters emphasized the need to engage providers to 
share information and for CMS to seek feedback when developing quality 
measures.
    We received many comments expressing the need for HCPCS codes for 
all hospice disciplines, including spiritual care professionals. These 
comments also suggested including these disciplines in future claims-
based measures to recognize the multi-disciplinary nature of hospice 
care.
    Many commenters noted their concern about the distinction between 
performance measures and quality of care measures. Commenters 
emphasized that performance measures should be used to measure program 
integrity, but should not be publicly reported. Several commenters 
encouraged CMS to use quality claims-based data and other data sources 
for hybrid measure, consider the implications of claims-based measures 
to measure quality, use of survey data if feasible, explore outcome 
measures related to pain and other symptom management, and explore goal 
achievement. Several comments suggest CMS explore statewide or regional 
approaches to measure quality rather than using national analysis and 
perform rigorous data validation by hospice providers for claims-based 
measures.
    Response: We thank all the commenters for their thoughtful 
suggestions and feedback related to future of quality measure 
development for the HQRP. We appreciate suggestions for new quality 
measures, as well as comments about the public reporting of quality 
measures. CMS will take these comments under advisement for future 
consideration of quality measures and the Meaningful Measures System 
Blueprint. We encourage all key stakeholders to continue to stay 
informed and engaged through the HQRP Forums, Open Door Forums, 
Quarterly Updates, and listserv notifications.

[[Page 42571]]

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 
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,\45\ public reporting will 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 the 
COVID-19 PHE Exemptions
---------------------------------------------------------------------------

    \45\ https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
---------------------------------------------------------------------------

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. 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 9.
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[GRAPHIC] [TIFF OMITTED] TR04AU21.147

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 10 restates the data submission dates for FY 
2023 through FY 2025.

[[Page 42572]]

[GRAPHIC] [TIFF OMITTED] TR04AU21.148

BILLING CODE 4120-01-C
    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.
    In the proposed rule, we proposed 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 proposed 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 proposed 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 would be the average of the 
hospice-level scores for each item within the measure. Similar to other 
CAHPS programs, we proposed 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 proposed 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 proposed to 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 proposed that hospice star 
ratings for each measure be assigned based on where the hospice-level 
measure score falls within these cut-points.
    We further proposed 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 proposed 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. Finally, we proposed 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 solicited comments on these proposals for CAHPS Star Ratings and 
the public reporting of star ratings no sooner than FY 2022.

[[Page 42573]]

    Comment: Many commenters expressed concern about the timeframe for 
implementing CAHPS Hospice Survey star ratings. They suggested that the 
display of star ratings be delayed because CMS needs to provide 
additional opportunities for providers to learn about and comment on 
the details of the methodology. In addition, some commenters wanted CMS 
to consider creating a single star rating based on both CAHPS and other 
measures, such as the HOPE tool.
    Response: As stated in the proposed rule, we will display CAHPS 
Hospice Survey star ratings no sooner than FY 2022. Prior to finalizing 
a timeline, CMS will provide multiple opportunities to share 
information and receive comments from stakeholders. This could include 
a special open door forum or other venues for interaction. CMS proposed 
a CAHPS-only star rating since other portions of Care Compare also 
display a CAHPS-only star rating (for example, Hospital CAHPS and Home 
Health CAHPS). We will take the recommendation of a single star rating 
into consideration for the future.
    Comment: A few commenters requested specifically for an explanation 
for using top-box scoring of individual level responses for the star 
ratings. They note that other star ratings use a 0-100 linear-scaled 
score.
    Response: CMS analyzed existing data to inform the development of 
star ratings in the hospice setting. We examined star ratings using 
linear means and, separately, top-box scores. For CAHPS Hospice Survey 
data, using top-box scores resulted in wider star rating categories 
that make the star ratings less sensitive to small changes in scores. 
For this reason, we proposed to calculate CAHPS Hospice star ratings 
using top-box scores.
    Comment: Several commenters raised a concern regarding whether 
relatively high levels and tight distribution of performance on CAHPS 
Hospice Survey measures will result in hospices with high scores 
receiving 3 or fewer stars. Some commenters were concerned about the 
comparative nature of CAHPS star ratings and a few called for an 
alternative methodology that would rate hospices against a benchmark.
    Response: Our analyses of existing CAHPS Hospice Survey data 
demonstrate that hospices with high scores would overwhelmingly receive 
4 and 5 stars. Clustering methodology assigns cut points by minimizing 
differences within star categories and maximizing differences across 
star categories. This methodology does not force a set number of 
hospices into each star category. Using a benchmark rather than the 
clustering approach represents a major shift from our current practice. 
The current methodology has been successful for other provider types. 
We do not believe it is necessary to drastically change our methodology 
for the CAHPS Hospice Survey.
    Comment: Some commenters raised questions about using 75 completed 
surveys as the threshold for public reporting of stars. They were 
concerned that this number is nearly double the number of survey 
responses required from home health agencies (40 completes) and more 
than double the number of responses a hospice must currently have for 
CAHPS[supreg] Hospice Survey measures to be reported (30 completes). 
They requested a justification for using this number. One commenter 
stated that given the survey response rate, a hospice would have more 
than 200 completed surveys in order for star ratings to be displayed. 
This was a concern for many commenters because it would mean that star 
ratings would be available only for large hospices. Some commenters 
suggested that CMS formulate a methodology that would include smaller 
hospices in star ratings. Additionally, several commenters noted that 
the proposed rule does not state how many hospices will meet the 75 
completes threshold.
    Response: CMS seeks to balance the goal of reporting star ratings 
for as many hospices as possible with the need to ensure that the star 
ratings can be stably estimated and distinguish between hospices' 
performance. If a hospice does not have enough survey completes to 
reliably measure performance, the star ratings would be picking up more 
noise than true performance. Our analyses have determined that the 
optimal balance between these two goals is at 75 completed surveys per 
hospice. We expect that approximately 70 percent of hospices with 
publicly reported CAHPS Hospice Survey measure scores meet the 
threshold of 75 completed surveys.
    Comment: Several commenters expressed concerns that the public will 
not interpret the star ratings correctly. They also called for more 
explanatory information on the Care Compare website.
    Response: The star rating approach proposed for CAHPS Hospice 
Survey measures is similar to what has been used for Medicare Advantage 
and Part D plan measures and Hospital CAHPS measures successfully for 
many years. These other settings utilize a clustering algorithm such 
that providers within a cluster are more alike than providers across 
clusters. The proposed CAHPS Hospice Survey stars will adopt a similar 
overall approach, although using top-box scores rather than linear 
means, based on our analyses of existing data. Consumers have generally 
welcomed star ratings. We will make explanatory information available 
to consumers, while recognizing that keeping the interface as 
streamlined as possible improves the usability of the site for 
consumers.
    Comment: Several commenters stated concerns that the public might 
misinterpret the lack of star ratings for smaller hospices as being 
evidence of poor quality care. They called for customer research on how 
the public would interpret the absence of star ratings as well as 
research on the extent to which the public understands how star ratings 
are calculated.
    Response: Star Ratings are easy for consumers to understand and 
interpret and are used in a variety of settings. We will explore 
alternatives for presenting additional information about star ratings 
on the Care Compare website so that consumers may be informed about why 
smaller hospices may not have stars.
    Comment: A few commenters requested more details about if and how 
we will include patient-mix adjustment.
    Response: Star ratings are based on CAHPS Hospice Survey measure 
scores, which are adjusted for case mix and mode of survey 
administration. Detailed information regarding adjustment of measure 
scores is available at https://hospicecahpssurvey.org/en/scoring-and-analysis/.
    Comment: Several commenters raised issues about the eight quarters 
of data included in public reporting. They believe that this is too 
long and that it makes it difficult for hospices to use publicly-
reported data for quality improvement.
    Response: CMS seeks to balance the goal of publicly reporting 
measure scores for as many hospices as possible with the need to ensure 
that measure scores can be stably estimated and distinguish between 
hospices' performance. Rolling up eight quarters of data instead of 
four ensures that measure scores are available for many more hospices, 
which improves the usefulness of the Compare web tools for hospice 
consumers. The eight quarter approach does not result in a delay of 
when data become available (since the most recent quarters of data are 
included in the rolled-up score), but it does ensure more accurate 
measurement. The decision to use eight quarters of rolling data for 
hospices reflects the size of hospices, which differ in size and other 
dimensions from other types of entities, such as hospitals and Medicare 
Advantage contracts, for

[[Page 42574]]

which CMS publicly reports scores and star ratings. We note that 
hospices should be able to receive timely reports and data directly 
from their survey vendors. We encourage hospices who want to use CAHPS 
data for quality improvement to talk to their vendors about the reports 
and data that may be available shortly after data collection.
    Comment: A commenter stated that the preview report timeframe is 
too short and that hospices should receive preview data at least 1 year 
prior to its publication in order to analyze performance and implement 
quality improvement.
    Response: As stated previously, we recommend that hospices use data 
from their vendors for quality improvement, rather than wait for 
publicly-reported data. If we were to provide preview data a year in 
advance, the publicly reported data would be too old to be a meaningful 
reflection of the hospice's performance. We believe additional delays 
in public reporting of data is not in the interest of the public using 
Care Compare.
    Comment: Many commenters expressed concern about publicly reporting 
data that was collected and/or delivered during the COVID-19 PHE. They 
commented that these data could be skewed by the public health 
emergency.
    Response: We will not include data from Q1 and Q2 2020 in Star 
Rating calculations, as hospices were exempted from submitting these 
quarters of data to CMS due to the COVID-19 PHE.
    Comment: Several commenters stated that the CAHPS Hospice Survey is 
unlike other CAHPS surveys in that the respondents are family members 
or friends of the deceased--not the patients themselves. They believe 
this is a key difference between the hospice survey and other CAHPS 
surveys and called for more information on the Care Compare site to 
make sure consumers are not misled.
    Response: Although Care Compare already notes that for Hospice 
CAHPS the user is comparing ``. . . hospices based on results from a 
national survey that asks a family member or friend of a hospice 
patient about their hospice care experience,'' we will consider whether 
there are additional ways to highlight this.
    Comment: Some commenters objected to the comparative nature of the 
CAHPS Hospice Survey star ratings, preferring instead, a rating based 
upon an external criteria rather than one that compares hospices to 
each other. As a few commenters noted, ``Each hospice is afforded the 
opportunity to achieve excellent ratings on the CAHPS Hospice Survey. 
Similarly, this same right should be afforded hospices under the Star 
Rating system through a clear portrayal Star Rating of performance to 
consumers and the public that reflects how most respondents scored the 
hospice, not how the hospice fares compared to all other hospices.'' 
One commenter also suggested that star ratings calculations be made 
available to hospices before they are publicly reported.
    Response: Similar to other CMS CAHPS star ratings, we propose that 
the cut-points used to determine CAHPS Hospice Survey stars be 
constructed using statistical clustering procedures that minimize the 
score differences within a star category and maximize the differences 
across star categories. This ensures that star assignments clearly 
differentiate performance across groups of hospices. Such comparative 
star ratings, as proposed by CMS, help consumers identify high and low 
performing hospices. With respect to making calculations available 
before they are publicly reported, we do plan to provide star ratings 
calculations in preview reports prior to their display.
    Comment: Several commenters noted that CMS is currently conducting 
a pilot test of a revised CAHPS Hospice Survey questionnaire and 
wondered whether the release of a new questionnaire would coincide with 
the introduction of star ratings. They also questioned whether CMS 
expected that use of a revised questionnaire would increase the number 
of hospices that achieve 75 completed questionnaires and would, 
therefore, be included in star ratings.
    Response: We are currently conducting an experiment to test a new 
version of the survey, including the web mode of administration which 
may have an impact on response rates and the number of survey 
completes. Results of this experiment will help to inform changes to 
the survey in the future. We anticipate that star ratings will be 
released prior to a new version of the survey. Star ratings will 
continue to be calculated and released as we phase in the new survey 
version.
    Comment: Many commenters questioned the weighting of the components 
of the star ratings, particularly the decision to weigh the two global 
questions (Overall Rating and Willingness to Recommend) at 50 percent 
of the weight for each composite measure.
    Response: The Willingness to Recommend and Overall Rating measures 
are highly correlated with one another, as both provide global 
assessments of hospice care. Given this, weighting each of the two 
measures at 100 percent would over-emphasize global assessments of care 
relative to the other aspects of care assessed by CAHPS Hospice Survey 
measures. CMS maintains its proposal to weight Willingness to Recommend 
and Overall Rating at 50 percent each for the purpose of calculating an 
overall CAHPS Hospice Survey star rating. This approach parallels the 
one used by CMS for calculating star ratings for hospitals.
    Comment: A few commenters questioned whether it is CMS's intent for 
the CAHPS[supreg] to be the sole star rating vehicle for hospice care 
or whether there would be another star rating for HOPE measures when it 
is implemented?
    Response: The FY 2022 proposal contemplated a CAHPS-only measure in 
the short-term. At this time, it is premature to determine whether the 
HOPE tool should be used to create star ratings, either separately from 
CAHPS or in combination with CAHPS. The HOPE tool is now under 
development. We will consider other star ratings as applicable.
    Comment: One commenter recommended that CMS award star ratings in 
FY 2022, but suppress public reporting in Care Compare until the August 
2023 refresh when all the data will be after the COVID-exempted 
quarters.
    Response: As mentioned previously, we plan to display stars no 
sooner than FY 2022. We will take into consideration the option of 
starting the stars display when all data will be after the COVID-
exempted quarters.
    Comment: One commenter strongly suggested that there should be a 
``not applicable'' response option available for each question in the 
questionnaire. Indeed, they noted that ``Questions such as ``How often 
did your family member get the help he or she needed for trouble 
breathing'' or ``How often did your family member get the help he or 
she needed for constipation'' are difficult for family members to 
answer if their loved one did not experience issues with those 
symptoms.''
    Response: On the questionnaire, the respondent is asked if their 
family member experienced the symptom. If they did not experience the 
symptom, the instructions say to skip to another question. Under these 
circumstances a ``not applicable'' is not needed.
    Comment: A few commenters stated that the survey is too long. One 
commenter suggested that we should identify the key 1 or 2 questions in 
each survey domain and use them instead.
    Response: We are currently conducting an experiment to test a 
shorter version of the CAHPS Hospice Survey. Results of this experiment 
will

[[Page 42575]]

help to inform changes to the survey in the future.
    Final Decision: After consideration of the public comments, we are 
finalizing our proposal to display Hospice CAHPS Star ratings no sooner 
than FY 2022. We plan to provide opportunities for interaction with 
stakeholders to discuss our plans and methodology and to receive 
feedback prior to the start of star ratings display. We will also 
explore the feasibility of conducting a dry run of the star ratings 
with reporting to hospices via preview reports, which would occur prior 
to the start of the public display of the ratings.
9. Form, Manner, and Timing of Quality Data Submission
a. Statutory Penalty for Failure To Report
    Section 1814(i)(5)(C) of the Act requires that each hospice submit 
data to the Secretary on quality measures specified by the Secretary. 
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. We received a few 
comments on this policy. A summary of these comment and our responses 
to those comments appear below:
    Comment: We received several comments objecting to the increase in 
the percentage penalty for failure to provide quality reporting data.
    Response: We thank the commenters for their views, but as noted, 
this provision is required by section 407(b) of the CAA and does not 
permit any discretion on the part of the Secretary to implement it.
    Comment: Several commenters requested that CMS communicate widely 
and display prominently notices and information about the increase in 
the penalty for failure to comply with HQRP requirements. They 
suggested using multiple avenues of communication including the HQRP 
website and MLN Connects.
    Response: We agree that communicating widely is critically 
important, to ensure as many hospices as possible are aware not only of 
the increase in penalty, but also clearly understand the HQRP reporting 
requirements and the APU process. We will consider using multiple 
avenues for communication, including this rule, the Medicare Claims 
Manual, the HQRP website, such as the HQRP Requirements and Best 
Practices web page at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/HQRP-Requirements-and-Best-Practices and the Training and Education 
Library page at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Quality-Reporting-Training-Training-and-Education-Library. We will also 
consider opportunities to communicate through webinars, Open Door 
Forums, and other resources as relevant.
    Comment: A few commenters did not agree with the CAA 2021 provision 
that removes the prohibition on public disclosure of hospice surveys 
performed by a national accreditation agency in section 1865(b) of the 
Act, thus allowing the Secretary to disclose such accreditation 
surveys. Many commenters also noted the special focused program that 
requires 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.
    Response: The proposed regulatory policies to implement the hospice 
survey and enforcement provisions in section 407 of CAA, 2021 were 
included in CY 2022 Home Health Prospective Payment System proposed 
rule with the comment period found here: https://www.govinfo.gov/content/pkg/FR-2021-07-07/pdf/2021-13763.pdf. We encourage commenters 
to provide us input and comments on these provisions in response to 
that rule. The link to the Federal Register can be found here: CMS-
1747-P CY 2022 Home Health Prospective Payment System Rate Update. 
Note: The comment period closes on August 27, 2021.
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 11 summarizes the three timeframes. 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.
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    As illustrated in Table 11, 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 12. HQRP Compliance Checklist 
illustrates the APU and timeliness threshold requirements.
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    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-

[[Page 42577]]

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.
    We received several on the transition to iQIES. A summary of these 
comment and our responses to those comment appear below:
    Comment: Several commenters requested 6-month minimum notice prior 
to the transition of hospice to the iQIES system. Some of these 
commenters further requested that CMS provide announcements about the 
upcoming implementation of hospice in iQIES through all CMS and MAC 
communication platforms to ensure wide penetration of the message, and 
ensure a smooth transition given lessons from the transition of other 
settings to iQIES.
    Response: We appreciate that providers will benefit from advanced 
notice regarding the transition of hospice to the iQIES systems. We 
plan to communicate with the provider community via sub-regulatory 
means about the upcoming transition as the timing becomes clear, and 
will provide sufficient time and appropriate information for a smooth 
transition.
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 previously, we are finalizing our proposal 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 will publicly report the HVLDL no earlier than May 2022. We 
are also finalizing our proposal 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.
b. 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 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 
46 47 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'' \48\ to the Medicare 
Learning Network (MLN) Connects Newsletter and Other Program-Specific 
Listserv Recipients,\49\ 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,

[[Page 42578]]

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 in section F.10.b.4. For 
HIS, the quarters are defined based on submission of HIS admission or 
discharge assessments.
---------------------------------------------------------------------------

    \46\ 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.
    \47\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
    \48\ https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
    \49\ (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.
---------------------------------------------------------------------------

    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 13 
displays the original schedule for public reporting prior to the COVID-
19 PHE.
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BILLING CODE 4120-01-C
    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 COVID-19 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 13) 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

[[Page 42579]]

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 COVID-19 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.
(3). Public Reporting of HIS-based Measures With Fewer Than Standard 
Numbers of Quarters Due to COVID-19 PHE Exemption in February 2022
    As noted previously, 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 COVID-19 PHE-
affected quarters for HIS-based measures, and five of the 11 COVID-19 
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 14, 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 14.
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    Table 14 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 th e 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.
[GRAPHIC] [TIFF OMITTED] TR04AU21.153

    In Table 15, 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] TR04AU21.154


[[Page 42581]]


BILLING CODE 4120-01-C
    We also used the results presented in Table 16 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 COVID-19 PHE and its associated 
exemptions.
    We are finalizing our proposal 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 16 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 solicited public comment on this proposal to use 3 quarters of 
HIS data for the February 2022 public reporting refresh. We received 
many comments this proposal on related questions about publicly 
reporting claims-based measures using data from the COVID-19 PHE. A 
summary of the comments received regarding public reporting and our 
responses those comments appear below.
    Comment: We received several comments supporting our proposal to 
begin public reporting in February 2022 using Q3 and Q4 of 2020 and Q1 
of 2021. These commenters also suggested that CMS post a statement that 
the data displayed include care provided during the COVID-19 PHE on 
Care Compare until August 2023. One commenter opposed the public 
reporting of any quality data collected during the COVID-19 PHE (not 
just the Q1 and Q2 2020 which were subject to the exemptions), because 
of the impact COVID-19 had on hospice processes and operations.
    Response: We appreciate the commenters' support for this proposal. 
In response to the commenter who did not support this proposal, we 
would like to emphasize that, while we recognize that the impact of 
COVID-19 has impacted the hospice community, we also believe that we 
have a responsibility to consumers to make informed decisions about 
selecting care. Providing information for decision-making is all the 
more important during and in the wake of a COVID-19 PHE, when our 
health as a nation has been shaken.
    We disagree with commenters that notices should be posted on Care 
Compare regarding the inclusion of data from the COVID-19 PHE as such 
notice would not help consumers distinguish between hospices in their 
region. Instead, we will continue to post national averages for quality 
measures, and will add state scores for all measures no earlier than 
May 2022. This information will help consumers understand relative 
performance at national and local levels in light of the COVID-19 PHE.
    Given the overall positive response to our proposal, we believe 
that the proposed approach balances fairness to providers with a 
commitment to transparency and information for consumers.
    Comment: Several commenters expressed concern about publicly 
reporting claims-based measures using data from care provided during 
the COVID-19 PHE. Specifically, they stated that claims from the COVID-
19 PHE would not reflect typical hospice services. Comments specific to 
HCI noted that abnormalities due to the COVID-19 PHE would affect all 
of the indicators, while those for HVLDL indicated that the number of 
in-person visits likely fell during the COVID-19 PHE due to patient and 
caregiver preferences, with implications for quality measurement. The 
commenters recommended that CMS post a notice on Care Compare to ensure 
consumers understand the context, with particular attention to the fact 
that telehealth visits are not captured in claims reporting.
    Response: We appreciate commenters' concerns about publicly 
reporting claims from the COVID-19 PHE. As stated earlier, we pre-
emptively issued the March 27, 2020 CMS Guidance Memorandum making 2019 
Q4 and Q1 and Q2 2020 exempt from reporting requirements. In that 
Memorandum, we stated that we would 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 COVID-19 PHE onset 
in the U.S., we determined that we would use data that were submitted 
for Q4 2019. We will apply the principles of this Memorandum to new 
claims-based measures for hospice. Thus, we will publicly report claims 
data for care delivered in Q4 2019 and Q3 2020 onward, but we will not 
publicly report claims data for care delivered Q1 and Q2 of 2020. This 
approach aligns with what we are doing for the other PAC setting 
Quality Reporting Programs, including home health (see section III.G).
    We acknowledge that the COVID-19 PHE did not end at the beginning 
of Q3 2020. Our testing indicates that claims data from the COVID-19 
PHE are generally stable. Although the number of visits in did visibly 
decline in 2020, we remain committed to re-initiating publicly 
reporting of claims data beginning in Q3 2020 for the following 
reasons: (i) We believe that we have an important commitment to 
consumers of hospice care to empower them to make informed decisions. 
This is particularly important during the COVID-19 PHE; (ii) With 
annual reporting of claims data, we can reasonably state that the 
COVID-19 PHE affected hospices nationally in a similar way. Given that 
HCI is scored relative to the national average, scores will be 
accounted for as part of the measure calculation. To the extent there 
have been regional differences, we will also provide state scores for 
both HCI and HVLDL no earlier than May 2022, so that consumers can 
benchmark to more local realities.
    We respectfully disagree with commenters who have requested that we 
post a notice on Care Compare alerting consumers to potential 
abnormalities in claims data wholly or partially coming from COVID-19 
PHE (excluding Q1 and Q2 2020). Despite the COVID-19 PHE, we would 
expect that hospices would still provide comprehensive care to hospice 
patients during the pandemic, and believe that telehealth visits are 
not full substitutes for care provided in person, particularly in the 
case of the visits measured in the HVLDL and HCI measures. We 
acknowledge that there may have been an increase in refusals during the 
COVID-19 PHE. However, this increase would likely impact hospices in a 
region similarly, and thus will not impact a hospice's score relative 
to local competitors. We will include state average scores to further 
ensure any regional differences in the impact of the

[[Page 42582]]

COVID-19 PHE on hospices are captured for consumers. For these reasons, 
adding disclaimer text as suggested would not help consumers seeking 
information make decisions about care options.
    Final Decision: We are finalizing our proposal to resume public 
reporting of HIS quality measures in February 2022 using data from Q3 
and Q4 of 2020 and Q1 of 2021.
[GRAPHIC] [TIFF OMITTED] TR04AU21.155

(4). Proposal for Public Reporting of ``CAHPS Hospice Survey-based 
Measures'' Due to COVID-19 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. 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 18.) 
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 18 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 18 shows the proposed CAHPS public 
reporting schedule during and after the data freeze.

[[Page 42583]]

[GRAPHIC] [TIFF OMITTED] TR04AU21.156

    We sought 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.
    Comment: One commenter agreed with our proposal to report the eight 
most recent quarters of data for the CAHPS Hospice Survey, skipping the 
exempted quarters. They also requested that Care Compare provide 
information to users explaining that the published data included pre-
COVID quarters. They wanted this continued until all publicly-reported 
data is from after the exempted quarters.
    Response: We thank the commenter and will take this into 
consideration as information for Care Compare is developed. We will 
work with colleagues to provide information on Care Compare that alerts 
users the composition of the data.
    Final Decision: We are finalizing our 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). Removal of the Seven ``Hospice Item Set Process Measures'' From 
Public Reporting
    We are finalizing our proposal 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 are finalizing our proposal 
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 solicited public comment on this proposal to remove the seven 
HIS process measures from public reporting on Care Compare. We received 
several comments from various stakeholders. A summary of the comments 
we received on this proposal and our responses to those comments appear 
below.
    Comment: The majority of commenters supported the removal of the 
seven HIS process measures no earlier than May 2022. However, a number 
of comments suggested that CMS continue providing the option for 
consumers to view detailed information about the individual measures 
that make up the HIS Comprehensive Assessment measure for transparency. 
One commenter who opposed the proposal to remove the seven HIS measures 
expressed concern that such a removal runs counter to the objectives of 
Care Compare to provide a personalized experience. Some comments 
expressed concern about the public's ability to be aware of and find 
the seven HIS measure scores in the Provider Data Catalogue.
    Response: CMS does not believe that the public display of the 
individual process measures on Care Compare will add value 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. Conversely, the HIS 
Comprehensive Assessment Measure, which is a single composite measure, 
differentiates hospices by holding them accountable for completing all 
seven process measures to ensure these core hospice services are 
completed for all patients. This interdisciplinary, holistic scope of 
the HIS Comprehensive Assessment Measure better aligns with the 
public's expectations for hospice care. We maintain transparency since

[[Page 42584]]

stakeholders, who are interested in the seven HIS measures, will have 
access to the Provider Data Catalogue where they can find all HIS 
component measure scores.
    We respectfully disagree that having the seven HIS measures listed 
is more transparent and understandable for consumers than a concise 
summary: Market research conducted by our teams has found that ``less 
is more'' for Care Compare consumers, who become overwhelmed by too 
much information. In fact, these findings were one of the primary 
reasons we have transitioned from Hospice Compare and the other 
individual compare sites to Care Compare.
    We appreciate the concern that consumers may not know about the 
component measure scores in the Provider Data Catalogue. As we prepare 
to update Care Compare for the removal of the seven measures, we will 
consider ways to make consumers of Care Compare aware of this 
additional data, if they are interested in viewing them.
    Comment: Several commenters expressed concern about the public's 
ability to understand the meaning of the HIS Comprehensive Measure 
without being able to see the seven component measures. These 
commenters provided general and specific suggestions about how to 
display the HIS Comprehensive Measure on Care Compare if the seven HIS 
measures are removed. Several other commenters also suggested posting a 
disclaimer that the HIS Comprehensive measure only comes from the 
admission item set and may not be reflective of subsequent care.
    Response: We appreciate that the presentation of the seven HIS 
measures helped consumers understand the content of the HIS 
Comprehensive Measure. As we prepare to update Care Compare for their 
removal, we will consider ways to revise the measure description for 
the HIS Comprehensive Measure on Care Compare so that it adequately 
explains the elements contained in the measure.
    As for the request to notify consumers that the measure is based on 
admission alone, we do not believe this would help consumers use the 
measure to compare and select hospices, as intended. The HIS 
Comprehensive Measure, like any given quality measure, is one part of a 
portfolio of measures intended to provide a holistic view of care. No 
single quality measure within the portfolio is expected, or necessarily 
intended, to provide that view on its own. As we determine the most 
appropriate way to display the measure, we will ensure that the scope 
of the HIS Comprehensive Measure is clear for consumers, who can use 
the information with other information on the website to make their 
decisions.
    Comment: A number of commenters suggested that CMS continue 
providing the option for hospices to view detailed information about 
the individual measures that make up the HIS Comprehensive Assessment 
measure to support quality improvement.
    Response: We will ensure that the confidential QM reports continue 
to include the seven HIS process measures, in addition to the HIS 
Comprehensive Assessment Measure. This helps hospices apply quality 
improvement processes to continue improving their performance on the 
HIS Comprehensive Assessment Measure.
    Final Decision: We are finalizing our proposal to remove the seven 
HIS process measures no earlier than the May 2022 refresh from public 
reporting on Care Compare and from the Preview Reports but continue to 
have them publicly available in the data catalogue.
(2). 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 to adopt 
the HCI into the HQRP for FY2022. In this section, we presented three 
proposals related to calculating and reporting claims-based measures, 
with specific application to HVLDL and HCI. First, we are finalizing 
our proposal 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 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).
    We are finalizing the proposed timeframe which 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 
the 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 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 are finalizing our proposal to 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 are finalizing our proposal to 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 patient stays each 
year have quality measure results publicly available on Care Compare. 
This public reporting threshold protects the privacy

[[Page 42585]]

of patients who seek care at smaller hospices. However, due to the 
threshold, at least some hospices will not achieve the minimum patient 
stays 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] TR04AU21.157

    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 2 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 42586]]

[GRAPHIC] [TIFF OMITTED] TR04AU21.158

    Given these findings, we are finalizing our proposal to use 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 solicited public comment on these proposals related to the use 
of 2 years of data for claims-based measures and public reporting of 
claims measures in general and their application to HVLDL and HCI 
specifically. We received several comments from various stakeholders on 
this proposal. A summary of the comments we received on this proposal 
and our responses to those comments appear below:
    Comment: A few commenters expressed concern that hospices would not 
be able to view data close to real time, which might inhibit the 
ability to use the score to inform continuous quality improvement.
    Response: We agree that there is a lag time between the delivery of 
care and the calculation and reporting of the claims-based quality 
measures, including HCI. However, the time is needed. After the data 
extract is created after the 90-day run-off, it takes several months to 
incorporate other data needed for the calculations. We then need to 
generate and check the calculations before posting for confidential 
reporting. Our proposal for using the 90-day run-off strikes a balance 
between allowing time for hospices to make corrections to their claims, 
while also seeking to post more rather than less up-to-date 
information. We have streamlined our processes as much as possible, and 
time is needed to go through these steps to ensure accurate publication 
of quality measure data.
    Comment: Several commenters requested that CMS issue confidential 
reports with hospices' claims-based measure scores in CASPER to help 
hospices understand and validate their scores before they are publicly 
reported.
    Response: Section 1814(i)(5)(E) of the Act requires that the 
Secretary establish procedures for making HQRP data available to the 
public and ensure that hospices have the opportunity to review HQRP 
data before their release to the public. We will provide this 
opportunity to review for claims-based measures in a process similar to 
HIS-based measures. Hospices can review and correct their HIS data 
before the Data Correction Deadline; for claims data, hospices will be 
able to ensure that the data are accurate through the end of the 90-day 
run-off period. Subsequently, as with HIS-based measures, we will 
implement a 30-day preview period for claims-based measures, which will 
serve as the final opportunity for hospices to review their data and 
alert CMS about any errors in the measure calculations they identify. 
Should a hospice believe they have found an error with an HIS or 
claims-based measure calculation as displayed in their preview reports, 
they can request a review, and we will suppress if the review finds the 
calculation problematic. We refer readers to the HQRP website at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Public-Reporting-HIS-Preview-Reports-and-Requests-for-CMS-Review-of-HIS-Data, which we will revise 
to include further information on public reporting of claims as well as 
HIS data. This page covers information about for accessing reports and 
an email address should hospices have questions regarding any of the 
above-mentioned reports or processes.

[[Page 42587]]

    In addition to the Preview Report, we will also include claims-
based measure scores in the Hospice Agency-Level QM Report in CASPER. 
This report is intended to support quality improvement for hospices. 
Measure scores will be updated annually in the QM Report as they will 
in the Preview Report and on Care Compare and the Provider Data 
Catalogue.
    Comment: We received several comments with a request for CMS to 
consider quarterly as opposed to annual reporting of claims-based 
measures to best support continuous quality improvement activities.
    Response: Our proposal to update annually reflects our 
understanding that claims measures reflect business practices that are 
slow to change. For example, for HCI, as we discussed in the proposed 
rule, we compared index scores calculated for the same hospice using 
annual claims from Federal FY 2017 and 2019. The analysis found that 
83% of hospices had HCI scores that were 0-1 percentage points 
different in FY2019 relative to their FY2017 scores. These results 
indicate that a hospice's HCI scores would not normally fluctuate a 
great deal from one year to the next, and that they will fluctuate even 
less from quarter to quarter. Thus, quarterly updates would not 
necessarily provide meaningful support to hospices seeking to improve 
their quality of care. Instead, progress on HCI will occur over longer 
time frames, and annual updates are sufficient to support hospices' 
efforts to improve.
    Other PAC settings show similar findings regarding the stability of 
claims measures compared to assessment scores, which we update 
quarterly. In the home health setting, for example, national median 
scores for OASIS-based measures tend to increase, while the acute care 
hospitalization measure remains steady (Figure 3).
[GRAPHIC] [TIFF OMITTED] TR04AU21.159

    At the same time, reporting claims-based measures does require 
additional labor. Given the findings about stability in claims measure 
scores, and the cost of updating more frequently, all PAC settings 
update claims-based measures annually. Hospital claims-based measures 
are also updated annually. The HQRP seeks to align with the other 
settings.
    Given the findings and considerations, we believe that our proposal 
to provide annual updates is appropriate. However, we will remain open 
to reconsidering the frequency of reporting claims across all PAC 
settings in the future, should data after implementation indicate that 
such change is warranted.
    Comment: One commenter expressed concern that CMS would obtain the 
data from cost reports, which would not allow them time to understand 
or preview the measures before they were publicly reported.
    Response: We will not pull claims data for calculating the measures 
from cost reports. Instead, it will come from our research database 
that contains Medicare files including fee-for-service claims data. As 
stated, data source and timing will allow time for hospices to preview 
their measure scores before they are publicly reported.
    Comment: We received comments in support of the proposal to use two 
years of data for publicly reporting HVLDL and HCI. One of these 
commenters expressed support for making the reporting more inclusive of 
smaller hospices, to encourage them to also improve the quality of care 
they provide. Other commenters suggested using a 1-year time frame, so 
as to make the measure score more reflective of current operations and 
performance, and thus more understandable and useful for providers and 
consumers. Some commenters recommended adding a disclaimer that the 
data are two years old and do not reflect the current status of hospice 
performance.
    Response: We agree that there are benefits to reporting just one 
year of data. However, we also believe that we must strike a balance 
between the benefits of reporting fewer years of more timely data with 
the need to be more inclusive of smaller hospices, which MedPAC has 
found have higher live discharge rates than larger hospices.\50\ In 
other settings, some claims-based measures also use two or even three 
years of data for reporting. For example, as part of the Home Health 
Quality Reporting Program, the Potentially Preventable 30-Day Post-
Discharge Readmission measure is reported using three years of data, 
while Medicare Spending Per Beneficiary and Discharge to Community 
measures are reported using two years of data. We also considered using 
three years of data for HVLDL and HCI, and determined that three years 
did not yield the same benefit (that is, inclusion of hospices) 
relative to cost (that is, lag in reporting), and thus proposed using 
two years of data. With two years of data, 50 percent

[[Page 42588]]

of the data come from the more recent year, and hospices should still 
be able to see their scores change as their performance improves.
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    \50\ MedPAC. 2020. Report to the Congress: Medicare Payment 
Policy [bond] March 2020. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf?sfvrsn=0. Accessed June 13, 2021.
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    Final Decision: We are finalizing as proposed our proposals to use 
90-day run-off data to calculate claims-based measures, to update 
claims-based measure scores annually, and to use eight quarters of data 
to report HVLDL and HCI.
(3). Publicly Report the Hospice Care Index and ``Hospice Visits in the 
Last Days of Life'' Claims-Based Measures
    As discussed previously, we are finalizing our proposal to publicly 
report the HCI and HVLDL using 2 years, which is 8 quarters of Medicare 
claims data. We will publicly report the HCI and HVLDL beginning no 
earlier than May 2022, 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 solicited public comment on this proposal for HCI and HVLDL 
public reporting on Care Compare no sooner than May 2022. A summary of 
the comments we received on this proposal and our responses to those 
comments appear below:
    Comment: Many commenters requested clarification on the reporting 
period for initial reporting. They also requested clarification on the 
logistics of the reporting process--in particular, when specifications 
would be available.
    Response: We appreciate the opportunity to provide clarification. 
If released in May 2022 using eight quarters of data, the HCI and HVLDL 
measure reporting period would begin with FY2021 (Q1, Q2, and Q3 2021 
and Q4 2020). The next four quarters would be Q3 2020 and Q2, Q3, and 
Q4 of 2019--that is, past quarters adding up to eight quarters but 
omitting Q1 and Q2 of 2020, which were exempt from quality reporting 
(please see section 10.b.(2) above, ``Update on Use of Q4 2019 Data and 
Data Freeze for Refreshes in 2021''). As provided in sections III F(3). 
``Addition of a ``claims-based index measure'', the Hospice Care 
Index'' and III F(4). ``Update on the Hospice Visits in the Last Days 
of Life (HVLDL) and Hospice Item Set V3.00'', we gave sufficient 
information in the proposed rule and this final rule to calculate HCI 
and HVLDL and access specifications. The HQRP will post a revised QM 
Users' Manual that contains HCI and HVLDL no later than October 1, 2021 
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.
    Comment: We received several comments expressing concern about the 
timing for publicly reporting HVLDL and HCI on Care Compare and the 
Provider Data Catalogue. Commenters requested sufficient time to 
understand the measures, set up monitoring systems (sometimes with 
vendor support), assess trends in their performance relative to 
national benchmarks, and develop plans for quality improvement, as CMS 
normally provides. One noted that this time is needed in particular 
because visits on claims have not previously impacted hospice quality 
scores or payment. Others noted that the delay could allow time for 
additional analysis of the measure, and for more transparency about the 
rationale for it. Many of these commenters requested that CMS wait a 
year (until 2023) to publicly report the measures, while also 
requesting to confidential reports with the claims-based measures as 
soon as possible. One commenter requested a minimum of 6 months from 
the date final specifications are available for EMR and other vendors 
to respond to any changes in the HQRP.
    Response: As stated in section III F(3)(e). ``Form, Manner and 
Timing of Data Collection and Submission'', we have provided and will 
consolidate in the Users' Manual specifications for HCI and HVLDL in 
time to meet commenters' stated needs. In addition, we will provide 
hospices with confidential reporting of their HVLDL and HCI measure 
scores in the Agency-Level QM report after this rule is finalized--
after August 2021. This would allow sufficient time to complete the 
activities related, which is what we normally aim to give providers to 
understand and prepare for public reporting of a new measure, if we 
publicly report in May 2022. We believe that the QM report and Provider 
Preview report will provide an indication on how well the hospice is 
performing as well as opportunities to provide CMS feedback on 
technical issues with the measures. To further support the hospice 
community, we will also provide education, training, and additional 
opportunities for hospices to receive information about the measures 
through open door forums or other venues.
    Although these measures represent the first time that hospices are 
held accountable for visits information in claims, the measures reflect 
ideas about best practice and compliance that hospices have already 
known. While we are committed to provide time for understanding and 
preparation, we are not committed to ensuring that all hospices achieve 
high scores on the new measures before publicly reporting them. For 
these reasons, we believe that no additional dry run period is 
warranted.
    Comment: A commenter suggested that CMS should not use claims data 
from a time period before a measure is finalized through rulemaking.
    Response: Our practice across all PAC settings has been to allow 
the use of claims data originating from before the finalization of a 
proposal to adopt a claims-based measure. For example, for the Home 
Health QRP, we finalized the Potentially Preventable 30-Day Post-
Discharge Readmission Measure in the CY 2017 Home Health QRP Rule (81 
FR 76770 through 76775) for reporting with three consecutive years of 
claims data beginning with the CY 2018 Home Health QRP.
    Comment: Commenters recommended using simple language to describe 
HVLDL on Care Compare, to ensure that the average consumer will 
understand it. For HVLDL, one commenter suggested that CMS notify 
consumers that the measure does not capture visits from chaplains, 
volunteers, hospice aides, and complementary therapies, among others. 
For HCI, several commenters expressed concern about CMS's ability to 
help consumers interpret it in a way that helps support informed 
decision-making. For example, an average consumer might misinterpret 
higher scores for live discharges or avoidance of general inpatient 
care as favorable.
    Response: We also believe in the importance of using simple 
language on Care Compare to ensure consumers can easily use and 
appropriately interpret quality information that we provide for their 
decision-making. As with any measure included in the HQRP, we are 
committed to providing all users with the necessary information to 
understand the intent and application of measures in the HQRP. Before 
we publicly report this measure, we will provide resources to aid the 
public in interpreting publicly displayed quality data. For HVLDL 
specifically, we will list the multi-disciplinary team member visits 
that are included in the measure as part of the measure description 
displayed on Care Compare.
    For the public display of HCI, our measure development contractor 
convened two small caregiver workgroups to gather impressions and input 
on the value of HCI for consumers. The caregivers were generally 
receptive and positive about the HCI as an additional measure for the

[[Page 42589]]

Hospice QRP, and expressed interest in the indicator-level information 
as well as the index score to better understand the hospice. Their 
response confirmed our understanding that the data included in HCI will 
be useful for patients and families as they compare and select hospice 
providers. Based on the caregivers' feedback, we proposed reporting the 
HCI as a single score to report on Care Compare, while providing the 
indicator scores in the Provider Data Catalog (PDC). We will continue 
to apply ideas shared by the Caregiver Workgroup participants as we 
refine plans for the measure's public display to minimize the risk of 
misinterpretation.
    Final Decision: We are finalizing as proposed to publicly report 
the HCI and HVLDL beginning no earlier than May 2022, and to include it 
in the Preview Reports no sooner than the May 2022 refresh.
(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, 
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 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.

[[Page 42590]]

G. 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).
     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 proposed 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 refresh. 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.\51\
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    \51\ 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,\52\ 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.
---------------------------------------------------------------------------

    \52\ (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

[[Page 42591]]

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 (HH CAHPS) Survey measures on Care 
Compare. As of September 2020, HH QRP OASIS, claims-based, and HH CAHPS 
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 proposed resuming 
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 20 displays the original schedule for public reporting 
of OASIS and HH CAHPS Survey measures prior to the Q1 and Q2 2020 data 
impacted by the COVID-19 PHE.

[[Page 42592]]

[GRAPHIC] [TIFF OMITTED] TR04AU21.160

    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,

[[Page 42593]]

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 COVID-19 PHE onset, we determined that we would not use HH QRP 
OASIS, claims, or HH CAHPS 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 20), the 
October 2020 refresh included Q4 2019 measure based on OASIS and HH 
CAHPS 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 exception, 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 HH CAHPS 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. Application of the COVID-19 PHE Affected Reporting (CAR) Scenario To 
Publicly Display Certain HH QRP Measures (Beginning in January 2022 
Through July 2024)
    We also proposed 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 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 HH 
CAHPS Survey measures are outlined in Table 20.
    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 COVID-19 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 COVID-19 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.

[[Page 42594]]

    Testing results showed that using the CAR scenario would achieve 
scientifically acceptable quality measure scores for the HH QRP. As 
displayed in Table 21, 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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[[Page 42595]]

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[[Page 42596]]


[GRAPHIC] [TIFF OMITTED] TR04AU21.162

    We proposed to use the CAR scenario for the last of the refreshes 
affecting OASIS-based measures, which will occur in January 2022. We 
also proposed to use the CAR scenario for refreshes from January 2022 
through July 2024 for some claims-based measures.
    Our proposal to adopt 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 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 22 
and Table 23 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.
[GRAPHIC] [TIFF OMITTED] TR04AU21.163

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[[Page 42597]]

[GRAPHIC] [TIFF OMITTED] TR04AU21.164

    We solicited 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. A 
summary of the comments we received on this proposal and our responses 
to those comments appear below:
    Comment: We received many comments supporting HH QRP reporting to 
resume beginning January 2022. One commenter suggested including a 
statement that data cover care provided during the COVID-19 PHE for 
eight quarters.
    Response: We thank commenters for their support of this proposal on 
public reporting for refreshes affected by the exceptions. However, we 
do not agree with the commenter who suggested including a statement on 
Care Compare regarding the inclusion of data from the COVID-19 PHE 
because such an announcement will not help consumers distinguish 
between HHAs in their region. Instead, we will continue to post state 
and national averages for HH QRP measures. This information will help 
consumers understand relative performance at national and local levels 
in light of the COVID-19 PHE.
    Given the overall positive response to our proposal, we believe 
that the proposed approach balances fairness to providers with a 
commitment to transparency and information for consumers.
    Final Decision: We are finalizing our proposal to use the CAR 
scenario for refreshes for January 2022 for OASIS-based measures and 
for refreshes from

[[Page 42598]]

January 2022 through July 2024 for some claims-based measures.
6. Update to the Public Display of HH CAHPS Measures Due to the COVID-
19 PHE Exception
    Since April 2012, we have publicly displayed four quarters of HH 
CAHPS 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 24. Beginning with January 2022, we 
will resume reporting four quarters of HH CAHPS data. The data for the 
January 2022 refresh are Q3 2020 through Q2 2021. These are the same 
quarters that would have been publicly displayed despite the COVID-19 
PHE. Table 24 summarizes this discussion.
[GRAPHIC] [TIFF OMITTED] TR04AU21.165

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

    Through the proposed rule, we sought input on the following steps 
that would enable transformation of CMS' quality measurement enterprise 
to be fully digital (86 FR 19765):

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 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

[[Page 42599]]

transformation to dQMs leveraging health IT standards. While we stated 
that we would not be responding to specific comments submitted in 
response to this Request for Information in the FY 2022 Hospice Wage 
Index 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.
    Comments: We received many comments expressing support for the 
adoption of a standardized definition of dQM in the hospice setting and 
the use of Fast Healthcare Interoperability Resources (FHIR) to support 
quality measurements in the HQRP. Many commenters noted that there is a 
great deal of variation among FHIR systems, which could impede the 
adoption of a standard system across hospices. Commenters also 
expressed issues surrounding interoperability capabilities of EHR 
vendor systems noting that currently, some EHR vendors do not include 
features important for interoperability as a part of their base 
product, which would represent additional costs for hospices which can 
lead to affordability issues for many providers. Furthermore, 
commenters noted that interoperability challenges lead to complications 
when sharing health information with other providers. They encouraged 
HHS to continue pursuing adoption of FHIR APIs for health IT vendors.
    We also received several comments responding to how CMS should 
incentivize the use of HIT. Commenters noted that hospices were not 
included in the EHR Incentive Program, which provided grants to 
hospices to develop HIT systems. We received many comments emphasizing 
that financial incentives would encourage providers to adopt new HIT 
systems and work to reduce burden using FHIR and EHR. Commenters also 
encouraged CMS to provide early testing and education for providers on 
HIT and to provide a structured FHIR transition framework for key 
stakeholders.
    We also received several comments explaining the various EHR/HIT 
systems currently in use, as well as discussions surrounding health 
information exchange with other providers.
    Response: While we stated that we would not be responding to 
specific comments submitted in response to this RFI in the FY 2022 
Hospice Wage Index final rule, we appreciate all of the comments and 
interest in this topic. We will continue to take all concerns, 
comments, and suggestions into account as we consider Fast Healthcare 
Interoperability Resources (FHIR) in support of Digital Quality 
Measurement in Post-Acute Care Quality Reporting Programs.

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

    While hospice is not included in the Improving Medicare Post-Acute 
Care Transformation Act of 2014 (IMPACT Act of 2014) (Pub. L. 113-185), 
we sought comment on the possibility of revising measure development, 
and the collection of other data that address gaps in health equity in 
HQRP (86 FR 19766). 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. We 
invited 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 standardized patient assessment 
data elements adoption that could apply to hospice in alignment with 
national data collection and interoperable exchange standards. This 
could include collecting information on race, ethnicity, and certain 
SDOH, including preferred language, interpreter services, health 
literacy, transportation and social isolation. This could also include 
guidance on any additional items, including standardized patient 
assessment and data elements 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 were also interested in feedback regarding whether 
including facility-level quality measure results stratified by social 
risk factors and social determinants of health (and relevant proxies, 
such as dual eligibility for Medicare and Medicaid, and 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 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)).
     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 stated that we would not be responding to specific 
comments submitted in response to this RFI in the FY 2022 Hospice Wage 
Index final rule, we appreciate all of the comments and interest in 
this topic. We will continue to take all concerns, comments, and 
suggestions into account as we continue work to address and develop 
policies on this important topic. It is our hope to provide additional 
stratified information to providers related to race and ethnicity if 
feasible. The provision of stratified measure results will allow 
hospices to understand how they are performing with respect to certain 
patient risk groups, to support these providers in their efforts to 
ensure equity for all of their patients, and to identify opportunities 
for improvements in health outcomes.
2. Public Comments Summarized
    We received many comments about the use of standardized patient 
assessment data in the hospice setting to assess health equity and 
social determinants of health (SDOH). Many commenters noted a 2019 Abt 
Associates and RAND Corporation study which excluded hospices from the 
standardized data elements for patient assessment denominator, citing 
that hospice patients have a different goal of care which does not 
align with standardized data elements for patient assessment. 
Commenters encouraged CMS to only utilize certain aspects of 
standardized data elements for patient assessment (specifically, Z-
codes 55-65) in collecting health equity data. We also received some 
comments which expressed that standardized data elements for patient 
assessment does not currently capture the current understanding of 
SDOH.
    We also received feedback from several commenters about additional 
factors which should be considered when collecting data about health 
equity and disparities. We noted several categories, including: 
culture, spiritual beliefs, food insecurity, access to interpreter 
services, health literacy,

[[Page 42600]]

caregiving, housing scarcity, marital status, and socioeconomic status. 
Commenters encouraged CMS to stratify quality measures by demographic 
data, social risk factors, and social determinants of health.
    We also noted a comment encouraging CMS to implement a best-
practice assessment for the collection of demographic and SDOH data. A 
commenter noted that there is not a standard initial nursing or social 
worker assessment that currently screens for SDOH.
    One commenter also expressed a desire to include permanent 
telehealth provisions in the QRP, as that would help improve rural 
healthcare access.
    We appreciate all the comments and interest in this topic. We 
believe that this input is very valuable in the continuing development 
of the CMS health equity quality measurement efforts. We will continue 
to take all concerns, comments, and suggestions into consideration for 
future development and expansion of our health equity quality 
measurement efforts.

V. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule before 
the provisions of the rule are finalized, either as proposed or as 
amended in response to public comments, and take effect, in accordance 
with the Administrative Procedure Act (APA) (Pub. L. 79-404), 5 U.S.C. 
553, and, where applicable, section 1871 of the Act. Specifically, 5 
U.S.C. 553 requires the agency to publish a notice of the proposed rule 
in the Federal Register that includes a reference to the legal 
authority under which the rule is proposed, and the terms and substance 
of the proposed rule or a description of the subjects and issues 
involved. Further, 5 U.S.C. 553 requires the agency to give interested 
parties the opportunity to participate in the rulemaking through public 
comment before the provisions of the rule take effect. Similarly, 
section 1871(b)(1) of the Act requires the Secretary to provide for 
notice of the proposed rule in the Federal Register and a period of not 
less than 60 days for public comment for rulemaking carrying out the 
administration of the insurance programs under title XVIII of the Act. 
Section 1871(b)(2)(C) of the Act and 5 U.S.C. 553 authorize the agency 
to waive these procedures, however, if the agency for good cause finds 
that notice and comment procedures are impracticable, unnecessary, or 
contrary to the public interest and incorporates a statement of the 
finding and its reasons in the rule issued.
    We are revising the provisions at Sec.  418.306(b)(2) 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. We noted this revised statutory requirement 
in our proposed rule (86 FR 19726) and are codifying the revision at 
Sec.  418.306(b)(2). While we received comments, this update is 
statutorily required and self-implementing. Notice and comment are 
unnecessary because we are conforming the regulation to statute and 
there is no discretion on the part of the Secretary.

VI. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
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.

A. ICRs Regarding Hospice QRP

    We are revising the provisions at Sec.  418.306(b)(2) 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. We noted this revised statutory requirement 
in our proposed rule (86 FR 19726) and are codifying the revision at 
Sec.  418.306(b)(2). While we received comments, this update is 
statutorily required and self-implementing. Notice and comment are 
unnecessary because we are conforming the regulation to statute and 
there is no discretion on the part of the Secretary. 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-
information collection request (ICR) -CMS-10390 (OMB Control Number: 
0938-1153 (Expiration date: February 29, 2024).
     Finally, the Home Health 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 revising 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 revision is subject to the PRA; however, 
the information collection burden associated with the existing 
requirements at Sec.  418.76(c)(1) are accounted for under the 
information collection request currently approved OMB control number 
0938-1067 (Expiration date: March 31, 2024). We requested public 
comment in determining if 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)

[[Page 42601]]

would reduce burden on the provider. While comments were overwhelmingly 
supportive, we did not receive any comments that would support burden 
changes.
    We are also revising 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). While many commenters 
indicated that the proposed changes increase efficiency of training, 
none provided specific information or data to describe a change in 
burden. Additionally, we believe that both the requirements at Sec.  
418.76(h) are exempt from the PRA. In accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2), 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 
CoPs--CMS-10277 (OMB control number 0938-1067). Therefore, we are not 
seeking OMB approval for any information collection or recordkeeping 
activities that may be conducted in connection with the revisions to 
Sec.  418.76(h).

VII. Regulatory Impact Analysis

A. Statement of Need

    This final rule meets the requirements of our regulations at Sec.  
418.306(c) and (d), which require annual issuance, in the Federal 
Register, of the hospice wage index based on the most current available 
CMS hospital wage data, including any changes to the definitions of 
CBSAs or previously used MSAs, as well as any changes to the 
methodology for determining the per diem payment rates. This final rule 
also updates 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. Lastly, section 3004 of the 
Affordable Care Act amended the Act to authorize a quality reporting 
program for hospices, and this rule discusses changes in the 
requirements for the HQRP in accordance with section 1814(i)(5) of the 
Act.

B. Overall Impacts

    We estimate that the aggregate impact of the payment provisions in 
this rule will result in an increase of $480 million in payments to 
hospices, resulting from the hospice payment update percentage of 2.0 
percent for FY 2022. The impact analysis of this 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.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by OMB.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). Based on our estimates, OMB's Office of Information and 
Regulatory Affairs has determined that this rulemaking is 
``economically significant'' as measured by the $100 million threshold, 
and hence also a major rule under Subtitle E of the Small Business 
Regulatory Enforcement Fairness Act of 1996 (also known as the 
Congressional Review Act), 5 U.S.C. 804(2). Accordingly, we have 
prepared a RIA that, to the best of our ability presents the costs and 
benefits of the rulemaking.

C. Detailed Economic Analysis

1. Hospice Payment Update for FY 2022
    The FY 2022 hospice payment impacts appear in Table 25. 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 final 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

[[Page 42602]]

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 2.0 
hospice payment update percentage is based on the 2.7 percent inpatient 
hospital market basket update, reduced by a 0.7 percentage point 
productivity adjustment. The sixth column shows the effect of all the 
proposed changes on FY 2022 hospice payments. It is projected that 
aggregate payments would increase by 2.0 percent; assuming hospices do 
not change their billing practices. As illustrated in Table 25, 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 May 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 25, the combined effects of all the 
proposals vary by specific types of providers and by location.
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[[Page 42603]]


[GRAPHIC] [TIFF OMITTED] TR04AU21.167

2. Regulatory Review Cost Estimation
    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this rule, we should 
estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review 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 rule. We acknowledge that this assumption may understate or 
overstate the costs of reviewing this 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 final rule. We also

[[Page 42604]]

recognize that different types of entities are in many cases affected 
by mutually exclusive sections of the final rule, and therefore, for 
the purposes of our estimate we assume that each reviewer reads 
approximately 50 percent of the 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 final rule consists of approximately 72,000 
words. Assuming an average reading speed of 250 words per minute, it 
would take approximately 2.4 hours for the staff to review half of it. 
For each hospice that reviews the rule, the estimated cost is $274.18 
(2.4 hour x $114.24). Therefore, we estimate that the total cost of 
reviewing this regulation is $14,531.54 ($274.18 x 53 reviewers).

D. Accounting Statement and Table

    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 26, we have prepared an accounting statement showing 
the classification of the expenditures associated with the provisions 
of this final rule. Table 26 provides our best estimate of the possible 
changes in Medicare payments under the hospice benefit as a result of 
the policies in this rule. This estimate is based on the data for 4,995 
hospices in our impact analysis file, which was constructed using FY 
2020 claims available in May 2021. All expenditures are classified as 
transfers to hospices.
[GRAPHIC] [TIFF OMITTED] TR04AU21.168

E. Regulatory Flexibility Act (RFA)

    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 2.0 percent, or 
$480 million. The distributional effects of the final 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 certified 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 604 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 certified that this rule will not have a significant 
impact on the operations of a substantial number of small rural 
hospitals (see Table 25).

F. Unfunded Mandates Reform Act (UMRA)

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2021, that 
threshold is approximately $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 in any 1 
year.

G. Federalism

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on state 
and local governments, preempts state law, or otherwise has Federalism 
implications. We have reviewed this rule under these criteria of 
Executive Order 13132, and have determined that it will not impose 
substantial direct costs on state or local governments.

H. Conclusion

    We estimate that aggregate payments to hospices in FY 2022 will 
increase by $480 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, 2.0 percent increase in 
estimated payments compared to FY 2021. While hospices in rural areas 
will experience, on average, 2.2 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 2.9 percent and 2.5 percent, respectively. Hospices 
serving patients in areas in the New England and Middle Atlantic 
regions would experience, on average, the

[[Page 42605]]

lowest estimated increase of 1.2 percent in FY 2022 payments.
    This final regulation is subject to the Congressional Review Act 
provisions of the Small Business Regulatory Enforcement Fairness Act of 
1996 (5 U.S.C. 801 et seq.) and has been transmitted to the Congress 
and the Comptroller General for review.
    I, Chiquita Brooks-LaSure, Administrator of the Centers for 
Medicare & Medicaid Services, approved this document on July 23, 2021.

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 amends 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 the beneficiary (or representative) 
refuses to sign the addendum, the hospice must document on the addendum 
the reason the addendum was not signed and the addendum would become 
part of the patient's medical record. 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) 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 signed in order for 
the hospice to receive payment. The hospice must note (on the addendum 
itself) 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 418.306 is amended by revising paragraph (b)(2) to read as 
follows:

[[Page 42606]]

Sec.  418.306   Annual update of the payment rates and adjustment for 
area wage differences.

* * * * *
    (b) * * *
    (2) For fiscal years 2014 and through 2023, in accordance with 
section 1814(i)(5)(A)(i) of the Act, in the case of a Medicare-
certified hospice that does not submit hospice quality data, as 
specified by the Secretary, the payment rates are equal to the rates 
for the previous fiscal year increased by the applicable hospice 
payment update percentage increase, minus 2 percentage points. 
Beginning with fiscal year 2024 and subsequent fiscal years, the 
reduction increases to 4 percentage points. Any reduction of the 
percentage change will apply only to the fiscal year involved and will 
not be taken into account in computing the payment amounts for a 
subsequent fiscal year.
* * * * *

0
6. 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
7. 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 fulfill the HQRP requirements for Sec.  
418.306(b).
    (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: July 27, 2021.
Xavier Becerra,
Secretary,
Department of Health and Human Services.
[FR Doc. 2021-16311 Filed 7-29-21; 4:15 pm]
BILLING CODE 4120-01-P