[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Proposed Rules]
[Pages 19700-19774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07344]
[[Page 19699]]
Vol. 86
Wednesday,
No. 70
April 14, 2021
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 418 and 484
Medicare Program; FY 2022 Hospice Wage Index and Payment Rate Update,
Hospice Conditions of Participation Updates, Hospice and Home Health
Quality Reporting Program Requirements; Proposed Rule
Federal Register / Vol. 86 , No. 70 / Wednesday, April 14, 2021 /
Proposed Rules
[[Page 19700]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 418 and 484
[CMS-1754-P]
RIN 0938-AU41
Medicare Program; FY 2022 Hospice Wage Index and Payment Rate
Update, Hospice Conditions of Participation Updates, Hospice and Home
Health Quality Reporting Program Requirements
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This rule proposes updates to the hospice wage index, payment
rates, and aggregate cap amount for Fiscal Year 2022. This rule
proposes changes to the labor shares of the hospice payment rates,
proposes clarifying regulations text changes to the election statement
addendum that was implemented on October 1, 2020, includes information
on hospice utilization trends and solicits comments regarding hospice
utilization and spending patterns. In addition, this rule proposes to
make permanent selected regulatory blanket waivers that were issued to
Medicare-participating hospice agencies during the COVID-19 public
health emergency and updates the hospice conditions of participation.
The proposed rule would update the Hospice Quality Reporting Program.
The proposed rule requests information on advancing to digital quality
measurement, the use of Fast Healthcare Interoperability Resources,
addresses the White House Executive Order related to health equity in
the Hospice Quality Reporting Program and provides updates to advancing
Health Information Exchange. Finally, this rule proposes changes
beginning with the January 2022 public reporting for the Home Health
Quality Reporting Program to address exceptions related to the COVID-19
public health emergency.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below by June 7, 2021.
ADDRESSES: In commenting, refer to file code CMS-1754-P.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1754-P, P.O. Box 8010,
Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1754-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
For general questions about hospice payment policy, send your
inquiry via email to: [email protected].
For questions regarding the CAHPS[supreg] Hospice Survey, contact
Debra Dean-Whittaker at (410) 786-0848.
For questions regarding the hospice conditions of participation
(CoPs), contact Mary Rossi-Coajou at (410)786-6051.
For questions regarding the home health public reporting, contact
Charles Padgett (410) 786-2811.
For questions regarding the hospice quality reporting program,
contact Cindy Massuda at (410) 786-0652.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments.
Wage index addenda will be available only through the internet on
our website at: (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index.html.)
I. Executive Summary
A. Purpose
This rule proposes updates to the hospice wage index, payment
rates, and cap amount for Fiscal Year (FY) 2022 as required under
section 1814(i) of the Social Security Act (the Act). In addition, this
rule proposes to rebase the labor shares of the hospice payment rates
and proposes clarifying regulations text changes to the election
statement addendum requirements finalized in the FY 2020 Hospice Wage
Index and Payment Rate Update final rule (84 FR 38484). This rule also
includes information on hospice utilization trends and solicits
comments regarding hospice utilization and spending patterns. In
addition, this rule proposes to make permanent selected regulatory
blanket waivers for hospice agencies during the COVID-19 Public Health
Emergency (PHE) and proposes revisions to the hospice conditions of
participation (CoPs). This rule proposes changes to the Hospice Quality
Reporting Program (HQRP), requests information on advancing to digital
quality measurement and the use of Fast Healthcare Interoperability
Resources (FHIR), addresses the White House Executive Order related to
health equity in the HQRP and provides updates on advancing the Health
Information Exchange. Finally, this rule proposes changes to the Home
Health Quality Reporting Program (HH QRP) to address the January 2022
refresh in accordance with sections 1895(b)(3)(B)(v)(III) and
1899(B)(f) of the Act.
B. Summary of the Major Provisions
Section III.A of this proposed rule includes data analysis on
historical hospice utilization trends. The analysis includes data on
the number of beneficiaries using the hospice benefit, live discharges,
reported diagnoses on hospice claims, Medicare hospice spending, and
Parts A, B and D non-hospice spending during a hospice election. In
this section, we also solicit comments from the public, including
hospice providers as well as patients and advocates, regarding the
presented analysis on hospice utilization and spending patterns. We
also include questions related to non-hospice spending during a hospice
election.
Section III.B of this proposed rule proposes to rebase and revise
the labor shares for continuous home care (CHC), routine home care
(RHC), inpatient respite care (IRC), and general inpatient care (GIP)
using 2018 Medicare cost report (MCR) data for freestanding hospice
facilities.
Section III.C proposes updates to the hospice wage index and makes
the application of the updated wage data budget neutral for all four
levels of hospice care. In section III.C of this rule, we also discuss
the proposed FY 2022 hospice payment update percentage of 2.3 percent,
updates to the hospice payment rates, as well as the updates to
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the hospice cap amount for FY 2022 by the hospice payment update
percentage of 2.3 percent.
Section III.D proposes clarifying regulations text changes
regarding the election statement addendum requirements that were
finalized in the FY 2020 Hospice Wage Index and Rate Update final rule
(84 FR 38484).
Section III.E proposes to make permanent selected regulatory
blanket waivers that were issued to Medicare-participating hospice
agencies during the COVID-19 PHE. We are proposing to revise hospice
aide requirements to allow the use of the pseudo-patient for conducting
hospice aide competency evaluations. We are also proposing to revise
the provisions at Sec. 418.76(h)(1)(iii) to state that if a hospice
verifies during an on-site visit the finding of a supervising nurse
regarding an area of concern in the performance of a hospice aide, the
hospice must conduct and the hospice aide must complete a competency
evaluation related to the deficient and related skill(s), in accordance
with Sec. 418.76(c).
In section III.F of this rule, we discuss proposals to the HQRP
including the addition of claims-based Hospice Care Index (HCI)
measure, and Hospice Visits in the Last Days of Life (HVLDL) measure
for public reporting; removal of the seven Hospice Item Set (HIS)
measures because a more broadly applicable measure, the NQF 3235 HIS
Comprehensive Assessment Measure for the particular topic is available
and already publicly reported; and further development of, Hospice
Outcome and Patient Evaluation (HOPE) assessment instrument. We also
provide updates on the public reporting change for one refresh cycle to
report less than the standard quarters of data due to the COVID-19 PHE
exemptions and adding the Consumer Assessment of Healthcare Providers
and Systems (CAHPS[supreg]) Hospice Survey Star ratings. Additionally,
there are requests for information (RFI) on advancing to digital
quality measurement and the use of Fast Healthcare Interoperability
Resources (FHIR) and on addressing the White House Executive Order
related to health equity in the HQRP. In addition, this rule provides
updates to advancing Health Information Exchange (HIE). The Department
of Health and Human Services (HHS) has a number of initiatives designed
to encourage and support the adoption of interoperable health
information technology and to promote nationwide health information
exchange to improve health care and patient access to their health
information.
Finally, in section III.G of this rule, we are proposing changes to
the HH QRP to establish that, beginning with the January 2022 through
the July 2024 public reporting refresh cycle, we will report fewer
quarters of data due to COVID-19 PHE exceptions granted on March 27,
2020. We include this Home Health proposal in this rule because we plan
to resume public reporting for the HH QRP with the January 2022 refresh
of Care Compare. In order to accommodate the exception of 2020 Q1 and
Q2 data, we are proposing to resume public reporting using 3 out of 4
quarters of data for the January 2022 refresh. In order to finalize
this proposal in time to release the required preview report related to
the refresh, which we release 3 months prior to any given refresh
(October 2021), we need the rule containing this proposal to finalize
by October 2021.
C. Summary of Impacts
The overall economic impact of this proposed rule is estimated to
be $530 million in increased payments to hospices for FY 2022.
II. Background
A. Hospice Care
Hospice care is a comprehensive, holistic approach to treatment
that recognizes the impending death of a terminally ill individual and
warrants a change in the focus from curative care to palliative care
for relief of pain and for symptom management. Medicare regulations
define ``palliative care'' as patient and family-centered care that
optimizes quality of life by anticipating, preventing, and treating
suffering. Palliative care throughout the continuum of illness involves
addressing physical, intellectual, emotional, social, and spiritual
needs and to facilitate patient autonomy, access to information, and
choice (42 CFR 418.3). Palliative care is at the core of hospice
philosophy and care practices, and is a critical component of the
Medicare hospice benefit.
The goal of hospice care is to help terminally ill individuals
continue life with minimal disruption to normal activities while
remaining primarily in the home environment. A hospice uses an
interdisciplinary approach to deliver medical, nursing, social,
psychological, emotional, and spiritual services through a
collaboration of professionals and other caregivers, with the goal of
making the beneficiary as physically and emotionally comfortable as
possible. Hospice is compassionate beneficiary and family/caregiver-
centered care for those who are terminally ill.
As referenced in our regulations at Sec. 418.22(b)(1), to be
eligible for Medicare hospice services, the patient's attending
physician (if any) and the hospice medical director must certify that
the individual is ``terminally ill,'' as defined in section
1861(dd)(3)(A) of the Act and our regulations at Sec. 418.3; that is,
the individual has a medical prognosis that his or her life expectancy
is 6 months or less if the illness runs its normal course. The
regulations at Sec. 418.22(b)(2) require that clinical information and
other documentation that support the medical prognosis accompany the
certification and be filed in the medical record with it and those at
Sec. 418.22(b)(3) require that the certification and recertification
forms include a brief narrative explanation of the clinical findings
that support a life expectancy of 6 months or less.
Under the Medicare hospice benefit, the election of hospice care is
a patient choice and once a terminally ill patient elects to receive
hospice care, a hospice interdisciplinary group is essential in the
seamless provision of primarily home-based services. The hospice
interdisciplinary group works with the beneficiary, family, and
caregivers to develop a coordinated, comprehensive care plan; reduce
unnecessary diagnostics or ineffective therapies; and maintain ongoing
communication with individuals and their families about changes in
their condition. The beneficiary's care plan will shift over time to
meet the changing needs of the individual, family, and caregiver(s) as
the individual approaches the end of life.
If, in the judgment of the hospice interdisciplinary team, which
includes the hospice physician, the patient's symptoms cannot be
effectively managed at home, then the patient is eligible for general
inpatient care (GIP), a more medically intense level of care. GIP must
be provided in a Medicare-certified hospice freestanding facility,
skilled nursing facility, or hospital. GIP is provided to ensure that
any new or worsening symptoms are intensively addressed so that the
beneficiary can return to his or her home and continue to receive
routine home care. Limited, short-term, intermittent, inpatient respite
care (IRC) is also available because of the absence or need for relief
of the family or other caregivers. Additionally, an individual can
receive continuous home care (CHC) during a period of crisis in which
an individual requires continuous care to achieve palliation or
management of acute medical symptoms so that the
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individual can remain at home. Continuous home care may be covered for
as much as 24 hours a day, and these periods must be predominantly
nursing care, in accordance with the regulations at Sec. 418.204. A
minimum of 8 hours of nursing care, or nursing and aide care, must be
furnished on a particular day to qualify for the continuous home care
rate (Sec. 418.302(e)(4)).
Hospices must comply with applicable civil rights laws,\1\
including section 504 of the Rehabilitation Act of 1973 and the
Americans with Disabilities Act, under which covered entities must take
appropriate steps to ensure effective communication with patients and
patient care representatives with disabilities, including the
provisions of auxiliary aids and services. Additionally, they must take
reasonable steps to ensure meaningful access for individuals with
limited English proficiency, consistent with Title VI of the Civil
Rights Act of 1964. Further information about these requirements may be
found at: http://www.hhs.gov/ocr/civilrights.
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\1\ Hospices are also subject to additional Federal civil rights
laws, including the Age Discrimination Act, Section 1557 of the
Affordable Care Act, and conscience and religious freedom laws.
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B. Services Covered by the Medicare Hospice Benefit
Coverage under the Medicare hospice benefit requires that hospice
services must be reasonable and necessary for the palliation and
management of the terminal illness and related conditions. Section
1861(dd)(1) of the Act establishes the services that are to be rendered
by a Medicare-certified hospice program. These covered services
include: Nursing care; physical therapy; occupational therapy; speech-
language pathology therapy; medical social services; home health aide
services (called hospice aide services); physician services; homemaker
services; medical supplies (including drugs and biologicals); medical
appliances; counseling services (including dietary counseling); short-
term inpatient care in a hospital, nursing facility, or hospice
inpatient facility (including both respite care and procedures
necessary for pain control and acute or chronic symptom management);
continuous home care during periods of crisis, and only as necessary to
maintain the terminally ill individual at home; and any other item or
service which is specified in the plan of care and for which payment
may otherwise be made under Medicare, in accordance with Title XVIII of
the Act.
Section 1814(a)(7)(B) of the Act requires that a written plan for
providing hospice care to a beneficiary who is a hospice patient be
established before care is provided by, or under arrangements made by,
the hospice program; and that the written plan be periodically reviewed
by the beneficiary's attending physician (if any), the hospice medical
director, and an interdisciplinary group (section 1861(dd)(2)(B) of the
Act). The services offered under the Medicare hospice benefit must be
available to beneficiaries as needed, 24 hours a day, 7 days a week
(section 1861(dd)(2)(A)(i) of the Act).
Upon the implementation of the hospice benefit, the Congress also
expected hospices to continue to use volunteer services, though
Medicare does not pay for these volunteer services (section
1861(dd)(2)(E) of the Act). As stated in the FY 1983 Hospice Wage Index
and Rate Update proposed rule (48 FR 38149), the hospice must have an
interdisciplinary group composed of paid hospice employees as well as
hospice volunteers, and that ``the hospice benefit and the resulting
Medicare reimbursement is not intended to diminish the voluntary spirit
of hospices.'' This expectation supports the hospice philosophy of
community based, holistic, comprehensive, and compassionate end of life
care.
C. Medicare Payment for Hospice Care
Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of
the Act, and the regulations in 42 CFR part 418, establish eligibility
requirements, payment standards and procedures; define covered
services; and delineate the conditions a hospice must meet to be
approved for participation in the Medicare program. Part 418, subpart
G, provides for a per diem payment based on one of four prospectively-
determined rate categories of hospice care (RHC, CHC, IRC, and GIP),
based on each day a qualified Medicare beneficiary is under hospice
care (once the individual has elected). This per diem payment is meant
to cover all of the hospice services and items needed to manage the
beneficiary's care, as required by section 1861(dd)(1) of the Act.
While payments made to hospices is to cover all items, services,
and drugs for the palliation and management of the terminal illness and
related conditions, Federal funds cannot be used for the prohibited
activities, even in the context of a per diem payment. While recent
news reports \2\ have brought to light the potential role hospices
could play in medical aid in dying (MAID) where such practices have
been legalized in certain states, we wish to remind hospices that The
Assisted Suicide Funding Restriction Act of 1997 (Pub. L. 105-12)
prohibits the use of Federal funds to provide or pay for any health
care item or service or health benefit coverage for the purpose of
causing, or assisting to cause, the death of any individual including
mercy killing, euthanasia, or assisted suicide. However, the
prohibition does not pertain to the provision of an item or service for
the purpose of alleviating pain or discomfort, even if such use may
increase the risk of death, so long as the item or service is not
furnished for the specific purpose of causing or accelerating death.
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\2\ Nelson, R., Should Medical Aid in Dying Be Part of Hospice
Care? Medscape Nurses. February 26, 2020. https://www.medscape.com/viewarticle/925769#vp_1.
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1. Omnibus Budget Reconciliation Act of 1989
Section 6005(a) of the Omnibus Budget Reconciliation Act of 1989
(Pub. L. 101-239) amended section 1814(i)(1)(C) of the Act and provided
changes in the methodology concerning updating the daily payment rates
based on the hospital market basket percentage increase applied to the
payment rates in effect during the previous Federal fiscal year.
2. Balanced Budget Act of 1997
Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L.
105-33) established that updates to the hospice payment rates beginning
FY 2002 and subsequent FYs be the hospital market basket percentage
increase for the FY. Section 4442 of the BBA amended section 1814(i)(2)
of the Act, effective for services furnished on or after October 1,
1997, to require that hospices submit claims for payment for hospice
care furnished in an individual's home only on the basis of the
geographic location at which the service is furnished. Previously,
local wage index values were applied based on the geographic location
of the hospice provider, regardless of where the hospice care was
furnished. Section 4443 of the BBA amended sections 1812(a)(4) and
1812(d)(1) of the Act to provide for hospice benefit periods of two 90-
day periods, followed by an unlimited number of 60-day periods.
3. FY 1998 Hospice Wage Index Final Rule
The FY 1998 Hospice Wage Index final rule (62 FR 42860),
implemented a new methodology for calculating the
[[Page 19703]]
hospice wage index and instituted an annual Budget Neutrality
Adjustment Factor (BNAF) so aggregate Medicare payments to hospices
would remain budget neutral to payments calculated using the 1983 wage
index.
4. FY 2010 Hospice Wage Index Final Rule
The FY 2010 Hospice Wage Index and Rate Update final rule (74 FR
39384) instituted an incremental 7-year phase-out of the BNAF beginning
in FY 2010 through FY 2016. The BNAF phase-out reduced the amount of
the BNAF increase applied to the hospice wage index value, but was not
a reduction in the hospice wage index value itself or in the hospice
payment rates.
5. The Affordable Care Act
Starting with FY 2013 (and in subsequent FYs), the market basket
percentage update under the hospice payment system referenced in
sections 1814(i)(1)(C)(ii)(VII) and 1814(i)(1)(C)(iii) of the Act are
subject to annual reductions related to changes in economy-wide
productivity, as specified in section 1814(i)(1)(C)(iv) of the Act.
In addition, sections 1814(i)(5)(A) through (C) of the Act, as
added by section 3132(a) of the Patient Protection and Affordable Care
Act (PPACA) (Pub. L. 111-148), required hospices to begin submitting
quality data, based on measures specified by the Secretary of the
Department of Health and Human Services (the Secretary), for FY 2014
and subsequent FYs. Since FY 2014, hospices that fail to report quality
data have their market basket percentage increase reduced by 2
percentage points. Note that with the passage of the Consolidated
Appropriations Act, 2021 (hereafter referred to as CAA 2021) (Pub. L.
116-260), the reduction changes to 4 percentage points beginning in FY
2024.
Section 1814(a)(7)(D)(i) of the Act, as added by section 3132(b)(2)
of the PPACA, required, effective January 1, 2011, that a hospice
physician or nurse practitioner have a face-to-face encounter with the
beneficiary to determine continued eligibility of the beneficiary's
hospice care prior to the 180th day recertification and each subsequent
recertification, and to attest that such visit took place. When
implementing this provision, the Centers for Medicare & Medicaid
Services (CMS) finalized in the FY 2011 Hospice Wage Index final rule
(75 FR 70435) that the 180th day recertification and subsequent
recertifications would correspond to the beneficiary's third or
subsequent benefit periods. Further, section 1814(i)(6) of the Act, as
added by section 3132(a)(1)(B) of the PPACA, authorized the Secretary
to collect additional data and information determined appropriate to
revise payments for hospice care and other purposes. The types of data
and information suggested in the PPACA could capture accurate resource
utilization, which could be collected on claims, cost reports, and
possibly other mechanisms, as the Secretary determined to be
appropriate. The data collected could be used to revise the methodology
for determining the payment rates for RHC and other services included
in hospice care, no earlier than October 1, 2013, as described in
section 1814(i)(6)(D) of the Act. In addition, CMS was required to
consult with hospice programs and the Medicare Payment Advisory
Commission (MedPAC) regarding additional data collection and payment
revision options.
6. FY 2012 Hospice Wage Index Final Rule
In the FY 2012 Hospice Wage Index final rule (76 FR 47308 through
47314) it was announced that beginning in 2012, the hospice aggregate
cap would be calculated using the patient-by-patient proportional
methodology, within certain limits. Existing hospices had the option of
having their cap calculated through the original streamlined
methodology, also within certain limits. As of FY 2012, new hospices
have their cap determinations calculated using the patient-by-patient
proportional methodology. If a hospice's total Medicare payments for
the cap year exceed the hospice aggregate cap, then the hospice must
repay the excess back to Medicare.
7. IMPACT Act of 2014
The Improving Medicare Post-Acute Care Transformation Act of 2014
(IMPACT Act) (Pub. L. 113-185) became law on October 6, 2014. Section
3(a) of the IMPACT Act mandated that all Medicare certified hospices be
surveyed every 3 years beginning April 6, 2015 and ending September 30,
2025. In addition, section 3(c) of the IMPACT Act requires medical
review of hospice cases involving beneficiaries receiving more than 180
days of care in select hospices that show a preponderance of such
patients; section 3(d) of the IMPACT Act contains a new provision
mandating that the cap amount for accounting years that end after
September 30, 2016, and before October 1, 2025 be updated by the
hospice payment percentage update rather than using the consumer price
index for urban consumers (CPI-U) for medical care expenditures.
8. FY 2015 Hospice Wage Index and Payment Rate Update Final Rule
The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR
50452) finalized a requirement that the Notice of Election (NOE) be
filed within 5 calendar days after the effective date of hospice
election. If the NOE is filed beyond this 5-day period, hospice
providers are liable for the services furnished during the days from
the effective date of hospice election to the date of NOE filing (79 FR
50474). As with the NOE, the claims processing system must be notified
of a beneficiary's discharge from hospice or hospice benefit revocation
within 5 calendar days after the effective date of the discharge/
revocation (unless the hospice has already filed a final claim) through
the submission of a final claim or a Notice of Termination or
Revocation (NOTR).
The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR
50479) also finalized a requirement that the election form include the
beneficiary's choice of attending physician and that the beneficiary
provide the hospice with a signed document when he or she chooses to
change attending physicians.
In addition, the FY 2015 Hospice Wage Index and Rate Update final
rule (79 FR 50496) provided background, described eligibility criteria,
identified survey respondents, and otherwise implemented the Hospice
Experience of Care Survey for informal caregivers. Hospice providers
were required to begin using this survey for hospice patients as of
2015.
Finally, the FY 2015 Hospice Wage Index and Rate Update final rule
required providers to complete their aggregate cap determination not
sooner than 3 months after the end of the cap year, and not later than
5 months after, and remit any overpayments. Those hospices that fail to
submit their aggregate cap determinations on a timely basis will have
their payments suspended until the determination is completed and
received by the Medicare contractor (79 FR 50503).
9. FY 2016 Hospice Wage Index and Payment Rate Update Final Rule
In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR
47142), CMS finalized two different payment rates for RHC: A higher per
diem base payment rate for the first 60 days of hospice care and a
reduced per diem base payment rate for subsequent days of hospice care.
CMS also finalized a service intensity add-on (SIA)
[[Page 19704]]
payment payable for certain services during the last 7 days of the
beneficiary's life. A service intensity add-on payment will be made for
the social worker visits and nursing visits provided by a registered
nurse (RN), when provided during routine home care in the last 7 days
of life. The SIA payment is in addition to the routine home care rate.
The SIA payment is provided for visits of a minimum of 15 minutes and a
maximum of 4 hours per day (80 FR 47172).
In addition to the hospice payment reform changes discussed, the FY
2016 Hospice Wage Index and Rate Update final rule implemented changes
mandated by the IMPACT Act, in which the cap amount for accounting
years that end after September 30, 2016 and before October 1, 2025
would be updated by the hospice payment update percentage rather than
using the CPI-U (80 FR 47186). In addition, we finalized a provision to
align the cap accounting year for both the inpatient cap and the
hospice aggregate cap with the FY for FY 2017 and thereafter. Finally,
the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47144)
clarified that hospices would have to report all diagnoses on the
hospice claim as a part of the ongoing data collection efforts for
possible future hospice payment refinements.
10. FY 2017 Hospice Wage Index and Payment Rate Update Final Rule
In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR
52160), CMS finalized several new policies and requirements related to
the HQRP. First, CMS codified the policy that if the National Quality
Forum (NQF) made non-substantive changes to specifications for HQRP
measures as part of the NQF's re-endorsement process, CMS would
continue to utilize the measure in its new endorsed status, without
going through new notice-and-comment rulemaking. CMS would continue to
use rulemaking to adopt substantive updates made by the NQF to the
endorsed measures adopted for the HQRP; determinations about what
constitutes a substantive versus non-substantive change would be made
on a measure-by-measure basis. Second, we finalized two new quality
measures for the HQRP for the FY 2019 payment determination and
subsequent years: Hospice Visits when Death is Imminent Measure Pair
and Hospice and Palliative Care Composite Process Measure-Comprehensive
Assessment at Admission (81 FR 52173). The data collection mechanism
for both of these measures is the Hospice Item Set (HIS), and the
measures were effective April 1, 2017. Regarding the CAHPS[supreg]
Hospice Survey, CMS finalized a policy that hospices that receive their
CMS Certification Number (CCN) after January 1, 2017 for the FY 2019
Annual Payment Update (APU) and January 1, 2018 for the FY 2020 APU
will be exempted from the Hospice CAHPS[supreg] requirements due to
newness (81 FR 52182). The exemption is determined by CMS and is for 1
year only.
11. FY 2020 Hospice Wage Index and Payment Rate Update Final Rule
In the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR
38484), we finalized rebased payment rates for CHC and GIP and set
those rates equal to their average estimated FY 2019 costs per day. We
also rebased IRC per diem rates equal to the estimated FY 2019 average
costs per day, with a reduction of 5 percent to the FY 2019 average
cost per day to account for coinsurance. We finalized the FY 2020
proposal to reduce the RHC payment rates by 2.72 percent to offset the
increases to CHC, IRC, and GIP payment rates to implement this policy
in a budget-neutral manner in accordance with section 1814(i)(6) of the
Act (84 FR 38496).
In addition, we finalized a policy to use the current year's pre-
floor, pre-reclassified hospital inpatient wage index as the wage
adjustment to the labor portion of the hospice rates. Finally, in the
FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38505), we
finalized modifications to the hospice election statement content
requirements at Sec. 418.24(b) by requiring hospices, upon request, to
furnish an election statement addendum effective beginning in FY 2021.
The addendum must list those items, services, and drugs the hospice has
determined to be unrelated to the terminal illness and related
conditions, increasing coverage transparency for beneficiaries under a
hospice election.
12. Consolidated Appropriations Act, 2021
Division CC, section 404 of the CAA 2021 amended section
1814(i)(2)(B) of the Act and extended the provision that currently
mandates the hospice cap be updated by the hospice payment update
percentage (hospital market basket update reduced by the multifactor
productivity adjustment) rather than the CPI-U for accounting years
that end after September 30, 2016 and before October 1, 2030. Prior to
enactment of this provision, the hospice cap update was set to revert
to the original methodology of updating the annual cap amount by the
CPI-U beginning on October 1, 2025. Division CC, section 407 of CAA
2021 revises section 1814(i)(5)(A)(i) to increase the payment reduction
for hospices who fail to meet hospice quality measure reporting
requirements from two percent to four percent beginning with FY 2024.
III. Provisions of the Proposed Rule
A. Hospice Utilization and Spending Patterns
CMS provides analysis as it relates to hospice utilization such as
Medicare spending, utilization by level of care, lengths of stay, live
discharge rates, and skilled visits during the last days of life using
the most recent, complete claims data. Stakeholders report that such
data can be used to educate hospices on Medicare policies to help
ensure compliance. Moreover, in response to the Office of Inspector
General (OIG) reports highlighting vulnerabilities in the Medicare
hospice benefit including hospices engaging in inappropriate billing,
not providing needed services and crucial information to beneficiaries
in order for them to make informed decisions about their care, \3\ we
continue to monitor both hospice and non-hospice spending during a
hospice election. We are still analyzing the effects of the COVID-19
PHE as it relates to the following routine monitoring analysis and
whether those effects are likely to be temporary or permanent and if
such effects vary significantly across hospice providers. Therefore,
for the purposes of providing routine analysis on utilization and
spending, in this proposed rule, we used the most complete data we have
from FY 2019.
---------------------------------------------------------------------------
\3\ ``Hospice Inappropriately Billed Medicare Over $250 Million
for General Inpatient Care'', OEI-02-10-00491, March, 2016.
``Vulnerabilities in the Medicare Hospice Program Affect Quality
Care and Program Integrity: An OIG Portfolio'', OEI-02-16-00570,
July, 2018.
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1. General Hospice Utilization Trends
Since the implementation of the hospice benefit in 1983, there has
been substantial growth in hospice utilization. The number of Medicare
beneficiaries receiving hospice services has grown from 584,438 in FY
2001 to over 1.6 million in FY 2019. Medicare hospice expenditures have
risen from $3.5 billion in FY 2001 to approximately $20 billion in FY
2019.\4\ CMS' Office of the Actuary (OACT) projects that aggregate
hospice expenditures are expected to continue to increase, by
approximately 7.6 percent annually. We note that the
[[Page 19705]]
average spending per beneficiary has also increased between FY 2010 and
FY 2019 from approximately $11,158 in FY 2010 to $12,687 in FY 2019.\5\
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\4\ Source: Analysis of data for FY 2001 through FY 2019
accessed from the Chronic Conditions Data Warehouse (CCW) on January
15, 2021.
\5\ Source: Analysis of data for FY 2010 through FY 2019
accessed from the CCW on Jan 15, 2021.
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The percentage of Medicare decedents who died while receiving
services under the Medicare hospice benefit has increased as shown in
Table 1.
[GRAPHIC] [TIFF OMITTED] TP14AP21.000
Similar to the increase in the number of beneficiaries using the
benefit, the total number of organizations offering hospice services
also continues to grow, with for-profit providers entering the market
at higher rates than not-for-profit providers. In its March 2020 Report
to the Congress, MedPAC stated that for more than a decade, the
increasing number of hospice providers is due almost entirely to the
entry of for-profit providers. MedPAC also stated that long stays in
hospice have been very profitable and this has attracted new provider
entrants with revenue-generating strategies specifically targeting
those patients expected to have longer lengths of stay.\6\ Freestanding
hospices continue to dominate the market as a whole. In FY 2019, 68
percent (3,254 out of 4,811) of hospices were for-profit and 21 percent
(987 out of 4,811) were non-profit, whereas in FY 2014, 61 percent
(2,513 out of 4,108) were for-profit and 25 percent (1,029 out of
4,108) of hospices were non-profit. In FY 2019, for-profit hospices
provided approximately 58 percent of all hospice days while non-profit
hospices provided 31 percent of all hospice days.\7\ Hospices that
listed their ownership status as ``Other'', ``Government'' or had an
unknown ownership status accounted for the remaining percentage of
hospice days.
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\6\ Report to Congress, Medicare Payment Policy. Hospice
Services, Chapter 12. MedPAC. March 2020. http://www.medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
\7\ Source: FY 2014-FY 2019 hospice claims data from CCW on
January 15, 2021. December 2020 Provider of Service (POS) File
(https://www.cms.gov/files/zip/posothercsvdec19.zip).
Notes: Using the Analytic file, we found there were 4,971
hospices that submitted at least one claim in FY 2019. Of those, we
show the frequency of their ownership type as shown in the POS file.
For-profit hospices include the ``proprietary'' categories. Non-
profit includes the ``voluntary non-profit'' categories. Government
includes the ``Government'' categories and the ``Combination
Government & Nonprofit'' option. Other represents the ``other''
category. One hospice could not be linked to the POS file and is
listed as unknown.
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There have been notable changes in the pattern of diagnoses among
Medicare hospice enrollees since the implementation of the Medicare
hospice benefit from primarily cancer diagnoses to neurological
diagnoses, including Alzheimer's disease and other related dementias
(80 FR 25839). Our ongoing analysis of diagnosis reporting finds that
neurological and organ-based failure conditions remain the top-reported
principal diagnoses. Beneficiaries with these terminal conditions tend
to have longer hospice stays, which have historically been more
profitable than shorter stays.\8\ Table 2 shows the top 20 most
frequently reported principal diagnoses on FY 2019 hospice claims.
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\8\ Report to Congress, Medicare Payment Policy. Hospice
Services, Chapter 12. MedPAC. March 2020. http://www.medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
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Hospice Utilization by Level of Care
Our analysis shows that there have only been slight changes over
time in how hospices have been utilizing the different levels of care.
RHC consistently represents the highest percentage of total hospice
days as well as the highest percentage of total hospice payments as
shown in Tables 3 and 4).
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In the FY 2020 Hospice Wage Index and Payment Rate Update final
rule (84 FR 38496), we rebased the payment rates for the CHC, IRC, and
GIP levels of care to better align hospice payment with the costs of
providing care. We will continue to monitor the effects of these
rebased rates to determine if there are any notable shifts in the
provision of care or any other perverse utilization patterns that would
warrant any program integrity or survey actions.
2. Trends in Hospice Length of Stay, Live Discharges and Skilled Visits
in the Last Days of Life Analysis
Eligibility under the Medicare hospice benefit is predicated on the
individual being certified as terminally ill. Medicare regulations at
Sec. 418.3 define ``terminally ill'' to mean that the individual has a
medical prognosis that his or her life expectancy is 6 months or less
if the illness runs its normal course. However, we recognize that a
beneficiary may be under a hospice election longer than 6 months, as
long as there remains a reasonable expectation that the individuals
have a life expectancy of 6 months or less. It has always been our
expectation that the certifying physicians will use their best clinical
judgment, in accordance with the regulations at Sec. Sec. 418.22 and
418.25, to determine if the individual has a life expectancy of 6
months or less with each certification and recertification.
Hospice Length of Stay
We examined hospice length of stay in three ways: (1) Average
length of election, meaning the number of hospice days during a single
hospice election at the time of live discharge or death; (2) the median
lifetime length of stay, which represents the 50th percentile, and; (3)
average lifetime length of stay, which includes the sum of all days of
hospice care across all hospice elections. Extremely long lengths of
stay influence both the average length of election and average lifetime
length of stay. Table 5 shows the average length of election, the
median and average lifetime lengths of stay from FYs 2016 through 2019.
[GRAPHIC] [TIFF OMITTED] TP14AP21.005
Length of stay estimates vary based on the reported principal
diagnosis Table 6 lists the top six clinical categories of principal
diagnoses reported on hospice claims in FY 2019 along with the
corresponding number of hospice discharges. Patients with neurological
and organ-based failure conditions (with the exception of kidney
disease/kidney failure) tend to have much longer lengths of stay
compared to patients with cancer diagnoses.
[[Page 19708]]
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Hospice Live Discharges
Federal regulations limit the circumstances in which a Medicare
hospice provider may discharge a patient from its care. In accordance
with Sec. 418.26, discharge from hospice care is permissible when the
patient moves out of the provider's service area, is determined to be
no longer terminally ill, or for cause. Hospices may not discharge the
patient at their discretion, even if the care may be costly or
inconvenient for the hospice. Additionally, an individual or
representative may revoke the individual's election of hospice care at
any time during an election period in accordance with the regulations
at Sec. 418.28. However, at any time thereafter, the beneficiary may
re-elect hospice coverage at any other hospice election period that
they are eligible to receive. Immediately upon hospice revocation,
Medicare coverage resumes for those Medicare benefits previously waived
with the hospice election. Only the beneficiary (or representative) can
revoke the hospice election. A revocation must be in writing and must
specify the effective date of the revocation. A hospice cannot revoke a
beneficiary's hospice election, nor is it appropriate for hospices to
encourage, request, or demand that the beneficiary or his or her
representative revoke his or her hospice election.
From FY 2014 through FY 2019, the average live discharge rate has
been approximately 17 percent per year. Of the live discharges in FY
2019, 37.5 percent were because of revocations, 37.2 percent were
because the beneficiary was determined to no longer be terminally ill,
10.7 percent were because beneficiaries moved out of the service area
without transferring hospices, and 12.9 percent were because
beneficiaries transferred to another hospice (see Figure 1). The
remaining 1.6 percent were discharged for cause.\9\ Figure 1 shows the
average annual rates of live discharge rates from FYs 2010 through
2019.
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\9\ For cause is defined in Chapter 9, Section 20.2.3 of the
Hospice Benefit Policy Manual. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c09.pdf.
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[[Page 19709]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.007
Finally, we looked at the distribution of live discharges by length
of stay intervals. Figure 2 shows the live discharge rates by length of
stay intervals from FY 2016 through FY 2019. We found that the majority
of live discharges occur in the first 30 days of hospice care and after
180 days of hospice care. The proportion of live discharges occurring
between the lengths of stay intervals was relatively constant from FY
2016 to FY 2019 where approximately 25 percent of live discharges
occurred within 30 days of the start of hospice care, and approximately
32 percent occurred after a length of stay over 180 days of hospice
care.
[[Page 19710]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.008
Service Intensity Add-On (SIA) Payment
A hospice's costs typically follow a U-shaped curve, with higher
costs at the beginning and end of a stay, and lower costs in the middle
of the stay. This cost curve reflects hospices' higher service
intensity at the time of the patient's admission and the time
surrounding the patient's death.\10\ In the period immediately
preceding death, patient needs typically surge and more intensive
services are typically warranted, and where the provision of care would
proportionately escalate to meet the increased clinical, emotional, and
other needs of the hospice beneficiary and his or her family and
caregiver(s).
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\10\ Reforming Medicare's Hospice Benefit. MedPAC. March 2009.
http://www.medpac.gov/docs/default-source/reports/Mar09_Ch06.pdf?sfvrsn=0.
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In the FY 2016 Hospice Rate Update final rule (80 FR 47142), we
established two different payment rates for RHC to reflect the cost of
providing hospice care throughout the course of a hospice election. We
finalized a higher base payment rate for the first 60 days of hospice
care and a reduced base payment rate for days 61 and later. (80 FR
47172). To reflect higher costs associated with the last 7 days of
life, in FY 2016, we implemented the service intensity add-on payment
(SIA) for RHC when direct patient care is provided by a RN or social
worker during the last 7 of the beneficiary's life. The SIA payment is
equal to the CHC hourly rate multiplied by the hours of nursing or
social work provided on the day of service (up to 4 hours), if certain
criteria are met (80 FR 47177). This effort represented meaningful
advances in encouraging visits to hospice beneficiaries during the time
preceding death and where patient and family needs typically intensify.
To examine the effects of the SIA payment, we analyzed claims since
the implementation of the SIA payment to determine if there was an
increase in RN and social worker visits in the last seven days of life.
In CY 2015 (the year preceding the SIA payment), the percentage of
beneficiaries who did not receive a skilled nursing or social worker
visit on the last day of life (when the last day of life was RHC) was
nearly 23 percent. Our analysis shows a slight decline in the number of
beneficiaries who did not receive an RN or social worker visit on the
last day of life (when the last day of life was RHC) where the
percentage trended downward to just over 19 percent in CYs 2017 to
2019. This trend is similar for the 4 days leading up to the end of
life (when the last 4 days of life were RHC), meaning beneficiaries are
receiving more skilled nursing and social worker visits during the last
days of life since implementation of the SIA payment. Table 7 shows the
percentage of decedents not receiving skilled visits at the end of life
for CY 2015 through CY 2019.
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[[Page 19711]]
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SIA payments have increased from FY 2016 through FY 2019 from $88
million to $150 million respectively as shown in Figure 3.
[[Page 19712]]
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To further evaluate the impact of the SIA, we examined the total
amount of minutes provided by skilled nurses and social workers in the
last 7 days of life and overall there were only modest changes from CY
2015 to CY 2019, as shown in Table 8.\11\ MedPAC had examined skilled
nurse and social worker minutes in the last 7 days of life from CY 2015
through 2018 in their March 2020 Report to Congress and similarly found
little change overall.\12\
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\11\ Note: The SIA technically only applies to registered nurses
and non-telephonic social worker visits. The distinction was not
widely possible in the claims data prior to the SIA's
implementation. For the analyses in this section we examine all
skilled nurse and social worker visits, broadly.
\12\ Report to Congress, Medicare Payment Policy. Hospice
Services, Chapter 12. MedPAC. March 2020. http://www.medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
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[[Page 19713]]
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3. Non-Hospice Spending During a Hospice Election
The Medicare hospice per diem payment amounts were developed to
cover all services needed for the palliation and management of the
terminal illness and related conditions, as described in section
1861(dd)(1) of the Act. Hospice services provided under a written plan
of care (POC) should reflect patient and family goals and interventions
based on the problems identified in the initial, comprehensive, and
updated comprehensive assessments. As referenced in our regulations at
Sec. 418.64 and section II.B of this rule, a hospice must routinely
provide all core services directly by hospice employees and they must
be provided in a manner consistent with acceptable standards of
practice. Under the current payment system, hospices are paid for each
day that a beneficiary is enrolled in hospice care, regardless of
whether services are rendered on any given day.
Additionally, when a beneficiary elects the Medicare hospice
benefit, he or she waives the right to Medicare payment for services
related to the treatment of the terminal illness and related
conditions, except for services provided by the designated hospice and
the attending physician. The comprehensive nature of the services
covered under the Medicare hospice benefit is structured such that
hospice beneficiaries should not have to routinely seek items,
services, and/or medications beyond those provided by hospice. We
believe that it would be unusual and exceptional to see services
provided outside of hospice for those individuals who are approaching
the end of life and we have reiterated since 1983 that ``virtually
all'' care needed by the terminally ill individual would be provided by
the hospice.
In examining overall non-hospice spending during a hospice
election, Medicare paid over $1 billion in non-hospice spending during
a hospice election in FY 2019 for items and services under Parts A, B,
and D. Medicare payments for non-hospice Part A and Part B items and
services received by hospice beneficiaries during a hospice election
increased from $583 million in FY 2016 to $692 million in FY 2019 (see
Figure 4). This represents an increase in non-hospice Medicare spending
for Parts A and B of 18.7 percent. Whereas there is minimal beneficiary
cost sharing under the Medicare hospice benefit,\13\ non-hospice
services received outside of the Medicare hospice benefit are subject
to beneficiary cost sharing. In FY 2019, the total beneficiary cost
sharing amount was $170 million for Parts A and B.\14\
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\13\ The amount of coinsurance for each prescription
approximates 5 percent of the cost of the drug or biological to the
hospice determined in accordance with the drug copayment schedule
established by the hospice, except that the amount of coinsurance
for each prescription may not exceed $5. The amount of coinsurance
for each respite care day is equal to 5 percent of the payment made
by CMS for a respite care.
\14\ Part A and B cost sharing is calculated by summing together
the deductible and coinsurance amounts for each claim.
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We also examined non-hospice spending during a hospice election by
claim type for Parts A and B, as shown in Table 9.
[[Page 19715]]
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Hospices are responsible for covering drugs and biologicals related
to the palliation and management of the terminal illness and related
conditions while the patient is under hospice care. For a prescription
drug to be covered under Part D for an individual enrolled in hospice,
the drug must be for treatment completely unrelated to the terminal
illness or related conditions. After a hospice election, many
maintenance drugs or drugs used to treat or cure a condition are
typically discontinued as the focus of care shifts to palliation and
comfort measures. However, those same drugs may be appropriate to
continue as they may offer symptom relief for the palliation and
management of the terminal prognosis.\15\ Similar to the increase in
non-hospice spending during a hospice election for Medicare Parts A and
B items and services, non-hospice spending for Part D drugs increased
in from $353 million in FY 2016 to $499 million in FY 2019 (Figure 5).
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\15\ Update on Part D Payment Responsibility for Drugs for
Beneficiaries Enrolled in Medicare Hospice. November 2016. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/2016-11-15-Part-D-Hospice-Guidance.pdf.
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[[Page 19716]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.014
Analysis of Part D prescription drug events (PDEs) data suggests
that the current use of prior authorization (PA) by Part D sponsors has
reduced Part D program payments for drugs in four targeted categories
(analgesics, anti-nauseants, anti-anxiety, and laxatives), which are
typically used to treat common symptoms experienced during the end of
life. However, under Medicare Part D there has been an increase in
hospice beneficiaries filling prescriptions for a separate category of
drugs we refer to as maintenance drugs (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/2016-11-15-Part-D-Hospice-Guidance.pdf). Under CMS's current policy, Part D sponsors are
not expected to place hospice PA requirements on categories of drugs
(other than the four targeted categories listed above) or take special
measures beyond their normal compliance and utilization review
activities. Under this policy, sponsors are not expected to place PA
requirements on maintenance drugs, for beneficiaries under a hospice
election, though these drugs may still be subject to standard Part D
formulary management practices. This policy was put in place in
recognition of the operational challenges associated with requiring PA
on all drugs for beneficiaries who have elected hospice and because of
the potential barriers to access that could be created by requiring PA
on all drugs.\16\ Examples of maintenance drugs are those used to treat
high blood pressure, heart disease, asthma and diabetes. These
categories include beta blockers, calcium channel blockers,
corticosteroids, and insulin.
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\16\ Part D Payment for Drugs for Beneficiaries Enrolled in
Medicare Hospice. July 18, 2014. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/2014-PartD-Hospice-Guidance-Revised-Memo.pdf.
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Table 10 details the various components of Part D spending for
patients receiving hospice care for FY 2019. The portion of the FY 2019
Part D spending that was paid by Medicare is the sum of the Low Income
Cost-Sharing Subsidy and the Covered Drug Plan Paid Amount,
approximately $499 million. The beneficiary cost sharing amount was
approximately $59 million.\17\
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\17\ Part D cost sharing is calculated by summing together the
``the patient pay amount'' and the ``other true out of pocket''
amount that are recorded on the Part D PDE.
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[[Page 19717]]
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Comment Solicitation on Analysis of Hospice Utilization and Spending
Patterns
We are soliciting comments on all aspects of the analysis presented
in this proposed rule regarding hospice utilization and spending
patterns. Our ongoing monitoring and analysis have shown that the
hospice benefit has evolved; originally providing services primarily to
patients with cancer, to now primarily patients with neurological
conditions and organ-based failure. We are particularly interested in
how this change in patient characteristics may have influenced any
changes in the provision of hospice services. As mentioned in the above
analysis, after the implementation of the SIA in FY 2016, the number of
beneficiaries who did not receive an RN or social worker visit on the
last day of has decreased. We are soliciting comments regarding skilled
visits in the last week of life, particularly, what factors determine
how and when visits are made as an individual approaches the end of
life.
Given the comprehensive and holistic nature of the services covered
under the Medicare hospice benefit, we continue to expect that hospices
are providing virtually all of the care needed by terminally ill
individuals. However, the analysis of non-hospice spending during a
hospice election indicates a continuing trend where there is a
potential ``unbundling'' of items, services, and drugs from the
Medicare hospice benefit. That is, there may be items, services, and
drugs that should be covered under the Medicare hospice benefit but are
being paid under other Medicare benefits. We are soliciting comments as
to how hospices make determinations as to what items, services and
drugs are related versus unrelated to the terminal illness and related
conditions. That is, how do hospices define what is unrelated to the
terminal illness and related conditions when establishing a hospice
plan of care. Likewise, we are soliciting comments on what other
factors may influence whether or how certain services are furnished to
hospice beneficiaries. Finally, we are interested in stakeholder
feedback as to whether the hospice election statement addendum has
changed the way hospices make care decisions and how the addendum is
used to prompt discussions with beneficiaries and non-hospice providers
to ensure that the care needs of beneficiaries who have elected the
hospice benefit are met.
B. FY 2022 Proposed Labor Shares
1. Background
The labor share for CHC and RHC of 68.71 percent was established
with the FY 1984 Hospice benefit implementation based on the wage/
nonwage proportions specified in Medicare's limit on home health agency
costs (48 FR 38155 through 38156). The labor shares for IRC and GIP are
currently 54.13 percent and 64.01 percent, respectively. These
proportions were based on skilled nursing facility wage and nonwage
cost limits and skilled nursing facility costs per day (48 FR 38155
through 38156; 56 FR 26917).
For the FY 2022 proposed rule, we are proposing to rebase and
revise the labor shares for CHC, RHC, IRC and GIP using MCR data for
freestanding hospices (CMS Form 1984-14, OMB NO. 0938-0758 \18\) for
2018. We are proposing to continue to establish separate labor shares
for CHC, RHC, IRC, and GIP and base them on the calculated compensation
cost weights for each level of care from the 2018 MCR data. We describe
our proposed methodology for deriving the compensation cost weights for
each level of care using the MCR data below. We note that we did
explore the possibility of using facility-based hospice MCR data to
calculate the compensation cost weights; however, very few providers
passed the Level I edits (as described in more detail below) and so
these reports were not usable.
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\18\ Hospice Facility Cost Report. https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-1984-14.
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1. Proposed Methodology for Calculating Compensation Costs
We are proposing to derive a compensation cost weight for each
level of care that consists of five major components: (1) Direct
patient care salaries and contract labor costs, (2) direct patient care
benefits costs, (3) other patient care salaries, (4) overhead salaries,
and (5) overhead benefits costs. For each level of care, we are
proposing to use the same methodology to derive the components;
however, for the (1)
[[Page 19718]]
direct patient care salaries and (3) other patient care salaries, we
are proposing to use the MCR worksheet that is specific to that level
of care (that is, Worksheet A-1 for CHC, Worksheet A-2 for RHC,
Worksheet A-3 for IRC, and Worksheet A-4 for GIP).
(1) Direct Patient Care Salaries and Contract Labor Costs
Direct patient care salaries and contract labor costs are costs
associated with medical services provided by medical personnel
including but not limited to physician services, nurse practitioners,
registered nurses, and hospice aides. We are proposing to define direct
patient care salaries and contract labor costs to be equal to costs
reported on Worksheet A-1 (for CHC) or Worksheet A-2 (for RHC) or
Worksheet A-3 (for IRC) or Worksheet A-4 (for GIP), column 7, for lines
26 through 37.
(2) Direct Patient Care Benefits Costs
We are proposing that direct patient care benefits costs for CHC
would be equal to Worksheet B, column 3, line 50, for RHC are equal to
Worksheet B, column 3, line 51, for IRC are equal to Worksheet B,
column 3, line 52, and for GIP are equal to Worksheet B, column 3, line
53.
(3) Other Patient Care Salaries
Other patient care salaries are those salaries attributable to
patient services including but not limited to patient transportation,
labs, and imaging services. These salaries, reflecting all levels of
care, are reported on Worksheet A, column 1, lines 38 through 46 and
then are further disaggregated for CHC, RHC, IRC, and GIP on Worksheets
A-1, A-2, A-3, and A-4, respectively, on column 1 (salaries), lines 38
through 46. Our analysis, however, found that many providers were not
reporting salaries on the detailed level of care worksheets (A-1, A-2,
A-3, A-4, column 1), but rather reporting total costs (reflecting
salary and non-salary costs) for these services for each level of care
on Worksheets A-1, A-2, A-3, A-4, column 7. Therefore, we are proposing
to estimate other patient care salaries attributable to CHC, RHC, IRC,
and GIP by first calculating the ratio of total facility (reflecting
all levels of care) other patient care salaries (Worksheet A, column 1,
lines 38 through 46) to total facility other patient care total costs
(Worksheet A, column 7, lines 38 through 46). For CHC, we are proposing
to then multiply this ratio by other patient care total costs for CHC
(Worksheet A-1 column 7, lines 38 through 46). For RHC, we are
proposing to multiply this ratio by total other patient care costs for
RHC (Worksheet A-2, column 7, lines 38 through 46). For IRC, we are
proposing to multiply this ratio by total other patient care costs for
IRC (Worksheet A-3, column 7, lines 38 through 46). For GIP, we are
proposing to multiply this ratio by total other patient care costs for
GIP (Worksheet A-4, column 7, lines 38 through 46). This proposed
methodology assumes that the proportion of salary costs to total costs
for other patient care services is consistent for each of the four
levels of care.
(4) Overhead Salaries
The MCR captures total overhead costs (including but not limited to
administrative and general, plant operations and maintenance, and
housekeeping) attributable to each of the four levels of care. To
estimate overhead salaries for each level of care, we first propose to
calculate noncapital non-benefit overhead costs for each level of care
to be equal to Worksheet B, column 18, less the sum of Worksheet B,
columns 0 through 3, for line 50 (CHC), or line 51 (RHC) or line 52
(IRC) or line 53 (GIP). We then are proposing to multiply these non-
capital non-benefit overhead costs for each level of care times the
ratio of total facility overhead salaries (Worksheet A, column 1, lines
4 through 16) to total facility non-capital non-benefit overhead costs
(which is equal to Worksheet B, column 18 (total costs), line 101 less
the sum of Worksheet B, columns 0 (direct patient care costs), column 1
(fixed capital), column 2 (moveable capital) and column 3 (employee
benefits), line 101).
(5) Overhead Benefits Costs
To estimate overhead benefits costs for each level of care, we are
proposing a similar methodology to overhead salaries. For each level of
care, we are proposing to calculate noncapital overhead costs for each
level of care to be equal to Worksheet B, column 18, less the sum of
Worksheet B, columns 0 through 2, for line 50 (CHC), or line 51 (RHC)
or line 52 (IRC) or line 53 (GIP). We then are proposing to multiply
these non-capital overhead costs for each level of care times the ratio
of total facility overhead benefits (Worksheet B, column 3, lines 4
through 16) to total facility noncapital overhead costs (Worksheet B,
column 18, line 101 less the sum of Worksheet B, columns 0 through 2,
line 101). This proposed methodology assumes the ratio of total
overhead benefit costs to total noncapital overhead costs is consistent
among all four levels of care.
(6) Total Compensation Costs and Total Costs
To calculate the compensation costs for each provider, we are
proposing to then sum each of the costs estimated in steps (1) through
(5) to derive total compensation costs for CHC, RHC, IRC, and GIP. We
are proposing that total costs for CHC are equal to Worksheet B, column
18, line 50, for RHC are equal to Worksheet B, column 18, line 51, for
IRC would be equal to Worksheet B, column 18, line 52, and for GIP are
equal to Worksheet B, column 18, line 53.
2. Proposed Methodology for Deriving Compensation Cost Weights
To derive the compensation cost weights for each level of care, we
first are proposing to begin with a sample of providers who met new
Level I edit conditions that required freestanding hospices to fill out
certain parts of their cost reports effective for freestanding hospice
cost reports with a reporting period that ended on or after December
31, 2017.\19\ Specifically, we required the following costs to be
greater than zero: Fixed capital costs (Worksheet B, column 0, line 1),
movable capital costs (Worksheet B, column 0, line 2), employee
benefits (Worksheet B, column 0, line 3), administrative and general
(Worksheet B, column 0, line 4), volunteer service coordination
(Worksheet B, column 0, line 13), pharmacy and drugs charged to
patients (sum of Worksheet B, column 0, line 14 and Worksheet A, column
7, line 42.50), registered nurse costs (Worksheet A, column 7, line
28), medical social service costs (Worksheet A, column 7, line 33),
hospice aide and homemaker services costs (Worksheet A, column 7, line
37), and durable medical equipment (Worksheet A, column 7, line 38).
Applying these Level I edits to the 2018 freestanding hospice MCRs
resulted in 3,345 providers that passed the edits (four were excluded).
---------------------------------------------------------------------------
\19\ Medicare Department of Health and Human Services (DHHS)
Provider Reimbursement Manual--Part 2, Provider Cost Reporting Forms
and Instructions, Chapter 43, Form CMS-1984-14. April 13, 2018.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3P243.pdf.
---------------------------------------------------------------------------
Then, for each level of care separately, we are proposing to
further trim the sample of MCRs. We outline our proposed trimming
methodology using CHC as an example. Specifically, for CHC, we propose
that total CHC costs (Worksheet B, column 18, line 50) and CHC
compensation costs to be greater than zero. We also propose that CHC
direct patient care salaries and contract labor costs per day would be
greater
[[Page 19719]]
than 1. We also propose to exclude those providers whose CHC
compensation costs were greater than total CHC costs.
For the IRC and GIP compensation cost weights, we are proposing to
only use those MCRs from providers that provided inpatient services in
their facility. Therefore, we are proposing to exclude providers that
reported costs greater than zero on Worksheet A-3, column 7, line 25
(Inpatient Care--Contracted) for IRC and Worksheet A-4, column 7, line
25 (Inpatient Care--Contracted) for GIP. The facilities that remained
after this trim reported detailed direct patient care costs and other
patient care costs for which we could then derive direct patient care
salaries and other patient care salaries per the methodology described
earlier. This additional trim resulted in a sample that consists of
approximately 20 percent of IRP providers and 28 percent of GIP
providers that passed both the Level I edits and the trims that
required total costs and compensation costs to be greater than zero,
and direct patient care salaries and contract labor costs per day to be
greater than 1, as well as total costs to be greater than compensation
costs.
Finally, to derive the proposed compensation cost weights for each
level of care for each provider, we are proposing to divide
compensation costs for each level of care by total costs for each level
of care. We are proposing to then trim the data for each level of care
separately to remove outliers. Following our example for CHC, we are
proposing to simultaneously remove those providers whose total CHC
costs per day fall in the top and bottom one percent of total CHC costs
per day for all CHC providers as well remove those providers whose
compensation cost weight falls in the top and bottom five percent of
compensation cost weights for all CHC providers. We then sum the CHC
compensation costs and total CHC costs of the remaining providers,
yielding a proposed compensation cost weight for CHC.
Since we have to limit our sample for IRC and GIP compensation cost
weights to those hospices providing inpatient services in their
facility, we conducted sensitivity analysis to test for the
representative of this sample by reweighting compensation cost weights
using data from the universe of freestanding providers that reported
either IRC or GIP total costs. For example, we calculated reweighted
compensation cost weights by ownership-type (proprietary, government
and nonprofit), by size (based on RHC days) and by region. Our
reweighted compensation cost weights for IRC and GIP were similar (less
than one percentage point in absolute terms) to our proposed
compensation cost weights for IRC and GIP (as shown in Table 11) and,
therefore, we believe our sample is representative of freestanding
hospices providing inpatient hospice care.
Table 11 provides the proposed labor share for each level of care
based on the compensation cost weights we derived using our proposed
methodology described previously. We are proposing the labor shares be
equal to three decimal places consistent with the labor shares used in
other Prospective Payment Systems (PPS) (such as the inpatient
prospective payment system (IPPS) and the Home Health Agency PPS). We
invite comments on our proposed methodology to derive the labor shares
for each level of care.
[GRAPHIC] [TIFF OMITTED] TP14AP21.016
C. Proposed Routine FY 2022 Hospice Wage Index and Rate Update
1. Proposed FY 2022 Hospice Wage Index
The hospice wage index is used to adjust payment rates for hospices
under the Medicare program to reflect local differences in area wage
levels, based on the location where services are furnished. The hospice
wage index utilizes the wage adjustment factors used by the Secretary
for purposes of section 1886(d)(3)(E) of the Act for hospital wage
adjustments. Our regulations at Sec. 418.306(c) require each labor
market to be established using the most current hospital wage data
available, including any changes made by the Office of Management and
Budget (OMB) to the Metropolitan Statistical Areas (MSAs) definitions.
In general, OMB issues major revisions to statistical areas every
10 years, based on the results of the decennial census. However, OMB
occasionally issues minor updates and revisions to statistical areas in
the years between the decennial censuses. On March 6, 2020, OMB issued
Bulletin No. 20-01, which provided updates to and superseded OMB
Bulletin No. 18-04 that was issued on September 14, 2018. The
attachments to OMB Bulletin No. 20-01 provided detailed information on
the update to statistical areas since September 14, 2018, and were
based on the application of the 2010 Standards for Delineating
Metropolitan and Micropolitan Statistical Areas to Census Bureau
population estimates for July 1, 2017 and July 1, 2018. (For a copy of
this bulletin, we refer readers to the following website: https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf). In
OMB Bulletin No. 20-01, OMB announced one new Micropolitan Statistical
Area, one new component of an existing Combined Statistical Are and
changes to New England City and Town Area (NECTA) delineations. In the
FY 2021 Hospice Wage Index final rule (85 FR 47070) we stated that if
appropriate, we would propose any updates from OMB Bulletin No. 20-01
in future rulemaking. After reviewing OMB Bulletin No. 20-01, we have
determined that the changes in Bulletin 20-01 encompassed delineation
changes
[[Page 19720]]
that would not affect the Medicare wage index for FY 2022.
Specifically, the updates consisted of changes to NECTA delineations
and the redesignation of a single rural county into a newly created
Micropolitan Statistical Area. The Medicare wage index does not utilize
NECTA definitions, and, as most recently discussed in the FY 2021
Hospice Wage Index final rule (85 FR 47070), we include hospitals
located in Micropolitan Statistical areas in each state's rural wage
index. Therefore, while we are proposing to adopt the updates set forth
in OMB Bulletin No. 20-01 consistent with our longstanding policy of
adopting OMB delineation updates, we note that specific wage index
updates would not be necessary for FY 2022 as a result of adopting
these OMB updates. In other words, these OMB updates would not affect
any geographic areas for purposes of the wage index calculation for FY
2022.
In the FY 2020 Hospice Wage Index final rule (84 FR 38484), we
finalized the proposal to use the current FY's hospital wage index data
to calculate the hospice wage index values. In the FY 2021 Hospice Wage
Index final rule (85 FR 47070), we finalized the proposal to adopt the
revised OMB delineations with a 5 percent cap on wage index decreases,
where the estimated reduction in a geographic area's wage index would
be capped at 5 percent in FY 2021 and no cap would be applied to wage
index decreases for the second year (FY 2022). For FY 2022, the
proposed hospice wage index would be based on the FY 2022 hospital pre-
floor, pre-reclassified wage index for hospital cost reporting periods
beginning on or after October 1, 2017 and before October 1, 2018 (FY
2018 cost report data). The proposed FY 2022 hospice wage index would
not include a cap on wage index decreases and would not take into
account any geographic reclassification of hospitals, including those
in accordance with section 1886(d)(8)(B) or 1886(d)(10) of the Act. The
appropriate wage index value is applied to the labor portion of the
hospice payment rate based on the geographic area in which the
beneficiary resides when receiving RHC or CHC. The appropriate wage
index value is applied to the labor portion of the payment rate based
on the geographic location of the facility for beneficiaries receiving
GIP or IRC.
In the FY 2006 Hospice Wage Index final rule (70 FR 45135), we
adopted the policy that, for urban labor markets without a hospital
from which hospital wage index data could be derived, all of the Core-
Based Statistical Areas (CBSAs) within the state would be used to
calculate a statewide urban average pre-floor, pre-reclassified
hospital wage index value to use as a reasonable proxy for these areas.
For FY 2022, the only CBSA without a hospital from which hospital wage
data can be derived is 25980, Hinesville-Fort Stewart, Georgia. The FY
2022 adjusted wage index value for Hinesville-Fort Stewart, Georgia is
0.8649.
There exist some geographic areas where there were no hospitals,
and thus, no hospital wage data on which to base the calculation of the
hospice wage index. In the FY 2008 Hospice Wage Index final rule (72 FR
50217 through 50218), we implemented a methodology to update the
hospice wage index for rural areas without hospital wage data. In cases
where there was a rural area without rural hospital wage data, we use
the average pre-floor, pre-reclassified hospital wage index data from
all contiguous CBSAs, to represent a reasonable proxy for the rural
area. The term ``contiguous'' means sharing a border (72 FR 50217).
Currently, the only rural area without a hospital from which hospital
wage data could be derived is Puerto Rico. However, for rural Puerto
Rico, we would not apply this methodology due to the distinct economic
circumstances that exist there (for example, due to the close proximity
to one another of almost all of Puerto Rico's various urban and non-
urban areas, this methodology would produce a wage index for rural
Puerto Rico that is higher than that in half of its urban areas);
instead, we would continue to use the most recent wage index previously
available for that area. For FY 2022, we propose to continue to use the
most recent pre-floor, pre-reclassified hospital wage index value
available for Puerto Rico, which is 0.4047, subsequently adjusted by
the hospice floor.
As described in the August 8, 1997 Hospice Wage Index final rule
(62 FR 42860), the pre-floor and pre-reclassified hospital wage index
is used as the raw wage index for the hospice benefit. These raw wage
index values are subject to application of the hospice floor to compute
the hospice wage index used to determine payments to hospices. As
previously discussed, the adjusted pre-floor, pre-reclassified hospital
wage index values below 0.8 will be further adjusted by a 15 percent
increase subject to a maximum wage index value of 0.8. For example, if
County A has a pre-floor, pre-reclassified hospital wage index value of
0.3994, we would multiply 0.3994 by 1.15, which equals 0.4593. Since
0.4593 is not greater than 0.8, then County A's hospice wage index
would be 0.4593. In another example, if County B has a pre-floor, pre-
reclassified hospital wage index value of 0.7440, we would multiply
0.7440 by 1.15, which equals 0.8556. Because 0.8556 is greater than
0.8, County B's hospice wage index would be 0.8. The proposed hospice
wage index applicable for FY 2022 (October 1, 2021 through September
30, 2022) is available on our website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index.html.
2. Proposed FY 2022 Hospice Payment Update Percentage
Section 4441(a) of the BBA (Pub. L. 105-33) amended section
1814(i)(1)(C)(ii)(VI) of the Act to establish updates to hospice rates
for FYs 1998 through 2002. Hospice rates were to be updated by a factor
equal to the inpatient hospital market basket percentage increase set
out under section 1886(b)(3)(B)(iii) of the Act, minus 1 percentage
point. Payment rates for FYs since 2002 have been updated according to
section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update
to the payment rates for subsequent FYs must be the inpatient market
basket percentage increase for that FY. CMS currently uses 2014-based
IPPS operating and capital market baskets to update the market basket
percentage. In the FY 2022 IPPS proposed rule \20\ CMS is proposing to
rebase and revise the IPPS market baskets to reflect a 2018 base year.
We refer stakeholders to the FY 2022 IPPS proposed rule for further
information.
---------------------------------------------------------------------------
\20\ IPPS Regulations and Notices. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/IPPS-Regulations-and-Notices.
---------------------------------------------------------------------------
Section 3401(g) of the Affordable Care Act mandated that, starting
with FY 2013 (and in subsequent FYs), the hospice payment update
percentage would be annually reduced by changes in economy-wide
productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act.
The statute defines the productivity adjustment to be equal to the 10-
year moving average of changes in annual economy-wide private nonfarm
business multifactor productivity (MFP).
The proposed hospice payment update percentage for FY 2022 is based
on the current estimate of the proposed inpatient hospital market
basket update of 2.5 percent (based on IHS Global Inc.'s fourth-quarter
2020 forecast with historical data through the third quarter 2020). Due
to the requirements at sections 1886(b)(3)(B)(xi)(II) and
1814(i)(1)(C)(v) of the Act, the proposed inpatient hospital market
basket update
[[Page 19721]]
for FY 2022 of 2.5 percent must be reduced by a MFP adjustment as
mandated by Affordable Care Act (currently estimated to be 0.2
percentage points for FY 2022). In effect, the proposed hospice payment
update percentage for FY 2022 would be 2.3 percent. If more recent data
becomes available after the publication of this proposed rule and
before the publication of the final rule (for example, more recent
estimates of the inpatient hospital market basket update and MFP
adjustment), we would use such data, if appropriate, to determine the
hospice payment update percentage for FY 2022 in the final rule.
Currently, the labor portion of the hospice payment rates are as
follows: For RHC, 68.71 percent; for CHC, 68.71 percent; for GIP, 64.01
percent; and for IRC, 54.13 percent. As discussed in section III.B of
this proposed rule, we are proposing to rebase and revise the labor
shares for RHC, CHC, GIP and IRC using MCR data for freestanding
hospices (CMS Form 1984-14, OMB Control Number 0938-0758) for 2018. We
are proposing the labor portion of the payment rates to be: For RHC,
64.7 percent; for CHC, 74.6 percent; for GIP, 62.8 percent; and for
IRC, 60.1 percent. The non-labor portion is equal to 100 percent minus
the labor portion for each level of care. Therefore, we are proposing
the non-labor portion of the payment rates to be as follows: For RHC,
35.3 percent; for CHC, 25.4 percent; for GIP, 37.2 percent; and for
IRC, 39.9 percent.
3. Proposed FY 2022 Hospice Payment Rates
There are four payment categories that are distinguished by the
location and intensity of the hospice services provided. The base
payments are adjusted for geographic differences in wages by
multiplying the labor share, which varies by category, of each base
rate by the applicable hospice wage index. A hospice is paid the RHC
rate for each day the beneficiary is enrolled in hospice, unless the
hospice provides CHC, IRC, or GIP. CHC is provided during a period of
patient crisis to maintain the patient at home; IRC is short-term care
to allow the usual caregiver to rest and be relieved from caregiving;
and GIP is to treat symptoms that cannot be managed in another setting.
As discussed in the FY 2016 Hospice Wage Index and Rate Update
final rule (80 FR 47172), we implemented two different RHC payment
rates, one RHC rate for the first 60 days and a second RHC rate for
days 61 and beyond. In addition, in that final rule, we implemented a
SIA payment for RHC when direct patient care is provided by an RN or
social worker during the last 7 days of the beneficiary's life. The SIA
payment is equal to the CHC hourly rate multiplied by the hours of
nursing or social work provided (up to 4 hours total) that occurred on
the day of service, if certain criteria are met. In order to maintain
budget neutrality, as required under section 1814(i)(6)(D)(ii) of the
Act, the new RHC rates were adjusted by a service intensity add-on
budget neutrality factor (SBNF). The SBNF is used to reduce the overall
RHC rate in order to ensure that SIA payments are budget-neutral. At
the beginning of every FY, SIA utilization is compared to the prior
year in order calculate a budget neutrality adjustment.
In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR
52156), we initiated a policy of applying a wage index standardization
factor to hospice payments in order to eliminate the aggregate effect
of annual variations in hospital wage data. Typically, the wage index
standardization factor is calculated using the most recent, complete
hospice claims data available. However, due to the COVID-19 PHE, we
looked at using the previous fiscal year's hospice claims data (FY
2019) to determine if there were significant differences between
utilizing 2019 and 2020 claims data. The difference between using FY
2019 and FY 2020 hospice claims data was minimal. Therefore, we will
continue our practice of using the most recent, complete hospice claims
data available; that is we are using FY 2020 claims data for the FY
2022 payment rate updates. In order to calculate the wage index
standardization factor, we simulate total payments using FY 2020
hospice utilization claims data with the FY 2021 wage index (pre-floor,
pre-reclassified hospital wage index with the hospice floor, and a 5
percent cap on wage index decreases) and FY 2021 payment rates (that
include the current labor shares) and compare it to our simulation of
total payments using the FY 2022 hospice wage index (with hospice
floor, without the 5 percent cap on wage index decreases) and FY 2021
payment rates (that include the current labor shares). By dividing
payments for each level of care (RHC days 1 through 60, RHC days 61+,
CHC, IRC, and GIP) using the FY 2021 wage index and payment rates for
each level of care by the FY 2022 wage index and FY 2021 payment rates,
we obtain a wage index standardization factor for each level of care.
In order to calculate the labor share standardization factor we
simulate total payments using FY 2020 hospice utilization claims data
with the FY 2022 hospice wage index and the current labor shares and
compare it to our simulation of total payments using the FY 2022
hospice wage index with the proposed revised labor shares. The wage
index and labor share standardization factors for each level of care
are shown in the Tables 12 and 13.
The proposed FY 2022 RHC rates are shown in Table 12. The proposed
FY 2022 payment rates for CHC, IRC, and GIP are shown in Table 13.
[GRAPHIC] [TIFF OMITTED] TP14AP21.017
[[Page 19722]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.018
Sections 1814(i)(5)(A) through (C) of the Act require that hospices
submit quality data, based on measures to be specified by the
Secretary. In the FY 2012 Hospice Wage Index and Rate Update final rule
(76 FR 47320 through 47324), we implemented a HQRP as required by those
sections. Hospices were required to begin collecting quality data in
October 2012, and submit that quality data in 2013. Section
1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014 and
each subsequent FY, the Secretary shall reduce the market basket update
by 2 percentage points for any hospice that does not comply with the
quality data submission requirements with respect to that FY. The
proposed FY 2022 rates for hospices that do not submit the required
quality data would be updated by the proposed FY 2022 hospice payment
update percentage of 2.3 percent minus 2 percentage points. These rates
are shown in Tables 14 and 15.
[GRAPHIC] [TIFF OMITTED] TP14AP21.019
[[Page 19723]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.020
4. Proposed Hospice Cap Amount for FY 2022
As discussed in the FY 2016 Hospice Wage Index and Rate Update
final rule (80 FR 47183), we implemented changes mandated by the IMPACT
Act of 2014 (Pub. L. 113-185). Specifically, we stated that for
accounting years that end after September 30, 2016 and before October
1, 2025, the hospice cap is updated by the hospice payment update
percentage rather than using the CPI-U. Division CC, section 404 of the
CAA 2021 has extended the accounting years impacted by the adjustment
made to the hospice cap calculation until 2030. Therefore, for
accounting years that end after September 30, 2016 and before October
1, 2030, the hospice cap amount is updated by the hospice payment
update percentage rather than using the CPI-U. As a result of the
changes mandated by Division CC, section 404 of the CAA 2021, we are
proposing conforming regulation text changes at Sec. 418.309 to
reflect the new language added to section 1814(i)(2)(B) of the Act.
The proposed hospice cap amount for the FY 2022 cap year will be
$31,389.66, which is equal to the FY 2021 cap amount ($30,683.93)
updated by the proposed FY 2022 hospice payment update percentage of
2.3 percent.
D. Proposed Clarifying Regulation Text Changes for the Hospice Election
Statement Addendum
In the FY 2020 Hospice Wage Index and Payment Rate Update final
rule (84 FR 38484), we finalized modifications to the hospice election
statement content requirements at Sec. 418.24(b) to increase coverage
transparency for patients under a hospice election. These changes
included a new condition for payment requiring a hospice, upon request,
to provide the beneficiary (or representative) an election statement
addendum (hereafter called ``the addendum'') outlining the items,
services, and drugs that the hospice has determined are unrelated to
the terminal illness and related conditions. We stated in that final
rule that the addendum is intended to complement the Hospice Conditions
of Participation (CoPs) at Sec. 418.52(a), which require hospices to
verbally inform beneficiaries, at the time of hospice election, of the
services covered under the Medicare hospice benefit, as well as the
limitations of such services (84 FR 38509). The requirements at
Sec. Sec. 418.24(b) and 418.52(a) ensure that beneficiaries are aware
of any items, services, or drugs they would have to seek outside of the
benefit, as well as their potential out-of-pocket costs for hospice
care, such as co-payments and/or coinsurance.
Section 418.24(c) sets forth the elements that must be included on
the addendum:
1. The addendum must be titled ``Patient Notification of Hospice
Non-Covered Items, Services, and Drugs'';
2. Name of the hospice;
3. Beneficiary's name and hospice medical record identifier;
4. Identification of the beneficiary's terminal illness and related
conditions;
5. A list of the beneficiary's current diagnoses/conditions present
on hospice admission (or upon plan of care update, as applicable) and
the associated items, services, and drugs, not covered by the hospice
because they have been determined by the hospice to be unrelated to the
terminal illness and related conditions;
6. A written clinical explanation, in language the beneficiary and
his or her representative can understand, as to why the identified
conditions, items, services, and drugs are considered unrelated to the
terminal illness and related conditions and not needed for pain or
symptom management. This clinical explanation must be accompanied by a
general statement that the decision as to what conditions, items,
services, or drugs are unrelated is made for each individual patient,
and that the beneficiary should share this clinical explanation with
other health care providers from which he or she seeks services
unrelated to his or her terminal illness and related conditions;
7. References to any relevant clinical practice, policy, or
coverage guidelines;
8. Information on the following:
a. Purpose of the addendum
b. patient's right to immediate advocacy
9. Name and signature of the Medicare hospice beneficiary (or
representative) and date signed, along with a statement that signing
this addendum (or its updates) is only acknowledgement of receipt of
the addendum (or its updates) and not necessarily the beneficiary's
agreement with the hospice's determinations.
The hospice is required to furnish the addendum in writing in an
accessible format,\23\ so the beneficiary (or representative) can
understand the information provided, make treatment decisions based on
that information, and share such information with non-hospice providers
rendering un-related items and services to the beneficiary. Therefore,
the format of the addendum
[[Page 19724]]
must be usable for the beneficiary and/or representative. Although we
stated in the FY 2020 Hospice Wage Index and Payment Rate Update that
hospices may develop their own election statement addendum (84 FR
38507), we posted a modified model election statement and addendum on
the Hospice Center web page,\21\ along with the publication of the FY
2021 Hospice Wage Index and Payment Rate Update final rule (85 FR
47070). The intent was to provide an illustrative example as hospices
can modify and develop their own forms to meet the content
requirements. In the FY 2021 Hospice Wage Index and Payment Rate Update
final rule, we stated that most often we would expect the addendum
would be in a hard copy format the beneficiary or representative can
keep for his or her own records, similar to how hospices are required
by the hospice CoPs at Sec. 418.52(a)(3) to provide the individual a
copy of the notice of patient rights and responsibilities (85 FR
47091). The hospice CoPs at Sec. 418.104(a)(2) state that the
patient's record must include ``signed copies of the notice of patient
rights in accordance with Sec. 418.52.'' Likewise, since the addendum
is part of the election statement as set forth in Sec. 418.24(b)(6),
then it is required to be part of the patient's record (if requested by
the beneficiary or representative). The signed addendum is only
acknowledgement of the beneficiary's (or representative's) receipt of
the addendum (or its updates) and the payment requirement is considered
met if there is a signed addendum (and any signed updates) in the
requesting beneficiary's medical record with the hospice. We believe
that a signed addendum connotes that the hospice discussed the addendum
and its contents with the beneficiary (or representative).
Additionally, in the event that a beneficiary (or representative) does
not request the addendum, we expect hospices to document, in some
fashion, that an addendum has been discussed with the patient (or
representative) at the time of election, similar to how other patient
and family discussions are documented in the hospice's clinical record.
It is necessary for the hospice to document that the addendum was
discussed and whether or not it was requested, in order to prevent
potential claims denials related to any absence of an addendum (or
addendum updates) in the medical record.
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\23\ English and Spanish Version of the Hospice Addendum Model.
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice.
\21\ Hospice Center web page. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/index.
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Though we did not propose any changes to the election statement
addendum content requirements at Sec. 418.24(c), or the October 1,
2020 effective date, in the FY 2021 Hospice Wage Index and Payment Rate
Update proposed rule, we solicited comments on the usefulness of the
modified model election statement and addendum posted on the Hospice
Center web page (85 FR 20949). In the FY 2021 Hospice Wage Index and
Payment Rate Update final rule (85 FR 47093), we responded to comments
received, and stated that, as finalized in the FY 2020 Hospice Wage
Index and Payment Rate Update final rule, the hospice election
statement addendum will remain a condition for payment that is met when
there is a signed addendum (and its updates) in the beneficiary's
hospice medical record.
Since its implementation on October 1, 2020, CMS has received
additional inquiries from stakeholders asking for clarification on
certain aspects of the addendum. We appreciate and understand the
importance of provider input and involvement in ensuring that this
document is effective in increasing coverage transparency for
beneficiaries. Therefore, we are providing clarification on, and
proposing modifications to, certain signature and timing requirements
and proposing corresponding clarifying regulations text changes.
Currently the regulations at Sec. 418.24(c) require that if a
beneficiary or his or her representative requests the addendum at the
time of the initial hospice election (that is, at the time of admission
to hospice), the hospice must provide this information, in writing, to
the individual (or representative) within 5 days from the date of the
election. Hospices have reported that beneficiaries or representatives
sometimes do not request the addendum at the time of election, but
rather within the 5 days after the effective date of the election. In
these situations, the regulations require the hospice to provide the
addendum within 3 days, as the beneficiary requested the addendum
during the course of care. However, in accordance with Sec. 418.54(b),
the hospice interdisciplinary group (IDG), in consultation with the
individual's attending physician (if any), must complete the hospice
comprehensive assessment no later than 5 calendar days after the
election of hospice care. In some instances, this may mean that the
hospice must furnish the addendum prior to completion of the
comprehensive assessment. The comprehensive assessment includes all
areas of hospice care related to the palliation and management of a
beneficiary's terminal illness. This assessment is necessary because it
provides an overview of the items, services and drugs that the patient
is already utilizing as well as helps determine what the hospice may
need to add in order to treat the patient throughout the dying process.
If the addendum is completed prior to the comprehensive assessment, the
hospice may not have a complete patient profile, which could
potentially result in the hospice incorrectly anticipating the extent
of covered and non-covered services and lead to an inaccurate election
statement addendum. Hospice providers are only able to discern what
items, services, and drugs they will not cover once they have a
beneficiary's comprehensive assessment. We are proposing to allow the
hospice to furnish the addendum within 5 days from the date of a
beneficiary or representative request, if the request is within 5 days
from the date of a hospice election. For example, if the patient elects
hospice on December 1st and requests the addendum on December 3rd, the
hospice would have until December 8th to furnish the addendum.
Additionally, hospices have noted that there is not a timeframe in
regulations regarding the patient signature on the addendum. Section
418.24(c)(9) requires the beneficiary's signature (or his/her
representative's signature) as well as the date the document was
signed. We noted in the FY 2021 Hospice Wage Index & Payment Rate
Update final rule that because the beneficiary signature is an
acknowledgement of receipt of the addendum, this means the beneficiary
would sign the addendum when the hospice provides it, in writing, to
the beneficiary or representative (85 FR 47092). Additionally,
obtaining the required signatures on the election statement has been a
longstanding regulatory requirement. Therefore, we expect that hospices
already have processes and procedures in place to ensure that required
signatures are obtained, either from the beneficiary, or from the
representative in the event the beneficiary is unable to sign. We
anticipate that hospices would use the same procedures for obtaining
signatures on the addendum. However, we understand that some
beneficiaries or representatives may request an emailed addendum or
request more time to review the addendum before signing, in which case
the date that the hospice furnished the addendum to the beneficiary (or
representative) may differ from the date that the beneficiary
[[Page 19725]]
or representative signs the addendum. This means the hospice may
furnish the addendum within the required timeframe; however, the
signature date may be beyond the required timeframe. Therefore, we
propose to clarify in regulation that the ``date furnished'' must be
within the required timeframe (that is, 3 or 5 days of the beneficiary
or representative request, depending on when such request was made),
rather than the signature date. At Sec. 418.24(c)(10), we propose that
the hospice would include the ``date furnished'' in the patient's
medical record and on the addendum itself.
In the FY 2021 Hospice Wage Index and Payment Rate Update final
rule, we addressed a concern regarding a potential situation wherein
the beneficiary or representative refuses to sign the addendum (85 FR
47088). We reiterated that the signature on the addendum is only
acknowledgement of receipt and not a tacit agreement of its contents,
and that we expect the hospice to inform the beneficiary of the purpose
of the addendum and rationale for the signature. However, we recognized
that there might be rare instances in which the beneficiary (or
representative) refuses to sign the addendum. We noted that we would
consider whether this issue would require future rulemaking. We have
subsequently received this question from stakeholders post
implementation, therefore, in this proposed rule, we are clarifying
that if a patient or representative refuses to sign the addendum, the
hospice must document clearly in the medical record (and on the
addendum itself) the reason the addendum is not signed in order to
mitigate a claims denial for this condition for payment. In such a
case, although the beneficiary has refused to sign the addendum, the
``date furnished'' must still be within the required timeframe (that
is, within 3 or 5 days of the beneficiary or representative request,
depending on when such request was made), and noted in the chart and on
the addendum itself.
Stakeholders again requested that CMS clarify whether a non-hospice
provider is required to sign the addendum in the event that the non-
hospice provider requests the addendum rather than the beneficiary or
representative. Therefore, if only a non-hospice provider or Medicare
contractor requests the addendum (and not the beneficiary or
representative) we would not expect a signed copy in the patient's
medical record. Hospices can develop processes (including how to
document such requests from non-hospice providers and Medicare
contractors) to address circumstances in which the non-hospice provider
or Medicare contractor requests the addendum, and the beneficiary or
representative does not. As such, we are proposing to clarify in
regulation that if a non-hospice provider requests the addendum, rather
than the beneficiary or representative, the non-hospice provider is not
required to sign the addendum.
There may be instances in which the beneficiary or representative
requests the addendum and the beneficiary dies, revokes, or is
discharged prior to signing the addendum. While we stated in the FY
2020 Hospice Wage Index and Payment Rate Update final rule, that if the
beneficiary requests the election statement addendum at the time of
hospice election but dies within 5 days, the hospice would not be
required to furnish the addendum as the requirement would be deemed as
being met in this circumstance (84 FR 38521), this policy was not
codified in regulation. Therefore, we are proposing conforming
regulations text changes at Sec. 418.24(c) to reflect this policy.
Furthermore, we propose to clarify at Sec. 418.24(d)(4) that if the
patient revokes or is discharged within the required timeframe (3 or 5
days after a request, depending upon when such request was made), but
the hospice has not yet furnished the addendum, the hospice is not
required to furnish the addendum. Similarly, we are proposing to
clarify at Sec. 418.24(d)(5) that in the event that a beneficiary
requests the addendum and the hospice furnishes the addendum within 3
or 5 days (depending upon when the request for the addendum was made),
but the beneficiary dies, revokes, or is discharged prior to signing
the addendum, a signature from the individual (or representative) is no
longer required. We would continue to expect that the hospice would
note the date furnished in the patient's medical record and on the
addendum, if the hospice has already completed the addendum, as well as
an explanation in the patient's medical record noting that the patient
died, revoked, or was discharged prior to signing the addendum.
Finally, we are proposing conforming regulations text changes at
Sec. 418.24(c) in alignment with subregulatory guidance indicating
that hospices have ``3 days,'' rather than ``72 hours'' to meet the
requirement when a patient requests the addendum during the course of a
hospice election. Hospices must furnish the addendum no later than 3
calendar days after a beneficiary's (or representative's) request
during the course of a hospice election. This means that hospice
providers must furnish the addendum to the beneficiary or
representative on or before the third day after the date of the
request. For example, if a beneficiary (or representative) requests the
addendum on February 22nd, then the hospice will have until February
25th to furnish the addendum, regardless of what time the addendum was
requested on February 22nd. The intent of this clarification is to
better align with the requirement for furnishing an election statement
addendum when the addendum is requested within 5 days of the date of
election, which also uses ``days'' rather than ``hours''.
We are soliciting comments on these proposed clarifications and
conforming regulation text changes.
E. Hospice Waivers Made Permanent Conditions of Participation
1. Background
In order to support provider and supplier communities due to the
COVID-19 PHE, CMS has issued an unprecedented number of regulatory
waivers under our statutory authority set forth at section 1135 of the
Act. Under section 1135 of the Act, the Secretary may temporarily waive
or modify certain Medicare, Medicaid, and Children's Health Insurance
Program (CHIP) requirements to ensure that sufficient health care items
and services are available to meet the needs of individuals enrolled in
the programs in the emergency area and time periods, and that providers
who furnish such services in good faith, but who are unable to comply
with one or more requirements as described under section 1135(b) of the
Act, can be reimbursed and exempted from sanctions for violations of
waived provisions (absent any determination of fraud or abuse). The
intent of these waivers was to expand healthcare system capacity while
continuing to maintain public and patient safety, and to hold harmless
providers and suppliers unable to comply with existing regulations
after a good faith effort.
While some of these waivers simply delay certain administrative
deadlines, others directly affect the provision of patient care. The
utilization and application of these waivers pushed us to consider
whether permanent changes would be beneficial to patients, providers,
and professionals. We identified selected waivers as appropriate
candidates for formal regulatory changes. Those proposed changes and
their respective histories and background information are discussed in
detail in section II. E of this rule. We are also proposing regulatory
[[Page 19726]]
changes that are not directly related to PHE waivers but would clarify
or align some policies that have been raised as concerns by
stakeholders.
We are proposing the following revisions to the hospice Conditions
of Participation (CoPs).
2. Hospice Aide Training and Evaluation--Using Pseudo-Patients
Hospice aides deliver a significant portion of direct care. Aides
are usually trained by an employer, such as a hospice, home health
agency (HHA) or nursing home and may already be certified as an aide
prior to being hired. The competency of new aides must be evaluated by
the hospice to ensure appropriate care can be provided by the aide.
Aide competency evaluations should be conducted in a way that
identifies and meets training needs of the aide as well as the
patient's needs. These evaluations are a critical part of providing
safe, quality care. In September of 2019, we published a final rule
that allows the use of the pseudo-patient for conducting home health
aide competency evaluations (``Medicare and Medicaid Programs;
Regulatory Provisions To Promote Program Efficiency, Transparency, and
Burden Reduction; Fire Safety Requirements for Certain Dialysis
Facilities; Hospital and Critical Access Hospital (CAH) Changes To
Promote Innovation, Flexibility, and Improvement in Patient Care'' (84
FR 51732)). The ability to use pseudo-patients during aide competency
evaluations allows greater flexibility and may reduce burden on
suppliers. We believe that hospices and their patients would also
benefit from the ability to use pseudo-patients in aide training.
The current hospice aide competency standard regulations at Sec.
418.76(c)(1) requires the aide to be evaluated by observing an aide's
performance of the task with a patient. We propose to make similar
changes to hospice aide competency standards to those already made with
respect to HHAs (see Sec. 484.80(c)) in our hospice regulations at
Sec. 418.76(c)(1)), which describes the process for conducting hospice
aide competency evaluations, and propose to define both ``pseudo-
patient'' and ``simulation'' at Sec. 418.3. Thus, we are proposing to
permit skill competencies to be assessed by observing an aide
performing the skill with either a patient or a pseudo-patient as part
of a simulation. The proposed definitions are as follows:
``Pseudo-patient'' means a person trained to participate
in a role-play situation, or a computer-based mannequin device. A
pseudo-patient must be capable of responding to and interacting with
the hospice aide trainee, and must demonstrate the general
characteristics of the primary patient population served by the hospice
in key areas such as age, frailty, functional status, cognitive status
and care goals.
``Simulation'' means a training and assessment technique
that mimics the reality of the homecare environment, including
environmental distractions and constraints that evoke or replicate
substantial aspects of the real world in a fully interactive fashion,
in order to teach and assess proficiency in performing skills, and to
promote decision making and critical thinking.
These proposed changes would allow hospices to utilize pseudo-
patients, such as a person trained to participate in a role-play
situation or a computer-based mannequin device, instead of actual
patients, in the competency testing of hospice aides for those tasks
that must be observed being performed on a patient. This could increase
the speed of performing competency testing and would allow new aides to
begin serving patients more quickly while still protecting patient
health and safety.
3. Hospice Aid Training and Evaluation--Targeting Correction of
Deficiencies
We are also proposing to amend the requirement at Sec.
418.76(h)(1)(iii) to specify that if an area of concern is verified by
the hospice during the on-site visit, then the hospice must conduct,
and the hospice aide must complete, a competency evaluation of the
deficient skill and all related skill(s) in accordance with Sec.
418.76(c). This proposed change would permit the hospice to focus on
the hospice aides' specific deficient and related skill(s) instead of
completing another full competency evaluation. We believe when a
deficient area(s) in the aide's care is assessed by the RN, there may
be additional related competencies that may also lead to additional
deficient practice areas. For example, if a patient's family informed
the nurse that the patient almost fell when the aide was transferring
the patient to a chair; the nurse could assess the aide's transferring
technique to determine whether there was any improper form. The hospice
must also conduct, and the hospice aide must complete, a competency
evaluation related to the deficient and related transferring skills;
such as transferring from bed to bedside commode or shower chair.
We request public comment on our proposed changes to allow for the
use of the pseudo patient for conducting hospice aide competency
testing, and the proposed change to allow the hospice to focus on the
hospice aides' specific deficient skill(s) instead of completing a full
competency evaluation. We especially welcome comments from hospices
that implemented the use of pseudo-patients during the COVID-19 PHE and
the additional proposal, that if an area of concern is verified by the
hospice during the on-site visit, then the hospice must conduct, and
the hospice aide must complete, a competency evaluation related to the
deficient and related skill(s).
F. Proposals and Updates to the Hospice Quality Reporting Program
1. Background and Statutory Authority
The Hospice Quality Reporting Program (HQRP) specifies reporting
requirements for both the Hospice Item Set (HIS) and Consumer
Assessment of Healthcare Providers and Systems (CAHPS[supreg]) Hospice
Survey. Section 1814(i)(5) of the Act requires the Secretary to
establish and maintain a quality reporting program for hospices.
Section 1814(i)(5)(A)(i) of the Act was amended by section 407(b) of
Division CC, Title IV of the CAA 2021 (Pub. L. 116-260) to change the
payment reduction for failing to meet hospice quality reporting
requirements from 2 to 4 percentage points. This policy will apply
beginning with FY 2024 annual payment update (APU). Specifically, the
Act requires that, beginning with FY 2014 through FY 2023, the
Secretary shall reduce the market basket update by 2 percentage points
and beginning with the FY 2024 APU and for each subsequent year, the
Secretary shall reduce the market basket update by 4 percentage points
for any hospice that does not comply with the quality data submission
requirements for that FY.
In addition, section 407(a)(2) of the CAA 2021 removes the
prohibition on public disclosure of hospice surveys performed be a
national accreditation agency in section 1865(b) of the Act, thus
allowing the Secretary to disclose such accreditation surveys. In
addition, section 407(a)(1) of the CAA 2021 adds new requirements in
newly added section 1822(a)(2) to require each state and local survey
agency, and each national accreditation body with an approved hospice
accreditation program, to submit information respecting any survey or
certification made with respect to a hospice program. Such information
shall include any inspection report made by such survey agency or body
with respect to such survey or certification, any enforcement
[[Page 19727]]
actions taken as a result of such survey or certification, and any
other information determined appropriate by the Secretary. This
information will be published publicly on our website, such as Care
Compare, in a manner that is easily accessible, readily understandable,
and searchable no later than October 1, 2022. In addition, national
accreditation bodies with approved hospice accreditation programs
described above are required to use the same survey form used by state
and local survey agencies, which is currently the Form CMS-2567, on or
after October 1, 2021.
Depending on the amount of the annual update for a particular year,
a reduction of 2 percentage points through FY 2023 or 4 percentage
points beginning in FY 2024 could result in the annual market basket
update being less than zero percent for a FY and may result in payment
rates that are less than payment rates for the preceding FY. Any
reduction based on failure to comply with the reporting requirements,
as required by section 1814(i)(5)(B) of the Act, would apply only for
the specified year. Any such reduction would not be cumulative nor be
taken into account in computing the payment amount for subsequent FYs.
Section 1814(i)(5)(C) of the Act requires that each hospice submit
data to the Secretary on quality measures specified by the Secretary.
The data must be submitted in a form, manner, and at a time specified
by the Secretary. Any measures selected by the Secretary must have been
endorsed by the consensus-based entity which holds a performance
measurement contract with the Secretary under section 1890(a) of the
Act. This contract is currently held by the National Quality Forum
(NQF). However, section 1814(i)(5)(D)(ii) of the Act provides that in
the case of a specified area or medical topic determined appropriate by
the Secretary for which a feasible and practical measure has not been
endorsed by the consensus-based entity, the Secretary may specify
measures that are not endorsed, as long as due consideration is given
to measures that have been endorsed or adopted by a consensus-based
organization identified by the Secretary. Section 1814(i)(5)(D)(iii) of
the Act requires that the Secretary publish selected measures
applicable with respect to FY 2014 no later than October 1, 2012.
In the FY 2014 Hospice Wage Index and Payment Rate Update final
rule (78 FR 48234), and in compliance with section 1814(i)(5)(C) of the
Act, we finalized the specific collection of data items that support
the seven NQF-endorsed hospice measures described in Table 1. In
addition, we finalized the Hospice Visits When Death is Imminent
measure pair (HVWDII, Measure 1 and Measure 2) in the FY 2017 Hospice
Wage Index and Payment Rate Update final rule, effective April 1, 2017.
We refer the public to the FY 2017 Hospice Wage Index and Payment Rate
Update final rule (81 FR 52144) for a detailed discussion.
The CAHPS Hospice Survey is a component of the CMS HQRP, which is
used to collect data on the experiences of hospice patients and their
family caregivers listed in their hospice records. Readers who want
more information about the development of the survey, originally called
the Hospice Experience of Care Survey, may refer to 79 FR 50452 and 78
FR 48261. National implementation of the CAHPS Hospice Survey commenced
January 1, 2015, as stated in the FY 2015 Hospice Wage Index and
Payment Rate Update final rule (79 FR 50452).
The CAHPS Hospice Survey measures received NQF endorsement on
October 26, 2016 and was re-endorsed November 20, 2020 (NQF #2651). NQF
endorsed six composite measures and two overall measures from the CAHPS
Hospice Survey. Along with nine HIS-based quality measures, the CAHPS
Hospice Survey measures are publicly reported on a designated CMS
website that is currently Care Compare. Table 16 lists all quality
measures currently adopted for the HQRP.
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The Hospice and Palliative Care Composite Process Measure--HIS-
Comprehensive Assessment at Admission measure (hereafter referred to as
``the HIS Comprehensive Assessment Measure'') underwent an off-cycle
review by the NQF Palliative and End-of-Life Standing Committee and
successfully received NQF endorsement in July 2017 (NQF 3235). The HIS
Comprehensive Assessment Measure captures whether multiple key care
processes were delivered upon patients' admissions to hospice in one
measure as described in the Table 1. NQF 3235 does not require NQF's
endorsements of the previous components to remain valid. Thus, if the
components included in NQF 3235 do not individually maintain
endorsement, the endorsement status of NQF 3235, as a single measure,
will not change.
In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR
47142), we finalized the policy for retention of HQRP measures adopted
for previous payment determinations and seven factors for measure
removal. In that same final rule, we discussed that we will issue
public notice, through rulemaking, of measures under consideration for
removal, suspension, or replacement. However, if there is reason to
believe continued collection of a measure raises potential safety
concerns, we will take immediate action to remove the measure from the
HQRP and will not wait for the annual rulemaking cycle. Such measures
will be promptly removed and we will immediately notify hospices and
the public of our decision through the usual HQRP communication
channels, including but not limited to listening sessions, email
notification, Open Door Forums, HQRP Forums, and Web postings. In such
instances, the removal of a measure will be formally announced in the
next annual rulemaking cycle.
In the FY 2019 Hospice Wage Index and Rate Update final rule (83 FR
38622), we also adopted an eighth factor for removal of a measure. This
factor aims to promote improved health outcomes for beneficiaries while
minimizing the overall costs associated with the program. These costs
are multifaceted and include the burden associated with complying with
the program. The finalized reasons for removing quality measures are:
1. Measure performance among hospices is so high and unvarying that
meaningful distinctions in improvements in performance can no longer be
made;
2. Performance or improvement on a measure does not result in
better patient outcomes;
3. A measure does not align with current clinical guidelines or
practice;
4. A more broadly applicable measure (across settings, populations,
or conditions) for the particular topic is available;
5. A measure that is more proximal in time to desired patient
outcomes for the particular topic is available;
6. A measure that is more strongly associated with desired patient
outcomes for the particular topic is available;
7. Collection or public reporting of a measure leads to negative
unintended consequences; or
8. The costs associated with a measure outweighs the benefit of its
continued use in the program.
On August 31, 2020, we added correcting language to the FY 2016
Hospice Wage Index and Payment Rate Update and Hospice Quality
Reporting Requirements; Correcting Amendment (85 FR 53679) hereafter
referred to as the FY 2021 HQRP Correcting Amendment. In this final
rule, we made correcting amendments to 42 CFR 418.312 to correct
technical errors
[[Page 19730]]
identified in the FY 2016 Hospice Wage Index and Payment Rate Update
final rule. Specifically, the FY 2021 HQRP Correcting Amendment (85 FR
53679) adds paragraph (i) to Sec. 418.312 to reflect our exemptions
and extensions requirements, which were referenced in the preamble but
inadvertently omitted from the regulations text. Thus, these exemptions
or extensions can occur when a hospice encounters certain extraordinary
circumstances.
As stated in the FY 2019 Hospice Wage Index and Rate Update final
rule (83 FR 38622), we launched the Meaningful Measures initiative
(which identifies high priority areas for quality measurement and
improvement) to improve outcomes for patients, their families, and
providers while also reducing burden on clinicians and providers. More
information about the Meaningful Measures initiative can be found at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
In the FY 2020 Hospice Wage Index and Payment Rate Update final
rule (84 FR 38484), we discussed our interest in developing quality
measures using claims data, to expand data sources for quality measure
development. While we acknowledged in that rule the limitations with
using claims data as a source for measure development, there are
several advantages to using claims data as part of a robust HQRP as
discussed previously in the FY 2020 rule. We also discussed developing
the Hospice Outcomes & Patient Evaluation (HOPE), a new patient
assessment instrument that is planned to replace the HIS. See an update
on HOPE development in section III.F.6, Update regarding the Hospice
Outcomes & Patient Evaluation (HOPE) development.
We also discussed our interest in outcome quality measure
development. Unlike process measures, outcome measures capture the
results of care as experienced by patients, which can include aspects
of a patient's health status and their experiences in the health
system. The portfolio of quality measures in the HQRP will include
outcome measures that reflect the results of care.
2. Proposal To Remove the Seven ``Hospice Item Set Process Measures''
From HQRP Beginning FY 2022
In the FY 2014 Hospice Wage Index and Payment Rate Update final
rule (78 FR 48234), and in compliance with section 1814(i)(5)(C) of the
Act, we finalized the specific collection of standardized data items,
known as the HIS, that support the following NQF-endorsed measures:
NQF #1617 Patients Treated with an Opioid who are Given a
Bowel Regimen
NQF #1634 Pain Screening
NQF #1637 Pain Assessment
NQF #1638 Dyspnea Treatment
NQF #1639 Dyspnea Screening
NQF #1641 Treatment Preferences
NQF #1647 Beliefs/Values Addressed (if desired by the patient)
These measures were adopted to increase public awareness of key
components of hospice care, such as pain and symptom management and
non-clinical care needs. Consistent with our policy for measure
retention and removal, finalized in the FY 2016 Hospice Wage Index and
Rate Update final rule (80 FR 47142), we reviewed these measures
against the factors for removal. Our analysis found that they meet
factor 4: ``A more broadly applicable measure (across settings,
populations, or conditions) for the particular topic is available.'' We
determined that the NQF #3235 HIS Comprehensive Assessment Measure,
discussed in detail in the FY 2017 Hospice Wage Index and Payment Rate
Update final rule (81 FR 52144), is a more broadly applicable measure
and continues to provide, in a single measure, meaningful differences
between hospices regarding overall quality in addressing the physical,
psychosocial, and spiritual factors of hospice care upon admission.
The HIS Comprehensive Assessment Measure's ``all or none''
criterion requires hospices to perform all seven care processes in
order to receive credit. In this way, it is different from an average-
based composite measure and sets a higher bar for performance. This
single measure differentiates hospices and holds them accountable for
completing all seven process measures to ensure core services of the
hospice comprehensive assessment are completed for all hospice
patients. Therefore, the HIS Comprehensive Assessment Measure continues
to encourage hospices to improve and maintain high performance in all
seven processes simultaneously, rather than rely on its component
measures to demonstrate quality hospice care in a way that may be hard
to interpret for consumers. The individual measures show performance
for only one process and do not demonstrate whether the hospice
provides high-quality care overall, as an organization. For example, a
hospice may perform extremely well assessing treatment preferences, but
poorly on addressing pain. High-quality hospice care not only manages
pain and symptoms of the terminal illness, but assesses non-clinical
needs of the patient and family caregivers, which is a hallmark of
patient-centered care. Since the HIS Comprehensive Assessment Measure
captures all seven processes collectively, we believe that public
display of the individual component measures are not necessary.
The interdisciplinary, holistic scope of the NQF #3235 HIS
Comprehensive Assessment Measure aligns with the public's expectations
for hospice care. In addition, the measure supports alignment across
our programs and with other public and private initiatives. The seven
individual components address care processes around hospice admission
that are clinically recommended or required in the hospice CoPs. The
Medicare Hospice CoPs require that hospice comprehensive assessments
identify patients' physical, psychosocial, emotional, and spiritual
needs and address them to promote the hospice patient's comfort
throughout the end-of-life process. Furthermore, the person-centered,
family, and caregiver perspective align with the domains identified by
the CoPs and the National Consensus Project \22\ as patients and their
family caregivers also place value on physical symptom management and
spiritual/psychosocial care as important factors at the end-of-life.
The HIS Comprehensive Assessment Measure is a composite measure that
serves to ensure all hospice patients receive a comprehensive
assessment for both physical and psychosocial needs at admission.
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\22\ The National Consensus Project Guidelines expand on the
eight domains of palliative care in the 3rd edition and include
clinical and organizational strategies, screening and assessment
elements, practice examples, tools and resources. The guidelines
were developed by the National Consensus Project for Quality
Palliative Care, comprising 16 national organizations with extensive
expertise in and experience with palliative care and hospice, and
were published by the National Coalition for Hospice and Palliative
Care. Journal of Hospice & Palliative Nursing: December 2018--Volume
20--Issue 6--p 507.
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In addition, MedPAC's Report to Congress: Medicare Payment Policy
\23\ over the past few years notes that the HIS Comprehensive
Assessment Measure differentiates the hospice's overall ability to
address care processes better than the seven individual HIS process
measures. In this way, it provides consumers viewing data on Care
Compare with a streamlined way to
[[Page 19731]]
assess the extent to which a hospice follows care processes.
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\23\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
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We are not proposing any revisions to the HIS Comprehensive
Assessment Measure in this proposed rule because the single measure
continues to provide value to patients, their families, and providers.
Because the HIS Comprehensive Assessment Measure is a more broadly
applicable measure, we propose to remove the seven individual HIS
process measures from the HQRP, no longer publicly reporting them as
individual measures on Care Compare beginning with FY 2022. In
addition, we are proposing to remove the ``7 measures that make up the
HIS Comprehensive Assessment Measure'' section of Care Compare, which
displays the seven HIS measures. We propose to make these changes
removing the seven HIS process measures as individual measures from
HQRP no earlier than May 2022.
Although this proposal removes the seven individual HIS process
measures, it does not propose any changes to the requirement to submit
the HIS admission assessment. Since the HIS Comprehensive Assessment
Measure is a composite of the seven HIS process measures, the burden
and requirement to report the HIS data remain unchanged in the time,
manner, and form finalized in the FY 2017 Hospice Wage Index and Rate
Update final rule (81 FR 52144). Hospices which do not report HIS data
used for the HIS Comprehensive Assessment Measure will not meet the
requirements for compliance with the HQRP.
We are soliciting public comment on the proposal to remove the
seven HIS process quality measures as individual measures from the HQRP
no earlier than May 2022, and to continue including the seven HIS
process measures in the confidential quality measure (QM) Reports which
are available to hospices. The seven HIS process measures are also
available by visiting the data catalogue at https://data.cms.gov/provider-data/topics/hospice-care. We are also seeking public comment
on the technical correction to the regulation at Sec. 418.312(b)
effective October 1, 2021.
3. Proposal To Add a ``Claims-Based Index Measure'', the Hospice Care
Index
We are proposing a new hospice quality measure, called the Hospice
Care Index (HCI), which will provide more information to better reflect
several processes of care during a hospice stay, and better empower
patients and family caregivers to make informed health care decisions.
The HCI is a single measure comprising ten indicators calculated from
Medicare claims data. The index design of the HCI simultaneously
monitors all ten indicators. Collectively these indicators represent
different aspects of hospice service and thereby characterize hospices
comprehensively, rather than on just a single care dimension.
Therefore, the HCI composite yields a more reliable provider ranking.
The HCI indicators, through the composite, would add new
information to HQRP that was either directly recommended for CMS to
publicly report by Federal stakeholders 23 24 or identified
as areas for improvement during information gathering activities.
Furthermore, each indicator represents either a domain of hospice care
recommended by leading hospice and quality experts \25\ for CMS to
publicly report, or a requirement included in the hospice CoPs. The
indicators required to calculate the single composite are discussed in
the ``Specifications for the HCI Indicators Selected'' section below.
These specifications list all the information required to calculate
each indicator, including the numerator and denominator definitions,
different thresholds for receiving credit toward the overall HCI score,
and explanations for those thresholds. Indicators reflect practices or
outcomes hospices should pursue, thereby awarding points based on the
criterion. The HCI scoring example in Table 16 illustrates how points
are awarded based on meeting the criterion of the indicator. For
example, Gaps in Nursing Visits have a criterion of ``lower than the
90th percentile,'' and supports the hospice CoPs that require a member
of the interdisciplinary team to ensure ongoing assessment of patient
and caregiver needs and plan of care implementation. Other indicators,
such as nurse visits on weekends or near death, have a criterion of
``higher than the 10th percentile,'' identifying hospice care delivery
during the most vulnerable periods during a hospice stay.
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\23\ 2019: Vulnerabilities in Hospice Care (Office of the
Inspector General).
\24\ Report to Congress: Medicare Payment Policy (March 2019)
MEDPAC.
\25\ 2019: Vulnerabilities in Hospice Care (Office of the
Inspector General).
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Each indicator equally affects the single HCI score, reflecting the
equal importance of each aspect of care delivered from admission to
discharge. A hospice is awarded a point for meeting each criterion for
each of the 10 indicators. The sum of the points earned from meeting
the criterion of each indictor results in the hospice's HCI score, with
10 as the highest hospice score. The ten indicators, aggregated into a
single HCI score, convey a broad overview of the quality of hospice
care provision and validates well with CAHPS Willingness to Recommend
and Rating of this Hospice.
The HCI will help to identify whether hospices have aggregate
performance trends that indicate higher or lower quality of care
relative to other hospices. Together with other measures already
publicly reported in the HQRP, HCI scores will help patients and family
caregivers better decide between hospice providers based on the factors
that matter most to them. Additionally, creating a comprehensive
quality measure capturing a variety of related care processes and
outcomes in a single metric will provide consumers and providers an
efficient way to assess the overall quality of hospice care, which can
be used to meaningfully and easily compare hospice providers to make a
better-informed health care decision.
The HCI will complement the existing HIS Comprehensive Measure and
does not replace any existing reported measures. Both the HCI and the
HIS Comprehensive Measure are composite measures in that they act as
single measures that capture multiple areas of hospice care. Because
the indicators comprising the HCI differ in data source from the HIS
Comprehensive Measure, the HCI and the HIS Comprehensive Measure can
together provide a meaningful and efficient way to inform patients and
family caregivers, and support their selection of hospice care
providers. As a claims-based measure, the HCI measure would not impose
any new collection of information requirements. To learn more about the
background of the HCI, please watch this video: https://youtu.be/by68E9E2cZc.
a. Measure Importance
The FY 2019 Hospice Wage Index and Payment Rate Update final rule
(83 FR 38622) introduced the Meaningful Measure Initiative to hospice
providers to identify high priority areas for quality measurement and
improvement. The Meaningful Measure Initiative areas are intended to
increase measure alignment across programs and other public and private
initiatives. Additionally, the initiative points to high priority areas
where there may be informational gaps in available quality measures,
while helping guide our efforts to develop and implement quality
measures to fill those gaps, and develop those concepts towards quality
measures that meet standards for public reporting. The goal of HQRP
quality measure development is to identify measures from a variety of
data sources that provide a window into
[[Page 19732]]
hospice care throughout the dying process, fit well with the hospice
business model, and meet the objectives of the Meaningful Measures
initiative.
To that end, the HCI seeks to add value to the HQRP by filling
informational gaps in aspects of hospice service not addressed by the
current measure set. Consistent with the Meaningful Measure Initiative,
we conducted a number of information gathering activities to identify
informational gaps. Our information gathering activities included
soliciting feedback from hospice stakeholders such as providers and
family caregivers; seeking input from hospice and quality experts
through a Technical Expert Panel (TEP); interviews with hospice quality
experts; considering public comments received in response to previous
solicitations on claims-based hospice quality initiatives; and a review
of quality measurement recommendations offered by the OIG, MedPAC, and
the peer-reviewed literature.
We found that hospices currently underutilize HQRP measures to
inform their quality improvement, mainly because of gaps in relevant
quality information within the HQRP measure set. In particular, the
existing HQRP measure set, calculated using data collected from the HIS
and the CAHPS Hospice survey, does not assess quality of hospice care
during a hospice election (between admission and discharge). Moreover,
the current measure set does not directly address the full range of
hospice services or outcomes. Therefore, we have identified a need for
a new quality measure to address this gap and reflect care delivery
processes during the hospice stay using available data without
increasing data collection burden.
Claims data are the best available data source for measuring care
during the hospice stay and present an opportunity to bridge the
quality measurement gap that currently exists between the HIS and CAHPS
Hospice Survey. Medicare claims are administrative records of health
care services provided and payments which Medicare (and beneficiaries
as applicable) made for those services. Claims are a rich and
comprehensive source about many care processes and aspects of health
care utilization. As such, they are a valuable source of information
that can be used to measure the quality of care provided to
beneficiaries for several reasons:
Claims data are readily-available and reduce provider
burden for implementation, as opposed to data collection through
patient assessments or surveys, which require additional effort from
clinicians, patients, and family caregivers before they can be
submitted and used by CMS.
Claims data are collected based on care delivered,
providing a more direct reflection of care delivery decisions and
actions than patient assessments or surveys.
Claims data are considered a reliable source of
standardized data about the services provided, because providers must
comply with Medicare payment and claims processing policy.
Currently, CMS does publicly report several pieces of information
derived from hospice claims data in the HQRP on Care Compare, including
(i) the levels of care the hospice provided, (ii) the primary diagnoses
the hospice served, (iii) the sites of service hospices provided care,
and (iv) the hospice's daily census.
In the FY2018 Hospice Wage Index & Payment Rate proposed rule (82
FR 20750), we solicited public comment on two high-priority claims-
based measure concepts being considered at the time, one which looked
at transitions from hospice and another which examined access to higher
levels of hospice care. In response to this solicitation, CMS received
public comments highlighting the potential limitations of a single
concept claims-based measure. In particular, a single-concept claims-
based measure may not adequately account for all relevant circumstances
that might influence a hospice's performance. While external
circumstances could justify a hospice's poor performance on a single
claims-based indicator, it would be unlikely for external circumstances
to impact multiple claims-based indicators considered simultaneously.
Therefore, the results of a multi-indicator claims-based index, such as
HCI, is more likely to differentiate hospices than a single claims-
based indicator. Taking this public feedback into consideration, we
designed the HCI and developed the specifications based on simulated
reporting periods.
b. Specifications for the HCI Indicators Selected
The specifications for the ten indicators required to calculate the
single HCI score are described in this section. These component
indicators reflect various elements and outcomes of care provided
between admission and discharge. The HCI uses information from all ten
indicators to collectively represent a hospice's ability to address
patients' needs, best practices hospices should observe, and/or care
outcomes that matter to consumers. Each indicator is a key component of
the HCI measure that we are proposing, and all ten are necessary to
derive the HCI score. We use analytics, based on a variety of data
files, to specify the indicators and measure. These data files include:
Medicare fee-for-service (FFS) hospice claims with through
dates on and between October 1, 2016 and September 30, 2019 to
determine information such as hospice days by level of care, provision
of visits, live discharges, hospice payments, and dates of hospice
election.
Medicare fee-for-service inpatient claims with through
dates on and between January 1, 2016 and December 31, 2019 to determine
dates of hospitalization.
Medicare beneficiary summary file to determine dates of
death.
Provider of Services (POS) File to examine trends in the
scores of the HCI and its indicators, including by decade by which the
hospice was certified for Medicare, ownership status, facility type,
census regions, and urban/rural status.
CAHPS Hospice Survey to examine alignment between the
survey outcomes and the HCI.
We acquired all claims data from the Chronic Conditions Warehouse
(CCW) Virtual Research Data Center (VRDC). We obtained the hospice
claims and the Medicare beneficiary summary file in May 2020, and the
inpatient data in August 2020. We obtained the POS file data via:
https://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Provider-of-Services. We obtained the Hospice-
aggregate CAHPS Hospice Survey outcome data via: https://data.cms.gov/provider-data. We performed analyses using Stata/MP Version 16.1.
Table 17 indicates the number of hospice days, hospice claims,
beneficiaries enrolled in hospices and hospices with at least one claim
represented in each year of our analysis. Analysis for each year was
based on the FY calendar. For example, FY 2019 covers claims with dates
of services on or between October 1, 2018 and September 30, 2019. For
these analyses, we exclude claims from hospices with 19 or fewer
discharges \26\ within a FY. The table reports the sample size before
and after exclusion.\27\
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\26\ We count discharges as any claim with a discharge status
code other than ``30'' (which is defined as ``Still Patient'')
\27\ Another exclusion was made prior to reporting the numbers
in Table B.1. We exclude all claims for a beneficiary if a
beneficiary ever had two overlapping hospice days on separate
claims. For FY 2019 this removes 5,212,319 hospice days that come
from 218,420 claims and 33,009 beneficiaries.
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[[Page 19733]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.023
The rest of this section presents the component indicators and
their specifications. Although we describe each component indicator
separately, the HCI is a composite that can only be calculated using
all 10 indicators combined. We believe that, composed of this set of
ten indicators, the HCI will strengthen the HQRP by comprehensively,
reflecting hospices' performance across all ten indicators.
(1). Indicator One: Continuous Home Care (CHC) or General Inpatient
(GIP) Provided
Medicare Hospice Conditions of Participation (CoPs) require
hospices to be able to provide both CHC and GIP levels of care, if
needed to manage more intense symptoms.28 29 However, a 2013
OIG report \30\ found that 953 hospice programs did not provide any GIP
level of care services, and it was unclear if dying patients at such
hospices were receiving appropriate pain control or symptoms management
(a similar concern exists for hospice services at the CHC level). To
consider the provision of adequate services needed to manage patients'
symptoms, the HCI measure includes an indicator for whether hospice
programs provided any CHC or GIP service days. This indicator
identifies hospices that provided at least one day of hospice care
under the CHC or the GIP levels of care during the period examined. The
provision of CHC and GIP is identified on hospice claims by the
presence of revenue center codes 0652 (CHC) and 0656 (GIP).
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\28\ See Special coverage requirements, Title 42, Chapter IV,
Subchapter B, Part 418, Sec. 418.204. https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_1204.
\29\ See Payment procedures for hospice care, Title 42, Chapter
IV, Subchapter B, Part 418, Sec. 418.302. https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_1302.
\30\ Office of Inspector General. (2013). Medicare Hospice: Use
of General lnpatient Care. https://oig.hhs.gov/oei/reports/oei-02-10-00490.pdf.
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The specifications for Indicator One, CHC or GIP services provided,
are as follows:
Numerator: The total number of CHC or GIP services days
provided by the hospice within a reporting period.
Denominator: The total number of hospice service days
provided by the hospice at any level of care within a reporting period.
Index Earned Point Criterion: Hospices earn a point
towards the HCI if they provided at least one CHC or GIP service day
within a reporting period.
(2). Indicator Two: Gaps in Nursing Visits
The Medicare Hospice CoPs require a member of the interdisciplinary
team to ensure ongoing assessment of patient and caregiver needs and
plan of care implementation.\31\ The OIG has found instances of
infrequent visits by nurses to hospice patients.\32\ To assess
patients' receipt of adequate oversight, one HCI indicator examines
hospices that have a high rate of patients who are not seen at least
once a week by nursing staff.
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\31\ See Sec. 418.56 (https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_156) and Sec. 418.76
(https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_176).
\32\ Office of Inspector General. (2019). Hospice Deficiencies
Pose Risks to Medicare Beneficiaries. https://oig.hhs.gov/oei/reports/oei-02-17-00020.pdf?utm_source=summary-page&utm_medium=web&utm_campaign=OEI-02-17-00020-PDF.
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This indicator identifies whether a hospice is below the 90th
percentile in terms of how often hospice stays of at least 30 days
contain at least one gap of eight or more days without a nursing visit.
Days of hospice service are identified based on the presence of revenue
center codes 0651 (routine home care (RHC)), 0652 (CHC), 0655
(inpatient respite care (IRC)), and 0656 (GIP) on hospice claims. We
identify the dates billed for RHC, IRC, and GIP by examining the
corresponding revenue center date (which identifies the first day in
the sequence of days by level of care) and the revenue center units
(which identify the number of days (including the first day) in the
sequence of days by level of care). We identify the dates billed for
CHC by examining the revenue center date.\33\ We define a hospice stay
by a sequence of consecutive days for a particular beneficiary that are
billed under the hospice benefit. A gap of at least 1 day without
hospice ends the sequence. For this indicator, we identified hospice
stays that included 30 or more consecutive days of hospice. Once we
identified those hospice stays, we examined the timing of the provision
of nursing visits within those stays. We identified nursing visits if
we observed any of the following criteria:
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\33\ Hospices bill each day of CHC on a separate line item on
the hospice claim.
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The presence of revenue center code 055x (Skilled Nursing)
on the hospice claim. The date of the visit is recorded in the
corresponding revenue center date.
The presence of revenue code 0652 (CHC) on the hospice
claim. Days billed as CHC require more than half the hours provided be
nursing hours.
The presence of revenue code 0656 (GIP) on the hospice
claim. We assume that days billed as GIP will include nursing visits.
We make that assumption instead of looking at the visits directly
because Medicare does not require hospices to record all visits on the
claim for the GIP level of care.
Based on the above information, if within a hospice stay, we find
eight or more consecutive days where no nursing visits are provided, no
CHC is provided, and no GIP is provided, then we identify the hospice
stay as having a gap in nursing visits greater than 7 days. This
indicator helps the HCI to capture patients' receipt of adequate
oversight through nurse visits and direct patient care, which is an
important aspect of hospice care. For each hospice, we divide the
number of stays with at least one gap of eight or more days without a
nursing visit (for stays of 30 or more days) by the number of stays of
30 or more days. We only consider the days within the period being
examined.
The specifications for Indicator Two, Gaps in Nursing Visits, are
as follows:
[[Page 19734]]
Numerator: The number of elections with the hospice where
the patient experienced at least one gap between nursing visits
exceeding 7 days, excluding hospice elections where the patient elected
hospice for less than 30 days within a reporting period.
Denominator: The total number of elections with the
hospice, excluding hospice elections where the patient elected hospice
for less than 30 days within a reporting period.
Index Earned Point Criterion: Hospices earn a point
towards the HCI if their individual hospice score for gaps in nursing
visits greater than 7 days falls below the 90th percentile ranking
among hospices nationally.
(3). Indicator Three: Early Live Discharges
Prior work has identified various concerning patterns of live
discharge from hospice. High rates of live discharge suggest concerns
in hospices' care processes, their advance care planning to prevent
hospitalizations, or their discharge processes.\34\ As MedPAC
noted,\35\ ``Hospice providers are expected to have some rate of live
discharges because some patients change their mind about using the
hospice benefit and dis-enroll from hospice or their condition improves
and they no longer meet the hospice eligibility criteria. However,
providers with substantially higher percent of live discharge than
their peers could signal a potential concern with quality of care or
program integrity. An unusually high rate of live discharges could
indicate that a hospice provider is not meeting the needs of patients
and families or is admitting patients who do not meet the eligibility
criteria.''
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\34\ Teno J.M., Bowman, J., Plotzke, M., Gozalo, P.L.,
Christian, T., Miller, S.C., Williams, C., & Mor, V. (2015).
Characteristics of hospice programs with problematic live
discharges. Journal of Pain and Symptom Management, 50, 548-552.
doi: 10.1016/j.jpainsymman.2015.05.001.
\35\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
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Our live discharge indicators included in the HCI, like MedPAC's,
comprise discharges for all reasons. They include instances where the
patient was no longer found terminally ill and revocations due to the
patient's choice. MedPAC explains their rationale for including all
discharge as follows:\36\
---------------------------------------------------------------------------
\36\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
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``Some stakeholders argue that live discharges initiated by the
beneficiary--such as when the beneficiary revokes his or her hospice
enrollment--should not be included in a live-discharge measure because,
some stakeholders assert, these discharges reflect beneficiary
preferences and are not in the hospice's control. Because beneficiaries
may choose to revoke hospice for a variety of reasons, which in some
cases are related to the hospice provider's business practices or
quality of care, we include revocations in our analysis.''
This indicator identifies whether a hospice is below the 90th
percentile in terms of the percentage of live discharges that occur
within 7 days of hospice admission during the fiscal year examined.
Live discharges occur when the patient discharge status code on a
hospice claim does not equal a code from the following list: ``30'',
``40'', ``41'', ``42'', ``50'', ``51''. We measure whether a live
discharge occurs during the first 7 days of hospice by looking at a
patient's lifetime length of stay in hospice.\37\ For each hospice, we
divide the number of live discharges in the first 7 days of hospice by
the number of live discharges. Live discharges are assigned to a
particular reporting period based on the date of the live discharge
(which corresponds to the through date on the claim indicating the live
discharge).
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\37\ That is, we are measuring the first seven days of hospice
over a patient's lifetime and potentially across multiple hospice
elections and fiscal years.
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The specifications for Indicator Three, Early Live Discharges, are
as follows:
Numerator: The total number of live discharges from the
hospice occurring within the first 7 days of hospice within a reporting
period.
Denominator: The total number of all live discharge from
the hospice within a reporting period.
Index Earned Point Criterion: Hospices earn a point
towards the HCI if their individual percentage of live discharges on or
before the seventh day of hospice falls below the 90th percentile
ranking among hospices nationally.
(4). Indicator Four: Late Live Discharges
The rate of live discharge that occurred 180 days or more after
hospice enrollment identifies another potentially concerning pattern of
live discharge from hospice. Both indicator three and indicator four of
the HCI recognize concerning patterns of live discharge impacting
patient experience and quality of care. MedPAC, in descriptive analyses
of hospices exceeding the Medicare annual payment cap, noted that ``if
some hospices have rates of discharging patients alive that are
substantially higher than most other hospices it raises concerns that
some hospices may be pursuing business models that seek out patients
likely to have long stays who may not meet the hospice eligibility
criteria''.\38\ Because of quality implications for hospices who pursue
such business models, the live discharge after long hospice enrollments
was included in the index.
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\38\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
---------------------------------------------------------------------------
This indicator identifies whether a hospice is below the 90th
percentile in terms of the percentage of live discharges that occur on
or after the 180th day of hospice. Live discharges occur when the
patient discharge status code does not equal a value from the following
list: ``30'', ``40'', ``41'', ``42'', ``50'', ``51''. We measure
whether a live discharge occurs on or after the 180th day of hospice by
looking at a patient's lifetime length of stay in hospice. For each
hospice, we divide the number of live discharges that occur on or after
the 180th day of hospice by the number of live discharges. Live
discharges are assigned to a particular reporting period based on the
date of the live discharge (which corresponds to the through date on
the claim).
The specifications for Indicator Four, Late Live Discharges, are as
follows:
Numerator: The total number of live discharges from the
hospice occurring on or after 180 days of enrollment in hospice within
a reporting period.
Denominator: The total number of all live discharge from
the hospice within a reporting period.
Index Earned Point Criterion: Hospices earn a point
towards the HCI if their individual hospice score for live discharges
on or after the 180th day of hospice falls below the 90th percentile
ranking among hospices nationally.
(5). Indicator Five: Burdensome Transitions (Type 1)--Live Discharges
From Hospice Followed by Hospitalization and Subsequent Hospice
Readmission
The Type 1 burdensome transitions reflects hospice live discharge
with a hospital admission within 2 days of hospice discharge, and then
hospice readmission within 2 days of hospital discharge. This pattern
of transitions may lead to fragmented care and may be associated with
concerning care processes. For example, Type 1 burdensome transitions
may arise from a deficiency in advance care planning to prevent
hospitalizations or a discharge process that does not appropriately
identify a hospice patient whose conditions are stabilized prior to
discharge.\39\
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\39\ For example, see: Teno J.M., Bowman, J., Plotzke, M.,
Gozalo, P.L., Christian, T., Miller, S.C., Williams, C., & Mor, V.
(2015). Characteristics of hospice programs with problematic live
discharges. Journal of Pain and Symptom Management, 50, 548-552.
doi: 10.1016/j.jpainsymman.2015.05.001.
---------------------------------------------------------------------------
[[Page 19735]]
This indicator identifies whether a hospice is below the 90th
percentile in terms of the percentage of live discharges that are
followed by a hospitalization (within 2 days of hospice discharge) and
then followed by a hospice readmission (within 2 days of
hospitalization) during the FY examined. Live discharges occur when the
patient discharge status code does not equal a value from the following
list: ``30'', ``40'', ``41'', ``42'', ``50'', ``51''. Hospitalizations
are found by looking at all fee-for-service Medicare inpatient claims.
Overlapping inpatient claims were combined to determine the full length
of a hospitalization (looking at the earliest from date and latest
through date from a series of overlapping inpatient claims for a
beneficiary). In order to be counted, the ``from'' date of the
hospitalization had to occur no more than 2 days after the date of
hospice live discharge.\40\ From there, we found all beneficiaries that
ended their hospitalization and were readmitted back to hospice no more
than 2 days after the last date of the hospitalization. To calculate
the percentage, for each hospice we divided the number of live
discharges that are followed by a hospitalization (within 2 days of
hospice discharge) and then followed by a hospice readmission (within 2
days of hospitalization) in a given reporting period by the number of
live discharges in that same period.
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\40\ For example, if the hospice discharge occurred on a Sunday,
the hospitalization had to occur on Sunday, Monday, or Tuesday to be
counted.
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The specifications for Indicator Five, Burdensome Transitions Type
1, are as follows:
Numerator: The total number of live discharges from the
hospice followed by hospital admission within 2 days, then hospice
readmission within 2 days of hospital discharge within a reporting
period.
Denominator: The total number of all live discharge from
the hospice within a reporting period.
Index Earned Point Criterion: Hospices earn a point
towards the HCI if their individual hospice score for Type 1 burdensome
transitions falls below the 90th percentile ranking among hospices
nationally.
(6). Indicator Six: Burdensome Transitions (Type 2)--Live Discharges
From Hospice Followed by Hospitalization With the Patient Dying in the
Hospital
Death in a hospital following live discharge in another concerning
pattern in hospice use. Thus, we believe that indicators five and
indicator six of the HCI are necessary to differentiate concerning
behaviors affecting patient care. This indicator reflects hospice live
discharge followed by hospitalization within 2 days with the patient
dying in the hospital, referred to as Type 2 burdensome transitions.
This pattern of transitions may be associated with a discharge process
that does not appropriately assess the stability of a hospice patient's
conditions prior to live discharge.\41\
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\41\ For example, see: Teno J.M., Bowman, J., Plotzke, M.,
Gozalo, P.L., Christian, T., Miller, S.C., Williams, C., & Mor, V.
(2015). Characteristics of hospice programs with problematic live
discharges. Journal of Pain and Symptom Management, 50, 548-552.
doi: 10.1016/j.jpainsymman.2015.05.001.
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This indicator identifies whether a hospice is below the 90th
percentile in terms of the percentage of live discharges that are
followed by a hospitalization (within two days of hospice discharge)
and then the patient dies in the hospital. Live discharges occur when
the patient discharge status code does not equal a value from the
following list: ``30'', ``40'', ``41'', ``42'', ``50'', ``51''.
Hospitalizations are found by looking at all inpatient claims.
Overlapping inpatient claims were combined to determine a full length
of a hospitalization (looking at the earliest from date and latest
through date from a series of overlapping inpatient claims). To be
counted, the ``from'' date of the hospitalization had to occur no more
than 2 days after the date of hospice live discharge. From there, we
identified all beneficiaries whose date of death is listed as occurring
during the dates of the hospitalization. To calculate the percentage,
for each hospice we divided the number of live discharges that are
followed by a hospitalization (within 2 days of hospice discharge) and
then the patient dies in the hospital in a given FY by the number of
live discharges in that same reporting period.
The specifications for Indicator Six, Burdensome Transitions Type
2, are as follows:
Numerator: The total number of live discharges from the
hospice followed by a hospitalization within 2 days of live discharge
with death in the hospital within a reporting year.
Denominator: The total number of all live discharge from
the hospice within a reporting year.
Index Earned Point Criterion: Hospices earn a point
towards the HCI if their individual hospice score for Type 2 burdensome
transitions falls below the 90th percentile ranking among hospices
nationally.
(7). Indicator Seven: Per-Beneficiary Medicare Spending
Estimates of per-beneficiary spending are endorsed by NQF (#2158)
\42\ and publicly reported by CMS for other care settings. Because the
Medicare hospice benefit pays a per diem rate, an important determinant
of per-beneficiary spending is the length of election. MedPAC reported
that nearly half of Medicare hospice expenditures are for patients that
have had at least 180 or more days on hospice, and expressed a concern
that some programs do not appropriately discharge patients whose
medical condition makes them no longer eligible for hospice services,
or, that that hospices selectively enroll patients with non-cancer
diagnoses and longer predicted lengths of stay in hospice.\43\ The
other determinant of per-beneficiary spending is the level of care at
which services are billed. In a 2016 report, the OIG has expressed
concern at the potentially inappropriate billing of GIP care.\44\ For
these reasons the HCI includes one indicator for per-beneficiary
spending; lower rates of per beneficiary spending may identify hospices
that provide efficient care at a lower cost to Medicare.
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\42\ National Quality Forum. (2013). #2158 Payment-Standardized
Medicare Spending Per Beneficiary (MSPB). https://www.qualityforum.org/Projects/c-d/Cost_and_Resource_Project/2158.aspx.
\43\ MedPAC. (2020). Chapter 12: Hospice Services. http://medpac.gov/docs/default-source/reports/mar20_medpac_ch12_sec.pdf.
\44\ Office of Inspector General. (2016). Hospices
Inappropriately Billed Medicare Over $250 Million for General
Inpatient Care. https://oig.hhs.gov/oei/reports/oei-02-10-00491.pdf.
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This indicator identifies whether a hospice is below the 90th
percentile in terms of the average Medicare hospice payments per
beneficiary. Hospice payments per beneficiary are determined by summing
together all payments on hospice claims for a particular reporting year
for a particular hospice. The number of beneficiaries a hospice serves
in a particular year is determined by counting the number of unique
beneficiaries on all hospice claims in the same period for a particular
hospice. Medicare spending per beneficiary is then calculated by
dividing the total payments by the total number of unique
beneficiaries.
The specifications for Indicator Seven, Per-Beneficiary Medicare
Spending, are as follows:
[[Page 19736]]
Numerator: Total Medicare hospice payments received by a
hospice within a reporting period.
Denominator: Total number of beneficiaries electing
hospice with the hospice within a reporting period.
Index Earned Point Criterion: Hospices earn a point
towards the HCI if their average Medicare spending per beneficiary
falls below the 90th percentile ranking among hospices nationally.
(8). Indicator Eight: Nurse Care Minutes per Routine Home Care (RHC)
Day
Medicare Hospice CoPs require a member of the interdisciplinary
team to ensure ongoing assessment of patient and caregiver needs.\45\
Such assessment is necessary to ensure the successful preparation,
implementation, and refinements for the plan of care. Hospices must
also ensure that patients and caregivers receive education and training
as appropriate to their responsibilities for the care and services
identified in the plan of care. To assess adequate oversight, the HCI
includes this indicator assessing the average number of skilled nursing
minutes per day during RHC days to differentiate hospices that are
providing assessment throughout the hospice stay.
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\45\ See Condition of participation: Interdisciplinary group,
care planning, and coordination of services, Title 42, Chapter IV,
Subchapter B, Part 418, Sec. 418.56 (https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_156) and Condition
of participation: Hospice aide and homemaker services, Title 42,
Chapter IV, Subchapter B, Part 418, Sec. 418.76 (https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_176).
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This indicator identifies whether a hospice is above the 10th
percentile in terms of the average number of nursing minutes provided
on RHC days during the reporting period examined. We identify RHC days
by the presence of revenue code 0651 on the hospice claim. We identify
the dates of RHC service by the corresponding revenue center date
(which identifies the first day of RHC) and the revenue center units
(which identifies the number of days of RHC (including the first day of
RHC)). We identify nursing visits by the presence of revenue code 055x
(Skilled Nursing) on the claim. We count skilled nursing visits where
the corresponding revenue center date overlaps with one of the days of
RHC previously identified. We then count the minutes of skilled nursing
visits by taking the corresponding revenue center units (that is, one
unit is 15 minutes) and multiplying by 15. For each hospice, we sum
together all skilled nursing minutes provided on RHC days and divide by
the sum of RHC days.
The specifications for Indicator Eight, Nurse Care Minutes per RHC
Day, are as follows:
Numerator: Total skilled nursing minutes provided by a
hospice on all RHC service days within a reporting period.
Denominator: The total number of RHC days provided by a
hospice within a reporting period.
Index Earned Point Criterion: Hospices earn a point
towards the HCI if their individual hospice score for Nursing Minutes
per RHC day falls above the 10th percentile ranking among hospices
nationally.
(9). Indicator Nine: Skilled Nursing Minutes on Weekends
Our regulations at Sec. 418.100(c)(2) require that ``[n]ursing
services, physician services, and drugs and biologicals . . . be made
routinely available on a 24-hour basis seven days a week''.\46\ Ongoing
assessment of patient and caregiver needs and plan of care
implementation are necessary for adequate hospice care oversight. Fewer
observed hospice services on weekends (relative to that provided on
weekdays) is not itself an indication of a lack of access. In fact, on
weekends, patients' caregivers are more likely to be around and could
prefer privacy from hospice staff. However, patterns of variation
across providers could signal less service provider availability and
access for patients on weekends. Thus, the HCI includes this indicator
to further differentiate whether care is available to patients on
weekends. To assess hospice service availability, this indicator
includes minutes of care provided by skilled nurses on weekend RHC
days.
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\46\ See Sec. 418.100 (https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=42%3A3.0.1.1.5#se42.3.418_1100).
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This indicator identifies whether a hospice is at or above the 10th
percentile in terms of the percentage of skilled nursing minutes
performed on weekends compared to all days during the reporting period
examined. We identify RHC days by the presence of revenue code 0651 on
the hospice claim. We identify the dates of RHC service by the
corresponding revenue center date (which identifies the first day of
RHC) and the revenue center units (which identifies the number of days
of RHC (including the first day of RHC)). We identify nursing visits by
the presence of revenue code 055x (Skilled Nursing) on the claim. We
count skilled nursing visits where the corresponding revenue center
date overlaps with one of the days of RHC previously identified. We
then count the minutes of skilled nursing visits by taking the
corresponding revenue center units and multiplying by 15. For each
hospice, we sum together all skilled nursing minutes provided on RHC
days that occur on a Saturday or Sunday and divide by the sum of all
skilled nursing minutes provided on all RHC days.
The specifications for Indicator Nine, Skilled Nursing Minutes on
Weekends, are as follows:
Numerator: Total sum of minutes provided by the hospice
during skilled nursing visits during RHC services days occurring on
Saturdays or Sunday within a reporting period.
Denominator: Total skilled nursing minutes provided by the
hospice during RHC service days within a reporting period.
Index Earned Point Criterion: Hospices earn a point
towards the HCI if their individual hospice score for percentage of
skilled nursing minutes provided during the weekend is above the 10th
percentile ranking among hospices nationally.
(10). Indicator Ten: Visits Near Death
The end of life is typically the period in the terminal illness
trajectory with the highest symptom burden. Particularly during the
last few days before death, patients (and caregivers) experience many
physical and emotional symptoms, necessitating close care and attention
from the integrated hospice team and drawing increasingly on hospice
team resources.47 48 49 Physical symptoms of actively dying
can often be identified within three days of death in some
patients.\50\
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\47\ de la Cruz, M., et al. (2015). Delirium, agitation, and
symptom distress within the final seven days of life among cancer
patients receiving hospice care. Palliative & Supportive Care,
13(2): 211-216. doi: 10.1017/S1478951513001144.
\48\ Dellon, E.P., et al. (2010). Family caregiver perspectives
on symptoms and treatments for patients dying from complications of
cystic fibrosis. Journal of Pain & Symptom Management, 40(6): 829-
837. doi: 10.1016/j.jpainsymman.2010.03.024.
\49\ Kehl, K.A., et al. (2013). A systematic review of the
prevalence of signs of impending death and symptoms in the last 2
weeks of life. American Journal of Hospice & Palliative Care, 30(6):
601-616. doi: 10.1177/1049909112468222.
\50\ Hui D et al. (2014). Clinical Signs of Impending Death in
Cancer Patients. The Oncologist. 19(6):681-687. doi:10.1634/
theoncologist.2013-0457.
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This indicator identifies whether a hospice is at or above the 10th
percentile in terms of the percentage of beneficiaries with a nurse
and/or medical social services visit in the last 3 days of life. For
this indicator, we first
[[Page 19737]]
determine if a beneficiary was in hospice for at least 1 day during
their last 3 days of life by comparing days of hospice enrollment from
hospice claims to their date of death. We identify nursing visits and
medical social service visits by the presence of revenue code 055x
(Skilled Nursing) and 056x (Medical Social Services) on the claim. We
identify the dates of those visits by the revenue center date for those
revenue codes.
Additionally, we assume that days billed as GIP (revenue code 0656)
will include nursing visits. We make that assumption instead of looking
at the visits directly because Medicare does not require hospices to
record all visits on the claim for the GIP level of care. For each
hospice, we divide the number of beneficiaries with a nursing or
medical social service visits on a hospice claim during the last 3 days
of life by the number of beneficiaries with at least 1 day of hospice
during the last 3 days of life.
The specifications for Indicator Ten, Visits Near Death, are as
follows:
Numerator: The number of decedent beneficiaries receiving
a visit by a skilled nurse or social worker staff for the hospice in
the last 3 days of the beneficiary's life within a reporting period.
Denominator: The number of decedent beneficiaries served
by the hospice within a reporting period.
Index Earned Point Criterion: Hospices earn a point
towards the HCI if their individual hospice score for percentage of
decedents receiving a visit by a skilled nurse or social worked in the
last 3 days of life falls above the 10th percentile ranking among
hospices nationally.
(11). Hospice Care Index Scoring Example
As discussed during the NQF's January 2021 MAP meeting, the HCI
summarizes information from ten indicators with each indicator
representing key components of the hospice care recognizing care
delivery and processes. Hospices receive a single HCI score, which
reflects the information from all ten indicators. Specifically, a
hospice's HCI score is based on its collective performance on the ten
performance indicators detailed above, all of which must be included to
calculate the score and meaningfully distinguish between hospices'
relative performance. The HCI's component indicators are assigned a
criterion determined by statistical analysis of an individual hospice's
indicator score relative to national hospice performance. Table 18
illustrates how a hypothetical hospice's score is determined across all
ten indicators, and how the ten indicators' scores determine the
overall HCI score.
BILLING CODE 4120-01-P
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[GRAPHIC] [TIFF OMITTED] TP14AP21.024
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BILLING CODE 4120-01-C
c. Measure Reportability, Variability, and Validity
As part of developing the HCI, we conducted reportability,
variability, and validity testing using claims data from FY 2019.
Reportability analyses found a high proportion of hospices (over 85
percent) that would yield reportable measure scores over 1 year (for
more on reportability analysis, see section (2) Update on Use of Q4
2019 Data and Data Freeze for Refreshes in 2021.). Variability analyses
confirmed that HCI demonstrates sufficient ability to differentiate
hospices. Hospices' scores on the HCI can range from zero to ten.
During measure testing, we observed that hospices achieved scores
between three and ten. In testing, 37.1 percent of hospices scored ten
out of ten, 30.4 percent scored nine out of ten, 17.9 percent scored
eight out of ten, 9.6 percent scored seven out of ten, and 5.0 percent
scored six or lower, as shown in Figure 6.
[GRAPHIC] [TIFF OMITTED] TP14AP21.025
Validity analyses showed that hospices' HCI scores align with
family caregivers' perceptions of hospice quality, as measured by CAHPS
Hospice survey responses (NQF endorsed quality measure #2651). Hospices
with higher HCI scores generally achieve better caregiver ratings as
measured by CAHPS Hospice scores, and hospices with lower HCI scores
generally achieve poorer CAHPS Hospice scores. As measured by Pearson's
correlation coefficients, the correlation between the CAHPS hospice
overall rating and the HCI is +0.0675, and the correlation between the
CAHPS hospice recommendation outcome and the HCI score is +0.0916. As
such, HCI scores are consistent with CAHPS Hospice caregiver ratings,
supporting the index as a valid measurement of hospice care.
We also conducted a stability analysis by comparing index scores
calculated for the same hospice using claims from Federal FY 2017 and
2019. The analysis found that 82.8 percent of providers' scores changed
by, at most, one point over the 2 years. These results serve as
evidence of the measure's reliability by indicating that a hospice's
HCI scores would not normally fluctuate a great deal from one year to
the next.
d. Stakeholder Support
A TEP convened by our measure development contractor, in April
2020, provided input on this measure concept. Additionally, during the
summer of 2020, CMS convened five listening sessions with national
hospice provider organizations to discuss the HCI concept with the
goals of engaging stakeholders and receiving feedback early in the
measure's development. In October 2020, our contractor, Abt Associates,
convened a workgroup of family caregivers whose family members have
received hospice care to provide input on this measure concept from the
family and caregiver perspective. Finally, the NQF Measures Application
Partnership (MAP) met on January 11, 2021 and provided input to CMS.
The MAP conditionally supports the HCI for rulemaking contingent on NQF
endorsement. The ``2020-2021 MAP 2020 Final Recommendations'' can be
found at: http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94893.
Stakeholders were generally supportive of a quality measure based
on multiple indicators using claims data for public reporting. Several
hospice providers expressed support for the measure's ability to
demonstrate greater variation in hospice performance than the component
indicators taken individually. Hospice caregivers also welcomed the
addition of new quality measures to HQRP to better differentiate
between hospices. In particular, family caregivers stated that there
might be a need for several HCI indicators, such as nursing
availability on weekends and average Medicare per-beneficiary spending,
to be included on Care Compare as additional information.
Some stakeholders raised concerns that claims data may not
adequately express the quality of care provided, and may be better
suited as an indicator for program integrity or compliance issues.
Hospice providers suggested that claims may lack sufficient information
to adequately reflect individual patient needs or the full array of
hospice
[[Page 19740]]
practices. In particular, claims do not fully capture patients'
clinical conditions, patient and caregiver preferences, or hospice
activities such as telehealth, chaplain visits, and specialized
services such as massage or music therapy. After much consideration of
the input received, we believe the benefits of proposing adoption of
the HCI outweigh its limitations. The HCI would not be intended to
account for all potentially valuable aspects of hospice care, nor would
it be expected to entirely close the information gaps presently found
in the HQRP. Rather, the HCI would serve as a useful measure to add
value to the HQRP by providing more information to patients and family
caregivers and better empowering them to make informed health care
decisions. We view the HCI as an opportunity to add value to the HQRP,
augmenting the current measure set with an index of indicators compiled
from currently available claims data. This will provide new and useful
information to patients and family caregivers without further burden to
them, or to providers.
Stakeholders also suggested several valuable exploratory analyses,
improvements for the indicators presented, and ideas for eventual
public display for CMS to consider. We further refined the HCI based on
this feedback, focusing on those indicators with the strongest
consistency with CAHPS Hospice scores and/or which quality experts have
identified as salient issues for measurement and observation. We also
revised and refined how the HCI will be publicly displayed on Care
Compare in response to family caregiver input.
e. Form, Manner and Timing of Data Collection and Submission
The data source for this HCI measure will be Medicare claims data
that are already collected and submitted to CMS. We propose to begin
reporting this measure using existing data items no earlier than May
2022. For more details, see section (3). Proposal to Publicly Report
the Hospice Care Index and Hospice Visits in the Last Days of Life
Claims-based Measures.
In addition, to help hospices understand the HCI and their
hospice's performance, we will revise the confidential QM report to
include claims-based measure scores, including agency and national
rates through the Certification and Survey Provider Enhanced Reports
(CASPER) or replacement system. The QM report will also include results
of the individual indicators used to calculate the single HCI score,
and provide details on the indicators and HCI overall score to support
hospices in interpreting the information. The HCI indicators will be
available by visiting the Provider Data Catalog at https://data.cms.gov/provider-data/topics/hospice-care.
We are soliciting public comment on the proposal to add the
composite HCI measure to the HQRP starting in FY 2022. We are also
soliciting comments on the proposal to add the HCI to the program for
public reporting beginning no earlier than May 2022.
4. Update on the Hospice Visits in the Last Days of Life (HVLDL) and
Hospice Item Set V3.00
On August 13, 2020, we sought public comment in an information
collection request to remove Section O ``Service Utilization''
(hereafter referred to as Section O) of the HIS discharge assessment.
Removal of Section O is the sole change from HIS V2.01 and in effect
eliminate the HVWDII quality measure pair. In Paperwork Reduction Act
package (PRA), CMS-10390 (OMB control number: 0938-1153), we also
proposed to replace the HVWDII measure pair with the HVLDL. This means
that we will no longer report HVWDII with patient discharges and will
start publicly reporting HVLDL no earlier than May 2022. The Office of
Management and Budget (OMB) approved the collection of information to
remove Section O of the HIS expiring on February 29, 2024, (OMB Control
Number: 0938-1153, CMS-10390). We direct the public to review the PRA
at https://www.cms.gov/regulations-and-guidancelegislationpaperworkreductionactof1995pra-listing/cms-10390 and
HVWDII report at https://www.cms.gov/files/document/hqrphospice-visits-when-death-imminent-testing-re-specification-reportoctober-2020.pdf. As
a claims-based measure, the HVLDL measure would not impose any new
collection of information requirements.
The HVLDL measure, as a replacement, will continue to fill an
important area in hospice care previously filled by the HVWDII measure
pair. We discussed the analysis with a TEP convened by our measure
development contractor in November 2019 and with the MAP, hosted by the
NQF in December 2019 \51\ for inclusion in the HQRP. During these
meetings, the discussions reflecting on the analysis generally
supported the replacement of HVWDII with a claims-based HVLDL measure.
The November 2019 TEP report can be found in the downloads section at
Hospice QRP Provider Engagement Opportunities and final recommendations
and presentation of the HVLDL measure before NQF's MAP can be found at
Quality Forum--Post-Acute Care, https://www.qualityforum.org/Publications/2020/02/MAP_2020_Considerations_for_Implementing_Measures_Final_Report_-_PAC_LTC.aspx.
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\51\ National Quality Forum. (2020). MAP 2020 Considerations for
Implementing Measures Final Report--PAC LTC. http://www.qualityforum.org/Publications/2020/02/MAP_2020_Considerations_for_Implementing_Measures_Final_Report_-_PAC_LTC.aspx.
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OMB approved the proposal to replace the HVWDII measure with the
HVLDL measure and remove Section O from the discharge assessment on
February 16, 2021. The HIS V3.00 became effective on February 16, 2021
and expires on February 29, 2024; OMB control number 0938-1153.
5. Proposal To Revise Sec. 418.312(b) Submission of Hospice Quality
Reporting Program Data
To address the inclusion of administrative data, such as Medicare
claims used for hospice claims-based measures like the HVLDL and HCI in
the HQRP and correct technical errors identified in the FY 2016 and
2019 Hospice Wage Index and Payment Rate Update final rules, we propose
to revise the regulation at Sec. 418.312(b) by adding paragraphs
(b)(1) through (3). As proposed, paragraph (b)(1) would now include the
existing language on the standardized set of admission and discharge
items. Paragraph (b)(2) would require collection of Administrative
Data, such as Medicare claims data, used for hospice quality measures
to capture services throughout the hospice stay. And these data
automatically meet the HQRP requirements for Sec. 418.306(b)(2).
Paragraph (b)(3) would be a technical correction to address errors
identified in the FY 2016 and FY 2019 Hospice Wage Index and Payment
Rate Update final rules, (80 FR 47186 and 83 FR 38636). In the FY 2016
Hospice final rule (80 FR 47186) adopted seven factors for measure
removal, and in the FY 2019 Hospice final rule (83 FR 38636) adopted
the eighth factor for measure removal. In those final rules, we
referenced the measure removal factors in the preamble but
inadvertently omitted them from the regulations text. Thus, these
measure removal factors identify how measures are removed from the
HQRP. Section 418.312(b)(3) would include the eight measure removal
factors as follows:
CMS may remove a quality measure from the Hospice QRP based on one
or more of the following factors:
[[Page 19741]]
(1) Measure performance among hospices is so high and unvarying
that meaningful distinctions in improvements in performance can no
longer be made.
(2) Performance or improvement on a measure does not result in
better patient outcomes.
(3) A measure does not align with current clinical guidelines or
practice.
(4) The availability of a more broadly applicable (across settings,
populations, or conditions) measure for the particular topic.
(5) The availability of a measure that is more proximal in time to
desired patient outcomes for the particular topic.
(6) The availability of a measure that is more strongly associated
with desired patient outcomes for the particular topic.
(7) Collection or public reporting of a measure leads to negative
unintended consequences other than patient harm.
(8) The costs associated with a measure outweigh the benefit of its
continued use in the program.
We solicit public comment on our proposal to revise the regulation
at Sec. 418.312(b) to add paragraphs (b)(1) through (3) to include
administrative data as part of the HQRP, and correct technical errors
identified in the FY 2016 and 2019 Hospice Wage Index and Payment Rate
Update final rules.
6. Update Regarding the Hospice Outcomes & Patient Evaluation (HOPE)
Development
As finalized in the FY 2020 Hospice Wage Index and Payment Rate
Update and Hospice Quality Reporting Requirements final rule (84 FR
38484), we are developing a hospice patient assessment instrument
identified as the HOPE. This tool is intended to help hospices better
understand care needs throughout the patient's dying process and
contribute to the patient's plan of care. It will assess patients in
real-time, based on interactions with the patient. The HOPE will
support quality improvement activities and calculate outcome and other
types of quality measures in a way that mitigates burden on hospice
providers and patients. Our two primary objectives for the HOPE are to
provide quality data for the HQRP requirements through standardized
data collection, and to provide additional clinical data that could
inform future payment refinements.
We anticipate that the HOPE will replace the HIS. The HIS is not a
patient assessment instrument. HIS data collection ``consists of
selecting responses to HIS items in conjunction with patient assessment
activities or via abstraction from the patient's clinical record.''
(HIS Manual v.2.01). In contrast, the HOPE is a patient assessment
instrument, designed to capture patient and family care needs in real-
time during patient interactions throughout the patient's hospice stay,
with the flexibility to accommodate patients with varying clinical
needs. The HOPE will enable CMS and hospices to understand the care
needs of people through the dying process, supporting provider care
planning and quality improvement efforts, and ensuring the safety and
comfort of individuals enrolled in hospice nationwide. The HOPE will
include key items from the HIS along with Standardized Patient
Assessment Data Elements (SPADEs), and demographics like gender and
race. This approach to include key aspects of SPADES and demographics
supports hospice feedback provided in the FYs 2017 and 2018 Hospice
Wage Index and Payment Rate Update final rule (81 FR 52171 and 82 FR
36669) and CMS' goals for a hospice assessment instrument, as stated in
the FY 2018 Hospice Wage Index and Payment Rate Update final rule. The
HOPE assessment instrument would facilitate communication among
providers and to measure the care of patient populations across
settings. While the standardization of measures required for adoption
under the IMPACT Act of 2014 is not applicable to hospices, it makes
reasonable sense to include those standardized elements and items that
appropriately and feasibly apply to hospice. After all, some patients
may move through the healthcare system to hospice so capturing and
tracking key SPADES and social risk factor items that apply to hospice,
including some of the categories of SPADES identified in the IMPACT Act
of 2014, may help CMS achieve our goals for continuity of care, overall
patient care and well-being, interoperability, and health equity that
are also discussed in this rule.
The draft HOPE has undergone cognitive and pilot testing, and will
undergo field testing to establish reliability, validity and
feasibility of the assessment instrument. We anticipate proposing the
HOPE in future rulemaking after testing is complete.
We will continue development of the HOPE assessment in accordance
with the Blueprint for the CMS Measures Management System. Development
of the HOPE is grounded in extensive information gathering activities
to identify and refine hospice assessment domains and candidate
assessment items. We appreciate the industry's and national
associations' engagement in providing input through information sharing
activities, including expert interviews, key stakeholder interviews,
and focus groups to support the HOPE development. As CMS proceeds with
field testing the HOPE, we will continue to engage with stakeholders
through sub-regulatory channels. In particular, we will continue to
host HQRP Forums to allow hospices and other interested parties to
engage with us on the latest updates and ask questions on the
development of the HOPE and related quality measures. We also have a
dedicated email account, [email protected], for comments
about the HOPE. We will use field test results to create a final
version of the HOPE to propose in future rulemaking for national
implementation. We will continue to engage all stakeholders throughout
this process. We appreciate the support for the HOPE and reiterate our
commitment to providing updates and engaging stakeholders through sub-
regulatory means. Future updates and engagement opportunities regarding
HOPE can be found at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/HOPE.html.
7. Update on Quality Measure Development for Future Years
In the FY 2017 Hospice Wage Index and Payment Rate Update final
rule (81 FR 52160), we finalized new policies and requirements related
to the HQRP, including how we would provide updates related to the
development of new quality measures. Information on the current HQRP
quality measures can be found at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures. In this proposed rule, we are continuing to provide
updates for both HOPE-based and claims-based quality measure
development.
To support new measure development, our contractor, Abt Associates,
convened TEP meetings in 2020 to provide feedback on several measure
concepts. In 2020, the TEP explored potential quality measure
constructs that could be derived from the HOPE and their
specifications. Specifically, for HOPE-based measure development, the
TEP focused on pain and other symptom outcome measure concepts that
could be calculated from the HOPE. Input from initial TEP workgroups
held in spring 2020 informed follow-up information-gathering activities
related to pain in general and neuropathic pain in particular. The 2020
Information
[[Page 19742]]
Gathering Summary report is available at https://www.cms.gov/files/document/12042020-information-gathering-oy1508.pdf. During fall 2020,
the TEP reviewed measure concepts focusing on pain and symptom outcomes
that could be calculated from HOPE items.
The TEP supported further exploration and development of these
measures. As described in the 2020 TEP Summary Report, the TEP
generally supports the following measure concepts that are calculated
using HOPE items: Timely Reduction of Pain Impact, Reduction in Pain
Severity, and Timely Reduction of Symptoms. The candidate measure
Timely Reduction of Pain Impact reports the percentage of patients who
experienced a reduction in the impact of moderate or severe pain. HOPE
items assessing Symptom Impact, and Patient Desired Tolerance Level for
Symptoms or Patient Preferences for Symptom Management were used to
calculate this measure. The candidate measure Reduction in Pain
Severity reports the percentage of patients who had a reduction in
reported pain severity. The primary HOPE items used to calculate this
measure include Pain Screening, Pain Active Problem, and Patient
Desired Tolerance Level for Symptoms or Patient Preferences for Symptom
Management. The last candidate measure discussed by the TEP was Timely
Reduction of Symptoms which measures the percentage of patients who
experience a reduction in the impact of symptoms other than pain. The
HOPE items assessing Symptom Impact, and Patient Desired Tolerance
Level for Symptoms or Patient Preferences for Symptom Management were
used to calculate this measure. The HOPE items for all three measure
are collected at multiple time points across a patient's stay,
including at Admission, Symptom Reassessment, Level of Care Change, and
Recertification. Overall, the TEP supported each candidate measure and
agreed that they were viable for distinguishing hospice quality. We
continue to develop all three candidate quality measures.
We are interested in exploring patient preferences for symptom
management, addressing patient spiritual and psychosocial needs, and
medication management in outcomes of care in development of quality
measures. We seek public comment, methods, instruments, or brief
summaries on hospice quality initiatives related to goal attainment,
patient preferences, spiritual needs, psychosocial needs, and
medication management.
Information about the TEP feedback on these quality measures
concepts and future measure concepts can be obtained via: https://www.cms.gov/files/document/2020-hqrp-tep-summary-report.pdf. Related to
the outcome measures and in order to have HOPE pain and symptom
measures in the program as soon as possible, we plan to develop process
measures, including on pain and symptom management. These process
measures may support or complement the outcome measures. We solicit
comments on current HOPE-based quality measure development and
recommendations for future process and outcome measure constructs.
In the FY 2020 Hospice Wage Index and Payment Rate Update final
rule (84 FR 38484) and as discussed below, we are interested in claims-
based quality measures in order to leverage the multiple data sources
currently available to support quality measure development.
Specifically, we intend to develop additional claims-based measures
that may enable beneficiaries and their family caregivers to make more
informed choices about hospice care and to hold hospices more
accountable for the care they provide. As discussed in this section,
the HVLDL and HCI claims-based measures support the Meaningful Measures
initiative and address gaps in HQRP. Additional claim-based measure
concepts we are considering for development include hospice services on
weekends, transitions after hospice live discharge, Medicare
expenditures per beneficiary (including the share of non-hospice
spending during hospice election, and the share for hospice care prior
to the last year of life), and post-mortem visits as measures of
hospice quality. We intend to submit additional claims-based measures
for future consideration and solicit public comment.
We solicit public comment on the aforementioned HOPE- and claims-
based quality measures to distinguish between high- and low-quality
hospices, support healthcare providers in quality improvement efforts,
and provide support to hospice consumers in helping to select a hospice
provider. We solicit public comment on how the candidate measures may
achieve those goals.
We are also considering developing hybrid quality measures that
would be calculated using claims, assessment (HOPE), or other data
sources. Hybrid quality measures allow for a more comprehensive set of
information about care processes and outcomes than can be calculated
using claims data alone. Assessment data can be used to support risk-
adjustment. We seek public comment on quality measure concepts and
considerations for developing hybrid measures based on a combination of
data sources.
8. CAHPS Hospice Survey Participation Requirements for the FY 2023 APU
and Subsequent Years
a. Background and Description of the CAHPS Hospice Survey
The CAHPS Hospice Survey is a component of the CMS HQRP which is
used to collect data on the experiences of hospice patients and the
primary caregivers listed in their hospice records. Readers who want
more information about the development of the survey, originally called
the Hospice Experience of Care Survey, may refer to 79 FR 50452 and 78
FR 48261. National implementation of the CAHPS Hospice Survey commenced
January 1, 2015 as stated in the FY 2015 Hospice Wage Index and Payment
Rate Update final rule (79 FR 50452).
b. Overview of the ``CAHPS Hospice Survey Measures''
The CAHPS Hospice Survey measures was re-endorsed by NQF on
November 20, 2020. The re-endorsement can be found on the NQF website
at: https://www.qualityforum.org/Measures_Reports_Tools.aspx. Use the
QPS tool and search for NQF number 2651. The survey received its
initial NQF endorsement on October 26, 2016 (NQF #2651). We adopted 8
survey based measures for the CY 2018 data collection period and for
subsequent years. These eight measures are publicly reported on a
designated CMS website, Care Compare, https://www.medicare.gov/care-compare/.
c. Data Sources
We previously finalized the participation requirements for the
CAHPS Hospice Survey, (84 FR 38484). We propose no changes to these
requirements going forward.
d. Public Reporting of CAHPS Hospice Survey Results
We began public reporting of the results of the CAHPS Hospice
Survey on Hospice Compare as of February 2018. Prior to the COVID-19
public health emergency (PHE), we reported the most recent 8 quarters
of data on the basis of a rolling average, with the most recent quarter
of data being added and the oldest quarter of data removed from the
averages for each data refresh. Given the exemptions provided due to
COVID-19 PHE in the March 27, 2020 Guidance Memorandum,\52\ public
reporting will
[[Page 19743]]
continue to be the most recent 8 quarters of data, excluding the
exempted quarters; Quarter 1 and Quarter 2 of CY 2020. More information
about this is detailed in the section entitled: Proposal for Public
Reporting CAHPS-based measures with Fewer than Standard Numbers of
Quarters Due to PHE Exemptions.
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\52\ https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
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e. Volume-Based Exemption for CAHPS Hospice Survey Data Collection and
Reporting Requirements
We previously finalized a volume-based exemption for CAHPS Hospice
Survey Data Collection and Reporting requirements for FY 2021 and every
year thereafter (84 FR 38526).
We propose no changes to this exemption. The exemption request form
is available on the official CAHPS Hospice Survey website: http://www.hospiceCAHPSsurvey.org. Hospices that intend to claim the size
exemption are required to submit to CMS their completed exemption
request form by December 31, of the data collection year.
Hospices that served a total of fewer than 50 survey-eligible
decedent/caregiver pairs in the year prior to the data collection year
are eligible to apply for the size exemption. Hospices may apply for a
size exemption by submitting the size exemption request form as
outlined above. The size exemption is only valid for the year on the
size exemption request form. If the hospice remains eligible for the
size exemption, the hospice must complete the size exemption request
form for every applicable FY APU period, as shown in table 19.
[GRAPHIC] [TIFF OMITTED] TP14AP21.026
f. Newness Exemption for CAHPS Hospice Survey Data Collection and
Public Reporting Requirements
We previously finalized a one-time newness exemption for hospices
that meet the criteria as stated in the FY 2017 Hospice Wage Index and
Payment Rate Update final rule (81 FR 52181). In the FY 2019 Hospice
Wage Index and Payment Rate Update final rule (83 FR 38642), we
continued the newness exemption for FY 2023, and all subsequent years.
We encourage hospices to keep the letter they receive providing them
with their CMS Certification Number (CCN). The letter can be used to
show when you received your number.
g. Survey Participation Requirements
We previously finalized survey participation requirements for FY
2022 through FY 2025 as stated in the FY 2018 and FY 2019 Hospice Wage
Index and Payment Rate Update final rules (82 FR 36670 and 83 FR 38642
through 38643). We also continued those requirements in all subsequent
years (84 FR 38526). Table 20 restates the data submission dates for FY
2023 through FY 2025.
[[Page 19744]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.027
For further information about the CAHPS Hospice Survey, we
encourage hospices and other entities to visit: https://www.hospiceCAHPSsurvey.org. For direct questions, contact the CAHPS
Hospice Survey Team at [email protected] or call 1-(844)
472-4621.
h. Proposal To Add CAHPS Hospice Survey Star Ratings to Public
Reporting
CMS currently publishes CAHPS star ratings for several of its
public reporting programs including Home Health CAHPS and Hospital
CAHPS. The intention in doing so is to provide a simple, easy to
understand, method for summarizing CAHPS scores. Star ratings benefit
the public in that they can be easier for some to understand than
absolute measure scores, and they make comparisons between hospices
more straightforward. The public's familiarity with a 1 through 5 star
rating system, given its use by other programs, is also a benefit to
using this system.
We propose to introduce Star Ratings for public reporting of CAHPS
Hospice Survey results on the Care Compare or successor websites no
sooner than FY 2022. We propose that the calculation and display of the
CAHPS Hospice Survey Star Ratings be similar to that of other CAHPS
Star Ratings programs such as Hospital CAHPS and Home Health CAHPS. The
stars would range from one star (worst) to five stars (best). We
propose that the stars be calculated based on ``top-box'' scores for
each of the eight CAHPS Hospice Survey measures. Specifically,
individual-level responses to survey items would be scored such that
the most favorable response is scored as 100 and all other responses
are scored as 0. A hospice-level score for a given survey item would
then be calculated as the average of the individual-level responses,
with adjustment for differences in case mix and mode of survey
administration. For a measure composed of multiple items, the hospice-
level measure score is the average of the hospice-level scores for each
item within the measure. Similar to other CAHPS programs, we propose
that the cut-points used to determine the stars be constructed using
statistical clustering procedures that minimize the score differences
within a star category and maximize the differences across star
categories.
We propose to use a two-stage approach to calculate these cut-
points. In the first stage, we would determine initial cut-points by
calculating the clustering algorithm among hospices with 30 or more
completed surveys over 2 quarters (that is, 6 months); restricting
these calculations to hospices that meet a minimum sample size promotes
stability of cut-points. Depending on whether hospices that meet this
minimum sample size have different score patterns than smaller
hospices, the initial cut-points may be too high or too low. To ensure
that cut-points reflect the full distribution of measure performance,
in the second stage, we would compare mean measure scores for the
bigger hospices used in the first stage to all other hospices, and
update cut-points by adjusting the initial cut-points to reflect the
normalized difference between bigger and smaller hospices. This two-
stage approach allows for calculation of stable cut-points that reflect
the full range of hospice performance. We propose that hospice star
ratings for each measure be assigned based on where the hospice-level
measure score falls within these cut-points.
We further propose to calculate a summary or overall CAHPS Hospice
Survey Star Rating by averaging the Star Ratings across the 8 measures,
with a weight of \1/2\ for Rating of the Hospice, a weight of \1/2\ for
Willingness to Recommend the Hospice, and a weight of 1 for each of the
other measures, and then rounding to a whole number. We propose that
only the overall Star Rating be publicly reported and that hospices
must have a minimum of 75 completed surveys in order to be assigned a
Star Rating. We propose to publish the details of the Star Ratings
methodology on the CAHPS Hospice Survey website,
www.hospicecahpssurvey.org. CMS requires no additional resources to
create and display CAHPS star ratings.
We solicit comments on these proposals for CAHPS Star Ratings and
included in public reporting no sooner than FY 2022.
[[Page 19745]]
9. Form, Manner, and Timing of Quality Data Submission
a. Background
Section 1814(i)(5)(C) of the Act requires that each hospice submit
data to the Secretary on quality measures specified by the Secretary.
Such data must be submitted in a form and manner, and at a time
specified by the Secretary. Section 1814(i)(5)(A)(i) of the Act was
amended by the CAA 2021 and the payment reduction for failing to meet
hospice quality reporting requirements is increased from 2 percent to 4
percent beginning with FY 2024. The Act requires that, beginning with
FY 2014 through FY 2023, the Secretary shall reduce the market basket
update by 2 percentage points and then beginning in FY 2024 and for
each subsequent year, the Secretary shall reduce the market basket
update by 4 percentage points for any hospice that does not comply with
the quality data submission requirements for that FY.
b. Compliance
HQRP Compliance requires understanding three timeframes for both
HIS and CAHPS. (1) The relevant Reporting Year, payment FY and the
Reference Year. The ``Reporting Year'' (HIS)/``Data Collection Year''
(CAHPS). This timeframe is based on the CY. It is the same CY for both
HIS and CAHPS. If the CAHPS Data Collection year is CY 2022, then the
HIS reporting year is also CY 2022. (2) The APU is subsequently applied
to FY payments based on compliance in the corresponding Reporting Year/
Data Collection Year. (3) For the CAHPS Hospice Survey, the Reference
Year is the CY prior to the Data Collection Year. The Reference Year
applies to hospices submitting a size exemption from the CAHPS survey
(there is no similar exemption for HIS). For example, for the CY 2022
data collection year, the Reference Year, is CY 2021. This means
providers seeking a size exemption for CAHPS in CY 2022 would base it
on their hospice size in CY 2021. Submission requirements are codified
in Sec. 418.312.
For every CY, all Medicare-certified hospices are required to
submit HIS and CAHPS data according to the requirements in Sec.
418.312. Table 21 summarizes the three timeframes described above. It
illustrates how the CY interacts with the FY payments, covering the CY
2020 through CY 2023 data collection periods and the corresponding APU
application from FY 2022 through FY 2025.
[GRAPHIC] [TIFF OMITTED] TP14AP21.028
As illustrated in Table 21, CY 2020 data submissions compliance
impacts the FY 2022 APU. CY 2021 data submissions compliance impacts
the FY 2023 APU. CY 2022 data submissions compliance impacts FY 2024
APU. This CY data submission impacting FY APU pattern follows for
subsequent years.
c. Submission Data and Requirements
As finalized in the FY 2016 Hospice Wage Index and Payment Rate
Update final rule (80 FR 47192), hospices' compliance with HIS
requirements beginning with the FY 2020 APU determination (that is,
based on HIS-Admission and Discharge records submitted in CY 2018) are
based on a timeliness threshold of 90 percent. This means CMS requires
that hospices submit 90 percent of all required HIS records within 30-
days of the event (that is, patient's admission or discharge). The 90-
percent threshold is hereafter referred to as the timeliness compliance
threshold. Ninety percent of all required HIS records must be submitted
and accepted within the 30-day submission deadline to avoid the
statutorily-mandated payment penalty.
To comply with CMS' quality reporting requirements for CAHPS,
hospices are required to collect data monthly using the CAHPS Hospice
Survey. Hospices comply by utilizing a CMS-approved third-party vendor.
Approved Hospice CAHPS vendors must successfully submit data on the
hospice's behalf to the CAHPS Hospice Survey Data Center. A list of the
approved vendors can be found on the CAHPS Hospice Survey website:
www.hospicecahpssurvey.org. Table 22. HQRP Compliance Checklist
illustrates the APU and timeliness threshold requirements.
[[Page 19746]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.029
Most hospices that fail to meet HQRP requirements do so because
they miss the 90 percent threshold. We offer many training and
education opportunities through our website, which are available 24/7,
365 days per year, to enable hospice staff to learn at the pace and
time of their choice. We want hospices to be successful with meeting
the HQRP requirements. We encourage hospices to use this website at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Quality-Reporting-Training-Training-and-Education-Library.
For more information about HQRP Requirements, please visit the
frequently-updated HQRP website and especially the Best Practice,
Education and Training Library, and Help Desk web pages at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting. We also encourage members of the
public to go to the HQRP web page and sign-up for the Hospice Quality
ListServ to stay informed about HQRP.
d. Update on Transition to iQIES
In the FY 2020 Hospice Wage Index and Payment Rate Update final
rule (84 FR 38484), we finalized the proposal to migrate our systems
for submitting and processing assessment data. Hospices are currently
required to submit HIS data to CMS using the Quality Improvement and
Evaluation System (QIES) Assessment and the Submission Processing
(ASAP) system. The FY 2020 Hospice Wage Index and Payment Rate Update
final rule (84 FR 38484) finalized the proposal to migrate to a new
internet Quality Improvement and Evaluation System (iQIES) that will
enable us to make real-time upgrades. We are designating that system as
the data submission system for the Hospice QRP. We will notify the
public about any system migration updates using subregulatory
mechanisms such as web page postings, listserv messaging, and webinars.
10. Public Display of ``Quality Measures'' and Other Hospice Data for
the HQRP
a. Background
Under section 1814(i)(5)(E) of the Act, the Secretary is required
to establish procedures for making any quality data submitted by
hospices available to the public. These procedures shall ensure that
individual hospices have the opportunity to review their data prior to
these data being made public on our designated public website. To meet
the Act's requirement for making quality measure data public, we
launched Hospice Compare in August 2017. This website allows consumers,
providers, and other stakeholders to search for all Medicare-certified
hospice providers and view their information and quality measure
scores. In September 2020, CMS transitioned Hospice Compare to the Care
Compare website. Hospice Compare was discontinued in December 2020.
Care Compare supports all Medicare settings and fulfills the Act's
requirements for the HQRP. For more information about Care Compare,
please see the Update on the Hospice Quality Reporting Requirements for
FY 2022 in section D.
Since 2017, we have increased and improved available information
about the care hospices provide for consumers. To indicate the quality
of care hospices provide, we first posted the seven HIS Measures (NQF
#1641, NQF #1647, NQF #1634, NQF #1637, NQF #1639, NQF #1638, and NQF
#1617) in 2017, and then added the CAHPS Hospice Survey measure (NQF
#2651) and the HIS Comprehensive Assessment at Admission (NQF #3235) in
2018. In 2019, we added the Hospice Visits When Death is Imminent
(Measure 1) to the website.
As discussed above, we propose to remove the seven HIS Measures
from public reporting on Care Compare no earlier than May 2022. The
Hospice Item Set V3.00 PRA Submission replaced the HVWDII measure with
a more robust version: The claims-based measure HVLDL. We propose to
publicly report the HVLDL no earlier than May 2022. We are also
proposing to publicly report the HCI, another claims-based measure no
earlier than May 2022. In addition to the publicly-reported quality
measure data, in 2019 we added to public reporting, information about
the hospices' characteristics, taking raw data available from the
Medicare Public Use File and other publicly-available government data
sources and making them more consumer friendly and accessible for
people seeking hospice care for themselves or family members, (83 FR
38649). This publicly reported information currently includes
diagnoses, location of care, and levels of care provided.
[[Page 19747]]
b. Proposal Regarding Data Collection and Reporting During a Public
Health Emergency
(1). Background: COVID-19 Public Health Emergency Temporary Exemption
and Its Impact on the Public Reporting Schedule
Under authority of section 319 of the Public Health Service (PHS)
Act, the Secretary declared a Public Health Emergency (PHE) effective
as of January 27, 2020. On March 13, 2020, the President declared a
national state of emergency under the Stafford Act, effective March 1,
2020, allowing the Secretary to invoke section 1135(b) of the Act (42
U.S.C. 1320b-5) to waive or modify the requirements of titles XVIII,
XIX, and XXI of the Act and regulations to the extent necessary to
address the COVID-19 PHE. Many waivers and modifications were made
effective as of March 1, 2020 53 54 in accordance with the
president's declaration. On March 27, 2020, we sent a guidance
memorandum under the subject title, ``Exceptions and Extensions for
Quality Reporting Requirements for Acute Care Hospitals, PPS-Exempt
Cancer Hospitals, Inpatient Psychiatric Facilities, Skilled Nursing
Facilities, Home Health Agencies, Hospices, Inpatient Rehabilitation
Facilities, Long-Term Care Hospitals, Ambulatory Surgical Centers,
Renal Dialysis Facilities, and MIPS Eligible Clinicians Affected by
COVID-19'' \55\ to the Medicare Learning Network (MLN) Connects
Newsletter and Other Program-Specific Listserv Recipients,\56\
hereafter referred to as the March 27, 2020 CMS Guidance Memorandum. In
that memo, which applies to HIS and CAHPS Hospice Survey, CMS granted
an exemption to the HQRP reporting requirements for Quarter 4 (Q4) 2019
(October 1, 2019 through December 31, 2019), Quarter 1 (Q1) 2020
(January 1, 2020 through March 30, 2020), and Quarter 2 (Q2) 2020
(April 1, 2020 through June 30, 2020). We discuss the impact to the HIS
here, and the impact to the CAHPS Hospice Survey further below. For
HIS, the quarters are defined based on submission of HIS admission or
discharge assessments.
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\53\ Azar, A.M. (2020 March 15). Waiver or Modification of
Requirements Under Section 1135 of the Social Security Act. Public
Health Emergency. https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
\54\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
\55\ https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
\56\ (2020, March 27). Exceptions and Extensions for Quality
Reporting Requirements for Acute Care Hospitals, PPS-Exempt Cancer
Hospitals, Inpatient Psychiatric Facilities, Skilled Nursing
Facilities, Home Health Agencies, Hospices, Inpatient Rehabilitation
Facilities, Long-Term Care Hospitals, Ambulatory Surgical Centers,
Renal Dialysis Facilities, and MIPS Eligible Clinicians Affected by
COVID-19. Centers for Medicare & Medicaid Services. https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
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The exemption has impacted the public reporting schedule. Since
launching Hospice Compare in 2017, HIS-measures have been reported
using 4 quarters of data. The 4 quarters included are the most recent
data that have gone through Review and Correct processes, have been
issued in a provider preview report, and have time allotted for
addressing requests for data suppression before being publicly
reported. As discussed in the FY 2017 Hospice Wage Index and Payment
Rate Update final rule (81 FR 52183), CMS requires at least 4 quarters
of data to establish the scientific acceptability for our HIS-based
quality measures. For CAHPS-based measures, we have reported CAHPS
measures using eight rolling quarters of data on Hospice Compare since
2018. In the FY 2017 Hospice Wage Index and Payment Rate Update final
rule (81 FR 52143), we stated that we would continue CAHPS reporting
with eight rolling quarters on an ongoing basis. This original public
reporting schedule included the exempted quarters of Q4 2019 and Q1 and
Q2 2020 in six refreshes for HIS and 11 refreshes for CAHPS. Table 23
displays the original schedule for public reporting prior to the COVID-
19 PHE.
[[Page 19748]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.030
During the spring and summer of 2020, we conducted testing to
inform decisions about publicly reporting data for those refreshes
which include exempt data. The testing helped us develop a plan for
posting data as early as possible, for as many hospices as possible,
and with scientific acceptability similar to standard threshold for
public reporting. The following sections provide the results of our
testing and explain how we used the results to develop a plan that we
believe allows us to achieve these objectives as best as possible.
(2). Update on Use of Q4 2019 Data and Data Freeze for Refreshes in
2021
In the March 27, 2020 Guidance Memorandum, we stated that we should
not include any post-acute care (PAC) quality data that are greatly
impacted by the exemption in the quality reporting programs. Given the
timing of the PHE onset, we determined that we would use any data that
was submitted for Q4 2019. We conducted analyses of those data to
ensure that their use was appropriate. In the original schedule (Table
23) the November 2020 refresh includes Q4 2019 data for HIS- and CAHPS-
based measures (Q1 through Q4 2019 for HIS data and Q1 2018 through Q4
2019 for CAHPS data) and is the last refresh before Q1 2020 data are
included. Before proceeding with the November 2020 refresh, we
conducted testing to ensure that, even though we made an exception to
reporting requirements for Q4 2019 in March 2020, public reporting
would still allow us to publicly report data for a similar number of
hospice providers, as compared to standard reporting. Specifically, we
compared submission rates in Q4 2019 to average annual rates (Q4 2018
through Q3 2019) to assess the extent to which hospices had taken
advantage of the exemption, and thus the extent to which data and
measure scores might be affected. We observed that the HIS data
submission rate for Q4 2019 was in fact 1.8 percent higher than the
previous CY (Q4 2018). For the CAHPS Hospice Survey, 2.1 percent more
hospices submitted data in Q4 2019 than in Q4 2018. We note that Q4
2019 ended before the onset of the COVID-19 PHE in the United States
(U.S.). Thus, we proceeded with including these data in measure
calculations for the November 2020 refresh.
As for Q1 and Q2 2020, we determined that we would not use HIS or
CAHPS data from these quarters for public reporting given the timing of
the PHE onset. All refreshes, during which we decided to hold these
data constant, included more than 2 quarters of data that were affected
by the CMS-issued COVID reporting exceptions; thus we did not have an
adequate amount of data to reliably calculate and publicly display
provider measures scores. Consequently, we determined to freeze the
data displayed, that is, holding data constant after the November 2020
refresh without subsequently updating the data through November 2021.
This decision was communicated to the public in a Public Reporting Tip
Sheet, which is located at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/HQRP-Requirements-and-Best-Practices.
[[Page 19749]]
(3). Proposal for Public Reporting of HIS-Based Measures With Fewer
Than Standard Numbers of Quarters Due to PHE Exemption in February 2022
As noted above, we used Q4 2019 data for public reporting in
November 2020 and froze that data for the February, May, August, and
November 2021 refreshes. This addressed five of the six PHE-affected
quarters for HIS-based measures, and five of the 11 PHE-affected
quarters of CAHPS-based measures.
Because November 2020 refresh data will become increasingly out-of-
date and thus less useful for consumers, we analyzed whether it would
be possible to use fewer quarters of data for the last refresh affected
by the exemption (February 2022) and thus more quickly resume public
reporting with updated quality data. Using fewer quarters of more
recent data, the first option, would require that (1) a sufficient
percentage of providers would still likely have enough assessment data
to report quality measures (reportability); and (2) fewer quarters
would likely produce similar measure scores for hospices, and thus not
unfairly represent the quality of care hospices provide during the
period reported in a given refresh (reliability). To assess these
criteria, we conducted reportability and reliability analysis using 3
quarters of data in a refresh, instead of the standard 4 quarters of
data for reporting HIS-based measures. Specifically, we used historical
data to calculate HIS-based quality measures under two scenarios:
Standard Public Reporting (SPR) Scenario: We used data
from the four quarters of CY 2019, which represent CY 2020 public
reporting in the absence of the temporary exemption from the submission
of PAC quality data, as the basis for comparing simulated alternatives.
For HIS-based measures, we used quarters Q1 through Q4 2019.
COVID-19 PHE Affected Reporting (CAR) Scenario: We
calculated quality measures using Q2 2019, Q3 2019, and Q4 2019 data,
to simulate using only Q3 2020, Q4 2020, and Q1 2021 data for public
reporting.
The HIS Comprehensive Assessment Measure is based on the receipt of
care processes at the time of admission. Therefore for the COVID-19
Affected Reporting (CAR) Scenario, we excluded data for patient stays
with admission dates in Q1 2019.
For each scenario, we calculated the reportability as the percent
of hospices meeting the 20-case minimum for public reporting (the
public reporting threshold). To test the reliability of restricting the
providers included in the Standard Public Reporting (SPR) Scenario to
those included in the CAR Scenario, we performed three tests. First, we
evaluated measure correlation using the Pearson and Spearman
correlation coefficients, which assess the alignment of hospices' HIS
Comprehensive Assessment Measure scores between scenarios. Second, for
each scenario, we conducted a split-half reliability analysis and
estimated intra-class correlation (ICC) scores, where higher scores
imply better internal reliability. Modest differences in ICC scores
between scenarios would suggest that using fewer quarters of data does
not impact the internal reliability of the results. Third, we estimated
reliability scores. A higher value in these scores indicates that HIS
Comprehensive Assessment Measure values are relatively consistent for
patients admitted to the same hospice and variation in the measure
reflects true differences across providers.
Testing results show that the CAR scenario--specifically using 3
quarters of data for the HIS Comprehensive Assessment Measure--
demonstrates acceptable levels of reportability and reliability. As
displayed in Table 24, the number of providers who met the public
reporting threshold for the HIS Comprehensive Assessment Measure
decreases by 236 (or by 5.2 percentage points) when reporting three
versus four quarters of data. In the FY 2014 Hospice Wage Index and
Payment Rate Update final rule (78 FR 48234) we stated that
reportability of 71 percent through 90 percent is acceptable. Therefore
using 3 quarters of data for the HIS Comprehensive Assessment Measure
would achieve acceptable reportability shown in Table 24.
[GRAPHIC] [TIFF OMITTED] TP14AP21.031
Table 24 indicates that the reliability of the HIS Comprehensive
Assessment Measure scores is similar for the CAR and SPR scenarios.
Testing also yielded correlation coefficients above 0.9, indicating a
high degree of agreement between hospices' HIS Comprehensive Assessment
Measure scores when using 3 or 4 quarters of data. The results also
show that the HIS Comprehensive Assessment Measure's ICC for CAR and
SPR scenarios are similar, with only a 0.02 difference. This implies
high internal reliability of the measure in both scenarios. The median
reliability scores for the HIS Comprehensive Assessment Measure are
also very similar in both CAR and SPR scenarios. This indicates that
scores estimated using 3 quarters of data continue to capture provider-
level differences and that admission-level scores remain consistent
within hospices.
[[Page 19750]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.032
In Table 25, we explore changes in hospices' relative rankings
between the SPR and CAR scenarios. For each scenario, we divided
hospices in quintiles based on their HIS Comprehensive Assessment
Measure score, such that higher scores are in a higher quintile.
Changes in a hospices' quintile from the SPR to CAR scenario would
indicate a re-ranking of hospices when using 3 quarters compared to 4
quarters. Over 93 percent of hospices remain in the same quintile,
suggesting that the ranking of hospices is fairly stable between the
SPR and CAR scenarios.
[GRAPHIC] [TIFF OMITTED] TP14AP21.033
We also used the results presented in Table 26 to assess the option
of reporting Q4 2019, Q3 2020, Q4 2020, and Q1 2021 for the February
2022 refresh. This option maintains requirements in the FY 2017 Hospice
Wage Index and Payment Update final rule for publicly reporting 4
quarters of data, but it requires using some data that are more than 2
years old. Also, the relatively high number of hospices that meet the
public reporting threshold in the CAR scenario, relative to the SPR
scenario, with just 3 quarters of data justify the use of 3 quarters in
the unusual circumstances of the PHE and its associated exemptions.
We propose that, in the COVID-19 PHE, we would use 3 quarters of
HIS data for the final affected refresh, the February 2022 public
reporting refresh of Care Compare for the Hospice setting. Using 3
quarters of data for the February 2022 refresh would allow us to begin
displaying Q3 2020, Q4 2020, and Q1 2021 data in February 2022, rather
than continue displaying November 2020 data (Q1 2019 through Q4 2019).
We believe that updating the data in February 2022 by more than a year
relative to the November 2020 freeze data would assist consumers by
providing more relevant quality data and allow hospices to demonstrate
more recent performance. Our testing results indicate we can achieve
these positive impacts while maintaining high standards for
reportability and reliability. Table 27 summarizes the comparison
between the original schedule for public reporting with the revised
schedule (that is, frozen data) and with the proposed schedule that is,
using 3 quarters in the February 2022 refresh.
We seek public comment on this proposal to use 3 quarters of HIS
data for the February 2022 public reporting refresh.
[[Page 19751]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.034
(4). Proposal for Public Reporting of ``CAHPS Hospice Survey-Based
Measures'' Due to PHE Exemption
Prior to COVID-19 PHE, the CAHPS Hospice Survey publicly reported
the most recent eight rolling quarters of data. We propose to continue
to report the most recent 8 quarters of available data after the
freeze, but not to include the data from the exempted quarters of Q1
and Q2 of 2020 as issued in the March 27, 2020 Guidance Memorandum with
the effected quarters discussed above. The optional data submission for
Q4 2019 results in publicly reporting of that data since the CAHPS
Hospice Survey from that quarter were not impacted. The data submitted
for Q4 2019 referred to deaths that occurred prior to COIVD-19. For the
CAHPS Hospice Survey, 2.1 percent more hospices submitted data in Q4
2019 than in the same quarter a year earlier.
Like HIS, our goal is to report as much of the most recent CAHPS
Hospice Survey data as possible, to display data for as many hospices
as possible, and to maintain the reliability of the data.
Similar to HIS, the CAHPS Hospice Survey reviewed the data for
reportability using fewer quarters than normal. However, we found that
using fewer than 8 quarters of data would have two important negative
impacts on public reporting. First, it would reduce the proportion of
hospices that would have CAHPS Hospice Survey data displayed on Care
Compare. An analysis of the 8 quarters of data from Q1 2018 through Q4
2019 (publicly reported in November 2020) shows there were 5,041 active
hospices. Of these hospices: 2,941 (58.3 percent) had 30+ completes for
those 8 quarters, and had scores publicly reported. Fewer hospices,
2,328 (46.2 percent), would have had 30+ completes if 4 quarters of
data were used to calculate scores and 1,970 (39.1 percent) would have
30+ completes if 3 quarters were used to calculate scores. In addition,
the overall reliability of the CAHPS scores would decline with fewer
quarters of data. For these reasons, we determined the best course of
action would be to continue to publicly report the most recent 8
quarters of data, but exempting Q1 and Q2 2020. This will allow us to
maximize the number of hospices that will have CAHPS scores displayed
on Care Compare, protect the reliability of the data, and report as
much of the most recent data as possible.
CMS froze CAHPS data starting with the November 2020 refresh and
concluding with the November 2021 refresh. We propose that starting
with the February 2022 refresh, CMS will display the most recent 8
quarters of CAHPS Hospice Survey data, excluding Q1 and Q2 2020. We
will resume public reporting by displaying 3 quarters of post-exemption
data, plus five quarters of pre-exemption data. (Please see Table 28.)
We propose that in each refresh subsequent to February 2022, we will
report one more post-exemption quarter of data and one fewer pre-
exemption quarter of data until we reach eight quarters of post-
exemption data in May of 2023. We further propose that as of August
2023, we will resume reporting a rolling average of the most recent 8
quarters of data. Table 28 specifies the quarters for each refresh.
This will allow us to report the maximum amount of new data, maintain
reliability of the data, and permit the maximum number of hospices to
receive scores. In addition, Table 28 shows the proposed CAHPS public
reporting schedule during and after the data freeze.
[[Page 19752]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.035
We seek public comment on this proposal to publicly report the
most-recently available 8 quarters of CAHPS data starting with the
February 2022 refresh and going through the May 2023 refresh on Care
Compare because we cannot publicly report Q1 2020 and Q2 2020 data due
to the COVID-19 PHE.
c. Quality Measures To Be Displayed on Care Compare in FY 2022 and
Beyond
(1). Proposal To Remove Seven ``Hospice Item Set Process Measures''
From Public Reporting
As discussed earlier, we are proposing to remove the seven HIS
process measures from the HQRP as individual measures, and no longer
applying them to the FY 2024 APU and thereafter. We propose to remove
the seven HIS process measures no earlier than May 2022 refresh from
public reporting on Care Compare and from the Preview Reports but
continue to have it publicly available in the data catalogue at https://data.cms.gov/provider-data/topics/hospice-care. We are seeking public
comment on this proposal to remove the seven HIS process measures from
public reporting on Care Compare.
(2). Proposals for Calculating and Publicly Reporting ``Claims-Based
Measure'' as Part of the HQRP
In the HIS V3.00 Paperwork Reduction Act Submission (OMB control
number: 0938-1153, CMS-10390), we finalized a proposal to adopt HVLDL
into the HQRP for FY 2021. We are also proposing in this rule,
discussed above, to adopt the HCI into the HQRP for FY2022. In this
section, we present four proposals related to calculating and reporting
claims-based measures, with specific application to HVLDL and HCI.
First, we propose to extract claims data to calculate claims-based
measures at least 90 days after the last discharge date in the
applicable period, which we will use for quality measure calculations
and public reporting on Care Compare. For example, if the last
discharge date in the applicable period for a measure is December 31,
2022, for data collection January 1, 2022, through December 31, 2022,
we would create the data extract on approximately March 31, 2023, at
the earliest. We would use those data to calculate and publicly report
the claims-based measures for the CY2022 reporting period. This
proposal is similar to those finalized in other PAC settings, including
the CY 2017 Home Health Prospective Payment System final rule (81 FR
76702), FY 2017 Inpatient Rehabilitation Facility Prospective Payment
System final rule (81 FR 52056), and the FY 2017 Long Term Care
Hospital Prospective Payment System final rule (81 FR 56762).
The proposed timeframe allows us to balance providing timely
information to the public with calculating the claims-based measures
using as complete a data set as possible. We recognize that the
proposed approximately 90-day ``run-out'' period is shorter than the
Medicare program's current timely claims filing policy under which
providers have up to 1 year from the date of discharge to submit
claims. However, several months lead-time is necessary after acquiring
the data to conduct the claims-based calculations. If we were to delay
our data extraction point to 12 months after the last date of the last
discharge in the applicable period, we would not be able to deliver the
calculations to hospices sooner than 18 to 24 months after the last
discharge.
To implement this process, hospices would not be able to submit
corrections to the underlying claims snapshot or add claims (for those
claims-based measures) to this data set at the
[[Page 19753]]
conclusion of the 90-day period following the last date of discharge
used in the applicable period. Therefore, we would consider the hospice
claims data to be complete for purposes of calculating the claims-based
measures at this point. Thus, it is important that hospices ensure the
completeness and correctness of their claims prior to the claims
``snapshot.''
Second, we propose that we will update the claims-based measures
used for the HQRP annually. Specifically, we will refresh claims-based
measure scores on Care Compare, in preview reports, and in the
confidential CASPER QM preview reports annually. This periodicity of
updates aligns with most claims-based measures across PAC settings.
Third, we propose that we will calculate claims-based measure
scores based on one or more years of data. We considered several
factors to determine the number of years to include in measure
calculations. Using only 1 year (4 quarters) of data, as is currently
done for HIS-based quality measures reported on Care Compare, allows us
to share with the public only the most up-to-date information and best
reflects current realities. Having only the most recent data can also
help incentivize hospices with lower scores to make changes and have
the results of their effort be reflected in better scores.
At the same time, we want to report measures scores to the public
for as many hospices as possible, including small hospices. Currently,
only Medicare-certified hospices with more than 20 discharges each year
have quality measure results publicly available on Care Compare. This
public reporting threshold protects the privacy of patients who seek
care at smaller hospices. However, due to the threshold, at least some
hospices will not achieve the minimum patient discharges within 1 year.
This means that their scores will not be displayed on Care Compare, and
consumers will not have information about them to inform their
decisions about selecting a hospice. Using more years of data allows
more of these hospices to meet this threshold.
We conducted reportability testing for HCI and HVLDL to help us
consider how best to balance the need for recent data with the need for
transparency in reporting the HQRP claims-based measures. Specifically,
we conducted a simulation using 2 years of data. We then calculated the
change in the number of hospices which achieved the minimum reporting
standard. We also compared the measure scores of the hospices that meet
the reporting threshold when we use 2 years of data with hospices that
meet the threshold using only 1 year of data.
Results for both HCI and HVLDL indicate that using 2 years of data
increases reportability. For HVLDL, combining 2 years of data (FY 2018
to FY 2019) allows an additional 326 hospices to share measure scores,
or 33.8 percent of the hospices that do not meet the reporting
threshold in FY 2019 alone. For HCI, combining 2 years of data (FY 2018
to FY 2019 data) allows an additional 277 to report HCI measure scores
on Care Compare, or 43.2 percent of the hospices that do not meet the
reporting threshold in FY 2019 alone.
[GRAPHIC] [TIFF OMITTED] TP14AP21.036
Our simulations indicate that the hospices that only meet the
reporting threshold when using 2 years of data have performance scores
substantially lower than average. For HVLDL, where higher scores
indicate better quality of care, the national average score was 65.5
percent in FY 2019, where 965 hospices did not meet the reportability
threshold. After pooling data using FY 2018 to FY 2019, 326 additional
hospices met the reportability threshold, or 33.8 percent of those
previously missing. Those addition 326 hospices had an average HVLDL
score of just 43.3 percent, about 20 percentage points lower than the
hospices meeting the reportability threshold using FY 2019 alone
national average score for this HVLDL measure.
The results for HCI similarly show that the hospices with
reportable data when using two-pooled years of data had lower HCI
scores compared to the national average when using just FY 2019 data.
Higher HCI scores indicate better performance. As Figure 7 shows, a
larger numbers of hospices among the 277 hospices that only meet the
reporting threshold when using 2 years of data had HCI scores between
four and eight, while a larger number of hospices in the FY 2019
population had a perfect score of 10.
[[Page 19754]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.037
Given these findings, we propose using 2 years of data to publicly
report HCI and HVLDL in 2022. The use of 2 years or 8 quarters of
quality data is already publicly reported for the quality measures
related to the CAHPS Hospice Survey so hospices are familiar with this
approach. We plan to consider multiple years of data, like the 2 years
of data, for other claims-based measures proposed in subsequent years.
We believe it is important to support consumers by sharing information
on the performance of hospices that have lower scores, and to
incentivize those hospices to improve. The results demonstrate that
using multiple years of data help include more hospices that have lower
performance rates for HVLDL and HCI in public reporting on Care
Compare. While using more years of data would allow us to report
measures for even more hospices, it would involve sharing data that are
no longer relevant, and display scores that do not reflect recent
hospice improvement efforts.
We are soliciting public comment on these proposals related to the
using 2 years of data for claims-based measures and public reporting of
claims measures in general and their application to HVLDL and HCI
specifically.
(3). Proposal To Publicly Report the Hospice Care Index and ``Hospice
Visits in the Last Days of Life'' Claims-Based Measures
As discussed previously, we are proposing to publicly report the
HCI and HVLDL using 2 years, which is 8 quarters of Medicare claims
data. We propose to publicly report the HCI and HVLDL beginning no
earlier than May 2022 using FY2021 Medicare hospice claims data, and to
include it in the Preview Reports no sooner than the May 2022 refresh.
The publicly-reported version of HCI on Care Compare will only include
the final HCI score, and not the component indicators. The Preview
Reports will reflect the HCI as publicly reported. We are seeking
public comment on this proposal for HCI and HVLDL public reporting on
Care Compare no sooner than May 2022.
(4). Update on Publicly Reporting for the ``Hospice Visits When Death
is Imminent (HVWDII) Measure 1'' and the ``Hospice Visits in the Last
Days of Life (HVLDL) Measure''
As discussed earlier, the HIS V3.00 PRA Submission, CMS-10390 (OMB
control number: 0938-1153), finalized the proposal to replace the
HVWDII measure pair with a re-specified version called HVLDL, which is
a single measure based on Medicare claims. Relatedly, in the HIS V3.00
PRA Submission, CMS-10390 (OMB control number: 0938-1153), we finalized
the proposal to remove Section O from the HIS. As stated in section
1814(i)(5)(E) of the Act, we establish procedures for making all
quality data submitted by hospices under Sec. 418.312 available to the
public. Thus, we would have continued to publicly report HVWDII Measure
1 data through the November 2021 refresh. Because of the data freeze
detailed above, HVWDII Measure 1 data from the November 2020 refresh,
covering HIS admissions during Q1 through Q4 2019, will be publicly
displayed for all calendar year 2021 refreshes. We may retain the
November 2020 refresh for HVWDII Measure 1 for one or more refreshes in
2022, when there will be no HIS Section O data, if doing so will allow
us to consolidate changes and thus operate more efficiently.
d. Update on Transition From Hospice Compare to Care Compare and
Provider Data Catalog
In September 2020, we launched Care Compare, a streamlined redesign
of eight existing CMS healthcare compare tools available on
Medicare.gov, including Hospice Compare. Care Compare provides a single
user-friendly interface that patients and family caregivers can use to
make informed
[[Page 19755]]
decisions about healthcare based on cost, quality of care, volume of
services, and other data. With just one click, patients can find
information that is easy to understand about doctors, hospitals,
nursing homes, and other health care services instead of searching
through multiple tools.
For the last six years, Medicare's Hospice Compare has served as
the cornerstone for publicizing quality care information for patients,
family caregivers, consumers, and the healthcare community. The new
website builds on the eMedicare initiative to deliver simple tools and
information to current and future Medicare beneficiaries. Drawing on
lessons learned through research and stakeholder feedback, Care Compare
includes features and functionalities that appeal to Hospice Compare
consumers. By offering an accessible and user-friendly interface and a
simple design that is optimized for mobile and tablet use, it is easier
than ever to find information that is important to patients when
shopping for healthcare. Enhancements for mobile use will give
practical benefits like accessing the tool using a smartphone that can
initiate phone calls to providers simply by clicking on the provider's
phone number.
In conjunction with the Care Compare launch, we have made
additional improvements to other CMS data tools, to help Medicare
beneficiaries compare costs. Specifically, the Provider Data Catalog
(PDC) better serves innovators and stakeholders who are interested in
detailed CMS data and use interactive and downloadable datasets like
those currently available on data.Medicare.gov. The PDC now makes
quality datasets available through an improved Application Programming
Interface (API), allowing innovators in the field to easily access and
analyze the CMS publicly-reported data and make it useful for patients.
e. Update on Additional Information on Hospices for Public Reporting
In the FY 2019 Hospice Wage Index and Payment Rate Update and
Hospice Quality Reporting Requirements final rule (83 FR 38622), we
finalized plans to publicly post information from the Medicare Provider
Utilization and Payment Data: Hospice Public Use File (PUF) and other
publicly-available CMS data to Hospice Compare or another CMS website.
Hospice PUF data are available for CY 2014 through CY 2016. Beginning
with CY 2017 data, hospice PUF data are public as part of the Post-
Acute Care and Hospice Provider Utilization and Payment PUF (hereafter
PAC PUF). For more information, please visit the PAC PUF web page at:
https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/PAC2017. Both the
Hospice and PAC PUFs provide information on services provided to
Medicare beneficiaries by hospice providers. Specifically, they contain
information on utilization, payment (Medicare payment and standard
payment), submitted charges, primary diagnoses, sites of service, and
beneficiary demographics organized by CCN (6-digit provider
identification number) and state.
PUF data, along with clear text explaining the purpose and uses of
this information and suggesting consumers discuss this information with
their healthcare provider, first displayed in a consumer-friendly
format on Hospice Compare in May 2019. Beginning May 2021, we will
begin to display additional information from the PAC PUF on Care
Compare. This additional information includes hospices' beneficiary
characteristics such as the percentage of patients enrolled in Medicare
Advantage. In addition, consumers will see whether a hospice provided
services to Medicare Advantage enrollees or patients who have coverage
under both Medicaid and Medicare, also called dual eligible patients.
The data for these additional characteristics are pulled directly from
the PAC PUF file and provide potential hospice service patients and
family caregivers with more detail prior to selecting a hospice.
As finalized in the FY 2019 Hospice Wage Index and Payment Update
final rule (83 FR 38622), we also improved access to publicly-available
information about hospices' compliance with Hospice QRP requirements.
Specifically, we already post the annual Hospice APU Compliant List on
the HQRP Requirements and Best Practices web page. This document
displays the CCN, name, and address of every hospice that successfully
met quality reporting program requirements for the fiscal year.
Hospices are only considered compliant if they meet the standards for
HIS and CAHPS reporting, as codified in Sec. 418.312. Consumers can
now access the Hospice APU compliance file from Care Compare, enabling
them to determine if a particular hospice is compliant with CMS'
quality reporting requirements.
G. Proposal for the January 2022 HH QRP Public Reporting Display
Schedule With Fewer Than Standard Number of Quarters Due to COVID-19
Public Health Emergency Exemptions
1. Background and Statutory Authority
We include this Home Health proposal in this rule because we plan
to resume public reporting for the HH QRP with the January 2022 refresh
of Care Compare. In order to accommodate the exception of 2020 Q1 and
Q2 data, we are proposing to resume public reporting using 3 out of 4
quarters of data for the January 2022 refresh. In order to finalize
this proposal in time to release the required preview report related to
the refresh, which we release 3 months prior to any given refresh
(October 2021), we need the rule containing this proposal to finalize
by October 2021.
The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act.
Section 1895(b)(3)(B)(v)(II) of the Act requires that for 2007 and
subsequent years, each HHA submit to the Secretary in a form and
manner, and at a time, specified by the Secretary, such data that the
Secretary determines are appropriate for the measurement of health care
quality. To the extent that an HHA does not submit data in accordance
with this clause, the Secretary shall reduce the home health market
basket percentage increase applicable to the HHA for such year by 2
percentage points. As provided at section 1895(b)(3)(B)(vi) of the Act,
depending on the market basket percentage increase applicable for a
particular year, the reduction of that increase by 2 percentage points
for failure to comply with the requirements of the HH QRP and further
reduction of the increase by the productivity adjustment (except in
2018 and 2020) described in section 1886(b)(3)(B)(xi)(II) of the Act
may result in the home health market basket percentage increase being
less than 0.0 percent for a year, and may result in payment rates under
the Home Health PPS for a year being less than payment rates for the
preceding year. For more information on the policies we have adopted
for the HH QRP, we refer readers to the following rules:
CY 2007 HH PPS final rule (71 FR 65888 through 65891).
CY 2008 HH PPS final rule (72 FR 49861 through 49864).
CY 2009 HH PPS update notice (73 FR 65356).
CY 2010 HH PPS final rule (74 FR 58096 through 58098).
CY 2011 HH PPS final rule (75 FR 70400 through 70407).
CY 2012 HH PPS final rule (76 FR 68574).
[[Page 19756]]
CY 2013 HH PPS final rule (77 FR 67092).
CY 2014 HH PPS final rule (78 FR 72297).
CY 2015 HH PPS final rule (79 FR 66073 through 66074).
CY 2016 HH PPS final rule (80 FR 68690 through 68695).
CY 2017 HH PPS final rule (81 FR 76752).
CY 2018 HH PPS final rule (82 FR 51711 through 51712).
CY 2019 HH PPS final rule with comment period (83 FR
56547).
CY 2020 HH PPS final rule (84 FR 60554 through 60611).
CY 2021 HH PPS final rule (85 FR 70326 through 70328).
2. Public Display of Home Health Quality Data for the HH QRP
Section 1895(b)(3)(B)(v)(III) of the Act requires the Secretary to
establish procedures for making HH QRP data, including data submitted
under sections 1899B(c)(1) and 1899B(d)(1) of the Act, available to the
public. Such public display procedures must ensure that HHAs have the
opportunity to review the data that will be made public with respect to
each HHA prior to such data being made public. Section 1899B(g) of the
Act requires that data and information regarding PAC provider
performance on quality measures and resource use or other measures be
made publicly available beginning not later than 2 years after the
applicable specified ``application date''.
We established our HH QRP Public Display Policy in the CY 2016 HH
PPS final rule (80 FR 68709 through 68710). In that final rule, we
noted that the procedures for HHAs to review and correct their data on
a quarterly basis is performed through CASPER along with our procedure
to post the data for the public on our Care Compare website. We have
communicated our public display schedule, which supports our Public
Display Policy, on our websites whereby the quarters of data included
are announced.
3. Proposal To Modify HH QRP Public Reporting To Address CMS' Guidance
To Except Data During the COVID-19 PHE Beginning January 2022 Through
July 2024
We are proposing to modify our public display schedule to display
fewer quarters of data than what we previously finalized for certain HH
QRP measures for the January 2022 refreshes. Under authority of section
319 of the PHS Act, the Secretary declared a PHE effective as of
January 27, 2020. On March 13, 2020, the President declared a national
state of emergency under the Stafford Act, effective March 1, 2020,
allowing the Secretary to invoke section 1135(b) of the Act (42 U.S.C.
1320b-5) to waive or modify the requirements of titles XVIII, XIX, and
XXI of the Act and regulations to the extent necessary to address the
COVID-19 PHE. Many waivers and modifications were made effective as of
March 1, 2020 in accordance with the President's declaration.\57\
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\57\ Azar, A.M. (2020 March 15). Waiver or Modification of
Requirements Under Section 1135 of the Social Security Act. Public
Health Emergency. https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
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On March 27, 2020, we sent a guidance memorandum under the subject
title, ``Exceptions and Extensions for Quality Reporting Requirements
for Acute Care Hospitals, PPS-Exempt Cancer Hospitals, Inpatient
Psychiatric Facilities, Skilled Nursing Facilities, Home Health
Agencies (HHAs), Hospices, Inpatient Rehabilitation Facilities, Long-
Term Care Hospitals, Ambulatory Surgical Centers, Renal Dialysis
Facilities, and MIPS Eligible Clinicians Affected by COVID-19'' to the
MLN Connects Newsletter and Other Program-Specific Listserv
Recipients,\58\ hereafter referred to as the March 27, 2020 CMS
Guidance Memorandum. In the March 27, 2020 CMS Guidance Memo, we
granted an exception to the HH QRP reporting requirements under the HH
QRP exceptions and extension requirements for Quarter 4 (Q4) 2019
(October 1, 2019 through December 31, 2019), Q1 2020 (January 1, 2020
through March 30, 2020), and Q2 2020 (April 1, 2020 through June 30,
2020). The HH QRP exception applied to the HH QRP Outcome and
Assessment Information Set (OASIS)-based measures, claims-based
measures, and HH CAHPS Survey. We discuss the impact to the OASIS and
claims here, and discuss to the HH CAHPS further in section III.G. 4,
Update on Use of Q4 2019 HH QRP Data and Data Freeze for Refreshes in
2021. For the OASIS, the exempted quarters are based upon admission and
discharge assessments.
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\58\ (2020, March 27). Exceptions and Extensions for Quality
Reporting Requirements for Acute Care Hospitals, PPS-Exempt Cancer
Hospitals, Inpatient Psychiatric Facilities, Skilled Nursing
Facilities, Home Health Agencies, Hospices, Inpatient Rehabilitation
Facilities, Long-Term Care Hospitals, Ambulatory Surgical Centers,
Renal Dialysis Facilities, and MIPS Eligible Clinicians Affected by
COVID-19. Centers for Medicare & Medicaid Services. https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
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A subset of the HH QRP measures has been publicly displayed on Home
Health Compare (HH Compare) since 2003. Under the current HH QRP public
display policy, Home Health Compare uses 4 quarters of data to publicly
display OASIS-based measures, and 4 or more quarters of data to
publicly display claims-based measures. We use four rolling quarters of
data to publicly display Home Health Care Consumer Assessment of
Healthcare Providers and Systems (HHCAHPS) Survey measures on Care
Compare. As of September 2020, HH QRP OASIS, claims-based, and HHCAHPS
Survey measures are reported on the www.medicare.gov's Care Compare
website. As of December 2020, the data is no longer reported on the
www.medicare.gov's Home Health Compare website.
The exception granted under the March 27, 2020 CMS Guidance Memo
impacted the HH QRP public display schedule. We will resume publicly
displaying HH QRP claims-based measures in January 2022 based upon the
quarters of data specified for each of the claims-based measures. Table
30 displays the original schedule for public reporting of OASIS and
HHCAHPS Survey measures prior to the Q1 and Q2 2020 data impacted by
the COVID-19 PHE.
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During the spring and summer of 2020, we conducted testing to
inform decisions about publicly displaying HH QRP data for those
refreshes which include data from the exception period of October 1,
2019 through June 30, 2020 (hereafter ``excepted data''). The testing
helped us develop a plan for displaying HH QRP data that are as up-to-
date as possible and that also meet scientifically-acceptable standards
for publicly displaying those data. We believe that the plan allows us
to provide consumers with helpful information on the quality of home
health care, while also making the necessary adjustments to accommodate
the exception granted to HHAs. The following sections provide the
results of our testing for OASIS and claims and explain how we used the
results to inform a proposal for accommodating excepted data in public
reporting. HH CAHPS discussion is further in section III.G.4.
4. Update on Use of Q4 2019 HH QRP Data and Data Freeze for Refreshes
in 2021
In the March 27, 2020 Guidance Memorandum, we stated that we should
not include any PAC quality data that are greatly impacted by the
exception granted in the quality reporting programs. Given the timing
of the PHE onset, we determined that we would not use HH QRP OASIS,
claims, or HHCAHPS data from Q1 and Q2 of 2020 for public reporting,
and that we would assess the impact of the COVID-19 PHE on HH QRP data
from Q4 2019. In the original schedule (Table 30), the October 2020
refresh included Q4 2019 measure based on OASIS and HHCAHPS data and is
the last refresh before Q1 2020 data are included.
Before proceeding with the October 2020 refresh, we conducted
testing to ensure that publicly displaying Q4 2019 data would still
meet our standards despite granting an exception to HH QRP reporting
requirements for Q4 2019. Specifically, we compared submission rates in
Q4 2019 to average rates in other quarters to assess the extent to
which HHAs had taken advantage of the exemption, and thus the extent to
which data and measure scores might be affected. We observed that the
quality data submission rate for Q4 2019 was in fact 0.4 percent higher
than the previous calendar year (Q4 2018). We note that Q4 2019 ended
before the onset of the COVID-19 pandemic in the U.S. Thus, we
proceeded with including Q4 2019 data in measure calculations for the
October 2020 refresh.
Because we excepted HHAs from the HH QRP reporting requirements for
Q1 and Q2 2020, we did not use OASIS, claims, or HHCAHPS data from
these quarters. All refreshes, during which we decided to hold this
data constant, included more than 2 quarters of data that were affected
by the CMS-issued COVID reporting exceptions, thus we did not have an
adequate amount of data to reliably calculate and publicly display
provider measures scores.
Consequently, we determined to freeze the data displayed, that is,
holding data constant after the October 2020 refresh without
subsequently updating the data through October 2021. We communicated
this in a Public Reporting Tip Sheet, which is located at: https://www.cms.gov/files/document/hhqrp-pr-tip-sheet081320final-cx-508.pdf.
5. Proposal To Use the COVID-19 PHE Affected Reporting (CAR) Scenario
To Publicly Display Certain HH QRP Measures (Beginning in January 2022
through July 2024) Due to the COVID-19 PHE
We are also proposing to use the CAR scenario for refreshes for
January 2022 for OASIS and for refreshes from January 2022 through July
2024 for some claims-based measures. There are several forthcoming HH
QRP refreshes
[[Page 19759]]
for which the original public reporting schedule included other
quarters from the quality data submission exception. These refreshes
for claims-based measures, OASIS-based measures, and for HHCAHPS Survey
measures are outlined above (Table 30).
Because October 2020 refresh data will become increasingly out-of-
date and thus less useful for the public, we analyzed whether it would
be possible to use fewer quarters of data for one or more refreshes and
thus reduce the number of refreshes that continue to display October
2020 data. Using fewer quarters of more up-to-date data requires that:
(1) A sufficient percentage of HHAs would still likely have enough
OASIS data to report quality measures (reportability); and (2) using
fewer quarters of data to calculate measures would likely produce
similar measure scores for HHAs, and thus not unfairly represent the
quality of care HHAs provided during the period reported in a given
refresh (reliability).
To assess these criteria, we conducted reportability and
reliability analysis excluding the COVID-19 affected quarters of data
in a refresh instead of the standard number of quarters of data for
reporting for each HH QRP measure to model the impact of not using Q1
or Q2 2020. Specifically, we used historical data to calculate HH
quality measures under two scenarios:
Standard Public Reporting (SPR) Scenario: We used HH QRP
data from CY 2017 through 2019 to build the standard reported measures,
to represent as a proxy CY 2020 public reporting in the absence of the
temporary exemptions from the submission of OASIS quality data, as the
basis for comparing simulated alternatives. This entails using 4
quarters of CY 2019 HH QRP data to model the OASIS based measures that
are normally calculated using 4 quarters of data. This also entailed
using 4 quarters of HH QRP data from CY 2019 for the all-cause
hospitalization and emergency department use claims-based measures, 8
quarters of HH QRP data from CY2018 and CY2019 for Medicare spending
per beneficiary (MSPB) and discharge to community (DTC) claims-based
measures; and or 12 quarters from January 2017 to December 2019 for the
potentially preventable readmission claims-based measure.
COVID-19 Affected Reporting (CAR) Scenario: We calculated
OASIS-based measures using 3 quarters of HH QRP CY 2019 data to
simulate using only Q3 2020, Q4 2020, and Q1 2021 data for public
reporting. We calculated claims-based measures using HH QRP CY 2017 to
2019 data, to simulate using the most recent data while excluding the
same quarters (Q1 and Q2) that are relevant from the PHE exception. We
used 3 quarters of HH QRP data from CY 2019 for the all-cause
hospitalization and emergency department use claims-based measures and
6 quarters of data from HH QRP CY 2018 and CY 2019 were used for both
the Medicare spending per beneficiary and discharge to community
claims-based measures. We used 10 quarters of HH QRP data from CY 2017
to 2019 to calculate the CAR scenario for the potentially preventable
readmissions claims-based measure. For both claims and OASIS-based
measures, the quarters used in our analysis were the most recently
available data that exclude the same quarters (Q1 and Q2) as that are
relevant from the PHE exception, and thus take seasonality into
consideration.
The OASIS-based measures are based on the start of care and
calculated using admission dates. Therefore, under the CAR scenario we
excluded data for OASIS-based measures for HHA patient stays with
admission dates in Q1 and Q2 2019. To assess performance in these
scenarios, we calculated the reportability as the percent of HHAs
meeting the 20-case minimum for public reporting (the public reporting
threshold, or ``PRT''). We evaluated measure reliability using the
Pearson and Spearman correlation coefficients, which assess the
alignment of HHs measure scores between scenarios. To calculate the
reliability results, we restricted the HHAs included in the SPR
Scenario to those included in the CAR Scenario.
Testing results showed that using the CAR scenario would achieve
scientifically acceptable quality measure scores for the HH QRP. As
displayed in Table 31, the percentage of HHAs that met the public
display threshold for the OASIS-based measure decreases by 5.5
percentage points or less for all but one QM, the Influenza
Immunization for the Current Flu Season in the CAR scenario versus SPR
scenario. CMS has traditionally used a reportability threshold of 70
percent, meaning at least 70 percent of HHAs are able to report at
least 20 episodes for a given measure, as the standard to determine
whether a measure should be publicly reported. By this standard, we
consider a decrease of 5.5 percentage points or less scientifically
acceptable. The change in reportability for the Influenza Immunization
for the Current Flu Season measure is related to the seasonality of
this measure, which includes cases that occur during the flu season
only.
Under the CAR scenario, the January 2022 refresh data would cover
Q3 and Q4 of 2020 and Q1 of 2021, which occur during the flu season.
This simulation included Q2 through Q4 of 2019, which crosses the flu
season. Thus, the reportability of the actual data used is likely to be
better than this simulation. Therefore, in general, using CAR scenario
for the OASIS and claims-based measures would achieve acceptable
reportability for the HH QRP measures. Testing also yielded correlation
coefficients above 0.85, indicating a high degree of agreement between
HH measure scores when using the CAR scenario or the SPR scenario.
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We are proposing to use the CAR scenario for the last of the
refreshes affecting OASIS-based measures, which will occur in January
2022. We are also proposing to use the CAR scenario for refreshes from
January 2022 through July 2024 for some claims-based measures.
Our proposal of the CAR scenario for the January 2022 refresh would
allow us to begin displaying recent data in January 2022, rather than
continue displaying October 2020 data (Q1 2019
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through Q4 2019). We believe that updating the data in January 2022 by
more than a year relative to the October 2020 freeze data can assist
the public by providing more relevant quality data and allow CMS to
display more recent HHA performance. Similarly, using fewer than
standard numbers of quarters for claims-based measures that typically
use eight or twelve months of data for reporting between January 2022
and July 2024 will allow us to begin providing more relevant data
sooner. Our testing results indicate we can achieve these positive
impacts while maintaining high standards for reportability and
reliability. Table 32 and Table 33 summarize the comparison between the
original schedule for public reporting with the revised schedule (that
is, frozen data) and also with the proposed public display schedule
under the CAR scenario (that is, using 3 quarters in the January 2022
refresh), for OASIS- and claims-based measures respectively.
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We are soliciting public comments on the proposal to use the CAR
scenario to publicly report HH OASIS in January 2022 and claims-based
measures beginning with the January 2022 through July 2024 refreshes.
6. Update to the Public Display of HHCAHPS Measures Due to the COVID-19
PHE Exception
Since April 2012, we have publicly displayed four quarters of
HHCAHPS data every quarter, in the months of January, April, July, and
October. The COVID-19 PHE Exception applied to Q1 and Q2 of 2020. Those
excepted quarters cannot be publicly displayed and resulted in the
freezing of the public display using Q1 2019 through Q4 2019 data for
the refreshes that would have occurred from October 2020 through
October 2021, as shown in Table 34. Beginning with January 2022, we
will resume reporting four quarters of HHCAHPS data. The data for the
January 2022 refresh are Q3 2020 through Q2 2021. These are the same
quarters that would have been publicly
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displayed despite the COVID-19 PHE. Table 34 summarizes this
discussion.
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IV. Requests for Information
A. Fast Healthcare Interoperability Resources (FHIR) in Support of
Digital Quality Measurement in Post-Acute Care Quality Reporting
Programs--Request for Information
1. Background
A goal of the HQRP is to improve the quality of health care for
beneficiaries through measurement, transparency, and public reporting
of data. The HQRP contributes to improvements in health care, enhancing
patient outcomes, and informing consumer choice. In October 2017, we
launched the Meaningful Measures Framework. This framework captures our
vision to address health care quality priorities and gaps, including
emphasizing digital quality measurement (dQM), reducing measurement
burden, and promoting patient perspectives, while also focusing on
modernization and innovation. The scope of the Meaningful Measures
Framework has evolved to Meaningful Measure 2.0 to accommodate the
changes in the health care environment, initially focusing on measure
and burden reduction to include the promotion of innovation and
modernization of all aspects of quality.\59\ There is a need to
streamline our approach to data collection, calculation, and reporting
to fully leverage clinical and patient-centered information for
measurement, improvement, and learning.
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\59\ Meaningful Measures 2.0: Moving from Measure Reduction to
Modernization. Available at: https://www.cms.gov/meaningful-measures-20-moving-measure-reduction-modernization.
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In alignment with the Meaningful Measure 2.0, we are seeking
feedback on our future plans to define digital quality measures for the
HQRP. We also are seeking feedback on the potential use of Fast
Healthcare Interoperable Resources (FHIR) for dQMs within the HQRP
aligning where possible with other quality programs. FHIR is an open
source standards framework (in both commercial and government settings)
created by Health Level Seven International (HL7[supreg]) that
establishes a common language and process for all health information
technology.
2. Definition of Digital Quality Measures
We are considering adopting a standardized definition of Digital
Quality Measures (dQMs) in alignment across QRPs. We are considering in
the future to propose the adoption within the HQRP the following
definition: Digital Quality Measures (dQMs) are quality measures that
use one or more sources of health information that are captured and can
be transmitted electronically via interoperable
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systems.\60\ A dQM includes software that processes digital data to
produce a measure score or measure scores. Data sources for dQMs may
include administrative systems, electronically submitted clinical
assessment data, case management systems, electronic health records
(EHRs), instruments (for example, medical devices and wearable
devices), patient portals or applications (for example, for collection
of patient-generated health data), health information exchanges (HIEs)
or registries, and other sources. As an example, the quality measures
calculated from patient assessment data submitted electronically to CMS
would be considered digital quality measures.
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\60\ Definition taken from the CMS Quality Conference 2021.
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3. Use of FHIR for Future dQMs in HQRP
Over the past two years in other programs, we have focused on
opportunities to streamline and modernize quality data collection and
reporting processes, such as exploring HL7[supreg] FHIR[supreg] (http://hl7.org/fhir) for quality reporting programs. One of the first areas
CMS has identified relative to improving our digital strategy is
through the use of FHIR-based standards to exchange clinical
information through application programming interfaces (APIs), allowing
clinicians to digitally submit quality information one time that can
then be used in many ways. We believe that in the future proposing such
a standard within the HQRP could potentially enable collaboration and
information sharing, which is essential for delivering high-quality
care and better outcomes at a lower cost.
We are currently evaluating the use of FHIR based APIs to access
assessment data collected and maintained through the Quality
Improvement and Evaluation System (QIES) and internet QIES (iQIES)
health information systems and are working with healthcare standards
organizations to assure that their evolving standards fully support our
assessment instrument content. Further, as more hospice providers are
adopting EHRs including hospices, we are evaluating using the FHIR
interfaces for accessing patient data (including standard assessments)
directly from hospice EHRs. Accessing data in this manner could also
enable the exchange of data for purposes beyond data reporting to CMS,
such as care coordination further increasing the value of EHR
investments across the healthcare continuum. Once providers map their
EHR data to a FHIR API in standard FHIR formats it could be possible to
send and receive the data needed for measures and other uses from their
EHRs through FHIR APIs.
4. Future Alignment of Measures Across Reporting Programs, Federal and
State Agencies, and the Private Sector
We are committed to using policy levers and working with
stakeholders to achieve interoperable data exchange and to transition
to full digital quality measurement in our quality programs. We are
considering the future potential development and staged implementation
of a cohesive portfolio of dQMs across our regulated programs,
including HQRP, agencies, and private payers. This cohesive portfolio
would require, where possible, alignment of: (1) Measure concepts and
specifications including narrative statements, measure logic, and value
sets, and (2) the individual data elements used to build these measure
specifications and calculate the measures. Further, the required data
elements would be limited to standardized, interoperable elements to
the fullest extent possible; hence, part of the alignment strategy will
be the consideration and advancement of data standards and
implementation guides for key data elements. We would coordinate
closely with quality measure developers, Federal and state agencies,
and private payers to develop and to maintain a cohesive dQM portfolio
that meets our programmatic requirements and that fully aligns across
Federal and state agencies and payers to the extent possible.
We intend this coordination to be ongoing and allow for continuous
refinement to ensure quality measures remain aligned with evolving
healthcare practices and priorities (for example, patient reported
outcomes (PROs), disparities, care coordination), and track with the
transformation of data collection. This includes conformance with
standards and health IT module updates, future adoption of technologies
incorporated within the ONC Health IT Certification Program and may
also include standards adopted by ONC (for example, standards-based
APIs). The coordination would build on the principles outlined in HHS'
Nation Health Quality Roadmap.\61\
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\61\ Department of Health and Human Services. National Health
Quality Roadmap. May 15, 2020. Available at: https://www.hhs.gov/sites/default/files/national-health-quality-roadmap.pdf.
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It would focus on the quality domains of safety, timeliness,
efficiency, effectiveness, equitability, and patient-centeredness. It
would leverage several existing Federal and public-private efforts
including our Meaningful Measures 2.0 Framework; the Federal Electronic
Health Record Modernization (DoD/VA); the Core Quality Measure
Collaborative, which convenes stakeholders from America's Health
Insurance Plans (AHIP), CMS, NQF, provider organizations, private
payers, and consumers and develops consensus on quality measures for
provider specialties; and the NQF-convened Measure Applications
Partnership (MAP), which recommends measures for use in public payment
and reporting programs. We would coordinate with HL7's ongoing work to
advance FHIR resources in critical areas to support patient care and
measurement such as social determinants of health. Through this
coordination, we would identify which existing measures could be used
or evolved to be used as dQMs, in recognition of current healthcare
practice and priorities.
This multi-stakeholder, joint Federal, state, and industry effort,
made possible and enabled by the pending advances towards
interoperability, would yield a significantly improved quality
measurement enterprise. The success of the dQM portfolio would be
enhanced by the degree to which the measures achieve our programmatic
requirements as well as the requirements of other agencies and payers.
5. Solicitation of Comments
We seek input on the following steps that would enable
transformation of CMS' quality measurement enterprise to be fully
digital:
a. What EHR/IT systems do you use and do you participate in a
health information exchange (HIE)?
b. How do you currently share information with other providers and
are there specific industry best practices for integrating SDOH
screening into EHR's?
c. What ways could we incentivize or reward innovative uses of
health information technology (IT) that could reduce burden for post-
acute care settings, including but not limited to hospices?
d. What additional resources or tools would post-acute care
settings, including but not limited to hospices and health IT vendors
find helpful to support testing, implementation, collection, and
reporting of all measures using FHIR standards via secure APIs to
reinforce the sharing of patient health information between care
settings?
e. Would vendors, including those that service post-acute care
settings, including but not limited to hospices, be interested in or
willing to participate in pilots or models of alternative approaches to
quality measurement that
[[Page 19766]]
would align standards for quality measure data collection across care
settings to improve care coordination, such as sharing patient data via
secure FHIR API as the basis for calculating and reporting digital
measures?
f. What could be the potential use of FHIR dQMs that could be
adopted across all QRPs?
We plan to continue working with other agencies and stakeholders to
coordinate and to inform our transformation to dQMs leveraging health
IT standards. While we will not be responding to specific comments
submitted in response to this Request for Information in the FY 2022
Hospice final rule, we will actively consider all input as we develop
future regulatory proposals or future sub-regulatory policy guidance.
Any updates to specific program requirements related to quality
measurement and reporting provisions would be addressed through
separate and future notice- and-comment rulemaking, as necessary.
B. Closing the Health Equity Gap in Post-Acute Care Quality Reporting
Programs--Request for Information
1. Background
Significant and persistent inequities in health outcomes exist in
the United States. In recognition of persistent health disparities and
the importance of closing the health equity gap, we request information
on expanding several related CMS programs to make reporting of health
disparities based on social risk factors and race and ethnicity more
comprehensive and actionable for providers and patients. Belonging to a
racial or ethnic minority group; living with a disability; being a
member of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+)
community; or being near or below the poverty level, is often
associated with worse health
outcomes.62 63 64 65 66 67 68 69 Such disparities in health
outcomes are the result of number of factors, but importantly for CMS
programs, although not the sole determinant, poor access and provision
of lower quality health care contribute to health disparities. For
instance, numerous studies have shown that among Medicare
beneficiaries, racial and ethnic minority individuals often receive
lower quality of care, report lower experiences of care, and experience
more frequent hospital readmissions and operative
complications.70 71 72 73 74 75 Readmission rates for common
conditions in the Hospital Readmissions Reduction Program are higher
for black Medicare beneficiaries and higher for Hispanic Medicare
beneficiaries with Congestive Heart Failure and Acute Myocardial
Infarction.76 77 78 79 80 Studies have also shown that
African Americans are significantly more likely than white Americans to
die prematurely from heart disease and stroke.\81\ The COVID-19
pandemic has further illustrated many of these longstanding health
inequities with higher rates of infection, hospitalization, and
mortality among black, Latino, and Indigenous and Native American
persons relative to white persons.82 83 As noted by the
Centers for Disease Control ``long-standing systemic health and social
inequities have put many people from racial and ethnic minority groups
at increased risk of getting sick and dying from COVID-19''.\84\ One
important strategy for addressing these important inequities is by
improving data collection to allow for better measurement and reporting
on equity across our programs and policies.
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\62\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA. 2011;
305(7):675-681.
\63\ Lindenauer PK, Lagu T, Rothberg MB, et al. Income
Inequality and 30 Day Outcomes After Acute Myocardial Infarction,
Heart Failure, and Pneumonia: Retrospective Cohort Study. British
Medical Journal. 2013; 346.
\64\ Trivedi AN, Nsa W, Hausmann LRM, et al. Quality and Equity
of Care in U.S. Hospitals. New England Journal of Medicine. 2014;
371(24):2298-2308.
\65\ Polyakova, M., et al. Racial Disparities In Excess All-
Cause Mortality During The Early COVID-19 Pandemic Varied
Substantially Across States. Health Affairs. 2021; 40(2): 307-316.
\66\ Rural Health Research Gateway. Rural Communities: Age,
Income, and Health Status. Rural Health Research Recap. November
2018.
\67\ https://www.minorityhealth.hhs.gov/assets/PDF/Update_HHS_Disparities_Dept-FY2020.pdf.
\68\ www.cdc.gov/mmwr/volumes/70/wr/mm7005a1.htm.
\69\ Poteat TC, Reisner SL, Miller M, Wirtz AL. COVID-19
Vulnerability of Transgender Women With and Without HIV Infection in
the Eastern and Southern U.S. Preprint. medRxiv.
2020;2020.07.21.20159327. Published 2020 Jul 24. doi:10.1101/
2020.07.21.20159327.
\70\ Martino, SC, Elliott, MN, Dembosky, JW, Hambarsoomian, K,
Burkhart, Q, Klein, DJ, Gildner, J, and Haviland, AM. Racial,
Ethnic, and Gender Disparities in Health Care in Medicare Advantage.
Baltimore, MD: CMS Office of Minority Health. 2020.
\71\ Guide to Reducing Disparities in Readmissions. CMS Office
of Minority Health. Revised August 2018. Available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
\72\ Singh JA, Lu X, Rosenthal GE, Ibrahim S, Cram P. Racial
disparities in knee and hip total joint arthroplasty: An 18-year
analysis of national Medicare data. Ann Rheum Dis. 2014
Dec;73(12):2107-15.
\73\ Rivera-Hernandez M, Rahman M, Mor V, Trivedi AN. Racial
Disparities in Readmission Rates among Patients Discharged to
Skilled Nursing Facilities. J Am Geriatr Soc. 2019 Aug;67(8):1672-
1679.
\74\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\75\ Tsai TC, Orav EJ, Joynt KE. Disparities in surgical 30-day
readmission rates for Medicare beneficiaries by race and site of
care. Ann Surg. Jun 2014;259(6):1086-1090.
\76\ Rodriguez F, Joynt KE, Lopez L, Saldana F, Jha AK.
Readmission rates for Hispanic Medicare beneficiaries with heart
failure and acute myocardial infarction. Am Heart J. Aug
2011;162(2):254-261 e253.
\77\ Centers for Medicare and Medicaid Services. Medicare
Hospital Quality Chartbook: Performance Report on Outcome Measures;
2014.
\78\ Guide to Reducing Disparities in Readmissions. CMS Office
of Minority Health. Revised August 2018. Available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
\79\ Prieto-Centurion V, Gussin HA, Rolle AJ, Krishnan JA.
Chronic obstructive pulmonary disease readmissions at minority-
serving institutions. Ann Am Thorac Soc. Dec 2013;10(6):680-684.
\80\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\81\ HHS. Heart disease and African Americans. (March 29, 2021).
https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
\82\ https://www.cms.gov/files/document/medicare-covid-19-data-snapshot-fact-sheet.pdf.
\83\ Ochieng N, Cubanski J, Neuman T, Artiga S, and Damico A.
Racial and Ethnic Health Inequities and Medicare. Kaiser Family
Foundation. Februray 2021. Available at: https://www.kff.org/medicare/report/racial-and-ethnic-health-inequities-and-medicare/.
\84\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html.
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We are committed to achieving equity in health care outcomes for
our beneficiaries by supporting providers in quality improvement
activities to reduce health inequities, enabling beneficiaries to make
more informed decisions, and promoting provider accountability for
health care disparities.85 86 For the purposes of this rule,
we are using a definition of equity established in Executive Order
13985, as ``the consistent and systematic fair, just, and impartial
treatment of all individuals, including individuals who belong to
underserved communities that have been denied such treatment, such as
Black, Latino, and Indigenous and Native American persons, Asian
Americans and Pacific Islanders and other persons of color; members of
religious minorities; lesbian, gay, bisexual, transgender, and queer
(LGBTQ+) persons; persons with disabilities; persons who live in rural
areas; and persons otherwise adversely
[[Page 19767]]
affected by persistent poverty or inequality.'' \87\ We note that this
definition was recently established by the current administration, and
provides a useful, common definition for equity across different areas
of government, although numerous other definitions of equity exist.
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\85\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
\86\ Report to Congress: Improving Medicare Post-Acute Care
Transformation (IMPACT) Act of 2014 Strategic Plan for Accessing
Race and Ethnicity Data. January 5, 2017. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Research-Reports-2017-Report-to-Congress-IMPACT-ACT-of-2014.pdf.
\87\ https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-Federal-government.
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Our ongoing commitment to closing the equity gap in CMS quality
programs is demonstrated by a portfolio of programs aimed at making
information on the quality of health care providers and services,
including disparities, more transparent to consumers and providers. The
CMS Equity Plan for Improving Quality in Medicare aims to support
Quality Improvement Networks and Quality Improvement Organizations
(QIN-QIOs); Federal, state, local, and tribal organizations; providers;
researchers; policymakers; beneficiaries and their families; and other
stakeholders in activities to achieve health equity. The CMS Equity
Plan includes three core elements: (1) Increasing understanding and
awareness of disparities; (2) developing and disseminating solutions to
achieve health equity; and (3) implementing sustainable actions to
achieve health equity.\88\ The CMS Quality Strategy and Meaningful
Measures Framework \89\ include elimination of racial and ethnic
disparities as a fundamental principle. Our ongoing commitment to
closing the health equity gap in the HQRP is demonstrated by the
sharing of information from the Medicare PAC PUF on Care Compare and
seeking to adopt through future rulemaking aspects of the standardized
patient assessment data elements (SPADEs) that apply to hospice which
include several social determinants of health (SDOH).
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\88\ Centers for Medicare & Medicaid Services Office of Minority
Health. The CMS Equity Plan for Improving Quality in Medicare.
https://www.cms.gov/About-CMS/Agency-Information/OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_090615.pdf.
\89\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.
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We continue to work with Federal and private partners to better
collect and leverage data on social risk to improve our understanding
of how these factors can be better measured in order to close the
health equity gap. Among other things, we have developed an Inventory
of Resources for Standardized Demographic and Language Data Collection
\90\ and supported collection of specialized International
Classification of Disease, 10th Edition, Clinical Modification (ICD-10-
CM) codes for describing the socioeconomic, cultural, and environmental
determinants of health. We continue to work to improve our
understanding of this important issue and to identify policy solutions
that achieve the goals of attaining health equity for all patients.
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\90\ Centers for Medicare and Medicaid Services. Building an
Organizational Response to Health Disparities Inventory of Resources
for Standardized Demographic and Language Data Collection. 2020.
https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Collection-Resources.pdf.
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2. Solicitation of Public Comment
While hospice is not included in the Improving Medicare Post-Acute
Care Transformation (IMPACT) Act of 2014 (Pub. L. 113-185), we look at
measures adopted based on that Act, like SPADES and if aspects apply to
hospice then we would consider including it in the HQRP. This helps
with continuity of care since patients may transition from different
PAC settings to hospice and it would address a gap in hospice care. We
are seeking comment on the possibility of expanding measure
development, and adding aspects of SPADEs that could apply to hospice
and address gaps in health equity in the HQRP. Any potential health
equity data collection or measure reporting within a CMS program that
might result from public comments received in response to this
solicitation would be addressed through a separate notice- and-comment
rulemaking in the future.
Specifically, we are inviting public comment on the following:
Recommendations for quality measures, or measurement
domains that address health equity, for use in the HQRP.
Suggested parts of SDOH SPADEs adoption that could apply
to hospice in alignment with national data collection and interoperable
exchange standards. This could include collecting information on
certain SDOH, including race, ethnicity, preferred language,
interpreter services, health literacy, transportation and social
isolation. CMS is seeking guidance on any additional items, including
SPADEs that could be used to assess health equity in the care of
hospice patients, for use in the HQRP.
Ways CMS can promote health equity in outcomes among
hospice patients. We are also interested in feedback regarding whether
including facility-level quality measure results stratified by social
risk factors and social determinants of health (for example, dual
eligibility for Medicare and Medicaid, race) in confidential feedback
reports could allow facilities to identify gaps in the quality of care
they provide. (For example, methods similar or analogous to the CMS
Disparity Methods \91\ which provide hospital-level confidential
results stratified by dual eligibility for condition-specific
readmission measures currently included in the Hospital Readmission
Reduction Program (84 FR 42496 through 42500)).
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\91\ https://qualitynet.cms.gov/inpatient/measures/disparity-methods/methodology.
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Methods that commenters or their organizations use in
employing data to reduce disparities and improve patient outcomes,
including the source(s) of data used, as appropriate.
Given the importance of structured data and health IT
standards for the capture, use, and exchange of relevant health data
for improving health equity, the existing challenges providers'
encounter for effective capture, use, and exchange of health
information, such as data on race, ethnicity, and other social
determinants of health, to support care delivery and decision making.
While we will not be responding to specific comments submitted in
response to this Request for Information in the FY 2022 Hospice Wage
Index final rule, we intend to use this input to inform future policy
development. We look forward to receiving feedback on these topics, and
note for readers that responses to the RFI will not directly impact
payment decisions. We also note our intention for an additional RFI or
rulemaking on this topic in the future. We look forward to receiving
feedback on these topics, and note for readers that responses to the
RFI should focus on how they could be applied to the quality reporting
program requirements.
V. Advancing Health Information Exchange
The Department of Health and Human Services (HHS) has a number of
initiatives designed to encourage and support the adoption of
interoperable health information technology and to promote nationwide
health information exchange to improve health care and patient access
to their health information. To further interoperability in post-acute
care settings, the Centers for Medicare & Medicaid Services (CMS) and
the Office of the National Coordinator for Health Information
Technology (ONC) participate in the Post-Acute Care Interoperability
Workgroup (PACIO) (https://pacioproject.org/) to facilitate
collaboration with industry stakeholders to develop Fast Healthcare
Interoperability Resources (FHIR)
[[Page 19768]]
standards. These standards could support the exchange and reuse of
patient assessment data derived from the minimum data set (MDS),
inpatient rehabilitation facility patient assessment instrument (IRF-
PAI), long term care hospital continuity assessment record and
evaluation (LCDS), outcome and assessment information set (OASIS), and
other sources, including HOPE if implemented in HQRP through future
rulemaking. The PACIO Project has focused on FHIR implementation guides
for functional status, cognitive status and new use cases on advance
directives and speech, and language pathology. We encourage PAC
provider and health IT vendor participation as these efforts advance.
The CMS Data Element Library (DEL) continues to be updated and
serves as the authoritative resource for PAC assessment data elements
and their associated mappings to health IT standards such as Logical
Observation Identifiers Names and Codes and Systematized Nomenclature
of Medicine. The DEL furthers CMS' goal of data standardization and
interoperability. These interoperable data elements can reduce provider
burden by allowing the use and exchange of healthcare data; supporting
provider exchange of electronic health information for care
coordination, person-centered care; and supporting real-time, data
driven, clinical decision making. Standards in the Data Element Library
(https://del.cms.gov/DELWeb/pubHome) can be referenced on the CMS
website and in the ONC Interoperability Standards Advisory (ISA). The
2021 ISA is available at https://www.healthit.gov/isa.
The 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted
December 13, 2016) requires HHS to take new steps to enable the
electronic sharing of health information ensuring interoperability for
providers and settings across the care continuum. The Cures Act
includes a trusted exchange framework and common agreement (TEFCA)
provision \92\ that will enable the nationwide exchange of electronic
health information across health information networks and provide an
important way to enable bi-directional health information exchange in
the future. For more information on current developments related to
TEFCA, we refer readers to https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement and
https://rce.sequoiaproject.org/.
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\92\ ONC, Draft 2 Trusted Exchange Framework and Common
Agreement, https://www.healthit.gov/sites/default/files/page/2019-04/FINALTEFCAQTF41719508version.pdf.
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On May 1, 2020, ONC published a final rule in the Federal Register
entitled ``21st Century Cures Act: Interoperability, Information
Blocking, and the ONC Health IT Certification Program'' (85 FR 25642)
that established policies related to information blocking as authorized
under section 4004 of the 21st Century Cures Act. Information blocking
is generally defined as a practice by a health IT developer of
certified health IT, health information network, health information
exchange, or health care provider that, except as required by law or
specified by the Secretary of HHS as a reasonable and necessary
activity, is likely to interfere with access, exchange, or use of
electronic health information. The definition of information blocking
includes a knowledge standard, which is different for health care
providers than for health IT developers of certified health IT and
health information networks or health information exchanges. A
healthcare provider must know that the practice is unreasonable as well
as likely to interfere with access, exchange, or use of electronic
health information. To deter information blocking, health IT developers
of certified health IT, health information networks and health
information exchanges whom the HHS Inspector General determines,
following an investigation, have committed information blocking, are
subject to civil monetary penalties of up to $1 million per violation.
Appropriate disincentives for health care providers are expected to be
established by the Secretary through future rulemaking. Stakeholders
can learn more about information blocking at https://www.healthit.gov/curesrule/final-rule-policy/information-blocking. ONC has posted
information resources including fact sheets (https://www.healthit.gov/curesrule/resources/fact-sheets), frequently asked questions (https://www.healthit.gov/curesrule/resources/information-blocking-faqs), and
recorded webinars (https://www.healthit.gov/curesrule/resources/webinars).
We invite providers to learn more about these important
developments and how they could affect hospices.
VI. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this rule that contain information collection
requirements.
A. ICRs Regarding Hospice QRP
The HQRP proposals would not change provider burden or costs.
For the proposal to remove the 7 HIS measures from the
HQRP, we do not propose any changes to the requirement to submit the
HIS admission assessment since we continue to collect the data for
these 7 HIS measures in order to calculate the more broadly applicable
NQF # 3235, the Hospice and Palliative Care Composite Process Measure--
HIS-Comprehensive Assessment Measure at Admission.
The proposal to add the HCI also would not change provider
burden or costs since it is a claims-based measure that CMS calculates
from the Medicare claims data.
Likewise, the proposal to publicly report the claims-based
HVLDL quality measure would not result in reduced provider burden and
related costs. The reduction in provider burden and costs occurred when
we replaced the HIS-based HVWDII quality measure via the HIS-PRA
package that OMB approved on February 16, 2021 (OMB Control Number:
0938-1153, CMS-10390).
Finally, the Home Health Rider proposal would not change
provider burden or costs since it only affects the number of quarters
used in the calculation of certain claims-based measures for the public
display for certain refresh cycles.
B. ICRs Regarding Hospice CoPs
We are proposing to revise the provisions at Sec. 418.76(c)(1)
that requires the hospice aide to be evaluated by observing an aide's
performance of the task with a patient. This proposed revision is
subject to the PRA; however, the information collection burden
associated with the existing requirements at Sec. 418.76(c)(1) are
[[Page 19769]]
accounted for under the information collection request currently
approved OMB control number 0938-1067. The proposed revision's addition
of the use of a ``pseudo patient'' allow for greater flexibility and
may minimally reduce burden on the hospice. We request public comment
on our determination that the time and effort necessary to comply with
implementing the use of the pseudo-patient for hospice aide training at
Sec. 418.76(c)(1), may reduce burden on the provider.
We are also proposing to revise the provisions at Sec.
418.76(h)(1)(iii) to state that if an area of concern is verified by
the hospice during the on-site visit, then the hospice must conduct,
and the hospice aide must complete, a competency evaluation related to
the deficient and related skill(s) in accordance with Sec. 418.76(c).
We believe this could increase the speed with which hospices perform
competency testing and could allow new aides to begin serving patients
more quickly as these proposed changes will allow the hospice to focus
on specific aide skills when a skill deficiency is assessed. In
accordance with the implementing regulations of the PRA at 5 CFR
1320.3(b)(2), we believe that both the existing requirements and the
proposed revisions to the requirements at Sec. 418.76(h) are exempt
from the PRA. We believe competency evaluations are a usual and
customary business practice and we state as such in the information
collection request associated with the Hospice Conditions of
Participation (0938-1067). Therefore, we are not proposing to seek PRA
approval for any information collection or recordkeeping activities
that may be conducted in connection with the proposed revisions to
Sec. 418.76(h), but we request public comment on our determination
that the time and effort necessary to comply with these evaluation
requirements is usual and customary, and would be incurred by hospice
staff even absent this regulatory requirement.
C. Submission of PRA-Related Comments
We have submitted a copy of this proposed rule to OMB for its
review of the rule's information collection and recordkeeping
requirements. The requirements are not effective until they have been
approved by OMB.
We invite public comments on these information collection
requirements. If you wish to comment, please identify the rule (CMS-
1754-P) and, where applicable, the preamble section, and the ICR
section. See this rule's DATES and ADDRESSES sections for the comment
due date and for additional instructions and OMB control number 0938-
1153 (CMS-10390) or OMB control number 0938-1067 (CMS-10277).
VII. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
VIII. Regulatory Impact Analysis
A. Statement of Need
This proposed rule meets the requirements of our regulations at
Sec. 418.306(c) and (d), which require annual issuance, in the Federal
Register, of the hospice wage index based on the most current available
CMS hospital wage data, including any changes to the definitions of
CBSAs or previously used MSAs, as well as any changes to the
methodology for determining the per diem payment rates. This proposed
rule would also update payment rates for each of the categories of
hospice care, described in Sec. 418.302(b), for FY 2022 as required
under section 1814(i)(1)(C)(ii)(VII) of the Act. The payment rate
updates are subject to changes in economy-wide productivity as
specified in section 1886(b)(3)(B)(xi)(II) of the Act.
B. Overall Impacts
We estimate that the aggregate impact of the payment provisions in
this proposed rule would result in an estimated increase of $530
million in payments to hospices, resulting from the hospice payment
update percentage of 2.3 percent for FY 2022. The impact analysis of
this proposed rule represents the projected effects of the changes in
hospice payments from FY 2021 to FY 2022. Using the most recent
complete data available at the time of rulemaking, in this case FY 2020
hospice claims data as of January 15, 2021, we apply the current FY
2021 wage index with the current labor shares. Using the same FY 2020
data, we apply the FY 2022 wage index and the current labor share
values to simulate FY 2022 payments. We then apply a budget neutrality
adjustment so that the aggregate simulated payments do not increase or
decrease due to changes in the wage index. Then, using the same FY 2020
data, we apply the FY 2022 wage index and the current labor share
values to simulate FY 2022 payments and compare simulated payments
using the FY 2022 wage index and the proposed revised labor shares. We
then apply a budget neutrality adjustment so that the aggregate
simulated payments do not increase or decrease due to changes in the
labor share values.
Certain events may limit the scope or accuracy of our impact
analysis, because such an analysis is susceptible to forecasting errors
due to other changes in the forecasted impact time period. The nature
of the Medicare program is such that the changes may interact, and the
complexity of the interaction of these changes could make it difficult
to predict accurately the full scope of the impact upon hospices.
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with
[[Page 19770]]
economically significant effects ($100 million or more in any 1 year).
We estimate that this rulemaking is ``economically significant'' as
measured by the $100 million threshold, and hence also a major rule
under the Congressional Review Act. Accordingly, we have prepared a RIA
that, to the best of our ability presents the costs and benefits of the
rulemaking.
C. Anticipated Effects
The RFA requires agencies to analyze options for regulatory relief
of small businesses if a rule has a significant impact on a substantial
number of small entities. The great majority of hospitals and most
other health care providers and suppliers are small entities by meeting
the Small Business Administration (SBA) definition of a small business
(in the service sector, having revenues of less than $8.0 million to
$41.5 million in any 1 year), or being nonprofit organizations. For
purposes of the RFA, we consider all hospices as small entities as that
term is used in the RFA. The Department of Health and Human Services
practice in interpreting the RFA is to consider effects economically
``significant'' only if greater than 5 percent of providers reach a
threshold of 3 to 5 percent or more of total revenue or total costs.
The effect of the FY 2022 hospice payment update percentage results in
an overall increase in estimated hospice payments of 2.3 percent, or
$530 million. The distributional effects of the proposed FY 2022
hospice wage index do not result in a greater than 5 percent of
hospices experiencing decreases in payments of 3 percent or more of
total revenue. Therefore, the Secretary has determined that this rule
will not create a significant economic impact on a substantial number
of small entities. In addition, section 1102(b) of the Act requires us
to prepare a regulatory impact analysis if a rule may have a
significant impact on the operations of a substantial number of small
rural hospitals. This analysis must conform to the provisions of
section 603 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a MSA and has fewer than 100 beds. This rule will only affect hospices.
Therefore, the Secretary has determined that this rule will not have a
significant impact on the operations of a substantial number of small
rural hospitals (see table 34).
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. The 2021 UMRA
threshold is $158 million. This rule is not anticipated to have an
effect on state, local, or tribal governments, in the aggregate, or on
the private sector of $158 million or more.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has Federalism
implications. We have reviewed this rule under these criteria of
Executive Order 13132, and have determined that it will not impose
substantial direct costs on state or local governments.
If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this proposed rule, we
should estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that will review the rule, we assume that the total number of unique
commenters on last year's proposed rule will be the number of reviewers
of this proposed rule. We acknowledge that this assumption may
understate or overstate the costs of reviewing this proposed rule. It
is possible that not all commenters reviewed last year's rule in
detail, and it is also possible that some reviewers chose not to
comment on the proposed rule. For these reasons we thought that the
number of past commenters would be a fair estimate of the number of
reviewers of this proposed rule.
Using the wage information from the Bureau of Labor Statistics
(BLS) for medical and health service managers (Code 11-9111); we
estimate that the cost of reviewing this rule is $114.24 per hour,
including overhead and fringe benefits (https://www.bls.gov/oes/current/oes_nat.htm). This proposed rule consists of approximately
55,000 words. Assuming an average reading speed of 250 words per
minute, it would take approximately 1.83 hours for the staff to review
half of it. For each hospice that reviews the rule, the estimated cost
is $209.06 (1.83 hour x $114.24). Therefore, we estimate that the total
cost of reviewing this regulation is $11,080.18 ($209.06 x 53
reviewers).
D. Detailed Economic Analysis
1. Proposed Hospice Payment Update for FY 2022
The FY 2022 hospice payment impacts appear in Table 34. We tabulate
the resulting payments according to the classifications (for example,
provider type, geographic region, facility size), and compare the
difference between current and future payments to determine the overall
impact. The first column shows the breakdown of all hospices by
provider type and control (non-profit, for-profit, government, other),
facility location, facility size. The second column shows the number of
hospices in each of the categories in the first column. The third
column shows the effect of using the FY 2022 updated wage index data.
This represents the effect of moving from the FY 2021 hospice wage
index to the FY 2022 hospice wage index. The fourth column shows the
effect of the proposed rebased labor shares. The aggregate impact of
the changes in column three and four is zero percent, due to the
hospice wage index standardization factor and the labor share
standardization factor. However, there are distributional effects of
the FY 2022 hospice wage index. The fifth column shows the effect of
the hospice payment update percentage as mandated by section
1814(i)(1)(C) of the Act, and is consistent for all providers. The 2.3
hospice payment update percentage is based on the 2.5 percent inpatient
hospital market basket update, reduced by a 0.2 percentage point
productivity adjustment. The sixth column shows the effect of all the
proposed changes on FY 2022 hospice payments. It is projected aggregate
payments would increase by 2.3 percent; assuming hospices do not change
their billing practices. As illustrated in Table 35, the combined
effects of all the proposals vary by specific types of providers and by
location.
In addition, we are providing a provider-specific impact analysis
file, which is available on our website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Regulations-and-Notices.html. We note that simulated payments are based on
utilization in FY 2020 as seen on Medicare hospice claims (accessed
from the CCW in January of 2021) and only include payments related to
the level of care and do not include payments related to the service
intensity add-on.
As illustrated in Table 35, the combined effects of all the
proposals vary by specific types of providers and by location.
BILLING CODE 4120-01-P
[[Page 19771]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.045
[[Page 19772]]
[GRAPHIC] [TIFF OMITTED] TP14AP21.046
BILLING CODE 4120-01-C
E. Alternatives Considered
For the FY 2022 Hospice Wage Index and Rate Update proposed rule,
we considered alternatives to the calculations of the wage index
standardization factor and the labor share standardization factor.
Typically, the wage index standardization factor is calculated using
the most recent, complete hospice claims data available at the time of
rulemaking. However, due to the COVID-19 PHE, we looked at using FY
2019 claims data to determine if there were significant differences
between utilizing FY 2019 and FY 2020 claims data for the calculation
of the wage index and labor share standardization factors. The wage
index standardization factors and labor share standardization factors
for each level of care calculated using the FY 2020 claims data that
was available at the time of rulemaking did not show significant
differences compared to those calculated using FY 2019 claims data. As
such, the differences between using FY 2019 and FY 2020 claims data for
rate-setting were minimal. Therefore, we will continue our practice of
using the most recent, complete hospice claims data to available at the
time of rulemaking to set payment rates.
F. Accounting Statement
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 36, we have prepared an accounting statement showing
the classification of the expenditures associated with the provisions
of this proposed rule. Table 36 provides our best estimate of the
possible changes in Medicare payments under the hospice benefit as a
result of the policies in this proposed rule. This estimate is based on
the data for 4,957 hospices in our impact analysis file, which was
constructed using FY 2020 claims available in January 2021. All
[[Page 19773]]
expenditures are classified as transfers to hospices.
[GRAPHIC] [TIFF OMITTED] TP14AP21.047
G. Conclusion
We estimate that aggregate payments to hospices in FY 2022 will
increase by $530 million as a result of the market basket update,
compared to payments in FY 2021. We estimate that in FY 2022, hospices
in urban areas will experience, on average, 2.2 percent increase in
estimated payments compared to FY 2021. While hospices in rural areas
will experience, on average, 2.6 percent increase in estimated payments
compared to FY 2021. Hospices providing services in the Outlying and
South Atlantic regions would experience the largest estimated increases
in payments of 4.4 percent and 2.9 percent, respectively. Hospices
serving patients in areas in the New England and Middle Atlantic
regions would experience, on average, the lowest estimated increase of
1.4 percent in FY 2022 payments.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 418
Health facilities, Hospice care, Medicare, Reporting and
recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below.
PART 418--HOSPICE CARE
0
1. The authority citation for part 418 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
2. Section 418.3 is amended by adding definitions for ``Pseudo-
patient'' and ``Simulation'' in alphabetical order to read as follows:
Sec. 418.3 Definitions.
* * * * *
Pseudo-patient means a person trained to participate in a role-play
situation, or a computer-based mannequin device. A pseudo-patient must
be capable of responding to and interacting with the hospice aide
trainee, and must demonstrate the general characteristics of the
primary patient population served by the hospice in key areas such as
age, frailty, functional status, cognitive status and care goals.
* * * * *
Simulation means a training and assessment technique that mimics
the reality of the homecare environment, including environmental
distractions and constraints that evoke or replicate substantial
aspects of the real world in a fully interactive fashion, in order to
teach and assess proficiency in performing skills, and to promote
decision making and critical thinking.
* * * * *
0
3. Section 418.24 is amended by:
0
a. Revising paragraphs (c) introductory text and (c)(9);
0
b. Adding paragraph (c)(10);
0
c. Redesignating paragraphs (d) through (g) as paragraphs (e) through
(h); and
0
d. Adding a new paragraph (d).
The revisions and additions read as follows:
Sec. 418.24 Election of hospice care.
* * * * *
(c) Content of hospice election statement addendum. For hospice
elections beginning on or after October 1, 2020, in the event that the
hospice determines there are conditions, items, services, or drugs that
are unrelated to the individual's terminal illness and related
conditions, the individual (or representative), non-hospice providers
furnishing such items, services, or drugs, or Medicare contractors may
request a written list as an addendum to the election statement. The
election statement addendum must include the following:
* * * * *
(9) Name and signature of the individual (or representative) and
date signed, along with a statement that signing this addendum (or its
updates) is only acknowledgement of receipt of the addendum (or its
updates) and not the individual's (or representative's) agreement with
the hospice's determinations. If a non-hospice provider or Medicare
contractor requests the addendum, the non-hospice provider or Medicare
contractor are not required to sign the addendum.
(10) Date the hospice furnished the addendum.
(d) Timeframes for the hospice election statement addendum. (1) If
the addendum is requested within the first 5 days of a hospice election
(that is, in the first 5 days of the hospice election date), the
hospice must provide this information, in writing, to the individual
(or representative), non-hospice provider, or Medicare contractor
within 5 days from the date of the request.
(2) If the addendum is requested during the course of hospice care
(that is, after the first 5 days of the hospice election date), the
hospice must provide this information, in writing, within 3 days of the
request to the requesting individual (or representative), non-hospice
provider, or Medicare contractor.
(3) If there are any changes to the plan of care during the course
of hospice care, the hospice must update the addendum and provide these
updates, in writing, to the individual (or representative) in order to
communicate these changes to the individual (or representative).
(4) If the individual dies, revokes, or is discharged within the
required timeframe for furnishing the addendum (as outlined in
paragraphs (d)(1) and (2)
[[Page 19774]]
of this section, and before the hospice has furnished the addendum, the
addendum would not be required to be furnished to the individual (or
representative). The hospice must note the reason the addendum was not
furnished to the patient and the addendum would become part of the
patient's medical record if the hospice has completed it at the time of
discharge, revocation, or death.
(5) If the beneficiary dies, revokes, or is discharged prior to
signing the addendum (as outlined in paragraphs (d)(1) and (2) of this
section), the addendum would not be required to be furnished to the
individual (or representative). The hospice must note the reason the
addendum was not signed and the addendum would become part of the
patient's medical record.
* * * * *
0
4. Section 418.76 is amended by revising paragraphs (c)(1) and
(h)(1)(iii) to read as follows:
Sec. 418.76 Condition of participation: Hospice aide and homemaker
services.
* * * * *
(c) * * *
(1) The competency evaluation must address each of the subjects
listed in paragraph (b)(3) of this section. Subject areas specified
under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section
must be evaluated by observing an aide's performance of the task with a
patient or pseudo-patient. The remaining subject areas may be evaluated
through written examination, oral examination, or after observation of
a hospice aide with a patient or a pseudo-patient during a simulation.
* * * * *
(h) * * *
(1) * * *
(iii) If an area of concern is verified by the hospice during the
on-site visit, then the hospice must conduct, and the hospice aide must
complete, a competency evaluation of the deficient skill and all
related skill(s) in accordance with paragraph (c) of this section.
* * * * *
0
5. Section 418.309 is amended by revising paragraphs (a)(1) and (2) to
read as follows:
Sec. 418.309 Hospice aggregate cap.
* * * * *
(a) * * *
(1) For accounting years that end on or before September 30, 2016
and end on or after October 1, 2030, the cap amount is adjusted for
inflation by using the percentage change in the medical care
expenditure category of the Consumer Price Index (CPI) for urban
consumers that is published by the Bureau of Labor Statistics. This
adjustment is made using the change in the CPI from March 1984 to the
fifth month of the cap year.
(2) For accounting years that end after September 30, 2016, and
before October 1, 2030, the cap amount is the cap amount for the
preceding accounting year updated by the percentage update to payment
rates for hospice care for services furnished during the fiscal year
beginning on the October 1 preceding the beginning of the accounting
year as determined pursuant to section 1814(i)(1)(C) of the Act
(including the application of any productivity or other adjustments to
the hospice percentage update).
* * * * *
0
6. Section 418.312 is amended by revising paragraph (b) to read as
follows:
Sec. 418.312 Data submission requirements under the hospice quality
reporting program.
* * * * *
(b) Submission of Hospice Quality Reporting Program data. (1)
Standardized set of admission and discharge items Hospices are required
to complete and submit an admission Hospice Item Set (HIS) and a
discharge HIS for each patient to capture patient-level data,
regardless of payer or patient age. The HIS is a standardized set of
items intended to capture patient-level data.
(2) Administrative data, such as Medicare claims data, used for
hospice quality measures to capture services throughout the hospice
stay, are required and automatically meet the HQRP requirements for
Sec. 418.306(b)(2).
(3) CMS may remove a quality measure from the Hospice QRP based on
one or more of the following factors:
(i) Measure performance among hospices is so high and unvarying
that meaningful distinctions in improvements in performance can no
longer be made.
(ii) Performance or improvement on a measure does not result in
better patient outcomes.
(iii) A measure does not align with current clinical guidelines or
practice.
(iv) The availability of a more broadly applicable (across
settings, populations, or conditions) measure for the particular topic.
(v) The availability of a measure that is more proximal in time to
desired patient outcomes for the particular topic.
(vi) The availability of a measure that is more strongly associated
with desired patient outcomes for the particular topic.
(vii) Collection or public reporting of a measure leads to negative
unintended consequences other than patient harm.
(viii) The costs associated with a measure outweigh the benefit of
its continued use in the program.
* * * * *
Dated: March 29, 2021.
Elizabeth Richter,
Acting Administrator, Centers for Medicare & Medicaid Services.
Dated: April 6, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-07344 Filed 4-8-21; 4:15 pm]
BILLING CODE 4120-01-P