Medicare Program; FY 2020 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements, 38484-38544 [2019-16583]
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Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Rules and Regulations
by using the current year’s hospital
wage data to establish the hospice wage
index. In addition, this rule modifies the
hospice election statement by requiring
an addendum that includes information
aimed at increasing coverage
transparency for patients under a
hospice election. Finally, this rule
includes changes to the Hospice Quality
Reporting Program.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 418
[CMS–1714–F]
RIN 0938–AT71
Medicare Program; FY 2020 Hospice
Wage Index and Payment Rate Update
and Hospice Quality Reporting
Requirements
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
This final rule updates the
hospice wage index, payment rates, and
cap amount for fiscal year 2020. This
rule also rebases the continuous home
care, general inpatient care, and the
inpatient respite care per diem payment
rates in a budget-neutral manner to
more accurately align Medicare
payments with the costs of providing
care. In addition, this rule modifies the
election statement by requiring an
addendum that includes information
aimed at increasing coverage
transparency for patient under a hospice
election. Finally, this rule includes
changes to the Hospice Quality
Reporting Program.
DATES: These regulations are effective
on October 1, 2019.
FOR FURTHER INFORMATION CONTACT: For
general questions about hospice
payment policy, send your inquiry via
email to: hospicepolicy@cms.hhs.gov.
Debra Dean-Whittaker, (410) 786–
0848 for questions regarding the
CAHPS® Hospice Survey.
Cindy Massuda, (410) 786–0652 for
questions regarding the hospice quality
reporting program.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Executive Summary
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A. Purpose
This final rule makes updates to the
hospice wage index, payment rates, and
cap amount for fiscal year (FY) 2020, as
required under section 1814(i) of the
Social Security Act (the Act). This rule
also rebases the continuous home care
(CHC), general inpatient care (GIP), and
inpatient respite care (IRC) per diem
payment rates in a budget neutral
manner to more accurately align
payments with the costs of providing
care, using the hospice payment reform
authority under section 1814(i)(6) of the
Act. This rule changes the hospice wage
index to remove the 1-year lag in data
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B. Summary of the Major Provisions
Section III.A.2 of this final rule
describes the FY 2020 hospice per diem
payment rebasing methodology, cost
reports and calculations. Using the
hospice payment reform authority under
section 1814(i)(6) of the Act, section
III.A.3 of this final rule rebases the FY
2020 per diem payment rates for CHC,
IRC, and GIP levels of care. As required
in section 1814(i)(6)(D)(ii) of the Act,
any changes to hospice payment rates
must be done in a budget neutral
manner. As such, section III.A.3 also
finalizes a reduction to the routine
home care (RHC) payment amounts for
FY 2020 in order to maintain overall
budget neutrality. Section III.B.1 of this
rule eliminates the 1-year lag of the prefloor, pre-reclassified hospital wage
index that is used in calculating the
hospice wage index. Section III.B.2
updates 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.B.3
of this rule, we discuss the FY 2020
hospice payment update percentage of
2.6 percent. Section III.B.4 outlines the
final FY 2020 hospice payment rates.
Section III.B.5 of this final rule updates
the hospice cap amount for FY 2020 by
the hospice payment update percentage
discussed in section III.B.3 of this rule.
Section III.C modifies the hospice
election statement content requirements
at § 418.24(b) to increase coverage
transparency for patients under a
hospice election by notifying
beneficiaries if there are services that
will not be covered by the hospice.
Finally, in section III.E of this rule, we
discuss updates to the Hospice Quality
Reporting Program (HQRP), including:
The development of claims-based and
outcome measures, measure concepts,
and the hospice assessment tool. We
also provide updates on the public
reporting change for the ‘‘Hospice Visits
When Death is Imminent’’ measure pair,
the posting of publicly available
government data to the CMS Hospice
Compare website, and the CAHPS®
Hospice Survey.
C. Summary of Impacts
The overall economic impact of this
final rule is estimated to be $520 million
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in increased payments to hospices for
FY 2020.
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/caregivercentered care for those who are
terminally ill.
As referenced in our regulations at
§ 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 § 418.3; that
is, the individual’s prognosis is for a life
expectancy of 6 months or less if the
terminal illness runs its normal course.
The regulations at § 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 services.
These hospice services are provided
primarily in the individual’s home. The
hospice interdisciplinary group works
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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 Medicarecertified hospice freestanding facility,
skilled nursing facility, or hospital. GIP
is provided to ensure that any new or
worsening symptoms are intensively
addressed so that the beneficiary can
return to his or her home and continue
to receive routine home care. Limited,
short-term, intermittent, inpatient
respite care (IRC) is also available
because of the absence or need for relief
of the family or other caregivers.
Additionally, an individual can receive
continuous home care (CHC) during a
period of crisis in which an individual
requires continuous care to achieve
palliation or management of acute
medical symptoms so that the
individual can remain at home. CHC
may be covered for as much as 24 hours
a day, and these periods must be
predominantly nursing care, in
accordance with our regulations at
§ 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 (§ 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
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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requirements may be found at: https://
www.hhs.gov/ocr/civilrights.
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; speechlanguage pathology therapy; medical
social services; home health aide
services (now called hospice aide
services); physician services;
homemaker services; medical supplies
(including drugs and biologicals);
medical appliances; counseling services
(including dietary counseling); shortterm 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, that 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 (described in
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 these
services are not reimbursed by Medicare
(see 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
interdisciplinary group should comprise
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
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spirit of hospices.’’ This expectation
supports the hospice philosophy of
community based, holistic,
comprehensive, and compassionate endof-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 our 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 in one
of four prospectively-determined rate
categories of hospice care (routine home
care (RHC), CHC, IRC, and GIP), based
on each day a qualified Medicare
beneficiary is under hospice care (once
the individual has elected). This per
diem payment is to include all of the
hospice services and items needed to
manage the beneficiary’s care, as
required by section 1861(dd)(1) of the
Act. There has been little change in the
hospice payment structure since the
benefit’s inception. The per diem rate
based on level of care was established
in 1983, and this payment structure
remains today with some adjustments,
as noted below.
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.
3. FY 1998 Hospice Wage Index Final
Rule
The FY 1998 Hospice Wage Index
final rule (62 FR 42860), implemented a
new methodology for calculating the
hospice wage index and instituted an
annual Budget Neutrality Adjustment
Factor (BNAF) so aggregate Medicare
payments to hospices would remain
budget neutral to payments calculated
using the 1983 wage index.
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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 phaseout 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.
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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 is 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. Beginning in FY
2014, hospices that fail to report quality
data have their market basket percentage
increase reduced by 2 percentage points.
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, we
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
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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, we were 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)
we announced that beginning in 2012,
the hospice aggregate cap would be
calculated using the patient-by-patient
proportional methodology, within
certain limits. We allowed existing
hospices 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. 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).
Similar to 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 or 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,
eligibility criteria, survey respondents,
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and implementation of 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 failed to timely submit
their aggregate cap determinations had
their payments suspended until the
determination is completed and
received by the Medicare contractor (79
FR 50503).
8. 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 update rather than using the
consumer price index for urban
consumers (CPI–U) for medical care
expenditures.
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
47172), we created two different
payment rates for RHC that resulted in
a higher base payment rate for the first
60 days of hospice care and a reduced
base payment rate for subsequent days
of hospice care. We also created a
Service Intensity Add-on (SIA) payment
payable for services during the last 7
days of the beneficiary’s life, equal to
the CHC hourly payment rate multiplied
by the amount of direct patient care
provided by a registered nurse (RN) or
social worker that occurs during the last
7 days (80 FR 47177).
In addition to the hospice payment
reform changes discussed, the FY 2016
Hospice Wage Index and Rate Update
final rule (80 FR 47186) implemented
changes mandated by the IMPACT Act,
in which the cap amount for accounting
years that end after September 30, 2016
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and before October 1, 2025 is updated
by the hospice payment update
percentage rather than using the CPI–U.
This was applied to the 2016 cap year,
starting on November 1, 2015 and
ending on October 31, 2016. In addition,
we finalized a provision to align the cap
accounting year for both the inpatient
cap and the hospice aggregate cap with
the fiscal year for FY 2017 and
thereafter. Finally, the FY 2016 Hospice
Wage Index and Rate Update final rule
(80 FR 47144) clarified that hospices
must report all diagnoses of the
beneficiary 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), we finalized several new
policies and requirements related to the
HQRP. First, we codified our 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, we would continue to utilize
the measure in its new endorsed status,
without going through new notice-andcomment rulemaking. We would
continue to use rulemaking to adopt
substantive updates made by the NQF to
the endorsed measures we have 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 MeasureComprehensive Assessment at
Admission (81 FR 52173). The data
collection mechanism for both of these
measures is the HIS, and the measures
were effective April 1, 2017. Regarding
the CAHPS® Hospice Survey, we
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
Consumer Assessment of Healthcare
Providers and Systems (CAHPS®)
requirements due to newness (81 FR
52182). The exemption is determined by
CMS and is for 1 year only.
D. Trends in Medicare Hospice
Utilization
Since the implementation of the
hospice benefit in 1983, there has been
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substantial growth in hospice
utilization. The number of Medicare
beneficiaries receiving hospice services
has grown from 513,000 in FY 2000 to
over 1.5 million in FY 2018. Medicare
hospice expenditures have risen from
$2.8 billion in FY 2000 to
approximately $18.7 billion in FY 2018.
CMS’ Office of the Actuary (OACT)
projects that hospice expenditures are
expected to continue to increase, by
approximately 8.5 percent annually,
reflecting an increase in the number of
Medicare beneficiaries, more beneficiary
awareness of the Medicare hospice
benefit for end-of-life care, and a
growing preference for care provided in
home and community-based settings.
As a part of our ongoing analysis of
hospice utilization trends, we examined
the distribution of total hospice days by
level of care. A review of claims over
the last 10 years shows that RHC
remains the highest utilized level of
care, accounting for an average of 97.6
percent of total hospice days; GIP
accounting for 1.7 percent of total
hospice days; CHC accounting for 0.4
percent of total hospice days; and, IRC
accounting for 0.3 percent of total
hospice days.
There have also been notable changes
in the diagnosis patterns among
Medicare hospice enrollees. At the time
of the implementation of the Medicare
hospice benefit, cancer diagnoses were
the most frequently reported diagnoses.
However, there has been a significant
increase in the reporting of
neurologically-based diagnoses,
including Alzheimer’s disease, which
has been the top-reported diagnosis on
hospice claims since 2014. In the FY
2014 hospice final rule (78 FR 48242),
we clarified that ‘‘Debility’’ or ‘‘adult
failure to thrive’’ should not be used as
a principal hospice diagnosis on the
Hospice claim form per ICD–9–CM
Coding Guidelines. Since this
clarification, there has been an increase
in the reporting of neurological
conditions as the principal diagnosis on
hospice claims. Our ongoing analysis of
diagnosis reporting trends finds that
neurological and organ-based failure
conditions remain top-reported
principal diagnoses.
In the FY 2016 Hospice Wage Index
and Rate Update final rule (80 FR
47201), we clarified that hospices are to
report all diagnoses identified in the
initial and comprehensive assessments
on hospice claims, whether related or
unrelated to the terminal prognosis of
the individual, effective October 1,
2015. Analysis of FY 2018 hospice
claims show that 100 percent of claims
included at least one diagnosis, 90.3
percent of claims included at least two
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38487
diagnoses, and 82.1 percent of claims
included at least three diagnoses.
III. Provisions of the Final Rule
A. Rebasing of the Continuous Home
Care, Inpatient Respite Care, and
General Inpatient Care Payment Rates
for FY 2020
1. Background
Sections 1812(d), 1813(a)(4),
1814(a)(7), 1814(i), and 1861(dd) of the
Act, and our regulations in 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 in 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
a hospice election. These per diem
payments include reimbursement for all
of the hospice services and items
needed to manage the beneficiary’s care,
as required by section 1861(dd)(1) of the
Act. There has been little change in the
hospice payment structure since the
benefit’s inception. The per diem rate
based on level of care was established
in 1983, and this payment structure
remains today.
We originally set the base payment
rates for each level of care in 1983 using
information from a relatively small set
(n=26) of hospices that were
participating in a CMS hospice
demonstration. As a result of
technological changes to providing
hospice care that have occurred since
the early 1980’s, as well as changes in
the patient population that uses the
hospice benefit, it is possible that the
current per diem payment rates for the
Medicare hospice benefit do not align
accurately with the costs of providing
care. Since the establishment of the
hospice benefit, the base payment rates
have been updated through the years to
primarily account for inflation, but we
have not implemented any large scale
changes to reflect non-inflationary
changes in costs over time, with the
exception of the bifurcation of the RHC
payment rate and the creation of the SIA
payment finalized in the FY 2016
Hospice Wage Index and Payment Rate
Update final rule implemented on
January 1, 2016 (80 FR 47142). For over
a decade, MedPAC and other
organizations reported findings that
suggested that the hospice benefit’s
fixed per-diem payment system was
inconsistent with the true variance of
service costs over the course of an
episode.
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In the FY 2020 proposed rule (84 FR
17577) we described the information
that was collected on hospice claims
effective April 1, 2014 and additional
changes in reporting requirements over
the following years.2 The revised cost
report expands data collection
requirements to supply greater detail
related to hospice costs by level of care.
Hospices are required to report all direct
patient care costs by multiple cost
categories into the respective level of
care. MedPAC, the Government
Accountability Office (GAO), and the
Office of the Inspector General (OIG)
have all recommended that CMS collect
more comprehensive data to better
evaluate trends in utilization of the
Medicare hospice benefit.
Effective for cost reporting periods
beginning on or after October 1, 2014,
freestanding hospices are required to
file the revised hospice cost report
(Form CMS–1984–14). Provider-based
hospices began using the revised cost
report form for cost reporting periods
beginning on or after October 1, 2015.
The revised cost report expands data
collection requirements to supply
greater detail related to hospice costs by
level of care. Hospices are required to
report all direct patient care costs by
multiple cost categories into the
respective level of care. Within the
revised cost report changes in 2014,
there were modifications in the manner
in which general service costs and
statistical information is accumulated
by the hospice and an expansion of the
general service cost centers. Instructions
for completing the freestanding hospice
cost report (Form CMS–1984–14) are
found in the Medicare Provider
Reimbursement Manual—Part 2,
Chapter 43.3
In its March 2018 Report to the
Congress, MedPAC stated Medicare’s
payment rates for the CHC, IRC and GIP
levels of care appear to be lower than
the average and median costs per day
for freestanding providers and suggested
that rebalancing the payment rates may
be warranted.4 Additionally, we
received public comments on past rules
that indicated the payment rates for
CHC, IRC and GIP are much different
2 CMS Transmittal 2864. Additional Data
Reporting Requirements for Hospice Claims.
https://www.cms.gov/Regulations-and-Guidance/
Guidance/Transmittals/Downloads/R2864CP.pdf.
3 The Provider Reimbursement Manual—Part 2.
https://www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/Paper-Based-Manuals-Items/
CMS021935.html.
4 Medicare Payment Advisory Commission
(MedPAC). ‘‘Hospice Services.’’ Report to the
Congress: Medicare Payment Policy. Washington,
DC. March 2018. P. 341. https://www.medpac.gov/
docs/default-source/reports/mar18_medpac_ch12_
sec.pdf?sfvrsn=0.
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from the average costs of providing
those levels of care.
2. Methodology and Analysis of Costs
per Day for Continuous Home Care,
Inpatient Respite Care, and General
Inpatient Care
a. Hospice Cost Report Data
Using information collected from the
revised hospice cost report, for the first
time, we are able to estimate hospices’
average costs per day by level of care.
As required by section 1814(i)(1)(A) of
the Act, payment for hospice services
must be an amount equal to the costs
which are reasonable and related to
providing hospice care, or which are
based on such other tests of
reasonableness as the Secretary may
prescribe in regulations. Therefore,
given that we now have several years’
worth of cost report data from the
revised hospice cost report, we
calculated the average costs per day by
level of care and compared such costs
to the per diem payment rates by level
of care to determine if there is a
misalignment between payment and
costs and whether the per diem
payment rates for CHC, IRC, and GIP
should be rebased. To conduct this
analysis, we used a variety of different
data sources, including cost reports and
hospice claims data. In the FY 2020
proposed rule, we provided a
walkthrough of the methodology and
analysis of costs per day for continuous
home care, inpatient respite care, and
general inpatient care (84 FR 17578).
For this final rule, although we used
more recent cost report and claims data
(still covering FY 2017), the
methodology to calculate such costs
remains the same as in the FY 2020
proposed rule.
Our analysis was based on
information obtained from the
Healthcare Cost Report Information
System (HCRIS). The hospice cost report
data contains cost and statistical data for
freestanding and provider-based hospice
providers. To determine the average perday costs of providing hospice services,
we conducted initial analysis of both
freestanding and provider-based hospice
cost reports.5
As mentioned in the FY 2020
proposed rule (84 FR 17578), to create
the initial analytic file, we took a
number of data cleaning steps to
exclude certain hospices such as
excluding a small number of hospices
(as represented by CCN) that had
multiple FY 2017 cost reports in the
HCRIS cost report data file (exclusion
1). For those hospices, we kept the cost
5 Cost reports from FY 2017 had a start date on
or after October 1, 2016 and before October 1, 2017.
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report that covered the greatest length of
time in FY 2017.6 We eliminated SNF,
HHA, and hospital cost reports that did
not contain a hospice CCN (exclusion
2); and we eliminated cost reports (as
represented by CCN) due to the same
CCN listed multiple times (that is, there
might be two separate reports of RHC
costs for the same CCN within a
provider-based cost report, or a CCN
appeared in a freestanding cost report as
well as appeared in a provider based
cost report)(exclusion 3). In order to
limit each hospice to one single cost
report, we selected the cost report with
the highest RHC cost.7
Next, we constructed a series of flags
to identify hospice cost reports that did
not fill out fields that we would expect
hospices to report (for example, nursing
services). We identified those cost
report fields using information from the
Provider Reimbursement Manual—Part
2, Provider Cost Reporting Forms and
Instructions, Chapter 43, Form CMS–
1984–14, Transmittal 3, dated April 13,
2018, that updated cost reporting
instructions for freestanding hospice
cost reports.8 These instructions
describe a number of 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.
Finally, to remove outliers from this
analysis, we applied another set of
exclusions as described in the FY 2019
Hospice Wage Index and Payment Rate
Update proposed rule (83 FR 20948).
For each calculated outcome (for
example, average RHC costs per day),
we excluded those values that are above
the 99th percentile and those values that
are below the 1st percentile. We refer to
this trim as the ‘‘1% Trim’’. After
applying the trimming exclusions,
including the Level I edits, 1,232
freestanding hospice cost reports
remained as noted in Table 1 below:
6 We determined the length of the cost report by
subtracting the cost reports fiscal year begin date
from the cost reports fiscal year end date.
7 For example, in one home health agency-based
cost report, the home health agency reported costs
for the same hospice CCN three different times on
the same cost report.
8 Medicare Provider Reimbursement Manual—
Part 2, Provider Cost Reporting Forms and
Instructions, Chapter 43, Form CMS–1984–14.
https://www.cms.gov/Regulations-and-Guidance/
Guidance/Transmittals/2018Downloads/
R3P243.pdf.
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TABLE 1—NUMBER OF FY 2017 FREE- b. Hospice Claims Data
STANDING HOSPICE COST REPORTS
We created an analytic data set based
AFTER THE LEVEL I EDITS EXCLU- on Medicare hospice claims
SION AND 1% TRIM
downloaded from the Chronic
Number of
cost reports
after
exclusions
Level of care
RHC .....................
GIP ......................
CHC .....................
IRC ......................
1,109
817
440
915
Number of
days by level
of care
(FY2017)
43,255,420
790,195
187,554
135,384
Note: We begin with the 3,223 freestanding cost
reports that remained after applying exclusions in 1–
3. After applying the Level I edits, 1,232 freestanding
cost reports remained. Not all cost reports contain information on each level of care. Numbers noted
above indicate the number of cost reports available
for analysis for each level of care after all exclusions,
including the 1% trim are applied.
Condition Data Warehouse—Virtual
Research Data Center (CCW VRDC) to
examine hospice utilization on specific
days during FY 2017. We assigned a
wage index (using the FY 2017 hospice
wage indices) to each day of hospice
service based on the core-based
statistical area (CBSA) where a
particular day’s hospice services took
place.9 We merged information from the
June 2018 release of the CMS Provider
of Services (POS) file to identify
characteristics of each hospice
including: Ownership type, census
division (based on the hospice’s state),
and whether the hospice’s main office
was located either in an urban or rural
38489
location. This data was used in the
subsequent section in calculating costs
per day by level of care.
c. Calculating Costs per Day by Level of
Care
In order to compute the average cost
per day for each level of care using
information from the freestanding
hospice cost reports, after applying the
exclusions, we made several
adjustments to the average cost
calculations, as described in the FY
2020 proposed rule (84 FR 17580).
It is important to calculate average
costs after removing any regional
differences that may be driven by wages,
otherwise we would over-adjust for
wage differences across regions. For
example, we remove the wage
differences in RHC costs by calculating
the following value for each hospice:
Adjusted RHC cost per day = (RHC cost per day from 2017 cost reports) * (0.6871) / (Hospice’s average wage index for all RHC days in FY
2017) + (RHC cost per day from 2017 cost reports) * (1¥0.6871)
We perform a similar calculation for
the other levels of care using the
corresponding cost per day from FY
2017 cost reports and the appropriate
labor share for CHC, IRC, and GIP. For
example, the adjusted GIP cost per day
uses the same formula, but instead
includes GIP cost per day from FY 2017
cost reports, the hospice’s average wage
index for all GIP days in the formula,
and the GIP labor share of 64.01 percent.
Due to exclusions mentioned
previously, not all hospices that
submitted claims during FY 2017 have
a corresponding cost report in our final
sample. As a result, the characteristics
of the sample of cost reports used to
calculate average cost per day for each
level of care do not necessarily match
up with the characteristics of all
hospices that submitted claims during
FY 2017. If not accounted for, our
sample of cost reports may over
represent certain types of hospices. To
correct for this, we categorize each
hospice in our sample by facility type,10
ownership type,11 urban/rural status,12
and size.13
For each category of hospices and the
calculations for each level of care, we
use the following steps:
1. Using claims, we compute the total
number of days provided in FY 2017 by
all hospices within a particular
category;
2. We compute the total number of
days, as reported on the claims provided
in FY 2017, using only the hospices in
our trimmed sample of cost reports
within a particular category; and
3. For each level of care and each
category of hospices, we construct a
ratio using the value in Step 1 over the
value in Step 2.
For each cost report in our sample, we
multiply each provider’s days (as
reported on claims) by level of care by
the ratio in order to make the sample
cost reports more representative of the
overall population of hospices. We then
multiply the provider’s average per
diem cost as reported on the cost report
times the number of adjusted days from
the prior step to yield total costs by
level of care for that provider. We then
compute the weighted average for each
level of care by summing across
hospices the total costs by level of care
divided by the sum of the adjusted days
across the cost reports in our sample.14
Medicare pays for the CHC level of
care using a per hour rate instead of a
per day rate. We calculated each
hospice’s hourly cost of CHC by taking
their CHC cost per day from the hospice
cost report and dividing it by their
average number of hours of CHC
provided on CHC days occurring in FY
2017 as reported on each hospice’s
claims. Each hospice’s CHC cost per
hour (adjusted by average number of
hours of CHC) is then averaged (using
the weighted average formula discussed
above) across all hospices in our sample
to create the overall average of CHC cost
9 FY 2017 Final Hospice Wage Index. https://
www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/Hospice/Hospice-Wage-Index/FY-2017Final-Hospice-Wage-Index.html?
DLPage=1&DLEntries
=10&DLSort=0&;DLSortDir=descending.
10 Freestanding versus provider-based.
11 We only divide the freestanding cost reports
into ownership type categories. We use the
ownership type categories from the POS: For-profit,
government, non-profit, and other. Due to limited
sample size we do not break out the provider-based
hospices into ownership type.
12 Urban/rural status is reported on the POS and
corresponds to the mailing address of the hospice.
13 We divide hospices into three categories based
on their number of RHC days in FY 2017: Large
(>=20,000 RHC days), medium (3,500–19,999 RHC
days), and small (0–3,499 RHC days).
14 The formula describes the average cost per day
calculation for IRC, however, the same formula can
be adapted for each level of care.
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per hour. To convert the CHC cost per
hour into a CHC cost per day we
multiply the average CHC cost per hour
by 24 hours. It is important to note that
each hospice’s hourly CHC cost is based
on their average number of CHC
minutes per day, which is less than 24
hours. That means a full CHC per day
payment (which covers 24 hours) will
be larger than the average CHC cost per
day (which covers a time period less
than 24 hours). Applying all of the steps
as described above and in the FY 2020
proposed rule, average costs per day by
level of care in FY 2017 are listed in
Table 2 below:
TABLE 2—AVERAGE COST PER DAY BY
LEVEL OF CARE, FY 2017
Average cost
per day
Level of care
RHC ......................................
CHC (24 Hours) ....................
CHC (Per Hour) ....................
IRC ........................................
$130.85
1,307.76
54.49
441.03
• Days 1 through 60: The ratio of
TABLE 2—AVERAGE COST PER DAY BY
LEVEL OF CARE, FY 2017—Continued average resource use for RHC days in
days 1 through 60 to average resource
use across all RHC days was 1.2603 to
Level of care
1.
• Days 61 and beyond: The ratio of
GIP ........................................
952.56
average resource use for RHC days after
The current payment system pays
day 60 to the average resource use
hospices a two-tiered rate for RHC. RHC across all RHC days was 0.8722 to 1.
days during the first 60 days are paid a
We multiplied the labor share
higher per diem rate compared to any
component of the average cost per day
RHC days after day 60. Hospice do not
for RHC in FY 2017 by the
report RHC costs separately for the first
corresponding resource use ratio to
60 days versus RHC days after day 60.
However, we can estimate the RHC costs calculate the average cost per day for the
first 60 days and any RHC days after 60
in the first 60 days versus after 60 days
days. We only applied the resource ratio
by making the same assumption that
to the labor share component because
was made to calculate the two-tiered
the resource ratio is calculated using
payment. That is, in the FY 2016
minutes of direct patient care as
hospice final rule (80 FR 47166), we
reported on the claims. This approach is
calculated resource use ratios to
consistent with what was done in the
determine the differences in resource
FY 2016 hospice final rule (80 FR
utilization for the first 60 days and any
47166) to construct the two-tiered
RHC days after day 60. For the creation
of the two-tiered RHC rate (80 FR
payment. The resulting average cost per
47166), the following ratios were used:
day for RHC is shown in Table 3.
Average cost
per day
TABLE 3—AVERAGE RHC COSTS
[FY 2017 per day for days 1 through 60 and days 61+]
Average cost
per day
RHC level of care
Days 1–60 ..................................................................................................................
Days 61+ ....................................................................................................................
To determine if there is any
misalignment between the average costs
of providing CHC, IRC and GIP and the
per diem payment rates for these levels
of care, we inflated the average costs in
FY 2017 to FY 2019 dollars. We did this
Resource use
ratio (only
applied to the
labor share,
which is 68.71%
of the RHC
payment rate)
$130.85
130.85
by multiplying the average FY 2017
costs by level of care by the hospice
market basket update for FY 2018 (82
FR 36649) and FY 2019 (83 FR 38630)
less the multifactor productivity (MFP)
adjustments corresponding to each year.
1.2603
0.8722
Average cost
per day
in FY2017
(based on
days of RHC)
$154.25
119.36
The estimated average costs for FY 2019
(that is, taking the average FY 2017 cost
per day by each level of care inflated to
FY 2019 dollars) is detailed in Table 4.
TABLE 4—ESTIMATED AVERAGE COSTS (FY 2019) FOR CHC, IRC, AND GIP
FY 2017
average costs
Level of care
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CHC (per Hour) .......................................................................
IRC ...........................................................................................
GIP ...........................................................................................
We also analyzed the average costs of
RHC for the first 60 days and any RHC
days after day 60 inflated from FY 2017
dollars to FY 2019 dollars by applying
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FY 2018 hospice
market basket
update less
productivity
adjustment
$54.49
441.03
952.56
x1.021
x1.021
x1.021
the hospice market basket update for FY
2018 and FY 2019 less the MFP
adjustments corresponding to each year.
The estimated average costs for RHC by
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FY 2019 hospice
market basket
update less
productivity
adjustment
x1.021
x1.021
x1.021
FY 2019
estimated
average costs
$56.80
459.75
992.99
days for FY 2019 is shown in Table 5
below.
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TABLE 5—ESTIMATED AVERAGE COSTS FOR RHC (FY 2019) DAYS 1 THROUGH 60 AND DAYS 61+
FY 2017
average costs
Level of care
RHC Days 1–60 .......................................................................
RHC Days 61+ .........................................................................
We then compared the FY 2019
average costs for CHC, IRC and GIP to
the FY 2019 payment rates for these
three levels of care. Our analysis shows
that there is a misalignment between
average costs and payment for these
FY 2018 hospice
market basket
update less
productivity
adjustment
$154.25
119.36
FY 2019 hospice
market basket
update less
productivity
adjustment
x1.021
x1.021
three levels of care. Table 6 below
shows the percent of total hospice days
by level of care; the estimated average
FY 2019 costs by level of care; the
current FY 2019 per diem payment
rates; and the estimated percent increase
FY 2019
estimated
average costs
x1.021
x1.021
$160.80
124.43
to the payment rates to more accurately
align the per diem payments for CHC,
IRC and GIP with the costs of providing
these levels of care.
TABLE 6—COMPARISON OF FY 2019 AVERAGE COSTS TO PAYMENTS FOR CHC, IRC, AND GIP
Percent of days
by level of care
in FY 2018 *
Level of care
CHC .......................................................................................
0.2
IRC ........................................................................................
GIP ........................................................................................
0.3
1.3
Estimated FY
2019 average
costs per day
$1,363.26/$56.80
(per hour).
$459.75 ..................
$992.99 ..................
FY 2019
per diem
payment rates
Estimated
percent payment
increase needed
to align
with costs
$997.38/$41.56
+36.6
176.01
758.07
+161.2
+31.0
* Note: We used the FY 2018 percent of days by level of care as this is the most current data available.
We also compared the FY 2019
average costs for RHC for the first 60
days and for any RHC days after day 60
to the FY 2019 payment rates for RHC
and the percentage difference between
payment and average costs. The percent
difference between costs and payment
represents how much we would need to
reduce the RHC payments in order to
align payments with costs. The results
are shown in Table 7 below. However,
we did not propose to rebase the RHC
payment rates as any changes to the
CHC, IRC, and GIP payment rates must
be done in a budget-neutral manner as
required by law.
TABLE 7—COMPARISON OF FY 2019 AVERAGE COSTS TO PAYMENT FOR RHC
Estimated FY
2019 average
costs per day
Level of care
RHC Days 1–60 .........................................................................................................
RHC Days 61+ ...........................................................................................................
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3. Rebasing of the CHC, IRC, and GIP
Payment Rates for FY 2020
As described in the proposed rule (84
FR 17582) and in this final rule, the
average costs of providing CHC, IRC and
GIP are significantly higher than the
payment amounts for these three levels
of care. Using the hospice payment
reform authority under section
1814(i)(6) of the Act, in the FY 2020
proposed rule., we proposed to rebase
the payment rates for CHC, IRC, and GIP
by setting these payment amounts equal
to the FY 2019 estimated average costs
per day, as described in the
methodology above, before application
of the hospice payment update
percentage outlined in section III.B.3 of
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$160.80
124.43
this final rule. Using the updated cost
report and claims data as shown
previously in this final rule, the rebased
payment rates for CHC, IRC, and GIP are
as follows:
TABLE 8—REBASED PAYMENT RATES
FOR CHC, IRC, AND GIP *
Level of care
Continuous Home Care
(CHC).
Inpatient Respite Care
(IRC).
General Inpatient Care
(GIP).
Rebased payment rates *
$56.80 per hour/
$1,363.26 (per day.**
$437.86.***
$992.99.
* Prior to application of the hospice payment update of 2.6 percent outlined in section III.B.3 of this
final rule.
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FY 2019
payment rates
$196.25
154.21
Percent
difference
between
costs and
payment
¥18.1
¥19.3
** Based on a full CHC per day payment (which
covers 24 hours).
*** IRC payment rate accounts for 5 percent coinsurance ($459.75/1.05 = $437.86).
Section 1813(a)(4)(A)(ii) of the Act
states that the amount payable for
hospice care shall be reduced in the
case of respite care provided by (or
under arrangements made by) the
hospice program, by a coinsurance
amount equal to 5 percent of the amount
estimated by the hospice program (in
accordance with regulations of the
Secretary) to be equal to the amount of
payment under section 1814(i) to that
program for respite care. To ensure
payments (both paid by Medicare and
collected from the beneficiary via
coinsurance) under a rebased IRC rate
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equal the average per-diem cost of IRC,
we set the rebased IRC payment rate
equal to the average per-diem cost of
IRC divided by 1.05. The amount of the
individual’s coinsurance liability for
respite care during a hospice
coinsurance period may not exceed the
inpatient hospital deductible applicable
for the year in which the hospice
coinsurance period began. The
individual hospice coinsurance period
begins on the first day an election is in
effect for the beneficiary and ends with
the close of the first period of 14
consecutive days on each of which an
election is not in effect for the
beneficiary.
Section 1814(i)(6)(D)(ii) of the Act
requires that any revisions to the
methodology for determining the
payment rates for other services
included in hospice care to be done in
a budget-neutral manner in the fiscal
year in which such revisions in
payment are implemented as would
have been made for care in the fiscal
year if such revisions had not been
implemented. The results of the
calculations demonstrated in the FY
2020 proposed rule (84 FR 17583) show
that in order to rebase the payment rates
for the CHC, IRC, and GIP levels of care
in a budget-neutral manner, the RHC
payment rates would need to be reduced
by 2.71 percent. The 2.71 percent
reduction would be applied to the RHC
payment rates for the first 60 days and
RHC days after day 60. However, using
more recent claims data for this final
rule, these same calculations show that
the actual reduction to the RHC
payment rate would need to be 2.72
percent. To calculate the 2.72 percent
reduction to the RHC payment rates, we
first calculated two sets of payments
using different payment parameters.
1. Total payments for hospice days
provided during FY 2018 under the
existing FY 2019 payment rates and FY
2019 wage indices.
2. Total payments for hospice days
provided during FY 2018 under a new
RHC payment rate and the rebased
payment rates for CHC, IRC, and GIP.
We set the RHC payment rate in step
(2) equal to the value that makes total
payments between step (1) and step (2)
equivalent. We calculate that rate using
the following steps:
1. We calculate the difference in
Medicare payments when using the
rebased CHC, IRC, and GIP payment
rates instead of the payment rates in
place during FY 2019.
2. We calculate one minus the value
from Step (1) over the RHC payments
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made under the payment rates in place
during FY 2019.15
3. We multiply the value in Step (2)
by each RHC payment rate (the first 60
days and any RHC days after day 60) in
place during FY 2019 to establish the
budget-neutral RHC payment rates (the
first 60 days and any RHC days after day
60).
The calculated payment rates in Step
(3) will make the total payments made
under the rebased FY 2019 payment
rates equal to the total payments made
under the existing FY 2019 payment
rates. Essentially, the reduction is the
weighted difference between non-RHC
costs and payments divided by the
weighted RHC payments, where the
weights are the percent of days by level
of care.
The results of this calculation
demonstrate that in order to rebase the
payment rates for the CHC, IRC, and GIP
levels of care in a budget neutral
manner, the RHC payment rates would
need to be reduced by 2.72 percent. The
2.72 percent reduction would be
applied to the RHC payment rates for
the first 60 days and RHC days after day
60 (that is, we would take each of the
RHC payment rates and multiply by the
0.9728 to determine the FY 2019 RHC
payment rates).
Therefore, in order to offset the
increases in payment rates to the CHC,
IRC, and GIP levels of care, we would
reduce the RHC payment rates by 2.72
percent in order to implement rebasing
in a budget-neutral manner in FY 2020.
However, reducing the RHC payment
rate to a level equal to the estimated
RHC costs would require a reduction in
the RHC payment rate that exceeds the
2.72 percent. Therefore, while we are
rebasing the per diem payment rates for
CHC, GIP, and IRC to more accurately
align the payment with costs, the
reduction to the RHC payment rates is
not considered rebasing as the 2.72
percent reduction does not bring the
RHC payment in alignment with the
costs of providing this level of care. The
purpose of the 2.72 percent reduction to
the RHC payment rates is to ensure that
the revisions to the payment rates for
CHC, GIP and IRC are made in a budgetneutral manner, in accordance with the
law.
We received 113 unique comments
regarding the rebasing methodology and
15 Using the average per-diem costs generated
from our sample of freestanding hospice cost
reports, rebasing CHC, IRC, and GIP results in extra
payments of $468,223,480.70 for those levels of
care. The RHC payments that were made under the
payment rates in place during FY 2019 were
$17,238,380,386.58. One minus the value of the
extra payments over the RHC payments equals
0.9728.
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analysis, as well as the rebased payment
rates for CHC, IRC, and GIP. Most of
these comments were from hospices,
industry associations and other relevant
stakeholders, including comments from
the Medicare Payment Advisory
Commission (MedPAC). These
comments are summarized below along
with our responses:
Comment: Several commenters were
supportive of CMS’ proposal to rebase
the per diem payment amounts for CHC,
GIP and IRC in order to ensure that
payments are closer to the estimated
cost of providing each level of care.
Commenters stated that rebasing the
rates for these three levels of care
addresses concerns that hospices lose
money on the increased costs of
providing more complex medical
management. These commenters stated
that hospices often have to pay
contractors and the facilities providing
this increased level of care more than
the payment rates the hospices are
currently receiving. Further,
commenters suggested that, were CMS
to finalize this proposal, the potential
increase in availability of hospices to
provide these levels of care would
benefit patients and their caregivers. A
few commenters stated that rebasing the
CHC, GIP, and IRC rates would benefit
rural hospices who have fewer facilities
and contractors with which to provide
this care.
Response: We thank commenters for
their thoughtful review and support of
our efforts to better align hospice costs
of providing care for patients receiving
CHC, GIP, and IRC and to support
hospices working with outside
contractors and facilities. We agree that
rebasing these rates would adequately
cover the costs of providing these higher
intensity levels of care, could ensure
that hospices have access to the
providers needed to comply with the
hospice Conditions of Participation
(CoPs), and promote patient access to all
levels of care.
Comment: CMS received several
comments about the large number of
cost reports eliminated with exclusion 2
(that is, we eliminated SNF, HHA and
hospital cost reports that did not
contain a hospice CCN) and as reported
in Table 2 of the proposed rule (84 FR
17578). Many commenters also
mentioned that CMS used cost reports
for FY 2017 and applied Level I edits;
however, the edits went into effect for
cost reporting periods that ended on or
after December 31, 2017. These
commenters expressed concern that
CMS applied the Level I edits to
freestanding and provider-based cost
reports even though the edits were not
applicable to provider-based cost
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reports for 2017 or subsequent cost
reports thus stating we shouldn’t use
them in our analysis. Several
commenters recommended that CMS
include provider-based cost reports as
the sample size used for the analysis
and methodology is relatively small.
These commenters suggested that using
larger sample of cost reports by
incorporating cost reports from
provider-based hospices when rebasing
CHC, IRC and GIP per diem rates would
provide more robust and accurate
information.
Response: For the FY 2020 final rule,
CMS updated the FY 2017 cost reports
using the hospice cost report file https://
downloads.cms.gov/Files/hcris/
HOSPC14-ALL-YEARS.zip from the
proposed rule (84 FR 17578). There are
4,195 hospice cost reports as of June 21,
2019 versus 4,125 from the proposed
rule. We describe, in detail, in this final
rule and in the FY 2020 hospice
proposed rule (84 FR 17570), all of the
exclusions applied to hospice cost
reports to estimate the average cost per
day by level of care. And in this final
rule, we remind commenters that the
final sample of cost reports is higher
than described in the proposed rule
(1,232 cost reports for this final rule
compared to 1,120 in the proposed
rule). We note that most SNFs do not
have a hospice CCN associated with it,
so most of the SNF cost reports were
dropped. We believe that eliminating
these SNF cost reports with no
associated hospice CCN would more
accurately filter out those costs not
related to the cost of providing hospice
care and where much of the reported
costs may be for the provision of SNF
services. Additionally, we considered
proposing to use freestanding and
provider-based cost reports to rebase
CHC, IRC, and GIP payment rates, rather
than just using freestanding cost reports.
However, when we analyzed both
freestanding and provider-based cost
reports, the results tend to be similar.
On average, incorporating providerbased cost reports results in higher costs
than the cost reports for freestanding
hospices only, as shown in Table 27 of
the FY 2020 hospice proposed rule (84
FR 17616).
Similarly, when we rebased the
national, standardized 60-day episode
payment rate for home health agencies
beginning in CY 2014, we estimated
costs using only freestanding HHA cost
reports for the same reasons detailed in
the FY 2020 hospice proposed rule (that
is, freestanding cost reports reflect
actual hospice costs and not those
additional costs borne from the parent
entity). Therefore, it is not
unprecedented in Medicare payment
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systems to use only freestanding cost
reports, rather than including providerbased cost reports for rebasing purposes.
Additionally, in MedPAC’s March
2018 report to Congress, MedPAC stated
that overhead costs allocated from the
parent provider are included in the
costs for provider-based hospices,
which contributes to provider-based
hospices having higher costs than
freestanding hospices. If freestanding
hospices are able to provide highquality care at a lower cost than
provider-based hospices, payment rates
should be set accordingly, and the
higher costs of provider-based hospices
should not be a reason for increasing
Medicare payment rates. Ultimately, we
used freestanding cost reports to
estimate the average cost per day by
level of care.
As detailed in the FY 2020 proposed
rule, we also applied Level I edits (and
removed certain reports with missing
data from our sample) manually because
not all FY 2017 freestanding cost reports
had a reporting period that ended on or
after December 31, 2017. We decided to
apply Level I edits based on suggestions
by industry representatives to apply
certain edits to force adherence to
certain cost-reporting principles that
could lead to the reporting of higherquality cost data. Therefore, we believe
it is most technically appropriate to
apply the Level I edits. Furthermore, we
show in Table 26 of the proposed rule
(84 FR 17616) that the differences in
costs between including and not
including exclusions based on the Level
I edits were minimal for RHC, CHC, and
GIP. The difference between applying
Level I edits versus not applying the
edits is less than one dollar for RHC,
CHC, and GIP. However, the IRC cost
per day between the two trimming
methodologies was more pronounced,
but still not significantly so. In looking
at FY 2017 estimated average per day
costs using all of the trimming
exclusions, and as shown in Table 26 in
the proposed rule, the cost for IRC was
$438.97; applying all of the trimming
exclusions, excluding the Level I edits,
the cost for IRC was $467.78 (a 6.6%
increase). Therefore, for purposes of
estimating the costs by level of care, we
believe that applying the Level I edits is
appropriate given these edits are now
applied for hospice cost reports and
there was minimal effect on the average
costs per day.
Comment: Several commenters stated
that many hospices do not accurately or
consistently complete cost reports, thus
rendering the data inaccurate. These
commenters stated that because of the
inaccuracies in the cost reports, CMS
should not use hospice cost reports as
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the source of data to estimate costs.
Several commenters mentioned
concerns about the accuracy of the cost
report data in the FY 2017 cost reports
that CMS used for their analysis and
methodology. A few commenters stated
that CMS did not provide additional
information about which provider’s data
was used.
Response: We remind hospices that
each hospice cost report is required to
be certified by the medical officer or
hospice administrator. The hospice
Medicare Cost Report (MCR) form
(CMS–1984–14) includes a dated and
signed statement indicating that all
information is true, correct, and
prepared from the books and records of
the provider in accordance with
applicable instructions, except as noted.
Additionally, as required by section
§ 413.24(f)(4)(iv)(A) the cost report must
be signed by either the Chief Financial
Officer or the Administrator. If there are
errors within a cost report, they must be
filed on time and if there is any type of
problem with it that cannot be
addressed timely, the MAC may
withhold Medicare payments.
Therefore, we expect and it is required
that hospice cost reports contain
accurate and complete data on which to
base our analyses.
As always, we encourage providers to
fill out the Medicare cost reports as
accurately as possible. The Provider
Reimbursement Manual 15 provides
detailed instructions on filling out the
cost reports. CMS further encourages
hospice providers to contact the
appropriate Medicare Administrative
Contractor (MAC) if additional
instruction or assistance is needed.
Furthermore, as the cost reports are to
reflect all of the costs associated with
providing hospice care by level of care,
we believe that it is the most
appropriate mechanism in which to
estimate costs for rebasing payment
rates.
Our cost report analysis was based on
information obtained from the
Healthcare Cost Report Information
System (HCRIS). As mentioned in the
proposed rule (84 FR 17578), the
hospice cost report data contains cost
and statistical data for freestanding and
provider-based hospice providers. For
the proposed rule, we used HCRIS data
files from December 31, 2018. For this
final rule we used more up to date cost
report data from March 31, 2019. The
updated data contains 4,195 hospice
cost reports versus 4,125 from the
15 The Provider Reimbursement Manual—Part 2.
https://www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/Paper-Based-Manuals-Items/
CMS021935.html.
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proposed rule. In our analysis, we used
Worksheet S–2 to determine if the
provider-based cost reports had a
hospice CCN. Information regarding
costs per day by level of care came from
worksheet O8 for provider-based cost
reports and worksheet C for freestanding
cost reports. Information needed to
construct the level I edits came from
worksheet A for freestanding cost
reports and worksheet O and O5 for
provider-based cost reports. We feel
confident that the cost reports that the
hospice providers submit are accurate
and that the signatures obtained by the
administrator and or Officer are true,
correct, complete, and prepared from
the books and records of the provider in
accordance with applicable instructions.
Comment: Several commenters
disagreed with the proposal to rebase
the CHC, IRC, and GIP payment rates
stating that the reduction in the RHC
payment rate in order to maintain
budget neutrality effectively turns the
rebasing proposal into a rate cut even
after the proposed payment update.
These commenters stated that this
would create financial and staffing
hardships for hospices, especially
smaller rural hospices. Some
commenters stated that payment
adjustments that more accurately
capture and compensate for differences
in costs of providing hospice services in
rural versus urban communities may
first be necessary before CMS rebases
payment rates. A few commenters stated
that the effect of rebasing will be felt
unevenly across providers, depending
on the amount of GIP, CHC and IRC
being provided by an individual hospice
and that CMS should ensure that
payment adjustments adequately
account for differences in costs based on
geography.
Response: Section 1814(i)(6)(D)(ii) of
the Act requires that any revisions to the
hospice payment rates be done in a
budget neutral manner. Meaning the
revisions in payment for GIP, IRC and
CHC must result in the same estimated
aggregate expenditures had the revisions
not been implemented. After applying
the FY 2020 hospice payment update of
2.6 percent and accounting for the
rebasing of the GIP, IRC and CHC
payment rates (which requires a 2.72
percent reduction to the RHC payment
rate) the net result would only be a
reduction of 0.19 percent to the RHC
payment rate. That reduction equates to
approximately 37 cents on RHC days 1
through 60 and 29 cents on days 61 plus
(compared to the FY 2019 RHC payment
rates). Given that MedPAC in their
recent March 2019 Report
recommended a 2 percent reduction to
the hospice base payment rates and
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projects Medicare hospice margins to be
10.1 percent for 2019, we feel the
reduction to the RHC payment rate
would not create financial hardships for
hospices. Furthermore, in their March
2019 report, and their comments on the
proposed rule, MedPAC reported that
the aggregate 2016 Medicare margin,
which is an indicator of the adequacy of
Medicare payments relative to
providers’ costs, was 10.9 percent, up
from 9.9 percent in 2015. They stated
that hospice costs per day vary
substantially by type of provider, which
is one reason for differences in hospice
margins across provider types. In 2016,
hospice costs per day across all hospice
providers were about $149 on average,
a slight decrease from $150 in the
previous year. Some of the decline in
cost per day is accounted for by a shift
in the mix of hospice days, with the
share of days accounted for by routine
home care (the lowest cost level of care)
increasing in 2016. Freestanding
hospices had lower costs per day than
provider-based hospices (that is, home
health-based hospices and hospital
based hospices). For-profit, above-cap,
and rural hospices also had lower
average costs per day than their
respective counterparts.
Our regulations at § 418.306(c) require
each labor market to be established
using the most current hospital wage
data available, including any changes
made by Office of Management and
Budget (OMB) to the Metropolitan
Statistical Areas (MSAs) definitions.
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. Overall, rural
hospices would have a slight decrease
(estimated to be less than 1 percent) in
payments as a result of the rebased
payment rates for CHC, GIP, and IRC.
However, rural, non-profit HHAs will
see an increase in payments, compared
to rural for-profit HHAs who will see a
slight decrease in payments as a result
of the rebased rates.
Comment: Several commenters,
including a national industry group,
agreed that while the CHC, IRC, and GIP
payment rates need to be increased, they
expressed concern that CMS needs to
examine any negative impact on access
to care.
Response: We disagree that increasing
the rates for CHC, IRC, and GIP would
have a negative impact on access to
care. Conversely, we believe that
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aligning the payment with the cost of
providing care should have a positive
effect on access to needed levels of care.
We believe that hospices who currently
cannot provide adequate CHC will now
have the resources to hire adequate staff
to ensure patients needing CHC level of
care will have the needed nursing
support during a time of symptom
crisis. Likewise, for those hospices who
do not have their own freestanding,
inpatient unit, we believe the higher
payment rates for IRC and GIP will
afford them more latitude when
negotiating contracts with skilled
nursing facilities and hospitals to best
meet the needs of their patients
requiring inpatient levels of care.
However, 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.
Comment: Many commenters
suggested to postpone any rebasing for
2 years so that CMS has enough time to
validate cost reports and accuracy of
data to support the changes, or at the
very least, implement a phased-in
approach to increasing the payment
rates for CHC, IRC, and GIP payment
rates and reducing the RHC payment
rates.
Response: While we understand why
some hospices would prefer to postpone
or phase-in rebasing of the CHC, IRC,
and GIP payments and the
corresponding reduction to RHC
payments to maintain budget neutrality,
we disagree with either of these
approaches as this would not align
payment with the costs of providing the
higher intensity levels of care.
We will continue to monitor
utilization with implementation of these
rebased rates to see if there are any
trends that may warrant other
appropriate actions, including program
integrity measures. Furthermore, a
phased-in approach would require a
recalculation of the RHC amount each
year based on the most recent utilization
of CHC, IRC and GIP. If there was an
increase in utilization of those levels
(CHC, IRC, GIP) we would then have to
further adjust the RHC rate to account
for the increase in utilization, which
could further reduce the RHC rate.
Likewise, even with the 2.72 percent
reduction to the RHC rates, the payment
for both days 1–60 and days 61+ still
exceeds the cost of providing this level
of care, as shown in Table 7 in this final
rule.
Comment: Several commenters noted
that the changes to the IRC per diem
payments would make it easier to
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provide respite care to patients and their
families needing such support. One
commenter noted that the rebasing of
GIP would have a positive impact on
those hospices that provide GIP in their
own freestanding facilities. Hospice
providers stated that this change would
allow their freestanding facility to
operate with positive margins for the
first time. Other commenters remarked
that the increased IRC rates will enable
them to find nursing facilities willing to
contract with them for respite stays. A
large number of commenters stated that
upward adjustment for CHC, GIP, and
IRC is warranted given the
misalignment between payment and
costs.
Response: We appreciate these
comments and agree that rebasing the
IRC payment rate may result in greater
access to inpatient respite care for
terminally ill patients and their families.
Likewise, the rebasing proposals help to
align payment with the cost of
providing care and we believe that this
proposal is responsive to industry
concerns and challenges related to
providing these higher intensity levels
of care.
Comment: Many hospices, along with
MedPAC, noted concerns about creating
incentives for hospices to improperly
expand the use of inpatient levels of
care as a result of rebasing. They
suggested considering a prospective
payment adjustment to GIP to maintain
budget neutrality if aggregate payments
increase as a result of these payment
changes. MedPAC also expressed
concern about the proposed increase in
the GIP payment rate provided in a
skilled nursing facility (SNF) and urged
CMS to maintain the current payment
rate of GIP provided in SNFs. MedPAC
cited reports from hospice providers
that it costs less to contract for GIP in
a SNF than with a hospital. A few other
commenters suggested that CMS
reconsider increasing the GIP per diem
payment rate in skilled nursing facilities
(SNFs). They suggested that an increase
in the payment rate for GIP would likely
make providing GIP in SNFs quite
profitable and could create incentives
for more hospice providers to furnish
GIP in SNFs. They further note that GIP
care in the SNF setting tends to be less
resource intensive and less costly than
in a hospital or hospice facility.
Response: We believe that the rebased
rates will help appropriately increase
access to care but we are aware of the
perverse incentives that could occur
with increases in payment rates. We
recognize that there may be an increase
in utilization of these higher intensity
levels of care but we believe that this
may be appropriate to meet patient care
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needs. We remind stakeholders that
there are criteria for receiving these
higher levels of care which may
potentially buffer any inappropriate
increases in utilization. Continuous
home care may be provided only during
a period of crisis as necessary to
maintain an individual at home. Either
homemaker or home health aide
(hospice aide) services or both may be
covered on a 24-hour continuous basis
during periods of crisis but care during
these periods must be predominantly
nursing care. A period of crisis is a
period in which a patient requires
continuous care to achieve palliation or
management of acute medical
symptoms. The hospice must provide a
minimum of 8 hours of care during a 24hour day, which begins and ends at
midnight. This care need not be
continuous; for example, 4 hours could
be provided in the morning and another
4 hours in the evening. In addition to
the 8 hour minimum, the services
provided must be predominantly
nursing care, provided by either an RN,
an LPN, or an LVN. Respite care is
short-term inpatient care provided to
the individual only when necessary to
relieve the family members or other
persons who normally care for the
individual at home. Respite care may be
provided only on an occasional basis
and may not be reimbursed for more
than 5 consecutive days at a time.
Payment for the sixth and any
subsequent day of respite care is made
at the routine home care rate, and the
patient would be liable for room and
board. Respite care cannot be provided
to hospice patients who reside in a
facility (such as a long term care nursing
facility). Provision of respite care
depends upon the needs of the patient
and of the patient’s caregiver (and is
subject to the regulatory limitations set
out at § 418.302(e)(5)). And finally, GIP
is allowed when the patient’s medical
condition warrants a short term
inpatient stay for pain control or acute
or chronic symptom management that
cannot feasibly be provided in other
settings.
To address MedPAC and other
stakeholder comments regarding the
difference in the provision of GIP in a
SNF compared to an inpatient hospital,
we note the current cost report does not
allocate costs for GIP by site of service.
Additionally, our analysis has shown
that very few GIP days are provided in
a SNF compared to other freestanding
facilities and inpatient hospitals.
Likewise, the types of hospices
providing GIP in a SNF may be different
in other ways compared to hospices that
do not provide GIP in a SNF. It is
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possible those differences are correlated
with the costs.
Additionally, we continue to expect
hospices to provide care in accordance
with the individualized plan of care as
required by the hospice CoPs at
§ 418.56. This means that we do not
expect that hospices would move
patients into higher intensity levels of
care solely to receive higher payments.
As mentioned in the proposed rule, we
believe that rebasing the per diem
payment amounts for CHC, GIP, and IRC
is appropriate in order to align
payments with cost of providing care.
Likewise, potential, subsequent
increases in utilization would not
necessarily be inappropriate. Hospice
providers still need to meet the
necessary requirements stated in section
1861(dd) of the Act and the hospice
CoPs, which require that hospice
agencies regardless of size, location or
other organizational or market
characteristics must be able to provide
all four levels of hospice care. As part
of our routine monitoring of hospice
utilization, we will continue to closely
analyze any changes in the patterns of
care in response to these rebased
payment rates to determine if any
additional actions are warranted.
Comment: Several commenters
suggested that CMS should increase its
oversight of hospice providers not
delivering the services required under
the hospice CoPs and exhibiting
inappropriate practices highlighted by
the OIG and the MedPAC.
Response: We note that compliance
with the hospice CoPs is monitored
through the survey process. The
IMPACT Act of 2014 currently requires
hospice survey/recertifications every 3
years. Survey protocols and Interpretive
Guidelines are established to provide
guidance to personnel conducting
surveys of hospices. They serve to
clarify and/or explain the intent of the
regulations. All surveyors are required
to use them in assessing compliance
with federal requirements.16 There are
different types of surveys including
survey for initial certification for
participation in Medicare; a
recertification survey which are
unannounced and must verify
compliance with all the regulatory
requirements contained at §§ 418.52
thru 418.116; a post-survey onsite
revisit is to reevaluate the specific care
and services that were cited during a
previous survey that cannot be
adequately assessed by mail, telephone
16 State Operations Manual Appendix M—
Guidance to Surveyors: Hospice. https://
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/downloads/som107ap_m_
hospice.pdf.
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or electronic contact, or; a complaint
investigation in which a survey is
conducted to investigate and resolve a
complaint against a hospice. We believe
that there are already systems in place
to ensure compliance with the hospice
CoPs and we will continue to coordinate
with the State Agencies to identify any
ongoing concerns as they relate to the
CoPs and to determine whether any
additional oversight mechanisms need
to be in place. We are committed to
encouraging providers to supply the
best quality care in the most appropriate
ways, and we will continue to work to
incentivize and monitor for the most
appropriate practices in the hospice
provider community.
Comment: Several commenters
expressed concern that increasing the
rates for IRC and GIP will result in
contracted facilities raising the rates
they charge hospices to provide these
levels of care. Stakeholders remarked
that these are essentially ‘‘pass-through
payments’’ to contracted providers and
would require hospice providers to bear
the cost of providing these services
while taking a large reduction to the
RHC reimbursements. Some
commenters stated that IRC and GIP can
be supplied by hospice in various ways
resulting in wide differences in costs for
providing these levels of care.
Commenters asserted that a small
proportion of hospices operate hospice
inpatient units directly, while some
others are system or SNF-based and
secure inpatient care through a parent
entity. They suggested that the vast
majority of hospice providers, more
than 75 percent, enter into contracts
with local hospitals or other facilities
and therefore costs for inpatient days
vary significantly. One commenter
suggested that the estimated cost of IRC
reported in the proposed rule does not
accurately reflect the average cost of
providing this level of care as it is being
affected by high cost outliers and
therefore the rebased payment rate may
be inaccurate.
Response: We remind stakeholders
that CMS does not have the authority to
mandate specific contractual agreements
between hospices and other entities
which have entered into an agreement
to provide arranged hospice services.
Hospices are required, in accordance
with the CoPs at §§ 418.100 and
418.108, to be able to provide all levels
of hospice care. This means it is the
responsibility of hospices to secure the
necessary contracts to provide inpatient
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levels of care if the hospice does not
provide them in their own freestanding
facility. As such, hospices would have
to negotiate appropriate rates with the
contracted providers to ensure that the
hospice has sufficient resources to
provide the necessary care.
To address the comment about IRC
cost outliers, in the proposed rule, we
trimmed the top and bottom 1 percent
of cost reports, which excluded some
outliers and have done so for the final
rule. We recognize that IRC does have
a wide distribution with outliers (even
after taking out the top and bottom 1
percent). While there may be some highcost outliers that affect the estimated,
average cost of IRC, we remind
stakeholders that utilization of IRC is
low, accounting for 0.3 percent of total
hospice days and it would not take
many outliers to impact the estimated
costs of providing this level of care. As
such, we would not want to make any
further exclusions to only one particular
level of care. Additionally, we note that
the rebased payment rate for IRC
excludes the 5 percent coinsurance for
each day of respite care. However,
commenters on the proposed rule stated
that most hospices do not collect this
coinsurance from beneficiaries.
Therefore, overall payment to hospices
for IRC is even further reduced in those
circumstances when hospices do not
collect this coinsurance.
Final Decision: After considering the
comments received in response to the
proposed rule and for the reasons
discussed above, we are finalizing our
proposal to rebase the payment rates for
CHC and GIP and set these rates equal
to their average FY 2019 costs per day
as shown in Table 8 of this final rule.
We are finalizing rebasing of IRC
payment rates and setting this rate 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, also as shown
in Table 8 of this final rule. Lastly, we
are finalizing a 2.72 percent reduction to
the RHC payment rates 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.
B. FY 2020 Hospice Wage Index and
Rate Update
1. Wage Index Lag Elimination
Historically, we have calculated the
hospice wage index values by using the
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prior fiscal year’s pre-floor, prereclassified hospital wage index. In an
effort to align with the Inpatient
Prospective Payment System (IPPS) and
other payment systems, in the FY 2020
hospice proposed rule (84 FR 17584),
we proposed to change the hospice
wage index methodology. Specifically,
we proposed to change from our
established policy of using the pre-floor,
pre-reclassified acute care hospital wage
index from the prior fiscal year as the
basis for the hospice wage index, and
instead to align with the same
timeframe used by the IPPS and other
payment systems. In other words, we
proposed to use the pre-floor, prereclassified hospital wage index from
the current fiscal year as the basis for
the hospice wage index. Under this
proposal, the FY 2020 hospice wage
index would be based on the FY 2020
pre-floor, pre-reclassified IPPS hospital
wage index rather than on the FY 2019
pre-floor, pre-reclassified IPPS hospital
wage index.
Using the concurrent pre-floor, prereclassified hospital wage index would
result in the most up-to-date wage data
being the basis for the hospice wage
index, increasing payment accuracy. It
would also result in more consistency
and parity in the wage index
methodology used by Medicare.
Medicare’s skilled nursing facility
(SNF), home health and inpatient
hospital prospective payment systems
already use the most current wage index
data as the basis for their wage indices.
Thus, the wage-adjusted Medicare
payments of various provider types
would be based upon wage index data
from the same timeframe. We are
considering similar policies to use the
concurrent pre-floor, pre-reclassified
hospital wage index data in other
Medicare payment systems, such as
inpatient psychiatric facilities and
inpatient rehabilitation facilities.
Overall, the impact between the FY
2020 wage index with the 1-year lag and
the proposed FY 2020 wage index
removing the 1-year lag is 0.0 percent
due to the wage index standardization
factor, which ensures that wage index
updates and revisions are implemented
in a budget-neutral manner. The
anticipated impact on Medicare hospice
payments due to the change in the wage
index methodology can be found in
Table 9 below.
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Table 9: Impact on Medicare Hospice Payments, FY 2020 Hospice Wage Index
With and Without 1 year Lag
Hospices
0.1%
0.0%
39
0.1%
-0.3%
325
-0.2%
0.1%
396
-0.3%
-0.1%
196
-0.2%
-0.1%
101
-0.3%
-0.1%
97
0.0%
0.1%
3 809
0.0%
0.0%
790
-0.2%
-0.1%
Subtotal: Non-Profit
998
-0.1%
0.0%
Subtotal: For Profit
3 039
0.1%
0.0%
Subtotal: Government
140
-0.1%
-0.2%
Subtotal: Other
422
-0.2%
0.1%
329
0.1%
-0.1%
20
-0.3%
-0.3%
45
-0.2%
0.0%
157
-0.4%
-0.2%
47
0.0%
-0.2%
74
0.0%
0.0%
0.1%
0.0%
19
0.2%
-0.3%
280
-0.2%
0.1%
239
-0.3%
0.0%
149
-0.3%
-0.1%
Based/Government
Subtotal: Freestanding Facility Type
Subtotal: Facility/HHA Based Facility Type
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2. FY 2020 Hospice Wage Index
The hospice wage index is used to
adjust payment rates for hospice
agencies 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 § 418.306(c) require each
labor market to be established using the
most current hospital wage data
available, including any changes made
by Office of Management and Budget
(OMB) to the Metropolitan Statistical
Areas (MSAs) definitions.
In the FY 2020 proposed rule (84 FR
17586), we proposed to use the current
FY’s hospital wage index data to
calculate the hospice wage index values.
For FY 2020, the proposed hospice wage
index would be based on the FY 2020
hospital pre-floor, pre-reclassified wage
index. This means that the hospital
wage data used for the hospice wage
index are not adjusted to take into
account any geographic reclassification
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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 2020, the only
CBSA without a hospital from which
hospital wage data can be derived is
25980, Hinesville-Fort Stewart, Georgia.
The FY 2020 wage index value
Hinesville-Fort Stewart, Georgia is
0.8322. Please note that CBSA 16180
Carson City, NV had no provider wage
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data for the FY 2020 proposed hospice
rule (84 FR 17586). However, this CBSA
now has provider wage data for the
updated final wage index file. The new
wage index value for CBSA 16180 is
1.0070.
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
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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 2020, we propose to continue to use
the most recent pre-floor, prereclassified 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 prereclassified 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. Pre-floor, pre-reclassified
hospital wage index values below 0.8
are adjusted by a 15 percent increase
subject to a maximum wage index value
of 0.8. 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.
We identified a slight error in the
proposed rule wage index values after
the FY 2020 Hospice Wage Index and
Payment Rate Update proposed rule was
published. A programming error caused
the data for all providers in a single
county to be included twice, which
affected the national average hourly
rate, and therefore affected nearly all
wage index values. We have changed
the programming logic so this error
cannot occur again. In addition, we
corrected the classification of one
provider in North Carolina that was
erroneously identified as being in an
urban CBSA. We also standardized our
procedures for rounding, to ensure
consistency. The correction to the
proposed rule wage index data was not
completed until after the comment
period closed June 18, 2019. This final
rule reflects the corrected and updated
wage index data. The final hospice wage
index applicable for FY 2020 (October 1,
2019 through September 30, 2020) is
available on our website at: https://
www.cms.gov/Medicare/Medicare-Fee-
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for-Service-Payment/Hospice/HospiceWage-Index.html.
We received approximately 22
comments on the FY 2020 hospice
index proposals from various
stakeholders including hospices,
national industry associations and
MedPAC. A summary of these
comments and our responses to those
comments appear below:
Comment: Several commenters
expressed support for the wage index
lag elimination. Several commenters
stated that changing the lag with the
Hospital Wage Index will help hospices
be more competitive in the labor market,
allow wages to track closer to market
shifts, and allow hospices to compete in
tight labor markets. One commenter
expressed support for CMS’ efforts to
eliminate differences between provider
types by removing the time lag. A few
commenters suggested the proposed
changes to the wage index calculations
would provide consistency with the
other Medicare payment systems. One
commenter suggested that the existing
lag makes it difficult for agencies and
companies operating in multiple states.
One commenter stated that there is
value in consistency across provider
types so that all providers can compete
in same labor pool. The commenter
further asserted that hospices may be
able to provide input to hospitals on
proposed wage index values. One
commenter expressed support for
eliminating the lag year and recognizes
the value in having wage index
consistency across provider types to
enhance the ability of all employers in
a given area to compete for staff from
the same labor pool. The commenter
further asserted that elimination of the
lag year also provides some potential for
hospices to provide input to local
hospitals when proposed wage index
values appear to undervalue the cost of
labor in a geographic area.
Response: While we appreciate the
commenters’ careful review of the
proposal and the support for the
removal of the wage index lag
elimination, we reiterate that using the
most current year’s data will most
accurately adjust payment to account for
geographic wage differences.
Comment: Several commenters
suggested utilizing a transitional year
wage index value that is a 50–50 blend
of the lag year value and FY 2020 wage
index value. One commenter suggested
that a transitional wage index would
provide some relief from substantial
negative impact that many providers
would experience by going directly to
the FY 2020 wage index. The
commenter further asserted that wage
index values for the other regions under
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38499
a blend would still exceed the values
they would have been assigned in FY
2019. One commenter recommended a
phase-in to the removal over multiple
years to minimize the disruption of the
impact on the industry. The commenter
further asserted that a phase-in is
appropriate given the significant
redistribution created by the proposed
change. One commenter stated that
while not opposed to removing the 1year lag as other types use the most
current wage index in calculating their
indices, the commenter is concerned
that the proposed rule does not provide
additional adjustments.
Response: While we appreciate
commenters’ suggestion to create a
transitional wage index that is a 50–50
blend of FY 2019 and FY 2020 wage
index values, we believe that it is
important to use the most recent data to
increase payment accuracy. We also
believe it is important to stay in
alignment with other CMS payment
systems so that there is parity and
consistency in the wage index
methodology.
Comment: A few commenters
expressed concern that removing the 1year lag would have a negative impact
on hospices. One commenter suggested
that removing the lag would have a
negative short-term impact on hospices
due to a shorter time period for
providers to plan in cases where the
wage index drops substantially. One
commenter stated that the current 1-year
lag allows hospices to plan for wage
index changes which would be far more
difficult if changes were based on the
current year’s wage index. One
commenter stated that the proposal
disadvantages providers because they
would no longer have advance warning
of wage index changes. The commenter
further asserted that providers will be
unable to plan for any significant shifts
(particularly negative shifts). One
commenter stated that elimination of
the lag year allows hospices a much
shorter period of time to adapt or adjust
their financial expectations and absorb
the impact of negative wage index
swings, particularly swings under
which the wage index value for an area
drops precipitously.
Response: We disagree that removing
the 1-year lag would have a negative
impact on hospices and we refer
commenters to Table 9 of this final rule
to see the impact with and without the
1 year wage index lag. We continue to
believe that using the most current
year’s wage index would improve
overall payment accuracy.
Final Decision: After considering the
comments we received on the
elimination of the wage index lag, we
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are finalizing the removal of the 1 year
wage index lag. We are finalizing that
we will use the current year’s wage
index to geographically wage adjust
hospice payments, so for the FY 2020
hospice per diem payment rates, these
will be geographically wage-adjusted
using the FY 2020 wage index. Using
the most current up to date information
will increase payment accuracy and
result in more consistency and parity in
the wage index methodology used by
Medicare.
We also received comments on the
hospice wage index in general and these
are summarized below, along with our
responses.
Comment: Several commenters
suggested that providers be guaranteed
a wage index value that does not drop
below the rural wage index applicable
in their state of operation.
Response: The hospice wage index
does not contain a rural floor provision.
Section 4410(a) of the Balanced Budget
Act of 1997 (Pub. L. 105–33) provides
that the area wage index applicable to
any hospital that is located in an urban
area of a state may not be less than the
area wage index applicable to hospitals
located in rural areas in that state. This
rural floor provision is specific to
hospitals. Because the hospital rural
floor applies only to hospitals, and not
to hospices, we continue to believe the
use of the pre-floor and pre-reclassified
hospital wage index results in the most
appropriate adjustment to the labor
portion of the hospice payment rates.
This position is longstanding and
consistent with other Medicare payment
systems (for example, SNF PPS, IRF
PPS, and HH PPS). The hospice floor is
applicable to all CBSAs, both rural and
urban. Pre-floor, pre-reclassified
hospital wage index values below 0.8
are adjusted by a 15 percent increase
subject to a maximum wage index value
of 0.8.
Comment: One commenter expressed
concern that hospitals currently receive
special consideration in a number of
ways, but hospices and other small
provider types are not granted the same
considerations. The commenter
suggested that creating value that is
consistent across provider types will
ensure that providers can compete in
same labor pool. One commenter
expressed concern that the current wage
index system does not provide parity to
all providers competing for the same
professionals from the same labor pool.
One commenter expressed concern that
hospitals are allowed to reclassify and
post-acute care facilities are at a
disadvantage when competing for
employees. The commenter suggested
that until CMS can create a hospice
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specific wage index methodology, CMS
should equalize rates between hospitals
and post-acute care. One commenter
expressed concern that while the same
data are used to establish the basic wage
index values applicable to most
provider types, hospitals are permitted
to seek geographic reclassification from
their assigned geographic area (thereby
receiving higher wage adjustments to
their payments).
Response: The current statute and
regulations that govern the hospice
payment system do not currently
provide a mechanism for allowing
hospices to seek geographic
reclassification. The reclassification
provision is found in section
1886(d)(10)(C)(i) of the Act, which
states, ‘‘The Board shall consider the
application of any subsection (d)
hospital requesting that the Secretary
change the hospital’s geographic
classification . . .’’ This provision is
only applicable to hospitals as defined
in section 1886(d) of the Act. In
addition, we do not believe that using
hospital reclassification data would be
appropriate, as these data are specific to
the requesting hospitals and they may or
may not apply to a given hospice.
Comment: One commenter expressed
concern that wage index values, at some
times and in some localities, are subject
to significant year-to-year swings. This
volatility has a disproportionate impact
on not-for-profit hospice programs that
have smaller operating margins and
therefore less ability to absorb large cost
swings. One commenter expressed
appreciation for adjustments in wages
that recognize the need to recruit and
contain a stable workforce for hospice.
However, the commenter also expressed
concern that for programs with tight
margins, the continued compression of
rates will result in more limited choices
of hospice providers, particularly in
rural areas and non profit hospices. One
commenter expressed concern that
hospice payment rules adopt the
hospital wage index (HWI) of the
Medicare Inpatient Hospital Prospective
Payment Systems (IPPS) which can
make Medicare payments to Hospices
volatile when there are changes in the
hospital wage costs, particularly in rural
communities. The commenter further
asserted that the HWI is threatening the
financial stability of several hospices in
Washington State and potentially across
the country, including precipitous
reductions in Medicare reimbursement
having nothing to do with local factors,
but triggered instead by organizational
changes at nearby hospitals. The
commenter suggested that the wage
index should be based on wages and
hours of labor directly tied to Medicare
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Part A services. One commenter stated
that the wage index varies for their
southern service areas, with significant
year to year swings. One commenter
expressed concern that providers
experience swings in wage index values
from year to year, and they are often
surprised by the variation in their rates.
Response: The annual changes in the
wage index reflect real variations in
costs of providing care in various
geographic locations. We utilize
efficient means to ensure and review the
accuracy of the hospital cost report data
and resulting wage index. The hospice
wage index is derived from the prefloor, pre-reclassified wage index,
which is calculated based on cost report
data from hospitals. All Inpatient
Prospective Payment System (IPPS)
hospitals must complete the wage index
survey (Worksheet S–3, Parts II and III)
as part of their Medicare cost reports.
Cost reports will be rejected if
Worksheet S–3 is not completed. In
addition, our Medicare contractors
perform desk reviews on all hospitals’
Worksheet S–3 wage data, and we run
edits on the wage data to further ensure
the accuracy and validity of the wage
data. Our review processes result in an
accurate reflection of the applicable
wages for the areas given. In addition,
we finalized a hospice wage index
standardization factor in FY 2017 (81 FR
52156) to ensure overall budget
neutrality when updating the hospice
wage index with more recent hospital
wage data. Applying a wage index
standardization factor to hospice
payments will eliminate the aggregate
effect of annual variations in hospital
wage data. Our policy of utilizing a
hospice wage index standardization
factor provides a safeguard to the
Medicare program as well as to hospices
because it will mitigate fluctuations in
the wage index by ensuring that wage
index updates and revisions are
implemented in a budget neutral
manner.
Comment: One commenter expressed
concern that hospices in Montgomery
County, Maryland are at a long-term
competitive disadvantage due to a
Medicare hospice federal payment
inequity involving core-based statistical
areas (CBSAs). The commenter
suggested that the out migration
adjustment referenced in section 505 of
the Medicare Prescription Drug,
Improvement and Modernization Act of
2003 be applied to the hospice wage
index. Section 505 introduced a hospital
wage index adjustment that is based on
commuting patterns. One commenter
stated that CMS’s and OMB’s decision
to view the current CBSA area
designation in the ‘‘aggregate’’ for a
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large geographic region like NYC
(making it a NY and New Jersey area)
fails to account for the higher costs
faced by New York providers. The
commenter also disagreed with CMS’s
assertion that OMB’s CBSA designations
are reasonable and appropriate,
reflecting the most recent available
geographic classifications, and
suggested wholesale revisions and
reform of the hospice and home health
wage index to more accurately reflect
local market conditions.
Response: We further believe that
using the most current OMB
delineations will increase the integrity
of the hospice wage index by creating a
more accurate representation of
geographic variation in wage levels. We
recognize that the OMB cautions that
the delineations should not be used to
develop and implement federal, state,
and local nonstatistical programs and
policies without full consideration of
the effects of using these delineations
for such purposes. As discussed in the
OMB Bulletin No. 03–04 (June 6, 2003),
the OMB stated that, ‘‘In cases where
there is no statutory requirement and an
agency elects to use the Metropolitan,
Micropolitan, or Combined Statistical
Area definitions in nonstatistical
programs, it is the sponsoring agency’s
responsibility to ensure that the
definitions are appropriate for such use.
When an agency is publishing for
comment a proposed regulation that
would use the definitions for a
nonstatistical purpose, the agency
should seek public comment on the
proposed use.’’ 17 While we recognize
that OMB’s geographic area delineations
are not designed specifically for use in
nonstatistical programs or for program
purposes, including the allocation of
federal funds, we continue to believe
that the OMB’s geographic area
delineations represent a useful proxy for
differentiating between labor markets
and that the geographic area
delineations are appropriate for use in
determining Medicare hospice
payments. In implementing the use of
CBSAs for hospice payment purposes in
our FY 2006 final rule (70 FR 45130),
we considered the effects of using these
delineations. We have used CBSAs for
determining hospice payments for 13
years (since FY 2006). In addition, other
provider types, such as IPPS hospital,
home health, SNF, IRF), and the ESRD
program, have used CBSAs to define
17 Bulletin 05–02, Update of Statistical Area
Definitions and Guidance on Their Uses. February
2005. https://www.whitehouse.gov/wp-content/
uploads/2017/11/bulletins_fy05_b05-02.pdf.
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their labor market areas for the last
decade.
Comment: MedPAC recommended
that the Congress repeal the existing
hospital wage index and instead
implement a market-level wage index
for use across other prospective
payment systems, including certain
post-acute care providers. MedPAC
suggested that their recommended wage
index would: Use wage data from all
employers and industry-specific
occupational weights, adjust for
geographic differences in the ratio of
benefits to wages, adjust at the county
level and smooth large differences
between counties, and include a
transition period to mitigate large
changes in wage index values. Several
commenters recommended that CMS
should develop a wage index model in
line with the system recommended by
MedPAC. One commenter questioned
whether the hospital wage index
sufficiently takes into account the labor
costs associated with the extensive
travel routinely required in the delivery
of hospice care. The commenter further
asserted that the travel costs are even
higher on a per-patient per-day basis for
hospices that serve rural populations
with large catchment areas, where
patients may be located in remote and
geographically isolated areas. The
commenter suggested that CMS should
analyze cost data to determine the
extent to which costs vary based on
geographic setting and should
incorporate findings from its analysis
into payment through appropriate
payment adjustments, in order to
protect and promote access to hospice
care for rural beneficiaries with terminal
illness.
Response: We appreciate MedPAC’s
recommendations; however, we do not
have the authority to repeal the existing
hospital wage index absent
Congressional action. We note that our
regulations at § 418.306(c) require that
each hospice’s labor market is
determined based on definitions of
Metropolitan Statistical Areas (MSAs)
issued by OMB. We will issue annually,
in the Federal Register, a hospice wage
index based on the most current
available CMS hospital wage data,
including changes to the definition of
MSAs. The urban and rural area
geographic classifications are defined in
§ 412.64(b)(1)(ii)(A) through (C). The
payment rates established by us are
adjusted by the Medicare contractor to
reflect local differences in wages
according to the revised wage data. Any
changes to the way we adjust hospice
payments to account for geographic
wage differences would have to go
through the rulemaking with comment
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38501
process. We note that in the proposed
rule, we did solicit requests for
information to explore alternate ways to
wage-adjust payments. We will review
all comments for any consideration in
future rulemaking.
To address the comment whether the
hospital wage index sufficiently takes
into account the labor costs associated
with, the extensive travel routinely
required in the delivery of hospice care,
we note that the hospital wage index
reflects the area wages and does not
factor in any travel expenses. We
recognize that hospices do incur travel
expenses and with the rebasing of the
CHC, IRC, and GIP payment rates
finalized in this rule, such expenses
were captured to more accurately align
payment with the cost of providing care.
Final Decision: After considering the
comments received in response to the
proposed rule and for the reasons
discussed above, we are finalizing our
proposal to use the current year’s prefloor, pre-reclassified hospital inpatient
wage index as the wage adjustment to
the labor portion of the hospice rates.
For FY 2020, the updated wage data are
for hospital cost reporting periods
beginning on or after October 1, 2014
and before October 1, 2015 (FY 2015
cost report data). The wage index
applicable for FY 2020 is available on
our website at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/Hospice/Hospice-WageIndex.html. The hospice wage index for
FY 2020 will be effective October 1,
2019 through September 30, 2020.
3. FY 2020 Hospice Payment Update
Percentage
Section 4441(a) of the Balanced
Budget Act of 1997 (BBA) (Pub. L. 105–
33) amended section 1814(i)(1)(C)(ii)(VI)
of the Act to establish updates to
hospice rates for FYs 1998 through
2002. Hospice rates were to be updated
by a factor equal to the inpatient
hospital market basket percentage
increase set out under section
1886(b)(3)(B)(iii) of the Act, minus 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.
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
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the 10-year moving average of changes
in annual economy-wide private
nonfarm business multifactor
productivity (MFP).
The hospice payment update
percentage for FY 2020 is based on the
estimated inpatient hospital market
basket update of 3.0 percent (based on
IHS Global Inc.’s second-quarter 2019
forecast with historical data through the
first quarter 2019). Due to the
requirements at sections
1886(b)(3)(B)(xi)(II) and 1814(i)(1)(C)(v)
of the Act, the estimated inpatient
hospital market basket update for FY
2020 of 3.0 percent must be reduced by
a MFP adjustment as mandated by
Affordable Care Act (currently estimated
to be 0.4 percentage point for FY 2020).
In effect, the hospice payment update
percentage for FY 2020 is 2.6 percent.
Currently, the labor portion of the
hospice payment rates is as follows: For
RHC, 68.71 percent; for CHC, 68.71
percent; for General Inpatient Care,
64.01 percent; and for Respite Care,
54.13 percent. The non-labor portion is
equal to 100 percent minus the labor
portion for each level of care. Therefore,
the non-labor portion of the payment
rates is as follows: For RHC, 31.29
percent; for CHC, 31.29 percent; for
General Inpatient Care, 35.99 percent;
and for Respite Care, 45.87 percent.
Beginning with cost reporting periods
starting on or after October 1, 2014,
freestanding hospice providers are
required to submit cost data using CMS
Form 1984–14 (https://www.cms.gov/
Research-Statistics-Data-and-Systems/
Downloadable-Public-Use-Files/CostReports/Hospice-2014.html). We
continue to analyze this data for
possible use in updating the labor
portion of the hospice payment rates.
Any changes to the labor portions
would be proposed in future rulemaking
and would be subject to public
comments.
While a majority of the comments
received were about the rebasing
methodology and analysis, we did
receive a few comments regarding the
hospice payment update percentage.
Our responses to those comments are
below:
Comment: MedPAC recognizes that
CMS is required by statute to propose an
increase to the FY 2020 base rates of 2.7
percent, however they noted that in
their 2019 report to Congress, they
recommended that Congress reduce the
aggregate level of payment to hospices
for FY 2020 by 2 percent.
Response: We appreciate the
comment, however, we do not have the
statutory authority to use an alternate
methodology to determine the amount
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of the annual payment updates to
hospice payment rates.
Comment: One commenter stated that
for organizations that rely on
contractual arrangements to meet their
inpatient care requirements, the budget
neutrality component that lowers the
RHC payment rates effectively turns the
rebasing proposal into a rate cut even
after the proposed 2.7 percent payment
update.
Response: We note that we are
statutorily required, as set forth in
section 1814(i)(1)(C)(ii)(VII) of the Act,
to update the hospice rates annually by
the inpatient market basket percentage
increase for that FY.
Final Decision: We are finalizing the
hospice payment update percentage for
FY 2020 as proposed. Based on IHS
Global, Inc.’s updated forecast of the
inpatient hospital market basket update
and the multifactor productivity
adjustment, the hospice payment update
percentage for FY 2020 is equal to 2.6
percent for hospices that submit the
required quality data and 0.6 percent
(FY 2020 hospice payment update of 2.6
percent minus 2 percentage points) for
hospices that do not submit the required
data.
4. FY 2020 Rebased Hospice Payment
Rates
There are four hospice payment
categories, all of which are
distinguished by the location and
intensity of the 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 provided to treat
symptoms that cannot be managed in
another setting.
As discussed in the FY 2016 Hospice
Wage Index and Rate Update final rule
(80 FR 47172), we implemented two
different RHC payment rates, one RHC
rate for the first 60 days and a second
RHC rate for days 61 and beyond. In
addition, in that final rule, we
implemented a Service Intensity Add-on
(SIA) payment for RHC when direct
patient care is provided by a 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
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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 SIA budget neutrality
factor.
As discussed in the FY 2016 Hospice
Wage Index and Rate Update final rule
(80 FR 47177), we will continue to make
the SIA payments budget neutral
through an annual determination of the
SIA budget neutrality factor (SBNF),
which will then be applied to the RHC
payment rates. The SBNF will be
calculated for each FY using the most
current and complete utilization data
available at the time of rulemaking. For
FY 2020, this calculation reflects the
proposed increase in the hourly rate for
CHC as a result of rebasing, discussed in
section III.A.3 of this final rule.
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. In order to
calculate the wage index
standardization factor, we simulate total
payments using the proposed FY 2020
hospice wage index (no lag) and
compare it to our simulation of total
payments using the FY 2019 hospice
wage index. By dividing payments for
each level of care using the FY 2020
wage index (no lag) by payments for
each level of care using the FY 2019
wage index, we obtain a wage index
standardization factor for each level of
care (the first 60 RHC days and RHC
days after day 60 and, CHC, IRC, and
GIP). The wage index standardization
factors for each level of care are shown
in the Tables 10 and 12 below.
As discussed in section III.A.3, we are
finalizing rebasing of the per diem
payment rates for CHC, IRC, and GIP
levels of care. As mentioned above and
outlined in the Affordable Care Act,
hospice payment reform must be done
in a budget-neutral manner. In order to
rebase the per diem payment amounts
for CHC, IRC, and GIP in a budgetneutral manner, as described in section
III.A.3, increases to the CHC, IRC, and
GIP per diem payment amounts will be
offset by corresponding decreases to the
RHC per diem payment amounts to
maintain overall budget neutrality.
The FY 2020 RHC per diem payment
rates are the FY 2019 rebased payment
rates, reduced by a budget neutrality
factor as a result of rebasing of the CHC,
IRC, and GIP payment amounts,
adjusted by the SIA budget neutrality
factor, adjusted by the wage index
standardization factor, and increased by
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2019 rebased payment rates, adjusted by
the wage index standardization factor
and increased by the hospice payment
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 final rule (76
FR 47320 through 47324), we
implemented a Hospice Quality
Reporting Program as required by
section 3004 of the Affordable Care Act.
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
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update percentage (2.6 percent) as
shown in Table 11.
BILLING CODE 4120–01–P
data submission requirements with
respect to that FY. The FY 2020 rates for
hospices that do not submit the required
quality data is updated by the FY 2020
hospice payment update percentage of
2.6 percent minus 2 percentage points.
These rates are shown in Tables 12 and
13.
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ER06AU19.032</GPH>
the 2.6 percent hospice payment update
percentage as shown in Table 10. The
FY 2020 rebased CHC, IRC, and GIP per
diem payment rates are equal to the FY
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Table 12: FY 2020 Hospice RHC Payment Rates for Hospices That DO NOT
Submit the Required Quality Data
Code
Description
Routine
Home Care
(days 1-60)
Routine
Home Care
(days 61 +)
651
651
FY2019
Rebased
Payment
Rates*
SIABudget
Neutrality
Factor
Wage Index
Standardization
Factor**
FY2020
Hospice
Payment
Update of
2.6%
minus 2
percentag
e points=
+0.6%
$190.91
X 0.9924
X 1.0006
X 1.006
$190.71
$150.02
X 0.9982
X 1.0005
X 1.006
$150.72
FY2020
Payment
Rates
* FY 2019 RHC payment rates adjusted to rebase CHC, IRC, and GIP in the following manner: FY 2019
RHC rate for days 1-60 = $196.25 * 0.9728 = $190.91. FY 2019 RHC rate for days 61+ = $154.21 *
0.9728 = $150.02.
**Transition from FY 2019 Wage Index to FY 2020 Wage Index without 1-Year Lag.
656
Inpatient Respite
Care
General Inpatient
Care
$437.86
X 1.0019
X 1.006
$441.32
$992.99
X 1.0024
X 1.006
$1,001.35
*Transition from FY 2019 Wage Index to FY 2020 Wage Index without 1-Year Lag.
BILLING CODE 4120–01–C
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655
ER06AU19.034</GPH>
Table 13: FY 2020 Hospice CHC, IRC, and GIP Payment Rates for Hospices That
DO NOT Submit the Required Quality Data
FY2020
Hospice
Payment
FY2019
Wage Index
Update of
FY 2020
2.6%
Code
Description
Rebased
Standardization
Payment
Payment Rates
Factor*
minus 2
Rates
percentage
points=
+0.6%
Continuous Home
$1,368.42
Care
$1,363.26
Full Rate = 24
($57.02=
652
($56.80=hourly
X .9978
X 1.006
hourly rate)
hours of care
rate)
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Final Decision: We are finalizing the
FY 2020 payment rates in accordance
with statutorily mandated requirements.
5. Hospice Cap Amount for FY 2020
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, 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. The
hospice cap amount for the FY 2020 cap
year will be $29,964.78, which is equal
to the FY 2019 cap amount ($29,205.44)
updated by the FY 2020 hospice
payment update percentage of 2.6
percent. A summary of the comments
we received regarding the hospice cap
amount and our responses to those
comments appear below:
Comment: A few commenters
suggested that geographical differences
should be considered when calculating
the annual cap amounts. One
commenter stated that the cap
discriminates against providers with
higher daily reimbursement rates
because the cap is applied on a national
basis, without regard to the geographical
location of the patient. Another
commenter suggested adjusting the
hospice cap amounts for wage index in
the same manner that the per diem
payments are adjusted. This commenter
further asserted that wage adjusting the
payments and not the cap has the effect
of reversing the wage index, since the
caps will be reached (and exceeded)
more quickly in high wage labor
markets than in low wage labor markets.
The commenter suggested that this
creates an unintended penalty or benefit
to a hospice based on where it is
located, not on the quality or efficiency
of the care provided.
Response: We appreciate the
commenters’ suggestion that we
consider geographical differences when
calculating the annual cap amount.
However, the restriction set forth in
section 1814(i)(2)(B) of the Act, as
amended by section 3(d) of the IMPACT
Act, does not give us discretion to adjust
the cap amount.
Comment: One commenter
recommended that funds allocated for
the cap amount increase instead be
applied to reducing the cut to the RHC.
The commenter suggested that holding
the cap at its current level would also
likely hold down margins from highmargin hospices. A few commenters
also suggested that lowering the
aggregate cap amount for all hospices by
at least 10 percent from the FY 2019
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amount would be a better way to control
hospice spending.
Response: We appreciate the
commenter’s suggestion that we lower
the annual cap amount. However, the
restriction set forth in section
1814(i)(2)(B) of the Act, as amended by
section 3(d) of the IMPACT Act, does
not give us discretion to adjust the cap
amount.
Comment: One commenter suggested
the cap amount be used to explore
questionable practices by hospices.
Specifically, this commenter was
referring to hospices that come up to the
cap limit, but do not exceed it, because
they are deliberately discharging
beneficiaries solely to avoid any
overpayments. This commenter also
stated that CMS should further
investigate those hospices that routinely
exceed the cap limit to see if there is any
aberrant patterns of care that may
warrant targeted program integrity
efforts. The commenter stated that CMS
could use its program integrity authority
using claims and quality data to address
this issue with little additional burden
to hospice agencies.
Response: We appreciate the
commenter’s suggestion to consider
looking into the practices of hospices
that regularly reach or exceed the
annual aggregate cap amount to target
further program integrity investigations.
We remind stakeholders that under the
Medicare hospice benefit, § 418.26(a)(1),
(2), and (3), there are limited reasons
why a hospice can discharge a
beneficiary alive: The beneficiary
decides to revoke the hospice benefit;
the beneficiary transfers to another
hospice; or, the beneficiary is no longer
terminally ill. Hospice care is provided
to beneficiaries who are nearing the end
of life and provides comfort for the
dying, neither hastening death nor
prolonging life by attempting to cure the
terminal illness. Discharging a
beneficiary solely to avoid exceeding
the cap limit is in violation of the
regulations at § 418.26 and may cause
undue distress and potential harm to
terminally ill patients who would have
to seek care outside of the hospice
benefit. We will closely monitor this
issue and address any identified
concerns, if necessary.
Final Decision: We are finalizing the
update to the hospice cap in accordance
with statutorily mandated requirements.
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38505
C. Election Statement Content
Modifications and Addendum To
Provide Greater Coverage Transparency
and Safeguard Patient Rights
1. Background
In the FY 2020 hospice proposed rule
(84 FR 17589), we provided background
on the holistic nature of the services
provided under the Medicare hospice
benefit, as well as the current statutory
and regulatory requirements for care
planning and patient rights. We stated
that in order to make an informed
choice about whether to receive hospice
care, the patient, family, and caregiver
must have an understanding of what
services are going to be provided by the
hospice and that, because there is no
longer a reasonable expectation for a
cure, care should now focus on comfort
and quality of life. The services covered
under the Medicare hospice benefit are
comprehensive such that, upon election,
the individual waives all rights to
Medicare payment for services related to
the treatment of the individual’s
condition with respect to which a
diagnosis of terminal illness has been
made, except when provided by the
designated hospice or attending
physician. Because of the significance of
this decision, the terminally ill
individual must elect hospice care in
order to receive services under the
Medicare hospice benefit. Since we first
implemented the Medicare hospice
benefit in 1983, it has been our general
view that the waiver required by law
requires hospices to provide virtually all
the care that is needed by terminally ill
patients (48 FR 56010).
Additionally, in the FY 2015
proposed rule (79 FR 26555), we
described the eligibility, certification,
and election requirements for receipt of
hospice services as set forth at 42 CFR
418.20, 418.22 and 418.24. We also
emphasized that in reaching a decision
to certify that the patient is terminally
ill, the hospice medical director must
consider the principal diagnosis of the
patient, all other health conditions,
whether related or unrelated to the
terminal condition, and all clinically
relevant information supporting all
diagnoses. The clinical information and
other documentation that support the
medical prognosis must accompany the
written certification and must be filed in
the individuals’ hospice medical record
in accordance with the regulations at
§ 418.22(b)(2) and the hospice CoPs at
§ 418.102(b). Once a beneficiary is
certified as terminally ill, he or she
becomes eligible to elect hospice care
under the Medicare hospice benefit.
Because the receipt of hospice
services under the Medicare hospice
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benefit is dependent upon the eligible
beneficiary electing to receive hospice
care, the regulations at § 418.24 provide
the requirements of the hospice election
statement. The election statement must
include the identification of the
designated hospice and attending
physician (if any); the individual’s or
representative’s acknowledgement that
he or she has been given a full
understanding of the palliative rather
than curative nature of hospice care;
and the individual’s or representative’s
acknowledgement that the individual
waives the right to Medicare payment
for services related to the terminal
illness and related conditions, except
when provided by the designated
hospice or attending physician. Services
unrelated to the terminal illness and
related conditions remain eligible for
Medicare coverage and payment outside
of the hospice benefit.
Once the beneficiary has elected
hospice care, the hospice conducts an
initial assessment visit in advance of
furnishing care. During this visit, the
hospice must provide the patient or
representative with a spoken and
written notice of the patient’s rights and
responsibilities as required by the CoPs
at § 418.52. Our rules state that the
beneficiary has the right to be involved
in developing his or her hospice plan of
care; receive information about the
services covered under the hospice
benefit; and receive information about
the scope of services that the hospice
will provide and specific limitations on
those services. The hospice program
must assure the patient that its staff will
protect patients’ rights and will involve
patients in decisions about their care,
treatment and services.18 Likewise, the
regulations at § 476.78(b)(3) state that
providers must inform Medicare
beneficiaries at the time of admission, in
writing, that the care for which
Medicare payment is sought will be
subject to Quality Improvement
Organization (QIO) review.
Additionally, the hospice CoPs at
§ 418.54(c) provide the content
requirements for the initial and
comprehensive assessments used to
identify patient, family, and caregiver
needs for physical, emotional,
psychosocial, and spiritual care. As part
of the comprehensive assessment, the
hospice is required to assess the patient
for complications and risk factors,
which can affect care planning. The
needs identified in these assessments
drive the development and revisions of
an individualized written plan of care
for each patient as required by the CoPs
at § 418.56. Collectively, the
interdisciplinary team (IDG), in
consultation with the patient’s attending
physician (if any), makes care plan
decisions for each patient to ensure that
each care plan is individualized to meet
the unique needs of each hospice
beneficiary. The plan of care also must
reflect patient, family, and caregiver
preferences, goals, and interventions
based on the problems identified in the
initial, comprehensive, and updated
comprehensive assessments. The plan of
care must include all services necessary
for the palliation and management of
the terminal illness and related
conditions and the CoPs at § 418.56(c)
detail the plan of care content
requirements. However, though
hospices are responsible for providing
all services needed for palliation and
management of the terminal illness and
related conditions, the 2008 Hospice
Conditions of Participation final rule (73
FR 32088, June 5, 2008) states that while
needs unrelated to the terminal illness
and related conditions are not the
responsibility of the hospice, the
hospice may choose to furnish services
for those needs regardless of
responsibility (73 FR 32114). If a
hospice does not choose to furnish
services for those needs unrelated to the
terminal illness and related conditions,
the hospice is to document such needs
and communicate and coordinate with
those health care providers who are
identified as caring for the unrelated
needs, as set out at § 418.56(e)(5). To
ensure comprehensive and coordinated
care, at § 418.56(e) we require hospices
to have a communication system that
allows for the exchange of information
with other non-hospice health care
providers who are furnishing care
unrelated to the terminal illness and
related conditions.
We also require hospices to designate
a registered nurse (RN) who is a member
of the IDG to coordinate implementation
of the comprehensive plan of care. The
designated RN must assure that
coordination of care and continuous
assessment of patient, family, and
caregiver needs occur among staff
providing services to the patient, family,
and caregiver so that all IDG members
are kept informed of the patient/family’s
status.19 The goal of a coordinated
communication process and a
designated nurse coordinator is to
18 State Operations Manual Appendix M—
Guidance to Surveyors: Hospice. https://
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/downloads/som107ap_m_
hospice.pdf.
19 State Operations Manual Appendix M—
Guidance to Surveyors: Hospice. https://
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/downloads/som107ap_m_
hospice.pdf.
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adequately ensure that each patient’s
hospice care is coordinated both within
the hospice and with other health care
providers.
2. Services Unrelated to the Terminal
Illness and Related Conditions
In the FY 2020 hospice proposed rule,
we reiterated our long-standing position
that services unrelated to the terminal
illness and related conditions should be
exceptional, unusual and rare given the
comprehensive nature of the services
covered under the Medicare hospice
benefit as articulated upon the
implementation of the benefit (48 FR
56008, 56010, December 16, 1983). To
the extent that individuals receive
services outside of the Medicare hospice
benefit during a hospice election,
Medicare coverage is determined by
whether or not the services are for the
treatment of a condition completely
unrelated to the individual’s terminal
illness and related conditions (48 FR
38146, 38148, August 22, 1983). In the
FY 2020 hospice proposed rule, we
detailed numerous anecdotal reports
from beneficiaries, families, the
Medicare Ombudsman’s office, and nonhospice providers where hospice
patients were obtaining needed items,
services, and drugs outside of the
hospice benefit because they had been
told that hospice would not cover these
items, services, and drugs, as the
hospice had determined that they were
unrelated to the terminal illness and
related conditions. Many of these
anecdotal reports state that the
beneficiaries and families believed that
these items, services, and drugs were
related to the terminal illness and
related conditions and thought that they
should have been provided by the
hospice. The beneficiaries and/or the
families stated that they did not know
they would have to seek care outside of
the hospice benefit for these conditions
because the hospice did not tell them
these items, services, and drugs would
not be furnished by the hospice until
the patient needed them. We remind
stakeholders that the Medicare
Beneficiary Ombudsman (MBO) is
charged with supporting CMS’ customer
service and administration efforts by
receiving and responding to beneficiary
and other stakeholder inquiries and
complaints, working with partners to
provide outreach and education to
beneficiaries, and providing
recommendations for improving the
administration of Medicare. The MBO
also provides an annual report to
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Congress that are posted on the MBO
website.20
In accordance with the hospice CoPs
at § 418.56(e)(5), and in alignment with
continuity of care principles,21 the
ongoing sharing of information with
other non-hospice healthcare providers
and suppliers furnishing services
unrelated to the terminal illness and
related conditions is necessary to ensure
coordination of services and to meet the
patient, family, and caregiver needs.
The coordination requirements include
that the hospice must develop and
maintain a system of communication
and integration amongst all providers
furnishing care to the terminally ill
patient. This communication helps to
minimize fragmented care and to
improve quality of life. Part of that
communication process is the clear
identification of what the related and
unrelated conditions are and who is
responsible for providing reasonable
and necessary services for those
conditions. As is the preferred practice
for care coordination and
communication,22 both hospice and
non-hospice providers typically
document these discussions, which then
becomes part of the patient’s medical
record with each provider. Accordingly,
all Medicare providers and suppliers
must be able to provide medical
documentation to support payment for
services billed (sections 1815(a) and
1833(e) of the Act). For non-hospice
providers or suppliers billing Medicare
for services received by hospice
beneficiaries unrelated to their terminal
illness and related conditions, this
includes being able to provide
documentation from the hospice listing
the conditions (and thus items, drugs,
and services) the hospice determined to
be unrelated and documented as such
on the hospice plan of care.
While hospices are required by the
CoPs to have a system of
communication with non-hospice
providers to furnish such information,
we have heard anecdotally from nonhospice providers stating that they are
unable to reach or do not receive return
20 Medicare Beneficiary Ombudsman (MBO).
https://www.cms.gov/Center/Special-Topic/
Ombudsman/Medicare-Beneficiary-OmbudsmanHome.html.
21 Uijena,A., Schersa,H., Schellevisb, F., van den
Bosch,W. How unique is continuity of care? A
review of continuity and related concepts. Family
Practice 2012; 29:264–271 doi:10.1093/fampra/
cmr104.
22 National Quality Forum (NQF), Preferred
Practices and Performance Measures for Measuring
and Reporting Care Coordination: A Consensus
Report, Washington, DC: NQF; 2010. https://
www.qualityforum.org/Publications/2010/10/
Preferred_Practices_and_Performance_Measures_
for_Measuring_and_Reporting_Care_
Coordination.aspx.
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calls from the hospice to discuss the
hospice beneficiary’s coordination of
services that the hospice has determined
unrelated to his or her terminal illness
and related condition(s). Likewise, we
have also received anecdotal reports
from hospices who state they were
unaware that patients had received care
from non-hospice providers. In these
reports, the hospice would first learn of
this outside care when non-hospice
providers would contact the hospice
seeking reimbursement. If this care was
related to the terminal illness and
related conditions and the hospice did
not make arrangements for such care,
the beneficiary would be liable for the
costs of receiving that care.
Additionally, if non-hospice providers
bill Medicare for services that
potentially should have been the
coverage responsibility of hospice,
Medicare could be making duplicative
payments for care related to the terminal
illness and related conditions, as
described in the June, 2012 OIG report 23
identifying situations where Medicare
may have been paying twice for
prescription drugs for hospice
beneficiaries.
In previous years’ hospice proposed
rules, we have included data on nonhospice expenditures for beneficiaries
under a hospice election. These total
non-hospice expenditures include
beneficiary cost-sharing amounts. For
Parts A and B, the beneficiary costsharing amounts in FY 2017 totaled
approximately $138 million and for Part
D, the beneficiary cost-sharing totaled
approximately $68.6 million (83 FR
20946 through 20947). We believe that
this is a substantial financial burden
being placed on terminally ill
individuals for services that potentially
should have been covered by hospice.
This suggests that hospice beneficiaries
may be incurring unnecessary financial
burden as they are having to seek out
and pay for items and services for pain
and symptom relief—services that
hospice should be furnishing and
covering.
However, in spite of the data provided
and reiteration of longstanding policy
regarding the comprehensive nature of
hospice services covered under
Medicare, we continue to have concerns
that these decisions as to what hospices
will cover and not cover are based on
a more narrow view of the overall
condition of the individual, as is
evidenced by the non-trivial amount of
items, services, and drugs for potentially
23 Medicare
Could Be Paying Twice for
Prescription Drugs for Beneficiaries in Hospice (A–
06–10–00059). June 28, 2012. https://oig.hhs.gov/
oas/reports/region6/61000059.pdf.
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related conditions provided by nonhospice providers to beneficiaries under
a hospice election.
3. Election Statement Content
Modifications and Addendum To
Provide Greater Coverage Transparency
and Safeguard Patient Rights
The regulations, as described
previously, require the hospice to
include all services needed for the
palliation and management of the
terminal illness and related conditions
on the individualized hospice plan of
care, and the plan of care should also
identify the conditions or symptoms
that the hospice determines to be
‘‘unrelated’’ so hospices can provide
ongoing sharing of information with
other non-hospice healthcare providers
who may be furnishing services
unrelated to the terminal illness and
related conditions.24 Although hospices
are required to educate each patient and
the primary caregiver(s) on the services
identified on the plan of care and
document the patient’s or
representative’s level of understanding,
involvement, and agreement with the
plan of care, the incidence of anecdotal
reports and the amount and nature of
the non-hospice services being billed to
Medicare outside of the hospice benefit
suggests that hospice beneficiaries may
not be fully informed, at the time of
admission or throughout the hospice
election, of the items, services, and
drugs the hospice has determined to be
unrelated to their terminal illness and
related conditions. We believe this is
necessary information for patients and
their families to make informed care
decisions and to anticipate any financial
liability associated with needed items,
services, and drugs not provided under
the Medicare hospice benefit. Not
having this information may result in a
lack of coverage transparency and where
beneficiaries are unaware of their
financial liability while under a hospice
election for those items, services, and
drugs the hospice has determined to be
unrelated to their terminal prognosis.
Therefore, in the FY 2020 hospice
proposed rule (84 FR 17570), we
proposed to modify the hospice election
statement content requirements at
§ 418.24(b) to increase coverage
transparency for patients under a
hospice election. In addition to the
existing election statement content
requirements at § 418.24(b), we
proposed that hospices also would be
24 State Operations Manual Appendix M—
Guidance to Surveyors: Hospice https://
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/downloads/som107ap_m_
hospice.pdf. (L-Tag 538)
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required to include the following on the
election statement:
• Information about the holistic,
comprehensive nature of the Medicare
hospice benefit.
• A statement that, although it would
be rare, there could be some necessary
items, drugs, or services that will not be
covered by the hospice because the
hospice has determined that these
items, drugs, or services are to treat a
condition that is unrelated to the
terminal illness and related conditions.
• Information about beneficiary costsharing for hospice services.
• Notification of the beneficiary’s (or
representative’s) right to request an
election statement addendum that
includes a written list and a rationale
for the conditions, items, drugs, or
services that the hospice has determined
to be unrelated to the terminal illness
and related conditions and that
immediate advocacy is available
through the BFCC–QIO if the
beneficiary (or representative) disagrees
with the hospice’s determination.
Likewise, we proposed to make the
corresponding regulations text changes
at § 418.24(b).
Additionally, we proposed a new
requirement where hospices would be
required, but only upon request, to
provide to the beneficiary (or
representative) an election statement
addendum (hereafter called ‘‘the
addendum’’) with a list and rationale for
the conditions items, services, and
drugs that the hospice has determined
as unrelated to the terminal illness and
related conditions. Similarly, we
proposed that hospices would be
required to provide the addendum,
upon request, to other non-hospice
providers that are treating such
conditions, and Medicare contractors
who request such information. We
proposed that if the addendum is
requested at the time of hospice
election, the hospice must provide this
information, in writing, to the
individual (or representative) within 48
hours of the request. Furthermore, we
proposed that if this addendum is
requested during the course of hospice
care, the hospice must provide this
information, in writing, immediately to
the requesting individual (or
representative), non-hospice provider,
or Medicare contractor, as this
information should be readily available
in the beneficiary’s hospice medical
record. During the course of hospice
care, if there are changes to the plan of
care that result in a determination that
a new illness or condition has arisen,
we proposed that hospices would be
required to issue an updated addendum
to the patient (or representative)
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reflecting whether or not items, services
and supplies related to the new illness
or condition will be provided by the
hospice. We also proposed that hospices
would be exempt from completing this
addendum if the beneficiary died within
48 hours of the election date of hospice
care.
The purpose of the proposed
addendum is to inform beneficiaries and
their families of hospice-determined
non-covered conditions, items, services,
and drugs to provide full coverage
transparency to hospice patients and
their families to assist in making
treatment decisions. Likewise, the
addendum would help facilitate
communication and benefit
coordination between hospices and nonhospice providers.
We proposed that hospices would
develop and design the addendum to
meet their needs, similar to how
hospices develop their own hospice
election statement. We proposed the
addendum would be titled ‘‘Patient
Notification of Hospice Non-Covered
Items, Services, and Drugs.’’ We
proposed that the addendum would
include the following information:
1. Name of the hospice;
2. Beneficiary’s name and hospice
medical record identifier;
3. Identification of the beneficiary’s
terminal illness and related conditions;
4. 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;
5. 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 would be
accompanied by a general statement that
the decision as to whether or not
conditions, items, services, and drugs is
related is made for each patient and that
the beneficiary should share this
clinical explanation with other health
care providers from which they seek
services unrelated to their terminal
illness and related conditions;
6. References to any relevant clinical
practice, policy, or coverage guidelines.
7. Information on the following
domains:
a. Purpose of Addendum.
b. Right to Immediate Advocacy.
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8. Name and signature of 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.
We proposed to add the election
statement modifications and the
election statement addendum content
requirements to the regulations at
§ 418.24.
Finally, we proposed that the signed
addendum (and any signed updates)
would be a new condition for payment.
We also stated that this would not mean
that in order to meet this condition for
payment that the beneficiary (or
representative), or non-hospice provider
must agree with the hospice’s
determination. For purposes of this
condition for payment, we proposed
that the signed addendum is only
acknowledgement of the beneficiary’s
(or representative’s) receipt of the
addendum (or its updates) and this
payment requirement would be met if
there was a signed addendum (and any
signed updates) in the requesting
beneficiary’s medical record with the
hospice. This addendum would not be
required to be submitted with any
hospice claims. Likewise, the hospice
beneficiary (or representative) would
not have to separately consent to the
release of this information to nonhospice providers furnishing services
for unrelated conditions as the Health
Insurance Portability and
Accountability Act of 1996 (HIPAA)
Privacy Rule allows those doctors,
nurses, hospitals, laboratory
technicians, and other health care
providers that are covered entities to use
or disclose protected health
information, such as X-rays, laboratory
and pathology reports, diagnoses, and
other medical information for treatment
purposes without the patient’s express
authorization. This includes sharing the
information to consult with other
providers, including providers who are
not covered entities, to treat a different
patient, or to refer the patient (45 CFR
164.506).
Ninety-two unique stakeholders
submitted their comments on the
proposed modifications to the election
statement content requirements and the
proposed election statement addendum.
These stakeholders included hospices,
national and state industry associations,
individual commenters, as well as the
Medicare Payment Advisory
Commission (MedPAC).
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Election Statement Modifications
While many commenters supported
the modifications to the election
statement content requirements, several
had concerns regarding these changes.
These comments, along with our
responses, are summarized below.
Comment: Several commenters,
including MedPAC, supported the
proposal to modify the hospice election
statement content requirements to
increase coverage transparency for
patients under a hospice election.
Commenters agreed with CMS’ efforts to
educate and empower patients to make
informed decisions. They reiterated the
importance of beneficiaries and their
families understanding what is covered
by the hospice benefit and being
informed of the resources available to
appeal decisions by hospice providers if
they have concerns or disagree with
coverage determinations made by their
hospice provider.
Response: We appreciate these
comments and thank commenters for
their thoughtful review and support of
our efforts to provide patients with
complete information regarding
payment and cost-sharing obligations as
well as implications for other providers.
Comment: One commenter disagreed
with the proposal that the election
statement include information on
individual cost-sharing for hospice
services. This commenter stated that
hospices are permitted, but not
required, to impose small coinsurance
payments for hospice drugs and
inpatient respite care, and that most
hospices do not charge patients for this
coinsurance. This commenter remarked
that including this information on the
election statement would be confusing
for patients and burdensome for
hospices to have to explain. Other
commenters suggested that additional
language should be added to the
election statement to indicate that
Medicare continues to pay for any such
unrelated items under traditional
Medicare benefits.
Response: To provide full
transparency regarding hospice coverage
under the Medicare hospice benefit, we
believe that the election statement
should include information that there
may be individual cost-sharing for
certain hospice services while under a
hospice election. We did not propose
specific language requirements for
communicating information on costsharing for hospice services and we
believe this information can be
communicated simply and in a
straightforward fashion to beneficiaries.
For example, a general statement saying
that while under a hospice election
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there may be cost-sharing for hospice
medications and inpatient respite
allows beneficiaries to ask the hospice
for more information on such costsharing, if needed. Likewise, if a
hospice does not charge any
coinsurance for hospice drugs of
inpatient respite care, it could include
such a statement on their election
statements.
As for the suggestion that CMS should
require hospices to indicate that there is
coverage for unrelated items, services,
and drugs on the election statement
itself, hospices can add whatever
language they feel best communicates
information to the beneficiary about
coverage under the Medicare hospice
benefit as long as such information is in
accordance with the hospice
regulations. This could include a
disclaimer statement that unrelated
items, services, and drugs may be
covered through other Medicare
benefits. We note that in 2016, we
provided a model election statement as
part of a MLN Matters® article
(SE1631) 25 in which there is a statement
that reads: ‘‘I understand that services
not related to my terminal illness or
related conditions will continue to be
eligible for coverage by Medicare.’’
Hospices could adopt such language on
the election statement to best meet their
needs and to adequately communicate
this information to beneficiaries and
their families at the time of hospice
election. One industry commenter
stated that many hospices already use
this model election statement and
simple modifications to this election
statement could be easily achieved to
satisfy the proposed changes to the
election statement content
requirements.
Election Statement Addendum
Comment: Several commenters stated
that the time of hospice election is an
overwhelming and confusing time for
individuals and their families.
Commenters remarked that the
addendum might have the unintended
consequence of further overwhelming
and frightening patients and their
families, giving the impression that
patients would not be given the
symptom-controlling medications that
they need. Some commenters believe
that the addendum may delay access to
needed services because of the time it
would take to make these
determinations and consult with the
25 Sample Hospice Election Statement. MLN
Matters® Number: SE1631 Revised. December 2016.
https://www.cms.gov/Outreach-and-Education/
Medicare-Learning-Network-MLN/
MLNMattersArticles/Downloads/SE1631.pdf.
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38509
IDG and could potentially deter
individuals from electing the benefit.
Response: The services covered under
the Medicare hospice benefit are
comprehensive such that, upon election,
the individual waives all rights to
Medicare payment for services related to
the treatment of the individual’s
condition with respect to which a
diagnosis of terminal illness has been
made, except when provided by the
designated hospice or attending
physician. Since we first implemented
the Medicare hospice benefit in 1983, it
has been our general view that the
waiver required by law requires
hospices to provide virtually all the care
that is needed for terminally ill patients
(48 FR 56010). As such, we understand
that the decision to elect hospice is not
one that is taken lightly and it is
because of the significance of this
decision that we believe individuals and
their families need to have full
disclosure and coverage transparency
regarding the services provided and not
provided by the hospice as they
approach the end of life.
The hospice CoPs at § 418.52(a)
require that during the initial
assessment visit, in advance of
furnishing care, the hospice must
provide the patient or representative
with verbal (meaning spoken) and
written notice of the patient’s rights and
responsibilities in a language and
manner that the patient understands.
Furthermore, hospices are to inform the
beneficiary of the services covered
under the Medicare hospice benefit, as
well as the scope of such services. The
intent of this standard was to ensure
that patients were aware of their
potential out-of-pocket costs for hospice
care, such as co-payments, so that they
would not be surprised by financial
concerns at this stressful time (73 FR
32097). Therefore, hospices are already
tasked with providing detailed
information on hospice services and
limitations to those services to the
patient upon election of the benefit. We
believe that the addendum further
complements these requirements by
ensuring that the hospice informs them
of any items, services, or drugs which
the terminally ill individual would have
to seek outside of the benefit.
Because of the longstanding
requirements to communicate the
breadth of the Medicare hospice benefit
to individuals and their families prior to
the provision of any hospice services,
we do not believe that providing full
coverage transparency at the time of
hospice election would generally deter
or unnecessarily overwhelm individuals
from electing hospice, thereby limiting
access to such services. Terminally ill
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individuals and their families are
making decisions for how the individual
chooses to live out their remaining days
at the end of life.
As the hospice model of care is for
palliation and comfort, rather than for a
cure, the Medicare hospice benefit must
be elected by the terminally ill
individual who is agreeing to this model
of care, as well as waiving the right to
Medicare payment for items, services
and drugs for the treatment of the
terminal illness and related conditions.
The purpose of the addendum as noted
in the proposed and this final rule is to
provide for coverage transparency to
help ensure individuals are fully
informed when making such a decision.
If, after receiving information about all
of the items, services, and drugs the
hospice will and will not cover, the
individual chooses not to elect the
benefit (or to discontinue the benefit),
then the individual has made an
informed choice based on his or her
goals and preferences of care. Hospices
should be able to communicate this
information in a clear, thoughtful, and
compassionate manner in accordance
with the spirit of hospice philosophy
where the individual and the family are
the center of the care team. In doing so,
the hospice will have made every effort
to ensure patients are aware of all
services covered and not covered by the
hospice. We believe that an informed
beneficiary will make the most
appropriate choice to meet his or her
needs and it is the hospice’s
responsibility to provide this
information to support and promote
beneficiary choice and access to needed
services.
Comment: A few commenters
disagreed with providing a written
clinical reason for why certain
diagnoses/conditions, items, services,
and drugs are not covered to
beneficiaries (or their representatives)
and non-hospice providers. These
commenters stated that hospices may be
inconsistent with using evidence-based
rationale or may use different sources to
support their determinations. Others
voiced concerns over disagreements
between non-hospice providers and
hospice providers on the unrelated
determinations and stated this may
result in debate regarding the hospice
physician’s reasoning. Commenters
stated that varying clinical opinions
between hospice and non-hospice
providers may delay the provision of
items, services, and drugs.
Response: We believe it is not only
important to inform beneficiaries of
what items, services, and drugs the
hospice will not be covering because
they have determined these items,
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services, and drugs to be unrelated to
the terminal illness and related
conditions, but why the hospice has
made this determination. As noted
previously, beneficiaries are making a
choice to elect hospice care and we
believe it to be of utmost importance to
promote transparency, autonomy, and
patient choice, and patients need to
understand the rationale for decisions
being made that affect their care. While
we proposed that hospices would
provide a clinical rationale as part of the
proposed addendum, we did not
propose requirements as to specific
sources of such information as we
believe that hospices would use
evidence-based information to
communicate the rationale to patients in
a manner in which they understand.
There is a large quantity of available
information and hospices can choose to
use supporting materials to best
communicate the clinical rationale to
their patients. We do not expect that
this would mean hospices would have
to provide complex or technical
supporting information to patients to
rationalize their determinations.
However, similar to hospices explaining
what items, services, and drugs are
related to the palliation and
management of the terminal illness and
related conditions, we also believe that
they have the expertise to explain to
patients why certain items, services and
drugs are not related. Furthermore,
while there may be debate between
hospices and non-hospice providers
regarding whether or not certain items,
services, or drugs are unrelated, we
believe that the addendum provides a
tool to steer the debate and prompt
meaningful communication and care
coordination between all providers
rendering care to terminally ill
beneficiaries.
We agree with the hospice industry’s
views that hospice care is ‘‘the nation’s
first coordinated care model’’ and
should show how the health care system
can work at its best for patients at the
end of life.26 We think that an important
part of this care coordination is
communication with non-hospice
providers who are also providing care to
the patient, in order to ensure that
continuity of care and access to needed
services is part of the decision-making
process and we do not anticipate any
delay in the furnishing of items,
services, and drugs due to the provision
of this information to the patient.
26 NHPCO Op-ed: ‘‘Coordinated Care Is More
Than a Buzzword for Hospice Providers’’, April 24,
2018. https://morningconsult.com/opinions/
coordinated-care-more-than-buzzword-for-hospiceproviders/
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Similarly, the hospice CoPs at
418.56(e)(5) require that hospices
provide for an ongoing sharing of
information with other non-hospice
healthcare providers furnishing services
unrelated to the terminal illness and
related conditions.
Comment: Overall, while commenters
did not disagree in general with the
proposal of the election statement
addendum, the majority of commenters
stated concern with the proposed
timeframe with which the hospice
would be required to provide the patient
and caregiver such information.
Commenters indicated that 48 hours
after the time of hospice election is
insufficient considering that the hospice
has 5 days to complete the
comprehensive assessment.
Commenters noted that prior to the
comprehensive assessment, hospices
may not have a complete patient profile,
including the services or medications a
patient is currently utilizing. These
commenters stated that this may require
hospices to anticipate covered and noncovered services, which would lead to
an inaccurate election statement
addendum. Commenters stated that this
fails to provide patients with the
information the election statement
addendum is intended to convey. A few
commenters stated that the 48 hour
timeframe would not allow adequate
time to consult with the patient’s
certifying physician and/or the medical
director regarding medications and
treatments, or to provide a written
clinical explanation of why the
medications or services are unrelated.
Other commenters noted that nurses
may be required to complete and print
the election statement addendum in the
patient’s home, where clinical practice
and policy guidelines may not be
readily accessible, and would
necessitate the hospice providing nurses
with printers. Similarly, commenters
stated that this timeframe may pose
problems meeting signature
requirements if the patient or
representative does not return the
signed election statement addendum
within the required timeframe. Another
commenter suggested that this may
require a costly electronic solution or
modifications to the existing electronic
medical record (EMR).
Response: We understand the concern
regarding the proposed 48 hour
timeframe for providing the addendum
if requested at the time of a hospice
election. We recognize that in order to
provide the patient or representative
with the most accurate information, and
ensure the usefulness of the proposed
addendum, it would be beneficial to
align the timeframe of the completion of
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the addendum with the timeframe
requirement of the completion of the
comprehensive assessment, that is, if an
addendum is requested at the time of a
hospice election, the hospice would
have 5 calendar days to provide the
addendum to the requesting beneficiary
(or representative). This would allow
hospices sufficient time to assess all of
the patient and family needs, establish
the individualized plan of care, and
make decisions about any items,
services, or drugs they will not be
covering, as they have determined them
to be unrelated to the terminal illness
and related conditions. Furthermore, if
a beneficiary requests the addendum at
the time of hospice election and dies
within 5 days from the start of the
hospice election, the hospice would not
be required to furnish such addendum
as this requirement would be deemed as
being met in this circumstance.
We also understand that if the
beneficiary, representative, non-hospice
provider, or Medicare contractor
requests an addendum at any time
during the course of hospice care (that
is, after the election of hospice), the
hospice would need sufficient time for
the IDG to adequately review the
patient’s plan of care and review any
decisions on those items, services, or
drugs they have determined to be
unrelated to the individual’s terminal
illness and related conditions. As such,
we believe that the hospice should have
additional time to complete the
addendum, rather than the proposal to
require the hospice to provide it
immediately upon request during the
course of hospice care. Because the
hospice has already completed the
comprehensive assessment and has
begun providing care, we believe 72
hours after a patient, representative,
non-hospice provider or Medicare
contractor request for such information
represents a sufficient timeframe for
reviewing the patient record and
completing the addendum if this
information is requested during the
course of hospice care. As the plan of
care should identify the conditions or
symptoms that the hospice determines
to be ‘‘unrelated,’’ this information
should be readily accessible to the
hospice in order to allow for the timely
completion of the addendum.
Expanding the timeframe for completion
would ensure that the hospice has
adequate time to determine those items,
services, and drugs that are unrelated,
complete the written addendum, and
provide this information to the patient
(or his or her representative).
As detailed in the FY 2020 hospice
proposed rule, we proposed that each
individual hospice develop and
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incorporate the addendum into their
current admissions process in a way
that best meets the hospices’ needs, as
well as providing this information as
quickly as possible considering the
potential for beneficiary cost-sharing.
Likewise, non-hospice providers should
have timely access to this information in
order to promote continuity of care and
communication amongst all patient
providers and to ensure appropriate
claims submission.
Comment: Many commenters
suggested modifying the current
Advance Beneficiary Notice of Noncoverage (ABN) (Form CMS–R–131) or
the Home Health Change of Care Notice
(HHCCN) (Form CMS–10280) to be
hospice-specific to communicate
unrelated information regarding items,
services, and drugs, rather than
requiring hospices to develop a new
form. One industry association
suggested a ‘‘Hospice Change of Care
Notice’’ be developed and provided to
patients and representatives upon
request to meet the requirements for
communication about items and
services determined to be unrelated to
the terminal prognosis. This commenter
suggested providing this form after the
initial and comprehensive assessment
has been completed, the plan of care has
been established, and members of the
IDG have agreed upon the unrelated
items and services.
Others suggested offering patients
(and their representatives), upon
request, a list of known diagnoses
unrelated to the terminal illness and
related conditions with the
recommendation that this list could be
updated through the course of care if
any new unrelated diagnoses/conditions
became known. These commenters
stated that this would improve
transparency and hold hospices more
accountable for documenting and
communicating these unrelated
diagnoses to the patient and
representative. A few commenters
suggested the need for a patient/
representative statement acknowledging
that the patient or patient representative
has reviewed the items, services, and
medications with the hospice
representative in order to protect the
hospice from inadvertently excluding
any medications or treatments the
patient is receiving at the time of
admission, but that may not be revealed.
Commenters also suggested that the
patient be required to acknowledge that
a new election statement addendum
would be signed if additional noncovered items, services, or medications
were identified during the course of
treatment.
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Additionally, commenters noted that
the addendum should address items,
services and drugs that may be related,
but that the hospice is not covering, for
example a generic drug over a brand
name drug due to patient preference or
if a patient requests to continue using a
specific drug that the hospice
determines is no longer providing
medical benefit to the patient. A few
commenters recommended using the
Medicare form, Hospice Information for
Medicare Part D (OMB Form 0938–
1269) stating that most hospices already
use this form and that requiring a
separate addendum is redundant and
not necessary. Conversely, a few
commenters stated that the
aforementioned Part D form is fraught
with issues and there is inconsistency
with its use amongst hospices and Part
D plan sponsors. A few commenters
stated that this proposal is unreasonable
because no other healthcare provider is
required to furnish references for any
decision that the provider makes
regarding services not provided nor
requires a patient to sign a detailed
document listing what will not be
provided.
Response: We agree with commenters
that the list of items, services, and drugs
not covered by the hospice because they
have determined them to be unrelated to
the terminal illness and related
conditions should be in a format that
communicates this information to
patients and their representatives in the
most clear and unobtrusive way
possible. As stated earlier, we believe
that hospices should develop this
addendum, with the required content
elements, to best meet their patients’
needs and to align with their current
admission processes and other business
procedures. We disagree with
commenters about using a modified
ABN to communicate information about
hospice non-covered items, services and
drugs determined to be unrelated to the
terminal illness and related conditions.
The ABN, Form CMS–R–131, is issued
by providers (including independent
laboratories, home health agencies, and
hospices), physicians, practitioners, and
suppliers to Original Medicare (fee for
service—FFS) beneficiaries in situations
where Medicare payment is expected to
be denied. The ABN is issued in order
to transfer potential financial liability to
the Medicare beneficiary in certain
instances. Guidelines for issuing the
ABN are published in the Medicare
Claims Processing Manual, Chapter 30,
Section 50.27 As such, the purpose of
27 Medicare Claims Processing Manual Chapter
30—Financial Liability Protections. https://
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the ABN is to inform beneficiaries of the
listed items and services that Medicare
is not expected to approve, and the
specific denial reason (that is, not
medically reasonable and necessary),
whereas, the proposed hospice
addendum is intended to inform
beneficiaries of items and services that
the hospice will not cover as the
hospice has determined them to be
unrelated to the terminal illness and
related conditions, and therefore,
subject to coverage under other
Medicare benefits. Similarly, mandatory
use of the ABN is very limited for
hospices. The three situations that
would require issuance of the ABN by
a hospice are:
• Ineligibility because the beneficiary
is not determined to be ‘‘terminally ill’’
as defined in § 1879(g)(2) of the Act;
• Specific items or services that are
billed separately from the hospice
payment, such as physician services, are
not reasonable and necessary as defined
in either § 1862(a)(1)(A) or
§ 1862(a)(1)(C); or
• The level of hospice care is
determined to be not reasonable or
medically necessary as defined in
§ 1862(a)(1)(A) or § 1862(a)(1)(C),
specifically for the management of the
terminal illness and/or related
conditions.
An ABN is not required to be given
to a beneficiary for items and services
unrelated to the terminal illness and
related conditions. Additionally, an
ABN cannot be issued to transfer
liability to the beneficiary when
Medicare would otherwise pay for items
and services. Because the purpose of the
ABN is to notify beneficiaries of
Medicare non-coverage and shift
financial liability for payment of such
services to the beneficiary, we believe
that modifying the ABN for purposes of
notifying the beneficiary of items,
services, and drugs not covered by the
hospice as unrelated, may be more
confusing for patients in understanding
exactly what the hospice is
communicating and how to seek
coverage from other benefits.
The Home Health Change of Care
Notice (HHCCN) is provided to
beneficiaries to notify them of home
health plan of care changes. That is, the
HHCCN is given to a beneficiary where
there is a reduction or termination of
services listed on the home health plan
of care due to physician/provider orders
or limitations of the HHA providing the
specific service. While we agree that the
HHCCN has some similar components
of the proposed addendum (for
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/Downloads/clm104c30.pdf.
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example, the addendum would inform
beneficiaries of changes to non-covered
items and services and the reason for
the change), there are also inherent
differences between the HHCCN and the
proposed addendum. As stated in the
FY 2020 hospice proposed rule (84 FR
17594), the purpose of the proposed
addendum is to inform beneficiaries and
their families of those items, services,
and drugs determined by the hospice to
be unrelated to the terminal illness and
related conditions, and therefore, not
covered by hospice. In other words,
these are determined not to be hospice
items, services or drugs related to the
terminal illness, and therefore, would
not be considered the hospice’s
responsibility to provide. We believe
that the addendum should clearly state
that these are items, services, and drugs
that the hospice has determined to be
unrelated and therefore, not covered by
the hospice. However, as we are
proposing that hospices develop their
own addendum, there is nothing
prohibiting them from mirroring forms
such as the HHCCN to facilitate clear
communication between the hospice
beneficiary and their representative, as
long as the addendum includes the
required elements.
The suggested ‘‘Hospice Change of
Care Notice’’ sounds very much like the
proposed addendum given the purpose
of this suggested change of care notice
is to communicate similar information
as the addendum. However, the
timeframes accompanying the suggested
‘‘Hospice Change of Care Notice’’ allow
more time to complete the initial and
comprehensive assessment, establish
the plan of care with IDG input and
secure agreement of those items
unrelated to the terminal illness and
related conditions. As described above,
we agree that the timeframe for
completion of the requested addendum
should more accurately align with
already existing requirements. However,
as stated above, we believe that the
addendum should be clear in its
purpose that these are items, services,
and drugs the hospice has determined to
be unrelated to the terminal illness and
therefore not the hospice’s coverage
responsibility, but may be covered
under other Medicare benefits.
We believe that 5 days to complete
the addendum, if requested at the time
of a hospice election, should provide
adequate time for all of these activities
to occur and is in alignment with the
timeframe requirements at § 418.54(b)
for completion of the comprehensive
assessment. We remind hospices that
the hospice CoPs at § 418.54(b) require
that the RN, in consultation with the
other members of the IDG, considers the
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information gathered from the initial
assessment as they develop the plan of
care and the group determines who
should visit the patient/family during
the first 5 days of hospice care in
accordance with patient/family needs
and desires, and the hospice’s own
policies and procedures. A hospice does
not have to wait 5 days to complete the
comprehensive assessment as hospices
may choose to complete the
comprehensive assessment earlier than
5 days after the effective date of the
election (for example, the hospice may
complete the comprehensive assessment
at the same time as the initial
assessment). Care planning begins as
soon as the individual elects hospice
care and much of the care planning and
the decision-making occurs throughout
this period of time, so we believe that
completing the addendum within 5 days
of the hospice election (or within 72
hours if the addendum is requested
during the course of hospice care) is not
unreasonable.
While some commenters suggested
adding statements to the addendum to
acknowledge that the patient or patient
representative has reviewed the items,
services, and medications with the
hospice representative in order to
protect the hospice from inadvertently
excluding any medications or
treatments the patient is receiving at the
time of admission, and to acknowledge
that a new addendum would be signed
if additional non-covered items,
services, or medications are identified
during the course of treatment, we
proposed that the addendum would
include a statement that the addendum
is subject to review and shall be
updated, as applicable, in writing, to the
beneficiary (or representative).
Additionally, we proposed that the
addendum would include a statement
that signing the addendum (and any
updates) is only an acknowledgement of
receipt of the addendum and not
necessarily the beneficiary’s agreement
with the hospice’s determinations (84
FR 17595). If the beneficiary (or
representative) requests the addendum
at the time of the hospice election (that
is, at the time of admission to hospice),
hospices could include language on the
addendum that those unrelated
conditions, items, services, and drugs
are those the hospice has identified as
present on admission and that any
changes to this list (due to new,
changing, or inadvertently excluded
conditions, items, services, and drugs)
would be reflected in written updates to
the addendum. While we expect
hospices to be as thorough as possible
when completing the election statement
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addendum, we recognize that there may
be times when they are not aware of all
of the individual’s conditions/diagnoses
at the time of the hospice election,
which could result in information
inadvertently excluded on the
addendum. Consequently, hospices
have the option to make updates to the
addendum, if necessary, to include such
conditions, items, services and drugs
they determine to be unrelated
throughout the course of a hospice
election. We believe that the
requirements proposed and these
suggestions would mitigate hospices’
concerns regarding any items, services,
or drugs that may have been
inadvertently excluded when
completing the addendum.
Given that hospices would develop
their own addendum, hospices may add
additional language to inform
beneficiaries that the addendum reflects
the most accurate information that they
have at the time the addendum is
completed and that updates would be
provided, in writing, if there are any
changes that would need to be included
based on any new information.
While some commenters stated that
addendum should also address those
items, services, and drugs that may be
related, but that the hospice is not
covering, for example a brand name
drug as opposed to a hospice formulary
drug, or if a patient requests to continue
using a specific drug that the hospice
determines is no longer providing
medical benefit to the patient, we do not
think the addendum is the appropriate
mechanism to communicate this
information. The individualized hospice
plan of care is developed in accordance
with patient preferences and goals in
mind, including those related to drugs.
Decisions about those items, services,
and drugs should be made based on
collaboration between members of the
interdisciplinary group (IDG), the
patient’s attending physician (if any), as
well as the patient and their family.
This decision-making would include
determinations of what is reasonable
and necessary to meet the care plan
goals. We remind stakeholders that
when a beneficiary elects the hospice
benefit, he or she agrees to forego the
right to Medicare payment for services
related to the terminal illness and
related conditions unless provided by
the hospice. This would mean that if a
beneficiary wants to use a brand name
drug instead of its’ generic equivalent,
or wants to continue a drug that the
hospice has determined to no longer be
reasonable and necessary, the
beneficiary is liable for payment for the
drug. The purpose of the addendum is
to inform the beneficiary of those items,
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services and drugs the hospice has
determined to be unrelated to the
terminal illness and related conditions.
The scenario described by these
commenters reflects a situation in
which the drug would be related to the
terminal illness and related conditions
but is not on the hospice formulary.
Therefore, we believe it would be
confusing to provide beneficiaries
information on related items, services,
and drugs on the addendum meant to
document unrelated items, services, and
drugs not covered by the hospice. While
we do not routinely receive reports of
beneficiaries preferring to use a brand
name drug instead of a generic
equivalent drug on a hospice’s
formulary, we are aware of a few
instances in which that to be the case.
Therefore, we will continue to monitor
reports of these types of situations to
consider whether the use of the
addendum could be expanded and we
would make such proposals in future
rulemaking if warranted.
However, if there is a situation in
which the patient wants to continue
with related items, services, and drugs
that the hospice has previously been
providing, but that the hospice
determines are no longer reasonable and
necessary, or the patient decides to
switch to a brand name drug rather than
the generic equivalent on the hospice
formulary, and the hospice provides the
item, service, or drug, the hospice
would provide the beneficiary with an
ABN to notify the beneficiary that he or
she would be financially liable. If the
hospice does not continue to provide
the item, service, or drug, no ABN is
required to be given to the beneficiary.
If the beneficiary desires to continue
taking drugs that are not covered by
Medicare Part A (hospice) or Part D,
then the hospice must fully inform the
beneficiary of his or her financial
liability. Beneficiaries may also submit
quality of care complaints to a Quality
Improvement Organization (QIO) when
the beneficiary prefers a non-formulary
drug because, for example, it’s believed
to be more efficacious than the
formulary drug prescribed by the
hospice.
Beneficiaries who disagree with such
determinations may continue raising
these issues through the Medicare feefor-service appeals process if the
determination relates to Part A or B
coverage and the Part D appeals process
if the determination relates to Part D
coverage. Whether or not the hospice
furnishes the drug, if the beneficiary
feels that the Medicare hospice should
cover the cost of the drug, the
beneficiary may submit a claim for the
medication directly to Medicare on
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38513
Form CMS–1490S. If the claim is
denied, the beneficiary may file an
appeal of that determination under the
appeals process set forth in part 405,
subpart I.
We note that the hospice CoPs at
§ 418.56 require a review of the hospice
plan of care at least every 15 days, or
more often as the patient conditions
requires. This ensures that there are
ongoing discussions with the
beneficiary so that all hospice care is
provided in accordance with patient
needs. Similarly, the IDG should be
proactive in developing each patient’s
plan of care by planning ahead for
anticipated patient changes and needs.
Decisions should reflect patient/family
preferences and should not solely be a
response to a crisis.28 We believe that
the addendum is to be used as a tool to
have these discussions both at the time
of hospice election, when care planning
begins, and throughout the course of a
hospice election, as care planning
changes to meet the needs of hospice
patients and their families.
Regarding the use of the current
Hospice Information for Medicare Part D
(OMB Form 0938–1269), we note that
Part D plan sponsors currently have a
prior authorization process in place for
their member enrolled in hospice for the
four categories of drugs (analgesics, antinausea, anti-anxiety, and laxatives). A
voluntary, standardized prior
authorization (PA) form was developed
with industry input for hospices to
submit to Part D plans in order to assist
in:
(1) Proactively avoiding a drug claim
from rejecting at point-of-sale;
(2) Overriding reject edit at point-ofsale; and
(3) Communicating a change in the
patient’s hospice status.29
Hospices currently can use the
standardized PA form as a means of
notifying a Part D plan that their
member has elected hospice care, as
well as to document specific drugs that
are or are not being covered by the
hospice. We don’t agree that use of the
Hospice Information for Medicare Part D
(OMB Form 0938–1269) meets the
purpose of the addendum as the
Hospice Information for Medicare Part D
(OMB Form 0938–1269) is exclusively
for use for the identified four classes of
28 State Operations Manual Appendix M—
Guidance to Surveyors: Hospice. https://
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/downloads/som107ap_m_
hospice.pdf.
29 Hospice Information for Medicare Part D Plans,
OMB-approved form (No. 0938–1269). https://
www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/Hospice/Downloads/Instruction-andForm-for-Hospice-and-Medicare-Part-D.pdf.
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drugs (analgesics, anti-nausea, antianxiety, and laxatives) for hospice
beneficiaries who are seeking to receive
these drugs through their Part D
prescription coverage. Unfortunately,
this particular form is not
comprehensive enough to communicate
those items, services, and drugs (not just
the four classes) the hospice has
determined to be unrelated to the
terminal illness and related conditions.
However, as mentioned in the FY
2020 hospice proposed rule (84 FR
17596), we intend to work with
hospices and Part D plans to develop a
process in which the addendum
potentially could be used at the pointof-service when hospice beneficiaries
are filling drug prescriptions to ensure
timely access to needed drugs. Complete
documentation on the part of the
hospice, coupled with timely
notification of Part D sponsors, mitigates
the risk for possible double payment by
the Medicare program for drugs, and is
anticipated to prevent Part D enrollees
in hospice from having a hospice related
medication billed by a pharmacy to
their Part D plan, potentially subjecting
the beneficiary to out-of-pocket
expenses.
Comment: Several commenters report
that obtaining signatures on the
addendum statement would be
prohibitively challenging. These
commenters cited instances where it is
extremely difficult obtaining the
patient/representative signature for the
hospice election statement and
expressed concerns about having a
requirement to obtain a signature again
on the addendum. Reasons for these
challenges included having
representatives who live in a different
state from the hospice beneficiary who
may be unable to make healthcare
decisions on his or her own, lack of
readily available technology such as
patients or representatives not having
email accounts or access to a fax
machine in order to return signed
documents. Other commenters asked
specific questions regarding the
frequency of providing the addendum
and whether the signature would be
required on each version of the
addendum. Another commenter
remarked that other providers, such as
home health agencies, are not required
to obtain patient/representative
signature for changes to the plan of care
and stated that as the addendum would
be similar to a change in the home
health plan of care, requirements for the
hospice addendum should be a similar
process. A few commenters requested
further guidance regarding the
acceptance of an electronic patient
signature for the addendum.
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Response: We note that the hospice
regulations at § 418.24(b) require that
the patient or representative sign the
election statement. We appreciate the
challenges that commenters have
identified in obtaining a signature on
the election statement, however, we
note that obtaining the required
signatures on the election statement has
been a longstanding regulatory
requirement. We expect that hospices
already have processes and procedures
in place to ensure that required
signatures are obtained, either from the
beneficiary or his or her representative
in the event that the beneficiary is
unable to sign and we expect that the
same procedures may be used for
obtaining signatures on the addendum.
Likewise, the hospice CoPs at
§ 418.52(a)(3) require that the hospice
obtain the patient’s or representative’s
signature confirming that he or she has
received a copy of the notice of rights
and responsibilities. Therefore, we
believe that it is not unreasonable to
require that the addendum also be
signed to ensure that the patient is
aware of the important information
about hospice non-covered items,
services, and drugs. As noted previously
in this rule and in the proposed rule (84
FR 17608), the addendum would be
signed by the beneficiary as an
acknowledgement that he or she has
received this information, but signing it
does not mean the beneficiary agrees
with the determination.
Contrary to commenters’ statements
that beneficiaries receiving home health
services are not required to sign when
there are changes to the home health
plan of care, the HHCCN form (CMS
Form 10280) is completed when there
are changes to the home health plan of
care due to a reduction or termination
of home health services, and the
beneficiary or representative is required
to sign and date the HHCCN confirming
his or her review and understanding of
the notice.30 31 Additionally, the home
health CoPs at § 484.60(c)(3)(ii) require
that any revisions related to plans for
the patient’s discharge must be
communicated to the patient,
representative, caregiver, all physicians
issuing orders for the HHA plan of care,
and the patient’s primary care
practitioner or other health care
professional who will be responsible for
30 Form Instructions for the Home Health Change
of Care Notice (HHCCN) CMS–10280. https://
www.cms.gov/Medicare/Medicare-GeneralInformation/BNI/Downloads/HHCCN-FormInstructions.pdf.
31 Medicare Claims Processing Manual Chapter
30—Financial Liability Protections. https://
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/Downloads/clm104c30.pdf.
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providing care and services to the
patient after discharge from the HHA (if
any). We also remind stakeholders that
the HHCCN references services that are
or were provided under the home health
plan of care. Conversely, the addendum
is used to communicate items, services,
and drugs that would not be on the
initial (or subsequent) hospice plan of
care to ensure coverage transparency
where the hospice has determined that
certain items, services, or drugs would
not be covered (that is, furnished and
paid for by the hospice) because they
are unrelated to the terminal illness and
related conditions.
In summary, we continue to believe
that because of the significance of the
decision to elect hospice care and waive
the right to Medicare payment for care
related to terminal illness and related
conditions, the terminally ill individual
(and his or her representative) must
have information related to all aspects
of their care, including what the hospice
has determined to be ‘‘unrelated’’.
Requiring the patient to sign the written
addendum memorializes that this
important information has been
provided by the hospice to the
beneficiary.
Comment: Several stakeholders
strongly urged CMS to examine nonhospice expenditures to determine what
proportion is actually the responsibility
of, and within the control of, the
hospice before implementing a
mandatory process for hospices.
Commenters noted that there are
frequent instances when care is
provided to hospice patients without
the hospice’s knowledge and the
hospice discovers that the item, service,
or drug has been provided only after the
fact. An industry association stated that
the language in the proposed rule
presupposes that it is only the hospice’s
responsibility to communicate with
other providers and offered ideas for
improving the flow of communication
between hospice and non-hospice
providers. Commenters noted that other
providers may be unaware that a patient
has elected hospice and that they need
to coordinate with the patient’s hospice
to determine whether the services are
unrelated to the terminal prognosis and
that these non-hospice providers must
treat claims for hospice beneficiaries
differently with the use of modifiers or
a condition code. These commenters
recommended that CMS and Medicare
Administrative Contractors (MACs)
provide clear guidance to physicians on
billing requirements for using the GV
and GW modifiers and to circulate this
guidance widely in a variety of
publications to promote awareness of
these billing requirements as they
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related to non-hospice care for hospice
beneficiaries. Some suggested that nonhospice providers should share in the
responsibility of identifying their
patients who are under a hospice
election. These suggestions included
making Medicare system changes to
allow for a shortened process that
would expedite the notification of
election in the Common Working File
(CWF), implementing flags in the
Medicare claims processing systems to
notify other provider types of the
hospice election and requiring these
other providers to communicate and
coordinate with the hospice, as well as
asking beneficiaries and/or their
representative if they are a hospice
patient.
Response: While we agree that all
participating Medicare providers should
actively engage in ongoing
communication and care coordination
to ensure that Medicare beneficiaries
receive appropriate care, the proposed
rule primarily focused on the hospice’s
responsibility in these activities. The
hospice CoPs at § 418.56(e) detail the
requirements of hospice care
coordination. Specifically, the hospice
CoPs require that the hospice provide
for an ongoing sharing of information
with other non-hospice healthcare
providers furnishing services unrelated
to the terminal illness and related
conditions. Furthermore, hospices are
required to have systems in place to
facilitate the exchange of information
and coordination of services among staff
and with other non-hospice healthcare
providers. Likewise, hospices are
required to have documentation in the
clinical record of the sharing of
information between all disciplines
providing care and with other
healthcare providers furnishing services
to the patient.32 The goal of this
coordination is to ensure that the
patient’s hospice plan of care is
implemented, and that the hospice care
is furnished in concert with other care
sources to ensure that all patient needs
are met (73 FR 32099). We expect the
hospice plan of care to address all
patient goals in some way. If a patient
has a goal that is not related to the
terminal illness and related conditions,
and if the hospice does not intend to
address this goal, then the hospice plan
of care should identify the party that is
responsible for meeting the unrelated
goal. Furthermore, § 418.56(e) requires
the hospice to actively communicate
with the outside party to ensure that the
goal is addressed. Therefore, given the
comprehensive nature of the Medicare
hospice benefit and the CoPs regarding
the pivotal role hospices are required to
play in care coordination, we believe
hospices are primarily responsible for
communication and care coordination
with non-hospice providers while a
beneficiary is under a hospice election.
Likewise, the requirement that care is
provided under the direction of an IDG
means that the approach to patient care
under hospice is holistic and requires
the hospice to be primarily responsible
for the medical, emotional, and spiritual
care of the individual.
To address comments regarding
physician education on the appropriate
use of the GW and GV modifiers, we
remind stakeholders that CMS does
routinely provide information on
various aspects of the Medicare program
include educational materials on
Medicare benefits and claims
processing. There is a MLN Matters®
article, ‘‘Hospice Related Services—Part
B’’, intended for physicians submitting
claims to Medicare Administrative
Contractors (MACs) for services
provided to Medicare beneficiaries who
are in a hospice period of coverage.33
Likewise, the Medicare claims
processing manual, chapter 11,
‘‘Processing Hospice Claims’’ includes
detailed information on the appropriate
use of the GW and GV modifiers. We
believe these are the most appropriate
CMS mechanisms for providing such
information to physicians and other
providers of services.
To address comments regarding
making changes to the Medicare systems
to allow for a shortened process to
update the CWF, we note that CWF
processing time still varies because of
whether an NOE must go through the
one-time out of service area (OSA)
process. OSA processing occurs when a
beneficiary’s master record is not found
on the local CWF host site for the MAC
and several nightly batch cycles are
required to query each of the other host
sites to find it. This process is standard
for all claims and cannot be revised just
for hospice without creating risk for all
other Medicare payments. While
Electronic Data Interchange (EDI)
submission of NOEs does not affect the
processing time in CWF, it reduces
delays caused by keying errors. Once
the NOE is accepted at CWF, the
hospice record is available for all
providers on the HIPAA (Health
32 State Operations Manual Appendix M—
Guidance to Surveyors: Hospice. https://
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/downloads/som107ap_m_
hospice.pdf.
33 MLN Matters®Number: SE1321, Hospice
Related Services—Part B.November 2014. https://
www.cms.gov/Outreach-and-Education/MedicareLearning-Network-MLN/MLNMattersArticles/
Downloads/SE1321.pdf.
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Insurance Portability and
Accountability Act) Eligibility
Transaction System (HETS) inquiries.
The HETS allows providers to check
Medicare beneficiary eligibility data in
real-time. Providers are encourage to use
HETS to prepare accurate Medicare
claims, determine beneficiary liability,
or check eligibility for specific services.
Comment: A few commenters
expressed concern over the role of the
QIO when beneficiaries disagree with
the hospice determination as to those
items, services, and drugs. These
commenters disagreed with having to
include QIO information on the election
statement given hospices are already
required to provide information to
beneficiaries regarding QIOs at hospice
admission. Other commenters expressed
concerns over how QIO determinations
would be made, given that these
determinations are within the scope of
a hospice physician who has medical
information in the clinical record with
which to base such a determination.
These commenters stated that unless the
QIO reviewer is a physician with
experience/training in end-of-life care
and has sufficient information, the QIO
reviewer could not make a
determination as to whether the
hospice’s determination of
unrelatedness is correct and
appropriate. Commenters request
additional clarity about the BFCC–QIO
findings and how the hospice is to
implement them so there is no
confusion regarding the authority of the
BFCC–QIO, the hospice medical
director, and the MACs when
determining relatedness, eligibility, and
continued coverage of hospice services.
A few commenters remarked that the
crux of the issue is the lack of
guidelines provided by CMS as to how
determinations of relatedness are made,
other than it is the responsibility of the
hospice physician. One commenter
stated that relatedness is vague. One
industry association reiterated that there
is a lack of clarity around what
‘‘relatedness’’ means and that guidance
should be updated and be more specific.
This commenter stated that the repeated
requests for clarification underscores
the reality of how decisions are being
made. This commenter went on to state
that there are those hospices that have
a broad, holistic view and philosophy of
care that is in alignment with CMS’
intent and is aligned with their
organizational mission and values,
though this commenter remarked that
there are those hospices that take
advantage of the ‘‘gray space’’ and
manipulate the system to avoid payment
of items, services, and drugs that should
be the hospices’ responsibility. Finally,
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this commenter recommended that CMS
work with stakeholders to develop more
standardized definitions of related and
unrelated in order to promote
consistency of delivery across the
benefit and where the need for an
addendum would be unnecessary as a
result.
Response: We remind stakeholders
that Immediate Advocacy with the
Beneficiary and Family Centered Care
Quality Improvement Organization
(BFCC–QIO) is an informal alternative
dispute resolution process used to
quickly resolve a Medicare beneficiary’s
(or his or her representative’s) verbal
complaint regarding the quality of
Medicare-covered health care received
or services that accompany medical care
(for example, medical equipment). This
process involves the BFCC–QIO directly
contacting the beneficiary’s practitioner
or provider, usually by telephone. The
process is voluntary for both the
beneficiary and the provider or
practitioner. The purpose of Immediate
Advocacy is to provide a flexible,
dialogue-based resolution process
between the beneficiary and the
provider.
There are specific criteria for
eligibility for Immediate Advocacy. A
QIO may offer Immediate Advocacy to
the beneficiary prior to obtaining a
written beneficiary complaint when the
following criteria are met:
1. After initially screening the
complaint, the QIO determines the
complaint was received within 6
months from the date of service on
which the care occurred concerning the
complaints and:
a. The beneficiary complains about a
matter that is unrelated to the clinical
quality of health care itself but that
relates to items or services that
accompany or are incidental to the
medical care and are provided by a
practitioner and/or provider (for
example, beneficiary in search of or
needing an intervention for resources
and/or services covered by Medicare,
such as a wheelchair that was not
delivered, a beneficiary concerned about
the quality of communication with their
practitioner and/or provider); or
b. The beneficiary complains about a
matter that, while related to the clinical
quality of health care the beneficiary
received, does not rise to the level of
being a ‘‘gross and flagrant,’’
‘‘substantial,’’ or ‘‘serious or urgent’’
quality of care concern. This may
include situations where the QIO
determines that the medical information
will most likely not contain evidence
related to the complaint.
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2. The beneficiary agrees to the
disclosure of his or her name. (42 CFR
476.110(a)(3)).
3. All parties orally consent to the use
of Immediate Advocacy. (42 CFR
476.110(a)(4)).
4. All parties agree to the limitations
on redisclosure; namely, all
communications, written and oral,
exchanged during the Immediate
Advocacy process must not be
redisclosed without the written consent
of all parties (42 CFR 476.110(c) and
480.107).
If the practitioner/provider opts NOT
to participate in the Immediate
Advocacy process, the QIO must
immediately contact the beneficiary and
give him or her the opportunity to file
his or her complaint in writing.34
As noted previously, the regulations
at § 476.110 set forth the requirements
as they relate to the Immediate
Advocacy process which is meant to be
an informal alternative dispute
resolution process used to quickly
resolve an oral complaint a Medicare
beneficiary or his or her representation
has regarding the quality of Medicare
covered health care received. This
process involves a QIO representative’s
direct contact with the provider and/or
practitioner. When a quality of care
complaint is handled through the
Immediate Advocacy process, the QIO
does not make clinical determinations
based on whether or not it agrees with
the hospice’s determination about
whether or not the disputed items,
services, or drugs are unrelated to the
terminal illness and related conditions,
but rather facilitates discussion between
the beneficiary and the hospice to see if
the two parties can come to a
satisfactory resolution. While it cannot
require services be covered, provided, or
be paid for by Medicare, the BFCC–QIO
addresses quality of care issues for
Medicare beneficiaries. Additionally,
with the agreement to use Immediate
Advocacy, a Peer Review is not
performed. A Peer Review is a review by
health care practitioners of services
ordered or furnished by other
practitioners in the same professional
field and is generally part of the written
complaint process through the QIO. If
the QIO receives a written complaint,
Immediate Advocacy may not be
offered; rather the written complaint
would be subject to the Beneficiary
Complaint Review Peer Review
process.35 Furthermore, medical
34 Quality Improvement Organization Manual
Chapter 5—Quality of Care Review. https://
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/Downloads/qio110c05.pdf.
35 Quality Improvement Organization Manual
Chapter 5—Quality of Care Review. https://
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information should not be requested
from the practitioner or provider for this
Immediate Advocacy process. While the
goal of Immediate Advocacy is to
informally and quickly resolve the
beneficiary’s complaint, in certain
instances the beneficiary might remain
dissatisfied after completion of
Immediate Advocacy. Should this
occur, the QIO must advise the
beneficiary of his or her right to file a
written complaint. Therefore, we
reiterate to commenters that the role and
scope of the BFCC–QIO’s Immediate
Advocacy authority is limited, as
described in regulation.
We also remind commenters that the
hospice medical director must consider
all health conditions, whether related or
unrelated to the terminal condition, as
well as current clinically relevant
information supporting all diagnoses
when making the decision to admit a
patient into hospice (42 CFR 418.25).
Additionally, all hospice care and
services furnished to patients and their
families must follow the individualized
written plan of care established by the
hospice interdisciplinary group in
collaboration with the attending
physician (if any), the patient or
representative, and the primary
caregiver in accordance with the
patient’s needs if any of them so desire
(42 CFR 418.56). The hospice must
ensure that each patient and the primary
care giver(s) receive education and
training provided by the hospice as
appropriate to their responsibilities for
the care and services identified in the
plan of care. The plan of care must
specify the hospice care and services
necessary to meet the patient and
family-specific needs identified in the
comprehensive assessment as such
needs relate to the terminal illness and
related conditions (42 CFR 418.56).
Based on this information, each hospice
makes the determination as to what
items, services, or drugs are considered
related to the terminal illness and
related conditions, and belong on the
plan of care. However, that is not to say
that these determinations cannot be
questioned by the beneficiary, or his or
her representative. Therefore, the
addendum is to provide the information
on hospice determinations as to what
unrelated items, services, and drugs it
will not be covering to spur
conversations with the patient about
these determinations and the impact on
the patient. In addition, Immediate
Advocacy is a process in which the
beneficiary can question such
determinations.
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/Downloads/qio110c05.pdf.
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In response to comments regarding
concerns about the vagueness of
‘‘relatedness’’ and requests for
additional CMS guidance as to what is
‘‘related’’ and ‘‘unrelated’’, we remind
commenters that since the
implementation of the Medicare hospice
benefit, it has been our position that
virtually all of the care needed by
terminally ill individuals should be
provided by the hospice (48 FR 56010).
As such, there should not be a
voluminous list of unrelated items,
services, and drugs given the
comprehensive nature of hospice
services under the Medicare hospice
benefit and the requirement that the
hospice provide care addressing the
physical, medical, psychosocial,
emotional, and spiritual needs of
hospice patients and families facing
terminal illness and bereavement. We
note that in the FY 2015 hospice
proposed rule (79 FR 26538) we
solicited comments on definitions of
‘‘terminal illness and related
conditions.’’ We received a significant
number of comments on these
definitions, with most commenters
opposing CMS proposing these
definitions. Commenters stated that
hospices were the experts at making
such clinical determinations and that
the statute and hospice regulations
allow for hospices to make such
determinations. Commenters noted that
the hospice should be the entity that
establishes a process to make
determinations as to what is related and
unrelated to the terminal illness and
related conditions on a patient-bypatient basis. Due to this feedback, we
have not proposed definitions for
‘‘terminal illness or related conditions’’.
We understand that national industry
associations have subsequently engaged
in activities with hospices to
communicate a process for helping
hospices make these relatedness
determinations in the form of clinical
decision-making process workflows.36
We appreciate these efforts and ongoing
dialogue amongst the hospice industry
in addressing best practices in making
clinical decisions to provide
comprehensive and holistic care to
hospice beneficiaries and their families.
Comment: Some commenters
suggested that rather than implement
sweeping regulations required of all
hospices, CMS should implement a
more targeted approach by analyzing
data to identify hospices that are out of
compliance with the coverage of DME
36 Determining Relatedness to the Terminal
Prognosis Process Flow, National Hospice and
Palliative Care Organization. December 2014.
https://wshpco.org/media/Relatedness_Process_
Flow_FINAL_2.14.pdf.
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and disease-specific drugs and
penalizing them directly for failure to
provide such services. One commenter
remarked that most hospices provide all
items, services, and drugs in good faith
and in accordance with Medicare
regulations and therefore should not be
subject to unnecessary requirements.
Another commenter recommended that
CMS take additional steps to identify
the breadth of the issues contributing to
non-hospice spending and address
inappropriate spending outside of the
hospice benefit accordingly.
Specifically, this commenter suggested
that CMS determine what proportion of
hospice spending is occurring within
the first few weeks of hospice care when
the CMS systems have not been updated
with Medicare notice of election
information and where the hospice is
informing non-hospice providers that
the item, service, or drug is unrelated.
One commenter stated that a simple
solution would be to block all Medicare
services without hospice approval. One
commenter wrote that the addendum
proposal would make hospices look like
‘‘the bad guy’’ in communicating those
items, services, and drugs they have
determined to be unrelated even if the
hospice is providing this information in
good faith.
Response: For those providers who do
furnish all items, services and drugs for
hospice patients, this requirement
would be met in that there would be no
request for an addendum as the hospice
would be furnishing all of the patient’s
care needs. We remind stakeholders that
the hospice regulations are applicable to
all Medicare-participating hospice
providers. Program integrity audits and
survey actions are appropriate
mechanisms to enforce the payment
regulations and the CoPs. If there are
identified program integrity concerns or
CoP violations, the appropriate targeted
actions can then be taken for those who
do not meet the requirements.
To reduce the incidence of
inappropriate payments for beneficiaries
under a hospice election, hospices are
required to submit a Notice of Election
(NOE with its Medicare contractor
within 5 calendar days after the
effective date of the election statement.
The purpose of a timely-filed the NOE
is to alert the Medicare claims
processing system that a beneficiary is
under a hospice election to avoid
inappropriate or duplicative payments
to other Part A, Part B, or Part D
providers, and to safeguard beneficiaries
from inappropriate liability for
copayments or deductibles.
We have been analyzing non-hospice
spending for a number of years and have
been presenting information on the
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breadth of this issue in proposed and
final rules (for instance, our FY 2016
hospice wage index proposed rule at 80
FR 25849, and our FY 2019 hospice
wage index proposed rule at 83 FR
20946). We also note that in examining
non-hospice spending, we have
excluded admission and discharge dates
as part of our analysis. In the future, we
will consider examining other time
points of non-hospice spending,
including the proportion of spending
that is occurring in the first 5 days of a
hospice election where the claims
processing system may not yet be aware
of the hospice election.
We oppose blocking all beneficiary
access to services ordinarily covered by
Medicare without hospice approval
because the complexity of instituting
such a process would potentially delay
access to needed items, services, and
drugs.
Non-hospice providers are already
required to submit claims with the
appropriate modifier when furnishing
services to beneficiaries under a hospice
election. Non-hospice providers are
required to report the GW modifier (or
condition code 07 for institutional
providers) to identify that services were
unrelated to the terminal illness and
related conditions or the GV modifier to
identify that services were related to the
terminal illness and related conditions.
For beneficiaries enrolled in hospice, A/
B MACs (B) shall deny any services on
professional claims that are submitted
without either the GV or GW modifier.
Therefore, there is already a mechanism
in place to prevent inappropriate
payments during a hospice election. As
we stated in the FY 2020 proposed rule
(84 FR 17597), we also believe that the
addendum may allow the non-hospice
provider to be ‘‘without fault’’ if there
is any question regarding an
overpayment. In accordance with
section 1870 of the Act, a provider is
responsible for an overpayment if the
provider knew or had reason to know
that service(s) were not reasonable and
necessary, and/or the provider did not
follow correct procedures or use care in
billing or receiving payment. If nonhospice providers were given access to
a patient’s addendum, this potentially
could provide evidence under section
1870 of the Act in demonstrating that
the non-hospice provider did or did not
have reason to know that the services
provided by the non-hospice provider
were duplicative, or otherwise not
reasonable and necessary (considering
the service itself was otherwise
reasonable and necessary and satisfied
all other requirements for payment).
Moreover, if a non-hospice provider
submitted a claim to Medicare for
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services provided to a beneficiary that
were unrelated to the terminal illness
and related conditions but did not have
the supporting documentation
demonstrating that the services were
unrelated, this could, among other
things, delay payment. Having the
addendum identifying the unrelated
conditions, items, services, and drugs
may provide the necessary
documentation support that the nonhospice provider was rendering services
unrelated to the terminal illness and
related conditions. Therefore, the
addendum could assist in more accurate
claims submission, mitigate potential
duplicative payments, and provide nonhospice providers with documentation
to support a ‘‘without fault’’
determination.
Finally, we disagree that the purpose
of furnishing an addendum to
communicate hospice non-covered,
unrelated items, services, and drugs is
to make the hospice look like ‘‘the bad
guy’’. Again, hospices are already
required to inform beneficiaries of
coverage under the Medicare hospice
benefit. As such, providing this
information supports the philosophy of
care of putting patients first, promoting
patient choice, and advocating for
patient autonomy.
Comment: A majority of commenters
opposed the proposal that the
addendum be a condition for payment.
Many commenters suggested that
instead of a condition for payment, the
proposed addendum should be a CoP, as
they believe that protection of patient
rights is more appropriately reviewed
under the survey oversight process.
Commenters stated that in order for the
proposed addendum to be a condition
for payment, there would need to be a
standardized process of recording any
unrelated items, services, and drugs and
documenting whether or not the
addendum was requested in the
patient’s medical record. Several
commenters questioned how an
addendum that is mandatory, but only
upon request, could be appropriately
used as a condition for payment. Many
commenters expressed concern over the
implications for auditing under medical
review. Specifically, commenters asked
how to protect themselves from claims
denials if there is no addendum (or
addendum updates) present in the
medical record because there was no
patient (or representative) or provider
request. Others question whether the
MACs would use the addendum for
claims denials if the MAC disagrees
with the hospice’s determinations. A
national industry association stated that
the process to determine whether the
addendum was requested, when it was
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requested, whether it is present, and
whether the condition for payment
requirement has been met, is fraught
with issues. Several commenters
requested that CMS develop specific
protections to prevent claims denials
solely because an addendum is not in
the medical record and to state that the
addendum would not be used to dispute
determinations of relatedness which
could result in claims denials. A few
commenters thought that the addendum
should be provided to every hospice
beneficiary, whether requested or not, to
protect the hospice from claims denials
resulting from missing addendums in
patients’ medical records. A few
commenters stated that the vast majority
of patients have no unrelated conditions
and therefore it seems unnecessary to
require such a form. Another
commenter believed that the addendum
would have a chilling effect at the time
of hospice election and may deter
admissions, especially for those patients
who are reluctant to discontinue certain
services and drugs, like maintenance
medications.
Response: While we understand
stakeholder concerns about including an
addendum statement as a condition for
payment, we believe this is necessary to
ensure that hospices are diligent in
providing this information to Medicare
hospice beneficiaries on request. We
regard this addendum as an important
mechanism of accountability for
hospices to provide coverage
information to beneficiaries electing the
hospice benefit. We also believe that the
various reports by the OIG (for example;
OEI–02–16–00570, July, 2018,
‘‘Vulnerabilities in the Medicare
Hospice Program Affect Quality Care
and Program Integrity: An OIG
Portfolio,’’ 37 and A–06–10–00059, June
2012, ‘‘Medicare Could Be Paying Twice
For Prescription Drugs For Beneficiaries
In Hospice’’) 38 highlight the issues with
a patient’s lack of knowledge of
hospices’ limitation on their coverage,
and the possibility of hospices
potentially not covering items, services,
and drugs that should be hospices’
responsibility. We reiterate that the
election statement addendum, as a
condition for payment, would achieve
the goal of increasing comprehensive
patient education, awareness,
empowerment, and coverage
transparency. As stated in the FY 2020
37 Vulnerabilities in the Medicare Hospice
Program Affect Quality Care and Program Integrity:
An OIG Portfolio. July 2018. https://oig.hhs.gov/oei/
reports/oei-02-16-00570.pdf.
38 Medicare Could Be Paying Twice for
Prescription Drugs for Beneficiaries in Hospice (A–
06–10–00059). June 2012. https://oig.hhs.gov/oas/
reports/region6/61000059.pdf.
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hospice proposed rule, this does not
mean that in order to meet this
condition for payment that the
beneficiary (or representative), or nonhospice provider must agree with the
hospice’s determination. For purposes
of this condition for payment, the
signed addendum is only
acknowledgement of the beneficiary’s
(or representative’s) receipt of the
addendum (or its updates) and this
payment requirement would be met if
there was a signed addendum (and any
signed updates) in the requesting
beneficiary’s medical record with the
hospice. Likewise, this addendum
would not be required to be submitted
with any hospice claims. While we
agree that this could be a CoP as
opposed to a condition for payment, we
continue to believe that as a condition
for payment, this would ensure a more
comprehensive and thoughtful approach
by hospices in communicating
important coverage information to
beneficiaries.
We agree that it would be helpful for
hospices to have a standardized
documentation process for recording
any unrelated items, services, and drugs
and expect that many hospices may
already have a documentation process
in place, given the existing requirements
for admission to hospice and
development of the individualized plan
of care. We would expect hospices to
document, in some fashion, that the
addendum was discussed with the
patient (or representative) at the time of
admission, similar to how other patient
and family discussions are documented.
Likewise, hospices can develop a way to
document whether or not the addendum
was requested at the time of hospice
election (or at any time throughout the
course of hospice care). This could be
done in checklist format or as anecdotal
notes by the nurse. However, we did not
propose a specific format in which to
document such conversations and
hospices can develop their own
processes to incorporate into their
workflow. We believe that careful
documentation that the addendum was
discussed and whether or not it was
requested would be an essential step
hospices could take to protect
themselves from claims denials related
to any absence of an addendum (or
addendum update) in the medical
record.
We are aware of commenter concerns
about the potential for this addendum to
be used for medical review auditing
purposes if it is a condition for
payment. We note that there is no
current process for the MACs to make
determinations of ‘‘relatedness’’. We
remind commenters that the regulations
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afford hospices this responsibility in
accordance with the CoPs at § 418.56.
Therefore, the hospices’ determination
of those unrelated items, services, or
drugs reported on the addendum could
not be used solely to deny hospice
claims. Nonetheless, to assuage
commenter concerns about increased
claims denials and documentation
requests, we will collaborate with the
MACs to establish clear guidelines on
the use of the addendum as a condition
for payment and we will propose any
requirements in future rulemaking, as
necessary. We do not want hospices to
perceive that the purpose of this
addendum is punitive against hospices,
nor that it is a mechanism to deny
claims; rather we want hospices to
understand that the intent of this
addendum is to keep patients at the
forefront of their decision-making
equipped with adequate information to
make care choices as they approach the
end of life.
While hospices can choose to provide
the addendum to every electing
beneficiary, we are not requiring that it
is mandatory, unless the patient (or
representative) requests the addendum.
We encourage hospices to review their
current admission processes to see how
the addendum could assimilate into
their procedures to help ameliorate any
issues upon implementation. We believe
that because hospices already should
have processes in place to make
determinations about those items,
services, and drugs that they will not
cover because they are unrelated to the
terminal illness and related conditions,
hospices will be able to adapt the
addendum into their current processes.
Finally, we disagree that the provision
of the addendum would have a ‘‘chilling
effect’’ on hospice admissions.
Generally, beneficiaries make decisions
that are based on information furnished
by providers rendering care. We
continue to assert that the information
provided in the addendum will allow
beneficiaries to make those decisions to
best meet their preferences and goals of
care and will mitigate any unexpected
need to seek services outside of the
hospice and assume the associated costsharing. We believe beneficiaries and
their families would appreciate full
disclosure from the hospice as to what
to expect when electing the Medicare
hospice benefit.
Comment: The majority of
commenters agreed that if the
addendum is finalized, the effective
date should be delayed until FY 2021,
at minimum, in order to ensure that
hospices and software vendors have
adequate time to develop the
addendum, modify the existing election
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statement to include the new content
requirements, and develop and educate
on the protocols and procedural changes
necessary to incorporate the addendum
into hospice work flow processes, as
well as work with non-hospice
providers to ensure compliance.
Response: We understand that making
modifications to the election statement
and developing an addendum to
accompany the election statement will
take time for hospices to create, educate
staff, and incorporate into current
admission processes. Likewise, we
recognize that there are some additional
logistical and operation considerations
(see response below) that we will need
to consider and communicate to the
hospice industry to help ensure a more
seamless implementation. Therefore, we
will finalize an effective date of FY 2021
for the election statement modifications
and the addendum. This delayed
effective date will allow sufficient time
for us to develop a model election
statement addendum to provide the
industry as they move forward making
the changes to their own election
statements and as they develop an
addendum to communicate those items,
services, and drugs they will not be
covering because they have determined
them to be unrelated to the terminal
illness and related conditions. This
additional year will allow hospices to
make any current process and software
changes to incorporate the addendum
into their workflow.
Comment: Many commenters stated
that CMS underestimated the amount of
time it would take for the nurse to
complete the addendum stating that 10
minutes is an insufficient amount of
time to extrapolate this information
from the existing documentation. A few
commenters stated that this would take
between 20 and 30 minutes to complete.
Others stated that this is not just a
process of extrapolating the information,
but that this is often a process of
information gathering as not all relevant
information is readily available at the
time of the initial assessment. However,
a few commenters believed that even
though the timeframe to complete the
addendum would be longer than 10
minutes, they suggested that the
addendum should not be optional but
patients (or their representatives) should
be provided this detailed list as this is
critical to the care process, patient
empowerment, quality of care, and
transparency. One commenter stated
that the addendum proposal would be
improved by adding appropriate
reimbursement for the time and process
redesign needed to make this a
successful addition to hospice practice.
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Additionally, the majority of
commenters stated that this would
significantly increase burden for
hospices, as well as for patients and
their families and could potentially
impede access to care stating that this
conflicts with CMS’ Patients over
Paperwork initiative. Commenters cited
such concerns as the increase in time
spent gathering, documenting, and
communicating this information, as well
as providing copies of such information,
in writing, to patients, their
representatives, non-hospice providers,
and Medicare contractors.
Response: While we understand
commenter concerns over the time it
takes to complete the addendum, we
remind hospices that the addendum is
not a requirement for every electing
beneficiary. Several commenters stated
that because they do provide such a
comprehensive range of services most
beneficiaries would not need an
addendum. We continue to believe that
once a beneficiary elects the hospice
benefit, most items, services, and drugs
would be for the palliation and
management of the terminal illness and
related conditions and that there would
be few things that would be unrelated.
Furthermore, because hospices should
already be considering those items,
services, and drugs they have
determined to be unrelated as part of the
admission and care planning process,
we believe that providing such
information, in writing, to the
beneficiary (or representative) should
not take a significant amount of time.
Additionally, hospices would develop
their own addendums, in a format that
suits them to best meet the requirements
and patient needs while minimizing
operational burden. We also stated in
the proposed rule that we would
develop a model addendum to help
hospices in developing their own.
Several commenters stated that most
hospices use the current model election
statement so we trust that hospices
would take advantage of the model
addendum to help mitigate any burden
in developing their own addendum to
meet this requirement.
Additionally, we are finalizing
expansion of the time to complete the
addendum to 5 days in accordance with
the timeframe to complete the
comprehensive assessment. This means
that if a requesting beneficiary dies
within the first 5 days of the hospice
election, hospices would not be
required to complete any requested
addendum as this requirement would be
deemed as being met in this
circumstance. Given that almost 28
percent of beneficiaries die within the
first 5 days of hospice care, this would
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further reduce hospice burden. We have
recalculated the burden estimate in
section IV. of this final rule to account
for the expanded timeframe to complete
the addendum where there would be
fewer eligible elections subject to this
requirement and thus, less burden on
hospices.
We agree with those commenters who
stated that the addendum would be
critical in the care process and would
promote patient empowerment, quality
of care, and transparency. However, we
are not making this a mandatory
requirement for all hospice elections;
we reiterate that the requirement is that
the addendum would be provided only
upon request as we believe this would
best achieve coverage transparency
without imposing undue burden on
hospices. Likewise, because we believe
that hospices should already have
processes in place to make
determinations of unrelatedness,
additional payment should not be made
for completion of the addendum.
Finally, while we recognize that the
addendum, may result in a small
increase in operational burden for some
hospices, we believe this burden is
outweighed by our initiative to put
patients first. We believe that if a
requirement results in promoting
patient choice, autonomy, and coverage
transparency then it is within the
framework of this initiative.
Comment: In addition to the
comments summarized above, we
received numerous comments from
hospices, industry associations, and
other stakeholders who stated concerns
with operational and logistical aspects
of the addendum policy. Furthermore,
commenters wrote that CMS drastically
underestimated the operational
complexity and the impact this
particular requirement would have on
hospice providers and patients.
Generally, commenters had questions
on the logistics of delivering the
addendum to the patient and family
within 48 hours, the clinician who
would be responsible for delivering the
addendum, and whether this would
require the nurse to have a mobile
printer to deliver such information.
Others asked what the expectations
would be when there are changes to the
plan of care after admission; whether
the timeframe is based on when CMS
accepts the election or when the
provider submits the NOE; what
provisions would be made for weekends
and holidays; what education would be
provided to MACs and the BFCC–QIOs
regarding their role in this process; how
CMS would expect evidence that the
unrelated items, services, and drugs
were discussed at admission or at other
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time points during a hospice election;
documentation requirements in the
medical record referencing the
addendum, including who requested
such information and when; what CMS
means when we state that the clinical
rationale should be provided in
‘‘language a beneficiary can
understand’’; how CMS would
determine whether the clinical rationale
is adequately supported; and how
differences between clinical opinion
between the hospice physician and nonhospice providers would be handled.
Response: We realize that commenters
have concerns over some of the
operational and logistical details of
developing and implementing an
addendum to communicate, in writing,
those items, services, and drugs the
hospice will not cover as they have been
determined by the hospice to be
unrelated to the terminal illness and
related conditions. As mentioned
previously, hospices have asked for
additional guidance and details on some
of these issues including the submission
of handwritten versus electronic
signatures, expectations of the type of
documentation expected in the medical
record regarding whether or not the
addendum was requested; what
documentation would be requested by
the MACs when an Additional
Documentation Request (ADR) is made;
whether the addendum could be
provided in an electronic format; the
provision of MAC and BFCC–QIO
education, among others. Some of these
issues have been addressed in previous
responses in this final rule.
Because of some of the issues brought
to light by commenters, we will delay
the effective date for implementation of
the election statement modifications
and the addendum until FY 2021 to
allow additional consideration of these
operational and logistical issues. This
will allow CMS more time to fully
investigate the details brought up by
commenters specifically regarding
operational and auditing processes,
training and education, and we will
engage in rulemaking for FY 2021 as
necessary to seek any additional
comments on any operational or
logistical proposals.
Final Decision: We are finalizing the
election statement modifications as
proposed. We are also finalizing our
proposal that the addendum be titled
‘‘Patient Notification of Hospice NonCovered Items, Services, and Drugs’’
and would include the following
content requirements:
1. Name of the hospice;
2. Beneficiary’s name and hospice
medical record identifier;
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3. Identification of the beneficiary’s
terminal illness and related conditions;
4. 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;
5. 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 would be
accompanied by a general statement that
the decision as to whether or not
conditions, items, services, and drugs is
related is made for each patient and that
the beneficiary should share this
clinical explanation with other health
care providers from which they seek
services unrelated to their terminal
illness and related conditions;
6. References to any relevant clinical
practice, policy, or coverage guidelines.
7. Information on the following
domains:
a. Purpose of Addendum
b. Right to Immediate Advocacy
8. Name and signature of 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.
We are finalizing that the election
statement modifications apply to all
hospice elections but the addendum
only would be furnished to
beneficiaries, their representatives, nonhospice providers, or Medicare
contractors who request such
information. Additionally, we are
finalizing our policy that if the
beneficiary (or representative) requests
an addendum at the time of hospice
election, the hospice would have 5 days
from the start of hospice care to furnish
this information in writing. We are
finalizing our proposal that if the
beneficiary requests the election
statement 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. If the addendum is
requested during the course of hospice
care (that is, after the date of the hospice
election), we are finalizing that the
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hospice would have 72 hours from the
date of the request to provide the
written addendum. We are finalizing
our proposal that the election statement
modifications and the addendum be
effective for hospice elections beginning
on and after October 1, 2020 (that is, FY
2021). As noted previously, we will
continue to examine some of the
operational and logistical issues
highlighted by commenters to determine
if any additional proposals are required
for FY 2021 rulemaking.
At § 418.24(b), we are finalizing the
provisions regarding the election
statement modifications and the
election statement addendum. In
addition, we made several revisions to
§ 418.24. Specifically, we redesignated
paragraphs (c) through (f) as paragraphs
(d) through (g). This redesignation
would affect two cross-references in
§ 418.26(c)(2) and § 418.28(c)(2). As a
result, we made conforming changes to
accompany the redesignations in
§ 418.24. Likewise, at § 418.3, we define
the term BFCC–QIO as the Beneficiary
and Family Centered Care Quality
Improvement Organization. Because
these conforming changes were not
proposed in the proposed rule, we are
adopting them here under a ‘‘good
cause’’ waiver of proposed rulemaking.
The specific changes we are making in
the regulations simply codify the final
policies we described in the proposed
rule and do not reflect any additional
substantive changes.
D. Request for Information Regarding
the Role of Hospice and Coordination of
Care at End-of-Life
In the FY 2020 Hospice Wage Index
and Rate Update proposed rule (84 FR
17598), we solicited public comments
on the interaction of the Medicare
hospice benefit and various alternative
care delivery models, including
Medicare Advantage (MA), Accountable
Care Organizations (ACOs), and other
future models designed to change the
incentives in providing care under
traditional FFS Medicare. We
specifically sought public comments on
how hospice under Medicare FFS
relates to other treatment options, how
it impacts the provision of a spectrum
of care for those that need supportive
and palliative care before becoming
hospice eligible and after, and whether
rates of live discharge are a reflection of
the current structure of Medicare FFS.
We further solicited comments on any
care coordination differences for
hospice patients that received Medicare
through traditional FFS prior to a
hospice election, were enrolled in an
MA plan prior to hospice election, or
received care from providers that
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participate in an ACO prior to a hospice
election.
We appreciate the thoughtful input
and suggestions provided by
commenters in response to this request
for information (RFI). We generally do
not summarize or respond to comments
in the final rule for requests for
information as the purpose of such
requests is to help CMS for future
rulemaking or the development of
models through CMS’ Innovation
Center. However, as we continue to
review the comments received, we
believe that the information gathered
under this RFI will help inform: (1)
Future CMS payment models; (2) the
role of hospice with respect to ACOs;
and (3) our general understanding of the
traditional FFS hospice environment in
relation to the increasing penetration of
managed care through the MA program.
E. Updates to the Hospice Quality
Reporting Program (HQRP)
1. Background and Statutory Authority
The Hospice Quality Reporting
Program includes meeting the reporting
requirements for both the Hospice Item
Set (HIS) and Consumer Assessment of
Healthcare Providers and Systems
(CAHPS®) Hospice Survey. Section
3004(c) of the Affordable Care Act
amended section 1814(i)(5) of the Act to
authorize a quality reporting program
for hospices. 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
for that FY. Depending on the amount
of the annual update for a particular
year, a reduction of 2 percentage points
could result in the annual market basket
update being less than 0 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 particular year involved.
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.
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38521
2. Update to Quality Measure
Development for Future Years
As stated in the FY 2019 Hospice
Wage Index and Payment Rate Update
and Hospice Quality Reporting
Requirements (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. The
Meaningful Measures initiative is not
intended to replace any existing
programs, but will help programs
identify and select individual measures.
The Meaningful Measure Initiative areas
are intended to increase measure
alignment across our programs and
other public and private initiatives.
Additionally, it will point to high
priority areas where there may be gaps
in available quality measures while
helping to guide our efforts to develop
and implement quality measures to fill
those gaps. More information about the
Meaningful Measures initiative can be
found at: https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/
QualityInitiativesGenInfo/MMF/
General-info-Sub-Page.html.
The Meaningful Measures initiative
fits well with the HQRP since it has
changed little since we began with FY
2014 Hospice Wage Index and Payment
Rate Update final rule (76 FR 26806).
The Meaningful Measures initiative
enables us to review the HQRP in order
to close the gaps in quality measures to
reflect the hospice industry as it has
progressed to meet hospice care,
including symptom management for its
patients regardless of where hospice
care is provided.
In the FY 2014 Hospice Wage Index
and Payment Rate Update final rule (78
FR 48257), and in compliance with
section 1814(i)(5)(C) of the Act, we
finalized the specific collection of data
items that support the following 7
National Quality Forum (NQF)-endorsed
measures for hospice:
• 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).
We finalized the following two
additional measures in the FY 2017
Hospice Wage Index and Payment Rate
Update final rule, effective April 1,
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2017. Data collected will, if not
reported, affect payments for FY 2019
and subsequent years. (81 FR 52163
through 52173):
• Hospice Visits when Death is
Imminent,
• Hospice and Palliative Care
Composite Process Measure—
Comprehensive Assessment at
Admission.
The Hospice and Palliative Care
Composite Process Measure—
Comprehensive Assessment at
Admission measure (hereafter referred
to as ‘‘the Hospice 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. Data for the
‘‘Hospice Visits when Death is
Imminent’’ measure pair is being
collected using new items added to the
HIS V2.00.0, effective April 1, 2017.
Our goal is to identify measures that
provide a window into hospice care
throughout the dying process, fit well
with the hospice business model, and
meet the objectives of the Meaningful
Measures initiative. Quality measures
should provide timely, understandable,
comprehensive, clinically valid, and
meaningful feedback to hospice
leadership, all of its staff, and their
different teams regardless of the hospice
setting where care is provided. We
solicited public input on measure
concepts and actual quality measures,
along with public comment on the
discussions presented below.
a. Claims-Based and Outcome Quality
Measure Development for Future Years
As part of Meaningful Measures
initiative, we seek to develop claimsbased and outcome measures as part of
the future for the HQRP. While we
acknowledge that there are limitations
of using claims data as a source for
measure development, there are several
advantages to using claims data as part
of a robust hospice quality reporting
program. Claims-based measures place
minimal burden on providers, as they
do not require additional data collection
and data submission. Furthermore, in
contrast to self-reported data that are
dependent on hospice, patient, or
caregiver participation, claims data has
the benefit of following a relatively
consistent format and of using a
standard set of pre-established codes
that describe specific diagnoses,
procedures, and drugs. Additionally,
nearly every encounter that a patient
has with the healthcare system leads to
the generation of a claim, creating an
abundant and standardized source of
patient information. This makes claims
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data widely available, relatively
inexpensive, and amenable to analysis
because they are readily available in an
electronic format.
Medicare is the largest payer of
hospice services and Medicare-certified
providers predominate in hospice so it
makes good sense to use claims data to
reflect hospice care. Further, other
settings’ quality reporting programs,
such as the Inpatient Quality Reporting
Program (QRP) and the post-acute care
(PAC) QRPs, have adopted claims-based
measures. The NQF has endorsed
claims-based measures and believes
they can capture quality even when not
directly assessing clinical care.
Although claims data have some
limitations, such as incomplete
reflection of care processes and patient
outcomes, they will continue to be a
valuable and important source of data
for quality reporting for a selected set of
metrics and as part of a hospice quality
reporting program that includes other
measures, such as HIS and CAHPS®
Hospice Survey.
While not mutually exclusive of
claims-based measures, we also seek to
develop outcome measures as part of the
Meaningful Measures initiative.
Outcome measures could help with
improving pain management and
symptom management, which are core
to hospice care. They could also help
identify the value of different staff
providing care at different times in
hospice. For these reasons, we plan to
explore the development of other
claims-based and outcome measures for
the HQRP to work toward the high
priority areas of reducing regulatory
burden and identifying gaps in care. In
identifying high priority areas for future
measure enhancement and
development, CMS takes into
consideration input from all
stakeholders including; Measures
Application Partnership (MAP); the
Office of the Inspector General (OIG);
the Medicare Payment Advisory
Commission (MedPAC); Technical
Expert Panels (TEP); issues raised
through the Beneficiary and FamilyCentered Care Quality Improvement
Organization; and national priorities,
such as those established by the
National Priorities Partnership, the HHS
Strategic Plan, the National Strategy for
Quality Improvement in Healthcare, the
CMS Quality Strategy, the Meaningful
Measures initiative and the general
public, such as through rulemaking. In
addition, CMS considers feedback and
input from published research and
reports. We did not propose any new
claims-based or outcome measures at
this time. However, we solicited public
comments and suggestions related to
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ideas for future claims-based and
outcome measure concepts and quality
measures in the HQRP that could also
be tied to the goals of the Meaningful
Measures initiative.
A summary of the comments received
regarding the future claims-based and
outcome measure concepts and our
responses to those comments appear
below:
Comment: Several commenters
support CMS efforts to develop outcome
measures for hospice care. Additionally,
many commenters support using claims
data to develop new measures and cited
the importance of a balanced measure
portfolio comprising different measure
types and data sources. We also
received many comments in support of
using data from the hospice assessment
tool under development to create new
patient and family outcome measures.
Several commenters noted concerns
about using claims data for quality
measurement. Specifically the
commenters noted that claims data only
capture processes and not outcomes of
patient care, and some commenters
stated that the number of visits was not
a good indicator of care quality.
Commenters also stated that claims do
not reflect the full scope of hospice
experience because not all disciplines of
the hospice team, such as volunteers or
spiritual staff, are captured on a claim.
Several commenters stated that claims
data do not provide sufficient
information to adequately represent
hospice practice. Additionally, some
commenters recommended that CMS
modify hospice claims to capture
information on all hospice disciplines
such as chaplain visits.
Response: We appreciate the
commenters’ support for outcome
measure development and reiterate our
commitment to measuring outcomes as
part of the Meaningful Measures
Initiative. We also appreciate the
support for using a future hospice
assessment tool to develop additional
quality measures. We will take these
recommendations under consideration
as we pursue new measure
development.
Regarding the limited focus of claims
data, we refer readers to our discussion
in the FY 2016 Hospice Wage Index and
Payment Rate Update final rule (80 FR
47189) where we address those
concerns regarding claims-based
measures. As previously noted, claimsbased measures place minimal burden
on providers, as they do not require
additional data collection and data
submission, and follow a relatively
consistent format, using standardized
and established coding. Claims-based
measures would be only one type of
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quality measure in the QRP. This is in
line with our efforts to create a broader
set of quality measurement that include
outcome and claims-based measures,
since currently we report measures
based on HIS and CAHPS® Hospice data
that are process and outcome measures.
We will take these comments into
consideration as we continue to address
the high priority areas of identifying
gaps in care and reducing regulatory
burden as we explore the development
of other claims-based and outcome
measures for the HQRP.
b. Update on Claims-Based Measure
Development
The FY 2018 Hospice Wage Index and
Payment Rate Update and Hospice
Quality Reporting Requirements, (82 FR
36638), noted that, based on input from
stakeholders, CMS has identified two
‘‘high priority’’ areas that will be
addressed by claims-based measure
development: Potentially avoidable
hospice care transitions and access to
levels of hospice care. The potentially
avoidable hospice care transitions
concept was developed as a measure
under consideration called ‘‘Transitions
from Hospice Care, Followed by Death
or Acute Care.’’ The goal of this measure
is to identify hospices that have notably
higher rates of live discharges followed
shortly by death or acute care
utilization, when compared to their
peers. Details about this measure can be
found in the FY 2017 Hospice Wage
Index and Payment Rate Update and the
NQF website, https://
www.qualityforum.org/map/, where it
went on the measures under
consideration (MUC) list in July 2018
and was reviewed by the MAP in
December 2018. At this time, we are
revisiting the subject of potentially
avoidable hospice care transitions.
While the MAP did not support the
measure as specified, MAP recognized
the impact that care transitions at the
end of life can have on patients and
suggested a number of ways the MAP’s
concerns with the measure could be
mitigated. Areas that the MAP
recommended included reconsidering
the exclusion criteria for the measure.
Specifically, they recommended that we
review the exclusion for Medicare
Advantage patients, as this may be
excluding too many patients.
Additionally, the MAP suggested adding
an exclusion to allow for patient choice,
as there are a number of reasons a
patient may choose to transition from
hospice. For example, a patient may
choose to pursue additional curative
treatment, have cultural beliefs that
influence the definition of a good death,
have limited access to primary care, or
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may need to revoke the hospice benefit
to avoid a financial penalty for seeking
more acute care. MAP also noted that
the measure may provide more useful
information if it separates out the
concepts addressed in the measure, as
the measure may be trying to address
different concepts by including both
death within 30 days and admission to
an acute care use within 7 days. The
MAP also requested that we consider
shortening the timeframe for the
measure (MAP 2019, ‘‘Considerations
for Implementing Measures in Federal
Programs: Post-Acute Care and LongTerm Care, Final Report’’ February 15,
2019, https://www.qualityforum.org/
WorkArea/linkit.aspx?Link
Identifier=id&ItemID=89400). The
access to levels of hospice care measure
concept is also detailed in the FY 2018
Hospice Wage Index and Payment Rate
Update. After further analyses, it was
determined that this measure concept as
currently specified could result in
hospices providing higher levels of care
when it is not required by the plan of
care or expected by CMS. We remain
committed to developing claims-based
measures that meet high priority areas
and are rethinking both measures based
on feedback from the MAP and our
analyses. We solicited public comments
on ways to further develop these two
measure concepts and different measure
concepts that fall under these high
priority areas. A summary of those
comments and our responses to the
comments appear below:
While commenters supported
measuring potentially-avoidable
transitions and access to levels of care
and agreed that these are high priority
areas, they had several concerns and
suggested modifying the measures,
requested more detail and encouraged
CMS to consider the feedback and
recommendations from the National
Quality Forum’s MAP in 2018 for
modifying the measure specifications.
They also recommended more measure
testing in the measure development to
help gain further support for these
measures.
Comment: Several commenters noted
concerns about how a hospice
transitions measure would capture
patient and family choices to revoke
hospice in favor of other types of
treatment or access to additional
services. They recommended excluding
from the measure live discharges when
the patient elects a different hospice
provider or is discharged for cause, and
noted that patients’ decisions to seek
acute care is outside of a hospice
provider’s control. Some commenters
recommended that claims data capture
the reasons for a live discharge, noting
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there could be many different ones.
Several commenters recommended the
measure be simplified by separating into
two separate measures, as it is
addressing different concepts by
including both death within 30 days
and admission to an acute care use
within 7 days. They also recommended
shortening the measurement period to
create a stronger nexus between the
hospice stay and the adverse event.
Comment: Several commenters noted
that claims data do not sufficiently
reflect the factors that determine
appropriate provision of the various
levels of hospice care and that patient
and caregiver needs vary greatly. They
noted that claims only indicate if the
hospice has billed one of the four levels
of care. They further noted that patient
needs vary and the acuity information
need to evaluate appropriate GIP and
CHC utilization is not available in
claims data. Commenters recommended
looking at interdependent patterns of
care and monitoring for unintended
consequences, such as providing higher
levels of care than needed.
Response: CMS appreciates the
comments and the support for
continuing to refine efforts to measure
these two high priority concepts
identified by the OIG in its 2018 report,
entitled ‘‘Vulnerabilities in the
Medicare Hospice Program Affect
Quality Care and Program Integrity: An
OIG Portfolio’’ and available at https://
oig.hhs.gov/oei/reports/oei-02-1600570.asp. We will take these comments
under advisement as we continue
exploring options for measuring these
constructs and reiterate our
commitment to working with NQF and
the MAP. With respect to potentiallyavoidable transitions, we are carefully
considering stakeholder and MAP
feedback, and are looking at multiple
ways to measure this construct,
including separating out the
components to reduce the measure’s
complexity. In our ongoing
development efforts we are examining
the potential impact of these measures,
including any unintended
consequences.
c. Update on the Hospice Assessment
Tool
We discussed the plan to develop a
hospice assessment tool in the FY 2018
Hospice Wage Index and Payment Rate
Update and Hospice Quality Reporting
Requirements, (82 FR 36638). A
technical expert panel on development
of such an assessment tool was held in
October 2017 followed by a pilot study
that began with training 9 hospice sites
in December 2017. We are sincerely
thankful for and appreciative of the 9
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Medicare hospices that participated in
the pilot study. We learned much from
them during the pilot study and
afterwards in lessons learned
interviews. Information from that pilot
study, referred to as Pilot A, can be
found on the HQRP website at: https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Hospice-Quality-Reporting/
HEART.html. We also discussed Pilot A
findings, lessons learned, and goals of a
hospice assessment tool at the
September 2018 special open door
forum (SODF). The transcript for that
SODF can be found at https://
www.cms.gov/Outreach-and-Education/
Outreach/OpenDoorForums/
PodcastAndTranscripts.html. Key
concepts in developing a hospice
assessment tool include understanding
the care needs of people through the
dying process and ensuring the safety
and comfort of individuals enrolled in
hospice institutions nationwide.
Currently, admission and discharge data
from HIS are used to calculate measures
in the HQRP. We would like to replace
HIS and capture data with a hospice
assessment instrument in order to
develop quality measures and any
possible future payment considerations
to include bridging the gap to achieve a
fuller understanding of patient care
needs. While it must be recognized that
hospice care differs from other PAC
settings, there is a need to create a
comprehensive assessment instrument
for hospice care to align with other PAC
settings, where feasible and practical.
As such, objectives of a comprehensive
assessment instrument must include the
ability to establish goals of care that
embrace the individual’s values and
preferences, and are consistent with a
person-centered approach that values
the person and caregiver in the care
continuum with an emphasis on
physical, psychosocial, spiritual, and
emotional support. We continue our
commitment to engaging stakeholders at
regular SODF meetings and other means
like the HQRP website, open door
forums (ODF), webinars, and other subregulatory means.
One of the requests raised at the
September 2018 SODF was to change
the name of the hospice assessment tool
from Hospice Evaluation Assessment
Reporting Tool (HEART) to a name that
is not as easily confused with other
HQRP related tools like the Hospice
Abstraction Reporting Tool (HART). We
agree with this feedback since people
refer to both by their same sounding
acronyms and solicited public
comments on the name for the hospice
assessment tool.
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We will keep providers informed
about future measure and assessment
tool development efforts and solicit key
stakeholder input through regular subregulatory channels. Additionally,
future measure concepts under
development, including details
regarding measure definitions, data
sources, data collection approaches, and
timeline for implementation will be
communicated in future rulemaking.
Comment: We received several
comments expressing strong support for
the development a new assessment tool
for use in conducting patient
assessments in real-time to assist in the
plan of care and also for developing
future measures to benefit hospice
providers and consumers. These
commenters also appreciated our
ongoing and regular engagement of
stakeholders via sub-regulatory means
in the development process.
Commenters also expressed support
for changing the name and acronym of
an assessment tool, to avoid confusion.
Commenters offered the following
suggestions: Hospice Comprehensive
Assessment Tool or the Comprehensive
Assessment Tool for Hospice; Hospice
Outcomes & Patient Evaluation (HOPE);
Hospice Care Assessment Tool; Hospice
Assessment Tool (HAT); and Evaluation
and Assessment Reporting Tool for
Hospice (EARTH). One commenter
recommended rather than renaming the
HEART (Hospice Evaluation
Assessment Reporting Tool), CMS
rename the Hospice Abstraction
Reporting Tool (HART) to the Hospice
Assessment Software Tool (HAST).
Response: We appreciate the support
for and feedback on developing a new
hospice assessment. We are continuing
the process of developing a new hospice
assessment that meets the objectives of
patient-centered care. This process
includes additional information
gathering, including review of feedback
on the HEART tool, and stakeholder
engagement to develop a draft
instrument for alpha testing that will
ultimately support a national beta test.
We intend to use rule-making to
propose a timeline and process for
implementing the final, tested
assessment tool. We appreciate the
support for wanting to use a new
assessment to development outcome
measures and reiterate our commitment
to providing updates and engaging
stakeholders through sub-regulatory
means.
While HIS is a standardized
mechanism for extracting medical
record data, it is not a patient
assessment instrument that can capture
patient data in real time for use in care
planning. Our goal for a hospice
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assessment tool is to be more
comprehensive than the HIS by
capturing care needs in real-time and
throughout the end of life; not just at
admission and discharge. This includes
flexibility to accommodate patients with
varying lengths of stay. In addition, a
comprehensive assessment tool will
provide standardized data as all
Medicare-certified hospices will be
collecting the same data in standardized
manner. By aligning the assessment
with regular patient care, we intend to
capture baseline data to support care
planning and to inform quality
measurement for the Hospice QRP,
including outcome measures, and to
support providers’ quality improvement
efforts. A new hospice assessment tool
is intended to support quality measure
development and care planning. We
intend to offer training and other
supports as the new tool is being
prepared for implementation; the
timeline for roll-out will be established
through rule-making.
We also appreciate commenter’s
support for changing the name of the
assessment under development. After
reviewing the many great suggestions,
we like the name, Hospice Outcomes &
Patient Evaluation (HOPE). Both the full
name and acronym, HOPE, captures our
goals for this assessment tool. It is a
patient evaluation for use by hospices
and enables CMS to develop outcome
measures that will help consumers in
selecting hospices when publicly
reported. The acronym, HOPE, also
provides the sentiment of hope for
patients achieving the quality of life per
their goals and wishes and supported by
the hospice.
Final Decision: After considering the
comments received in response to the
proposed rule and for the reasons
discussed above, we are finalizing our
proposal to call the hospice assessment
tool the Hospice Outcomes & Patient
Evaluation (HOPE).
3. 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 requires that beginning with the FY
2014 and for 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
for that FY.
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b. Update on the CMS System for
Reporting Quality Measures and
Standardized Patient Assessment Data
and Associated Procedural Issues
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.
We will be migrating to a new internet
Quality Improvement and Evaluation
System (iQIES) as soon as FY 2020 that
will enable us to make real-time
upgrades, and we are designating that
system as the data submission system
for the Hospice QRP. Effective October
1, 2019, we will notify the public of any
changes to the CMS-designated system
in the future using sub-regulatory
mechanisms such as web page postings,
listserv messaging, and webinars. We
solicited public comment on the iQIES
and received no comments.
Final Decision: For the reasons
discussed in the above paragraph, we
will be migrating to the iQIES system as
soon as FY 2020 and will provide
further information regarding the
migration and any future system of
record changes via sub-regulatory
mechanisms to make this transition as
smooth as possible.
4. 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).
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b. Overview of the CAHPS® Hospice
Survey Measures
The CAHPS® Hospice Survey
measures received NQF endorsement on
October 26th, 2016 (NQF #2651). We
adopted these 8 survey based measures
for the CY 2018 data collection period
and for subsequent years. These 8
measures are publicly reported on a
designated CMS website that is
currently Hospice Compare.
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c. Data Sources
We previously finalized the
participation requirements for the FY
2020, FY 2021, and FY 2022 APUs (see
82 FR 36673). We proposed to extend
the same participation requirements for
the HQRP for FY 2023 and all future
years. As part of the Patients Over
Paperwork initiative, we solicited
comments about the CAHPS® Hospice
Survey questionnaire. We solicited
comments regarding suggested changes,
additions or deletions to the instrument
that would improve its value to
hospices for quality improvement and
consumers for selecting a hospice.
A summary of those comments and
our responses to them appear below:
Comment: Some commenters
suggested that the survey was too long,
too complex and duplicative. Other
commenters stated that the language
could be ‘‘friendlier,’’ that the setting of
the patient’s death should determine the
survey questions asked, and that the
survey should be offered in a web-based
version.
Response: We are currently exploring
ways to simplify and shorten the survey
and we are examining the feasibility of
using web-based data collection in
conjunction with traditional survey
methods. In addition, we had a literacylevel review of the questionnaire and
are reviewing what changes may be
feasible to make. When we designed the
survey, we considered allowing the
setting of the patient’s death to
determine the questions. However, the
results from testing showed this would
be burdensome to patients, hospices and
vendors and determined a single survey
would be easier to administer.
Comment: Some commenters
requested changes to the timing of data
collection. Most of the commenters
suggested that we should start data
collection sooner after the death, 45
days instead of a lag of 2 months.
Response: In the initial development
of the survey, the original timeframe for
sending out the survey was trying to
balance respecting the difficult time the
loved one was going through following
the death and not waiting too long after
the hospice services were provided. We
will take this into consideration as we
consider potential changes to the
survey.
Comment: Some commenters stated
that patients’ families do not make a
distinction between the hospice staff
and nursing home/assistance living
facility staff when responding to the
questionnaire.
Response: To help the respondent
make these distinctions, we include
specific references to the hospice
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38525
involved as part of the mail
questionnaire and the telephone
questionnaire script.
Comment: Several commenters
requested a variety of different wording
changes to the questionnaire, including
changes to the response options and the
addition of ‘‘not applicable’’ as a
response. Some commenters stated that
the hospice logo should be included in
mailing packages.
Response: During survey development
we conducted extensive cognitive
interviews with potential respondents to
see if they could understand the
response scales. The respondents had
no problems understanding or using our
response options. We do not need to
include ‘‘not applicable’’ as a response
option because we provide instructions
for skipping inapplicable items. We do
allow hospice logos to be placed on the
questionnaire for mail surveys. Please
refer to the Quality Assurance
Guidelines Manual on the survey
website (www.hospicecahpssurvey.org).
Comment: Some commenters
suggested changes to the survey
exclusions, in particular the exclusion
of patients who have been in hospice
less than 48 hours when they died. In
addition, several commenters stated that
we should ‘‘give credit’’ for the response
of ‘‘usually,’’ as there may be persons
who are uncomfortable with absolutes
such as ‘‘always.’’ A few commenters
suggested the inclusion of questions
specifically about veterans and to use
ethnicity as a case-mix adjustment
factor.
Response: The reason we excluded
patients who die within 48 hours is
because we were concerned that
caregivers did not have enough
experience with the hospice to provide
informed responses to the survey. We
do publicly report the results including
responses of ‘‘usually’’. We determined
that we would not require the inclusion
of questions specifically about veterans
because it would make the survey even
longer. We also note that among our
case-mix adjustments are variables for
the language in which the survey was
administered, along with the language
the caregiver reports speaking at home.
The goal of case-mix adjustment is to
adjust for differences in patient or
caregiver characteristics that impact
response tendencies. We generally do
not adjust for race and ethnicity in order
to not mask true differences in the
quality of care across racial and ethnic
groups.
Comment: Several commenters stated
that we should take into consideration
hospice characteristics, including rural
versus urban, and hospice size.
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Response: We publicly report hospice
size. We consider a variety of variables,
including urban and rural
characteristics, when looking at quality
measures. Internal analysis of our data
shows that approximately eight in ten
hospices that report CAHPS data are
urban and about two in ten are rural.
Please note that rural hospices may be
more likely to qualify for size
exemptions and therefore may not
participate in the CAHPS® Hospice
Survey.
Final Decision: We appreciate the
feedback on potential changes to the
CAHPS® Hospice Survey and will take
these comments into consideration as
we consider changes. Any potential
changes will be proposed through future
rulemaking.
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. We report 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. We refresh the data 4
times a year in the months of February,
May, August, and November.
e. Volume-Based Exemption for
CAHPS® Hospice Survey Data
Collection and Reporting Requirements
We previously finalized a volumebased exemption for CAHPS® Hospice
Survey Data Collection and Reporting
requirements in the FY 2017 Hospice
Wage Index and Payment Rate Update
final rule (82 FR 36671). We proposed
to continue our policy for a volumebased exemption for CAHPS® Hospice
Survey Data Collection for FY 2021 and
every year thereafter. For example, for
the FY 2021 APU, hospices that have
fewer than 50 survey-eligible decedents
or caregivers in the period from January
1, 2018 through December 31, 2018
(reference year) are eligible to apply for
an exemption from CAHPS® Hospice
Survey data collection and reporting
requirements (corresponds to the CY
2019 data collection period). To qualify,
hospices must submit an exemption
request form for the FY 2021 APU. The
exemption request form is available on
the official CAHPS® Hospice Survey
website: https://
www.hospiceCAHPSsurvey.org.
Hospices that intend to claim the size
exemption are required to submit to
CMS their completed exemption request
form covering their total unique patient
count for the reference year (for the CY
2019 data collection period the
reference year is January 1, 2018
through December 31, 2018). The due
date for submitting the exemption
request form for the FY 2021 APU is
December 31, 2019. Exemptions for size
are active for 1 year only. If a hospice
continues to meet the eligibility
requirements for this exemption in
future FY APU periods, the organization
needs to request the exemption annually
for every applicable FY APU period by
the final day of the calendar year.
Subsequent periods will follow the
same pattern of using the year before the
data collection year as the reference year
for determining eligibility.
Starting with FY 2022, we proposed
to provide an automatic exemption to
any hospice that (1) is an active agency
and (2) according to CMS data sources
has served less than a total of 50 unique
decedents in the reference year. The
automatic exemption is good for 1 year
and will be reassessed in subsequent
years. Hospices with fewer than 50
unique decedents in the reference year
would not be required to submit an
exemption request form.
Hospices that have a total patient
count of more than 50 unique decedents
in the reference year, but that have a
total of fewer than 50 survey-eligible
decedent/caregiver pairs, will not be
granted an automatic exemption.
However, hospices may qualify to apply
for a size exemption if they have fewer
than 50 survey-eligible decedent/
caregiver pairs (for example, if a patient
dies in hospice care less than 48 hours
after admission, they and their caregiver
is not considered to be survey-eligible).
Similarly, if a caregiver has an address
outside the United States (U.S.) and its
possessions, then that decedent/
caregiver pair is not survey-eligible.
Hospices may apply for a size
exemption by submitting the size
exemption request form as outlined
above. This exemption is valid for 1
year only. If the hospice remains eligible
for the size exemption, it must request
the exemption annually for every
applicable FY APU period. We solicited
feedback on these proposals.
TABLE 14—SIZE EXEMPTION KEY DATES FY 2021 THROUGH FY 2025
Data
collection
year
Fiscal year
FY
FY
FY
FY
FY
2021
2022
2023
2024
2025
.........................................................................................................................
.........................................................................................................................
.........................................................................................................................
.........................................................................................................................
.........................................................................................................................
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f. Newness Exemption for CAHPS®
Hospice Survey Data Collection and
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
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2019
2020
2021
2022
2023
38642), we continued the newness
exemption for FY 2023, FY 2024, FY
2025, and all future years. We encourage
hospices to keep the letter they receive
providing them with their 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
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Reference
year
2018
2019
2020
2021
2022
Size exemption form
submission deadline
December
December
December
December
December
31,
31,
31,
31,
31,
2019.
2020.
2021.
2022.
2023.
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 proposed to continue those
requirements in all subsequent years.
Below we reprint the Hospice Survey
data submission dates finalized in the
FY 2019 Hospice Wage Index and
Payment Rate Update final rule (83 FR
38643).
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TABLE 15—CAHPS® HOSPICE SURVEY DATA SUBMISSION DATES FOR THE APU IN FY 2023, FY 2024, AND FY 2025
CAHPS® quarterly data
submission deadlines **
Sample months
(month of death) *
FY 2023 APU
CY
CY
CY
CY
January–March 2021 (Quarter 1) ...................................................................................................................................
April–June 2021 (Quarter 2) ...........................................................................................................................................
July–September 2021 (Quarter 3) ..................................................................................................................................
October–December 2021 (Quarter 4) ............................................................................................................................
August 11, 2021.
November 10, 2021.
February 9, 2022.
May 11, 2022.
FY 2024 APU
CY
CY
CY
CY
January–March 2022 (Quarter 1) ...................................................................................................................................
April–June 2022 (Quarter 2) ...........................................................................................................................................
July–September 2022 (Quarter 3) ..................................................................................................................................
October–December 2022 (Quarter 4) ............................................................................................................................
August 10, 2022.
November 9, 2022.
February 8, 2023.
May 10, 2023.
FY 2025 APU
CY
CY
CY
CY
January–March 2023 (Quarter 1) ...................................................................................................................................
April–June 2023 (Quarter 2) ...........................................................................................................................................
July–September 2023 (Quarter 3) ..................................................................................................................................
October–December 2023 (Quarter 4) ............................................................................................................................
August 9, 2023.
November 8, 2023.
February 14, 2024.
May 80, 2024.
* Data collection for each sample month initiates 2 months following the month of patient death (for example, in April for deaths occurring in
January).
** Data submission deadlines are the second Wednesday of the submission months, which are the months August, November, February, and
May.
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
hospiceCAHPSsurvey@HCQIS.org or
call 1 (844) 472–4621.
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5. 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 a hospice has the opportunity to
review the data that is to be made public
prior to such data being made public;
the data will be available on our public
website. To meet the Act’s requirement
for making quality measure data public,
we launched the Hospice Compare
website in August 2017. This website
allows consumers, providers, and other
stakeholders to search for all Medicarecertified hospice providers and view
their information and quality measure
scores. Since its release, the CMS
Hospice Compare website has reported
7 HIS Measures (NQF #1641, NQF
#1647, NQF #1634, NQF #1637, NQF
#1639, NQF #1638, and NQF #1617). In
February 2018, CAHPS® Hospice
Survey measures (NQF #2651) were
added to the website, and in November
2018, the Hospice and Palliative Care
Composite Process Measure—
Comprehensive Assessment at
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Admission (NQF #3235) was added to
the website; please see the following
rules where these topics were discussed,
FY 2016 Hospice Wage Index and
Payment Rate Update (80 FR 47199); FY
2017 Hospice Wage Index and Payment
Rate Update (81 FR 52184); FY 2018
Hospice Wage Index and Payment Rate
Update (82 FR 36675); and FY 2019
Hospice Wage Index and Payment Rate
Update (83 FR 38640).
b. Update to ‘‘Hospice Visits when
Death is Imminent’’ Measure To Be
Publicly Displayed in August 2019
1. Background and Description of
‘‘Hospice Visits when Death is
Imminent’’ Measure Pair
In the FY 2017 Hospice Wage Index
and Payment Rate Update (81 FR 52163
to 52169, August 6, 2016), we finalized
the ‘‘Hospice Visits when Death is
Imminent’’ measure pair for
implementation April 1, 2017. This
measure pair assesses whether the needs
of hospice patients and their caregivers
were addressed by the hospice staff
during the last days of life. The
‘‘Hospice Visits when Death is
Imminent’’ measure pair is made up of
two measures, Measure 1 and Measure
2. Measure 1 of the pair assesses the
percentage of patients receiving at least
1 visit from a registered nurse,
physician, nurse practitioner, or
physician assistant in the last 3 days of
life. Measure 2 assesses the percentage
of patients receiving at least 2 visits
from social workers, chaplains or
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spiritual counselors, licensed practical
nurses, or aides in the last 7 days of life.
2. Update to Public Reporting of the
‘‘Hospice Visits when Death is
Imminent’’ Measure Pair
As stated in the FY 2019 Hospice
Wage Index and Payment Rate Update
and Hospice Quality Reporting
Requirements (83 FR 38643 through
38645, August 6, 2018), quality
measures are publicly reported on
Hospice Compare or other CMS
websites once they meet the readiness
standards for public reporting, which is
determined through rigorous testing for
reliability, validity, and reportability.
Since the proposal of the ‘‘Hospice
Visits when Death is Imminent’’
measure pair, we have conducted
further measure testing activities
according to NQF guidelines and the
Blueprint for the CMS Measures
Management System Version 14.0
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/MMS/
Downloads/BlueprintVer14.pdf. This
testing is conducted to ensure that
measures demonstrate scientific
acceptability (including reliability and
validity) and meet the goals of the
HQRP, which include distinguishing
performance among hospices and
contributing to better patient outcomes.
As we assessed the scientific
acceptability of ‘‘Hospice Visits when
Death is Imminent’’ measure pair, we
determined that Measure 1 meets
established standards for reliability,
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validity, and reportability. Therefore,
the measure is being publicly reported
as stated in the FY 2019 Hospice Wage
Index and Payment Rate Update and
Hospice Quality Reporting
Requirements (83 FR 38645 through
38648). Our testing of Measure 2 of the
‘‘Hospice Visits when Death is
Imminent’’ measure pair (referred to as
Measure 2) revealed that the measure
did not meet readiness standards for
public reporting and additional testing
was needed before we could make a
decision on the public reporting of
Measure 2. Therefore, we decided not to
publish Measure 2 of the ‘‘Hospice
Visits when Death is Imminent’’
measure pair. See our discussion on our
website: https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/HospiceQuality-Reporting/Public-ReportingBackground-and-Announcements.html
for more information.
Although Measure 2 will not be
publicly reported, we believe that
Measure 2 focuses on an important
aspect of quality care for imminently
dying patients. Therefore, we will
include quality performance data on the
measure in each hospice’s confidential
Quality Measure Reports and the
Review and Correct Report available on
the Certification and Survey Provider
Enhanced Reporting (CASPER) system.
Hospices will also still receive credit for
reporting on Measure 2 as part of the
HQRP requirements. Furthermore,
Measure 2 aligns with our Meaningful
Measures initiative and its quality
priorities, particularly ‘‘Strengthen
Person and Family Engagement as
Partners in Their Care—End of Life Care
according to Preferences.’’ While
Measure 1 of the ‘‘Hospice Visits when
Death is Imminent’’ measure pair
(referred to as Measure 1) addresses case
management and clinical care, Measure
2, which includes visits from social
workers, chaplains or spiritual
counselors, licensed practical nurses,
and aides, recognizes providers’
flexibility to provide individualized
care from a variety of disciplines that is
in line with the patient, family, and
caregiver’s preferences and goals for
care and contributes to the overall wellbeing of the individual and others
important to them at the end of life. As
such, we believe that Measure 2
addresses a high-priority measure area
where there is significant opportunity
for improvement, as well as is
meaningful to patients, clinicians, and
providers alike.
We will conduct additional testing on
Measure 2 to determine if and how the
measure specifications may be modified
or re-specified, and if the method for
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displaying the measure may be adjusted,
so that this measure meets the highest
standards of scientific acceptability and
reportability. Additional testing will
also ensure that Measure 2 is thoroughly
evaluated to determine that it meets the
criteria for public reporting.
The results of the additional testing
will inform the next steps regarding the
public reporting of Measure 2 of
‘‘Hospice Visits when Death is
Imminent’’ measure pair. As stated in
the FY 2019 Hospice Wage Index and
Payment Rate Update and Hospice
Quality Reporting Requirements (83 FR
38643), we will inform providers of
updates to testing and public reporting
of quality measures, including Measure
2 of the ‘‘Hospice Visits when Death is
Imminent’’ measure pair, through subregulatory channels and regular HQRP
communication strategies, such as Open
Door Forums, Medicare Learning
Network, CMS.gov website
announcements, listserv messaging, and
other opportunities. We will announce
any policy changes through the notice
and comment rulemaking process.
Our decision not to publicly report
Measure 2 of the ‘‘Hospice Visits when
Death is Imminent’’ measure pair at this
time is distinct from our interest in
continuing collecting these data.
Specifically, these data are needed to
determine whether a measure meets all
the criteria for public reporting.
Continued data collection will enable us
to test and modify or re-specify a
measure so that these criteria are
satisfied. We seek to balance these data
collection effort with the section
1814(i)(5)(E) of the Act, which states,
‘‘The Secretary shall report quality
measures that relate to hospice care
provided by hospice programs on the
internet website of the Centers for
Medicare & Medicaid Services.’’ We
believe that information required for the
robust analyses to further develop this
measure, modify or re-specify it to allow
for public reporting justifies continuing
data collection.
The data collection and submission
requirements for the ‘‘Hospice Visits
When Death is Imminent’’ measure pair
will not change in order to collect the
data for measure 1, which will be
publicly reported beginning with FY
2019. Measure 2, which will not be
publicly reported at this time, needs to
be further evaluated for modification or
re-specification. Measure 2 of ‘‘Hospice
Visits when Death is Imminent’’
measure pair is calculated using items
O5010, O5020 and O5030 from the HIS
V2.00.0. These items collect data on
hospice visits in the final 3 days of life,
level of care in the final 7 days of life,
and hospice visits in the three to six
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days prior to death. Because the
measure is not being removed from the
HQRP, providers should continue to
complete these items accurately and
completely and submit HIS records to
us in a timely manner. We require data
from Section O to calculate Hospice
Visits when Death is Imminent Measure
1, which will be publicly reported
beginning in August 2019. Therefore,
we proposed continued collection of
this data to complete additional testing
and to make a determination about the
public reporting of Measure 2 of the
‘‘Hospice Visits when Death is
Imminent’’ measure pair. We expect to
complete our analysis by the end of FY
2020, and determine next steps for
public reporting based on meeting
established standards for reliability,
validity, and reportability.
We are cognizant and respectful of the
time and effort that hospices take to
complete the HIS V2.00.0 items used to
calculate and test Measure 2. We will
continually evaluate the volume and
robustness of the resulting data to
determine when data collection is no
longer required.
Comments: We received support from
several commenters for our proposal to
continue data collection of relevant data
to support testing through September
30, 2020. We also received support for
continued testing of Measure 2 of the
‘‘Hospice Visits when Death is
Imminent’’ measure pair to evaluate if it
should be publicly-reported.
Some commenters also confirmed the
value of visit information for quality
purposes. In addition, commenters
provided suggestions for modifying
Measure 2. These included addressing
higher levels of care and short lengths
of stay, including RN visits in the
definition, and capturing whether
patients and their families declined a
visit during the last days of life,
potentially through skip logic. Some
commenters stated that Measure 1 and
Measure 2 were paired metrics that
should be reported together. A few
commenters noted location of care and
rural versus urban settings as factors
that could affect measure results.
Response: We appreciate the
commenters’ feedback and support for
our plans to continue data collection
and testing to assess options for assuring
this measure meets the highest
standards of scientific acceptability and
reportability for public reporting. We
intend to consider commenters’ specific
suggestions during our testing process
for this quality measure. We note that
we do include urban and rural issues
and location of care as we develop,
modify, or re-specify this and other
measures. Overall, we have found that
E:\FR\FM\06AUR3.SGM
06AUR3
there is no statistical difference between
the visits in urban versus rural locations
and this is further supported by the
literature 39 that supports this position.
The two visit measures are referred to
as paired because they relate to the same
topic of measuring visits in the last days
of life by hospice disciplines. However,
the measures are independent
constructs and can be reported
separately. The measures are each
developed using different number of
visits and different hospice disciplines.
They are unique measures that each
provide useful and distinct information
for separate public reporting.
Final Decision: After considering the
comments received in response to the
proposed rule and for the reasons
discussed in the above paragraph, we
are finalizing our proposal to continue
collection of this data to complete
additional testing and to make a
determination about the public
reporting of Measure 2 of the ‘‘Hospice
Visits when Death is Imminent’’
measure pair. We expect to complete
our analysis by the end of FY 2020, and
determine next steps for public
reporting based on meeting established
standards for reliability, validity, and
reportability. We will continue to use a
variety of sub-regulatory channels and
regular HQRP communication strategies,
such as Open Door Forums, Medicare
Learning Network, CMS.gov website
announcements, listserv messaging, and
other opportunities, to provide ongoing
updates of testing results and our plans
for modifying and reporting this
measure.
39 Teno JM, Plotzke M, Christian T, Gozalo P.
Examining Variation in Hospice Visits by
Professional Staff in the Last 2 Days of Life. JAMA
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c. Display of Publicly Available
Government Data Along With CMS and
Medicare Hospice Related Data as
Information for Public Reporting
1. Update To Posting of Public Use File
(PUF) Data as Information for Public
Reporting
38529
Quality Reporting Requirements (83 FR
38649), we finalized plans to publicly
post information from the Medicare
Provider Utilization and Payment Data:
Physician and Other Supplier Public
Use File (PUF) and other publicly
available CMS data to the Hospice
Compare or other CMS website. This
PUF data, along with clear text
explaining the purpose and uses of this
information and suggesting consumers
discuss this information with their
healthcare provider, displayed under a
new section on Hospice Compare in
May 2019. This new section precede the
existing ‘‘Family Experience of Care’’
section on the Hospice Compare
website. Tables 16 through 18 show
how these data displayed on Hospice
Compare.
BILLING CODE 4120–01–P
In the FY 2019 Hospice Wage Index
and Payment Rate Update and Hospice
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Intern Med. 2016;176(3):364–370. doi:10.1001/
jamainternmed.2015.7479
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ER06AU19.035</GPH>
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Table 17: Mock-up of Primary Diagnosis Information on Hospice Compare
Medical
Conditions
Cancer
Dementia
Stroke
Heart Disease
Respiratory
Disease
Other
Hospice A
Average Daily
Census: 345
Date Certified:
04/0111995
Hospice B
Average Daily
Census: 67
Date Certified:
04/01/2002
18.3%
45.5%
Less than 11
patients
17.8%
Less than 11
patients
National
Average
Average Daily
Census: 74
45.6%
20.7%
18.9%
Hospice C
Average Daily
Census: Not
available
Date
Certified:
04/0112017
Not Available
Not Available
Not Available
17.0%
Not Available
Not Available
20.8%
11.9%
Not Available
16.1%
Less than 11
patients
27.3%
21.1%
9.4%
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Note: InformatiOn IS "Not Avmlable" for Hospice C because the hospice was Medicare-certified m
2017. PUF data currently are only available through 2016. "Less than 11 patients" indicates the
hospice served less tllan 11 patients witll tlle indicated condition in 20 16. Data for hospice providers
who served between 0 and 11 patients with a particular condition is not reported in the PUF to protect
personal healtll information and ensure publicly reported data is a reliable indication of services
provided by the hospice.
BILLING CODE 4120–01–C
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2. Posting Information From
Government Data Sources as
Information for Public Reporting
As part of our ongoing efforts to make
public reporting more meaningful and
informative to our beneficiaries, their
caregivers, and families, we propose to
publicly post information that utilizes
publicly available government data from
other agencies, in addition to the data
from the PUF or other CMS or Medicare
sources, at some time in the future. We
propose to use comparative and
complementary data from other
government sources as part of public
reporting on Hospice Compare or other
CMS websites in the future and as soon
as FY 2020. Examples include
information compiled by the U.S.
Census Bureau, Centers for Disease
Control and Prevention, Bureau of Labor
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Statistics, and National Institutes of
Health.
We may use information available in
these public government files to
augment the section described above.
This section including PUF data and
information from other public
government data will provide additional
information along with the HQRP
measures currently from the HIS and
CAHPS® quality measures that are
already displayed.
Any future reporting of public
government data as information for
public reporting will be displayed in a
consumer-friendly format on Hospice
Compare or other CMS website. This
means we may display the data as
shown in these publicly available
government files or present the data
after additional calculations. For
example, the data could be averaged
over multiple years, displayed as a
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38531
percentage rather than the raw number,
or other calculations could be based on
a given year or over multiple years, so
the data has meaning to end-users.
Furthermore, by performing these
calculations, we can make the data
apply to hospices broadly regardless of
size, location, or other factors.
Also, we would like to note that data
used from these publicly available
sources are not quality measures.
Rather, they present supplementary
information that many consumers seek
during the provider selection process
and, therefore, will help them to make
an informed decision. This is similar to
other useful information we already
publicly display under the Spotlight,
Tools and Tips, and Additional
Information sections on the Hospice
Compare homepage. Data from publicly
available data sources can serve as one
more piece of information, along with
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quality of care metrics from the HIS and
CAHPS® Hospice Survey and other
useful information, to help consumers
effectively and efficiently compare
hospice providers and make an
informed decision about their care in a
stressful time. We also believe such
information may be useful to providers.
For example, adding data as information
from the U.S. Census Bureau in
coordination with this service area from
Medicare claims data may help
consumers better understand the service
area in which they are looking for
services (for example, if there is a large
population of people from a similar race
or ethnicity in the area). This
information may also help providers
better understand their service area to
see if there are any business
development opportunities (for
example, if there is a large population
of a similar race or ethnicity, the
provider may consider investing
resources in better serving patients from
this background).
To ensure that end-users understand
that these data provide information
about hospice characteristics and are
not a reflection of the quality of care a
hospice provides, we will, with
consultation from key stakeholders,
carefully craft explanatory language to
ensure that consumers understand the
information and how the data are meant
for informational purposes only.
As we determine which publicly
available government data sources we
will use and how we will be using and
presenting information from these
sources, we will inform the public and
engage with stakeholders via subregulatory processes, including regular
HQRP communication strategies such as
Open Door Forums, Medicare Learning
Network, Spotlight Announcements,
and other opportunities.
We solicited public comment on our
proposal to post information from
publicly available government sources
for public reporting in the future.
A summary of those comments and
our responses to them appear below:
Comment: Overall commenters
supported publicly posting contextual
government information to supplement
the already posted CMS and Medicare
public data, but several requested more
detail on the specific information for
posting data from other U.S. government
websites and how it would be used.
Some commenters recommended that
there be a correlation between any other
U.S. government data and the quality of
hospice care or meaningful context of
hospice and questioned the sources
noted. They also recommended seeking
stakeholder input prior to adding
information for public reporting and
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making sure any posted information was
clearly explained.
Response: We appreciate the
commenters’ support and request for
more detail about any additional data
from public other U.S. government
websites under consideration for
posting publicly. We confirm our
commitment to using sub-regulatory
processes for soliciting and receiving
ongoing stakeholder information and
feedback as we develop these data. As
part of this effort, we will provide mockups of the data for stakeholder feedback
and show the relationship between the
data from other U.S. government
websites and hospice related data. The
goal is for the information to help
consumers in comparing providers. We
reiterate our intent to conduct plain
language testing, including
distinguishing this information from
quality data.
Final Decision: After considering the
comments received in response to the
proposed rule and for the reasons
discussed in the above paragraph, we
are finalizing our proposal to post
information from other publiclyavailable U.S. government sources to
publicly report in the future and as soon
as FY 2020 on Hospice Compare or
other CMS website.
IV. Waiver of Proposed Rulemaking
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment
before the provisions of a rule take effect
in accordance with section 553(b) of the
Administrative Procedure Act (APA) (5
U.S.C. 553(b)). However, we can waive
this notice and comment procedure if
the Secretary finds, for good cause, that
the notice and comment process is
impracticable, unnecessary, or contrary
to the public interest, and incorporates
a statement of the finding and the
reasons therefore in the rule. This
hospice proposed rule has previously
been subjected to notice and comment
procedures. These corrections do not
make substantive changes to this policy.
Specifically, we redesignated
paragraphs (c) through (f) as paragraphs
(d) through (g). This redesignation
would affect two cross-references in
§ 418.26(c) (2) and § 418.28(c) (2). As a
result, we made conforming changes to
accompany the redesignations in
§ 418.24. Likewise, at § 418.3, we define
the term BFCC–QIO as the Beneficiary
and Family Centered Care Quality
Improvement Organization. Because
these conforming changes were not
proposed in the proposed rule, we are
adopting them here under a ‘‘good
cause’’ waiver of proposed rulemaking.
The specific changes we are making in
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the regulations simply codify the final
policies we described in the proposed
rule and do not reflect any additional
substantive changes. Therefore, we find
that undertaking further notice and
comment procedures to incorporate
these corrections into the final rule is
unnecessary and contrary to the public
interest.
V. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 30day 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.
Section 1814(i)(5)(C) of the Act
requires that each hospice submit data
to the Secretary on quality measures
specified by the Secretary. This data
must be submitted in a form and
manner, and at a time specified by the
Secretary.
We solicited public comment on each
of these issues for the following sections
of this document that contain
information collection requirements
(ICRs):
A. Election Statement Addendum:
‘‘Patient Notification of Hospice NonCovered Items, Services, and Drugs’’
To calculate this burden estimate, we
use salary information from the Bureau
of Labor Statistics (BLS) website at
https://www.bls.gov/ and include a
fringe benefits package worth 100
percent of the base salary. The mean
hourly wage rates are based on May,
2018 BLS data for each discipline. Table
19 contains our burden estimate
assumptions for the proposed Election
Statement Addendum: ‘‘Patient
Notification of Hospice Non-Covered
Items, Services, and Drugs’’ discussed in
section III.C. of this final rule. The
required addendum would not be
required until FY 2021; that is, the
addendum would be required, upon
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request, for those hospice elections
beginning on or after October 1, 2020.
This burden estimate represents what
the estimated costs would be if
implemented in FY 2020. We will re-
estimate this burden in the FY 2021
proposed rule using more recent claims
data to more accurately reflect costs for
FY 2021 implementation. For the
purposes of this estimate, we are
38533
assuming that all beneficiaries electing
the hospice benefit, and who do not die
within the first 5 days of care, would
request the addendum.
TABLE 19—ELECTION STATEMENT ADDENDUM: ‘‘PATIENT NOTIFICATION OF HOSPICE NON-COVERED ITEMS, SERVICES,
AND DRUGS’’ BURDEN ESTIMATE ASSUMPTIONS
Number of Medicare-billing hospices, from FY 2017 Medicare Enrollment Database, Provider of Service
files.
Number of hospice elections in FY 2017 .........................................................................................................
Hourly rate of an office employee (Executive Secretaries and Executive Administrative Assistants, 43–
6011).
Hourly rate of an administrator (General and Operations Managers, 11–1021) ..............................................
Hourly rate of registered nurses (Registered Nurses, 29–1141) ......................................................................
Hourly rate of pharmacy technicians (Pharmacy Technicians, 29–2052) ........................................................
4,465.
(1,268,497 × 0.72) = 913,318.
$59.18 ($29.59 × 2.00).
$119.12 ($59.56 × 2.00).
$72.60 ($36.30 × 2.00).
$32.70 ($16.35 × 2.00).
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Source: FY 2017 hospice claims data. 28 percent of beneficiaries die within the first 5 days of hospice care. Hospices are exempt for completing addendum if beneficiary dies within first the first 5 days of care.
Section 1814(a) (7) of the Act requires
for the first 90-day period of a hospice
election the individual’s attending
physician (as defined in section
1861(dd)(3)(B) of the Act) (which for
purposes of this subparagraph does not
include a nurse practitioner), and the
medical director (or physician member
of the interdisciplinary group described
in section 1861(dd)(2)(B) of the Act) of
the hospice program providing (or
arranging for) the care, each certify in
writing, at the beginning of the period,
that the individual is terminally ill (as
defined in section 1861(dd)(3)(A) of the
Act). The regulations codified at
§ 418.22 and § 418.25 provide the
requirements regarding the certification
of terminal illness and admission to
hospice care. The hospice medical
director must specify that the
individual’s prognosis is for a life
expectancy of 6 months or less if the
terminal illness runs its normal course.
Additionally, clinical information and
other documentation that support the
medical prognosis must accompany the
certification and must be filed in the
medical record with the written
certification. The physician must
include a brief narrative explanation of
the clinical findings that supports a life
expectancy of 6 months or less as part
of the certification. The aforementioned
regulations also require that the hospice
medical director must consider both
related and unrelated conditions and
current clinically relevant information
when making the decision to certify the
individual as terminally ill. Likewise,
the hospice CoPs at § 418.102(b) provide
the requirements regarding the
certification responsibility of the
hospice medical director or hospice
physician designee which includes a
review of the clinical information,
including both related and unrelated
conditions, for each hospice patient.
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In order to receive hospice services
under the Medicare hospice benefit,
eligible beneficiaries must elect to
receive hospice care by completing an
election statement. By signing this
election statement, the individual
acknowledges that he or she waives all
rights to Medicare payments for
treatment related to the terminal illness
and related conditions. The content
requirements for the hospice election
statement are listed at § 418.24(b) and
each hospice election statement must
include the following information:
(1) Identification of the particular
hospice and of the attending physician
that will provide care to the individual.
The individual or representative must
acknowledge that the identified
attending physician was his or her
choice.
(2) The individual’s or
representative’s acknowledgement that
he or she has been given a full
understanding of the palliative rather
than curative nature of hospice care, as
it relates to the individual’s terminal
illness.
(3) Acknowledgement that certain
Medicare services, as set forth in
§ 418.24(d) of this section, are waived
by the election.
(4) The effective date of the election,
which may be the first day of hospice
care or a later date, but may be no
earlier than the date of the election
statement.
(5) The signature of the individual or
representative.
Once a beneficiary is certified as
terminally ill and elects the Medicare
hospice benefit, the hospice conducts an
initial assessment visit in advance of
furnishing care. During this visit, the
hospice must provide the patient or
representative with verbal and written
notice of the patient’s rights and
responsibilities as required by the CoPs
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at § 418.52. Likewise, the regulations at
§ 476.78 state that providers must
inform Medicare beneficiaries at the
time of admission, in writing, that the
care for which Medicare payment is
sought will be subject to Quality
Improvement Organization (QIO)
review.
The beneficiary needs identified in
the initial and comprehensive
assessments drive the development and
revisions of an individualized written
plan of care for each patient as required
by the hospice CoPs at § 418.56. The
hospice plan of care is established,
reviewed and updated by the hospice
IDG and must include all services
necessary for the palliation and
management of the terminal illness and
related conditions. While needs
unrelated to the terminal illness and
related conditions are not the
responsibility of the hospice, the
hospice may choose to furnish services
for those needs regardless of
responsibility. However, if a hospice
does not choose to furnish services for
those needs unrelated to the terminal
illness and related conditions, the
hospice is to communicate and
coordinate with those health care
providers who are caring for the
unrelated needs, as described in
§ 418.56(e). In accordance with the
CoPs, the hospice must document the
services and treatments that address
how they will meet the patient and
family-specific needs related to the
terminal illness and related conditions
in the plan of care, and those needs
unrelated to the terminal illness and
related conditions that are present when
the patient elects hospice should also be
documented. This documentation
ensures that the hospice is aware of
those unrelated needs and who is
addressing them. This documentation
provides the support for the hospices’
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financial responsibility for the hospice
services they will be providing. There is
limited beneficiary financial liability for
hospice services upon election of the
Medicare hospice benefit. However, for
any services received that are unrelated
to the terminal illness and related
conditions, the beneficiary would incur
any associated copayments and
coinsurance.
Hospices already are required to
review, determine, and document
information on unrelated conditions in
accordance with the hospice regulations
and CoPs. However, to ensure Medicare
beneficiaries are provided disclosure of
those conditions, items, services, and
drugs the hospice has determined to be
unrelated to the terminal illness and
related conditions at the time of
admission, we are finalizing additions
to the regulations at § 418.24(b) and (c)
for FY 2021, which will require an
election statement addendum titled
‘‘Patient Notification of Hospice NonCovered Items, Services, and Drugs’’
that must be issued, on request, to the
patient (or representative) within 5 days
of the hospice election date to ensure
that Medicare beneficiaries are fully
informed whether or not all items,
services, and drugs identified on the
hospice plan of care will be furnished
by the hospice. The addendum
statement would not be required if the
beneficiary died within 5 days of the
hospice election date. This addendum
would accompany the hospice election
statement and each hospice would use
the required proposed elements to
develop and design their own
addendum to best meet their needs and
the requirement. This requirement for
payment would be added to the
regulations at § 418.24(b) and (c)
effective for hospice elections beginning
on and after October 1, 2020.
The burden associated with the
documentation requirement for the
addendum includes the time for each
hospice to develop the addendum that
the hospice provides to the beneficiary
(or their representative) within 5 days of
election of the Medicare hospice benefit.
The addendum must include the name
of the issuing hospice, beneficiary’s
name, and hospice medical record
identifier. The addendum must also
allow the hospice registered nurse to
document a list of non-covered
conditions and associated items,
services, and drugs, as well as provide
a clinical explanation as to why these
conditions and associated items,
services, and drugs have been
determined to be unrelated to the
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terminal illness and related conditions.
This documentation would include
references to any relevant clinical
practice, policy, or coverage guidelines.
The addendum must include statements
informing the patient as to the purpose
of the addendum and information on
BFCC–QIO Immediate Advocacy rights
and contact information. The addendum
would be signed by the beneficiary as an
acknowledgement that he or she has
received this information, but signing it
does not mean the beneficiary agrees
with the determination. We believe that
the burden for the hospice associated
with the election statements addendum
would be the cost of developing the
form and the cost of filling out the form.
There is no associated burden for
hospices to communicate/coordinate
with non-hospice providers regarding
the content of the addendum statement
because the hospice CoPs, as described
above, have always required hospices to
have a system of communication with
non-hospice providers in place.
However, we believe that the election
statement addendum would reduce
burden for non-hospice providers
through a consistent and streamlined
process by which non-hospice providers
can make informed treatment decisions
and accurately submit claims with the
appropriate condition code or modifier.
1. Estimated Hospice Burden With
Election Statement Addendum
a. Estimated One-Time Form
Development
We estimate a one-time burden for the
development of a template election
statement addendum. We estimate that
it would take a hospice administrative
assistant 15 minutes (15/60 = 0.25
hours) to develop the addendum with
the required elements, and the hospice
administrator 15 minutes (15/60 = 0.25
hours) to review the addendum. The
clerical time plus administrator time
equals a one-time burden of 30 minutes
or (30/60 = 0.50 hours) per hospice. For
all 4,465 hospices, the total time
required would be (0.50 × 4,465) =
2,232.5 hours. At $59.18 per hour for an
executive administrative assistant, the
cost per hospice would be (0.25 ×
$59.18) = $14.80. At $119.12 per hour
for the administrator’s time, the cost per
hospice would be (0.25 × $119.12) =
$29.78. Therefore, the one-time cost, per
hospice, for the development of the
template would be ($14.80 + 29.78) =
$44.58, and the total one-time cost for
all hospices would be ($44.58 × 4,465)
= $199,050.
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b. Estimated Time for Hospice To
Complete Addendum
Per the hospice CoPs at § 418.56(a),
the hospice must designate a registered
nurse that is a member of the
interdisciplinary group to provide
coordination of care and to ensure
continuous assessment of each patient’s
and family’s needs and implementation
of the interdisciplinary plan of care. The
hospice CoPs at § 418.54 require that a
registered nurse conduct the initial
assessment, therefore, the registered
nurse would be responsible for
completing the addendum for each
hospice election as part of the routine
admission paperwork. We estimate that
there would be 1,268,497 hospice
elections in a year based on FY 2017
claims data. Approximately 28 percent
of hospice beneficiaries die within the
first 5 days after the hospice election
date. Hospices would not be required to
complete the election statement
addendum for those hospice
beneficiaries that die within 5 days of
hospice election. Therefore, the
estimated total number of hospice
elections in FY 2020 that would require
the hospice election statement
addendum would be (1,268,497 × 0.72)
= 913,318. There are 4,465 Medicarecertified hospices, so on average there
would be (913,318/4,465) = 205 hospice
elections per hospice. The estimated
burden for the hospice registered nurse
to extrapolate this information from the
existing documentation in the patient’s
hospice medical record and complete
this addendum would be 10 minutes
(10/60 = 0.1667). At $72.60 per hour for
a registered nurse over 10 minutes
(0.1667 × $72.60 = $12.10), we estimate
the total cost of RN time to complete the
addendum per hospice in FY 2020 to be
($12.10 × 205) = $2,481, and the total
cost of RN time to complete the
addendum for all hospices in FY 2020
would be ($2,481 × 4,465) =
$11,077,665. The estimated total per
hospice and total annual hospice cost
associated with the proposed addendum
(including one-time form development
and total RN costs) in FY 2020 are
shown in Table 20 below. These total
costs would include the one-time
development of the addendum, so
subsequent years’ costs would only
include the cost for the RN to complete
the addendum statement. Providing this
information to the beneficiary would be
part of the routine admissions process
and, as such, incurs no additional
burden to that process.
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To ensure comprehensive and
coordinated care, the CoPs at § 418.56(e)
require hospices to have a
communication system that allows for
the exchange of information with other
non-hospice health care providers who
are furnishing care unrelated to the
terminal illness and related conditions.
Therefore, it is our expectation that
hospices are already determining what
is related and unrelated to the terminal
illness and related conditions. The
election statement addendum would
add no additional burden for
communicating with non-hospice
providers, as this decision-making
process has been a long-standing CoP
requirement, as described above and in
the preamble of this final rule. However,
burden would be reduced for nonhospice providers, including
institutional, non-institutional and
pharmacy providers because less time
would be spent trying to obtain needed
information for treatment decisions and
accurate claims submissions.
For the calculation of this burden
estimate, we did drop those elections
where the beneficiary died within the
first 5 days. To estimate the cost burden
reduction, we first calculated the
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estimated current burden, in the
absence of the addendum, for
communicating and coordinating
information regarding unrelated
conditions between hospice and nonhospice providers. Next, we calculated
the estimated burden, using the
addendum for communicating and
coordinating information regarding
unrelated conditions between hospice
and non-hospice providers. Finally, we
analyzed the difference between the
burden estimates to see if there is any
overall reduction. To do this, we
analyzed all Medicare Parts A and B
non-hospice claims for beneficiaries
under a hospice election in FY 2017. We
also examined the Part D claims for
drugs provided to hospice beneficiaries
under a hospice election. Specifically,
we analyzed the following:
• The total number of non-hospice,
institutional claims with condition code
07 (to indicate the services were
unrelated to the terminal illness and
related conditions).
• The total number of non-hospice,
non-institutional claims with ‘‘GW’’
modifier (to indicate the services were
unrelated to the terminal illness and
related conditions).
• The total number of Part D claims
for beneficiaries under a hospice
election.
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• The average number of hospice
beneficiaries per non-hospice provider
with institutional claims with condition
code 07.
• The average number of hospice
beneficiaries per non-hospice provider
with non-institutional claims with
‘‘GW’’ modifier.
• The average number of hospice
beneficiaries per non-hospice provider
with Part D claims.
To calculate the average number of
hospice beneficiaries per non-hospice
provider, we count the number of
unique beneficiaries associated with
each non-hospice provider as
beneficiaries may receive services by
more than one non-hospice provider.
This means that some beneficiaries are
double-counted. However, given this
estimate is calculated based on the
number of expected communication
encounters between hospices and nonhospice providers, this is the
appropriate approach. Because we
double-counted beneficiaries, we expect
that average to be larger than the ratio
of unique beneficiaries to unique nonhospice providers. Table 21 below
summarizes Part A, B and D claims that
overlap with hospice episodes in FY
2017.
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3. Burden Estimate Without Election
Statement Addendum for Non-Hospice
Providers
In order for non-hospice providers to
make treatment decisions regarding
services, items, and drugs for hospice
beneficiaries and to submit the
appropriate modifier or condition code
on Medicare claims, they need
supporting information from the
hospice regarding related and unrelated
conditions. As such, we first estimate
the current burden associated with this
communication and coordination in the
absence of the election statement
addendum. We believe this would
require the non-hospice providers to
contact the hospice and have a detailed
phone call to obtain and document the
information on unrelated conditions,
items, services, and medications. For
non-hospice providers submitting
institutional claims (including inpatient
acute care hospitals, SNFs, HHAs, and
institutional outpatient providers),
typically nurse case managers provide
coordination of care for those
beneficiaries in these settings who are
receiving inpatient services or who are
preparing to transition to a post-acute
care setting or home. The estimated
burden for the registered nurse to
contact the hospice to obtain the needed
information would be 15 minutes (15/60
= 0.25). The average number of hospice
beneficiaries receiving services per
institutional, non-hospice provider is 11
per year, which would mean each
institutional, non-hospice provider
would have an average of 11
communication encounters with
hospice. The total number of
institutional, non-hospice providers
servicing hospice beneficiaries in FY
2017 was 19,226. At $72.60 per hour for
a registered nurse (0.25 × $72.60) =
$18.15, we estimate the total cost per
institutional, non-hospice provider
furnishing services to hospice
beneficiaries in FY 2020 to be ($18.15 ×
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11) = $199.65 and the annual total cost
for all institutional, non-hospice
providers in FY 2018 would be ($199.65
× 19,226) = $3,838,471.
For non-institutional, non-hospice
providers (including physicians), we
also expect that a nurse would contact
the hospice to obtain the needed clinical
information on unrelated conditions,
items, services and drugs. The estimated
burden for the registered nurse to
contact the hospice to obtain the needed
information would be 15 minutes (15/60
= 0.25). The average number of hospice
beneficiaries receiving services per noninstitutional, non-hospice provider is 11
per year, which would mean each
provider would have an average of 11
communication encounters with a
hospice. The total number of noninstitutional, non-hospice providers
servicing hospice beneficiaries in FY
2017 was 74,933. At $72.60 per hour for
a registered nurse (0.25 × $72.60) =
$18.15, we estimate the total cost per
non-institutional, non-hospice provider
furnishing services to hospice
beneficiaries in FY 2020 to be ($18.15 ×
11) = $199.65 and the annual total cost
for all non-institutional, non-hospice
providers in FY 2018 would be ($199.65
× 74,933) = $14,960,373.
For pharmacies dispensing Part D
drugs to hospice beneficiaries, the
estimated burden for the pharmacy
technician at the point of service to
contact the hospice to obtain the needed
clinical information regarding the drugs
deemed by the hospice as unrelated to
the terminal illness and related
conditions would be 15 minutes (15/60
= 0.25). The average number of hospice
beneficiaries receiving services per
pharmacy dispensing Part D
maintenance drugs is 12 per year, which
would mean each pharmacy would have
an average of 12 communication
encounters with hospice. The total
number of pharmacies dispensing Part D
maintenance drugs to hospice
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beneficiaries in FY 2017 was 60,632. At
$32.70 per hour for a pharmacy
technician (0.25 × $32.70) = $8.18, we
estimate the total cost per pharmacy
dispensing Part D maintenance drugs to
be ($8.18 × 12) = $98.16 and the annual
total cost for all pharmacies dispensing
Part D maintenance drugs to be ($98.16
× 60,632) = $5,951,637. The estimated
total annual burden for all non-hospice
providers furnishing services, items and
medications to hospice beneficiaries in
FY 2020 without the availability of the
hospice election statement addendum
identifying unrelated conditions, items,
services and drugs would be
$24,750,481 ($3,838,471 + $14,960,373
+ $5,951,637).
4. Burden Reduction Estimate With
Election Statement Addendum for NonHospice Providers
However, with the availability of the
‘‘Patient Notification of Hospice
Covered/Non-Covered Items, Services,
and Drugs’’ election statement
addendum, we believe this estimated
burden would be reduced for nonhospice providers through a
streamlining of the communication and
coordination process. For institutional,
non-hospice providers (those who
would submit claims for unrelated
services with condition code 07), the
estimated burden for the registered
nurse to contact the hospice to obtain
the needed information would be
reduced from 15 minutes in the absence
of the addendum to 5 minutes (5/60 =
0.0833). The average number of hospice
beneficiaries receiving services per
institutional non-hospice provider is 11
per year. The total number of
institutional non-hospice providers
servicing hospice beneficiaries in FY
2017 was 19,226. At $72.60 per hour for
a registered nurse (0.0833 × $72.60) =
$6.05, we estimate the total cost per
institutional non-hospice provider in FY
2020 to be ($6.05 × 11) = $66.55 and the
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annual total cost for all institutional
non-hospice providers in FY 2020
would be ($66.55 × 19,226) = $1,279,490
an annual decrease in burden by
($3,838,471 ¥ 1,279,490) = $2,558,981.
For non-institutional, non-hospice
providers (those who would submit
claims for unrelated services with
modifier GW), the estimated burden for
the registered nurse to contact the
hospice to obtain the needed
information would be reduced to 5
minutes (5/60 = 0.0833). The average
number of hospice beneficiaries
receiving services per non-institutional,
non-hospice provider is 11 per year. The
total number of non-institutional, nonhospice providers servicing hospice
beneficiaries in FY 2017 was 74,933. At
$72.60 per hour for a registered nurse
(0.0833 × $72.60) = $6.05, we estimate
the total cost per non-institutional, nonhospice provider in FY 2020 to be
($6.05 × 11) = $66.55 and the annual
total cost for all non-institutional, nonhospice providers in FY 2020 would be
($66.55 × 74,933) = $4,986,791, an
annual decrease in burden by
($14,960,373 ¥ 4,986,791) = $9,973,582.
For pharmacies dispensing Part D
drugs to hospice beneficiaries, the
estimated burden for the pharmacy
technician at the point of service to
contact the hospice to obtain the needed
clinical information regarding the drugs
deemed by the hospice as unrelated to
the terminal illness and related
conditions would be reduce to 5
minutes (5/60 = 0.0833). The average
number of hospice beneficiaries
receiving services from pharmacies
dispensing Part D maintenance drugs is
12 per year. The total number of
pharmacies dispensing Part D
maintenance drugs to hospice
beneficiaries in FY 2017 was 60,632. At
$32.70 per hour for a pharmacy
technicians (0.0833 × $32.70) = $2.72,
we estimate the total cost per
pharmacies dispensing Part D
maintenance drugs to be ($2.72 × 12) =
$32.64 and the annual total cost for all
pharmacies dispensing Part D
maintenance drugs to be ($32.64 ×
60,632) = $1,979,028, an annual
decrease in burden by ($5,951,637 ¥
$1,979,028) = $3,972,609. The estimated
total annual burden for all non-hospice
providers furnishing services, items and
drugs to hospice beneficiaries in FY
2020 with the availability of the hospice
election statement addendum
identifying unrelated conditions, items,
services and medication would be
$8,245,309 ($1,279,490 + $4,986,791 +
$1,979,028) for an overall burden
reduction of ($24,750,481 ¥ $8,245,309)
= $16,505,172. The total reduction in
burden for all institutional, noninstitutional, and Part D pharmacy nonhospice providers is summarized in
Table 22 below.
The use of the ‘‘Patient Notification of
Hospice Non-Covered Items, Services,
and Drugs’’ election statement
addendum would result in an estimated,
annual net reduction in burden of
$5,228,457 ($11,276,715¥$16,505,172)
in FY 2020. Table 23 below summarizes
the FY 2020 estimated total burden
reduction.
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B. Comments
We note that many commenters stated
that CMS underestimated the amount of
time it would take for the nurse to
complete the addendum stating that 10
minutes is an insufficient amount of
time to extrapolate this information
from the existing documentation. A few
commenters stated that this would take
between 20 and 30 minutes to complete.
Others stated that this is not just a
process of extrapolating the information,
but that this is often a process of
information gathering as not all relevant
information is readily available at the
time of the initial assessment. However,
a few commenters believed that even
though the timeframe to complete the
addendum would be longer than 10
minutes, they suggested that the
addendum should not be optional but
patients (or their representatives) should
be provided this detailed list as this is
critical to the care process, patient
empowerment, quality of care, and
transparency. However, we remind
hospices that the addendum is only
required if the beneficiary (or
representative) requests this
information, though for purposes of this
burden reduction estimate we calculate
it as it every eligible beneficiary
requests the addendum. Additionally,
there are those hospices that will cover
all items, services, and drugs, and
therefore, this would further reduce the
number of hospice elections in which
the addendum would be provided.
Furthermore, if a beneficiary requests
the addendum at the time of hospice
election but dies within 5 days, the
hospice would not be required to
furnish the addendum and the
requirement would be deemed as having
being met in this circumstance.
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C. Submission of PRA-Related
Comments
We have submitted a copy of this final
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.
To obtain copies of the supporting
statement and any related forms for the
proposed collections previously
discussed, visit our website at: https://
www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html,
or call the Reports Clearance Office at
(410) 786–1326.
VI. Regulatory Impact Analysis
A. Statement of Need
This final rule meets the requirements
of our regulations at § 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 Core-Based Statistical Areas (CBSAs)
or previously used Metropolitan
Statistical Areas (MSAs), as well as any
changes to the methodology for
determining the per diem payment
rates. This final rule also updates
payment rates for each of the categories
of hospice care, described in
§ 418.302(b), for FY 2020 as required
under section 1814(i)(1)(C)(ii)(VII) of the
Act. The payment rate updates are
subject to changes in economy-wide
productivity as specified in section
1886(b)(3)(B)(xi)(II) of the Act. Lastly,
section 3004 of the Affordable Care Act
amended the Act to authorize a quality
reporting program for hospices, and this
rule discusses changes in the
requirements for the hospice quality
reporting program in accordance with
section 1814(i)(5) of the Act.
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B. Overall Impacts
We estimate that the aggregate impact
of the payment provisions in this final
rule would result in an estimated
increase of $520 million in payments to
hospices, resulting from the hospice
payment update percentage of 2.6
percent for FY 2020. Section
1814(i)(6)(D)(ii) of the Act requires the
final rebasing of the per diem payment
rates for CHC, GIP, and IRC to be done
in a budget-neutral manner in the first
year of implementation. Therefore, the
final rebased rates for CHC, GIP, and
IRC would not result in an overall
payment impact for the Medicare
program as we are finalizing the
reduction of the RHC payment rates to
ensure that total estimated payments to
hospices are budget-neutral given the
increases to the CHC, GIP, and IRC
payment rates. In addition, the final
change in the hospice wage index to use
the FY 2020 pre-floor, pre-reclassified
hospital wage index (rather than the FY
2019 pre-floor, pre-reclassified hospital
wage index) as the basis for the FY 2020
hospice wage index would not result in
an overall payment impact for the
Medicare program as annual wage index
updates are now similarly implemented
in a budget-neutral manner. 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
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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), the Congressional
Review Act (5 U.S.C. 804(2)), and
Executive Order 13771 on Reducing
Regulation and Controlling Regulatory
Costs (January 30, 2017).
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
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 Regulatory Flexibility Act (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
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(SBA) definition of a small business (in
the service sector, having revenues of
less than $7.5 million to $38.5 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.
HHS’s 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 2020
hospice payment update percentage
results in an overall increase in
estimated hospice payments of 2.6
percent, or $520 million. The
distributional effects of the final FY
2020 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.
Finally, the distributional effects of the
final FY 2020 increases to the CHC, IRC,
and GIP per diem payment rates as a
result of rebasing, offset by a decrease to
the FY 2020 RHC payment rates of less
than 3 percent to maintain budget
neutrality in the first year of
implementation, 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
Social Security Act requires us to
prepare a regulatory impact analysis if
a rule may have a significant impact on
the operations of a substantial number
of small rural hospitals. This analysis
must conform to the provisions of
section 604 of the RFA. For purposes of
section 1102(b) of the Act, we define a
small rural hospital as a hospital that is
located outside of a metropolitan
statistical area 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.
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 2019 UMRA
threshold is $154 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
$154 million or more.
Executive Order 13132 establishes
certain requirements that an agency
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38539
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
final 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 the published proposed
rule will be the number of reviewers of
this final rule. We acknowledge that this
assumption may understate or overstate
the costs of reviewing this final rule. It
is possible that not all commenters
reviewed the proposed rule in detail,
and it is also possible that some
reviewers chose not to comment on the
proposed rule. For these reasons we
thought that the number of past
commenters would be a fair estimate of
the number of reviewers of this final
rule.
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 $107.38 per
hour, including overhead and fringe
benefits (https://www.bls.gov/oes/
current/oes_nat.htm). This final rule
consists of approximately 57,000 words
in its entirety. Assuming an average
reading speed of 250 words per minute,
it would take approximately 2 hours for
the staff to review half of it. For each
hospice that reviews the rule, the
estimated cost is approximately $215.00
(2 hours × $107.38). Therefore, we
estimate that the total cost of reviewing
this regulation is $32,250 ($215.00 × 150
reviewers).
D. Detailed Economic Analysis
1. Hospice Payment Update for FY 2020
The FY 2020 hospice payment
impacts appear in Table 24. 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
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second column shows the number of
hospices in each of the categories in the
first column. The third column shows
the effects of applying the final rebased
payment rates of CHC, IRC, and GIP
(and the decreased RHC rate used to
achieve budget neutrality). The fourth
column shows the hospice payments
using FY 2018 Hospice Claims, FY 2020
rebased Payments, and FY 2020 Wage
Index without the 1-Year lag. The fifth
column show the final FY 2020 hospice
payment update percentage of 2.6
percent as mandated by section
1814(i)(1)(C) of the Act, and is
consistent for all providers. The 2.6
percent hospice payment update
percentage is based on an estimated 3.0
percent inpatient hospital market basket
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update, reduced by a 0.4 percentage
point productivity adjustment. It is
projected that aggregate payments
would increase by 2.6 percent, assuming
hospices do not change their service and
billing practices. The sixth column
shows the total impact for FY 2020. We
have set the rates so the overall impact
is zero percent due to the requirement
that any revisions in payment are
implemented in a budget-neutral
manner in accordance with section
1814(i)(6)(D)(ii) of the Act
(accomplished by rebasing the CHC,
GIP, and IRC payment rates by a
corresponding decrease to the RHC
payment rates).
In addition, to assist providers in
understanding the impacts of the final
wage index without the lag and the
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rebasing of CHC, IRC, and GIP, we are
providing a provider-specific impact
analysis file, which is available on our
website at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/Hospice/Hospice-Regulationsand-Notices.html. We note that
simulated payments are based on
utilization in FY 2018 as seen on
Medicare hospice claims (accessed from
the CCW in May 2019) 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 24, the
combined effects of all the proposals
vary by specific types of providers and
by location.
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All Hospices
FY2020
Hospice
Payment
Update
Percentage
Total
Impact for
FY2020
4,599
0.0%
0.0%
2.6%
2.6%
2,843
-0.8%
0.0%
2.6%
1.8%
-0.3%
2.6%
2.3%
39
0.0%
Freestanding/Other
325
0.2%
0.1%
2.6%
2.9%
Provider/HHA-Based/Non-Profit
396
0.7%
-0.1%
2.6%
3.2%
Provider/HHA-Based/For-Profit
196
-1.3%
-0.1%
2.6%
1.2%
Provider/HHA-Based/Government
101
0.4%
-0.1%
2.6%
2.9%
Provider/HHA-Based/Other
97
0.6%
0.1%
2.6%
3.3%
3,809
0.0%
0.0%
2.6%
2.6%
790
0.2%
-0.1%
2.6%
2.7%
Subtotal: Non-Profit
998
1.2%
0.0%
2.6%
3.8%
Subtotal: For Profit
3,039
-0.8%
0.0%
2.6%
1.8%
Subtotal: Government
140
0.2%
-0.2%
2.6%
2.6%
Subtotal: Other
422
0.3%
0.1%
2.6%
3.0%
Freestanding/Government
20
-0.9%
-0.3%
2.6%
1.4%
Freestanding/Other
45
-1.3%
0.0%
2.6%
1.3%
Provider/HHA-Based/Non-Profit
157
0.6%
-0.2%
2.6%
3.0%
Provider/HHA-Based/For-Profit
47
-1.6%
-0.2%
2.6%
0.8%
Provider/HHA-Based/Government
74
-0.7%
0.0%
2.6%
1.9%
Provider/HHA-Based/Other
54
-0.5%
0.3%
2.6%
2.4%
2,514
-0.7%
0.0%
2.6%
1.9%
19
0.2%
-0.3%
2.6%
2.5%
Subtotal:
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Hospices
Rebasing
ofCHC,
IRC, and
GIP
FY2020
Updated
Wage
Data
Without
the 1
Year Lag
280
0.3%
0.1%
2.6%
3.0%
Provider/HHA-Based/Non-Profit
239
0.7%
0.0%
2.6%
3.3%
Provider/HHA-Based/For-Profit
149
-1.3%
-0.1%
2.6%
1.2%
Provider/HHA-Based/Government
27
1.4%
-0.2%
2.6%
3.8%
Provider/HHA-Based/Other
43
0.9%
0.0%
2.6%
3.5%
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2. Hospice Election Statement
Addendum
This final rule includes requirements
related to the election statement
addendum that must be provided, upon
request, to hospice beneficiaries (or
representative), non-hospice providers,
and Medicare contractors. This change
is effective for hospice elections on and
after October 1, 2020. The burden
estimate for hospices to develop and
complete the election statement
addendum is provided in section V of
this final rule. However, the election
statement addendum adds no additional
burden for communicating with nonhospice providers, as this decisionmaking process has been a longstanding CoP requirement, as described
in the preamble of this rule.
Furthermore, burden would be reduced
for non-hospice providers, including
institutional, non-institutional and
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pharmacy providers because less time
would be spent trying to obtain needed
information for treatment decisions and
accurate claims submissions. As a result
of this election statement addendum, we
estimate that this rule generates $5.2
million in an annualized net reduction
in burden, or $3.7 million per year on
an ongoing basis discounted at 7 percent
relative to year 2016, over a perpetual
time horizon beginning in FY 2021. The
burden reduction estimate for the
addendum is detailed in section V of
this final rule and the total annual
reduction is included in Table 25.
E. 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 25, we have prepared
an accounting statement showing the
classification of the transfers and costs
associated with the provisions of this
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final rule. This table shows an estimated
$520 million in transfers to hospices in
FY 2020. All expenditures are classified
as transfers to hospices. Table 25 also
reflects the estimated change in costs
and burden for hospices and nonhospice providers as a result of the
finalized election statement addendum
requirements described in section III.C.
Table 20 provides our best estimate of
a one-time burden for hospices to
develop the election statement
addendum form of approximately 2,233
hours or $199,050, as well as our
estimate of the annual burden for
hospices to complete the election
statement addendum of approximately
746 hours or $11 million for an
estimated total burden for hospices of
$11.2 million, as described in section IV
of this final rule. Additionally, we
estimate a net reduction in burden for
non-hospice providers of approximately
25,900 hours or $16.5 million (see
section IV of this final rule) for an
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38542
estimated overall, annualized net
reduction in burden with the proposed
election statement addendum of $5.2
million.
F. Regulatory Reform Analysis Under
E.O. 13771
G. Conclusion
Executive Order 13771, entitled
‘‘Reducing Regulation and Controlling
Regulatory Costs,’’ was issued on
January 30, 2017 (82 FR 9339, February
3, 2017) and requires that the costs
associated with significant new
regulations ‘‘shall, to the extent
permitted by law, be offset by the
elimination of existing costs associated
with at least two prior regulations.’’
This final rule is expected to be an E.O.
13771 deregulatory action with $5.2
million in an annualized net reduction
in burden, or $3.7 million per year on
an ongoing basis discounted at 7 percent
relative to year 2016, over a perpetual
time horizon beginning in FY 2021. The
burden reduction for the addendum is
detailed in section V of this final rule
and the total annual net reduction in
burden is included in Table 25. Details
on the estimated net reduction in
burden of this rule can be found in the
rule’s collection of information and
economic analysis.
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We estimate that aggregate payments
to hospices in FY 2020 will increase by
$520 million, or 2.6 percent, compared
to payments in FY 2019. We estimate
that in FY 2020, hospices in urban and
rural areas will experience, on average,
2.7 percent and 1.8 percent increases,
respectively, in estimated payments
compared to FY 2019. Hospices
providing services in the South Atlantic,
Middle Atlantic, and East North Central
regions would experience the largest
estimated increases in payments of 4.5
percent, 2.6 percent, and 2.6 percent,
respectively. Hospices serving patients
in the West North Central and outlying
regions would experience, on average,
the lowest estimated increase of 1.4
percent and -0.3 percent, respectively in
FY 2020 payments. We are finalizing the
modifications to the election statement
including the election statement
addendum in this final rule with an
implementation date of October 1, 2020
to allow hospices additional time to
make the necessary changes to meet
these requirements. We also estimate an
overall net reduction in burden of $5.2
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38543
million beginning in FY 2021 as a result
of the finalized election statement
addendum. 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 amends 42 CFR
chapter IV as set forth below.
PART 418—HOSPICE CARE
1. The authority citation for part 418
is revised to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh.
2. Section 418.3 is amended by adding
the definition of ‘‘BFCC–QIO’’ to read as
follows:
■
§ 418.3
*
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*
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BFCC–QIO means Beneficiary and
Family Centered Care Quality
Improvement Organization.
*
*
*
*
*
■ 3. Section 418.24 is amended by —
■ a. Revising paragraphs (b)(2) and (3);
■ b. Redesignating paragraph (b)(5) as
paragraph (b)(8);
■ c. Adding new paragraphs (b)(5), (6),
and (7);
■ d. Redesignating paragraphs (c)
through (f) as paragraphs (d) through (g)
respectively; and
■ e. Adding a new paragraph (c).
The revisions and additions read as
follows:
§ 418.24
Election of hospice care.
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*
*
*
*
*
(b) * * *
(2) The individual’s or
representative’s acknowledgement that
he or she has been given a full
understanding of the palliative rather
than curative nature of hospice care, as
it relates to the individual’s terminal
illness and related conditions.
(3) Acknowledgement that the
individual has been provided
information on the hospice’s coverage
responsibility and that certain Medicare
services, as set forth in paragraph (e) of
this section, are waived by the election.
For Hospice elections beginning on or
after October 1, 2020, this would
include providing the individual with
information indicating that services
unrelated to the terminal illness and
related conditions are exceptional and
unusual and hospice should be
providing virtually all care needed by
the individual who has elected hospice.
*
*
*
*
*
(5) For Hospice elections beginning
on or after October 1, 2020, the Hospice
must provide information on individual
cost-sharing for hospice services.
(6) For Hospice elections beginning
on or after October 1, 2020, the Hospice
must provide notification of the
individual’s (or representative’s) right to
receive an election statement
addendum, as set forth in paragraph (c)
of this section, if there are conditions,
items, services, and drugs the hospice
has determined to be unrelated to the
individual’s terminal illness and related
conditions and would not be covered by
the hospice.
(7) For Hospice elections beginning
on or after October 1, 2020, the Hospice
must provide information on the
Beneficiary and Family Centered Care
Quality Improvement Organization
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(BFCC–QIO), including the right to
immediate advocacy and BFCC–QIO
contact information.
*
*
*
*
*
(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. If the election
statement addendum is requested at the
time of 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. If this addendum is
requested during the course of hospice
care (that is, after the hospice election
date), the hospice must provide this
information, in writing, within 72 hours
of the request to the requesting
individual (or representative), nonhospice provider, or Medicare
contractor. If there are any changes to
the content on the addendum during the
course of hospice care, the hospice must
update the addendum and provide these
updates, in writing, to the individual (or
representative). The election statement
addendum must include the following:
(1) The addendum must be titled
‘‘Patient Notification of Hospice NonCovered Items, Services, and Drugs.’’
(2) Name of the hospice.
(3) Individual’s name and hospice
medical record identifier.
(4) Identification of the individual’s
terminal illness and related conditions.
(5) A list of the individual’s
conditions present on hospice
admission (or upon plan of care update)
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 individual (or
representative) can understand, as to
why the identified conditions, items,
services, and drugs are considered
unrelated to the individual’s terminal
illness and related conditions and not
needed for pain or symptom
management. This clinical explanation
must be accompanied by a general
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statement that the decision as to
whether or not conditions, items,
services, and drugs are related is made
for each patient and that the individual
should share this clinical explanation
with other health care providers from
which they seek items, services, or
drugs unrelated to their terminal illness
and related conditions.
(7) References to any relevant clinical
practice, policy, or coverage guidelines.
(8) Information on the following:
(i) Purpose of Addendum. The
purpose of the addendum is to notify
the individual (or representative), in
writing, of those conditions, items,
services, and drugs the hospice will not
be covering because the hospice has
determined they are unrelated to the
individual’s terminal illness and related
conditions.
(ii) Right to Immediate Advocacy. The
addendum must include language that
immediate advocacy is available
through the Medicare Beneficiary and
Family Centered Care-Quality
Improvement Organization (BFCC–QIO)
if the individual (or representative)
disagrees with the hospice’s
determination.
(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
necessarily the individual’s (or
representative’s) agreement with the
hospice’s determinations.
*
*
*
*
*
§ 418.26
[Amended]
4. Section 418.26 is amended in
paragraph (c)(2) by removing the
reference ‘‘§ 418.24(d)’’ and adding in
its place the reference ‘‘§ 418.24(e)’’.
■
§ 418.28
[Amended]
5. Section 418.28 is amended in
paragraph (c)(2) by removing the
reference ‘‘§ 418.24(e)(2)’’ and adding in
its place the reference ‘‘§ 418.24(f)(2)’’.
■
Dated: July 25, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: July 26, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2019–16583 Filed 7–31–19; 4:15 pm]
BILLING CODE 4120–01–P
E:\FR\FM\06AUR3.SGM
06AUR3
]]>Agencies
[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Rules and Regulations]
[Pages 38484-38544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16583]
[[Page 38483]]
Vol. 84
Tuesday,
No. 151
August 6, 2019
Part IV
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 418
Medicare Program; FY 2020 Hospice Wage Index and Payment Rate Update
and Hospice Quality Reporting Requirements; Final Rule
Federal Register / Vol. 84 , No. 151 / Tuesday, August 6, 2019 /
Rules and Regulations
[[Page 38484]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 418
[CMS-1714-F]
RIN 0938-AT71
Medicare Program; FY 2020 Hospice Wage Index and Payment Rate
Update and Hospice Quality Reporting Requirements
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule updates the hospice wage index, payment rates,
and cap amount for fiscal year 2020. This rule also rebases the
continuous home care, general inpatient care, and the inpatient respite
care per diem payment rates in a budget-neutral manner to more
accurately align Medicare payments with the costs of providing care. In
addition, this rule modifies the election statement by requiring an
addendum that includes information aimed at increasing coverage
transparency for patient under a hospice election. Finally, this rule
includes changes to the Hospice Quality Reporting Program.
DATES: These regulations are effective on October 1, 2019.
FOR FURTHER INFORMATION CONTACT: For general questions about hospice
payment policy, send your inquiry via email to:
[email protected].
Debra Dean-Whittaker, (410) 786-0848 for questions regarding the
CAHPS[supreg] Hospice Survey.
Cindy Massuda, (410) 786-0652 for questions regarding the hospice
quality reporting program.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose
This final rule makes updates to the hospice wage index, payment
rates, and cap amount for fiscal year (FY) 2020, as required under
section 1814(i) of the Social Security Act (the Act). This rule also
rebases the continuous home care (CHC), general inpatient care (GIP),
and inpatient respite care (IRC) per diem payment rates in a budget
neutral manner to more accurately align payments with the costs of
providing care, using the hospice payment reform authority under
section 1814(i)(6) of the Act. This rule changes the hospice wage index
to remove the 1-year lag in data by using the current year's hospital
wage data to establish the hospice wage index. In addition, this rule
modifies the hospice election statement by requiring an addendum that
includes information aimed at increasing coverage transparency for
patients under a hospice election. Finally, this rule includes changes
to the Hospice Quality Reporting Program.
B. Summary of the Major Provisions
Section III.A.2 of this final rule describes the FY 2020 hospice
per diem payment rebasing methodology, cost reports and calculations.
Using the hospice payment reform authority under section 1814(i)(6) of
the Act, section III.A.3 of this final rule rebases the FY 2020 per
diem payment rates for CHC, IRC, and GIP levels of care. As required in
section 1814(i)(6)(D)(ii) of the Act, any changes to hospice payment
rates must be done in a budget neutral manner. As such, section III.A.3
also finalizes a reduction to the routine home care (RHC) payment
amounts for FY 2020 in order to maintain overall budget neutrality.
Section III.B.1 of this rule eliminates the 1-year lag of the pre-
floor, pre-reclassified hospital wage index that is used in calculating
the hospice wage index. Section III.B.2 updates 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.B.3 of this rule, we
discuss the FY 2020 hospice payment update percentage of 2.6 percent.
Section III.B.4 outlines the final FY 2020 hospice payment rates.
Section III.B.5 of this final rule updates the hospice cap amount for
FY 2020 by the hospice payment update percentage discussed in section
III.B.3 of this rule. Section III.C modifies the hospice election
statement content requirements at Sec. 418.24(b) to increase coverage
transparency for patients under a hospice election by notifying
beneficiaries if there are services that will not be covered by the
hospice.
Finally, in section III.E of this rule, we discuss updates to the
Hospice Quality Reporting Program (HQRP), including: The development of
claims-based and outcome measures, measure concepts, and the hospice
assessment tool. We also provide updates on the public reporting change
for the ``Hospice Visits When Death is Imminent'' measure pair, the
posting of publicly available government data to the CMS Hospice
Compare website, and the CAHPS[supreg] Hospice Survey.
C. Summary of Impacts
The overall economic impact of this final rule is estimated to be
$520 million in increased payments to hospices for FY 2020.
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's prognosis is for a life expectancy of 6 months or less
if the terminal illness runs its normal course. The regulations at
Sec. 418.22(b)(3) require that the certification and recertification
forms include a brief narrative explanation of the clinical findings
that support a life expectancy of 6 months or less.
Under the Medicare hospice benefit, the election of hospice care is
a patient choice and once a terminally ill patient elects to receive
hospice care, a hospice interdisciplinary group is essential in the
seamless provision of services. These hospice services are provided
primarily in the individual's home. The hospice interdisciplinary group
works
[[Page 38485]]
with the beneficiary, family, and caregivers to develop a coordinated,
comprehensive care plan; reduce unnecessary diagnostics or ineffective
therapies; and maintain ongoing communication with individuals and
their families about changes in their condition. The beneficiary's care
plan will shift over time to meet the changing needs of the individual,
family, and caregiver(s) as the individual approaches the end of life.
If, in the judgment of the hospice interdisciplinary team, which
includes the hospice physician, the patient's symptoms cannot be
effectively managed at home, then the patient is eligible for general
inpatient care (GIP), a more medically intense level of care. GIP must
be provided in a Medicare-certified hospice freestanding facility,
skilled nursing facility, or hospital. GIP is provided to ensure that
any new or worsening symptoms are intensively addressed so that the
beneficiary can return to his or her home and continue to receive
routine home care. Limited, short-term, intermittent, inpatient respite
care (IRC) is also available because of the absence or need for relief
of the family or other caregivers. Additionally, an individual can
receive continuous home care (CHC) during a period of crisis in which
an individual requires continuous care to achieve palliation or
management of acute medical symptoms so that the individual can remain
at home. CHC may be covered for as much as 24 hours a day, and these
periods must be predominantly nursing care, in accordance with our
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: https://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 (now 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,
that 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 (described in 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 these
services are not reimbursed by Medicare (see 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 interdisciplinary group should
comprise 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 our 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 in one of four prospectively-
determined rate categories of hospice care (routine home care (RHC),
CHC, IRC, and GIP), based on each day a qualified Medicare beneficiary
is under hospice care (once the individual has elected). This per diem
payment is to include all of the hospice services and items needed to
manage the beneficiary's care, as required by section 1861(dd)(1) of
the Act. There has been little change in the hospice payment structure
since the benefit's inception. The per diem rate based on level of care
was established in 1983, and this payment structure remains today with
some adjustments, as noted below.
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.
3. FY 1998 Hospice Wage Index Final Rule
The FY 1998 Hospice Wage Index final rule (62 FR 42860),
implemented a new methodology for calculating the hospice wage index
and instituted an annual Budget Neutrality Adjustment Factor (BNAF) so
aggregate Medicare payments to hospices would remain budget neutral to
payments calculated using the 1983 wage index.
[[Page 38486]]
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 is
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. Beginning in FY 2014, hospices that fail to report
quality data have their market basket percentage increase reduced by 2
percentage points.
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, we 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, we were
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) we announced that beginning in 2012, the hospice aggregate cap
would be calculated using the patient-by-patient proportional
methodology, within certain limits. We allowed existing hospices 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. 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). Similar to 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 or 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, eligibility criteria, survey
respondents, and implementation of 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 failed
to timely submit their aggregate cap determinations had their payments
suspended until the determination is completed and received by the
Medicare contractor (79 FR 50503).
8. 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 update rather than using the consumer price index for
urban consumers (CPI-U) for medical care expenditures.
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
47172), we created two different payment rates for RHC that resulted in
a higher base payment rate for the first 60 days of hospice care and a
reduced base payment rate for subsequent days of hospice care. We also
created a Service Intensity Add-on (SIA) payment payable for services
during the last 7 days of the beneficiary's life, equal to the CHC
hourly payment rate multiplied by the amount of direct patient care
provided by a registered nurse (RN) or social worker that occurs during
the last 7 days (80 FR 47177).
In addition to the hospice payment reform changes discussed, the FY
2016 Hospice Wage Index and Rate Update final rule (80 FR 47186)
implemented changes mandated by the IMPACT Act, in which the cap amount
for accounting years that end after September 30, 2016
[[Page 38487]]
and before October 1, 2025 is updated by the hospice payment update
percentage rather than using the CPI-U. This was applied to the 2016
cap year, starting on November 1, 2015 and ending on October 31, 2016.
In addition, we finalized a provision to align the cap accounting year
for both the inpatient cap and the hospice aggregate cap with the
fiscal year for FY 2017 and thereafter. Finally, the FY 2016 Hospice
Wage Index and Rate Update final rule (80 FR 47144) clarified that
hospices must report all diagnoses of the beneficiary 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), we finalized several new policies and requirements related to
the HQRP. First, we codified our 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, we would continue
to utilize the measure in its new endorsed status, without going
through new notice-and-comment rulemaking. We would continue to use
rulemaking to adopt substantive updates made by the NQF to the endorsed
measures we have 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 HIS, and the measures were effective
April 1, 2017. Regarding the CAHPS[supreg] Hospice Survey, we 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 Consumer Assessment of Healthcare Providers and Systems
(CAHPS[supreg]) requirements due to newness (81 FR 52182). The
exemption is determined by CMS and is for 1 year only.
D. Trends in Medicare Hospice Utilization
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 513,000 in FY
2000 to over 1.5 million in FY 2018. Medicare hospice expenditures have
risen from $2.8 billion in FY 2000 to approximately $18.7 billion in FY
2018. CMS' Office of the Actuary (OACT) projects that hospice
expenditures are expected to continue to increase, by approximately 8.5
percent annually, reflecting an increase in the number of Medicare
beneficiaries, more beneficiary awareness of the Medicare hospice
benefit for end-of-life care, and a growing preference for care
provided in home and community-based settings.
As a part of our ongoing analysis of hospice utilization trends, we
examined the distribution of total hospice days by level of care. A
review of claims over the last 10 years shows that RHC remains the
highest utilized level of care, accounting for an average of 97.6
percent of total hospice days; GIP accounting for 1.7 percent of total
hospice days; CHC accounting for 0.4 percent of total hospice days;
and, IRC accounting for 0.3 percent of total hospice days.
There have also been notable changes in the diagnosis patterns
among Medicare hospice enrollees. At the time of the implementation of
the Medicare hospice benefit, cancer diagnoses were the most frequently
reported diagnoses. However, there has been a significant increase in
the reporting of neurologically-based diagnoses, including Alzheimer's
disease, which has been the top-reported diagnosis on hospice claims
since 2014. In the FY 2014 hospice final rule (78 FR 48242), we
clarified that ``Debility'' or ``adult failure to thrive'' should not
be used as a principal hospice diagnosis on the Hospice claim form per
ICD-9-CM Coding Guidelines. Since this clarification, there has been an
increase in the reporting of neurological conditions as the principal
diagnosis on hospice claims. Our ongoing analysis of diagnosis
reporting trends finds that neurological and organ-based failure
conditions remain top-reported principal diagnoses.
In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR
47201), we clarified that hospices are to report all diagnoses
identified in the initial and comprehensive assessments on hospice
claims, whether related or unrelated to the terminal prognosis of the
individual, effective October 1, 2015. Analysis of FY 2018 hospice
claims show that 100 percent of claims included at least one diagnosis,
90.3 percent of claims included at least two diagnoses, and 82.1
percent of claims included at least three diagnoses.
III. Provisions of the Final Rule
A. Rebasing of the Continuous Home Care, Inpatient Respite Care, and
General Inpatient Care Payment Rates for FY 2020
1. Background
Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of
the Act, and our regulations in 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 in 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 a hospice
election. These per diem payments include reimbursement for all of the
hospice services and items needed to manage the beneficiary's care, as
required by section 1861(dd)(1) of the Act. There has been little
change in the hospice payment structure since the benefit's inception.
The per diem rate based on level of care was established in 1983, and
this payment structure remains today.
We originally set the base payment rates for each level of care in
1983 using information from a relatively small set (n=26) of hospices
that were participating in a CMS hospice demonstration. As a result of
technological changes to providing hospice care that have occurred
since the early 1980's, as well as changes in the patient population
that uses the hospice benefit, it is possible that the current per diem
payment rates for the Medicare hospice benefit do not align accurately
with the costs of providing care. Since the establishment of the
hospice benefit, the base payment rates have been updated through the
years to primarily account for inflation, but we have not implemented
any large scale changes to reflect non-inflationary changes in costs
over time, with the exception of the bifurcation of the RHC payment
rate and the creation of the SIA payment finalized in the FY 2016
Hospice Wage Index and Payment Rate Update final rule implemented on
January 1, 2016 (80 FR 47142). For over a decade, MedPAC and other
organizations reported findings that suggested that the hospice
benefit's fixed per-diem payment system was inconsistent with the true
variance of service costs over the course of an episode.
[[Page 38488]]
In the FY 2020 proposed rule (84 FR 17577) we described the
information that was collected on hospice claims effective April 1,
2014 and additional changes in reporting requirements over the
following years.\2\ The revised cost report expands data collection
requirements to supply greater detail related to hospice costs by level
of care. Hospices are required to report all direct patient care costs
by multiple cost categories into the respective level of care. MedPAC,
the Government Accountability Office (GAO), and the Office of the
Inspector General (OIG) have all recommended that CMS collect more
comprehensive data to better evaluate trends in utilization of the
Medicare hospice benefit.
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\2\ CMS Transmittal 2864. Additional Data Reporting Requirements
for Hospice Claims. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2864CP.pdf.
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Effective for cost reporting periods beginning on or after October
1, 2014, freestanding hospices are required to file the revised hospice
cost report (Form CMS-1984-14). Provider-based hospices began using the
revised cost report form for cost reporting periods beginning on or
after October 1, 2015. The revised cost report expands data collection
requirements to supply greater detail related to hospice costs by level
of care. Hospices are required to report all direct patient care costs
by multiple cost categories into the respective level of care. Within
the revised cost report changes in 2014, there were modifications in
the manner in which general service costs and statistical information
is accumulated by the hospice and an expansion of the general service
cost centers. Instructions for completing the freestanding hospice cost
report (Form CMS-1984-14) are found in the Medicare Provider
Reimbursement Manual--Part 2, Chapter 43.\3\
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\3\ The Provider Reimbursement Manual--Part 2. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Paper-Based-Manuals-Items/CMS021935.html.
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In its March 2018 Report to the Congress, MedPAC stated Medicare's
payment rates for the CHC, IRC and GIP levels of care appear to be
lower than the average and median costs per day for freestanding
providers and suggested that rebalancing the payment rates may be
warranted.\4\ Additionally, we received public comments on past rules
that indicated the payment rates for CHC, IRC and GIP are much
different from the average costs of providing those levels of care.
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\4\ Medicare Payment Advisory Commission (MedPAC). ``Hospice
Services.'' Report to the Congress: Medicare Payment Policy.
Washington, DC. March 2018. P. 341. https://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch12_sec.pdf?sfvrsn=0.
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2. Methodology and Analysis of Costs per Day for Continuous Home Care,
Inpatient Respite Care, and General Inpatient Care
a. Hospice Cost Report Data
Using information collected from the revised hospice cost report,
for the first time, we are able to estimate hospices' average costs per
day by level of care. As required by section 1814(i)(1)(A) of the Act,
payment for hospice services must be an amount equal to the costs which
are reasonable and related to providing hospice care, or which are
based on such other tests of reasonableness as the Secretary may
prescribe in regulations. Therefore, given that we now have several
years' worth of cost report data from the revised hospice cost report,
we calculated the average costs per day by level of care and compared
such costs to the per diem payment rates by level of care to determine
if there is a misalignment between payment and costs and whether the
per diem payment rates for CHC, IRC, and GIP should be rebased. To
conduct this analysis, we used a variety of different data sources,
including cost reports and hospice claims data. In the FY 2020 proposed
rule, we provided a walkthrough of the methodology and analysis of
costs per day for continuous home care, inpatient respite care, and
general inpatient care (84 FR 17578). For this final rule, although we
used more recent cost report and claims data (still covering FY 2017),
the methodology to calculate such costs remains the same as in the FY
2020 proposed rule.
Our analysis was based on information obtained from the Healthcare
Cost Report Information System (HCRIS). The hospice cost report data
contains cost and statistical data for freestanding and provider-based
hospice providers. To determine the average per-day costs of providing
hospice services, we conducted initial analysis of both freestanding
and provider-based hospice cost reports.\5\
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\5\ Cost reports from FY 2017 had a start date on or after
October 1, 2016 and before October 1, 2017.
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As mentioned in the FY 2020 proposed rule (84 FR 17578), to create
the initial analytic file, we took a number of data cleaning steps to
exclude certain hospices such as excluding a small number of hospices
(as represented by CCN) that had multiple FY 2017 cost reports in the
HCRIS cost report data file (exclusion 1). For those hospices, we kept
the cost report that covered the greatest length of time in FY 2017.\6\
We eliminated SNF, HHA, and hospital cost reports that did not contain
a hospice CCN (exclusion 2); and we eliminated cost reports (as
represented by CCN) due to the same CCN listed multiple times (that is,
there might be two separate reports of RHC costs for the same CCN
within a provider-based cost report, or a CCN appeared in a
freestanding cost report as well as appeared in a provider based cost
report)(exclusion 3). In order to limit each hospice to one single cost
report, we selected the cost report with the highest RHC cost.\7\
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\6\ We determined the length of the cost report by subtracting
the cost reports fiscal year begin date from the cost reports fiscal
year end date.
\7\ For example, in one home health agency-based cost report,
the home health agency reported costs for the same hospice CCN three
different times on the same cost report.
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Next, we constructed a series of flags to identify hospice cost
reports that did not fill out fields that we would expect hospices to
report (for example, nursing services). We identified those cost report
fields using information from the Provider Reimbursement Manual--Part
2, Provider Cost Reporting Forms and Instructions, Chapter 43, Form
CMS-1984-14, Transmittal 3, dated April 13, 2018, that updated cost
reporting instructions for freestanding hospice cost reports.\8\ These
instructions describe a number of 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.
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\8\ Medicare Provider Reimbursement Manual--Part 2, Provider
Cost Reporting Forms and Instructions, Chapter 43, Form CMS-1984-14.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3P243.pdf.
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Finally, to remove outliers from this analysis, we applied another
set of exclusions as described in the FY 2019 Hospice Wage Index and
Payment Rate Update proposed rule (83 FR 20948). For each calculated
outcome (for example, average RHC costs per day), we excluded those
values that are above the 99th percentile and those values that are
below the 1st percentile. We refer to this trim as the ``1% Trim''.
After applying the trimming exclusions, including the Level I edits,
1,232 freestanding hospice cost reports remained as noted in Table 1
below:
[[Page 38489]]
Table 1--Number of FY 2017 Freestanding Hospice Cost Reports After the
Level I Edits Exclusion and 1% Trim
------------------------------------------------------------------------
Number of cost Number of days
Level of care reports after by level of
exclusions care (FY2017)
------------------------------------------------------------------------
RHC..................................... 1,109 43,255,420
GIP..................................... 817 790,195
CHC..................................... 440 187,554
IRC..................................... 915 135,384
------------------------------------------------------------------------
Note: We begin with the 3,223 freestanding cost reports that remained
after applying exclusions in 1-3. After applying the Level I edits,
1,232 freestanding cost reports remained. Not all cost reports contain
information on each level of care. Numbers noted above indicate the
number of cost reports available for analysis for each level of care
after all exclusions, including the 1% trim are applied.
b. Hospice Claims Data
We created an analytic data set based on Medicare hospice claims
downloaded from the Chronic Condition Data Warehouse--Virtual Research
Data Center (CCW VRDC) to examine hospice utilization on specific days
during FY 2017. We assigned a wage index (using the FY 2017 hospice
wage indices) to each day of hospice service based on the core-based
statistical area (CBSA) where a particular day's hospice services took
place.\9\ We merged information from the June 2018 release of the CMS
Provider of Services (POS) file to identify characteristics of each
hospice including: Ownership type, census division (based on the
hospice's state), and whether the hospice's main office was located
either in an urban or rural location. This data was used in the
subsequent section in calculating costs per day by level of care.
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\9\ FY 2017 Final Hospice Wage Index. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index/FY-2017-Final-Hospice-Wage-Index.html?DLPage=1&DLEntries=10&DLSort=0&;DLSortDir=descending.
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c. Calculating Costs per Day by Level of Care
In order to compute the average cost per day for each level of care
using information from the freestanding hospice cost reports, after
applying the exclusions, we made several adjustments to the average
cost calculations, as described in the FY 2020 proposed rule (84 FR
17580).
It is important to calculate average costs after removing any
regional differences that may be driven by wages, otherwise we would
over-adjust for wage differences across regions. For example, we remove
the wage differences in RHC costs by calculating the following value
for each hospice:
------------------------------------------------------------------------
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Adjusted RHC cost per day = (RHC cost per day from 2017 cost reports) *
(0.6871) / (Hospice's average wage index for all RHC days in FY 2017) +
(RHC cost per day from 2017 cost reports) * (1-0.6871)
------------------------------------------------------------------------
Note: 0.6871 is the labor share used to wage index adjust RHC payments.
We perform a similar calculation for the other levels of care using
the corresponding cost per day from FY 2017 cost reports and the
appropriate labor share for CHC, IRC, and GIP. For example, the
adjusted GIP cost per day uses the same formula, but instead includes
GIP cost per day from FY 2017 cost reports, the hospice's average wage
index for all GIP days in the formula, and the GIP labor share of 64.01
percent.
Due to exclusions mentioned previously, not all hospices that
submitted claims during FY 2017 have a corresponding cost report in our
final sample. As a result, the characteristics of the sample of cost
reports used to calculate average cost per day for each level of care
do not necessarily match up with the characteristics of all hospices
that submitted claims during FY 2017. If not accounted for, our sample
of cost reports may over represent certain types of hospices. To
correct for this, we categorize each hospice in our sample by facility
type,\10\ ownership type,\11\ urban/rural status,\12\ and size.\13\
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\10\ Freestanding versus provider-based.
\11\ We only divide the freestanding cost reports into ownership
type categories. We use the ownership type categories from the POS:
For-profit, government, non-profit, and other. Due to limited sample
size we do not break out the provider-based hospices into ownership
type.
\12\ Urban/rural status is reported on the POS and corresponds
to the mailing address of the hospice.
\13\ We divide hospices into three categories based on their
number of RHC days in FY 2017: Large (>=20,000 RHC days), medium
(3,500-19,999 RHC days), and small (0-3,499 RHC days).
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For each category of hospices and the calculations for each level
of care, we use the following steps:
1. Using claims, we compute the total number of days provided in FY
2017 by all hospices within a particular category;
2. We compute the total number of days, as reported on the claims
provided in FY 2017, using only the hospices in our trimmed sample of
cost reports within a particular category; and
3. For each level of care and each category of hospices, we
construct a ratio using the value in Step 1 over the value in Step 2.
For each cost report in our sample, we multiply each provider's
days (as reported on claims) by level of care by the ratio in order to
make the sample cost reports more representative of the overall
population of hospices. We then multiply the provider's average per
diem cost as reported on the cost report times the number of adjusted
days from the prior step to yield total costs by level of care for that
provider. We then compute the weighted average for each level of care
by summing across hospices the total costs by level of care divided by
the sum of the adjusted days across the cost reports in our sample.\14\
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\14\ The formula describes the average cost per day calculation
for IRC, however, the same formula can be adapted for each level of
care.
[GRAPHIC] [TIFF OMITTED] TR06AU19.028
Medicare pays for the CHC level of care using a per hour rate
instead of a per day rate. We calculated each hospice's hourly cost of
CHC by taking their CHC cost per day from the hospice cost report and
dividing it by their average number of hours of CHC provided on CHC
days occurring in FY 2017 as reported on each hospice's claims. Each
hospice's CHC cost per hour (adjusted by average number of hours of
CHC) is then averaged (using the weighted average formula discussed
above) across all hospices in our sample to create the overall average
of CHC cost
[[Page 38490]]
per hour. To convert the CHC cost per hour into a CHC cost per day we
multiply the average CHC cost per hour by 24 hours. It is important to
note that each hospice's hourly CHC cost is based on their average
number of CHC minutes per day, which is less than 24 hours. That means
a full CHC per day payment (which covers 24 hours) will be larger than
the average CHC cost per day (which covers a time period less than 24
hours). Applying all of the steps as described above and in the FY 2020
proposed rule, average costs per day by level of care in FY 2017 are
listed in Table 2 below:
Table 2--Average Cost per Day by Level of Care, FY 2017
------------------------------------------------------------------------
Average cost
Level of care per day
------------------------------------------------------------------------
RHC..................................................... $130.85
CHC (24 Hours).......................................... 1,307.76
CHC (Per Hour).......................................... 54.49
IRC..................................................... 441.03
GIP..................................................... 952.56
------------------------------------------------------------------------
The current payment system pays hospices a two-tiered rate for RHC.
RHC days during the first 60 days are paid a higher per diem rate
compared to any RHC days after day 60. Hospice do not report RHC costs
separately for the first 60 days versus RHC days after day 60. However,
we can estimate the RHC costs in the first 60 days versus after 60 days
by making the same assumption that was made to calculate the two-tiered
payment. That is, in the FY 2016 hospice final rule (80 FR 47166), we
calculated resource use ratios to determine the differences in resource
utilization for the first 60 days and any RHC days after day 60. For
the creation of the two-tiered RHC rate (80 FR 47166), the following
ratios were used:
Days 1 through 60: The ratio of average resource use for
RHC days in days 1 through 60 to average resource use across all RHC
days was 1.2603 to 1.
Days 61 and beyond: The ratio of average resource use for
RHC days after day 60 to the average resource use across all RHC days
was 0.8722 to 1.
We multiplied the labor share component of the average cost per day
for RHC in FY 2017 by the corresponding resource use ratio to calculate
the average cost per day for the first 60 days and any RHC days after
60 days. We only applied the resource ratio to the labor share
component because the resource ratio is calculated using minutes of
direct patient care as reported on the claims. This approach is
consistent with what was done in the FY 2016 hospice final rule (80 FR
47166) to construct the two-tiered payment. The resulting average cost
per day for RHC is shown in Table 3.
Table 3--Average RHC Costs
[FY 2017 per day for days 1 through 60 and days 61+]
----------------------------------------------------------------------------------------------------------------
Resource use
ratio (only
applied to the Average cost per
RHC level of care Average cost per labor share, day in FY2017
day which is 68.71% (based on days of
of the RHC RHC)
payment rate)
----------------------------------------------------------------------------------------------------------------
Days 1-60.............................................. $130.85 1.2603 $154.25
Days 61+............................................... 130.85 0.8722 119.36
----------------------------------------------------------------------------------------------------------------
To determine if there is any misalignment between the average costs
of providing CHC, IRC and GIP and the per diem payment rates for these
levels of care, we inflated the average costs in FY 2017 to FY 2019
dollars. We did this by multiplying the average FY 2017 costs by level
of care by the hospice market basket update for FY 2018 (82 FR 36649)
and FY 2019 (83 FR 38630) less the multifactor productivity (MFP)
adjustments corresponding to each year. The estimated average costs for
FY 2019 (that is, taking the average FY 2017 cost per day by each level
of care inflated to FY 2019 dollars) is detailed in Table 4.
Table 4--Estimated Average Costs (FY 2019) for CHC, IRC, and GIP
----------------------------------------------------------------------------------------------------------------
FY 2018 hospice FY 2019 hospice
market basket market basket
Level of care FY 2017 average update less update less FY 2019 estimated
costs productivity productivity average costs
adjustment adjustment
----------------------------------------------------------------------------------------------------------------
CHC (per Hour)...................... $54.49 x1.021 x1.021 $56.80
IRC................................. 441.03 x1.021 x1.021 459.75
GIP................................. 952.56 x1.021 x1.021 992.99
----------------------------------------------------------------------------------------------------------------
We also analyzed the average costs of RHC for the first 60 days and
any RHC days after day 60 inflated from FY 2017 dollars to FY 2019
dollars by applying the hospice market basket update for FY 2018 and FY
2019 less the MFP adjustments corresponding to each year. The estimated
average costs for RHC by days for FY 2019 is shown in Table 5 below.
[[Page 38491]]
Table 5--Estimated Average Costs for RHC (FY 2019) Days 1 Through 60 and Days 61+
----------------------------------------------------------------------------------------------------------------
FY 2018 hospice FY 2019 hospice
market basket market basket
Level of care FY 2017 average update less update less FY 2019 estimated
costs productivity productivity average costs
adjustment adjustment
----------------------------------------------------------------------------------------------------------------
RHC Days 1-60....................... $154.25 x1.021 x1.021 $160.80
RHC Days 61+........................ 119.36 x1.021 x1.021 124.43
----------------------------------------------------------------------------------------------------------------
We then compared the FY 2019 average costs for CHC, IRC and GIP to
the FY 2019 payment rates for these three levels of care. Our analysis
shows that there is a misalignment between average costs and payment
for these three levels of care. Table 6 below shows the percent of
total hospice days by level of care; the estimated average FY 2019
costs by level of care; the current FY 2019 per diem payment rates; and
the estimated percent increase to the payment rates to more accurately
align the per diem payments for CHC, IRC and GIP with the costs of
providing these levels of care.
Table 6--Comparison of FY 2019 Average Costs to Payments for CHC, IRC, and GIP
----------------------------------------------------------------------------------------------------------------
Estimated percent
Percent of days Estimated FY 2019 FY 2019 per diem payment increase
Level of care by level of care average costs per day payment rates needed to align
in FY 2018 * with costs
----------------------------------------------------------------------------------------------------------------
CHC.......................... 0.2 $1,363.26/$56.80 (per $997.38/$41.56 +36.6
hour).
IRC.......................... 0.3 $459.75................. 176.01 +161.2
GIP.......................... 1.3 $992.99................. 758.07 +31.0
----------------------------------------------------------------------------------------------------------------
* Note: We used the FY 2018 percent of days by level of care as this is the most current data available.
We also compared the FY 2019 average costs for RHC for the first 60
days and for any RHC days after day 60 to the FY 2019 payment rates for
RHC and the percentage difference between payment and average costs.
The percent difference between costs and payment represents how much we
would need to reduce the RHC payments in order to align payments with
costs. The results are shown in Table 7 below. However, we did not
propose to rebase the RHC payment rates as any changes to the CHC, IRC,
and GIP payment rates must be done in a budget-neutral manner as
required by law.
Table 7--Comparison of FY 2019 Average Costs to Payment for RHC
----------------------------------------------------------------------------------------------------------------
Percent
Estimated FY FY 2019 payment difference
Level of care 2019 average rates between costs
costs per day and payment
----------------------------------------------------------------------------------------------------------------
RHC Days 1-60.......................................... $160.80 $196.25 -18.1
RHC Days 61+........................................... 124.43 154.21 -19.3
----------------------------------------------------------------------------------------------------------------
3. Rebasing of the CHC, IRC, and GIP Payment Rates for FY 2020
As described in the proposed rule (84 FR 17582) and in this final
rule, the average costs of providing CHC, IRC and GIP are significantly
higher than the payment amounts for these three levels of care. Using
the hospice payment reform authority under section 1814(i)(6) of the
Act, in the FY 2020 proposed rule., we proposed to rebase the payment
rates for CHC, IRC, and GIP by setting these payment amounts equal to
the FY 2019 estimated average costs per day, as described in the
methodology above, before application of the hospice payment update
percentage outlined in section III.B.3 of this final rule. Using the
updated cost report and claims data as shown previously in this final
rule, the rebased payment rates for CHC, IRC, and GIP are as follows:
Table 8--Rebased Payment Rates for CHC, IRC, and GIP *
------------------------------------------------------------------------
Level of care Rebased payment rates *
------------------------------------------------------------------------
Continuous Home Care (CHC)................ $56.80 per hour/$1,363.26
(per day.**
Inpatient Respite Care (IRC).............. $437.86.***
General Inpatient Care (GIP).............. $992.99.
------------------------------------------------------------------------
* Prior to application of the hospice payment update of 2.6 percent
outlined in section III.B.3 of this final rule.
** Based on a full CHC per day payment (which covers 24 hours).
*** IRC payment rate accounts for 5 percent coinsurance ($459.75/1.05 =
$437.86).
Section 1813(a)(4)(A)(ii) of the Act states that the amount payable
for hospice care shall be reduced in the case of respite care provided
by (or under arrangements made by) the hospice program, by a
coinsurance amount equal to 5 percent of the amount estimated by the
hospice program (in accordance with regulations of the Secretary) to be
equal to the amount of payment under section 1814(i) to that program
for respite care. To ensure payments (both paid by Medicare and
collected from the beneficiary via coinsurance) under a rebased IRC
rate
[[Page 38492]]
equal the average per-diem cost of IRC, we set the rebased IRC payment
rate equal to the average per-diem cost of IRC divided by 1.05. The
amount of the individual's coinsurance liability for respite care
during a hospice coinsurance period may not exceed the inpatient
hospital deductible applicable for the year in which the hospice
coinsurance period began. The individual hospice coinsurance period
begins on the first day an election is in effect for the beneficiary
and ends with the close of the first period of 14 consecutive days on
each of which an election is not in effect for the beneficiary.
Section 1814(i)(6)(D)(ii) of the Act requires that any revisions to
the methodology for determining the payment rates for other services
included in hospice care to be done in a budget-neutral manner in the
fiscal year in which such revisions in payment are implemented as would
have been made for care in the fiscal year if such revisions had not
been implemented. The results of the calculations demonstrated in the
FY 2020 proposed rule (84 FR 17583) show that in order to rebase the
payment rates for the CHC, IRC, and GIP levels of care in a budget-
neutral manner, the RHC payment rates would need to be reduced by 2.71
percent. The 2.71 percent reduction would be applied to the RHC payment
rates for the first 60 days and RHC days after day 60. However, using
more recent claims data for this final rule, these same calculations
show that the actual reduction to the RHC payment rate would need to be
2.72 percent. To calculate the 2.72 percent reduction to the RHC
payment rates, we first calculated two sets of payments using different
payment parameters.
1. Total payments for hospice days provided during FY 2018 under
the existing FY 2019 payment rates and FY 2019 wage indices.
2. Total payments for hospice days provided during FY 2018 under a
new RHC payment rate and the rebased payment rates for CHC, IRC, and
GIP.
We set the RHC payment rate in step (2) equal to the value that
makes total payments between step (1) and step (2) equivalent. We
calculate that rate using the following steps:
1. We calculate the difference in Medicare payments when using the
rebased CHC, IRC, and GIP payment rates instead of the payment rates in
place during FY 2019.
2. We calculate one minus the value from Step (1) over the RHC
payments made under the payment rates in place during FY 2019.\15\
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\15\ Using the average per-diem costs generated from our sample
of freestanding hospice cost reports, rebasing CHC, IRC, and GIP
results in extra payments of $468,223,480.70 for those levels of
care. The RHC payments that were made under the payment rates in
place during FY 2019 were $17,238,380,386.58. One minus the value of
the extra payments over the RHC payments equals 0.9728.
---------------------------------------------------------------------------
3. We multiply the value in Step (2) by each RHC payment rate (the
first 60 days and any RHC days after day 60) in place during FY 2019 to
establish the budget-neutral RHC payment rates (the first 60 days and
any RHC days after day 60).
The calculated payment rates in Step (3) will make the total
payments made under the rebased FY 2019 payment rates equal to the
total payments made under the existing FY 2019 payment rates.
Essentially, the reduction is the weighted difference between non-RHC
costs and payments divided by the weighted RHC payments, where the
weights are the percent of days by level of care.
The results of this calculation demonstrate that in order to rebase
the payment rates for the CHC, IRC, and GIP levels of care in a budget
neutral manner, the RHC payment rates would need to be reduced by 2.72
percent. The 2.72 percent reduction would be applied to the RHC payment
rates for the first 60 days and RHC days after day 60 (that is, we
would take each of the RHC payment rates and multiply by the 0.9728 to
determine the FY 2019 RHC payment rates).
Therefore, in order to offset the increases in payment rates to the
CHC, IRC, and GIP levels of care, we would reduce the RHC payment rates
by 2.72 percent in order to implement rebasing in a budget-neutral
manner in FY 2020. However, reducing the RHC payment rate to a level
equal to the estimated RHC costs would require a reduction in the RHC
payment rate that exceeds the 2.72 percent. Therefore, while we are
rebasing the per diem payment rates for CHC, GIP, and IRC to more
accurately align the payment with costs, the reduction to the RHC
payment rates is not considered rebasing as the 2.72 percent reduction
does not bring the RHC payment in alignment with the costs of providing
this level of care. The purpose of the 2.72 percent reduction to the
RHC payment rates is to ensure that the revisions to the payment rates
for CHC, GIP and IRC are made in a budget-neutral manner, in accordance
with the law.
We received 113 unique comments regarding the rebasing methodology
and analysis, as well as the rebased payment rates for CHC, IRC, and
GIP. Most of these comments were from hospices, industry associations
and other relevant stakeholders, including comments from the Medicare
Payment Advisory Commission (MedPAC). These comments are summarized
below along with our responses:
Comment: Several commenters were supportive of CMS' proposal to
rebase the per diem payment amounts for CHC, GIP and IRC in order to
ensure that payments are closer to the estimated cost of providing each
level of care. Commenters stated that rebasing the rates for these
three levels of care addresses concerns that hospices lose money on the
increased costs of providing more complex medical management. These
commenters stated that hospices often have to pay contractors and the
facilities providing this increased level of care more than the payment
rates the hospices are currently receiving. Further, commenters
suggested that, were CMS to finalize this proposal, the potential
increase in availability of hospices to provide these levels of care
would benefit patients and their caregivers. A few commenters stated
that rebasing the CHC, GIP, and IRC rates would benefit rural hospices
who have fewer facilities and contractors with which to provide this
care.
Response: We thank commenters for their thoughtful review and
support of our efforts to better align hospice costs of providing care
for patients receiving CHC, GIP, and IRC and to support hospices
working with outside contractors and facilities. We agree that rebasing
these rates would adequately cover the costs of providing these higher
intensity levels of care, could ensure that hospices have access to the
providers needed to comply with the hospice Conditions of Participation
(CoPs), and promote patient access to all levels of care.
Comment: CMS received several comments about the large number of
cost reports eliminated with exclusion 2 (that is, we eliminated SNF,
HHA and hospital cost reports that did not contain a hospice CCN) and
as reported in Table 2 of the proposed rule (84 FR 17578). Many
commenters also mentioned that CMS used cost reports for FY 2017 and
applied Level I edits; however, the edits went into effect for cost
reporting periods that ended on or after December 31, 2017. These
commenters expressed concern that CMS applied the Level I edits to
freestanding and provider-based cost reports even though the edits were
not applicable to provider-based cost
[[Page 38493]]
reports for 2017 or subsequent cost reports thus stating we shouldn't
use them in our analysis. Several commenters recommended that CMS
include provider-based cost reports as the sample size used for the
analysis and methodology is relatively small. These commenters
suggested that using larger sample of cost reports by incorporating
cost reports from provider-based hospices when rebasing CHC, IRC and
GIP per diem rates would provide more robust and accurate information.
Response: For the FY 2020 final rule, CMS updated the FY 2017 cost
reports using the hospice cost report file https://downloads.cms.gov/Files/hcris/HOSPC14-ALL-YEARS.zip from the proposed rule (84 FR 17578).
There are 4,195 hospice cost reports as of June 21, 2019 versus 4,125
from the proposed rule. We describe, in detail, in this final rule and
in the FY 2020 hospice proposed rule (84 FR 17570), all of the
exclusions applied to hospice cost reports to estimate the average cost
per day by level of care. And in this final rule, we remind commenters
that the final sample of cost reports is higher than described in the
proposed rule (1,232 cost reports for this final rule compared to 1,120
in the proposed rule). We note that most SNFs do not have a hospice CCN
associated with it, so most of the SNF cost reports were dropped. We
believe that eliminating these SNF cost reports with no associated
hospice CCN would more accurately filter out those costs not related to
the cost of providing hospice care and where much of the reported costs
may be for the provision of SNF services. Additionally, we considered
proposing to use freestanding and provider-based cost reports to rebase
CHC, IRC, and GIP payment rates, rather than just using freestanding
cost reports. However, when we analyzed both freestanding and provider-
based cost reports, the results tend to be similar. On average,
incorporating provider-based cost reports results in higher costs than
the cost reports for freestanding hospices only, as shown in Table 27
of the FY 2020 hospice proposed rule (84 FR 17616).
Similarly, when we rebased the national, standardized 60-day
episode payment rate for home health agencies beginning in CY 2014, we
estimated costs using only freestanding HHA cost reports for the same
reasons detailed in the FY 2020 hospice proposed rule (that is,
freestanding cost reports reflect actual hospice costs and not those
additional costs borne from the parent entity). Therefore, it is not
unprecedented in Medicare payment systems to use only freestanding cost
reports, rather than including provider-based cost reports for rebasing
purposes.
Additionally, in MedPAC's March 2018 report to Congress, MedPAC
stated that overhead costs allocated from the parent provider are
included in the costs for provider-based hospices, which contributes to
provider-based hospices having higher costs than freestanding hospices.
If freestanding hospices are able to provide high-quality care at a
lower cost than provider-based hospices, payment rates should be set
accordingly, and the higher costs of provider-based hospices should not
be a reason for increasing Medicare payment rates. Ultimately, we used
freestanding cost reports to estimate the average cost per day by level
of care.
As detailed in the FY 2020 proposed rule, we also applied Level I
edits (and removed certain reports with missing data from our sample)
manually because not all FY 2017 freestanding cost reports had a
reporting period that ended on or after December 31, 2017. We decided
to apply Level I edits based on suggestions by industry representatives
to apply certain edits to force adherence to certain cost-reporting
principles that could lead to the reporting of higher-quality cost
data. Therefore, we believe it is most technically appropriate to apply
the Level I edits. Furthermore, we show in Table 26 of the proposed
rule (84 FR 17616) that the differences in costs between including and
not including exclusions based on the Level I edits were minimal for
RHC, CHC, and GIP. The difference between applying Level I edits versus
not applying the edits is less than one dollar for RHC, CHC, and GIP.
However, the IRC cost per day between the two trimming methodologies
was more pronounced, but still not significantly so. In looking at FY
2017 estimated average per day costs using all of the trimming
exclusions, and as shown in Table 26 in the proposed rule, the cost for
IRC was $438.97; applying all of the trimming exclusions, excluding the
Level I edits, the cost for IRC was $467.78 (a 6.6% increase).
Therefore, for purposes of estimating the costs by level of care, we
believe that applying the Level I edits is appropriate given these
edits are now applied for hospice cost reports and there was minimal
effect on the average costs per day.
Comment: Several commenters stated that many hospices do not
accurately or consistently complete cost reports, thus rendering the
data inaccurate. These commenters stated that because of the
inaccuracies in the cost reports, CMS should not use hospice cost
reports as the source of data to estimate costs. Several commenters
mentioned concerns about the accuracy of the cost report data in the FY
2017 cost reports that CMS used for their analysis and methodology. A
few commenters stated that CMS did not provide additional information
about which provider's data was used.
Response: We remind hospices that each hospice cost report is
required to be certified by the medical officer or hospice
administrator. The hospice Medicare Cost Report (MCR) form (CMS-1984-
14) includes a dated and signed statement indicating that all
information is true, correct, and prepared from the books and records
of the provider in accordance with applicable instructions, except as
noted. Additionally, as required by section Sec. 413.24(f)(4)(iv)(A)
the cost report must be signed by either the Chief Financial Officer or
the Administrator. If there are errors within a cost report, they must
be filed on time and if there is any type of problem with it that
cannot be addressed timely, the MAC may withhold Medicare payments.
Therefore, we expect and it is required that hospice cost reports
contain accurate and complete data on which to base our analyses.
As always, we encourage providers to fill out the Medicare cost
reports as accurately as possible. The Provider Reimbursement Manual
\15\ provides detailed instructions on filling out the cost reports.
CMS further encourages hospice providers to contact the appropriate
Medicare Administrative Contractor (MAC) if additional instruction or
assistance is needed. Furthermore, as the cost reports are to reflect
all of the costs associated with providing hospice care by level of
care, we believe that it is the most appropriate mechanism in which to
estimate costs for rebasing payment rates.
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\15\ The Provider Reimbursement Manual--Part 2. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Paper-Based-Manuals-Items/CMS021935.html.
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Our cost report analysis was based on information obtained from the
Healthcare Cost Report Information System (HCRIS). As mentioned in the
proposed rule (84 FR 17578), the hospice cost report data contains cost
and statistical data for freestanding and provider-based hospice
providers. For the proposed rule, we used HCRIS data files from
December 31, 2018. For this final rule we used more up to date cost
report data from March 31, 2019. The updated data contains 4,195
hospice cost reports versus 4,125 from the
[[Page 38494]]
proposed rule. In our analysis, we used Worksheet S-2 to determine if
the provider-based cost reports had a hospice CCN. Information
regarding costs per day by level of care came from worksheet O8 for
provider-based cost reports and worksheet C for freestanding cost
reports. Information needed to construct the level I edits came from
worksheet A for freestanding cost reports and worksheet O and O5 for
provider-based cost reports. We feel confident that the cost reports
that the hospice providers submit are accurate and that the signatures
obtained by the administrator and or Officer are true, correct,
complete, and prepared from the books and records of the provider in
accordance with applicable instructions.
Comment: Several commenters disagreed with the proposal to rebase
the CHC, IRC, and GIP payment rates stating that the reduction in the
RHC payment rate in order to maintain budget neutrality effectively
turns the rebasing proposal into a rate cut even after the proposed
payment update. These commenters stated that this would create
financial and staffing hardships for hospices, especially smaller rural
hospices. Some commenters stated that payment adjustments that more
accurately capture and compensate for differences in costs of providing
hospice services in rural versus urban communities may first be
necessary before CMS rebases payment rates. A few commenters stated
that the effect of rebasing will be felt unevenly across providers,
depending on the amount of GIP, CHC and IRC being provided by an
individual hospice and that CMS should ensure that payment adjustments
adequately account for differences in costs based on geography.
Response: Section 1814(i)(6)(D)(ii) of the Act requires that any
revisions to the hospice payment rates be done in a budget neutral
manner. Meaning the revisions in payment for GIP, IRC and CHC must
result in the same estimated aggregate expenditures had the revisions
not been implemented. After applying the FY 2020 hospice payment update
of 2.6 percent and accounting for the rebasing of the GIP, IRC and CHC
payment rates (which requires a 2.72 percent reduction to the RHC
payment rate) the net result would only be a reduction of 0.19 percent
to the RHC payment rate. That reduction equates to approximately 37
cents on RHC days 1 through 60 and 29 cents on days 61 plus (compared
to the FY 2019 RHC payment rates). Given that MedPAC in their recent
March 2019 Report recommended a 2 percent reduction to the hospice base
payment rates and projects Medicare hospice margins to be 10.1 percent
for 2019, we feel the reduction to the RHC payment rate would not
create financial hardships for hospices. Furthermore, in their March
2019 report, and their comments on the proposed rule, MedPAC reported
that the aggregate 2016 Medicare margin, which is an indicator of the
adequacy of Medicare payments relative to providers' costs, was 10.9
percent, up from 9.9 percent in 2015. They stated that hospice costs
per day vary substantially by type of provider, which is one reason for
differences in hospice margins across provider types. In 2016, hospice
costs per day across all hospice providers were about $149 on average,
a slight decrease from $150 in the previous year. Some of the decline
in cost per day is accounted for by a shift in the mix of hospice days,
with the share of days accounted for by routine home care (the lowest
cost level of care) increasing in 2016. Freestanding hospices had lower
costs per day than provider-based hospices (that is, home health-based
hospices and hospital based hospices). For-profit, above-cap, and rural
hospices also had lower average costs per day than their respective
counterparts.
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 Office of Management and Budget (OMB) to
the Metropolitan Statistical Areas (MSAs) definitions. 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. Overall, rural
hospices would have a slight decrease (estimated to be less than 1
percent) in payments as a result of the rebased payment rates for CHC,
GIP, and IRC. However, rural, non-profit HHAs will see an increase in
payments, compared to rural for-profit HHAs who will see a slight
decrease in payments as a result of the rebased rates.
Comment: Several commenters, including a national industry group,
agreed that while the CHC, IRC, and GIP payment rates need to be
increased, they expressed concern that CMS needs to examine any
negative impact on access to care.
Response: We disagree that increasing the rates for CHC, IRC, and
GIP would have a negative impact on access to care. Conversely, we
believe that aligning the payment with the cost of providing care
should have a positive effect on access to needed levels of care. We
believe that hospices who currently cannot provide adequate CHC will
now have the resources to hire adequate staff to ensure patients
needing CHC level of care will have the needed nursing support during a
time of symptom crisis. Likewise, for those hospices who do not have
their own freestanding, inpatient unit, we believe the higher payment
rates for IRC and GIP will afford them more latitude when negotiating
contracts with skilled nursing facilities and hospitals to best meet
the needs of their patients requiring inpatient levels of care.
However, 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.
Comment: Many commenters suggested to postpone any rebasing for 2
years so that CMS has enough time to validate cost reports and accuracy
of data to support the changes, or at the very least, implement a
phased-in approach to increasing the payment rates for CHC, IRC, and
GIP payment rates and reducing the RHC payment rates.
Response: While we understand why some hospices would prefer to
postpone or phase-in rebasing of the CHC, IRC, and GIP payments and the
corresponding reduction to RHC payments to maintain budget neutrality,
we disagree with either of these approaches as this would not align
payment with the costs of providing the higher intensity levels of
care.
We will continue to monitor utilization with implementation of
these rebased rates to see if there are any trends that may warrant
other appropriate actions, including program integrity measures.
Furthermore, a phased-in approach would require a recalculation of the
RHC amount each year based on the most recent utilization of CHC, IRC
and GIP. If there was an increase in utilization of those levels (CHC,
IRC, GIP) we would then have to further adjust the RHC rate to account
for the increase in utilization, which could further reduce the RHC
rate. Likewise, even with the 2.72 percent reduction to the RHC rates,
the payment for both days 1-60 and days 61+ still exceeds the cost of
providing this level of care, as shown in Table 7 in this final rule.
Comment: Several commenters noted that the changes to the IRC per
diem payments would make it easier to
[[Page 38495]]
provide respite care to patients and their families needing such
support. One commenter noted that the rebasing of GIP would have a
positive impact on those hospices that provide GIP in their own
freestanding facilities. Hospice providers stated that this change
would allow their freestanding facility to operate with positive
margins for the first time. Other commenters remarked that the
increased IRC rates will enable them to find nursing facilities willing
to contract with them for respite stays. A large number of commenters
stated that upward adjustment for CHC, GIP, and IRC is warranted given
the misalignment between payment and costs.
Response: We appreciate these comments and agree that rebasing the
IRC payment rate may result in greater access to inpatient respite care
for terminally ill patients and their families. Likewise, the rebasing
proposals help to align payment with the cost of providing care and we
believe that this proposal is responsive to industry concerns and
challenges related to providing these higher intensity levels of care.
Comment: Many hospices, along with MedPAC, noted concerns about
creating incentives for hospices to improperly expand the use of
inpatient levels of care as a result of rebasing. They suggested
considering a prospective payment adjustment to GIP to maintain budget
neutrality if aggregate payments increase as a result of these payment
changes. MedPAC also expressed concern about the proposed increase in
the GIP payment rate provided in a skilled nursing facility (SNF) and
urged CMS to maintain the current payment rate of GIP provided in SNFs.
MedPAC cited reports from hospice providers that it costs less to
contract for GIP in a SNF than with a hospital. A few other commenters
suggested that CMS reconsider increasing the GIP per diem payment rate
in skilled nursing facilities (SNFs). They suggested that an increase
in the payment rate for GIP would likely make providing GIP in SNFs
quite profitable and could create incentives for more hospice providers
to furnish GIP in SNFs. They further note that GIP care in the SNF
setting tends to be less resource intensive and less costly than in a
hospital or hospice facility.
Response: We believe that the rebased rates will help appropriately
increase access to care but we are aware of the perverse incentives
that could occur with increases in payment rates. We recognize that
there may be an increase in utilization of these higher intensity
levels of care but we believe that this may be appropriate to meet
patient care needs. We remind stakeholders that there are criteria for
receiving these higher levels of care which may potentially buffer any
inappropriate increases in utilization. Continuous home care may be
provided only during a period of crisis as necessary to maintain an
individual at home. Either homemaker or home health aide (hospice aide)
services or both may be covered on a 24-hour continuous basis during
periods of crisis but care during these periods must be predominantly
nursing care. A period of crisis is a period in which a patient
requires continuous care to achieve palliation or management of acute
medical symptoms. The hospice must provide a minimum of 8 hours of care
during a 24-hour day, which begins and ends at midnight. This care need
not be continuous; for example, 4 hours could be provided in the
morning and another 4 hours in the evening. In addition to the 8 hour
minimum, the services provided must be predominantly nursing care,
provided by either an RN, an LPN, or an LVN. Respite care is short-term
inpatient care provided to the individual only when necessary to
relieve the family members or other persons who normally care for the
individual at home. Respite care may be provided only on an occasional
basis and may not be reimbursed for more than 5 consecutive days at a
time. Payment for the sixth and any subsequent day of respite care is
made at the routine home care rate, and the patient would be liable for
room and board. Respite care cannot be provided to hospice patients who
reside in a facility (such as a long term care nursing facility).
Provision of respite care depends upon the needs of the patient and of
the patient's caregiver (and is subject to the regulatory limitations
set out at Sec. 418.302(e)(5)). And finally, GIP is allowed when the
patient's medical condition warrants a short term inpatient stay for
pain control or acute or chronic symptom management that cannot
feasibly be provided in other settings.
To address MedPAC and other stakeholder comments regarding the
difference in the provision of GIP in a SNF compared to an inpatient
hospital, we note the current cost report does not allocate costs for
GIP by site of service. Additionally, our analysis has shown that very
few GIP days are provided in a SNF compared to other freestanding
facilities and inpatient hospitals. Likewise, the types of hospices
providing GIP in a SNF may be different in other ways compared to
hospices that do not provide GIP in a SNF. It is possible those
differences are correlated with the costs.
Additionally, we continue to expect hospices to provide care in
accordance with the individualized plan of care as required by the
hospice CoPs at Sec. 418.56. This means that we do not expect that
hospices would move patients into higher intensity levels of care
solely to receive higher payments. As mentioned in the proposed rule,
we believe that rebasing the per diem payment amounts for CHC, GIP, and
IRC is appropriate in order to align payments with cost of providing
care. Likewise, potential, subsequent increases in utilization would
not necessarily be inappropriate. Hospice providers still need to meet
the necessary requirements stated in section 1861(dd) of the Act and
the hospice CoPs, which require that hospice agencies regardless of
size, location or other organizational or market characteristics must
be able to provide all four levels of hospice care. As part of our
routine monitoring of hospice utilization, we will continue to closely
analyze any changes in the patterns of care in response to these
rebased payment rates to determine if any additional actions are
warranted.
Comment: Several commenters suggested that CMS should increase its
oversight of hospice providers not delivering the services required
under the hospice CoPs and exhibiting inappropriate practices
highlighted by the OIG and the MedPAC.
Response: We note that compliance with the hospice CoPs is
monitored through the survey process. The IMPACT Act of 2014 currently
requires hospice survey/recertifications every 3 years. Survey
protocols and Interpretive Guidelines are established to provide
guidance to personnel conducting surveys of hospices. They serve to
clarify and/or explain the intent of the regulations. All surveyors are
required to use them in assessing compliance with federal
requirements.\16\ There are different types of surveys including survey
for initial certification for participation in Medicare; a
recertification survey which are unannounced and must verify compliance
with all the regulatory requirements contained at Sec. Sec. 418.52
thru 418.116; a post-survey onsite revisit is to reevaluate the
specific care and services that were cited during a previous survey
that cannot be adequately assessed by mail, telephone
[[Page 38496]]
or electronic contact, or; a complaint investigation in which a survey
is conducted to investigate and resolve a complaint against a hospice.
We believe that there are already systems in place to ensure compliance
with the hospice CoPs and we will continue to coordinate with the State
Agencies to identify any ongoing concerns as they relate to the CoPs
and to determine whether any additional oversight mechanisms need to be
in place. We are committed to encouraging providers to supply the best
quality care in the most appropriate ways, and we will continue to work
to incentivize and monitor for the most appropriate practices in the
hospice provider community.
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\16\ State Operations Manual Appendix M--Guidance to Surveyors:
Hospice. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_m_hospice.pdf.
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Comment: Several commenters expressed concern that increasing the
rates for IRC and GIP will result in contracted facilities raising the
rates they charge hospices to provide these levels of care.
Stakeholders remarked that these are essentially ``pass-through
payments'' to contracted providers and would require hospice providers
to bear the cost of providing these services while taking a large
reduction to the RHC reimbursements. Some commenters stated that IRC
and GIP can be supplied by hospice in various ways resulting in wide
differences in costs for providing these levels of care. Commenters
asserted that a small proportion of hospices operate hospice inpatient
units directly, while some others are system or SNF-based and secure
inpatient care through a parent entity. They suggested that the vast
majority of hospice providers, more than 75 percent, enter into
contracts with local hospitals or other facilities and therefore costs
for inpatient days vary significantly. One commenter suggested that the
estimated cost of IRC reported in the proposed rule does not accurately
reflect the average cost of providing this level of care as it is being
affected by high cost outliers and therefore the rebased payment rate
may be inaccurate.
Response: We remind stakeholders that CMS does not have the
authority to mandate specific contractual agreements between hospices
and other entities which have entered into an agreement to provide
arranged hospice services. Hospices are required, in accordance with
the CoPs at Sec. Sec. 418.100 and 418.108, to be able to provide all
levels of hospice care. This means it is the responsibility of hospices
to secure the necessary contracts to provide inpatient levels of care
if the hospice does not provide them in their own freestanding
facility. As such, hospices would have to negotiate appropriate rates
with the contracted providers to ensure that the hospice has sufficient
resources to provide the necessary care.
To address the comment about IRC cost outliers, in the proposed
rule, we trimmed the top and bottom 1 percent of cost reports, which
excluded some outliers and have done so for the final rule. We
recognize that IRC does have a wide distribution with outliers (even
after taking out the top and bottom 1 percent). While there may be some
high-cost outliers that affect the estimated, average cost of IRC, we
remind stakeholders that utilization of IRC is low, accounting for 0.3
percent of total hospice days and it would not take many outliers to
impact the estimated costs of providing this level of care. As such, we
would not want to make any further exclusions to only one particular
level of care. Additionally, we note that the rebased payment rate for
IRC excludes the 5 percent coinsurance for each day of respite care.
However, commenters on the proposed rule stated that most hospices do
not collect this coinsurance from beneficiaries. Therefore, overall
payment to hospices for IRC is even further reduced in those
circumstances when hospices do not collect this coinsurance.
Final Decision: After considering the comments received in response
to the proposed rule and for the reasons discussed above, we are
finalizing our proposal to rebase the payment rates for CHC and GIP and
set these rates equal to their average FY 2019 costs per day as shown
in Table 8 of this final rule. We are finalizing rebasing of IRC
payment rates and setting this rate 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, also as shown in Table
8 of this final rule. Lastly, we are finalizing a 2.72 percent
reduction to the RHC payment rates 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.
B. FY 2020 Hospice Wage Index and Rate Update
1. Wage Index Lag Elimination
Historically, we have calculated the hospice wage index values by
using the prior fiscal year's pre-floor, pre-reclassified hospital wage
index. In an effort to align with the Inpatient Prospective Payment
System (IPPS) and other payment systems, in the FY 2020 hospice
proposed rule (84 FR 17584), we proposed to change the hospice wage
index methodology. Specifically, we proposed to change from our
established policy of using the pre-floor, pre-reclassified acute care
hospital wage index from the prior fiscal year as the basis for the
hospice wage index, and instead to align with the same timeframe used
by the IPPS and other payment systems. In other words, we proposed to
use the pre-floor, pre-reclassified hospital wage index from the
current fiscal year as the basis for the hospice wage index. Under this
proposal, the FY 2020 hospice wage index would be based on the FY 2020
pre-floor, pre-reclassified IPPS hospital wage index rather than on the
FY 2019 pre-floor, pre-reclassified IPPS hospital wage index.
Using the concurrent pre-floor, pre-reclassified hospital wage
index would result in the most up-to-date wage data being the basis for
the hospice wage index, increasing payment accuracy. It would also
result in more consistency and parity in the wage index methodology
used by Medicare. Medicare's skilled nursing facility (SNF), home
health and inpatient hospital prospective payment systems already use
the most current wage index data as the basis for their wage indices.
Thus, the wage-adjusted Medicare payments of various provider types
would be based upon wage index data from the same timeframe. We are
considering similar policies to use the concurrent pre-floor, pre-
reclassified hospital wage index data in other Medicare payment
systems, such as inpatient psychiatric facilities and inpatient
rehabilitation facilities.
Overall, the impact between the FY 2020 wage index with the 1-year
lag and the proposed FY 2020 wage index removing the 1-year lag is 0.0
percent due to the wage index standardization factor, which ensures
that wage index updates and revisions are implemented in a budget-
neutral manner. The anticipated impact on Medicare hospice payments due
to the change in the wage index methodology can be found in Table 9
below.
BILLING CODE 4120-01-P
[[Page 38497]]
[GRAPHIC] [TIFF OMITTED] TR06AU19.029
[[Page 38498]]
[GRAPHIC] [TIFF OMITTED] TR06AU19.030
BILLING CODE 4120-01-C
2. FY 2020 Hospice Wage Index
The hospice wage index is used to adjust payment rates for hospice
agencies 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 Office of Management and
Budget (OMB) to the Metropolitan Statistical Areas (MSAs) definitions.
In the FY 2020 proposed rule (84 FR 17586), we proposed to use the
current FY's hospital wage index data to calculate the hospice wage
index values. For FY 2020, the proposed hospice wage index would be
based on the FY 2020 hospital pre-floor, pre-reclassified wage index.
This means that the hospital wage data used for the hospice wage index
are not adjusted to 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 2020, the only CBSA without a hospital from which hospital wage
data can be derived is 25980, Hinesville-Fort Stewart, Georgia. The FY
2020 wage index value Hinesville-Fort Stewart, Georgia is 0.8322.
Please note that CBSA 16180 Carson City, NV had no provider wage data
for the FY 2020 proposed hospice rule (84 FR 17586). However, this CBSA
now has provider wage data for the updated final wage index file. The
new wage index value for CBSA 16180 is 1.0070.
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
[[Page 38499]]
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 2020, 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. Pre-
floor, pre-reclassified hospital wage index values below 0.8 are
adjusted by a 15 percent increase subject to a maximum wage index value
of 0.8. 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.
We identified a slight error in the proposed rule wage index values
after the FY 2020 Hospice Wage Index and Payment Rate Update proposed
rule was published. A programming error caused the data for all
providers in a single county to be included twice, which affected the
national average hourly rate, and therefore affected nearly all wage
index values. We have changed the programming logic so this error
cannot occur again. In addition, we corrected the classification of one
provider in North Carolina that was erroneously identified as being in
an urban CBSA. We also standardized our procedures for rounding, to
ensure consistency. The correction to the proposed rule wage index data
was not completed until after the comment period closed June 18, 2019.
This final rule reflects the corrected and updated wage index data. The
final hospice wage index applicable for FY 2020 (October 1, 2019
through September 30, 2020) is available on our website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index.html.
We received approximately 22 comments on the FY 2020 hospice index
proposals from various stakeholders including hospices, national
industry associations and MedPAC. A summary of these comments and our
responses to those comments appear below:
Comment: Several commenters expressed support for the wage index
lag elimination. Several commenters stated that changing the lag with
the Hospital Wage Index will help hospices be more competitive in the
labor market, allow wages to track closer to market shifts, and allow
hospices to compete in tight labor markets. One commenter expressed
support for CMS' efforts to eliminate differences between provider
types by removing the time lag. A few commenters suggested the proposed
changes to the wage index calculations would provide consistency with
the other Medicare payment systems. One commenter suggested that the
existing lag makes it difficult for agencies and companies operating in
multiple states. One commenter stated that there is value in
consistency across provider types so that all providers can compete in
same labor pool. The commenter further asserted that hospices may be
able to provide input to hospitals on proposed wage index values. One
commenter expressed support for eliminating the lag year and recognizes
the value in having wage index consistency across provider types to
enhance the ability of all employers in a given area to compete for
staff from the same labor pool. The commenter further asserted that
elimination of the lag year also provides some potential for hospices
to provide input to local hospitals when proposed wage index values
appear to undervalue the cost of labor in a geographic area.
Response: While we appreciate the commenters' careful review of the
proposal and the support for the removal of the wage index lag
elimination, we reiterate that using the most current year's data will
most accurately adjust payment to account for geographic wage
differences.
Comment: Several commenters suggested utilizing a transitional year
wage index value that is a 50-50 blend of the lag year value and FY
2020 wage index value. One commenter suggested that a transitional wage
index would provide some relief from substantial negative impact that
many providers would experience by going directly to the FY 2020 wage
index. The commenter further asserted that wage index values for the
other regions under a blend would still exceed the values they would
have been assigned in FY 2019. One commenter recommended a phase-in to
the removal over multiple years to minimize the disruption of the
impact on the industry. The commenter further asserted that a phase-in
is appropriate given the significant redistribution created by the
proposed change. One commenter stated that while not opposed to
removing the 1-year lag as other types use the most current wage index
in calculating their indices, the commenter is concerned that the
proposed rule does not provide additional adjustments.
Response: While we appreciate commenters' suggestion to create a
transitional wage index that is a 50-50 blend of FY 2019 and FY 2020
wage index values, we believe that it is important to use the most
recent data to increase payment accuracy. We also believe it is
important to stay in alignment with other CMS payment systems so that
there is parity and consistency in the wage index methodology.
Comment: A few commenters expressed concern that removing the 1-
year lag would have a negative impact on hospices. One commenter
suggested that removing the lag would have a negative short-term impact
on hospices due to a shorter time period for providers to plan in cases
where the wage index drops substantially. One commenter stated that the
current 1-year lag allows hospices to plan for wage index changes which
would be far more difficult if changes were based on the current year's
wage index. One commenter stated that the proposal disadvantages
providers because they would no longer have advance warning of wage
index changes. The commenter further asserted that providers will be
unable to plan for any significant shifts (particularly negative
shifts). One commenter stated that elimination of the lag year allows
hospices a much shorter period of time to adapt or adjust their
financial expectations and absorb the impact of negative wage index
swings, particularly swings under which the wage index value for an
area drops precipitously.
Response: We disagree that removing the 1-year lag would have a
negative impact on hospices and we refer commenters to Table 9 of this
final rule to see the impact with and without the 1 year wage index
lag. We continue to believe that using the most current year's wage
index would improve overall payment accuracy.
Final Decision: After considering the comments we received on the
elimination of the wage index lag, we
[[Page 38500]]
are finalizing the removal of the 1 year wage index lag. We are
finalizing that we will use the current year's wage index to
geographically wage adjust hospice payments, so for the FY 2020 hospice
per diem payment rates, these will be geographically wage-adjusted
using the FY 2020 wage index. Using the most current up to date
information will increase payment accuracy and result in more
consistency and parity in the wage index methodology used by Medicare.
We also received comments on the hospice wage index in general and
these are summarized below, along with our responses.
Comment: Several commenters suggested that providers be guaranteed
a wage index value that does not drop below the rural wage index
applicable in their state of operation.
Response: The hospice wage index does not contain a rural floor
provision. Section 4410(a) of the Balanced Budget Act of 1997 (Pub. L.
105-33) provides that the area wage index applicable to any hospital
that is located in an urban area of a state may not be less than the
area wage index applicable to hospitals located in rural areas in that
state. This rural floor provision is specific to hospitals. Because the
hospital rural floor applies only to hospitals, and not to hospices, we
continue to believe the use of the pre-floor and pre-reclassified
hospital wage index results in the most appropriate adjustment to the
labor portion of the hospice payment rates. This position is
longstanding and consistent with other Medicare payment systems (for
example, SNF PPS, IRF PPS, and HH PPS). The hospice floor is applicable
to all CBSAs, both rural and urban. Pre-floor, pre-reclassified
hospital wage index values below 0.8 are adjusted by a 15 percent
increase subject to a maximum wage index value of 0.8.
Comment: One commenter expressed concern that hospitals currently
receive special consideration in a number of ways, but hospices and
other small provider types are not granted the same considerations. The
commenter suggested that creating value that is consistent across
provider types will ensure that providers can compete in same labor
pool. One commenter expressed concern that the current wage index
system does not provide parity to all providers competing for the same
professionals from the same labor pool. One commenter expressed concern
that hospitals are allowed to reclassify and post-acute care facilities
are at a disadvantage when competing for employees. The commenter
suggested that until CMS can create a hospice specific wage index
methodology, CMS should equalize rates between hospitals and post-acute
care. One commenter expressed concern that while the same data are used
to establish the basic wage index values applicable to most provider
types, hospitals are permitted to seek geographic reclassification from
their assigned geographic area (thereby receiving higher wage
adjustments to their payments).
Response: The current statute and regulations that govern the
hospice payment system do not currently provide a mechanism for
allowing hospices to seek geographic reclassification. The
reclassification provision is found in section 1886(d)(10)(C)(i) of the
Act, which states, ``The Board shall consider the application of any
subsection (d) hospital requesting that the Secretary change the
hospital's geographic classification . . .'' This provision is only
applicable to hospitals as defined in section 1886(d) of the Act. In
addition, we do not believe that using hospital reclassification data
would be appropriate, as these data are specific to the requesting
hospitals and they may or may not apply to a given hospice.
Comment: One commenter expressed concern that wage index values, at
some times and in some localities, are subject to significant year-to-
year swings. This volatility has a disproportionate impact on not-for-
profit hospice programs that have smaller operating margins and
therefore less ability to absorb large cost swings. One commenter
expressed appreciation for adjustments in wages that recognize the need
to recruit and contain a stable workforce for hospice. However, the
commenter also expressed concern that for programs with tight margins,
the continued compression of rates will result in more limited choices
of hospice providers, particularly in rural areas and non profit
hospices. One commenter expressed concern that hospice payment rules
adopt the hospital wage index (HWI) of the Medicare Inpatient Hospital
Prospective Payment Systems (IPPS) which can make Medicare payments to
Hospices volatile when there are changes in the hospital wage costs,
particularly in rural communities. The commenter further asserted that
the HWI is threatening the financial stability of several hospices in
Washington State and potentially across the country, including
precipitous reductions in Medicare reimbursement having nothing to do
with local factors, but triggered instead by organizational changes at
nearby hospitals. The commenter suggested that the wage index should be
based on wages and hours of labor directly tied to Medicare Part A
services. One commenter stated that the wage index varies for their
southern service areas, with significant year to year swings. One
commenter expressed concern that providers experience swings in wage
index values from year to year, and they are often surprised by the
variation in their rates.
Response: The annual changes in the wage index reflect real
variations in costs of providing care in various geographic locations.
We utilize efficient means to ensure and review the accuracy of the
hospital cost report data and resulting wage index. The hospice wage
index is derived from the pre-floor, pre-reclassified wage index, which
is calculated based on cost report data from hospitals. All Inpatient
Prospective Payment System (IPPS) hospitals must complete the wage
index survey (Worksheet S-3, Parts II and III) as part of their
Medicare cost reports. Cost reports will be rejected if Worksheet S-3
is not completed. In addition, our Medicare contractors perform desk
reviews on all hospitals' Worksheet S-3 wage data, and we run edits on
the wage data to further ensure the accuracy and validity of the wage
data. Our review processes result in an accurate reflection of the
applicable wages for the areas given. In addition, we finalized a
hospice wage index standardization factor in FY 2017 (81 FR 52156) to
ensure overall budget neutrality when updating the hospice wage index
with more recent hospital wage data. Applying a wage index
standardization factor to hospice payments will eliminate the aggregate
effect of annual variations in hospital wage data. Our policy of
utilizing a hospice wage index standardization factor provides a
safeguard to the Medicare program as well as to hospices because it
will mitigate fluctuations in the wage index by ensuring that wage
index updates and revisions are implemented in a budget neutral manner.
Comment: One commenter expressed concern that hospices in
Montgomery County, Maryland are at a long-term competitive disadvantage
due to a Medicare hospice federal payment inequity involving core-based
statistical areas (CBSAs). The commenter suggested that the out
migration adjustment referenced in section 505 of the Medicare
Prescription Drug, Improvement and Modernization Act of 2003 be applied
to the hospice wage index. Section 505 introduced a hospital wage index
adjustment that is based on commuting patterns. One commenter stated
that CMS's and OMB's decision to view the current CBSA area designation
in the ``aggregate'' for a
[[Page 38501]]
large geographic region like NYC (making it a NY and New Jersey area)
fails to account for the higher costs faced by New York providers. The
commenter also disagreed with CMS's assertion that OMB's CBSA
designations are reasonable and appropriate, reflecting the most recent
available geographic classifications, and suggested wholesale revisions
and reform of the hospice and home health wage index to more accurately
reflect local market conditions.
Response: We further believe that using the most current OMB
delineations will increase the integrity of the hospice wage index by
creating a more accurate representation of geographic variation in wage
levels. We recognize that the OMB cautions that the delineations should
not be used to develop and implement federal, state, and local
nonstatistical programs and policies without full consideration of the
effects of using these delineations for such purposes. As discussed in
the OMB Bulletin No. 03-04 (June 6, 2003), the OMB stated that, ``In
cases where there is no statutory requirement and an agency elects to
use the Metropolitan, Micropolitan, or Combined Statistical Area
definitions in nonstatistical programs, it is the sponsoring agency's
responsibility to ensure that the definitions are appropriate for such
use. When an agency is publishing for comment a proposed regulation
that would use the definitions for a nonstatistical purpose, the agency
should seek public comment on the proposed use.'' \17\ While we
recognize that OMB's geographic area delineations are not designed
specifically for use in nonstatistical programs or for program
purposes, including the allocation of federal funds, we continue to
believe that the OMB's geographic area delineations represent a useful
proxy for differentiating between labor markets and that the geographic
area delineations are appropriate for use in determining Medicare
hospice payments. In implementing the use of CBSAs for hospice payment
purposes in our FY 2006 final rule (70 FR 45130), we considered the
effects of using these delineations. We have used CBSAs for determining
hospice payments for 13 years (since FY 2006). In addition, other
provider types, such as IPPS hospital, home health, SNF, IRF), and the
ESRD program, have used CBSAs to define their labor market areas for
the last decade.
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\17\ Bulletin 05-02, Update of Statistical Area Definitions and
Guidance on Their Uses. February 2005. https://www.whitehouse.gov/wp-content/uploads/2017/11/bulletins_fy05_b05-02.pdf.
---------------------------------------------------------------------------
Comment: MedPAC recommended that the Congress repeal the existing
hospital wage index and instead implement a market-level wage index for
use across other prospective payment systems, including certain post-
acute care providers. MedPAC suggested that their recommended wage
index would: Use wage data from all employers and industry-specific
occupational weights, adjust for geographic differences in the ratio of
benefits to wages, adjust at the county level and smooth large
differences between counties, and include a transition period to
mitigate large changes in wage index values. Several commenters
recommended that CMS should develop a wage index model in line with the
system recommended by MedPAC. One commenter questioned whether the
hospital wage index sufficiently takes into account the labor costs
associated with the extensive travel routinely required in the delivery
of hospice care. The commenter further asserted that the travel costs
are even higher on a per-patient per-day basis for hospices that serve
rural populations with large catchment areas, where patients may be
located in remote and geographically isolated areas. The commenter
suggested that CMS should analyze cost data to determine the extent to
which costs vary based on geographic setting and should incorporate
findings from its analysis into payment through appropriate payment
adjustments, in order to protect and promote access to hospice care for
rural beneficiaries with terminal illness.
Response: We appreciate MedPAC's recommendations; however, we do
not have the authority to repeal the existing hospital wage index
absent Congressional action. We note that our regulations at Sec.
418.306(c) require that each hospice's labor market is determined based
on definitions of Metropolitan Statistical Areas (MSAs) issued by OMB.
We will issue annually, in the Federal Register, a hospice wage index
based on the most current available CMS hospital wage data, including
changes to the definition of MSAs. The urban and rural area geographic
classifications are defined in Sec. 412.64(b)(1)(ii)(A) through (C).
The payment rates established by us are adjusted by the Medicare
contractor to reflect local differences in wages according to the
revised wage data. Any changes to the way we adjust hospice payments to
account for geographic wage differences would have to go through the
rulemaking with comment process. We note that in the proposed rule, we
did solicit requests for information to explore alternate ways to wage-
adjust payments. We will review all comments for any consideration in
future rulemaking.
To address the comment whether the hospital wage index sufficiently
takes into account the labor costs associated with, the extensive
travel routinely required in the delivery of hospice care, we note that
the hospital wage index reflects the area wages and does not factor in
any travel expenses. We recognize that hospices do incur travel
expenses and with the rebasing of the CHC, IRC, and GIP payment rates
finalized in this rule, such expenses were captured to more accurately
align payment with the cost of providing care.
Final Decision: After considering the comments received in response
to the proposed rule and for the reasons discussed above, we are
finalizing our proposal 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. For FY 2020, the updated wage
data are for hospital cost reporting periods beginning on or after
October 1, 2014 and before October 1, 2015 (FY 2015 cost report data).
The wage index applicable for FY 2020 is available on our website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Hospice-Wage-Index.html. The hospice wage index for FY 2020 will be
effective October 1, 2019 through September 30, 2020.
3. FY 2020 Hospice Payment Update Percentage
Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L.
105-33) amended section 1814(i)(1)(C)(ii)(VI) of the Act to establish
updates to hospice rates for FYs 1998 through 2002. Hospice rates were
to be updated by a factor equal to the inpatient hospital market basket
percentage increase set out under section 1886(b)(3)(B)(iii) of the
Act, minus 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.
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
[[Page 38502]]
the 10-year moving average of changes in annual economy-wide private
nonfarm business multifactor productivity (MFP).
The hospice payment update percentage for FY 2020 is based on the
estimated inpatient hospital market basket update of 3.0 percent (based
on IHS Global Inc.'s second-quarter 2019 forecast with historical data
through the first quarter 2019). Due to the requirements at sections
1886(b)(3)(B)(xi)(II) and 1814(i)(1)(C)(v) of the Act, the estimated
inpatient hospital market basket update for FY 2020 of 3.0 percent must
be reduced by a MFP adjustment as mandated by Affordable Care Act
(currently estimated to be 0.4 percentage point for FY 2020). In
effect, the hospice payment update percentage for FY 2020 is 2.6
percent.
Currently, the labor portion of the hospice payment rates is as
follows: For RHC, 68.71 percent; for CHC, 68.71 percent; for General
Inpatient Care, 64.01 percent; and for Respite Care, 54.13 percent. The
non-labor portion is equal to 100 percent minus the labor portion for
each level of care. Therefore, the non-labor portion of the payment
rates is as follows: For RHC, 31.29 percent; for CHC, 31.29 percent;
for General Inpatient Care, 35.99 percent; and for Respite Care, 45.87
percent. Beginning with cost reporting periods starting on or after
October 1, 2014, freestanding hospice providers are required to submit
cost data using CMS Form 1984-14 (https://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Cost-Reports/Hospice-2014.html). We continue to analyze this data for possible use
in updating the labor portion of the hospice payment rates. Any changes
to the labor portions would be proposed in future rulemaking and would
be subject to public comments.
While a majority of the comments received were about the rebasing
methodology and analysis, we did receive a few comments regarding the
hospice payment update percentage. Our responses to those comments are
below:
Comment: MedPAC recognizes that CMS is required by statute to
propose an increase to the FY 2020 base rates of 2.7 percent, however
they noted that in their 2019 report to Congress, they recommended that
Congress reduce the aggregate level of payment to hospices for FY 2020
by 2 percent.
Response: We appreciate the comment, however, we do not have the
statutory authority to use an alternate methodology to determine the
amount of the annual payment updates to hospice payment rates.
Comment: One commenter stated that for organizations that rely on
contractual arrangements to meet their inpatient care requirements, the
budget neutrality component that lowers the RHC payment rates
effectively turns the rebasing proposal into a rate cut even after the
proposed 2.7 percent payment update.
Response: We note that we are statutorily required, as set forth in
section 1814(i)(1)(C)(ii)(VII) of the Act, to update the hospice rates
annually by the inpatient market basket percentage increase for that
FY.
Final Decision: We are finalizing the hospice payment update
percentage for FY 2020 as proposed. Based on IHS Global, Inc.'s updated
forecast of the inpatient hospital market basket update and the
multifactor productivity adjustment, the hospice payment update
percentage for FY 2020 is equal to 2.6 percent for hospices that submit
the required quality data and 0.6 percent (FY 2020 hospice payment
update of 2.6 percent minus 2 percentage points) for hospices that do
not submit the required data.
4. FY 2020 Rebased Hospice Payment Rates
There are four hospice payment categories, all of which are
distinguished by the location and intensity of the 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 provided to treat symptoms that cannot be managed in another
setting.
As discussed in the FY 2016 Hospice Wage Index and Rate Update
final rule (80 FR 47172), we implemented two different RHC payment
rates, one RHC rate for the first 60 days and a second RHC rate for
days 61 and beyond. In addition, in that final rule, we implemented a
Service Intensity Add-on (SIA) payment for RHC when direct patient care
is provided by a 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 SIA budget neutrality factor.
As discussed in the FY 2016 Hospice Wage Index and Rate Update
final rule (80 FR 47177), we will continue to make the SIA payments
budget neutral through an annual determination of the SIA budget
neutrality factor (SBNF), which will then be applied to the RHC payment
rates. The SBNF will be calculated for each FY using the most current
and complete utilization data available at the time of rulemaking. For
FY 2020, this calculation reflects the proposed increase in the hourly
rate for CHC as a result of rebasing, discussed in section III.A.3 of
this final rule.
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. In order to calculate the
wage index standardization factor, we simulate total payments using the
proposed FY 2020 hospice wage index (no lag) and compare it to our
simulation of total payments using the FY 2019 hospice wage index. By
dividing payments for each level of care using the FY 2020 wage index
(no lag) by payments for each level of care using the FY 2019 wage
index, we obtain a wage index standardization factor for each level of
care (the first 60 RHC days and RHC days after day 60 and, CHC, IRC,
and GIP). The wage index standardization factors for each level of care
are shown in the Tables 10 and 12 below.
As discussed in section III.A.3, we are finalizing rebasing of the
per diem payment rates for CHC, IRC, and GIP levels of care. As
mentioned above and outlined in the Affordable Care Act, hospice
payment reform must be done in a budget-neutral manner. In order to
rebase the per diem payment amounts for CHC, IRC, and GIP in a budget-
neutral manner, as described in section III.A.3, increases to the CHC,
IRC, and GIP per diem payment amounts will be offset by corresponding
decreases to the RHC per diem payment amounts to maintain overall
budget neutrality.
The FY 2020 RHC per diem payment rates are the FY 2019 rebased
payment rates, reduced by a budget neutrality factor as a result of
rebasing of the CHC, IRC, and GIP payment amounts, adjusted by the SIA
budget neutrality factor, adjusted by the wage index standardization
factor, and increased by
[[Page 38503]]
the 2.6 percent hospice payment update percentage as shown in Table 10.
The FY 2020 rebased CHC, IRC, and GIP per diem payment rates are equal
to the FY 2019 rebased payment rates, adjusted by the wage index
standardization factor and increased by the hospice payment update
percentage (2.6 percent) as shown in Table 11.
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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 final rule (76 FR 47320
through 47324), we implemented a Hospice Quality Reporting Program as
required by section 3004 of the Affordable Care Act. Hospices were
required to begin collecting quality data in October 2012, and submit
that quality data in 2013. Section 1814(i)(5)(A)(i) of the Act requires
that beginning with FY 2014 and each subsequent FY, the Secretary shall
reduce the market basket update by 2 percentage points for any hospice
that does not comply with the quality data submission requirements with
respect to that FY. The FY 2020 rates for hospices that do not submit
the required quality data is updated by the FY 2020 hospice payment
update percentage of 2.6 percent minus 2 percentage points. These rates
are shown in Tables 12 and 13.
[[Page 38504]]
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[GRAPHIC] [TIFF OMITTED] TR06AU19.034
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[[Page 38505]]
Final Decision: We are finalizing the FY 2020 payment rates in
accordance with statutorily mandated requirements.
5. Hospice Cap Amount for FY 2020
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, 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. The hospice cap amount for the FY 2020 cap year will
be $29,964.78, which is equal to the FY 2019 cap amount ($29,205.44)
updated by the FY 2020 hospice payment update percentage of 2.6
percent. A summary of the comments we received regarding the hospice
cap amount and our responses to those comments appear below:
Comment: A few commenters suggested that geographical differences
should be considered when calculating the annual cap amounts. One
commenter stated that the cap discriminates against providers with
higher daily reimbursement rates because the cap is applied on a
national basis, without regard to the geographical location of the
patient. Another commenter suggested adjusting the hospice cap amounts
for wage index in the same manner that the per diem payments are
adjusted. This commenter further asserted that wage adjusting the
payments and not the cap has the effect of reversing the wage index,
since the caps will be reached (and exceeded) more quickly in high wage
labor markets than in low wage labor markets. The commenter suggested
that this creates an unintended penalty or benefit to a hospice based
on where it is located, not on the quality or efficiency of the care
provided.
Response: We appreciate the commenters' suggestion that we consider
geographical differences when calculating the annual cap amount.
However, the restriction set forth in section 1814(i)(2)(B) of the Act,
as amended by section 3(d) of the IMPACT Act, does not give us
discretion to adjust the cap amount.
Comment: One commenter recommended that funds allocated for the cap
amount increase instead be applied to reducing the cut to the RHC. The
commenter suggested that holding the cap at its current level would
also likely hold down margins from high-margin hospices. A few
commenters also suggested that lowering the aggregate cap amount for
all hospices by at least 10 percent from the FY 2019 amount would be a
better way to control hospice spending.
Response: We appreciate the commenter's suggestion that we lower
the annual cap amount. However, the restriction set forth in section
1814(i)(2)(B) of the Act, as amended by section 3(d) of the IMPACT Act,
does not give us discretion to adjust the cap amount.
Comment: One commenter suggested the cap amount be used to explore
questionable practices by hospices. Specifically, this commenter was
referring to hospices that come up to the cap limit, but do not exceed
it, because they are deliberately discharging beneficiaries solely to
avoid any overpayments. This commenter also stated that CMS should
further investigate those hospices that routinely exceed the cap limit
to see if there is any aberrant patterns of care that may warrant
targeted program integrity efforts. The commenter stated that CMS could
use its program integrity authority using claims and quality data to
address this issue with little additional burden to hospice agencies.
Response: We appreciate the commenter's suggestion to consider
looking into the practices of hospices that regularly reach or exceed
the annual aggregate cap amount to target further program integrity
investigations. We remind stakeholders that under the Medicare hospice
benefit, Sec. 418.26(a)(1), (2), and (3), there are limited reasons
why a hospice can discharge a beneficiary alive: The beneficiary
decides to revoke the hospice benefit; the beneficiary transfers to
another hospice; or, the beneficiary is no longer terminally ill.
Hospice care is provided to beneficiaries who are nearing the end of
life and provides comfort for the dying, neither hastening death nor
prolonging life by attempting to cure the terminal illness. Discharging
a beneficiary solely to avoid exceeding the cap limit is in violation
of the regulations at Sec. 418.26 and may cause undue distress and
potential harm to terminally ill patients who would have to seek care
outside of the hospice benefit. We will closely monitor this issue and
address any identified concerns, if necessary.
Final Decision: We are finalizing the update to the hospice cap in
accordance with statutorily mandated requirements.
C. Election Statement Content Modifications and Addendum To Provide
Greater Coverage Transparency and Safeguard Patient Rights
1. Background
In the FY 2020 hospice proposed rule (84 FR 17589), we provided
background on the holistic nature of the services provided under the
Medicare hospice benefit, as well as the current statutory and
regulatory requirements for care planning and patient rights. We stated
that in order to make an informed choice about whether to receive
hospice care, the patient, family, and caregiver must have an
understanding of what services are going to be provided by the hospice
and that, because there is no longer a reasonable expectation for a
cure, care should now focus on comfort and quality of life. The
services covered under the Medicare hospice benefit are comprehensive
such that, upon election, the individual waives all rights to Medicare
payment for services related to the treatment of the individual's
condition with respect to which a diagnosis of terminal illness has
been made, except when provided by the designated hospice or attending
physician. Because of the significance of this decision, the terminally
ill individual must elect hospice care in order to receive services
under the Medicare hospice benefit. Since we first implemented the
Medicare hospice benefit in 1983, it has been our general view that the
waiver required by law requires hospices to provide virtually all the
care that is needed by terminally ill patients (48 FR 56010).
Additionally, in the FY 2015 proposed rule (79 FR 26555), we
described the eligibility, certification, and election requirements for
receipt of hospice services as set forth at 42 CFR 418.20, 418.22 and
418.24. We also emphasized that in reaching a decision to certify that
the patient is terminally ill, the hospice medical director must
consider the principal diagnosis of the patient, all other health
conditions, whether related or unrelated to the terminal condition, and
all clinically relevant information supporting all diagnoses. The
clinical information and other documentation that support the medical
prognosis must accompany the written certification and must be filed in
the individuals' hospice medical record in accordance with the
regulations at Sec. 418.22(b)(2) and the hospice CoPs at Sec.
418.102(b). Once a beneficiary is certified as terminally ill, he or
she becomes eligible to elect hospice care under the Medicare hospice
benefit.
Because the receipt of hospice services under the Medicare hospice
[[Page 38506]]
benefit is dependent upon the eligible beneficiary electing to receive
hospice care, the regulations at Sec. 418.24 provide the requirements
of the hospice election statement. The election statement must include
the identification of the designated hospice and attending physician
(if any); the individual's or representative's acknowledgement that he
or she has been given a full understanding of the palliative rather
than curative nature of hospice care; and the individual's or
representative's acknowledgement that the individual waives the right
to Medicare payment for services related to the terminal illness and
related conditions, except when provided by the designated hospice or
attending physician. Services unrelated to the terminal illness and
related conditions remain eligible for Medicare coverage and payment
outside of the hospice benefit.
Once the beneficiary has elected hospice care, the hospice conducts
an initial assessment visit in advance of furnishing care. During this
visit, the hospice must provide the patient or representative with a
spoken and written notice of the patient's rights and responsibilities
as required by the CoPs at Sec. 418.52. Our rules state that the
beneficiary has the right to be involved in developing his or her
hospice plan of care; receive information about the services covered
under the hospice benefit; and receive information about the scope of
services that the hospice will provide and specific limitations on
those services. The hospice program must assure the patient that its
staff will protect patients' rights and will involve patients in
decisions about their care, treatment and services.\18\ Likewise, the
regulations at Sec. 476.78(b)(3) state that providers must inform
Medicare beneficiaries at the time of admission, in writing, that the
care for which Medicare payment is sought will be subject to Quality
Improvement Organization (QIO) review.
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\18\ State Operations Manual Appendix M--Guidance to Surveyors:
Hospice. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_m_hospice.pdf.
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Additionally, the hospice CoPs at Sec. 418.54(c) provide the
content requirements for the initial and comprehensive assessments used
to identify patient, family, and caregiver needs for physical,
emotional, psychosocial, and spiritual care. As part of the
comprehensive assessment, the hospice is required to assess the patient
for complications and risk factors, which can affect care planning. The
needs identified in these assessments drive the development and
revisions of an individualized written plan of care for each patient as
required by the CoPs at Sec. 418.56. Collectively, the
interdisciplinary team (IDG), in consultation with the patient's
attending physician (if any), makes care plan decisions for each
patient to ensure that each care plan is individualized to meet the
unique needs of each hospice beneficiary. The plan of care also must
reflect patient, family, and caregiver preferences, goals, and
interventions based on the problems identified in the initial,
comprehensive, and updated comprehensive assessments. The plan of care
must include all services necessary for the palliation and management
of the terminal illness and related conditions and the CoPs at Sec.
418.56(c) detail the plan of care content requirements. However, though
hospices are responsible for providing all services needed for
palliation and management of the terminal illness and related
conditions, the 2008 Hospice Conditions of Participation final rule (73
FR 32088, June 5, 2008) states that while needs unrelated to the
terminal illness and related conditions are not the responsibility of
the hospice, the hospice may choose to furnish services for those needs
regardless of responsibility (73 FR 32114). If a hospice does not
choose to furnish services for those needs unrelated to the terminal
illness and related conditions, the hospice is to document such needs
and communicate and coordinate with those health care providers who are
identified as caring for the unrelated needs, as set out at Sec.
418.56(e)(5). To ensure comprehensive and coordinated care, at Sec.
418.56(e) we require hospices to have a communication system that
allows for the exchange of information with other non-hospice health
care providers who are furnishing care unrelated to the terminal
illness and related conditions.
We also require hospices to designate a registered nurse (RN) who
is a member of the IDG to coordinate implementation of the
comprehensive plan of care. The designated RN must assure that
coordination of care and continuous assessment of patient, family, and
caregiver needs occur among staff providing services to the patient,
family, and caregiver so that all IDG members are kept informed of the
patient/family's status.\19\ The goal of a coordinated communication
process and a designated nurse coordinator is to adequately ensure that
each patient's hospice care is coordinated both within the hospice and
with other health care providers.
---------------------------------------------------------------------------
\19\ State Operations Manual Appendix M--Guidance to Surveyors:
Hospice. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_m_hospice.pdf.
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2. Services Unrelated to the Terminal Illness and Related Conditions
In the FY 2020 hospice proposed rule, we reiterated our long-
standing position that services unrelated to the terminal illness and
related conditions should be exceptional, unusual and rare given the
comprehensive nature of the services covered under the Medicare hospice
benefit as articulated upon the implementation of the benefit (48 FR
56008, 56010, December 16, 1983). To the extent that individuals
receive services outside of the Medicare hospice benefit during a
hospice election, Medicare coverage is determined by whether or not the
services are for the treatment of a condition completely unrelated to
the individual's terminal illness and related conditions (48 FR 38146,
38148, August 22, 1983). In the FY 2020 hospice proposed rule, we
detailed numerous anecdotal reports from beneficiaries, families, the
Medicare Ombudsman's office, and non-hospice providers where hospice
patients were obtaining needed items, services, and drugs outside of
the hospice benefit because they had been told that hospice would not
cover these items, services, and drugs, as the hospice had determined
that they were unrelated to the terminal illness and related
conditions. Many of these anecdotal reports state that the
beneficiaries and families believed that these items, services, and
drugs were related to the terminal illness and related conditions and
thought that they should have been provided by the hospice. The
beneficiaries and/or the families stated that they did not know they
would have to seek care outside of the hospice benefit for these
conditions because the hospice did not tell them these items, services,
and drugs would not be furnished by the hospice until the patient
needed them. We remind stakeholders that the Medicare Beneficiary
Ombudsman (MBO) is charged with supporting CMS' customer service and
administration efforts by receiving and responding to beneficiary and
other stakeholder inquiries and complaints, working with partners to
provide outreach and education to beneficiaries, and providing
recommendations for improving the administration of Medicare. The MBO
also provides an annual report to
[[Page 38507]]
Congress that are posted on the MBO website.\20\
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\20\ Medicare Beneficiary Ombudsman (MBO). https://www.cms.gov/Center/Special-Topic/Ombudsman/Medicare-Beneficiary-Ombudsman-Home.html.
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In accordance with the hospice CoPs at Sec. 418.56(e)(5), and in
alignment with continuity of care principles,\21\ the ongoing sharing
of information with other non-hospice healthcare providers and
suppliers furnishing services unrelated to the terminal illness and
related conditions is necessary to ensure coordination of services and
to meet the patient, family, and caregiver needs. The coordination
requirements include that the hospice must develop and maintain a
system of communication and integration amongst all providers
furnishing care to the terminally ill patient. This communication helps
to minimize fragmented care and to improve quality of life. Part of
that communication process is the clear identification of what the
related and unrelated conditions are and who is responsible for
providing reasonable and necessary services for those conditions. As is
the preferred practice for care coordination and communication,\22\
both hospice and non-hospice providers typically document these
discussions, which then becomes part of the patient's medical record
with each provider. Accordingly, all Medicare providers and suppliers
must be able to provide medical documentation to support payment for
services billed (sections 1815(a) and 1833(e) of the Act). For non-
hospice providers or suppliers billing Medicare for services received
by hospice beneficiaries unrelated to their terminal illness and
related conditions, this includes being able to provide documentation
from the hospice listing the conditions (and thus items, drugs, and
services) the hospice determined to be unrelated and documented as such
on the hospice plan of care.
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\21\ Uijena,A., Schersa,H., Schellevisb, F., van den Bosch,W.
How unique is continuity of care? A review of continuity and related
concepts. Family Practice 2012; 29:264-271 doi:10.1093/fampra/
cmr104.
\22\ National Quality Forum (NQF), Preferred Practices and
Performance Measures for Measuring and Reporting Care Coordination:
A Consensus Report, Washington, DC: NQF; 2010. https://www.qualityforum.org/Publications/2010/10/Preferred_Practices_and_Performance_Measures_for_Measuring_and_Reporting_Care_Coordination.aspx.
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While hospices are required by the CoPs to have a system of
communication with non-hospice providers to furnish such information,
we have heard anecdotally from non-hospice providers stating that they
are unable to reach or do not receive return calls from the hospice to
discuss the hospice beneficiary's coordination of services that the
hospice has determined unrelated to his or her terminal illness and
related condition(s). Likewise, we have also received anecdotal reports
from hospices who state they were unaware that patients had received
care from non-hospice providers. In these reports, the hospice would
first learn of this outside care when non-hospice providers would
contact the hospice seeking reimbursement. If this care was related to
the terminal illness and related conditions and the hospice did not
make arrangements for such care, the beneficiary would be liable for
the costs of receiving that care. Additionally, if non-hospice
providers bill Medicare for services that potentially should have been
the coverage responsibility of hospice, Medicare could be making
duplicative payments for care related to the terminal illness and
related conditions, as described in the June, 2012 OIG report \23\
identifying situations where Medicare may have been paying twice for
prescription drugs for hospice beneficiaries.
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\23\ Medicare Could Be Paying Twice for Prescription Drugs for
Beneficiaries in Hospice (A-06-10-00059). June 28, 2012. https://oig.hhs.gov/oas/reports/region6/61000059.pdf.
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In previous years' hospice proposed rules, we have included data on
non-hospice expenditures for beneficiaries under a hospice election.
These total non-hospice expenditures include beneficiary cost-sharing
amounts. For Parts A and B, the beneficiary cost-sharing amounts in FY
2017 totaled approximately $138 million and for Part D, the beneficiary
cost-sharing totaled approximately $68.6 million (83 FR 20946 through
20947). We believe that this is a substantial financial burden being
placed on terminally ill individuals for services that potentially
should have been covered by hospice. This suggests that hospice
beneficiaries may be incurring unnecessary financial burden as they are
having to seek out and pay for items and services for pain and symptom
relief--services that hospice should be furnishing and covering.
However, in spite of the data provided and reiteration of
longstanding policy regarding the comprehensive nature of hospice
services covered under Medicare, we continue to have concerns that
these decisions as to what hospices will cover and not cover are based
on a more narrow view of the overall condition of the individual, as is
evidenced by the non-trivial amount of items, services, and drugs for
potentially related conditions provided by non-hospice providers to
beneficiaries under a hospice election.
3. Election Statement Content Modifications and Addendum To Provide
Greater Coverage Transparency and Safeguard Patient Rights
The regulations, as described previously, require the hospice to
include all services needed for the palliation and management of the
terminal illness and related conditions on the individualized hospice
plan of care, and the plan of care should also identify the conditions
or symptoms that the hospice determines to be ``unrelated'' so hospices
can provide ongoing sharing of information with other non-hospice
healthcare providers who may be furnishing services unrelated to the
terminal illness and related conditions.\24\ Although hospices are
required to educate each patient and the primary caregiver(s) on the
services identified on the plan of care and document the patient's or
representative's level of understanding, involvement, and agreement
with the plan of care, the incidence of anecdotal reports and the
amount and nature of the non-hospice services being billed to Medicare
outside of the hospice benefit suggests that hospice beneficiaries may
not be fully informed, at the time of admission or throughout the
hospice election, of the items, services, and drugs the hospice has
determined to be unrelated to their terminal illness and related
conditions. We believe this is necessary information for patients and
their families to make informed care decisions and to anticipate any
financial liability associated with needed items, services, and drugs
not provided under the Medicare hospice benefit. Not having this
information may result in a lack of coverage transparency and where
beneficiaries are unaware of their financial liability while under a
hospice election for those items, services, and drugs the hospice has
determined to be unrelated to their terminal prognosis.
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\24\ State Operations Manual Appendix M--Guidance to Surveyors:
Hospice https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_m_hospice.pdf. (L-Tag 538)
---------------------------------------------------------------------------
Therefore, in the FY 2020 hospice proposed rule (84 FR 17570), we
proposed to modify the hospice election statement content requirements
at Sec. 418.24(b) to increase coverage transparency for patients under
a hospice election. In addition to the existing election statement
content requirements at Sec. 418.24(b), we proposed that hospices also
would be
[[Page 38508]]
required to include the following on the election statement:
Information about the holistic, comprehensive nature of
the Medicare hospice benefit.
A statement that, although it would be rare, there could
be some necessary items, drugs, or services that will not be covered by
the hospice because the hospice has determined that these items, drugs,
or services are to treat a condition that is unrelated to the terminal
illness and related conditions.
Information about beneficiary cost-sharing for hospice
services.
Notification of the beneficiary's (or representative's)
right to request an election statement addendum that includes a written
list and a rationale for the conditions, items, drugs, or services that
the hospice has determined to be unrelated to the terminal illness and
related conditions and that immediate advocacy is available through the
BFCC-QIO if the beneficiary (or representative) disagrees with the
hospice's determination.
Likewise, we proposed to make the corresponding regulations text
changes at Sec. 418.24(b).
Additionally, we proposed a new requirement where hospices would be
required, but only upon request, to provide to the beneficiary (or
representative) an election statement addendum (hereafter called ``the
addendum'') with a list and rationale for the conditions items,
services, and drugs that the hospice has determined as unrelated to the
terminal illness and related conditions. Similarly, we proposed that
hospices would be required to provide the addendum, upon request, to
other non-hospice providers that are treating such conditions, and
Medicare contractors who request such information. We proposed that if
the addendum is requested at the time of hospice election, the hospice
must provide this information, in writing, to the individual (or
representative) within 48 hours of the request. Furthermore, we
proposed that if this addendum is requested during the course of
hospice care, the hospice must provide this information, in writing,
immediately to the requesting individual (or representative), non-
hospice provider, or Medicare contractor, as this information should be
readily available in the beneficiary's hospice medical record. During
the course of hospice care, if there are changes to the plan of care
that result in a determination that a new illness or condition has
arisen, we proposed that hospices would be required to issue an updated
addendum to the patient (or representative) reflecting whether or not
items, services and supplies related to the new illness or condition
will be provided by the hospice. We also proposed that hospices would
be exempt from completing this addendum if the beneficiary died within
48 hours of the election date of hospice care.
The purpose of the proposed addendum is to inform beneficiaries and
their families of hospice-determined non-covered conditions, items,
services, and drugs to provide full coverage transparency to hospice
patients and their families to assist in making treatment decisions.
Likewise, the addendum would help facilitate communication and benefit
coordination between hospices and non-hospice providers.
We proposed that hospices would develop and design the addendum to
meet their needs, similar to how hospices develop their own hospice
election statement. We proposed the addendum would be titled ``Patient
Notification of Hospice Non-Covered Items, Services, and Drugs.'' We
proposed that the addendum would include the following information:
1. Name of the hospice;
2. Beneficiary's name and hospice medical record identifier;
3. Identification of the beneficiary's terminal illness and related
conditions;
4. 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;
5. 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 would be accompanied by a
general statement that the decision as to whether or not conditions,
items, services, and drugs is related is made for each patient and that
the beneficiary should share this clinical explanation with other
health care providers from which they seek services unrelated to their
terminal illness and related conditions;
6. References to any relevant clinical practice, policy, or
coverage guidelines.
7. Information on the following domains:
a. Purpose of Addendum.
b. Right to Immediate Advocacy.
8. Name and signature of 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.
We proposed to add the election statement modifications and the
election statement addendum content requirements to the regulations at
Sec. 418.24.
Finally, we proposed that the signed addendum (and any signed
updates) would be a new condition for payment. We also stated that this
would not mean that in order to meet this condition for payment that
the beneficiary (or representative), or non-hospice provider must agree
with the hospice's determination. For purposes of this condition for
payment, we proposed that the signed addendum is only acknowledgement
of the beneficiary's (or representative's) receipt of the addendum (or
its updates) and this payment requirement would be met if there was a
signed addendum (and any signed updates) in the requesting
beneficiary's medical record with the hospice. This addendum would not
be required to be submitted with any hospice claims. Likewise, the
hospice beneficiary (or representative) would not have to separately
consent to the release of this information to non-hospice providers
furnishing services for unrelated conditions as the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) Privacy Rule allows
those doctors, nurses, hospitals, laboratory technicians, and other
health care providers that are covered entities to use or disclose
protected health information, such as X-rays, laboratory and pathology
reports, diagnoses, and other medical information for treatment
purposes without the patient's express authorization. This includes
sharing the information to consult with other providers, including
providers who are not covered entities, to treat a different patient,
or to refer the patient (45 CFR 164.506).
Ninety-two unique stakeholders submitted their comments on the
proposed modifications to the election statement content requirements
and the proposed election statement addendum. These stakeholders
included hospices, national and state industry associations, individual
commenters, as well as the Medicare Payment Advisory Commission
(MedPAC).
[[Page 38509]]
Election Statement Modifications
While many commenters supported the modifications to the election
statement content requirements, several had concerns regarding these
changes. These comments, along with our responses, are summarized
below.
Comment: Several commenters, including MedPAC, supported the
proposal to modify the hospice election statement content requirements
to increase coverage transparency for patients under a hospice
election. Commenters agreed with CMS' efforts to educate and empower
patients to make informed decisions. They reiterated the importance of
beneficiaries and their families understanding what is covered by the
hospice benefit and being informed of the resources available to appeal
decisions by hospice providers if they have concerns or disagree with
coverage determinations made by their hospice provider.
Response: We appreciate these comments and thank commenters for
their thoughtful review and support of our efforts to provide patients
with complete information regarding payment and cost-sharing
obligations as well as implications for other providers.
Comment: One commenter disagreed with the proposal that the
election statement include information on individual cost-sharing for
hospice services. This commenter stated that hospices are permitted,
but not required, to impose small coinsurance payments for hospice
drugs and inpatient respite care, and that most hospices do not charge
patients for this coinsurance. This commenter remarked that including
this information on the election statement would be confusing for
patients and burdensome for hospices to have to explain. Other
commenters suggested that additional language should be added to the
election statement to indicate that Medicare continues to pay for any
such unrelated items under traditional Medicare benefits.
Response: To provide full transparency regarding hospice coverage
under the Medicare hospice benefit, we believe that the election
statement should include information that there may be individual cost-
sharing for certain hospice services while under a hospice election. We
did not propose specific language requirements for communicating
information on cost-sharing for hospice services and we believe this
information can be communicated simply and in a straightforward fashion
to beneficiaries. For example, a general statement saying that while
under a hospice election there may be cost-sharing for hospice
medications and inpatient respite allows beneficiaries to ask the
hospice for more information on such cost-sharing, if needed. Likewise,
if a hospice does not charge any coinsurance for hospice drugs of
inpatient respite care, it could include such a statement on their
election statements.
As for the suggestion that CMS should require hospices to indicate
that there is coverage for unrelated items, services, and drugs on the
election statement itself, hospices can add whatever language they feel
best communicates information to the beneficiary about coverage under
the Medicare hospice benefit as long as such information is in
accordance with the hospice regulations. This could include a
disclaimer statement that unrelated items, services, and drugs may be
covered through other Medicare benefits. We note that in 2016, we
provided a model election statement as part of a MLN Matters[supreg]
article (SE1631) \25\ in which there is a statement that reads: ``I
understand that services not related to my terminal illness or related
conditions will continue to be eligible for coverage by Medicare.''
Hospices could adopt such language on the election statement to best
meet their needs and to adequately communicate this information to
beneficiaries and their families at the time of hospice election. One
industry commenter stated that many hospices already use this model
election statement and simple modifications to this election statement
could be easily achieved to satisfy the proposed changes to the
election statement content requirements.
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\25\ Sample Hospice Election Statement. MLN Matters[supreg]
Number: SE1631 Revised. December 2016. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1631.pdf.
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Election Statement Addendum
Comment: Several commenters stated that the time of hospice
election is an overwhelming and confusing time for individuals and
their families. Commenters remarked that the addendum might have the
unintended consequence of further overwhelming and frightening patients
and their families, giving the impression that patients would not be
given the symptom-controlling medications that they need. Some
commenters believe that the addendum may delay access to needed
services because of the time it would take to make these determinations
and consult with the IDG and could potentially deter individuals from
electing the benefit.
Response: The services covered under the Medicare hospice benefit
are comprehensive such that, upon election, the individual waives all
rights to Medicare payment for services related to the treatment of the
individual's condition with respect to which a diagnosis of terminal
illness has been made, except when provided by the designated hospice
or attending physician. Since we first implemented the Medicare hospice
benefit in 1983, it has been our general view that the waiver required
by law requires hospices to provide virtually all the care that is
needed for terminally ill patients (48 FR 56010). As such, we
understand that the decision to elect hospice is not one that is taken
lightly and it is because of the significance of this decision that we
believe individuals and their families need to have full disclosure and
coverage transparency regarding the services provided and not provided
by the hospice as they approach the end of life.
The hospice CoPs at Sec. 418.52(a) require that during the initial
assessment visit, in advance of furnishing care, the hospice must
provide the patient or representative with verbal (meaning spoken) and
written notice of the patient's rights and responsibilities in a
language and manner that the patient understands. Furthermore, hospices
are to inform the beneficiary of the services covered under the
Medicare hospice benefit, as well as the scope of such services. The
intent of this standard was to ensure that patients were aware of their
potential out-of-pocket costs for hospice care, such as co-payments, so
that they would not be surprised by financial concerns at this
stressful time (73 FR 32097). Therefore, hospices are already tasked
with providing detailed information on hospice services and limitations
to those services to the patient upon election of the benefit. We
believe that the addendum further complements these requirements by
ensuring that the hospice informs them of any items, services, or drugs
which the terminally ill individual would have to seek outside of the
benefit.
Because of the longstanding requirements to communicate the breadth
of the Medicare hospice benefit to individuals and their families prior
to the provision of any hospice services, we do not believe that
providing full coverage transparency at the time of hospice election
would generally deter or unnecessarily overwhelm individuals from
electing hospice, thereby limiting access to such services. Terminally
ill
[[Page 38510]]
individuals and their families are making decisions for how the
individual chooses to live out their remaining days at the end of life.
As the hospice model of care is for palliation and comfort, rather
than for a cure, the Medicare hospice benefit must be elected by the
terminally ill individual who is agreeing to this model of care, as
well as waiving the right to Medicare payment for items, services and
drugs for the treatment of the terminal illness and related conditions.
The purpose of the addendum as noted in the proposed and this final
rule is to provide for coverage transparency to help ensure individuals
are fully informed when making such a decision. If, after receiving
information about all of the items, services, and drugs the hospice
will and will not cover, the individual chooses not to elect the
benefit (or to discontinue the benefit), then the individual has made
an informed choice based on his or her goals and preferences of care.
Hospices should be able to communicate this information in a clear,
thoughtful, and compassionate manner in accordance with the spirit of
hospice philosophy where the individual and the family are the center
of the care team. In doing so, the hospice will have made every effort
to ensure patients are aware of all services covered and not covered by
the hospice. We believe that an informed beneficiary will make the most
appropriate choice to meet his or her needs and it is the hospice's
responsibility to provide this information to support and promote
beneficiary choice and access to needed services.
Comment: A few commenters disagreed with providing a written
clinical reason for why certain diagnoses/conditions, items, services,
and drugs are not covered to beneficiaries (or their representatives)
and non-hospice providers. These commenters stated that hospices may be
inconsistent with using evidence-based rationale or may use different
sources to support their determinations. Others voiced concerns over
disagreements between non-hospice providers and hospice providers on
the unrelated determinations and stated this may result in debate
regarding the hospice physician's reasoning. Commenters stated that
varying clinical opinions between hospice and non-hospice providers may
delay the provision of items, services, and drugs.
Response: We believe it is not only important to inform
beneficiaries of what items, services, and drugs the hospice will not
be covering because they have determined these items, services, and
drugs to be unrelated to the terminal illness and related conditions,
but why the hospice has made this determination. As noted previously,
beneficiaries are making a choice to elect hospice care and we believe
it to be of utmost importance to promote transparency, autonomy, and
patient choice, and patients need to understand the rationale for
decisions being made that affect their care. While we proposed that
hospices would provide a clinical rationale as part of the proposed
addendum, we did not propose requirements as to specific sources of
such information as we believe that hospices would use evidence-based
information to communicate the rationale to patients in a manner in
which they understand. There is a large quantity of available
information and hospices can choose to use supporting materials to best
communicate the clinical rationale to their patients. We do not expect
that this would mean hospices would have to provide complex or
technical supporting information to patients to rationalize their
determinations. However, similar to hospices explaining what items,
services, and drugs are related to the palliation and management of the
terminal illness and related conditions, we also believe that they have
the expertise to explain to patients why certain items, services and
drugs are not related. Furthermore, while there may be debate between
hospices and non-hospice providers regarding whether or not certain
items, services, or drugs are unrelated, we believe that the addendum
provides a tool to steer the debate and prompt meaningful communication
and care coordination between all providers rendering care to
terminally ill beneficiaries.
We agree with the hospice industry's views that hospice care is
``the nation's first coordinated care model'' and should show how the
health care system can work at its best for patients at the end of
life.\26\ We think that an important part of this care coordination is
communication with non-hospice providers who are also providing care to
the patient, in order to ensure that continuity of care and access to
needed services is part of the decision-making process and we do not
anticipate any delay in the furnishing of items, services, and drugs
due to the provision of this information to the patient. Similarly, the
hospice CoPs at 418.56(e)(5) require that hospices provide for an
ongoing sharing of information with other non-hospice healthcare
providers furnishing services unrelated to the terminal illness and
related conditions.
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\26\ NHPCO Op-ed: ``Coordinated Care Is More Than a Buzzword for
Hospice Providers'', April 24, 2018. https://morningconsult.com/opinions/coordinated-care-more-than-buzzword-for-hospice-providers/
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Comment: Overall, while commenters did not disagree in general with
the proposal of the election statement addendum, the majority of
commenters stated concern with the proposed timeframe with which the
hospice would be required to provide the patient and caregiver such
information. Commenters indicated that 48 hours after the time of
hospice election is insufficient considering that the hospice has 5
days to complete the comprehensive assessment. Commenters noted that
prior to the comprehensive assessment, hospices may not have a complete
patient profile, including the services or medications a patient is
currently utilizing. These commenters stated that this may require
hospices to anticipate covered and non-covered services, which would
lead to an inaccurate election statement addendum. Commenters stated
that this fails to provide patients with the information the election
statement addendum is intended to convey. A few commenters stated that
the 48 hour timeframe would not allow adequate time to consult with the
patient's certifying physician and/or the medical director regarding
medications and treatments, or to provide a written clinical
explanation of why the medications or services are unrelated. Other
commenters noted that nurses may be required to complete and print the
election statement addendum in the patient's home, where clinical
practice and policy guidelines may not be readily accessible, and would
necessitate the hospice providing nurses with printers. Similarly,
commenters stated that this timeframe may pose problems meeting
signature requirements if the patient or representative does not return
the signed election statement addendum within the required timeframe.
Another commenter suggested that this may require a costly electronic
solution or modifications to the existing electronic medical record
(EMR).
Response: We understand the concern regarding the proposed 48 hour
timeframe for providing the addendum if requested at the time of a
hospice election. We recognize that in order to provide the patient or
representative with the most accurate information, and ensure the
usefulness of the proposed addendum, it would be beneficial to align
the timeframe of the completion of
[[Page 38511]]
the addendum with the timeframe requirement of the completion of the
comprehensive assessment, that is, if an addendum is requested at the
time of a hospice election, the hospice would have 5 calendar days to
provide the addendum to the requesting beneficiary (or representative).
This would allow hospices sufficient time to assess all of the patient
and family needs, establish the individualized plan of care, and make
decisions about any items, services, or drugs they will not be
covering, as they have determined them to be unrelated to the terminal
illness and related conditions. Furthermore, if a beneficiary requests
the addendum at the time of hospice election and dies within 5 days
from the start of the hospice election, the hospice would not be
required to furnish such addendum as this requirement would be deemed
as being met in this circumstance.
We also understand that if the beneficiary, representative, non-
hospice provider, or Medicare contractor requests an addendum at any
time during the course of hospice care (that is, after the election of
hospice), the hospice would need sufficient time for the IDG to
adequately review the patient's plan of care and review any decisions
on those items, services, or drugs they have determined to be unrelated
to the individual's terminal illness and related conditions. As such,
we believe that the hospice should have additional time to complete the
addendum, rather than the proposal to require the hospice to provide it
immediately upon request during the course of hospice care. Because the
hospice has already completed the comprehensive assessment and has
begun providing care, we believe 72 hours after a patient,
representative, non-hospice provider or Medicare contractor request for
such information represents a sufficient timeframe for reviewing the
patient record and completing the addendum if this information is
requested during the course of hospice care. As the plan of care should
identify the conditions or symptoms that the hospice determines to be
``unrelated,'' this information should be readily accessible to the
hospice in order to allow for the timely completion of the addendum.
Expanding the timeframe for completion would ensure that the hospice
has adequate time to determine those items, services, and drugs that
are unrelated, complete the written addendum, and provide this
information to the patient (or his or her representative).
As detailed in the FY 2020 hospice proposed rule, we proposed that
each individual hospice develop and incorporate the addendum into their
current admissions process in a way that best meets the hospices'
needs, as well as providing this information as quickly as possible
considering the potential for beneficiary cost-sharing. Likewise, non-
hospice providers should have timely access to this information in
order to promote continuity of care and communication amongst all
patient providers and to ensure appropriate claims submission.
Comment: Many commenters suggested modifying the current Advance
Beneficiary Notice of Non-coverage (ABN) (Form CMS-R-131) or the Home
Health Change of Care Notice (HHCCN) (Form CMS-10280) to be hospice-
specific to communicate unrelated information regarding items,
services, and drugs, rather than requiring hospices to develop a new
form. One industry association suggested a ``Hospice Change of Care
Notice'' be developed and provided to patients and representatives upon
request to meet the requirements for communication about items and
services determined to be unrelated to the terminal prognosis. This
commenter suggested providing this form after the initial and
comprehensive assessment has been completed, the plan of care has been
established, and members of the IDG have agreed upon the unrelated
items and services.
Others suggested offering patients (and their representatives),
upon request, a list of known diagnoses unrelated to the terminal
illness and related conditions with the recommendation that this list
could be updated through the course of care if any new unrelated
diagnoses/conditions became known. These commenters stated that this
would improve transparency and hold hospices more accountable for
documenting and communicating these unrelated diagnoses to the patient
and representative. A few commenters suggested the need for a patient/
representative statement acknowledging that the patient or patient
representative has reviewed the items, services, and medications with
the hospice representative in order to protect the hospice from
inadvertently excluding any medications or treatments the patient is
receiving at the time of admission, but that may not be revealed.
Commenters also suggested that the patient be required to acknowledge
that a new election statement addendum would be signed if additional
non-covered items, services, or medications were identified during the
course of treatment.
Additionally, commenters noted that the addendum should address
items, services and drugs that may be related, but that the hospice is
not covering, for example a generic drug over a brand name drug due to
patient preference or if a patient requests to continue using a
specific drug that the hospice determines is no longer providing
medical benefit to the patient. A few commenters recommended using the
Medicare form, Hospice Information for Medicare Part D (OMB Form 0938-
1269) stating that most hospices already use this form and that
requiring a separate addendum is redundant and not necessary.
Conversely, a few commenters stated that the aforementioned Part D form
is fraught with issues and there is inconsistency with its use amongst
hospices and Part D plan sponsors. A few commenters stated that this
proposal is unreasonable because no other healthcare provider is
required to furnish references for any decision that the provider makes
regarding services not provided nor requires a patient to sign a
detailed document listing what will not be provided.
Response: We agree with commenters that the list of items,
services, and drugs not covered by the hospice because they have
determined them to be unrelated to the terminal illness and related
conditions should be in a format that communicates this information to
patients and their representatives in the most clear and unobtrusive
way possible. As stated earlier, we believe that hospices should
develop this addendum, with the required content elements, to best meet
their patients' needs and to align with their current admission
processes and other business procedures. We disagree with commenters
about using a modified ABN to communicate information about hospice
non-covered items, services and drugs determined to be unrelated to the
terminal illness and related conditions. The ABN, Form CMS-R-131, is
issued by providers (including independent laboratories, home health
agencies, and hospices), physicians, practitioners, and suppliers to
Original Medicare (fee for service--FFS) beneficiaries in situations
where Medicare payment is expected to be denied. The ABN is issued in
order to transfer potential financial liability to the Medicare
beneficiary in certain instances. Guidelines for issuing the ABN are
published in the Medicare Claims Processing Manual, Chapter 30, Section
50.\27\ As such, the purpose of
[[Page 38512]]
the ABN is to inform beneficiaries of the listed items and services
that Medicare is not expected to approve, and the specific denial
reason (that is, not medically reasonable and necessary), whereas, the
proposed hospice addendum is intended to inform beneficiaries of items
and services that the hospice will not cover as the hospice has
determined them to be unrelated to the terminal illness and related
conditions, and therefore, subject to coverage under other Medicare
benefits. Similarly, mandatory use of the ABN is very limited for
hospices. The three situations that would require issuance of the ABN
by a hospice are:
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\27\ Medicare Claims Processing Manual Chapter 30--Financial
Liability Protections. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c30.pdf.
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Ineligibility because the beneficiary is not determined to
be ``terminally ill'' as defined in Sec. 1879(g)(2) of the Act;
Specific items or services that are billed separately from
the hospice payment, such as physician services, are not reasonable and
necessary as defined in either Sec. 1862(a)(1)(A) or Sec.
1862(a)(1)(C); or
The level of hospice care is determined to be not
reasonable or medically necessary as defined in Sec. 1862(a)(1)(A) or
Sec. 1862(a)(1)(C), specifically for the management of the terminal
illness and/or related conditions.
An ABN is not required to be given to a beneficiary for items and
services unrelated to the terminal illness and related conditions.
Additionally, an ABN cannot be issued to transfer liability to the
beneficiary when Medicare would otherwise pay for items and services.
Because the purpose of the ABN is to notify beneficiaries of Medicare
non-coverage and shift financial liability for payment of such services
to the beneficiary, we believe that modifying the ABN for purposes of
notifying the beneficiary of items, services, and drugs not covered by
the hospice as unrelated, may be more confusing for patients in
understanding exactly what the hospice is communicating and how to seek
coverage from other benefits.
The Home Health Change of Care Notice (HHCCN) is provided to
beneficiaries to notify them of home health plan of care changes. That
is, the HHCCN is given to a beneficiary where there is a reduction or
termination of services listed on the home health plan of care due to
physician/provider orders or limitations of the HHA providing the
specific service. While we agree that the HHCCN has some similar
components of the proposed addendum (for example, the addendum would
inform beneficiaries of changes to non-covered items and services and
the reason for the change), there are also inherent differences between
the HHCCN and the proposed addendum. As stated in the FY 2020 hospice
proposed rule (84 FR 17594), the purpose of the proposed addendum is to
inform beneficiaries and their families of those items, services, and
drugs determined by the hospice to be unrelated to the terminal illness
and related conditions, and therefore, not covered by hospice. In other
words, these are determined not to be hospice items, services or drugs
related to the terminal illness, and therefore, would not be considered
the hospice's responsibility to provide. We believe that the addendum
should clearly state that these are items, services, and drugs that the
hospice has determined to be unrelated and therefore, not covered by
the hospice. However, as we are proposing that hospices develop their
own addendum, there is nothing prohibiting them from mirroring forms
such as the HHCCN to facilitate clear communication between the hospice
beneficiary and their representative, as long as the addendum includes
the required elements.
The suggested ``Hospice Change of Care Notice'' sounds very much
like the proposed addendum given the purpose of this suggested change
of care notice is to communicate similar information as the addendum.
However, the timeframes accompanying the suggested ``Hospice Change of
Care Notice'' allow more time to complete the initial and comprehensive
assessment, establish the plan of care with IDG input and secure
agreement of those items unrelated to the terminal illness and related
conditions. As described above, we agree that the timeframe for
completion of the requested addendum should more accurately align with
already existing requirements. However, as stated above, we believe
that the addendum should be clear in its purpose that these are items,
services, and drugs the hospice has determined to be unrelated to the
terminal illness and therefore not the hospice's coverage
responsibility, but may be covered under other Medicare benefits.
We believe that 5 days to complete the addendum, if requested at
the time of a hospice election, should provide adequate time for all of
these activities to occur and is in alignment with the timeframe
requirements at Sec. 418.54(b) for completion of the comprehensive
assessment. We remind hospices that the hospice CoPs at Sec. 418.54(b)
require that the RN, in consultation with the other members of the IDG,
considers the information gathered from the initial assessment as they
develop the plan of care and the group determines who should visit the
patient/family during the first 5 days of hospice care in accordance
with patient/family needs and desires, and the hospice's own policies
and procedures. A hospice does not have to wait 5 days to complete the
comprehensive assessment as hospices may choose to complete the
comprehensive assessment earlier than 5 days after the effective date
of the election (for example, the hospice may complete the
comprehensive assessment at the same time as the initial assessment).
Care planning begins as soon as the individual elects hospice care and
much of the care planning and the decision-making occurs throughout
this period of time, so we believe that completing the addendum within
5 days of the hospice election (or within 72 hours if the addendum is
requested during the course of hospice care) is not unreasonable.
While some commenters suggested adding statements to the addendum
to acknowledge that the patient or patient representative has reviewed
the items, services, and medications with the hospice representative in
order to protect the hospice from inadvertently excluding any
medications or treatments the patient is receiving at the time of
admission, and to acknowledge that a new addendum would be signed if
additional non-covered items, services, or medications are identified
during the course of treatment, we proposed that the addendum would
include a statement that the addendum is subject to review and shall be
updated, as applicable, in writing, to the beneficiary (or
representative). Additionally, we proposed that the addendum would
include a statement that signing the addendum (and any updates) is only
an acknowledgement of receipt of the addendum and not necessarily the
beneficiary's agreement with the hospice's determinations (84 FR
17595). If the beneficiary (or representative) requests the addendum at
the time of the hospice election (that is, at the time of admission to
hospice), hospices could include language on the addendum that those
unrelated conditions, items, services, and drugs are those the hospice
has identified as present on admission and that any changes to this
list (due to new, changing, or inadvertently excluded conditions,
items, services, and drugs) would be reflected in written updates to
the addendum. While we expect hospices to be as thorough as possible
when completing the election statement
[[Page 38513]]
addendum, we recognize that there may be times when they are not aware
of all of the individual's conditions/diagnoses at the time of the
hospice election, which could result in information inadvertently
excluded on the addendum. Consequently, hospices have the option to
make updates to the addendum, if necessary, to include such conditions,
items, services and drugs they determine to be unrelated throughout the
course of a hospice election. We believe that the requirements proposed
and these suggestions would mitigate hospices' concerns regarding any
items, services, or drugs that may have been inadvertently excluded
when completing the addendum.
Given that hospices would develop their own addendum, hospices may
add additional language to inform beneficiaries that the addendum
reflects the most accurate information that they have at the time the
addendum is completed and that updates would be provided, in writing,
if there are any changes that would need to be included based on any
new information.
While some commenters stated that addendum should also address
those items, services, and drugs that may be related, but that the
hospice is not covering, for example a brand name drug as opposed to a
hospice formulary drug, or if a patient requests to continue using a
specific drug that the hospice determines is no longer providing
medical benefit to the patient, we do not think the addendum is the
appropriate mechanism to communicate this information. The
individualized hospice plan of care is developed in accordance with
patient preferences and goals in mind, including those related to
drugs. Decisions about those items, services, and drugs should be made
based on collaboration between members of the interdisciplinary group
(IDG), the patient's attending physician (if any), as well as the
patient and their family. This decision-making would include
determinations of what is reasonable and necessary to meet the care
plan goals. We remind stakeholders that when a beneficiary elects the
hospice benefit, he or she agrees to forego the right to Medicare
payment for services related to the terminal illness and related
conditions unless provided by the hospice. This would mean that if a
beneficiary wants to use a brand name drug instead of its' generic
equivalent, or wants to continue a drug that the hospice has determined
to no longer be reasonable and necessary, the beneficiary is liable for
payment for the drug. The purpose of the addendum is to inform the
beneficiary of those items, services and drugs the hospice has
determined to be unrelated to the terminal illness and related
conditions. The scenario described by these commenters reflects a
situation in which the drug would be related to the terminal illness
and related conditions but is not on the hospice formulary. Therefore,
we believe it would be confusing to provide beneficiaries information
on related items, services, and drugs on the addendum meant to document
unrelated items, services, and drugs not covered by the hospice. While
we do not routinely receive reports of beneficiaries preferring to use
a brand name drug instead of a generic equivalent drug on a hospice's
formulary, we are aware of a few instances in which that to be the
case. Therefore, we will continue to monitor reports of these types of
situations to consider whether the use of the addendum could be
expanded and we would make such proposals in future rulemaking if
warranted.
However, if there is a situation in which the patient wants to
continue with related items, services, and drugs that the hospice has
previously been providing, but that the hospice determines are no
longer reasonable and necessary, or the patient decides to switch to a
brand name drug rather than the generic equivalent on the hospice
formulary, and the hospice provides the item, service, or drug, the
hospice would provide the beneficiary with an ABN to notify the
beneficiary that he or she would be financially liable. If the hospice
does not continue to provide the item, service, or drug, no ABN is
required to be given to the beneficiary.
If the beneficiary desires to continue taking drugs that are not
covered by Medicare Part A (hospice) or Part D, then the hospice must
fully inform the beneficiary of his or her financial liability.
Beneficiaries may also submit quality of care complaints to a Quality
Improvement Organization (QIO) when the beneficiary prefers a non-
formulary drug because, for example, it's believed to be more
efficacious than the formulary drug prescribed by the hospice.
Beneficiaries who disagree with such determinations may continue
raising these issues through the Medicare fee-for-service appeals
process if the determination relates to Part A or B coverage and the
Part D appeals process if the determination relates to Part D coverage.
Whether or not the hospice furnishes the drug, if the beneficiary feels
that the Medicare hospice should cover the cost of the drug, the
beneficiary may submit a claim for the medication directly to Medicare
on Form CMS-1490S. If the claim is denied, the beneficiary may file an
appeal of that determination under the appeals process set forth in
part 405, subpart I.
We note that the hospice CoPs at Sec. 418.56 require a review of
the hospice plan of care at least every 15 days, or more often as the
patient conditions requires. This ensures that there are ongoing
discussions with the beneficiary so that all hospice care is provided
in accordance with patient needs. Similarly, the IDG should be
proactive in developing each patient's plan of care by planning ahead
for anticipated patient changes and needs. Decisions should reflect
patient/family preferences and should not solely be a response to a
crisis.\28\ We believe that the addendum is to be used as a tool to
have these discussions both at the time of hospice election, when care
planning begins, and throughout the course of a hospice election, as
care planning changes to meet the needs of hospice patients and their
families.
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\28\ State Operations Manual Appendix M--Guidance to Surveyors:
Hospice. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_m_hospice.pdf.
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Regarding the use of the current Hospice Information for Medicare
Part D (OMB Form 0938-1269), we note that Part D plan sponsors
currently have a prior authorization process in place for their member
enrolled in hospice for the four categories of drugs (analgesics, anti-
nausea, anti-anxiety, and laxatives). A voluntary, standardized prior
authorization (PA) form was developed with industry input for hospices
to submit to Part D plans in order to assist in:
(1) Proactively avoiding a drug claim from rejecting at point-of-
sale;
(2) Overriding reject edit at point-of-sale; and
(3) Communicating a change in the patient's hospice status.\29\
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\29\ Hospice Information for Medicare Part D Plans, OMB-approved
form (No. 0938-1269). https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/Instruction-and-Form-for-Hospice-and-Medicare-Part-D.pdf.
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Hospices currently can use the standardized PA form as a means of
notifying a Part D plan that their member has elected hospice care, as
well as to document specific drugs that are or are not being covered by
the hospice. We don't agree that use of the Hospice Information for
Medicare Part D (OMB Form 0938-1269) meets the purpose of the addendum
as the Hospice Information for Medicare Part D (OMB Form 0938-1269) is
exclusively for use for the identified four classes of
[[Page 38514]]
drugs (analgesics, anti-nausea, anti-anxiety, and laxatives) for
hospice beneficiaries who are seeking to receive these drugs through
their Part D prescription coverage. Unfortunately, this particular form
is not comprehensive enough to communicate those items, services, and
drugs (not just the four classes) the hospice has determined to be
unrelated to the terminal illness and related conditions.
However, as mentioned in the FY 2020 hospice proposed rule (84 FR
17596), we intend to work with hospices and Part D plans to develop a
process in which the addendum potentially could be used at the point-
of-service when hospice beneficiaries are filling drug prescriptions to
ensure timely access to needed drugs. Complete documentation on the
part of the hospice, coupled with timely notification of Part D
sponsors, mitigates the risk for possible double payment by the
Medicare program for drugs, and is anticipated to prevent Part D
enrollees in hospice from having a hospice related medication billed by
a pharmacy to their Part D plan, potentially subjecting the beneficiary
to out-of-pocket expenses.
Comment: Several commenters report that obtaining signatures on the
addendum statement would be prohibitively challenging. These commenters
cited instances where it is extremely difficult obtaining the patient/
representative signature for the hospice election statement and
expressed concerns about having a requirement to obtain a signature
again on the addendum. Reasons for these challenges included having
representatives who live in a different state from the hospice
beneficiary who may be unable to make healthcare decisions on his or
her own, lack of readily available technology such as patients or
representatives not having email accounts or access to a fax machine in
order to return signed documents. Other commenters asked specific
questions regarding the frequency of providing the addendum and whether
the signature would be required on each version of the addendum.
Another commenter remarked that other providers, such as home health
agencies, are not required to obtain patient/representative signature
for changes to the plan of care and stated that as the addendum would
be similar to a change in the home health plan of care, requirements
for the hospice addendum should be a similar process. A few commenters
requested further guidance regarding the acceptance of an electronic
patient signature for the addendum.
Response: We note that the hospice regulations at Sec. 418.24(b)
require that the patient or representative sign the election statement.
We appreciate the challenges that commenters have identified in
obtaining a signature on the election statement, however, we note that
obtaining the required signatures on the election statement has been a
longstanding regulatory requirement. We expect that hospices already
have processes and procedures in place to ensure that required
signatures are obtained, either from the beneficiary or his or her
representative in the event that the beneficiary is unable to sign and
we expect that the same procedures may be used for obtaining signatures
on the addendum. Likewise, the hospice CoPs at Sec. 418.52(a)(3)
require that the hospice obtain the patient's or representative's
signature confirming that he or she has received a copy of the notice
of rights and responsibilities. Therefore, we believe that it is not
unreasonable to require that the addendum also be signed to ensure that
the patient is aware of the important information about hospice non-
covered items, services, and drugs. As noted previously in this rule
and in the proposed rule (84 FR 17608), the addendum would be signed by
the beneficiary as an acknowledgement that he or she has received this
information, but signing it does not mean the beneficiary agrees with
the determination.
Contrary to commenters' statements that beneficiaries receiving
home health services are not required to sign when there are changes to
the home health plan of care, the HHCCN form (CMS Form 10280) is
completed when there are changes to the home health plan of care due to
a reduction or termination of home health services, and the beneficiary
or representative is required to sign and date the HHCCN confirming his
or her review and understanding of the notice.30 31
Additionally, the home health CoPs at Sec. 484.60(c)(3)(ii) require
that any revisions related to plans for the patient's discharge must be
communicated to the patient, representative, caregiver, all physicians
issuing orders for the HHA plan of care, and the patient's primary care
practitioner or other health care professional who will be responsible
for providing care and services to the patient after discharge from the
HHA (if any). We also remind stakeholders that the HHCCN references
services that are or were provided under the home health plan of care.
Conversely, the addendum is used to communicate items, services, and
drugs that would not be on the initial (or subsequent) hospice plan of
care to ensure coverage transparency where the hospice has determined
that certain items, services, or drugs would not be covered (that is,
furnished and paid for by the hospice) because they are unrelated to
the terminal illness and related conditions.
---------------------------------------------------------------------------
\30\ Form Instructions for the Home Health Change of Care Notice
(HHCCN) CMS-10280. https://www.cms.gov/Medicare/Medicare-General-Information/BNI/Downloads/HHCCN-Form-Instructions.pdf.
\31\ Medicare Claims Processing Manual Chapter 30--Financial
Liability Protections. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c30.pdf.
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In summary, we continue to believe that because of the significance
of the decision to elect hospice care and waive the right to Medicare
payment for care related to terminal illness and related conditions,
the terminally ill individual (and his or her representative) must have
information related to all aspects of their care, including what the
hospice has determined to be ``unrelated''. Requiring the patient to
sign the written addendum memorializes that this important information
has been provided by the hospice to the beneficiary.
Comment: Several stakeholders strongly urged CMS to examine non-
hospice expenditures to determine what proportion is actually the
responsibility of, and within the control of, the hospice before
implementing a mandatory process for hospices. Commenters noted that
there are frequent instances when care is provided to hospice patients
without the hospice's knowledge and the hospice discovers that the
item, service, or drug has been provided only after the fact. An
industry association stated that the language in the proposed rule
presupposes that it is only the hospice's responsibility to communicate
with other providers and offered ideas for improving the flow of
communication between hospice and non-hospice providers. Commenters
noted that other providers may be unaware that a patient has elected
hospice and that they need to coordinate with the patient's hospice to
determine whether the services are unrelated to the terminal prognosis
and that these non-hospice providers must treat claims for hospice
beneficiaries differently with the use of modifiers or a condition
code. These commenters recommended that CMS and Medicare Administrative
Contractors (MACs) provide clear guidance to physicians on billing
requirements for using the GV and GW modifiers and to circulate this
guidance widely in a variety of publications to promote awareness of
these billing requirements as they
[[Page 38515]]
related to non-hospice care for hospice beneficiaries. Some suggested
that non-hospice providers should share in the responsibility of
identifying their patients who are under a hospice election. These
suggestions included making Medicare system changes to allow for a
shortened process that would expedite the notification of election in
the Common Working File (CWF), implementing flags in the Medicare
claims processing systems to notify other provider types of the hospice
election and requiring these other providers to communicate and
coordinate with the hospice, as well as asking beneficiaries and/or
their representative if they are a hospice patient.
Response: While we agree that all participating Medicare providers
should actively engage in ongoing communication and care coordination
to ensure that Medicare beneficiaries receive appropriate care, the
proposed rule primarily focused on the hospice's responsibility in
these activities. The hospice CoPs at Sec. 418.56(e) detail the
requirements of hospice care coordination. Specifically, the hospice
CoPs require that the hospice provide for an ongoing sharing of
information with other non-hospice healthcare providers furnishing
services unrelated to the terminal illness and related conditions.
Furthermore, hospices are required to have systems in place to
facilitate the exchange of information and coordination of services
among staff and with other non-hospice healthcare providers. Likewise,
hospices are required to have documentation in the clinical record of
the sharing of information between all disciplines providing care and
with other healthcare providers furnishing services to the patient.\32\
The goal of this coordination is to ensure that the patient's hospice
plan of care is implemented, and that the hospice care is furnished in
concert with other care sources to ensure that all patient needs are
met (73 FR 32099). We expect the hospice plan of care to address all
patient goals in some way. If a patient has a goal that is not related
to the terminal illness and related conditions, and if the hospice does
not intend to address this goal, then the hospice plan of care should
identify the party that is responsible for meeting the unrelated goal.
Furthermore, Sec. 418.56(e) requires the hospice to actively
communicate with the outside party to ensure that the goal is
addressed. Therefore, given the comprehensive nature of the Medicare
hospice benefit and the CoPs regarding the pivotal role hospices are
required to play in care coordination, we believe hospices are
primarily responsible for communication and care coordination with non-
hospice providers while a beneficiary is under a hospice election.
Likewise, the requirement that care is provided under the direction of
an IDG means that the approach to patient care under hospice is
holistic and requires the hospice to be primarily responsible for the
medical, emotional, and spiritual care of the individual.
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\32\ State Operations Manual Appendix M--Guidance to Surveyors:
Hospice. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_m_hospice.pdf.
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To address comments regarding physician education on the
appropriate use of the GW and GV modifiers, we remind stakeholders that
CMS does routinely provide information on various aspects of the
Medicare program include educational materials on Medicare benefits and
claims processing. There is a MLN Matters[supreg] article, ``Hospice
Related Services--Part B'', intended for physicians submitting claims
to Medicare Administrative Contractors (MACs) for services provided to
Medicare beneficiaries who are in a hospice period of coverage.\33\
Likewise, the Medicare claims processing manual, chapter 11,
``Processing Hospice Claims'' includes detailed information on the
appropriate use of the GW and GV modifiers. We believe these are the
most appropriate CMS mechanisms for providing such information to
physicians and other providers of services.
---------------------------------------------------------------------------
\33\ MLN Matters[supreg]Number: SE1321, Hospice Related
Services--Part B.November 2014. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1321.pdf.
---------------------------------------------------------------------------
To address comments regarding making changes to the Medicare
systems to allow for a shortened process to update the CWF, we note
that CWF processing time still varies because of whether an NOE must go
through the one-time out of service area (OSA) process. OSA processing
occurs when a beneficiary's master record is not found on the local CWF
host site for the MAC and several nightly batch cycles are required to
query each of the other host sites to find it. This process is standard
for all claims and cannot be revised just for hospice without creating
risk for all other Medicare payments. While Electronic Data Interchange
(EDI) submission of NOEs does not affect the processing time in CWF, it
reduces delays caused by keying errors. Once the NOE is accepted at
CWF, the hospice record is available for all providers on the HIPAA
(Health Insurance Portability and Accountability Act) Eligibility
Transaction System (HETS) inquiries. The HETS allows providers to check
Medicare beneficiary eligibility data in real-time. Providers are
encourage to use HETS to prepare accurate Medicare claims, determine
beneficiary liability, or check eligibility for specific services.
Comment: A few commenters expressed concern over the role of the
QIO when beneficiaries disagree with the hospice determination as to
those items, services, and drugs. These commenters disagreed with
having to include QIO information on the election statement given
hospices are already required to provide information to beneficiaries
regarding QIOs at hospice admission. Other commenters expressed
concerns over how QIO determinations would be made, given that these
determinations are within the scope of a hospice physician who has
medical information in the clinical record with which to base such a
determination. These commenters stated that unless the QIO reviewer is
a physician with experience/training in end-of-life care and has
sufficient information, the QIO reviewer could not make a determination
as to whether the hospice's determination of unrelatedness is correct
and appropriate. Commenters request additional clarity about the BFCC-
QIO findings and how the hospice is to implement them so there is no
confusion regarding the authority of the BFCC-QIO, the hospice medical
director, and the MACs when determining relatedness, eligibility, and
continued coverage of hospice services.
A few commenters remarked that the crux of the issue is the lack of
guidelines provided by CMS as to how determinations of relatedness are
made, other than it is the responsibility of the hospice physician. One
commenter stated that relatedness is vague. One industry association
reiterated that there is a lack of clarity around what ``relatedness''
means and that guidance should be updated and be more specific. This
commenter stated that the repeated requests for clarification
underscores the reality of how decisions are being made. This commenter
went on to state that there are those hospices that have a broad,
holistic view and philosophy of care that is in alignment with CMS'
intent and is aligned with their organizational mission and values,
though this commenter remarked that there are those hospices that take
advantage of the ``gray space'' and manipulate the system to avoid
payment of items, services, and drugs that should be the hospices'
responsibility. Finally,
[[Page 38516]]
this commenter recommended that CMS work with stakeholders to develop
more standardized definitions of related and unrelated in order to
promote consistency of delivery across the benefit and where the need
for an addendum would be unnecessary as a result.
Response: We remind stakeholders that Immediate Advocacy with the
Beneficiary and Family Centered Care Quality Improvement Organization
(BFCC-QIO) is an informal alternative dispute resolution process used
to quickly resolve a Medicare beneficiary's (or his or her
representative's) verbal complaint regarding the quality of Medicare-
covered health care received or services that accompany medical care
(for example, medical equipment). This process involves the BFCC-QIO
directly contacting the beneficiary's practitioner or provider, usually
by telephone. The process is voluntary for both the beneficiary and the
provider or practitioner. The purpose of Immediate Advocacy is to
provide a flexible, dialogue-based resolution process between the
beneficiary and the provider.
There are specific criteria for eligibility for Immediate Advocacy.
A QIO may offer Immediate Advocacy to the beneficiary prior to
obtaining a written beneficiary complaint when the following criteria
are met:
1. After initially screening the complaint, the QIO determines the
complaint was received within 6 months from the date of service on
which the care occurred concerning the complaints and:
a. The beneficiary complains about a matter that is unrelated to
the clinical quality of health care itself but that relates to items or
services that accompany or are incidental to the medical care and are
provided by a practitioner and/or provider (for example, beneficiary in
search of or needing an intervention for resources and/or services
covered by Medicare, such as a wheelchair that was not delivered, a
beneficiary concerned about the quality of communication with their
practitioner and/or provider); or
b. The beneficiary complains about a matter that, while related to
the clinical quality of health care the beneficiary received, does not
rise to the level of being a ``gross and flagrant,'' ``substantial,''
or ``serious or urgent'' quality of care concern. This may include
situations where the QIO determines that the medical information will
most likely not contain evidence related to the complaint.
2. The beneficiary agrees to the disclosure of his or her name. (42
CFR 476.110(a)(3)).
3. All parties orally consent to the use of Immediate Advocacy. (42
CFR 476.110(a)(4)).
4. All parties agree to the limitations on redisclosure; namely,
all communications, written and oral, exchanged during the Immediate
Advocacy process must not be redisclosed without the written consent of
all parties (42 CFR 476.110(c) and 480.107).
If the practitioner/provider opts NOT to participate in the
Immediate Advocacy process, the QIO must immediately contact the
beneficiary and give him or her the opportunity to file his or her
complaint in writing.\34\
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\34\ Quality Improvement Organization Manual Chapter 5--Quality
of Care Review. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/qio110c05.pdf.
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As noted previously, the regulations at Sec. 476.110 set forth the
requirements as they relate to the Immediate Advocacy process which is
meant to be an informal alternative dispute resolution process used to
quickly resolve an oral complaint a Medicare beneficiary or his or her
representation has regarding the quality of Medicare covered health
care received. This process involves a QIO representative's direct
contact with the provider and/or practitioner. When a quality of care
complaint is handled through the Immediate Advocacy process, the QIO
does not make clinical determinations based on whether or not it agrees
with the hospice's determination about whether or not the disputed
items, services, or drugs are unrelated to the terminal illness and
related conditions, but rather facilitates discussion between the
beneficiary and the hospice to see if the two parties can come to a
satisfactory resolution. While it cannot require services be covered,
provided, or be paid for by Medicare, the BFCC-QIO addresses quality of
care issues for Medicare beneficiaries. Additionally, with the
agreement to use Immediate Advocacy, a Peer Review is not performed. A
Peer Review is a review by health care practitioners of services
ordered or furnished by other practitioners in the same professional
field and is generally part of the written complaint process through
the QIO. If the QIO receives a written complaint, Immediate Advocacy
may not be offered; rather the written complaint would be subject to
the Beneficiary Complaint Review Peer Review process.\35\ Furthermore,
medical information should not be requested from the practitioner or
provider for this Immediate Advocacy process. While the goal of
Immediate Advocacy is to informally and quickly resolve the
beneficiary's complaint, in certain instances the beneficiary might
remain dissatisfied after completion of Immediate Advocacy. Should this
occur, the QIO must advise the beneficiary of his or her right to file
a written complaint. Therefore, we reiterate to commenters that the
role and scope of the BFCC-QIO's Immediate Advocacy authority is
limited, as described in regulation.
---------------------------------------------------------------------------
\35\ Quality Improvement Organization Manual Chapter 5--Quality
of Care Review. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/qio110c05.pdf.
---------------------------------------------------------------------------
We also remind commenters that the hospice medical director must
consider all health conditions, whether related or unrelated to the
terminal condition, as well as current clinically relevant information
supporting all diagnoses when making the decision to admit a patient
into hospice (42 CFR 418.25). Additionally, all hospice care and
services furnished to patients and their families must follow the
individualized written plan of care established by the hospice
interdisciplinary group in collaboration with the attending physician
(if any), the patient or representative, and the primary caregiver in
accordance with the patient's needs if any of them so desire (42 CFR
418.56). The hospice must ensure that each patient and the primary care
giver(s) receive education and training provided by the hospice as
appropriate to their responsibilities for the care and services
identified in the plan of care. The plan of care must specify the
hospice care and services necessary to meet the patient and family-
specific needs identified in the comprehensive assessment as such needs
relate to the terminal illness and related conditions (42 CFR 418.56).
Based on this information, each hospice makes the determination as to
what items, services, or drugs are considered related to the terminal
illness and related conditions, and belong on the plan of care.
However, that is not to say that these determinations cannot be
questioned by the beneficiary, or his or her representative. Therefore,
the addendum is to provide the information on hospice determinations as
to what unrelated items, services, and drugs it will not be covering to
spur conversations with the patient about these determinations and the
impact on the patient. In addition, Immediate Advocacy is a process in
which the beneficiary can question such determinations.
[[Page 38517]]
In response to comments regarding concerns about the vagueness of
``relatedness'' and requests for additional CMS guidance as to what is
``related'' and ``unrelated'', we remind commenters that since the
implementation of the Medicare hospice benefit, it has been our
position that virtually all of the care needed by terminally ill
individuals should be provided by the hospice (48 FR 56010). As such,
there should not be a voluminous list of unrelated items, services, and
drugs given the comprehensive nature of hospice services under the
Medicare hospice benefit and the requirement that the hospice provide
care addressing the physical, medical, psychosocial, emotional, and
spiritual needs of hospice patients and families facing terminal
illness and bereavement. We note that in the FY 2015 hospice proposed
rule (79 FR 26538) we solicited comments on definitions of ``terminal
illness and related conditions.'' We received a significant number of
comments on these definitions, with most commenters opposing CMS
proposing these definitions. Commenters stated that hospices were the
experts at making such clinical determinations and that the statute and
hospice regulations allow for hospices to make such determinations.
Commenters noted that the hospice should be the entity that establishes
a process to make determinations as to what is related and unrelated to
the terminal illness and related conditions on a patient-by-patient
basis. Due to this feedback, we have not proposed definitions for
``terminal illness or related conditions''.
We understand that national industry associations have subsequently
engaged in activities with hospices to communicate a process for
helping hospices make these relatedness determinations in the form of
clinical decision-making process workflows.\36\ We appreciate these
efforts and ongoing dialogue amongst the hospice industry in addressing
best practices in making clinical decisions to provide comprehensive
and holistic care to hospice beneficiaries and their families.
---------------------------------------------------------------------------
\36\ Determining Relatedness to the Terminal Prognosis Process
Flow, National Hospice and Palliative Care Organization. December
2014. https://wshpco.org/media/Relatedness_Process_Flow_FINAL_2.14.pdf.
---------------------------------------------------------------------------
Comment: Some commenters suggested that rather than implement
sweeping regulations required of all hospices, CMS should implement a
more targeted approach by analyzing data to identify hospices that are
out of compliance with the coverage of DME and disease-specific drugs
and penalizing them directly for failure to provide such services. One
commenter remarked that most hospices provide all items, services, and
drugs in good faith and in accordance with Medicare regulations and
therefore should not be subject to unnecessary requirements. Another
commenter recommended that CMS take additional steps to identify the
breadth of the issues contributing to non-hospice spending and address
inappropriate spending outside of the hospice benefit accordingly.
Specifically, this commenter suggested that CMS determine what
proportion of hospice spending is occurring within the first few weeks
of hospice care when the CMS systems have not been updated with
Medicare notice of election information and where the hospice is
informing non-hospice providers that the item, service, or drug is
unrelated. One commenter stated that a simple solution would be to
block all Medicare services without hospice approval. One commenter
wrote that the addendum proposal would make hospices look like ``the
bad guy'' in communicating those items, services, and drugs they have
determined to be unrelated even if the hospice is providing this
information in good faith.
Response: For those providers who do furnish all items, services
and drugs for hospice patients, this requirement would be met in that
there would be no request for an addendum as the hospice would be
furnishing all of the patient's care needs. We remind stakeholders that
the hospice regulations are applicable to all Medicare-participating
hospice providers. Program integrity audits and survey actions are
appropriate mechanisms to enforce the payment regulations and the CoPs.
If there are identified program integrity concerns or CoP violations,
the appropriate targeted actions can then be taken for those who do not
meet the requirements.
To reduce the incidence of inappropriate payments for beneficiaries
under a hospice election, hospices are required to submit a Notice of
Election (NOE with its Medicare contractor within 5 calendar days after
the effective date of the election statement. The purpose of a timely-
filed the NOE is to alert the Medicare claims processing system that a
beneficiary is under a hospice election to avoid inappropriate or
duplicative payments to other Part A, Part B, or Part D providers, and
to safeguard beneficiaries from inappropriate liability for copayments
or deductibles.
We have been analyzing non-hospice spending for a number of years
and have been presenting information on the breadth of this issue in
proposed and final rules (for instance, our FY 2016 hospice wage index
proposed rule at 80 FR 25849, and our FY 2019 hospice wage index
proposed rule at 83 FR 20946). We also note that in examining non-
hospice spending, we have excluded admission and discharge dates as
part of our analysis. In the future, we will consider examining other
time points of non-hospice spending, including the proportion of
spending that is occurring in the first 5 days of a hospice election
where the claims processing system may not yet be aware of the hospice
election.
We oppose blocking all beneficiary access to services ordinarily
covered by Medicare without hospice approval because the complexity of
instituting such a process would potentially delay access to needed
items, services, and drugs.
Non-hospice providers are already required to submit claims with
the appropriate modifier when furnishing services to beneficiaries
under a hospice election. Non-hospice providers are required to report
the GW modifier (or condition code 07 for institutional providers) to
identify that services were unrelated to the terminal illness and
related conditions or the GV modifier to identify that services were
related to the terminal illness and related conditions. For
beneficiaries enrolled in hospice, A/B MACs (B) shall deny any services
on professional claims that are submitted without either the GV or GW
modifier. Therefore, there is already a mechanism in place to prevent
inappropriate payments during a hospice election. As we stated in the
FY 2020 proposed rule (84 FR 17597), we also believe that the addendum
may allow the non-hospice provider to be ``without fault'' if there is
any question regarding an overpayment. In accordance with section 1870
of the Act, a provider is responsible for an overpayment if the
provider knew or had reason to know that service(s) were not reasonable
and necessary, and/or the provider did not follow correct procedures or
use care in billing or receiving payment. If non-hospice providers were
given access to a patient's addendum, this potentially could provide
evidence under section 1870 of the Act in demonstrating that the non-
hospice provider did or did not have reason to know that the services
provided by the non-hospice provider were duplicative, or otherwise not
reasonable and necessary (considering the service itself was otherwise
reasonable and necessary and satisfied all other requirements for
payment). Moreover, if a non-hospice provider submitted a claim to
Medicare for
[[Page 38518]]
services provided to a beneficiary that were unrelated to the terminal
illness and related conditions but did not have the supporting
documentation demonstrating that the services were unrelated, this
could, among other things, delay payment. Having the addendum
identifying the unrelated conditions, items, services, and drugs may
provide the necessary documentation support that the non-hospice
provider was rendering services unrelated to the terminal illness and
related conditions. Therefore, the addendum could assist in more
accurate claims submission, mitigate potential duplicative payments,
and provide non-hospice providers with documentation to support a
``without fault'' determination.
Finally, we disagree that the purpose of furnishing an addendum to
communicate hospice non-covered, unrelated items, services, and drugs
is to make the hospice look like ``the bad guy''. Again, hospices are
already required to inform beneficiaries of coverage under the Medicare
hospice benefit. As such, providing this information supports the
philosophy of care of putting patients first, promoting patient choice,
and advocating for patient autonomy.
Comment: A majority of commenters opposed the proposal that the
addendum be a condition for payment. Many commenters suggested that
instead of a condition for payment, the proposed addendum should be a
CoP, as they believe that protection of patient rights is more
appropriately reviewed under the survey oversight process. Commenters
stated that in order for the proposed addendum to be a condition for
payment, there would need to be a standardized process of recording any
unrelated items, services, and drugs and documenting whether or not the
addendum was requested in the patient's medical record. Several
commenters questioned how an addendum that is mandatory, but only upon
request, could be appropriately used as a condition for payment. Many
commenters expressed concern over the implications for auditing under
medical review. Specifically, commenters asked how to protect
themselves from claims denials if there is no addendum (or addendum
updates) present in the medical record because there was no patient (or
representative) or provider request. Others question whether the MACs
would use the addendum for claims denials if the MAC disagrees with the
hospice's determinations. A national industry association stated that
the process to determine whether the addendum was requested, when it
was requested, whether it is present, and whether the condition for
payment requirement has been met, is fraught with issues. Several
commenters requested that CMS develop specific protections to prevent
claims denials solely because an addendum is not in the medical record
and to state that the addendum would not be used to dispute
determinations of relatedness which could result in claims denials. A
few commenters thought that the addendum should be provided to every
hospice beneficiary, whether requested or not, to protect the hospice
from claims denials resulting from missing addendums in patients'
medical records. A few commenters stated that the vast majority of
patients have no unrelated conditions and therefore it seems
unnecessary to require such a form. Another commenter believed that the
addendum would have a chilling effect at the time of hospice election
and may deter admissions, especially for those patients who are
reluctant to discontinue certain services and drugs, like maintenance
medications.
Response: While we understand stakeholder concerns about including
an addendum statement as a condition for payment, we believe this is
necessary to ensure that hospices are diligent in providing this
information to Medicare hospice beneficiaries on request. We regard
this addendum as an important mechanism of accountability for hospices
to provide coverage information to beneficiaries electing the hospice
benefit. We also believe that the various reports by the OIG (for
example; OEI-02-16-00570, July, 2018, ``Vulnerabilities in the Medicare
Hospice Program Affect Quality Care and Program Integrity: An OIG
Portfolio,'' \37\ and A-06-10-00059, June 2012, ``Medicare Could Be
Paying Twice For Prescription Drugs For Beneficiaries In Hospice'')
\38\ highlight the issues with a patient's lack of knowledge of
hospices' limitation on their coverage, and the possibility of hospices
potentially not covering items, services, and drugs that should be
hospices' responsibility. We reiterate that the election statement
addendum, as a condition for payment, would achieve the goal of
increasing comprehensive patient education, awareness, empowerment, and
coverage transparency. As stated in the FY 2020 hospice proposed rule,
this does not mean that in order to meet this condition for payment
that the beneficiary (or representative), or non-hospice provider must
agree with the hospice's determination. For purposes of this condition
for payment, the signed addendum is only acknowledgement of the
beneficiary's (or representative's) receipt of the addendum (or its
updates) and this payment requirement would be met if there was a
signed addendum (and any signed updates) in the requesting
beneficiary's medical record with the hospice. Likewise, this addendum
would not be required to be submitted with any hospice claims. While we
agree that this could be a CoP as opposed to a condition for payment,
we continue to believe that as a condition for payment, this would
ensure a more comprehensive and thoughtful approach by hospices in
communicating important coverage information to beneficiaries.
---------------------------------------------------------------------------
\37\ Vulnerabilities in the Medicare Hospice Program Affect
Quality Care and Program Integrity: An OIG Portfolio. July 2018.
https://oig.hhs.gov/oei/reports/oei-02-16-00570.pdf.
\38\ Medicare Could Be Paying Twice for Prescription Drugs for
Beneficiaries in Hospice (A-06-10-00059). June 2012. https://oig.hhs.gov/oas/reports/region6/61000059.pdf.
---------------------------------------------------------------------------
We agree that it would be helpful for hospices to have a
standardized documentation process for recording any unrelated items,
services, and drugs and expect that many hospices may already have a
documentation process in place, given the existing requirements for
admission to hospice and development of the individualized plan of
care. We would expect hospices to document, in some fashion, that the
addendum was discussed with the patient (or representative) at the time
of admission, similar to how other patient and family discussions are
documented. Likewise, hospices can develop a way to document whether or
not the addendum was requested at the time of hospice election (or at
any time throughout the course of hospice care). This could be done in
checklist format or as anecdotal notes by the nurse. However, we did
not propose a specific format in which to document such conversations
and hospices can develop their own processes to incorporate into their
workflow. We believe that careful documentation that the addendum was
discussed and whether or not it was requested would be an essential
step hospices could take to protect themselves from claims denials
related to any absence of an addendum (or addendum update) in the
medical record.
We are aware of commenter concerns about the potential for this
addendum to be used for medical review auditing purposes if it is a
condition for payment. We note that there is no current process for the
MACs to make determinations of ``relatedness''. We remind commenters
that the regulations
[[Page 38519]]
afford hospices this responsibility in accordance with the CoPs at
Sec. 418.56. Therefore, the hospices' determination of those unrelated
items, services, or drugs reported on the addendum could not be used
solely to deny hospice claims. Nonetheless, to assuage commenter
concerns about increased claims denials and documentation requests, we
will collaborate with the MACs to establish clear guidelines on the use
of the addendum as a condition for payment and we will propose any
requirements in future rulemaking, as necessary. We do not want
hospices to perceive that the purpose of this addendum is punitive
against hospices, nor that it is a mechanism to deny claims; rather we
want hospices to understand that the intent of this addendum is to keep
patients at the forefront of their decision-making equipped with
adequate information to make care choices as they approach the end of
life.
While hospices can choose to provide the addendum to every electing
beneficiary, we are not requiring that it is mandatory, unless the
patient (or representative) requests the addendum. We encourage
hospices to review their current admission processes to see how the
addendum could assimilate into their procedures to help ameliorate any
issues upon implementation. We believe that because hospices already
should have processes in place to make determinations about those
items, services, and drugs that they will not cover because they are
unrelated to the terminal illness and related conditions, hospices will
be able to adapt the addendum into their current processes.
Finally, we disagree that the provision of the addendum would have
a ``chilling effect'' on hospice admissions. Generally, beneficiaries
make decisions that are based on information furnished by providers
rendering care. We continue to assert that the information provided in
the addendum will allow beneficiaries to make those decisions to best
meet their preferences and goals of care and will mitigate any
unexpected need to seek services outside of the hospice and assume the
associated cost-sharing. We believe beneficiaries and their families
would appreciate full disclosure from the hospice as to what to expect
when electing the Medicare hospice benefit.
Comment: The majority of commenters agreed that if the addendum is
finalized, the effective date should be delayed until FY 2021, at
minimum, in order to ensure that hospices and software vendors have
adequate time to develop the addendum, modify the existing election
statement to include the new content requirements, and develop and
educate on the protocols and procedural changes necessary to
incorporate the addendum into hospice work flow processes, as well as
work with non-hospice providers to ensure compliance.
Response: We understand that making modifications to the election
statement and developing an addendum to accompany the election
statement will take time for hospices to create, educate staff, and
incorporate into current admission processes. Likewise, we recognize
that there are some additional logistical and operation considerations
(see response below) that we will need to consider and communicate to
the hospice industry to help ensure a more seamless implementation.
Therefore, we will finalize an effective date of FY 2021 for the
election statement modifications and the addendum. This delayed
effective date will allow sufficient time for us to develop a model
election statement addendum to provide the industry as they move
forward making the changes to their own election statements and as they
develop an addendum to communicate those items, services, and drugs
they will not be covering because they have determined them to be
unrelated to the terminal illness and related conditions. This
additional year will allow hospices to make any current process and
software changes to incorporate the addendum into their workflow.
Comment: Many commenters stated that CMS underestimated the amount
of time it would take for the nurse to complete the addendum stating
that 10 minutes is an insufficient amount of time to extrapolate this
information from the existing documentation. A few commenters stated
that this would take between 20 and 30 minutes to complete. Others
stated that this is not just a process of extrapolating the
information, but that this is often a process of information gathering
as not all relevant information is readily available at the time of the
initial assessment. However, a few commenters believed that even though
the timeframe to complete the addendum would be longer than 10 minutes,
they suggested that the addendum should not be optional but patients
(or their representatives) should be provided this detailed list as
this is critical to the care process, patient empowerment, quality of
care, and transparency. One commenter stated that the addendum proposal
would be improved by adding appropriate reimbursement for the time and
process redesign needed to make this a successful addition to hospice
practice.
Additionally, the majority of commenters stated that this would
significantly increase burden for hospices, as well as for patients and
their families and could potentially impede access to care stating that
this conflicts with CMS' Patients over Paperwork initiative. Commenters
cited such concerns as the increase in time spent gathering,
documenting, and communicating this information, as well as providing
copies of such information, in writing, to patients, their
representatives, non-hospice providers, and Medicare contractors.
Response: While we understand commenter concerns over the time it
takes to complete the addendum, we remind hospices that the addendum is
not a requirement for every electing beneficiary. Several commenters
stated that because they do provide such a comprehensive range of
services most beneficiaries would not need an addendum. We continue to
believe that once a beneficiary elects the hospice benefit, most items,
services, and drugs would be for the palliation and management of the
terminal illness and related conditions and that there would be few
things that would be unrelated.
Furthermore, because hospices should already be considering those
items, services, and drugs they have determined to be unrelated as part
of the admission and care planning process, we believe that providing
such information, in writing, to the beneficiary (or representative)
should not take a significant amount of time. Additionally, hospices
would develop their own addendums, in a format that suits them to best
meet the requirements and patient needs while minimizing operational
burden. We also stated in the proposed rule that we would develop a
model addendum to help hospices in developing their own. Several
commenters stated that most hospices use the current model election
statement so we trust that hospices would take advantage of the model
addendum to help mitigate any burden in developing their own addendum
to meet this requirement.
Additionally, we are finalizing expansion of the time to complete
the addendum to 5 days in accordance with the timeframe to complete the
comprehensive assessment. This means that if a requesting beneficiary
dies within the first 5 days of the hospice election, hospices would
not be required to complete any requested addendum as this requirement
would be deemed as being met in this circumstance. Given that almost 28
percent of beneficiaries die within the first 5 days of hospice care,
this would
[[Page 38520]]
further reduce hospice burden. We have recalculated the burden estimate
in section IV. of this final rule to account for the expanded timeframe
to complete the addendum where there would be fewer eligible elections
subject to this requirement and thus, less burden on hospices.
We agree with those commenters who stated that the addendum would
be critical in the care process and would promote patient empowerment,
quality of care, and transparency. However, we are not making this a
mandatory requirement for all hospice elections; we reiterate that the
requirement is that the addendum would be provided only upon request as
we believe this would best achieve coverage transparency without
imposing undue burden on hospices. Likewise, because we believe that
hospices should already have processes in place to make determinations
of unrelatedness, additional payment should not be made for completion
of the addendum.
Finally, while we recognize that the addendum, may result in a
small increase in operational burden for some hospices, we believe this
burden is outweighed by our initiative to put patients first. We
believe that if a requirement results in promoting patient choice,
autonomy, and coverage transparency then it is within the framework of
this initiative.
Comment: In addition to the comments summarized above, we received
numerous comments from hospices, industry associations, and other
stakeholders who stated concerns with operational and logistical
aspects of the addendum policy. Furthermore, commenters wrote that CMS
drastically underestimated the operational complexity and the impact
this particular requirement would have on hospice providers and
patients.
Generally, commenters had questions on the logistics of delivering
the addendum to the patient and family within 48 hours, the clinician
who would be responsible for delivering the addendum, and whether this
would require the nurse to have a mobile printer to deliver such
information. Others asked what the expectations would be when there are
changes to the plan of care after admission; whether the timeframe is
based on when CMS accepts the election or when the provider submits the
NOE; what provisions would be made for weekends and holidays; what
education would be provided to MACs and the BFCC-QIOs regarding their
role in this process; how CMS would expect evidence that the unrelated
items, services, and drugs were discussed at admission or at other time
points during a hospice election; documentation requirements in the
medical record referencing the addendum, including who requested such
information and when; what CMS means when we state that the clinical
rationale should be provided in ``language a beneficiary can
understand''; how CMS would determine whether the clinical rationale is
adequately supported; and how differences between clinical opinion
between the hospice physician and non-hospice providers would be
handled.
Response: We realize that commenters have concerns over some of the
operational and logistical details of developing and implementing an
addendum to communicate, in writing, those items, services, and drugs
the hospice will not cover as they have been determined by the hospice
to be unrelated to the terminal illness and related conditions. As
mentioned previously, hospices have asked for additional guidance and
details on some of these issues including the submission of handwritten
versus electronic signatures, expectations of the type of documentation
expected in the medical record regarding whether or not the addendum
was requested; what documentation would be requested by the MACs when
an Additional Documentation Request (ADR) is made; whether the addendum
could be provided in an electronic format; the provision of MAC and
BFCC-QIO education, among others. Some of these issues have been
addressed in previous responses in this final rule.
Because of some of the issues brought to light by commenters, we
will delay the effective date for implementation of the election
statement modifications and the addendum until FY 2021 to allow
additional consideration of these operational and logistical issues.
This will allow CMS more time to fully investigate the details brought
up by commenters specifically regarding operational and auditing
processes, training and education, and we will engage in rulemaking for
FY 2021 as necessary to seek any additional comments on any operational
or logistical proposals.
Final Decision: We are finalizing the election statement
modifications as proposed. We are also finalizing our proposal that the
addendum be titled ``Patient Notification of Hospice Non-Covered Items,
Services, and Drugs'' and would include the following content
requirements:
1. Name of the hospice;
2. Beneficiary's name and hospice medical record identifier;
3. Identification of the beneficiary's terminal illness and related
conditions;
4. 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;
5. 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 would be accompanied by a
general statement that the decision as to whether or not conditions,
items, services, and drugs is related is made for each patient and that
the beneficiary should share this clinical explanation with other
health care providers from which they seek services unrelated to their
terminal illness and related conditions;
6. References to any relevant clinical practice, policy, or
coverage guidelines.
7. Information on the following domains:
a. Purpose of Addendum
b. Right to Immediate Advocacy
8. Name and signature of 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.
We are finalizing that the election statement modifications apply
to all hospice elections but the addendum only would be furnished to
beneficiaries, their representatives, non-hospice providers, or
Medicare contractors who request such information. Additionally, we are
finalizing our policy that if the beneficiary (or representative)
requests an addendum at the time of hospice election, the hospice would
have 5 days from the start of hospice care to furnish this information
in writing. We are finalizing our proposal that if the beneficiary
requests the election statement 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. If the addendum is requested during the course of hospice
care (that is, after the date of the hospice election), we are
finalizing that the
[[Page 38521]]
hospice would have 72 hours from the date of the request to provide the
written addendum. We are finalizing our proposal that the election
statement modifications and the addendum be effective for hospice
elections beginning on and after October 1, 2020 (that is, FY 2021). As
noted previously, we will continue to examine some of the operational
and logistical issues highlighted by commenters to determine if any
additional proposals are required for FY 2021 rulemaking.
At Sec. 418.24(b), we are finalizing the provisions regarding the
election statement modifications and the election statement addendum.
In addition, we made several revisions to Sec. 418.24. Specifically,
we redesignated paragraphs (c) through (f) as paragraphs (d) through
(g). This redesignation would affect two cross-references in Sec.
418.26(c)(2) and Sec. 418.28(c)(2). As a result, we made conforming
changes to accompany the redesignations in Sec. 418.24. Likewise, at
Sec. 418.3, we define the term BFCC-QIO as the Beneficiary and Family
Centered Care Quality Improvement Organization. Because these
conforming changes were not proposed in the proposed rule, we are
adopting them here under a ``good cause'' waiver of proposed
rulemaking. The specific changes we are making in the regulations
simply codify the final policies we described in the proposed rule and
do not reflect any additional substantive changes.
D. Request for Information Regarding the Role of Hospice and
Coordination of Care at End-of-Life
In the FY 2020 Hospice Wage Index and Rate Update proposed rule (84
FR 17598), we solicited public comments on the interaction of the
Medicare hospice benefit and various alternative care delivery models,
including Medicare Advantage (MA), Accountable Care Organizations
(ACOs), and other future models designed to change the incentives in
providing care under traditional FFS Medicare. We specifically sought
public comments on how hospice under Medicare FFS relates to other
treatment options, how it impacts the provision of a spectrum of care
for those that need supportive and palliative care before becoming
hospice eligible and after, and whether rates of live discharge are a
reflection of the current structure of Medicare FFS. We further
solicited comments on any care coordination differences for hospice
patients that received Medicare through traditional FFS prior to a
hospice election, were enrolled in an MA plan prior to hospice
election, or received care from providers that participate in an ACO
prior to a hospice election.
We appreciate the thoughtful input and suggestions provided by
commenters in response to this request for information (RFI). We
generally do not summarize or respond to comments in the final rule for
requests for information as the purpose of such requests is to help CMS
for future rulemaking or the development of models through CMS'
Innovation Center. However, as we continue to review the comments
received, we believe that the information gathered under this RFI will
help inform: (1) Future CMS payment models; (2) the role of hospice
with respect to ACOs; and (3) our general understanding of the
traditional FFS hospice environment in relation to the increasing
penetration of managed care through the MA program.
E. Updates to the Hospice Quality Reporting Program (HQRP)
1. Background and Statutory Authority
The Hospice Quality Reporting Program includes meeting the
reporting requirements for both the Hospice Item Set (HIS) and Consumer
Assessment of Healthcare Providers and Systems (CAHPS[supreg]) Hospice
Survey. Section 3004(c) of the Affordable Care Act amended section
1814(i)(5) of the Act to authorize a quality reporting program for
hospices. 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 for that FY.
Depending on the amount of the annual update for a particular year, a
reduction of 2 percentage points could result in the annual market
basket update being less than 0 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 particular year involved. 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.
2. Update to Quality Measure Development for Future Years
As stated in the FY 2019 Hospice Wage Index and Payment Rate Update
and Hospice Quality Reporting Requirements (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. The Meaningful Measures initiative is not
intended to replace any existing programs, but will help programs
identify and select individual measures. The Meaningful Measure
Initiative areas are intended to increase measure alignment across our
programs and other public and private initiatives. Additionally, it
will point to high priority areas where there may be gaps in available
quality measures while helping to guide our efforts to develop and
implement quality measures to fill those gaps. More information about
the Meaningful Measures initiative can be found at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
The Meaningful Measures initiative fits well with the HQRP since it
has changed little since we began with FY 2014 Hospice Wage Index and
Payment Rate Update final rule (76 FR 26806). The Meaningful Measures
initiative enables us to review the HQRP in order to close the gaps in
quality measures to reflect the hospice industry as it has progressed
to meet hospice care, including symptom management for its patients
regardless of where hospice care is provided.
In the FY 2014 Hospice Wage Index and Payment Rate Update final
rule (78 FR 48257), and in compliance with section 1814(i)(5)(C) of the
Act, we finalized the specific collection of data items that support
the following 7 National Quality Forum (NQF)-endorsed measures for
hospice:
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).
We finalized the following two additional measures in the FY 2017
Hospice Wage Index and Payment Rate Update final rule, effective April
1,
[[Page 38522]]
2017. Data collected will, if not reported, affect payments for FY 2019
and subsequent years. (81 FR 52163 through 52173):
Hospice Visits when Death is Imminent,
Hospice and Palliative Care Composite Process Measure--
Comprehensive Assessment at Admission.
The Hospice and Palliative Care Composite Process Measure--
Comprehensive Assessment at Admission measure (hereafter referred to as
``the Hospice 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. Data for the
``Hospice Visits when Death is Imminent'' measure pair is being
collected using new items added to the HIS V2.00.0, effective April 1,
2017.
Our goal is to identify measures that provide a window into hospice
care throughout the dying process, fit well with the hospice business
model, and meet the objectives of the Meaningful Measures initiative.
Quality measures should provide timely, understandable, comprehensive,
clinically valid, and meaningful feedback to hospice leadership, all of
its staff, and their different teams regardless of the hospice setting
where care is provided. We solicited public input on measure concepts
and actual quality measures, along with public comment on the
discussions presented below.
a. Claims-Based and Outcome Quality Measure Development for Future
Years
As part of Meaningful Measures initiative, we seek to develop
claims-based and outcome measures as part of the future for the HQRP.
While we acknowledge that there are limitations of using claims data as
a source for measure development, there are several advantages to using
claims data as part of a robust hospice quality reporting program.
Claims-based measures place minimal burden on providers, as they do not
require additional data collection and data submission. Furthermore, in
contrast to self-reported data that are dependent on hospice, patient,
or caregiver participation, claims data has the benefit of following a
relatively consistent format and of using a standard set of pre-
established codes that describe specific diagnoses, procedures, and
drugs. Additionally, nearly every encounter that a patient has with the
healthcare system leads to the generation of a claim, creating an
abundant and standardized source of patient information. This makes
claims data widely available, relatively inexpensive, and amenable to
analysis because they are readily available in an electronic format.
Medicare is the largest payer of hospice services and Medicare-
certified providers predominate in hospice so it makes good sense to
use claims data to reflect hospice care. Further, other settings'
quality reporting programs, such as the Inpatient Quality Reporting
Program (QRP) and the post-acute care (PAC) QRPs, have adopted claims-
based measures. The NQF has endorsed claims-based measures and believes
they can capture quality even when not directly assessing clinical
care. Although claims data have some limitations, such as incomplete
reflection of care processes and patient outcomes, they will continue
to be a valuable and important source of data for quality reporting for
a selected set of metrics and as part of a hospice quality reporting
program that includes other measures, such as HIS and CAHPS[supreg]
Hospice Survey.
While not mutually exclusive of claims-based measures, we also seek
to develop outcome measures as part of the Meaningful Measures
initiative. Outcome measures could help with improving pain management
and symptom management, which are core to hospice care. They could also
help identify the value of different staff providing care at different
times in hospice. For these reasons, we plan to explore the development
of other claims-based and outcome measures for the HQRP to work toward
the high priority areas of reducing regulatory burden and identifying
gaps in care. In identifying high priority areas for future measure
enhancement and development, CMS takes into consideration input from
all stakeholders including; Measures Application Partnership (MAP); the
Office of the Inspector General (OIG); the Medicare Payment Advisory
Commission (MedPAC); Technical Expert Panels (TEP); issues raised
through the Beneficiary and Family-Centered Care Quality Improvement
Organization; and national priorities, such as those established by the
National Priorities Partnership, the HHS Strategic Plan, the National
Strategy for Quality Improvement in Healthcare, the CMS Quality
Strategy, the Meaningful Measures initiative and the general public,
such as through rulemaking. In addition, CMS considers feedback and
input from published research and reports. We did not propose any new
claims-based or outcome measures at this time. However, we solicited
public comments and suggestions related to ideas for future claims-
based and outcome measure concepts and quality measures in the HQRP
that could also be tied to the goals of the Meaningful Measures
initiative.
A summary of the comments received regarding the future claims-
based and outcome measure concepts and our responses to those comments
appear below:
Comment: Several commenters support CMS efforts to develop outcome
measures for hospice care. Additionally, many commenters support using
claims data to develop new measures and cited the importance of a
balanced measure portfolio comprising different measure types and data
sources. We also received many comments in support of using data from
the hospice assessment tool under development to create new patient and
family outcome measures. Several commenters noted concerns about using
claims data for quality measurement. Specifically the commenters noted
that claims data only capture processes and not outcomes of patient
care, and some commenters stated that the number of visits was not a
good indicator of care quality. Commenters also stated that claims do
not reflect the full scope of hospice experience because not all
disciplines of the hospice team, such as volunteers or spiritual staff,
are captured on a claim. Several commenters stated that claims data do
not provide sufficient information to adequately represent hospice
practice. Additionally, some commenters recommended that CMS modify
hospice claims to capture information on all hospice disciplines such
as chaplain visits.
Response: We appreciate the commenters' support for outcome measure
development and reiterate our commitment to measuring outcomes as part
of the Meaningful Measures Initiative. We also appreciate the support
for using a future hospice assessment tool to develop additional
quality measures. We will take these recommendations under
consideration as we pursue new measure development.
Regarding the limited focus of claims data, we refer readers to our
discussion in the FY 2016 Hospice Wage Index and Payment Rate Update
final rule (80 FR 47189) where we address those concerns regarding
claims-based measures. As previously noted, claims-based measures place
minimal burden on providers, as they do not require additional data
collection and data submission, and follow a relatively consistent
format, using standardized and established coding. Claims-based
measures would be only one type of
[[Page 38523]]
quality measure in the QRP. This is in line with our efforts to create
a broader set of quality measurement that include outcome and claims-
based measures, since currently we report measures based on HIS and
CAHPS[supreg] Hospice data that are process and outcome measures. We
will take these comments into consideration as we continue to address
the high priority areas of identifying gaps in care and reducing
regulatory burden as we explore the development of other claims-based
and outcome measures for the HQRP.
b. Update on Claims-Based Measure Development
The FY 2018 Hospice Wage Index and Payment Rate Update and Hospice
Quality Reporting Requirements, (82 FR 36638), noted that, based on
input from stakeholders, CMS has identified two ``high priority'' areas
that will be addressed by claims-based measure development: Potentially
avoidable hospice care transitions and access to levels of hospice
care. The potentially avoidable hospice care transitions concept was
developed as a measure under consideration called ``Transitions from
Hospice Care, Followed by Death or Acute Care.'' The goal of this
measure is to identify hospices that have notably higher rates of live
discharges followed shortly by death or acute care utilization, when
compared to their peers. Details about this measure can be found in the
FY 2017 Hospice Wage Index and Payment Rate Update and the NQF website,
https://www.qualityforum.org/map/, where it went on the measures under
consideration (MUC) list in July 2018 and was reviewed by the MAP in
December 2018. At this time, we are revisiting the subject of
potentially avoidable hospice care transitions. While the MAP did not
support the measure as specified, MAP recognized the impact that care
transitions at the end of life can have on patients and suggested a
number of ways the MAP's concerns with the measure could be mitigated.
Areas that the MAP recommended included reconsidering the exclusion
criteria for the measure. Specifically, they recommended that we review
the exclusion for Medicare Advantage patients, as this may be excluding
too many patients. Additionally, the MAP suggested adding an exclusion
to allow for patient choice, as there are a number of reasons a patient
may choose to transition from hospice. For example, a patient may
choose to pursue additional curative treatment, have cultural beliefs
that influence the definition of a good death, have limited access to
primary care, or may need to revoke the hospice benefit to avoid a
financial penalty for seeking more acute care. MAP also noted that the
measure may provide more useful information if it separates out the
concepts addressed in the measure, as the measure may be trying to
address different concepts by including both death within 30 days and
admission to an acute care use within 7 days. The MAP also requested
that we consider shortening the timeframe for the measure (MAP 2019,
``Considerations for Implementing Measures in Federal Programs: Post-
Acute Care and Long-Term Care, Final Report'' February 15, 2019,
https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=89400). The access to levels of
hospice care measure concept is also detailed in the FY 2018 Hospice
Wage Index and Payment Rate Update. After further analyses, it was
determined that this measure concept as currently specified could
result in hospices providing higher levels of care when it is not
required by the plan of care or expected by CMS. We remain committed to
developing claims-based measures that meet high priority areas and are
rethinking both measures based on feedback from the MAP and our
analyses. We solicited public comments on ways to further develop these
two measure concepts and different measure concepts that fall under
these high priority areas. A summary of those comments and our
responses to the comments appear below:
While commenters supported measuring potentially-avoidable
transitions and access to levels of care and agreed that these are high
priority areas, they had several concerns and suggested modifying the
measures, requested more detail and encouraged CMS to consider the
feedback and recommendations from the National Quality Forum's MAP in
2018 for modifying the measure specifications. They also recommended
more measure testing in the measure development to help gain further
support for these measures.
Comment: Several commenters noted concerns about how a hospice
transitions measure would capture patient and family choices to revoke
hospice in favor of other types of treatment or access to additional
services. They recommended excluding from the measure live discharges
when the patient elects a different hospice provider or is discharged
for cause, and noted that patients' decisions to seek acute care is
outside of a hospice provider's control. Some commenters recommended
that claims data capture the reasons for a live discharge, noting there
could be many different ones. Several commenters recommended the
measure be simplified by separating into two separate measures, as it
is addressing different concepts by including both death within 30 days
and admission to an acute care use within 7 days. They also recommended
shortening the measurement period to create a stronger nexus between
the hospice stay and the adverse event.
Comment: Several commenters noted that claims data do not
sufficiently reflect the factors that determine appropriate provision
of the various levels of hospice care and that patient and caregiver
needs vary greatly. They noted that claims only indicate if the hospice
has billed one of the four levels of care. They further noted that
patient needs vary and the acuity information need to evaluate
appropriate GIP and CHC utilization is not available in claims data.
Commenters recommended looking at interdependent patterns of care and
monitoring for unintended consequences, such as providing higher levels
of care than needed.
Response: CMS appreciates the comments and the support for
continuing to refine efforts to measure these two high priority
concepts identified by the OIG in its 2018 report, entitled
``Vulnerabilities in the Medicare Hospice Program Affect Quality Care
and Program Integrity: An OIG Portfolio'' and available at https://oig.hhs.gov/oei/reports/oei-02-16-00570.asp. We will take these
comments under advisement as we continue exploring options for
measuring these constructs and reiterate our commitment to working with
NQF and the MAP. With respect to potentially-avoidable transitions, we
are carefully considering stakeholder and MAP feedback, and are looking
at multiple ways to measure this construct, including separating out
the components to reduce the measure's complexity. In our ongoing
development efforts we are examining the potential impact of these
measures, including any unintended consequences.
c. Update on the Hospice Assessment Tool
We discussed the plan to develop a hospice assessment tool in the
FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality
Reporting Requirements, (82 FR 36638). A technical expert panel on
development of such an assessment tool was held in October 2017
followed by a pilot study that began with training 9 hospice sites in
December 2017. We are sincerely thankful for and appreciative of the 9
[[Page 38524]]
Medicare hospices that participated in the pilot study. We learned much
from them during the pilot study and afterwards in lessons learned
interviews. Information from that pilot study, referred to as Pilot A,
can be found on the HQRP website at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/HEART.html. We also discussed Pilot A findings, lessons
learned, and goals of a hospice assessment tool at the September 2018
special open door forum (SODF). The transcript for that SODF can be
found at https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.html. Key concepts in developing a
hospice assessment tool include understanding the care needs of people
through the dying process and ensuring the safety and comfort of
individuals enrolled in hospice institutions nationwide. Currently,
admission and discharge data from HIS are used to calculate measures in
the HQRP. We would like to replace HIS and capture data with a hospice
assessment instrument in order to develop quality measures and any
possible future payment considerations to include bridging the gap to
achieve a fuller understanding of patient care needs. While it must be
recognized that hospice care differs from other PAC settings, there is
a need to create a comprehensive assessment instrument for hospice care
to align with other PAC settings, where feasible and practical. As
such, objectives of a comprehensive assessment instrument must include
the ability to establish goals of care that embrace the individual's
values and preferences, and are consistent with a person-centered
approach that values the person and caregiver in the care continuum
with an emphasis on physical, psychosocial, spiritual, and emotional
support. We continue our commitment to engaging stakeholders at regular
SODF meetings and other means like the HQRP website, open door forums
(ODF), webinars, and other sub-regulatory means.
One of the requests raised at the September 2018 SODF was to change
the name of the hospice assessment tool from Hospice Evaluation
Assessment Reporting Tool (HEART) to a name that is not as easily
confused with other HQRP related tools like the Hospice Abstraction
Reporting Tool (HART). We agree with this feedback since people refer
to both by their same sounding acronyms and solicited public comments
on the name for the hospice assessment tool.
We will keep providers informed about future measure and assessment
tool development efforts and solicit key stakeholder input through
regular sub-regulatory channels. Additionally, future measure concepts
under development, including details regarding measure definitions,
data sources, data collection approaches, and timeline for
implementation will be communicated in future rulemaking.
Comment: We received several comments expressing strong support for
the development a new assessment tool for use in conducting patient
assessments in real-time to assist in the plan of care and also for
developing future measures to benefit hospice providers and consumers.
These commenters also appreciated our ongoing and regular engagement of
stakeholders via sub-regulatory means in the development process.
Commenters also expressed support for changing the name and acronym
of an assessment tool, to avoid confusion. Commenters offered the
following suggestions: Hospice Comprehensive Assessment Tool or the
Comprehensive Assessment Tool for Hospice; Hospice Outcomes & Patient
Evaluation (HOPE); Hospice Care Assessment Tool; Hospice Assessment
Tool (HAT); and Evaluation and Assessment Reporting Tool for Hospice
(EARTH). One commenter recommended rather than renaming the HEART
(Hospice Evaluation Assessment Reporting Tool), CMS rename the Hospice
Abstraction Reporting Tool (HART) to the Hospice Assessment Software
Tool (HAST).
Response: We appreciate the support for and feedback on developing
a new hospice assessment. We are continuing the process of developing a
new hospice assessment that meets the objectives of patient-centered
care. This process includes additional information gathering, including
review of feedback on the HEART tool, and stakeholder engagement to
develop a draft instrument for alpha testing that will ultimately
support a national beta test. We intend to use rule-making to propose a
timeline and process for implementing the final, tested assessment
tool. We appreciate the support for wanting to use a new assessment to
development outcome measures and reiterate our commitment to providing
updates and engaging stakeholders through sub-regulatory means.
While HIS is a standardized mechanism for extracting medical record
data, it is not a patient assessment instrument that can capture
patient data in real time for use in care planning. Our goal for a
hospice assessment tool is to be more comprehensive than the HIS by
capturing care needs in real-time and throughout the end of life; not
just at admission and discharge. This includes flexibility to
accommodate patients with varying lengths of stay. In addition, a
comprehensive assessment tool will provide standardized data as all
Medicare-certified hospices will be collecting the same data in
standardized manner. By aligning the assessment with regular patient
care, we intend to capture baseline data to support care planning and
to inform quality measurement for the Hospice QRP, including outcome
measures, and to support providers' quality improvement efforts. A new
hospice assessment tool is intended to support quality measure
development and care planning. We intend to offer training and other
supports as the new tool is being prepared for implementation; the
timeline for roll-out will be established through rule-making.
We also appreciate commenter's support for changing the name of the
assessment under development. After reviewing the many great
suggestions, we like the name, Hospice Outcomes & Patient Evaluation
(HOPE). Both the full name and acronym, HOPE, captures our goals for
this assessment tool. It is a patient evaluation for use by hospices
and enables CMS to develop outcome measures that will help consumers in
selecting hospices when publicly reported. The acronym, HOPE, also
provides the sentiment of hope for patients achieving the quality of
life per their goals and wishes and supported by the hospice.
Final Decision: After considering the comments received in response
to the proposed rule and for the reasons discussed above, we are
finalizing our proposal to call the hospice assessment tool the Hospice
Outcomes & Patient Evaluation (HOPE).
3. 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
requires that beginning with the FY 2014 and for 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 for that FY.
[[Page 38525]]
b. Update on the CMS System for Reporting Quality Measures and
Standardized Patient Assessment Data and Associated Procedural Issues
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. We will be migrating to a new
internet Quality Improvement and Evaluation System (iQIES) as soon as
FY 2020 that will enable us to make real-time upgrades, and we are
designating that system as the data submission system for the Hospice
QRP. Effective October 1, 2019, we will notify the public of any
changes to the CMS-designated system in the future using sub-regulatory
mechanisms such as web page postings, listserv messaging, and webinars.
We solicited public comment on the iQIES and received no comments.
Final Decision: For the reasons discussed in the above paragraph,
we will be migrating to the iQIES system as soon as FY 2020 and will
provide further information regarding the migration and any future
system of record changes via sub-regulatory mechanisms to make this
transition as smooth as possible.
4. CAHPS[supreg] Hospice Survey Participation Requirements for the FY
2023 APU and Subsequent Years
a. Background and Description of the CAHPS[supreg] Hospice Survey
The CAHPS[supreg] 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[supreg] 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[supreg] Hospice Survey Measures
The CAHPS[supreg] Hospice Survey measures received NQF endorsement
on October 26th, 2016 (NQF #2651). We adopted these 8 survey based
measures for the CY 2018 data collection period and for subsequent
years. These 8 measures are publicly reported on a designated CMS
website that is currently Hospice Compare.
c. Data Sources
We previously finalized the participation requirements for the FY
2020, FY 2021, and FY 2022 APUs (see 82 FR 36673). We proposed to
extend the same participation requirements for the HQRP for FY 2023 and
all future years. As part of the Patients Over Paperwork initiative, we
solicited comments about the CAHPS[supreg] Hospice Survey
questionnaire. We solicited comments regarding suggested changes,
additions or deletions to the instrument that would improve its value
to hospices for quality improvement and consumers for selecting a
hospice.
A summary of those comments and our responses to them appear below:
Comment: Some commenters suggested that the survey was too long,
too complex and duplicative. Other commenters stated that the language
could be ``friendlier,'' that the setting of the patient's death should
determine the survey questions asked, and that the survey should be
offered in a web-based version.
Response: We are currently exploring ways to simplify and shorten
the survey and we are examining the feasibility of using web-based data
collection in conjunction with traditional survey methods. In addition,
we had a literacy-level review of the questionnaire and are reviewing
what changes may be feasible to make. When we designed the survey, we
considered allowing the setting of the patient's death to determine the
questions. However, the results from testing showed this would be
burdensome to patients, hospices and vendors and determined a single
survey would be easier to administer.
Comment: Some commenters requested changes to the timing of data
collection. Most of the commenters suggested that we should start data
collection sooner after the death, 45 days instead of a lag of 2
months.
Response: In the initial development of the survey, the original
timeframe for sending out the survey was trying to balance respecting
the difficult time the loved one was going through following the death
and not waiting too long after the hospice services were provided. We
will take this into consideration as we consider potential changes to
the survey.
Comment: Some commenters stated that patients' families do not make
a distinction between the hospice staff and nursing home/assistance
living facility staff when responding to the questionnaire.
Response: To help the respondent make these distinctions, we
include specific references to the hospice involved as part of the mail
questionnaire and the telephone questionnaire script.
Comment: Several commenters requested a variety of different
wording changes to the questionnaire, including changes to the response
options and the addition of ``not applicable'' as a response. Some
commenters stated that the hospice logo should be included in mailing
packages.
Response: During survey development we conducted extensive
cognitive interviews with potential respondents to see if they could
understand the response scales. The respondents had no problems
understanding or using our response options. We do not need to include
``not applicable'' as a response option because we provide instructions
for skipping inapplicable items. We do allow hospice logos to be placed
on the questionnaire for mail surveys. Please refer to the Quality
Assurance Guidelines Manual on the survey website
(www.hospicecahpssurvey.org).
Comment: Some commenters suggested changes to the survey
exclusions, in particular the exclusion of patients who have been in
hospice less than 48 hours when they died. In addition, several
commenters stated that we should ``give credit'' for the response of
``usually,'' as there may be persons who are uncomfortable with
absolutes such as ``always.'' A few commenters suggested the inclusion
of questions specifically about veterans and to use ethnicity as a
case-mix adjustment factor.
Response: The reason we excluded patients who die within 48 hours
is because we were concerned that caregivers did not have enough
experience with the hospice to provide informed responses to the
survey. We do publicly report the results including responses of
``usually''. We determined that we would not require the inclusion of
questions specifically about veterans because it would make the survey
even longer. We also note that among our case-mix adjustments are
variables for the language in which the survey was administered, along
with the language the caregiver reports speaking at home. The goal of
case-mix adjustment is to adjust for differences in patient or
caregiver characteristics that impact response tendencies. We generally
do not adjust for race and ethnicity in order to not mask true
differences in the quality of care across racial and ethnic groups.
Comment: Several commenters stated that we should take into
consideration hospice characteristics, including rural versus urban,
and hospice size.
[[Page 38526]]
Response: We publicly report hospice size. We consider a variety of
variables, including urban and rural characteristics, when looking at
quality measures. Internal analysis of our data shows that
approximately eight in ten hospices that report CAHPS data are urban
and about two in ten are rural. Please note that rural hospices may be
more likely to qualify for size exemptions and therefore may not
participate in the CAHPS[supreg] Hospice Survey.
Final Decision: We appreciate the feedback on potential changes to
the CAHPS[supreg] Hospice Survey and will take these comments into
consideration as we consider changes. Any potential changes will be
proposed through future rulemaking.
d. Public Reporting of CAHPS[supreg] Hospice Survey Results
We began public reporting of the results of the CAHPS[supreg]
Hospice Survey on Hospice Compare as of February 2018. We report 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. We refresh the
data 4 times a year in the months of February, May, August, and
November.
e. Volume-Based Exemption for CAHPS[supreg] Hospice Survey Data
Collection and Reporting Requirements
We previously finalized a volume-based exemption for CAHPS[supreg]
Hospice Survey Data Collection and Reporting requirements in the FY
2017 Hospice Wage Index and Payment Rate Update final rule (82 FR
36671). We proposed to continue our policy for a volume-based exemption
for CAHPS[supreg] Hospice Survey Data Collection for FY 2021 and every
year thereafter. For example, for the FY 2021 APU, hospices that have
fewer than 50 survey-eligible decedents or caregivers in the period
from January 1, 2018 through December 31, 2018 (reference year) are
eligible to apply for an exemption from CAHPS[supreg] Hospice Survey
data collection and reporting requirements (corresponds to the CY 2019
data collection period). To qualify, hospices must submit an exemption
request form for the FY 2021 APU. The exemption request form is
available on the official CAHPS[supreg] Hospice Survey website: https://www.hospiceCAHPSsurvey.org. Hospices that intend to claim the size
exemption are required to submit to CMS their completed exemption
request form covering their total unique patient count for the
reference year (for the CY 2019 data collection period the reference
year is January 1, 2018 through December 31, 2018). The due date for
submitting the exemption request form for the FY 2021 APU is December
31, 2019. Exemptions for size are active for 1 year only. If a hospice
continues to meet the eligibility requirements for this exemption in
future FY APU periods, the organization needs to request the exemption
annually for every applicable FY APU period by the final day of the
calendar year. Subsequent periods will follow the same pattern of using
the year before the data collection year as the reference year for
determining eligibility.
Starting with FY 2022, we proposed to provide an automatic
exemption to any hospice that (1) is an active agency and (2) according
to CMS data sources has served less than a total of 50 unique decedents
in the reference year. The automatic exemption is good for 1 year and
will be reassessed in subsequent years. Hospices with fewer than 50
unique decedents in the reference year would not be required to submit
an exemption request form.
Hospices that have a total patient count of more than 50 unique
decedents in the reference year, but that have a total of fewer than 50
survey-eligible decedent/caregiver pairs, will not be granted an
automatic exemption. However, hospices may qualify to apply for a size
exemption if they have fewer than 50 survey-eligible decedent/caregiver
pairs (for example, if a patient dies in hospice care less than 48
hours after admission, they and their caregiver is not considered to be
survey-eligible). Similarly, if a caregiver has an address outside the
United States (U.S.) and its possessions, then that decedent/caregiver
pair is not survey-eligible. Hospices may apply for a size exemption by
submitting the size exemption request form as outlined above. This
exemption is valid for 1 year only. If the hospice remains eligible for
the size exemption, it must request the exemption annually for every
applicable FY APU period. We solicited feedback on these proposals.
Table 14--Size Exemption Key Dates FY 2021 Through FY 2025
----------------------------------------------------------------------------------------------------------------
Data
Fiscal year collection Reference year Size exemption form submission deadline
year
----------------------------------------------------------------------------------------------------------------
FY 2021................................ 2019 2018 December 31, 2019.
FY 2022................................ 2020 2019 December 31, 2020.
FY 2023................................ 2021 2020 December 31, 2021.
FY 2024................................ 2022 2021 December 31, 2022.
FY 2025................................ 2023 2022 December 31, 2023.
----------------------------------------------------------------------------------------------------------------
f. Newness Exemption for CAHPS[supreg] Hospice Survey Data Collection
and 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, FY 2024, FY 2025, and all
future years. We encourage hospices to keep the letter they receive
providing them with their 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 proposed to continue those requirements in all
subsequent years. Below we reprint the Hospice Survey data submission
dates finalized in the FY 2019 Hospice Wage Index and Payment Rate
Update final rule (83 FR 38643).
[[Page 38527]]
Table 15--CAHPS[supreg] Hospice Survey Data Submission Dates for the APU
in FY 2023, FY 2024, and FY 2025
------------------------------------------------------------------------
CAHPS[supreg] quarterly data
Sample months (month of death) * submission deadlines **
------------------------------------------------------------------------
FY 2023 APU
------------------------------------------------------------------------
CY January-March 2021 (Quarter 1)... August 11, 2021.
CY April-June 2021 (Quarter 2)...... November 10, 2021.
CY July-September 2021 (Quarter 3).. February 9, 2022.
CY October-December 2021 (Quarter 4) May 11, 2022.
------------------------------------------------------------------------
FY 2024 APU
------------------------------------------------------------------------
CY January-March 2022 (Quarter 1)... August 10, 2022.
CY April-June 2022 (Quarter 2)...... November 9, 2022.
CY July-September 2022 (Quarter 3).. February 8, 2023.
CY October-December 2022 (Quarter 4) May 10, 2023.
------------------------------------------------------------------------
FY 2025 APU
------------------------------------------------------------------------
CY January-March 2023 (Quarter 1)... August 9, 2023.
CY April-June 2023 (Quarter 2)...... November 8, 2023.
CY July-September 2023 (Quarter 3).. February 14, 2024.
CY October-December 2023 (Quarter 4) May 80, 2024.
------------------------------------------------------------------------
* Data collection for each sample month initiates 2 months following the
month of patient death (for example, in April for deaths occurring in
January).
** Data submission deadlines are the second Wednesday of the submission
months, which are the months August, November, February, and May.
For further information about the CAHPS[supreg] Hospice Survey, we
encourage hospices and other entities to visit: https://www.hospiceCAHPSsurvey.org. For direct questions, contact the
CAHPS[supreg] Hospice Survey Team at [email protected] or
call 1 (844) 472-4621.
5. 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 a
hospice has the opportunity to review the data that is to be made
public prior to such data being made public; the data will be available
on our public website. To meet the Act's requirement for making quality
measure data public, we launched the Hospice Compare website 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. Since its release, the CMS
Hospice Compare website has reported 7 HIS Measures (NQF #1641, NQF
#1647, NQF #1634, NQF #1637, NQF #1639, NQF #1638, and NQF #1617). In
February 2018, CAHPS[supreg] Hospice Survey measures (NQF #2651) were
added to the website, and in November 2018, the Hospice and Palliative
Care Composite Process Measure--Comprehensive Assessment at Admission
(NQF #3235) was added to the website; please see the following rules
where these topics were discussed, FY 2016 Hospice Wage Index and
Payment Rate Update (80 FR 47199); FY 2017 Hospice Wage Index and
Payment Rate Update (81 FR 52184); FY 2018 Hospice Wage Index and
Payment Rate Update (82 FR 36675); and FY 2019 Hospice Wage Index and
Payment Rate Update (83 FR 38640).
b. Update to ``Hospice Visits when Death is Imminent'' Measure To Be
Publicly Displayed in August 2019
1. Background and Description of ``Hospice Visits when Death is
Imminent'' Measure Pair
In the FY 2017 Hospice Wage Index and Payment Rate Update (81 FR
52163 to 52169, August 6, 2016), we finalized the ``Hospice Visits when
Death is Imminent'' measure pair for implementation April 1, 2017. This
measure pair assesses whether the needs of hospice patients and their
caregivers were addressed by the hospice staff during the last days of
life. The ``Hospice Visits when Death is Imminent'' measure pair is
made up of two measures, Measure 1 and Measure 2. Measure 1 of the pair
assesses the percentage of patients receiving at least 1 visit from a
registered nurse, physician, nurse practitioner, or physician assistant
in the last 3 days of life. Measure 2 assesses the percentage of
patients receiving at least 2 visits from social workers, chaplains or
spiritual counselors, licensed practical nurses, or aides in the last 7
days of life.
2. Update to Public Reporting of the ``Hospice Visits when Death is
Imminent'' Measure Pair
As stated in the FY 2019 Hospice Wage Index and Payment Rate Update
and Hospice Quality Reporting Requirements (83 FR 38643 through 38645,
August 6, 2018), quality measures are publicly reported on Hospice
Compare or other CMS websites once they meet the readiness standards
for public reporting, which is determined through rigorous testing for
reliability, validity, and reportability. Since the proposal of the
``Hospice Visits when Death is Imminent'' measure pair, we have
conducted further measure testing activities according to NQF
guidelines and the Blueprint for the CMS Measures Management System
Version 14.0 available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/BlueprintVer14.pdf. This testing is conducted to ensure that measures
demonstrate scientific acceptability (including reliability and
validity) and meet the goals of the HQRP, which include distinguishing
performance among hospices and contributing to better patient outcomes.
As we assessed the scientific acceptability of ``Hospice Visits
when Death is Imminent'' measure pair, we determined that Measure 1
meets established standards for reliability,
[[Page 38528]]
validity, and reportability. Therefore, the measure is being publicly
reported as stated in the FY 2019 Hospice Wage Index and Payment Rate
Update and Hospice Quality Reporting Requirements (83 FR 38645 through
38648). Our testing of Measure 2 of the ``Hospice Visits when Death is
Imminent'' measure pair (referred to as Measure 2) revealed that the
measure did not meet readiness standards for public reporting and
additional testing was needed before we could make a decision on the
public reporting of Measure 2. Therefore, we decided not to publish
Measure 2 of the ``Hospice Visits when Death is Imminent'' measure
pair. See our discussion on our website: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Public-Reporting-Background-and-Announcements.html for more
information.
Although Measure 2 will not be publicly reported, we believe that
Measure 2 focuses on an important aspect of quality care for imminently
dying patients. Therefore, we will include quality performance data on
the measure in each hospice's confidential Quality Measure Reports and
the Review and Correct Report available on the Certification and Survey
Provider Enhanced Reporting (CASPER) system. Hospices will also still
receive credit for reporting on Measure 2 as part of the HQRP
requirements. Furthermore, Measure 2 aligns with our Meaningful
Measures initiative and its quality priorities, particularly
``Strengthen Person and Family Engagement as Partners in Their Care--
End of Life Care according to Preferences.'' While Measure 1 of the
``Hospice Visits when Death is Imminent'' measure pair (referred to as
Measure 1) addresses case management and clinical care, Measure 2,
which includes visits from social workers, chaplains or spiritual
counselors, licensed practical nurses, and aides, recognizes providers'
flexibility to provide individualized care from a variety of
disciplines that is in line with the patient, family, and caregiver's
preferences and goals for care and contributes to the overall well-
being of the individual and others important to them at the end of
life. As such, we believe that Measure 2 addresses a high-priority
measure area where there is significant opportunity for improvement, as
well as is meaningful to patients, clinicians, and providers alike.
We will conduct additional testing on Measure 2 to determine if and
how the measure specifications may be modified or re-specified, and if
the method for displaying the measure may be adjusted, so that this
measure meets the highest standards of scientific acceptability and
reportability. Additional testing will also ensure that Measure 2 is
thoroughly evaluated to determine that it meets the criteria for public
reporting.
The results of the additional testing will inform the next steps
regarding the public reporting of Measure 2 of ``Hospice Visits when
Death is Imminent'' measure pair. As stated in the FY 2019 Hospice Wage
Index and Payment Rate Update and Hospice Quality Reporting
Requirements (83 FR 38643), we will inform providers of updates to
testing and public reporting of quality measures, including Measure 2
of the ``Hospice Visits when Death is Imminent'' measure pair, through
sub-regulatory channels and regular HQRP communication strategies, such
as Open Door Forums, Medicare Learning Network, CMS.gov website
announcements, listserv messaging, and other opportunities. We will
announce any policy changes through the notice and comment rulemaking
process.
Our decision not to publicly report Measure 2 of the ``Hospice
Visits when Death is Imminent'' measure pair at this time is distinct
from our interest in continuing collecting these data. Specifically,
these data are needed to determine whether a measure meets all the
criteria for public reporting. Continued data collection will enable us
to test and modify or re-specify a measure so that these criteria are
satisfied. We seek to balance these data collection effort with the
section 1814(i)(5)(E) of the Act, which states, ``The Secretary shall
report quality measures that relate to hospice care provided by hospice
programs on the internet website of the Centers for Medicare & Medicaid
Services.'' We believe that information required for the robust
analyses to further develop this measure, modify or re-specify it to
allow for public reporting justifies continuing data collection.
The data collection and submission requirements for the ``Hospice
Visits When Death is Imminent'' measure pair will not change in order
to collect the data for measure 1, which will be publicly reported
beginning with FY 2019. Measure 2, which will not be publicly reported
at this time, needs to be further evaluated for modification or re-
specification. Measure 2 of ``Hospice Visits when Death is Imminent''
measure pair is calculated using items O5010, O5020 and O5030 from the
HIS V2.00.0. These items collect data on hospice visits in the final 3
days of life, level of care in the final 7 days of life, and hospice
visits in the three to six days prior to death. Because the measure is
not being removed from the HQRP, providers should continue to complete
these items accurately and completely and submit HIS records to us in a
timely manner. We require data from Section O to calculate Hospice
Visits when Death is Imminent Measure 1, which will be publicly
reported beginning in August 2019. Therefore, we proposed continued
collection of this data to complete additional testing and to make a
determination about the public reporting of Measure 2 of the ``Hospice
Visits when Death is Imminent'' measure pair. We expect to complete our
analysis by the end of FY 2020, and determine next steps for public
reporting based on meeting established standards for reliability,
validity, and reportability.
We are cognizant and respectful of the time and effort that
hospices take to complete the HIS V2.00.0 items used to calculate and
test Measure 2. We will continually evaluate the volume and robustness
of the resulting data to determine when data collection is no longer
required.
Comments: We received support from several commenters for our
proposal to continue data collection of relevant data to support
testing through September 30, 2020. We also received support for
continued testing of Measure 2 of the ``Hospice Visits when Death is
Imminent'' measure pair to evaluate if it should be publicly-reported.
Some commenters also confirmed the value of visit information for
quality purposes. In addition, commenters provided suggestions for
modifying Measure 2. These included addressing higher levels of care
and short lengths of stay, including RN visits in the definition, and
capturing whether patients and their families declined a visit during
the last days of life, potentially through skip logic. Some commenters
stated that Measure 1 and Measure 2 were paired metrics that should be
reported together. A few commenters noted location of care and rural
versus urban settings as factors that could affect measure results.
Response: We appreciate the commenters' feedback and support for
our plans to continue data collection and testing to assess options for
assuring this measure meets the highest standards of scientific
acceptability and reportability for public reporting. We intend to
consider commenters' specific suggestions during our testing process
for this quality measure. We note that we do include urban and rural
issues and location of care as we develop, modify, or re-specify this
and other measures. Overall, we have found that
[[Page 38529]]
there is no statistical difference between the visits in urban versus
rural locations and this is further supported by the literature \39\
that supports this position.
---------------------------------------------------------------------------
\39\ Teno JM, Plotzke M, Christian T, Gozalo P. Examining
Variation in Hospice Visits by Professional Staff in the Last 2 Days
of Life. JAMA Intern Med. 2016;176(3):364-370. doi:10.1001/
jamainternmed.2015.7479
---------------------------------------------------------------------------
The two visit measures are referred to as paired because they
relate to the same topic of measuring visits in the last days of life
by hospice disciplines. However, the measures are independent
constructs and can be reported separately. The measures are each
developed using different number of visits and different hospice
disciplines. They are unique measures that each provide useful and
distinct information for separate public reporting.
Final Decision: After considering the comments received in response
to the proposed rule and for the reasons discussed in the above
paragraph, we are finalizing our proposal to continue collection of
this data to complete additional testing and to make a determination
about the public reporting of Measure 2 of the ``Hospice Visits when
Death is Imminent'' measure pair. We expect to complete our analysis by
the end of FY 2020, and determine next steps for public reporting based
on meeting established standards for reliability, validity, and
reportability. We will continue to use a variety of sub-regulatory
channels and regular HQRP communication strategies, such as Open Door
Forums, Medicare Learning Network, CMS.gov website announcements,
listserv messaging, and other opportunities, to provide ongoing updates
of testing results and our plans for modifying and reporting this
measure.
c. Display of Publicly Available Government Data Along With CMS and
Medicare Hospice Related Data as Information for Public Reporting
1. Update To Posting of Public Use File (PUF) Data as Information for
Public Reporting
In the FY 2019 Hospice Wage Index and Payment Rate Update and
Hospice Quality Reporting Requirements (83 FR 38649), we finalized
plans to publicly post information from the Medicare Provider
Utilization and Payment Data: Physician and Other Supplier Public Use
File (PUF) and other publicly available CMS data to the Hospice Compare
or other CMS website. This PUF data, along with clear text explaining
the purpose and uses of this information and suggesting consumers
discuss this information with their healthcare provider, displayed
under a new section on Hospice Compare in May 2019. This new section
precede the existing ``Family Experience of Care'' section on the
Hospice Compare website. Tables 16 through 18 show how these data
displayed on Hospice Compare.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR06AU19.035
[[Page 38530]]
[GRAPHIC] [TIFF OMITTED] TR06AU19.036
[[Page 38531]]
[GRAPHIC] [TIFF OMITTED] TR06AU19.037
BILLING CODE 4120-01-C
2. Posting Information From Government Data Sources as Information for
Public Reporting
As part of our ongoing efforts to make public reporting more
meaningful and informative to our beneficiaries, their caregivers, and
families, we propose to publicly post information that utilizes
publicly available government data from other agencies, in addition to
the data from the PUF or other CMS or Medicare sources, at some time in
the future. We propose to use comparative and complementary data from
other government sources as part of public reporting on Hospice Compare
or other CMS websites in the future and as soon as FY 2020. Examples
include information compiled by the U.S. Census Bureau, Centers for
Disease Control and Prevention, Bureau of Labor Statistics, and
National Institutes of Health.
We may use information available in these public government files
to augment the section described above. This section including PUF data
and information from other public government data will provide
additional information along with the HQRP measures currently from the
HIS and CAHPS[supreg] quality measures that are already displayed.
Any future reporting of public government data as information for
public reporting will be displayed in a consumer-friendly format on
Hospice Compare or other CMS website. This means we may display the
data as shown in these publicly available government files or present
the data after additional calculations. For example, the data could be
averaged over multiple years, displayed as a percentage rather than the
raw number, or other calculations could be based on a given year or
over multiple years, so the data has meaning to end-users. Furthermore,
by performing these calculations, we can make the data apply to
hospices broadly regardless of size, location, or other factors.
Also, we would like to note that data used from these publicly
available sources are not quality measures. Rather, they present
supplementary information that many consumers seek during the provider
selection process and, therefore, will help them to make an informed
decision. This is similar to other useful information we already
publicly display under the Spotlight, Tools and Tips, and Additional
Information sections on the Hospice Compare homepage. Data from
publicly available data sources can serve as one more piece of
information, along with
[[Page 38532]]
quality of care metrics from the HIS and CAHPS[supreg] Hospice Survey
and other useful information, to help consumers effectively and
efficiently compare hospice providers and make an informed decision
about their care in a stressful time. We also believe such information
may be useful to providers. For example, adding data as information
from the U.S. Census Bureau in coordination with this service area from
Medicare claims data may help consumers better understand the service
area in which they are looking for services (for example, if there is a
large population of people from a similar race or ethnicity in the
area). This information may also help providers better understand their
service area to see if there are any business development opportunities
(for example, if there is a large population of a similar race or
ethnicity, the provider may consider investing resources in better
serving patients from this background).
To ensure that end-users understand that these data provide
information about hospice characteristics and are not a reflection of
the quality of care a hospice provides, we will, with consultation from
key stakeholders, carefully craft explanatory language to ensure that
consumers understand the information and how the data are meant for
informational purposes only.
As we determine which publicly available government data sources we
will use and how we will be using and presenting information from these
sources, we will inform the public and engage with stakeholders via
sub-regulatory processes, including regular HQRP communication
strategies such as Open Door Forums, Medicare Learning Network,
Spotlight Announcements, and other opportunities.
We solicited public comment on our proposal to post information
from publicly available government sources for public reporting in the
future.
A summary of those comments and our responses to them appear below:
Comment: Overall commenters supported publicly posting contextual
government information to supplement the already posted CMS and
Medicare public data, but several requested more detail on the specific
information for posting data from other U.S. government websites and
how it would be used. Some commenters recommended that there be a
correlation between any other U.S. government data and the quality of
hospice care or meaningful context of hospice and questioned the
sources noted. They also recommended seeking stakeholder input prior to
adding information for public reporting and making sure any posted
information was clearly explained.
Response: We appreciate the commenters' support and request for
more detail about any additional data from public other U.S. government
websites under consideration for posting publicly. We confirm our
commitment to using sub-regulatory processes for soliciting and
receiving ongoing stakeholder information and feedback as we develop
these data. As part of this effort, we will provide mock-ups of the
data for stakeholder feedback and show the relationship between the
data from other U.S. government websites and hospice related data. The
goal is for the information to help consumers in comparing providers.
We reiterate our intent to conduct plain language testing, including
distinguishing this information from quality data.
Final Decision: After considering the comments received in response
to the proposed rule and for the reasons discussed in the above
paragraph, we are finalizing our proposal to post information from
other publicly-available U.S. government sources to publicly report in
the future and as soon as FY 2020 on Hospice Compare or other CMS
website.
IV. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment before the provisions of a
rule take effect in accordance with section 553(b) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we can
waive this notice and comment procedure if the Secretary finds, for
good cause, that the notice and comment process is impracticable,
unnecessary, or contrary to the public interest, and incorporates a
statement of the finding and the reasons therefore in the rule. This
hospice proposed rule has previously been subjected to notice and
comment procedures. These corrections do not make substantive changes
to this policy. Specifically, we redesignated paragraphs (c) through
(f) as paragraphs (d) through (g). This redesignation would affect two
cross-references in Sec. 418.26(c) (2) and Sec. 418.28(c) (2). As a
result, we made conforming changes to accompany the redesignations in
Sec. 418.24. Likewise, at Sec. 418.3, we define the term BFCC-QIO as
the Beneficiary and Family Centered Care Quality Improvement
Organization. Because these conforming changes were not proposed in the
proposed rule, we are adopting them here under a ``good cause'' waiver
of proposed rulemaking. The specific changes we are making in the
regulations simply codify the final policies we described in the
proposed rule and do not reflect any additional substantive changes.
Therefore, we find that undertaking further notice and comment
procedures to incorporate these corrections into the final rule is
unnecessary and contrary to the public interest.
V. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
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.
Section 1814(i)(5)(C) of the Act requires that each hospice submit
data to the Secretary on quality measures specified by the Secretary.
This data must be submitted in a form and manner, and at a time
specified by the Secretary.
We solicited public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
A. Election Statement Addendum: ``Patient Notification of Hospice Non-
Covered Items, Services, and Drugs''
To calculate this burden estimate, we use salary information from
the Bureau of Labor Statistics (BLS) website at https://www.bls.gov/
and include a fringe benefits package worth 100 percent of the base
salary. The mean hourly wage rates are based on May, 2018 BLS data for
each discipline. Table 19 contains our burden estimate assumptions for
the proposed Election Statement Addendum: ``Patient Notification of
Hospice Non-Covered Items, Services, and Drugs'' discussed in section
III.C. of this final rule. The required addendum would not be required
until FY 2021; that is, the addendum would be required, upon
[[Page 38533]]
request, for those hospice elections beginning on or after October 1,
2020. This burden estimate represents what the estimated costs would be
if implemented in FY 2020. We will re-estimate this burden in the FY
2021 proposed rule using more recent claims data to more accurately
reflect costs for FY 2021 implementation. For the purposes of this
estimate, we are assuming that all beneficiaries electing the hospice
benefit, and who do not die within the first 5 days of care, would
request the addendum.
Table 19--Election Statement Addendum: ``Patient Notification of Hospice Non-Covered Items, Services, and
Drugs'' Burden Estimate Assumptions
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Number of Medicare-billing hospices, from FY 2017 4,465.
Medicare Enrollment Database, Provider of Service
files.
Number of hospice elections in FY 2017................ (1,268,497 x 0.72) = 913,318.
Hourly rate of an office employee (Executive $59.18 ($29.59 x 2.00).
Secretaries and Executive Administrative Assistants,
43-6011).
Hourly rate of an administrator (General and $119.12 ($59.56 x 2.00).
Operations Managers, 11-1021).
Hourly rate of registered nurses (Registered Nurses, $72.60 ($36.30 x 2.00).
29-1141).
Hourly rate of pharmacy technicians (Pharmacy $32.70 ($16.35 x 2.00).
Technicians, 29-2052).
----------------------------------------------------------------------------------------------------------------
Source: FY 2017 hospice claims data. 28 percent of beneficiaries die within the first 5 days of hospice care.
Hospices are exempt for completing addendum if beneficiary dies within first the first 5 days of care.
Section 1814(a) (7) of the Act requires for the first 90-day period
of a hospice election the individual's attending physician (as defined
in section 1861(dd)(3)(B) of the Act) (which for purposes of this
subparagraph does not include a nurse practitioner), and the medical
director (or physician member of the interdisciplinary group described
in section 1861(dd)(2)(B) of the Act) of the hospice program providing
(or arranging for) the care, each certify in writing, at the beginning
of the period, that the individual is terminally ill (as defined in
section 1861(dd)(3)(A) of the Act). The regulations codified at Sec.
418.22 and Sec. 418.25 provide the requirements regarding the
certification of terminal illness and admission to hospice care. The
hospice medical director must specify that the individual's prognosis
is for a life expectancy of 6 months or less if the terminal illness
runs its normal course. Additionally, clinical information and other
documentation that support the medical prognosis must accompany the
certification and must be filed in the medical record with the written
certification. The physician must include a brief narrative explanation
of the clinical findings that supports a life expectancy of 6 months or
less as part of the certification. The aforementioned regulations also
require that the hospice medical director must consider both related
and unrelated conditions and current clinically relevant information
when making the decision to certify the individual as terminally ill.
Likewise, the hospice CoPs at Sec. 418.102(b) provide the requirements
regarding the certification responsibility of the hospice medical
director or hospice physician designee which includes a review of the
clinical information, including both related and unrelated conditions,
for each hospice patient.
In order to receive hospice services under the Medicare hospice
benefit, eligible beneficiaries must elect to receive hospice care by
completing an election statement. By signing this election statement,
the individual acknowledges that he or she waives all rights to
Medicare payments for treatment related to the terminal illness and
related conditions. The content requirements for the hospice election
statement are listed at Sec. 418.24(b) and each hospice election
statement must include the following information:
(1) Identification of the particular hospice and of the attending
physician that will provide care to the individual. The individual or
representative must acknowledge that the identified attending physician
was his or her choice.
(2) The individual's or representative's acknowledgement that he or
she has been given a full understanding of the palliative rather than
curative nature of hospice care, as it relates to the individual's
terminal illness.
(3) Acknowledgement that certain Medicare services, as set forth in
Sec. 418.24(d) of this section, are waived by the election.
(4) The effective date of the election, which may be the first day
of hospice care or a later date, but may be no earlier than the date of
the election statement.
(5) The signature of the individual or representative.
Once a beneficiary is certified as terminally ill and elects the
Medicare hospice benefit, the hospice conducts an initial assessment
visit in advance of furnishing care. During this visit, the hospice
must provide the patient or representative with verbal and written
notice of the patient's rights and responsibilities as required by the
CoPs at Sec. 418.52. Likewise, the regulations at Sec. 476.78 state
that providers must inform Medicare beneficiaries at the time of
admission, in writing, that the care for which Medicare payment is
sought will be subject to Quality Improvement Organization (QIO)
review.
The beneficiary needs identified in the initial and comprehensive
assessments drive the development and revisions of an individualized
written plan of care for each patient as required by the hospice CoPs
at Sec. 418.56. The hospice plan of care is established, reviewed and
updated by the hospice IDG and must include all services necessary for
the palliation and management of the terminal illness and related
conditions. While needs unrelated to the terminal illness and related
conditions are not the responsibility of the hospice, the hospice may
choose to furnish services for those needs regardless of
responsibility. However, if a hospice does not choose to furnish
services for those needs unrelated to the terminal illness and related
conditions, the hospice is to communicate and coordinate with those
health care providers who are caring for the unrelated needs, as
described in Sec. 418.56(e). In accordance with the CoPs, the hospice
must document the services and treatments that address how they will
meet the patient and family-specific needs related to the terminal
illness and related conditions in the plan of care, and those needs
unrelated to the terminal illness and related conditions that are
present when the patient elects hospice should also be documented. This
documentation ensures that the hospice is aware of those unrelated
needs and who is addressing them. This documentation provides the
support for the hospices'
[[Page 38534]]
financial responsibility for the hospice services they will be
providing. There is limited beneficiary financial liability for hospice
services upon election of the Medicare hospice benefit. However, for
any services received that are unrelated to the terminal illness and
related conditions, the beneficiary would incur any associated
copayments and coinsurance.
Hospices already are required to review, determine, and document
information on unrelated conditions in accordance with the hospice
regulations and CoPs. However, to ensure Medicare beneficiaries are
provided disclosure of those conditions, items, services, and drugs the
hospice has determined to be unrelated to the terminal illness and
related conditions at the time of admission, we are finalizing
additions to the regulations at Sec. 418.24(b) and (c) for FY 2021,
which will require an election statement addendum titled ``Patient
Notification of Hospice Non-Covered Items, Services, and Drugs'' that
must be issued, on request, to the patient (or representative) within 5
days of the hospice election date to ensure that Medicare beneficiaries
are fully informed whether or not all items, services, and drugs
identified on the hospice plan of care will be furnished by the
hospice. The addendum statement would not be required if the
beneficiary died within 5 days of the hospice election date. This
addendum would accompany the hospice election statement and each
hospice would use the required proposed elements to develop and design
their own addendum to best meet their needs and the requirement. This
requirement for payment would be added to the regulations at Sec.
418.24(b) and (c) effective for hospice elections beginning on and
after October 1, 2020.
The burden associated with the documentation requirement for the
addendum includes the time for each hospice to develop the addendum
that the hospice provides to the beneficiary (or their representative)
within 5 days of election of the Medicare hospice benefit. The addendum
must include the name of the issuing hospice, beneficiary's name, and
hospice medical record identifier. The addendum must also allow the
hospice registered nurse to document a list of non-covered conditions
and associated items, services, and drugs, as well as provide a
clinical explanation as to why these conditions and associated items,
services, and drugs have been determined to be unrelated to the
terminal illness and related conditions. This documentation would
include references to any relevant clinical practice, policy, or
coverage guidelines. The addendum must include statements informing the
patient as to the purpose of the addendum and information on BFCC-QIO
Immediate Advocacy rights and contact information. The addendum would
be signed by the beneficiary as an acknowledgement that he or she has
received this information, but signing it does not mean the beneficiary
agrees with the determination. We believe that the burden for the
hospice associated with the election statements addendum would be the
cost of developing the form and the cost of filling out the form. There
is no associated burden for hospices to communicate/coordinate with
non-hospice providers regarding the content of the addendum statement
because the hospice CoPs, as described above, have always required
hospices to have a system of communication with non-hospice providers
in place. However, we believe that the election statement addendum
would reduce burden for non-hospice providers through a consistent and
streamlined process by which non-hospice providers can make informed
treatment decisions and accurately submit claims with the appropriate
condition code or modifier.
1. Estimated Hospice Burden With Election Statement Addendum
a. Estimated One-Time Form Development
We estimate a one-time burden for the development of a template
election statement addendum. We estimate that it would take a hospice
administrative assistant 15 minutes (15/60 = 0.25 hours) to develop the
addendum with the required elements, and the hospice administrator 15
minutes (15/60 = 0.25 hours) to review the addendum. The clerical time
plus administrator time equals a one-time burden of 30 minutes or (30/
60 = 0.50 hours) per hospice. For all 4,465 hospices, the total time
required would be (0.50 x 4,465) = 2,232.5 hours. At $59.18 per hour
for an executive administrative assistant, the cost per hospice would
be (0.25 x $59.18) = $14.80. At $119.12 per hour for the
administrator's time, the cost per hospice would be (0.25 x $119.12) =
$29.78. Therefore, the one-time cost, per hospice, for the development
of the template would be ($14.80 + 29.78) = $44.58, and the total one-
time cost for all hospices would be ($44.58 x 4,465) = $199,050.
b. Estimated Time for Hospice To Complete Addendum
Per the hospice CoPs at Sec. 418.56(a), the hospice must designate
a registered nurse that is a member of the interdisciplinary group to
provide coordination of care and to ensure continuous assessment of
each patient's and family's needs and implementation of the
interdisciplinary plan of care. The hospice CoPs at Sec. 418.54
require that a registered nurse conduct the initial assessment,
therefore, the registered nurse would be responsible for completing the
addendum for each hospice election as part of the routine admission
paperwork. We estimate that there would be 1,268,497 hospice elections
in a year based on FY 2017 claims data. Approximately 28 percent of
hospice beneficiaries die within the first 5 days after the hospice
election date. Hospices would not be required to complete the election
statement addendum for those hospice beneficiaries that die within 5
days of hospice election. Therefore, the estimated total number of
hospice elections in FY 2020 that would require the hospice election
statement addendum would be (1,268,497 x 0.72) = 913,318. There are
4,465 Medicare-certified hospices, so on average there would be
(913,318/4,465) = 205 hospice elections per hospice. The estimated
burden for the hospice registered nurse to extrapolate this information
from the existing documentation in the patient's hospice medical record
and complete this addendum would be 10 minutes (10/60 = 0.1667). At
$72.60 per hour for a registered nurse over 10 minutes (0.1667 x $72.60
= $12.10), we estimate the total cost of RN time to complete the
addendum per hospice in FY 2020 to be ($12.10 x 205) = $2,481, and the
total cost of RN time to complete the addendum for all hospices in FY
2020 would be ($2,481 x 4,465) = $11,077,665. The estimated total per
hospice and total annual hospice cost associated with the proposed
addendum (including one-time form development and total RN costs) in FY
2020 are shown in Table 20 below. These total costs would include the
one-time development of the addendum, so subsequent years' costs would
only include the cost for the RN to complete the addendum statement.
Providing this information to the beneficiary would be part of the
routine admissions process and, as such, incurs no additional burden to
that process.
[[Page 38535]]
[GRAPHIC] [TIFF OMITTED] TR06AU19.038
2. Estimated Burden Reduction for Non-Hospice Providers
To ensure comprehensive and coordinated care, the CoPs at Sec.
418.56(e) require hospices to have a communication system that allows
for the exchange of information with other non-hospice health care
providers who are furnishing care unrelated to the terminal illness and
related conditions. Therefore, it is our expectation that hospices are
already determining what is related and unrelated to the terminal
illness and related conditions. The election statement addendum would
add no additional burden for communicating with non-hospice providers,
as this decision-making process has been a long-standing CoP
requirement, as described above and in the preamble of this final rule.
However, burden would be reduced for non-hospice providers, including
institutional, non-institutional and pharmacy providers because less
time would be spent trying to obtain needed information for treatment
decisions and accurate claims submissions.
For the calculation of this burden estimate, we did drop those
elections where the beneficiary died within the first 5 days. To
estimate the cost burden reduction, we first calculated the estimated
current burden, in the absence of the addendum, for communicating and
coordinating information regarding unrelated conditions between hospice
and non-hospice providers. Next, we calculated the estimated burden,
using the addendum for communicating and coordinating information
regarding unrelated conditions between hospice and non-hospice
providers. Finally, we analyzed the difference between the burden
estimates to see if there is any overall reduction. To do this, we
analyzed all Medicare Parts A and B non-hospice claims for
beneficiaries under a hospice election in FY 2017. We also examined the
Part D claims for drugs provided to hospice beneficiaries under a
hospice election. Specifically, we analyzed the following:
The total number of non-hospice, institutional claims with
condition code 07 (to indicate the services were unrelated to the
terminal illness and related conditions).
The total number of non-hospice, non-institutional claims
with ``GW'' modifier (to indicate the services were unrelated to the
terminal illness and related conditions).
The total number of Part D claims for beneficiaries under
a hospice election.
The average number of hospice beneficiaries per non-
hospice provider with institutional claims with condition code 07.
The average number of hospice beneficiaries per non-
hospice provider with non-institutional claims with ``GW'' modifier.
The average number of hospice beneficiaries per non-
hospice provider with Part D claims.
To calculate the average number of hospice beneficiaries per non-
hospice provider, we count the number of unique beneficiaries
associated with each non-hospice provider as beneficiaries may receive
services by more than one non-hospice provider. This means that some
beneficiaries are double-counted. However, given this estimate is
calculated based on the number of expected communication encounters
between hospices and non-hospice providers, this is the appropriate
approach. Because we double-counted beneficiaries, we expect that
average to be larger than the ratio of unique beneficiaries to unique
non-hospice providers. Table 21 below summarizes Part A, B and D claims
that overlap with hospice episodes in FY 2017.
[[Page 38536]]
[GRAPHIC] [TIFF OMITTED] TR06AU19.039
3. Burden Estimate Without Election Statement Addendum for Non-Hospice
Providers
In order for non-hospice providers to make treatment decisions
regarding services, items, and drugs for hospice beneficiaries and to
submit the appropriate modifier or condition code on Medicare claims,
they need supporting information from the hospice regarding related and
unrelated conditions. As such, we first estimate the current burden
associated with this communication and coordination in the absence of
the election statement addendum. We believe this would require the non-
hospice providers to contact the hospice and have a detailed phone call
to obtain and document the information on unrelated conditions, items,
services, and medications. For non-hospice providers submitting
institutional claims (including inpatient acute care hospitals, SNFs,
HHAs, and institutional outpatient providers), typically nurse case
managers provide coordination of care for those beneficiaries in these
settings who are receiving inpatient services or who are preparing to
transition to a post-acute care setting or home. The estimated burden
for the registered nurse to contact the hospice to obtain the needed
information would be 15 minutes (15/60 = 0.25). The average number of
hospice beneficiaries receiving services per institutional, non-hospice
provider is 11 per year, which would mean each institutional, non-
hospice provider would have an average of 11 communication encounters
with hospice. The total number of institutional, non-hospice providers
servicing hospice beneficiaries in FY 2017 was 19,226. At $72.60 per
hour for a registered nurse (0.25 x $72.60) = $18.15, we estimate the
total cost per institutional, non-hospice provider furnishing services
to hospice beneficiaries in FY 2020 to be ($18.15 x 11) = $199.65 and
the annual total cost for all institutional, non-hospice providers in
FY 2018 would be ($199.65 x 19,226) = $3,838,471.
For non-institutional, non-hospice providers (including
physicians), we also expect that a nurse would contact the hospice to
obtain the needed clinical information on unrelated conditions, items,
services and drugs. The estimated burden for the registered nurse to
contact the hospice to obtain the needed information would be 15
minutes (15/60 = 0.25). The average number of hospice beneficiaries
receiving services per non-institutional, non-hospice provider is 11
per year, which would mean each provider would have an average of 11
communication encounters with a hospice. The total number of non-
institutional, non-hospice providers servicing hospice beneficiaries in
FY 2017 was 74,933. At $72.60 per hour for a registered nurse (0.25 x
$72.60) = $18.15, we estimate the total cost per non-institutional,
non-hospice provider furnishing services to hospice beneficiaries in FY
2020 to be ($18.15 x 11) = $199.65 and the annual total cost for all
non-institutional, non-hospice providers in FY 2018 would be ($199.65 x
74,933) = $14,960,373.
For pharmacies dispensing Part D drugs to hospice beneficiaries,
the estimated burden for the pharmacy technician at the point of
service to contact the hospice to obtain the needed clinical
information regarding the drugs deemed by the hospice as unrelated to
the terminal illness and related conditions would be 15 minutes (15/60
= 0.25). The average number of hospice beneficiaries receiving services
per pharmacy dispensing Part D maintenance drugs is 12 per year, which
would mean each pharmacy would have an average of 12 communication
encounters with hospice. The total number of pharmacies dispensing Part
D maintenance drugs to hospice beneficiaries in FY 2017 was 60,632. At
$32.70 per hour for a pharmacy technician (0.25 x $32.70) = $8.18, we
estimate the total cost per pharmacy dispensing Part D maintenance
drugs to be ($8.18 x 12) = $98.16 and the annual total cost for all
pharmacies dispensing Part D maintenance drugs to be ($98.16 x 60,632)
= $5,951,637. The estimated total annual burden for all non-hospice
providers furnishing services, items and medications to hospice
beneficiaries in FY 2020 without the availability of the hospice
election statement addendum identifying unrelated conditions, items,
services and drugs would be $24,750,481 ($3,838,471 + $14,960,373 +
$5,951,637).
4. Burden Reduction Estimate With Election Statement Addendum for Non-
Hospice Providers
However, with the availability of the ``Patient Notification of
Hospice Covered/Non-Covered Items, Services, and Drugs'' election
statement addendum, we believe this estimated burden would be reduced
for non-hospice providers through a streamlining of the communication
and coordination process. For institutional, non-hospice providers
(those who would submit claims for unrelated services with condition
code 07), the estimated burden for the registered nurse to contact the
hospice to obtain the needed information would be reduced from 15
minutes in the absence of the addendum to 5 minutes (5/60 = 0.0833).
The average number of hospice beneficiaries receiving services per
institutional non-hospice provider is 11 per year. The total number of
institutional non-hospice providers servicing hospice beneficiaries in
FY 2017 was 19,226. At $72.60 per hour for a registered nurse (0.0833 x
$72.60) = $6.05, we estimate the total cost per institutional non-
hospice provider in FY 2020 to be ($6.05 x 11) = $66.55 and the
[[Page 38537]]
annual total cost for all institutional non-hospice providers in FY
2020 would be ($66.55 x 19,226) = $1,279,490 an annual decrease in
burden by ($3,838,471 - 1,279,490) = $2,558,981.
For non-institutional, non-hospice providers (those who would
submit claims for unrelated services with modifier GW), the estimated
burden for the registered nurse to contact the hospice to obtain the
needed information would be reduced to 5 minutes (5/60 = 0.0833). The
average number of hospice beneficiaries receiving services per non-
institutional, non-hospice provider is 11 per year. The total number of
non-institutional, non-hospice providers servicing hospice
beneficiaries in FY 2017 was 74,933. At $72.60 per hour for a
registered nurse (0.0833 x $72.60) = $6.05, we estimate the total cost
per non-institutional, non-hospice provider in FY 2020 to be ($6.05 x
11) = $66.55 and the annual total cost for all non-institutional, non-
hospice providers in FY 2020 would be ($66.55 x 74,933) = $4,986,791,
an annual decrease in burden by ($14,960,373 - 4,986,791) = $9,973,582.
For pharmacies dispensing Part D drugs to hospice beneficiaries,
the estimated burden for the pharmacy technician at the point of
service to contact the hospice to obtain the needed clinical
information regarding the drugs deemed by the hospice as unrelated to
the terminal illness and related conditions would be reduce to 5
minutes (5/60 = 0.0833). The average number of hospice beneficiaries
receiving services from pharmacies dispensing Part D maintenance drugs
is 12 per year. The total number of pharmacies dispensing Part D
maintenance drugs to hospice beneficiaries in FY 2017 was 60,632. At
$32.70 per hour for a pharmacy technicians (0.0833 x $32.70) = $2.72,
we estimate the total cost per pharmacies dispensing Part D maintenance
drugs to be ($2.72 x 12) = $32.64 and the annual total cost for all
pharmacies dispensing Part D maintenance drugs to be ($32.64 x 60,632)
= $1,979,028, an annual decrease in burden by ($5,951,637 - $1,979,028)
= $3,972,609. The estimated total annual burden for all non-hospice
providers furnishing services, items and drugs to hospice beneficiaries
in FY 2020 with the availability of the hospice election statement
addendum identifying unrelated conditions, items, services and
medication would be $8,245,309 ($1,279,490 + $4,986,791 + $1,979,028)
for an overall burden reduction of ($24,750,481 - $8,245,309) =
$16,505,172. The total reduction in burden for all institutional, non-
institutional, and Part D pharmacy non-hospice providers is summarized
in Table 22 below.
[GRAPHIC] [TIFF OMITTED] TR06AU19.040
The use of the ``Patient Notification of Hospice Non-Covered Items,
Services, and Drugs'' election statement addendum would result in an
estimated, annual net reduction in burden of $5,228,457 ($11,276,715-
$16,505,172) in FY 2020. Table 23 below summarizes the FY 2020
estimated total burden reduction.
[[Page 38538]]
[GRAPHIC] [TIFF OMITTED] TR06AU19.041
B. Comments
We note that many commenters stated that CMS underestimated the
amount of time it would take for the nurse to complete the addendum
stating that 10 minutes is an insufficient amount of time to
extrapolate this information from the existing documentation. A few
commenters stated that this would take between 20 and 30 minutes to
complete. Others stated that this is not just a process of
extrapolating the information, but that this is often a process of
information gathering as not all relevant information is readily
available at the time of the initial assessment. However, a few
commenters believed that even though the timeframe to complete the
addendum would be longer than 10 minutes, they suggested that the
addendum should not be optional but patients (or their representatives)
should be provided this detailed list as this is critical to the care
process, patient empowerment, quality of care, and transparency.
However, we remind hospices that the addendum is only required if the
beneficiary (or representative) requests this information, though for
purposes of this burden reduction estimate we calculate it as it every
eligible beneficiary requests the addendum. Additionally, there are
those hospices that will cover all items, services, and drugs, and
therefore, this would further reduce the number of hospice elections in
which the addendum would be provided. Furthermore, if a beneficiary
requests the addendum at the time of hospice election but dies within 5
days, the hospice would not be required to furnish the addendum and the
requirement would be deemed as having being met in this circumstance.
C. Submission of PRA-Related Comments
We have submitted a copy of this final 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.
To obtain copies of the supporting statement and any related forms
for the proposed collections previously discussed, visit our website
at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html, or call the Reports
Clearance Office at (410) 786-1326.
VI. Regulatory Impact Analysis
A. Statement of Need
This final rule meets the requirements of our regulations at Sec.
418.306(c) and (d), which require annual issuance, in the Federal
Register, of the hospice wage index based on the most current available
CMS hospital wage data, including any changes to the definitions of
Core-Based Statistical Areas (CBSAs) or previously used Metropolitan
Statistical Areas (MSAs), as well as any changes to the methodology for
determining the per diem payment rates. This final rule also updates
payment rates for each of the categories of hospice care, described in
Sec. 418.302(b), for FY 2020 as required under section
1814(i)(1)(C)(ii)(VII) of the Act. The payment rate updates are subject
to changes in economy-wide productivity as specified in section
1886(b)(3)(B)(xi)(II) of the Act. Lastly, section 3004 of the
Affordable Care Act amended the Act to authorize a quality reporting
program for hospices, and this rule discusses changes in the
requirements for the hospice quality reporting program in accordance
with section 1814(i)(5) of the Act.
B. Overall Impacts
We estimate that the aggregate impact of the payment provisions in
this final rule would result in an estimated increase of $520 million
in payments to hospices, resulting from the hospice payment update
percentage of 2.6 percent for FY 2020. Section 1814(i)(6)(D)(ii) of the
Act requires the final rebasing of the per diem payment rates for CHC,
GIP, and IRC to be done in a budget-neutral manner in the first year of
implementation. Therefore, the final rebased rates for CHC, GIP, and
IRC would not result in an overall payment impact for the Medicare
program as we are finalizing the reduction of the RHC payment rates to
ensure that total estimated payments to hospices are budget-neutral
given the increases to the CHC, GIP, and IRC payment rates. In
addition, the final change in the hospice wage index to use the FY 2020
pre-floor, pre-reclassified hospital wage index (rather than the FY
2019 pre-floor, pre-reclassified hospital wage index) as the basis for
the FY 2020 hospice wage index would not result in an overall payment
impact for the Medicare program as annual wage index updates are now
similarly implemented in a budget-neutral manner. 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
[[Page 38539]]
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), the Congressional Review Act (5 U.S.C.
804(2)), and Executive Order 13771 on Reducing Regulation and
Controlling Regulatory Costs (January 30, 2017).
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 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 Regulatory Flexibility Act (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 $7.5 million to $38.5 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. HHS's 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 2020 hospice payment update
percentage results in an overall increase in estimated hospice payments
of 2.6 percent, or $520 million. The distributional effects of the
final FY 2020 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. Finally, the distributional effects of the final
FY 2020 increases to the CHC, IRC, and GIP per diem payment rates as a
result of rebasing, offset by a decrease to the FY 2020 RHC payment
rates of less than 3 percent to maintain budget neutrality in the first
year of implementation, 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 Social Security Act requires us
to prepare a regulatory impact analysis if a rule may have a
significant impact on the operations of a substantial number of small
rural hospitals. This analysis must conform to the provisions of
section 604 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a metropolitan statistical area 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.
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 2019 UMRA
threshold is $154 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 $154 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 final 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 the published proposed rule will be the number of
reviewers of this final rule. We acknowledge that this assumption may
understate or overstate the costs of reviewing this final rule. It is
possible that not all commenters reviewed the proposed rule in detail,
and it is also possible that some reviewers chose not to comment on the
proposed rule. For these reasons we thought that the number of past
commenters would be a fair estimate of the number of reviewers of this
final rule.
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 $107.38 per hour,
including overhead and fringe benefits (https://www.bls.gov/oes/current/oes_nat.htm). This final rule consists of approximately 57,000
words in its entirety. Assuming an average reading speed of 250 words
per minute, it would take approximately 2 hours for the staff to review
half of it. For each hospice that reviews the rule, the estimated cost
is approximately $215.00 (2 hours x $107.38). Therefore, we estimate
that the total cost of reviewing this regulation is $32,250 ($215.00 x
150 reviewers).
D. Detailed Economic Analysis
1. Hospice Payment Update for FY 2020
The FY 2020 hospice payment impacts appear in Table 24. 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
[[Page 38540]]
second column shows the number of hospices in each of the categories in
the first column. The third column shows the effects of applying the
final rebased payment rates of CHC, IRC, and GIP (and the decreased RHC
rate used to achieve budget neutrality). The fourth column shows the
hospice payments using FY 2018 Hospice Claims, FY 2020 rebased
Payments, and FY 2020 Wage Index without the 1-Year lag. The fifth
column show the final FY 2020 hospice payment update percentage of 2.6
percent as mandated by section 1814(i)(1)(C) of the Act, and is
consistent for all providers. The 2.6 percent hospice payment update
percentage is based on an estimated 3.0 percent inpatient hospital
market basket update, reduced by a 0.4 percentage point productivity
adjustment. It is projected that aggregate payments would increase by
2.6 percent, assuming hospices do not change their service and billing
practices. The sixth column shows the total impact for FY 2020. We have
set the rates so the overall impact is zero percent due to the
requirement that any revisions in payment are implemented in a budget-
neutral manner in accordance with section 1814(i)(6)(D)(ii) of the Act
(accomplished by rebasing the CHC, GIP, and IRC payment rates by a
corresponding decrease to the RHC payment rates).
In addition, to assist providers in understanding the impacts of
the final wage index without the lag and the rebasing of CHC, IRC, and
GIP, 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 2018 as
seen on Medicare hospice claims (accessed from the CCW in May 2019) 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 24, the combined effects of all the
proposals vary by specific types of providers and by location.
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2. Hospice Election Statement Addendum
This final rule includes requirements related to the election
statement addendum that must be provided, upon request, to hospice
beneficiaries (or representative), non-hospice providers, and Medicare
contractors. This change is effective for hospice elections on and
after October 1, 2020. The burden estimate for hospices to develop and
complete the election statement addendum is provided in section V of
this final rule. However, the election statement addendum adds no
additional burden for communicating with non-hospice providers, as this
decision-making process has been a long-standing CoP requirement, as
described in the preamble of this rule. Furthermore, burden would be
reduced for non-hospice providers, including institutional, non-
institutional and pharmacy providers because less time would be spent
trying to obtain needed information for treatment decisions and
accurate claims submissions. As a result of this election statement
addendum, we estimate that this rule generates $5.2 million in an
annualized net reduction in burden, or $3.7 million per year on an
ongoing basis discounted at 7 percent relative to year 2016, over a
perpetual time horizon beginning in FY 2021. The burden reduction
estimate for the addendum is detailed in section V of this final rule
and the total annual reduction is included in Table 25.
E. 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 25, we have prepared an accounting statement showing the
classification of the transfers and costs associated with the
provisions of this final rule. This table shows an estimated $520
million in transfers to hospices in FY 2020. All expenditures are
classified as transfers to hospices. Table 25 also reflects the
estimated change in costs and burden for hospices and non-hospice
providers as a result of the finalized election statement addendum
requirements described in section III.C. Table 20 provides our best
estimate of a one-time burden for hospices to develop the election
statement addendum form of approximately 2,233 hours or $199,050, as
well as our estimate of the annual burden for hospices to complete the
election statement addendum of approximately 746 hours or $11 million
for an estimated total burden for hospices of $11.2 million, as
described in section IV of this final rule. Additionally, we estimate a
net reduction in burden for non-hospice providers of approximately
25,900 hours or $16.5 million (see section IV of this final rule) for
an
[[Page 38543]]
estimated overall, annualized net reduction in burden with the proposed
election statement addendum of $5.2 million.
[GRAPHIC] [TIFF OMITTED] TR06AU19.044
F. Regulatory Reform Analysis Under E.O. 13771
Executive Order 13771, entitled ``Reducing Regulation and
Controlling Regulatory Costs,'' was issued on January 30, 2017 (82 FR
9339, February 3, 2017) and requires that the costs associated with
significant new regulations ``shall, to the extent permitted by law, be
offset by the elimination of existing costs associated with at least
two prior regulations.'' This final rule is expected to be an E.O.
13771 deregulatory action with $5.2 million in an annualized net
reduction in burden, or $3.7 million per year on an ongoing basis
discounted at 7 percent relative to year 2016, over a perpetual time
horizon beginning in FY 2021. The burden reduction for the addendum is
detailed in section V of this final rule and the total annual net
reduction in burden is included in Table 25. Details on the estimated
net reduction in burden of this rule can be found in the rule's
collection of information and economic analysis.
G. Conclusion
We estimate that aggregate payments to hospices in FY 2020 will
increase by $520 million, or 2.6 percent, compared to payments in FY
2019. We estimate that in FY 2020, hospices in urban and rural areas
will experience, on average, 2.7 percent and 1.8 percent increases,
respectively, in estimated payments compared to FY 2019. Hospices
providing services in the South Atlantic, Middle Atlantic, and East
North Central regions would experience the largest estimated increases
in payments of 4.5 percent, 2.6 percent, and 2.6 percent, respectively.
Hospices serving patients in the West North Central and outlying
regions would experience, on average, the lowest estimated increase of
1.4 percent and -0.3 percent, respectively in FY 2020 payments. We are
finalizing the modifications to the election statement including the
election statement addendum in this final rule with an implementation
date of October 1, 2020 to allow hospices additional time to make the
necessary changes to meet these requirements. We also estimate an
overall net reduction in burden of $5.2 million beginning in FY 2021 as
a result of the finalized election statement addendum. 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 amends 42 CFR chapter IV as set forth below.
PART 418--HOSPICE CARE
0
1. The authority citation for part 418 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
2. Section 418.3 is amended by adding the definition of ``BFCC-QIO'' to
read as follows:
Sec. 418.3 Definitions.
* * * * *
[[Page 38544]]
BFCC-QIO means Beneficiary and Family Centered Care Quality
Improvement Organization.
* * * * *
0
3. Section 418.24 is amended by --
0
a. Revising paragraphs (b)(2) and (3);
0
b. Redesignating paragraph (b)(5) as paragraph (b)(8);
0
c. Adding new paragraphs (b)(5), (6), and (7);
0
d. Redesignating paragraphs (c) through (f) as paragraphs (d) through
(g) respectively; and
0
e. Adding a new paragraph (c).
The revisions and additions read as follows:
Sec. 418.24 Election of hospice care.
* * * * *
(b) * * *
(2) The individual's or representative's acknowledgement that he or
she has been given a full understanding of the palliative rather than
curative nature of hospice care, as it relates to the individual's
terminal illness and related conditions.
(3) Acknowledgement that the individual has been provided
information on the hospice's coverage responsibility and that certain
Medicare services, as set forth in paragraph (e) of this section, are
waived by the election. For Hospice elections beginning on or after
October 1, 2020, this would include providing the individual with
information indicating that services unrelated to the terminal illness
and related conditions are exceptional and unusual and hospice should
be providing virtually all care needed by the individual who has
elected hospice.
* * * * *
(5) For Hospice elections beginning on or after October 1, 2020,
the Hospice must provide information on individual cost-sharing for
hospice services.
(6) For Hospice elections beginning on or after October 1, 2020,
the Hospice must provide notification of the individual's (or
representative's) right to receive an election statement addendum, as
set forth in paragraph (c) of this section, if there are conditions,
items, services, and drugs the hospice has determined to be unrelated
to the individual's terminal illness and related conditions and would
not be covered by the hospice.
(7) For Hospice elections beginning on or after October 1, 2020,
the Hospice must provide information on the Beneficiary and Family
Centered Care Quality Improvement Organization (BFCC-QIO), including
the right to immediate advocacy and BFCC-QIO contact information.
* * * * *
(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. If the
election statement addendum is requested at the time of 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. If this
addendum is requested during the course of hospice care (that is, after
the hospice election date), the hospice must provide this information,
in writing, within 72 hours of the request to the requesting individual
(or representative), non-hospice provider, or Medicare contractor. If
there are any changes to the content on the addendum during the course
of hospice care, the hospice must update the addendum and provide these
updates, in writing, to the individual (or representative). The
election statement addendum must include the following:
(1) The addendum must be titled ``Patient Notification of Hospice
Non-Covered Items, Services, and Drugs.''
(2) Name of the hospice.
(3) Individual's name and hospice medical record identifier.
(4) Identification of the individual's terminal illness and related
conditions.
(5) A list of the individual's conditions present on hospice
admission (or upon plan of care update) 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 individual (or
representative) can understand, as to why the identified conditions,
items, services, and drugs are considered unrelated to the individual's
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 whether or not conditions,
items, services, and drugs are related is made for each patient and
that the individual should share this clinical explanation with other
health care providers from which they seek items, services, or drugs
unrelated to their terminal illness and related conditions.
(7) References to any relevant clinical practice, policy, or
coverage guidelines.
(8) Information on the following:
(i) Purpose of Addendum. The purpose of the addendum is to notify
the individual (or representative), in writing, of those conditions,
items, services, and drugs the hospice will not be covering because the
hospice has determined they are unrelated to the individual's terminal
illness and related conditions.
(ii) Right to Immediate Advocacy. The addendum must include
language that immediate advocacy is available through the Medicare
Beneficiary and Family Centered Care-Quality Improvement Organization
(BFCC-QIO) if the individual (or representative) disagrees with the
hospice's determination.
(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 necessarily the individual's (or representative's)
agreement with the hospice's determinations.
* * * * *
Sec. 418.26 [Amended]
0
4. Section 418.26 is amended in paragraph (c)(2) by removing the
reference ``Sec. 418.24(d)'' and adding in its place the reference
``Sec. 418.24(e)''.
Sec. 418.28 [Amended]
0
5. Section 418.28 is amended in paragraph (c)(2) by removing the
reference ``Sec. 418.24(e)(2)'' and adding in its place the reference
``Sec. 418.24(f)(2)''.
Dated: July 25, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: July 26, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-16583 Filed 7-31-19; 4:15 pm]
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