[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Rules and Regulations]
[Pages 52143-52194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18221]
[[Page 52143]]
Vol. 81
Friday,
No. 151
August 5, 2016
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 2017 Hospice Wage Index and Payment Rate Update
and Hospice Quality Reporting Requirements; Final Rule
Federal Register / Vol. 81 , No. 151 / Friday, August 5, 2016 / Rules
and Regulations
[[Page 52144]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 418
[CMS-1652-F]
RIN 0938-AS79
Medicare Program; FY 2017 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 will update the hospice wage index, payment
rates, and cap amount for fiscal year (FY) 2017. In addition, this rule
changes the hospice quality reporting program, including adopting new
quality measures. Finally, this final rule includes information
regarding the Medicare Care Choices Model (MCCM).
DATES: These regulations are effective on October 1, 2016.
FOR FURTHER INFORMATION CONTACT: Debra Dean-Whittaker, (410) 786-0848
for questions regarding the CAHPS[supreg] Hospice Survey.
Michelle Brazil, (410) 786-1648 for questions regarding the hospice
quality reporting program.
Hillary A. Loeffler, (410) 786-0456 for questions regarding hospice
payment policy.
SUPPLEMENTARY INFORMATION: Wage index addenda will be available only
through the internet on the CMS Web site at: (http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/index.html.)
Table of Contents
I. Executive Summary
A. Purpose
B. Summary of the Major Provisions
C. Summary of Impacts
II. Background
A. Hospice Care
B. History of the Medicare Hospice Benefit
C. Services Covered by the Medicare Hospice Benefit
D. Medicare Payment for Hospice Care
1. Omnibus Budget Reconciliation Act of 1989
2. Balanced Budget Act of 1997
3. FY 1998 Hospice Wage Index Final Rule
4. FY 2010 Hospice Wage Index Final Rule
5. The Affordable Care Act
6. FY 2012 Hospice Wage Index Final Rule
7. FY 2015 Hospice Wage Index and Payment Rate Update Final Rule
8. Impact Act of 2014
9. FY 2016 Hospice Wage Index and Payment Rate Update Final Rule
E. Trends in Medicare Hospice Utilization
F. Use of Health Information Technology
III. Provisions of the Final Rule
A. Monitoring for Potential Impacts--Affordable Care Act Hospice
Reform
B. FY 2017 Hospice Wage Index and Rates Update
1. FY 2017 Hospice Wage Index
a. Background
b. FY 2016 Implementation of New Labor Market Delineations
2. FY 2017 Hospice Payment Update Percentage
3. FY 2017 Hospice Payment Rates
4. Hospice Cap Amount for FY 2017
C. Updates to the Hospice Quality Reporting Program
1. Background and Statutory Authority
2. General Considerations Used for Selection of Quality Measures
for the HQRP
3. Policy for Retention of HQRP Measures Adopted for Previous
Payment Determination
4. Previously Adopted Quality Measures for FY 2017 and FY 2018
Payment Determination
5. Proposed Removal of Previously Adopted Measures
6. Proposed New Quality Measures for FY 2019 Payment
Determinations and Subsequent Years and Concepts Under Consideration
for Future Years
a. Background and Considerations in Developing New Quality
Measures for the HQRP
b. New Quality Measures for the FY 2019 Payment Determination
and Subsequent Years
7. Form, Manner, and Timing of Quality Data Submission
a. Background
b. Previously Finalized Policy for New Facilities To Begin
Submitting Quality Data
c. Previously Finalized Data Submission Mechanism, Collection
Timelines, and Submission Deadlines for the FY 2017 Payment
Determination
d. Previously Finalized Data Submission Timelines and
Requirements for FY 2018 Payment Determination and Subsequent Years
e. Previously Finalized HQRP Data Submission and Compliance
Thresholds for the FY 2018 Payment Determination and Subsequent
Years
f. New Data Collection and Submission Mechanisms Under
Consideration for Future Years
8. HQRP Submission Exemption and Extension Requirements for the
FY 2017 Payment Determination and Subsequent Years
9. Hospice CAHPS[supreg] Participation Requirements for the 2019
APU and 2020 APU
a. Background Description of the Survey
b. Participation Requirements To Meet Quality Reporting
Requirements for the FY 2019 APU
c. Participation Requirements To Meet Quality Reporting
Requirements for the FY 2020 APU
d. Annual Payment Update
e. Hospice CAHPS[supreg] Reconsiderations and Appeals Process
10. HQRP Reconsideration and Appeals Procedures for the FY 2017
Payment Determination and Subsequent Years
11. Public Display of Quality Measures and Other Hospice Data
for the HQRP
D. The Medicare Care Choices Model
IV. Collection of Information Requirements
V. Economic Analyses
VI. Federalism Analysis and Regulations Text
Acronyms
Because of the many terms to which we refer by acronym in this
final rule, we are listing the acronyms used and their corresponding
meanings in alphabetical order:
APU Annual Payment Update
ASPE Assistant Secretary of Planning and Evaluation
BBA Balanced Budget Act of 1997
BIPA Benefits Improvement and Protection Act of 2000
BNAF Budget Neutrality Adjustment Factor
BLS Bureau of Labor Statistics
CAHPS[supreg] Consumer Assessment of Healthcare Providers and
Systems
CBSA Core-Based Statistical Area
CCN CMS Certification Number
CCW Chronic Conditions Data Warehouse
CFR Code of Federal Regulations
CHC Continuous Home Care
CHF Congestive Heart Failure
CMMI Center for Medicare & Medicaid Innovation
CMS Centers for Medicare & Medicaid Services
COPD Chronic Obstructive Pulmonary Disease
CoPs Conditions of Participation
CPI Center for Program Integrity
CPI-U Consumer Price Index--Urban Consumers
CR Change Request
CVA Cerebral Vascular Accident
CWF Common Working File
CY Calendar Year
DME Durable Medical Equipment
DRG Diagnostic Related Group
ER Emergency Room
FEHC Family Evaluation of Hospice Care
FR Federal Register
FY Fiscal Year
GAO Government Accountability Office
GIP General Inpatient Care
HCFA Healthcare Financing Administration
HHS Health and Human Services
HIPAA Health Insurance Portability and Accountability Act
HIS Hospice Item Set
HQRP Hospice Quality Reporting Program
IACS Individuals Authorized Access to CMS Computer Services
ICD-9-CM International Classification of Diseases, Ninth Revision,
Clinical Modification
ICD-10-CM International Classification of Diseases, Tenth Revision,
Clinical Modification
ICR Information Collection Requirement
IDG Interdisciplinary Group
IMPACT Act Improving Medicare Post-Acute Care Transformation Act of
2014
IOM Institute of Medicine
IPPS Inpatient Prospective Payment System
IRC Inpatient Respite Care
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LCD Local Coverage Determination
LOS Length of Stay
MAC Medicare Administrative Contractor
MAP Measure Applications Partnership
MCCM Medicare Care Choices Model
MedPAC Medicare Payment Advisory Commission
MFP Multifactor Productivity
MSA Metropolitan Statistical Area
MSS Medical Social Services
NHPCO National Hospice and Palliative Care Organization
NF Long Term Care Nursing Facility
NOE Notice of Election
NOTR Notice of Termination/Revocation
NP Nurse Practitioner
NPI National Provider Identifier
NQF National Quality Forum
OIG Office of the Inspector General
OACT Office of the Actuary
OMB Office of Management and Budget
PEPPER Program for Evaluating Payment Patterns Electronic Report
PRRB Provider Reimbursement Review Board
PS&R Provider Statistical and Reimbursement Report
Pub. L. Public Law
QAPI Quality Assessment and Performance Improvement
RHC Routine Home Care
RN Registered Nurse
SBA Small Business Administration
SEC Securities and Exchange Commission
SIA Service Intensity Add-on
SNF Skilled Nursing Facility
TEFRA Tax Equity and Fiscal Responsibility Act of 1982
TEP Technical Expert Panel
UHDDS Uniform Hospital Discharge Data Set
U.S.C. United States Code
I. Executive Summary
A. Purpose
This final rule updates the hospice payment rates for fiscal year
(FY) 2017, as required under section 1814(i) of the Social Security Act
(the Act). This rule also finalizes new quality measures and provides
an update on the hospice quality reporting program (HQRP) consistent
with the requirements of section 1814(i)(5) of the Act, as added by
section 3004(c) of the Patient Protection and Affordable Care Act (Pub.
L. 111-148) as amended by the Health Care and Education Reconciliation
Act (Pub. L. 111-152) (collectively, the Affordable Care Act). In
accordance with section 1814(i)(5)(A) of the Act, starting in FY 2014,
hospices that have failed to meet quality reporting requirements
receive a 2 percentage point reduction to their payments. Finally, this
final rule shares information on the Medicare Care Choices Model
developed in accordance with the authorization under section 1115A of
the Act for the Center for Medicare and Medicaid Innovation (CMMI) to
test innovative payment and service models that have the potential to
reduce Medicare, Medicaid, or Children's Health Insurance Program
(CHIP) expenditures while maintaining or improving the quality of care.
B. Summary of the Major Provisions
In section III.B.1 of this rule, we update the hospice wage index
with updated wage data and make the application of the updated wage
data budget-neutral for all four levels of hospice care. In section
III.B.2 we discuss the FY 2017 hospice payment update percentage of 2.1
percent. Sections III.B.3 and III.B.4 update the hospice payment rates
and hospice cap amount for FY 2017 by the hospice payment update
percentage discussed in section III.B.2.
In section III.C of this rule, we discuss updates to HQRP,
including two new quality measures as well as of the possibility of
utilizing a new assessment instrument to collect quality data. As part
of the HQRP, the new measures, effective April 1, 2017, will be: (1)
Hospice Visits When Death is Imminent, assessing hospice staff visits
to patients and caregivers in the last week of life; and (2) Hospice
and Palliative Care Composite Process Measure, assessing the percentage
of hospice patients who received care processes consistent with
existing guidelines. In section III.C we will also discuss the
enhancement of the current Hospice Item Set (HIS) data collection
instrument to be more in line with other post-acute care settings. This
new data collection instrument will be a comprehensive patient
assessment instrument, rather than the current chart abstraction tool.
Additionally, in this section we discuss our plans for sharing HQRP
data publicly during calendar year (CY) 2016 as well as plans to
provide public reporting via a Compare Site in CY 2017.
Finally, in section III.D, we are providing information regarding
the Medicare Care Choices Model (MCCM). This model is testing a new
option for Medicare and dual eligible beneficiaries with certain
advanced diseases who meet the model's other eligibility criteria to
receive hospice-like support services from MCCM participating hospices
while receiving care from other Medicare providers for their terminal
illness. This model is designed to: (1) Increase access to supportive
care services provided by hospice; (2) improve quality of life and
patient/family/caregiver satisfaction; and (3) inform new payment
systems for the Medicare and Medicaid programs.
C. Summary of Impacts
Table 1--Impact Summary Table
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Provision description Transfers
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FY 2017 Hospice Wage Index and Payment The overall economic impact of
Rate Update. this final rule is estimated
to be $350 million in
increased payments to hospices
during FY 2017.
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II. Background
A. Hospice Care
Hospice care is an approach to treatment that recognizes that the
impending death of an individual warrants a change in the focus from
curative care to palliative care for relief of pain and for symptom
management. 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 use of a broad
spectrum 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-centered care for those
who are terminally ill. It is a comprehensive, holistic approach to
treatment that recognizes that the impending death of an individual
necessitates a transition from curative to palliative care.
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
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care practices, and is a critical component of the Medicare hospice
benefit. Also, see Hospice Conditions of Participation final rule (73
FR 32088 June 5, 2008). The goal of palliative care in hospice is to
improve the quality of life of beneficiaries, and their families,
facing the issues associated with a life-threatening illness through
the prevention and relief of suffering by means of early
identification, assessment, and treatment of pain and other issues that
may arise. This is achieved by the hospice interdisciplinary group
working with the beneficiary and family to develop a comprehensive care
plan focused on coordinating care services, reducing unnecessary
diagnostics, or ineffective therapies, and offering ongoing
conversations with individuals and their families about changes in
their condition. The beneficiary's comprehensive 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.
Medicare hospice care is palliative care for individuals with a
prognosis of living 6 months or less if the terminal illness runs its
normal course. When a beneficiary is terminally ill, many health
problems are brought on by underlying condition(s), as bodily systems
are interdependent. In the 2008 Hospice Conditions of Participation
final rule, we stated that the medical director or physician designee
must consider the primary terminal condition, related diagnoses,
current subjective and objective medical findings, current medication
and treatment orders, and information about unrelated conditions when
considering the initial certification of the terminal illness. (73 FR
32176). 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 certification of
terminal illness 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 and recertification forms, as set out at
Sec. 418.22(b)(3).
While the goal of hospice care is to allow the beneficiary to
remain in his or her home environment, circumstances during the end-of-
life may necessitate short-term inpatient admission to a hospital,
skilled nursing facility (SNF), or hospice facility for treatment
necessary for pain control or acute or chronic symptom management that
cannot be managed in any other setting. These acute hospice care
services are to ensure that any new or worsening symptoms are
intensively addressed so that the beneficiary can return to his or her
home environment. Limited, short-term, intermittent, inpatient respite
services are also available to the family/caregiver of the hospice
patient to relieve the family or other caregivers. Additionally, an
individual can receive continuous home care during a period of crisis
in which an individual requires primarily continuous nursing care to
achieve palliation or management of acute medical symptoms so that the
individual can remain at home. Continuous home care may be covered on a
continuous basis 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 are expected to comply with all civil rights laws,
including the provision of auxiliary aids and services to ensure
effective communication with patients and patient care representatives
with disabilities consistent with section 504 of the Rehabilitation Act
of 1973 and the Americans with Disabilities Act, and to provide
language access for such persons who are limited in English
proficiency, consistent with Title VI of the Civil Rights Act of 1964.
Further information about these requirements may be found at http://www.hhs.gov/civil-rights.
B. History of the Medicare Hospice Benefit
Before the creation of the Medicare hospice benefit, hospice
programs were originally operated by volunteers who cared for the
dying. During the early development stages of the Medicare hospice
benefit, hospice advocates were clear that they wanted a Medicare
benefit that provided all-inclusive care for terminally-ill
individuals, provided pain relief and symptom management, and offered
the opportunity to die with dignity in the comfort of one's home rather
than in an institutional setting.\1\ As stated in the August 22, 1983
proposed rule titled ``Medicare Program; Hospice Care'' (48 FR 38146),
``the hospice experience in the United States has placed emphasis on
home care. It offers physician services, specialized nursing services,
and other forms of care in the home to enable the terminally ill
individual to remain at home in the company of family and friends as
long as possible.'' The concept of a beneficiary ``electing'' the
hospice benefit and being certified as terminally ill were two key
components of the legislation responsible for the creation of the
Medicare Hospice Benefit (section 122 of the Tax Equity and Fiscal
Responsibility Act of 1982 (TEFRA), (Pub. L. 97-248)). Section 122 of
TEFRA created the Medicare Hospice benefit, which was implemented on
November 1, 1983. Under sections 1812(d) and 1861(dd) of the Act, we
provide coverage of hospice care for terminally ill Medicare
beneficiaries who elect to receive care from a Medicare-certified
hospice. Our regulations at Sec. 418.54(c) stipulate that the
comprehensive hospice assessment must identify the beneficiary's
physical, psychosocial, emotional, and spiritual needs related to the
terminal illness and related conditions, and address those needs in
order to promote the beneficiary's well-being, comfort, and dignity
throughout the dying process. The comprehensive assessment must take
into consideration the following factors: The nature and condition
causing admission (including the presence or lack of objective data and
subjective complaints); complications and risk factors that affect care
planning; functional status; imminence of death; and severity of
symptoms (Sec. 418.54(c)). The Medicare hospice benefit requires the
hospice to cover all reasonable and necessary palliative care related
to the terminal prognosis, as described in the beneficiary's plan of
care. The December 16, 1983 Hospice final rule (48 FR 56008) requires
hospices to cover care for interventions to manage pain and symptoms.
Additionally, the hospice Conditions of Participation (CoPs) at Sec.
418.56(c) require that the hospice must provide all reasonable and
necessary services for the palliation and management of the terminal
illness, related conditions, and interventions to manage pain and
symptoms. Therapy and interventions must be assessed and managed in
terms of providing palliation and comfort without undue symptom burden
for the hospice patient or family.\2\ In the December 16, 1983 Hospice
final rule (48 FR 56010), regarding what is related versus
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unrelated to the terminal illness, we stated: ``. . . we believe that
the unique physical condition of each terminally ill individual makes
it necessary for these decisions to be made on a case by case basis. It
is our general view that hospices are required to provide virtually all
the care that is needed by terminally ill patients.'' Therefore, unless
there is clear evidence that a condition is unrelated to the terminal
prognosis, all conditions are considered to be related to the terminal
prognosis and the responsibility of the hospice to address and treat.
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\1\ Connor, Stephen. (2007). Development of Hospice and
Palliative Care in the United States. OMEGA. 56(1), p. 89-99.
\2\ Paolini, DO, Charlotte. (2001). Symptoms Management at End
of Life. JAOA. 101(10). p. 609-615.
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As stated in the December 16, 1983 Hospice final rule, the
fundamental premise upon which the hospice benefit was designed was the
``revocation'' of traditional curative care and the ``election'' of
hospice care for end-of-life symptom management and maximization of
quality of life (48 FR 56008). After electing hospice care, the
beneficiary typically returns to the home from an institutionalized
setting or remains in the home, to be surrounded by family and friends,
and to prepare emotionally and spiritually, if requested, for death
while receiving expert symptom management and other supportive
services. Election of hospice care also requires waiving the right to
Medicare payment for curative treatment for the terminal prognosis, and
instead receiving palliative care to manage pain or other symptoms.
The benefit was originally designed to cover hospice care for a
finite period of time that roughly corresponded to a life expectancy of
6 months or less. Initially, beneficiaries could receive three election
periods: Two 90-day periods and one 30-day period. Currently, Medicare
beneficiaries can elect hospice care for two 90-day periods and an
unlimited number of subsequent 60-day periods; however, at the
beginning of each period, a physician must certify that the beneficiary
has a life expectancy of 6 months or less if the terminal illness runs
its normal course.
C. Services Covered by the Medicare Hospice Benefit
One requirement for coverage under the Medicare Hospice benefit is
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, Congress 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 and 48 FR
38149). As stated in the August 22, 1983 Hospice proposed rule, the
hospice interdisciplinary group should comprise paid hospice employees
as well as hospice volunteers (48 FR 38149). This expectation supports
the hospice philosophy of holistic, comprehensive, compassionate, end-
of-life care.
Before the Medicare hospice benefit was established, Congress
requested a demonstration project to test the feasibility of covering
hospice care under Medicare. The National Hospice Study was initiated
in 1980 through a grant sponsored by the Robert Wood Johnson and John
A. Hartford Foundations and the Centers for Medicare & Medicaid
Services (CMS) (then, the Health Care Financing Administration (HCFA)).
The demonstration project was conducted between October 1980 and March
1983. The project summarized the hospice care philosophy and principles
as the following:
Patient and family know of the terminal condition.
Further medical treatment and intervention are indicated
only on a supportive basis.
Pain control should be available to patients as needed to
prevent rather than to just ameliorate pain.
Interdisciplinary teamwork is essential in caring for
patient and family.
Family members and friends should be active in providing
support during the death and bereavement process.
Trained volunteers should provide additional support as
needed.
The cost data and the findings on what services hospices provided
in the demonstration project were used to design the Medicare hospice
benefit. The identified hospice services were incorporated into the
service requirements under the Medicare hospice benefit. Importantly,
in the August 22, 1983 Hospice proposed rule, we stated ``the hospice
benefit and the resulting Medicare reimbursement is not intended to
diminish the voluntary spirit of hospices'' (48 FR 38149).
D. 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 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),
Continuous Home Care (CHC), inpatient respite care, and general
inpatient care), 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 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
for the following two changes in the methodology concerning updating
the daily payment rates: (1) Effective January 1, 1990, the daily
payment rates for RHC and other services included in
[[Page 52148]]
hospice care were increased to equal 120 percent of the rates in effect
on September 30, 1989; and (2) the daily payment rate for RHC and other
services included in hospice care for fiscal years (FYs) beginning on
or after October 1, 1990, were the payment rates in effect during the
previous Federal FY increased by the hospital market basket percentage
increase.
2. Balanced Budget Act of 1997
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
updated by a factor equal to the hospital market basket percentage
increase, minus 1 percentage point. Payment rates for FYs from 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 will be the hospital market basket percentage increase for the FY.
The Act requires us to use the inpatient hospital market basket to
determine hospice payment rates.
3. FY 1998 Hospice Wage Index Final Rule
In the August 8, 1997 FY 1998 Hospice Wage Index final rule (62 FR
42860), we implemented a new methodology for calculating the hospice
wage index based on the recommendations of a negotiated rulemaking
committee. The original hospice wage index was based on 1981 Bureau of
Labor Statistics hospital data and had not been updated since 1983. In
1994, because of disparity in wages from one geographical location to
another, the Hospice Wage Index Negotiated Rulemaking Committee was
formed to negotiate a new wage index methodology that could be accepted
by the industry and the government. This Committee was composed of
representatives from national hospice associations; rural, urban, large
and small hospices, and multi-site hospices; consumer groups; and a
government representative. The Committee decided that in updating the
hospice wage index, aggregate Medicare payments to hospices would
remain budget neutral to payments calculated using the 1983 wage index,
to cushion the impact of using a new wage index methodology. To
implement this policy, a Budget Neutrality Adjustment Factor (BNAF) was
computed and applied annually to the pre-floor, pre-reclassified
hospital wage index when deriving the hospice wage index, subject to a
wage index floor.
4. FY 2010 Hospice Wage Index Final Rule
Inpatient hospital pre-floor and pre-reclassified wage index
values, as described in the August 8, 1997 Hospice Wage Index final
rule, are subject to either a budget neutrality adjustment or
application of the wage index floor. Wage index values of 0.8 or
greater are adjusted by the BNAF. Starting in FY 2010, a 7-year phase-
out of the BNAF began (FY 2010 Hospice Wage Index final rule, (74 FR
39384, August 6, 2009)), with a 10 percent reduction in FY 2010, an
additional 15 percent reduction for a total of 25 percent in FY 2011,
an additional 15 percent reduction for a total 40 percent reduction in
FY 2012, an additional 15 percent reduction for a total of 55 percent
in FY 2013, and an additional 15 percent reduction for a total 70
percent reduction in FY 2014. The phase-out continued with an
additional 15 percent reduction for a total reduction of 85 percent in
FY 2015, an additional, and final, 15 percent reduction for complete
elimination in FY 2016. We note that the BNAF was an adjustment which
increased the hospice wage index value. Therefore, the BNAF phase-out
reduced the amount of the BNAF increase applied to the hospice wage
index value. It 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
FY 2013 through FY 2019, the market basket percentage update under the
hospice payment system will be reduced by an additional 0.3 percentage
point (although for FY 2014 to FY 2019, the potential 0.3 percentage
point reduction is subject to suspension under conditions specified in
section 1814(i)(1)(C)(v) of the Act).
In addition, sections 1814(i)(5)(A) through (C) of the Act, as
added by section 3132(a) of the Affordable Care Act, require hospices
to begin submitting quality data, based on measures to be 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 which fail to report quality data will have their market
basket update reduced by 2 percentage points.
Section 1814(a)(7)(D)(i) of the Act, as added by section 3132(b)(2)
of the Affordable Care Act, requires, 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 CY 2011
Home Health Prospective Payment System 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 Affordable Care Act, authorizes 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 Affordable Care Act 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
When the Medicare Hospice benefit was implemented, Congress
included an aggregate cap on hospice payments, which limits the total
aggregate payments any individual hospice can receive in a year.
Congress stipulated that a ``cap amount'' be computed each year. The
cap amount was set at $6,500 per beneficiary when first enacted in 1983
and has been adjusted annually by the change in the medical care
expenditure category of the consumer price index for urban consumers
from March 1984 to March of the cap year (section 1814(i)(2)(B) of the
Act). The cap year was defined as the period from November 1st to
October 31st. In the August 4, 2011 FY 2012 Hospice Wage Index final
rule (76 FR 47308 through 47314) for the 2012 cap year and
[[Page 52149]]
subsequent cap years, we announced that subsequently, the hospice
aggregate cap would be calculated using the patient-by-patient
proportional methodology. We allowed existing hospices the option of
having their cap calculated via the original streamlined methodology.
As of FY 2012, new hospices have their cap determinations calculated
using the patient-by-patient proportional methodology. The patient-by-
patient proportional methodology and the streamlined methodology are
two different methodologies for counting beneficiaries when calculating
the hospice aggregate cap. A detailed explanation of these methods is
found in the August 4, 2011 FY 2012 Hospice Wage Index final rule (76
FR 47308 through 47314). If a hospice's total Medicare reimbursement
for the cap year exceeds 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
When electing hospice, a beneficiary waives Medicare coverage for
any care for the terminal illness and related conditions except for
services provided by the designated hospice and attending physician.
The FY 2015 Hospice Wage Index and Payment Rate Update final rule (79
FR 50452) finalized a requirement that requires 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. This update to the beneficiary's status allows claims from
non-hospice providers to be processed and paid. Late filing of the NOE
can result in inaccurate benefit period data and leaves Medicare
vulnerable to paying non-hospice claims related to the terminal illness
and related conditions and beneficiaries possibly liable for any cost-
sharing associated costs. Upon live discharge or revocation, the
beneficiary immediately resumes the Medicare coverage that had been
waived when he or she elected hospice. The FY 2015 Hospice Wage Index
and Payment Rate Update final rule also finalized a requirement that
requires hospices to file a notice of termination/revocation within 5
calendar days of a beneficiary's live discharge or revocation, unless
the hospices have already filed a final claim. This requirement helps
to protect beneficiaries from delays in accessing needed care (Sec.
418.26(e)).
A hospice ``attending physician'' is described by the statutory and
regulatory definitions as a medical doctor, osteopath, or nurse
practitioner whom the beneficiary identifies, at the time of hospice
election, as having the most significant role in the determination and
delivery of his or her medical care. We received reports of problems
with the identification of the person's designated attending physician
and a third of hospice patients had multiple providers submit Part B
claims as the ``attending physician,'' using a claim modifier. The FY
2015 Hospice Wage Index and Payment Rate Update final rule 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
(79 FR 50479).
Hospice providers are required to begin using a Hospice Experience
of Care Survey for informal caregivers of hospice patients surveyed in
2015. The FY 2015 Hospice Wage Index and Payment Rate Update final rule
provided background and a description of the development of the Hospice
Experience of Care Survey, including the model of survey
implementation, the survey respondents, eligibility criteria for the
sample, and the languages in which the survey is offered. The FY 2015
Hospice Rate Update final rule also set out participation requirements
for CY 2015 and discussed vendor oversight activities and the
reconsideration and appeals process for entities that failed to win CMS
approval as vendors (79 FR 50496).
Finally, the FY 2015 Hospice Wage Index and Payment Rate Update
final rule required providers to complete their aggregate cap
determination not sooner than 3 months after the end of the cap year,
and not later than 5 months after, and remit any overpayments. Those
hospices that fail to timely submit their aggregate cap determinations
will have their payments suspended until the determination is completed
and received by the Medicare Administrative Contractor (MAC) (79 FR
50503).
8. IMPACT Act of 2014
The Improving Medicare Post-Acute Care Transformation Act of 2014
(Pub. L. 113-185) (IMPACT Act) 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 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 Rate Update final rule, 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 all subsequent days of hospice care (80 FR 47172). 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 Payment Rate Update final rule implemented
changes mandated by the IMPACT Act, in which the cap amount for
accounting years that end after September 30, 2016 and before October
1, 2025 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 FY, for FY 2017
and later (80 FR 47186). This allows for the timely implementation of
the IMPACT Act changes while better aligning the cap accounting year
with the timeframe described in the IMPACT Act.
Finally, the FY 2016 Hospice Wage Index and Payment Rate Update
final rule 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.
Reporting of all diagnoses on the hospice claim aligns with current
coding guidelines as
[[Page 52150]]
well as admission requirements for hospice certifications (80 FR
47142).
E. Trends in Medicare Hospice Utilization
Since the implementation of the hospice benefit in 1983, and
especially within the last decade, there has been substantial growth in
hospice benefit utilization. The number of Medicare beneficiaries
receiving hospice services has grown from 513,000 in FY 2000 to nearly
1.4 million in FY 2015. Similarly, Medicare hospice expenditures have
risen from $2.8 billion in FY 2000 to an estimated $15.5 billion in FY
2015.\3\ Under the economic assumptions from the 2017 Mid-Session
Review,\4\ our Office of the Actuary (OACT) projects that hospice
expenditures are expected to continue to increase, by approximately 7
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.
---------------------------------------------------------------------------
\3\ FY2000 figures from MedPAC analysis of the denominator file,
the Medicare Beneficiary Database, and the 100 percent hospice
claims standard analytic file from CMS (http://www.medpac.gov/documents/reports/chapter-11-hospice-services-(march-2012-
report).pdf?sfvrsn=4). FY 2015 hospice claims data from the Chronic
Conditions Data Warehouse (CCW), accessed on June 20, 2016.
\4\ ``Mid-Session Review: Budget of the US Government.'' Office
of Management and Budget. July 15, 2016. https://www.whitehouse.gov/sites/default/files/omb/budget/fy2017/assets/17msr.pdf.
---------------------------------------------------------------------------
There have also been changes in the diagnosis patterns among
Medicare hospice enrollees. Specifically, as described in Table 2,
there have been notable increases between 2002 and 2015 in
neurologically-based diagnoses, including various dementia and
Alzheimer's diagnoses. Additionally, there had been significant
increases in the use of non-specific, symptom-classified diagnoses,
such as ``debility'' and ``adult failure to thrive.'' In FY 2013,
``debility'' and ``adult failure to thrive'' were the first and sixth
most common hospice claims-reported diagnoses, respectively, accounting
for approximately 14 percent of all diagnoses. Effective October 1,
2014, hospice claims are returned to the provider if ``debility'' and
``adult failure to thrive'' are coded as the principal hospice
diagnosis as well as other ICD-9-CM (and as of October 1, 2015, ICD-10-
CM) codes that are not permissible as principal diagnosis codes per
ICD-9-CM (or ICD-10-CM) coding guidelines. In the FY 2015 Hospice Wage
Index and Payment Rate Update final rule (79 FR 50452), we reminded the
hospice industry that this policy would go into effect and claims would
start to be returned to the provider effective October 1, 2014. As a
result of this, there has been a shift in coding patterns on hospice
claims. For FY 2015, the most common hospice principal diagnoses were
Alzheimer's disease, Congestive Heart Failure, Lung Cancer, Chronic
Airway Obstruction, and Senile Dementia which constituted approximately
35 percent of all claims-reported principal diagnosis codes reported in
FY 2015. In Table 2 we have updated the information initially presented
in the FY 2017 proposed rule (81 FR 25504-06).
Table 2--The Top Twenty Principal Hospice Diagnoses, FY 2002, FY 2007, FY 2013, FY 2015
----------------------------------------------------------------------------------------------------------------
Reported principal
Rank ICD-9 diagnosis Count Percentage
----------------------------------------------------------------------------------------------------------------
Year: FY 2002
----------------------------------------------------------------------------------------------------------------
1............................. 162.9 Lung Cancer............... 73,769 11
2............................. 428.0 Congestive Heart Failure.. 45,951 7
3............................. 799.3 Debility Unspecified...... 36,999 6
4............................. 496 COPD...................... 35,197 5
5............................. 331.0 Alzheimer's Disease....... 28,787 4
6............................. 436 CVA/Stroke................ 26,897 4
7............................. 185 Prostate Cancer........... 20,262 3
8............................. 783.7 Adult Failure To Thrive... 18,304 3
9............................. 174.9 Breast Cancer............. 17,812 3
10............................ 290.0 Senile Dementia, Uncomp... 16,999 3
11............................ 153.0 Colon Cancer.............. 16,379 2
12............................ 157.9 Pancreatic Cancer......... 15,427 2
13............................ 294.8 Organic Brain Synd Nec.... 10,394 2
14............................ 429.9 Heart Disease Unspecified. 10,332 2
15............................ 154.0 Rectosigmoid Colon Cancer. 8,956 1
16............................ 332.0 Parkinson's Disease....... 8,865 1
17............................ 586 Renal Failure Unspecified. 8,764 1
18............................ 585 Chronic Renal Failure (End 8,599 1
2005).
19............................ 183.0 Ovarian Cancer............ 7,432 1
20............................ 188.9 Bladder Cancer............ 6,916 1
----------------------------------------------------------------------------------------------------------------
Year: FY 2007
----------------------------------------------------------------------------------------------------------------
1............................. 799.3 Debility Unspecified...... 90,150 9
2............................. 162.9 Lung Cancer............... 86,954 8
3............................. 428.0 Congestive Heart Failure.. 77,836 7
4............................. 496 COPD...................... 60,815 6
5............................. 783.7 Adult Failure To Thrive... 58,303 6
6............................. 331.0 Alzheimer's Disease....... 58,200 6
7............................. 290.0 Senile Dementia Uncomp.... 37,667 4
8............................. 436 CVA/Stroke................ 31,800 3
9............................. 429.9 Heart Disease Unspecified. 22,170 2
10............................ 185 Prostate Cancer........... 22,086 2
11............................ 174.9 Breast Cancer............. 20,378 2
12............................ 157.9 Pancreas Unspecified...... 19,082 2
13............................ 153.9 Colon Cancer.............. 19,080 2
[[Page 52151]]
14............................ 294.8 Organic Brain Syndrome NEC 17,697 2
15............................ 332.0 Parkinson's Disease....... 16,524 2
16............................ 294.10 Dementia In Other Diseases 15,777 2
w/o Behav. Dist.
17............................ 586 Renal Failure Unspecified. 12,188 1
18............................ 585.6 End Stage Renal Disease... 11,196 1
19............................ 188.9 Bladder Cancer............ 8,806 1
20............................ 183.0 Ovarian Cancer............ 8,434 1
----------------------------------------------------------------------------------------------------------------
Year: FY 2013
----------------------------------------------------------------------------------------------------------------
1............................. 799.3 Debility Unspecified...... 127,415 9
2............................. 428.0 Congestive Heart Failure.. 96,171 7
3............................. 162.9 Lung Cancer............... 91,598 6
4............................. 496 COPD..................... 82,184 6
5............................. 331.0 Alzheimer's Disease....... 79,626 6
6............................. 783.7 Adult Failure to Thrive... 71,122 5
7............................. 290.0 Senile Dementia, Uncomp... 60,579 4
8............................. 429.9 Heart Disease Unspecified. 36,914 3
9............................. 436 CVA/Stroke................ 34,459 2
10............................ 294.10 Dementia In Other Diseases 30,963 2
w/o Behavioral Dist.
11............................ 332.0 Parkinson's Disease....... 25,396 2
12............................ 153.9 Colon Cancer.............. 23,228 2
13............................ 294.20 Dementia Unspecified w/o 23,224 2
Behavioral Dist.
14............................ 174.9 Breast Cancer............. 23,059 2
15............................ 157.9 Pancreatic Cancer......... 22,341 2
16............................ 185 Prostate Cancer........... 21,769 2
17............................ 585.6 End-Stage Renal Disease... 19,309 1
18............................ 518.81 Acute Respiratory Failure. 15,965 1
19............................ 294.8 Other Persistent Mental 14,372 1
Dis.-classified elsewhere.
20............................ 294.11 Dementia In Other Diseases 13,687 1
w/Behavioral Dist.
----------------------------------------------------------------------------------------------------------------
Year: FY 2015
----------------------------------------------------------------------------------------------------------------
1............................. 331.0 Alzheimer's disease....... 196,705 13
2............................. 428.0 Congestive heart failure, 115,111 8
unspecified.
3............................. 162.9 Lung Cancer............... 88,404 6
4............................. 496 COPD...................... 80,655 6
5............................. 331.2 Senile degeneration of 46,843 3
brain.
6............................. 332.0 Parkinson's Disease....... 34,957 2
7............................. 429.9 Heart disease, unspecified 31,906 2
8............................. 436 CVA/Stroke................ 29,172 2
9............................. 437.0 Cerebral atherosclerosis.. 26,887 2
10............................ 174.9 Breast Cancer............. 23,969 2
11............................ 153.9 Colon Cancer.............. 23,844 2
12............................ 185 Prostate Cancer........... 23,293 2
13............................ 157.9 Pancreatic Cancer......... 23,127 2
14............................ 585.6 End stage renal disease... 22,990 2
15............................ 491.21 Obstructive chronic 21,493 1
bronchitis with (acute)
exacerbation.
16............................ 518.81 Acute respiratory failure. 20,214 1
17............................ 429.2 Cardiovascular disease, 16,937 1
unspecified.
18............................ 434.91 Cerebral artery 15,841 1
occlusion, unspecified
with cerebral infarction.
19............................ 414.00 Coronary atherosclerosis 15,689 1
of unspecified type of
vessel.
20............................ 188.9 Bladder Cancer............ 11,648 1
----------------------------------------------------------------------------------------------------------------
Note(s): The frequencies shown represent beneficiaries that had a least one claim with the specific ICD-9-CM
code reported as the principal diagnosis. Beneficiaries could be represented multiple times in the results if
they have multiple claims during that time period with different principal diagnoses.
Source: FY 2002 and 2007 hospice claims data from the Chronic Conditions Data Warehouse (CCW), accessed on
February 14 and February 20, 2013. FY 2013 hospice claims data from the CCW, accessed on June 26, 2014, and FY
2015 hospice claims data from the CCW, accessed on June 20, 2016.
While there has been a shift in the reporting of the principal
diagnosis as a result of diagnosis clarifications, a significant
proportion of hospice claims (49 percent) in FY 2014 only reported a
single principal diagnosis, which may not fully explain the
characteristics of Medicare beneficiaries who are approaching the end
of life. To address this pattern of single diagnosis reporting, the FY
2015 Hospice Wage Index and Payment Rate Update final rule (79 FR
50498) reiterated ICD-9-CM coding guidelines for the reporting of the
principal and additional diagnoses on the hospice claim. We reminded
providers to report all diagnoses on the hospice claim for the terminal
illness and related conditions, including those that affect the care
and clinical management for the beneficiary. Additionally, in the FY
2016 Hospice Wage Index and Payment Rate Update final rule (80 FR
47201), we provided further clarification regarding diagnosis reporting
on hospice claims. We clarified that hospices will report all
[[Page 52152]]
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 2015
hospice claims show that only 37 percent of hospice claims include a
single, principal diagnosis, with 63 percent submitting at least two
diagnoses and 46 percent including at least three.
F. Use of Health Information Technology
The Department of Health and Human Services (HHS) believes that the
use of certified health IT by hospices can help providers improve
internal care delivery practices and advance the interoperable exchange
of health information across care partners to improve communication and
care coordination. HHS has a number of initiatives designed to
encourage and support the adoption of health information technology and
promote nationwide health information exchange to improve health care.
The Office of the National Coordinator for Health Information
Technology (ONC) leads these efforts in collaboration with other
agencies, including CMS and the Office of the Assistant Secretary for
Planning and Evaluation (ASPE). In 2015, ONC released a document
entitled ``Connecting Health and Care for the Nation: A Shared
Nationwide Interoperability Roadmap'' (available at: https://www.healthit.gov/sites/default/files/hie-interoperability/nationwide-interoperability-roadmap-final-version-1.0.pdf), which includes a near-
term focus on actions that will enable a majority of individuals and
providers across the care continuum to send, receive, find and use a
common set of electronic clinical information at the nationwide level
by the end of 2017. The 2015 Edition Health IT Certification Criteria
(2015 Edition) builds on past rulemakings to facilitate greater
interoperability for several clinical health information purposes and
enables health information exchange through new and enhanced
certification criteria, standards, and implementation specifications.
The 2015 Edition also focuses on the establishment of an interoperable
nationwide health information infrastructure. More information on the
2015 Edition Final Rule is available at: https://www.healthit.gov/policy-researchers-implementers/2015-edition-final-rule
III. Provisions of the Proposed Regulations
The proposed rule, titled ``Medicare Program; FY 2017 Hospice
Payment Rate Update'' (81 FR 25497 through 25538), was published in the
Federal Register on April 28, 2016, with a comment period that ended on
June 20, 2016. In that proposed rule, we proposed to update the hospice
wage index, payment rates, and cap amount for fiscal year (FY) 2017. In
addition, the proposed rule proposed changes to the hospice quality
reporting program, including new quality measures. The proposed rule
also solicited feedback on an enhanced data collection instrument and
described plans to publicly display quality measures and other hospice
data beginning in the middle of 2017. Finally, the proposed rule
included information regarding the Medicare Care Choices Model (MCCM).
We received approximately 56 public comments on the proposed rule,
including comments from MedPAC, hospice agencies, national provider
associations, patient organizations, nurses, and advocacy groups.
In this final rule, we provide a summary of each proposed
provision, a summary of the public comments received and our responses
to them, and the policies we are finalizing for the FY 2017 Hospice
Payment Rate Update. Comments related to the paperwork burden are
addressed in the ``Collection of Information Requirements'' section in
this final rule. Comments related to the impact analysis are addressed
in the ``Economic Analyses'' section in this final rule.
A. Monitoring for Potential Impacts--Affordable Care Act Hospice Reform
In the FY 2017 Hospice Wage Index and Rate Update proposed rule (81
FR 25497), we provided a summary of analysis conducted on pre-hospice
spending, non-hospice spending, live discharge rates, and skilled
visits in the last days of life. In addition, we also provided a
summary of our plans to monitor for impacts of hospice payment reform.
We will continue to monitor the impact of future payment and policy
changes and will provide the industry with periodic updates on our
analysis in future rulemaking and/or announcements on the Hospice
Center Web page at: https://www.cms.gov/Center/Provider-Type/Hospice-Center.html.
We received several comments on the analysis and CMS's plans for
future monitoring efforts with regards to hospice payment reform
outlined in the proposed rule, which are summarized below.
Comment: A few commenters expressed concerns regarding whether pre-
hospice spending is an appropriate standard for comparison for post-
hospice spending for any diagnosis, including dementia. The commenters
noted the illness trajectory of dementia is marked by a slow,
progressive decline, differs from the illness trajectories of other
hospice appropriate diagnoses, and results in care needs increasing and
extending over longer periods of time. In turn, it may require higher
spending. The commenters asked us to recognize the overall care needs
of patients with dementia and other progressive neurological
conditions, and the costs associated with these patients and their
caregivers. Additionally, several commenters highlighted the challenges
of and intensive resources required for short-stay patients, noting
that the current payment system may not address the unique needs of
that population.
Several commenters suggested that CMS consider payment refinements
that help to incentivize appropriate timing on enrollment for hospice.
Additional commenters noted their concern regarding a potential case-
mix payment system for hospice, as the commenters believe that the
hospice benefit differs from all other Medicare payment systems, as it
is designed to account for the patient's full scope of Medicare needs.
With regards to non-hospice spending during a hospice election,
several commenters suggested that CMS take action to educate other
Medicare provider types in order to increase understanding of benefits
coverage and claims processing after a beneficiary has elected hospice.
Several commenters also suggested that CMS investigate options for
preventing other Medicare providers from billing without checking the
Common Working File and notifying the hospice for a determination as to
whether or not the care is related to the terminal prognosis. Several
commenters requested that a greater level of specificity for Part D
data be supplied to hospice providers, such that they can track where
the billing issues originate and begin to address them. The commenters
suggested that a coordinated system would help address the non-hospice
spending.
With regards to hospice live discharge rates, a few commenters
noted concerns about the difference between two types of live
discharges: A patient-initiated discharge or revocation versus a
hospice-initiated discharge. The commenters suggested that analysis of
live discharge rates should exclude the patient-initiated discharges or
revocations. Commenters suggested that for hospice-initiated
discharges, the reasons for such discharges should be reported so that
hospice providers can
[[Page 52153]]
make adjustments in their admission and discharge practices.
With regards to skilled visits during the last days of life, the
number of visits by RNs and social workers is anticipated to increase
during the last 7 days of a beneficiary's life as a result of the
service intensity add[hyphen]on payment, implemented on January 1,
2016. A few commenters stated that hospices take their cues from
patients and families, who should always have the option to decline a
visit. As such, decisions regarding visits made by the patient and
family ought to be considered and/or reflected in the data.
Finally, most commenters supported our planned analysis to monitor
the impact of hospice payment reform and would like to use the
monitoring results to target program integrity efforts to those
aberrant individual providers.
Although the analysis and monitoring efforts described in the
proposed rule did not relate to the timely filing requirement for the
hospice Notice of Election (NOE), nevertheless a few commenters
expressed concern about the timely filing requirement and lost revenue
due to data entry errors that cannot be immediately corrected.
Commenters encouraged CMS to continue to explore the possibility of
transmitting NOEs through Electronic Data Interchange rather than
through direct data entry and recommended that, in the meantime, when
the hospice files the NOE in good faith within the 5-day requirement,
but the MAC does not accept the NOE within 5 days, the payment for
hospice services should be allowed back to the date of election, once
the MAC has accepted the NOE.
Response: We appreciate these comments on the ongoing analysis
presented and will continue to monitor hospice trends and
vulnerabilities within the hospice benefit while also investigating
means by which we can educate the larger provider community regarding
appropriate billing practices. Additionally, we continue to explore
options and strategies for addressing and responding to concerning
behavior in the provider community. We will also consider these
suggestions in any potential future policy and payment refinements.
With regards to the comments received regarding the NOE timely
filing requirement, we recognize that inadvertent NOE errors, such as
transposed numbers or incorrect admission dates, will not trigger the
NOE to return to the hospice for correction. The hospice must wait
until the incorrect information is fully processed by Medicare systems
before they can correct it, and this could cause the NOE to be late. We
strongly encourage hospices to have quality assurance measures in place
regarding the accuracy of the NOE information to mitigate any potential
untimely NOEs. Our expectation is that the information provided on the
hospice NOE is accurate and free of transcribing errors. To aid in
reducing the impact of these situations on hospices, CMS is currently
conducting an analysis that aims to redesign the hospice benefit period
data in our systems.
B. FY 2017 Hospice Wage Index and Rate Update
1. FY 2017 Hospice Wage Index
a. Background
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 the Office of Management
and Budget (OMB) to the Metropolitan Statistical Areas (MSAs)
definitions.
We use the previous FY's hospital wage index data to calculate the
hospice wage index values. For FY 2017, the hospice wage index will be
based on the FY 2016 pre-floor, pre-reclassified hospital wage index.
This means that the hospital wage data used for the hospice wage index
is 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 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 Inpatient Respite Care (IRC).
In the FY 2006 Hospice Wage Index final rule (70 FR 45130), we
adopted the changes discussed in the OMB Bulletin No. 03-04 (June 6,
2003). This bulletin announced revised definitions for MSAs and the
creation of micropolitan statistical areas and combined statistical
areas. The bulletin is available online at http://www.whitehouse.gov/omb/bulletins/b03-04.html. When adopting OMB's new labor market
designations in FY 2006, we identified some geographic areas where
there were no hospitals, and thus, no hospital wage index data, on
which to base the calculation of the hospice wage index. In the FY 2010
Hospice Wage Index final rule (74 FR 39386), we adopted the policy that
for urban labor markets without a hospital from which hospital wage
index data could be derived, all of the 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.
In FY 2016, the only CBSA without a hospital from which hospital wage
data could be derived is 25980, Hinesville-Fort Stewart, Georgia.
In the FY 2008 Hospice Wage Index final rule (72 FR 50214), we
implemented a new methodology to update the hospice wage index for
rural areas without a hospital, and thus no hospital wage data. In
cases where there was a rural area without rural hospital wage data, we
used 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, our policy of
imputing a rural pre-floor, pre-reclassified hospital wage index value
based on the pre-floor, pre-reclassified hospital wage index (or
indices) of CBSAs contiguous to a rural area without a hospital from
which hospital wage data could be derived does not recognize the unique
circumstances of Puerto Rico. In this final rule, for FY 2017, we will
continue to use the most recent pre-floor, pre-reclassified hospital
wage index value available for Puerto Rico, which is 0.4047.
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 then 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,
[[Page 52154]]
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.
b. FY 2016 Implementation of New Labor Market Delineations
OMB has published subsequent bulletins regarding CBSA changes. On
February 28, 2013, OMB issued OMB Bulletin No. 13-01, announcing
revisions to the delineation of MSAs, Micropolitan Statistical Areas,
and Combined Statistical Areas, and guidance on uses of the delineation
in these areas. A copy of this bulletin is available online at: http://www.whitehouse.gov/sites/default/files/omb/bulletins/2013/b-13-01.pdf.
This bulletin states that it ``provides the delineations of all
Metropolitan Statistical Areas, Metropolitan Divisions, Micropolitan
Statistical Areas, Combined Statistical Areas, and New England City and
Town Areas in the United States and Puerto Rico based on the standards
published on June 28, 2010, in the Federal Register (75 FR 37246
through 37252) and Census Bureau data.'' In the FY 2016 Hospice Wage
Index final rule (80 FR 47178), we adopted the OMB's new area
delineations using a 1-year transition. In the FY 2016 Hospice Wage
Index and Payment Rate Update final rule (80 FR 47178), we stated that
beginning October 1, 2016, the wage index for all hospice payments
would be fully based on the new OMB delineations.
A summary of the comments we received regarding the wage index and
our responses to those comments appears below.
Comment: Several commenters noted their support for the full
adoption of the new labor market delineations.
Response: We appreciate the comments in support of the CBSA
delineations finalized in last year's FY 2016 Hospice Wage Index and
Payment Rate Update final rule (80 FR 47142).
Comment: One commenter disagreed with fully basing hospice
geographic area wage adjustments on the new OMB delineations. The
commenter was particularly concerned with the New York City CBSA and
the fact that the CBSA contains counties from New Jersey.
Response: In the FY 2016 Hospice Wage Index and Rate Update final
rule (80 FR 47178), we stated that a 1-year transition policy would
apply to the FY 2016 payment rates and that, beginning in FY 2017,
hospice payments would be fully-based on the new OMB delineations. In
addition, we believe that the OMB's CBSA designations reflect the most
recent available geographic classifications and are a reasonable and
appropriate method of defining geographic areas for the purposes of
wage adjusting the hospice payment rates. We do not see any compelling
reason to deviate from the OMB designations.
Comment: A commenter was concerned with the continued use of the
pre-floor, pre-reclassified hospital wage index to adjust the hospice
payment rates, because this causes continuing volatility of the hospice
wage index from one year to the next. The commenter believes that this
volatility is often based on inaccurate or incomplete hospital cost
report data.
Response: We believe that annual changes in the wage index reflect
real variations in costs of providing care in various geographic
locations. The wage index values are based on data submitted on the
inpatient hospital cost reports. 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 paid under the Inpatient Prospective Payment System
(IPPS). All 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. We
believe that our review processes result in an accurate reflection of
the applicable wages for the areas given.
In addition, we believe that finalizing our proposal to adopt a
hospice wage index standardization factor will provide 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: A commenter was concerned with the lack of parity between
different health care sectors, each of which utilizes some form of a
hospital wage index, that experience differing wage index values for
specific geographic areas. The commenter also stated that hospital
reclassifications create labor market distortions in areas in which
hospice costs are not reclassified.
Response: Several post-acute care payment systems utilize the pre-
floor, pre-reclassified hospital wage index as the basis for their wage
indexes (for example, the Home Health Prospective Payment System (HH
PPS), the Skilled Nursing Facility Prospective Payment System (SNF PPS)
and the Inpatient Rehabilitation Facility Prospective Payment System
(IRF PPS)). The statutes that govern hospice payment do not provide any
discretion to permit a mechanism for allowing hospices to seek
geographic reclassification. The reclassification provision is found in
section 1886(d)(10) of the Act. Section 1886(d)(10)(C)(i) of the Act
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 at 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
the data may or may not apply to a given hospice in a given instance.
Comment: One commenter requested that CMS modify the wage index so
that the area wage index applicable to any hospice that is located in
an urban area of a state may not be less than the area wage index
applicable to hospices located in rural areas in that State.
Response: 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 previous year's 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 (SNF PPS, IRF PPS, HH PPS, etc.).
Comment: A commenter requested that CMS explore a wholesale
revision and reform of the hospice wage index.
Response: We are exploring other methodologies for future reform of
the Medicare wage index. CMS' ``Report to Congress: Plan to Reform the
Medicare Wage Index'' was submitted by the Secretary on April 11, 2012
and is available on our Wage Index Reform Web page at: https://
www.cms.gov/Medicare/Medicare-Fee-for-Service-
[[Page 52155]]
Payment/AcuteInpatientPPS/Wage-Index-Reform.html.
Final Action: 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 pre-floor, pre-reclassified hospital
inpatient wage index as the wage adjustment to the labor portion of the
hospice rates. For FY 2017, the updated wage data are for hospital cost
reporting periods beginning on or after October 1, 2011 and before
October 1, 2012 (FY 2012 cost report data).
The wage index applicable for FY 2017 is available on the CMS Web
site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/index.html. As of FY 2012, the wage index values applicable for
the upcoming fiscal year and subsequent fiscal years are no longer
published in the Federal Register (77 FR 44242). The hospice wage index
for FY 2017 will be effective October 1, 2016 through September 30,
2017.
2. Hospice Payment Update Percentage
Section 4441(a) of the Balanced Budget Act of 1997 (BBA) 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 index
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 for that FY. The Act requires us to use the inpatient
hospital market basket to determine the hospice payment rate update. In
addition, section 3401(g) of the Affordable Care Act mandates that,
starting with FY 2013 (and in subsequent FYs), the hospice payment
update percentage will be annually reduced by changes in economy-wide
productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act.
The statute defines the productivity adjustment to be equal to the 10-
year moving average of changes in annual economy-wide private nonfarm
business multifactor productivity (MFP) (as projected by the Secretary
for the 10-year period ending with the applicable FY, year, cost
reporting period, or other annual period) (the ``MFP adjustment''). A
complete description of the MFP projection methodology is available on
our Web site at: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch.html.
In addition to the MFP adjustment, section 3401(g) of the
Affordable Care Act also mandates that in FY 2013 through FY 2019, the
hospice payment update percentage will be reduced by an additional 0.3
percentage point (although for FY 2014 to FY 2019, the potential 0.3
percentage point reduction is subject to suspension under conditions
specified in section 1814(i)(1)(C)(v) of the Act). The hospice payment
update percentage for FY 2017 is based on the estimated inpatient
hospital market basket update of 2.7 percent (based on IHS Global
Insight, Inc.'s second quarter 2016 forecast with historical data
through the first quarter of 2016). 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 2017 of 2.7 percent must
be reduced by a MFP adjustment as mandated by Affordable Care Act
(currently estimated to be 0.3 percentage point for FY 2017). The
estimated inpatient hospital market basket update for FY 2017 is
reduced further by 0.3 percentage point, as mandated by the Affordable
Care Act. In effect, the hospice payment update percentage for FY 2017
is 2.1 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.
A summary of the comments we received regarding the payment rates
and our responses to those comments appear below.
Comment: Several commenters noted their support of the hospice
payment update percentage.
Response: We appreciate the comments in support of the hospice
payment update percentage.
Comment: One commenter suggested the CMS eliminate the hospice
payment update percentage to hospice payments for FY 2017, as the
commenter maintains that payment adequacy for hospice providers is
generally positive. Other commenters noted that the proposed hospice
payment update percentage is not sufficient to keep pace with rising
costs of providing hospice care and suggested that CMS revisit the
proposed hospice payment update percentage for potential increase.
Response: The payment update percentage to the hospice rates is
required by statute, as previously described in detail in this section,
and we do not have regulatory authority to alter the payment update.
Final Action: We are implementing the hospice payment update
percentage as discussed in the proposed rule. Based on IHS Global
Insight, Inc.'s updated forecast, the hospice payment update percentage
for FY 2017 will be 2.1 percent for hospices that submit the required
quality data and 0.1 percent for hospices that do not submit the
required quality data.
3. FY 2017 Hospice Payment Rates
There are four payment categories that 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
continuous home care, IRC, or general inpatient care. CHC is provided
during a period of patient crisis to maintain the person at home; IRC
is short-term care to allow the usual caregiver to rest and be relieved
from caregiving; and General Inpatient Care (GIP) is to treat symptoms
that cannot be managed in another setting.
As discussed in the FY 2016 Hospice Wage Index and Payment 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 the final rule, we adopted a
Service Intensity Add-on (SIA) payment, 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. 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 Payment 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
[[Page 52156]]
rates. The SBNF will be calculated for each FY using the most current
and complete FY utilization data available at the time of rulemaking.
For FY 2017, the budget neutrality adjustment that applies to days 1
through 60 is calculated to be 1.0000. The budget neutrality adjustment
that applies to days 61 and beyond is calculated to be 0.9999.
For FY 2017, we are applying a wage index standardization factor to
the FY 2017 hospice payment rates in order to ensure overall budget
neutrality when updating the hospice wage index with more recent
hospital wage data. Wage index standardization factors are applied in
other payment settings such as under home health Prospective Payment
System (PPS), IRF PPS, and SNF PPS. Applying a wage index
standardization factor to hospice payments will eliminate the aggregate
effect of annual variations in hospital wage data. We believe that
adopting a hospice wage index standardization factor will provide 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.
To calculate the wage index standardization factor, we simulated total
payments using the FY 2017 hospice wage index and compared it to our
simulation of total payments using the FY 2016 hospice wage index. By
dividing payments for each level of care using the FY 2017 wage index
by payments for each level of care using the FY 2016 wage index, we
obtain a wage index standardization factor for each level of care (RHC
days 1-60, RHC days 61+, CHC, IRC, and GIP).
Lastly, the hospice payment rates for hospices that submit the
required quality data will be increased by the full FY 2017 hospice
payment update percentage of 2.1 percent as discussed in section
III.C.3 of this final rule. The FY 2017 RHC rates are shown in Table
11. The FY 2017 payment rates for CHC, IRC, and GIP are shown in Table
12.
Table 11--FY 2017 Hospice RHC Payment Rates
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2017
Wage index hospice
Code Description FY 2016 SBNF standardization payment FY 2017
payment rates factor update payment rates
percentage
--------------------------------------------------------------------------------------------------------------------------------------------------------
651.................................. Routine Home Care (days 1-60).. $186.84 x 1.0000 x 0.9989 x 1.021 $190.55
651.................................. Routine Home Care (days 61+)... 146.83 x 0.9999 x 0.9995 x 1.021 149.82
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 12--FY 2017 Hospice CHC, IRC, and GIP Payment Rates
----------------------------------------------------------------------------------------------------------------
FY 2017
Wage index hospice
Code Description FY 2016 standardization payment FY 2017
payment rates factor update payment rates
percentage
----------------------------------------------------------------------------------------------------------------
652...................... Continuous Home $944.79 x 1.0000 x 1.021 $964.63
Care.
Full Rate = 24
hours of care..
$40.19 = FY 2017
hourly rate..
655...................... Inpatient Respite 167.45 x 1.0000 x 1.021 170.97
Care.
656...................... General Inpatient 720.11 x 0.9996 x 1.021 734.94
Care.
----------------------------------------------------------------------------------------------------------------
Sections 1814(i)(5)(A) through (C) of the Act require that hospices
begin submitting 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
(HQRP), 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 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 with respect to that FY. The FY 2017 rates for
hospices that do not submit the required quality data will be updated
by the FY 2017 hospice payment update percentage of 2.1 percent minus 2
percentage points. These rates are shown in Tables 13 and 14.
Table 13--FY 2017 Hospice RHC Payment Rates for Hospices That DO NOT Submit the Required Quality Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2017
hospice
Wage index payment
Code Description FY 2016 SBNF standardization update of 2.1% FY 2017
payment rates factor minus 2 payment rates
percentage
points = 0.1%
--------------------------------------------------------------------------------------------------------------------------------------------------------
651.................................. Routine Home Care (days 1-60).. $186.84 x 1.0000 x 0.9989 x 1.001 $186.82
651.................................. Routine Home Care (days 61+)... 146.83 x 0.9999 x 0.9995 x 1.001 146.89
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 52157]]
Table 14--FY 2017 Hospice CHC, IRC, and GIP Payment Rates for Hospices That DO NOT Submit the Required Quality
Data
----------------------------------------------------------------------------------------------------------------
FY 2017
hospice
Wage index payment
Code Description FY 2016 standardization update of 2.1% FY 2017
payment rates factor minus 2 payment rates
percentage
points = 0.1%
----------------------------------------------------------------------------------------------------------------
652...................... Continuous Home $944.79 x 1.0000 x 1.001 $945.73
Care.
Full Rate = 24
hours of care..
$39.41 = FY 2017
hourly rate..
655...................... Inpatient Respite 167.45 x 1.0000 x 1.001 167.62
Care.
656...................... General Inpatient 720.11 x 0.9996 x 1.001 720.54
Care.
----------------------------------------------------------------------------------------------------------------
A summary of the comments we received regarding the payment rates
and our responses to those comments appear below.
Comment: A commenter asked if the application of the
standardization factor is premature or is it part of the continued
progression of hospice reimbursement from hybrid fee-for-service/health
maintenance organization to a full case-mix or value-based purchasing
(VBP) system.
Response: We believe that applying a wage index standardization
factor to the hospice rates is appropriate. The application of the
standardization factor will mitigate any potential effects due to the
annual variations in hospital wage data. Moreover, this approach
creates a level of protection for the Medicare program as well as to
hospices, as it minimizes the impacts of any fluctuations in the wage
index.
Comment: Several commenters requested that the SIA Payment
eligibility requirements be modified to include additional hospice
services, including visits from licensed practical nurses (LPNs), music
therapists, and other professionals providing care during the last 7
days of life. In addition, several commenters requested that data be
collected in order to determine if the SIA Payment increased the number
of visits during beneficiaries' most intensive time of need for skilled
care (specifically, the last 7 days of life).
Response: CMS finalized the SIA payment policy in the FY 2016
Hospice Wage Index and Payment Update final rule (80 FR 47141) and we
did not solicit comments on a proposal to modify these policy
parameters in the FY 2017 Hospice Wage Index and Payment Rate update
proposed rule (81 FR 25498). However, we will continue to consider and
monitor for potential refinements to this policy, including current
monitoring efforts that were described in the FY 2017 Hospice Wage
Index and Payment Rate Update proposed rule (81 FR 25498) in response
to these policy changes, and we will take these comments into account
as we continue to do so.
Comment: One commenter noted that there have been issues with the
technical implementation of the SIA payment such that payment
adjustments are not occurring as originally intended.
Response: While the technical implementations issues with regards
to SIA payments have been minimal, we appreciate this comment and are
working diligently with appropriate stakeholders to expedite the
appropriate system remediation to ensure accurate payment to providers.
Comment: One commenter expressed concern that the RHC rate payment
amount for Days 61 and beyond may lead to payment inadequacy for
patients with long lengths of stay. One commenter noted that the
episode gap required by the two RHC rates policy implemented for FY
2016 could have a negative impact on those hospices that accept
patients via transfers. Moreover, the commenter noted that CMS should
consider payment adjustments if a patient is transferred from one
hospice to another, particularly at or near day 61 of a hospice
episode.
Response: We appreciate the comments and the concern for
appropriate payment for long stay beneficiaries as well as transfer
patients. The creation of the two RHC rates (one for days 1-60 and a
another for days 61 and beyond) was finalized in the FY 2016 Hospice
Wage Index and Payment Rate Update final rule (80 FR 47141), and we did
not propose any changes for FY 2017 nor did we solicit comments on any
future changes. In response to public comments, we stated in the FY
2016 Hospice Wage Index and Payment Rate Update final rule that
allowing for a higher payment for a new hospice election (or in
transfer situations) without a gap in hospice care of greater than 60
days goes against our intent to mitigate the incentive to discharge and
readmit patients (or transfer patients) at or around day 60 for the
purposes of obtaining a higher payment (80 FR 47168). With regards to
the commenter's concern regarding reimbursement for long lengths of
stay, we refer the commenter to the FY 2016 Hospice Wage Index and
Payment Rate Update final rule (80 FR 47142), where we discuss the
rationale for the creation of a higher RHC rate for days 1-60 and a
lower rate for days 61 and beyond. In that final rule, we noted that
hospice stays manifest in a `U-Shaped' pattern (that is, the intensity
of services provided is higher both at admission and near death and,
conversely, is relatively lower during the middle period of the hospice
episode). Since hospice care is most profitable during the long, low-
cost middle portions of an episode, longer episodes have very
profitable, long middle segments (80 FR 47161). Therefore, in order to
better align hospice payments with service intensity during a hospice
episode of care, we implemented a higher RHC rate for days 1-60 and a
lower rate for days 61 and beyond, effective January 1, 2016. We also
implemented a service intensity add-on (SIA) payment policy that
reimburses hospices for visits performed during the last 7 days of a
beneficiary's life (in addition to RHC per diem payments), also
effective January 1, 2016. We will continue to monitor for and consider
potential refinements to these policies as appropriate.
Comment: A commenter noted that Medicaid agencies have encountered
challenges in the implementation of the payment changes due to hospice
reform.
Response: We appreciate this comment and are working diligently
with appropriate stakeholders and State Agencies to facilitate
effective implementation of hospice payment reform.
Final Action: We are implementing the updates to hospice payment
rates as discussed in the proposed rule.
[[Page 52158]]
4. Hospice Cap Amount for FY 2017
As discussed in the FY 2016 Hospice Wage Index and Payment Rate
Update final rule (80 FR 47183), we implemented changes mandated by the
Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT
Act). 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 consumer price
index for urban consumers (CPI-U). As required by section
1814(i)(2)(B)(ii) of the Act, the hospice cap amount for the 2016 cap
year, starting on November 1, 2015 and ending on October 31, 2016, is
equal to the 2015 cap amount ($27,382.63) updated by the FY 2016
hospice payment update percentage of 1.6 percent. As such, the 2016 cap
amount is $27,820.75.
In the FY 2016 Hospice Wage Index and Payment Rate Update final
rule (80 FR 47142), we finalized aligning the cap accounting year with
the federal FY beginning in 2017. Therefore, the 2017 cap year will
start on October 1, 2016 and end on September 30, 2017. Table 26 in the
FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR
47185) outlines the timeframes for counting beneficiaries and payments
during the 2017 transition year. The hospice cap amount for the 2017
cap year will be $28,404.99, which is equal to the 2016 cap amount
($27,820.75) updated by the FY 2017 hospice payment update percentage
of 2.1 percent.
A summary of public comments and our responses to comments on the
hospice cap are summarized below:
Comment: One commenter expressed concerns that the methodology used
to calculate the hospice cap creates an incentive for rural hospices to
inflate their utilization of the GIP level of care, as some rural
hospices may do this to gain higher reimbursement by placing patients
at the GIP level of care that may not qualify for that level of care.
Response: The hospice aggregate cap is calculated based on total
reimbursement across all levels of care. In addition, the hospice
inpatient cap limits total payments to the hospice for inpatient care
(general or respite). Total payments are subject to a limitation that
total inpatient care days for Medicare patients does not exceed 20
percent of the total days for which patients had elected hospice care.
We urge providers to adhere to appropriate guidelines with respect to
the hospice levels of care. We note that in a March 2016 Office of
Inspector General (OIG) report, OIG found that hospices billed one-
third of GIP stays inappropriately, costing Medicare $268 million in
2012. According to the report, ``hospices commonly billed for GIP when
the beneficiary did not have uncontrolled pain or unmanaged symptoms.''
(http://oig.hhs.gov/oei/reports/oei-02-10-00491.asp) As such, we will
continue to monitor the use of the various levels of care in order to
identify any aberrant or problematic behavior.
Final Action: We are implementing the changes to the hospice cap
amount as discussed in the proposed rule.
C. Proposed Updates to the Hospice Quality Reporting Program (HQRP)
1. Background and Statutory Authority
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 FY involved. Any such reduction would not
be cumulative or 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. General Considerations Used for Selection of Quality Measures for
the HQRP
Any measures selected by the Secretary must be endorsed by the
consensus-based entity, which holds a contract regarding performance
measurement, including the endorsement of quality measures, with the
Secretary under section 1890(a) of the Act. This contract is currently
held by the National Quality Forum (NQF). However, section
1814(i)(5)(D)(ii) of the Act provides that in the case of a specified
area or medical topic determined appropriate by the Secretary for which
a feasible and practical measure has not been endorsed by the
consensus-based entity, the Secretary may specify measures that are not
so endorsed as long as due consideration is given to measures that have
been endorsed or adopted by a consensus-based organization identified
by the Secretary. Our paramount concern is the successful development
of an HQRP that promotes the delivery of high quality healthcare
services. We seek to adopt measures for the HQRP that promote person-
centered, high quality, and safe care. Our measure selection activities
for the HQRP take into consideration input from the Measure
Applications Partnership (MAP), convened by the NQF, as part of the
established CMS pre-rulemaking process required under section 1890A of
the Act. The MAP is a public-private partnership comprised of multi-
stakeholder groups convened by the NQF for the primary purpose of
providing input to CMS on the selection of certain categories of
quality and efficiency measures, as required by section 1890A(a)(3) of
the Act. By February 1st of each year, the NQF must provide that input
to CMS. Input from the MAP is located at http://www.qualityforum.org/Setting_Priorities/Partnership/Measure_Applications_Partnership.aspx.
We also take into account national priorities, such as those
established by the National Priorities Partnership at (http://www.qualityforum.org/npp/), the HHS Strategic Plan (http://www.hhs.gov/secretary/about/priorities/priorities.html), the National Strategy for
Quality Improvement in Healthcare, (http://www.ahrq.gov/workingforquality/nqs/nqs2013annlrpt.htm) and the CMS Quality Strategy
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.html). To
the extent practicable, we have sought to adopt measures endorsed by
member organizations of the National Consensus Project (NCP),
recommended by multi-stakeholder organizations, and developed with the
input of providers, purchasers and/or payers, and other stakeholders.
3. Policy for Retention of HQRP Measures Adopted for Previous Payment
Determinations
For the purpose of streamlining the rulemaking process, we
finalized our policy in the FY 2016 Hospice Wage Index final rule (80
FR 47187) that when we adopt measures for the HQRP beginning with a
payment
[[Page 52159]]
determination year, these measures would automatically be adopted for
all subsequent years' payment determinations, unless we proposed to
remove, suspend, or replace the measures. Quality measures would be
considered for removal by CMS for reasons including, but not limited
to:
Measure performance among hospices was so high and
unvarying that meaningful distinction in improvements in performance
could no longer be made;
Performance or improvement on a measure did not result in
better patient outcomes;
A measure did not align with current clinical guidelines
or practice;
A more broadly applicable measure (across settings,
populations, or conditions) for the particular topic was available;
A measure that was more proximal in time to desired
patient outcomes for the particular topic was available;
A measure that was more strongly associated with desired
patient outcomes for the particular topic was available; or
Collection or public reporting of a measure led to
negative unintended consequences.
For any such removal, the public would be given an opportunity to
comment through the annual rulemaking process. However, if there were
reason to believe continued collection of a measure raised potential
safety concerns, we would take immediate action to remove the measure
from the HQRP and not wait for the annual rulemaking cycle. The
measures would be promptly removed, and we would immediately notify
hospices and the public of such a decision through the usual CMS HQRP
communication channels, including postings and announcements on the CMS
HQRP Web site, Medicare Learning Network (MLN) eNews communications,
national provider association calls, and announcements on Open Door
Forums and Special Open Door Forums. In such instances, the removal of
a measure would be formally announced in the next annual rulemaking
cycle.
To further streamline the rulemaking process, we proposed to codify
that if measures we are using in the HQRP have non-substantive changes
in their specifications change as part of their NQF endorsement
process, we would continue to utilize the measure with their new
endorsed status in the HQRP. As mentioned previously, quality measures
selected for the HQRP must be endorsed by the NQF unless they meet the
statutory criteria for exception under section 1814(i)(5)(D)(ii) of the
Act. The NQF is a voluntary consensus standard-setting organization
with a diverse representation of consumer, purchaser, provider,
academic, clinical, and other healthcare stakeholder organizations. The
NQF was established to standardize healthcare quality measurement and
reporting through its consensus measure development process (http://www.qualityforum.org/About_NQF/Mission_and_Vision.aspx). The NQF
undertakes review of: (a) New quality measures and national consensus
standards for measuring and publicly reporting on performance, (b)
regular maintenance processes for endorsed quality measures, (c)
measures with time-limited endorsement for consideration of full
endorsement, and (d) ad hoc review of endorsed quality measures,
practices, consensus standards, or events with adequate justification
to substantiate the review. Through NQF's measure maintenance process,
NQF-endorsed measures are sometimes updated to incorporate changes that
we believe do not substantially change the nature of the measure.
Examples of such changes could be updated diagnosis or procedure codes,
changes to exclusions to a particular patient/consumer population, or
definitions. We believe these types of maintenance changes are distinct
from more substantive changes to measures. Additionally, since the NQF
endorsement and measure maintenance process is one that ensures
transparency, public input, and discussion among representatives across
the healthcare enterprise,\5\ we believe that the NQF measure
endorsement and maintenance process itself is transparent,
scientifically rigorous, and provides opportunity for public input.
Thus, we proposed to codify at Sec. 418.312 that if the NQF makes only
non-substantive changes to specifications for HQRP measures in the
NQF's re-endorsement process, we would continue to utilize the measure
in its new endorsed status. If NQF-endorsed specifications change and
we do not adopt those changes, then we would propose the measure as an
application. An application of a NQF-endorsed quality measure is
utilized in instances when CMS has identified a need to use a NQF-
endorsed measure in a QRP but need to use it with one or more
modifications to the quality measure's specifications. These
modifications pertain to, but are not limited to, one or more of the
following aspects of a NQF-endorsed quality measure: (a) Numerator, (b)
denominator, (c) setting, (d) look-back period, (e) calculation period,
(f) risk adjustment, and (g) revisions to data elements used to collect
the data required for the measure, etc. CMS may adopt a quality measure
for the HQRP under section 1814(i)(5)(D)(ii) of the Act, which states,
``In the case of a specified area or medical topic determined
appropriate by the Secretary for which a feasible and practical measure
has not been endorsed by [the NQF], the Secretary may specify a measure
that is not so endorsed as long as due consideration is given to
measures that have been endorsed or adopted by a consensus organization
identified by the Secretary.'' Reasons for not adopting changes in
measure specifications to a measure may include any of the
aforementioned criteria in this section, including that the new
specification does not align with clinical guidelines or practice or
that the new specification leads to negative unintended consequences.
Finally, we will continue to use rulemaking to adopt substantive
updates made by the NQF to the endorsed measures we have adopted for
the HQRP. We continue to make these determinations about what
constitutes a substantive versus non-substantive change on a measure-
by-measure basis. A change would be deemed substantive if the intent of
the measure changes, the facility/setting changes, the data sources
changes, the level of analysis changes, and/or the measure is removed.
We will continue to provide updates about changes to measure
specifications as a result of NQF endorsement or maintenance processes
through the normal CMS HQRP communication channels, including postings
and announcements on the CMS HQRP Web site, MLN eNews communications,
national provider association calls, and announcements on Open Door
Forums and Special Open Door Forums.
---------------------------------------------------------------------------
\5\ ``NQF: How Endorsement Happens--National Quality Forum.''
2010. 26 Jan. 2016 http://www.qualityforum.org/Measuring_Performance/ABCs/How_Endorsement_Happens.aspx.
---------------------------------------------------------------------------
Comment: CMS received two comments on our proposal to codify that
if measures used in the HQRP undergo non-substantive changes as part of
their NQF re-endorsement process, we would utilize the measure with
their new endorsed status without going through a new notice-and-
comment rulemaking process. One commenter supported the proposal to
codify this policy. Another commenter was concerned that CMS's plan to
adopt non-substantive change(s) approved through the NQF re-endorsement
process without a notice-and-comment rulemaking process does not allow
providers and vendors the
[[Page 52160]]
opportunity to provide input on changes to measure specifications.
Additionally, the commenter also had concerns that adopting non-
substantive changes to measures outside of the rulemaking process would
limit the ability for hospices and vendors to make necessary changes to
data collection systems to implement non-substantive updates to
measures.
Response: We thank commenters for their support of this proposal,
and for their concerns raised. We agree that the opportunity for the
public to provide input on all changes to measure specifications (both
substantive and non-substantive) is vital to the measure development,
endorsement, and maintenance process. We also agree with the commenter
that vendors and the hospice community need ample time to implement
changes to measure specifications, especially those that would warrant
updates to Hospice Item Set (HIS) items or technical specifications. We
would like to reassure commenters that, as stated in this rule, we will
still propose substantive changes to measure through rulemaking. With
regard to non-substantive measure changes that could occur as a result
of the measure maintenance and re-endorsement process, we would like to
clarify that the NQF processes for endorsement and maintenance of
measures includes review by an expert Standing Committee, public and
Member comment periods, Member voting, consideration by the Consensus
Standards Approval Committee (CSAC), endorsement by the Board of
Directors, and a 30-day appeals period. The NQF endorsement and
maintenance (re-endorsement) process allows ample opportunity for NQF
member and public input, during the measure development, endorsement
and maintenance phases. We encourage hospices to participate in these
NQF comment periods to offer their insights about potential impacts of
changes to measures and measure specifications. We believe that in
instances of non-substantive changes to measure specifications,
maximizing the use of NQF opportunities for public input allows us to
efficiently and expediently adopt non-substantive, but important
changes to measures. Regarding the commenter's concern about whether
this policy will allow providers ample time to implement and adopt non-
substantive changes, we would like to point out that when non-
substantive changes put forth by the NQF are adopted, we are not
required to immediately implement those changes on the date of re-
endorsement by NQF. Once a non-substantive change is endorsed by NQF,
we will consider the time necessary for providers and vendors to
implement the change. If newly endorsed non-substantive changes require
updates to data collection mechanisms (for example, updates to HIS
specifications) or associated training materials, we will allow ample
time for providers and vendors to prepare and implement such changes.
As noted in the rule, we will communicate the endorsement of non-
substantive changes, decisions about whether to adopt non-substantive
changes, and timeline for implementation of non-substantive changes
through regular HQRP communication channels. Additionally, CMS welcomes
comment on any non-substantive changes adopted under this mechanism
through the appropriate sub-regulatory communication channels,
including but not limited to: NQF public comment periods held as part
of endorsement processes, feedback from providers on the Hospice
Quality HelpDesk, and feedback from the provider community on ODFs and
SODFs. CMS will make such comments and their responses available to the
public under the appropriate sub-regulatory communication channels.
Finally, we would like to note that this policy is consistent with
similar policies in other QRPs.
Comment: We received a few comments on our previously finalized
policy for measure retention. These commenters encouraged CMS's
continued consideration of whether previously adopted quality measures
are appropriate for retention in the HQRP. Commenters encouraged CMS to
eliminate measures that are no longer considered to effectively measure
quality.
Response: We thank commenters for their suggestions surrounding
measure retention and removal. We agree that any quality measures
proposed and retained in the HQRP should continue to provide meaningful
data to providers and consumers on quality of care. We regularly
conduct measure testing activities according to NQF guidelines and the
Blueprint for the CMS Measures Management System Version 12.0 (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint-120.pdf) to ensure that measures
continue to 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 outlined in this section of the rule, we will
propose a measure for removal if meaningful distinctions in quality of
care can no longer be made from the measure due to high and unvarying
performance.
Final Action: After consideration of the comments, we are codifying
our policy that once a quality measure is adopted, it be retained for
use in the subsequent fiscal year payment determinations until
otherwise stated, as proposed.
4. Previously Adopted Quality Measures for FY 2017 and FY 2018 Payment
Determination
As stated in the CY 2013 HH PPS final rule (77 FR 67068 through
67133), CMS expanded the set of required measures to include additional
measures endorsed by NQF. We also stated that to support the
standardized collection and calculation of quality measures by CMS,
collection of the needed data elements would require a standardized
data collection instrument. In response, CMS developed, tested, and
implemented a hospice patient-level item set, the HIS. Hospices are
required to submit a HIS-Admission record and a HIS-Discharge record
for each patient admission to hospice since July 1, 2014. In developing
the standardized HIS, we considered comments offered in response to the
CY 2013 HH PPS proposed rule (77 FR 41548 through 41573). In the FY
2014 Hospice Wage Index 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 6 NQF-endorsed
measures and 1 modified measure 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) (modified).
To achieve a comprehensive set of hospice quality measures
available for widespread use for quality improvement and informed
decision making, and to carry out our commitment to develop a quality
reporting program for hospices that uses standardized methods to
collect data needed to calculate quality measures, we finalized the HIS
effective July 1, 2014 (78 FR 48258). To meet the quality reporting
requirements for hospices for the FY 2016 payment determination and
each subsequent year, we require regular and ongoing
[[Page 52161]]
electronic submission of the HIS data for each patient admission to
hospice after July 1, 2014, regardless of payer or patient age (78 FR
48234 through 48258). We finalized a requirement in the FY 2014 Hospice
Wage Index final rule (78 FR 48258) that hospice providers collect data
on all patients to ensure that all patients regardless of payer or
patient age are receiving the same care and that provider metrics
measure performance across the spectrum of patients.
Hospices are required to complete and submit a HIS-Admission and a
HIS-Discharge record for each patient admission. Hospices failing to
report quality data via the HIS for patient admissions occurring in
2016 will have their market basket update reduced by 2 percentage
points in FY 2018 (beginning in October 1, 2017). In the FY 2015
Hospice Wage Index final rule (79 FR 50485 through 50487), we finalized
the proposal to codify the HIS submission requirement at Sec. 418.312.
The System of Record (SOR) Notice titled ``Hospice Item Set (HIS)
System,'' SOR number 09-70-0548, was published in the Federal Register
on April 8, 2014 (79 FR 19341).
Table 15--Previously Finalized Quality Measures Affecting the FY 2017 Payment Determination and Subsequent Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data submission
Quality measure NQF ID# Type Submission method deadlines
--------------------------------------------------------------------------------------------------------------------------------------------------------
Treatment Preferences................. 1641 Process Measure..................... Hospice Item Set.................... Within 30 days of
Beliefs/Values Addressed.............. 1647 patient admission or
discharge (Event Date).
Pain Screening........................ 1634
Pain Assessment....................... 1637
Dyspnea Screening..................... 1639
Dyspnea Treatment..................... 1638
Patients Treated with an Opioid who 1617
are Given a Bowel Regimen.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Comment: CMS received a comment regarding the retirement of the
seven day length of stay (LOS) exclusion for six of the care process
measures currently implemented in the HQRP. This commenter expressed
concern that in eliminating the LOS exclusion, provider behavior may
shift towards focusing on completing the HIS requirements and
compliance at the expense of addressing the needs and preferences of
imminently dying patients. Additionally, this commenter recommended
that CMS reconsider eliminating the LOS exclusion or risk adjust for
hospices with an excessive number of short-stay patients for patients.
Response: We appreciate the commenters' input on the retirement of
the LOS exclusion specification for six of the quality measures
currently implemented in the HQRP. Developing and adopting measures
that are meaningful and do not lead to negative unintended consequences
for patients or providers is important to us. At the time the measures
were developed, technical experts recommended that short patient stays
be excluded from those measures' denominators for assessing quality of
care in hospices. However, no national data regarding the implications
of the LOS exclusion was available to the Technical Expert Panel (TEP)
at that time. CMS's contractor analyzed data from the HIS to examine
the implications of the LOS exclusion on hospices' denominator size and
quality measure (QM) scores. Additionally, this analysis examined the
timing of when hospices perform the care processes assessed in the
quality measures. These analyses were conducted using HIS-Admission and
HIS-Discharge records for stays in July 1, 2014 through March 31, 2015.
The results of these analyses demonstrated that the denominator sizes
for the HQRP QMs are largely impacted by the current 7-day LOS
exclusion used to calculate the QMs. Excluding stays with LOS less than
7 days prevents some hospices from being included in QM score
calculations because they do not have any qualifying patient stays.
Therefore, removing the LOS exclusion criteria will increase the number
of patients included in the measures, and thus the number of hospices
that are included in the QM calculation. The impact of the LOS
exclusions on the distribution of hospices' scores is generally small
for all of the QMs. In addition, these analyses revealed that the care
processes targeted by the QMs are performed on the day of, or within
one day of, admission for the vast majority of patient stays. For
example, among patient admissions for which a pain screening was
administered, approximately 92 percent of screenings occurred on the
day of admission and close to 99 percent occurred within 1 day of
admission. This suggested that including stays of less than 7 days in
QM calculations (that is, removing the QM LOS exclusion) could be
appropriate and would not create a burden on hospices. In response to
these results, the individual QMs were submitted by the measures'
stewards to the NQF Palliative Care and End of Life Project for re-
endorsement in February 2016 and received preliminary approval. In sum,
6 of the 7 current HIS measures that were adopted in the FY 2014
Hospice Wage Index final rule excluded beneficiaries with a LOS of <7
days from the denominator. However, since these measures were adopted
in the HQRP, they have undergone their endorsement maintenance with the
NQF. As part of the maintenance endorsement, the LOS exclusion for the
6 HIS measures was proposed for removal. NQF has indicated initial
support for the removal of the LOS exclusion, and pending NQF
maintenance endorsement of the previously adopted measures, we
anticipate that the entire set of the 7 HIS measures will no longer
exclude any patients with LOS <7 days in future public reporting and
use in the HQRP. We appreciate the commenters' recommendation to risk
adjust these measures and will consider this recommendation for future
measure development efforts.
Comment: CMS received one comment requesting additional items or
response options on the HIS V1.00.0 to capture instances where data
regarding preferences or other care processes captured on the HIS are
not available for non-verbal patients admitted to hospice who do not
have a formal caregiver or responsible party available.
Response: We thank the commenter for their comment. For additional
information on how to respond to current HIS items when the patient is
nonverbal and/or a caregiver is unavailable, we refer readers to the
HIS Manual V1.02 available on the Hospice
[[Page 52162]]
Item Set portion of the CMS HQRP Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html. Specifically, we refer
readers to the HIS Manual Section F Item-Specific Tips, which specifies
roles of responsible parties for patients unable to self-report. The
HIS Manual states that the ``Responsible party'' refers to the legally
responsible or authorized individual, such as the Health Care Power of
Attorney or legal guardian. In the rare cases where there is no legal
guardian or power of attorney identified, the hospice should use state
law guidance to identify the appropriate surrogate decision-maker.
Other items that require patient or caregiver input, such as the pain
assessment items, can be completed for nonverbal patients using the
nonverbal assessment processes described in the HIS Manual.
5. Proposed Removal of Previously Adopted Measures
As mentioned in section III.C.3, a measure that is adopted and
implemented in the HQRP will be adopted for all subsequent years,
unless the measure is proposed for removal, suspension, or replacement
by CMS. Policies and criteria for removing a measure include those
mentioned in section III.C.3 of this proposed rule. CMS is not
proposing to remove any of the current HQRP measures at this time. Any
future proposals regarding removal, suspension, or replacement of
measures will be proposed in this section of future rules.
6. Proposed New Quality Measures for FY 2019 Payment Determinations and
Subsequent Years and Concepts Under Consideration for Future Years
a. Background and Considerations in Developing New Quality Measures for
the HQRP
As noted in section III.C.2 of this proposed rule, CMS's paramount
concern is to develop quality measures that promote care that is
person-centered, high quality, and safe. In identifying priority areas
for future measure enhancement and development, CMS takes into
consideration input from numerous stakeholders, including the MAP, the
MedPAC, Technical Expert Panels (TEP), and national priorities, such as
those established by the National Priorities Partnership, the HHS
Strategic Plan, the National Strategy for Quality Improvement in
Healthcare, and the CMS Quality Strategy. In addition, CMS takes into
consideration vital feedback and input from research published by our
payment reform contractor, as well as important observations and
recommendations contained in the Institute of Medicine (IOM) report,
titled ``Dying in America,'' released in September 2014.\6\ Finally,
the current HQRP measure set is also an important consideration for
future measure development areas; future measure development areas
should complement the current HQRP measure set, which includes HIS
measures and Consumer Assessment of Healthcare Providers and Systems
(CAHPS[supreg]) Hospice Survey measures.
---------------------------------------------------------------------------
\6\ IOM (Institute of Medicine). 2014. Dying in America:
Improving quality and honoring individual preferences near the end
of life. Washington, DC: The National Academies Press.
---------------------------------------------------------------------------
As stated in the FY 2016 Hospice Wage Index final rule (80 FR
47188), based on input from stakeholders, CMS identified several high
priority areas for future measure development, including: A patient
reported pain outcome measure; claims-based measures focused on care
practices patterns, including skilled visits in the last days of life;
responsiveness of the hospice to patient and family care needs; and
hospice team communication and care coordination. Of the aforementioned
measure areas, CMS has pursued measure development for two quality
measures: Hospice Visits when Death is Imminent Measure Pair, and
Hospice and Palliative Care Composite Process Measure-Comprehensive
Assessment at Admission. These measures were included in CMS' List of
Measures under Consideration (MUC) list for 2015 and discussed at the
MAP meeting on December 14 and 15, 2015. All materials related to the
MUC list and the MAP's recommendations for each measure can be found on
the National Quality Forum Web site, MAP Post-Acute Care/Long-Term Care
Workgroup Web page at: http://www.qualityforum.org/ProjectMaterials.aspx?projectID=75370. The MAP supported the direction
of each proposed measure.
Comment: Many comments were received about the HQRP quality
measures and concepts under consideration for future years. Overall,
commenters were supportive of CMS's efforts to develop a more robust
quality reporting program that includes development of two new quality
measures, the Hospice Visits when Death is Imminent Measure Pair, and
Hospice and Palliative Care Composite Process Measure-Comprehensive
Assessment at Admission. In addition to the two measures we proposed,
regarding measure development in future years, commenters urged CMS to
focus on meaningful quality measures and encouraged CMS to move towards
the development of outcome measures. Several commenters noted the
complexities associated with developing outcomes measures. These
commenters also recommended that CMS conduct regular measure testing
activities to ensure that all measures currently implemented in the
HQRP are relevant and meaningful to providers and consumers. Finally,
some commenters recommended the development of future measures of
hospice live discharge rates. Commenters believe that such measures
could contribute to quality information and hospice performance.
Response: We appreciate the commenters' input and recommendations
for future measure development areas for the HQRP. We plan to continue
developing the HQRP to respond to the measure gaps identified by the
MAP and others, and align measure development with the National Quality
Strategy and the CMS Quality Strategy. We will take these comments into
consideration in developing and implementing measures for future
inclusion in the HQRP. We would like to assure commenters that we are
pursuing opportunities related to the development of live-discharge
measures through environmental scans, public engagement, and
participation in special topic panels. We would also like to assure
commenters that for all measures implemented in the HQRP, we regularly
conduct measure testing activities according to the Blueprint for the
CMS Measures Management System Version 12.0 (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint-120.pdf). This ensures that measures continue to
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.
If measure testing activities reveal that a measure meets one of the
conditions for removal that is listed in the proposed rule (measure
performance among hospices high and unvarying, performance or
improvement in a measure does not result in better patient outcomes,
etc.), the measure will be considered for removal from the HQRP to
avoid unintended consequences and to ensure that providers' data
collection efforts are meaningful and are contributing to quality of
care. Finally, we would like to assure commenters that we continue to
explore opportunities to pursue
[[Page 52163]]
hospice outcome measures, and we appreciate the commenters' support for
such development efforts.
b. New Quality Measures for the FY 2019 Payment Determination and
Subsequent Years
We proposed two new quality measures for the HRQP 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.
(1) Proposed Quality Measure 1: Hospice Visits When Death Is Imminent
Measure Pair
Measure Background. This measure set addresses whether a hospice
patient and their caregivers' needs were addressed by the hospice staff
during the last days of life. This measure is specified as a set of 2
measures. Measure 1 assesses the percentage of patients receiving at
least 1 visit from registered nurses, physicians, nurse practitioners,
or physician assistants in the last 3 days of life. Measure 2 assesses
the percentage of patients receiving at least 2 visits from medical
social workers, chaplains or spiritual counselors, licensed practical
nurses, or hospice aides in the last 7 days of life. Measure 1
addresses case management and clinical care, while Measure 2 gives
providers the flexibility to provide individualized care that is in
line with the patient, family, and caregiver's preferences and goals
for care and contributing to the overall well-being of the individual
and others important in their life.
Measure Importance. The last week of life is typically the period
in the terminal illness trajectory with the highest symptom burden.
Particularly during the last few days before death, patients experience
myriad physical and emotional symptoms, necessitating close care and
attention from the integrated hospice team. Hospice responsiveness
during times of patient and caregiver need is an important aspect of
care for hospice consumers. In addition, clinician visits to patients
at the end of life have been demonstrated to be associated with
improved outcomes such as decreased risk of hospitalization, emergency
room visits, hospital deaths, decreased distress for caregivers, and
higher satisfaction with care.
Several organizations and panels have identified care of the
imminently dying patient as an important domain of palliative and
hospice care and established guidelines and recommendations related to
this high priority aspect of healthcare that affects a large number of
people. The NQF 2006 report A Framework for Preferred Practices for
Palliative Care Quality \7\ and the NCP Clinical Practice Guidelines
for Quality Palliative Care \8\ recommend that signs and symptoms of
impending death are recognized, communicated and educated, and care
appropriate for the phase of illness is provided. The American College
of Physicians Clinical Practice Guidelines \9\ recommend that
clinicians regularly assess pain, dyspnea, and depression for patients
with serious illness at the end of life. These measures address this
high priority area by assessing hospice staff visits to patients and
caregivers during the final days of life when patients and caregivers
typically experience higher symptom and caregiving burdens, and
therefore a higher need for care.
---------------------------------------------------------------------------
\7\ National Quality Forum. A National Framework and Preferred
Practices for Palliative and Hospice Care Quality. 2006; Available
from: http://www.qualityforum.org/publications/2006/12/A_National_Framework_and_Preferred_Practices_for_Palliative_and_Hospice_Care_Quality.aspx.
\8\ National Consensus Project, Clinical Practice Guidelines for
Quality Palliative Care. 3rd edition. 2013, National Consensus
Project: Pittsburgh, PA.
\9\ Qaseem, A., et al., Evidence-Based Interventions to Improve
the Palliative Care of Pain, Dyspnea, and Depression at the End of
Life: A Clinical Practice Guideline from the American College of
Physicians. Annals of Internal Medicine, 2008. 148(2): p. 141-146.
---------------------------------------------------------------------------
Measure Impact. The literature shows that health care providers'
practice is responsive to quality measuring and reporting.\10\ CMS
feels this research, while not specific to hospices, reasonably
predicts the effect of measures on hospice provider behavior.
Collecting information about hospice staff visits for measuring quality
of care, in addition to the requirement of reporting visits from some
disciplines on hospice claims, will encourage hospices to visit
patients and caregivers and provide services that will address their
care needs and improve quality of life during the patients' last days
of life.
---------------------------------------------------------------------------
\10\ Werner, R., E. Stuart, and D. Polsky, Public reporting
drove quality gains at nursing homes. Health Affairs, 2010. 29(9):
p. 1706-1713.
---------------------------------------------------------------------------
Performance Gap. The 2014 Abt Medicare Hospice Payment Reform
Report indicated that 28.9 percent of Routine Home Care hospice
patients did not receive a skilled visit on the last day of life.\11\
The Report defines a `skilled visit' as a visit from a nurse, social
worker, or therapist. This percentage could be, in part, a result of
rapid decline and unexpected death. The report revealed variation in
receipt of visits at the end of life related to multiple factors.
Patients who died on a weekday rather than a weekend, patients with a
very short length of stay (5 days or less), and patients aged 84 and
younger were more likely to receive a skilled visit in the last 2 days
of life. Smaller hospices and hospices in operation for 5 years or less
were slightly less likely to provide a visit at the end of life. States
with the lowest rates of no visits in the last days of life were some
of the more rural states (ND, WI, TN, KS, VT), whereas states with the
highest rates of no visits were more urban (NJ, MA, OR, WA, MN).
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\11\ Plotzke, M., et al., Medicare Hospice Payment Reform:
Analyses to Support Payment Reform. May 2014, Abt Associates Inc.
Prepared for Centers for Medicare and Medicaid Services: Cambridge,
MA.
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Existing Measures. This quality measure set will fill a gap by
addressing hospice care provided at the end of life. No current HQRP
measures address care beyond the hospice initial and comprehensive
assessment period, nor do any current HQRP measures relate to the
assessment of hospice staff visits to patients and caregivers in the
last week of life.
Stakeholder Support. A TEP convened by our measure development
contractor, RTI International, on May 7 and 8, 2015, provided input on
the measure concept. The TEP agreed that hospice visits when death is
imminent is an important concept to measure and supported data
collection using the HIS. A second TEP was convened October 19 and 21,
2015, to provide input on the technical specifications of this quality
measure pair. The TEP supported development of a measure set rather
than a single measure, using different timeframes to measure the
different types of care provided, and limiting the measures to patients
receiving routine home care. The NQF MAP met on December 14 and 15,
2015, and provided input to CMS. The MAP encouraged continued
development of the Hospice Visits when Death is Imminent Measure Pair
in the HQRP. More information about the MAP's recommendations for this
measure is available at http://www.qualityforum.org/ProjectMaterials.aspx?projectID=75370. While this measure is not
currently NQF endorsed, we recognize that the NQF endorsement process
is an important part of measure development and plan to submit this
measure pair for NQF endorsement.
Form, Manner, and Timing of Data Collection and Submission. Data
for this measure would be collected via the existing data collection
mechanism, the HIS. CMS has proposed that 4 new items be added to the
HIS-Discharge record to collect the necessary data elements for this
measure. CMS expects that data collection for this quality
[[Page 52164]]
measure via the 4 new HIS items would begin no earlier than April 1,
2017. Thus, under current CMS timelines, hospice providers would begin
data collection for this measure for patient admissions and discharges
occurring after April 1, 2017. Prior to the release of the new HIS data
items, CMS will provide education and training to hospice providers to
ensure all providers have adequate information and guidance to collect
and submit data on this measure to CMS.
Since the data collection mechanism is the HIS, providers would
collect and submit data using the same processes that are outlined in
sections III.C.7c through III.C.7e of this rule. In brief, processes in
section III.C.7c through III.C.7e specify that data for the measure
would be submitted to the Quality Improvement and Evaluation System
(QIES) Assessment Submission and Processing (ASAP) system, in
compliance with the timeliness criterion and threshold set out in
sections III.C.7c through III.C.7e.
For more information on the specifications and data elements for
the measure set, Hospice Visits when Death is Imminent, we refer
readers to the HQRP Specifications for the Hospice Item Set-based
Quality Measures document, available on the ``Current Measures''
portion of the CMS HQRP Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html. In addition, to facilitate the reporting of HIS
data as it relates to the implementation of the new measure, we
submitted a request for approval to OMB for the Hospice Item Set
version 2.00.0 under the Paperwork Reduction Act (PRA) process. The new
HIS data items that would collect this measure data are also available
for public viewing in the PRA package available at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
We received multiple comments pertaining to the Hospice Visits when
Death is Imminent Measure Pair. The following is a summary of the
comments we received on this topic and our responses:
Comment: We received many comments in support of our proposal to
implement the Hospice Visits when Death is Imminent Measure Pair.
Commenters emphasized the importance of visits at the end of life, and
stated that this measure pair would provide a valuable measure of
quality. Commenters also stated that they expect this measure will
improve quality of life during patients' final days and that this
measure could be useful to patients, families, and the Medicare
program. One commenter said that hospice nurses are often aware when
death is imminent because they are skilled at recognizing the final
stages of a terminal condition, and that most individuals and families
are aided and reassured by visits from some disciplines at the end of
life.
Response: We thank the commenters for their support of the Hospice
Visits when Death is Imminent Measure Pair in the HQRP. We agree that
visits at the end of life are an important component of hospice care
and that this measure can help to drive holistic, patient centered
quality improvement. We believe that this information will be useful to
consumers, providers, and payers.
Comment: Some commenters questioned whether the Hospice Visits when
Death is Imminent Measure Pair would foster better quality for hospice
care patients and requested evidence-based research showing the link
between hospice visits and quality. One commenter emphasized the
important role that hospices play in helping prepare patients and
caregivers for the end of life, and stated that if hospices provide
high quality preparation, then patients and families may need fewer
visits at the end of life. The commenter stated that a focus on visits
at the end of life may take focus away from empowering patients and
caregivers. One commenter stated that, as a process measure, this
measure pair does not adequately reflect high quality care, and urged
CMS to conduct further testing of the measure. One commenter cautioned
that, while sociodemographic differences in receipt of visits may
appear to indicate differences in quality, one must also take into
consideration possible differences in religious beliefs and cultural
values that may affect desire for visits. One commenter noted that
these measures alone might not be representative of the quality of care
that hospice beneficiaries and their families receive.
Response: We thank the commenters for their feedback. We are
committed to the ensuring that all quality measures implemented in the
HQRP meet the goals of the program, which include distinguishing
performance among hospices and contributing to better patient outcomes.
We believe that provision of hospice visits at the end of life is
an important component of high quality hospice care for most patients.
The last week of life is typically the period in the terminal illness
trajectory with the highest symptom burden and the literature supports
hospice visits when death is imminent as a high priority in end-of-life
care. Clinician visits to patients at the end of life have been
demonstrated to be associated with improved outcomes such as decreased
risk of hospitalization, emergency room visits, and hospital death; and
higher satisfaction with care.\12\ \13\ \14\ Measurements of visits at
the end of life are already used in the literature as quality
indicators for end of life or hospice care.\15\ \16\ \17\ Studies
focusing on the expectations of patients and families also demonstrate
the importance of care and attention from the hospice team in the days
leading up to death. Caregivers of dying patients agree overwhelmingly
with the importance of preparation at the end of life. Hospice
assistance, ranging from legal to logistical to emotional, is paramount
in preparing hospice patients and their families for imminent
death.\18\ Bereaved family members and friends from a variety of
settings identified the provision of physical comfort and emotional
support to dying patients and their families as fundamental aspects of
high-quality care.\19\
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\12\ Seow, H., Barbera, L., Howell, D., & Dy, S. M. (2010).
Using more end-of-life homecare services is associated with using
fewer acute care services: a population-based cohort study. Med
Care, 48(2), 118-124. doi:10.1097/MLR.0b013e3181c162ef.
\13\ Almaawiy, U., Pond, G. R., Sussman, J., Brazil, K., & Seow,
H. (2014). Are family physician visits and continuity of care
associated with acute care use at end-of-life? A population-based
cohort study of homecare cancer patients. Palliat Med, 28(2), 176-
183. doi:10.1177/0269216313493125.
\14\ Pivodic, L., Harding, R., Calanzani, N., McCrone, P., Hall,
S., Deliens, L. & Gomes, B. (2015). Home care by general
practitioners for cancer patients in the last 3 months of life: An
epidemiological study of quality and associated factors. Palliat
Med. doi:10.1177/0269216315589213.
\15\ Barbera, L., Seow, H., Sutradhar, R., Chu, A., Burge, F.,
Fassbender, K., . . . Potapov, A. (2015). Quality Indicators of End-
of-Life Care in Patients With Cancer: What Rate Is Right? J Oncol
Pract, 11(3), e279-287. doi:10.1200/jop.2015.004416.
\16\ Gandhi, S. O. (2012). Differences between non-profit and
for-profit hospices: patient selection and quality. Int J Health
Care Finance Econ, 12(2), 107-127. doi:10.1007/s10754-012-9109-y.
\17\ Lorenz, K. A., Ettner, S. L., Rosenfeld, K. E., Carlisle,
D. M., Leake, B., & Asch, S. M. (2002). Cash and compassion: profit
status and the delivery of hospice services. J Palliat Med, 5(4),
507-514. doi:10.1089/109662102760269742.
\18\ Steinhauser, K. E., Christakis, N. A., Clipp, E. C.,
McNeilly, M., McIntyre, L., & Tulsky, J. A. (2000). Factors
considered important at the end of life by patients, family,
physicians, and other care providers. Jama, 284(19), 2476-2482.
\19\ Steinhauser, K. E., Christakis, N. A., Clipp, E. C.,
McNeilly, M., McIntyre, L., & Tulsky, J. A. (2000). Factors
considered important at the end of life by patients, family,
physicians, and other care providers. Jama, 284(19), 2476-2482.
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The literature shows that health care providers' practices are
responsive to
[[Page 52165]]
quality measurement and reporting.\20\ We believe that this research,
while not specific to hospices, reasonably predicts the effect of
measures on hospice provider behavior. Collecting information about
hospice staff visits for measuring quality of care, in addition to the
requirement of reporting visits from some disciplines on hospice
claims, will encourage hospices to visit patients and caregivers and
provide services that will address their care needs and improve quality
of life during the patients' last days of life. While we agree that a
greater number of visits does not always indicate higher quality care,
based on the published literature and expert input, we believe that
most patients benefit from some visits near the end of life. For this
reason, this measure set is specified to measure receipt of at least 1
clinician visit (Measure 1) and at least 2 visits from other staff
(Measure 2), rather than measuring the total number of visits. A TEP
held in October 19 and 21, 2015, by our contractor agreed that a
measure of patients receiving at least a minimum number of visits would
be a better indicator of quality than a measure of the total number of
visits provided.
---------------------------------------------------------------------------
\20\ Werner, R., E. Stuart, and D. Polsky, Public reporting
drove quality gains at nursing homes. Health Affairs, 2010. 29(9):
p. 1706-1713.
---------------------------------------------------------------------------
We agree with the commenter that this measure pair alone may not
provide a full representation of the quality of care that hospices
provide. The previously finalized measures in the HQRP address care
processes at admission, and the Hospice CAHPS survey examines caregiver
experience retrospectively. This measure pair fills an important gap in
the HQRP by providing a measure of quality of care provided near the
time of death, and it is intended to be interpreted along with the
other measures in the HQRP to reflect quality of care provided by
hospices across several domains of care that are important to patients
and other stakeholders. CMS also plans to analyze the relationship
between this quality measure pair and other quality measures to support
the validity of this measure pair (that is, the measure reflects true
quality of care).
Comment: One commenter expressed concern that the results of the
Hospice Visits when Death is Imminent Measure Pair may be
mischaracterized once they are publicly reported, if appropriate
disclaimers are absent from the information provided. Another commenter
requested that CMS remind measure users that patients/families have the
right to decline services and that those declinations should not be
considered an ``under-service'' by the hospice provider.
Response: We thank the commenters for their feedback regarding
interpreting these measures. We agree that it is important to educate
both providers and consumers on how to use and interpret these quality
measures. Prior to public reporting of this measure, we will provide
resources through the Hospice Compare Web site to aid consumers in
interpreting the quality metrics reported there. CMS has carefully
considered usability by consumers throughout the measure development
process. The measure specifications take into account usability
feedback from a TEP, caregiver workgroup, and clinical user panel. We
recognize that some patients may decline services and that rapid and
unanticipated patient declines do occur; thus, a score of 100% is not
the expectation for this measure pair.
Comment: Some commenters stated that it is not always known when a
patient's death is imminent. One commenter stated that there is not
always an opportunity for hospices to provide the visits specified in
this measure set if a patient experiences a rapid and unanticipated
decline.
Response: We understand that it is not always possible to
accurately predict time of death. However, the last week of life is
typically the period in the terminal illness trajectory with the
highest symptom burden, especially during the last few days before
death. We recognize that rapid and unanticipated patient declines do
occur; thus, a score of 100 percent is not the expectation for this
measure pair. We do expect that hospices delivering high quality care
will be responsive to the patient and caregiver needs that arise during
the last days of a patient's life. In order to address performance gaps
in this measure, providers may be motivated to proactively assess
symptom burden, resulting in improved symptom management and higher
quality of life during the final days.
Comment: We received some comments related to the structure of the
Hospice Visits when Death is Imminent Measure Pair and intent of each
measure. Some comments indicated that commenters might have
misinterpreted the intent of this measure pair. For example, one
commenter stated that adoption of this measure pair would in fact
create three visit metrics, and another commenter referenced the
calculation of a composite measure for visits at the end of life. Some
commenters interpreted the specifications as not including visits
addressing spiritual or psychosocial suffering in the 3 days before
death.
Some commenters requested clarification of the calculation of each
of these measures and of the disciplines included in each. One
commenter recommended that Measure 1 and Measure 2 be combined into one
measure in order to streamline data collection. One commenter requested
that RN visits be included in both Measure 1 and Measure 2 since some
interventions to manage symptoms may only be provided by an RN.
Response: We wish to clarify the intent of this measure pair. The
Hospice Visits when Death is Imminent Measure Pair will be calculated
and reported as two separate measures. These measures are intended to
be interpreted as a set. For more information on the specifications and
data elements for the measure set, Hospice Visits when Death is
Imminent Measure Pair, we refer readers to the HQRP Specifications for
the Hospice Item Set-based Quality Measures document, available on the
``Current Measures'' portion of the CMS HQRP Web site: https://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/HospiceQuality-Reporting/CurrentMeasures.html.
The two measures are intended to capture distinct aspects of
hospice care at the end of life. The inclusion of registered nurses,
physicians, nurse practitioners, and physician assistants in Measure 1
is intended to capture the range of clinical disciplines that might
visit a patient, depending on patient and hospice preferences, and uses
a 3-day timeframe to reflect the active dying phase. The inclusion of
medical social workers, chaplains or spiritual counselors, licensed
practical nurses, and hospice aides in Measure 2 is intended to allow
for flexible and individualized care in line with patient, family, and
caregiver preferences. The 7-day time frame covers both the active
dying phase and the transition period before, and thus could also
capture important visits related to preparation for active dying. To
clarify, the 7-day time frame is inclusive of the 3 days prior to
death. Data collection is conducted at the discipline level in order to
provide us with sufficient information to conduct reliability and
validity testing and possible future measure refinement.
Comment: We received some comments regarding the types of visits
included in the Hospice Visits when Death is Imminent Measure Pair.
Some commenters requested that all visits on the date of death be
included in the measures, including postmortem visits, as this is an
important service that hospices provide. One commenter
[[Page 52166]]
recommended that a new, separate measure could look at postmortem
visits. Some commenters requested that phone calls or videoconferencing
be included in the measures. One commenter stated that phone calls may
be an especially important form of contact in rural areas. A few
commenters requested clarification of the definition of a visit counted
for quality purposes, and one inquired what visit duration is expected.
Response: We thank the commenters for their feedback regarding the
types of visits included in this measure pair. We agree that post
mortem and bereavement visits are an important service for hospices to
provide. However, we believe that these services are outside the scope
of this quality measure pair, which focusses specifically on visits
when death is imminent. These visits provided shortly prior to death
are intended to address the increased symptom burden many patients
experience when death is imminent and provide an opportunity for
proactive assessment and communication.
We recognize that some providers use phone calls to supplement care
provided in person and that these calls can be helpful in facilitating
ongoing care and communication. However, in agreement with a TEP and
based on the available evidence, we consider these calls as a
supplement to, and not a replacement for, in-person care, particularly
when death is imminent. For this reason, phone calls are not included
in the definition of a visit for this measure pair. Prior to
implementation of the HIS V2.00.0, we will provide hospices with
guidance and training materials, including an updated version of the
HIS Manual. These training materials will further clarify the types of
visits included in this measure pair and other item coding information.
Comment: We received many comments regarding the disciplines
included in each of the Hospice Visits when Death is Imminent measures.
One commenter stated that this measure pair recognizes the value of the
core interdisciplinary team members and maintains a holistic approach
to care. Many commenters supported the inclusion of chaplains or
spiritual counselors and aides in Measure 2, as they play an important
role in the interdisciplinary team. Some commenters encouraged CMS to
conduct further research on the types of visits provided at the end of
life and present a clear rationale for inclusion or exclusion from this
measure. One commenter recommended that both measures be amended to
include any member of the hospice's interdisciplinary team.
Many commenters requested that visits from volunteers be included
in Measure 2. The commenters pointed out that the use of volunteers is
a Medicare requirement for hospices, and that volunteers play an
important role in the delivery of hospice care. One commenter indicated
that it might be burdensome to report data on volunteer visits, but
that inclusion of volunteers would be valuable. A couple of commenters
requested that visits from music therapists or massage therapists be
included in Measure 2.
Several commenters noted that although physician assistant (PA)
visits are included in this quality measure pair, this discipline is
not identified by CMS as a core or non-core service of a hospice
provider. Some of these commenters requested that PA visits be removed
from the measure in order to align with the Conditions of Participation
and Medicare payment practices. Some of these commenters supported the
inclusion of PAs and recommended that their role be clarified. One
commenter stated that since the use of PAs is limited, inclusion of PA
visits would negatively skew the data.
One commenter noted that a Licensed Practicing Nurse's (LPN) scope
of practice varies from state to state, and asked that CMS consider
removing LPN visits from the measure to make the measure more uniform
nation-wide. One commenter expressed appreciation for the inclusion of
LPNs and stated that the discipline is frequently used.
Some commenters requested that bereavement coordinator or
bereavement counselor visits be included in this measure pair. One
commenter requested clarification of whether a visit from a provider
contracted but not employed by a hospice program would be considered a
visit under this measure pair.
Response: We thank the commenters for their support of the
disciplines included in this measure, including chaplains or spiritual
counselors and aides. This measure pair is designed to allow hospices
flexibility to determine the most appropriate discipline or disciplines
to visit a patient. The inclusion of registered nurses, physicians,
nurse practitioners, and physician assistants in Measure 1 is intended
to capture the range of clinical disciplines that might visit a
patient, depending on patient and family preferences and emerging care
needs in the last days of life. Similarly, the inclusion of medical
social workers, chaplains or spiritual counselors, licensed practical
nurses, and hospice aides in Measure 2 is intended to allow for
flexible and individualized care in line with patient, family, and
caregiver preferences. This measure is not intended to require visits
from any given discipline, but aims to allow flexibility in the types
of visits provided. The Hospice Conditions of Participation state that
the interdisciplinary group must include, but is not limited to, a
doctor of medicine or osteopathy, a registered nurse, a social worker,
and a pastoral or other counselor. Visits from all of these disciplines
are included in this measure pair, as well as from some additional
disciplines. We have carefully researched the topic of which
disciplines to include in this measure pair, including an environmental
scan, pilot test of this measure in summer 2015, TEP discussions on May
7 and 8, 2015, and October 19 and 21, 2015, and input from our Clinical
Users Panel and Caregiver Workgroup.
Regarding volunteer visits, we agree that volunteers play an
important role in high quality hospice care and that their visits are
important to patients and families. Visits from volunteers were
included in an early version of this measure, which pilot tested for
feasibility in summer 2015. Many of the hospices included in the pilot
had trouble reporting data on visits from volunteers because the
records of volunteer visits were often stored in a separate system and
were frequently delayed. The data was unreliable, and hospices reported
significant reporting burden. This topic was discussed with the TEP,
held October 19 and 21, 2015. After reviewing the results from the
pilot test and thoroughly discussing the issues, the TEP members did
not support including visits from volunteers in this measure pair. For
the same reasons, the TEP advised against including complementary and
alternative therapists such as music or massage therapists in this
measure pair, though they do provide important services.
Regarding physician assistant visits, although Medicare does not
provide separate payments for visits from physician assistants, these
services would be covered under the hospice per diem. Additionally,
this measure is an all-payer measure and some states and other programs
may authorize physician assistants to provide hospice care under
separate payments. This measure pair is separate from payment and
should focus on services provided by hospices and not be restricted by
the terms of payment by Medicare. Therefore, the inclusion of physician
assistants in the
[[Page 52167]]
measure specifications provides the flexibility for hospices that may
have physician assistants to count these clinical visits as part of
Measure 1. We wish to clarify that the absence of physician assistant
visits will not negatively skew the data reported in this measure.
Visits from physician assistants are one of the options included in
Measure 1, but patients will also be included in the numerator of the
measure if they receive a visit from a registered nurse, physician, or
nurse practitioner.
We thank the commenters for their feedback regarding the inclusion
of LPNs in Measure 2. Members of our TEP agreed that LPNs provide an
important service in hospice care that is distinct from the role of
RNs. For this reason, we have included visits from LPNs in Measure 2 of
this measure pair.
We appreciate the commenters' recommendations to include
bereavement coordinators, and agree that visits from these disciplines
are important for many patients and families. However, we believe that
bereavement services are outside the scope of this quality measure
pair, which focusses specifically on visits, which may address the
increased symptom burden many patients experience when death is
imminent, and provide an opportunity for proactive assessment and
communication.
Regarding contracted hospice staff, we clarify that visits from
contracted staff may be included in this measure pair. As defined in
the HIS Manual V1.02, hospice staff members may include volunteers,
contractors, and affiliates.
Comment: Some commenters recommended changes to the Hospice Visits
when Death is Imminent Measure Pair to further align the two measures.
A few commenters suggested that both Measure 1 and Measure 2 be
measured over a 7-day timeframe in order to improve consistency between
the measures and simplify data collection for providers. A few
commenters recommended that CMS consider altering Measure 2 such that
it includes in the numerator patients who receive one visit from
medical social workers, chaplains or spiritual counselors, licensed
practical nurses or hospice aides in the final seven days of life.
Response: We thank the commenters for their feedback on the
specifications of the two measures in this measure pair. As currently
specified, Measure 1 uses a 3-day timeframe and Measure 2 uses a 7-day
timeframe. A TEP meeting held October 19 and 21, 2015, provided input
on the timeframes. The TEP indicated that the 3-day timeframe would be
reflective of the active dying phase, and that it would be appropriate
to measure clinical visits provided during the active dying phase. The
7-day time frame covers both the active dying phase and the transition
period before, and thus could also capture important visits related to
preparation for active dying. An analysis of Medicare claims indicates
that most routine home care patients (94 percent) receive at least one
skilled visit from a nurse, social worker, therapist or physician in
the last four days of life.\21\ Because of this, there may be a ceiling
effect for these quality measures using a longer time frame.
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\21\ Plotzke, M. C., T.J.; Axelrod, Elizabeth; Hunt, Meaghan;
Muma, Allison; Gozalo, Pedro; Teno, Joan. (2015). Medicare Hospice
Payment Reform: Analysis of How the Medicare Hospice Benefit is
Used. Retrieved from https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/December-2015-Technical-Report.pdf.
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The current specification of Measure 2 limits the numerator to
patients who receive at least two visits from those disciplines in the
final 7 days of life. Using two visits rather than one may also serve
to reduce the expected ceiling effect that is likely to result from
grouping multiple disciplines together in Measure 2.
Comment: Many commenters pointed out that, in keeping with the
individualized and patient-centered focus of hospice care, patients and
families have the option of declining visits from hospice providers if
they deem them unnecessary or unwanted. Commenters indicated that
patients and caregivers might decline a visit for various reasons:
Desire for privacy at the end of life, adequate preparation for the end
of life such that additional visits are not necessary, or patient is
receiving receipt of similar services from outside of the hospice
provider. Some commenters recommended that revisions be made to the HIS
Discharge form to allow a hospice to indicate that a patient or family
was offered a visit included in either Measure 1 or Measure 2, but
refused or deferred the visit. Some commenters recommended that
patients who refuse an offered visit be included in the measure
numerator, while others recommended that these patients be excluded
from the measure pair, and a few recommended that the measures be risk
adjusted to reflect patient refusal of services.
Some commenters cautioned that this measure pair could result in an
unintended consequence: Hospices might provide unnecessary or unwanted
visits, thus undermining patient and family preferences and choice. One
commenter cautioned that specifying when particular staff must visit
would undermine the flexibility hospices have in customizing the plan
of care. Some commenters pointed out that, by respecting the wishes of
some patients to receive fewer visits, a hospice might have lower
scores on this measure pair but that it would not reflect an issue with
quality of care.
Response: We thank the commenter for their feedback about patients
and families that may refuse a visit at the end of life. In a pilot
study conducted by our measure development contractor, hospices
reported that information on visit refusal is available, but is
burdensome for hospices to report. In addition, fewer than 4 percent of
patients in the pilot study refused a visit from a given discipline,
and no patients refused all visits offered. By including multiple
disciplines in each measure, the Hospice Visits when Death is Imminent
Measure Pair is designed to allow hospices flexibility to determine the
most appropriate discipline or disciplines to visit a patient, and to
consider patient and family preferences. A TEP held by our measure
development contractor did not expect that there would be wide
variation in the rate of visit refusal across hospices. The TEP
determined that the burden of data collection would outweigh the
benefit of excluding patients who refuse visits. For these reasons, we
determined not to require hospices to report data on visit refusals.
Hospices may wish to track visit refusals internally for quality
improvement purposes. This measure pair will be tested for reliability
and validity prior to public reporting. We recognize that some patients
may decline services and that rapid and unanticipated patient declines
do occur; thus, the expectation is not for hospices to score 100
percent on this measure pair. We will take these comments into account
during future measure development.
Comment: Some commenters recommended using risk adjustment or
exclusions to account for patient characteristics in the Hospice Visits
when Death is Imminent Measure Pair. Some commenters stated that
patients with shorter lengths of stay will likely receive different
visits than patients with longer lengths of stay. Commenters requested
that CMS examine any differences, and some requested that the Hospice
Visits when Death is Imminent Measure Pair be risk adjusted or
stratified for length of stay in hospice. Another commenter requested
that case mix adjustment be used in the calculation of this measure
pair.
[[Page 52168]]
One commenter recommended that patients with a length of stay
shorter than 5 days be excluded from Measure 2. This is the length of
time allowed by Hospice Conditions of Participation requirements for
the comprehensive assessments to be completed, and the commenter
expects that some patients might not receive two visits from a medical
social worker, chaplain or spiritual counselor, licensed practical
nurse, or hospice aide before Day 5. Another commenter recommended that
patients with a length of stay of three days or fewer be excluded from
Measure 1 if the only visit received is the initial nursing assessment.
The commenter expressed concern that for such short lengths of stay,
the measure would function as an indicator of compliance rather than of
quality.
Finally, one commenter requested clarification of whether this
measure pair would be applied across all levels of care.
Response: We thank the commenters for their feedback. As currently
specified, this measure set is not risk adjusted. A TEP convened by our
measure development contractor discussed possible risk adjustment of
this measure pair, including risk adjustment by diagnosis or length of
stay. The TEP determined that diagnosis may not reliably predict
symptom burden at the end of life and therefore may not reliably
predict need for visits. The TEP members determined that it might be
important to take length of stay into account in measure calculations.
We will continue to consider this feedback, and will examine measure
performance, including the potential need for risk adjustment in the
future.
As currently specified, Measure 1 does not include a length of stay
exclusion, while Measure 2 excludes patients with a length of stay less
than or equal to one day (that is, admitted and discharged on the same
day). The rationale for excluding patients with a very short length of
stay from Measure 2 is that Measure 2 requires two visits from select
hospice staff, and it may be difficult or possibly inappropriate to
provide more than one such visit for patients receiving only one day of
hospice care. We do not exclude these patients from Measure 1 because
Measure 1 specifies at least one clinician visit, and it is reasonable
to expect that a hospice would provide at least one such visit, even
for patients with a very short length of stay. It is acceptable if this
visit is the initial nursing assessment visit. One of the goals of this
measure pair is to increase prospective assessment of patient needs and
timely management of symptoms prior to death, and this can be
accomplished during the initial nursing assessment visit as well as
other types of visits provided in the final days to patients with
longer length of stay. We do not intend to increase burden on providers
or patients by requiring specific types of visits to meet the goals of
this measure. Patients with short lengths of stay are expected to have
high symptom burden throughout their short stay and can benefit from
hospice visits. For these reasons, patients with short lengths of stay
are included in this measure.
This measure pair currently includes only patients who received
routine home care. It does not include patients who received general
inpatient care, respite care, or continuous home care during the
measure timeframes. Routine home care patients for whom the hospice
receives a service intensity add-on payment are included in this
measure, as this payment is an add-on to the routine home care rate.
Comment: Some commenters encouraged CMS to obtain NQF endorsement
prior to proposing new measures. One commenter expressed appreciation
that this measure development process has included input from the
Measure Applications Partnership (MAP).
Response: We appreciate the commenters' input and support of the
NQF endorsement process. Our paramount concern is the successful
development of a HQRP that promotes the delivery of high quality
healthcare services. We seek to adopt measures for the HQRP that
promote patient-centered and high quality care. Our measure selection
activities for the HQRP take into consideration input from the MAP,
convened by the NQF, as part of the established CMS pre-rulemaking
process required under section 1890A of the Act. The NQF MAP met on
December 14th and 15th, 2015 and encouraged continued development of
this measure pair. Additionally, while this measure is not currently
NQF-endorsed, we recognize that the NQF endorsement process is an
important part of measure development and plan to submit this measure
for NQF endorsement. This quality measure will fill a gap by addressing
quality of hospice care at the end of life. Furthermore, no current
NQF-endorsed measures address hospice care when death is imminent, and
this measure is a first step towards that goal. CMS is establishing the
timeline for seeking NQF endorsement for this quality measure and will
communicate this timeline to the public in future rulemaking cycles.
Comment: One commenter asked whether CMS would correlate the
Hospice Visits when Death is Imminent Measure Pair with the Hospice
CAHPS results. Another commenter recommended that CMS compare outcomes
as measured by the HIS care processes and the CAHPS survey with the
data collected on visits at the end of life to guide refinement of this
measure pair.
Response: We plan to conduct reliability and validity testing of
this measure pair as part of ongoing measure maintenance and refinement
and to prepare for NQF endorsement. As part of those efforts, we will
examine the correlations of the paired measures with other quality
measures calculated from the HIS and possibly from the CAHPS.
Comment: Some commenters indicated that data collection for the
Hospice Visits when Death is Imminent Measure Pair would be burdensome
for providers, and potentially duplicative of the information about
visits reported in Medicare claims. One commenter requested that claims
data be used to calculate this measure pair in order to reduce provider
burden of data collection. Another commenter encouraged CMS to
establish a claims code for spiritual counselor/chaplain visits so that
their visits can be reviewed for reimbursement and quality
considerations. One commenter indicated that this measure pair would be
calculated using claims data.
Response: We wish to clarify the data source for this measure pair.
This measure will be calculated using data from the HIS V2.00.0, and
will not be a claims-based measure. This HIS-based measure pair will
expand upon information that would be available in Medicare hospice
claims. The HIS includes data for all hospice patients, regardless of
payment source, while claims data capture only Medicare Fee-for-service
beneficiaries. Therefore, the use of assessment data allows the measure
to be inclusive of all patients regardless of payer. Medicare claims
capture visits from certain disciplines, including skilled nursing,
medical social services, aides, physical therapy, occupational therapy,
and speech therapy--language pathology. HIS items will capture hospice
visits by members of additional disciplines that are not included in
the Medicare hospice claims (for example, chaplains). Finally, visit
information on the HIS can be assessed and reported in a timelier
manner than Medicare claims, providing hospices with opportunities to
review and improve care.
Comment: Some commenters requested that sufficient time be given
[[Page 52169]]
prior to measure implementation of the Hospice Visits when Death is
Imminent Measure Pair to ensure time for software vendors to develop
new processes, and hospices to upgrade their EMR systems, train staff,
and conduct testing. One commenter recommended that CMS delay
initiation of data collection for this measure pair until October 1,
2016. One commenter encouraged CMS to solicit feedback from the hospice
industry and software vendors to determine whether necessary updates
can be made by April 1, 2017. Other commenters recommended a period of
data collection on the proposed measures prior to implementation of the
measures.
Response: We appreciate the commenters' feedback regarding the
timeline for implementation and public reporting of this measure pair.
We would like to clarify the implementation date proposed in this rule;
data used for calculation of this measure pair will be collected via
the HIS V2.00.0. The HIS V2.00.0 is undergoing review as part of a PRA
package under OMB number 0938-1153 and will be implemented April 1,
2017. This measure pair is proposed for the FY 2019 payment
determination and subsequent years. The HIS V2.00.0 is currently
available for review by software vendors and hospice providers. Some of
the activities that are necessary prior to implementation can be done
concurrently. For example, hospice education and training in the new
items and data abstraction can be conducted at the same time as vendor
development of software. As stated in section III.C.7.c, providers may
also use the Hospice Abstraction Reporting Tool (HART) software, which
is free to download and use. HART provides an alternative option for
hospice providers to collect and maintain facility, patient, and HIS
Record information for subsequent submission to the QIES ASAP system.
We agree it is critical to establish the reliability and validity of
the quality measures prior to public reporting. We plan to conduct data
analysis to demonstrate the ability of the quality measures to
distinguish the quality of services provided. More detail on public
display is provided in section III.C.11 of this rule.
Comment: Some commenters drew connections between the Hospice
Visits when Death is Imminent Measure Pair and the Service Intensity
Add-on payment. Some commenters recommended delaying implementation of
this measure pair until the impact of the SIA payment is better
understood. One commenter recommended that CMS use the data obtained
for Measure 2 to update the payment of the SIA payment to include
visits by licensed practical nurses and other disciplines. One
commenter stated that CMS should align financial payment and quality
measures.
Response: We thank the commenters for their feedback regarding the
Hospice Visits when Death is Imminent Measure Pair and the SIA. CMS
adopted SIA payments to address the observed misalignment between
resource use and associated Medicare payments and to improve patient
care through the promotion of skilled visits at end of life with
minimal claims processing systems changes. While it may be good for
payment and quality to align when possible, this measure pair is a
measure of quality, not of practice driven by reimbursement structure.
We will take into consideration using measure data for further
refinement of the SIA.
Final Action: After consideration of the comments, we are
finalizing our proposal to implement the Hospice Visits when Death is
Imminent Measure Pair effective April 1, 2017. Data will be collected
starting on such date, and will, if not reported, affect payments for
FY 2019.
(2) Proposed Quality Measure 2: Hospice and Palliative Care Composite
Process Measure--Comprehensive Assessment at Admission
Measure Background. The Hospice and Palliative Care Composite
Process Measure--Comprehensive Assessment at Admission is a composite
measure that assesses whether a comprehensive patient assessment is
completed at hospice admission by evaluating the number of individual
care processes completed upon admission for each hospice patient stay.
A composite measure, as defined by the NQF, is a combination of two or
more component measures, each of which individually reflects quality of
care, fashioned into a single performance measure with a single
score.\22\ For more information on composite measure definitions,
guiding principles, and measure evaluation criteria, we refer readers
to the NQF Composite Performance Measure Evaluation Guidance
Publication available at https://www.qualityforum.org/Publications/2013/04/Composite_Performance_Measure_Evaluation_Guidance.aspx. A total
of 7 individual care processes will be captured in this composite
measure, which include the 6 NQF-endorsed quality measures and 1
modified NQF-endorsed quality measure currently implemented in the
HQRP. Thus, the Hospice and Palliative Care Composite Process quality
measure will use the current HQRP quality measures as its components.
These individual component measures address care processes around
hospice admission that are clinically recommended or required in the
hospice CoPs.\23\ This measure calculates the percentage of patients
who received all care processes at admission. To calculate this
measure, the individual components of the composite measure are
assessed separately for each patient and then aggregated into one score
for each hospice.
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\22\ National Quality Forum. (2013). Composite Performance
Measure Evaluation Guidance: National Quality Forum.
\23\ Medicare and Medicaid Programs: Hospice Conditions of
Participation, Part 418 subpart 54. Centers for Medicare and
Medicaid Services, June 5, 2008.
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Measure Importance. This composite quality measure for
comprehensive assessment at admission addresses high priority aspects
of quality hospice care as identified by both leading hospice
stakeholders and beneficiaries receiving hospice services. The NCP for
Quality Palliative Care Clinical Practice Guidelines for Quality
Palliative Care established 8 core palliative care domains, and this
composite measure captures 4 of those domains.\24\ The 4 domains
captured by this composite measure are the Structure and Process of
Care Domain; the Physical Aspects of Care Domain; the Spiritual,
Religious, and Existential Aspects of Care Domain, and the Ethical and
Legal Aspects of Care Domain. The NCP guidelines placed equal weight on
both the physical and psychosocial domains, emphasizing a comprehensive
approach to patient care. For more information on the NCP domains for
palliative care, refer to http://www.nationalconsensusproject.org/guidelines_download2.aspx. In addition, the Medicare Hospice CoPs
require that hospice comprehensive assessments identify patients'
physical, psychosocial, emotional, and spiritual needs and address them
to promote the hospice patient's comfort throughout the end-of-life
process. Furthermore, the person-centered, family, and caregiver
perspective align with the domains identified by the CoPs and NCP, as
patients and their families/caregivers also place value on physical
symptom management and spiritual/psychosocial care as important factors
at the end of
[[Page 52170]]
life.25 26 A composite measure serves to ensure all hospice
patients receive a comprehensive assessment for both physical and
psychosocial needs at admission.
---------------------------------------------------------------------------
\24\ The National Consensus Project for Quality Palliative Care
Clinical Practice Guidelines for Quality Palliative Care 3rd edition
2013.
\25\ Singer PA, Martin DK, Kelner M. Quality End-of-Life Care:
Patients' Perspectives. JAMA. 1999;281(2):163-168. doi:10.1001/
jama.281.2.163.
\26\ Steinhauser KE, Christakis NA, Clipp EC, McNeilly M,
McIntyre L, Tulsky JA. Factors Considered Important at the End of
Life by Patients, Family, Physicians, and Other Care Providers.
JAMA. 2000;284(19):2476-2482. doi:10.1001/jama.284.19.2476.
---------------------------------------------------------------------------
Measure Impact. The literature indicates that health care
providers' practice is responsive to quality measures reported.\27\ CMS
feels this research, while not specific to hospices, reasonably
predicts the effect of measures on hospice provider behavior.
Collecting information about the total number of care processes
conducted for each patient will incentivize hospices to conduct all
desirable care processes for each patient and provide services that
will address their care needs and improve quality during the time he or
she is receiving hospice care. Additionally, creating a composite
quality measure for comprehensive assessment at admission will provide
consumers and providers with a single measure regarding the overall
quality and completeness of assessment of patient needs at hospice
admission, which can then be used to meaningfully and easily compare
quality across hospice providers and increase transparency.
---------------------------------------------------------------------------
\27\ Werner, R., E. Stuart, and D. Polsky, Public reporting
drove quality gains at nursing homes. Health Affairs, 2010. 29(9):
p. 1706-1713.
---------------------------------------------------------------------------
Performance Gap. Analyses conducted by our measure development
contractor, RTI International, show that hospice performance scores on
the current 7 HQRP measures are high (a score of 90 percent or higher
on most measures); however, these analyses also revealed that, on
average, a much lower percentage of patient stays in a hospice had
documentation that all of these desirable care processes were completed
at admission. Thus, by assessing hospices' performance of comprehensive
assessment, the composite measure sets a higher standard of care for
hospices and reveals a larger performance gap. A similar effect has
been shown in the literature where facilities are achieving more than
90 percent compliance with individual measures, but compliance numbers
decrease when multiple measures are combined as one.28 29
The performance gap identified by the composite measure creates
opportunities for quality improvement and may motivate providers to
conduct a greater number of high priority care processes for as many
patients as possible upon admission to hospice.
---------------------------------------------------------------------------
\28\ Nolan, T., & Berwick, D. M. (2006). All-or-none measurement
raises the bar on performance. JAMA [H.W. Wilson--GS], 295(10),
1168.
\29\ Agency for Healthcare Research and Quality. (2004).
National Healthcare Quality Report.
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Existing Measures. The Family Evaluation of Hospice Care (FEHC),
NQF #0208, is a precursor of the Hospice CAHPS[supreg]. The surveys
cover some similar domains. However, a major difference between them is
the detailed requirements for survey administration of the
CAHPS[supreg] Hospice Survey, which allow for comparison of hospice
programs, The Hospice CAHPS[supreg] survey quality measure is not yet
endorsed by NQF. CMS has recently submitted the CAHPS[supreg] Hospice
Survey (experience of care) measure (NQF #2651) to be considered for
endorsement under the Palliative and End-of-Life Care Project 2015-
2016. For more information regarding this project and the measure
submitted, we refer readers to https://www.qualityforum.org/ProjectMeasures.aspx?projectID=80663. In addition, we refer readers to
section III.C.9 of this rule for more information on the Hospice
CAHPS[supreg] survey and associated quality measures. The
CAHPS[supreg]-based quality measures submitted to NQF include patient
and caregiver experience of care outcome measures and CMS plans to
propose these measures as part of the HQRP measure set in future
rulemaking cycles. A key difference between the FEHC, Hospice
CAHPS[supreg] and the Hospice and Palliative Care Composite Process
Measure is that the FEHC and Hospice CAHPS[supreg] focus on the
consumer's perspective of their health agency and experience, whereas
the Hospice and Palliative Care Composite Process Measure focuses on
the clinical care processes that are actually delivered by the hospice
to each patient.
Stakeholder Support. A TEP convened by our measure development
contractor, RTI International, on December 2, 2015, provided input on
this measure concept. The TEP unanimously agreed that a comprehensive
hospice composite measure is an important measure and supported data
collection using the HIS. The NQF MAP met on December 14th and 15th,
2015 and provided input to CMS. In their final recommendation, the MAP
encouraged continued development of the Hospice and Palliative Care
Composite Process Measure--Comprehensive Assessment at Admission
measure. More information about the MAP's recommendations for this
measure is available at http://www.qualityforum.org/ProjectMaterials.aspx?projectID=75370.
While this measure is not currently NQF-endorsed, we recognize that
the NQF endorsement process is an important part of measure development
and plan to submit this measure for NQF endorsement. As noted, this
quality measure will fill a gap by holding hospices to a higher
standard of care and will motivate providers to conduct a greater
number of high priority care processes for as many beneficiaries as
possible upon admission as hospice patients. Furthermore, no current
NQF-endorsed measures address the completion of a comprehensive care
assessment at hospice admission.
Form, Manner, and Timing of Data Collection and Submission. The
data source for this measure will be currently implemented HIS items
that are currently used in the calculation of the 7 component measures.
These items and quality measure algorithms for the 7 component measures
can be found in the HQRP Specifications for the Hospice Item Set-based
Quality Measures document, which is available in the ``Downloads''
section of the ``Current Measures'' portion of the CMS HQRP Web site:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-QualityReporting/Current-Measures.html. Since the
proposed measure is a composite measure whose components are currently
adopted HQRP measures, no new data collection will be required; data
for the composite measure will come from existing items from the
existing 7 HQRP component measures. CMS proposes to begin calculating
this measure using existing data items, beginning April 1, 2017; this
means patient admissions occurring after April 1, 2017 would be
included in the composite measure calculation.
Since the composite measure components are existing HIS data items,
providers are already collecting the data needed to calculate the
composite measure. Data collection will continue in accordance with
processes outlined in sections III.C.7c through III.C.7e of this rule.
For more information on the specifications and data elements for
the measure, Hospice and Palliative Care Composite Process Measure-
Comprehensive Assessment at Admission, we refer readers to the https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html document,
available on the ``Current Measures''
[[Page 52171]]
portion of the CMS HQRP Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html.
We received multiple comments pertaining to the Hospice and
Palliative Care Composite Process Measure. The following is a summary
of the comments we received on this topic and our responses.
Comment: CMS received many comments in support of the proposed
Hospice and Palliative Care Composite Process Measure--Comprehensive
Assessment at Admission quality measure. Commenters appreciated that
the measure demonstrates greater variation in hospice performance than
the individual component measures, and that it can be used to
differentiate performance across hospices. Commenters also appreciated
that CMS's measure selection activities for the HQRP take into
consideration input from stakeholders such as the Measure Applications
Partnership (MAP). Several commenters were supportive of CMS's approach
to quality measure development in the HQRP, specifically, the use of
Technical Expert Panels (TEP) to obtain expert and other stakeholder
input.
Response: We thank commenters for their support of the proposed
Hospice and Palliative Care Composite Process Measure--Comprehensive
Assessment at Admission quality measure, herein after referred to as
the `Composite QM'.
Comment: Many comments were received regarding the retirement of
the seven day length of stay exclusion for six of the care process
measures that comprise the Composite QM. Commenters' primary concern
focused on the impact of removing this exclusion on provider behavior;
specifically, commenters suggested that eliminating the LOS exclusion
may inappropriately incentivize providers to focus on completion and
compliance with the HIS requirements at the expense of addressing the
needs and preferences of imminently dying patients. Commenters noted
that upon admission for imminently dying patients, a comprehensive
assessment is not in the interest of patients and caregivers, nor may
it be feasible for hospices to deliver because the focus is on
appropriately directed to other priorities. One commenter stated that
the level and intensity of hospices services are different for patients
with short LOS and that the items captured in this measure are not
reflective of quality of care for patients imminently dying. Finally,
one commenter indicated that this measure might complicate data
collection efforts and processes already in place at hospices, noting
that different members of the interdisciplinary team often complete
different sections of the HIS at different times. This commenter
believed that hospices would therefore need to establish new data
collection processes when addressing urgent patient/family needs should
be the priority. In response to these concerns, commenters requested
that provisions be made to account for patients with short LOS and
suggested alternative approaches to do so. Namely, commenters
recommended that CMS risk adjust or stratify for patients with a 2-day
or less, 3-day or less, or 5-day or less LOS, while other comments
recommended that CMS maintain the current 7-day LOS exclusion. Another
commenter recommended that a new measure be created to capture data for
short LOS patients, rather than including them in this measure.
Commenters requested clarification on why the measure was not created
with risk adjustment in its current specifications.
Response: We appreciate the commenters' input on the Composite QM
LOS exclusion specifications. Developing and adopting measures that
benefit patient outcomes and do not lead to negative unintended
consequences of the utmost importance to CMS. We would like to take
this opportunity to respond to commenters' concerns about the impact of
retiring the LOS exclusion, first by describing the history of the LOS
exclusion and the reason for retiring it from the individual measures.
As many commenters noted, 6 of the 7 component quality measure (QMs)
exclude patient stays that are less than 7 days from the measure
denominator. At the time the measures were developed, no national data
regarding the implications of the LOS exclusion was available at that
time, and technical experts recommended that short patient stays be
excluded from those measures' denominators for assessing quality of
care. Since the implementation of the HIS, we have performed
descriptive analyses to examine the implications of the LOS exclusion
on hospices' denominator size and QM scores. Additionally, this
analysis also examined the timing of when hospices perform the care
processes assessed in the quality measures. The results of these
analyses demonstrated that the denominator sizes for the HQRP QMs are
largely impacted by the current 7 day LOS exclusion used to calculate
the QMs. Excluding stays with LOS less than 7 days result in many
hospices not having sufficient denominator size to allow for public
display of their quality scores. Although the LOS exclusion has a
sizable impact on the number of hospices eligible to have their data
publicly displayed, the impact of the LOS exclusions on the
distribution of hospices' scores is generally small for all of the QMs.
Therefore, removing the LOS exclusion criteria will increase the number
of hospices eligible for public reporting while having a minimal impact
on the QM scores. In addition, these analyses revealed that the care
processes targeted by the QMs are performed on the day of or within one
day of admission for the vast majority of patient stays. For example,
among patient admissions for which a pain screening was administered,
approximately 92 percent of screenings occurred on the day of admission
and close to 99 percent occurred within 1 day of admission. This
suggests that including stays of less than 7 days in QM calculations
(that is, removing the QM LOS exclusion) may be appropriate and would
not create a burden on hospices. In response to these results, the
measure developer and steward submitted the individual QMs to the NQF
Palliative Care and End of Life Project for re-endorsement in February
2016 without the LOS exclusion. Because of the anticipated removal of
the LOS exclusion for the current HQRP measures (component measures for
this Composite QM), this Composite QM was proposed without the LOS
exclusion in order to be consistent with the individual measure
components. Our contractor convened a TEP in December 2015 to inform
the development of the Composite QM. The TEP, presented with the
results of the LOS analysis, strongly recommended that the Composite QM
maintain the same measure specifications as the individual measures.
Additionally, this TEP considered the creation of a separate measure
specifically for short LOS patients, as recommended by a commenter, but
ultimately agreed that such a measure would not capture comprehensive
care for short LOS patients as the current proposed measure would.
Furthermore, we remind commenters that because the Composite QM is
based on the 7 current HIS measures that are already endorsed by NQF,
risk adjustment for the Composite QM will be consistent with any risk
adjustment created and applied for the individual measures. Any
additional risk adjustment applied to the individual measures will
first be developed and tested for in coordination with the NQF prior to
[[Page 52172]]
implementation. We will keep the commenters' recommendations and
concerns regarding short LOS in mind for future development efforts and
data analysis.
Comment: CMS received comments regarding the contribution of this
measure to quality of care. While commenters did not object to the
development and implementation of this measure, many were concerned
whether this measure is truly reflective of comprehensive care at
admission and whether it will provide patients and families with
meaningful information.
Response: We appreciate the commenters' concern regarding the
impact and relevance of the Composite QM. We are committed to the
ensuring that all quality measures implemented in the HQRP meet the
goals of the HQRP, which include distinguishing performance among
hospices and improving patient outcomes. We regularly conduct measure
testing and evaluation activities to ensure that measures continue to
demonstrate improvements in-patient care. We would like to convey to
commenters that a primary motivation in developing the Composite QM is
to provide interpretable and meaningful information to consumers. We
believe that, above and beyond information provided by the individual
component QMs, the Composite QM accomplishes this by providing
consumers with a single measure regarding the overall quality and
completeness of assessment of patient needs at hospice admission, which
can then be used to compare quality across hospice providers and
increase transparency, while also accessing information about hospice
performance on each of the individual measures that comprise the
Composite QM. As also noted in this rule, the Composite QM demonstrates
greater variation in hospice performance than individual measures.
Hospice performance scores on the current 7 HQRP measures are high (a
score of 90 percent or higher on most measures); however, on average, a
much lower percentage of patient stays in a hospice had documentation
that all 7 of these care processes were completed at admission.
Additionally, we would like to reiterate that the Composite QM for
comprehensive assessment at admission addresses high priority aspects
of comprehensive quality hospice care as identified by both leading
hospice stakeholders and beneficiaries receiving hospice services, all
of which emphasize attention to physical, psychosocial, emotional, and
spiritual needs of patients.
Comment: CMS received a few comments recommending that CMS attain
NQF endorsement of the Composite QM prior to implementation.
Response: We appreciate the commenters' input and support of the
NQF endorsement process. Our paramount concern is the successful
development of a HQRP that promotes the delivery of high quality
healthcare services. We seek to adopt measures for the HQRP that
promote patient-centered and high quality care. Our measure selection
activities for the HQRP take into consideration input from the Measure
Applications Partnership (MAP), convened by the NQF, as part of the
established CMS pre-rulemaking process required under section 1890A of
the Act. The NQF MAP met on December 14th and 15th, 2015 and encouraged
continued development of this measure. Additionally, while this measure
is not currently NQF-endorsed, we recognize that the NQF endorsement
process is an important part of measure development and plan to submit
this measure for NQF endorsement. This quality measure will fill a gap
by holding hospices to a higher standard of care and will motivate
providers to conduct a greater number of high priority care processes
for as many beneficiaries as possible upon admission as hospice
patients--a unique contribution to hospices. Furthermore, no current
NQF-endorsed measures address the completion of a comprehensive care
assessment at hospice admission, and this measure is a first step
towards that goal. We are establishing the timeline for seeking NQF
endorsement for this quality measure and will communicate this timeline
to the public in future rulemaking cycles.
Comment: CMS received one comment requesting clarification on the
logic behind including NQF #1617 Patients Treated with an Opioid Who
Are Given a Bowel Regimen measure as a component measure of the
proposed Composite QM. This commenter indicated that the NQF #1617
measure does not collect data representative of comprehensive care on
the first day of admission and, therefore, does not serve this measure
well as a component.
Response: We would like to clarify that the Composite QM is not
designed to focus on care processes completed on the first day of
admission; rather, this measure is intended to capture all
comprehensive assessment activities around the time of hospice
admission. This timeframe is in line with guidelines identified the
Medicare Hospice Conditions of Participation (CoPs).\30\ The Medicare
CoPs mandate that an initial assessment be completed within 48 hours
after the election of hospice care and that a comprehensive assessment
be completed no later than 5 calendar days after the election of
hospice care is in accordance with Sec. 418.24. Therefore, by
collecting data beyond the first day of admission, this measure aligns
with the practices recommended by the CoPs and with national guidelines
and clinical recommendations. The Medicare CoPs require that both the
hospice initial and comprehensive assessments identify patients'
physical needs and address them to promote the hospice patients' well-
being and comfort throughout the dying process. Additionally, the
Quality Palliative Care Clinical Practice Guidelines \31\ produced by
the National Consensus Project (NCP) established eight core palliative
care domains, one of which emphasizes the assessment and management of
pain and/or other physical symptoms. This measure captures care
processes related to bowel management and opioid use. Most patients
prescribed opioids to manage pain or other symptoms develop some degree
of constipation after opioid initiation or dose increases. Reducing
opioid-induced constipation can reduce patient discomfort and improve
quality of life. Properly assessing and managing symptoms related to
bowel management are critical components of the comprehensive
assessment. Therefore, by including the NQF #1617 measure in this
comprehensive assessment, we address high priority aspects of quality
hospice care as identified by leading hospice stakeholders.
---------------------------------------------------------------------------
\30\ Medicare and Medicaid Programs: Hospice Conditions of
Participation, Part 418 subpart 54. Centers for Medicare and
Medicaid Services (2008).
\31\ Clinical Practice Guidelines for Quality Palliative Care.
National Consensus Project for Quality Palliative Care (2013).
---------------------------------------------------------------------------
Comment: CMS received one comment recommending that the title of
this measure, specifically the term ``at admission'', be clarified or
replaced. The commenter believed that the use of the phrase ``at
admission'' was misleading since it seemed to imply that the measure
captures care processes completed on the day of admission. Since the
composite measure in fact captures care processes completed during the
initial and/or comprehensive assessment (which, per CoP requirements,
must be completed within 2 and 5 days from admission, respectively),
the commenter believed the title of the measure could be misleading
since care processes that are components of the measure may be
completed beyond the day of admission.
[[Page 52173]]
Response: We would like to thank this commenter for their
recommendation. We would like to clarify that this measure title was
developed based on the CoP requirement for the comprehensive
assessment. While it is true that the CoPs require the first
comprehensive assessment to be completed within 5 days of admission,
the CoPs also require hospices to update the comprehensive assessment
as frequently as the condition of the patient requires, but no less
frequently than every 15 days. Thus, we used the phrase Comprehensive
Assessment ``at Admission'' to denote that this measure and the data it
captures refers to care processes delivered during the first
comprehensive assessment completed upon admission to hospice and not
any subsequent comprehensive assessment updates.
Comment: CMS received a few comments regarding the measure
specifications of the Composite QM. Commenters requested clarification
on the composite measure score calculation, construction, and
components.
Response: The Composite QM is a composite measure that assesses
whether a comprehensive patient assessment is completed at hospice
admission by evaluating whether seven critical individual care
processes were completed upon admission for each hospice patient stay.
A composite measure, as defined by the NQF, is a combination of two or
more component measures, each of which individually reflects quality of
care, into a single performance measure with a single score. For more
information on composite measure definitions, guiding principles, and
measure evaluation criteria, we refer readers to the NQF Composite
Performance Measure Evaluation Guidance Publication available at
https://www.qualityforum.org/Publications/2013/04/Composite_Performance_Measure_Evaluation_Guidance.aspx. A total of 7
individual care processes will be captured in this Composite QM, which
include the 6 NQF endorsed quality measures and 1 modified NQF endorsed
quality measure currently implemented in the HQRP. This Composite QM
calculates the percentage of patients who received all applicable care
processes at admission. For additional details on the draft Composite
QM specifications, we refer readers to the HQRP Specifications for HIS-
Based QM document, available on the ``Current Measures'' portion of the
CMS HQRP Web site: https://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/HospiceQuality-Reporting/CurrentMeasures.html. This measure, therefore, reflects the variation
in hospices' performance on all 7 quality measures for each patient at
admission. We will continue the development and analyses of the
Composite QM. Potential refinement to the measure specifications will
be communicated with the public via HQRP communication channels,
including postings and announcements on the CMS HQRP Web site, MLN
eNews communications, national provider association calls, and
announcements on Open Door Forums and Special Open Door Forums.
Comment: CMS received a few comments recommending that CMS be
mindful of public awareness of differences between process and outcome
measures when creating a composite measure. Two commenters stated that
although this measure concept is valuable and consistent with existing
clinical guidelines, knowledge about differences in hospice measure
types is minimal among the public. The commenter noted that the public
might not be able to understand the relationship of hospice performance
on the Composite QM to quality of care delivery at the hospice.
Additionally, two commenters recommended that to aid consumer
understanding of information from the Composite QM, CMS should
supplement this data with information from the hospice CAHPS survey.
Response: We appreciate the commenters' feedback on public
usability of the Composite QM. We would like to highlight that one
primary motivation for creating this Composite QM was to provide
interpretable and meaningful information to consumers. We believe the
Composite QM may be easier for consumers to understand because it
provides the public with a single metric regarding care processes at
admission as compared to the individual component QMs. As such, QM
scores can be easily used to compare quality across providers and make
informed decisions. We are committed to providing all users with the
necessary information to understand the intent and application of
measures in the HQRP. As with other measures, we will conduct measure
testing and reportability analysis to determine if the Composite QM is
appropriate for public reporting. Should we determine the Composite QM
is appropriate for public reporting, we would take necessary steps to
ensure that any data publicly reported is meaningful and understandable
by the public. Such steps may include usability testing and cognitive
interviewing. We also plan to make hospice CAHPS quality measures
publicly available to consumers.
Final Action: After consideration of the comments, we are
finalizing our proposal to implement the Hospice and Palliative Care
Composite Process Measure--Comprehensive Assessment at Admission
effective April 1, 2017.
Table 16--Proposed Quality Measures and Data Collection Period Affecting the FY 2019 Payment Determination and Subsequent Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data
Quality measure NQF ID No. Type Submission method collection to
begin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hospice Visits when Death is Imminent TBD...................... Process Measure................... Hospice Item Set.................. 04/01/2017
Hospice and Palliative Care Composite TBD......................
Process Measure.
--------------------------------------------------------------------------------------------------------------------------------------------------------
7. 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.
b. Previously Finalized Policy for New Facilities To Begin Submitting
Quality Data
In the FY 2015 Hospice Wage Index final rule (79 FR 50488), we
finalized a policy stating that any hospice that receives its CMS
Certification Number (CCN) (also known as the Medicare Provider Number)
notification letter
[[Page 52174]]
dated on or after November 1 of the preceding year involved is excluded
from any payment penalty for quality reporting purposes for the
following FY. This requirement was codified at Sec. 418.312.
In the FY 2016 Hospice Wage Index final rule (80 FR 47189), we
further clarified and finalized our policy for the timing of new
providers to begin reporting data to CMS. The clarified policy
finalized in the FY 2016 Hospice Wage Index final rule (80 FR 47189)
distinguished between when new hospice providers are required to begin
submitting HIS data and when providers will be subject to the potential
2 percentage point annual payment update (APU) reduction for failure to
comply with HQRP requirements. In summary, the policy finalized in the
FY 2016 Hospice Wage Index final rule (80 FR 47189 through 47190)
clarified that providers must begin submitting HIS data on the date
listed in the letterhead of the CCN Notification letter received from
CMS but will be subject to the APU reduction based on whether the CCN
Notification letter was dated before or after November 1 of the
reporting year involved. Thus, beginning with the FY 2018 payment
determination and for each subsequent payment determination, we
finalized our policy that a new hospice be responsible for HQRP quality
data submission beginning on the date of the CCN notification letter;
we retained our prior policy that hospices not be subject to the APU
reduction if the CCN notification letter was dated after November 1 of
the year involved. For example, if a provider receives their CCN
notification letter and the date in the letterhead is November 5, 2016,
that provider will begin submitting HIS data for patient admissions
occurring after November 5, 2016. However, since the CCN notification
letter was dated after November 1st, they would not be evaluated for,
or subject to any payment penalties for, the relevant FY APU update
(which in this instance is the FY 2018 APU, which is associated with
patient admissions occurring 1/1/16-12/31/16).
This policy allows CMS to receive HIS data on all patient
admissions on or after the date a hospice receives their CCN
notification letter, while at the same time allowing hospices
flexibility and time to establish the necessary accounts for data
submission before they are subject to the potential APU reduction for a
given reporting year. Currently, new hospices may experience a lag
between Medicare certification and receipt of their actual CCN Number.
Since hospices cannot submit data to the QIES ASAP system without a
valid CCN Number, CMS proposed that new hospices begin collecting HIS
quality data beginning on the date noted on the CCN notification
letter. We believe this policy will provide sufficient time for new
hospices to establish appropriate collection and reporting mechanisms
to submit the required quality data to CMS. Requiring quality data
reporting beginning on the date listed in the letterhead of the CCN
notification letter aligns CMS policy for requirements for new
providers with the functionality of the HIS data submission system
(QIES ASAP).
c. Previously Finalized Data Submission Mechanism, Collection
Timelines, and Submission Deadlines for the FY 2017 Payment
Determination
In the FY 2015 Hospice Wage Index final rule (79 FR 50486), we
finalized our policy requiring that, for the FY 2017 reporting
requirements, hospices must complete and submit HIS records for all
patient admissions to hospice after July 1, 2014. For each HQRP program
year, we require that hospices submit data on each of the adopted
measures in accordance with the reporting requirements specified in
sections III.C.7c through III.C.7e of that rule for the designated
reporting period. This requirement applies to previously finalized and
adopted measures, as well as new measures proposed through the
rulemaking process. Electronic submission is required for all HIS
records. Although electronic submission of HIS records is required,
hospices do not need to have an electronic medical record to complete
or submit HIS data. In the FY 2014 Hospice Wage Index final rule (78 FR
48258), we finalized a provision requiring that providers can use
either the Hospice Abstraction Reporting Tool (HART) (which is free to
download and use) or vendor-designed software to complete HIS records.
HART provides an alternative option for hospice providers to collect
and maintain facility, patient, and HIS Record information for
subsequent submission to the QIES ASAP system. Once HIS records are
complete, electronic HIS files must be submitted to CMS via the QIES
ASAP system. Electronic data submission via the QIES ASAP system is
required for all HIS submissions; there are no other data submission
methods available. Hospices have 30 days from a patient admission or
discharge to submit the appropriate HIS record for that patient through
the QIES ASAP system. CMS will continue to make HIS completion and
submission software available to hospices at no cost. We provided
details on data collection and submission timing under the downloads
section of the HIS Web site on the CMS.gov Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html.
The QIES ASAP system provides reports upon successful submission
and processing of the HIS records. The final validation report may
serve as evidence of submission. This is the same data submission
system used by nursing homes, inpatient rehabilitation facilities, home
health agencies, and long-term care hospitals for the submission of
Minimum Data Set Version 3.0 (MDS 3.0), Inpatient Rehabilitation
Facility-patient assessment instrument (IRF-PAI), Outcome Assessment
Information Set (OASIS), and Long-Term Care Hospital Continuity
Assessment Record & Evaluation Data Set (LTCH CARE), respectively. We
have provided hospices with information and details about use of the
HIS through postings on the HQRP Web site, Open Door Forums,
announcements in the CMS MLN Connects Provider e-News (E-News), and
provider training.
d. Previously Finalized Data Submission Timelines and Requirements for
FY 2018 Payment Determination and Subsequent Years
Hospices are evaluated for purposes of the quality reporting
program based on whether or not they submit data, not on their
substantive performance level for the required quality measures. In
order for CMS to appropriately evaluate the quality reporting data
received by hospice providers, it is essential HIS data be received in
a timely manner.
The submission date is the date on which the completed record is
submitted and accepted by the QIES ASAP system. In the FY 2016 Hospice
Wage Index final rule (80 FR 47191), CMS finalized our policy that
beginning with the FY 2018 payment determination hospices must submit
all HIS records within 30 days of the event date, which is the
patient's admission date for HIS-Admission records or discharge date
for HIS-Discharge records.
For HIS-Admission records, the submission date must be no later
than the admission date plus 30 calendar days. The submission date can
be equal to the admission date, or no greater than 30 days later. The
QIES ASAP system will issue a warning on the Final Validation Report if
the submission date is more than 30 days after the patient's admission
date.
[[Page 52175]]
For HIS-Discharge records, the submission date must be no later
than the discharge date plus 30 calendar days. The submission date can
be equal to the discharge date, or no greater than 30 days later. The
QIES ASAP system will issue a warning on the Final Validation Report if
the submission date is more than 30 days after the patient's discharge
date.
The QIES ASAP system validation edits are designed to monitor the
timeliness of submission and ensure that providers' submitted records
conform to the HIS data submission specifications. Providers are
notified when timing criteria have not been met by warnings that appear
on their Final Validation Reports. A standardized data collection
approach that coincides with timely submission of data is essential to
establish a robust quality reporting program and ensure the scientific
reliability of the data received.
In the FY 2016 Hospice Wage Index final rule (80 FR 47191), CMS
also clarified the difference between the completion deadlines and the
submission deadlines. Current sub-regulatory guidance produced by CMS
(for example, HIS Manual, HIS trainings) states that the completion
deadlines for HIS records are 14 days from the Event Date for HIS-
Admission records and 7 days from the Event Date for HIS-Discharge
records. Completion deadlines continue to reflect CMS guidance only;
these guidelines are not statutorily specified and are not designated
through regulation. These guidelines are intended to offer clear
direction to hospice agencies in regards to the timely completion of
HIS-Admission and HIS-Discharge records. The completion deadlines
define only the latest possible date on which a hospice should complete
each HIS record. This guidance is meant to better align HIS completion
processes with clinical workflow processes; however, hospices may
develop alternative internal policies to complete HIS records. Although
it is at the discretion of the hospice to develop internal policies for
completing HIS records, CMS continues to recommend that providers
complete and attempt to submit HIS records early, prior to the
previously finalized submission deadline of 30 days, beginning in FY
2018. Completing and attempting to submit records early allows
providers ample time to address any technical issues encountered in the
QIES ASAP submission process, such as correcting fatal error messages.
Completing and attempting to submit records early will ensure that
providers are able to comply with the 30 day submission deadline. HQRP
guidance documents, including the CMS HQRP Web site, HIS Manual, HIS
trainings, Frequently Asked Questions, and Fact Sheets, continue to
offer the most up-to-date CMS guidance to assist providers in the
successful completion and submission of HIS records. Availability of
updated guidance will be communicated to providers through the usual
CMS HQRP communication channels, including postings and announcements
on the CMS HQRP Web site, MLN eNews communications, national provider
association calls, and announcements on Open Door Forums and Special
Open Door Forums.
e. Previously Finalized HQRP Data Submission and Compliance Thresholds
for the FY 2018 Payment Determination and Subsequent Years
To accurately analyze quality reporting data received by hospice
providers, it is imperative we receive ongoing and timely submission of
all HIS-Admission and HIS-Discharge records. In the FY 2016 Hospice
Wage Index final rule (80 FR 47192), CMS finalized the timeliness
criteria for submission of HIS-Admission and HIS-Discharge records. The
finalized timeliness criteria was in response to input from our
stakeholders seeking additional specificity related to HQRP compliance
affecting FY payment determinations and, due to the importance of
ensuring the integrity of quality data submitted.
Last year, we finalized our policy (80 FR 47191 through 47192) that
beginning with the FY 2018 payment determination and subsequent FY
payment determinations, all HIS records would have to be submitted
within 30 days of the event date, which is the patient's admission date
or discharge date. In conjunction with this requirement, we also
finalized our policy (80 FR 47192) to establish an incremental
threshold for compliance over a 3-year period. To be compliant for the
FY 2018 APU determination, hospices must submit no less than 70 percent
of their total number of HIS-Admission and HIS-Discharge records by no
later than 30 days from the event date. The timeliness threshold is set
at 80 percent for the FY 2019 APU determination and at 90 percent for
the FY 2020 APU determination and subsequent years. The threshold
corresponds with the overall amount of HIS records received from each
provider that fall within the established 30 day submission timeframes.
Our ultimate goal is to require all hospices to achieve a compliance
rate of 90 percent or more.
To summarize, in the FY 2016 Hospice Wage Index final rule (80 FR
47193), we finalized our policy to implement the timeliness threshold
requirement beginning with all HIS admission and discharge records that
occur after January 1, 2016, in accordance with the following schedule.
Beginning January 1, 2016 to December 31, 2016, hospices
must submit at least 70 percent of all required HIS records within the
30 day submission timeframe for the year or be subject to a 2
percentage point reduction to their market basket update for FY 2018.
Beginning January 1, 2017 to December 31, 2017, hospices
must submit at least 80 percent of all required HIS records within the
30 day submission timeframe for the year or be subject to a 2
percentage point reduction to their market basket update for FY 2019.
Beginning January 1, 2018 to December 31, 2018, hospices
must submit at least 90 percent of all required HIS records within the
30 day submission timeframe for the year or be subject to a 2
percentage point reduction to their market basket update for FY 2020.
Timely submission of data is necessary to accurately analyze
quality measure data received by providers. To support the feasibility
of a hospice to achieve the compliance thresholds, CMS's measure
development contractor conducted some preliminary analyses of Quarter 3
and Quarter 4 HIS data from 2014. According to this analysis, the vast
majority of hospices (92 percent) would have met the compliance
thresholds at 70 percent. Moreover, 88 percent and 78 percent of
hospices would have met the compliance thresholds at 80 percent and 90
percent, respectively. CMS believes this analysis is further evidence
that the compliance thresholds are reasonable and achievable by hospice
providers.
The current reports available to providers in the Certification and
Survey Provider Enhanced Reports (CASPER) system do allow providers to
track the number of HIS records that are submitted within the 30 day
submission timeframe. Currently, submitting an HIS record past the 30
day submission timeframe results in a non-fatal (warning) error. In
April 2015, CMS made available 3 new Hospice Reports in CASPER, which
include reports that can list HIS Record Errors by Field by Provider
and HIS records with a specific error number. CMS is working on
expanding this functionality of CASPER reports to include a timeliness
compliance threshold report that
[[Page 52176]]
providers could run to determine their preliminary compliance with the
timeliness compliance requirement. CMS expects these reports to be
available by late fall of 2016.
In the FY 2016 Hospice Wage Index final rule (80 FR 47192 through
47193), CMS provided clarification regarding the methodology used in
calculating the 70 percent/80 percent/90 percent compliance thresholds.
In general, HIS records submitted for patient admissions and discharges
occurring during the reporting period (January 1st to December 31st of
the reporting year involved) will be included in the denominator for
the compliance threshold calculation. The numerator of the compliance
threshold calculation would include any records from the denominator
that were submitted within the 30 day submission deadline. In the FY
2016 Hospice Wage Index final rule (80 FR 47192), CMS also stated we
would make allowances in the calculation methodology for two
circumstances. First, the calculation methodology will be adjusted
following the applicable reporting period for records for which a
hospice is granted an extension or exemption by CMS. Second,
adjustments will be made for instances of modification/inactivation
requests (Item A0050. Type of Record = 2 or 3). Additional helpful
resources regarding the timeliness compliance threshold for HIS
submissions can be found under the downloads section of the Hospice
Item Set Web site at CMS.gov at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html. Lastly, as further details of the data
submission and compliance threshold are determined by CMS, we
anticipate communicating these details through the regular CMS HQRP
communication channels, including postings and announcements on the CMS
HQRP Web site, MLN eNews communications, national provider association
calls, and announcements on Open Door Forums and Special Open Door
Forums.
Comment: A few commenters commented on our previously finalized
policies for form, manner, and timing of data collection. One commenter
raised concern about the ability of hospices to comply with the
incremental 70 percent/80 percent/90 percent timeliness compliance
threshold in cases of natural disasters. Specifically, the commenter
was concerned that in the case of protracted natural disasters (for
example, Hurricane Sandy), hospice organizations may not be able to
email CMS within the 30-day timeframe to request an extension or
exemption as appropriate, and that, in turn, failure to submit a timely
request for extension or exemption may put a hospice at risk of non-
compliance with the timeliness threshold. Another commenter stated they
believed the process for HIS data collection and submission, which
relies heavily on chart abstraction, was error-ridden and outdated. The
commenter encouraged CMS to automate data collection and submission
processes via electronic submission of HIS data.
Response: We thank the commenters for their comments on our
previously finalized policies for form, manner, and timing of data
collection. Regarding the first commenter's concern about ability to
submit a timely extension or exemption request to maintain compliance
with the 70/80/90 timeliness compliance thresholds in the case of
extended natural disasters, CMS refers readers to our previously
finalized policies for extensions and exemptions, addressed in section
III.C.8 of this rule. As noted in section III.C.8, in instances of
extraordinary circumstances (like widespread natural disasters), we may
grant an extension/exemption to hospices that have not requested them,
which may include instances where hospices are unable to make the
request within the 30-day timeframe due to extenuating circumstances.
Regarding the second commenter's request for electronic data collection
and submission processes for the HIS, we would like to clarify that, as
noted in section III.C.7.c of this rule, electronic submission of HIS
records is already required; no other data submission methods are
available. Hospices are required to submit all HIS records through the
QIES ASAP system. We also provide electronic software to hospices free
of charge that allows hospices to complete HIS records electronically;
alternatively, hospices may choose to use vendor-designed software to
complete HIS records. As noted by the commenter, we believe this
electronic process of data completion and submission minimizes burden
on providers and helps ensure data quality through the HIS record
validation process. We refer readers to section III.C.7.c for more
information on mechanisms of data submission for the HIS.
f. New Data Collection and Submission Mechanisms Under Consideration
for Future Years
CMS has made great progress in implementing the objectives set
forth in the quality reporting and data collection activities required
by sections 3004 of the Affordable Care Act. To date, CMS has
established the HQRP, which includes 7 NQF-endorsed quality measures
that are collected via the HIS. As stated in this rule, data on these
measures are expected to be publicly reported sometime in 2017.
Additionally, CMS has also implemented the Hospice CAHPS[supreg] as
part of the HQRP to gather important input on patient experience of
care in hospice. Over the past several years, CMS has conducted data
collection and analysis on hospice utilization and trends to help
reform the hospice payment system. In the FY 2016 Hospice Wage Index
final rule, we finalized payment reform measures, including changes to
the RHC payment rate and the implementation of a Service Intensity Add-
On (SIA) payment, effective January 1st, 2016. As part of payment
reform and ongoing program integrity efforts, we will continue ongoing
monitoring of utilization trends for any future refinements.
To facilitate continued progress towards the requirements set forth
in section 3004 of the Affordable Care Act, CMS is considering
developing a new data collection mechanism for use by hospices. This
new data collection mechanism would be a hospice patient assessment
instrument, which would serve 2 primary objectives concordant with the
Affordable Care Act legislation: (1) To provide the quality data
necessary for HQRP requirements and the current function of the HIS;
and (2) provide additional clinical data that could inform future
payment refinements.
CMS believes that the development of a hospice patient assessment
tool could offer several benefits over the current mechanisms of data
collection for quality and payment purposes, which include the
submission of HIS data and the submission of claims data. For future
payment refinements, a hospice patient assessment tool would allow CMS
to gather more detailed clinical information, beyond the patient
diagnosis and comorbidities that are currently reported on hospice
claims. As stated in the FY 2016 Hospice Wage Index final rule (80 FR
47203), detailed patient characteristics are necessary to determine
whether a case mix payment system could be achieved. A hospice patient
assessment tool would allow CMS to capture information on symptom
burden, functional status, and patient, family, and caregiver
preferences, all of which will inform future payment refinements.
While systematic assessment is vital throughout the continuum of
care, including palliative and end-of-life care, documentation
confirming completion
[[Page 52177]]
of systematic assessment in hospice settings is often inadequate or
absent.\32\ The value of the introduction of structured approaches via
a clinical assessment is well established, as it enables a more
comprehensive and consistent way of identifying and meeting patient
needs.\33\
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\32\ McMillan, S., Small, B., & Haley, W. (2011). Improving
Hospice Outcomes through Systematic Assessment: A Clinical Trial.
Cancer Nursing, 34(2), 89-97.
\33\ Bourbonnais, F.F., Perreault, A., & Bouvette, M. (2004).
Introduction of a pain and symptom assessment tool in the clinical
setting--lessons learned. Journal of Nursing Management, 12(3), 194-
200.
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Moreover, symptoms are the leading reason that people seek medical
care in the first place and frequently serve as the basis for
establishing a diagnosis. Measures of physical function and disease
burden have been used to identify older adults at high-risk for excess
health care utilization, disability, or mortality.\34\ Currently, data
collected on claims includes line-item visits by discipline, General
Inpatient Care (GIP) visit reporting to hospice patients in skilled
nursing facilities or hospitals, post-mortem visits, injectable and
non-injectable drugs and infusion pumps. Industry representatives have
communicated to CMS that required claims information is not
sufficiently comprehensive to accurately reflect the provision and the
cost of hospice care.
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\34\ Sha, M., Callahan, C., Counsell, S., Westmoreland, G.,
Stump, T., Kroenke, K. (2005). Physical symptoms as a predictor of
health care use and mortality among older adults. 118, 301-306.
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For quality data collection, a hospice patient assessment
instrument would support the goals of the HQRP as new quality measures
are developed and adopted. Since the current quality data collection
tool (HIS) is a chart abstraction tool, not a hospice patient
assessment instrument, CMS is limited in the types of data that can be
collected via the HIS. Instead of retrospective data collection
elements, a hospice patient assessment tool would include data elements
designed to be collected concurrent with provision of care. As such,
CMS believes a hospice patient assessment tool would allow for more
robust data collection that could inform development of new quality
measures that are meaningful to hospice patients, their families and
caregivers, and other stakeholders.
Finally, a hospice patient assessment tool that provides clinical
data that is used for both payment and quality purposes would align the
hospice benefit with other care settings that use similar approaches,
such as nursing homes, inpatient rehabilitation facilities, and home
health agencies which submit data via the MDS 3.0, IRF-PAI, and OASIS,
respectively.
CMS envisions the hospice patient assessment tool itself as an
expanded HIS. The hospice patient assessment tool would include current
HIS items, as well as additional clinical items that could be used for
payment refinement purposes or to develop new quality measures. The
hospice patient assessment tool would not replace existing requirements
set forth in the Medicare Hospice CoPs (such as the initial nursing and
comprehensive assessment), but would be designed to complement data
that are collected as part of normal clinical care. If such a patient
assessment were adopted, the new data collection effort would replace
the current HIS, but would not replace other HQRP data collection
efforts (that is, the Hospice CAHPS[supreg] survey), nor would it
replace regular submission of claims data. CMS envisions that patient
assessment data would be collected upon a patient's admission to and
discharge from any Medicare-certified hospice provider; additional
interim data collection efforts are also possible. Should CMS develop
and implement a hospice patient assessment tool, CMS would provide
several training opportunities to ensure providers are able to comply
with any new requirements.
CMS is not proposing a hospice patient assessment tool at this
time; we are still in the early stages of development of an assessment
tool to determine if it would be feasible to implement under the
Medicare Hospice Benefit. In the development of such a hospice patient
assessment tool, CMS will continue to receive stakeholder input from
MedPAC and ongoing input from the provider community, Medicare
beneficiaries, and technical experts. It is of the utmost importance to
CMS to develop a hospice patient assessment tool that is scientifically
rigorous and clinically appropriate, thus we believe that continued and
transparent involvement of stakeholders is critical. Additionally, it
is of the utmost importance to CMS to minimize data collection burden
on providers; in the development of any hospice patient assessment
tool, CMS will ensure that patient assessment data items are not
duplicative or overly burdensome to providers, patients, caregivers, or
their families.
We received multiple comments pertaining to a potential hospice
patient assessment tool to collect quality, clinical and other data
with the ability to be used to inform future payment refinement
efforts. The following is a summary of the comments we received on this
topic and our responses.
Comment: CMS received many comments about the potential new data
collection mechanism--a comprehensive, standardized hospice patient
assessment instrument--under consideration for future years. Overall,
the vast majority of commenters were supportive of CMS's efforts to
develop a patient assessment tool. Commenters believed that a patient
assessment tool capturing information on symptom burden, functional
status, and patient, family, and caregiver preferences has the
potential to more accurately inform future payment refinements and
quality measure development based on the needs of the populations
served. Commenters noted that the development of a patient assessment
tool would be an integral step in improving care management and
coordination across settings, providing standardized data on the
services that patients and families receive to better understand the
complex patient characteristics. One of the commenters, MedPAC,
supported the development of a patient assessment instrument, noting
its potential value in capturing more meaningful quality data, as well
as providing more detailed clinical information that might be useful
for payment policy.
Commenters offered several suggestions for CMS to consider in
moving forward with the development of a patient assessment tool.
Suggestions focused on two main themes: (1) Considerations for the
content of any patient assessment tool (2) considerations for the
process used by CMS to develop and test a patient assessment tool.
Beyond these two themes, commenters also listed other considerations,
including cross-setting considerations (experience with other
assessment tools and relationship to the IMPACT Act), burden and costs,
use for future payment refinements, and general concerns.
Regarding considerations for the content of a patient assessment
tool, overall, commenters emphasized the unique nature and care goals
of hospice, urging CMS to bear in mind these complexities in the
development of a patient assessment. Specifically, commenters stated
that the patient assessment tool should reflect the holistic nature of
hospice care delivery to the patient and their loved ones and should
include physical, psychosocial, and spiritual components. Commenters
also noted that the unit of care in hospice is the patient and family,
and that the initial and ongoing assessment, as well as care planning
and
[[Page 52178]]
interventions, address the holistic care needs of both the patient and
family. Commenters urged CMS not to limit the focus of a patient
assessment tool to the clinical, ``head-to-toe'' nursing assessment,
since care plans in hospice are often ``more personal than medical''
with emphasis on the patient's family and environment. Similarly,
commenters pointed out the interdisciplinary nature of hospice, and
recommended that any patient assessment tool include information from
the entire hospice team. In consideration of all of these factors,
commenters ultimately urged CMS to develop data elements that are
relevant and meaningful to hospice practice.
In addition to comments about the nature and goals of hospice care,
several commenters also had specific content suggestions for CMS to
consider in the development of a patient assessment tool:
Several commenters recommended that the assessment tool
recognize the patient's right to refuse or defer offered services and
the importance of an individualized plan of care.
Several commenters recommended that the assessment tool
accommodate care delivered in various settings, including nursing
homes, assisted living facilities, hospitals, hospice facilities, and
the patient's home.
Several commenters recommended that the assessment tool
allow for modified assessment of patients who are imminently dying to
facilitate a focus on the urgent and immediate needs of the patient and
family. Commenters noted that for imminently dying patients, the focus
is the management of symptoms and the family's emotions, not
necessarily a detailed medical history and physical assessment of the
patient.
Several commenters noted that the assessment tool should
preserve the integrity of the hospice philosophy by allowing hospice
interdisciplinary team members to individualize assessments and care
based on their best clinical judgment. Additionally, commenters
recommended that CMS not place overly restrictive limits on members of
the interdisciplinary team that are permitted to complete the
assessment tool. Commenters recommended that CMS allow several
disciplines to contribute patient information and goals on the
assessment, noting that this was a limitation of other assessment
tools.
One commenter recommended that CMS collect assessment data
beyond the admission and discharge time points discussed in the
proposed rule (81 FR 25528). The commenter noted the importance of
measuring care throughout the entire stay, not just at admission and
discharge.
Commenters recommended that any outcome measure derived
from the assessment be risk-adjusted.
A couple of commenters suggested that any ``Reason for
Discharge'' item(s) on the assessment tool differentiate the reason
behind any live discharges (for example, revoked vs. moved out of
service area).
One commenter recommended CMS consider the International
Classification of Function (ICF), in the development of a patient
assessment tool. The commenter noted that the ICF provides a scientific
basis for understanding health and health-related states as well as
outcomes, related to both physical as well as social determinants, and
could be a way to determine appropriate outcomes more quickly. Finally,
the commenter noted that the ICF is already integrated into the ICD-10
and ICD-11 taxonomy internationally.
Another commenter recommended that CMS align any new
hospice assessment tool with the National Consensus Project for Quality
Palliative Care Clinical Practice Guidelines for Quality Palliative
Care.
Commenters had several suggestions regarding the process for
development of any patient assessment tool. The majority of comments on
the process for assessment tool development focused on systematically
and comprehensively gathering input from hospice providers and other
stakeholders with respect to what is appropriate and relevant to
include in the assessment tool. Commenters offered specific suggestions
of ways to involve the provider community, including CMS-convened
technical expert panels (TEP) that include representation from
hospices, physicians, and other members of the hospice
Interdisciplinary Team (IDT). In addition to TEPs, one commenter
suggested that CMS consider extending opportunities for input beyond
TEPs and employ widespread processes for gathering provider input.
Commenters also had suggestions for testing and refinement of a patient
assessment tool. Commenters recommended piloting the tool with a wide
variety of hospices, to ensure that the assessment tool is tested with
variation in hospice size, rurality, state regulatory environments, and
organization type (that is, hospital based, freestanding, those with
inpatient facilities vs. those who contract for inpatient care, etc.).
Commenters recommended a pilot testing process that is thorough and
includes a dry-run period or phased-in implementation approach.
Finally, commenters encouraged CMS to provide thorough and ongoing
education and support for hospices as the patient assessment tool is
implemented. Commenters specifically requested that educational
materials include clear definitions of patient assessment items and
data collection procedures.
Several commenters also discussed their experience with assessment
tools in other care settings (for example, the OASIS in home health and
the MDS in nursing homes). Some commenters expressed concerns about
potential overreliance on existing assessment instrument items citing
the difference in care goals between hospice and other post-acute care
settings. These commenters emphasized the importance of creating an
assessment tool tailored to the unique needs of hospice. On the other
hand, commenters also urged CMS to create an assessment tool that is
aligned and consistent with other assessment tools to facilitate care
coordination and planning across the care continuum.
A few commenters offered considerations on potential burden and
costs of a new assessment instrument. Commenters urged CMS to pursue
efforts that would limit administrative burden, reduce redundancy, and
ensure the use of definitions consistent with other assessment tools.
Commenters noted that the assessment would likely be completed by
different staff than those who are currently completing the HIS-
Admission and HIS-Discharge records and that the assessment would
likely be more time-intensive than the current HIS. Commenters urged
CMS to consider increased costs to providers and to take into
consideration the time and resources necessary to complete the
assessment.
One commenter suggested that CMS--as appropriate--consider
harmonizing measures from the IMPACT Act. The commenter noted that such
harmonization would facilitate communication among providers and to
measure the care of patient populations across setting measures. With
respect to use of the patient assessment for future payment
refinements, a few commenters noted the importance of rigorous testing
of assessment items for inter-rater reliability and validity.
Beyond the support and suggestions offered, some commenters did
raise concerns about a patient assessment tool. Commenters cautioned
against a patient assessment tool that would lead to ``checklist''
assessments and undue restrictions on patient eligibility and the
freedom to employ clinical judgment. Finally, one commenter had
concerns about the flexibility of electronic medical record systems to
capture
[[Page 52179]]
assessment items in a structured and minimally burdensome manner.
Response: First, we thank the commenters for their support of the
development of a patient assessment tool. We agree that development of
a patient assessment tool is a critical next step in refining quality
data collection efforts and to inform future refinements to the hospice
payment system. Second, we greatly appreciate the thoughtful input and
recommendations from the hospice community. We believe the initial
input from our stakeholders regarding the content and process for
development of a patient assessment tool is aligned with our vision and
guiding principles for moving forward with developing this new data
collection mechanism. We would like to assure the provider community
that we wholeheartedly agree with commenters regarding the unique
nature of hospice care, and we intended to keep the hospice philosophy
as the foundation of the patient assessment tool. We seek to develop an
assessment tool that reflects the distinctive aspects of hospice care,
including the palliative, rather than curative, focus of hospice care.
We agree with the points raised by commenters about the overall focus
of an assessment tool and aims to develop a tool that addresses the
holistic nature of hospice, incorporating important medical,
psychosocial, spiritual, and other aspects of care that are important
for patients and their caregivers. We also appreciate commenters'
specific suggestions regarding the content of a patient assessment tool
including the need for a flexible assessment, which would incorporate
input from various members of the IDT and accommodate circumstances
unique to hospice such as care of the imminently dying and patient/
caregivers' right to decline services or treatment.
With respect to commenters' suggestions about the process for
development of a patient assessment tool, we would again like to thank
the hospice community for their detailed input and careful
consideration. Again, we would like to assure the provider community
that it is our intent to use a development process that is transparent
and includes multiple opportunities for stakeholder input. Feedback
from the provider community is vital to the development of a patient
assessment tool that is meaningful and not unduly burdensome on
providers. As noted by commenters and discussed in this rule, CMS plans
to hold TEPs to inform the development, testing, and refinement of the
patient assessment. CMS also plans to provide other opportunities for
stakeholders to provide input through venues such as special open door
forums and other regular HQRP communication channels. We are committed
to a development process that will ensure rigorous and iterative
testing of the patient assessment tool in hospices with varying
organizational characteristics, patient populations, settings of care
delivery, and levels of care. We recognize the emphasis that we will
need to place on thorough testing and analysis of items for reliability
and validity, particularly for purposes of any future payment
refinements. Finally, we agree that ongoing training and education will
be vital, and we will ensure access to regular HQRP education and
outreach outlets, such as training webinars, manuals and access to
various Helpdesks.
We also appreciate commenters' suggestions on cross-setting
harmonization and for sharing their experience with assessment tools in
other care settings. We would like to assure commenters that we
recognize the unique nature of hospice care; it is not our intent to
develop an assessment tool that inappropriately relies on items from
existing tools, such as the Minimum Data Set (MDS) and Outcome and
Information Assessment Information Set (OASIS). We will work diligently
with the provider community to gather information on current assessment
practices in hospice and to ensure that a hospice assessment tool would
capture the goals of hospice care and be complementary to current
clinical practice. Regarding the commenters' suggestion to harmonize
assessment items and resulting quality measure with the IMPACT Act
quality measures, we appreciate the commenter's suggestion and will
take it under consideration for future measure and assessment
development.
Finally, with respect to concerns raised by commenters about costs
and administrative burden, as stated in the rule, it is our goal to
minimize data collection burden on providers and ensure that patient
assessment items are not duplicative or overly burdensome to providers,
patients, or their families. We believe that regular, ongoing input
from the provider community will aide in the development of an
assessment that is not overly burdensome. We expect that development of
the patient assessment will take into account the ongoing movement
toward use of certified EHRs and other interoperable health IT across
all patient settings. We expect that our consultations with providers
and with technical experts including health IT experts will include
assessing and taking advantage of opportunities to develop and deploy
the instrument in a way that integrates with hospice work flows and
with the potential of health IT to help providers improve care,
communication and coordination across the interdisciplinary care team
while reducing burden on clinicians and other care team members by
streamlining data collection and management. In addition, any patient
assessment tool would be submitted to OMB as required by the Paperwork
Reduction Act, the purpose of which is to ensure that Federally-
sponsored data collection efforts pose no undue burden on the public.
We appreciate the input from the public regarding the development
of a patient assessment tool for hospice. We will continue to inform
our stakeholders on any progress and proposals regarding the patient
assessment tool through future rulemaking cycles.
8. HQRP Submission Exemption and Extension Requirements for the FY 2017
Payment Determination and Subsequent Years
In the FY 2015 Hospice Wage Index final rule (79 FR 50488), we
finalized our proposal to allow hospices to request, and for CMS to
grant, exemptions/extensions for the reporting of required HIS quality
data when there are extraordinary circumstances beyond the control of
the provider. When an extension/exemption is granted, a hospice will
not incur payment reduction penalties for failure to comply with the
requirements of the HQRP. For the FY 2016 payment determination and
subsequent payment determinations, a hospice may request an extension/
exemption of the requirement to submit quality data for a specified
time period. In the event that a hospice requests an extension/
exemption for quality reporting purposes, the hospice would submit a
written request to CMS. In general, exemptions and extensions will not
be granted for hospice vendor issues, fatal error messages preventing
record submission, or staff error.
In the event that a hospice seeks to request an exemptions or
extension for quality reporting purposes, the hospice must request an
exemption or extension within 30 days of the date that the
extraordinary circumstances occurred by submitting the request to CMS
via email to the HQRP mailbox at
[email protected]. Exception or extension requests
sent to CMS through any other channel will not be considered valid. The
request for an exemption or extension must contain all of the finalized
requirements as outlined on our Web site at https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-
[[Page 52180]]
Quality-Reporting/Extensions-and-Exemption-Requests.html.
If a hospice is granted an exemption or extension, timeframes for
which an exemption or extension is granted will be applied to the new
timeliness requirement so such hospices are not penalized. If a hospice
is granted an exemption, we will not require that the hospice submit
any quality data for a given period of time. By contrast, if we grant
an extension to a hospice, the hospice will still remain responsible
for submitting quality data collected during the timeframe in question,
although we will specify a revised deadline by which the hospice must
submit these quality data.
This process does not preclude us from granting extensions/
exemptions to hospices that have not requested them when we determine
that an extraordinary circumstance, such as an act of nature, affects
an entire region or locale. We may grant an extension/exemption to a
hospice if we determine that a systemic problem with our data
collection systems directly affected the ability of the hospice to
submit data. If we make the determination to grant an extension/
exemption to hospices in a region or locale, we will communicate this
decision through routine CMS HQRP communication channels, including
postings and announcements on the CMS HQRP Web site, MLN eNews
communications, national provider association calls, and announcements
on Open Door Forums and Special Open Door Forums.
9. Hospice CAHPS[supreg] Participation Requirements for the 2019 APU
and 2020 APU
National Implementation of the Hospice CAHPS[supreg] Survey started
January 1, 2015 as stated in the FY 2015 Hospice Wage Index and Payment
Rate Update final rule (79 FR 50452). The CAHPS[supreg] Hospice Survey
is a component of CMS' Hospice Quality Reporting Program that
emphasizes the experiences of hospice patients and their primary
caregivers listed in the hospice patients' records. Readers who want
more information are referred to our extensive discussion of the
Hospice Experience of Care Survey in the Hospice Wage Index FY 2015
final rule for a description of the measurements involved and their
relationship to the statutory requirement for hospice quality reporting
(79 FR 50450 also refer to 78 FR 48261).
a. Background and Description of the Survey
The CAHPS[supreg] Hospice Survey is the first national hospice
experience of care survey that includes standard survey administration
protocols that allow for fair comparisons across hospices. Consistent
with many other CMS CAHPS[supreg] surveys that are publicly reported on
CMS Web sites, CMS will publicly report hospice data when at least 12
months of data are available, so that valid comparisons can be made
across hospice providers in the United States, in order to help
patients, family, friends, and caregivers choose the right hospice
program.
The goals of the CAHPS[supreg] Hospice Survey are to:
Produce comparable data on hospice patients' and
caregivers' perspectives of care that allow objective and meaningful
comparisons between hospices on domains that are important to
consumers.
Create incentives for hospices to improve their quality of
care through public reporting of survey results.
Hold hospice care providers accountable by informing the
public about the providers' quality of care.
Details regarding CAHPS[supreg] Hospice Survey national
implementation, and survey administration as well as participation
requirements, exemptions from the survey requirement, hospice patient
and caregiver eligibility criteria, fielding schedules, sampling
requirements, and the languages in which is questionnaire, are
available on the CAHPS[supreg] Web site, www.HospiceCAHPSsurvey.org and
in the Quality Assurance Guidelines (QAG) manual, which is also on the
same site and is available for download. Measures from the survey will
be submitted to the NQF for endorsement.
b. Participation Requirements To Meet Quality Reporting Requirements
for the FY 2019 APU
To meet participation requirements for the FY 2019 APU, hospices
must collect survey data on an ongoing monthly basis from January 2017
through December 2017 (inclusive). Data submission deadlines for the
2019 APU can be found in Table 17. The data must be submitted by the
deadlines listed in Table 17 by the hospice's authorized approved CMS
vendor.
Hospices provide lists of the patients who died under their care to
form the sample for the Hospice CAHPS[supreg] Survey. We emphasize the
importance of hospices providing complete and accurate information to
their vendors in a timely manner. Hospices must contract with an
approved Hospice CAHPS[supreg] Survey vendor to conduct the survey on
their behalf. The hospice is responsible for making sure their vendor
meets all data submission deadlines. Vendor failure to submit data on
time will be the responsibility of the hospice.
Table 17--CAHPS[supreg] Hospice Survey Data Submission Dates FY 2018
APU, FY 2019 APU, and FY 2020 APU
------------------------------------------------------------------------
Sample months (that is, month of death) Quarterly data submission
\1\ deadlines \2\
------------------------------------------------------------------------
FY 2018 APU
------------------------------------------------------------------------
January-March 2016 (Q1)................... August 10, 2016.
April-June 2016 (Q2)...................... November 9, 2016.
July-September 2016 (Q3).................. February 8, 2017.
October-December 2016 (Q4)................ May 10, 2017.
------------------------------------------------------------------------
FY 2019 APU
------------------------------------------------------------------------
January-March 2017 (Q1)................... August 9, 2017.
April-June 2017 (Q2)...................... November 8, 2017.
July-September 2017 (Q3).................. February 14, 2018.
October-December 2017 (Q4)................ May 9, 2018.
------------------------------------------------------------------------
FY 2020 APU
------------------------------------------------------------------------
January-March 2018 (Q1)................... August 8, 2018.
[[Page 52181]]
April-June 2018 (Q2)...................... November 14, 2018.
July-September 2018 (Q3).................. February 13, 2019.
October-December 2018 (Q4)................ May 8, 2019.
------------------------------------------------------------------------
1 Data collection for each sample month initiates 2 months following the
month of patient death (for example, in April for deaths occurring in
January).
2 Data submission deadlines are the second Wednesday of the submission
months, which are Augst, November, February, and May.
Hospices that have fewer than 50 survey-eligible decedents/
caregivers in the period from January 1, 2016 through December 31, 2016
are exempt from CAHPS[supreg] Hospice Survey data collection and
reporting requirements for the FY 2019 payment determination. To
qualify, hospices must submit an exemption request form. This form will
be available in first quarter 2017 on the CAHPS[supreg] Hospice Survey
Web site http://www.hospiceCAHPSsurvey.org. Hospices that want to claim
the size exemption are required to submit to CMS their total unique
patient count for the period of January 1, 2016 through December 31,
2016. The due date for submitting the exemption request form for the FY
2019 APU is August 10, 2017.
CMS proposed that hospices that received their CCN after January 1,
2017 are exempted from the FY 2019 APU Hospice CAHPS[supreg]
requirements due to newness. This exemption will be determined by CMS.
The exemption is for 1 year only.
c. Participation Requirements To Meet Quality Reporting Requirements
for the FY 2020 APU
To meet participation requirements for the FY 2020 APU, hospices
must collect survey data on an ongoing monthly basis from January 2018
through December 2018 (inclusive). Data submission deadlines for the
2020 APU can be found in Table 17. The data must be submitted by the
deadlines in Table 17 by the hospice's authorized approved CMS vendor.
Hospices that have fewer than 50 survey-eligible decedents/
caregivers in the period from January 1, 2017 through December 31, 2017
are exempt from CAHPS[supreg] Hospice Survey data collection and
reporting requirements for the FY 2020 payment determination. To
qualify, hospices must submit an exemption request form. This form will
be available in first quarter 2018 on the CAHPS[supreg] Hospice Survey
Web site http://www.hospiceCAHPSsurvey.org. Hospices that want to claim
the size exemption are required to submit to CMS their total unique
patient count for the period of January 1, 2017 through December 31,
2017. The due date for submitting the exemption request form for the FY
2020 APU is August 10, 2018.
CMS proposed that hospices that received their CCN after January 1,
2018 are exempted from the FY 2020 APU Hospice CAHPS[supreg]
requirements due to newness. This exemption will be determined by CMS.
The exemption is for 1 year only.
d. Annual Payment Update
The Affordable Care Act requires that beginning with FY 2014 and
each subsequent fiscal year, 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 fiscal
year, unless covered by specific exemptions. Any such reduction will
not be cumulative and will not be taken into account in computing the
payment amount for subsequent fiscal years. In the FY 2015 Hospice Wage
Index final rule, we added the CAHPS[supreg] Hospice Survey to the
Hospice Quality Reporting Program requirements for the FY 2017 payment
determination and determinations for subsequent years.
To meet the HQRP requirements for the FY 2018 payment
determination, hospices would collect survey data on a monthly basis
for the months of January 1, 2016 through December 31, 2016 to qualify
for the full APU.
To meet the HQRP requirements for the FY 2019 payment
determination, hospices would collect survey data on a monthly basis
for the months of January 1, 2017 through December 31, 2017 to qualify
for the full APU.
To meet the HQRP requirements for the FY 2020 payment
determination, hospices would collect survey data on a monthly basis
for the months of January 1, 2018 through December 31, 2018 to qualify
for the full APU.
e. Hospice CAHPS[supreg] Reconsiderations and Appeals Process
Hospices are required to monitor their respective Hospice
CAHPS[supreg] Survey vendors to ensure that vendors submit their data
on time. The hospice CAHPS[supreg] data warehouse provides reports to
vendors and hospices, including reports on the status of their data
submissions. Details about the reports and emails received after data
submission should be referred to the Quality Assurance Guidelines
Manual. If a hospice does not know how to retrieve their reports, or
lacks access to the reports, they should contact Hospice CAHPS[supreg]
Technical Assistance at [email protected] or call them at 1-
844 -472 -4621. Additional information can be found on page 113 of the
Hospice CAHPS[supreg] Quality Assurance Guidelines manual Version 2.0
which is available on the Hospice CAHPS[supreg] Web site,
www.hospicecahpssurvey.org.
In the FY 2017 payment determination and subsequent years,
reporting compliance is determined by successfully fulfilling both the
Hospice CAHPS[supreg] Survey requirements and the HIS data submission
requirements. Providers would use the same process for submitting a
reconsideration request that are outlined in section III.C.10 of this
rule.
We received multiple comments pertaining to the Hospice
CAHPS[supreg] Survey. The following is a summary of the comments we
received on this topic and our responses.
Comment: One commenter expressed concern about the length of the
survey and described it as a tool that is 36 pages in length and
fraught with arduous stipulations of its delivery. In addition, the
commenter stated that it would be very difficult for CMS to monitor
compliance with how hospices are portraying the survey and described
the survey as cumbersome for bereaved families to complete.
Response: The Hospice CAHPS Survey consists of a total of 47
[[Page 52182]]
questions, some of which are only asked when the patient received
services in a specific setting. The Hospice CAHPS Survey has fewer
questions than NHPCO's well-known Family Evaluation of Hospice Care
(FEHC) survey, which has 54 items. We offer a 36-page document on the
CAHPS Survey Web site that contains survey materials
(www.hospicecahpssurvey.org). The document packages three copies of the
questionnaire, each set up for a different optical scanning program.
This is offered for the convenience of the survey vendors. Vendors will
use only one of these versions. In addition, the file includes some
sample letters for vendors' use. We have implemented detailed
specifications for the survey vendors to follow. This ensures
standardization of survey administration procedures across vendors.
Standardization is important for accurate data quality and to ensure
that the data from different vendors is comparable for public
reporting. While it is true that we have no way to monitor the way
hospices are portraying the survey, we offer guidelines in the Quality
Assurance Guidelines manual on the survey Web site
(www.hospicecahpssurvey.org). We rely on the professionalism of the
providers to cooperate with the survey's requirements.
The commenter also states that the survey is burdensome for
bereaved families to complete. We thank the commenters for their
comments; we have not received complaints from respondents regarding
the survey being burdensome. Responses are voluntary and at the
discretion of the person receiving the survey. If they find the survey
too burdensome, they simply do not need to respond.
Comment: A few commenters stated that it is unclear whether public
reporting will use only the eligible HIS quality measures or will also
use the Hospice CAHPS results. Commenters claim that the inclusion of
Hospice CAHPS results is essential if Hospice Compare is to provide a
meaningful reflection of hospice care quality.
Response: We thank the commenters for their comments. We are
currently building the infrastructure for the new Hospice Compare site
and are evaluating the best method to include both the Hospice Item Set
measures and the results of the Hospice CAHPS Survey.
Comment: One commenter made the point that, for smaller hospices,
Hospice CAHPS data is likely to be more vulnerable to variations
numerator size and variability than comparable data for larger
hospices.
Response: We agree that smaller hospices may be subject to greater
variability than large ones. We plan to report an eight-quarter rolling
average for Hospice CAHPS public reporting. For the initial report, we
may include fewer quarters, but we will build up to eight quarters and
continue on an ongoing basis. These plans are intended to
counterbalance concerns about variability of the data while at the same
time including as many hospices as possible on the Compare site.
Comment: One commenter recommended that CMS conduct analysis to
determine how CAHPS results are affected by survey eligibility
requirements and response rates. Specifically, they express concern
about the relationship between Hospice CAHPS data and the data that
would be obtained if survey eligibility rules were modified.
Response: We thank the commenter for their comments. When a sample
is taken, it is a random sample to represent the care of all eligible
hospice patients. We do exclude patients who have been in hospice care
for fewer than 48 hours since their caregivers do not have enough
experience to evaluate the care provided by the hospice. We intend to
conduct a variety of special and ongoing analyses of Hospice CAHPS
data, as well as other related data available to the agency, including
analyses of how non-responders differ from responders to determine if
we need to control for non-response bias. Generally, the adjustment is
already completed for differences in the mix of patients across
providers also controls for any non-response bias. We will, however,
continue to monitor how eligibility requirements and response rates
impact the character of the data reported and whether changes in
requirements need to be made.
Comment: A few commenters commented that hospices not included in
public reporting might be disadvantaged.
Response: As mentioned previously, we are aware that hospices might
want to be included in the Hospice Compare Web site. We are increasing
the number of quarters included in the rolling average that will be
reported on the public reporting site. The goal of this process is to
make it possible for a larger proportion of hospices to be included on
the site, while at the same time limiting the variability of the
results for smaller hospices.
Comment: One commenter requested that CMS use two individual
questions from the survey, the hospice rating item and the
``willingness to recommend'' item, on the Hospice Compare Web site.
Response: We plan to include both the hospice rating question and
the willingness to recommend question as part of the Hospice CAHPS data
reported on Hospice Compare.
Final Action: After consideration of comments, we are finalizing
our proposals that hospices that receive their CCN after January 1,
2017 for the FY 2019 APU and January 1, 2018 for the FY 2020 APU are
exempted from the Hospice CAHPS[supreg] requirements due to newness.
10. HQRP Reconsideration and Appeals Procedures for the FY 2017 Payment
Determination and Subsequent Years
In the FY 2015 Hospice Wage Index final rule (79 FR 50496), we
notified hospice providers on how to seek reconsideration if they
received a noncompliance decision for the FY 2016 payment determination
and subsequent years. A hospice may request reconsideration of a
decision by CMS that the hospice has not met the requirements of the
Hospice Quality Reporting Program for a particular period.
We clarified that any hospice that wishes to submit a
reconsideration request must do so by submitting an email to CMS
containing all of the requirements listed on the HQRP Web site at
http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Reconsideration-Requests.html.
Electronic email sent to [email protected] is the
only form of submission that will be accepted. Any reconsideration
requests received through any other channel including the United States
Postal Service or phone will not be considered as a valid
reconsideration request. We codified this process at Sec. 418.312(h).
In addition, we codified at Sec. 418.306(b)(2) 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 and
solicited comments on all of the proposals and the associated
regulations text at Sec. 418.312 and in Sec. 418.306 in section VI.
Official instructions regarding the payment reduction reconsideration
process can be located under the Regulations and Guidance,
Transmittals, 2015 Transmittals Web site at https://www.cms.gov/
Regulations-and-Guidance/Guidance/Transmittals/2015-Transmittals-Items/
[[Page 52183]]
R52QRI.html?DLPage=1&DLEntries=10&DLSort=4&DLSortDir=descending.
In the past, only hospices found to be non-compliant with the
reporting requirements set forth for a given payment determination
received a notification from CMS of this finding along with
instructions for requesting reconsideration in the form of a United
States Postal Service (USPS) letter. In the FY 2016 Hospice Wage Index
final rule (80 FR 47198), we stated that we would use the QIES CASPER
reporting system as an additional mechanism to communicate to hospices
regarding their compliance with the reporting requirements for the
given reporting cycle. We will implement this additional communication
mechanism via the QIES CASPER timeliness compliance reports referenced
in section III.C.7e of this final rule. As stated in section III.C.7e
of the rule, these QIES CASPER reports will be automated reports that
hospices will be able to generate at any point in time to determine
their preliminary compliance with HQRP requirements, specifically, the
timeliness compliance threshold for the HIS. We believe the QIES CASPER
timeliness compliance reports meet CMS's intent of developing a method
to communicate as quickly, efficiently, and broadly as possible with
hospices regarding their preliminary compliance with reporting
requirements. We will continue to send notification of noncompliance
via delivery of a letter via the United States Postal Service.
Requesting access to the CMS systems is performed in 2 steps. Details
are provided on the QIES Technical Support Office Web site at https://www.qtso.com/hospice.html. Providers may access the CMS QIES Hospice
Users Guides and Training by going to the QIES Technical Support Office
Web site and selecting Hospice and then selecting the CASPER Reporting
Users Guide at https://www.qtso.com/hospicetrain.html. Additional
information about how to access the QIES CASPER reports will be
provided prior to the availability of these new reports.
We proposed to disseminate communications regarding the
availability of hospice compliance reports in CASPER files through CMS
HQRP communication channels, including postings and announcements on
the CMS HQRP Web site, MLN eNews communications, national provider
association calls, and announcements on Open Door Forums and Special
Open Door Forums. We further proposed to publish a list of hospices who
successfully meet the reporting requirements for the applicable payment
determination on the CMS HQRP Web site https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/index.html. We proposed updating the list after
reconsideration requests are processed on an annual basis. We clarified
that the published list of compliant hospices on the CMS HQRP Web site
would include limited organizational data, such as the name and
location of the hospice. Finalizing the list of compliant providers for
any given year is most appropriately done after the final determination
of compliance is made. It is our intent for the published list of
compliant hospices to be as complete and accurate as possible, giving
recognition to all providers who were compliant with HQRP requirements
for that year. Finalizing the list after requests for reconsideration
are reviewed and a final determination of compliance is made allows for
a more complete and accurate listing of compliant providers than
developing any such list prior to reconsideration. Developing the list
after the final determination of compliance has been made allows
providers whose initial determination of noncompliance was reversed to
be included in the list of compliant hospices for that year. We believe
that finalizing the list of compliant hospices annually after the
reconsideration period will provide the most accurate listing of
hospices compliant with HQRP requirements.
11. Public Display of Quality Measures and Other Hospice Data for the
HQRP
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. Such procedures shall ensure that a
hospice program has the opportunity to review the data that is to be
made public for the hospice program prior to such data being made
public. The Secretary shall report quality measures that relate to
hospice care provided by hospice programs on the CMS Web site.
We recognize that public reporting of quality data is a vital
component of a robust quality reporting program and are fully committed
to developing the necessary systems for transparent public reporting of
hospice quality data. We also recognize that it is essential that the
data made available to the public be meaningful and that comparing
performance between hospices requires that measures be constructed from
data collected in a standardized and uniform manner. Hospices have been
required to use a standardized data collection approach (HIS) since
July 1, 2014. Data from July 1, 2014 onward is currently being used to
establish the scientific soundness of the quality measures prior to the
onset of public reporting of the 7 quality measures implemented in the
HQRP. We believe it is critical to establish the reliability and
validity of the quality measures prior to public reporting to
demonstrate the ability of the quality measures to distinguish the
quality of services provided. To establish reliability and validity of
the quality measures, at least four quarters of data will be analyzed.
Typically, the first 1 or 2 quarters of data reflect the learning curve
of the facilities as they adopt standardized data collection
procedures; these data often are not used to establish reliability and
validity. We began data collection in CY 2014; the data from CY 2014
for Quarter 3 (Q3) was not used for assessing validity and reliability
of the quality measures. We analyzed data collected by hospices during
Quarter 4 (Q4) CY 2014 and Q1 through Q3 CY 2015. Preliminary analyses
of HIS data show that all 7 quality measures that can be calculated
using HIS data are eligible for public reporting (NQF #1634, NQF #1637,
NQF #1639, NQF #1638, NQF #1641, modified NQF #1647, NQF #1617). Based
on analyses conducted to establish reportability of the measures, 71
percent through 90 percent of all hospices would be able to participate
in public reporting, depending on the measure. For additional details
regarding analysis, we refer readers to the Measure Testing Executive
Summary document available on the ``Current Measures'' section of the
CMS HQRP Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html. Although analyses show that many hospices perform well
on the 7 measures from the HIS measure set, the measures still show
variation, especially among hospices with suboptimal performance,
indicating that these measures are still meaningful for comparing
quality of care across hospice providers. In addition to conducting
quantitative analysis to establish scientific acceptability of the HIS
measures, CMS's measure development contractor conducted interviews
with family and caregivers of hospice patients. The purpose of these
interviews was to determine what information patients and caregivers
would find useful in selecting hospices, as well as gathering input
about patient and caregiver experience with hospice
[[Page 52184]]
care. Results from these interviews indicate that all 7 HIS quality
measures provide consumers with useful information. Interview
participants stated that quality measure data would be especially
helpful in identifying poor quality outliers that inform beneficiaries,
families, caregivers, and other hospice stakeholders.
To inform which of the HIS measures are eligible for public
reporting, CMS's measure development contractor, RTI International,
examined the distribution of hospice-level denominator size for each
quality measure to assess whether the denominator size is large enough
to generate the statistically reliable scores necessary for public
reporting. This goal of this analysis is to establish the minimum
denominator size for public reporting, which is referred to as
``reportability'' analysis. Reportability analysis is necessary since
small denominators may not yield statistically meaningful QM scores.
Thus, for other quality reporting programs, such as Nursing Home
Compare,\35\ CMS sets a minimum denominator size for public reporting,
as well as the data selection period necessary to generate the minimum
denominator size. Reportability analysis showed that calculating and
publicly displaying measures based on 12 months of data would allow for
sufficient measure denominator size. Having ample denominator size
ensures that quality measure scores that are publicly reported are
reliable and stable; a minimum sample size of 20 stays is commonly
applied to assessment-based quality measures in other reporting
programs. The 12-month data selection period produced significantly
larger mean and median sample sizes among hospices, which will generate
more reliable quality measure scores. Additionally, our analysis
revealed that when applying a minimum sample size of 20 stays, using
rolling 12 months of data to create QMs would only exclude about 10
percent through 29 percent of hospices from public reporting, depending
on the measure. For more information on analyses conducted to determine
minimum denominator size and data selection period, we refer readers to
the Reportability Analysis Section of the Measure Testing Executive
Summary, available on the ``Current Measures'' portion of the CMS HQRP
Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html.
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\35\ ``CMS Nursing Home Quality Initiative--Centers for Medicare
. . .'' 2011. 25 Jan. 2016 https://www.cms.gov/nursinghomequalityinits/45_nhqimds30trainingmaterials.asp.
---------------------------------------------------------------------------
Based on reportability analysis and input from other stakeholders,
we have determined that all 7 HIS measures are eligible for public
reporting. Thus, we plan to publicly report all 7 HIS measures on a CMS
Compare Web site for hospice agencies. For more details on each of the
7 measures, including information on measure background, justification,
measure specifications, and measure calculation algorithms, we refer
readers to the HQRP QM User's Manual, which is available on the
downloads portion of the Current Measures CMS HQRP Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html. Individual
scores for each of the 7 HIS measure scores would be reported on a new
publicly available CMS Hospice Compare Web site. Current reportability
analysis indicates that a minimum denominator size of 20 based on 12
rolling months of data would be sufficient for public reporting of all
HIS quality measures. Under this methodology, hospices with a quality
measure denominator size of smaller than 20 patient stays would not
have the quality measure score publicly displayed since a quality
measure score on the basis of small denominator size may not be
reliable. We will continue to monitor quality measure performance and
reportability and will adjust public reporting methodology in the
future if needed.
Reportability analysis is typically conducted on a measure-by-
measure basis. We would like to clarify that any new measure adopted as
part of the HQRP will undergo reportability analysis to determine: (1)
If the measure is eligible for public reporting; and (2) the data
selection period and minimum denominator size for the measure. Results
of reportability analyses conducted for new measures will be
communicated through future rulemaking.
In addition, the Affordable Care Act requires that reporting be
made public on a CMS Web site and that providers have an opportunity to
review their data prior to public reporting. We are currently
developing the infrastructure for public reporting and will provide
hospices an opportunity to review their quality measure data prior to
publicly reporting information about the quality of care provided by
Medicare-certified hospice agencies throughout the nation. These
quality measure data reports or ``preview reports'' will be made
available in the CASPER system prior to public reporting and will offer
providers the opportunity to review their quality measure data prior to
public reporting on the CMS Compare Web site for hospice agencies.
Under this process, providers would have the opportunity to review and
correct data they submit on all measures that are derived from the
Hospice Item Set. Reports would contain the provider's performance on
each measure calculated based on HIS submission to the QIES ASAP
system. The data from the HIS submissions would be populated into
reports with all data that have been submitted by the provider. CMS
will post preview reports with sufficient time for providers to be able
to submit, review data, make corrections to the data, and view their
data. Providers are encouraged to regularly evaluate their performance
in an effort to ensure the most accurate information regarding their
agency is reflected.
We also plan to make available additional provider-level feedback
reports, which are separate from public reporting and will be for
provider viewing only, for the purposes of internal provider quality
improvement. As is common in other quality reporting programs, quality
reports would contain feedback on facility-level performance on quality
metrics, as well as benchmarks and thresholds. For the CY 2015
Reporting Cycle, several new quality reporting provider participation
reports were made available in CASPER. Providers can access a detailed
list and description of each of the 12 reports currently available to
hospices on the QIES Web site, under the Training & Education
Selections, CASPER Reporting Users Guide at https://www.qtso.com/hospicetrain.html. We anticipate that providers would use the quality
reports as part of their Quality Assessment and Performance Improvement
(QAPI) efforts.
Furthermore, to meet the requirement for making such data public,
we are developing a CMS Hospice Compare Web site, which will provide
valuable information regarding the quality of care provided by
Medicare-certified hospice agencies throughout the nation. Consumers
would be able to search for all Medicare approved hospice providers
that serve their city or zip code (which would include the quality
measures and CAHPS[supreg] Hospice Survey results) and then find the
agencies offering the types of services they need, along with provider
quality information. Based on the efforts necessary to build the
infrastructure for public reporting, we anticipate that public
reporting of the eligible HIS quality measures on the CMS Compare Web
site for hospice
[[Page 52185]]
agencies will begin sometime in the spring/summer of CY 2017. To help
providers prepare for public reporting, we will offer opportunities for
stakeholder engagement and education prior to the rollout of a Hospice
Compare site. We will offer outreach opportunities for providers
through the MLN eNews, Open Door Forums and Special Open Door Forums;
we will also post additional educational materials regarding public
reporting on the CMS HQRP Web site. Finally, we will offer training to
all hospice providers on the systems and processes for reviewing their
data prior to public reporting; availability of trainings will be
communicated through the regular CMS HQRP communication channels,
including postings and announcements on the CMS HQRP Web site, MLN
eNews communications, national provider association calls, and
announcements on Open Door Forums and Special Open Door Forums.
Like other CMS Compare Web sites, the Hospice Compare Web site
will, in time, feature a quality rating system that gives each hospice
a rating of between 1 and 5 stars. Hospices will have prepublication
access to their own agency's quality data, which enables each agency to
know how it is performing before public posting of data on the Hospice
Compare Web site. Public comments regarding how the rating system would
determine a hospice's star rating and the methods used for
calculations, as well as a proposed timeline for implementation will be
announced via regular CMS HQRP communication channels, including
postings and announcements on the CMS HQRP Web site, MLN eNews
communications, provider association calls, and announcements on Open
Door Forums and Special Open Door Forums. We will announce the timeline
for development and implementation of the star rating system in future
rulemaking.
Lastly, as part of our ongoing efforts to make healthcare more
transparent, affordable, and accountable for all hospice stakeholders,
the HQRP is prepared to post hospice data on a public data set, the
Data.Medicare.gov Web site, and directory located at https://data.medicare.gov. This site includes the official datasets used on the
Medicare.gov Compare Web sites provided by CMS. In addition, this data
will serve as a helpful resource regarding information on Medicare-
certified hospice agencies throughout the nation. In an effort to move
toward public reporting of hospice data, we will initially post
demographic data of hospice agencies that have been registered with
Medicare. This list will include high-level demographic data for each
agency including, provider name, address, phone numbers, ownership
type, CMS Certification Number (CCN), profit status, and date of
original CMS certification. The posting of this new hospice data
directory occurred on June 14, 2016. Information can be located at
https://data.medicare.gov/data/hospice-directory. Additional details
regarding hospice datasets will be announced via regular CMS HQRP
communication channels, including postings and announcements on the CMS
HQRP Web site, MLN eNews communications, national provider association
calls, and announcements on Open Door Forums and Special Open Door
Forums. In addition, we have provided the list of CASPER/ASPEN and
Regional Office coordinators in the event the Medicare-certified agency
is either not listed in the database or the characteristics/
administrative data (name, address, phone number, services, or type of
ownership) are incorrect or have changed. To continue to meet Medicare
enrollment requirements, all Medicare providers are required to report
changes to their information in their enrollment application as
outlined in the Provider-Supplier Enrollment Fact Sheet Series located
at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/MedEnroll_InstProv_FactSheet_ICN903783.pdf.
Comment: CMS received several comments that were supportive of
public reporting of hospice quality measures. Commenters noted that
they were in favor of CMS's efforts to publicly report hospice quality
data to support the timely and transparent reporting of HQRP data. One
commenter shared that public reporting of valid and reliable quality
data demonstrates value, underpins compliance, and provides structure
for hospice care. Several commenters did have suggestions,
recommendations, and concerns about specific aspects of the public
display of hospice quality measure data. These specific comments are
summarized below.
Response: We appreciate the commenters' support of public reporting
of hospice quality measures. We address commenters' specific concerns
with respect to public reporting reports below.
Comment: CMS received a few comments expressing concerns that many
hospice providers have high scores on the current HIS measures and some
Hospice CAHPS measures. The potential lack of variation in scores for
these measures may make differentiating between hospice providers'
performance challenging for consumers. Given the limited range of
scores, commenters thought that presenting data as rankings or
percentiles may present results in a way that does not provide valuable
information to consumers. One commenter suggested that CMS consider
risk-adjusting quality measures reported on the Compare Web site.
Response: We agree that all publicly reported data should be
presented in a manner that is meaningful and understandable to the
general public. We will take steps and use recognized practices to
ensure that any publicly reported data is displayed in an appropriate
and meaningful manner. We are developing the format and content for
public display of quality measure data on the Hospice Compare site. We
appreciate the commenters input on how to most meaningfully display
quality measure data and will take these suggestions into consideration
as we finalize the format of public reporting (that is, whether to
report scores or the percentiles for each quality measure (QM)).
Regarding commenters' concerns about the lack of variation in
current HIS measure scores, the overall distribution and variability of
the seven currently adopted HIS QMs is an indicator that most hospices
are providing the required and recommended care to the majority of the
patients around hospice admission, demonstrating overall high quality
of care. However, the seven measures demonstrate room for improvement.
Analysis conducted by our measure development contractor demonstrates
that a low percentage of hospices have perfect scores for most measures
and a small percentage of hospices have very low scores. We believe
this is valuable and important information to communicate to consumers
as well as to providers to motivate quality improvement. Additionally,
we are working on the specific format for publicly reporting these 7
QMs and will take commenters' suggestions into consideration. We agree
that given the skewed distribution, presenting hospice scores in
formats like percentiles may provide misleading information. Presenting
hospices' quality scores may provide information that is more
straightforward for consumers and providers. Finally, input that we
have received from hospice caregivers will also inform our strategy for
public reporting of quality measure data. Our measure development
contractor interviewed hospice caregivers about public display of
quality data and what
[[Page 52186]]
types of data would be most meaningful to consumers. In these
interviews, respondents supported the continued data collection and
reporting of the individual HIS measures, noting that information on
the individual measures is valuable to consumers. Respondents also
noted that although overall performance on the 7 HIS measures is high,
public display of these scores would still be meaningful as a way to
identify low-performing hospices.
With respect to the commenter's suggestion to risk adjust quality
measures reported on the Hospice Compare Web site, we would like to
point out that both the current HIS measure set (NQF #1634, NQF #1637,
NQF #1639, NQF #1638, NQF #1617, NQF #1641 and NQF #1647) and Hospice
CAHPS quality measures are currently under review by the National
Quality Forum (NQF) for maintenance endorsement and endorsement,
respectively. NQF criteria for review and endorsement includes
consideration of risk adjustment. As stated in section III.C.3 of this
rule, it is CMS's intent to implement endorsed quality measures, using
the specifications as endorsed by the NQF.
Comment: A few commenters suggested that CMS provide quarterly
benchmark data to hospices for at least 1 year in advance of publicly
reporting the data. Commenters believed the benchmark data would
demonstrate to individual hospices how they perform compared to all
hospices on the existing measures and allow opportunity for improvement
prior to the onset of public reporting. One commenter shared that
hospices have found stable benchmark scores for comparison to be far
more useful for setting goals and tracking performance improvement.
Response: We appreciate the commenters' suggestion to provide
quarterly benchmark data. As we previously stated, we plan to make
available additional provider-level feedback reports prior to public
reporting; these reports will help hospices with their quality
assessment and performance improvement efforts. As is common in other
quality reporting programs, these reports would provide feedback on
facility-level performance on quality metrics, as well as national
benchmarks. Additionally, national means of the HIS quality measures,
based on Q4 2014 through Q3 2015 HIS data, are reported in the Hospice
Quality Reporting Program: Executive Summary of Measure Testing and
Validation, available on the ``Current Measures'' portion of the CMS
HQRP Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html.
Comment: One commenter urged CMS to not only showcase quality
measures from HIS and Hospice CAHPS, but also demonstrate the scope and
level of services provided by different hospice programs. The commenter
stated that while hospices are required to be able to provide certain
services, patient and family access to these services varies,
especially for the non-clinical services. In addition, this commenter
stated that there is variation in how well hospices meet the
requirements. Moreover, the commenter stated that and a lack of
enforcement allowed lower quality programs to minimally comply with
requirements, if at all. For example, many hospice programs send
mailings to families on bereavement; while this technically meets the
bereavement requirements under the benefit; other hospices offer and
provide robust, individualized bereavement support. The commenter
thought that it would be important for consumers to have information
about these services to help them select a hospice.
Response: We appreciate the commenter's recommendation to report
quality metrics and hospice information beyond HIS and Hospice CAHPS
measures. We recognize that information regarding the scope and level
services provided would be valuable to consumers and hospice providers;
however, we note that such information may not be readily available to
us through billing records or other reporting mechanisms, and we are
cognizant of the burden additional reporting could place on providers.
We will take this recommendation into consideration as we move forward
with the development for future HQRP measures.
Comment: The majority of commenters supported the minimum
denominator size for public reporting. Although commenters were
generally supportive of this requirement, some commenters had concerns
about the possible negative impact on small hospices for which quality
information is not included in public reporting due to not meeting the
minimum denominator size. Commenters noted that hospices who do not
meet the threshold of 20 stays for the HIS-based QMs or the size
exemption for Hospice CAHPS[supreg] Survey, which is less than 50-
survey eligible patients in the previous year, would not be included in
all or part of public reporting. Commenters raised concerns that a lack
of displayed data on Hospice Compare may disadvantage these smaller
providers. Commenters believed that consumers using Hospice Compare to
search for a provider might disregard hospices that do not have some or
all of their data displayed due to size issues, and that, in turn,
consumers may be more likely to seriously consider only those hospices
for which quality information is presented. One commenter expressed
concerns that there are some important statistical considerations, in
addition to denominator size, that should be addressed in creating a
means for public display of hospice quality data. Specifically, the
commenter noted that a small denominator that meets the minimum
denominator size is more sensitive to fluctuations in the numerator
than a large denominator. Smaller hospices are likely to have smaller
denominators and are more vulnerable to numerator size and variability
than larger hospices. The commenters suggested that CMS create a means
to counterbalance the potential negative consequences for those
hospices for which quality information is not included in public
reporting.
Response: We thank the commenters for their support of our
recommendation to set a minimum denominator size for public reporting.
We appreciate commenters sharing concerns regarding the possible
negative impact on small hospices. To establish the minimum denominator
size, we examined the national hospice-level denominator size for the
HIS quality measures. The determination of the minimum denominator size
balanced the necessity of yielding statistically meaningful QM scores
and the goal of allowing as many hospices to have their quality measure
scores publicly displayed as possible. To be consistent with other
quality reporting programs' public reporting policies, we set a minimum
denominator size for public reporting of quality measures, as well as
the data selection period necessary to generate the minimum denominator
size. The minimum denominator size is determined based on a hospice's
patient stays over a 12-month period. Analysis conducted by RTI
International shows that only about 10 percent of hospices would not
have accumulated 20 patient stays to have any HIS quality measure
publicly displayed. RTI's analysis also shows that quality measures
calculated based on 12 months of data are stable and robust against
fluctuation. These results were summarized in the Measure Testing
Executive Summary document referenced in this section of the rule and
posted on the ``Current Measures'' portion of the CMS HQRP Web site:
[[Page 52187]]
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html. On the
Hospice Compare Web site, CMS plans to indicate in some manner (for
example, through a footnote or some other statement) instances where
data is not displayed due to denominator size issues. We believe this
will minimize any potential negative impact on small providers and
signal to consumers that in such instances, the lack of data is a
result of the hospice having too few admissions to allow for reporting
of a valid quality measure, and is not in and of itself an indicator of
hospice quality. Finally, we will take the commenters suggestion
regarding creating a means to counterbalance the potential negative
consequences for small hospices as we move forward with the development
and launch of Hospice Compare.
Comment: CMS received several comments regarding data sources that
would be included in the launch of Hospice Compare. Overall, commenters
offered two main considerations. First, commenters brought up concerns
about the limitations of HIS data for consumer decision-making. Second,
commenters requested clarification from and encouraged CMS to include
Hospice CAHPS data in the launch of Hospice Compare. Regarding the
first concern, commenters noted that HIS data alone might provide
inadequate information to aid in consumer decision-making. Commenters
noted that all HIS measures are process of care measures and, as such,
do not address important issues such as whether the patient/family was
treated with respect or felt supported by the hospice team. They
strongly recommended that the Hospice CAHPS results be reported along
with HIS measures to provide consumers with the most meaningful and
comprehensive picture of quality of care. Finally, commenters
encouraged CMS to provide appropriate disclaimers about the hospice
quality data and information, outlining the limitations of the data and
its utility.
Response: We appreciate the commenters' feedback on public
reporting of HIS and Hospice CAHPS data. We agree with commenters that
HIS and Hospice CAHPS data are complementary and, together, provide a
more meaningful and comprehensive view of quality of care provided by
hospices. As noted in section III.C.9 of this rule, we plan to include
both HIS and Hospice CAHPS data in the launch of Hospice Compare.
Reporting both data sources will address commenters' concerns and
mirrors the approach for public reporting used in other CMS Compare
sites. We will communicate additional plans for the public reporting of
hospice quality data through the usual CMS HQRP communication channels,
including postings and announcements on the CMS HQRP Web site, MLN
eNews communications, national provider association calls, and
announcements on Open Door Forums and Special Open Door Forums.
Comment: A few commenters expressed concerns that consumers will
not understand the difference between a process measure and an outcome
measure and be able to draw conclusions about the experience of hospice
care from just the composite process measure. One commenter shared that
CMS needs to provide education and resources to help the public
understand what the measures mean.
Response: We agree that any publicly reported data should be
presented in a manner that is meaningful and understandable by the
public. We intend to take steps and use recognized practices to ensure
that any publicly reported data is displayed in an appropriate and
meaningful manner. We intend to work with our Web site development
contractor to ensure that the Hospice Compare site has been tested for
usability, readability, and navigation, and that consumers and
stakeholders are continuously involved and have opportunities for input
throughout the development process. We will write in plain language,
with awareness of variations in health and general literacy, and
solicit input from key stakeholders and technical experts in the
development of the presentation of publicly available quality data.
Comment: CMS received a few comments regarding concerns about the
publicly reported HIS measures because they are constructed using HIS
data that is self-reported by hospice providers. Commenters had
concerns about the validity of this data and encouraged CMS to
determine methods to monitor the veracity of the data being submitted.
Commenters noted that the launch of Hospice Compare might create
perverse incentives for hospices to submit false data to avoid
unfavorable scores being publicly reported on the Compare Web site.
Response: We acknowledge commenters' concerns regarding the
validity of self-reported HIS measures. Publicly reported quality
measure data relies on the submission of valid and reliable data at the
patient level. Our measure development contractor conducts ongoing
testing and validation of the quality measure data to identify data
irregularities and trends. We will consider additional validation
processes for future rulemaking cycles.
Comment: CMS received a few comments expressing providers' desire
to review data prior to publication. One commenter inquired about the
process for correcting data errors.
Response: We appreciate the commenters' interest in reviewing data
prior to public reporting. We would like to take this opportunity to
clarify the processes available to providers for reviewing and making
changes to HIS data, and for previewing QM scores prior to public
display. First, as outlined in the HIS Manual, providers have the
opportunity to make corrections to HIS data through HIS record
modification and inactivation processes. HIS record modifications and
inactivations are available if a provider finds an error in HIS data
that has been submitted and accepted by the QIES ASAP system. Further
details on processes for modifications and inactivations are available
in Chapter 3 of the HIS Manual, available on the HIS portion of the CMS
HQRP Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html. It is vital for providers to correct any errors in HIS
data to ensure information in the QIES ASAP system accurately reflects
the patient's hospice record and HIS-related care processes delivered
to the patient; this initial corrections process for errors in HIS data
helps ensure QM scores and any publicly displayed data are accurate.
In addition to modification and inactivation processes available in
QIES ASAP, as we previously stated, we are currently developing the
infrastructure to provide hospices with the opportunity to view their
quality measure data via CASPER provider-level feedback reports. These
internal provider-level feedback reports will provide hospices an
initial opportunity to review QM score data in CASPER. Provider-level
feedback reports are confidential and separate from the public
reporting processes. The purpose of provider-level feedback reports is
to provide hospices with QM score data that can be used at the
individual facility level and for internal quality improvement. We are
planning for release of the QM provider-level feedback reports sometime
in December of 2016. Availability of the new CASPER QM reports will be
communicated to providers through the usual CMS HQRP communication
channels, including postings and announcements on the CMS HQRP Web
site, MLN eNews communications,
[[Page 52188]]
national provider association calls, and announcements on Open Door
Forums and Special Open Door Forums.
Finally, we will ensure providers have the opportunity to preview
QM score data to be displayed on Hospice Compare, prior to public
posting of the data. Prior to public reporting, quality measure data
``preview'' reports will be made available in CASPER system. Hospices
will have a 30-day preview period prior to public display during which
they can preview the performance information on their measures that
will be made public. The ``preview'' reports will be made available
using the Certification and Survey Provider Enhanced Reporting (CASPER)
System because hospices are familiar with this system. In line with
other PAC QRPs, hospices will have 30 days to review this information,
beginning from the date on which they can access the preview report.
Corrections to the underlying data would not be permitted during this
time; however, hospices would be able to ask for a correction to their
measure calculations during the 30-day preview period. If we determine
that the measure, as it is displayed in the preview report, contains a
calculation error, we would suppress the data on the public reporting
Web site, recalculate the measure and publish the corrected rate at the
time of the next scheduled public display date. This process is
consistent with informal processes used in the Hospital IQR and other
PAC programs. Technical details for how and when providers may contest
their measure calculations, as well as the process for submitting a
suppression request will be conveyed through the usual CMS HQRP
communication channels.
Comment: CMS received a comment in support of the initiative to
make available additional provider-level feedback reports in the CASPER
reporting system. The commenter requested CMS consider additional
reports to display quality metric scores that would be available 2 days
after HIS records are submitted and accepted by the QIES ASAP system.
Response: We appreciate the commenter's support of the initiative
to provide additional provider-level feedback reports in CASPER. We
agree that providing timely feedback to hospice providers is a critical
step in the process of quality improvement since providers need data
about their performance to inform QAPI and other performance
improvement efforts. We will continue to refine the provider-level
feedback reports to make timely data available to providers within the
CASPER system.
Comment: One commenter expressed concerns regarding consumers
leaving anonymous negative comments or grievances on the Hospice
Compare Web site. The commenter noted that there is no manner for the
hospice to respond to or rebut negative comments or grievances.
Response: We would like to thank the commenters for taking the time
to convey their concerns regarding consumers leaving anonymous negative
comments or grievances on the Hospice Compare Web site. Consumers will
only be able to search for hospice providers and review quality data;
they will not be able to post comments or grievances on the CMS Hospice
Compare Web site.
Comment: Though commenters were generally supportive of public
reporting of quality data, several commenters expressed concerns over
the methodology for the star rating system to be used in the future as
part of the Hospice Compare Web site. One commenter urged CMS to be
conservative and cautious about the use of star ratings when applied to
Hospice CAHPS data because patient and family experience with care data
is typically positively skewed. A few commenters cautioned CMS against
evaluating hospice providers along a bell curve rather than on a
grading scale when developing star ratings for hospice providers. They
shared that the use of a bell curve creates confusion for consumers and
may misrepresent the quality of the care provided by hospices.
Commenters encouraged CMS to develop a star-rating methodology that
incorporates both HIS and Hospice CAHPS data. A few commenters
suggested that CMS provide sufficient time for stakeholders to review
the star ratings model. One commenter voiced concerns about star-rating
methodologies used in other care settings and recommended CMS take into
consideration lessons learned about unintended consequences when
developing the hospice star rating system. One commenter recommended
that CMS take a criterion approach to constructing the CMS Hospice
Compare Web site and determining the methodology to be used for
calculating star ratings. Another commenter stated that any star rating
system developed should reflect care provided by the entire
interdisciplinary team and should be risk adjusted to account for
individualized care, short lengths of stay and patient right to refuse
care.
Response: We appreciate the thorough and detailed input on the
development of a Hospice Compare Web site and the future development of
a star rating system for hospices. We would like to assure commenters
that it is of paramount concern to develop a star rating methodology
that is valid, is reliable, and presents quality data that is
meaningful to stakeholders. As with the development of star methodology
in other care programs, we will allow continued opportunities for the
provider community and other stakeholders to comment on and provide
input to the proposed rating system. In addition to regular HQRP
communication channels, we will solicit input from the public regarding
star methodology through special listening sessions, invitation to
submit comments via a Help Desk mailbox, Open Door Forums, a Technical
Expert Panel, and other opportunities. Additionally, we will benefit
from lessons learned from the development and implementation of star
ratings in other QRPs to help guide the hospice star rating initiative.
D. The Medicare Care Choices Model
We want to remind the provider community that the Medicare Care
Choices Model (MCCM) is testing a new option for Medicare beneficiaries
with certain advanced diseases to receive hospice-like support services
from MCCM hospices while receiving care from other Medicare providers
for their terminal condition. This 5 year model is being tested to
encourage greater and earlier use of the Medicare and Medicaid hospice
benefit to determine whether it can improve the quality of life and
care received by Medicare beneficiaries, increase beneficiary, family,
and caregiver satisfaction, and reduce Medicare or Medicaid
expenditures. Participation in the model is limited to Medicare and
dual eligible beneficiaries with advanced cancers, chronic obstructive
pulmonary disease, congestive heart failure, and Human Immunodeficiency
Virus/Acquired Immune Deficiency Syndrome who qualify for the Medicare
or Medicaid hospice benefit and meet the eligibility requirements of
the model. The model includes more than 130 hospices from 39 states
across the country and is projected to serve 100,000 beneficiaries by
2020. The first cohort of MCCM participating hospices began providing
services under the model in January 2016, and the second cohort will
begin to provide services under the model in January 2018. The last
patient will be accepted into the model 6 months before the December
31, 2020 model end date.
For more information, see the MCCM Web site: https://innovation.cms.gov/initiatives/Medicare-Care-Choices/.
[[Page 52189]]
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. To
fairly evaluate whether an information collection should be approved by
OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995
requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We solicited public comment on each of the following information
collection requirements (ICRs).
A. Information Collection Requirements
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, manner, and at a time specified
by the Secretary. In the FY 2014 Hospice Wage Index 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 six NQF-endorsed measures and one modified measure 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) (modified).
Data for the aforementioned 7 measures is collected via the HIS.
Data collection for the 7 NQF-endorsed measures via the HIS V1.00.0 was
approved by the Office of Management and Budget April 3, 2014 (OMB
control number 0938-1153--Hospice Quality Reporting Program). As
outlined in this final rule, we continue data collection for these 7
NQF-endorsed measures.
In this final rule, we finalized the implementation of two new
measures. The first measure is the Hospice and Palliative Care
Composite Process Measure--Comprehensive Assessment at Admission. Seven
individual care processes will be captured in this composite measure,
which includes the six NQF-endorsed quality measures and one modified
NQF-endorsed quality measure currently implemented in the HQRP. Thus,
the Hospice and Palliative Care Composite Process quality measure will
use the current HQRP quality measures as its components. The data
source for this measure will be currently implemented HIS items that
are currently used in the calculation of the 7 component measures.
Since the measure is a composite measure created from components, which
are currently adopted HQRP measures, no new data collection will be
required; data for the composite measure will come from existing items
from the existing 7 HQRP component measures. CMS will begin calculating
this measure using existing data items, beginning April 1, 2017; this
means patient admissions occurring on or after April 1, 2017 will be
included in the composite measure calculation.
The second measure is the Hospice Visits when Death is Imminent
Measure Pair. Data for this measure will be collected via the existing
data collection mechanism, the HIS. Four new items will be added to the
HIS-Discharge record to collect the necessary data elements for this
measure. CMS expects that data collection for this quality measure via
the 4 new HIS items will begin no earlier than April 1, 2017. Thus,
under current CMS timelines, hospice providers will begin data
collection for this measure for patient admissions and discharges
occurring on or after April 1, 2017.
The HIS V2.00.0 will fulfill the data collection requirements for
the 7 currently adopted NQF measures and the 2 new measures. The HIS
V2.00.0 contains:
All items from the HIS V1.00.0, which are necessary to
calculate the 7 adopted NQF measures (and thus the composite measure),
plus the HIS V1.00.0 administrative items necessary for patient
identification and record matching,
One new item for measure refinement of the existing
measure NQF #1637 Pain Assessment,
New items to collect data for the Hospice Visits when
Death is Imminent measure pair,
New administrative items for patient record matching and
future public reporting of hospice quality data.
Hospice providers will submit an HIS-Admission and an HIS-Discharge
for each patient admission. Using HIS data for assessments submitted
October 1, 2014 through September 30, 2015, we have estimated that
there will be approximately 1,248,419 discharges across all hospices
per year and, therefore, we would expect that there should be 1,248,419
Hospice Item Sets (consisting of one admission and one discharge
assessment per patient) submitted across all hospices yearly. Over a
three-year period, we expect 3,745,257 Hospice Item Sets across all
hospices. There were 4,259 certified hospices in the U.S. as of January
2016; \36\ we estimate that each individual hospice will submit on
average 293 Hospice Item Sets annually, which is approximately 24
Hospice Items Sets per month or 879 Hospice Item Sets over 3 years.
---------------------------------------------------------------------------
\36\ Quality Improvement and Evaluation System (QIES) List of
Hospice Providers, January 2016.
---------------------------------------------------------------------------
The Hospice Item Set consists of an admission assessment and a
discharge assessment. As noted above, we estimate that there will be
1,248,419 hospice admissions across all hospices per year. Therefore,
we expect there to be 2,496,838 Hospice Item Set assessment submissions
(admission and discharge assessments counted separately) submitted
across all hospices annually, which is 208,070 across all hospices
monthly, or 7,490,514 across all hospices over three years. We further
estimate that there will be 586 Hospice Item Set submissions by each
hospice annually, which is approximately 49 submissions monthly or
1,759 submissions over three years.
For the Admission Hospice Item Set, we estimate that it will take
14 minutes of time by a clinician, such as a Registered Nurse, at an
hourly wage of $67.10 \37\ to abstract data for Admission Hospice Item
Set. This would cost the facility approximately $15.66 for each
admission assessment. We further estimate that it will take 5 minutes
of time by clerical or administrative staff person, such as a medical
data entry clerk or medical secretary, at an hourly wage of $32.24 \38\
to upload the Hospice Item Set data into the CMS system. This would
cost each facility approximately $2.69 per assessment. For the
Discharge Hospice Item Set, we estimate that it
[[Page 52190]]
will take 9 minutes of time by a clinician, such as a nurse, at an
hourly wage of $67.10 to abstract data for Discharge Hospice Item Set.
This would cost the facility approximately $10.07. We further estimate
that it will take 5 minutes of time by clerical or administrative
staff, such as a medical data entry clerk or medical secretary, at an
hourly wage of $32.24 to upload data into the CMS system. This would
cost each facility approximately $2.69. The estimated cost for each
full Hospice Item Set submission (admission assessment and discharge
assessment) is $31.10.
---------------------------------------------------------------------------
\37\ The adjusted hourly wage of $67.10 per hour for a
Registered Nurse was obtained using the mean hourly wage from the
U.S. Bureau of Labor Statistics, $33.55. This mean hourly wage is
adjusted by a factor of 100 percent to include fringe benefits. See
http://www.bls.gov/oes/current/oes291141.htm.
\38\ The adjusted hourly wage of $32.24 per hour for a Medical
Secretary was obtained using the mean hourly wage from the U.S.
Bureau of Labor Statistics, $16.12. This mean hourly wage is
adjusted by a factor of 100 percent to include fringe benefits. See
http://www.bls.gov/oes/current/oes436013.htm.
---------------------------------------------------------------------------
We estimate that the total nursing time required for completion of
both the admission and discharge assessments is 23 minutes at a rate of
$67.10 per hour. The cost across all hospices for the nursing/clinical
time required to complete both the admission and discharge Hospice Item
Sets is estimated to be $32,111,417 annually, or $96,334,252 over 3
years, and the cost to each individual hospice is estimated to be
$7,539.66 annually, or $22,618.98 over 3 years. The estimated time
burden to hospices for a medical data entry clerk to complete the
admission and discharge Hospice Item Set assessments is 10 minutes at a
rate of $32.24 per hour. The cost for completion of the both the
admission and discharge Hospice Item Sets by a medical data entry clerk
is estimated to be $6,708,171 across all hospices annually, or
$20,124,514 across all hospices over 3 years, and $1,575.06 to each
hospice annually, or $4,725.17 to each hospice over 3 years.
The total combined time burden for completion of the Admission and
Discharge Hospice Item Sets is estimated to be 33 minutes. The total
cost across all hospices is estimated to be $38,819,589 annually or
$116,458,766 over 3 years. For each individual hospice, this cost is
estimated to be $9,114.72 annually or $27,344.16 over 3 years. See
Table 18 for breakdown of burden and cost by assessment form.
Table 18--Summary of Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
OMB Number of Burden per Total annual Hourly labor cost Total cost
Regulation section(s) Control No. respondents Number of responses response (hours) burden (hours) of reporting ($) ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hospice Item Set Admission 0938-1153 4,259 1,248,419 per year. 0.233 clinician 395,333 hours..... Clinician at $22,900,166
Assessment. hours; 0.083 $67.10 per hour;
clerical hours. Clerical staff at
$32.24 per hour.
Hospice Item Set Discharge 0938-1153 4,259 1,248,419 per year. 0.150 clinician 291,298 hours..... Clinician at 15,919,423
Assessment. hours; 0.083 $67.10 per hour;
clerical hours. Clerical staff at
$32.24 per hour.
3-year Total.................... 0938-1153 4,259 7,490,514.......... 0.55 hours........ 2,059,891 hours... Clinician at 116,458,766
$67.10 per hour;
Clerical staff at
$32.24 per hour.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
These requirements are not effective until they have been approved by
the OMB.
To obtain copies of the supporting statement and any related forms
for the collections discussed above, please visit CMS's Web site at
https://www.cms.gov/RegulationsandGuidance/Legislation/PaperworkReductionActof1995/PRAListing.html, or call the Reports
Clearance Office at 410-786-1326.
We invited public comments on these potential information
collection requirements. If you wish to comment, please submit your
comments electronically as specified in the ADDRESSES section of this
final rule and identify the rule (CMS-1652-F) the ICR's CFR citation,
CMS ID number, and OMB control number.
Public Comments Received for PRA Package (CMS Form Number--CMS-R-245)
Comment: CMS received one supportive comment indicating that the
additional data sought by CMS for the calculation of the Hospice Visits
when Death is Imminent Measure Pair does not represent a significant
burden on providers and may result in useful information. Other
commenters stated that CMS's burden estimates underestimate the costs
of completing the HIS. One commenter stated that the typical admission
assessment time is 45 minutes to 1 hour, and that staff travel can
significantly increase costs. Another commenter stated that the costs
of training and operational processes to support valid data abstraction
should be included in the burden estimate.
Response: We thank the commenters for their feedback regarding the
burden of the HIS V2.00.0, and the support of the new items used to
collect data for the Hospice Visits when Death is Imminent Measure
Pair. Regarding the cost estimates for the HIS Admission form, the HIS
is a set of data elements that can be used to calculate 7 NQF endorsed
quality measures and 2 new measures adopted in this rule. The HIS is
not a patient assessment that would be directly administered to the
patient and/or family or caregivers during the initial assessment or
comprehensive assessment visit. Since the HIS is not intended to
replace the initial/comprehensive assessment, the PRA burden estimates,
by definition, do not include the time spent assessing the patient. HIS
PRA burden estimates are intended to reflect only the time needed to
complete HIS items, independent of clinical time spent assessing the
patient. Similarly, PRA burden estimates include the Annualized Cost to
the Federal Government related to the HIS V2.00.0 for provider
training, preparation of HIS V2.00.0 manuals and materials, receipt and
storage of data, data analysis, and upkeep of data submission software.
In order to mitigate costs of operational processes, providers may use
the Hospice Abstraction Reporting Tool (HART) software, which is free
to download and use, to collect and maintain facility, patient, and HIS
Record information for subsequent submission to the QIES
[[Page 52191]]
ASAP system. Burden estimates for completing the HIS data items were
based on the HIS V1.00.0 and HIS V2.00.0 pilot tests. We recognize
additional activities and efforts will be required to implement and use
the HIS V2.00.0 as part of the quality reporting program. We agree that
it is important for hospices to learn about and understand the new HIS,
and we plan to provide hospices with training resources to facilitate
implementation of the HIS.
Comment: One commenter stated that the addition of new items to the
HIS Discharge record will require vendor software development and
testing, hospice implementation, education and training, and internal
validation. The commenter stated that the target implementation date of
April 1, 2017 may not provide adequate time for implementation.
Response: We appreciate the commenter's feedback regarding the
timeline for implementation and of the HIS V2.00.0. The HIS V2.00.0 is
undergoing review as part of a PRA package under OMB number 0938-1153
and will be implemented April 1, 2017. We believe the April 1, 2017
implementation date will allow sufficient time for providers to update
their clinical documentation systems and train staff on new HIS items.
The timeline for implementation of the HIS V2.00.0 is consistent with
the timeline from prior years when the HIS V1.00.0 was implemented. We
expect training and implementation activities to take considerably less
time for the HIS V2.00.0 compared to the HIS V1.00.0 since the HIS
V2.00.0 can capitalize on existing infrastructures used by stakeholders
for the HIS V1.00.0 and contains only 17 new item components (compared
to the 60 item components that were implemented in the HIS V1.00.0).
Moreover, we encourage providers to begin preparations for HIS V2.00.0
implementation as soon as possible. The HIS V2.00.0 is currently
available for review by software vendors and hospice providers. Some of
the activities that are necessary prior to implementation can be done
concurrently. For example, hospice education and training on the new
items and data abstraction can be conducted at the same time as vendor
development of software.
We are aware of the effort hospices and vendors will have to make
to prepare for implementation of the HIS. The HIS pilot showed that
implementing the HIS is feasible and that hospices are most likely
already collecting the information needed to complete the HIS data
items. A draft version of the HIS technical data specifications was
posted on the CMS Web site on May 19, 2016. Thus, vendors have been
provided with more than adequate time to develop products for their
clients. We expect vendors to begin reviewing the draft technical data
specifications as soon as they are posted. We encourage vendors to
submit questions and comments to the HIS technical email box:
[email protected]. Software vendors should not be
waiting for final technical data specifications to be posted to begin
development of their own products. Therefore, we believe that vendors
have been provided with adequate time and resources to meet the April
1, 2017 implementation date of the HIS. For providers that currently
use a vendor-designed software to complete HIS records, if a provider
has concerns about the timeliness of release of HIS V2.00.0 items in
vendor-designed software, CMS reminds providers that alternative means
of completing HIS records (HART software) are available to all
providers free of charge. Although electronic submission of HIS records
is required, hospices do not need to have an electronic medical record
to complete or submit HIS data. In the FY 2014 Hospice Wage Index,
final rule (78 FR 48258) we finalized that to complete HIS records
providers can use either the HART software, which is free to download
and use, or vendor-designed software. HART provides an alternative
option for hospice providers to collect and maintain facility, patient,
and HIS Record information for subsequent submission to the QIES ASAP
system. Once HIS records are complete, electronic HIS files must be
submitted to CMS via the QIES ASAP system. Electronic data submission
via the QIES ASAP system is required for all HIS submissions; there are
no other data submission methods available. Hospices have 30 days from
a patient admission or discharge to submit the appropriate HIS record
for that patient through the QIES ASAP system. We will continue to make
HIS completion and submission software available to hospices at no
cost. We provided details on data collection and submission timing
under the downloads section of the HIS Web page on the CMS.gov Web site
at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html.
Comment: One commenter stated that although the burden associated
with the HIS assessment may not be unduly burdensome, the collective
burden of various reporting requirements makes a large fiscal impact on
hospices.
Response: We thank the commenters for taking the time to convey
their concerns about the burden and cost of data collection for the
HQRP and other regulatory requirements. We attempted to reduce the
regulatory burden of our quality reporting programs to the greatest
extent possible. The estimated burden for completing the HIS V2.00.0
can be viewed here: (https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html).
Specifically, CMS estimates 19 minutes per response for the Admission
HIS and 14 minutes per response for the Discharge HIS. Details
regarding the estimate can be found at http://cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
Comments concerning the accuracy of the time estimate(s) or suggestions
for improving the HIS can be directed to: CMS, 7500 Security Boulevard,
Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore,
Maryland 21244-1850. With respect to the commenter's concern about
additional expenses incurred as part of quality reporting, any
additional costs incurred as part of quality reporting programs should
be reported on the cost reports. Cost report data may be considered in
future payment reform.
Comment: One commenter stated that the addition of the J0905 Pain
Active Problem item to the HIS V2.00.0 would be burdensome to hospice
providers since it requires an update to the Admission HIS
documentation and the item will not be used in calculation of the Pain
Assessment measure. The commenter suggested adding the item when a
Patient Reported Outcome Pain Measure is implemented or when a Hospice
Patient Assessment Instrument is developed.
Response: We thank the commenter for their comments regarding the
new item J0905, Pain Active problem. CMS would like to clarify our
reasoning and intent behind the addition of the J0905 Pain Active
Problem item. Since the HIS V1.00.0 was implemented on July 1, 2014,
CMS has received an overwhelming amount of feedback from the provider
community regarding the items in Section J: Pain of the HIS V1.00.0
(J0900. Pain Screening and J0910. Comprehensive Pain Assessment). These
items correspond to the National Quality Forum (NQF) #1634 Pain
Screening quality measure and the NQF #1637 Pain Assessment quality
measure, respectively. NQF #1634 calculates the percentage of
[[Page 52192]]
patients who were screened for pain within two days of admission.
Patients who screen positive for pain are included in the denominator
for NQF #1637, which measures the percentage of patients who screened
positive for pain who received a comprehensive pain assessment within 1
day.
Under current specifications for NQF #1634 and NQF #1637, if a
patient is not in pain at the time of the first screening, that patient
is not included in the denominator for NQF #1637--even if pain is an
active problem for the patient. As such, if a patient is not in current
pain at the time of the first pain screening, HIS V1.00.0 skip patterns
direct providers to skip Item J0910, the comprehensive pain assessment
item. RTI received feedback from the provider community that the
measure specifications and associated skip pattern between J0900 and
J0910 do not align with clinical practice, as clinicians will often
complete a comprehensive pain assessment for patients when pain is an
active problem but the patient is not in pain at the time of the
screening. Providers further noted that some vendor-designed software
built HIS skip patterns into clinical documentation systems and the
skip pattern between J0900 and J0910 was thus restricting the ability
of clinicians to document comprehensive assessments that were conducted
per clinical best practice but not required for the purposes of the HIS
pain quality measures. Due to these factors, CMS has received feedback
from the provider community to consider changing items in the pain
section to align HIS pain items with current clinical practice.
Thus, directly in response to feedback from providers, CMS added
the J0905 Pain Active Problem item to the HIS V2.00.0. We believe this
addition will actually reduce burden on providers since it is better
aligned with current clinical practice. The addition of J0905 also
better aligns items in the pain section with items in Section J:
Respiratory Status. CMS plans to analyze data from J0905 to inform
future potential refinements to the NQF-endorsed pain quality measures.
ICR-related comments are due October 4, 2016.
V. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
We have examined the impacts of this final rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), the Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA, March
22, 1995; Pub. L. 104-4), and the Congressional Review Act (5 U.S.C.
804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. A regulatory impact analysis (RIA) must be prepared for
major rules with economically significant effects ($100 million or more
in any 1 year). This final rule has been designated as economically
significant under section 3(f)(1) of Executive Order 12866 and thus a
major rule under the Congressional Review Act. Accordingly, we have
prepared a regulatory impact analysis (RIA) that, to the best of our
ability, presents the costs and benefits of the rulemaking. This final
rule was also reviewed by OMB.
2. Statement of Need
This final rule meets the requirements of our regulations at Sec.
418.306(c), which requires 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). This final rule will also update payment rates for each
of the categories of hospice care described in Sec. 418.302(b) for FY
2017 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.
In addition, the payment rate updates may be reduced by an additional
0.3 percentage point (although for FY 2014 to FY 2019, the potential
0.3 percentage point reduction is subject to suspension under
conditions specified in section 1814(i)(1)(C)(v) of the Act). In 2010,
the Congress amended section 1814(i)(6) of the Act with section 3132(a)
of the Affordable Care Act. The amendment authorized the Secretary to
revise the methodology for determining the payment rates for routine
home care and other services included in hospice care, no earlier than
October 1, 2013. In the FY 2016 Hospice Wage Index and Rate Update
final rule (80 FR 47164), we finalized the creation of 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
days 61 and over of hospice and created a SIA payment, in addition to
the per diem rate for the RHC level of care, equal to the CHC hourly
payment rate multiplied by the amount of direct patient care provided
by an RN or social worker that occurs during the last 7 days of a
beneficiary's life, if certain criteria are met. Finally, 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.
3. Overall Impacts
We estimate that the aggregate impact of this final rule will be an
increase of $350 million in payments to hospices, resulting from the
hospice payment update percentage of 2.1 percent. The impact analysis
of this final rule represents the projected effects of the changes in
hospice payments from FY 2016 to FY 2017. Using the most recent data
available at the time of rulemaking, in this case FY 2015 hospice
claims data, we apply the current FY 2016 wage index and labor-related
share values to the level of care per diem payments and SIA payments
for each day of hospice care to simulate FY 2016 payments. Then, using
the same FY 2015 data, we apply the FY 2017 wage index and labor-
related share values to simulate FY 2017 payments. 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.
4. Detailed Economic Analysis
The FY 2017 hospice payment impacts appear in Table 19. We tabulate
the resulting payments according to the classifications in Table 19
(for example, facility type, geographic region, facility ownership),
and compare the difference between current and proposed payments to
determine the overall impact.
[[Page 52193]]
The first column shows the breakdown of all hospices by urban or
rural status, census region, hospital-based or freestanding status,
size, and type of ownership, and hospice base. The second column shows
the number of hospices in each of the categories in the first column.
The third column shows the effect of the annual update to the wage
index. This represents the effect of using the FY 2017 hospice wage
index. The aggregate impact of this change is zero percent, due to the
hospice wage index standardization factor. However, there are
distributional effects of the FY 2017 hospice wage index.
The fourth column shows the effect of the hospice payment update
percentage for FY 2017. The 2.1 percent hospice payment update
percentage for FY 2017 is based on an estimated 2.7 percent inpatient
hospital market basket update, reduced by a 0.3 percentage point
productivity adjustment and by a 0.3 percentage point adjustment
mandated by the Affordable Care Act, and is constant for all providers.
The fifth column shows the effect of all the changes on FY 2017
hospice payments. It is projected that aggregate payments will increase
by 2.1 percent, assuming hospices do not change their service and
billing practices in response.
As illustrated in Table 19, the combined effects of all the
proposals vary by specific types of providers and by location. For
example, due to the changes in this rule, the estimated impacts on FY
2017 payments range from a 1.1 percent increase for hospices providing
care in the rural West North Central region to a 2.8 percent increase
for hospices providing care in the rural Pacific region.
Table 19--Projected Impact to Hospices for FY 2017
----------------------------------------------------------------------------------------------------------------
Proposed
Number of Updated wage hospice FY 2017 total
providers data (%) payment change (%)
update (%)
(1) (2) (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
All Hospices.................................... 4,177 0.0 2.1 2.1
Urban Hospices.................................. 3,179 0.0 2.1 2.1
Rural Hospices.................................. 998 -0.1 2.1 2.0
Urban Hospices--New England..................... 138 0.4 2.1 2.5
Urban Hospices--Middle Atlantic................. 252 0.2 2.1 2.3
Urban Hospices--South Atlantic.................. 422 -0.1 2.1 2.0
Urban Hospices--East North Central.............. 399 -0.1 2.1 2.0
Urban Hospices--East South Central.............. 162 -0.1 2.1 2.0
Urban Hospices--West North Central.............. 220 -0.5 2.1 1.6
Urban Hospices--West South Central.............. 616 -0.2 2.1 1.9
Urban Hospices--Mountain........................ 313 -0.3 2.1 1.8
Urban Hospices--Pacific......................... 618 0.6 2.1 2.7
Urban Hospices--Outlying........................ 39 -0.7 2.1 1.4
Rural Hospices--New England..................... 23 -0.4 2.1 1.7
Rural Hospices--Middle Atlantic................. 42 -0.2 2.1 1.9
Rural Hospices--South Atlantic.................. 136 0.2 2.1 2.3
Rural Hospices--East North Central.............. 141 0.1 2.1 2.2
Rural Hospices--East South Central.............. 129 -0.1 2.1 2.0
Rural Hospices--West North Central.............. 186 -1.0 2.1 1.1
Rural Hospices--West South Central.............. 184 -0.1 2.1 2.0
Rural Hospices--Mountain........................ 107 -0.2 2.1 1.9
Rural Hospices--Pacific......................... 47 0.7 2.1 2.8
Rural Hospices--Outlying........................ 3 -0.2 2.1 1.9
0-3,499 RHC Days (Small)........................ 912 0.0 2.1 2.1
3,500-19,999 RHC Days (Medium).................. 2,004 0.0 2.1 2.1
20,000+ RHC Days (Large)........................ 1,261 0.0 2.1 2.1
Non-Profit Ownership............................ 1,071 0.1 2.1 2.2
For Profit Ownership............................ 2,553 -0.1 2.1 2.0
Govt Ownership.................................. 160 0.5 2.1 2.6
Other Ownership................................. 393 -0.1 2.1 2.0
Freestanding Facility Type...................... 3,184 0.0 2.1 2.1
HHA/Facility-Based Facility Type................ 993 0.2 2.1 2.3
----------------------------------------------------------------------------------------------------------------
Source: FY 2015 hospice claims data from the Standard Analytic Files for CY 2014 (as of June 30, 2015) and CY
2015 (as of March 31, 2016).
Region Key:
New England=Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont; Middle
Atlantic=Pennsylvania, New Jersey, New York; South Atlantic=Delaware, District of Columbia, Florida, Georgia,
Maryland, North Carolina, South Carolina, Virginia, West Virginia; East North Central=Illinois, Indiana,
Michigan, Ohio, Wisconsin; East South Central=Alabama, Kentucky, Mississippi, Tennessee; West North
Central=Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota; West South Central=Arkansas,
Louisiana, Oklahoma, Texas; Mountain=Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming;
Pacific=Alaska, California, Hawaii, Oregon, Washington; Outlying=Guam, Puerto Rico, Virgin Islands.
5. Alternatives Considered
Since the hospice payment update percentage is determined based on
statutory requirements, we did not consider not updating hospice
payment rates by the payment update percentage. The 2.1 percent hospice
payment update percentage for FY 2017 is based on a 2.7 percent
inpatient hospital market basket update for FY 2017, reduced by a 0.3
percentage point productivity adjustment and by an
[[Page 52194]]
additional 0.3 percentage point. Payment rates since FY 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 years must
be the market basket percentage for that FY. Section 3401(g) of the
Affordable Care Act also mandates that, starting with FY 2013 (and in
subsequent years), the hospice payment update percentage will be
annually reduced by changes in economy-wide productivity as specified
in section 1886(b)(3)(B)(xi)(II) of the Act. In addition, section
3401(g) of the Affordable Care Act mandates that in FY 2013 through FY
2019, the hospice payment update percentage will be reduced by an
additional 0.3 percentage point (although for FY 2014 to FY 2019, the
potential 0.3 percentage point reduction is subject to suspension under
conditions specified in section 1814(i)(1)(C)(v) of the Act).
We considered not adopting a hospice wage index standardization
factor. However, as discussed in section III.C.1 of this final rule, we
believe that adopting a hospice wage index standardization factor would
provide a safeguard to the Medicare program, as well as to hospices,
because it will mitigate changes in overall hospice expenditures due to
annual fluctuations in the hospital wage data from year-to-year by
ensuring that hospice wage index updates and revisions are implemented
in a budget neutral manner. We estimate that if the hospice wage index
standardization factor is not finalized, total payments in a given year
would increase or decrease by as much as 0.3 percent or $50 million.
6. Accounting Statement
As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Table 20, we have
prepared an accounting statement showing the classification of the
expenditures associated with the provisions of this final rule. Table
20 provides our best estimate of the possible changes in Medicare
payments under the hospice benefit as a result of the policies in this
final rule. This estimate is based on the data for 4,177 hospices in
our impact analysis file, which was constructed using FY 2015 claims
available as of March 31, 2016. All expenditures are classified as
transfers to hospices.
Table 20--Accounting Statement: Classification of Estimated Transfers,
From FY 2016 to FY 2017
[in $Millions]
------------------------------------------------------------------------
Category Transfers
------------------------------------------------------------------------
FY 2017 Hospice Wage Index and Payment Rate Update
------------------------------------------------------------------------
Annualized Monetized Transfers.......... $350 *
From Whom to Whom? Federal Government to Medicare
Hospices.
------------------------------------------------------------------------
* The net increase of $350 million in transfer payments is a result of
the 2.1 percent hospice payment update percentage compared to payments
in FY 2016.
7. Conclusion
We estimate that aggregate payments to hospices in FY 2017 would
increase by $350 million, or 2.1 percent, compared to payments in FY
2016. We estimate that in FY 2017, hospices in urban and rural areas
would experience, on average, a 2.1 percent and a 2.0 percent increase,
respectively, in estimated payments compared to FY 2016. Hospices
providing services in the urban Pacific and rural Pacific regions would
experience the largest estimated increases in payments of 2.7 percent
and 2.8 percent, respectively. Hospices serving patients in rural areas
in the West North Central region would experience the lowest estimated
increase of 1.1 percent in FY 2017 payments.
B. Regulatory Flexibility Act Analysis
The RFA requires agencies to analyze options for regulatory relief
of small businesses if a rule has a significant impact on a substantial
number of small entities. The great majority of hospitals and most
other health care providers and suppliers are small entities by meeting
the Small Business Administration (SBA) definition of a small business
(in the service sector, having revenues of less than $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 they reach a
threshold of 3 to 5 percent or more of total revenue or total costs.
The effect of the final FY 2017 hospice payment update percentage
results in an overall increase in estimated hospice payments of 2.1
percent, or $350 million. Therefore, the Secretary has determined that
this final rule will not create a significant economic impact on a
substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a metropolitan
statistical area and has fewer than 100 beds. This final rule only
affects hospices. Therefore, the Secretary has determined that this
final rule will not have a significant impact on the operations of a
substantial number of small rural hospitals.
C. Unfunded Mandates Reform Act Analysis
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2016, that
threshold is approximately $146 million. This final rule is not
anticipated to have an effect on State, local, or tribal governments,
in the aggregate, or on the private sector of $146 million or more.
VI. Federalism Analysis
Executive Order 13132, Federalism (August 4, 1999) requires an
agency to provide federalism summary impact statement when it
promulgates a proposed rule (and subsequent final rule) that has
federalism implications and which imposes substantial direct
requirement costs on State and local governments which are not required
by statute. We have reviewed this final rule under these criteria of
Executive Order 13132, and have determined that it will not impose
substantial direct costs on state or local governments.
Dated: July 18, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Dated: July 25, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-18221 Filed 7-29-16; 4:15 pm]
BILLING CODE 4120-01-P