[Federal Register Volume 83, Number 151 (Monday, August 6, 2018)]
[Rules and Regulations]
[Pages 38622-38655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16539]



[[Page 38621]]

Vol. 83

Monday,

No. 151

August 6, 2018

Part V





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Part 418





Medicare Program; FY 2019 Hospice Wage Index and Payment Rate Update 
and Hospice Quality Reporting Requirements; Final Rule

  Federal Register / Vol. 83 , No. 151 / Monday, August 6, 2018 / Rules 
and Regulations  

[[Page 38622]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 418

[CMS-1692-F]
RIN 0938-AT26


Medicare Program; FY 2019 Hospice Wage Index and Payment Rate 
Update and Hospice Quality Reporting Requirements

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

ACTION: Final rule.

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SUMMARY: This final rule updates the hospice wage index, payment rates, 
and cap amount for fiscal year (FY) 2019. The rule also makes 
conforming regulations text changes to recognize physician assistants 
as designated hospice attending physicians effective January 1, 2019. 
Finally, the rule includes changes to the Hospice Quality Reporting 
Program.

DATES: These regulations are effective on October 1, 2018.

FOR FURTHER INFORMATION CONTACT: 
    Debra Dean-Whittaker, (410) 786-0848 for questions regarding the 
CAHPS[reg] Hospice Survey.
    Cindy Massuda, (410) 786-0652 for questions regarding the hospice 
quality reporting program.
    For general questions about hospice payment policy, send your 
inquiry via email to: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose

    This final rule updates the hospice payment rates for fiscal year 
(FY) 2019, as required under section 1814(i) of the Social Security Act 
(the Act). This rule also revises the hospice regulations as a result 
of section 51006 of the Bipartisan Budget Act of 2018, which amended 
section 1861(dd)(3)(B) of the Act such that, effective January 1, 2019, 
physician assistants (PAs) will be recognized as designated hospice 
attending physicians in addition to physicians and nurse practitioners. 
Finally, this rule includes changes to the hospice quality reporting 
program (HQRP), consistent with the requirements of section 1814(i)(5) 
of the Act. In accordance with section 1814(i)(5)(A) of the Act, 
hospices that fail to meet quality reporting requirements receive a 2 
percentage point reduction to their payments.

B. Summary of the Major Provisions

    Section III.B.1 of this rule updates the hospice wage index with 
updated wage data and makes the application of the updated wage data 
budget neutral for all four levels of hospice care. In section III.B.2 
of this final rule, we discuss the FY 2019 hospice payment update 
percentage of 1.8 percent. Sections III.B.3 and III.B.4 of this final 
rule update the hospice payment rates and hospice cap amount for FY 
2019 by the hospice payment update percentage discussed in section 
III.B.2 of this final rule. We also include regulations text changes in 
section III.C and section III.D pertaining to the definition of 
``attending physician'' and ``cap period.''
    Finally, in section III.E of this rule, we discuss updates to the 
HQRP, including: Data review and correction timeframes for data 
submitted using the HIS; extension of the Consumer Assessment of 
Healthcare Providers and Systems (CAHPS[reg]) Hospice Survey 
participation requirements, exemption criteria and public reporting 
policies to future years; procedures to announce quality measure 
readiness for public reporting and public reporting timelines; removal 
of routine public reporting of the 7 HIS measures; and public display 
of public use file data on the Hospice Compare website.

C. Summary of Impacts

    The overall economic impact of this final rule is estimated to be 
$340 million in increased payments to hospices during FY 2019.

D. Improving Patient Outcomes and Reducing Burden Through Meaningful 
Measures

    Regulatory reform and reducing regulatory burden are high 
priorities for CMS. To reduce the regulatory burden on the healthcare 
industry, lower health care costs, and enhance patient care, in October 
2017, we launched the Meaningful Measures Initiative.\1\ This 
initiative is one component of our agency-wide Patients Over Paperwork 
Initiative,\2\ which is aimed at evaluating and streamlining 
regulations with a goal to reduce unnecessary cost and burden, increase 
efficiencies, and improve beneficiary experience. The Meaningful 
Measures Initiative is aimed at identifying the highest priority areas 
for quality measurement and quality improvement in order to assess the 
core quality of care issues that are most vital to advancing our work 
to improve patient outcomes. The Meaningful Measures Initiative 
represents a new approach to quality measures that fosters operational 
efficiencies, and it will reduce costs, including collection and 
reporting burden, while producing quality measurement that is more 
focused on meaningful outcomes.
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    \1\ Meaningful Measures web page: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
    \2\ See Remarks by Administrator Seema Verma at the Health Care 
Payment Learning and Action Network (LAN) Fall Summit, as prepared 
for delivery on October 30, 2017: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.
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    The Meaningful Measures Framework has the following objectives:
     Address high-impact measure areas that safeguard public 
health;
     Patient-centered and meaningful to patients;
     Outcome-based where possible;
     Fulfill each program's statutory requirements;
     Minimize the level of burden for health care providers 
(for example, through a preference for EHR-based measures where 
possible, such as electronic clinical quality measures \3\);
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    \3\ See section VIII.A.8.c. of the preamble of this final rule 
where we solicited comments on the potential future development and 
adoption of eCQMs.
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     Significant opportunity for improvement;
     Address measure needs for population based payment through 
alternative payment models; and
     Align across programs and/or with other payers.
    In order to achieve these objectives, we have identified 19 
Meaningful Measures areas and mapped them to six overarching quality 
priorities as shown in the Table 1 below.

[[Page 38623]]



                      Table 1--Meaningful Measures
------------------------------------------------------------------------
            Quality priority                 Meaningful measure area
------------------------------------------------------------------------
Making Care Safer by Reducing Harm       Healthcare-Associated
 Caused in the Delivery of Care.          Infections.
                                         Preventable Healthcare Harm.
Strengthen Person and Family Engagement  Care is Personalized and
 as Partners in Their Care.               Aligned with Patient's Goals.
                                         End of Life Care according to
                                          Preferences.
                                         Patient's Experience of Care.
                                         Patient Reported Functional
                                          Outcomes.
Promote Effective Communication and      Medication Management.
 Coordination of Care.
                                         Admissions and Readmissions to
                                          Hospitals.
                                         Transfer of Health Information
                                          and Interoperability.
Promote Effective Prevention and         Preventive Care.
 Treatment of Chronic Disease.
                                         Management of Chronic
                                          Conditions.
                                         Prevention, Treatment, and
                                          Management of Mental Health.
                                         Prevention and Treatment of
                                          Opioid and Substance Use
                                          Disorders.
                                         Risk Adjusted Mortality.
Work with Communities to Promote Best    Equity of Care.
 Practices of Healthy Living.
                                         Community Engagement.
Make Care Affordable...................  Appropriate Use of Healthcare.
                                         Patient-focused Episode of
                                          Care.
                                         Risk Adjusted Total Cost of
                                          Care.
------------------------------------------------------------------------

    By including Meaningful Measures in our programs, we believe that 
we can also address the following cross-cutting measure criteria:
     Eliminating disparities;
     Tracking measurable outcomes and impact;
     Safeguarding public health;
     Achieving cost savings;
     Improving access for rural communities; and
     Reducing burden.
    We believe that the Meaningful Measures Initiative will improve 
outcomes for patients, their families, and health care providers while 
reducing burden and costs for clinicians and providers as well as 
promoting operational efficiencies.
    We received numerous supportive comments from stakeholders 
regarding the Meaningful Measures Initiative and the impact of its 
implementation in CMS' quality programs. Many of these comments 
pertained to specific program proposals, and are discussed in the 
appropriate program-specific sections of this final rule. Commenters 
also provided insights and recommendations for the ongoing development 
of the Meaningful Measures Initiative. We look forward to continuing to 
work with stakeholders to refine and further implement the Meaningful 
Measures Initiative, and will take commenters' insights and 
recommendations into account moving forward.

E. Advancing Health Information Exchange

    The Department of Health and Human Services (HHS) has a number of 
initiatives designed to encourage and support the adoption of 
interoperable health information technology and to promote nationwide 
health information exchange to improve health care. The Office of the 
National Coordinator for Health Information Technology (ONC) and CMS 
work collaboratively to advance interoperability across settings of 
care.
    The Improving Medicare Post-Acute Care Transformation Act of 2014 
(Pub. L. 113 185) (IMPACT Act) requires assessment data to be 
standardized and interoperable to allow for exchange of the data among 
post-acute providers and other providers. To further progress toward 
the goal of interoperability, we are developing a Data Element Library 
to serve as a publically available centralized, authoritative resource 
for standardized data elements and their associated mappings to health 
IT standards. These interoperable data elements can reduce provider 
burden by allowing the use and reuse of healthcare data, support 
provider exchange of electronic health information for care 
coordination, person-centered care, and support real-time, data driven, 
clinical decision making. Once available, standards in the Data Element 
Library can be referenced on the CMS website and in the ONC 
Interoperability Standards Advisory (ISA).
    The 2018 Interoperability Standards Advisory (ISA) is available at: 
https://www.healthit.gov/standards-advisory.
    Most recently, the 21st Century Cures Act (Pub. L. 114-255), 
enacted in 2016, requires HHS to take new steps to enable the 
electronic sharing of health information, ensuring interoperability for 
providers and settings across the care continuum. Specifically, the 
Congress directed ONC to ``develop or support a trusted exchange 
framework, including a common agreement among health information 
networks nationally.'' This framework (https://beta.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement) sets 
out a common set of principles for trusted exchange and minimum terms 
and conditions for trusted exchange in order to enable interoperability 
across disparate health information networks. In another important 
provision, the Congress established new authority for HHS to discourage 
``information blocking'', defined as practices likely to interfere 
with, prevent, or materially discourage access, exchange, or use of 
electronic health information. We suggested that hospice providers 
learn more about these important developments and how they are likely 
to affect hospices.

II. Background

A. Hospice Care

    Hospice care is a comprehensive, holistic approach to treatment 
that recognizes that the impending death of an individual, upon his or 
her choice, warrants a change in the focus from curative care to 
palliative care for relief of pain and for symptom management. Medicare 
regulations define ``palliative care'' as patient and family-centered 
care that optimizes quality of life by anticipating, preventing, and 
treating suffering. Palliative care throughout the continuum of illness 
involves addressing physical, intellectual, emotional, social, and 
spiritual needs and to facilitate patient autonomy, access to 
information, and choice (42 CFR 418.3). Palliative care is at the core 
of hospice philosophy and care practices, and is a critical component 
of the Medicare hospice benefit.
    The goal of hospice care is to help terminally ill individuals 
continue life

[[Page 38624]]

with minimal disruption to normal activities while remaining primarily 
in the home environment. A hospice uses an interdisciplinary approach 
to deliver medical, nursing, social, psychological, emotional, and 
spiritual services through a collaboration of professionals and other 
caregivers, with the goal of making the beneficiary as physically and 
emotionally comfortable as possible. Hospice is compassionate 
beneficiary and family/caregiver-centered care for those who are 
terminally ill.
    As referenced in our regulations at Sec.  418.22(b)(1), to be 
eligible for Medicare hospice services, the patient's attending 
physician (if any) and the hospice medical director must certify that 
the individual is ``terminally ill,'' as defined in section 
1861(dd)(3)(A) of the Act and our regulations at Sec.  418.3; that is, 
the individual's prognosis is for a life expectancy of 6 months or less 
if the terminal illness runs its normal course. The regulations at 
Sec.  418.22(b)(3) require that the certification and recertification 
forms include a brief narrative explanation of the clinical findings 
that support a life expectancy of 6 months or less.
    Under the Medicare hospice benefit, the election of hospice care is 
a patient choice and once a terminally ill patient elects to receive 
hospice care, a hospice interdisciplinary group is essential in the 
seamless provision of services. These hospice services are provided 
primarily in the individual's home. The hospice interdisciplinary group 
works with the beneficiary, family, and caregivers to develop a 
coordinated, comprehensive care plan; reduce unnecessary diagnostics or 
ineffective therapies; and maintain ongoing communication with 
individuals and their families about changes in their condition. The 
beneficiary's care plan will shift over time to meet the changing needs 
of the individual, family, and caregiver(s) as the individual 
approaches the end of life.
    While the goal of hospice care is to allow the beneficiary to 
remain in his or her home, circumstances during the end of life may 
necessitate short-term inpatient admission to a hospital, skilled 
nursing facility (SNF), or hospice facility for necessary pain control 
or acute or chronic symptom management that cannot be managed in any 
other setting. These acute hospice care services ensure that any new or 
worsening symptoms are intensively addressed so that the beneficiary 
can return to his or her home. Limited, short-term, intermittent, 
inpatient respite care (IRC) is also available because of the absence 
or need for relief of the family or other caregivers. Additionally, an 
individual can receive continuous home care (CHC) during a period of 
crisis in which an individual requires continuous care to achieve 
palliation or management of acute medical symptoms so that the 
individual can remain at home. Continuous home care may be covered for 
as much as 24 hours a day, and these periods must be predominantly 
nursing care, in accordance with 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. Additionally, they 
must 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/ocr/civilrights.

B. Services Covered by the Medicare Hospice Benefit

    Coverage under the Medicare Hospice benefit requires that hospice 
services must be reasonable and necessary for the palliation and 
management of the terminal illness and related conditions. Section 
1861(dd)(1) of the Act establishes the services that are to be rendered 
by a Medicare-certified hospice program. These covered services 
include: Nursing care; physical therapy; occupational therapy; speech-
language pathology therapy; medical social services; home health aide 
services (now called hospice aide services); physician services; 
homemaker services; medical supplies (including drugs and biologicals); 
medical appliances; counseling services (including dietary counseling); 
short-term inpatient care in a hospital, nursing facility, or hospice 
inpatient facility (including both respite care and procedures 
necessary for pain control and acute or chronic symptom management); 
continuous home care during periods of crisis, and only as necessary to 
maintain the terminally ill individual at home; and any other item or 
service which is specified in the plan of care and for which payment 
may otherwise be made under Medicare, in accordance with Title XVIII of 
the Act.
    Section 1814(a)(7)(B) of the Act requires that a written plan for 
providing hospice care to a beneficiary who is a hospice patient be 
established before care is provided by, or under arrangements made by, 
that hospice program; and that the written plan be periodically 
reviewed by the beneficiary's attending physician (if any), the hospice 
medical director, and an interdisciplinary group (described in section 
1861(dd)(2)(B) of the Act). The services offered under the Medicare 
hospice benefit must be available to beneficiaries as needed, 24 hours 
a day, 7 days a week (section 1861(dd)(2)(A)(i) of the Act).
    Upon the implementation of the hospice benefit, the Congress also 
expected hospices to continue to use volunteer services, though these 
services are not reimbursed by Medicare (see section 1861(dd)(2)(E) of 
the Act). As stated in the FY 1983 Hospice Wage Index and Rate Update 
proposed rule (48 FR 38149), the hospice interdisciplinary group should 
comprise paid hospice employees as well as hospice volunteers, and that 
``the hospice benefit and the resulting Medicare reimbursement is not 
intended to diminish the voluntary spirit of hospices.'' This 
expectation supports the hospice philosophy of community based, 
holistic, comprehensive, and compassionate end-of-life care.

C. Medicare Payment for Hospice Care

    Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of 
the Act, and our regulations in 42 CFR part 418, establish eligibility 
requirements, payment standards and procedures; define covered 
services; and delineate the conditions a hospice must meet to be 
approved for participation in the Medicare program. Part 418, subpart 
G, provides for a per diem payment in one of four prospectively-
determined rate categories of hospice care (routine home care (RHC), 
CHC, IRC, and general inpatient care (GIP)), based on each day a 
qualified Medicare beneficiary is under hospice care (once the 
individual has elected). This per diem payment is to include all of the 
hospice services and items needed to manage the beneficiary's care, as 
required by section 1861(dd)(1) of the Act. There has been little 
change in the hospice payment structure since the benefit's inception. 
The per diem rate based on level of care was established in 1983, and 
this payment structure remains today with some adjustments, as noted 
below.
1. Omnibus Budget Reconciliation Act of 1989
    Section 6005(a) of the Omnibus Budget Reconciliation Act of 1989 
(Pub.

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L. 101-239) amended section 1814(i)(1)(C) of the Act and provided 
changes in the methodology concerning updating the daily payment rates 
based on the hospital market basket percentage increase applied to the 
payment rates in effect during the previous federal fiscal year.
2. Balanced Budget Act of 1997
    Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 
105-33) established that updates to the hospice payment rates beginning 
FY 2002 and subsequent FYs be the hospital market basket percentage 
increase for the FY.
3. FY 1998 Hospice Wage Index Final Rule
    The FY 1998 Hospice Wage Index final rule (62 FR 42860), 
implemented a new methodology for calculating the hospice wage index 
and instituted an annual Budget Neutrality Adjustment Factor (BNAF) so 
aggregate Medicare payments to hospices would remain budget neutral to 
payments calculated using the 1983 wage index.
4. FY 2010 Hospice Wage Index Final Rule
    The FY 2010 Hospice Wage Index and Rate Update final rule (74 FR 
39384) instituted an incremental 7-year phase-out of the BNAF beginning 
in FY 2010 through FY 2016. The BNAF phase-out reduced the amount of 
the BNAF increase applied to the hospice wage index value, but was not 
a reduction in the hospice wage index value itself or in the hospice 
payment rates.
5. The Affordable Care Act
    Starting with FY 2013 (and in subsequent FYs), the market basket 
percentage update under the hospice payment system referenced in 
sections 1814(i)(1)(C)(ii)(VII) and 1814(i)(1)(C)(iii) of the Act is 
subject to annual reductions related to changes in economy-wide 
productivity, as specified in section 1814(i)(1)(C)(iv) of the Act. In 
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 Patient Protection and Affordable Care 
Act (PPACA) (Pub. L. 111-148), 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 that fail to report 
quality data will have their market basket percentage increase reduced 
by 2 percentage points.
    Section 1814(a)(7)(D)(i) of the Act, as added by section 3132(b)(2) 
of the PPACA, 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 FY 2011 Hospice Wage 
Index final rule (75 FR 70435) that the 180th-day recertification and 
subsequent recertifications would correspond to the beneficiary's third 
or subsequent benefit periods. Further, section 1814(i)(6) of the Act, 
as added by section 3132(a)(1)(B) of the PPACA, 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 PPACA could capture 
accurate resource utilization, which could be collected on claims, cost 
reports, and possibly other mechanisms, as the Secretary determined to 
be appropriate. The data collected could be used to revise the 
methodology for determining the payment rates for RHC and other 
services included in hospice care, no earlier than October 1, 2013, as 
described in section 1814(i)(6)(D) of the Act. In addition, we were 
required to consult with hospice programs and the Medicare Payment 
Advisory Commission (MedPAC) regarding additional data collection and 
payment revision options.
6. FY 2012 Hospice Wage Index Final Rule
    In the FY 2012 Hospice Wage Index final rule (76 FR 47308 through 
47314) we announced that beginning in 2012, the hospice aggregate cap 
would be calculated using the patient-by-patient proportional 
methodology, within certain limits. We allowed existing hospices the 
option of having their cap calculated through the original streamlined 
methodology, also within certain limits. As of FY 2012, new hospices 
have their cap determinations calculated using the patient-by-patient 
proportional methodology. If a hospice's total Medicare payments for 
the cap year exceed the hospice aggregate cap, then the hospice must 
repay the excess back to Medicare.
7. FY 2015 Hospice Wage Index and Payment Rate Update Final Rule
    The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 
50452) finalized a requirement that 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 within 5 calendar days after the effective date of the 
discharge/revocation (unless the hospice has already filed a final 
claim) through the submission of a final claim or a Notice of 
Termination or Revocation (NOTR).
    The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 
50479) also finalized a requirement that the election form include the 
beneficiary's choice of attending physician and that the beneficiary 
provide the hospice with a signed document when he or she chooses to 
change attending physicians.
    Hospice providers are required to begin using a Hospice Experience 
of Care Survey for informal caregivers of hospice patients as of 2015. 
The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50496) 
provided background, eligibility criteria, survey respondents, and 
implementation of the Hospice Experience of Care Survey for informal 
caregivers, that hospices are required to use as of 2015.
    Finally, the FY 2015 Hospice Wage Index and Rate Update final rule 
required providers to complete their aggregate cap determination not 
sooner than 3 months after the end of the cap year, and not later than 
5 months after, and remit any overpayments. Those hospices that fail to 
timely submit their aggregate cap determinations will have their 
payments suspended until the determination is completed and received by 
the Medicare contractor (79 FR 50503).
8. IMPACT Act of 2014
    The Improving Medicare Post-Acute Care Transformation Act of 2014 
(IMPACT Act) (Pub. L. 113-185) became law on October 6, 2014. Section 
3(a) of the IMPACT Act mandated that all Medicare certified hospices be 
surveyed every 3 years beginning April 6, 2015 and ending September 30, 
2025. In

[[Page 38626]]

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 Wage Index and Rate Update final rule (80 FR 
47172), we created two different payment rates for RHC that resulted in 
a higher base payment rate for the first 60 days of hospice care and a 
reduced base payment rate for subsequent days of hospice care. We also 
created a Service Intensity Add-on (SIA) payment payable for services 
during the last 7 days of the beneficiary's life, equal to the CHC 
hourly payment rate multiplied by the amount of direct patient care 
provided by a registered nurse (RN) or social worker that occurs during 
the last 7 days (80 FR 47177).
    In addition to the hospice payment reform changes discussed, the FY 
2016 Hospice Wage Index and Rate Update final rule (80 FR 47186) 
implemented changes mandated by the IMPACT Act, in which the cap amount 
for accounting years that end after September 30, 2016 and before 
October 1, 2025 is updated by the hospice payment update percentage 
rather than using the CPI-U. This was applied to the 2016 cap year, 
starting on November 1, 2015 and ending on October 31, 2016. In 
addition, we finalized a provision to align the cap accounting year for 
both the inpatient cap and the hospice aggregate cap with the fiscal 
year for FY 2017 and thereafter. Finally, the FY 2016 Hospice Wage 
Index and Rate Update final rule (80 FR 47144) clarified that hospices 
must report all diagnoses of the beneficiary on the hospice claim as a 
part of the ongoing data collection efforts for possible future hospice 
payment refinements.
10. FY 2017 Hospice Wage Index and Payment Rate Update Final Rule
    In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 
52160), we finalized several new policies and requirements related to 
the HQRP. First, we codified our policy that if the National Quality 
Forum (NQF) made non-substantive changes to specifications for HQRP 
measures as part of the NQF's re-endorsement process, we would continue 
to utilize the measure in its new endorsed status, without going 
through new notice-and-comment rulemaking. We would continue to use 
rulemaking to adopt substantive updates made by the NQF to the endorsed 
measures we have adopted for the HQRP; determinations about what 
constitutes a substantive versus non-substantive change would be made 
on a measure-by-measure basis. Second, we finalized two new quality 
measures for the HQRP for the FY 2019 payment determination and 
subsequent years: Hospice Visits when Death is Imminent Measure Pair 
and Hospice and Palliative Care Composite Process Measure-Comprehensive 
Assessment at Admission (81 FR 52173). The data collection mechanism 
for both of these measures is the HIS, and the measures were effective 
April 1, 2017. Regarding the CAHPS[supreg] Hospice Survey, we finalized 
a policy that hospices that receive their CMS Certification Number 
(CCN) after January 1, 2017 for the FY 2019 Annual Payment Update (APU) 
and January 1, 2018 for the FY 2020 APU will be exempted from the 
Hospice Consumer Assessment of Healthcare Providers and Systems 
(CAHPS[reg]) requirements due to newness (81 FR 52182). The exemption 
is determined by CMS and is for 1 year only.

D. Trends in Medicare Hospice Utilization

    Since the implementation of the hospice benefit in 1983, 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 
1.5 million in FY 2017. Similarly, Medicare hospice expenditures have 
risen from $2.8 billion in FY 2000 to approximately $17.7 billion in FY 
2017. Our Office of the Actuary (OACT) projects that hospice 
expenditures are expected to continue to increase, by approximately 8 
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.
    There have also been changes in the diagnosis patterns among 
Medicare hospice enrollees. While in 2002, lung cancer was the top 
principal diagnosis, neurologically based diagnoses have topped the 
list for the past 5 years. Additionally, 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; however, effective October 
1, 2014, these diagnoses are no longer permitted as principal diagnosis 
codes on hospice claims. As a result of this, the most common hospice 
claims-reported diagnoses have changed from primarily cancer diagnoses 
to neurological and organ-based failure diagnoses. The top 20 most 
frequently hospice claims-reported diagnoses for FY 2017 are in Table 2 
below.

      Table 2--The Top Twenty Principal Hospice Diagnoses, FY 2017
------------------------------------------------------------------------
                        ICD-10/reported
         Rank              principal           Count        Percentage
                           diagnosis
------------------------------------------------------------------------
1....................  G30.9 Alzheimer's         155,066              10
                        disease,
                        unspecified.
2....................  J44.9 Chronic              77,758               5
                        obstructive
                        pulmonary
                        disease.
3....................  I50.9 Heart                69,216               4
                        failure,
                        unspecified.
4....................  G31.1 Senile               66,309               4
                        degeneration of
                        brain, not
                        elsewhere
                        classified.
5....................  C34.90 Malignant           53,137               3
                        Neoplasm Of Unsp
                        Part Of Unsp
                        Bronchus Or Lung.
6....................  G20 Parkinson's            40,186               3
                        disease.
7....................  G30.1 Alzheimer's          38,710               2
                        disease with
                        late onset.
8....................  I25.10                     34,761               2
                        Atherosclerotic
                        heart disease of
                        native coronary
                        art without
                        angina pectoris.
9....................  J44.1 Chronic              33,547               2
                        obstructive
                        pulmonary
                        disease with
                        (acute)
                        exacerbation.
10...................  I67.2 Cerebral             30,146               2
                        atherosclerosis.
11...................  C61 Malignant              25,215               2
                        neoplasm of
                        prostate.
12...................  I63.9 Cerebral             22,825               1
                        infarction,
                        unspecified.
13...................  N18.6 End stage            21,549               1
                        renal disease.
14...................  C18.9 Malignant            21,543               1
                        neoplasm of
                        colon,
                        unspecified.
15...................  C25.9 Malignant            20,851               1
                        neoplasm of
                        pancreas,
                        unspecified.

[[Page 38627]]

 
16...................  I51.9 Heart                18,794               1
                        disease,
                        unspecified.
17...................  I11.0                      18,345               1
                        Hypertensive
                        heart disease
                        with heart
                        failure.
18...................  I67.9                      18,234               1
                        Cerebrovascular
                        disease,
                        unspecified.
19...................  I13.0                      15,632               1
                        Hypertensive
                        heart and
                        chronic kidney
                        disease with
                        heart failure
                        and stage 1
                        through stage 4
                        chronic kidney
                        disease, or
                        unspecified
                        chronic kidney
                        disease.
20...................  A41.9 Sepsis,              14,012               1
                        unspecified
                        organism.
------------------------------------------------------------------------
Note(s): The frequencies shown represent beneficiaries that had a least
  one claim with the specific ICD-10 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 2017 hospice claims data from the CCW, accessed and merged
  with ICD-10 codes on January 10, 2018.

    In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 
47201), we clarified that hospices will report all diagnoses identified 
in the initial and comprehensive assessments on hospice claims, whether 
related or unrelated to the terminal prognosis of the individual, 
effective October 1, 2015. Analysis of FY 2017 hospice claims show that 
100 percent of hospices reported more than one diagnosis, 89 percent 
submitted at least two diagnoses, and 81 percent included at least 
three diagnoses.

III. Provisions of the Final Rule

    On May 8, 2018, we published the FY 2019 Hospice Wage Index and 
Payment Rate Update and Hospice Quality Reporting Requirements proposed 
rule in the Federal Register (83 FR 20934 through 20970) and provided a 
60-day comment period. In that proposed rule, we proposed to update the 
hospice wage index, payment rates, and cap amount for fiscal year (FY) 
2019. In addition, we proposed regulations text changes to recognize 
physician assistants as designated hospice attending physicians 
effective January 1, 2019. Finally, we proposed changes to the Hospice 
Quality Reporting Program. We received 56 public comments on the 
proposed rule, including comments from hospice agencies, national 
provider associations, patient organizations, nurses, and advocacy 
groups.
    Below 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 in the FY 2019 Hospice Wage Index and 
Payment Rate Update and Hospice Quality Reporting Requirements final 
rule.

A. Monitoring for Potential Impacts--Affordable Care Act Hospice Reform

    In the FY 2019 Hospice Wage Index and Payment Rate Update proposed 
rule (83 FR 20934), we provided a summary of analysis conducted on 
hospice length of stay, live discharge rates, skilled visits in the 
last days of life, and non-hospice spending. Additionally, we discussed 
initial analyses of data from recently revised cost reports. 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 comments on the hospice monitoring analysis and CMS's 
plans for future monitoring efforts with regard to hospice payment 
reform outlined in the proposed rule. The comments and our responses 
are described below:
    Comment: Commenters expressed continued support for our plans to 
monitor the impact of hospice payment reform and suggested the use of 
monitoring results in order to better target program integrity efforts. 
One commenter suggested that providers would benefit from CMS providing 
data assessing the impact of the payment changes that occurred in early 
2016 and the degree to which they are on track with the re-
distributional impact that CMS anticipated as a part of its modeling. A 
commenter suggested that CMS focus on short lengths of stays in hospice 
rather than long length of stays as long length of stays, which could 
be an indicator of problematic behavior, noting that the median length 
of stay has remained constant at 18 days, and the commenter suggested 
that the focus of analysis should be on beneficiary access to hospice 
services. One commenter recommended that CMS revisit and clarify what 
should be covered under the hospice per diem, noting that clarification 
would enhance care for patients and families, allow for easier 
comparison of programs, and allow for increased program integrity 
efforts based on this data point. Finally, a few commenters noted 
concerns with increased scrutiny of claims for GIP care and the 
variability of costs for GIP care depending on whether the hospice 
provides the care in a facility or contracts with another entity. 
Commenters suggested that CMS provide further education and 
clarification of acceptable GIP utilization for hospice providers as a 
means of encouraging them to provide the most appropriate level of care 
for the patient.
    Response: We appreciate the comments provided regarding the ongoing 
analysis presented, and we plan continue to monitor hospice trends and 
vulnerabilities within the hospice benefit, while also investigating 
the means by which we can educate the provider community regarding the 
hospice benefit and appropriate billing practices. We will also 
consider these suggestions for future monitoring efforts, program 
integrity, and for potential policy or payment refinements. 
Additionally, we refer readers to sections 1812(d), 1813(a)(4), 
1814(a)(7), 1814(i), and 1861(dd) of the Act, our regulations in the 
Code of Federal Regulations (CFR) 42 CFR part 418, which 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 and the CMS 
Hospice Center web page for more information (https://www.cms.gov/Center/Provider-Type/Hospice-Center.html).
    Comment: Several commenters recommended that CMS move to implement 
additional Level 1 edits for the hospice cost reports in order to 
address existing gaps in data collection to meet minimum standards of 
accuracy. In addition, many commenters suggested that CMS should wait 
until the latest cost report changes (including imposition of 
additional Level 1 edits) are reflected in the data to ensure greater 
accuracy of data inputs.
    Response: We appreciate support of the Level 1 edits to further 
address accuracy in cost reporting. As several commenters noted, on 
April 13, 2018, CMS issued Transmittal 3 revising the Medicare Provider 
Reimbursement

[[Page 38628]]

Manual--Part 2, Provider Cost Reporting Forms and Instructions, Chapter 
43, Form CMS-1984-14. Transmittal 3 made several changes to the Hospice 
Cost Report, including the imposition of Level 1 and Level 2 edits 
(https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3P243.pdf). These changes are effective for cost 
reporting periods ending on or after December 31, 2017. We will 
continue to analyze Medicare hospice cost report data as it becomes 
available in determining whether additional hospice payment reform 
changes are needed to better align hospice payments with costs.

B. FY 2019 Hospice Wage Index and Rate Update

1. FY 2019 Hospice Wage Index
    The hospice wage index is used to adjust payment rates for hospice 
agencies under the Medicare program to reflect local differences in 
area wage levels, based on the location where services are furnished. 
The hospice wage index utilizes the wage adjustment factors used by the 
Secretary for purposes of section 1886(d)(3)(E) of the Act for hospital 
wage adjustments. Our regulations at Sec.  418.306(c) require each 
labor market to be established using the most current hospital wage 
data available, including any changes made by Office of Management and 
Budget (OMB) to the Metropolitan Statistical Areas (MSAs) definitions.
    We use the previous FY's hospital wage index data to calculate the 
hospice wage index values. For FY 2019, the hospice wage index will be 
based on the FY 2018 hospital pre-floor, pre-reclassified wage index. 
This means that the hospital wage data used for the hospice wage index 
are not adjusted to take into account any geographic reclassification 
of hospitals including those in accordance with section 1886(d)(8)(B) 
or 1886(d)(10) of the Act. The appropriate wage index value is applied 
to the labor portion of the payment rate based on the geographic area 
in which the beneficiary resides when receiving RHC or CHC. The 
appropriate wage index value is applied to the labor portion of the 
payment rate based on the geographic location of the facility for 
beneficiaries receiving GIP or IRC.
    In the FY 2006 Hospice Wage Index final rule (70 FR 45135), we 
adopted the policy that, for urban labor markets without a hospital 
from which hospital wage index data could be derived, all of the Core-
Based Statistical Areas (CBSAs) within the state would be used to 
calculate a statewide urban average pre-floor, pre-reclassified 
hospital wage index value to use as a reasonable proxy for these areas. 
For FY 2019, the only CBSA without a hospital from which hospital wage 
data can be derived is 25980, Hinesville-Fort Stewart, Georgia.
    In the FY 2008 Hospice Wage Index final rule (72 FR 50214), we 
adopted a policy for instances where there are rural areas without 
rural hospital wage data. In such instances, we use the average pre-
floor, pre-reclassified hospital wage index data from all contiguous 
CBSAs, to represent a reasonable proxy for the rural area. The term 
``contiguous'' means sharing a border (72 FR 50217). Currently, the 
only rural area without a hospital from which hospital wage data could 
be derived is Puerto Rico. However, for rural Puerto Rico, we would not 
apply this methodology due to the distinct economic circumstances that 
exist there (for example, due to the close proximity to one another of 
almost all of Puerto Rico's various urban and non-urban areas, this 
methodology would produce a wage index for rural Puerto Rico that is 
higher than that in half of its urban areas); instead, we would 
continue to use the most recent wage index previously available for 
that area. For FY 2019, we proposed to continue to use the most recent 
pre-floor, pre-reclassified hospital wage index value available for 
Puerto Rico, which is 0.4047, subsequently adjusted by the hospice 
floor.
    As described in the August 8, 1997 Hospice Wage Index final rule 
(62 FR 42860), the pre-floor and pre-reclassified hospital wage index 
is used as the raw wage index for the hospice benefit. These raw wage 
index values are subject to application of the hospice floor to compute 
the hospice wage index used to determine payments to hospices. Pre-
floor, pre-reclassified hospital wage index values below 0.8 are 
adjusted by a 15 percent increase subject to a maximum wage index value 
of 0.8. For example, if County A has a pre-floor, pre-reclassified 
hospital wage index value of 0.3994, we would multiply 0.3994 by 1.15, 
which equals 0.4593. Since 0.4593 is not greater than 0.8, then County 
A's hospice wage index would be 0.4593. In another example, if County B 
has a pre-floor, pre-reclassified hospital wage index value of 0.7440, 
we would multiply 0.7440 by 1.15 which equals 0.8556. Because 0.8556 is 
greater than 0.8, County B's hospice wage index would be 0.8.
    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. In the FY 2016 Hospice Wage Index and Rate Update final 
rule (80 FR 47178), we adopted the OMB's new area delineations using a 
1-year transition. In that final rule, we stated that beginning October 
1, 2016, the wage index for all hospice payments would be fully based 
on the new OMB delineations.
    On August 15, 2017, OMB issued bulletin No. 17-01, which is 
available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf. In this bulletin, OMB announced that one 
Micropolitan Statistical Area, Twin Falls, Idaho, now qualifies as a 
Metropolitan Statistical Area. The new CBSA (46300) comprises the 
principal city of Twin Falls, Idaho in Jerome County, Idaho and Twin 
Falls County, Idaho. The FY 2019 hospice wage index value for CBSA 
46300, Twin Falls, Idaho, will be 0.8000.
    The hospice wage index applicable for FY 2019 (October 1, 2018 
through September 30, 2019) is available on our website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/index.html.
    A summary of the comments we received regarding the wage index and 
our responses to those comments appear below:
    Comment: A commenter stated that in FY 2018, the wage index for 
Spokane, WA had increased, which helped increase wages for employees 
and reduced turnover. However, the commenter noted that in the FY 2019 
proposed rule, this increase is reversing. The commenter stated that 
using older wage index data, not allowing reclassification, and not 
accounting for outward migration speaks to the need for wage index 
reform for the hospice payment system. One commenter stated that in 
rural Kentucky and Indiana, the costs of providing hospice care exceed 
Medicare payments. The commenter further asserted that a lower 
reimbursement rate for rural areas when compared to urban areas is not 
sensible, given that urban areas have infrastructure that facilitates 
access to care. Another commenter expressed concern with the continued 
use of the pre-floor, pre-reclassified hospital wage index to adjust 
the hospice payment rates and stated that this causes continued 
volatility of the hospice wage index from one year to the next. The 
commenter stated that the volatility is often based on inaccurate or 
incomplete hospital cost report data.
    Response: The annual changes in the wage index reflect real 
variations in costs of providing care in various

[[Page 38629]]

geographic locations. We utilize efficient means to ensure and review 
the accuracy of the hospital cost report data and resulting wage index. 
The hospice wage index is derived from the pre-floor, pre-reclassified 
wage index, which is calculated based on cost report data from 
hospitals. All Inpatient Prospective Payment System (IPPS) hospitals 
must complete the wage index survey (Worksheet S-3, Parts II and III) 
as part of their Medicare cost reports. Cost reports will be rejected 
if Worksheet S-3 is not completed. In addition, our Medicare 
contractors perform desk reviews on all hospitals' Worksheet S-3 wage 
data, and we run edits on the wage data to further ensure the accuracy 
and validity of the wage data. Our review processes result in an 
accurate reflection of the applicable wages for the areas given. In 
addition, we finalized a hospice wage index standardization factor in 
FY 2017 to ensure overall budget neutrality when updating the hospice 
wage index with more recent hospital wage data. Applying a wage index 
standardization factor to hospice payments will eliminate the aggregate 
effect of annual variations in hospital wage data. Our policy of 
utilizing a hospice wage index standardization factor provides a 
safeguard to the Medicare program as well as to hospices because it 
will mitigate fluctuations in the wage index by ensuring that wage 
index updates and revisions are implemented in a budget neutral manner.
    We note that the current statute and regulations that govern the 
hospice payment system do not currently provide a mechanism for 
allowing hospices to seek geographic reclassification. The 
reclassification provision is found in section 1886(d)(10)(C)(i) of the 
Act, which states, ``The Board shall consider the application of any 
subsection (d) hospital requesting that the Secretary change the 
hospital's geographic classification . . . '' This provision is only 
applicable to hospitals as defined in section 1886(d) of the Act. In 
addition, we do not believe that using hospital reclassification data 
would be appropriate, as these data are specific to the requesting 
hospitals and they may or may not apply to a given hospice.
    Comment: One commenter expressed concern that the proposed FY 2019 
hospice wage index will be based on the OMB geographic area wage 
delineations. The commenter was particularly concerned with the New 
York City CBSA and the fact that the CBSA contains counties from New 
Jersey where labor costs are lower.
    Response: 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.
    Comment: One commenter expressed concern that hospices in 
Montgomery County, Maryland, which are included in CBSA 43524 (Silver 
Spring-Frederick-Rockville, MD), are reimbursed at a lower rate than 
hospices in the greater Washington DC area that are included in CBSA 
47894 (Washington-Arlington-Alexandria, DCVA-MD-WV). The commenters 
request that CMS reconsider CBSA 43524 (Silver Spring-Frederick-
Rockville, MD).
    Response: CBSA delineations are determined by the OMB. The OMB 
reviews its Metropolitan Area definitions preceding each decennial 
census to reflect recent population changes. The OMB's CBSA 
designations reflect the most recent available geographic 
classifications and were a reasonable and appropriate way to define 
geographic areas for purposes of wage index values. Ten years ago, in 
our FY 2006 Hospice Wage Index final rule (70 FR 45130), we finalized 
the adoption of the revised labor market area definitions as discussed 
in the OMB Bulletin No. 03-04 (June 6, 2003). In the December 27, 2000 
Federal Register (65 FR 82228 through 82238), OMB announced its new 
standards for defining metropolitan and micropolitan statistical areas. 
According to that notice, OMB defines a CBSA, beginning in 2003, as ``a 
geographic entity associated with at least one core of 10,000 or more 
population, plus adjacent territory that has a high degree of social 
and economic integration with the core as measured by commuting ties. 
The general concept of the CBSAs is that of an area containing a 
recognized population nucleus and adjacent communities that have a high 
degree of integration with that nucleus. The purpose of the standards 
is to provide nationally consistent definitions for collecting, 
tabulating, and publishing federal statistics for a set of geographic 
areas. CBSAs include adjacent counties that have a minimum of 25 
percent commuting to the central counties of the area. This is an 
increase over the minimum commuting threshold for outlying counties 
applied in the previous MSA definition of 15 percent. Based on the 
OMB's current delineations, Montgomery County (along with Frederick 
County, Maryland) belongs in a separate CBSA from the areas defined in 
the Washington-Arlington-Alexandria, DC-VA CBSA. Unlike IPPS, inpatient 
rehabilitation facility (IRF), and SNF, where each provider uses a 
single CBSA, hospice agencies may be reimbursed based on more than one 
wage index. Payments are based upon the location of the beneficiary for 
routine and continuous home care or the location of the agency for 
respite and general inpatient care. It is very likely that hospices in 
Montgomery County, Maryland provide RHC and CHC to patients in the 
``Washington-Arlington-Alexandria, DC-VA'' CBSA in addition to serving 
patients in the ``Baltimore-Columbia-Towson, Maryland'' CBSA.
    While CMS and other stakeholders have explored potential 
alternatives to the current CBSA-based labor market system (we refer 
readers to our website: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Reform.html), no consensus 
has been achieved regarding how best to implement a replacement system. 
As discussed in the FY 2005 IPPS final rule (69 FR 49027), ``While we 
recognize that MSAs are not designed specifically to define labor 
market areas, we believe they do represent a useful proxy for this 
purpose.'' We further believe that using the most current OMB 
delineations will increase the integrity of the hospice wage index by 
creating a more accurate representation of geographic variation in wage 
levels. We recognize that the OMB cautions that the delineations should 
not be used to develop and implement federal, state, and local 
nonstatistical programs and policies without full consideration of the 
effects of using these delineations for such purposes. As discussed in 
the OMB Bulletin No. 03-04 (June 6, 2003), The OMB stated that, ``In 
cases where there is no statutory requirement and an agency elects to 
use the Metropolitan, Micropolitan, or Combined Statistical Area 
definitions in nonstatistical programs, it is the sponsoring agency's 
responsibility to ensure that the definitions are appropriate for such 
use. When an agency is publishing for comment a proposed regulation 
that would use the definitions for a nonstatistical purpose, the agency 
should seek public comment on the proposed use.'' \4\ While we 
recognize that OMB's geographic area delineations are not designed 
specifically for use in nonstatistical programs or for program 
purposes, including the allocation of federal funds, we continue to 
believe that the

[[Page 38630]]

OMB's geographic area delineations represent a useful proxy for 
differentiating between labor markets and that the geographic area 
delineations are appropriate for use in determining Medicare hospice 
payments. In implementing the use of CBSAs for hospice payment purposes 
in our FY 2006 rule (70 FR 45130), we considered the effects of using 
these delineations. We have used CBSAs for determining hospice payments 
for 10 years (since FY 2006). In addition, other provider types, such 
as IPPS hospital, home health, SNF, IRF), and the ESRD program, have 
used CBSAs to define their labor market areas for the last decade.
---------------------------------------------------------------------------

    \4\ https://www.whitehouse.gov/wp-content/uploads/2017/11/bulletins_b03-04.pdf.
---------------------------------------------------------------------------

    Final Decision: After considering the comments received in response 
to the proposed rule and for the reasons discussed above, we are 
finalizing our proposal to use the pre-floor, pre-reclassified hospital 
inpatient wage index as the wage adjustment to the labor portion of the 
hospice rates. For FY 2019, the updated wage data are for hospital cost 
reporting periods beginning on or after October 1, 2013 and before 
October 1, 2014 (FY 2014 cost report data).
    The wage index applicable for FY 2019 is available on our website 
at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/index.html. The hospice wage index for FY 2019 will be 
effective October 1, 2018 through September 30, 2019.
2. FY 2019 Hospice Payment Update Percentage
    Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 
105-33) amended section 1814(i)(1)(C)(ii)(VI) of the Act to establish 
updates to hospice rates for FYs 1998 through 2002. Hospice rates were 
to be updated by a factor equal to the inpatient hospital market basket 
percentage increase set out under section 1886(b)(3)(B)(iii) of the 
Act, minus 1 percentage point. Payment rates for FYs since 2002 have 
been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, 
which states that the update to the payment rates for subsequent FYs 
must be the inpatient market basket percentage increase for that FY. 
The Act historically required us to use the inpatient hospital market 
basket as the basis for the hospice payment rate update.
    Section 3401(g) of the PPACA mandated that, starting with FY 2013 
(and in subsequent FYs), the hospice payment update percentage would be 
annually reduced by changes in economy-wide productivity as specified 
in section 1886(b)(3)(B)(xi)(II) of the Act. The statute defines the 
productivity adjustment to be equal to the 10-year moving average of 
changes in annual economy-wide private nonfarm business multifactor 
productivity (MFP). In addition to the MFP adjustment, section 3401(g) 
of the ACA also mandated that in FY 2013 through FY 2019, the hospice 
payment update percentage would 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 2019 is based on the 
inpatient hospital market basket update of 2.9 percent (based on IHS 
Global Inc.'s second-quarter 2018 forecast with historical data through 
the first-quarter 2018). Due to the requirements at sections 
1886(b)(3)(B)(xi)(II) and 1814(i)(1)(C)(v) of the Act, the inpatient 
hospital market basket update for FY 2019 of 2.9 percent must be 
reduced by a MFP adjustment as mandated by the PPACA (0.8 percentage 
point for FY 2019). The inpatient hospital market basket update for FY 
2019 is reduced further by 0.3 percentage point, as mandated by the 
PPACA. In effect, the hospice payment update percentage for FY 2019 is 
1.8 percent.
    Currently, the labor portion of the hospice payment rates is as 
follows: for RHC, 68.71 percent; for CHC, 68.71 percent; for General 
Inpatient Care, 64.01 percent; and for Respite Care, 54.13 percent. The 
non-labor portion is equal to 100 percent minus the labor portion for 
each level of care. Therefore, the non-labor portion of the payment 
rates is as follows: for RHC, 31.29 percent; for CHC, 31.29 percent; 
for General Inpatient Care, 35.99 percent; and for Respite Care, 45.87 
percent. Beginning with cost reporting periods starting on or after 
October 1, 2014, freestanding hospice providers are required to submit 
cost data using CMS Form 1984-14 (https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-1984-14.html). We are currently analyzing this data for possible use in 
updating the labor portion of the hospice payment rates. Any changes to 
the labor portions would be proposed in future rulemaking and would be 
subject to public comments.
    A summary of the comments we received regarding the payment update 
percentage 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: Several commenters stated that the FY 2019 payment update 
of 1.8 percent is inadequate. One commenter stated that the payment 
update is insufficient to sustainably cover the broad range of services 
and high-quality care that their members provide regardless of 
diagnosis, location and payment source. Another commenter suggested 
that the multifactor productivity (MFP) adjustment is not related to 
hospice care productivity, but instead, is a uniform adjustment factor 
that is being applied to all proposed prospective payment rate 
increases for 2019. The commenter suggests that CMS should identify and 
report specific productivity performances for each unique healthcare 
category. Another commenter expressed concern that the 1.8 percent 
increase would not cover the 2 percent decrease in reimbursement that 
would be imposed should sequestration be required in 2019.
    Response: The hospice payment update percentage and the application 
of the MFP are required by statute, as previously described in detail 
in this section, and we do not have regulatory authority to alter the 
update. Likewise, sequestration is determined outside of CMS' authority 
and the hospice payment updates are statutory.
    Final Decision: 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 2019 will be 1.8 percent for hospices that submit the required 
quality data and -0.2 percent (FY 2019 hospice payment update of 1.8 
percent minus 2 percentage points) for hospices that do not submit the 
required quality data.
3. FY 2019 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 CHC, 
IRC, or GIP. CHC is provided during a period of patient crisis to 
maintain the patient at home; IRC is short-term care to allow the usual 
caregiver to rest and be relieved from

[[Page 38631]]

caregiving; and GIP is to treat symptoms that cannot be managed in 
another setting.
    As discussed in the FY 2016 Hospice Wage Index and Rate Update 
final rule (80 FR 47172), we implemented two different RHC payment 
rates, one RHC rate for the first 60 days and a second RHC rate for 
days 61 and beyond. In addition, in that final rule, we implemented a 
Service Intensity Add-on (SIA) payment for RHC when direct patient care 
is provided by a RN or social worker during the last 7 days of the 
beneficiary's life. The SIA payment is equal to the CHC hourly rate 
multiplied by the hours of nursing or social work provided (up to 4 
hours total) that occurred on the day of service, if certain criteria 
are met. In order to maintain budget neutrality, as required under 
section 1814(i)(6)(D)(ii) of the Act, the new RHC rates were adjusted 
by a SIA budget neutrality factor.
    As discussed in the FY 2016 Hospice Wage Index and Rate Update 
final rule (80 FR 47177), we will continue to make the SIA payments 
budget neutral through an annual determination of the SIA budget 
neutrality factor (SBNF), which will then be applied to the RHC payment 
rates. The SBNF will be calculated for each FY using the most current 
and complete utilization data available at the time of rulemaking. For 
FY 2019, we calculated the SBNF using FY 2017 utilization data. For FY 
2019, the SBNF that would apply to days 1 through 60 is calculated to 
be 0.9991. The SBNF that would apply to days 61 and beyond is 
calculated to be 0.9998.
    In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 
52156), we initiated a policy of applying a wage index standardization 
factor to hospice payments in order to eliminate the aggregate effect 
of annual variations in hospital wage data. In order to calculate the 
wage index standardization factor, we simulate total payments using the 
FY 2019 hospice wage index and compare it to our simulation of total 
payments using the FY 2018 hospice wage index. By dividing payments for 
each level of care using the FY 2019 wage index by payments for each 
level of care using the FY 2018 wage index, we obtain a wage index 
standardization factor for each level of care (RHC days 1 through 60, 
RHC days 61+, CHC, IRC, and GIP). The wage index standardization 
factors for each level of care are shown in the tables below.
    The FY 2019 RHC rates are shown in Table 3. The FY 2019 payment 
rates for CHC, IRC, and GIP are shown in Table 4.

                                                       Table 3--FY 2019 Hospice RHC Payment Rates
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         SIA budget       Wage index        FY 2019
               Code                           Description                FY 2018         neutrality    standardization      hospice          FY 2019
                                                                      payment rates        factor           factor      payment  update   payment rates
--------------------------------------------------------------------------------------------------------------------------------------------------------
651...............................  Routine Home Care (days 1-60)..          $192.78         x 0.9991         x 1.0009          x 1.018          $196.25
651...............................  Routine Home Care (days 61+)...           151.41         x 0.9998         x 1.0007          x 1.018           154.21
--------------------------------------------------------------------------------------------------------------------------------------------------------


                            Table 4--FY 2019 Hospice CHC, IRC, and GIP Payment Rates
----------------------------------------------------------------------------------------------------------------
                                                                  Wage index        FY 2019
          Code               Description          FY 2018      standardization  hospice payment      FY 2019
                                               payment rates        factor           update       payment rates
----------------------------------------------------------------------------------------------------------------
652....................  Continuous Home              $976.42         x 1.0034          x 1.018          $997.38
                          Care; Full Rate =
                          24 hours of care;
                          $41.56 = FY 2019
                          hourly rate.
655....................  Inpatient Respite             172.78         x 1.0007          x 1.018           176.01
                          Care.
656....................  General Inpatient             743.55         x 1.0015          x 1.018           758.07
                          Care.
----------------------------------------------------------------------------------------------------------------

    Sections 1814(i)(5)(A) through (C) of the Act require that hospices 
submit quality data, based on measures to be specified by the 
Secretary. In the FY 2012 Hospice Wage Index final rule (76 FR 47320 
through 47324), we implemented a Hospice Quality Reporting Program 
(HQRP) as required by section 3004 of the PPACA. Hospices were required 
to begin collecting quality data in October 2012, and submit that 
quality data in 2013. Section 1814(i)(5)(A)(i) of the Act requires that 
beginning with FY 2014 and each subsequent FY, the Secretary shall 
reduce the market basket update by 2 percentage points for any hospice 
that does not comply with the quality data submission requirements with 
respect to that FY. The FY 2019 rates for hospices that do not submit 
the required quality data would be updated by the FY 2019 hospice 
payment update percentage of 1.8 percent minus 2 percentage points. 
These rates are shown in Tables 5 and 6.

                          Table 5--FY 2019 Hospice RHC Payment Rates for Hospices That Do Not Submit the Required Quality Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                            FY 2019
                                                                                                                            hospice
                                                                         FY 2018         SIA budget       Wage index    payment  update      FY 2019
               Code                           Description             payment rates      neutrality    standardization   of  1.8% minus   payment rates
                                                                                           factor           factor       2  percentage
                                                                                                                         points = -0.2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
651...............................  Routine Home Care (days 1-60)..          $192.78         x 0.9991         x 1.0009          x 0.998          $192.39
651...............................  Routine Home Care (days 61+)...           151.41         x 0.9998         x 1.0007          x 0.998           151.18
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 38632]]


  Table 6--FY 2019 Hospice CHC, IRC, and GIP Payment Rates for Hospices That Do Not Submit the Required Quality
                                                      Data
----------------------------------------------------------------------------------------------------------------
                                                                                    FY 2019
                                                                                hospice payment
                                                  FY 2018         Wage index     update of 1.8%      FY 2019
          Code               Description       payment rates   standardization      minus 2       payment rates
                                                                    factor         percentage
                                                                                 points = -0.2%
----------------------------------------------------------------------------------------------------------------
652....................  Continuous Home              $976.42         x 1.0034          x 0.998          $977.78
                          Care; Full Rate =
                          24 hours of care;
                          $40.74 = FY 2019
                          hourly rate.
655....................  Inpatient Respite             172.78         x 1.0007          x 0.998           172.56
                          Care.
656....................  General Inpatient             743.55         x 1.0015          x 0.998           743.18
                          Care.
----------------------------------------------------------------------------------------------------------------

    A summary of the comments we received regarding the payment rates 
and our responses to those comments appear below:
    Comment: Several commenters mentioned the SIA payment and stated 
that CMS should allow visits by Licensed Practical Nurses (LPNs) in the 
last 7 days of life to be eligible for SIA payment due to short length 
of stays and clinical demands of hospice patients.
    Response: We 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 2019 Hospice Wage Index and Payment Rate update 
proposed rule (83 FR 20934). However, we will continue to consider and 
monitor for potential refinements to this policy, including current 
monitoring efforts that were described in the FY 2019 Hospice Wage 
Index and Payment Rate Update proposed rule (83 FR 20934) in response 
to these policy changes, and we will take these comments into account 
as we continue to do so.
    Final Decision: We are implementing the updates to hospice payment 
rates as discussed in the proposed rule.
4. Hospice Cap Amount for FY 2019
    As discussed in the FY 2016 Hospice Wage Index and Rate Update 
final rule (80 FR 47183), we implemented changes mandated by the IMPACT 
Act of 2014 (Pub. L. 113-185). Specifically, for accounting years that 
end after September 30, 2016 and before October 1, 2025, the hospice 
cap is updated by the hospice payment update percentage rather than 
using the consumer price index for urban consumers (CPI-U). The hospice 
cap amount for the 2019 cap year will be $29,205.44, which is equal to 
the 2018 cap amount ($28,689.04) updated by the FY 2019 hospice payment 
update percentage of 1.8 percent.
    A summary of the comments we received regarding the hospice cap 
amount and our responses to those comments appear below:
    Comment: One commenter suggested resetting and lowering the cap 
amount by an additional 10 to 15 percent, which the commenter stated 
will help to keep intact the original intent of the hospice philosophy 
and shift the narrative back towards the spirit of the community.
    Response: We appreciate the commenter's suggestion that CMS should 
reset and lower the annual cap amount. However, the restriction set 
forth in section 1814(i)(2)(B) of the Act, as amended by section 3(d) 
of the IMPACT Act, does not give us discretion to adjust the cap 
amount.
    Final Decision: We are implementing the changes to the hospice cap 
amount as discussed in the proposed rule.

C. Request for Information Update--Comments Related to Hospice Claims 
Processing

    In the FY 2018 Hospice Wage Index and Rate Update proposed rule (82 
FR 20789), we solicited public comments to start a national 
conversation about improvements that can be made to the health care 
delivery system that reduce unnecessary burdens for clinicians, other 
providers, and patients and their families. We specifically stated that 
we would not respond to the comment submissions in the FY 2018 final 
rule. Instead, we would review the submitted request for information 
comments and actively consider them as we develop future regulatory 
proposals or future sub-regulatory policy guidance. After reviewing all 
submitted responses to our requests for information in the FY 2018 
proposed rule, one recommendation in particular warranted a revision to 
our current policy. Commenters suggested that CMS remove the 
requirement to report detailed drug data on the hospice claim as a way 
to reduce burden for hospices. We initially began asking for this 
information via Hospice Change Request 8358 in support of hospice 
payment reform (https://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/Hospice/Downloads/R2747CP.pdf).
    In the FY 2019 Hospice Wage Index and Rate Update proposed rule, 
(83 FR 20953), we provided an update that effective October 1, 2018, we 
proposed to no longer require the reporting of detailed drug data on 
the hospice claim as this information is not currently used for 
quality, payment, or program integrity purposes. Rescinding this 
requirement could result in a significant reduction of burden to 
Medicare hospices, potentially reducing the number of line items on 
hospice claims by approximately 21.5 million, in aggregate. Therefore, 
in the FY 2019 proposed rule, we stated that we would allow hospice two 
options for reporting hospice drug information: (1) Hospice providers 
would have the option to continue reporting infusion pumps and drugs, 
with corresponding NDC information, on separate line items on hospice 
claims, though it is no longer mandatory to report it this way; or (2) 
Hospice providers can submit total aggregate DME and drug charges on 
the claim.
    While the majority of commenters were supportive of this proposal 
and agreed that it would help to reduce regulatory burden, we did 
receive some comments primarily asking for more clarification regarding 
the options for reporting. A summary of the comments we received 
regarding this change in drug reporting and our responses to those 
comments appear below:
    Comments: Several commenters wanted to know if they needed to 
choose one option, and others requested clarification regarding options 
for submission. Some commenters asked if the reporting method could be 
determined on a case by case basis or if all claims had to be submitted 
using the same reporting option, meaning whether some claims could be 
reported with detailed line item information while others reported in 
the aggregate. One commenter suggested that it could be easier to 
report in the aggregate, depending on the responsiveness of the

[[Page 38633]]

physician or pharmacy that was involved in the patient's care. One 
commenter requested clarification if the claim would include all DME or 
just infusion pumps and drugs that were an item of DME. One commenter 
asked if this process would account for potential delay from receiving 
invoices from pharmacies. Several commenters raised concerns about the 
costs associated with retraining personnel to accurately capture claims 
data and vendor activities to build software and reports. Several 
commenters also noted concerns regarding whether there would be 
sufficient time for training and software revisions and testing prior 
to implementation.
    Response: We appreciate the commenters' feedback regarding this 
sub-regulatory change. We will allow hospices two options for reporting 
hospice drug information. Providers will have the option to continue to 
report infusion pumps and drugs, with corresponding NDC information, on 
the hospice claim as separate line items. This submission option will 
no longer be mandatory. Alternatively, hospices can submit total, 
aggregate DME and drug charges on the claim. At this time, there is no 
claims processing edit prohibiting providers to submit both separate 
line item drug data and aggregate drug data on the claim. However, we 
encourage providers to select one consistent mechanism for reporting 
this data. In order to implement this change, we have issued a detailed 
sub-regulatory change request, effective October 1, 2018, that provides 
further guidance. Change Request 10573 and related educational 
materials are available for review at the following URL: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4035CP.pdf.
    We received several comments that were outside the scope of the CY 
2019 Hospice Wage Index and Rate Update proposed rule. We received 
comments regarding the timely posting of beneficiary's hospice status 
in the Medicare system and the communication process between the CWF 
and the Part D MarX system, sequential billing, feedback on working 
with the Quality Improvement Organizations (QIOs) on beneficiary 
appeals of hospice discharges, the role of recreational therapy under 
the Medicare hospice benefit, and utilization of CHC and the midnight-
midnight rule.
    We thank commenters for their feedback and we will consider these 
suggestions for potential policy refinements. As we stated in the FY 
2018 proposed rule, we will actively consider all input as we develop 
future regulatory proposals or future sub-regulatory policy guidance.

D. Regulations Text Changes in Recognition of Physician Assistants as 
Designated Attending Physicians

    When electing the Medicare hospice benefit, the beneficiary agrees 
to forgo the right to have Medicare payment made for services related 
to the beneficiary's terminal illness and related conditions, except 
when such services are provided by the designated hospice and the 
beneficiary's designated attending physician as outlined in section 
1812(d)(2)(A) of the Act. The designated attending physician plays an 
important role in the care of a Medicare hospice beneficiary. If a 
beneficiary designates an attending physician, the beneficiary or his 
or her representative acknowledges that the identified attending 
physician was his or her choice and that the attending physician 
identified by the beneficiary, at the time he or she elects to receive 
hospice care, has the most significant role in the determination and 
delivery of the individual's medical care. The designated attending 
physician is required to certify that the beneficiary is terminally ill 
and participates as a member of the hospice IDG that establishes and/or 
or updates the individual's plan of care, ensuring that the Medicare 
beneficiary receives high quality hospice care.
    Under the current regulations at Sec.  418.3, the attending 
physician is defined as a doctor of medicine or osteopathy who is 
legally authorized to practice medicine or surgery by the state in 
which he or she performs that function, or a nurse practitioner, and is 
identified by the individual as having the most significant role in the 
determination and delivery of the individual's medical care. In the FY 
2019 Hospice Wage Index and Rate Update proposed rule (83 FR 20953), we 
stated that section 51006 of the Bipartisan Budget Act of 2018 (Pub. L. 
115-123) amended section 1861(dd)(3)(B) of the Social Security Act such 
that, effective January 1, 2019, physician assistants (PAs) will be 
recognized as designated hospice attending physicians, in addition to 
physicians and nurse practitioners. We proposed to change the 
definition of ``attending physician'' under Sec.  418.3 to include 
physician assistants (PAs).
    In the proposed rule, we also stated that, effective January 1, 
2019, Medicare will pay for medically reasonable and necessary services 
provided by PAs to Medicare beneficiaries who have elected the hospice 
benefit and who have selected a PA as their attending physician. PAs 
are paid 85 percent of the fee schedule amount for their services as 
attending physicians. Attending physician services provided by PAs may 
be separately billed to Medicare only if the PA is the beneficiary's 
designated attending physician, services are medically reasonable and 
necessary, services would normally be performed by a physician in the 
absence of the PA, whether or not the PA is directly employed by the 
hospice, and services are not related to the certification of terminal 
illness. Since PAs are not physicians, as defined in 1861(r)(1) of the 
Act, they may not act as medical directors or physicians of the hospice 
or certify the beneficiary's terminal illness and hospices may not 
contract with a PA for their attending physician services as described 
in section 1861(dd)(2)(B)(i)(III) of the Act, which sets out the 
requirements of the interdisciplinary group as including at least one 
physician, employed by or under contract with the agency or 
organization. All of these provisions apply to PAs without regard to 
whether they are hospice employees. We also proposed to amend 42 CFR 
418.304 (Payment for physician and nurse practitioner services) in the 
regulations to include the details outlined above regarding Medicare 
payment for designated hospice attending physician services provided by 
physician assistants.
    We solicited comments on the above proposals to expand the 
definition of ``attending physician'' at Sec.  418.3 to include 
physician assistants (PA), and to amend the regulations at Sec.  
418.304 to allow payment for PA attending physician services. A summary 
of the comments and our responses to those comments are provided below:
    Comment: Many commenters expressed support and appreciation for the 
inclusion of physician assistants as designated hospice attending 
physicians, as commenters noted that PAs have an important role in 
providing hospice care, including supplying care to rural areas, and 
believe that this change will increase access to hospice services for 
Medicare beneficiaries.
    Response: We thank commenters for their support. Inclusion of PAs 
in the definition of attending physician for the Medicare hospice 
benefit will lead to more flexibility for hospice beneficiaries and 
providers alike.
    Comment: Several commenters suggested aligning the nurse 
practitioner and physician assistant rules in regards to hospice face-
to-face encounters and

[[Page 38634]]

certifying terminal illness. One commenter stated that the exclusion of 
PAs from being able to provide the face-to-face encounter falls short 
of the goals of expanding the number of providers assisting this 
vulnerable population. This commenter stated that allowing PAs to 
conduct the face-to-face encounter and to certify terminal illness 
ensures greater continuity of care and prevent patients from having to 
engage with another healthcare professional for this encounter. One 
commenter recommended that the regulations at Sec.  418.22, which 
describe the requirements for the certification of terminal illness, be 
amended to include PAs. A commenter recommended that the regulations at 
Sec.  418.22 be amended to add physician assistant.
    Response: We appreciate commenters' suggestions that PAs be 
permitted to both perform hospice face-to-face encounters and certify 
terminal illness for hospice beneficiaries. As we described in the FY 
2019 Hospice Wage Index and Rate Update proposed rule (83 FR 20953), 
the BBA of 2018 did not make changes to allow PAs to certify terminal 
illness or perform the face-to-face encounter for Medicare 
beneficiaries. In regards to the certification of terminal illness, 
section 51006 of the BBA of 2018 amended section 1814(a)(7)(A)(i)(I) of 
the Act explicitly to exclude physician assistants from certifying 
terminal illness. We reiterate that no one other than a medical doctor 
or doctor of osteopathy can certify or re-certify terminal illness. 
Additionally, PAs were not authorized by section 51006 of the 
Bipartisan Budget Act of 2018 (Pub. L. 115-123) to perform the required 
hospice face-to-face encounter for re-certifications. The hospice face-
to-face encounter is required per section 1814(a)(7)(D)(i) of the Act, 
which continues to state that only a hospice physician or a hospice 
nurse practitioner can perform the encounter. We wish to note that the 
regulations at Sec.  418.22 will continue to state that the hospice 
face-to-face encounter must be performed by a hospice physician or 
hospice nurse practitioner and that only a medical doctor or doctor of 
osteopathy can certify or re-certify terminal illness.
    Comment: Several commenters suggested developing and supporting 
appropriate education and training programs for PAs and other 
clinicians who serve as attending physicians in hospice care to ensure 
that they have the experience and training needed to deliver quality 
end-of-life care to beneficiaries.
    Response: We appreciate the commenter's interest in the development 
of educational materials and programs for PAs regarding the role of the 
attending physician in the Medicare hospice benefit. We expect that 
providers will appropriately train staff according to the existing 
rules and regulations that govern Medicare hospice care and remain in 
compliance with state practice acts.
    Comment: A few commenters noted that there may be issues regarding 
state hospice licensure requirements and the scope of practice of PAs 
as an individual state. The commenters note that some states may not 
allow PAs to serve as the hospice patient's attending physician, and 
these state laws and regulations would apply.
    Response: We thank the commenter for noting that the states' scope 
of practice governance may not permit a PA to serve as a hospice 
beneficiary's attending physician. We note that hospice providers are 
responsible for reviewing the state hospice licensure requirements and 
scope of practice regulations for PAs to ensure that PAs are allowed to 
serve as a hospice patient's attending physician in accordance with 
state law and make staffing decisions accordingly.
    Comment: One commenter stated that an advanced registered nurse 
practitioner (ARNP) and a PA cannot be a member of the hospice 
interdisciplinary group (IDG) other than as the attending physician. 
The commenter suggested that CMS continue exploring how these 
credentialed healthcare providers can work at the top of their licenses 
and assist providers in gaining efficiency and enhancing the members of 
the IDG.
    Response: We thank the commenter for the comment regarding the 
composition of the IDG. The Condition of participation, 
``Interdisciplinary group, care planning, and coordination of 
services'', described at Sec.  418.56, states that ``the hospice must 
designate an interdisciplinary group or groups as specified in 
paragraph (a) of this section which, in consultation with the patient's 
attending physician, must prepare a written plan of care for each 
patient.'' Therefore, the attending physician, which could include an 
NP or a PA, does, in fact, play an essential role in the function of 
the IDG. Additionally, Sec.  418.56 states ``the interdisciplinary 
group must include, but is not limited to, individuals who are 
qualified and competent to practice in the following professional 
roles: (i) A doctor of medicine or osteopathy (who is an employee or 
under contract with the hospice). (ii) A registered nurse. (iii) A 
social worker. (iv) A pastoral or other counselor.'' The required 
members of the IDG are described in the CoPs, but other professionals, 
including NPs and PAs, are not excluded from participating in the IDG 
as appropriate for the beneficiary's plan of care.
    Final Decision: Effective for January 1, 2019, we are finalizing 
statutorily-required updates to the regulations to expand the 
definition of attending physician at Sec.  418.3 to include physician 
assistants (PA). We are also finalizing amendments to the regulations 
at Sec.  418.304 to include the details regarding Medicare payment for 
designated hospice attending physician services provided by physician 
assistants.

E. Proposed Technical Correction Regarding Hospice Cap Period 
Definition

    In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 
47142), we finalized aligning the cap period, for both the inpatient 
cap and the hospice aggregate cap, with the federal FY for FY 2017 and 
later. Therefore, the cap year now begins October 1 and ends on 
September 30 (80 FR 47186). We proposed to make a technical correction 
in Sec.  418.3 to reflect the revised timeframes for hospice cap 
periods. Specifically, we proposed that Sec.  418.3 would specify that 
the cap period means the twelve-month period ending September 30 used 
in the application of the cap on overall hospice reimbursement 
specified in Sec.  418.309.
    Additionally, we are making a technical correction in Sec.  418.309 
to reflect the revised timeframes for hospice cap periods. 
Specifically, we are inserting a reference to the definition of ``cap 
period'' as defined in Sec.  418.3 and removing language setting out 
specific month and day information. We inadvertently did not propose to 
amend the regulations at Sec.  418.309, but we now believe it is 
appropriate to make a technical correction to the regulations text; the 
specific changes we are making in the regulations simply codify the 
final policies previously finalized in the FY 2016 Hospice Wage Index 
and Rate Update final rule (80 FR 47142), and do not reflect any 
additional substantive changes.
    Final Decision: We did not receive any comments on our proposed 
changes therefore, we are finalizing the changes to the regulations 
text regarding the hospice cap period as discussed in the proposed 
rule.

[[Page 38635]]

F. Updates to the Hospice Quality Reporting Program (HQRP)

1. Background and Statutory Authority
    The Hospice Quality Reporting Program includes HIS and CAHPS. 
Section 3004(c) of the Affordable Care Act amended section 1814(i)(5) 
of the Act to authorize a quality reporting program for hospices. 
Section 1814(i)(5)(A)(i) of the Act requires that beginning with FY 
2014 and each subsequent FY, the Secretary shall reduce the market 
basket update by 2 percentage points for any hospice that does not 
comply with the quality data submission requirements for that FY. 
Depending on the amount of the annual update for a particular year, a 
reduction of 2 percentage points could result in the annual market 
basket update being less than 0 percent for a FY and may result in 
payment rates that are less than payment rates for the preceding FY. 
Any reduction based on failure to comply with the reporting 
requirements, as required by section 1814(i)(5)(B) of the Act, would 
apply only for the particular year involved. Any such reduction would 
not be cumulative nor be taken into account in computing the payment 
amount for subsequent FYs. Section 1814(i)(5)(C) of the Act requires 
that each hospice submit data to the Secretary on quality measures 
specified by the Secretary. The data must be submitted in a form, 
manner, and at a time specified by the Secretary.
2. General Considerations Used for Selection of Quality Measures for 
the Hospice QRP
a. Background
    The ``Meaningful Measures'' initiative is intended to provide a 
framework for quality measurement and improvement work at CMS. While 
this framework serves to focus on those core issues that are most vital 
to providing high-quality care and improving patient outcomes, it also 
takes into account opportunities to reduce paperwork and reporting 
burden on providers associated with quality measurement. To that end, 
we have begun assessing our programs' quality measures in accordance 
with the Meaningful Measures framework. We refer readers to the 
Executive Summary for more information on the ``Meaningful Measures'' 
initiative.
    Comment: CMS received several comments that supported the 
Meaningful Measures Initiative. Additionally, commenters stated that 
the ``Strengthen Person and Family Engagement as Partners in Their 
Care'' Quality Priority, as set out in 83 FR 20935 is an important area 
that is central to the provision of hospice care delivery. One 
commenter stated that the following Meaningful Measure Areas are 
applicable to hospice patients: End of Life Care according to 
Preferences, Patient's Experience of Care, Patient Reported Functional 
Outcomes (83 FR 20935). One commenter stated that adverse event 
reporting in the hospice setting can be challenging due to the variety 
of levels and settings of care. CMS received a few comments regarding 
quality measure development processes. Commenters recommended that CMS 
seek stakeholder input as part of the quality measure development 
process. Additionally, measure development across all care settings 
should consider special populations such as those that are terminally 
ill, and that expected declines in functional status due to advanced 
illness should not negatively impact the provider. Further, CMS should 
pursue development of quality measures that are important for hospice 
patients at the end of life, such as person and family engagement, pain 
and symptom management, effective communication, care coordination, and 
care concordant with patients' wishes. Finally, one commenter requested 
that CMS be transparent in its planning and development of potential 
HQRP quality measures and inform and engage stakeholders as frequently 
as possible.
    Response: Since no changes were proposed regarding Meaningful 
Measures or quality measure development processes, comments received 
are outside the scope of the current rule. We discuss quality 
development processes in the FY 2018 Hospice final rule (82 FR 36652 
through 36654), and we refer readers to that detailed discussion.
b. Accounting for Social Risk Factors in the Hospice QRP
    In the FY 2018 Hospice Wage Index final rule (82 FR 36652 through 
36654), we discussed the importance of improving beneficiary outcomes 
including reducing health disparities. We also discussed our commitment 
to ensuring that medically complex patients, as well as those with 
social risk factors, receive excellent care. We discussed how studies 
show that social risk factors, such as being near or below the poverty 
level, as set out annually in HHS guidelines, https://www.federalregister.gov/documents/2018/01/18/2018-00814/annual-update-of-the-hhs-poverty-guidelines, belonging to a racial or ethnic minority 
group, or living with a disability, can be associated with poor health 
outcomes and how some of this disparity is related to the quality of 
health care.\5\ Among our core objectives, we aim to improve health 
outcomes, attain health equity for all beneficiaries, and ensure that 
complex patients as well as those with social risk factors receive 
excellent care. Within this context, reports by the Office of the 
Assistant Secretary for Planning and Evaluation (ASPE) and the National 
Academy of Medicine have examined the influence of social risk factors 
in CMS value-based purchasing programs.\6\ As we noted in the FY 2018 
Hospice Wage Index final rule (82 FR 36652 through 36654), ASPE's 
report to Congress, which was required by section 2(d) of the IMPACT 
Act, found that, in the context of value-based purchasing programs, 
dual eligibility was the most powerful predictor of poor health care 
outcomes among those social risk factors that they examined and tested. 
ASPE is continuing to examine this issue in its second report required 
by the IMPACT Act, which is due to Congress in the fall of 2019. In 
addition, as we noted in the FY 2018 IPPS/LTCH PPS final rule (82 FR 
38428), the National Quality Forum (NQF) undertook a 2-year trial 
period in which certain new measures and measures undergoing 
maintenance review have been assessed to determine if risk adjustment 
for social risk factors is appropriate for these measures.\7\ The trial 
period ended in April 2017 and a final report is available at: http://www.qualityforum.org/SES_Trial_Period.aspx. The trial concluded that 
``measures with a conceptual basis for adjustment generally did not 
demonstrate an empirical relationship'' between social risk factors and 
the outcomes measured. This discrepancy may be explained in part by the 
``methods used for adjustment and the limited availability of robust 
data on social risk factors''. NQF has extended

[[Page 38636]]

the socioeconomic status (SES) trial,\8\ allowing further examination 
of social risk factors in outcome measures.
---------------------------------------------------------------------------

    \5\ See, for example United States Department of Health and 
Human Services. ``Healthy People 2020: Disparities. 2014.'' 
Available at: http://www.healthypeople.gov/2020/about/foundation-health-measures/Disparities; or National Academies of Sciences, 
Engineering, and Medicine. Accounting for Social Risk Factors in 
Medicare Payment: Identifying Social Risk Factors. Washington, DC: 
National Academies of Sciences, Engineering, and Medicine 2016.
    \6\ Department of Health and Human Services Office of the 
Assistant Secretary for Planning and Evaluation (ASPE), ``Report to 
Congress: Social Risk Factors and Performance Under Medicare's 
Value-Based Purchasing Programs.'' December 2016. Available at: 
https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
    \7\ Available at: http://www.qualityforum.org/SES_Trial_Period.aspx.
    \8\ Available at: http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=86357.
---------------------------------------------------------------------------

    In the FY 2018/CY 2018 proposed rules for our quality reporting and 
value-based purchasing programs, we solicited feedback on which social 
risk factors provide the most valuable information to stakeholders and 
the methodology for illuminating differences in outcomes rates among 
patient groups within provider that would also allow for a comparison 
of those differences, or disparities, across providers. Feedback we 
received across our quality reporting programs included encouraging CMS 
to explore whether factors that could be used to stratify or risk 
adjust the measures (beyond dual eligibility); considering the full 
range of differences in patient backgrounds that might affect outcomes; 
exploring risk adjustment approaches; and offering careful 
consideration of what type of information display would be most useful 
to the public.
    We also sought public comment on confidential reporting and future 
public reporting of some of our measures stratified by patient dual-
eligibility. In general, commenters noted that stratified measures 
could serve as tools for hospitals to identify gaps in outcomes for 
different groups of patients, improve the quality of health care for 
all patients, and empower consumers to make informed decisions about 
health care. We were encouraged to stratify measures by other social 
risk factors such as age, income, and educational attainment. With 
regard to value-based purchasing programs, commenters also cautioned 
CMS to balance fair and equitable payment while avoiding payment 
penalties that mask health disparities or discouraging the provision of 
care to more medically complex patients. Commenters also noted that 
value-based payment program measure selection, domain weighting, 
performance scoring, and payment methodology must account for social 
risk.
    As discussed in last year's final rule, 82 FR 36652 through 36654, 
we are considering options to improve health disparities among patient 
groups within and across hospitals by increasing the transparency of 
disparities as shown by quality measures. We also are considering how 
this work applies to other CMS quality programs in the future. We refer 
readers to the FY 2018 IPPS/LTCH PPS final rule (82 FR 38403 through 
38409) for more details, where we discuss the potential stratification 
of certain Hospital Inpatient Quality Reporting Program outcome 
measures. Furthermore, we continue to consider options to address 
equity and disparities in our value-based purchasing programs.
    We plan to continue working with ASPE, the public, and other key 
stakeholders on this important issue to identify policy solutions that 
achieve the goals of attaining health equity for all beneficiaries and 
minimizing unintended consequences.
    Comment: CMS received several comments that supported the 
administration's continued investigation of ways that social risk 
factors can be applied to quality measure development. Several 
commenters recommended additional research on the inclusion of social 
determinants of health in the development of quality measures, 
especially for those that apply to the seriously and terminally ill 
population. Commenters also provided several recommendations for 
possible social risk factors, including native language of the patient, 
income level, race and ethnicity, adequacy of caregiver support, 
presence of PTSD, and number of facility-based patients.
    Response: We appreciate commenters' continued support of our 
efforts to attain health equity for all beneficiaries. Since no changes 
were proposed to the social risk factors, comments received are outside 
the scope of the current rule. We addressed these issues in the FY 2018 
final rule (82 FR 36652 through 36654), and we refer readers to that 
detailed discussion.
c. New Measure Removal Factor
    In the FY 2016 Hospice Final Rule (80 FR 47186), we adopted seven 
factors for measure removal. We are adopting an eighth factor to 
consider when evaluating measures for removal from the HQRP measure 
set: The costs associated with a measure outweighs the benefit of its 
continued use in the program.
    As we discussed in the Executive Summary, we are engaging in 
efforts to ensure that the HQRP measure set continues to promote 
improved health outcomes for beneficiaries while minimizing the overall 
costs associated with the program. These costs are multi-faceted and 
include not only the burden associated with reporting, but also the 
costs associated with complying with the program. We have identified 
several different types of costs, including, but not limited to: (1) 
Provider and clinician information collection burden and burden 
associated with the submitting/reporting of quality measures to CMS; 
(2) the provider and clinician cost associated with complying with 
other Hospital IQR programmatic requirements; (3) the provider and 
clinician cost associated with participating in multiple quality 
programs, and tracking multiple similar or duplicative measures within 
or across those programs; (4) the cost to CMS associated with the 
program oversight of the measure including measure maintenance and 
public display; and/or (5) the provider and clinician cost associated 
with compliance to other federal and/or state regulations (depending 
upon the measure). For example, it may be needlessly costly and/or of 
limited benefit to retain or maintain a measure for which our analyses 
show no longer meaningfully supports program objectives (for example, 
informing beneficiary choice or payment scoring). It may also be costly 
for health care providers to track the confidential feedback and 
preview reports, as well as publicly reported information on a measure 
we use in more than one program. We may also have to expend unnecessary 
resources to maintain the specifications for the measure, including the 
tools we need to collect, validate, analyze, and publicly report the 
measure data. Furthermore, beneficiaries may find it confusing to see 
public reporting on the same measure in different programs. There also 
may be other burdens associated with a measure that arise on a case-by-
case basis.
    When these costs outweigh the evidence supporting the continued use 
of a measure in the HQRP, it may be appropriate to remove the measure 
from the program. Although we recognize that one of the main goals of 
the HQRP is to improve beneficiary outcomes by incentivizing health 
care providers to focus on specific care issues and making public data 
related to those issues, we also recognize that those goals can have 
limited utility where, for example, the publicly reported data is of 
limited use because it cannot be easily interpreted by beneficiaries 
and used to influence their choice of providers. In these cases, 
removing the measure from the HQRP may better accommodate the costs of 
program administration and compliance without sacrificing improved 
health outcomes and beneficiary choice.
    We will remove measures based on this factor on a case-by-case 
basis. We might, for example, decide to retain a measure that is 
burdensome for health care providers to report if we conclude that the 
benefit to beneficiaries justifies the reporting burden. Our goal is to 
move the program forward in the least burdensome manner possible, while

[[Page 38637]]

maintaining a parsimonious set of meaningful quality measures and 
continuing to incentivize improvement in the quality of care provided 
to patients.
    We solicited public comment on our proposal to adopt an additional 
measure removal factor, ``the costs associated with a measure outweighs 
the benefit of its continued use in the program,'' beginning with the 
FY 2019 Hospice Wage Index final rule. The vast majority of commenters 
supported our proposal to adopt an eighth criterion for measure 
removal. Most commenters were appreciative of CMS acknowledging burden 
of measures as an important criterion for retaining measures in the 
HQRP. However, one commenter disagreed with this proposal as discussed 
further below. A summary of the comments we received on this proposal 
and our responses to those comments appear below:
    Comment: Several commenters raised concerns and provided 
recommendations. Among those who supported the proposal, several 
commenters requested CMS seek public input before removing any measure 
from the HQRP under this criterion. Commenters noted that cost and 
benefits could be hard to define, and that interested parties may have 
different perspectives about relative costs versus benefits of a 
measure. Moreover, one commenter noted that benefits can be difficult 
to quantify (for example, timely care, good communication, quality of 
life). Thus, commenters recommended CMS seek public input prior to 
removing a measure based on this criterion in order to obtain 
meaningful stakeholder input on benefits of a measure, especially in 
instances where a measure may be costly, but provides value in 
distinguishing quality of hospice care. Commenters also recommended 
that if CMS decides a measure is appropriate for removal based on this 
criterion, that CMS announce removal of the measure through rulemaking.
    Response: We appreciate the commenters input regarding the measure 
removal factor. We agree with commenters who suggested that CMS seek 
public input prior to removing measures under this measure removal 
factor. We value transparency in our processes, and continually seek 
stakeholder input through education and outreach sessions, other 
webinars, rulemaking, and other collaborative engagements with 
stakeholders. We intend to continue to adopt and remove measures 
through our previously identified processes, which include notice and 
comment rulemaking for proposed adoption and removal of measures. The 
only exception to this is that we may immediately remove a measure from 
the Hospice Program if we identify the measure as having unintended 
consequences that may adversely affect patient safety.
    Comment: The commenter who disagreed with this proposal stated that 
the existing seven criteria were sufficient for determining removal of 
a measure from the HQRP, and stated the eighth factor could open the 
door for providers to argue for dropping a measure they do not want 
collected for reasons other than true cost versus benefit concerns (for 
example, arguing to drop a measure they are performing poorly on by 
stating the measure's costs outweigh the benefits).
    Response: We agree that it is possible that providers may recommend 
removal of measures they do not support based on the case that these 
measures are costly. However, input from providers is only one element 
of our case-by-case analysis of measures. We also intend to consider 
input from other stakeholders, including patients, caregivers, advocacy 
organizations, healthcare researchers, and other parties as appropriate 
to each measure. We will weigh the input received from stakeholders 
with our own analysis of each measure to make a case-by-case 
determination of whether it's appropriate to remove a measure based on 
its costs outweighing the benefit of its continued use in the program.
    Overall, in our assessment of measure sets across quality reporting 
and value-based purchasing programs under the Meaningful Measure 
Initiative, we identified measures that were no longer sufficiently 
beneficial to justify their costs within their respective programs. 
However, none of the previously finalized measure removal factors 
applied to these measures. Therefore, we determined that our measure 
removal factors were incomplete without this newly identified factor.
    Final Decision: After consideration of the comments, we are 
finalizing our proposal to adopt an additional measure removal factor 
for the HQRP, ``the costs associated with a measure outweighs the 
benefit of its continued use in the program,'' for FY 2019 and 
subsequent years.
3. Previously Adopted Quality Measures for FY 2019 Payment 
Determination and Future Years
    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 7 National 
Quality Forum (NQF)-endorsed measures for hospice:
     NQF #1617 Patients Treated with an Opioid who are Given a 
Bowel Regimen,
     NQF #1634 Pain Screening,
     NQF #1637 Pain Assessment,
     NQF #1638 Dyspnea Treatment,
     NQF #1639 Dyspnea Screening,
     NQF #1641 Treatment Preferences,
     NQF #1647 Beliefs/Values Addressed (if desired by the 
patient).
    We finalized the following 2 additional measures in the FY 2017 
Hospice Wage Index final rule, effective April 1, 2017. Data collected 
will, if not reported, affect payments for FY 2019 and subsequent 
years. (81 FR 52163 through 52173):
     Hospice Visits when Death is Imminent,
     Hospice and Palliative Care Composite Process Measure--
Comprehensive Assessment at Admission.
    The Hospice and Palliative Care Composite Process Measure--
Comprehensive Assessment at Admission measure (hereafter referred to as 
``the Hospice Comprehensive Assessment Measure'') underwent an off-
cycle review by the NQF Palliative and End-of-Life Standing Committee 
and successfully received NQF endorsement in July 2017.
    Data for the Hospice Visits when Death is Imminent measure pair is 
being collected using new items added to the HIS V2.00.0, effective 
April 1, 2017. This one measure comprises a measure pair assessing 
hospice staff visits to patients at the end of life. Measure 1: 
Percentage of patients receiving at least one visit from registered 
nurses, physicians, nurse practitioners, or physician assistants in the 
last 3 days of life. Measure 2: Percentage of patients receiving at 
least two visits from medical social workers, chaplains or spiritual 
counselors, licensed practical nurses or hospice aides in the last 7 
days of life. We will need at least 4 quarters of reliable data to 
conduct the necessary analyses to support submission to NQF. We will 
also need to assess the quality of data submitted in the first quarter 
of item implementation to determine whether they can be used in the 
analyses. We have begun analysis of the data, and, pending analysis, we 
will submit the Hospice Visits when Death is Imminent measure pair to 
NQF for endorsement review in accordance with NQF project timelines and 
call for measures. We will use a similar process to analyze and submit 
new quality measures to NQF for endorsement in future years. Providers 
will be notified of measure endorsement

[[Page 38638]]

and public reporting through sub-regulatory channels.
    In the FY 2015 Hospice Wage Index final rule (79 FR 50491 through 
50496), we also finalized the Consumer Assessment of Healthcare 
Providers and Systems (CAHPS[reg]) Hospice Survey to support quality 
measures based on patient and family experience of care. We refer 
readers to section III.F.5 of the FY 2019 final rule for details 
regarding the CAHPS[reg] Hospice Survey, including public reporting of 
selected survey measures.

  Table 7--Previously Finalized Quality Measures Affecting the FY 2019
               Payment Determination and Subsequent Years
------------------------------------------------------------------------
                                                  Year the measure was
       NQF No.             Hospice item set     first adopted for use in
                           quality measure          APU determination
------------------------------------------------------------------------
1641.................  Treatment Preferences..  FY 2016
1647.................  Beliefs/Values           FY 2016
                        Addressed (if desired
                        by the patient).
1634.................  Pain Screening.........  FY 2016
1637.................  Pain Assessment........  FY 2016
1639.................  Dyspnea Screening......  FY 2016
1638.................  Dyspnea Treatment......  FY 2016
1617.................  Patients Treated with    FY 2016
                        an Opioid Who are
                        Given a Bowel Regimen.
3235.................  The Hospice and          FY 2019
                        Palliative Care
                        Composite Process
                        Measure--Comprehensive
                        Assessment at
                        Admission.
TBD..................  Hospice Visits when      FY 2019
                        Death is Imminent.
------------------------------------------------------------------------

    A summary of the comments we received regarding Hospice Visits and 
our response to those comments appear below:
    Comment: CMS received several comments pertaining to the Hospice 
Visits when Death is Imminent Measure Pair. Even though commenters 
supported the Hospice Visits when Death is Imminent Measure Pair, they 
recommended updates to Measure Pair, such as excluding patients with a 
length of stay of 7 days or less, aligning the measure pair and the SIA 
reimbursement structure, and accounting for patient or family refusal 
of services in measure specifications.
    Response: Since no changes were proposed to Hospice Visits when 
Death is Imminent Measure Pair, comments received are outside the scope 
of the current rule. We addressed these issues in the FY 2017 final 
rule (81 FR 52162 through 52169), and we refer the reader to that 
detailed discussion.
4. 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. Revised Data Review and Correction Timeframes for Data Submitted 
Using the HIS
    In the FY 2015 Hospice Wage Index final rule (79 FR 50486), we 
finalized our policy requiring that hospices complete and submit HIS 
records for all patient admissions to hospice on or after July 1, 2014. 
For each HQRP reporting year, we require that hospices submit data in 
accordance with the reporting requirements specified in the FY 2015 
Hospice final rule (79 FR 50486) for the designated reporting period. 
Electronic submission is required for all HIS records. For more 
information about HIS data collection and submission policies and 
procedures, we refer readers to the FY 2018 Hospice Wage Index final 
rule (82 FR 36663) and the CMS HQRP website: http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html. For more information about 
CAHPS[reg] Hospice Survey data submission policies and timelines, we 
refer readers to section III.F.5 of the FY 2019 final rule.
    Hospices currently have 36 months to modify HIS records. However, 
only data modified before the public reporting ``freeze date'' are 
reflected in the corresponding CMS Hospice Compare website refresh. For 
more information about the HIS ``freeze date'', see the Public 
Reporting: Key Dates for Providers page on the CMS HQRP website: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Public-Reporting-Key-Dates-for-Providers.html.
    To ensure that the data reported on Hospice Compare is accurate, we 
proposed that hospices be provided a distinct period of time to review 
and correct the data that is to be publically reported. This approach 
would allow hospices a time frame in which they may analyze their data 
and make corrections (up until 11:59:59 p.m. ET of the quarterly 
deadline) prior to receiving their preview reports. Once the preview 
reports are received, it is infeasible to make corrections to the data 
underlying the quality measure scores that are to be made public. 
Therefore, we proposed that for data reported using the HIS that there 
be a specified time period for data review and a correlating data 
correction deadline for public reporting at which point the data is 
frozen for the associated quarter. Similar to the policies outlined in 
the FY 2016 SNF final rule (81 FR 24271) and the FY 2016 IPPS/LTCH 
final rule (80 FR 49754), at this deadline for public reporting, we 
proposed that data from HIS records with target dates within the 
correlating quarter become a frozen ``snapshot'' of data for public 
reporting purposes. Any record-level data correction after the date on 
which the data are frozen will not be incorporated into measure 
calculation for the purposes of public reporting on the CMS Hospice 
Compare website. For each calendar quarter of data submitted using the 
HIS, approximately 4.5 months after the end of each CY quarter we 
proposed a deadline, or freeze date for the submissions of corrections 
to records. We note that this new data correction deadline for HIS 
records is separate and apart from the established 30-day data 
submission deadline. More information about the data submission 
deadline can be found at https://www.cms.gov/Medicare/Quality-

[[Page 38639]]

Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/.
    Specifically, each data correction deadline will occur on the 15th 
of the CY month that is approximately 4.5 months after the end of each 
CY quarter, and hospices will have up until 11:59:59 p.m. ET on that 
date to submit corrections or requests for inactivation of their data 
for the quarter involved. For example, for data reported in CY Q1, the 
freeze date will be August 15th, for CY Q2 the freeze date will be 
November 15th and so on. Under this policy, any modification to or 
inactivation of records that occur after the proposed correction 
deadline will not be reflected in publicly reported data on the CMS 
Hospice Compare website. For example, for the data collected during the 
1st quarter, that is January 1st through March 31st of a given year, 
the hospice will have until 11:59:59 p.m. ET on August 15th of that 
year to ensure all of their data is correct. Any modifications to first 
quarter data that are submitted to us after August 15th would not be 
reflected during any subsequent Hospice Compare refresh. We believe 
that this is a reasonable amount of time to allow providers to make any 
necessary corrections to submitted data prior to public reporting. This 
revised policy aligns HQRP with the policies and procedures that exist 
in our other quality reporting programs including the post-acute care 
programs, which also enable providers to review their data and make 
necessary corrections within the specified time frame of approximately 
4.5 months following the end of a given CY quarter and prior to the 
public reporting of such data.
    We proposed that beginning January 1, 2019, HIS records with target 
dates on or after January 1, 2019 will have a data correction deadline 
for public reporting of approximately 4.5 months after the end of each 
CY quarter in which the target date falls, and that hospices will have 
until 11:59:59 p.m. ET on the deadline to submit corrections.
    We also proposed that for the purposes of public reporting, the 
first quarterly freeze date for CY 2019 data corrections will be August 
15, 2019. To accommodate those HIS records with target dates prior to 
January 1, 2019 and still within a target period for public reporting, 
we also proposed to extend to hospices the opportunity to review their 
data and submit corrections up until the CY 19 Q1 deadline of 11:59:59 
p.m. ET on August 15, 2019. Table 8 presents the proposed data 
correction deadlines for public reporting beginning in CY 2019.

  Table 8--Data Correction Deadlines for Public Reporting Beginning CY
                                  2019
------------------------------------------------------------------------
                                          Data correction deadline for
       Data reporting period *                 public reporting *
------------------------------------------------------------------------
Prior to January 1, 2019.............  August 15, 2019
January 1, 2019-March 31, 2019.......  August 15, 2019
April 1, 2019-June 30, 2019..........  November 15, 2019
July 1, 2019-September 30, 2019......  February 15, 2020
October 1,2019-December 31, 2019.....  May 15, 2020
------------------------------------------------------------------------
* This CY time period involved is intended to inform both CY 2019 data
  and to serve as an illustration for the review and correction
  deadlines that are associated with each calendar year of data
  reporting quarter.

    We received multiple comments pertaining to the revised data review 
and correction timeframes for data submitted using the HIS. A summary 
of the comments we received on this proposal and our responses to those 
comments appear below:
    Comment: A majority of the commenters supported the proposed 4.5 
month data correction deadline for publicly reported HIS data. 
Commenters noted that this timeframe was sufficient for providers to 
review their data and make necessary corrections prior to public 
reporting. One commenter questioned why CMS would create a shorter, 4.5 
month timeframe for data corrections when hospices may submit claims 
for services up to 12 months from the date of service. This commenter 
suggested that quality data corrections should be permitted for a 
similar amount of time. Additionally, CMS received one comment that 
emphasized the importance of widespread provider education related to 
the data correction deadline for public reporting of HIS data. This 
commenter stated that providers may experience challenges submitting 
and reviewing data in a shorter timeframe due to various circumstances, 
such as if the hospice is converting to a new EHR or if HIS data 
collection is not integrated into the hospice's routine assessment.
    Response: We appreciate the commenters' support of a 4.5 month data 
correction deadline for publicly reported HIS data. CMS expects that 
the data that hospices submit to CMS is as accurate as possible upon 
the initial submission of that data, and that corrections should not be 
the rule, but rather the exception here. When a hospice does need to 
make a modification or inactivation requests, they will continue to be 
permitted for up to 36 months from the assessment target date. However, 
HIS data that are submitted more than 4.5 months from the end of the 
corresponding CY quarter will impact data displayed on Hospice Compare 
because that data will not be reflected in the hospices measure scores 
that are displayed on Hospice Compare. More information about 
modification and inactivation requests can be found in the HIS Manual 
(Section 3.6) available under the downloads section of the HIS web page 
on the CMS HQRP website: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html.
    Requiring that data be reviewed and corrected for public reporting 
purposes within a defined period of time will result in more timely and 
accurate data on Hospice Compare, ensuring that consumers have access 
to a resource with consistent and accurate representations of hospice 
performance. We appreciate the commenter's recommendation to align HQRP 
and claims policy. Although this new policy will not align HQRP and 
claims data submission requirements, it will align the HQRP with the 
policies and procedures that exist in other quality reporting programs 
including the post-acute care programs. Based on experiences in other 
settings, this timeframe allows hospices sufficient time to submit, 
review, and correct their data prior to public reporting of that data.
    Finally, we agree that widespread education will be necessary to 
ensure that providers understand the data correction deadline for 
public reporting

[[Page 38640]]

of HIS data. We will provide future education and outreach activities 
to educate providers about the data correction deadline for public 
reporting through HQRP communication channels, which include postings 
on the CMS HQRP website, announcements in the MLN eNews, and Open Door 
Forums.
    Final Decision: After consideration of the comments, we are 
finalizing our proposal to implement public reporting data review and 
correction timeframes for data submitted using the HIS, starting on 
January 1, 2019.
5. CAHPS[reg] Hospice Survey Participation Requirements for the FY 2023 
APU and Subsequent Years
    The CAHPS[reg] Hospice Survey of CMS' HQRP is used to collect data 
on the experiences of hospice patients and the primary caregivers 
listed in their hospice records. Readers who want more information are 
referred to our extensive discussion of the Hospice Experience of Care 
prior to our proposal for the public reporting of measures may refer to 
79 FR 50452 and 78 FR 48261.
a. Background and Description of the CAHPS[reg] Hospice Survey
    The CAHPS[reg] Hospice Survey is the first standardized national 
survey available to collect information on patients' and informal 
caregivers' experience of hospice care. Patient-centered experience 
measures are a key component of the CMS Quality Strategy, emphasizing 
patient-centered care by rating experience as a means to empower 
patients and their caregivers and improving the quality of their care. 
In addition, the survey introduces standard survey administration 
protocols that allow for fair comparisons across hospices.
    Although the development of the CAHPS[reg] Hospice Survey predates 
the Meaningful Measures initiative, it used many of the Meaningful 
Measure principles in its development. The overarching quality priority 
of ``Strengthen Person and Family Engagement as Partners in Their 
Care'' includes Meaningful Measure areas such as ``Care is personalized 
and Aligned with Patient's Goals,'' ``End of Life Care According to 
Preferences'' and ``Patients Experience of Care.'' The survey questions 
were developed with input from caregivers of patients who died under 
hospice care. The survey focuses on topics that are meaningful to 
caregivers/patients and supports our efforts to put the patient and 
their family members first.
    Details regarding CAHPS[reg] Hospice Survey national 
implementation, survey administration, participation requirements, 
exemptions from the survey's requirements, hospice patient and 
caregiver eligibility criteria, fielding schedules, sampling 
requirements, survey instruments, and the languages that are available 
for the survey, are all available on the official CAHPS[reg] Hospice 
Survey website: https://www.HospiceCAHPSsurvey.org, and in the 
CAHPS[reg] Hospice Survey Quality Assurance Guidelines (QAG), which are 
posted on the website.
b. Overview of the CAHPS[reg] Hospice Survey Measures
    The CAHPS[reg] Hospice Survey is administered after the patient is 
deceased and queries the decedent's primary, informal caregiver 
(usually a family member) regarding the patient and family experience 
of care, unlike the Hospital CAHPS[reg] Survey deployed in 2006 (71 FR 
48037 through 48039) and other subsequent CAHPS[reg] surveys. National 
implementation of the CAHPS[reg] Hospice Survey commenced January 1, 
2015 as stated in the FY 2015 Hospice Wage Index and Payment Rate 
Update final rule (79 FR 50452).
    The survey consists of 47 questions and is available (using the 
mailed version) in English, Spanish, Chinese, Russian, Portuguese, 
Vietnamese, Polish, and Korean. It covers topics such as access to 
care, communications, getting help for symptoms, and interactions with 
hospice staff. The survey also contains 2 global rating questions and 
asks for self-reported demographic information (race/ethnicity, 
educational attainment level, languages spoken at home, among others). 
The CAHPS[reg] Hospice Survey measures received NQF endorsement on 
October 26th, 2016 (NQF #2651). Measures derived from the CAHPS[reg] 
Hospice Survey include 6 multi-item (composite) measures and 2 global 
ratings measures. They received NQF endorsement on October 26, 2016 
(NQF #2651). We adopted these 8 survey-based measures for the CY 2018 
data collection period and for subsequent years. These 8 measures are 
reported on Hospice Compare.
    Comment: CMS received several comments relating to the range of 
responses to the CAHPS Survey. One commenter stated that the range of 
positive versus negative responses is too narrow. Another commented on 
the validity of a measure ``when the national benchmark scores are all 
low in one area.'' This commenter also asks if anyone is evaluating 
these questions.
    Response: We are continually analyzing the Hospice CAHPS to ensure 
there is sufficient variation to justify their inclusion on Hospice 
Compare. Currently, the data show sufficient variability across 
hospices to justify their publication on Hospice Compare.
    As part of our application for re-endorsement of the CAHPS[reg] 
Hospice Survey Measures by the NQF next year (2019), the survey data 
will be fully analyzed again. The measures for the CAHPS[reg] Hospice 
Survey are reviewed by NQF, the CAHPS Consortium, and the Measures 
Application Partnership (MAP) which is a joint program through HHS and 
the NQF.
    We are uncertain what the commenter means by scores all being low 
in one area. We are not sure if this refers to the survey domain or a 
geographic region. Data may still be valid even if they demonstrate 
limited variability by domain or geographic area.
    Final Decision: After consideration of the comments, we are 
finalizing our proposal to continue treating the preferred language of 
the caregiver as a recommended variable.
c. Data Sources
    As discussed in the CAHPS[reg] Hospice Survey QAG V4.0 (http://www.hospiceCAHPSsurvey.org/en/quality-assurance-guidelines/), the 
survey has three administration methods: Mail only, telephone only, and 
mixed mode (mail with telephone follow-up of non-respondents). We 
previously finalized the participation requirements for the FY 2020, FY 
2021, and FY 2022 APUs (82 FR 36673). We proposed to extend the same 
participation requirements to all future years, for example, the FY 
2023, FY 2024 and FY 2025 Annual Payment and subsequent updates. To 
summarize, to meet the CAHPS[reg] Hospice Survey requirements for the 
HQRP, we proposed that hospice facilities must contract with a CMS-
approved vendor to collect survey data for eligible patients on a 
monthly basis and report that data to CMS on the hospice's behalf by 
the quarterly deadlines established for each data collection period. 
The list of approved vendors is available at: http://www.hospiceCAHPSsurvey.org/en/approved-vendor-list.
    Hospices are required to provide lists of the patients who died 
under their care, along with the associated primary caregiver 
information, to their respective survey vendors to form the samples for 
the CAHPS[reg] Hospice Survey. We emphasize the importance of hospices 
providing complete and accurate information to their respective survey 
vendors in a timely manner.
    Comment: One commenter suggested that we change the Quality 
Assurance Guidelines Manual for the CAHPS[reg]

[[Page 38641]]

Hospice Survey so that the ``preferred language'' variable would become 
a required field for hospices to submit to CMS.
    Response: We encourage hospices, with a significant caregiver 
population that speaks any of the languages the survey offers, to offer 
the CAHPS[reg] Hospice Survey in all applicable languages. CMS also 
encourages hospices that serve patient populations that speak languages 
other than those noted to request that CMS create an official 
translation of the CAHPS[reg] Hospice Survey in those languages. Send 
any requests to our technical assistance team at: 
[email protected] or call them at: 1-844-472-4621. Currently 
the survey is offered in English and Spanish for the mail and telephone 
versions of the survey. In addition the mail survey is offered in the 
following languages: Traditional and simplified Chinese, Russian, 
Vietnamese, Portuguese, Polish and Korean. Approximately 99 percent of 
the hospice surveys are completed in English.
    Final Decision: After consideration of the comments, we are 
finalizing our proposal to continue treating the preferred language of 
the caregiver as a recommended variable.
    Hospices must contract with an approved CAHPS[reg] Hospice Survey 
vendor to conduct the survey on their behalf. Hospices are responsible 
for making sure their respective survey vendors meet all data 
submission deadlines. Vendor failures to submit data on time are the 
responsibility of the hospices. We solicited public comment on this 
proposal.
    Comment: One commenter noted that validating their CAHPS Hospice 
survey data ``against the files that are submitted to the vendor is a 
multiple day process, and if discrepancies are identified, often the 
timeline for survey submission etc. has expired and no way to get those 
days back.'' This commenter further noted that there appear to be no 
repercussions for vendors who miss their data submission deadlines. The 
commenter also suggested that vendors also should have some 
responsibilities.
    Response: We appreciate the commenter's concerns about the process 
of submitting survey data to their vendor, however, we want to clarify 
that CMS has no legal authority to directly regulate survey vendors. We 
do encourage hospices to monitor their vendors by checking data 
submissions reports regularly to ensure that data are being submitted 
on time, and to hold their vendors accountable for performance issues.
    Comment: Two commenters described expenses associated with 
participating in the CAHPS Hospice Survey as unfunded burdens. One 
commenter indicated that providing a reimbursement rate close to the 
actual market basket rate would ensure the availability of funds to 
meet the additional administrative burden of the survey. The other 
commenter indicates the survey places an unfunded burden on hospices 
and requests that CMS consider including an additional administrative 
reimbursement mechanism to help cover these costs.
    Response: We take a number of steps to reduce the burden of the 
cost of participating in the CAHPS Hospice Survey. First, we exempt the 
smallest hospices from participating. Second, we approved a variety of 
modes of data collection (mail, telephone, and mail with telephone 
follow-up) which incur different costs. Third, we have approved a wide 
variety of vendors with different costs and mixed of services, so that 
hospices can choose the vendor that is most compatible with their 
needs.
    Comment: One commenter suggested fast-tracking studies to compare 
responses and response rates of alternative modes of conducting the 
survey, including using tablets, text messages, and other real-time 
survey options.
    Response: We have started examining the possibility of electronic 
survey options. What we have found out so far is that email or web-
based surveys alone often have very low response rates. Electronic 
surveys would be useful mostly to supplement current survey modes. We 
are continuing to explore email and web alternatives. We are not 
currently considering so called ``real-time'' modes of survey 
administration, such as in-person interviews with tablets. In-person 
interviewing is very expensive if conducted by a third-party vendor. It 
runs the risk of significant bias if the survey is conducted by a 
hospice staff member. For these reasons, we do not believe these are 
appropriate techniques for the CAHPS[reg] Hospice Survey. Text 
messaging is mostly useful for very short surveys or to provide a link 
to a web survey. We do not anticipate shortening our questionnaire to 
an extent that would be compatible with text messaging without a link. 
That said, we are continuing to examine the possibilities of using 
alternative survey methods across all of the CAHPS surveys.
    Comment: One commenter suggested that CMS review cover letters and 
phone script introductions for the CAHPS Hospice Survey. They stated 
that the current versions require too high a reading level.
    Response: The CAHPS Hospice Survey team has recently decided to 
launch a study of the cover letter and phone script to determine how it 
can be made more readable to all members of the public. This research 
will include a review of the grade level of each item and feedback from 
respondents.
    Final Decision: After consideration of the comments, we are 
finalizing our proposals to continuing to require that hospice 
providers use CMS-approved vendors to conduct the CAHPS[reg] Hospice 
Survey using one of the three approved modes, mail, telephone or mixed 
mode (mail with telephone follow-up).
d. Public Reporting of CAHPS[reg] Hospice Survey Results
    We began public reporting of the results of the CAHPS[reg] Hospice 
Survey on Hospice Compare as of February 2018. The first report of 
CAHPS[reg] data covered survey results from deaths occurring between 
Quarter 2, 2015 and Quarter 1, 2017. We report the most recent 8 
quarters of data on the basis of a rolling average, with the most 
recent quarter of data being added and the oldest quarter of data 
removed from the averages for each data refresh. We detailed the 
calculation of these measures in 82 FR 36674. We refresh the data 4 
times a year in the months of February, May, August, and November. We 
will not publish CAHPS[reg] data for any hospice that has fewer than 30 
completed surveys, due to concerns about statistical reliability. We 
proposed to use the same public reporting policies in future years.
    Comment: A couple of commenters suggested that CMS report more 
recent data for the CAHPS[reg] Hospice Survey by reducing the number of 
quarters of data being reported.
    Response: Currently, the CAHPS[reg] Hospice Survey reports data on 
Hospice Compare using a rolling average of the eight most recent 
quarters of data. We use 8 quarters to maximize the number of hospices 
that are included on the Compare site. Among the 4,643 hospices on the 
active agency list for the most recent public reporting period (Q4 
2015-Q3 2017), 61 percent (2,832) had 30 completes over 8 quarters (Q4 
2015-Q3 2017) and 49 percent (2,262) had 30 completes over 4 quarters 
(Q4 2016-Q3 2017). For this reason, we plan to continue to report eight 
quarters of data.
    Final Decision: After consideration of the comments, we are 
finalizing our proposal to continue to report eight quarters of data on 
Hospice Compare.

[[Page 38642]]

e. Volume-Based Exemption for CAHPS[reg] Hospice Survey Data Collection 
and Reporting Requirements
    We previously finalized a volume-based exemption for CAHPS[reg] 
Hospice Survey Data Collection and Reporting requirements in the FY 
2017 final rule (82 FR 36671). We proposed to continue our policy for a 
volume-based exemption for CAHPS[reg] Hospice Survey Data Collection 
for FY 2023 and every year thereafter. For example, for the FY 2023 
APU, hospices that have fewer than 50 survey eligible decedents/
caregivers in the period from January 1, 2020 through December 31, 2020 
(reference year) are eligible to apply for an exemption from CAHPS[reg] 
Hospice Survey data collection and reporting requirements (corresponds 
to the CY 2021 data collection period). To qualify, hospices must 
submit an exemption request form for the FY 2023 APU. The exemption 
request form is available on the official CAHPS[reg] Hospice Survey 
website: http://www.hospiceCAHPSsurvey.org.
    Hospices that intend to claim the size exemption are required to 
submit to CMS their total unique patient count for the period of 
January 1, 2020 through December 31, 2020 (reference year). The due 
date for submitting the exemption request form for the FY 2023 APU is 
December 31, 2021. Exemptions for size are active for 1 year only. If a 
hospice continues to meet the eligibility requirements for this 
exemption in future FY APU periods, the organization needs to request 
the exemption annually for every applicable FY APU period.
    For FY 2024 APU, hospices that have fewer than 50 survey eligible 
decedents/caregivers in the period from January 1, 2021 through 
December 31, 2021 (reference year) are eligible to apply for an 
exemption from CAHPS[reg] Hospice Survey data collection and reporting 
requirements. Hospices that intend to claim the size exemption are 
required to submit to CMS their total unique patient count for the 
period of January 1, 2021 through December 31, 2021. The due date for 
submitting the exemption request form for the FY 2024 APU is December 
31, 2022. Exemptions for size are active for 1 year only. If a hospice 
continues to meet the eligibility requirements for this exemption in 
future FY APU periods, the organization must request the exemption 
annually for every applicable FY APU period.
    For the FY 2025 APU, hospices that have fewer than 50 survey 
eligible decedents/caregivers in the period from January 1, 2022 
through December 31, 2022 (reference year) are eligible to apply for an 
exemption from CAHPS[reg] Hospice Survey data collection and reporting 
requirements for the FY 2025 payment determination. Hospices that 
intend to claim the size exemption are required to submit to CMS their 
total unique patient count for the period of January 1, 2022 through 
December 31, 2022. The due date for submitting the exemption request 
form for the FY 2025 APU is December 31, 2023. If a hospice continues 
to meet the eligibility requirements for this exemption in future FY 
APU periods, the organization must request the exemption annually for 
every applicable FY APU period.

                         Table 9--Size Exemption Key Dates FY 2023, FY 2024 and FY 2025
----------------------------------------------------------------------------------------------------------------
                                                           Reference year
                                                            (count total
              Fiscal year                Data collection      number of        Size exemption form  submission
                                              year         unique patients                deadline
                                                            in this year)
----------------------------------------------------------------------------------------------------------------
FY 2023...............................              2021              2020  December 31, 2021.
FY 2024...............................              2022              2021  December 31, 2022.
FY 2025...............................              2023              2022  December 31, 2023.
----------------------------------------------------------------------------------------------------------------

    We received no comments about the size exemption for hospices.
    Final Decision: We are finalizing our proposal to exempt to small 
hospices from data collection for the CAHPS[reg] Hospice Survey through 
FY 2015 and subsequent years.
f. Newness Exemption for CAHPS[reg] Hospice Survey Data Collection and 
Reporting Requirements
    We previously finalized a one-time newness exemption for hospices 
that meet the criteria (81 FR 52181). We proposed to continue the 
newness exemption for FY 2023, FY 2024, FY 2025, and all future years.
    Specifically, hospices that are notified about their Medicare CCN 
after January 1, 2021 are exempted from the FY 2023 APU CAHPS[reg] 
Hospice Survey requirements due to newness. Likewise, hospices notified 
about their Medicare CCN after January 1, 2022 are exempted from the FY 
2024 APU CAHPS[reg] Hospice Survey requirements due to newness. 
Hospices notified about their Medicare CCN after January 1, 2023 are 
exempted from the FY 2025 APU CAHPS[reg] Hospice Survey requirements 
due to newness. No action is required on the part of the hospice to 
receive this exemption. The newness exemption is a one-time exemption 
from the survey. We encourage hospices to keep the letter they receive 
providing them with their CCN. The letter can be used to show when you 
received your number.
    We proposed that this newness exemption to the CAHPS[reg] Hospice 
Survey will apply to all future years.
    Comment: One commenter stated that they supported a number of the 
changes being made permanent in this rule, including the ``newness'' 
exemption from the CAHPS survey, as well as the annual exemption for 
very small programs.
    Response: We appreciate the commenter's support. We have been 
extending the newness exemption to hospices since data collection 
started in 2015. Hospices that received their CMS Certification Number 
(CCN) after the start of the data collection year (January 1) are 
exempted from data collection for that year. CMS identifies the 
hospices that qualify for the newness exemption. We plan to continue to 
offer the newness exemption without change.
    Final Decision: After consideration of the comments, we are 
finalizing our proposal to continue offering the ``newness'' exemption 
for the CAHPS[reg] Hospice Survey to hospices that receive their CCN 
number after the data collection year starts.
g. Requirements for the FY 2023 APU
    To meet participation requirements for the FY 2023 APU, Medicare-
certified hospices must collect CAHPS[reg] Hospice Survey data on an 
ongoing monthly basis from January 2021 through December 2021 (all 12 
months) to receive their full payment for the FY 2023 APU. All data 
submission deadlines for the FY 2023 APU are in Table 10. CAHPS[reg] 
Hospice Survey vendors must submit data by the deadlines listed in 
Table 10 for all APU periods listed in the table and moving

[[Page 38643]]

forward. There are no late submissions permitted after the deadlines, 
except for extraordinary circumstances beyond the control of the 
provider as discussed above.

Table 10--CAHPS[reg] Hospice Survey Data Submission Dates for the APU in
                      FY 2023, FY 2024, and FY 2025
------------------------------------------------------------------------
                                        CAHPS Quarterly data submission
 Sample months \1\ (month of death)              deadlines \2\
------------------------------------------------------------------------
                               FY 2023 APU
------------------------------------------------------------------------
CY January-March 2021 (Quarter 1)...  August 11, 2021.
CY April-June 2021 (Q2).............  November 10, 2021.
CY July-September 2021 (Q3).........  February 9, 2022.
CY October-December 2021 (Q4).......  May 11, 2022.
------------------------------------------------------------------------
                               FY 2024 APU
------------------------------------------------------------------------
CY January-March 2022 (Q1)..........  August 10, 2022.
CY April-June 2022 (Q2).............  November 9, 2022.
CY July-September 2022 (Q3).........  February 8, 2023.
CY October-December 2022 (Q4).......  May 10, 2023.
------------------------------------------------------------------------
                               FY 2025 APU
------------------------------------------------------------------------
CY January-March 2023 (Q1)..........  August 9, 2023.
CY April-June 2023 (Q2).............  November 8, 2023.
CY July-September 2023 (Q3).........  February 14, 2024.
CY October-December 2023 (Q40)......  May 8, 2024.
------------------------------------------------------------------------
\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 the months August, November, February, and May.

h. Requirements for the FY 2024 APU
    To meet participation requirements for the FY 2024 APU, Medicare-
certified hospices must collect CAHPS[reg] Hospice Survey data on an 
ongoing monthly basis from January 2022 through December 2022 (all 12 
months) to receive their full payment for the FY 2024 APU. All data 
submission deadlines for the FY 2024 APU are in Table 10. CAHPS[reg] 
Hospice Survey vendors must submit data by the deadlines listed in 
Table 10 for all APU periods listed in the table and moving forward. 
There are no late submissions permitted after the deadlines, except for 
extraordinary circumstances beyond the control of the provider as 
discussed above.
i. Requirements for the FY 2025 APU
    To meet participation requirements for the FY 2025 APU, Medicare-
certified hospices must collect CAHPS[reg] Hospice Survey data on an 
ongoing monthly basis from January 2023 through December 2023 (all 12 
months) to receive their full payment for the FY 2025 APU. All data 
submission deadlines for the FY 2025 APU are in Table 10. CAHPS[reg] 
Hospice Survey vendors must submit data by the deadlines listed in 
Table 10 for all APU periods listed in the table and moving forward. 
There are no late submissions permitted after the deadlines, except for 
extraordinary circumstances beyond the control of the provider as 
discussed above.
j. For Further Information About the CAHPS[reg] Hospice Survey
    We encourage hospices and other entities to learn more about the 
survey on: https://www.hospiceCAHPSsurvey.org. For direct questions, 
contact the CAHPS[reg] Hospice Survey Team at 
[email protected] or telephone 1-844-472-4621.
6. 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. These procedures shall ensure that a 
hospice has the opportunity to review the data that is to be made 
public prior to such data being made public; the data will be available 
on our public website.
    To meet the PPACA's requirement for making quality measure data 
public, we launched the Hospice Compare website in August 2017. This 
website allows consumers, providers, and other stakeholders to search 
for all Medicare-certified hospice providers and view their information 
and quality measure scores. Since its release, the CMS Hospice Compare 
website has reported 7 HIS Measures (NQF #1641, NQF #1647, NQF #1634, 
NQF #1637, NQF #1639, NQF #1638, and NQF #1617). In February 2018, 
CAHPS[reg] Hospice Survey measures (NQF #2651) were added to the 
website.
a. Adding Quality Measures to Publically Available Websites--Procedures 
To Determine Quality Measure Readiness for Public Reporting
    Quality measures are added to Hospice Compare once they meet 
readiness standards for public reporting, which is determined through 
the following processes.
    First, we assess the reliability and validity of each quality 
measure to determine the scientific acceptability of each measure. This 
acceptability analysis is the first step in determining a measure's 
readiness for public reporting. We evaluate the quality measures using 
the NQF Measure Evaluation Criteria found on the NQF website here: 
http://www.qualityforum.org/Measuring_Performance/Submitting_Standards/Measure_Evaluation_Criteria.aspx#scientific. Analyses to assess 
scientific acceptability of new measures are important to determine if 
the measure produces reliable and credible results when implemented.

[[Page 38644]]

Reliability testing demonstrates that a measure is correctly specified 
by ensuring that ``measure data elements are repeatable, producing the 
same results a high proportion of time when assessed in the same 
population in the same time period and/or that the measure score is 
precise.'' Validity testing demonstrates that measure specifications 
are consistent with the focus of the measure and that the measure score 
can accurately distinguish between quality of care provided by 
providers. Reliability and validity are tested at both the data item 
and quality measure levels. For example, at the item-level, we examine 
the missing data rate and cross validate the data elements between the 
assessment data and Medicare claims to ensure validity of the data 
elements. At the quality measure level, we conduct split-half analysis, 
consistency analysis across time, stability analysis, and signal-to-
noise analysis to demonstrate the reliability of the measures. We 
examine the relationships between different quality measures assessing 
similar quality areas to demonstrate the validity of the quality 
measures.
    To establish reliability and validity of the quality measures, at 
least 4 quarters of data are analyzed. The first quarter of data after 
new adoption of, or changes to, standardized data collection tools may 
reflect the learning curve of the hospices; we first analyze these data 
separately to determine the appropriateness to use them to establish 
reliability and validity of quality measures.
    To further inform which of the measures are eligible for public 
reporting, we then examine 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. The 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 because, if a hospice QM score is generated from a 
denominator that is too small, the observed measure score may be a 
biased assessment of the provider's performance, yielding scores that 
are statistically unreliable. Thus, we have set a minimum denominator 
size for public reporting, as well as the data selection period 
necessary to generate the minimum denominator size for the CMS Hospice 
Compare website.
    This approach to testing reliability, validity, and reportability 
of quality measures (QMs) is consistent with the approach taken in 
other CMS quality reporting programs. Further, CMS provides hospices 
the opportunity to review their measures through their Certification 
and Survey Provider Enhanced Reports (CASPER) and additionally 
publishes the methodology related to the calculation of each quality 
measure in the Hospice Quality Measure User's Manual, which is updated 
with the addition of each quality measure to the Hospice QRP. Since 
December 2016, two provider feedback reports have been available to 
providers: The Hospice-Level Quality Measure Report and the Patient 
Stay-Level Quality Measure Report. These confidential feedback reports 
are available to each hospice using the CASPER system, and are part of 
the class of CASPER reports known as Quality Measure (QM) Reports. 
These reports are for the purposes of internal provider quality 
improvement and are available to hospices on-demand. We encourage 
providers to use the CASPER QM Reports to review their HIS quality 
measures regularly to ensure submitted quality measure data is correct. 
For more information on the CASPER QM Reports, we refer readers to the 
CASPER QM Factsheet on the HQRP website at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/HQRP-Requirements-and-Best-Practices.html.
    Because we follow the above outlined processes in determining the 
readiness for a quality measure to be publicly reported, and perform 
the necessary analysis to determine and demonstrate that our measures 
meet the NQF measure evaluation criteria prior to publicly reporting 
provider performance on these quality metrics, we proposed to announce 
to providers any future intent to publicly report an already-adopted 
quality measure on Hospice Compare or other CMS website, including 
timing, through sub-regulatory means.
    Conducting these analyses and announcing measure timelines and 
readiness for public reporting through sub-regulatory channels will 
allow us to implement measures for public reporting in a more 
expeditious, yet still transparent manner, benefitting the public by 
providing QM data as soon as it is determined to meet the minimum 
standards for public reporting. We will continue to provide updates 
about public reporting of QMs through the normal CMS HQRP communication 
channels, including postings and announcements on the CMS HQRP website, 
MLN eNews communications, national provider association calls, and 
announcements on Open Door Forums. Note that we are not making any 
changes to how CMS adopts substantive measures for the HQRP.
    We received multiple comments on this proposal to announce to 
providers any future intent to publicly report a quality measure on 
Hospice Compare, including timing, through sub-regulatory means. A 
summary of the comments we received on this topic and our responses to 
those comments are below:
    Comment: CMS received several comments on this proposal. Most 
commenters supported this proposal. Although commenters appreciated 
CMS' interest to move measures to public reporting in an expeditious 
manner, several commenters had concerns about this proposal and several 
were not supportive of it. Those who conditionally supported this 
proposal requested CMS develop separate processes for announcing 
readiness for public reporting and public reporting timelines for NQF- 
vs. non-NQF- endorsed measures. Some commenters stated that this 
proposal had the potential to reduce opportunities for public input and 
decrease transparency. Specific concerns from commenters are addressed 
in further detail below:
    Several commenters had concerns about this proposal; the majority 
of concerns stemmed from the desire to maintain transparency and 
opportunity for stakeholder input that CMS has established in the HQRP 
measure implementation processes to-date. Commenters appreciated CMS' 
methodical approach to-date and expressed concern that, without 
proposing public reporting implementation dates through rulemaking, 
there may not be opportunity for providers to comment, provide input, 
or give feedback before a public reporting date is set. One commenter 
stated that a sub-regulatory process may fracture communication 
channels for conveying information to the public, limiting opportunity 
for review and input.
    Apart from the annual rulemaking cycle, should CMS move forward 
with a sub-regulatory process, a couple of commenters suggested that 
CMS develop criteria that would guide CMS' decision regarding which 
measures are displayed on Hospice Compare, and that regardless of the 
channel (regulatory or sub-regulatory), CMS consider public comments 
and feedback on quality measures proposed to be added to Hospice 
Compare to promote transparency and to solicit provider input.
    Among conditionally supportive commenters, some recommended 
separate processes for NQF- vs non-

[[Page 38645]]

NQF-endorsed measures. Commenters stated that a sub-regulatory process 
would be appropriate for NQF-endorsed measures, as these measures will 
have undergone a thorough review process and the public will have had 
ample opportunity to comment on these measures. However, commenters 
stated that for measures that are not NQF-endorsed, it would be most 
appropriate for CMS to go through formal rulemaking processes prior to 
publishing these measures on Hospice Compare and for CMS to continue to 
submit such measures to public notice through rulemaking prior to any 
public display. Commenters suggested CMS to receive full stakeholder 
input through the rulemaking process on quality measures that are not 
NQF-endorsed.
    Other comments received related to this proposal included a 
statement from one commenter that it is ``too early'' to implement a 
sub-regulatory process, given the relative newness of the HQRP and 
Hospice Compare. Additionally, a couple of commenters recommended that 
in addition to the processes described in the proposed rule for 
assessing readiness (validity and reliability testing, etc.) and the 
NQF endorsement processes, CMS implement a user testing process that 
enables CMS to identify those measures for which performance can be 
translated into reliable and actionable information for beneficiaries.
    Response: We agree with commenters that a transparent process and 
allowing ample opportunity for public input prior to displaying a 
measure on Hospice Compare is a vital component of moving a measure 
from data collection to public reporting. We agree that stakeholder 
input is invaluable to this process, and our intent is to continue to 
communicate clearly with providers and continue to solicit their input 
on all aspects of the measure development lifecycle. As set out at 
section 1814(i)(5)(E) of the Act, the statutory requirements for public 
reporting of quality measures (1) allow providers an opportunity to 
review their data prior to public reporting of any data and (2) require 
CMS to display measures for public reporting. This is evidenced where 
the statute states: The ``Secretary shall establish procedures for 
making data . . . available to the public'' and ``the Secretary shall 
report quality measures that relate to hospice care provided by hospice 
program on the internet website of the Medicare & Medicaid Services.'' 
Now that we have communicated in this rule the procedure for 
determining readiness for public reporting through rulemaking, we can 
announce readiness and timelines for publicly reporting measures 
through sub-regulatory channels. The annual rulemaking cycle is not the 
only channel by which information can be communicated to the public in 
a transparent and collaborative manner. Sub-regulatory channels can be 
equally effective and timelier at communicating information to the 
public. Therefore, we view this proposal not as a loss of opportunity 
for dialogue or transparency, but as a way to change the channel by 
which we communicate with the public to receive input on one specific 
aspect of the QM development and implementation lifecycle. Moreover, we 
stated that this process has the potential to improve timeliness of 
communication with the public as we would no longer have to wait for 
the annual rulemaking cycle to commence conversations about readiness 
for public reporting. The commenters' concerns about transparency and 
public input can be addressed through sub-regulatory channels.
    In the context of commenters' concerns--especially those about NQF- 
vs. non-NQF-endorsed measures--we would like to clarify that this 
policy does not eliminate opportunities for providers to comment on the 
public reporting of newly adopted measures through rulemaking. 
Specifically, several commenters requested CMS ``ensure there is a 
formal public notice and comment process prior to publishing the 
measures on Hospice Compare'' and that CMS ``continue to submit such 
[non-NQF-endorsed] measures to public notice through rulemaking prior 
to any public display''. We would like to clarify that this policy will 
not change how measures are adopted in the HQRP, only how we 
communicate when measures are ready to be displayed on Hospice Compare. 
New measures to be adopted in the HQRP will have been reviewed and 
supported by the consensus-based entity Measure Application 
Partnership, convened by the NQF, and the public can comment on the 
measures as part of that process. We will continue to propose measures 
(NQF- or non-NQF-endorsed) for adoption in the HQRP through the annual 
rulemaking process, which will allow opportunities for providers to 
comment--through rulemaking--on proposed measures. When measures are 
proposed for initial adoption through rulemaking, providers have the 
opportunity to voice concerns about any aspect of the proposed measure, 
including public reporting. Thus, this policy aligns with commenters 
who requested that CMS ``ensure a formal public notice and comment 
process prior to publishing measures on Hospice Compare'' and that CMS 
``continue to submit such [non-NQF-endorsed] measures to public notice 
through rulemaking prior to any public display''.
    Regarding comments on the process that CMS uses to determine 
readiness for Hospice Compare, we direct providers to the text in the 
proposed rule, 83 FR 20960, which outlines our process for determining 
readiness for public display (for example, validity and reliability 
analyses; reportability analysis), which does include a user testing 
process.
    Final Decision: After consideration of the comments, we are 
finalizing our proposal to announce to providers any future intent to 
publicly report a quality measure on Hospice Compare or other CMS 
website, including timing, through sub-regulatory means.
b. Quality Measures To Be Displayed on Hospice Compare in FY 2019
    We anticipate that we will begin public reporting of the HIS-based 
Hospice Comprehensive Assessment Measure (NQF #3235), a composite 
measure of the 7 original HIS Measures (NQF #1641, NQF #1647, NQF 
#1634, NQF #1637, NQF #1639, NQF #1638, and NQF #1617), on the CMS 
Hospice Compare website in Fall 2018. For more information on how this 
measure is calculated, see the HQRP QM User's Manual v2.00 in the 
``Downloads'' section of the Current Measures page on the CMS HQRP 
website: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html. 
The reporting period for which the measure will be displayed on the CMS 
Hospice Compare website will align with the currently established 
procedures for the 7 HIS measures. For more information about reporting 
periods, see the Public Reporting: Key Dates for Providers page on the 
CMS HQRP website: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Public-Reporting-Key-Dates-for-Providers.html. We used the analytic approach 
described above to determine reliability, validity, and reportability 
of the HIS-based Hospice Comprehensive Assessment Measure (NQF #3235). 
Reliability and validity testing found that the Hospice Comprehensive 
Assessment Measure had high reliability and validity. For more 
information about the reliability and validity of this measure, see the 
NQF Palliative and End-of-Life Care Off-Cycle Measure Review 2017 
Publication available for

[[Page 38646]]

download here: https://www.qualityforum.org/Publications/2017/09/Palliative_and_End-of-Life_Care_Off-Cycle_Measure_Review_2017.aspx. Per 
the approach described above, we then conducted reportability analysis. 
Based on reportability analysis results, we determined this measure, 
calculated based on a 12-rolling month data selection period, to be 
eligible for public reporting with a minimum denominator size of 20 
patient stays. A majority of hospices, using rolling 4 quarters of 
data, have at least 20 patient stays eligible for the calculation and 
public reporting of the Hospice Comprehensive Assessment Measure. We 
plan to begin public reporting of the Hospice Comprehensive Assessment 
Measure with a minimum denominator size of 20.
    We also will begin public reporting of the HIS-based Hospice Visits 
when Death is Imminent Measure Pair in FY 2019. The same analytic 
approach described above will be applied to determine the reliability, 
validity, and reportability of the Hospice Visits when Death is 
Imminent Measure Pair. This measure pair assesses hospice staff visits 
to patients at the end of life. Draft specifications for the Hospice 
Visits when Death is Imminent measure pair are available on the CMS 
HQRP website here: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html. With the finalization of our proposal to announce future 
intentions to publicly display hospice quality measures through sub-
regulatory means, the exact timeline for public reporting of this 
measure pair will be announced through regular sub-regulatory channels 
once necessary analyses and measure specifications are finalized.
    A summary of the comments received and our responses to those 
comments are below:
    Comment: CMS received several supportive comments on the public 
display of the Hospice Comprehensive Assessment measure and the Hospice 
Visits when Death is Imminent Measure Pair in FY 2019. Most commenters 
focused on the Hospice Visits when Death is Imminent Measure Pair and 
were conditionally supportive of publicly reporting the measure pair. 
Those who were conditionally supportive asked that the measures be 
accompanied by text explaining the measures when publicly reported. CMS 
also received a comment opposing the public display of these measures 
in FY 2019, which is discussed below.
    Response: We appreciate the commenters' support of publicly 
displaying these two measures in FY 2019. We address commenters' 
specific concerns with respect to the public display of these measures 
below.
    Comment: CMS received one comment that oppose public display of the 
Hospice Comprehensive Assessment Measure and Hospice Visits when Death 
is Imminent Measure Pair in FY 2019. This commenter stated that 
stakeholders have not had enough feedback data on their own individual 
measure performance to become comfortable with these measures and take 
steps to improve their measure performance prior to public reporting. 
The commenter suggested that CMS finalize policies to ensure hospices 
are able to review, analyze, and act on measure performance data before 
they are publicly reported.
    Response: As statutorily required by section 1815(i)(5)(E) of the 
Act, we must ``ensure that a hospice program has the opportunity to 
review data that is to be made public with respect to the hospice 
program prior to such data being made public.'' As such, we are not 
only committed, but statutorily obligated, to ensuring providers have 
the opportunity to review, analyze, and act on measure performance data 
before any measure performance data are publicly displayed. In 
accordance with the statutory requirements of the Act, we implemented 
the CASPER QM reports and the Provider Preview Reports as the manner by 
which hospices review their data prior to public reporting. The Preview 
Reports allow providers the opportunity to view their data exactly as 
it will be displayed on Hospice Compare, prior to any display. Should a 
provider find an error in the data to be displayed, the provider can 
follow the established process to request review of the data 
inaccuracy; should the inaccuracy be verified, we suppress that 
provider's data for that quarter. This process provides a safeguard for 
ensuring that the data reported on Compare are accurate. In addition, 
the CASPER QM reports allow providers to view their performance prior 
to Preview reports and prior to any public display, thus giving 
providers the opportunity to identify areas for improvement and 
implement performance improvement projects prior to the start of public 
reporting. For more information about these reports, see section 
III.F.6a of this final rule. The Hospice Comprehensive Assessment 
Measure was added to the CASPER QM report in February 2018, allowing 
providers ample time to assess their performance on the measure and 
implement performance improvement projects as appropriate. We will also 
post the Hospice Visits when Death is Imminent Measure, which comprises 
a pair of measures, to the CASPER QM reports before public reporting of 
the measures so that providers can become familiar with them. Both 
measures, the Hospice Comprehensive Assessment Measure and Death is 
Imminent Measure, will also appear on providers' Preview Reports to 
ensure the scores to be displayed are accurate. Preview Reports will be 
released approximately 2 months prior to the Hospice Compare refresh in 
which measures are released. We will announce the timeline for 
reporting of these measures on the CASPER QM reports, Provider Preview 
Reports, and Hospice Compare once determined via the CMS HQRP website, 
listserv messages via the Post-Acute Care QRP listserv, MLN 
Connects[reg] National Provider Calls & Events, MLN Connects[reg] 
Provider eNews and announcements on Open Door Forums and Special Open 
Door Forums.
    Comment: Several commenters stated that the Hospice Visits when 
Death is Imminent Measure Pair, when publicly reported, may be 
confusing or misleading for consumers. For example, commenters shared 
that multiple factors, such as a patient and family's right to refuse 
visits, may account for lower performance on the measure pair. The 
commenters recommended that the measures be accompanied by text 
explaining this nuance when publicly reported.
    Response: We are committed to ensuring that all publicly reported 
data is presented in an appropriate and meaningful manner to the 
public. As such, we work with our website development contractor to 
ensure that the Hospice Compare website is regularly tested for 
usability, readability, and navigation. We complete user access testing 
(UAT) with each refresh of the Hospice Compare website to ensure that 
the publicly posted data is accurate and clear. Furthermore, text on 
the Hospice Compare website complies with the Plain Language Act of 
2010. In addition to complying with the Plain Language Act, we also 
take into account variations in health and general literacy, as well as 
solicit input from key stakeholders and technical experts in the 
development and presentation of publicly available data.
    As we add more measures to the Hospice Compare website, including 
the Hospice Comprehensive Assessment Measure and Hospice Visits when 
Death is Imminent Measure Pair, we will, with consultation from key 
stakeholders, carefully craft explanatory language to ensure that 
consumers understand the measure's intent, relationship to quality,

[[Page 38647]]

and any necessary measure-specific nuance.
    Comment: CMS received several general comments about public 
reporting of HIS-based measures. A few commenters were concerned that 
providers could easily change self-reported HIS data to avoid 
unfavorable scores being publicly reported on the Hospice Compare 
website. Another commenter stated that CMS should make more timely 
updates to quality data on Hospice Compare. This commenter stated that 
the lack of timely updates to the site may disincentive providers from 
implementing quality improvement efforts because it could take a year 
or longer to have updated data reflected on the Hospice Compare 
website. Another commenter stated that the measures currently on the 
Hospice Compare website were not clear as to if they are process 
measures, outcome measures, or measures of consumer feedback. Another 
commenter stated that consumers may misunderstand the current measures' 
intent and relationship to quality. Finally, CMS received one comment 
asking that CMS finalize policies so that measures will not be publicly 
posted based on the first year of performance data.
    Response: Because no changes were proposed to validation of HIS 
data, frequency of updates to Hospice Compare, process for writing text 
for Hospice Compare, or data eligible for public reporting, comments 
received are outside the scope of the current rule.
    We acknowledge the commenter's concern regarding the validity of 
self-reported HIS measures. Publicly reported QMs rely on the 
submission of valid and reliable data at the patient level. Our measure 
development contractor conducts ongoing testing and validation of the 
QM data to identify data irregularities and trends.
    Furthermore, we are taking steps to ensure that publicly reported 
data are accurate. See section III.F.4b for more details on our 
finalized proposal to add a 4.5 month data correction deadline for 
public reporting for HIS data. This deadline will ensure that providers 
cannot correct data indefinitely and result in consumers receiving an 
inconsistent and potentially inaccurate view of hospice performance. By 
ensuring that data are reviewed and corrected prior to public 
reporting, data on Hospice Compare will be a consistent and accurate 
representation of hospice performance.
    We are also committed to posting data on the Hospice Compare 
website that are as timely as possible. However, there will be an 
inevitable lag between data submission and public reporting on Hospice 
Compare to allow for sufficient time for us to process the data, 
including completing any required testing and validation, and for 
hospices to review and correct any inaccuracies. This lag in public 
reporting is consistent across Quality Reporting Programs.
    In reference to the text posted on Hospice Compare, we agree that 
it is important for consumers to be able to distinguish between 
process, outcome, and consumer feedback measures. Therefore, we have 
decided to separate the data into two sections on the Hospice Compare 
website: `Family experience of care' and `Quality of patient care'. 
Both sections have accompanying text explaining their data source. The 
website explains that the `Family experience of care' data comes from a 
national survey that asks a family member or friend of a hospice 
patient about their hospice care experience. The `Quality of patient 
care' section explains that this data is reported by hospices using the 
Hospice Item Set (HIS). Furthermore, we have included text explaining 
why these measures should be important to consumers.
    In response to the commenter's recommendation of finalized policies 
so that measures will not be publicly posted based on the first year of 
performance data, we would like to remind readers that quality measures 
are added to Hospice Compare once they meet NQF readiness standards for 
public reporting, which is determined through the process outlined in 
section III.F.6a of this final rule. We analyze at least the first year 
of performance data to establish reliability and validity of the 
quality measures. If this data and the resultant quality measure scores 
are found to be reliable, valid, and scientifically acceptable from 
comprehensive analyses, we would publicly report this data if they meet 
NQF readiness standards.
    Comment: A few commenters supported adding any new data to the 
Hospice Compare website. These commenters asked that no new data be 
added to Hospice Compare until after CMS correct any inaccurate data 
posted on the website. These commenters stated that the search function 
was returning inaccurate results and provider demographic data was 
incorrect on Hospice Compare. Moreover, the commenters stated that the 
data was updated too frequently, resulting in ``week-to-week'' changes 
and user confusion.
    Response: Because no changes were proposed to the Hospice Compare 
search functionality or posted demographic data, comments received are 
outside the scope of the current rule. However these comments made 
inaccurate statements that we want to correct. We are committed to 
posting accurate data to the Hospice Compare website, and goes to great 
lengths to ensure accuracy. Since the launch of the website, we would 
like to reassure the public of the accuracy of quality measure data on 
Hospice Compare. Quality measure data accuracy has never been 
questioned or an issue on Hospice Compare.
    The one area we have addressed is improving the accuracy of the 
demographic data and search function. We have been transparent about 
addressing these issues with communications provided on both the 
Hospice Quality Reporting and the Hospice Compare websites. As 
explained in our communications, the demographic data reflects what 
hospices have provided. Updates to demographic data need to be made 
through the hospice provider's MAC. Information about updating hospice 
demographic data can be found in the How to Update Demographic Data 
document in the downloads section of the Public Reporting: Background 
and Announcements page on the CMS HQRP website: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Public-Reporting-Background-and-Announcements.html. 
We also recognize that updates to provider's demographic data (for 
example, address, telephone number, ownership) may take up to 6-months 
to appear on the Hospice Compare website. The process to update 
demographic data is independent of updating quality measure data or 
service areas and is controlled by the Medicare Administrative 
Contractor (MAC). It is important for hospices to review their HIS and 
CAHPS[reg] Provider Preview Reports to verify that the demographic data 
is accurate. If inaccurate or outdated demographic data are included on 
the Preview Report or on Hospice Compare, hospice providers should 
follow guidance in the How to Update Demographic Data document in the 
downloads section of the Public Reporting: Background and Announcements 
page on the CMS HQRP website: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Public-Reporting-Background-and-Announcements.html.
    As for the search function, we agree with providers that the 
accuracy of the search function is integral to the success of any 
Compare website. The search function, though, relates only to 
demographic results. The resulting

[[Page 38648]]

quality data provided about each hospice is accurate and has always 
been, including from the launch of Hospice Compare website. The current 
search function file, uploaded in May 2018, has addressed the accuracy 
and specificity of the Compare search function, as it is based on three 
sources of data: Claims, HIS, and geographic data. In response to 
comments about the accuracy of the Hospice Compare search function, we 
appreciate commenters' concerns but believe that, since the launch of 
Compare, the refinements we have made to the data underlying the search 
function have addressed the accuracy of the search function. We strive 
to continually improve and will continue to refine methods and data 
underlying the search function as appropriate. At this time, the search 
function works well because it is based on the geographic data using 
Core-Based Statistical Areas (CBSAs) that match to the paid claims and 
reflect the service areas of the Medicare-certified hospices. Since 
claims data lag, the CBSA's reflect the service areas at that time. 
Therefore to add more timely service area data, the unique zip codes 
from the HIS files are added. Consequently any new zip codes added to a 
service area likely come from HIS data and thereby update the search 
function during these quarterly refreshes. This is expected as part of 
the search function in the same way that updates to HIS and CAHPS 
quality data are expected quarterly on Hospice Compare. Therefore, in 
response to the commenter's concern about frequency of data updates on 
Compare and how that impacts the consistency of the search function, we 
would like to note that the file used to power the search function is 
updated quarterly, at the same time we update the quality measure data 
displayed on Hospice Compare. These quarterly updates to Hospice 
Compare are the regular refresh timeframes for this website so that 
Hospice Compare provides users with updated data from HIS and 
CAHPS[reg] Hospice Surveys, which we believe stakeholders want the most 
recently available data. These quarterly refreshes also update the 
database of zip codes used to power the search function with new data 
collected from the HIS, providing a more comprehensive set of hospice 
service areas.
c. Updates to the Public Display of HIS Measures
    As discussed previously, we strive to put patients first, ensuring 
they are empowered to make decisions about their own healthcare, along 
with their clinicians, using data-driven information that are 
increasingly aligned with a parsimonious set of meaningful quality 
measures that drive quality improvement. We recognize that the HQRP 
represents a key component in bringing quality measurement, 
transparency, and improvement to the hospice care setting. To that end, 
we have begun analyzing our programs' measures in accordance with the 
Meaningful Measures framework to ensure high quality care that empowers 
patients to make decisions about their own healthcare, using 
consumable, data-driven information.
    With this framework in mind, we evaluated our measure set and 
specifically the measure Hospice and Palliative Care Composite Process 
Measure--Comprehensive Assessment at Admission (NQF #3235) which we 
intend to publicly display on the Hospice Compare website in FY 2019. 
Through feedback received, we have learned that while the 7 original 
HIS measures (NQF #1641, NQF #1647, NQF #1634, NQF #1637, NQF #1639, 
NQF #1638, and NQF #1617) that represent the individual care processes 
captured in this composite measure are important, the composite measure 
provides for consumers a more accessible measure for evaluating the 
quality of a hospice.
    The composite measure is more illustrative than the individual, 
high performing measures based on analyses. The hospice performance 
scores on the 7 component measures that comprise the composite measure 
are high (a score of 90 percent or higher on most component measures); 
however, analyses also show that, on average, a much lower percentage 
of patient stays received all seven desirable care processes at 
admission. Thus, by assessing hospices' performance of a comprehensive 
assessment through an all-or-none calculation methodology, the 
composite measure sets a higher standard of care for hospices and 
reveals a larger performance gap. Meaning, the composite measure holds 
hospices to a higher standard by requiring them to perform all seven 
care processes for a given patient admission. 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.
    The table below shows the mean measure score across all hospices 
for Hospice and Palliative Care Composite Process Measure--
Comprehensive Assessment Measure at Admission and the 7 component 
measures that will no longer be routinely individually displayed on 
Hospice Compare once the composite measure is displayed.

     Table 11--Mean Measure Score of the Hospice and Palliative Care
Composite Process Measure--Comprehensive Assessment Measure at Admission
                  and 7 Original HIS Component Measures
------------------------------------------------------------------------
                                                               Measure
                       Measure title                            score
                                                              (percent)
------------------------------------------------------------------------
Hospice and Palliative Care Composite Process Measure--             71.3
 Comprehensive Assessment at Admission (NQF #3235).........
Component Measure: Treatment Preferences (NQF #1641).......         98.8
Component Measure: Beliefs/Values (NQF #1647)..............         95.9
Component Measure: Pain Screening (NQF #1634)..............         93.2
Component Measure: Pain Assessment (NQF #1637).............         72.5
Component Measure: Dyspnea Screening (NQF #1639)...........         98.5
Component Measure: Dyspnea Treatment (NQF #1638)...........         92.8
Component Measure: Bowl Regimen (NQF #1617)................         97.5
------------------------------------------------------------------------

    Further, reporting of these 7 component measures alongside the 
composite measure may be redundant and may result in confusion and 
burden for users as they attempt to interpret data displayed on the 
Hospice Compare website. However, we also recognize that the component 
measures may be useful to some individuals using Hospice Compare. 
Therefore, while we will no longer directly display the 7 component 
measures as individual measures on Hospice Compare, once the composite 
measure is displayed, we will still provide the public the ability to 
view these component measures in a manner that avoids confusion on 
Hospice Compare. We plan to achieve this by reformatting the display of 
the component measures so that they are only viewable in an expandable/
collapsible format under the composite measure itself, thus allowing 
users the opportunity to view the component measure scores that were 
used to calculate the main composite measure score.
    This will change only the display of data on Hospice Compare for 
the HIS-based measure(s). This will not change any current HIS data 
collection procedures outlined in the FY 2018 Hospice final rule (82 FR 
36663 through 36664). Providers will still collect all

[[Page 38649]]

HIS items in the current version of the HIS (HIS V2.00.0), including 
the 7 aforementioned component measures. Providers will continue to 
follow the coding guidelines and policies outlined in the HIS Manual 
V2.00, which can be found under the Downloads section of the HIS page 
of the HQRP website https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html. Therefore, this change to the display of data on Hospice 
Compare will not impact data collection. Additionally, because the 
composite measure is composed of the 7 aforementioned component 
measures, these component measures will still be reported on CASPER QM 
reports and HIS provider preview reports for providers' internal 
quality purposes.
    We received multiple comments on this proposal to no longer 
directly display the 7 component measures as individual measures on 
Hospice Compare, once Hospice Comprehensive Assessment measure is 
displayed. A summary of the comments we received on this topic and our 
responses to those comments are below:
    Comment: CMS received multiple comments that were supportive of no 
longer directly displaying the 7 component HIS measures as individual 
measures on Hospice Compare once the Hospice Comprehensive Assessment 
measure is publicly reported. Commenters noted that displaying the 7 
component measures in an expandable/collapsible format under the 
Hospice Comprehensive Assessment measure is preferable for consumers. 
In addition to receiving comments indicating general support, 
commenters also raised several concerns about the proposed changes to 
display of HIS data on Compare.
    Response: We appreciate commenters' support of no longer directly 
displaying the 7 component HIS measures as individual measures on 
Hospice Compare once the Hospice Comprehensive Assessment measure is 
publicly reported. We address commenters' specific concerns with 
respect to the public display of the Hospice Comprehensive Assessment 
measure and its composite of the 7 component original HIS measures 
below.
    Comment: Many commenters stated that, since the Hospice 
Comprehensive Assessment measure is a composite of the 7 HIS measures, 
a low score for one of the 7 HIS measures could easily skew providers' 
scores on the Hospice Comprehensive Assessment measure. One commenter 
stated that this could be especially problematic for small hospice 
providers. Commenters stated that the reformatted display of Hospice 
Compare would make it more difficult for consumers to find or even hide 
the scores for the 7 component measures hospices were performing well 
and that may be more easily interpretable to them in favor of directly 
displaying the one Hospice Comprehensive Assessment measure with less 
favorable performance.
    Response: We agree with commenters that the 7 component HIS 
measures may be useful to some consumers of the site. Therefore, as 
stated in the proposed rule, we will not be removing the measures, nor 
will we obfuscate the display of these measures on Compare. We plan to 
display the 7 component HIS measures directly under the Hospice 
Comprehensive Assessment measure in an expandable/collapsible format. 
We will make it clear that the 7 component measures are available for 
those who would like more information about provider quality scores. 
Furthermore, as with the currently displayed HIS measures, we will 
include text explaining the Hospice Comprehensive Assessment measure 
and its relation to quality care.
    Analyses indicate that the Hospice Comprehensive Assessment measure 
is more illustrative than the component, high performing measures and, 
on average, a much lower percentage of patient stays received all 7 
desirable care processes at admission. Thus, by assessing hospices' 
performance of a comprehensive assessment through an all-or-none 
calculation methodology, the Hospice Comprehensive Assessment measure 
sets a higher standard of care for hospices and reveals a larger 
performance gap. This performance gap 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. Furthermore, discussions with key stakeholders 
indicate that, because of this performance gap, the Hospice 
Comprehensive Assessment measure is a more indicative measure for 
consumers when evaluating quality of care provided by a hospice. In 
summary, by directly displaying only this measure we will: (a) Provide 
consumers with one measure to easily compare providers on quality of 
care; and (b) incentivize hospices to conduct a greater number of care 
processes for as many patients as possible. We also recognize that the 
7 component measures are useful to consumers and we are committed to 
making them easily accessible, while keeping the Hospice Compare site 
as user-friendly as possible.
    As with the currently reported 7 HIS measures, the Hospice 
Comprehensive Assessment Measure will be reported with a minimum 
denominator size of 20 patient stays. This minimum denominator size 
ensures that quality measure scores are based on a large enough 
denominator to generate a statistically reliable score for public 
reporting. Therefore, hospices with small denominator sizes (<20 
patient stays) for the Hospice Comprehensive Assessment Measure, which 
may be at higher risk of a skewed score, will not have scores for this 
measure reported on Hospice Compare.
    Comment: Many commenters noted that many providers have high scores 
on the current seven HIS-based QMs and that the limited range of scores 
could make it difficult for consumers to differentiate between high- 
and low-quality providers. One commenter suggested eliminating the 
seven measures for this reason.
    Response: We agree that many hospice providers are performing well 
on the seven HIS-based QMs. The overall distribution and variability of 
the scores of the seven HIS QMs that are currently publicly displayed 
initially indicate that most hospices are completing the important care 
processes for most hospice patients around hospice admission. However, 
there is still noticeable room for improvement. Analysis completed by 
RTI International shows that a low percentage of hospices have perfect 
scores for most measures and a small percentage of hospices have very 
low scores. Moreover, interviews with caregivers found that public 
display of these measures would be useful in avoiding low-performing 
providers. Additionally, publicly reporting these measures inform 
consumers of the important care processes that they should expect upon 
hospice admission. Last but not the least, the seven HIS QMs allow 
consumers to review the QMs associated with the individual care 
processes that they feel are particularly applicable to them.
    Final Decision: After consideration of the comments, we are 
finalizing our proposal to no longer directly display the 7 component 
measures as individual measures on Hospice Compare, once the Hospice 
Comprehensive Assessment measure is displayed.
d. Display of Public Use File Data and/or Other Publicly Available CMS 
Data on the Hospice Compare Website
    In the FY 2016 Hospice Wage Index final rule (80 FR 47199), we 
announced that we would make available hospice data in a public data 
set, the Medicare

[[Page 38650]]

Provider Utilization and Payment Data: Physician and Other Supplier 
Public Use File (PUF), as part of our ongoing efforts to make 
healthcare more transparent, affordable, and accountable. Hospice data 
has been available at the provider-level in the Medicare Provider 
Utilization and Payment Data: Physician and Other Supplier PUF since 
2016 and is located at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Hospice.html. The primary data source for the Hospice PUF is the 
CMS Chronic Condition Data Warehouse (CCW), a database with 100 percent 
of Medicare enrollment and fee-for-service adjudicated claims data.
    These Hospice PUFs serve as a resource for the health care 
community by providing information on services provided to Medicare 
beneficiaries by hospice providers. The Hospice PUF contains 
information on utilization, payment (Medicare payment and standard 
payment), submitted charges, primary diagnoses, sites of service, and 
hospice beneficiary demographics organized by CMS Certification Number 
(6-digit provider identification number) and state. While these files 
are extensively downloaded by the public and especially researchers, 
currently the files are not in a format that would be considered user-
friendly for many of the consumers who would look for hospice 
information to support provider selection.
    As part of our ongoing efforts to make the Hospice Compare website 
more informative to our beneficiaries, loved ones, and their families, 
we proposed to post information from these PUF and/or other publicly 
available CMS data to the Hospice Compare website in a user-friendly 
way. We proposed to use information available in these public files to 
develop a new section of the Hospice Compare website that will provide 
additional information along with the HIS and CAHPS[supreg] quality 
measures and demographic information already displayed. Other Compare 
websites, such as the Nursing Home Compare and the End Stage Renal 
Disease Compare websites, have an information section similar to what 
we anticipate posting.
    Information on the Hospice Compare website for each hospice 
includes data from the PUF and/or other publicly available CMS data 
displayed in a consumer-friendly format. This means that we may display 
the data as shown from the PUF or present the data after additional 
calculations. For example, the data could be averaged over multiple 
years, displayed as a percentage rather than the raw number so it has 
meaning to end-users, or other calculations in a given year or over 
multiple years. Any calculation will be performed on data exclusively 
from the source file like the PUF or other publicly available CMS data. 
The data may be displayed with supporting narrative when needed to make 
the data more understandable.
    Examples, provided for illustration of how CMS could use the PUF or 
other publicly available CMS data, include:
     Percent of days a hospice provided routine home care (RHC) 
to patients, averaged over multiple years,
     Percent of primary diagnosis of patients served by the 
hospice (cancer, dementia, circulatory/heart disease, stroke, 
respiratory disease) which would be a calculation of the total number 
of patients by diagnosis and dividing by the total number of patients 
that the hospice served, and
     Site of service (long term care or non-skilled nursing 
facility, skilled nursing facility, inpatient hospital) with a notation 
of yes, based on whether the hospice serves patients in that facility 
type.
    While these types of information are not quality measures, they 
capture information that many consumers seek during the provider 
selection process and, therefore, will help them to make an informed 
decision. For example, information about conditions treated by the 
hospice could show a patient with dementia if a hospice specializes or 
is experienced in caring for patients with this condition. 
Additionally, if a patient has a specific need, like receiving hospice 
care in a nursing home, information from the PUF could help this 
patient or their loved ones determine if a provider in their service 
area has provided care in this setting. Analyses of the PUF data show 
variation between hospice providers in the data points outlined above, 
indicating that these data points could be meaningful to consumers in 
comparing services provided by hospices based on the factors most 
important to them. PUF data can serve as one more piece of information, 
along with quality of care metrics from the HIS and CAHPS[supreg] 
Hospice Survey, to help consumers effectively and efficiently compare 
hospice providers and make an informed decision about their care in a 
stressful time.
    By averaging or trending data over multiple years, the data applies 
to hospices broadly regardless of size or location or other factors. We 
anticipate that over time and as appropriate, we may add other items 
from the PUF or other publicly available CMS data to the Hospice 
Compare website through sub-regulatory processes and plan to inform the 
public through regular HQRP communication strategies, such as Open Door 
Forums, Medicare Learning Network, Spotlight announcements and other 
opportunities.
    We received multiple comments on this proposal to add data from the 
Hospice PUF to Hospice Compare. A summary of the comments we received 
and our responses to those comments are below:
    Comment: A majority of commenters supported the plan to post 
information from the PUF and/or other publicly available CMS data on 
the Hospice Compare website. Commenters stated this information would 
``give users additional insight into the industry and the specific 
provider.'' Of those that were supportive, some were conditionally 
supportive. Those commenters supported display of PUF data as long as 
the public is involved in decision-making as to which data points would 
be posted and how. Those who supported the proposal stated that posting 
of PUF data could lead to consumer confusion and unintended 
consequences.
    Response: We thank commenters for their support of this plan to 
post information from the PUF and/or other publicly available CMS data 
on the Hospice Compare website. We address commenters' specific 
concerns below.
    Comment: In addition to the three data points outlined in the 
proposal, several commenters suggested CMS add other data points from 
the PUF to Hospice Compare. Commenters suggested data points such as 
hospice size and business model.
    Response: We support these commenters' suggestions. The purpose of 
adding information from the PUF or other publically available CMS data 
is to provide additional useful information to consumers as they 
consider hospice. We will take these into consideration as we determine 
which data points will be added to Hospice Compare.
    Comment: Many commenters stated that displaying data from the PUF 
would be misleading for consumers since consumers may misinterpret this 
data as quality data. For this reason, some commenters supported 
posting PUF data to Hospice Compare. To mitigate any potential consumer 
confusion, commenters suggested that CMS solicit input from 
stakeholders, through rulemaking or other stakeholder engagement 
activities, to guide decisions on (1) what type of information is 
displayed on Hospice Compare, (2) what kind of transformations or 
calculations are done

[[Page 38651]]

to the data before it is publicly posted, and (3) how the data that is 
to be displayed will be explained in a consumer-friendly manner. One 
commenter also suggested CMS mature the PUF data before use.
    Response: We agree that it is important to clearly distinguish 
between PUF data, which is informational data and quality measure data 
posted to Hospice Compare. As such, we plan to display data from the 
PUF in a distinct section of the Hospice Compare website, separate from 
the sections containing HIS and CAHPS[supreg] quality data. This will 
be similar to the approach taken on other CMS Compare websites. We will 
also include text to explain the data displayed from the PUF and will 
make clear this data provides information about hospice characteristics 
and is not a reflection of the quality of care a hospice provides. As 
with other data and text currently on Hospice Compare, we will, with 
consultation from key stakeholders, carefully craft explanatory 
language to ensure that consumers understand the PUF data and how the 
data are meant for informational purposes only.
    We are committed to soliciting input from providers, key 
stakeholders, and the public when considering any refinements to 
Hospice Compare, including addition of PUF and/or other publicly 
available CMS data. As discussed in our response in section III.F.6a, 
the annual rulemaking cycle is not the only method by which this 
information can be communicated to the public and feedback can be 
solicited. Sub-regulatory channels can be equally or more effective at 
communicating and collaborating with the public since we can 
communicate more frequently through sub-regulatory means like Open Door 
Forums, Special Open Door Forums, and Medicare Learning Network, HQRP 
Spotlight Page and its other web pages.
    In reference to the comment suggesting ``maturing'' of PUF data 
before public reporting, we would like to clarify that PUF data is 
based on 100 percent fee-for-service final action claims. Thereby, the 
PUF reports out the hospices' data from their paid claims using data 
files that were produced after 24 months of maturity. Therefore, 
stakeholders have confidence in this data that will be used on Hospice 
Compare. We would also note that the PUF data are currently reported on 
our website for the public and that this data will be reported in a 
more user-friendly format to improve usability by consumers. For more 
information about the PUF and methodology used to calculate the data, 
see the Medicare Hospice Utilization & Payment Public Use File: A 
Methodological Overview here: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Downloads/Hospice_Methodology.pdf.
    Comment: A few commenters shared that the display of PUF data on 
Hospice Compare could lead to unintended consequences and, therefore, 
were unsupportive of displaying this data. Specifically, commenters 
shared that posting data about primary diagnoses served could lead 
consumers to falsely assume a hospice does not serve a particular 
diagnosis group, and that this would disproportionately affect small 
hospices.
    Response: We agree that it is important to prevent unintended 
consequences of publicly posted data. To mitigate concerns, we plan to 
(1) average data over multiple years and (2) include text explaining 
the purpose of these data points and how consumers can use them. By 
averaging data over multiple years, changes in case mix from year-to-
year will be accounted for. Moreover, data for small providers (<=10 
hospice beneficiaries in a calendar year) or data points with <=10 
beneficiaries (that is, if a provider had <=10 beneficiaries with a 
primary diagnosis of, for example, cancer) are suppressed in the PUF 
and cannot be displayed on Hospice Compare. We will make clear that 
information from the PUF is one more resource along with, but separate 
from, the quality of care data to help consumers make a more informed 
choice of hospice provider.
    Final Decision: After consideration of the comments, we are 
finalizing our proposal to display data from the Hospice PUF on Hospice 
Compare.
    Comment: CMS received several comments related to the Hospice 
Evaluation & Assessment Reporting Tool (HEART). Commenters highlighted 
the importance of developing a tool that reflects the holistic nature 
of hospice and expressed curiosity related to the timeline for HEART 
implementation and next steps for HEART development. Additionally, 
commenters emphasized the importance of using widespread processes to 
gather provider input related to HEART and ongoing education and 
support for future HEART implementation. Finally, commenters requested 
that HEART pilot test findings be broadly disseminated and explored, 
and that public comment be solicited through traditional rulemaking, 
prior to industry-wide implementation.
    Response: Because no changes were proposed to the potential new 
hospice data collection mechanism that is preliminarily being called 
the HEART, comments received are outside the scope of the current rule. 
We addressed these issues in the FY 2018 Hospice Wage Index final rule 
(82 FR 36638), and we refer the reader to that detailed discussion and 
the HQRP web page on HEART at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/index.html.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are solicited public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements.

A. ICRs Regarding Hospice Item Set

    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 7 NQF 
endorsed measures for hospice:
     NQF #1617 Patients Treated with an Opioid who are Given a 
Bowel Regimen,
     NQF #1634 Pain Screening,
     NQF #1637 Pain Assessment,
     NQF #1638 Dyspnea Treatment,
     NQF #1639 Dyspnea Screening,
     NQF #1641 Treatment Preferences,
     NQF #1647 Beliefs/Values Addressed (if desired by the 
patient).
    We finalized the following two additional measures in the FY 2017 
Hospice Wage Index final rule affecting FY 2019 payment determinations 
(81 FR 52163 through 52173):

 Hospice Visits when Death is Imminent

[[Page 38652]]

 Hospice and Palliative Care Composite Process Measure--
Comprehensive Assessment at Admission

    We received no comments on the ICRs Regarding Hospice Item Set.
    In section III.F of this rule, we are reformatting the 7 original 
HIS measures for purposes of public reporting display on Hospice 
Compare. This will not change any current HIS data collection 
procedures outlined in the FY 2018 Hospice final rule (82 FR 36663 
through 36664). The HIS V2.00.0 was approved by the OMB on April 17, 
2017 under OMB control number 0938-1153 (CMS-10390) for 1 year. The 
information collection request (ICR) is currently pending OMB approval 
for 3 years.

B. ICRs Regarding CAHPS[reg] Hospice Survey

    National Implementation of the Hospice Experience of Care Survey 
(CAHPs Hospice Survey) data measures (82 FR 36672) would not impose any 
new or revised reporting, recordkeeping, or third-party disclosure 
requirements and therefore, does not require additional OMB review 
under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.). The information collection requirements and burden have 
been approved by OMB through December 31, 2020 under OMB control number 
0938-1257 (CMS-10537).

C. Submission of PRA-Related Comments

    We have submitted a copy of this final rule to OMB for its review 
of the rule's information collection and recordkeeping requirements. 
The requirements are not effective until they have been approved by 
OMB.

V. Regulatory Impact Analysis

A. 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 would also update payment rates for each 
of the categories of hospice care, described in Sec.  418.302(b), for 
FY 2019 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). Lastly, 
section 3004 of the PPACA amended the Act to authorize a quality 
reporting program for hospices and this rule discusses changes in the 
requirements for the hospice quality reporting program in accordance 
with section 1814(i)(5) of the Act.

B. Overall Impacts

    We estimate that the aggregate impact of the payment provisions in 
this rule will result in an increase of $340 million in payments to 
hospices, resulting from the hospice payment update percentage of 1.8 
percent. The impact analysis of this rule represents the projected 
effects of the changes in hospice payments from FY 2018 to FY 2019. 
Using the most recent data available at the time of rulemaking, in this 
case FY 2017 hospice claims data, we apply the current FY 2018 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 
2018 payments. Then, using the same FY 2017 data, we apply the FY 2019 
wage index and labor-related share values to simulate FY 2019 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.
    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive 
Order 13771 on Reducing Regulation and Controlling Regulatory Costs 
(January 30, 2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). We estimate that this rulemaking is ``economically significant'' 
as measured by the $100 million threshold, and hence also a major rule 
under the Congressional Review Act. Accordingly, we have prepared a RIA 
that, to the best of our ability presents the costs and benefits of the 
rulemaking.

C. Anticipated Effects

    The Regulatory Flexibility Act (RFA) requires agencies to analyze 
options for regulatory relief of small businesses if a rule has a 
significant impact on a substantial number of small entities. The great 
majority of hospitals and most other health care providers and 
suppliers are small entities by meeting the Small Business 
Administration (SBA) definition of a small business (in the service 
sector, having revenues of less than $7.5 million to $38.5 million in 
any 1 year), or being nonprofit organizations. For purposes of the RFA, 
we consider all hospices as small entities as that term is used in the 
RFA. HHS's practice in interpreting the RFA is to consider effects 
economically ``significant'' only if greater than 5 percent of 
providers reach a threshold of 3 to 5 percent or more of total revenue 
or total costs. The effect of the FY 2018 hospice payment update 
percentage results in an overall increase in estimated hospice payments 
of 1.8 percent, or $340 million. Therefore, the

[[Page 38653]]

Secretary has determined that this rule will not create a significant 
economic impact on a substantial number of small entities.
    In addition, section 1102(b) of the Social Security Act requires us 
to prepare a regulatory impact analysis if a rule may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of 
section 604 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a metropolitan statistical area and has fewer than 100 beds. This rule 
will only affect hospices. Therefore, the Secretary has determined that 
this rule will not have a significant impact on the operations of a 
substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. The 2018 UMRA 
threshold is $150 million. This rule is not anticipated to have an 
effect on state, local, or tribal governments, in the aggregate, or on 
the private sector of $150 million or more.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on state 
and local governments, preempts state law, or otherwise has Federalism 
implications. We have reviewed this rule under these criteria of 
Executive Order 13132, and have determined that it will not impose 
substantial direct costs on state or local governments.
    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this final rule, we 
should estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review the rule, we assume that the total number of unique 
commenters on the published proposed rule will be the number of 
reviewers of this final rule. We acknowledge that this assumption may 
understate or overstate the costs of reviewing this final rule. It is 
possible that not all commenters reviewed the proposed rule in detail, 
and it is also possible that some reviewers chose not to comment on the 
proposed rule. For these reasons we thought that the number of comments 
received on the proposed rule would be a fair estimate of the number of 
reviewers of this final rule.
    Using the wage information from the Bureau of Labor Statistics 
(BLS) for medical and health service managers (Code 11-9111), we 
estimate that the cost of reviewing this rule is $107.38 per hour, 
including overhead and fringe benefits (https://www.bls.gov/oes/current/oes_nat.htm). Assuming an average reading speed of 250 words 
per minute, we estimate that it would take approximately 1 hour for the 
staff to review half of this rule which consists of approximately 
30,000 words. For each hospice that reviews the rule, the estimated 
cost is $107.38 (1 hour x $107.38). Therefore, we estimate that the 
total cost of reviewing this regulation is $9,664.20 ($107.38 x 90 
reviewers).

D. Detailed Economic Analysis

    The FY 2019 hospice payment impacts appear in Table 12. We tabulate 
the resulting payments according to the classifications in Table 12 
(for example, facility type, geographic region, facility ownership), 
and compare the difference between current and future payments to 
determine the overall impact.
    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 2019 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 2019 hospice wage index.
    The fourth column shows the effect of the hospice payment update 
percentage for FY 2019. The 1.8 percent hospice payment update 
percentage is based on the 2.9 percent inpatient hospital market basket 
update, reduced by a 0.8 percentage point productivity adjustment and 
by a 0.3 percentage point adjustment as required by statute, and is 
constant for all providers.
    The fifth column shows the effect of all the changes on FY 2019 
hospice payments. It is projected that aggregate payments would 
increase by 1.8 percent, assuming hospices do not change their service 
and billing practices.
    As illustrated in Table 12, the combined effects of all the 
proposals vary by specific types of providers and by location.

                                    Table 12--Impact to Hospices for FY 2019
----------------------------------------------------------------------------------------------------------------
                                                                               FY 2019 hospice
                                              Number of       Updated wage     payment update     FY 2019 total
                                              providers         data (%)             (%)           change (%)
----------------------------------------------------------------------------------------------------------------
All Hospices............................             4,440               0.0               1.8               1.8
Urban Hospices..........................             3,550               0.0               1.8               1.8
Rural Hospices..........................               890               0.1               1.8               1.9
Urban Hospices--New England.............               127               0.0               1.8               1.8
Urban Hospices--Middle Atlantic.........               250               0.0               1.8               1.8
Urban Hospices--South Atlantic..........               443              -0.1               1.8               1.7
Urban Hospices--East North Central......               399              -0.1               1.8               1.7
Urban Hospices--East South Central......               149               0.0               1.8               1.8
Urban Hospices--West North Central......               242               0.2               1.8               2.0
Urban Hospices--West South Central......               695               0.4               1.8               2.2
Urban Hospices--Mountain................               359              -0.3               1.8               1.5
Urban Hospices--Pacific.................               845               0.1               1.8               1.9
Urban Hospices--Outlying................                41               0.4               1.8               2.2
Rural Hospices--New England.............                27               1.6               1.8               3.4
Rural Hospices--Middle Atlantic.........                35               0.0               1.8               1.8
Rural Hospices--South Atlantic..........               108               0.0               1.8               1.8

[[Page 38654]]

 
Rural Hospices--East North Central......               138              -0.1               1.8               1.7
Rural Hospices--East South Central......               111               0.0               1.8               1.8
Rural Hospices--West North Central......               168               0.3               1.8               2.1
Rural Hospices--West South Central......               168               0.1               1.8               1.9
Rural Hospices--Mountain................                93              -0.4               1.8               1.4
Rural Hospices--Pacific.................                42               0.1               1.8               1.9
Rural Hospices--Outlying................                 6              -0.3               1.8               1.5
0-3,499 RHC Days (Small)................               999               0.2               1.8               2.0
3,500-19,999 RHC Days (Medium)..........             2,044               0.1               1.8               1.9
20,000+ RHC Days (Large)................             1,397               0.0               1.8               1.8
Non-Profit Ownership....................             1,028               0.0               1.8               1.8
For Profit Ownership....................             2,858               0.0               1.8               1.8
Government Ownership....................               141               0.2               1.8               2.0
Other Ownership.........................               413              -0.1               1.8               1.7
Freestanding Facility Type..............             3,638               0.0               1.8               1.8
HHA/Facility-Based Facility Type........               802              -0.1               1.8               1.7
----------------------------------------------------------------------------------------------------------------
Source: FY 2017 hospice claims from the Chronic Conditions Data Warehouse (CCW) Research Identifiable Files
  (RIFs) as of May 29, 2018.
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.

E. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Table 13, we have 
prepared an accounting statement showing the classification of the 
expenditures associated with the provisions of this final rule. Table 
13 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 4,440 hospices in 
our impact analysis file, which was constructed using FY 2017 claims 
available in May 2018. All expenditures are classified as transfers to 
hospices.

  Table 13--Accounting Statement: Classification of Estimated Transfers
                   and Costs, From FY 2018 to FY 2019
------------------------------------------------------------------------
                 Category                             Transfers
------------------------------------------------------------------------
Annualized Monetized Transfers............  $340 million \*\
From Whom to Whom?........................  Federal Government to
                                             Medicare Hospices.
------------------------------------------------------------------------
* The net increase of $340 million in transfer payments is a result of
  the 1.8 percent hospice payment update compared to payments in FY
  2018.

F. Regulatory Reform Analysis Under E.O. 13771

    Executive Order 13771, entitled ``Reducing Regulation and 
Controlling Regulatory Costs,'' was issued on January 30, 2017 (82 FR 
9339, February 3, 2017) and requires that the costs associated with 
significant new regulations ``shall, to the extent permitted by law, be 
offset by the elimination of existing costs associated with at least 
two prior regulations.'' It has been determined that this rule is an 
action that primarily results in transfers and does not impose more 
than de minimis costs as described above and thus is not a regulatory 
or deregulatory action for the purposes of Executive Order 13771.

G. Conclusion

    We estimate that aggregate payments to hospices in FY 2019 will 
increase by $340 million, or 1.8 percent, compared to payments in FY 
2018. We estimate that in FY 2019, hospices in urban and rural areas 
will experience, on average, 1.8 percent and 1.9 percent increases, 
respectively, in estimated payments compared to FY 2018. Hospices 
providing services in the urban West South Central and Outlying regions 
and the rural New England region would experience the largest estimated 
increases in payments of 2.2 percent and 3.4 percent, respectively. 
Hospices serving patients in rural areas in the Mountain region would 
experience, on average, the lowest estimated increase of 1.4 percent in 
FY 2019 payments.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 418

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

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 418--HOSPICE CARE

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

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


0
2. Section 418.3 is amended--
0
a. In the definition of ``Attending physician'', by revising paragraph 
(1); and
0
b. By revising the definition of ``Cap period''.
    The revisions read as follows:


Sec.  418.3   Definitions.

* * * * *
    Attending physician * * *
    (1)(i) Doctor of medicine or osteopathy legally authorized to 
practice medicine and surgery by the State in which he or she performs 
that function or action; or

[[Page 38655]]

    (ii) Nurse practitioner who meets the training, education, and 
experience requirements as described in Sec.  410.75(b) of this 
chapter; or
    (iii) Physician assistant who meets the requirements of Sec.  
410.74(c) of this chapter.
* * * * *
    Cap period means the twelve-month period ending September 30 used 
in the application of the cap on overall hospice reimbursement 
specified in Sec.  418.309.
* * * * *

0
3. Section 418.304 is amended by revising the section heading and 
adding paragraph (f) to read as follows:


Sec.  418.304   Payment for physician, and nurse practitioner, and 
physician assistant services.

* * * * *
    (f)(1) Effective January 1, 2019, Medicare pays for attending 
physician services provided by physician assistants to Medicare 
beneficiaries who have elected the hospice benefit and who have 
selected a physician assistant as their attending physician. This 
applies to physician assistants without regard to whether they are 
hospice employees.
    (2) The employer or a contractor of a physician assistant must bill 
and receive payment for physician assistant services only if the--
    (i) Physician assistant is the beneficiary's attending physician as 
defined in Sec.  418.3;
    (ii) Services are medically reasonable and necessary;
    (iii) Services are performed by a physician in the absence of the 
physician assistant and, the physician assistant services are furnished 
under the general supervision of a physician; and
    (iv) Services are not related to the certification of terminal 
illness specified in Sec.  418.22.
    (3) The payment amount for physician assistant services when 
serving as the attending physician for hospice patients is 85 percent 
of what a physician is paid under the Medicare physician fee schedule.

0
4. Section 418.309 is amended by revising paragraph (b)(1) to read as 
follows:


Sec.  418.309   Hospice aggregate cap.

* * * * *
    (b) * * *
    (1) In the case in which a beneficiary received care from only one 
hospice, the hospice includes in its number of Medicare beneficiaries 
those Medicare beneficiaries who have not previously been included in 
the calculation of any hospice cap, and who have filed an election to 
receive hospice care in accordance with Sec.  418.24 during the cap 
period as defined in Sec.  418.3, using the best data available at the 
time of the calculation.
* * * * *

    Dated: July 26, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: July 26, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-16539 Filed 8-1-18; 4:15 pm]
 BILLING CODE 4120-01-P