Medicare Program; FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 418

[CMS-1652-F]

RIN 0938-AS79

Medicare Program; FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements

AGENCY:

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

ACTION:

Final rule.

SUMMARY:

This final rule will update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2017. In addition, this rule changes the hospice quality reporting program, including adopting new quality measures. Finally, this final rule includes information regarding the Medicare Care Choices Model (MCCM).

DATES:

These regulations are effective on October 1, 2016.

FOR FURTHER INFORMATION CONTACT:

Debra Dean-Whittaker, (410) 786-0848 for questions regarding the CAHPS® Hospice Survey.

Michelle Brazil, (410) 786-1648 for questions regarding the hospice quality reporting program.

Hillary A. Loeffler, (410) 786-0456 for questions regarding hospice payment policy.

SUPPLEMENTARY INFORMATION:

Wage index addenda will be available only through the internet on the CMS Web site at: (

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/index.html.

)

Table of Contents

I. Executive Summary

A. Purpose

B. Summary of the Major Provisions

C. Summary of Impacts

II. Background

A. Hospice Care

B. History of the Medicare Hospice Benefit

C. Services Covered by the Medicare Hospice Benefit

D. Medicare Payment for Hospice Care

1. Omnibus Budget Reconciliation Act of 1989

2. Balanced Budget Act of 1997

3. FY 1998 Hospice Wage Index Final Rule

4. FY 2010 Hospice Wage Index Final Rule

5. The Affordable Care Act

6. FY 2012 Hospice Wage Index Final Rule

7. FY 2015 Hospice Wage Index and Payment Rate Update Final Rule

8. Impact Act of 2014

9. FY 2016 Hospice Wage Index and Payment Rate Update Final Rule

E. Trends in Medicare Hospice Utilization

F. Use of Health Information Technology

III. Provisions of the Final Rule

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

B. FY 2017 Hospice Wage Index and Rates Update

1. FY 2017 Hospice Wage Index

a. Background

b. FY 2016 Implementation of New Labor Market Delineations

2. FY 2017 Hospice Payment Update Percentage

3. FY 2017 Hospice Payment Rates

4. Hospice Cap Amount for FY 2017

C. Updates to the Hospice Quality Reporting Program

1. Background and Statutory Authority

2. General Considerations Used for Selection of Quality Measures for the HQRP

3. Policy for Retention of HQRP Measures Adopted for Previous Payment Determination

4. Previously Adopted Quality Measures for FY 2017 and FY 2018 Payment Determination

5. Proposed Removal of Previously Adopted Measures

6. Proposed New Quality Measures for FY 2019 Payment Determinations and Subsequent Years and Concepts Under Consideration for Future Years

a. Background and Considerations in Developing New Quality Measures for the HQRP

b. New Quality Measures for the FY 2019 Payment Determination and Subsequent Years

7. Form, Manner, and Timing of Quality Data Submission

a. Background

b. Previously Finalized Policy for New Facilities To Begin Submitting Quality Data

c. Previously Finalized Data Submission Mechanism, Collection Timelines, and Submission Deadlines for the FY 2017 Payment Determination

d. Previously Finalized Data Submission Timelines and Requirements for FY 2018 Payment Determination and Subsequent Years

e. Previously Finalized HQRP Data Submission and Compliance Thresholds for the FY 2018 Payment Determination and Subsequent Years

f. New Data Collection and Submission Mechanisms Under Consideration for Future Years

8. HQRP Submission Exemption and Extension Requirements for the FY 2017 Payment Determination and Subsequent Years

9. Hospice CAHPS® Participation Requirements for the 2019 APU and 2020 APU

a. Background Description of the Survey

b. Participation Requirements To Meet Quality Reporting Requirements for the FY 2019 APU

c. Participation Requirements To Meet Quality Reporting Requirements for the FY 2020 APU

d. Annual Payment Update

e. Hospice CAHPS® Reconsiderations and Appeals Process

10. HQRP Reconsideration and Appeals Procedures for the FY 2017 Payment Determination and Subsequent Years

11. Public Display of Quality Measures and Other Hospice Data for the HQRP

D. The Medicare Care Choices Model

IV. Collection of Information Requirements

V. Economic Analyses

VI. Federalism Analysis and Regulations Text

Acronyms

Because of the many terms to which we refer by acronym in this final rule, we are listing the acronyms used and their corresponding meanings in alphabetical order:

APU Annual Payment Update

ASPE Assistant Secretary of Planning and Evaluation

BBA Balanced Budget Act of 1997

BIPA Benefits Improvement and Protection Act of 2000

BNAF Budget Neutrality Adjustment Factor

BLS Bureau of Labor Statistics

CAHPS® Consumer Assessment of Healthcare Providers and Systems

CBSA Core-Based Statistical Area

CCN CMS Certification Number

CCW Chronic Conditions Data Warehouse

CFR Code of Federal Regulations

CHC Continuous Home Care

CHF Congestive Heart Failure

CMMI Center for Medicare & Medicaid Innovation

CMS Centers for Medicare & Medicaid Services

COPD Chronic Obstructive Pulmonary Disease

CoPs Conditions of Participation

CPI Center for Program Integrity

CPI-U Consumer Price Index—Urban Consumers

CR Change Request

CVA Cerebral Vascular Accident

CWF Common Working File

CY Calendar Year

DME Durable Medical Equipment

DRG Diagnostic Related Group

ER Emergency Room

FEHC Family Evaluation of Hospice Care

FR Federal Register

FY Fiscal Year

GAO Government Accountability Office

GIP General Inpatient Care

HCFA Healthcare Financing Administration

HHS Health and Human Services

HIPAA Health Insurance Portability and Accountability Act

HIS Hospice Item Set

HQRP Hospice Quality Reporting Program

IACS Individuals Authorized Access to CMS Computer Services

ICD-9-CM International Classification of Diseases, Ninth Revision, Clinical Modification

ICD-10-CM International Classification of Diseases, Tenth Revision, Clinical Modification

ICR Information Collection Requirement

IDG Interdisciplinary Group

IMPACT Act Improving Medicare Post-Acute Care Transformation Act of 2014

IOM Institute of Medicine

IPPS Inpatient Prospective Payment System

IRC Inpatient Respite Care

LCD Local Coverage Determination

LOS Length of Stay

MAC Medicare Administrative Contractor

MAP Measure Applications Partnership

MCCM Medicare Care Choices Model

MedPAC Medicare Payment Advisory Commission

MFP Multifactor Productivity

MSA Metropolitan Statistical Area

MSS Medical Social Services

NHPCO National Hospice and Palliative Care Organization

NF Long Term Care Nursing Facility

NOE Notice of Election

NOTR Notice of Termination/Revocation

NP Nurse Practitioner

NPI National Provider Identifier

NQF National Quality Forum

OIG Office of the Inspector General

OACT Office of the Actuary

OMB Office of Management and Budget

PEPPER Program for Evaluating Payment Patterns Electronic Report

PRRB Provider Reimbursement Review Board

PS&R Provider Statistical and Reimbursement Report

Pub. L. Public Law

QAPI Quality Assessment and Performance Improvement

RHC Routine Home Care

RN Registered Nurse

SBA Small Business Administration

SEC Securities and Exchange Commission

SIA Service Intensity Add-on

SNF Skilled Nursing Facility

TEFRA Tax Equity and Fiscal Responsibility Act of 1982

TEP Technical Expert Panel

UHDDS Uniform Hospital Discharge Data Set

U.S.C. United States Code

I. Executive Summary

A. Purpose

This final rule updates the hospice payment rates for fiscal year (FY) 2017, as required under section 1814(i) of the Social Security Act (the Act). This rule also finalizes new quality measures and provides an update on the hospice quality reporting program (HQRP) consistent with the requirements of section 1814(i)(5) of the Act, as added by section 3004(c) of the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act (Pub. L. 111-152) (collectively, the Affordable Care Act). In accordance with section 1814(i)(5)(A) of the Act, starting in FY 2014, hospices that have failed to meet quality reporting requirements receive a 2 percentage point reduction to their payments. Finally, this final rule shares information on the Medicare Care Choices Model developed in accordance with the authorization under section 1115A of the Act for the Center for Medicare and Medicaid Innovation (CMMI) to test innovative payment and service models that have the potential to reduce Medicare, Medicaid, or Children's Health Insurance Program (CHIP) expenditures while maintaining or improving the quality of care.

B. Summary of the Major Provisions

In section III.B.1 of this rule, we update the hospice wage index with updated wage data and make the application of the updated wage data budget-neutral for all four levels of hospice care. In section III.B.2 we discuss the FY 2017 hospice payment update percentage of 2.1 percent. Sections III.B.3 and III.B.4 update the hospice payment rates and hospice cap amount for FY 2017 by the hospice payment update percentage discussed in section III.B.2.

In section III.C of this rule, we discuss updates to HQRP, including two new quality measures as well as of the possibility of utilizing a new assessment instrument to collect quality data. As part of the HQRP, the new measures, effective April 1, 2017, will be: (1) Hospice Visits When Death is Imminent, assessing hospice staff visits to patients and caregivers in the last week of life; and (2) Hospice and Palliative Care Composite Process Measure, assessing the percentage of hospice patients who received care processes consistent with existing guidelines. In section III.C we will also discuss the enhancement of the current Hospice Item Set (HIS) data collection instrument to be more in line with other post-acute care settings. This new data collection instrument will be a comprehensive patient assessment instrument, rather than the current chart abstraction tool. Additionally, in this section we discuss our plans for sharing HQRP data publicly during calendar year (CY) 2016 as well as plans to provide public reporting via a Compare Site in CY 2017.

Finally, in section III.D, we are providing information regarding the Medicare Care Choices Model (MCCM). This model is testing a new option for Medicare and dual eligible beneficiaries with certain advanced diseases who meet the model's other eligibility criteria to receive hospice-like support services from MCCM participating hospices while receiving care from other Medicare providers for their terminal illness. This model is designed to: (1) Increase access to supportive care services provided by hospice; (2) improve quality of life and patient/family/caregiver satisfaction; and (3) inform new payment systems for the Medicare and Medicaid programs.

C. Summary of Impacts

Table 1—Impact Summary Table

Provision description

Transfers

FY 2017 Hospice Wage Index and Payment Rate Update

The overall economic impact of this final rule is estimated to be $350 million in increased payments to hospices during FY 2017.

II. Background

A. Hospice Care

Hospice care is an approach to treatment that recognizes that the impending death of an individual warrants a change in the focus from curative care to palliative care for relief of pain and for symptom management. The goal of hospice care is to help terminally ill individuals continue life with minimal disruption to normal activities while remaining primarily in the home environment. A hospice uses an interdisciplinary approach to deliver medical, nursing, social, psychological, emotional, and spiritual services through use of a broad spectrum of professionals and other caregivers, with the goal of making the beneficiary as physically and emotionally comfortable as possible. Hospice is compassionate beneficiary and family-centered care for those who are terminally ill. It is a comprehensive, holistic approach to treatment that recognizes that the impending death of an individual necessitates a transition from curative to palliative care.

Medicare regulations define “palliative care” as “patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and to facilitate patient autonomy, access to information, and choice.” (42 CFR 418.3) Palliative care is at the core of hospice philosophy and

care practices, and is a critical component of the Medicare hospice benefit. Also, see Hospice Conditions of Participation final rule (73 FR 32088 June 5, 2008). The goal of palliative care in hospice is to improve the quality of life of beneficiaries, and their families, facing the issues associated with a life-threatening illness through the prevention and relief of suffering by means of early identification, assessment, and treatment of pain and other issues that may arise. This is achieved by the hospice interdisciplinary group working with the beneficiary and family to develop a comprehensive care plan focused on coordinating care services, reducing unnecessary diagnostics, or ineffective therapies, and offering ongoing conversations with individuals and their families about changes in their condition. The beneficiary's comprehensive care plan will shift over time to meet the changing needs of the individual, family, and caregiver(s) as the individual approaches the end of life.

Medicare hospice care is palliative care for individuals with a prognosis of living 6 months or less if the terminal illness runs its normal course. When a beneficiary is terminally ill, many health problems are brought on by underlying condition(s), as bodily systems are interdependent. In the 2008 Hospice Conditions of Participation final rule, we stated that the medical director or physician designee must consider the primary terminal condition, related diagnoses, current subjective and objective medical findings, current medication and treatment orders, and information about unrelated conditions when considering the initial certification of the terminal illness. (73 FR 32176). As referenced in our regulations at § 418.22(b)(1), to be eligible for Medicare hospice services, the patient's attending physician (if any) and the hospice medical director must certify that the individual is “terminally ill,” as defined in section 1861(dd)(3)(A) of the Act and our regulations at § 418.3; that is, the individual's prognosis is for a life expectancy of 6 months or less if the terminal illness runs its normal course. The certification of terminal illness must include a brief narrative explanation of the clinical findings that supports a life expectancy of 6 months or less as part of the certification and recertification forms, as set out at § 418.22(b)(3).

While the goal of hospice care is to allow the beneficiary to remain in his or her home environment, circumstances during the end-of-life may necessitate short-term inpatient admission to a hospital, skilled nursing facility (SNF), or hospice facility for treatment necessary for pain control or acute or chronic symptom management that cannot be managed in any other setting. These acute hospice care services are to ensure that any new or worsening symptoms are intensively addressed so that the beneficiary can return to his or her home environment. Limited, short-term, intermittent, inpatient respite services are also available to the family/caregiver of the hospice patient to relieve the family or other caregivers. Additionally, an individual can receive continuous home care during a period of crisis in which an individual requires primarily continuous nursing care to achieve palliation or management of acute medical symptoms so that the individual can remain at home. Continuous home care may be covered on a continuous basis for as much as 24 hours a day, and these periods must be predominantly nursing care, in accordance with our regulations at § 418.204. A minimum of 8 hours of nursing care, or nursing and aide care, must be furnished on a particular day to qualify for the continuous home care rate (§ 418.302(e)(4)).

Hospices are expected to comply with all civil rights laws, including the provision of auxiliary aids and services to ensure effective communication with patients and patient care representatives with disabilities consistent with section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Act, and to provide language access for such persons who are limited in English proficiency, consistent with Title VI of the Civil Rights Act of 1964. Further information about these requirements may be found at

http://www.hhs.gov/civil-rights.

B. History of the Medicare Hospice Benefit

Before the creation of the Medicare hospice benefit, hospice programs were originally operated by volunteers who cared for the dying. During the early development stages of the Medicare hospice benefit, hospice advocates were clear that they wanted a Medicare benefit that provided all-inclusive care for terminally-ill individuals, provided pain relief and symptom management, and offered the opportunity to die with dignity in the comfort of one's home rather than in an institutional setting.

1

As stated in the August 22, 1983 proposed rule titled “Medicare Program; Hospice Care” (48 FR 38146), “the hospice experience in the United States has placed emphasis on home care. It offers physician services, specialized nursing services, and other forms of care in the home to enable the terminally ill individual to remain at home in the company of family and friends as long as possible.” The concept of a beneficiary “electing” the hospice benefit and being certified as terminally ill were two key components of the legislation responsible for the creation of the Medicare Hospice Benefit (section 122 of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA), (Pub. L. 97-248)). Section 122 of TEFRA created the Medicare Hospice benefit, which was implemented on November 1, 1983. Under sections 1812(d) and 1861(dd) of the Act, we provide coverage of hospice care for terminally ill Medicare beneficiaries who elect to receive care from a Medicare-certified hospice. Our regulations at § 418.54(c) stipulate that the comprehensive hospice assessment must identify the beneficiary's physical, psychosocial, emotional, and spiritual needs related to the terminal illness and related conditions, and address those needs in order to promote the beneficiary's well-being, comfort, and dignity throughout the dying process. The comprehensive assessment must take into consideration the following factors: The nature and condition causing admission (including the presence or lack of objective data and subjective complaints); complications and risk factors that affect care planning; functional status; imminence of death; and severity of symptoms (§ 418.54(c)). The Medicare hospice benefit requires the hospice to cover all reasonable and necessary palliative care related to the terminal prognosis, as described in the beneficiary's plan of care. The December 16, 1983 Hospice final rule (48 FR 56008) requires hospices to cover care for interventions to manage pain and symptoms. Additionally, the hospice Conditions of Participation (CoPs) at § 418.56(c) require that the hospice must provide all reasonable and necessary services for the palliation and management of the terminal illness, related conditions, and interventions to manage pain and symptoms. Therapy and interventions must be assessed and managed in terms of providing palliation and comfort without undue symptom burden for the hospice patient or family.

2

In the December 16, 1983 Hospice final rule (48 FR 56010), regarding what is related versus

unrelated to the terminal illness, we stated: “. . . we believe that the unique physical condition of each terminally ill individual makes it necessary for these decisions to be made on a case by case basis. It is our general view that hospices are required to provide virtually all the care that is needed by terminally ill patients.” Therefore, unless there is clear evidence that a condition is unrelated to the terminal prognosis, all conditions are considered to be related to the terminal prognosis and the responsibility of the hospice to address and treat.

1

Connor, Stephen. (2007). Development of Hospice and Palliative Care in the United States. OMEGA. 56(1), p. 89-99.

2

Paolini, DO, Charlotte. (2001). Symptoms Management at End of Life. JAOA. 101(10). p. 609-615.

As stated in the December 16, 1983 Hospice final rule, the fundamental premise upon which the hospice benefit was designed was the “revocation” of traditional curative care and the “election” of hospice care for end-of-life symptom management and maximization of quality of life (48 FR 56008). After electing hospice care, the beneficiary typically returns to the home from an institutionalized setting or remains in the home, to be surrounded by family and friends, and to prepare emotionally and spiritually, if requested, for death while receiving expert symptom management and other supportive services. Election of hospice care also requires waiving the right to Medicare payment for curative treatment for the terminal prognosis, and instead receiving palliative care to manage pain or other symptoms.

The benefit was originally designed to cover hospice care for a finite period of time that roughly corresponded to a life expectancy of 6 months or less. Initially, beneficiaries could receive three election periods: Two 90-day periods and one 30-day period. Currently, Medicare beneficiaries can elect hospice care for two 90-day periods and an unlimited number of subsequent 60-day periods; however, at the beginning of each period, a physician must certify that the beneficiary has a life expectancy of 6 months or less if the terminal illness runs its normal course.

C. Services Covered by the Medicare Hospice Benefit

One requirement for coverage under the Medicare Hospice benefit is that hospice services must be reasonable and necessary for the palliation and management of the terminal illness and related conditions. Section 1861(dd)(1) of the Act establishes the services that are to be rendered by a Medicare certified hospice program. These covered services include: Nursing care; physical therapy; occupational therapy; speech-language pathology therapy; medical social services; home health aide services (now called hospice aide services); physician services; homemaker services; medical supplies (including drugs and biologicals); medical appliances; counseling services (including dietary counseling); short-term inpatient care in a hospital, nursing facility, or hospice inpatient facility (including both respite care and procedures necessary for pain control and acute or chronic symptom management); continuous home care during periods of crisis, and only as necessary to maintain the terminally ill individual at home; and any other item or service which is specified in the plan of care and for which payment may otherwise be made under Medicare, in accordance with Title XVIII of the Act.

Section 1814(a)(7)(B) of the Act requires that a written plan for providing hospice care to a beneficiary who is a hospice patient be established before care is provided by, or under arrangements made by, that hospice program and that the written plan be periodically reviewed by the beneficiary's attending physician (if any), the hospice medical director, and an interdisciplinary group (described in section 1861(dd)(2)(B) of the Act). The services offered under the Medicare hospice benefit must be available to beneficiaries as needed, 24 hours a day, 7 days a week (section 1861(dd)(2)(A)(i) of the Act). Upon the implementation of the hospice benefit, Congress expected hospices to continue to use volunteer services, though these services are not reimbursed by Medicare (see section 1861(dd)(2)(E) of the Act and 48 FR 38149). As stated in the August 22, 1983 Hospice proposed rule, the hospice interdisciplinary group should comprise paid hospice employees as well as hospice volunteers (48 FR 38149). This expectation supports the hospice philosophy of holistic, comprehensive, compassionate, end-of-life care.

Before the Medicare hospice benefit was established, Congress requested a demonstration project to test the feasibility of covering hospice care under Medicare. The National Hospice Study was initiated in 1980 through a grant sponsored by the Robert Wood Johnson and John A. Hartford Foundations and the Centers for Medicare & Medicaid Services (CMS) (then, the Health Care Financing Administration (HCFA)). The demonstration project was conducted between October 1980 and March 1983. The project summarized the hospice care philosophy and principles as the following:

• Patient and family know of the terminal condition.

• Further medical treatment and intervention are indicated only on a supportive basis.

• Pain control should be available to patients as needed to prevent rather than to just ameliorate pain.

• Interdisciplinary teamwork is essential in caring for patient and family.

• Family members and friends should be active in providing support during the death and bereavement process.

• Trained volunteers should provide additional support as needed.

The cost data and the findings on what services hospices provided in the demonstration project were used to design the Medicare hospice benefit. The identified hospice services were incorporated into the service requirements under the Medicare hospice benefit. Importantly, in the August 22, 1983 Hospice proposed rule, we stated “the hospice benefit and the resulting Medicare reimbursement is not intended to diminish the voluntary spirit of hospices” (48 FR 38149).

D. Medicare Payment for Hospice Care

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

1. Omnibus Budget Reconciliation Act of 1989

Section 6005(a) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239) amended section 1814(i)(1)(C) of the Act and provided for the following two changes in the methodology concerning updating the daily payment rates: (1) Effective January 1, 1990, the daily payment rates for RHC and other services included in

hospice care were increased to equal 120 percent of the rates in effect on September 30, 1989; and (2) the daily payment rate for RHC and other services included in hospice care for fiscal years (FYs) beginning on or after October 1, 1990, were the payment rates in effect during the previous Federal FY increased by the hospital market basket percentage increase.

2. Balanced Budget Act of 1997

Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) amended section 1814(i)(1)(C)(ii)(VI) of the Act to establish updates to hospice rates for FYs 1998 through 2002. Hospice rates were updated by a factor equal to the hospital market basket percentage increase, minus 1 percentage point. Payment rates for FYs from 2002 have been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent FYs will be the hospital market basket percentage increase for the FY. The Act requires us to use the inpatient hospital market basket to determine hospice payment rates.

3. FY 1998 Hospice Wage Index Final Rule

In the August 8, 1997 FY 1998 Hospice Wage Index final rule (62 FR 42860), we implemented a new methodology for calculating the hospice wage index based on the recommendations of a negotiated rulemaking committee. The original hospice wage index was based on 1981 Bureau of Labor Statistics hospital data and had not been updated since 1983. In 1994, because of disparity in wages from one geographical location to another, the Hospice Wage Index Negotiated Rulemaking Committee was formed to negotiate a new wage index methodology that could be accepted by the industry and the government. This Committee was composed of representatives from national hospice associations; rural, urban, large and small hospices, and multi-site hospices; consumer groups; and a government representative. The Committee decided that in updating the hospice wage index, aggregate Medicare payments to hospices would remain budget neutral to payments calculated using the 1983 wage index, to cushion the impact of using a new wage index methodology. To implement this policy, a Budget Neutrality Adjustment Factor (BNAF) was computed and applied annually to the pre-floor, pre-reclassified hospital wage index when deriving the hospice wage index, subject to a wage index floor.

4. FY 2010 Hospice Wage Index Final Rule

Inpatient hospital pre-floor and pre-reclassified wage index values, as described in the August 8, 1997 Hospice Wage Index final rule, are subject to either a budget neutrality adjustment or application of the wage index floor. Wage index values of 0.8 or greater are adjusted by the BNAF. Starting in FY 2010, a 7-year phase-out of the BNAF began (FY 2010 Hospice Wage Index final rule, (74 FR 39384, August 6, 2009)), with a 10 percent reduction in FY 2010, an additional 15 percent reduction for a total of 25 percent in FY 2011, an additional 15 percent reduction for a total 40 percent reduction in FY 2012, an additional 15 percent reduction for a total of 55 percent in FY 2013, and an additional 15 percent reduction for a total 70 percent reduction in FY 2014. The phase-out continued with an additional 15 percent reduction for a total reduction of 85 percent in FY 2015, an additional, and final, 15 percent reduction for complete elimination in FY 2016. We note that the BNAF was an adjustment which increased the hospice wage index value. Therefore, the BNAF phase-out reduced the amount of the BNAF increase applied to the hospice wage index value. It was not a reduction in the hospice wage index value itself or in the hospice payment rates.

5. The Affordable Care Act

Starting with FY 2013 (and in subsequent FYs), the market basket percentage update under the hospice payment system referenced in sections 1814(i)(1)(C)(ii)(VII) and 1814(i)(1)(C)(iii) of the Act is subject to annual reductions related to changes in economy-wide productivity, as specified in section 1814(i)(1)(C)(iv) of the Act. In FY 2013 through FY 2019, the market basket percentage update under the hospice payment system will be reduced by an additional 0.3 percentage point (although for FY 2014 to FY 2019, the potential 0.3 percentage point reduction is subject to suspension under conditions specified in section 1814(i)(1)(C)(v) of the Act).

In addition, sections 1814(i)(5)(A) through (C) of the Act, as added by section 3132(a) of the Affordable Care Act, require hospices to begin submitting quality data, based on measures to be specified by the Secretary of the Department of Health and Human Services (the Secretary), for FY 2014 and subsequent FYs. Beginning in FY 2014, hospices which fail to report quality data will have their market basket update reduced by 2 percentage points.

Section 1814(a)(7)(D)(i) of the Act, as added by section 3132(b)(2) of the Affordable Care Act, requires, effective January 1, 2011, that a hospice physician or nurse practitioner have a face-to-face encounter with the beneficiary to determine continued eligibility of the beneficiary's hospice care prior to the 180th-day recertification and each subsequent recertification, and to attest that such visit took place. When implementing this provision, we finalized in the CY 2011 Home Health Prospective Payment System final rule (75 FR 70435) that the 180th-day recertification and subsequent recertifications would correspond to the beneficiary's third or subsequent benefit periods. Further, section 1814(i)(6) of the Act, as added by section 3132(a)(1)(B) of the Affordable Care Act, authorizes the Secretary to collect additional data and information determined appropriate to revise payments for hospice care and other purposes. The types of data and information suggested in the Affordable Care Act could capture accurate resource utilization, which could be collected on claims, cost reports, and possibly other mechanisms, as the Secretary determined to be appropriate. The data collected could be used to revise the methodology for determining the payment rates for RHC and other services included in hospice care, no earlier than October 1, 2013, as described in section 1814(i)(6)(D) of the Act. In addition, we were required to consult with hospice programs and the Medicare Payment Advisory Commission (MedPAC) regarding additional data collection and payment revision options.

6. FY 2012 Hospice Wage Index Final Rule

When the Medicare Hospice benefit was implemented, Congress included an aggregate cap on hospice payments, which limits the total aggregate payments any individual hospice can receive in a year. Congress stipulated that a “cap amount” be computed each year. The cap amount was set at $6,500 per beneficiary when first enacted in 1983 and has been adjusted annually by the change in the medical care expenditure category of the consumer price index for urban consumers from March 1984 to March of the cap year (section 1814(i)(2)(B) of the Act). The cap year was defined as the period from November 1st to October 31st. In the August 4, 2011 FY 2012 Hospice Wage Index final rule (76 FR 47308 through 47314) for the 2012 cap year and

subsequent cap years, we announced that subsequently, the hospice aggregate cap would be calculated using the patient-by-patient proportional methodology. We allowed existing hospices the option of having their cap calculated via the original streamlined methodology. As of FY 2012, new hospices have their cap determinations calculated using the patient-by-patient proportional methodology. The patient-by-patient proportional methodology and the streamlined methodology are two different methodologies for counting beneficiaries when calculating the hospice aggregate cap. A detailed explanation of these methods is found in the August 4, 2011 FY 2012 Hospice Wage Index final rule (76 FR 47308 through 47314). If a hospice's total Medicare reimbursement for the cap year exceeds the hospice aggregate cap, then the hospice must repay the excess back to Medicare.

7. FY 2015 Hospice Wage Index and Payment Rate Update Final Rule

When electing hospice, a beneficiary waives Medicare coverage for any care for the terminal illness and related conditions except for services provided by the designated hospice and attending physician. The FY 2015 Hospice Wage Index and Payment Rate Update final rule (79 FR 50452) finalized a requirement that requires the Notice of Election (NOE) be filed within 5 calendar days after the effective date of hospice election. If the NOE is filed beyond this 5-day period, hospice providers are liable for the services furnished during the days from the effective date of hospice election to the date of NOE filing (79 FR 50474). Similar to the NOE, the claims processing system must be notified of a beneficiary's discharge from hospice or hospice benefit revocation. This update to the beneficiary's status allows claims from non-hospice providers to be processed and paid. Late filing of the NOE can result in inaccurate benefit period data and leaves Medicare vulnerable to paying non-hospice claims related to the terminal illness and related conditions and beneficiaries possibly liable for any cost-sharing associated costs. Upon live discharge or revocation, the beneficiary immediately resumes the Medicare coverage that had been waived when he or she elected hospice. The FY 2015 Hospice Wage Index and Payment Rate Update final rule also finalized a requirement that requires hospices to file a notice of termination/revocation within 5 calendar days of a beneficiary's live discharge or revocation, unless the hospices have already filed a final claim. This requirement helps to protect beneficiaries from delays in accessing needed care (§ 418.26(e)).

A hospice “attending physician” is described by the statutory and regulatory definitions as a medical doctor, osteopath, or nurse practitioner whom the beneficiary identifies, at the time of hospice election, as having the most significant role in the determination and delivery of his or her medical care. We received reports of problems with the identification of the person's designated attending physician and a third of hospice patients had multiple providers submit Part B claims as the “attending physician,” using a claim modifier. The FY 2015 Hospice Wage Index and Payment Rate Update final rule finalized a requirement that the election form include the beneficiary's choice of attending physician and that the beneficiary provide the hospice with a signed document when he or she chooses to change attending physicians (79 FR 50479).

Hospice providers are required to begin using a Hospice Experience of Care Survey for informal caregivers of hospice patients surveyed in 2015. The FY 2015 Hospice Wage Index and Payment Rate Update final rule provided background and a description of the development of the Hospice Experience of Care Survey, including the model of survey implementation, the survey respondents, eligibility criteria for the sample, and the languages in which the survey is offered. The FY 2015 Hospice Rate Update final rule also set out participation requirements for CY 2015 and discussed vendor oversight activities and the reconsideration and appeals process for entities that failed to win CMS approval as vendors (79 FR 50496).

Finally, the FY 2015 Hospice Wage Index and Payment Rate Update final rule required providers to complete their aggregate cap determination not sooner than 3 months after the end of the cap year, and not later than 5 months after, and remit any overpayments. Those hospices that fail to timely submit their aggregate cap determinations will have their payments suspended until the determination is completed and received by the Medicare Administrative Contractor (MAC) (79 FR 50503).

8. IMPACT Act of 2014

The Improving Medicare Post-Acute Care Transformation Act of 2014 (Pub. L. 113-185) (IMPACT Act) became law on October 6, 2014. Section 3(a) of the IMPACT Act mandated that all Medicare certified hospices be surveyed every 3 years beginning April 6, 2015 and ending September 30, 2025. In addition, section 3(c) of the IMPACT Act requires medical review of hospice cases involving beneficiaries receiving more than 180 days care in select hospices that show a preponderance of such patients; section 3(d) of the IMPACT Act contains a new provision mandating that the cap amount for accounting years that end after September 30, 2016, and before October 1, 2025 be updated by the hospice payment update rather than using the consumer price index for urban consumers (CPI-U) for medical care expenditures.

9. FY 2016 Hospice Wage Index and Payment Rate Update Final Rule

In the FY 2016 Hospice Rate Update final rule, we created two different payment rates for RHC that resulted in a higher base payment rate for the first 60 days of hospice care and a reduced base payment rate for all subsequent days of hospice care (80 FR 47172). We also created a Service Intensity Add-on (SIA) payment payable for services during the last 7 days of the beneficiary's life, equal to the CHC hourly payment rate multiplied by the amount of direct patient care provided by a registered nurse (RN) or social worker that occurs during the last 7 days (80 FR 47177).

In addition to the hospice payment reform changes discussed, the FY 2016 Hospice Wage Index and Payment Rate Update final rule implemented changes mandated by the IMPACT Act, in which the cap amount for accounting years that end after September 30, 2016 and before October 1, 2025 is updated by the hospice payment update percentage rather than using the CPI-U. This was applied to the 2016 cap year, starting on November 1, 2015 and ending on October 31, 2016. In addition, we finalized a provision to align the cap accounting year for both the inpatient cap and the hospice aggregate cap with the FY, for FY 2017 and later (80 FR 47186). This allows for the timely implementation of the IMPACT Act changes while better aligning the cap accounting year with the timeframe described in the IMPACT Act.

Finally, the FY 2016 Hospice Wage Index and Payment Rate Update final rule clarified that hospices must report all diagnoses of the beneficiary on the hospice claim as a part of the ongoing data collection efforts for possible future hospice payment refinements. Reporting of all diagnoses on the hospice claim aligns with current coding guidelines as

well as admission requirements for hospice certifications (80 FR 47142).

E. Trends in Medicare Hospice Utilization

Since the implementation of the hospice benefit in 1983, and especially within the last decade, there has been substantial growth in hospice benefit utilization. The number of Medicare beneficiaries receiving hospice services has grown from 513,000 in FY 2000 to nearly 1.4 million in FY 2015. Similarly, Medicare hospice expenditures have risen from $2.8 billion in FY 2000 to an estimated $15.5 billion in FY 2015.

3

Under the economic assumptions from the 2017 Mid-Session Review,

4

our Office of the Actuary (OACT) projects that hospice expenditures are expected to continue to increase, by approximately 7 percent annually, reflecting an increase in the number of Medicare beneficiaries, more beneficiary awareness of the Medicare Hospice Benefit for end-of-life care, and a growing preference for care provided in home and community-based settings.

3

FY2000 figures from MedPAC analysis of the denominator file, the Medicare Beneficiary Database, and the 100 percent hospice claims standard analytic file from CMS (

http://www.medpac.gov/documents/reports/chapter-11-hospice-services-(march-2012-report).pdf?sfvrsn=4

). FY 2015 hospice claims data from the Chronic Conditions Data Warehouse (CCW), accessed on June 20, 2016.

4

“Mid-Session Review: Budget of the US Government.”

Office of Management and Budget.

July 15, 2016.

https://www.whitehouse.gov/sites/default/files/omb/budget/fy2017/assets/17msr.pdf.

There have also been changes in the diagnosis patterns among Medicare hospice enrollees. Specifically, as described in Table 2, there have been notable increases between 2002 and 2015 in neurologically-based diagnoses, including various dementia and Alzheimer's diagnoses. Additionally, there had been significant increases in the use of non-specific, symptom-classified diagnoses, such as “debility” and “adult failure to thrive.” In FY 2013, “debility” and “adult failure to thrive” were the first and sixth most common hospice claims-reported diagnoses, respectively, accounting for approximately 14 percent of all diagnoses. Effective October 1, 2014, hospice claims are returned to the provider if “debility” and “adult failure to thrive” are coded as the principal hospice diagnosis as well as other ICD-9-CM (and as of October 1, 2015, ICD-10-CM) codes that are not permissible as principal diagnosis codes per ICD-9-CM (or ICD-10-CM) coding guidelines. In the FY 2015 Hospice Wage Index and Payment Rate Update final rule (79 FR 50452), we reminded the hospice industry that this policy would go into effect and claims would start to be returned to the provider effective October 1, 2014. As a result of this, there has been a shift in coding patterns on hospice claims. For FY 2015, the most common hospice principal diagnoses were Alzheimer's disease, Congestive Heart Failure, Lung Cancer, Chronic Airway Obstruction, and Senile Dementia which constituted approximately 35 percent of all claims-reported principal diagnosis codes reported in FY 2015. In Table 2 we have updated the information initially presented in the FY 2017 proposed rule (81 FR 25504-06).

Table 2—The Top Twenty Principal Hospice Diagnoses, FY 2002, FY 2007, FY 2013, FY 2015

Rank

ICD-9

Reported principal diagnosis

Count

Percentage

Year: FY 2002

1

162.9

Lung Cancer

73,769

11

2

428.0

Congestive Heart Failure

45,951

7

3

799.3

Debility Unspecified

36,999

6

4

496

COPD

35,197

5

5

331.0

Alzheimer's Disease

28,787

4

6

436

CVA/Stroke

26,897

4

7

185

Prostate Cancer

20,262

3

8

783.7

Adult Failure To Thrive

18,304

3

9

174.9

Breast Cancer

17,812

3

10

290.0

Senile Dementia, Uncomp

16,999

3

11

153.0

Colon Cancer

16,379

2

12

157.9

Pancreatic Cancer

15,427

2

13

294.8

Organic Brain Synd Nec

10,394

2

14

429.9

Heart Disease Unspecified

10,332

2

15

154.0

Rectosigmoid Colon Cancer

8,956

1

16

332.0

Parkinson's Disease

8,865

1

17

586

Renal Failure Unspecified

8,764

1

18

585

Chronic Renal Failure (End 2005)

8,599

1

19

183.0

Ovarian Cancer

7,432

1

20

188.9

Bladder Cancer

6,916

1

Year: FY 2007

1

799.3

Debility Unspecified

90,150

9

2

162.9

Lung Cancer

86,954

8

3

428.0

Congestive Heart Failure

77,836

7

4

496

COPD

60,815

6

5

783.7

Adult Failure To Thrive

58,303

6

6

331.0

Alzheimer's Disease

58,200

6

7

290.0

Senile Dementia Uncomp

37,667

4

8

436

CVA/Stroke

31,800

3

9

429.9

Heart Disease Unspecified

22,170

2

10

185

Prostate Cancer

22,086

2

11

174.9

Breast Cancer

20,378

2

12

157.9

Pancreas Unspecified

19,082

2

13

153.9

Colon Cancer

19,080

2

14

294.8

Organic Brain Syndrome NEC

17,697

2

15

332.0

Parkinson's Disease

16,524

2

16

294.10

Dementia In Other Diseases w/o Behav. Dist

15,777

2

17

586

Renal Failure Unspecified

12,188

1

18

585.6

End Stage Renal Disease

11,196

1

19

188.9

Bladder Cancer

8,806

1

20

183.0

Ovarian Cancer

8,434

1

Year: FY 2013

1

799.3

Debility Unspecified

127,415

9

2

428.0

Congestive Heart Failure

96,171

7

3

162.9

Lung Cancer

91,598

6

4

496

COPD

82,184

6

5

331.0

Alzheimer's Disease

79,626

6

6

783.7

Adult Failure to Thrive

71,122

5

7

290.0

Senile Dementia, Uncomp

60,579

4

8

429.9

Heart Disease Unspecified

36,914

3

9

436

CVA/Stroke

34,459

2

10

294.10

Dementia In Other Diseases w/o Behavioral Dist

30,963

2

11

332.0

Parkinson's Disease

25,396

2

12

153.9

Colon Cancer

23,228

2

13

294.20

Dementia Unspecified w/o Behavioral Dist

23,224

2

14

174.9

Breast Cancer

23,059

2

15

157.9

Pancreatic Cancer

22,341

2

16

185

Prostate Cancer

21,769

2

17

585.6

End-Stage Renal Disease

19,309

1

18

518.81

Acute Respiratory Failure

15,965

1

19

294.8

Other Persistent Mental Dis.-classified elsewhere

14,372

1

20

294.11

Dementia In Other Diseases w/Behavioral Dist

13,687

1

Year: FY 2015

1

331.0

Alzheimer's disease

196,705

13

2

428.0

Congestive heart failure, unspecified

115,111

8

3

162.9

Lung Cancer

88,404

6

4

496

COPD

80,655

6

5

331.2

Senile degeneration of brain

46,843

3

6

332.0

Parkinson's Disease

34,957

2

7

429.9

Heart disease, unspecified

31,906

2

8

436

CVA/Stroke

29,172

2

9

437.0

Cerebral atherosclerosis

26,887

2

10

174.9

Breast Cancer

23,969

2

11

153.9

Colon Cancer

23,844

2

12

185

Prostate Cancer

23,293

2

13

157.9

Pancreatic Cancer

23,127

2

14

585.6

End stage renal disease

22,990

2

15

491.21

Obstructive chronic bronchitis with (acute) exacerbation

21,493

1

16

518.81

Acute respiratory failure

20,214

1

17

429.2

Cardiovascular disease, unspecified

16,937

1

18

434.91

Cerebral artery occlusion, unspecified with cerebral infarction

15,841

1

19

414.00

Coronary atherosclerosis of unspecified type of vessel

15,689

1

20

188.9

Bladder Cancer

11,648

1

Note(s):

The frequencies shown represent beneficiaries that had a least one claim with the specific ICD-9-CM code reported as the principal diagnosis. Beneficiaries could be represented multiple times in the results if they have multiple claims during that time period with different principal diagnoses.

Source: FY 2002 and 2007 hospice claims data from the Chronic Conditions Data Warehouse (CCW), accessed on February 14 and February 20, 2013. FY 2013 hospice claims data from the CCW, accessed on June 26, 2014, and FY 2015 hospice claims data from the CCW, accessed on June 20, 2016.

While there has been a shift in the reporting of the principal diagnosis as a result of diagnosis clarifications, a significant proportion of hospice claims (49 percent) in FY 2014 only reported a single principal diagnosis, which may not fully explain the characteristics of Medicare beneficiaries who are approaching the end of life. To address this pattern of single diagnosis reporting, the FY 2015 Hospice Wage Index and Payment Rate Update final rule (79 FR 50498) reiterated ICD-9-CM coding guidelines for the reporting of the principal and additional diagnoses on the hospice claim. We reminded providers to report all diagnoses on the hospice claim for the terminal illness and related conditions, including those that affect the care and clinical management for the beneficiary. Additionally, in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47201), we provided further clarification regarding diagnosis reporting on hospice claims. We clarified that hospices will report

all

diagnoses identified in the initial and comprehensive assessments on hospice claims, whether related or unrelated to the terminal prognosis of the individual, effective October 1, 2015. Analysis of FY 2015 hospice claims show that only 37 percent of hospice claims include a single, principal diagnosis, with 63 percent submitting at least two diagnoses and 46 percent including at least three.

F. Use of Health Information Technology

The Department of Health and Human Services (HHS) believes that the use of certified health IT by hospices can help providers improve internal care delivery practices and advance the interoperable exchange of health information across care partners to improve communication and care coordination. HHS has a number of initiatives designed to encourage and support the adoption of health information technology and promote nationwide health information exchange to improve health care. The Office of the National Coordinator for Health Information Technology (ONC) leads these efforts in collaboration with other agencies, including CMS and the Office of the Assistant Secretary for Planning and Evaluation (ASPE). In 2015, ONC released a document entitled “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap” (available at:

https://www.healthit.gov/sites/default/files/hie-interoperability/nationwide-interoperability-roadmap-final-version-1.0.pdf

), which includes a near-term focus on actions that will enable a majority of individuals and providers across the care continuum to send, receive, find and use a common set of electronic clinical information at the nationwide level by the end of 2017. The 2015 Edition Health IT Certification Criteria (2015 Edition) builds on past rulemakings to facilitate greater interoperability for several clinical health information purposes and enables health information exchange through new and enhanced certification criteria, standards, and implementation specifications. The 2015 Edition also focuses on the establishment of an interoperable nationwide health information infrastructure. More information on the 2015 Edition Final Rule is available at:

https://www.healthit.gov/policy-researchers-implementers/2015-edition-final-rule

III. Provisions of the Proposed Regulations

The proposed rule, titled “Medicare Program; FY 2017 Hospice Payment Rate Update” (81 FR 25497 through 25538), was published in the

Federal Register

on April 28, 2016, with a comment period that ended on June 20, 2016. In that proposed rule, we proposed to update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2017. In addition, the proposed rule proposed changes to the hospice quality reporting program, including new quality measures. The proposed rule also solicited feedback on an enhanced data collection instrument and described plans to publicly display quality measures and other hospice data beginning in the middle of 2017. Finally, the proposed rule included information regarding the Medicare Care Choices Model (MCCM). We received approximately 56 public comments on the proposed rule, including comments from MedPAC, hospice agencies, national provider associations, patient organizations, nurses, and advocacy groups.

In this final rule, we provide a summary of each proposed provision, a summary of the public comments received and our responses to them, and the policies we are finalizing for the FY 2017 Hospice Payment Rate Update. Comments related to the paperwork burden are addressed in the “Collection of Information Requirements” section in this final rule. Comments related to the impact analysis are addressed in the “Economic Analyses” section in this final rule.

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

In the FY 2017 Hospice Wage Index and Rate Update proposed rule (81 FR 25497), we provided a summary of analysis conducted on pre-hospice spending, non-hospice spending, live discharge rates, and skilled visits in the last days of life. In addition, we also provided a summary of our plans to monitor for impacts of hospice payment reform. We will continue to monitor the impact of future payment and policy changes and will provide the industry with periodic updates on our analysis in future rulemaking and/or announcements on the Hospice Center Web page at:

https://www.cms.gov/Center/Provider-Type/Hospice-Center.html.

We received several comments on the analysis and CMS's plans for future monitoring efforts with regards to hospice payment reform outlined in the proposed rule, which are summarized below.

Comment:

A few commenters expressed concerns regarding whether pre-hospice spending is an appropriate standard for comparison for post-hospice spending for any diagnosis, including dementia. The commenters noted the illness trajectory of dementia is marked by a slow, progressive decline, differs from the illness trajectories of other hospice appropriate diagnoses, and results in care needs increasing and extending over longer periods of time. In turn, it may require higher spending. The commenters asked us to recognize the overall care needs of patients with dementia and other progressive neurological conditions, and the costs associated with these patients and their caregivers. Additionally, several commenters highlighted the challenges of and intensive resources required for short-stay patients, noting that the current payment system may not address the unique needs of that population.

Several commenters suggested that CMS consider payment refinements that help to incentivize appropriate timing on enrollment for hospice. Additional commenters noted their concern regarding a potential case-mix payment system for hospice, as the commenters believe that the hospice benefit differs from all other Medicare payment systems, as it is designed to account for the patient's full scope of Medicare needs.

With regards to non-hospice spending during a hospice election, several commenters suggested that CMS take action to educate other Medicare provider types in order to increase understanding of benefits coverage and claims processing after a beneficiary has elected hospice. Several commenters also suggested that CMS investigate options for preventing other Medicare providers from billing without checking the Common Working File and notifying the hospice for a determination as to whether or not the care is related to the terminal prognosis. Several commenters requested that a greater level of specificity for Part D data be supplied to hospice providers, such that they can track where the billing issues originate and begin to address them. The commenters suggested that a coordinated system would help address the non-hospice spending.

With regards to hospice live discharge rates, a few commenters noted concerns about the difference between two types of live discharges: A patient-initiated discharge or revocation versus a hospice-initiated discharge. The commenters suggested that analysis of live discharge rates should exclude the patient-initiated discharges or revocations. Commenters suggested that for hospice-initiated discharges, the reasons for such discharges should be reported so that hospice providers can

make adjustments in their admission and discharge practices.

With regards to skilled visits during the last days of life, the number of visits by RNs and social workers is anticipated to increase during the last 7 days of a beneficiary's life as a result of the service intensity add‐on payment, implemented on January 1, 2016. A few commenters stated that hospices take their cues from patients and families, who should always have the option to decline a visit. As such, decisions regarding visits made by the patient and family ought to be considered and/or reflected in the data.

Finally, most commenters supported our planned analysis to monitor the impact of hospice payment reform and would like to use the monitoring results to target program integrity efforts to those aberrant individual providers.

Although the analysis and monitoring efforts described in the proposed rule did not relate to the timely filing requirement for the hospice Notice of Election (NOE), nevertheless a few commenters expressed concern about the timely filing requirement and lost revenue due to data entry errors that cannot be immediately corrected. Commenters encouraged CMS to continue to explore the possibility of transmitting NOEs through Electronic Data Interchange rather than through direct data entry and recommended that, in the meantime, when the hospice files the NOE in good faith within the 5-day requirement, but the MAC does not accept the NOE within 5 days, the payment for hospice services should be allowed back to the date of election, once the MAC has accepted the NOE.

Response:

We appreciate these comments on the ongoing analysis presented and will continue to monitor hospice trends and vulnerabilities within the hospice benefit while also investigating means by which we can educate the larger provider community regarding appropriate billing practices. Additionally, we continue to explore options and strategies for addressing and responding to concerning behavior in the provider community. We will also consider these suggestions in any potential future policy and payment refinements.

With regards to the comments received regarding the NOE timely filing requirement, we recognize that inadvertent NOE errors, such as transposed numbers or incorrect admission dates, will not trigger the NOE to return to the hospice for correction. The hospice must wait until the incorrect information is fully processed by Medicare systems before they can correct it, and this could cause the NOE to be late. We strongly encourage hospices to have quality assurance measures in place regarding the accuracy of the NOE information to mitigate any potential untimely NOEs. Our expectation is that the information provided on the hospice NOE is accurate and free of transcribing errors. To aid in reducing the impact of these situations on hospices, CMS is currently conducting an analysis that aims to redesign the hospice benefit period data in our systems.

B. FY 2017 Hospice Wage Index and Rate Update

1. FY 2017 Hospice Wage Index

a. Background

The hospice wage index is used to adjust payment rates for hospice agencies under the Medicare program to reflect local differences in area wage levels, based on the location where services are furnished. The hospice wage index utilizes the wage adjustment factors used by the Secretary for purposes of section 1886(d)(3)(E) of the Act for hospital wage adjustments. Our regulations at § 418.306(c) require each labor market to be established using the most current hospital wage data available, including any changes made by the Office of Management and Budget (OMB) to the Metropolitan Statistical Areas (MSAs) definitions.

We use the previous FY's hospital wage index data to calculate the hospice wage index values. For FY 2017, the hospice wage index will be based on the FY 2016 pre-floor, pre-reclassified hospital wage index. This means that the hospital wage data used for the hospice wage index is not adjusted to take into account any geographic reclassification of hospitals including those in accordance with section 1886(d)(8)(B) or 1886(d)(10) of the Act. The appropriate wage index value is applied to the labor portion of the payment rate based on the geographic area in which the beneficiary resides when receiving RHC or CHC. The appropriate wage index value is applied to the labor portion of the payment rate based on the geographic location of the facility for beneficiaries receiving GIP or Inpatient Respite Care (IRC).

In the FY 2006 Hospice Wage Index final rule (70 FR 45130), we adopted the changes discussed in the OMB Bulletin No. 03-04 (June 6, 2003). This bulletin announced revised definitions for MSAs and the creation of micropolitan statistical areas and combined statistical areas. The bulletin is available online at

http://www.whitehouse.gov/omb/bulletins/b03-04.html.

When adopting OMB's new labor market designations in FY 2006, we identified some geographic areas where there were no hospitals, and thus, no hospital wage index data, on which to base the calculation of the hospice wage index. In the FY 2010 Hospice Wage Index final rule (74 FR 39386), we adopted the policy that for urban labor markets without a hospital from which hospital wage index data could be derived, all of the CBSAs within the state would be used to calculate a statewide urban average pre-floor, pre-reclassified hospital wage index value to use as a reasonable proxy for these areas. In FY 2016, the only CBSA without a hospital from which hospital wage data could be derived is 25980, Hinesville-Fort Stewart, Georgia.

In the FY 2008 Hospice Wage Index final rule (72 FR 50214), we implemented a new methodology to update the hospice wage index for rural areas without a hospital, and thus no hospital wage data. In cases where there was a rural area without rural hospital wage data, we used the average pre-floor, pre-reclassified hospital wage index data from all contiguous CBSAs to represent a reasonable proxy for the rural area. The term “contiguous” means sharing a border (72 FR 50217). Currently, the only rural area without a hospital from which hospital wage data could be derived is Puerto Rico. However, our policy of imputing a rural pre-floor, pre-reclassified hospital wage index value based on the pre-floor, pre-reclassified hospital wage index (or indices) of CBSAs contiguous to a rural area without a hospital from which hospital wage data could be derived does not recognize the unique circumstances of Puerto Rico. In this final rule, for FY 2017, we will continue to use the most recent pre-floor, pre-reclassified hospital wage index value available for Puerto Rico, which is 0.4047.

As described in the August 8, 1997 Hospice Wage Index final rule (62 FR 42860), the pre-floor and pre-reclassified hospital wage index is used as the raw wage index for the hospice benefit. These raw wage index values are then subject to application of the hospice floor to compute the hospice wage index used to determine payments to hospices. Pre-floor, pre-reclassified hospital wage index values below 0.8 are adjusted by a 15 percent increase subject to a maximum wage index value of 0.8. For example, if County A has a pre-floor, pre-reclassified hospital wage index value of 0.3994, we would multiply 0.3994 by 1.15, which equals 0.4593. Since 0.4593 is not greater than 0.8, then County A's hospice wage index would be 0.4593. In another example, if County B has a pre-floor,

pre-reclassified hospital wage index value of 0.7440, we would multiply 0.7440 by 1.15 which equals 0.8556. Because 0.8556 is greater than 0.8, County B's hospice wage index would be 0.8.

b. FY 2016 Implementation of New Labor Market Delineations

OMB has published subsequent bulletins regarding CBSA changes. On February 28, 2013, OMB issued OMB Bulletin No. 13-01, announcing revisions to the delineation of MSAs, Micropolitan Statistical Areas, and Combined Statistical Areas, and guidance on uses of the delineation in these areas. A copy of this bulletin is available online at:

http://www.whitehouse.gov/sites/default/files/omb/bulletins/2013/b-13-01.pdf.

This bulletin states that it “provides the delineations of all Metropolitan Statistical Areas, Metropolitan Divisions, Micropolitan Statistical Areas, Combined Statistical Areas, and New England City and Town Areas in the United States and Puerto Rico based on the standards published on June 28, 2010, in the

Federal Register

(75 FR 37246 through 37252) and Census Bureau data.” In the FY 2016 Hospice Wage Index final rule (80 FR 47178), we adopted the OMB's new area delineations using a 1-year transition. In the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47178), we stated that beginning October 1, 2016, the wage index for all hospice payments would be fully based on the new OMB delineations.

A summary of the comments we received regarding the wage index and our responses to those comments appears below.

Comment:

Several commenters noted their support for the full adoption of the new labor market delineations.

Response:

We appreciate the comments in support of the CBSA delineations finalized in last year's FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47142).

Comment:

One commenter disagreed with fully basing hospice geographic area wage adjustments on the new OMB delineations. The commenter was particularly concerned with the New York City CBSA and the fact that the CBSA contains counties from New Jersey.

Response:

In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47178), we stated that a 1-year transition policy would apply to the FY 2016 payment rates and that, beginning in FY 2017, hospice payments would be fully-based on the new OMB delineations. In addition, we believe that the OMB's CBSA designations reflect the most recent available geographic classifications and are a reasonable and appropriate method of defining geographic areas for the purposes of wage adjusting the hospice payment rates. We do not see any compelling reason to deviate from the OMB designations.

Comment:

A commenter was concerned with the continued use of the pre-floor, pre-reclassified hospital wage index to adjust the hospice payment rates, because this causes continuing volatility of the hospice wage index from one year to the next. The commenter believes that this volatility is often based on inaccurate or incomplete hospital cost report data.

Response:

We believe that annual changes in the wage index reflect real variations in costs of providing care in various geographic locations. The wage index values are based on data submitted on the inpatient hospital cost reports. We utilize efficient means to ensure and review the accuracy of the hospital cost report data and resulting wage index. The hospice wage index is derived from the pre-floor, pre-reclassified wage index, which is calculated based on cost report data from hospitals paid under the Inpatient Prospective Payment System (IPPS). All IPPS hospitals must complete the wage index survey (Worksheet S-3, Parts II and III) as part of their Medicare cost reports. Cost reports will be rejected if Worksheet S-3 is not completed. In addition, our Medicare contractors perform desk reviews on all hospitals' Worksheet S-3 wage data, and we run edits on the wage data to further ensure the accuracy and validity of the wage data. We believe that our review processes result in an accurate reflection of the applicable wages for the areas given.

In addition, we believe that finalizing our proposal to adopt a hospice wage index standardization factor will provide a safeguard to the Medicare program as well as to hospices because it will mitigate fluctuations in the wage index by ensuring that wage index updates and revisions are implemented in a budget neutral manner.

Comment:

A commenter was concerned with the lack of parity between different health care sectors, each of which utilizes some form of a hospital wage index, that experience differing wage index values for specific geographic areas. The commenter also stated that hospital reclassifications create labor market distortions in areas in which hospice costs are not reclassified.

Response:

Several post-acute care payment systems utilize the pre-floor, pre-reclassified hospital wage index as the basis for their wage indexes (for example, the Home Health Prospective Payment System (HH PPS), the Skilled Nursing Facility Prospective Payment System (SNF PPS) and the Inpatient Rehabilitation Facility Prospective Payment System (IRF PPS)). The statutes that govern hospice payment do not provide any discretion to permit a mechanism for allowing hospices to seek geographic reclassification. The reclassification provision is found in section 1886(d)(10) of the Act. Section 1886(d)(10)(C)(i) of the Act states, “The Board shall consider the application of any subsection (d) hospital requesting that the Secretary change the hospital's geographic classification . . .” This provision is only applicable to hospitals, as defined at section 1886(d) of the Act. In addition, we do not believe that using hospital reclassification data would be appropriate as these data are specific to the requesting hospitals and the data may or may not apply to a given hospice in a given instance.

Comment:

One commenter requested that CMS modify the wage index so that the area wage index applicable to any hospice that is located in an urban area of a state may not be less than the area wage index applicable to hospices located in rural areas in that State.

Response:

Section 4410(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33) provides that the area wage index applicable to any hospital that is located in an urban area of a state may not be less than the area wage index applicable to hospitals located in rural areas in that state. This rural floor provision is specific to hospitals. Because the hospital rural floor applies only to hospitals, and not to hospices, we continue to believe the use of the previous year's pre-floor and pre-reclassified hospital wage index results in the most appropriate adjustment to the labor portion of the hospice payment rates. This position is longstanding and consistent with other Medicare payment systems (SNF PPS, IRF PPS, HH PPS, etc.).

Comment:

A commenter requested that CMS explore a wholesale revision and reform of the hospice wage index.

Response:

We are exploring other methodologies for future reform of the Medicare wage index. CMS' “Report to Congress: Plan to Reform the Medicare Wage Index” was submitted by the Secretary on April 11, 2012 and is available on our Wage Index Reform Web page at:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-

Payment/AcuteInpatientPPS/Wage-Index-Reform.html.

Final Action:

After considering the comments received in response to the proposed rule and for the reasons discussed above, we are finalizing our proposal to use the pre-floor, pre-reclassified hospital inpatient wage index as the wage adjustment to the labor portion of the hospice rates. For FY 2017, the updated wage data are for hospital cost reporting periods beginning on or after October 1, 2011 and before October 1, 2012 (FY 2012 cost report data).

The wage index applicable for FY 2017 is available on the CMS Web site at

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/index.html.

As of FY 2012, the wage index values applicable for the upcoming fiscal year and subsequent fiscal years are no longer published in the

Federal Register

(77 FR 44242). The hospice wage index for FY 2017 will be effective October 1, 2016 through September 30, 2017.

2. Hospice Payment Update Percentage

Section 4441(a) of the Balanced Budget Act of 1997 (BBA) amended section 1814(i)(1)(C)(ii)(VI) of the Act to establish updates to hospice rates for FYs 1998 through 2002. Hospice rates were to be updated by a factor equal to the inpatient hospital market basket index set out under section 1886(b)(3)(B)(iii) of the Act, minus 1 percentage point. Payment rates for FYs since 2002 have been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent FYs must be the inpatient market basket percentage for that FY. The Act requires us to use the inpatient hospital market basket to determine the hospice payment rate update. In addition, section 3401(g) of the Affordable Care Act mandates that, starting with FY 2013 (and in subsequent FYs), the hospice payment update percentage will be annually reduced by changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide private nonfarm business multifactor productivity (MFP) (as projected by the Secretary for the 10-year period ending with the applicable FY, year, cost reporting period, or other annual period) (the “MFP adjustment”). A complete description of the MFP projection methodology is available on our Web site at:

http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch.html.

In addition to the MFP adjustment, section 3401(g) of the Affordable Care Act also mandates that in FY 2013 through FY 2019, the hospice payment update percentage will be reduced by an additional 0.3 percentage point (although for FY 2014 to FY 2019, the potential 0.3 percentage point reduction is subject to suspension under conditions specified in section 1814(i)(1)(C)(v) of the Act). The hospice payment update percentage for FY 2017 is based on the estimated inpatient hospital market basket update of 2.7 percent (based on IHS Global Insight, Inc.'s second quarter 2016 forecast with historical data through the first quarter of 2016). Due to the requirements at sections 1886(b)(3)(B)(xi)(II) and 1814(i)(1)(C)(v) of the Act, the estimated inpatient hospital market basket update for FY 2017 of 2.7 percent must be reduced by a MFP adjustment as mandated by Affordable Care Act (currently estimated to be 0.3 percentage point for FY 2017). The estimated inpatient hospital market basket update for FY 2017 is reduced further by 0.3 percentage point, as mandated by the Affordable Care Act. In effect, the hospice payment update percentage for FY 2017 is 2.1 percent.

Currently, the labor portion of the hospice payment rates is as follows: For RHC, 68.71 percent; for CHC, 68.71 percent; for General Inpatient Care, 64.01 percent; and for Respite Care, 54.13 percent. The non-labor portion is equal to 100 percent minus the labor portion for each level of care. Therefore, the non-labor portion of the payment rates is as follows: For RHC, 31.29 percent; for CHC, 31.29 percent; for General Inpatient Care, 35.99 percent; and for Respite Care, 45.87 percent.

A summary of the comments we received regarding the payment rates and our responses to those comments appear below.

Comment:

Several commenters noted their support of the hospice payment update percentage.

Response:

We appreciate the comments in support of the hospice payment update percentage.

Comment:

One commenter suggested the CMS eliminate the hospice payment update percentage to hospice payments for FY 2017, as the commenter maintains that payment adequacy for hospice providers is generally positive. Other commenters noted that the proposed hospice payment update percentage is not sufficient to keep pace with rising costs of providing hospice care and suggested that CMS revisit the proposed hospice payment update percentage for potential increase.

Response:

The payment update percentage to the hospice rates is required by statute, as previously described in detail in this section, and we do not have regulatory authority to alter the payment update.

Final Action:

We are implementing the hospice payment update percentage as discussed in the proposed rule. Based on IHS Global Insight, Inc.'s updated forecast, the hospice payment update percentage for FY 2017 will be 2.1 percent for hospices that submit the required quality data and 0.1 percent for hospices that do not submit the required quality data.

3. FY 2017 Hospice Payment Rates

There are four payment categories that are distinguished by the location and intensity of the services provided. The base payments are adjusted for geographic differences in wages by multiplying the labor share, which varies by category, of each base rate by the applicable hospice wage index. A hospice is paid the RHC rate for each day the beneficiary is enrolled in hospice, unless the hospice provides continuous home care, IRC, or general inpatient care. CHC is provided during a period of patient crisis to maintain the person at home; IRC is short-term care to allow the usual caregiver to rest and be relieved from caregiving; and General Inpatient Care (GIP) is to treat symptoms that cannot be managed in another setting.

As discussed in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47172), we implemented two different RHC payment rates, one RHC rate for the first 60 days and a second RHC rate for days 61 and beyond. In addition, in the final rule, we adopted a Service Intensity Add-on (SIA) payment, when direct patient care is provided by a RN or social worker during the last 7 days of the beneficiary's life. The SIA payment is equal to the CHC hourly rate multiplied by the hours of nursing or social work provided (up to 4 hours total) that occurred on the day of service. In order to maintain budget neutrality, as required under section 1814(i)(6)(D)(ii) of the Act, the new RHC rates were adjusted by a SIA budget neutrality factor.

As discussed in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47177), we will continue to make the SIA payments budget neutral through an annual determination of the SIA budget neutrality factor (SBNF), which will then be applied to the RHC payment

rates. The SBNF will be calculated for each FY using the most current and complete FY utilization data available at the time of rulemaking. For FY 2017, the budget neutrality adjustment that applies to days 1 through 60 is calculated to be 1.0000. The budget neutrality adjustment that applies to days 61 and beyond is calculated to be 0.9999.

For FY 2017, we are applying a wage index standardization factor to the FY 2017 hospice payment rates in order to ensure overall budget neutrality when updating the hospice wage index with more recent hospital wage data. Wage index standardization factors are applied in other payment settings such as under home health Prospective Payment System (PPS), IRF PPS, and SNF PPS. Applying a wage index standardization factor to hospice payments will eliminate the aggregate effect of annual variations in hospital wage data. We believe that adopting a hospice wage index standardization factor will provide a safeguard to the Medicare program as well as to hospices because it will mitigate fluctuations in the wage index by ensuring that wage index updates and revisions are implemented in a budget neutral manner. To calculate the wage index standardization factor, we simulated total payments using the FY 2017 hospice wage index and compared it to our simulation of total payments using the FY 2016 hospice wage index. By dividing payments for each level of care using the FY 2017 wage index by payments for each level of care using the FY 2016 wage index, we obtain a wage index standardization factor for each level of care (RHC days 1-60, RHC days 61+, CHC, IRC, and GIP).

Lastly, the hospice payment rates for hospices that submit the required quality data will be increased by the full FY 2017 hospice payment update percentage of 2.1 percent as discussed in section III.C.3 of this final rule. The FY 2017 RHC rates are shown in Table 11. The FY 2017 payment rates for CHC, IRC, and GIP are shown in Table 12.

Table 11—FY 2017 Hospice RHC Payment Rates

Code

Description

FY 2016

payment rates

SBNF

Wage index

standardization

factor

FY 2017

hospice

payment

update

percentage

FY 2017

payment rates

651

Routine Home Care (days 1-60)

$186.84

× 1.0000

× 0.9989

× 1.021

$190.55

651

Routine Home Care (days 61+)

146.83

× 0.9999

× 0.9995

× 1.021

149.82

Table 12—FY 2017 Hospice CHC, IRC, and GIP Payment Rates

Code

Description

FY 2016

payment rates

Wage index

standardization

factor

FY 2017

hospice

payment

update

percentage

FY 2017

payment rates

652

Continuous Home Care

Full Rate = 24 hours of care.

$40.19 = FY 2017 hourly rate.

$944.79

× 1.0000

× 1.021

$964.63

655

Inpatient Respite Care

167.45

× 1.0000

× 1.021

170.97

656

General Inpatient Care

720.11

× 0.9996

× 1.021

734.94

Sections 1814(i)(5)(A) through (C) of the Act require that hospices begin submitting quality data, based on measures to be specified by the Secretary. In the FY 2012 Hospice Wage Index final rule (76 FR 47320 through 47324), we implemented a Hospice Quality Reporting Program (HQRP), as required by section 3004 of the Affordable Care Act. Hospices were required to begin collecting quality data in October 2012, and submit that quality data in 2013. Section 1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014 and for each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements with respect to that FY. The FY 2017 rates for hospices that do not submit the required quality data will be updated by the FY 2017 hospice payment update percentage of 2.1 percent minus 2 percentage points. These rates are shown in Tables 13 and 14.

Table 13—FY 2017 Hospice RHC Payment Rates for Hospices That

DO NOT

Submit the Required Quality Data

Code

Description

FY 2016

payment rates

SBNF

Wage index

standardization

factor

FY 2017

hospice

payment

update of 2.1% minus 2

percentage points = 0.1%

FY 2017

payment rates

651

Routine Home Care (days 1-60)

$186.84

× 1.0000

× 0.9989

× 1.001

$186.82

651

Routine Home Care (days 61+)

146.83

× 0.9999

× 0.9995

× 1.001

146.89

Table 14—FY 2017 Hospice CHC, IRC, and GIP Payment Rates for Hospices That

DO NOT

Submit the Required Quality Data

Code

Description

FY 2016

payment rates

Wage index

standardization

factor

FY 2017

hospice

payment

update of 2.1% minus 2

percentage points = 0.1%

FY 2017

payment rates

652

Continuous Home Care

Full Rate = 24 hours of care.

$39.41 = FY 2017 hourly rate.

$944.79

× 1.0000

× 1.001

$945.73

655

Inpatient Respite Care

167.45

× 1.0000

× 1.001

167.62

656

General Inpatient Care

720.11

× 0.9996

× 1.001

720.54

A summary of the comments we received regarding the payment rates and our responses to those comments appear below.

Comment:

A commenter asked if the application of the standardization factor is premature or is it part of the continued progression of hospice reimbursement from hybrid fee-for-service/health maintenance organization to a full case-mix or value-based purchasing (VBP) system.

Response:

We believe that applying a wage index standardization factor to the hospice rates is appropriate. The application of the standardization factor will mitigate any potential effects due to the annual variations in hospital wage data. Moreover, this approach creates a level of protection for the Medicare program as well as to hospices, as it minimizes the impacts of any fluctuations in the wage index.

Comment:

Several commenters requested that the SIA Payment eligibility requirements be modified to include additional hospice services, including visits from licensed practical nurses (LPNs), music therapists, and other professionals providing care during the last 7 days of life. In addition, several commenters requested that data be collected in order to determine if the SIA Payment increased the number of visits during beneficiaries' most intensive time of need for skilled care (specifically, the last 7 days of life).

Response:

CMS finalized the SIA payment policy in the FY 2016 Hospice Wage Index and Payment Update final rule (80 FR 47141) and we did not solicit comments on a proposal to modify these policy parameters in the FY 2017 Hospice Wage Index and Payment Rate update proposed rule (81 FR 25498). However, we will continue to consider and monitor for potential refinements to this policy, including current monitoring efforts that were described in the FY 2017 Hospice Wage Index and Payment Rate Update proposed rule (81 FR 25498) in response to these policy changes, and we will take these comments into account as we continue to do so.

Comment:

One commenter noted that there have been issues with the technical implementation of the SIA payment such that payment adjustments are not occurring as originally intended.

Response:

While the technical implementations issues with regards to SIA payments have been minimal, we appreciate this comment and are working diligently with appropriate stakeholders to expedite the appropriate system remediation to ensure accurate payment to providers.

Comment:

One commenter expressed concern that the RHC rate payment amount for Days 61 and beyond may lead to payment inadequacy for patients with long lengths of stay. One commenter noted that the episode gap required by the two RHC rates policy implemented for FY 2016 could have a negative impact on those hospices that accept patients via transfers. Moreover, the commenter noted that CMS should consider payment adjustments if a patient is transferred from one hospice to another, particularly at or near day 61 of a hospice episode.

Response:

We appreciate the comments and the concern for appropriate payment for long stay beneficiaries as well as transfer patients. The creation of the two RHC rates (one for days 1-60 and a another for days 61 and beyond) was finalized in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47141), and we did not propose any changes for FY 2017 nor did we solicit comments on any future changes. In response to public comments, we stated in the FY 2016 Hospice Wage Index and Payment Rate Update final rule that allowing for a higher payment for a new hospice election (or in transfer situations) without a gap in hospice care of greater than 60 days goes against our intent to mitigate the incentive to discharge and readmit patients (or transfer patients) at or around day 60 for the purposes of obtaining a higher payment (80 FR 47168). With regards to the commenter's concern regarding reimbursement for long lengths of stay, we refer the commenter to the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47142), where we discuss the rationale for the creation of a higher RHC rate for days 1-60 and a lower rate for days 61 and beyond. In that final rule, we noted that hospice stays manifest in a `U-Shaped' pattern (that is, the intensity of services provided is higher both at admission and near death and, conversely, is relatively lower during the middle period of the hospice episode). Since hospice care is most profitable during the long, low-cost middle portions of an episode, longer episodes have very profitable, long middle segments (80 FR 47161). Therefore, in order to better align hospice payments with service intensity during a hospice episode of care, we implemented a higher RHC rate for days 1-60 and a lower rate for days 61 and beyond, effective January 1, 2016. We also implemented a service intensity add-on (SIA) payment policy that reimburses hospices for visits performed during the last 7 days of a beneficiary's life (in addition to RHC per diem payments), also effective January 1, 2016. We will continue to monitor for and consider potential refinements to these policies as appropriate.

Comment:

A commenter noted that Medicaid agencies have encountered challenges in the implementation of the payment changes due to hospice reform.

Response:

We appreciate this comment and are working diligently with appropriate stakeholders and State Agencies to facilitate effective implementation of hospice payment reform.

Final Action:

We are implementing the updates to hospice payment rates as discussed in the proposed rule.

4. Hospice Cap Amount for FY 2017

As discussed in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47183), we implemented changes mandated by the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act). Specifically, for accounting years that end after September 30, 2016 and before October 1, 2025, the hospice cap is updated by the hospice payment update percentage rather than using the consumer price index for urban consumers (CPI-U). As required by section 1814(i)(2)(B)(ii) of the Act, the hospice cap amount for the 2016 cap year, starting on November 1, 2015 and ending on October 31, 2016, is equal to the 2015 cap amount ($27,382.63) updated by the FY 2016 hospice payment update percentage of 1.6 percent. As such, the 2016 cap amount is $27,820.75.

In the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47142), we finalized aligning the cap accounting year with the federal FY beginning in 2017. Therefore, the 2017 cap year will start on October 1, 2016 and end on September 30, 2017. Table 26 in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47185) outlines the timeframes for counting beneficiaries and payments during the 2017 transition year. The hospice cap amount for the 2017 cap year will be $28,404.99, which is equal to the 2016 cap amount ($27,820.75) updated by the FY 2017 hospice payment update percentage of 2.1 percent.

A summary of public comments and our responses to comments on the hospice cap are summarized below:

Comment:

One commenter expressed concerns that the methodology used to calculate the hospice cap creates an incentive for rural hospices to inflate their utilization of the GIP level of care, as some rural hospices may do this to gain higher reimbursement by placing patients at the GIP level of care that may not qualify for that level of care.

Response:

The hospice aggregate cap is calculated based on total reimbursement across all levels of care. In addition, the hospice inpatient cap limits total payments to the hospice for inpatient care (general or respite). Total payments are subject to a limitation that total inpatient care days for Medicare patients does not exceed 20 percent of the total days for which patients had elected hospice care. We urge providers to adhere to appropriate guidelines with respect to the hospice levels of care. We note that in a March 2016 Office of Inspector General (OIG) report, OIG found that hospices billed one-third of GIP stays inappropriately, costing Medicare $268 million in 2012. According to the report, “hospices commonly billed for GIP when the beneficiary did not have uncontrolled pain or unmanaged symptoms.” (

http://oig.hhs.gov/oei/reports/oei-02-10-00491.asp

) As such, we will continue to monitor the use of the various levels of care in order to identify any aberrant or problematic behavior.

Final Action:

We are implementing the changes to the hospice cap amount as discussed in the proposed rule.

C. Proposed Updates to the Hospice Quality Reporting Program (HQRP)

1. Background and Statutory Authority

Section 3004(c) of the Affordable Care Act amended section 1814(i)(5) of the Act to authorize a quality reporting program for hospices. Section 1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014 and each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements for that FY. Depending on the amount of the annual update for a particular year, a reduction of 2 percentage points could result in the annual market basket update being less than 0 percent for a FY and may result in payment rates that are less than payment rates for the preceding FY. Any reduction based on failure to comply with the reporting requirements, as required by section 1814(i)(5)(B) of the Act, would apply only for the particular FY involved. Any such reduction would not be cumulative or be taken into account in computing the payment amount for subsequent FYs. Section 1814(i)(5)(C) of the Act requires that each hospice submit data to the Secretary on quality measures specified by the Secretary. The data must be submitted in a form, manner, and at a time specified by the Secretary.

2. General Considerations Used for Selection of Quality Measures for the HQRP

Any measures selected by the Secretary must be endorsed by the consensus-based entity, which holds a contract regarding performance measurement, including the endorsement of quality measures, with the Secretary under section 1890(a) of the Act. This contract is currently held by the National Quality Forum (NQF). However, section 1814(i)(5)(D)(ii) of the Act provides that in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the consensus-based entity, the Secretary may specify measures that are not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus-based organization identified by the Secretary. Our paramount concern is the successful development of an HQRP that promotes the delivery of high quality healthcare services. We seek to adopt measures for the HQRP that promote person-centered, high quality, and safe care. Our measure selection activities for the HQRP take into consideration input from the Measure Applications Partnership (MAP), convened by the NQF, as part of the established CMS pre-rulemaking process required under section 1890A of the Act. The MAP is a public-private partnership comprised of multi-stakeholder groups convened by the NQF for the primary purpose of providing input to CMS on the selection of certain categories of quality and efficiency measures, as required by section 1890A(a)(3) of the Act. By February 1st of each year, the NQF must provide that input to CMS. Input from the MAP is located at

http://www.qualityforum.org/Setting_Priorities/Partnership/Measure_Applications_Partnership.aspx.

We also take into account national priorities, such as those established by the National Priorities Partnership at (

http://www.qualityforum.org/npp/

), the HHS Strategic Plan (

http://www.hhs.gov/secretary/about/priorities/priorities.html

), the National Strategy for Quality Improvement in Healthcare, (

http://www.ahrq.gov/workingforquality/nqs/nqs2013annlrpt.htm

) and the CMS Quality Strategy (

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.html

). To the extent practicable, we have sought to adopt measures endorsed by member organizations of the National Consensus Project (NCP), recommended by multi-stakeholder organizations, and developed with the input of providers, purchasers and/or payers, and other stakeholders.

3. Policy for Retention of HQRP Measures Adopted for Previous Payment Determinations

For the purpose of streamlining the rulemaking process, we finalized our policy in the FY 2016 Hospice Wage Index final rule (80 FR 47187) that when we adopt measures for the HQRP beginning with a payment

determination year, these measures would automatically be adopted for all subsequent years' payment determinations, unless we proposed to remove, suspend, or replace the measures. Quality measures would be considered for removal by CMS for reasons including, but not limited to:

• Measure performance among hospices was so high and unvarying that meaningful distinction in improvements in performance could no longer be made;

• Performance or improvement on a measure did not result in better patient outcomes;

• A measure did not align with current clinical guidelines or practice;

• A more broadly applicable measure (across settings, populations, or conditions) for the particular topic was available;

• A measure that was more proximal in time to desired patient outcomes for the particular topic was available;

• A measure that was more strongly associated with desired patient outcomes for the particular topic was available; or

• Collection or public reporting of a measure led to negative unintended consequences.

For any such removal, the public would be given an opportunity to comment through the annual rulemaking process. However, if there were reason to believe continued collection of a measure raised potential safety concerns, we would take immediate action to remove the measure from the HQRP and not wait for the annual rulemaking cycle. The measures would be promptly removed, and we would immediately notify hospices and the public of such a decision through the usual CMS HQRP communication channels, including postings and announcements on the CMS HQRP Web site, Medicare Learning Network (MLN) eNews communications, national provider association calls, and announcements on Open Door Forums and Special Open Door Forums. In such instances, the removal of a measure would be formally announced in the next annual rulemaking cycle.

To further streamline the rulemaking process, we proposed to codify that if measures we are using in the HQRP have non-substantive changes in their specifications change as part of their NQF endorsement process, we would continue to utilize the measure with their new endorsed status in the HQRP. As mentioned previously, quality measures selected for the HQRP must be endorsed by the NQF unless they meet the statutory criteria for exception under section 1814(i)(5)(D)(ii) of the Act. The NQF is a voluntary consensus standard-setting organization with a diverse representation of consumer, purchaser, provider, academic, clinical, and other healthcare stakeholder organizations. The NQF was established to standardize healthcare quality measurement and reporting through its consensus measure development process (

http://www.qualityforum.org/About_NQF/Mission_and_Vision.aspx

). The NQF undertakes review of: (a) New quality measures and national consensus standards for measuring and publicly reporting on performance, (b) regular maintenance processes for endorsed quality measures, (c) measures with time-limited endorsement for consideration of full endorsement, and (d) ad hoc review of endorsed quality measures, practices, consensus standards, or events with adequate justification to substantiate the review. Through NQF's measure maintenance process, NQF-endorsed measures are sometimes updated to incorporate changes that we believe do not substantially change the nature of the measure. Examples of such changes could be updated diagnosis or procedure codes, changes to exclusions to a particular patient/consumer population, or definitions. We believe these types of maintenance changes are distinct from more substantive changes to measures. Additionally, since the NQF endorsement and measure maintenance process is one that ensures transparency, public input, and discussion among representatives across the healthcare enterprise,

5

we believe that the NQF measure endorsement and maintenance process itself is transparent, scientifically rigorous, and provides opportunity for public input. Thus, we proposed to codify at § 418.312 that if the NQF makes only non-substantive changes to specifications for HQRP measures in the NQF's re-endorsement process, we would continue to utilize the measure in its new endorsed status. If NQF-endorsed specifications change and we do not adopt those changes, then we would propose the measure as an application. An application of a NQF-endorsed quality measure is utilized in instances when CMS has identified a need to use a NQF-endorsed measure in a QRP but need to use it with one or more modifications to the quality measure's specifications. These modifications pertain to, but are not limited to, one or more of the following aspects of a NQF-endorsed quality measure: (a) Numerator, (b) denominator, (c) setting, (d) look-back period, (e) calculation period, (f) risk adjustment, and (g) revisions to data elements used to collect the data required for the measure, etc. CMS may adopt a quality measure for the HQRP under section 1814(i)(5)(D)(ii) of the Act, which states, “In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by [the NQF], the Secretary may specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary.” Reasons for not adopting changes in measure specifications to a measure may include any of the aforementioned criteria in this section, including that the new specification does not align with clinical guidelines or practice or that the new specification leads to negative unintended consequences. Finally, we will continue to use rulemaking to adopt substantive updates made by the NQF to the endorsed measures we have adopted for the HQRP. We continue to make these determinations about what constitutes a substantive versus non-substantive change on a measure-by-measure basis. A change would be deemed substantive if the intent of the measure changes, the facility/setting changes, the data sources changes, the level of analysis changes, and/or the measure is removed. We will continue to provide updates about changes to measure specifications as a result of NQF endorsement or maintenance processes through the normal CMS HQRP communication channels, including postings and announcements on the CMS HQRP Web site, MLN eNews communications, national provider association calls, and announcements on Open Door Forums and Special Open Door Forums.

5

“NQF: How Endorsement Happens—National Quality Forum.” 2010. 26 Jan. 2016

http://www.qualityforum.org/Measuring_Performance/ABCs/How_Endorsement_Happens.aspx

.

Comment:

CMS received two comments on our proposal to codify that if measures used in the HQRP undergo non-substantive changes as part of their NQF re-endorsement process, we would utilize the measure with their new endorsed status without going through a new notice-and-comment rulemaking process. One commenter supported the proposal to codify this policy. Another commenter was concerned that CMS's plan to adopt non-substantive change(s) approved through the NQF re-endorsement process without a notice-and-comment rulemaking process does not allow providers and vendors the

opportunity to provide input on changes to measure specifications. Additionally, the commenter also had concerns that adopting non-substantive changes to measures outside of the rulemaking process would limit the ability for hospices and vendors to make necessary changes to data collection systems to implement non-substantive updates to measures.

Response:

We thank commenters for their support of this proposal, and for their concerns raised. We agree that the opportunity for the public to provide input on all changes to measure specifications (both substantive and non-substantive) is vital to the measure development, endorsement, and maintenance process. We also agree with the commenter that vendors and the hospice community need ample time to implement changes to measure specifications, especially those that would warrant updates to Hospice Item Set (HIS) items or technical specifications. We would like to reassure commenters that, as stated in this rule, we will still propose substantive changes to measure through rulemaking. With regard to non-substantive measure changes that could occur as a result of the measure maintenance and re-endorsement process, we would like to clarify that the NQF processes for endorsement and maintenance of measures includes review by an expert Standing Committee, public and Member comment periods, Member voting, consideration by the Consensus Standards Approval Committee (CSAC), endorsement by the Board of Directors, and a 30-day appeals period. The NQF endorsement and maintenance (re-endorsement) process allows ample opportunity for NQF member and public input, during the measure development, endorsement and maintenance phases. We encourage hospices to participate in these NQF comment periods to offer their insights about potential impacts of changes to measures and measure specifications. We believe that in instances of non-substantive changes to measure specifications, maximizing the use of NQF opportunities for public input allows us to efficiently and expediently adopt non-substantive, but important changes to measures. Regarding the commenter's concern about whether this policy will allow providers ample time to implement and adopt non-substantive changes, we would like to point out that when non-substantive changes put forth by the NQF are adopted, we are not required to immediately implement those changes on the date of re-endorsement by NQF. Once a non-substantive change is endorsed by NQF, we will consider the time necessary for providers and vendors to implement the change. If newly endorsed non-substantive changes require updates to data collection mechanisms (for example, updates to HIS specifications) or associated training materials, we will allow ample time for providers and vendors to prepare and implement such changes. As noted in the rule, we will communicate the endorsement of non-substantive changes, decisions about whether to adopt non-substantive changes, and timeline for implementation of non-substantive changes through regular HQRP communication channels. Additionally, CMS welcomes comment on any non-substantive changes adopted under this mechanism through the appropriate sub-regulatory communication channels, including but not limited to: NQF public comment periods held as part of endorsement processes, feedback from providers on the Hospice Quality HelpDesk, and feedback from the provider community on ODFs and SODFs. CMS will make such comments and their responses available to the public under the appropriate sub-regulatory communication channels. Finally, we would like to note that this policy is consistent with similar policies in other QRPs.

Comment:

We received a few comments on our previously finalized policy for measure retention. These commenters encouraged CMS's continued consideration of whether previously adopted quality measures are appropriate for retention in the HQRP. Commenters encouraged CMS to eliminate measures that are no longer considered to effectively measure quality.

Response:

We thank commenters for their suggestions surrounding measure retention and removal. We agree that any quality measures proposed and retained in the HQRP should continue to provide meaningful data to providers and consumers on quality of care. We regularly conduct measure testing activities according to NQF guidelines and the Blueprint for the CMS Measures Management System Version 12.0 (

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint-120.pdf

) to ensure that measures continue to demonstrate scientific acceptability (including reliability and validity) and meet the goals of the HQRP, which include distinguishing performance among hospices and contributing to better patient outcomes. As outlined in this section of the rule, we will propose a measure for removal if meaningful distinctions in quality of care can no longer be made from the measure due to high and unvarying performance.

Final Action:

After consideration of the comments, we are codifying our policy that once a quality measure is adopted, it be retained for use in the subsequent fiscal year payment determinations until otherwise stated, as proposed.

4. Previously Adopted Quality Measures for FY 2017 and FY 2018 Payment Determination

As stated in the CY 2013 HH PPS final rule (77 FR 67068 through 67133), CMS expanded the set of required measures to include additional measures endorsed by NQF. We also stated that to support the standardized collection and calculation of quality measures by CMS, collection of the needed data elements would require a standardized data collection instrument. In response, CMS developed, tested, and implemented a hospice patient-level item set, the HIS. Hospices are required to submit a HIS-Admission record and a HIS-Discharge record for each patient admission to hospice since July 1, 2014. In developing the standardized HIS, we considered comments offered in response to the CY 2013 HH PPS proposed rule (77 FR 41548 through 41573). In the FY 2014 Hospice Wage Index final rule (78 FR 48257), and in compliance with section 1814(i)(5)(C) of the Act, we finalized the specific collection of data items that support the following 6 NQF-endorsed measures and 1 modified measure for hospice:

• NQF #1617 Patients Treated with an Opioid who are Given a Bowel Regimen,

• NQF #1634 Pain Screening,

• NQF #1637 Pain Assessment,

• NQF #1638 Dyspnea Treatment,

• NQF #1639 Dyspnea Screening,

• NQF #1641 Treatment Preferences,

• NQF #1647 Beliefs/Values Addressed (if desired by the patient) (modified).

To achieve a comprehensive set of hospice quality measures available for widespread use for quality improvement and informed decision making, and to carry out our commitment to develop a quality reporting program for hospices that uses standardized methods to collect data needed to calculate quality measures, we finalized the HIS effective July 1, 2014 (78 FR 48258). To meet the quality reporting requirements for hospices for the FY 2016 payment determination and each subsequent year, we require regular and ongoing

electronic submission of the HIS data for each patient admission to hospice after July 1, 2014, regardless of payer or patient age (78 FR 48234 through 48258). We finalized a requirement in the FY 2014 Hospice Wage Index final rule (78 FR 48258) that hospice providers collect data on all patients to ensure that all patients regardless of payer or patient age are receiving the same care and that provider metrics measure performance across the spectrum of patients.

Hospices are required to complete and submit a HIS-Admission and a HIS-Discharge record for each patient admission. Hospices failing to report quality data via the HIS for patient admissions occurring in 2016 will have their market basket update reduced by 2 percentage points in FY 2018 (beginning in October 1, 2017). In the FY 2015 Hospice Wage Index final rule (79 FR 50485 through 50487), we finalized the proposal to codify the HIS submission requirement at § 418.312. The System of Record (SOR) Notice titled “Hospice Item Set (HIS) System,” SOR number 09-70-0548, was published in the

Federal Register

on April 8, 2014 (79 FR 19341).

Table 15—Previously Finalized Quality Measures Affecting the FY 2017 Payment Determination and Subsequent Year

Quality measure

NQF ID#

Type

Submission method

Data submission deadlines

Treatment Preferences

Beliefs/Values Addressed

1641

1647

Process Measure

Hospice Item Set

Within 30 days of patient admission or discharge (Event Date).

Pain Screening

1634

Pain Assessment

1637

Dyspnea Screening

1639

Dyspnea Treatment

1638

Patients Treated with an Opioid who are Given a Bowel Regimen

1617

Comment:

CMS received a comment regarding the retirement of the seven day length of stay (LOS) exclusion for six of the care process measures currently implemented in the HQRP. This commenter expressed concern that in eliminating the LOS exclusion, provider behavior may shift towards focusing on completing the HIS requirements and compliance at the expense of addressing the needs and preferences of imminently dying patients. Additionally, this commenter recommended that CMS reconsider eliminating the LOS exclusion or risk adjust for hospices with an excessive number of short-stay patients for patients.

Response:

We appreciate the commenters' input on the retirement of the LOS exclusion specification for six of the quality measures currently implemented in the HQRP. Developing and adopting measures that are meaningful and do not lead to negative unintended consequences for patients or providers is important to us. At the time the measures were developed, technical experts recommended that short patient stays be excluded from those measures' denominators for assessing quality of care in hospices. However, no national data regarding the implications of the LOS exclusion was available to the Technical Expert Panel (TEP) at that time. CMS's contractor analyzed data from the HIS to examine the implications of the LOS exclusion on hospices' denominator size and quality measure (QM) scores. Additionally, this analysis examined the timing of when hospices perform the care processes assessed in the quality measures. These analyses were conducted using HIS-Admission and HIS-Discharge records for stays in July 1, 2014 through March 31, 2015. The results of these analyses demonstrated that the denominator sizes for the HQRP QMs are largely impacted by the current 7-day LOS exclusion used to calculate the QMs. Excluding stays with LOS less than 7 days prevents some hospices from being included in QM score calculations because they do not have any qualifying patient stays. Therefore, removing the LOS exclusion criteria will increase the number of patients included in the measures, and thus the number of hospices that are included in the QM calculation. The impact of the LOS exclusions on the distribution of hospices' scores is generally small for all of the QMs. In addition, these analyses revealed that the care processes targeted by the QMs are performed on the day of, or within one day of, admission for the vast majority of patient stays. For example, among patient admissions for which a pain screening was administered, approximately 92 percent of screenings occurred on the day of admission and close to 99 percent occurred within 1 day of admission. This suggested that including stays of less than 7 days in QM calculations (that is, removing the QM LOS exclusion) could be appropriate and would not create a burden on hospices. In response to these results, the individual QMs were submitted by the measures' stewards to the NQF Palliative Care and End of Life Project for re-endorsement in February 2016 and received preliminary approval. In sum, 6 of the 7 current HIS measures that were adopted in the FY 2014 Hospice Wage Index final rule excluded beneficiaries with a LOS of <7 days from the denominator. However, since these measures were adopted in the HQRP, they have undergone their endorsement maintenance with the NQF. As part of the maintenance endorsement, the LOS exclusion for the 6 HIS measures was proposed for removal. NQF has indicated initial support for the removal of the LOS exclusion, and pending NQF maintenance endorsement of the previously adopted measures, we anticipate that the entire set of the 7 HIS measures will no longer exclude any patients with LOS <7 days in future public reporting and use in the HQRP. We appreciate the commenters' recommendation to risk adjust these measures and will consider this recommendation for future measure development efforts.

Comment:

CMS received one comment requesting additional items or response options on the HIS V1.00.0 to capture instances where data regarding preferences or other care processes captured on the HIS are not available for non-verbal patients admitted to hospice who do not have a formal caregiver or responsible party available.

Response:

We thank the commenter for their comment. For additional information on how to respond to current HIS items when the patient is nonverbal and/or a caregiver is unavailable, we refer readers to the HIS Manual V1.02 available on the Hospice

Item Set portion of the CMS HQRP Web site:

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html.

Specifically, we refer readers to the HIS Manual Section F Item-Specific Tips, which specifies roles of responsible parties for patients unable to self-report. The HIS Manual states that the “Responsible party” refers to the legally responsible or authorized individual, such as the Health Care Power of Attorney or legal guardian. In the rare cases where there is no legal guardian or power of attorney identified, the hospice should use state law guidance to identify the appropriate surrogate decision-maker. Other items that require patient or caregiver input, such as the pain assessment items, can be completed for nonverbal patients using the nonverbal assessment processes described in the HIS Manual.

5. Proposed Removal of Previously Adopted Measures

As mentioned in section III.C.3, a measure that is adopted and implemented in the HQRP will be adopted for all subsequent years, unless the measure is proposed for removal, suspension, or replacement by CMS. Policies and criteria for removing a measure include those mentioned in section III.C.3 of this proposed rule. CMS is not proposing to remove any of the current HQRP measures at this time. Any future proposals regarding removal, suspension, or replacement of measures will be proposed in this section of future rules.

6. Proposed New Quality Measures for FY 2019 Payment Determinations and Subsequent Years and Concepts Under Consideration for Future Years

a. Background and Considerations in Developing New Quality Measures for the HQRP

As noted in section III.C.2 of this proposed rule, CMS's paramount concern is to develop quality measures that promote care that is person-centered, high quality, and safe. In identifying priority areas for future measure enhancement and development, CMS takes into consideration input from numerous stakeholders, including the MAP, the MedPAC, Technical Expert Panels (TEP), and national priorities, such as those established by the National Priorities Partnership, the HHS Strategic Plan, the National Strategy for Quality Improvement in Healthcare, and the CMS Quality Strategy. In addition, CMS takes into consideration vital feedback and input from research published by our payment reform contractor, as well as important observations and recommendations contained in the Institute of Medicine (IOM) report, titled “Dying in America,” released in September 2014.

6

Finally, the current HQRP measure set is also an important consideration for future measure development areas; future measure development areas should complement the current HQRP measure set, which includes HIS measures and Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Hospice Survey measures.

6

IOM (Institute of Medicine). 2014. Dying in America: Improving quality and honoring individual preferences near the end of life. Washington, DC: The National Academies Press.

As stated in the FY 2016 Hospice Wage Index final rule (80 FR 47188), based on input from stakeholders, CMS identified several high priority areas for future measure development, including: A patient reported pain outcome measure; claims-based measures focused on care practices patterns, including skilled visits in the last days of life; responsiveness of the hospice to patient and family care needs; and hospice team communication and care coordination. Of the aforementioned measure areas, CMS has pursued measure development for two quality measures: Hospice Visits when Death is Imminent Measure Pair, and Hospice and Palliative Care Composite Process Measure-Comprehensive Assessment at Admission. These measures were included in CMS' List of Measures under Consideration (MUC) list for 2015 and discussed at the MAP meeting on December 14 and 15, 2015. All materials related to the MUC list and the MAP's recommendations for each measure can be found on the National Quality Forum Web site, MAP Post-Acute Care/Long-Term Care Workgroup Web page at:

http://www.qualityforum.org/ProjectMaterials.aspx?projectID=75370.

The MAP supported the direction of each proposed measure.

Comment:

Many comments were received about the HQRP quality measures and concepts under consideration for future years. Overall, commenters were supportive of CMS's efforts to develop a more robust quality reporting program that includes development of two new quality measures, the Hospice Visits when Death is Imminent Measure Pair, and Hospice and Palliative Care Composite Process Measure-Comprehensive Assessment at Admission. In addition to the two measures we proposed, regarding measure development in future years, commenters urged CMS to focus on meaningful quality measures and encouraged CMS to move towards the development of outcome measures. Several commenters noted the complexities associated with developing outcomes measures. These commenters also recommended that CMS conduct regular measure testing activities to ensure that all measures currently implemented in the HQRP are relevant and meaningful to providers and consumers. Finally, some commenters recommended the development of future measures of hospice live discharge rates. Commenters believe that such measures could contribute to quality information and hospice performance.

Response:

We appreciate the commenters' input and recommendations for future measure development areas for the HQRP. We plan to continue developing the HQRP to respond to the measure gaps identified by the MAP and others, and align measure development with the National Quality Strategy and the CMS Quality Strategy. We will take these comments into consideration in developing and implementing measures for future inclusion in the HQRP. We would like to assure commenters that we are pursuing opportunities related to the development of live-discharge measures through environmental scans, public engagement, and participation in special topic panels. We would also like to assure commenters that for all measures implemented in the HQRP, we regularly conduct measure testing activities according to the Blueprint for the CMS Measures Management System Version 12.0 (

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint-120.pdf

). This ensures that measures continue to demonstrate scientific acceptability (including reliability and validity) and meet the goals of the HQRP, which include distinguishing performance among hospices and contributing to better patient outcomes. If measure testing activities reveal that a measure meets one of the conditions for removal that is listed in the proposed rule (measure performance among hospices high and unvarying, performance or improvement in a measure does not result in better patient outcomes, etc.), the measure will be considered for removal from the HQRP to avoid unintended consequences and to ensure that providers' data collection efforts are meaningful and are contributing to quality of care. Finally, we would like to assure commenters that we continue to explore opportunities to pursue

hospice outcome measures, and we appreciate the commenters' support for such development efforts.

b. New Quality Measures for the FY 2019 Payment Determination and Subsequent Years

We proposed two new quality measures for the HRQP for the FY 2019 payment determination and subsequent years: Hospice Visits when Death is Imminent Measure Pair, and Hospice and Palliative Care Composite Process Measure-Comprehensive Assessment at Admission.

(1) Proposed Quality Measure 1: Hospice Visits When Death Is Imminent Measure Pair

Measure Background.

This measure set addresses whether a hospice patient and their caregivers' needs were addressed by the hospice staff during the last days of life. This measure is specified as a set of 2 measures. Measure 1 assesses the percentage of patients receiving at least 1 visit from registered nurses, physicians, nurse practitioners, or physician assistants in the last 3 days of life. Measure 2 assesses the percentage of patients receiving at least 2 visits from medical social workers, chaplains or spiritual counselors, licensed practical nurses, or hospice aides in the last 7 days of life. Measure 1 addresses case management and clinical care, while Measure 2 gives providers the flexibility to provide individualized care that is in line with the patient, family, and caregiver's preferences and goals for care and contributing to the overall well-being of the individual and others important in their life.

Measure Importance.

The last week of life is typically the period in the terminal illness trajectory with the highest symptom burden. Particularly during the last few days before death, patients experience myriad physical and emotional symptoms, necessitating close care and attention from the integrated hospice team. Hospice responsiveness during times of patient and caregiver need is an important aspect of care for hospice consumers. In addition, clinician visits to patients at the end of life have been demonstrated to be associated with improved outcomes such as decreased risk of hospitalization, emergency room visits, hospital deaths, decreased distress for caregivers, and higher satisfaction with care.

Several organizations and panels have identified care of the imminently dying patient as an important domain of palliative and hospice care and established guidelines and recommendations related to this high priority aspect of healthcare that affects a large number of people. The NQF 2006 report

A Framework for Preferred Practices for Palliative Care Quality

7

and the NCP Clinical Practice Guidelines for Quality Palliative Care

8

recommend that signs and symptoms of impending death are recognized, communicated and educated, and care appropriate for the phase of illness is provided. The American College of Physicians Clinical Practice Guidelines

9

recommend that clinicians regularly assess pain, dyspnea, and depression for patients with serious illness at the end of life. These measures address this high priority area by assessing hospice staff visits to patients and caregivers during the final days of life when patients and caregivers typically experience higher symptom and caregiving burdens, and therefore a higher need for care.

7

National Quality Forum.

A National Framework and Preferred Practices for Palliative and Hospice Care Quality.

2006; Available from:

http://www.qualityforum.org/publications/2006/12/A_National_Framework_and_Preferred_Practices_for_Palliative_and_Hospice_Care_Quality.aspx.

8

National Consensus Project,

Clinical Practice Guidelines for Quality Palliative Care. 3rd edition.

2013, National Consensus Project: Pittsburgh, PA.

9

Qaseem, A., et al.,

Evidence-Based Interventions to Improve the Palliative Care of Pain, Dyspnea, and Depression at the End of Life: A Clinical Practice Guideline from the American College of Physicians.

Annals of Internal Medicine, 2008. 148(2): p. 141-146.

Measure Impact.

The literature shows that health care providers' practice is responsive to quality measuring and reporting.

10

CMS feels this research, while not specific to hospices, reasonably predicts the effect of measures on hospice provider behavior. Collecting information about hospice staff visits for measuring quality of care, in addition to the requirement of reporting visits from some disciplines on hospice claims, will encourage hospices to visit patients and caregivers and provide services that will address their care needs and improve quality of life during the patients' last days of life.

10

Werner, R., E. Stuart, and D. Polsky,

Public reporting drove quality gains at nursing homes.

Health Affairs, 2010. 29(9): p. 1706-1713.

Performance Gap.

The 2014 Abt Medicare Hospice Payment Reform Report indicated that 28.9 percent of Routine Home Care hospice patients did not receive a skilled visit on the last day of life.

11

The Report defines a `skilled visit' as a visit from a nurse, social worker, or therapist. This percentage could be, in part, a result of rapid decline and unexpected death. The report revealed variation in receipt of visits at the end of life related to multiple factors. Patients who died on a weekday rather than a weekend, patients with a very short length of stay (5 days or less), and patients aged 84 and younger were more likely to receive a skilled visit in the last 2 days of life. Smaller hospices and hospices in operation for 5 years or less were slightly less likely to provide a visit at the end of life. States with the lowest rates of no visits in the last days of life were some of the more rural states (ND, WI, TN, KS, VT), whereas states with the highest rates of no visits were more urban (NJ, MA, OR, WA, MN).

11

Plotzke, M., et al.,

Medicare Hospice Payment Reform: Analyses to Support Payment Reform.

May 2014, Abt Associates Inc. Prepared for Centers for Medicare and Medicaid Services: Cambridge, MA.

Existing Measures.

This quality measure set will fill a gap by addressing hospice care provided at the end of life. No current HQRP measures address care beyond the hospice initial and comprehensive assessment period, nor do any current HQRP measures relate to the assessment of hospice staff visits to patients and caregivers in the last week of life.

Stakeholder Support.

A TEP convened by our measure development contractor, RTI International, on May 7 and 8, 2015, provided input on the measure concept. The TEP agreed that hospice visits when death is imminent is an important concept to measure and supported data collection using the HIS. A second TEP was convened October 19 and 21, 2015, to provide input on the technical specifications of this quality measure pair. The TEP supported development of a measure set rather than a single measure, using different timeframes to measure the different types of care provided, and limiting the measures to patients receiving routine home care. The NQF MAP met on December 14 and 15, 2015, and provided input to CMS. The MAP encouraged continued development of the Hospice Visits when Death is Imminent Measure Pair in the HQRP. More information about the MAP's recommendations for this measure is available at

http://www.qualityforum.org/ProjectMaterials.aspx?projectID=75370.

While this measure is not currently NQF endorsed, we recognize that the NQF endorsement process is an important part of measure development and plan to submit this measure pair for NQF endorsement.

Form, Manner, and Timing of Data Collection and Submission.

Data for this measure would be collected via the existing data collection mechanism, the HIS. CMS has proposed that 4 new items be added to the HIS-Discharge record to collect the necessary data elements for this measure. CMS expects that data collection for this quality

measure via the 4 new HIS items would begin no earlier than April 1, 2017. Thus, under current CMS timelines, hospice providers would begin data collection for this measure for patient admissions and discharges occurring after April 1, 2017. Prior to the release of the new HIS data items, CMS will provide education and training to hospice providers to ensure all providers have adequate information and guidance to collect and submit data on this measure to CMS.

Since the data collection mechanism is the HIS, providers would collect and submit data using the same processes that are outlined in sections III.C.7c through III.C.7e of this rule. In brief, processes in section III.C.7c through III.C.7e specify that data for the measure would be submitted to the Quality Improvement and Evaluation System (QIES) Assessment Submission and Processing (ASAP) system, in compliance with the timeliness criterion and threshold set out in sections III.C.7c through III.C.7e.

For more information on the specifications and data elements for the measure set, Hospice Visits when Death is Imminent, we refer readers to the HQRP Specifications for the Hospice Item Set-based Quality Measures document, available on the “Current Measures” portion of the CMS HQRP Web site:

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html.

In addition, to facilitate the reporting of HIS data as it relates to the implementation of the new measure, we submitted a request for approval to OMB for the Hospice Item Set version 2.00.0 under the Paperwork Reduction Act (PRA) process. The new HIS data items that would collect this measure data are also available for public viewing in the PRA package available at:

https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

We received multiple comments pertaining to the Hospice Visits when Death is Imminent Measure Pair. The following is a summary of the comments we received on this topic and our responses:

Comment:

We received many comments in support of our proposal to implement the Hospice Visits when Death is Imminent Measure Pair. Commenters emphasized the importance of visits at the end of life, and stated that this measure pair would provide a valuable measure of quality. Commenters also stated that they expect this measure will improve quality of life during patients' final days and that this measure could be useful to patients, families, and the Medicare program. One commenter said that hospice nurses are often aware when death is imminent because they are skilled at recognizing the final stages of a terminal condition, and that most individuals and families are aided and reassured by visits from some disciplines at the end of life.

Response:

We thank the commenters for their support of the Hospice Visits when Death is Imminent Measure Pair in the HQRP. We agree that visits at the end of life are an important component of hospice care and that this measure can help to drive holistic, patient centered quality improvement. We believe that this information will be useful to consumers, providers, and payers.

Comment:

Some commenters questioned whether the Hospice Visits when Death is Imminent Measure Pair would foster better quality for hospice care patients and requested evidence-based research showing the link between hospice visits and quality. One commenter emphasized the important role that hospices play in helping prepare patients and caregivers for the end of life, and stated that if hospices provide high quality preparation, then patients and families may need fewer visits at the end of life. The commenter stated that a focus on visits at the end of life may take focus away from empowering patients and caregivers. One commenter stated that, as a process measure, this measure pair does not adequately reflect high quality care, and urged CMS to conduct further testing of the measure. One commenter cautioned that, while sociodemographic differences in receipt of visits may appear to indicate differences in quality, one must also take into consideration possible differences in religious beliefs and cultural values that may affect desire for visits. One commenter noted that these measures alone might not be representative of the quality of care that hospice beneficiaries and their families receive.

Response:

We thank the commenters for their feedback. We are committed to the ensuring that all quality measures implemented in the HQRP meet the goals of the program, which include distinguishing performance among hospices and contributing to better patient outcomes.

We believe that provision of hospice visits at the end of life is an important component of high quality hospice care for most patients. The last week of life is typically the period in the terminal illness trajectory with the highest symptom burden and the literature supports hospice visits when death is imminent as a high priority in end-of-life care. Clinician visits to patients at the end of life have been demonstrated to be associated with improved outcomes such as decreased risk of hospitalization, emergency room visits, and hospital death; and higher satisfaction with care.

12

13

14

Measurements of visits at the end of life are already used in the literature as quality indicators for end of life or hospice care.

15

16

17

Studies focusing on the expectations of patients and families also demonstrate the importance of care and attention from the hospice team in the days leading up to death. Caregivers of dying patients agree overwhelmingly with the importance of preparation at the end of life. Hospice assistance, ranging from legal to logistical to emotional, is paramount in preparing hospice patients and their families for imminent death.

18

Bereaved family members and friends from a variety of settings identified the provision of physical comfort and emotional support to dying patients and their families as fundamental aspects of high-quality care.

19

12

Seow, H., Barbera, L., Howell, D., & Dy, S. M. (2010). Using more end-of-life homecare services is associated with using fewer acute care services: a population-based cohort study.

Med Care, 48

(2), 118-124. doi:10.1097/MLR.0b013e3181c162ef.

13

Almaawiy, U., Pond, G. R., Sussman, J., Brazil, K., & Seow, H. (2014). Are family physician visits and continuity of care associated with acute care use at end-of-life? A population-based cohort study of homecare cancer patients.

Palliat Med, 28

(2), 176-183. doi:10.1177/0269216313493125.

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Pivodic, L., Harding, R., Calanzani, N., McCrone, P., Hall, S., Deliens, L. & Gomes, B. (2015). Home care by general practitioners for cancer patients in the last 3 months of life: An epidemiological study of quality and associated factors.

Palliat Med.

doi:10.1177/0269216315589213.

15

Barbera, L., Seow, H., Sutradhar, R., Chu, A., Burge, F., Fassbender, K., . . . Potapov, A. (2015). Quality Indicators of End-of-Life Care in Patients With Cancer: What Rate Is Right?

J Oncol Pract, 11

(3), e279-287. doi:10.1200/jop.2015.004416.

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Gandhi, S. O. (2012). Differences between non-profit and for-profit hospices: patient selection and quality.

Int J Health Care Finance Econ, 12

(2), 107-127. doi:10.1007/s10754-012-9109-y.

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Lorenz, K. A., Ettner, S. L., Rosenfeld, K. E., Carlisle, D. M., Leake, B., & Asch, S. M. (2002). Cash and compassion: profit status and the delivery of hospice services.

J Palliat Med, 5

(4), 507-514. doi:10.1089/109662102760269742.

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Steinhauser, K. E., Christakis, N. A., Clipp, E. C., McNeilly, M., McIntyre, L., & Tulsky, J. A. (2000). Factors considered important at the end of life by patients, family, physicians, and other care providers.

Jama, 284

(19), 2476-2482.

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Steinhauser, K. E., Christakis, N. A., Clipp, E. C., McNeilly, M., McIntyre, L., & Tulsky, J. A. (2000). Factors considered important at the end of life by patients, family, physicians, and other care providers.

Jama, 284

(19), 2476-2482.

The literature shows that health care providers' practices are responsive to

quality measurement and reporting.

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We believe that this research, while not specific to hospices, reasonably predicts the effect of measures on hospice provider behavior. Collecting information about hospice staff visits for measuring quality of care, in addition to the requirement of reporting visits from some disciplines on hospice claims, will encourage hospices to visit patients and caregivers and provide services that will address their care needs and improve quality of life during the patients' last days of life. While we agree that a greater number of visits does not always indicate higher quality care, based on the published literature and expert input, we believe that most patients benefit from some visits near the end of life. For this reason, this measure set is specified to measure receipt of at least 1 clinician visit (Measure 1) and at least 2 visits from other staff (Measure 2), rather than measuring the total number of visits. A TEP held in October 19 and 21, 2015, by our contractor agreed that a measure of patients receiving at least a minimum number of visits would be a better indicator of quality than a measure of the total number of visits provided.

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Werner, R., E. Stuart, and D. Polsky, Public reporting drove quality gains at nursing homes.

Health Affairs

, 2010. 29(9): p. 1706-1713.

We agree with the commenter that this measure pair alone may not provide a full representation of the quality of care that hospices provide. The previously finalized measures in the HQRP address care processes at admission, and the Hospice CAHPS survey examines caregiver experience retrospectively. This measure pair fills an important gap in the HQRP by providing a measure of quality of care provided near the time of death, and it is intended to be interpreted along with the other measures in the HQRP to reflect quality of care provided by hospices across several domains of care that are important to patients and other stakeholders. CMS also plans to analyze the relationship between this quality measure pair and other quality measures to support the validity of this measure pair (that is, the measure reflects true quality of care).

Comment:

One commenter expressed concern that the results of the Hospice Visits when Death is Imminent Measure Pair may be mischaracterized once they are publicly reported, if appropriate disclaimers are absent from the information provided. Another commenter requested that CMS remind measure users that patients/families have the right to decline services and that those declinations should not be considered an “under-service” by the hospice provider.

Response:

We thank the commenters for their feedback regarding interpreting these measures. We agree that it is important to educate both providers and consumers on how to use and interpret these quality measures. Prior to public reporting of this measure, we will provide resources through the Hospice Compare Web site to aid consumers in interpreting the quality metrics reported there. CMS has carefully considered usability by consumers throughout the measure development process. The measure specifications take into account usability feedback from a TEP, caregiver workgroup, and clinical user panel. We recognize that some patients may decline services and that rapid and unanticipated patient declines do occur; thus, a score of 100% is not the expectation for this measure pair.

Comment:

Some commenters stated that it is not always known when a patient's death is imminent. One commenter stated that there is not always an opportunity for hospices to provide the visits specified in this measure set if a patient experiences a rapid and unanticipated decline.

Response:

We understand that it is not always possible to accurately predict time of death. However, the last week of life is typically the period in the terminal illness trajectory with the highest symptom burden, especially during the last few days before death. We recognize that rapid and unanticipated patient declines do occur; thus, a score of 100 percent is not the expectation for this measure pair. We do expect that hospices delivering high quality care will be responsive to the patient and caregiver needs that arise during the last days of a patient's life. In order to address performance gaps in this measure, providers may be motivated to proactively assess symptom burden, resulting in improved symptom management and higher quality of life during the final days.

Comment:

We received some comments related to the structure of the Hospice Visits when Death is Imminent Measure Pair and intent of each measure. Some comments indicated that commenters might have misinterpreted the intent of this measure pair. For example, one commenter stated that adoption of this measure pair would in fact create three visit metrics, and another commenter referenced the calculation of a composite measure for visits at the end of life. Some commenters interpreted the specifications as not including visits addressing spiritual or psychosocial suffering in the 3 days before death.

Some commenters requested clarification of the calculation of each of these measures and of the disciplines included in each. One commenter recommended that Measure 1 and Measure 2 be combined into one measure in order to streamline data collection. One commenter requested that RN visits be included in both Measure 1 and Measure 2 since some interventions to manage symptoms may only be provided by an RN.

Response:

We wish to clarify the intent of this measure pair. The Hospice Visits when Death is Imminent Measure Pair will be calculated and reported as two separate measures. These measures are intended to be interpreted as a set. For more information on the specifications and data elements for the measure set, Hospice Visits when Death is Imminent Measure Pair, we refer readers to the HQRP Specifications for the Hospice Item Set-based Quality Measures document, available on the “Current Measures” portion of the CMS HQRP Web site:

https://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/HospiceQuality-Reporting/CurrentMeasures.html.

The two measures are intended to capture distinct aspects of hospice care at the end of life. The inclusion of registered nurses, physicians, nurse practitioners, and physician assistants in Measure 1 is intended to capture the range of clinical disciplines that might visit a patient, depending on patient and hospice preferences, and uses a 3-day timeframe to reflect the active dying phase. The inclusion of medical social workers, chaplains or spiritual counselors, licensed practical nurses, and hospice aides in Measure 2 is intended to allow for flexible and individualized care in line with patient, family, and caregiver preferences. The 7-day time frame covers both the active dying phase and the transition period before, and thus could also capture important visits related to preparation for active dying. To clarify, the 7-day time frame is inclusive of the 3 days prior to death. Data collection is conducted at the discipline level in order to provide us with sufficient information to conduct reliability and validity testing and possible future measure refinement.

Comment:

We received some comments regarding the types of visits included in the Hospice Visits when Death is Imminent Measure Pair. Some commenters requested that all visits on the date of death be included in the measures, including postmortem visits, as this is an important service that hospices provide. One commenter

recommended that a new, separate measure could look at postmortem visits. Some commenters requested that phone calls or videoconferencing be included in the measures. One commenter stated that phone calls may be an especially important form of contact in rural areas. A few commenters requested clarification of the definition of a visit counted for quality purposes, and one inquired what visit duration is expected.

Response:

We thank the commenters for their feedback regarding the types of visits included in this measure pair. We agree that post mortem and bereavement visits are an important service for hospices to provide. However, we believe that these services are outside the scope of this quality measure pair, which focusses specifically on visits when death is imminent. These visits provided shortly prior to death are intended to address the increased symptom burden many patients experience when death is imminent and provide an opportunity for proactive assessment and communication.

We recognize that some providers use phone calls to supplement care provided in person and that these calls can be helpful in facilitating ongoing care and communication. However, in agreement with a TEP and based on the available evidence, we consider these calls as a supplement to, and not a replacement for, in-person care, particularly when death is imminent. For this reason, phone calls are not included in the definition of a visit for this measure pair. Prior to implementation of the HIS V2.00.0, we will provide hospices with guidance and training materials, including an updated version of the HIS Manual. These training materials will further clarify the types of visits included in this measure pair and other item coding information.

Comment:

We received many comments regarding the disciplines included in each of the Hospice Visits when Death is Imminent measures. One commenter stated that this measure pair recognizes the value of the core interdisciplinary team members and maintains a holistic approach to care. Many commenters supported the inclusion of chaplains or spiritual counselors and aides in Measure 2, as they play an important role in the interdisciplinary team. Some commenters encouraged CMS to conduct further research on the types of visits provided at the end of life and present a clear rationale for inclusion or exclusion from this measure. One commenter recommended that both measures be amended to include any member of the hospice's interdisciplinary team.

Many commenters requested that visits from volunteers be included in Measure 2. The commenters pointed out that the use of volunteers is a Medicare requirement for hospices, and that volunteers play an important role in the delivery of hospice care. One commenter indicated that it might be burdensome to report data on volunteer visits, but that inclusion of volunteers would be valuable. A couple of commenters requested that visits from music therapists or massage therapists be included in Measure 2.

Several commenters noted that although physician assistant (PA) visits are included in this quality measure pair, this discipline is not identified by CMS as a core or non-core service of a hospice provider. Some of these commenters requested that PA visits be removed from the measure in order to align with the Conditions of Participation and Medicare payment practices. Some of these commenters supported the inclusion of PAs and recommended that their role be clarified. One commenter stated that since the use of PAs is limited, inclusion of PA visits would negatively skew the data.

One commenter noted that a Licensed Practicing Nurse's (LPN) scope of practice varies from state to state, and asked that CMS consider removing LPN visits from the measure to make the measure more uniform nation-wide. One commenter expressed appreciation for the inclusion of LPNs and stated that the discipline is frequently used.

Some commenters requested that bereavement coordinator or bereavement counselor visits be included in this measure pair. One commenter requested clarification of whether a visit from a provider contracted but not employed by a hospice program would be considered a visit under this measure pair.

Response:

We thank the commenters for their support of the disciplines included in this measure, including chaplains or spiritual counselors and aides. This measure pair is designed to allow hospices flexibility to determine the most appropriate discipline or disciplines to visit a patient. The inclusion of registered nurses, physicians, nurse practitioners, and physician assistants in Measure 1 is intended to capture the range of clinical disciplines that might visit a patient, depending on patient and family preferences and emerging care needs in the last days of life. Similarly, the inclusion of medical social workers, chaplains or spiritual counselors, licensed practical nurses, and hospice aides in Measure 2 is intended to allow for flexible and individualized care in line with patient, family, and caregiver preferences. This measure is not intended to require visits from any given discipline, but aims to allow flexibility in the types of visits provided. The Hospice Conditions of Participation state that the interdisciplinary group must include, but is not limited to, a doctor of medicine or osteopathy, a registered nurse, a social worker, and a pastoral or other counselor. Visits from all of these disciplines are included in this measure pair, as well as from some additional disciplines. We have carefully researched the topic of which disciplines to include in this measure pair, including an environmental scan, pilot test of this measure in summer 2015, TEP discussions on May 7 and 8, 2015, and October 19 and 21, 2015, and input from our Clinical Users Panel and Caregiver Workgroup.

Regarding volunteer visits, we agree that volunteers play an important role in high quality hospice care and that their visits are important to patients and families. Visits from volunteers were included in an early version of this measure, which pilot tested for feasibility in summer 2015. Many of the hospices included in the pilot had trouble reporting data on visits from volunteers because the records of volunteer visits were often stored in a separate system and were frequently delayed. The data was unreliable, and hospices reported significant reporting burden. This topic was discussed with the TEP, held October 19 and 21, 2015. After reviewing the results from the pilot test and thoroughly discussing the issues, the TEP members did not support including visits from volunteers in this measure pair. For the same reasons, the TEP advised against including complementary and alternative therapists such as music or massage therapists in this measure pair, though they do provide important services.

Regarding physician assistant visits, although Medicare does not provide separate payments for visits from physician assistants, these services would be covered under the hospice per diem. Additionally, this measure is an all-payer measure and some states and other programs may authorize physician assistants to provide hospice care under separate payments. This measure pair is separate from payment and should focus on services provided by hospices and not be restricted by the terms of payment by Medicare. Therefore, the inclusion of physician assistants in the

measure specifications provides the flexibility for hospices that may have physician assistants to count these clinical visits as part of Measure 1. We wish to clarify that the absence of physician assistant visits will not negatively skew the data reported in this measure. Visits from physician assistants are one of the options included in Measure 1, but patients will also be included in the numerator of the measure if they receive a visit from a registered nurse, physician, or nurse practitioner.

We thank the commenters for their feedback regarding the inclusion of LPNs in Measure 2. Members of our TEP agreed that LPNs provide an important service in hospice care that is distinct from the role of RNs. For this reason, we have included visits from LPNs in Measure 2 of this measure pair.

We appreciate the commenters' recommendations to include bereavement coordinators, and agree that visits from these disciplines are important for many patients and families. However, we believe that bereavement services are outside the scope of this quality measure pair, which focusses specifically on visits, which may address the increased symptom burden many patients experience when death is imminent, and provide an opportunity for proactive assessment and communication.

Regarding contracted hospice staff, we clarify that visits from contracted staff may be included in this measure pair. As defined in the HIS Manual V1.02, hospice staff members may include volunteers, contractors, and affiliates.

Comment:

Some commenters recommended changes to the Hospice Visits when Death is Imminent Measure Pair to further align the two measures. A few commenters sugge

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