Medicare Program; FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements, 25497-25538 [2016-09631]

Download as PDF Vol. 81 Thursday, No. 82 April 28, 2016 Part II Department of Health and Human Services mstockstill on DSK3G9T082PROD with PROPOSALS2 Centers for Medicare & Medicaid Services 42 CFR Part 418 Medicare Program; FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements; Proposed Rule VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\28APP2.SGM 28APP2 25498 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 418 [CMS–1652–P] RIN 0938–AS79 Medicare Program; FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. AGENCY: This proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2017. In addition, this rule proposes changes to the hospice quality reporting program, including proposing new quality measures. The proposed rule also solicits feedback on an enhanced data collection instrument and describes plans to publicly display quality measures and other hospice data beginning in the middle of 2017. Finally, this proposed rule includes information regarding the Medicare Care Choices Model (MCCM). DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on June 20, 2016. ADDRESSES: In commenting, please refer to file code CMS–1652–P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the ‘‘Submit a comment’’ instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–1652– P, P.O. Box 8010, Baltimore, MD 21244– 8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–1652– P, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850. mstockstill on DSK3G9T082PROD with PROPOSALS2 SUMMARY: VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period: a. For delivery in Washington, DC— Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445–G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD— Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244–1850. If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786–9994 in advance to schedule your arrival with one of our staff members. Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. 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. For general questions about hospice payment policy, please send your inquiry via email to: hospicepolicy@cms.hhs.gov. Wage index addenda will be available only through the internet on the CMS Web site at: (https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ Hospice/.) Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: https:// SUPPLEMENTARY INFORMATION: PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 www.regulations.gov. Follow the search instructions on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1–800–743–3951. 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 Proposed Rule A. Monitoring for Potential Impacts— Affordable Care Act Hospice Reform 1. Hospice Payment Reform: Research and Analyses a. Pre-Hospice Spending b. Non-Hospice Spending c. Live Discharge Rates d. Skilled Visits in the Last Days of Life 2. Monitoring for Impacts of Hospice Payment Reform B. Proposed FY 2017 Hospice Wage Index and Rates Update 1. Proposed FY 2017 Hospice Wage Index a. Background b. FY 2016 Implementation of New Labor Market Delineations 2. Proposed FY 2017 Hospice Payment Update Percentage 3. Proposed FY 2017 Hospice Payment Rates 4. Hospice Cap Amount for FY 2017 C. Proposed 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 E:\FR\FM\28APP2.SGM 28APP2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules mstockstill on DSK3G9T082PROD with PROPOSALS2 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 proposed 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 BETOS Berenson-Eggers Types of Service BIPA Benefits Improvement and Protection Act of 2000 VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 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 HIPPA 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 PostAcute Care Transformation Act of 2014 IOM Institute of Medicine IPPS Inpatient Prospective Payment System IRC Inpatient Respite Care LCD Local Coverage Determination 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 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 25499 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 for this Proposed Rule A. Purpose This rule proposes updates to 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 proposes 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 proposed 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 Section III.A of this proposed rule describes current trends in hospice utilization and provider behavior, as well as our efforts for monitoring potential impacts related to the hospice reform policies finalized in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47142). In section III.B.1 of this proposed rule, we propose to update the hospice wage index with updated wage data and to 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 E:\FR\FM\28APP2.SGM 28APP2 25500 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules payment update percentage of 2.0 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 proposed rule, we discuss updates to HQRP, including the proposal of 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 proposed measures would 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 potential 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 would 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 offers 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 mstockstill on DSK3G9T082PROD with PROPOSALS2 TABLE 1—IMPACT SUMMARY Provision description Transfers FY 2017 Hospice Wage Index and Payment Rate Update. The overall economic impact of this proposed rule is estimated to be $330 million in increased payments to hospices during FY 2017. VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 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 familycentered 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. See also 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 lifethreatening 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 team 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. PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 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 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, shortterm, 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, E:\FR\FM\28APP2.SGM 28APP2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules 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 entitled ‘‘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. 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 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. mstockstill on DSK3G9T082PROD with PROPOSALS2 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 https://www.hhs.gov/ ocr/civilrights. VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 25501 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); shortterm inpatient care in a hospital, nursing facility, or hospice inpatient facility (including both respite care and procedures necessary for pain control and acute or chronic symptom management); continuous home care during periods of crisis, and only as necessary to maintain the terminally ill individual at home; and any other item or service which is specified in the plan of care and for which payment may otherwise be made under Medicare, in accordance with Title XVIII of the Act. Section 1814(a)(7)(B) of the Act requires that a written plan for providing hospice care to a beneficiary who is a hospice patient be established before care is provided by, or under arrangements made by, that hospice program and that the written plan be periodically reviewed by the beneficiary’s attending physician (if any), the hospice medical director, and E:\FR\FM\28APP2.SGM 28APP2 mstockstill on DSK3G9T082PROD with PROPOSALS2 25502 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules an interdisciplinary group (described in section 1861(dd)(2)(B) of the Act). The services offered under the Medicare hospice benefit must be available to beneficiaries as needed, 24 hours a day, 7 days a week (section 1861(dd)(2)(A)(i) of the Act). Upon the implementation of the hospice benefit, the Congress 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, the 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 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 VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 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 fiscal year 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. PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 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 prereclassified 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 E:\FR\FM\28APP2.SGM 28APP2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules mstockstill on DSK3G9T082PROD with PROPOSALS2 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 VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 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, the Congress included an aggregate cap on hospice payments, which limits the total aggregate payments any individual hospice can receive in a year. The 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, within certain limits. We allowed existing hospices the option of having their cap calculated via the original streamlined methodology, also within certain limits. As of FY 2012, new hospices have their cap determinations calculated using the patient-by-patient proportional methodology. 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 PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 25503 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 E:\FR\FM\28APP2.SGM 28APP2 25504 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules 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 mstockstill on DSK3G9T082PROD with PROPOSALS2 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 fiscal year 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. 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. 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. 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, symptomclassified 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 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 claimsreported principal diagnosis codes reported in FY 2015 (see Table 2). 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 ................... 2 ................... 3 ................... VerDate Sep<11>2014 162.9 428.0 799.3 Lung Cancer ..................................................................................................................... Congestive Heart Failure .................................................................................................. Debility Unspecified .......................................................................................................... 21:19 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 E:\FR\FM\28APP2.SGM 28APP2 73,769 45,951 36,999 11 7 6 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules 25505 TABLE 2—THE TOP TWENTY PRINCIPAL HOSPICE DIAGNOSES, FY 2002, FY 2007, FY 2013, FY 2015—Continued Rank ICD–9/reported principal diagnosis Count 4 ................... 5 ................... 6 ................... 7 ................... 8 ................... 9 ................... 10 ................. 11 ................. 12 ................. 13 ................. 14 ................. 15 ................. 16 ................. 17 ................. 18 ................. 19 ................. 20 ................. 496 COPD ................................................................................................................................... 331.0 Alzheimer’s Disease ......................................................................................................... 436 CVA/Stroke .......................................................................................................................... 185 Prostate Cancer ................................................................................................................... 783.7 Adult Failure To Thrive ..................................................................................................... 174.9 Breast Cancer ................................................................................................................... 290.0 Senile Dementia, Uncomp ................................................................................................ 153.0 Colon Cancer .................................................................................................................... 157.9 Pancreatic Cancer ............................................................................................................ 294.8 Organic Brain Synd Nec ................................................................................................... 429.9 Heart Disease Unspecified ............................................................................................... 154.0 Rectosigmoid Colon Cancer ............................................................................................. 332.0 Parkinson’s Disease ......................................................................................................... 586 Renal Failure Unspecified ................................................................................................... 585 Chronic Renal Failure (End 2005) ....................................................................................... 183.0 Ovarian Cancer ................................................................................................................. 188.9 Bladder Cancer ................................................................................................................. Percentage 35,197 28,787 26,897 20,262 18,304 17,812 16,999 16,379 15,427 10,394 10,332 8,956 8,865 8,764 8,599 7,432 6,916 5 4 4 3 3 3 3 2 2 2 2 1 1 1 1 1 1 90,150 86,954 77,836 60,815 58,303 58,200 37,667 31,800 22,170 22,086 20,378 19,082 19,080 17,697 16,524 15,777 12,188 11,196 8,806 8,434 9 8 7 6 6 6 4 3 2 2 2 2 2 2 2 2 1 1 1 1 127,415 96,171 91,598 82,184 79,626 71,122 60,579 36,914 34,459 30,963 25,396 23,228 23,224 23,059 22,341 21,769 19,309 15,965 14,372 13,687 9 7 6 6 6 5 4 3 2 2 2 2 2 2 2 2 1 1 1 1 195,469 114,240 87,661 80,081 46,610 34,734 13 8 6 5 3 2 Year: FY 2007 1 ................... 2 ................... 3 ................... 4 ................... 5 ................... 6 ................... 7 ................... 8 ................... 9 ................... 10 ................. 11 ................. 12 ................. 13 ................. 14 ................. 15 ................. 16 ................. 17 ................. 18 ................. 19 ................. 20 ................. 799.3 Debility Unspecified .......................................................................................................... 162.9 Lung Cancer ..................................................................................................................... 428.0 Congestive Heart Failure .................................................................................................. 496 COPD ................................................................................................................................... 783.7 Adult Failure To Thrive ..................................................................................................... 331.0 Alzheimer’s Disease ......................................................................................................... 290.0 Senile Dementia Uncomp. ................................................................................................ 436 CVA/Stroke .......................................................................................................................... 429.9 Heart Disease Unspecified ............................................................................................... 185 Prostate Cancer ................................................................................................................... 174.9 Breast Cancer ................................................................................................................... 157.9 Pancreas Unspecified ......................................................................................................... 153.9 Colon Cancer .................................................................................................................... 294.8 Organic Brain Syndrome NEC ............................................................................................ 332.0 Parkinson’s Disease ......................................................................................................... 294.10 Dementia In Other Diseases w/o Behav. Dist ................................................................ 586 Renal Failure Unspecified ................................................................................................... 585.6 End Stage Renal Disease ................................................................................................ 188.9 Bladder Cancer ................................................................................................................. 183.0 Ovarian Cancer ................................................................................................................. mstockstill on DSK3G9T082PROD with PROPOSALS2 Year: FY 2013 1 ................... 2 ................... 3 ................... 4 ................... 5 ................... 6 ................... 7 ................... 8 ................... 9 ................... 10 ................. 11 ................. 12 ................. 13 ................. 14 ................. 15 ................. 16 ................. 17 ................. 18 ................. 19 ................. 20 ................. 799.3 Debility Unspecified .......................................................................................................... 428.0 Congestive Heart Failure .................................................................................................. 162.9 Lung Cancer ..................................................................................................................... 496 COPD ................................................................................................................................... 331.0 Alzheimer’s Disease ......................................................................................................... 783.7 Adult Failure to Thrive ...................................................................................................... 290.0 Senile Dementia, Uncomp ................................................................................................ 429.9 Heart Disease Unspecified ............................................................................................... 436 CVA/Stroke .......................................................................................................................... 294.10 Dementia In Other Diseases w/o Behavioral Dist. ......................................................... 332.0 Parkinson’s Disease ......................................................................................................... 153.9 Colon Cancer .................................................................................................................... 294.20 Dementia Unspecified w/o Behavioral Dist. ................................................................... 174.9 Breast Cancer ................................................................................................................... 157.9 Pancreatic Cancer ............................................................................................................ 185 Prostate Cancer ................................................................................................................... 585.6 End-Stage Renal Disease ................................................................................................ 518.81 Acute Respiratory Failure ............................................................................................... 294.8 Other Persistent Mental Dis.-classified elsewhere ........................................................... 294.11 Dementia In Other Diseases w/Behavioral Dist. ............................................................ Year: FY 2015 1 2 3 4 5 6 ................... ................... ................... ................... ................... ................... VerDate Sep<11>2014 331.0 Alzheimer’s disease .......................................................................................................... 428.0 Congestive heart failure, unspecified ............................................................................... 162.9 Lung Cancer ..................................................................................................................... 496 COPD ................................................................................................................................... 331.2 Senile degeneration of brain ............................................................................................ 332.0 Parkinson’s Disease ......................................................................................................... 21:19 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 E:\FR\FM\28APP2.SGM 28APP2 25506 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules TABLE 2—THE TOP TWENTY PRINCIPAL HOSPICE DIAGNOSES, FY 2002, FY 2007, FY 2013, FY 2015—Continued Rank ICD–9/reported principal diagnosis Count 7 ................... 8 ................... 9 ................... 10 ................. 11 ................. 12 ................. 13 ................. 14 ................. 15 ................. 16 ................. 17 ................. 18 ................. 19 ................. 20 ................. 429.9 Heart disease, unspecified ............................................................................................... 436 CVA/Stroke .......................................................................................................................... 437.0 Cerebral atherosclerosis ................................................................................................... 174.9 Breast Cancer ................................................................................................................... 153.9 Colon Cancer .................................................................................................................... 185 Prostate Cancer ................................................................................................................... 157.9 Pancreatic Cancer ............................................................................................................ 585.6 End stage renal disease ................................................................................................... 491.21 Obstructive chronic bronchitis with (acute) exacerbation ............................................... 518.81 Acute respiratory failure .................................................................................................. 429.2 Cardiovascular disease, unspecified ................................................................................ 434.91 Cerebral artery occlusion, unspecified with cerebral infarction ...................................... 414.00 Coronary atherosclerosis of unspecified type of vessel ................................................. 188.9 Bladder Cancer ................................................................................................................. Percentage 31,695 28,985 26,765 23,742 23,677 23,061 22,906 22,763 21,283 19,965 16,843 15,642 15,566 11,517 2 2 2 2 2 2 2 2 1 1 1 1 1 1 mstockstill on DSK3G9T082PROD with PROPOSALS2 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 preliminary FY 2015 hospice claims data from the CCW, accessed on January 25, 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. Preliminary 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.3 3 FFY15 Hospice Claims from CCW; Pulled Jan 06 2016 VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 F. Use of Health Information Technology 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. The Department of Health and Human Services (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/nationwideinteroperability-roadmap-final-version1.0.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 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 specifications. The 2015 Edition also focuses on the establishment of an interoperable nationwide health information infrastructure. More information on the ONC Health IT Certification Program is available at: https://www.healthit.gov/policyresearchers-implementers/2015-editionfinal-rule III. Provisions of the Proposed Rule A. Monitoring for Potential Impacts— Affordable Care Act Hospice Reform 1. Hospice Payment Reform: Research and Analyses a. Pre-Hospice Spending In 1982, the Congress introduced hospice into the Medicare program as an alternative to aggressive curative treatment at the end of life. During the development of the benefit, multiple testimonies from industry leaders and hospice families were heard, and it was consistently reported that hospices provided high-quality, compassionate and humane care while also offering a reduction in Medicare costs.4 Additionally, a Congressional Budget Office (CBO) study asserted that hospice care would result in sizable savings over conventional hospital care.5 Those savings estimates were based on a comparison of spending in the last 6 months of life for a cancer patient not utilizing hospice care versus the cost of hospice care for the 6 months preceding 4 Subcommittee of Health of the Committee of Ways and Means, House of Representatives, March 25, 1982. 5 Mor V. Masterson-Allen S. (1987): Hospice care systems: Structure, process, costs and outcome. New York: Springer Publishing Company. E:\FR\FM\28APP2.SGM 28APP2 25507 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules death.6 Therefore, the original language for section 1814(i) of the Act (prior to August 29, 1983) set the hospice aggregate cap amount at 40 percent of the average Medicare per capita expenditure amount for cancer patients in the last 6 months of life. Recent analysis conducted by MedPAC showed that hospice appears to modestly raise end-of-life costs.7 While hospice reduces costs for cancer decedents on average, hospice does not reduce costs for individuals with long hospice stays. Analysis was conducted to evaluate pre-hospice spending for beneficiaries who used hospice and who died in FY 2014. To evaluate pre-hospice spending, we calculated the median daily Medicare payments for such beneficiaries for the 180 days, 90 days, and 30 days prior to electing hospice care. We then categorized patients according to the principal diagnosis reported on the hospice claim. The analysis revealed that for some patients, the Medicare payments in the 180 days prior to the hospice election were lower than Medicare payments associated with hospice care once the benefit was elected (see Table 3). Specifically, median Medicare spending for a beneficiary with a diagnosis of Alzheimer’s disease, non-Alzheimer’s dementia, or Parkinson’s in the 180 days prior to hospice admission (about 20 percent of patients) was $64.87 per day compared to the daily RHC rate of $156.06 in FY 2014. Closer to hospice admission, the median Medicare payments per day increase, as would be expected as the patient approaches the end of life and patient needs intensify. However, 30 days prior to a hospice election, median Medicare spending was $96.99 for patients with Alzheimer’s disease, non-Alzheimer’s dementia, or Parkinson’s. In contrast, the median Medicare payments prior to hospice election for patients with a principal hospice diagnosis of cancer were $143.48 in the 180 days prior to hospice admission and increased to $293.64 in the 30 days prior to hospice admission. The average length of stay for hospice elections where the principal diagnosis was reported as Alzheimer’s disease, non-Alzheimer’s Dementia, or Parkinson’s is greater than patients with other diagnoses, such as cancer, Cerebral Vascular Accident (CVA)/stroke, chronic kidney disease, and Chronic Obstructive Pulmonary Disease (COPD). For example, the average lifetime length of stay for an Alzheimer’s, non-Alzheimer’s Dementia, or Parkinson’s patient in FY 2014 was 119 days, compared to 47 days for patients with a principal diagnosis of cancer (or in other words, 150 percent longer). TABLE 3—MEDIAN PRE-HOSPICE SPENDING ESTIMATES AND INTERQUARTILE RANGE BASED ON 180, 90, AND 30 DAY LOOK-BACK PERIODS PRIOR TO INITIAL HOSPICE ADMISSION WITH ESTIMATES OF AVERAGE LIFETIME LENGTH OF STAY (LOS) BY PRIMARY DIAGNOSIS AT HOSPICE ADMISSION, FY 2014 Estimates of Daily Non-Hospice Medicare Spending Prior to First Hospice Admission Primary Hospice Diagnosis at Admission 180 Day Look-Back 90 Day Look-Back 25th Pct. All Diagnoses ............................... Alzheimer’s, Dementia, and Parkinson’s ..................................... CVA/Stroke ................................... Cancers ........................................ Chronic Kidney Disease ............... Heart (CHF and Other Heart Disease) ......................................... Lung (COPD and Pneumonias) ... All Other Diagnoses ..................... Median 75th Pct. $46.92 $117.77 22.56 51.05 62.37 87.81 57.03 63.10 44.75 30 Day Look-Back 25th Pct. Median 75th Pct. $241.97 $55.70 $157.92 64.87 111.22 143.48 203.97 160.29 233.33 268.44 389.33 22.16 70.13 77.91 117.38 130.15 140.46 115.05 251.14 268.43 245.91 72.85 87.05 54.25 Mean Lifetime Total Hospice Days 25th Pct. Median 75th Pct. $340.24 $58.07 $268.98 $548.00 73.9 78.62 158.29 188.66 273.72 216.75 338.67 364.64 524.18 20.18 102.64 80.81 174.13 96.99 320.20 293.64 435.90 357.49 588.60 576.16 796.26 118.8 55.6 47.3 29.8 177.45 196.62 158.65 357.43 396.02 357.24 84.57 114.58 59.98 308.69 360.29 285.65 572.53 676.46 590.73 78.8 69.4 78.2 mstockstill on DSK3G9T082PROD with PROPOSALS2 Source: All Medicare Parts A, B, and D claims for FY 2014 from the Chronic Conditions Data Warehouse (CCW) retrieved February, 2016. Note(s): Estimates drawn from FY2014 hospice decedents who were first-time hospice admissions, ages 66+ at hospice admission, admitted since 2006, and not enrolled in Medicare Advantage prior to admission. All payments are inflation-adjusted to September 2014 dollars using the Consumer Price Index (Medical Care; All Urban Consumers). In the FY 2014 Hospice Wage Index and Payment Rate Update proposed and final rules (78 FR 27843 and 78 FR 48272, respectively), we discussed whether a case mix system could be created in future refinements to differentiate hospice payments according to patient characteristics. Analyzing pre-hospice spending was undertaken as an initial step in determining whether patients required different resource needs prior to hospice based on the principal diagnosis reported on the hospice claim. Table 3 indicates that hospice patients with the longest length of stay had lower prehospice spending relative to hospice patients with shorter lengths of stay. These hospice patients tend to be those with neurological conditions, including those with Alzheimer’s disease, other related dementias, and Parkinson’s disease. Typically, these conditions are associated with longer disease trajectories, progressive loss of functional and cognitive abilities, and more difficult prognostication. b. Non-hospice Spending 6 Fogel, Richard. (1983): Comments on the Legislative Intent of Medicare’s Hospice Benefit (GAO/HRD–83–72). 7 Hogan, C. (2015): Spending in the Last Year of Life and the Impact of Hospice on Medicare Outlays. https://www.medpac.gov/documents/ contractor-reports/spending-in-the-last-year-of-lifeand-the-impact-of-hospice-on-medicare-outlays(updated-august-2015).pdf?sfvrsn=0 VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 When a beneficiary elects the Medicare hospice benefit, he or she waives the right to Medicare payment for services related to the treatment of the individual’s condition with respect to which a diagnosis of terminal illness has been made, except for services provided by the designated hospice and the attending physician. Hospice services are to be comprehensive and inclusive and we have reiterated since 1983 that ‘‘virtually all’’ care needed by the terminally ill individual would be provided by hospice, given the E:\FR\FM\28APP2.SGM 28APP2 25508 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules hospice election in the FY 2015 Hospice Wage Index and Payment Rate Update final rule (79 FR 50452) and FY 2013 non-hospice spending during a hospice election in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47153). In this rule, we updated our analysis of non-hospice spending during a hospice election using FY 2014 data. Medicare payments for non-hospice Part A and Part B services received by hospice beneficiaries during hospice election were $710.1 million in CY 2012, $694.1 million in FY 2013, and $600.8 million in FY 2014 (See Figure 1). Non-hospice spending has decreased each year since we began reporting these findings: down 2.2 percent from CY 2012 to FY 2013 and then down 13.4 percent in from FY 2013 to FY 2014—a much more significant decline. Overall, from CY 2012 to FY 2014 non-hospice spending during hospice election declined 15.4 percent. Hospice beneficiaries had $122.5 million in Parts A and B cost-sharing for items and services that were billed to Medicare Parts A and B for a total of $723.3 million for FY 2014. We also examined Part D for CY 2012 and FY 2013 spending for those beneficiaries under a hospice election and reported those findings in our FY 2015 and FY 2016 hospice final rules, respectively. We updated our analysis of FY 2014 Part D Prescription Drug Event data, which shows Medicare payments for non-hospice Part D drugs received by hospice beneficiaries during a hospice election were $334.9 million in CY 2012, $347.1 million in FY 2013, and $291.6 million in FY 2014 (see Figure 2). VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 E:\FR\FM\28APP2.SGM 28APP2 EP28AP16.003</GPH> mstockstill on DSK3G9T082PROD with PROPOSALS2 interrelatedness of body systems. We believe that it would be unusual and exceptional to see services provided outside of hospice for those individuals who are approaching the end of life. However, we have conducted ongoing analysis of non-hospice spending during a hospice election over the past several years and this analysis seems to suggest unbundling of services that perhaps should have been provided and covered under the Medicare hospice benefit. We reported initial findings on CY 2012 non-hospice spending during a Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules Table 4 details the various components of Part D spending for patients receiving hospice care. The portion of the $371.7 million total Part D spending that was paid by Medicare is the sum of the Low Income CostSharing Subsidy and the Covered Drug Plan Paid Amount, or $291.6 million. TABLE 4—DRUG COST SOURCES FOR HOSPICE BENEFICIARIES’ FY 2014 DRUGS RECEIVED THROUGH PART D Patient Pay Amount ................ Low Income Cost-Sharing Subsidy ............................... Other True Out-of Pocket Amount ................................ Patient Liability Reduction due to Other Payer Amount ....... VerDate Sep<11>2014 21:19 Apr 27, 2016 FY 2014 expenditures $41,722,567 95,389,484 1,704,601 We further analyzed Part D drug TABLE 4—DRUG COST SOURCES FOR HOSPICE BENEFICIARIES’ FY 2014 expenditures by the top twenty most DRUGS RECEIVED THROUGH PART frequently reported principal diagnoses on hospice claims for beneficiaries D—Continued FY 2014 expenditures Component Covered Drug Plan Paid Amount ................................ Non-Covered Plan Paid Amount ................................ Six Payment Amount Totals ... Unknown/Unreconciled ........... Gross Total Drug Costs, Reported .................................. 196,242,194 18,428,208 366,303,799 5,374,873 371,678,672 Source: Analysis of 100% FY 2014 Medicare Claim Files. For more information on the components above and on Part D data, go to the Research Data Assistance Center’s (ResDAC’s) Web site at: https:// www.resdac.org/. under a hospice election. These Part D expenditures included those for common palliative drugs, which include analgesics (anti-inflammatory, nonnarcotic, and opioids), antianxiety agents, antiemetics, and laxatives. The analysis also includes other drugs typically associated with the conditions reported. Table 5 details Part D spending for hospice beneficiaries by the top twenty most frequently reported principal diagnoses on hospice claims. Overlapping hospice claims are defined as claims for any Part D drugs that were dispensed on a day that the beneficiary also received hospice care. 12,816,746 Jkt 238001 PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 E:\FR\FM\28APP2.SGM 28APP2 EP28AP16.004</GPH> mstockstill on DSK3G9T082PROD with PROPOSALS2 Component 25509 25510 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules TABLE 5—SUMMARY OF OVERLAPPING PART D DRUGS BY TOP 20 MOST FREQUENTLY REPORTED HOSPICE PRINCIPAL DIAGNOSES IN FY 2014 Terminal condition 3D– DGN 331 ...... 162 ...... Lung Cancer ............. 294 ...... Mental Disorder (Chronic). COPD ....................... Mental Disorder (Senile & Presenile). Other Heart Diseases 436 ...... Stroke(Acute) ........... 332 ...... Parkinson’s disease 585 ...... mstockstill on DSK3G9T082PROD with PROPOSALS2 429 ...... Chronic Renal Failure. 438 ...... Number of overlapping hospice claims Number of Part D Rx Part D gross drug payment ($) .......................................................... Cerebral Degenerations. Heart Failure ............ 290 ...... Hospice beneficiaries (%) 167,677 12.6 .................... .................... .................... Common Palliative Drugs ................ Psychotherapeutic and Neurological Agents—Misc. Antipsychotics/Antimanic Agents .... .......................................................... Common Palliative Drugs ................ Cardiovascular Agents—Misc ......... Antihypertensives ............................ Antianginal Agents .......................... Diuretics ........................................... Beta Blockers .................................. Vasopressors ................................... .......................................................... Common Palliative Drugs ................ Antineoplastics and Adjunctive Therapies. .......................................................... .................... .................... .................... .................... 50,537 48,764 61,310 72,774 1,880,621 11,563,443 .................... 132,174 .................... .................... .................... .................... .................... .................... .................... 100,984 .................... .................... .................... 9.9 .................... .................... .................... .................... .................... .................... .................... 7.6 .................... .................... 35,307 .................... 38,110 509 24,889 11,118 38,081 29,545 775 .................... 20,689 2,042 46,857 .................... 46,448 602 29,843 13,085 50,186 32,833 857 .................... 25,723 2,217 3,229,221 .................... 1,589,113 1,243,362 783,221 688,201 485,243 480,877 71,657 .................... 1,182,222 2,093,837 81,364 6.1 .................... .................... .................... .................... .................... .................... .................... 26,355 21,181 32,457 31,800 971,792 4,868,784 .................... 79,267 .................... .................... .................... 6.0 .................... .................... 18,076 .................... 33,098 30,968 24,244 .................... 42,194 47,903 1,826,575 .................... 1,941,201 8,768,675 .................... .................... 70,852 .................... .................... 5.3 41 11,600 .................... 47 13,516 .................... 289,214 195,780 .................... Description 428 ...... 496 ...... Number of hospice beneficiaries Drug therapeutic classification Stroke(Late Effect) ... VerDate Sep<11>2014 21:19 Apr 27, 2016 Common Palliative Drugs ................ Psychotherapeutic and Neurological Agents—Misc. Antipsychotics/Antimanic Agents .... .......................................................... Common Palliative Drugs ................ Antiasthmatic and Bronchodilator Agents. Respiratory Agents—Misc ............... Corticosteroids ................................. .......................................................... Common Palliative Drugs ................ Psychotherapeutic and Neurological Agents—Misc. Antipsychotics/Antimanic Agents .... .......................................................... Common Palliative Drugs ................ Antihyperlipidemics .......................... Antihypertensives ............................ Cardiovascular Agents—Misc ......... Antianginal Agents .......................... Beta Blockers .................................. Diuretics ........................................... Calcium Channel Blockers .............. Vasopressors ................................... .......................................................... Common Palliative Drugs ................ Antihypertensives ............................ Antihyperlipidemics .......................... Anticoagulants ................................. Hematological Agents—Misc .......... Beta Blockers .................................. Calcium Channel Blockers .............. Cardiotonics ..................................... Diuretics ........................................... Cardiovascular Agents—Misc ......... Vasopressors ................................... .......................................................... Common Palliative Drugs ................ Antiparkinson Agents ...................... Psychotherapeutic and Neurological Agents—Misc. Antipsychotics/Antimanic Agents .... .......................................................... .................... .................... .................... .................... 24,206 19,923 29,992 29,954 877,181 4,527,689 .................... 51,616 .................... .................... .................... .................... .................... .................... .................... .................... .................... 33,766 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... 30,906 .................... .................... .................... .................... 3.9 .................... .................... .................... .................... .................... .................... .................... .................... .................... 2.5 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... 2.3 .................... .................... .................... 16,323 .................... 16,072 14,071 11,363 152 4,821 11,955 12,378 5,880 374 .................... 7,349 7,397 6,776 1,948 3,602 7,044 4,698 1,198 4,149 22 90 .................... 10,305 15,969 10,059 21,700 .................... 19,902 16,122 13,585 167 5,778 13,190 15,606 6,462 420 .................... 8,871 9,257 8,019 3,318 4,006 7,988 5,467 1,336 5,119 24 94 .................... 12,639 22,317 14,280 1,555,710 .................... 735,511 657,115 394,125 379,608 378,205 203,521 152,209 115,265 29,475 .................... 270,278 245,294 239,749 236,426 216,792 103,034 72,363 36,175 34,962 24,149 7,624 .................... 388,887 2,470,058 2,331,283 .................... 27,945 .................... 2.1 6,581 .................... 8,859 .................... 809,845 .................... Common Palliative Drugs ................ Hematological Agents—Misc .......... Diuretics ........................................... Nutrients .......................................... Minerals & Electrolytes .................... Vitamins ........................................... .......................................................... Common Palliative Drugs ................ Antihypertensives ............................ Anticoagulants ................................. Antihyperlipidemics .......................... .................... .................... .................... .................... .................... .................... 27,443 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... 2.1 .................... .................... .................... .................... 4,888 1,204 3,292 92 775 22 .................... 7,178 6,813 1,827 5,310 6,026 1,350 4,266 138 921 22 .................... 8,974 8,557 3,281 6,159 191,297 57,443 44,415 21,096 17,458 123 .................... 275,151 233,267 200,116 195,822 Jkt 238001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 E:\FR\FM\28APP2.SGM 28APP2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules 25511 TABLE 5—SUMMARY OF OVERLAPPING PART D DRUGS BY TOP 20 MOST FREQUENTLY REPORTED HOSPICE PRINCIPAL DIAGNOSES IN FY 2014—Continued Terminal condition Number of hospice beneficiaries Hospice beneficiaries (%) Number of overlapping hospice claims Number of Part D Rx Part D gross drug payment ($) Hematological Agents—Misc .......... Beta Blockers .................................. Calcium Channel Blockers .............. Diuretics ........................................... Cardiovascular Agents—Misc ......... .......................................................... Common Palliative Drugs ................ Digestive Aids .................................. Antineoplastics and Adjunctive Therapies. .......................................................... Common Palliative Drugs ................ Antiasthmatic and Bronchodilator Agents. Corticosteroids ................................. .......................................................... .................... .................... .................... .................... .................... 26,858 .................... .................... .................... .................... .................... .................... .................... .................... 2.0 .................... .................... .................... 2,989 7,192 4,635 3,826 22 .................... 4,809 554 367 3,311 8,170 5,427 4,991 29 .................... 5,854 610 403 184,818 109,777 75,992 36,531 23,212 .................... 302,932 269,356 146,428 26,683 .................... .................... 2.0 .................... .................... .................... 3,045 1,704 .................... 3,719 2,515 .................... 129,314 396,030 .................... 26,673 .................... 2.0 754 .................... 854 .................... 11,081 .................... Common Palliative Drugs ................ Antihyperlipidemics .......................... Antianginal Agents .......................... Antihypertensives ............................ Beta Blockers .................................. Cardiovascular Agents—Misc ......... Calcium Channel Blockers .............. Cardiotonics ..................................... .......................................................... Common Palliative Drugs ................ Antineoplastics and Adjunctive Therapies. .......................................................... Common Palliative Drugs ................ Antineoplastics and Adjunctive Therapies. .......................................................... Common Palliative Drugs ................ Antineoplastics and Adjunctive Therapies. .......................................................... Common Palliative Drugs ................ .......................................................... .................... .................... .................... .................... .................... .................... .................... .................... 26,668 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... 2.0 .................... .................... 8,831 7,927 3,741 6,448 6,817 32 3,163 1,164 .................... 5,906 523 10,882 8,987 4,577 7,674 7,506 37 3,492 1,272 .................... 7,458 574 425,098 367,409 276,861 222,786 117,183 61,455 54,946 33,187 .................... 322,177 387,221 25,174 .................... .................... 1.9 .................... .................... .................... 7,080 2,529 .................... 9,151 2,855 .................... 384,738 680,720 22,334 .................... .................... 1.7 .................... .................... .................... 4,446 1,500 .................... 5,655 1,668 .................... 293,249 2,363,693 18,846 .................... 17,859 1.4 .................... 1.3 .................... 6,469 .................... .................... 8,157 .................... .................... 364,686 .................... Common Palliative Drugs ................ .......................................................... Common Palliative Drugs ................ Antineoplastics and Adjunctive Therapies. .................... 15,242 .................... .................... .................... 1.1 .................... .................... 3,991 .................... 3,317 300 4,907 .................... 4,174 326 164,769 .................... 166,550 1,106,663 Drug therapeutic classification 3D– DGN Description 157 ...... Pancreatic Cancer .... 518 ...... Lung Diseases ......... 414 ...... Ischemic Heart Disease. 153 ...... Colon Cancer ........... 174 ...... Breast Cancer .......... 185 ...... Prostate Cancer ....... 491 ...... Chronic bronchitis .... 437 ...... Other Cerebrovascular Disease. 155 ...... Liver Cancer ............. mstockstill on DSK3G9T082PROD with PROPOSALS2 Source: CWF Claims Data, Prescription Drug TAP, Medicare Enrollment Database. Claims data through 12/18/2015. Included all beneficiaries with a paid hospice claim (excluding hospice claims for pre-election counselling and evaluation services) for which Part D drugs were filled on a day that the beneficiary also received hospice care. Hospices are required to cover drugs for the palliation and management of the terminal prognosis; we remain concerned that common palliative and other disease-specific drugs for hospice beneficiaries are being covered and paid for through Part D. Because hospices are required to provide a comprehensive range of services, including drugs, to Medicare beneficiaries under a hospice election, we believe that Medicare could be paying twice for drugs that are already covered under the hospice per diem payment by also paying for them under Part D.8 8 oig.hhs.gov/oas/region6/61000059.pdf ‘‘Medicare Could Be Paying Twice for Prescriptions For Beneficiaries in Hospice.’’ VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 Total non-hospice spending paid by either Medicare or by beneficiaries that occurred during a hospice election was $723.3 million ($600.8 million Medicare spending plus $122.5 million in beneficiary cost-sharing liabilities) for Parts A and B plus $371.6 million ($291.6 million Medicare spending plus $80 million in beneficiary cost-sharing liabilities) for Part D spending, or approximately $1.1 billion dollars total in FY 2014. c. Live Discharge Rates Currently, federal regulations allow a beneficiary who has elected to receive Medicare hospice services to revoke their hospice election at any time and for any reason. Specifically, the PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 regulations state that if the hospice beneficiary (or his/her representative) revokes the hospice election, Medicare coverage of hospice care for the remainder of that period is forfeited. The beneficiary may, at any time, reelect to receive hospice coverage for any other hospice election period that he or she is eligible to receive (§ 418.24(e) and § 418.28(c)(3)). During the time period between revocation/discharge and the re-election of the hospice benefit, Medicare coverage would resume for those Medicare benefits previously waived. A revocation can only be made by the beneficiary, in writing, that he or she is revoking the hospice election and the effective date of the revocation. A hospice cannot ‘‘revoke’’ a beneficiary’s E:\FR\FM\28APP2.SGM 28APP2 25512 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules qualifying for hospice services). Based upon the additional discharge information, Abt Associates, our research contractor performed analysis on FY 2014 claims to identify those beneficiaries who were discharged alive. In order to better understand the characteristics of hospices with high live discharge rates, we examined the aggregate cap status, skilled visit intensity; average lengths of stay; and non-hospice spending rates per beneficiary. While Figure 3 demonstrates an incremental decrease in average annual rates of live discharge rates from 2006 to 2014, peaking in 2007, there has been a leveling off at around 18 percent over the past several years. even if the care may be costly or inconvenient for the hospice program. As we indicated in the FY 2015 Hospice Wage Index and Payment Rate Update proposed and final rules, we understand that the rate of live discharges should not be zero, given the uncertainties of prognostication and the ability of beneficiaries and their families to revoke the hospice election at any time. On July 1, 2012, we began collecting discharge information on the claim to capture the reason for all types of discharges which includes, death, revocation, transfer to another hospice, moving out of the hospice’s service area, discharge for cause, or due to the beneficiary no longer being considered terminally ill (that is, no longer Among hospices with 50 or more discharges (discharged alive or deceased), there is significant variation in the rate of live discharge between the 10th and 90th percentiles (see Table 6). Most notably, hospices at the 95th percentile discharged 50 percent or more of their patients alive in FY 2014. average, 4.73 visits per week. We also found in FY 2014 that, when focusing on visits classified as skilled nursing or medical social services, hospices with live discharge rates at or above the 90th Live discharge percentile provided, on average, 1.88 Statistic visits per week versus hospices with rate (%) live discharge rates below the 90th 90th Percentile ...................... 39.1 percentile that provided, on average, 95th Percentile ...................... 50.0 2.34 visits per week. Note: n = 3,135 .................... ........................ We examined whether there was a Source: FY 2014 claims from SSS Analytic relationship between hospices with high File. live discharge rates, average lengths of stay, and non-hospice spending per In FY 2014, we found that hospices beneficiary per day (see Table 7 and with high live discharge rates also, on average, provided fewer visits per week. Figure 2). Hospices with patients that, Those hospices with live discharge rates on average, accounted for $27 per day at or above the 90th percentile provided, in non-hospice spending while in on average, 4.05 visits per week. hospice (decile 10 in Table 7 and Figure Hospices with live discharge rates 4) had live discharge rates that were, on below the 90th percentile provided, on average, about 34.7 percent and had an TABLE 6—DISTRIBUTION OF LIVE DISCHARGE RATES IN FY 2014 FOR HOSPICES WITH 50 OR MORE LIVE DISCHARGES Statistic Live discharge rate (%) 5th Percentile ........................ 10th Percentile ...................... 25th Percentile ...................... Median .................................. 75th Percentile ...................... VerDate Sep<11>2014 21:19 Apr 27, 2016 7.4 8.9 12.3 17.5 26.2 Jkt 238001 TABLE 6—DISTRIBUTION OF LIVE DISCHARGE RATES IN FY 2014 FOR HOSPICES WITH 50 OR MORE LIVE DISCHARGES—Continued PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 E:\FR\FM\28APP2.SGM 28APP2 EP28AP16.005</GPH> mstockstill on DSK3G9T082PROD with PROPOSALS2 hospice election, nor is it appropriate for hospices to encourage, request or demand that the beneficiary revoke his or her hospice election. Like the hospice election, a hospice revocation is to be an informed choice based on the beneficiary’s goals, values and preferences for the services they wish to receive through Medicare. Federal regulations limit the circumstances in which a Medicare hospice provider may discharge a patient from its care. In accordance with § 418.26, discharge from hospice care is permissible when the patient moves out of the provider’s service area, is determined to be no longer terminally ill, or for cause. Hospices may not discharge the patient at their discretion, Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules average lifetime length of stay of 158 days. In contrast, hospices with patients that, on average, accounted for only $3.66 per day in non-hospice spending while in a hospice election (decile 1 in Table 7 and Figure 4) had live discharge rates that were, on average, about 18.2 percent and had an average lifetime length of stay of 99.8 days. In other words, hospices in the highest decile, according to their level of non-hospice spending for patients in a hospice 25513 election, had live discharge rates and average lifetime lengths of stay that averaged 90 percent and 58 percent higher, respectively, than the hospices in lowest decile. TABLE 7—MEAN DAILY NON-HOSPICE MEDICARE UTILIZATION AND SUM TOTAL NON-HOSPICE UTILIZATION BY HOSPICE PROVIDER DECILE BASED ON SORTED NON-HOSPICE MEDICARE UTILIZATION PER HOSPICE DAY, FY 2014 Non-hospice Medicare ($) per hospice service day Decile 1 ....................................................................................................................................................................... 2 ....................................................................................................................................................................... 3 ....................................................................................................................................................................... 4 ....................................................................................................................................................................... 5 ....................................................................................................................................................................... 6 ....................................................................................................................................................................... 7 ....................................................................................................................................................................... 8 ....................................................................................................................................................................... 9 ....................................................................................................................................................................... 10 ..................................................................................................................................................................... All Hospices ..................................................................................................................................................... $3.66 5.50 6.88 8.11 9.26 10.63 12.12 14.03 16.84 26.60 11.37 Total non-hospice Medicare ($) $21,981,020 39,167,526 52,038,093 67,119,545 79,829,044 99,430,439 143,575,036 163,323,857 162,402,299 233,419,872 1,062,286,730 mstockstill on DSK3G9T082PROD with PROPOSALS2 Note: Analysis of 100 percent Medicare Analytic Files, FY 2014. Cohort is hospices with 50+ total discharges in FY 2014 [n = 3,135]. Hospice deciles are based on estimates of total non-hospice Medicare utilization ($) per hospice service day, excluding utilization on hospice admission or live discharge days. VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 E:\FR\FM\28APP2.SGM 28APP2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules The analytic findings in Table 7 and Figure 4 suggest that some hospices may be using the Medicare Hospice program inappropriately as a long-term care (‘‘custodial’’) benefit rather than an end of life benefit for terminal beneficiaries. As previously discussed in reports by MedPAC, there is a concern that hospices may be admitting beneficiaries who do not legitimately meet hospice eligibility criteria. Additionally, the Office of the Inspector General (OIG), has raised concerns about the potential for hospices to target beneficiaries who have long lengths of stay or certain diagnoses because they may offer the hospices the greatest financial gain.9 We 9 Medicare Hospices Have Financial Incentives To Provide Care in Assisted Living Facilities OEI–02– 14–00070. VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 continue to communicate and collaborate across CMS to improve monitoring and oversight activities of hospice activities. We expect to analyze more recent hospice claims and cost report data as they become available to determine whether additional regulatory proposals to reform and strengthen the Medicare hospice benefit are warranted. d. Skilled Visits in the Last Days of Life As we noted in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47164), we are concerned that many beneficiaries are not receiving skilled visits during the last few days of life. At the end of life, patient needs typically surge and more intensive services are warranted. However, analysis of FY 2014 claims data shows that on any given day during PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 the last 7 days of a hospice election, nearly 47 percent of the time the patient has not received a skilled visit (skilled nursing or social worker visit) (see Table 8). Moreover, on the day of death nearly 26 percent of beneficiaries did not receive a skilled visit (skilled nursing or social work visit). While Table 8 shows the frequency and length of skilled nursing and social work visits combined during the last 7 days of a hospice election in FY 2014, Tables 9 and 10 show the frequency and length of visits for skilled nursing and social work separately. Analysis of FY 2014 claims data shows that on any given day during the last 7 days of a hospice election, almost 49 percent of the time the patient had not received a visit by a skilled nurse, and 91 percent of the time the patient had not received a visit by a E:\FR\FM\28APP2.SGM 28APP2 EP28AP16.006</GPH> mstockstill on DSK3G9T082PROD with PROPOSALS2 25514 25515 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules social worker (see Tables 9 and 10, respectively). We believe it is important to assure that beneficiaries and their families and caregivers are, in fact, receiving the level of care necessary during critical periods such as the very end of life. TABLE 8—FREQUENCY AND LENGTH OF SKILLED NURSING AND SOCIAL WORK VISITS (COMBINED) DURING THE LAST SEVEN DAYS OF A HOSPICE ELECTION, FY 2014 Visit length One day before death (%) Day of death Two days before death (%) Three days before death (%) Four days before death (%) Five days before death (%) Six days before death (%) Last seven days combined (%) No visit ............................. 15 mins to 1 hr ................. 1 hr 15 m to 2 hrs ............ 2 hrs 15 m to 3 hrs .......... 3 hrs 15 m to 3 hrs 45m .. 4 or more hrs ................... 25.8 24.6 24.9 12.7 4.4 7.6 39.0 28.5 19.1 7.0 2.3 4.2 45.7 26.6 17.1 5.7 1.8 3.0 50.2 25.4 15.6 4.9 1.6 2.4 53.5 24.3 14.4 4.4 1.3 2.1 56.2 23.5 13.4 4.1 1.2 1.8 58.5 22.7 12.6 3.5 1.1 1.6 46.3 25.1 16.9 6.3 2.0 3.4 Total .......................... 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 Source: FY 2014 hospice claims data from the Standard Analytic Files for CY 2013 (as of June 30, 2014) and CY 2014 (as of December 31, 2015). TABLE 9—FREQUENCY AND LENGTH OF SKILLED NURSING VISITS DURING THE LAST SEVEN DAYS OF A HOSPICE ELECTION, FY 2014 Visit length One day before death (%) Day of death Two days before death (%) Three days before death (%) Four days before death (%) Five days before death (%) Six days before death (%) Last seven days combined (%) No visit ............................. 15 mins to 1 hr ................. 1 hr 15 m to 2 hrs ............ 2 hrs 15 m to 3 hrs .......... 3 hrs 15 m to 3 hrs 45m .. 4 or more hrs ................... 27.2 25.1 25.2 12.3 4.0 6.3 41.6 29.5 18.6 5.5 1.7 3.2 48.6 27.1 16.5 4.4 1.3 2.2 53.1 25.5 14.8 3.7 1.0 1.8 56.5 24.3 13.6 3.3 0.8 1.5 59.2 23.3 12.6 2.9 0.8 1.3 61.5 22.3 11.8 2.6 0.8 1.2 48.9 25.5 16.4 5.2 1.6 2.6 Total .......................... 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 Source: FY 2014 hospice claims data from the Standard Analytic Files for CY 2013 (as of June 30, 2014) and CY 2014 (as of December 31, 2015). TABLE 10—FREQUENCY AND LENGTH OF SOCIAL WORK VISITS DURING THE LAST SEVEN DAYS OF A HOSPICE ELECTION, FY 2014 Visit length One day before death (%) Day of death Two days before death (%) Three days before death (%) Four days before death (%) Five days before death (%) Six days before death (%) Last seven days combined (%) No visit ............................. 15 mins to 1 hr ................. 1 hr 15 m to 2 hrs ............ 2 hrs 15 m to 3 hrs .......... 3 hrs 15 m to 3 hrs 45m .. 4 or more hrs ................... 91.6 4.9 2.5 0.6 0.2 0.2 89.1 7.1 3.1 0.6 0.0 0.1 90.2 6.4 2.8 0.4 0.0 0.1 90.9 6.1 2.6 0.3 0.0 0.0 91.5 5.7 2.4 0.2 0.0 0.0 91.9 5.5 2.2 0.2 0.0 0.0 92.3 5.2 2.1 0.2 0.0 0.0 91.0 5.8 2.6 0.4 0.0 0.1 Total .......................... 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 mstockstill on DSK3G9T082PROD with PROPOSALS2 Source: FY 2014 hospice claims data from the Standard Analytic Files for CY 2013 (as of June 30, 2014) and CY 2014 (as of December 31, 2015). A recent article published in the Journal of American Medicine (JAMA) titled ‘‘Examining Variation in Hospice Visits by Professional Staff in the Last 2 Days of Life’’ also highlighted concerns regarding the lack of visits by professional hospice staff (defined as nursing staff (RN and LPN), social workers, nurse practitioners, or physicians) in the last days of a hospice VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 episode. This study found that, of the 661,557 Medicare hospice beneficiaries who died in FY 2014, 81,478 (12.3 percent) received no professional staff visits in the last 2 days of life. Furthermore, professional staff from 281 hospice programs, with at least 30 discharges during federal fiscal year 2014, did not visit any of their patients who were entitled to have received such PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 RHC services during the last 2 days of life. Additionally, the investigation demonstrated that black patients and frail, older adults residing in nursing homes and enrolled in Medicare hospice often did not receive visits from hospice staff in the last 2 days of life, raising concerns over disparities of care. The authors believe that further research is needed in order to understand E:\FR\FM\28APP2.SGM 28APP2 25516 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules mstockstill on DSK3G9T082PROD with PROPOSALS2 whether a lack of visits by professional staff affects the quality of care for the dying person and their family.10 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 a myriad of physical and emotional symptoms, necessitating close care and attention from the integrated hospice team. 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. This is discussed further in section III.C.6, Proposed Updates to the Hospice Quality Reporting Program, where a new hospice quality reporting measure is proposed, ‘‘Hospice Visits when Death is Imminent’’. We believe that the implementation of the Service Intensity Add-on (SIA) payment, finalized in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47164 through 47177), represents an incremental step toward encouraging higher frequency of much-needed end of life care by encouraging visits during beneficiaries’ most intensive time of need for skilled care—the last 7 days of life. 2. Monitoring for Impacts of Hospice Payment Reform As noted above, in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47142), we finalized the creation of two RHC rates—one RHC rate for the first 60 days of hospice care and a second RHC rate for days 61 and beyond. As noted in section III.A.1.d, in the same final rule, we also created a SIA payment. The SIA payment is paid in addition to the RHC per diem payment for direct care provided by a RN or social worker in the last 7 days of life. The two RHC rates and the SIA payment became effective on January 1, 2016. The goal of these hospice payment reform changes is to more accurately align hospice payment with resource utilization while encouraging appropriate, high-quality hospice care, and maximizing beneficiary, family, and caregiver satisfaction with care. As noted in the FY 2016 final rule, as data become available, we will monitor the impact of 10 Teno, J., Plotzke, M., Christian, T. & Gozalo, P. (2016). Examining Variation in Hospice Visits by Professional Staff in the Last 2 Days of Life. Journal of American Medicine Internal Medicine. Published online February 8, 2016. doi:10.1001/ jamainternmed.2015.7479. VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 the hospice payment reform changes finalized in the rule as well as continue to monitor general hospice trends to help inform future policy efforts and program integrity measures. This monitoring and analysis will include, but not be limited to, monitoring hospice diagnosis reporting, lengths of stay, live discharge patterns and their relationship with the provision of services and the aggregate cap, nonhospice spending for Parts A, B and D during a hospice election, trends of live discharge at or around day 61 of hospice care, and readmissions after a 60 day lapse since live discharge. Specifically, we will work with our monitoring contractor, Acumen LLC, to conduct comprehensive, real time monitoring and analysis of hospice claims to help identify program vulnerabilities, as well as potential areas of fraud and abuse. To monitor overall usage and payment trends in hospice, Acumen will track monthly and annual changes in the following metrics. 1. Percentage of Medicare beneficiaries electing hospice 2. Total number of Medicare hospice patients 3. Demographic and geographic location characteristics among Medicare hospice patients 4. Number and share of Medicare hospice patients presenting with various terminal conditions, aggregated by broader clinical categories 5. Total payment for hospice care (also by level of care) 6. Number and share of live discharges 7. Number and rate of readmissions 8. Average length of episodes 9. Proportion of days by level of care (RHC, CHC, general inpatient care (GIP), and inpatient respite care (IRC)) 10. Volume and payments for nonhospice services used during hospice stays Additionally, to address policy impacts, specifically for the hospice payment reform provisions finalized in the FY 2016 Hospice Wage Index and Payment Rate Update final rule, Acumen will longitudinally monitor the effect of changes in the RHC payment rate on volume and payments for hospice care using the following metrics: 1. Average length of hospice stays 2. Total number and share of live discharges 3. Average readmissions rates within or after 60 days Acumen will monitor the effects of the new SIA payment policy using the following metrics: PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 1. Total number of nursing visits (also separately for RNs and LPNs) 2. Total number of visits by social workers 3. Average number of services billed per discharge 4. Average number of hours billed per discharge and per hospice day 5. Average number of services billed during the first 7 days, middle of a stay, and last 7 days of a hospice stay 6. Intensity of services billed during the first 7 days, middle of a stay, and last 7 days of a hospice stay These measures are further broken down by level of care (for example, RHC versus CHC) to understand the effect of the SIA payment policy on incentivizing care at the RHC level. The monitoring analysis can be examined at the aggregate level as well as at the individual provider level. This comprehensive and provider-level monitoring will not only inform future policymaking decisions but targeted program integrity efforts as well. In addition to Acumen LLC’s comprehensive, real time monitoring and analysis of hospice claims, we have developed a hospice Program for Evaluating Payment Patterns Electronic Reports (PEPPER), which generates informational tables provided to hospices that summarize providerspecific Medicare data statistics for target areas often associated with Medicare improper payments due to billing, coding and/or admission necessity issues. The intent of the hospice PEPPER is to help inform hospices of potential program administration and other vulnerabilities to provide the opportunity for improvement. Specifically, these reports can be used to compare performance of a specific hospice to that of other hospices in various geographic delineations, including the nation, specific MAC jurisdictions, and states. PEPPER can also be used to compare data statistics over time to identify changes in billing practices, to pinpoint areas in need of auditing and monitoring, identify other potential problems and to help hospices achieve CMS’ goal of reducing and preventing improper payments. The hospice PEPPER provides various metrics, including several markers of live discharges on various time intervals, markedly long lengths of stay, as well as information regarding levels and frequency of hospice care provided in various settings. Recently added metrics include differentiating reasons for live discharges (for example, beneficiary being no longer terminally ill, patient E:\FR\FM\28APP2.SGM 28APP2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules revocations), live discharges with length of stay between 61 to179 days, claims with a single diagnosis coded, and hospice episodes of care when no GIP or CHC is provided. B. Proposed FY 2017 Hospice Wage Index and Rate Update mstockstill on DSK3G9T082PROD with PROPOSALS2 1. Proposed 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 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 hospital pre-floor, prereclassified 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 https://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, 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 VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 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, prereclassified 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 prefloor, 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, prereclassified 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 proposed rule, for FY 2017, we propose to continue to use the most recent prefloor, 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 prereclassified 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. PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 25517 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 Combines Statistical Areas, and guidance on uses of the delineation in these areas. A copy of this bulletin is available online at: https://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 37246–37252) 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 1year 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. The proposed wage index applicable for FY 2017 is available on the CMS Web site at https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/Hospice/. The proposed wage index applicable for FY 2017 will not be published in the Federal Register. The proposed hospice wage index for FY 2017 would be effective October 1, 2016 through September 30, 2017. 2. Proposed 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 E:\FR\FM\28APP2.SGM 28APP2 mstockstill on DSK3G9T082PROD with PROPOSALS2 25518 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules 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 10year 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: https://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 proposed hospice payment update percentage for FY 2017 is based on the estimated inpatient hospital market basket update of 2.8 percent (based on IHS Global Insight, Inc.’s first quarter 2016 forecast with historical data through the fourth quarter of 2015). Due to the requirements at 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 2.8 percent must be reduced by a MFP adjustment as mandated by Affordable Care Act (currently estimated to be 0.5 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 proposed hospice payment update percentage for FY 2017 is 2.0 percent. We are also proposing that if more recent data are subsequently available (for example, a more recent estimate of the inpatient hospital market basket update and MFP adjustment), we would use such data, if appropriate, to determine the FY 2017 market basket VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 update and the MFP adjustment in the FY 2017 Hospice Rate Update final rule. 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. 3. Proposed 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 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, if certain criteria are met. In order to maintain budget neutrality, as required under section 1814(i)(6)(D)(ii) of the Act, the new RHC rates were adjusted by a SIA budget neutrality factor. As discussed in the FY 2016 Hospice Wage Index and Payment Rate Update PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 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 would apply to days 1 through 60 is calculated to be 1.0001. The budget neutrality adjustment that would apply to days 61 and beyond is calculated to be 0.9999. For FY 2017, we are proposing to apply 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 would eliminate the aggregate effect of annual variations in hospital wage data. We believe that adopting a hospice wage index standardization factor would provide a safeguard to the Medicare program as well as to hospices because it would 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 would be increased by the full proposed FY 2017 hospice payment update percentage of 2.0 percent as discussed in section III.C.3. The proposed FY 2017 RHC rates are shown in Table 11. The proposed FY 2017 payment rates for CHC, IRC, and GIP are shown in Table 12. E:\FR\FM\28APP2.SGM 28APP2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules 25519 TABLE 11—PROPOSED FY 2017 HOSPICE RHC PAYMENT RATES FY 2016 payment rates Code Description 651 .................... 651 .................... Routine Home Care (days 1–60) ..... Routine Home Care (days 61+) ....... $186.84 146.83 SBNF Proposed wage index standardization factor × 1.0001 × 0.9999 × 0.9990 × 0.9995 FY 2017 proposed hospice payment update percentage × 1.020 × 1.020 FY 2017 proposed payment rates $190.41 149.68 TABLE 12—PROPOSED FY 2017 HOSPICE CHC, IRC, AND GIP PAYMENT RATES FY 2016 payment rates Code Description 652 .................... Continuous Home Care ................................................ Full Rate = 24 hours of care 40.16 = FY 2017 hourly rate Inpatient Respite Care .................................................. General Inpatient Care ................................................. 655 .................... 656 .................... 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 Proposed wage index standardization factor FY 2017 proposed hospice payment update percentage FY 2017 proposed payment rates $944.79 × 1.0000 × 1.020 $963.69 167.45 720.11 × 1.0000 × 0.9996 × 1.020 × 1.020 170.80 734.22 Affordable Care Act. Hospices were required to begin collecting quality data in October 2012, and submit that quality data in 2013. Section 1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014 and each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements with respect to that FY. The proposed FY 2017 rates for hospices that do not submit the required quality data would be updated by the proposed FY 2017 hospice payment update percentage of 2.0 percent minus 2 percentage points. These rates are shown in Tables 13 and 14. TABLE 13—PROPOSED FY 2017 HOSPICE RHC PAYMENT RATES FOR HOSPICES THAT DO NOT SUBMIT THE REQUIRED QUALITY DATA FY 2016 payment rates Code Description 651 .................... 651 .................... Routine Home Care (days 1–60) ..... Routine Home Care (days 61+) ....... $186.84 146.83 SBNF × 1.0001 × 0.9999 Proposed wage index standardization factor × 0.9990 × 0.9995 FY 2017 proposed hospice payment update of 2.0% minus 2 percentage points = 0.0% × 1.000 × 1.000 FY 2017 proposed payment rates $186.67 146.74 TABLE 14—PROPOSED FY 2017 HOSPICE CHC, IRC, AND GIP PAYMENT RATES FOR HOSPICES THAT DO NOT SUBMIT THE REQUIRED QUALITY DATA FY 2016 payment rates mstockstill on DSK3G9T082PROD with PROPOSALS2 Code Description 652 .................... Continuous Home Care ................................................ Full Rate = 24 hours of care $39.37 = FY 2017 hourly rate Inpatient Respite Care .................................................. General Inpatient Care ................................................. 655 .................... 656 .................... VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00023 Fmt 4701 Proposed wage index standardization factor FY 2017 proposed hospice payment update of 2.0% minus 2 percentage points = 0.0% FY 2017 proposed payment rates $944.79 × 1.000 $944.79 167.45 720.11 Sfmt 4702 × 1.0000 × 1.0000 × 0.9996 × 1.000 × 1.000 167.45 719.82 E:\FR\FM\28APP2.SGM 28APP2 25520 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules 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 fiscal year 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 $28,377.17, which is equal to the 2016 cap amount ($27,820.75) updated by the FY 2017 hospice payment update percentage of 2.0 percent. mstockstill on DSK3G9T082PROD with PROPOSALS2 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 0.0 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 VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 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 consensusbased organization identified by the Secretary. Our paramount concern is the successful development of a HQRP that promotes the delivery of high quality healthcare services. We seek to adopt measures for the HQRP that promote 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: https://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 (https:// www.qualityforum.org/npp/), the HHS Strategic Plan (https://www.hhs.gov/ secretary/about/priorities/ priorities.html), the National Strategy for Quality Improvement in Healthcare, (https://www.ahrq.gov/workingfor PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 quality/nqs/nqs2013annlrpt.htm) and the CMS Quality Strategy (https://www. cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/Quality InitiativesGenInfo/CMS-QualityStrategy.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/payers, and other stakeholders. 3. Policy for Retention of HQRP Measures Adopted for Previous Payment Determinations In the FY 2016 Hospice Wage Index final rule, for the purpose of streamlining the rulemaking process, we stated 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 if: • 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 was 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 E:\FR\FM\28APP2.SGM 28APP2 mstockstill on DSK3G9T082PROD with PROPOSALS2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules 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 propose to codify that if measures we are using in the HQRP undergo non-substantive changes in the specifications as part of their NQF reendorsement process, we would subsequently utilize the measure with their new endorsed status in the HQRP without going through new notice-andcomment rulemaking. 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 (https:// www.qualityforum.org/About_NQF/ Mission_and_Vision.aspx). The NQF undertakes review of: (1) New quality measures and national consensus standards for measuring and publicly reporting on performance; (2) regular maintenance processes for endorsed quality measures; (3) measures with time limited endorsement for consideration of full endorsement; and (4) 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, or 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,11 we believe that the NQF measure endorsement and maintenance process itself is transparent, scientifically rigorous, and provides opportunity for public input. Thus, we propose to codify at § 418.312 that if the NQF makes only nonsubstantive changes to specifications for HQRP measures in the NQF’s reendorsement 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 (that is, with CMS modifications). An application of a NQF-endorsed quality measure is utilized in instances when we have identified a need to use a NQFendorsed measure in a QRP, but needs to use it with one or more modifications to the quality measure’s specifications. We may modify one or more of the following aspects of a NQF-endorsed quality measure: (1) Numerator; (2) denominator; (3) setting; (4) look-back period; (5) calculation period; (6) risk adjustment; and (7) revisions to data elements used to collect the data the data required for the measure. Reasons for not adopting changes in measure specifications may include any of the aforementioned criteria for removal, 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 vs non-substantive change on a measure-by-measure basis. 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. 11 ‘‘NQF: How Endorsement Happens—National Quality Forum.’’ 2010. 26 Jan. 2016 https:// www.qualityforum.org/Measuring_Performance/ ABCs/How_Endorsement_Happens.aspx. VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 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), We 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, PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 25521 collection of the needed data elements would require a standardized data collection instrument. In response, we developed, tested, and implemented a hospice patient-level item set, the HIS. Hospices are required to submit a HISAdmission 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 HISDischarge 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 E:\FR\FM\28APP2.SGM 28APP2 25522 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules 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 No. Treatment Preferences ............................ 1641 Beliefs/Values Addressed ........................ Pain Screening ........................................ Pain Assessment ..................................... Dyspnea Screening ................................. Dyspnea Treatment ................................. Patients Treated with an Opioid who are Given a Bowel Regimen. Submission method Data submission deadlines Process Measure ... Hospice Item Set .... Within 30 days of patient admission or discharge (Event Date). 1647 1634 1637 1639 1638 1617 5. Proposed Removal of Previously Adopted Measures As mentioned in section III.E.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.E.3 of this proposed rule. We are 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 mstockstill on DSK3G9T082PROD with PROPOSALS2 Type a. Background and Considerations in Developing New Quality Measures for the HQRP As noted in section III.E.2 of this proposed rule, our 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, we take 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, we 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 VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 September 2014.12 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. As stated in the FY 2016 Hospice Wage Index final rule (80 FR 47188), based on input from stakeholders, we 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, we have pursued measure development for 2 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 on 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 PostAcute Care/Long-Term Care Workgroup Web page at: https://www.qualityforum. org/ProjectMaterials.aspx?project ID=75370. The MAP supported the direction of each proposed measure. 12 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. PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 b. New Quality Measures for the FY 2019 Payment Determination and Subsequent Years We are proposing 2 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 as follows: 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 and addresses case management and clinical care. 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 and 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 E:\FR\FM\28APP2.SGM 28APP2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules mstockstill on DSK3G9T082PROD with PROPOSALS2 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, and hospital death, and 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 13 and the NCP Clinical Practice Guidelines for Quality Palliative Care 14 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 15 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. Measure Impact. The literature shows that health care providers’ practice is responsive to quality measuring and reporting.16 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 13 National Quality Forum. A National Framework and Preferred Practices for Palliative and Hospice Care Quality. 2006; Available from: https://www.qualityforum.org/publications/2006/12/ A_National_Framework_and_Preferred_Practices_ for_Palliative_and_Hospice_Care_Quality.aspx. 14 National Consensus Project, Clinical Practice Guidelines for Quality Palliative Care. 3rd edition. 2013, National Consensus Project: Pittsburgh, PA. 15 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. 16 Werner, R., E. Stuart, and D. Polsky, Public reporting drove quality gains at nursing homes. Health Affairs, 2010. 29(9): p. 1706–1713. VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 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. 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.17 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). 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 14th and 15th, 2015 and provided input to CMS. The MAP encouraged continued development of the Hospice Visits when Death is Imminent measure pair in the HQRP. 17 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. PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 25523 More information about the MAP’s recommendations for this measure is available at: https:// 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. We have proposed that 4 new items be added to the HIS-Discharge record to collect the necessary data elements for this measure. We expect that data collection for this quality measure via the 4 new HIS items would begin no earlier than April 1, 2017. Thus, under our current 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, we 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.E.7c through III.E.7e of this proposed rule. In those sections, we 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. 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-PatientAssessment-Instruments/HospiceQuality-Reporting/CurrentMeasures.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-andGuidance/Legislation/Paperwork ReductionActof1995/PRA-Listing.html. E:\FR\FM\28APP2.SGM 28APP2 25524 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules mstockstill on DSK3G9T082PROD with PROPOSALS2 We invite public comment on our proposal to implement the Hospice Visits when Death is Imminent measure pair beginning April 1, 2017, as previously (2) Proposed Quality Measure 2: Hospice and Palliative Care Composite Process Measure—Comprehensive Assessment at Admission Measure Background. The Hospice and Palliative Care Composite Process Measure—Comprehensive Assessment at Admission is a composite measure that assesses whether a comprehensive patient assessment is completed at hospice admission by evaluating the number of individual care processes completed upon admission for each hospice patient stay. A composite measure, as defined by the NQF, is a combination of 2 or more component measures, each of which individually reflects quality of care, into a single performance measure with a single score.18 For more information on composite measure definitions, guiding principles, and measure evaluation criteria, we refer readers to the NQF Composite Performance Measure Evaluation Guidance Publication available at: https://www.qualityforum. org/Publications/2013/04/Composite_ Performance_Measure_Evaluation_ Guidance.aspx. A total of 7 individual care processes will be captured in this composite measure, which include the 6 NQF-endorsed quality measures and 1 modified NQF-endorsed quality measure currently implemented in the HQRP. Thus, the Hospice and Palliative Care Composite Process quality measure will use the current HQRP quality measures as its components. These individual component measures address care processes around hospice admission that are clinically recommended or required in the hospice CoPs.19 This measure calculates the percentage of patients who received all care processes at admission. To calculate this measure, the individual component of the composite measure are assessed separately for each patient and then aggregated into one score for each hospice. Measure Importance. This composite quality measure for comprehensive assessment at admission addresses high priority aspects of quality hospice care as identified by both leading hospice stakeholders and beneficiaries receiving 18 National Quality Forum. (2013). Composite Performance Measure Evaluation Guidance: National Quality Forum. 19 Medicare and Medicaid Programs: Hospice Conditions of Participation, Part 418 subpart 54. Centers for Medicare and Medicaid Services, June 5, 2008. VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 hospice services. The NCP for Quality Palliative Care Clinical Practice Guidelines for Quality Palliative Care established 8 core palliative care domains, and this composite measure captures 4 of those domains.20 The 4 domains captured by this composite measure are: The Structure and Process of Care Domain; the Physical Aspects of Care Domain; the Spiritual, Religious, and Existential Aspects of Care Domain, and the Ethical and Legal Aspects of Care Domain. The NCP guidelines placed equal weight on both the physical and psychosocial domains, emphasizing a comprehensive approach to patient care. For more information on the NCP domains for palliative care, refer to: https://www.nationalconsensus project.org/guidelines_download2.aspx. In addition, the Medicare Hospice CoPs require that hospice comprehensive assessments identify patients’ physical, psychosocial, emotional, and spiritual needs, and address them to promote the hospice patient’s comfort throughout the end-of-life process. Furthermore, the person-centered, family, and caregiver perspective align with the domains identified by the CoPs and NCP, as patients and their families/caregiver also place value on physical symptom management and spiritual/psychosocial care as important factors at the end of life.21 22 A composite measure serves to ensure all hospice patients receive a comprehensive assessment for both physical and psychosocial needs at admission. Measure Impact. The literature indicates that health care providers’ practice is responsive to quality measures reported.23 We believe this research, while not specific to hospices, reasonably predicts the effect of measures on hospice provider behavior. Collecting information about the total number of care processes conducted for each patient will incentivize hospices to conduct all desirable care processes for each patient and provide services that will address their care needs and improve quality during the time he/she is receiving hospice care. Additionally, creating a composite quality measure for 20 The National Consensus Project for Quality Palliative Care Clinical Practice Guidelines for Quality Palliative Care 3rd edition 2013. 21 Singer PA, Martin DK, Kelner M. Quality Endof-Life Care: Patients’ Perspectives. JAMA. 1999;281(2):163–168. doi:10.1001/jama.281.2.163. 22 Steinhauser KE, Christakis NA, Clipp EC, McNeilly M, McIntyre L, Tulsky JA. Factors Considered Important at the End of Life by Patients, Family, Physicians, and Other Care Providers. JAMA. 2000;284(19):2476–2482. doi:10.1001/ jama.284.19.2476. 23 Werner, R., E. Stuart, and D. Polsky, Public reporting drove quality gains at nursing homes. Health Affairs, 2010. 29(9): p. 1706–1713. PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 comprehensive assessment at admission will provide consumers and providers with a single measure regarding the overall quality and completeness of assessment of patient needs at hospice admission, which can then be used to meaningfully and easily compare quality across hospice providers and increase transparency. Performance Gap. Analyses conducted by our measure development contractor, RTI International, show that hospice performance scores on the current 7 HQRP measures are high (a score of 90 percent or higher) however, these analyses also revealed that, on average, only 68.1 percent of patient stays in a hospice had documentation that all of these desirable care processes were done at admission. Thus, by assessing hospices’ performance of comprehensive assessment, the composite measure sets a higher standard of care for hospices and reveals a larger performance gap. A similar effect has been shown in the literature where facilities are achieving more than 90 percent compliance with individual measures, but compliance numbers decrease when multiple measures are combined as one.24 25 The performance gap identified by the composite measure creates opportunities for quality improvement and may motivate providers to conduct a greater number of high priority care processes for as many patients as possible upon admission to hospice. Existing Measures. The Family Evaluation of Hospice Care (FEHC), NQF #0208, is a precursor of the Hospice CAHPS®. The surveys cover some similar domains. However, a major difference between them is the detailed requirements for survey administration of the CAHPS® Hospice Survey, which allow for comparison of hospice programs, The Hospice CAHPS® survey quality measure is not yet endorsed by NQF. We have recently submitted the CAHPS® Hospice Survey (experience of care) measure (NQF #2651) to be considered for endorsement under the Palliative and End-of-Life Care Project 2015–2016. For more information regarding this project and the measure submitted, we refer readers to https://www.qualityforum. org/ProjectMeasures.aspx?projectID= 80663. In addition, we refer readers to section III.E.9 of this proposed rule for more information on the Hospice CAHPS® survey and associated quality 24 Nolan, T., & Berwick, D. M. (2006). All-or-none measurement raises the bar on performance. JAMA [H.W. Wilson—GS], 295(10), 1168. 25 Agency for Healthcare Research and Quality. (2004). National Healthcare Quality Report. E:\FR\FM\28APP2.SGM 28APP2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules measures. The CAHPS®-based quality measures submitted to NQF include patient and caregiver experience of care outcome measures, and our plan to propose these measures as part of the HQRP measure set in future rulemaking cycles. A key difference between the FEHC, Hospice CAHPS® and the Hospice and Palliative Care Composite Process Measure is that the FEHC and Hospice CAHPS® focus on the consumer’s perspective of their health agency and experience, whereas the Hospice and Palliative Care Composite Process Measure focuses on the clinical care processes that are actually delivered by the hospice to each patient. Stakeholder Support. A TEP convened by our measure development contractor, RTI International, on December 2, 2015, provided input on this measure concept. The TEP unanimously agreed that a comprehensive hospice composite measure is an important measure and supported data collection using the HIS. The NQF MAP met on December 14th and 15th, 2015 and provided input to CMS. In their final recommendation, the MAP encouraged continued development of the Hospice and Palliative Care Composite Process Measure—Comprehensive Assessment at Admission measure. More information about the MAP’s recommendations for this measure is available at: https://www.qualityforum. org/ProjectMaterials.aspx?project ID=75370. While this measure is not currently NQF-endorsed, we recognize that the NQF endorsement process is an important part of measure development and plan to submit this measure for NQF endorsement. As noted, this quality measure will fill a gap by holding hospices to a higher standard of care and will motivate providers to conduct a greater number of high priority care processes for as many beneficiaries as possible upon admission as hospice patients. Furthermore, no current NQF-endorsed measures address the completion of a comprehensive care assessment at hospice admission. Form, Manner, and Timing of Data Collection and Submission. The data source for this measure will be currently implemented HIS items that are currently used in the calculation of the 7 component measures. These items and quality measure algorithms for the 7 component measures can be found in the HQRP Specifications for the Hospice Item Set-based Quality Measures document, which is available in the ‘‘Downloads’’ section of the ‘‘Current Measures’’ portion of the CMS HQRP Web site: https://www.cms.gov/ Medicare/Quality-Initiatives-PatientAssessment-Instruments/HospiceQuality-Reporting/CurrentMeasures.html. Since the proposed measure is a composite measure whose components are currently adopted HQRP measures, no new data collection will be required; data for the composite 25525 measure will come from existing items from the existing 7 HQRP component measures. We propose to begin calculating this measure using existing data items, beginning April 1, 2017; this means patient admissions occurring after April 1, 2017 would be included in the composite measure calculation. Since the composite measure components are existing HIS data items, providers are already collecting the data needed to calculate the composite measure. Data collection will continue in accordance with processes outlined in sections III.E.7c through III.E.7e of this proposed rule. For more information on the specifications and data elements for the measure, Hospice and Palliative Care Composite Process MeasureComprehensive Assessment at Admission, we refer readers to the https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Hospice-Quality-Reporting/ Current-Measures.html document, available on the ‘‘Current Measures’’ portion of the CMS HQRP Web site: https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Hospice-Quality-Reporting/ Current-Measures.html. We invite public comment on our proposal to implement the Hospice and Palliative Care Composite Process Measure—Comprehensive Assessment at Admission beginning April 1, 2017, as previously described for the HQRP. TABLE 16—PROPOSED QUALITY MEASURES AND DATA COLLECTION PERIOD AFFECTING THE FY 2019 PAYMENT DETERMINATION AND SUBSEQUENT YEARS Quality measure NQF ID No. Hospice Visits when Death is Imminent ..................... Hospice and Palliative Care Composite Process Measure. TBD TBD Type Submission method Process Measure ............. Hospice Item Set ............. a. Background b. Previously Finalized Policy for New Facilities To Begin Submitting Quality Data Section 1814(i)(5)(C) of the Act requires that each hospice submit data to the Secretary on quality measures specified by the Secretary. Such data must be submitted in a form and manner, and at a time specified by the Secretary. Section 1814(i)(5)(A)(i) of the Act requires that beginning with the FY 2014 and for each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements for that FY. In the FY 2015 Hospice Wage Index final rule (79 FR 50488), we finalized a policy stating that any hospice that receives its CMS Certification Number (CCN) (also known as the Medicare Provider Number) notification letter dated on or after November 1 of the preceding year involved is excluded from any payment penalty for quality reporting purposes for the following FY. This requirement was codified at § 418.312. In the FY 2016 Hospice Wage Index final rule (80 FR 47189), we further mstockstill on DSK3G9T082PROD with PROPOSALS2 7. Form, Manner, and Timing of Quality Data Submission VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 Data collection to begin 04/01/2017 clarified and finalized our policy for the timing of new providers to begin reporting data to CMS. The clarified policy finalized in the FY 2016 Hospice Wage Index final rule (80 FR 47189) distinguished between when new hospice providers are required to begin submitting HIS data and when providers will be subject to the potential 2 percentage point annual payment update (APU) reduction for failure to comply with HQRP requirements. In summary, the policy finalized in the FY 2016 Hospice Wage Index final rule (80 FR 47189 through 47190) clarified that providers must begin submitting HIS data on the date listed in the letterhead of the CCN Notification letter received E:\FR\FM\28APP2.SGM 28APP2 25526 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules mstockstill on DSK3G9T082PROD with PROPOSALS2 from us, but will be subject to the APU reduction based on whether the CCN Notification letter was dated before or after November 1st of the reporting year involved. Thus, beginning with the FY 2018 payment determination and for each subsequent payment determination, we finalized our policy that a new hospice be responsible for HQRP quality data submission beginning on the date of the CCN notification letter; we retained our prior policy that hospices not be subject to the APU reduction if the CCN notification letter was dated after November 1st of the year involved. For example, if a provider receives their CCN notification letter and the date in the letterhead is November 5, 2016, that provider will begin submitting HIS data for patient admissions occurring after November 5, 2016. However, since the CCN notification letter was dated after November 1st, they would not be evaluated for, or subject to any payment penalties for the relevant FY APU update (which in this instance is the FY 2018 APU, which is associated with patient admissions occurring January 1, 2016 through December 31, 2016. This policy allows us to receive HIS data on all patient admissions on or after the date that a hospice receives its CCN notification letter, while at the same time allowing hospices flexibility and time to establish the necessary accounts for data submission, before they are subject to the potential APU reduction for a given reporting year. Currently, new hospices may experience a lag between Medicare certification and receipt of their actual CCN Number. Since hospices cannot submit data to the QIES ASAP system without a valid CCN Number, we proposed that new hospices begin collecting HIS quality data beginning on the date noted on the CCN notification letter. We believe this policy will provide sufficient time for new hospices to establish appropriate collection and reporting mechanisms to submit the required quality data to CMS. Requiring quality data reporting beginning on the date listed in the letterhead of the CCN notification letter aligns CMS policy for requirements for new providers with the functionality of the HIS data submission system (QIES ASAP). c. Previously Finalized Data Submission Mechanism, Collection Timelines, and Submission Deadlines for the FY 2017 Payment Determination In the FY 2015 Hospice Wage Index final rule (79 FR 50486), we finalized our policy requiring that, for the FY 2017 reporting requirements, hospices must complete and submit HIS records VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 for all patient admissions to hospice after July 1, 2014. For each HQRP program year, we require that hospices submit data on each of the adopted measures in accordance with the reporting requirements specified in sections III.E.7c through III.E.7e of that FY 2015 Hospice Wage Index final rule for the designated reporting period. This requirement applies to previously finalized and adopted measures, as well as new measures proposed through the rulemaking process. Electronic submission is required for all HIS records. Although electronic submission of HIS records is required, hospices do not need to have an electronic medical record to complete or submit HIS data. In the FY 2014 Hospice Wage Index final rule (78 FR 48258), we finalized that to complete HIS records, providers can use either the Hospice Abstraction Reporting Tool (HART) software, which is free to download and use, or vendordesigned software. HART provides an alternative option for hospice providers to collect and maintain facility, patient, and HIS Record information for subsequent submission to the QIES ASAP system. Once HIS records are complete, electronic HIS files must be submitted to CMS via the QIES ASAP system. Electronic data submission via the QIES ASAP system is required for all HIS submissions; there are no other data submission methods available. Hospices have 30 days from a patient admission or discharge to submit the appropriate HIS record for that patient through the QIES ASAP system. We will continue to make HIS completion and submission software available to hospices at no cost. We provided details on data collection and submission timing under the downloads section of the HIS Web site on the CMS.gov Web site at https://www.cms.gov/Medicare/ Quality-Initiatives-Patient-AssessmentInstruments/Hospice-Quality-Reporting/ Hospice-Item-Set-HIS.html. The QIES ASAP system provides reports upon successful submission and processing of the HIS records. The final validation report may serve as evidence of submission. This is the same data submission system used by nursing homes, inpatient rehabilitation facilities, home health agencies, and long-term care hospitals for the submission of Minimum Data Set Version 3.0 (MDS 3.0), Inpatient Rehabilitation Facility-patient assessment instrument (IRF–PAI), Outcome Assessment Information Set (OASIS), and Long-Term Care Hospital Continuity Assessment Record and Evaluation Data Set (LTCH CARE), respectively. We have provided PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 hospices with information and details about use of the HIS through postings on the HQRP Web site, Open Door Forums, announcements in the CMS MLN Connects Provider e-News (ENews), and provider training. d. Previously Finalized Data Submission Timelines and Requirements for FY 2018 Payment Determination and Subsequent Years Hospices are evaluated for purposes of the quality reporting program based on whether or not they submit data, not on their substantive performance level for the required quality measures. In order for us to appropriately evaluate the quality reporting data received by hospice providers, it is essential HIS data be received in a timely manner. The submission date for any given HIS record is defined as the date on which a provider submits the completed record. The submission date is the date on which the completed record is submitted and accepted by the QIES ASAP system. In the FY 2016 Hospice Wage Index final rule (80 FR 47191) we finalized our policy that beginning with the FY 2018 payment determination hospices must submit all HIS records within 30 days of the Event Date, which is the patient’s admission date for HISAdmission records or discharge date for HIS-Discharge records. • For HIS-Admission records, the submission date must be no later than the admission date plus 30 calendar days. The submission date can be equal to the admission date, or no greater than 30 days later. The QIES ASAP system will issue a warning on the Final Validation Report if the submission date is more than 30 days after the patient’s admission date. • For HIS-Discharge records, the submission date must be no later than the discharge date plus 30 calendar days. The submission date can be equal to the discharge date, or no greater than 30 days later. The QIES ASAP system will issue a warning on the Final Validation Report if the submission date is more than 30 days after the patient’s discharge date. The QIES ASAP system validation edits are designed to monitor the timeliness and ensure that providers’ submitted records conform to the HIS data submission specifications. Providers are notified when timing criteria have not been met by warnings that appear on their Final Validation Reports. A standardized data collection approach that coincides with timely submission of data is essential to establish a robust quality reporting program and ensure the scientific reliability of the data received. E:\FR\FM\28APP2.SGM 28APP2 mstockstill on DSK3G9T082PROD with PROPOSALS2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules In the FY 2016 Hospice Wage Index final rule (80 FR 47191), we clarified the difference between the completion deadlines and the submission deadlines. Current sub-regulatory guidance produced by CMS (for example, HIS Manual, HIS trainings) states that the completion deadlines for HIS records are 14 days from the Event Date for HISAdmission records and 7 days from the Event Date for HIS-Discharge records. Completion deadlines continue to reflect CMS guidance only; these guidelines are not statutorily specified and are not designated through regulation. These guidelines are intended to offer clear direction to hospice agencies in regards to the timely completion of HIS-Admission and HISDischarge records. The completion deadlines define only the latest possible date on which a hospice should complete each HIS record. This guidance is meant to better align HIS completion processes with clinical workflow processes; however, hospices may develop alternative internal policies to complete HIS records. Although it is at the discretion of the hospice to develop internal policies for completing HIS records, we continue to recommend that providers complete and attempt to submit HIS records early, prior to the previously finalized submission deadline of 30 days, beginning in FY 2018. Completing and attempting to submit records early allows providers ample time to address any technical issues encountered in the QIES ASAP submission process, such as correcting fatal error messages. Completing and attempting to submit records early will ensure that providers are able to comply with the 30 day submission deadline. HQRP guidance documents, including the CMS HQRP Web site, HIS Manual, HIS trainings, Frequently Asked Questions (FAQs), and Fact Sheets continue to offer the most up-to-date CMS guidance to assist providers in the successful completion and submission of HIS records. Availability of updated guidance will be communicated to providers through the usual CMS HQRP communication channels, including postings and announcements on the CMS HQRP Web site, MLN eNews communications, National provider association calls, and announcements on Open Door Forums and Special Open Door Forums. e. Previously Finalized HQRP Data Submission and Compliance Thresholds for the FY 2018 Payment Determination and Subsequent Years To accurately analyze quality reporting data received by hospice providers, it is imperative we receive VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 ongoing and timely submission of all HIS-Admission and HIS-Discharge records. In the FY 2016 Hospice Wage Index final rule (80 FR 47192), we finalized the timeliness criteria for submission of HIS-Admission and HISDischarge records in response to input from our stakeholders seeking additional specificity related to HQRP compliance affecting FY payment determinations and, due to the importance of ensuring the integrity of quality data submitted. Last year, we finalized our policy (80 FR 47191 through 47192) that beginning with the FY 2018 payment determination and subsequent FY payment determinations, all HIS records would have to be submitted within 30 days of the event date, which is the patient’s admission date or discharge date. In conjunction with this requirement, we also finalized our policy (80 FR 47192) to establish an incremental threshold for compliance over a 3 year period. To be compliant for the FY 2018 APU determination, hospices must submit no less than 70 percent of their total number of HISAdmission and HIS-Discharge records by no later than 30 days from the event date. The timeliness threshold is set at 80 percent for the FY 2019 APU determination and at 90 percent for the FY 2020 APU determination and subsequent years. The threshold corresponds with the overall amount of HIS records received from each provider that fall within the established 30 day submission timeframes. Our ultimate goal is to require all hospices to achieve a compliance rate of 90 percent or more. To summarize, in the FY 2016 Hospice Wage Index final rule (80 FR 47193), we finalized our policy to implement the timeliness threshold requirement beginning with all HIS admission and discharge records that occur after January 1, 2016, in accordance with the following schedule. • Beginning January 1, 2016 to December 31, 2016, hospices must submit at least 70 percent of all required HIS records within the 30 day submission timeframe for the year or be subject to a 2 percentage point reduction to their market basket update for FY 2018. • Beginning January 1, 2017 to December 31, 2017, hospices must submit at least 80 percent of all required HIS records within the 30 day submission timeframe for the year or be subject to a 2 percentage point reduction to their market basket update for FY 2019. • Beginning January 1, 2018 to December 31, 2018, hospices must submit at least 90 percent of all required PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 25527 HIS records within the 30 day submission timeframe for the year or be subject to a 2 percentage point reduction to their market basket update for FY 2020. Timely submission of data is necessary to accurately analyze quality measure data received by providers. To support the feasibility of a hospice to achieve the compliance thresholds, CMS’s measure development contractor conducted some preliminary analysis of Quarter 3 and Quarter 4 HIS data from 2014. According to this analysis, the vast majority of hospices (92 percent) would have met the compliance thresholds at 70 percent. Moreover, 88 percent and 78 percent of hospices would have met the compliance thresholds at 80 percent and 90 percent, respectively. We believe this analysis is further evidence that the compliance thresholds are reasonable and achievable by hospice providers. The current reports available to providers in the Certification and Survey Provider Enhanced Reports (CASPER) system do allow providers to track the number of HIS records that are submitted within the 30 day submission timeframe. Currently, submitting an HIS record past the 30 day submission timeframe results in a non-fatal (warning) error. In April 2015, we made available 3 new Hospice Reports in CASPER, which include reports that can list HIS Record Errors by Field by Provider and HIS records with a specific error number. We are working on expanding this functionality of CASPER reports to include a timeliness compliance threshold report that providers could run to determine their preliminary compliance with the timeliness compliance requirement. We expect these reports to be available by late spring/early summer of 2016. In the FY 2016 Hospice Wage Index final rule (80 FR 47192 through 47193), we provided clarification regarding the methodology used in calculating the 70 percent/80 percent/90 percent compliance thresholds. In general, HIS records submitted for patient admissions and discharges occurring during the reporting period (January 1st to December 31st of the reporting year involved) will be included in the denominator for the compliance threshold calculation. The numerator of the compliance threshold calculation would include any records from the denominator that were submitted within the 30 day submission deadline. In the FY 2016 Hospice Wage Index final rule (80 FR 47192), we stated that we would make allowances in the calculation methodology for two (2) circumstances. First, the calculation methodology will E:\FR\FM\28APP2.SGM 28APP2 25528 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules mstockstill on DSK3G9T082PROD with PROPOSALS2 be adjusted following the applicable reporting period for records for which a hospice is granted an extension or exemption by CMS. Second, adjustments will be made for instances of modification/inactivation requests (Item A0050. Type of Record = 2 or 3). Additional helpful resources regarding the timeliness compliance threshold for HIS submissions can be found under the downloads section of the Hospice Item Set Web site at CMS.gov at https:// www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Hospice-Quality-Reporting/ Hospice-Item-Set-HIS.html. Lastly, as further details of the data submission and compliance threshold are determined by CMS, we anticipate communicating these details through the regular CMS HQRP communication channels, including postings and announcements on the CMS HQRP Web site, MLN eNews communications, National provider association calls, and announcements on Open Door Forums and Special Open Door Forums. f. New Data Collection and Submission Mechanisms Under Consideration for Future Years We have made great progress in implementing the objectives set forth in the quality reporting and data collection activities required by Sections 3004 and 3132 of the Affordable Care Act. To date, we have established the HQRP, which includes 7 NQF-endorsed quality measures that are collected via the HIS. As stated in this rule, data on these measures are expected to be publicly reported sometime in 2017. Additionally, we have implemented the Hospice CAHPS® as part of the HQRP to gather important input on patient experience of care in hospice. Over the past several years, we have conducted data collection and analysis on hospice utilization and trends to help reform the hospice payment system. In the FY 2016 Hospice Wage Index final rule, we finalized payment reform measures, including changes to the RHC payment rate and the implementation of a Service Intensity Add-On (SIA) payment, effective January 1, 2016. As part of payment reform and ongoing program integrity efforts, we will continue ongoing monitoring of utilization trends for any future refinements. To facilitate continued progress towards the requirements set forth in both sections 3004 and 3132 of the Affordable Care Act, we are considering developing a new data collection mechanism for use by hospices. This new data collection mechanism would be a hospice patient assessment instrument, which would serve 2 VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 primary objectives concordant with the Affordable Care Act legislation: (1) To provide the quality data necessary for HQRP requirements and the current function of the HIS; and (2) provide additional clinical data that could inform future payment refinements. We believe that the development of a hospice patient assessment tool could offer several benefits over the current mechanisms of data collection for quality and payment purposes, which include the submission of HIS data and the submission of claims data. For future payment refinements, a hospice patient assessment tool would allow us to gather more detailed clinical information, beyond the patient diagnosis and comorbidities that are currently reported on hospice claims. As stated in the FY 2016 Hospice Wage Index final rule (80 FR 47203), detailed patient characteristics are necessary to determine whether a case mix payment system could be achieved. A hospice patient assessment tool would allow us to capture information on symptom burden, functional status, and patient, family, and caregiver preferences, all of which will inform future payment refinements. While systematic assessment is vital throughout the continuum of care, including palliative and end-of-life care, documentation confirming completion of systematic assessment in hospice settings is often inadequate or absent.26 The value of the introduction of structured approaches via a clinical assessment is well established, as it enables a more comprehensive and consistent way of identifying and meeting patient needs.27 Moreover, symptoms are the leading reason that people seek medical care in the first place and frequently serve as the basis for establishing a diagnosis. Measures of physical function and disease burden have been used to identify older adults at high-risk for excess health care utilization, disability, or mortality.28 Currently, data collected on claims includes line-item visits by discipline, General Inpatient Care (GIP) visit reporting to hospice patients in skilled nursing facilities or hospitals, post-mortem visits, injectable and non26 McMillan, S., Small, B., & Haley, W. (2011). Improving Hospice Outcomes through Systematic Assessment: A Clinical Trial. Cancer Nursing, 34(2), 89–97. 27 Bourbonnais, F.F., Perreault, A., & Bouvette, M. (2004). Introduction of a pain and symptom assessment tool in the clinical setting—lessons learned. Journal of Nursing Management, 12(3), 194–200. 28 Sha, M., Callahan, C., Counsell, S., Westmoreland, G., Stump, T., Kroenke, K. (2005). Physical symptoms as a predictor of health care use and mortality among older adults. 118, 301–306. PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 injectable drugs and infusion pumps. Industry representatives have communicated to us that required claims information is not sufficiently comprehensive to accurately reflect the provision and the cost of hospice care. For quality data collection, a hospice patient assessment instrument would support the goals of the HQRP as new quality measures are developed and adopted. Since the current quality data collection tool (HIS) is a chart abstraction tool, not a hospice patient assessment instrument, we are limited in the types of data that can be collected via the HIS. Instead of retrospective data collection elements, a hospice patient assessment tool would include data elements designed to be collected concurrent with provision of care. As such, we believe a hospice patient assessment tool would allow for more robust data collection that could inform development of new quality measures that are meaningful to hospice patients, their families and caregivers, and other stakeholders. Finally, a hospice patient assessment tool that provides clinical data that is used for both payment and quality purposes would align the hospice benefit with other care settings that use similar approaches, such as nursing homes, inpatient rehabilitation facilities, and home health agencies which submit data via the MDS 3.0, IRF–PAI, and OASIS, respectively. We envision the hospice patient assessment tool itself as an expanded HIS. The hospice patient assessment tool would include current HIS items, as well as additional clinical items that could be used for payment refinement purposes or to develop new quality measures. The hospice patient assessment tool would not replace existing requirements set forth in the Medicare Hospice CoPs (such as the initial nursing and comprehensive assessment), but would be designed to complement data that are collected as part of normal clinical care. If such a patient assessment were adopted, the new data collection effort would replace the current HIS, but would not replace other HQRP data collection efforts (that is, the Hospice CAHPS® survey), nor would it replace regular submission of claims data. We envision that patient assessment data would be collected upon a patient’s admission to and discharge from any Medicare-certified hospice provider; additional interim data collection efforts are also possible. If we develop and implement a hospice patient assessment tool, we would provide several training opportunities to ensure providers are able to comply with any new requirements. E:\FR\FM\28APP2.SGM 28APP2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules mstockstill on DSK3G9T082PROD with PROPOSALS2 We are not proposing a hospice patient assessment tool at this time; we are still in the early stages of development of an assessment tool to determine if it would be feasible to implement under the Medicare Hospice Benefit. In the development of such a hospice patient assessment tool, we will continue to receive stakeholder input from MedPAC and ongoing input from the provider community, Medicare beneficiaries, and technical experts. It is of the utmost importance to develop a hospice patient assessment tool that is scientifically rigorous and clinically appropriate, thus we believe that continued and transparent involvement of stakeholders is critical. Additionally, it is of the utmost importance to minimize data collection burden on providers; in the development of any hospice patient assessment tool, we will ensure that patient assessment data items are not duplicative or overly burdensome to providers, patients, caregivers, or their families. We solicit comments on a potential hospice patient assessment tool that would collect both quality, clinical, and other data with the ability to be used to inform future payment refinement efforts. 8. HQRP Submission Exemption and Extension Requirements for the FY 2017 Payment Determination and Subsequent Years In the FY 2015 Hospice Wage Index final rule (79 FR 50488), we finalized our proposal to allow hospices to request, and for us to grant exemptions/ extensions for the reporting of required HIS quality data when there are extraordinary circumstances beyond the control of the provider. When an extension/exemption is granted, a hospice will not incur payment reduction penalties for failure to comply with the requirements of the HQRP. For the FY 2016 payment determination and subsequent payment determinations, a hospice may request an extension/ exemption of the requirement to submit quality data for a specified time period. In the event that a hospice requests an extension/exemption for quality reporting purposes, the hospice would submit a written request to CMS. In general, exemptions and extensions will not be granted for hospice vendor issues, fatal error messages preventing record submission, or staff error. In the event that a hospice seeks to request an exemptions or extension for quality reporting purposes, the hospice must request an exemption or extension within 30 days of the date that the extraordinary circumstances occurred by submitting the request to CMS via VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 email to the HQRP mailbox at HospiceQRPReconsiderations@ cms.hhs.gov. Exception or extension requests sent to CMS through any other channel will not be considered valid. The request for an exemption or extension must contain all of the finalized requirements as outlined on our Web site at https://www.cms.gov/ Medicare/Quality-Initiatives-PatientAssessment-Instruments/HospiceQuality-Reporting/Extensions-andExemption-Requests.html. If a hospice is granted an exemption or extension, timeframes for which an exemption or extension is granted will be applied to the new timeliness requirement so such hospices are not penalized. If a hospice is granted an exemption, we will not require that the hospice submit any quality data for a given period of time. By contrast, if we grant an extension to a hospice, the hospice will still remain responsible for submitting quality data collected during the timeframe in question, although we will specify a revised deadline by which the hospice must submit these quality data. This process does not preclude us from granting extensions/exemptions to hospices that have not requested them when we determine that an extraordinary circumstance, such as an act of nature, affects an entire region or locale. We may grant an extension/ exemption to a hospice if we determine that a systemic problem with our data collection systems directly affected the ability of the hospice to submit data. If we make the determination to grant an extension/exemption to hospices in a region or locale, we will communicate this decision through routine CMS HQRP communication channels, including postings and announcements on the CMS HQRP Web site, MLN eNews communications, National provider association calls, and announcements on Open Door Forums and Special Open Door Forums. 9. Hospice CAHPS® Participation Requirements for the 2019 APU and 2020 APU National Implementation of the Hospice CAHPS® Survey started January 1, 2015 as stated in the FY 2015 Hospice Wage Index and Payment Rate Update final rule (79 FR 50452). The CAHPS® Hospice Survey is a component of CMS’ Hospice Quality Reporting Program that emphasizes the experiences of hospice patients and their primary caregivers listed in the hospice patients’ records. Readers who want more information are referred to our extensive discussion of the Hospice Experience of Care Survey in the PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 25529 Hospice Wage Index FY 2015 final rule for a description of the measurements involved and their relationship to the statutory requirement for hospice quality reporting (79 FR 50450 and 78 FR 48261). a. Background and Description of the Survey The CAHPS® Hospice Survey is the first national hospice experience of care survey that includes standard survey administration protocols that allow for fair comparisons across hospices. Consistent with many other CMS CAHPS® surveys that are publicly reported on CMS Web sites, we will publicly report hospice data when at least 12 months of data are available, so that valid comparisons can be made across hospice providers in the United States, in order to help patients, family, friends, and caregivers choose the right hospice program. The goals of the CAHPS® Hospice Survey are to: • Produce comparable data on hospice patients’ and caregivers’ perspectives of care that allow objective and meaningful comparisons between hospices on domains that are important to consumers. • Create incentives for hospices to improve their quality of care through public reporting of survey results. • Hold hospice care providers accountable by informing the public about the providers’ quality of care. Details regarding CAHPS® Hospice Survey national implementation, and survey administration as well as participation requirements, exemptions from the survey requirement, hospice patient and caregiver eligibility criteria, fielding schedules, sampling requirements, and the languages in which is questionnaire, are available on the CAHPS® Web site, www.HospiceCAHPSsurvey.org and in the Quality Assurance Guidelines (QAG) manual, which is also on the same site and is available for download. Measures from the survey will be submitted to the NQF for endorsement. b. Participation Requirements To Meet Quality Reporting Requirements for the FY 2019 APU To meet participation requirements for the FY 2019 APU, hospices must collect survey data on an ongoing monthly basis from January 2017 through December 2017 (inclusive). Data submission deadlines for the 2019 APU can be found in Table 17. The data must be submitted by the deadlines listed in Table 17 by the hospice’s authorized approved CMS vendor. E:\FR\FM\28APP2.SGM 28APP2 25530 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules Hospices provide lists of the patients who died under their care to form the sample for the Hospice CAHPS® Survey. We emphasize the importance of hospices providing complete and accurate information to their vendors in a timely manner. Hospices must contract with an approved Hospice CAHPS® Survey vendor to conduct the survey on their behalf. The hospice is responsible for making sure their vendor meets all data submission deadlines. Vendor failure to submit data on time will be the responsibility of the hospice. TABLE 17—CAHPS® HOSPICE SURVEY DATA SUBMISSION DATES FY 2018 APU, FY 2019 APU, AND FY 2020 APU Quarterly data submission deadlines 2 Sample months (that is, month of death) 1 FY 2018 APU January–March 2016 (Q1) ....................................................................................................................................................... April–June 2016 (Q2) .............................................................................................................................................................. July–September 2016 (Q3) ..................................................................................................................................................... October–December 2016 (Q4) ................................................................................................................................................ August 10, 2016. November 9, 2016. February 8, 2017. May 10, 2017. FY 2019 APU January–March 2017 (Q1) ....................................................................................................................................................... April–June 2017 (Q2) .............................................................................................................................................................. July–September 2017 (Q3) ..................................................................................................................................................... October–December 2017 (Q4) ................................................................................................................................................ August 9, 2017. November 8, 2017. February 14, 2018. May 9, 2018. FY 2020 APU January–March 2018 (Q1) ....................................................................................................................................................... April–June 2018 (Q2) .............................................................................................................................................................. July–September 2018 (Q3) ..................................................................................................................................................... October–December 2018 (Q4) ................................................................................................................................................ August 8, 2018. November 14, 2018. February 13, 2019. May 8, 2019. mstockstill on DSK3G9T082PROD with PROPOSALS2 1 Data collection for each sample month initiates 2 months following the month of patient death (for example, in April for deaths occurring in January). 2 Data submission deadlines are the second Wednesday of the submission months, which are August, November, February, and May. 2 Data submission deadlines are the second Wednesday of the submission months, which are August, November, February, and May. Hospices that have fewer than 50 survey-eligible decedents/caregivers in the period from January 1, 2016 through December 31, 2016 are exempt from CAHPS® Hospice Survey data collection and reporting requirements for the FY 2019 payment determination. To qualify, hospices must submit an exemption request form. This form will be available in first quarter 2017 on the CAHPS® Hospice Survey Web site https://www.hospiceCAHPSsurvey.org. Hospices that want to claim the size exemption are required to submit to CMS their total unique patient count for the period of January 1, 2016 through December 31, 2016. The due date for submitting the exemption request form for the FY 2019 APU is August 10, 2017. We propose that hospices that received their CCN after January 1, 2017, are exempted from the FY 2019 APU Hospice CAHPS® requirements due to newness. This exemption will be determined by CMS. The exemption is for 1 year only. c. Participation Requirements To Meet Quality Reporting Requirements for the FY 2020 APU To meet participation requirements for the FY 2020 APU, hospices must collect survey data on an ongoing monthly basis from January 2018 VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 through December 2018 (inclusive). Data submission deadlines for the 2020 APU can be found in Table 17. The data must be submitted by the deadlines in Table 17 by the hospice’s authorized approved CMS vendor. Hospices must contract with an approved Hospice CAHPS® survey vendor to conduct the survey on their behalf. The hospice is responsible for making sure their vendor meets all data submission deadlines. Vendor failure to submit data on time will be the responsibility of the hospice. Hospices that have fewer than 50 survey-eligible decedents/caregivers in the period from January 1, 2017 through December 31, 2017 are exempt from CAHPS® Hospice Survey data collection and reporting requirements for the FY 2020 payment determination. To qualify, hospices must submit an exemption request form. This form will be available in first quarter 2018 on the CAHPS® Hospice Survey Web site https://www.hospiceCAHPSsurvey.org. Hospices that want to claim the size exemption are required to submit to CMS their total unique patient count for the period of January 1, 2017 through December 31, 2017. The due date for submitting the exemption request form for the FY 2020 APU is August 10, 2018. PO 00000 Frm 00034 Fmt 4701 Sfmt 4702 We propose that hospices that received their CCN after January 1, 2018, are exempted from the FY 2020 APU Hospice CAHPS® requirements due to newness. This exemption will be determined by CMS. The exemption is for 1 year only. d. Annual Payment Update The Affordable Care Act requires that beginning with FY 2014 and each subsequent fiscal year, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements for that fiscal year, unless covered by specific exemptions. Any such reduction will not be cumulative and will not be taken into account in computing the payment amount for subsequent fiscal years. In the FY 2015 Hospice Wage Index final rule, we added the CAHPS® Hospice Survey to the Hospice Quality Reporting Program requirements for the FY 2017 payment determination and determinations for subsequent years. • To meet the HQRP requirements for the FY 2018 payment determination, hospices would collect survey data on a monthly basis for the months of January 1, 2016 through December 31, 2016 to qualify for the full APU. E:\FR\FM\28APP2.SGM 28APP2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules • To meet the HQRP requirements for the FY 2019 payment determination, hospices would collect survey data on a monthly basis for the months of January 1, 2017 through December 31, 2017 to qualify for the full APU. • To meet the HQRP requirements for the FY 2020 payment determination, hospices would collect survey data on a monthly basis for the months of January 1, 2018 through December 31, 2018 to qualify for the full APU. mstockstill on DSK3G9T082PROD with PROPOSALS2 e. Hospice CAHPS® Reconsiderations and Appeals Process Hospices are required to monitor their respective Hospice CAHPS® Survey vendors to ensure that vendors submit their data on time. The hospice CAHPS® data warehouse provides reports to vendors and hospices, including reports on the status of their data submissions. Details about the reports and emails received after data submission should be referred to the Quality Assurance Guidelines Manual. If a hospice does not know how to retrieve their reports, or lacks access to the reports, they should contact Hospice CAHPS® Technical Assistance at hospiceCAHPSsurvey@hcqis.org or call them at 1–844 –472–4621. Additional information can be found on page 113 of the Hospice CAHPS® Quality Assurance Guidelines manual Version 2.0 which is available on the Hospice CAHPS® Web site, www.hospicecahpssurvey.org. In the FY 2017 payment determination and subsequent years, reporting compliance is determined by successfully fulfilling both the Hospice CAHPS® Survey requirements and the HIS data submission requirements. Providers would use the same process for submitting a reconsideration request that are outlined in section III.C.10 of this proposed rule. 10. HQRP Reconsideration and Appeals Procedures for the FY 2017 Payment Determination and Subsequent Years In the FY 2015 Hospice Wage Index final rule (79 FR 50496), we notified hospice providers on how to seek reconsideration if they received a noncompliance decision for the FY 2016 payment determination and subsequent years. A hospice may request reconsideration of a decision by CMS that the hospice has not met the requirements of the Hospice Quality Reporting Program for a particular period. For the FY 2017 payment determination and subsequent years, reporting compliance is determined by successfully fulfilling both the Hospice CAHPS® Survey requirements and the HIS data submission requirements. VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 We clarified that any hospice that wishes to submit a reconsideration request must do so by submitting an email to CMS containing all of the requirements listed on the HQRP Web site at https://www.cms.gov/Medicare/ Quality-Initiatives-Patient-AssessmentInstruments/Hospice-Quality-Reporting/ Reconsideration-Requests.html. Electronic email sent to HospiceQRPReconsiderations@ cms.hhs.gov is the only form of submission that will be accepted. Any reconsideration requests received through any other channel including the United States Postal Service or phone will not be considered as a valid reconsideration request. We codified this process at § 418.312(h). In addition, we codified at § 418.306(b)(2) that beginning with FY 2014 and each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements for that FY and solicited comments on all of the proposals and the associated regulations text at § 418.312 and in § 418.306. Official instructions regarding the payment reduction reconsideration process can be located under the Regulations and Guidance, Transmittals, 2015 Transmittals Web site at https:// www.cms.gov/Regulations-andGuidance/Guidance/Transmittals/2015Transmittals-Items/R52QRI.html ?DLPage=1&DLEntries=10&DLSort=4& DLSortDir=descending. In the past, only hospices found to be non-compliant with the reporting requirements set forth for a given payment determination received a notification from CMS of this finding along with instructions for requesting reconsideration in the form of a United States Postal Service (USPS) letter. In the FY 2016 Hospice Wage Index final rule (80 FR 47198), we proposed to use the QIES CASPER reporting system as an additional mechanism to communicate to hospices regarding their compliance with the reporting requirements for the given reporting cycle. We will implement this additional communication mechanism via the QIES CASPER timeliness compliance reports. As stated in section III.E.7e, of this proposed rule these QIES CASPER reports will be automated reports that hospices will be able to generate at any point in time to determine their preliminary compliance with HQRP requirements, specifically, the timeliness compliance threshold for the HIS. We believe the QIES CASPER timeliness compliance reports meet our intent of developing a method to PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 25531 communicate as quickly, efficiently, and broadly as possible with hospices regarding their preliminary compliance with reporting requirements. We will continue to send notification of noncompliance via delivery of a letter via the United States Postal Service. Requesting access to the CMS systems is performed in 2 steps. Details are provided on the QIES Technical Support Office Web site at https://www. qtso.com/hospice.html. Providers may access the CMS QIES Hospice Users Guides and Training on the QIES Technical Support Office Web site and selecting Hospice and then selecting the CASPER Reporting Users Guide at https://www.qtso.com/hospice train.html. Additional information about how to access the QIES CASPER reports will be provided prior to the availability of these new reports. We proposed to disseminate communications regarding the availability of hospice compliance reports in CASPER files through CMS HQRP communication channels, including postings and announcements on the CMS HQRP Web site, MLN eNews communications, National provider association calls, and announcements on Open Door Forums and Special Open Door Forums. We further proposed to publish a list of hospices who successfully meet the reporting requirements for the applicable payment determination on the CMS HQRP Web site https://www. cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/ Hospice-Quality-Reporting/. We proposed updating the list after reconsideration requests are processed on an annual basis. We clarified that the published list of compliant hospices on the CMS HQRP Web site would include limited organizational data, such as the name and location of the hospice. Finalizing the list of compliant providers for any given year is most appropriately done after the final determination of compliance is made. It is our intent for the published list of compliant hospices to be as complete and accurate as possible, giving recognition to all providers who were compliant with HQRP requirements for that year. Finalizing the list after requests for reconsideration are reviewed and a final determination of compliance is made allows for a more complete and accurate listing of compliant providers than developing any such list prior to reconsideration. Developing the list after the final determination of compliance has been made allows providers whose initial determination of noncompliance was E:\FR\FM\28APP2.SGM 28APP2 25532 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules mstockstill on DSK3G9T082PROD with PROPOSALS2 reversed to be included in the list of compliant hospices for that year. We believe that finalizing the list of compliant hospices annually, after the reconsideration period will provide the most accurate listing of hospices compliant with HQRP requirements. 11. Public Display of Quality Measures and Other Hospice Data for the HQRP Under section 1814(i)(5)(E) of the Act, the Secretary is required to establish procedures for making any quality data submitted by hospices available to the public. Such procedures shall ensure that a hospice program has the opportunity to review the data that is to be made public for the hospice program prior to such data being made public. The Secretary shall report quality measures that relate to hospice care provided by hospice programs on the CMS Web site. We recognize that public reporting of quality data is a vital component of a robust quality reporting program and are fully committed to developing the necessary systems for transparent public reporting of hospice quality data. We also recognize that it is essential that the data made available to the public be meaningful and that comparing performance between hospices requires that measures be constructed from data collected in a standardized and uniform manner. Hospices have been required to use a standardized data collection approach (HIS) since July 1, 2014. Data from July 1, 2014 onward is currently being used to establish the scientific soundness of the quality measures prior to the onset of public reporting of the 7 quality measures implemented in the HQRP. We believe it is critical to establish the reliability and validity of the quality measures prior to public reporting to demonstrate the ability of the quality measures to distinguish the quality of services provided. To establish reliability and validity of the quality measures, at least 4 quarters of data will be analyzed. Typically, the first 1 or 2 quarters of data reflect the learning curve of the facilities as they adopt standardized data collection procedures; these data often are not used to establish reliability and validity. We began data collection in CY 2014; the data from CY 2014 for Quarter 3 (Q3) was not used for assessing validity and reliability of the quality measures. We analyzed data collected by hospices during Quarter 4 (Q4) CY 2014 and Q1– Q3 CY 2015. Preliminary analyses of HIS data show that all 7 quality measures that can be calculated using HIS data are eligible for public reporting (NQF #1634, NQF #1637, NQF #1639, NQF #1638, NQF #1641, modified NQF VerDate Sep<11>2014 22:19 Apr 27, 2016 Jkt 238001 #1647, NQF #1617). Based on analyses conducted to establish reportability of the measures, 71 percent–90 percent of all hospices would be able to participate in public reporting, depending on the measure. For additional details regarding analysis, we refer readers to the Measure Testing Executive Summary document available on the ‘‘Current Measures’’ section of the CMS HQRP Web site: https://www.cms.gov/ Medicare/Quality-Initiatives-PatientAssessment-Instruments/HospiceQuality-Reporting/CurrentMeasures.html. Although analyses show that many hospices perform well on the 7 measures from the HIS measure set, the measures still show variation, especially among hospices with suboptimal performance, indicating that these measures are still meaningful for comparing quality of care across hospice providers. In addition to conducting quantitative analysis to establish scientific acceptability of the HIS measures, CMS’s measure development contractor, RTI International, also conducted interviews with family and caregivers of hospice patients. The purpose of these interviews was to determine what information patients and caregivers would find useful in selecting hospices, as well as gathering input about patient and caregiver experience with hospice care. Results from these interviews indicate that all 7 HIS quality measures provide consumers with useful information. Interview participants stated that quality measure data would be especially helpful in identifying poor quality outliers that inform beneficiaries, families, caregivers, and other hospice stakeholders. To inform which of the HIS measures are eligible for public reporting, CMS’s measure development contractor, RTI International, examined the distribution of hospice-level denominator size for each quality measure to assess whether the denominator size is large enough to generate the statistically reliable scores necessary for public reporting. This goal of this analysis is to establish the minimum denominator size for public reporting, and is referred to as ‘‘reportability’’ analysis. Reportability analysis is necessary since small denominators may not yield statistically meaningful QM scores. Thus, for other quality reporting programs, such as Nursing Home Compare,29 CMS sets a minimum denominator size for public reporting, as well as the data selection 29 ‘‘CMS Nursing Home Quality Initiative— Centers for Medicare* * *’’ 2011. 25 Jan. 2016, https://www.cms.gov/nursinghomequalityinits/ 45_nhqimds30trainingmaterials.asp. PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 period necessary to generate the minimum denominator size. Reportability analysis showed that calculating and publicly displaying measures based on 12 months of data would allow for sufficient measure denominator size. Having ample denominator size ensures that quality measure scores that are publicly reported are reliable and stable; a minimum sample size of 20 stays is commonly applied to assessment-based quality measures in other reporting programs. The 12 month data selection period produced significantly larger mean and median sample sizes among hospices, which will generate more reliable quality measure scores. Additionally, our analysis revealed that when applying a minimum sample size of 20 stays, using rolling 12 months of data to create QMs would only exclude about 10 percent¥29 percent of hospices from public reporting, depending on the measure. For more information on analyses conducted to determine minimum denominator size and data selection period, we refer readers to the Reportability Analysis Section of the Measure Testing Executive Summary, available on the ‘‘Current Measures’’ portion of the CMS HQRP Web site: https://www.cms.gov/ Medicare/Quality-Initiatives-PatientAssessment-Instruments/HospiceQuality-Reporting/CurrentMeasures.html. Based on reportability analysis and input from other stakeholders, we have determined that all 7 HIS measures are eligible for public reporting. Thus, we plan to publicly report all 7 HIS measures on a CMS Compare Web site for hospice agencies. For more details on each of the 7 measures, including information on measure background, justification, measure specifications, and measure calculation algorithms, we refer readers to the HQRP QM User’s Manual v1.00 Final document, which is available on the downloads portion of the Hospice Item Set Web site, CMS HQRP Web site: https://www.cms.gov/ Medicare/Quality-Initiatives-PatientAssessment-Instruments/HospiceQuality-Reporting/CurrentMeasures.html. Individual scores for each of the 7 HIS measure scores would be reported on a new publicly available CMS Hospice Compare Web site. Current reportability analysis indicates that a minimum denominator size of 20 based on 12 rolling months of data would be sufficient for public reporting of all HIS quality measures. Under this methodology, hospices with a quality measure denominator size of smaller than 20 patient stays would not have the E:\FR\FM\28APP2.SGM 28APP2 mstockstill on DSK3G9T082PROD with PROPOSALS2 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules quality measure score publicly displayed since a quality measure score on the basis of small denominator size may not be reliable. We will continue to monitor quality measure performance and reportability and will adjust public reporting methodology in the future if needed. Reportability analysis is typically conducted on a measure-by-measure basis. We would like to clarify that any new measure adopted as part of the HQRP will undergo reportability analysis to determine: (1) if the measure is eligible for public reporting; and (2) the data selection period and minimum denominator size for the measure. Results of reportability analyses conducted for new measures will be communicated through future rulemaking. In addition, the Affordable Care Act requires that reporting be made public on a CMS Web site and that providers have an opportunity to review their data prior to public reporting. We are currently developing the infrastructure for public reporting, and will provide hospices an opportunity to review their quality measure data prior to publicly reporting information about the quality of care provided by Medicare-certified hospice agencies throughout the nation. These quality measure data reports or ‘‘preview reports’’ will be made available in the CASPER system prior to public reporting and will offer providers the opportunity to review their quality measure data prior to public reporting on the CMS Compare Web site for hospice agencies. Under this process, providers would have the opportunity to review and correct data they submit on all measures that are derived from the HIS. Reports would contain the provider’s performance on each measure calculated based on HIS submission to the QIES ASAP system. The data from the HIS submissions would be populated into reports with all data that have been submitted by the provider. We will post preview reports with sufficient time for providers to be able to submit, review data, make corrections to the data, and view their data. Providers are encouraged to regularly evaluate their performance in an effort to ensure the most accurate information regarding their agency is reflected. We also plan to make available additional provider-level feedback reports, which are separate from public reporting and will be for provider viewing only, for the purposes of internal provider quality improvement. As is common in other quality reporting programs, quality reports would contain feedback on facility-level performance on quality metrics, as well as VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 benchmarks and thresholds. For the CY 2015 Reporting Cycle, several new quality reporting provider participation reports were made available in CASPER. Providers can access a detailed list and description of each of the 12 reports currently available to hospices on the QIES Web site, under the Training and Education Selections, CASPER Reporting Users Guide at https://www. qtso.com/hospicetrain.html. We anticipate that providers would use the quality reports as part of their Quality Assessment and Performance Improvement (QAPI) efforts. Furthermore, to meet the requirement for making such data public, we are developing a CMS Hospice Compare Web site, which will provide valuable information regarding the quality of care provided by Medicare-certified hospice agencies throughout the nation. Consumers would be able to search for all Medicare approved hospice providers that serve their city or zip code (which would include the quality measures and CAHPS® Hospice Survey results) and then find the agencies offering the types of services they need, along with provider quality information. Based on the efforts necessary to build the infrastructure for public reporting, we anticipate that public reporting of the eligible HIS quality measures on the CMS Compare Web site for hospice agencies will begin sometime in the spring/summer of CY 2017. To help providers prepare for public reporting, we will offer opportunities for stakeholder engagement and education prior to the rollout of a Hospice Compare site. We will offer outreach opportunities for providers through the MLN eNews, Open Door Forums and Special Open Door Forums; we will also post additional educational materials regarding public reporting on the CMS HQRP Web site. Finally, we will offer training to all hospice providers on the systems and processes for reviewing their data prior to public reporting; availability of trainings will be communicated through the regular CMS HQRP communication channels, including postings and announcements on the CMS HQRP Web site, MLN eNews communications, National provider association calls, and announcements on Open Door Forums and Special Open Door Forums. Like other CMS Compare Web sites, the Hospice Compare Web site will, in time, feature a quality rating system that gives each hospice a rating of between 1 and 5 stars. Hospices will have prepublication access to their own agency’s quality data, which enables each agency to know how it is performing before public posting of data PO 00000 Frm 00037 Fmt 4701 Sfmt 4702 25533 on the Hospice Compare Web site. Public comments regarding how the rating system would determine a hospice’s star rating and the methods used for calculations, as well as a proposed timeline for implementation will be announced via regular CMS HQRP communication channels, including postings and announcements on the CMS HQRP Web site, MLN eNews communications, provider association calls, and announcements on Open Door Forums and Special Open Door Forums. We will announce the timeline for development and implementation of the star rating system in future rulemaking. Lastly, as part of our ongoing efforts to make healthcare more transparent, affordable, and accountable for all hospice stakeholders, the HQRP is prepared to post hospice data on a public data set, the Data.Medicare.gov Web site, and directory located at https://data.medicare.gov. This site includes the official datasets used on the Medicare.gov Compare Web sites provided by CMS. In addition, this data will serve as a helpful resource regarding information on Medicarecertified hospice agencies throughout the nation. In an effort to move toward public reporting of hospice data, we will initially post demographic data of hospice agencies that have been registered with Medicare. This list will include addresses, phone numbers, and services provided for each agency. The timeline for posting hospice demographic data on a public dataset is scheduled for sometime late spring/ summer CY 2016. Additional details regarding hospice datasets will be announced via regular CMS HQRP communication channels, including postings and announcements on the CMS HQRP Web site, MLN eNews communications, National provider association calls, and announcements on Open Door Forums and Special Open Door Forums. In addition, we will provide the applicable list of CASPER/ ASPEN coordinators in the event the Medicare-certified agency is either not listed in the database or the characteristics/administrative data (name, address, phone number, services, or type of ownership) is incorrect or has changed. To continue to meet Medicare enrollment requirements, all Medicare providers are required to report changes to their information in their enrollment application as outlined in the Provider -Supplier Enrollment Fact Sheet Series located at https://www.cms.gov/ Outreach-and-Education/MedicareLearning-Network-MLN/MLNProducts/ E:\FR\FM\28APP2.SGM 28APP2 25534 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules downloads/MedEnroll_InstProv_Fact Sheet_ICN903783.pdf. D. The Medicare Care Choices Model The Medicare Care Choices Model (MCCM) offers a new option for Medicare 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 5 year model is being tested to encourage greater and earlier use of the Medicare and Medicaid hospice benefit to determine whether it can improve the quality of life and care received by Medicare beneficiaries, increase beneficiary, family, and caregiver satisfaction, and reduce Medicare or Medicaid expenditures. Participation in the model will be limited to Medicare and dual eligible beneficiaries with advanced cancers, chronic obstructive pulmonary disease (COPD), congestive heart failure, and Human Immunodeficiency Virus/ Acquired Immune Deficiency Syndrome who qualify for the Medicare or Medicaid hospice benefit and meet the eligibility requirements of the model. The model includes over 130 hospices from 39 states across the country and is projected to serve 100,000 beneficiaries by 2020. The first cohort of MCCM participating hospices began providing services under the model in January 2016, and the second cohort will begin to provide services under the model in January 2018. The last patient will be accepted into the model 6 months before the December 31, 2020 model end date. For more information, see the MCCM Web site: https://innovation.cms.gov/ initiatives/Medicare-Care-Choices/. mstockstill on DSK3G9T082PROD with PROPOSALS2 IV. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. To fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues: • The need for the information collection and its usefulness in carrying out the proper functions of our agency. • The accuracy of our estimate of the information collection burden. VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 • The quality, utility, and clarity of the information to be collected. • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comment on each of the following information collection requirements (ICRs). A. Proposed Information Collection Requirements Section 1814(i)(5)(C) of the Act requires that each hospice submit data to the Secretary on quality measures specified by the Secretary. Such data must be submitted in a form and manner, and at a time specified by the Secretary. In the FY 2014 Hospice Wage Index final rule (78 FR 48257), and in compliance with section 1814(i)(5)(C) of the Act, we finalized the specific collection of data items that support the following six NQF endorsed measures and one modified measure for hospice: • NQF #1617 Patients Treated with an Opioid who are Given a Bowel Regimen, • NQF #1634 Pain Screening, • NQF #1637 Pain Assessment, • NQF #1638 Dyspnea Treatment, • NQF #1639 Dyspnea Screening, • NQF #1641 Treatment Preferences, • NQF #1647 Beliefs/Values Addressed (if desired by the patient) (modified). Data for the aforementioned 7 measures is collected via the HIS. Data collection for the 7 NQF-endorsed measures via the HIS V1.00.0 was approved by the Office of Management and Budget April 3, 2014 (OMB control number 0938–1153—Hospice Quality Reporting Program). As outlined in this proposed rule, we continue data collection for these 7 NQF-endorsed measures. In this proposed rule, we propose the implementation of two new measures. The first measure is the Hospice and Palliative Care Composite Process Measure—Comprehensive Assessment at Admission. Seven individual care processes will be captured in this composite measure, which includes the six NQF-endorsed quality measures and one modified NQF-endorsed quality measure currently implemented in the HQRP. Thus, the Hospice and Palliative Care Composite Process quality measure will use the current HQRP quality measures as its components. The data source for this measure will be currently implemented HIS items that are currently used in the calculation of the seven component measures. Since the proposed measure is a composite measure created from components, which are currently adopted HQRP PO 00000 Frm 00038 Fmt 4701 Sfmt 4702 measures, no new data collection will be required; data for the composite measure will come from existing items from the existing seven HQRP component measures. We propose to begin calculating this measure using existing data items, beginning April 1, 2017; this means patient admissions occurring on or after April 1, 2017, would be included in the composite measure calculation. The second measure is the Hospice Visits when Death is Imminent Measure Pair. Data for this measure would be collected via the existing data collection mechanism, the HIS. We proposed that four new items be added to the HISDischarge record to collect the necessary data elements for this measure. We expect that data collection for this quality measure via the four 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 on or after April 1, 2017. We proposed the HIS V2.00.0 to fulfill the data collection requirements for the 7 currently adopted NQF measures and the 2 new proposed measures. The HIS V2.00.0 contains: • All items from the HIS V1.00.0, which are necessary to calculate the 7 adopted NQF measures (and thus the proposed composite measure), plus the HIS V1.00.0 administrative items necessary for patient identification and record matching • One new item for measure refinement of the existing measure NQF #1637 Pain Assessment. • New items to collect data for the Hospice Visits when Death is Imminent measure pair. • New administrative items for patient record matching and future public reporting of hospice quality data. Hospice providers will submit an HISAdmission and an HIS-Discharge for each patient admission. Using HIS data for assessments submitted October 1, 2014 through September 30, 2015, we have estimated that there will be approximately 1,248,419 discharges across all hospices per year; therefore, we would expect that there should be 1,248,419 HIS (consisting of one admission and one discharge assessment per patient), submitted across all hospices yearly. Over a 3-year period, we expect 3,745,257 Hospice Item Sets across all hospices. There were 4,259 certified hospices in the United States as of January 2016; 30 we estimate that each individual hospice 30 Quality Improvement and Evaluation System (QIES) List of Hospice Providers, January 2016. E:\FR\FM\28APP2.SGM 28APP2 25535 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules will submit on average 293 Hospice Item Sets annually, which is approximately 24 Hospice Items Sets per month or 879 Hospice Item Sets over three years. The HIS consists of an admission assessment and a discharge assessment. As noted above, we estimate that there will be 1,248,419 hospice admissions across all hospices per year. Therefore, we expect there to be 2,496,838 HIS assessment submissions (admission and discharge assessments counted separately) submitted across all hospices annually, which is 208,070 across all hospices monthly, or 7,490,514 across all hospices over 3 years. We further estimate that there will be 586 Hospice Item Set submissions by each hospice annually, which is approximately 49 submissions monthly or 1,759 submissions over 3 years. For the Admission Hospice Item Set, we estimate that it will take 14 minutes of time by a clinician such as a Registered Nurse at an hourly wage of $67.10 31 to abstract data for Admission Hospice Item Set. This would cost the facility approximately $15.66 for each admission assessment. We further estimate that it will take 5 minutes of time by clerical or administrative staff person such as a medical data entry clerk or medical secretary at an hourly wage of $32.24 32 to upload the Hospice Item Set data into the CMS system. This would cost each facility approximately $2.69 per assessment. For the Discharge Hospice Item Set, we estimate that it will take 9 minutes of time by a clinician, such as a nurse at an hourly wage of $67.10 to abstract data for Discharge Hospice Item Set. This would cost the facility approximately $10.07. We further estimate that it will take 5 minutes of time by clerical or administrative staff, such as a medical data entry clerk or medical secretary at an hourly wage of $32.24 to upload data into the CMS system. This would cost each facility approximately $2.69. The estimated cost for each full Hospice Item Set submission (admission assessment and discharge assessment) is $31.10. We estimate that the total nursing time required for completion of both the admission and discharge assessments is 23 minutes at a rate of $67.10 per hour. The cost across all Hospices for the nursing/clinical time required to complete both the admission and discharge Hospice Item sets is estimated to be $32,111,417 annually, or $96,334,252 over 3 years, and the cost to each individual Hospice is estimated to be $7,539.66 annually, or $22,618.98 over 3 years. The estimated time burden to hospices for a medical data entry clerk to complete the admission and discharge Hospice Item Set assessments is 10 minutes at a rate of $32.24 per hour. The cost for completion of the both the admission and discharge Hospice Item sets by a medical data entry clerk is estimated to be $6,708,171 across all Hospices annually, or $20,124,514 across all Hospices over 3 years, and $1,575.06 to each Hospice annually, or $4,725.17 to each Hospice over 3 years. The total combined time burden for completion of the Admission and Discharge Hospice Item Sets is estimated to be 33 minutes. The total cost across all hospices is estimated to be $38,819,589 annually or $116,458,766 over 3 years. For each individual hospice, this cost is estimated to be $9,114.72 annually or $27,344.16 over 3 years. See Table 17 for breakdown of burden and cost by assessment form. TABLE 17—SUMMARY OF BURDEN HOURS AND COSTS Number of responses 4,259 1,248,419 per year. 0938–1153 4,259 1,248,419 per year. 0938–1153 4,259 7,490,514 ..... 0.233 clinician hours; 0.083 clerical hours. 0.150 clinician hours; 0.083 clerical hours. 0.55 hours ............. OMB control No. Number of respondents Hospice Item Set Admission Assessment. 0938–1153 Hospice Item Set Discharge Assessment. 3-year total ..................... 395,333 291,298 2,059,891 Hourly labor cost of reporting ($) Total cost ($) Clinician at $67.10 per hour; Clerical staff at $32.24 per hour. Clinician at $67.10 per hour; Clerical staff at $32.24 per hour. Clinician at $67.10 per hour; Clerical staff at $32.24 per hour. $22,900,166 15,919,423 116,458,766 V. Economic Analyses We have submitted a copy of this proposed rule to OMB for its review of the rule’s information collection and recordkeeping requirements. These requirements are not effective until they have been approved by the OMB. To obtain copies of the supporting statement and any related forms for the proposed collections discussed above, please visit CMS’ Web site at www.cms. hhs.gov/Paperwork@cms.hhs.gov, or call the Reports Clearance Office at 410– 786–1326. We invite public comments on these potential information collection requirements. If you wish to comment, please submit your comments electronically as specified in the ADDRESSES section of this proposed rule and identify the rule (CMS–1652–P) the ICR’s CFR citation, CMS ID number, and OMB control number. ICR-related comments are due June 27, 2016. 31 The adjusted hourly wage of $67.10 per hour for a Registered Nurse was obtained using the mean hourly wage from the U.S. Bureau of Labor Statistics, $33.55. This mean hourly wage is adjusted by a factor of 100 percent to include fringe benefits. See https://www.bls.gov/oes/current/ oes291141.htm. 32 The adjusted hourly wage of $32.24 per hour for a Medical Secretary was obtained using the mean hourly wage from the U.S. Bureau of Labor Statistics, $16.12. This mean hourly wage is adjusted by a factor of 100 percent to include fringe benefits. See https://www.bls.gov/oes/current/ oes436013.htm. C. Submission of PRA-Related Comments mstockstill on DSK3G9T082PROD with PROPOSALS2 Total annual burden (hours) Burden per response (hours) Regulation section(s) VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 A. Regulatory Impact Analysis 1. Introduction We have examined the impacts of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96–354), section 1102(b) of E:\FR\FM\28APP2.SGM 28APP2 25536 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules mstockstill on DSK3G9T082PROD with PROPOSALS2 the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA, March 22, 1995; Pub. L. 104–4), and the Congressional Review Act (5 U.S.C. 804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This proposed rule has been designated as economically significant under section 3(f)(1) of Executive Order 12866 and thus a major rule under the Congressional Review Act. Accordingly, we have prepared a regulatory impact analysis (RIA) that, to the best of our ability, presents the costs and benefits of the rulemaking. This proposed rule was also reviewed by OMB. 2. Statement of Need This proposed rule meets the requirements of our regulations at § 418.306(c), which requires annual issuance, in the Federal Register, of the hospice wage index based on the most current available CMS hospital wage data, including any changes to the definitions of Core-Based Statistical Areas (CBSAs), or previously used Metropolitan Statistical Areas (MSAs). This proposed rule would also update payment rates for each of the categories of hospice care described in § 418.302(b) for FY 2017 as required under section 1814(i)(1)(C)(ii)(VII) of the Act. The payment rate updates are subject to changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. In addition, the payment rate updates may be reduced by an additional 0.3 percentage point (although for FY 2014 to FY 2019, the potential 0.3 percentage point reduction is subject to suspension under conditions specified in section 1814(i)(1)(C)(v) of the Act). In 2010, the Congress amended section 1814(i)(6) of VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 the Act with section 3132(a) of the Affordable Care Act. The amendment authorized the Secretary to revise the methodology for determining the payment rates for routine home care and other services included in hospice care, no earlier than October 1, 2013. In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47164), we finalized the creation of two different payment rates for RHC that resulted in a higher base payment rate for the first 60 days of hospice care and a reduced base payment rate for days 61 and over of hospice and created a SIA payment, in addition to the per diem rate for the RHC level of care, equal to the CHC hourly payment rate multiplied by the amount of direct patient care provided by an RN or social worker that occurs during the last 7 days of a beneficiary’s life, if certain criteria are met. Finally, section 3004 of the Affordable Care Act amended the Act to authorize a quality reporting program for hospices and this rule discusses changes in the requirements for the hospice quality reporting program in accordance with section 1814(i)(5) of the Act. 3. Overall Impacts We estimate that the aggregate impact of this proposed rule would be an increase of $330 million in payments to hospices, resulting from the hospice payment update percentage of 2.0 percent. The impact analysis of this proposed rule represents the projected effects of the changes in hospice payments from FY 2016 to FY 2017. Using the most recent data available at the time of rulemaking, in this case FY 2015 hospice claims data, we apply the current FY 2016 wage index and laborrelated share values to the level of care per diem payments and SIA payments for each day of hospice care to simulate FY 2016 payments. Then, using the same FY 2015 data, we apply the proposed FY 2017 wage index and labor-related share values to simulate FY 2017 payments. Certain events may limit the scope or accuracy of our impact analysis, because such an analysis is susceptible to forecasting errors due to other changes in the forecasted impact time period. The nature of the Medicare program is such that the changes may interact, and the complexity of the interaction of these changes could make it difficult to PO 00000 Frm 00040 Fmt 4701 Sfmt 4702 predict accurately the full scope of the impact upon hospices. 4. Detailed Economic Analysis The FY 2017 hospice payment impacts appear in Table 19. We tabulate the resulting payments according to the classifications in Table 19 (for example, facility type, geographic region, facility ownership), and compare the difference between current and proposed payments to determine the overall impact. The first column shows the breakdown of all hospices by urban or rural status, census region, hospitalbased or freestanding status, size, and type of ownership, and hospice base. The second column shows the number of hospices in each of the categories in the first column. The third column shows the effect of the annual update to the wage index. This represents the effect of using the proposed FY 2017 hospice wage index. The aggregate impact of this change is zero percent, due to the proposed hospice wage index standardization factor. However, there are distributional effects of the proposed FY 2017 hospice wage index. The fourth column shows the effect of the proposed hospice payment update percentage for FY 2017. The proposed 2.0 percent hospice payment update percentage for FY 2017 is based on an estimated 2.8 percent inpatient hospital market basket update, reduced by a 0.5 percentage point productivity adjustment and by a 0.3 percentage point adjustment mandated by the Affordable Care Act, and is constant for all providers. The fifth column shows the effect of all the proposed changes on FY 2017 hospice payments. It is projected that aggregate payments will increase by 2.0 percent, assuming hospices do not change their service and billing practices in response. As illustrated in Table 19, the combined effects of all the proposals vary by specific types of providers and by location. For example, due to the changes proposed in this rule, the estimated impacts on FY 2017 payments range from a 1.0 percent increase for hospices providing care in the rural West North Central region to a 2.7 percent increase for hospices providing care in the rural Pacific region. E:\FR\FM\28APP2.SGM 28APP2 25537 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules TABLE 19—PROJECTED IMPACT TO HOSPICES FOR FY 2017 Number of providers Updated wage data (%) Proposed hospice payment update (%) FY 2017 total change (%) (2) (3) (4) (5) (1) All Hospices ..................................................................................................... Urban Hospices ............................................................................................... Rural Hospices ................................................................................................ Urban Hospices—New England ...................................................................... Urban Hospices—Middle Atlantic .................................................................... Urban Hospices—South Atlantic ..................................................................... Urban Hospices—East North Central .............................................................. Urban Hospices—East South Central ............................................................. Urban Hospices—West North Central ............................................................. Urban Hospices—West South Central ............................................................ Urban Hospices—Mountain ............................................................................. Urban Hospices—Pacific ................................................................................. Urban Hospices—Outlying .............................................................................. Rural Hospices—New England ....................................................................... Rural Hospices—Middle Atlantic ..................................................................... Rural Hospices—South Atlantic ....................................................................... Rural Hospices—East North Central ............................................................... Rural Hospices—East South Central .............................................................. Rural Hospices—West North Central .............................................................. Rural Hospices—West South Central ............................................................. Rural Hospices—Mountain .............................................................................. Rural Hospices—Pacific .................................................................................. Rural Hospices—Outlying ................................................................................ 0—3,499 RHC Days (Small) ............................................................................ 3,500–19,999 RHC Days (Medium) ................................................................ 20,000+ RHC Days (Large) ............................................................................. Non-Profit Ownership ...................................................................................... For Profit Ownership ........................................................................................ Govt Ownership ............................................................................................... Other Ownership .............................................................................................. Freestanding Facility Type .............................................................................. HHA/Facility-Based Facility Type .................................................................... 4,142 3,151 991 137 252 419 396 160 218 610 312 608 39 23 41 136 139 129 184 183 106 47 3 887 2,000 1,255 1,069 2,523 159 391 3,151 991 0.0 0.0 ¥0.1 0.4 0.2 ¥0.1 ¥0.1 ¥0.1 ¥0.5 ¥0.2 ¥0.3 0.6 ¥0.7 ¥0.4 ¥0.2 0.2 0.1 ¥0.1 ¥1.0 ¥0.2 ¥0.2 0.7 ¥0.1 0.0 0.0 0.0 0.1 ¥0.1 0.5 ¥0.1 0.0 0.1 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 1.9 2.4 2.2 1.9 1.9 1.9 1.5 1.8 1.7 2.6 1.3 1.6 1.8 2.2 2.1 1.9 1.0 1.8 1.8 2.7 1.9 2.0 2.0 2.0 2.1 1.9 2.5 1.9 2.0 2.1 mstockstill on DSK3G9T082PROD with PROPOSALS2 Source: FY 2015 hospice claims data from the Standard Analytic Files for CY 2014 (as of June 30, 2015) and CY 2015 (as of December 31, 2015). Region Key: New England= Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont; Middle Atlantic = Pennsylvania, New Jersey, New York; South Atlantic = Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia; East North Central = Illinois, Indiana, Michigan, Ohio, Wisconsin; East South Central = Alabama, Kentucky, Mississippi, Tennessee; West North Central = Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota; West South Central = Arkansas, Louisiana, Oklahoma, Texas; Mountain = Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming; Pacific = Alaska, California, Hawaii, Oregon, Washington; Outlying = Guam, Puerto Rico, Virgin Islands. 5. Alternatives Considered Since the hospice payment update percentage is determined based on statutory requirements, we did not consider not updating hospice payment rates by the payment update percentage. The proposed 2.0 percent hospice payment update percentage for FY 2017 is based on a proposed 2.8 percent inpatient hospital market basket update for FY 2017, reduced by a 0.5 percentage point productivity adjustment and by an additional 0.3 percentage point. Payment rates since FY 2002 have been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent years must be the market basket percentage for that FY. Section 3401(g) of the Affordable Care Act also mandates that, starting VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 with FY 2013 (and in subsequent years), the hospice payment update percentage will be annually reduced by changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. In addition, section 3401(g) of the Affordable Care Act mandates that in FY 2013 through FY 2019, the hospice payment update percentage will be reduced by an additional 0.3 percentage point (although for FY 2014 to FY 2019, the potential 0.3 percentage point reduction is subject to suspension under conditions specified in section 1814(i)(1)(C)(v) of the Act). We considered not proposing a hospice wage index standardization factor. However, as discussed in section III.C.1 of this proposed rule, we believe that adopting a hospice wage index standardization factor would provide a PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 safeguard to the Medicare program, as well as to hospices, because it will mitigate changes in overall hospice expenditures due to annual fluctuations in the hospital wage data from year-toyear by ensuring that hospice wage index updates and revisions are implemented in a budget neutral manner. We estimate that if the hospice wage index standardization factor is not finalized, total payments in a given year would increase or decrease by as much as 0.3 percent or $50 million. 6. Accounting Statement As required by OMB Circular A–4 (available at https://www.whitehouse. gov/omb/circulars/a004/a-4.pdf), in Table 20, we have prepared an accounting statement showing the classification of the expenditures E:\FR\FM\28APP2.SGM 28APP2 25538 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Proposed Rules entities. The great majority of hospitals and most other health care providers and suppliers are small entities by meeting the Small Business Administration (SBA) definition of a small business (in the service sector, having revenues of less than $7.5 million to $38.5 million in any 1 year), or being nonprofit organizations. For purposes of the RFA, we consider all hospices as small entities as that term is used in the RFA. HHS’s practice in interpreting the RFA is to consider TABLE 20—ACCOUNTING STATEMENT: effects economically ‘‘significant’’ only CLASSIFICATION OF ESTIMATED if they reach a threshold of 3 to 5 TRANSFERS, FROM FY 2016 TO FY percent or more of total revenue or total costs. The effect of the proposed FY 2017 2017 hospice payment update [In $millions] percentage results in an overall increase in estimated hospice payments of 2.0 Category Transfers percent, or $330 million. Therefore, the FY 2017 Hospice Wage Index and Payment Secretary has determined that this proposed rule will not create a Rate Update significant economic impact on a Annualized Monetized $330.* substantial number of small entities. Transfers. In addition, section 1102(b) of the Act From Whom to Federal Government requires us to prepare a regulatory Whom? to Medicare Hosimpact analysis if a rule may have a pices. significant impact on the operations of * The net increase of $330 million in transfer a substantial number of small rural payments is a result of the 2.0 percent hospice payment update percentage compared to hospitals. This analysis must conform to the provisions of section 604 of the payments in FY 2016. RFA. For purposes of section 1102(b) of 7. Conclusion the Act, we define a small rural hospital as a hospital that is located outside of We estimate that aggregate payments a metropolitan statistical area and has to hospices in FY 2017 would increase fewer than 100 beds. This proposed rule by $330 million, or 2.0 percent, only affects hospices. Therefore, the compared to payments in FY 2016. We Secretary has determined that this estimate that in FY 2017, hospices in urban and rural areas would experience, proposed rule would not have a significant impact on the operations of on average, a 2.0 percent and a 1.9 a substantial number of small rural percent increase, respectively, in hospitals. estimated payments compared to FY 2016. Hospices providing services in the C. Unfunded Mandates Reform Act urban Pacific and rural Pacific regions Analysis would experience the largest estimated Section 202 of the Unfunded increases in payments of 2.6 percent Mandates Reform Act of 1995 also and 2.7 percent, respectively. Hospices requires that agencies assess anticipated serving patients in rural areas in the costs and benefits before issuing any West North Central region would rule whose mandates require spending experience the lowest estimated in any 1 year of $100 million in 1995 increase of 1.0 percent in FY 2017 dollars, updated annually for inflation. payments. In 2016, that threshold is approximately B. Regulatory Flexibility Act Analysis $146 million. This proposed rule is not The RFA requires agencies to analyze anticipated to have an effect on State, options for regulatory relief of small local, or tribal governments, in the businesses if a rule has a significant aggregate, or on the private sector of impact on a substantial number of small $146 million or more. mstockstill on DSK3G9T082PROD with PROPOSALS2 associated with the provisions of this proposed rule. Table 20 provides our best estimate of the possible changes in Medicare payments under the hospice benefit as a result of the policies in this proposed rule. This estimate is based on the data for 4,067 hospices in our impact analysis file, which was constructed using FY 2015 claims available as of December 31, 2015. All expenditures are classified as transfers to hospices. VerDate Sep<11>2014 21:19 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00042 Fmt 4701 Sfmt 9990 VI. Federalism Analysis and Regulations Text Executive Order 13132, Federalism (August 4, 1999) requires an agency to provide federalism summary impact statement when it promulgates a proposed rule (and subsequent final rule) that has federalism implications and which imposes substantial direct requirement costs on State and local governments which are not required by statute. We have reviewed this proposed rule under these criteria of Executive Order 13132, and have determined that it will not impose substantial direct costs on State or local governments. List of Subjects in 42 CFR Part 418 Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, the Centers for Medicare and Medicaid Services proposes to amend 42 CFR chapter IV as set forth below: PART 418—HOSPICE CARE 1. The authority citation for part 418 continues to read as follows: ■ Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). 2. Section 418.312 is amended by adding paragraph (i) to read as follows: ■ § 418.312 Data submission requirements under the hospice quality reporting program. * * * * * (i) Retention of HQRP Measures Adopted for Previous Payment Determinations. If HQRP measures are re-endorsed by the NQF without substantive changes in specifications, CMS will implement the measure without notice and comment rulemaking. Dated: April 1, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: April 14, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services. [FR Doc. 2016–09631 Filed 4–21–16; 4:15 pm] BILLING CODE 4120–01–P E:\FR\FM\28APP2.SGM 28APP2

Agencies

[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)]
[Proposed Rules]
[Pages 25497-25538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09631]

[[Page 25497]]

Vol. 81

Thursday,

No. 82

April 28, 2016

Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Part 418

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

Federal Register / Vol. 81 , No. 82 / Thursday, April 28, 2016 /
Proposed Rules

[[Page 25498]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 418

[CMS-1652-P]
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: Proposed rule.

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SUMMARY: This proposed rule would update the hospice wage index,
payment rates, and cap amount for fiscal year (FY) 2017. In addition,
this rule proposes changes to the hospice quality reporting program,
including proposing new quality measures. The proposed rule also
solicits feedback on an enhanced data collection instrument and
describes plans to publicly display quality measures and other hospice
data beginning in the middle of 2017. Finally, this proposed rule
includes information regarding the Medicare Care Choices Model (MCCM).

DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on June 20, 2016.

ADDRESSES: In commenting, please refer to file code CMS-1652-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-1652-P, P.O. Box 8010, Baltimore, MD
21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-1652-P, Mail Stop C4-26-05, 7500
Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Debra Dean-Whittaker, (410) 786 -0848
for questions regarding the CAHPS[supreg] Hospice Survey.
Michelle Brazil, (410) 786-1648 for questions regarding the hospice
quality reporting program.
For general questions about hospice payment policy, please send
your inquiry via email to: hospicepolicy@cms.hhs.gov.

SUPPLEMENTARY INFORMATION: Wage index addenda will be available only
through the internet on the CMS Web site at: (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/.)
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.

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 Proposed Rule
A. Monitoring for Potential Impacts--Affordable Care Act Hospice
Reform
1. Hospice Payment Reform: Research and Analyses
a. Pre-Hospice Spending
b. Non-Hospice Spending
c. Live Discharge Rates
d. Skilled Visits in the Last Days of Life
2. Monitoring for Impacts of Hospice Payment Reform
B. Proposed FY 2017 Hospice Wage Index and Rates Update
1. Proposed FY 2017 Hospice Wage Index
a. Background
b. FY 2016 Implementation of New Labor Market Delineations
2. Proposed FY 2017 Hospice Payment Update Percentage
3. Proposed FY 2017 Hospice Payment Rates
4. Hospice Cap Amount for FY 2017
C. Proposed 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

[[Page 25499]]

4. Previously Adopted Quality Measures for FY 2017 and FY 2018
Payment Determination
5. Proposed Removal of Previously Adopted Measures
6. Proposed New Quality Measures for FY 2019 Payment
Determinations and Subsequent Years and Concepts Under Consideration
for Future Years
a. Background and Considerations in Developing New Quality
Measures for the HQRP
b. New Quality Measures for the FY 2019 Payment Determination
and Subsequent Years
7. Form, Manner, and Timing of Quality Data Submission
a. Background
b. Previously Finalized Policy for New Facilities to Begin
Submitting Quality Data
c. Previously Finalized Data Submission Mechanism, Collection
Timelines, and Submission Deadlines for the FY 2017 Payment
Determination
d. Previously Finalized Data Submission Timelines and
Requirements for FY 2018 Payment Determination and Subsequent Years
e. Previously Finalized HQRP Data Submission and Compliance
Thresholds for the FY 2018 Payment Determination and Subsequent
Years
f. New Data Collection and Submission Mechanisms under
Consideration for Future Years
8. HQRP Submission Exemption and Extension Requirements for the
FY 2017 Payment Determination and Subsequent Years
9. Hospice CAHPS[supreg] Participation Requirements for the 2019
APU and 2020 APU
a. Background Description of the Survey
b. Participation Requirements to Meet Quality Reporting
Requirements for the FY 2019 APU
c. Participation Requirements to Meet Quality Reporting
Requirements for the FY 2020 APU
d. Annual Payment Update
e. Hospice CAHPS[supreg] Reconsiderations and Appeals Process
10. HQRP Reconsideration and Appeals Procedures for the FY 2017
Payment Determination and Subsequent Years
11. Public Display of Quality Measures and other Hospice Data
for the HQRP
D. The Medicare Care Choices Model
IV. Collection of Information Requirements
V. Economic Analyses
VI. Federalism Analysis and Regulations Text

Acronyms

Because of the many terms to which we refer by acronym in this
proposed 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
BETOS Berenson-Eggers Types of Service
BIPA Benefits Improvement and Protection Act of 2000
BNAF Budget Neutrality Adjustment Factor
BLS Bureau of Labor Statistics
CAHPS[supreg] Consumer Assessment of Healthcare Providers and
Systems
CBSA Core-Based Statistical Area
CCN CMS Certification Number
CCW Chronic Conditions Data Warehouse
CFR Code of Federal Regulations
CHC Continuous Home Care
CHF Congestive Heart Failure
CMMI Center for Medicare & Medicaid Innovation
CMS Centers for Medicare & Medicaid Services
COPD Chronic Obstructive Pulmonary Disease
CoPs Conditions of Participation
CPI Center for Program Integrity
CPI-U Consumer Price Index-Urban Consumers
CR Change Request
CVA Cerebral Vascular Accident
CWF Common Working File
CY Calendar Year
DME Durable Medical Equipment
DRG Diagnostic Related Group
ER Emergency Room
FEHC Family Evaluation of Hospice Care
FR Federal Register
FY Fiscal Year
GAO Government Accountability Office
GIP General Inpatient Care
HCFA Healthcare Financing Administration
HHS Health and Human Services
HIPPA 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
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 for this Proposed Rule

A. Purpose

This rule proposes updates to 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 proposes 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 proposed 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

Section III.A of this proposed rule describes current trends in
hospice utilization and provider behavior, as well as our efforts for
monitoring potential impacts related to the hospice reform policies
finalized in the FY 2016 Hospice Wage Index and Payment Rate Update
final rule (80 FR 47142). In section III.B.1 of this proposed rule, we
propose to update the hospice wage index with updated wage data and to
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

[[Page 25500]]

payment update percentage of 2.0 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 proposed rule, we discuss updates to HQRP,
including the proposal of 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 proposed measures would 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
potential 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 would 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 offers 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
------------------------------------------------------------------------
Provision description Transfers
------------------------------------------------------------------------
FY 2017 Hospice Wage Index and Payment The overall economic impact
Rate Update. of this proposed rule is
estimated to be $330
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.
See also 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 team 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 must consider the
primary terminal condition, related diagnoses, current subjective and
objective medical findings, current medication and treatment orders,
and information about unrelated conditions when considering the initial
certification of the terminal illness.'' (73 FR 32176). As referenced
in our regulations at Sec. 418.22(b)(1), to be eligible for Medicare
hospice services, the patient's attending physician (if any) and the
hospice medical director must certify that the individual is
``terminally ill,'' as defined in section 1861(dd)(3)(A) of the Act and
our regulations at Sec. 418.3; that is, the individual's prognosis is
for a life expectancy of 6 months or less if the terminal illness runs
its normal course. The certification of terminal illness must include a
brief narrative explanation of the clinical findings that supports a
life expectancy of 6 months or less as part of the certification and
recertification forms, as set out at Sec. 418.22(b)(3).
While the goal of hospice care is to allow the beneficiary to
remain in his or her home environment, circumstances during the end-of-
life may necessitate short-term inpatient admission to a hospital,
skilled nursing facility (SNF), or hospice facility for treatment
necessary for pain control or acute or chronic symptom management that
cannot be managed in any other setting. These acute hospice care
services are to ensure that any new or worsening symptoms are
intensively addressed so that the beneficiary can return to his or her
home environment. Limited, short-term, intermittent, inpatient respite
services are also available to the family/caregiver of the hospice
patient to relieve the family or other caregivers. Additionally, an
individual can receive continuous home care during a period of crisis
in which an individual requires primarily continuous nursing care to
achieve palliation or management of acute medical symptoms so that the
individual can remain at home. Continuous home care may be covered on a
continuous basis for as much as 24 hours a day, and these periods must
be predominantly nursing care, in accordance with our regulations at
Sec. 418.204. A minimum of 8 hours of nursing care, or nursing and
aide care,

[[Page 25501]]

must be furnished on a particular day to qualify for the continuous
home care rate (Sec. 418.302(e)(4)).
Hospices are expected to comply with all civil rights laws,
including the provision of auxiliary aids and services to ensure
effective communication with patients and patient care representatives
with disabilities consistent with Section 504 of the Rehabilitation Act
of 1973 and the Americans with Disabilities Act, and to provide
language access for such persons who are limited in English
proficiency, consistent with Title VI of the Civil Rights Act of 1964.
Further information about these requirements may be found at https://www.hhs.gov/ocr/civilrights.

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 entitled ``Medicare Program; Hospice Care'' (48 FR
38146), ``the hospice experience in the United States has placed
emphasis on home care. It offers physician services, specialized
nursing services, and other forms of care in the home to enable the
terminally ill individual to remain at home in the company of family
and friends as long as possible.'' The concept of a beneficiary
``electing'' the hospice benefit and being certified as terminally ill
were two key components of the legislation responsible for the creation
of the Medicare Hospice Benefit (section 122 of the Tax Equity and
Fiscal Responsibility Act of 1982 (TEFRA), (Pub. L. 97-248)). Section
122 of TEFRA created the Medicare Hospice benefit, which was
implemented on November 1, 1983. Under sections 1812(d) and 1861(dd) of
the Act, we provide coverage of hospice care for terminally ill
Medicare beneficiaries who elect to receive care from a Medicare-
certified hospice. Our regulations at Sec. 418.54(c) stipulate that
the comprehensive hospice assessment must identify the beneficiary's
physical, psychosocial, emotional, and spiritual needs related to the
terminal illness and related conditions, and address those needs in
order to promote the beneficiary's well-being, comfort, and dignity
throughout the dying process. The comprehensive assessment must take
into consideration the following factors: the nature and condition
causing admission (including the presence or lack of objective data and
subjective complaints); complications and risk factors that affect care
planning; functional status; imminence of death; and severity of
symptoms (Sec. 418.54(c)). The Medicare hospice benefit requires the
hospice to cover all reasonable and necessary palliative care related
to the terminal prognosis, as described in the beneficiary's plan of
care. The December 16, 1983 Hospice final rule (48 FR 56008) requires
hospices to cover care for interventions to manage pain and symptoms.
Additionally, the hospice Conditions of Participation (CoPs) at Sec.
418.56(c) require that the hospice must provide all reasonable and
necessary services for the palliation and management of the terminal
illness, related conditions, and interventions to manage pain and
symptoms. Therapy and interventions must be assessed and managed in
terms of providing palliation and comfort without undue symptom burden
for the hospice patient or family.\2\ In the December 16, 1983 Hospice
final rule (48 FR 56010), regarding what is related versus 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

[[Page 25502]]

an interdisciplinary group (described in section 1861(dd)(2)(B) of the
Act). The services offered under the Medicare hospice benefit must be
available to beneficiaries as needed, 24 hours a day, 7 days a week
(section 1861(dd)(2)(A)(i) of the Act). Upon the implementation of the
hospice benefit, the Congress 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, the 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 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 fiscal year 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

[[Page 25503]]

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, the Congress
included an aggregate cap on hospice payments, which limits the total
aggregate payments any individual hospice can receive in a year. The
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, within certain limits. We allowed existing hospices the
option of having their cap calculated via the original streamlined
methodology, also within certain limits. As of FY 2012, new hospices
have their cap determinations calculated using the patient-by-patient
proportional methodology. The patient-by-patient proportional
methodology and the streamlined methodology are two different
methodologies for counting beneficiaries when calculating the hospice
aggregate cap. A detailed explanation of these methods is found in the
August 4, 2011 FY 2012 Hospice Wage Index final rule (76 FR 47308
through 47314). If a hospice's total Medicare reimbursement for the cap
year exceeds the hospice aggregate cap, then the hospice must repay the
excess back to Medicare.
7. FY 2015 Hospice Wage Index and Payment Rate Update Final Rule
When electing hospice, a beneficiary waives Medicare coverage for
any care for the terminal illness and related conditions except for
services provided by the designated hospice and attending physician.
The FY 2015 Hospice Wage Index and Payment Rate Update final rule (79
FR 50452) finalized a requirement that requires the Notice of Election
(NOE) be filed within 5 calendar days after the effective date of
hospice election. If the NOE is filed beyond this 5 day period, hospice
providers are liable for the services furnished during the days from
the effective date of hospice election to the date of NOE filing (79 FR
50474). Similar to the NOE, the claims processing system must be
notified of a beneficiary's discharge from hospice or hospice benefit
revocation. This update to the beneficiary's status allows claims from
non-hospice providers to be processed and paid. Late filing of the NOE
can result in inaccurate benefit period data and leaves Medicare
vulnerable to paying non-hospice claims related to the terminal illness
and related conditions and beneficiaries possibly liable for any cost-
sharing associated costs. Upon live discharge or revocation, the
beneficiary immediately resumes the Medicare coverage that had been
waived when he or she elected hospice. The FY 2015 Hospice Wage Index
and Payment Rate Update final rule also finalized a requirement that
requires hospices to file a notice of termination/revocation within 5
calendar days of a beneficiary's live discharge or revocation, unless
the hospices have already filed a final claim. This requirement helps
to protect beneficiaries from delays in accessing needed care (Sec.
418.26(e)).
A hospice ``attending physician'' is described by the statutory and
regulatory definitions as a medical doctor, osteopath, or nurse
practitioner whom the beneficiary identifies, at the time of hospice
election, as having the most significant role in the determination and
delivery of his or her medical care. We received reports of problems
with the identification of the person's designated attending physician
and a third of hospice patients had multiple providers submit Part B
claims as the ``attending physician,'' using a claim modifier. The FY
2015 Hospice Wage Index and Payment Rate Update final rule finalized a
requirement that the election form include the beneficiary's choice of
attending physician and that the beneficiary provide the hospice with a
signed document when he or she chooses to change attending physicians
(79 FR 50479).
Hospice providers are required to begin using a Hospice Experience
of

[[Page 25504]]

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 fiscal year 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.

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. 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.
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 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 (see Table 2).

Table 2--The Top Twenty Principal Hospice Diagnoses, FY 2002, FY 2007,
FY 2013, FY 2015
------------------------------------------------------------------------
ICD-9/reported
Rank principal diagnosis Count Percentage
------------------------------------------------------------------------
Year: FY 2002
------------------------------------------------------------------------
1................ 162.9 Lung Cancer.... 73,769 11
2................ 428.0 Congestive 45,951 7
Heart Failure.
3................ 799.3 Debility 36,999 6
Unspecified.

[[Page 25505]]

4................ 496 COPD............. 35,197 5
5................ 331.0 Alzheimer's 28,787 4
Disease.
6................ 436 CVA/Stroke....... 26,897 4
7................ 185 Prostate Cancer.. 20,262 3
8................ 783.7 Adult Failure 18,304 3
To Thrive.
9................ 174.9 Breast Cancer.. 17,812 3
10............... 290.0 Senile 16,999 3
Dementia, Uncomp.
11............... 153.0 Colon Cancer... 16,379 2
12............... 157.9 Pancreatic 15,427 2
Cancer.
13............... 294.8 Organic Brain 10,394 2
Synd Nec.
14............... 429.9 Heart Disease 10,332 2
Unspecified.
15............... 154.0 Rectosigmoid 8,956 1
Colon Cancer.
16............... 332.0 Parkinson's 8,865 1
Disease.
17............... 586 Renal Failure 8,764 1
Unspecified.
18............... 585 Chronic Renal 8,599 1
Failure (End 2005).
19............... 183.0 Ovarian Cancer. 7,432 1
20............... 188.9 Bladder Cancer. 6,916 1
------------------------------------------------------------------------
Year: FY 2007
------------------------------------------------------------------------
1................ 799.3 Debility 90,150 9
Unspecified.
2................ 162.9 Lung Cancer.... 86,954 8
3................ 428.0 Congestive 77,836 7
Heart Failure.
4................ 496 COPD............. 60,815 6
5................ 783.7 Adult Failure 58,303 6
To Thrive.
6................ 331.0 Alzheimer's 58,200 6
Disease.
7................ 290.0 Senile Dementia 37,667 4
Uncomp..
8................ 436 CVA/Stroke....... 31,800 3
9................ 429.9 Heart Disease 22,170 2
Unspecified.
10............... 185 Prostate Cancer.. 22,086 2
11............... 174.9 Breast Cancer.. 20,378 2
12............... 157.9 Pancreas 19,082 2
Unspecified.
13............... 153.9 Colon Cancer... 19,080 2
14............... 294.8 Organic Brain 17,697 2
Syndrome NEC.
15............... 332.0 Parkinson's 16,524 2
Disease.
16............... 294.10 Dementia In 15,777 2
Other Diseases w/o
Behav. Dist.
17............... 586 Renal Failure 12,188 1
Unspecified.
18............... 585.6 End Stage Renal 11,196 1
Disease.
19............... 188.9 Bladder Cancer. 8,806 1
20............... 183.0 Ovarian Cancer. 8,434 1
------------------------------------------------------------------------
Year: FY 2013
------------------------------------------------------------------------
1................ 799.3 Debility 127,415 9
Unspecified.
2................ 428.0 Congestive 96,171 7
Heart Failure.
3................ 162.9 Lung Cancer.... 91,598 6
4................ 496 COPD............. 82,184 6
5................ 331.0 Alzheimer's 79,626 6
Disease.
6................ 783.7 Adult Failure 71,122 5
to Thrive.
7................ 290.0 Senile 60,579 4
Dementia, Uncomp.
8................ 429.9 Heart Disease 36,914 3
Unspecified.
9................ 436 CVA/Stroke....... 34,459 2
10............... 294.10 Dementia In 30,963 2
Other Diseases w/o
Behavioral Dist..
11............... 332.0 Parkinson's 25,396 2
Disease.
12............... 153.9 Colon Cancer... 23,228 2
13............... 294.20 Dementia 23,224 2
Unspecified w/o
Behavioral Dist..
14............... 174.9 Breast Cancer.. 23,059 2
15............... 157.9 Pancreatic 22,341 2
Cancer.
16............... 185 Prostate Cancer.. 21,769 2
17............... 585.6 End-Stage Renal 19,309 1
Disease.
18............... 518.81 Acute 15,965 1
Respiratory Failure.
19............... 294.8 Other 14,372 1
Persistent Mental
Dis.-classified
elsewhere.
20............... 294.11 Dementia In 13,687 1
Other Diseases w/
Behavioral Dist..
------------------------------------------------------------------------
Year: FY 2015
------------------------------------------------------------------------
1................ 331.0 Alzheimer's 195,469 13
disease.
2................ 428.0 Congestive 114,240 8
heart failure,
unspecified.
3................ 162.9 Lung Cancer.... 87,661 6
4................ 496 COPD............. 80,081 5
5................ 331.2 Senile 46,610 3
degeneration of
brain.
6................ 332.0 Parkinson's 34,734 2
Disease.

[[Page 25506]]

7................ 429.9 Heart disease, 31,695 2
unspecified.
8................ 436 CVA/Stroke....... 28,985 2
9................ 437.0 Cerebral 26,765 2
atherosclerosis.
10............... 174.9 Breast Cancer.. 23,742 2
11............... 153.9 Colon Cancer... 23,677 2
12............... 185 Prostate Cancer.. 23,061 2
13............... 157.9 Pancreatic 22,906 2
Cancer.
14............... 585.6 End stage renal 22,763 2
disease.
15............... 491.21 Obstructive 21,283 1
chronic bronchitis
with (acute)
exacerbation.
16............... 518.81 Acute 19,965 1
respiratory failure.
17............... 429.2 Cardiovascular 16,843 1
disease, unspecified.
18............... 434.91 Cerebral 15,642 1
artery occlusion,
unspecified with
cerebral infarction.
19............... 414.00 Coronary 15,566 1
atherosclerosis of
unspecified type of
vessel.
20............... 188.9 Bladder Cancer. 11,517 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 preliminary FY 2015 hospice claims data from the CCW, accessed on
January 25, 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. Preliminary 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.\3\
---------------------------------------------------------------------------

\3\ FFY15 Hospice Claims from CCW; Pulled Jan 06 2016
---------------------------------------------------------------------------

F. Use of Health Information Technology

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. The Department of Health
and Human Services (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
ONC Health IT Certification Program is available at: https://www.healthit.gov/policy-researchers-implementers/2015-edition-final-rule

III. Provisions of the Proposed Rule

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

1. Hospice Payment Reform: Research and Analyses
a. Pre-Hospice Spending
In 1982, the Congress introduced hospice into the Medicare program
as an alternative to aggressive curative treatment at the end of life.
During the development of the benefit, multiple testimonies from
industry leaders and hospice families were heard, and it was
consistently reported that hospices provided high-quality,
compassionate and humane care while also offering a reduction in
Medicare costs.\4\ Additionally, a Congressional Budget Office (CBO)
study asserted that hospice care would result in sizable savings over
conventional hospital care.\5\ Those savings estimates were based on a
comparison of spending in the last 6 months of life for a cancer
patient not utilizing hospice care versus the cost of hospice care for
the 6 months preceding

[[Page 25507]]

death.\6\ Therefore, the original language for section 1814(i) of the
Act (prior to August 29, 1983) set the hospice aggregate cap amount at
40 percent of the average Medicare per capita expenditure amount for
cancer patients in the last 6 months of life. Recent analysis conducted
by MedPAC showed that hospice appears to modestly raise end-of-life
costs.\7\ While hospice reduces costs for cancer decedents on average,
hospice does not reduce costs for individuals with long hospice stays.
---------------------------------------------------------------------------

\4\ Subcommittee of Health of the Committee of Ways and Means,
House of Representatives, March 25, 1982.
\5\ Mor V. Masterson-Allen S. (1987): Hospice care systems:
Structure, process, costs and outcome. New York: Springer Publishing
Company.
\6\ Fogel, Richard. (1983): Comments on the Legislative Intent
of Medicare's Hospice Benefit (GAO/HRD-83-72).
\7\ Hogan, C. (2015): Spending in the Last Year of Life and the
Impact of Hospice on Medicare Outlays. https://www.medpac.gov/documents/contractor-reports/spending-in-the-last-year-of-life-and-the-impact-of-hospice-on-medicare-outlays-(updated-august-
2015).pdf?sfvrsn=0
---------------------------------------------------------------------------

Analysis was conducted to evaluate pre-hospice spending for
beneficiaries who used hospice and who died in FY 2014. To evaluate
pre-hospice spending, we calculated the median daily Medicare payments
for such beneficiaries for the 180 days, 90 days, and 30 days prior to
electing hospice care. We then categorized patients according to the
principal diagnosis reported on the hospice claim. The analysis
revealed that for some patients, the Medicare payments in the 180 days
prior to the hospice election were lower than Medicare payments
associated with hospice care once the benefit was elected (see Table
3). Specifically, median Medicare spending for a beneficiary with a
diagnosis of Alzheimer's disease, non-Alzheimer's dementia, or
Parkinson's in the 180 days prior to hospice admission (about 20
percent of patients) was $64.87 per day compared to the daily RHC rate
of $156.06 in FY 2014. Closer to hospice admission, the median Medicare
payments per day increase, as would be expected as the patient
approaches the end of life and patient needs intensify. However, 30
days prior to a hospice election, median Medicare spending was $96.99
for patients with Alzheimer's disease, non-Alzheimer's dementia, or
Parkinson's. In contrast, the median Medicare payments prior to hospice
election for patients with a principal hospice diagnosis of cancer were
$143.48 in the 180 days prior to hospice admission and increased to
$293.64 in the 30 days prior to hospice admission. The average length
of stay for hospice elections where the principal diagnosis was
reported as Alzheimer's disease, non-Alzheimer's Dementia, or
Parkinson's is greater than patients with other diagnoses, such as
cancer, Cerebral Vascular Accident (CVA)/stroke, chronic kidney
disease, and Chronic Obstructive Pulmonary Disease (COPD). For example,
the average lifetime length of stay for an Alzheimer's, non-Alzheimer's
Dementia, or Parkinson's patient in FY 2014 was 119 days, compared to
47 days for patients with a principal diagnosis of cancer (or in other
words, 150 percent longer).

Table 3--Median Pre-Hospice Spending Estimates and Interquartile Range Based on 180, 90, and 30 Day Look-Back Periods Prior to Initial Hospice Admission
With Estimates of Average Lifetime Length of Stay (LOS) by Primary Diagnosis at Hospice Admission, FY 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimates of Daily Non-Hospice Medicare Spending Prior to First Hospice Admission
------------------------------------------------------------------------------------------ Mean
180 Day Look-Back 90 Day Look-Back 30 Day Look-Back Lifetime
Primary Hospice Diagnosis at Admission ------------------------------------------------------------------------------------------ Total
25th 75th 25th 75th 25th 75th Hospice
Pct. Median Pct. Pct. Median Pct. Pct. Median Pct. Days
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Diagnoses....................................... $46.92 $117.77 $241.97 $55.70 $157.92 $340.24 $58.07 $268.98 $548.00 73.9
Alzheimer's, Dementia, and Parkinson's.............. 22.56 64.87 160.29 22.16 78.62 216.75 20.18 96.99 357.49 118.8
CVA/Stroke.......................................... 51.05 111.22 233.33 70.13 158.29 338.67 102.64 320.20 588.60 55.6
Cancers............................................. 62.37 143.48 268.44 77.91 188.66 364.64 80.81 293.64 576.16 47.3
Chronic Kidney Disease.............................. 87.81 203.97 389.33 117.38 273.72 524.18 174.13 435.90 796.26 29.8
Heart (CHF and Other Heart Disease)................. 57.03 130.15 251.14 72.85 177.45 357.43 84.57 308.69 572.53 78.8
Lung (COPD and Pneumonias).......................... 63.10 140.46 268.43 87.05 196.62 396.02 114.58 360.29 676.46 69.4
All Other Diagnoses................................. 44.75 115.05 245.91 54.25 158.65 357.24 59.98 285.65 590.73 78.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: All Medicare Parts A, B, and D claims for FY 2014 from the Chronic Conditions Data Warehouse (CCW) retrieved February, 2016. Note(s): Estimates
drawn from FY2014 hospice decedents who were first-time hospice admissions, ages 66+ at hospice admission, admitted since 2006, and not enrolled in
Medicare Advantage prior to admission. All payments are inflation-adjusted to September 2014 dollars using the Consumer Price Index (Medical Care; All
Urban Consumers).

In the FY 2014 Hospice Wage Index and Payment Rate Update proposed
and final rules (78 FR 27843 and 78 FR 48272, respectively), we
discussed whether a case mix system could be created in future
refinements to differentiate hospice payments according to patient
characteristics. Analyzing pre-hospice spending was undertaken as an
initial step in determining whether patients required different
resource needs prior to hospice based on the principal diagnosis
reported on the hospice claim. Table 3 indicates that hospice patients
with the longest length of stay had lower pre-hospice spending relative
to hospice patients with shorter lengths of stay. These hospice
patients tend to be those with neurological conditions, including those
with Alzheimer's disease, other related dementias, and Parkinson's
disease. Typically, these conditions are associated with longer disease
trajectories, progressive loss of functional and cognitive abilities,
and more difficult prognostication.
b. Non-hospice Spending
When a beneficiary elects the Medicare hospice benefit, he or she
waives the right to Medicare payment for services related to the
treatment of the individual's condition with respect to which a
diagnosis of terminal illness has been made, except for services
provided by the designated hospice and the attending physician. Hospice
services are to be comprehensive and inclusive and we have reiterated
since 1983 that ``virtually all'' care needed by the terminally ill
individual would be provided by hospice, given the

[[Page 25508]]

interrelatedness of body systems. We believe that it would be unusual
and exceptional to see services provided outside of hospice for those
individuals who are approaching the end of life. However, we have
conducted ongoing analysis of non-hospice spending during a hospice
election over the past several years and this analysis seems to suggest
unbundling of services that perhaps should have been provided and
covered under the Medicare hospice benefit.
We reported initial findings on CY 2012 non-hospice spending during
a hospice election in the FY 2015 Hospice Wage Index and Payment Rate
Update final rule (79 FR 50452) and FY 2013 non-hospice spending during
a hospice election in the FY 2016 Hospice Wage Index and Payment Rate
Update final rule (80 FR 47153). In this rule, we updated our analysis
of non-hospice spending during a hospice election using FY 2014 data.
Medicare payments for non-hospice Part A and Part B services received
by hospice beneficiaries during hospice election were $710.1 million in
CY 2012, $694.1 million in FY 2013, and $600.8 million in FY 2014 (See
Figure 1). Non-hospice spending has decreased each year since we began
reporting these findings: down 2.2 percent from CY 2012 to FY 2013 and
then down 13.4 percent in from FY 2013 to FY 2014--a much more
significant decline. Overall, from CY 2012 to FY 2014 non-hospice
spending during hospice election declined 15.4 percent.
[GRAPHIC] [TIFF OMITTED] TP28AP16.003

Hospice beneficiaries had $122.5 million in Parts A and B cost-
sharing for items and services that were billed to Medicare Parts A and
B for a total of $723.3 million for FY 2014.
We also examined Part D for CY 2012 and FY 2013 spending for those
beneficiaries under a hospice election and reported those findings in
our FY 2015 and FY 2016 hospice final rules, respectively. We updated
our analysis of FY 2014 Part D Prescription Drug Event data, which
shows Medicare payments for non-hospice Part D drugs received by
hospice beneficiaries during a hospice election were $334.9 million in
CY 2012, $347.1 million in FY 2013, and $291.6 million in FY 2014 (see
Figure 2).

[[Page 25509]]

[GRAPHIC] [TIFF OMITTED] TP28AP16.004

Table 4 details the various components of Part D spending for
patients receiving hospice care. The portion of the $371.7 million
total Part D spending that was paid by Medicare is the sum of the Low
Income Cost-Sharing Subsidy and the Covered Drug Plan Paid Amount, or
$291.6 million.

Table 4--Drug Cost Sources for Hospice Beneficiaries' FY 2014 Drugs
Received Through Part D
------------------------------------------------------------------------
FY 2014
Component expenditures
------------------------------------------------------------------------
Patient Pay Amount........................................ $41,722,567
Low Income Cost-Sharing Subsidy........................... 95,389,484
Other True Out-of Pocket Amount........................... 1,704,601
Patient Liability Reduction due to Other Payer Amount..... 12,816,746
Covered Drug Plan Paid Amount............................. 196,242,194
Non-Covered Plan Paid Amount.............................. 18,428,208
Six Payment Amount Totals................................. 366,303,799
Unknown/Unreconciled...................................... 5,374,873
Gross Total Drug Costs, Reported.......................... 371,678,672
------------------------------------------------------------------------
Source: Analysis of 100% FY 2014 Medicare Claim Files. For more
information on the components above and on Part D data, go to the
Research Data Assistance Center's (ResDAC's) Web site at: https://www.resdac.org/.

We further analyzed Part D drug expenditures by the top twenty most
frequently reported principal diagnoses on hospice claims for
beneficiaries under a hospice election. These Part D expenditures
included those for common palliative drugs, which include analgesics
(anti-inflammatory, non-narcotic, and opioids), antianxiety agents,
antiemetics, and laxatives. The analysis also includes other drugs
typically associated with the conditions reported. Table 5 details Part
D spending for hospice beneficiaries by the top twenty most frequently
reported principal diagnoses on hospice claims. Overlapping hospice
claims are defined as claims for any Part D drugs that were dispensed
on a day that the beneficiary also received hospice care.

[[Page 25510]]

Table 5--Summary of Overlapping Part D Drugs by Top 20 Most Frequently Reported Hospice Principal Diagnoses in FY 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
Terminal condition Number of
------------------------------------------------------ Drug therapeutic Number of Hospice overlapping Number of Part D
classification hospice beneficiaries hospice Part D Rx gross drug
3D-DGN Description beneficiaries (%) claims payment ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
331.................... Cerebral Degenerations...... ............................ 167,677 12.6 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 50,537 61,310 1,880,621
Psychotherapeutic and ............. ............. 48,764 72,774 11,563,443
Neurological Agents--Misc.
Antipsychotics/Antimanic ............. ............. 35,307 46,857 3,229,221
Agents.
428.................... Heart Failure............... ............................ 132,174 9.9 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 38,110 46,448 1,589,113
Cardiovascular Agents--Misc. ............. ............. 509 602 1,243,362
Antihypertensives........... ............. ............. 24,889 29,843 783,221
Antianginal Agents.......... ............. ............. 11,118 13,085 688,201
Diuretics................... ............. ............. 38,081 50,186 485,243
Beta Blockers............... ............. ............. 29,545 32,833 480,877
Vasopressors................ ............. ............. 775 857 71,657
162.................... Lung Cancer................. ............................ 100,984 7.6 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 20,689 25,723 1,182,222
Antineoplastics and ............. ............. 2,042 2,217 2,093,837
Adjunctive Therapies.
294.................... Mental Disorder (Chronic)... ............................ 81,364 6.1 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 26,355 32,457 971,792
Psychotherapeutic and ............. ............. 21,181 31,800 4,868,784
Neurological Agents--Misc.
Antipsychotics/Antimanic ............. ............. 18,076 24,244 1,826,575
Agents.
496.................... COPD........................ ............................ 79,267 6.0 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 33,098 42,194 1,941,201
Antiasthmatic and ............. ............. 30,968 47,903 8,768,675
Bronchodilator Agents.
Respiratory Agents--Misc.... ............. ............. 41 47 289,214
Corticosteroids............. ............. ............. 11,600 13,516 195,780
290.................... Mental Disorder (Senile & ............................ 70,852 5.3 ........... ........... ...........
Presenile).
Common Palliative Drugs..... ............. ............. 24,206 29,992 877,181
Psychotherapeutic and ............. ............. 19,923 29,954 4,527,689
Neurological Agents--Misc.
Antipsychotics/Antimanic ............. ............. 16,323 21,700 1,555,710
Agents.
429.................... Other Heart Diseases........ ............................ 51,616 3.9 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 16,072 19,902 735,511
Antihyperlipidemics......... ............. ............. 14,071 16,122 657,115
Antihypertensives........... ............. ............. 11,363 13,585 394,125
Cardiovascular Agents--Misc. ............. ............. 152 167 379,608
Antianginal Agents.......... ............. ............. 4,821 5,778 378,205
Beta Blockers............... ............. ............. 11,955 13,190 203,521
Diuretics................... ............. ............. 12,378 15,606 152,209
Calcium Channel Blockers.... ............. ............. 5,880 6,462 115,265
Vasopressors................ ............. ............. 374 420 29,475
436.................... Stroke(Acute)............... ............................ 33,766 2.5 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 7,349 8,871 270,278
Antihypertensives........... ............. ............. 7,397 9,257 245,294
Antihyperlipidemics......... ............. ............. 6,776 8,019 239,749
Anticoagulants.............. ............. ............. 1,948 3,318 236,426
Hematological Agents--Misc.. ............. ............. 3,602 4,006 216,792
Beta Blockers............... ............. ............. 7,044 7,988 103,034
Calcium Channel Blockers.... ............. ............. 4,698 5,467 72,363
Cardiotonics................ ............. ............. 1,198 1,336 36,175
Diuretics................... ............. ............. 4,149 5,119 34,962
Cardiovascular Agents--Misc. ............. ............. 22 24 24,149
Vasopressors................ ............. ............. 90 94 7,624
332.................... Parkinson's disease......... ............................ 30,906 2.3 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 10,305 12,639 388,887
Antiparkinson Agents........ ............. ............. 15,969 22,317 2,470,058
Psychotherapeutic and ............. ............. 10,059 14,280 2,331,283
Neurological Agents--Misc.
Antipsychotics/Antimanic ............. ............. 6,581 8,859 809,845
Agents.
585.................... Chronic Renal Failure....... ............................ 27,945 2.1 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 4,888 6,026 191,297
Hematological Agents--Misc.. ............. ............. 1,204 1,350 57,443
Diuretics................... ............. ............. 3,292 4,266 44,415
Nutrients................... ............. ............. 92 138 21,096
Minerals & Electrolytes..... ............. ............. 775 921 17,458
Vitamins.................... ............. ............. 22 22 123
438.................... Stroke(Late Effect)......... ............................ 27,443 2.1 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 7,178 8,974 275,151
Antihypertensives........... ............. ............. 6,813 8,557 233,267
Anticoagulants.............. ............. ............. 1,827 3,281 200,116
Antihyperlipidemics......... ............. ............. 5,310 6,159 195,822

[[Page 25511]]

Hematological Agents--Misc.. ............. ............. 2,989 3,311 184,818
Beta Blockers............... ............. ............. 7,192 8,170 109,777
Calcium Channel Blockers.... ............. ............. 4,635 5,427 75,992
Diuretics................... ............. ............. 3,826 4,991 36,531
Cardiovascular Agents--Misc. ............. ............. 22 29 23,212
157.................... Pancreatic Cancer........... ............................ 26,858 2.0 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 4,809 5,854 302,932
Digestive Aids.............. ............. ............. 554 610 269,356
Antineoplastics and ............. ............. 367 403 146,428
Adjunctive Therapies.
518.................... Lung Diseases............... ............................ 26,683 2.0 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 3,045 3,719 129,314
Antiasthmatic and ............. ............. 1,704 2,515 396,030
Bronchodilator Agents.
Corticosteroids............. ............. ............. 754 854 11,081
414.................... Ischemic Heart Disease...... ............................ 26,673 2.0 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 8,831 10,882 425,098
Antihyperlipidemics......... ............. ............. 7,927 8,987 367,409
Antianginal Agents.......... ............. ............. 3,741 4,577 276,861
Antihypertensives........... ............. ............. 6,448 7,674 222,786
Beta Blockers............... ............. ............. 6,817 7,506 117,183
Cardiovascular Agents--Misc. ............. ............. 32 37 61,455
Calcium Channel Blockers.... ............. ............. 3,163 3,492 54,946
Cardiotonics................ ............. ............. 1,164 1,272 33,187
153.................... Colon Cancer................ ............................ 26,668 2.0 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 5,906 7,458 322,177
Antineoplastics and ............. ............. 523 574 387,221
Adjunctive Therapies.
174.................... Breast Cancer............... ............................ 25,174 1.9 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 7,080 9,151 384,738
Antineoplastics and ............. ............. 2,529 2,855 680,720
Adjunctive Therapies.
185.................... Prostate Cancer............. ............................ 22,334 1.7 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 4,446 5,655 293,249
Antineoplastics and ............. ............. 1,500 1,668 2,363,693
Adjunctive Therapies.
491.................... Chronic bronchitis.......... ............................ 18,846 1.4 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 6,469 8,157 364,686
437.................... Other Cerebrovascular ............................ 17,859 1.3 ........... ........... ...........
Disease.
Common Palliative Drugs..... ............. ............. 3,991 4,907 164,769
155.................... Liver Cancer................ ............................ 15,242 1.1 ........... ........... ...........
Common Palliative Drugs..... ............. ............. 3,317 4,174 166,550
Antineoplastics and ............. ............. 300 326 1,106,663
Adjunctive Therapies.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: CWF Claims Data, Prescription Drug TAP, Medicare Enrollment Database. Claims data through 12/18/2015. Included all beneficiaries with a paid
hospice claim (excluding hospice claims for pre-election counselling and evaluation services) for which Part D drugs were filled on a day that the
beneficiary also received hospice care.

Hospices are required to cover drugs for the palliation and
management of the terminal prognosis; we remain concerned that common
palliative and other disease-specific drugs for hospice beneficiaries
are being covered and paid for through Part D. Because hospices are
required to provide a comprehensive range of services, including drugs,
to Medicare beneficiaries under a hospice election, we believe that
Medicare could be paying twice for drugs that are already covered under
the hospice per diem payment by also paying for them under Part D.\8\
---------------------------------------------------------------------------

\8\ oig.hhs.gov/oas/region6/61000059.pdf ``Medicare Could Be
Paying Twice for Prescriptions For Beneficiaries in Hospice.''
---------------------------------------------------------------------------

Total non-hospice spending paid by either Medicare or by
beneficiaries that occurred during a hospice election was $723.3
million ($600.8 million Medicare spending plus $122.5 million in
beneficiary cost-sharing liabilities) for Parts A and B plus $371.6
million ($291.6 million Medicare spending plus $80 million in
beneficiary cost-sharing liabilities) for Part D spending, or
approximately $1.1 billion dollars total in FY 2014.
c. Live Discharge Rates
Currently, federal regulations allow a beneficiary who has elected
to receive Medicare hospice services to revoke their hospice election
at any time and for any reason. Specifically, the regulations state
that if the hospice beneficiary (or his/her representative) revokes the
hospice election, Medicare coverage of hospice care for the remainder
of that period is forfeited. The beneficiary may, at any time, re-elect
to receive hospice coverage for any other hospice election period that
he or she is eligible to receive (Sec. 418.24(e) and Sec.
418.28(c)(3)). During the time period between revocation/discharge and
the re-election of the hospice benefit, Medicare coverage would resume
for those Medicare benefits previously waived. A revocation can only be
made by the beneficiary, in writing, that he or she is revoking the
hospice election and the effective date of the revocation. A hospice
cannot ``revoke'' a beneficiary's

[[Page 25512]]

hospice election, nor is it appropriate for hospices to encourage,
request or demand that the beneficiary revoke his or her hospice
election. Like the hospice election, a hospice revocation is to be an
informed choice based on the beneficiary's goals, values and
preferences for the services they wish to receive through Medicare.
Federal regulations limit the circumstances in which a Medicare
hospice provider may discharge a patient from its care. In accordance
with Sec. 418.26, discharge from hospice care is permissible when the
patient moves out of the provider's service area, is determined to be
no longer terminally ill, or for cause. Hospices may not discharge the
patient at their discretion, even if the care may be costly or
inconvenient for the hospice program. As we indicated in the FY 2015
Hospice Wage Index and Payment Rate Update proposed and final rules, we
understand that the rate of live discharges should not be zero, given
the uncertainties of prognostication and the ability of beneficiaries
and their families to revoke the hospice election at any time. On July
1, 2012, we began collecting discharge information on the claim to
capture the reason for all types of discharges which includes, death,
revocation, transfer to another hospice, moving out of the hospice's
service area, discharge for cause, or due to the beneficiary no longer
being considered terminally ill (that is, no longer qualifying for
hospice services). Based upon the additional discharge information, Abt
Associates, our research contractor performed analysis on FY 2014
claims to identify those beneficiaries who were discharged alive. In
order to better understand the characteristics of hospices with high
live discharge rates, we examined the aggregate cap status, skilled
visit intensity; average lengths of stay; and non-hospice spending
rates per beneficiary.
While Figure 3 demonstrates an incremental decrease in average
annual rates of live discharge rates from 2006 to 2014, peaking in
2007, there has been a leveling off at around 18 percent over the past
several years.
[GRAPHIC] [TIFF OMITTED] TP28AP16.005

Among hospices with 50 or more discharges (discharged alive or
deceased), there is significant variation in the rate of live discharge
between the 10th and 90th percentiles (see Table 6). Most notably,
hospices at the 95th percentile discharged 50 percent or more of their
patients alive in FY 2014.

Table 6--Distribution of Live Discharge Rates in FY 2014 for Hospices
With 50 or More Live Discharges
------------------------------------------------------------------------
Live discharge
Statistic rate (%)
------------------------------------------------------------------------
5th Percentile.......................................... 7.4
10th Percentile......................................... 8.9
25th Percentile......................................... 12.3
Median.................................................. 17.5
75th Percentile......................................... 26.2
90th Percentile......................................... 39.1
95th Percentile......................................... 50.0
Note: n = 3,135......................................... ..............
------------------------------------------------------------------------
Source: FY 2014 claims from SSS Analytic File.

In FY 2014, we found that hospices with high live discharge rates
also, on average, provided fewer visits per week. Those hospices with
live discharge rates at or above the 90th percentile provided, on
average, 4.05 visits per week. Hospices with live discharge rates below
the 90th percentile provided, on average, 4.73 visits per week. We also
found in FY 2014 that, when focusing on visits classified as skilled
nursing or medical social services, hospices with live discharge rates
at or above the 90th percentile provided, on average, 1.88 visits per
week versus hospices with live discharge rates below the 90th
percentile that provided, on average, 2.34 visits per week.
We examined whether there was a relationship between hospices with
high live discharge rates, average lengths of stay, and non-hospice
spending per beneficiary per day (see Table 7 and Figure 2). Hospices
with patients that, on average, accounted for $27 per day in non-
hospice spending while in hospice (decile 10 in Table 7 and Figure 4)
had live discharge rates that were, on average, about 34.7 percent and
had an

[[Page 25513]]

average lifetime length of stay of 158 days. In contrast, hospices with
patients that, on average, accounted for only $3.66 per day in non-
hospice spending while in a hospice election (decile 1 in Table 7 and
Figure 4) had live discharge rates that were, on average, about 18.2
percent and had an average lifetime length of stay of 99.8 days. In
other words, hospices in the highest decile, according to their level
of non-hospice spending for patients in a hospice election, had live
discharge rates and average lifetime lengths of stay that averaged 90
percent and 58 percent higher, respectively, than the hospices in
lowest decile.

Table 7--Mean Daily Non-Hospice Medicare Utilization and Sum Total Non-
Hospice Utilization by Hospice Provider Decile Based on Sorted Non-
Hospice Medicare Utilization per Hospice Day, FY 2014
------------------------------------------------------------------------
Non-hospice
Medicare ($) per Total non-
Decile hospice service hospice
day Medicare ($)
------------------------------------------------------------------------
1................................... $3.66 $21,981,020
2................................... 5.50 39,167,526
3................................... 6.88 52,038,093
4................................... 8.11 67,119,545
5................................... 9.26 79,829,044
6................................... 10.63 99,430,439
7................................... 12.12 143,575,036
8................................... 14.03 163,323,857
9................................... 16.84 162,402,299
10.................................. 26.60 233,419,872
All Hospices........................ 11.37 1,062,286,730
------------------------------------------------------------------------
Note: Analysis of 100 percent Medicare Analytic Files, FY 2014. Cohort
is hospices with 50+ total discharges in FY 2014 [n = 3,135]. Hospice
deciles are based on estimates of total non-hospice Medicare
utilization ($) per hospice service day, excluding utilization on
hospice admission or live discharge days.

[[Page 25514]]

[GRAPHIC] [TIFF OMITTED] TP28AP16.006

The analytic findings in Table 7 and Figure 4 suggest that some
hospices may be using the Medicare Hospice program inappropriately as a
long-term care (``custodial'') benefit rather than an end of life
benefit for terminal beneficiaries. As previously discussed in reports
by MedPAC, there is a concern that hospices may be admitting
beneficiaries who do not legitimately meet hospice eligibility
criteria. Additionally, the Office of the Inspector General (OIG), has
raised concerns about the potential for hospices to target
beneficiaries who have long lengths of stay or certain diagnoses
because they may offer the hospices the greatest financial gain.\9\ We
continue to communicate and collaborate across CMS to improve
monitoring and oversight activities of hospice activities. We expect to
analyze more recent hospice claims and cost report data as they become
available to determine whether additional regulatory proposals to
reform and strengthen the Medicare hospice benefit are warranted.
---------------------------------------------------------------------------

\9\ Medicare Hospices Have Financial Incentives To Provide Care
in Assisted Living Facilities OEI-02-14-00070.
---------------------------------------------------------------------------

d. Skilled Visits in the Last Days of Life
As we noted in the FY 2016 Hospice Wage Index and Payment Rate
Update final rule (80 FR 47164), we are concerned that many
beneficiaries are not receiving skilled visits during the last few days
of life. At the end of life, patient needs typically surge and more
intensive services are warranted. However, analysis of FY 2014 claims
data shows that on any given day during the last 7 days of a hospice
election, nearly 47 percent of the time the patient has not received a
skilled visit (skilled nursing or social worker visit) (see Table 8).
Moreover, on the day of death nearly 26 percent of beneficiaries did
not receive a skilled visit (skilled nursing or social work visit).
While Table 8 shows the frequency and length of skilled nursing and
social work visits combined during the last 7 days of a hospice
election in FY 2014, Tables 9 and 10 show the frequency and length of
visits for skilled nursing and social work separately. Analysis of FY
2014 claims data shows that on any given day during the last 7 days of
a hospice election, almost 49 percent of the time the patient had not
received a visit by a skilled nurse, and 91 percent of the time the
patient had not received a visit by a

[[Page 25515]]

social worker (see Tables 9 and 10, respectively). We believe it is
important to assure that beneficiaries and their families and
caregivers are, in fact, receiving the level of care necessary during
critical periods such as the very end of life.

Table 8--Frequency and Length of Skilled Nursing and Social Work Visits (Combined) During the Last Seven Days of a Hospice Election, FY 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
Last seven
Day of One day Two days Three days Four days Five days Six days days
Visit length death before before before before before before combined
death (%) death (%) death (%) death (%) death (%) death (%) (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
No visit........................................ 25.8 39.0 45.7 50.2 53.5 56.2 58.5 46.3
15 mins to 1 hr................................. 24.6 28.5 26.6 25.4 24.3 23.5 22.7 25.1
1 hr 15 m to 2 hrs.............................. 24.9 19.1 17.1 15.6 14.4 13.4 12.6 16.9
2 hrs 15 m to 3 hrs............................. 12.7 7.0 5.7 4.9 4.4 4.1 3.5 6.3
3 hrs 15 m to 3 hrs 45m......................... 4.4 2.3 1.8 1.6 1.3 1.2 1.1 2.0
4 or more hrs................................... 7.6 4.2 3.0 2.4 2.1 1.8 1.6 3.4
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................................... 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: FY 2014 hospice claims data from the Standard Analytic Files for CY 2013 (as of June 30, 2014) and CY 2014 (as of December 31, 2015).

Table 9--Frequency and Length of Skilled Nursing Visits During the Last Seven Days of a Hospice Election, FY 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
Last seven
Day of One day Two days Three days Four days Five days Six days days
Visit length death before before before before before before combined
death (%) death (%) death (%) death (%) death (%) death (%) (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
No visit........................................ 27.2 41.6 48.6 53.1 56.5 59.2 61.5 48.9
15 mins to 1 hr................................. 25.1 29.5 27.1 25.5 24.3 23.3 22.3 25.5
1 hr 15 m to 2 hrs.............................. 25.2 18.6 16.5 14.8 13.6 12.6 11.8 16.4
2 hrs 15 m to 3 hrs............................. 12.3 5.5 4.4 3.7 3.3 2.9 2.6 5.2
3 hrs 15 m to 3 hrs 45m......................... 4.0 1.7 1.3 1.0 0.8 0.8 0.8 1.6
4 or more hrs................................... 6.3 3.2 2.2 1.8 1.5 1.3 1.2 2.6
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................................... 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: FY 2014 hospice claims data from the Standard Analytic Files for CY 2013 (as of June 30, 2014) and CY 2014 (as of December 31, 2015).

Table 10--Frequency and Length of Social Work Visits During the Last Seven Days of a Hospice Election, FY 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
Last seven
Day of One day Two days Three days Four days Five days Six days days
Visit length death before before before before before before combined
death (%) death (%) death (%) death (%) death (%) death (%) (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
No visit........................................ 91.6 89.1 90.2 90.9 91.5 91.9 92.3 91.0
15 mins to 1 hr................................. 4.9 7.1 6.4 6.1 5.7 5.5 5.2 5.8
1 hr 15 m to 2 hrs.............................. 2.5 3.1 2.8 2.6 2.4 2.2 2.1 2.6
2 hrs 15 m to 3 hrs............................. 0.6 0.6 0.4 0.3 0.2 0.2 0.2 0.4
3 hrs 15 m to 3 hrs 45m......................... 0.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0
4 or more hrs................................... 0.2 0.1 0.1 0.0 0.0 0.0 0.0 0.1
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................................... 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: FY 2014 hospice claims data from the Standard Analytic Files for CY 2013 (as of June 30, 2014) and CY 2014 (as of December 31, 2015).

A recent article published in the Journal of American Medicine
(JAMA) titled ``Examining Variation in Hospice Visits by Professional
Staff in the Last 2 Days of Life'' also highlighted concerns regarding
the lack of visits by professional hospice staff (defined as nursing
staff (RN and LPN), social workers, nurse practitioners, or physicians)
in the last days of a hospice episode. This study found that, of the
661,557 Medicare hospice beneficiaries who died in FY 2014, 81,478
(12.3 percent) received no professional staff visits in the last 2 days
of life. Furthermore, professional staff from 281 hospice programs,
with at least 30 discharges during federal fiscal year 2014, did not
visit any of their patients who were entitled to have received such RHC
services during the last 2 days of life. Additionally, the
investigation demonstrated that black patients and frail, older adults
residing in nursing homes and enrolled in Medicare hospice often did
not receive visits from hospice staff in the last 2 days of life,
raising concerns over disparities of care. The authors believe that
further research is needed in order to understand

[[Page 25516]]

whether a lack of visits by professional staff affects the quality of
care for the dying person and their family.\10\ 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 a myriad of physical and emotional symptoms,
necessitating close care and attention from the integrated hospice
team. 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. This is discussed further in section III.C.6, Proposed Updates
to the Hospice Quality Reporting Program, where a new hospice quality
reporting measure is proposed, ``Hospice Visits when Death is
Imminent''. We believe that the implementation of the Service Intensity
Add-on (SIA) payment, finalized in the FY 2016 Hospice Wage Index and
Payment Rate Update final rule (80 FR 47164 through 47177), represents
an incremental step toward encouraging higher frequency of much-needed
end of life care by encouraging visits during beneficiaries' most
intensive time of need for skilled care--the last 7 days of life.
---------------------------------------------------------------------------

\10\ Teno, J., Plotzke, M., Christian, T. & Gozalo, P. (2016).
Examining Variation in Hospice Visits by Professional Staff in the
Last 2 Days of Life. Journal of American Medicine Internal Medicine.
Published online February 8, 2016. doi:10.1001/
jamainternmed.2015.7479.
---------------------------------------------------------------------------

2. Monitoring for Impacts of Hospice Payment Reform
As noted above, in the FY 2016 Hospice Wage Index and Payment Rate
Update final rule (80 FR 47142), we finalized the creation of two RHC
rates--one RHC rate for the first 60 days of hospice care and a second
RHC rate for days 61 and beyond. As noted in section III.A.1.d, in the
same final rule, we also created a SIA payment. The SIA payment is paid
in addition to the RHC per diem payment for direct care provided by a
RN or social worker in the last 7 days of life. The two RHC rates and
the SIA payment became effective on January 1, 2016. The goal of these
hospice payment reform changes is to more accurately align hospice
payment with resource utilization while encouraging appropriate, high-
quality hospice care, and maximizing beneficiary, family, and caregiver
satisfaction with care. As noted in the FY 2016 final rule, as data
become available, we will monitor the impact of the hospice payment
reform changes finalized in the rule as well as continue to monitor
general hospice trends to help inform future policy efforts and program
integrity measures. This monitoring and analysis will include, but not
be limited to, monitoring hospice diagnosis reporting, lengths of stay,
live discharge patterns and their relationship with the provision of
services and the aggregate cap, non-hospice spending for Parts A, B and
D during a hospice election, trends of live discharge at or around day
61 of hospice care, and readmissions after a 60 day lapse since live
discharge.
Specifically, we will work with our monitoring contractor, Acumen
LLC, to conduct comprehensive, real time monitoring and analysis of
hospice claims to help identify program vulnerabilities, as well as
potential areas of fraud and abuse. To monitor overall usage and
payment trends in hospice, Acumen will track monthly and annual changes
in the following metrics.

1. Percentage of Medicare beneficiaries electing hospice
2. Total number of Medicare hospice patients
3. Demographic and geographic location characteristics among Medicare
hospice patients
4. Number and share of Medicare hospice patients presenting with
various terminal conditions, aggregated by broader clinical categories
5. Total payment for hospice care (also by level of care)
6. Number and share of live discharges
7. Number and rate of readmissions
8. Average length of episodes
9. Proportion of days by level of care (RHC, CHC, general inpatient
care (GIP), and inpatient respite care (IRC))
10. Volume and payments for non-hospice services used during hospice
stays

Additionally, to address policy impacts, specifically for the hospice
payment reform provisions finalized in the FY 2016 Hospice Wage Index
and Payment Rate Update final rule, Acumen will longitudinally monitor
the effect of changes in the RHC payment rate on volume and payments
for hospice care using the following metrics:

1. Average length of hospice stays
2. Total number and share of live discharges
3. Average readmissions rates within or after 60 days

Acumen will monitor the effects of the new SIA payment policy using
the following metrics:

1. Total number of nursing visits (also separately for RNs and LPNs)
2. Total number of visits by social workers
3. Average number of services billed per discharge
4. Average number of hours billed per discharge and per hospice day
5. Average number of services billed during the first 7 days, middle of
a stay, and last 7 days of a hospice stay
6. Intensity of services billed during the first 7 days, middle of a
stay, and last 7 days of a hospice stay

These measures are further broken down by level of care (for
example, RHC versus CHC) to understand the effect of the SIA payment
policy on incentivizing care at the RHC level.
The monitoring analysis can be examined at the aggregate level as
well as at the individual provider level. This comprehensive and
provider-level monitoring will not only inform future policymaking
decisions but targeted program integrity efforts as well.
In addition to Acumen LLC's comprehensive, real time monitoring and
analysis of hospice claims, we have developed a hospice Program for
Evaluating Payment Patterns Electronic Reports (PEPPER), which
generates informational tables provided to hospices that summarize
provider-specific Medicare data statistics for target areas often
associated with Medicare improper payments due to billing, coding and/
or admission necessity issues. The intent of the hospice PEPPER is to
help inform hospices of potential program administration and other
vulnerabilities to provide the opportunity for improvement.
Specifically, these reports can be used to compare performance of a
specific hospice to that of other hospices in various geographic
delineations, including the nation, specific MAC jurisdictions, and
states. PEPPER can also be used to compare data statistics over time to
identify changes in billing practices, to pinpoint areas in need of
auditing and monitoring, identify other potential problems and to help
hospices achieve CMS' goal of reducing and preventing improper
payments. The hospice PEPPER provides various metrics, including
several markers of live discharges on various time intervals, markedly
long lengths of stay, as well as information regarding levels and
frequency of hospice care provided in various settings. Recently added
metrics include differentiating reasons for live discharges (for
example, beneficiary being no longer terminally ill, patient

[[Page 25517]]

revocations), live discharges with length of stay between 61 to179
days, claims with a single diagnosis coded, and hospice episodes of
care when no GIP or CHC is provided.

B. Proposed FY 2017 Hospice Wage Index and Rate Update

1. Proposed FY 2017 Hospice Wage Index
a. Background
The hospice wage index is used to adjust payment rates for hospice
agencies under the Medicare program to reflect local differences in
area wage levels, based on the location where services are furnished.
The hospice wage index utilizes the wage adjustment factors used by the
Secretary for purposes of section 1886(d)(3)(E) of the Act for hospital
wage adjustments. Our regulations at Sec. 418.306(c) require each
labor market to be established using the most current hospital wage
data available, including any changes made by 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 hospital pre-floor, pre-reclassified 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 https://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, 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 proposed rule, for FY 2017, we
propose to continue to use the most recent pre-floor, pre-reclassified
hospital wage index value available for Puerto Rico, which is 0.4047.
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 Combines Statistical Areas, and guidance on uses of the delineation
in these areas. A copy of this bulletin is available online at: https://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 37246-37252)
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.
The proposed wage index applicable for FY 2017 is available on the
CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/. The proposed wage index applicable for FY
2017 will not be published in the Federal Register. The proposed
hospice wage index for FY 2017 would be effective October 1, 2016
through September 30, 2017.
2. Proposed 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

[[Page 25518]]

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: https://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 proposed hospice
payment update percentage for FY 2017 is based on the estimated
inpatient hospital market basket update of 2.8 percent (based on IHS
Global Insight, Inc.'s first quarter 2016 forecast with historical data
through the fourth quarter of 2015). Due to the requirements at
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 2.8 percent must
be reduced by a MFP adjustment as mandated by Affordable Care Act
(currently estimated to be 0.5 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 proposed hospice payment update percentage for
FY 2017 is 2.0 percent. We are also proposing that if more recent data
are subsequently available (for example, a more recent estimate of the
inpatient hospital market basket update and MFP adjustment), we would
use such data, if appropriate, to determine the FY 2017 market basket
update and the MFP adjustment in the FY 2017 Hospice Rate Update final
rule.
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.
3. Proposed 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 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, if certain criteria
are met. In order to maintain budget neutrality, as required under
section 1814(i)(6)(D)(ii) of the Act, the new RHC rates were adjusted
by a SIA budget neutrality factor.
As discussed in the FY 2016 Hospice Wage Index and 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 would
apply to days 1 through 60 is calculated to be 1.0001. The budget
neutrality adjustment that would apply to days 61 and beyond is
calculated to be 0.9999.
For FY 2017, we are proposing to apply 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 would eliminate the
aggregate effect of annual variations in hospital wage data. We believe
that adopting a hospice wage index standardization factor would provide
a safeguard to the Medicare program as well as to hospices because it
would 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 would be increased by the full proposed FY 2017
hospice payment update percentage of 2.0 percent as discussed in
section III.C.3. The proposed FY 2017 RHC rates are shown in Table 11.
The proposed FY 2017 payment rates for CHC, IRC, and GIP are shown in
Table 12.

[[Page 25519]]

Table 11--Proposed FY 2017 Hospice RHC Payment Rates
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2017
Proposed wage proposed
FY 2016 index hospice FY 2017
Code Description payment rates SBNF standardization payment proposed
factor update payment rates
percentage
--------------------------------------------------------------------------------------------------------------------------------------------------------
651.................................. Routine Home Care (days 1-60).. $186.84 x 1.0001 x 0.9990 x 1.020 $190.41
651.................................. Routine Home Care (days 61+)... 146.83 x 0.9999 x 0.9995 x 1.020 149.68
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 12--Proposed FY 2017 Hospice CHC, IRC, and GIP Payment Rates
----------------------------------------------------------------------------------------------------------------
FY 2017
Proposed wage proposed
FY 2016 index hospice FY 2017
Code Description payment rates standardization payment proposed
factor update payment rates
percentage
----------------------------------------------------------------------------------------------------------------
652...................... Continuous Home $944.79 x 1.0000 x 1.020 $963.69
Care.
Full Rate = 24
hours of care
40.16 = FY 2017
hourly rate
655...................... Inpatient Respite 167.45 x 1.0000 x 1.020 170.80
Care.
656...................... General Inpatient 720.11 x 0.9996 x 1.020 734.22
Care.
----------------------------------------------------------------------------------------------------------------

Sections 1814(i)(5)(A) through (C) of the Act require that hospices
begin submitting quality data, based on measures to be specified by the
Secretary. In the FY 2012 Hospice Wage Index final rule (76 FR 47320
through 47324), we implemented a Hospice Quality Reporting Program
(HQRP) as required by section 3004 of the Affordable Care Act. Hospices
were required to begin collecting quality data in October 2012, and
submit that quality data in 2013. Section 1814(i)(5)(A)(i) of the Act
requires that beginning with FY 2014 and each subsequent FY, the
Secretary shall reduce the market basket update by 2 percentage points
for any hospice that does not comply with the quality data submission
requirements with respect to that FY. The proposed FY 2017 rates for
hospices that do not submit the required quality data would be updated
by the proposed FY 2017 hospice payment update percentage of 2.0
percent minus 2 percentage points. These rates are shown in Tables 13
and 14.

Table 13--Proposed FY 2017 Hospice RHC Payment Rates for Hospices That DO NOT Submit the Required Quality Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2017
proposed
Proposed wage hospice
FY 2016 index payment FY 2017
Code Description payment rates SBNF standardization update of 2.0% proposed
factor minus 2 payment rates
percentage
points = 0.0%
--------------------------------------------------------------------------------------------------------------------------------------------------------
651.................................. Routine Home Care (days 1-60).. $186.84 x 1.0001 x 0.9990 x 1.000 $186.67
651.................................. Routine Home Care (days 61+)... 146.83 x 0.9999 x 0.9995 x 1.000 146.74
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 14--Proposed FY 2017 Hospice CHC, IRC, and GIP Payment Rates for Hospices That DO NOT Submit the Required
Quality Data
----------------------------------------------------------------------------------------------------------------
FY 2017
proposed
Proposed wage hospice
FY 2016 index payment FY 2017
Code Description payment rates standardization update of proposed
factor 2.0% minus 2 payment rates
percentage
points = 0.0%
----------------------------------------------------------------------------------------------------------------
652...................... Continuous Home $944.79 x 1.0000 x 1.000 $944.79
Care.
Full Rate = 24
hours of care.
$39.37 = FY 2017
hourly rate.
655...................... Inpatient Respite 167.45 x 1.0000 x 1.000 167.45
Care.
656...................... General Inpatient 720.11 x 0.9996 x 1.000 719.82
Care.
----------------------------------------------------------------------------------------------------------------

[[Page 25520]]

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 fiscal year 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 $28,377.17, which is equal to the 2016 cap
amount ($27,820.75) updated by the FY 2017 hospice payment update
percentage of 2.0 percent.

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 0.0 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 a 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: https://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 (https://www.qualityforum.org/npp/), the HHS Strategic Plan (https://www.hhs.gov/secretary/about/priorities/priorities.html), the National Strategy for
Quality Improvement in Healthcare, (https://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/payers, and other stakeholders.
3. Policy for Retention of HQRP Measures Adopted for Previous Payment
Determinations
In the FY 2016 Hospice Wage Index final rule, for the purpose of
streamlining the rulemaking process, we stated 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 if:
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 was
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

[[Page 25521]]

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 propose to codify
that if measures we are using in the HQRP undergo non-substantive
changes in the specifications as part of their NQF re-endorsement
process, we would subsequently utilize the measure with their new
endorsed status in the HQRP without going through new notice-and-
comment rulemaking. 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 (https://www.qualityforum.org/About_NQF/Mission_and_Vision.aspx). The NQF
undertakes review of: (1) New quality measures and national consensus
standards for measuring and publicly reporting on performance; (2)
regular maintenance processes for endorsed quality measures; (3)
measures with time limited endorsement for consideration of full
endorsement; and (4) 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,
or 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,\11\ we believe that the NQF measure
endorsement and maintenance process itself is transparent,
scientifically rigorous, and provides opportunity for public input.
Thus, we propose to codify at Sec. 418.312 that if the NQF makes only
non-substantive changes to specifications for HQRP measures in the
NQF's re-endorsement process we would continue to utilize the measure
in its new endorsed status. If NQF-endorsed specifications change and
we do not adopt those changes, then we would propose the measure as an
application (that is, with CMS modifications). An application of a NQF-
endorsed quality measure is utilized in instances when we have
identified a need to use a NQF-endorsed measure in a QRP, but needs to
use it with one or more modifications to the quality measure's
specifications. We may modify one or more of the following aspects of a
NQF-endorsed quality measure: (1) Numerator; (2) denominator; (3)
setting; (4) look-back period; (5) calculation period; (6) risk
adjustment; and (7) revisions to data elements used to collect the data
the data required for the measure. Reasons for not adopting changes in
measure specifications may include any of the aforementioned criteria
for removal, 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 vs non-substantive
change on a measure-by-measure basis. 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.
---------------------------------------------------------------------------

\11\ ``NQF: How Endorsement Happens--National Quality Forum.''
2010. 26 Jan. 2016 https://www.qualityforum.org/Measuring_Performance/ABCs/How_Endorsement_Happens.aspx.
---------------------------------------------------------------------------

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), We 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, we 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

[[Page 25522]]

finalized the proposal to codify the HIS submission requirement at
Sec. 418.312. The System of Record (SOR) Notice titled ``Hospice Item
Set (HIS) System,'' SOR number 09-70-0548, was published in the Federal
Register on April 8, 2014 (79 FR 19341).

Table 15--Previously Finalized Quality Measures Affecting the FY 2017 Payment Determination and Subsequent Year
----------------------------------------------------------------------------------------------------------------
Data submission
Quality measure NQF ID No. Type Submission method deadlines
----------------------------------------------------------------------------------------------------------------
Treatment Preferences............ 1641 Process Measure..... Hospice Item Set.... Within 30 days of
patient admission
or discharge (Event
Date).
Beliefs/Values Addressed......... 1647
Pain Screening................... 1634
Pain Assessment.................. 1637
Dyspnea Screening................ 1639
Dyspnea Treatment................ 1638
Patients Treated with an Opioid 1617
who are Given a Bowel Regimen.
----------------------------------------------------------------------------------------------------------------

5. Proposed Removal of Previously Adopted Measures
As mentioned in section III.E.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.E.3 of this proposed rule. We are 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.E.2 of this proposed rule, our 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, we take 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, we 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.\12\ Finally,
the current HQRP measure set is also an important consideration for
future measure development areas; future measure development areas
should complement the current HQRP measure set, which includes HIS
measures and Consumer Assessment of Healthcare Providers and Systems
(CAHPS[supreg]) Hospice Survey measures.
---------------------------------------------------------------------------

\12\ 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, we 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, we have pursued measure development for 2 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 on 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: https://www.qualityforum.org/ProjectMaterials.aspx?projectID=75370. The MAP supported the direction
of each proposed measure.
b. New Quality Measures for the FY 2019 Payment Determination and
Subsequent Years
We are proposing 2 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 as follows:
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 and addresses case
management and clinical care.
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
and 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

[[Page 25523]]

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, and hospital
death, and 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 \13\ and the NCP Clinical Practice Guidelines
for Quality Palliative Care \14\ 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 \15\ 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.
---------------------------------------------------------------------------

\13\ National Quality Forum. A National Framework and Preferred
Practices for Palliative and Hospice Care Quality. 2006; Available
from: https://www.qualityforum.org/publications/2006/12/A_National_Framework_and_Preferred_Practices_for_Palliative_and_Hospice_Care_Quality.aspx.
\14\ National Consensus Project, Clinical Practice Guidelines
for Quality Palliative Care. 3rd edition. 2013, National Consensus
Project: Pittsburgh, PA.
\15\ 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.\16\ 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.
---------------------------------------------------------------------------

\16\ 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.\17\
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).
---------------------------------------------------------------------------

\17\ 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 14th and 15th,
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: https://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. We have proposed that 4 new items be added to the
HIS-Discharge record to collect the necessary data elements for this
measure. We expect that data collection for this quality measure via
the 4 new HIS items would begin no earlier than April 1, 2017. Thus,
under our current 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, we 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.E.7c through III.E.7e of this proposed rule. In those
sections, we 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.
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.

[[Page 25524]]

We invite public comment on our proposal to implement the Hospice
Visits when Death is Imminent measure pair beginning April 1, 2017, as
previously
(2) Proposed Quality Measure 2: Hospice and Palliative Care Composite
Process Measure--Comprehensive Assessment at Admission
Measure Background. The Hospice and Palliative Care Composite
Process Measure--Comprehensive Assessment at Admission is a composite
measure that assesses whether a comprehensive patient assessment is
completed at hospice admission by evaluating the number of individual
care processes completed upon admission for each hospice patient stay.
A composite measure, as defined by the NQF, is a combination of 2 or
more component measures, each of which individually reflects quality of
care, into a single performance measure with a single score.\18\ For
more information on composite measure definitions, guiding principles,
and measure evaluation criteria, we refer readers to the NQF Composite
Performance Measure Evaluation Guidance Publication available at:
https://www.qualityforum.org/Publications/2013/04/Composite_Performance_Measure_Evaluation_Guidance.aspx. A total of 7
individual care processes will be captured in this composite measure,
which include the 6 NQF-endorsed quality measures and 1 modified NQF-
endorsed quality measure currently implemented in the HQRP. Thus, the
Hospice and Palliative Care Composite Process quality measure will use
the current HQRP quality measures as its components. These individual
component measures address care processes around hospice admission that
are clinically recommended or required in the hospice CoPs.\19\ This
measure calculates the percentage of patients who received all care
processes at admission. To calculate this measure, the individual
component of the composite measure are assessed separately for each
patient and then aggregated into one score for each hospice.
---------------------------------------------------------------------------

\18\ National Quality Forum. (2013). Composite Performance
Measure Evaluation Guidance: National Quality Forum.
\19\ Medicare and Medicaid Programs: Hospice Conditions of
Participation, Part 418 subpart 54. Centers for Medicare and
Medicaid Services, June 5, 2008.
---------------------------------------------------------------------------

Measure Importance. This composite quality measure for
comprehensive assessment at admission addresses high priority aspects
of quality hospice care as identified by both leading hospice
stakeholders and beneficiaries receiving hospice services. The NCP for
Quality Palliative Care Clinical Practice Guidelines for Quality
Palliative Care established 8 core palliative care domains, and this
composite measure captures 4 of those domains.\20\ The 4 domains
captured by this composite measure are: The Structure and Process of
Care Domain; the Physical Aspects of Care Domain; the Spiritual,
Religious, and Existential Aspects of Care Domain, and the Ethical and
Legal Aspects of Care Domain. The NCP guidelines placed equal weight on
both the physical and psychosocial domains, emphasizing a comprehensive
approach to patient care. For more information on the NCP domains for
palliative care, refer to: https://www.nationalconsensusproject.org/guidelines_download2.aspx. In addition, the Medicare Hospice CoPs
require that hospice comprehensive assessments identify patients'
physical, psychosocial, emotional, and spiritual needs, and address
them to promote the hospice patient's comfort throughout the end-of-
life process. Furthermore, the person-centered, family, and caregiver
perspective align with the domains identified by the CoPs and NCP, as
patients and their families/caregiver also place value on physical
symptom management and spiritual/psychosocial care as important factors
at the end of life.^{21 22} A composite measure serves to
ensure all hospice patients receive a comprehensive assessment for both
physical and psychosocial needs at admission.
---------------------------------------------------------------------------

\20\ The National Consensus Project for Quality Palliative Care
Clinical Practice Guidelines for Quality Palliative Care 3rd edition
2013.
\21\ Singer PA, Martin DK, Kelner M. Quality End-of-Life Care:
Patients' Perspectives. JAMA. 1999;281(2):163-168. doi:10.1001/
jama.281.2.163.
\22\ Steinhauser KE, Christakis NA, Clipp EC, McNeilly M,
McIntyre L, Tulsky JA. Factors Considered Important at the End of
Life by Patients, Family, Physicians, and Other Care Providers.
JAMA. 2000;284(19):2476-2482. doi:10.1001/jama.284.19.2476.
---------------------------------------------------------------------------

Measure Impact. The literature indicates that health care
providers' practice is responsive to quality measures reported.\23\ We
believe this research, while not specific to hospices, reasonably
predicts the effect of measures on hospice provider behavior.
Collecting information about the total number of care processes
conducted for each patient will incentivize hospices to conduct all
desirable care processes for each patient and provide services that
will address their care needs and improve quality during the time he/
she is receiving hospice care. Additionally, creating a composite
quality measure for comprehensive assessment at admission will provide
consumers and providers with a single measure regarding the overall
quality and completeness of assessment of patient needs at hospice
admission, which can then be used to meaningfully and easily compare
quality across hospice providers and increase transparency.
---------------------------------------------------------------------------

\23\ Werner, R., E. Stuart, and D. Polsky, Public reporting
drove quality gains at nursing homes. Health Affairs, 2010. 29(9):
p. 1706-1713.
---------------------------------------------------------------------------

Performance Gap. Analyses conducted by our measure development
contractor, RTI International, show that hospice performance scores on
the current 7 HQRP measures are high (a score of 90 percent or higher)
however, these analyses also revealed that, on average, only 68.1
percent of patient stays in a hospice had documentation that all of
these desirable care processes were done at admission. Thus, by
assessing hospices' performance of comprehensive assessment, the
composite measure sets a higher standard of care for hospices and
reveals a larger performance gap. A similar effect has been shown in
the literature where facilities are achieving more than 90 percent
compliance with individual measures, but compliance numbers decrease
when multiple measures are combined as one.^{24 25} The
performance gap identified by the composite measure creates
opportunities for quality improvement and may motivate providers to
conduct a greater number of high priority care processes for as many
patients as possible upon admission to hospice.
---------------------------------------------------------------------------

\24\ Nolan, T., & Berwick, D. M. (2006). All-or-none measurement
raises the bar on performance. JAMA [H.W. Wilson--GS], 295(10),
1168.
\25\ Agency for Healthcare Research and Quality. (2004).
National Healthcare Quality Report.
---------------------------------------------------------------------------

Existing Measures. The Family Evaluation of Hospice Care (FEHC),
NQF #0208, is a precursor of the Hospice CAHPS[supreg]. The surveys
cover some similar domains. However, a major difference between them is
the detailed requirements for survey administration of the
CAHPS[supreg] Hospice Survey, which allow for comparison of hospice
programs, The Hospice CAHPS[supreg] survey quality measure is not yet
endorsed by NQF. We have recently submitted the CAHPS[supreg] Hospice
Survey (experience of care) measure (NQF #2651) to be considered for
endorsement under the Palliative and End-of-Life Care Project 2015-
2016. For more information regarding this project and the measure
submitted, we refer readers to https://www.qualityforum.org/ProjectMeasures.aspx?projectID=80663. In addition, we refer readers to
section III.E.9 of this proposed rule for more information on the
Hospice CAHPS[supreg] survey and associated quality

[[Page 25525]]

measures. The CAHPS[supreg]-based quality measures submitted to NQF
include patient and caregiver experience of care outcome measures, and
our plan to propose these measures as part of the HQRP measure set in
future rulemaking cycles. A key difference between the FEHC, Hospice
CAHPS[supreg] and the Hospice and Palliative Care Composite Process
Measure is that the FEHC and Hospice CAHPS[supreg] focus on the
consumer's perspective of their health agency and experience, whereas
the Hospice and Palliative Care Composite Process Measure focuses on
the clinical care processes that are actually delivered by the hospice
to each patient.
Stakeholder Support. A TEP convened by our measure development
contractor, RTI International, on December 2, 2015, provided input on
this measure concept. The TEP unanimously agreed that a comprehensive
hospice composite measure is an important measure and supported data
collection using the HIS. The NQF MAP met on December 14th and 15th,
2015 and provided input to CMS. In their final recommendation, the MAP
encouraged continued development of the Hospice and Palliative Care
Composite Process Measure--Comprehensive Assessment at Admission
measure. More information about the MAP's recommendations for this
measure is available at: https://www.qualityforum.org/ProjectMaterials.aspx?projectID=75370.
While this measure is not currently NQF-endorsed, we recognize that
the NQF endorsement process is an important part of measure development
and plan to submit this measure for NQF endorsement. As noted, this
quality measure will fill a gap by holding hospices to a higher
standard of care and will motivate providers to conduct a greater
number of high priority care processes for as many beneficiaries as
possible upon admission as hospice patients. Furthermore, no current
NQF-endorsed measures address the completion of a comprehensive care
assessment at hospice admission.
Form, Manner, and Timing of Data Collection and Submission. The
data source for this measure will be currently implemented HIS items
that are currently used in the calculation of the 7 component measures.
These items and quality measure algorithms for the 7 component measures
can be found in the HQRP Specifications for the Hospice Item Set-based
Quality Measures document, which is available in the ``Downloads''
section of the ``Current Measures'' portion of the CMS HQRP Web site:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html. Since the
proposed measure is a composite measure whose components are currently
adopted HQRP measures, no new data collection will be required; data
for the composite measure will come from existing items from the
existing 7 HQRP component measures. We propose to begin calculating
this measure using existing data items, beginning April 1, 2017; this
means patient admissions occurring after April 1, 2017 would be
included in the composite measure calculation.
Since the composite measure components are existing HIS data items,
providers are already collecting the data needed to calculate the
composite measure. Data collection will continue in accordance with
processes outlined in sections III.E.7c through III.E.7e of this
proposed rule.
For more information on the specifications and data elements for
the measure, Hospice and Palliative Care Composite Process Measure-
Comprehensive Assessment at Admission, we refer readers to the https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html document,
available on the ``Current Measures'' portion of the CMS HQRP Web site:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html.
We invite public comment on our proposal to implement the Hospice
and Palliative Care Composite Process Measure--Comprehensive Assessment
at Admission beginning April 1, 2017, as previously described for the
HQRP.

Table 16--Proposed Quality Measures and Data Collection Period Affecting the FY 2019 Payment Determination and
Subsequent Years
----------------------------------------------------------------------------------------------------------------
Data
Quality measure NQF ID No. Type Submission method collection to
begin
----------------------------------------------------------------------------------------------------------------
Hospice Visits when Death is TBD Process Measure...... Hospice Item Set..... 04/01/2017
Imminent.
Hospice and Palliative Care TBD
Composite Process Measure.
----------------------------------------------------------------------------------------------------------------

7. Form, Manner, and Timing of Quality Data Submission
a. Background
Section 1814(i)(5)(C) of the Act requires that each hospice submit
data to the Secretary on quality measures specified by the Secretary.
Such data must be submitted in a form and manner, and at a time
specified by the Secretary. Section 1814(i)(5)(A)(i) of the Act
requires that beginning with the FY 2014 and for each subsequent FY,
the Secretary shall reduce the market basket update by 2 percentage
points for any hospice that does not comply with the quality data
submission requirements for that FY.
b. Previously Finalized Policy for New Facilities To Begin Submitting
Quality Data
In the FY 2015 Hospice Wage Index final rule (79 FR 50488), we
finalized a policy stating that any hospice that receives its CMS
Certification Number (CCN) (also known as the Medicare Provider Number)
notification letter dated on or after November 1 of the preceding year
involved is excluded from any payment penalty for quality reporting
purposes for the following FY. This requirement was codified at Sec.
418.312.
In the FY 2016 Hospice Wage Index final rule (80 FR 47189), we
further clarified and finalized our policy for the timing of new
providers to begin reporting data to CMS. The clarified policy
finalized in the FY 2016 Hospice Wage Index final rule (80 FR 47189)
distinguished between when new hospice providers are required to begin
submitting HIS data and when providers will be subject to the potential
2 percentage point annual payment update (APU) reduction for failure to
comply with HQRP requirements. In summary, the policy finalized in the
FY 2016 Hospice Wage Index final rule (80 FR 47189 through 47190)
clarified that providers must begin submitting HIS data on the date
listed in the letterhead of the CCN Notification letter received

[[Page 25526]]

from us, but will be subject to the APU reduction based on whether the
CCN Notification letter was dated before or after November 1st of the
reporting year involved. Thus, beginning with the FY 2018 payment
determination and for each subsequent payment determination, we
finalized our policy that a new hospice be responsible for HQRP quality
data submission beginning on the date of the CCN notification letter;
we retained our prior policy that hospices not be subject to the APU
reduction if the CCN notification letter was dated after November 1st
of the year involved. For example, if a provider receives their CCN
notification letter and the date in the letterhead is November 5, 2016,
that provider will begin submitting HIS data for patient admissions
occurring after November 5, 2016. However, since the CCN notification
letter was dated after November 1st, they would not be evaluated for,
or subject to any payment penalties for the relevant FY APU update
(which in this instance is the FY 2018 APU, which is associated with
patient admissions occurring January 1, 2016 through December 31, 2016.
This policy allows us to receive HIS data on all patient admissions
on or after the date that a hospice receives its CCN notification
letter, while at the same time allowing hospices flexibility and time
to establish the necessary accounts for data submission, before they
are subject to the potential APU reduction for a given reporting year.
Currently, new hospices may experience a lag between Medicare
certification and receipt of their actual CCN Number. Since hospices
cannot submit data to the QIES ASAP system without a valid CCN Number,
we proposed that new hospices begin collecting HIS quality data
beginning on the date noted on the CCN notification letter. We believe
this policy will provide sufficient time for new hospices to establish
appropriate collection and reporting mechanisms to submit the required
quality data to CMS. Requiring quality data reporting beginning on the
date listed in the letterhead of the CCN notification letter aligns CMS
policy for requirements for new providers with the functionality of the
HIS data submission system (QIES ASAP).
c. Previously Finalized Data Submission Mechanism, Collection
Timelines, and Submission Deadlines for the FY 2017 Payment
Determination
In the FY 2015 Hospice Wage Index final rule (79 FR 50486), we
finalized our policy requiring that, for the FY 2017 reporting
requirements, hospices must complete and submit HIS records for all
patient admissions to hospice after July 1, 2014. For each HQRP program
year, we require that hospices submit data on each of the adopted
measures in accordance with the reporting requirements specified in
sections III.E.7c through III.E.7e of that FY 2015 Hospice Wage Index
final rule for the designated reporting period. This requirement
applies to previously finalized and adopted measures, as well as new
measures proposed through the rulemaking process. Electronic submission
is required for all HIS records. Although electronic submission of HIS
records is required, hospices do not need to have an electronic medical
record to complete or submit HIS data. In the FY 2014 Hospice Wage
Index final rule (78 FR 48258), we finalized that to complete HIS
records, providers can use either the Hospice Abstraction Reporting
Tool (HART) software, which is free to download and use, or vendor-
designed software. HART provides an alternative option for hospice
providers to collect and maintain facility, patient, and HIS Record
information for subsequent submission to the QIES ASAP system. Once HIS
records are complete, electronic HIS files must be submitted to CMS via
the QIES ASAP system. Electronic data submission via the QIES ASAP
system is required for all HIS submissions; there are no other data
submission methods available. Hospices have 30 days from a patient
admission or discharge to submit the appropriate HIS record for that
patient through the QIES ASAP system. We will continue to make HIS
completion and submission software available to hospices at no cost. We
provided details on data collection and submission timing under the
downloads section of the HIS Web site on the CMS.gov Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html.
The QIES ASAP system provides reports upon successful submission
and processing of the HIS records. The final validation report may
serve as evidence of submission. This is the same data submission
system used by nursing homes, inpatient rehabilitation facilities, home
health agencies, and long-term care hospitals for the submission of
Minimum Data Set Version 3.0 (MDS 3.0), Inpatient Rehabilitation
Facility-patient assessment instrument (IRF-PAI), Outcome Assessment
Information Set (OASIS), and Long-Term Care Hospital Continuity
Assessment Record and Evaluation Data Set (LTCH CARE), respectively. We
have provided hospices with information and details about use of the
HIS through postings on the HQRP Web site, Open Door Forums,
announcements in the CMS MLN Connects Provider e-News (E-News), and
provider training.
d. Previously Finalized Data Submission Timelines and Requirements for
FY 2018 Payment Determination and Subsequent Years
Hospices are evaluated for purposes of the quality reporting
program based on whether or not they submit data, not on their
substantive performance level for the required quality measures. In
order for us to appropriately evaluate the quality reporting data
received by hospice providers, it is essential HIS data be received in
a timely manner.
The submission date for any given HIS record is defined as the date
on which a provider submits the completed record. The submission date
is the date on which the completed record is submitted and accepted by
the QIES ASAP system. In the FY 2016 Hospice Wage Index final rule (80
FR 47191) we finalized our policy that beginning with the FY 2018
payment determination hospices must submit all HIS records within 30
days of the Event Date, which is the patient's admission date for HIS-
Admission records or discharge date for HIS-Discharge records.
For HIS-Admission records, the submission date must be no
later than the admission date plus 30 calendar days. The submission
date can be equal to the admission date, or no greater than 30 days
later. The QIES ASAP system will issue a warning on the Final
Validation Report if the submission date is more than 30 days after the
patient's admission date.
For HIS-Discharge records, the submission date must be no
later than the discharge date plus 30 calendar days. The submission
date can be equal to the discharge date, or no greater than 30 days
later. The QIES ASAP system will issue a warning on the Final
Validation Report if the submission date is more than 30 days after the
patient's discharge date.
The QIES ASAP system validation edits are designed to monitor the
timeliness and ensure that providers' submitted records conform to the
HIS data submission specifications. Providers are notified when timing
criteria have not been met by warnings that appear on their Final
Validation Reports. A standardized data collection approach that
coincides with timely submission of data is essential to establish a
robust quality reporting program and ensure the scientific reliability
of the data received.

[[Page 25527]]

In the FY 2016 Hospice Wage Index final rule (80 FR 47191), we
clarified the difference between the completion deadlines and the
submission deadlines. Current sub-regulatory guidance produced by CMS
(for example, HIS Manual, HIS trainings) states that the completion
deadlines for HIS records are 14 days from the Event Date for HIS-
Admission records and 7 days from the Event Date for HIS-Discharge
records. Completion deadlines continue to reflect CMS guidance only;
these guidelines are not statutorily specified and are not designated
through regulation. These guidelines are intended to offer clear
direction to hospice agencies in regards to the timely completion of
HIS-Admission and HIS-Discharge records. The completion deadlines
define only the latest possible date on which a hospice should complete
each HIS record. This guidance is meant to better align HIS completion
processes with clinical workflow processes; however, hospices may
develop alternative internal policies to complete HIS records. Although
it is at the discretion of the hospice to develop internal policies for
completing HIS records, we continue to recommend that providers
complete and attempt to submit HIS records early, prior to the
previously finalized submission deadline of 30 days, beginning in FY
2018. Completing and attempting to submit records early allows
providers ample time to address any technical issues encountered in the
QIES ASAP submission process, such as correcting fatal error messages.
Completing and attempting to submit records early will ensure that
providers are able to comply with the 30 day submission deadline. HQRP
guidance documents, including the CMS HQRP Web site, HIS Manual, HIS
trainings, Frequently Asked Questions (FAQs), and Fact Sheets continue
to offer the most up-to-date CMS guidance to assist providers in the
successful completion and submission of HIS records. Availability of
updated guidance will be communicated to providers through the usual
CMS HQRP communication channels, including postings and announcements
on the CMS HQRP Web site, MLN eNews communications, National provider
association calls, and announcements on Open Door Forums and Special
Open Door Forums.
e. Previously Finalized HQRP Data Submission and Compliance Thresholds
for the FY 2018 Payment Determination and Subsequent Years
To accurately analyze quality reporting data received by hospice
providers, it is imperative we receive ongoing and timely submission of
all HIS-Admission and HIS-Discharge records. In the FY 2016 Hospice
Wage Index final rule (80 FR 47192), we finalized the timeliness
criteria for submission of HIS-Admission and HIS-Discharge records in
response to input from our stakeholders seeking additional specificity
related to HQRP compliance affecting FY payment determinations and, due
to the importance of ensuring the integrity of quality data submitted.
Last year, we finalized our policy (80 FR 47191 through 47192) that
beginning with the FY 2018 payment determination and subsequent FY
payment determinations, all HIS records would have to be submitted
within 30 days of the event date, which is the patient's admission date
or discharge date. In conjunction with this requirement, we also
finalized our policy (80 FR 47192) to establish an incremental
threshold for compliance over a 3 year period. To be compliant for the
FY 2018 APU determination, hospices must submit no less than 70 percent
of their total number of HIS-Admission and HIS-Discharge records by no
later than 30 days from the event date. The timeliness threshold is set
at 80 percent for the FY 2019 APU determination and at 90 percent for
the FY 2020 APU determination and subsequent years. The threshold
corresponds with the overall amount of HIS records received from each
provider that fall within the established 30 day submission timeframes.
Our ultimate goal is to require all hospices to achieve a compliance
rate of 90 percent or more.
To summarize, in the FY 2016 Hospice Wage Index final rule (80 FR
47193), we finalized our policy to implement the timeliness threshold
requirement beginning with all HIS admission and discharge records that
occur after January 1, 2016, in accordance with the following schedule.
Beginning January 1, 2016 to December 31, 2016, hospices
must submit at least 70 percent of all required HIS records within the
30 day submission timeframe for the year or be subject to a 2
percentage point reduction to their market basket update for FY 2018.
Beginning January 1, 2017 to December 31, 2017, hospices
must submit at least 80 percent of all required HIS records within the
30 day submission timeframe for the year or be subject to a 2
percentage point reduction to their market basket update for FY 2019.
Beginning January 1, 2018 to December 31, 2018, hospices
must submit at least 90 percent of all required HIS records within the
30 day submission timeframe for the year or be subject to a 2
percentage point reduction to their market basket update for FY 2020.
Timely submission of data is necessary to accurately analyze
quality measure data received by providers. To support the feasibility
of a hospice to achieve the compliance thresholds, CMS's measure
development contractor conducted some preliminary analysis of Quarter 3
and Quarter 4 HIS data from 2014. According to this analysis, the vast
majority of hospices (92 percent) would have met the compliance
thresholds at 70 percent. Moreover, 88 percent and 78 percent of
hospices would have met the compliance thresholds at 80 percent and 90
percent, respectively. We believe this analysis is further evidence
that the compliance thresholds are reasonable and achievable by hospice
providers.
The current reports available to providers in the Certification and
Survey Provider Enhanced Reports (CASPER) system do allow providers to
track the number of HIS records that are submitted within the 30 day
submission timeframe. Currently, submitting an HIS record past the 30
day submission timeframe results in a non-fatal (warning) error. In
April 2015, we made available 3 new Hospice Reports in CASPER, which
include reports that can list HIS Record Errors by Field by Provider
and HIS records with a specific error number. We are working on
expanding this functionality of CASPER reports to include a timeliness
compliance threshold report that providers could run to determine their
preliminary compliance with the timeliness compliance requirement. We
expect these reports to be available by late spring/early summer of
2016.
In the FY 2016 Hospice Wage Index final rule (80 FR 47192 through
47193), we provided clarification regarding the methodology used in
calculating the 70 percent/80 percent/90 percent compliance thresholds.
In general, HIS records submitted for patient admissions and discharges
occurring during the reporting period (January 1st to December 31st of
the reporting year involved) will be included in the denominator for
the compliance threshold calculation. The numerator of the compliance
threshold calculation would include any records from the denominator
that were submitted within the 30 day submission deadline. In the FY
2016 Hospice Wage Index final rule (80 FR 47192), we stated that we
would make allowances in the calculation methodology for two (2)
circumstances. First, the calculation methodology will

[[Page 25528]]

be adjusted following the applicable reporting period for records for
which a hospice is granted an extension or exemption by CMS. Second,
adjustments will be made for instances of modification/inactivation
requests (Item A0050. Type of Record = 2 or 3). Additional helpful
resources regarding the timeliness compliance threshold for HIS
submissions can be found under the downloads section of the Hospice
Item Set Web site at CMS.gov at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html. Lastly, as further details of the data
submission and compliance threshold are determined by CMS, we
anticipate communicating these details through the regular CMS HQRP
communication channels, including postings and announcements on the CMS
HQRP Web site, MLN eNews communications, National provider association
calls, and announcements on Open Door Forums and Special Open Door
Forums.
f. New Data Collection and Submission Mechanisms Under Consideration
for Future Years
We have made great progress in implementing the objectives set
forth in the quality reporting and data collection activities required
by Sections 3004 and 3132 of the Affordable Care Act. To date, we have
established the HQRP, which includes 7 NQF-endorsed quality measures
that are collected via the HIS. As stated in this rule, data on these
measures are expected to be publicly reported sometime in 2017.
Additionally, we have implemented the Hospice CAHPS[supreg] as part of
the HQRP to gather important input on patient experience of care in
hospice. Over the past several years, we have conducted data collection
and analysis on hospice utilization and trends to help reform the
hospice payment system. In the FY 2016 Hospice Wage Index final rule,
we finalized payment reform measures, including changes to the RHC
payment rate and the implementation of a Service Intensity Add-On (SIA)
payment, effective January 1, 2016. As part of payment reform and
ongoing program integrity efforts, we will continue ongoing monitoring
of utilization trends for any future refinements.
To facilitate continued progress towards the requirements set forth
in both sections 3004 and 3132 of the Affordable Care Act, we are
considering developing a new data collection mechanism for use by
hospices. This new data collection mechanism would be a hospice patient
assessment instrument, which would serve 2 primary objectives
concordant with the Affordable Care Act legislation: (1) To provide the
quality data necessary for HQRP requirements and the current function
of the HIS; and (2) provide additional clinical data that could inform
future payment refinements.
We believe that the development of a hospice patient assessment
tool could offer several benefits over the current mechanisms of data
collection for quality and payment purposes, which include the
submission of HIS data and the submission of claims data. For future
payment refinements, a hospice patient assessment tool would allow us
to gather more detailed clinical information, beyond the patient
diagnosis and comorbidities that are currently reported on hospice
claims. As stated in the FY 2016 Hospice Wage Index final rule (80 FR
47203), detailed patient characteristics are necessary to determine
whether a case mix payment system could be achieved. A hospice patient
assessment tool would allow us to capture information on symptom
burden, functional status, and patient, family, and caregiver
preferences, all of which will inform future payment refinements.
While systematic assessment is vital throughout the continuum of
care, including palliative and end-of-life care, documentation
confirming completion of systematic assessment in hospice settings is
often inadequate or absent.\26\ The value of the introduction of
structured approaches via a clinical assessment is well established, as
it enables a more comprehensive and consistent way of identifying and
meeting patient needs.\27\
---------------------------------------------------------------------------

\26\ McMillan, S., Small, B., & Haley, W. (2011). Improving
Hospice Outcomes through Systematic Assessment: A Clinical Trial.
Cancer Nursing, 34(2), 89-97.
\27\ Bourbonnais, F.F., Perreault, A., & Bouvette, M. (2004).
Introduction of a pain and symptom assessment tool in the clinical
setting--lessons learned. Journal of Nursing Management, 12(3), 194-
200.
---------------------------------------------------------------------------

Moreover, symptoms are the leading reason that people seek medical
care in the first place and frequently serve as the basis for
establishing a diagnosis. Measures of physical function and disease
burden have been used to identify older adults at high-risk for excess
health care utilization, disability, or mortality.\28\ Currently, data
collected on claims includes line-item visits by discipline, General
Inpatient Care (GIP) visit reporting to hospice patients in skilled
nursing facilities or hospitals, post-mortem visits, injectable and
non-injectable drugs and infusion pumps. Industry representatives have
communicated to us that required claims information is not sufficiently
comprehensive to accurately reflect the provision and the cost of
hospice care.
---------------------------------------------------------------------------

\28\ Sha, M., Callahan, C., Counsell, S., Westmoreland, G.,
Stump, T., Kroenke, K. (2005). Physical symptoms as a predictor of
health care use and mortality among older adults. 118, 301-306.
---------------------------------------------------------------------------

For quality data collection, a hospice patient assessment
instrument would support the goals of the HQRP as new quality measures
are developed and adopted. Since the current quality data collection
tool (HIS) is a chart abstraction tool, not a hospice patient
assessment instrument, we are limited in the types of data that can be
collected via the HIS. Instead of retrospective data collection
elements, a hospice patient assessment tool would include data elements
designed to be collected concurrent with provision of care. As such, we
believe a hospice patient assessment tool would allow for more robust
data collection that could inform development of new quality measures
that are meaningful to hospice patients, their families and caregivers,
and other stakeholders.
Finally, a hospice patient assessment tool that provides clinical
data that is used for both payment and quality purposes would align the
hospice benefit with other care settings that use similar approaches,
such as nursing homes, inpatient rehabilitation facilities, and home
health agencies which submit data via the MDS 3.0, IRF-PAI, and OASIS,
respectively.
We envision the hospice patient assessment tool itself as an
expanded HIS. The hospice patient assessment tool would include current
HIS items, as well as additional clinical items that could be used for
payment refinement purposes or to develop new quality measures. The
hospice patient assessment tool would not replace existing requirements
set forth in the Medicare Hospice CoPs (such as the initial nursing and
comprehensive assessment), but would be designed to complement data
that are collected as part of normal clinical care. If such a patient
assessment were adopted, the new data collection effort would replace
the current HIS, but would not replace other HQRP data collection
efforts (that is, the Hospice CAHPS[supreg] survey), nor would it
replace regular submission of claims data. We envision that patient
assessment data would be collected upon a patient's admission to and
discharge from any Medicare-certified hospice provider; additional
interim data collection efforts are also possible. If we develop and
implement a hospice patient assessment tool, we would provide several
training opportunities to ensure providers are able to comply with any
new requirements.

[[Page 25529]]

We are not proposing a hospice patient assessment tool at this
time; we are still in the early stages of development of an assessment
tool to determine if it would be feasible to implement under the
Medicare Hospice Benefit. In the development of such a hospice patient
assessment tool, we will continue to receive stakeholder input from
MedPAC and ongoing input from the provider community, Medicare
beneficiaries, and technical experts. It is of the utmost importance to
develop a hospice patient assessment tool that is scientifically
rigorous and clinically appropriate, thus we believe that continued and
transparent involvement of stakeholders is critical. Additionally, it
is of the utmost importance to minimize data collection burden on
providers; in the development of any hospice patient assessment tool,
we will ensure that patient assessment data items are not duplicative
or overly burdensome to providers, patients, caregivers, or their
families.
We solicit comments on a potential hospice patient assessment tool
that would collect both quality, clinical, and other data with the
ability to be used to inform future payment refinement efforts.
8. HQRP Submission Exemption and Extension Requirements for the FY 2017
Payment Determination and Subsequent Years
In the FY 2015 Hospice Wage Index final rule (79 FR 50488), we
finalized our proposal to allow hospices to request, and for us to
grant exemptions/extensions for the reporting of required HIS quality
data when there are extraordinary circumstances beyond the control of
the provider. When an extension/exemption is granted, a hospice will
not incur payment reduction penalties for failure to comply with the
requirements of the HQRP. For the FY 2016 payment determination and
subsequent payment determinations, a hospice may request an extension/
exemption of the requirement to submit quality data for a specified
time period. In the event that a hospice requests an extension/
exemption for quality reporting purposes, the hospice would submit a
written request to CMS. In general, exemptions and extensions will not
be granted for hospice vendor issues, fatal error messages preventing
record submission, or staff error.
In the event that a hospice seeks to request an exemptions or
extension for quality reporting purposes, the hospice must request an
exemption or extension within 30 days of the date that the
extraordinary circumstances occurred by submitting the request to CMS
via email to the HQRP mailbox at
HospiceQRPReconsiderations@cms.hhs.gov. Exception or extension requests
sent to CMS through any other channel will not be considered valid. The
request for an exemption or extension must contain all of the finalized
requirements as outlined on our Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Extensions-and-Exemption-Requests.html.
If a hospice is granted an exemption or extension, timeframes for
which an exemption or extension is granted will be applied to the new
timeliness requirement so such hospices are not penalized. If a hospice
is granted an exemption, we will not require that the hospice submit
any quality data for a given period of time. By contrast, if we grant
an extension to a hospice, the hospice will still remain responsible
for submitting quality data collected during the timeframe in question,
although we will specify a revised deadline by which the hospice must
submit these quality data.
This process does not preclude us from granting extensions/
exemptions to hospices that have not requested them when we determine
that an extraordinary circumstance, such as an act of nature, affects
an entire region or locale. We may grant an extension/exemption to a
hospice if we determine that a systemic problem with our data
collection systems directly affected the ability of the hospice to
submit data. If we make the determination to grant an extension/
exemption to hospices in a region or locale, we will communicate this
decision through routine CMS HQRP communication channels, including
postings and announcements on the CMS HQRP Web site, MLN eNews
communications, National provider association calls, and announcements
on Open Door Forums and Special Open Door Forums.
9. Hospice CAHPS[supreg] Participation Requirements for the 2019 APU
and 2020 APU
National Implementation of the Hospice CAHPS[supreg] Survey started
January 1, 2015 as stated in the FY 2015 Hospice Wage Index and Payment
Rate Update final rule (79 FR 50452). The CAHPS[supreg] Hospice Survey
is a component of CMS' Hospice Quality Reporting Program that
emphasizes the experiences of hospice patients and their primary
caregivers listed in the hospice patients' records. Readers who want
more information are referred to our extensive discussion of the
Hospice Experience of Care Survey in the Hospice Wage Index FY 2015
final rule for a description of the measurements involved and their
relationship to the statutory requirement for hospice quality reporting
(79 FR 50450 and 78 FR 48261).
a. Background and Description of the Survey
The CAHPS[supreg] Hospice Survey is the first national hospice
experience of care survey that includes standard survey administration
protocols that allow for fair comparisons across hospices. Consistent
with many other CMS CAHPS[supreg] surveys that are publicly reported on
CMS Web sites, we will publicly report hospice data when at least 12
months of data are available, so that valid comparisons can be made
across hospice providers in the United States, in order to help
patients, family, friends, and caregivers choose the right hospice
program.
The goals of the CAHPS[supreg] Hospice Survey are to:
Produce comparable data on hospice patients' and
caregivers' perspectives of care that allow objective and meaningful
comparisons between hospices on domains that are important to
consumers.
Create incentives for hospices to improve their quality of
care through public reporting of survey results.
Hold hospice care providers accountable by informing the
public about the providers' quality of care.
Details regarding CAHPS[supreg] Hospice Survey national
implementation, and survey administration as well as participation
requirements, exemptions from the survey requirement, hospice patient
and caregiver eligibility criteria, fielding schedules, sampling
requirements, and the languages in which is questionnaire, are
available on the CAHPS[supreg] Web site, www.HospiceCAHPSsurvey.org and
in the Quality Assurance Guidelines (QAG) manual, which is also on the
same site and is available for download. Measures from the survey will
be submitted to the NQF for endorsement.
b. Participation Requirements To Meet Quality Reporting Requirements
for the FY 2019 APU
To meet participation requirements for the FY 2019 APU, hospices
must collect survey data on an ongoing monthly basis from January 2017
through December 2017 (inclusive). Data submission deadlines for the
2019 APU can be found in Table 17. The data must be submitted by the
deadlines listed in Table 17 by the hospice's authorized approved CMS
vendor.

[[Page 25530]]

Hospices provide lists of the patients who died under their care to
form the sample for the Hospice CAHPS[supreg] Survey. We emphasize the
importance of hospices providing complete and accurate information to
their vendors in a timely manner. Hospices must contract with an
approved Hospice CAHPS[supreg] Survey vendor to conduct the survey on
their behalf. The hospice is responsible for making sure their vendor
meets all data submission deadlines. Vendor failure to submit data on
time will be the responsibility of the hospice.

Table 17--CAHPS[supreg] Hospice Survey Data Submission Dates FY 2018
APU, FY 2019 APU, and FY 2020 APU
------------------------------------------------------------------------
Sample months (that is, month of death) Quarterly data submission
\1\ deadlines \2\
------------------------------------------------------------------------
FY 2018 APU
------------------------------------------------------------------------
January-March 2016 (Q1)................... August 10, 2016.
April-June 2016 (Q2)...................... November 9, 2016.
July-September 2016 (Q3).................. February 8, 2017.
October-December 2016 (Q4)................ May 10, 2017.
------------------------------------------------------------------------
FY 2019 APU
------------------------------------------------------------------------
January-March 2017 (Q1)................... August 9, 2017.
April-June 2017 (Q2)...................... November 8, 2017.
July-September 2017 (Q3).................. February 14, 2018.
October-December 2017 (Q4)................ May 9, 2018.
------------------------------------------------------------------------
FY 2020 APU
------------------------------------------------------------------------
January-March 2018 (Q1)................... August 8, 2018.
April-June 2018 (Q2)...................... November 14, 2018.
July-September 2018 (Q3).................. February 13, 2019.
October-December 2018 (Q4)................ May 8, 2019.
------------------------------------------------------------------------
\1\ Data collection for each sample month initiates 2 months following
the month of patient death (for example, in April for deaths occurring
in January).
\2\ Data submission deadlines are the second Wednesday of the submission
months, which are August, November, February, and May.

Hospices that have fewer than 50 survey-eligible decedents/
caregivers in the period from January 1, 2016 through December 31, 2016
are exempt from CAHPS[supreg] Hospice Survey data collection and
reporting requirements for the FY 2019 payment determination. To
qualify, hospices must submit an exemption request form. This form will
be available in first quarter 2017 on the CAHPS[supreg] Hospice Survey
Web site https://www.hospiceCAHPSsurvey.org. Hospices that want to claim
the size exemption are required to submit to CMS their total unique
patient count for the period of January 1, 2016 through December 31,
2016. The due date for submitting the exemption request form for the FY
2019 APU is August 10, 2017.
We propose that hospices that received their CCN after January 1,
2017, are exempted from the FY 2019 APU Hospice CAHPS[supreg]
requirements due to newness. This exemption will be determined by CMS.
The exemption is for 1 year only.
c. Participation Requirements To Meet Quality Reporting Requirements
for the FY 2020 APU
To meet participation requirements for the FY 2020 APU, hospices
must collect survey data on an ongoing monthly basis from January 2018
through December 2018 (inclusive). Data submission deadlines for the
2020 APU can be found in Table 17. The data must be submitted by the
deadlines in Table 17 by the hospice's authorized approved CMS vendor.
Hospices must contract with an approved Hospice CAHPS[supreg]
survey vendor to conduct the survey on their behalf. The hospice is
responsible for making sure their vendor meets all data submission
deadlines. Vendor failure to submit data on time will be the
responsibility of the hospice.
Hospices that have fewer than 50 survey-eligible decedents/
caregivers in the period from January 1, 2017 through December 31, 2017
are exempt from CAHPS[supreg] Hospice Survey data collection and
reporting requirements for the FY 2020 payment determination. To
qualify, hospices must submit an exemption request form. This form will
be available in first quarter 2018 on the CAHPS[supreg] Hospice Survey
Web site https://www.hospiceCAHPSsurvey.org. Hospices that want to claim
the size exemption are required to submit to CMS their total unique
patient count for the period of January 1, 2017 through December 31,
2017. The due date for submitting the exemption request form for the FY
2020 APU is August 10, 2018.
We propose that hospices that received their CCN after January 1,
2018, are exempted from the FY 2020 APU Hospice CAHPS[supreg]
requirements due to newness. This exemption will be determined by CMS.
The exemption is for 1 year only.
d. Annual Payment Update
The Affordable Care Act requires that beginning with FY 2014 and
each subsequent fiscal year, the Secretary shall reduce the market
basket update by 2 percentage points for any hospice that does not
comply with the quality data submission requirements for that fiscal
year, unless covered by specific exemptions. Any such reduction will
not be cumulative and will not be taken into account in computing the
payment amount for subsequent fiscal years. In the FY 2015 Hospice Wage
Index final rule, we added the CAHPS[supreg] Hospice Survey to the
Hospice Quality Reporting Program requirements for the FY 2017 payment
determination and determinations for subsequent years.
To meet the HQRP requirements for the FY 2018 payment
determination, hospices would collect survey data on a monthly basis
for the months of January 1, 2016 through December 31, 2016 to qualify
for the full APU.

[[Page 25531]]

To meet the HQRP requirements for the FY 2019 payment
determination, hospices would collect survey data on a monthly basis
for the months of January 1, 2017 through December 31, 2017 to qualify
for the full APU.
To meet the HQRP requirements for the FY 2020 payment
determination, hospices would collect survey data on a monthly basis
for the months of January 1, 2018 through December 31, 2018 to qualify
for the full APU.
e. Hospice CAHPS[supreg] Reconsiderations and Appeals Process
Hospices are required to monitor their respective Hospice
CAHPS[supreg] Survey vendors to ensure that vendors submit their data
on time. The hospice CAHPS[supreg] data warehouse provides reports to
vendors and hospices, including reports on the status of their data
submissions. Details about the reports and emails received after data
submission should be referred to the Quality Assurance Guidelines
Manual. If a hospice does not know how to retrieve their reports, or
lacks access to the reports, they should contact Hospice CAHPS[supreg]
Technical Assistance at hospiceCAHPSsurvey@hcqis.org or call them at 1-
844 -472-4621. Additional information can be found on page 113 of the
Hospice CAHPS[supreg] Quality Assurance Guidelines manual Version 2.0
which is available on the Hospice CAHPS[supreg] Web site,
www.hospicecahpssurvey.org.
In the FY 2017 payment determination and subsequent years,
reporting compliance is determined by successfully fulfilling both the
Hospice CAHPS[supreg] Survey requirements and the HIS data submission
requirements. Providers would use the same process for submitting a
reconsideration request that are outlined in section III.C.10 of this
proposed rule.
10. HQRP Reconsideration and Appeals Procedures for the FY 2017 Payment
Determination and Subsequent Years
In the FY 2015 Hospice Wage Index final rule (79 FR 50496), we
notified hospice providers on how to seek reconsideration if they
received a noncompliance decision for the FY 2016 payment determination
and subsequent years. A hospice may request reconsideration of a
decision by CMS that the hospice has not met the requirements of the
Hospice Quality Reporting Program for a particular period. For the FY
2017 payment determination and subsequent years, reporting compliance
is determined by successfully fulfilling both the Hospice CAHPS[supreg]
Survey requirements and the HIS data submission requirements.
We clarified that any hospice that wishes to submit a
reconsideration request must do so by submitting an email to CMS
containing all of the requirements listed on the HQRP Web site at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Reconsideration-Requests.html.
Electronic email sent to HospiceQRPReconsiderations@cms.hhs.gov is the
only form of submission that will be accepted. Any reconsideration
requests received through any other channel including the United States
Postal Service or phone will not be considered as a valid
reconsideration request. We codified this process at Sec. 418.312(h).
In addition, we codified at Sec. 418.306(b)(2) that beginning with FY
2014 and each subsequent FY, the Secretary shall reduce the market
basket update by 2 percentage points for any hospice that does not
comply with the quality data submission requirements for that FY and
solicited comments on all of the proposals and the associated
regulations text at Sec. 418.312 and in Sec. 418.306. Official
instructions regarding the payment reduction reconsideration process
can be located under the Regulations and Guidance, Transmittals, 2015
Transmittals Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2015-Transmittals-Items/R52QRI.html?DLPage=1&DLEntries=10&DLSort=4&DLSortDir=descending.
In the past, only hospices found to be non-compliant with the
reporting requirements set forth for a given payment determination
received a notification from CMS of this finding along with
instructions for requesting reconsideration in the form of a United
States Postal Service (USPS) letter. In the FY 2016 Hospice Wage Index
final rule (80 FR 47198), we proposed to use the QIES CASPER reporting
system as an additional mechanism to communicate to hospices regarding
their compliance with the reporting requirements for the given
reporting cycle. We will implement this additional communication
mechanism via the QIES CASPER timeliness compliance reports. As stated
in section III.E.7e, of this proposed rule these QIES CASPER reports
will be automated reports that hospices will be able to generate at any
point in time to determine their preliminary compliance with HQRP
requirements, specifically, the timeliness compliance threshold for the
HIS. We believe the QIES CASPER timeliness compliance reports meet our
intent of developing a method to communicate as quickly, efficiently,
and broadly as possible with hospices regarding their preliminary
compliance with reporting requirements. We will continue to send
notification of noncompliance via delivery of a letter via the United
States Postal Service. Requesting access to the CMS systems is
performed in 2 steps. Details are provided on the QIES Technical
Support Office Web site at https://www.qtso.com/hospice.html. Providers
may access the CMS QIES Hospice Users Guides and Training on the QIES
Technical Support Office Web site and selecting Hospice and then
selecting the CASPER Reporting Users Guide at https://www.qtso.com/hospicetrain.html. Additional information about how to access the QIES
CASPER reports will be provided prior to the availability of these new
reports.
We proposed to disseminate communications regarding the
availability of hospice compliance reports in CASPER files through CMS
HQRP communication channels, including postings and announcements on
the CMS HQRP Web site, MLN eNews communications, National provider
association calls, and announcements on Open Door Forums and Special
Open Door Forums. We further proposed to publish a list of hospices who
successfully meet the reporting requirements for the applicable payment
determination on the CMS HQRP Web site https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/. We proposed updating the list after
reconsideration requests are processed on an annual basis. We clarified
that the published list of compliant hospices on the CMS HQRP Web site
would include limited organizational data, such as the name and
location of the hospice. Finalizing the list of compliant providers for
any given year is most appropriately done after the final determination
of compliance is made. It is our intent for the published list of
compliant hospices to be as complete and accurate as possible, giving
recognition to all providers who were compliant with HQRP requirements
for that year. Finalizing the list after requests for reconsideration
are reviewed and a final determination of compliance is made allows for
a more complete and accurate listing of compliant providers than
developing any such list prior to reconsideration. Developing the list
after the final determination of compliance has been made allows
providers whose initial determination of noncompliance was

[[Page 25532]]

reversed to be included in the list of compliant hospices for that
year. We believe that finalizing the list of compliant hospices
annually, after the reconsideration period will provide the most
accurate listing of hospices compliant with HQRP requirements.
11. Public Display of Quality Measures and Other Hospice Data for the
HQRP
Under section 1814(i)(5)(E) of the Act, the Secretary is required
to establish procedures for making any quality data submitted by
hospices available to the public. Such procedures shall ensure that a
hospice program has the opportunity to review the data that is to be
made public for the hospice program prior to such data being made
public. The Secretary shall report quality measures that relate to
hospice care provided by hospice programs on the CMS Web site.
We recognize that public reporting of quality data is a vital
component of a robust quality reporting program and are fully committed
to developing the necessary systems for transparent public reporting of
hospice quality data. We also recognize that it is essential that the
data made available to the public be meaningful and that comparing
performance between hospices requires that measures be constructed from
data collected in a standardized and uniform manner. Hospices have been
required to use a standardized data collection approach (HIS) since
July 1, 2014. Data from July 1, 2014 onward is currently being used to
establish the scientific soundness of the quality measures prior to the
onset of public reporting of the 7 quality measures implemented in the
HQRP. We believe it is critical to establish the reliability and
validity of the quality measures prior to public reporting to
demonstrate the ability of the quality measures to distinguish the
quality of services provided. To establish reliability and validity of
the quality measures, at least 4 quarters of data will be analyzed.
Typically, the first 1 or 2 quarters of data reflect the learning curve
of the facilities as they adopt standardized data collection
procedures; these data often are not used to establish reliability and
validity. We began data collection in CY 2014; the data from CY 2014
for Quarter 3 (Q3) was not used for assessing validity and reliability
of the quality measures. We analyzed data collected by hospices during
Quarter 4 (Q4) CY 2014 and Q1-Q3 CY 2015. Preliminary analyses of HIS
data show that all 7 quality measures that can be calculated using HIS
data are eligible for public reporting (NQF #1634, NQF #1637, NQF
#1639, NQF #1638, NQF #1641, modified NQF #1647, NQF #1617). Based on
analyses conducted to establish reportability of the measures, 71
percent-90 percent of all hospices would be able to participate in
public reporting, depending on the measure. For additional details
regarding analysis, we refer readers to the Measure Testing Executive
Summary document available on the ``Current Measures'' section of the
CMS HQRP Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html. Although analyses show that many hospices perform well
on the 7 measures from the HIS measure set, the measures still show
variation, especially among hospices with suboptimal performance,
indicating that these measures are still meaningful for comparing
quality of care across hospice providers. In addition to conducting
quantitative analysis to establish scientific acceptability of the HIS
measures, CMS's measure development contractor, RTI International, also
conducted interviews with family and caregivers of hospice patients.
The purpose of these interviews was to determine what information
patients and caregivers would find useful in selecting hospices, as
well as gathering input about patient and caregiver experience with
hospice care. Results from these interviews indicate that all 7 HIS
quality measures provide consumers with useful information. Interview
participants stated that quality measure data would be especially
helpful in identifying poor quality outliers that inform beneficiaries,
families, caregivers, and other hospice stakeholders.
To inform which of the HIS measures are eligible for public
reporting, CMS's measure development contractor, RTI International,
examined the distribution of hospice-level denominator size for each
quality measure to assess whether the denominator size is large enough
to generate the statistically reliable scores necessary for public
reporting. This goal of this analysis is to establish the minimum
denominator size for public reporting, and is referred to as
``reportability'' analysis. Reportability analysis is necessary since
small denominators may not yield statistically meaningful QM scores.
Thus, for other quality reporting programs, such as Nursing Home
Compare,\29\ CMS sets a minimum denominator size for public reporting,
as well as the data selection period necessary to generate the minimum
denominator size. Reportability analysis showed that calculating and
publicly displaying measures based on 12 months of data would allow for
sufficient measure denominator size. Having ample denominator size
ensures that quality measure scores that are publicly reported are
reliable and stable; a minimum sample size of 20 stays is commonly
applied to assessment-based quality measures in other reporting
programs. The 12 month data selection period produced significantly
larger mean and median sample sizes among hospices, which will generate
more reliable quality measure scores. Additionally, our analysis
revealed that when applying a minimum sample size of 20 stays, using
rolling 12 months of data to create QMs would only exclude about 10
percent-29 percent of hospices from public reporting, depending on the
measure. For more information on analyses conducted to determine
minimum denominator size and data selection period, we refer readers to
the Reportability Analysis Section of the Measure Testing Executive
Summary, available on the ``Current Measures'' portion of the CMS HQRP
Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html.
---------------------------------------------------------------------------

\29\ ``CMS Nursing Home Quality Initiative--Centers for
Medicare* * *'' 2011. 25 Jan. 2016, https://www.cms.gov/nursinghomequalityinits/45_nhqimds30trainingmaterials.asp.
---------------------------------------------------------------------------

Based on reportability analysis and input from other stakeholders,
we have determined that all 7 HIS measures are eligible for public
reporting. Thus, we plan to publicly report all 7 HIS measures on a CMS
Compare Web site for hospice agencies. For more details on each of the
7 measures, including information on measure background, justification,
measure specifications, and measure calculation algorithms, we refer
readers to the HQRP QM User's Manual v1.00 Final document, which is
available on the downloads portion of the Hospice Item Set Web site,
CMS HQRP Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Current-Measures.html. Individual scores for each of the 7 HIS measure scores
would be reported on a new publicly available CMS Hospice Compare Web
site. Current reportability analysis indicates that a minimum
denominator size of 20 based on 12 rolling months of data would be
sufficient for public reporting of all HIS quality measures. Under this
methodology, hospices with a quality measure denominator size of
smaller than 20 patient stays would not have the

[[Page 25533]]

quality measure score publicly displayed since a quality measure score
on the basis of small denominator size may not be reliable. We will
continue to monitor quality measure performance and reportability and
will adjust public reporting methodology in the future if needed.
Reportability analysis is typically conducted on a measure-by-
measure basis. We would like to clarify that any new measure adopted as
part of the HQRP will undergo reportability analysis to determine: (1)
if the measure is eligible for public reporting; and (2) the data
selection period and minimum denominator size for the measure. Results
of reportability analyses conducted for new measures will be
communicated through future rulemaking.
In addition, the Affordable Care Act requires that reporting be
made public on a CMS Web site and that providers have an opportunity to
review their data prior to public reporting. We are currently
developing the infrastructure for public reporting, and will provide
hospices an opportunity to review their quality measure data prior to
publicly reporting information about the quality of care provided by
Medicare-certified hospice agencies throughout the nation. These
quality measure data reports or ``preview reports'' will be made
available in the CASPER system prior to public reporting and will offer
providers the opportunity to review their quality measure data prior to
public reporting on the CMS Compare Web site for hospice agencies.
Under this process, providers would have the opportunity to review and
correct data they submit on all measures that are derived from the HIS.
Reports would contain the provider's performance on each measure
calculated based on HIS submission to the QIES ASAP system. The data
from the HIS submissions would be populated into reports with all data
that have been submitted by the provider. We will post preview reports
with sufficient time for providers to be able to submit, review data,
make corrections to the data, and view their data. Providers are
encouraged to regularly evaluate their performance in an effort to
ensure the most accurate information regarding their agency is
reflected.
We also plan to make available additional provider-level feedback
reports, which are separate from public reporting and will be for
provider viewing only, for the purposes of internal provider quality
improvement. As is common in other quality reporting programs, quality
reports would contain feedback on facility-level performance on quality
metrics, as well as benchmarks and thresholds. For the CY 2015
Reporting Cycle, several new quality reporting provider participation
reports were made available in CASPER. Providers can access a detailed
list and description of each of the 12 reports currently available to
hospices on the QIES Web site, under the Training and Education
Selections, CASPER Reporting Users Guide at https://www.qtso.com/hospicetrain.html. We anticipate that providers would use the quality
reports as part of their Quality Assessment and Performance Improvement
(QAPI) efforts.
Furthermore, to meet the requirement for making such data public,
we are developing a CMS Hospice Compare Web site, which will provide
valuable information regarding the quality of care provided by
Medicare-certified hospice agencies throughout the nation. Consumers
would be able to search for all Medicare approved hospice providers
that serve their city or zip code (which would include the quality
measures and CAHPS[supreg] Hospice Survey results) and then find the
agencies offering the types of services they need, along with provider
quality information. Based on the efforts necessary to build the
infrastructure for public reporting, we anticipate that public
reporting of the eligible HIS quality measures on the CMS Compare Web
site for hospice agencies will begin sometime in the spring/summer of
CY 2017. To help providers prepare for public reporting, we will offer
opportunities for stakeholder engagement and education prior to the
rollout of a Hospice Compare site. We will offer outreach opportunities
for providers through the MLN eNews, Open Door Forums and Special Open
Door Forums; we will also post additional educational materials
regarding public reporting on the CMS HQRP Web site. Finally, we will
offer training to all hospice providers on the systems and processes
for reviewing their data prior to public reporting; availability of
trainings will be communicated through the regular CMS HQRP
communication channels, including postings and announcements on the CMS
HQRP Web site, MLN eNews communications, National provider association
calls, and announcements on Open Door Forums and Special Open Door
Forums.
Like other CMS Compare Web sites, the Hospice Compare Web site
will, in time, feature a quality rating system that gives each hospice
a rating of between 1 and 5 stars. Hospices will have prepublication
access to their own agency's quality data, which enables each agency to
know how it is performing before public posting of data on the Hospice
Compare Web site. Public comments regarding how the rating system would
determine a hospice's star rating and the methods used for
calculations, as well as a proposed timeline for implementation will be
announced via regular CMS HQRP communication channels, including
postings and announcements on the CMS HQRP Web site, MLN eNews
communications, provider association calls, and announcements on Open
Door Forums and Special Open Door Forums. We will announce the timeline
for development and implementation of the star rating system in future
rulemaking.
Lastly, as part of our ongoing efforts to make healthcare more
transparent, affordable, and accountable for all hospice stakeholders,
the HQRP is prepared to post hospice data on a public data set, the
Data.Medicare.gov Web site, and directory located at https://data.medicare.gov. This site includes the official datasets used on the
Medicare.gov Compare Web sites provided by CMS. In addition, this data
will serve as a helpful resource regarding information on Medicare-
certified hospice agencies throughout the nation. In an effort to move
toward public reporting of hospice data, we will initially post
demographic data of hospice agencies that have been registered with
Medicare. This list will include addresses, phone numbers, and services
provided for each agency. The timeline for posting hospice demographic
data on a public dataset is scheduled for sometime late spring/summer
CY 2016. Additional details regarding hospice datasets will be
announced via regular CMS HQRP communication channels, including
postings and announcements on the CMS HQRP Web site, MLN eNews
communications, National provider association calls, and announcements
on Open Door Forums and Special Open Door Forums. In addition, we will
provide the applicable list of CASPER/ASPEN coordinators in the event
the Medicare-certified agency is either not listed in the database or
the characteristics/administrative data (name, address, phone number,
services, or type of ownership) is incorrect or has changed. To
continue to meet Medicare enrollment requirements, all Medicare
providers are required to report changes to their information in their
enrollment application as outlined in the Provider -Supplier Enrollment
Fact Sheet Series located at https://www.cms.gov/Outreach-and-
Education/Medicare-Learning-Network-MLN/MLNProducts/

[[Page 25534]]

downloads/MedEnroll_InstProv_FactSheet_ICN903783.pdf.

D. The Medicare Care Choices Model

The Medicare Care Choices Model (MCCM) offers a new option for
Medicare 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 5 year model
is being tested to encourage greater and earlier use of the Medicare
and Medicaid hospice benefit to determine whether it can improve the
quality of life and care received by Medicare beneficiaries, increase
beneficiary, family, and caregiver satisfaction, and reduce Medicare or
Medicaid expenditures. Participation in the model will be limited to
Medicare and dual eligible beneficiaries with advanced cancers, chronic
obstructive pulmonary disease (COPD), congestive heart failure, and
Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome who
qualify for the Medicare or Medicaid hospice benefit and meet the
eligibility requirements of the model. The model includes over 130
hospices from 39 states across the country and is projected to serve
100,000 beneficiaries by 2020. The first cohort of MCCM participating
hospices began providing services under the model in January 2016, and
the second cohort will begin to provide services under the model in
January 2018. The last patient will be accepted into the model 6 months
before the December 31, 2020 model end date.
For more information, see the MCCM Web site: https://innovation.cms.gov/initiatives/Medicare-Care-Choices/.

IV. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. To
fairly evaluate whether an information collection should be approved by
OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995
requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of the following
information collection requirements (ICRs).

A. Proposed Information Collection Requirements

Section 1814(i)(5)(C) of the Act requires that each hospice submit
data to the Secretary on quality measures specified by the Secretary.
Such data must be submitted in a form and manner, and at a time
specified by the Secretary. In the FY 2014 Hospice Wage Index final
rule (78 FR 48257), and in compliance with section 1814(i)(5)(C) of the
Act, we finalized the specific collection of data items that support
the following six NQF endorsed measures and one modified measure for
hospice:
NQF #1617 Patients Treated with an Opioid who are Given a
Bowel Regimen,
NQF #1634 Pain Screening,
NQF #1637 Pain Assessment,
NQF #1638 Dyspnea Treatment,
NQF #1639 Dyspnea Screening,
NQF #1641 Treatment Preferences,
NQF #1647 Beliefs/Values Addressed (if desired by the
patient) (modified).
Data for the aforementioned 7 measures is collected via the HIS.
Data collection for the 7 NQF-endorsed measures via the HIS V1.00.0 was
approved by the Office of Management and Budget April 3, 2014 (OMB
control number 0938-1153--Hospice Quality Reporting Program). As
outlined in this proposed rule, we continue data collection for these 7
NQF-endorsed measures.
In this proposed rule, we propose the implementation of two new
measures. The first measure is the Hospice and Palliative Care
Composite Process Measure--Comprehensive Assessment at Admission. Seven
individual care processes will be captured in this composite measure,
which includes the six NQF-endorsed quality measures and one modified
NQF-endorsed quality measure currently implemented in the HQRP. Thus,
the Hospice and Palliative Care Composite Process quality measure will
use the current HQRP quality measures as its components. The data
source for this measure will be currently implemented HIS items that
are currently used in the calculation of the seven component measures.
Since the proposed measure is a composite measure created from
components, which are currently adopted HQRP measures, no new data
collection will be required; data for the composite measure will come
from existing items from the existing seven HQRP component measures. We
propose to begin calculating this measure using existing data items,
beginning April 1, 2017; this means patient admissions occurring on or
after April 1, 2017, would be included in the composite measure
calculation.
The second measure is the Hospice Visits when Death is Imminent
Measure Pair. Data for this measure would be collected via the existing
data collection mechanism, the HIS. We proposed that four new items be
added to the HIS-Discharge record to collect the necessary data
elements for this measure. We expect that data collection for this
quality measure via the four 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 on or after April 1, 2017.
We proposed the HIS V2.00.0 to fulfill the data collection
requirements for the 7 currently adopted NQF measures and the 2 new
proposed measures. The HIS V2.00.0 contains:
All items from the HIS V1.00.0, which are necessary to
calculate the 7 adopted NQF measures (and thus the proposed composite
measure), plus the HIS V1.00.0 administrative items necessary for
patient identification and record matching
One new item for measure refinement of the existing
measure NQF #1637 Pain Assessment.
New items to collect data for the Hospice Visits when
Death is Imminent measure pair.
New administrative items for patient record matching and
future public reporting of hospice quality data.
Hospice providers will submit an HIS-Admission and an HIS-Discharge
for each patient admission. Using HIS data for assessments submitted
October 1, 2014 through September 30, 2015, we have estimated that
there will be approximately 1,248,419 discharges across all hospices
per year; therefore, we would expect that there should be 1,248,419 HIS
(consisting of one admission and one discharge assessment per patient),
submitted across all hospices yearly. Over a 3-year period, we expect
3,745,257 Hospice Item Sets across all hospices. There were 4,259
certified hospices in the United States as of January 2016; \30\ we
estimate that each individual hospice

[[Page 25535]]

will submit on average 293 Hospice Item Sets annually, which is
approximately 24 Hospice Items Sets per month or 879 Hospice Item Sets
over three years.
---------------------------------------------------------------------------

\30\ Quality Improvement and Evaluation System (QIES) List of
Hospice Providers, January 2016.
---------------------------------------------------------------------------

The HIS consists of an admission assessment and a discharge
assessment. As noted above, we estimate that there will be 1,248,419
hospice admissions across all hospices per year. Therefore, we expect
there to be 2,496,838 HIS assessment submissions (admission and
discharge assessments counted separately) submitted across all hospices
annually, which is 208,070 across all hospices monthly, or 7,490,514
across all hospices over 3 years. We further estimate that there will
be 586 Hospice Item Set submissions by each hospice annually, which is
approximately 49 submissions monthly or 1,759 submissions over 3 years.
For the Admission Hospice Item Set, we estimate that it will take
14 minutes of time by a clinician such as a Registered Nurse at an
hourly wage of $67.10 \31\ to abstract data for Admission Hospice Item
Set. This would cost the facility approximately $15.66 for each
admission assessment. We further estimate that it will take 5 minutes
of time by clerical or administrative staff person such as a medical
data entry clerk or medical secretary at an hourly wage of $32.24 \32\
to upload the Hospice Item Set data into the CMS system. This would
cost each facility approximately $2.69 per assessment. For the
Discharge Hospice Item Set, we estimate that it will take 9 minutes of
time by a clinician, such as a nurse at an hourly wage of $67.10 to
abstract data for Discharge Hospice Item Set. This would cost the
facility approximately $10.07. We further estimate that it will take 5
minutes of time by clerical or administrative staff, such as a medical
data entry clerk or medical secretary at an hourly wage of $32.24 to
upload data into the CMS system. This would cost each facility
approximately $2.69. The estimated cost for each full Hospice Item Set
submission (admission assessment and discharge assessment) is $31.10.
---------------------------------------------------------------------------

\31\ The adjusted hourly wage of $67.10 per hour for a
Registered Nurse was obtained using the mean hourly wage from the
U.S. Bureau of Labor Statistics, $33.55. This mean hourly wage is
adjusted by a factor of 100 percent to include fringe benefits. See
https://www.bls.gov/oes/current/oes291141.htm.
\32\ The adjusted hourly wage of $32.24 per hour for a Medical
Secretary was obtained using the mean hourly wage from the U.S.
Bureau of Labor Statistics, $16.12. This mean hourly wage is
adjusted by a factor of 100 percent to include fringe benefits. See
https://www.bls.gov/oes/current/oes436013.htm.
---------------------------------------------------------------------------

We estimate that the total nursing time required for completion of
both the admission and discharge assessments is 23 minutes at a rate of
$67.10 per hour. The cost across all Hospices for the nursing/clinical
time required to complete both the admission and discharge Hospice Item
sets is estimated to be $32,111,417 annually, or $96,334,252 over 3
years, and the cost to each individual Hospice is estimated to be
$7,539.66 annually, or $22,618.98 over 3 years. The estimated time
burden to hospices for a medical data entry clerk to complete the
admission and discharge Hospice Item Set assessments is 10 minutes at a
rate of $32.24 per hour. The cost for completion of the both the
admission and discharge Hospice Item sets by a medical data entry clerk
is estimated to be $6,708,171 across all Hospices annually, or
$20,124,514 across all Hospices over 3 years, and $1,575.06 to each
Hospice annually, or $4,725.17 to each Hospice over 3 years.
The total combined time burden for completion of the Admission and
Discharge Hospice Item Sets is estimated to be 33 minutes. The total
cost across all hospices is estimated to be $38,819,589 annually or
$116,458,766 over 3 years. For each individual hospice, this cost is
estimated to be $9,114.72 annually or $27,344.16 over 3 years. See
Table 17 for breakdown of burden and cost by assessment form.

Table 17--Summary of Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
OMB Number of Burden per response annual Hourly labor cost Total cost
Regulation section(s) control respondents Number of responses (hours) burden of reporting ($) ($)
No. (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hospice Item Set Admission 0938-1153 4,259 1,248,419 per year.... 0.233 clinician 395,333 Clinician at $67.10 $22,900,166
Assessment. hours; 0.083 per hour; Clerical
clerical hours. staff at $32.24 per
hour.
Hospice Item Set Discharge 0938-1153 4,259 1,248,419 per year.... 0.150 clinician 291,298 Clinician at $67.10 15,919,423
Assessment. hours; 0.083 per hour; Clerical
clerical hours. staff at $32.24 per
hour.
3-year total...................... 0938-1153 4,259 7,490,514............. 0.55 hours........... 2,059,891 Clinician at $67.10 116,458,766
per hour; Clerical
staff at $32.24 per
hour.
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Submission of PRA-Related Comments

We have submitted a copy of this proposed rule to OMB for its
review of the rule's information collection and recordkeeping
requirements. These requirements are not effective until they have been
approved by the OMB.
To obtain copies of the supporting statement and any related forms
for the proposed collections discussed above, please visit CMS' Web
site at www.cms.hhs.gov/Paperwork@cms.hhs.gov">www.cms.hhs.gov/Paperwork@cms.hhs.gov, or call the Reports
Clearance Office at 410-786-1326.
We invite public comments on these potential information collection
requirements. If you wish to comment, please submit your comments
electronically as specified in the ADDRESSES section of this proposed
rule and identify the rule (CMS-1652-P) the ICR's CFR citation, CMS ID
number, and OMB control number.
ICR-related comments are due June 27, 2016.

V. Economic Analyses

A. Regulatory Impact Analysis

1. Introduction
We have examined the impacts of this proposed rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), the Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96-354), section 1102(b) of

[[Page 25536]]

the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA,
March 22, 1995; Pub. L. 104-4), and the Congressional Review Act (5
U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. A regulatory impact analysis (RIA) must be prepared for
major rules with economically significant effects ($100 million or more
in any 1 year). This proposed rule has been designated as economically
significant under section 3(f)(1) of Executive Order 12866 and thus a
major rule under the Congressional Review Act. Accordingly, we have
prepared a regulatory impact analysis (RIA) that, to the best of our
ability, presents the costs and benefits of the rulemaking. This
proposed rule was also reviewed by OMB.
2. Statement of Need
This proposed rule meets the requirements of our regulations at
Sec. 418.306(c), which requires annual issuance, in the Federal
Register, of the hospice wage index based on the most current available
CMS hospital wage data, including any changes to the definitions of
Core-Based Statistical Areas (CBSAs), or previously used Metropolitan
Statistical Areas (MSAs). This proposed rule would also update payment
rates for each of the categories of hospice care described in Sec.
418.302(b) for FY 2017 as required under section 1814(i)(1)(C)(ii)(VII)
of the Act. The payment rate updates are subject to changes in economy-
wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the
Act. In addition, the payment rate updates may be reduced by an
additional 0.3 percentage point (although for FY 2014 to FY 2019, the
potential 0.3 percentage point reduction is subject to suspension under
conditions specified in section 1814(i)(1)(C)(v) of the Act). In 2010,
the Congress amended section 1814(i)(6) of the Act with section 3132(a)
of the Affordable Care Act. The amendment authorized the Secretary to
revise the methodology for determining the payment rates for routine
home care and other services included in hospice care, no earlier than
October 1, 2013. In the FY 2016 Hospice Wage Index and Rate Update
final rule (80 FR 47164), we finalized the creation of two different
payment rates for RHC that resulted in a higher base payment rate for
the first 60 days of hospice care and a reduced base payment rate for
days 61 and over of hospice and created a SIA payment, in addition to
the per diem rate for the RHC level of care, equal to the CHC hourly
payment rate multiplied by the amount of direct patient care provided
by an RN or social worker that occurs during the last 7 days of a
beneficiary's life, if certain criteria are met. Finally, section 3004
of the Affordable Care Act amended the Act to authorize a quality
reporting program for hospices and this rule discusses changes in the
requirements for the hospice quality reporting program in accordance
with section 1814(i)(5) of the Act.
3. Overall Impacts
We estimate that the aggregate impact of this proposed rule would
be an increase of $330 million in payments to hospices, resulting from
the hospice payment update percentage of 2.0 percent. The impact
analysis of this proposed rule represents the projected effects of the
changes in hospice payments from FY 2016 to FY 2017. Using the most
recent data available at the time of rulemaking, in this case FY 2015
hospice claims data, we apply the current FY 2016 wage index and labor-
related share values to the level of care per diem payments and SIA
payments for each day of hospice care to simulate FY 2016 payments.
Then, using the same FY 2015 data, we apply the proposed FY 2017 wage
index and labor-related share values to simulate FY 2017 payments.
Certain events may limit the scope or accuracy of our impact analysis,
because such an analysis is susceptible to forecasting errors due to
other changes in the forecasted impact time period. The nature of the
Medicare program is such that the changes may interact, and the
complexity of the interaction of these changes could make it difficult
to predict accurately the full scope of the impact upon hospices.
4. Detailed Economic Analysis
The FY 2017 hospice payment impacts appear in Table 19. We tabulate
the resulting payments according to the classifications in Table 19
(for example, facility type, geographic region, facility ownership),
and compare the difference between current and proposed payments to
determine the overall impact.
The first column shows the breakdown of all hospices by urban or
rural status, census region, hospital-based or freestanding status,
size, and type of ownership, and hospice base. The second column shows
the number of hospices in each of the categories in the first column.
The third column shows the effect of the annual update to the wage
index. This represents the effect of using the proposed FY 2017 hospice
wage index. The aggregate impact of this change is zero percent, due to
the proposed hospice wage index standardization factor. However, there
are distributional effects of the proposed FY 2017 hospice wage index.
The fourth column shows the effect of the proposed hospice payment
update percentage for FY 2017. The proposed 2.0 percent hospice payment
update percentage for FY 2017 is based on an estimated 2.8 percent
inpatient hospital market basket update, reduced by a 0.5 percentage
point productivity adjustment and by a 0.3 percentage point adjustment
mandated by the Affordable Care Act, and is constant for all providers.
The fifth column shows the effect of all the proposed changes on FY
2017 hospice payments. It is projected that aggregate payments will
increase by 2.0 percent, assuming hospices do not change their service
and billing practices in response.
As illustrated in Table 19, the combined effects of all the
proposals vary by specific types of providers and by location. For
example, due to the changes proposed in this rule, the estimated
impacts on FY 2017 payments range from a 1.0 percent increase for
hospices providing care in the rural West North Central region to a 2.7
percent increase for hospices providing care in the rural Pacific
region.

[[Page 25537]]

Table 19--Projected Impact to Hospices for FY 2017
----------------------------------------------------------------------------------------------------------------
Proposed
Number of Updated wage hospice FY 2017 total
providers data (%) payment change (%)
update (%)
(1) (2) (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
All Hospices.................................... 4,142 0.0 2.0 2.0
Urban Hospices.................................. 3,151 0.0 2.0 2.0
Rural Hospices.................................. 991 -0.1 2.0 1.9
Urban Hospices--New England..................... 137 0.4 2.0 2.4
Urban Hospices--Middle Atlantic................. 252 0.2 2.0 2.2
Urban Hospices--South Atlantic.................. 419 -0.1 2.0 1.9
Urban Hospices--East North Central.............. 396 -0.1 2.0 1.9
Urban Hospices--East South Central.............. 160 -0.1 2.0 1.9
Urban Hospices--West North Central.............. 218 -0.5 2.0 1.5
Urban Hospices--West South Central.............. 610 -0.2 2.0 1.8
Urban Hospices--Mountain........................ 312 -0.3 2.0 1.7
Urban Hospices--Pacific......................... 608 0.6 2.0 2.6
Urban Hospices--Outlying........................ 39 -0.7 2.0 1.3
Rural Hospices--New England..................... 23 -0.4 2.0 1.6
Rural Hospices--Middle Atlantic................. 41 -0.2 2.0 1.8
Rural Hospices--South Atlantic.................. 136 0.2 2.0 2.2
Rural Hospices--East North Central.............. 139 0.1 2.0 2.1
Rural Hospices--East South Central.............. 129 -0.1 2.0 1.9
Rural Hospices--West North Central.............. 184 -1.0 2.0 1.0
Rural Hospices--West South Central.............. 183 -0.2 2.0 1.8
Rural Hospices--Mountain........................ 106 -0.2 2.0 1.8
Rural Hospices--Pacific......................... 47 0.7 2.0 2.7
Rural Hospices--Outlying........................ 3 -0.1 2.0 1.9
0--3,499 RHC Days (Small)....................... 887 0.0 2.0 2.0
3,500-19,999 RHC Days (Medium).................. 2,000 0.0 2.0 2.0
20,000+ RHC Days (Large)........................ 1,255 0.0 2.0 2.0
Non-Profit Ownership............................ 1,069 0.1 2.0 2.1
For Profit Ownership............................ 2,523 -0.1 2.0 1.9
Govt Ownership.................................. 159 0.5 2.0 2.5
Other Ownership................................. 391 -0.1 2.0 1.9
Freestanding Facility Type...................... 3,151 0.0 2.0 2.0
HHA/Facility-Based Facility Type................ 991 0.1 2.0 2.1
----------------------------------------------------------------------------------------------------------------
Source: FY 2015 hospice claims data from the Standard Analytic Files for CY 2014 (as of June 30, 2015) and CY
2015 (as of December 31, 2015).
Region Key:
New England= Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont; Middle Atlantic =
Pennsylvania, New Jersey, New York; South Atlantic = Delaware, District of Columbia, Florida, Georgia,
Maryland, North Carolina, South Carolina, Virginia, West Virginia; East North Central = Illinois, Indiana,
Michigan, Ohio, Wisconsin; East South Central = Alabama, Kentucky, Mississippi, Tennessee; West North Central
= Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota; West South Central = Arkansas,
Louisiana, Oklahoma, Texas; Mountain = Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming;
Pacific = Alaska, California, Hawaii, Oregon, Washington; Outlying = Guam, Puerto Rico, Virgin Islands.

5. Alternatives Considered
Since the hospice payment update percentage is determined based on
statutory requirements, we did not consider not updating hospice
payment rates by the payment update percentage. The proposed 2.0
percent hospice payment update percentage for FY 2017 is based on a
proposed 2.8 percent inpatient hospital market basket update for FY
2017, reduced by a 0.5 percentage point productivity adjustment and by
an additional 0.3 percentage point. Payment rates since FY 2002 have
been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act,
which states that the update to the payment rates for subsequent years
must be the market basket percentage for that FY. Section 3401(g) of
the Affordable Care Act also mandates that, starting with FY 2013 (and
in subsequent years), the hospice payment update percentage will be
annually reduced by changes in economy-wide productivity as specified
in section 1886(b)(3)(B)(xi)(II) of the Act. In addition, section
3401(g) of the Affordable Care Act mandates that in FY 2013 through FY
2019, the hospice payment update percentage will be reduced by an
additional 0.3 percentage point (although for FY 2014 to FY 2019, the
potential 0.3 percentage point reduction is subject to suspension under
conditions specified in section 1814(i)(1)(C)(v) of the Act).
We considered not proposing a hospice wage index standardization
factor. However, as discussed in section III.C.1 of this proposed rule,
we believe that adopting a hospice wage index standardization factor
would provide a safeguard to the Medicare program, as well as to
hospices, because it will mitigate changes in overall hospice
expenditures due to annual fluctuations in the hospital wage data from
year-to-year by ensuring that hospice wage index updates and revisions
are implemented in a budget neutral manner. We estimate that if the
hospice wage index standardization factor is not finalized, total
payments in a given year would increase or decrease by as much as 0.3
percent or $50 million.
6. Accounting Statement
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Table 20, we have
prepared an accounting statement showing the classification of the
expenditures

[[Page 25538]]

associated with the provisions of this proposed rule. Table 20 provides
our best estimate of the possible changes in Medicare payments under
the hospice benefit as a result of the policies in this proposed rule.
This estimate is based on the data for 4,067 hospices in our impact
analysis file, which was constructed using FY 2015 claims available as
of December 31, 2015. All expenditures are classified as transfers to
hospices.

Table 20--Accounting Statement: Classification of Estimated Transfers,
From FY 2016 to FY 2017
[In $millions]
------------------------------------------------------------------------
Category Transfers
------------------------------------------------------------------------
FY 2017 Hospice Wage Index and Payment Rate Update
------------------------------------------------------------------------
Annualized Monetized Transfers............ $330.*
From Whom to Whom? Federal Government to
Medicare Hospices.
------------------------------------------------------------------------
* The net increase of $330 million in transfer payments is a result of
the 2.0 percent hospice payment update percentage compared to payments
in FY 2016.

7. Conclusion
We estimate that aggregate payments to hospices in FY 2017 would
increase by $330 million, or 2.0 percent, compared to payments in FY
2016. We estimate that in FY 2017, hospices in urban and rural areas
would experience, on average, a 2.0 percent and a 1.9 percent increase,
respectively, in estimated payments compared to FY 2016. Hospices
providing services in the urban Pacific and rural Pacific regions would
experience the largest estimated increases in payments of 2.6 percent
and 2.7 percent, respectively. Hospices serving patients in rural areas
in the West North Central region would experience the lowest estimated
increase of 1.0 percent in FY 2017 payments.

B. Regulatory Flexibility Act Analysis

The RFA requires agencies to analyze options for regulatory relief
of small businesses if a rule has a significant impact on a substantial
number of small entities. The great majority of hospitals and most
other health care providers and suppliers are small entities by meeting
the Small Business Administration (SBA) definition of a small business
(in the service sector, having revenues of less than $7.5 million to
$38.5 million in any 1 year), or being nonprofit organizations. For
purposes of the RFA, we consider all hospices as small entities as that
term is used in the RFA. HHS's practice in interpreting the RFA is to
consider effects economically ``significant'' only if they reach a
threshold of 3 to 5 percent or more of total revenue or total costs.
The effect of the proposed FY 2017 hospice payment update percentage
results in an overall increase in estimated hospice payments of 2.0
percent, or $330 million. Therefore, the Secretary has determined that
this proposed rule will not create a significant economic impact on a
substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a metropolitan
statistical area and has fewer than 100 beds. This proposed rule only
affects hospices. Therefore, the Secretary has determined that this
proposed rule would not have a significant impact on the operations of
a substantial number of small rural hospitals.

C. Unfunded Mandates Reform Act Analysis

Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2016, that
threshold is approximately $146 million. This proposed rule is not
anticipated to have an effect on State, local, or tribal governments,
in the aggregate, or on the private sector of $146 million or more.

VI. Federalism Analysis and Regulations Text

Executive Order 13132, Federalism (August 4, 1999) requires an
agency to provide federalism summary impact statement when it
promulgates a proposed rule (and subsequent final rule) that has
federalism implications and which imposes substantial direct
requirement costs on State and local governments which are not required
by statute. We have reviewed this proposed rule under these criteria of
Executive Order 13132, and have determined that it will not impose
substantial direct costs on State or local governments.

List of Subjects in 42 CFR Part 418

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

For the reasons set forth in the preamble, the Centers for Medicare
and Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:

PART 418--HOSPICE CARE

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

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

0
2. Section 418.312 is amended by adding paragraph (i) to read as
follows:

Sec. 418.312 Data submission requirements under the hospice quality
reporting program.

* * * * *
(i) Retention of HQRP Measures Adopted for Previous Payment
Determinations. If HQRP measures are re-endorsed by the NQF without
substantive changes in specifications, CMS will implement the measure
without notice and comment rulemaking.

Dated: April 1, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: April 14, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-09631 Filed 4-21-16; 4:15 pm]
BILLING CODE 4120-01-P

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