The Medicare Regulations for Hospice Care, Including the ...

The Medicare Regulations for Hospice Care, Including the Conditions of Participation for Hospice Care 42 CFR 418

Current as of January 4, 2022 Includes regulatory changes published in:

FY 2022 Hospice Wage Index Final Rule CMS Vaccine Mandate Interim Final Rule

These regulations may also be found in the Code of Federal Regulations (CFR) at 42 CFR 418. The electronic version of the Code of Federal Regulations is updated daily.

Prepared as a member benefit by:

National Hospice and Palliative Care Organization 1731 King Street, Suite 100 Alexandria, VA 22315 (703) 837-1500

For questions, send email to regulatory@

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INTRODUCTION

Medicare regulations for hospices (42 CFR 418), including the Medicare Hospice Conditions of Participation (CoPs) for Hospice Care (Subparts C and D) have been in existence since 1983, and most recently revised in their entirety in 2008. Since 2008, there have been numerous changes in regulations which are included here. NHPCO has created this easy-to-read version as a replica of the electronic Code of Federal Regulations. Pay particular attention to the date on this document as it will change as regulations are changed or added through the rulemaking process. Since these are the rules that govern all Medicare-certified hospices, they are a must read for hospice staff.

These Medicare Hospice regulations include all changes since 1983, including changes due to the Balanced Budget Act of 1997 (BBA), the Balanced Budget Refinement Act of 1999 (BBRA), the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), the Medicare Modernization Act of 2003 (MMA), Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care (Regulatory Burden) final rule, September 30, 2019, revisions to the Physician Fee Schedule for Calendar Year 2005 and Calendar Year 2020, and hospice wage index and quality reporting final rules issued as regulations specifically for hospices.

Hospice payment reform: Hospice payment reform changes were published in the Federal Register on August 6, 2015. They included the first phases of hospice payment reform, including the establishment of a two-tiered routine home care rate (RHC) and a Service Intensity Add-on (SIA) for visits by an RN or social worker during the last 7 days of a patient's life. The RHC changes are based on a beneficiary's length of stay, with a higher rate for the first 60 days of care and a lower rate starting on day 61. Both are effective January 1, 2016.

Emergency preparedness: The Emergency Preparedness Final Rule, posted on September 8, 2016, and published in the Federal Register on September 16, 2016, added a new Condition of Participation, found at ? 418.113, and revised the fire protection provisions of ? 418.110 to comply. Under ? 418.113 a hospice must develop and maintain an emergency preparedness plan, including a communication plan, along with supporting policies and procedures. The plan must also include training and testing of the emergency program. Original implementation date was November 15, 2017, with amendments in the Regulatory Burden final rule with an implementation date of November 29, 2019.

Regulatory burden: Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care (Regulatory Burden) final rule, published on September 30, 2019 has five hospice provisions:

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1. Defers hospice aide training and competencies to state licensure requirements. If there are no state requirements, hospices will still be required to ensure that their hospice aides meet Federal standards for hospice aide training.

2. Removes requirements to have a person on the hospice staff that has specialty knowledge of hospice medications.

3. Follows the statutory requirement in the SUPPORT Act that the hospice must share the written policies and procedures for drug disposal in the home with patients, families and caregivers. However, CMS encourages hospices to develop easily understood materials that explain safe storage, use, and disposal of controlled drugs to patients, their families, and caregivers in addition to meeting the statutory requirement.

4. Removes requirements for hospices to explicitly coordinate with SNF/NF and ICF/IID staff for orientation of facility staff.

5. Changes emergency preparedness requirements for hospice inpatient facilities and homebased hospice care.

All changes were effective November 29, 2019. Physician assistants: The Medicare Program; FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements published in the Federal Register on August 6, 2018 included the addition of the physician assistant as a hospice attending physician, effective January 1, 2019. The CY2020 Physician Fee Schedule final rule added changes to the Medicare Hospice Conditions of Participation to clarify the ability of PAs to order drugs, effective January 1, 2020. NOTE: 2022 changes are in red.

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TABLE OF CONTENTS Contents

INTRODUCTION .................................................................................................................................2 Subpart A--General Provision and Definitions ....................................................................................7

?418.1 Statutory basis............................................................................................................................. 7 ?418.2 Scope of part. .............................................................................................................................. 7 ?418.3 Definitions. .................................................................................................................................. 7 Subpart B--Eligibility, Election and Duration of Benefits ...................................................................10 ?418.20 Eligibility requirements. .......................................................................................................... 10 ?418.21 Duration of hospice care coverage--Election periods............................................................ 10 ?418.22 Certification of terminal illness. .............................................................................................. 11 ?418.24 Election of hospice care. ......................................................................................................... 13 ?418.25 Admission to hospice care. ..................................................................................................... 17 ?418.26 Discharge from hospice care................................................................................................... 17 ?418.28 Revoking the election of hospice care. ................................................................................... 18 ?418.30 Change of the designated hospice. ......................................................................................... 19 Subpart C--Conditions of Participation: Patient Care ........................................................................20 ?418.52 Condition of participation: Patient's rights. ............................................................................ 20 ?418.54 Condition of participation: Initial and comprehensive assessment of the patient................. 21 ?418.56 Condition of participation: Interdisciplinary group, care planning, and coordination of services.................................................................................................................................................... 23 ?418.58 Condition of participation: Quality assessment and performance improvement. ................. 25 ?418.60 Condition of participation: Infection control. ......................................................................... 26

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?418.62 Condition of participation: Licensed professional services..................................................... 28 Core Services....................................................................................................................................... 29

?418.64 Condition of participation: Core services................................................................................ 29 ?418.66 Condition of participation: Nursing services--Waiver of requirement that substantially all nursing services be routinely provided directly by a hospice................................................................. 30

Non-Core Services............................................................................................................................... 31 ?418.70 Condition of participation: Furnishing of non-core services................................................... 31 ?418.72 Condition of participation: Physical therapy, occupational therapy, and speech-language pathology. ............................................................................................................................................... 31 ?418.74 Waiver of requirement--Physical therapy, occupational therapy, speech-language pathology, and dietary counseling.......................................................................................................... 32 ?418.76 Condition of participation: Hospice aide and homemaker services. ...................................... 32 ?418.78 Conditions of participation--Volunteers. ............................................................................... 38 Subpart D--Conditions of participation: Organizational Environment................................................39 ?418.100 Condition of Participation: Organization and administration of services............................. 39 ?418.102 Condition of participation: Medical director. ....................................................................... 41 ?418.104 Condition of participation: Clinical records. ......................................................................... 42 ?418.106 Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment............................................................................................................................................... 43 ?418.108 Condition of participation: Short-term inpatient care.......................................................... 46 ?418.110 Condition of participation: Hospices that provide inpatient care directly. .......................... 47 ?418.112 Condition of participation: Hospices that provide hospice care to residents of a SNF/NF or ICF/IID. .................................................................................................................................................... 55 ?418.113 Condition of participation: Emergency preparedness. ......................................................... 58 ?418.114 Condition of participation: Personnel qualifications. ........................................................... 63

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