Federal Register/Vol. 81, No. 180/Friday, September 16, 2016
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63860 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations DEPARTMENT OF HEALTH AND AAR/IP After Action Report/Improvement HSPD Homeland Security Presidential HUMAN SERVICES Plan Directive ACHC Accreditation Commission for HVA Hazard Vulnerability Analysis or Centers for Medicare & Medicaid Health Care, Inc. Assessment Services ACHE American College of Healthcare ICFs/IID Intermediate Care Facilities for Executives Individuals with Intellectual Disabilities AHA American Hospital Association ICR Information Collection Requirements 42 CFR Parts 403, 416, 418, 441, 460, AO Accrediting Organization IDG Interdisciplinary Group 482, 483, 484, 485, 486, 491, and 494 AOA/HFAP American Osteopathic IOM Institute of Medicine [CMS–3178–F] Association/Healthcare Facilities JPATS Joint Patient Assessment and Accreditation Program Tracking System RIN 0938–AO91 ASC Ambulatory Surgical Center LEP Limited English Proficiency ARCAH Accreditation Requirements for LD Leadership Medicare and Medicaid Programs; Critical Access Hospitals LPHA Local Public Health Agencies Emergency Preparedness ASPR Assistant Secretary for Preparedness LSC Life Safety Code Requirements for Medicare and and Response LTC Long Term Care Medicaid Participating Providers and BLS Bureau of Labor Statistics MMRS Metropolitan Medical Response Suppliers BTCDP Bioterrorism Training and System Curriculum Development Program MRC Medical Reserve Corps AGENCY: Centers for Medicare & CAH Critical Access Hospital MS Medical Staff Medicaid Services (CMS), HHS. CAMCAH Comprehensive Accreditation NDMS National Disaster Medical System Manual for Critical Access Hospitals NFs Nursing Facilities ACTION: Final rule. CAMH Comprehensive Accreditation NFPA National Fire Protection Association NIMS National Incident Management SUMMARY: This final rule establishes Manual for Hospitals CASPER Certification and the Survey System national emergency preparedness Provider Enhanced Reporting NIOSH National Institute for Occupational requirements for Medicare- and CDC Centers for Disease Control and Safety and Health Medicaid-participating providers and Prevention NLTN National Laboratory Training suppliers to plan adequately for both CON Certificate of Need Network natural and man-made disasters, and CfCs Conditions for Coverage and NRP National Response Plan coordinate with federal, state, tribal, Conditions for Certification NRF National Response Framework regional, and local emergency CHAP Community Health Accreditation NSS National Security Staff preparedness systems. It will also assist Program OBRA Omnibus Budget Reconciliation Act providers and suppliers to adequately CMHC Community Mental Health Center OIG Office of the Inspector General CMS Centers for Medicare and Medicaid OPHPR Office of Public Health prepare to meet the needs of patients, Services Preparedness and Response residents, clients, and participants COI Collection of Information OPO Organ Procurement Organization during disasters and emergency CoPs Conditions of Participation OPT Outpatient Physical Therapy situations. Despite some variations, our CORF Comprehensive Outpatient OPTN Organ Procurement and regulations will provide consistent Rehabilitation Facilities Transplantation Network emergency preparedness requirements, CPHP Centers for Public Health OSHA Occupational Safety and Health enhance patient safety during Preparedness Administration emergencies for persons served by CRI Cities Readiness Initiative PACE Program for the All-Inclusive Care for Medicare- and Medicaid-participating DHS Department of Homeland Security the Elderly DHHS Department of Health and Human PAHPA Pandemic and All-Hazards facilities, and establish a more Services Preparedness Act coordinated and defined response to DNV GL Det Norske Veritas GL—Healthcare PAHPRA Pandemic and All-Hazards natural and man-made disasters. DOL Department of Labor Preparedness Reauthorization Act DATES: Effective date: These regulations DPU Distinct Part Units PCT Patient Care Technician are effective on November 15, 2016. DSA Donation Service Area PPE Personal Protection Equipment Incorporation by reference: The EOP Emergency Operations Plans PHEP Public Health Emergency incorporation by reference of certain EC Environment of Care Preparedness publications listed in the rule is EMP Emergency Management Plan PHS Act Public Health Service Act approved by the Director of the Federal EP Emergency Preparedness PIN Policy Information Notice ESAR–VHP Emergency System for Advance PPD Presidential Policy Directive Register November 15, 2016. Registration of Volunteer Health PRTF Psychiatric Residential Treatment Implementation date: These Professionals Facilities regulations must be implemented by ESF Emergency Support Function QAPI Quality Assessment and Performance November 15, 2017. ESRD End-Stage Renal Disease Improvement FOR FURTHER INFORMATION CONTACT: FEMA Federal Emergency Management QIES Quality Improvement and Evaluation Janice Graham, (410) 786–8020. Agency System Mary Collins, (410) 786–3189. FDA Food and Drug Administration RFA Regulatory Flexibility Act Diane Corning, (410) 786–8486. FORHP Federal Office of Rural Health RNHCIs Religious Nonmedical Health Care Kianna Banks (410) 786–3498. Policy Institutions Ronisha Blackstone, (410) 786–6882. FRI Federal Reserve Inventories RHC Rural Health Clinic Alpha-Banu Huq, (410) 786–8687. FQHC Federally Qualified Health Center SAMHSA Substance Abuse and Mental Lisa Parker, (410) 786–4665. GAO Government Accountability Office Health Services Administration HFAP Healthcare Facilities Accreditation SLP Speech Language Pathology SUPPLEMENTARY INFORMATION: Program SNF Skilled Nursing Facility Acronyms HHA Home Health Agencies SNS Strategic National Stockpile HPP Hospital Preparedness Program TEFRA Tax Equity and Fiscal AAAHC Accreditation Association for HRSA Health Resources and Services Responsibility Act Ambulatory Health Care, Inc. Administration TFAH Trust for America’s Health AAAASF American Association for HSC Homeland Security Council TJC The Joint Commission Accreditation for Ambulatory Surgery HSEEP Homeland Security Exercise and TRACIE Technical Resources, Assistance Facilities, Inc. Evaluation Program Center, and Information Exchange VerDate Sep<11>2014 19:01 Sep 15, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\16SER2.SGM 16SER2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations 63861 TTX Tabletop Exercise R. Emergency Preparedness Regulations for that establish a comprehensive, UMRA Unfunded Mandates Reform Act Rural Health Clinics (RHCs) and consistent, flexible, and dynamic UNOS United Network for Organ Sharing Federally Qualified Health Centers regulatory approach to emergency UPMC University of Pittsburgh Medical (FQHCs) (§ 491.12) preparedness and response that Center S. Emergency Preparedness Regulations for WHO World Health Organization End-Stage Renal Disease (ESRD) incorporates the lessons learned from Facilities (§ 494.62) the past, combined with the proven best Table of Contents III. Provisions of the Final Regulations practices of the present. We recognize I. Overview A. Changes Included in the Final Rule that central to this approach is to A. Executive Summary B. Incorporation by Reference develop and guide emergency 1. Purpose IV. Collection of Information preparedness and response within the 2. Summary of the Major Provisions V. Regulatory Impact Analysis framework of our national healthcare B. Current State of Emergency VI. Waiver of Proposed Rulemaking system. To this end, these requirements Preparedness I. Overview also encourage providers and suppliers C. Statutory and Regulatory Background to coordinate their preparedness efforts II. Provisions of the Proposed Rule and A. Executive Summary within their own communities and Responses to Public Comments A. General Comments 1. Purpose states as well as across state lines, as 1. Integrated Health Systems We have reviewed existing Medicare necessary, to achieve their goals. 2. Requests for Technical Assistance and emergency regulatory preparedness 2. Summary of the Major Provisions Funding requirements for both providers and We are issuing emergency 3. Requirement To Track Patients and Staff suppliers. We found that many B. Implementation Date preparedness requirements that will be C. Emergency Preparedness Regulations for providers and suppliers have emergency consistent and enforceable for all Hospitals (§ 482.15) preparedness requirements, but those affected Medicare and Medicaid 1. Risk Assessment and Emergency Plan requirements do not go far enough in providers and suppliers (referred to (§ 482.15(a)) ensuring that these providers and collectively as ‘‘facilities,’’ throughout 2. Policies and Procedures (§ 482.15(b) suppliers are equipped and prepared to the remainder of this final rule where 3. Communication Plan (§ 482.15(c) help protect those they serve during 4. Training and Testing (§ 482.15(d) applicable). This final rule addresses the emergencies and disasters. Hospitals, for three key essentials we believe are 5. Emergency Fuel and Generator Testing example, are currently required to have (§ 482.15(e) necessary for maintaining access to D. Emergency Preparedness Regulations for emergency power and lighting in some healthcare services during emergencies: Religious Nonmedical Health Care specified areas and there must be safeguarding human resources, Institutions (RNHCIs) (§ 403.748) facilities for emergency