CMC Rule In Healthcare Emergency Management Discussio

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FR Parts 403, 416, 418, et al. Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers; Final Rule VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\16SER2.SGM 16SER2 63860 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 403, 416, 418, 441, 460, 482, 483, 484, 485, 486, 491, and 494 [CMS–3178–F] RIN 0938–AO91 Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. AGENCY: This final rule establishes national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to plan adequately for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It will also assist providers and suppliers to adequately prepare to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. Despite some variations, our regulations will provide consistent emergency preparedness requirements, enhance patient safety during emergencies for persons served by Medicare- and Medicaid-participating facilities, and establish a more coordinated and defined response to natural and man-made disasters. DATES: Effective date: These regulations are effective on November 15, 2016. Incorporation by reference: The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register November 15, 2016. Implementation date: These regulations must be implemented by November 15, 2017. FOR FURTHER INFORMATION CONTACT: Janice Graham, (410) 786–8020. Mary Collins, (410) 786–3189. Diane Corning, (410) 786–8486. Kianna Banks (410) 786–3498. Ronisha Blackstone, (410) 786–6882. Alpha-Banu Huq, (410) 786–8687. Lisa Parker, (410) 786–4665. SUPPLEMENTARY INFORMATION: mstockstill on DSK3G9T082PROD with RULES2 SUMMARY: Acronyms AAAHC Accreditation Association for Ambulatory Health Care, Inc. AAAASF American Association for Accreditation for Ambulatory Surgery Facilities, Inc. VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 AAR/IP After Action Report/Improvement Plan ACHC Accreditation Commission for Health Care, Inc. ACHE American College of Healthcare Executives AHA American Hospital Association AO Accrediting Organization AOA/HFAP American Osteopathic Association/Healthcare Facilities Accreditation Program ASC Ambulatory Surgical Center ARCAH Accreditation Requirements for Critical Access Hospitals ASPR Assistant Secretary for Preparedness and Response BLS Bureau of Labor Statistics BTCDP Bioterrorism Training and Curriculum Development Program CAH Critical Access Hospital CAMCAH Comprehensive Accreditation Manual for Critical Access Hospitals CAMH Comprehensive Accreditation Manual for Hospitals CASPER Certification and the Survey Provider Enhanced Reporting CDC Centers for Disease Control and Prevention CON Certificate of Need CfCs Conditions for Coverage and Conditions for Certification CHAP Community Health Accreditation Program CMHC Community Mental Health Center CMS Centers for Medicare and Medicaid Services COI Collection of Information CoPs Conditions of Participation CORF Comprehensive Outpatient Rehabilitation Facilities CPHP Centers for Public Health Preparedness CRI Cities Readiness Initiative DHS Department of Homeland Security DHHS Department of Health and Human Services DNV GL Det Norske Veritas GL—Healthcare DOL Department of Labor DPU Distinct Part Units DSA Donation Service Area EOP Emergency Operations Plans EC Environment of Care EMP Emergency Management Plan EP Emergency Preparedness ESAR–VHP Emergency System for Advance Registration of Volunteer Health Professionals ESF Emergency Support Function ESRD End-Stage Renal Disease FEMA Federal Emergency Management Agency FDA Food and Drug Administration FORHP Federal Office of Rural Health Policy FRI Federal Reserve Inventories FQHC Federally Qualified Health Center GAO Government Accountability Office HFAP Healthcare Facilities Accreditation Program HHA Home Health Agencies HPP Hospital Preparedness Program HRSA Health Resources and Services Administration HSC Homeland Security Council HSEEP Homeland Security Exercise and Evaluation Program PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 HSPD Homeland Security Presidential Directive HVA Hazard Vulnerability Analysis or Assessment ICFs/IID Intermediate Care Facilities for Individuals with Intellectual Disabilities ICR Information Collection Requirements IDG Interdisciplinary Group IOM Institute of Medicine JPATS Joint Patient Assessment and Tracking System LEP Limited English Proficiency LD Leadership LPHA Local Public Health Agencies LSC Life Safety Code LTC Long Term Care MMRS Metropolitan Medical Response System MRC Medical Reserve Corps MS Medical Staff NDMS National Disaster Medical System NFs Nursing Facilities NFPA National Fire Protection Association NIMS National Incident Management System NIOSH National Institute for Occupational Safety and Health NLTN National Laboratory Training Network NRP National Response Plan NRF National Response Framework NSS National Security Staff OBRA Omnibus Budget Reconciliation Act OIG Office of the Inspector General OPHPR Office of Public Health Preparedness and Response OPO Organ Procurement Organization OPT Outpatient Physical Therapy OPTN Organ Procurement and Transplantation Network OSHA Occupational Safety and Health Administration PACE Program for the All-Inclusive Care for the Elderly PAHPA Pandemic and All-Hazards Preparedness Act PAHPRA Pandemic and All-Hazards Preparedness Reauthorization Act PCT Patient Care Technician PPE Personal Protection Equipment PHEP Public Health Emergency Preparedness PHS Act Public Health Service Act PIN Policy Information Notice PPD Presidential Policy Directive PRTF Psychiatric Residential Treatment Facilities QAPI Quality Assessment and Performance Improvement QIES Quality Improvement and Evaluation System RFA Regulatory Flexibility Act RNHCIs Religious Nonmedical Health Care Institutions RHC Rural Health Clinic SAMHSA Substance Abuse and Mental Health Services Administration SLP Speech Language Pathology SNF Skilled Nursing Facility SNS Strategic National Stockpile TEFRA Tax Equity and Fiscal Responsibility Act TFAH Trust for America’s Health TJC The Joint Commission TRACIE Technical Resources, Assistance Center, and Information Exchange E:\FR\FM\16SER2.SGM 16SER2 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations TTX Tabletop Exercise UMRA Unfunded Mandates Reform Act UNOS United Network for Organ Sharing UPMC University of Pittsburgh Medical Center WHO World Health Organization mstockstill on DSK3G9T082PROD with RULES2 Table of Contents I. Overview A. Executive Summary 1. Purpose 2. Summary of the Major Provisions B. Current State of Emergency Preparedness C. Statutory and Regulatory Background II. Provisions of the Proposed Rule and Responses to Public Comments A. General Comments 1. Integrated Health Systems 2. Requests for Technical Assistance and Funding 3. Requirement To Track Patients and Staff B. Implementation Date C. Emergency Preparedness Regulations for Hospitals (§ 482.15) 1. Risk Assessment and Emergency Plan (§ 482.15(a)) 2. Policies and Procedures (§ 482.15(b) 3. Communication Plan (§ 482.15(c) 4. Training and Testing (§ 482.15(d) 5. Emergency Fuel and Generator Testing (§ 482.15(e) D. Emergency Preparedness Regulations for Religious Nonmedical Health Care Institutions (RNHCIs) (§ 403.748) E. Emergency Preparedness Regulations for Ambulatory Surgical Centers (ASCs) (§ 416.54) F. Emergency Preparedness Regulations for Hospices (§ 418.113) G. Emergency Preparedness Regulations for Psychiatric Residential Treatment Facilities (PRTFs) (§ 441.184) H. Emergency Preparedness Regulations for Programs of All-Inclusive Care for the Elderly (PACE) (§ 460.84) I. Emergency Preparedness Regulations for Transplant Centers (§ 482.78) J. Emergency Preparedness Regulations for Long-Term Care (LTC) Facilities (§ 483.73) K. Emergency Preparedness Regulations for Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICF/IID) (§ 483.475) L. Emergency Preparedness Regulations for Home Health Agencies (HHAs) (§ 484.22) M. Emergency Preparedness Regulations for Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§ 485.68) N. Emergency Preparedness Regulations for Critical Access Hospitals (CAHs) (§ 485.625) O. Emergency Preparedness Regulations for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (Organizations) (§ 485.727) P. Emergency Preparedness Regulations for Community Mental Health Centers (CMHCs) (§ 485.920) Q. Emergency Preparedness Regulations for Organ Procurement Organizations (OPOs) (§ 486.360) VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 R. Emergency Preparedness Regulations for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (§ 491.12) S. Emergency Preparedness Regulations for End-Stage Renal Disease (ESRD) Facilities (§ 494.62) III. Provisions of the Final Regulations A. Changes Included in the Final Rule B. Incorporation by Reference IV. Collection of Information V. Regulatory Impact Analysis VI. Waiver of Proposed Rulemaking I. Overview A. Executive Summary 1. Purpose We have reviewed existing Medicare emergency regulatory preparedness requirements for both providers and suppliers. We found that many providers and suppliers have emergency preparedness requirements, but those requirements do not go far enough in ensuring that these providers and suppliers are equipped and prepared to help protect those they serve during emergencies and disasters. Hospitals, for example, are currently required to have emergency power and lighting in some specified areas and there must be facilities for emergency gas and water supply. We believe that these existing requirements are generally insufficient in the face of the needs of the patients, staff and communities, and do not address inconsistency in the level of emergency preparedness amongst healthcare providers. For example, while some accreditation organizations have standards that exceed CMS’ current requirements for hospitals by requiring them to conduct a risk assessment, there are other providers and suppliers who do not have any emergency preparedness requirements, such as Community Mental Health Centers (CMHCs) and Psychiatric Residential Treatment Facilities (PRTFs). We concluded that current emergency preparedness requirements are not comprehensive enough to address the complexities of the actual emergencies. Over the past several years, the United States has been challenged by several natural and manmade disasters. As a result of the September 11, 2001 terrorist attacks, the subsequent anthrax attacks, the catastrophic hurricanes in the Gulf Coast states in 2005, flooding in the Midwestern states in 2008, the 2009 H1N1 influenza pandemic, tornadoes and floods in the spring of 2011, and Hurricane Sandy in 2012, our nation’s health security and readiness for public health emergencies have been on the national agenda. This final rule issues emergency preparedness requirements PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 63861 that establish a comprehensive, consistent, flexible, and dynamic regulatory approach to emergency preparedness and response that incorporates the lessons learned from the past, combined with the proven best practices of the present. We recognize that central to this approach is to develop and guide emergency preparedness and response within the framework of our national healthcare system. To this end, these requirements also encourage providers and suppliers to coordinate their preparedness efforts within their own communities and states as well as across state lines, as necessary, to achieve their goals. 2. Summary of the Major Provisions We are issuing emergency preparedness requirements that will be consistent and enforceable for all affected Medicare and Medicaid providers and suppliers (referred to collectively as ‘‘facilities,’’ throughout the remainder of this final rule where applicable). This final rule addresses the three key essentials we believe are necessary for maintaining access to healthcare services during emergencies: safeguarding human resources, maintaining business continuity, and protecting physical resources. Current regulations for Medicare and Medicaid providers and suppliers do not adequately address these key elements. Based on our research and consultation with stakeholders, we have identified four core elements that are central to an effective and comprehensive framework of emergency preparedness requirements for the various Medicare- and Medicaidparticipating providers and suppliers. The four elements of the emergency preparedness program are as follows: • Risk assessment and emergency planning: We are requiring facilities to perform a risk assessment that uses an ‘‘all-hazards’’ approach prior to establishing an emergency plan. The allhazards risk assessment will be used to identify the essential components to be integrated into the facility emergency plan. An all-hazards approach is an integrated approach to emergency preparedness planning that focuses on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters. This approach is specific to the location of the provider or supplier and considers the particular types of hazards most likely to occur in their areas. These may include, but are not limited to, care-related emergencies; equipment and power failures; interruptions in communications, including cyberattacks; loss of a portion or all of a E:\FR\FM\16SER2.SGM 16SER2 mstockstill on DSK3G9T082PROD with RULES2 63862 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations facility; and, interruptions in the normal supply of essentials, such as water and food. Additional information on the emergency preparedness cycle can be found at the Federal Emergency Management Agency (FEMA) National Preparedness System Web site located at: https://www.fema.gov/threat-andhazard-identification-and-riskassessment. • Policies and procedures: We are requiring that facilities develop and implement policies and procedures that support the successful execution of the emergency plan and risks identified during the risk assessment process. • Communication plan: We are requiring facilities to develop and maintain an emergency preparedness communication plan that complies with both federal and state law. Patient care must be well-coordinated within the facility, across healthcare providers, and with state and local public health departments and emergency management agencies and systems to protect patient health and safety in the event of a disaster. The following link is to FEMA’s comprehensive preparedness guide to develop and maintain emergency operations plans: https://www.fema.gov/media-librarydata/20130726-1828-25045-0014/ cpg_101_comprehensive_preparedness _guide_developing_and_maintaining _emergency_operations_plans_2010.pdf. During an emergency, it is critical that hospitals, and all providers/suppliers, have a system to contact appropriate staff, patients’ treating physicians, and other necessary persons in a timely manner to ensure continuation of patient care functions throughout the facilities and to ensure that these functions are carried out in a safe and effective manner. • Training and testing: We are requiring that a facility develop and maintain an emergency preparedness training and testing program. A wellorganized, effective training program must include initial training for new and existing staff in emergency preparedness policies and procedures as well as annual refresher trainings. The facility must offer annual emergency preparedness training so that staff can demonstrate knowledge of emergency procedures. The facility must also conduct drills and exercises to test the emergency plan to identify gaps and areas for improvement. The Homeland Security Exercise and Evaluation Program (HSEEP), developed by FEMA, includes a section on the establishment of a Training and Exercise Planning Workshop (TEPW). The TEPW section provides guidance to organizations in conducting an annual TEPW and VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 developing a Multi-year Training and Exercise Plan (TEP) in line with the (HSEEP): http://www.fema.gov/medialibrary-data/20130726-1914-250458890/hseep_apr13_.pdf. Medicare and Medicaid participating hospitals and other providers and suppliers through the conditions of participation (CoPs) and conditions for coverage (CfCs) established by this rule. B. Current State of Emergency Preparedness As previously discussed, numerous natural and man-made disasters have challenged the United States over the past several years. Disasters can disrupt the environment of healthcare and change the demand for healthcare services; therefore, it is essential that healthcare facilities integrate emergency management into their daily functions and values. On December 27, 2013, we published a proposed rule titled, ‘‘Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers’’ (78 FR 79082). In this proposed rule we included a robust discussion about the current state of emergency preparedness and federal emergency preparedness activities that have established a foundation for the development and expansion of healthcare emergency preparedness systems. In addition, the December 2013 proposed rule included an appendix of the numerous resources and documents used to develop the proposed rule. We refer readers to the proposed rule for this background information. The December 2013 proposed rule included discussion of previous events, such as the 2009 H1N1 influenza pandemic, the 2001 anthrax attacks, the tornados in 2011 and 2012, and Hurricane Sandy in 2012. In 2014, the United States faced a number of new and emerging diseases, such as MERSCoV and Ebola, and a nationwide outbreak of Enterovirus D68, which was confirmed in 938 people in 46 states between mid-August and October 21, 2014 (http://www.cdc.gov/non-polioenterovirus/outbreaks/EV-D68outbreaks.html). We believe that finalizing the emergency preparedness rule is an important part of improving the national response to Ebola and any infectious disease threats. Healthcare providers have raised concerns about their safety when caring for patients with Ebola, citing the need for advanced preparation, effective policies and procedures, communication plans, and sufficient training and testing, particularly for personal protection equipment (PPE). The response highlighted the importance of establishing written procedures, protocols, and policies ahead of an emergency event. With the finalization of the emergency preparedness rule, this type of planning will be mandated for C. Statutory and Regulatory Background Various sections of the Social Security Act (the Act) define the types of providers and suppliers that may participate in Medicare and Medicaid and list the requirements that each provider and supplier must meet to be eligible for Medicare and Medicaid participation. The Act also authorizes the Secretary to establish other requirements as necessary to protect the health and safety of patients, although the wording of such authority differs slightly between provider and supplier types. Such requirements may include the CoPs for providers, CfCs for suppliers, and requirements for longterm care facilities. The CoPs and CfCs are intended to protect public health and safety and promote high quality care for all persons. Furthermore, the Public Health Service (PHS) Act sets forth additional regulatory requirements that certain Medicare providers and suppliers are required to meet in order to participate. The following are the statutory and regulatory citations for the providers and suppliers for which we are issuing emergency preparedness regulations: • Religious Nonmedical Health Care Institutions (RNHCIs)—section 1821 of the Act and 42 CFR 403.700 through 403.756. • Ambulatory Surgical Centers (ASCs)—section 1832(a)(2)(F)(i) of the Act and 42 CFR 416.2 and 416.40 through 416.52. • Hospices—section 1861(dd)(1) of the Act and 42 CFR 418.52 through 418.116. • Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Residential Treatment Facilities (PRTFs)—sections1905(a) and 1905(h) of the Act and 42 CFR 441.150 through 441.182 and 42 CFR 483.350 through 483.376. • Programs of All-Inclusive Care for the Elderly (PACE)—sections 1894, 1905(a), and 1934 of the Act and 42 CFR 460.2 through 460.210. • Hospitals—section 1861(e)(9) of the Act and 42 CFR 482.1 through 482.66. • Transplant Centers—sections 1861(e)(9) and 1881(b)(1) of the Act and 42 CFR 482.68 through 482.104. • Long Term Care (LTC) Facilities— Skilled Nursing Facilities (SNFs)— under section 1819 of the Act, Nursing Facilities (NFs)—under section 1919 of the Act, and 42 CFR 483.1 through 483.180. PO 00000 Frm 00004 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 • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID)—section 1905(d) of the Act and 42 CFR 483.400 through 483.480. • Home Health Agencies (HHAs)— sections 1861(o), 1891 of the Act and 42 CFR 484.1 through 484.55. • Comprehensive Outpatient Rehabilitation Facilities (CORFs)— section 1861(cc)(2) of the Act and 42 CFR 485.50 through 485.74. • Critical Access Hospitals (CAHs)— sections 1820 and 1861(mm) of the Act and 42 CFR 485.601 through 485.647. • Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services— section 1861(p) of the Act and 42 CFR 485.701 through 485.729. • Community Mental Health Centers (CMHCs)—section 1861(ff)(3)(B)(i)(ii) of the Act, section 1913(c)(1) of the PHS Act, and 42 CFR 410.110. • Organ Procurement Organizations (OPOs)—section 1138 of the Act and section 371 of the PHS Act and 42 CFR 486.301 through 486.348. • Rural Health Clinics (RHCs)— section 1861(aa) of the Act and 42 CFR 491.1 through 491.11; Federally Qualified Health Centers (FQHCs)— section 1861(aa) of the Act and 42 CFR 491.1 through 491.11, except 491.3. • End-Stage Renal Disease (ESRD) Facilities—sections 1881(b), 1881(c), 1881(f)(7) of the Act and 42 CFR 494.1 through 494.180. The proposed rule responded to concerns from the Congress, the healthcare community, and the public regarding the ability of healthcare facilities to plan and execute appropriate emergency response procedures for disasters. In the proposed rule, we identified four core elements that we believe are central to an effective emergency preparedness system and must be addressed to offer a more comprehensive framework of emergency preparedness requirements for the various Medicare- and Medicaidparticipating providers and suppliers. The four elements are—(1) risk assessment and emergency planning; (2) policies and procedures; (3) communication plan; and (4) training and testing. We proposed that these core components be used across provider and supplier types as diverse as hospitals, organ procurement organizations, and home health agencies, while attempting to tailor requirements for individual provider and supplier types to meet their specific needs and circumstances, as well as the needs of their patients, residents, clients, and participants. These VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 proposals are refined and adopted in this final rule. II. Provisions of the Proposed Rule and Responses to Public Comments In response to our December 2013 proposed rule, we received nearly 400 public comments. Commenters included individuals, healthcare professionals and corporations, national associations, health departments and emergency management professionals, and individual facilities that would be impacted by the regulation. Most comments centered around the hospital requirements, but could be applied to the additional provider and supplier types. We also received comments specific to the requirements we proposed for other individual provider and supplier types. In addition, we solicited comments on specific issues. We have organized our responses to the comments as follows: (1) General comments; (2) implementation date; (3) comments specific to hospitals and those that apply to the overall requirements of the regulation; and (4) comments specific to other providers and suppliers. A. General Comments We received the following comments suggesting improvement to our regulatory approach or requesting clarification of the resources used to develop our proposals: Comment: Most commenters supported our proposal to require Medicare and Medicaid participating facilities to establish an emergency preparedness plan. Many of these commenters noted that this proposal is timely and necessary in light of past emergencies and natural disasters. Response: We thank the commenters for their support. We continue to believe that our current regulations for Medicare and Medicaid providers and suppliers do not adequately address emergency preparedness planning and that emergency preparedness CoPs for providers and CfCs for suppliers should be implemented at this time. Comment: Several commenters disagreed with our proposal to establish emergency preparedness requirements for Medicare and Medicaid providers and suppliers. Some commenters were concerned that this proposal would place undue burden and financial strain on facilities. Most of these commenters stated that it would be difficult to implement additional regulations without additional payment through Medicare, Medicaid, or the Hospital Preparedness Program (HPP). The commenters also stated that facilities PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 63863 would need more time to comply with the proposed requirements. A few commenters disagreed with our statement that hospitals should have emergency preparedness plans and stated that hospitals are already prepared for emergencies. A commenter objected to the statement that hospital leadership has not prioritized disaster preparedness. A commenter recommended that the proposed emergency preparedness requirements be reduced and simplified to reflect the minimum requirements that each provider type is expected to meet. Other commenters objected to the entire proposal and the establishment of additional regulations for healthcare facilities. Response: We disagree with the commenters who stated that the emergency preparedness regulations are inappropriate or unnecessary. Healthcare facilities in the United States have faced many challenges over the years including hurricanes, tornados, floods, wild fires, and pandemics. Facilities that do not have plans established prior to an emergency or a disaster may face difficulties providing continuity of care for their patients. In addition, without proper training, healthcare workers may find it difficult to implement emergency preparedness plans during an emergency or a disaster. Upon review of the current emergency preparedness requirements for providers and suppliers participating in Medicare and Medicaid, we concluded that the current requirements are not comprehensive enough to address the complexities of actual emergencies. We believe that, currently, in the event of a disaster, healthcare facilities across the nation will not have the necessary emergency planning and preparation in place to adequately protect the health and safety of their patients. In addition, we believe that the current regulatory patchwork of federal, state, and local laws and guidelines, combined with various accrediting organizations’ emergency preparedness standards, falls far short of what is needed for healthcare facilities to be adequately prepared for a disaster. Therefore, we proposed to establish comprehensive, consistent, and flexible emergency preparedness regulations that incorporate lessons learned from the past with the proven best practices of the present. Finalizing these proposals, with the modifications discussed later in this final rule, will help healthcare facilities be better prepared in case of a disaster or emergency. We note that the majority of the comments to the proposed rule agree with the establishment of some type of regulatory E:\FR\FM\16SER2.SGM 16SER2 mstockstill on DSK3G9T082PROD with RULES2 63864 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations framework for emergency preparedness planning, which further supports our position that establishing emergency preparedness regulations is the most appropriate course of action. In response to comments that request additional time for compliance or additional funds, we refer readers to the discussion on the implementation date and further discussions on funding in this final rule. Comment: Some commenters stated that the term ‘‘ensure’’ was used numerous times in the proposed rule and that the term was over-used. Commenters stated that in some circumstances we stated providers and suppliers had to ‘‘ensure’’ elements of the plan that might be beyond their control during an emergency. A commenter suggested that we replace the word ‘‘ensure’’ with the term ‘‘strive to achieve.’’ Response: We used the word ‘‘ensure’’ or ‘‘ensuring’’ to convey that each provider and supplier will be held accountable for complying with the requirements in this rule. However, to avoid any ambiguity, we have removed the term ‘‘ensure’’ and ‘‘ensuring’’ from the regulation text of all providers and suppliers and have addressed the requirements in a more direct manner. Comment: Some commenters were concerned that the proposed emergency preparedness requirements duplicate existing requirements by The Joint Commission (TJC). TJC is a CMSapproved accrediting organization that has standards and survey procedures that meet or exceed those used by CMS and state surveyors. Facilities accredited under a Medicare approved accreditation program, such as TJC’s, may be ‘‘deemed’’ by CMS to be in compliance with the CoPs. Most of these commenters recommended that CMS rely on existing TJC standards. Other commenters noted that CMS used TJC manual citations from 2007 through 2008. The commenters noted that changes have been made since then and recommended that CMS refer to the most recent TJC manual. Response: We discussed TJC standards in the proposed rule as a point of reference for emergency preparedness standards that currently exist for healthcare facilities, absent additional federal regulations. We note that CMS has the authority to create and modify CoPs, which establish the requirements a provider must meet to participate in the Medicare or Medicaid program. Also, we note that facilities that exceed CMS’s requirements will still remain compliant. Comment: A few commenters stated that the proposal did not take into VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 account the differences that exist between individual facilities. The commenters noted that the proposal does not acknowledge the diversity of different facilities and instead requires a ‘‘one size fits all’’ emergency preparedness plan. The commenters recommended that CMS address the variation between facilities in the emergency preparedness requirements. Some commenters stated that the proposed requirements are inappropriate because they mostly apply to hospitals, and cannot be applied to other healthcare settings. A commenter noted that smaller hospitals with limited capabilities, like LTCHs, should be allowed to work with their local emergency response networks to develop emergency preparedness plans that reflect those hospitals’ limitations. Response: We believe our approach, with the changes to our proposal discussed later in this final rule, appropriately addresses the differences between the 17 provider and supplier types covered by these regulations. We believe that emergency preparedness regulations that are too specific may become outdated over time, as technology and the nature of threats change, and that emergency preparedness regulations that are too broad may be ineffective. Therefore, we proposed four main components that are consistent with the principles as set forth in the National Preparedness Cycle contained within the National Preparedness System (link (see: https:// www.fema.gov/national-preparednesssystem) that can be used across diverse healthcare settings, while tailoring specific requirements for individual provider and supplier types based on their needs and circumstances, as well as the needs and circumstances of their patients, residents, clients, and participants. We continue to believe that these four components, and the variations in the specific requirements of these components, appropriately address variation amongst provider and supplier settings and facilities with an appropriate amount of flexibility. We do not believe that we have taken a ‘‘one size fits all’’ approach in these regulations. We agree with the commenter who stated that smaller hospitals should be allowed to work with their local health department and emergency management agency to develop emergency preparedness plans and we encourage these facilities to engage in healthcare coalitions in their area for assistance in meeting these requirements. However, we note that we are not mandating that smaller facilities confer with local emergency response networks while PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 developing their emergency preparedness plans. Comment: A few commenters stated that the proposed provisions were too specific and detailed. Some commenters believed that, like other CoPs, the proposal should include provisions that are more flexible. The commenters noted that more specificity should be included in CMS’ interpretive guidance documents (IGs). Response: We disagree with commenters. We believe that these regulations strike a balance between the specific and the general. We have not prescribed or mandated specific technology or tools, nor have we included detailed requirements for how emergency preparedness plans should be written. The regulations are broad enough that facilities can formulate an effective emergency preparedness plan, based on a facility-based and community-based risk assessment utilizing an all-hazards approach, that includes appropriate policies and procedures, a communication plan, and training and testing. In meeting the emergency preparedness requirements, providers can tailor specific details to their facilities’ and their patients’ needs. Facilities can also exceed the requirements in this final rule, if they believe it is in their patients’ and their facilities’ interests to do so. Comment: A few commenters suggested that CMS require facilities to include other entities, stakeholders, and individuals in their emergency preparedness planning. Specifically, a few commenters suggested that facilities include patients, their family members, and vulnerable populations, including older adults, people with disabilities, and those who are linguistically isolated, in their emergency preparedness planning. A few commenters also recommended that facilities include patients and their families in emergency preparedness education. A few commenters recommended that front line workers and their workers’ unions be included in the emergency preparedness planning. A commenter suggested that CMS emphasize the full continuum of emergency management activities and identify relevant national associations and resources for each provider type. A commenter noted that local emergency management officials are rarely included in emergency planning. The commenter recommended adding a requirement that would require facilities to submit their emergency preparedness plan to their local emergency management agency for review and assessment, and for assistance on sheltering and evacuation procedures. E:\FR\FM\16SER2.SGM 16SER2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations Response: In the proposed rule, we proposed to require certain facilities to develop a method for sharing information from the emergency plan that the facility determines is appropriate with patients/residents and their families or representatives. A facility may choose to involve other entities in the development of an emergency preparedness plan or they can provide emergency preparedness education to patients’ families and caregivers. During the development of the emergency plan, facilities may also choose to include patients, community members and others in the process. However, we are not mandating these actions as we believe such a requirement would impose an excessive burden on providers and suppliers; instead, we encourage and will allow facilities the discretion to confer with entities and resources that they consider appropriate while creating an emergency preparedness plan and strongly encourage that facilities include individuals with disabilities and others with access and functional needs in their planning. Comment: A commenter recommended that emergency preparedness plans should account for children’s special needs during an emergency. The commenter stated that emergency preparedness plans should include children’s medication and medical device needs, challenges regarding patient transfer for neonatal and pediatric intensive care patients, and issues involving behavioral health and family reunification. A commenter recommended that CMS collaborate closely with the Emergency Medical Services for Children (EMSC) program administered by the Health Resources and Services Administration (HRSA). The commenter noted that this program focuses on improving the pediatric components of the EMS system. Response: We appreciate the commenter’s concerns. As required in § 482.15(a)(1), (2), and (3), when a provider or supplier develops an emergency preparedness plan, we will expect that the provider/supplier will use a facility-based and communitybased risk assessment to develop a plan that addresses that facility’s patient population, including at-risk populations. If the provider serves children, or if the majority of its patient population is children, as is the case for children’s hospitals, we will expect the provider to take into account children’s access and functional needs during an emergency or disaster in its emergency preparedness plan. VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 Comment: A few commenters questioned CMS’ definition of an emergency. A commenter disagreed with the proposed rule’s definition of ‘‘emergency’’ and ‘‘disaster.’’ The commenter stated that the proposed rule definitions exclude internal or smaller disasters that a hospital may declare. Furthermore, the commenter noted that the definitions should include mass casualty incidents and internal emergencies or disasters that a facility may declare. Another commenter requested clarification as to whether the regulation applies to external or internal emergencies. Response: In the proposed rule, we defined an ‘‘emergency’’ or ‘‘disaster’’ as an event affecting the overall target population or the community at large that precipitates the declaration of a state of emergency at a local, state, regional, or national level by an authorized public official such as a Governor, the Secretary of the Department of Health and Human Services (HHS), or the President of the United States. However, we agree with the commenter’s observation that the definition of an ‘‘emergency’’ or ‘‘disaster’’ should include internal emergency or disaster events. Therefore, we clarify our statement that an ‘‘emergency’’ or ‘‘disaster’’ is an event that can affect the facility internally as well as the overall target population or the community at large. We believe that hospitals should have a single emergency plan that addresses all-hazards, including internal emergencies and a man-made emergency (or both) or natural disaster. Hospitals have the discretion to determine when to activate their emergency plan and whether to apply their emergency plan to internal or smaller emergencies or disasters that may occur within their facilities. We encourage hospitals to prepare for allhazards that may affect their patient population and apply their emergency preparedness plans to any emergency or disaster that may arise. Furthermore, we encourage hospitals that may be dealing with an internal emergency or disaster to maintain communication with external emergency preparedness entities and other facilities where appropriate. Comment: A few commenters were concerned that the proposed rule did not require planning for recovery of operations. The commenters recommended that CMS include requirements for facilities to plan for the return of normal operations after an emergency. A commenter recommended that CMS include requirements for provider preparedness in case of an PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 63865 information technology (IT) system failure. Response: We understand the commenter’s concerns and believe that facilities should consider planning for recovery of operations during the emergency or disaster response. Recovery of operations will require that facilities coordinate efforts with the relevant health department and emergency management agencies to restore facilities to their previous state prior to the emergency or disaster event. Our new emergency preparedness requirements focus on continuity of operations, not recovery of operations. Facilities can choose to include recovery of operations planning in their emergency preparedness plan, but we have not made recovery of operations planning a requirement. We refer commenters that are interested in recovery of operations planning to the following resources for more information: • National Disaster Recovery Framework (NDRF): https:// www.fema.gov/national-disasterrecovery-framework. • Continuity Guidance Circular 1 (CGC 1), and Continuity Guidance for Non-Federal Entities (States, Territories, Tribal, and Local Government Jurisdictions and Private Sector Organizations) http://www.fema.gov/ pdf/about/org/ncp/cont_guidance1.pdf. • National Preparedness System (https://www.fema.gov/nationalpreparedness-system) • Comprehensive Preparedness Guide 101 http://www.fema.gov/media-librarydata/20130726-1828-25045-0014/ cpg_101_comprehensive_preparedness_ guide_developing_and_maintaining _emergency_operations_ plans_2010.pdf) Comment: A commenter requested clarification on whether hospitals would have direct access to the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR–VHP). A commenter recommended that CMS work with other federal agencies, including the Department of Homeland Security (DHS) and the Federal Emergency Management Agency (FEMA) to expand ESAR–VHP and Medical Reserve Corps (MRC) team deployments to a 3 month rotation basis. The commenter also recommended that CMS purchase and pre-position Federal Reserve Inventories (FRI) at healthcare distributorships. Response: Hospitals do not have direct access to the Emergency System for Advance Registration of Volunteer Health Professional (ESAR–VHP). The Assistant Secretary for Preparedness E:\FR\FM\16SER2.SGM 16SER2 mstockstill on DSK3G9T082PROD with RULES2 63866 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations and Response (ASPR) manages the ESAR–VHP program. The program is administered on the state level. A hospital would request volunteer health professionals through State Emergency Management. For more information, reviewers may email ASPR at esarvhp@hhs.gov or visit the ESAR/VHP Web site: http://www.phe.gov/esarvhp/ pages/home.aspx. Volunteer deployments typically last for 2 weeks and are not extended without the agreement of the volunteer. In regards to the comment on the Federal Reserve Inventories, we believe that the commenter may be referring to the Strategic National Stockpile (SNS). The SNS program is a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications, and medical supplies. It is not within CMS’ purview to purchase, administer, or maintain SNS stock. We refer commenters who have questions about the SNS program to the Centers for Disease Control and Prevention (CDC) Web site at http:// emergency.cdc.gov/stockpile/index.asp. Comment: A commenter noted that CMS did not include emergency preparedness requirements for transport units (fire and rescue units, and ambulances). Furthermore, the commenter questioned whether a Certificate of Need (CON) is necessary during an emergency. Another commenter questioned why large single specialty and multispecialty medical groups are not discussed as included or excluded in this rule. The commenter noted that these entities have Medicare and Medicaid provider status; therefore, should be included in this rule. Another commenter questioned whether the proposed regulations would apply to residential drug and alcohol treatment centers. The commenter noted that if this is the case, it would be difficult for these centers to meet the proposed requirements due to lack of funding. Response: The emergency preparedness requirements only pertain to the 17 provider and supplier types discussed previously in this rule, which have existing CoPs or CfCs. These provider and supplier types do not include fire and rescue units, and ambulances, or single-specialty/multispecialty medical groups. Entities that work with hospitals or any of the other provider and supplier types covered by this regulation may have a role in the provider’s or supplier’s emergency preparedness plan, and providers or suppliers may choose to consider the role of these entities in their emergency preparedness plan. In addition, we note that CMS does not exercise regulatory VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 authority over drug and alcohol treatment centers. In response to the question about a Certificate of Need, we note that facilities must formulate an emergency preparedness plan that complies with state and local laws. A Certificate of Need is a document that is needed in some states and local jurisdiction before the creation, acquisition, or expansion of a facility is allowed. Facilities should check with their state and local authorities in regards to Certificate of Need requirements. Comment: A commenter requested clarification on a facility’s responsibility to patients that have already evacuated the facility on their own. Response: Facilities are required to track the location of staff and patients in the facility’s care during an emergency. The facility is not required to track the location of patients who have voluntarily left on their own, since they are no longer in the facility’s care. However, if a patient voluntarily leaves a facility’s care during an emergency or a disaster, the facility may choose to inform the appropriate health department and emergency management or emergency medical services authorities if it believes the patient may be in danger. Comment: A commenter questioned whether the requirements take into account the role of the physician during emergency preparedness planning. The commenter questioned whether physicians will be required to provide feedback during the planning process, whether physicians would have a role in preserving patient medical documentation, whether physicians would be involved in determining arrangements for patients during a cessation of operations, and to what extent physicians would be required to participate in training and testing. Response: Individual physicians are not required, but are encouraged, to develop and maintain emergency preparedness plans. However, physicians that work in a facility that is required to develop and maintain an emergency preparedness plan can and are encouraged to provide feedback or suggestions for best practices. In addition, physicians that are employed by the facility and all new and existing staff must participate in emergency preparedness training and testing. We have not mandated a specific role for physicians during an emergency or disaster event, but we expect facilities to delineate responsibilities for all of their facility’s workers in their emergency preparedness plans and to determine the appropriate level of training for each professional role. PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 Comment: A commenter objected to use of the term ‘‘volunteers’’ in the proposed rule. The commenter stated that this term was not defined and recommended that the proposal be limited to healthcare professionals used to address surge needs during an emergency. Another commenter recommended that the regulation text should be revised to include the language, ‘‘Use of health care volunteers’’, to further clarify this distinction. Response: We provided information on the use of volunteers in the proposed rule (78 FR 79097), specifically with reference to the Medical Reserve Corps and the ESAR–VHP programs. Private citizens or medical professionals not employed by a hospital or facility often offer their voluntary services to hospitals or other entities during an emergency or disaster event. Therefore, we believe that facilities should have policies and procedures in place to address the use of volunteers in an emergency, among other emergency staffing strategies. We believe such policies should address, among other things, the process and role for integration of healthcare professionals that are locally-designated, such as the Medical Reserve Corps (https:// www.medicalreservecorps.gov/Home Page), or state-designated, such as Emergency System for Advance Registration of Volunteer Health Professional (ESAR–VHP), (http:// www.phe.gov/esarvhp/pages/ home.aspx) that have assisted in addressing surge needs during prior emergencies. As with previous emergencies, facilities may choose to utilize assistance from the MRC or through the state ESAR–VHP program. We believe the description of healthcare volunteers is already included in the current requirement and does not need to be further defined. Comment: A commenter questioned if the proposal will require facilities to plan for an electromagnetic event. The commenter noted that protecting against and treating patients after an electromagnetic event is costly. Another commenter recommended that the rule explicitly include and address the threats of fire, wildfires, tornados, and flooding. The commenter notes that these scenarios are not included in the National Planning Scenarios (NPS). Response: We expect facilities to develop an emergency preparedness plan that is based on a facility-based and community-based risk assessment using an ‘‘all-hazards’’ approach. If a provider or supplier determines that its facility or community is at risk for an E:\FR\FM\16SER2.SGM 16SER2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations electromagnetic event or natural disasters, such as fires, wildfires, tornados, and flooding, the provider or supplier can choose to incorporate planning for such an event into its emergency preparedness plan. We note that compliance with these requirements, including a determination of whether the provider or supplier based its emergency preparedness plan on facility-based and community-based risk assessments using an all-hazards approach, will be assessed through onsite surveys by CMS, State Survey Agencies, or Accreditation Organizations with CMS-approved accreditation programs. Comment: A few commenters had recommendations for the structure and organization of the proposed rule. A commenter recommended that CMS specify the 17 providers and supplier types to which the rule would apply in the first part of the rule, so that facilities could verify whether or not the regulations would apply to them. A few commenters suggested that the requirements of the proposed rule should not be included in the CoPs, but instead comprise a separate regulatory chapter specific to emergency preparedness. Response: We included a list of the provider and supplier types affected by the emergency preparedness requirements in the proposed rule’s Table of Contents (78 FR 79083 through 79084) and in the preamble text 78 FR 79090. Thus, we believe that we clearly listed the affected providers and suppliers at the very beginning of the proposed rule. We also believe the emergency preparedness requirements should be included in the CoPs for providers, the CfCs for suppliers, and requirements for LTC facilities. These CoPs, CfCs, and requirements for LTC facilities are intended to protect public health and safety and ensure that high quality care is provided to all persons. Facilities must meet their respective CoPs, CfCs, or requirements in order to participate in the Medicare and Medicaid programs. We are able to enforce and monitor compliance with the CoPs, CfCs, and requirements for LTC facilities through the survey process. Therefore, we believe that the emergency preparedness requirements are included in the most appropriate regulatory chapters. Comment: A few commenters suggested additional citations for the proposed rule, recommended that we include specific reference material, and suggested edits to the preamble language. A commenter stated that we omitted some references in the preamble discussion of the proposed rule. The VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 commenter noted that while we included references to HSPD 5, 21, and 8 in the proposed rule, the commenter recommended that all of the HSPDs should have been included. Furthermore, the commenter noted that HSPD 7 in particular, which does not provide a specific role for HHS, should have been referenced since it includes discussion of critical infrastructure protection and the role it plays in allhazards mitigation. A commenter suggested that we add the following text to section II.B.1.a. of the proposed rule (78 FR 79085): ‘‘HSPD–21 tasked the establishment of the National Center for Disaster Medicine and Public Health (http:// ncdmph.usuhs.edu) as an academic center of excellence at the Uniformed Services University of the Health Sciences to lead federal efforts in developing and propagating core curricula, training, and research in disaster health.’’ A commenter recommended that we include the Joint Guidelines for Care of Children in the Emergency Department, developed by the American Academy of Pediatrics, the American College of Emergency Physicians, and the Emergency Nurses Association, as a resource for the final rule. A commenter suggested the addition of the phrase ‘‘private critical infrastructure’’ to the following statement on page 79086 of the proposed rule: ‘‘The Stafford Act authorizes the President to provide financial and other assistance to state and local governments, certain private nonprofit organizations, and individuals to support response, recovery, and mitigation efforts.’’ A commenter included several articles and referenced documentation on emergency preparedness and proper management and disposal of medical waste materials, while another recommended that CMS reference specific FEMA reference documents. Another commenter referred CMS to the Comprehensive Preparedness Guidelines 101 Template, although the commenter did not specify the source of this template. Response: We thank the commenters for their recommended edits throughout the document. The editorial suggestions are appreciated and noted. We also want to thank commenters for their recommendations for additional resources on emergency preparedness. We provided an extensive list of resources in the proposed and have included links to various resources in this final rule that facilities can use as resources during the development of their emergency preparedness plans. PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 63867 However, we note that these lists are not comprehensive, since we intend to allow facilities flexibility as they implement the emergency preparedness requirements. We encourage facilities to use any resources that they find helpful as they implement the emergency preparedness requirements. Omissions from the list of resources set out in the proposed rule do not indicate any intention on our part to exclude other resources from use by facilities. Comment: A commenter stated that the local emergency management and public health authorities are the bestplaced entities to coordinate their communities’ disaster preparedness and response, collaborating with hospitals as instrumental partners in this effort. Response: We stated in the proposed rule that local emergency management and public health authorities play a very important role in coordinating their community’s disaster preparedness and response activities. We proposed that each hospital develop an emergency plan that includes a process for ensuring cooperation and collaboration with local, tribal, regional, state and federal emergency preparedness officials’ efforts to ensure an integrated response during a disaster or emergency situation. We also proposed that hospitals participate in community mock disaster drills. As noted in the proposed rule, we believe that community-wide coordination during a disaster is vital to a community’s ability to maintain continuity of healthcare for the patient population during and after a disaster or emergency. Comment: A few commenters were concerned about the exclusion of specific requirements to account for the health and safety of healthcare workers. A commenter, in reference to pediatric healthcare, recommended that we consider adding a behavioral healthcare provision to the emergency preparedness requirements, which would account for the professional selfcare needs of healthcare providers. Another commenter suggested that we change the language on page 79092 of the proposed rule to include 5 phases of emergency management, with the addition of the phrase ‘‘protection of the safety and security of occupants in the facility.’’ Another commenter recommended that we include occupational health and safety elements in the four proposed emergency preparedness standards. Furthermore, the commenter recommended that we consult with the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Worker Education and Training Program E:\FR\FM\16SER2.SGM 16SER2 63868 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES2 of the National Institute for Environmental Health Sciences (NIEHS) for more information on integrating worker health and safety protections into emergency planning. Response: While we believe that providers should prioritize the health and safety of their healthcare workers during an emergency, we do not believe that it is appropriate to include detailed requirements within this regulation. As we have previously stated, the regulation is not intended to be overly prescriptive. Therefore, providers have the discretion to establish policies and procedures in their emergency preparedness plans that meet the minimum requirements in this regulation and that are tailored to the specific needs and circumstances of the facility. We note that providers should continue to comply with pertinent federal, state, or local laws regarding the protection of healthcare workers in the workplace. While it is not within the scope of this rule to address OSHA, NIOSH, or NIEHS work place regulations, we encourage providers and suppliers to consider developing policies and procedures to protect healthcare workers during an emergency. We refer readers to the following list of resources to aid providers and suppliers in the formulation of such policies and procedures: • https://www.osha.gov/SLTC/ emergencypreparedness/ • http://www.cdc.gov/niosh/topics/ emergency.html • http://www.niehs.nih.gov/health/ topics/population/occupational/ index.cfm Comment: A few commenters noted that while section 1135 of the Act waives certain Conditions of Participation (CoPs) during a public health emergency, there is no authority to waive the Conditions for Payment (CfPs). The commenters recommended that the Secretary thoroughly review the requirements under the CoPs and the CfPs and seek authority from Congress to waive additional requirements under the CfPs that are burdensome and that affect timely access to care during emergencies. Response: While we appreciate the concerns of the commenters, these comments are outside the scope of this rule. 1. Integrated Health Systems In the proposed rule, we proposed that for each separately certified healthcare facility to have an emergency preparedness program that includes an emergency plan, based on a risk VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 assessment that utilizes an all hazards approach, policies and procedures, a communication plan, and a training program. Comment: We received a few comments that suggested we allow integrated health systems to have one coordinated emergency preparedness program for the entire system. Commenters explained that an integrated health system could be comprised of two nearby hospitals, a LTC facility, a HHA, and a hospice. The commenters stated that under our proposed regulation, each entity would need to develop an individual emergency preparedness program in order to be in compliance. Commenters proposed that we allow for the development of one universal emergency preparedness program that encompasses one community-based risk assessment, separate facility-based risk assessments, integrated policies and procedures that meet the requirements for each facility, and coordinated communication plans, training and testing. They noted that allowing for a coordinated emergency preparedness program would ultimately reduce the burden placed on the individual facilities and provide for a more coordinated response during an emergency. Response: We appreciate the comments received on this issue. We agree that allowing integrated health systems to have a coordinated emergency preparedness program is in the best interest of the facilities and patients that comprise a health system. Therefore, we are revising the proposed requirements by adding a separate standard to the provisions applicable to each provider and supplier type. This separate standard will allow any separately certified healthcare facility that operates within a healthcare system to elect to be a part of the healthcare system’s unified emergency preparedness program. If a healthcare system elects to have a unified emergency preparedness program, this integrated program must demonstrate that each separately certified facility within the system actively participated in the development of the program. In addition, each separately certified facility must be capable of demonstrating that they can effectively implement the emergency preparedness program and demonstrate compliance with its requirements at the facility level. As always, each facility will be surveyed individually and will need to demonstrate compliance. Therefore, the unified program will also need to be developed and maintained in a manner PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 that takes into account the unique circumstances, patient populations, and services offered for each facility within the system. For example, for a unified plan covering both a hospital and a LTC facility, the emergency plan must account for the residents in the LTC facility as well as those patients within a hospital, while taking into consideration the difference in services that are provided at a LTC facility and a hospital. In addition, the healthcare system will need to take into account the resources each facility within the system has and any state laws that the facility must adhere to. The unified emergency preparedness program must also include a documented community– based risk assessment and an individual facility-based risk assessment for each separately certified facility within the health system, both utilizing an allhazards approach. The unified program must also include integrated policies and procedures that meet the emergency preparedness requirements specific to each provider type as set forth in their individual set of regulations. Lastly, the unified program must have a coordinated communication plan and training and testing program. We believe that this approach will allow a healthcare system to spread the cost associated with training and offer a financial advantage to each of the facilities within a system. In addition, we believe that, in some cases this approach will provide flexibility and could potentially result in a more coordinated response during an emergency that will enable a more successful outcome. 2. Requests for Technical Assistance and Funding The December 2013 proposed rule included an appendix of the numerous resources and documents used to develop the proposed rule. Specifically, the appendix to the proposed rule included helpful reports, toolkits, and samples from multiple government agencies such as ASPR, the CDC, FEMA, HRSA, AHRQ, and the Institute of Medicine (See Appendix A, 78 FR 79198). In response to our proposed rule, we received numerous comments requesting that we provide facilities with increased funding and technical assistance to implement our proposed regulations. Comment: A few commenters appreciated the resources that we provided in the proposed rule, but expressed concerns that, despite the resources referenced in the regulation, busy and resource-constrained facilities will not have a simple and organized way to access technical assistance and E:\FR\FM\16SER2.SGM 16SER2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations other valuable information in order to comply with the proposed requirements. Commenters indicated that despite the success of healthcare coalitions, they have not been established in every region. Commenters suggested that formal technical assistance should be available to facilities to help them successfully implement their emergency preparedness requirements. A commenter recommended that ASPR should lead this effort given its expertise in emergency preparedness planning and its charge to lead the nation in preventing, preparing for, and responding to the adverse health effects of public health emergencies. Another commenter suggested that we consider hosting regional meetings for facilities to share information and resources and that we provide region specific resources on our Web site. Commenters encouraged CMS to promote collaborative planning among facilities and provide the support needed for facilities to leverage each other’s resources. These commenters believe that networks of facilities will be in a better position than governmental resources to identify cost and time saving efficiencies, but need support from CMS to coordinate their efforts. Response: We appreciate the feedback from commenters and understand how valuable guidance and resources will be to providers and suppliers in order to comply with this regulation. We do not anticipate providing formal technical assistance, such as CMS-led trainings, to providers and suppliers. Instead, as with all of our regulations, we will release interpretive guidance for this regulation that will aid facilities in implementing these regulations and provide information regarding best practices. We strongly encourage facilities to review the interpretative guidance from us, use the guidance to identify best practices, and then network with other facilities to develop strategic plans. Providers and suppliers impacted by this regulation should collaborate and leverage resources in developing emergency preparedness programs to identify cost and time saving efficiencies. We note that in this final rule we have revised the proposed requirements to allow integrated health systems to elect to have one unified emergency preparedness program (see Section II.A.1.Intergrated Health Systems for a detailed discussion of the requirement). We believe that collaborative planning will not only leverage the financial burden on facilities, but also result in a more coordinated response to an emergency event. VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 In addition, we note that in the proposed rule, we indicated numerous resources related to emergency preparedness, including helpful reports, toolkits, and samples from ASPR, the CDC, FEMA, HRSA, AHRQ, and the Institute of Medicine (See Appendix A, 78 FR 79198). Providers and suppliers should use these many resources as templates and the framework for getting their emergency preparedness programs started. We also refer readers to SAMHSA’s Disaster Technical Assistance Center (DTAC) for more information on delivering an effective mental health and substance abuse (behavioral health) response to disasters at http://www.samhsa.gov/dtac/. Finally we note that ASPR, as a leader in healthcare system preparedness, developed and launched the Technical Resources, Assistance Center, and Information Exchange (TRACIE). TRACIE is designed to provide resources and technical assistance to healthcare system preparedness stakeholders in building a resilient healthcare system. There are numerous products and resources located within the TRACIE Web site that target specific provider types affected by this rule. While TRACIE does not focus specifically on the requirements implemented in this regulation, this is a valuable resource to aid a wide spectrum of partners with their health system emergency preparedness activities. We strongly encourage providers and suppliers to utilize TRACIE and leverage the information provided by ASPR. Comment: Some commenters noted that their region is currently experiencing a reduction in the federal funding they receive through the HPP. These commenters stated that the HPP program has proven to be successful and encouraged healthcare entities impacted by this regulation to engage their state HPP for technical assistance and training while developing their emergency preparedness programs. Commenters shared that HPP staff have established trusting and fundamental relationships with facilities, associations, and emergency managers throughout their state. Commenters expressed that while the program has been instrumental in supporting their state’s healthcare emergency response, it does not make sense to impose these new emergency preparedness regulations while financial resources through the HPP are diminishing. Commenters stressed that the HPP program alone cannot support the rollout of these new regulations and emphasized that a strong and wellfunded HHP program is needed to PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 63869 contribute to the successful implementation of these new requirements. Commenters also suggested that CMS offer training to the states’ HPP programs, so that these agencies can remain in a central leadership role within their states. Response: We appreciate the feedback and agree that the HPP program has been a fundamental resource for developing healthcare emergency preparedness programs. While we recognize that HPP funding is limited, we want to emphasize that the HPP program is not intended to solely fund a facility’s individual emergency preparedness program and activities. Despite the limited financial resources, healthcare facilities should continue to engage their healthcare coalitions and state HPP coordinators for training and guidance. We encourage healthcare facilities, particularly those in neighboring geographic areas, to collaborate and build relationships that will allow facilities to share and leverage resources. Comment: A few commenters noted that, while these new emergency preparedness regulations should be put in place to protect vulnerable communities, there should also be incentives to help facilities meet these new standards. Many commenters expressed concerns about the decrease in funding available to state and local governments. Most commenters recommended that grant funding and loan programs be provided to support hiring staff to develop or modify emergency plans. However, a few commenters suggested that federal funding should be allocated to the nation’s most vulnerable counties. These commenters believe that special federal funding consideration should not be provided to all, but rather should be given to those counties and cities with a uniquely dense population. A commenter believed that incentives should be put in place to reward those facilities that are found compliant with the new standards. In addition, several commenters requested that CMS provide additional Medicare payment to providers and suppliers for implementing these emergency preparedness requirements. Response: We currently expect facilities to have and develop policies and procedures for patient care and the overall operations. The emergency preparedness requirement may increase costs in the short term because resources will have to be devoted to the assessment and development of an emergency plan utilizing an all-hazards approach. While the requirements could result in some immediate costs to a E:\FR\FM\16SER2.SGM 16SER2 63870 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations provider or supplier, we believe that developing an emergency preparedness program will overall be beneficial to any provider or supplier. In addition, planning for the protection and care of patients, clients, residents, and staff during an emergency or a disaster is a good business practice. As we have previously noted, CMS has the authority to create and modify health and safety CoPs, which establish the requirements that a provider must meet in order to participate in the Medicare or Medicaid programs. mstockstill on DSK3G9T082PROD with RULES2 3. Requirement To Track Patients and Staff In the proposed rule, we requested comments on the feasibility of tracking staff and patients in outpatient facilities. Comment: Overall commenters agreed that there is not a crucial need for outpatient facilities to track their patients as compared to inpatient facilities. Commenters noted that outpatient providers and suppliers would most likely close their facilities prior to or immediately after an emergency, sending staff and patients home. We did not propose the tracking requirement for transplant centers, CORFs, Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services, and RHCs/FQHCs. For OPOs we proposed that they would only need to track staff. We stated that transplant centers’ patients and OPOs’ potential donors would be in hospitals, and thus, would be the hospital’s responsibility. Response: We agree with the majority of commenters and continue to believe that it is impractical for outpatient providers and suppliers to track patients and staff during and after an emergency. In the event of an emergency outpatient providers and suppliers will have the flexibility to cancel appointments and close their facilities. Therefore, we are finalizing the rule as proposed. Specifically, we do not require transplant centers, RHCs/FQHCs, CORFs, Clinics, Rehabilitation Agencies, and Public Health Agencies as providers of Outpatient Physical Therapy and Speech-Language Pathology Services to track their patients and staffs. We are also finalizing our proposal for OPOs to track staff only both during and after an emergency. A detailed discussion of comments specific to OPOs tracking staff can be found in section II.Q. of this final rule (Emergency Preparedness Regulations for Organ Procurement Organizations). VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 Comment: In addition to the feedback we received on whether we should require outpatient providers and suppliers to track their patients and staff, we also received varying comments in regards to the providers and suppliers that we did propose to meet the tracking requirement.Commenters supported the proposal for certain providers and suppliers to track staff and patients, and agreed that a system is needed. Some understood that the information about staff and patient location would be needed during an emergency, but stated that it would be burdensome and often unrealistic to expect providers and suppliers to locate individuals after an emergency event. Some commenters noted that patients at a receiving facility would be the responsibility of the receiving facility. Some commenters stated that tracking of patients going home is not their responsibility, or would be difficult to achieve. A commenter believed that tracking of staff would be a violation of staff’s privacy. A commenter stated that in their large facility, only the ‘‘staff on duty’’ at the time of the emergency would be in their staffing system. Some commenters stated that staff would be difficult to track because some facilities have hundreds or thousands of employees, and some staff may have left to be with their families. Some commenters suggested that CMS promote the use of voluntary registries to help track their outpatient populations and encouraged coordination of these registries among facility types. A few commenters stated that one of the tools discussed in the preamble for tracking patients; namely, The Joint Patient Assessment and Tracking System (JPATS) was only available for hospitals and did not include other providers such as LTC facilities, and several stated the system is incompatible with their IT systems. Response: For RNHCIs, PRTFs, PACE organizations, LTC facilities, ICFs/IID, hospitals, and CAHs, we proposed that these providers develop policies and procedures regarding a system to track the location of staff and patients in the hospital’s care both during and after an emergency. Despite providing services on an outpatient basis, we also proposed to require hospices, HHAs, and ESRD facilities to assume this responsibility because these providers and suppliers would be required to provide continuing patient care during an emergency. We also proposed the tracking requirement for ASCs because we believed an ASC would maintain PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 responsibility for their staff and patients if patients were in the facility. After carefully analyzing the issues raised by commenters regarding the process to track staff and patients during and after an emergency, we agree with the commenters that our proposed requirements could be unnecessarily burdensome. We are revising the tracking requirements based on the type of facility. For CAHs, Hospitals, and RNHCIs we are removing the proposed requirement for tracking after an emergency. Instead, in this final rule we require that these facilities must document the specific name and location of the receiving facility or other location for patients who leave the facility during the emergency. We would expect facilities to track their onduty staff and sheltered patients during an emergency and indicate where a patient is relocated to during an emergency (that is, to another facility, home, or alternate means of shelter, etc.). Also, since providers and suppliers are required to conduct a risk assessment and develop strategies for addressing emergency events identified by the risk assessment, we would expect the facility to include in its emergency plan a method for contacting off-duty staff during an emergency and procedures to address other contingencies in the event staff are not able to report to duty which may include but are not limited to staff from other facilities and state or federallydesignated health professionals. For PRTFs, LTC facilities, ICF/IIDs, PACE organizations, CMHCs, and ESRD facilities we are finalizing as proposed the requirement to track staff and patients both during and after an emergency. We have clarified that the requirement applies to tracking on-duty staff and sheltered patients. Furthermore, we clarify that if on-duty staff and sheltered patients are relocated during the emergency, the provider or supplier must document the specific name and location of the receiving facility or other location. Unlike inpatient facilities, PRTFs, ICF/IIDs, and LTC facilities are residential facilities and serve as the patient’s home, which is why in these settings we refer to the patients as ‘‘residents.’’ Similar to these residential facilities ESRD facilities, CMHCs, and PACE organizations, provide a continuum of care for their patients. Residents and patients of these facilities would anticipate returning to these facilities after an emergency. For this reason, we believe that it is imperative for these facilities to know where their residents/patients and staff are located during and after the E:\FR\FM\16SER2.SGM 16SER2 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES2 emergency to allow for repatriation and the continuation of regularly scheduled appointments. While we pointed out JPATS as a tool for providers and suppliers, we note that we indicated that we were not proposing a specific type of tracking system that providers and suppliers must use. We also indicated that in the proposed rule that a number of states have tracking systems in place or under development and the systems are available for use by healthcare providers and suppliers. We encourage providers and suppliers to leverage the support and resources available to them through local and national healthcare systems, healthcare coalitions, and healthcare organizations for resources and tools for tracking patients. We have also reviewed our proposal to require ASCs, hospices, and HHAs to track their staff and patients before and after an emergency. We discuss in detail the comments we received specific to these providers and suppliers and revisions to their proposed tracking requirement in their specific section later in this final rule. B. Implementation Date We proposed several variations on an implementation date for the emergency preparedness requirements (78 FR 79179). Regarding the implementation date, we requested information on the following issues: • A targeted approach to emergency preparedness that would apply the rule to one provider or supplier type or a subset of provider types, to learn from implementation prior to requiring compliance for all 17 types of providers and suppliers. • A phased-in approach that would implement the requirements over a longer time horizon, or differential time horizons for the different provider and supplier types. Comment: Most commenters recommended that CMS set a later implementation date for the emergency preparedness requirements. Some commenters recommended that we use a targeted approach, whereby the rule would be implemented first by one provider/supplier type or a subset of provider/supplier types, with later implementation by other provider/ supplier types, so they can learn from prior implementation at other facilities. Others recommended that CMS phase in the requirements over a longer time horizon. Many commenters recommended that CMS require implementation at hospitals or LTC facilities first, so that other facilities could benefit from the experience and lessons learned by these VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 providers. Some of these commenters stated that these providers have the most capacity to implement these requirements. A commenter recommended that hospitals implement the requirements of the rule first, followed by CAHs and other inpatient provider types and LTC facilities. Other provider and supplier types would follow thereafter. The commenter recommended that CMS establish a period of non-enforcement for each implementation phase, while a Phase 1 evaluation is conducted and feedback is given to other facilities. Several commenters, including major hospital associations, disagreed with CMS’ proposal to implement all of the requirements 1 year after the final rule is published. The commenters noted that implementation of all the requirements after 1 year would be burdensome and costly to many facilities. In addition, a few commenters noted that certain facilities, mainly rural and small facilities, may be at a disadvantage because they have not participated in national emergency preparedness planning efforts or because they lack the necessary resources to implement emergency preparedness plans. A few commenters drew a distinction between accredited and non-accredited facilities and recommended that hospitals implement the requirements within a year or 2 after publication of the final rule. Some of the commenters noted that non-accredited facilities, CAHs, HHAs, and hospices, would need more time. Several of these commenters also stated that hospitals that need more time for implementation should be able to propose to CMS a reasonable period of time to comply. A few commenters stated that the emergency preparedness proposal is unlike the standards utilized by the TJC and that enforcement of these requirements should be at a later date for both accredited and non-accredited facilities. Some commenters recommended that CMS give ASCs and FQHCs additional time to come into compliance. A commenter recommended that CMS set a later implementation date for the requirements and provide a flexible implementation timeframe based on provider type and resources. A few commenters stated that the implementation timeline is too short for rehabilitation facilities, long-term acute care facilities, LTC facilities, behavioral health inpatient facilities, and ICF/IIDs. A few commenters recommended that CMS phase-in implementation on a standard-by-standard basis. A commenter recommended that LTC facilities implement the requirements 12 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 63871 to 18 months after hospitals. Furthermore, the commenter recommended an 18 to 24 month phasein of emergency systems and a 24 to 38 month phase-in for the training and testing requirements. Another commenter recommended that facilities be allowed to comply with the initial planning requirements within 2 years, and then be allowed to comply with the subsistence and infrastructure requirements in years 3 and 4. The commenters varied in their recommendations on the timeframe CMS should use for the implementation date. These recommendations ranged from 6 months to 5 years, with a few commenters recommending even longer periods. Some commenters noted that applying a targeted approach, covering one or a subset of provider classes to learn from implementation prior to extending the rule to all groups, would also allow a longer period of time for other provider/supplier types to prepare for implementation. Furthermore, a commenter noted that a phased in approach would help to alleviate the cost burden on facilities that would need to create an emergency plan and train and test staff. Response: We appreciate the commenters’ feedback. We considered a phased-in approach in a number of ways. We looked at phasing in the implementation of various providers and suppliers; and phasing in the various standards of the regulation. We concluded that this approach would be too difficult to implement, enforce, and evaluate. Also, this would not allow communities to have a comprehensive approach to emergency preparedness. However, we agree that there should be a later implementation date for the emergency preparedness requirements. However, we do not believe that a targeted or phased-in approach to implementation is appropriate. One thing we proposed and are now finalizing to address this concern is extending the implementation timeframe for the requirements to 1 year after the effective date of this final rule (see section section II, Provisions of the Proposed Rule and Responses to Public Comments, part B, Implementation Date). We believe it is imperative that each provider thinks in terms broader than their own facility, and plan for how they would serve similar and other healthcare facilities as well as the whole community during and surrounding an emergency event. To encourage providers to develop a comprehensive and coordinated approach to emergency preparedness, all providers need to adopt the requirements in this final rule at the same time. E:\FR\FM\16SER2.SGM 16SER2 mstockstill on DSK3G9T082PROD with RULES2 63872 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations Commenters have stated that hospitals that are TJC-accredited are part of the Hospital Preparedness Program (HPP) program, and those hospitals that follow National Fire Protection Association (NFPA®) standards, have already established most of the emergency preparedness requirements set out in this rule. Based on CDC’s National Health Statistics Reports; Number 37, March 24, 2011, page 2 (NCHS–2008PanFluand EP_NHAMCSSurveyReport_2011.pdf), about 67.9 percent of hospitals had plans for all six hazards (epidemicpandemic, biological, chemical, nuclearradiological, explosive-incendiary, and natural incidents). Nearly all hospitals (99.0 percent) had emergency response plans that specifically addressed chemical accidents or attacks, which were not significantly different from the prevalence of plans for natural disasters (97.8 percent), epidemics or pandemics (94.1 percent), and biological accidents or attacks. However, we also believe that other facilities will be ready to begin implementation of these rules at the same time as hospitals. We believe that most facilities already have some basic emergency preparedness requirements that can be built upon to meet the requirements set out in this final rule. We note that we have modified or eliminated some of our proposed requirements for certain providers and suppliers, as discussed later in this final rule, which should ease concerns about implementation. Therefore, we believe that all affected providers and suppliers will be able to comply with these requirements 1 year after the final rule is published. We do not believe a period of nonenforcement is appropriate as it will further prolong the implementation of necessary and life-saving emergency preparedness planning requirements by facilities. A later implementation date will leave the most vulnerable patient populations and unprepared facilities without a valuable, life-saving emergency preparedness plan should an emergency arise. We have not received comments that persuaded us that a later implementation date for these requirements of more than 1 year is beneficial or appropriate for providers and suppliers or their patients. In response to commenters that opposed our proposal to implement the requirements 1 year after the final rule was published and recommended that we afford facilities more time to implement the requirements, we do not believe that the requirements will be overly burdensome or overly costly to providers and suppliers. We note, as we have heard from many commenters, that VerDate Sep2014 19:01 Sep 15, 2016 Jkt 238001 many facilities already have established emergency preparedness plans, as required by accrediting organizations. However, we acknowledge that there may be a significant amount of work that small facilities and those with limited resources will need to undertake to establish an emergency preparedness plan that conforms to the requirements set out in this regulation. However, we believe that prolonging the requirements in this final rule by 1 year will provide sufficient time for implementation among the various facilities to meet the emergency preparedness requirements. We encourage facilities to engage and collaborate with their local partners and healthcare coalitions in their area for assistance. Facilities may also access ASPR’s TRACIE web portal, which is a healthcare emergency preparedness information gateway that helps stakeholders at the federal, state, local, tribal, non-profit, and for-profit levels have access to information and resources to improve preparedness, response, recovery, and mitigation efforts. ASPR TRACIE, located at: https://asprtracie.hhs.gov/, is an excellent resource for the various CMS providers and suppliers as they seek to implement the enhanced emergency preparedness requirements. We encourage facilities to engage and collaborate with their local partners and healthcare coalitions in their area for technical assistance as they include local experts and can provide regional information that can inform the requirements as set forth. Comment: Some commenters recommended that CMS implement all of the emergency preparedness requirements 1 year after the final rule is published. Other commenters recommended that CMS implement the requirements as soon as the final rule is published or set an implementation date that is less than 1 year from the effective date of this final rule. A few of these commenters, including a major beneficiary advocacy group, stated that implementation should begin as soon as practicable, or immediately after the final rule is published and cautioned against a later implementation date that may leave facilities without important emergency preparedness plans during an emergency. Some of these commenters stated that hospitals in particular already have emergency preparedness plans in place and are well equipped and prepared to implement the requirements set out in these regulations over the course of a year. Some commenters noted that most hospitals are fully aware of the 4 emergency preparedness requirements set out in the proposed rule through PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 current accreditation standards. Furthermore, the commenters noted that these four requirements would not impose any additional burdens on hospitals. A few commenters acknowledged that some hospitals are not under the purview of an accrediting agency and therefore may need up to 1 year to implement the requirements. Response: We appreciate the commenters’ feedback. We agree with the commenters’ view that implementation of the requirements should occur 1 year after the final rule is published for all 17 types of providers and suppliers. We believe that an implementation date for these requirements that is 1 year after the effective date of this final rule will allow all facilities to develop an emergency preparedness plan that meets all of the requirements set out within these regulations. While we understand why some commenters would want these requirements to be implemented shortly after publication of the final rule, we also understand some commenters’ concerns about that timeframe. We believe that facilities will need a period of time after the final rule is published to plan, develop, and implement the emergency preparedness requirements in the final rule. Accordingly, we believe that 1 year is a sufficient amount of time for facilities to meet these requirements. Comment: A few commenters recommended that CMS include a provision that would allow facilities to apply for additional time extensions or waivers for implementation. A commenter recommended that CMS allow facilities to rely on their existing policies if the facility can demonstrate that the existing policies align with the emergency preparedness plan requirements and achieve a similar outcome. Response: We do not agree with including a provision that will allow for facilities to apply for extensions or waivers to the emergency preparedness requirements. We believe that an implementation date that is beyond 1 year after the effective date of this final rule for these requirements is inappropriate and leaves the most vulnerable facilities and patient populations without life-saving emergency preparedness plans. However, we do understand that some facilities, especially smaller and more rural facilities, may experience difficulties developing their emergency preparedness plans. Therefore, we believe that setting an implementation date of 1 year after the effective date of this final rule for these requirements will give these and other facilities E:\FR\FM\16SER2.SGM 16SER2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations sufficient time for compliance. As stated earlier, we encourage facilities to form coalitions in their area for assistance in meeting these requirements. We also encourage facilities to utilize the many resources we have included in the proposed and final rule. We appreciate that some facilities have existing emergency preparedness plans. However, all facilities will be required to develop and maintain an emergency preparedness plan based on an all-hazards approach and address the four major elements of emergency preparedness in their plan that we have identified in this final rule. Each facility will be required to evaluate its current emergency preparedness plan and activities to ensure that it complies with the new requirements. Comment: A few commenters recommended that CMS implement enforcement of the final rule when the interpretive guidance (IG) is finalized by CMS. A few commenters noted that this implementation data should include a period of engagement with hospitals and other providers and suppliers, a period to allow for the development and testing of surveyor tools, and a readiness review of state survey agencies that is complete and publicly available. A commenter recommended that facilities implement the requirements 5 years after the IGs have been published. Another commenter recommended that CMS phase-in implementation in terms of enforcement and roll out, allowing time for full implementation and assistance to facilities and state surveyors. A few commenters recommended that providers be allowed a period of time where they are held harmless during a transitional planning period, where providers may be allotted more time to plan and implement the emergency preparedness requirements. Response: We disagree with the…
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