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DEPARTMENT OF HEALTH AND AAR/IP After Action Report/Improvement HSPD Homeland Security Presidential HUMAN SERVICES Plan Directive ACHC Accreditation Commission for HVA Hazard Vulnerability Analysis or Centers for Medicare & Medicaid Health Care, Inc. Assessment Services ACHE American College of Healthcare ICFs/IID Intermediate Care Facilities for Executives Individuals with Intellectual Disabilities AHA American Hospital Association ICR Information Collection Requirements 42 CFR Parts 403, 416, 418, 441, 460, AO Accrediting Organization IDG Interdisciplinary Group 482, 483, 484, 485, 486, 491, and 494 AOA/HFAP American Osteopathic IOM Institute of Medicine [CMS–3178–F] Association/Healthcare Facilities JPATS Joint Patient Assessment and Accreditation Program Tracking System RIN 0938–AO91 ASC Ambulatory Surgical Center LEP Limited English Proficiency ARCAH Accreditation Requirements for LD Leadership Medicare and Medicaid Programs; Critical Access Hospitals LPHA Local Public Health Agencies Emergency Preparedness ASPR Assistant Secretary for Preparedness LSC Life Safety Code Requirements for Medicare and and Response LTC Long Term Care Medicaid Participating Providers and BLS Bureau of Labor Statistics MMRS Metropolitan Medical Response Suppliers BTCDP Bioterrorism Training and System Curriculum Development Program MRC Medical Reserve Corps AGENCY: Centers for Medicare & CAH Critical Access Hospital MS Medical Staff Medicaid Services (CMS), HHS. CAMCAH Comprehensive Accreditation NDMS National Disaster Medical System Manual for Critical Access Hospitals NFs Nursing Facilities ACTION: Final rule. CAMH Comprehensive Accreditation NFPA National Fire Protection Association NIMS National Incident Management SUMMARY: This final rule establishes Manual for Hospitals CASPER Certification and the Survey System national emergency preparedness Provider Enhanced Reporting NIOSH National Institute for Occupational requirements for Medicare- and CDC Centers for Disease Control and Safety and Health Medicaid-participating providers and Prevention NLTN National Laboratory Training suppliers to plan adequately for both CON Certificate of Need Network natural and man-made disasters, and CfCs Conditions for Coverage and NRP National Response Plan coordinate with federal, state, tribal, Conditions for Certification NRF National Response Framework regional, and local emergency CHAP Community Health Accreditation NSS National Security Staff preparedness systems. It will also assist Program OBRA Omnibus Budget Reconciliation Act providers and suppliers to adequately CMHC Community Mental Health Center OIG Office of the Inspector General CMS Centers for Medicare and Medicaid OPHPR Office of Public Health prepare to meet the needs of patients, Services Preparedness and Response residents, clients, and participants COI Collection of Information OPO Organ Procurement Organization during disasters and emergency CoPs Conditions of Participation OPT Outpatient Physical Therapy situations. Despite some variations, our CORF Comprehensive Outpatient OPTN Organ Procurement and regulations will provide consistent Rehabilitation Facilities Transplantation Network emergency preparedness requirements, CPHP Centers for Public Health OSHA Occupational Safety and Health enhance patient safety during Preparedness Administration emergencies for persons served by CRI Cities Readiness Initiative PACE Program for the All-Inclusive Care for Medicare- and Medicaid-participating DHS Department of Homeland Security the Elderly DHHS Department of Health and Human PAHPA Pandemic and All-Hazards facilities, and establish a more Services Preparedness Act coordinated and defined response to DNV GL Det Norske Veritas GL—Healthcare PAHPRA Pandemic and All-Hazards natural and man-made disasters. DOL Department of Labor Preparedness Reauthorization Act DATES: Effective date: These regulations DPU Distinct Part Units PCT Patient Care Technician are effective on November 15, 2016. DSA Donation Service Area PPE Personal Protection Equipment Incorporation by reference: The EOP Emergency Operations Plans PHEP Public Health Emergency incorporation by reference of certain EC Environment of Care Preparedness publications listed in the rule is EMP Emergency Management Plan PHS Act Public Health Service Act approved by the Director of the Federal EP Emergency Preparedness PIN Policy Information Notice ESAR–VHP Emergency System for Advance PPD Presidential Policy Directive Register November 15, 2016. Registration of Volunteer Health PRTF Psychiatric Residential Treatment Implementation date: These Professionals Facilities regulations must be implemented by ESF Emergency Support Function QAPI Quality Assessment and Performance November 15, 2017. ESRD End-Stage Renal Disease Improvement FOR FURTHER INFORMATION CONTACT: FEMA Federal Emergency Management QIES Quality Improvement and Evaluation Janice Graham, (410) 786–8020. Agency System Mary Collins, (410) 786–3189. FDA Food and Drug Administration RFA Regulatory Flexibility Act Diane Corning, (410) 786–8486. FORHP Federal Office of Rural Health RNHCIs Religious Nonmedical Health Care Kianna Banks (410) 786–3498. Policy Institutions Ronisha Blackstone, (410) 786–6882. FRI Federal Reserve Inventories RHC Rural Health Clinic Alpha-Banu Huq, (410) 786–8687. FQHC Federally Qualified Health Center SAMHSA Substance Abuse and Mental Lisa Parker, (410) 786–4665. GAO Government Accountability Office Health Services Administration HFAP Healthcare Facilities Accreditation SLP Speech Language Pathology SUPPLEMENTARY INFORMATION: Program SNF Skilled Nursing Facility Acronyms HHA Home Health Agencies SNS Strategic National Stockpile HPP Hospital Preparedness Program TEFRA Tax Equity and Fiscal AAAHC Accreditation Association for HRSA Health Resources and Services Responsibility Act Ambulatory Health Care, Inc. Administration TFAH Trust for America’s Health AAAASF American Association for HSC Homeland Security Council TJC The Joint Commission Accreditation for Ambulatory Surgery HSEEP Homeland Security Exercise and TRACIE Technical Resources, Assistance Facilities, Inc. Evaluation Program Center, and Information Exchange

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TTX Tabletop Exercise R. Emergency Preparedness Regulations for that establish a comprehensive, UMRA Unfunded Mandates Reform Act Rural Health Clinics (RHCs) and consistent, flexible, and dynamic UNOS United Network for Organ Sharing Federally Qualified Health Centers regulatory approach to emergency UPMC University of Pittsburgh Medical (FQHCs) (§ 491.12) preparedness and response that Center S. Emergency Preparedness Regulations for WHO World Health Organization End-Stage Renal Disease (ESRD) incorporates the lessons learned from Facilities (§ 494.62) the past, combined with the proven best Table of Contents III. Provisions of the Final Regulations practices of the present. We recognize I. Overview A. Changes Included in the Final Rule that central to this approach is to A. Executive Summary B. Incorporation by Reference develop and guide emergency 1. Purpose IV. Collection of Information preparedness and response within the 2. Summary of the Major Provisions V. Regulatory Impact Analysis framework of our national healthcare B. Current State of Emergency VI. Waiver of Proposed Rulemaking system. To this end, these requirements Preparedness I. Overview also encourage providers and suppliers C. Statutory and Regulatory Background to coordinate their preparedness efforts II. Provisions of the Proposed Rule and A. Executive Summary within their own communities and Responses to Public Comments A. General Comments 1. Purpose states as well as across state lines, as 1. Integrated Health Systems We have reviewed existing Medicare necessary, to achieve their goals. 2. Requests for Technical Assistance and emergency regulatory preparedness 2. Summary of the Major Provisions Funding requirements for both providers and We are issuing emergency 3. Requirement To Track Patients and Staff suppliers. We found that many B. Implementation Date preparedness requirements that will be C. Emergency Preparedness Regulations for providers and suppliers have emergency consistent and enforceable for all Hospitals (§ 482.15) preparedness requirements, but those affected Medicare and Medicaid 1. Risk Assessment and Emergency Plan requirements do not go far enough in providers and suppliers (referred to (§ 482.15(a)) ensuring that these providers and collectively as ‘‘facilities,’’ throughout 2. Policies and Procedures (§ 482.15(b) suppliers are equipped and prepared to the remainder of this final rule where 3. Communication Plan (§ 482.15(c) help protect those they serve during 4. Training and Testing (§ 482.15(d) applicable). This final rule addresses the emergencies and disasters. Hospitals, for three key essentials we believe are 5. Emergency Fuel and Generator Testing example, are currently required to have (§ 482.15(e) necessary for maintaining access to D. Emergency Preparedness Regulations for emergency power and lighting in some healthcare services during emergencies: Religious Nonmedical Health Care specified areas and there must be safeguarding human resources, Institutions (RNHCIs) (§ 403.748) facilities for emergency gas and water maintaining business continuity, and E. Emergency Preparedness Regulations for supply. We believe that these existing protecting physical resources. Current Ambulatory Surgical Centers (ASCs) requirements are generally insufficient regulations for Medicare and Medicaid (§ 416.54) in the face of the needs of the patients, providers and suppliers do not F. Emergency Preparedness Regulations for staff and communities, and do not adequately address these key elements. Hospices (§ 418.113) address inconsistency in the level of G. Emergency Preparedness Regulations for Based on our research and Psychiatric Residential Treatment emergency preparedness amongst consultation with stakeholders, we have Facilities (PRTFs) (§ 441.184) healthcare providers. For example, identified four core elements that are H. Emergency Preparedness Regulations for while some accreditation organizations central to an effective and Programs of All-Inclusive Care for the have standards that exceed CMS’ comprehensive framework of emergency Elderly (PACE) (§ 460.84) current requirements for hospitals by preparedness requirements for the I. Emergency Preparedness Regulations for requiring them to conduct a risk various Medicare- and Medicaid- Transplant Centers (§ 482.78) assessment, there are other providers participating providers and suppliers. J. Emergency Preparedness Regulations for and suppliers who do not have any The four elements of the emergency Long-Term Care (LTC) Facilities emergency preparedness requirements, preparedness program are as follows: (§ 483.73) • K. Emergency Preparedness Regulations for such as Community Mental Health Risk assessment and emergency Intermediate Care Facilities for Centers (CMHCs) and Psychiatric planning: We are requiring facilities to Individuals With Intellectual Disabilities Residential Treatment Facilities perform a risk assessment that uses an (ICF/IID) (§ 483.475) (PRTFs). We concluded that current ‘‘all-hazards’’ approach prior to L. Emergency Preparedness Regulations for emergency preparedness requirements establishing an emergency plan. The all- Home Health Agencies (HHAs) (§ 484.22) are not comprehensive enough to hazards risk assessment will be used to M. Emergency Preparedness Regulations address the complexities of the actual identify the essential components to be for Comprehensive Outpatient emergencies. Over the past several integrated into the facility emergency Rehabilitation Facilities (CORFs) years, the United States has been plan. An all-hazards approach is an (§ 485.68) N. Emergency Preparedness Regulations for challenged by several natural and man- integrated approach to emergency Critical Access Hospitals (CAHs) made disasters. As a result of the preparedness planning that focuses on (§ 485.625) September 11, 2001 terrorist attacks, the capacities and capabilities that are O. Emergency Preparedness Regulations for subsequent anthrax attacks, the critical to preparedness for a full Clinics, Rehabilitation Agencies, and catastrophic hurricanes in the Gulf spectrum of emergencies or disasters. Public Health Agencies as Providers of Coast states in 2005, flooding in the This approach is specific to the location Outpatient Physical Therapy and Midwestern states in 2008, the 2009 of the provider or supplier and Speech-Language Pathology Services H1N1 influenza pandemic, tornadoes considers the particular types of hazards (Organizations) (§ 485.727) and floods in the spring of 2011, and most likely to occur in their areas. These P. Emergency Preparedness Regulations for Community Mental Health Centers Hurricane Sandy in 2012, our nation’s may include, but are not limited to, (CMHCs) (§ 485.920) health security and readiness for public care-related emergencies; equipment Q. Emergency Preparedness Regulations for health emergencies have been on the and power failures; interruptions in Organ Procurement Organizations national agenda. This final rule issues communications, including cyber- (OPOs) (§ 486.360) emergency preparedness requirements attacks; loss of a portion or all of a

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facility; and, interruptions in the normal developing a Multi-year Training and Medicare and Medicaid participating supply of essentials, such as water and Exercise Plan (TEP) in line with the hospitals and other providers and food. Additional information on the (HSEEP): http://www.fema.gov/media- suppliers through the conditions of emergency preparedness cycle can be library-data/20130726-1914-25045- participation (CoPs) and conditions for found at the Federal Emergency 8890/hseep_apr13_.pdf. coverage (CfCs) established by this rule. Management Agency (FEMA) National B. Current State of Emergency Preparedness System Web site located C. Statutory and Regulatory Background Preparedness at: https://www.fema.gov/threat-and- Various sections of the Social Security hazard-identification-and-risk- As previously discussed, numerous Act (the Act) define the types of assessment. natural and man-made disasters have providers and suppliers that may • Policies and procedures: We are challenged the United States over the participate in Medicare and Medicaid requiring that facilities develop and past several years. Disasters can disrupt and list the requirements that each implement policies and procedures that the environment of healthcare and provider and supplier must meet to be support the successful execution of the change the demand for healthcare eligible for Medicare and Medicaid emergency plan and risks identified services; therefore, it is essential that participation. The Act also authorizes during the risk assessment process. healthcare facilities integrate emergency the Secretary to establish other • Communication plan: We are management into their daily functions requirements as necessary to protect the requiring facilities to develop and and values. On December 27, 2013, we health and safety of patients, although maintain an emergency preparedness published a proposed rule titled, the wording of such authority differs communication plan that complies with ‘‘Medicare and Medicaid Programs; slightly between provider and supplier both federal and state law. Patient care Emergency Preparedness Requirements types. Such requirements may include must be well-coordinated within the for Medicare and Medicaid Participating the CoPs for providers, CfCs for facility, across healthcare providers, and Providers and Suppliers’’ (78 FR 79082). suppliers, and requirements for long- with state and local public health In this proposed rule we included a term care facilities. The CoPs and CfCs departments and emergency robust discussion about the current state are intended to protect public health management agencies and systems to of emergency preparedness and federal and safety and promote high quality protect patient health and safety in the emergency preparedness activities that care for all persons. Furthermore, the event of a disaster. The following link have established a foundation for the Public Health Service (PHS) Act sets is to FEMA’s comprehensive development and expansion of forth additional regulatory requirements preparedness guide to develop and healthcare emergency preparedness that certain Medicare providers and maintain emergency operations plans: systems. In addition, the December 2013 suppliers are required to meet in order https://www.fema.gov/media-library- proposed rule included an appendix of to participate. data/20130726-1828-25045-0014/ the numerous resources and documents The following are the statutory and _ _ _ cpg 101 comprehensive preparedness used to develop the proposed rule. We regulatory citations for the providers _ _ _ _ guide developing and maintaining refer readers to the proposed rule for and suppliers for which we are issuing _ _ _ _ emergency operations plans 2010.pdf. this background information. emergency preparedness regulations: During an emergency, it is critical that The December 2013 proposed rule • Religious Nonmedical Health Care hospitals, and all providers/suppliers, included discussion of previous events, Institutions (RNHCIs)—section 1821 of have a system to contact appropriate such as the 2009 H1N1 influenza the Act and 42 CFR 403.700 through staff, patients’ treating physicians, and pandemic, the 2001 anthrax attacks, the 403.756. other necessary persons in a timely tornados in 2011 and 2012, and • Ambulatory Surgical Centers manner to ensure continuation of Hurricane Sandy in 2012. In 2014, the (ASCs)—section 1832(a)(2)(F)(i) of the patient care functions throughout the United States faced a number of new Act and 42 CFR 416.2 and 416.40 facilities and to ensure that these and emerging diseases, such as MERS- through 416.52. functions are carried out in a safe and CoV and Ebola, and a nationwide • Hospices—section 1861(dd)(1) of effective manner. outbreak of Enterovirus D68, which was the Act and 42 CFR 418.52 through • Training and testing: We are confirmed in 938 people in 46 states 418.116. requiring that a facility develop and between mid-August and October 21, • Inpatient Psychiatric Services for maintain an emergency preparedness 2014 (http://www.cdc.gov/non-polio- Individuals Under Age 21 in Psychiatric training and testing program. A well- enterovirus/outbreaks/EV-D68- Residential Treatment Facilities organized, effective training program outbreaks.html). We believe that (PRTFs)—sections1905(a) and 1905(h) must include initial training for new finalizing the emergency preparedness of the Act and 42 CFR 441.150 through and existing staff in emergency rule is an important part of improving 441.182 and 42 CFR 483.350 through preparedness policies and procedures as the national response to Ebola and any 483.376. well as annual refresher trainings. The infectious disease threats. Healthcare • Programs of All-Inclusive Care for facility must offer annual emergency providers have raised concerns about the Elderly (PACE)—sections 1894, preparedness training so that staff can their safety when caring for patients 1905(a), and 1934 of the Act and 42 CFR demonstrate knowledge of emergency with Ebola, citing the need for advanced 460.2 through 460.210. procedures. The facility must also preparation, effective policies and • Hospitals—section 1861(e)(9) of the conduct drills and exercises to test the procedures, communication plans, and Act and 42 CFR 482.1 through 482.66. emergency plan to identify gaps and sufficient training and testing, • Transplant Centers—sections areas for improvement. The Homeland particularly for personal protection 1861(e)(9) and 1881(b)(1) of the Act and Security Exercise and Evaluation equipment (PPE). The response 42 CFR 482.68 through 482.104. Program (HSEEP), developed by FEMA, highlighted the importance of • Long Term Care (LTC) Facilities— includes a section on the establishment establishing written procedures, Skilled Nursing Facilities (SNFs)— of a Training and Exercise Planning protocols, and policies ahead of an under section 1819 of the Act, Nursing Workshop (TEPW). The TEPW section emergency event. With the finalization Facilities (NFs)—under section 1919 of provides guidance to organizations in of the emergency preparedness rule, this the Act, and 42 CFR 483.1 through conducting an annual TEPW and type of planning will be mandated for 483.180.

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• Intermediate Care Facilities for proposals are refined and adopted in would need more time to comply with Individuals with Intellectual Disabilities this final rule. the proposed requirements. (ICF/IID)—section 1905(d) of the Act A few commenters disagreed with our II. Provisions of the Proposed Rule and and 42 CFR 483.400 through 483.480. statement that hospitals should have Responses to Public Comments • Home Health Agencies (HHAs)— emergency preparedness plans and sections 1861(o), 1891 of the Act and 42 In response to our December 2013 stated that hospitals are already CFR 484.1 through 484.55. proposed rule, we received nearly 400 prepared for emergencies. A commenter • Comprehensive Outpatient public comments. Commenters included objected to the statement that hospital Rehabilitation Facilities (CORFs)— individuals, healthcare professionals leadership has not prioritized disaster section 1861(cc)(2) of the Act and 42 and corporations, national associations, preparedness. CFR 485.50 through 485.74. health departments and emergency A commenter recommended that the • Critical Access Hospitals (CAHs)— management professionals, and proposed emergency preparedness sections 1820 and 1861(mm) of the Act individual facilities that would be requirements be reduced and simplified and 42 CFR 485.601 through 485.647. impacted by the regulation. Most to reflect the minimum requirements • Clinics, Rehabilitation Agencies, comments centered around the hospital that each provider type is expected to and Public Health Agencies as Providers requirements, but could be applied to meet. Other commenters objected to the of Outpatient Physical Therapy and the additional provider and supplier entire proposal and the establishment of Speech-Language Pathology Services— types. We also received comments additional regulations for healthcare section 1861(p) of the Act and 42 CFR specific to the requirements we facilities. Response: We disagree with the 485.701 through 485.729. proposed for other individual provider commenters who stated that the • Community Mental Health Centers and supplier types. In addition, we solicited comments on specific issues. emergency preparedness regulations are (CMHCs)—section 1861(ff)(3)(B)(i)(ii) of inappropriate or unnecessary. the Act, section 1913(c)(1) of the PHS We have organized our responses to the comments as follows: (1) General Healthcare facilities in the United States Act, and 42 CFR 410.110. have faced many challenges over the • Organ Procurement Organizations comments; (2) implementation date; (3) comments specific to hospitals and years including hurricanes, tornados, (OPOs)—section 1138 of the Act and floods, wild fires, and pandemics. those that apply to the overall section 371 of the PHS Act and 42 CFR Facilities that do not have plans requirements of the regulation; and (4) 486.301 through 486.348. established prior to an emergency or a • comments specific to other providers Rural Health Clinics (RHCs)— disaster may face difficulties providing and suppliers. section 1861(aa) of the Act and 42 CFR continuity of care for their patients. In 491.1 through 491.11; Federally A. General Comments addition, without proper training, Qualified Health Centers (FQHCs)— healthcare workers may find it difficult We received the following comments section 1861(aa) of the Act and 42 CFR to implement emergency preparedness suggesting improvement to our 491.1 through 491.11, except 491.3. plans during an emergency or a disaster. • End-Stage Renal Disease (ESRD) regulatory approach or requesting Upon review of the current emergency Facilities—sections 1881(b), 1881(c), clarification of the resources used to preparedness requirements for providers 1881(f)(7) of the Act and 42 CFR 494.1 develop our proposals: and suppliers participating in Medicare through 494.180. Comment: Most commenters and Medicaid, we concluded that the The proposed rule responded to supported our proposal to require current requirements are not concerns from the Congress, the Medicare and Medicaid participating comprehensive enough to address the healthcare community, and the public facilities to establish an emergency complexities of actual emergencies. We regarding the ability of healthcare preparedness plan. Many of these believe that, currently, in the event of a facilities to plan and execute commenters noted that this proposal is disaster, healthcare facilities across the appropriate emergency response timely and necessary in light of past nation will not have the necessary procedures for disasters. In the emergencies and natural disasters. emergency planning and preparation in proposed rule, we identified four core Response: We thank the commenters place to adequately protect the health elements that we believe are central to for their support. We continue to believe and safety of their patients. In addition, an effective emergency preparedness that our current regulations for we believe that the current regulatory system and must be addressed to offer Medicare and Medicaid providers and patchwork of federal, state, and local a more comprehensive framework of suppliers do not adequately address laws and guidelines, combined with emergency preparedness requirements emergency preparedness planning and various accrediting organizations’ for the various Medicare- and Medicaid- that emergency preparedness CoPs for emergency preparedness standards, falls participating providers and suppliers. providers and CfCs for suppliers should far short of what is needed for The four elements are—(1) risk be implemented at this time. healthcare facilities to be adequately assessment and emergency planning; (2) Comment: Several commenters prepared for a disaster. Therefore, we policies and procedures; (3) disagreed with our proposal to establish proposed to establish comprehensive, communication plan; and (4) training emergency preparedness requirements consistent, and flexible emergency and testing. We proposed that these core for Medicare and Medicaid providers preparedness regulations that components be used across provider and suppliers. Some commenters were incorporate lessons learned from the and supplier types as diverse as concerned that this proposal would past with the proven best practices of hospitals, organ procurement place undue burden and financial strain the present. Finalizing these proposals, organizations, and home health on facilities. Most of these commenters with the modifications discussed later agencies, while attempting to tailor stated that it would be difficult to in this final rule, will help healthcare requirements for individual provider implement additional regulations facilities be better prepared in case of a and supplier types to meet their specific without additional payment through disaster or emergency. We note that the needs and circumstances, as well as the Medicare, Medicaid, or the Hospital majority of the comments to the needs of their patients, residents, Preparedness Program (HPP). The proposed rule agree with the clients, and participants. These commenters also stated that facilities establishment of some type of regulatory

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framework for emergency preparedness account the differences that exist developing their emergency planning, which further supports our between individual facilities. The preparedness plans. position that establishing emergency commenters noted that the proposal Comment: A few commenters stated preparedness regulations is the most does not acknowledge the diversity of that the proposed provisions were too appropriate course of action. different facilities and instead requires a specific and detailed. Some commenters In response to comments that request ‘‘one size fits all’’ emergency believed that, like other CoPs, the additional time for compliance or preparedness plan. The commenters proposal should include provisions that additional funds, we refer readers to the recommended that CMS address the are more flexible. The commenters discussion on the implementation date variation between facilities in the noted that more specificity should be and further discussions on funding in emergency preparedness requirements. included in CMS’ interpretive guidance this final rule. Some commenters stated that the documents (IGs). Comment: Some commenters stated proposed requirements are Response: We disagree with that the term ‘‘ensure’’ was used inappropriate because they mostly commenters. We believe that these numerous times in the proposed rule apply to hospitals, and cannot be regulations strike a balance between the and that the term was over-used. applied to other healthcare settings. A specific and the general. We have not Commenters stated that in some commenter noted that smaller hospitals prescribed or mandated specific circumstances we stated providers and with limited capabilities, like LTCHs, technology or tools, nor have we suppliers had to ‘‘ensure’’ elements of should be allowed to work with their included detailed requirements for how the plan that might be beyond their local emergency response networks to emergency preparedness plans should control during an emergency. A develop emergency preparedness plans be written. The regulations are broad commenter suggested that we replace that reflect those hospitals’ limitations. enough that facilities can formulate an the word ‘‘ensure’’ with the term ‘‘strive Response: We believe our approach, effective emergency preparedness plan, to achieve.’’ with the changes to our proposal based on a facility-based and Response: We used the word ‘‘ensure’’ discussed later in this final rule, community-based risk assessment or ‘‘ensuring’’ to convey that each appropriately addresses the differences utilizing an all-hazards approach, that provider and supplier will be held between the 17 provider and supplier includes appropriate policies and accountable for complying with the types covered by these regulations. We procedures, a communication plan, and requirements in this rule. However, to believe that emergency preparedness training and testing. In meeting the avoid any ambiguity, we have removed regulations that are too specific may emergency preparedness requirements, the term ‘‘ensure’’ and ‘‘ensuring’’ from become outdated over time, as providers can tailor specific details to the regulation text of all providers and technology and the nature of threats their facilities’ and their patients’ needs. suppliers and have addressed the change, and that emergency Facilities can also exceed the requirements in a more direct manner. preparedness regulations that are too requirements in this final rule, if they Comment: Some commenters were broad may be ineffective. Therefore, we believe it is in their patients’ and their concerned that the proposed emergency proposed four main components that are facilities’ interests to do so. preparedness requirements duplicate consistent with the principles as set Comment: A few commenters existing requirements by The Joint forth in the National Preparedness Cycle suggested that CMS require facilities to Commission (TJC). TJC is a CMS- contained within the National include other entities, stakeholders, and approved accrediting organization that Preparedness System (link (see: https:// individuals in their emergency has standards and survey procedures www.fema.gov/national-preparedness- preparedness planning. Specifically, a that meet or exceed those used by CMS system) that can be used across diverse few commenters suggested that facilities and state surveyors. Facilities accredited healthcare settings, while tailoring include patients, their family members, under a Medicare approved specific requirements for individual and vulnerable populations, including accreditation program, such as TJC’s, provider and supplier types based on older adults, people with disabilities, may be ‘‘deemed’’ by CMS to be in their needs and circumstances, as well and those who are linguistically compliance with the CoPs. Most of these as the needs and circumstances of their isolated, in their emergency commenters recommended that CMS patients, residents, clients, and preparedness planning. A few rely on existing TJC standards. Other participants. We continue to believe that commenters also recommended that commenters noted that CMS used TJC these four components, and the facilities include patients and their manual citations from 2007 through variations in the specific requirements families in emergency preparedness 2008. The commenters noted that of these components, appropriately education. A few commenters changes have been made since then and address variation amongst provider and recommended that front line workers recommended that CMS refer to the supplier settings and facilities with an and their workers’ unions be included most recent TJC manual. appropriate amount of flexibility. We do in the emergency preparedness Response: We discussed TJC not believe that we have taken a ‘‘one planning. A commenter suggested that standards in the proposed rule as a size fits all’’ approach in these CMS emphasize the full continuum of point of reference for emergency regulations. emergency management activities and preparedness standards that currently We agree with the commenter who identify relevant national associations exist for healthcare facilities, absent stated that smaller hospitals should be and resources for each provider type. additional federal regulations. We note allowed to work with their local health A commenter noted that local that CMS has the authority to create and department and emergency management emergency management officials are modify CoPs, which establish the agency to develop emergency rarely included in emergency planning. requirements a provider must meet to preparedness plans and we encourage The commenter recommended adding a participate in the Medicare or Medicaid these facilities to engage in healthcare requirement that would require facilities program. Also, we note that facilities coalitions in their area for assistance in to submit their emergency preparedness that exceed CMS’s requirements will meeting these requirements. However, plan to their local emergency still remain compliant. we note that we are not mandating that management agency for review and Comment: A few commenters stated smaller facilities confer with local assessment, and for assistance on that the proposal did not take into emergency response networks while sheltering and evacuation procedures.

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Response: In the proposed rule, we Comment: A few commenters information technology (IT) system proposed to require certain facilities to questioned CMS’ definition of an failure. develop a method for sharing emergency. A commenter disagreed Response: We understand the information from the emergency plan with the proposed rule’s definition of commenter’s concerns and believe that that the facility determines is ‘‘emergency’’ and ‘‘disaster.’’ The facilities should consider planning for appropriate with patients/residents and commenter stated that the proposed rule recovery of operations during the their families or representatives. A definitions exclude internal or smaller emergency or disaster response. facility may choose to involve other disasters that a hospital may declare. Recovery of operations will require that entities in the development of an Furthermore, the commenter noted that facilities coordinate efforts with the emergency preparedness plan or they the definitions should include mass relevant health department and can provide emergency preparedness casualty incidents and internal emergency management agencies to education to patients’ families and emergencies or disasters that a facility restore facilities to their previous state caregivers. During the development of may declare. Another commenter prior to the emergency or disaster event. the emergency plan, facilities may also requested clarification as to whether the Our new emergency preparedness choose to include patients, community regulation applies to external or internal requirements focus on continuity of members and others in the process. emergencies. operations, not recovery of operations. However, we are not mandating these Response: In the proposed rule, we Facilities can choose to include actions as we believe such a defined an ‘‘emergency’’ or ‘‘disaster’’ as recovery of operations planning in their requirement would impose an excessive an event affecting the overall target emergency preparedness plan, but we burden on providers and suppliers; population or the community at large have not made recovery of operations instead, we encourage and will allow that precipitates the declaration of a planning a requirement. facilities the discretion to confer with state of emergency at a local, state, We refer commenters that are entities and resources that they consider regional, or national level by an interested in recovery of operations appropriate while creating an authorized public official such as a planning to the following resources for Governor, the Secretary of the more information: emergency preparedness plan and • strongly encourage that facilities Department of Health and Human National Disaster Recovery include individuals with disabilities Services (HHS), or the President of the Framework (NDRF): https:// and others with access and functional United States. However, we agree with www.fema.gov/national-disaster- needs in their planning. the commenter’s observation that the recovery-framework. • Continuity Guidance Circular 1 Comment: A commenter definition of an ‘‘emergency’’ or (CGC 1), and Continuity Guidance for recommended that emergency ‘‘disaster’’ should include internal emergency or disaster events. Therefore, Non-Federal Entities (States, Territories, preparedness plans should account for we clarify our statement that an Tribal, and Local Government children’s special needs during an ‘‘emergency’’ or ‘‘disaster’’ is an event Jurisdictions and Private Sector emergency. The commenter stated that that can affect the facility internally as Organizations) http://www.fema.gov/ emergency preparedness plans should well as the overall target population or pdf/about/org/ncp/cont_guidance1.pdf. include children’s medication and the community at large. • National Preparedness System medical device needs, challenges We believe that hospitals should have (https://www.fema.gov/national- regarding patient transfer for neonatal a single emergency plan that addresses preparedness-system) and pediatric intensive care patients, all-hazards, including internal • Comprehensive Preparedness Guide and issues involving behavioral health emergencies and a man-made 101 http://www.fema.gov/media-library- and family reunification. emergency (or both) or natural disaster. data/20130726-1828-25045-0014/ A commenter recommended that CMS Hospitals have the discretion to cpg_101_comprehensive_preparedness_ collaborate closely with the Emergency determine when to activate their guide_developing_and_maintaining Medical Services for Children (EMSC) emergency plan and whether to apply _emergency_operations_ program administered by the Health their emergency plan to internal or plans_2010.pdf) Resources and Services Administration smaller emergencies or disasters that Comment: A commenter requested (HRSA). The commenter noted that this may occur within their facilities. We clarification on whether hospitals program focuses on improving the encourage hospitals to prepare for all- would have direct access to the pediatric components of the EMS hazards that may affect their patient Emergency System for Advance system. population and apply their emergency Registration of Volunteer Health Response: We appreciate the preparedness plans to any emergency or Professionals (ESAR–VHP). commenter’s concerns. As required in disaster that may arise. Furthermore, we A commenter recommended that CMS § 482.15(a)(1), (2), and (3), when a encourage hospitals that may be dealing work with other federal agencies, provider or supplier develops an with an internal emergency or disaster including the Department of Homeland emergency preparedness plan, we will to maintain communication with Security (DHS) and the Federal expect that the provider/supplier will external emergency preparedness Emergency Management Agency use a facility-based and community- entities and other facilities where (FEMA) to expand ESAR–VHP and based risk assessment to develop a plan appropriate. Medical Reserve Corps (MRC) team that addresses that facility’s patient Comment: A few commenters were deployments to a 3 month rotation population, including at-risk concerned that the proposed rule did basis. The commenter also populations. If the provider serves not require planning for recovery of recommended that CMS purchase and children, or if the majority of its patient operations. The commenters pre-position Federal Reserve Inventories population is children, as is the case for recommended that CMS include (FRI) at healthcare distributorships. children’s hospitals, we will expect the requirements for facilities to plan for the Response: Hospitals do not have provider to take into account children’s return of normal operations after an direct access to the Emergency System access and functional needs during an emergency. A commenter recommended for Advance Registration of Volunteer emergency or disaster in its emergency that CMS include requirements for Health Professional (ESAR–VHP). The preparedness plan. provider preparedness in case of an Assistant Secretary for Preparedness

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and Response (ASPR) manages the authority over drug and alcohol Comment: A commenter objected to ESAR–VHP program. The program is treatment centers. use of the term ‘‘volunteers’’ in the administered on the state level. A In response to the question about a proposed rule. The commenter stated hospital would request volunteer health Certificate of Need, we note that that this term was not defined and professionals through State Emergency facilities must formulate an emergency recommended that the proposal be Management. For more information, preparedness plan that complies with limited to healthcare professionals used reviewers may email ASPR at state and local laws. A Certificate of to address surge needs during an [email protected] or visit the ESAR/VHP Need is a document that is needed in emergency. Another commenter Web site: http://www.phe.gov/esarvhp/ some states and local jurisdiction before recommended that the regulation text pages/home.aspx. Volunteer the creation, acquisition, or expansion should be revised to include the deployments typically last for 2 weeks of a facility is allowed. Facilities should language, ‘‘Use of health care and are not extended without the check with their state and local volunteers’’, to further clarify this agreement of the volunteer. authorities in regards to Certificate of distinction. In regards to the comment on the Need requirements. Response: We provided information Federal Reserve Inventories, we believe Comment: A commenter requested on the use of volunteers in the proposed that the commenter may be referring to clarification on a facility’s responsibility rule (78 FR 79097), specifically with the Strategic National Stockpile (SNS). to patients that have already evacuated reference to the Medical Reserve Corps The SNS program is a national the facility on their own. and the ESAR–VHP programs. Private repository of antibiotics, chemical Response: Facilities are required to citizens or medical professionals not antidotes, antitoxins, life-support track the location of staff and patients in employed by a hospital or facility often medications, and medical supplies. It is the facility’s care during an emergency. offer their voluntary services to not within CMS’ purview to purchase, The facility is not required to track the hospitals or other entities during an administer, or maintain SNS stock. We location of patients who have emergency or disaster event. Therefore, refer commenters who have questions voluntarily left on their own, since they we believe that facilities should have about the SNS program to the Centers are no longer in the facility’s care. policies and procedures in place to for Disease Control and Prevention However, if a patient voluntarily leaves address the use of volunteers in an (CDC) Web site at http:// a facility’s care during an emergency or emergency, among other emergency emergency.cdc.gov/stockpile/index.asp. a disaster, the facility may choose to staffing strategies. We believe such Comment: A commenter noted that inform the appropriate health policies should address, among other CMS did not include emergency department and emergency management things, the process and role for preparedness requirements for transport or emergency medical services integration of healthcare professionals units (fire and rescue units, and authorities if it believes the patient may that are locally-designated, such as the ambulances). Furthermore, the be in danger. Medical Reserve Corps (https:// commenter questioned whether a Comment: A commenter questioned www.medicalreservecorps.gov/Home Certificate of Need (CON) is necessary whether the requirements take into Page), or state-designated, such as during an emergency. account the role of the physician during Emergency System for Advance Another commenter questioned why emergency preparedness planning. The Registration of Volunteer Health large single specialty and multispecialty commenter questioned whether Professional (ESAR–VHP), (http:// medical groups are not discussed as physicians will be required to provide www.phe.gov/esarvhp/pages/ included or excluded in this rule. The feedback during the planning process, home.aspx) that have assisted in commenter noted that these entities whether physicians would have a role addressing surge needs during prior have Medicare and Medicaid provider in preserving patient medical emergencies. As with previous status; therefore, should be included in documentation, whether physicians emergencies, facilities may choose to this rule. Another commenter would be involved in determining utilize assistance from the MRC or questioned whether the proposed arrangements for patients during a through the state ESAR–VHP program. regulations would apply to residential cessation of operations, and to what We believe the description of healthcare drug and alcohol treatment centers. The extent physicians would be required to volunteers is already included in the commenter noted that if this is the case, participate in training and testing. current requirement and does not need it would be difficult for these centers to Response: Individual physicians are to be further defined. meet the proposed requirements due to not required, but are encouraged, to Comment: A commenter questioned if lack of funding. develop and maintain emergency the proposal will require facilities to Response: The emergency preparedness plans. However, plan for an electromagnetic event. The preparedness requirements only pertain physicians that work in a facility that is commenter noted that protecting against to the 17 provider and supplier types required to develop and maintain an and treating patients after an discussed previously in this rule, which emergency preparedness plan can and electromagnetic event is costly. have existing CoPs or CfCs. These are encouraged to provide feedback or Another commenter recommended provider and supplier types do not suggestions for best practices. In that the rule explicitly include and include fire and rescue units, and addition, physicians that are employed address the threats of fire, wildfires, ambulances, or single-specialty/multi- by the facility and all new and existing tornados, and flooding. The commenter specialty medical groups. Entities that staff must participate in emergency notes that these scenarios are not work with hospitals or any of the other preparedness training and testing. We included in the National Planning provider and supplier types covered by have not mandated a specific role for Scenarios (NPS). this regulation may have a role in the physicians during an emergency or Response: We expect facilities to provider’s or supplier’s emergency disaster event, but we expect facilities to develop an emergency preparedness preparedness plan, and providers or delineate responsibilities for all of their plan that is based on a facility-based suppliers may choose to consider the facility’s workers in their emergency and community-based risk assessment role of these entities in their emergency preparedness plans and to determine using an ‘‘all-hazards’’ approach. If a preparedness plan. In addition, we note the appropriate level of training for each provider or supplier determines that its that CMS does not exercise regulatory professional role. facility or community is at risk for an

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electromagnetic event or natural commenter noted that while we However, we note that these lists are not disasters, such as fires, wildfires, included references to HSPD 5, 21, and comprehensive, since we intend to tornados, and flooding, the provider or 8 in the proposed rule, the commenter allow facilities flexibility as they supplier can choose to incorporate recommended that all of the HSPDs implement the emergency preparedness planning for such an event into its should have been included. requirements. We encourage facilities to emergency preparedness plan. We note Furthermore, the commenter noted that use any resources that they find helpful that compliance with these HSPD 7 in particular, which does not as they implement the emergency requirements, including a determination provide a specific role for HHS, should preparedness requirements. Omissions of whether the provider or supplier have been referenced since it includes from the list of resources set out in the based its emergency preparedness plan discussion of critical infrastructure proposed rule do not indicate any on facility-based and community-based protection and the role it plays in all- intention on our part to exclude other risk assessments using an all-hazards hazards mitigation. resources from use by facilities. approach, will be assessed through on- A commenter suggested that we add Comment: A commenter stated that site surveys by CMS, State Survey the following text to section II.B.1.a. of the local emergency management and Agencies, or Accreditation the proposed rule (78 FR 79085): public health authorities are the best- Organizations with CMS-approved ‘‘HSPD–21 tasked the establishment of placed entities to coordinate their accreditation programs. the National Center for Disaster communities’ disaster preparedness and Comment: A few commenters had Medicine and Public Health (http:// response, collaborating with hospitals as recommendations for the structure and ncdmph.usuhs.edu) as an academic instrumental partners in this effort. organization of the proposed rule. A center of excellence at the Uniformed Response: We stated in the proposed commenter recommended that CMS Services University of the Health rule that local emergency management specify the 17 providers and supplier Sciences to lead federal efforts in and public health authorities play a very types to which the rule would apply in developing and propagating core important role in coordinating their the first part of the rule, so that facilities curricula, training, and research in community’s disaster preparedness and could verify whether or not the disaster health.’’ response activities. We proposed that regulations would apply to them. A few A commenter recommended that we each hospital develop an emergency commenters suggested that the include the Joint Guidelines for Care of plan that includes a process for ensuring requirements of the proposed rule Children in the Emergency Department, cooperation and collaboration with should not be included in the CoPs, but developed by the American Academy of local, tribal, regional, state and federal instead comprise a separate regulatory Pediatrics, the American College of emergency preparedness officials’ chapter specific to emergency Emergency Physicians, and the efforts to ensure an integrated response preparedness. Emergency Nurses Association, as a during a disaster or emergency Response: We included a list of the resource for the final rule. situation. We also proposed that provider and supplier types affected by A commenter suggested the addition hospitals participate in community the emergency preparedness of the phrase ‘‘private critical mock disaster drills. As noted in the requirements in the proposed rule’s infrastructure’’ to the following proposed rule, we believe that Table of Contents (78 FR 79083 through statement on page 79086 of the community-wide coordination during a 79084) and in the preamble text 78 FR proposed rule: ‘‘The Stafford Act disaster is vital to a community’s ability 79090. Thus, we believe that we clearly authorizes the President to provide to maintain continuity of healthcare for listed the affected providers and financial and other assistance to state the patient population during and after suppliers at the very beginning of the and local governments, certain private a disaster or emergency. proposed rule. nonprofit organizations, and individuals Comment: A few commenters were We also believe the emergency to support response, recovery, and concerned about the exclusion of preparedness requirements should be mitigation efforts.’’ specific requirements to account for the included in the CoPs for providers, the A commenter included several health and safety of healthcare workers. CfCs for suppliers, and requirements for articles and referenced documentation A commenter, in reference to pediatric LTC facilities. These CoPs, CfCs, and on emergency preparedness and proper healthcare, recommended that we requirements for LTC facilities are management and disposal of medical consider adding a behavioral healthcare intended to protect public health and waste materials, while another provision to the emergency safety and ensure that high quality care recommended that CMS reference preparedness requirements, which is provided to all persons. Facilities specific FEMA reference documents. would account for the professional self- must meet their respective CoPs, CfCs, Another commenter referred CMS to the care needs of healthcare providers. or requirements in order to participate Comprehensive Preparedness Another commenter suggested that we in the Medicare and Medicaid programs. Guidelines 101 Template, although the change the language on page 79092 of We are able to enforce and monitor commenter did not specify the source of the proposed rule to include 5 phases of compliance with the CoPs, CfCs, and this template. emergency management, with the requirements for LTC facilities through Response: We thank the commenters addition of the phrase ‘‘protection of the the survey process. Therefore, we for their recommended edits throughout safety and security of occupants in the believe that the emergency preparedness the document. The editorial suggestions facility.’’ Another commenter requirements are included in the most are appreciated and noted. We also want recommended that we include appropriate regulatory chapters. to thank commenters for their occupational health and safety elements Comment: A few commenters recommendations for additional in the four proposed emergency suggested additional citations for the resources on emergency preparedness. preparedness standards. Furthermore, proposed rule, recommended that we We provided an extensive list of the commenter recommended that we include specific reference material, and resources in the proposed and have consult with the Occupational Safety suggested edits to the preamble included links to various resources in and Health Administration (OSHA), the language. A commenter stated that we this final rule that facilities can use as National Institute for Occupational omitted some references in the preamble resources during the development of Safety and Health (NIOSH), and the discussion of the proposed rule. The their emergency preparedness plans. Worker Education and Training Program

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of the National Institute for assessment that utilizes an all hazards that takes into account the unique Environmental Health Sciences (NIEHS) approach, policies and procedures, a circumstances, patient populations, and for more information on integrating communication plan, and a training services offered for each facility within worker health and safety protections program. the system. For example, for a unified into emergency planning. Comment: We received a few plan covering both a hospital and a LTC Response: While we believe that comments that suggested we allow facility, the emergency plan must providers should prioritize the health integrated health systems to have one account for the residents in the LTC and safety of their healthcare workers coordinated emergency preparedness facility as well as those patients within during an emergency, we do not believe program for the entire system. a hospital, while taking into that it is appropriate to include detailed Commenters explained that an consideration the difference in services requirements within this regulation. As integrated health system could be that are provided at a LTC facility and we have previously stated, the comprised of two nearby hospitals, a a hospital. In addition, the healthcare regulation is not intended to be overly LTC facility, a HHA, and a hospice. The system will need to take into account prescriptive. Therefore, providers have commenters stated that under our the resources each facility within the the discretion to establish policies and proposed regulation, each entity would system has and any state laws that the procedures in their emergency need to develop an individual facility must adhere to. The unified preparedness plans that meet the emergency preparedness program in emergency preparedness program must minimum requirements in this order to be in compliance. Commenters also include a documented community– regulation and that are tailored to the proposed that we allow for the based risk assessment and an individual specific needs and circumstances of the development of one universal facility-based risk assessment for each facility. We note that providers should emergency preparedness program that separately certified facility within the continue to comply with pertinent encompasses one community-based risk health system, both utilizing an all- federal, state, or local laws regarding the assessment, separate facility-based risk hazards approach. The unified program protection of healthcare workers in the assessments, integrated policies and must also include integrated policies workplace. procedures that meet the requirements and procedures that meet the emergency While it is not within the scope of this for each facility, and coordinated preparedness requirements specific to rule to address OSHA, NIOSH, or communication plans, training and each provider type as set forth in their NIEHS work place regulations, we testing. They noted that allowing for a individual set of regulations. Lastly, the encourage providers and suppliers to coordinated emergency preparedness unified program must have a consider developing policies and program would ultimately reduce the coordinated communication plan and procedures to protect healthcare burden placed on the individual training and testing program. We believe workers during an emergency. We refer facilities and provide for a more that this approach will allow a readers to the following list of resources coordinated response during an healthcare system to spread the cost to aid providers and suppliers in the emergency. associated with training and offer a Response: We appreciate the formulation of such policies and financial advantage to each of the comments received on this issue. We procedures: facilities within a system. In addition, agree that allowing integrated health • https://www.osha.gov/SLTC/ we believe that, in some cases this systems to have a coordinated approach will provide flexibility and emergencypreparedness/ emergency preparedness program is in • http://www.cdc.gov/niosh/topics/ could potentially result in a more the best interest of the facilities and coordinated response during an emergency.html patients that comprise a health system. • http://www.niehs.nih.gov/health/ emergency that will enable a more Therefore, we are revising the proposed successful outcome. topics/population/occupational/ requirements by adding a separate index.cfm standard to the provisions applicable to 2. Requests for Technical Assistance Comment: A few commenters noted each provider and supplier type. This and Funding that while section 1135 of the Act separate standard will allow any The December 2013 proposed rule waives certain Conditions of separately certified healthcare facility included an appendix of the numerous Participation (CoPs) during a public that operates within a healthcare system resources and documents used to health emergency, there is no authority to elect to be a part of the healthcare develop the proposed rule. Specifically, to waive the Conditions for Payment system’s unified emergency the appendix to the proposed rule (CfPs). The commenters recommended preparedness program. If a healthcare included helpful reports, toolkits, and that the Secretary thoroughly review the system elects to have a unified samples from multiple government requirements under the CoPs and the emergency preparedness program, this agencies such as ASPR, the CDC, FEMA, CfPs and seek authority from Congress integrated program must demonstrate HRSA, AHRQ, and the Institute of to waive additional requirements under that each separately certified facility Medicine (See Appendix A, 78 FR the CfPs that are burdensome and that within the system actively participated 79198). In response to our proposed affect timely access to care during in the development of the program. In rule, we received numerous comments emergencies. addition, each separately certified requesting that we provide facilities Response: While we appreciate the facility must be capable of with increased funding and technical concerns of the commenters, these demonstrating that they can effectively assistance to implement our proposed comments are outside the scope of this implement the emergency preparedness regulations. rule. program and demonstrate compliance Comment: A few commenters with its requirements at the facility appreciated the resources that we 1. Integrated Health Systems level. provided in the proposed rule, but In the proposed rule, we proposed As always, each facility will be expressed concerns that, despite the that for each separately certified surveyed individually and will need to resources referenced in the regulation, healthcare facility to have an emergency demonstrate compliance. Therefore, the busy and resource-constrained facilities preparedness program that includes an unified program will also need to be will not have a simple and organized emergency plan, based on a risk developed and maintained in a manner way to access technical assistance and

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other valuable information in order to In addition, we note that in the contribute to the successful comply with the proposed proposed rule, we indicated numerous implementation of these new requirements. Commenters indicated resources related to emergency requirements. Commenters also that despite the success of healthcare preparedness, including helpful reports, suggested that CMS offer training to the coalitions, they have not been toolkits, and samples from ASPR, the states’ HPP programs, so that these established in every region. CDC, FEMA, HRSA, AHRQ, and the agencies can remain in a central Commenters suggested that formal Institute of Medicine (See Appendix A, leadership role within their states. technical assistance should be available 78 FR 79198). Providers and suppliers Response: We appreciate the feedback to facilities to help them successfully should use these many resources as and agree that the HPP program has implement their emergency templates and the framework for getting been a fundamental resource for preparedness requirements. A their emergency preparedness programs developing healthcare emergency commenter recommended that ASPR started. We also refer readers to preparedness programs. While we should lead this effort given its SAMHSA’s Disaster Technical recognize that HPP funding is limited, expertise in emergency preparedness Assistance Center (DTAC) for more we want to emphasize that the HPP planning and its charge to lead the information on delivering an effective program is not intended to solely fund nation in preventing, preparing for, and mental health and substance abuse a facility’s individual emergency responding to the adverse health effects (behavioral health) response to disasters preparedness program and activities. of public health emergencies. Another at http://www.samhsa.gov/dtac/. Despite the limited financial resources, commenter suggested that we consider Finally we note that ASPR, as a leader healthcare facilities should continue to hosting regional meetings for facilities in healthcare system preparedness, engage their healthcare coalitions and to share information and resources and developed and launched the Technical state HPP coordinators for training and that we provide region specific Resources, Assistance Center, and guidance. We encourage healthcare resources on our Web site. Commenters Information Exchange (TRACIE). facilities, particularly those in encouraged CMS to promote TRACIE is designed to provide neighboring geographic areas, to collaborative planning among facilities resources and technical assistance to collaborate and build relationships that and provide the support needed for healthcare system preparedness will allow facilities to share and facilities to leverage each other’s stakeholders in building a resilient leverage resources. resources. These commenters believe healthcare system. There are numerous Comment: A few commenters noted that networks of facilities will be in a products and resources located within that, while these new emergency better position than governmental the TRACIE Web site that target specific preparedness regulations should be put resources to identify cost and time provider types affected by this rule. in place to protect vulnerable saving efficiencies, but need support While TRACIE does not focus communities, there should also be from CMS to coordinate their efforts. specifically on the requirements incentives to help facilities meet these Response: We appreciate the feedback implemented in this regulation, this is new standards. Many commenters from commenters and understand how a valuable resource to aid a wide expressed concerns about the decrease valuable guidance and resources will be spectrum of partners with their health in funding available to state and local to providers and suppliers in order to system emergency preparedness governments. Most commenters comply with this regulation. We do not activities. We strongly encourage recommended that grant funding and anticipate providing formal technical providers and suppliers to utilize loan programs be provided to support assistance, such as CMS-led trainings, to TRACIE and leverage the information hiring staff to develop or modify providers and suppliers. Instead, as provided by ASPR. emergency plans. However, a few with all of our regulations, we will Comment: Some commenters noted commenters suggested that federal release interpretive guidance for this that their region is currently funding should be allocated to the regulation that will aid facilities in experiencing a reduction in the federal nation’s most vulnerable counties. implementing these regulations and funding they receive through the HPP. These commenters believe that special provide information regarding best These commenters stated that the HPP federal funding consideration should practices. We strongly encourage program has proven to be successful and not be provided to all, but rather should facilities to review the interpretative encouraged healthcare entities impacted be given to those counties and cities guidance from us, use the guidance to by this regulation to engage their state with a uniquely dense population. A identify best practices, and then HPP for technical assistance and commenter believed that incentives network with other facilities to develop training while developing their should be put in place to reward those strategic plans. Providers and suppliers emergency preparedness programs. facilities that are found compliant with impacted by this regulation should Commenters shared that HPP staff have the new standards. In addition, several collaborate and leverage resources in established trusting and fundamental commenters requested that CMS developing emergency preparedness relationships with facilities, provide additional Medicare payment to programs to identify cost and time associations, and emergency managers providers and suppliers for saving efficiencies. We note that in this throughout their state. Commenters implementing these emergency final rule we have revised the proposed expressed that while the program has preparedness requirements. requirements to allow integrated health been instrumental in supporting their Response: We currently expect systems to elect to have one unified state’s healthcare emergency response, it facilities to have and develop policies emergency preparedness program (see does not make sense to impose these and procedures for patient care and the Section II.A.1.Intergrated Health new emergency preparedness overall operations. The emergency Systems for a detailed discussion of the regulations while financial resources preparedness requirement may increase requirement). We believe that through the HPP are diminishing. costs in the short term because collaborative planning will not only Commenters stressed that the HPP resources will have to be devoted to the leverage the financial burden on program alone cannot support the assessment and development of an facilities, but also result in a more rollout of these new regulations and emergency plan utilizing an all-hazards coordinated response to an emergency emphasized that a strong and well- approach. While the requirements could event. funded HHP program is needed to result in some immediate costs to a

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provider or supplier, we believe that Comment: In addition to the feedback responsibility for their staff and patients developing an emergency preparedness we received on whether we should if patients were in the facility. program will overall be beneficial to any require outpatient providers and After carefully analyzing the issues provider or supplier. In addition, suppliers to track their patients and raised by commenters regarding the planning for the protection and care of staff, we also received varying process to track staff and patients during patients, clients, residents, and staff comments in regards to the providers and after an emergency, we agree with during an emergency or a disaster is a and suppliers that we did propose to the commenters that our proposed good business practice. As we have meet the tracking requirements could be unnecessarily previously noted, CMS has the authority requirement.Commenters supported the burdensome. We are revising the to create and modify health and safety proposal for certain providers and tracking requirements based on the type CoPs, which establish the requirements suppliers to track staff and patients, and of facility. For CAHs, Hospitals, and that a provider must meet in order to agreed that a system is needed. Some RNHCIs we are removing the proposed participate in the Medicare or Medicaid understood that the information about requirement for tracking after an emergency. Instead, in this final rule we programs. staff and patient location would be require that these facilities must needed during an emergency, but stated 3. Requirement To Track Patients and document the specific name and that it would be burdensome and often Staff location of the receiving facility or other unrealistic to expect providers and In the proposed rule, we requested location for patients who leave the suppliers to locate individuals after an facility during the emergency. We comments on the feasibility of tracking emergency event. Some commenters staff and patients in outpatient facilities. would expect facilities to track their on- noted that patients at a receiving facility duty staff and sheltered patients during Comment: Overall commenters agreed would be the responsibility of the that there is not a crucial need for an emergency and indicate where a receiving facility. Some commenters patient is relocated to during an outpatient facilities to track their stated that tracking of patients going patients as compared to inpatient emergency (that is, to another facility, home is not their responsibility, or home, or alternate means of shelter, facilities. Commenters noted that would be difficult to achieve. A outpatient providers and suppliers etc.). commenter believed that tracking of Also, since providers and suppliers would most likely close their facilities staff would be a violation of staff’s are required to conduct a risk prior to or immediately after an privacy. A commenter stated that in assessment and develop strategies for emergency, sending staff and patients their large facility, only the ‘‘staff on addressing emergency events identified home. We did not propose the tracking duty’’ at the time of the emergency by the risk assessment, we would expect requirement for transplant centers, would be in their staffing system. Some the facility to include in its emergency CORFs, Clinics, Rehabilitation commenters stated that staff would be plan a method for contacting off-duty Agencies, and Public Health Agencies as difficult to track because some facilities staff during an emergency and Providers of Outpatient Physical have hundreds or thousands of procedures to address other Therapy and Speech-Language employees, and some staff may have left contingencies in the event staff are not Pathology Services, and RHCs/FQHCs. to be with their families. Some able to report to duty which may For OPOs we proposed that they would commenters suggested that CMS include but are not limited to staff from only need to track staff. We stated that promote the use of voluntary registries other facilities and state or federally- transplant centers’ patients and OPOs’ to help track their outpatient designated health professionals. potential donors would be in hospitals, populations and encouraged For PRTFs, LTC facilities, ICF/IIDs, and thus, would be the hospital’s coordination of these registries among PACE organizations, CMHCs, and ESRD responsibility. facility types. A few commenters stated facilities we are finalizing as proposed Response: We agree with the majority that one of the tools discussed in the the requirement to track staff and of commenters and continue to believe preamble for tracking patients; namely, patients both during and after an that it is impractical for outpatient The Joint Patient Assessment and emergency. We have clarified that the providers and suppliers to track patients Tracking System (JPATS) was only requirement applies to tracking on-duty and staff during and after an emergency. available for hospitals and did not staff and sheltered patients. In the event of an emergency outpatient include other providers such as LTC Furthermore, we clarify that if on-duty providers and suppliers will have the facilities, and several stated the system staff and sheltered patients are relocated flexibility to cancel appointments and is incompatible with their IT systems. during the emergency, the provider or close their facilities. Therefore, we are supplier must document the specific finalizing the rule as proposed. Response: For RNHCIs, PRTFs, PACE name and location of the receiving Specifically, we do not require organizations, LTC facilities, ICFs/IID, facility or other location. Unlike transplant centers, RHCs/FQHCs, hospitals, and CAHs, we proposed that inpatient facilities, PRTFs, ICF/IIDs, and CORFs, Clinics, Rehabilitation these providers develop policies and LTC facilities are residential facilities Agencies, and Public Health Agencies as procedures regarding a system to track and serve as the patient’s home, which providers of Outpatient Physical the location of staff and patients in the is why in these settings we refer to the Therapy and Speech-Language hospital’s care both during and after an patients as ‘‘residents.’’ Similar to these Pathology Services to track their emergency. Despite providing services residential facilities ESRD facilities, patients and staffs. We are also on an outpatient basis, we also proposed CMHCs, and PACE organizations, finalizing our proposal for OPOs to track to require hospices, HHAs, and ESRD provide a continuum of care for their staff only both during and after an facilities to assume this responsibility patients. Residents and patients of these emergency. A detailed discussion of because these providers and suppliers facilities would anticipate returning to comments specific to OPOs tracking would be required to provide these facilities after an emergency. For staff can be found in section II.Q. of this continuing patient care during an this reason, we believe that it is final rule (Emergency Preparedness emergency. We also proposed the imperative for these facilities to know Regulations for Organ Procurement tracking requirement for ASCs because where their residents/patients and staff Organizations). we believed an ASC would maintain are located during and after the

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emergency to allow for repatriation and providers. Some of these commenters to 18 months after hospitals. the continuation of regularly scheduled stated that these providers have the Furthermore, the commenter appointments. most capacity to implement these recommended an 18 to 24 month phase- While we pointed out JPATS as a tool requirements. A commenter in of emergency systems and a 24 to 38 for providers and suppliers, we note recommended that hospitals implement month phase-in for the training and that we indicated that we were not the requirements of the rule first, testing requirements. Another proposing a specific type of tracking followed by CAHs and other inpatient commenter recommended that facilities system that providers and suppliers provider types and LTC facilities. Other be allowed to comply with the initial must use. We also indicated that in the provider and supplier types would planning requirements within 2 years, proposed rule that a number of states follow thereafter. The commenter and then be allowed to comply with the have tracking systems in place or under recommended that CMS establish a subsistence and infrastructure development and the systems are period of non-enforcement for each requirements in years 3 and 4. available for use by healthcare providers implementation phase, while a Phase 1 The commenters varied in their and suppliers. We encourage providers evaluation is conducted and feedback is recommendations on the timeframe and suppliers to leverage the support given to other facilities. CMS should use for the implementation and resources available to them through Several commenters, including major date. These recommendations ranged local and national healthcare systems, hospital associations, disagreed with from 6 months to 5 years, with a few healthcare coalitions, and healthcare CMS’ proposal to implement all of the commenters recommending even longer organizations for resources and tools for requirements 1 year after the final rule periods. Some commenters noted that tracking patients. is published. The commenters noted applying a targeted approach, covering We have also reviewed our proposal that implementation of all the one or a subset of provider classes to to require ASCs, hospices, and HHAs to requirements after 1 year would be learn from implementation prior to track their staff and patients before and burdensome and costly to many extending the rule to all groups, would after an emergency. We discuss in detail facilities. In addition, a few commenters also allow a longer period of time for the comments we received specific to noted that certain facilities, mainly rural other provider/supplier types to prepare these providers and suppliers and and small facilities, may be at a for implementation. Furthermore, a revisions to their proposed tracking disadvantage because they have not commenter noted that a phased in requirement in their specific section participated in national emergency approach would help to alleviate the later in this final rule. preparedness planning efforts or cost burden on facilities that would because they lack the necessary need to create an emergency plan and B. Implementation Date resources to implement emergency train and test staff. We proposed several variations on an preparedness plans. Response: We appreciate the implementation date for the emergency A few commenters drew a distinction commenters’ feedback. We considered a preparedness requirements (78 FR between accredited and non-accredited phased-in approach in a number of 79179). Regarding the implementation facilities and recommended that ways. We looked at phasing in the date, we requested information on the hospitals implement the requirements implementation of various providers following issues: within a year or 2 after publication of and suppliers; and phasing in the • A targeted approach to emergency the final rule. Some of the commenters various standards of the regulation. We preparedness that would apply the rule noted that non-accredited facilities, concluded that this approach would be to one provider or supplier type or a CAHs, HHAs, and hospices, would need too difficult to implement, enforce, and subset of provider types, to learn from more time. Several of these commenters evaluate. Also, this would not allow implementation prior to requiring also stated that hospitals that need more communities to have a comprehensive compliance for all 17 types of providers time for implementation should be able approach to emergency preparedness. and suppliers. to propose to CMS a reasonable period However, we agree that there should be • A phased-in approach that would of time to comply. A few commenters a later implementation date for the implement the requirements over a stated that the emergency preparedness emergency preparedness requirements. longer time horizon, or differential time proposal is unlike the standards utilized However, we do not believe that a horizons for the different provider and by the TJC and that enforcement of these targeted or phased-in approach to supplier types. requirements should be at a later date implementation is appropriate. One Comment: Most commenters for both accredited and non-accredited thing we proposed and are now recommended that CMS set a later facilities. finalizing to address this concern is implementation date for the emergency Some commenters recommended that extending the implementation preparedness requirements. Some CMS give ASCs and FQHCs additional timeframe for the requirements to 1 year commenters recommended that we use time to come into compliance. A after the effective date of this final rule a targeted approach, whereby the rule commenter recommended that CMS set (see section section II, Provisions of the would be implemented first by one a later implementation date for the Proposed Rule and Responses to Public provider/supplier type or a subset of requirements and provide a flexible Comments, part B, Implementation provider/supplier types, with later implementation timeframe based on Date). We believe it is imperative that implementation by other provider/ provider type and resources. A few each provider thinks in terms broader supplier types, so they can learn from commenters stated that the than their own facility, and plan for prior implementation at other facilities. implementation timeline is too short for how they would serve similar and other Others recommended that CMS phase in rehabilitation facilities, long-term acute healthcare facilities as well as the whole the requirements over a longer time care facilities, LTC facilities, behavioral community during and surrounding an horizon. health inpatient facilities, and ICF/IIDs. emergency event. To encourage Many commenters recommended that A few commenters recommended that providers to develop a comprehensive CMS require implementation at CMS phase-in implementation on a and coordinated approach to emergency hospitals or LTC facilities first, so that standard-by-standard basis. A preparedness, all providers need to other facilities could benefit from the commenter recommended that LTC adopt the requirements in this final rule experience and lessons learned by these facilities implement the requirements 12 at the same time.

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Commenters have stated that many facilities already have established current accreditation standards. hospitals that are TJC-accredited are emergency preparedness plans, as Furthermore, the commenters noted that part of the Hospital Preparedness required by accrediting organizations. these four requirements would not Program (HPP) program, and those However, we acknowledge that there impose any additional burdens on hospitals that follow National Fire may be a significant amount of work hospitals. A few commenters Protection Association (NFPA®) that small facilities and those with acknowledged that some hospitals are standards, have already established limited resources will need to undertake not under the purview of an accrediting most of the emergency preparedness to establish an emergency preparedness agency and therefore may need up to 1 requirements set out in this rule. Based plan that conforms to the requirements year to implement the requirements. on CDC’s National Health Statistics set out in this regulation. However, we Response: We appreciate the Reports; Number 37, March 24, 2011, believe that prolonging the requirements commenters’ feedback. We agree with page 2 (NCHS–2008PanFluand in this final rule by 1 year will provide the commenters’ view that EP_NHAMCSSurveyReport_2011.pdf), sufficient time for implementation implementation of the requirements about 67.9 percent of hospitals had among the various facilities to meet the should occur 1 year after the final rule plans for all six hazards (epidemic- emergency preparedness requirements. is published for all 17 types of providers pandemic, biological, chemical, nuclear- We encourage facilities to engage and and suppliers. We believe that an radiological, explosive-incendiary, and collaborate with their local partners and implementation date for these natural incidents). Nearly all hospitals healthcare coalitions in their area for requirements that is 1 year after the (99.0 percent) had emergency response assistance. Facilities may also access effective date of this final rule will plans that specifically addressed ASPR’s TRACIE web portal, which is a allow all facilities to develop an chemical accidents or attacks, which healthcare emergency preparedness emergency preparedness plan that meets were not significantly different from the information gateway that helps all of the requirements set out within prevalence of plans for natural disasters stakeholders at the federal, state, local, these regulations. While we understand (97.8 percent), epidemics or pandemics tribal, non-profit, and for-profit levels why some commenters would want (94.1 percent), and biological accidents have access to information and these requirements to be implemented or attacks. However, we also believe that resources to improve preparedness, shortly after publication of the final other facilities will be ready to begin response, recovery, and mitigation rule, we also understand some implementation of these rules at the efforts. ASPR TRACIE, located at: commenters’ concerns about that same time as hospitals. We believe that https://asprtracie.hhs.gov/, is an timeframe. We believe that facilities will most facilities already have some basic excellent resource for the various CMS need a period of time after the final rule emergency preparedness requirements providers and suppliers as they seek to is published to plan, develop, and that can be built upon to meet the implement the enhanced emergency implement the emergency preparedness requirements set out in this final rule. preparedness requirements. We requirements in the final rule. We note that we have modified or encourage facilities to engage and Accordingly, we believe that 1 year is a eliminated some of our proposed collaborate with their local partners and sufficient amount of time for facilities to requirements for certain providers and healthcare coalitions in their area for meet these requirements. suppliers, as discussed later in this final technical assistance as they include Comment: A few commenters rule, which should ease concerns about local experts and can provide regional recommended that CMS include a implementation. Therefore, we believe information that can inform the provision that would allow facilities to that all affected providers and suppliers requirements as set forth. apply for additional time extensions or will be able to comply with these Comment: Some commenters waivers for implementation. A requirements 1 year after the final rule recommended that CMS implement all commenter recommended that CMS is published. of the emergency preparedness allow facilities to rely on their existing We do not believe a period of non- requirements 1 year after the final rule policies if the facility can demonstrate enforcement is appropriate as it will is published. Other commenters that the existing policies align with the further prolong the implementation of recommended that CMS implement the emergency preparedness plan necessary and life-saving emergency requirements as soon as the final rule is requirements and achieve a similar preparedness planning requirements by published or set an implementation date outcome. facilities. A later implementation date that is less than 1 year from the effective Response: We do not agree with will leave the most vulnerable patient date of this final rule. A few of these including a provision that will allow for populations and unprepared facilities commenters, including a major facilities to apply for extensions or without a valuable, life-saving beneficiary advocacy group, stated that waivers to the emergency preparedness emergency preparedness plan should an implementation should begin as soon as requirements. We believe that an emergency arise. We have not received practicable, or immediately after the implementation date that is beyond 1 comments that persuaded us that a later final rule is published and cautioned year after the effective date of this final implementation date for these against a later implementation date that rule for these requirements is requirements of more than 1 year is may leave facilities without important inappropriate and leaves the most beneficial or appropriate for providers emergency preparedness plans during vulnerable facilities and patient and suppliers or their patients. an emergency. populations without life-saving In response to commenters that Some of these commenters stated that emergency preparedness plans. opposed our proposal to implement the hospitals in particular already have However, we do understand that some requirements 1 year after the final rule emergency preparedness plans in place facilities, especially smaller and more was published and recommended that and are well equipped and prepared to rural facilities, may experience we afford facilities more time to implement the requirements set out in difficulties developing their emergency implement the requirements, we do not these regulations over the course of a preparedness plans. Therefore, we believe that the requirements will be year. Some commenters noted that most believe that setting an implementation overly burdensome or overly costly to hospitals are fully aware of the 4 date of 1 year after the effective date of providers and suppliers. We note, as we emergency preparedness requirements this final rule for these requirements have heard from many commenters, that set out in the proposed rule through will give these and other facilities

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sufficient time for compliance. As stated accompanied by extensive resources that consistency and conciseness in the earlier, we encourage facilities to form that providers and suppliers can use to IGs is critical in the evaluation process coalitions in their area for assistance in establish their emergency preparedness for providers and suppliers in meeting meeting these requirements. We also programs. In addition, CMS will create these emergency preparedness encourage facilities to utilize the many a designated Web site for the Emergency requirements. resources we have included in the Preparedness Rule at https:// Comment: A few commenters proposed and final rule. www.cms.gov/Medicare/Provider- recommended that CMS allow multiple We appreciate that some facilities Enrollment-and-Certification/Survey facility types that are administered by have existing emergency preparedness CertEmergPrep/index.html that will the same owner to obtain waivers of plans. However, all facilities will be house information for providers, specific requirements or have a single required to develop and maintain an suppliers and surveyors. The Web site multi-facility plan approved, if they can emergency preparedness plan based on will contain the link to the final rule collectively adopt a functionally an all-hazards approach and address the and will also include templates, equivalent strategy based on the four major elements of emergency provider checklists, sample emergency requirements that may apply to one of preparedness in their plan that we have preparedness plans, disaster specific their facility types. The commenters identified in this final rule. Each facility information and lessons learned. CMS note that operation of more than one will be required to evaluate its current will also be releasing an all-hazards facility type is not uncommon among emergency preparedness plan and FAQ document that will be posted to Tribal health programs. activities to ensure that it complies with Web site as well. We will also continue Response: Although we disagree with the new requirements. to communicate with providers and the commenter’s recommendation that Comment: A few commenters other stakeholders about these we allow multiple facility types that are recommended that CMS implement requirements through normal channels. administered by the same owner to enforcement of the final rule when the For example we will communicate with obtain implementation waivers of interpretive guidance (IG) is finalized by surveyors via Survey and Certification specific requirements, we agree that CMS. A few commenters noted that this memoranda and provide information to multiple facilities that are administered implementation data should include a facilities via, provider forums, press by the same owner, that effectively period of engagement with hospitals releases and Medicare Learning operate as an integrated health system, and other providers and suppliers, a Network publications. We continue to can have a unified emergency period to allow for the development and believe that setting a later preparedness program. We previously testing of surveyor tools, and a readiness implementation date for the discussed this final policy in the review of state survey agencies that is enforcement of these requirements will Integrated Health System section of this complete and publicly available. A leave the most vulnerable patient final rule. commenter recommended that facilities populations and unprepared facilities Comment: A commenter implement the requirements 5 years without valuable, life-saving emergency recommended that the states take the after the IGs have been published. preparedness plans should an lead on determining the timing of Another commenter recommended that emergency arise. One year is a sufficient implementation for various providers CMS phase-in implementation in terms amount of time for facilities to meet and suppliers. of enforcement and roll out, allowing these requirements. Response: We do not believe that time for full implementation and Comment: Several commenters, State governments or State agencies assistance to facilities and state including national and local should determine the timing of surveyors. organizations, and providers, supported implementation for facilities’ emergency A few commenters recommended that using a transparent process in the preparedness plans. While the State providers be allowed a period of time development of interpretive guidelines government will provide valuable where they are held harmless during a for state surveyors. They suggested resources during a disaster, CMS is transitional planning period, where consulting with industry experts, responsible for the implementation of providers may be allotted more time to healthcare organizations, accrediting the federal regulations for Medicare and plan and implement the emergency bodies and state survey agencies in the Medicaid certified providers and preparedness requirements. development of clear and concise suppliers. Furthermore, it will be Response: We disagree with the interpretation and application of the IGs difficult for survey agencies to monitor commenter’s recommendations that we nationwide. One provider suggested that the requirements in this rule if each should implement this regulation after CMS post the draft guidance State has different implementation the IGs have been published. electronically for a period of time and timelines. As stated previously, we Additionally, we disagree with the provide an email address for believe that most providers have basic recommendation that CMS phase in stakeholders to offer comments. emergency preparedness plans and enforcement or hold facilities harmless Furthermore, this provider suggested protocols and that they are capable of for a period of time while the that the guidance be pilot-tested and implementing the requirements within 1 requirements are being implemented, revised prior to adoption. year after the final rule is published. and we do not believe that it is Response: We thank the commenters After consideration of the comments appropriate to implement the CoPs after for their suggestions. In addition to the received, we are finalizing our proposal, the IGs are established. The IGs are CoPs/CfCs, IGs will be developed by without modification, to require subregulatory guidelines which CMS for each provider and supplier implementation of all of the establish our expectations for the types. We also note that surveyors will requirements for all providers and function states perform in enforcing the be provided training on the emergency suppliers 1 year after the final rule is regulatory requirements. Facilities do preparedness requirements so that published. not require the IGs in order to enforcement of the rule will be based on implement the regulatory requirements. the regulations set forth here. While C. Emergency Preparedness Regulations We note that CMS historically releases comments on the process for developing for Hospitals (§ 482.15) IGs for new regulations after the final the interpretive guidelines is outside the Our proposed hospital regulatory rule has been published. This EP rule is scope of this proposed rule, we agree scheme was the basis for all other

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proposed emergency preparedness hospitals have the capacity to respond Quality (AHRQ), to help hospital requirements as set out in the proposed in a timely and appropriate manner in planners and administrators make rule. Since application of the proposed the event of a natural or man-made important decisions about how to regulatory language for hospitals would disaster. Additionally, since Medicare- protect patients and healthcare workers be inappropriate or overly burdensome participating hospitals are required to and assess the physical components of for some facilities, we tailored specific evaluate and stabilize every patient seen a hospital when a natural or manmade proposed requirements to each in the emergency department and to disaster, terrorist attack, or other providers’ and suppliers’ unique evaluate every inpatient at discharge to catastrophic event threatens the situation. In the December 2013 determine his or her needs and to soundness of a facility. We also proposed rule we provided a detailed arrange for post-discharge care as provided additional guidance and discussion of each proposed hospital needed, hospitals are in the best resources for assistance with designing requirement, as well as resources that position to coordinate emergency and performing a hazard vulnerability facilities could use to meet the proposed preparedness planning with other assessment. requirements, a methodology to providers and suppliers in their In the proposed rule (78 FR 79094), establish and maintain emergency communities. we stated that in order to meet the preparedness, and links to guidance We proposed a new requirement proposed requirement for a risk materials and toolkits that could be used under § 482.15 that would require assessment at § 482.15(a)(1), we would to help meet the requirements. We hospitals to have both an emergency expect hospitals to consider, among encourage readers to refer to the preparedness program and an other things, the following: (1) proposed rule for this detailed emergency preparedness plan. To Identification of all business functions discussion. ensure that all hospitals operate as part essential to the hospitals operations that As previously discussed, many of a coordinated emergency should be continued during an commenters commented on the preparedness system, we proposed at emergency; (2) identification of all risks proposed regulations for hospitals, but § 482.15 that all hospitals establish and or emergencies that the hospital may indicated that their comments could maintain an emergency preparedness reasonably expect to confront; (3) also be applied to the additional plan that complies with both federal identification of all contingencies for provider and supplier types. Therefore, and state requirements. Additionally, which the hospital should plan; (4) where appropriate, we collectively refer we proposed that the emergency consideration of the hospital’s location, to hospitals and the other providers and preparedness plan be reviewed and including all locations where the suppliers as ‘‘facilities’’ in this section updated at least annually. As part of an hospital delivers patient care or services of the final rule. annual review and update, staff are or has business operations; (5) required to be trained and be familiar assessment of the extent to which 1. Risk Assessment and Emergency Plan with many policies and procedures in natural or man-made emergencies may (§ 482.15(a)) the operation of their facility and are cause the hospital to cease or limit Section 1861(e) of the Act defines the held responsible for knowing these operations; and (6) determination of term ‘‘hospital’’ and subsections (1) requirements. Annual reviews help to what arrangements with other hospitals, through (8) list requirements that a refresh these policies and procedures other healthcare providers or suppliers, hospital must meet to be eligible for which would include any revisions to or other entities might be needed to Medicare participation. Section them based on the facility experiencing ensure that essential services could be 1861(e)(9) of the Act specifies that a an emergency or as a result of a provided during an emergency. hospital must also meet such other community or natural disaster. We proposed at § 482.15(a)(2) that the requirements as the Secretary finds In keeping with the focus of the emergency plan include strategies for necessary in the interest of the health emergency management field, we addressing emergency events identified and safety of individuals who are proposed that prior to establishing an by the risk assessment. For example, a furnished services in the institution. emergency preparedness plan, the hospital in a large metropolitan city may Under the authority of 1861(e) of the hospital and all other providers and plan to utilize the support of other large Act, the Secretary has established in suppliers would first perform a risk community hospitals as alternate care regulations at 42 CFR part 482 the assessment based on using an ‘‘all- placement sites for its patients if the requirements that a hospital must meet hazards’’ approach. Rather than hospital needs to be evacuated. to participate in the Medicare program. managing planning initiatives for a However, we would expect the hospital Section 1905(a) of the Act provides multitude of threat scenarios all-hazards to have back-up evacuation plans for that Medicaid payments may be applied planning focuses on developing circumstances in which nearby to hospital services. Regulations at capacities and capabilities that are hospitals also were affected by the §§ 440.10(a)(3)(iii) and 440.140 require critical to preparedness for a full emergency and were unable to receive hospitals, including psychiatric spectrum of emergencies or disasters. patients. hospitals, to meet the Medicare CoPs to Thus, all-hazards planning does not At § 482.15(a)(3), we proposed that a qualify for participation in Medicaid. specifically address every possible hospital’s emergency plan address its The hospital and psychiatric hospital threat but ensures those hospitals and patient population, including, but not CoPs are found at §§ 482.1 through all other providers and suppliers will limited to, persons at-risk. We also 482.62. have the capacity to address a broad discussed in the preamble of the Services provided by hospitals range of related emergencies. proposed rule that ‘‘at-risk populations’’ encompass inpatient and outpatient care We stated that it is imperative that are individuals who may need for persons with various acute or hospitals perform all-hazards risk additional response assistance, chronic medical or psychiatric assessment consistent with the concepts including those who have disabilities, conditions, including patient care outlined in the National Preparedness live in institutionalized settings, are services provided in the emergency System, published by the United States from diverse cultures, have limited department. Hospitals are often the focal (U.S.) Department of Homeland English proficiency or are non-English points for healthcare in their respective Security, as well as guidance provided speaking, lack transportation, have communities; thus, it is essential that by Agency for Healthcare Research and chronic medical disorders, or have

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pharmacological dependency. response during a disaster or emergency approach. However, we understand that According to the section 2802 of the situation, including documentation of some providers use the term ‘‘hazard PHS Act (42 U.S.C. 300hh–1) as added the hospital’s efforts to contact such vulnerability assessment ‘‘(HVA) while by Pandemic and All-Hazards officials and, when applicable, its other providers and federal agencies use Preparedness Act (PAHPA) in 2006, in participation in collaborative and terms such as ‘‘all-hazards self- ‘‘at-risk individuals’’ means children, cooperative planning efforts. We stated assessment’’ or ‘‘all-hazards risk pregnant women, senior citizens and that we believed planning with officials assessment’’ to describe the process by other individuals who have special in advance of an emergency to which a provider will assess and needs in the event of a public health determine how such collaborative and identify potential gaps in its emergency emergency as determined by the cooperative efforts would achieve and plan(s). The providers and suppliers Secretary. In 2013, the Pandemic and foster a smoother, more effective, and discussed in this regulation should All-Hazards Preparedness more efficient response in the event of utilize an all-hazards approach to Reauthorization Act (PAHPRA) a disaster. Providers and suppliers must perform a ‘‘hazard vulnerability risk amended the PHS Act (http:// document efforts made by the facility to assessment.’’ While those providers and www.gpo.gov/fdsys/pkg/PLAW- cooperate and collaborate with suppliers that are more advanced in 113publ5/pdf/PLAW-113publ5.pdf) and emergency preparedness officials. emergency preparedness will be familiar added that consideration of the public Comment: A few commenters stated with some of the industry language, we health and medical needs of ‘‘at-risk that the term ‘‘all-hazards’’ is too broad believe that some providers/suppliers individuals’’ includes taking into and instead should be geared towards might not have a working knowledge of account the unique needs and possible emergencies in their the various terms; therefore, we used considerations of individuals with geographical area. The commenters language defining risk assessment disabilities. The National Response stated that the term ‘‘all-hazards’’ activities that would be easily Framework (NRF), the primary federal should be replaced with ‘‘Hazard understood by all providers and document guiding how the country Vulnerability Assessment’’ (HVA) to be suppliers that are affected by this responds to all types of disasters and more in line with the current emergency regulation and align with the national emergencies, includes in its description preparedness industry language that preparedness system and terminology. of ‘‘at-risk individuals’’ children, providers and suppliers are more Comment: We received many individuals with disabilities and others familiar. Commenters suggested that comments on our proposed changes to with access and functional needs; those CMS align the final rule with the require hospitals to develop an from religious, racial and ethnically current requirements of accreditation emergency plan utilizing an all-hazards diverse backgrounds; and people with organizations. Some commenters approach based on a facility- and limited English proficiency. We have requested clarification as to what an community-based risk assessment from included additional examples of at-risk HVA is and how it is performed. individuals, national and state populations, including definitions from Furthermore, commenters encouraged professional organizations, accreditation both PHS Act and NRF and have us to discuss the risks or emergencies organizations, individual and multi- expanded the definition to include that a hospital may expect to confront. hospital systems, and national and state examples used in the healthcare They recommended adding language to hospital organizations. industry. We have stated that the patient require that the hospital’s emergency Some commenters recommended population may not be limited to just plan be based on an HVA utilizing an adding ‘‘local’’ after applicable federal persons at-risk but may include, for all-hazards approach that identifies the and state emergency preparedness example, descriptions of patient emergencies that the hospital may requirements since some states already populations unique to their reasonably expect to confront. have local laws and regulations geographical areas, such as CMHCs and Response: In ‘‘An All Hazards governing their emergency management PRTFs. The definition of at-risk Approach to Vulnerable Populations activities. There was concern voiced populations provided in the regulation Planning’’ by Charles K.T. Ishikawa, that several of CMS’ proposals may text is to include all of the populations MSPH, Garrett W. Simonsen, MSPS, conflict or overlap with state and local discussed in the NRF and PHS Act Barbara Ceconi, MSW, and Kurt Kuss, laws and requirements. They definitions and are defined within the MSW (see https://apha.confex.com/ recommended that CMS should defer to individual providers and suppliers apha/135am/webprogram/ state and local standards where the included in this regulation. Paper160527.html), the researchers proposed CoPs and CfCs would overlap We also proposed at § 482.15(a)(3) described an all hazards planning with, be less stringent than, or conflict that a hospital’s emergency plan address approach as ‘‘a more efficient and with those standards. the types of services that the hospital effective way to prepare for Response: While we agree that the would be able to provide in an emergencies. Rather than managing responsibility for ensuring a emergency. In regard to emergency planning initiatives for a multitude of community-wide coordinated disaster preparedness planning, we also threat scenarios, all hazards planning preparedness response is under the state proposed at § 482.15(a)(3) that all focuses on developing capacities and and local emergency authorities, hospitals include delegations and capabilities that are critical to healthcare facilities will still be required succession planning in their emergency preparedness for a full spectrum of to perform a risk assessment, develop an plan to ensure that the lines of authority emergencies or disasters.’’ Thus, all- emergency plan, policies and during an emergency are clear and that hazards planning does not specifically procedures, communication plan, and the plan is implemented promptly and address every possible threat but train and test all staff to comply with appropriately. ensures that hospitals and all other the requirements in this final rule. We Finally, at § 482.15(a)(4), we proposed providers will have the capacity to disagree that we should defer to state that a hospital have a process for address a broad range of related and local standards for emergency ensuring cooperation and collaboration emergencies. In the proposed rule, we preparedness. Also, we do not believe with local, tribal, regional, state, or referred to a ‘‘hazard vulnerability risk that these requirements will conflict federal emergency preparedness assessment’’ as a ‘‘risk assessment’’ that with any state and local standards. officials’ efforts to ensure an integrated is performed using an all-hazards These emergency preparedness

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requirements are the minimal procedures, a communication plan, local communities. It is important to requirements that facilities must meet in testing and training plans. Regardless of keep facility staff updated and trained, order to be in compliance with the the various synonyms for the words as evidenced by policy and procedural emergency preparedness CoPs/CfCs. ‘‘program’’ or ‘‘plan’’, we expect a updates often occurring not only as a However, facilities have the option of facility to have a comprehensive result of an emergency that the facility including as part of their requirements, emergency preparedness program that experienced, but as has been noted in additional state, local and facility based addresses all of the required elements. the local and international news. For standards. In particular, the new An emergency program could be example, there are various infections requirements will require a coordinated implemented if an internal emergency and diseases, such as the Ebola outbreak and collaborative relationship with state occurred, such as a flood or fire in the in October, 2014, that required updates and local governments during a disaster. facility, or if a community emergency in facility assessments, policies and As such, we agree with the commenters occurred, such as a tornado, hurricane procedures and training of staff beyond that it is appropriate to add the word or earthquake. However, for the purpose the directly affected hospitals. The final ‘‘local’’ in the introductory paragraph of this rule, an emergency or a disaster rule requires that if a facility for the emergency preparedness is defined as an event that affects the experiences an emergency, an analysis requirements. For consistency within facility or overall target population or of the response and any revisions to the the regulation, we will also add the term the community at large or precipitates emergency plan will be made and gaps ‘‘local’’ to the communication plan the declaration of a state of emergency and areas for improvement should be requirements throughout the regulation. at a local, state, regional, or national addressed in their plans to improve the Comment: Some commenters level by an authorized public official response to similar challenges for any expressed concern that the term such as a Governor, the Secretary of the future emergencies. ‘‘emergency preparedness program’’ was Department of Health and Human Comment: Some commenters viewed discussed in the preamble and then the Services (DHHS), or the President of the the organization of the emergency plan regulation text used the term United States. in the proposed rule as separate from ‘‘Emergency preparedness plan,’’ and An emergency plan is one part of a the emergency preparedness policies they thought the use of both terms was facility’s emergency preparedness and procedures. Some hospitals have an confusing, a duplication of efforts and a program. The plan provides the emergency plan that consists of strain on limited resources. Some framework, which includes conducting emergency policies and procedures in a thought the plan included policies and facility-based and community-based risk single document that is updated procedures and training and did not assessments that will assist a facility in periodically. They recommended that refer to the term ‘‘program.’’ Some addressing the needs of their patient CMS recognize that the plan may commenters questioned whether the populations, along with identifying the represent the policies and procedures. proposed rule required hospitals to have continuity of business operations which Response: The format of the both an emergency preparedness will provide support during an actual emergency preparedness plan and program and an emergency emergency. In addition, the emergency emergency policies and procedures that preparedness plan and questioned if plan supports, guides, and ensures a a hospital or facility uses are at their documentation was required for both. facility’s ability to collaborate with local discretion. However, it must include all They recommended that CMS should emergency preparedness officials. As a the requirements included for the clearly stipulate in its standards that separate standard, facilities will be emergency plan and for the policies and only one document is required to required to develop policies and procedures. demonstrate compliance with the procedures to operationalize their Comment: A commenter questioned standards. emergency plan. Such policies and why mitigation was not included in the Some commenters believed that the procedures should include more risk assessment process as part of the emergency preparedness policies and detailed guidance on what their staff evaluation in reviewing the strategies procedures based on the emergency will need to develop and operationalize used during an emergency as related to plan and risk assessment could be a in order to support the services that are possible future similar events. The potential duplication of effort. They necessary during an actual emergency. commenter noted that FEMA provides recommended that CMS only require Comment: Some commenters stated resources, including grant programs, for healthcare organizations to document that the requirement to update the mitigation planning for communities. how they will meet the emergency policies and procedures annually was According to FEMA documents, preparedness standards in the excessive. Some suggested review only assistance from local emergency emergency preparedness plan, and not as needed, and several thought this management officials is available in require separate policies and requirement was burdensome. Some identifying hazards in their community, procedures. They stated that the concept commenters suggested that the plan and recommending options to address of an emergency preparedness plan is should only be reviewed after an them. A few commenters recommended equivalent to a policy, and the emergency event occurred. A few that we modify the regulation to include emergency preparedness plan states suggested that only the necessary mitigation. how the hospital will meet a standard. administrative personnel would need to Response: We understand the Response: We agree that the words review the plan according to their commenters’ concerns, however our ‘‘program’’ and ‘‘plan’’ are often used policy. Some commenters suggested that new emergency preparedness interchangeably. However, in this final weather-related emergencies be requirements focus on continuity of rule we use the word ‘‘program’’ to reviewed and updated seasonally or operations, not hazard mitigation, describe a facility’s comprehensive quarterly. which refers to actions to reduce to approach to meeting the health and Response: We disagree that an annual eliminate long term risk to people and safety needs of their patient population update is excessive or overly property from natural disasters. The during an emergency. We use the word burdensome. We believe it is good emergency plan requires facilities to ‘‘plan’’ to describe the individual business practice to review and evaluate include strategies for addressing the components of the program such as an at least annually for revisions that will identified emergency events that have emergency plan, policies and improve the care of patients, staff and been developed from the facility and the

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community-based risk assessments. Comment: Some commenters thought Other suggested categories, as set out in These strategies include addressing ‘‘The National Planning Scenarios’’ the comment, could be included in the changes that have resulted from discussed in the proposed rule were a individual facility’s assessments and evaluating their risk assessment process. good tool, but the risk assessment would not be limited to the examples We decided to not include specific developed at the organizational level listed in the proposed rule. mitigation requirements as part of the should be the driving force behind the As is often the case, in times of emergency plan and instead, base the emergency plan. It was recommended emergency, people seek assistance at plan on using an all-hazards approach that we clarify that the scenarios are general hospitals for such things as which can include mitigation activities merely variables that could be charging batteries for their medical to lessen the severity and impact a considered in addition to the equipment, and obtaining medical potential disaster or emergency can organization’s risk assessment of supplies such as oxygen, which they have on a health facility’s operation. potential local threats. need for their care. The commenters’ Facilities can choose to include hazard Response: We agree with the suggestion that community-wide mitigation strategies in their emergency commenters. In accordance with alternate locations be established to preparedness plan. However, we have § 482.15(a)(1), the hospital must develop handle these needs would need to be not made hazard mitigation a an emergency plan based on a risk arranged with their local emergency requirement. We refer commenters that assessment. As stated in the proposed preparedness officials. To facilitate that, are interested in hazard mitigation to rule, The National Planning Scenarios the proposed rule requires a process for the following resources for more were suggested as a possible tool that ensuring cooperation and collaboration information: facilities could consider in the with local, tribal, regional, state, and • National Mitigation Framework: development of their emergency plan federal emergency preparedness http://www.fema.gov/national- along with the development of the officials in order to ensure an integrated mitigation-framework. facility and community risk • response during a disaster or emergency FEMA Hazard Mitigation Planning: assessments. situation. Facilities are encouraged to http://www.fema.gov/hazard-mitigation- Comment: Some commenters believed participate in a local healthcare planning. the examples listed in the preamble coalition as it may provide assistance in Comment: Commenters agreed that a addressing patient populations, planning and addressing broader hospital should evaluate both including persons at-risk, were not community needs that may also be community-based and facility-based comprehensive enough and requested supported by local health department risks but did not believe that CMS that more categories be included. Some and emergency management resources. provided enough clarity about which stated that a ‘‘patient population’’ Facilities may include establishing entity is expected to conduct the included all patients; otherwise, they community-wide alternate locations in community-based risk assessment. It is would not be in a facility receiving their facility plan. Individual facilities unclear whether CMS would expect a treatment or care. The commenters would not be expected to take care of all hospital to conduct its own assessment suggested that at-risk populations the needs in the community during an outside of the hospital or rely on an (geriatric, pediatric, disabled, serious emergency. assessment developed by entities, such chronic conditions, addictions, or as regional healthcare coalitions, public mental health issues) served in all Comment: Several commenters stated health agencies, or local emergency provider settings receive similar that we did not require facilities to management. The commenters emphasis in guidance. A commenter evaluate strategies for addressing surge suggested that CMS allow hospitals to stated that the at-risk definition should capacity within the initial risk develop a hazard vulnerability risk be limited to those persons who are assessment. They suggested that we assessment by a different organization if identified by statute or who are assessed require facilities to address surge deemed adequate or conduct their own by the provider as being vulnerable due capacity in their emergency plans. assessment with input from key to physical and cognitive functioning Another commenter stated that facilities organizations as is consistent with TJC impairments. Some commenters were should develop specialized plans to and NFPA® standards. concerned that the wording of the address the needs of their patients with Response: We agree that a hospital regulation could create the expectation disabilities or who are medically could rely on a community-based that hospitals would be required to care dependent (for example, patients assessment developed by other entities, for all individuals in the community requiring dialysis or ventilator). such as their public health agencies, who had additional needs. They Response: We believe that an emergency management agencies, and believed community-wide planning emergency preparedness plan based on regional healthcare coalitions or in should ensure that alternate locations be an all-hazards risk assessment would conjunction with conducting its own established for such things as include plans for the potential of surge facility-based assessment. We would individuals dependent on medical activities during an emergency. The expect the hospital to have a copy of equipment that requires electricity for emergency plan should also consider this risk assessment and to work with recharging their equipment. Some the needs of the entire patient and staff the entity that developed it to ensure commenters suggested adding language populations. that the hospital emergency plan is in ‘‘of providing acute medical care and Comment: Commenters requested alignment. treatment in an emergency to describe clarification about what is meant by Comment: Some commenters the services that they will have the ‘‘type of services’’ the provider/ questioned if the proposed rule would ability to provide to their patient suppliers have the ability to provide in allow an aggregation of risk assessments population.’’ an emergency. for multiple sites. Response: In the proposed rule, Response: Based on the emergency Response: As discussed previously, several types of patient populations situation and the facility’s available we are allowing integrated plans for were described as at-risk. More resources, a facility would need to integrated health systems. Please refer to examples would have required an assess its capabilities and capacities in the ‘‘Integrated health Systems’’ section exhaustive list and even then, not all order to determine the type of care and of this final rule for further information. categories would have been included. treatment that could be offered at that

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time based on its emergency Response: Facilities are required to hurricanes in the Gulf States in 2005 preparedness plan. have an emergency preparedness plan revealed that hospitals were forced to Comment: Some facilities questioned that addresses the usual patient meet basic subsistence needs for how they could include a process for population of the community the community evacuees, including visitors ensuring cooperation and collaboration hospital serves. In addition, certified and volunteers who sheltered in place, with local, tribal, regional, state, and Medicare providers and suppliers are resulting in the rapid depletion of federal emergency preparedness required to provide meaningful access subsistence items and considerable officials’ efforts to ensure an integrated to Limited English Proficient (LEP) difficulty in meeting the subsistence response during a disaster or emergency persons under the provider agreement needs of patients and staff. Therefore, situation. Some commenters stated that and supplier approval requirement we proposed that a hospital’s policies they already had this requirement in (§ 489.10), to comply with Title VI of the and procedures also address how the their states’ regulations and were Civil Rights Act of 1964. Title VI subsistence needs of patients and staff already familiar with the process. Many requires Medicare participants to take that were evacuated would be met commenters believed the term reasonable steps to ensure meaningful during an emergency. ‘‘ensuring’’ was too onerous for access to their programs and activities At § 482.15(b)(1)(ii) we proposed that providers and suppliers and CMS did by LEP persons. the hospital have policies and not take into consideration that the State Comment: A commenter stated that procedures that address the provision of and local emergency officials also had the risk assessment should include the alternate sources of energy to maintain: responsibilities. A commenter suggested availability of emergency power or a (1) Temperatures to protect patient adding language: ‘‘with the goal of plan for ensuring emergency power with health and safety and for the safe and implementing an integrated response the owner of a building in which the sanitary storage of provisions; (2) during a disaster or emergency facility operates when a facility is not emergency lighting; and (3) fire situation, including documentation of owned by the provider. detection, extinguishing, and alarm the hospital’s efforts to contact such Response: It is the responsibility of systems. At § 482.15(b)(1)(ii)(D), we officials and when applicable, its the healthcare provider that is renting a proposed that the hospital develop participation in collaborative and facility to discuss issues of ensuring that policies and procedures to address the cooperative planning efforts.’’ Several they can continue to provide healthcare provisions of sewage and waste disposal commenters recommended replacing during an emergency if the structure of including solid waste, recyclables, the word ‘‘ensure’’ with the words the building and its utilities are chemical, biomedical waste, and waste ‘‘strive for.’’ Some believed this impacted. We would expect providers to water. requirement was important but with include this in their risk assessment. As At § 482.15(b)(2), we proposed that limited funds available, implementation discussed in the next section, we the hospital develop policies and would be excessively burdensome. require facilities to develop policies and procedures regarding a system to track Response: As noted previously, some procedures to address alternate sources the location of staff and patients in the commenters stated that they were of energy. hospital’s care, both during and after an already familiar with the process for After consideration of the comments emergency. We stated that it is ensuring cooperation and collaboration we received on the proposed rule, we imperative that the hospital be able to with various levels of emergency are finalizing our proposal with the track a patient’s whereabouts, to ensure preparedness officials. Providers and following modifications: adequate sharing of patient information suppliers must document efforts made • Revising the introductory text of with other facilities and to inform a by the facility to cooperate and § 482.15 by adding the term ‘‘local’’ to patient’s relatives and friends of the collaborate with emergency clarify that hospitals must also patient’s location within the hospital, preparedness officials. While we are coordinate with local emergency whether the patient has been transferred aware that the responsibility for preparedness systems. to another facility, or what is planned in ensuring a coordinated disaster • Revising § 482.15(a)(4) to remove respect to such actions. We did not preparedness response lies upon the the word ‘‘ensuring’’ and replacing the propose a requirement for a specific state and local emergency planning word ‘‘ensure’’ with ‘‘maintain.’’ type of tracking system. We believed authorities, we have stated previously in that a hospital should have the this rule that providers and suppliers 2. Policies and Procedures (§ 482.15(b)) flexibility to determine how best to must document efforts made by the We proposed at § 482.15(b) that a track patients and staff, whether it uses facility to cooperate and collaborate hospital be required to develop and an electronic database, hard copy with emergency preparedness officials. implement emergency preparedness documentation, or some other method. Since some aspects of collaborating with policies and procedures based on the However, we stated that it is important various levels of government entities emergency plan proposed at § 482.15(a), that the information be readily may be beyond the control of the the risk assessment proposed at available, accurate, and shareable provider/supplier, we have stated that § 482.15(a)(1), and the communication among officials within and across the these facilities must include in their plan proposed at § 482.15(c). We emergency response system, as needed, emergency plan a process for proposed that these policies and in the interest of the patient and cooperation and collaboration with procedures be reviewed and updated at included in their policies and local, tribal, regional, state, and federal least annually. procedures. emergency preparedness officials. We proposed at § 482.15(b)(1) that a We proposed at § 482.15(b)(3) that a Comment: A commenter suggested hospital’s policies and procedures hospital have policies and procedures in that CMS take into account potential would have to address the provision of place to ensure safe evacuation from the language barriers that may occur in rural subsistence needs for staff and patients, hospital, which would include areas during an emergency. The whether they evacuated or sheltered in consideration of care and treatment commenters recommended that CMS place, including, but not limited to, at needs of evacuees; staff responsibilities; include a requirement for a formal § 482.15(b)(1)(i), food, water, and transportation; identification of interpreter to interact with non-English medical supplies. We noted that the evacuation location(s); and primary and speaking patients during an emergency. analysis of the disaster caused by the alternate means of communication with

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external sources of assistance. We officials. We proposed this requirement are discussed later in this final rule. We proposed at § 482.15(b)(4) that a for inpatient providers only. We stated also proposed that all providers and hospital have policies and procedures to that we would expect that state or local suppliers review and update their address a means to shelter in place for emergency management officials might policies and procedures at least patients, staff, and volunteers who designate such alternate sites, and annually. We received a few comments remain in the facility. We indicated that would plan jointly with local facilities on this issue. we would expect that hospitals include on issues related to staffing, equipment Comment: A few commenters in their policies and procedures both and supplies at such alternate sites. This indicated that a requirement for annual the criteria for selecting patients and requirement encourages providers to updates to the policies and procedures staff that would be sheltered in place collaborate with their local emergency is the most feasible for facilities. A and a description of how they would officials in proactive planning to allow commenter stated that annual updates ensure their safety. an organized and systematic response to are not only reasonable, but also We proposed at § 482.15(b)(5) that a assure continuity of care even when necessary in order to ensure that hospital have policies and procedures services at their facilities have been emergency plans and procedures are that would require a system of medical severely disrupted. Under section 1135 adequate and current. Other documentation that would preserve of the Act, the Secretary is authorized to commenters stated that a stricter patient information, protect the temporarily waive or modify certain requirement, for example of bi-annual confidentiality of patient information, Medicare, Medicaid, and Children’s updates, would be burdensome and and ensure that patient records are Health Insurance Program (CHIP) unrealistic for facilities to meet. Still secure and readily available during an requirements for healthcare providers to other commenters stated that the emergency. In addition to the current ensure that sufficient healthcare items requirement to update policies and hospital requirements for medical and services are available to meet the procedures annually was excessive and records located at § 482.24(b), we needs of individuals enrolled in these burdensome. Some suggested review on proposed that hospitals be required to programs in an emergency area (or an ‘‘as needed’’ basis instead. Some ensure that patient records are secure portion of such an area) during any suggested that weather-related and readily available during an portion of an emergency period. Under emergencies be reviewed and updated emergency. We indicated that such an 1135 waiver, healthcare providers seasonally or quarterly. policies and procedures would have to unable to comply with one or more Response: We appreciate the feedback be in compliance with Health Insurance waiver-eligible requirements may be from commenters and we agree that Portability and Accountability Act reimbursed and exempted from requiring annual updates is effective (HIPAA) Rules at 45 CFR parts 160 and sanctions (absent any determination of and the most realistic expectation of 164, which protect the privacy and fraud or abuse). Additional information facilities. We do not agree that an security of an individual’s protected regarding the 1135 waiver process is annual update is excessive or overly health information. We proposed at provided in the CMS Survey and burdensome. It is important to keep § 482.15(b)(6) that facilities have Certification document entitled, facility staff updated and trained on policies and procedures in place to ‘‘Requesting an 1135 Waiver’’, located emergency policies and procedures address the use of volunteers in an at: http://www.cms.gov/About-CMS/ regardless of whether the facility has emergency or other emergency staffing Agency-Information/H1N1/downloads/ experienced an actual emergency. For strategies, including the process and requestingawaiver101.pdf. example, various infections and role for integration of state or federally Comment: A commenter stated that diseases, such as the Ebola outbreak in designated healthcare professionals to we should clarify that if a hospital is October 2014, have required updates in address surge needs during an destroyed in an emergency but facility assessments, policies and emergency. personnel are present with the relevant procedures, and training of staff to We proposed at § 482.15(b)(7) that expertise, then personnel may function ensure the health and safety of their hospitals have a process for the within their scope of practice in a patients and employees. Facilities are development of arrangements with other makeshift location. free to update as needed but at least hospitals and other facilities to receive Response: We agree that if a hospital annually. patients in the event of limitations or is destroyed in an emergency, the Comment: Most commenters believed cessation of operations at their facilities, medical personnel of that hospital that providing for the subsistence needs to ensure the continuity of services to should be able to function within their of patients and staff was appropriate but hospital patients. This requirement scope of practice in an alternate care site only if sheltering in place. If patients would apply only to facilities that to provide valuable medical care. The were evacuated, the receiving facility provide continuous care and services for hospital and other inpatient providers should be responsible for those needs. individual patients; therefore, we did should address this issue in their Some commenters believed that not propose this requirement for policies and procedures. These community organizations, and local transplant centers, CORFs, OPOs, providers, in accordance with section emergency management agencies should clinics, rehabilitation agencies, and 1135 of the Act, should have policies provide for subsistence needs when public health agencies that provide and procedures for the provision of care patients are sent to the receiving outpatient physical therapy and speech- and treatment at an alternate care site facilities. Some commenters questioned language pathology services, or RHCs/ identified by emergency management other agencies’/organizations’ FQHCs. officials. We would expect that state or requirements and how that would We also proposed at § 482.15(b)(8) local emergency management officials impact their current requirements; some that hospital policies and procedures would plan jointly with local facilities questioned whether certain amounts would have to address the role of the on issues related to staffing, equipment were sufficient and many were hospital under a waiver declared by the and supplies at such alternate sites. concerned about the burden with many Secretary, in accordance with section The comments we received on our facilities operating on limited budgets. 1135 of the Act, for the provision of care proposed requirement for hospitals to Other commenters suggested we should and treatment at an alternate care site develop and implement emergency require facilities to have a minimum identified by emergency management preparedness policies and procedures store of provisions to meet the needs of

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their patient or resident populations for be a good practice to prepare for these hospitals are in the best position to 72 to 96 hours. The commenters stated ‘‘community individuals,’’ we are not coordinate emergency preparedness that we should clarify the amount of requiring it under § 482.15(b)(1). The planning with other providers and time to provide subsistence during and provision on subsistence needs applies suppliers in their communities. Relief after an emergency. Other commenters only for staff and patients. staff may be unable to get to the hospital stated that we should not mandate Comment: Commenters suggested that thus requiring staff to remain at the specific subsistence needs and we add ‘‘pharmaceuticals or hospital for indefinite periods of time. quantities and a few commenters stated medications’’ to provisions of food, We disagree with removing the that we should delete the requirement water and medical supplies. requirement for facilities to make the for a hospital to provide subsistence in Response: We agree with the necessary plans to provide food, water, the event of an evacuation. commenters’ suggestion and have added medical supplies, and subsistence needs Response: We would first like to point pharmaceuticals to the list of for the patients, staff, and volunteers out that we are requiring certain subsistence needs in the regulation text. who remain in the facility. As we have facilities to have policies and Comment: A commenter questioned noted previously, the policy only procedures to address the provision of why supplies, such as personnel, power, requires that the hospital have policies subsistence in the event of an water, and finances, are not addressed to provide for subsistence needs, which emergency. This does not mean that in relation to subsistence needs in the we believe are not unduly burdensome. facilities would need to store provisions proposed rule. The commenter noted We are not setting minimum themselves. We agree that once patients that the requirements do not include requirements or standards for these have been evacuated to other facilities, how these supplies will be sustained provisions in hospitals. it would be the responsibility of the during emergency situations. Comment: A commenter receiving facility to provide for the Response: We have included recommended that we require the patients’ subsistence needs. Local, state requirements that facilities develop and electronic monitoring of fire and regional agencies and organizations maintain emergency preparedness extinguishers. The commenter stated often participate with facilities in policies and procedures that address that this requirement would address the addressing subsistence needs, subsistence needs for staff and patients widespread non-compliance of fire emergency shelter, etc. Secondly, we are at § 482.15(b)(1). However, we believe extinguisher code regulations. Another not specifying the amount of the rule allows flexibility so that commenter disagreed with the use of subsistence that must be provided as we facilities can determine how they will electronic monitoring of fire believe that such a requirement would acquire provisions and use them for the extinguishers, arguing that retrofitting be overly prescriptive. Facilities can needs of patients and staff. fire extinguishers with this technology best manage this based on their own Comment: A commenter stated that would be costly. facility risk assessments. We disagree we should delete the requirement we Response: This recommendation is with setting a rigid amount of proposed at § 482.15(b)(4) that a not within the scope of this regulation. subsistence to have on hand at any hospital must have policies and For additional information we refer given time in the event of an emergency. procedures to address a means to shelter readers to our current Life Safety Code Based on our experience with inpatient in place for patients, staff, and regulations (for hospitals, § 482.41(b)). healthcare facilities to allow each volunteers who remain in the facility. Comment: In addition to the general facility the flexibility to identify the The commenter inquired about what a comments discussed earlier that we subsistence needs that would be hospital should do with the patients received regarding our proposal for required during an emergency, mostly that they decide are not going to be certain providers and suppliers to track likely based on level of impact, is the sheltered in place and rescue crews staff and patients during and after an most effective way to address cannot make it to the hospital to remove emergency, we also received a few subsistence needs without imposing them. comments specific to the tracking undue burden. Response: Plans should be made to requirement for hospitals. Many Comment: In response to a solicitation shelter all patients in the event that an questioned the complexity of the of public comments in the proposed evacuation cannot be executed. We state tracking documentation and what rule, almost all the facility commenters at § 482.15(b)(1) that provisions should information would be needed. Some stated that they did not see subsistence be made for patients and staff whether commenters stated that patient tracking preparations for individuals residing in they evacuate or shelter in place. within the hospital should be the larger community as their However, with advance notice in event distinguished from tracking patients responsibility. The commenters stated of an emergency, it may be medically outside of the hospital, in the hospital’s that local and state emergency necessary for some of the patient care, or whether they are located at an management personnel along with civic population to be evacuated in advance. alternate care site operated by the organizations such as the Red Cross During an emergency, often the hospital hospital. Moving and tracking of should be responsible for meeting these may be the only available resource to patients may also be the responsibility needs. In addition, the cost for the patients and are the focal points for of an entity other than the hospital, such facilities to provide these services to the healthcare in their respective as state and emergency management community would be unsustainable. communities. It is essential that officials and the hospitals may not know Some commenters interpreted the hospitals have the capacity to respond the destination of the individuals. Some proposed regulation text to not only in a timely and appropriate manner in commenters requested clarification include responsibility for patients and the event of a natural or man-made regarding what we mean by a ‘‘system staff in the facility, but also individuals disaster. Since Medicare participating to track.’’ in the community. hospitals are required to evaluate and Commenters noted that the facility’s Response: We agree with the stabilize every patient seen in the tracking system may not be compatible commenters and did not mean to emergency department and to evaluate with the hospital’s IT system. If the suggest that facilities are also every inpatient at discharge to system lacks interoperability, it becomes responsible for individuals in the determine his or her needs and arrange difficult to share information across the community. While we believe it would for post-discharge care as needed, emergency management system.

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Commenters suggested that CMS change activities for the efficient and effective would be burdensome to their overall the current language and instead add ‘‘a use of limited resources. fiscal operation. Many commenters hospital would be required to have a Comment: Some commenters believed multiple IT systems would be process to locate staff and track the questioned our proposal to shelter incompatible. Some commenters location of patients in the hospital’s care volunteers and voiced concern about pointed out that if power were lost, they both during and throughout the their legal responsibilities. A would lose the ability to copy records emergency.’’ Some commenters commenter stated that it would be and use computers to access patient interpreted the proposed requirement to challenging for some facilities to records. Some facility commenters include the hospital’s responsibility of provide shelter for patients, staff, and stated that they use paper documents tracking the whereabouts of patients in volunteers who remain in the facility. (pre-printed forms) that document outpatient facilities (assuming they are Commenters expressed concern in relevant patient information and attach part of the hospital). These commenters response to our proposal that hospitals’ them to patients during an evacuation. recommended that CMS remove this ‘‘shelter-in-place’’ policies include both A commenter believed that some requirement. the criteria for selecting patients and facilities would find it difficult to Response: We appreciate the staff that would be sheltered, and a provide a system of medical commenters’ feedback and have description of how they would ensure documentation that would ensure that clarified our expectations. As indicated their safety. Some commenters stated medical records were complete, previously, we have removed ‘‘after the that this appeared to lack significant confidential, secure, and readily emergency’’ from the regulation text. evidence of being an effective policy. available. The same commenters stated Furthermore, we are revising the The commenters questioned what we that it would also be challenging for regulation text to clarify that we would expected a hospital to do with the them to share medical documentation expect facilities to track their on-duty patients that the hospital decides not to and relevant patient information with staff and sheltered patients during an shelter in place, if rescue crews could other healthcare facilities to ensure emergency and document the specific not make it to the hospital to remove continuity of healthcare and treatment location and name of where a patient is them. Other commenters believed during an emergency. relocated to during an emergency (that hospitals should prepare to shelter in Response: We are not requiring EHRs is, to another facility, home, or alternate place all patients, staff, and visitors. The as part of the medical record means of shelter, etc.). As we stated in commenters recommended that CMS documentation requirements. Medicare- the proposed rule, we did not propose modify its proposal to permit hospitals and Medicaid-participating facilities are a requirement for a specific type of to decide which patients and staff to in varying stages of EHR adoption, and tracking system. By ‘‘system to track’’ shelter. therefore, many would be unable to Response: We agree that sheltering in we mean that facilities will have the electronically share relevant patient care place can be a challenge to facilities. flexibility to determine how best to information with other treating However, the emergency plan requires track patients and staff, whether they healthcare facilities during an strategies for addressing this issue in the emergency. However, we do expect utilize an electronic database, hard copy facility risk assessment. As such, we facilities to be able to provide a means documentation, or some other method. disagree with revising our policy for to preserve and protect patient records We would expect that the information sheltering in place. We require facilities and ensure that they are secure, in order would be readily available, accurate, to have a means to shelter in place for to provide continuity in the patient’s and shareable among officials within patients, staff, and volunteers who care and treatment. We would expect and across the emergency response remain in the facility. Based on its facilities’ plans to address how a system, as needed, in the interest of the emergency plan, a hospital could decide provider, in the event of an evacuation, patient. to have various approaches to sheltering would release patient information, as Comment: Some commenters some or all of its patients, staff and permitted under 45 CFR 164.510 of the questioned who would assign visitors. The plan should take into HIPAA Privacy Rule. This section of the evacuation locations outside the facility account the available beds in the area to HIPAA Privacy Rule sets out ‘‘Uses and if it was determined necessary. If which patients could be transferred in disclosures requiring an opportunity for internal, they believe the provider or the event of an emergency. For example, the individual to agree or to object.’’ supplier should decide. if it is risky or the emergency affects Facilities should establish an effective Response: Decisions about evacuation available sites for transfer or discharge, communication system, in accordance locations within a facility should be then the patients would remain in the with the HIPAA Privacy Rule, that made by the provider or supplier. If facility until it was safe to transfer or could generate timely, accurate patients must be evacuated outside of discharge. Also, we would expect information that can be disseminated, as the facility, a joint decision could be providers and suppliers to have policies permitted, to family members and made by the facility and the local health and guidelines for sheltering volunteers others. Facilities should also consider department and emergency management and visitors during an emergency. including in their communication plan officials. Facilities must determine their policies information on what type of patient Comment: Several commenters stated based on the emergency and the types information is releasable and who is that the same transportation services of visitors/volunteers that may be authorized to release this information may be planned for use by several present during and after an emergency. during an emergency. Additional facilities and that planning should Comment: Some commenters information and resources regarding the consider multiple options in the event questioned if the system of medical application of the HIPAA Privacy Rule of an evacuation. documentation has to be electronic. during emergency scenarios can be Response: We agree with the Some stated that they already have this located at: http://www.hhs.gov/ocr/ commenters. We suggest that facilities in place in their facilities. Many stated privacy/hipaa/understanding/special/ consider identifying potential that electronic health records (EHRs) are emergency/. redundant transportation options and not used universally and, if required, Comment: Some commenters stated collaborate with healthcare coalitions to would be unrealistic to put into that the development of arrangements better inform and assist in planning operation for this requirement and with hospitals or other providers and

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suppliers to receive patients in the event who would decide what are acceptable life-sustaining care and treatment. We of limitation of services, so as to assure types of energy sources (such as agree with the commenters that facilities continuity of services, was unrealistic, propane or battery-operated) and what should include as part of their risk due to limited availability of resources service needs could be met, such as assessment how specific needs will be (that is, other hospitals or facilities may operating rooms, emergency met to maintain temperatures to protect be experiencing limitation of services or departments, and surgical and intensive patient health and safety. We are not there are no other providers or suppliers care units. Several commenters requiring facilities to upgrade their in the area). recommended that CMS state how long electrical systems, but after their review Response: We understand that during a hospital would be expected to provide of their facility risk assessment, an emergency other available healthcare alternative or backup power. facilities may find it prudent to make resources may be strained, but the Response: Alternate sources of energy any necessary adjustments to ensure development of arrangements in depend on the resources available to a that patients’ health and safety needs collaboration with other facilities to facility, such as battery-operated lights, are met and that facilities maintain safe receive patients is necessary in order to propane lights, or heating, in order to and sanitary storage areas for provide the continued needed care and meet the needs of a facility during an provisions. treatment for all patients. If arranged emergency. We would encourage Comment: Many commenters resources are unavailable during an facilities to confer with local health expressed concern about their emergency, then the facility should use department and emergency management perception that they would be held the available resources in its officials, as well as and healthcare responsible for maintaining sewage and community. Facilities are encouraged to coalitions, to determine the types and waste disposal in their facility during participate with its local healthcare duration of energy sources that could be and after an emergency event. The coalition to gain a broader available to assist them in providing commenters thought that such matters understanding of other facilities and care to their patient population during were outside their scope of potential resources, both facility and an emergency. As part of the risk responsibilities. Some thought our community, that may be available assessment planning, facilities should expectations were unclear. Some during an emergency. determine the feasibility of relying on commenters noted that energy is not Comment: Some commenters stated these sources and plan accordingly. always required for these processes. A that any alternate care site should be Comment: Some commenters stated commenter stated that in some identified either by the provider or that alternate sources of energy to emergencies, infrastructure could be supplier alone or in conjunction with maintain temperatures for patient health damaged, backup power could be the emergency management officials. A and safety may not be realistic to unavailable, local water and sewage few commenters questioned the legal achieve because their emergency responsibilities of the staff working at systems may already have pre-planned services could be limited or unavailable, the alternate care site. Some areas of need, such as use in the or their hazardous waste disposal commenters questioned the effect of a emergency department, operating contractors could be unavailable. Other waiver on their reimbursement process. rooms, intensive care units, and commenters recommended that CMS Many questions and concerns about necessary medical life sustaining needs, require hospitals to have backup plans staffing responsibilities were related to such as ventilators, oxygen and if their primary waste-handling who would make staffing decisions and intravenous equipment, and cardiac operations become disabled or who would pay alternate care site monitoring equipment. In clinical care disrupted, which could include storing salaries. Some commenters stated that areas of facilities, patients may have to waste in a secure area until the facility the staff could not be spared from their be moved, fans may have to be brought arranged removal. The commenters also facilities even in emergency in or temperature control may be recommended that hospitals identify circumstances. outside of the facility’s control entirely. and assess the risks in their risk Response: Health department and Temperatures to maintain safe and assessments relating to their facility’s emergency management officials, in sanitary storage of provisions may not wastewater system and describe in their collaboration with facility staff, would be viable due to limited backup power. emergency plan how they would be responsible for determining the need Commenters recommended that these address specific scenarios in which to establish an alternate care site as part requirements be aligned with the sewage might become a problem. of the delivery of care during an current NFPA® standards. Commenters Several commenters stated that the emergency. The alternate care site staff recommended that we require hospitals treatment of sanitary sewage on site would be expected to function in the to describe in their emergency plans would possibly require the installation capacity of their individual licensure how they will mitigate specific of an onsite sewage treatment plant if and best practice requirements and scenarios, such as if they are unable to the municipal system were disrupted, laws. Professional staff normally carries maintain temperatures or refrigeration. which would be impossible for inner malpractice insurance and facilities also In addition, they review their current city facilities due to limited physical have malpractice insurance, which emergency power capacity and assess space. Commenters stated that the would also include coverage for their whether upgrades should be made. The proposed rule seemed to require that employees. Decisions regarding staff commenters stated that CMS’ proposed waste continue to be disposed of in a responsibilities would be determined rule could be interpreted as increasing disaster, and that the proposed rule was based on the facility- and community- requirements on electrical systems and too broad. based assessments and the type of require upgrades to those systems, Response: We agree with the services staff could provide. This which could be costly to accomplish. commenters’ recommendation that regulation does not address payment Response: We understand that facilities should identify and assess issues. protocols for emergency distribution of their sewage and wastewater systems as Comment: Many commenters stated energy within a facility may have part of their facility-based risk that they would be unable to provide or already been set to accommodate such assessment and make necessary plans to obtain alternative sources of energy priorities as emergency lighting, fire maintain these services. We are not during an emergency. They questioned detection, alarm systems, and providing requiring onsite treatment of sewage but

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that facilities make provisions for both federal and state law. We proposed would best be applied only to facilities maintaining necessary services. that hospitals be required to review and that provide continuous care to patients, Comment: A commenter stated that update the communication plan at least as well as to those facilities that take CMS should revise the requirement at annually. During an emergency, it is responsibility for and have oversight § 482.15(b)(6) to state ‘‘use of health care critical that hospitals, and all providers/ over or both, care of patients who are volunteers’’ to clarify that this suppliers, have a system to contact homebound or receiving services at requirement is different from the appropriate staff, patients’ treating home. requirement for the use of ‘‘general’’ physicians, and other necessary persons We proposed at § 482.15(c)(6) to volunteers. in a timely manner to ensure require hospitals to have a means of Response: The intent of this continuation of patient care functions providing information about the general requirement is to address any throughout the hospital and to ensure condition and location of patients under volunteers. We believe that in an that these functions are carried out in a the facility’s care, as permitted under 45 emergency a facility or community safe and effective manner. Updating the CFR 164.510(b)(4) of the HIPAA Privacy would need to accept volunteer support plan annually would facilitate effective Rule. Section 164.510(b)(4), ‘‘Use and from individuals with varying levels of communication during an emergency. disclosures for disaster relief purposes,’’ skills and training and that policies and Providers and suppliers are to have establishes requirements for disclosing procedures should be in place to facility contact information for federal, state, patient information to a public or this support. Health care volunteers tribal, regional, or local emergency private entity authorized by law or by would be allowed to perform services preparedness staff and other sources of its charter to assist in disaster relief within their scope of practice and assistance. Patient care must be well efforts for purposes of notifying family training and non-medical volunteers coordinated across healthcare providers, members, personal representatives, or would perform non-medical tasks. As and with state and local public health certain others of the patient’s location or such, we disagree with limiting this departments and emergency systems to general condition. We did not propose requirement to just medical volunteers. protect patient health and safety in the prescriptive requirements for how a After consideration of the comments event of a disaster. hospital would comply with this we received on the proposed rule, we At § 482.15(c)(1), we proposed that requirement. Instead, we stated that we are finalizing our proposal with the the communication plan include names would allow hospitals the flexibility to following modifications: and contact information about staff, • develop and maintain their own system. Revising § 482.15(b)(1)(i) to add that entities providing services under Lastly, we proposed at § 482.15(c)(7) hospitals must have policies and arrangement, patients’ physicians, other that a hospital have a means of procedures that address the need to hospitals, and volunteers. We stated providing information about the stock pharmaceuticals during an that, during an emergency, it is critical hospital’s occupancy, needs, and its emergency. that hospitals have a system to contact • ability to provide assistance, to the Revising § 482.15(b)(2) to remove appropriate staff, patients’ treating authority having jurisdiction or the physicians, and other necessary persons the requirement for hospitals to track Incident Command Center, or designee. staff and patients after an emergency in a timely manner to ensure Comment: Many commenters and clarifying that in the event staff and continuation of patient care functions expressed support for the proposal to patients are relocated, hospitals must throughout the hospital and to ensure require hospitals to develop and document the specific name and that these functions are carried out in a maintain an emergency preparedness location of the receiving facility or other safe and effective manner. We proposed communication plan that complies with location for sheltered patients and on- at § 482.15(c)(2) to require hospitals to both federal and state law and is duty staff who leave the facility during have contact information for federal, reviewed and updated annually. A the emergency. state, tribal, regional, or local emergency • Revising § 482.15(b)(5) to change preparedness staff and other sources of commenter noted that the proposed the phrase ‘‘ensures records are secure assistance. requirements are consistent with TJC and readily available’’ to ‘‘secures and We proposed at § 482.15(c)(3) to standards. The commenter noted that maintain availability of records.’’ require that hospitals have primary and while they believe that these • Revising § 482.15(b)(5) and (7) to alternate means for communicating with requirements can be met by larger remove the word ‘‘ensure.’’ the hospital’s staff and federal, state, institutions with ease, smaller • Adding a new § 482.15(f) to allow a tribal, regional, or local emergency institutions may have more difficulties. separately certified hospital within a management agencies. A few commenters disagreed with the healthcare system to elect to be a part We also proposed at § 482.15(c)(4) to proposal to require that of the healthcare system’s emergency require that hospitals have a method for communications plans have contact preparedness program. sharing information and medical information for all staff physicians, documentation for patients under the families, patients, and contractors. A 3. Communication Plan (§ 482.15(c)) hospital’s care, as necessary, with other commenter stated that this would An effective and well maintained healthcare facilities to ensure continuity require an additional full time communication plan will facilitate of care. equivalent (FTE) staff member. Another coordinated patient care across We proposed at § 482.15(c)(5) that commenter stated that it would be healthcare providers, and with state and hospitals have a means, in the event of challenging and overly burdensome to local public health departments and an evacuation, to release patient maintain a current contact list, emergency systems to protect patient information as permitted under 45 CFR especially for volunteers. health and safety in the event of a 164.510 of the HIPAA Privacy Rule. A commenter stated that it could be disaster. For a hospital to operate Thus, hospitals would need to have a difficult for children’s hospitals to effectively in an emergency situation, communication system in place capable maintain a comprehensive list of people we proposed at § 482.15(c) that of generating timely, accurate and entities, as required for a hospital’s hospitals be required to develop and information that could be disseminated, communication plan. The commenter maintain an emergency preparedness as permitted, to family members and gave an example of a hospital that communication plan that complies with others. We believe this requirement maintains a listing for most managers

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and above, but not for all general staff expect that facilities would consider will share clinical documentation is and volunteers. using the following devices: unrealistic. The commenter noted that Response: We appreciate the • Pagers. many HHAs still operate with paper commenters’ support and feedback. We • Internet provided by satellite or documentation, are stand-alone disagree with the commenters who non-telephone cable systems. facilities, and do not coordinate with suggested that it would be overly • Cellular telephones (where other healthcare systems or with other burdensome for hospitals to maintain a appropriate). Facilities can also carry local facilities. The commenter stated current contact list. As a best practice, accounts with multiple cell phone that surveyors should be aware that the most hospitals maintain an up-to-date carriers to mitigate communication capability of facilities to communicate list of their current staff for staffing failures during an emergency. patient-specific clinical documentation directories and human resource • Radio transceivers (walkie-talkies). • to other facilities in the local healthcare management. In addition, most Various other radio devices such as system is likely to be limited. hospitals have procedures or systems in the NOAA Weather Radio and Amateur Response: We disagree with the Radio Operators’ (ham) systems. place to handle their roster of • commenters’ statement that hospitals volunteers. We believe that a hospital Satellite telephone communication should not or cannot have a method for would have a comprehensive list of system. sharing information and medical their staff, given that these lists are Comment: A few commenters documentation for patients during an necessary to maintain operations and expressed support for the proposed emergency or disaster, as necessary. We formulate a payroll. In addition, we language that requires that the hospital’s believe that hospitals should have an continue to believe that it is critically communication plan include a method established system of communication important that hospitals have a way to for sharing information and medical that would ensure that patient care contact appropriate physicians treating documentation for patients under the information could be disseminated to patients, and entities providing services hospital’s care, as necessary, with other other providers and suppliers in a under arrangement, other hospitals, and healthcare facilities to ensure continuity timely manner, as needed, during an volunteers during an emergency or of care. The commenters noted that the emergency or disaster. disaster event to ensure continuation of proposed language is flexible and does We have seen the importance of patient care functions throughout the not require the use of any specific formulating this type of communication hospital and to ensure continuity of technology. The commenters plan in the past to ensure continuity of care. recommended that CMS continue to use care. Sharing patient information and Furthermore, we clarify that we are flexible language in the final rule and documentation was found to be a not requiring hospitals to include in not require hospitals to use any specific significant problem during the 2005 their communication plan contact technology. The commenters noted that, hurricanes and flooding in the Gulf information for the families of staff, or in many instances, hospitals would Coast states. In 2011, the ability to share the families of patients who are not share information through paper-based information during the Joplin, Missouri directly involved in the patient’s care, documentation. tornado both electronically and via hard or contractors not currently providing Response: We appreciate the copy helped patient evacuations and services under arrangement. commenters’ support. We reiterate that continuity of care. In addition, during Comment: A commenter § 482.15(c)(4) requires that facilities Hurricane Sandy in 2012, some recommended that CMS scale back the have a method for sharing information hospitals reported receiving evacuated requirement for an alternate means of and medical documentation for patients patients from a nearby hospital with communication, in order to allow under the hospital’s care, as necessary, little or no medical documentation facilities more time to evaluate existing with other healthcare facilities to ensure (HHS OIG, Hospital Emergency communications technology and to continuity of care. As the commenters Preparedness and Response During gradually build toward a more pointed out, we are not requiring, nor Super Storm Sandy. September 2014). integrated and collaborative system as are we endorsing, a specific digital In some cases, electronic medical resources allow. storage or dissemination technology. records were unavailable and only oral Response: We do not believe that Furthermore, we note that we are not patient histories could be provided. scaling back the requirements for an requiring facilities to use EHRs or other This lapse in medical documentation is alternate means of communication to be methods of electronic storage and detrimental to patient care. Therefore, used during an emergency would be dissemination. In this regard, we we continue to believe that hospitals beneficial to hospitals and their acknowledge that many facilities are should include in their communication patients. As we have learned over the still using paper-based documentation. plan a method for sharing information years, landline telephones are often However, we encourage all facilities to and medical documentation for patients inoperable for an extended period of investigate secure ways to store and under the hospital’s care, as necessary, time during and after disasters. Cell disseminate medical documentation with other healthcare providers to phones also can be unreliable and are during an emergency to ensure ensure continuity of care. We encourage often without reception during an continuity of care. hospitals and other providers and emergency event, or are completely Comment: A few commenters suppliers to engage in coalitions in their unusable due to a lack of cellular objected to the requirement that area for assistance in effectively meeting coverage in certain remote and rural hospitals have a method for sharing this requirement. areas. Therefore, it is appropriate and information and medical documentation We clarify that we are not requiring vitally important for hospitals to have for patients under the hospital’s care. A the use of EHRs within this regulation some alternate means to communicate commenter specifically objected to the and we understand that some hospitals with their staff and federal, state and sharing of medical records with other and other providers and suppliers may local emergency management agencies health systems. The commenter stated still be using paper medical records. during an emergency. While we are not that it is difficult to share this However, we encourage these facilities endorsing a specific alternate information with facilities that have to consider the use of alternative means communication system or requiring the different systems. Another commenter of storing patient care information, to use of certain specific devices, we stated that the expectation that hospitals ensure that medical documentation is

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preserved and easily disseminated evacuation, to release patient • http://transition.fcc.gov/pshs/ during an emergency or disaster. information as permitted under current emergency-information/guidelines/ Comment: A commenter law. health-care.html • recommended that the requirements Response: In response to this public http://www.dhs.gov/government- pertaining to a method or means of comment, we are clarifying that § 482.12 emergency-telecommunications- sharing information include timelines service-gets (c)(5) requires that the hospital must • for submission of such documentation have a means, in the event of an http://www.phe.gov/preparedness/ to other healthcare providers or other evacuation, to release patient planning/hpp/reports/documents/ entities as described in proposed information as permitted under 45 CFR capabilities.pdf § 482.15(c)(4) through (6). 164.510(b)(1)(ii), which establishes Comment: Several commenters Response: We do not believe that it is permitted uses and disclosures of expressed concern about the proposed appropriate to include suggested protected health information to notify a provisions that would require hospitals timelines for facilities to share family member, a personal information and medical documentation to include a means of providing representative of the individual, or for patients under the hospital’s care in information about the general condition another person responsible for the these emergency preparedness and location of patients under the individual’s location, general condition, requirements. Instead, we believe that facility’s care as permitted under 45 or death. We are also clarifying in the facility should determine the CFR 164.510(b)(4). Commenters noted appropriate timeline for the parallel provisions of the regulation that that hospitals should already have dissemination of information to other RNHCIs, ASCs, hospices, PRTFs, PACE HIPAA compliance plans in place that providers and pertinent entities. We organizations, LTC facilities, ICF/IID would address emergency situations. have included the language ‘‘as facilities, CAHs, CMHCs, and dialysis They also noted that some states have necessary’’ in the regulations to allow facilities must have a means, in the stricter privacy laws than HIPAA and, facilities flexibility to share information event of an evacuation, to release therefore, the commenters and medical documents as needed to patient information as permitted under recommended that the regulatory ensure continuity of care for patients 45 CFR 164.510(b)(1)(ii). language include a phrase that states during an emergency. Facilities should establish an effective that facilities should comply with Comment: A few commenters communication system, in accordance applicable state privacy laws in addition expressed concern about the language with the previously referenced to HIPAA. used in the preamble, which states that provision of the HIPAA Privacy Rule A few commenters questioned if the hospitals would share comprehensive that could generate timely, accurate HIPAA privacy laws would be relaxed patient care information. The information that can be disseminated, as or waived during an emergency. A commenters noted that the term permitted, to family members and commenter requested clarification on ‘‘comprehensive information’’ is not others. Facilities should also consider privacy rules in emergency situations defined and suggested that CMS focus including in their communication plan across all providers and suppliers, first on relevant information that enables a information on what type of patient responders, and community aid care provider to determine what information is releasable and who is organizations. medical services and treatments are authorized to release this information Response: Section 482.15(c) states appropriate for each patient. during an emergency. that hospitals must develop and maintain an emergency preparedness Response: We agree with the Comment: A commenter expressed communication plan that complies with commenters that facilities should share concern over the financial burden that both federal and state law. This phrase relevant patient information to ensure smaller institutions may incur when is applicable to the requirement that continuity of care for a patient in implementing a system for sharing hospitals should provide a means of situations where a provider must information. The commenter noted that providing information about the general evacuate. In addition, we note that this burden may be reduced as more condition and location of patients under while we did not propose to require that institutions move towards EHRs. the facility’s care; therefore, hospitals providers share comprehensive patient Therefore, the commenter are required to comply with both 45 care information, we believe that recommended a phased-in approach to CFR 164.510(b)(4) and all pertinent state relevant patient information includes, implementing this requirement. but is not limited to, the patient’s laws. Several commenters presence or location in the hospital; Response: We understand the recommended that the regulatory personal information the hospital has commenter’s concern about the language include a phrase that states collected on the patient for billing or potential financial burden that smaller that facilities should comply with demographic analysis purposes, such as facilities may incur. However, we have applicable state privacy laws in addition name, age, address, and income; or not specified a method or a system for to HIPAA. We note that the requirement information on the patient’s medical sharing patient information. These as currently written will require condition. Although we have not regulations enable facilities to develop hospitals to comply with all pertinent specified requirements for timelines for procedures that best meet their needs state laws, including pertinent state delivering patient care information, we and take into account their facility’s privacy laws, and that it is not necessary would expect that facilities would resources. Additionally, we believe that to add additional language. provide patient care information to many facilities already have basic HIPAA requirements are not receiving facilities during an emergency preparedness plans, which suspended during a national or public evacuation, within a timeframe that may reduce the cost of implementation. health emergency. However, the HIPAA allows for effective patient treatment We encourage facilities to engage in Privacy Rule specifically permits certain and continuity of care. healthcare coalitions in their area for uses and disclosures of protected health Comment: A commenter requested assistance. We also refer facilities to the information in emergency clarification on the proposal that following Web sites for more circumstances and for disaster relief requires hospital communication plans information about emergency purposes, as described in HHS guidance to include a means, in the event of an communication planning: at http://www.hhs.gov/hipaa/for-

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professionals/special-topics/emergency- plan. Interpretive guidance for this procedure for sharing information and preparedness/index.html. In addition, regulation and subsequent surveyor medical documentation, when under section 9 of the Project Bioshield training will be completed after the necessary, with other healthcare Act of 2004 (Pub. L. 108–276), which publication of this rule. facilities to ensure continuity of care. added paragraph 1135(b)(7) to the Act, Comment: A few commenters stated Comment: A few commenters the Secretary of HHS may waive that Health Information Exchange (HIE) discussed the requirements for penalties and sanctions against facilities networks are in varying stages of communication plans as set out in the that do not comply with certain development and, in some areas, no HIE most recent NFPA® 99–2012 guidelines. provisions of the HIPAA Privacy Rule if network is available. Therefore, some of Citing the NFPA® 99–2012 requirements the President declares an emergency or these commenters suggested that CMS for communication plans, the a disaster and the Secretary declares a work with the Office of the National commenters noted that CMS’ proposed public health emergency. Coordinator (ONC) to support policies communication plan requirements are Facilities and their legal counsel that accelerate the development of a too general by comparison. The should review the HIPAA Privacy Rule robust infrastructure for HIE networks. commenters stated that this carefully before deciding to share Response: We appreciate this generalization would make it harder to patient information. We refer readers to feedback and agree with the verify that a facility’s plan meets the the following resources for more commenters. CMS continues to work emergency preparedness requirements information on the application of the with the ONC to support and promote and would make the verification of HIPAA Privacy Rule during an the adoption of health information adherence to these requirements tedious emergency: technology and the nationwide and subjective. Furthermore, the development of HIE to improve • http://www.hhs.gov/hipaa/for- commenters stated that the proposal healthcare. While we are not mandating professionals/privacy/laws- mimics the current standard in the the use of EHRs through this rule, we ® regulations/ NFPA 99–2012, and may cause encourage facilities to consider the • http://www.hhs.gov/sites/default/ misinterpretation and conflict as the meaningful use of certified EHR files/emergencysituations.pdf regulations change over time. technology to improve patient care. A commenter stated that some key • http://www.hhs.gov/ocr/privacy/ HHS has initiatives designed to communication planning items are not hipaa/understanding/special/ encourage HIE among all healthcare included in the proposed rule and are emergency/index.html providers, including those who are not better described in the standard NFPA® Comment: A few commenters stated eligible for the Electronic Health Record 99, ‘‘Health Care Facilities Code, 2012 that the language set out in the proposed (EHR) Incentive Programs, and are edition.’’ rule describing requirements for a designed to improve care delivery and Response: We appreciate the hospital’s communication plan would coordination across the entire care commenters’ feedback about the NFPA® have broad implications for EHRs. The continuum. Our revisions to this rule 99–2012 edition. We issued a final rule commenters noted that this regulation are intended to recognize the advent of on May 4, 2016 entitled ‘‘Medicare and could result in facilities being deemed electronic health information Medicaid Programs; Fire Safety non-compliant for reasons outside of technology and to accommodate and Requirements for Certain Health Care their control, since, as they argue, the support adoption of Office of the Facilities’’ (81 FR 26871), to adopt the industry does not have the ability to National Coordinator for Health 2012 editions of NFPA® 101, ‘‘Life electronically transfer or share patient Information Technology (ONC) certified Safety Code,’’ and NFPA® 99, ‘‘Health information and medical documentation health IT and interoperable standards. Care Facilities Code.’’ We refer readers in a disaster with other healthcare We believe that the use of such to that final rule for a discussion of facilities in a HIPAA-compliant manner. technology can effectively and these requirements. Response: We appreciate the efficiently help facilities and other We do not believe that we have been commenters concerns regarding the providers improve internal care delivery overly prescriptive in our difficulties that facilities could practices, support the exchange of communication plan requirements. experience with their EHRs’ operability important information across care team Facilities are afforded the flexibility to with non-EHR healthcare facilities members (including patients and include more detailed and stringent during an emergency. We acknowledge caregivers) during transitions of care, communication plan policies in their that EHR technology is in varying stages and enable reporting of electronically emergency preparedness plan, as long as of development throughout the provider specified clinical quality measures they meet the minimum requirements and supplier communities and (eCQMs). For more information, we described here. understand the ramifications of this direct stakeholders to the ONC guidance Comment: A commenter when patient information and necessary for EHR technology developers serving recommended that CMS explicitly medical documentation needs to be providers ineligible for the Medicare include social media in the communicated during an emergency. and Medicaid EHR Incentive Programs communications plan requirements. The If a facility using EHRs experiences an titled ‘‘Certification Guidance for EHR commenter noted that social media has emergency where patient information Technology Developers Serving Health recently proven to be an essential tool needs to be communicated to a Care Providers Ineligible for Medicare for communication during disasters. receiving facility that does not support and Medicaid EHR Incentive Response: We appreciate the an EHR system, alternate methods such Payments.’’ (http://www.healthit.gov/ commenter’s feedback. While we as paper documentation or faxed sites/default/files/generalcertexchange acknowledge the importance of other information can be used. Facilities are guidance_final_9-9-13.pdf). types of electronic communication and encouraged to explore alternate means In addition, we encourage facilities to encourage facilities to utilize technology of communicating this information. engage in healthcare coalitions in their when developing a well-organized The rule requires a method of sharing area in effort to identify local best communication plan, which may patient information and medical practices and potential examples that include communication through social documentation to ensure continuity of may assist them in developing media, the regulations list the minimum care as part of their communication communication plans that include a requirements for a provider’s

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communication plan. We have not requirement that a hospital have a Response: We understand the prescribed specific communication method for sharing information and commenter’s concerns about failures in plans within our regulations and have medical documentation for patients public communication systems and we instead allowed hospitals the flexibility under the hospital’s care, facilities may agree that hospitals should include to formulate and maintain their own choose to store or back up electronic processes that would allow for communication plans. We would expect information within and outside the communication with staff, care facilities to choose appropriate ways to geographic area if they determine that providers, families, and others who may communicate with patients or the this is the best option for their facility not have alternative forms of technology community as a whole. to maintain their ability to provide such as HAM and satellite systems. Comment: A commenter information that can ensure continuity However, hospitals should be as well recommended that CMS encourage the of patient care during a disaster. prepared as possible ahead of an integration of the hospital in the Facilities may find this strategy useful emergency or disaster as they attempt to community Joint Information Center, during an emergency if the facility loses mitigate any potential system failures. and focus on not only the logistics and power or needs to be evacuated. We believe that our proposal to require infrastructure of communication, but However, although we believe that it is that hospitals develop and maintain a the actual management of messages and a best practice to have an alternate communication plan that includes a act of communicating. storage location for medical means for communicating with hospital Response: We encourage hospitals to documentation, we are not mandating staff, and with federal, state, tribal, develop an effective communication that facilities store information within regional, and local emergency plan that contains contact information and outside the geographic area where management entities, appropriately for local emergency preparedness staff the hospital is located. We encourage helps to prepare hospitals to and to also have a primary and alternate facilities to consider all options that are communicate with the appropriate means for communicating with local available to them to protect their emergency management officials during emergency management agencies. A medical documentation to ensure an emergency or disaster. We encourage hospital’s communication plan, for continuity of care should an emergency hospitals to consider all types of example, may have specific protocols or disaster occur. alternate communication systems and to for communicating with a community Comment: A commenter develop a communication plan that emergency operations center or joint recommended that CMS require includes procedures on how these information center, and if the hospital facilities to address recovery of alternate communication plans are used, so chooses, the plan can contain operations planning in emergency and and who uses them. Hospitals may seek procedures on how to formulate, communications plans. information on the National manage, and deliver messages. As Response: We agree that it is Communication System (NCS), which previously stated, the hospital can important for hospitals and other offers a wide range of National Security exceed the minimum standards providers and suppliers to consider and Emergency Preparedness described here. recovery of operations while planning communications services, the Comment: A few commenters for an emergency. However, we note Government Emergency requested clarification on the definition that the scope and focus of the Telecommunications Services (GETS), of the term ‘‘geographic area’’, as used emergency preparedness requirements the Telecommunications Service in the requirement for the backup of in this regulation are on continuity of Priority (TSP) Program, Wireless electronic information to be stored operations during and immediately after Priority Service (WPS), and Shared within and outside of the geographic an emergency. Hospitals and other Resources (SHARES) High Frequency area where the hospital is located. providers and suppliers may choose, as Radio Program at http://www.hhs.gov/ Another commenter stated that it is a best practice, to incorporate recovery ocio/ea/National%20Communication unclear how a facility could of operations in their emergency plans %20System/ (click on ‘‘services’’). demonstrate that any backup system but we note that this is not a Comment: A commenter stated that would be sufficiently ‘‘geographically requirement that needs to be met in state, regional and local emergency remote’’ from the region and stated that order to be in compliance with these operations have required the ‘‘Chain of CMS should clearly define the conditions of participation. We refer Command’’ process. The commenter expectations of this section. The readers to the resources noted in this notes that facilities should have the commenter also noted that an final rule on recovery of operations. flexibility to adhere to the state/regional expectation that facilities establish data Comment: A commenter noted that Chain of Command and that farms in extremely remote areas of when large scale events occur, public clarification is needed to define the service was excluded from the ICR communication systems are scope of the expectation of the proposed burden calculations. overburdened and ineffective. rule. The commenters also expressed Furthermore, the commenter noted that Response: As previously stated, concern about the language in the although hospitals will have alternate § 482.15(c) states that hospitals must proposed rule which stated that means to communicate through develop and maintain an emergency ‘‘electronic information would be technology such as HAM radio, 800 preparedness communication plan that backed up both within and outside the megahertz (MHz)/ultrahigh frequency complies with both federal and state geographic area where the hospital was (UHF) radio, satellite systems, and law. We are not prescribing, nor are we located’’ and questioned what exactly Government Emergency mandating, that hospitals abide by a constitutes enough of a geographic Telecommunications Service (GETS), certain ‘‘Chain of Command’’ process. separation to meet the intent of the these technologies will not be readily As long as hospitals are complying with proposed language. available to the persons that the hospital federal and state law, hospitals are given Response: We clarify that we are not may be trying to reach. The commenter the flexibility in these rules to comply requiring facilities to utilize EHRs or recommended that CMS focus on the with a ‘‘Chain of Command’’ process electronic systems that would require hospital establishing processes to that is utilized at their state or local external backup, off-site storage readily communicate with staff, care level. We do encourage hospitals to facilities, or data farms. In meeting the providers, suppliers, and family. understand National Incident

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Management System (NIMS) which if deemed appropriate for that facility communication plan, the onus should provides a common emergency response and patient population. be with the state and not the hospital to structure and suggested Comment: A commenter stated that determine authorized levels of communications processes that will communications planning should interoperability with all healthcare better support and enable integration include equipment interoperability, partners. with local, tribal, regional, state and redundancy, communications, and Response: We understand the federal response operations. We would cyber security provisions. The commenter’s concerns about the also expect hospitals that choose to commenter also stated that the primary potential burden on hospitals. However, comply with a ‘‘Chain of Command’’ and alternate communication systems we believe that hospitals have the process would include such procedures for hospitals should include ability to maintain an emergency in their communication plan. interoperability coordination, planning preparedness communication plan Comment: A commenter and testing with interdependent while working in conjunction with the recommended that CMS include healthcare systems, their supporting federal, state, tribal, regional or local language in § 482.15(c)(6) requiring the critical infrastructure systems, and emergency preparedness staff. We disclosure of patient information to state critical supply chains. expect that hospitals will be able to and local emergency management Response: We agree with the communicate and coordinate with other agencies. commenter that hospitals should healthcare facilities in order to protect Response: We believe that hospitals consider security, equipment patient health and safety during an should have a means of providing interoperability, and redundancy in emergency or disaster event. We information, as permitted under the their emergency preparedness plan. We continue to support hospitals and other HIPAA Privacy Rule, 45 CFR 164.510, in also agree with the statement that facilities engaging in healthcare the event of an evacuation and that a hospitals should plan for and test coalitions in their area for assistance hospital should have a means of interoperability of their communication broadening awareness and collaboration providing information about the general systems during drills and exercises. as well as in identifying best practices condition and location of patients under However, we are allowing facilities that can assist them to effectively meet the facility’s care as permitted under 45 flexibility in how they formulate and this requirement. CFR 164.510(b)(4). However, we do not operationalize the requirements of the Comment: A commenter stated that believe that it is appropriate to include communication plan. We have not annual review requirements are a dated in these regulations a mandatory included specific requirements on cyber approach to ensuring that policies are requirement that hospitals specifically security and redundancy. However, we kept up-to-date. The commenter disclose patient information to state and encourage facilities to assess whether recommended that CMS eliminate the local health department and emergency their specific facility can benefit from annual review requirements and tie the management agencies. Hospitals may such plans. review and revision to the testing release patient information during an Comment: A few commenters process and periodic risk assessment. evacuation or emergency disaster, in requested that CMS provide clarification Response: We disagree with the compliance with federal and state laws. on which federal laws are referenced in commenter’s statement that annual Comment: A commenter the proposed rule in regards to the review requirements are dated. We recommended that CMS include the proposed communication plan. The believe that hospitals are best prepared phrase ‘‘and in accordance with state commenters wanted to ensure that to act appropriately and swiftly during law’’ in § 482.15(c)(6). facilities are aware of, and comply with, an emergency or disaster event with an Response: We disagree with the all applicable federal regulations. A updated communication plan. Updating commenter that an additional phrase commenter expressed concern that, the hospital’s communication plan, at ‘‘and in accordance with state law’’ without knowing the federal statutes least annually will account for changes should be included in § 482.15(c)(6). We referenced it would be difficult for in staff that have occurred during the believe that language at § 482.15(c), hospitals to assess whether compliance year at the hospital and at the federal, which states that the hospital must would be burdensome. A commenter state, tribal, regional or local level. In develop and maintain an emergency stated that clarifying this statement addition, hospitals can update their preparedness communication plan that would assist facilities to determine the communication plans at any time to complies with both federal and state real cost of compliance. incorporate the most recent best law, sufficiently addresses concerns Response: As with all CoPs, we expect practices and lessons learned. about hospital compliance with state facilities to adhere to additional federal We note that this standard includes laws. and state laws that are applicable and the minimum requirements for Comment: A commenter necessary to provide quality healthcare. reviewing and updating a hospital’s recommended that CMS consider For example, some states might have emergency preparedness including non-healthcare facilities in more stringent requirements for their communication plan. Hospitals can the communication plan, such as child healthcare facilities and personnel and review and update their communication care programs and schools, where we would expect the facilities to comply plan more frequently than annually if children with disabilities and other with those requirements. Our CoPs do they choose to do so. Currently, many access and functional needs may be not preclude facilities from establishing hospitals frequently update their contact sheltering in place. requirements that are more stringent. list to account for staffing changes. Response: We do not believe that it is We encourage facilities to determine Therefore, we continue to believe that appropriate to require hospitals to what federal, state, and local laws apply hospitals should review and update include other providers of services, such to their specific facility’s locations and their communication and emergency as child care programs and schools, in develop plans that comply with these preparedness plan at least annually. their communication plan in these federal, state, and local emergency Comment: A commenter expressed conditions of participation. However, preparedness requirements. support for the proposed we have allowed facilities the flexibility Comment: A commenter stated that communication plan for hospitals but and the discretion to include such while most hospitals meet the stated that an annual update of staff providers in their communication plans requirements in the proposed contact information is not frequent

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enough. The commenter recommended 4. Training and Testing (§ 482.15(d)) preparedness training and testing that CMS modify this standard to We proposed at § 482.15(d) that a program. Comment: In general, most require that staff information be hospital develop and maintain an commenters supported our proposal to maintained more often than annually, emergency preparedness training and require hospitals to develop an such as quarterly or semi-annually. The testing program. We proposed to require emergency preparedness training and commenter notes that within 1 year, key the hospital to review and update the testing program. We received a few staff and individual responsibilities that training and testing program at least general comments about the are needed during an emergency can annually. requirement. A commenter stated that change. We stated that a well-organized, Another commenter recommended training and testing would heighten effective training program must include that facilities reevaluate and update provider awareness with regard to the providing initial training in emergency their emergency and communication facilities’ limitations and ultimately preparedness policies and procedures. plan within 180 days of a specific ameliorate some of the negative effects We proposed at § 482.15(d)(1) that emergency event. of a disaster on continuity of care hospitals provide such training to all Response: We thank the commenters through quicker decision making. A few new and existing staff, including any for their suggestion. We agree that staff commenters expressed concerns about information at hospitals changes individuals providing services under the financial burden that the frequently and note that, as a best arrangement and volunteers, consistent development of training and testing practice, hospitals may choose to with their expected roles, and maintain programs would impose on their consider updating their communication documentation of such training. In facilities. Some agreed that state and plan more frequently than annually. addition, we proposed that hospitals local governments may be able to However, we are requiring that hospitals provide training on emergency provide training resources for some update their communication plan at procedures at least annually and ensure rural and smaller hospitals and least annually, which allows for that staff demonstrate competency in facilities; however, some commenters hospitals to update their emergency these procedures. pointed out that many states and local contact list quarterly, semi-annually or Regarding testing, we proposed at governments are facing considerable more frequently if they choose to do so § 482.15(d)(2), to require hospitals to staffing and budget cuts, limiting their and still maintain compliance with the conduct drills and exercises to test their resources. In addition, a few requirements of this standard. We emergency plans. We proposed at commenters provided suggestions for encourage hospitals to assess whether it § 482.15(d)(2)(i) to require hospitals to how we could improve the discussion of is appropriate to update their contact participate in a community mock our proposed requirement within the lists annually or more frequently than disaster drill at least annually. If a preamble section of the proposed rule. annually. community mock disaster drill is not Response: We thank the commenters In regards to the recommendation that available, we proposed that hospitals for their support and feedback. We agree facilities reevaluate and update their should conduct individual, facility- that overall emergency preparedness emergency and communication plan based mock disaster drills at least planning will have a positive impact on within 180 days of a specific emergency annually. However, we proposed at facilities, suppliers, and the populations event, we note that the emergency § 482.15(d)(2)(ii) that if a hospital that they serve. We recognize the time preparedness CoPs require that experiences an actual natural or man- and financial impact that the hospitals and other providers and made emergency that requires activation development of training and testing suppliers review and update their plans of the emergency plan, the hospital programs will impose on facilities, but at least annually at a minimum. We are would be exempt from engaging in a believe that the benefits of heightened also requiring, at § 482.15(d)(2)(iv), that community or individual, facility-based awareness, improved processes, and hospitals analyze the hospital’s mock disaster drill for 1 year following increased safety and preparedness will response to, and maintain the actual event. ultimately outweigh the burden. documentation of, all drills, tabletop We proposed at § 482.15(d)(2)(iii) to Comment: Many commenters exercises, and emergency events, and require hospitals to conduct a paper- expressed concerns about the varying revise the hospital’s emergency plan, as based tabletop exercise at least levels of emergency preparedness needed. Facilities can choose to review annually. We indicated that the tabletop experience of hospitals as well as other and update their plans more frequently exercise could be based on the same or provider and supplier types. than annually at their own discretion. a different disaster scenario from the Commenters stated that some providers, After consideration of the public scenario used in the mock disaster drill hospitals in particular, may have a comments we received, we are or the actual emergency. We proposed trained disaster response or planning finalizing our proposal, with the to define a tabletop exercise as a group person on staff. These commenters following modifications: discussion led by a facilitator, using a wanted to know how we will take this • Revising § 482.15(c) by adding the narrated, clinically-relevant emergency into consideration when surveying term ‘‘local’’ to this and parallel scenario, and a set of problem providers and suppliers on this training provisions throughout the rule to clarify statements, directed messages, or and testing requirement. that hospitals must develop and prepared questions designed to Response: We believe that this final maintain an emergency preparedness challenge an emergency plan. rule establishes core components of an communication plan that also complies We proposed at § 482.15(d)(2)(iv) that emergency preparedness program that with local laws. hospitals analyze their response to, and align to national emergency • Revising § 482.15(c)(4) by replacing maintain documentation on, all drills, preparedness standards and can be used the term ‘‘ensure’’ with ‘‘maintain.’’ tabletop exercises, and emergency not only for hospitals, but across • Revising § 482.15(c)(5) to clarify events, and revise the hospital’s provider and supplier types, while that hospitals must develop a means, in emergency plan as needed. tailoring requirements for individual the event of an evacuation, to release We received many comments on our provider and supplier types to their patient information, as permitted under proposed changes to require a hospital specific needs and circumstances, as 45 CFR 164.510(b)(1)(ii). to develop and maintain an emergency well as the needs of their patients,

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residents, clients, and participants. We ultimately improving communications effectiveness of the hospital’s proposed individual requirements for across the board in the event of an emergency plan and to use the results of each provider and supplier type that emergency. drills and exercises to improve the will be surveyed at the individual Response: We agree that first hospital’s plan. We would also expect facility level. As with the standard responders are an essential part of the that a hospital would want to provide surveying process, each provider and emergency management community and insightful and meaningful training, and supplier type will be individually are relied upon heavily during a man- would therefore tailor its training surveyed for their specific training and made or natural disaster. However, we materials to the audience receiving the testing requirements, rather than in do not have the statutory authority to instruction. A hospital may always comparison to the capabilities of other regulate first responders and emergency choose to establish internal facility healthcare settings affected by this management personnel. In an effort to policies that go beyond the minimum regulation. In addition, as discussed bolster communication and health and safety standards that we are earlier, we are finalizing our proposal collaboration, we proposed to require finalizing. for an implementation date that is one- that providers and suppliers include in Comment: A few commenters pointed year after the effective date of this final their emergency plan a process for out that many healthcare facilities are rule. This implementation date will ensuring cooperation and collaboration actively educating their staff on allow providers who may not be with local, tribal, regional, state, and emergencies specific to their experienced in emergency preparedness federal health department and environments and conducting planning, time to access resources and emergency preparedness officials’ preparedness exercises. Some develop plans that best meet their efforts. This would include commenters suggested that annual needs. We are not requiring that any documentation of efforts to contact such training would only be appropriate for facility have a designated staff member officials and, when applicable, their staff members who may take on responsible for emergency participation in collaborative and positions in an emergency, but would be preparedness. However the facility may cooperative planning efforts. We also irrelevant to a large portion of the choose to establish such a position. encourage providers and suppliers to system’s staff. Comment: A few commenters engage and collaborate with their local A few comments stated that our recommended that we specifically healthcare coalition, which commonly proposal for annual staff training is require that the training and testing includes the health department, inappropriate, redundant in many program be developed consistent with emergency management, first situations, and a waste of scarce the principles of the Homeland Security responders, and other emergency healthcare resources. Some commenters Exercise and Evaluation Program preparedness professionals. recommended that we only require (HSEEP). A commenter believed that Comment: A commenter suggested annual training and exercises for those our proposed requirement is not specific that the requirement for a training and providers that would be instrumental in enough and should lay out exactly what testing program specify that drills and a disaster and require less frequent our expectations are for a successful exercises must address varying training and exercises for those training program and what exactly is emergencies supporting the proposed providers that would not be expected to required. Another commenter pointed all-hazards approach to planning. The be operational during a disaster. out that, while we referenced the commenter explained that this would Response: As evidenced by every new principles of HSEEP in the preamble, include flooding in a portion of a disaster, and by the GAO and OIG we did not require such principles in building due to a water line rupture as reports that we discussed in the our regulations. A commenter suggested well as flooding that requires evacuation proposed rule (See 78 FR 79088), we that we require all healthcare facilities of patients. Another commenter believe that there is substantial evidence to receive training in an incident suggested that the training program that provider and supplier staff need command system. should be competency-based. The more training in emergency practices Response: We appreciate the commenter believed that competencies and procedures. Initial and annual staff recommendations. The requirements we help connect training and testing, in training promotes consistent staff establish are the minimum health and essence providing a common behavior and increases the knowledge of safety standards that facilities must denominator and language at the facility staff roles and responsibilities during a meet; however, a provider or supplier preparedness level. The commenters disaster. To offset some of the financial may choose to set higher standards for also stated that the disaster medicine impact that training may impose on its facility. In the proposed rule, we and public health community has long facilities, we have allowed facilities the provided facilities with resources and recognized the importance of flexibility to determine the level of examples to help them begin developing competencies, as evidenced by the training that any staff member may a training and testing program. We do multiple competency sets developed for need. A provider could decide to base not believe that we should limit the disaster health. this determination on the staff member’s principles/guidelines that a facility may Response: While not explicitly stated, involvement or expected role during a want to utilize when developing its we would assume that a hospital’s disaster. In addition, since staff program. training materials and testing exercises members may be expected to act outside Comment: A commenter supported would be reflective of the risk of their usual role during a disaster, our proposal for the development of an assessment that is required as part of providers could also decide to equally emergency preparedness training their emergency plan, utilizing an all- train staff on varying functions during a program, but suggested that hospitals hazards approach. In order to accurately disaster. In this final rule we have and all providers and suppliers include assess its plan, a hospital would need to revised our proposal to allow for large first responders in all aspects of their have training and exercises that address health systems to develop an integrated training program. The commenter stated realistic threats based on their risk emergency preparedness program for all that the inclusion of first responders assessment, otherwise the training and of their facilities, which would include would help to ensure consistency, testing program would not be effective. an integrated training program. allowing both groups to do their jobs in The purpose of the training and testing Therefore, to offset some of the financial a more productive and safer manner, program is to demonstrate the burden, facilities that are part of a large

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health system may opt to participate in demonstrate knowledge of their the hospital to identify which of these their health system’s universal training facility’s emergency procedures. We contracted individuals should receive program. However, the training at each believe that this requirement, in training. Furthermore, a commenter separately certified facility must address addition to the annual training posed a set of specific scenarios for us the individual needs for such facility requirement, requires facilities to ensure to consider, including whether the and maintain individual training that staff is continuously being updated employees of a contracted food service, records in order to demonstrate and educated on a facility’s emergency or a contracted plumber or electrician compliance. procedures and encourages facilities to would need to have emergency Comment: A few commenters ensure that the annual trainings are preparedness training before they are requested that we clarify what annual informative and insightful, so that staff able to work in the hospital. Similarly, training would involve and define the can demonstrate knowledge of the this commenter believed that the minimum requirements of training procedures. We would also expect that language, as proposed, needed to be needed to meet this annual training the results of the knowledge check clarified. requirement. should produce information that can be In addition, a commenter requested Response: We are giving facilities the used to update the emergency plan and that we further define what we mean by flexibility to determine the focus of their any future training. ‘‘volunteers’’ who would need to be annual training. Because we are Comment: Several commenters agreed trained. The commenter stated that the requiring that the emergency plan and that training of staff and volunteers is a term was vague and questioned whether policies and procedures be updated at significant aspect of emergency every volunteer would need training, least annually, staff would need to be planning and pointed out that, in a and if so, what level of training. The trained on any updates to the emergency disaster, many members of the hospital commenter also inquired about a plan and policies and procedures. For staff will continue to perform the same requested time frame for volunteers to instance, acceptable annual training job they do every day. Commenters complete training and how often could include training staff on new pointed out that most hospitals already volunteers would be required to be evacuation procedures that were provide basic awareness level training retrained. The commenter pointed out identified in the facility’s risk to staff as well as more comprehensive that volunteers are under no obligation assessment and added to the emergency training for employees who are assigned to report for duty and cannot be relied plan within the last year. a leadership or management role in the upon to perform specified Comment: A commenter did not hospital’s incident command system responsibilities during a disaster. support our proposed requirement for during an emergency. Finally, a commenter requested that annual training and stated that a Several commenters requested that we we include a definition of ‘‘staff’’ in our demonstration of skill requires some clarify who exactly we are referring to proposal to require staff training, since method of physical validation. The in paragraph § 482.15(d)(1)(i), which many inpatient hospital-based commenter also stated that annual states that individuals providing specialists, such as hospitalists or training would be overly burdensome services under arrangement must neonatologists, now provide much of for providers. Another commenter receive initial training in emergency the inpatient medical care. The suggested that instead of requiring preparedness policies and procedures. commenter also suggested that we annual training, we should require Several commenters requested that we require hospitals to identify individuals annual validation of knowledge through provide examples to eliminate any on staff and under contract that would written testing, demonstration, or real- confusion about the use of the phrase. need basic training, as well as staff that world response based on plans and Other commenters stated that they would likely manage an emergency policies. A commenter expressed believed that CMS was referring to event. The commenter suggested that we support for the intent of the annual groups of physicians, other clinicians, require hospitals to have a documented training requirement, but encouraged and others who provide services training plan for individuals with key CMS to provide more detail and essential for adequate care of patients responsibilities. The commenter also information related to specific levels of and maintenance of operation of the stated that hospitals should not be training for individual healthcare facilities, but whose relationship with required to train all staff, contractors, workers within a provider or supplier the hospital is by contract rather than and volunteers given that the costs organization. Also, some commenters through employment or voluntary associated with such training would far requested clarification on how staff status. The commenters pointed out that exceed the benefit in times of scarce would demonstrate their knowledge of there may be others with whom a resources. emergency preparedness. hospital would have an arrangement for Response: We appreciate all of the Response: We thank the commenters the provision of services, but these may detailed feedback that we received from for their feedback. We did not specify be services that would not be essential commenters on this requirement. The the content of a facility’s annual during the course of a disaster. For term ‘‘staff’’ refers to all individuals that training. The purpose of the example, the commenters explained that are employed directly by a facility. The requirement is to ensure that facilities hospitals often have arrangements for phrase ‘‘individuals providing services are continually educating their staff on servicing of office equipment, provision under arrangement’’ means services their emergency preparedness of staff training and education, grounds furnished under arrangement that are procedures and discussing how to keeping, and so forth. The commenters subject to a written contract conforming implement such procedures during an stated that they do not believe it was our with the requirements specified in emergency. We believe that it is up to intent for all personnel covered by these section 1861(w) of the Act. According to a provider or supplier to determine arrangements to be trained for our regulations, governing boards, or a what level of training is required of their emergency preparedness, but would legally responsible individual, ensures staff based on their individual appreciate some clarification. that a facility’s policies and procedures emergency plans and policies and Several commenters recommended are carried out in such a manner as to procedures. We note that we also that we allow hospitals the flexibility to comply with applicable federal, state proposed to require at § 482.15(d)(1)(iv) identify outsourced services that would and local laws. We believe that anyone, that hospitals ensure that staff can be essential during a disaster and allow including volunteers, providing services

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in a facility should be at least annually ‘‘community’’, to afford providers the industry terms evolve and change, so trained on the facility’s emergency flexibility to develop disaster drills and there is a need to ensure that the terms preparedness procedures. As past exercises that are realistic and reflect in our regulations are broad and disasters have shown, emergency their risk assessments. However, the inclusive, with a ‘‘plain language’’ situations or disasters can be either term could mean entities within a state meaning to the extent possible. In this expected or unexpected. Therefore, or multi-state region. The goal of the final rule, we are revising our proposal training should be made available to provision is to ensure that healthcare by replacing the term ‘‘community mock everyone associated with the facility, providers collaborate with other entities disaster drill’’ with ‘‘full-scale exercise.’’ and it is up to the facility to determine within a given community to promote We believe that this term is broad the level to which any specific an integrated response. In the proposed enough to encompass the suggested individual should be trained. One way rule, we indicated that we expected terms from commenters, as well as an this could be determined is by that hospitals and other providers to accurate description of the intent individual’s involvement or expected participate in healthcare coalitions in behind the provision. role during an emergency. We stated at their area for additional assistance in Comment: A few commenters § 482.15(d)(1)(i) that training should be effectively meeting this requirement. requested further clarification as to provided consistent with facility staff’s Conducting exercises at the healthcare when a facility-based disaster drill expected roles. To mitigate costs it may coalition level could help to reduce the could replace a community disaster be beneficial for facilities to take this administrative burden on individual drill. Most of the commenters pointed approach when establishing their healthcare facilities and demonstrate the out that smaller hospitals and those training programs. In addition, as we value of connecting into the broader providers outside of the hospital may state elsewhere in this preamble, we medical response community, as well as not have close ties to emergency encourage facilities to participate in the local health and emergency responders or community agencies that healthcare coalitions in their area. management agencies, during organize drills. Another commenter Depending on their duties during an emergency preparedness planning and wanted to know what requirements emergency, a facility may determine response activities. Conducting would be placed on state and local that documented external training is integrated planning with state and local governments to include all provider sufficient to meet the facility’s entities could identify potential gaps in types in their disaster drill planning. requirements. state and local capabilities that can then Response: We would expect that a Comment: Many commenters be addressed in advance of an facility-based disaster drill would meet supported the requirement for emergency. Regional planning coalitions the requirement for a community participation in a community drill/ (multi-state coalitions) meet and carry disaster drill if a community disaster exercise and stated that it would better out exercises on a regular basis to test drill were not readily accessible. For prepare both facility staff and patients protocols for state-to-state mutual aid. example, a rural provider located in a regarding procedures in an actual The members of the coalitions are often remote location might have limited emergency. However, a few commenters able to test incident command and ability to participate in a community requested clarification of the control procedures and processes for disaster drill and would conduct a requirement. Specifically, some sharing of assets that promote medical facility-based drill in order to comply commenters requested that we clarify surge capacity. with this requirement. The intention of what we meant by ‘‘community,’’ while Comment: Several commenters this requirement is to not only assess another commenter encouraged CMS to indicated that the term ‘‘mock’’ disaster the feasibility of a provider’s emergency allow organizations to define their drill is not a common term in plan through testing, but also to community as they saw fit rather than emergency exercise vocabulary. Some encourage providers to become engaged based on geographical locations. A recommended that we use the in their community and promote a more commenter questioned if standard state- Homeland Security Exercise and coordinated response. Therefore, required emergency drills would meet Evaluation Program vocabulary, smaller facilities without close ties to the requirement of a community disaster ‘‘disaster drill exercise.’’ Another emergency responders and community drill. The commenter noted that in their commenter suggested that we use the agencies are encouraged to reach out state, all facilities are required to preferred term of ‘‘functional’’ or ‘‘full- and gain awareness of the emergency participate in a statewide tornado drill scale exercise.’’ Commenters believed resources within their community. We that evaluates the facility and staff on that these terms are clearer in regard to note that CMS does not regulate state their ability to recognize the threat alert the expectations for hospitals and other and local governments’ disaster and respond to the alert in accordance providers. planning activities. with their emergency plan. Another Response: We appreciate the Comment: Most commenters commenter requested that we specify suggestions and agree that the term supported our proposal to exempt how intensive an exercise would need could be revised to more appropriately providers from the community mock to be in order to meet the new reflect the intention of the requirement. drill requirement if the facility had requirements. In contrast to an instructor led tabletop experienced a disaster in the past year. Response: We understand that many exercise utilizing discussion, the A few commenters requested disasters, such as floods, can involve a requirement for participation in a clarification on what would be wide geographic area. In addition, we community disaster drill exercise is considered activation of a facility’s plan. also recognize that many hospitals and meant to require facilities to simulate an The commenter wondered if there various providers operate as part of a anticipated response to an emergency would have to be involvement of local large health system. However, we would involving their actual operations and emergency management or whether the still expect a hospital or other the community. We are aware that there activation could be made by the facility healthcare facility to consider its are several current terms used to itself. physical location and the individuals describe types of exercises and Response: In the proposed rule we who reside in their area when understand how the use of the term stated that for the purpose of the conducting their community involved ‘‘mock disaster drill’’ may leave room proposed regulation, ‘‘emergency’’ or testing exercises. We did not define for confusion. However, we note that ‘‘disaster’’ can be defined as an event

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affecting the overall target population or decision should be left to the discretion for a tabletop exercise is impractical for the community at large that precipitates of the facility. smaller providers and suggested that we the declaration of a state of emergency Comment: A commenter suggested base the necessity of the requirement on at a local, state, regional, or national that we require the tabletop exercises to facility size. level by an authorized public official focus on decompression of existing Many commenters stated that most such as a governor, the Secretary of staffed beds (that is, how to move less accrediting organizations and HHS, or the President of the United critically ill patients out of the facility), emergency response organizations States (see 78 FR 79084). In addition, as identification of alternate space within require that providers test their noted earlier in the general comments a facility or adjacent campus buildings, emergency plans at least twice annually section of this final rule, an emergency and sheltering in place. The commenter through fully operational exercises; event could also be an event that affects also pointed out that many accrediting these organizations do not accept a the facility internally as well as the organizations require medical surge tabletop exercise to satisfy this overall target population or the exercises, which could be combined in requirement. These commenters community at large. While allowing for a decompression/surge scenario to recommended that we require two the exemption of the community incorporate issues that could occur in a disaster drills annually and eliminate disaster drill requirement when an real life event and might be a better the requirement for a tabletop exercise. actual emergency event is experienced, focus for facility exercises. Furthermore, the commenters we also proposed to require that Response: We appreciate the recommended that one of the drills be facilities maintain documentation of all commenter’s suggestion. We understand a community drill. Commenters also exercises and emergency events. To that that depending on varying factors, such suggested that we exempt those extent, upon survey, a facility would as provider type, size of facility, facilities that participate in two annual need to show that an emergency event complexity of offered services, and disaster drills from the tabletop exercise location, facilities will have differing had occurred and be able to demonstrate requirement. A commenter suggested risks and needs. Therefore, we believe how its emergency plan was put into that we require a community mock that facilities should have the flexibility action as a result of the emergency disaster drill 1 year and a tabletop to determine the focus of their exercises event. exercise the next year, rather than both based upon their individual risk Comment: Many commenters in the same year. A commenter stated assessment, emergency plan, and requested clarification of our proposal that conducting a disaster drill would policies and procedures. We note that, to require one tabletop exercise require a good amount of planning and annually. Commenters stated that we without more information about the interruption of clinical services, did not provide a clear expectation of specific medical surge exercise, in order therefore reducing this requirement to what tabletop exercise would meet our to assess compliance, facilities would every other year would reduce the requirements. Commenters also need to be able to demonstrate to burden on the facility. Another recommended that we note that tabletop surveyors how the medical surge commenter requested that we allow exercises could be computer-simulated exercise appropriately tests the facility’s providers the flexibility to determine and that we should not limit the emergency preparedness plan. the type of drill or exercise needed to requirement to paper-based tabletop Comment: Multiple commenters test their plan in accordance with their exercises. A commenter noted that we expressed their concern regarding our internal policies and procedures. were silent regarding who could serve intent to require both a community as a facilitator for the tabletop exercise mock disaster drill and a tabletop Response: We continue to believe that and questioned if a facilitator could be exercise every year and questioned the both a disaster drill and a tabletop a staff member. need for both. We received conflicting exercise are effective in emergency Response: In the proposed rule, we comments about the accessibility and preparedness planning. We understand indicated that we would define a burden of participating in a community that while beneficial, drills and tabletop exercise as a group discussion mock disaster drill. While a few exercises have financial implications led by a facilitator, using a narrated, commenters stated that a community that can be burdensome for some clinically-relevant emergency scenario, mock drill would be burdensome and provider and supplier types. Many and a set of problem statements, require significant planning and time, commenters observed that most directed messages, or prepared other commenters stated that most hospitals are currently conducting drills questions designed to challenge an organizations have several opportunities and exercises, so any additional emergency plan. We believe that this to participate in some type of integrated financial impact would be minimal. would also include the use of computer- preparedness training exercise within Therefore, in this final rule we are simulated exercises. We also suggested their community every year. We also revising our proposed provision at that providers and suppliers consider received conflicting comments about the § 482.15(d)(2) to require facilities to using, among other resources, the effectiveness of tabletop exercises. A conduct one full-scale exercise and an tabletop exercise toolkit developed by few commenters stated that tabletop additional exercise of their choice, the New York City Department of Health exercises do not adequately determine which could be a second full-scale and Mental Hygiene’s Bureau of the functionality of an emergency plan exercise or a tabletop exercise. We note Communicable Diseases (September and can reduce a facility’s level of that the full-scale exercise must be 2005, found at: http://www.nyc.gov/ preparedness. Another commenter community-based unless a community html/doh/downloads/pdf/bhpp/bhpp- stated that tabletop exercises are an exercise is not available. Facilities may train-hospital-toolkit-01.pdf or the efficient way to test policies that are opt to conduct more exercises, as RAND Corporation’s 2006 tabletop currently in the plan and ensure that needed, to improve their emergency exercise technical report (http:// staff is knowledgeable about current plans and prepare their staff and www.rand.org/pubs/technical_reports/ operating procedures. Another patients and are encouraged to include 2006/RAND_TR319.pdf) to help them commenter stated that tabletop exercises community-based partners in all of their comply with this requirement. We were add value, but that a full-scale disaster additional exercises where appropriate. purposely silent on who could facilitate drill is considered a best practice. A We believe that this revision will give a tabletop exercise and believe that commenter stated that the requirement facilities the ability to determine which

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exercise is most beneficial to them as thorough completion of the template • Revising § 482.15(d)(2) to allow a they consider their specific needs. would comply with our requirements hospital to choose the type of exercise Comment: A commenter suggested for provider exercise documentation. it will conduct to meet the second that CMS require providers of all types Lastly, we believe our proposed annual testing requirement. to participate at least once annually in requirement at § 482.15(d)(2)(i) and (iii) instructional programs, presentations, or 5. Emergency Fuel and Generator that a disaster drill and a tabletop Testing (§ 482.15(e)) discussion forums delivered by state exercise be conducted annually health departments. addresses the commenter’s concern We proposed at § 482.15(e)(1)(i) that Response: We do not believe that it is about subsequent exercises and retesting hospitals store emergency fuel and appropriate to compel providers to since a facility can test any problems it associated equipment and systems as attend instructional programs, identifies in an upcoming testing required by the 2000 edition of the Life presentations, or discussion forums Safety Code (LSC) (NFPA®101) of the exercise. ® delivered by state health agencies. Comment: We received a few NFPA . We note that CMS recently However, as noted in § 482.15, hospitals comments on our proposed requirement issued a final rule on May 4, 2016 must comply with all applicable federal for hospitals to analyze the hospital’s entitled ‘‘Medicare and Medicaid and state emergency preparedness response to, and maintain Programs; Fire Safety Requirements for requirements. Therefore, if a hospital is Certain Health Care Facilities’’ (81 FR documentation for, all drills, tabletop ® located in a state that mandates that exercises, and emergency events, and 26872), to adopt the NFPA 2012 hospitals participate in emergency revise the hospital’s emergency plan, as edition of the LSC and the ‘‘Health Care preparedness instructional programs, needed. A commenter questioned how Facilities Code.’’ The current LSC states the hospital must comply with that long after a training the documentation that a hospital’s alternate source of state’s laws. In addition, if hospitals’ of such training would need to be power (for example, a generator), and all management determines such programs retained. Another commenter connected distribution systems and to be beneficial to such hospitals in recommended that, if a hospital were to ancillary equipment, must be designed development or maintenance of their experience two or more actual to ensure continuity of electrical power to designated areas and functions of a emergency preparedness plans, such emergencies and performs an after- healthcare facility. Also, the LSC states hospitals have the discretion, under action review of its emergency plan, it that the rooms, shelters, or separate these requirements, to attend such should be exempt from this programs as they see fit, or they can buildings housing the emergency power requirement. incorporate such requirements into their supply must be located to minimize the Response: We believe that this training programs. It is not a possible damage resulting from disasters requirement is necessary to ensure that requirement of these CoPs that hospitals such as storms, floods, earthquakes, hospitals are benefiting from the lessons attend programs overseen by state tornadoes, hurricanes, vandalism, learned through testing their plans and health departments. sabotage and other material and Comment: A commenter suggested revising them as necessary, based on equipment failures. that we require completion of after- these lessons. We believe that, if a In addition to the emergency power action reports (AARs) and Improvement hospital experiences an actual system inspection and testing Plans (IP) following the completion of emergency and develops an after-action requirements found in NFPA® 99, drills, exercises, and real events. The review, it would be practical for the ‘‘Health Care Facilities Code,’’ NFPA® commenter also suggested that these hospital to use this as an opportunity to 101,‘‘Life Safety Code,’’ and NFPA® documents be made available for revise and update their plan 110, ‘‘Standard for Emergency and surveyors. In addition, the commenter accordingly. In addition, we would Standby Power Systems,’’ we proposed indicated that subsequent exercises and expect a facility to maintain training that hospitals test their emergency and retesting should also be required to documentation to demonstrate that it stand-by-power systems for a minimum demonstrate that improvements were has met the training requirements. We of 4 continuous hours every 12 months successfully made. note that hospitals are required at at 100 percent of the power load the Response: We proposed to require at § 482.15(d) to update and review their hospital anticipates it will require § 482.15(d)(2)(iv) that hospitals analyze training and testing program at least during an emergency. their response to, and maintain annually. We also proposed emergency and documentation of, all drills, tabletop In summary, after consideration of the standby power requirements for CAHs exercises, and emergency events, and public comments, we are finalizing our and LTC facilities. As such, we revise the hospital’s emergency plan, as proposal for hospitals to develop and requested information on this proposal, needed. Demonstrating the thorough maintain an emergency preparedness in particular on how we might better completion of an AAR or IP would meet training and testing program as estimate costs in light of the existing this requirement; however, we are not proposed, with the following LSC requirements, as well as other state requiring completion of specific reports, exceptions: and federal requirements. in order to give facilities some flexibility • Revising § 482.15(d) by adding that Comment: We received a large in this area. In addition, as an example, each hospital’s training and testing number of comments from individual we provided a link to the CMS program must be based on the hospital’s hospitals as well as national and state developed Health Care Provider AAR/IP emergency plan, risk assessment, organizations that expressed concern template in the proposed rule, which is policies and procedures, and with the proposed requirement for a voluntary and user-friendly tool for communication plan. hospitals, CAHs and LTC facilities to healthcare providers to use to document • Revising § 482.15(d)(1)(iv) by test their generators. The commenters their performance during emergency replacing the phrase ‘‘Ensure that staff recommended that we continue to refer planning exercises and real emergency can demonstrate’’ with the phrase to the current NFPA® standards for events, to inform recommendations for ‘‘Demonstrate staff knowledge.’’ generator testing, along with improvements for future performance. • Revising § 482.15(d)(2) by replacing manufacturers’ recommendations. Many We indicated that, while we do not the term ‘‘community mock disaster commenters stated that there was not mandate the use of this template, drill’’ with ‘‘full-scale exercise.’’ enough empirical data to support the

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proposed additional testing anticipated by increasing the frequency were provided, commenters claimed requirements. They further stated that of generator testing. that relocation of existing equipment there is no evidence that additional We also appreciate the commenters and systems would be cost-prohibitive. annual testing would result in more that pointed out the logistical and Response: We appreciate the support reliable generators. A commenter stated budgetary challenges for the healthcare of the commenters that agreed with the that a survey of hospitals affected by facilities that would be affected by this proposed requirement that generators be Hurricane Sandy did not indicate that rule. After carefully considering all of located in accordance with the the comments we received and requirements found in NFPA® 99, increased testing would prevent ® ® generator failure during an actual reviewing reports on Hurricane Sandy NFPA 101, and NFPA 110. These disaster (Flannery, Johnathan, ASHE and Hurricane Katrina (Live Science, codes require hospitals that build new Advocacy Report 2013, pages 34–37) ‘‘Why power is So Tricky for Hospital structures, renovate existing structures, (‘‘ASHE Report’’). Other commenters During Hurricanes’’, Rachael Rettner, or install new generators to place stated that hospitals already test November 1, 2012 see http://www.live backup generators in a location that science.com/24489-hospital-power- would be free from possible flooding generators monthly as well as a 4 hour outages-hurricane-sandy.html), we and destruction. As such, the CMS test every 3 years and, in their opinion, believe that there are not sufficient data requirements are aligned with the Life this testing schedule is sufficient. Some to assume that additional testing would Safety Code (NFPA® 101), (which has commenters stated that mandating ensure that generators would withstand been generally incorporated into CMS additional testing would further burden all disasters, regardless of the amount of regulations) which cross-references already strained budgets because many testing conducted prior to an actual 2012 NFPA® 99 and NFPA® 110, at healthcare facilities have more than one disaster. Therefore, we have decided § 482.15. generator. They stated that the against finalizing the proposed Comment: A few commenters additional testing would cause requirement for additional generator recommended that CMS consider unnecessary wear and tear on the testing at this time. We would expect bringing any additional generator equipment. Also, complying with the facilities that have generators to requirement to the NFPA® Technical requirement for additional testing in continue to test their equipment based Committees that maintain standards for certain geographical locations, such as on NFPA® codes in current general use emergency and stand-by power. California, could increase air pollution (2012 NFPA® 99, 2010 NFPA® 110 and Response: The NFPA® is a private, and the potential for some facilities to 2012 NFPA® 101) and manufacturer nonprofit organization dedicated to be fined by the EPA for emitting requirements. Accordingly, we have reducing loss of life due to fire and additional carcinogens in the air. revised § 482.15(e)(1) and (2) by other disasters. We have incorporated Another commenter raised concerns removing the additional testing some of NFPA’s codes, by reference, in that this increase in operational time requirements and adding a new our regulations. The statutory basis for may require additional guidance or paragraph (h) which incorporates by incorporating NFPA’s Codes for our permit validation from the reference the 2012 version the NFPA® providers and suppliers is the Environmental Protection Agency (EPA) 99, 2010 NFPA® 110 and 2012 NFPA® Secretary’s general authority to stipulate due to the increase in emissions. 101. As discussed in this final rule, we such additional regulations for each type of Medicare and Medicaid Response: We appreciate the are also removing the additional participating facility as may be commenters concerns on this issue. As generator testing requirements for CAHs necessary to protect the health and we discussed in the proposed rule, the and LTC facilities. Comment: Several commenters stated safety of patients. In addition, CMS has purpose of the proposed change in the that CMS standards regarding the discretionary authority to develop and testing requirement was to minimize the location and maintenance of generators set forth health and safety regulations issue of inoperative equipment in the should be aligned as much as possible that govern providers and suppliers that event of a major disaster, as occurred with existing standards, laws and participate in the Medicare and with Hurricane Sandy. The September regulations, to avoid conflict and Medicaid programs. 2014 report of the Office of Inspector confusion; and that the standards Comment: A few commenters stated General (OIG) entitled, ‘‘Hospital should be evaluated and updated that facilities should be required to have Emergency Preparedness and Response periodically to reflect new knowledge a backup plan that addresses the loss of During Hurricane Sandy’’ (OIG, OEI– and advances in technology. Many power in a way that would allow them 06–13–00260, September 2014) stated commenters agree with the proposed to continue operations without outside that 89 percent of hospitals reported rule that would require a hospital’s electricity. The commenter stated that experiencing critical challenges during generator to be located in accordance this could be addressed a number of Sandy, ‘‘such as electrical and with the requirements found in NFPA® ways, including by diverting patients to communication failures, to community 99, NFPA® 101, and NFPA® 110. a nearby facility within a reasonable collaboration issues over resources, Furthermore, they commented that CMS commuting distance that has sufficient such as fuel, transportation, hospital should be aligned with NFPA® in how power for the facility to treat patients. beds, and public shelters.’’ According to it implements these standards. They Response: We agree with the a survey conducted by The American stated that requirements already exist commenters. We would encourage Society for Healthcare Engineering through NFPA® and local building facilities to develop an emergency plan (ASHE) of its member facilities affected codes, and that facilities currently that explores the best case scenarios to by Hurricane Sandy (ASHE Report comply with all applicable ensure optimum protection for patients pages 34–37), 35 percent of the survey requirements. They also stated that the and residents during an emergency. respondents reported that they were requirement for all emergency There are times when we would expect without power for a period of time that generators to be located in an area that a facility to shelter in place and other ranged from 30 minutes to over 150 is free from possible flooding should times when it might be more feasible to hours. However, ASHE’s survey only apply to new installations, evacuate. However, a hospital, or other concluded that there is no indication construction or renovation of existing inpatient provider, is likely to have that equipment failure could have been structures. While no empirical data inpatients at the beginning of a disaster,

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even when evacuation is planned. • Revising § 482.15(e)(2)(i) by The existing ‘‘Physical environment’’ Therefore, the facility must be able to removing the requirement for an CoP at § 403.742(a)(1) currently requires provide continued operations until all additional 4 hours of generator testing that the RNHCI provide emergency its patients have been evacuated and its and clarifying that facilities must meet power for emergency lights, for fire operations cease. the requirements of NFPA® 99 2012 detection and alarm systems, and for Comment: A few commenters stated edition, NFPA® 101 2012 edition, and fire extinguishing systems. Existing that alternate sources of energy to meet NFPA® 110 2010 edition. § 403.742(a)(4) requires that the RNHCI all regulatory requirements are currently • Revising § 482.15(e)(3) by removing have a written disaster plan that available through emergency generators. the requirement that hospitals maintain addresses loss of water, sewage, power They stated that it is neither practical fuel onsite and clarifying that hospitals and other emergencies. Existing nor prudent to require an emergency must have a plan to maintain operations § 403.742(a)(5) requires that a RNHCI generator at all healthcare facilities, unless the hospital evacuates. have facilities for emergency gas and • some of which simply close or relocate Adding a new § 482.15(h) to water supply. We proposed relocating during a power loss. incorporate by reference the the pertinent portions of the existing requirements of NFPA® 99, NFPA® 101, Response: We proposed that the ® requirements at § 403.742(a)(1), (4), and requirements for an emergency and NFPA 110. (5) at proposed § 403.748(a) and (b)(1). generator and onsite fuel source to D. Emergency Preparedness Regulations Proposed § 403.748(a)(1) would power the emergency generator would for Religious Nonmedical Health Care require RNHCIs to consider loss of apply only to hospitals, CAHs and LTC Institutions (RNHCIs) (§ 403.748) power, water, sewage and waste disposal in their risk analysis. The facilities. We did not include other Section 1861(ss)(1) of the Act defines proposed policies and procedures at providers/suppliers discussed in the the term ‘‘Religious Nonmedical Health § 403.748(b)(1) would require that proposed rule. Care Institution’’ (RNHCI) and lists the RNHCIs provide for subsistence needs Comment: Several commenters requirements that a RNHCI must meet to of staff and patients, whether they opposed requiring facilities that be eligible for Medicare participation. maintain an onsite fuel supply to We have implemented these evacuate or shelter in place, including, maintain a quantity of fuel capable of provisions in 42 CFR part 403, subpart but not limited to, food, water, sewage sustaining emergency power for the G, ‘‘Religious Nonmedical Health Care and waste disposal, non-medical duration of the emergency or until likely Institutions Benefits, Conditions of supplies, alternate sources of energy for resupply. The commenter pointed out Participation, and Payment.’’ As of June the provision of electrical power, the that this approach does not consider the 2016, there were 18 Medicare-certified maintenance of temperatures to protect situation in which a hospital or LTC RNHCIs that were subject to the RNHCI patient health and safety and for the safe facility would evacuate or close during regulations. and sanitary storage of such provisions, a prolonged emergency. A few A RNHCI is a facility that is operated gas, emergency lights, and fire commenters questioned how long a under all applicable federal, state, and detection, extinguishing, and alarm hospital should provide or maintain local laws and regulations, which systems. alternate sources of energy. Another provides only non-medical items and The proposed hospital requirement at commenter stated that what a facility services on a 24-hour basis to § 482.15(a)(1) would be modified for anticipates it will need during ‘‘an beneficiaries who choose to rely solely RNHCIs. We proposed at § 403.748(a)(1) emergency’’ does not necessarily match upon a religious method of healing and to require RNHCIs to consider loss of its in-house generator’s capacity. A for whom the acceptance of medical power, water, sewage and waste facility gap analysis would define services would be inconsistent with disposal in their risk analysis. At anticipated need per planned for their religious beliefs. The religious § 403.748(b)(1)(i) for RNHCIs, we emergency, and a facility’s in-house unit non-medical care or religious method of proposed to remove the terms ‘‘medical may be ample for some scenarios and healing means care provided under and nonmedical’’ to reflect typical not for others. A gap analysis may established religious tenets that prohibit RNHCI practice, since RNHCIs do not identify times when evacuation is conventional or unconventional medical provide most medical supplies. At recommended versus other scenarios care for the treatment of the patient and § 482.15(b)(3), we proposed that when in-house capacity is ample to exclusive reliance on religious activity hospitals have policies and procedures sustain operations. to fulfill a patient’s total healthcare for the safe evacuation from the Response: We appreciate all of the needs. hospital, which would include comments on this proposal. We realize The RNHCI does not furnish medical consideration of care and treatment that it would be difficult, if not items and services (including any needs of evacuees; staff responsibilities; impractical in certain circumstances, for medical screening, examination, transportation; identification of a facility to have a fuel supply that diagnosis, prognosis, treatment, or the evacuation location(s); and primary and would be sufficient for the duration of administration of drugs or biologicals) alternate means of communication with all disasters because the magnitude of to its patients. RNHCIs must not be external sources of assistance. At the disaster might require facilities to owned by, or under common ownership § 403.748(b)(3), we proposed to evacuate patients/residents. After a or affiliated with, a provider of medical incorporate this hospital requirement careful evaluation of the comments, we treatment or services. for RNHCIs but to remove the words have changed the final rule to require a We proposed to expand the current ‘‘and treatment’’ to more accurately hospital, CAH, or LTC facility to have a emergency preparedness requirements reflect that medical care is not provided plan for how it will keep emergency for RNHCIs, which are located within in a RNHCI. power systems operational during the § 403.742, Condition of participation: We proposed at § 403.748(b)(5) to emergency, unless it evacuates. Physical Environment, by requiring remove the term ‘‘health’’ from the After consideration of the comments RNHCIs to meet the same proposed proposed hospital requirement for we received on the proposed rule, we emergency preparedness requirements ‘‘health care documentation’’ to reflect are finalizing our proposal with the as we proposed for hospitals, subject to the non-medical care provided by following modifications: several exceptions. RNHCIs.

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The proposed hospital requirements required only to conduct a tabletop • Revising § 403.748(a)(4) by deleting at § 482.15(b)(6) would require hospitals exercise annually. Likewise, unlike our the term ‘‘ensuring’’ and replacing the to have policies and procedures to proposal for hospitals at term ‘‘ensure’’ with ‘‘maintain.’’ address the use of volunteers in an § 482.15(d)(2)(i), we did not propose • Revising § 403.748(b)(2) to remove emergency or other staffing strategies, that the RNHCI conduct a community the requirement for RNHCIs to track including the process and role for mock disaster drill at least annually or staff and patients after an emergency integration of state or federally conduct an individual, facility-based and clarifying that in the event that staff designated healthcare professionals to mock disaster drill. Although we and patients are relocated during an address surge needs during an proposed for hospitals at emergency, the RNHCI must document emergency. For RNHCIs, we proposed at § 482.15(d)(2)(ii) that, if the hospital the specific name and location of the § 403.748(b)(6) to use the hospital experiences an actual natural or man- receiving facility or other location for provision, but remove the language, made emergency, the hospital would be sheltered patients and on-duty staff who ‘‘including the process and role for exempt from engaging in a community leave the facility during an emergency. integration of state or federally or individual, facility-based mock • Revising § 403.748(b)(5)(iii) and designated healthcare professionals’’ disaster drill for 1 year following the (b)(7) to remove the term ‘‘ensure.’’ • since it is not within the religious onset of the actual event, we did not Revising § 403.748(c) by adding the framework of RNHCIs to integrate care propose this for RNHCIs. term ‘‘local’’ to clarify that the RNHCI issues for their patients with healthcare At § 482.15(d)(2)(iv), we proposed to must develop and maintain an professionals outside of the RNHCI require hospitals to maintain emergency preparedness industry. documentation of all drills, tabletop communication plan that also complies The proposed hospital requirements with local laws. exercises, and emergency events, and • at § 482.15(b)(7) would require that revise the hospital’s emergency plan, as Revising § 403.748(c)(5) to clarify hospitals develop arrangements with needed. Again, at § 403.748(d)(2)(ii), for that RNHCIs must develop a means, in other hospitals and other providers to RNHCIs, we proposed to remove the event of an evacuation, to release receive patients in the event of reference to drills. patient information, as permitted under limitations or cessation of operations to Currently, at § 403.724(a), we require 45 CFR 164.510(b)(1)(ii). • Revising § 403.748(d) by adding ensure the continuity of services to that an election be made by the that each RNHCI’s training and testing hospital patients. For RNHCIs, at Medicare beneficiary or his or her legal program must be based on the RNHCI’s § 403.748(b)(7), we added the term representative and that the election be ‘‘non-medical’’ to accommodate the emergency plan, risk assessment, documented in a written statement that uniqueness of the RNHCI non-medical policies and procedures, and the beneficiary: (1) Is conscientiously care. communication plan. The proposed hospital requirement at opposed to accepting non-excepted • Revising § 403.748(d)(1)(iv) by § 482.15(c)(1) would require hospitals to medical treatment; (2) believes that non- replacing the phrase ‘‘ensure that staff include in their communication plan: excepted medical treatment is can demonstrate’’ with the phrase Names and contact information for staff, inconsistent with his or her sincere ‘‘demonstrate staff.’’ entities providing services under religious beliefs; (3) understands that E. Emergency Preparedness Regulations agreement, patients’ physicians, other acceptance of non-excepted medical for Ambulatory Surgical Centers (ASCs) hospitals, and volunteers. For RNHCIs, treatment constitutes revocation of the (§ 416.54) we proposed substituting ‘‘next of kin, election and possible limitation of guardian or custodian’’ for ‘‘patients’ receipt of further services in a RNHCI; Section 1833(i)(1)(A) of the Act physicians’’ because RNHCI patients do (4) knows that he or she may revoke the authorizes the Secretary to specify those not have physicians. election by submitting a written surgical procedures that can be Finally, unlike the proposed statement to CMS, and (5) knows that performed safely in an ASC. The regulations for hospitals at the election will not prevent or delay surgical services performed in ASCs are § 482.15(c)(4), we proposed at access to medical services available scheduled, elective, procedures for non- § 403.748(c)(4), we propose to require under Medicare Part A in facilities other life-threatening conditions that can be RNHCIs to have a method for sharing than RNHCIs. Thus, at § 403.748(c)(4), safely performed in a Medicare-certified information and care documentation for we proposed that such election ASC setting. patients under the RNHCIs’ care, as documentation be shared with other Section 416.2 defines an ambulatory necessary, with healthcare providers to care providers to preserve continuity of surgical center (ASC) as any distinct ensure continuity of care, based on the care during a disaster or emergency. entity that operates exclusively for the written election statement made by the We did not receive any comments that purpose of providing surgical services to patient or his or her legal representative. specifically addressed the proposed rule patients not requiring hospitalization, Also, at proposed § 403.748(c)(4), we as it related to RNHCIs. However, after and in which the expected duration of removed the term ‘‘other’’ and ‘‘health’’ consideration of the general comments services would not exceed 24 hours from the requirement for sharing we received on the proposed rule, as following an admission. information with ‘‘other health care discussed in the hospital section As of June 2016 there were 5,485 providers’’ to more accurately reflect the (section II.C. of this final rule), we are Medicare certified ASCs in the U.S. The care provided by RNHCIs. finalizing the proposed emergency ASC Conditions for Coverage (CfCs) at At § 482.15(d)(2), ‘‘Testing,’’ we preparedness requirements for RNHCIs 42 CFR part 416, subpart C, are the proposed that hospitals would be with the following modifications in health and safety standards a facility required to conduct drills and exercises response to general comments made must meet to obtain Medicare to test their emergency plan. Because with respect to all facilities: certification. Existing § 416.41(c) RNHCIs have such a narrow role and • Revising the introductory text of requires ASCs to have a disaster provide such a unique service in the § 403.748 by adding the term ‘‘local’’ to preparedness plan. This existing community, we believe RNHCIs would clarify that RNHCIs must also comply requirement states the ASC must: (1) not participate in performing such with local emergency preparedness Have a written disaster plan that drills. We proposed that RNHCIs be requirements. provides for the emergency care of its

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patients, staff and others in the facility; However, we disagree with the during a disaster or emergency (2) coordinate the plan with state and commenter’s statement that emergency situation. We expect that ASCs will local authorities; and (3) conduct drills preparedness requirements for ASCs are document their efforts to contact at least annually, complete a written burdensome and inflexible. We pertinent emergency preparedness evaluation of each drill, and promptly continue to believe that ASCs should officials and, when applicable, implement any correction to the plan. develop an emergency preparedness document their participation in any Since the proposed requirements are plan that is based on a facility-based collaborative and cooperative planning similar to and would be redundant with and community-based risk assessment efforts. We understand that providers existing rules, we proposed to remove utilizing an all-hazards approach. We cannot control the actions of other existing § 416.41(c). Existing believe that the emergency preparedness entities within their community and we § 416.41(c)(1) would be incorporated requirements finalized in this rule are not expecting providers to hold into proposed § 416.54(a), (a)(1), (2), and provide ASCs and other providers with others accountable for their (4). Existing § 416.41(c)(2) would be the flexibility to develop a plan that is participation or lack of participation in incorporated into proposed tailored to the specific needs of an community emergency preparedness § 416.54(a)(4) and (c)(2). Existing individual ASC. There are several key efforts. However, providers do have § 416.41(c)(3) would be incorporated differences between the requirements control over their own efforts and can into proposed § 416.54(d)(2)(i) and (iv). for ASCs and hospitals, including but develop a plan to cooperate and We proposed to require ASCs to meet not limited to subsistence needs collaborate with members of the most of the same proposed emergency requirements and the requirements to emergency preparedness community. preparedness requirements as those we implement an emergency and standby We continue to believe that proposed for hospitals, with two power system. We have taken into communication and cooperation with exceptions. At § 416.54(c)(7), we consideration the unique characteristics pertinent emergency preparedness proposed that ASCs be required to have of an ASC and have finalized flexible officials is an important part of a policies and procedures that include a and appropriate emergency coordinated and timely response to an means of providing information about preparedness requirements for ASCs. emergency. the ASCs’ needs and their ability to Comment: Several commenters agreed Comment: Several commenters provide assistance (such as physical with exempting ASCs from the expressed concern about the proposal to space and medical supplies) to the requirements to provide occupancy require that ASCs develop arrangements authority having jurisdiction (local, information and subsistence needs for with other ASCs and other providers to state agencies) or the Incident Command staff and patients. The commenters receive patients in the event of Center, or designee. However, we did noted that these requirements would be limitations or cessation of operations to not propose that these facilities provide inappropriate for the ASC setting since ensure the continuity of services to ASC information regarding their occupancy, many patients may visit an ASC once or patients. The commenters noted that as we proposed for hospitals, since the twice during an episode of care. many ASCs offer specific, specialized term ‘‘occupancy’’ usually refers to However, the commenters noted that elective procedures and non-emergency occupancy in an inpatient facility. other emergency preparedness services and that the staff that work in Additionally, we did not propose that requirements are inappropriate for the an ASC do not have experience with these facilities provide for subsistence ASC setting. The commenters expressed trauma surgery and triaging. They also needs of their patients and staff. concern about the requirement that noted that, in case of an emergency, Comment: Many commenters ASCs must develop an emergency ASCs would cancel upcoming commended CMS’ efforts to ensure that preparedness plan that includes a procedures, stabilize patients already in providers are prepared for emergencies. process for ensuring cooperation and the facility, transfer patients who However, these commenters disagreed collaboration with local, tribal, regional, require a higher level of care, account with CMS’ proposed emergency state, and federal emergency for all ASC staff and volunteers, and preparedness requirements for ASCs. preparedness official’s efforts to ensure either shelter in place current staff and The commenters stated that the an integrated response during a disaster volunteers or send them home. The proposed requirements are too or emergency situation. The commenters requested that CMS not burdensome and that the current ASC commenters noted that in many finalize this proposal. disaster preparedness requirements in instances, communities do not include Response: We agree with the § 416.41(c) allow providers the ASCs in their emergency preparedness commenters. We understand that most appropriate amount of flexibility during efforts. They recommended that CMS ASCs are highly specialized facilities an emergency. The commenters stated explicitly state that an ASC is in that would not necessarily transfer that ASCs should not be subjected to the compliance with all community-based patients to other ASCs during an same emergency preparedness requirements, as long as the ASC has emergency and, based on this requirements as hospitals. Most of these written documentation of its attempts to understanding of the nature of ASCs, we commenters requested that CMS revise cooperate and collaborate with believe that ASCs should not be the proposed emergency preparedness community organizations, even if the required to establish arrangements with requirements for ASC. Some of these community organizations never other ASCs to transfer and receive commenters recommended that CMS respond. patients during an emergency. not finalize any of the proposed Response: We appreciate the Therefore, we are not finalizing the emergency preparedness requirements commenter’s support. Based on proposed requirement at § 416.54(b)(6). for ASCs. responses from several commenters, we During an emergency, if a patient Response: We understand the are changing the wording of § 416.54(a) requires care that is beyond the commenter’s concerns and we agree for this final rule to state that ASCs capabilities of the ASC, we would with some of the comments that must include a process for maintaining expect that ASCs would transfer suggested that the emergency cooperation and collaboration with patients to a hospital with which the preparedness requirements for ASC local, tribal, regional, state, and federal ASC has a written transfer agreement, as should be modified, and we discuss emergency preparedness officials’ required by existing § 416.41(b), or to these modifications in this rule. efforts to ensure an integrated response the local hospital, that meets the

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requirements of § 416.41(b)(2), where patients, if staff and patients were in the would likely be the result of a patient the ASC physicians have admitting facility during the event of an needing a high level of care, it is not privileges. ASCs should also consider emergency. For reasons discussed reasonable for an ASC to have the in, their risk assessment, alternative earlier, we have removed ‘‘after the contact information for other ASCs in hospitals outside of the area to transfer emergency’’ from the regulations text for their communication plan. Furthermore, patients to, if the hospital with which ASCs. We agree that if an emergency the commenter noted that it is the ASC has a written transfer were to arise, ASCs would have the unreasonable for ASCs to have contact agreement or admitting privileges is also flexibility to cancel appointments and information for a list of emergency affected by the emergency. close. However, we also believe that volunteers. Comment: A commenter stated that emergencies may arise while staff and Other commenters stated that it the proposed rule was unclear about patients are in the ASC. Therefore, we would be reasonable for an ASC to what is expected of ASCs in regards to do not believe the requirement should develop a communication plan that requirements for alternate sources of be removed. Instead, we are revising the would require ASCs to maintain contact energy to maintain temperature, regulations text further to require that if information for those who work at their emergency lighting, and fire detection, any staff or patients are in the ASC facilities and for community emergency extinguishing and alarm systems. during an emergency and transferred preparedness staff. Response: We did not propose elsewhere for continued or additional Response: We disagree with the specific temperature, emergency care, the ASC must document the commenter’s suggestion that ASCs lighting, fire detection, extinguishing specific name and location of the would not be able to develop a and alarm systems, or emergency and receiving facility or other location for communication plan that would include standby power requirements for ASCs. those patients and on-duty staff who are policies to maintain the contact However, ASCs would be expected to relocated during and emergency. We information of the appropriate facility follow all pertinent federal, state, and note that if the ASC is able to close or and emergency preparedness staff. ASCs local law requirements outside of these cancel appointments, there would be no are one of the few provider and supplier regulations. need to track patients or staff. types that already have CfCs for Comment: A commenter was Comment: Several commenters emergency and disaster preparedness. concerned that ASCs would be required expressed concern about whether the They are currently required to maintain to comply with the Emergency communication requirement could be a written disaster preparedness plan Preparedness Checklist: Recommended interpreted to require the use of EHRs in that provides for care of patients and Tool for Effective Health Care Facility ASCs. They noted that ASCs have not staff during an emergency and to Planning, before the final emergency been included in recent federal coordinate the plan with state and local preparedness regulations are published. programs that foster the use of authorities, as appropriate. Therefore, The commenter suggested that the healthcare information technology. A we would expect that these ASC current survey process could be used to commenter noted that almost no ASCs facilities would already have contact collect statistically significant data are equipped with an interoperable EHR information for emergency management regarding the application of the final system that could communicate with authorities and appropriate staff. We rule. other providers and suppliers. believe that, in light of these existing Response: The emergency Response: As finalized, § 416.54(c)(4) requirements, it is feasible for an ASC preparedness checklist that the requires that facilities have a method for to continue to maintain these commenter refers to is a recommended sharing information and medical requirements and include written checklist for emergency preparedness documentation for patients under the documentation for a communication only. We are not requiring ASCs or ASC’s care, as necessary, with other plan. other providers to comply with the healthcare facilities to ensure continuity However, we do agree with the recommendations in this checklist. of care. We are not requiring, nor are we commenters that it may be unreasonable However, ASCs must comply with the endorsing, a specific digital storage for an ASC to maintain the contact emergency preparedness requirements device or technology for sharing information for other ASCs, given the finalized in this rule 1 year after the information and medical highly specialized nature of care in most final rule is published, as discussed in documentation. Furthermore, we are not ASC facilities. The procedures section II.B. of this final rule. requiring facilities to use EHRs or other performed in an ASC vary depending on Comment: We proposed to require methods of electronic storage and the focus of the ASC. Some ASCs ASCs to track their patients and staff dissemination. In this regard, we specialize solely in eye procedures, before and during an emergency. Most acknowledge that some facilities are still while other may specialize in commenters questioned why some of using paper based documentation. orthopedics, plastic surgery, pain the outpatient suppliers, such as CORFs However, we encourage all facilities to treatment, dental, podiatric, urological, and Organizations, were being treated investigate effective ways to secure, etc. Therefore, we are not finalizing our differently and not required to track store, and disseminate medical proposal to require that ASCs maintain their patients and staff during an documentation, as permitted by the the names and contact information for emergency when their services were HIPAA Privacy Rule, to ensure other ASCs in the ASC’s communication vital to their patient populations. continuity of care during an emergency plan. Commenters indicated that similar to or a disaster. Comment: Several commenters these facilities, ASCs also have the Comment: A few commenters stated addressed the proposal that would flexibility to cancel appointments and that the proposed communication plan require ASCs to release patient close in the event of an emergency. requirements would unnecessarily information as permitted under 45 CFR Commenters requested that we remove overburden ASCs. A commenter 164.510 of the HIPAA Privacy Rule and this requirement. indicated specific concerns about ASCs to have a communication system in Response: We proposed this maintaining contact information for place capable of generating timely, requirement for ASCs because we other ASCs and stated that since ASCs accurate information that could be believed an ASC should maintain are not 24-hour care facilities and disseminated, as permitted, to family responsibility for their staff and because a transfer to another facility members and others. The commenters

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stated that this proposal is inappropriate noted that many communities do not and maintains the availability of for the ASC setting. The commenters include ASCs in their emergency records.’’ noted that ASCs should be exempt from preparedness efforts because they are • Removing § 416.54(b)(6) that this requirement, since ASCs do not primarily outpatient facilities that requires that ASCs develop provide continuous care to patients nor provide elective surgery, and are not arrangements with other ASCs and other to patients who are homebound or designed to accommodate an influx of providers to receive patients in the receiving services at home. patients in case of an emergency. event of limitations or cessation of Response: We disagree with the Another commenter noted that the operations to ensure the continuity of commenters’ statement that ASCs proposed rule does allow for ASCs to services to ASC patients, and should be exempt from the proposed conduct a facility-based disaster drill if renumbering paragraph (b)(7) as requirement at § 416.54(c)(6) that ASCs a community drill is not available; paragraph (b)(6). establish in their communication plan a however they stated that a drill of any • Revising § 416.54(c) by adding the means, in the event of an evacuation, to kind would likely impose an additional term ‘‘local’’ to clarify that the ASC release patient information as permitted burden on an ASC due to limited staff. must develop and maintain an under 45 CFR 164.510. While it is true A commenter suggested that ASCs be emergency preparedness that ASCs do not provide continuous allowed to conduct a facility-based communication plan that also complies care to patients, we believe it is still of disaster drill if a community drill is not with local laws. utmost importance for ASCs to be available or if the ASC is not part of a • Revising § 416.54(c)(1)(iv) to prepared to disseminate information community’s emergency preparedness remove the requirement that ASCs about a patient’s status, should an efforts. include the names and contact unforeseen emergency occur while the Response: We recognize the existence information for ‘‘Other ASCs’’ in the ASC is open and in operation. We of a lack of community collaboration in communication plan. believe that ASCs are fully capable of some areas as it relates to emergency • Revising § 416.54(c)(5) to clarify establishing an effective communication preparedness, which is one of the that ASCs must develop a means, in the plan that would allow for the release of reasons we are seeking to establish event of an evacuation, to release patient information in the event of an unified emergency preparedness patient information, as permitted under evacuation. Also, we believe that ASCs standards for all Medicare and Medicaid 45 CFR 164.510(b)(1)(ii). should be prepared to disseminate providers and suppliers. As noted • Revising § 416.54(d) by adding that information on patients under the earlier, we stated in the proposed rule each ASC’s training and testing program ASC’s’ care to family members during that if a community disaster drill is not must be based on the ASC’s emergency an emergency, as permitted under 45 available, we would require an ASC to plan, risk assessment, policies and CFR 164.510(b)(1)(ii). Therefore, it is conduct an individual facility-based procedures, and communication plan. important that ASCs have a plan in disaster drill. We also note that for the • advance of this type of situation that second annual testing requirement we Revising § 416.54(d)(1)(iv) by would entail how the ASC would are revising our testing standards to replacing the phrase ‘‘ensure that staff coordinate this effort to provide patient allow either a community disaster drill can’’ with the phrase ‘‘demonstrate staff.’’ information. For example, if a patient is or a tabletop exercise annually, so an • undergoing a procedure in an ASC and, ASC may opt to conduct a tabletop Revising § 416.54(d)(2)(i) by due to an unforeseen natural disaster, exercise over a facility-based drill. removing the requirement for ASCs to the ASC is forced to evacuate or shelter After consideration of the comments participate in a community-based in place, the ASC should have a system we received on the proposed emergency disaster drill. • in place should they need to use or preparedness requirements for ASCs Revising § 416.54(d)(2) to allow an disclose protected health information to and the general comments we received ASC to choose the type of exercise they notify, or assist in the notification of, a on the proposed rule, as discussed in will conduct to meet the second annual family member, a personal the hospital section (section II.C. of this testing requirement. • representative, or another person final rule), we are finalizing the Adding § 416.54(e) to allow a responsible for the care of the patient of proposed emergency preparedness separately certified ASC within a the patient’s location, general health requirements for ASCs with the healthcare system to elect to be a part condition, or death. We believe patients following modifications: of the healthcare system’s emergency would be ill-served, and ASCs would be • Revising the introductory text of preparedness program. unprepared, if such a situation were to § 416.54 by adding the term ‘‘local’’ to F. Emergency Preparedness Regulations occur without a communication plan clarify that ASCs must also comply with for Hospices (§ 418.113) that establishes means, in the event of local emergency preparedness an evacuation, to release patient requirements. Section 122 of the Tax Equity and information. We note that the • Revising § 416.54(a)(4) to delete the Fiscal Responsibility Act of 1982 requirements of this final rule allow term ‘‘ensuring’’ and to replace the term (TEFRA), Public Law 97–248, added ASCs flexibility to construct a ‘‘ensure’’ with ‘‘maintain.’’ section 1861(dd) to the Act to provide communication plan that best serves the • Revising § 416.54(b)(1) to remove coverage for hospice care to terminally facility’s and their patients’ individual the requirement for ASCs to track all ill Medicare beneficiaries who elect to circumstances. staff and patients after an emergency receive care from a Medicare- Comment: We received several and requiring that if any on-duty staff or participating hospice. Under the comments from the ASC community patients are in the ASC during an authority of section 1861(dd) of the Act, that opposed our proposal to require emergency and transferred or relocated, the Secretary has established the CoPs ASCs to participate in a community the ASC must document the specific that a hospice must meet in order to mock disaster drill at least once a year. name and location of the receiving participate in Medicare and Medicaid The majority of the commenters noted facility or other location. The CoPs found at part 418, subparts C that ASCs are not included in • Revising § 416.54(b)(4)(iii) by and D, apply to a hospice, as well as to emergency preparedness efforts of their replacing the phrase ‘‘ensures records the services furnished to each patient community. A commenter specifically are secure’’ with the phrase ‘‘secures under hospice care.

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Hospices provide palliative care procedures differently from the to their specific needs and rather than traditional medical care and proposed policies and procedures for circumstances, as well as the needs of curative treatment to terminally ill hospitals. Specifically, we proposed to their patients. Specifically for hospice patients. Palliative care improves the group requirements that apply to all providers, we believe that we gave quality of life of patients and their hospice providers at § 418.113(b)(1) much consideration to whether the families facing the problems associated through (5) followed by requirements at hospice was home based or an inpatient with terminal illness through the § 418.113(b)(6) that apply only to hospice. For example, we organized the prevention and relief of suffering by hospice inpatient care facilities. hospice policies and procedures means of early identification, Unlike our proposed hospital policies requirements based on those that apply assessment, and treatment of pain and and procedures, we proposed at to all hospice providers and those that other issues. § 418.113(b)(2) to require all hospices, apply to only hospice inpatient care As of June 2016, there were 412 regardless of whether they operate their facilities. Given the terminally ill status inpatient hospice facilities nationally. own inpatient facilities, to have policies of hospice patients, we continue to Under the existing hospice CoPs, and procedures to inform state and local believe that in an emergency situation hospice inpatient facilities are required officials about hospice patients in need they may be as or more vulnerable than to have a written disaster preparedness of evacuation from their respective their hospital counterparts. This could plan that is periodically rehearsed with residences at any time due to an be due to the inherent severity of the hospice employees, with procedures to emergency situation based on the hospice patient’s illness or to the be followed in the event of an internal patient’s medical and psychiatric probability that the hospice patient’s or external disaster and procedures for condition and home environment. Such caregiver may not have the level of the care of casualties (patients and staff) policies and procedures must be in professional expertise, supplies, or arising from such disasters. This accord with the HIPAA Privacy Rule, as equipment of the hospital-based requirement, which is limited in scope, appropriate. This proposed requirement clinician. We continue to believe that is found at § 418.110(c)(1)(ii) under recognized that many frail hospice the hospital emergency requirement, ‘‘Standard: Physical environment.’’ patients may be unable to evacuate from with some reorganization and revision For hospices, we proposed to retain their homes without assistance during as proposed, is appropriate for all existing regulations at § 418.110(c)(1)(i), an emergency. This additional proposed hospice providers. In addition, we note which state that a hospice must address requirement recognized the that existing hospice regulations at real or potential threats to the health responsibility of the hospice to support § 418.110(c)(1) already require inpatient and safety of the patients, other persons, the safety of its patients that reside in hospice facilities to have a written and property. However, we proposed to the community. disaster preparedness plan. Therefore, incorporate the existing requirements at We note that the proposed we do not agree that an exemption for § 418.110(c)(1)(ii) into proposed requirements for communication at inpatient or outpatient hospice facilities § 418.113(a)(2) and (d)(1). We proposed § 418.113(c) were the same as for is appropriate. to require at § 418.113(a)(2) that the hospitals, with the exception of Comment: A commenter noted that hospice’s emergency preparedness plan proposed § 418.113(c)(7). At inpatient hospice facilities are often include contingencies for managing the § 418.113(c)(7), for hospice facilities, we small in size and free-standing rather consequences of power failures, natural proposed to limit to inpatients the than integrated into larger healthcare disasters, and other emergencies that requirement that the hospice have facilities. The commenter requested that would affect the hospice’s ability to policies and procedures that would we provide flexibility in our provide care. In addition, we proposed include a means of providing requirements based on the size of a to require at § 418.113(d)(1)(iv) that the information about the hospice’s facility. In addition, the commenter hospice periodically review and occupancy and needs, and its ability to indicated that smaller inpatient rehearse its emergency preparedness provide assistance, to the authority hospices do not have institutional plan with hospice employees with having jurisdiction or the Incident kitchens and often contract for the special emphasis placed on carrying out Command Center, or designee. The provision of food. The commenter the procedures necessary to protect proposed requirements for training and questioned whether it is acceptable to patients and others. We proposed that testing at § 418.113(d) were the same as provide readymade meals for patients § 418.110(c)(1)(ii) and the designation those proposed for hospitals. and staff for sheltering in place and for for paragraph (i) of § 418.110(c)(1) be Comment: A commenter stated that it what period of time will hospices be removed. Otherwise, the proposed was unreasonable for home based expected to prepare to provide emergency preparedness requirements hospices to be aligned with or have subsistence needs. for hospice providers were very similar similar emergency preparedness Response: We appreciate the to those for hospitals. requirements as hospitals. Another commenter’s feedback. Where feasible, In the proposed rule, we stated that commenter requested that we exempt we did not propose overly prescriptive despite the key differences between inpatient hospice facilities from meeting requirements for any of the providers hospitals and hospices, we believed the the same emergency standards as and suppliers, regardless of size. We hospital emergency preparedness hospitals. note that we are only requiring facilities requirements, with some reorganization Response: We understand that to have policies and procedures to and revision are appropriate for hospice residential facilities function much address the provision of subsistence in providers. Thus, our discussion focused differently than hospitals; however we the event of an emergency. This could on the requirements as they differed do not believe that we solely aligned the include establishing a relationship with from the requirements for hospitals hospice requirements with hospitals. As a non-profit that provides meals during within the context of the hospice stated in the proposed rule, we disasters. All hospices have the setting. Since hospices serve patients in proposed to develop core components of flexibility to determine and manage the both the community and within various emergency preparedness that could be types, amounts, and needed preparation types of facilities, we proposed to used across provider and supplier types, for providing subsistence needs based organize the requirements for the while tailoring requirements for on their own facility risk assessments. hospice provider’s policies and individual provider and supplier types We believe that allowing each

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individual hospice the flexibility to private residence with access to travel across the emergency response system, identify the subsistence needs that freely. Commenters supported the intent as needed, in the interest of the patient. would be required during an emergency of the requirement, but requested that Comment: A hospice provider agreed is the most effective way to address CMS revise this requirement taking into with the need for a communication plan subsistence needs without imposing consideration the complexity of tracking to be included in the emergency plan, undue burden. patients receiving home-based care. but was unsure whether this should be Comment: A commenter addressed in a separate regulation recommended that the executive team of Response: We understand that we specifically addressing communication. each individual hospice should were not clear in our proposal about our Another commenter supported the determine which staff should intentions as to how hospice providers proposed communication plan participate in the creation of their could meet this requirement. In requirements for hospices and HHAs, emergency preparedness plans, process, addition, after reviewing the issues and noted the importance of and tools. raised by commenters, we agree that communicating information to relevant Response: We thank the commenter further consideration should be given to authorities and facilities about the for their suggestion. We did not indicate variations between inpatient hospices location and condition of vulnerable who must develop the emergency and home based hospices. We agree that individuals, who may have difficulty preparedness plans. All providers and this factor, whether the hospice is evacuating during a disaster or suppliers have the flexibility to inpatient or home based, creates a emergency due to the severity of their determine the appropriate staff that difference in the hospice provider’s illness. should be involved in the development ability to track patients. Therefore, we Response: We appreciate the of their entire emergency preparedness are removing the requirement for home commenters’ support and we agree with program. based hospices to track their staff and the commenters’ point about the Comment: A commenter supported patients. Similar to the revisions we importance of communicating patient our requirement for hospices to develop made for HHA, we are replacing the information, especially for vulnerable procedures to inform State and local tracking requirement with a requirement populations. We believe that it is officials about hospice patients in need for home based hospices to have important that hospice providers of evacuation from their residences due policies and procedures that address the include in their emergency to an emergency situation. However, the follow up procedures the hospice will preparedness plans a communication commenter indicated that for smaller exercise in the event that their services plan that is reviewed and updated hospice providers, developing and are interrupted during or due to an annually. We believe that requirements maintaining a current list of patients in emergency event. In addition, the for a hospice’s communication plan need of evacuation assistance, along hospice must inform state and local should be included in these emergency with the type of assistance required, officials of any on-duty staff or patients preparedness regulations, since we will be a time-consuming manual effort. that they are unable to contact. Similar believe that an emergency preparedness The commenter requested that we to the revisions we made for hospitals, plan for facilities is not complete provide as much flexibility to this we are keeping the requirement for without plans for communicating requirement as possible. inpatient hospices to track staff and during an emergency or disaster. Response: We appreciate the Comment: A few hospice providers patients during an emergency, but commenter’s support and feedback. We expressed concern about the proposed removing the language ‘‘after the disagree with the statement that it communication plan for hospices with emergency’’ from the regulation text. would be overly burdensome for respect to federal and state funding and Instead we are revising the text to clarify hospices to maintain a current list of support. patients and their needs of assistance. that in the event that on-duty staff or A commenter stated that most We also note that we did not limit the patients are relocated during an hospices do not have access to funding way in which hospices have to collect, emergency, the inpatient hospice must to purchase communication networks maintain, or share this information. As document the specific name and that link to first responders, hospitals, a best practice, most hospices, location of the receiving facility or other and county/regional Incident Command regardless of size, maintain an up-to- location for on-duty staff and patients Centers. They stated that, aside from date list of their current patients for who leave the facility during the land lines and cell phones if they are organizational purposes and to maintain emergency (that is, another facility, available, communication could be very operations. In addition, we believe that alternate sheltering location, etc.). We challenging, if not impossible. Another it is current practice for staff to make expect that for administrative purposes, commenter stated that it would take daily assessments of the needs and all hospices already have some more time, and more federal and state capabilities of their hospice patients. mechanism in place to keep track of support, for hospice providers to meet We would also assume that the smaller patients and staff contact information. the proposed requirements. the hospice, the smaller the number of In addition, we expect that as a best Response: We thank the commenters patients they would need to assess and practice, all hospices will find it for their feedback. We understand the document. We continue to believe that necessary to communicate and follow commenters’ concerns about means of it is critically important that hospices up with their patients during or after an communication for hospice providers have a way to share this information interruption in their services to close and refer readers to various with State and local officials. the loop on what services are needed communication planning resources, Comment: Specific to hospices, and can still be provided. All hospices including http://www.hhs.gov/ocio/ea/ commenters were unclear about what it will have the flexibility to determine National%20Communication%20 would mean for a hospice to track how best to develop these procedures, System/ (The National Communication patients from setting to setting during an whether they utilize an electronic System) and those resources referenced emergency. For those home-based communication or some other method. in the proposed rule and this final rule. hospices, commenters noted that unlike We expect that the information would We expect facilities to develop and an institutional setting, hospice patients be readily available, accurate, and maintain policies and procedures for reside in the community and their shareable among officials within and patient care and their overall operations.

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The emergency preparedness • Revising § 418.113(a)(4) to delete G. Emergency Preparedness Regulations requirement may increase costs in the the term ‘‘ensuring’’ and to replace the for Psychiatric Residential Treatment short term because resources would term ‘‘ensure’’ with ‘‘maintain.’’ Facilities (PRTFs) (§ 441.184) have to be devoted to the assessment • Revising § 418.113(b)(1) to remove and development of an emergency plan the requirement for home-based Sections 1905(a)(16) and (h) of the Act that utilizes an all-hazards approach. hospices to track staff and patients. define the term ‘‘Psychiatric Residential While the proposed requirements could • Revising 418.113(b)(1) to clarify Treatment Facility’’ (PRTF) and list the result in some immediate costs to a that in the event that there is an requirements that a PRTF must meet to provider or supplier, we believe that interruption in services during or due to be eligible for Medicaid participation. developing an emergency preparedness an emergency, home based hospices To qualify for Medicaid participation, a program would be beneficial overall to must have policies in place for PRTF must be certified and comply with any provider or supplier. In addition, following up with on-duty staff and conditions of payment and CoPs, at we believe that planning for the patients to determine services that are §§ 441.150 through 441.182 and protection and care of patients, clients, still needed. In addition, they must §§ 483.350 through 483.376 residents, and staff during an emergency inform State and local officials of any respectively. As of June 2016, there or a disaster is a good business practice. on-duty staff or patients that they are were 377 PRTFs. Comment: A few commenters unable to contact. A PRTF provides inpatient expressed their concern about our • Revising § 418.113(b)(5) to delete psychiatric services for patients under proposal to require hospices to the term ‘‘ensure’’ and to replace it with age 21. Under Medicaid, these services participate in both a community mock the term ‘‘maintain.’’ must be provided under the direction of disaster drill and a paper based tabletop • Revising § 418.113(b)(6)(iii)(A) by a physician. Inpatient psychiatric exercise. Mainly, the commenters adding that hospices must have policies services must involve active treatment acknowledged the benefits and and procedures that address the need to which means implementation of a necessity of participating in drills and sustain pharmaceuticals during an professionally developed and exercises to determine the effectiveness emergency. supervised individual plan of care. The of an emergency plan, but stated that • Revising § 418.113(b)(6) by adding a patient’s plan of care includes an conducting drills and exercises in the new paragraph (v) to require that integrated program of therapies, hospice setting is time consuming and inpatient hospices track on-duty staff activities, and experiences designed to would disrupt and compromise patient and patients during an emergency, and, meet individual treatment objectives care. in the event staff or patients are that have been developed by a team of Response: We agree that patient care relocated, inpatient hospices must professionals along with the patient, his is always the priority; however we document the specific name and or her parents, legal guardians, or others believe that requiring staff to participate location of the receiving facility or other into whose care the patient will be in training once a year is reasonable. location to which on-duty staff and released after discharge. The plan must Since the training will be anticipated, patients were relocated to during the also include post-discharge plans and we believe that it would be possible for emergency. coordination with community resources staff to work with their patients to • Revising § 418.113(c) by adding the to ensure continued services for the adjust their schedules accordingly in term ‘‘local’’ to clarify that the hospice patient, his or her family, school, and order to participate in any such training. must develop and maintain an community. Emergency preparedness testing and emergency preparedness The current PRTF requirements do training could be consolidated with communication plan that also complies not include any requirements for other hospice training to reduce the with local laws. • emergency preparedness. We proposed impact and address staffing limitations. Revising § 418.113(c)(5) to clarify to require that PRTF facilities meet the In addition, we believe that our decision that hospices must develop a means, in same requirements we proposed for to change our proposal to allow for the event of an evacuation, to release hospitals. Because these facilities vary either a community disaster drill or a patient information, as permitted under widely in size, we would expect that tabletop exercise annually for the 45 CFR 164.510(b)(1)(ii). their emergency preparedness risk second annual testing requirement will • Revising § 418.113(d) by adding assessments, emergency plans, policies provide hospices with the flexibility to that each hospice’s training and testing and procedures, communication plan, determine which testing drill or exercise program must be based on the hospice’s and training and testing will vary would be most beneficial to their emergency plan, risk assessment, widely as well. However, we believe organization, taking into consideration policies and procedures, and PRTFs have the capability to comply factors such as staff limitations and communication plan. fully with emergency preparedness financial cost. • Revising § 418.113(d)(1)(ii) to requirements so that the health and After consideration of the comments replace the phrase ‘‘Ensure that hospice safety of its patients are protected in the we received on the proposed emergency employees can demonstrate’’ to event of an emergency situation or preparedness requirements for hospices, ‘‘Demonstrate staff.’’ and the general comments we received • Revising § 418.113(d)(2)(i) by disaster. on the proposed rule, as discussed in replacing the term ‘‘community mock Comment: A commenter questioned if the hospital section (section II.C. of this disaster drill’’ with ‘‘full-scale exercise.’’ a generator would be required to be final rule), we are finalizing the • Revising § 418.113(d)(2) to allow a used as an alternate source of energy. proposed emergency preparedness hospice to choose the type of exercise it Response: Emergency and standby requirements for hospices with the will conduct to meet the second annual power systems are not a requirement for following modifications: testing requirement. PRTFs. That requirement applies only to • Revising the introductory text of • Adding § 418.113(e) to allow hospitals, CAHs and LTC facilities. § 418.113 by adding the term ‘‘local’’ to separately certified hospices within a Alternate sources of energy could clarify that hospices must also healthcare system to elect to be a part include, for example, propane, gas, and coordinate with local emergency of the healthcare system’s emergency water-generated systems, in addition to preparedness requirements. preparedness program. other resources.

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Comment: A commenter stated that it require a PRTF to conduct an individual • Revising § 441.184(d)(2)(i) by would be difficult for PRTFs, ICFs/IIDs, facility-based disaster drill/full-scale replacing the term ‘‘community mock and CMHCs to implement a method to exercise. A PRTF is expected to disaster drill’’ with ‘‘full-scale exercise.’’ share patient information and medical document its efforts to participate in a • Revising § 441.184(d)(2)(ii) to allow documentation with other healthcare community disaster drill; however, the a PRTF to choose the type of exercise it facilities to ensure continuity of care, requirement to conduct a facility-based will conduct to meet the second annual since these entities are not uniformly disaster drill/full-scale exercise would testing requirement. using electronic health records. still need to be met. • Adding § 441.184(e) to allow a Therefore, the commenter After consideration of the comments separately certified PRTF within a recommended flexibility in the we received on the proposed emergency healthcare system to elect to be a part implementation of these requirements. preparedness requirements for PRTFs, of the healthcare system’s emergency The commenter also noted that the and the general comments we received preparedness program. CMS proposed rule stated that PRTFs on the proposed rule in the hospital H. Emergency Preparedness Regulations are not likely to have formal section (section II.C. of this final rule), for Programs of All-Inclusive Care for communication plans. However, the we are finalizing the proposed the Elderly (PACE) (§ 460.84) commenter stated that PRTFs accredited emergency preparedness requirements The Balanced Budget Act (BBA) of by TJC are subject to Standard for PRTFs with the following 1997 established the Program of All- EM.02.02.01, which requires that the modifications: Inclusive Care for the Elderly (PACE) as organization include in an emergency • Revising the introductory text of a permanent Medicare and Medicaid preparedness plan details on how the § 441.184 by adding the term ‘‘local’’ to facility will communicate during provider type. Under sections 1894 and clarify that PRTFs must also comply 1934 of the Act, a state participating in emergencies. with local emergency preparedness Response: We believe that we have PACE must have a program agreement requirements. with CMS and a PACE organization. allowed for flexibility in how PRTFs • Revising § 441.184(a)(4) to delete develop and maintain their Regulations at § 460.2 describe the the term ‘‘ensuring’’ and to replace the statutory authority that permits entities communication plans. However, if the term ‘‘ensure’’ with ‘‘maintain.’’ commenter is referring to flexibility in to establish and operate PACE programs • Revising § 441.184(b)(1)(i) by when these requirements will be under section 1894 and 1934 of the Act adding that PRTFs must have policies implemented, we refer the commenter and § 460.6 defines a PACE organization and procedures that address the need to to the section of this final rule that as an entity that has in effect a PACE sustain pharmaceuticals during an implements an effective date that is 1 program agreement. Sections 1894(a)(3) emergency. and 1934(a)(3) of the Act define a year after the effective date of this final • rule for these emergency preparedness Revising § 441.184(b)(2) by ‘‘PACE provider.’’ The PACE model of requirements for all providers and clarifying that tracking during and after care includes the provision of adult day suppliers. the emergency applies to on-duty staff healthcare and interdisciplinary team In addition, we acknowledge that and sheltered residents. We have also care management as core services. some PRTFs may already have revised paragraph (b)(2) to provide that Medical, therapeutic, ancillary, and communication plans in place, as if on-duty staff and sheltered residents social support services are furnished in required as a condition of TJC are relocated during the emergency, the the patient’s residence or on-site at a accreditation. We appreciate the facility must document the specific PACE center. Hospital, nursing home, commenter’s feedback and note that name and location of the receiving home health, and other specialized facilities that meet TJC accreditation facility or other location. services are furnished under contract. A • standards should be well-equipped to Revising § 441.184(b)(5) to change PACE organization provides medical comply with the communication plan the phrase ‘‘ensures records are secure and other support services to patients requirements established in these CoPs. and readily available’’ to ‘‘secures and predominantly in a PACE adult day care Comment: In response to our maintain availability of records.’’ center. As of June 2016, there are 119 proposed requirement for a PRTF to • Revising § 441.184(b)(7) to replace PACE programs nationally. participate in a community disaster the term ‘‘ensure’’ with ‘‘maintain.’’ Regulations for PACE organizations at drill, we received one comment which • Revising § 441.184(c) by adding the part 460, subparts E through H, set out stated that PRTFs are often not included term ‘‘local’’ to clarify that the PRTF the minimum health and safety in their larger community’s must develop and maintain an standards a facility must meet in order preparedness plan. The commenter emergency preparedness to obtain Medicare certification. The stated that the lack of inclusion often communication plan that also complies current CoPs for PACE organizations occurs despite the willingness and with local laws. include some requirements for request on the part of the PRTF. The • Revising § 441.184(c)(5) to clarify emergency preparedness. We proposed commenter recommended that we allow that PRTFs must develop a means, in to remove the current PACE documentation of best efforts to be a the event of an evacuation, to release organization requirements at part of the community disaster drill to patient information, as permitted under § 460.72(c)(1) through (5) and meet this requirement. 45 CFR 164.510(b)(1)(ii). incorporate these existing requirements Response: We recognize the existence • Revising § 441.184(d) by adding into proposed § 460.84, Emergency of a lack of community collaboration in that each PRTF’s training and testing preparedness requirements for Programs some areas as it relates to emergency program must be based on the PRTF’s of All-Inclusive Care for the Elderly preparedness, which is one of the emergency plan, risk assessment, (PACE). reasons why we are seeking to establish policies and procedures, and Currently § 460.72(c)(1), Emergency unified emergency preparedness communication plan. and disaster preparedness procedures, standards for Medicare and Medicaid • Revising § 441.184(d)(1)(iii) to states that the PACE organization must providers and suppliers. We stated in replace the phrase ‘‘ensure that staff can establish, implement, and maintain the proposed rule that if a community demonstrate’’ to ‘‘Demonstrate staff documented procedures to manage disaster drill is not available, we would knowledge.’’ medical and nonmedical emergencies

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and disasters that are likely to threaten proposed PACE emergency community assessments, then there is the health or safety of the patients, staff, preparedness requirements was that we no need to include this in their or the public. Currently § 460.72(c)(2) proposed adding at § 460.84(b)(4) a emergency plan. defines emergencies to include, but not requirement for a PACE organization to Comment: A few commenters, be limited to: Fire; equipment, water, or have policies and procedures to inform including a PACE association and PACE power failure; care-related emergencies; state and local officials at any time providers, requested further clarification and natural disasters likely to occur in about PACE patients in need of on the requirement that PACE the organization’s geographic area. evacuation from their residences due to organizations develop and maintain We proposed incorporating the an emergency situation, based on the emergency preparedness language from § 460.72(c)(1) into patient’s medical and psychiatric communication plans that provide § 460.84(b). Existing § 460.72(c)(2), conditions and home environment. ‘‘well-coordinated’’ participant care which defines various emergencies, Such policies and procedures must be both within the affected facilities as would be incorporated into § 460.84(b) in accord with the HIPAA Privacy Rule, well as across public health as well. We did not add the statement as appropriate. departments and emergency systems. in current § 460.72(c)(2), that ‘‘an Finally, the third difference between The commenters stated that it would be organization is not required to develop the proposed requirements for hospitals helpful to have a defined ‘‘checklist’’ by emergency plans for natural disasters and the proposed requirements for which PACE organizations could that typically do not affect its PACE organizations was that, at determine whether or not they are geographic location’’ because we § 460.84(c)(7), we proposed to require meeting the requirements to be proposed that PACE organizations these organizations to have a considered ‘‘well-coordinated.’’ utilize an ‘‘all-hazards’’ approach at communication plan that includes a Response: We recognize the § 460.84(a)(1). means of providing information about importance of this inquiry and suggest Existing § 460.72(c)(3), which states their needs and their ability to provide that facilities look to the forthcoming that a PACE organization must provide assistance to the authority having interpretive guidelines after the appropriate training and periodic jurisdiction or the Incident Command publication of this final rule for more orientation to all staff (employees and Center, or designee. We did not propose information. We also continue to contractors) and patients to ensure that requiring these organizations to provide encourage facilities to seek guidance staff demonstrate a knowledge of information regarding their occupancy, from the many emergency preparedness emergency procedures, including as we proposed for hospitals resources we have included in the informing patients what to do, where to (§ 482.15(c)(7)), since the term proposed and final rules. go, and whom to contact in case of an ‘‘occupancy’’ refers to occupancy in an After consideration of the comments emergency, would be incorporated into inpatient facility. we received on the proposed emergency proposed § 460.84(d)(1). The existing Comment: Several commenters, preparedness requirements for PACE requirements for having available including PACE providers, opposed our organizations, and the general emergency medical equipment, for proposal to require PACE organizations comments we received on the proposed having staff who know how to use the to provide for the subsistence needs of rule, as discussed in the hospital section equipment, and having a documented staff and participants whether they (section II.C. of this final rule), we are plan to obtain emergency medical evacuated or sheltered in place during finalizing the proposed emergency assistance from outside sources in an emergency; while other providers preparedness requirements for PACEs current § 460.72(c)(4) would be stated that to do so would be a proactive with the following modifications: relocated to proposed § 460.84(b)(9). measure to provide provisions for even • Revising the introductory text of Finally, current § 460.72(c)(5), which a short amount of time. Some providers § 460.84 by adding the term ‘‘local’’ to states that the PACE organization must stated that these provisions should be clarify that PACE organizations must test the emergency and disaster plan at available to this medically vulnerable, also coordinate with local emergency least annually and evaluate and at-risk population during an emergency preparedness requirements. document its effectiveness would be or if shelter in place occurred for a • Revising § 460.84(a)(4) to delete the addressed by proposed § 460.84(d)(2). period of time. term ‘‘ensuring’’ and to replace the term The current version of § 460.72(c)(1) Response: We appreciate the variety ‘‘ensure’’ with ‘‘maintain.’’ through (5) would be removed. of responses we received. Based on the • Adding § 460.84(b)(1) to address We proposed that PACE organizations comments we received suggesting we subsistence needs, and renumbering the adhere to the same requirements for include this requirement, we are now rest of the section accordingly. emergency preparedness as hospitals, adding a requirement that PACE • Revising § 460.84(b)(2) by clarifying with three exceptions. We did not organizations must have policies and that tracking during and after the propose that PACE organizations procedures in place to address emergency applies to on-duty staff and provide for basic subsistence needs of subsistence needs. sheltered participants. We have also staff and patients, whether they Comment: A commenter wanted us to revised paragraph (b)(2) to provide that evacuate or shelter in place, including define the term ‘‘all-hazards’’ for PACE if on-duty staff and sheltered food, water, and medical supplies; organizations. Another commenter participants are relocated during the alternate sources of energy to maintain requested clarification when facility- emergency, the facility must document temperatures to protect patient health based and community-based the specific name and location of the and safety and for the safe and sanitary assessments are assessed at a ‘‘zero receiving facility or other location. storage of provisions; emergency risk’’, if this would need to be included • Revising § 460.84(b)(5) to change lighting; and fire detection, in their emergency plan. the phrase ‘‘ensures records are secure extinguishing, and alarm systems; and Response: The definition of ‘‘all- and readily available’’ to ‘‘secures and sewage and waste disposal as we hazards’’ is discussed under the maintains availability of records;’’ also proposed for hospitals at § 482.15(b)(1). requirements for hospitals and this revising paragraph (b)(7) to change the The second difference between the definition applies to all provider and term ‘‘ensure’’ to ‘‘maintain.’’ proposed hospital emergency supplier types. If there is an assessed • Revising § 460.84(c) by adding the preparedness requirements and the zero risk made during the facility and term ‘‘local’’ to clarify that the PACE

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organization must develop and maintain There are 770 Medicare-approved This requirement would be applicable an emergency preparedness transplant centers. These centers to inpatient providers since the communication plan that also complies provide specialized services that are not overnight provision of care could be with local laws. available at all hospitals. Thus, we challenged in an emergency. The • Revising § 460.84(c)(5) to clarify believe that it is crucial for every hospital in which the transplant center that the PACE organization must transplant center to work closely with is located would be required under develop a means, in the event of an the hospital in which it is located and § 482.15 to provide for any transplant evacuation, to release patient the designated organ procurement patients and living donors that are information, as permitted under 45 CFR organization (OPO) for that donation hospitalized during an emergency. 164.510(b)(1)(ii). service area (DSA) (unless the hospital Comment: Commenters stated that the • Revising § 460.84(d) by adding that has a waiver approved by the Secretary proposed requirement for transplant each PACE organization’s training and to work with another OPO) in preparing centers to have an agreement with at testing program must be based on the for emergencies so that it can continue least one other Medicare-approved PACE organization’s emergency plan, to provide transplantation and transplant center to provide risk assessment, policies and transplantation-related services to its transplantation services and related care procedures, and communication plan. patients during an emergency. for its patients during an emergency was • Revising § 460.84(d)(1)(iii) to We proposed to add a new transplant unnecessary. They noted that transplant replace the phrase ‘‘Ensure that staff can center CoP at § 482.78, ‘‘Emergency centers have a long history of demonstrate knowledge’’ to preparedness.’’ Proposed § 482.78(a) cooperating with each other during ‘‘Demonstrate staff knowledge.’’ would require a transplant center to emergencies, such as during Hurricanes • Revising § 460.84(d)(2)(i) by have an agreement with at least one Katrina and Rita. A commenter noted replacing the term ‘‘community mock other Medicare-approved transplant that they had never heard of any center to provide transplantation transplant center that failed to ensure disaster drill’’ with ‘‘full-scale exercise.’’ services and other care for its patients that its patients received appropriate • Revising § 460.84(d)(2)(ii) to allow a during an emergency. We also proposed care during an emergency. Many PACE organization to choose the type of at § 482.78(a) that the agreement commenters noted that the Organ exercise it will conduct to meet the between the transplant center and Procurement and Transplantation second annual testing requirement. • another Medicare-approved transplant Network (OPTN) already has emergency Adding § 460.84(e) to allow a center that agreed to provide care during preparedness requirements and that we separately a certified PACE organization an emergency would have to address, at should rely on the OPTN and the United within a healthcare system to elect to be a minimum: (1) The circumstances Network for Organ Sharing (UNOS) to a part of the healthcare system’s under which the agreement would be work with transplant centers during emergency preparedness program. activated; and (2) the types of services emergencies. Specifically, OPTN Policy I. Emergency Preparedness Regulations that would be provided during an 1.4.A Regional and National for Transplant Centers (§ 482.78) emergency. Emergencies, which was effective on Currently, under the transplant center September 1, 2014, states that ‘‘[d]uring All transplant centers are located CoP at § 482.100, Organ procurement, a a regional or national emergency, the within hospitals. Any hospital that transplant center is required to ensure OPTN contractor will attempt to furnishes organ transplants and other that the hospital in which it operates distribute instructions to all transplant medical and surgical specialty services has a written agreement for the receipt hospitals and OPOs that describe the for the care of transplant patients is a of organs with the hospital’s designated impact and how to proceed with organ transplant hospital (42 CFR 482.70). OPO that identifies specific allocation, distribution, and Therefore, transplant centers must meet responsibilities for the hospital and for transplantation’’ (accessed at http:// all hospital CoPs at §§ 482.1 through the OPO with respect to organ recovery optn.transplant.hrsa.gov/Content 482.57 (as set forth at § 482.68(b)), and and organ allocation. We proposed at Documents/OPTN_Policies.pdf#named the hospitals in which they are located § 482.78(b) to require transplant centers dest=Policy_01 on February 24, 2015). must meet the provisions of § 482.15. to ensure that the written agreement Additional policies instruct transplant The transplant hospital would be required under § 482.100 also addresses centers and OPOs to contact the OPTN responsible for the emergency the duties and responsibilities of the contractor for instructions when the preparedness program for the entire hospital and the OPO during an transportation of organs is either not hospital as set forth in § 482.15, emergency. We included a similar possible or severely impaired (OPTN including the transplant center. In requirement for OPOs at § 486.360(c) in Policy 1.4.B), and when communication addition, unless otherwise specified, the proposed rule. We anticipated that through the internet or telephone is not heart, heart-lung, intestine, kidney, the transplant center, the hospital in possible (OPTN Policies 1.4.C, 1.4.D, liver, lung, and pancreas transplant which it is located, and the designated and 1.4.E). If any additional emergency centers must meet all requirements for OPO would collaborate in identifying preparedness requirements are transplant centers at §§ 482.72 through their specific duties and responsibilities necessary, those requirements should be 482.104. during emergency situations and under the auspices of the OPTN and Transplant centers are responsible for include them in the agreement. UNOS or coordinated by these providing organ transplantation services We did not propose to require organizations. from the time of the potential transplant transplant centers to provide basic Response: We agree with the candidate’s initial evaluation through subsistence needs for staff and patients, commenters that transplant centers have the recipient’s post-transplant follow-up as we are proposing for hospitals at a long history of working well with each care. In addition, if a center performs § 482.15(b)(1). Also, we did not propose other. However, we also believe that living donor transplants, the center is to require transplant centers to transplant centers need to be proactive responsible for the care of the living separately comply with the proposed and make at least certain basic donor from the time of the initial hospital requirement at § 482.15(b)(8) preparations for emergency situations. evaluation through post-surgical follow- regarding alternate care sites identified The OPTN does have emergency up care. by emergency management officials. preparedness requirements. However,

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those requirements are not burden on transplant centers, patients, Comment: Some commenters comprehensive, and we do not believe and their families will be less than expressed concerns about how they are sufficient. For example, those estimated burden in the proposed rule. transferring transplant recipients and policies cover the transportation of See section III.I. of this final rule those on the waiting lists to another organs and communication (Collection of Information transplant center would affect both interruptions between the OPTN Requirements, ICRs Regarding these patients and those at the receiving contractor and transplant centers and Condition of Participation: Emergency transplant center. Since each transplant OPOs. They do not cover local Preparedness for Transplant Centers program develops its own patient emergencies or even common (§ 482.78)) for our revised burden selection criteria and, if the transplant emergency situations, such as weather- estimate. center performs living donor related events in which a transplant Comment: Many commenters believed transplants, living donor selection center may have a disruption in power that agreements for emergency criteria, this could result in some or in getting its staff into the hospital. preparedness between transplant patients not being acceptable to the In addition, including emergency centers would be of little value. Since transplant center that agrees to care for preparedness requirements in the the affected area during any particular patients from another transplant center transplant CoPs provides us with emergency is unknown ahead of time, that is experiencing an emergency. A oversight and enforcement authority the transplant center may have an commenter noted that OPTN Policy and imposes the requirements on agreement with another transplant 3.4B prohibits transplant hospitals from transplant programs that received their center that is also affected by the same registering a candidate on a waiting list designation by virtue of their approval emergency. They also noted that, since for an organ if that transplant center for reimbursement for Medicare. The the circumstances of each natural and does not have current OPTN approval requirements finalized in this rule also man-made disaster would be different, for that type of organ (accessed at http:// should not conflict with the OPTN any plans made ahead of time may be optn.transplant.hrsa.gov/Content policies on emergency preparedness. unworkable during an actual Documents/OPTN_Policies.pdf#named Comment: Some commenters stated emergency. They noted that, in each dest=Policy_01 on February 24, 2015). that complying with the proposed emergency, the affected geographic area In addition, depending upon the length requirements would be overly has to be taken into consideration, in of time of the emergency, there could be burdensome. Commenters indicated our addition to the services and patients issues regarding how the waiting list burden estimates were extremely affected. In addition to being of little patients would be integrated with the conservative and that the proposed value, they noted that emergency plans receiving transplant center’s own agreements in § 483.78 could require may provide a false sense of security. waiting list patients. There was some more than 100 hours, especially for Also, in some areas of the country, the concern that, depending on how the hospitals with multiple transplant great geographical distances between transfer was conducted, some of the programs, and perhaps as many as 200 transplant centers would make transferring waiting list patients could contracts. In addition, some commenters agreements with another center both receive preferential treatment over the also indicated that the proposed overly burdensome and impractical. receiving transplant center’s waiting list requirements would result in increased patients. Also, there were some financial burden to patients and their Response: We believe that emergency preparedness is essential for healthcare concerns about how patient records or families. other relevant information would be Response: We agree with the entities. Also, emergency preparedness transferred. In addition, there was a commenters. In analyzing the comments plans should be flexible enough to allow concern about whether CMS and the we received for the transplant center for emergencies that affect both the local OPTN would grant any exceptions or requirements, we now believe that some area, as well emergencies that may affect of these requirements, especially the a larger area, such as regional and modifications to the required statistics proposed requirement for the transplant national emergencies. However, we do and outcome measures during an center to have an agreement with agree with the commenters that the great emergency, especially if the transferring another transplant center, would likely geographical distances between some of patients do not meet the receiving require more resources than we the transplant centers could result in facility’s selection criteria. originally estimated. There is also a making agreements between the centers Response: We agree that there could possibility that there could be some burdensome and impractical. Therefore, be issues when patients are transferred increase in costs to patients and their we are not finalizing the requirement for from one transplant center to another. families. Therefore, we are not finalizing agreements with between transplant However, our requirements do not these requirements as proposed for centers as proposed. Instead, based on oblige a transplant center that agrees to transplant centers to have agreements our analysis of the comments, we have care for another transplant center’s with other transplant centers or for the decided to require that transplant patients during an emergency to put transplant center to ensure that the centers be actively involved in their those patients on its waiting lists. We agreement between the hospital in hospital’s emergency planning and anticipate that most emergencies would which it is located and the OPO programming. We believe this be of short duration and that the addresses the hospital and the OPO’s requirement will ensure that the needs transplant center that is affected by an duties and responsibilities during an of each transplant center are addressed emergency will resume its normal emergency in the agreement required by in the hospital’s program. Also, operations within a short period of time. § 486.100, as required in proposed transplant centers must be involved in However, if a transplant center does § 482.78. Instead, we are finalizing the development of mutually-agreed arrange for its patients to be transferred requirements for transplant centers, the upon protocols that addresses the duties to another transplant center during an hospitals in which they are located, and and responsibilities of the hospital, emergency, both transplant centers the relevant OPOs in developing and transplant program, and OPO during would need to determine what care maintaining protocols that address the emergencies. These changes are would be provided to the transferring duties and responsibilities of each party discussed in more detail later in this patients, including whether and under during an emergency. We believe the final rule. what circumstances the patients from

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the transferring transplant center would to any emergency. Also, as stated and OPO’s duties and responsibilities be added to the receiving center’s earlier, the OPTN’s policies are not during an emergency. waiting lists. comprehensive. For example, they do Comment: Some commenters Concerning exceptions or not cover local emergencies or the other recommended that, instead of requiring modifications to the required statistics specific requirements in this final rule, agreements between transplant centers and outcome measures for operations that is, requirements for a risk and OPOs as we had proposed, we during an emergency, we believe that is assessment, specific policies and should require hospitals, transplant beyond the scope of this final rule. We procedures, an emergency plan, a centers, and OPOs to develop mutually would note that the current survey, communication plan, and training and agreed-upon protocols for addressing certification, and enforcement testing. In addition, as described earlier, emergency situations. These procedures already provide for including emergency preparedness commenters pointed out that since we transplant centers to request requirements in the transplant center proposed that emergency plans be consideration for mitigating factors in CoPs provides us with oversight and reviewed and updated annually and that both the initial and re-approval enforcement authority we do not have changes be incorporated based upon processes for their center as set forth in for the OPTN policies. new information, protocols would be § 488.61(f). In addition, there are Comment: A few commenters stated more conducive to timely and effective specific requirements for requests that the proposed transplant center improvement. Other commenters noted related to natural disasters and public requirements were unnecessary. The that certain factors that would need to health emergencies (§ 488.61(f)(2)(vii)). transplant center should be embedded be considered in an emergency, Comment: Some commenters in the hospital’s overall emergency plan particularly the different facility- expressed concern that our proposed so that transplant patients would be specific levels of service, geographically requirements would interfere with or considered along with all of the other based hazards, and donor potentials, contradict OPTN policies. A commenter patients in the hospital. Another were inappropriate for formal specifically noted that, in the preamble commenter suggested that this agreements but were well suited for to the proposed rule, we stated that agreement not be between different protocols. ‘‘[i]deally, the Medicare-approved Response: We agree with the transplant centers but the hospitals in transplant center that agrees to provide commenters. We believe that mutually which they are located, or even part of care for a center’s patients during an agreed-upon protocols between the a larger or regional emergency plan. emergency would perform the same transplant centers, the hospitals in type of organ transplant as the center Response: We agree with the which the transplant centers operate, seeking the agreement. However, we commenters that the transplant center’s and the OPOs are the best approach to recognize that this may not always be emergency preparedness plans should address emergency preparedness for feasible. Under some circumstances, a be included in the hospital’s emergency these facilities. Therefore, we are not transplant center may wish to establish plans. All of the Medicare-approved finalizing the requirement at proposed an agreement for the provision of post- transplant centers are located within § 482.78 that a transplant center or the transplant care and follow-up for its hospitals and, as part of the hospital, hospital in which it operates have an patients with a center that is Medicare- should be included in the hospital’s agreement with another transplant approved for a different organ type’’ (78 emergency preparedness plans. In center, or the requirement that the FR 79108). The commenter noted that addition, if transplant centers were agreement required at § 486.100 include OPTN Policy 3.4.B states that required to separately comply with all the duties and responsibilities of the ‘‘[m]embers are only permitted to of the requirements in § 482.15, it would OPO and hospital during an emergency. register a candidate on the waiting list be tremendously burdensome to the Instead, we have revised the for an organ at a transplant program if transplant centers. For example, we requirements for transplant centers, the the transplant program has current believe that the transplant center needs hospitals in which they operate, and OPTN transplant program approval for to be involved in the hospital’s risk OPOs to specify that these facilities that organ type.’’ assessment because there may be risks must have mutually agreed-upon Response: We disagree with the to the transplant center that others in protocols that state the duties and commenters. We do not expect any the hospital may not be aware of or responsibilities of each during an transplant center to violate any of the appreciate. However, most of the risk emergency. We believe this approach OPTN’s policies. We are not finalizing assessment would be the same since the will not only achieve our goal of having the proposed requirement for transplant transplant center is located in the these facilities prepared for emergencies centers to have agreements with another hospital; a separate risk assessment but will also impose only minimal transplant center because we now would unnecessary and overly burden. Section 486.344(d) currently believe that requirement may be burdensome. Therefore, we have requires that OPOs have protocols with burdensome and impractical for some modified § 482.68(b) so that transplant transplant centers and § 482.100 transplant centers as we have discussed centers are exempt from the emergency requires that transplant centers ensure earlier. However, if a transplant center preparedness requirements in § 482.15 that the hospitals in which they operate choses to have an agreement with and added a requirement in § 482.15(g) have written agreements for the receipt another transplant center to care for its that requires transplant hospitals to of organs with an OPO designated by patients during an emergency, there is have a representative from each the Secretary that identifies specific no requirement for the receiving center transplant center actively involved in responsibilities for the hospital and for to place those patient on its waiting the development and maintenance of the OPO with respect to organ recovery lists. The receiving transplant center the hospital’s emergency preparedness and organ allocation according to would likely only provide care for the program. In addition, transplant centers § 482.100. In addition, since most, if not duration of the emergency and then would still be required to have their all, of these facilities must have those patients would return to their own emergency preparedness policies previously encountered emergencies, original transplant center. However, and procedures, as well as participate in we believe that establishing these what care was to be provided should be mutually-agreed upon protocols that protocols should require a much smaller decided by the transplant centers prior address the transplant center, hospital, burden than developing an agreement.

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After consideration of the comments through (d) of the Act. A LTC facility power load the LTC facility anticipates we received on those changes in the may be both Medicare and Medicaid it would require during an emergency. proposed rule, as discussed earlier and approved. However, we also solicited comments in the hospital section (section II.C. of LTC facilities provide a substantial on whether there should be a specific this final rule), we are finalizing the amount of care to Medicare and requirement for ‘‘residents’ power proposed emergency preparedness Medicaid beneficiaries, as well as needs’’ in the LTC requirements. requirements for transplant centers with ‘‘dually eligible individuals’’ who Comment: Some commenters the following modifications: qualify for both Medicare and Medicaid. recommended that LTC facilities be • Adding a requirement at § 482.15(g) As of June 2016, there were 15,699 LTC required to include patients, their that a transplant center be actively facilities and these facilities provided families, and relevant stakeholders involved in the hospital’s emergency care for about 1.7 million patients. throughout the emergency preparedness preparedness planning and program, The existing requirements for LTC planning and testing process. They and the phrase ‘‘as defined by § 482.70’’. facilities contain specific requirements recommended that the method of • Modifying § 482.68(b) to exempt for emergency preparedness, set out at providing information from the transplant centers from the § 483.75(m)(1) and (2). Section emergency plan be clearly requirements in § 482.15. 483.75(m)(1) states that a facility must communicated with residents, • Removing the requirement in have detailed written plans and representatives, and caregivers and that § 482.78 for transplant centers to have procedures to meet all potential the LTC facilities follow a specific time agreements with another transplant emergencies and disasters, such as fire, frame to provide this communication. center. severe weather, and missing residents. Some commenters recommended that • Modifying the requirement in We proposed that this language be PACE facilities and HHAs be required to § 482.78(b) to require that a transplant incorporated into proposed include patients and their families in center be responsible for developing and § 483.73(a)(1). Existing § 483.75(m)(2) the emergency preparedness planning as maintaining mutually agreed upon states that a facility must train all well. protocols that address the duties and employees in emergency procedures A few commenters recommended that responsibilities of the transplant center, when they begin to work in the facility, LTC facilities include their state Long- hospital, and OPO during an emergency. periodically review the procedures with Term Care Ombudsman Program in this • Adding ‘‘as defined by § 482.70’’ existing staff, and carry out planning process. Some commenters that sets forth the definition of a unannounced staff drills using those also recommended that LTC facilities ‘‘transplant hospital’’ to clarify which procedures. These requirements would provide the Program with a completed hospitals are responsible for complying be incorporated into proposed emergency plan. with § 482.15(g). § 483.73(d)(1) and (2). Section Response: As we stated in the proposed rule, LTC facilities are unlike J. Emergency Preparedness 483.75(m)(1) and (2) would be removed. Our proposed emergency many of the inpatient care providers. Requirements for Long Term Care (LTC) preparedness requirements for LTC Many of the residents have long term or Facilities (§ 483.73) facilities are identical to those we extended stays in these facilities. Due to Section 1819(a) of the Act defines a proposed for hospitals at § 482.15, with the long term nature of their stays, these skilled nursing facility (SNF) for two exceptions. Specifically, at facilities essentially become the Medicare purposes as an institution or § 483.73(a)(1), we proposed that in an residents’ homes. We believe this fact a distinct part of an institution that is emergency situation, LTC facilities changes the nature of the relationship primarily engaged in providing skilled would have to account for missing with the residents and their families or nursing care and related services to residents. representatives. patients that require medical or nursing Section 483.73(c) would requires We continue to believe that each care or rehabilitation services due to an these facilities to develop an emergency facility should have the flexibility to injury, disability, or illness. Section preparedness communication plan, determine the information that is most 1919(a) of the Act defines a nursing which would include, among other appropriate to be shared with its facility (NF) for Medicaid purposes as things, a means of providing residents and their families or an institution or a distinct part of an information about the general condition representatives and the most efficient institution that is primarily engaged in and location of residents under the manner in which to share that providing to patients: skilled nursing facility’s care. We proposed to add an information. Therefore, we are finalizing care and related services for patients additional requirement at § 483.73(c)(8) our proposal at § 483.73(c)(8) that LTC who require medical or nursing care; that read, ‘‘A method for sharing facilities develop and maintain a rehabilitation services due to an injury, information from the emergency plan method for sharing information from the disability, or illness; or, on a regular that the facility has determined is emergency plan that the facility has basis, health-related care and services to appropriate with residents and their determined is appropriate with individuals who due to their mental or families or representatives.’’ residents and their families or physical condition require care and Also, we proposed at § 483.73(e)(1)(i) representatives. We note that we are not services (above the level of room and that LTC facilities must store emergency requiring that PACE and HHA providers board) that are available only through an fuel and associated equipment and share information from the emergency institution. systems as required by the 2000 edition plan with families and their To participate in the Medicare and of the Life Safety Code (LSC) of the representatives. However, these Medicaid programs, long-term care NFPA®. In addition to the emergency providers can choose to share (LTC) facilities must meet certain power system inspection and testing information with any appropriate party, requirements located at part 483, requirements found in NFPA® 99, so long as they comply with federal, Subpart B, Requirements for Long Term NFPA® 101, and NFPA® 110, we state, and local laws. Care Facilities. SNFs must be certified proposed that LTC facilities test their We are not requiring LTC facilities to as meeting the requirements of section emergency and stand-by-power systems share information with stakeholders, or 1819(a) through (d) of the Act. NFs must for a minimum of 4 continuous hours Long-Term Care Ombudsman Program be certified as meeting section 1919(a) every 12 months at 100 percent of the representatives, because we believe

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such a requirement could be overly Response: We agree with the options for transportation in planning burdensome for the LTC facilities. We commenter that transparency in for an evacuation. Another commenter believe that facilities need the flexibility communication is important. Therefore, recommended that there should be to develop their emergency plans and we are requiring that LTC facilities have coordination between vendors that determine what portions of those plans a method for sharing appropriate provide transportation services for LTC and the parties with whom those plans information with residents and their facility residents with other facilities should be shared. If a facility families or representatives. Consistent and community groups to avoid having determines that it is appropriate and with our belief that these emergency too many providers relying on a few timely to share either the complete preparedness requirements should vendors. emergency plan, or certain portions of afford facilities flexibility, we do not Response: We agree with the it, with stakeholders or representatives believe that it is appropriate to require commenters that it is preferable for from the Long-Term Care Ombudsman that LTC facilities take specific steps or facilities to have multiple options for Program, we encourage them to do so. utilize specific strategies to share these the provision of services, including Therefore, we are finalizing our documents with residents and their transportation, and that those services proposal at § 483.73(c)(2)(iii) that LTC families or representatives. be coordinated so that they are used facilities maintain the contact Comment: A commenter stated that efficiently. We also encourage facilities information for the Office of the State the communication plan requirement is to coordinate with other facilities in Long-Term Care Ombudsman. broad and will lead to inconsistent their geographic area to determine if Comment: A majority of commenters approaches for facilities. Furthermore, their arrangements with any service expressed support for the proposal that the commenter noted that this will provider are realistic. For example, if requires LTC facilities to develop a cause compliance and enforcement of two LTC facilities in the same city are communications plan. A few the rule to be subjective. depending upon the same transportation commenters also supported CMS’ Response: The proposed emergency vendor to evacuate their residents, both proposal to require LTC facilities to preparedness regulations provide the facilities should ensure that the vendor minimum requirements that facilities share information from the emergency has sufficient vehicles and personnel to must follow. This allows a variety of plan that the facility has determined is evacuate both facilities. Also, we believe facilities, ranging from small rural appropriate with residents and their that the requirements for testing that are providers to large facilities that are part families or representatives. A set forth in § 483.73(d)(2), especially the of a franchise or chain, the flexibility to commenter recommended that LTC full-scale exercise, should provide develop communication plans that are facilities follow a specific timeframe to facilities with the opportunity to test specific to the needs of their resident provide this communication. their emergency plans and determine if population and facility. Additionally, they need to include multiple options Response: We appreciate the we have written these regulations with for services and whether those services commenters’ support. We note that we the intention to allow for flexibility in have been coordinated. are not requiring specific timeframes for how facilities develop and maintain Comment: Due to the difficulty that LTC facility communications in these their emergency preparedness plans. the training requirement would place on emergency preparedness requirements. In addition to the CoPs/CfCs, smaller LTC facilities, a commenter We are allowing facilities the flexibility interpretative guidelines (IGs) will be suggested that we allow training by to make the determination on when developed for each provider and video demonstration, webinar, or by emergency preparedness plans and supplier types. We also note that association-sponsored programs where information should be communicated surveyors will be provided training on regional training can be given to the with the relevant entities during an the emergency preparedness staff of several facilities simultaneously. emergency or disaster. requirements, so that enforcement of the The commenter pointed out that group Comment: A commenter specifically rule will be based on the regulations set training would also bring about more in- recommended that CMS issue guidance forth here. depth discussion, questions, and to facilities regarding steps to Comment: A commenter noted that comments. disseminate information about the the proposed requirements for a Response: We agree that these training emergency plan to the general public. communication plan for LTC facilities styles could be beneficial. Our proposed These steps would include posting the do not mention a waiver that would requirement for emergency plan on the facility’s Web site, if allow for sharing of client information, preparedness training does not limit available, making a hard copy available which would create a potential violation training types to within the facility only. for review at the facility’s front desk; of HIPAA. Furthermore, the commenter Comment: CMS solicited comments providing a notice to residents upon requested clarification in the final rule. on whether LTC facilities should be entering a facility that they or their Response: As we stated previously in required to provide the necessary representative can receive a free this final rule, HIPAA requirements are electrical power to meet a resident’s electronic copy at any time by providing not suspended during a national or individualized power needs. Some their email address, and proving a copy public health emergency. Thus, the organizations recommended that the of the plan in electronic format to local communication plan is to be created regulation include specific requirements entities that are a resource for families consistent with the HIPAA Rules. See for a ‘‘resident’s power needs.’’ during a disaster. A commenter http://www.hhs.gov/ocr/privacy/hipaa/ However, many commenters were recommended that CMS require LTC understanding/special/emergency/ opposed to this requirement. Opposing facilities to make the plans available to hipaa-privacy. http://www.hhs.gov/ocr/ commenters stated that in an residents and their representatives upon privacy/hipaa/understanding/special/ emergency, based on the emergency and request. According to the commenter, emergency/hipaa-privacy-emergency- available resources, things such as information that the facility shares situations.pdf, for more information on medically sustaining life support should be written in clear and concise how HIPAA applies in emergency equipment would be needed rather than language and the facility’s Web site situations. a powered wheelchair and the could be a place for current, updated Comment: A commenter stated that individual facility would be best at information. LTC facilities should consider multiple making that determination. Some

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commenters recommended that the final operational control of some providers. could be confusing and that we should regulation state that power needs would However, we are not requiring LTC clarify that facilities should have plans be managed by the providers based on facilities to have onsite treatment of to account for missing residents in both priority to address critical equipment sewage or to be responsible for public emergency and non-emergency and systems both for individual needs services. LTC facilities would only be situations. as well as the needs of the entire required to make provisions for Response: We agree with the facility. maintaining the necessary services. commenter that LTC facilities must have Response: We appreciate the feedback Comment: A commenter noted that plans concerning missing residents that that we received from commenters on the proposed requirements do not can be activated regardless of whether this issue. We agree that the needs of the address the issue of regional evacuation. the facility must activate its emergency most vulnerable residents should be This commenter believed that this was plan. A missing resident is an considered first and expect that an essential part of an emergency plan emergency and LTC facilities must have facilities would take the needs of their and that the plan must address a plan to account for or locate the most vulnerable population into transportation and accommodations for missing resident. consideration as part of their daily people with physical, intellectual, or Comment: Some commenters wanted operations. At § 483.73(a)(3) we require cognitive impairments. The commenter more clarification on the requirements that the facility’s emergency plan also recommended that the regional for LTC facilities to have policies and address their resident population to evacuation plan account for long-term procedures that address subsistence include persons at-risk, the type of sheltering and that there be specific needs for staff and residents, services the facility has the ability to standards for sheltering-in-place. Also, particularly related to medical supplies provide in an emergency, and they believed that LTC facilities should and temperature to protect resident continuity of their operations. We agree be required to adopt the 2007 EP health and safety and for safe and with commenters, and want facilities to checklist that was issued by CMS. sanitary storage of provisions. A have the flexibility to conduct their risk Response: We agree with the commenter requested additional assessment, individually assess their commenter that the emergency plans for guidance and clarification on medical population, and determine in their LTC facilities should address regional as supplies. They questioned whether plans how they will meet the individual well as local evacuations and long-term ‘‘supplies’’ would include individual needs of their residents. We believe that as well as short-term sheltering-in-place. residents’ medications and, if it did, the individual power needs of the However, we are finalizing the how that affected prescribing limits, residents are encompassed within the requirement for the emergency plan to payment systems, access, etc. requirement that the facility assess its be based upon a facility-based and Furthermore, a commenter wanted resident population. Therefore, we are community-based risk assessment, clarification on power requirements for not adding a specific requirement for utilizing an all-hazards approach temperatures. Another commenter LTC facilities to provide the necessary (§ 483.73(a)(1)). The ‘‘all-hazards’’ recommended we specify a minimum power for a resident’s individualized approach includes emergencies that for all needed supplies and provisions. power needs. However, we encourage could affect only the facility as well as Response: We have not required facilities to establish policies and the community in which it is located minimums for these types of procedures in their emergency and beyond. It also includes requirements because they would vary preparedness plan that would address emergencies that are both short-term greatly between facilities. Each facility providing auxiliary electrical power to and long-term. When facilities are is required to conduct a facility-based power dependent residents during an developing their risk assessments, they and community-based assessment that emergency or evacuating such residents should be considering all of those addresses, among other things, its to alternate facilities. If a power outage possibilities. We disagree about the resident population. From that occurs during an emergency or disaster, recommendation that we propose more assessment, each facility should be able power dependent residents will require specific standards on sheltering-in- to identify what it needs for its resident continued electrical power for place. We believe that each facility population, including what medical/ ventilators, speech generator devices, needs the flexibility to develop its own pharmaceutical supplies it needs to dialysis machines, power mobility plans for sheltering-in-place for both maintain and its temperature needs for devices, certain types of durable short and long-term use. We also both its resident population and its medical equipment, and other types of disagree about requiring adoption of the necessary provisions. As to minimum equipment that are necessary for the 2007 CMS EP checklist, which can be time periods, each facility would need residents’ health and well-being. We found at https://www.cms.gov/ to determine those based on its therefore reiterate the importance of Medicare/Provider-Enrollment-and- assessment and any other applicable protecting the needs of this vulnerable Certification/SurveyCertEmergPrep/ requirements. population during an emergency. Downloads/SandC_EPChecklist_ Comment: A commenter Comment: A commenter objected to Persons_LTCFacilities_Ombudsmen.pdf. recommended that we require specific our proposal to require LTC facilities to That checklist is a resource that types of medical documentation in have policies and procedures that facilities may use. In addition, over time proposed § 483.73(b)(5). The commenter addressed alternate sources of energy to CMS may publish updates or other specifically recommended the inclusion maintain sewage and waste disposal. checklists or facilities may choose to use of resident demographics, allergies, The commenter indicated that the tools from other resources. diagnosis, list of medications and provision and restoration of sewage and Comment: A commenter agreed with contact information (commonly referred waste disposal systems may well be us that LTC facilities should have plans to as the ‘‘face sheet’’). beyond the operational control of some concerning missing residents. The Response: We appreciate the providers. current LTC requirements require LTC commenter’s suggestion. Proposed Response: We agree with the facilities have plan for emergencies, § 483.73(b)(5) required that the facility commenter that the provision and including missing residents have policies and procedures that restoration of sewage and waste disposal (§ 483.75(m)). However, the commenter address ‘‘A system of medical systems could be beyond the also believed that this requirement documentation that preserves resident

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information, protects confidentiality of demonstrate knowledge’’ with vary widely as well. However, we resident information, and ensures ‘‘Demonstrate staff knowledge.’’ believe each of them has the capability records are secure and readily • Revising § 483.73(d)(2)(i) by to comply fully with the requirements available.’’ While the types of replacing the term ‘‘community mock so that the health and safety of its documentation the commenter disaster drill’’ with ‘‘full-scale exercise.’’ clients are protected in the event of an identified will probably be included in • Revising § 483.73(d)(2)(ii) to allow a emergency situation or disaster. that documentation, we believe that LTC facility to choose the type of Thus, we proposed to require that facilities need the flexibility to exercise it will conduct to meet the ICF/IIDs meet the same requirements we determine what will be included in the second annual testing requirement. proposed for hospitals, with two • medical documentation and how they Revising § 483.73(e)(1) and (2) by exceptions. At § 483.475(a)(1), we will develop these systems. Thus, we removing the requirement for additional proposed that ICF/IIDs utilize an all- generator testing. hazards approach, including plans for are finalizing this provision as • proposed. Revising § 483.73(e)(2)(i) by locating missing clients. We believe that After consideration of the comments removing the requirement for an in the event of a natural or man-made we received on the proposals, and the additional 4 hours of generator testing disaster, ICF/IIDs would maintain general comments we received on the and by clarifying that LTC facilities responsibility for care of their own ® proposed rule, as discussed earlier in must meet the requirements of NFPA client population but would not receive ® the hospital section (section II.C. of this 99, 2012 edition and NFPA 110, 2010 patients from the community. Also, final rule), we are finalizing the edition. because we recognize that all ICF/IIDs • proposed emergency preparedness Revising § 483.73(e)(3) by removing clients have unique needs, we proposed requirements for LTC facilities with the the requirement that LTC facilities to require ICF/IIDs to ‘‘address the following modifications: maintain fuel quantities onsite and unique needs of its client population • Revising the introductory text of clarify that LTC facilities must have a . . .’’ at § 483.475(a)(3). § 483.73 by adding the term ‘‘local’’ to plan to maintain operations unless the In addressing the unique needs of clarify that LTC facilities must also LTC facility evacuates. their client population, we believe that • comply with local emergency Adding § 483.73(f) to allow a ICF/IIDs should consider their preparedness requirements. separately certified LTC facility within individual clients’ power needs. For • Revising § 483.73(a) to change the a healthcare system to elect to be a part example, some clients could have term ‘‘ensure’’ to ‘‘maintain.’’ of the healthcare system’s emergency motorized wheelchairs that they need • Revising § 483.73(b)(1)(i) to state preparedness program. for mobility, or require a continuous • that LTC facilities must have policies Adding a new § 483.73(g) to positive airway pressure or CPAP and procedures that address the need to incorporate by reference the machine, due to sleep apnea. We believe ® sustain pharmaceuticals during an requirements of 2012 NFPA 99, 2012 that the proposed requirements at ® ® emergency. NFPA 101, and 2010 NFPA 110. § 483.475(a) (a risk assessment utilizing • Revising § 483.73(b)(2) by clarifying K. Emergency Preparedness Regulations an all-hazards approach and that the that tracking during and after the for Intermediate Care Facilities for facility address the unique needs of its emergency applies to on-duty staff and Individuals With Intellectual Disabilities client population) encompass consideration of individual clients’ sheltered residents. We have also (ICF/IIDs) (§ 483.475) revised paragraph (b)(2) to provide that power needs and should be included in if on-duty staff and sheltered residents Section 1905(d) of the Act created the ICF/IIDs risk assessments and are relocated during the emergency, the ICF/IID benefit to fund ‘‘institutions’’ emergency plans. facility must document the specific with four or more beds to serve people As we stated earlier, the purpose of name and location of the receiving with [intellectual disability] or other this final rule is to establish facility or other location. related conditions. To qualify for requirements to ensure that Medicare • Revising § 483.73(b)(5) to replace Medicaid reimbursement, ICFs/IID must and Medicaid providers and suppliers the phrase ‘‘ensures records are secure be certified and comply with CoPs at 42 are prepared to protect the health and and readily available’’ to ‘‘secures and CFR part 483, subpart I, §§ 483.400 safety of patients in their care during maintains availability of records.’’ through 483.480. As of June 2016, there more widespread local, state, and • Revising § 483.73(b)(7) to replace were 6,237 ICFs/IID, serving national emergencies. We do not believe the term ‘‘ensure’’ with ‘‘maintain.’’ approximately 129,000 clients, and all the existing requirements for ICF/IIDs • Revising § 483.73(c) by adding the clients receiving ICF/IID services must are sufficiently comprehensive to term ‘‘local’’ to clarify that the LTC qualify financially for Medicaid protect clients during an emergency that facility must develop and maintain an assistance under their applicable state impacts the larger community. emergency preparedness plan. Clients with intellectual However, we have been careful not to communication plan that also complies disabilities who receive care provided remove emergency preparedness with local laws. by ICF/IIDs may have additional requirements that are more rigorous • Revising § 483.73(c)(5) to clarify emergency planning and preparedness than the additional requirements we that the LTC facility must develop a requirements. For example, some care proposed. means, in the event of an evacuation, to recipients are non-ambulatory, or may For example, our current regulations release patient information, as permitted experience additional mobility or for ICF/IIDs include requirements for under 45 CFR 164.510(b)(1)(ii). sensory disabilities or impairments, emergency preparedness. Specifically, • Revising § 483.73(d) by adding that seizure disorders, behavioral challenges, § 483.430(c)(2) and (3) contain specific each LTC facility’s training and testing or mental health challenges. requirements to ensure that direct care program must be based on the LTC Because ICF/IIDs vary widely in size givers are available at all times to facility’s emergency plan, risk and the services they provide, we expect respond to illness, injury, fire, and other assessment, policies and procedures, that the risk analyses, emergency plans, emergencies. However, we did not and communication plan. emergency policies and procedures, propose to relocate these existing • Revising § 483.73(d)(1)(iv) to emergency communication plans, and facility staffing requirements at replace the phrase ‘‘Ensure that staff can emergency preparedness training will § 483.430(c)(2) and (3) because they

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address staffing issues based on the ensure that all personnel on all shifts Comment: Multiple commenters number of clients per building and are familiar with the use of the facility’s expressed their opposition to the client behaviors, such as aggression. fire protection features; and evaluate the requirement for ICF/IIDs to hold Such requirements, while related to effectiveness of their emergency and evacuation drills at least quarterly for emergency preparedness tangentially, disaster plans and procedures. Currently each shift for personnel under varied are not within the scope of the § 483.470(i)(2) further specifies that conditions. Each commenter stated that emergency preparedness requirements facilities must evacuate clients during at quarterly evacuation drills are costly for ICF/IIDs. least one drill each year on each shift; and will require the unnecessary Current § 483.470, Physical make special provisions for the movement of clients which could result environment, includes a standard for evacuation of clients with physical in liability issues as well as disrupt emergency plan and procedures at disabilities; file a report and evaluation operations. § 483.470(h) and a standard for on each evacuation drill; and investigate Response: The requirement for evacuation drills at § 483.470(i). The all problems with evacuation drills, quarterly evacuation drills is one of the standard for emergency plan and including accidents, and take corrective requirements in the existing regulations procedures at current § 483.470(h)(1) action. Furthermore, during fire drills, for ICF/IIDs at § 483.470(i) (proposed to requires facilities to develop and facilities may evacuate clients to a safe be redesignated to § 483.470(h)). We implement detailed written plans and area in facilities certified under the stated in the proposed rule that the procedures to meet all potential Health Care Occupancies Chapter of the purpose of the rule was to establish emergencies and disasters, such as fire, Life Safety Code. Finally, at existing requirements to ensure that Medicare severe weather, and missing clients. § 483.470(i)(3), facilities must meet the and Medicaid providers and suppliers This requirement will be relocated to requirements of § 483.470(i)(1) and (2) are prepared to protect the health and proposed § 483.475(a)(1). Existing for any live-in and relief staff they safety of patients in their care during a § 483.470(h)(1) will be removed. utilize. Because these existing widespread emergency. While we did Currently § 483.470(h)(2) states, with requirements are so extensive, we not believe that the existing regard to a facility’s emergency plan, proposed cross referencing § 483.470(i) requirements for ICF/IIDs are that the facility must communicate, (redesignated as § 483.470(h)) at sufficiently comprehensive enough to periodically review the plan, make the proposed § 483.475(d). protect clients during an emergency that plan available, and provide training to Comment: A commenter impacts the larger community, we were the staff. These requirements are recommended that CMS include careful not to remove emergency covered in proposed § 483.475(d). language that would exclude preparedness requirements that are Current § 483.470(h)(2) will be removed. community-based residential services more rigorous than those additional ICF/IIDs are unlike many of the requirements we proposed. Therefore, inpatient care providers. Many of the servicing three or fewer residents. The commenter noted that implementing the we proposed to retain this requirement. clients can be expected to have long We believe that, unlike many of the same emergency preparedness term or extended stays in these inpatient care providers due to the long requirements as ICF/IID facilities for facilities. Due to the long term nature of term nature of their clients stays, ICF/ community based residential services their stays, these facilities essentially IIDs have a heightened responsibility to would be cost prohibitive. become the clients’ residences or ensure the safety of their clients given homes. Section 483.475(c) requires Response: A community-based that these facilities essentially become these facilities to develop an emergency residential facility with less than 4 beds the clients’ residences or homes. preparedness communication plan, would not meet the definition of an ICF/ Comment: A commenter expressed which includes, among other things, a IID and would not be covered under this their support for the emphasis that the means of providing information about regulation. We encourage facilities that proposed rule placed on drills and the general condition and location of are concerned about the implementation testing for this vulnerable population clients under the facility’s care. We did of emergency preparedness and pointed out that many accrediting not indicate what information from the requirements to refer to the various organizations require ICF/IIDs to test emergency plan should be shared or the resources noted in the proposed and their emergency management plans each timing or manner in which it should be final rules, and participate in healthcare year. disseminated. We believe that each coalitions within their community for Response: We thank the commenter facility should have the flexibility to support in implementing these for their support and agree that drills determine the information that is most requirements. and testing are an important aspect of appropriate to be shared with its clients Comment: A commenter agreed with developing a comprehensive emergency and their families or representatives and CMS’ proposal that ICF/IID providers’ preparedness program. the most efficient manner in which to communication plans be shared with Comment: A commenter stated that share that information. Therefore, we the families of their clients. The the proposed requirement to place a proposed to add an additional commenter noted that an annual generator in each home and to test it requirement at § 483.475(c)(8) that correspondence to families, with annually would be extremely costly. reads, ‘‘A method for sharing intermediate updates as changes or Response: We would like to clarify information from the emergency plan additions are made, should not be that we did not propose a requirement that the facility has determined is burdensome to facilities. for generators to be placed in each ICF/ appropriate with clients and their Response: We appreciate the IID facility. We proposed additional families or representatives.’’ commenter’s support. We have not set testing requirements for hospitals, The standard for disaster drills set specific requirements for when or how CAHs, and LTC facilities. However, due forth at existing § 483.470(i)(1) specifies often ICF/IID facilities should to the numbers of comments we that facilities must hold evacuation correspond with families and their received stating that the requirement for drills at least quarterly for each shift of representatives. However, facilities can additional testing would be overly personnel under varied conditions to choose to correspond with clients’ burdensome and unnecessary. We have ensure that all personnel on all shifts families and their representatives as removed this requirement in the final are trained to perform assigned tasks; frequently as they deem appropriate. rule.

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After consideration of the comments • Revising § 483.475(d)(2)(ii) to allow psychiatric condition and home we received on these provisions of the an ICF/IIDs to choose the type of environment. Such policies and proposed rule, and the general exercise it will conduct to meet the procedures must be in accord with the comments we received, as discussed in second annual testing requirement. HIPAA Privacy Rule, as appropriate. the hospital section (section II.C. of this • Adding § 483.475(e) to allow a We did not propose to require that final rule), we are finalizing the separately certified ICF/IID within a HHAs meet all of the same requirements proposed emergency preparedness healthcare system to elect to be a part that we proposed for hospitals. Since requirements for ICF/IIDs with the of the healthcare system’s emergency HHAs provide healthcare services only following modifications: preparedness program. in patients’ homes, we did not propose • requirements for policies and Revising the introductory text of L. Emergency Preparedness Regulations procedures to meet subsistence needs § 483.475, by adding the term ‘‘local’’ to for Home Health Agencies (HHAs) (§ 482.15(b)(1)); safe evacuation clarify that ICF/IIDs must also comply (§ 484.22) with local emergency preparedness (§ 482.15(b)(3)); or a means to shelter in requirements. Under the authority of sections place (§ 482.15(b)(4)). We would not • Revising § 483.475(a)(4) by deleting 1861(m), 1861(o), and 1891 of the Act, expect an HHA to be responsible for the term ‘‘ensuring’’ and replacing the the Secretary has established in sheltering HHA patients in their homes term ‘‘ensure’’ with ‘‘maintain.’’ regulations the requirements that a or sheltering staff at an HHA’s main or • Adding at § 483.475(b)(1)(i) that home health agency (HHA) must meet to branch offices. We did not propose to ICF/IIDs must have policies and participate in the Medicare program. require that HHAs comply with the procedures that address the need to Home health services are covered for proposed hospital requirement at sustain pharmaceuticals during an qualifying elderly and people with § 482.15(b)(8) regarding the provision of emergency. disabilities who are beneficiaries under care and treatment at alternate care sites • Revising § 483.47(b)(2) by clarifying the Hospital Insurance (Part A) and identified by the local health that tracking during and after the Supplemental Medical Insurance (Part department and emergency management emergency applies to on-duty staff and B) benefits of the Medicare program. officials. With respect to sheltered clients. We have also revised These services include skilled nursing communication, we did not propose paragraph (b)(2) to provide that if on- care, physical, occupational, and speech requirements for HHAs to have a means, duty staff and sheltered residents are therapy, medical social work and home in the event of an evacuation, to release relocated during the emergency, the health aide services which must be patient information as permitted under facility must document the specific furnished by, or under arrangement 45 CFR 164.510 as we propose for name and location of the receiving with, an HHA that participates in the hospitals at § 482.15(c)(5). We have also facility or other location. Medicare program and must be modified the proposed requirement for • Revising § 483.475(b)(5) to change provided in the beneficiary’s home. As hospitals at § 482.15(c)(7) by eliminating the phrase ‘‘ensures records are secure of June 2016, there were 12,335 HHAs the reference to providing information and readily available’’ to ‘‘secures and participating in the Medicare program. regarding the facility’s occupancy. The maintains availability of records;’’ also The majority of HHAs are for-profit, term occupancy usually refers to bed revising paragraph (b)(7) to change the privately owned agencies. There are no occupancy in an inpatient facility. term ‘‘ensure’’ to ‘‘maintain.’’ existing emergency preparedness Instead, at § 484.22(c)(6), we proposed • Revising § 483.475(b)(1), requirements in the HHA Medicare to require HHAs to provide information (b)(1)(ii)(A), and (b)(2) to replace the regulations at part 484, subparts B and about the HHA’s needs and its ability to term ‘‘residents’’ to ‘‘clients.’’ C. provide assistance to the local health Throughout the preamble discussion, We proposed to add emergency department authority having the terms ‘‘patients and residents’’ have preparedness requirements at § 484.22, jurisdiction or the Incident Command been deleted and replaced with the term under which HHAs would be required Center, or designee. ‘‘client.’’ to comply with some of the Comment: Several commenters stated • Revising § 483.475(c) by adding the requirements that we proposed for that, despite our efforts, our proposed term ‘‘local’’ to clarify that ICF/IIDs hospitals. We proposed additional requirements for HHAs were not must develop and maintain an requirements under the HHA policies tailored for organizations that provide emergency preparedness and procedures that would apply only home-based services. Commenters communication plan that also complies to HHAs to address the unique indicated that we did not provide a with local laws. circumstances under which HHAs complete description of our vision for • Revising § 483.475(c)(5) to clarify provide services. the role that HHAs would play during that ICF/IIDs must develop a means, in Specifically, we proposed at and emergency and requested more the event of an evacuation, to release § 484.22(b)(1) that an HHA have policies clarity. A commenter requested that we patient information, as permitted under and procedures that include plans for its work with the stakeholder community 45 CFR 164.510(b)(1)(ii). patients during a natural or man-made to develop a better understanding of • Revising § 483.475(d) by adding disaster. We proposed that the HHA how HHAs function, the needs of their that each ICF/IID’s training and testing include individual emergency patients, the communities in which they program must be based on the ICF/IID’s preparedness plans for each patient as deliver services, and their resources. emergency plan, risk assessment, part of the comprehensive patient Response: We appreciate the policies and procedures, and assessment at § 484.55. commenters’ feedback. Many patients communication plan. At § 484.22(b)(2), we proposed to depend on the services of HHAs • Revising § 483.475(d)(1)(iv) to require that an HHA to have policies nationwide and the effective delivery of replace the phrase ‘‘Ensure that staff can and procedures to inform federal, state quality home health services is essential demonstrate knowledge’’ to and local emergency preparedness to the care of illnesses and prevention ‘‘Demonstrate staff knowledge.’’ officials about HHA patients in need of of hospitalizations. It is imperative that • Revising § 483.475(d)(2)(i) by evacuation from their residences at any HHAs have processes in place to replacing the term ‘‘community mock time due to an emergency situation address the safety of patients and staff disaster drill’’ with ‘‘full-scale exercise.’’ based on the patient’s medical and and the continued provision of services

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in the event of a disaster or emergency. circumstances and requiring home possibility that they may need to We do not envision that HHAs will health nurses to prepare emergency provide self-care if agency personnel are perform roles outside of their plans for their patients falls outside the not available. For example, discussions capabilities during an emergency. In scope of their practice. Most of the to develop the individualized addition, some HHAs that have commenters supported the inclusion of emergency preparedness plans could agreements with hospitals already assist a requirement for home health patients include potential disasters that the hospitals when at surge capacity. Home to have a personal emergency plan, but patient may face within the home such care professionals also have first-hand noted that CMS should keep in mind as fire hazards, flooding, and tornados; experience working in non-structured that the individual plans are only a and how to contact local emergency care environments. This experience has starting place to locate and serve officials. Discussions may also include proven to be helpful in situations where patients and may not be applicable to education on steps that can be taken to patients are trapped in their homes or every type of emergency. A commenter increase the patient’s safety. The housed in shelters during a disaster or suggested that we not link the individualized plan would be the emergency. We also believe that because identification of the patients’ needs written answers and solutions as a HHAs provide home care, they have during an emergency to the patient result of these discussions and could be first-hand knowledge of medically assessment, but rather require that it as simple as a detailed emergency card compromised individuals who have the occur within the first two weeks after developed with the patient. As potential to be trapped in their homes the start of care to allow for staff to commenters have indicated that often and unable to seek safe shelter during ensure the patient’s acute care needs are time patients choose to negate their an emergency. This information is met and remain first priority. In plans and evacuate, we would expect invaluable to state and local emergency addition, some commenters that HHAs would use the individualized preparedness officials. All of these recommended that each HHA be emergency plan to instruct patients on activities and resources that HHAs have required to provide new patients and agency notification protocols for are necessary for effective community their families with a copy of the HHA’s patients that relocate during an emergency preparedness planning. emergency policy and to inform them of emergency and provide patients with We understand that one approach the requirement that each new patient information about the HHAs emergency may not work for some and that receive an individual emergency service procedures. HHAs could also use the community involvement will depend on plan. They also recommended providing individualized emergency plan to the specific needs and resources of the a copy of the HHA’s policies to the long- identify out of state contacts for each community. However, we believe that term care ombudsman programs that are patient if available. HHA personnel establishing these emergency involved in home healthcare. should document that these discussions preparedness requirements for HHAs, Response: We appreciate the occurred. We are not requiring that and the other provider and suppliers, comments that we received on this HHAs provide their emergency plan and encourages collaboration and issue. As a result of the comments, we policies to any long-term care coordination that allows for a agree that further clarification is needed. ombudsman programs, but we would consistent, yet flexible regulatory We also agree that all patients, their encourage cooperation between various framework across provider and supplier families and caregivers should be agencies. types. We would expect that HHAs will provided with information regarding the Comment: Several commenters stated be proactive in their role of HHA’s emergency plan and appropriate that HHAs and hospices have not been collaborating in community emergency contact information in the event of an included in community emergency preparedness planning efforts on both emergency. We did not intend for HHAs preparedness planning initiatives, nor the national and local level. Through to develop extensive emergency have they received additional these efforts we believe that preparedness plans with their patients. emergency planning funding. The stakeholders will gain the opportunities We proposed that HHAs include commenters therefore requested to educate and define their role in state individual emergency preparedness additional time and flexibility to and local emergency planning. plans for each patient as part of the comply with the requirements for a Comment: Many commenters from an comprehensive patient assessment communication plan. A few advocacy organization for HHAs agreed required at § 484.55. Specifically, commenters requested clarification on with the requirement that HHAs have current regulations at § 484.55 require what a communication plan for HHAs policies and procedures that include that each patient must receive, and an would entail. individual emergency preparedness HHA must provide, a patient-specific, Response: We understand the plans for each patient as part of the comprehensive assessment that commenters’ concerns about HHA comprehensive patient assessment. accurately reflects the patient’s current providers’ inclusion in community However, several commenters requested health status. In addition, regulations at emergency preparedness planning clarification regarding our proposal. § 484.55(a)(1) require that a registered initiatives. We believe that an Commenters indicated that often times, nurse must conduct an initial emergency preparedness plan will better during an emergency, a home care assessment visit to determine the prepare HHA providers in case of an patient or their family may make immediate care and support needs of emergency or disaster and help to different decisions and evacuate the the patient. As such, we believe that facilitate communication between patient, which largely negates any HHAs are already conducting and facilities and community emergency benefit from individualized plans. developing patient specific assessments preparedness agencies. Commenters stated that HHAs should be and during these assessments, we In response to the request for required to instead provide planning expect that it will be minimally additional time, we have set the materials to each patient upon burdensome for HHAs to instruct their implementation date of these assessment to assist them with staff to assess the patient’s needs in the requirements for 1 year following the developing a personal emergency plan. event of an emergency. effective date of this final rule to allow Some commenters indicated that We expect that HHAs already assist facilities time to prepare. We also refer patients should develop their own their patients with knowing what to do readers to the many resources that have emergency plans based on their unique in the event of an emergency and the been referenced in the proposed and

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final rules for guidance on developing ensure cooperation and collaboration of may choose volunteers through the an emergency preparedness various levels of government entities. federal ESAR–VHP program. However, communication plan for HHAs. HHAs The commenter noted that while it is we want to emphasis that the need and are also encouraged to collaborate and critical that HHAs seek inclusion in use of volunteers or both is left up to the participate in their local healthcare discussions and understand the discretion of each individual facility, coalition that will be able to help inform emergency planning efforts in their area, unless indicated as otherwise in their and enable them to better understand it has proven difficult for HHAs to individual regulations. how other providers are implementing secure inclusion. The commenter Comment: A commenter stated that the rules as well as provide access to requested that we eliminate the HHA and hospice providers should local health department and emergency requirement for HHAs to include a receive classification as essential management officials that participate in process for ensuring cooperation and healthcare personnel to gain access to local healthcare coalitions. collaboration with various levels of restricted areas, in order to integrate Comment: A few commenters government. into community-wide emergency expressed concern about the proposal to Response: We recognize that some communication systems. require that HHAs develop aspects of collaborating with various Response: We have no authority to arrangements with other HHAs and levels of government entities may be declare HHA and hospice providers as other providers to receive patients in the beyond the control of the HHA. In essential healthcare personnel in their event of limitations or cessation of general, we used the word ‘‘ensure’’ or local emergency management groups. operations to ensure the continuity of ‘‘ensuring’’ to convey that each provider We suggest that facilities who would services to HHA patients. Commenters and supplier will be held accountable like to gain access to restricted areas stated that it was unclear how a home- for complying with the requirements in discuss how they may obtain access to based patient is ‘‘received’’ by a similar this rule. However, to avoid any community-wide emergency entity. The commenters noted that ambiguity, we have removed the term communication systems with their state because most home health is provided ‘‘ensure’’ and ‘‘ensuring’’ from the and local government emergency in the home of the patient, care can be regulation text of all providers and preparedness agencies. suspended for a period of time. suppliers and have addressed the Comment: A commenter expressed Commenters also indicated that home requirements in a more direct manner. concern about the level of technology health patients are not transferred to Therefore, we are finalizing this required for HHAs and hospices to other HHAs. A commenter also stated proposal to require that HHAs include implement the emergency preparedness that home health patients should not be in their emergency plan a process for requirements. The commenter stated transferred to hospitals during an cooperation and collaboration with that this technology is expensive and emergency. A home health patient could local, tribal, regional, state, and federal not readily available. The commenter receive care at other care settings, emergency preparedness officials. As also noted that many HHA and hospice including those set up through proposed, we also indicate that HHAs providers provide services in rural areas emergency management and other state must include documentation of their where cell phone coverage is limited. and federal government agencies. The efforts to contact such officials and, The commenter also stated that it is commenters requested that CMS take when applicable, of its participation in dangerous for the staff of HHAs and these accommodations into collaborative and cooperative planning hospices located in urban areas to carry consideration when deciding whether to efforts. smart phone technology. The finalize this proposal. Comment: A few commenters commenter finally noted that few HHA Response: We agree with the requested further clarification in regards and hospice agencies provide staff with commenters. We understand that most to our use of the term ‘‘volunteers’’ as smart or satellite phones. HHAs would not necessarily transfer it relates to HHAs. Commenters noted Response: As we discussed previously patients to other HHAs during an that HHAs are not required to use in this final rule, we are not endorsing emergency and, based on this volunteers and that the role of a specific alternate communication understanding of the nature of HHAs, volunteers is not addressed at all in system nor are we requiring the use of we believe that HHAs should not be § 484.113. certain specific devices because of the required to establish arrangements with Response: We provided information associated burden and the potential other HHAs to transfer and receive on the use of volunteers in the proposed obsolescence of such devices. However, patients during an emergency. rule (78 FR 79097), specifically with we expect that facilities would consider Therefore, we are not finalizing the reference to the Medical Reserve Corps using alternate means to communicate proposed requirement at § 484.22(b)(6) and the ESAR–VHP programs. Private with staff and federal, state, tribal, and (c)(1)(iv). During an emergency, if a citizens or medical professionals not regional and local emergency patient requires care that is beyond the employed by a facility often offer their management agencies. Facilities can capabilities of the HHA, we would voluntary services to providers during choose to utilize the technology expect that care of the patient would be an emergency or disaster event. suggested in this rule or they can use rearranged or suspended for a period of Therefore, we believe that HHAs should other types of backup communication. time. However, we note that as required have policies and procedures in place to For example, if an HHA provider has at § 484.22(b)(2), HHAs will be address the use of volunteers in an nurses that work in a rural area without responsible to have procedures to emergency, among other emergency cell phone coverage, we would expect inform State and local emergency staffing strategies. We believe such that the HHA agency would have some preparedness officials about HHA policies should address, among other other means of communicating with the patients in need of evacuation from things, the process and role for nurse, should an emergency or disaster their residences at any time due to an integration of state or federally- occur. These means do not necessarily emergency situation, based on the designated healthcare professionals, in have to require sophisticated patient’s medical and psychiatric order to address surge needs during an technology, although the devices condition and home environment. emergency. As with previous discussed previously are proven useful Comment: A commenter indicated emergencies, facilities may choose to communication technology. HHA that it was unrealistic for HHAs to utilize assistance from the MRC or they providers are only required to provide,

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in their communication plan, plans for training in their emergency many other providers and suppliers primary and alternate means for preparedness procedures to all new and have shared similar concerns. Therefore, communicating with their staff and existing staff. We also stated that a HHA we have revised § 484.22 to provide that emergency management agencies. must ensure that staff can demonstrate HHAs may choose which type of Facilities are given the discretion to knowledge of their agency’s emergency training exercise they want to conduct choose what approach works for their procedures. The emergency in order to fulfill their second testing specific circumstance. preparedness plan should be more than requirement. In addition, we would Comment: In general, most a set of written instructions that is encourage agencies to continue looking commenters supported the proposed referred to in an emergency. Rather, it to their local county and state standards requiring a HHA to have should consist of policies and governments and local healthcare training and testing programs, but procedures that are incorporated into coalitions for opportunities to suggested some revisions. A commenter the facility’s daily operations so that it collaborate on their training and testing stated that we did not provide a direct is prepared to respond effectively efforts, such as a community full-scale link between the testing requirements during a disaster. Regular training and exercise. and the other requirements proposed for testing will ensure consistent staff After consideration of the comments HHAs. behavior during an emergency, and also we received on these proposals, and the Response: We thank the commenters help to identify and correct gaps in the general comments we received on the for their support of our proposed plan. In addition, we believe that proposed rule, as discussed in the training and testing requirements. We requiring annual training is consistent hospital section (section II.C. of this believe that the emergency plan and with the proposed requirement to final rule), we are finalizing the policies and procedures cannot be annually update a HHAs emergency proposed emergency preparedness executed without the proper training of plan and policies and procedures. We requirements for HHAs with the staff members to ensure they have an believe that it is best practice for following modifications: understanding of the procedures and facilities to ensure that their staff is • Revising the introductory text of testing to demonstrate its feasibility and regularly informed and educated in § 484.22 by adding the term ‘‘local’’ to effectiveness. order to be the most prepared during an clarify that HHAs must also comply Comment: We received a few emergency situation. with local emergency preparedness comments on our proposal to require Comment: A few commenters requirements. HHAs to provide annual training to expressed their concern in regard to our • Revising § 484.22(a)(4) by deleting their staff. A commenter stated that a proposal to require HHAs to participate the term ‘‘ensuring’’ and replacing the requirement for annual training in in a community mock disaster drill. The term ‘‘ensure’’ with ‘‘maintain.’’ emergency preparedness is an outdated commenters acknowledged the benefits • Revising § 484.22(b)(3) to require approach to ensuring the organization is and necessity of participating in drills that in the event that there is an ready to put its plan into effect should and exercises to determine the interruption in services during or due to the need arise. The commenter effectiveness of an agency’s plan, but an emergency, HHAs must have policies recommended that we revise the stated that conducting drills and in place for following up with patients requirement by emphasizing the need exercises is costly, time consuming, and to determine services that are still for HHAs to involve staff in testing and especially difficult for HHAs in remote needed. In addition, they must inform other activities that will reinforce areas. Taking into consideration all of State and local officials of any on-duty understanding of policies, procedures the documentation required for HHA staff or patients that they are unable to and their role in the implementation of patients, multiple commenters contact. the emergency plan. Another requested additional flexibility for • Revising § 484.22(b)(4) to change commenter stated that ongoing annual HHAs, indicating that requiring both an the phrase ‘‘ensures records are secure training is unnecessary and duplicative. annual tabletop exercise and a and readily available’’ to ‘‘secures and The commenter suggested that we community drill is outside of the maintains availability of records.’’ require only initial emergency capacity of many agencies, would • Removing § 484.22(b)(6) that preparedness training upon hire. Once disrupt and compromise patient care, required that HHAs develop this initial training is completed, copies and requested additional flexibility for arrangements with other HHAs and of the plans and procedures would be HHAs. A commenter suggested that other providers to receive patients in the kept on hand and readily accessible in HHAs be encouraged, rather than event of limitations or cessation of the event of an emergency. The required, to participate in a community operations to ensure the continuity of commenter stated that this approach disaster drill. Another commenter stated services to HHA patients. would ensure just as timely and that HHAs in particular would need to • Revising § 484.22(c) by adding the effective a response to an emergency as employ an additional person to be term ‘‘local’’ to clarify that the HHA annual education while requiring less responsible for exercise planning and must develop and maintain an training time of staff taking away from preparation and would also need to stop emergency preparedness patient care. providing patient care during the communication plan that also complies Response: We thank the commenters exercises. The commenter indicated that with local laws. for their comments and appreciate their there is a more cost effective and • Revising § 484.22(c)(1) to remove recommendations. The requirement for efficient way to ensure a HHA and its the requirement that HHAs include the annual training is a standard staff understand their emergency names and contact information for requirement of many Medicare CoPs. procedures without taking away from ‘‘Other HHAs’’ in the communication We believe that the requirement is not patient care and adding cost. The plan. outdated and is necessary to ensure that commenter suggested that, for HHAs, • Revising § 484.22(d) by adding that staff is regularly updated on their we should require ‘‘discussion-based’’ each HHA’s training and testing agency’s emergency preparedness exercises leading up to a community program must be based on the HHA’s procedures. In our proposed training mock drill required every 5 years. emergency plan, risk assessment, and testing standards, we stated that we Response: We appreciate the feedback policies and procedures, and would require a HHA to provide from these commenters. As discussed, communication plan.

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• Revising § 484.22(d)(1)(ii) by procedures for notifying community patients as permitted under 45 CFR replacing the phrase ‘‘Ensure that staff emergency personnel; (3) instructions 164.510(b)(4). can demonstrate knowledge’’ to regarding the location and use of alarm We proposed including in the CORF ‘‘Demonstrate staff knowledge.’’ systems and signals and firefighting emergency preparedness provisions a • Revising § 484.22(d)(2)(i) by equipment; and (4) specification of requirement for CORFs to have a replacing the term ‘‘community mock evacuation routes and procedures for method for sharing information and disaster drill’’ with ‘‘full-scale exercise.’’ leaving the facility. medical documentation for patients • Revising § 484.22(d)(2)(ii) to allow a Currently, § 485.64(b) requires each under the CORF’s care with other HHA to choose the type of exercise it CORF to: (1) Provide ongoing training healthcare facilities, as necessary, to will conduct to meet the second annual and drills for all personnel associated ensure continuity of care (see proposed testing requirement. § 485.68(c)(4)). At § 485.68(c)(5), we • with the CORF in all aspects of disaster Adding § 484.22(e) to allow a preparedness; and (2) orient and assign proposed to require CORFs to have a separately certified HHA within a specific responsibilities regarding the communication plan that include a healthcare system to elect to be a part facility’s disaster plan to all new means of providing information about of the healthcare system’s emergency personnel within 2 weeks of their first the CORF’s needs and its ability to preparedness program. workday. provide assistance to the local health M. Emergency Preparedness Regulations We proposed that CORFs comply with department or authority having for Comprehensive Outpatient the same requirements that would be jurisdiction or the Incident Command Rehabilitation Facilities (CORFs) required for hospitals, with appropriate Center, or designee. We did not propose (§ 485.68) exceptions. to require CORFs to provide information Specifically, at § 485.68(a)(5), we regarding their occupancy, as we Section 1861(cc) of the Act defines propose for hospitals, since the term the term ‘‘comprehensive outpatient proposed that CORFs develop and maintain the emergency preparedness occupancy usually refers to bed rehabilitation facility’’ (CORF) and lists occupancy in an inpatient facility. the requirements that a CORF must meet plan with assistance from fire, safety, and other appropriate experts. We did We proposed to remove § 485.64 and to be eligible for Medicare participation. incorporate certain requirements into By definition, a CORF is a non- not propose to require CORFs to provide basic subsistence needs for staff and § 485.68. This existing requirement at residential facility that is established § 485.64(b)(2) would be relocated to and operated exclusively for the patients as we proposed for hospitals at § 482.15(b)(1). Because CORFs are proposed § 485.68(d)(1). purpose of providing diagnostic, Currently, § 485.64 requires a CORF to outpatient facilities, we did not propose therapeutic, and restorative services to develop and maintain its disaster plan that CORFs have a system to track the outpatients for the rehabilitation of with assistance from fire, safety, and location of staff and patients under the injured, sick, and persons with other appropriate experts. We CORF’s care both during and after the disabilities, at a single fixed location, by incorporated this requirement at emergency as we propose to require for or under the supervision of a physician. proposed § 485.68(a)(5). Currently, hospitals at § 482.15(b)(2). At As of June 2016, there were 205 § 485.64(a)(3) requires that the training § 485.68(b)(1), we proposed to require Medicare-certified CORFs in the U.S. program include instruction in the that CORFs have policies and Section 1861(cc)(2)(J) of the Act also location and use of alarm systems and procedures for evacuation from the states that the CORF must meet other signals and firefighting equipment. We CORF, including staff responsibilities requirements that the Secretary finds incorporated these requirements at and needs of the patients. necessary in the interest of the health proposed § 485.68(d)(1). and safety of a CORF’s patients. Under We did not propose that CORFS have We did not receive any comments that this authority, the Secretary has arrangements with other CORFs or other specifically addressed the proposed rule established in regulations, at part 485, providers and suppliers to receive as it relates to CORFs. However, after subpart B, requirements that a CORF patients in the event of limitations or consideration of the general comments must meet to participate in the Medicare cessation of operations. Finally, we did we received on the proposed rule, as program. not propose to require CORFs to comply discussed in the hospital section Currently, § 485.64 ‘‘Conditions of with the proposed hospital requirement (section II.C. of this final rule, we are Participation: Disaster Procedures ’’ at § 482.15(b)(8) regarding alternate care finalizing the proposed emergency includes emergency preparedness sites identified by emergency preparedness requirements for CORFs requirements CORFs must meet. The management officials. with the following modifications: regulations state that the CORF must With respect to communication, we • Revising the introductory text of have written policies and procedures would not require CORFs to comply § 485.68, by adding the term ‘‘local’’ to that specifically define the handling of with a proposed requirement similar to clarify that CORFs must also comply patients, personnel, records, and the that for hospitals at § 482.15(c)(5) that with local emergency preparedness public during disasters. The regulation would require a hospital to have a requirements. requires that all personnel be means, in the event of an evacuation, to • Revising § 485.68(a)(4) by deleting knowledgeable with respect to these release patient information as permitted the term ‘‘ensuring’’ and replacing the procedures, be trained in their under 45 CFR 164.510, although we are term ‘‘ensure’’ with ‘‘maintain.’’ application, and be assigned specific clarifying in this final rule that CORFs • Revising § 485.68(b)(3) to replace responsibilities. must establish communications plans the phrase ‘‘ensures records are secure Currently, § 485.64(a) requires a CORF that are in compliance with federal and readily available’’ to ‘‘secures and to have a written disaster plan that is laws, including the HIPAA rules. In maintains availability of records.’’ developed and maintained with the addition, CORFs would not be required • Revising § 485.68(c), by adding the assistance of qualified fire, safety, and to comply with the proposed term ‘‘local’’ to clarify that the CORFs other appropriate experts. The other requirement at § 482.15(c)(6), which must develop and maintain an elements under § 485.64(a) require that would state that a hospital must have a emergency preparedness CORFs have: (1) Procedures for prompt means of providing information about communication plan that also complies transfer of casualties and records; (2) the general condition and location of with local laws.

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• Revising § 485.68(d) by adding that radio contact and available onsite emergency and stand-by-power systems each CORF’s training and testing within 30 minutes on a 24-hour basis or, for a minimum of 4 continuous hours program must be based on the CORF’s under certain circumstances for CAHs every 12 months at 100 percent of the emergency plan, risk assessment, that meet certain criteria, within 60 power load the CAH anticipates it will policies and procedures, and minutes. CAHs currently are required to require during an emergency. communication plan. coordinate with emergency response Comment: A few commenters stated • Revising § 485.68(d)(1)(iv) to systems in the area to establish that since CAHs play an important role replace the phrase ‘‘Ensure that staff can procedures under which a doctor of in rural communities, an immediate demonstrate knowledge’’ to medicine or osteopathy is immediately community response in the event of an ‘‘Demonstrate staff knowledge.’’ available by telephone or radio contact emergency is critical. • Revising § 485.68(d)(2)(i) by on a 24-hours a day basis to receive Response: We agree with the replacing the term ‘‘community mock emergency calls, provide information on commenters and we require CAHs, and disaster drill’’ with ‘‘full-scale exercise.’’ treatment of emergency patients, and • all providers, to comply with all Revising § 485.68(d)(2)(ii) to allow a refer patients to the CAH or other applicable federal, state, and local CORF to choose the type of exercise it appropriate locations for treatment. emergency preparedness requirements. will conduct to meet the second annual CAHs are required at existing We also encourage CAHs to participate testing requirement. § 485.623(c), ‘‘Standard: Emergency in state-wide collaborations where • Adding § 485.68(e) to allow a procedures,’’ to assure the safety of possible. separately certified CORF within a patients in non-medical emergencies by healthcare system to elect to be a part Comment: A couple of commenters training staff in handling emergencies, questioned the ability of CAHs to of the healthcare system’s emergency including prompt reporting of fires; preparedness program. participate in an integrated health extinguishing of fires; protection and, system to develop an emergency plan. N. Emergency Preparedness Regulations where necessary, evacuation of patients, They stated that providers and suppliers for Critical Access Hospitals (CAHs) personnel, and guests; and cooperation were encouraged throughout the (§ 485.625) with firefighting and disaster proposed rule to plan together and with authorities. CAHs must provide for their communities to achieve Sections 1820 and 1861(mm) of the emergency power and lighting in the coordinated responses to emergencies. Act provide that critical access hospitals emergency room and for battery lamps Response: As discussed previously in participating in Medicare and Medicaid and flashlights in other areas; provide this rule, we agree that CAHs should be meet certain specified requirements. We for fuel and water supply; and take able to participate in an in integrated have implemented these provisions in other appropriate measures that are health system to develop a universal 42 CFR part 485, subpart F, Conditions consistent with the particular of Participation for Critical Access conditions of the area in which the CAH plan that encompasses one community- Hospitals (CAHs). As of June 2016, there is located. Since CAHs are required to based risk assessment, separate facility- are 1,337 CAHs that must meet the CAH provide emergency services on a 24- based risk assessments, integrated CoPs and 121 CAHs with psychiatric or hour a day basis, they must keep policies and procedures that meet the rehabilitation distinct part units (DPUs). equipment, supplies, and medication requirements for each facility, and DPUs within CAHs must meet the used to treat emergency cases readily coordinated communication plans, hospital CoPs in order to receive available. training and testing. Currently, a CAH payment for services provided to We proposed to remove the current that is a member of a rural health Medicare or Medicaid patients in the standard at § 485.623(c) and relocate network has an agreement with at least DPU. these requirements into the appropriate one hospital in the network for patient CAHs are small, rural, limited-service sections of a new CoP entitled, referrals and transfers. The proposed facilities with low patient volume. The ‘‘Condition of Participation: Emergency requirement for a CAH’s emergency intent of designating facilities as Preparedness’’ at § 485.625, which preparedness communication plan ‘‘critical access hospitals’’ is to ensure would include the same requirements states that the CAH must include access to inpatient hospital services and that we propose for hospitals. contact information for other CAHs. outpatient services, including We proposed to relocate current However, to be consistent with an emergency services, that meet the needs § 485.623(c)(1) to proposed integrated approach, we have also of the community. § 485.625(d)(1). We proposed to changed the proposed requirements at If no patients are present, CAHs are incorporate current § 485.623(c)(2) into § 485.625(c)(1)(iv) to state that CAHs not required to have onsite clinical staff § 485.625(b)(1). Current § 485.623(c)(3) should develop a communication plan 24 hours a day. However, a doctor of would be included in proposed that would require them to have contact medicine or osteopathy, nurse § 485.625(b)(1). Current § 485.623(c)(4) information for other CAHs and practitioner, clinical nurse specialist, or would be reflected by the use of the hospitals or both. physician assistant is available to term ‘‘all-hazards’’ in proposed We also received a number of furnish patient care services at all times § 485.625(a)(1). Section 485.623(d) comments pertaining to the proposed the CAH operates. In addition, there would be redesignated as § 485.623(c). requirements for CAHs, most must be a registered nurse, licensed Also, as discussed in section II.A.4 of commenters addressing both hospitals practical nurse, or clinical nurse the of this final rule we proposed at and CAHs in their responses. Thus, we specialist on duty whenever the CAH § 485.625(e)(1)(i) that CAHs must store responded to the comments under the has one or more inpatients. In the event emergency fuel and associated hospital section (section II.C. of this of an emergency, existing requirements equipment and systems as required by final rule). After consideration of the state there must be a doctor of medicine the 2000 edition of the Life Safety Code comments we received on the proposed or osteopathy, a physician assistant, a (LSC) of the NFPA®. In addition to the rule, as discussed in section II.C of this nurse practitioner, or a clinical nurse emergency power system inspection and final rule, we are finalizing the specialist, with training or experience in testing requirements found in NFPA® 99 proposed emergency preparedness emergency care, on call and and NFPA® 110 and NFPA® 101, we requirements for CAHs with the immediately available by telephone or proposed that CAHs test their following:

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• Revising the introductory text of and clarify that these facilities must outpatient physical therapy and speech- § 485.625 by adding the term ‘‘local’’ to meet the requirements of NFPA® 99 language pathology services. In the clarify that CAHs must also comply 2012 edition, NFPA® 101 2012 edition, remainder of this proposed rule and with local emergency preparedness and NFPA® 110, 2010 edition. throughout the requirements, we use the requirements. • Revising § 485.625(e)(3) by term ‘‘Organizations’’ instead of • Revising § 485.625(a)(4) by deleting removing the requirement that CAHs ‘‘clinics, rehabilitation agencies, and the term ‘‘ensuring’’ and replacing the maintain fuel onsite and clarify that public health agencies as providers of term ‘‘ensure with ‘‘maintain.’’ CAHs must have a plan to maintain outpatient physical therapy and speech- • Adding at § 485.625(b)(1)(i) that operations unless the CAH evacuates. language pathology services’’ for CAHs must have policies and • Adding § 485.625(f) to allow a consistency with current regulatory procedures that address the need to separately certified CAH within a language. sustain pharmaceuticals during an healthcare system to elect to be a part We believe these Organizations emergency. of the healthcare system’s emergency comply with a provision similar to our • Revising § 485.625(b)(2) to remove preparedness program. proposed requirement for hospitals at the requirement for CAHs to track on- • Adding § 485.625(g) to incorporate § 482.15(c)(7), which states that a duty staff and patients after an by reference the requirements of 2012 communication plan must include a ® ® emergency and clarifying that in the NFPA 99, 2012 NFPA 101, and 2010 means of providing information about ® event staff and patients are relocated, NFPA 110. the hospital’s occupancy, needs, and its the CAH must document the specific O. Emergency Preparedness Regulation ability to provide assistance, to the local name and location of the receiving for Clinics, Rehabilitation Agencies, and health department and emergency facility or other location to which on- Public Health Agencies as Providers of management authority having duty staff and patients were relocated to Outpatient Physical Therapy and jurisdiction, or the Incident Command during an emergency. Center, or designee. At § 485.727(c)(5), • Speech-Language Pathology Services Revising § 485.625(b)(5) to change (§ 485.727) we proposed to require that these the phrase ‘‘ensures records are secure Organizations have a communication and readily available’’ to ‘‘secures and Under the authority of section 1861(p) plan that include a means of providing maintains availability of records;’’ also of the Act, the Secretary has established information about their needs and their revising paragraph (b)(7) to change the CoPs that clinics, rehabilitation ability to provide assistance to the term ‘‘ensure’’ to ‘‘maintain’’ agencies, and public health agencies authority having jurisdiction (local and • Revising § 485.625(c) by adding the must meet when they provide state agencies) or the Incident Command term ‘‘local’’ to clarify that the CAHs outpatient physical therapy (OPT) and Center, or designee. We did not propose must develop and maintain an speech-language pathology (SLP) to require these Organizations to emergency preparedness services. The CoPs are set forth at part provide information regarding their communication plan that also complies 485, subpart H. occupancy, as we proposed for with local laws. Section 1861(p) of the Act describes hospitals, since the term ‘‘occupancy’’ • Revising § 485.625(c)(1)(iv) by ‘‘outpatient physical therapy services’’ usually refers to bed occupancy in an adding the phrase ‘‘and hospitals’’ to to mean physical therapy services inpatient facility. clarify that a CAH’s communication furnished by a provider of services, a The current regulations at § 485.727, plan must include contact information clinic, rehabilitation agency, or a public ‘‘Disaster preparedness,’’ require these for other CAHs and hospitals in the health agency, or by others under an Organizations to have a disaster plan. area. arrangement with, and under the The plan must be periodically • Revising § 485.625(c)(5) to clarify supervision of, such provider, clinic, rehearsed, with procedures to be that CAHs must develop a means, in the rehabilitation agency, or public health followed in the event of an internal or event of an evacuation, to release agency to an individual as an external disaster and for the care of patient information, as permitted under outpatient. The patient must be under casualties (patients and personnel) 45 CFR 164.510(b)(1)(ii). the care of a physician. arising from a disaster. Additionally, • Revising § 485.625(d) by adding The term ‘‘outpatient physical therapy current § 485.727(a) requires that the that each CAH’s training and testing services’’ also includes physical therapy facility have a plan in operation with program must be based on the CAH’s services furnished to an individual by a procedures to be followed in the event emergency plan, risk assessment, physical therapist (in the physical of fire, explosion, or other disaster. policies and procedures, and therapist’s office or the patient’s home) Those requirements are addressed communication plan. who meets licensing and other throughout the proposed CoP, and we • Revising § 485.625(d)(1)(iv) to standards prescribed by the Secretary in did not propose including the specific replace the phrase ‘‘ensure that staff can regulations, other than under language in our proposed rule. demonstrate knowledge’’ to arrangement with and under the However, existing § 485.727(a) also ‘‘demonstrate staff knowledge.’’ supervision of a provider of services, requires that the plan be developed and • Revising § 485.625(d)(2)(i) by clinic, rehabilitation agency, or public maintained with the assistance of replacing the term ‘‘community mock health agency, if the furnishing of such qualified fire, safety, and other disaster drill’’ with ‘‘full-scale exercise.’’ services meets such conditions relating appropriate experts. Because this • Revising § 485.625(d)(2)(ii) to allow to health and safety as the Secretary existing requirement is specific to a CAH to choose the type of exercise it may find necessary. The term also existing disaster preparedness will conduct to meet the second annual includes SLP services furnished by a requirements for these organizations, we testing requirement. provider of services, a clinic, relocated the language to proposed • Revising § 485.625(e)(1) and (2) by rehabilitation agency, or by a public § 485.727(a)(6). removing the requirement for additional health agency, or by others under an Existing requirements at § 485.727(a) generator testing. arrangement. also state that the disaster plan must • Revising § 485.625(e)(2)(i) by As of June 2016, there are 2,135 include: (1) Transfer of casualties and removing the requirement for an clinics, rehabilitation agencies, and records; (2) the location and use of additional 4 hours of generator testing public health agencies that provide alarm systems and signals; (3) methods

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of containing fire; (4) notification of assessment, policies and procedures, • Revising the introductory text of appropriate persons, and (5) evacuation and communication plan. § 485.920 by adding the term ‘‘local’’ to routes and procedures. Because transfer • Revising § 485.727(d)(1)(iv) to clarify that CMHCs must also comply of casualties and records, notification of replace the phrase ‘‘ensure that staff can with local emergency preparedness appropriate persons, and evacuation demonstrate knowledge’’ to requirements. routes are addressed under policies and ‘‘demonstrate staff knowledge.’’ • Revising § 485.920(a)(4) by deleting procedures in our proposed language, • Revising § 485.727(d)(2)(i) by the term ‘‘ensuring’’ and replacing the we do not propose to relocate these replacing the term ‘‘community mock term ‘‘ensure’’ with ‘‘maintain.’’ • requirements. However, because the disaster drill’’ with ‘‘full-scale exercise.’’ Revising § 485.920(b)(1) by requirements for location and use of • Revising § 485.727(d)(2)(ii) to allow clarifying that tracking during and after alarm systems and signals and methods an Organization to choose the type of the emergency applies to on-duty staff of containing fire are specific for these exercise it will conduct to meet the and sheltered clients. We have also organizations, we proposed to relocate second annual testing requirement. revised paragraph (b)(1) to provide that these requirements to § 485.727(a)(4). • Adding § 485.727(e) to allow a if on-duty staff and sheltered clients are Currently, § 485.727(b) specifies separately certified Organizations relocated during the emergency, the requirements for staff training and within a healthcare system to elect to be facility must document the specific drills. This requirement states that all a part of the healthcare system’s name and location of the receiving employees must be trained, as part of facility or other location. emergency preparedness program. • their employment orientation, in all Revising § 485.920(b)(4) and (6) to aspects of preparedness for any disaster. P. Emergency Preparedness Regulations change the phrase ‘‘ensures records are This disaster program must include for Community Mental Health Centers secure and readily available’’ to orientation and ongoing training and (CMHCs) (§ 485.920) ‘‘secures and maintains availability of drills for all personnel in all procedures A community mental health center records.’’ Also, we made changes in so that each employee promptly and (CMHC), as defined in section paragraph (b)(6) to replace the term ‘‘ensure’’ to ‘‘maintain.’’ correctly carries out his or her assigned 1861(ff)(3)(B) of the Act, is an entity that • role in case of a disaster. Because these meets applicable licensing or Revising § 485.920(c) by adding the requirements are addressed in proposed certification requirements in the state in term ‘‘local’’ to clarify that CMHCs must § 485.727(d), we did not propose to which it is located and provides the set develop and maintain an emergency relocate them but merely to address of services specified in section preparedness communication plan that them in that paragraph. Current 1913(c)(1) of the Public Health Service also complies with local laws. • Revising § 485.920(c)(5) to clarify § 485.727, ‘‘Disaster preparedness,’’ Act. Section 4162 of Public Law 101– that CMHCs must develop a means, in would be removed. 508 (OBRA 1990), which amended the event of an evacuation, to release We did not receive any comments that section 1861(ff)(3)(A) and 1832(a)(2)(J) patient information, as permitted under specifically addressed the proposed rule of the Act, includes CMHCs as entities 45 CFR 164.510(b)(1)(ii). as it relates to clinics, rehabilitation that are authorized to provide partial • Revising § 485.920(d) by adding agencies, and public health agencies as hospitalization services under Part B of that each CMHC’s training and testing providers of outpatient physical therapy the Medicare program, effective for program must be based on the CMHC’s and speech-language pathology services. services provided on or after October 1, emergency plan, risk assessment, However, after consideration of the 1991. Section 1866(e)(2) of the Act and policies and procedures, and general comments we received on the 42 CFR 489.2(c)(2) recognize CMHCs as communication plan. proposed rule, as discussed in the providers of services for purposes of • Revising § 485.920(d)(1) to replace hospital section (section II.C. of this provider agreement requirements but the phrase ‘‘ensure that staff can final rule, we are finalizing the only with respect to providing partial demonstrate knowledge’’ to proposed emergency preparedness hospitalization services. In 2015 there ‘‘demonstrate staff knowledge.’’ requirements for these Organizations were 362 Medicare-certified CMHCs. • Revising § 485.920(d)(2)(i) by with the following modifications: We proposed that CMHCs meet the • replacing the term ‘‘community mock Revising the introductory text of same emergency preparedness disaster drill’’ with ‘‘full-scale exercise.’’ § 485.727 by adding the term ‘‘local’’ to requirements we proposed for hospitals, • Revising § 485.920(d)(2)(ii) to allow clarify that the Organizations must also with a few exceptions. At a CMHC to choose the type of exercise comply with local emergency § 485.920(c)(7), we proposed to require it will conduct to meet the second preparedness requirements. CMHCs to have a communication plan annual testing requirement. • Revising § 485.727(a)(5) by deleting that include a means of providing • Adding § 485.920(e) to allow a the term ‘‘ensuring’’ and replacing the information about the CMHCs’ needs separately certified CMHC within a term ‘‘ensure’’ with ‘‘maintain.’’ and their ability to provide assistance to healthcare system to elect to be a part • Revising § 485.727(b)(3) to change the local health department or of the healthcare systems emergency the phrase ‘‘ensures records are secure emergency management authority preparedness program. and readily available’’ to ‘‘secures and having jurisdiction or the Incident maintains availability of records.’’ Command Center, or designee. Q. Emergency Preparedness Regulations • Revising § 485.727(c), by adding the We did not receive any comments that for Organ Procurement Organizations term ‘‘local’’ to clarify that the specifically addressed the proposed rule (OPOs) (§ 486.360) Organizations must develop and as it relates to CMHCs. However, after Section 1138(b) of the Act and 42 CFR maintain an emergency preparedness consideration of the general comments part 486, subpart G, establish that OPOs communication plan that also complies we received on the proposed rule, as must be certified by the Secretary as with local laws. discussed in the hospital section meeting the requirements to be an OPO • Revising § 485.727(d) by adding (section II.C. of this final rule), we are and designated by the Secretary for a that the Organization’s training and finalizing the proposed emergency specific donation service area (DSA). testing program must be based on the preparedness requirements for CMHCs The current OPO CfCs do not contain organization’s emergency plan, risk with the following modifications: any emergency preparedness

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requirements. As of June 2016, there under § 486.344(d), the duties and regional, and local emergency were 58 Medicare-certified OPOs that responsibilities of the hospital, preparedness staff. Facilities can choose are responsible for identifying potential transplant program, and the OPO in the to include the contact information of organ donors in hospitals, assessing event of an emergency. other entities in their communication their suitability for donation, obtaining Comment: We proposed the OPOs plan; however, we are not narrowing the consent from next-of-kin, managing should track their staff during and after scope of our requirements in this potential donors to maintain organ an emergency. All of the comments we section to only include those entities viability, coordinating recovery of received regarding this requirement with which an OPO has an arrangement. organs, and arranging for transport of were supportive. Commenters requested We continue to believe that it is organs to transplant centers. Our that we clarify whether an electronic important that OPOs have contact proposed requirements for OPOs to system will satisfy this requirement. information for all of the previously develop and maintain an emergency Commenters indicated that many OPOs specified entities because the OPO preparedness plan, were similar to those currently have a means to communicate cannot know before an emergency what proposed for hospitals, with some with all staff electronically and request entities or services it would need. Also, exceptions. that they respond with their location we do not believe that it is burdensome Since potential donors are located (within an identified time period) if for OPOs to maintain contact within hospitals, at proposed necessary. Commenters questioned information for these entities because § 486.360(a)(3), instead of addressing whether this process would be sufficient we believe that maintenance of contact the patient population as proposed for to meet this requirement. information for these various entities is hospitals at § 482.15(a)(3), we proposed Response: We appreciate the part of the normal course of business. that the OPO address the type of commenters’ feedback and agree that the Comment: Several commenters hospitals with which the OPO has means of communication described by requested clarification on whether agreements; the type of services the commenters is sufficient to meet this existing databases of contact OPO has the capacity to provide in an requirement. However, we want to information would satisfy the emergency; and continuity of emphasize that this is not the only way communication plan requirements. The operations, including delegations of OPOs may choose to meet this commenters listed examples such as a authority and succession plans. requirement. In the proposed rule, we hosted volunteer tracking system or We proposed only 2 requirements for indicated that OPOs have the flexibility UNOS’ DonorNET, with external OPOs at § 486.360(b): (1) A system to to determine how best to track staff backups. track the location of staff during and whether an electronic database, hard Response: Each OPO should develop after an emergency; and (2) a system of copy documentation, or some other and maintain its own separate contact medical documentation that preserves method. list in order to satisfy the potential and actual donor information, Comment: A few commenters agreed communication plan requirements. protects confidentiality of potential and with the proposal that would require OPOs must include contact information actual donor information, and ensures that communication plans include for staff, entities providing services records are secure and readily available. names and contact information for staff, under arrangement, volunteers, other In addition, at § 486.360(c), we entities providing services under OPOs, transplant and donor hospitals in proposed only three requirements for an arrangement, volunteers, other OPOs, the OPO’s DSA and federal, state, tribal, OPO’s communication plan. An OPO’s and transplant and donor hospitals in regional, and local emergency communication plan would be required the OPO’s DSA. However, the preparedness staff, and other sources of to include: (1) Names and contact commenters requested that CMS narrow assistance. DonorNET and other hosted information for staff; entities providing the requirements for OPOs to include volunteer tracking systems may contain services under arrangement; volunteers; only individuals or entities providing useful contact information that OPO other OPOs; and transplant and donor services under arrangement to those providers can use during an emergency, hospitals in the OPO’s DSA; (2) contact entities that would provide services in but these systems do not replace the information for federal, state, tribal, or during an emergency situation, such need for comprehensive contact lists in regional, or local health department and as emergency contacts for building the provider’s emergency preparedness emergency preparedness staff and other services (plumbing, electrical, etc.), communication plan. sources of assistance; and (3) primary transportation providers, laboratory Comment: In regard to our proposed and alternate means for communicating testing, etc. requirements for OPOs to have training with the OPO’s staff, federal, state, Another commenter also agreed with and testing programs, all the tribal, regional, or local emergency the importance of providing a commenters agreed with our proposals, management agencies. Unlike the communication plan with staff but requested clarification of the phrase requirement we proposed for hospitals information, but disagreed with the ‘‘consistent with their expected roles.’’ at § 482.15(d)(2)(i) and (iii), we requirement that all entities providing The commenters questioned whether proposed at § 486.360(d)(2)(i) that an services under arrangement with an this meant that an OPO is not required OPO be required only to conduct a OPO should be contacted during an to perform emergency preparedness tabletop exercise. emergency. The commenter training to staff, vendors, and volunteers Finally, at § 486.360(e), we proposed recommended that only vendors who are not expected to play a role in that each OPO have agreement(s) with providing critical services be contacted. the OPOs emergency response. one or more other OPOs to provide Response: We are requiring that OPOs Response: This final rule requires that essential organ procurement services to provide in their communication plan all persons (those employed, contracted, all or a portion of the OPO’s DSA in the the names and contact information for or volunteering) who provide some event that the OPO cannot provide such staff, entities providing services under service within an OPO must be trained services due to an emergency. We also arrangement, volunteers, other OPOs, on the OPOs emergency preparedness proposed that the OPO include within and transplant and donor hospitals in procedures, given that an emergency its agreements with hospitals required the OPO’s DSA. We are also requiring can take place at any time. All providers under § 486.322(a) and in the protocols that OPOs include the contact and suppliers types have the flexibility with transplant programs required information for federal, state, tribal, to determine the level of training that is

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need for each staff person. As the will vary depending upon many factors. we had considered this as an alternative requirement states for OPOs, this level The number of hospitals the OPO works to the proposed agreement. of training should be determined with, the services that each hospital Response: We did not propose having consistent with the persons expected offers, and the geographical hazards for multiple locations as an alternative to role during an emergency. It does not each of these hospitals are all factors the proposed requirement to have an eliminate the need for all persons to be that could affect how complex the agreement with another OPO. However, trained; however, an OPO has the emergency plan and program would as the commenters suggested, we do discretion to determine to what extent. need to be. And, all of these various believe that having more than one Comment: Most of the commenters factors would need to be addressed in location could certainly satisfy our did not agree with the proposed the OPO’s emergency plan. We realize concern that OPOs have the capability requirement that each OPO have an developing emergency plans and to continue their organ procurement agreement with one or more other programs can be challenging; however, responsibilities in the event of an OPOs. These commenters stated that the since OPOs are already working with emergency. Therefore, in finalizing this requirement was unnecessary and too these hospitals and there are a wide- requirement, we have added two burdensome. They indicated that our range of emergency planning tools alternatives to the requirement for an estimate of 13 burden hours was available, as well as assistance from the OPO to have an agreement with another extremely conservative and that OPTN and other organizations, we OPO (§ 486.360(e)). For OPOs with possibly as many as 200 contracts believe that OPOs will be able to multiple locations, the OPO could would need to be modified to comply develop their emergency preparedness satisfy this requirement if it had an with the requirements in proposed plans and programs within the burden alternate location within its DSA from § 486.360(e). estimates we have developed. which it could continue its operation Response: We agree with the Comment: As discussed earlier with during an emergency. Another commenters. The majority of the transplant centers, several commenters alternative is if the OPO had a plan to commenters indicated that complying expressed concerned about how the relocate to an alternate location that is with this requirement would require proposed OPO requirements could part of its emergency plan as required in much more than the estimated 13 interfere with or even contradict OPTN § 486.360(a). If the emergency were to burden hours. In reviewing their policies on emergencies; the commenter affect an area larger than the OPO’s comments and our estimate, we believe specifically referenced OPTN 1.4 that DSA, we would expect that the OPTN that the requirement for an agreement addresses regional and national would assist the OPO (OPTN Policy with one or more OPOs should be emergencies. Among other things, this 4.1). modified. Based upon our analysis and policy requires OPTN members to notify Comment: Some commenters comments submitted in response to the the OPTN concerning any alternative suggested that instead of having formal proposed rule, we have inserted arrangements of care during an agreements, OPOs, transplant centers, alternate ways in which an OPO could emergency and provide additional and hospitals should be required to plan to continue its operations. See information as needed to allow for develop mutually agreed-upon protocols § 486.360(e). See section III.O. of this clinical information to be properly that address each facility’s final rule Collection of Information accessed and shared with all parties responsibilities during an emergency. Requirements, ICRs Regarding involved in a donation or transplant Response: We agree with the Condition for Coverage: Emergency event. commenters. After reviewing the Preparedness (§ 486.360), for our current Response: We disagree with the comments we received on the proposed burden estimate. commenters. We do not expect any OPO transplant center and OPO emergency We disagree with the commenters that to violate any of the OPTN’s policies. preparedness requirements, we believe the requirement for OPOs to have an However, as stated earlier, the OPTN’s that the best way to ensure that agreement with another OPO is policies are not comprehensive. For transplant centers, the hospitals in unnecessary. We believe each OPO example, they do not cover local which they operate, and the OPOs are should be prepared to continue its emergencies or the other specific prepared for emergencies is to require operations or at least those activities it requirement in this final rule, that is, the development of mutually agreed- deems essential during an emergency as requirements for a risk assessment using upon protocols that address the required by § 486.360(e). However, as an all-hazards approach, an emergency hospital, transplant center, and OPO’s discussed later in this final rule, based plan, specific policies and procedures, a duties and responsibilities during an on the comments we received, we have communication plan, and training and emergency. Therefore, we have removed decided to provide alternate ways in testing. In addition, as described earlier, the requirements in proposed which OPOs could satisfy this including emergency preparedness § 482.78(a), which required an requirement, which are discussed as requirements in the OPO CfCs provides agreement with at least one Medicare- follows: us with oversight and enforcement approved transplant center, and Comment: A commenter noted the authority we do not have for the OPTN § 482.78(b), which required that the difficulty in developing an emergency policies. In addition, we do not believe transplant center ensure that the written plan based upon the all-hazards that complying with any of the agreement required under § 482.100 approach. One OPO works with more requirements in this final rule will addresses the duties and responsibilities than 170 hospitals. Each hospital had its result in any conflict with the OPTN’s of the hospital and OPO during an own specific levels of service and donor requirements. emergency. Instead, we have finalized a potential. These hospitals also had Comment: Some commenters requirement at § 486.360(e) that OPOs different geographically-based hazards. questioned whether OPOs that already develop mutually-agreed upon protocols All of these factors would need to be had more than one location or office that address the duties and addressed or taken into account when needed to have an agreement with responsibilities of the hospital, developing an emergency program. another OPO to provide essential organ transplant center, and OPO during Response: The amount of resources procurement services to all or a portion emergencies. We are also requiring that that each OPO must expend to comply of their DSA in the event of an transplant centers and the hospitals in with the requirements in this final rule emergency. A commenter questioned if which they operate develop mutually-

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agreed upon protocols. Therefore, all 3 • Revising § 486.360(c) by adding the At § 491.6(c)(2), the RHC or FQHC must facilities will need to work together to term ‘‘local’’ to clarify that the OPO place exit signs in appropriate locations. develop and maintain protocols that must develop and maintain an This requirement would be incorporated address emergency preparedness. emergency preparedness into our proposed requirement at Comment: A commenter communication plan that also complies § 491.12(b)(1), which would require recommended that CMS revise language with local laws. RHCs and FQHCs to have policies and in the manual to cover the costs of • Revising § 486.360(d) by adding procedures for safe evacuation from the transportation of brain-dead donors for that each OPO’s training and testing facility which includes appropriate organ procurement. Furthermore, the program must be based on the OPO’s placement of exit signs. Finally, at commenter recommended that emergency plan, risk assessment using § 491.6(c)(3), the RHC or FQHC must transplant centers be permitted to an all hazards approach, policies and take other appropriate measures that are record organs from brain-dead donors procedures, and communication plan. consistent with the particular sent to OPO recovery centers in the ratio • Revising § 486.360(d)(1)(iv) to conditions of the area in which the of Medicare usable organs to total replace the phrase ‘‘ensure that staff can facility is located. This requirement organs on their costs reports. The demonstrate knowledge’’ to would be addressed throughout the commenter noted that this would ‘‘demonstrate staff knowledge.’’ proposed CfC for RHCs and FQHCs, • facilitate implementation of the Revising the requirement in particularly proposed § 491.12(a)(1), proposed emergency preparedness § 486.360(e) to require the development which requires the RHCs and FQHCs to requirements. and maintenance of emergency perform a risk assessment based on an Response: We believe it is extremely preparedness protocols that are ‘‘all-hazards’’ approach. Current unlikely that brain-dead donors would mutually agreed upon by the transplant § 491.6(c) would be removed. center, hospital, and OPO. We proposed emergency preparedness need to be transported during an • emergency. Most OPOs are not Revising § 486.360(e) to state that requirements based on the requirements recovering brain-dead donors every day OPOs can satisfy the agreement that we proposed for hospitals, modified and might or might not choose to move requirement by having at least one other to address the specific characteristics of a potential donor depending upon the location from which they could operate RHCs and FQHCs. We do not believe all donor’s condition. However, we would from within their DSA or a plan to set of these requirements are appropriate encourage transplant centers, the up an alternate location during an for RHCs/FQHCs, which serve only hospitals in which they are located, and emergency as part of its emergency plan outpatients. We did not propose to OPOs to address this possibility in their as required by § 486.360(a). require RHC/FQHCs to provide basic • Adding § 486.360(f) to allow a emergency preparedness protocols as subsistence needs for staff and patients. separately certified OPO within a Also, unlike that proposed for hospitals finalized in this rule. In addition, the healthcare system to elect to be a part at § 482.15(b)(2), we did not propose commenter’s request involves changes of the healthcare system’s emergency that RHCs/FQHCs have a system to track to the state operations manual and preparedness program. the location of staff and patients in the Medicare’s policy on cost reports. These facility’s care both during and after the are payment policy issues and are R. Emergency Preparedness Regulations emergency. outside of the scope of this regulation. for Rural Health Clinics (RHCs) and At § 482.15(b)(3), we proposed that After consideration of the comments Federally Qualified Health Centers hospitals have policies and procedures we received on these provisions, and (FQHCs) (§ 491.12) for safe evacuation from the hospital, the general comments we received on As of June 2016, there were a which includes consideration of care the proposed rule, as discussed in the combined total of 11,500 RHCs and and treatment needs of evacuees; staff hospital section (section II.C. of this FQHCs. Section 1861(aa) of the Act sets responsibilities; transportation; final rule, we are finalizing the forth the rural health clinic (RHC) and identification of evacuation location(s); proposed emergency preparedness federally qualified health center (FQHC) and primary and alternate means of requirements for OPOs with the services covered by the Medicare and communication with external sources of following modifications: Medicaid program. RHCs must be assistance. Therefore, at § 491.12(b)(1), • Revising the introductory text of located in an area that is both a rural we proposed to require that RHCs/ § 486.360 by adding the term ‘‘local’’ to area and a designated shortage area. FQHCs have policies and procedures for clarify that OPOs must also comply with Conditions for Certification for RHCs evacuation from the RHC/FQHC, local emergency preparedness and Conditions for Coverage for FQHCs including appropriate placement of exit requirements. are found at 42 CFR part 491, subpart signs, staff responsibilities, and needs of • Revising § 486.360(a)(4) by deleting A. Current emergency preparedness the patients. the term ‘‘ensuring’’ and replacing the requirements are found at § 491.6(c). Unlike the requirement that was term ‘‘ensure’’ with ‘‘maintain.’’ We proposed that the RHCs’ and proposed for hospitals at § 482.15(b)(7), • Revising § 486.360(b)(1) by FQHCs’ emergency preparedness plans we did not propose that RHCs/FQHCs clarifying that tracking during and after address the type of services the facility have arrangements with other RHCs/ the emergency applies to on-duty staff has the capacity to provide in an FQHCs or other providers and suppliers and any staff that are relocated during emergency. to receive patients in the event of an emergency. Also, we revised Although RHCs and FQHCs currently limitations or cessation of operations to paragraph (b)(1) to provide that if on- do not have specific requirements for ensure the continuity of services to duty staff are relocated during the emergency preparedness, they have RHC/FQHC patients. We did not emergency, the facility must document requirements for ‘‘Emergency propose to require RHC/FQHCs to the specific name and location of the Procedures’’ found at § 491.6, under comply with the proposed hospital receiving facility or other location. ‘‘Physical plant and environment.’’ At requirement at § 482.15(b)(8) regarding • Revising § 486.360(b)(2) to change § 491.6(c)(1), the RHC or FQHC must alternate care sites. the phrase ‘‘ensures records are secure train staff in handling non-medical In addition, we would not require and readily available’’ to secures and emergencies. This requirement would RHCs/FQHCs to comply with the maintains availability of records.’’ be addressed at proposed § 491.12(d)(1). proposed requirement for hospitals

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found at § 482.15(c)(5), which would and FQHCs can include these policies • Adding § 491.12(e) to allow require that a hospital have a means, in and procedures if they believe it is separately certified RHCs and FQHCs the event of an evacuation, to release appropriate for their facility. within a healthcare system to elect to be patient information as permitted under Comment: A commenter stated that a part of the healthcare system’s 45 CFR 164.510. Modified from what small facilities such as an FQHC or RHC emergency preparedness program. has been proposed for hospitals at should be exempt from conducting a S. Emergency Preparedness Regulation § 482.15(c)(7), at § 491.12(c)(5), we risk assessment. Another commenter for End-Stage Renal Disease (ESRD) proposed to require RHCs/FCHCs to stated that clinics should be required to Facilities (§ 494.62) have a communication plan that would have a plan to utilize volunteers in an include a means of providing emergency. Sections 1881(b), 1881(c), and information about the RHCs/FQHCs Response: We disagree with removing 1881(f)(7) of the Act establish needs and their ability to provide the risk assessment requirement for requirements for end-stage renal disease assistance to the local health FQHCs and RHC. As we have stated (ESRD) facilities. ESRD is a kidney department or emergency management earlier in this document, conducting a impairment that is irreversible and authority having jurisdiction or the risk assessment is essential to permanent and requires either a regular Incident Command Center, or designee. developing an emergency preparedness course of dialysis or kidney We did not propose to require RHCs/ plan. Clinics will have the flexibility to transplantation to maintain life. Dialysis FQHCs to provide information regarding include volunteers in their emergency is the process of cleaning the blood and their occupancy, as we propose for plan as indicated by their individual removing excess fluid artificially with hospitals, since the term occupancy risk assessments. We would expect special equipment when the kidneys usually refers to bed occupancy in an RHCs and FQHCs to develop strategies have failed. As of June 2016, there were inpatient facility. for addressing emergency events 6,648 Medicare-participating ESRD Comment: A commenter supported identified by their risk assessments. facilities in the U.S. We addressed emergency CMS’ proposal to exempt FQHCs from After consideration of the comments releasing patient information as preparedness requirements for ESRD we received on these provisions, and facilities in the April 15, 2008 final rule permitted under HIPAA 45 CFR part the general comments we received on 164 in the case of an emergency or (73 FR 20370) titled, ‘‘Conditions for the proposed rule, as discussed Coverage for End-Stage Renal Disease disaster. previously and in the hospital section Another commenter opposed CMS’ Facilities; Final Rule.’’ Emergency (section II.C. of this final rule, we are proposed requirements for a preparedness requirements are located finalizing the proposed emergency communication plan for RHCs and at § 494.60(d), Condition: Physical preparedness requirements for RHCs FQHCs. The commenter stated their environment, Standard: Emergency and FQHCs with the following belief that RHCs and FQHCs should preparedness. We proposed to relocate modifications: provide some level of patient clinical • these existing requirements to proposed information during a disaster. The Revising the introductory text of § 494.62, Emergency preparedness. commenter noted the importance of § 491.12 by adding the term ‘‘local’’ to Current regulations include the sharing patient information with other clarify that RHCs and FQHCs must also requirement that dialysis facilities be hospitals that may be receiving coordinate with local emergency organized into ESRD Network areas. Our preparedness requirements. regulations describe these networks at evacuated patients during an emergency • or a disaster. Furthermore, the Revising § 491.12(a)(4) by deleting § 405.2110 as CMS-designated ESRD commenter noted that these records the term ‘‘ensuring’’ and replacing the Networks in which the approved ESRD term ‘‘ensure’’ with ‘‘maintain.’’ facilities collectively provide the should be available online through an • EMR or through another procedure for Revising § 491.12(b)(3) to change necessary care for ESRD patients. The providing patient information. the phrase ‘‘ensures records are secure ESRD Networks have an important role Response: We appreciate the and readily available’’ to ‘‘secures and in an ESRD facility’s response to commenter’s support. We continue to maintains availability of records.’’ emergencies, as they often arrange for believe that RHCs and FQHCs should • Revising § 491.12(c) by adding the alternate dialysis locations for patients not be required to comply with the term ‘‘local’’ to clarify that RHCs and and provide information and resources proposed requirement for hospitals, FQHCs must develop and maintain an during emergency situations. As noted which would require that a hospital emergency preparedness earlier, we do not propose incorporating have a means, in the event of an communication plan that also complies the ESRD Network requirements into evacuation, to release patient with local laws. this proposed rule. We did not propose information as permitted under 45 CFR • Revising § 491.12(d) by adding that to require ESRD facilities to provide 164.510. RHCs and FQHCs are not a RHC and FQHC’s training and testing basic subsistence needs for staff and inpatient facilities that would transfer program must be based on the RHC and patients, whether they evacuate or patients to another facility during an FQHC’s emergency plan, risk shelter in place, including food, water, evacuation. Because they operate on an assessment, policies and procedures, and medical supplies; alternate sources outpatient basis, whereby during an and communication plan. of energy to maintain temperatures to emergency the facility would close and • Revising § 491.12(d)(1)(iv) to protect patient health and safety and for cancel appointments, we do not believe replace the phrase ‘‘ensure that staff can the safe and sanitary storage of that it is necessary for RHCs and FQHCs demonstrate knowledge’’ to provisions; emergency lighting; and fire to be mandated to provide patient ‘‘demonstrate staff knowledge.’’ detection, extinguishing, and alarm information during an evacuation. • Revising § 491.12(d)(2)(i) by systems; and sewage and waste disposal However, we note that RHCs and replacing the term ‘‘community mock as we proposed for hospitals at FQHCs are not precluded from disaster drill’’ with ‘‘full-scale exercise.’’ § 482.15(b)(1). including policies and procedures in • Revising § 491.12(d)(2)(ii) to allow a At § 494.62(b), we proposed to require their communication plan to share RHC and FQHC to choose the type of facilities to address in their policies and patient information during an exercise it will conduct to meet the procedures, fire, equipment or power emergency with other facilities. RHCs second annual testing requirement. failures, care-related emergencies, water

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supply interruption, and natural We proposed to redesignate current document, Homeland Security Exercise disasters in the facility’s geographic § 494.60(d). Current requirements for and Evaluation Program Terminology, area. emergency plans at § 494.60 were Methodology, and Compliance At § 482.15(b)(3), we proposed that captured within proposed § 494.62(a). Guidelines (HSEEP). The term ‘‘Incident hospitals have policies and procedures Current language that defines an Command Center’’ in § 494.62(c)(7) is for the safe evacuation from the emergency for dialysis facilities found at not an Incident Command System (ICS) hospital, which includes consideration § 494.60(d) would be incorporated into or National Incident Management of care and treatment needs of evacuees; proposed § 494.62(b). We proposed to System (NIMS) term. staff responsibilities; transportation; relocate existing requirements for Response: We understand that the identification of evacuation location(s); emergency equipment and emergency commenter is concerned with this rule’s and primary and alternate means of drugs found at existing § 494.60(d)(3) to inconsistencies with terminology used communication with external sources of § 494.62(b)(9). We proposed to relocate in the disaster and emergency response assistance. We do not believe all of the existing requirement at planning community. Providers and these requirements are appropriate for § 494.60(d)(4)(i) that requires the facility suppliers use various terms to refer to ESRD facilities, which serve only to have a plan to obtain emergency the same function and we have used the outpatients. Therefore, at § 494.62(b)(2), medical system assistance when needed term ‘‘Incident Command Center’’ in we proposed to require that ESRD to proposed § 494.62(b)(8). We proposed this rule to mean ‘‘Operations Center’’ facilities have policies and procedures to relocate the current requirements at or ‘‘Incident Command Post.’’ After this for evacuation from the facility, § 494.60(d)(4)(iii) for contacting the final rule is published, interpretive including staff responsibilities and local health department and emergency guidance will be published by CMS that needs of the patients. preparedness agency at least annually to will provide additional clarification. Comment: A few commenters At § 494.62(b)(6), we proposed to ensure that the agency is aware of indicated their support for requiring require ESRD facilities to develop dialysis facility’s needs in the event of ESRD facilities to develop training and arrangements with other dialysis an emergency to proposed testing programs. The commenters facilities or other providers and § 494.62(a)(4). We also proposed to stated that given the often medically suppliers to receive patients in the event redesignate the current § 494.60(e) as fragile population that ESRD facilities of limitations or cessation of operations § 494.60(d). serve and the risk of service disruption to ensure the continuity of services to Comment: Some commenters agreed with the proposal to require ESRD during an emergency, it would be dialysis facility patients. At providers to develop and maintain an beneficial for these facilities to train § 494.62(c)(7), dialysis facilities would emergency preparedness their staff and educate their patients be required to comply with the communication plan. Several regarding steps they can take to prepare proposed requirement for hospitals at commenters disagreed with the themselves for emergency situations. A § 482.15(c)(7), with one exception. At implementation of the emergency commenter expressed support while § 494.62(c)(7), we proposed to require preparedness communication plan also reiterating that existing dialysis facilities to have a requirements for dialysis facilities. A requirements for ESRD facilities require communication plan that include a commenter noted that the current CfCs staff to be trained in emergency means of providing information about require dialysis facilities to have at least procedures. A commenter also their needs and their ability to provide annual contact with the local disaster expressed their support for allowing assistance to the authority having management agency. ESRD facilities to initiate a facility jurisdiction or the Incident Command A commenter agreed with the based mock drill in the absence of a Center, or designee. We did not propose proposal that exempts ESRD facilities community drill since participation in a to require dialysis facilities to provide from having to provide information community disaster drill has been information regarding their occupancy, regarding occupancy since, according to difficult at times. as we proposed for hospitals, since the the commenter, the facilities do not Response: We thank these term occupancy usually refers to bed serve outpatient and do not routinely commenters for their support and agree occupancy in an inpatient facility. accommodate overnight stays. that emergency preparedness training At § 494.62(d)(1)(i), we proposed to Response: We appreciate the and testing will benefit not only the staff require ESRD facilities to ensure that commenters’ support. We continue to of the ESRD facilities, but will also have staff can demonstrate knowledge of believe that ESRD facilities should a positive impact on the patients that various emergency procedures, develop and maintain a communication they serve. We also encourage ESRD including: informing patients of what to plan so that the facility can be prepared facilities to be proactive on preparing do; where to go, including instructions to communicate with the local health for emergencies. For example, it is for occasions when the geographic area department, emergency management essential that dialysis patients and their of the dialysis facility must be and other emergency preparedness caregivers have all of their essential evacuated; and whom to contact if an officials during an emergency or a documentation, such as their doctor’s emergency occurs while the patient is disaster. We are not requiring dialysis orders or scripts, medical history, etc. not in the dialysis facility. facilities to provide information Comment: A commenter noted that We proposed to relocate existing regarding their occupancy, as we are with advance notice many dialysis requirements for patient training from requiring for hospitals, since the term patients can evacuate and find shelter § 494.60(d)(2) to proposed occupancy refers to bed occupancy in with families and friends. However, § 494.62(d)(3), patient orientation. In an inpatient facility. they many have difficulty getting to addition, the facility would have to Comment: A commenter stated that another dialysis facility due to problems ensure that, at a minimum, patient care the language used in this section was with transportation. The commenter did staff maintained current CPR vague and erroneously technical. This acknowledge that providing or arranging certification and ensure that nursing commenter specifically noted that the for transportation is beyond the scope of staff were properly trained in the use of term ‘‘community mock disaster drill’’ individual dialysis facilities, but they emergency equipment and emergency in § 494.62(d)(2)(i) was not consistent believed it should be addressed at a drugs. with the terminology used in the regional level.

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Response: We agree with the requirement about having policies and designated healthcare professionals to commenter that transportation may be a procedures that address the role of the address surge needs during an problem for some dialysis patients that dialysis facility under a waiver declared emergency. We believe that each facility need to evacuate and that arranging for by the Secretary, in accordance with needs the flexibility to determine how transportation in other areas is beyond section 1135 of the Act, in the provision they should use volunteers during an the scope of responsibility for of care and treatment at an alternate care emergency. If the facility is located in a individual dialysis facilities. However, site identified by emergency state where there is a volunteer registry, these facilities are required to provide management officials (§ 494.62(b)(7)). A that is certainly a valuable resource for emergency preparedness patient commenter inquired about nurses using any healthcare facility and we would training, which includes instructions on protocols and what was CMS guidance encourage the use of that registry. what to do if the geographic area in on this. Another commenter thought However, we do not believe that this which the dialysis facility is located that the requirement was vague and should be a requirement in this final must be evacuated (§ 494.62(d)(3)). We stated that further guidance was needed. rule. We also agree with the other expect that instructions on who to This commenter noted that providers commenter and encourage dialysis contact for assistance would be may request waivers and that facilities facilities to utilize assistance from the included in that training. were unlikely to have a policy beyond MRC and ESAR–VHP. Comment: Some commenters either the facility’s statement that they Comment: Some commenters noted questioned our proposed requirement would comply with the waiver or a that we did not require dialysis facilities for policies and procedures that address procedure on how to request a waiver. to provide basic subsistence needs for having a process by which the staff Response: We believe that these their staff and patients during an could confirm that emergency issues are more appropriately addressed emergency. A commenter agreed with equipment, including emergency drugs, in sub-regulatory guidance. After this not requiring the provision of were on the premises at all times and final rule is published, further guidance subsistence needs. However, another immediately available (§ 494.62(b)(9)). A will be provided on how facilities commenter requested clarification on commenter stated that this requirement should comply with this requirement. why this was not a requirement for concerns clinical practice policies that Comment: A commenter suggested dialysis facilities and recommended are outside the purview of emergency revising our proposed requirement for requiring subsistence need for at least a preparedness. They noted that while the dialysis facilities to have policies and short period of time. needs of an individual patient in an procedures that address ‘‘(6) The Response: We continue to believe that emergency may require that the facility development of arrangements with other it is not appropriate to require that enact it emergency response plans, that dialysis facilities or other providers to dialysis facilities provide subsistence the needs of an individual patient receive patients in the event of needs for either their staff or patients. would not require the activation of the limitations or cessation of operations to Based on our experience with dialysis facility’s emergency preparedness plan. maintain the continuity of services to facilities, we expect that most facilities Another commenter questioned if we dialysis facility patients.’’ That would discharge any patients in their would be providing a list of emergency commenter suggested modifying the facility as soon as possible if they are drugs and specifying the quantities of language to read ‘‘multiple unable to provide services. Therefore, those drugs that the dialysis facility prearrangements with other dialysis requiring subsistence needs should not would be expected to have at their facilities . . .’’ be necessary. However, we want to facility. Response: We disagree with the emphasize that the requirements in this Response: We disagree with commenter. The proposed requirement final rule are the minimum commenter on this requirement being uses the plural, ‘‘arrangements.’’ We requirements that dialysis facilities beyond the scope of this regulation. We believe that clearly indicates that must meet to participate in the Medicare are not attempting to regulate clinical dialysis facilities are expected to have program. Every facility must develop practice. This section only requires that more than one arrangement with other and maintain its own emergency plan the staff have a process to ensure that facilities to maintain continuity of based on its risk assessment as required emergency equipment is on the services to their patients. Thus, we will by § 494.62(a). Based on their risk premises and available during an be finalizing the requirement as assessment, any dialysis facility could emergency. While we have listed some proposed. decide that it should provide basic emergency equipment that should Comment: A commenter suggested subsistence needs and for what be available during any care-related that dialysis facilities, as well as other duration. emergency, it is the facility’s providers, have a requirement to use Comment: A commenter noted that responsibility to determine what volunteer management registries. implementing the requirement for a emergency equipment it needs to have Another commenter was supportive of dialysis facility to track staff and available. In addition, dialysis facilities ESRD facilities using the Medical patients during and after an emergency need to be able to manage care-related Reserve Corps (MRC) and the include routine calls with the Kidney emergencies during an emergency when Emergency System for Advance Community Emergency Response other assistance, such as EMTs and Registration of Volunteer Health (KCER). KCER is a part of the Network ambulances, may not be immediately Professional (ESAR–VHP) as discussed Coordinating Center (NCC) that works available to them. This final rule does in the hospital section of the proposed with all 18 of the ESRD networks. KCER not contain any specific list of rule (78 FR 79097). is the leading authority on emergency emergency drugs or specify any Response: We are finalizing the preparedness and response for the ESRD quantities of drugs to have at a facility. requirement that is set forth in Network community with leadership That is beyond the scope of this rule. § 494.62(b)(5) that dialysis facilities and management delegated to the KCER After this rule is finalized, there may be have policies and procedures that staff under authority and direction of additional sub-regulatory guidance address the use of volunteers in an CMS. concerning this requirement. emergency or other emergency staffing Response: We agree with the Comment: Some commenters strategies, including a process and role commenter that KCER is an essential requested clarification on the for integration of state and federally resource for the ESRD community. We

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recommend that dialysis facilities best training tool for familiarizing the or requirements on how dialysis utilize this resource in their emergency leadership and staff in emergency facilities are to interact with coalitions. preparedness activities. However, we procedures is through experiencing Comment: A commenter believed that believe that any specific requirements actual plan activation. dialysis facilities and the ESRD concerning communications in the Response: We agree that emergency Networks should be provided funding ESRD community should be established plans must be activated for staff and the for the equipment that would be needed in sub-regulatory guidance. leadership to both get experience with to comply with the requirement for a Comment: Concerning our proposed the emergency procedures and test the communication plan (§ 494.62(c)). The requirement for dialysis facilities to plan. For that reason, we are finalizing commenter specifically proposed have policies and procedures for a the requirements for training and testing funding for cellular devices and satellite system to track the location of staff and the emergency plan. However, we also communications technology for the patients in the dialysis facility’s care believe that any facility that has had to ESRD Networks and GETS/WPS to both during and after the emergency, a activate their plan due to an actual ensure communications between commenter stated that it would be emergency meets the requirements in providers and emergency management reasonable for CMS to propose specific this final rule and requiring another resources providing direction during technology standards to make full-scale drill would be burdensome. emergencies. compatibility with electronic medical Therefore, we are finalizing the Response: This rule finalizes the records (EMR) systems a reality. The exemption contained in § 494.62(d)(2)(i) emergency preparedness requirements commenter noted that reliance on print as proposed. for dialysis facilities in § 494.62 of the records is tenuous at best and this is Comment: A commenter wanted more ESRD CfCs. Dialysis facilities must associated with quick onset of an specificity concerning the federal law(s) comply with all of their CfCs to be emergency. that dialysis facilities would be required certified by Medicare and must do so Response: We acknowledge that EMRs to comply with in accordance with within the payments they received from would be very helpful in transitions in proposed § 494.62(c). The commenter Medicare. care and in locating patients. However, wanted us to specifically state the Comment: A commenter notes that the specific technology standards for an federal law(s) to which the dialysis the proposed rule allowed for an EMR system suggested by the facilities would need to comply. exemption from an exercise after plan commenter are beyond the scope of this Response: Federal laws, as well as activation (proposed § 494.62(d)(2)). final rule. state and local laws, can be modified by Comment: A commenter believed that the appropriate legislative bodies and They recommended that it would be there was a contradiction between the executives at any time. In addition, necessary for at least one component of preamble language (‘‘[w]e do not dialysis facilities are already required to the emergency plan specify what propose to require ESRD facilities to comply with the applicable federal, action(s) constitute activation of the provide basic subsistence needs for staff state, and local laws and regulations plan. and patients, whether they evacuate or that pertain to both their licensure and Response: We agree with the shelter in place, including food, water any other relevant health and safety commenter. Although it is not a and medical supplies . . . (78 FR requirements (§ 494.20). Since the specifically required component of the 79116)) and the requirement in requirements we are finalizing are in the emergency plan, we do believe that each proposed § 494.62(b)(3). The proposed dialysis facilities’ CfC, these facilities plan should indicate under what section required dialysis facilities to must already comply with all of the circumstances it would be deemed to be have policies and procedures that applicable federal, state, and local law activated. addressed a means to shelter in place for and regulation concerning their Comment: A commenter stated that patients, staff, and volunteers who licensure and health and safety we had erroneously attributed some remain in the facility. The commenter standards and are responsible for type of collective authority and recommended that we provide further knowing those laws and regulations. emergency assistance ability to the clarity and guidance on what is Thus, we are finalizing § 494.62(c) as ESRD Networks. These are expected in the rule. proposed. administrative governing bodies and Response: We apologize for any Comment: A commenter noted that liaisons with the federal government. confusion. However, in the language we, as well as other HHS documents, They stated that the increased cited by the commenter, we were stating suggest utilizing healthcare coalitions responsibilities imposed on the dialysis that we were not proposing any and that more descriptive terminology facilities by this rule would result in requirement related to subsistence would be necessary to indicated at what confusion within the ESRD community. needs associated with evacuation or level facilities and the Networks should Response: We understand the sheltering in place, not that we were not be expected to act with emergency commenter’s concerns. However, we proposing a requirement for the dialysis management at all of those levels. will be providing further sub-regulatory facility to have policies and procedures Response: Commenting on other HHS guidance after publication of this final that address sheltering in place. We are documents is beyond the scope of this rule. The guidance should provide more finalizing § 494.62(b)(3) as proposed. final rule. We have encouraged the specific guidance for the ESRD Comment: A commenter disapproved providers and suppliers covered by this community on how to comply with the of allowing a one-year exemption from final rule to form and work with requirements in this final rule. the requirement for a full-scale exercise healthcare coalitions or both. However, After consideration of the comments if the facility experienced an actual that would be their choice, it is not we received on these provisions, and emergency that required activation of required. In addition, since coalitions the general comments we received on their emergency plan. The commenter may be organized in different ways, it the proposed rule, as discussed earlier noted that appropriate and frequent would be difficult to provide specific and in the hospital section (section II.C. activation are key to an emergency requirements on how providers and of this final rule), we are finalizing the management plan success and that early suppliers are to interact with them. proposed emergency preparedness but unnecessary plan activation is better Therefore, we do not believe it is requirements for ESRD facilities with than a needed but future activation. The appropriate to provide specific guidance the following modifications:

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• Revising the introductory text of III. Provisions of the Final Regulations clarify that facilities must develop and § 494.62 by adding the term ‘‘local’’ to maintain an emergency preparedness A. Changes Included in the Final Rule clarify that dialysis facilities must also communication plan that also complies comply with local emergency In this final rule, we are adopting the with local law. preparedness requirements. provisions of the December 27, 2013 • For RNHCIs, ASCs, hospices, • Revising § 494.62(a)(4) by deleting proposed rule (78 FR 79082) with the PRTFs, PACE organizations, hospitals, the term ‘‘ensuring’’ and replacing the following revisions: LTC facilities, ICF/IIDs, CAHs, CMHCs, • For all provider and supplier types, term ‘‘ensure’’ with ‘‘maintain.’’ and dialysis facilities, we are clarifying we are making a technical revision to • that these provider and supplier types Revising § 494.62(b)(1) by clarifying clarify that facilities must also must have a means, in the event of an that tracking during and after the coordinate with local emergency evacuation, to release patient emergency applies to on-duty staff and preparedness systems. information as permitted under 45 CFR sheltered patients. We have also revised • For RNHCIs, inpatient hospices, 164.510(b)(1)(ii). paragraph (b)(1) to provide that if on- CAHs, ASCs, and hospitals, we are • For all provider and supplier types duty staff and sheltered patients are removing the requirement for facilities with the exception of RNHCIs, OPOs, relocated during the emergency, the to track all staff and patients after an and transplant centers, we are revising dialysis facility must document the emergency and clarifying that in the testing requirements by replacing the specific name and location of the event on-duty staff and sheltered term ‘‘community mock disaster drill’’ receiving facility or other location. patients are relocated during an with ‘‘full-scale exercise.’’ • Revising § 494.62(b)(4) to change emergency, the provider/supplier must • For ASCs only, we are removing the the phrase ‘‘ensures records are secure document the specific name and requirement for participation in a and readily available’’ to ‘‘secures and location of the receiving facility or other community-based testing exercise and maintains availability of records.’’ location for staff and patients who leave revising the requirement to only require • Revising § 494.62(b)(6) to replace the facility during the emergency. ASCs to conduct an individual, facility- • For home based hospices and based full scale testing exercise. the term ‘‘ensure’’ with ‘‘maintain.’’ • • HHAs, we are removing the tracking For all provider and supplier types Revising § 494.62(b)(8) to delete the requirement and requiring that in the with the exception of RNHCIs, OPOs, phrase ‘‘a process to ensure that’’ and event there is an interruption in services and transplant centers, we are revising replacing the term with ‘‘How.’’ during or due to an emergency, the testing requirements to allow each • Revising § 494.62(b)(9) to delete the provider must have policies in place for facility to choose the type of exercise phrase ‘‘ensuring that’’ and replacing it following up with on-duty staff and they must conduct to meet the second with the term ‘‘by which the staff can patients to determine services that are annual testing requirement. confirm.’’ still needed. In addition, they must • For hospitals, CAHs, and LTC • Revising § 494.62(c), by adding the inform state and local officials of any facilities, we are revising emergency and term ‘‘local’’ to clarify that the dialysis on-duty staff or patients that they are standby power system requirements by facility must develop and maintain an unable to contact. removing the requirement for an • emergency preparedness For ESRD facilities, CMHCs, LTC additional 4 hours of generator testing communication plan that also complies facilities, ICF/IIDs, PACE organizations, and clarifying that a facility must meet ® with local laws. PRTFs, and OPOs we are clarifying that the requirements of NFPA 99 2012 tracking during and after the emergency ® • Revising § 494.510(c)(5) to clarify edition and NFPA 110, 2010 edition. applies to on-duty staff and sheltered • For hospitals, CAHs, and LTC that the dialysis facility must develop a patients. We have also revised the facilities, we are revising emergency and means, in the event of an evacuation, to regulations to provide that if on-duty standby power system requirements by release patient information, as permitted staff and sheltered patients are relocated removing the requirement that a facility under 45 CFR 164.510(b)(1)(ii). during the emergency, the facility must must maintain fuel onsite and clarifying • Revising § 494.62(d) by adding that document the specific name and that facilities must have a plan to each dialysis facility’s training and location of the receiving facility or other maintain operations unless the facility testing program must be based on the location. evacuates. dialysis facility’s emergency plan, risk • We did not propose a tracking • For all provider and supplier types, assessment using an all hazards requirement for CORFs, RHCs, FQHCs, we are adding a separate standard to the approach, policies and procedures, and transplant centers, and Organizations regulations text that will allow a communication plan. and have not made any revisions separately certified healthcare facility • Revising § 494.62(d)(1)(iii) to regarding tracking for these facilities in within a healthcare system to elect to be replace the phrase ‘‘ensure that staff can this final rule. a part of the healthcare systems unified demonstrate knowledge’’ to • For ASCs and HHAs, we are emergency preparedness program. removing the requirement that ASCs ‘‘demonstrate staff knowledge.’’ B. Incorporation by Reference • Revising § 494.62(d)(2)(i) by and HHAs develop arrangements with In this final rule, we are incorporating replacing the term ‘‘community mock other ASCs/HHAs and other providers by reference the NFPA 101® 2012 disaster drill’’ with ‘‘full-scale exercise.’’ to receive patients in the event of edition of the LSC, issued August 11, • limitations or cessation of operations to Revising § 494.62(d)(2)(ii) to allow a ensure the continuity of services to 2011, and all Tentative Interim dialysis facility to choose the type of patients. Amendments issued prior to April 16, exercise it will conduct to meet the • For ASCs and HHAs, we are 2014; the NFPA 99® 2012 edition of the second annual testing requirement. removing the requirement that the Health Care Facilities Code, issued • Adding § 494.62(e) to allow a communication plan include the names August 11, 2011, and all Tentative separately certified dialysis facilities and contact information for other ASCs/ Interim Amendments issued prior to within a healthcare system to elect to be HHAs. April 16, 2014; and the NFPA 110 ® a part of the healthcare system’s • For all provider and supplier types, 2010 edition of the Standard for emergency preparedness program. we are making a technical revision to Emergency and Standby Power

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Systems(including Tentative Interim IV. Collection of Information documenting policies and procedures to Amendments to chapter 7), issued Requirements mitigation potential challenges that may August 6, 2009. Under the Paperwork Reduction Act arise depending on the identified in • NFPA® 99, Health Care Facilities of 1995, we are required to provide 30- their risk assessment. We also reference Code, 2012 edition, issued August 11, day notice in the Federal Register and numerous resources in the preamble 2011. that are available for use by providers ++ TIA 12–2 to NFPA® 99, issued solicit public comment before a collection of information requirement is and suppliers to help develop their risk August 11, 2011. assessments. Also, in the final rule, we ® submitted to the Office of Management ++ TIA 12–3 to NFPA 99, issued allow providers and suppliers who are and Budget (OMB) for review and August 9, 2012. part of integrated health systems to ® approval. In order to fairly evaluate ++ TIA 12–4 to NFPA 99, issued develop one risk assessment and we whether an information collection March 7, 2013. encourage them to work with their ® should be approved by OMB, section ++ TIA 12–5 to NFPA 99, issued community health coalitions in doing 3506(c)(2)(A) of the Paperwork August 1, 2013. so. As a result, we expect that it will ® Reduction Act of 1995 requires that we ++ TIA 12–6 to NFPA 99, issued take more time to complete the solicit comment on the following issues: March 3, 2014. emergency plan in comparison to the • NFPA® 101, Life Safety Code, 2012 • The need for the information amount of time it will take to conduct edition, issued August 11, 2011; collection and its usefulness in carrying ® a risk assessment as the emergency plan ++ TIA 12–1 to NFPA 101, issued out the proper functions of our agency. must be unique to the specific facility to August 11, 2011. • The accuracy of our estimate of the ++ TIA 12–2 to NFPA® 101, issued which it applies. information collection burden. In each section, where possible, we October 30, 2012. • The quality, utility, and clarity of ++ TIA 12–3 to NFPA® 101, issued provide information regarding the the information to be collected. characteristics which drive burden for October 22, 2013. • Recommendations to minimize the ++ TIA 12–4 to NFPA® 101, issued each provider and supplier type. information collection burden on the Current Medicare or Medicaid October 22, 2013. affected public, including automated • NFPA® 110, Standard for regulations for some providers and collection techniques. suppliers include requirements similar Emergency and Standby Power Systems, We are soliciting public comment on 2010 edition, including TIAs to chapter to those in this regulation. For example, each of these issues for the following existing regulations for RNHCIs and 7, issued August 6, 2009. sections of this document that contain The materials that are incorporated by dialysis facilities require both types of information collection requirements reference are reasonably available to facilities to have written disaster plans (ICRs). interested parties and can be inspected that address emergencies (42 CFR at the CMS Information Resource A. Factors Influencing ICR Burden 403.742(a)(4) and 42 CFR 494.60(d)(4), Center, 7500 Security Boulevard, Estimates respectively). Baltimore, MD. Copies may be obtained We have determined that the time Please note that under this final rule, from the National Fire Protection required to conduct an annual review a hospital’s ICRs will differ from the Association, 1 Batterymarch Park, and update of the emergency ICRs of other Medicare or Medicaid Quincy, MA 02169, www.nfpa.org, preparedness plan is dependent upon provider and supplier types. We have 1.617.770.3000. If any changes in this whether there are existing emergency calculated the ICR for each provider and edition of the Code are incorporated by preparedness requirements for the supplier separately and have included a reference, CMS will publish a document providers and suppliers. We believe that chart summarizing the burden at the in the Federal Register to announce the the providers and suppliers with end of each section. A significant factor changes. existing emergency preparedness The NFPA 101® 2012 edition of the in the burden for each provider or requirements have some sort of an LSC (including the TIAs) provides supplier type will be whether the type emergency preparedness plan that is minimum requirements, with due of facility provides inpatient services, updated at least annually based on regard to function, for the design, outpatient services, or both. Moreover, current standards of practice. For these operation and maintenance of buildings even where the regulatory requirements providers and suppliers, no additional and structures for safety to life from fire. are the same, certain factors will greatly burden has been assigned for the annual Its provisions also aid life safety in affect the burden for different providers review and update of the emergency similar emergencies. and suppliers, such as the size and preparedness plan. The following The NFPA 99® 2012 edition of the location of the provider or supplier, providers and suppliers currently have Health Care Facilities Code (including whether or not they participate in any emergency preparedness requirements: the TIAs) provides minimum type of network, and whether they RNCHIs, ASCs, PACE organizations, requirements for health care facilities already have a substantial emergency Hospitals, ICF/IIDs, HHAs, CORFs, for the installation, inspection, testing, preparedness program. CAHs, Organizations, RHCs, FQHCs, maintenance, performance, and safe We have determined that the inpatient hospice, and ESRD facilities. practices for facilities, material, development of an emergency plan is For those providers and suppliers who equipment, and appliances, including more labor intensive than conducting do not have existing emergency other hazards associated with the the risk assessment for a few reasons. In preparedness requirements, we believe primary hazards. general, the risk assessment process that it is less likely that there is an The NFPA 110® 2010 edition of the requires following a checklist and/or emergency preparedness plan that is Standard for Emergency and Standby filling out a table (see: https:// reviewed and updated annually. For Power Systems (including the TIAs) asprtracie.hhs.gov/documents/tracie- these providers and suppliers, we provides minimum requirements for the evaluation-of-HVA-tools.pdf for a set of estimate that the time it takes to review installation, maintenance, operation, examples), whereas planning is a more and update the plan annually is equal and testing requirements as they pertain comprehensive process that requires to one-third of the amount of time it to the performance of the emergency individual expertise, identifying takes to develop their emergency power supply system (EPSS). mitigation options to problems, and preparedness plan. The following

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providers and suppliers currently do not that are not Medicare or Medicaid • http://asprtracie.hhs.gov/ Technical have emergency preparedness certified. Resources, Assistance Center, and requirements: CMHCs, OPOs, PRTFs Information Exchange (TRACIE). Unless otherwise indicated, we • and outpatient hospices. obtained all salary information for the http://www.phe.gov/about. Health Resources and Services Furthermore, some accrediting different positions identified in the Administration-Emergency organizations (AOs) that have CMS- following assessments from the May approved accreditation programs for Preparedness and Continuity of 2014 National Occupational Operations. Medicare providers and suppliers have Employment and Wage Estimates, • emergency preparedness standards. http://www.hrsa.gov/emergency/. United States by the Bureau of Labor Centers for Medicare and Medicaid Those organizations are: The Joint Statistics at http://www.bls.gov/oes/ Services (CMS). Commission (TJC), the American current/oes_nat.htm. In the proposed • www.cms.hhs.gov/Emergency/. Osteopathic Association/Healthcare rule we added a 30 percent increase for Centers for Disease Control and Facilities Accreditation Program (AOA/ overhead and benefits. For the final Prevention—Emergency Preparedness & HFAP), the Accreditation Association rule, we have calculated the estimated Response. for Ambulatory Health Care, Inc. hourly rates in this final rule based • www.emergency.cdc.gov. (AAAHC), the American Association for upon the national mean salary for that Food and Drug Administration Accreditation for Ambulatory Surgery particular position to include a 100 (FDA)—Emergency Preparedness and Facilities, Inc. (AAAASF), and Det percent increase for overhead and Response. • Norske Veritas (DNV) GL—Healthcare benefits. Where we were able to identify http://www.fda.gov/ (DNV GL). Each of these AOs has positions linked to specific providers or EmergencyPreparedness/default.htm. deeming authority for different types of suppliers, we used that compensation Substance Abuse and Mental Health facilities; for example, TJC has information. However, in some Services Administration (SAMHSA)— comprehensive emergency preparedness instances, we used a general position Disaster Readiness and Response. requirements for hospitals. Thus, as • http://www.samhsa.gov/Disaster/. description, such as director of nursing, noted in the hospital discussion later in National Institute for Occupational or we used information for comparable this section, we anticipate that TJC- Safety and Health (NIOSH)—Business positions. For example, we were not accredited hospitals will have a smaller Emergency Management Planning. able to locate specific information for burden associated with this final rule • www.cdc.gov/niosh/topics/emres/ physicians who practice in hospices. than many other providers or suppliers. business.html. However, since hospices provide In addition, many facilities already Department of Labor (DOL), palliative care, we used the Occupational Safety and Health have begun preparing for emergencies. compensation information for According to a study by Niska and Burt, Administration (OSHA)—Emergency physicians who work in specialty Preparedness and Response. virtually all hospitals already have hospitals. • plans to respond to natural disasters www.osha.gov/SLTC/ (Niska and Shimizu I. ‘‘Hospital Salary may be affected by the rural emergencypreparedness. Federal Emergency Management preparedness for emergency response: versus urban locations. For example, Agency (FEMA)—State Offices and United States, 2008.’’ National Health based on our experience with CAHs, Agencies of Emergency Management— Statistics Reports. (2011): 1–14). they usually pay their administrators less than the mean hourly wage for Contact Information. Hospitals, as well as other healthcare • http://www.fema.gov/about/ providers, also receive grant funding for Health Service Managers in general medical and surgical hospitals. Thus, contact/statedr.shtm. disaster or emergency preparedness • http://www.fema.gov/plan-prepare- from the federal and state governments, we considered the impact of the rural nature of CAHs to estimate the hourly mitigate. as well as other private and non-profit Department of Homeland Security entities. However, we were unable to wage for CAH administrators and calculated total compensation by adding (DHS). determine the amount of funding that • http://www.dhs.gv/training- in an amount for fringe benefits. Many has been granted to hospitals, the technical-assistance. number of hospitals that received healthcare providers and suppliers Comment: Multiple commenters funding, or whether that funding will could reduce their burden by partnering believe that we underestimated the continue in a predictable manner. We or collaborating with other facilities to amount of time and work it will take for also do not know how the hospitals develop their emergency management many providers and suppliers to come spent this funding. Therefore, in plans or programs. Due to a lack of data, into compliance with our proposed determining the burden for this final we did not consider this in our burden requirements. Specifically, some rule, we did not take into account any estimates. In estimating the burden commenters expressed that we did not funding a hospital or other healthcare associated with this final rule, we took truly capture what updating policies provider might have received from into consideration the many free or low and procedures will entail. The sources other than Medicare or cost emergency management resources commenters explained that updating Medicaid. healthcare facilities have available to policies and procedure will go beyond them and assume that many providers having meetings, drafting revisions, and B. Sources of Data Used in Estimates of will use only these resources in order to obtaining approvals. They expressed Burden Hours and Cost Estimates meet the requirements of this rule. If we that updating policies and procedures We obtained the data used in this feel an organization may hire a would also involve researching discussion on the number of the various consultant or contractor, we have alternatives, assessing costs that may be Medicare and Medicaid providers and indicated such. Following is a list of involved, reviewing potential changes suppliers from Medicare’s Certification some of the available resources: with affected employees, implementing and Survey Provider Enhanced Department of Health and Human the changes, and training staff and Reporting (CASPER) as of June 2016, Services (HHS), Office of the Assistant testing outcomes. unless indicated otherwise. We have not Secretary for Preparedness and Response: We appreciate the included data for healthcare facilities Response (ASPR). commenter’s feedback and understand

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their concerns. As discussed earlier in increase for overhead and benefits. In vary for each individual facility based the preamble, we recognize the level of this final rule, we have updated the on the unique circumstances of each work it will take for facilities to come salary data as indicated by the BLS data. facility. We provided a time estimate for into compliance with these The final rule salaries include a 100 the activities that, at a minimum, each requirements. While we understand that percent increase for overhead and facility will have to take into updating policies and procedures can benefits. Where we were able to identify consideration when conducting a involve many tasks and that for some positions linked to specific providers or community drill. facilities emergency preparedness suppliers, we used that compensation Comment: We received conflicting requirements may be new. We believe information. However, in some comments regarding the staff positions that periodically reviewing and instances, we used a general position that will be involved in the activities of updating policies and procedures is a description, such as director of nursing, developing the emergency preparedness standard business practice for or we used information for comparable programs. For example, one commenter healthcare facilities since they must positions. indicated that in addition to an comply with applicable federal, state, Comment: A commenter believes that administrator and director of nursing, a and local laws, regulations, and we miscalculated the time and expense plant manager and food service manager ordinances that periodically change. required in planning and carrying out a will also need to be included in the Adding disaster related policies may be community-based drill. The commenter process of developing the plan and a new task for some, but the process of believes that while most unaccredited conducting the risk assessment. Other updating policies and procedures will providers and suppliers probably would commenters indicated that the majority not be a brand new burden. As part of not be starting from scratch with regard of the burden associated with an annual review and update, staff are to drills and exercises, our description developing plans, updating policies and required to be trained and be familiar of the tasks and burdens associated with procedures, and facilitating/planning with many policies and procedures in organizing a drill is still insufficient. trainings and testing will fall on the the operation of their facility and are The commenter believes that we did not administrator. held responsible for knowing these provide a thorough explanation of what Response: Based upon our experience requirements. Annual reviews help to the emergency drill process would with the various providers and refresh these policies and procedures actually entail. The commenter points suppliers, we determined the staff which would include any revisions to out that planning would include tasks positions that would likely be involved them based on the facility experiencing such as contacting other providers and in complying with the varying an emergency or as a result of a community emergency response requirements for the different providers community or natural disaster. Basic agencies, convening with this group on and suppliers. The actual individuals contact information and procedures a regular basis, and writing the who are involved in the activities could be updated during an annual hospital’s part of the exercise. They also needed to comply with the requirements review. We would not expect that an suggest that participating in the drill in this final rule will vary based on the annual review would be an extensive would include recruiting volunteers, unique circumstances of each overhaul of their EP plan. Healthcare informing patients about the drill, and individual healthcare facility. Our facilities routinely revise and update obtaining financial approval to conduct estimates provide an overall idea of the policies and operational procedures to the drills. The commenter believes that necessary staff positions involved, but ensure that they are operating based on given all of this, it could more we note that ultimately the actual best practices. realistically take six months to a year to individuals involved will be determined Therefore, we accounted for the staff plan and carry out a comprehensive by the individual facility. We have time that will be involved to review and emergency drill and urges CMS to revise listed personnel that would address update current policies and procedures our estimates to more accurately reflect various components of the EP for alignment with these emergency the time and resources involved. requirements in both the ICR and RIA preparedness requirements. Response: The regulation would sections of the rule. Comment: Some commenters believe require some providers to participate in that we incorrectly estimated the a community-based training exercise C. ICRs Regarding Condition of salaries of the staff involved in meeting where available. We are not requiring Participation: Emergency Preparedness the requirements. A commenter facilities to plan and execute a (§ 403.748) questioned whether CMS could use community-wide exercise, only Section 403.748(a) will require average wages by region for determining participate to the extent their facility RNHCIs to develop and maintain an the salaries, rather than national average would contribute in an emergency emergency preparedness plan that must wages. The commenter believes that the situation if the whole community/town be reviewed and updated at least wages used in the proposed rule were is impacted. When a community-based annually. We proposed that the plan low for their area, therefore exercise is not accessible, facilities must meet the requirements specified at underestimating the estimates for would conduct a facility-based training. § 403.748(a)(1) through (4). We will conducting the risk assessment and As the commenter pointed out, we did discuss the burden for these activities developing the emergency plan. not provide prescriptive emergency individually beginning with the risk Response: As indicated in the exercises and drills. Instead, we assessment requirement in proposed rule, we obtained all salary provided resources that facilities can § 403.748(a)(1). information for the different positions utilize in developing their drills and The current RNHCI CoPs already identified in the following assessments exercises. The time estimates we used to require RNHCIs to have a written from the National Occupational calculate the burden associated with disaster plan that addresses ‘‘loss of Employment and Wage Estimates, conducting a drill for each provider and power, water, sewage, and other United States by the Bureau of Labor supplier were our best estimates for the emergencies’’ (42 CFR 403.742(a)(4)). In Statistics (BLS). We calculated the activity. Our estimates serve as a addition, the CoPs also require RNHCIs estimated hourly rates based upon the baseline for the time it will take to to include measures to evaluate facility national mean salary for that particular implement the task, understanding that safety issues, including physical position, including a 30 percent the actual time and task involved will environment, in their quality

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assessment and performance Based on our experience with hours), and the head of maintenance (2 improvement (QAPI) program (42 CFR RNHCIs, we expect that complying with hours) will attend an initial meeting; 403.732(a)(1)(vi)). We expect that all this requirement will require the review relevant sections of the current RNHCIs have considered some of the involvement of an administrator, the risk assessment; prepare comments; risks likely to happen in their facility. director of nursing, and the head of attend a follow-up meeting; perform a However, we expect that all RNHCIs maintenance. It is important to note that final review, and approve the risk will need to review any existing risk RNHCIs do not provide medical care to assessment. We expect that the director assessment and perform the tasks their patients. Depending upon the state of nursing will coordinate the meetings, necessary to ensure their assessment is in which they are located, RNHCIs may review and critique the current risk documented and utilize a facility-based not be licensed and may not have assessment, coordinate comments, and community based all-hazards licensed or certified staff. RNHCIs do develop the new risk assessment, and approach. not compensate their staff at the same ensure that it is approved. level we have used to determine the We have not designated any specific burden for other healthcare providers We estimate that it will require 9 process or format for RNHCIs to use in and suppliers. Therefore, for the burden hours for each RNHCI to conducting their risk assessment purpose of estimating the burden, we complete the risk assessment at a cost of because we believe they need the have used lower hourly wages for the $366. There are 18 RNHCIs. Therefore, flexibility to determine how best to RNHCI staff than for other providers and it will require an estimated 162 annual accomplish this task. However, we suppliers whose staff must comply with burden hours (9 burden hours for each expect that they will obtain input from licensing and certification standards. RNHCI × 18 RNHCIs) for all 18 RNHCIs all of their major departments in the We expect that to perform a risk to comply with this requirement at a process of developing their risk assessment, the RNHCI’s administrator cost of $6,588 ($366 estimated cost for assessments. (2 hours), the director of nursing (5 each RNHCI × 18 RNHCIs).

TABLE 1—TOTAL COST ESTIMATE FOR A RNHCI TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $72 2 $144 Director of Nursing ...... 34 5 170 Head of Maintenance ...... 26 2 52

Total ...... 9 366

After conducting a risk assessment, RNHCIs will need to review, revise, and complying with this requirement will RNHCIs will need to review, revise, and, develop new sections for their plans. require 12 burden hours for each RNHCI if necessary, develop new sections for We expect that the same individuals at a cost of $498. Therefore, for all 18 their emergency plans. The current who were involved in developing the RNHCIs to comply with these RNHCI CoPs require RNHCIs to have a risk assessment will be involved in requirements will require an estimated written disaster plan for emergencies developing the emergency preparedness 216 burden hours (12 burden hours for (§ 403.742(a)(4)). However, based on our plan. However, we expect that it will each RNHCI × 18 RNHCIs) at a cost of experience with RNHCIs, their plans require substantially more time to $8,964 ($498 estimated cost for each likely will address only evacuation from complete the plan than to complete the RNHCI × 18 RNHCIs). their facilities. We expect that all risk assessment. We estimate that

TABLE 2—TOTAL COST ESTIMATE FOR A RNHCI TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $72 3 $216 Director of Nursing ...... 34 6 204 Head of Maintenance ...... 26 3 78

Totals ...... 12 498

Under this final rule, RNHCIs will be all relevant federal, state, and local emergency preparedness policies and required to review and update their laws, regulations, and ordinances. procedures in accordance with their emergency preparedness plans at least While this requirement is subject to the emergency plan based on the emergency annually. For the purpose of PRA, we expect that complying with the plan set forth in paragraph (a), the risk determining the burden associated with requirement for an annual review of the assessment at paragraph (a)(1), and the this requirement, we will expect that emergency preparedness plan will communication plan at paragraph (c). RNHCIs already review their plans constitute a usual and customary These policies and procedures will have annually. Based on our experience with business practice as defined in the to be reviewed and updated at least Medicare providers and suppliers, implementing regulation of the PRA at annually. At a minimum, we proposed healthcare facilities have a compliance 5 CFR 1320.3(b)(2). Therefore, we have that the policies and procedures be officer or other staff member who not assigned a burden. required to address the requirements periodically reviews the facility’s Section 403.748(b) will require specified in § 403.748(b)(1) through (8). program to ensure that it complies with RNHCIs to develop and implement The RNHCIs will need to review their

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policies and procedures and compare RNHCIs, most of their emergency and compile and disseminate them to them to their emergency plan, risk preparedness policies address only the appropriate parties. We estimate that assessment, and communication plan. evacuation from the facility. it will require 6 burden hours for each Most RNHCIs will need to revise their We expect that these tasks will RNHCI to comply with this requirement existing policies and procedures or involve the administrator, the director at a cost of $234. Thus, it will require develop new policies and procedures. of nursing, and the head of 108 burden hours (6 burden hours for The current RNHCI CoPs require them maintenance. All three will need to each RNHCI × 18 RNHCIs) for all 18 to have written policies concerning their review and comment on the RNHCI’s RNHCIs to comply with the services (§ 403.738). Thus, some current policies and procedures. The requirements in § 403.748(b)(1) through RNHCIs may have some emergency director of nursing will revise or (8) at a cost of $4,212 ($234 estimated preparedness policies and procedures. develop new policies and procedures, as × However, based on our experience with needed, ensure that they are approved, cost for each RNHCI 18 RNHCIs).

TABLE 3—TOTAL COST ESTIMATE FOR A RNHCI TO DEVELOP NEW POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $72 1 $72 Director of Nursing ...... 34 4 136 Head of Maintenance ...... 26 1 26

Totals ...... 6 234

Section 403.748(c) will require burden associated with complying with and the head of maintenance. We RNHCIs to develop and maintain an this requirement will be the resources estimate that complying with this emergency preparedness required to review and, if necessary, requirement will require 4 burden hours communication plan that complies with revise an existing communication plan for each RNHCI at a cost of $166. Thus, both federal and state law and must be or develop a new plan. Based on our it will require an estimated 72 burden reviewed and updated at least annually. experience with RNHCIs, we expect that hours (4 burden hours for each RNHCI We proposed that the communication these activities will require the × 18 RNHCIs) at a cost of $2,988 ($166 plan include the information specified involvement of the RNHCI’s estimated cost for each RNHCI × 18 at § 403.748(c)(1) through (7). The administrator, the director of nursing, RNHCIs).

TABLE 4—TOTAL COST ESTIMATE FOR A RNHCI TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $72 1 $72 Director of Nursing ...... 34 2 68 Head of Maintenance ...... 26 1 26

Totals ...... 4 166

We proposed that RNHCIs will also proposing that a RNHCI meet the updated emergency preparedness plans, have to review and update their requirements specified at policies and procedures, and emergency preparedness § 403.748(d)(1) and (2). Section communication plans and revise or, if communication plan at least annually. 403.748(d)(1) will require RNHCIs to necessary, develop new sections for We believe that RNHCIs already review provide initial training in emergency their training programs. their emergency preparedness preparedness policies and procedures to We expect that complying with these communication plans periodically. all new and existing staff, individuals Thus, complying with this requirement providing services under arrangement, requirements will require the will constitute a usual and customary and volunteers, consistent with their involvement of the RNHCI administrator business practice and will not be subject expected roles, and maintain and the director of nursing. We estimate to the PRA in accordance with the documentation of the training. that it will require 7 burden hours for implementing regulation of the PRA at Thereafter, the RNHCI will have to each RNHCI to develop an emergency 5 CFR 1320.3(b)(2). Therefore, we have provide training at least annually. Based training program at a cost of $314. Thus, not assigned a burden. on our experience, all RNHCIs have it will require an estimated 126 burden Section 403.748(d) will require some type of emergency preparedness hours (7 burden hours for each RNHCI RNHCIs to develop and maintain an training program. However, all RNHCIs × 18 RNHCIs) at a cost of $5,652 ($1855 emergency preparedness training and will need to compare their current estimated cost for each RNHCI × 18 testing program that must be reviewed emergency preparedness training RNHCI). and updated at least annually. We are programs to their risk assessments and

TABLE 5—TOTAL COST ESTIMATE FOR A RNHCI TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Administrator ...... $72 2 $144

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TABLE 5—TOTAL COST ESTIMATE FOR A RNHCI TO DEVELOP A TRAINING PROGRAM—Continued

Position Hourly wage Burden hours Cost estimate

Director of Nursing ...... 34 5 170

Totals ...... 7 314

We are proposing that RNHCIs also Therefore, we have not calculated an exercise periodically to test their review and update their emergency estimate of the burden. emergency preparedness plans. preparedness training and testing Section 403.748(d)(2) will require However, we expect that RNHCIs will programs at least annually. Based on our RNHCIs to conduct a paper-based, not be fully compliant with our experience with Medicare providers and tabletop exercise at least annually. The requirements. We expect that the suppliers, healthcare facilities have a RNHCI must also analyze its response to director of nursing will develop the compliance officer or other staff member and maintain documentation of all scenarios and required documentation. who periodically reviews the facility’s tabletop exercises and emergency We estimate that these tasks will require program to ensure that it complies with events, and revise its emergency plan, as 3 burden hours at a cost of $102 for each all relevant federal, state, and local needed. RNCHI. Based on this estimate, for all laws, regulations, and ordinances. The burden associated with 18 RNHCIs to comply with these While this requirement is subject to the complying with this requirement will be requirements will require 54 burden PRA, we expect that complying with the resources RNHCIs will need to hours (3 burden hours for each RNHCI this requirement will constitute a usual develop the scenarios for the exercises × 18 RNHCIs) at a cost of $1,836 ($102 and customary business practice as and the necessary documentation. Based × defined in the implementing regulation on our experience with RNHCIs, estimated cost for each RNHCI 18 of the PRA at 5 CFR 1320.3(b)(2). RNHCIs already conduct some type of RNHCI).

TABLE 6—TOTAL COST ESTIMATE FOR A RNHCI TO CONDUCT TRAINING EXERCISES

Position Hourly wage Burden hours Cost estimate

Director of Nursing ...... $34 3 $102

Totals ...... 3 102

TABLE 7—BURDEN HOURS AND COST ESTIMATES FOR ALL 18 RNHCIS TO COMPLY WITH THE ICRS CONTAINED IN § 403.748 CONDITION: EMERGENCY PREPAREDNESS

Hourly labor Total labor OMB Number of Number of Burden per Total annual cost of cost of Total cost Regulation section(s) Control No. respondents responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 403.748(a)(1) ...... 0938–New ...... 18 18 9 162 ** 6,588 6,588 § 403.748(a)(1)–(4) ...... 0938–New ...... 18 18 12 216 ** 8,964 8,964 § 403.748(b) ...... 0938–New ...... 18 18 6 108 ** 4,212 4,212 § 403.748(c) ...... 0938–New ...... 18 18 4 72 ** 2,988 2,988 § 403.748(d)(1) ...... 0938–New ...... 18 18 7 126 ** 5,652 5,652 § 403.748(d)(2) ...... 0938–New ...... 18 18 3 54 ** 1,836 1,836

Totals ...... 18 108 ...... 738 ...... 30,240 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 7.

D. ICRs Regarding Condition for ASC to develop a documented, facility- necessary to perform a thorough risk Coverage: Emergency Preparedness based and community-based risk assessment. As of June 2016, there are (§ 416.54) assessment utilizing an all-hazards 5,485 ASCs. The current regulations Section 416.54(a) will require ASCs to approach. We expect that an ASC will covering ASCs include emergency develop and maintain an emergency consider its location and geographical preparedness requirements. preparedness plan and review and area; patient population, including A significant factor in determining the update that plan at least annually. We those with disabilities and other access burden is the accreditation status of an proposed that the plan must meet the and functional needs; and the type of ASC. Of the 5,485 ASCs, 4,071 are non- requirements contained in § 416.54(a)(1) services the ASC has the ability to accredited and 1,414 are accredited. Of through (4). provide in an emergency. The ASC also the 1,414 accredited ASCs, we estimate We will discuss the burden for these will need to identify the measures it that 491 are accredited by The Joint activities individually in this final rule must take to ensure continuity of its Commission (TJC), 731 by the AAAHC, beginning with the risk assessment operation, including delegations and and additional facilities are accredited requirement in § 416.54(a)(1). We expect succession plans. by the AOA/HFAP or the AAAASF. The that each ASC will conduct a thorough The burden associated with this accreditation standards for these risk assessment. This will require the requirement will be the time and effort organizations vary in their requirements

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related to emergency preparedness. The CAMAC Refreshed Core, January 2007, TJC-accredited ASCs (5,485 total AOA/HFAP’s standards are very similar (CAMAC), TJC Standard EC.1.10, EP 4, ASCs¥491 TJC-accredited ASCs). to the current ASC regulations. p. EC–9). In addition, ASCs must We expect that all ASCs have already AAAASF does have some emergency conduct a hazard vulnerability analysis performed at least some of the work preparedness requirements, such as (HVA) (CAMAC, Standard EC.4.10, EP needed for a risk assessment. However, requirements for responses or written 1, p. EC–12). The HVA requires the many probably have not performed a protocols for security emergencies, for identification of potential emergencies thorough risk assessment. Therefore, we example, intruders and other threats to and the effects those emergencies could expect that all non TJC-accredited ASCs staff or patients; power failures; have on the ASC’s operations and the will perform thorough reviews of their transferring patients; and emergency demand for its services (CAMAC, p. EC– current risk assessments, if they have evacuation of the facility. However, the 12). We expect that TJC-accredited ASCs them, and revise them to ensure they accreditation standards for both the already conduct a risk assessment that have updated the assessments and that AOA/HFAP and AAAASF will not complies with these requirements. If they have included all of the significantly satisfy the ICRs contained there are any tasks these ASCs need to requirements in § 416.54(a). in this final rule. Therefore, for the complete to satisfy the requirement for We have not designated any specific purpose of determining the burden a risk assessment, we expect that the process or format for ASCs to use in imposed on ASCs by this final rule, we burden imposed by this requirement conducting their risk assessments will include the ASCs that are will be negligible. For the 491 TJC- because we believe that ASCs, as well accredited by both the AOA/HFAP and accredited ASCs, the risk assessment as other healthcare providers and AAAASF with the non-accredited ASCs. requirement will constitute a usual and TJC and AAAHC’s accreditation suppliers, need maximum flexibility in customary business practice. While this determining the best way for their standards contain more extensive requirement is subject to the PRA, we emergency preparedness requirements facilities to accomplish this task. expect that complying with this However, we expect healthcare facilities than the accreditation standards of requirement will constitute a usual and either AOA/HFAP or AAAASF. For to, at a minimum; include input from all customary business practice as defined of their major departments in the example, TJC standards contain in the implementing regulations of the requirements for risk assessments and process of developing their risk PRA at 5 CFR 1320.3(b)(2). Therefore, assessments. Based on our experience an emergency management plan. we have not estimated the amount of AAAHC’s standards include working with ASCs, we expect that regulatory burden For ASCs with conducting the risk assessment will requirements for both internal and accreditation from TJC. external emergencies and drills for the require the involvement of an facility’s internal emergency plan. For the purpose of determining the administrator and a registered nurse. We Therefore, in discussing the individual burden for the 731 AAAHC-accredited expect that to comply with the burden requirements in this final rule, ASCs, we used the Accreditation requirements of this section, both of we will discuss the burden for the Handbook for Ambulatory Health Care these individuals will need to attend an estimated 1,222 accredited ASCs by 2008 (AHAHC). The AAAHC standards initial meeting, review the current either the AAAHC or TJC (731 AAAHC- do not contain a specific requirement assessment, prepare their comments, accredited ASCs + 491 TJC-accredited for the ASC to perform a risk attend a follow-up meeting, perform a ASCs) separately from the remaining assessment. However, in discussing the final review, and approve the risk 4,263 (ASCs that are not accredited by requirement for drills, the AAAHC notes assessment. In addition, we expect that an accrediting organization or that such drills should be appropriate to the quality improvement nurse will accredited by the AOA/HFAP and the facility’s activities and environment coordinate the meetings; perform an AAAASF). For some requirements, only (AHAHC, Accreditation Association for initial review of the current risk the TJC accreditation standards are Ambulatory Health Care, Inc., Core assessment; provide suggestions or a significantly like those in the final rule. Standards, Chapter 8. Facilities and critique of the risk assessment; For those requirements, we will analyze Environment, Element E, p. 37). coordinate comments; revise the the 491 TJC-accredited ASCs separately Therefore, we expect that in fulfilling original risk assessment; develop any from the 4,994 non TJC-accredited ASCs this core standard that the 731 AAAHC- necessary sections for the risk (5,485 ASCs¥491 TJC-accredited accredited ASCs have performed some assessment; and ensure that the ASCs). type of risk assessment. However, we do appropriate parties approve the new risk For the purpose of determining the not expect that this will satisfy the assessment. We estimate that complying burden for the TJC-accredited ASCs, we requirement for a facility-based and with this risk assessment requirement used TJC’s Comprehensive community-based risk assessment that will require 8 burden hours for each Accreditation Manual for Ambulatory addresses the elements include in the ASC at a cost of $763. Based on that Care: The Official Handbook 2008 AAAHC-accreditation for ASCs. estimate, it will require 39,952 burden (CAMAC). Concerning the requirement Therefore, the 731 AAAHC-accredited hours (8 burden hours for each ASC × for a risk assessment in § 416.54(a)(1), in ASCs will be included in the burden 4,994 non TJC-accredited ASCs) for all the chapter entitled ‘‘Management of the analysis with the ASCs that are non- non TJC-accredited ASCs to comply Environment of Care’’ (EC), ASCs are accredited or are accredited by AOA/ with this risk assessment requirement at required to conduct comprehensive, HFAP and AAAASF for the risk a cost of $3,810,422 ($763 estimated proactive risk assessments (CAMAC, assessment requirement for 4,994 non cost for each ASC × 4,994 ASCs).

TABLE 8—TOTAL COST ESTIMATE FOR A NON-TJC ACCREDITED ASC TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $110 5 $550 Registered Nurse—Quality Improvement ...... 71 3 213

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TABLE 8—TOTAL COST ESTIMATE FOR A NON-TJC ACCREDITED ASC TO CONDUCT A RISK ASSESSMENT—Continued

Position Hourly wage Burden hours Cost estimate

Total ...... 8 763

After conducting the risk assessment, AAAHC-accredited ASCs are required for the appropriate initiation and ASCs will be required to develop and to have a ‘‘comprehensive emergency management of their emergency maintain emergency preparedness plans plan to address internal and external preparedness plans. in accordance with § 416.54(a)(1) emergencies’’ (AHAC, Chapter 8. The burden associated with this through (4). All TJC-accredited ASCs Facilities and Environment, Element D, requirement will be the time and effort must already comply with many of the p. 37). However, we do not believe that necessary to develop an emergency requirements in § 416.54(a). All TJC- this requirement ensures compliance preparedness plan that complies with accredited ASCs are already required to with all of the requirements for an all of the requirements in § 416.54(a)(1) develop and maintain a ‘‘written emergency plan. We will include the through (4). Based upon our experience emergency management plan describing 731 AAAHC-accredited ASCs in the with ASCs, we expect that the the process for disaster readiness and burden analysis for this requirement. administrator and the quality emergency management’’ (CAMAC, We expect that the 4,994 non TJC- improvement nurse who will be Standard EC.4.10, EP 3, EC–13). We accredited ASCs have developed some involved in the risk assessment will also expect that the TJC-accredited ASCs type of emergency preparedness plan. be involved in developing the already have emergency preparedness However, under this final rule, all of emergency preparedness plan. We plans that comply with these these ASCs will have to review their estimate that complying with this requirements. If there are any activities current plans and compare them to the requirement will require 11 burden required to comply with these risk assessments they performed in hours for each ASC at a cost of $937. requirements, we expect that the burden accordance with § 416.54(a)(1). The Therefore, based on that estimate, for will be negligible. Thus, for 491 TJC- ASCs will then need to update, revise, the 4,994 non TJC-accredited ASCs to accredited ASCs, this requirement will and in some cases, develop new comply with the requirements in this constitute a usual and customary sections to ensure that their plans section will require 54,934 burden business practice for these ASCs in incorporate their risk assessments and hours (11 burden hours for each non accordance with the implementing address all of the requirements. The TJC-accredited ASC × 4,994 non TJC- regulations of the PRA at 5 CFR ASC will also need to review, revise, accredited ASCs) at a cost of $4,679,378 1320.3(b)(2). Therefore, we will not and, in some cases, develop the ($937 estimated cost for each non TJC- include this activity in the burden delegations of authority and succession accredited ASC × 4,994 non TJC- analysis for those ASCs. plans that ASCs determine are necessary accredited ASCs).

TABLE 9—TOTAL COST ESTIMATE FOR A NON-TJC ACCREDITED ASC TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $110 4 $440 Registered Nurse-Quality Improvement ...... 71 7 497

Total ...... 11 937

All of the ASCs will also be required 1320.3(b)(2). Therefore, we will not will need to thoroughly review their to review and update their emergency include this activity in the burden emergency preparedness policies and preparedness plans at least annually. analysis. procedures and compare them to all of For the purpose of determining the Section 416.54(b) proposed that each the information previously noted. The burden for this requirement, we will ASC be required to develop and ASCs will then need to revise, or in expect that ASCs will review their plans implement emergency preparedness some cases, develop new policies and annually. All ASCs have a professional policies and procedures, based on the procedures that will ensure that the staff person, a quality improvement emergency plan set forth in paragraph ASCs’ emergency preparedness plans (a), the risk assessment at paragraph nurse, whose responsibility entails address the specific elements. (a)(1), and the communication plan set TJC accreditation standards already ensuring that the ASC is delivering forth in paragraph (c). We will require require many of the specific elements quality patient care and that the ASC is ASCs to review and update these that are required in this section. For complying with regulations concerning policies and procedures at least example, in the chapter entitled patient care. We expect that the quality annually. These policies and procedures ‘‘Leadership’’ (LD), TJC-accredited ASCs improvement nurse will be primarily will be required to include, at a are required to ‘‘develop policies and responsible for the annual review of the minimum, the requirements listed at procedures that guide and support ASC’s emergency preparedness plan. § 416.54(b)(1) through (7). We expect patient care, treatment, and services’’ We expect that complying with this that ASCs will develop emergency (CAMAC, Standard LD.3.90, EP 1, p. requirement will constitute a usual and preparedness policies and procedures LD–12a). In addition, TJC-accredited customary business practice for ASCs in based upon their risk assessments, ASCs must already address or perform accordance with the implementing emergency preparedness plans, and a HVA; processes for communicating regulations of the PRA at 5 CFR communication plans. Therefore, ASCs with and assigning staff under

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emergency conditions; provision of include this activity in the burden policies and procedures and revise their subsistence or critical needs; evacuation analysis for these 491 TJC-accredited policies and procedures to ensure that of the facility; and alternate sources for ASCs. they address all of the requirements. We fuel, water, electricity, etc. (CAMAC, AAAHC standards require ASCs to expect that the quality improvement Standard EC.4.10, EPs 1, 7–10, 12, and have ‘‘the necessary personnel, nurse will initially review the ASC’s 20, pp. EC–12–13). They must also equipment and procedures to handle emergency preparedness policies and critique their drills and modify their medical and other emergencies that may procedures. The quality improvement emergency management plans in arise in connection with services sought nurse will send any recommendations response to the critiques (CAMAC, or provided’’ (AHAHC, Chapter 8. for changes or additional policies or Facilities and Environment, Element B, Standard EC.4.20, EPs 12–16, pp. EC– procedures to the ASC’s administrator. 14–14a). In the chapter entitled, p. 37). Although, we expect that The administrator and quality ‘‘Management of Information’’ (IM), they AAAHC-accredited ASCs probably improvement nurse will need to make are required to protect and preserve the already have policies and procedures privacy and confidentiality of sensitive that address at least some of the the necessary revisions and draft any data (CAMAC, Standard IM.2.10, EPs 1 requirements, we expect that they will necessary policies and procedures. We and 9, p. IM–6). If TJC-accredited ASCs sustain a considerable burden in estimate that for each non TJC- have any tasks required to satisfy these satisfying all of the requirements. We accredited ASC to comply with this requirements, we expect they will will include the AAAHC-accredited requirement will require 9 burden hours constitute only a negligible burden. For ASCs with the non-accredited ASCs in at a cost of $717. For the 4,994 ASCs to the 491 TJC-accredited ASCs, the determining the burden for the comply with this requirement, it will requirement for emergency requirements in § 416.54(b). require an estimated 44,946 burden preparedness policies and procedures We expect that all of the 4,994 non hours (9 burden hours for each non TJC- will constitute a usual and customary TJC-accredited ASCs have some accredited ASC × 4,994 non TJC- business practice in accordance with the emergency preparedness policies and accredited ASCs) at a cost of $3,580,698. implementing regulations of the PRA 5 procedures. However, we expect that all ($717 estimated cost for each non TJC- CFR 1320.3(b)(2). Therefore, we will not of these ASCs will need to review their accredited ASC × 4,994 ASCs).

TABLE 10—TOTAL COST ESTIMATE FOR A NON-TJC ACCREDITED ASC TO DEVELOP NEW POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $110 2 $220 Registered Nurse-Quality Improvement ...... 71 7 497

Total ...... 9 717

Section 416.54(c) will require each necessary to satisfy the requirements, in determining the burden for these ASC to develop and maintain an we expect the revisions or additions requirements for a total of 4,994 non emergency preparedness will be those incurred during the course TJC-accredited ASCs (5,485 total communication plan that complies with of normal business and thereby impose ASCs¥491 TJC accredited ASCs). both federal and state law. We also no additional burden. Thus, for the TJC- We expect that all non TJC-accredited proposed that ASCs will have to review accredited ASCs, the requirements for ASCs currently have some type of and update these plans at least the emergency preparedness emergency preparedness annually. These communication plans communication plan will constitute a communication plan. It is standard will have to include the information usual and customary business practice practice in the healthcare industry to listed in § 416.54(c)(1) through (7). The for ASCs as stated in the implementing have and maintain contact information burden associated with developing and regulations of the PRA at 5 CFR for both staff and outside sources of maintaining an emergency preparedness 1320.3(b)(2). Thus, we will not include assistance; alternate means of communication plan will be the time this activity by these TJC-accredited communications in case there is an and effort necessary to review, revise, ASCs in the burden analysis. interruption in phone service to the and, if necessary, develop new sections The AAAHC standards do not have a facility, such as cell phones; and a for the ASC’s emergency preparedness specific requirement for a method for sharing information and communications plan to ensure that it communication plan for emergencies. medical documentation with other satisfied these requirements. However, AAAHC-accredited ASCs are healthcare providers to ensure TJC-accredited ASCs are required to required to have the ‘‘necessary continuity of care for their patients. We have a plan that ‘‘identifies backup personnel, equipment and procedures to expect that all ASCs already satisfy the internal and external communication handle medical and other emergencies requirements in § 416.54(c)(1) through systems in the event of failure during that may arise in connection with (4). However, for the requirements in emergencies’’ (CAMAC, Standard services sought or provided (AAAHC, 8. § 416.54(c)(5) through (7), all ASCs will EC.4.10, EP 18, p. EC–13). There are also Facilities and Environment, Element B, need to review, revise, and, if necessary, requirements for identifying, notifying, p. 37) and ‘‘a comprehensive emergency develop new sections for their plans to and assigning staff, as well as notifying plan to address internal and external ensure that they include all of the external authorities (CAMAC, Standard emergencies’’ (AAAHC, 8. Facilities and requirements. We expect that this will EC.4.10, EPs 7–9, p. EC–13). In addition, Environment, Element D, p. 37). Since require the involvement of the ASC’s the facility’s plan must provide for AAAHC does have a specific administrator and a registered nurse. We controlling information about patients requirement for a communication plan, estimate that complying with this (CAMAC, Standard EC.4.10, EP 10, p. we will include the AAAHC-accredited requirement will require 4 burden hours EC–13). If any revisions or additions are ASCs in with the non-accredited ASCs at a cost of $323. Therefore, for all non

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TJC-accredited ASCs to comply with the hours for each non TJC-accredited ASC for each non TJC-accredited ASC × requirements in this section will require × 4,994 non TJC-accredited ASCs) at a 4,994 non TJC-accredited ASCs). an estimated 19,976 burden hours (4 cost of $1,613,062 ($323 estimated cost

TABLE 11—TOTAL COST ESTIMATE FOR A NON-TJC ACCREDITED ASC TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $110 1 $110 Registered Nurse-Quality Improvement ...... 71 3 213

Total ...... 4 323

We also proposed that ASCs must under arrangement, and volunteers, expect that all of the AAAHC-accredited review and update their emergency consistent with their expected roles, and ASCs already are providing some preparedness communication plans at maintain documentation of the training. training on their emergency least annually. We believe that ASCs ASCs will have to ensure that their staff preparedness policies and procedures. already review their emergency can demonstrate knowledge of However, this requirement does not preparedness communication plans emergency procedures. Thereafter, ASCs include any requirement for annual periodically. Therefore, we believe will have to provide the training at least training or for any training for staff that complying with this requirement will annually. TJC-accredited ASCs must are not healthcare professionals. This constitute a usual and customary provide an initial orientation to their AAAHC-accredited requirement does business practice for ASCs as stated in staff and independent practitioners not ensure that these ASCs are already the implementing regulations of the (CAMAC, Standard 2.10, HR–8). They complying with the requirements. PRA at 5 CFR 1320.3(b)(2). must also provide ‘‘on-going education, Therefore, we will include these Section 416.54(d) will require ASCs to including in-services, training, and AAAHC-accredited ASCs in develop and maintain emergency other activities’’ to maintain and determining the information collection preparedness training and testing improve staff competence (CAMAC, burden for these requirements. programs that ASCs must review and Standard 2.30, HR–9). We expect that Based upon our experience with update at least annually. Specifically, these TJC-accredited ASCs include some ASCs must meet the requirements listed ASCs, we expect that all 5,485 ASCs training on their facilities’ emergency have some type of emergency at § 416.54(d)(1) and (2). preparedness policies and procedures in The burden associated with preparedness training program. We also their current training programs. expect that these ASCs will need to complying with these requirements will However, these requirements do not be the time and effort necessary for an review their training programs and contain any requirements for training ASC to review, update, and, in some compare them to their risk assessments, volunteers. Thus, TJC accreditation cases, develop new sections for its emergency preparedness plans, policies standards do not ensure that TJC- emergency preparedness training and procedures, and communication accredited ASCs are already fulfilling all program. Since ASCs are currently plans. The ASCs will then need to make of the requirements, and we expect that required to conduct drills, at least any necessary revisions to their training the TJC-accredited ASCs will incur a annually, to test their disaster plan’s programs to ensure they comply with burden complying with these effectiveness, we expect that all ASCs these requirements. We expect that requirements. Therefore, we will already provide training on their complying with this requirement will include these TJC-accredited ASCs in emergency preparedness policies and require the involvement of an procedures. However, all ASCs will determining the burden for these administrator and a quality need to review their current training requirements. improvement nurse. We estimate that and testing programs and compare their The AAAHC-accredited ASCs are for each ASC to develop a contents to their risk assessments, already required to ensure that ‘‘all comprehensive emergency training emergency preparedness plans, policies health care professionals have the program will require 6 burden hours at and procedures, and communication necessary and appropriate training and a cost of $465. Therefore, the estimated plans. skills to deliver the services provided by annual burden for all 5,485 ASCs to Section 416.54(d)(1) will require the organization’’ (AAAHC, Chapter 4. comply with these requirements is ASCs to provide initial training in their Quality of Care Provided, Element A, p. 32,910 burden hours (6 burden hours × emergency preparedness policies and 28). Since these ASCs are required to 5,4855 ASCs) at an estimated cost of procedures to all new and existing staff, have an emergency plan that addresses $2,550,525 ($465 estimated cost for each individuals providing on-site services internal and external emergencies, we ASC × 5,485 ASCs).

TABLE 12—TOTAL COST ESTIMATE FOR AN ASC TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Administrator ...... $110 1 $110 Registered Nurse-Quality Improvement ...... 71 5 355

Total ...... 6 465

We proposed that ASCs will also have preparedness training programs at least determining the burden for this to review and update their emergency annually. For the purpose of requirement, we will expect that ASCs

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will review their emergency a scenario for each drill and exercise. a community-based drill; or for the preparedness training program ASCs will also need to develop the ASCs to maintain documentation of annually. We expect that all ASCs have documentation necessary for recording their testing exercises or emergency a quality improvement nurse what happened during the testing events. This AAAHC accreditation responsible for ensuring that the ASC is exercises and emergency events and requirement does not ensure that delivering quality patient care and that analyze their responses to these events. AAAHC-accredited ASCs are already the ASC is complying with patient care TJC-accredited ASCs are required to complying with these requirements. regulations. We expect that a registered regularly test their emergency Therefore, the AAAHC-accredited ASCs nurse will be primarily responsible for management plans at least twice a year, will be included in the burden estimate. the annual review of the ASC’s critique each exercise, and modify their Based on our experience with ASCs, emergency preparedness training emergency management plans in we expect that all of the 5,485 ASCs will program. Thus, in accordance with the response to those critiques (CAMAC, be required to develop scenarios for implementing regulations of the PRA at Standard EC.4.20, EP 1 and 12–16, p. their testing exercises and the 5 CFR 1320.3(b)(2), we believe EC–14–14a). In addition, the scenarios documentation necessary to record and complying with this requirement will for these drills should be realistic and analyze these events, as well as any constitute a usual and customary related to the priority emergencies the emergency events. Although we believe business practice for ASCs. Thus, we ASC identified in its HVA (CAMAC, many ASCs may have developed will not include this activity in this Standard EC.4.20, EP 5, p. EC–14). scenarios and documentation for burden analysis. However, the EPs for this standard do whatever type of drills or exercises they Section 416.54(d)(2) will require not contain any requirements for the had previously performed, we expect all ASCs to participate in a full-scale drills to be community-based; for there ASCs will need to ensure that the exercise at least annually. ASCs will to be a paper-based, tabletop exercise; or testing of their emergency preparedness also have to participate in one for the ASCs to maintain documentation plans comply with these requirements. additional testing exercise of their of these testing exercises or emergency Based upon our experience with ASCs, choice at least annually. If the ASC events. These TJC accreditation we expect that complying with this experiences an actual natural or man- requirements do not ensure that TJC- requirement will require the made emergency that requires activation accredited ASCs are already complying involvement of an administrator and a of their emergency plan, the ASC will be with these requirements. Therefore, the registered nurse. We estimate that for exempt from the requirement for a full- TJC-accredited ASCs will be included in each ASC to comply will require 5 scale exercise for 1 year following the the burden estimate. burden hours at a cost of $394. onset of the actual event. ASCs will also The AAAHC-accredited ASCs already Therefore, for all 5,485 ASCs to comply be required to analyze their response to are required to perform at least four with this requirement will require an and maintain documentation of all drills annually of their internal estimated 27,425 burden hours (5 drills, tabletop exercises, and emergency emergency plans (AAAHC, Chapter 8. burden hours for each ASC × 5,485 events, and revise their emergency Facilities and Environment, Element E, ASCs) at a cost of $2,161,090 ($394 plans, as needed. To comply with this p. 37). However, there is no requirement estimated cost for each ASC × 5,485 requirement, ASCs will need to develop for a paper-based, tabletop exercise; for ASCs).

TABLE 13—TOTAL COST ESTIMATE FOR AN ASC TO CONDUCT TRAINING EXERCISES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $110 1 $110 Registered Nurse-Quality Improvement ...... 71 4 284

Total ...... 5 394

TABLE 14—BURDEN HOURS AND COST ESTIMATES FOR ALL 5,485 ASCS TO COMPLY WITH THE ICRS CONTAINED IN § 416.54 CONDITION: EMERGENCY PREPAREDNESS

Hourly labor Total labor OMB Burden per Total annual cost of cost of Total cost Regulation section(s) Control No. Respondents Responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 416.54(a)(1) ...... 0938–New ...... 4,994 4,994 8 39,952 ** 3,810,422 3,810,422 § 416.54(a)(1)–(4) ...... 0938–New ...... 4,994 4,994 11 54,934 ** 4,679,378 4,679,378 § 416.54(b) ...... 0938–New ...... 4,994 4,994 9 44,946 ** 3,580,698 3,580,698 § 416.54(c) ...... 0938–New ...... 4,994 4,994 4 19,976 ** 1,613,062 1,613,062 § 416.54(d)(1) ...... 0938–New ...... 5,485 5,485 6 32,910 ** 2,550,525 2,550,525 § 416.54(d)(2) ...... 0938–New ...... 5,485 5,485 5 27,425 ** 2,161,090 2,161,090

Totals ...... 10,479 30,946 ...... 220,143 ...... 18,395,175.00 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 14.

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E. ICRs Regarding Condition of referring to hospices that only provide current Hospice CoPs require every Participation: Emergency Preparedness in-home care, and contract with other hospice to have an IDG that includes a (§ 418.113) facilities to provide inpatient care. The physician, registered nurse, social Section 418.113(a) will require current requirements for hospices worker, and pastoral or other counselor. hospices to develop and maintain an contain emergency preparedness The responsibilities of one of a emergency preparedness plan that must requirements for inpatient hospices only hospice’s IDGs, if they have more than be reviewed and updated at least (§ 418.110). Inpatient hospices must one, include the establishment of annually. We proposed that the plan have ‘‘a written disaster preparedness ‘‘policies governing the day-to-day meet the criteria listed in § 418.113(a)(1) plan in effect for managing the provision of hospice care and services’’ through (4). consequences of power failures, natural (§ 418.56(a)(2)). Thus, we believe the Although § 418.113(a) is entitled disasters, and other emergencies that IDG will be involved in performing the ‘‘Emergency Plan’’ and the requirement will affect the hospice’s ability to risk assessment. for the plan is stated first, the provide care,’’ as stated in § 418.110(c)(1)(ii). Thus, we expect We expect that members of the IDG emergency plan must include and be will attend an initial meeting; review based upon a risk assessment. inpatient hospices already have performed some type of risk assessment any existing risk assessment; develop Therefore, since hospices must perform comments and recommendations for their risk assessments before beginning, during the process of developing their changes to the assessment; attend a or at least before they complete, their disaster preparedness plan. However, follow-up meeting; perform a final plans, we will discuss the burden these risk assessments may not be review; and approve the risk related to performing the risk documented or may not address all of assessment. We expect that the assessment first. the requirements under § 418.113(a). Section 418.113(a)(1) will require all Therefore, we believe that all inpatient administrator will coordinate the hospices to develop a documented, hospices will have to conduct a meetings, perform an initial review of facility-based and community-based risk thorough review of their current risk the current risk assessment, provide a assessment utilizing an all-hazards assessments and then perform the critique of the risk assessment, offer approach. We expect that in performing necessary tasks to ensure that their suggested revisions, coordinate a risk assessment, a hospice will need facilities’ risk assessments comply with comments, develop the new risk to consider its physical location, the these requirements. assessment, and ensure that the geographic area in which it is located, We have not designated any specific necessary staff approves the new risk and its patient population. process or format for hospices to use in assessment. We believe it is likely that The burden associated with this conducting their risk assessments the administrator will spend more time requirement will be the time and effort because we believe hospices need reviewing and working on the risk necessary to perform a thorough risk maximum flexibility in determining the assessment than the other individuals in assessment. There are 4,401 hospices. best way for their facilities to the IDG. We estimate it will require 10 There are 3,989 hospices that provide accomplish this task. However, we burden hours to review and update the care only to patients in their homes believe that in the process of developing risk assessment at a cost of $759. There (home health based and freestanding a risk assessment, healthcare are 412 inpatient hospices. Therefore, hospices) and 412 hospices that offer institutions should include based on that estimates, it will require inpatient care directly (hospital, SNF, representatives from or obtain input 4,120 burden hours (10 burden hours for and NF based hospices). When we use from all of their major departments. each inpatient hospice × 412 inpatient the term ‘‘inpatient hospice,’’ we are Based on our experience with hospices, hospices) for all inpatient hospices to referring to a hospice that operates its we expect that conducting the risk comply with this requirement at a cost own inpatient care facility; that is, the assessment will require the involvement of $312,708 ($759 estimated cost for hospice provides the inpatient care of the hospice’s administrator and an each inpatient hospice × 412 inpatient itself. By ‘‘outpatient hospices’’, we are interdisciplinary group (IDG). The hospices).

TABLE 15—TOTAL COST ESTIMATE FOR AN INPATIENT HOSPICE TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $80 4 $320 Physician ...... 180 1 180 Counselor ...... 34 1 34 Social Worker ...... 45 1 45 Registered Nurse ...... 60 3 180

Totals ...... 10 759

There are no emergency preparedness they might experience, we anticipate their homes, it will require 47,868 requirements in the current hospice that these facilities will require more burden hours (12 burden hours for each CoPs for hospices that provide care to time than an inpatient hospice to hospice × 3,989 hospices) to comply patients in their homes. However, it is perform a risk assessment. We estimate with this requirement at a cost of standard practice for healthcare that each hospice that provides care to $3,586,111 ($899 estimated cost for each facilities to plan and prepare for patients in their homes will require 12 hospice × 3,989 hospices). Based on the common emergencies, such as fires, burden hours to develop its risk previous calculations, we estimate that power outages, and storms. Although assessment at a cost of $899. Therefore, for all 4,401 hospices to develop a risk we expect that these hospices have based on that estimate, for all 3,989 assessment will require 51,988 burden considered at least some of the risks hospices that provide care to patients in hours at a cost of $3,898,819.

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TABLE 16—TOTAL COST ESTIMATE FOR AN OUTPATIENT HOSPICE TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $80 5 $400 Physician ...... 180 1 180 Counselor ...... 34 1 34 Social Worker ...... 45 1 45 Registered Nurse ...... 60 4 240

Totals ...... 12 899

After conducting the risk assessments, addressing likely emergency events or relevant sections of the facility’s current hospices will have to develop and address their patient population; the emergency preparedness or disaster maintain emergency preparedness plans type of services they have the ability to plan(s), develop comments and that they will have to review and update provide in an emergency; or continuity recommendations for changes to the at least annually. We expect all hospices of operations, including delegations of facility’s plan, attend a follow-up to compare their current emergency authority and succession plans. We meeting, perform a final review, and plans, if they have them, to the risk expect that an inpatient hospice will approve the emergency plan. We expect assessments they performed in have to review its current plan and that the administrator will probably accordance with § 418.113(a)(1). In compare it to its risk assessment, as well coordinate the meetings, perform an addition, hospices will have to comply as to the other requirements we initial review of the current emergency with the requirements in § 418.113(a)(1) proposed. We expect that most inpatient plan, provide a critique of the through (4). They will then need to hospices will need to update and revise emergency plan, offer suggested review, revise, and, if necessary, their existing emergency plans, and, in revisions, coordinate comments, develop new sections of their plans to some cases, develop new sections to develop the new emergency plan, and ensure they comply with these comply with our requirements. ensure that the necessary parties The burden associated with this requirements. approve the new emergency plan. We requirement will be the time and effort The current hospice CoPs require necessary to develop an emergency expect the administrator will probably inpatient hospices to have ‘‘a written preparedness plan or to review, revise, spend more time reviewing and working disaster preparedness plan in effect for and develop new sections for an on the emergency plan than the other managing the consequences of power existing emergency plan. Based upon individuals. We estimate that it will failures, natural disasters, and other our experience with inpatient hospices, require 14 burden hours for each emergencies that will affect the we expect that these activities will inpatient hospice to develop its hospice’s ability to provide care’’ require the involvement of the hospice’s emergency preparedness plan at a cost (§ 418.110(c)(1)(ii)). We believe that all administrator and an IDG, that is, a of $1,159. Based on this estimate, it will inpatient hospices already have some physician, registered nurse, social require 5,768 burden hours (14 burden type of emergency preparedness or worker, and counselor. We believe that hours for each inpatient hospice × 412 disaster plan. However, their plans may developing the plan will require more inpatient hospices) for all inpatient not address all likely medical and non- time to complete than the risk hospices to complete their plans at a medical emergency events identified by assessment. cost of $477,508 ($1,159 estimated cost the risk assessment. Furthermore, their We expect that these individuals will for each inpatient hospice × 412 plans may not include strategies for have to attend an initial meeting, review inpatient hospices).

TABLE 17—TOTAL COST ESTIMATE FOR AN INPATIENT HOSPICE TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $80 6 $480 Physician ...... 180 2 360 Counselor ...... 34 1 34 Social Worker ...... 45 1 45 Registered Nurse ...... 60 4 240

Totals ...... 14 1,159

As discussed earlier, we have no plan, each hospice will need to review patients in their homes have emergency current regulatory requirement for its emergency plan to ensure that it plans, we believe it will require more hospices that provide care to patients in addressed the risks identified in its risk time for each of these hospices than for their homes to have emergency assessment and complied with the inpatient hospices to complete an preparedness plans. However, it is requirements. We expect that an emergency plan. We estimate that for standard practice for healthcare administrator and the individuals from each hospice that provides care to providers to plan for common the hospice’s IDG will be involved in patients in their homes to comply with emergencies, such as fires, power reviewing, revising, and developing a this requirement will require 20 burden outages, and storms. Although we facility’s emergency plan. However, hours at an estimated cost of $1,599. expect that these hospices already have since there are no current requirements Based on that estimate, for all 3,989 of some type of emergency or disaster for hospices that provide care to these hospices to comply with this

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requirement will require 79,780 burden ($1,599 estimated cost for each hospice emergency preparedness plan will hours (20 burden hours for each hospice × 3,989 hospices). We estimate that for require 6,378,411 burden hours at a cost × 3,989 hospices) at a cost of $6,378,411 all 4,401 hospices to develop an of $6,855,919.

TABLE 18—TOTAL COST ESTIMATE FOR AN OUTPATIENT HOSPICE TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $80 10 $800 Physician ...... 180 2 360 Counselor ...... 34 1 34 Social Worker ...... 45 1 45 Registered Nurse ...... 60 6 360

Totals ...... 20 1,599

Hospices will also be required to Outpatient hospices, either home administrator, physician, counselor, review and update their emergency based or freestanding, on the other social worker, and registered nurse. We preparedness plans at least annually. hand, currently do not have emergency estimate that for each hospice that The current hospice CoPs require preparedness requirements in the provides care to patients in an inpatient hospices to periodically current hospice CoPs and as such, there outpatient setting to comply with this review and rehearse their disaster is no requirement for an annual review requirement will require 8 burden hours preparedness plan with their staff, of the plan. Therefore, we will analyze at an estimated cost of $619. Based on including non-employee staff (42 CFR the burden from this requirement for that estimate, for all 3,989 of these 418.110(c)(1)(ii)). For purposes of this outpatient hospices. hospices to comply with this burden estimate, we will expect that Based on our experience with requirement will require 31,912 burden under this final rule, inpatient hospices outpatient hospices, we expect that the hours (8 burden hours for each hospice will review their emergency plans prior same individuals who develop the × 3,989 hospices) at a cost of $2,469,191 to reviewing them with all of their emergency preparedness plan will × employees and that this review will annually review and update the plan. ($619 estimated cost for each hospice occur annually. These staff would include the 3,989 hospices).

TABLE 19—TOTAL COST ESTIMATE FOR AN OUTPATIENT HOSPICE TO REVIEW AND UPDATE AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $80 3 $240 Physician ...... 180 1 180 Counselor ...... 34 1 34 Social Worker ...... 45 1 45 Registered Nurse ...... 60 2 120

Totals ...... 8 619

We expect that all hospices, both Section 418.113(b) will require each (§ 418.110(c)(1)(ii)). In addition, the inpatient and those that provide care to hospice to develop and implement responsibilities for at least one of a patients in their homes, have an emergency preparedness policies and hospice’s IDGs, if they have more than administrator who is responsible for the procedures, based on the emergency one, include the establishment of day-to-day operation of the hospice. plan set forth in paragraph (a), the risk ‘‘policies governing the day-to-day Day-to-day operations will include assessment at paragraph (a)(1), and the provision of hospice care and services’’ ensuring that all of the hospice’s plans communication plan at paragraph (c). It (§ 418.56(a)(2)). However, we also are up-to-date and in compliance with will also require hospices to review and expect that all inpatient hospices will relevant federal, state, and local laws, update these policies and procedures at need to review their current policies regulations, and ordinances. In addition, least annually. At a minimum, the and procedures, assess whether they it is standard practice in healthcare hospice’s policies and procedures will contain everything required by their organizations to have a professional be required to address the requirements facilities’ emergency preparedness listed at § 418.113(b)(1) through (6). plans, and revise and update them as employee, an administrator, who We expect that all hospices have some necessary. periodically reviews their plans and emergency preparedness policies and The burden associated with procedures. We expect that complying procedures because the current hospice reviewing, revising, and updating a with this requirement will constitute a CoPs for inpatient hospices already hospice’s emergency policies and usual and customary business practice require them to have ‘‘a written disaster procedures will be the resources needed and will not be subject to the PRA in preparedness plan in effect for to ensure they comply with these accordance with the implementing managing the consequences of power requirements. Since at least one of a regulations of the PRA at 5 CFR failures, natural disasters, and other hospice’s IDGs will be responsible for 1320.3(b)(2). Thus, we will not include emergencies that will affect the developing policies that govern the this activity in the burden analysis. hospice’s ability to provide care’’ daily care and services for hospice

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patients (42 CFR 418.56(a)(2)), we inpatient hospice’s compliance with hours (8 burden hours for each inpatient expect that an IDG will be involved with this requirement will require 8 burden hospice × 412 inpatient hospices) at a reviewing and revising a hospice’s hours at a cost of $619. Therefore, based cost of $255,028 ($619 estimated cost for existing policies and procedures and on that estimate, all 412 inpatient each inpatient hospice × 412 inpatient developing any necessary new policies hospices’ compliance with this hospices). and procedures. We estimate that an requirement will require 3,296 burden

TABLE 20—TOTAL COST ESTIMATE FOR AN INPATIENT HOSPICE TO DEVELOP NEW POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $80 3 $240 Physician ...... 180 1 180 Counselor ...... 34 1 34 Social Worker ...... 45 1 45 Registered Nurse ...... 60 2 120

Totals ...... 8 619

Although there are no existing final rule, the IDG for these hospices patients in their homes to comply with regulatory requirements for hospices will need to accomplish the same tasks this requirement will require 35,901 that provide care to patients in their as described earlier for inpatient burden hours (9 burden hours for each homes to have emergency preparedness hospices to ensure that these policies hospice × 3,989 hospices) at a cost of policies and procedures, it is standard and procedures comply with the $2,788,311 ($699 estimated cost for each practice for healthcare organizations to requirements. hospice × 3,989 hospices). prepare for common emergencies, such We estimate that each hospice’s Thus, we estimate that development as fires, power outages, and storms. We compliance with this requirement will of emergency preparedness policies and expect that these hospices already have require 9 burden hours at a cost of $699. procedures for all 4,401 hospices will some emergency preparedness policies Therefore, based on that estimate, all require 39,197 burden hours at a cost of and procedures. However, under this 3,989 hospices that provide care to $3,043,339.

TABLE 21—TOTAL COST ESTIMATE FOR AN OUTPATIENT HOSPICE TO DEVELOP NEW POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $80 4 $320 Physician ...... 180 1 180 Counselor ...... 34 1 34 Social Worker ...... 45 1 45 Registered Nurse ...... 60 2 120

Totals ...... 9 699

Section 418.113(c) will require a outside sources of assistance; alternate The burden associated with hospice to develop and maintain an means of communications in case there complying with this requirement will be emergency preparedness is an interruption in phone service to the resources required to ensure that the communication plan that complied with the organization (for example, cell hospice’s emergency communication both federal and state law. Hospices will phones); and a method for sharing plan complied with these requirements. also have to review and update their information and medical documentation Based upon our experience with plans at least annually. The with other healthcare providers to hospices, we anticipate that satisfying communication plan will have to ensure continuity of care for their these requirements will require only the include the requirements listed at patients. However, many hospices, both involvement of the hospice’s § 418.113(c)(1) through (7). inpatient hospices and hospices that administrator. Thus, for each hospice, We believe that all hospices already provide care to patients in their homes, we estimate that complying with this have some type of emergency may not have formal, written emergency requirement will require 3 burden hours preparedness communication plan. preparedness communication plans. We at a cost of $240. Therefore, based on Although only inpatient hospices have expect that all hospices will need to that estimate, compliance with this a current requirement for disaster review, update, and in some cases, requirement for all 4,401 hospices will preparedness (§ 418.110(c)), it is develop new sections for their plans to require 13,203 burden hours (3 burden standard practice for healthcare ensure that those plans include all of hours for each hospice × 4,401 hospices) organizations to maintain contact the elements we proposed requiring for at a cost of $1,056,240 ($240 estimated information for their staff and for hospice communication plans. cost for each hospice × 4,401 hospices).

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TABLE 22—TOTAL COST ESTIMATE FOR A HOSPICE TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $80 3 $240

Totals ...... 3 240

Section 418.113(d) will require each necessary, to each employee hospice to bring itself into compliance hospice to develop and maintain an (§ 418.100(g)(2) and (3)). They must also with the requirements in this section. emergency preparedness training and provide employee orientation and We expect that compliance with this testing program that will be reviewed training consistent with hospice requirement will require the and updated at least annually. Section industry standards (§ 418.78(a)). In involvement of a registered nurse. We 418.113(d)(1) will require hospices to addition, inpatient hospices must expect that the registered nurse will provide initial training in emergency periodically review and rehearse their compare the hospice’s current training preparedness policies and procedures to disaster preparedness plans with their program with the facility’s emergency all hospice employees, consistent with staff, including non-employee staff preparedness plan, policies and their expected roles, and maintain (§ 418.110(c)(1)(ii)). We expect that all procedures, and communication plan, documentation of the training. The hospices already provide training to and then make any necessary revisions, hospice will also have to ensure that their employees on the facility’s existing their employees could demonstrate disaster plans, policies, and procedures. including the development of new knowledge of their emergency However, under this final rule, all training material, as needed. We procedures. Thereafter, the hospice will hospices will need to review their estimate that these tasks will require 6 have to provide emergency current training programs and compare burden hours at a cost of $360. Based on preparedness training at least annually. their contents to their updated this estimate, compliance by all 4,401 Hospices will also be required to emergency preparedness plans, policies hospices will require 26,406 burden periodically review and rehearse their and procedures, and communications hours (6 burden hours for each hospice emergency preparedness plans with plans. Hospices will then need to × 4,401 hospices) at a cost of $1,584,360 their employees, with special emphasis review, revise, and in some cases, ($360 estimated cost for each hospice × placed on carrying out the procedures develop new material for their training 4,401 hospices). We are proposing that necessary to protect patients and others. programs so that they complied with hospices also be required to review and Under current regulations, all these requirements. update their emergency preparedness hospices are required to provide an The burden associated with the training programs at least annually. initial orientation and in-service previously discussed requirements will training and educational programs, as be the time and effort necessary for a

TABLE 23—TOTAL COST ESTIMATE FOR A HOSPICE TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Registered Nurse ...... $60 6 $360

Totals ...... 6 360

Section 418.113(d)(2) will require However, this periodic rehearsal develop the necessary documentation hospices to participate in a full-scale requirement does not ensure that and the scenarios for the drills and exercise at least annually. Hospices are hospices are performing any type of exercises. We estimate that these tasks also required to participate in one drill or exercise annually or that they will require 4 burden hours at an additional testing exercise of their are documenting their responses. In estimated cost of $240. Based on this choice at least annually. Hospices will addition, there is no requirement in the estimate, in order for all 4,401 hospices also be required to analyze their current CoPs for outpatient hospices to to comply with these requirements, it responses to and maintain have an emergency plan or for these will require 17,604 burden hours (4 documentation of all their drills, hospices to test any emergency burden hours for each hospice × 4,401 tabletop exercises, and emergency procedures they may currently have. We hospices) at a cost of $1,056,240 ($240 events, and revise their emergency believe that developing the scenarios for estimated cost for each hospice × 4,401 plans, as needed. To comply with this these drills and exercises and the hospices). requirement, a hospice will need to documentation necessary to record the Thus, for all 4,401 hospices to comply develop scenarios for their drills and events during testing exercises and with all of the requirements in exercises. A hospice also will have to emergency events will be new § 418.113, it will require an estimated develop the required documentation. requirements for all hospices. 265,858 burden hours at a cost of Hospices will also have to The associated burden will be the $19,964,108. periodically review and rehearse their time and effort necessary for a hospice Comment: A commenter expressed emergency preparedness plans with to comply with these requirements. We that we underestimated the burden and their staff (including nonemployee expect that complying with these additional cost for hospices to comply staff), with special emphasis on carrying requirements will require the with these requirements since hospice out the procedures necessary to protect involvement of a registered nurse. We providers will be fairly new to many of patients and others (§ 418.110(c)(1)(ii)). expect that the registered nurse will these standards. The commenter

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indicated that hospices have not practice for healthcare providers to plan because the current hospice CoPs for typically been participants in local, for common emergencies, such as fires, inpatient hospices already require them state, or federal emergency preparedness power outages, and storms. We expect to have ‘‘a written disaster preparedness and response plans, so they will have to that hospices already have some type of plan in effect for managing the work even harder than other providers emergency or disaster plan, therefore we consequences of power failures, natural to build connections. The commenter assigned burden based on the principle disasters, and other emergencies that suggested that CMS re-evaluate the that each hospice will need to review its will affect the hospice’s ability to burden estimates in the COI section for current emergency plan to ensure that it provide care’’ (42 CFR 418.110(c)(1)(ii)). hospices. addressed the risks identified in its risk Given these current CoPs, we believe Response: We agree that hospices may assessment and complies with the that the burden estimates for hospices not be typically involved in local, state, requirements. We also expect that all are appropriate. or federal emergency planning, hospices have some emergency however, as we stated, it is standard preparedness policies and procedures

TABLE 24—TOTAL COST ESTIMATE FOR A HOSPICE TO CONDUCT TESTING EXERCISES

Position Hourly wage Burden hours Cost estimate

Registered Nurse ...... $60 4 $240

Totals ...... 4 240

TABLE 25—BURDEN HOURS AND COST ESTIMATES FOR ALL 4,401 HOSPICES TO COMPLY WITH THE ICRSIN§ 418.113 CONDITION: EMERGENCY PREPAREDNESS

Hourly labor Total labor OMB Burden per Total annual cost of cost of Total cost Regulation section(s) Control No. Respondents Responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 418.113(a) (outpatient) ...... 0938–New ...... 3,989 3,989 8 31,912 ** 2,469,191 2,469,191 § 418.113(a)(1) (inpatient) ...... 0938–New ...... 412 412 10 4,120 ** 312,708 312,708 § 418.113(a)(1) (outpatient) ...... 0938–New ...... 3,989 3,989 12 47,868 ** 3,586,111 3,586,111 § 418.113(a)(1)–(4) (inpatient) ...... 0938–New ...... 412 412 14 5,768 ** 477,508 477,508 § 418.113(a)(1)–(4) (outpatient) ...... 0938–New ...... 3,989 3,989 20 79,780 ** 6,378,411 6,378,411 § 418.113(b) (inpatient) ...... 0938–New ...... 412 412 8 3,296 ** 255,028 255,028 § 418.113(b) (outpatient) ...... 0938–New ...... 3,989 3,989 9 35,901 ** 2,788,311 2,788,311 § 418.113(c) ...... 0938–New ...... 4,401 4,401 3 13,203 ** 1,056,240 1,056,240 § 418.113(d)(1) ...... 0938–New ...... 4,401 4,401 6 26,406 ** 1,584,360 1,584,360 § 418.113(d)(2) ...... 0938–New ...... 4,401 4,401 4 17,604 ** 1,056,240 1,056,240

Totals ...... 8,802 30,395 ...... 265,858 ...... 19,964,108 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 25.

F. ICRs Regarding Emergency not have documented their risk and recommendations for changes, Preparedness (§ 441.184) assessments or performed one that will attend a follow-up meeting, perform a Section 441.184(a) will require comply with all of our requirements. final review, and approve the new risk Psychiatric Residential Treatment Therefore, we expect that all PRTFs will assessment. We expect that the Facilities (PRTFs) to develop and have to review and revise their current psychiatric registered nurse will maintain emergency preparedness plans risk assessments. coordinate the meetings, perform an and review and update those plans at We do not designate any specific initial review, offer suggested revisions, least annually. We proposed that these process or format for PRTFs to use in coordinate comments, develop a new plans meet the requirements listed at conducting their risk assessments risk assessment, and ensure that the § 441.184(a)(1) through (4). because we believe that PRTFs need necessary parties approve the new risk Section § 441.184(a)(1) will require maximum flexibility to determine the assessment. We also expect that the each PRTF to develop a documented, best way to accomplish this task. psychiatric registered nurse will spend facility-based and community-based risk However, we expect that PRTFs will more time reviewing and working on assessment that will utilize an all- include representation from or seek the risk assessment than the other hazards approach. We expect that all input from all of their major individuals. We estimate that in order PRTFs have already performed some of departments. Based on our experience for each PRTF to comply, it will require the work needed for a risk assessment with PRTFs, we expect that conducting 8 burden hours at a cost of $544. There because it is standard practice for the risk assessment will require the are currently 377 PRTFs. Therefore, healthcare facilities to prepare for involvement of the PRTF’s based on that estimate, compliance by common hazards, such as fires and administrator, a psychiatric registered all PRTFs will require 3,016 burden power outages, and disasters or nurse, and a clinical social worker. We hours (8 burden hours for each PRTF × emergencies common in their expect that all of these individuals will 377 PRTFs) at a cost of $205,088 ($544 geographic area, such as snowstorms or attend an initial meeting, review their estimated cost for each PRTF × 377 hurricanes. However, many PRTFs may current assessment, develop comments PRTFs).

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TABLE 26—TOTAL COST ESTIMATE FOR A PRTF TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $93 2 $186 Social Worker ...... 51 2 102 Registered Nurse ...... 64 4 256

Total ...... 8 544

After conducting the risk assessment, Based upon our experience with a clinical social worker will review the § 441.184(a)(1) through (4) will require PRTFs, we expect that the administrator drafts of the plan and provide comments PRTFs to develop and maintain an and psychiatric registered nurse who on it to the psychiatric registered nurse. emergency preparedness plan. Although were involved in developing the risk We estimate that for each PRTF to it is standard practice for healthcare assessment will be involved in comply with this requirement will facilities to have some type of developing the emergency preparedness require 12 burden hours at a cost of emergency preparedness plan, all PRTFs plan. However, we expect it will require $858. Thus, we estimate that it will will need to review their current plans substantially more time to complete the require 4,524 burden hours (12 burden and compare them to their risk plan than the risk assessment. We hours for each PRTF × 377 PRTFs) for assessments. Each PRTF will need to expect that the psychiatric nurse will be all PRTFs to comply with this update, revise, and, in some cases, the most heavily involved in reviewing requirement at a cost of $323,466 ($858 develop new sections to complete its and developing the PRTF’s emergency estimated cost per PRTF × 377 PRTFs). emergency preparedness plan. preparedness plan. We also expect that

TABLE 27—TOTAL COST ESTIMATE FOR A PRTF TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $93 4 $372 Social Worker ...... 51 2 102 Registered Nurse ...... 64 6 384

Total ...... 12 858

The PRTFs also will be required to Based on our experience with PRTFs, and psychiatric registered nurse. We review and update their emergency we estimate that an additional burden estimate that for each PRTF to comply preparedness plans at least annually. will be associated with reviewing the with this requirement will require 4 However, under the current CoPs, plan at least annually and we anticipate burden hours at an estimated cost of PRTFs are not required to develop an that the same staff that will be involved $272. Thus, we estimate that it will emergency preparedness plan and as with developing the emergency require 1,508 burden hours (4 burden such, there is no requirement for an preparedness plan will also be involved hours for each PRTF × 377 PRTFs) for annual review of the plan. Therefore, we in the annual review and update of the all PRTFs to comply with this will analyze the burden from this plan. The staff would include the requirement at a cost of $130,288 ($272 requirement for all PRTFs. administrator, clinical social worker, estimated cost per PRTF × 377 PRTFs).

TABLE 28—TOTAL COST ESTIMATE FOR A PRTF TO REVIEW AND UPDATE AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $93 1 $93 Social Worker ...... 51 1 51 Registered Nurse ...... 64 2 128

Total ...... 4 272

Section 441.184(b) will require each the requirements listed at with § 441.183(a)(1), (a) and (c), PRTF to develop and implement § 441.184(b)(1) through (8). respectively; and then revise their emergency preparedness policies and Since we expect that all PRTFs policies and procedures accordingly. procedures, based on their emergency already have some type of emergency We expect that the administrator and plan set forth in paragraph (a), the risk plan, we also expect that all PRTFs have a psychiatric registered nurse will be assessment at paragraph (a)(1), and the some emergency preparedness policies involved in reviewing and revising the communication plan at paragraph (c). and procedures. However, we expect policies and procedures and, if needed, We also proposed requiring PRTFs to that all PRTFs will need to review their developing new policies and review and update these policies and policies and procedures; compare them procedures. We estimate that it will procedures at least annually. At a to their risk assessments, emergency require 9 burden hours at a cost of $663 minimum, we will require that the preparedness plans, and communication for each PRTF to comply with this PRTF’s policies and procedures address plans they developed in accordance requirement. Based on this estimate, it

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will require 3,393 burden hours (9 PRTFs) for all PRTFs to comply with ($6632 estimated cost per PRTF × 377 burden hours for each PRTF × 377 this requirement at a cost of $249,951 PRTFs).

TABLE 29—TOTAL COST ESTIMATE FOR A PRTF TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $93 3 $279 Registered Nurse ...... 64 6 384

Total ...... 9 663

Section 441.184(c) will require each alternate means of communication in involvement of the PRTF’s PRTF to develop and maintain an case there is an interruption in phone administrator and a psychiatric emergency preparedness service to the facility; and a method for registered nurse to review, revise, and if communication plan that complied with sharing information and medical needed, develop new sections for the both federal and state law. PRTFs also documentation with other healthcare PRTF’s emergency preparedness will have to review and update these providers to ensure continuity of care communication plan. We estimate that plans at least annually. The for their residents. However, most for each PRTF to comply will require 5 communication plan will have to PRTFs may not have formal, written burden hours at a cost of $378. Based on include the information set out in emergency preparedness that estimate, for all PRTFs to comply § 441.184(c)(1) through (7). communication plans. Therefore, we will require 1,885 burden hours (5 We expect that all PRTFs have some expect that all PRTFs will need to burden hours for each PRTF × 377 type of emergency preparedness review and, if needed, revise their PRTFs) at a cost of $142,506 ($378 communication plan. It is standard plans. × practice for healthcare facilities to Based on our experience with PRTFs, estimated cost for each PRTF 377 maintain contact information for both we anticipate that satisfying these PRTFs). staff and outside sources of assistance; requirements will require the

TABLE 30—TOTAL COST ESTIMATE FOR A PRTF TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $93 2 $186 Registered Nurse ...... 64 3 192

Total ...... 5 378

Section 441.184(d) will require PRTFs the PRTF will have to provide nurse. We expect that the psychiatric to develop and maintain emergency emergency preparedness training at registered nurse will review the PRTF’s preparedness training programs and least annually. current training program; determine review and update those programs at Based on our experience with PRTFs, what tasks will need to be performed least annually. Section 441.184(d)(1) we expect that all PRTFs have some and what materials will need to be will require PRTFs to provide initial type of emergency preparedness training developed; and develop the necessary training in emergency preparedness program. However, PRTFs will need to materials. We estimate that for each policies and procedures to all new and review their current training programs PRTF to comply with the requirements and compare them to their risk existing staff, individuals providing in this section will require 10 burden assessments and emergency services under arrangement, and hours at a cost of $640. Based on this preparedness plans, policies and volunteers, consistent with their procedures, and communication plans estimate, for all PRTFs to comply with expected roles, and maintain and update and, in some cases, develop this requirement will require 3,770 documentation of the training. The new sections for their training programs. burden hours (10 burden hours for each × PRTF will also have to ensure that their We expect that complying with this PRTF 377 PRTFs) at a cost of $241,280 staff could demonstrate knowledge of requirement will require the ($640 estimated cost for each PRTF × the emergency procedures. Thereafter, involvement of a psychiatric registered 377 PRTFs).

TABLE 31—TOTAL COST ESTIMATE FOR A PRTF TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Registered Nurse ...... $64 10 $640

Total ...... 10 640

Section 441.184(d)(2) will require also required to participate in one have to analyze their responses to and PRTFs to participate in a full-scale additional testing exercise of their maintain documentation of all drills, exercise at least annually. PRTFs are choice at least annually. PRTFs will also tabletop exercises, and emergency

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events, and revise their emergency type of emergency preparedness testing developed the emergency preparedness plans, as needed. However, if a PRTF program and most, if not all, PRTFs training program will develop the experienced an actual natural or man- already conduct some type of drill or scenarios for the testing exercises and made emergency that required exercise to test their emergency the accompanying documentation. We activation of its emergency plan, that preparedness plans. We also expect that estimate that for each PRTF to comply PRTF will be exempt from engaging in they have already developed some type with the requirements in this section a community or a full-scale exercise for of documentation for testing exercises will require 3 burden hours at a cost of 1 year following the onset of the actual and emergency events. However, we do $192. We estimate that for all PRTFs to emergency event. To comply with this not expect that all PRTFs are conducting comply will require 1,131 burden hours requirement, PRTFs will need to two testing exercises annually or have (3 burden hours for each PRTF × 377 develop scenarios for each drill and developed the appropriate PRTFs) at a cost of $72,384 ($192 exercise and the documentation documentation. Thus, we will analyze estimated cost for each PRTF × 377 necessary to record and analyze testing the burden of these requirements for all PRTFs). exercises and actual emergency events. PRTFs. Based on our experience with PRTFs, Based on our experience with PRTFs, we expect that all PRTFs have some we expect that the same individual who

TABLE 32—TOTAL COST ESTIMATE FOR A PRTF TO CONDUCT TESTING EXERCISES

Position Hourly wage Burden hours Cost estimate

Registered Nurse ...... $64 3 $192

Total ...... 3 192

Based on the previous analysis, for all this final rule will require 17,719 377 PRTFs to comply with the ICRs in burden hours at a cost of $1,234,675. TABLE 33—BURDEN HOURS AND COST ESTIMATES FOR ALL 377 PRTFS TO COMPLY WITH THE ICRS CONTAINED IN § 441.184 CONDITION: EMERGENCY PREPAREDNESS

Hourly labor Total labor OMB Burden per Total annual cost of cost of Total cost Regulation section(s) Control No. Respondents Responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 441.184(a) ...... 0938-New ...... 377 377 4 1,508 ** 130,288 130,288 § 441.184(a)(1) ...... 0938-New ...... 377 377 8 3,016 ** 205,088 205,088 § 441.184(a)(1)-(4) ...... 0938-New ...... 377 377 12 4,524 ** 323,466 323,466 § 441.184(b) ...... 0938-New ...... 377 377 9 3,393 ** 249,951 249,951 § 441.184(c) ...... 0938-New ...... 377 377 5 1,885 ** 142,506 142,506 § 441.184(d)(1) ...... 0938-New ...... 377 377 10 3,770 ** 241,280 241,280 § 441.184(d)(2) ...... 0938-New ...... 377 377 3 1,131 ** 72,384 72,384

Totals ...... 377 2,639 ...... 19,277 ...... 1,364,963 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 33.

G. ICRs Regarding Emergency emergencies the organization might well as participants receiving services in Preparedness (§ 460.84) encounter, such as fires, loss of power, their homes. loss of communications, etc. Therefore, For the purpose of determining the Section 460.84(a) will require the we believe that each PACE organization burden, we will assume that a PACE Program for the All-Inclusive Care for should have already performed some organization’s risk assessment, the Elderly (PACE) organizations to sort of risk assessment. emergency plan, policies and develop and maintain emergency procedures, communication plan, and Under the current regulations, PACE preparedness plans and review and training and testing program will apply update those plans at least annually. We organizations are required to establish, to all of a PACE organization’s centers. proposed that each plan must meet the implement, and maintain procedures for Based on the existing PACE regulations, requirements listed at § 460.84(a)(1) managing medical and non-medical we expect that they already assess their through (4). emergencies and disasters that are likely physical structure(s), the areas in which Section 460.84(a)(1) will require to threaten the health or safety of the they are located, and the location(s) of PACE organizations to develop participants, staff, or the public their participants. However, these risk documented, facility-based and (§ 460.72(c)(1)). The definition of assessments may not be documented or community-based risk assessments ‘‘emergencies’’ includes natural address all of our requirements. utilizing an all-hazards approach. We disasters that are likely to occur in the Therefore, we expect that all 119 PACE believe that the performance of a risk PACE organization’s area organizations will have to review, assessment is a standard practice, and (§ 460.72(c)(2)). PACE organizations are revise, and update their current risk that all of the PACE organizations have required to plan for emergencies assessments. already conducted some sort of risk involving participants who are in their We have not designated any specific assessment based on common center(s) at the time of an emergency, as process or format for PACE

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organizations to use in conducting their meeting or individually review relevant that the quality improvement nurse and risk assessments because we believe that sections of the current risk assessment the home care coordinator will spend they will be able to determine the best and prepare and forward their more time reviewing and developing the way for their facilities to accomplish comments to the quality assurance risk assessment than the other this task. However, we expect that they nurse. After initial comments are individuals. We estimate that complying will include representation or input received, some will attend a follow-up with the requirement to conduct a risk from all of their major departments. meeting, perform a final review, and assessment will require 14 burden hours Based on our experience with PACE ensure the new risk assessment was at a cost of $1,105. For all 119 PACE organizations, we expect that approved by the appropriate organizations to comply with this conducting the risk assessment will individuals. We expect that the quality requirement will require an estimated require the involvement of the PACE improvement nurse will coordinate the 1,666 burden hours (14 burden hours for organization’s program director, medical meetings, review the current risk each PACE organization × 119 PACE director, home care coordinator, quality assessment, suggest revisions, improvement nurse, social worker, and coordinate comments, develop the new organizations) at a cost of $131,495 ($1,105 estimated cost for each PACE a driver. We expect that these risk assessment, and ensure that the × individuals will either attend an initial necessary parties approve it. We expect organization 119 PACE organizations).

TABLE 34—TOTAL COST ESTIMATE FOR A PACE TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Program Director ...... $110 3 $330 Medical Director ...... 182 1 182 Home Care Coordinator ...... 64 4 256 Registered Nurse/Quality Improvement ...... 64 4 256 Social Worker ...... 55 1 55 Driver ...... 26 1 26

Total ...... 14 1,105

After conducting a risk assessment, requirement does not guarantee that all emergency preparedness plan. We PACE organizations will have to PACE organizations have developed a expect that the program director, home develop and maintain emergency plan that complies with our care coordinator, and social worker will preparedness plans that satisfied all of requirements. review the current plan, provide the requirements in § 460.84(a)(1) Thus, we expect that all PACE comments, and assist the quality through (4). In addition to the organizations will need to review their improvement nurse in developing the requirement to establish, implement, current plans and compare them to their final plan. Other staff members will and maintain procedures for managing risk assessments. PACE organizations work only on the sections of the plan emergencies and disasters, current will need to update, revise, and, in some that will be relevant to their areas of regulations require PACE organizations cases, develop new sections to complete responsibility. to have a governing body or designated their emergency preparedness plans. We estimate that for each PACE person responsible for developing Based upon our experience with organization to comply with the policies on participant health and PACE organizations, we expect that the requirement for an emergency safety, including a comprehensive, same individuals who were involved in preparedness plan will require 23 systemic operational plan to ensure the developing the risk assessment will be burden hours at a cost of $1,798. We health and safety of the PACE involved in developing the emergency estimate that for all PACE organizations organization’s participants preparedness plan. However, we expect to comply will require 2,737 burden (§ 460.62(a)(6)). We expect that an that it will require more time to hours (23 burden hours for each PACE emergency preparedness plan will be an complete the plan. We expect that the Organization × 119 PACE organizations) essential component of such a quality improvement nurse will have at a cost of $213,962 ($1,798 estimated comprehensive, systemic operational primary responsibility for reviewing and cost for each PACE organization × 119 plan. However, this regulatory developing the PACE organization’s PACE organizations).

TABLE 35—TOTAL COST ESTIMATE FOR A PACE TO DEVELOP AN EMERGENCY PLAN

Position Hourly wage Burden hours Cost estimate

Program Director ...... $110 4 $440 Medical Director ...... 182 2 364 Home Care Coordinator ...... 64 7 448 Registered Nurse/Quality Improvement ...... 64 6 384 Social Worker ...... 55 2 110 Driver ...... 26 2 52

Total ...... 23 1,798

The PACE organizations will also be emergency preparedness plans at least organizations are already reviewing required to review and update their annually. We believe that PACE their emergency preparedness plans

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periodically. Therefore, we believe Current regulations already require The burden associated with the compliance with this requirement will that PACE organizations establish, requirements will be the resources constitute a usual and customary implement, and maintain procedures for needed to review, revise, and, if needed, business practice for PACE managing emergencies and disasters develop new emergency preparedness organizations and will not be subject to (§ 460.72(c)). The definition of policies and procedures. We expect that the PRA in accordance with the ‘‘emergencies’’ includes medical and the program director, home care implementing regulations of the PRA 5 nonmedical emergencies, such as coordinator, and quality improvement CFR 1320.3(b)(2). natural disasters likely to occur in a nurse will be primarily responsible for Section 460.84(b) will require each PACE organization’s area reviewing, revising, and if needed, PACE organization to develop and (§ 460.72(c)(2)). In addition, all PACE developing any new policies and implement emergency preparedness organizations must have a governing procedures needed to comply with our policies and procedures based on the body or a designated person who emergency plan set forth in paragraph functions as the governing body requirements. We estimate that for each (a), the risk assessment at paragraph responsible for developing policies on PACE organization to comply with our (a)(1), and the communication plan at participant health and safety requirements will require 12 burden paragraph (c). It will also require PACE (§ 460.62(a)(6)). Thus, we expect that all hours at a cost of $860. Therefore, based organizations to review and update PACE organizations have some on this estimate, for all PACE these policies and procedures at least emergency preparedness policies and organizations to comply will require annually. At a minimum, we will procedures. However, these 1,428 burden hours (12 burden hours for require that a PACE organization’s requirements do not ensure that all each PACE organization × 119 PACE policies and procedures address the PACE organizations have policies and organizations) at a cost of $102,340 requirements listed at § 460.84(b)(1) procedures that will comply with our ($860 estimated cost for each PACE through (9). requirements. organization × 119 PACE organizations).

TABLE 36—TOTAL COST ESTIMATE FOR A PACE TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Program Director ...... $110 2 $220 Home Care Coordinator ...... 64 5 320 Registered Nurse/Quality Improvement ...... 64 5 320

Total ...... 12 860

We proposed that each PACE All PACE organizations must have a emergency preparedness organization must also review and governing body (or a designated person communication plan. However, each update its emergency preparedness who functions as the governing body) PACE organization will need to review policies and procedures at least that is responsible for developing its current plan and revise or, in some annually. We believe that PACE policies on participant health and cases, develop new sections to comply organizations are already reviewing safety, including a comprehensive, with our requirements. their emergency preparedness policies systemic operational plan to ensure the Based on our experience with PACE and procedures periodically. Thus, health and safety of the PACE organizations, we expect that the home compliance with this requirement will organization’s participants care coordinator and the quality constitute a usual and customary (§ 460.62(a)(6)). We expect that the assurance nurse will be primarily business practice and will not be subject PACE organizations’ comprehensive, responsible for reviewing, and if to the PRA in accordance with the systemic operational plans will include needed, revising, and developing new implementing regulations of the PRA at at least some of our requirements. In sections for the communication plan. 5 CFR 1320.3(b)(2). addition, it is standard practice in the We estimate that for each PACE healthcare industry to maintain contact organization to comply with the Section 460.84(c) will require each information for both staff and outside requirements will require 7 burden PACE organization to develop and sources of assistance; alternate means of hours at a cost of $448. Therefore, based maintain an emergency preparedness communications in case there is an on this estimate, for all PACE communication plan that complied with interruption in phone service to the organizations to comply with this both federal and state law. Each PACE facility; and a method for sharing requirement will require 833 burden organization will also have to review information and medical documentation hours (7 burden hours for each PACE and update this plan at least annually. with other healthcare providers to organization × 119 PACE organizations) The communication plan must include ensure continuity of care for patients. at a cost of $53,312 ($448 estimated cost the information set out at § 460.84(c)(1) Thus, we expect that all PACE for each PACE organization × 119 PACE through (7). organizations have some type of organizations).

TABLE 37—TOTAL COST ESTIMATE FOR A PACE TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Home Care Coordinator ...... $64 4 $256 Registered Nurse/Quality Improvement ...... 64 3 192

Total ...... 7 448

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Each PACE organization must also providing on-site services under organization will also need to revise review and update its emergency arrangement, contractors, participants, and, in some cases, develop new preparedness communication plan at and volunteers, consistent with their sections to ensure that its emergency least annually. We believe that PACE expected roles and maintain preparedness training program organizations are already reviewing and documentation of this training. PACE complied with our requirements. We updating their emergency preparedness organizations will also have to ensure expect that the quality assurance nurse communication plans periodically. that their staff could demonstrate will review all elements of the PACE Thus, we believe compliance with this knowledge of the emergency organization’s training program and requirement will constitute a usual and procedures. Thereafter, PACE determine what tasks will need to be customary business practice for PACE organizations will be required to performed and what materials will need organizations and will not be subject to provide this training annually. to be developed to comply with our the PRA in accordance with the requirements. We expect that the home implementing regulations of the PRA at Current regulations require PACE care coordinator will work with the 5 CFR 1320.3(b)(2). organizations to provide periodic Section 460.84(d) will require PACE orientation and appropriate training to quality assurance nurse to develop the organizations to develop and maintain their staffs and participants in revised and updated training program. emergency preparedness training and emergency procedures (§ 460.72(c)(3)). We estimate that for each PACE testing programs and review and update However, these requirements do not organization to comply with the those programs at least annually. We ensure that all PACE organizations will requirements will require 12 burden proposed that each PACE organization be in compliance with our hours at a cost of $768. Therefore, it will will have to meet the requirements requirements. Thus, each PACE require an estimated 1,428 burden hours listed at § 460.84(d)(1) and (2). organization will need to review its (12 burden hours for each PACE Section 460.84(d)(1) will require current training program and compare organization × 119 PACE organizations) PACE organizations to provide initial the training program to its risk to comply with this requirement at a training on their emergency assessment, emergency preparedness cost of $91,392 ($768 estimated cost for preparedness policies and procedures to plan, policies and procedures, and each PACE organization × 119 PACE all new and existing staff, individuals communication plan. The PACE organizations).

TABLE 38—TOTAL COST ESTIMATE FOR A PACE TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Home Care Coordinator ...... $64 3 $192 Registered Nurse/Quality Improvement ...... 64 9 576

Total ...... 12 768

The PACE organizations will also be be exempt from engaging in a based, tabletop exercise; performing a required to review and update their community or individual, facility-based community-based full-scale exercise; emergency preparedness training full-scale exercise for 1 year following and using different scenarios for the program at least annually. We believe the onset of the actual event. To comply testing exercises. that PACE organizations are already with these requirements, PACE The 119 PACE organizations will be reviewing and updating their emergency organizations will need to develop a required to develop scenarios for testing preparedness training programs specific scenario for each drill and exercises and the documentation periodically. Therefore, we believe exercise. The PACE organizations will necessary to record and analyze their compliance with this requirement will also have to develop the documentation response to all exercises and any constitute a usual and customary necessary for recording and analyzing emergency events. Based on our business practice for PACE their response to all testing exercises experience with PACE organizations, we organizations and will not be subject to and emergency events. expect that the same individuals who the PRA in accordance with the Current regulations require each developed their emergency implementing regulations of the PRA at PACE organization to conduct a test of preparedness training programs will 5 CFR 1320.3(b)(2). its emergency and disaster plan at least develop the required documentation. Section 460.84(d)(2) will require annually (42 CFR 460.72(c)(5)). They We expect the quality improvement PACE organizations to participate in a also must evaluate and document the nurse will spend more time on these full-scale exercise at least annually. effectiveness of their emergency and activities than the healthcare They will also be required to conduct disaster plans. Thus, PACE coordinator. We estimate that this one additional exercise of their choice at organizations already conduct at least activity will require 5 burden hours for least annually. PACE organizations will one test annually of their plans. We each PACE organization at a cost of also be required to analyze their expect that as part of testing their $320. We estimate that for all PACE responses to, and maintain emergency plans annually, PACE organizations to comply with these documentation of, all testing exercises organizations will develop a scenario for requirements will require 595 burden and any emergency events they and document the testing. However, this hours (5 burden hours for each PACE experienced. If a PACE organization does not ensure that all PACE organization × 119 PACE organizations) experienced an actual natural or man- organizations will be in compliance at a cost of $38,080 ($595 estimated cost made emergency that required with all of our requirements, especially for each PACE organization × 119 PACE activation of its emergency plan, it will the requirement for conducting a paper- organizations).

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TABLE 39—TOTAL COST ESTIMATE FOR A PACE TO CONDUCT TESTING EXERCISES

Position Hourly wage Burden hours Cost estimate

Home Care Coordinator ...... $64 4 $256 Registered Nurse/Quality Improvement ...... 64 1 64

Total ...... 5 320

TABLE 40—BURDEN HOURS AND COST ESTIMATES FOR ALL 119 PACE ORGANIZATIONS TO COMPLY WITH THE ICRS CONTAINED IN § 460.84 EMERGENCY PREPAREDNESS

Hourly labor Total labor OMB Burden per Total annual cost of cost of Total cost Regulation section(s) Control No. Respondents Responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 460.84(a)(1) ...... 0938—New .... 119 119 14 1,666 ** 131,495 131,495 § 460.84(a)(1)–(4) ...... 0938—New .... 119 119 23 2,737 ** 213,962 213,962 § 460.84(b) ...... 0938—New .... 119 119 12 1,428 ** 102,340 102,340 § 460.84(c) ...... 0938—New .... 119 119 7 833 ** 53,312 53,312 § 460.84(d)(1) ...... 0938—New .... 119 119 12 1,428 ** 91,392 91,392 § 460.84(d)(2) ...... 0938—New .... 119 119 5 595 ** 38,080 38,080

Totals ...... 119 714 ...... 8,687 ...... 630,581 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 40.

H. ICRs Regarding Condition of Three organizations have accrediting emergencies (CAMH, Standard EC.4.11, Participation: Emergency Preparedness authority for these hospitals: TJC, CAMH Refreshed Core, January 2008, p. (§ 482.15) formerly known as the Joint EC–13a). Individual standards have EPs, Section 482.15(a) will require Commission on the Accreditation of which provide the detailed and specific hospitals to develop and maintain Healthcare Organizations (JCAHO), the performance expectations, structures, emergency preparedness plans. We AOA/HFAP, and DNV GL. and processes for each standard (CAMH, proposed that hospitals be required to Accreditation can substantially affect CAMH Refreshed Core, January 2008, p. review and update their emergency the burden a hospital will sustain under HM–6). The EPs for Standard EC.4.11 preparedness plans at least annually this final rule. The Joint Commission require, among other things, that and meet the requirements set out at accredits 3,448 hospitals. Many of our hospitals conduct a hazard vulnerability § 482.15(a)(1) through (4). Note that we requirements are similar or virtually analysis (HVA) (CAMH, Standard obtain data on the number of hospitals, identical to the standards, rationales, EC.4.11, EP 2, CAMH Refreshed Core, both accredited and non-accredited, and elements of performance (EPs) January 2008, p. EC–13a). Performing an from the CMS CASPER data system, required for TJC accreditation. TJC HVA will require a hospital to identify which are updated periodically by the standards, rationales, and elements of the events that could possibly affect individual states. Due to variations in performance (EPs) are on the TJC Web demand for the hospital’s services or the the timeliness of the data submissions, site at http://www.jointcommission.org/. hospital’s ability to provide services. A all numbers are approximate, and the The AOA/HFAP and DNV GL hospital TJC-accredited hospital also must number of accredited and non- accreditation requirements do not determine the likeliness of the accredited hospitals shown may not emphasize emergency preparedness. In identified risks occurring, as well as equal the number of hospitals at the addition, these hospitals account for their consequences. Thus, we expect time of this final rule’s publication. In less than 5 percent of all of the that TJC-accredited hospitals already addition, some hospitals may have hospitals. Thus, for purposes of conduct an HVA that complies with our chosen to be accredited by more than determining the burden, we have requirements and that any additional one accrediting organization. included the AOA/HFAP-accredited tasks necessary to comply will be There are approximately 4,793 hospitals and the DNV GL-accredited minimal. Therefore, for TJC-accredited Medicare-certified hospitals. This hospitals in with the hospitals that are hospitals, the risk assessment includes 121 critical access hospitals not accredited. Therefore, unless requirement will constitute a usual and (CAHs) that have rehabilitation or indicated otherwise, we have analyzed customary business practice and will psychiatric distinct part units (DPUs) as the burden for the 3,448 TJC-accredited not be subject to the PRA in accordance of June 30, 2016 CASPER data. The hospitals separately from the remaining with the implementing regulations of services provided by CAH psychiatric or 1,345 non TJC-accredited hospitals the PRA at 5 CFR 1320.3(b)(2). rehabilitation DPUs must comply with (4,793 hospitals¥3,448 TJC-accredited Section 482.15(a)(1) will require that the hospital Conditions of Participation hospitals). hospitals perform a documented, (CoPs) (42 CFR 485.647(a)). RNHCIs and We have used TJC’s ‘‘Comprehensive facility-based and community-based risk CAHs that do not have DPUs have been Accreditation Manual for Hospitals: The assessment, utilizing an all-hazards excluded from this number and are Official Handbook 2008 (CAMH)’’ to approach. We expect that most non TJC- addressed separately in this analysis. Of determine the burden for TJC-accredited accredited hospitals have already the 4,793 hospitals reported in CMS’ hospitals. In the chapter entitled, performed at least some of the work CASPER data system, approximately ‘‘Management of the Environment of needed for a risk assessment. The Niska 3,913 are accredited hospitals and the Care’’ (EC), hospitals are required to and Burt article indicated that most remainder are non-accredited hospitals. plan for managing the consequences of hospitals already have plans for natural

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disasters. However, many may not have of nursing, the pharmacy director, the necessary parties approve it. We expect thoroughly documented this activity or facilities director, the health that the hospital administrator will performed as thorough a risk assessment information services director, the safety spend more time reviewing the risk as needed to comply with our director, the security manager, the assessment than most of the other requirements. community relations manager, the food individuals. We have not designated any specific services director, and administrative We estimate that the risk assessment process or format for hospitals to use in support staff. We expect that most of will require 34 burden hours to conducting a risk assessment because these individuals will attend an initial we believe that hospitals need the meeting, review relevant sections of complete at a cost of $4,232 for each flexibility to determine how best to their current risk assessment, prepare non-TJC accredited hospital. There are accomplish this task. However, we and send their comments to the risk approximately 1,345 non TJC-accredited expect that hospitals will obtain input management director, attend a follow- hospitals. Therefore, it will require an from all of their major departments up meeting, perform a final review, and estimated 45,730 burden hours (34 when performing a risk assessment. approve the new risk assessment. burden hours for each non TJC- Based on our experience, we expect that We expect that the risk management accredited hospitals × 1,345 non TJC- conducting a risk assessment will director will coordinate the meetings, accredited hospitals) for all non TJC- require the involvement of at least a review and comment on the current risk accredited hospitals to comply at a cost hospital administrator, the risk assessment, suggest revisions, of $5,692,040 ($4,232 estimated cost for management director, the chief medical coordinate comments, develop the new each non TJC-hospital × 1,345 non TJC- officer, the chief of surgery, the director risk assessment, and ensure that the accredited hospitals).

TABLE 41—TOTAL COST ESTIMATE FOR A NON-TJC ACCREDITED HOSPITAL TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $172 4 $688 Risk Management Director ...... 104 8 832 Chief Medical Officer/Medical Director ...... 199 2 398 Chief of Surgery ...... 231 2 462 Director of Nursing ...... 104 3 312 Pharmacy Director ...... 142 3 426 Facilities Director ...... 104 3 312 Health Information Services Director ...... 104 2 208 Security Manager ...... 104 2 208 Community Relations Manager ...... 107 2 214 Food Services Manager ...... 70 2 140 Medical Secretary ...... 32 1 32

Total ...... 34 4,232

Section 482.15(a)(1) through (4) will services’’ (CAMH, Standard EC.4.11, We expect that most, if not all, non require hospitals to develop and EPs 7 and 8, p. EC–13a). In addition, TJC-accredited hospitals already have maintain emergency preparedness hospitals are required to have plans to some type of emergency preparedness plans. We expect that all hospitals will manage ‘‘clinical services for vulnerable plan. The Niska and Burt article noted compare their risk assessments to their populations served by the hospital, that the majority of hospitals have plans emergency plans and revise and, if including patients who are pediatric, for natural disasters; incendiary necessary, develop new sections for geriatric, disabled or have serious incidents; and biological, chemical, and their plans. TJC-accredited hospitals chronic conditions or addictions’’ radiological terrorism. In addition, all must develop and maintain written (CAMH, Standard EC.4.18, EP 2, p. EC– hospitals must already meet the Emergency Operations Plans (EOPs) 13g). Hospitals also must plan how to requirements set out at 42 CFR 482.41, (CAMH, Standard EC.4.12, EP 1, CAMH manage the mental health needs of their including emergency power, lighting, Refreshed Care, January 2008, p. EC– gas and water supply requirements as patients (CAMH, Standard EC.4.18, EP 13b). The EOP should describe an ‘‘all- well as specified Life Safety Code 4, EC–13g). Thus, we expect that TJC- hazards’’ approach to coordinating six provisions. However, those existing accredited hospitals have already critical areas: Communications, plans may not be fully compliant with resources and assets, safety and developed and are maintaining EOPs our requirements. Thus, it will be security, staff roles and responsibilities, that comply with the requirement for an necessary for non TJC-accredited utilities, and patient clinical and emergency plan in this final rule. If a hospitals to review their current plans support activities during emergencies TJC-accredited hospital needed to and compare them to their risk (CAMH, Standard EC.4.13–EC.4.18, complete additional tasks to comply assessments and revise, update, or, in CAMH Refreshed Core, January 2008, with the requirement, we believe that some cases, develop new sections for pp. EC–13b–EC–13g). Hospitals also the burden will be negligible. Therefore, their emergency plans. must include in their EOP ‘‘[r]esponse for TJC-accredited hospitals, this Based on our experience with strategies and actions to be activated requirement will constitute a usual and hospitals, we expect that the same during the emergency’’ and ‘‘[r]ecovery customary business practice and will individuals who were involved in strategies and actions designed to help not be subject to the PRA in accordance developing the risk assessment will be restore the systems that are critical to with the implementing regulations of involved in developing the emergency resuming normal care, treatment and the PRA at 5 CFR 1320.3(b)(2). preparedness plan. However, we

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estimate that it will require substantially hospital. There are approximately 1,345 1,345 non TJC-accredited hospitals) to more time to complete an emergency non TJC-accredited hospitals. Therefore, complete an emergency preparedness preparedness plan. We estimate that based on this estimate, it will require plan at a cost of $9,963,760 ($7,408 complying with this requirement will 83,390 burden hours for all non TJC- estimated cost for each non TJC- require 62 burden hours at a cost of accredited hospitals (62 burden hours accredited hospital × 1,345 non TJC- $7,408 for each non TJC-accredited for each non TJC-accredited hospitals × accredited hospitals).

TABLE 42—TOTAL COST ESTIMATE FOR A NON-TJC ACCREDITED HOSPITAL TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $172 4 $688 Risk Management Director ...... 104 20 2,080 Chief Medical Officer/Medical Director ...... 199 3 597 Chief of Surgery ...... 231 3 693 Director of Nursing ...... 104 6 624 Pharmacy Director ...... 142 5 710 Facilities Director ...... 104 6 624 Health Information Services Director ...... 104 3 312 Security Manager ...... 104 6 624 Community Relations Manager ...... 107 2 214 Food Services Manager ...... 70 3 210 Medical Secretary ...... 32 1 32

Total ...... 62 7,408

Under this final rule, a hospital also during and after emergencies (CAMH, subsistence requirements in will be required to review and update Standard LC.3.90, EP 1, CAMH § 482.15(b)(1). its emergency preparedness plan at least Refreshed Core, January 2008, p. LD– Section 482.15(b)(2) will require annually. We believe that hospitals 15). Thus, we expect that TJC-accredited hospitals to have policies and already review their emergency hospitals already have some policies procedures to track the location of on- preparedness plans periodically. and procedures related to our duty staff and sheltered patients in the Therefore, we believe compliance with requirements. In addition to meeting hospital’s care during an emergency. this requirement will constitute a usual TJC standards, hospitals are required to TJC-accredited hospitals must plan for and customary business practice for meet state and local and licensing communicating with patients and their hospitals and will not be subject to the requirements. Based on these families at the beginning of and during PRA in accordance with the requirements, hospitals have been an emergency (CAMH, Standard implementing regulations of the PRA at operating within this framework in the EC.4.13, EPs 1, 2, and 5, p. EC–13c). We 5 CFR 1320.3(b)(2). delivery of patient care services. State expect that TJC-accredited hospitals will Under § 482.15(b), we will require and local laws require fire, emergency, be in compliance with § 482.15(b)(2). each hospital to develop and implement and safety codes that have an impact on Section 482.15(b)(3) will require emergency preparedness policies and operations during an emergency or a hospitals to have policies and procedures based on its emergency plan disaster. As discussed later, many of the procedures for a plan for the safe set forth in paragraph (a), the risk requirements in § 482.15(b) has a evacuation from the hospital. TJC- assessment at paragraph (a)(1), and the corresponding requirement in the TJC accredited hospitals are required to communication plan at paragraph (c). hospital accreditation standards. Hence, make plans to evacuate patients as part We will also require hospitals to review we will discuss each section of managing their clinical activities and update these policies and individually. (CAMH, Standard EC.4.18, EP 1, p. EC– procedures at least annually. At a Section 482.15(b)(1) will require 13g). They also must plan for the minimum, we will require that the hospitals to have policies and evacuation and transport of patients, as policies and procedures address the procedures for the provision of well as their information, medications, requirements at § 482.15(b)(1) through subsistence needs for staff and patients, supplies, and equipment, to alternative (8). whether they evacuate or shelter in care sites (ACSs) when the hospital We will expect all hospitals to review place. TJC-accredited hospitals are cannot provide care, treatment, and their emergency preparedness policies required to make plans for obtaining services in their facility (CAMH, and procedures and compare them to and replenishing medical and non- Standard EC.4.14, EPs 9–11, p. EC–13d). their emergency plans, risk assessments, medical supplies, including food, water, Section 482.15(b)(3) also will require and communication plans. We expect and fuel for generators and hospitals to have ‘‘primary and alternate that hospitals will then review, revise, transportation vehicles (CAMH, means of communication with external and, if necessary, develop new policies Standard EC.4.14, EPs 1–8 and 10–11, p. sources of assistance.’’ TJC-accredited and procedures that comply with our EC–13d). In addition, hospitals must hospitals must plan for communicating requirements. identify alternative means of providing with external authorities once the The CAMH’s chapter entitled, electricity, water, fuel, and other hospital initiates its emergency response ‘‘Leadership’’ (LD), requires TJC- essential utility needs in cases when measures (CAMH, Standard EC.4.13, EP accredited hospital leaders to ‘‘develop their usual supply is disrupted or 4, p. EC–13c). Thus, TJC-accredited policies and procedures that guide and compromised (CAMH, Standard hospitals will be in compliance with support patient care, treatment, and EC.4.17, EPs 1–5, p. EC–13f). Thus, we most of the requirements in services.’’ The policies and procedures expect that TJC-accredited hospitals will § 482.15(b)(3). However, we do not are to guide all patient care, including be in compliance with our provision of believe these requirements will ensure

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compliance with the requirement that staff roles and responsibilities in their their care, treatment, and services on the hospital establish policies and EOPs and ensure that they train their site (CAMH, Standard EC.4.14, EPs 10 procedures for staff responsibilities. staffs for their assigned roles (CAMH, and 11, p. EC–13d). We expect that TJC- Section 482.15(b)(4) will require Standard EC.4.16, EPs 1 and 2, p. EC– accredited hospitals will be in hospitals to have policies and 13e). The rationale for Standard EC.4.15 compliance with the requirements we procedures that address a means to indicates that the ‘‘hospital determines proposed in § 482.15(b)(8). shelter in place for patients, staff, and the type of access and movement to be In summary, we expect that TJC- volunteers who remain at the facility. allowed by . . . emergency volunteers accredited hospitals have developed The rationale for CAMH Standard . . . when emergency measures are and are maintaining policies and EC.4.18 states, ‘‘a catastrophic initiated.’’ In addition, in the chapter emergency may result in the decision to entitled ‘‘Medical Staff’’ (MS), hospitals procedures that will comply with the keep all patients on the premises in the ‘‘may grant disaster privileges to requirements in § 482.15(b), except for interest of safety’’ (CAMH, Standard volunteers that are eligible to be § 482.15(b)(3), (6), and (7). Later we will EC.4.18, p. EC–13f). We expect that TJC- licensed independent practitioners’’ discuss the burden on TJC-accredited accredited hospitals will be in (CAMH, Standard MS.4.110, CAMH hospitals with respect to these compliance with our shelter in place Refreshed Care, January 2008, p. MS– provisions. We expect that any requirement in § 482.15(b)(4). 27). Finally, in the chapter entitled modifications that TJC-accredited Section 482.15(b)(5) will require ‘‘Management of Human Resources’’ hospitals will need to make to comply hospitals to have policies and (HR), hospitals ‘‘may assign disaster with the remaining requirements will procedures that address a system of responsibilities to volunteer not impose a burden above that incurred medical documentation that preserves practitioners’’ (CAMH, Standard as part of usual and customary business patient information, protects the HR.1.25, CAMH Refreshed Core, January practices. Thus, with the exception of confidentiality of patient information, 2008, p. HR–5). Although TJC the requirements set out at and ensures that records are secure and accreditation requirements partially § 482.15(b)(3), (6), and (7), we believe readily available. The CAMH chapter address our requirements, we do not the requirements constitute usual and entitled ‘‘Management of Information’’ believe these requirements will ensure customary business practices and will requires TJC-accredited hospitals to compliance with all requirements in in not be subject to the PRA in accordance have storage and retrieval systems for § 482.15(b)(6). with the implementing regulations of their clinical/service and hospital- Section 482.15(b)(7) will require the PRA at 5 CFR 1320.3(b)(2). specific information (CAMH, Standard hospitals to have policies and The burden associated with IM.3.10, EP 5, CAMH Refreshed Core, procedures that will address the § 482.15(b)(3), (6), and (7) will be the January 2008, p. IM–10) and to ensure development of arrangements with other resources required to develop written the continuity of their critical hospitals or other providers to receive policies and procedures that comply information ‘‘needs for patient care, patients in the event of limitations or with the requirements. We expect that treatment, and services (CAMH, cessation of operations to ensure the risk management director will Standard IM.2.30, Rationale for IM.2.30, continuity of services to hospital review the hospital’s policies and CAMH Refreshed Core, January 2008, p. patients. TJC-accredited hospitals must procedures initially and make IM–8). They also must ensure the plan for the sharing of resources and privacy and confidentiality of patient assets with other healthcare recommendations for revisions and information (CAMH, Standard IM.2.10, organizations (CAMH, Standard development of additional policies or CAMH Refreshed Core, January 2008, p. EC.4.14, EPs 7 and 8, p. EC–13d). procedures. We expect that IM–7) and have plans for transporting However, we will not expect TJC- representatives from the hospital’s and tracking patients’ clinical accredited hospitals to be substantially major departments will make revisions information, including transferring in compliance with the requirements we or draft new policies and procedures information to ACSs (CAMH Standard proposed in § 482.15(b)(7) based on based on the administrator’s EC.4.14, EP 11, p. EC–13d and Standard compliance with TJC accreditation recommendation. The appropriate EC.4.18, EP 6, pp. EC–13d and EC–13g, standards alone. parties will then need to compile and respectively). Therefore, we expect that Section 482.15(b)(8) will require disseminate these new policies and TJC-accredited hospitals will be in hospitals to have policies and procedures. We estimate that complying compliance with the requirements we procedures that address the hospital’s with these requirements will require 17 proposed in § 482.15(b)(5). role under an ‘‘1135 waiver’’ (that is, a burden hours for each TJC-accredited Section 482.15(b)(6) will require waiver of some federal rules in hospital at a cost of $2,061. For all 3,448 hospitals to have policies and accordance with § 1135 of the Social TJC-accredited hospitals to comply with procedures that address the use of Security Act) in the provision of care these requirements will require an volunteers in an emergency or other and treatment at an ACS identified by estimated 58,616 burden hours (17 emergency staffing strategies, including emergency management officials. TJC- burden hours for each TJC-accredited the process and role for integration of accredited hospitals must already have hospital × 3,448 TJC-accredited state and federally-designated plans for transporting patients, as well hospitals) at a cost of $7,106,328 ($2,061 healthcare professionals to address as their associated information, estimated cost for each TJC-accredited surge needs during an emergency. TJC- medications, equipment, and staff to hospital × 3,448 TJC-accredited accredited hospitals must already define ACSs when the hospital cannot support hospitals).

TABLE 43—TOTAL COST ESTIMATE FOR A TJC-ACCREDITED HOSPITAL TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $172 2 $344 Risk Management Director ...... 104 4 416 Chief Medical Officer/Medical Director ...... 199 1 199

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TABLE 43—TOTAL COST ESTIMATE FOR A TJC-ACCREDITED HOSPITAL TO DEVELOP POLICIES AND PROCEDURES— Continued

Position Hourly wage Burden hours Cost estimate

Chief of Surgery ...... 231 1 231 Director of Nursing ...... 104 2 208 Pharmacy Director ...... 142 1 142 Facilities Director ...... 104 1 104 Health Information Services Director ...... 104 1 104 Security Manager ...... 104 1 104 Community Relations Manager ...... 107 1 107 Food Services Manager ...... 70 1 70 Medical Secretary ...... 32 1 32

Total ...... 17 2,061

The 1,345 non TJC-accredited the current policies and procedures, hospital at an estimated cost of $3,831. hospitals will need to review their suggest revisions, coordinate comments, Based on this estimate, for all 1,345 non policies and procedures, ensure that develop the policies and procedures, TJC-accredited hospitals to comply with their policies and procedures accurately and ensure that the necessary parties these requirements will require 44,385 reflect their risk assessments, emergency approve it. We expect that the hospital burden hours (33 burden hours for each preparedness plans, and communication administrator will spend more time non TJC-accredited hospital × 1,345 non plans, and incorporate any of our reviewing the policies and procedures TJC-accredited hospitals) at a cost of requirements into their policies and than most of the other individuals. $5,152,695 ($3,831 estimated cost for procedures. We expect that the risk We estimate that complying with this each non TJC-accredited hospital × management director will coordinate requirement will require 33 burden 1,345 non TJC-accredited hospitals). the meetings, review and comment on hours for each non TJC-accredited

TABLE 44—TOTAL COST ESTIMATE FOR A NON TJC-ACCREDITED HOSPITAL TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $172 3 $516 Risk Management Director ...... 104 10 1,040 Chief Medical Officer/Medical Director ...... 199 1 199 Chief of Surgery ...... 231 1 231 Director of Nursing ...... 104 6 624 Pharmacy Director ...... 142 2 284 Facilities Director ...... 104 3 312 Health Information Services Director ...... 104 1 104 Security Manager ...... 104 3 312 Community Relations Manager ...... 107 1 107 Food Services Manager ...... 70 1 70 Medical Secretary ...... 32 1 32

Total ...... 33 3,831

In addition, we expect that there will procedures, hospitals will also sustain a involvement of the hospital’s be a burden as a result of § 482.15(b)(7). burden related to developing the written administrator and risk management Section 482.15(b)(7) will require agreements related to those director. We also expect that a hospital hospitals to develop and maintain arrangements. attorney will assist with drafting the policies and procedures that address a All 4,793 hospitals will need to agreements and reviewing those hospital’s development of arrangements identify other hospitals and other documents for any legal implications. with other hospitals and other providers providers with which they could have We estimate that complying with this to receive patients in the event of agreements, negotiate and draft the requirement will require 8 burden hours agreements, and obtain all necessary limitations or cessation of operations to for each hospital at an estimated cost of authorizations for the agreements. For ensure continuity of services to hospital $1,037. Thus, it will require an the purpose of determining the burden, patients. We expect that hospitals will estimated 38,344 burden hours (8 we will assume that hospitals will have × base those arrangements on written written agreements with two other burden hours for each hospital 4,793 agreements between the hospital and hospitals and other providers. Based on hospitals) for all hospitals to comply other hospitals and other providers. our experience with hospitals, we with this requirement at a cost of Thus, in addition to the burden related expect that complying with this $4,970,341 ($1,037 estimated cost for × to developing the policies and requirement will primarily require the each hospital 4,793 hospitals).

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TABLE 45—TOTAL COST ESTIMATE FOR A HOSPITAL, WITH WRITTEN AGREEMENTS WITH OTHER HOSPITALS OR PROVIDERS, TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $172 2 $344 Risk Management Director ...... 104 3 312 Attorney ...... 127 3 381

Total ...... 8 1,037

Section 482.15(b) will also require with other healthcare providers to already have developed and are hospitals to review and update their ensure continuity of care for patients. currently maintaining emergency emergency preparedness policies and However, under this final rule, all communication plans that will satisfy procedures at least annually. We believe hospitals will need to review and the requirements contained in hospitals are already reviewing and update their plans to ensure compliance § 482.15(c). Therefore, we believe updating their emergency preparedness with our requirements. compliance with this requirement will policies and procedures periodically. TJC-accredited hospitals are required constitute a usual and customary Thus, we believe compliance with this to establish emergency communication business practice and will not be subject requirement will constitute a usual and strategies (CAMH, Standard EC.4.13, p. to PRA in accordance with the customary business practice for both EC–13b). In addition, TJC-accredited implementing regulations of the PRA at TJC-accredited and non TJC-accredited hospitals are specifically required to 5 CFR 1320.3(b)(2). hospitals and will not be subject to the ensure communication with staff, Most, if not all, non TJC-accredited PRA in accordance with the external authorities, patients, and their hospitals will be substantially in implementing regulations of the PRA at families (CAMH, Standard EC.4.13, EPs compliance with § 482.15(c)(1) through 5 CFR 1320.3(b)(2). Section 482.15(c) 1–5, p. EC–13c). TJC-accredited (4). However, non TJC-accredited will require each hospital to develop hospitals also are required to establish hospitals will need to review, update, and maintain an emergency ‘‘back-up communications systems and and in some cases, develop new preparedness communication plan that technologies’’ for such activities sections for their emergency complied with both federal and state (CAMH, Standard EC.4.13, EP 14, p. communication plans to ensure they are law. The plan will have to be reviewed EC–13c). Moreover, TJC-accredited in compliance with all of the and updated at least annually. The hospitals are required specifically to requirements in this section. We expect communication plan will have to define ‘‘the circumstances and plans for that this activity will require the include the information listed at communicating information about involvement of the hospital’s § 482.15(c)(1) through (7). patients to third parties (such as other administrator, the risk management We expect that all hospitals currently healthcare organizations) . . .’’ (CAMH, director, the facilities director, the have some type of emergency Standard EC.4.13, EP 12, p. EC–13c). health information services director, the preparedness communication plan. We Thus, we expect that that TJC-accredited security manager, and administrative expect that under this final rule, hospitals will be in compliance with support staff. We estimate that hospitals will review their current § 482.15(c)(1) through (4). In addition, complying with this requirement will communication plans, compare them to the rationale for EC.4.13 states, ‘‘the require 10 burden hours at a cost of their emergency preparedness plans and hospital maintains reliable surveillance $1,111 for each of the 1,345 non TJC- emergency policies and procedures, and and communications capability to accredited hospitals. Therefore, based revise their communication plans, as detect emergencies and communicate on this estimate, for non TJC-accredited necessary. It is standard practice for response efforts to hospital response hospitals to comply with this healthcare facilities to maintain contact personnel, patient and their families, requirement will require 13,450 burden information for staff and outside sources and external agencies (CAMH, Standard hours (10 burden hours for each non of assistance; have alternate means of EC.4.13, pp. EC–13b—13c). We expect TJC-accredited hospital × 1,345 non communication in case there is an that most, if not all, TJC-accredited TJC-accredited hospitals) at a cost of interruption in phone service to the hospitals will be in compliance with $1,494,295 ($1,068 estimated cost for facility; and have a method for sharing § 482.15(c)(5) through (7). Therefore, we each non TJC-accredited hospital × information and medical documentation expect that TJC-accredited hospitals 1,345 non TJC-accredited hospitals).

TABLE 46—TOTAL COST ESTIMATE FOR A NON TJC-ACCREDITED HOSPITAL TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $172 1 $172 Risk Management Director ...... 104 4 416 Director of Nursing ...... 104 1 104 Facilities Director ...... 104 1 104 Health Information Services Director ...... 104 1 104 Security Manager ...... 104 1 104 Community Relations Manager ...... 107 1 107

Total ...... 10 1,111

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Section 482.15(c) also will require elements the staff need before they as well as state and national healthcare hospitals to review and update their provide care, treatment, or services to associations and organizations. emergency preparedness patients (CAMH, Standard HR.2.10, EPs Hospitals could also participate in a communication plans at least annually. 1–2, CAMH Refreshed Core, January local healthcare coalition, a partnership We believe that hospitals are already 2008, p. HR–10). We will expect that an with other hospitals, healthcare reviewing and updating their emergency orientation to the hospital’s EOP will be facilities and local health departments preparedness communication plans part of this initial training. TJC- to develop the necessary training. In periodically. Therefore, we believe accredited hospitals also must provide addition, hospitals could develop compliance with this requirement will on-going training to their staff, partnerships with other hospitals and constitute a usual and customary including training on specific job- healthcare facilities to develop the business practice and will not be subject related safety (CAMH, Standard HR– necessary training. Some hospitals to the PRA in accordance with the 2.30, EP 4, CAMH Refreshed Core, might also choose to purchase off-the- implementing regulations of the PRA at January 2008, p. HR–11), and we expect shelf emergency training programs or 5 CFR 1320.3(b)(2). that emergency preparedness is part of hire consultants to develop the Section 482.15(d) will require such on-going training. programs for them. However, because hospitals to develop and maintain Although TJC requirements do not many hospitals have a hospital emergency preparedness training and specifically address training for emergency manager and safety office, testing programs and review and update individuals providing services under we anticipate that the training program those plans at least annually. The arrangement or training for volunteers would likely be developed using the hospital will be required to meet the consistent with their expected roles, it hospital’s own staff. It is our experience requirements in § 482.15(d)(1) and (2). is standard practice for healthcare with hospitals that a majority of them Section 482.15(d)(1) will require facilities to provide some type of conduct some type of preparedness hospitals to provide initial and training to all personnel, including activities and training and, as such, are thereafter annual training on their those providing services under contract most likely to have staff versed in these emergency preparedness policies and or arrangement and volunteers. If a issues that can assist with training. procedures to all and new existing staff, hospital does not already provide such Additionally, hospitals and other individuals providing services under training, we will expect the additional healthcare providers commonly arrangement, and volunteers, consistent burden to be negligible. Thus, for the participate in trainings that are provided TJC-accredited hospitals, the with their expected roles. Hospitals by their local healthcare coalition, local must also maintain documentation of all requirements will not be subject to the and state public health and emergency of this training. PRA in accordance with the management agencies conducting The burden for § 482.15(d)(1) will be implementing regulations of the PRA at community based exercises (for the time and effort necessary to develop 5 CFR 1320.3(b)(2). a training program and the materials Based on our experience with non example, American Red Cross). The needed for the required initial and TJC-accredited hospitals, we expect that estimation of a burden for these annual training. We expect that all the non TJC-accredited hospitals have requirements is based on this hospitals will review their current some type of emergency preparedness assumption. training programs and compare them to training program and provide training to Based on our experience with their risk assessments, emergency plans, their staff regarding their duties and hospitals, we expect that complying policies and procedures, and responsibilities under their emergency with this requirement will require the communication plans as set forth in plans. However, under this final rule, involvement of the hospital § 482.15(a)(1), (a), (b), and (c), non TJC-accredited hospitals will need administrator, the risk management respectively. Hospitals will need to to compare their existing training director, a healthcare trainer, and revise and, if necessary, develop new programs with their risk assessments, administrative support staff. We sections or material to ensure that their emergency preparedness plans, policies estimate that it will require 40 burden training programs comply with our and procedures, and communication hours for each hospital to develop an requirements. plans. They also will need to revise, emergency preparedness training TJC-accredited hospitals are required update, and, if necessary, develop new program at a cost of $3,000 for each non to define staff roles and responsibilities sections and new material for their TJC-accredited hospital. We estimate in their EOP and train their staff for training programs. that it will require 53,800 burden hours their assigned roles during emergencies There are many ways in which a (40 burden hours for each non TJC- (CAMH, EC.4.16, EPs 1–2, p. EC–13e). hospital may develop a training accredited hospital × 1,345 non TJC- In addition, the TJC-accredited hospitals program. For example, to develop their accredited hospitals) to comply with are required to provide an initial training programs, hospitals could draw this requirement at a cost of $4,035,000 orientation, which includes information upon the resources of federal, state, and ($3,000 estimated cost for each hospital that the hospital has determined are key local emergency preparedness agencies, × 1,345 non TJC-accredited hospitals).

TABLE 47—TOTAL COST ESTIMATE FOR A NON TJC-ACCREDITED HOSPITAL TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Administrator ...... $172 2 $344 Risk Management Director ...... 104 6 624 Healthcare Trainer (Registered Nurse) ...... 68 28 1,904 Medical Secretary ...... 32 4 128

Total ...... 40 3,000

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Section 482.15(d) will also require participated in a full-scale exercise, it emergency preparedness drills and hospitals to review and update their probably will not need to develop a exercises (Braun BI, Wineman NV, Finn emergency preparedness training scenario for that drill. However, for the NL, Barbera JA, Schmaltz SP, Loeb JM. program at least annually. We believe purpose of determining the burden, we Integrating hospitals into community that hospitals are already reviewing and will assume that hospitals will need to emergency preparedness planning. Ann updating their emergency preparedness develop at least two scenarios annually, Intern Med. 2006 Jun;144(11):799–811. training programs periodically. Thus, one for each testing exercise PubMed PMID: 16754922.) We also we believe compliance with this requirement. expect that many of these hospitals have requirement will constitute a usual and TJC-accredited hospitals are required already developed the required customary business practice and will to test their EOP twice a year (CAMH, documentation for recording the events, Standard EC.4.20, EP 1, p. EC–14a). In not be subject to the PRA in accordance and analyzing their responses to, their addition, TJC-accredited hospitals must with the implementing regulations of testing exercises and emergency events. the PRA at 5 CFR 1320.3(b)(2). analyze all exercises, identify Hospitals also will be required to deficiencies and areas for improvement, However, we do not believe that all non- maintain documentation of their and modify their EOPs in response to TJC accredited hospitals will be in training. Based on our experience, we the analysis of those tests (CAMH, compliance with our requirements. believe it is standard practice for Standard EC.4.20, EPs 15–17, p. EC– Thus, we will analyze the burden for hospitals to document the training they 14b). Therefore, we expect that TJC- non TJC-accredited hospitals. provide to their staff, individuals accredited hospitals have already The non TJC-accredited hospitals will providing services under arrangement, developed scenarios for testing exercises be required to develop scenarios for the and volunteers. Therefore, we believe and have the documentation needed for testing exercises and the documentation compliance with this requirement will the analysis of their responses. We necessary to record and analyze their constitute a usual and customary expect that it will be a usual and responses to the exercises and business practice for the hospitals and customary business practice for the TJC- emergency events. Based on our not be subject to the PRA in accordance accredited hospitals to comply with the experience with hospitals, we expect with the implementing regulations of requirement to prepare scenarios for that the same individuals who the PRA at 5 CFR 1320.3(b)(2). emergency preparedness testing developed the emergency preparedness Section 482.15(d)(2) will also require exercises and to develop the necessary training program will develop the hospitals to participate in a full-scale documentation. Thus, we believe scenarios for the testing exercises and exercise and one additional exercise of compliance with this requirement will the accompanying documentation. We their choice at least annually. Hospitals not be subject to the PRA in accordance expect that the healthcare trainer will also will be required to analyze their with the implementing regulations of responses to, and maintain the PRA at 5 CFR 1320.3(b)(2). spend more time developing the documentation of, all exercises and Based on our experience with non scenarios and documentation. Thus, for emergency events. If a hospital TJC-accredited hospitals, we expect that each of the 1,345 non TJC-accredited experienced an actual emergency which the remaining non TJC-accredited hospitals to comply with these required activation of its emergency hospitals have some type of emergency requirements, we estimate that it will plan, it will be exempt from the preparedness training program and that require 9 burden hours at a cost of $752. requirement for a community or most, if not all, of them already conduct Based on this estimate, for all 1,345 non individual, facility-based disaster drill some type of drill or exercise to test TJC-accredited hospitals to comply will for 1 year following the onset of the their emergency preparedness plans. In require 12,105 burden hours (9 burden emergency (§ 482.15(d)(2)(ii)). Thus, to addition, many hospitals participate in hours for each non TJC-accredited satisfy the burden for these drills and exercises held by their hospital × 1,345 non TJC-accredited requirements, hospitals will need to communities, counties, and states. A hospitals) at a cost of $1,011,440 ($752 develop a scenario for each exercise, as 2006 study of 678 hospitals found that estimated cost for each non TJC- well as the documentation necessary for 88 percent of the participating hospitals accredited hospital × 1,345 non TJC- recording what happened. If a hospital were engaged in community-wide accredited hospital).

TABLE 48—TOTAL COST ESTIMATE FOR A NON TJC-ACCREDITED HOSPITAL TO CONDUCT TESTING

Position Hourly wage Burden hours Cost estimate

Administrator ...... $172 1 $172 Risk Management Director ...... 104 2 208 Healthcare Trainer (RN) ...... 68 5 340 Medical Secretary ...... 32 1 32

Total ...... 9 752

TABLE 49—BURDEN HOURS AND COST ESTIMATES FOR ALL 4,793 HOSPITALS TO COMPLY WITH THE ICRS CONTAINED IN § 482.15 CONDITION: EMERGENCY PREPAREDNESS

Hourly labor OMB Burden per Total annual cost of Total labor Total cost Regulation section(s) Control No. Respondents Responses response burden reporting cost of reporting ($) (hours) (hours) ($) ($)

§ 482.15(a)(1) ...... 0938—New .... 1,345 1,345 36 45,730 ** 5,692,040.00 5,692,040.00 § 482.15(a)(1)–(4) ...... 0938—New .... 1,345 1,345 62 83,390 ** 9,963,760.00 9,963,760.00 § 482.15(b) ...... 0938—New .... 3,448 3,448 17 58,616 ** 7,106,328.00 7,106,328.00 (TJC-accredited) ......

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TABLE 49—BURDEN HOURS AND COST ESTIMATES FOR ALL 4,793 HOSPITALS TO COMPLY WITH THE ICRS CONTAINED IN § 482.15 CONDITION: EMERGENCY PREPAREDNESS—Continued

Hourly labor OMB Burden per Total annual cost of Total labor Total cost Regulation section(s) Control No. Respondents Responses response burden reporting cost of reporting ($) (hours) (hours) ($) ($)

§ 482.15(b) ...... 0938—New .... 1,345 1,345 33 44,385 ** 5,152,695.00 5,152,695.00 (Non TJC-accredited) ...... § 482.15(b)(7) ...... 0938—New .... 4,793 4,793 8 38,344 ** 4,970,341 4,970,341 § 482.15(c) ...... 0938—New .... 1,345 1,345 10 13,450 ** 1,494,295.00 1,494,295.00 § 482.15(d)(1) ...... 0938—New .... 1,345 1,345 40 53,800 ** 4,035,000.00 4,035,000.00 § 482.15(d)(2) ...... 0938—New .... 1,345 1,345 9 12,105 ** 1,011,440.00 1,011,440.00

Totals ...... 9,586 16,311 ...... 349,820 ...... 39,425,899.00 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 49.

I. ICRs Regarding Condition of for long term care (LTC) facilities. We included in Table 128 ‘‘Total Burden Participation: Emergency Preparedness would usually be required to estimate Hour Estimates for All Providers and for Transplant Centers (§ 482.78) the information collection requirements Suppliers to Comply with the ICRs As discussed in section II.I. of this (ICRs) for these requirements in Contained in the Final Rule: Emergency final rule, we have revised our accordance with chapter 35 of title 44, Preparedness’’, per the wavier discussed requirements for transplant centers. United States Code. However, sections previously. Emergency preparedness Section 482.78 will require that 4204(b) and 4214(d), which cover plan that must be reviewed and updated transplant programs be included in the skilled nursing facilities (SNFs) and at least annually. The plan will have to nursing facilities (NFs), respectively, of meet the requirements set out at emergency preparedness planning and the Omnibus Budget Reconciliation Act § 483.73(a)(1) through (4). the emergency preparedness program of 1987 (OBRA ’87) provide for a waiver Section 483.73(a)(1) requires LTC for the hospital in which it is located. of PRA requirements for the regulations facilities to develop documented, We note that a transplant center is not that implement the OBRA ’87 facility-based and community-based- individually responsible for the requirements. Section 1819(d) of the risk assessments utilizing an all-hazards emergency preparedness requirements Act, as implemented by section 4201 of approach. We expect that all LTC set forth in § 482.15, except as detailed. OBRA ’87, requires that SNFs ‘‘be facilities will need to identify the Section 482.78(a) will require transplant administered in a manner that enables medical and non-medical emergency centers to have policies and procedures it to use its resources effectively and events they could experience in their that address emergency preparedness. efficiently to attain or maintain the facilities themselves and the Section 482.78(b) will require transplant highest practicable physical, mental, communities in which they are located. centers to develop and maintain and psychosocial well-being of each We expect that in performing a risk mutually-agreed upon protocols that resident (consistent with requirements assessment, a LTC facility will need to address the duties and responsibilities established under subsection (f)(5)).’’ consider its physical location, the of the transplant center, the hospital in Section 1819(f)(5)(C) of the Act, requires geographic area in which it is located, which the transplant center is located, the Secretary to establish criteria for and its resident population. and the OPO during an emergency. assessing a SNF’s compliance with the The burden associated with this All of the Medicare-approved requirement in subsection (d) with requirement will be the time and effort transplant centers are located within respect for disaster preparedness. necessary to perform a thorough risk hospitals and, as part of the hospital, Nursing facilities have the same assessment that complies with the should be included in the hospital’s requirement in sections 1919(d) and requirements of this final rule. Existing emergency preparedness plans. We (f)(5)(C) of the Act, as implemented by requirements for LTC facilities already expect that since transplants are part of OBRA ’87. mandate that LTC facilities have the hospital, they are usually involved All of the requirements in this rule ‘‘detailed written plans and procedures in the hospital’s programs as part of relate to disaster preparedness. We to meet all potential emergencies and their normal business practices. Thus, believe this waiver applies to those disasters, such as fire, severe weather, compliance with these requirements revisions we have made to existing and missing residents’’ (see existing will constitute a usual and customary requirements in part 483, subpart B. § 483.75(m)(1)). We expect that all LTC business practice and will not be subject Thus, the ICRs for the requirements in facilities already have performed some to the PRA in accordance with the § 483.73 are not subject to the PRA. type of risk assessment during the implementing regulations of the PRA at However, the waiver does not apply to process of developing their emergency 5 CFR 1320.3(b)(2). We refer readers to the requirements of Executive Orders and/or disaster plans and procedures. the discussion in section H above 12866 and 13563 under the Regulatory However, these risk assessments may regarding the burden estimate for Impact Analysis (RIA) section. not be as thorough as we require in this hospitals. Therefore, to provide readers with final rule, nor address all of the J. ICRs Regarding Emergency sufficient context regarding the RIA elements required by § 483.73(a)(1). Preparedness (§ 483.73) discussion of the estimated costs to LTC With the exception of severe weather, facilities associated with this final rule, the existing requirements at 1. Discussion of Omnibus Budget we have provided a discussion of the § 483.75(m)(1) discussed previously Reconciliation Act of 1987 Waiver ICRs for LTC facilities in this COI address emergencies and disasters that Section 483.73 sets forth the section. We note that the estimates primarily arise within, or closely emergency preparedness requirements discussed in this section are not surrounding, a LTC facility. In addition,

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the existing regulations do not from, all of their major departments. suggested revisions, coordinate specifically require LTC facilities to Based on our experience with LTC comments, develop a new risk plan for man-made disasters. Therefore, facilities, we expect that reviewing, assessment, and ensure that the we expect that under this final rule, all revising, and updating a facility’s necessary parties approve the new risk LTC facilities will need to conduct a existing risk assessment will require the assessment. Therefore, we expect that review of their current risk assessments involvement of the LTC facility’s the administrator will spend more time and then perform the necessary tasks to administrator, director of nursing, and than the other participants working on ensure that their risk assessments the facilities director. We expect that the risk assessment. comply with the requirements. these individuals will attend an initial We have not identified any specific meeting, review relevant sections of the We estimate that complying with this process or format for LTC facilities to previous assessment, if any, develop requirement will require 8 burden hours use in conducting their risk assessments comments and recommendations, attend at a cost of $692. There are 15,699 LTC because we believe that they need a follow-up meeting, perform a final facilities in the United States. Therefore, maximum flexibility in determining the review along with the administrator, it will require an estimated 125,592 best way for their facilities to and approve the new risk assessment. burden hours (8 burden hours for each accomplish this task. However, we In addition, we expect that the LTC facility × 15,699 LTC facilities) for expect that in the process of developing administrator will likely coordinate the all LTC facilities to comply with this a risk assessment, healthcare meetings, perform an initial review of requirement at a cost of $10,863,708 institutions should include the current risk assessment, provide a ($692 estimated cost for each LTC representatives from, or obtain input critique of the risk assessment, offer facility × 15,699 LTC facilities).

TABLE 50—TOTAL COST ESTIMATE FOR A LTC FACILITY TO DEVELOP A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $85.00 4 $340.00 Director of Nursing ...... 85.00 2 170.00 Facilities Director ...... 91.00 2 182.00

Totals ...... 8 692.00

After conducting the risk assessment, revised risk assessments, and update, emergency preparedness plan, develop each LTC facility will then have to revise, and, if necessary, develop new comments and recommendations, attend develop and maintain an emergency sections for their plans to ensure their a follow-up meeting, perform a final preparedness plan that addresses the emergency plans address the risks review, and approve the new emergency requirements in § 483.73(a)(1)–(4) and identified in their risk assessments and preparedness plan. We expect that the review and update this plan at least the specific elements we are issuing in administrator will develop the annually. Existing requirements for LTC this final rule. emergency preparedness plan and facilities require them to have ‘‘detailed The burden associated with this ensure that the necessary parties written plans and procedures to meet all requirement will be the resources approved it. We also expect that the potential emergencies and disasters’’ needed to review, revise, and, if needed, administrator will spend more time than (see existing § 483.75(m)(1)). We expect develop new sections for the LTC the other participants reviewing and all LTC facilities already have some type facility’s existing emergency plan. Based working on the emergency preparedness of emergency preparedness and/or upon our experience with LTC facilities, plan. disaster plan. However, as discussed we expect that the same individuals We estimate that complying with this previously, we expect these plans and who were involved in the risk requirement will require 12 burden procedures will primarily cover assessment will be involved in these hours at a cost of $1,038 for each LTC disasters and emergencies that will activities. We also expect these tasks facility. There are 15,699 LTC facilities. affect the facilities themselves and, with will require more time to complete than Therefore, it will require an estimated the exception of severe weather, not the risk assessment. 188,388 burden hours (12 burden hours necessarily the communities in which We expect that the administrator, for each LTC facility × 15,699 LTC they are located. We also expect that all director of nursing, and the facilities facilities) to complete the plan at a cost LTC facilities will need to review their director will have to attend an initial of $ ($1,038 estimated cost for each LTC current plans, compare them to their meeting, review the facility’s current facility × 15,699 LTC facilities).

TABLE 51—TOTAL COST ESTIMATE FOR A LTC FACILITY TO DEVELOP AN EMERGENCY PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $85.00 6 $510.00 Director of Nursing ...... 85.00 3 255.00 Facilities Director ...... 91.00 3 273.00

Totals ...... 12 1,038.00

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We require LTC facilities to review procedures at least annually. These necessary to review, revise, and, if and update their emergency policies and procedures will have to necessary, develop new emergency preparedness plans at least annually. address, at a minimum, the policies and procedures. We expect that The current emergency preparedness requirements set forth at § 483.73(b)(1) the administrator, the director of requirements for LTC facilities mandate through (8). nursing, and the facilities director will that they ‘‘periodically review the We expect that all LTC facilities have be involved with reviewing, revising, procedures with their existing staff’’ some emergency preparedness policies and, if needed, developing any new (§ 483.75(m)(2)). We also expect that all and procedures in place because policies and procedures. The LTC facilities will review and update existing regulations require them to administrator will brief any other staff their emergency preparedness plans have written disaster and emergency and create assignments for purposes of preparedness plans and procedures that annually. Thus, compliance with this making necessary revisions or drafting address all potential disasters and requirement will constitute a usual and new policies and procedures and customary business practice for LTC emergencies (see exiting § 483.75(m)(1)). disseminate them to the appropriate facilities and will not be subject to the However, under this final rule, all LTC parties. We estimate that complying PRA in accordance with 5 CFR facilities will need to review their 1320.3(b)(2). policies and procedures, assess whether with this requirement will require 10 Section 483.73(b) requires each LTC their policies and procedures burden hours at a cost of $868. facility to develop and maintain incorporate all the elements of their Therefore, for all LTC facilities to emergency preparedness policies and emergency preparedness plan, and if comply with this requirement will procedures based on their emergency necessary, take the appropriate steps to require an estimated 156,990 burden preparedness plan, risk assessment, and ensure that their policies and hours (10 burden hours for each LTC communication plan as set forth at procedures encompass the requirements facility × 15,699 LTC facilities) at a cost § 483.73(a), (a)(1), and (c), respectively. in this final rule. of $13,626,732 ($868 estimated cost for LTC facilities are also required to review The burden associated with these each LTC facility × 15,699 LTC and update these policies and requirements will be the time and effort facilities).

TABLE 52—TOTAL COST ESTIMATE FOR A LTC FACILITY TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $85.00 4 $340.00 Director of Nursing ...... 85.00 3 255.00 Facilities Director ...... 91.00 3 273.00

Totals ...... 10 868.00

LTC facilities will be required to We expect that all LTC facilities will not be in compliance with the elements review and update their emergency have some type of emergency required in § 483.73(c)(4) through (7). preparedness policies and procedures at preparedness communication plan. Therefore, we expect that under this least annually. We believe that LTC Existing requirements for LTC facilities final rule, all LTC facilities will need to facilities already review their policies already require them to have written review, update, and in some cases, and procedures periodically. Hence, disaster plans and procedures (see develop new sections for their these activities will constitute a usual existing § 483.75(m)(1)). Since the emergency communication plans, to and customary business practice for ability to communicate with staff, ensure those plans include all of these LTC facilities and will not be subject to residents’ families, and external sources elements. of assistance during an emergency is the PRA in accordance with 5 CFR The burden associated with 1320.3(b)(2). critical for all healthcare organizations, we believe that communication will be complying with this requirement will be Section 483.73(c) will require each an integral part of any LTC facility’s the resources needed to review, update, LTC facility to develop and maintain an disaster plan. In addition, it is standard and, if necessary, develop new sections emergency preparedness practice for healthcare organizations to for the LTC facility’s existing communication plan that complied with maintain contact information for their communication plans. Based upon our both federal and state law. The LTC staff and for outside sources of experience with LTC facilities, we facility will also have to review and assistance; alternate means of expect that satisfying the requirements update its plan at least annually. The communications in case there is a of this section will require the communication plan will have to disruption in phone service to the involvement of the LTC facility’s include the information listed in facility; and a method for sharing administrator and the director of § 483.73(c)(1) through (7). information and medical documentation nursing. We estimate that complying We expect that all LTC facilities will with other healthcare providers to with this requirement will require 6 compare their current emergency ensure continuity of care for their burden hours for each facility at a cost preparedness communications plans, if residents. Thus, we expect that all LTC of $510. For all LTC facilities to comply they have one, to these requirements. facilities already comply with the with this requirement will require an The LTC facilities will then need to requirements of § 483.73(c)(1) through estimated 94,194 burden hours (6 perform any tasks necessary to ensure (3). However, we also expect that many burden hours for each LTC facility × that their communication plans were LTC facilities may not have formal, 15,699 LTC facilities) at a cost of documented and in compliance with written emergency preparedness $8,006,490 ($510 estimated cost for each these requirements. communication plans or their plans may LTC facility × 15,699 LTC facilities).

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TABLE 53—TOTAL COST ESTIMATE FOR A LTC FACILITY TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $85.00 3 $255.00 Director of Nursing ...... 85.00 3 255.00

Totals ...... 6 510.00

LTC facilities will also have to review Thereafter, each LTC facility will have The burden associated with and update its emergency preparedness to provide the training at least annually. complying with this requirement will be communication plan at least annually. Existing requirements for LTC the time and effort necessary for a LTC We believe that LTC facilities already facilities require facilities to ‘‘train all facility to compare its current review and update their plans and employees in emergency procedures emergency preparedness training procedures periodically. Thus, the when they begin to work in the facility’’ program’s contents to its updated requirement for an annual review of the and ‘‘periodically review the procedures emergency preparedness plan, risk emergency preparedness with existing staff’’ (See existing assessment, policies and procedures, communications plan constitutes a § 483.75(m)(2)). Therefore, we expect and communication plan and then usual and customary business practice that LTC facilities already provide some review, revise, and, if necessary, for LTC facilities and will not be subject type of emergency preparedness training develop new sections for its training to the PRA in accordance with 5 CFR program for new employees, as well as program to ensure that it complies with 1320.3(b)(2). ongoing training for all staff. However, the requirements of this final rule. We Section 483.73(d) will require LTC to ensure compliance with the believe that these activities will require facilities to develop and maintain requirements of this final rule, all LTC the involvement of an administrator and emergency preparedness training and facilities will need to review their the director of nursing. We expect that testing programs. These training and current training programs to ensure that testing programs will have to be the director of nursing will likely spend they met all of the requirements in this reviewed and updated at least annually. more time than the administrator final rule. LTC facilities will have to comply with working on the training program. We the requirements in § 483.73(d)(1) and Each LTC facility will need to estimate that complying with this (2). compare its current emergency requirement will require 10 burden With respect to § 483.73(d)(1), each preparedness training program’s hours for each LTC facility at an LTC facility will have to provide initial contents to its updated emergency estimated cost of $850. For all 15,699 training in emergency preparedness preparedness plan, risk assessment, LTC facilities to comply with this policies and procedures to all new and policies and procedures, and requirement, it will require an estimated existing staff, individuals providing communication plan and then review, 156,990 burden hours (10 burden hours services under arrangement, and revise, and, if necessary, develop new for each LTC facility × 15,699 LTC volunteers, consistent with their sections for its training program to facilities) at a cost of $13,344,150 ($850 expected roles, and maintain ensure that it complied with these estimated cost for each LTC facility × documentation of that training. requirements. 15,699 LTC facilities).

TABLE 54—TOTAL COST ESTIMATE FOR A LTC FACILITY TO CONDUCT TRAINING

Position Hourly wage Burden hours Cost estimate

Administrator ...... $85.00 2 $170.00 Director of Nursing ...... 85.00 8 680.00

Totals ...... 10 850

Each LTC facility will be required to will also have to analyze their responses and analyze their response to all testing review and update its emergency to, and maintain documentation of all exercises and emergency events. preparedness training program at least exercises and emergency events. If a Existing requirements for LTC annually. We believe that LTC facilities LTC facility experienced an actual facilities already mandate that these already review and update their training emergency which required activation of facilities ‘‘periodically review the programs periodically. Thus, its emergency plan, the LTC facility will procedures with existing staff, and carry compliance with this requirement will be exempt from the requirement for a out unannounced staff drills’’ constitute a usual and customary community or individual, facility-based (§ 483.75(m)(2)). We expect that all LTC business practices for LTC facilities and disaster exercise for 1 year following the facilities are already developing and will not be subject to the PRA in onset of the actual event conducting drills or exercises for their accordance with 5 CFR 1320.3(b)(2). (§ 483.73(d)(2)(ii)). disaster plans. It is also standard Section 483.73(d)(2) will require LTC To comply with these testing practice in the healthcare industry to facilities to participate in a full-scale requirements, a LTC facility will need to document what happens during a drill, exercise at least annually. LTC facilities develop a scenario for each exercise. A exercise, or emergency event and are also required to participate in one LTC facility will also need to develop analyze the facility’s response to those additional testing exercise of their the necessary documentation to record events. However, the LTC facility choice at least annually. LTC facilities requirements do not specify how often

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the facility must conduct a drill or the To comply with these requirements We estimate that these tasks will require type of drills. For purposes of determine we expect it will mainly require the 5 burden hours at a cost of $425. Based the burden associated with the testing involvement of the director of nursing. on this estimate, it will require 78,495 requirements in this final rule, we will We expect that the director of nursing burden hours (5 burden hours for each assume that all LTC facilities will need will develop the required LTC facility × 15,699 LTC facilities) for to develop scenarios for their testing documentation, as well as the scenarios all 15,699 LTC facilities to comply with exercises and the documentation for the testing exercises. We expect that these requirements at a cost of necessary to record the events during the administrator will provide some $6,672,075 ($425 estimated cost for each the testing exercises. assistance and approve the scenarios. LTC facility × 15,699 LTC facilities).

TABLE 55—TOTAL COST ESTIMATE FOR A LTC FACILITY TO CONDUCT TRAINING EXERCISES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $85.00 1 $85.00 Director of Nursing ...... 85.00 4 340.00

Totals ...... 5 425

TABLE 56—BURDEN HOURS AND COST ESTIMATES FOR ALL 15,699 LTC FACILITIES TO COMPLY WITH THE ICRS CONTAINED IN § 483.73 EMERGENCY PREPAREDNESS

Hourly labor Total labor OMB Number of Number of Burden per Total annual cost of cost of Total cost Regulation section(s) Control No. respondents responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 483.73(a)(1) ...... 0938-New ...... 15,699 15,699 8 125,592 ** 10,863,708 10,863,708 § 483.73(a)(1)–(4) ...... 0938-New ...... 15,699 15,699 12 188,388 ** 16,295,562 16,295,562 § 483.73(b) ...... 0938-New ...... 15,699 15,699 10 156,990 ** 13,626,732 13,626,732 § 483.73(c) ...... 0938-New ...... 15,699 15,699 6 94,194 ** 8,006,490 8,006,490 § 483.73(d)(1) ...... 0938-New ...... 15,699 15,699 10 156,990 ** 13,344,150 13,344,150 § 483.73(d)(2) ...... 0938-New ...... 15,699 15,699 5 78,495 ** 6,672,075 6,672,075

Totals ...... 15,699 94,194 ...... 800,649 ...... 68,808,717 * *The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 56.

Comment: A commenter appreciated expect an ICF/IID to identify the expect that this requirement will be that OBRA ’87 provided for a waiver of medical and non-medical emergency sufficient to protect the health and PRA requirements. However, the events it could experience in the facility safety of clients during more commenter requested that we publish and the community in which it is widespread local, state, or national the anticipated burden that these located and determine the likelihood of emergencies. In addition, an ICF/IID requirements would impose on LTC the facility experiencing an emergency current risk assessment may not address facilities for their information. due to the identified hazards. In all of the elements required in Response: We appreciate the performing the risk assessment, we § 483.475(a). Therefore, all ICFs/IID will commenter’s request and have provided expect that an ICF/IID will need to have to conduct a thorough review of a discussion of the anticipated ICRs in consider its physical location, the their current risk assessments, if they this final rule. geographical area in which it is located, have them, and then perform the and its client population. necessary tasks to ensure that their risk K. ICRs Regarding Condition of The burden associated with this assessments comply with the Participation: Emergency Preparedness requirements of this section. (§ 483.475) requirement will be the time and effort necessary to perform a thorough risk We have not designated any specific Section 483.475(a) will require assessment. The current CoPs for ICFs/ process or format for ICFs/IID to use in intermediate care facilities for IID already require ICFs/IID to ‘‘develop conducting their risk assessments individuals with intellectual disabilities and implement detailed written plans because we expect ICFs/IID will need (ICF/IID) to develop and maintain an and procedures to meet all potential maximum flexibility in determining the emergency preparedness plan that will emergencies and disasters such as fires, best way for their facilities to have to be reviewed and updated at severe weather, and missing clients’’ (42 accomplish this task. However, we least annually. We proposed that the CFR 483.470(h)(1)). During the process expect that in the process of developing plan will include the elements set out of developing these detailed written a risk assessment, an ICF/IID will at § 483.475(a)(1) through (4). We will plans and procedures, we expect that all include representatives from, or obtain discuss the burden for these activities ICFs/IID have already performed some input from, all of the major departments individually beginning with the risk type of risk assessment. However, as in their facilities. Based on our assessment. discussed earlier in the preamble, the experience with ICFs/IID, we expect Section 483.475(a)(1) will require current requirement is primarily that conducting the risk assessment will each ICFs/IID to develop a documented, designed to ensure the health and safety require the involvement of the ICF/IID facility-based and community-based risk of the ICF/IID clients during administrator and a professional staff assessment utilizing an all-hazard emergencies that are within the facility person, such as a registered nurse. We approach, including missing clients. We or in the facility’s local area. We do not expect that both individuals will attend

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an initial meeting, review relevant risk assessment, offer suggested to complete at a cost of $657. There are sections of the current assessment, revisions, coordinate comments, currently 6,237 ICFs/IID. Therefore, it develop comments and develop the new risk assessment, and will require an estimated 49,896 burden recommendations for changes to the assure that the necessary parties hours (8 burden hours for each ICF/IID assessment, attend a follow-up meeting, approve the new risk assessment. We × 6,237 ICFs/IID) for all ICFs/IID to perform a final review, and approve the also expect that the administrator will comply with this requirement at a cost risk assessment. We expect that the spend more time reviewing and working of $4,097,709 ($657 estimated cost for administrator will coordinate the on the risk assessment. Thus, we each ICF/IID × 6,237 ICFs/IID). meetings, perform an initial review of estimate that complying with this the current risk assessment, critique the requirement will require 8 burden hours

TABLE 57—TOTAL COST ESTIMATE FOR AN ICF/IID TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $93 5 $465 Registered Nurse ...... 64 3 192

Total ...... 8 657

Under this final rule, ICFs/IID will be including delegation of authority and developing the facility’s new emergency required to develop emergency succession plans. Thus, we expect that preparedness plan. We also expect that preparedness plans that addressed the each ICFs/IID will have to review its developing the plan will be more labor emergency events that could affect not current plans and compare them to its intensive and will require more time to only their facilities but also the risk assessments. Each ICF/IID will then complete than the risk assessment. We communities in which they are located. need to update, revise, and, in some estimate that it will require 9 burden An ICF/IID current disaster plan might cases, develop new sections to comply hours at a cost of $750 for each ICF/IID not address all of the medical and non- with our requirements. to develop an emergency plan that The burden associated with this medical emergency events identified by complied with the requirements in this requirement will be the resources its risk assessment, include strategies for section. Based on this estimate, it will needed to review, revise, and develop addressing those emergency events, or require 56,133 burden hours (9 burden new sections for an existing emergency × address its patient population. It may plan. Based upon our experience with hours for each ICF/IID 6,237 ICFs/IID) not specify the type of services the ICF/ ICFs/IID, we expect that the same to complete the plan at a cost of IID has the ability to provide in an individuals who were involved in the $4,677,750 ($750 estimated cost for each × emergency, or continuity of operations, risk assessment will be involved in ICF/IID 6,237 ICFs/IID).

TABLE 58—TOTAL COST ESTIMATE FOR AN ICF/IID TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $93 6 $558 Registered Nurse ...... 64 3 192

Total ...... 9 750

The ICF/IID also will be required to procedures at least annually. At a that all ICFs/IID already have review and update its emergency minimum, the ICF/IID policies and procedures that comply with some of preparedness plan at least annually. We procedures will be required to address the other requirements in this section. believe that ICFs/IID already review the requirements listed at For example, as will be discussed later, their emergency preparedness plans § 483.475(b)(1) through (8). current regulations require ICFs/IID to periodically. Thus, we believe We expect all ICFs/IID to compare perform drills, evaluate the effectiveness compliance with this requirement will their current emergency preparedness of those drills, and take corrective constitute a usual and customary policies and procedures to their action for any problems they detect emergency preparedness plans, risk business practice and will not be subject (§ 483.470(i)). We expect that all ICFs/ assessments, and communication plans. to the PRA in accordance with the IID have developed procedures for safe They will then need to revise and, if implementing regulations of the PRA at evacuation from and return to the ICF/ 5 CFR 1320.3(b)(2). necessary, develop new policies and procedures to ensure they comply with IID (§ 483.475(b)(4)) and a process to Section 483.475(b) will require each the requirements in this section. document and analyze drills and revise ICF/IID to develop and implement We expect that all ICFs/II already their emergency plan when they detect emergency preparedness policies and have some emergency preparedness problems. procedures, based on its emergency plan policies and procedures. As discussed We expect that each ICF/IID will need set forth in paragraph (a), the risk earlier, the current CoPs for ICFs/IID to review its current disaster policies assessment at paragraph (a)(1), and the require them to have ‘‘written . . . and procedures and assess whether they communication plan at paragraph (c). procedures to meet all potential incorporate all of the elements we are We will also require the ICF/IID to emergencies and disasters’’ proposing. Each ICF/IID also will need review and update these policies and (§ 483.470(h)(1)). In addition, we expect

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to revise, and, if needed, develop new procedures complied with the 6,237 ICFs/IID to comply with this policies and procedures. requirements of this section. We expect requirement will require 56,133 burden The burden incurred by reviewing, that these tasks will involve the ICF/IID hours (9 burden hours for each ICF/IID revising, updating and, if necessary, administrator and a registered nurse. We × 6,237 ICFs/IID) at a cost of $4,677,750 developing new emergency policies and estimate that for each ICF/IID to comply ($750 estimated cost for each ICF/IID × procedures will be the resources needed will require 9 burden hours at a cost of 6,237 ICFs/IID). to ensure that the ICF/IID policies and $750. Based on this estimate, for all

TABLE 59—TOTAL COST ESTIMATE FOR AN ICF/IID TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $93 6 $558 Registered Nurse ...... 64 3 192

Total ...... 9 750

We expect ICFs/IID to review and section. The ICFs/IID also will need to clients. However, many ICFs/IID may update their emergency preparedness perform any tasks necessary to ensure not have a formal, written emergency policies and procedures at least that they document their preparedness communication plan, or annually. We believe that ICFs/IID communication plans and that those their plan may not comply with all the already review their policies and plans comply with the requirements of elements we are requiring. procedures periodically. Thus, we this section. The burden associated with believe compliance with this We expect that all ICFs/IID have some complying with this requirement will be requirement will constitute a usual and type of emergency preparedness the resources required to ensure that the customary business practice and will communication plan. The current CoPs ICF/IID emergency communication plan not be subject to the PRA in accordance require ICFs/IID to have written disaster with the implementing regulations of plans and procedures for all potential complied with the requirements. Based the PRA at 5 CFR 1320.3(b)(2). emergencies (§ 483.470(h)(1)). We upon our experience with ICFs/IID, we Section 483.475(c) will require each expect that an integral part of these anticipate that meeting the requirements ICF/IID to develop and maintain an plans and procedures will include in this section will primarily require the emergency preparedness communication. Furthermore, it is involvement of the ICF/IID communication plan that complied with standard practice for healthcare administrator and a registered nurse. We both federal and state law. The ICF/IID organizations to maintain contact estimate that for each ICF/IID to comply will also have to review and update the information for both staff and outside with the requirement will require 6 plan at least annually. The sources of assistance; have alternate burden hours at a cost of $500. communication plan must include the means of communication in case there Therefore, for all 6,237 ICFs/IID to information set out at § 483.475(c)(1) is an interruption in phone service to comply with this requirement will through (7). the facility (for example, cell phones); require an estimated 37,442 burden We expect all ICFs/IID to compare and have a method for sharing hours (6 burden hours for each ICF/IID their current emergency preparedness information and medical documentation × 6,237 ICFs/IID) at a cost of $3,118,500 communications plans, if they have with other healthcare providers to ($500 estimated cost for each ICF/IID × them, to the requirements in this ensure continuity of care for their 6,237 ICFs/IID).

TABLE 60—TOTAL COST ESTIMATE FOR AN ICF/IID TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $93 4 $372 Registered Nurse ...... 64 2 128

Total ...... 6 500

The ICFs/IID will also have to review preparedness training and testing documentation of the training. and update their emergency programs that will have to be reviewed Thereafter, the ICF/IID will have to preparedness communication plans at and updated at least annually. Each ICF/ provide emergency preparedness least annually. We believe that ICFs/IID IID will also have to meet the training at least annually. already review their plans, policies, and requirements for evacuation drills and The ICFs/IID will need to compare procedures periodically. Thus, we training at § 483.470(i). their current emergency preparedness believe compliance with this To comply with the requirements at training programs’ contents to their risk requirement will constitute a usual and § 483.475(d)(1), an ICF/IID will have to assessments and updated emergency customary business practice and will provide initial training in emergency preparedness plans, policies and not be subject to the PRA in accordance preparedness policies and procedures to procedures, and communication plans with the implementing regulations of all new and existing staff, individuals and then revise and, if necessary, the PRA at 5 CFR 1320.3(b)(2). providing services under arrangement, develop new sections for their training Section 483.475(d) will require ICFs/ and volunteers, consistent with their programs to ensure they complied with IID to develop and maintain emergency expected roles, and maintain the requirements. The current ICFs/IID

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CoPs require ICFs/IID to periodically Each ICF/IID also will need to revise section; accomplishing those tasks, and review and provide training to their staff and, if necessary, develop new sections developing an updated training on the facility’s emergency plan for their training program to ensure it program. We expect the administrator (§ 483.470(h)(2)). In addition, staff on all complied with the requirements. will work with the registered nurse to shifts must be trained to perform the The burden will be the time and effort update the training program. We tasks to which they are assigned for necessary to comply with the estimate that it will require 7 burden evacuations (§ 483.470(i)(1)(i)). We requirements. We expect that a hours for each ICF/IID to develop an expect that all ICFs/IID have emergency registered nurse will be primarily emergency training program at a cost of preparedness training programs for their involved in reviewing the ICF/IID $506. Therefore, it will require an staff. However, under this final rule, current training program and the ICF/ estimated 43,659 burden hours (7 each ICF/IID will need to review its IID updated emergency preparedness burden hours for each ICF/IID × 6,237 current training program and compare plan, policies, and procedures, and ICFs/IID) to comply with this its contents to its updated emergency communication plan; determining what requirement at a cost of $3,155,922 preparedness plan, policies and tasks will need to be performed to ($506 estimated cost for each ICF/IID × procedures, and communications plan. comply with the requirements of this 6,237 ICFs/IID).

TABLE 61—TOTAL COST ESTIMATE FOR AN ICF/IID TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Administrator ...... $93 2 $186 Registered Nurse ...... 64 5 320

Total ...... 7 506

The ICFs/IID will have to review and with this requirement, an ICF/IID will that scenarios are used for each drill or update their emergency preparedness need to develop scenarios for each tabletop exercise. For the purpose of training program at least annually. We testing exercise. An ICF/IID also will determining a burden for these believe that ICFs/IID already review have to develop the required requirements, all ICFs/IID will have to their emergency preparedness training documentation. develop scenarios and all ICFs/IID will programs periodically. Thus, we believe The current ICF/IID CoPs require have to develop the necessary compliance with this requirement will them to hold evacuation drills at least documentation. constitute a usual and customary quarterly for each shift and under varied The burden associated with these business practice and will not be subject conditions to evaluate the effectiveness requirements will be the resources the to the PRA in accordance with the of emergency and disaster plans and implementing regulations of the PRA at procedures (§ 483.470(i)(1)). In addition, ICF/IID will need to comply with the 5 CFR 1320.3(b)(2). ICFs/IID must ‘‘actually evacuate clients requirements. We expect that complying Section 483.475(d)(2) will require during at least one drill each year on with these requirements will likely ICFs/IID to participate in a full-scale each shift . . . file a report and require the involvement of a registered exercise and one additional exercise of evaluation on each evacuation drill . . . nurse. We expect that the registered their choice at least annually. The ICFs/ and investigate all problems with nurse will develop the required IID will also be required to analyze their evacuation drills, including accidents, documentation. We also expect that the responses to and maintain and take corrective action’’ (42 CFR registered nurse will develop the documentation of all testing exercises 483.470(i)(2)). Thus, all 6,450 ICFs/IID scenarios for the each testing exercise. and emergency events, and revise their already conduct quarterly drills. We estimate that these tasks will require emergency plans, as needed. If an ICF/ However, the current CoPs do not 4 burden hours at a cost of $256. Based IID experienced an actual natural or indicate the type of drills ICFs/IID must on this estimate, for all 6,237 ICFs/IID man-made emergency that required perform. In addition, although the CoPs to comply, it will require 24,948 burden activation of its emergency plan, the require that a report and evaluation be hours (4 burden hours for each ICF/IID ICF/IID will be exempt from engaging in filed, this requirement does not ensure × 6,237 ICFs/IID) at a cost of $1,596,672 a full-scale exercise for 1 year following that ICFs/IID have developed the type of ($256 estimated cost for each ICF/IID × the onset of the actual event. To comply paperwork we proposed requiring or 6,237 ICFs/IID).

TABLE 62—TOTAL COST ESTIMATE FOR AN ICF/IID TO CONDUCT TESTING

Position Hourly wage Burden hours Cost estimate

Registered Nurse ...... $64 4 $256

Total ...... 4 256

TABLE 63—BURDEN HOURS AND COST ESTIMATES FOR ALL 6,237 ICFS/IID TO COMPLY WITH THE ICRS CONTAINED IN § 485.475 CONDITION: EMERGENCY PREPAREDNESS

Total labor OMB Burden per Total annual Hourly labor cost of Total cost Regulation section(s) Control No. Respondents Responses response burden cost of reporting ($) (hours) (hours) reporting ($) ($)

§ 483.475(a)(1) ...... 6,237 6,237 8 49,896 ** 4,097,709 4,097,709

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TABLE 63—BURDEN HOURS AND COST ESTIMATES FOR ALL 6,237 ICFS/IID TO COMPLY WITH THE ICRS CONTAINED IN § 485.475 CONDITION: EMERGENCY PREPAREDNESS—Continued

Total labor OMB Burden per Total annual Hourly labor cost of Total cost Regulation section(s) Control No. Respondents Responses response burden cost of reporting ($) (hours) (hours) reporting ($) ($)

§ 483.475(a)(1)–(4) ...... 6,237 6,237 9 56,133 ** 4,677,750 4,677,750 § 483.475(b) ...... 6,237 6,237 9 56,133 ** 4,677,750 4,677,750 § 483.475(c) ...... 6,237 6,237 6 37,422 ** 3,118,500 3,118,500 § 483.475(d)(1) ...... 6,237 6,237 7 43,659 ** 3,155,922 3,155,922 § 483.475(d)(2) ...... 6,237 6,237 4 24,948 ** 1,596,672 1,596,672

Totals ...... 6,237 37,422 ...... 268,191 ...... 21,324,303 * *The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 63.

L. ICRs Regarding Condition of periodically by the individual states. describing the process for disaster Participation: Emergency Preparedness Due to variations in the timeliness of the readiness and emergency management (§ 484.22) data submissions, all numbers are . . . ’’ (CAMHC, Standard EC.4.10, EP 3, approximate, and the number of p. EC–9). In addition, TJC requires that Section 484.22(a) will require home accredited and non-accredited HHAs these plans provide for ‘‘processes for health agencies (HHAs) to develop and may not equal the total number of managing . . . activities related to care, maintain emergency preparedness HHAs. treatment, and services (for example, plans. Each HHA also will be required Section 484.22(a)(1) will require that scheduling, modifying, or discontinuing to review and update the plan at least HHAs develop a documented, facility- services; controlling information about annually. Specifically, we proposed that based and community-based risk patients; referrals; transporting patients) the plan meet the requirements listed at assessment utilizing an all-hazards . . . logistics relating to critical supplies § 484.22(a)(1) through (4). We will approach. To perform this risk . . . communicating with patient’’ discuss the burden for these activities assessment, an HHA will need to during an emergency (CAMHC, individually, beginning with the risk identify the medical and non-medical Standard EC.4.10, EP 10, p. EC–9–10). assessment. emergency events the HHA could We expect that any HHA that has Accreditation may substantially affect experience and how the HHA’s essential conducted a proactive risk assessment the burden a HHA will experience business functions and ability to and developed an emergency under this final rule. HHAs are provide services could be impacted by management plan that satisfies the accredited by three different accrediting those emergency events based on the previously described TJC accreditation organizations (AOs): The Joint risks to the facility itself and the requirements has already conducted a Commission (TJC), The Community community in which it is located. We risk assessment that will satisfy our Health Accreditation Program (CHAP), will expect HHAs to consider the extent requirements. Any tasks needed to and the Accreditation Commission for of their service area, including the comply with our requirements will not Health Care, Inc. (ACHC). After location of any branch offices. An HHA result in any additional burden. Thus, reviewing the accreditation standards with an existing risk assessment will for the 4,330 TJC-accredited HHAs, the for all three AOs, neither the standards need to review, revise and update it to risk assessment requirement will for CHAP nor the ones for ACHC comply with our requirements. constitute a usual and customary appeared to ensure substantial For TJC accreditation standards, we business practice and will not be subject compliance with our requirements in used TJC’s CAMHC Refreshed Core, to the PRA in accordance with the this rule. Therefore, the HHAs January 2008 pages from the implementing regulations of the PRA at accredited by CHAP and ACHC will be Comprehensive Accreditation Manual 5 CFR 1320.3(b)(2). included with the non-accredited HHAs for Home Care 2008 (CAMHC). In the It is standard practice for healthcare for the purposed of determining the chapter entitled, ‘‘Environmental Safety facilities to prepare for common internal burden for this final rule. and Equipment Management’’ (EC), TJC and external medical and non-medical As of June 2016, there are currently accreditation standards require HHAs to emergencies, based on their location, 12,335 HHAs. There are 4,330 TJC- conduct proactive risk assessments to structure, and the services they provide. accredited HHAs. A review of TJC ‘‘evaluate the potential adverse impact We believe that the 8,005 non TJC- deeming standards indicates that the of the external environment and the accredited HHAs have conducted some 4,330 TJC-accredited HHAs already services provided on the security of type of risk assessment. However, those perform certain tasks or activities that patients, staff, and other people coming risk assessments are unlikely to satisfy will partially or completely satisfy our to the organization’s facilities’’ all of our requirements. Therefore, we requirements. Therefore, since TJC (CAMHC, Standard EC.2.10, EP 3, p. will analyze the burden for the 8,005 accreditation is a significant factor in EC–7). These proactive risk assessments non TJC-accredited HHAs to comply. determining the burden, we will analyze should evaluate the risk to the entire We have not designated any specific the burden for the 4,330 TJC-accredited organization, and the HHA should process or format for HHAs to use in HHAs separately from the 8,005 non conduct one of these assessments conducting their risk assessments TJC-accredited HHAs (12,335 HHAs– whenever it identifies any new external because we believe that HHAs need the 4,330 TJC-accredited HHAs), as risk factors or begins a new service flexibility to determine the best way to appropriate. Note that we obtain data on (CAMHC, Standard EC.2.10, p. EC–7). accomplish this task. However, we the number of HHAs, both accredited Moreover, TJC-accredited HHAs are expect that HHAs will include and non-accredited, from the CMS required to develop and maintain ‘‘a representatives from or input from all of CASPER data system, which is updated written emergency management plan their major departments. Based on our

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experience working with HHAs, we expect that the director of nursing will a cost of $959. There are currently about expect that conducting the risk coordinate the meetings, review the 8,005 non TJC-accredited HHAs. We assessment will require the involvement current risk assessment, provide estimate that for all non TJC-accredited of an HHA administrator, the director of suggestions, coordinate comments, HHAs to comply with this requirement nursing, director of rehabilitation, and develop the new risk assessment, and will require 88,055 burden hours (11 the office manager. We expect that these ensure that the necessary parties burden hours for each non TJC- individuals will attend an initial approve it. We expect that the director accredited HHA × 8,005 non TJC- meeting, review relevant sections of the of nursing will spend more time accredited HHAs) at a cost of $7,676,795 current assessment, prepare and forward developing the facility’s new risk ($959 estimated cost for each non TJC- their comments to the administrator and assessment than the other individuals. accredited HHA × 8,005 non TJC- the director of nursing, attend a follow- We estimate that the risk assessment accredited HHAs). up meeting, perform a final review, and will require 11 burden hours for each approve the new risk assessment. We non TJC-accredited HHA to complete at

TABLE 64—TOTAL COST ESTIMATE FOR A NON TJC-ACCREDITED HHA TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 2 $194 Director of Nursing ...... 97 5 485 Director of Rehabilitation ...... 88 2 176 Office Manager ...... 52 2 104

Total ...... 11 959.00

After conducting a risk assessment, HHAs will incur some burden due to also will need to update, revise, and, in HHAs will have to develop an reviewing, revising, and in some cases, some cases, develop new sections for emergency preparedness plan that developing new sections for their their emergency plans. complied with § 484.22(a)(1) through emergency preparedness plans. Based on our experience with HHAs, (4). As discussed earlier, TJC already However, we will analyze the burden we expect that the same individuals has accreditation standards similar to for TJC-accredited HHAs separately who were involved in the risk the requirements we proposed at from the 8,005 non TJC-accredited assessment will be involved in § 484.22(a). Thus, we expect that TJC- HHAs because we expect the burden for accredited HHAs have an emergency TJC-accredited HHAs to be substantially developing the emergency preparedness preparedness plan that will satisfy most less. plan. We estimate that complying with of our requirements. Although the We expect that the 8,005 non TJC- this requirement will require 10 burden current HHA CoPs require that there be accredited HHAs already have some hours for each TJC-accredited HHA at a a qualified person who ‘‘is authorized in type of emergency preparedness plan, as cost of $862. Therefore, for all 4,330 writing to act in the absence of the well as delegations of authority and TJC-accredited HHAs to comply will administrator’’ (§ 484.14(c)), the TJC succession plans. However, we also require an estimated 43,300 burden standards do not specifically address expect that their plans do not comply hours (10 burden hours for each TJC- delegations of authority or succession with all of our requirements. Thus, all accredited HHA × 4,330 TJC-accredited plans. Furthermore, TJC standards do non TJC-accredited HHAs will need to HHAs) at a cost of $3,732,460 ($862 not address persons-at-risk. Therefore, review their current plans and compare estimated cost for each HHA × 4,330 we expect that the 1,815 TJC-accredited them to their risk assessments. They TJC-accredited HHAs).

TABLE 65—TOTAL COST ESTIMATE FOR A TJC-ACCREDITED HHA TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 2 $194 Director of Nursing ...... 97 4 388 Director of Rehabilitation ...... 88 2 176 Office Manager ...... 52 2 104

Total ...... 10 862

We estimate that complying with this accredited HHAs to comply will require $10,350,465 ($1,293 estimated cost for requirement will require 15 burden an estimated 120,075 burden hours (15 each non TJC-accredited HHA × 8,005 hours for each of the 8,005 non TJC- burden hours for each non TJC- non TJC-accredited HHAs). accredited HHAs at a cost of $1,293. accredited HHA × 8,005 non TJC- Therefore, for all 8,005 non TJC- accredited HHAs) at a cost of

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TABLE 66—TOTAL COST ESTIMATE FOR A NON-TJC ACCREDITED HHA TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 3 $291 Director of Nursing ...... 97 6 582 Director of Rehabilitation ...... 88 3 264 Office Manager ...... 52 3 156

Total ...... 15 1,293

Based on these estimates, for all emergency management plan that Existing HHA regulations already 12,335 HHAs to develop an emergency provides processes for managing address § 484.22(b)(1) and (2). For preparedness plan that complies with activities related to care, treatment, and example, regulations at § 484.18 make it our requirements will require 163,375 services, including scheduling, clear that HHAs are expected to accept burden hours at a cost of $14,082,925. modifying, or discontinuing services patients only on the basis of a We will also require HHAs to review (CAMHC, Standard EC.4.10, EP 10, EC– reasonable expectation that they can and update their emergency 9); identify backup communication provide for the patients’ medical, preparedness plans at least annually. systems in the event of failure due to an nursing, and social needs in the We believe that HHAs are already emergency event (CAMHC, Standard patients’ home. Moreover, the plan of reviewing and updating their emergency EC.4.10, EP 18, EC–10); and develop care for each patient must cover any preparedness plans periodically. Hence, processes for critiquing tests of its safety measures necessary to protect the we believe compliance with this emergency preparedness plan and patient from injury § 484.18(a). Thus, requirement will constitute a usual and modifying the plan in response to those the activities necessary to be in customary business practice for HHAs critiques (CAMHC, Standard EC.4.20, compliance with § 484.22(b)(1) and (2) and will not be subject to the PRA in EPs 15–17, p. EC–11). will constitute usual and customary accordance with the implementing We expect that the 4,330 TJC- business practices for HHA and will not regulations of the PRA at 5 CFR accredited HHAs already have be subject to the PRA in accordance 1320.3(b)(2). emergency preparedness policies and with the implementing regulations of Section 484.22(b) will require each procedures that address some of the the PRA at 5 CFR 1320.3(b)(2). HHA to develop and implement requirements at § 484.22(b). However, We expect that all 12,520 HHAs have emergency preparedness policies and we do not believe that TJC accreditation some emergency preparedness policies procedures based on the emergency requirements ensure that TJC-accredited and procedures. However, we also plan, risk assessment, communication HHAs’ policies and procedures address expect that all HHAs will need to plan as set forth in § 484.22(a), (a)(1), all of our requirements for emergency review their policies and procedures and (c), respectively. The HHA will also policies and procedures. Thus, we will and revise and, if necessary, develop have to review and update its policies include the 4,330 TJC-accredited HHAs new policies and procedures that and procedures at least annually. We with the 8,005 non TJC-accredited complied with our requirements set out will require that, at a minimum, these HHAs in our analysis of the burden for at § 484.22(3) through (6). We expect policies and procedures address the § 484.22(b). that a professional staff person, most requirements listed at § 484.22(b)(1) Under § 484.22(b)(1), the HHA’s likely the director of nursing, will through (6). individual plans for patients during a review the HHA’s policies and We expect that HHAs will review natural or man-made disaster will be procedures and make recommendations their emergency preparedness policies included as part of the comprehensive for changes or development of and procedures and compare them to patient assessment, which will be additional policies and procedures. The their risk assessments, emergency conducted according to the provisions administrator or director of nursing will preparedness plans, and emergency at § 484.55. We expect that HHAs brief representatives of most of the communication plans. HHAs will need already collect data during the HHA’s major departments and assign to revise or, in some cases, develop new comprehensive patient assessment that staff to make necessary revisions and policies and procedures to ensure they they will need to develop for each draft any new policies and procedures. complied with all of the requirements. patient’s emergency plan. At We estimate that complying with this In the chapter entitled, ‘‘Leadership,’’ § 484.22(b)(2), we proposed requiring requirement will require 18 burden TJC accreditation standards require that each HHA to have procedures to inform hours for each HHA at a cost of $1,584. each HHA’s ‘‘leaders develop policies state and local emergency preparedness Thus, for all 12,335 HHAs to comply and procedures that guide and support officials about HHA patients in need of with all of our requirements will require patient care, treatment, and services’’ evacuation from their residences at any an estimated 222,030 burden hours (18 (CAMHC, Standard LD.3.90, EP 1, p. time due to an emergency situation burden hours for each HHA × 12,335 LD–13). In addition, TJC accreditation based on the patients’ medical and HHAs) at a cost of $19,538,640 ($1,584 standards and EPs specifically require psychiatric condition and home estimated cost for each HHA × 12,335 each HHA to develop and maintain an environment. HHAs).

TABLE 67—TOTAL COST ESTIMATE FOR A HHA TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 4 $388 Director of Nursing ...... 97 8 776

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TABLE 67—TOTAL COST ESTIMATE FOR A HHA TO DEVELOP POLICIES AND PROCEDURES—Continued

Position Hourly wage Burden hours Cost estimate

Director of Rehabilitation ...... 88 3 264 Office Manager ...... 52 3 156

Total ...... 18 1,584

We are also proposing that HHAs interruption in phone service to the alternate means of communication, and review and update their emergency facility; and a method of sharing a method for sharing information with preparedness policies and procedures at information and medical documentation other healthcare facilities. However, this least annually. The current CoPs require with other healthcare providers to will not ensure that all HHAs will be in HHAs to establish and annually review ensure continuity of care for patients. compliance with our requirements for the agency’s policies governing scope of All TJC-accredited HHAs are required communication plans. Thus, we will services offered, admission and to identify backup communication analyze the burden for this requirement discharge policies, medical supervision systems for both internal and external for all 12,335 HHAs. and plans of care, emergency clinical communication in case of failure due to The burden associated with records and program evaluation. (42 an emergency (CAMHC, Standard CFR 484.16). Thus, we believe that EC.4.10, EP 18, p. EC–10). They are complying with this requirement will be complying with this requirement will required to have processes for notifying the time and effort necessary for each constitute a usual and customary their staff when the HHA initiates its HHA to review its existing business practice for HHAs and will not emergency plan (CAMHC, Standard communication plan, if any, and revise be subject to the PRA in accordance EC.4.10, EP 7, p. EC–9); identifying and it; and, if necessary, to develop new with the implementing regulations of assigning staff to ensure that essential sections for the emergency preparedness the PRA at 5 CFR 1320.3(b)(2). functions are covered during communication plan to ensure that it In § 484.22(c), each HHA will be emergencies (CAMHC, Standard complied with our requirements. Based required to develop and maintain an EC.4.10, EP 9, p. EC–9); and activities on our experience with HHAs, we emergency preparedness related to care, treatment, and services, expect that these activities will require communication plan that complied with such as controlling information about the involvement of the HHA’s both federal and state law. We proposed their patients (CAMHC, Standard administrator, director of nursing, that each HHA review and update its EC.4.10, EP 10, p. EC–9). However, we director of rehabilitation, and office communication plan at least annually. do not believe these requirements manager. We estimate that complying We will require that the emergency ensure that all TJC-accredited HHAs are with this requirement will require 10 communication plan include the already in compliance with our burden hours for each HHA at a cost of information listed at § 484.22(c)(1) requirements. Thus, we will include the $826. Thus, for all 12,335 HHAs to through (6). 4,330 TJC-accredited HHAs with the comply with these requirements will It is standard practice for healthcare 8,005 non TJC-accredited HHAs in require an estimated 123,350 burden facilities to maintain contact assessing the burden for this hours (10 burden hours for each HHA × information for both staff and outside requirement. 123,350 HHAs) at a cost of $10,188,710 sources of assistance; alternate means of We expect that all 12,335 HHAs ($826 estimated cost for each HHA × communication in case there is an maintain some contact information, an 123,350 HHAs).

TABLE 68—TOTAL COST ESTIMATE FOR A HHA TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 1 $97 Director of Nursing ...... 97 5 485 Director of Rehabilitation ...... 88.00 1 88 Office Manager ...... 52.00 3 156

Total ...... 10 826

We proposed requiring HHAs to require each HHA to develop and documentation of the training. review and update their emergency maintain an emergency preparedness Thereafter, the HHA will have to preparedness communication plans at training and testing program. Each HHA provide emergency preparedness least annually. We believe that HHAs will also have to review and update its training at least annually. Each HHA already review their emergency training and testing program at least will also have to ensure that their staff preparedness plans periodically. Thus, annually. Section 484.22(d)(1) states could demonstrate knowledge of their we believe compliance with this that each HHA will have to provide emergency procedures. requirement will constitute a usual and initial training in emergency Based on our experience with HHAs, customary business practice for HHAs preparedness policies and procedures to we expect that all 12,335 HHAs have and will not be subject to the PRA in all new and existing staff, individuals some type of emergency preparedness accordance with the implementing providing services under arrangement, training program because this a key regulations of the PRA at 5 CFR and volunteers, consistent with their component of emergency preparedness 1320.3(b)(2). Section 484.22(d) will expected roles, and maintain and as stated earlier, it is standard

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practice for healthcare facilities to However, we expect that under Based on our experience with HHAs, prepare for common internal and § 484.22(d), all HHAs will need to we expect that complying with this external medical and non-medical compare their training and testing requirement will require the emergencies, based on their location, programs with their risk assessments, involvement of an administrator, the structure, and the services they provide. emergency preparedness plans, director of training, director of nursing, The 4,330 TJC-accredited HHAs are emergency policies and procedures, and director of rehabilitation, and the office already required to provide both an emergency communication plans. We manager. We expect that the director of initial orientation to their staff before expect that most HHAs will need to training will spend more time they can provide care, treatment, or revise and, in some cases, develop new reviewing, revising or developing new services (CAMHC, Standard HR.2.10, EP sections for their training programs to sections for the training program than 2, p. HR–6) and ‘‘ongoing in-services, ensure that they complied with our the other individuals. We estimate that training or other staff activities [that] requirements. In addition, HHAs will it will require 16 burden hours for each emphasize job-related aspects of safety need to provide an orientation and HHA to develop an emergency . . .’’ (CAMHC, Standard HR.2.30, EP 4, annual training in their facilities’ preparedness training and testing p. HR–8). Since emergency emergency preparedness policies and program at a cost of $1,132. Thus, for all preparedness is a critical aspect of job- procedures to individuals providing 12,335 HHAs to comply will require an related safety, we expect that TJC- services under arrangement and estimated 197,360 burden hours (16 accredited HHAs will ensure that their volunteers, consistent with their burden hours for each HHA × 12,335 orientations and ongoing staff training expected roles. Hence, we will analyze HHAs) at a cost of $13,963,220 ($1,132 will include the facility’s emergency the burden of these requirements for all estimated cost for each HHA × 12,335 preparedness policies and procedures. 12,335 HHAs. HHAs).

TABLE 69—TOTAL COST ESTIMATE FOR A HHA TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 2 $194 Director of Nursing ...... 97 2 194 Director of Rehabilitation ...... 88 2 176 Office Manager ...... 52 2 104 Director of Training ...... 58 8 464

Total ...... 16 1,132

We also proposed that HHAs should event. Each HHA will also be required what type of drill HHAs must conduct review and update their emergency to analyze its responses to and maintain or require a tabletop exercise annually. preparedness training programs at least documentation of all drills, tabletop Thus, TJC accreditation standards will annually. The current CoPs require exercises, and emergency events, and not ensure that TJC-accredited HHAs HHAs to establish and annually review revise its emergency plan as needed. For will be in compliance with our the agency’s policies governing scope of the purposes of determining the burden requirements. Therefore, we will services offered, admission and for these requirements, we expect that include the 4,330 TJC-accredited HHAs discharge policies, medical supervision all HHAs will have to comply with all with the 8,005 non TJC-accredited and plans of care, emergency care of the requirements. The burden HHAs in our analysis of the burden for clinical records, and program associated with complying with this these requirements. evaluation. We believe that HHAs requirement will be the time and effort Based on our experience with HHAs, already review their training and testing necessary to develop the scenarios for we expect that the same individuals programs periodically. Thus, we believe the testing exercises and the required who are responsible for developing the compliance with this requirement will documentation. All TJC-accredited HHA’s training and testing program will constitute a usual and customary HHAs are required to test their develop the scenarios for the testing business practice for HHAs and will not emergency management plan once a exercises and the accompanying be subject to the PRA in accordance year; the test cannot be a tabletop documentation. We expect that the with the implementing regulations of exercise (CAMHC, Standard EC.4.20, EP director of nursing will spend more time the PRA at 5 CFR 1320.3(b)(2). 1 and Note 1, p. EC–11). The TJC also on these activities than will the other Section 484.22(d)(2) will require each requires HHAs to critique the drills and individuals. We estimate that it will HHA to conduct exercises to test its modify their emergency management require 7 burden hours for each HHA to emergency plan. Each HHA will have to plans in response to those critiques comply with the requirements at an participate in a full-scale exercise and (CAMHC, Standard EC.4.20, EPs 15–17, estimated cost of $586. Thus, for all one additional exercise at least p. EC–11). Therefore, TJC-accredited 12,335 HHAs to comply with the annually. If an HHA experiences an HHAs already prepare scenarios for requirements in this section will require actual natural or man-made emergency drills, develop documentation to record an estimated 86,345 burden hours (7 that requires activation of the the events during drills, critique them, burden hours for each HHA × 12,335 emergency plan, it will be exempt from and modify their emergency HHAs) at a cost of $7,228,310 ($586 engaging in a full-scale exercise for 1 preparedness plans in response. estimated cost for each HHA × 12,335 year following the onset of the actual However, TJC standards do not describe HHAs).

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TABLE 70—TOTAL COST ESTIMATE FOR A HHA TO CONDUCT TESTING

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 1 $97 Director of Nursing ...... 97 3 291 Director of Rehabilitation ...... 88 1 88 Office Manager ...... 52 1 52 Director of Training ...... 58 1 58

Total ...... 7 586

TABLE 71—BURDEN HOURS AND COST ESTIMATES FOR ALL 12,335 HHAS TO COMPLY WITH THE ICRS CONTAINED IN § 484.22 CONDITION: EMERGENCY PREPAREDNESS

Total Hourly labor Total labor OMB Number of Number of Burden per annual cost of cost of Total cost Regulation section(s) Control No. respondents responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 484.22(a)(1) ...... 0938–New ...... 8,005 8,005 11 88,055 ** 7,676,795 7,676,795 § 484.22(a)(1)–(4) (TJC-accredited) ...... 0938–New ...... 4,330 4,330 10 43,300 ** 3,732,460 3,732,460 § 484.22(a)(1)–(4) (Non TJC-accredited) ... 0938–New ...... 8,005 8,005 15 120,075 ** 10,350,465 10,350,465 § 484.22(b) ...... 0938–New ...... 12,335 12,335 18 222,030 ** 19,538,640 19,538,640 § 484.22(c) ...... 0938–New ...... 12,335 12,335 10 123,350 ** 10,188,710 10,188,710 § 484.22(d)(1) ...... 0938–New ...... 12,335 12,335 16 197,360 ** 13,963,220 13,963,220 § 484.22(d)(2) ...... 0938–New ...... 12,335 12,335 8 86,345 ** 7,228,310 7,228,310

Total ...... 24,670 69,680 ...... 880,515 ...... 72,678,600 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 71.

M. ICRs Regarding Condition of that all CORFs have performed some purposes of determining the burden, we Participation: Emergency Preparedness type of risk assessment during the will assume that the therapist is a (§ 485.68) process of developing their disaster physical therapist. We expect that both Section 485.68(a) will require all policies and procedures. However, their the administrator and the therapist will Comprehensive Outpatient risk assessments may not meet our attend an initial meeting, review Rehabilitation Facilities (CORFs) to requirements. Therefore, we expect that relevant sections of the current develop and maintain an emergency all CORFs will need to review their assessment, develop comments and preparedness plan that must be existing risk assessments and perform recommendations for changes, attend a reviewed and updated at least annually. the tasks necessary to ensure that those follow-up meeting, perform a final We proposed that the plan meet the assessments meet our requirements. review, and approve the new risk requirements listed at § 485.68(a)(1) We have not designated any specific assessment. We expect that the through (5). process or format for CORFs to use in administrator will coordinate the Section 485.68(a)(1) will require a conducting their risk assessments meetings, review and critique the risk CORF to develop a documented, because we believe they need the assessment, coordinate comments, facility-based and community-based risk flexibility to determine how best to develop the new risk assessment, and assessment utilizing an all-hazards accomplish this task. However, we ensure that it was approved. approach. The CORFs will need to expect that CORFs will obtain input We estimate that complying with this identify the medical and non-medical from all of their major departments. requirement will require 8 burden hours emergency events they could Based on our experience with CORFs, at a cost of $722. There are currently experience. The current CoPs for CORFs we expect that conducting the risk 205 CORFs. Therefore, it will require an already require CORFs to have ‘‘written assessment will require the involvement estimated 1,640 burden hours (8 burden policies and procedures that specifically of the CORF’s administrator and a hours for each CORF × 205 CORFs) for define the handling of patients, therapist. The type of therapists at each all CORFs to comply at a cost of personnel, records, and the public CORF varies, depending upon the $148,010 ($722 estimated cost for each during disasters’’ (§ 485.64). We expect services offered by the facility. For the CORF × 205 CORFs).

TABLE 72—TOTAL COST ESTIMATE FOR A CORF TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 5 $485 Physical Therapist ...... 79 3 237

Total ...... 8 722

After conducting the risk assessment, and, if necessary, develop new sections complied with our requirements. The each CORF will need to review, revise, for its emergency plan so that it current CoPs for CORFs require them to

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have a written disaster plan (§ 485.64) review, revise, and develop new complete the risk assessment. We that must be developed and maintained sections for their plans to ensure that estimate that complying with this with the assistance of appropriate their plans complied with all of our requirement will require 11burden experts and address, among other requirements. hours at a cost of $1,013 for each CORF. things, procedures concerning the Based on our experience with CORFs, Therefore, it will require an estimated transfer of casualties and records, we expect that the administrator and 2,255 burden hours (11 burden hours for notification of outside emergency physical therapist who were involved in each CORF × 205 CORFs) for all CORFs personnel, and evacuation routes developing the risk assessment will be to complete an emergency preparedness (§ 485.64(a)). Thus, we expect that all involved in developing the emergency plan at a cost of $207,665 ($1,013 CORFs have some type of emergency preparedness plan. However, we expect estimated cost for each CORF × 205 preparedness plan. However, we also that it will require more time to CORFs). expect that all CORFs will need to complete the emergency plan than to

TABLE 73—TOTAL COST ESTIMATE FOR A CORF TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 8 $776 Physical Therapist ...... 79 3 237

Total ...... 11 1,013

The CORF also will be required to policies and procedures at least ensure they complied with all of our review and update its emergency annually. We will require that a CORF’s requirements. preparedness plan at least annually. We policies and procedures address, at a We expect that both the administrator believe that CORFs already review their minimum, the requirements listed at and the therapist will attend an initial plans periodically. Therefore, § 485.68(b)(1) through (4). meeting, review relevant policies and compliance with the requirement for an We expect that all CORFs have some procedures, make recommendations for annual review of the emergency emergency preparedness policies and changes, attend a follow-up meeting, preparedness plan will constitute a procedures. As discussed earlier, the perform a final review, and approve the usual and customary business practice current CoPs for CORFs already require policies and procedures. We expect that for CORFs and will not be subject to the CORFs to have ‘‘written policies and the administrator will coordinate the PRA in accordance with the procedures that specifically define the meetings, coordinate the comments, and implementing regulations of the PRA at handling of patients, personnel, records, ensure that they are approved. 5 CFR 1320.3(b)(2). and the public during disasters’’ (42 We estimate that it will take 9 burden Section 485.68(b) will require CORFs CFR 485.64). However, all CORFs will hours for each CORF to comply with to develop and implement emergency need to review their policies and this requirement at a cost of $819. preparedness policies and procedures procedures and compare them to their Therefore, it will take all 205 CORFs based on their emergency plans, risk risk assessments, emergency 1,845 burden hours (9 burden hours for assessments, and communication plans preparedness plans, and communication each CORF × 205 CORFs = 1,845 burden as set forth in § 485.68(a), (a)(1), and (c), plans. Most CORFs will need to revise hours) to comply with this requirement respectively. We will also require their existing policies and procedures or at a cost of $167,895 ($819 estimated CORFs to review and update these develop new policies and procedures to cost for each CORF × 205 CORFs).

TABLE 74—TOTAL COST ESTIMATE FOR A CORF TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 6 $582 Physical Therapist ...... 79 3 237

Total ...... 9 819

Section 485.68(b) also proposes that Section 485.68(c) will require CORFs standard practice in the healthcare CORFs review and update their to develop and maintain emergency industry to maintain contact emergency preparedness policies and preparedness communication plans that information for staff and outside sources procedures at least annually. We believe complied with both federal and state of assistance; alternate means of that CORFs already review their policies law and that will be reviewed and communication in case there is an and procedures periodically. Therefore, updated at least annually. We proposed interruption in phone service to the we believe that complying with this that a CORF’s communication plan facility; and a method for sharing requirement will constitute a usual and include the information listed in information and medical documentation customary business practice for CORFs § 485.68(c)(1) through (5). Current CoPs with other healthcare providers to and will not be subject to the PRA in require CORFs to have a written disaster ensure continuity of care for their accordance with the implementing plan that must include, among other patients. However, many CORFs may regulations of the PRA at 5 CFR things, ‘‘procedures for notifying not have formal, written emergency 1320.3(b)(2). community emergency personnel’’ preparedness communication plans. (§ 486.64(a)(2)). In addition, it is Therefore, we expect that all CORFs will

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need to review, update, and in some primarily require the involvement of the for each CORF to comply with this cases, develop new sections for their CORF’s administrator with the requirement at a cost of $722. Therefore, plans to ensure they complied with all assistance of a physical therapist to it will take 1,640 burden hours (8 of our requirements. review, revise, and, if needed, develop burden hours for each CORF × 205 Based on our experience with CORFs, new sections for the CORF’s emergency CORFs) for all CORFs to comply at a we anticipate that satisfying the preparedness communication plan. We cost of $148,010 ($722 estimated cost for requirements in this section will estimate that it will take 8 burden hours each CORF × 205 CORFs).

TABLE 75—TOTAL COST ESTIMATE FOR A CORF TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 5 $485 Physical Therapist ...... 79 3 237

Total ...... 8 722

We proposed that each CORF will will also have to ensure that its staff well as ongoing training for all staff. also have to review and update its could demonstrate knowledge of its However, under this final rule, all emergency preparedness emergency procedures. All new CORFs will need to compare their communication plan at least annually. personnel will have to be oriented and current training programs to their risk We believe that compliance with this assigned specific responsibilities assessments, emergency preparedness requirement will constitute a usual and regarding the CORF’s emergency plan plans, policies and procedures, and customary business practice for CORFs within two weeks of their first workday. communication plans. CORFs will then and will not be subject to the PRA in In addition, the training program will need to revise, and in some cases, accordance with the implementing have to include instruction in the develop new material for their training regulations of the PRA at 5 CFR location and use of alarm systems and programs. 1320.3(b)(2). signals and firefighting equipment. Section 485.68(d) will require CORFs The current CORF CoPs at § 485.64 We expect that these tasks will to develop and maintain an emergency require CORFs to ensure that all require the involvement of an preparedness training and testing personnel are knowledgeable, trained, administrator and a physical therapist. program that must be reviewed and and assigned specific responsibilities We expect that the administrator will updated at least annually. We proposed regarding the facility’s disaster review the CORF’s current training that each CORF will have to satisfy the procedures. Section 485.64(b)(1) program to identify necessary changes requirements listed at § 485.68(d)(1) and specifies that CORFs must also provide and additions to the program. We expect (2). ongoing training and drills for all that the physical therapist will work Section 485.68(d)(1) will require that personnel associated with the facility in with the administrator to develop the each CORF provide initial training in all aspects of disaster preparedness. In revised and updated training program. emergency preparedness policies and addition, § 485.64(b)(2) specifies that all We estimate it will require 8 burden procedures to all new and existing staff, new personnel must be oriented and hours for each CORF to develop an individuals providing services under assigned specific responsibilities emergency training program at a cost of arrangement, and volunteers, consistent regarding the facility’s disaster plan $722. Therefore, for all CORFs to with their expected roles, and maintain within 2 weeks of their first workday. comply will require an estimated 1,640 documentation of the training. In evaluating the requirement for burden hours (8 burden hours for each Thereafter, each CORF will have to § 485.68(d)(1), we expect that all CORFs CORF × 205 CORFs) at a cost of provide emergency preparedness have an emergency preparedness $148,010 ($722 estimated cost for each training at least annually. Each CORF training program for new employees, as CORF × 205 CORFs).

TABLE 76—TOTAL COST ESTIMATE FOR A CORF TO CONDUCT TRAINING

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 5 $485 Physical Therapist ...... 79 3 237

Total ...... 8 722

We also proposed that each CORF business practice for CORFs and will exercise at least annually. If a CORF review and update its emergency not be subject to the PRA in accordance experienced an actual natural or man- preparedness training program at least with the implementing regulations of made emergency that required annually. We believe that CORFs the PRA at 5 CFR 1320.3(b)(2). activation of its emergency plan, it will already review their training programs Section 485.68(d)(2) will require be exempt from engaging in a full-scale periodically. Thus, we believe CORFs to participate in a full-scale exercise for 1 year following the onset complying with the requirement for an exercise and a paper-based, tabletop of the actual event. CORFs will also be annual review of the emergency exercise at least annually. If a full-scale required to analyze their responses to preparedness training program will exercise was not available, the CORF and maintain documentation of all constitute a usual and customary will have to conduct a full-scale drills, tabletop exercises, and emergency

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events, and revise their emergency CORF must use scenarios for their drills require 6 burden hours at a cost of $546. plans, as needed. To comply with this and tabletop exercises. Therefore, for all 205 CORFs to comply requirement, a CORF will need to Based on our experience with CORFs, will require an estimated 1,230 burden develop scenarios for these drills and we expect that the same individuals hours (6 burden hours for each CORF × exercises. The current CoPs at who develop the emergency 205 CORFs) at a cost of $111,930 ($528 § 485.64(b)(1) require CORFs to provide preparedness training program will estimated cost for each CORF × 221 ongoing training and drills for all develop the scenarios for the drills and CORFs). exercises, as well as the accompanying personnel associated with the facility in Based on the previous analysis, for all all aspects of disaster preparedness.’’ documentation. We expect that the administrator will spend more time on 205 CORFs to comply with the ICRs However, the current CoPs do not these tasks than the physical therapist. contained in this final rule will require specify the type of drill, how often the We estimate that for each CORF to 10,250 total burden hours at a total cost CORF must conduct drills, or that a comply with the requirements will of $931,520.

TABLE 77—TOTAL COST ESTIMATE FOR A CORF TO CONDUCT TESTING

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 4 $388 Physical Therapist ...... 79 2 158

Total ...... 6 546

TABLE 78—BURDEN HOURS AND COST ESTIMATES FOR ALL 205 CORFS TO COMPLY WITH THE ICRS CONTAINED IN § 485.68 CONDITION: EMERGENCY PREPAREDNESS

Hourly labor Total labor OMB Burden per Total annual cost of cost of Total cost Regulation section(s) Control No. Respondents Responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 485.68(a)(1) ...... 0938—New .... 205 205 8 1,640 ** 148,010 148,010 § 485.68(a)(2)–(4) ...... 0938—New .... 205 205 11 2,255 ** 207,665 207,665 § 485.68(b) ...... 0938—New .... 205 205 9 1,845 ** 167,895 167,895 § 485.68(c) ...... 0938—New .... 205 205 8 1,640 ** 148,010 148,010 § 485.68(d)(1) ...... 0938—New .... 205 205 8 1,640 ** 148,010 148,010 § 485.68(d)(2) ...... 0938—New .... 205 205 6 1,230 ** 111,930 111,930

Totals ...... 205 1,230 ...... 10,250 ...... 931,520 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 78.

N. ICRs Regarding Condition of Many of the TJC and AOA/HFAP Accreditation Manual for Critical Participation: Emergency Preparedness accreditation standards for CAHs are Access Hospitals: The Official (§ 485.625) similar to the requirements in this final Handbook 2008 (CAMCAH). In the Section 485.625(a) will require critical rule. For purposes of determining the chapter entitled, ‘‘Management of the access hospitals (CAHs) to develop and burden, we have analyzed the burden Environment of Care’’ (EC), Standard maintain a comprehensive emergency for the 338 TJC-accredited and 31 AOA/ EC.4.11 requires CAHs to plan for preparedness program that utilizes an HFAP-accredited CAHs separately from managing the consequences of all-hazards approach and will have to be the non-accredited CAHs. DNV GL’s emergency events (CAMCAH, Standard reviewed and updated at least annually. accreditation standards do not meet the EC.4.11, CAMCAH Refreshed Care, Each CAH’s emergency plan will have requirements for emergency January 2008, pp. EC–10–EC–11). CAHs to include the elements listed at preparedness of this final rule and as a are required to perform a hazard § 485.625(a)(1) through (4). result, we have included the DNV GL- vulnerability analysis (HVA), which Section 485.625(a)(1) will require accredited CAHs with the non- requires each CAH to, among other each CAH to develop a documented, accredited CAHs in our burden analysis. things, ‘‘identify events that could affect facility-based and community-based risk Note that we obtained data on the demand for its services or its ability to assessment utilizing an all-hazards number of CAHs, both accredited and provide those services, the likelihood of approach. CAHs will need to review non-accredited, from the CMS CASPER those events occurring, and the their existing risk assessments and database, which is updated periodically consequences of those events’’ perform any tasks necessary to ensure by the individual states. Due to (Standard EC.4.11, EP 2, p. EC–10a). that it complied with our requirements. variations in the timeliness of the data The HVA ‘‘should identify potential As of June 2016, there are submissions, all numbers are hazards, threats, and adverse events, approximately 1,337 CAHs. CAHs with approximate, and the number of and assess their impact on the care, distinct part units were included in the accredited and non-accredited CAHs treatment, and services [the CAH] must hospital burden analysis. may not equal the total number of sustain during an emergency,’’ and the Approximately 445 CAHs are accredited CAHs. HVA ‘‘is designed to assist [CAHs] in either by TJC (338), DNV GL (76), or by For purposes of determining the gaining a realistic understanding of their the AOA/HFAP (31); the remainder are burden for TJC-accredited CAHs, we vulnerabilities, and to help focus their non-accredited CAHs. used TJC’s Comprehensive resources and planning efforts’’

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(CAMCAH, Emergency Management, standards do not require a documented expect that CAHs will include Introduction, p. EC–10). Thus, we facility-based and community-based risk representatives from or obtain input expect that TJC-accredited CAHs assessment, as we proposed. Therefore, from all of their major departments in already conduct a risk assessment that we will include the 31 AOA/HFAP- the process of developing their risk will comply with the requirements we accredited CAHs with non-accredited assessments. proposed. Thus, for the 338 TJC- CAHs in determining the burden for our Based on our experience with CAHs, accredited CAHs, the risk assessment risk assessment requirement. we expect that these activities will The CAH CoPs currently require requirement will constitute a usual and require the involvement of a CAH’s customary business practice and will CAHs to assure the safety of their administrator, medical director, director not be subject to the PRA in accordance patients in nonmedical emergencies of nursing, facilities director, and food with the implementing regulations of (§ 485.623) and to take appropriate services director. We expect that these the PRA at 5 CFR 1320.3(b)(2). measures that are consistent with the individuals will attend an initial For purposes of determining the particular conditions in the area in meeting, review relevant sections of the burden for AOA/HFAP-accredited which the CAH is located current risk assessment, provide CAHs, we used the AOA/HFAP’s (§ 485.623(c)(4)). To satisfy this comments, attend a follow-up meeting, Healthcare Facilities Accreditation requirement in the CoPs, we expect that perform a final review, and approve the Program: Accreditation Requirements CAHs have already conducted some new or updated risk assessment. We for Critical Access CAHs 2007 type of risk assessment. However, that expect the administrator will coordinate (ARCAH). In Chapter 11 entitled, requirement does not ensure that CAHs the meetings, perform an initial review ‘‘Physical Environment,’’ CAHs are have conducted a documented, facility- of the current risk assessment, required to have disaster plans, external based, and community-based risk coordinate comments, develop the new disaster plans that include triaging assessment that will satisfy our risk assessment, and ensure that the victims, and weapons of mass requirements. destruction response plans (ARCAH, We believe that under this final rule, necessary parties approved it. Standards 11.07.01, 11.07.02, and the 999 non TJC-accredited CAHs (1,337 We estimate that the risk assessment 11.07.05–6, pp. 11–38 through 11–41, CAHs¥338 TJC-accredited CAHs) will requirement for non TJC-accredited respectively). In addition, AOA/HFAP- need to review, revise, and, in some CAHs will require 15 burden hours to accredited CAHs must ‘‘coordinate with cases, develop new sections for their complete at a cost of $1,495. We federal, state, and local emergency current risk assessments to ensure estimate that for the 999 non TJC- preparedness and health authorities to compliance with all of our accredited CAHs to comply with the identify likely risks for their area . . . requirements. risk assessment requirement will require and to develop appropriate responses’’ We have not designated any specific 14,985 burden hours (15 burden hours (ARCAH, Standard 11.02.02, p. 11–5). process or format for CAHs to use in for each CAH × 999 non TJC-accredited Thus, we believe that to develop their conducting their risk assessments CAHs) at a cost of $1,493,505 ($1,495 plans, AOA/HFAP-accredited CAHs because we believe that CAHs need the estimated cost for each non TJC- already perform some type of risk flexibility to determine the best way to accredited CAH × 999 non TJC- assessment. However, the AOA/HFAP accomplish this task. However, we accredited CAHs).

TABLE 79—TOTAL COST ESTIMATE FOR A NON-TJC ACCREDITED CAH TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 5 $485 Medical Director ...... 181 2 362 Director of Nursing ...... 97 3 291 Facility Director ...... 83 3 249 Food Services Director ...... 54 2 108

Total ...... 15 1,495

After conducting the risk assessment, responsibilities, utilities, and patient with the implementing regulations of CAHs will have to develop and clinical and support activities the PRA at 5 CFR 1320.3(b)(2). maintain emergency preparedness plans (CAMCAH, Standards EC.4.12 through The AOA/HFAP-accredited CAHs that comply with § 485.625(a)(1) 4.18, pp. EC–10a–EC–10g). In addition, must work with federal, state, and local through (4). We will expect all CAHs to as discussed earlier, TJC-accredited emergency preparedness authorities to compare their emergency plans to their CAHs also are required to conduct an identify the likely risks for their location risk assessments and then revise and, if HVA (CAMCAH, Standard EC.4.11, EP and geographical area and develop necessary, develop new sections for 2, p. EC–10a). Therefore, we expect that appropriate responses to assure the their emergency plans to ensure that the 338 TJC-accredited CAHs already safety of their patients (ARCAH, they complied with our requirements. have emergency preparedness plans that Standard 11.02.02, p. 11–5). Among the TJC-accredited CAHs must develop will satisfy our requirements. If a CAH elements that AOA/HFAP-accredited and maintain an Emergency Operations needed to complete additional tasks to CAHs must specifically consider are the Plan (EOP) (CAMCAH Standard comply with the requirement, the special needs of their patient EC.4.12, p. EC–10a). The EOP must burden will be negligible. Thus, for the population, availability of medical and cover the management of six critical 338 TJC-accredited CAHs, this non-medical supplies, both internal and areas during emergencies: requirement will constitute a usual and external communications, and the Communications, resources and assets, customary business practice and will transfer of patients to home or other safety and security, staff roles and not be subject to the PRA in accordance healthcare settings (ARCAH, Standard

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11.02.02, p. 11–5). In addition, there are these 31 AOA/HFAP-accredited CAHs who were involved in conducting the requirements for disaster and disaster with the non-accredited CAHs. risk assessment will be involved in response plans (ARCAH, Standards The CAH CoPs require all CAHs to developing the emergency preparedness 11.07.01, 11.07.02, and 11.07.06, pp. ensure the safety of their patients during plan. We expect that these individuals 11–38 through 11–40). There also are non-medical emergencies (§ 485.623). will attend an initial meeting, review specific requirements for plans for They are also required to provide, relevant sections of the current responses to weapons of mass among other things, for evacuation of emergency preparedness plan(s), destruction, including chemical, patients, cooperation with disaster prepare and send their comments to the nuclear, and biological weapons; authorities, emergency power and administrator, attend a follow-up communicable diseases, and chemical lighting in their emergency rooms and meeting, perform a final review, and exposures (ARCAH, Standards 11.07.02 for flashlights and battery lamps in approve the new plan. We expect that and 11.07.05–11.07.06, pp. 11–39 other areas, an emergency water and the administrator will coordinate the through 11–41). However, the AOA/ fuel supply, and any other appropriate meetings, perform an initial review, HFAP accreditation requirements measures that are consistent with their coordinate comments, revise the plan, require only that CAHs assess their most particular location (§ 485.623). Thus, we and ensure that the necessary parties likely risks (ARCAH, Standard 11– believe that all CAHs have developed approve the new plan. We estimate that 02.02, p. 11–5), and we are proposing some type of emergency preparedness complying with this requirement will that CAHs be required to conduct a risk plan. However, we also expect that the require 26 burden hours at a cost of assessment utilizing an all-hazards 999 non-accredited CAHs will have to $2,561. Therefore, we estimate that for approach. Thus, we expect that AOA/ review their current plans and compare all 999 non TJC-accredited CAHs to HFAP-accredited CAHs will have to them to their risk assessments and comply with this requirement will compare their risk assessments they revise and, in some cases, develop new require 25,974 burden hours (26 burden conducted in accordance with sections for their current plans to ensure hours for each non TJC-accredited CAH § 485.625(a)(1) to their current plans that their plans will satisfy our × 999 non TJC-accredited CAHs) at a and then revise, and in some cases requirements. cost of $2,558,439 ($2,561 estimated develop new sections for, their plans. Based on our experience with CAHs, cost for each non TJC-accredited CAH × Therefore, we will assess the burden for we expect that the same individuals 999 non TJC-accredited CAHs).

TABLE 80—TOTAL COST ESTIMATE FOR A NON-TJC ACCREDITED CAH TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 8 $776 Medical Director ...... 181 3 543 Director of Nursing ...... 97 6 582 Facility Director ...... 83 6 498 Food Services Director ...... 54 3 162

Total ...... 26 2,561.00

Under this final rule, CAHs also will policies and procedures will have to elements we proposed have a be required to review and update their address, at a minimum, the corresponding requirement in the CAH emergency preparedness plans at least requirements listed at § 485.625(b)(1) TJC accreditation standards. annually. The CAH CoPs already require through (8). We proposed at § 485.625(b)(1) that CAHs to perform a periodic evaluation We expect that all CAHs will review CAHs have policies and procedures that of their total program at least once a their policies and procedures and address the provision of subsistence year (§ 485.641(a)(1)). Hence, all CAHs compare them to their risk assessments, needs for staff and patients, whether should already have an individual or emergency preparedness plans, and they evacuate or shelter in place. TJC- team that is responsible that is for the emergency communication plans. The accredited CAHs must make plans for periodic review of their total program. CAHs will need to revise, and, in some obtaining and replenishing medical and Therefore, we believe that this cases, develop new policies and requirement will constitute a usual and procedures to incorporate all of the non-medical supplies, including food, customary business practice for CAHs provisions previously noted and address water, and fuel for generators and and will not be subject to the PRA in all of our requirements. transportation vehicles (CAMCAH, accordance with the implementing The CAMCAH chapter entitled, Standard EC.4.14, EPs 1–4, p. EC–10d). regulations of the PRA 5 CFR ‘‘Leadership’’ (LD), requires TJC- In addition, they must identify 1320.3(b)(2). accredited CAH leaders to ‘‘develop alternative means of providing Under § 485.625(b), we will require policies and procedures that guide and electricity, water, fuel, and other CAHs to develop and maintain support patient care, treatment, and essential utility needs in cases where emergency preparedness policies and services’’ (CAMCAH, Standard LC.3.90, their usual supply is disrupted or procedures based on their emergency EP 1, CAMCAH Refreshed Core, January compromised (CAMCAH, Standard plans, risk assessments, and 2008, p. LD–11). Thus, we expect that EC.4.17, EPs 1–5, p. EC–10f). We expect communication plans as set forth in TJC-accredited CAHs already have some that TJC-accredited CAHs that comply § 485.625(a), (a)(1), and (c), respectively. policies and procedures for the with these requirements will be in We will also require CAHs to review activities and processes required for compliance with our requirement and update these policies and accreditation, including their EOP. As concerning subsistence needs at procedures at least annually. These discussed later, many of the required § 485.625(b)(1).

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We are proposing at § 485.625(b)(2) In addition, TJC-accredited CAHs must 11–2). They also must have ‘‘written that CAHs have policies and procedures have plans for transporting patients and procedures for possible situations to be for a system to track the location of on- their clinical information, including followed by each department and duty staff and sheltered patients in the transferring information to ACSs service within the CAH and for each CAH’s care during an emergency. TJC- (CAMCAH Standard EC.4.14, EP 10 and building used for patient treatment or accredited CAHs must plan for 11, p. EC–10d and Standard EC.4.18, EP housing’’ (ARCAH, Standard 11.07.01 communicating with their staff, as well 6, pp. EC–10g, respectively). Therefore, Disaster Plans, Explanation, p. 11–38). as patients and their families, at the we expect that TJC-accredited CAHs AOA/HFAP-accredited CAHs also are beginning of and during an emergency will be substantially in compliance with required to have a safety team or (CAMCAH, Standard EC.4.13, EPs 1, 2, § 485.625(b)(5). committee that is responsible for all and 5, p. EC–10c). We expect that TJC- Section 485.625(b)(6) will require issues related to safety within the CAH accredited CAHs that comply with these CAHs to have policies and procedures (ARCAH, Standard 11.02.03, p. 11–7). requirements will be in compliance that addressed the use of volunteers in The individuals or team will be with our requirement. an emergency or other emergency responsible for all policies and Section 485.625(b)(3) will require staffing strategies. TJC-accredited CAHs procedures related to safety in the CAH CAHs to have a plan for the safe must define staff roles and (ARCAH, Standard 11.02.03, evacuation from the CAH. TJC- responsibilities in their EOP and ensure Explanation, p. 11–7). We expect that accredited CAHs are required to make that they train their staff for their these performance standards and plans to evacuate patients as part of assigned roles (CAMCAH, Standard procedures are similar to some of our managing their clinical activities EC.4.16, EPs 1 and 2, p. EC–10e). Also, requirements for policies and (CAMCAH, Standard EC.4.18, EP 1, p. the rationale for Standard EC.4.15 procedures. EC–10g). They also must plan for the indicates that the CAH ‘‘determines the In regard to § 485.625(b)(1), AOA/ evacuation and transport of patients, type of access and movement to be HFAP-accredited CAHs are required to their information, medications, allowed by . . . emergency volunteers consider ‘‘pharmaceuticals, food, other supplies, and equipment to alternative . . . when emergency measures are supplies and equipment that may be care sites (ACSs) when the CAH cannot initiated’’ (CAMCAH, Standard EC.4.15, needed during emergency/disaster provide care, treatment, and services in Rationale, p. EC–10d). In addition, in situations’’ and ‘‘provisions if gas, its facility (CAMCAH, Standard EC.4.14, the chapter entitled ‘‘Medical Staff’’ water, electricity supply is shut off to EPs 9–11, p. EC–10d). We expect that (MS), CAHs ‘‘may grant disaster the community’’ when they are TJC-accredited CAHs that comply with privileges to volunteers that are eligible developing their emergency plans these requirements will be in to be licensed independent (ARCAH, Standard 11.02.02 Building compliance with our requirement. practitioners’’ (CAMCAH, Standard Safety, Elements 5 and 11, pp. 11–5 and We proposed at § 485.625(b)(4) that MS.4.110, CAMCAH Refreshed Care, 11–6, respectively). In addition, CAHs CAHs have policies and procedures for January 2008, p. MS–20). Finally, in the are required ‘‘to provide emergency gas a means to shelter in place for patients, chapter entitled ‘‘Management of and water as needed to provide care to staff, and volunteers who remain in the Human Resources’’ (HR), CAHs ‘‘may inpatients and other persons who may facility. The rationale for CAMCAH assign disaster responsibilities to come to the CAH in need of care’’ Standard EC.4.18 states, ‘‘[a] volunteer practitioners’’ (CAMCAH, (ARCAH, Standard 11.03.22 Emergency catastrophic emergency may result in Standard HR.1.25, CAMCAH Refreshed Gas and Water, p. 11–22 through 11– the decision to keep all patients on the Core, January 2008, p. HR–6). Although 23). However, these standards do not premises in the interest of safety’’ the TJC accreditation requirements specifically address all of the (CAMCAH, Standard EC.4.18, p. EC– address some of our requirements, we requirements in this section. 10f). Therefore, we expect that TJC- do not believe TJC-accredited CAHs will In regard to § 485.625(b)(2), AOA/ accredited CAHs will be substantially in be in compliance with all requirements HFAP-accredited CAHs are required to compliance with our requirement. in § 485.625(b)(6). consider how they will communicate Section 485.625(b)(5) will require Based upon the previous discussion, with their staff within the CAH when CAHs to have policies and procedures we expect that the activities required for developing their emergency plans that address a system of medical compliance by TJC-accredited CAHs (ARCAH, Standard 11.02.02 Building documentation that preserves patient with § 485.625(b)(1) through (5) Safety, Element 7, p. 11–6). They also information, protects the confidentiality constitutes usual and customary are required to have a ‘‘call tree’’ in their of patient information, and ensures that business practices for PRAs and will not external disaster plan that must be records are secure and readily available. be subject to the PRA in accordance updated at least annually (ARCAH, The CAMCAH chapter entitled with the implementing regulations of Standard 11.07.04 Staff Call Tree, p. 11– ‘‘Management of Information’’ (IM), the PRA at 5 CFR 1320.3(b)(2). 40). However, these requirements do not requires TJC-accredited CAHs to have However, we do not believe TJC- sufficiently cover the requirements to storage and retrieval systems for their accredited CAHs will be substantially in track the location of staff and patients clinical/service and CAH-specific compliance with § 485.625(b)(6) through during and after an emergency. information (CAMCAH, Standard (8). We will discuss the burden for TJC- In regard to § 485.625(b)(3), which IM.3.10, EP 5, CAMCAH Refreshed accredited CAHs to comply with these requires policies and procedures Core, January 2008, p. IM–11), as well requirements later in this section. regarding the safe evacuation from the as to ensure the continuity of their The AOA/HFAP accreditation facility, AOA/HFAP-accredited CAHs critical information for patient care, standards also contain requirements for are required to consider the ‘‘transfer or treatment, and services (CAMCAH, policies and procedures related to safety discharge of patients to home, other Standard IM.2.30, CAMCAH Refreshed and disaster preparedness. The AOA/ healthcare settings, or other CAHs’’ and Core, January 2008, p. IM–9). They also HFAP-accredited CAHs are required to the ‘‘transfer of patients with CAH must ensure the privacy and maintain plans and performance equipment to another CAH or healthcare confidentiality of patient information standards for disaster preparedness setting’’ (ARCAH, Standard 11.02.02 (CAMCAH, Standard IM.2.10, CAMCAH (ARCAH, Standard 11.00.02 Required Building Safety, Elements 12 and 13, p. Refreshed Core, January 2008, p. IM–7). Plans and Performance Standards, p. 11–6). AOA/HFAP-accredited CAHs

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also are required to consider in their developing their emergency plan emergency policies and procedures. emergency plans how to maintain (ARCAH, Standard 11.02.02, Element 5, Based on our experience working with communication with external entities p. 11–5). However, these requirements CAHs, we expect that accomplishing should their telephones and computers do not specifically mention volunteers these activities will require the either cease to operate or become and CAHs are required only to consider involvement of an administrator, the overloaded (ARCAH, Standard 11.02.02, these elements in developing their medical director, director of nursing, Element 6, p. 11–6). AOA/HFAP- plans. facilities director, and food services accredited CAHs must also ‘‘develop Therefore, we believe that AOA/ director. We expect that the and implement a comprehensive plan to HFAP-accredited CAHs have likely administrator will review the policies ensure that the safety and well-being of already incorporated many of the and procedures and make patients are assured during emergency elements necessary to satisfy the recommendations for necessary changes situations’’ (ARCAH, Standard 11.02.02 requirements in § 485.625(b); however, or additional policies or procedures. Building Safety, pp. 11–4 through 11–7). they will need to thoroughly review The CAH administrator will brief other However, we do not believe these their current policies and procedures staff and assign staff to make necessary requirements are detailed enough to and perform whatever tasks are revisions or draft new policies and ensure that AOA/HFAP-accredited necessary to ensure that they complied procedures and disseminate them to the CAHs are compliant with our with all of our requirements for appropriate parties. We estimate that requirements. emergency policies and procedures. complying with this requirement will In regard to § 485.625(b)(4), AOA/ Because we expect that AOA/HFAP- require 10 burden hours for each TJC HFAP-accredited CAHs are required to accredited CAHs already comply with and AOA/HFAP-accredited CAH at a consider the special needs of their many of our requirements, we will cost of $983. For all 369 TJC and AOA/ patient population and the security of include the AOA/HFAP-accredited HFAP-accredited CAHs to comply with those patients and others that come to CAHs with the TJC-accredited CAHs in these requirements will require an them for care when they develop their determining the burden. estimated 3,690 burden hours (10 emergency plans (ARCAH, Standard The burden for the 31 AOA/HFAP- burden hours for each TJC or AOA/ 11.02.02 Building Safety, Elements 2 accredited CAHs and the 338 TJC- HFAP-accredited CAH × 369 TJC and and 3, p. 11–5). In addition, as accredited CAHs to comply with all of AOA/HFAP-accredited CAHs) at a cost described earlier, they also must the requirements in § 485.625(b) will be of $362,727 ($983 estimated cost for consider the food, pharmaceuticals, and the resources required to develop each TJC or AOA/HFAP-accredited CAH other supplies and equipment they may written policies and procedures that × 369 TJC and AOA/HFAP-accredited need during an emergency in comply with all of our requirements for CAHs).

TABLE 81—TOTAL COST ESTIMATE FOR AN ACCREDITED CAH TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 4 $388 Medical Director ...... 181 1 181 Director of Nursing ...... 97 2 194 Facility Director ...... 83 2 166 Food Services Director ...... 54 1 54

Total ...... 10 983.00

We expect that the 892 non-accredited or arrangements with one or more the non-accredited CAHs will require CAHs already have developed some providers or suppliers, as appropriate, more time to accomplish these emergency preparedness policies and to provide services to their patients activities. We estimate that a non- procedures. The current CAH CoPs (§ 485.635(c)). accredited CAH’s compliance will require CAHs to develop, maintain, and The burden associated with the require 14 burden hours at a cost of review policies to ensure quality care development of emergency policies and $1,357. For all 892 unaccredited CAHs and a safe environment for their patients procedures will be the resources needed to comply with this requirement will (§§ 485.627(a), 485.635(a), and to review, revise, and if needed, develop require an estimated 12,488 burden emergency preparedness policies and 485.641(a)(1)(iii)). In addition, certain hours (14 burden hours for each non- procedures that include our activities associated with our accredited CAHs × 892 non-accredited requirements. We believe the requirements are addressed in the CAHs) at a cost of $1,210,444 ($1,357 individuals and tasks will be the same current CAH CoPs. For example, all estimated cost for each non-accredited as described earlier for the TJC and × CAHs are required to have agreements AOA/HFAP-accredited CAHs. However, CAH 892 non-accredited CAHs).

TABLE 82—TOTAL COST ESTIMATE FOR A NON-ACCREDITED CAH TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 6 $582 Medical Director ...... 181 1 181 Director of Nursing ...... 97 3 291 Facility Director ...... 83 3 249 Food Services Director ...... 54 1 54

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TABLE 82—TOTAL COST ESTIMATE FOR A NON-ACCREDITED CAH TO DEVELOP POLICIES AND PROCEDURES—Continued

Position Hourly wage Burden hours Cost estimate

Total ...... 14 1,357

Section 485.625(b) will also require standard practice for healthcare include both internal and external CAHs to review and update their facilities to maintain contact communications (AOA/HFAP Standard emergency preparedness policies and information for both staff and outside 11.02.02, Elements 6, 7, and 10). Based procedures at least annually. As sources of assistance; alternate means of on these standards, we do not believe discussed earlier, TJC and AOA/HFAP- communications in case there is an they ensure compliance with accredited CAHs already periodically interruption in phone service to the § 485.625(c)(4) through (7). Thus, we review their policies and procedures. In facility; and a method for sharing will include these 31 AOA/HFAP- addition, the existing CAH CoPs require information and medical documentation accredited CAHs in the burden of this periodic reviews of the CAH’s with other healthcare providers to final rule. healthcare policies (§§ 485.627(a), ensure continuity of care for their The burden associated with 485.635(a), and 485.641(a)(1)(iii)). Thus, patients. Thus, we believe that most, if complying with this requirement will be we believe compliance with this not all, CAHs are already in compliance the resources required to develop a requirement will constitute a usual and with § 485.625(c)(1) through (3). communication plan that complied with customary business practice for all However, all CAHs will need to the requirements of this section. Based CAHs and will not be subject to the PRA review and, if needed, revise and update on our experience with CAHs, we in accordance with the implementing their plans to ensure compliance with expect that accomplishing these regulations of the PRA at 5 CFR § 485.625(c)(4) through (7). The TJC- activities will require the involvement 1320.3(b)(2). accredited CAHs are required to of an administrator, director of nursing, Section 485.625(c) will require CAHs establish strategies or plans for and the facilities director. We expect to develop and maintain emergency emergency communications (CAMCAH, that the administrator will review the preparedness communication plans that Standard 4.13, p. EC–10b–10c). These communication plan and make complied with both federal and state plans must cover both internal and recommendations for necessary changes law. We proposed that CAHs review and external communications and include or additions. The director of nursing update these plans at least annually. We back-up technologies and and the facilities director will meet with proposed that these communication communication systems (CAMCAH, the administrator to discuss and revise plans include the information listed at Standard 4.13, and EPs 1–14, p. EC– or draft new sections for the CAH’s § 485.625(c)(1) through (7). 10b–EC–10c). However, we do not existing emergency communication We expect that all CAHs will review believe that these standards will ensure plan. We estimate that complying with their emergency preparedness compliance with § 485.625(c)(4) through this requirement will require 9 burden communication plans and compare (7). Thus, we will include the 338 TJC- hours for each CAH at a cost of $831. them to their risk assessments and accredited CAHs in the burden of this We estimate that for all 1,337 CAHs to emergency plans. We also expect that final rule. comply with the requirements for an CAHs will revise and, if necessary, The AOA/HFAP-accredited CAHs emergency preparedness develop new sections that will comply must develop and implement communication plan will require 12,033 with our requirements. Based on our communication plans to ensure the burden hours (9 burden hours for each experience with CAHs, they have some safety of their patients during CAH × 1,337 CAHs) at a cost of type of emergency preparedness emergencies (AOA/HFAP Standard $1,111,047 ($831 estimated cost for each communication plan. Furthermore, it is 11.02.02). These plans must specifically CAH × 1,337 CAHs).

TABLE 83—TOTAL COST ESTIMATE FOR A CAH TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 3 $291 Director of Nursing ...... 97 3 291 Facility Director ...... 83 3 249

Total ...... 9 831

Section 485.625(c) also will require with the implementing regulations of Regarding § 485.625(d)(1), CAHs will CAHs to review and update their the PRA at 5 CFR 1320.3(b)(2). have to provide initial training in emergency preparedness Section 485.625(d) will require CAHs emergency preparedness policies and communication plans at least annually. to develop and maintain emergency procedures, including prompt reporting and extinguishing fires, protection, and All CAHs are required to evaluate their preparedness training and testing where necessary, evacuation of patients, entire program at least annually programs. We will also require CAHs to personnel, and guests, fire prevention, (§ 485.641(a)). Therefore, we believe review and update their training and compliance with this requirement will and cooperation with firefighting and testing programs at least annually. We disaster authorities, to all new and constitute a usual and customary proposed that a CAH comply with the business practice for CAHs and will not existing staff, individuals providing requirements listed at § 485.625(d)(1) services under arrangement, and be subject to the PRA in accordance and (2). volunteers, consistent with their

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expected roles, and maintain (CAMCAH, Standards HR.2.10 and 2.30, They also will need to revise, update, documentation of the training. pp. HR–8 and HR—9, respectively). On- or, in some cases, develop new Thereafter, the CAH will have to going training must also be documented materials for the initial and ongoing provide emergency preparedness (CAMCAH, Standard HR.2.30, EP 8, p. training. training at least annually. HR–10). The AOA/HFAP-accredited Based on our experience with CAHs, We expect that all CAHs will review CAHs are required to provide an we expect that complying with our their current training programs and education program for their staff and requirement will require the compare them to their risk assessments physicians for the CAH’s emergency involvement of an administrator, the and emergency preparedness plans, response preparedness (AOA/HFAP director of nursing, and the facilities emergency policies and procedures, and Standard 11.07.01). Each CAH also must emergency communication plans. The provide an education program director. We expect that the director of CAHs will need to revise and, if specifically for the CAH’s response plan nursing will perform the initial review necessary, develop new sections or for weapons of mass destruction (AOA of the training program, brief the materials to ensure their training and Standard 11.07.07). administrator and the director of testing programs complied with our Thus, we expect that all CAHs facilities, and revise or develop new requirements. provide some emergency preparedness sections for the training program, based Current CoPs require CAHs to train training for their staff. However, neither on the group’s decisions. We estimate their staffs on how to handle the current CoPs nor the TJC and AOA/ that each CAH will require 14 burden emergencies (§ 485.623(c)(1)). However, HFAP accreditation standards ensure hours to develop an emergency this training primarily addresses compliance with all our requirements. preparedness training program at a cost internal emergencies, such as a fire All CAHs will need to review their risk of $1,316. Therefore, for all 1,337 CAHs inside the facility. In addition, both TJC assessments, emergency preparedness to comply with this requirement will and AOA/HFAP require CAHs to plans, policies and procedures, and require an estimated 18,718 burden provide their staff with training. TJC- communication plans and then revise hours (14 burden hours for each CAH × accredited CAHs are required to provide or, in some cases, develop new sections 1,337 CAHs) at a cost of $1,759,492 their staff with both an initial for their training programs to ensure ($1,316 estimated cost for each CAH × orientation and on-going training compliance with our requirements. 1,337 CAHs).

TABLE 84—TOTAL COST ESTIMATE FOR A CAH TO CONDUCT TRAINING

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 2 $194 Director of Nursing ...... 97 9 873 Facility Director ...... 83 3 249

Total ...... 14 1,316

Section 485.625(d)(1) also will require Section 485.625(d)(2) will require The TJC-accredited CAHs are required CAHs to review and update their CAHs to participate in a full-scale to test their EOP twice a year, either as emergency preparedness training exercise and a paper-based, tabletop a planned exercise or in response to an programs at least annually. Existing exercise at least annually. If a full-scale emergency (CAMCAH, Standard regulations require all CAHs to evaluate exercise was not available, the CAH will EC.4.20, EP 1, p. EC–12). These tests their entire program at least annually have to conduct a full-scale exercise at must be monitored, documented, and (§ 485.641(a)). Therefore, we believe least annually. CAHs also will be analyzed (CAMCAH, Standard EC.4.20, compliance with this requirement will required to analyze the CAH’s response EPs 8–19, pp. EC–12–EC–13). Thus, we constitute a usual and customary to and maintain documentation of all believe that TJC-accredited CAHs business practice for CAHs and will not drills, tabletop exercises, and emergency already develop scenarios for these be subject to the PRA in accordance events, and revise the CAH’s emergency tests. We also expect that they also have with the implementing regulations of plan, as needed. If a CAH experienced developed the documentation necessary to record and analyze their tests and the PRA at 5 CFR 1320.3(b)(2). an actual natural or man-made responses to actual emergency events. emergency that required activation of The CAHs also will be required to Therefore, we believe compliance with the emergency plan, it will be exempt maintain documentation of their this requirement will constitute a usual training. Based on our experience with from the requirement for a full-scale and customary business practice for CAHs, it is standard practice for them to exercise for 1 year following the onset TJC-accredited CAHs and will not be document the training they provide to of the emergency (§ 485.625(d)(2)(ii)). subject to the PRA in accordance with staff and other individuals. If a CAH Thus, to meet these requirements, CAHs the implementing regulations of the needed to make any changes to their will need to develop scenarios for each PRA at 5 CFR 1320.3(b)(2). drill and exercise and develop the normal business practices to comply The AOA/HFAP-accredited CAHs are required documentation. with this requirement, the burden will required to conduct two disaster drills be negligible. Thus, we believe If a CAH participated in a full-scale annually (AOA/HFAP Standard compliance with this requirement will exercise, it will likely not need to 11.07.03). In addition, AOA/HFAP- constitute a usual and customary develop the scenario for that drill. accredited CAHs are required to business practice for CAHs and will not However, for the purpose of participate in weapons of mass be subject to the PRA in accordance determining the burden, we will assume destruction drills, as appropriate (AOA/ with the implementing regulations of that CAHs need to develop scenarios for HFAP Standard 11.07.09). We expect the PRA at 5 CFR 1320.3(b)(2). both the testing exercises annually. that since AOA/HFAP-accredited CAHs

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already conduct disaster drills, they also preparedness plans. However, this does accompanying documentation. We develop scenarios for the drills. In not ensure that most CAHs already expect that the director of nursing will addition, it is standard practice in the perform the activities needed to comply spend more time than will the other healthcare industry to document and with our requirements. Thus, we will individuals developing the scenarios analyze tests that a facility conducts. analyze the burden for these and the accompanying documentation. Thus, we believe compliance with this requirements for the 892 non-accredited We estimate that it will require 8 burden requirement will constitute a usual and CAHs. hours for the 892 non-accredited CAHs customary business practice for AOA/ The 892 non-accredited CAHs will be to comply with these requirements at a required to develop scenarios for testing HFAP-accredited CAHs and will not be cost of $762. Therefore, for all 892 non- subject to the PRA in accordance with exercises and the documentation accredited CAHs to comply with these the implementing regulations of the necessary to record and later analyze the requirements will require an estimated PRA at 5 CFR 1320.3(b)(2). events that occurred during these tests 7,136 burden hours (8 burden hours for Based on our experience with CAHs, and actual emergency events. Based on × we expect that the 892 non-accredited our experience with CAHs, we believe each non-accredited CAH 892 non- CAHs already have some type of that the same individuals who accredited CAHs) at a cost of $679,704 emergency preparedness training developed the emergency preparedness ($762 estimated cost for each non- × program and conduct some type of drills training program will develop the accredited CAH 892 non-accredited or exercises to test their emergency scenarios for the tests and the CAHs).

TABLE 85—TOTAL COST ESTIMATE FOR A NON-ACCREDITED CAH TO CONDUCT TESTING

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 1 $97 Director of Nursing ...... 97 6 582 Facility Director ...... 83 1 83

Total ...... 8 762

TABLE 86—BURDEN HOURS AND COST ESTIMATES FOR ALL 1,337 CAHS TO COMPLY WITH THE ICRS CONTAINED IN § 485.625 CONDITION: EMERGENCY PREPAREDNESS

Total Hourly labor Total labor OMB Burden per annual cost of cost of Total cost Regulation section(s) Control No. Respondents Responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 485.625(a)(1) ...... 0938–New .... 999 999 15 14,985 ** 1,493,505 1,493,505 § 485.625(a)(2)–(4) ...... 0938–New .... 999 999 26 25,974 ** 2,558,439 2,558,439 § 485.625(b) (TJC and AOA/HFAP-Accredited) 0938–New .... 369 369 10 3,690 ** 362,727 362,727 § 485.625(b) (Non-accredited) ...... 0938–New .... 892 892 14 12,488 ** 1,210,444 1,210,444 § 485.625(c) ...... 0938–New .... 1,337 1,337 9 12,033 ** 1,111,047 1,111,047 § 485.625(d)(1) ...... 0938–New .... 1,337 1,337 14 18,718 ** 1,759,492 1,759,492 § 485.625(d)(2) ...... 0938–New .... 892 892 8 7,136 ** 679,704 679,704

Total ...... 3,597 6,825 ...... 95,024 ...... 9,175,358 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 86.

O. ICRs Regarding Condition of both at their facilities and in the flexibility to determine the best way to Participation: Emergency Preparedness surrounding area. accomplish this task. Providers of (§ 485.727) The current CoPs for Organizations physical therapy and speech therapy Section 485.727(a) will require require these providers to have ‘‘a services should include input from all clinics, rehabilitation agencies, and written plan in operation, with of their major departments in the public health agencies as providers of procedures to be followed in the event process of developing their risk outpatient physical therapy and speech- of fire, explosion, or other disaster’’ assessments. Based on our experience language pathology services (§ 485.727(a)). To comply with this CoP, with these providers, we expect that (organizations) to develop and maintain we expect that all of these providers conducting the risk assessment will emergency preparedness plans and have already performed some type of require the involvement of the review and update the plan at least risk assessment during the process of organization’s administrator and a annually. We are proposing that the developing their disaster plans and therapist. The types of therapists at each plan comply with the requirements policies and procedures. However, these Organization vary depending upon the listed at § 485.727(a)(1) through (6). providers will need to review their services offered by the facility. For the Section 485.727(a)(1) will require current risk assessments and make any purposes of determining the PRA organizations to develop documented, revisions to ensure they complied with burden, we will assume that the facility-based and community-based risk our requirements. therapist is a physical therapist. We assessment utilizing an all-hazards We have not designated any specific expect that both the administrator and approach. Organizations will need to process or format for these providers to the therapist will attend an initial identify the medical and non-medical use in conducting their risk assessments meeting, review the current assessment, emergency events they could experience because we believe that they need the develop comments and

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recommendations for changes to the comments, develop the new risk burden hours at a cost of $901. We assessment, attend a follow-up meeting, assessment, and ensure that the estimate that it will require 19,215 perform a final review, and approve the necessary parties approve it. We also burden hours (9 burden hours for each new risk assessment. We expect that the expect that the administrator will spend organization × 2,135 organizations) for administrator will coordinate the more time reviewing and working on all organizations to comply with this meetings, review and critique the the risk assessment than the physical requirement at a cost of $1,710,135 current risk assessment initially, offer therapist. We estimate that complying ($901 estimated cost for each suggested revisions, coordinate with this requirement will require 9 organization × 2,135 organizations).

TABLE 87—TOTAL ESTIMATED COST FOR AN ORGANIZATION TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $94 6 $564 Physical Therapist ...... 79 3 237

Total ...... 9 801

After conducting the risk assessment, organizations have some type of developing the emergency preparedness each organization will need to develop emergency preparedness plan and that plan. However, we expect it will require and maintain an emergency these plans address many of our more time to complete the plan and that preparedness plan and review and requirements. However, all the administrator will be the most update it at least annually. Current CoPs organizations will need to review their heavily involved in reviewing and require these providers to have a written current plans and compare them to their developing the organization’s disaster plan with accompanying risk assessments. Each organization will emergency preparedness plan. We procedures for fires, explosions, and need to revise, update, and, in some estimate that for each organization to other disasters (§ 485.727(a)). The plan cases, develop new sections to complete comply will require 12 burden hours at a comprehensive emergency must include or address the transfer of a cost of $1,083. We estimate that it will preparedness plan that complied with casualties and records, the location and require 25,620 burden hours (12 burden our requirements. × use of alarm systems and signals, Based on our experience with these hours for each organization 2,135 methods of containing fire, notification organizations, we expect that the organizations) to complete the plan at a of appropriate persons, and evacuation administrator and physical therapist cost of $2,312,205 ($1,083 estimated × routes and procedures (§ 485.727(a)). who were involved in developing the cost for each organization 2,135 Thus, we expect that all of these risk assessment will be involved in organizations).

TABLE 88—TOTAL ESTIMATED COST FOR AN ORGANIZATION TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $94 9 $846 Physical Therapist ...... 79 3 237

Total ...... 12 1,083

Each organization will also be procedures at least annually. At a incorporate all of the necessary required to review and update its minimum, we will require that an elements of their emergency emergency preparedness plan at least organization’s policies and procedures preparedness program, and, if annually. We believe that these address the requirements listed at necessary, take the appropriate steps to organizations already review their plans § 485.727(b)(1) through (4). ensure that their policies and periodically. Thus, we believe We expect that all organizations have procedures are in compliance with our complying with this requirement will emergency preparedness policies and requirements. constitute a usual and customary procedures. As discussed earlier, the We expect that the administrator and business practice for organizations and current CoPs require organizations to the physical therapist will be primarily will not be subject to the PRA in have procedures within their written involved with reviewing and revising accordance with the implementing disaster plan to be followed for fires, the current policies and procedures and, regulations of the PRA at 5 CFR explosions, or other disasters if needed, developing new policies and 1320.3(b)(2). (§ 485.727(a)). In addition, we expect procedures. We estimate that it will Section 485.727(b) will require that those procedures already address require 10 burden hours for each organizations to develop and implement some of the specific elements required organization to comply at a cost of $895. emergency preparedness policies and in this section. For example, the current We estimate that for all organizations to procedures based on their risk requirements at § 485.727(a)(1) through comply will require 21,350 burden assessments, emergency plans, (4) are similar to our requirements at hours (10 burden hours for each communication plans as set forth in § 485.727(a)(1) through (5). However, all organization × 2,135 organizations) at a § 485.727(a)(1), (a), and (c), respectively. organizations will need to review their cost of $1,910,825 ($895 estimated cost It will also require organizations to policies and procedures, assess whether for each organization × 2,135 review and update these policies and their policies and procedures organizations).

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TABLE 89—TOTAL ESTIMATED COST FOR AN ORGANIZATION TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $94 7 $658 Physical Therapist ...... 79 3 237

Total ...... 10 895

We will require organizations to We expect that all organizations have preparedness communication plans or review and update their emergency some type of emergency preparedness their plans may not be fully compliant preparedness policies and procedures at communication plan. Current CoPs for with our requirements. Therefore, we least annually. We believe that these these organizations already require them expect that all organizations will need providers already review their to have a written disaster plan with to review, update, and, in some cases, emergency preparedness policies and procedures that must include, among develop new sections for their plans. other things, ‘‘notification of procedures periodically. Therefore, we Based on our experience with these believe compliance with this appropriate persons’’ (§ 485.727(a)(4)). Thus, we expect that each organization organizations, we anticipate that requirement will constitute a usual and satisfying the requirements in this customary business practice and will has the contact information they will need to comply with this requirement. section will primarily require the not be subject to the PRA in accordance involvement of the organization’s with the implementing regulations of In addition, it is standard practice for healthcare facilities to maintain contact administrator with the assistance of a the PRA at 5 CFR 1320.3(b)(2). information for both staff and outside physical therapist. We estimate that for Section 485.727(c) will require sources of assistance; alternate means of each organization to comply will require organizations to develop and maintain communications in case there is an 8 burden hours at a cost of $722. We emergency preparedness interruption in phone service to the estimate that for all 2,135 organizations communication plans that complied facility; and a method for sharing to comply will require 17,080 burden with both federal and state law and will information and medical documentation hours (8 burden hours for each be reviewed and updated at least with other healthcare providers to organizations × 2,135 organizations) at a annually. The communication plan will ensure continuity of care for their cost of $1,541,470 ($722 estimated cost have to include the information listed at patients. However, many organizations for each organization × 2,135 § 485.727(c)(1) through (5). may not have formal, written emergency organizations).

TABLE 90—TOTAL ESTIMATED COST FOR AN ORGANIZATION TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $94 6 $564 Physical Therapist ...... 79 2 158

Total ...... 8 722

We are proposing that organizations preparedness policies and procedures to preparedness plans, policies and must review and update their all new and existing staff, individuals procedures, and communication plans. emergency preparedness providing services under arrangement, Organizations will need to review, communication plans at least annually. and volunteers, consistent with their revise, and, in some cases, develop new We believe that these organizations expected roles, and maintain material for their training programs so already review their emergency documentation of the training. that they comply with our requirements. communication plans periodically. Thereafter, the CAH will have to We expect that complying with this Thus, we believe compliance with this provide emergency preparedness requirement will require the requirement will constitute a usual and training at least annually. involvement of an administrator and a customary business practice and will Current CoPs require organizations to physical therapist. We expect that the not be subject to the PRA in accordance ensure that ‘‘all employees are trained, administrator will primarily be involved with the implementing regulations of as part of their employment orientation, in reviewing the organization’s current the PRA at 5 CFR 1320.3(b)(2). in all aspects of preparedness for any training program and the current Section 485.727(d) will require disaster. The disaster program includes emergency preparedness program; organizations to develop and maintain orientation and ongoing training and determining what tasks will need to be emergency preparedness training and drills for all personnel in all procedures performed and what materials will need testing programs and review and update in case of a disaster (42 CFR 485.727(b)). to be developed to comply with our these programs at least annually. Thus, we expect that organizations requirements; and developing the Specifically, we are proposing that already have an emergency materials for the training program. We organizations comply with the preparedness training program for new expect that the physical therapist will requirements listed at § 485.727(d)(1) employees, as well as ongoing training work with the administrator to develop and (2). for all staff. However, organizations will the revised and updated training According to § 485.727(d)(1), need to review their current training program. We estimate that it will require organizations will have to provide programs and compare them to their 8 burden hours for each organization to initial training in emergency risk assessments and emergency develop a comprehensive emergency

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training program at a cost of $722. each organization × 2,135 organizations) for each organization × 2,135 Therefore, it will require an estimated to comply with this requirement at a organizations). 17,080 burden hours (8 burden hours for cost of $1,541,470 ($722 estimated cost

TABLE 91—TOTAL ESTIMATED COST FOR AN ORGANIZATION TO CONDUCT TRAINING

Position Hourly wage Burden hours Cost estimate

Administrator ...... $94 6 $564 Physical Therapist ...... 79 2 158

Total ...... 8 722

In § 485.727(d)(1), we also proposed and maintain documentation of all the with our requirements. Therefore, we requiring that an organization must testing exercises and emergency events, will analyze the burden from these review and update its emergency and revise their emergency plan, as requirements for all organizations. preparedness training program at least needed. To comply with this The 2,135 organizations will be annually. We believe that these requirement, an organization will need required to develop scenarios for testing providers already review their to develop scenarios for their drills and exercises and the necessary emergency preparedness training exercises. An organization also will programs periodically. Thus, we believe have to develop the documentation documentation. Based on our compliance with this requirement will necessary for recording and analyzing experience with organizations, we constitute a usual and customary their responses to the testing exercises expect that the same individuals who business practice and will not be subject and actual emergency events. develop the emergency preparedness to the PRA in accordance with the The current CoPs require training program will develop the implementing regulations of the PRA at organizations to have a written disaster scenarios for the drills and exercises 5 CFR 1320.3(b)(2). plan that is periodically rehearsed and and the accompanying documentation. Section 485.727(d)(2) will require have ongoing drills (§ 485.727(a) and We expect that the administrator will organizations to participate in a full- (b)). Thus, we expect that all 2,135 spend more time than the physical scale exercise at least annually. They organizations currently conduct some therapist developing the scenarios and will also be required to conduct one type of drill or exercise of their disaster the documentation. We estimate that for additional exercise of their choice at plan. However, the current each organization to comply will require least annually. If an organization organizations CoPs do not specify the 3 burden hours at a cost of $267. Based experienced an actual natural or man- type of drill, how they are to conduct on that estimate, it will require 6,405 made emergency that required the drills, or whether the drills should burden hours (3 burden hours for each activation of its emergency plan, it will be community-based. In addition, there organization x 2,135 organizations) at a be exempt from engaging in a drill for is no requirement for a paper-based, cost of $570,045 ($267 estimated cost for 1 year following the onset of the actual tabletop exercise. Thus, these each organization x 2,135 event. Organizations also will be requirements do not ensure that organizations). required to analyze their response to organizations will be in compliance

TABLE 92—TOTAL ESTIMATED COST FOR AN ORGANIZATION TO CONDUCT TESTING

Position Hourly wage Burden hours Cost estimate

Administrator ...... $90 2 $188 Physical Therapist ...... 76 1 79

Total ...... 3 267

TABLE 93—BURDEN HOURS AND COST ESTIMATES FOR ALL 2,135 ORGANIZATIONS TO COMPLY WITH THE ICRS CONTAINED IN § 485.727 CONDITION: EMERGENCY PREPAREDNESS

Hourly labor Total labor OMB Burden per Total annual cost of cost of Total cost Regulation section(s) Control No. Respondents Responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 485.727(a)(1) ...... 0938–New ...... 2,135 2,135 9 19,215 ** 1,710,135 1,710,135 § 485.727(a)(2)–(4) ...... 0938–New ...... 2,135 2,135 12 25,620 ** 2,312,205 2,312,205 § 485.727(b) ...... 0938–New ...... 2,135 2,135 10 21,350 ** 1,910,825 1,910,825 § 485.727(c) ...... 0938–New ...... 2,135 2,135 8 17,080 ** 1,541,470 1,541,470 § 485.727(d)(1) ...... 0938–New ...... 2,135 2,135 8 17,080 ** 1,541,470 1,541,470 § 485.727(d)(2) ...... 0938–New ...... 2,135 2,135 3 6,405 ** 570,045 570,045

Totals ...... 2,135 12,8100 ...... 106,750 ...... 9,586,150 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 93.

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P. ICRs Regarding Condition of practice for healthcare organizations to mental health counselor. We expect that Participation: Emergency Preparedness prepare for common emergencies, such most of these individuals will attend an (§ 485.920) as fires, interruptions in communication initial meeting, review relevant sections Section 485.920(a) will require and power, and storms. However, many of the current assessment, prepare and Community Mental Health Centers CMHCs may not have performed a risk forward their comments to the (CMHCs) to develop and maintain an assessment that complies with the administrator, attend a follow-up emergency preparedness plan that must requirements. Therefore, we expect that meeting, perform a final review, and be reviewed and updated at least most, if not all, CMHCs will have to approve the risk assessment. We expect annually. Specifically, we proposed that perform a thorough review of their that the administrator will coordinate the plan must meet the requirements current risk assessment and perform the the meetings, do an initial review of the listed at § 485.920(a)(1) through (4). tasks necessary to ensure that the current risk assessment, critique the risk We expect all CMHCs to identify the facility’s risk assessment complies with assessment, offer suggested revisions, likely medical and non-medical the requirements. coordinate comments, develop the new emergency events they could experience We have not designated any specific risk assessment, and assure that the within the facility and the community process or format for CMHCs to use in necessary parties approve the new risk in which it is located and determine the conducting their risk assessments assessment. It is likely that the CMHC likelihood of the facility experiencing because we believe CMHCs need administrator will spend more time an emergency due to the identified maximum flexibility in determining the reviewing and working on the risk hazards. We expect that in performing best way for their facilities to assessment than the other individuals. the risk assessment, a CMHC will need accomplish this task. However, we We estimate that complying with the to consider its physical location, the expect that in the process of developing requirement to conduct a risk geographical area in which it is located a risk assessment, healthcare assessment will require 10 burden hours and its patient population. organizations will include for a cost of $788. There are currently The burden associated with this representatives from or obtain input 198 CMHCs. Therefore, it will require requirement will be the time and effort from all major departments. Based on an estimated 1,980 burden hours (10 necessary to perform a thorough risk our experience with CMHCs, we expect burden hours for each CMHC x 198 assessment. We expect that most, if not that conducting the risk assessment will CMHCs) for all CMHCs to comply with all, CMHCs have already performed at require the involvement of the CMHC this requirement at a cost of $156,024 least some of the work needed for a risk administrator, a psychiatric registered ($788 estimated cost for each CMHC × assessment because it is standard nurse, and a clinical social worker or 198 CMHCs).

TABLE 94—TOTAL COST ESTIMATE FOR A CMHC TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $94 6 $564 Psychiatric Registered Nurse ...... 71 2 142 Social Worker ...... 41 2 82

Total ...... 10 788

After conducting the risk assessment, emergency events or address their involved in the risk assessment will be CMHCs will need to develop and patient population, the type of services involved in developing the emergency maintain an emergency preparedness they have the ability to provide in an preparedness plan. We also expect that plan that must be reviewed and updated emergency, or continuity of operation, developing the plan will require more at least annually. CMHCs will need to including delegations of authority and time to complete than the risk compare their current emergency plan, succession plans. We expect that assessment. We expect that the if they have one, to their risk CMHCs will have to review their current administrator and a psychiatric nurse assessment. They will then need to plan and compare it to their risk will spend more time reviewing and revise and, if necessary, develop new assessment, as well as to the other developing the CMHC’s emergency sections of their plan to ensure it requirements in § 485.920(a). We expect preparedness plan. We expect that the complies with the requirements. that most CMHCs will need to update clinical social worker or mental health It is standard practice for healthcare and revise their existing emergency plan organizations to make plans for common and, in some cases, develop new counselor will review the plan and disasters they may confront, such as sections to comply with our provide comments on it to the fires, interruptions in communication requirements. administrator. We estimate that it will and power, and storms. Thus, we expect The burden associated with this require 15 burden hours for a CMHC to that all CMHCs have some type of requirement will be due to the resources develop its emergency plan at a cost of emergency preparedness plan. However, needed to develop an emergency $1,113. Based on this estimate, it will their plan may not address all likely preparedness plan or to review, revise, require 2,970 burden hours (15 burden medical and non-medical emergency and develop new sections for an hours for each CMHC × 198 CMHCs) for events identified by the risk assessment. existing emergency plan. Based upon all CMHCs to complete their plans at a Furthermore, their plans may not our experience with CMHCs, we expect cost of $220,374 ($1,113 estimated cost include strategies for addressing likely that the same individuals who were for each CMHC × 198 CMHCs).

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TABLE 95—TOTAL COST ESTIMATE FOR A CMHC TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $94 6 $564 Psychiatric Registered Nurse ...... 71 6 426 Social Worker ...... 41 3 123

Total ...... 15 220,374

The CMHC will be required to review practice in the healthcare industry for and update the plan. We expect that the and update its emergency preparedness facilities to have professional staff administrator and registered nurse will plan at least annually. For the purpose persons who periodically review their spend more time than the social worker of determining the burden for this plans and procedures. However, the on the review of the plan and requirement, we expect that the CMHCs current CMHC CoPs do not include a documentation of the plan updates. We will review and update their plans requirement for an emergency estimate that for each CMHC to comply annually. preparedness plan and as such, there is will require 5 burden hours at a cost of We expect that all CMHCs have an no requirement for an annual review of $371. Based on that estimate, it will administrator that is responsible for the the plan. Therefore, we will analyze the require 990 burden hours (5 burden day-to-day operation of the CMHC. This burden from this requirement for all hours for each organization × 198 will include ensuring that all of the CMHCs. organizations) at a cost of $73,458 ($371 CMHC’s plans are up-to-date and Based on our experience with × comply with the relevant federal, state, CMHCs, we expect that the same estimated cost for each organization and local laws, regulations, and individuals who develop the emergency 198 organizations). ordinances. In addition, it is standard preparedness plan will annually review

TABLE 96—TOTAL ESTIMATED COST FOR A CMHC TO REVIEW AND UPDATE AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $94 2 $188 Registered Nurse ...... 71 2 142 Social Worker ...... 41 1 41

Total ...... 5 371.00

Section 485.920(b) will require preparedness policies and procedures to psychiatric registered nurse will be CMHCs to develop and maintain their emergency preparedness plan, involved with reviewing, revising and, emergency preparedness policies and communication plan, and their training if needed, developing any new policies procedures based on the emergency and testing program. They will need to and procedures. We estimate that for a plan, the communication plan, and the review, revise and, if necessary, develop CMHC to comply with this requirement risk assessment. We also proposed new policies and procedure to ensure will require 12 burden hours at a cost requiring CMHCs to review and update they comply with the requirements. The of $944. Therefore, for all 198 CMHCs these policies and procedures at least burden associated with reviewing, to comply with this requirement will annually. The CMHC’s policies and revising, and updating the CMHC’s require an estimated 2,376 burden hours procedures will be required to address, emergency policies and procedures will (12 burden hours for each CMHC × 198 at a minimum, the requirements listed be due to the resources needed to ensure CMHCs) at a cost of $186,912 ($944 at § 485.920(b)(1) through (7). × We expect that all CMHCs will they comply with the requirements. We estimated cost for each CMHC 198 compare their current emergency expect that the administrator and the CMHCs).

TABLE 97—TOTAL COST ESTIMATE FOR A CMHC TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $94 4 $376 Psychiatric Registered Nurse ...... 71 8 568

Total ...... 12 944

The CMHCs will be required to procedures annually. We expect that all local laws, regulations, and ordinances. review and update their emergency CMHCs have an administrator who is We also expect that the administrator is preparedness policies and procedures at responsible for the day-to-day operation responsible for periodically reviewing least annually. For the purpose of of the CMHC, which includes ensuring the emergency preparedness policies determining the burden for this that all of the CMHC’s policies and and procedures as part of his or her requirement, we expect that CMHCs procedures are up-to-date and comply responsibilities. We expect that will review their policies and with the relevant federal, state, and complying with the requirement for an

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annual review of the emergency CMHCs will need to perform any tasks in some cases, develop new sections for preparedness policies and procedures necessary to ensure that their their plans to ensure that those plans will constitute a usual and customary communication plans were documented include all of the elements we are business practice for CMHCs. As stated and in compliance with the requiring for CMHC communications in the implementing regulations of the requirements. plans. PRA at 5 CFR 1320.3(b)(2), the time, We expect that all CMHCs have some The burden associated with effort, and financial resources necessary type of emergency preparedness complying with this requirement will be to comply with a collection of communications plan. However, their due to the resources required to ensure information that will be incurred by emergency communications plan may that the CMHC’s emergency persons in the normal course of their activities are not subject to the PRA. not be thoroughly documented or communication plan complies with the Section 485.920(c) will require comply with all of the elements we are requirements. Based upon our CMHCs to develop and maintain an requiring. It is standard practice for experience with CMHCs, we expect the emergency preparedness healthcare organizations to maintain involvement of the CMHC’s communications plan that complies contact information for their staff and administrator and the psychiatric with both federal and state law. The for outside sources of assistance; registered nurse. For each CMHC, we CMHC also will have to review and alternate means of communication in estimate that complying with this update this plan at least annually. The case there is a disruption in phone requirement will require 8 burden hours communication plan must include the service to the facility (for example, cell at a cost of $637. Therefore, for all of the information listed in § 485.920(c)(1) phones); and a method for sharing CMHCs to comply with this requirement through (7). information and medical documentation will require an estimated 1,584 burden We expect that all CMHCs will with other healthcare providers to hours (8 burden hours for each CMHC compare their current emergency ensure continuity of care for their × 198 CMHCs) at a cost of $126,126 preparedness communications plan, if patients. However, we expect that all ($637 estimated cost for each CMHC × they have one, to the requirements. CMHCs will need to review, update, and 198 CMHCs).

TABLE 98—TOTAL COST ESTIMATE FOR A CMHC TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $94 4 $282 Psychiatric Registered Nurse ...... 71 5 355

Total ...... 8 637

We expect that CMHCs must also for CMHCs. As stated in the sections for their training program to review and update their emergency implementing regulations of the PRA at ensure it complies with the preparedness communication plan at 5 CFR 1320.3(b)(2), the time, effort, and requirements. least annually. For the purpose of financial resources necessary to comply The burden will be due to the determining the burden for this with a collection of information that resources the CMHC will need to requirement, we expect that CMHCs will be incurred by persons in the comply with the requirements. We will review their policies and normal course of their activities are not expect that complying with this procedures annually. We expect that all subject to the PRA. requirement will include the CMHCs have an administrator who is Section 485.920(d) will require involvement of a psychiatric registered responsible for the day-to-day operation CMHCs to develop and maintain an of the CMHC. This includes ensuring emergency preparedness training nurse. We expect that the psychiatric that all of the CMHC’s policies and program that must be reviewed and registered nurse will be primarily procedures are up-to-date and comply updated at least annually. We will involved in reviewing the CMHC’s with the relevant federal, state, and require the CMHC to meet the current training program, determining local laws, regulations, and ordinances. requirements contained in what tasks need to be performed or what We expect that the administrator is § 485.920(d)(1) and (2). materials need to be developed, and responsible for periodically reviewing We expect that CMHCs will develop developing the materials for the training the CMHC’s plans, policies, and a comprehensive emergency program. We estimate that it will require procedures as part of his or her preparedness training program. The 10 burden hours for each CMHC to responsibilities. In addition, we expect CMHCs will need to compare their develop a comprehensive emergency that an annual review of the current emergency preparedness training program at a cost of $710. communication plan will require only a training program and compare its Therefore, it will require an estimated negligible burden. Complying with the contents to the risk assessment and 1,980 burden hours (10 burden hours for requirement for an annual review of the updated emergency preparedness plan, each CMHC × 198 CMHCs) to comply emergency preparedness policies and procedures, and with this requirement at a cost of communications plan constitutes a communications plan and review, $140,580 ($710 estimated cost for each usual and customary business practice revise, and, if necessary, develop new CMHC × 198 CMHCs).

TABLE 99—TOTAL COST ESTIMATE FOR A CMHC TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Psychiatric Registered Nurse ...... $71 10 $710

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TABLE 99—TOTAL COST ESTIMATE FOR A CMHC TO DEVELOP A TRAINING PROGRAM—Continued

Position Hourly wage Burden hours Cost estimate

Total ...... 10 710

Section 485.920(d)(1) will also require will be incurred by persons in the and tests. For the purpose of the CMHCs to review and update their normal course of their activities are not determining a burden for these emergency preparedness training subject to the PRA. requirements, we will expect that all program at least annually. For the Section 485.920(d)(2) will require CMHCs need to develop two scenarios, purpose of determining the burden for CMHCs to participate in or conduct a one for the drill and one for the this requirement, we will expect that full-scale exercise at least annually. exercise, and develop the CMHCs will review their emergency CMHCs are also required to participate documentation necessary to record the preparedness training program in one additional testing exercise of facility’s responses. annually. We expect that all CMHCs their choice at least annually. CMHCs The associated burden will be the have a professional staff person, will be required to document the drills probably a psychiatric registered nurse, and the exercises. To comply with this time and effort necessary to comply who is responsible for periodically requirement, a CMHC will need to with the requirement. We expect that reviewing their training program to develop a specific scenario for each drill complying with this requirement will ensure that it is up-to-date and complies and exercise. A CMHC will have to likely require the involvement of a with the relevant federal, state, and develop the documentation necessary to psychiatric registered nurse. We expect local laws, regulations, and ordinances. record what happened during the drills that the psychiatric registered nurse will In addition, we expect that an annual and exercises. develop the documentation necessary review of the CMHC’s emergency Based on our experience with for both during the testing exercises and preparedness training program will CMHCs, we expect that all 198 CMHCs for the subsequent analysis of the require only a negligible burden. Thus, have some type of emergency CMHC’s response. The psychiatric we expect that complying with the preparedness training program and registered nurse will also develop the requirement for an annual review of the most, if not all, of these CMHCs already two scenarios for the drill and exercise. emergency preparedness training conduct some type of drill or exercise to We estimate that these tasks will require program constitutes a usual and test their emergency preparedness 4 burden hours at a cost of $284. For all customary business practice for CMHCs. plans. However, we do not know what 198 CMHCs to comply with this As stated in the implementing type of drills or exercises they typically requirement will require an estimated regulations of the PRA at 5 CFR conduct or how often they are 792 burden hours (4 burden hours for 1320.3(b)(2), the time, effort, and performed. We also do not know how, each CMHC × 198 CMHCs) at a cost of financial resources necessary to comply or if, they are documenting and $56,232 ($284 estimated cost for each with a collection of information that analyzing their responses to these drills CMHC × 198 CMHCs).

TABLE 100—TOTAL COST ESTIMATE FOR A CMHC TO CONDUCT TESTING

Position Hourly wage Burden hours Cost estimate

Psychiatric Registered Nurse ...... $71 4 $284

Total ...... 4 284

TABLE 101—BURDEN HOURS AND COST ESTIMATES FOR ALL 198 CMHCS TO COMPLY WITH THE ICRS CONTAINED IN § 485.920 EMERGENCY PREPAREDNESS

Hourly labor Total labor OMB Burden per Total annual cost of cost of Total cost Regulation section(s) Control No. Respondents Responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 485.920(a) ...... 0938–New ...... 198 198 5 990 ** 73,458 73,458 § 485.920(a)(1) ...... 0938–New ...... 198 198 10 1,980 ** 156,024 156,024 § 485.920(a)(1)–(4) ...... 0938–New ...... 198 198 15 2,970 ** 220,374 220,374 § 485.920(b) ...... 0938–New ...... 198 198 12 2,376 ** 186,912 186,912 § 485.920(c) ...... 0938–New ...... 198 198 8 1,584 ** 126,126 126,126 § 485.920(d)(1) ...... 0938–New ...... 198 198 10 1,980 ** 140,580 140,580 § 485.920(d)(2) ...... 0938–New ...... 198 198 4 792 ** 56,232 56,232

Totals ...... 198 1,188 ...... 12,672 ...... 959,706 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 101.

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Q. ICRs Regarding Condition of events they could experience both at improvement (QAPI) director, and an Participation: Emergency Preparedness their facilities and in the surrounding organ procurement coordinator (OPC). (§ 486.360) area, including branch offices and We expect that these individuals will Section 486.360(a) will require Organ hospitals in their donation services attend an initial meeting; review Procurement Organizations (OPOs) to areas. relevant sections of the current develop and maintain emergency The burden associated with this assessment, prepare and send their preparedness plans that will have to be requirement will be the time and effort comments to the QAPI director; attend reviewed and updated at least annually. necessary to perform a thorough risk a follow-up meeting; perform a final These plans will have to comply with assessment. Based on our experience review; and approve the new risk the requirements listed in with OPOs, we believe that all 58 OPOs assessment. We estimate that the QAPI have already performed at least some of § 486.360(a)(1) through (4). director probably will coordinate the the work needed for their risk As of June 2016, there are 58 OPOs. meetings, review the current risk assessments. However, these risk The current OPO Conditions for assessment, critique the risk assessment, Coverage (CfCs) are located at assessments may not be documented or may not address all of the elements coordinate comments, develop the new §§ 486.301 through 486.348. These CfCs risk assessment, and assure that the do not contain any specific emergency required under § 486.360(a). Therefore, necessary parties approved it. We preparedness requirements. Thus, for we expect that all 58 OPOs will have to the purpose of determining the burden, perform a thorough review of their estimate that it will require 10 burden we have analyzed the burden for all 58 current risk assessments and perform hours for each OPO to conduct a risk OPOs for all of the ICRs contained in the necessary tasks to ensure that their assessment at a cost of $1,190. this final rule. risk assessment complied with the Therefore, for all 58 OPOs to comply Section 486.360(a)(1) will require requirements of this final rule. Based on with the risk assessment requirement in OPOs to develop a documented, facility- our experience with OPOs, we believe this section will require an estimated based and community-based risk that conducting a risk assessment will 580 burden hours (10 burden hours for assessment utilizing an all-hazards require the involvement of the OPO’s each OPO × 58 OPOs) at a cost of approach. OPOs will need to identify director, medical director, quality $69,020 ($1,190 estimated cost for each the medical and non-medical emergency assessment and performance OPO × 58 OPOs).

TABLE 102—TOTAL COST ESTIMATE FOR AN OPO TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Director ...... $106 2 $212 Medical Director/Physician ...... 207 2 414 QAPI Director ...... 94 4 376 Organ Procurement Coordinator ...... 94 2 188

Total ...... 10 1,190

After conducting the risk assessment, will satisfy the requirements of this emergency preparedness plan, critique OPOs will then have to develop section. Therefore, we expect that all the emergency preparedness plan, emergency preparedness plans. The OPOs will need to review their current coordinate comments, ensure that the burden associated with this requirement emergency preparedness plans and appropriate individuals revise the plan, will be the resources needed to develop compare their plans to their risk and ensure that the necessary parties an emergency preparedness plan that assessments. Most OPOs will need to approve the new plan. revise, and in some cases develop, new complied with the requirements in Thus, we estimate that it will require sections to ensure their plan satisfied § 486.360(a)(1) through (4). We expect 22 burden hours for each OPO to that all OPOs have some type of the requirements. We expect that the same individuals develop an emergency preparedness emergency preparedness plan because it who were involved in the risk plan that complied with the is standard practice in the healthcare assessment will be involved in requirements of this section at a cost of industry to have a plan to address developing the emergency preparedness $2,568. The difference in burden common emergencies, such as fires. In plan. We expect that these individuals between the risk assessment and the addition, based on our experience with will attend an initial meeting, review plan requirement is greater in this OPOs (including the performance of the relevant sections of the OPO’s current section because OPOs have multiple Louisiana OPO during the Katrina emergency preparedness plan, prepare locations and personnel in various disaster), OPOs already have plans to and send their comments to the QAPI locations. Therefore, for all 58 OPOs to ensure that services will continue to be director, attend a follow-up meeting, comply with this requirement will provided in their donation service areas perform a final review, and approve the require an estimated 1,276 burden hours (DSAs) during an emergency. However, new plan. We expect that the QAPI (22 burden hours for each OPO × 58 we do not expect that all OPOs will Director will coordinate the meetings, OPOs) at a cost of $148,944 ($2,568 have emergency preparedness plans that perform an initial review of the current estimated cost for each OPO × 58 OPOs).

TABLE 103—TOTAL COST ESTIMATE FOR AN OPO TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Director ...... $106 4 $424 Medical Director/Physician ...... 207 4 828

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TABLE 103—TOTAL COST ESTIMATE FOR AN OPO TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN—Continued

Position Hourly wage Burden hours Cost estimate

QAPI Director ...... 94 10 940 Organ Procurement Coordinator ...... 94 4 376

Total ...... 22 2,568

The OPOs will also be required to will analyze the burden from this review of the plan and documentation review and update their emergency requirement for all OPOs. of the plan updates. We estimate that for preparedness plans at least annually. Based on our experience with OPOs, each OPO to comply will require 6 We believe that all of the OPOs already we expect that the same individuals burden hours at a cost of $689. Based on review their emergency preparedness who develop the emergency that estimate, it will require 348 burden plans periodically. However, the current preparedness plan will annually review hours (6 burden hours for each OPO CoPs do not include a requirement and update the plan. We expect that the organization × 58 organizations) at a for an emergency preparedness plan and QAPI director will spend more time cost of $39,962 ($689 estimated cost for as such, there is no requirement for an than the director, medical director, and each organization × 58 organizations). annual review of the plan. Therefore, we organ procurement coordinator on the

TABLE 104—TOTAL ESTIMATED COST FOR AN OPO TO REVIEW AND UPDATE AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Director ...... $106 1 $106 Medical Director/Physician ...... 207 1 207 QAPI Director ...... 94 3 282 Organ Procurement Coordinator ...... 94 1 94

Total ...... 6 689

Section 486.360(b) will require OPOs preparedness, we do not believe that the QAPI director, and an Organ to develop and maintain emergency OPOs have developed or implemented Procurement Coordinator (OPC). We preparedness policies and procedures all of the policies and procedures that expect that all of these individuals will based on their risk assessments, will be needed to comply with the review the OPO’s current policies and emergency preparedness plans, requirements of this section. procedures; compare them to the risk emergency communication plan as set The burden associated with the assessment, emergency preparedness forth in § 486.360(a)(1), (a), and (c), development of the emergency plan, agreements and protocols they respectively. It will also require OPOs to preparedness policies and procedures have established with hospitals, other review and update these policies and will be the resources needed to develop OPOs, and transplant programs; provide procedures at least annually. The OPO’s emergency preparedness policies and an analysis or comments; and policies and procedures must address procedures that will include, but will participate in developing the final the requirements listed at not be limited to, the specific elements version of the policies and procedures. § 486.360(b)(1) and (2). identified in this requirement. We The OPO CfCs already require the expect that all OPOs will need to review We expect that the QAPI director will OPOs’ governing body to develop and their current policies and procedures likely coordinate the meetings; oversee implementation of policies and and compare them to their risk coordinate and incorporate comments; procedures considered necessary for the assessments, emergency preparedness draft the revised or new policies and effective administration of the OPO, plans, emergency communication plans, procedures; and obtain the necessary including the OPO’s quality assessment and agreements and protocols; they signatures for final approval. We and performance improvement (QAPI) have developed as required by this final estimate that it will require 20 burden program, and services furnished under rule. Following their reviews, OPOs will hours for each OPO to comply with the contract or arrangement, including need to develop and implement the requirement to develop emergency agreements for those services policies and procedures necessary to preparedness policies and procedures at (§ 486.324(e)). Thus, we expect that ensure that they initiate and maintain a cost of $2,154. Therefore, for all 58 OPOs already have developed and their emergency preparedness plans, OPOs to comply with this requirement implemented policies and procedures agreements, and protocols. will require an estimated 1,160 burden for their effective administration. Based on our experience with OPOs, hours (20 burden hours for each OPO × However, since the current CfCs have no we expect that accomplishing these 58 OPOs) at a cost of $124,932 specific requirement that these policies activities will require the involvement (estimated cost for each OPO of $2,154 and procedures address emergency of the OPO’s director, medical director, × 58 OPOs).

TABLE 105—TOTAL COST ESTIMATE FOR AN OPO TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Director ...... $106 4 $424 Medical Director/Physician ...... 207 2 414

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TABLE 105—TOTAL COST ESTIMATE FOR AN OPO TO DEVELOP POLICIES AND PROCEDURES—Continued

Position Hourly wage Burden hours Cost estimate

QAPI Director ...... 94 8 752 Organ Procurement Coordinator ...... 94 6 564

Total ...... 20 2,154

The OPOs also will be required to hospitals, transplant programs, the OPO’s current plans, policies, and review and update their emergency Organ Procurement and Transplantation procedures related to communications preparedness policies and procedures at Network (OPTN), other healthcare and compare them to the OPO’s risk least annually. We believe that OPOs providers, other OPOs, and potential assessment, emergency plan, and the already review their emergency and actual donors’ next-of-kin. agreements and protocols the OPO preparedness policies and procedures Thus, we expect that the nature of developed in accordance with periodically. Therefore, we believe their work will ensure that all OPOs § 486.360(e), and the OPO’s emergency compliance with this requirement will have already addressed at least some of preparedness policies and procedures. constitute a usual and customary the elements that will be required by We expect that these individuals will business practice and will not be subject this section. For example, due to the review the materials described earlier, to the PRA in accordance with the necessity of communication with so submit comments to the QAPI director, implementing regulations of the PRA at many other entities, we expect that all review revisions and additions, and give 5 CFR 1320.3(b)(2). OPOs will have compiled names and a final recommendation or approval for Section 486.360(c) will require OPOs contact information for staff, other the new emergency preparedness to develop and maintain emergency OPOs, and transplant programs. communication plan. We also expect preparedness communication plans that We also expect that all OPOs will that the QAPI director will coordinate complied with both federal and state have alternate means of communication the meetings; compile comments; law. The OPOs will have to review and for their staffs. However, we do not incorporate comments into a new update their plans at least annually. The believe that all OPOs have developed communications plan, as appropriate; communication plans will have to formal plans that include all of the and ensure that the necessary include the information listed in elements contained in this requirement. individuals review and approve the new § 486.360(c)(1) through (3). The burden will be the resources The OPOs must operate 24 hours a needed to develop an emergency plan. day, 7 days a week. OPOs conduct much preparedness communications plan that We estimate that it will require 14 of their work away from their office(s) will include, but not be limited to, the burden hours to develop an emergency at various hospitals within their DSAs. specific elements identified in this preparedness communication plan at a To function effectively, OPOs must section. We expect that this will require cost of $1,566. Therefore, it will require ensure that they and their staff at these the involvement of the OPO director, an estimated 812 burden hours (14 multiple locations can communicate medical director, QAPI director, and burden hours for each OPO × 58 OPOs) with the OPO’s office(s), other OPO staff OPC. We expect that all of these at a cost of $90,828 ($1,566 estimated members, transplant and donor individuals will need to review the cost for each OPO × 58 OPOs).

TABLE 106—TOTAL COST ESTIMATE FOR AN OPO TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Director ...... $106 2 $212 Medical Director/Physician ...... 207 2 414 QAPI Director ...... 94 6 564 Organ Procurement Coordinator ...... 94 4 376

Total ...... 14 1,566

We proposed that OPOs must review preparedness training and testing must also ensure that their staff can and update their emergency programs. OPOs also will be required to demonstrate knowledge of their preparedness communication plans at review and update these programs at emergency procedures. Thereafter, least annually. We believe that all of the least annually. In addition, OPOs must OPOs will have to provide emergency OPOs already review their emergency meet the requirements listed in preparedness training at least annually. preparedness communication plans § 486.360(d)(1) and (2). Under existing regulations, OPOs are periodically. Thus, we believe In § 486.360(d)(1), we proposed that required to provide their staffs with the compliance with this requirement will OPOs be required to provide initial training and education necessary for constitute a usual and customary training in emergency preparedness them to furnish the services the OPO is business practice for OPOs and will not policies and procedures to all new and required to provide, including be subject to the PRA in accordance existing staff, individuals providing applicable organizational policies and with the implementing regulations of services under arrangement, and procedures and QAPI activities the PRA at 5 CFR 1320.3(b)(2). volunteers, consistent with their (§ 486.326(c)). However, since there are Section 486.360(d) will require OPOs expected roles, and maintain no specific emergency preparedness to develop and maintain emergency documentation of that training. OPOs requirements in the current OPO CfCs,

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we do not believe that the content of will review the OPO’s risk assessment, new emergency preparedness training their existing training will comply with emergency preparedness plan, policies program. the requirements. and procedures, and communication We estimate that it will require 40 We expect that OPOs will develop a plan and make recommendations burden hours for each OPO to develop comprehensive emergency preparedness regarding revisions or new sections an emergency preparedness training training program for their staffs. Based necessary to ensure that all appropriate program that complied with these upon our experience with OPOs, we information is included in the OPO’s requirements at a cost of $3,154. expect that complying with this emergency preparedness training. We Therefore, we estimate that for all 58 requirement will require the OPO believe that the OPO director, medical OPOs to comply with this requirement director, medical director, the QAPI director, and OPC will meet with the will require 2,320burden hours (40 director, an OPC, and the education QAPI director and education burden hours for each OPO × 58 OPOs) coordinator. We expect that the QAPI coordinator and assist in the review, at a cost of $203,812 ($3,514 estimated director and the education coordinator provide comments, and approve the cost for each OPO × 58 OPOs).

TABLE 107—TOTAL COST ESTIMATE FOR AN OPO TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Director ...... $106 2 $212 Medical Director/Physician ...... 207 2 414 QAPI Director ...... 94 12 1,128 Organ Procurement Coordinator ...... 94 8 752 Education Coordinator ...... 63 16 1,008

Total ...... 40 3,514

We proposed that OPOs must review their emergency plans, as needed. To requirements will constitute a usual and and update their emergency comply with this requirement, OPOs customary business practice and will preparedness training programs at least will have to develop scenarios for each not be subject to the PRA in accordance annually. We believe that all of the tabletop exercise and the necessary with the implementing regulations of OPOs already review their emergency documentation. the PRA at 5 CFR 1320.3(b)(2). preparedness training programs The OPO CfCs do not currently We expect that the QAPI director and periodically. Therefore, we believe contain a requirement for OPOs to the education coordinator will work compliance with this requirement will conduct a paper-based, tabletop together to develop the scenario for the constitute a usual and customary exercise. However, OPOs are required to exercise and the necessary business practice for OPOs and will not evaluate their staffs’ performance and documentation. We expect that the be subject to the PRA in accordance provide training to improve individual QAPI director will likely spend more with the implementing regulations of and overall staff performance and time on these activities. We estimate the PRA at 5 CFR 1320.3(b)(2). effectiveness (42 CFR 486.326(c)). that these tasks will require 5 burden Section 486.360(d)(2) will require Therefore, we expect that OPOs hours for each OPO at a cost of $408. OPOs to conduct a paper-based, tabletop periodically conduct some type of For all 58 OPOs to comply with these exercise at least annually. OPOs also exercise to test their plans, policies, and requirements will require an estimated will be required to analyze their procedures, which will include 290 burden hours (5 burden hours for responses to and maintain developing a scenario for and each OPO × 58 OPOs) at a cost of documentation of all tabletop exercises documenting the exercise. Thus, we $23,664 ($408 estimated cost for each and actual emergency events, and revise believe compliance with these OPO × 58 OPOs).

TABLE 108—TOTAL COST ESTIMATE FOR AN OPO TO CONDUCT TESTING

Position Hourly wage Burden hours Cost estimate

QAPI Director ...... $94 3 $282 Education Coordinator ...... 63 2 126

Total ...... 5 408

Section 486.360(e) requires OPOs to believe that most OPOs do not currently average number of transplant hospitals develop and maintain mutually agreed address emergency preparedness in for each DSA and the number of upon protocols as required in their protocols. OPOs will only be transplant programs in those hospitals. § 486.344(d) that cover the duties and required to address emergency There are about 770 transplant programs responsibilities of the transplant preparedness with the transplant and 234 transplant hospitals. For each program, the hospital in which the centers and the hospitals in which they OPO’s DSA, there is an average of 4 transplant program is operated and the operate. Since the number of transplant transplant hospitals (234 transplant OPO during an emergency. Section hospitals varies between the DSAs and hospitals/58 OPOs) with 3 transplant 486.344(d) does not currently require the number of transplant programs in programs (770 transplant programs/234 that emergency preparedness be each of those hospitals also varies, we transplant hospitals). Thus, we estimate addressed in those protocols. Thus, we have estimated the burden based on the that each OPO would need to develop

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protocols for 12 transplant programs (4 list patients and the transplant require 2 hours for each transplant transplant hospitals for each DSA × 3 recipients and the services that each of program. Thus, for each transplant transplant programs in each transplant them can provide during an emergency. program, the OPO would need 5 burden hospital). Based on our experience with OPOs, we hours at a cost of $595. As described The burden associated with this believe that conducting these previously, each OPO would need to requirement will be the time and effort negotiations would require the develop protocols for 12 transplant necessary to negotiate with each involvement of the OPO’s director, programs. Thus, to comply with this hospital and transplant program, and medical director, QAPI director, and an requirement, each OPO would require then draft the protocols that address organ procurement coordinator (OPC). 60 burden hours (5 burden hours × 12 each one’s duties and responsibilities We expect that these individuals would transplant programs) at a cost of $7,140 during an emergency. Based on our × experience with OPOs, transplant attend an initial meeting and then one ($595 for each transplant program 12 centers, and the hospitals in which they individual, probably the QAPI director, transplant programs). For all 58 OPOs, operate, we believe that they have would draft the protocols and ensure we estimate that the total burden to already had to deal with some type of they are reviewed by all required parties develop these protocols would be 3,480 emergency and have a basis for those and agreed to. This would require an burden hours (60 burden hours for each protocols, especially the types of hour of each individual’s time, except OPO × 58 OPOs) at a cost of $414,120 services that are needed by the waiting for the QAPI director who would ($7,140 for each OPO × 58 OPOs).

TABLE 109—TOTAL COST ESTIMATE FOR AN OPO TO DEVELOP AND MAINTAIN MUTUALLY AGREED UPON PROTOCOLS

Position Hourly wage Burden hours Cost estimate

Director ...... $106 1 $106 Medical Director/Physician ...... 207 1 207 QAPI Director ...... 94 2 188 Organ Procurement Coordinator ...... 94 1 94

Total ...... 5 595

Section 486.360(e) will also require location or office from which the OPO emergency plans under § 486.360(a), we each OPO to have the capability to could conduct its operations, or at least believe that virtually all of the OPOs continue its operations from an alternate those services the OPO has deemed will chose to comply with this location during an emergency. The OPO essential to provide, during an requirement by one of the two alternate can have an agreement with one or more emergency. An OPO could also satisfy methods being finalized. We estimate other OPOs to provide essential organ this requirement by having a plan, that about 9 OPOs or 15 percent of all procurement services to all or a portion which has been positively tested, to OPOs would chose to have an of the OPO’s DSA in the event that the locate to an alternate location during an agreement with another OPO. Since we OPO cannot provide such services due emergency as part of its emergency plan estimate that fewer than 10 OPOs would to an emergency. However, based upon as required by § 486.360(a). According chose to have an agreement with comments that we received, we are also to the commenters, some OPOs, another OPO, this requirement is not finalizing two alternate means by which especially those in DSAs that cover an OPO can also comply with this large geographical areas, already have subject to the PRA in accordance with requirement. An OPO with more than more than one office or location. In the implementing regulations of the one location or office would satisfy this addition, since OPOs will have to PRA at 5 CFR 1320.3(c). requirement if it had at least one other address continuity of operations in their TABLE 110—BURDEN HOURS AND COST ESTIMATES FOR ALL 58 OPOS TO COMPLY WITH THE ICRS CONTAINED IN § 486.360 EMERGENCY PREPAREDNESS

Hourly labor Total labor OMB Burden per Total annual cost of cost of Total cost Regulation section(s) Control No. Respondents Responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 486.360(a) ...... 0938–New ...... 58 58 6 348 ** 39,962 39,962 § 486.360(a)(1) ...... 0938–New ...... 58 58 10 580 ** 69,020 69,020 § 486.360(a)(2)–(4) ...... 0938–New ...... 58 58 22 1,276 ** 148,944 148,944 § 486.360(b) ...... 0938–New ...... 58 58 20 1,160 ** 124,932 124,932 § 486.360(c) ...... 0938–New ...... 58 58 14 812 ** 90,828 90,828 § 486.360(d)(1) ...... 0938–New ...... 58 58 40 2,320 ** 203,812 203,812 § 486.360(d)(2) ...... 0938–New ...... 58 58 5 290 ** 23,664 23,664 § 486.360(e) ...... 0938–New ...... 58 58 60 3,480 ** 414,120 414,120

Totals ...... 58 406 ...... 10,266 ...... 1,115,282 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 110.

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R. ICRs Regarding Condition for such are not requirements for FQHCs), requirements. For example, the Coverage and Condition for if HRSA finds that an FQHC is not expectations for FQHCs do not Certification: Emergency Preparedness meeting the expectations of the specifically address our requirement to (§ 491.12) Emergency Management PIN, it would address likely medical and non-medical provide the FQHC with resources for Section 491.12(a) will require Rural emergencies. In addition, participation technical assistance to assist them in Health Clinics (RHCs) and Federally in a community-based risk assessment is meeting these expectations. This Qualified Health Centers (FQHCs) to only encouraged, not required. We demonstrates the importance of the develop and maintain emergency expect that all 4,200 RHCs and 6,502 FQHC’s compliance with the Emergency preparedness plans. The RHCs and FQHCs will need to compare their Management PIN guidance. Therefore, FQHCs will also have to review and current risk assessments with our since the expectations in the Emergency update their plans at least annually. We requirements and accomplish the tasks Management PIN are a significant factor proposed that the plan must meet the necessary to ensure their risk in determining the burden for FQHCs, assessments comply with our requirements listed at § 491.12(a)(1) we will analyze the burden for the 7,300 through (4). requirements. However, we expect that FQHCs separately from the 4,200 RHCs FQHCs will not be subject to as many Section 491.12(a)(1) will require where the burden will be significantly burden hours as RHCs. RHCs/FQHCs to develop a documented, different. We have not designated any specific facility-based and community-based risk Based on our experience with RHCs, process or format for RHCs or FQHCs to assessment utilizing an all-hazards we expect that all 4,200 RHCs have use in conducting their risk assessments approach. RHCs/FQHCs will need to already performed at least some of the because we believe that RHCs and identify the medical and non-medical work needed to conduct a risk FQHCs need flexibility to determine the emergency events they could experience assessment. It is standard practice for best way to accomplish this task. both at their facilities and in the healthcare facilities to prepare for However, we expect that these surrounding area. RHCs/FQHCs will common emergencies, such as fires, healthcare facilities will include input need to review any existing risk power outages, and storms. In addition, from all of their major departments. assessments and then update and revise the current Rural Health Clinic those assessments or develop new Conditions for Certification and the Based on our experience with RHCs/ sections for them so that those FQHC Conditions for Coverage (RHC/ FQHCs, we expect that conducting the assessments complied with our FQHC CfCs) already require each RHC risk assessment will require the requirements. and FQHC to assure the safety of involvement of the RHC/FQHC’s We obtained the total number of RHCs patients in case of non-medical administrator, a physician, a nurse and FQHCs used in this burden analysis emergencies by taking other appropriate practitioner or physician assistant, and from the CMS CASPER data system, measures that are consistent with the a registered nurse. We expect that these which the states update periodically. particular conditions of the area in individuals will attend an initial Due to variations in the timeliness of the which the clinic or center is located meeting, review the current risk data submission, all numbers in this (§ 491.6(c)(3)). assessment, prepare and forward their analysis are approximate. There are Furthermore, in accordance with the comments to the administrator, attend a currently 11,500 RHC/FQHCs (4,200 Emergency Management PIN, FQHCs follow-up meeting, perform a final RHCs + 7,300 FQHCs). Unlike RHCs, should have initiated their ‘‘emergency review, and approve the new risk FQHCs are grantees and look-alikes management planning by conducting a assessment. We expect that the under HRSA’s Health Center Program. risk assessment such as a Hazard administrator will coordinate the In 2007, the Health Resources and Vulnerability Analysis’’ (HVA) meetings, review the current risk Services Administration (HRSA) issued (Emergency Management PIN, p. 5). The assessment, provide an analysis of the a Policy Information Notice (PIN) HVA should identify potential risk assessment, offer suggested entitled ‘‘Health Center Emergency emergencies or risks and potential direct revisions, coordinate comments, Management Program Expectations,’’ and indirect effects on the facility’s develop the new risk assessment, and that detailed the expectations HRSA has operations and demands on their ensure that the necessary parties for health centers related to emergency services and prioritize the risks based approve it. We also expect that the management (‘‘Health Center Emergency on the likelihood of each risk occurring administrator will spend more time Management Program Expectations,’’ and the impact or severity the facility reviewing the risk assessment than the Policy Information Notice (PIN), will experience if the risk occurs other individuals. Document Number 2007–15, HRSA, (Emergency Management PIN, p. 5). We estimate that it will require 10 August 22, 2007) (Emergency FQHCs are also ‘‘encouraged to burden hours for each RHC to conduct Management PIN). A review of the participate in community level risk a risk assessment that complied with the Emergency Management PIN indicates assessments and integrate their own risk requirements in this section at a cost of that some of its expectations are very assessment with the local community’’ $1,080. We estimate that for all RHCs to similar to the requirements in this final (Emergency Management PIN, p. 5). comply with our requirements will rule. While the expectations set forth by Despite these expectations and the require 42,000 burden hours (10 burden HRSA in the Emergency Management existing Medicare regulations for RHCs/ hours for each RHC × 4,200 RHCs) at a PIN are not requirements for receiving a FQHCs, some RHC/FQHC risk cost of $4,536,000 ($1,080 estimated HRSA Center Program grant (and as assessments may not comply with all cost for each RHC × 4,200 RHCs).

TABLE 111—TOTAL ESTIMATED COST FOR A RHC TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 4 $388 Medical Director/Physician ...... 181 2 362 Nurse Practitioner/Physician Assistant ...... 94 2 188

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TABLE 111—TOTAL ESTIMATED COST FOR A RHC TO CONDUCT A RISK ASSESSMENT—Continued

Position Hourly wage Burden hours Cost estimate

Registered Nurse ...... 71 2 142

Total ...... 10 1,080

We estimate that it will require 5 comply will require 36,500 burden compliance with this requirement for all burden hours for each FQHC to conduct hours (5 burden hours for each FQHC × RHCs and FQHCs will require 78,500 a risk assessment that complied with 7,300 FQHCs) at a cost of $3,796,000 burden hours at a cost of $8,332,000. our requirements at a cost of $520. We ($520 estimated cost for each FQHC × estimate that for all 7,300 FQHCs to 7,300 FQHCs). Based on those estimates,

TABLE 112—TOTAL ESTIMATED COST FOR AN FQHC TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 2 $194 Medical Director/Physician ...... 181 1 181 Nurse Practitioner/Physician Assistant ...... 94 1 94 Registered Nurse ...... 51 1 51

Total ...... 5 520

After conducting the risk assessment, FQHC’s emergency management plan expect that FQHCs will have less of a RHCs/FQHCs will have to develop and (EMP). For example, it states that the burden than RHCs. maintain emergency preparedness plans FQHC’s EMP ‘‘is necessary to ensure the Based on our experience with RHCs/ that complied with § 491.12(a)(1) continuity of patient care’’ during an FQHCs, we expect that the same through (4) and review and update them emergency (Emergency Management individuals who were involved in annually. It is standard practice for PIN, p. 6) and should contain plans for developing the risk assessments will be healthcare facilities to plan for common ‘‘assuring access for special populations involved in developing the emergency emergencies, such as fires, hurricanes, (Emergency Management PIN, p. 7). The preparedness plans. However, we and snowstorms. In addition, as FQHC’s EMP also should address expect that it will require more time to discussed earlier, we require all RHCs/ continuity of operations, as appropriate FQHCs to take appropriate measures to (Emergency Management PIN, p. 6). In complete the plans than the risk ensure the safety of their patients in addition, FQHCs should use an ‘‘all- assessments. We expect that the non-medical emergencies, based on the hazards approach’’ so that these administrator will have primary particular conditions present in the area facilities can respond to all of the risks responsibility for reviewing and in which they are located (§ 491.6(c)(3)). they identified in their risk assessment developing the RHC/FQHC’s EMP. We Thus, we expect that all RHCs/FQHCs (Emergency Management PIN, p. 6). expect that the physician, nurse have developed some type of emergency Based on the expectations in the practitioner or physician assistant, and preparedness plan. However, under this Emergency Management PIN, we expect registered nurse will review the draft final rule, all RHCs/FQHCs will have to that FQHCs likely have developed plan and provide comments to the review their current plans and compare emergency preparedness plans that administrator. We estimate that for each them to their risk assessments. The comply with many, if not all, of the RHC to comply with this requirement RHCs/FQHCs will need to update, elements with which their plans will will require 14 burden hours at a cost revise, and, in some cases, develop new need to comply under this final rule. of $1,379. Therefore, it will require an sections to complete their emergency However, we expect that FQHCs will estimated 58,800 burden hours (14 preparedness plans that meet our need to compare their current EMP to burden hours for each RHC × 4,200 requirements. our requirements and, if necessary, RHCs) to complete the plan at a cost of The Emergency Management PIN revise or develop new sections for their $5,791,800 ($1,379 estimated cost for contains many expectations for an EMP to bring it into compliance. We each RHC × 4,200 RHCs).

TABLE 113—TOTAL ESTIMATED COST FOR A RHC TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 6 $582 Medical Director/Physician ...... 181 2 362 Nurse Practitioner/Physician Assistant ...... 94 3 282 Registered Nurse ...... 51 3 153

Total ...... 14 1,379

We estimate that it will require 8 with our requirements at a cost of $762. 58,400 burden hours (8 burden hours for burden hours for each FQHC to comply Based on that estimate, it will require each FQHC × 7,300 FQHCs) to complete

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the plan at a cost of $5,562,600 ($762 estimated cost for each FQHC × 7,300 FQHCs).

TABLE 114—TOTAL ESTIMATED COST FOR A FQHC TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 3 $291 Medical Director/Physician ...... 181 1 181 Nurse Practitioner/Physician Assistant ...... 94 2 188 Registered Nurse ...... 51 2 102

Total ...... 8 762

Based on the previous estimates, for We expect that all RHCs/FQHCs have security of medical records (Emergency all RHCs and FQHCs to develop an some emergency preparedness policies Management PIN, p. 6). In addition, emergency preparedness plan that and procedures. All RHCs and FQHCs FQHCs should also continually evaluate complies with our requirements will are required to have emergency their EMPs and make changes to their require 117,200 burden hours at a cost procedures related to the safety of their EMPs as necessary (Emergency of $11,354,400. patients in non-medical emergencies Management PIN, p. 7). These Each RHC/FQHC also will be required (§ 491.6(c)). They also must set forth in expectations also indicate that FQHCs to review and update its emergency writing their organization’s policies should be working with and integrating preparedness plan at least annually. We (§ 491.7(a)(2)). In addition, current their planning with their state and local believe that RHCs and FQHCs already regulations require that a physician, in communities’ plans, as well as other key review their emergency preparedness conjunction with a nurse practitioner or organizations and other relationships physician’s assistant, develop the plans periodically. Thus, we believe (Emergency Management PIN, p. 8). facility’s written policies (§ 491.8(b)(ii) compliance with this requirement will Thus, we expect that burden for FQHCs and (c)(i)). However, we expect that all constitute a usual and customary from the requirement for emergency RHCs/FQHCs will need to review their business practice for RHCs and FQHCs preparedness policies and procedures policies and procedures, assess whether and will not be subject to the PRA in will be less than the burden for RHCs. their policies and procedures accordance with the implementing incorporate their risk assessments and The burden associated with our regulations of the PRA at 5 CFR emergency preparedness plans and requirements will be reviewing, 1320.3(b)(2). make any changes necessary to comply revising, and, if needed, developing new Section 491.12(b) will require RHCs/ with our requirements. emergency preparedness policies and FQHCs to develop and implement We expect that FQHCs already have procedures. We expect that a physician emergency preparedness policies and policies and procedures that will and a nurse practitioner will primarily procedures based on their emergency comply with some of our requirements. be involved with these tasks and that an plans, risk assessments, and Several of the expectations of the administrator will assist them. We communication plans as set forth in Emergency Management PIN address estimate that for each RHC to comply § 491.12(a), (a)(1), and (c), respectively. specific elements in § 491.12(b). For with our requirements will require 12 We will also require RHCs/FQHCs to example, the PIN states that FQHCs burden hours at a cost of $1,482. Based review and update these policies and should address, as appropriate, on that estimate, for all 4,200 RHCs to procedures at least annually. At a continuity of operations, staffing, surge comply with these requirements will minimum, we will require that the RHC/ patients, medical and non-medical require 50,400 burden hours (12 burden FQHC’s policies and procedures address supplies, evacuation, power supply, hours for each RHC × 4,200 RHCs) at a the requirements listed at § 491.12(b)(1) water and sanitation, communications, cost of $6,224,400 ($1,482 estimated through (4). transportation, and the access to and cost for each RHC × 4,200 RHCs).

TABLE 115—TOTAL ESTIMATED COST FOR A RHC TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 2 $194 Medical Director/Physician ...... 181 4 724 Nurse Practitioner/Physician Assistant ...... 94 6 564

Total ...... 12 1,482

As discussed earlier, we expect that Emergency Management PIN. Thus, we comply with these requirements will FQHCs will have less of a burden from estimate that for each FQHC to comply require 58,400 burden hours (8 burden developing their emergency with the requirements will require 8 hours for each FQHC × 7,300 FQHCs) at preparedness policies and procedures burden hours at a cost of $932. Based on a cost of $6,803,600 ($932 estimated due to the expectations set out in the that estimate, for all 7,300 FQHCs to cost for each FQHC × 7,300 FQHCs).

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TABLE 116—TOTAL ESTIMATED COST FOR A FQHC TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 2 $194 Medical Director/Physician ...... 181 2 362 Nurse Practitioner/Physician Assistant ...... 94 4 376

Total ...... 8 932

Based on the previous estimates, for for patients. As discussed earlier, RHCs of our requirements. However, we all RHCs and FQHCs to develop and FQHCs are required to take expect that all FQHCs will need to emergency preparedness policies and appropriate measures to ensure the review, revise, and, if needed, develop procedures that comply with our safety of their patients during non- new sections for their emergency requirements will require 108,800 medical emergencies (§ 491.6(c)). We preparedness communication plans to burden hours at a cost of $13,028,000. expect that an emergency preparedness ensure that their plans are in We proposed that RHCs/FQHCs communication plan will be an essential compliance. We expect that these tasks review and update their emergency element in any emergency preparedness will require less of a burden for FQHCs preparedness policies and procedures at preparations. However, some RHCs/ than for the RHCs. least annually. We believe that RHCs FQHCs may not have a formal, written The burden associated with and FQHCs already review their emergency preparedness complying with this requirement will be emergency preparedness policies and communication plan or their plan may the resources required to review, revise, procedures periodically. Therefore, we not include all the requirements we and, if needed, develop new sections for believe compliance with this proposed. the RHC/FQHC’s emergency requirement will constitute a usual and The Emergency Management PIN preparedness communication plan. customary business practice for RHCs/ contains specific expectations for Based on our experience with RHCs/ FQHCs and will not be subject to the communications and information FQHCs, as well as the requirements in PRA in accordance with the sharing (Emergency Management PIN, current regulations for a physician to implementing regulations of the PRA at pp. 8–9). ‘‘A well-defined work in conjunction with a nurse 5 CFR 1320.3(b)(2). communication plan is an important Section 491.12(c) will require RHCs/ component of an effective EMP’’ practitioner or a physician assistant to FQHCs to develop and maintain an (Emergency Management PIN, p. 8). In develop policies, we anticipate that emergency preparedness addition, FQHCs are expected to have satisfying the requirements in this communication plan that complied with policies and procedures for section will require the involvement of both federal and state law. RHCs/FQHCs communicating with both internal the RHC/FQHC’s administrator, a will also have to review and update stakeholders (such as patients and staff) physician, and a nurse practitioner or these plans at least annually. We and external stakeholders (such as physician assistant. We expect that the proposed that the communication plan federal, tribal, state, and local agencies), administrator and the nurse practitioner must include the information listed in and for identifying who will do the or physician assistant will be primarily § 491.12(c)(1) through (5). communicating and what type of involved in reviewing, revising, and if We expect that all RHCs/FQHCs have information will be communicated needed, developing new sections for the some type of emergency preparedness (Emergency Management PIN, p. 8). RHC/FQHC’s emergency preparedness communication plan. It is standard FQHCs should also identify alternate communication plan. practice for healthcare facilities to communications systems in the event We estimate that for each RHC to maintain contact information for staff that their standard communications comply with the requirements will and outside sources of assistance; systems become unavailable, and the require 10 burden hours at a cost of alternate means of communication in FQHC should identify these alternate $1,126. Based on that estimate, for all case there is an interruption in the systems in their EMP (Emergency 4,200 RHCs to comply will require facility’s phone services; and a method Management PIN, p. 9). Thus, we expect 42,000 burden hours (10 burden hours for sharing information and medical that all FQHCs will have a formal for each RHC × 4,200 RHCs) at a cost of documentation with other healthcare communication plan for emergencies $4,729,200 ($1,126 estimated cost for providers to ensure continuity of care and that those plans will contain some each RHC × 4,200 RHCs).

TABLE 117—TOTAL ESTIMATED COST FOR A RHC TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 4 $388 Medical Director/Physician ...... 181 2 362 Nurse Practitioner/Physician Assistant ...... 94 4 376

Total ...... 10 1,126

We estimate that for a FQHC to Based on this estimate, for all 7,300 FQHC × 7,300 FQHCs) at a cost of comply with the requirements will FQHCs to comply will require 36,500 $4,109,900 ($563 estimated cost for each require 5 burden hours at a cost of $563. burden hours (5 burden hours for each FQHC × 7,300 FQHCs).

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TABLE 118—TOTAL ESTIMATED COST FOR A FQHC TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 2 $194 Medical Director/Physician ...... 181 1 181 Nurse Practitioner/Physician Assistant ...... 94 2 188

Total ...... 5 563

We proposed that RHCs/FQHCs also knowledge of those emergency We expect that each RHC and FQHC review and update their emergency procedures. Thereafter, each RHC and has a professional staff person who is preparedness communication plans at FQHC will be required to provide responsible for ensuring that the least annually. We believe that RHCs/ emergency preparedness training facility’s training program is up-to-date FQHCs already review their emergency annually. and complies with all federal, state, and preparedness communication plans Based on our experience with RHCs local laws and regulations. This periodically. Thus, we believe and FQHCs, we expect that all 11,500 individual will likely be an compliance with this requirement will RHC/FQHCs already have some type of administrator. We expect that the constitute a usual and customary emergency preparedness training administrator will be primarily involved business practice for RHCs/FQHCs and program. The current RHC/FQHC in reviewing the RHC/FQHC’s will not be subject to the PRA in regulations require RHCs and FQHCs to emergency preparedness program; provide training to their staffs on accordance with the implementing determining what tasks need to be handling emergencies (§ 491.6(c)(1)). In regulations of the PRA at 5 CFR performed and what materials need to 1320.3(b)(2). addition, FQHCs are expected to be developed to bring the training Section 491.12(d) will require RHCs/ provide ongoing training in emergency FQHCs to develop and maintain management and their facilities’ EMP to program into compliance with our emergency preparedness training and all of their employees (Emergency requirements; and making changes to testing programs and review and update Management PIN, p. 7). However, current training materials and these programs at least annually. We neither the current regulations nor the developing new training materials. We proposed that an RHC/FQHC will have PIN’s expectations for FQHCs address expect that the administrator will work to comply with the requirements listed initial training and ongoing training, with a registered nurse to develop the in § 491.12(d)(1) and (2). frequency of training, or requirements revised and updated training program. Section 491.12(d)(1) will require each that individuals providing services We estimate that it will require 10 RHC and FQHC to provide initial under arrangement and volunteers be burden hours for each RHC or FQHC to training in emergency preparedness included in the training. RHCs/FQHCs develop a comprehensive emergency policies and procedures to all new and will need to review their current training program at a cost of $602. existing staff, individuals providing training programs; compare their Therefore, it will require an estimated services under arrangement, and contents to their risk assessments, 115,500 burden hours (10 burden hours volunteers, consistent with their emergency preparedness plans, policies for each RHC/FQHC × 11,500 RHCs/ expected roles, and maintain and procedures, and communication FQHCs) to comply with this documentation of that training. Each plans and then take the necessary steps requirement at a cost of $6,923,000 RHC and FQHC will also have to ensure to ensure that their training programs ($602 estimated cost for each RHC/ that its staff could demonstrate comply with our requirements. FQHC × 11,500 RHCs/FQHCs).

TABLE 119—TOTAL ESTIMATED COST FOR A RHC/FQHC TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 2 $194 Nurse Practitioner/Physician Assistant ...... 51 8 408

Total ...... 10 602

Section 491.12(d) will also require implementing regulations of the PRA at actual natural or man-made emergency that RHCs/FQHCs develop and maintain 5 CFR 1320.3(b)(2). that required activation of its emergency emergency preparedness training and Section 491.12(d)(2) will require plan, it will be exempt from the testing programs that will be reviewed RHCs/FQHCs to participate in a full- requirement for a community or and updated at least annually. We scale exercise at least annually. They individual, facility-based full-scale believe that RHCs/FQHCs already will also be required to participate in an exercise for 1 year following the onset review their emergency preparedness additional testing exercise of their of the actual event. However, for programs periodically. Therefore, we choice at least annually. RHCs/FQHCs purposes of determining the burden for believe compliance with this will also be required to analyze their these requirements, we will assume that requirement will constitute a usual and responses to and maintain all RHCs/FQHCs will have to comply customary business practice for RHCs/ documentation of drills, tabletop with all of these requirements. FQHCs and will not be subject to the exercises, and emergency events, and The burden associated with PRA in accordance with the revise their emergency plans, as needed. complying with these requirements will If an RHC or FQHC experienced an be the resources the RHC or FQHC will

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need to develop the scenarios for the Management PIN, p. 7). However, we do We expect that the administrator and a drill and exercise and the not believe that all RHCs/FQHCs have registered nurse will be primarily documentation necessary for analyzing the appropriate documentation for the involved in accomplishing these tasks. and documenting their drills, tabletop testing exercises and emergency events We estimate that for each RHC/FQHC to exercises, as well as any emergency or that they conduct both two testing comply with the requirements in this events. exercises annually. Thus, we will section will require 5 burden hours at a Based on our experience with RHCs/ analyze the burden associated with cost of $347. Based on this estimate, for FQHCs, we expect that most of the these requirements for all 11,500 RHCs/ all 11,500 RHCs/FQHCs to comply with 11,500 RHCs/FQHCs already conduct FQHCs. the requirements in this section will some type of testing of their emergency Based on our experience with RHCs/ require 57,500 burden hours (5 burden preparedness plans and develop FQHCs, we expect that the same × scenarios and documentation for their individuals who are responsible for hours for each RHC/FQHC 11,500 testing and emergency events. For developing the RHC/FQHC’s training RHCs/FQHCs) at a cost of $3,990,500 example, FQHCs are expected to and testing program will develop the ($347 estimated cost for each RHC/ × conduct some type of testing of their scenarios for the drills and exercises FQHC 11,500 RHC/FQHCs). EMP at least annually (Emergency and the accompanying documentation.

TABLE 120—TOTAL ESTIMATED COST FOR A RHC/FQHC TO CONDUCT TESTING

Position Hourly wage Burden hours Cost estimate

Administrator ...... $97 2 $194 Nurse Practitioner/Physician Assistant ...... 51 3 153

Total ...... 5 347

TABLE 121—BURDEN HOURS AND COST ESTIMATES FOR ALL 11,500 RHC/FQHCS TO COMPLY WITH THE ICRS CONTAINED IN § 491.12 CONDITION: EMERGENCY PREPAREDNESS

Hourly labor Total labor OMB Burden per Total annual cost of cost of Total cost Regulation section(s) Control No. Respondents Responses response burden reporting reporting ($) (hours) (hours) ($) ($)

§ 491.12(a)(1) (RHCs) ...... 0938–New ...... 4,200 4,200 10 42,000 ** 4,536,000 4,536,000 § 491.12(a)(1) (FQHCs) ...... 0938–New ...... 7,300 7,300 5 36,500 ** 3,796,000 3,796,000 § 491.12(a)(1)–(4) (RHCs) ...... 0938–New ...... 4,200 4,200 14 58,800 ** 5,791,800 5,791,800 § 491(a)(1)–(4) (FQHCs) ...... 0938–New ...... 7,300 7,300 8 58,400 ** 5,562,600 5,562,600 § 491.12(b) (RHCs) ...... 0938–New ...... 4,200 4,200 12 50,400 ** 6,224,400 6,224,400 § 491.12(b) (FQHCs) ...... 0938–New ...... 7,300 7,300 8 58,400 ** 6,803,600 6,803,600 § 491.12(c) (RHCs) ...... 0938–New ...... 4,200 4,200 10 42,000 ** 4,729,200 4,729,200 § 491.12(c) (FQHCs) ...... 0938–New ...... 7,300 7,300 5 36,500 ** 4,109,900 4,109,900 § 491.12(d)(1) ...... 0938–New ...... 11,500 11,500 10 115,000 ** 6,923,000 6,923,000 § 491.12(d)(2) ...... 0938–New ...... 11,500 11,500 5 57,500 ** 3,990,500 3,990,500

Totals ...... 11,500 11,500 ...... 555,500 ...... 52,467,000 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 121.

S. ICRs Regarding Condition of including, but not limited to, persons-at- disasters likely to occur in the facility’s Participation: Emergency Preparedness risk; and the types of services the geographic area (§ 494.60(d)). Thus, to (§ 494.62) dialysis facility has the ability to be in compliance with this CfC, we Section 494.62(a) will require dialysis provide in an emergency. The dialysis believe that all dialysis facilities will facilities to develop and maintain facility also will need to identify the have already performed some type of emergency preparedness plans that will measures it will need to take to ensure risk assessment during the process of have to reviewed and updated at least the continuity of its operations, developing their emergency annually. Section 494.62 will require including delegations of authority and preparedness processes and procedures. that the plan include the elements set succession plans. However, these risk assessments may out at § 494.62(a)(1) through (4). The burden associated with this not be as thorough or address all of the Section 494.62(a)(1) will require requirement will be the resources elements required in § 494.62(a). For dialysis facilities to develop a needed to perform a thorough risk example, the current CfCs do not require documented, facility-based and assessment. The current CfCs already dialysis facilities to plan for man-made community-based risk assessment require dialysis facilities to implement disasters. Therefore, we believe that all utilizing an all-hazards approach. The processes and procedures to manage dialysis facilities will have to conduct a risk assessment should address the medical and nonmedical emergencies thorough review of their current risk medical and non-medical emergency that are likely to threaten the health or assessments and then perform the events the facility could experience both safety of the patients, the staff, or the necessary tasks to ensure that their within the facility and within the public. These emergencies include, but facilities’ risk assessments complied surrounding area. The dialysis facility are not limited to, fire, equipment or with the requirements of this section. will have to consider its location and power failure, care-related emergencies, Based on our experience with dialysis geographical area; patient population, water supply interruption, and natural facilities, we expect that conducting the

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risk assessment will require the administrator will probably coordinate assessment. Thus, we estimate that involvement of the dialysis facility’s the meetings, do an initial review of the complying with this requirement to chief executive officer or administrator, current risk assessment, provide a conduct and develop a risk assessment medical director, nurse manager, social critique of the risk assessment, offer will require 12 burden hours at a cost worker, and a patient care technician suggested revisions, coordinate of $1,206. There are currently 6,648 (PCT). We believe that all of these comments, develop the new risk dialysis facilities. Therefore, it will individuals will attend an initial assessment, and assure that the require an estimated 79,776 burden meeting, review relevant sections of the necessary parties approve the new risk hours (12 burden hours for each dialysis current assessment, develop comments assessment. We also believe that the facility × 6,648 dialysis facilities) for all and recommendations for changes to the administrator will probably spend more dialysis facilities to comply with this assessment, attend a follow-up meeting, time reviewing and working on the risk requirement at a cost of $8,017,488 perform a final review and approve the assessment than the other individuals ($1,206 estimated cost for each dialysis risk assessment. We believe that the involved in performing the risk facility × 6,648 dialysis facilities).

TABLE 122—TOTAL COST ESTIMATE FOR A DIALYSIS FACILITY TO CONDUCT A RISK ASSESSMENT

Position Hourly wage Burden hours Cost estimate

Administrator ...... $106 4 $424 Medical Director/Physician ...... 207 2 414 Nurse Manager ...... 94 2 188 Social Worker ...... 51 2 102 Patient Care Dialysis Technician ...... 39 2 78

Total ...... 12 1,206

After conducting the risk assessment, some cases, develop new sections to assessment, offer suggested revisions, each dialysis facility will then have to complete an emergency preparedness coordinate comments, develop the new develop and maintain an emergency plan that addressed the risks identified risk assessment, and assure that the preparedness plan that the facility must in their risk assessment and the specific necessary parties approved the new risk evaluate and update at least annually. requirements contained in this section. assessment. We also believe that the This emergency plan will have to The plan will also address how the administrator, medical director, and comply with the requirements at dialysis facility will continue providing nurse manager will probably spend § 494.62(a)(1) through (4). its essential services, which are the more time reviewing and working on Current CfCs already require dialysis services that the dialysis facility will the risk assessment than the other facilities to have a plan to obtain continue to provide despite an individuals involved in developing the emergency medical system assistance emergency. The dialysis facility will plan. The social worker and PCT will when needed and to evaluate at least also need to review, revise, and, in some likely just review the plan or relevant annually the effectiveness of emergency cases, develop delegations of authority sections of it. In addition, since the and disaster plans and update them as or succession plans that the dialysis medical director’s responsibilities necessary (§ 494.60(d)(4)). Thus, we facility determined were necessary for include participation in the expect that all dialysis facilities have the appropriate initiation and development of patient care policies some type of emergency preparedness or management of their emergency and procedures (42 CFR 494.150(c)), we disaster plan. In addition, dialysis preparedness plan. expect that the medical director will be facilities must implement processes and The burden associated with this involved in the development of the procedures to manage medical and requirement will be the time and effort emergency preparedness plan. This is nonmedical emergencies that are likely necessary to develop the emergency less time than we estimate it will take to threaten the health or safety of the preparedness plan. Based upon our for the risk assessment because dialysis patients, the staff, or the public. These experience with dialysis facilities, we facilities are currently required to have emergencies include, but are not limited expect that developing the emergency an emergency plan (§ 494.60(d)(4)). to, fire, equipment or power failures, preparedness plan will require the Based on this final rule, the dialysis care-related emergencies, water supply involvement of the dialysis facility’s facility will need to update, revise, and, interruption, and natural disasters likely chief executive officer or administrator, in some cases, develop new sections to to occur in the facility’s geographic area medical director, nurse manager, social complete an emergency preparedness (§ 494.60(d)). We expect that the facility worker, and a PCT. We believe that all plan that addresses the risks identified will incorporate many, if not all, of of these individuals will probably have in their risk assessment and the specific these processes and procedures into its to attend an initial meeting, review requirements contained in this emergency preparedness plan. We relevant sections of the facility’s current regulation. expect that each dialysis facility has emergency preparedness or disaster some type of emergency preparedness plan(s), develop comments and We estimate that complying with this plan and that plan should already recommendations for changes to the requirement will require 10 burden address many of these requirements. assessment, attend a follow-up meeting, hours at a cost of $1,116 for each However, all of the dialysis facilities and then perform a final review and dialysis facility. There are 6,648 dialysis will have to review their current plans approve the risk assessment. We believe facilities. Therefore, it will require an and compare them to the risk that the administrator will probably estimated 66,480 burden hours (10 assessment they performed according to coordinate the meetings, do an initial burden hours for each dialysis facility × § 494.62(a)(1). The dialysis facility will review of the current risk assessment, 6,648 dialysis facilities) to complete the then need to update, revise, and, in provide a critique of the risk plan at a cost of $7,419,168 ($1,116

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estimated cost for each dialysis facility × 6,648 dialysis facilities).

TABLE 123—TOTAL COST ESTIMATE FOR A DIALYSIS FACILITY TO DEVELOP AN EMERGENCY PREPAREDNESS PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $106 4 $424 Medical Director/Physician ...... 207 2 414 Nurse Manager ...... 94 2 188 Social Worker ...... 51 1 51 Patient Care Dialysis Technician ...... 39 1 39

Total ...... 10 1,116

Each dialysis facility will also be review and update these policies and elements of their emergency required to review and update its procedures at least annually. The preparedness program, and then, if emergency preparedness plan at least policies and procedures will be required necessary, take the appropriate steps to annually. We believe that dialysis to address, at a minimum, the ensure that their policies and facilities already review their emergency requirements listed at § 494.62(b)(1) procedures encompassed these preparedness plans periodically. The through (9). requirements. current CfCs already requires dialysis We expect that all dialysis facilities The burden associated with the facilities to evaluate the effectiveness of have some emergency preparedness development of these emergency their emergency and disaster plans and policies and procedures. The current policies and procedures will be the time update them as necessary (42 CFR CfCs at § 494.60(d) already require 494.60(d)(4)(ii)). Thus, we believe dialysis facilities to implement and effort necessary to comply with compliance with this requirement will processes and procedures to manage these requirements. We expect the constitute a usual and customary medical and nonmedical emergencies administrator, medical director, and the business practice and will not be subject that include, but not limited to, fire, nurse manager will be primarily to the PRA in accordance with the equipment or power failures, care- involved with reviewing, revising, and implementing regulations of the PRA at related emergencies, water supply if needed, developing any new policies 5 CFR 1320.3(b)(2). interruption, and natural disasters likely and procedures that were needed. The Section 494.62(b) will require dialysis to occur in the facility’s geographic area. remaining individuals will likely review facilities to develop and implement In addition, we expect that dialysis the sections of the policies and emergency preparedness policies and facilities already have procedures that procedures that directly affect their procedures based on the emergency will satisfy some of the requirements in areas of expertise. Therefore, we plan, the risk assessment, and this section. For example, each dialysis estimate that complying with this communication plan as set forth in facility is already required at requirement will require 10 burden § 494.62(a), (a)(1), and (c), respectively. § 494.60(d)(4)(iii) to contact its local hours at a cost of $1,116 for each These emergencies will include, but disaster management agency at least dialysis facility. There are 6,648 dialysis will not be limited to, fire, equipment or annually to ensure that such agency is facilities. Therefore, it will require an power failures, care-related aware of dialysis facility needs in the estimated 66,480 burden hours (10 emergencies, water supply event of an emergency. However, all burden hours for each dialysis facility × interruptions, and natural and man- dialysis facilities will need to review 6,648 dialysis facilities) to complete the made disasters that are likely to occur their policies and procedures, assess plan at a cost of $7,419,168 ($1,116 in the facility’s geographical area. whether their policies and procedures estimated cost for each dialysis facility Dialysis facilities will also have to incorporated all of the necessary × 6,648 dialysis facilities).

TABLE 124—TOTAL COST ESTIMATE FOR A DIALYSIS FACILITY TO DEVELOP POLICIES AND PROCEDURES

Position Hourly wage Burden hours Cost estimate

Administrator ...... $106 4 $424 Medical Director/Physician ...... 207 2 414 Nurse Manager ...... 94 2 188 Social Worker ...... 51 1 51 Patient Care Dialysis Technician ...... 39 1 39

Total ...... 10 1,116

The dialysis facility must also review 494.150(c)(1)) the medical director to implementing regulations of the PRA at and update its emergency preparedness participate in a periodic review of 5 CFR 1320.3(b)(2). policies and procedures at least patient care policies and procedures. Section 494.62(c) will require dialysis annually. We believe that dialysis Thus, we believe compliance with this facilities to develop and maintain an facilities already review their emergency requirement will constitute a usual and emergency preparedness preparedness policies and procedures customary business practice for dialysis communication plan that complied with periodically. In addition, the current facilities and will not be subject to the both federal and state law. The dialysis CfCs already require (at 42 CFR PRA in accordance with the facility must also review and update

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this plan at least annually. The communications in case there is an revise the dialysis facility’s emergency communication plan must include the interruption in phone service to the preparedness communication plan to information listed at § 494.62(c)(1) facility, such as cell phones or text- ensure that it complied with these through (7). messaging devices; and a method for requirements. Based upon our We expect that all dialysis facilities sharing information and medical experience with dialysis facilities, we have some type of emergency documentation with other healthcare anticipate that satisfying these preparedness communication plan. A providers to ensure continuity of care requirements will primarily require the communication plan will be an integral for their patients. However, many involvement of the dialysis facility’s part of any emergency preparedness dialysis facilities may not have formal, administrator, medical director, and plan. Current CfCs already require written emergency preparedness nurse manager. For each dialysis dialysis facilities to have a written communication plans. Therefore, we facility, we estimate that complying disaster plan (42 CFR 494.60(d)(4)). expect that all dialysis facilities will with this requirement will require 4 Thus, each dialysis facility should need to review, update, and in some burden hours at a cost of $513. already have some of the contact cases, develop new sections for their Therefore, for all of the dialysis facilities information they will need to have in plans to ensure that those plans to comply with this requirement will order to comply with this section. In included all of the previously-described require an estimated 26,592 burden addition, we expect that it is standard required elements in their emergency hours (4 burden hours for each dialysis practice in the healthcare industry to preparedness communication plan. facility × 6,648 dialysis facilities) at a have and maintain contact information The burden associated with cost of $3,410,424 ($513 estimated cost for both staff and outside sources of complying with this requirement will be for each dialysis facility × 6,648 dialysis assistance; alternate means of the resources required to review and facilities).

TABLE 125—TOTAL COST ESTIMATE FOR A DIALYSIS FACILITY TO DEVELOP A COMMUNICATION PLAN

Position Hourly wage Burden hours Cost estimate

Administrator ...... $106 2 $212 Medical Director/Physician ...... 207 1 207 Nurse Manager ...... 94 1 94

Total ...... 4 513

Each dialysis facility will also have to that will have to be evaluated and emergency preparedness programs, that review and update its emergency updated at least annually. The dialysis is, the risk assessment, emergency preparedness communication plan at facility will have to comply with the preparedness plan, policies and least annually. For the purpose of requirements located at § 494.62(d)(1) procedures, and communications plans determining the burden for this through (3). that they developed in accordance with requirement, we will expect that Section 494.62(d)(1) will require that § 494.62(a) through (c). Dialysis dialysis facilities will review their dialysis facilities provide initial training facilities will then need to review, emergency preparedness in emergency preparedness policies and revise, and in some cases, develop new communication plans annually. We procedures to all new and existing staff, material for their training programs so believe that all dialysis facilities have an individuals providing services under that they complied with these administrator that will be primarily arrangement, and volunteers, consistent requirements. responsible for the day-to-day operation with their expected roles, and maintain documentation of the training. The burden associated with of the dialysis facility. This will include complying with this requirement will be ensuring that all of the dialysis facility’s Thereafter, the dialysis facility will have to provide emergency preparedness the time and effort necessary to develop policies, procedures, and plans were up- the required training program. We to-date and complied with the relevant training at least annually. Current CfCs already require dialysis expect that complying with this federal, state, and local laws, facilities to provide training and requirement will require the regulations, and ordinances. We expect orientation in emergency preparedness involvement of the administrator, that the administrator will be to the staff (§ 494.60(d)(1)) and provide medical director, and the nurse responsible for periodically reviewing appropriate orientation and training to manager. In fact, the medical director’s the dialysis facility’s plans, policies, patients in emergency preparedness responsibilities include, among other and procedures as part of his or her (§ 494.60(d)(2)). In addition, the dialysis things, staff education and training work responsibilities. Therefore, we facility’s patient instruction will have to (§ 494.150(b)). We estimate that it will expect that complying with this include the same matters that are require 7 burden hours for each dialysis requirement will constitute a usual and specified in the current CfCs (42 CFR facility to develop an emergency customary business practice and will 494.60(d)(2)). Thus, dialysis facilities training program at a cost of $807. not be subject to the PRA in accordance should already have an emergency Therefore, it will require an estimated with the implementing regulations of preparedness training program for new 46,536 burden hours (7 burden hours for the PRA at 5 CFR 1320.3(b)(2). employees, as well as ongoing training each dialysis facility × 6,648 dialysis Section 494.62(d) will require dialysis for all their staff and patients. However, facilities) to comply with this facilities to develop and maintain all dialysis facilities will need to review requirement at a cost of $5,364,936 emergency preparedness training, their current training programs and ($807 estimated cost for each dialysis testing and patient orientation programs compare their contents to their updated facility × 6,648 dialysis facilities).

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TABLE 126—TOTAL COST ESTIMATE FOR A DIALYSIS FACILITY TO DEVELOP A TRAINING PROGRAM

Position Hourly wage Burden hours Cost estimate

Administrator ...... $106 3 $318 Medical Director/Physician ...... 207 1 207 Nurse Manager ...... 94 3 282

Total ...... 7 807

The dialysis facility must also review engaging in a full-scale exercise for 1 facilities should have already been and update its emergency preparedness year following the onset of the actual developing scenarios for testing their training program at least annually. We event. Dialysis facilities will also be plans. Thus, we believe complying with believe that dialysis facilities already required to analyze their responses to this requirement will constitute a usual review their emergency preparedness and maintain document of all drills, and customary business practice and training programs periodically. tabletop exercises, and emergency will not be subject to the PRA in Therefore, we believe compliance with events. To comply with this accordance with the implementing this requirement will constitute a usual requirement, a dialysis facility will need regulations of the PRA at 5 CFR and customary business practice and to develop scenarios for each drill and 1320.3(b)(2). will not be subject to the PRA in exercise. A dialysis facility will also accordance with the implementing have to develop the documentation Section 494.62(d)(3) will require regulations of the PRA at 5 CFR necessary for recording and analyzing dialysis facilities to provide appropriate 1320.3(b)(2). the drills, tabletop exercises, and orientation and training to patients, Section 494.62(d)(2) requires dialysis emergency events. including the areas specified in facilities to participate in a full scale The current CfCs already require § 494.62(d)(1). Section 494.62(d)(1) exercise at least annually. They will also dialysis facilities to evaluate their specifically will require that staff be required to conduct one additional emergency preparedness plan at least demonstrate knowledge of emergency exercise of their choice at least annually (42 CFR 494.60(d)(4)(ii)). Thus, procedures including the emergency annually. If the dialysis facility we expect that all dialysis facilities are information they must give to their experienced an actual natural or man- already conducting some type of tests to patients. Thus, the burden associated made emergency that required evaluate their emergency plans. with this section will already be activation of their emergency plan, the Although the current CfCs do not included in the burden estimate for dialysis facility will be exempt from specify the type of drill or test, dialysis § 494.62(d)(1). TABLE 127—BURDEN HOURS AND COST ESTIMATES FOR ALL 6,648 DIALYSIS FACILITIES TO COMPLY WITH THE ICRS CONTAINED IN § 494.62 CONDITION: EMERGENCY PREPAREDNESS

Burden per Total annual Hourly labor Total labor Regulation section(s) OMB Respondents Responses response burden cost of cost of Total cost Control No. (hours) (hours) reporting ($) reporting ($) ($)

§ 494.62(a)(1) ...... 0938–New ...... 6,648 6,648 12 79,776 ** 8,017,488 8,017,488 § 494.62(a)(2)–(4) ...... 0938–New ...... 6,648 6,648 10 66,480 ** 7,419,168 7,419,168 § 494.62(b) ...... 0938–New ...... 6,648 6,648 10 66,480 ** 7,419,168 7,419,168 § 494.62(c) ...... 0938–New ...... 6,648 6,648 4 26,592 ** 3,410,424 3,410,424 § 494.62(d) ...... 0938–New ...... 6,648 6,648 7 46,536 ** 5,364,936 5,364,936

Totals ...... 6,648 33,240 ...... 285,864 ...... 31,631,184 ** The hourly labor cost is blended between the wages for multiple staffing levels. There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 127.

T. Summary of Information Collection requirements in this final rule will be hours and the costs, for each element of Burden 3,089,505 burden hours at a cost of the requirements in this final rule for Based on the previous analysis, the $279,680,069. Table 127 provides a each provider and supplier type. burden for complying with all of the summary of the ICR burden, for the

VerDate Sep<11>2014 19:01 Sep 15, 2016 Jkt 238001 PO 00000 Frm 00148 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 64007 a a 15a ,52a Costs 30,240 ($) 931 959,7a6 63a,581 1,115,282 1,364,963 9,175,358 9,586, 18,395,175 19,964,1a8 21,324,303 52,467,00a 31,631,184 39,425,899 72,678,6aa Total 279,680,a69 a a 738 8,687 1a,25a 12,672 1a,266 19,227 95,a24 106,75a 285,864 268,191 22a,143 265,858 555,5aa 88a,515 349,82a Total Hours 3,a89,5a5 constitute will WITH a a 7,488 ($) 196,812 129,472 313,664 259,94a 227,476 and Costs 2,439,196 2,111,515 2,64a,6aa 5,364,936 5,a46,44a 4,752,594 4,711,615 Training Exercise 1a,913,5aa 21,191,53a 6a,3a6,778 requirements a a COMPLY these 180 2,87a 2,772 2,61a 4,9a1 2,a23 and 25,854 23,485 68,607 6a,335 65,9a5 46,536 44,a1a with Hours 172,5aa 283,7a5 806,293 Training Exercise TO a a 2,988 9a,828 53,312 compliance 148,a1a 126,126 188,71a 118,50a 142,5a6 1,111,a47 1,541,47a 1,613,a62 1,a56,24a 1,494,295 3,410,424 3, 8,839,10a ($) -Costs 1a, 32,936,618 Thus, Plan Communication SUPPLIERS PREPAREDNESS a a practices. 72 812 833 1,64a 1,584 1,885 AND 12,a33 17,a8a 19,976 13,2a3 13,45a 26,592 78,5aa 37,422 123,35a 348,432 Hours business Plan- Communication normal a a - their EMERGENCY and of 4,212 requirements. 167,895 186,912 1a2,34a 539,a52 249,951 PROVIDERS part '87 1,573,171 1,91a,825 3,58a,698 3,a43,339 4,677,75a 7,419,168 and ($)s Cost 13,a28,oaa 19,538,64a 17,229,364 73,251,317 as Policies Development Procedures of OBRA Implementation RULE: ALL the a a - programs 108 and 1,845 1,428 3,393 4,64a 2,376 FOR 16,178 44,946 21,35a 66,48a 39,197 56,133 1a8,8aa 141,345 222,a3a 73a,249 FINAL and Hours hospital's Policies implementing Procedures Development the of Implementation in THIS a a 11a IN regulations 8,964 Costs involved 188,9a6 293,832 2a7,665 213,962 453,754 ,354,4aa ($) Annual the ESTIMATES Plan 4,679,378 2,558,439 2,312,2a5 4,677,75a 7,419,168 9,325, 9,963,76a 11 14,a82,925 67,74a,218 of and Development usually Review are a a HOUR 216 they 2255 1,624 3,96a 2,737 6,a32 requirements Hours 54,934 83,39a 56,133 25,974 25,62a 66,48a 117,2aa 163,375 117,46a 727,39a Annual Plan CONTAINED PRA hospital, and of Development Review the 0 a of ICRs BURDEN waiver a 6,588 part 69,a2a 156,a24 148,a1a 131,495 for 2a5,a88 ,493,5a5 are ($) 1 1,71a,135 8,332,aaa 8,a17,488 3,81a,422 3,898,819 5,692,a4a 4,a97,7a9 7,676,795 Risk THE practice 45,445,138 Costs Assessment TOTAL provides business '87 transplants a a a 162 58 128: 1,98a 1,64a 1,666 3,a16 14,985 19,215 88,a55 78,5aa 39,952 79,776 51,988 45,73a 49,896 since OBRA 477,141 Risk Hours customary that Assessment and Facilities expect TABLE usual *We **LTC a Centers* Facilities Totals Facilities** Provider/Supplier LTC RNCHis Hospices PRTFs PACE Hospitals HHAs RHCs/FQHCs Dialysis ICF/IIDs CORFs CAHs Organizations CMHCs OPOs Transplant ASCs

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If you comment on these information The directive aims to transform our Based on data from the National collection and recordkeeping national approach to protecting the Oceanic and Atmospheric requirements, please mail copies health of the American people against Administration, the United States directly to the following: Centers for all disasters. experiences an annual average of 56 fatalities as a result of tornadoes (http:// Medicare & Medicaid Services, Office of B. Overall Impact Strategic Operations and Regulatory www.spc.noaa.gov/wcm/ustormaps/ Affairs, Regulations Development We have examined the impacts of this 1981-2010-stateavgfatals.png). On Group, Attn.: William Parham, (CMS– final rule as required by Executive average, floods kill about 140 people 3178–F), Room C4–26–05, 7500 Security Order 12866 on Regulatory Planning each year (United States Department of Boulevard, Baltimore, MD 21244–1850; and Review (September 30, 1993), the Interior, United States Geological and Office of Information and Executive Order 13563 on Improving Survey Fact Sheet ‘‘Flood Hazards—A Regulatory Affairs, Office of Regulation and Regulatory Review National Threat’’ January, 2006, at Management and Budget, Room 10235, (January 18, 2011), the Regulatory http://pubs.usgs.gov/fs/2006/3026/2006- New Executive Office Building, Flexibility Act (RFA) (September 19, 3026.pdf). 1980, Pub. L. 96–354), section 1102(b) of Washington, DC 20503, Attn: CMS Desk 2. Benefits to Patients/Residents Officer, CMS–3178–F, Fax (202) 395– the Social Security Act, section 202 of 6974. the Unfunded Mandates Reform Act of It is commonly understood that 1995 (March 22, 1995 Pub. L. 104–4), healthcare facilities that do not have an IV. Regulatory Impact Analysis and Executive—Order 13132 on emergency plan, develop policies and A. Statement of Need Federalism (August 4, 1999), and the procedures, and train and exercise their Congressional Review Act (5 U.S.C. staff are at a heightened risk for Executive Orders 12866 and 13563 804(2)). healthcare delivery and service direct agencies to assess all costs and Executive Orders 12866 and 13563 disruptions. For instance, patients with benefits of available regulatory directs agencies to assess all costs and ESRD have experienced problems alternatives and, if regulation is benefits of available regulatory accessing care and adverse outcomes necessary, to select regulatory alternatives and, if regulation is during disasters. These patients are approaches that maximize net benefits necessary, to select regulatory particularly at risk for having increased (including potential economic, approaches that maximize net benefits morbidity and mortality following environmental, public health and safety (including potential economic, disasters due to their dependence on effects, distributive impacts, and environmental, public health and safety regular life-maintaining dialysis equity). effects, distributive impacts, and treatments. Hurricane Katrina was In response to past terrorist attacks, equity). A regulatory impact analysis particularly devastating for the dialysis- natural disasters, and the subsequent (RIA) must be prepared for major rules dependent population and led to the national need to refine the nation’s with economically significant effects dialysis community, including facilities, strategy to handle emergency situations, ($100 million or more annually). The recommending more integrated and there continues to be a coordinated total projected cost of this rule will be better emergency planning, training and effort across federal agencies to establish $373 million in the first year, and the exercises in addition to other a foundation for development and subsequent projected annual cost will preparedness recommendations. One expansion of emergency preparedness be approximately $25 million. We example was for dialysis facilities to systems. There are two Presidential solicited and received comments on the implement early dialysis (an early Directives, HSPD–5 and HSPD–21, proposed RIA. As such, we have treatment in advance of the storm’s instructing agencies to coordinate their presented our best estimate of the landfall) for notice weather events, such emergency preparedness activities with impact, including both costs and as hurricanes, snow storms, or other each other. Although these directives do benefits, of this rule. severe weather (Kenney, Robert J. not specifically require Medicare ‘‘Emergency preparedness concepts for 1. Disaster Data providers and suppliers to adopt dialysis facilities: Reawakened after measures, they have set the stage for Published reports after Hurricane Hurricane Katrina.’’ Clinical Journal of what we expect from our providers and Katrina reported that the Louisiana the American Society of Nephrology 2.4 suppliers in regard to their roles in a Attorney General investigated (2007): 809–813 DOI: 10.2215/ more unified emergency preparedness approximately 215 deaths that occurred CJN.03971106). In order to implement system. in hospitals and nursing homes early dialysis, particularly in moderate Homeland Security Presidential following Katrina. (Fink, Sheri to large scale emergencies, facilities Directive (HSPD–5): Management of (September 10, 2013). Five Days at need to have an integrated emergency Domestic Incidents requires the Memorial: Life and Death in a Storm- plan, policies and procedures, training Department of Homeland Security to Ravaged Hospital. New York: Crown and exercises. All of which are needed develop and administer the National Publishers. p. 360. ISBN 978–0–307– to better ensure that staff are able to Incident Management System (NIMS). 71896–9.) Since nearly all hospitals and rapidly activate and operate the facility Homeland Security Presidential nursing homes are certified to emergency plan, prioritize and contact Directive (HSPD–21) addresses public participate in the Medicare program, we patients and transportation, and health and medical preparedness. The estimate that at least a small percentage coordinate a surge in patient care directive establishes a National Strategy of these lives could be saved as a result coordination for both early and their for Public Health and Medical of emergency preparedness measures in regularly scheduled dialysis treatments. Preparedness (Strategy), which builds a single disaster of equal magnitude. Hurricane Sandy was predicted to be upon principles set forth in ‘‘Biodefense Katrina is an extreme example of a a severe storm many days in advance of for the 21st Century’’ (April 2004), natural disaster, so we also considered its actual landfall. State health officials, ‘‘National Strategy for Homeland other more common disasters. The in anticipation of its severity, Security’’ (October 2007), and the United States experiences numerous encouraged dialysis facilities to dialyze ‘‘National Strategy to Combat Weapons natural disasters annually, including, in patients ahead of schedule and rapidly of Mass Destruction’’ (December 2002). particular, tornadoes and flooding. activated the Kidney Community

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Emergency Response (KCER) Coalition have provided the following cost Individuals and states are not included to provide additional assistance for analysis. In order to ‘‘break even’’ on the in the definition of a small entity. Since coordinating notification and cost of this rule, that is, in order for the the cost associated with this final rule transportation services for patients, and total costs of implementing this rule to is less than $46,000 for hospitals and to activate additional staff and resources equal the total benefits of doing so- this $4,000 for other entities, the Secretary to provide treatment at numerous rule would need to save 11.5 lives per has determined that this proposed will facilities. Studies, following Hurricane year for 5 years at a 7 percent discount not have a significant economic impact Sandy, found regional variability in the rate and a value of $9 million per on a substantial number of small receipt of early dialysis amongst the statistical life saved. It would take about entities.’’ nearly 14,000 dialysis study patients. 11 statistical lives saved per year for 5 In addition, section 1102(b) of the Act ASPR and CMS, using Medicare claims years at a 3 percent discount rate for this requires us to prepare a regulatory data, conducted the two studies to final rule to break even. Therefore, we impact analysis if a rule may have a assess the impact of Hurricane Sandy on believe it is crucial for all providers and significant impact on the operations of end-stage renal disease patients that suppliers to have an emergency disaster a substantial number of small rural require regular dialysis and to assess plan that is integrated with other local, hospitals. This analysis must conform to early dialysis treatment patterns and state and federal agencies to effectively the provisions of section 604 of the outcomes for those receiving it in the address both natural and manmade RFA. For purposes of section 1102(b) of impacted areas. The first study disasters. the Act, we define a small rural hospital identified a significant increase in the We believe that this final rule will be as a hospital that is located outside of number of emergency department visits, an economically significant regulatory a metropolitan statistical area and has hospitalizations, and patient death 30 action under section 3(f)(1) of Executive fewer than 100 beds. Since the cost days following the disaster and regional Order 12866, since it may lead to associated with this final rule is less variability in patients receiving early impacts of greater than $100 million in than $46,000 for hospitals, this this dialysis prior to Hurricane Sandy’s the first year following the rule’s proposed will not have a significant landfall. The second study found that effective date. impact on the operations of a substantial This final rule will establish a the 60 percent of study patients that number of small rural hospitals. received early dialysis were found to regulatory framework with which have 20 percent lower odds of having an Medicare- and Medicaid-participating 4. Unfunded Mandates Reform Act emergency department visit, 21 percent providers and suppliers will have to comply to ensure that the varied Section 202 of the Unfunded lower odds of a hospitalization in the Mandates Reform Act of 1995 (UMRA) week of the storm, and 28 percent lower providers and suppliers of healthcare are adequately prepared to respond to requires that agencies assess anticipated odds of death 30 days after the storm. natural and man-made disasters. costs and benefits before issuing any (Kelman J., Finne K., Bogdanov A., rule that includes a federal mandate that Worrall C., Margolis G., Rising K., 3. The Regulatory Flexibility Act (RFA) could result in expenditure in any 1 MaCurdy T.E., Lurie N. Dialysis care The Regulatory Flexibility Act (RFA) year by state, local or tribal and death following Hurricane Sandy. (5 U.S.C. 601 et seq.) (RFA) requires governments, in the aggregate, or by the Am J Kidney Dis. 2015 Jan; 65(1):109– agencies that issue a regulation to private sector, of $100 million in 1995 15. doi: 10.1053/j.ajkd.2014.07.005. analyze options for regulatory relief of dollars, updated annually for inflation. Epub 2014 Aug 22. PubMed PMID: small businesses if a rule has a In 2016, that threshold level is 25156306. and Lurie, N., Finne, K., significant impact on a substantial approximately $146 million. This Worrall, C., Jauregui, M., Thaweethai, number of small entities. The Act omnibus final rule contains mandates T., Margolis, G., & Kelman, J. (2015). defines a ‘‘small entity’’ as: (1) A that will impose a one-time cost of Early dialysis and adverse outcomes proprietary firm meeting the size approximately $373 million. Thus, we after Hurricane Sandy. Am J Kidney standards of the Small Business have assessed the various costs and Dis., 66(3), 507–512. Administration (SBA); (2) a not-for- benefits of this final rule. It is clear that Although we are unable to profit organization that is not dominant a number of providers and suppliers specifically quantify the number of lives in its field; or (3) a small government will be affected by the implementation saved as a result of this final rule, all of jurisdiction with a population of less of this final rule and that a substantial the data we have reviewed regarding than 50,000. States and individuals are number of those entities will be emergency preparedness indicate that not included in the definition of ‘‘small required to make changes in their implementing the requirements in this entity.’’) HHS uses as its measure of operations. This final rule will not final rule could have a significant significant economic impact on a mandate any new requirements for state, impact on protecting the health and substantial number of small entities a local or tribal governments. For the safety of individuals served by change in revenues of more than 3 to 5 private sector facilities, this regulatory providers and suppliers that participate percent. impact section constitutes the analysis in the Medicare and Medicaid programs. The RFA requires agencies to analyze required under UMRA. The following cost analysis is based on options for regulatory relief of small 5. Federalism ‘‘Guidelines for Regulatory Impact entities, if a rule has a significant impact Analysis’’ (Robinson, L.A. and J.K. on a substantial number of small Executive Order 13132 establishes Hammitt. 2015, ‘‘Valuing Reductions in entities. For purposes of the RFA, we certain requirements that an agency Risks of Fatal Illness: Implications of estimate that most hospitals and most must meet when it develops a final rule Recent Research.’’ Health Economics. other providers and suppliers are small (and subsequent final rule) that imposes 25(8): 1039–1052) developed by Harvard entities, either by nonprofit status or by substantial direct requirement costs on University for the Assistant Secretary having revenues of less than $11 million state and local governments, preempts for Planning and Evaluation (ASPE). to $38.5 million in any 1 year. For state law, or otherwise has Federalism The Guidelines are not yet public, purposes of the RFA, a majority of implications. This final rule will not however based on the research that was hospitals are considered small entities impose substantial direct requirement published in Health Economics, we due to their non-profit status. costs on state or local governments,

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preempt state law, or otherwise food, water, and supplies, alternate proposed that hospitals test their implicate federalism. sources of energy to provide electrical emergency and stand-by-power systems power, and the maintenance of for a minimum of 4 continuous hours 6. Congressional Review Act temperatures for the safe and sanitary every 12 months at 100 percent of the This final rule is subject to the storage of such provisions as a routine power load the hospital anticipates it Congressional Review Act provisions of measure to ensure against weather will require during an emergency. We the Small Business Regulatory related and non-disaster power failures. received the following public Enforcement Fairness Act of 1996 (5 Thus, we believe that this requirement comment(s) on this requirement: U.S.C. 801 et seq.) and has been is a usual and customary business Comment: We received a large transmitted to the Congress and the practice for inpatient providers and we number of comments from individual Comptroller General for review. have not assigned any impact for this hospitals as well as national and state organizations that expressed concern C. Anticipated Effects on Providers and requirement. Furthermore, we expect that most with the proposed requirement for Suppliers: General Provisions providers have agreements with their hospitals, CAHs and LTC facilities to This final rule will require each of the vendors to receive supplies within 24 to test their generators. Several Medicare- and Medicaid-participating 48 hours in the event of an emergency, commenters stated that there was not providers and suppliers discussed in as well as arrangements with back-up enough empirical data to support the previous sections to perform a risk vendors in the event that the disaster proposed additional financial burden. analysis; establish an emergency affects the primary vendor. We Furthermore, they stated that there is no preparedness plan, emergency considered proposing a requirement that evidence that additional annual testing preparedness policies and procedures, providers must keep a larger quantity of would result in more reliable generators and an emergency preparedness food and water on hand in the event of and that their current testing schedule is communication plan; train staff in a disaster. However, we believe that a sufficient. Several commenters stated emergency preparedness, and test the provider should have the flexibility to that mandating additional testing would emergency plan. The economic impact determine what is adequate based on further burden already strained budgets will differ between hospitals and the the location and individual and that the additional testing would various other providers and suppliers, characteristics of the facility. While cause unnecessary wear and tear on the depending upon a variety of factors, some providers may have the storage equipment. including existing regulatory capacity to stockpile supplies that will Response: We appreciate the requirements and accreditation last for a longer duration, other may not. commenters concerns on this issue. As standards. Thus, we believe that to require such we discussed previously in the We discuss the economic impact for stockpiling will create an unnecessary preamble of this final rule, the purpose each provider and supplier type economic impact on some healthcare of the proposed change in the testing included in this final rule in the order providers. requirement was to minimize the issue in which they appear in the CFR. Most We expect that when inpatient of inoperative equipment in the event of of the economic impact of this final rule providers determine their supply needs, a major disaster, such as what happened will be due to the cost for providers and they will consider the possibility that during the Sandy Super Storm. After suppliers to comply with the volunteers, visitors, and individuals carefully reviewing subsequent reports information collection requirements. from the community may arrive at the on the Sandy Super Storm (for example, Thus, we discuss most of the economic facility to offer assistance or seek the September, 2014 report of the Office impact under the Collection of shelter. of Inspector General (OIG) entitled, Information Requirements section of Based on the previous factors, we ‘‘Hospital Emergency Preparedness and this final rule. We provide a chart at the have not estimated a cost for a stockpile Response During Super Storm Sandy; end of the RIA section of the total of food and water. and the American Society for Healthcare Engineering (ASHE)), and the comments regulatory impact for each provider or 2. Generator Location and Testing supplier. received on the proposed requirement, As stated in the ICR section of this We proposed to require hospitals, we believe that we do not have final rule, we obtained all salary CAHs, and LTC facilities to test and sufficient data to make the assumption information from the May 2014 National maintain their emergency and standby that additional testing would ensure Occupational Employment and Wage power systems in such a way to ensure that the generators would withstand all Estimates, United States by the Bureau proper operation in the event they are disasters, regardless of the amount of of Labor Statistics (BLS) at http:// needed. The 2012 edition of the Life testing conducted prior to an actual ® www.bls.gov/oes/current/oes_nat.htm Safety Code (LSC) of the NFPA states disaster. Therefore, we have decided and calculated the added value of 100 that the alternate source of power (for against finalizing the proposed percent for overhead and fringe benefits. example, generator) must be located in requirement for additional generator an appropriate area to minimize the testing at this time. We expect facilities 1. Subsistence Requirement possible damage resulting from disasters that have generators to continue to test This final rule will require all such as storms, floods, earthquakes, their equipment based on current inpatient providers to meet the tornadoes, hurricanes, vandalism, NFPA® codes (NFPA® 99 and NFPA® subsistence needs of staff and patients, sabotage and other material and 110 and NFPA® 101) and manufacturer whether they evacuate or shelter in equipment failures. Since hospitals, requirements. place, including, but not limited to, CAHs and LTC facilities are currently food, water, and supplies, alternate required to comply with the referenced 3. Purchase of Communication Devices sources of energy to maintain LSC; we have not assigned any We are finalizing our proposal to temperatures to protect patient health additional burden for this requirement. require providers and suppliers to and safety and for the safe and sanitary In addition to the emergency power develop and maintain a communication storage of such provisions. system inspection and testing plan that includes the contact Based on our experience, we expect requirements found in NFPA® 99 and information for and a means for inpatient providers to currently have NFPA® 110 and NFPA® 101, we communicating with staff, federal, state,

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tribal, regional, and local emergency need to purchase communication used to locate sample plans, tools, management entities. It is crucial for devices to comply with the templates, and training and exercise providers and suppliers to be aware of requirements of the final rule. materials. TRACIE also provides access who to contact during an emergency to expert technical assistance and an 4. Use of Outside Consultants situation and for them to have a means information-sharing exchange platform for communicating with the appropriate We recognize that some of the to assist the exchange of best practices, emergency management officials during provider and supplier types impacted vetted tools, and information between an emergency or disaster. While we did by this final rule have more experience public health, healthcare professionals, not propose a specific mechanism for in the area of emergency preparedness and many other emergency purposes of communicating during an than others. In particular, those provider preparedness partners. TRACIE’s emergency, we recognize the possibility and supplier types without existing technical assistance specialists can be that some providers and suppliers may emergency preparedness related reached Monday through Friday, 9 a.m. need to purchase communication requirements may find it useful to seek to 5 p.m. Eastern Standard Time, at 1– devices to meet the requirements of this resources and guidance from outside 844–5–TRACIE or by email at final rule. consultants for purposes of complying [email protected]. We anticipate that most providers and with the requirements of this final rule. Providers and suppliers may also suppliers maintain updated information We note that we have not required access the Centers for Disease Control for staff as well as state and local providers and suppliers to hire outside and Prevention (CDC) Web site found at officials as part of their typical business consultants to develop their emergency http://www.cdc.gov/phpr/healthcare/ operations. We also expect that as a best preparedness programs, and we do not planning.html) for various tools and practice, many providers and suppliers believe it will be necessary in most resources. In addition, there are many already utilize some type of cases based on the free resources and tools and free online training sessions communication system or device for information available to providers. related to emergency preparedness that purposes of communicating with their Furthermore, in advance of hiring are offered through FEMA’s Emergency staff, physicians, volunteers, and other outside consultants, we encourage Management Institute (EMI) Web site providers and suppliers during providers and suppliers to look to their found at https://training.fema.gov/ emergency situations. We want to local public health, emergency emi.aspx. reiterate that in addition to cellular management agencies and local Lastly, while we recognize that some phones, alternate communication healthcare coalitions for assistance and providers may choose to seek some devices may also include but are not guidance. Therefore, for purposes of the outside consulting assistance, we note limited to pagers, radio transceivers, RIA we have not included a cost that it is important that providers and various radio devices such as the associated with the activity of hiring suppliers develop their own plans to National Oceanic and Atmospheric outside consultants, as we are unable to ensure that they truly understand their Administration’s Weather Radio All quantify with any degree of certainty the capabilities and can readily activate and Hazards, and Portable interconnected number of providers that may choose to implement their emergency and Voice over Internet Protocol (VoIP) use outside resources or the cost of such communication plans in the event of an services. resources. emergency. Additional resources that For purposes of the RIA, we assume There are nearly 500 healthcare can support provider and supplier that, at a minimum, those providers and coalitions nationwide that providers preparedness are below: suppliers without existing emergency and suppliers may seek to participate in, • HHS Response and Recovery preparedness requirements are mostly which currently include more than Resources Compendium (http:// likely to be presented with the need to 24,000 healthcare facilities and www.phe.gov/emergency/ purchase communication devices to community partners. In addition, hhscapabilities/Pages/default.aspx): comply with the requirements of the providers and suppliers should leverage HHS Response and Recovery Resources communication plan in this final rule. resources through their memberships Compendium offers an easy-to-navigate, Those provider and supplier types with professional associations and non- comprehensive, web-based repository of without any existing emergency government agencies, such as the Red HHS resources and capabilities preparedness requirements are CMHCs, Cross. Many non-government available to federal, state, tribal, OPOs, PRTFs, and outpatient hospices. organizations and both national and territorial, and local agencies before, As stated previously, this final rule will local professional associations provide during, and after public health and impact 17 different provider and vetted emergency preparedness medical incidents. The compendium supplier types. When taking into resources, materials and trainings. spans 24 topics, including situational consideration all 17 provider and These organizations and healthcare awareness and mass care and emergency supplier types, this rule will have a coalitions also commonly conduct and assistance, and contains a list of the combined impact on 72,315 entities support community-based exercises and major HHS capabilities, products and (sum of the total number of provider encourage participation from other services that support that each topic and and supplier entities). Those providers providers in their localities. information on accessing them. and supplier types without emergency In addition, we note that there are • DisasterLit (https:// preparedness requirements represent 6 several readily accessible, free, and disasterlit.nlm.nih.gov/): DisasterLit is a percent of this total (4,622 total entities expert-vetted, emergency preparedness database of disaster medicine and without existing emergency resources that are available to providers public health resources selected from preparedness related requirements (198 and suppliers from government entities. over 700 organizations available at no CMHCs + 58 OPOs + 377 PRTFs + 3,989 First, providers and suppliers may cost. These resources include outpatient hospices)/72,315 (sum of the access HHS’ Office of the Assistant guidelines, government and other total number of entities impacted by this Secretary for Preparedness and technical documents, plans, videos, and regulation)). Therefore, we anticipate Response (ASPR) Technical Resources training classes. that, at a minimum 6 percent of the Assistance Center Information Exchange • Public Service Announcements for providers and suppliers impacted by (TRACIE) found at https:// Disasters: Public Service this final rule will have the potential asprtracie.hhs.gov/. TRACIE can be Announcements (PSAs) provide a wide

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variety of announcements on common choice at least annually. ASCs also will the registered nurse will most likely issues in disaster preparedness, be required to maintain documentation represent the IDG during the testing response and recovery. They can be of the exercise. exercises. While we expect that all staff used to help health communicators State, Tribal, Territorial, and local will be involved in the testing exercises, provide timely messages about what public health and medical systems we will consider their involvement as people can do to protect themselves, comprise a critical infrastructure that is part of their regular staff training. their families and their communities integral to providing the early However, for the purpose of this during disasters and emergencies. They recognition and response necessary for analysis we assume that the are available in a wide variety of minimizing the effects of catastrophic administrator will spend approximately formats, including tweets, vines, public health and medical emergencies. 4 hours annually to participate in a full- podcasts, YouTube videos, broadcast Educating and training these clinical, scale exercise and one additional testing scripts, and broadcast videos. laboratory, and public health exercise of the facility’s choice outside professionals has been, and continues to of their regular and ongoing training. D. Condition of Participation: be, a top priority for the federal We also assume that the registered nurse Emergency Preparedness for Religious Government. There are currently three will spend 4 hours to participate in the Nonmedical Health Care Institutions programs at HHS addressing education testing exercises. Thus, we estimate that (RNHCIs) and training in the area of public health each hospice will spend $560. The total 1. Training and Testing (§ 403.748(d)) emergency preparedness and response: estimate for all hospices to comply with The Centers for Public Health this requirement after the initial year We discuss the majority of the Preparedness (CPHP), the Bioterrorism will total $2,464,560 ($560 × 4,401 economic impact for this requirement in Training and Curriculum Development hospices). We estimate the total the ICR section, which is estimated at Program (BTCDP), and National economic impact and cost estimates for $30,240. Laboratory Training Network (NLTN). all 4,401 hospices to comply with the 2. Testing (§ 403.748(d)(2)) As discussed earlier in this preamble, requirements in this final rule for the ASCs can use these and other resources, initial year will be $22,428,668 Section 403.748(d)(2) will require such as tools offered by the Department ($2,464,560 impact cost + $19,964,108 RNHCIs to conduct a paper-based, of Homeland Security, to assist them in ICR burden). tabletop exercise at least annually. complying with this proposed RNHCIs must analyze their response requirement. Thus, we believe that the G. Emergency Preparedness for and maintain documentation of all cost associated with this requirement Psychiatric Residential Treatment tabletop exercises, and emergency will be limited to the staff time to Facilities (PRTFs)—Training and events, and revise their emergency plan participate in the community-wide and Testing (§ 441.184(d)) as needed. facility-wide trainings, and testing Section 441.184(d)(2)(i) through (iii) We expect that the cost associated exercises. We believe that appreciable will require PRTFs to participate in a with this requirement will be limited to staff time will be required of the full-scale exercise and one additional the staff time needed to participate in administrator and a registered nurse. We exercise of their choice annually. We the tabletop exercises. We estimate that believe that other staff members will be estimate that the cost associated with approximately 4 hours of staff time will required to spend a minimal amount of this requirement is the time that it will be required of the administrator and time during these exercises and the take key personnel to participate in the director of nursing, and 2 hours of staff training will be considered as part of testing exercises. Furthermore, we time for the head of maintenance to regular on-going training for ASC staff. estimate that the testing exercises will coordinate facility evacuations and We estimate that the administrator and involve the administrator and registered protocols for transporting residents to a registered nurse will spend about 4 nurse to spend about 4 hours each on alternate sites. We believe that other hours each on an annual basis to an annual basis to participate. Thus, we staff members will be required to spend participate in the testing exercises. anticipate that complying with this a minimal amount of time during these Thus, we anticipate that complying with requirement will require 4 hours for the exercises and such staff time will be this requirement will require 8 hours for administrator (at a salary of $93 an considered a part of regular on-going an estimated cost of $724 for each of the hour) and 4 hours for the registered training for RNHCI staff. We estimate 5,485 ASCs and a total cost estimate of nurse (salary $64 an hour) at a that it will require 10 hours of staff time $3,971,140 for all ASCs ($724 × 5,485 combined estimated cost of $628 per for each of the 18 RNHCIs to conduct ASCs) each year after the first year. We facility. The total annual cost for all 377 exercises at a cost of $476. Therefore, it estimate total costs for ASCs of PRTFs will be $236,756. The total cost will require an estimated total impact of $22,366,315 ($3,971,140 impact cost + for the first year to comply with the $8,568 each year after the initial year for $18,395,175ICR burden) in the first year requirement will be $1,471,431 all RNHCIs to comply with of compliance, and $3,971,140, per year ($236,756 impact cost + $1,234,675 ICR § 403.748(d)(2). For the initial year, we in subsequent years. burden). estimate $38,808 as the total economic impact and cost estimates for all 18 F. Condition of Participation: H. Emergency Preparedness for Program RNHCIs to comply with the Emergency Preparedness for Hospices— for the All-Inclusive Care for the Elderly requirements in this final rule. Testing (§ 418.113(d)(2)) (PACE) Organizations—Training and Section 418.113(d)(2)(i) through (iii) Testing (§ 460.84(d)) E. Condition for Coverage: Emergency will require hospices to participate in Section 460.84(d)(2)(i) through (iii) Preparedness for Ambulatory Surgical testing exercises at least annually. We will require PACE organizations to Centers (ASCs)—Testing (§ 416.54(d)(2)) believe that the administrator will be conduct a full-scale exercise and one Section 416.54(d)(2) will require responsible for participating in additional testing exercise of their ASCs to participate in a full-scale community-wide disaster drills and will choice annually. Since PACE exercise at least annually. ASCs also be the primary person to organize any organizations are currently required to will be required to conduct one testing exercises with the assistance of conduct a facility-wide drill annually, additional testing exercise of their one member of the IDG. We believe that we are only estimating economic impact

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for the additional testing exercise. We maintained in-hospital for immediate and appropriately revise, update, or expect that both the home-care needs. The Federal Metropolitan develop new sections and new material coordinator and the quality- Medical Response System (MMRS) for their training program. The improvement nurse will each spend 1 guidelines call for MMRS communities economic impact associated with this hour to conduct the exercise. Thus, we to be self-sufficient for 48 hours. We requirement is the staff time required for estimate the economic impact hours to encourage hospitals to work with non-TJC accredited hospitals to review, be 2 hours for each PACE organization stakeholders (state boards of pharmacy, update or develop a training program. at an estimated cost of $128 for each pharmacy organizations, and public We discuss the economic impact for this organization. The total annual cost for health organizations) for guidance and requirement in the ICR section. all PACE organizations is $15,232 ($128 assistance in identifying medications 3. Testing (§ 482.15(d)(2)(i) Through × 119 providers). The total cost for all they may need. Based on our experience (iii)) PACE organizations to comply with the with hospitals, we believe that they will requirements in the first year will be have on hand a 2 to 3 day supply of Section 482.15(d)(2)(i) through (iii) $645,904 ($15,323 impact cost + medical supplies at the onset of a will require hospitals to participate in or $630,581 ICR burden). disaster. In the event of a prolonged conduct a full-scale exercise and one emergency response, additional additional testing exercise of their I. Condition of Participation: Emergency resources may be requested from state choice at least annually. State, tribal, Preparedness for Hospitals and federal agencies. CDC’s Strategic territorial, and local public health and 1. Medical Supplies (§ 482.15(b)(1)) National Stockpile (SNS), for example, medical systems comprise a critical has large quantities of medicine and infrastructure that is integral in We proposed that hospitals must medical supplies for a public health maintain medical supplies. This providing early recognition and emergency that is severe enough to response necessary for minimizing the regulation does not require sufficient cause local supplies to run out and can supplies for a certain time frame, but effects of catastrophic public health and deliver them to any state in the U.S. in medical emergencies. Educating and other organizations do suggest time for them to be effective. Each state standards. The American Hospital training these clinical, laboratory, and has plans to receive and distribute SNS public health professionals has been, Association (AHA) recommends that medicine and medical supplies to local individual hospitals have a 24-hour and continues to be, a top priority for communities as quickly as possible. the federal government. There are supply of pharmaceuticals and that they (http://www.cdc.gov/phpr/stockpile/ develop a list of required medical and currently three programs at HHS stockpile.html). addressing education and training in the surgical equipment and supplies. TJC Additional information regarding standards require a hospital to have a 48 area of public health emergency HHS’ core capabilities to support public preparedness and response. The to 72 hour stockpile of medication and health and medical responses can be supplies. programs are the Centers for Public found in 2015 FEMA National Response Health Preparedness (CPHP), The The Department of Homeland Framework (see: http://www.fema.gov/ Bioterrorism Training and Curriculum Security (DHS) Act of 2002 established national-response-framework) and more Development Program (BTCDP), and the Strategic National Stockpile (SNS) specifically within the Emergency National Laboratory Training Network Program to work with governmental and Support Function #8 Public Health and (NLTN). Hospitals can use these and non-governmental partners to upgrade Medical Annex that is located at http:// other resources, such as tools offered by the nation’s public health capacity to www.fema.gov/media-library-data/ the DHS, to assist them in complying respond to a national emergency. The 20130726-1914-25045-5673/final_esf_8_ with this requirement. Thus, for non- SNS is a national repository of public_health_medical_20130501.pdf. TJC accredited hospitals, the costs antibiotics, chemical antidotes, Therefore, based on the previous associated with this requirement will be antitoxins, life-support medications and information, we are not assessing medical supplies. additional burden for medical supplies. primarily due to the staff time needed The SNS, and other federal agencies, to participate in the testing exercises. http://emergency.cdc.gov/stockpile/ 2. Training Program (§ 482.15(d)(1)) We believe that appreciable staff time index.asp, have plans to address the Section 482.15(d)(1) will require will be required of the risk management medical needs of an affected population hospitals to develop and maintain an director, facilities director, safety in the event of a disaster. The SNS has emergency preparedness training director, and security manager. We large quantities of medicine and program and review and update it at expect that other staff members will be medical supplies to protect the least annually. Based on our experience required to spend a minimal amount of American public if there is a public with healthcare facilities, we expect that time during these exercises, which will health emergency (for example, a all healthcare facilities provide some be considered a part of regular on-going terrorist attack, flu outbreak, or type of training to all personnel, training for hospital staff. We estimate earthquake) severe enough to cause including those providing services that the risk management director, local supplies to run out. After federal under contract or arrangement and facilities director, safety director and and local authorities agree that the SNS volunteers. Since such training is security manager will spend about 12 is needed, medicines can be delivered to required for the TJC-accredited hours each on an annual basis to meet any state in the U.S. within 12 hours. hospitals, the proposed requirements for the proposed requirement. Each state has plans to receive and developing an emergency preparedness- Thus, we have estimated the distribute SNS medicine and medical training program and the materials they economic impact for the 1,345 non-TJC supplies to local communities as plan to use in providing initial and on- accredited hospitals. We anticipate that quickly as possible. States have the going annual training will constitute a complying with this requirement will discretion to decide where to distribute usual and customary business practice require 48 hours for an estimate of the supplies in the event of multiple for TJC-accredited hospitals. $4,992 for each non TJC-accredited events. However, under this final rule, non hospital. Therefore, it will cost all non However, prudent emergency TJC-accredited hospitals will need to TJC-accredited hospitals an estimated planning requires that some supplies be review their existing training program total cost of $6,714,240 ($4,992 per non

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TJC-accredited hospital × 1,345 Pharmacy, pharmacy organizations, and M. Condition of Participation: hospitals = $6,714,240). public health organizations) for Emergency Preparedness for Home Based on TJC’s standards, the TJC- guidance and assistance in identifying Health Agencies (HHAs)—Training and accredited hospitals are currently medications that may be needed and Testing (§ 484.22(d)) required to test their emergency plan to provide access to all healthcare We discuss the majority of the operations plan twice a year. Therefore, partners during an event. economic impact for this requirement in for TJC-accredited hospitals to conduct 2. Training and Testing (§ 483.73(d)) the COI section which is estimated to be testing exercises will constitute a usual $72,678,600. and customary business practice and we Section 483.73(d)(2)(i) through (iii) Section 484.22(d)(2)(i) through (iii) will not include this activity in the will require LTC facilities to participate will require HHAs to participate in a economic impact analysis. We have in or conduct a full-scale exercise and full-scale exercise and one additional estimated that the total economic one additional testing exercise of their testing exercise of their choice at least impact of this final rule on hospitals choice at least annually. The current annually. We also require the HHA to will be $46,140,139 ($6,714,240 testing requirements for LTC facilities already maintain documentation of the testing exercises impact cost + $39,425,899 ICR mandate that these facilities exercises. burden). periodically review their procedures There are currently three programs at J. Condition of Participation: Emergency with existing staff, and carry out HHS addressing education and training Preparedness for Transplant Centers unannounced staff drills in the area of public health emergency (§ 483.75(m)(2)). Thus, we expect that preparedness and response: The Centers There is no additional economic complying with the requirement for for Public Health Preparedness (CPHP), impact to discuss in this section for annual testing of their emergency plan the Bioterrorism Training and transplant centers. All transplant will constitute a minimal economic Curriculum Development Program centers are located within a hospital impact, if any. (BTCDP), and National Laboratory and, thus, will not have to stockpile Therefore, the cost of this final rule Training Network (NLTN). HHAs can supplies in an emergency or conduct for all LTC Facilities will be limited to use these and other resources, such as testing exercises. the ICR burden of $68,808,717 as tools offered by the Department of K. Emergency Preparedness for Long discussed in the COI section. Homeland Security, to assist them in complying with this requirement. HHS’ Term Care (LTC) Facilities (§ 483.73(b) L. Condition of Participation: Office of the Assistant Secretary for Emergency Preparedness for 1. Subsistence (§ 483.73(b)(1)) Preparedness and Response (ASPR) and Intermediate Care Facilities for HHS’s Centers for Disease Control and Section 483.73(b)(1) will require LTC Individuals With Intellectual Disabilities Prevention (CDC) also provides facilities to provide subsistence needs (ICFs/IID)—Testing (§ 483.475(d)(2)) for staff and residents, whether they numerous tools and resources on their evacuate or shelter in place, including, Section 483.475(d)(2)(i) through (iii) Web site (see http://www.cdc.gov/phpr/ but not limited to, food, water, and will require ICFs/IID to participate in or healthcare/planning.html) in addition medical supplies alternate sources of conduct a full scale exercise and one to the many tools and free online energy for the provision of electrical additional testing exercise of their training sessions that are offered on power, and maintenance of choice at least annually. The current FEMA’s Emergency Management temperatures for the safe and sanitary ICF/IID CoPs require them to conduct Institute (EMI) Web site (https:// storage of such provisions. evacuation drills at least quarterly for training.fema.gov/emi.aspx). Thus, we As stated earlier in this section, each each shift and under varied conditions believe that the cost associated with this state has plans to receive and distribute to evaluate the effectiveness of requirement will be limited to the staff SNS medicine and medical supplies to emergency and disaster plans and time to participate in the community- local communities as quickly as procedures (§ 483.470(i) and (i)(iii)). In wide and facility-wide trainings, and possible. The federal responsibility addition, ICFs/IID must evacuate clients testing exercises. We believe that ceases at the delivery of the push-packs during at least one drill each year on appreciable staff time will be required of to state-designated airports. It is then each shift, file a report and evaluation the administrator and director of the responsibility of the state to break on each evacuation drill and investigate training. We believe that other staff down and transport the components of all problems with evacuation drills, members will be required to spend a the push-pack to the affected including accidents, and take corrective minimal amount of time during these community. It is also at the state’s action (§ 483.470(i)(2)). Since all 6,237 exercises and the training will be discretion where to deliver push-pack ICFs/IID already conduct quarterly considered as part of regular on-going material in the event of multiple events. drills, we estimate a small additional training for HHA staff. We estimate that We expect that a 1- to 2-day supply burden to cover the added complexities the administrator will spend about 2 will be sufficient because various of the rule. Specifically, the rule would hours to participate in the testing national agencies with stockpiles of require the administrator and the exercises. We also estimate that the medicine, medical supplies, food and registered nurse each to spend an director of training will spend a total of water can be mobilized within 12 hours additional hour to participate in testing 3 hours on an annual basis to participate and supplies can be replenished or programs for their facility. Thus, we in the testing exercises. All TJC provided within 48 hours. Thus, for the estimate that the additional cost for each accredited HHAs are required annually sake of this impact analysis, we assume ICF/IID to comply with this requirement to test their emergency management that, at a minimum, a LTC facility will would be $157 for each facility. The program by conducting drills and have a 2-day supply of food and potable total estimate for all facilities to comply documenting their results. Thus, we water for the patients and staff at the with this requirement is $979,209 ($157 anticipate that only non-TJC accredited onset of a disaster and will not assign × 6,237 facilities = $979,209). We HHAs will need to comply with this a cost to this requirement. estimate the total cost will be requirement. We anticipate that it will We encourage LTC facilities to work $22,303,512 ($21,324,303 ICR burden + require 5 hours for each of the 8,005 with stakeholders (State Boards of $979,209 impact cost). non-JC-accredited HHAs, with an

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estimated cost of $2,945,840. Therefore, training for hospital staff. We estimate this requirement will require 8 hours for the total economic impact of this rule on that the administrator (for 7 hours), each CMHC at an estimated cost of $683 HHAs will be $75,624,440 ($2,945,840 facilities director (for 6 hours), and the for each facility. The economic impact impact cost + $72,678,600 ICR burden). director of nursing (for 7 hours) will for all 198 CMHCs will be 135,234 ($683 spend approximately a total of 20 hours × 198 CMHCs). Therefore, the total N. Conditions of Participation: on an annual basis to participate in the Comprehensive Outpatient economic impact of this final rule on testing exercises. Thus, we anticipate Rehabilitation Facilities (CORFs)— CMHCs will be $1,094,940 ($135,234 that complying with this requirement Training and Testing (§ 485.68(d)(2)(i) impact cost + $959,706 ICR burden). will require 20 hours for an estimated Through (iii)) cost of $1,856 for each of the 892 non- R. Conditions of Participation: Section 485.68(d)(2)(i) through (iii) accredited CAHs. Therefore, for all non- Emergency Preparedness for Organ will require CORFs to participate in or accredited CAHs to comply with this Procurement Organizations (OPOs)— conduct a full-scale exercise and one requirement, it will require 17,800 total Training and Testing (§ 486.360(d)(2)(i) additional exercise of their choice at economic impact hours (20 economic Through (iii)) least annually and document the testing × impact hours per non-accredited CAH The OPO CfCs do not currently exercises. To comply with this 892 non-accredited CAH) at an contain a requirement for OPOs to requirement, a CORF will need to estimated total cost of $1,655,552 conduct testing exercises. We estimate develop a specific scenario for each × ($1,856 892). Therefore, the total that these tasks will require the quality exercise. economic impact of this rule on CAHs assessment and performance The current CoPs require CORFs to will be $10,830,910 ($1,655,552 testing provide ongoing drills for all personnel improvement (QAPI) director and the exercises impact cost + $9,175,358 ICR education coordinator to each spend 1 associated with the facility in all aspects burden). of disaster preparedness (§ 485.64(b)(1)). hour to participate in the testing Thus, for the purpose of this analysis, P. Condition of Participation: exercises. Thus, the total annual we believe that CORFs will incur Emergency Preparedness for Clinics, economic impact hours for each OPO minimal or no additional cost to comply Rehabilitation Agencies, and Public will be 2 hours. The total cost will be with this requirement. Thus, we Health Agencies as Providers of $188 for a (QAPI coordinator hourly estimate the cost for all 205 CORFs to Outpatient Physical Therapy and salary and the Education Coordinator to comply with this requirement will be Speech-Language Pathology participate). The economic impact for × limited to the ICR burden of $931,520 (‘‘Organizations’’)—Testing all OPOs will be 188 (2 impact hours discussed in the COI section. (§ 485.727(d)(2)(i) Through (iii)) 58 OPOs) total economic impact hours × Current CoPs require these at an estimated cost of $10,904 (188 O. Condition of Participation: 58 OPOs). Therefore, the total economic Emergency Preparedness for Critical organizations to ensure that employees are trained in all aspects of impact of this rule on OPOs will be Access Hospitals (CAHs) Training and $1,126,186 ($10,904 impact cost + Testing (§ 485.625(d)(2)) preparedness for any disaster. They are also required to have ongoing drills and $1,115,282 ICR burden). Section 485.625(d)(2)(i) through (iii) exercises to test their disaster plan. S. Emergency Preparedness: Conditions will require CAHs to conduct two Rehabilitation Agencies will need to for Certification for Rural Health Clinics annual testing exercises. Accredited review their current activities and make (RHCs) and Conditions for Coverage for CAHs are currently required to conduct minor adjustment to ensure that they Federally Qualified Health Clinics such drills and exercises (See COI comply with the new requirement. (FQHCs) section for detailed discussion regarding Therefore, we expect that the economic our review of accrediting organizations). impact to comply with this requirement 1. Training and Testing (§ 491.12 (d)) Although we believe that non- will be minimal, if any. Therefore, the We expect RHCs and FQHCs to accredited CAHs are currently total economic impact of this rule on participate in their local and state participating in such drills and these organizations will be limited to emergency plans and training drills to exercises, we are not convinced that it the estimated ICR burden of $9,586,150. is at the level that will be required identify local and regional disaster under this final rule. Thus, we will Q. Condition of Participation: centers that could provide shelter analyze the economic impact for these Emergency Preparedness for during an emergency. requirements for the 892 non-accredited Community Mental Health Centers We proposed that an RHC/FQHC must CAHs. As discussed earlier in the (CMHCs)—Training and Testing review and update its emergency preamble, CAHs will have access to (§ 485.920(d)) preparedness policies and procedures at various training resources and Section 485.920(d)(2) will require least annually. For purposes of emergency preparedness initiatives to CMHCs to participate in or conduct a determining the economic impact for use in complying with this requirement. full-scale exercise and one additional this requirement, we expect that RHCs/ Thus, we believe that the cost associated testing exercise of their choice at least FQHCs will review their emergency with this requirement will be limited to annually. We estimate that to comply preparedness policies and procedures staff time to participate in the with the requirement to participate in annually. Based on our experience with community-wide and facility-wide these testing exercises annually will Medicare providers and suppliers, trainings, and testing exercises. We primarily require the involvement of the healthcare facilities have a compliance believe that appreciable staff time will administrator and a registered nurse. We officer or other staff member who be required of the administrator, estimate that the administrator will reviews the facility’s program facilities director, director of nursing spend approximately 5 hours to periodically to ensure that it complies and nursing education coordinator. We participate in these testing exercises. We with all relevant federal, state, and local believe that other staff members will be also estimate that a nurse will spend laws, regulations, and ordinances. We required to spend a minimal amount of about 3 hours on an annual basis to believe that complying with the time during these exercises that will be participate in the testing exercises. requirement for an annual review of the considered as part of regular on-going Thus, we anticipate that complying with emergency preparedness policies and

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procedures will constitute a minimal each RHC for an estimated cost of $672 believe that dialysis facilities are economic impact, if any. per facility. The total annual cost for currently participating in community or 4,200 RHCs will be $4,905,600. 2. Testing (§ 491.12(d)(2)(i) Through facility-wide drills. Therefore, for the Therefore, the total economic impact of (iii)) purpose of this impact analysis, we this rule on RHCs/FQHCs will be estimate that dialysis facilities will need Section 491.12(d)(2)(i) through (iii) $57,372,600 ($4,905,600 impact cost + to add the additional testing exercise of will require RHCs/FQHCs to participate $52,467,000 ICR burden). their choice to their emergency in a full-scale exercise and one T. Condition of Participation: preparedness activities. We estimate additional testing exercise of their that it will require 1 hour each for the choice at least annually. We have stated Emergency Preparedness for End-Stage Renal Disease Facilities (Dialysis administrator (hourly wage of $106.00) previously that FQHCs are currently and the nurse manager (hourly wage of required to conduct annual drills. We Facilities)—Testing (§ 494.62(d)(2)(i) $94.00) to conduct the additional believe that for FQHCs to comply with Through (iv)) exercise. We estimate the total cost to be these requirements will constitute a Section 494.62(d)(2) will require $200 for each facility, with a total minimal economic impact, if any. Thus, dialysis facilities to participate in or economic impact of $1,329,600 ($200 × we are estimating the economic impact conduct a full-scale exercise and one for RHCs to comply with these additional testing exercise of their 6,648 facilities). Therefore, the total requirements to conduct testing choice at least annually. The current economic impact of this rule on ESRD exercises. We estimate that a RHCs CfCs already require dialysis facilities to facilities will be $32,960,784 administrator will spend 4 hours evaluate their emergency preparedness ($1,329,600 impact cost + $31,631,184 annually to participate in the exercises. plan at least annually ICR burden). Also, we estimate that a nurse (§ 494.60(d)(4)(ii)). Thus, we expect that U. Summary of the Total Costs coordinator (registered nurse) will each all dialysis facilities are already spend 4 hours on an annual basis to conducting some type of tests to The following is a summary of the participate in the testing exercises. evaluate their emergency plans. total providers and the annual cost Thus, we anticipate that complying with Although the current CfCs do not estimates for all providers to comply this requirement will require 8 hours for specify the type of drill or test, we with the requirements in this rule.

TABLE 129—TOTAL ANNUAL COST TO PARTICIPATE IN DISASTER DRILLS ACROSS THE PROVIDERS/SUPPLIERS

Number of Total cost Facility participants (in millions $)

RNHCI ...... 18 0.01 ASC ...... 5,485 3.97 Hospices ...... 4,401 2.46 PRTFs ...... 377 0.24 PACE ...... 119 0.02 Hospital ...... 4,793 6.71 HHAs ...... 12,335 2.95 CAHs ...... 1,337 1.66 CMHCs ...... 198 0.14 OPOs ...... 58 0.01 RHCs & FQHCs ...... 11,500 4.91 ESRD ...... 6,648 1.33

Total ...... 47,269 25.37

Based upon the ICR and RIA analyses, all of its requirements with an estimated assessment and developing an EP plan, it will require 62,968 providers and total first-year cost of $373 million. the annual cost for the total providers suppliers covered by this emergency After the initial cost of $373 million and suppliers to test their plans and preparedness final rule to comply with associated with conducting a risk train staff will be $25 million.

TABLE 130—TOTAL ESTIMATED COST FROM ICR AND RIA TO COMPLY WITH THE REQUIREMENTS CONTAINED IN THIS FINAL RULE

Total cost Total cost in year 2 and Facility Number of in year 1 subsequent participants (in millions of $) years (in millions of $)

RNHCI ...... 18 0.04 0.01 ASC ...... 5,485 22.37 3.97 Hospices ...... 4,401 22.43 2.46 PRTFs ...... 377 1.47 0.24 PACE ...... 119 0.65 0.02 Hospital ...... 4,793 46.14 6.71 Transplant Center ...... 770 0.00 0.00 LTC ...... 15,699 68.81 0.00 ICF/IID ...... 6,237 22.30 0.98

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TABLE 130—TOTAL ESTIMATED COST FROM ICR AND RIA TO COMPLY WITH THE REQUIREMENTS CONTAINED IN THIS FINAL RULE—Continued

Total cost Total cost in year 2 and Facility Number of in year 1 subsequent participants (in millions of $) years (in millions of $)

HHAs ...... 12,335 75.62 2.95 CORFs ...... 205 0.93 0.00 CAHs ...... 1,337 10.83 1.66 Organizations ...... 2,135 9.59 0.00 CMHCs ...... 198 1.09 0.14 OPOs ...... 58 1.13 0.01 RHCs & FQHCs ...... 11,500 57.37 4.91 ESRD Facilities ...... 6,648 34.29 1.33

Total ...... 72,315 $373 $25

The previous summaries include only such as health centers, rural hospitals adversely impacted by healthcare the upfront and routine costs associated and private physicians will be looked to disruptions following an emergency or with emergency risk assessment, for minimizing the loss of life and disaster. A 2008 study concluded that development and updating of policies permanent disabilities. Hospitals and many Hurricane Katrina survivors with and procedures, development and other healthcare provider organizations mental disorders experienced unmet maintenance of communication plans, must be able to work not only inside treatment needs, including frequent disaster training and testing, and their own walls, but also as a team disruptions of existing care and generator testing (as specified). If these during an emergency to respond widespread failure to initiate treatment preparations are effective, they will lead efficiently. Based on our experience, for new-onset disorders (Wang, P.S., et to increased amounts of life-saving and hospitals currently, either through al. ‘‘Disruption of Existing Mental morbidity-reducing activities during experience or empirical evidence, gain Health Treatments and Failure to emergency events. These activities knowledge that causes them to become Initiate New Treatment After Hurricane impose cost on society; for example, if very adept at adjusting their systems to Katrina. American Journal of Psychiatry, complying with this final rule’s respond in an emergency. Because we 165(1), 34–41)’’ (2006). requirements allows an ESRD facility to live under the threat of mass casualties Hospital closures during Sandy remain open during and immediately occurring at anytime and anywhere with resulted in up to a 25 percent increase after a natural disaster, there will be consequences that may be different than in emergency department visits at associated increases in provision of the day-to-day occurrences, the numerous centers in New York and a 70 dialysis services, thus entailing labor, healthcare system must be prepared to percent increase in ambulance traffic. material and other costs. As discussed respond to these events by working as Not only do vulnerable populations in the next section (‘‘Benefits of the a team or community system. experience disruptions in care, they Final Rule’’), it is difficult to predict This final rule serves to help ensure may also incur increased costs for care, how disaster responses will be different continuity of care and service delivery especially when those who require in the presence of this final rule than in for those that depend on the healthcare ongoing medical treatment during its absence, so we have been unable to system both daily and in the event of a disasters are required to visit emergency quantify the portion of costs that will be disaster by requiring providers and departments for treatment and or incurred during emergencies. suppliers to adequately plan for and hospitalization. (Absorbing citywide respond to both natural and man-made patient surge during Hurricane Sandy: a V. Benefits of the Final Rule disasters. The devastation of the Gulf case study in accommodating multiple The Presidential Policy Directive/ Coast by Hurricane Katrina is one of the hospital evacuations.) (Ann Emerg Med. PPD–8 is aimed at strengthening the most horrific disasters in our nation’s 2014 Jul ;64(1):66–73.e1. doi: 10.1016/ security and resilience of the United history. In those chaotic early days j.annemergmed.2013.12.010. Epub 2014 States through systematic preparation following the disaster in the greater New Jan 10.); (Howard D, Zhang R, Huang Y, for the threats that pose the greatest risk Orleans area, hundreds of thousands of Kutner N. Hospitalization rates among to the security of the nation, including people were adversely impacted, and dialysis patients during Hurricane acts of terrorism, cyber-attacks, healthcare services were not available Katrina. Prehosp Disaster Med. pandemics, and catastrophic natural for many who needed them. Rudowitz, 2012;27(4):1–5.).) disasters. (https://www.dhs.gov/ Robin, Diane Rowland, and Adele Emergency department visits incur a presidential-policy-directive-8-national- Shartzer. ‘‘Health care in New Orleans copay for most beneficiaries. Similar preparedness). ‘‘Having systems in before and after Hurricane Katrina.’’ costs are also incurred by patients for place to provide better treatment for Health Affairs 25.5(2006): w393–w406. . hospitalizations. The literature shows disaster survivors and improved public There is no reason to believe that future that natural catastrophes health for our communities also leads to disasters might not be as large or larger. disproportionately affect ill and better health outcomes on a day-to-day In the event of such disasters, socioeconomically disadvantaged basis.’’ http://www.phe.gov/ vulnerable populations are at greatest populations that are most at risk (Abdel- Preparedness/planning/hpp/Pages/ risk for negative consequences from Kader K, Unrah ML. Disaster and end- funding.aspx. As frontline entities in healthcare disruptions. Individuals stage renal disease: targeting vulnerable response to mass casualty incidents, requiring mental health treatments are patients for improved outcomes. Kidney hospitals and other healthcare providers another at-risk population that can be Int. 2009;75:1131–1133; Zoraster R,

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Vanholder R, Sever MS. Disaster reports/ame/path-storm) that studied public health impacts related to climate management of chronic dialysis FEMA disaster declaration and other change in the U.S. that will also inform patients. Am J Disaster Med. data from 2007 through 2012 found that state, and local governments and 2007;2(2):96–106; and Redlener I, Reilly federally declared weather-related communities on climate change risks. M. Lessons from Sandy—Preparing disasters in the United States have taken (see https://www.whitehouse.gov/sites/ Health Systems for Future Disasters. N place in every state except for one, and default/files/docs/the_health_impacts_ ENGL J MED. 367;24:2269–2271). affected every county in 18 states and of_climate_change_on_americans_ We know that advance planning the District of Columbia. It also found final.pdf and http:// improves disaster response. In 2007, that more than 19 million Americans www.globalchange.gov/health- Modern Healthcare reported on a live in counties that have an average of assessment. healthcare system’s response to one or more weather-related disasters According to the CDC, changing encroaching wildfires in California. per year since the beginning of 2007.’’ climate is linked to increases in a wide Staff from a San Diego hospital and (http://www.environmentamerica.org/ range of non-communicable and adjacent nursing facility transported 202 reports/ame/path-storm). Sometimes, infectious diseases. There are complex patients and ensured all patients were these disasters can have adverse impacts ways in which climatic factors (like out of harm’s way. The facilities were on the health of communities. For temperature, humidity, precipitation, ready because of protocols and example, more than 15,000 dialysis extreme weather events, and sea-level evacuation drills instituted after a prior patients located within the State of New rise) can directly or indirectly affect the event that allowed them to be prepared Jersey and New York City boroughs prevalence of disease. Identification of (Vesely, R. (2007). Wildfires worry were exposed to the impacts of communities and places vulnerable to hospitals. Modern Healthcare, 37(43), Hurricane Sandy that resulted in these changes can help healthcare 16). significant treatment disruptions. Therefore, we believe that it is (Kelman, Jeffrey, et al. ‘‘Dialysis care providers prepare to work with health essential to require providers and and death following Hurricane Sandy.’’ departments as they assess such health suppliers to conduct a risk assessment, American Journal of Kidney Diseases vulnerabilities associated with climate to develop an emergency preparedness 65.1 (2015): 109–115). change and prevent associated adverse plan based on the assessment, and to The White House, in July 2014, also health impacts. CDC has developed the comply with the other requirements we released a report titled ‘‘The Health Building Resilience Against Climate propose to minimize the disruption of Impacts of Climate Change on Effects (BRACE) framework to help services for the community and ensure Americans’’ (https:// health departments prepare for and continuity of care in the event of a www.whitehouse.gov/sites/default/files/ respond to climate change. Additional disaster. As noted previously, we have docs/the_health_impacts_of_climate_ information can be found at: http:// varied our requirements by provider change_on_americans_final.pdf). The www.cdc.gov/climateandhealth/ type and understand that the degree of report states that extreme heat brace.htm. vulnerability of patients in a disaster exposures for the period of 1999–2009 While we are unable to quantify the will vary according to provider type. For caused more than 7,800 deaths in the number of lives that could be saved by example, patients with scheduled U.S. As climate change progresses, emergency planning and execution, outpatient appointments such as extreme heat will ‘‘also increase Table 131 provides the number of someone coming in for speech therapy hospital admissions for cardiovascular, Medicare FFS beneficiaries receiving or routine clinic services is likely more respiratory, cerebrovascular diseases services from some of the provider types self-reliant in a disaster than someone in and deaths from heat stroke and other affected by this final rule during the a hospital ICU or someone who is related conditions (https:// month of May 2016. We are unable to homebound and receiving services from health2016.globalchange.gov.’’ On April provide volume data for those patients an HHA. 4, 2016, The White House also in Medicare Advantage plans or the Overall, we believe that this final rule published the Climate and Health Medicaid population. However, one will reduce the risk of mortality and Assessment Report’’ (https:// could assume the May 2016 summary is morbidity associated with disasters. www.whitehouse.gov/the-press-office/ representative of an average month While New Orleans has a unique 2016/04/04/fact-sheet-what-climate- during the year. In the event of a location, below sea level, everywhere in change-means-your-health-and-family disaster, a portion of the fee-for-service the United States is vulnerable to (actual report: https:// patients represented in Table 131 could weather emergencies and other potential health2016.globalchange.gov/) that be at risk; therefore, we could assume natural or manmade disasters. A recent provides a comprehensive, evidenced- that they could benefit from the report, ‘‘In the path of the Storm’’ based, and where possible quantitative additional emergency preparedness (http://www.environmentamerica.org/ estimation of observed and projected measures in this final rule.

TABLE 131—NUMBER OF MEDICARE FFS PATIENTS WHO RECEIVED SERVICES MAY 2016

Number of Provider type FFS patients

Children’s hospital ...... 3,731 Community Mental Health Center ...... 96,583 Comprehensive Outpatient Rehabilitation Facility ...... 3,673 Critical Access Hospital ...... 685,912 HHA ...... 1,043,827 Hospice ...... 322,565 Hospital based chronic renal disease facility ...... 7,700 Long-term hospital ...... 18,842 Non hospital renal disease treatment center ...... 280,189 ORD demonstration project hospital ...... 3,078

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TABLE 131—NUMBER OF MEDICARE FFS PATIENTS WHO RECEIVED SERVICES MAY 2016—Continued

Number of Provider type FFS patients

Psychiatric hospital ...... 37,975 Rehabilitation hospital ...... 45,995 Religious Nonmedical Health Care Institution ...... 29 Renal disease treatment center ...... 7,221 Reserved number ...... 68,734 Rural health clinic (free standing) ...... 208,942 Rural health clinic (provider based) ...... 325,051 Short-term hospital ...... 7,104,897 Skilled Nursing Facility ...... 539,061 Note: In May 2016 there were 9,283,219 distinct patients.

Benefits from effective disaster office based visit was $199 versus $922 • Reduce healthcare system stress by planning will not only accrue to for an emergency room visit (Machlin, remaining open or re-opening quickly individuals requiring healthcare S., and Chowdhury, S. ‘‘Expenses and following closure. This will decrease the services. Healthcare facilities Characteristics of Physician Visits in rate of interrupted dialysis, thereby themselves may benefit from improved Different Ambulatory Care Settings, reducing preventable ED visits, ability to maintain or resume delivering 2008.’’ Statistical Brief #318. March hospitalizations, and mortality during services. After Hurricane Katrina, 94 2011. Agency for Healthcare Research and following disasters. dialysis facilities closed for at least 1 and Quality, Rockville, MD. http:// W. Alternatives Considered week. More than a month after super www.meps.ahrq.gov/mepsweb/data_ storm Sandy devastated flood-prone files/publications/st318/stat318.pdf). 1. No Regulatory Action communities in New Jersey and New With the annualized costs of the rule’s As previously discussed, the status York, five hospitals were unable to emergency preparedness requirements quo is not a desirable alternative admit patients because of damage that estimated to be approximately $100 because the current regulatory destroyed electrical systems, flooded million depending on the discount rate requirements for Medicare and emergency and exam rooms and used (see the accounting statement table Medicaid providers and suppliers crippled elevators. Following Hurricane that follows) and the rule generating addressing emergency and disaster Sandy, $180 million of the $810 million additional, unquantified costs preparedness are insufficient to protect damages reported by the New York City associated with the life-saving activities beneficiaries and other patients during a Health and Hospitals Corporation was that become implementable as a result disaster. due to lost revenue. Lost revenue from of the preparedness requirements, this Long Beach Medical Center hospital and final rule will have to result in at least 2. Defer to Federal, State, and Local nursing home was estimated at $1.85 $100 million in average yearly benefits, Laws million a week after closing due to principally derived from reductions in Another alternative we considered damage from Hurricane Sandy. http:// morbidity and mortality, for the benefits was to propose a regulation that would www.modernhealthcare.com/article/ to equal or exceed costs. ASPR and require Medicare providers and 20121208/MAGAZINE/ CMS, using Medicare claims data, suppliers to comply with local, state 312089991#ixzz2adUDjFIE?trk=tynt. conducted an analysis of the impact of and federal laws regarding emergency Finally, taxpayers and insurance Hurricane Sandy on dialysis-dependent and disaster planning. Various federal, companies may benefit from effective ESRD patients. The study found a state and local entities (FEMA, the emergency preparedness. After significant increase in emergency National Response Plan (NRP), CDC, the Hurricane Ike, it was estimated that the department visits, hospitalizations, and Assistant Secretary for Preparedness cost to Medicare for ESRD patients 30-day mortality for ESRD patients and Response (ASPR), et al) have presenting to the ED for dialysis instead living in the areas most affected by the disaster management plans that provide of their usual facility was, on average, storm (Kelman, et al.). Approximately an integrated process that involves all $6,997 per visit. Those ESRD patients 23 percent of the study patients who local and regional emergency who did not require dialysis were billed had an emergency visit also received responders. We also considered $482 on average (McGinley et al, 2012). dialysis in the ED during their visits allowing healthcare providers to The usual cost for these patients as (Kelman, et al.). (Kelman, Jeffrey, et al. voluntarily implement a comprehensive reimbursed through Medicare is in the ‘‘Dialysis care and death following emergency preparedness program order of $250 to 300 per visit. Many of Hurricane Sandy.’’ American Journal of utilizing grant funding from the Office these costs or lost revenues may be Kidney Diseases 65.1 (2015): 109–115.) of the Assistant Secretary for mitigated by effective emergency Adoption of the following requirements Preparedness and Response, (ASPR). preparedness planning. For a non-ESRD in this final rule will better enable Based on a 2010 survey of the American individual who cannot receive care from individual facilities to— College of Healthcare Executives his or her office-based physician but • Anticipate threats; (ACHE), less than 1 percent of hospital must instead go to an emergency room, • Rapidly activate plans, processes CEOs identified ‘‘disaster preparedness’’ not only are the individual’s costs and protocols; as a top priority. Also, a 2012 survey of increased, but reimbursement through • Quickly communicate with their 1,202 community hospital CEOs (found Medicare, Medicaid or private insurance patients, other facilities and state or at: http://www.ache.org/Pubs/Releases/ is also increased. AHRQ’s Medical local officials to ensure continuity of 2013/Top-Issues-Confronting-Hospitals- Expenditure Panel Survey from 2008 care for these life maintaining services; 2012.cfm) of ASPR’s Hospital notes that the average expense for an and Preparedness Program (HPP) showed

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that disaster preparedness was not an as-needed basis to address changes in finalized, we will update the identified as a top issue. We believe that clinical practice, patient needs, and interpretive guidance, update the survey absent conditions of participation, public health issues. The responses to process, and make IT systems changes. certification, and coverage, providers the various past disasters demonstrated In order to implement these new and suppliers will not consistently that our current regulations are in need standards, we anticipate initial federal adhere to the various local, state and of improvement in order to protect start-up costs to be $700,000. Once federal emergency preparedness patients, residents, and clients during implemented, surveys will begin in requirements. Moreover, many such an emergency and that emergency FY17 and we anticipate initial costs for instructions are unclear as to what is preparedness for healthcare providers these surveys to carry into FY18 due to mandatory or only strongly and suppliers is an urgent public health the survey cycle. Therefore, we recommended, and written in ways that issue. Therefore, we are finalizing anticipate approximately $4,411,286 for leave compliance difficult or impossible emergency preparedness requirements to determine consistently across that are consistent and enforceable for FY18 with a decrease in subsequent providers. Such inconsistent application all Medicare and Medicaid providers years to an estimated $3,749,593 of local, state, and federal requirements and suppliers. This final rule addresses annually in federal costs. could compound the problems faced by the three key elements needed to ensure Y. Accounting Statement governments, healthcare organizations, that healthcare is available during and citizens during a disaster. In emergencies: Safeguarding human As required by OMB Circular A–4 addition, our regulations will enable us resources, ensuring business continuity, (available at http:// to survey and enforce the emergency and protecting physical resources. www.whitehouse.gov/omb/circular/ preparedness requirements using Current regulations for Medicare and a004/a-4.pdf), we have prepared an standard processes and criteria. Medicaid providers and suppliers do accounting statement. As previously not adequately address these key 3. Conclusion explained, achieving the full scope of elements. potential savings will depend on the We currently have regulations for number of lives affected or saved as a Medicare and Medicaid providers and X. Costs to Federal Government result of this regulation. suppliers to protect the health and Surveyors will be trained and safety of Medicare beneficiaries and interpretive guidelines will be others. We revise these regulations on developed. If these requirements are

TABLE 132—ACCOUNTING STATEMENT

Units Category Estimates Period Year dollar Discount rate covered

Benefits

Qualitative ...... Help ensure the safety of individuals by requiring providers and suppliers to adequately plan for and respond to both natural and man-made disasters.

Costs * Annualized Monetized ($million/year) ...... 104 2015 7% 2016–2020 99 2015 3% 2016–2020

Qualitative ...... Costs of performing life-saving and morbidity-reducing activities during emergency events.

In accordance with the provisions of suppliers to come into compliance with under previous sections of this rule. We Executive Order 12866, this final rule the proposed requirements. For have increased the overhead cost to 100 was reviewed by the Office of example, tasks such as updating policies percent of salary. In addition, based on Management and Budget. and procedures involve more than our experience with the Medicare and Comment: A commenter stated that assembling key hospital staff to attend a Medicaid providers, most providers the figures used for economic impact, limited number of meetings, draft have some type of an emergency plan not including the ICR burden are revisions and obtain approval. Updating and agree that it is very important to underestimated by 45 percent. Several policies and procedures also involves appropriately plan for a potential other commenters stated that they researching alternatives, assessing any emergency or disaster. We believe that believe that our projections of burden costs involved (such as technology that these providers currently inform or train and cost for compliance with the may be needed), reviewing potential their staff on some type of an emergency proposed rule are underestimated. They changes with employees who may be stated that many hospitals, especially affected, implementing the changes, plan with various degrees of smaller hospitals, have expressed training staff and testing outcomes. effectiveness. We realize that these concern about the financial implications Response: We appreciate all of the requirements will require providers and for compliance with certain provisions, public comments we received regarding suppliers to consistently conduct especially the additional generator the cost and burden estimates for this additional assessment, and development testing. In addition, they stated that we rule. We carefully reviewed the public of policies and procedures and have underestimated the amount of time and comments and have discussed many of added additional cost for the projected work it will take many providers and the comments that will reduce burden personnel time associated with this rule.

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As previously discussed, we will relations, Medicare, Reporting and PART 403—SPECIAL PROGRAMS AND remove the burden and cost for recordkeeping requirements. PROJECTS hospitals, CAHs and LTC facilities to 42 CFR Part 416 conduct an additional testing of their ■ 1. The authority citation for part 403 generators. We have also provided Health facilities, Health professions, continues to read as follows: flexibility under the training and testing Medicare, Reporting and recordkeeping Authority: 42 U.S.C. 1395b-3 and Secs. requirements and we have increased the requirements. 1102 and 1871 of the Social Security Act (42 salary cost for the staff that will 42 CFR Part 418 U.S.C. 1302 and 1395hh). participate in complying with this rule. Health facilities, Hospice care, § 403.742 [Amended] VI. Waiver of Proposed Rulemaking Medicare, Reporting and recordkeeping ■ 2. Amend § 403.742 by— ■ We ordinarily publish a notice of requirements. a. Removing paragraphs (a)(1), (4), and (5). proposed rulemaking in the Federal 42 CFR Part 441 ■ Register and invite public comment on b. Redesignating paragraphs (a)(2) and Aged, Family planning, Grant the proposal. The notice of proposed (3) as paragraphs (a)(1) and (2), programs-health, Infants and children, rule includes a reference to the legal respectively. Medicaid, Penalties, Reporting and ■ c. Redesignating paragraphs (a)(6) authority under which the rule is recordkeeping requirements. through (8) as paragraphs (a)(3) through proposed, and the terms and substance (5), respectively. of the proposed rule or a description of 42 CFR Part 460 ■ 3. Add § 403.748 to read as follows: the subjects and issues involved. This Aged, Health care, Health records, procedure can be waived, however, if an Medicaid, Medicare, Reporting and § 403.748 Condition of participation: agency finds good cause that a notice- recordkeeping requirements. Emergency preparedness. and-comment procedure is The Religious Nonmedical Health impracticable, unnecessary, or contrary 42 CFR Part 482 Care Institution (RNHCI) must comply to the public interest and incorporates a Grant programs-health, Hospitals, with all applicable Federal, State, and statement of the finding and its reasons Medicaid, Incorporation by reference, local emergency preparedness in the rule issued. Medicare, Reporting and recordkeeping requirements. The RNHCI must In various sections of the December requirements. establish and maintain an emergency 2013 proposed rule (78 FR 79101), we preparedness program that meets the referenced the latest version of the Life 42 CFR Part 483 requirements of this section. The Safety Code (NFPA® 101), the Health Grant programs-health, Health emergency preparedness program must Care Facilities Code (NFPA® 99) and the facilities, Health professions, Health include, but not be limited to, the Standard for Standby Power Generators records, Incorporation by Reference, following elements: (NFPA® 110). In the May 4, 2016 Medicaid, Medicare, Nursing homes, (a) Emergency plan. The RNHCI must Federal Register (81 FR 26872) we Nutrition, Reporting and recordkeeping develop and maintain an emergency published a final rule, ‘‘Medicare and requirements, Safety. preparedness plan that must be Medicaid Programs: Fire Safety reviewed, and updated at least annually. 42 CFR Part 484 Requirements for Certain Health Care The plan must do all of the following: Facilities’’, which incorporated by Health facilities, Health professions, (1) Be based on and include a reference the 2012 editions of NFPA® Medicare, Reporting and recordkeeping documented, facility-based and 101, ‘‘Life Safety Code’’ and NFPA® 99, requirements. community-based risk assessment, utilizing an all-hazards approach. ‘‘Health Care Facilities Code’’ into our 42 CFR Part 485 regulations. In a similar manner in this (2) Include strategies for addressing final rule, we are incorporating by Grant programs-health, Health emergency events identified by the risk reference the 2012 editions of NFPA® facilities, Incorporation by Reference, assessment. 101, ‘‘Life Safety Code’’ and NFPA® 99, Medicaid, Medicare, Reporting and (3) Address patient population, ‘‘Health Care Facilities Code’’ as well as recordkeeping requirements. including, but not limited to, persons at- ® risk; the type of services the RNHCI has the 2010 edition of NFPA 110, 42 CFR Part 486 Standard for Emergency and Standby the ability to provide in an emergency; Power Systems. Because the December Grant programs-health, Health and, continuity of operations, including 2013 proposed rule referred to and facilities, Medicare, Reporting and delegations of authority and succession discussed incorporation of earlier recordkeeping requirements, X-rays. plans. versions of these NFPA documents, we 42 CFR Part 491 (4) Include a process for cooperation believe that engaging in a new round of and collaboration with local, tribal, notice-and-comment rulemaking to Grant programs-health, Health regional, State, and Federal emergency propose an update to these codes, which facilities, Medicaid, Medicare, preparedness officials’ efforts to have already been incorporated into our Reporting and recordkeeping maintain an integrated response during general fire safety regulations, would be requirements, Rural areas. a disaster or emergency situation, both unnecessary and contrary to the 42 CFR Part 494 including documentation of the public interest. Therefore, we find good RNHCI’s efforts to contact such officials Health facilities, Incorporation by cause to waive the notice of proposed and, when applicable, of its reference, Kidney diseases, Medicare, rulemaking related to these changes. participation in collaborative and Reporting and recordkeeping cooperative planning efforts. List of Subjects requirements. (b) Policies and procedures. The 42 CFR Part 403 For the reasons set forth in the RNHCI must develop and implement preamble, the Centers for Medicare and emergency preparedness policies and Grant programs-health, Health Medicaid Services amends 42 CFR procedures, based on the emergency insurance, Hospitals, Intergovernmental chapter IV as set forth below: plan set forth in paragraph (a) of this

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section, risk assessment at paragraph emergency preparedness (iv) Demonstrate staff knowledge of (a)(1) of this section, and the communication plan that complies with emergency procedures. communication plan at paragraph (c) of Federal, State, and local laws and must (2) Testing. The RNHCI must conduct this section. The policies and be reviewed and updated at least exercises to test the emergency plan. procedures must be reviewed and annually. The communication plan The RNHCI must do the following: updated at least annually. At a must include all of the following: (i) Conduct a paper-based, tabletop minimum, the policies and procedures (1) Names and contact information for exercise at least annually. A tabletop must address the following: the following: exercise is a group discussion led by a (1) The provision of subsistence needs (i) Staff. facilitator, using a narrated, clinically- for staff and patients, whether they (ii) Entities providing services under relevant emergency scenario, and a set evacuate or shelter in place, include, but arrangement. of problem statements, directed are not limited to the following: (iii) Next of kin, guardian or messages, or prepared questions (i) Food, water, and supplies. custodian. designed to challenge an emergency (ii) Alternate sources of energy to (iv) Other RNHCIs. plan. maintain the following: (v) Volunteers. (ii) Analyze the RNHCI’s response to (A) Temperatures to protect patient (2) Contact information for the and maintain documentation of all health and safety and for the safe and following: tabletop exercises, and emergency sanitary storage of provisions. (i) Federal, State, tribal, regional, and events, and revise the RNHCI’s (B) Emergency lighting. local emergency preparedness staff. emergency plan, as needed. (C) Fire detection, extinguishing, and (ii) Other sources of assistance. alarm systems. (3) Primary and alternate means for PART 416—AMBULATORY SURGICAL (D) Sewage and waste disposal. communicating with the following: SERVICES (2) A system to track the location of (i) RNHCI’s staff. on-duty staff and sheltered patients in (ii) Federal, State, tribal, regional, and ■ 4. The authority citation for part 416 the RNHCI’s care during an emergency. local emergency management agencies. continues to read as follows: If on-duty staff and sheltered patients (4) A method for sharing information Authority: Secs. 1102 and 1871 of the are relocated during the emergency, the and care documentation for patients Social Security Act (42 U.S.C. 1302 and RNCHI must document the specific under the RNHCI’s care, as necessary, 1395hh). name and location of the receiving with care providers to maintain the facility or other location. continuity of care, based on the written § 416.41 [Amended] (3) Safe evacuation from the RNHCI, election statement made by the patient ■ 5. Amend § 416.41 by removing which includes the following: or his or her legal representative. paragraph (c). (i) Consideration of care needs of (5) A means, in the event of an ■ 6. Add § 416.54 to subpart C to read evacuees. evacuation, to release patient as follows: (ii) Staff responsibilities. information as permitted under 45 CFR (iii) Transportation. 164.510(b)(1)(ii). § 416.54 Condition for coverage— (iv) Identification of evacuation (6) A means of providing information Emergency preparedness. location(s). about the general condition and location The Ambulatory Surgical Center (v) Primary and alternate means of of patients under the facility’s care as (ASC) must comply with all applicable communication with external sources of permitted under 45 CFR 164.510(b)(4). Federal, State, and local emergency assistance. (7) A means of providing information preparedness requirements. The ASC (4) A means to shelter in place for about the RNHCI’s occupancy, needs, must establish and maintain an patients, staff, and volunteers who and its ability to provide assistance, to emergency preparedness program that remain in the facility. the authority having jurisdiction, the meets the requirements of this section. (5) A system of care documentation Incident Command Center, or designee. The emergency preparedness program that does the following: (d) Training and testing. The RNHCI must include, but not be limited to, the (i) Preserves patient information. must develop and maintain an following elements: (ii) Protects confidentiality of patient emergency preparedness training and (a) Emergency plan. The ASC must information. testing program that is based on the develop and maintain an emergency (iii) Secures and maintains the emergency plan set forth in paragraph preparedness plan that must be availability of records. (a) of this section, risk assessment at reviewed, and updated at least annually. (6) The use of volunteers in an paragraph (a)(1) of this section, policies The plan must do the following: emergency and other emergency staffing and procedures at paragraph (b) of this (1) Be based on and include a strategies to address surge needs during section, and the communication plan at documented, facility-based and an emergency. paragraph (c) of this section. The community-based risk assessment, (7) The development of arrangements training and testing program must be utilizing an all-hazards approach. with other RNHCIs and other providers reviewed and updated at least annually. (2) Include strategies for addressing to receive patients in the event of (1) Training program. The RNHCI emergency events identified by the risk limitations or cessation of operations to must do all of the following: assessment. maintain the continuity of nonmedical (i) Initial training in emergency (3) Address patient population, services to RNHCI patients. preparedness policies and procedures to including, but not limited to, the type of (8) The role of the RNHCI under a all new and existing staff, individuals services the ASC has the ability to waiver declared by the Secretary, in providing services under arrangement, provide in an emergency; and accordance with section 1135 of Act, in and volunteers, consistent with their continuity of operations, including the provision of care at an alternate care expected roles. delegations of authority and succession site identified by emergency (ii) Provide emergency preparedness plans. management officials. training at least annually. (4) Include a process for cooperation (c) Communication plan. The RNHCI (iii) Maintain documentation of all and collaboration with local, tribal, must develop and maintain an emergency preparedness training. regional, State, and Federal emergency

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preparedness officials’ efforts to annually. The communication plan community-based exercise is not maintain an integrated response during must include all of the following: accessible, individual, facility-based. If a disaster or emergency situation, (1) Names and contact information for the ASC experiences an actual natural including documentation of the ASC’s the following: or man-made emergency that requires efforts to contact such officials and, (i) Staff. activation of the emergency plan, the when applicable, of its participation in (ii) Entities providing services under ASC is exempt from engaging in an collaborative and cooperative planning arrangement. community-based or individual, facility- efforts. (iii) Patients’ physicians. based full-scale exercise for 1 year (b) Policies and procedures. The ASC (iv) Volunteers. following the onset of the actual event. must develop and implement (2) Contact information for the (ii) Conduct an additional exercise emergency preparedness policies and following: that may include, but is not limited to procedures, based on the emergency (i) Federal, State, tribal, regional, and the following: plan set forth in paragraph (a) of this local emergency preparedness staff. (A) A second full-scale exercise that is section, risk assessment at paragraph (ii) Other sources of assistance. individual, facility-based. (a)(1) of this section, and the (3) Primary and alternate means for (B) A tabletop exercise that includes communication plan at paragraph (c) of communicating with the following: a group discussion led by a facilitator, this section. The policies and (i) ASC’s staff. using a narrated, clinically-relevant procedures must be reviewed and (ii) Federal, State, tribal, regional, and emergency scenario, and a set of updated at least annually. At a local emergency management agencies. problem statements, directed messages, minimum, the policies and procedures (4) A method for sharing information or prepared questions designed to must address the following: and medical documentation for patients challenge an emergency plan. (1) A system to track the location of under the ASC’s care, as necessary, with (iii) Analyze the ASC’s response to on-duty staff and sheltered patients in other health care providers to maintain and maintain documentation of all the ASC’s care during an emergency. If the continuity of care. drills, tabletop exercises, and emergency on-duty staff or sheltered patients are (5) A means, in the event of an events and revise the ASC’s emergency relocated during the emergency, the evacuation, to release patient plan, as needed. ASC must document the specific name information as permitted under 45 CFR (e) Integrated healthcare systems. If and location of the receiving facility or 164.510(b)(1)(ii). an ASC is part of a healthcare system other location. (6) A means of providing information consisting of multiple separately (2) Safe evacuation from the ASC, about the general condition and location certified healthcare facilities that elects which includes the following: of patients under the facility’s care as to have a unified and integrated (i) Consideration of care and permitted under 45 CFR 164.510(b)(4). emergency preparedness program, the treatment needs of evacuees. (7) A means of providing information ASC may choose to participate in the (ii) Staff responsibilities. about the ASC’s needs, and its ability to healthcare system’s coordinated (iii) Transportation. provide assistance, to the authority emergency preparedness program. If (iv) Identification of evacuation having jurisdiction, the Incident elected, the unified and integrated location(s). Command Center, or designee. emergency preparedness program (v) Primary and alternate means of (d) Training and testing. The ASC must— communication with external sources of must develop and maintain an (1) Demonstrate that each separately assistance. emergency preparedness training and certified facility within the system (3) A means to shelter in place for testing program that is based on the actively participated in the development patients, staff, and volunteers who emergency plan set forth in paragraph of the unified and integrated emergency remain in the ASC. (a) of this section, risk assessment at preparedness program. (4) A system of medical paragraph (a)(1) of this section, policies (2) Be developed and maintained in a documentation that does the following: and procedures at paragraph (b) of this manner that takes into account each (i) Preserves patient information. section, and the communication plan at separately certified facility’s unique (ii) Protects confidentiality of patient paragraph (c) of this section. The circumstances, patient populations, and information. training and testing program must be services offered. (iii) Secures and maintains the reviewed and updated at least annually. (3) Demonstrate that each separately availability of records. (1) Training program. The ASC must certified facility is capable of actively (5) The use of volunteers in an do all of the following: using the unified and integrated emergency and other staffing strategies, (i) Initial training in emergency emergency preparedness program and is including the process and role for preparedness policies and procedures to in compliance. integration of State and Federally all new and existing staff, individuals (4) Include a unified and integrated designated health care professionals to providing on-site services under emergency plan that meets the address surge needs during an arrangement, and volunteers, consistent requirements of paragraphs (a)(2), (3), emergency. with their expected roles. and (4) of this section. The unified and (6) The role of the ASC under a (ii) Provide emergency preparedness integrated emergency plan must also be waiver declared by the Secretary, in training at least annually. based on and include the following: accordance with section 1135 of the Act, (iii) Maintain documentation of all (i) A documented community-based in the provision of care and treatment at emergency preparedness training. risk assessment, utilizing an all-hazards an alternate care site identified by (iv) Demonstrate staff knowledge of approach. emergency management officials. emergency procedures. (ii) A documented individual facility- (c) Communication plan. The ASC (2) Testing. The ASC must conduct based risk assessment for each must develop and maintain an exercises to test the emergency plan at separately certified facility within the emergency preparedness least annually. The ASC must do the health system, utilizing an all-hazards communication plan that complies with following: approach. Federal, State, and local laws and must (i) Participate in a full-scale exercise (5) Include integrated policies and be reviewed and updated at least that is community-based or when a procedures that meet the requirements

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set forth in paragraph (b) of this section, procedures, based on the emergency (1) Temperatures to protect patient a coordinated communication plan and plan set forth in paragraph (a) of this health and safety and for the safe and training and testing programs that meet section, risk assessment at paragraph sanitary storage of provisions. the requirements of paragraphs (c) and (a)(1) of this section, and the (2) Emergency lighting. (d) of this section, respectively. communication plan at paragraph (c) of (3) Fire detection, extinguishing, and this section. The policies and alarm systems. PART 418—HOSPICE CARE procedures must be reviewed and (C) Sewage and waste disposal. (iv) The role of the hospice under a ■ updated at least annually. At a 7. The authority citation for part 418 minimum, the policies and procedures waiver declared by the Secretary, in continues to read as follows: must address the following: accordance with section 1135 of the Act, Authority: Secs. 1102 and 1871 of the (1) Procedures to follow up with on- in the provision of care and treatment at Social Security Act (42 U.S.C. 1302 and duty staff and patients to determine an alternate care site identified by 1395hh). services that are needed, in the event emergency management officials. (v) A system to track the location of § 418.110 [Amended] that there is an interruption in services during or due to an emergency. The hospice employees’ on-duty and ■ 8. Amend § 418.110 by removing hospice must inform State and local sheltered patients in the hospice’s care paragraph (c)(1)(ii) and the paragraph officials of any on-duty staff or patients during an emergency. If the on-duty designation (i) from paragraph (c)(1)(i). that they are unable to contact. employees or sheltered patients are ■ 9. Add § 418.113 to read as follows: (2) Procedures to inform State and relocated during the emergency, the local officials about hospice patients in hospice must document the specific § 418.113 Condition of participation: name and location of the receiving Emergency preparedness. need of evacuation from their residences facility or other location. The hospice must comply with all at any time due to an emergency situation based on the patient’s medical (c) Communication plan. The hospice applicable Federal, State, and local must develop and maintain an emergency preparedness requirements. and psychiatric condition and home environment. emergency preparedness The hospice must establish and communication plan that complies with maintain an emergency preparedness (3) A system of medical documentation that preserves patient Federal, State, and local laws and must program that meets the requirements of be reviewed and updated at least this section. The emergency information, protects confidentiality of patient information, and secures and annually. The communication plan preparedness program must include, but must include all of the following: not be limited to, the following maintains the availability of records. (4) The use of hospice employees in (1) Names and contact information for elements: the following: (a) Emergency plan. The hospice must an emergency and other emergency staffing strategies, including the process (i) Hospice employees. develop and maintain an emergency (ii) Entities providing services under preparedness plan that must be and role for integration of State and Federally designated health care arrangement. reviewed, and updated at least annually. (iii) Patients’ physicians. professionals to address surge needs The plan must do the following: (iv) Other hospices. (1) Be based on and include a during an emergency. (2) Contact information for the documented, facility-based and (5) The development of arrangements following: community-based risk assessment, with other hospices and other providers (i) Federal, State, tribal, regional, and utilizing an all-hazards approach. to receive patients in the event of local emergency preparedness staff. (2) Include strategies for addressing limitations or cessation of operations to (ii) Other sources of assistance. emergency events identified by the risk maintain the continuity of services to (3) Primary and alternate means for assessment, including the management hospice patients. communicating with the following: of the consequences of power failures, (6) The following are additional (i) Hospice’s employees. natural disasters, and other emergencies requirements for hospice-operated (ii) Federal, State, tribal, regional, and that would affect the hospice’s ability to inpatient care facilities only. The local emergency management agencies. provide care. policies and procedures must address (4) A method for sharing information (3) Address patient population, the following: and medical documentation for patients including, but not limited to, the type of (i) A means to shelter in place for under the hospice’s care, as necessary, services the hospice has the ability to patients, hospice employees who with other health care providers to provide in an emergency; and remain in the hospice. maintain the continuity of care. continuity of operations, including (ii) Safe evacuation from the hospice, (5) A means, in the event of an delegations of authority and succession which includes consideration of care evacuation, to release patient plans. and treatment needs of evacuees; staff information as permitted under 45 CFR (4) Include a process for cooperation responsibilities; transportation; 164.510(b)(1)(ii). and collaboration with local, tribal, identification of evacuation location(s) (6) A means of providing information regional, State, or Federal emergency and primary and alternate means of about the general condition and location preparedness officials’ efforts to communication with external sources of of patients under the facility’s care as maintain an integrated response during assistance. permitted under 45 CFR 164.510(b)(4). a disaster or emergency situation, (iii) The provision of subsistence (7) A means of providing information including documentation of the needs for hospice employees and about the hospice’s inpatient hospice’s efforts to contact such officials patients, whether they evacuate or occupancy, needs, and its ability to and, when applicable, of its shelter in place, include, but are not provide assistance, to the authority participation in collaborative and limited to the following: having jurisdiction, the Incident cooperative planning efforts. (A) Food, water, medical, and Command Center, or designee. (b) Policies and procedures. The pharmaceutical supplies. (d) Training and testing. The hospice hospice must develop and implement (B) Alternate sources of energy to must develop and maintain an emergency preparedness policies and maintain the following: emergency preparedness training and

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testing program that is based on the emergency preparedness program, the reviewed, and updated at least annually. emergency plan set forth in paragraph hospice may choose to participate in the The plan must do the following: (a) of this section, risk assessment at healthcare system’s coordinated (1) Be based on and include a paragraph (a)(1) of this section, policies emergency preparedness program. If documented, facility-based and and procedures at paragraph (b) of this elected, the unified and integrated community-based risk assessment, section, and the communication plan at emergency preparedness program must utilizing an all-hazards approach. paragraph (c) of this section. The do the following: (2) Include strategies for addressing training and testing program must be (1) Demonstrate that each separately emergency events identified by the risk reviewed and updated at least annually. certified facility within the system assessment. (1) Training program. The hospice actively participated in the development (3) Address resident population, must do all of the following: of the unified and integrated emergency including, but not limited to, persons at- (i) Initial training in emergency preparedness program. risk; the type of services the PRTF has preparedness policies and procedures to (2) Be developed and maintained in a the ability to provide in an emergency; all new and existing hospice employees, manner that takes into account each and continuity of operations, including and individuals providing services separately certified facility’s unique delegations of authority and succession under arrangement, consistent with circumstances, patient populations, and plans. their expected roles. services offered. (4) Include a process for cooperation (ii) Demonstrate staff knowledge of (3) Demonstrate that each separately and collaboration with local, tribal, emergency procedures. certified facility is capable of actively regional, State, and Federal emergency (iii) Provide emergency preparedness using the unified and integrated preparedness officials’ efforts to training at least annually. emergency preparedness program and is maintain an integrated response during (iv) Periodically review and rehearse in compliance with the program. a disaster or emergency situation, its emergency preparedness plan with (4) Include a unified and integrated including documentation of the PRTF’s hospice employees (including emergency plan that meets the efforts to contact such officials and, nonemployee staff), with special requirements of paragraphs (a)(2), (3), when applicable, of its participation in emphasis placed on carrying out the and (4) of this section. The unified and collaborative and cooperative planning procedures necessary to protect patients integrated emergency plan must also be efforts. and others. based on and include the following: (b) Policies and procedures. The PRTF (v) Maintain documentation of all (i) A documented community-based must develop and implement emergency preparedness training. risk assessment, utilizing an all-hazards emergency preparedness policies and (2) Testing. The hospice must conduct approach. procedures, based on the emergency exercises to test the emergency plan at (ii) A documented individual facility- plan set forth in paragraph (a) of this least annually. The hospice must do the based risk assessment for each section, risk assessment at paragraph following: separately certified facility within the (a)(1) of this section, and the (i) Participate in a full-scale exercise health system, utilizing an all-hazards communication plan at paragraph (c) of that is community-based or when a approach. this section. The policies and community-based exercise is not (5) Include integrated policies and procedures must be reviewed and accessible, an individual, facility-based. procedures that meet the requirements updated at least annually. At a If the hospice experiences an actual set forth in paragraph (b) of this section, minimum, the policies and procedures natural or man-made emergency that a coordinated communication plan and must address the following: requires activation of the emergency training and testing programs that meet (1) The provision of subsistence needs plan, the hospital is exempt from the requirements of paragraphs (c) and for staff and residents, whether they engaging in a community-based or (d) of this section, respectively. evacuate or shelter in place, include, but individual, facility-based full-scale are not limited to the following: exercise for 1 year following the onset PART 441—SERVICES: (i) Food, water, medical, and of the actual event. REQUIREMENTS AND LIMITS pharmaceutical supplies. (ii) Conduct an additional exercise APPLICABLE TO SPECIFIC SERVICES (ii) Alternate sources of energy to that may include, but is not limited to maintain the following: the following: ■ 10. The authority citation for part 441 (A) Temperatures to protect resident (A) A second full-scale exercise that is continues to read as follows: health and safety and for the safe and community-based or individual, facility- Authority: Secs. 1102, 1902, and 1928 of sanitary storage of provisions. based. the Social Security Act (42 U.S.C. 1302). (B) Emergency lighting. (B) A tabletop exercise that includes ■ 11. Add § 441.184 to subpart D to read (C) Fire detection, extinguishing, and a group discussion led by a facilitator, as follows: alarm systems. using a narrated, clinically-relevant (D) Sewage and waste disposal. emergency scenario, and a set of § 441.184 Emergency preparedness. (2) A system to track the location of problem statements, directed messages, The Psychiatric Residential Treatment on-duty staff and sheltered residents in or prepared questions designed to Facility (PRTF) must comply with all the PRTF’s care during and after an challenge an emergency plan. applicable Federal, State, and local emergency. If on-duty staff and (iii) Analyze the hospice’s response to emergency preparedness requirements. sheltered residents are relocated during and maintain documentation of all The PRTF must establish and maintain the emergency, the PRTF must drills, tabletop exercises, and emergency an emergency preparedness program document the specific name and events, and revise the hospice’s that meets the requirements of this location of the receiving facility or other emergency plan, as needed. section. The emergency preparedness location. (e) Integrated healthcare systems. If a program must include, but not be (3) Safe evacuation from the PRTF, hospice is part of a healthcare system limited to, the following elements: which includes consideration of care consisting of multiple separately (a) Emergency plan. The PRTF must and treatment needs of evacuees; staff certified healthcare facilities that elects develop and maintain an emergency responsibilities; transportation; to have a unified and integrated preparedness plan that must be identification of evacuation location(s);

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and primary and alternate means of (7) A means of providing information to have a unified and integrated communication with external sources of about the PRTF’s occupancy, needs, and emergency preparedness program, the assistance. its ability to provide assistance, to the PRTF may choose to participate in the (4) A means to shelter in place for authority having jurisdiction, the healthcare system’s coordinated residents, staff, and volunteers who Incident Command Center, or designee. emergency preparedness program. If remain in the facility. (d) Training and testing. The PRTF elected, the unified and integrated (5) A system of medical must develop and maintain an emergency preparedness program must documentation that preserves resident emergency preparedness training do the following: information, protects confidentiality of program that is based on the emergency (1) Demonstrate that each separately resident information, and secures and plan set forth in paragraph (a) of this certified facility within the system maintains the availability of records. section, risk assessment at paragraph actively participated in the development (6) The use of volunteers in an (a)(1) of this section, policies and of the unified and integrated emergency emergency or other emergency staffing procedures at paragraph (b) of this preparedness program. strategies, including the process and section, and the communication plan at (2) Be developed and maintained in a role for integration of State and paragraph (c) of this section. The manner that takes into account each Federally designated health care training and testing program must be separately certified facility’s unique professionals to address surge needs reviewed and updated at least annually. circumstances, patient populations, and during an emergency. (1) Training program. The PRTF must services offered. (7) The development of arrangements do all of the following: (3) Demonstrate that each separately with other PRTFs and other providers to (i) Provide initial training in certified facility is capable of actively receive residents in the event of emergency preparedness policies and using the unified and integrated limitations or cessation of operations to procedures to all new and existing staff, emergency preparedness program and is maintain the continuity of services to individuals providing services under in compliance with the program. PRTF residents. arrangement, and volunteers, consistent (4) Include a unified and integrated (8) The role of the PRTF under a with their expected roles. emergency plan that meets the waiver declared by the Secretary, in (ii) After initial training, provide requirements of paragraphs (a)(2), (3), accordance with section 1135 of Act, in emergency preparedness training at and (4) of this section. The unified and the provision of care and treatment at an least annually. integrated emergency plan must also be alternate care site identified by (iii) Demonstrate staff knowledge of based on and include the following: emergency management officials. emergency procedures. (i) A documented community-based (c) Communication plan. The PRTF (iv) Maintain documentation of all risk assessment, utilizing an all-hazards must develop and maintain an emergency preparedness training. approach. emergency preparedness (2) Testing. The PRTF must conduct (ii) A documented individual facility- communication plan that complies with exercises to test the emergency plan. based risk assessment for each Federal, State, and local laws and must The PRTF must do the following: separately certified facility within the be reviewed and updated at least (i) Participate in a full-scale exercise health system, utilizing an all-hazards annually. The communication plan that is community-based or when a approach. must include all of the following: community-based exercise is not (5) Include integrated policies and (1) Names and contact information for accessible, an individual, facility-based. procedures that meet the requirements the following: If the PRTF experiences an actual set forth in paragraph (b) of this section, (i) Staff. natural or man-made emergency that a coordinated communication plan and (ii) Entities providing services under requires activation of the emergency training and testing programs that meet arrangement. plan, the PRTF is exempt from engaging the requirements of paragraphs (c) and (iii) Residents’ physicians. in a community-based or individual, (d) of this section, respectively. (iv) Other PRTFs. facility-based full-scale exercise for 1 (v) Volunteers. year following the onset of the actual PART 460—PROGRAMS OF ALL- (2) Contact information for the event. INCLUSIVE CARE FOR THE ELDERLY following: (ii) Conduct an additional exercise (PACE) (i) Federal, State, tribal, regional, and that may include, but is not limited to local emergency preparedness staff. the following: ■ 12. The authority citation for part 460 (ii) Other sources of assistance. (A) A second full-scale exercise that is continues to read as follows: (3) Primary and alternate means for community-based or individual, facility- Authority: Secs: 1102, 1871, 1894(f), and communicating with the PRTF’s staff, based. 1934(f) of the Social Security Act (42 U.S.C. Federal, State, tribal, regional, and local (B) A tabletop exercise that includes 1302, 1395, 1395eee(f), and 1396u–4(f)). emergency management agencies. a group discussion led by a facilitator, (4) A method for sharing information using a narrated, clinically-relevant § 460.72 [Amended] and medical documentation for emergency scenario, and a set of ■ 13. Amend § 460.72 by removing and residents under the PRTF’s care, as problem statements, directed messages, reserving paragraph (c). necessary, with other health care or prepared questions designed to ■ 14. Add § 460.84 to subpart E to read providers to maintain the continuity of challenge an emergency plan. as follows: care. (iii) Analyze the PRTF’s response to (5) A means, in the event of an and maintain documentation of all § 460.84 Emergency preparedness. evacuation, to release resident drills, tabletop exercises, and emergency The Program for the All-Inclusive information as permitted under 45 CFR events and revise the PRTF’s emergency Care for the Elderly (PACE) organization 164.510(b)(1)(ii). plan, as needed. must comply with all applicable (6) A means of providing information (e) Integrated healthcare systems. If a Federal, State, and local emergency about the general condition and location PRTF is part of a healthcare system preparedness requirements. The PACE of residents under the facility’s care as consisting of multiple separately organization must establish and permitted under 45 CFR 164.510(b)(4). certified healthcare facilities that elects maintain an emergency preparedness

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program that meets the requirements of (C) Fire detection, extinguishing, and (c) Communication plan. The PACE this section. The emergency alarm systems. organization must develop and maintain preparedness program must include, but (D) Sewage and waste disposal. an emergency preparedness not be limited to, the following (2) A system to track the location of communication plan that complies with elements: on-duty staff and sheltered participants Federal, State, and local laws and must (a) Emergency plan. The PACE under the PACE center(s) care during be reviewed and updated at least organization must develop and maintain and after an emergency. If on-duty staff annually. The communication plan an emergency preparedness plan that and sheltered participants are relocated must include all of the following: must be reviewed, and updated at least during the emergency, the PACE must (1) Names and contact information for annually. The plan must do the document the specific name and staff; entities providing services under following: location of the receiving facility or other arrangement; participants’ physicians; (1) Be based on and include a location. other PACE organizations; and documented, facility-based and (3) Safe evacuation from the PACE volunteers. community-based risk assessment, center, which includes consideration of (2) Contact information for the utilizing an all-hazards approach. care and treatment needs of evacuees; following: (2) Include strategies for addressing staff responsibilities; transportation; (i) Federal, State, tribal, regional, and emergency events identified by the risk identification of evacuation location(s); local emergency preparedness staff. assessment. and primary and alternate means of (ii) Other sources of assistance. (3) Address participant population, communication with external sources of (3) Primary and alternate means for including, but not limited to, the type of assistance. communicating with the following: services the PACE organization has the (4) The procedures to inform State (i) PACE organization’s staff. ability to provide in an emergency; and and local emergency preparedness (ii) Federal, State, tribal, regional, and continuity of operations, including officials about PACE participants in local emergency management agencies. (4) A method for sharing information delegations of authority and succession need of evacuation from their residences and medical documentation for plans. at any time due to an emergency participants under the organization’s (4) Include a process for cooperation situation based on the participant’s care, as necessary, with other health and collaboration with local, tribal, medical and psychiatric conditions and care providers to maintain the regional, State, and Federal emergency home environment. continuity of care. preparedness officials’ efforts to (5) A means to shelter in place for (5) A means, in the event of an maintain an integrated response during participants, staff, and volunteers who evacuation, to release participant a disaster or emergency situation, remain in the facility. information as permitted under 45 CFR including documentation of the PACE’s (6) A system of medical 164.510(b)(1)(ii). efforts to contact such officials and, documentation that preserves (6) A means of providing information when applicable, of its participation in participant information, protects about the general condition and location organization’s collaborative and confidentiality of participant of participants under the facility’s care cooperative planning efforts. information, and secures and maintains as permitted under 45 CFR (b) Policies and procedures. The the availability of records. 164.510(b)(4). PACE organization must develop and (7) The use of volunteers in an (7) A means of providing information implement emergency preparedness emergency or other emergency staffing about the PACE organization’s needs, policies and procedures, based on the strategies, including the process and and its ability to provide assistance, to emergency plan set forth in paragraph role for integration of State or Federally the authority having jurisdiction, the (a) of this section, risk assessment at designated health care professionals to Incident Command Center, or designee. paragraph (a)(1) of this section, and the address surge needs during an (d) Training and testing. The PACE communication plan at paragraph (c) of emergency. organization must develop and maintain this section. The policies and (8) The development of arrangements an emergency preparedness training and procedures must address management with other PACE organizations, PACE testing program that is based on the of medical and nonmedical centers, or other providers to receive emergency plan set forth in paragraph emergencies, including, but not limited participants in the event of limitations (a) of this section, risk assessment at to: Fire; equipment, power, or water or cessation of operations to maintain paragraph (a)(1) of this section, policies failure; care-related emergencies; and the continuity of services to PACE and procedures at paragraph (b) of this natural disasters likely to threaten the participants. section, and the communication plan at health or safety of the participants, staff, (9) The role of the PACE organization paragraph (c) of this section. The or the public. Policies and procedures under a waiver declared by the training and testing program must be must be reviewed and updated at least Secretary, in accordance with section reviewed and updated at least annually. annually. At a minimum, the policies 1135 of the Act, in the provision of care (1) Training program. The PACE and procedures must address the and treatment at an alternate care site organization must do all of the following: identified by emergency management following: (1) The provision of subsistence needs officials. (i) Initial training in emergency for staff and participants, whether they (10)(i) Emergency equipment, preparedness policies and procedures to evacuate or shelter in place, include, but including easily portable oxygen, all new and existing staff, individuals are not limited to the following: airways, suction, and emergency drugs. providing on-site services under (i) Food, water, and medical supplies. (ii) Staff who know how to use the arrangement, contractors, participants, (ii) Alternate sources of energy to equipment must be on the premises of and volunteers, consistent with their maintain the following: every center at all times and be expected roles. (A) Temperatures to protect immediately available. (ii) Provide emergency preparedness participant health and safety and for the (iii) A documented plan to obtain training at least annually. safe and sanitary storage of provisions. emergency medical assistance from (iii) Demonstrate staff knowledge of (B) Emergency lighting. outside sources when needed. emergency procedures, including

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informing participants of what to do, requirements of paragraphs (a)(2), (3), a disaster or emergency situation, where to go, and whom to contact in and (4) of this section. The unified and including documentation of the case of an emergency. integrated emergency plan must also be hospital’s efforts to contact such (iv) Maintain documentation of all based on and include the following: officials and, when applicable, its training. (i) A documented community-based participation in collaborative and (2) Testing. The PACE organization risk assessment, utilizing an all-hazards cooperative planning efforts. must conduct exercises to test the approach. (b) Policies and procedures. The emergency plan at least annually. The (ii) A documented individual facility- hospital must develop and implement PACE organization must do the based risk assessment for each emergency preparedness policies and following: separately certified facility within the procedures, based on the emergency (i) Participate in a full-scale exercise health system, utilizing an all-hazards plan set forth in paragraph (a) of this that is community-based or when a approach. section, risk assessment at paragraph community-based exercise is not (5) Include integrated policies and (a)(1) of this section, and the accessible, an individual, facility-based. procedures that meet the requirements communication plan at paragraph (c) of If the PACE experiences an actual set forth in paragraph (b) of this section, this section. The policies and natural or man-made emergency that a coordinated communication plan and procedures must be reviewed and requires activation of the emergency training and testing programs that meet updated at least annually. At a plan, the PACE is exempt from engaging the requirements of paragraphs (c) and minimum, the policies and procedures in a community-based or individual, (d) of this section, respectively. must address the following: facility-based full-scale exercise for 1 (1) The provision of subsistence needs year following the onset of the actual PART 482—CONDITIONS OF for staff and patients, whether they event. PARTICIPATION FOR HOSPITALS evacuate or shelter in place, include, but (ii) Conduct an additional exercise are not limited to the following: ■ 15. The authority citation for part 482 that may include, but is not limited to (i) Food, water, medical, and continues to read as follows: the following: pharmaceutical supplies. (A) A second full-scale exercise that is Authority: Secs. 1102, 1871, and 1881 of (ii) Alternate sources of energy to community-based or individual, facility- the Social Security Act (42 U.S.C. 1302, maintain the following: based. 1395hh, and 1395rr), unless otherwise noted. (A) Temperatures to protect patient (B) A tabletop exercise that includes ■ 16. Add § 482.15 to subpart B to read health and safety and for the safe and a group discussion led by a facilitator, as follows: sanitary storage of provisions. using a narrated, clinically-relevant (B) Emergency lighting. emergency scenario, and a set of § 482.15 Condition of participation: (C) Fire detection, extinguishing, and problem statements, directed messages, Emergency preparedness. alarm systems. or prepared questions designed to The hospital must comply with all (D) Sewage and waste disposal. challenge an emergency plan. applicable Federal, State, and local (2) A system to track the location of (iii) Analyze the PACE’s response to emergency preparedness requirements. on-duty staff and sheltered patients in and maintain documentation of all The hospital must develop and maintain the hospital’s care during an emergency. drills, tabletop exercises, and emergency a comprehensive emergency If on-duty staff and sheltered patients events and revise the PACE’s emergency preparedness program that meets the are relocated during the emergency, the plan, as needed. requirements of this section, utilizing an hospital must document the specific (e) Integrated healthcare systems. If a all-hazards approach. The emergency name and location of the receiving PACE is part of a healthcare system preparedness program must include, but facility or other location. consisting of multiple separately not be limited to, the following (3) Safe evacuation from the hospital, certified healthcare facilities that elects elements: which includes consideration of care to have a unified and integrated (a) Emergency plan. The hospital and treatment needs of evacuees; staff emergency preparedness program, the must develop and maintain an responsibilities; transportation; PACE may choose to participate in the emergency preparedness plan that must identification of evacuation location(s); healthcare system’s coordinated be reviewed, and updated at least and primary and alternate means of emergency preparedness program. If annually. The plan must do the communication with external sources of elected, the unified and integrated following: assistance. emergency preparedness program (1) Be based on and include a (4) A means to shelter in place for must— documented, facility-based and patients, staff, and volunteers who (1) Demonstrate that each separately community-based risk assessment, remain in the facility. certified facility within the system utilizing an all-hazards approach. (5) A system of medical actively participated in the development (2) Include strategies for addressing documentation that preserves patient of the unified and integrated emergency emergency events identified by the risk information, protects confidentiality of preparedness program. assessment. patient information, and secures and (2) Be developed and maintained in a (3) Address patient population, maintains the availability of records. manner that takes into account each including, but not limited to, persons at- (6) The use of volunteers in an separately certified facility’s unique risk; the type of services the hospital has emergency and other emergency staffing circumstances, participant populations, the ability to provide in an emergency; strategies, including the process and and services offered. and continuity of operations, including role for integration of State and (3) Demonstrate that each separately delegations of authority and succession Federally designated health care certified facility is capable of actively plans. professionals to address surge needs using the unified and integrated (4) Include a process for cooperation during an emergency. emergency preparedness program and is and collaboration with local, tribal, (7) The development of arrangements in compliance with the program. regional, State, and Federal emergency with other hospitals and other providers (4) Include a unified and integrated preparedness officials’ efforts to to receive patients in the event of emergency plan that meets the maintain an integrated response during limitations or cessation of operations to

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maintain the continuity of services to providing services under arrangement, Facilities Code, NFPA 110, and Life hospital patients. and volunteers, consistent with their Safety Code. (8) The role of the hospital under a expected role. (3) Emergency generator fuel. waiver declared by the Secretary, in (ii) Provide emergency preparedness Hospitals that maintain an onsite fuel accordance with section 1135 of the Act, training at least annually. source to power emergency generators in the provision of care and treatment at (iii) Maintain documentation of the must have a plan for how it will keep an alternate care site identified by training. emergency power systems operational emergency management officials. (iv) Demonstrate staff knowledge of during the emergency, unless it (c) Communication plan. The hospital emergency procedures. evacuates. must develop and maintain an (2) Testing. The hospital must (f) Integrated healthcare systems. If a emergency preparedness conduct exercises to test the emergency hospital is part of a healthcare system communication plan that complies with plan at least annually. The hospital consisting of multiple separately Federal, State, and local laws and must must do all of the following: certified healthcare facilities that elects be reviewed and updated at least (i) Participate in a full-scale exercise to have a unified and integrated annually. The communication plan that is community-based or when a emergency preparedness program, the must include all of the following: community-based exercise is not hospital may choose to participate in (1) Names and contact information for accessible, an individual, facility-based. the healthcare system’s coordinated the following: If the hospital experiences an actual emergency preparedness program. If (i) Staff. natural or man-made emergency that elected, the unified and integrated (ii) Entities providing services under requires activation of the emergency emergency preparedness program arrangement. plan, the hospital is exempt from must— (iii) Patients’ physicians. engaging in a community-based or (1) Demonstrate that each separately (iv) Other hospitals and CAHs individual, facility-based full-scale certified facility within the system (v) Volunteers. exercise for 1 year following the onset actively participated in the development (2) Contact information for the of the actual event. of the unified and integrated emergency following: (ii) Conduct an additional exercise preparedness program. (i) Federal, State, tribal, regional, and that may include, but is not limited to (2) Be developed and maintained in a local emergency preparedness staff. the following: manner that takes into account each (ii) Other sources of assistance. (A) A second full-scale exercise that is separately certified facility’s unique (3) Primary and alternate means for community-based or individual, facility- circumstances, patient populations, and communicating with the following: based. services offered. (i) Hospital’s staff. (B) A tabletop exercise that includes (3) Demonstrate that each separately (ii) Federal, State, tribal, regional, and a group discussion led by a facilitator, certified facility is capable of actively local emergency management agencies. using a narrated, clinically-relevant using the unified and integrated (4) A method for sharing information emergency scenario, and a set of emergency preparedness program and is and medical documentation for patients problem statements, directed messages, in compliance with the program. under the hospital’s care, as necessary, or prepared questions designed to (4) Include a unified and integrated with other health care providers to challenge an emergency plan. emergency plan that meets the maintain the continuity of care. (iii) Analyze the hospital’s response to requirements of paragraphs (a)(2), (3), (5) A means, in the event of an and maintain documentation of all and (4) of this section. The unified and evacuation, to release patient drills, tabletop exercises, and emergency integrated emergency plan must also be information as permitted under 45 CFR events, and revise the hospital’s based on and include the following: 164.510(b)(1)(ii). emergency plan, as needed. (i) A documented community-based (6) A means of providing information (e) Emergency and standby power risk assessment, utilizing an all-hazards about the general condition and location systems. The hospital must implement approach. of patients under the facility’s care as emergency and standby power systems (ii) A documented individual facility- permitted under 45 CFR 164.510(b)(4). based on the emergency plan set forth based risk assessment for each (7) A means of providing information in paragraph (a) of this section and in separately certified facility within the about the hospital’s occupancy, needs, the policies and procedures plan set health system, utilizing an all-hazards and its ability to provide assistance, to forth in paragraphs (b)(1)(i) and (ii) of approach. the authority having jurisdiction, the this section. (5) Include integrated policies and Incident Command Center, or designee. (1) Emergency generator location. The procedures that meet the requirements (d) Training and testing. The hospital generator must be located in accordance set forth in paragraph (b) of this section, must develop and maintain an with the location requirements found in a coordinated communication plan and emergency preparedness training and the Health Care Facilities Code (NFPA training and testing programs that meet testing program that is based on the 99 and Tentative Interim Amendments the requirements of paragraphs (c) and emergency plan set forth in paragraph TIA 12–2, TIA 12–3, TIA 12–4, TIA 12– (d) of this section, respectively. (a) of this section, risk assessment at 5, and TIA 12–6), Life Safety Code (g) Transplant hospitals. If a hospital paragraph (a)(1) of this section, policies (NFPA 101 and Tentative Interim has one or more transplant centers (as and procedures at paragraph (b) of this Amendments TIA 12–1, TIA 12–2, TIA defined in § 482.70)— section, and the communication plan at 12–3, and TIA 12–4), and NFPA 110, (1) A representative from each paragraph (c) of this section. The when a new structure is built or when transplant center must be included in training and testing program must be an existing structure or building is the development and maintenance of reviewed and updated at least annually. renovated. the hospital’s emergency preparedness (1) Training program. The hospital (2) Emergency generator inspection program; and must do all of the following: and testing. The hospital must (2) The hospital must develop and (i) Initial training in emergency implement the emergency power system maintain mutually agreed upon preparedness policies and procedures to inspection, testing, and maintenance protocols that address the duties and all new and existing staff, individuals requirements found in the Health Care responsibilities of the hospital, each

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transplant center, and the OPO for the (a) Unless specified otherwise, the emergency preparedness plan that must DSA where the hospital is situated, conditions of participation at §§ 482.72 be reviewed, and updated at least unless the hospital has been granted a through 482.104 apply to heart, heart- annually. The plan must do all of the waiver to work with another OPO, lung, intestine, kidney, liver, lung, and following: during an emergency. pancreas centers. (1) Be based on and include a (h) The standards incorporated by (b) In addition to meeting the documented, facility-based and reference in this section are approved conditions of participation specified in community-based risk assessment, for incorporation by reference by the §§ 482.72 through 482.104, a transplant utilizing an all-hazards approach, Director of the Office of the Federal center must also meet the conditions of including missing residents. Register in accordance with 5 U.S.C. participation in §§ 482.1 through (2) Include strategies for addressing 552(a) and 1 CFR part 51. You may 482.57, except for § 482.15. emergency events identified by the risk obtain the material from the sources ■ 18. Add § 482.78 to read as follows: assessment. listed below. You may inspect a copy at (3) Address resident population, the CMS Information Resource Center, § 482.78 Condition of participation: including, but not limited to, persons at- 7500 Security Boulevard, Baltimore, MD Emergency preparedness for transplant risk; the type of services the LTC facility or at the National Archives and Records centers. has the ability to provide in an Administration (NARA). For A transplant center must be included emergency; and continuity of information on the availability of this in the emergency preparedness planning operations, including delegations of material at NARA, call 202–741–6030, and the emergency preparedness authority and succession plans. or go to: http://www.archives.gov/ program as set forth in § 482.15 for the (4) Include a process for cooperation federal_register/code_of_federal_ hospital in which it is located. However, and collaboration with local, tribal, regulations/ibr_locations.html. If any a transplant center is not individually regional, State, or Federal emergency changes in this edition of the Code are responsible for the emergency preparedness officials’ efforts to incorporated by reference, CMS will preparedness requirements set forth in maintain an integrated response during publish a document in the Federal § 482.15. a disaster or emergency situation, Register to announce the changes. (a) Standard: Policies and procedures. including documentation of the LTC (1) National Fire Protection A transplant center must have policies facility’s efforts to contact such officials Association, 1 Batterymarch Park, and procedures that address emergency and, when applicable, of its Quincy, MA 02169, www.nfpa.org, preparedness. These policies and participation in collaborative and 1.617.770.3000. procedures must be included in the cooperative planning efforts. (i) NFPA 99, Health Care Facilities hospital’s emergency preparedness (b) Policies and procedures. The LTC Code, 2012 edition, issued August 11, program. facility must develop and implement 2011. (b) Standard: Protocols with hospital emergency preparedness policies and (ii) Technical interim amendment and OPO. A transplant center must procedures, based on the emergency (TIA) 12–2 to NFPA 99, issued August develop and maintain mutually agreed plan set forth in paragraph (a) of this 11, 2011. upon protocols that address the duties section, risk assessment at paragraph (iii) TIA 12–3 to NFPA 99, issued and responsibilities of the transplant (a)(1) of this section, and the August 9, 2012. center, the hospital in which the communication plan at paragraph (c) of (iv) TIA 12–4 to NFPA 99, issued transplant center is operated, and the this section. The policies and March 7, 2013. OPO designated by the Secretary, unless procedures must be reviewed and (v) TIA 12–5 to NFPA 99, issued the hospital has an approved waiver to August 1, 2013. updated at least annually. At a work with another OPO, during an minimum, the policies and procedures (vi) TIA 12–6 to NFPA 99, issued emergency. March 3, 2014. must address the following: (1) The provision of subsistence needs (vii) NFPA 101, Life Safety Code, PART 483—REQUIREMENTS FOR 2012 edition, issued August 11, 2011. for staff and residents, whether they STATES AND LONG TERM CARE evacuate or shelter in place, include, but (viii) TIA 12–1 to NFPA 101, issued FACILITIES August 11, 2011. are not limited to the following: (ix) TIA 12–2 to NFPA 101, issued ■ 19. The authority citation for part 483 (i) Food, water, medical, and October 30, 2012. continues to read as follows: pharmaceutical supplies. (x) TIA 12–3 to NFPA 101, issued (ii) Alternate sources of energy to October 22, 2013. Authority: Secs. 1102, 1128I, 1819, 1871 maintain— (xi) TIA 12–4 to NFPA 101, issued and 1919 of the Social Security Act (42 (A) Temperatures to protect resident U.S.C. 1302, 1320a–7, 1395i, 1395hh and health and safety and for the safe and October 22, 2013. 1396r). (xiii) NFPA 110, Standard for sanitary storage of provisions; Emergency and Standby Power Systems, ■ 20. Add § 483.73 to read as follows: (B) Emergency lighting; 2010 edition, including TIAs to chapter (C) Fire detection, extinguishing, and 7, issued August 6, 2009. § 483.73 Emergency preparedness. alarm systems; and (2) [Reserved] The LTC facility must comply with all (D) Sewage and waste disposal. ■ 17. Revise § 482.68 to read as follows: applicable Federal, State and local (2) A system to track the location of emergency preparedness requirements. on-duty staff and sheltered residents in § 482.68 Special requirement for The LTC facility must establish and the LTC facility’s care during and after transplant centers. maintain an emergency preparedness an emergency. If on-duty staff and A transplant center located within a program that meets the requirements of sheltered residents are relocated during hospital that has a Medicare provider this section. The emergency the emergency, the LTC facility must agreement must meet the conditions of preparedness program must include, but document the specific name and participation specified in §§ 482.72 not be limited to, the following location of the receiving facility or other through 482.104 in order to be granted elements: location. approval from CMS to provide (a) Emergency plan. The LTC facility (3) Safe evacuation from the LTC transplant services. must develop and maintain an facility, which includes consideration of

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care and treatment needs of evacuees; (5) A means, in the event of an (B) A tabletop exercise that includes staff responsibilities; transportation; evacuation, to release resident a group discussion led by a facilitator, identification of evacuation location(s); information as permitted under 45 CFR using a narrated, clinically-relevant and primary and alternate means of 164.510(b)(1)(ii). emergency scenario, and a set of communication with external sources of (6) A means of providing information problem statements, directed messages, assistance. about the general condition and location or prepared questions designed to (4) A means to shelter in place for of residents under the facility’s care as challenge an emergency plan. residents, staff, and volunteers who permitted under 45 CFR 164.510(b)(4). (iii) Analyze the LTC facility’s remain in the LTC facility. (7) A means of providing information response to and maintain (5) A system of medical about the LTC facility’s occupancy, documentation of all drills, tabletop documentation that preserves resident needs, and its ability to provide exercises, and emergency events, and information, protects confidentiality of assistance, to the authority having revise the LTC facility’s emergency resident information, and secures and jurisdiction or the Incident Command plan, as needed. maintains the availability of records. Center, or designee. (e) Emergency and standby power (6) The use of volunteers in an (8) A method for sharing information systems. The LTC facility must emergency or other emergency staffing from the emergency plan that the implement emergency and standby strategies, including the process and facility has determined is appropriate power systems based on the emergency role for integration of State or Federally with residents and their families or plan set forth in paragraph (a) of this designated health care professionals to representatives. section. address surge needs during an (d) Training and testing. The LTC (1) Emergency generator location. The emergency. facility must develop and maintain an generator must be located in accordance (7) The development of arrangements emergency preparedness training and with the location requirements found in with other LTC facilities and other testing program that is based on the the Health Care Facilities Code (NFPA providers to receive residents in the emergency plan set forth in paragraph 99 and Tentative Interim Amendments event of limitations or cessation of (a) of this section, risk assessment at TIA 12–2, TIA 12–3, TIA 12–4, TIA 12– operations to maintain the continuity of paragraph (a)(1) of this section, policies 5, and TIA 12–6), Life Safety Code services to LTC residents. and procedures at paragraph (b) of this (NFPA 101 and Tentative Interim (8) The role of the LTC facility under section, and the communication plan at Amendments TIA 12–1, TIA 12–2, TIA a waiver declared by the Secretary, in paragraph (c) of this section. The 12–3, and TIA 12–4), and NFPA 110, accordance with section 1135 of the Act, training and testing program must be when a new structure is built or when in the provision of care and treatment at reviewed and updated at least annually. an existing structure or building is an alternate care site identified by (1) Training program. The LTC facility renovated. emergency management officials. must do all of the following: (2) Emergency generator inspection (i) Initial training in emergency (c) Communication plan. The LTC and testing. The LTC facility must preparedness policies and procedures to facility must develop and maintain an implement the emergency power system all new and existing staff, individuals emergency preparedness inspection, testing, and maintenance providing services under arrangement, communication plan that complies with requirements found in the Health Care and volunteers, consistent with their Federal, State, and local laws and must Facilities Code, NFPA 110, and Life expected roles. be reviewed and updated at least Safety Code. (ii) Provide emergency preparedness annually. The communication plan (3) Emergency generator fuel. LTC must include all of the following: training at least annually. (iii) Maintain documentation of the facilities that maintain an onsite fuel (1) Names and contact information for source to power emergency generators the following: training. (iv) Demonstrate staff knowledge of must have a plan for how it will keep (i) Staff. emergency power systems operational (ii) Entities providing services under emergency procedures. during the emergency, unless it arrangement. (2) Testing. The LTC facility must evacuates. (iii) Residents’ physicians. conduct exercises to test the emergency (iv) Other LTC facilities. plan at least annually, including (f) Integrated healthcare systems. If a (v) Volunteers. unannounced staff drills using the LTC facility is part of a healthcare (2) Contact information for the emergency procedures. The LTC facility system consisting of multiple separately following: must do the following: certified healthcare facilities that elects (i) Federal, State, tribal, regional, or (i) Participate in a full-scale exercise to have a unified and integrated local emergency preparedness staff. that is community-based or when a emergency preparedness program, the (ii) The State Licensing and community-based exercise is not LTC facility may choose to participate Certification Agency. accessible, an individual, facility-based. in the healthcare system’s coordinated (iii) The Office of the State Long-Term If the LTC facility experiences an actual emergency preparedness program. If Care Ombudsman. natural or man-made emergency that elected, the unified and integrated (iv) Other sources of assistance. requires activation of the emergency emergency preparedness program must (3) Primary and alternate means for plan, the LTC facility is exempt from do all of the following: communicating with the following: engaging in a community-based or (1) Demonstrate that each separately (i) LTC facility’s staff. individual, facility-based full-scale certified facility within the system (ii) Federal, State, tribal, regional, or exercise for 1 year following the onset actively participated in the development local emergency management agencies. of the actual event. of the unified and integrated emergency (4) A method for sharing information (ii) Conduct an additional exercise preparedness program. and medical documentation for that may include, but is not limited to (2) Be developed and maintained in a residents under the LTC facility’s care, the following: manner that takes into account each as necessary, with other health care (A) A second full-scale exercise that is separately certified facility’s unique providers to maintain the continuity of community-based or individual, facility- circumstances, patient populations, and care. based. services offered.

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(3) Demonstrate that each separately (ix) TIA 12–2 to NFPA 101, issued emergency preparedness policies and certified facility is capable of actively October 30, 2012. procedures, based on the emergency using the unified and integrated (x) TIA 12–3 to NFPA 101, issued plan set forth in paragraph (a) of this emergency preparedness program and is October 22, 2013. section, risk assessment at paragraph in compliance with the program. (xi) TIA 12–4 to NFPA 101, issued (a)(1) of this section, and the (4) Include a unified and integrated October 22, 2013. communication plan at paragraph (c) of emergency plan that meets the (xiii) NFPA 110, Standard for this section. The policies and requirements of paragraphs (a)(2), (3), Emergency and Standby Power Systems, procedures must be reviewed and and (4) of this section. The unified and 2010 edition, including TIAs to chapter updated at least annually. At a integrated emergency plan must also be 7, issued August 6, 2009. minimum, the policies and procedures based on and include— (2) [Reserved] must address the following: (i) A documented community-based § 483.75 [Amended] (1) The provision of subsistence needs risk assessment, utilizing an all-hazards for staff and clients, whether they approach. ■ 21. Amend § 483.75 by removing and evacuate or shelter in place, include, but (ii) A documented individual facility- reserving paragraph (m). are not limited to the following: based risk assessment for each § 483.470 [Amended] (i) Food, water, medical, and separately certified facility within the pharmaceutical supplies. ■ health system, utilizing an all-hazards 22. Amend § 483.470 by removing and (ii) Alternate sources of energy to approach. reserving paragraph (h). maintain the following: (5) Include integrated policies and ■ 23. Add § 483.475 to read as follows: (A) Temperatures to protect client procedures that meet the requirements health and safety and for the safe and set forth in paragraph (b) of this section, § 483.475 Condition of participation: Emergency preparedness. sanitary storage of provisions. a coordinated communication plan and (B) Emergency lighting. training and testing programs that meet The Intermediate Care Facility for Individuals with Intellectual Disabilities (C) Fire detection, extinguishing, and the requirements of paragraphs (c) and alarm systems. (d) of this section, respectively. (ICF/IID) must comply with all applicable Federal, State, and local (D) Sewage and waste disposal. (g) The standards incorporated by (2) A system to track the location of reference in this section are approved emergency preparedness requirements. The ICF/IID must establish and on-duty staff and sheltered clients in the for incorporation by reference by the ICF/IID’s care during and after an Director of the Office of the Federal maintain an emergency preparedness program that meets the requirements of emergency. If on-duty staff and Register in accordance with 5 U.S.C. sheltered clients are relocated during 552(a) and 1 CFR part 51. You may this section. The emergency preparedness program must include, but the emergency, the ICF/IID must obtain the material from the sources document the specific name and listed below. You may inspect a copy at not be limited to, the following elements: location of the receiving facility or other the CMS Information Resource Center, location. 7500 Security Boulevard, Baltimore, MD (a) Emergency plan. The ICF/IID must develop and maintain an emergency (3) Safe evacuation from the ICF/IID, or at the National Archives and Records which includes consideration of care Administration (NARA). For preparedness plan that must be reviewed, and updated at least annually. and treatment needs of evacuees; staff information on the availability of this responsibilities; transportation; material at NARA, call 202–741–6030, The plan must do all of the following: (1) Be based on and include a identification of evacuation location(s); or go to: http://www.archives.gov/ and primary and alternate means of federal_register/code_of_federal_ documented, facility-based and _ community-based risk assessment, communication with external sources of regulations/ibr locations.html. If any assistance. changes in this edition of the Code are utilizing an all-hazards approach, (4) A means to shelter in place for incorporated by reference, CMS will including missing clients. clients, staff, and volunteers who publish a document in the Federal (2) Include strategies for addressing remain in the facility. Register to announce the changes. emergency events identified by the risk (5) A system of medical (1) National Fire Protection assessment. documentation that preserves client Association, 1 Batterymarch Park, (3) Address the special needs of its information, protects confidentiality of Quincy, MA 02169, www.nfpa.org, client population, including, but not client information, and secures and 1.617.770.3000. limited to, persons at-risk; the type of (i) NFPA 99, Health Care Facilities services the ICF/IID has the ability to maintains the availability of records. Code 2012 edition, issued August 11, provide in an emergency; and (6) The use of volunteers in an 2011. continuity of operations, including emergency or other emergency staffing (ii) Technical interim amendment delegations of authority and succession strategies, including the process and (TIA) 12–2 to NFPA 99, issued August plans. role for integration of State or Federally 11, 2011. (4) Include a process for cooperation designated health care professionals to (iii) TIA 12–3 to NFPA 99, issued and collaboration with local, tribal, address surge needs during an August 9, 2012. regional, State, and Federal emergency emergency. (iv) TIA 12–4 to NFPA 99, issued preparedness officials’ efforts to (7) The development of arrangements March 7, 2013. maintain an integrated response during with other ICF/IIDs or other providers to (v) TIA 12–5 to NFPA 99, issued a disaster or emergency situation, receive clients in the event of August 1, 2013. including documentation of the ICF/IID limitations or cessation of operations to (vi) TIA 12–6 to NFPA 99, issued efforts to contact such officials and, maintain the continuity of services to March 3, 2014. when applicable, of its participation in ICF/IID clients. (vii) NFPA 101, Life Safety Code, collaborative and cooperative planning (8) The role of the ICF/IID under a 2012 edition, issued August 11, 2011. efforts. waiver declared by the Secretary, in (viii) TIA 12–1 to NFPA 101, issued (b) Policies and procedures. The ICF/ accordance with section 1135 of the Act, August 11, 2011. IID must develop and implement in the provision of care and treatment at

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an alternate care site identified by (1) Training program. The ICF/IID circumstances, patient populations, and emergency management officials. must do all the following: services offered. (c) Communication plan. The ICF/IID (i) Initial training in emergency (3) Demonstrate that each separately must develop and maintain an preparedness policies and procedures to certified facility is capable of actively emergency preparedness all new and existing staff, individuals using the unified and integrated communication plan that complies with providing services under arrangement, emergency preparedness program and is Federal, State, and local laws and must and volunteers, consistent with their in compliance with the program. be reviewed and updated at least expected roles. (4) Include a unified and integrated annually. The communication plan (ii) Provide emergency preparedness emergency plan that meets the must include the following: training at least annually. requirements of paragraphs (a)(2), (3), (1) Names and contact information for (iii) Maintain documentation of the and (4) of this section. The unified and the following: training. integrated emergency plan must also be (i) Staff. (iv) Demonstrate staff knowledge of based on and include all of the (ii) Entities providing services under emergency procedures. following: arrangement. (2) Testing. The ICF/IID must conduct (i) A documented community-based (iii) Clients’ physicians. exercises to test the emergency plan at risk assessment, utilizing an all-hazards (iv) Other ICF/IIDs. least annually. The ICF/IID must do the approach. (v) Volunteers. following: (ii) A documented individual facility- (2) Contact information for the (i) Participate in a full-scale exercise based risk assessment for each following: that is community-based or when a separately certified facility within the (i) Federal, State, tribal, regional, and community-based exercise is not health system, utilizing an all-hazards local emergency preparedness staff. accessible, an individual, facility-based. approach. (ii) Other sources of assistance. (5) Include integrated policies and (iii) The State Licensing and If the ICF/IID experiences an actual natural or man-made emergency that procedures that meet the requirements Certification Agency. set forth in paragraph (b) of this section, (iv) The State Protection and requires activation of the emergency plan, the ICF/IID is exempt from a coordinated communication plan and Advocacy Agency. training and testing programs that meet (3) Primary and alternate means for engaging in a community-based or individual, facility-based full-scale the requirements of paragraphs (c) and communicating with the ICF/IID’s staff, (d) of this section, respectively. Federal, State, tribal, regional, and local exercise for 1 year following the onset emergency management agencies. of the actual event. PART 484—HOME HEALTH SERVICES (4) A method for sharing information (ii) Conduct an additional exercise and medical documentation for clients that may include, but is not limited to ■ 24. The authority citation for part 484 under the ICF/IID’s care, as necessary, the following: continues to read as follows: (A) A second full-scale exercise that is with other health care providers to Authority: Secs. 1102 and 1871 of the maintain the continuity of care. community-based or individual, facility- Social Security Act (42 U.S.C. 1302 and (5) A means, in the event of an based. 1395(hh)) unless otherwise indicated. (B) A tabletop exercise that includes evacuation, to release client information ■ a group discussion led by a facilitator, 25. Add § 484.22 to subpart B to read as permitted under 45 CFR as follows: 164.510(b)(1)(ii). using a narrated, clinically-relevant (6) A means of providing information emergency scenario, and a set of § 484.22 Condition of participation: about the general condition and location problem statements, directed messages, Emergency preparedness. of clients under the facility’s care as or prepared questions designed to The Home Health Agency (HHA) must permitted under 45 CFR 164.510(b)(4). challenge an emergency plan. comply with all applicable Federal, (7) A means of providing information (iii) Analyze the ICF/IID’s response to State, and local emergency preparedness about the ICF/IID’s occupancy, needs, and maintain documentation of all requirements. The HHA must establish and its ability to provide assistance, to drills, tabletop exercises, and emergency and maintain an emergency the authority having jurisdiction, the events, and revise the ICF/IID’s preparedness program that meets the Incident Command Center, or designee. emergency plan, as needed. requirements of this section. The (8) A method for sharing information (e) Integrated healthcare systems. If emergency preparedness program must from the emergency plan that the an ICF/IID is part of a healthcare system include, but not be limited to, the facility has determined is appropriate consisting of multiple separately following elements: with clients and their families or certified healthcare facilities that elects (a) Emergency plan. The HHA must representatives. to have a unified and integrated develop and maintain an emergency (d) Training and testing. The ICF/IID emergency preparedness program, the preparedness plan that must be must develop and maintain an ICF/IID may choose to participate in the reviewed, and updated at least annually. emergency preparedness training and healthcare system’s coordinated The plan must do all of the following: testing program that is based on the emergency preparedness program. If (1) Be based on and include a emergency plan set forth in paragraph elected, the unified and integrated documented, facility-based and (a) of this section, risk assessment at emergency preparedness program must community-based risk assessment, paragraph (a)(1) of this section, policies do all of the following: utilizing an all-hazards approach. and procedures at paragraph (b) of this (1) Demonstrate that each separately (2) Include strategies for addressing section, and the communication plan at certified facility within the system emergency events identified by the risk paragraph (c) of this section. The actively participated in the development assessment. training and testing program must be of the unified and integrated emergency (3) Address patient population, reviewed and updated at least annually. preparedness program. including, but not limited to, the type of The ICF/IID must meet the requirements (2) Be developed and maintained in a services the HHA has the ability to for evacuation drills and training at manner that takes into account each provide in an emergency; and § 483.470(h). separately certified facility’s unique continuity of operations, including

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delegations of authority and succession (1) Names and contact information for facility-based full-scale exercise for 1 plans. the following: year following the onset of the actual (4) Include a process for cooperation (i) Staff. event. and collaboration with local, tribal, (ii) Entities providing services under (ii) Conduct an additional exercise regional, State, and Federal emergency arrangement. that may include, but is not limited to preparedness officials’ efforts to (iii) Patients’ physicians. the following: maintain an integrated response during (iv) Volunteers. (A) A second full-scale exercise that is a disaster or emergency situation, (2) Contact information for the community-based or individual, facility- including documentation of the HHA’s following: based. efforts to contact such officials and, (i) Federal, State, tribal, regional, or (B) A tabletop exercise that includes when applicable, of its participation in local emergency preparedness staff. a group discussion led by a facilitator, collaborative and cooperative planning (ii) Other sources of assistance. using a narrated, clinically-relevant efforts. (3) Primary and alternate means for emergency scenario, and a set of (b) Policies and procedures. The HHA communicating with the HHA’s staff, problem statements, directed messages, must develop and implement Federal, State, tribal, regional, and local or prepared questions designed to emergency preparedness policies and emergency management agencies. challenge an emergency plan. (4) A method for sharing information procedures, based on the emergency (iii) Analyze the HHA’s response to and medical documentation for patients plan set forth in paragraph (a) of this and maintain documentation of all under the HHA’s care, as necessary, section, risk assessment at paragraph drills, tabletop exercises, and emergency with other health care providers to (a)(1) of this section, and the events, and revise the HHA’s emergency maintain the continuity of care. communication plan at paragraph (c) of plan, as needed. (5) A means of providing information this section. The policies and (e) Integrated healthcare systems. If a about the general condition and location procedures must be reviewed and HHA is part of a healthcare system of patients under the facility’s care as updated at least annually. At a consisting of multiple separately minimum, the policies and procedures permitted under 45 CFR 164.510(b)(4). (6) A means of providing information certified healthcare facilities that elects must address the following: to have a unified and integrated (1) The plans for the HHA’s patients about the HHA’s needs, and its ability emergency preparedness program, the during a natural or man-made disaster. to provide assistance, to the authority HHA may choose to participate in the Individual plans for each patient must having jurisdiction, the Incident healthcare system’s coordinated be included as part of the Command Center, or designee. emergency preparedness program. If comprehensive patient assessment, (d) Training and testing. The HHA elected, the unified and integrated which must be conducted according to must develop and maintain an emergency preparedness program must the provisions at § 484.55. emergency preparedness training and (2) The procedures to inform State testing program that is based on the do all of the following: and local emergency preparedness emergency plan set forth in paragraph (1) Demonstrate that each separately officials about HHA patients in need of (a) of this section, risk assessment at certified facility within the system evacuation from their residences at any paragraph (a)(1) of this section, policies actively participated in the development time due to an emergency situation and procedures at paragraph (b) of this of the unified and integrated emergency based on the patient’s medical and section, and the communication plan at preparedness program. psychiatric condition and home paragraph (c) of this section. The (2) Be developed and maintained in a environment. training and testing program must be manner that takes into account each (3) The procedures to follow up with reviewed and updated at least annually. separately certified facility’s unique on-duty staff and patients to determine (1) Training program. The HHA must circumstances, patient populations, and services that are needed, in the event do all of the following: services offered. that there is an interruption in services (i) Initial training in emergency (3) Demonstrate that each separately during or due to an emergency. The preparedness policies and procedures to certified facility is capable of actively HHA must inform State and local all new and existing staff, individuals using the unified and integrated officials of any on-duty staff or patients providing services under arrangement, emergency preparedness program and is that they are unable to contact. and volunteers, consistent with their in compliance with the program. (4) A system of medical expected roles. (4) Include a unified and integrated documentation that preserves patient (ii) Provide emergency preparedness emergency plan that meets the information, protects confidentiality of training at least annually. requirements of paragraphs (a)(2), (3), patient information, and secures and (iii) Maintain documentation of the and (4) of this section. The unified and maintains the availability of records. training. integrated emergency plan must also be (5) The use of volunteers in an (ii) Demonstrate staff knowledge of based on and include all of the emergency or other emergency staffing emergency procedures. following: strategies, including the process and (2) Testing. The HHA must conduct (i) A documented community-based role for integration of State or Federally exercises to test the emergency plan at risk assessment, utilizing an all-hazards designated health care professionals to least annually. The HHA must do the approach. address surge needs during an following: (ii) A documented individual facility- emergency. (i) Participate in a full-scale exercise based risk assessment for each (c) Communication plan. The HHA that is community-based or when a separately certified facility within the must develop and maintain an community-based exercise is not health system, utilizing an all-hazards emergency preparedness accessible, an individual, facility-based. approach. communication plan that complies with If the HHA experiences an actual (5) Include integrated policies and Federal, State, and local laws and must natural or man-made emergency that procedures that meet the requirements be reviewed and updated at least requires activation of the emergency set forth in paragraph (b) of this section, annually. The communication plan plan, the HHA is exempt from engaging a coordinated communication plan and must include all of the following: in a community-based or individual, training and testing programs that meet

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the requirements of paragraphs (c) and (a)(1) of this section, and the paragraph (c) of this section. The (d) of this section, respectively. communication plan at paragraph (c) of training and testing program must be this section. The policies and reviewed and updated at least annually. PART 485—CONDITIONS OF procedures must be reviewed and (1) Training program. The CORF must PARTICIPATION: SPECIALIZED updated at least annually. At a do all of the following: PROVIDERS minimum, the policies and procedures (i) Provide initial training in emergency preparedness policies and ■ must address the following: 26. The authority citation for part 485 (1) Safe evacuation from the CORF, procedures to all new and existing staff, continues to read as follows: which includes staff responsibilities, individuals providing services under Authority: Secs. 1102 and 1871 of the and needs of the patients. arrangement, and volunteers, consistent Social Security Act (42 U.S.C. 1302 and (2) A means to shelter in place for with their expected roles. 1395(hh)). patients, staff, and volunteers who (ii) Provide emergency preparedness training at least annually. § 485.64 [Removed and Reserved] remain in the facility. (3) A system of medical (iii) Maintain documentation of the ■ 27. Remove and reserve § 485.64. documentation that preserves patient training. ■ 28. Add § 485.68 to read as follows: information, protects confidentiality of (iv) Demonstrate staff knowledge of patient information, and secures and emergency procedures. All new § 485.68 Condition of participation: personnel must be oriented and Emergency preparedness. maintains the availability of records. (4) The use of volunteers in an assigned specific responsibilities The Comprehensive Outpatient emergency and other emergency staffing regarding the CORF’s emergency plan Rehabilitation Facility (CORF) must strategies, including the process and within 2 weeks of their first workday. comply with all applicable Federal, role for integration of State or Federally The training program must include State, and local emergency preparedness designated health care professionals to instruction in the location and use of requirements. The CORF must establish address surge needs during an alarm systems and signals and and maintain an emergency emergency. firefighting equipment. preparedness program that meets the (c) Communication plan. The CORF (2) Testing. The CORF must conduct requirements of this section. The must develop and maintain an exercises to test the emergency plan at emergency preparedness program must emergency preparedness least annually. The CORF must do the include, but not be limited to, the communication plan that complies with following: following elements: Federal, State, and local laws and must (i) Participate in a full-scale exercise (a) Emergency plan. The CORF must be reviewed and updated at least that is community-based or when a develop and maintain an emergency annually. The communication plan community-based exercise is not preparedness plan that must be must include all of the following: accessible, an individual, facility-based. reviewed and updated at least annually. (1) Names and contact information for If the CORF experiences an actual The plan must do all of the following: the following: natural or man-made emergency that (1) Be based on and include a (i) Staff. requires activation of the emergency documented, facility-based and (ii) Entities providing services under plan, the CORF is exempt from engaging community-based risk assessment, arrangement. in a community-based or individual, utilizing an all-hazards approach. (iii) Patients’ physicians. facility-based full-scale exercise for 1 (2) Include strategies for addressing (iv) Other CORFs. year following the onset of the actual emergency events identified by the risk (v) Volunteers. event. assessment. (2) Contact information for the (ii) Conduct an additional exercise (3) Address patient population, following: that may include, but is not limited to including, but not limited to, the type of (i) Federal, State, tribal, regional and the following: services the CORF has the ability to local emergency preparedness staff. (A) A second full-scale exercise that is provide in an emergency; and (ii) Other sources of assistance. community-based or individual, facility- continuity of operations, including (3) Primary and alternate means for based. delegations of authority and succession communicating with the CORF’s staff, (B) A tabletop exercise that includes plans. Federal, State, tribal, regional, and local a group discussion led by a facilitator, (4) Include a process for cooperation emergency management agencies. using a narrated, clinically-relevant and collaboration with local, tribal, (4) A method for sharing information emergency scenario, and a set of regional, State, and Federal emergency and medical documentation for patients problem statements, directed messages, preparedness officials’ efforts to under the CORF’s care, as necessary, or prepared questions designed to maintain an integrated response during with other health care providers to challenge an emergency plan. a disaster or emergency situation, maintain the continuity of care. (iii) Analyze the CORF’s response to including documentation of the CORF’s (5) A means of providing information and maintain documentation of all efforts to contact such officials and, about the CORF’s needs, and its ability drills, tabletop exercises, and emergency when applicable, of its participation in to provide assistance, to the authority events, and revise the CORF’s collaborative and cooperative planning having jurisdiction or the Incident emergency plan, as needed. efforts; Command Center, or designee. (e) Integrated healthcare systems. If a (5) Be developed and maintained with (d) Training and testing. The CORF CORF is part of a healthcare system assistance from fire, safety, and other must develop and maintain an consisting of multiple separately appropriate experts. emergency preparedness training and certified healthcare facilities that elects (b) Policies and procedures. The testing program that is based on the to have a unified and integrated CORF must develop and implement emergency plan set forth in paragraph emergency preparedness program, the emergency preparedness policies and (a) of this section, risk assessment at CORF may choose to participate in the procedures, based on the emergency paragraph (a)(1) of this section, policies healthcare system’s coordinated plan set forth in paragraph (a) of this and procedures at paragraph (b) of this emergency preparedness program. If section, risk assessment at paragraph section, and the communication plan at elected, the unified and integrated

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emergency preparedness program must (2) Include strategies for addressing (5) A system of medical do all of the following: emergency events identified by the risk documentation that preserves patient (1) Demonstrate that each separately assessment. information, protects confidentiality of certified facility within the system (3) Address patient population, patient information, and secures and actively participated in the development including, but not limited to, persons at- maintains the availability of records. of the unified and integrated emergency risk; the type of services the CAH has (6) The use of volunteers in an preparedness program. the ability to provide in an emergency; emergency or other emergency staffing (2) Be developed and maintained in a and continuity of operations, including strategies, including the process and manner that takes into account each delegations of authority and succession role for integration of State or Federally separately certified facility’s unique plans. designated health care professionals to circumstances, patient populations, and (4) Include a process for cooperation address surge needs during an services offered. and collaboration with local, tribal, emergency. (7) The development of arrangements (3) Demonstrate that each separately regional, State, and Federal emergency preparedness officials’ efforts to with other CAHs or other providers to certified facility is capable of actively receive patients in the event of using the unified and integrated maintain an integrated response during a disaster or emergency situation, limitations or cessation of operations to emergency preparedness program and is maintain the continuity of services to in compliance with the program. including documentation of the CAH’s efforts to contact such officials and, CAH patients. (4) Include a unified and integrated (8) The role of the CAH under a emergency plan that meets the when applicable, of its participation in collaborative and cooperative planning waiver declared by the Secretary, in requirements of paragraphs (a)(2), (3), accordance with section 1135 of the Act, and (4) of this section. The unified and efforts. (b) Policies and procedures. The CAH in the provision of care and treatment at integrated emergency plan must also be an alternate care site identified by based on and include the following: must develop and implement emergency preparedness policies and emergency management officials. (i) A documented community–based (c) Communication plan. The CAH procedures, based on the emergency risk assessment, utilizing an all-hazards must develop and maintain an plan set forth in paragraph (a) of this approach. emergency preparedness section, risk assessment at paragraph communication plan that complies with (ii) A documented individual facility- (a)(1) of this section, and the Federal, State, and local laws and must based risk assessment for each communication plan at paragraph (c) of be reviewed and updated at least separately certified facility within the this section. The policies and annually. The communication plan health system, utilizing an all-hazards procedures must be reviewed and must include all of the following: approach. updated at least annually. At a (5) Include integrated policies and (1) Names and contact information for minimum, the policies and procedures the following: procedures that meet the requirements must address the following: set forth in paragraph (b) of this section, (i) Staff. (1) The provision of subsistence needs (ii) Entities providing services under a coordinated communication plan and for staff and patients, whether they arrangement. training and testing programs that meet evacuate or shelter in place, include, but (iii) Patients’ physicians. the requirements of paragraphs (c) and are not limited to— (iv) Other CAHs and hospitals. (d) of this section, respectively. (i) Food, water, medical, and (v) Volunteers. § 485.623 [Amended] pharmaceutical supplies; (2) Contact information for the (ii) Alternate sources of energy to following: ■ 29. Amend § 485.623 by removing maintain: (i) Federal, State, tribal, regional, and paragraph (c) and redesignating (A) Temperatures to protect patient local emergency preparedness staff. paragraphs (d) through (f) as paragraphs health and safety and for the safe and (ii) Other sources of assistance. (c) through (e). sanitary storage of provisions; (3) Primary and alternate means for ■ 30. Adding § 485.625 to subpart F to (B) Emergency lighting; communicating with the following: (i) CAH’s staff. read as follows: (C) Fire detection, extinguishing, and (ii) Federal, State, tribal, regional, and alarm systems; and local emergency management agencies. § 485.625 Condition of participation: (D) Sewage and waste disposal. Emergency preparedness. (4) A method for sharing information (2) A system to track the location of and medical documentation for patients The CAH must comply with all on-duty staff and sheltered patients in under the CAH’s care, as necessary, applicable Federal, State, and local the CAH’s care during an emergency. If with other health care providers to emergency preparedness requirements. on-duty staff and sheltered patients are maintain the continuity of care. The CAH must develop and maintain a relocated during the emergency, the (5) A means, in the event of an comprehensive emergency preparedness CAH must document the specific name evacuation, to release patient program, utilizing an all-hazards and location of the receiving facility or information as permitted under 45 CFR approach. The emergency preparedness other location. 164.510(b)(1)(ii). plan must include, but not be limited to, (3) Safe evacuation from the CAH, (6) A means of providing information the following elements: which includes consideration of care about the general condition and location (a) Emergency plan. The CAH must and treatment needs of evacuees; staff of patients under the facility’s care as develop and maintain an emergency responsibilities; transportation; permitted under 45 CFR 164.510(b)(4). preparedness plan that must be identification of evacuation location(s); (7) A means of providing information reviewed and updated at least annually. and primary and alternate means of about the CAH’s occupancy, needs, and The plan must do all of the following: communication with external sources of its ability to provide assistance, to the (1) Be based on and include a assistance. authority having jurisdiction or the documented, facility-based and (4) A means to shelter in place for Incident Command Center, or designee. community-based risk assessment, patients, staff, and volunteers who (d) Training and testing. The CAH utilizing an all-hazards approach. remain in the facility. must develop and maintain an

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emergency preparedness training and (1) Emergency generator location. The a coordinated communication plan and testing program that is based on the generator must be located in accordance training and testing programs that meet emergency plan set forth in paragraph with the location requirements found in the requirements of paragraphs (c) and (a) of this section, risk assessment at the Health Care Facilities Code (NFPA (d) of this section, respectively. paragraph (a)(1) of this section, policies 99 and Tentative Interim Amendments (g) The standards incorporated by and procedures at paragraph (b) of this TIA 12–2, TIA 12–3, TIA 12–4, TIA 12– reference in this section are approved section, and the communication plan at 5, and TIA 12–6), Life Safety Code for incorporation by reference by the paragraph (c) of this section. The (NFPA 101 and Tentative Interim Director of the Office of the Federal training and testing program must be Amendments TIA 12–1, TIA 12–2, TIA Register in accordance with 5 U.S.C. reviewed and updated at least annually. 12–3, and TIA 12–4), and NFPA 110, 552(a) and 1 CFR part 51. You may (1) Training program. The CAH must when a new structure is built or when obtain the material from the sources do all of the following: an existing structure or building is listed below. You may inspect a copy at (i) Initial training in emergency renovated. the CMS Information Resource Center, preparedness policies and procedures, (2) Emergency generator inspection 7500 Security Boulevard, Baltimore, MD including prompt reporting and and testing. The CAH must implement or at the National Archives and Records extinguishing of fires, protection, and emergency power system inspection and Administration (NARA). For where necessary, evacuation of patients, testing requirements found in the Health information on the availability of this personnel, and guests, fire prevention, Care Facilities Code, NFPA 110, and the material at NARA, call 202–741–6030, and cooperation with firefighting and Life Safety Code. or go to: http://www.archives.gov/ disaster authorities, to all new and (3) Emergency generator fuel. CAHs federal_register/code_of_federal_ existing staff, individuals providing that maintain an onsite fuel source to regulations/ibr_locations.html. If any services under arrangement, and power emergency generators must have changes in this edition of the Code are volunteers, consistent with their a plan for how it will keep emergency incorporated by reference, CMS will expected roles. power systems operational during the publish a document in the Federal (ii) Provide emergency preparedness emergency, unless it evacuates. Register to announce the changes. training at least annually. (f) Integrated healthcare systems. If a (1) National Fire Protection (iii) Maintain documentation of the CAH is part of a healthcare system Association, 1 Batterymarch Park, training. consisting of multiple separately Quincy, MA 02169, www.nfpa.org, (iv) Demonstrate staff knowledge of certified healthcare facilities that elects 1.617.770.3000. emergency procedures. to have a unified and integrated (i) NFPA 99, Health Care Facilities (2) Testing. The CAH must conduct emergency preparedness program, the Code, 2012 edition, issued August 11, exercises to test the emergency plan at CAH may choose to participate in the 2011. least annually. The CAH must do the healthcare system’s coordinated (ii) Technical interim amendment following: emergency preparedness program. If (TIA) 12–2 to NFPA 99, issued August (i) Participate in a full-scale exercise elected, the unified and integrated 11, 2011. that is community-based or when a emergency preparedness program must (iii) TIA 12–3 to NFPA 99, issued community-based exercise is not do all of the following: August 9, 2012. accessible, an individual, facility-based (1) Demonstrate that each separately (iv) TIA 12–4 to NFPA 99, issued exercise. If the CAH experiences an certified facility within the system March 7, 2013. actual natural or man-made emergency actively participated in the development (v) TIA 12–5 to NFPA 99, issued that requires activation of the of the unified and integrated emergency August 1, 2013. emergency plan, the CAH is exempt preparedness program. (vi) TIA 12–6 to NFPA 99, issued from engaging in a community-based or (2) Be developed and maintained in a March 3, 2014. individual, facility-based full-scale manner that takes into account each (vii) NFPA 101, Life Safety Code, exercise for 1 year following the onset separately certified facility’s unique 2012 edition, issued August 11, 2011. of the actual event. circumstances, patient populations, and (viii) TIA 12–1 to NFPA 101, issued (ii) Conduct an additional exercise services offered. August 11, 2011. that may include, but is not limited to (3) Demonstrate that each separately (ix) TIA 12–2 to NFPA 101, issued the following: certified facility is capable of actively October 30, 2012. (A) A second full-scale exercise that is using the unified and integrated (x) TIA 12–3 to NFPA 101, issued community-based or individual, facility- emergency preparedness program and is October 22, 2013. based. in compliance with the program. (xi) TIA 12–4 to NFPA 101, issued (B) A tabletop exercise that includes (4) Include a unified and integrated October 22, 2013. a group discussion led by a facilitator, emergency plan that meets the (xiii) NFPA 110, Standard for using a narrated, clinically-relevant requirements of paragraphs (a)(2), (3), Emergency and Standby Power Systems, emergency scenario, and a set of and (4) of this section. The unified and 2010 edition, including TIAs to chapter problem statements, directed messages, integrated emergency plan must also be 7, issued August 6, 2009. or prepared questions designed to based on and include— (2) [Reserved] challenge an emergency plan. (i) A documented community–based ■ 31. Revise § 485.727 to read as (iii) Analyze the CAH’s response to risk assessment, utilizing an all-hazards follows: and maintain documentation of all approach. drills, tabletop exercises, and emergency (ii) A documented individual facility- § 485.727 Condition of participation: events, and revise the CAH’s emergency based risk assessment for each Emergency preparedness. plan, as needed. separately certified facility within the The Clinics, Rehabilitation Agencies, (e) Emergency and standby power health system, utilizing an all-hazards and Public Health Agencies as Providers systems. The CAH must implement approach. of Outpatient Physical Therapy and emergency and standby power systems (5) Include integrated policies and Speech-Language Pathology Services based on the emergency plan set forth procedures that meet the requirements (‘‘Organizations’’) must comply with all in paragraph (a) of this section. set forth in paragraph (b) of this section, applicable Federal, State, and local

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emergency preparedness requirements. Federally designated health care plan at least annually. The The Organizations must establish and professionals to address surge needs Organizations must do the following: maintain an emergency preparedness during an emergency. (i) Participate in a full-scale exercise program that meets the requirements of (c) Communication plan. The that is community-based or when a this section. The emergency Organizations must develop and community-based exercise is not preparedness program must include, but maintain an emergency preparedness accessible, an individual, facility-based. not be limited to, the following communication plan that complies with If the Organizations experience an elements: Federal, State, and local laws and must actual natural or man-made emergency (a) Emergency plan. The be reviewed and updated at least that requires activation of the Organizations must develop and annually. The communication plan emergency plan, the organization is maintain an emergency preparedness must include all of the following: exempt from engaging in a community- plan that must be reviewed and updated (1) Names and contact information for based or individual, facility-based full- at least annually. The plan must do all the following: scale exercise for 1 year following the of the following: (i) Staff. onset of the actual event. (1) Be based on and include a (ii) Entities providing services under (ii) Conduct an additional exercise documented, facility-based and arrangement. that may include, but is not limited to community-based risk assessment, (iii) Patients’ physicians. the following: utilizing an all-hazards approach. (iv) Other Organizations. (A) A second full-scale exercise that is (2) Include strategies for addressing (v) Volunteers. community-based or individual, facility- (2) Contact information for the emergency events identified by the risk based. following: (B) A tabletop exercise that includes assessment. (i) Federal, state, tribal, regional and (3) Address patient population, a group discussion led by a facilitator, local emergency preparedness staff. using a narrated, clinically-relevant including, but not limited to, the type of (ii) Other sources of assistance. services the Organizations have the (3) Primary and alternate means for emergency scenario, and a set of ability to provide in an emergency; and communicating with the following: problem statements, directed messages, continuity of operations, including (i) Organizations’ staff. or prepared questions designed to delegations of authority and succession (ii) Federal, state, tribal, regional, and challenge an emergency plan. plans. local emergency management agencies. (iii) Analyze the Organization’s (4) Address the location and use of (4) A method for sharing information response to and maintain alarm systems and signals; and methods and medical documentation for patients documentation of all drills, tabletop of containing fire. under the Organizations’ care, as exercises, and emergency events, and (5) Include a process for cooperation necessary, with other health care revise their emergency plan, as needed. and collaboration with local, tribal, providers to maintain the continuity of (e) Integrated healthcare systems. If regional, State, and Federal emergency care. the Organizations are part of a preparedness officials’ efforts to (5) A means of providing information healthcare system consisting of multiple maintain an integrated response during about the Organizations’ needs, and separately certified healthcare facilities a disaster or emergency situation. their ability to provide assistance, to the that elects to have a unified and (6) Be developed and maintained with authority having jurisdiction or the integrated emergency preparedness assistance from fire, safety, and other Incident Command Center, or designee. program, the Organizations may choose appropriate experts. (d) Training and testing. The to participate in the healthcare system’s (b) Policies and procedures. The Organizations must develop and coordinated emergency preparedness Organizations must develop and maintain an emergency preparedness program. If elected, the unified and implement emergency preparedness training and testing program that is integrated emergency preparedness policies and procedures, based on the based on the emergency plan set forth program must do all of the following: emergency plan set forth in paragraph in paragraph (a) of this section, risk (1) Demonstrate that each separately (a) of this section, risk assessment at assessment at paragraph (a)(1) of this certified facility within the system paragraph (a)(1) of this section, and the section, policies and procedures at actively participated in the development communication plan at paragraph (c) of paragraph (b) of this section, and the of the unified and integrated emergency this section. The policies and communication plan at paragraph (c) of preparedness program. procedures must be reviewed and this section. The training and testing (2) Be developed and maintained in a updated at least annually. At a program must be reviewed and updated manner that takes into account each minimum, the policies and procedures at least annually. separately certified facility’s unique must address the following: (1) Training program. The circumstances, patient populations, and (1) Safe evacuation from the Organizations must do all of the services offered. Organizations, which includes staff following: (3) Demonstrate that each separately responsibilities, and needs of the (i) Initial training in emergency certified facility is capable of actively patients. preparedness policies and procedures to using the unified and integrated (2) A means to shelter in place for all new and existing staff, individuals emergency preparedness program and is patients, staff, and volunteers who providing services under arrangement, in compliance. remain in the facility. and volunteers, consistent with their (4) Include a unified and integrated (3) A system of medical expected roles. emergency plan that meets the documentation that preserves patient (ii) Provide emergency preparedness requirements of paragraphs (a)(2), (3), information, protects confidentiality of training at least annually. and (4) of this section. The unified and patient information, and secures and (iii) Maintain documentation of the integrated emergency plan must also be maintains the availability of records. training. based on and include all of the (4) The use of volunteers in an (iv) Demonstrate staff knowledge of following: emergency or other emergency staffing emergency procedures. (i) A documented community-based strategies, including the process and (2) Testing. The Organizations must risk assessment, utilizing an all-hazards role for integration of State and conduct exercises to test the emergency approach.

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(ii) A documented individual facility- (1) A system to track the location of (i) CMHC’s staff. based risk assessment for each on-duty staff and sheltered clients in the (ii) Federal, State, tribal, regional, and separately certified facility within the CMHC’s care during and after an local emergency management agencies. health system, utilizing an all-hazards emergency. If on-duty staff and (4) A method for sharing information approach. sheltered clients are relocated during and medical documentation for clients (5) Include integrated policies and the emergency, the CMHC must under the CMHC’s care, as necessary, procedures that meet the requirements document the specific name and with other health care providers to set forth in paragraph (b) of this section, location of the receiving facility or other maintain the continuity of care. a coordinated communication plan and location. (5) A means, in the event of an training and testing programs that meet (2) Safe evacuation from the CMHC, evacuation, to release client information the requirements of paragraphs (c) and which includes consideration of care as permitted under 45 CFR (d) of this section, respectively. and treatment needs of evacuees; staff 164.510(b)(1)(ii). ■ 32. Add § 485.920 to read as follows: responsibilities; transportation; (6) A means of providing information identification of evacuation location(s); about the general condition and location § 485.920 Condition of participation: and primary and alternate means of of clients under the facility’s care as Emergency preparedness. communication with external sources of permitted under 45 CFR 164.510(b)(4). The Community Mental Health Center assistance. (7) A means of providing information (CMHC) must comply with all (3) A means to shelter in place for about the CMHC’s needs, and its ability applicable Federal, State, and local clients, staff, and volunteers who to provide assistance, to the authority emergency preparedness requirements. remain in the facility. having jurisdiction or the Incident The CMHC must establish and maintain (4) A system of medical Command Center, or designee. an emergency preparedness program documentation that preserves client (d) Training and testing. The CMHC that meets the requirements of this information, protects confidentiality of must develop and maintain an section. The emergency preparedness client information, and secures and emergency preparedness training and program must include, but not be maintains the availability of records. testing program that is based on the limited to, the following elements: (5) The use of volunteers in an emergency plan set forth in paragraph (a) Emergency plan. The CMHC must emergency or other emergency staffing (a) of this section, risk assessment at develop and maintain an emergency strategies, including the process and paragraph (a)(1) of this section, policies preparedness plan that must be role for integration of state or Federally and procedures at paragraph (b) of this reviewed, and updated at least annually. designated health care professionals to section, and the communication plan at The plan must do all of the following: address surge needs during an paragraph (c) of this section. The (1) Be based on and include a emergency. training and testing program must be documented, facility-based and (6) The development of arrangements reviewed and updated at least annually. community-based risk assessment, with other CMHCs or other providers to (1) Training. The CMHC must provide utilizing an all-hazards approach. receive clients in the event of initial training in emergency (2) Include strategies for addressing limitations or cessation of operations to preparedness policies and procedures to emergency events identified by the risk maintain the continuity of services to all new and existing staff, individuals assessment. CMHC clients. providing services under arrangement, (3) Address client population, (7) The role of the CMHC under a and volunteers, consistent with their including, but not limited to, the type of waiver declared by the Secretary of expected roles, and maintain services the CMHC has the ability to Health and Human Services, in documentation of the training. The provide in an emergency; and accordance with section 1135 of the CMHC must demonstrate staff continuity of operations, including Social Security Act, in the provision of knowledge of emergency procedures. delegations of authority and succession care and treatment at an alternate care Thereafter, the CMHC must provide plans. site identified by emergency emergency preparedness training at (4) Include a process for cooperation management officials. least annually. and collaboration with local, tribal, (c) Communication plan. The CMHC (2) Testing. The CMHC must conduct regional, State, and Federal emergency must develop and maintain an exercises to test the emergency plan at preparedness officials’ efforts to emergency preparedness least annually. The CMHC must: maintain an integrated response during communication plan that complies with (i) Participate in a full-scale exercise a disaster or emergency situation, Federal, State, and local laws and must that is community-based or when a including documentation of the CMHC’s be reviewed and updated at least community-based exercise is not efforts to contact such officials and, annually. The communication plan accessible, an individual, facility-based. when applicable, of its participation in must include all of the following: If the CMHC experiences an actual collaborative and cooperative planning (1) Names and contact information for natural or man-made emergency that efforts. the following: requires activation of the emergency (b) Policies and procedures. The (i) Staff. plan, the CMHC is exempt from CMHC must develop and implement (ii) Entities providing services under engaging in a community-based or emergency preparedness policies and arrangement. individual, facility-based full-scale procedures, based on the emergency (iii) Clients’ physicians. exercise for 1 year following the onset plan set forth in paragraph (a) of this (iv) Other CMHCs. of the actual event. section, risk assessment at paragraph (v) Volunteers. (ii) Conduct an additional exercise (a)(1) of this section, and the (2) Contact information for the that may include, but is not limited to communication plan at paragraph (c) of following: the following: this section. The policies and (i) Federal, State, tribal, regional, and (A) A second full-scale exercise that is procedures must be reviewed and local emergency preparedness staff. community-based or individual, facility- updated at least annually. At a (ii) Other sources of assistance. based. minimum, the policies and procedures (3) Primary and alternate means for (B) A tabletop exercise that includes must address the following: communicating with the following: a group discussion led by a facilitator,

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using a narrated, clinically-relevant 1320b–8, and 1395hh) and section 371 of the confidentiality of potential and actual emergency scenario, and a set of Public Health Service Act (42 U.S.C 273). donor information, and secures and problem statements, directed messages, ■ 34. Add § 486.360 to read as follows: maintains the availability of records. or prepared questions designed to (c) Communication plan. The OPO § 486.360 Condition for Coverage: must develop and maintain an challenge an emergency plan. Emergency preparedness. (iii) Analyze the CMHC’s response to emergency preparedness and maintain documentation of all The Organ Procurement Organization communication plan that complies with drills, tabletop exercises, and emergency (OPO) must comply with all applicable Federal, State, and local laws and must events, and revise the CMHC’s Federal, State, and local emergency be reviewed and updated at least emergency plan, as needed. preparedness requirements. The OPO annually. The communication plan (e) Integrated healthcare systems. If a must establish and maintain an must include all of the following: CMHC is part of a healthcare system emergency preparedness program that (1) Names and contact information for consisting of multiple separately meets the requirements of this section. the following: certified healthcare facilities that elects The emergency preparedness program (i) Staff. to have a unified and integrated must include, but not be limited to, the (ii) Entities providing services under emergency preparedness program, the following elements: arrangement. CMHC may choose to participate in the (a) Emergency plan. The OPO must (iii) Volunteers. healthcare system’s coordinated develop and maintain an emergency (iv) Other OPOs. (v) Transplant and donor hospitals in emergency preparedness program. If preparedness plan that must be the OPO’s Donation Service Area (DSA). elected, the unified and integrated reviewed and updated at least annually. The plan must do all of the following: (2) Contact information for the emergency preparedness program must following: do all of the following: (1) Be based on and include a documented, facility-based and (i) Federal, State, tribal, regional, and (1) Demonstrate that each separately local emergency preparedness staff. certified facility within the system community-based risk assessment, utilizing an all-hazards approach. (ii) Other sources of assistance. actively participated in the development (3) Primary and alternate means for of the unified and integrated emergency (2) Include strategies for addressing emergency events identified by the risk communicating with the following: preparedness program. (i) OPO’s staff. assessment. (2) Be developed and maintained in a (ii) Federal, State, tribal, regional, and (3) Address the type of hospitals with manner that takes into account each local emergency management agencies. separately certified facility’s unique which the OPO has agreements; the type (d) Training and testing. The OPO circumstances, patient populations, and of services the OPO has the capacity to must develop and maintain an services offered. provide in an emergency; and emergency preparedness training and (3) Demonstrate that each separately continuity of operations, including testing program that is based on the certified facility is capable of actively delegations of authority and succession emergency plan set forth in paragraph using the unified and integrated plans. (a) of this section, risk assessment at (4) Include a process for cooperation emergency preparedness program and is paragraph (a)(1) of this section, policies and collaboration with local, tribal, in compliance. and procedures at paragraph (b) of this regional, State, and Federal emergency (4) Include a unified and integrated section, and the communication plan at preparedness officials’ efforts to emergency plan that meets the paragraph (c) of this section. The maintain an integrated response during requirements of paragraphs (a)(2), (3), training and testing program must be a disaster or emergency situation, and (4) of this section. The unified and reviewed and updated at least annually. integrated emergency plan must also be including documentation of the OPO’s (1) Training. The OPO must do all of based on and include all of the efforts to contact such officials and, the following: following: when applicable, of its participation in (i) Initial training in emergency (i) A documented community-based collaborative and cooperative planning preparedness policies and procedures to risk assessment, utilizing an all-hazards efforts. all new and existing staff, individuals approach. (b) Policies and procedures. The OPO providing services under arrangement, (ii) A documented individual facility- must develop and implement and volunteers, consistent with their based risk assessment for each emergency preparedness policies and expected roles. separately certified facility within the procedures, based on the emergency (ii) Provide emergency preparedness health system, utilizing an all-hazards plan set forth in paragraph (a) of this training at least annually. approach. section, risk assessment at paragraph (iii) Maintain documentation of the (5) Include integrated policies and (a)(1) of this section, and, the training. procedures that meet the requirements communication plan at paragraph (c) of (iv) Demonstrate staff knowledge of set forth in paragraph (b) of this section, this section. The policies and emergency procedures. a coordinated communication plan and procedures must be reviewed and (2) Testing. The OPO must conduct training and testing programs that meet updated at least annually. At a exercises to test the emergency plan. the requirements of paragraphs (c) and minimum, the policies and procedures The OPO must do the following: (d) of this section, respectively. must address the following: (i) Conduct a paper-based, tabletop (1) A system to track the location of exercise at least annually. A tabletop PART 486—CONDITIONS FOR on-duty staff during and after an exercise is a group discussion led by a COVERAGE OF SPECIALIZED emergency. If on-duty staff is relocated facilitator, using a narrated, clinically- SERVICES FURNISHED BY during the emergency, the OPO must relevant emergency scenario, and a set SUPPLIERS document the specific name and of problem statements, directed location of the receiving facility or other messages, or prepared questions ■ 33. The authority citation for part 486 location. designed to challenge an emergency continues to read as follows: (2) A system of medical plan. Authority: Secs. 1102, 1138, and 1871 of documentation that preserves potential (ii) Analyze the OPO’s response to the Social Security Act (42 U.S.C. 1302, and actual donor information, protects and maintain documentation of all

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tabletop exercises, and emergency (i) A documented community-based FQHC’s efforts to contact such officials events, and revise the OPO’s emergency risk assessment, utilizing an all-hazards and, when applicable, of its plan, as needed. approach. participation in collaborative and (e) Continuity of OPO operations (ii) A documented individual facility- cooperative planning efforts. during an emergency. Each OPO must based risk assessment for each (b) Policies and procedures. The RHC/ have a plan to continue operations separately certified facility within the FQHC must develop and implement during an emergency. health system, utilizing an all-hazards emergency preparedness policies and (1) The OPO must develop and approach. procedures, based on the emergency maintain in the protocols with (5) Include integrated policies and plan set forth in paragraph (a) of this transplant programs required under procedures that meet the requirements section, risk assessment at paragraph § 486.344(d), mutually agreed upon set forth in paragraph (b) of this section, (a)(1) of this section, and the protocols that address the duties and a coordinated communication plan and communication plan at paragraph (c) of responsibilities of the transplant training and testing programs that meet this section. The policies and program, the hospital in which the the requirements of paragraphs (c) and procedures must be reviewed and transplant program is operated, and the (d) of this section, respectively. updated at least annually. At a OPO during an emergency. minimum, the policies and procedures PART 491—CERTIFICATION OF must address the following: (2) The OPO must have the capability CERTAIN HEALTH FACILITIES to continue its operation from an (1) Safe evacuation from the RHC/ FQHC, which includes appropriate alternate location during an emergency. ■ 35. The authority citation for part 491 placement of exit signs; staff The OPO could either have: continues to read as follows: responsibilities and needs of the (i) An agreement with one or more Authority: Sec. 1102 of the Social Security patients. other OPOs to provide essential organ Act (42 U.S.C. 1302); and sec. 353 of the (2) A means to shelter in place for procurement services to all or a portion Public Health Service Act (42 U.S.C. 263a). patients, staff, and volunteers who of its DSA in the event the OPO cannot § 491.6 [Amended] remain in the facility. provide those services during an (3) A system of medical ■ emergency; 36. Amend § 491.6 by removing documentation that preserves patient (ii) If the OPO has more than one paragraph (c). information, protects confidentiality of location, an alternate location from ■ 37. Add § 491.12 to read as follows: patient information, and secures and which the OPO could conduct its § 491.12 Emergency preparedness. maintains the availability of records. operation; or (4) The use of volunteers in an (iii) A plan to relocate to another The Rural Health Clinic/Federally emergency or other emergency staffing location as part of its emergency plan as Qualified Health Center (RHC/FQHC) strategies, including the process and required by paragraph (a) of this section. must comply with all applicable role for integration of State and (f) Integrated healthcare systems. If an Federal, State, and local emergency Federally designated health care OPO is part of a healthcare system preparedness requirements. The RHC/ professionals to address surge needs consisting of multiple separately FQHC must establish and maintain an during an emergency. certified healthcare facilities that elects emergency preparedness program that (c) Communication plan. The RHC/ to have a unified and integrated meets the requirements of this section. FQHC must develop and maintain an emergency preparedness program, the The emergency preparedness program emergency preparedness OPO may choose to participate in the must include, but not be limited to, the communication plan that complies with healthcare system’s coordinated following elements: Federal, State, and local laws and must emergency preparedness program. If (a) Emergency plan. The RHC/FQHC be reviewed and updated at least elected, the unified and integrated must develop and maintain an annually. The communication plan emergency preparedness program must emergency preparedness plan that must must include all of the following: do all of the following: be reviewed and updated at least (1) Names and contact information for annually. The plan must do all of the (1) Demonstrate that each separately the following: following: certified facility within the system (i) Staff. (1) Be based on and include a (ii) Entities providing services under actively participated in the development documented, facility-based and of the unified and integrated emergency arrangement. community-based risk assessment, (iii) Patients’ physicians. preparedness program. utilizing an all-hazards approach. (2) Be developed and maintained in a (iv) Other RHCs/FQHCs. (2) Include strategies for addressing (v) Volunteers. manner that takes into account each emergency events identified by the risk (2) Contact information for the separately certified facility’s unique assessment. following: circumstances, patient populations, and (3) Address patient population, (i) Federal, State, tribal, regional, and services offered. including, but not limited to, the type of local emergency preparedness staff. (3) Demonstrate that each separately services the RHC/FQHC has the ability (ii) Other sources of assistance. certified facility is capable of actively to provide in an emergency; and (3) Primary and alternate means for using the unified and integrated continuity of operations, including communicating with the following: emergency preparedness program and is delegations of authority and succession (i) RHC/FQHC’s staff. in compliance. plans. (ii) Federal, State, tribal, regional, and (4) Include a unified and integrated (4) Include a process for cooperation local emergency management agencies. emergency plan that meets the and collaboration with local, tribal, (4) A means of providing information requirements of paragraphs (a)(2), (3), regional, State, and Federal emergency about the general condition and location and (4) of this section. The unified and preparedness officials’ efforts to of patients under the facility’s care as integrated emergency plan must also be maintain an integrated response during permitted under 45 CFR 164.510(b)(4). based on and include all of the a disaster or emergency situation, (5) A means of providing information following: including documentation of the RHC/ about the RHC/FQHC’s needs, and its

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ability to provide assistance, to the emergency preparedness program, the equipment or power failures, care- authority having jurisdiction or the RHC/FQHC may choose to participate in related emergencies, water supply Incident Command Center, or designee. the healthcare system’s coordinated interruption, and natural disasters likely (d) Training and testing. The RHC/ emergency preparedness program. If to occur in the facility’s geographic area. FQHC must develop and maintain an elected, the unified and integrated The dialysis facility must establish and emergency preparedness training and emergency preparedness program must maintain an emergency preparedness testing program that is based on the do all of the following: program that meets the requirements of emergency plan set forth in paragraph (1) Demonstrate that each separately this section. The emergency (a) of this section, risk assessment at certified facility within the system preparedness program must include, but paragraph (a)(1) of this section, policies actively participated in the development not be limited to, the following and procedures at paragraph (b) of this of the unified and integrated emergency elements: section, and the communication plan at preparedness program. (a) Emergency plan. The dialysis paragraph (c) of this section. The (2) Be developed and maintained in a facility must develop and maintain an training and testing program must be manner that takes into account each emergency preparedness plan that must reviewed and updated at least annually. separately certified facility’s unique be evaluated and updated at least (1) Training program. The RHC/FQHC circumstances, patient populations, and annually. The plan must do all of the must do all of the following: services offered. following: (i) Initial training in emergency (3) Demonstrate that each separately (1) Be based on and include a preparedness policies and procedures to certified facility is capable of actively documented, facility-based and all new and existing staff, individuals using the unified and integrated community-based risk assessment, providing services under arrangement, emergency preparedness program and is utilizing an all-hazards approach. and volunteers, consistent with their in compliance with the program. (2) Include strategies for addressing expected roles, (4) Include a unified and integrated emergency events identified by the risk (ii) Provide emergency preparedness emergency plan that meets the assessment. training at least annually. requirements of paragraphs (a)(2), (3), (3) Address patient population, (iii) Maintain documentation of the and (4) of this section. The unified and including, but not limited to, the type of training. integrated emergency plan must also be services the dialysis facility has the (iv) Demonstrate staff knowledge of based on and include all of the ability to provide in an emergency; and emergency procedures. following: continuity of operations, including (2) Testing. The RHC/FQHC must (i) A documented community–based delegations of authority and succession conduct exercises to test the emergency risk assessment, utilizing an all-hazards plans. plan at least annually. The RHC/FQHC approach. (4) Include a process for cooperation must do the following: (ii) A documented individual facility- and collaboration with local, tribal, (i) Participate in a full-scale exercise based risk assessment for each regional, State, and Federal emergency that is community-based or when a separately certified facility within the preparedness officials’ efforts to community-based exercise is not health system, utilizing an all-hazards maintain an integrated response during accessible, an individual, facility-based. approach. a disaster or emergency situation, If the RHC/FQHC experiences an actual (5) Include integrated policies and including documentation of the dialysis natural or man-made emergency that procedures that meet the requirements facility’s efforts to contact such officials requires activation of the emergency set forth in paragraph (b) of this section, and, when applicable, of its plan, the RHC/FQHC is exempt from a coordinated communication plan, and participation in collaborative and engaging in a community-based or training and testing programs that meet cooperative planning efforts. The individual, facility-based full-scale the requirements of paragraphs (c) and dialysis facility must contact the local exercise for 1 year following the onset (d) of this section, respectively. emergency preparedness agency at least of the actual event. annually to confirm that the agency is (ii) Conduct an additional exercise PART 494—CONDITIONS FOR aware of the dialysis facility’s needs in that may include, but is not limited to COVERAGE FOR END-STAGE RENAL the event of an emergency. following: DISEASE FACILITIES (b) Policies and procedures. The (A) A second full-scale exercise that is dialysis facility must develop and community-based or individual, facility- ■ 38. The authority citation for part 494 implement emergency preparedness based. continues to read as follows: policies and procedures, based on the (B) A tabletop exercise that includes Authority: Secs. 1102 and 1871 of the emergency plan set forth in paragraph a group discussion led by a facilitator, Social Security Act (42 U.S.C. l302 and (a) of this section, risk assessment at using a narrated, clinically-relevant l395hh). paragraph (a)(1) of this section, and the emergency scenario, and a set of communication plan at paragraph (c) of problem statements, directed messages, § 494.60 [Amended] this section. The policies and or prepared questions designed to ■ 39. Amend § 494.60 by removing procedures must be reviewed and challenge an emergency plan. paragraph (d) and redesignating updated at least annually. These (iii) Analyze the RHC/FQHC’s paragraph (e) as paragraph (d). emergencies include, but are not limited response to and maintain ■ 40. Add § 494.62 to subpart B to read to, fire, equipment or power failures, documentation of all drills, tabletop as follows: care-related emergencies, water supply exercises, and emergency events, and interruption, and natural disasters likely revise the RHC/FQHC’s emergency plan, § 494.62 Condition of participation: to occur in the facility’s geographic area. as needed. Emergency preparedness. At a minimum, the policies and (e) Integrated healthcare systems. If a The dialysis facility must comply procedures must address the following: RHC/FQHC is part of a healthcare with all applicable Federal, State, and (1) A system to track the location of system consisting of multiple separately local emergency preparedness on-duty staff and sheltered patients in certified healthcare facilities that elects requirements. These emergencies the dialysis facility’s care during and to have a unified and integrated include, but are not limited to, fire, after an emergency. If on-duty staff and

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sheltered patients are relocated during (3) Primary and alternate means for (D) How to disconnect themselves the emergency, the dialysis facility must communicating with the following: from the dialysis machine if an document the specific name and (i) Dialysis facility’s staff. emergency occurs. location of the receiving facility or other (ii) Federal, State, tribal, regional, or (iv) Demonstrate that, at a minimum, location. local emergency management agencies. its patient care staff maintains current (2) Safe evacuation from the dialysis (4) A method for sharing information CPR certification; and facility, which includes staff and medical documentation for patients (v) Properly train its nursing staff in responsibilities, and needs of the under the dialysis facility’s care, as the use of emergency equipment and patients. necessary, with other health care emergency drugs. (3) A means to shelter in place for providers to maintain the continuity of (vi) Maintain documentation of the patients, staff, and volunteers who care. training. remain in the facility. (5) A means, in the event of an (2) Testing. The dialysis facility must (4) A system of medical evacuation, to release patient conduct exercises to test the emergency documentation that preserves patient information as permitted under 45 CFR plan at least annually. The dialysis information, protects confidentiality of 164.510(b)(1)(ii). facility must do all of the following: (i) Participate in a full-scale exercise patient information, and secures and (6) A means of providing information that is community-based or when a maintains the availability of records. about the general condition and location community-based exercise is not (5) The use of volunteers in an of patients under the facility’s care as accessible, an individual, facility-based. emergency or other emergency staffing permitted under 45 CFR 164.510(b)(4). If the dialysis facility experiences an strategies, including the process and (7) A means of providing information actual natural or man-made emergency role for integration of State or Federally about the dialysis facility’s needs, and that requires activation of the designated health care professionals to its ability to provide assistance, to the emergency plan, the ESRD is exempt address surge needs during an authority having jurisdiction or the from engaging in a community-based or emergency. Incident Command Center, or designee. individual, facility-based full-scale (6) The development of arrangements (d) Training, testing, and orientation. exercise for 1 year following the onset with other dialysis facilities or other The dialysis facility must develop and of the actual event. providers to receive patients in the maintain an emergency preparedness event of limitations or cessation of (ii) Conduct an additional exercise training, testing and patient orientation that may include, but is not limited to operations to maintain the continuity of program that is based on the emergency services to dialysis facility patients. the following: plan set forth in paragraph (a) of this (A) A second full-scale exercise that is (7) The role of the dialysis facility section, risk assessment at paragraph under a waiver declared by the community-based or individual, facility- (a)(1) of this section, policies and based. Secretary, in accordance with section procedures at paragraph (b) of this 1135 of the Act, in the provision of care (B) A tabletop exercise that includes section, and the communication plan at a group discussion led by a facilitator, and treatment at an alternate care site paragraph (c) of this section. The identified by emergency management using a narrated, clinically-relevant training, testing, and patient orientation emergency scenario, and a set of officials. program must be evaluated and updated (8) How emergency medical system problem statements, directed messages, at least annually. assistance can be obtained when or prepared questions designed to (1) Training program. The dialysis needed. challenge an emergency plan. facility must do all of the following: (9) A process by which the staff can (iii) Analyze the dialysis facility’s (i) Provide initial training in confirm that emergency equipment, response to and maintain emergency preparedness policies and including, but not limited to, oxygen, documentation of all drills, tabletop procedures to all new and existing staff, airways, suction, defibrillator or exercises, and emergency events, and individuals providing services under automated external defibrillator, revise the dialysis facility’s emergency arrangement, and volunteers, consistent artificial resuscitator, and emergency plan, as needed. with their expected roles. drugs, are on the premises at all times (3) Patient orientation: Emergency and immediately available. (ii) Provide emergency preparedness preparedness patient training. The (c) Communication plan. The dialysis training at least annually. Staff training facility must provide appropriate facility must develop and maintain an must: orientation and training to patients, emergency preparedness (iii) Demonstrate staff knowledge of including the areas specified in communication plan that complies with emergency procedures, including paragraph (d)(1) of this section. Federal, State, and local laws and must informing patients of— (e) Integrated healthcare systems. If a be reviewed and updated at least (A) What to do; dialysis facility is part of a healthcare annually. The communication plan (B) Where to go, including system consisting of multiple separately must include all of the following: instructions for occasions when the certified healthcare facilities that elects (1) Names and contact information for geographic area of the dialysis facility to have a unified and integrated the following: must be evacuated; emergency preparedness program, the (i) Staff. (C) Whom to contact if an emergency dialysis facility may choose to (ii) Entities providing services under occurs while the patient is not in the participate in the healthcare system’s arrangement. dialysis facility. This contact coordinated emergency preparedness (iii) Patients’ physicians. information must include an alternate program. If elected, the unified and (iv) Other dialysis facilities. emergency phone number for the integrated emergency preparedness (v) Volunteers. facility for instances when the dialysis program must do all of the following: (2) Contact information for the facility is unable to receive phone calls (1) Demonstrate that each separately following: due to an emergency situation (unless certified facility within the system (i) Federal, State, tribal, regional or the facility has the ability to forward actively participated in the development local emergency preparedness staff. calls to a working phone number under of the unified and integrated emergency (ii) Other sources of assistance. such emergency conditions); and preparedness program.

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(2) Be developed and maintained in a based on and include all of the the requirements of paragraphs (c) and manner that takes into account each following: (d) of this section, respectively. separately certified facility’s unique (i) A documented community–based Dated: March 9, 2016. circumstances, patient populations, and risk assessment, utilizing an all-hazards Andrew M. Slavitt, services offered. approach. Acting Administrator, Centers for Medicare (3) Demonstrate that each separately (ii) A documented individual facility- & Medicaid Services. certified facility is capable of actively based risk assessment for each Dated: April 6, 2016. using the unified and integrated separately certified facility within the Sylvia M. Burwell, emergency preparedness program and is health system, utilizing an all-hazards Secretary, Department of Health and Human in compliance with the program. approach. Services. (4) Include a unified and integrated (5) Include integrated policies and Editorial Note: This document was emergency plan that meets the procedures that meet the requirements received by the Office of the Federal Register requirements of paragraphs (a)(2), (3), set forth in paragraph (b) of this section, for publication on September 1, 2016. and (4) of this section. The unified and a coordinated communication plan and [FR Doc. 2016–21404 Filed 9–8–16; 4:15 pm] integrated emergency plan must also be training and testing programs that meet BILLING CODE 4120–01–P

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