# Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2013-30724 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** December 27, 2013 - **Citation:** 78 FR 79082 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 403, 416, 418, 441, 460, 482, 483, 484, 485, 486, 491, and 494 [CMS-3178-P] RIN 0938-AO91 Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would establish national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that they adequately plan for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It would also ensure that these providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. We are proposing emergency preparedness requirements that 17 provider and supplier types must meet to participate in the Medicare and Medicaid programs. Since existing Medicare and Medicaid requirements vary across the types of providers and suppliers, we are also proposing variations in these requirements. These variations are based on existing statutory and regulatory policies and differing needs of each provider or supplier type and the individuals to whom they provide health care services. Despite these variations, our proposed regulations would provide generally consistent emergency preparedness requirements, enhance patient safety during emergencies for persons served by Medicare- and Medicaid-participating facilities, and establish a more coordinated and defined response to natural and man-made disasters. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on February 25, 2014. ADDRESSES: In commenting, please refer to file code CMS-3178-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3178-P, P.O. Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period: a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members. Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Janice Graham, (410) 786-8020. Mary Collins, (410) 786-3189. Diane Corning, (410) 786-8486. Ronisha Davis, (410) 786-6882. Lisa Parker, (410) 786-4665. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. Acronyms AAAHC Accreditation Association for Ambulatory Health Care, Inc. AAAASF American Association for Accreditation for Ambulatory Surgery Facilities, Inc. AAR/IP After Action Report/Improvement Plan ACHC Accreditation Commission for Health Care, Inc. ACHE American College of Healthcare Executives AHA American Hospital Association AO Accrediting Organization AOA American Osteopathic Association ASC Ambulatory Surgical Center ARCAH Accreditation Requirements for Critical Access Hospitals ASPR Assistant Secretary for Preparedness and Response BLS Bureau of Labor Statistics BTCDP Bioterrorism Training and Curriculum Development Program CAH Critical Access Hospital CAMCAH Comprehensive Accreditation Manual for Critical Access Hospitals CAMH Comprehensive Accreditation Manual for Hospitals CASPER Certification and the Survey Provider Enhanced Reporting CDC Centers for Disease Control and Prevention CFC Conditions for Coverage CHAP Community Health Accreditation Program CMHC Community Mental Health Center COI Collection of Information COP Conditions of Participation CORF Comprehensive Outpatient Rehabilitation Facilities CPHP Centers for Public Health Preparedness CRI Cities Readiness Initiative DHS Department of Homeland Security DHHS Department of Health and Human Services DOL Department of Labor DPU Distinct Part Units DSA Donation Service Area EOP Emergency Operations Plans EC Environment of Care EMP Emergency Management Plan EP Emergency Preparedness ESF Emergency Support Function ESRD End-Stage Renal Disease FEMA Federal Emergency Management Agency FDA Food and Drug Administration FQHC Federally Qualified Health Clinic GAO Government Accountability Office HFAP Healthcare Facilities Accreditation Program HHA Home Health Agencies HPP Hospital Preparedness Program HRSA Health Resources and Services Administration HSC Homeland Security Council HSEEP Homeland Security Exercise and Evaluation Program HSPD Homeland Security Presidential Directive HVA Hazard Vulnerability Analysis ICFs/IID Intermediate Care Facilities for Individuals with Intellectual Disabilities ICR Information Collection Requirements IDG Interdisciplinary Group IOM Institute of Medicine JCAHO Joint Commission on the Accreditation of Healthcare Organizations JPATS Joint Patient Assessment and Tracking System LD Leadership LPHA Local Public Health Agencies LSC Life Safety Code LTC Long Term Care MMRS Metropolitan Medical Response System MS Medical Staff NDMS National Disaster Medical System NF Nursing Facilities NFPA National Fire Protection Association NIMS National Incident Management System NIOSH National Institute for Occupational Safety and Health NLTN National Laboratory Training Network NRP National Response Plan NRF National Response Framework NSS National Security Staff OBRA Omnibus Budget Reconciliation Act OIG Office of the Inspector General OPHPR Office of Public Health Preparedness and Response OPO Organ Procurement Organization OPT Outpatient Physical Therapy OPTN Organ Procurement and Transplantation Network OSHA Occupational Safety and Health Administration ORHP Office of Rural Health Policy PACE Program for the All-Inclusive Care for the Elderly PAHPA Pandemic and All-Hazards Preparedness Act PHEP Public Health Emergency Preparedness PIN Policy Information Notice PPD Presidential Policy Directive PRTF Psychiatric Residential Treatment Facilities QAPI Quality Assessment and Performance Improvement QIES Quality Improvement and Evaluation System RFA Regulatory Flexibility Act RNHCI Religious Nonmedical Health Care Institutions RHC Rural Health Clinic SAMHSA Substance Abuse and Mental Health Services Administration SLP Speech Language Pathology SNF Skilled Nursing Facility SNS Strategic National Stockpile TEFRA Tax Equity and Fiscal Responsibility Act TFAH Trust for America's Health TJC The Joint Commission TTX Tabletop Exercise UMRA Unfunded Mandates Reform Act UPMC University of Pittsburgh Medical Center WHO World Health Organization Table of Contents I. Overview A. Executive Summary 1. Purpose 2. Summary of the Major Provisions B. Current State of Emergency Preparedness 1. Federal Emergency Preparedness 2. State and Local Emergency Preparedness 3. Hospital Preparedness 4. GAO and OIG Reports C. Statutory and Regulatory Background II. Provisions of the Proposed Regulation A. Emergency Preparedness Regulations for Hospitals (§ 482.15) 1. Emergency Plan a. Emergency Planning Resources b. Risk Assessment c. Patient Population and Available Services d. Succession Planning and Cooperative Efforts 2. Policies and Procedures 3. Communication Plan 4. Training and Testing B. Emergency Preparedness Regulations for Religious Nonmedical Health Care Institutions (RNHCIs) (§ 403.748) C. Emergency Preparedness Regulations for Ambulatory Surgical Centers (ASCs) (§ 416.54) D. Emergency Preparedness Regulations for Hospice (§ 418.113) E. Emergency Preparedness Regulations for Inpatient Psychiatric Residential Treatment Facilities (PRTFs) (§ 441.184) F. Emergency Preparedness Regulations for Programs of All-Inclusive Care for the Elderly (PACE) (§ 460.84) G. Emergency Preparedness Regulations for Transplant Centers (§ 482.78) H. Emergency Preparedness Regulations for Long-Term Care (LTC) Facilities (§ 483.73) I. Emergency Preparedness Regulations for Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) (§ 483.475) J. Emergency Preparedness Regulations for Home Health Agencies (HHAs) (§ 484.22) K. Emergency Preparedness Regulations for Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§ 485.68) L. Emergency Preparedness Regulations for Critical Access Hospitals (CAHs) (§ 485.625) M. Emergency Preparedness Regulations for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (§ 485.727) N. Emergency Preparedness Regulations for Community Mental Health Centers (CMHCs) (§ 485.920) O. Emergency Preparedness Regulations for Organ Procurement Organizations (OPOs) (§ 486.360) P. Emergency Preparedness Regulations for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (§ 491.12) Q. Emergency Preparedness Regulations for End-Stage Renal Disease (ESRD) Facilities (§ 494.62) III. Collection of Information A. Factors Influencing ICR Burden Estimates B. Sources of Data Used in Estimates of Burden Hours and Cost Estimates C. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 403.748) D. ICRs Regarding Condition for Coverage: Emergency Preparedness (§ 416.54) E. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 418.113) F. ICRs Regarding Emergency Preparedness (§ 441.184) G. ICRs Regarding Emergency Preparedness (§ 460.84) H. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 482.15) I. ICRs Regarding Condition of Participation: Emergency Preparedness for Transplant Centers (§ 482.78) J. ICRs Regarding Emergency Preparedness (§ 483.73) K. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 483.475) L. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 484.22) M. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 485.68) N. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 485.625) O. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 485.727) P. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 485.920) Q. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 486.360) R. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 491.12) S. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 494.62) T. Summary of Information Collection Burden IV. Regulatory Impact Analysis (RIA) A. Statement of Need B. Overall Impact C. Anticipated Effects on Providers and Suppliers: General Provisions D. Condition of Participation: Emergency Preparedness for Religious Nonmedical Health Care Institutions (RNHCIs) E. Condition for Coverage: Emergency Preparedness for Ambulatory Surgical Centers (ASCs)—Testing (§ 416.54(d)(2)) F. Condition of Participation: Emergency Preparedness for Hospices—Testing (§ 418.113(d)(2)) G. Emergency Preparedness for Psychiatric Residential Treatment Facilities (PRTFs) Training and Testing (§ 441.184(d)) H. Emergency Preparedness for Program for the All-Inclusive Care for the Elderly (PACE) Organizations—Training and Testing (§ 460.84(d)) I. Condition of Participation: Emergency Preparedness for Hospitals J. Condition of Participation: Emergency Preparedness for Transplant Centers K. Emergency Preparedness for Long Term Care (LTC) Facilities L. Condition of Participation: Emergency Preparedness for Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs/IID) M. Condition of Participation: Emergency Preparedness for Home Health Agencies (HHAs) N. Conditions of Participation: Comprehensive Outpatient Rehabilitation Facilities (CORFs)— (§ 485.68(d)(2)(i) through (iii)) O. Condition of Participation: Emergency Preparedness for Critical Access Hospitals (CAHs)—Testing (§ 485.625(d)(2)) P. Condition of Participation: Emergency Preparedness for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology (“Organizations”)—Testing (§ 485.727(d)(2)(i) Through (iii)) Q. Condition of Participation: Emergency Preparedness for Community Mental Health Centers (CMHCs)—Training and Testing (§ 485.920(d)) R. Conditions of Participation: Emergency Preparedness for Organ Procurement Organizations (OPOs)—Training and Testing (§ 486.360(d)(2)(i) Through (iii)) S. Emergency Preparedness: Conditions for Certification for Rural Health Clinics (RHCs) and Conditions for Coverage for Federally Qualified Health Clinics (FQHCs) T. Condition of Participation: Emergency Preparedness for End-Stage Renal Disease Facilities (Dialysis Facilities)—Testing (§ 494.62(d)(2)(i) through (iv)) U. Summary of the Total Costs V. Benefits of the Proposed Rule W. Alternatives Considered X. Accounting Statement Appendix—Emergency Preparedness Resource Documents and Sites I. Overview A. Executive Summary 1. Purpose Over the past several years, the United States has been challenged by several natural and man-made disasters. As a result of the September 11, 2001 terrorist attacks, the subsequent anthrax attacks, the catastrophic hurricanes in the Gulf Coast states in 2005, flooding in the Midwestern states in 2008, tornadoes and floods in the spring of 2011, the 2009 H1N1 influenza pandemic, and Hurricane Sandy in 2012, readiness for public health emergencies has been put on the national agenda. For the purpose of this proposed regulation, “emergency” or “disaster” can be defined as an event affecting the overall target population or the community at large that precipitates the declaration of a state of emergency at a local, state, regional, or national level by an authorized public official such as a governor, the Secretary of the Department of Health and Human Services (HHS), or the President of the United States. (See Health Resources and Services Administration (HRSA) Policy Information notice entitled, “Health Center Emergency Management Program Expectations,” (Document No. 2007-15, dated August 22, 2007, found at http://www.hsdl.org/?view&did=478559 ). Disasters can disrupt the environment of health care and change the demand for health care services. This makes it essential that health care providers and suppliers ensure that emergency management is integrated into their daily functions and values. In preparing this proposed rule, we reviewed the guidance, developed by the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), and the Office of the Assistant Secretary for Preparedness and Response (ASPR). Additionally, we held regular meetings with these agencies and ASPR to collaborate on federal emergency preparedness requirements. To guide us in the development of this rule, we also reviewed several other sources to find the most current best practices in the health care industry. These sources included other federal agencies; The Joint Commission (TJC) standards for emergency preparedness; the American Osteopathic Association (AOA) standards for disaster preparedness (currently written for Critical Access Hospitals (CAHs) only); the National Fire Protection Association (NFPA) standards in NFPA 101 Life Safety Code and NFPA 1600: “Standard on Disaster/Emergency Management and Business Continuity Programs,” 2007 Edition; state-level requirements for some states, including those for California and Maryland; and policy guidance from the American College of Healthcare Executives (ACHE), entitled the “Healthcare Executives' Role in Emergency Preparedness,” which reinforces our position regarding the necessity of this proposed rule. Many of the resources we reviewed in the development of this proposed rule are listed in the APPENDIX—“Emergency Preparedness Resource Documents and Sites.” We encourage providers and suppliers to use these resources to develop and maintain their emergency preparedness plans. We also reviewed existing Medicare emergency preparedness requirements for both providers and suppliers. We concluded that current emergency preparedness regulatory requirements are not comprehensive enough to address the complexities of actual emergencies. Specifically, the requirements do not address the need for: (1) Communication to coordinate with other systems of care within local jurisdictions (for example. cities, counties) or states; (2) contingency planning; and (3) training of personnel. Based on our analysis of the written reports, articles, and studies, as well as on our ongoing dialogue with representatives from the federal, state, and local levels and with various stakeholders, we believe that, currently, in the event of a disaster, health care providers and suppliers across the nation would not have the necessary emergency planning and preparation in place to adequately protect the health and safety of their patients. Underlying this problem is the pressing need for a more consistent regulatory approach that would ensure that providers and suppliers nationwide are required to plan for and respond to emergencies and disasters that directly impact patients, residents, clients, participants, and their communities. As we have learned from past events and disasters, the current regulatory patchwork of federal, state, and local laws and guidelines, combined with the various accrediting organization emergency preparedness standards, falls far short of what is needed to require that health care providers and suppliers be adequately prepared for a disaster. Thus, we are proposing these emergency preparedness requirements to establish a comprehensive, consistent, flexible, and dynamic regulatory approach to emergency preparedness and response that incorporates the lessons learned from the past, combined with the proven best practices of the present. We recognize that central to this approach is to develop and guide emergency preparedness and response within the framework of our national health care system. To this end, these proposed regulations would also encourage providers and suppliers to coordinate their preparedness efforts within their own communities and states as well as across state lines, as necessary to achieve their goals. We are soliciting comments on whether certain requirements should be implemented on a staggered basis. 2. Summary of the Major Provisions We are proposing emergency preparedness requirements that will be consistent and enforceable for all affected Medicare and Medicaid providers and suppliers. This proposed rule addresses the three key essentials needed to ensure that health care is available during emergencies: safeguarding human resources, ensuring business continuity, and protecting physical resources. Current regulations for Medicare and Medicaid providers and suppliers do not adequately address these key elements. Based on our research and consultation with stakeholders, we have identified four core elements that are central to an effective and comprehensive framework of emergency preparedness requirements for the various Medicare and Medicaid participating providers and suppliers. The four elements of the emergency preparedness program are as follows: • Risk assessment and planning: This proposed rule would propose that prior to establishing an emergency plan, a risk assessment would be performed based on utilizing an “all-hazards” approach. An all-hazards approach is an integrated approach to emergency preparedness planning that focuses on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters. This approach is specific to the location of the provider and supplier considering the particular types of hazards which may most likely occur in their area. • Policies and procedures: We are proposing that facilities be required to develop and implement policies and procedures based on the emergency plan and risk assessment. • Communication plan: This proposed rule would require a facility to develop and maintain an emergency preparedness communication plan that complies with both federal and state law. Patient care must be well-coordinated within the facility, across health care providers, and with state and local public health departments and emergency systems to protect patient health and safety in the event of a disaster. • Training and testing: We are proposing that a facility develop and maintain an emergency preparedness training and testing program. A well-organized, effective training program must include providing initial training in emergency preparedness policies and procedures. We propose that the facility ensure that staff can demonstrate knowledge of emergency procedures and provide this training at least annually. We would require that facilities conduct drills and exercises to test the emergency plan. We are seeking public comments on when these CoPs should be implemented. B. Current State of Emergency Preparedness 1. Federal Emergency Preparedness In response to the September 11, 2001 terrorist attacks and the subsequent national need to refine the nation's strategy to handle emergency situations, there have been numerous efforts across federal agencies to establish a foundation for development and expansion of emergency preparedness systems. The following is a brief overview of some emergency preparedness activities at the federal level. Additional information is included in the appendix to this proposed rule. a. Presidential Directives Three Presidential Directives HSPD-5, HSPD-21 and PPD-8, require agencies to coordinate their emergency preparedness activities with each other and across federal, state, local, tribal, and territorial governments. Although these directives do not specifically require Medicare providers and suppliers to adopt such measures, they have set the stage for what we expect from our providers and suppliers in regard to their roles in a more unified emergency preparedness system. The Homeland Security Presidential Directive (HSPD-5), “Management of Domestic Incidents,” was issued on February 28, 2003. This directive authorizes the Department of Homeland Security to develop and administer the National Incident Management System (NIMS). The NIMS provides a consistent national template that enables federal, state, local, and tribal governments, as well as private-sector and nongovernmental organizations, to work together effectively and efficiently to prepare for, prevent, respond to, and recover from domestic incidents, regardless of cause, size, or complexity, including acts of catastrophic terrorism. The Presidential Policy Directive (PPD-8 focuses on strengthening the security and resilience of the nation through systematic preparation for the full range of 21st century hazards that threaten the security of the nation, including acts of terrorism, cyber attacks, pandemics, and catastrophic natural disasters. The directive is founded by 3 key principles which include: (1) employ an all-of-nation/whole community approach, integrate efforts across federal, state, local, tribal and territorial governments; (2) build key capabilities to confront any challenge; and (3) utilize an assessment system focused on outcomes to measure and track progress. Finally, the Presidential directive published on October 18, 2007, entitled, “Homeland Security Presidential Directive/HSPD-21,” addresses public health and medical preparedness. The directive, found at http://www.dhs.gov/xabout/laws/gc_1219263961449.shtm, establishes a National Strategy for Public Health and Medical Preparedness (Strategy), which aims to transform our national approach to protecting the health of the American people against all disasters. HSPD-21 summarizes implementation actions that are the four most critical components of public health and medical preparedness: biosurveillance, countermeasure stockpiling and distribution, mass casualty care, and community resilience. The directive states that these components will receive the highest priority in public health and medical preparedness efforts. b. Assistant Secretary for Preparedness and Response In December 2006, the President signed the Pandemic and All-Hazards Preparedness Act (PAHPA) (Pub. L. 109-417). The purpose of the Pandemic and All-Hazards Preparedness Act is “to improve the Nation's public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental, or natural.” The Office of the Assistant Secretary for Preparedness and Response (ASPR) was created under the PAHPA Act in the wake of Katrina to lead the nation in preventing, preparing for, and responding to the adverse health effects of public health emergencies and disasters. The Secretary of HHS delegates to ASPR the leadership role for all health and medical services support functions in a health emergency or public health event. ASPR also serves as the senior advisor to the HHS Secretary on public health and medical preparedness and provides, at a minimum, support for; building federal emergency medical operational response and recovery capabilities; countermeasures research, advance development, and procurement; and grants to strengthen the capabilities of healthcare preparedness at the state, regional, local and healthcare coalition levels for public health emergencies and medical disasters. The office provides federal support, including medical professionals through ASPR's National Disaster Medical System (NDMS), to augment state and local capabilities during an emergency or disaster. The purpose of the NDMS is to establish a single, integrated, and national medical response capability to assist state and local authorities in dealing with the medical impacts of major peacetime disasters and to provide support to the military and the Department of Veterans Affairs medical systems in caring for casualties evacuated back to the U.S. from overseas conflicts. The NDMS, as part of the HHS, led by ASPR, supports federal agencies in the management and coordination of the federal medical response to major emergencies and federally declared disasters including natural disasters, technological disasters, major transportation accidents, and acts of terrorism, including weapons of mass destruction events. Additional information can be found at: http://www.phe.gov/preparedness/responders/ndms/Pages/default.aspx. ASPR also administers the Hospital Preparedness Program (HPP), which provides leadership and funding through grants and cooperative agreements to states, territories, and eligible municipalities to improve surge capacity and enhance community and hospital preparedness for public health emergencies. Through the work of its state partners, HPP has advanced the preparedness of hospitals and communities in numerous ways, including building healthcare coalitions, planning for all hazards, increasing surge capacity, tracking the availability of beds and other resources using electronic systems, and developing communication systems that are interoperable with other response partners. The first response in a disaster is always local, and comprised of local government emergency services supplemented by state and volunteer organizations. This aspect of the “disaster response” is specifically coordinated by state and local authorities. When an incident overwhelms or is anticipated to overwhelm state resources, the Governor of a state or chief executive of a tribe may request federal assistance. In such cases, the affected local jurisdiction, tribe, state, and the federal government will collaborate to provide that necessary assistance. When it is clear that state capabilities will be exceeded, the Governor or the tribal executive can request federal assistance, including assistance under the Robert Stafford Disaster Relief and Emergency Assistance Act (Stafford Act). The Stafford Act authorizes the President to provide financial and other assistance to state and local governments, certain private nonprofit organizations, and individuals to support response, recovery, and mitigation efforts following Presidential emergency or major disaster declarations. The National Response Framework (NRF), a guide to how the nation should conduct all hazards responses, includes 15 Emergency Support Functions (ESFs), which are groupings of governmental and certain private sector capabilities into an organizational structure. The purpose of the ESFs is to provide support, resources, program implementation, and services that are most likely needed to save lives, protect property and the environment, restore essential services and critical infrastructure, and help victims and communities return to normal following domestic incidents. HHS is the primary agency responsible for ESF 8—Public Health and Medical Services. The Secretary of HHS leads all federal public health and medical response to public health and medical emergencies and incidents that are covered by the Stafford Act, via NRF, or the Public Health Service Act. Under the NRF, ESF 8 is coordinated by the Secretary of HHS principally through the Assistant Secretary for Preparedness and Response (ASPR). ESF 8—Public Health and Medical Services provides the mechanism for coordinated federal assistance to supplement state, tribal, and local jurisdictional resources in response to a public health and medical disaster, potential or actual incidents requiring a coordinated federal response, or during a developing potential health and medical emergency. c. Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) Office of Public Health Preparedness and Response (OPHPR) leads the agency's preparedness and response activities by providing strategic direction, support, and coordination for activities across CDC as well as with local, state, tribal, national, territorial, and international public health partners. CDC provides funding and technical assistance to states to build and strengthen public health capabilities. Ensuring that states can adequately respond to threats will result in greater health security; a critical component of overall U.S. national security. Additional information can be found at: http://www.cdc.gov/phpr/. The CDC Public Health Emergency Preparedness (PHEP) cooperative agreement, led by OPHPR, is a critical source of funding for state, local, tribal, and territorial public health departments. Since 2002, the PHEP cooperative agreement has provided nearly $9 billion to public health departments across the nation to upgrade their ability to effectively respond to a range of public health threats, including infectious diseases, natural disasters, and biological, chemical, nuclear, and radiological events. Preparedness activities funded by the PHEP cooperative agreement are targeted specifically for the development of emergency-ready public health departments that are flexible and adaptable. The Strategic National Stockpile (SNS), administered by the CDC, is a stockpile of pharmaceuticals and medical supplies. The SNS program was created to assist states and local communities in responding to public health emergencies, including those resulting from terrorist attacks and natural disasters. The SNS program ensures the availability of necessary medicines, antidotes, medical supplies, and medical equipment for states and local communities, to counter the effects of biological pathogens and chemical and nerve agents. ( http://www.cdc.gov/phpr/stockpile/stockpile.htm ). The Cities Readiness Initiative (CRI), led by CDC, is a federally funded pilot program to help cities increase their capacity to deliver medicines and medical supplies within 48 hours after recognition of a large-scale public health emergency such as a bioterrorism attack or a nuclear accident. More information on this effort can be found at: http://www.bt.cdc.gov/cri/. An evaluative report of this program since its inception, requested by the CDC, performed by the RAND Corporation, and published in 2009, entitled, “Initial Evaluation of the Cities Readiness Initiative” can be found at http://www.rand.org/pubs/technical_reports/2009/RAND_TR640.pdf. Given the heightened concern regarding the impact of various influenza outbreaks in recent years, the federal government has created a Web site with “one-step access to U.S. Government H1N1, Avian, and Pandemic Flu Information” at www.flu.gov. The Web site provides links to influenza guidance and information from federal agencies, such as the CDC, as well as checklists for pandemic preparedness. The information and links are found at http://www.flu.gov/professional/index.html. This Web site includes information for hospitals, long term care facilities, outpatient facilities, home health agencies, other health care providers, and clinicians. For example, the “Hospital Pandemic Influenza Planning Checklist” provides guidance on structure for planning and decision making; development of a written pandemic influenza plan; and elements of an influenza pandemic plan. The checklist is comprehensive and lists everything a hospital should do to prepare for a pandemic, from planning for coordination with local and regional planning and response groups to infection control. 2. State and Local Preparedness A review of studies and articles regarding readiness of state and local jurisdictions reveals that there is inconsistency in the level of emergency preparedness amongst states and need for improvement in certain areas. In a report by the Trust for America's Health (TFAH) (December 2012, http://www.healthyamericans.org/report/101/ ) entitled, “Ready or Not? Protecting the Public's Health from Diseases, Disasters, and Bioterrorism” the authors assessed state-by-state public health preparedness nearly 10 years after the September 11th and anthrax tragedies. Using 10 key indicators to rate levels of public health preparedness, some key findings included: (1) 29 states cut public health funding from fiscal years (FY) 2010 through 2012, with 2 of these states cutting funds for a second year in a row and 14 for 3 consecutive years, and that federal funds for state and local preparedness have decreased by 38 percent from FY 2005 through 2012 and (2) 35 states and Washington DC do not currently have complete climate change adaption plans, which include planning for health threats posed by extreme weather events. An article entitled, “Public Health Response to Urgent Case Reports,” published in Health Affairs (August 30, 2005), Dausey, D., Lurie, N., and Diamond, A.) evaluated the ability of local public health agencies (LPHAs) to adequately meet “a preparedness standard” set by the CDC. The standard was for the LPHAs “to receive and respond to urgent case reports of communicable diseases 24 hours a day, 7 days a week.” Using 18 metropolitan area LPHAs that were roughly evenly distributed by agency size, structure, and region of the country, the goal of the test was to contact an “action officer” (that is, physician, nurse, epidemiologist, bioterrorism coordinator, or infection control practitioner) responsible for responding to urgent case reports. During a 4-month period of time, each LPHA was contacted several times and asked questions regarding triage procedures, what questions would be asked in the event of an urgent case being filed, next steps taken after receiving such a report, and who would be contacted. Although the LPHAs had a substantial role in community public health through prevention and treatment efforts, the authors found significant variation in performance and the systems in place to respond to such reports. We also reviewed an article published in June 2004 by Lurie, N., Wasserman, J., Stoto, M., Myers, S., Namkung, P., Fielding, J., and Valdez, R. B., entitled, “Local Variations in Public Health Preparedness: Lessons from California” found at http://content.healthaffairs.org/cgi/content/full/hlthaff.w4.341/DC1. The authors stated that “evidence-based measures to assess public health preparedness are lacking in California.” Using an “expert-panel process,” the researchers developed performance measures based on ten identified essential public health services. They performed site visits and tabletop exercises to evaluate preparedness across the state in geographic locations identified as urban, rural, and border status to detect and respond to a hypothetical smallpox outbreak based on the different measures of preparedness. Overall, the researchers found that there was a lack of consensus regarding what “emergency preparedness” encompassed and a wide variation in what various governmental agencies deemed to be adequate emergency preparedness “readiness” in California. They noted that gaps in the infrastructure were common. Throughout the jurisdictions investigated, there were similarities noted in the shortage of nurses, the number of essential workers nearing retirement age, and the lack of epidemiologists, lab personnel, and public health nurses to meet potential needs. Such gaps in personnel infrastructure were found in many jurisdictions. In some jurisdictions, there was incomplete information regarding the demographics of persons who could be considered potentially vulnerable or part of an underserved population. In one situation, there was also great variability in the length of time it took to bring three suspicious cases to public health officers' attention and for these officers to realize that these cases were related. There was great variation in the public health officers' ability to rapidly alert the physician and hospital community of an outbreak. There was a lack of consensus regarding when to report a potential outbreak to the public. There also was wide variation in knowledge of public health legal authority, specifically, in regard to quarantine and its enforcement. We believe these findings to be typical of most states. 3. Hospital Preparedness Hospitals are the focal points for health care in their respective communities; thus, it is essential that hospitals have the capacity to respond in a timely and appropriate manner in the event of a natural or man-made disaster. Additionally, since Medicare-participating hospitals are required to evaluate and stabilize every patient seen in the emergency department and to evaluate every inpatient at discharge to determine his or her needs and to arrange for post-discharge care as needed, hospitals are in the best position to coordinate emergency preparedness planning with other providers and suppliers in their communities. We would expect hospitals to be prepared to provide care to the greatest number of disaster victims for which they have the capacity, while meeting at least minimal obligations for care to all who are in need. In 2007, ASPR contracted with the Center for Biosecurity of the University of Pittsburgh Medical Center (UPMC) (the Center) to conduct an assessment of U.S. hospital preparedness and to develop recommendations for evaluating and improving future hospital preparedness efforts. The Center's assessment, entitled “Hospitals Rising to the Challenge: The First Five Years of the U.S. Hospital Preparedness Program and Priorities Going Forward” describes the most important components of preparedness for mass casualty response at the local and regional hospital and healthcare system levels. This evaluation report was based on extensive analyses of the published literature, government reports, and HPP program assessments, as well as on detailed conversations with 133 health officials and hospital professionals representing every state, the largest cities, and major territories of the U.S. The authors stated that major disasters can severely challenge the ability of healthcare systems to adequately care for large numbers of patients (surge capacity) or victims with unusual or highly specialized medical needs (surge capability) such as occurred with Hurricane Katrina. The authors further stated that addressing medical surge and medical system resilience requires implementing systems that can effectively manage medical and health responses, as well as developing and maintaining preparedness programs. There were numerous findings and conclusions in the 2007 report. The researchers found that since the start of the HPP in 2002, individual hospitals' disaster preparedness has improved significantly. The report found that hospital senior leadership is actively supporting and participating in preparedness activities, and disaster coordinators within hospitals have given sustained attention to preparedness and response planning efforts. Hospital emergency operations plans (EOPs) have become more comprehensive and, in many locations, are coordinated with community emergency plans and local hazards. Disaster training has become more rigorous and standardized; hospitals have stockpiled emergency supplies and medicines; situational awareness and communications are improving; and exercises are more frequent and of higher quality. The researchers also found improved collaboration and networking among and between hospitals, public health departments, and emergency management and response agencies. These coalitions are believed to represent the beginning of a coordinated community-wide approach to medical disaster response. However, ASPR Healthcare Preparedness Capabilities: National Guidance for Healthcare System Preparedness (2012) and CDC Public Health Preparedness Capabilities: National Standards for State and Local Planning (March 2011) notes numerous federal directives that recognize the need for a consistent approach to preparedness planning across the nation so as to ensure an effective response. The 2010 IOM report also notes that direction at the federal level is essential in order to ensure a coordinated, interoperable disaster response. (IOM Medical Surge Capacity. 2009 Forum on Medical and Public Health Preparedness for Catastrophic Events, 2010)” 4. OIG and GAO Reports Since Katrina, several studies regarding the preparedness of health care providers have been published. In general, these reports and studies point to a need for improved requirements to ensure that providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. In response to a request from the U.S. Senate Special Committee on Aging calling for an examination of nursing home emergency preparedness, the Office of the Inspector General (OIG) conducted a study during 2004 through 2005 entitled, “Nursing Home Emergency Preparedness and Responses During Recent Hurricanes,” (OEI-06-06-00020) http://oig.hhs.gov/oei/reports/oei-06-06-00020.pdf ). The OIG reviewed state survey data for emergency preparedness measures both for the nation in general and for the Gulf States (Alabama, Florida, Louisiana, Mississippi, and Texas). The study indicated that in 2004 through 2005, 94 percent of nursing homes nationwide met the limited federal regulations for emergency plans then in existence, while only 80 percent met the federal standards for emergency training. Similar compliance rates were noted in the Gulf states. However, the OIG found that nursing homes in the Gulf states experienced problems even though they were in compliance with federal interpretive guidelines. Further, they experienced problems whether they evacuated residents or sheltered them in place. The OIG listed the problems encountered by Gulf state nursing homes including, transportation contracts that were not honored; lengthy travel times for residents; insufficient food and water for residents and staff; complicated resident medication needs; host facilities that were unavailable or that were inadequately prepared, provisioned, or staffed for the transfer of residents; and difficulty re-entering their own facilities. As further detailed in the OIG report, the main reasons for these problems were lack of effective planning; failure to properly execute emergency plans; failure to anticipate the specific problems encountered; and failure to adjust decisions and actions to specific situations. The OIG also found that some facility administrators deviated, many significantly, from their emergency plans or worked beyond the plans, either because the plans were not updated or plans did not include instructions for certain circumstances. The report goes on to note that many of the nursing home emergency preparedness plans did not consider the following factors: the need to evacuate residents to alternate sites as evidenced by a formal agreement with a host facility; criteria to determine whether to evacuate residents or shelter them in place; a means by which an individual resident's care needs would be identified and met; and re-entry into the facility following an evacuation. Although some local communities were directly involved in the evacuation of their nursing home residents, other nursing homes received assistance with evacuation from resident and staff family members, parent corporations, and “sister facilities,” according to the OIG report. A few nursing homes reported that problems with state and local government coordination during the hurricanes contributed to the problems they encountered. Based on this study, the OIG had two recommendations for CMS: (1) Strengthen federal certification standards for nursing home emergency plans by including requirements for specific elements of emergency planning; and (2) encourage communication and collaboration between state and local emergency entities and nursing homes. As a result of the OIG's recommendations, the Secretary initiated an emergency preparedness improvement effort to be coordinated across all HHS agencies. Our development of this proposed rule is an important part of HHS-wide efforts to meet the Department's overall emergency preparedness goals and objectives by directly addressing the OIG recommendations. In April 2012, the OIG issued a subsequent report entitled, “Gaps Continue to Exist in Nursing Home Emergency Preparedness and response During Disasters: 2007-2010,” (OEI-06-09-00270 http://oig.hhs.gov/oei/reports/oei-06-09-00270.pdf ). This report notes that many of the gaps in nursing home preparedness and response identified in the 2006 report still exist. We also reviewed several Government Accountability Office (GAO) reports on emergency preparedness. One such report is entitled, “Disaster Preparedness: Preliminary Observations on the Evacuation of Hospitals and Nursing Homes Due to Hurricanes” (GAO-06-443R), was published on February 16, 2006, and can be found at http://www.gao.gov/new.items/d06443r.pdf ). This report discusses the GAO's findings regarding—(1) Responsibility for the decision to evacuate hospitals and nursing homes; (2) the issues administrators consider when deciding to evacuate hospitals and nursing homes; and (3) the federal response capabilities that support evacuation of hospitals and nursing homes. The GAO found that “hospital and nursing home administrators are often responsible for deciding whether to evacuate patients from their facilities due to disasters, including hurricanes or other natural disasters. State and local governments can order evacuations of the population or segments of the population during emergencies, but health care facilities may be exempt from these orders.” The GAO found that hospitals and nursing home administrators evacuate only as a last resort and that these facilities' emergency plans are designed primarily to shelter in place. The GAO also found that administrators considered the availability of adequate resources to shelter in place, the risks to patients in deciding when to evacuate, the availability of transportation to move patients, the availability of receiving facilities to accept patients, and the destruction of the facility's or community's infrastructure. The GAO noted that nursing home administrators also must consider the fact that nursing home residents cannot care for themselves and generally have no home and no place to live other than the nursing home. Therefore, in the event of an evacuation, nursing homes also need to consider the necessity of locating facilities that can accommodate their residents for a long period of time. A second report from the GAO about the hurricanes' impact entitled, “Disaster Preparedness: Limitations in Federal Evacuation Assistance for Health Facilities Should be Addressed,” (GAO-06-826) July, 2006, www.gao.gov/cgi-bin/getrpt?GAO-06-826 ), supports the findings noted in the first GAO report on the disasters. In addition, the GAO noted that the evacuation issues that facilities faced during and after the hurricanes occurred due to their inability to secure transportation when needed. Despite previously established contracts with transportation companies, demand for this assistance overwhelmed the supply of vehicles in the community. A third report, an after-event analysis entitled, “Hurricane Katrina: Status of Hospital Inpatient and Emergency Departments in the Greater New Orleans Area,” (GAO-06-1003) September 29, 2006, http://www.gao.gov/docdblite/details.php?rptno=GAO-06-1003 ) revealed that, as of April 2006: (1) Emergency departments were experiencing overcrowding; but that (2) the number of staffed inpatient beds per 1,000 population was greater than that of the national average and expected to increase further. However, the study found that the number of staffed inpatient beds was not available in psychiatric care settings. In fact, some persons with mental health needs had to be transferred out of the area due to a lack of beds. Attracting and retaining nursing and support staff were two problems that were identified as hindering efforts to maintain an adequate supply of staffed beds for psychiatric patients. While this study focused specifically on patient care issues in the New Orleans area, the same issues are common to hospitals in any major metropolitan area. Given the vulnerability of persons with mental illness and the tremendous stress a man-made or natural disaster can put on the entire general population, an increase in the number of persons who seek mental health services and require inpatient psychiatric care can be expected following any natural or man-made disaster. In another report from the GAO, an after-event analysis entitled, “Disaster Recovery: Past Experiences Offer Recovery Lessons for Hurricane Ike and Gustav and Future Disasters,” (GAO-09-437T March 3, 2009, http://www.gao.gov/products/GAO-09-437T ) the GAO concluded that recovery from major disasters is a complex undertaking that involves the combined efforts of federal, state, and local government in order to succeed. The GAO stated that while the federal government provides a significant amount of financial and technical assistance for recovery, state and local jurisdictions should work closely with federal agencies to secure and make use of those resources. In a report from the GAO, entitled, “Influenza Pandemic: Gaps in Pandemic Planning and Preparedness Need to be Addressed,” (GAO-09-909T July 29, 2009; http://www.gao.gov/new.items/d09909t.pdf ), the GAO expressed its concern that, despite a number of actions having been taken to plan for a pandemic, including developing a National Strategy and Implementation Plan, many gaps in pandemic planning and preparedness still existed in the presence of a potential pandemic influenza outbreak. In November 2009, the GAO published an additional report entitled, “Influenza Pandemic: Monitoring and Assessing the Status of the National Pandemic Implementation Plan Needs Improvement,” (GAO-10-73) ( http://www.gao.gov/new.items/d1073.pdf ). In this report, the GAO assessed the progress of the responsible federal agencies (including HHS) in implementing the action items set forth in the “National Strategy for Pandemic Influenza: Implementation Plan” (the Plan) ( http://georgewbush-whitehouse.archives.gov/homeland/pandemic-influenza-implementation.html ). Specifically, the researchers were interested in determining how the Homeland Security Council (HSC) and the responsible federal agencies were monitoring the progress and completion of the Plan's 342 action items, and assessing the extent to which selected action items were completed, whether activity had continued on the selected action items reported as complete, and the nature of that work. Having conducted an in-depth analysis of a random sample of 60 action items, the GAO found the status of selected action items considered complete was difficult to determine. Specifically, the GAO found that: (1) Measures of performance used to determine status did not always fully reflect the descriptions of the action items; (2) some selected action items were designated as complete despite requiring actions outside the authority of the responsible entities; and (3) additional work was conducted on some selected action items designated as complete. Ultimately, the GAO recommended that, in order to improve how progress is monitored and completion is assessed under the Plan and subsequent updates of the Plan, the HSC should instruct the White House National Security Staff (NSS) to work with responsible federal agencies to: (1) Develop a monitoring and reporting process for action items that are intended for nonfederal entities, such as state and local governments; (2) identify the types of information needed to decide whether to carry out the response-related action items; and (3) develop measures of performance that are more consistent with the descriptions of the action items. C. Statutory and Regulatory Background Various sections of the Social Security Act (the Act) define the terms Medicare uses for each provider and supplier type and list the requirements that each provider and supplier must meet to be eligible for Medicare and Medicaid participation. Each statutory provision also specifies that the Secretary may establish other requirements as the Secretary finds necessary in the interest of the health and safety of patients, although the exact wording of such authority may differ slightly between different provider and supplier types. These requirements are called the Conditions of Participation (CoPs) for providers and the Conditions for Coverage (CfCs) for suppliers. The CoPs and CfCs are intended to protect public health and safety and ensure that high quality care is provided to all persons. Further, the Public Health Service (PHS) Act sets forth additional requirements that certain Medicare providers and suppliers must meet to participate. The following are the statutory and regulatory citations for the providers and suppliers for which we intend to propose emergency preparedness regulations: • Religious Nonmedical Health Care Institutions (RNHCIs)—section 1821 of the Act and 42 CFR 403.700 through 403.756. • Ambulatory Surgical Centers (ASCs)—section 1832(a)(2)(F)(i) of the Act and 42 CFR 416.40 through 416.49. • Hospices—section 1861(dd)(1) of the Act and 42 CFR 418.52 through 418.116. • Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs (PRTFs)—sections 1905(a) and 1905(h) of the Act and 42 CFR 441.150 through 441.182 and 42 CFR 483.350 through 483.376. • Programs of All-Inclusive Care for the Elderly (PACE)—sections 1894, 1905(a), and 1934 of the Act and 42 CFR 460.2 through 460.210. • Hospitals—section 1861(e)(9) of the Act and 42 CFR 482.1 through 482.66. • Transplant Centers—sections 1861(e)(9) and 1881(b)(1) of the Act and 42 CFR 482.68 through 482.104. • Long Term Care (LTC) Facilities -Skilled Nursing Facilities (SNFs) -under section 1819 of the Act, Nursing Facilities (NFs)—under section 1919 of the Act, and 42 CFR 483.1 through 483.180. • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID)—section 1905(d) of the Act and 42 CFR 483.400 through 483.480. • Home Health Agencies (HHAs)—sections 1861(o), 1891 of the Act and 42 CFR 484.1 through 484.55. • Comprehensive Outpatient Rehabilitation Facilities (CORFs)—section 1861(cc)(2) of the Act and 42 CFR 485.50 through 485.74. • Critical Access Hospitals (CAHs)—sections 1820 and 1861(mm) of the Act and 42 CFR 485.601 through 485.647. • Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services—section 1861(p) of the Act and 42 CFR 485.701 through 485.729. • Community Mental Health Centers (CMHCs)—section 1861(ff)(3)(B)(i)(ii) of the Act, section 1913(c)(1) of the PHS Act, and 42 CFR 410.110. • Organ Procurement Organizations (OPOs)—section 1138 of the Act and section 371 of the PHS Act and 42 CFR 486.301 through 486.348. • Rural Health Clinics (RHCs)—section 1861(aa) of the Act and 42 CFR 491.1 through 491.11; Federally Qualified Health Centers (FQHCs)—section 1861(aa) of the Act and 42 CFR 491.1 through 491.11, except 491.3. • End-Stage Renal Disease (ESRD) Facilities—sections 1881(b), 1881(c), 1881(f)(7) of the Act and 42 CFR 494.1 through 494.180. We considered proposing these regulations for each provider and supplier type individually, as we updated their CoPs or CfCs over time. However, for the reasons we have already discussed, we believe the most prudent course of action is to publish emergency preparedness requirements for Medicare and Medicaid providers and suppliers in a single proposed rule. Thus, we are proposing regulatory language for 17 Medicare and Medicaid providers and suppliers to address the four main aspects of emergency preparedness: (1) Risk assessment and planning; (2) policies and procedures; (3) communication; and (4) training. II. Provisions of the Proposed Regulations This proposed rule responds to concerns from the Congress, the health care community, and the public regarding the ability of health care providers and suppliers to plan and execute appropriate emergency response procedures for disasters. We developed this proposed rule taking into consideration the extent of regulatory oversight that is currently in existence. We are proposing requirements for facilities to ensure the continued provision of necessary care at the facility or, if needed, the evacuation and transfer of patients to a location that can supply necessary care. Regulations that address these functions too specifically may become outdated over time as technology and the nature of threats change. However, as our analysis of existing regulations, and the OIG and GAO reports discussed in section I. of this proposed rule, indicate regulations that are too broad may be ineffective. Our challenge is to develop core components that can be used across provider and supplier types as diverse as hospitals, organ procurement organizations, and home health agencies, while tailoring requirements for individual provider and supplier types to their specific needs and circumstances, as well as the needs of their patients, residents, clients, and participants. We have identified four core elements that we believe are central to an effective emergency preparedness system and must be addressed to offer a more comprehensive framework of emergency preparedness requirements for the various Medicare- and Medicaid-participating providers and suppliers. The four elements are—(1) risk assessment and planning; (2) policies and procedures; (3) communication; and (4) training and testing. We have also proposed an additional requirement for OPOs entitled “Agreements with other OPOs and hospitals.” We believe many of the proposed elements of an emergency preparedness plan need to be conducted at the level of an individual facility. However, other elements may be addressed as effectively, and more efficiently, at a broader organizational level, for example, a system for preserving medical documentation. Our regulatory requirements for each provider and supplier type are based on the comprehensive emergency preparedness requirements that we are proposing for hospitals. Since we are aware that the application of the proposed regulatory language for hospitals may be inappropriate or overly burdensome for some providers and suppliers, we have used the proposed hospital requirements as a template for our proposed emergency preparedness regulations for other providers and suppliers but have specific proposed requirements tailored to each providers' and suppliers' unique needs. Any contracted services furnished to patients must be in compliance with all the facilities' CoPs and standards of this rule, and all services must be provided in a safe and effective manner. All providers and suppliers would be required to establish an emergency preparedness plan that addressed the four core elements noted previously. The proposed requirements vary based on the type of provider. We discuss the hospital requirements in detail at the beginning of this section. The subsequent discussion of the proposed requirements for all remaining providers and suppliers focuses on how the requirements differ from those proposed for hospitals and why. For example, because they are inpatient facilities, religious nonmedical health care institutions (RNHCIs), psychiatric residential treatment facilities (PRTFs), skilled nursing facilities and nursing homes (referred to in this document as long term care (LTC) facilities), intermediate care facilities individuals with intellectual disabilities (ICFs/IID), and critical access hospitals (CAHs) may have greater responsibility than outpatient facilities during an emergency for ensuring the health and safety of persons for whom they provide care, their employees, and volunteers. Thus, proposed requirements for RNHCIs, PRTFs, ICFs/IID, LTC facilities, and CAHs are similar to those proposed for hospitals. In the event of a natural or man-made disaster, providers and suppliers of outpatient services, such as ambulatory surgical centers (ASCs), programs of all-inclusive care for the elderly (PACE) organizations, home health agencies (HHAs), comprehensive outpatient rehabilitation facilities (CORFs), rural health clinics (RHCs), federally qualified health centers (FQHCs), and end stage renal disease (ESRD) facilities, may not open their facilities or may close them, sending patients and staff home or to a place where they can safely shelter in place. However, we recognize that outpatient facilities may find it necessary to shelter their patients until they can be evacuated or may be called upon to provide some level of care for community residents in the event of an emergency. For example, a CORF that is housed in a large building may open its doors to persons in the community who would otherwise have no place to go. The CORF may provide only shelter from the elements or may provide water, food, and basic self-care items, if available. Finally, given that some hospice facilities provide both inpatient and home based services, and that transplant centers and OPOs are unique in their provision of health care, our proposed requirements are tailored even more specifically to address the circumstances of these entities. We believe lessons learned following the 2005 hurricanes and subsequent disasters, such as the flooding in the Midwest in 2008, and the tornadoes and flooding in 2011 and 2012, have provided us with an opportunity to work collaboratively with the health care community to ensure best practices in emergency preparedness across providers and suppliers. It is important to point out that we expect that implementation of certain requirements that we propose for providers and suppliers would be different, based on the category of the provider or supplier. For example, we propose that nearly all providers and suppliers would be required to have policies and procedures to provide subsistence needs to staff and patients during an emergency. However, a small RHC's implementation of this requirement would be quite different from a large metropolitan hospital's implementation. Specifically, with respect the proposed requirement that hospitals, CAHs, inpatient hospice facilities, PRTFs, LTC facilities, ICFs/IID, and RNHCIs would be required to maintain various subsistence needs, we are requesting public comment regarding whether this should be a requirement and in what quantities and for what time period these subsistence needs would be maintained. Nevertheless, we expect that each facility would determine how to implement a requirement considering similar variables such as whether the provider might have the option of notifying staff and patients not to come to the facility due to an emergency; the number of staff and patients likely to be in the facility at the time of an emergency; whether the provider would have the capability of providing shelter, provisions, and health care to members of the community; and the amount of space within the facility available for storing provisions. Although various providers and suppliers utilize different nomenclature to describe the individuals for whom they provide care (patient, resident, client, or participant), unless otherwise indicated, we will use the term “patients” to refer to the individuals for whom the provider or supplier under discussion provides care. Data regarding the number of providers cited in this proposed rule were obtained from a variety of different CMS databases. The number of providers and suppliers deemed by accrediting organizations to meet the Medicare conditions of participation are from CMS's second quarter fiscal year 2010 Accrediting Organization System for Storing User Recorded Experiences (ASSURE) database. Currently, there are accrediting organizations with Medicare deeming authority for hospitals, critical access hospitals, HHAs, hospices, and ASCs. Data for CAHs that report having psychiatric and rehabilitation Distinct Part Units (DPUs) are from the Medicare Quality Improvement and Evaluation System (QIES)/Certification and the Survey Provider Enhanced Reporting (CASPER) system as of March 2013. Data for CAHs that do not have DPUs are from the Online Survey, Certification, and Reporting (OSCAR) data system as of March 2013. Data for the number of transplant centers are from the CMS Web site as of March 2013. Data for the total number of accredited and non-accredited hospitals, HHAs, ASCs, hospices, RHNCHIs, PRTFs, SNFs, ICFs/IID, CORFs, OPOs, and RHCs/FQHCs are from the OSCAR data system as of March 2013. We acquired the PACE data from CMS's Health Plan Management System (HPMS), which reports the number of PACE contracts. Given that PACE organizations may have more than one “center,” we are using the number of PACE contracts as a reflection of the number of PACE centers under contract with the CMS. Note that the CMS OSCAR data system is updated periodically by the individual states. Due to variations in the timeliness of the data submissions, all numbers are approximate, and the number of accredited and non-accredited facilities shown may not equal the total number of facilities. Discussion of the proposed regulatory provisions for each type of provider and supplier follows the discussion in this section of the hospital requirements in the order in which they would appear in the Code of Federal Regulations (CFR). However, our discussion of the hospital requirements includes a general discussion of the differences between our proposed requirements, based on whether providers and suppliers provide outpatient services or inpatient services or both. Thus, we encourage all providers to read the discussion of the proposed hospital emergency preparedness requirements in section II.A. of this proposed rule. This section also provides detailed discussion of each proposed hospital requirement, offers resources that providers and suppliers can use to meet these proposed requirements, offers a means to establish and maintain emergency preparedness for their facilities, and provides links to guidance materials and toolkits that can be used to help meet these requirements. A. Emergency Preparedness Regulations for Hospitals (§ 482.15) Section 1861(e) of the Act defines the term “hospital” and subsections (1) through (8) list requirements that a hospital must meet to be eligible for Medicare participation. Section 1861(e)(9) of the Act specifies that a hospital must also meet such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services in the institution. Under the authority of 1861(e) of the Act, the Secretary has established in regulations at 42 CFR part 482 the requirements that a hospital must meet to participate in the Medicare program. Section 1905(a) of the Act provides that Medicaid payments may be applied to hospital services. Regulations at § 440.10(a)(3)(iii) require hospitals to meet the Medicare conditions of participation (CoPs) to qualify for participation in Medicaid. The hospital CoPs are found at § 482.1 through § 482.66. As of September 2012, 4,928 hospitals participated in Medicare. CAHs that have distinct part units (DPUs) must comply with all of the hospital CoPs with respect to those units. There are 1,332 active CAHs. Of these CAHs, there are 95 CAHs with DPUs. The remainder of CAHs (the vast majority) are not subject to hospital CoPs, and must comply with CAH-specific CoPs. Proposed requirements for CAHs are laid out in § 485.625. Services provided by hospitals encompass inpatient and outpatient care for persons with various acute or chronic medical or psychiatric conditions, including patient care services provided in the emergency department. Hospitals are the focal points for health care in their respective communities; thus, it is essential that hospitals have the capacity to respond in a timely and appropriate manner in the event of a natural or man-made disaster. Additionally, since Medicare-participating hospitals are required to evaluate and stabilize every patient seen in the emergency department and to evaluate every inpatient at discharge to determine his or her needs and to arrange for post-discharge care as needed, hospitals are in the best position to coordinate emergency preparedness planning with other providers and suppliers in their communities. We are proposing a new requirement under 42 CFR 482.15 that would require that hospitals have both an emergency preparedness program and an emergency preparedness plan. Conceptually, an emergency preparedness program encompasses an approach to emergency preparedness that allows for continuous building of a comprehensive system of health care response to a natural or man-made emergency. We are also proposing that a hospital, and all other providers and suppliers, utilize an “all-hazards” approach in the preparation and delivery of emergency preparedness services in order to meet the health and safety needs of its patient population. The definition of “all hazards” is discussed later in this section under “Emergency Plan.” We would expect that during an emergency, injured and ill individuals would seek health care services at a hospital or CAH, rather than from another provider or supplier. For example, during a pandemic, individuals with influenza-like symptoms are more likely to visit a hospital or CAH emergency department than an ASC. Typically, in the event of a chemical spill, affected individuals would not expect to receive emergency health care services at an LTC facility but would seek health care services at the hospital or CAH in their community. However, we believe it is imperative that each provider think in broader terms than their own facility, and plan for how they would serve similar and other healthcare facilities, as well as the whole community during and surrounding an emergency event. We believe the first step in emergency management is to develop an emergency plan. An emergency plan sets forth the actions for emergency response based on a risk assessment that addresses an “all-hazards approach” to medical and non-medical emergency events. In keeping with the emergency management industry and with strong recommendation from the Department's Assistant Secretary for Preparedness and Response (ASPR), we are proposing that all providers utilize an all-hazards approach to emergency response. We do not specify the quantity or the expected level of detail in which each hazard would be addressed by each provider; however, we do believe it would encourage the adoption of a well thought out, cohesive system of response both within and across provider types. Analysis of anticipated outcomes to the facility-based and community-based risk assessments would drive revision to the emergency preparedness program, the plan for response, or both. A facility-based risk assessment is contained within the actual facility and carried out by the facility. A community based risk assessment is carried out outside the organization within their defined community. 1. Emergency Plan a. Emergency Planning Resources To stimulate and foster improved emergency preparedness continuity of operations, the federal interagency community has developed fifteen all-hazards planning scenarios, entitled the “National Planning Scenarios” for use in federal, state, and local homeland security preparedness activities. These scenarios serve as planning tools for response to the range of man-made and natural disasters the nation could face. The scenarios are: nuclear detonation-improvised nuclear device; biological attack—aerosol anthrax; biological disease outbreak—pandemic influenza; biological attack—plague; chemical attack—blister agent; chemical attack—toxic industrial chemicals; chemical attack—nerve agent; chemical attack—chlorine tank explosion; natural disaster—major earthquake; and natural disaster—major hurricane; radiological attack—radiological dispersal devices; explosive attack—bombing using improvised explosive device; biological attack—food contamination; biological attack—foreign animal disease (foot and mouth disease); and cyber attack. Additional scenarios include volcano preparedness and severe winter weather (snow/ice). Additional information regarding the National Planning Scenarios and how they align to the National Preparedness Goal can be found at: http://www.fema.gov/preparedness-1/learn-about-presidential-policy-directive-8#MajorElements. These planning tools along with other emergency management and business continuity information can be found on HRSA's Web site at: http://www.hrsa.gov/emergency/ and also in HRSA's, Policy Information Notice entitled, “Health Center Emergency Management Program Expectations,” (No. 2007-15), dated August 22, 2007, at: http://bphc.hrsa.gov/policiesregulations/policies/pin200715expectations.html ). While these materials were developed for health centers, the content is relevant to all health providers. According to the notice emergency management planning is to ensure predictable staff behavior during a crisis, provide specific guidelines and procedures to follow and define specific roles. Also, emergency planning should address the four phases of emergency management that include: mitigation activities to lessen the severity and impact a potential disaster or emergency might have on a health center's operation; preparedness activities to build capacity and identify resources that may be used should a disaster or emergency occur; response to the actual emergency and controls the negative effects of emergency situations; and recovery that begin almost concurrently with response activities and are directed at restoring essential services and resuming normal operations to sustain the long-term viability of the health center. HRSA further states that for FQHCs, this means protecting staff and patients, as well as safeguarding the facility's ability to deliver health care. According to HRSA, the expectations outlined in their guidance are intended to be broad to ensure applicability to the diverse range of centers and to aid integration of the guidance into what centers already are doing related to emergency and risk management. While this guidance is targeted toward centers, we believe hospitals and all other providers and suppliers can use this guidance in the development of their emergency preparedness plans. The Agency for Healthcare Research and Quality (AHRQ) released a web-based interactive tool entitled, “Surge Tool Kit and Facility Checklist” (located at: http://www.cdc.gov/phpr/healthcare/documents/shuttools.pdf or at: http://archive.ahrq.gov/research/shuttered/toolkitchecklist/ ), which will allow hospitals and emergency planners to estimate the resources needed to treat a surge of patients resulting from a major disaster, such as an influenza pandemic or a terrorist attack. Designed to dovetail with the Homeland Security Council's 15 all-hazards National Planning Scenarios, previously discussed, the AHRQ Hospital Surge Model allows users to select a disaster scenario and estimate the number of patients needing medical attention by arrival condition and day; the number of casualties in the hospital by unit and day; and the cumulative number of both dead or discharged casualties by day. The tool also calculates the level of hospital resources, including personnel, equipment and supplies, needed to treat patients. The model estimates resources for biological, chemical, nuclear or radiological attacks. (For the development of emergency preparedness plans, providers and suppliers may also find the National Fire Protection Association's (NFPA) NFPA 1600: “Standard on Disaster/Emergency Management and Business Continuity Programs, 2013 Edition,” particularly helpful. The NFPA document can be found at: http://www.nfpa.org/aboutthecodes/AboutTheCodes.asp?DocNum=1600. The standard sets forth the basic criteria for a comprehensive program that addresses disaster recovery, emergency management, and business continuity. Under most definitions, the NFPA 1600 is an industry standard for disaster management. Also of concern when developing an emergency plan is the issue of the allocation of scarce resources during a potentially devastating event. Disasters can create situations where such resources must be distributed in a manner that is different from usual circumstances, but still appropriate to the situation. As discussed in “Providing Mass Medical Care with Scarce Resources: A Community Planning Guide, Publication No. 07-0001, Rockville, MD: Agency for Healthcare Research and Quality,” (found at: http://archive.ahrq.gov/research/mce/ ), such resource considerations are part of the impact that natural or man-made disasters have on hospitals. This guide provides information on the circumstances that communities would likely face as a result of a mass casualty event (MCE); key constructs, principles, and structures to be incorporated into the planning for an MCE; approaches and strategies that could be used to provide the most appropriate standards of care possible under the circumstances; examples of tools and resources available to help states and communities in their planning processes; and illustrative examples of how some health systems, communities, or states have approached certain issues as part of their MCE-related planning efforts. Building on the work from 2008, the Institute of Medicine (IOM) released in 2012 a guidance report entitled “The Crisis Standards of Care (CSC): A Systems Framework for Catastrophic Disaster Response” available at: http://www.iom.edu/Reports/2012/Crisis-Standards-of-Care-A-Systems-Framework-for-Catastrophic-Disaster-Response.aspx . The guidance report expanding upon prior scarce resources reports and defined crisis standards of care as “the optimal level of health care that can be delivered during a catastrophic event, requiring a substantial change in usual health care operations.” The report stated that CSC; provides a mechanism for responding to situations in which the demand on needed resources far exceeds the resource availability (that is, scarce resources); implementation of CSC involves a substantial shift in normal health care activities and reallocation of staff, facilities, and resources; and that to transition quickly and effectively, each organization and agency has a responsibility to plan and identify in advance the core functions it must carry out in a crisis and who will be responsible for each task. Another resource that would be useful in helping planners address the issues associated with preparing for and responding to an MCE in the context of broader emergency planning processes is the document entitled, “Standing Together: An Emergency Planning Guide for America's Communities” (published by The Joint Commission (TJC), formerly known as the Joint Commission on the Accreditation of Healthcare Organizations, 2006). The document by TJC is a comprehensive resource that offers step-by-step guidance for development of an emergency preparedness plan that is applicable to small, rural, and suburban communities. This document can be found at: http://www.jointcommission.org/Standing_Together__An_Emergency_Planning_Guide_for_Americas_Communities/. This document may be particularly useful for small or rural facilities and agencies. Rural communities face challenges in the delivery of health care that are often very different from those faced by urban and suburban communities. While rural communities depend on public health departments, hospitals, and emergency medical services (EMS) providers just as urban and suburban communities do, rural communities tend to have fewer health care resources overall. A report entitled, “Rural Communities and Emergency Preparedness,” (published by the Health Resources and Services Administration's (HRSA) Office of Rural Health Policy, April 2002, found at: ftp://ftp.hrsa.gov/ruralhealth/RuralPreparedness.pdf ) addresses the issues faced by rural communities with respect to emergency preparedness. The authors report that there are many factors that limit the ability of rural providers and suppliers to deliver optimal health care services in the event of a natural or man-made disaster. The authors found that geographic isolation is a significant barrier to providing a coordinated emergency response. Rural areas are also more affected by variations in weather conditions and by seasonal variations in populations (for instance, tourism). As reported by the authors, these areas have fewer human and technical resources (that is, health care professionals, medical equipment, and communication systems). For example, the study found that in 2002, only 20 percent of the 3,000 local public health departments in the United States had developed a plan to deal with a bioterrorism event. The researchers also found that the majority of rural public health agencies are closed evenings and weekends, and are not equipped to respond to an emergency situation on a 24-hour basis. While these factors may not affect a rural hospital directly, as an integral part of the larger system of health care delivery for its community, a hospital must be ready to manage the surge of persons who would seek care at the hospital during and after a disaster when many smaller health care entities may be non-operational. b. Risk Assessment To ensure that all hospitals operate as part of a coordinated emergency preparedness system, as outlined in the PPD-8, NIMS, NRF, HSPD-21, and PAHPA/PAHPRA, we are proposing at § 482.15 that all hospitals establish and maintain an emergency preparedness plan that complies with both federal and state requirements. Additionally, we propose that a hospital would develop and maintain a comprehensive emergency preparedness program, utilizing an “all-hazards” approach. The emergency preparedness plan would have to be reviewed and updated at least annually. In keeping with the focus of the emergency management field, we propose that prior to establishing an emergency preparedness plan, the hospital and all other providers would first perform a risk assessment based on utilizing an “all-hazards” approach. An all-hazards approach is an integrated approach to emergency preparedness planning. In the abstract of a November 2007 paper entitled, “Universal Design: The All-Hazards Approach to Vulnerable Populations Planning” by Charles K.T. Ishikawa, MSPH, Garrett W. Simonsen, MSPS, Barbara Ceconi, MSW, and Kurt Kuss, MSW, the researchers described an all-hazards planning approach as “a more efficient and effective way to prepare for emergencies. Rather than managing planning initiatives for a multitude of threat scenarios, all-hazards planning focuses on developing capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters.” Thus, all-hazards planning does not specifically address every possible threat but ensures that hospitals and all other providers will have the capacity to address a broad range of related emergencies. It is imperative that hospitals perform all-hazards risk assessment consistent with the concepts outlined in the National Preparedness Guidelines, the “Guidelines” published by the U.S. Department of Homeland Security that we described in section I.A.3 of this proposed rule. Additional guidance and resources for assistance with designing and performing a hazard vulnerability assessment include: the Comprehensive Preparedness Guide 201: Threat and Hazard Identification and Risk Assessment Guide (available at: http://www.fema.gov/library/viewRecord.do?fromSearch=fromsearch&id=5823 ), the Use of Threat and Hazard Identification and Risk Assessment for Preparedness Grants (available at: http://www.fema.gov/library/viewRecord.do?fromSearch=fromsearch&id=5826 ), the Preparedness Guide 201 Supplement 1: Threat and Hazard Identification and Risk Assessment Guide Toolkit (available at: http://www.fema.gov/library/viewRecord.do?fromSearch=fromsearch&id=5825 ), the Hazard Risk Assessment Instrument Workbook (available at: http://www.cphd.ucla.edu/hrai.html ) and the Understanding Your Risks: Identifying Hazards and Estimating Losses document (available at: http://www.fema.gov/library/viewRecord.do?id=1880 ). Additionally, AHRQ published two additional guides to help hospital planners and administrators make important decisions about how to protect patients and health care workers and assess the physical components of a hospital when a natural or manmade disaster, terrorist attack, or other catastrophic event threatens the soundness of a facility. The guides examine how hospital personnel have coped under emergency situations in the past to better understand what factors should be considered when making evacuation, shelter-in-place, and reoccupation decisions. The guides entitled, “Hospital Evacuation Decision Guide” and “Hospital Assessment and Recovery Guide” are intended to supplement hospital emergency plans, augment guidance on determining how long a decision to evacuate may be safely deferred, and provide guidance on how to organize an initial assessment of a hospital to determine when it is safe to return after an evacuation. The evacuation guide distinguishes between “pre-event evacuations” which are undertaken in advance of an impending disaster, such as a storm, when the hospital structure and surrounding environment are not yet significantly compromised and “post-event evacuations,” which are carried out after a disaster has damaged a hospital or the surrounding community. It draws upon past events including: the Northridge, CA, earthquake of 1994; the Three Mile Island nuclear reactor incident of 1979; and Hurricanes Katrina and Rita in 2005. The guide offers advice regarding sequence of patient evacuation and factors to consider when a threat looms. The assessment and recovery guide helps hospitals determine when to get back into a hospital after an evacuation. Comprised primarily of a 45-page checklist, the guide covers 11 separate areas of hospital infrastructure that should be evaluated before determining that it is safe to reoccupy a facility, such as security and fire safety, information technology and communication and biomedical engineering. The “Hospital Evacuation Decision Guide” can be found at: http://archive.ahrq.gov/prep/hospevacguide/ ) (AHRQ Publication No. 10-0009), and the “ Hospital Assessment and Recovery Guide” can be found at ( http://archive.ahrq.gov/prep/hosprecovery/ ) (AHRQ Publication No. 10-0081). Based on the guidance and information in these resources, we would expect a hospital's risk assessment, which we would require at § 482.15(a)(1), to be based on and include a documented, facility-based and community-based risk assessment, utilizing an all hazards approach. In order to meet this requirement, we would expect hospitals to consider, among other things, the following—(1) Identification of all business functions essential to the hospitals operations that should be continued during an emergency; (2) identification of all risks or emergencies that the hospital may reasonably expect to confront; (3) identification of all contingencies for which the hospital should plan; (4) consideration of the hospital's location, including all locations where the hospital delivers patient care or services or has business operations; (5) assessment of the extent to which natural or man-made emergencies may cause the hospital to cease or limit operations; and (6) determination of whether arrangements with other hospitals, other health care providers or suppliers, or other entities might be needed to ensure that essential services could be provided during an emergency. We propose at § 482.15(a)(2) that the emergency plan include strategies for addressing emergency events identified by the risk assessment. For example, a hospital in a large metropolitan city may plan to utilize the support of other large community hospitals as alternate placement sites for its patients if the hospital needs to be evacuated. However, we would expect the hospital to have back-up evacuation plans for circumstances in which nearby hospitals also were affected by the emergency and were unable to receive patients. We would expect these plans to include consideration for how the hospital would work in collaboration with hospitals and other providers and suppliers across state lines, if applicable. Individuals who live near the border with an adjoining state could use the services of a hospital located in the adjoining state if the hospital was closer or provided more services than the nearest hospital in the state in which the individual resides. Therefore, we would encourage hospitals in adjoining states to work together to formulate plans to provide services across state lines in the event of a natural or man-made disaster to ensure continuity of care during a disaster. c. Patient Population and Available Services At § 482.15(a)(3), we propose that a hospital's emergency plan address its patient population, including, but not limited to, persons at-risk. As defined by the PAHPA, members of at-risk populations may have additional needs in one or more of the following functional areas: maintaining independence, communication, transportation, supervision, and medical care. In addition to those individuals specifically recognized as at-risk in the statute (children, senior citizens, and pregnant women), we are proposing to define “at-risk populations” as individuals who may need additional response assistance including those who have disabilities, live in institutionalized settings, are from diverse cultures, have limited English proficiency or are non-English speaking, lack transportation, have chronic medical disorders, or have pharmacological dependency. Also, as discussed in “Providing Mass Medical Care with Scarce Resources: A Community Planning Guide,” ( http://archive.ahrq.gov/research/mce/ ), at-risk populations would include, but are not limited to, the elderly, persons in hospitals and nursing homes, people with physical and mental disabilities, and infants, and children. Hospitals may find this resource helpful in establishing emergency plans that address the needs of such patients. We also propose at § 482.15(a)(3) that a hospital's emergency plan address the types of services that the hospital would be able to provide in an emergency. The hospital should base these determinations on factors such as the number of staffed beds, whether the hospital has an emergency department or trauma center, availability of staffing and medical supplies, the hospital's location, and its ability to collaborate with other community resources during an emergency. d. Succession Planning and Cooperative Efforts In regard to emergency preparedness planning, we are also proposing at § 482.15(a)(3) that all hospitals include delegations and succession planning in their emergency plan to ensure that the lines of authority during an emergency are clear and that the plan is implemented promptly and appropriately. Finally, at § 482.15(a)(4), we propose that a hospital have a process for ensuring cooperation and collaboration with local, tribal, regional, state, or federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the hospital's efforts to contact such officials and, when applicable, its participation in collaborative and cooperative planning efforts. We believe that planning with officials in advance of an emergency to determine how such collaborative and cooperative efforts will be achieved will foster a smoother, more effective, and more efficient response in the event of a disaster. While we are aware that the responsibility for ensuring a coordinated disaster preparedness response lies upon the state and local emergency planning authorities, the hospital would need to document its efforts to contact these officials and inform them of the hospital's participation in the coordinated emergency response. Although we propose to require the same efforts for all providers and suppliers as we propose for hospitals, we realize that federal, state, and local officials may not elect to collaborate with some providers and suppliers due to their size and role in the community. For example, a RNHCI, by the limited nature of its service within the community, may not be called upon to participate in such collaborative and cooperative planning efforts. In this instance, we are proposing that such a provider or supplier would only need to provide documentation of its efforts to contact such officials and, when applicable, its participation. Through the work of its state partners, the ASPR Hospital Preparedness Program (HPP) has advanced the preparedness of hospitals and communities in numerous ways, including building healthcare coalitions, planning for all hazards, increasing surge capacity, tracking the availability of beds and other resources using electronic systems, and developing communication systems that are interoperable with other response partners. Many more community healthcare facilities have equipment to protect healthcare workers and decontaminate patients in chemical, biological, radiological, or nuclear emergencies. While the HPP program continues to encourage preparedness at the hospital level, evidence and real-world events have illustrated that hospitals cannot be successful in response without robust community healthcare coalition preparedness—engaging critical partners. Critical partners include emergency management, public health, mental/behavioral health providers, as well as community and faith-based partners. Together these partners make up a community's Healthcare Coalition (HCC). A key goal of HPP moving forward is to strengthen the capabilities of the HCC, not just the individual hospital. HCCs are a cornerstone for the HPP and an integral component for community-wide planning for healthcare resiliency. We are aware that, among some emergency management leaders, healthcare coalitions are viewed as a valued and essential component of a coordinated system of response and that many providers now participate in such coalitions. While we are not requiring that providers participate in coalitions, we do recognize and support their value in the well-coordinated emergency response system and encourage providers of all types and sizes to engage in such collaborations, where possible, to ensure better coordination in planning, including the assessment of risk, surrounding an emergency event. The primary goal of health care coalitions is to foster collaboration amongst provider types in order to strengthen the overall health system by leveraging expertise, sharing resources, and increasing capacity to respond; thus reducing potential administrative burden for emergency preparedness, while similarly enabling easier emergency response integration and coordination during an emergency. Healthcare coalition activities provide, at a minimum, an optimal forum for: Leveraging leadership and operational expertise (health, public health, emergency management, public works, public safety, etc.) within a community; conducting mutual hazard vulnerability/risk assessments to identify community health gaps and develop plans and strategies to address them; developing standardized tools, emergency plans, processes and protocols, training and exercises to support the community and support ease of integration; and facilitating timely and/or shared resource management and coordination of communications and information during an emergency 2. Policies and Procedures We are proposing at § 482.15(b) that a hospital be required to develop and implement emergency preparedness policies and procedures based on the emergency plan proposed at § 482.15(a), the risk assessment proposed at § 482.15(a)(1), and the communication plan proposed at § 482.15(c). These policies and procedures would be reviewed and updated at least annually. We are soliciting public comment on the timing of the updates. We propose at § 482.15(b)(1) that a hospital's policies and procedures would have to address the provision of subsistence needs for staff and patients, whether they evacuated or sheltered in place, including, but not limited to, at (b)(1)(i), food, water, and medical supplies. Analysis of the disaster caused by the hurricanes in the Gulf states in 2005 revealed that hospitals were forced to meet basic subsistence needs for community evacuees, including visitors and volunteers who sheltered in place, resulting in the rapid depletion of subsistence items and considerable difficulty in meeting the subsistence needs of patients and staff. Therefore, we are proposing that a hospital's policies and procedures also address how the subsistence needs of patients and staff who were evacuated would be met during an emergency. For example, a hospital might arrange for storage of supplies outside the facility, have contracts with suppliers for the acquisition of supplies during an emergency, or address subsistence needs for evacuees in an agreement with a facility that was willing to accept the hospital's patients during an emergency. Based on our experience with hospitals, most hospitals do maintain subsistence supplies in the event of an emergency. Thus, we believe it would be overly prescriptive to require hospitals to maintain a defined quantity of subsistence needs for a defined period of time. We believe hospitals and other inpatient providers should have the flexibility to determine what is adequate based on the location and individual characteristics of the facility. Although we propose requiring only that each hospital addresses subsistence needs for staff and patients, we recommend that hospitals keep in mind that volunteers, visitors, and individuals from the community may arrive at the hospital to offer assistance or seek shelter and consider whether the hospital needs to maintain a store of extra provisions. We are soliciting public comment on this proposed requirement. As stated earlier, we also have learned from attendance in the Hurricane Katrina Sharing Information During Emergencies (SIDE) conference held in July of 2006, and from on-going participation in the CMS Survey & Certification (S&C) Emergency Preparedness Stakeholder Communication Forum, that many facilities placed back-up generators in basements that subsequently became inoperable due to water damage. In turn, this led to possible unsafe conditions for their patients and other persons sheltered in the facility. We note that existing regulations at § 482.41 require hospitals to have emergency power and lighting in certain areas (operating, recovery, intensive care, emergency rooms, and stairwells). Emergency lighting only in these areas will not assist staff if there is a requirement to continue operations for long periods of time with no power (for example, in the wards). Power outages lasted several days after Hurricane Sandy in some areas of the northeast. Similarly, should a large-scale evacuation be required, a lack of emergency lighting in general areas of the hospital such as wards and corridors would greatly hinder this process. This was of particular concern in impacted healthcare facilities during Hurricane Sandy (Redlener I, Reilly M, Lessons from Sandy—Preparing Health Systems for Future Disasters. N ENGL J MED. 367;24:2269-2271.) Thus, as previously stated, at § 482.15(b)(1)(ii) we also propose that the hospital have policies and procedures that address the provision of alternate sources of energy to maintain: (1) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions; (2) emergency lighting; (3) fire detection, extinguishing, and alarm systems. We are also proposing at § 482.15(b)(1)(ii)(D) that the hospital develop policies and procedures to address provision of sewage and waste disposal. We are proposing to define the term “waste” as including all wastes including solid waste, recyclables, chemical, biomedical waste and wastewater, including sewage. These proposed requirements concern assuring the continuity of the power source for the fire detection, extinguishing and alarm systems and are an essential prerequisite for successful implementation of existing requirements during emergencies that result in loss of regular power. These proposed requirements are more in line with best practice rather than mere sufficiency. We are proposing at § 482.15(b)(2) that the hospital develop policies and procedures regarding a system to track the location of staff and patients in the hospital's care both during and after an emergency. We believe it is imperative that the hospital be able to track a patient's whereabouts, to ensure adequate sharing of patient information with other providers and to inform a patient's relatives and friends of the patient's location within the hospital, whether the patient has been transferred to another facility, or what is planned in respect to such actions. Therefore, we believe that hospitals must develop a means to track patients, which would include evacuees in the hospital's care during and after an emergency event. ASPR has developed tools, programs and resources to facilitate disaster preparedness planning at the local healthcare facility-level. One of these tools, The Joint Patient Assessment and Tracking System (JPATS), was developed through an interagency association between HHS/ASPR and DoD, and is available for providers at: https://asprwebapps.hhs.gov/jpats/protected/home.do. Use of the JPATS is referenced in Health Preparedness Capabilities: National Guidance for Health System Preparedness (2012). This document provides guidance for healthcare systems, healthcare coalitions and healthcare organizations emergency preparedness efforts that is intended to serve as a planning resource. Broad guidance as to the requirement for bed and patient tracking is included. Given the lessons learned, this requirement is being proposed for providers and suppliers who provide ongoing care to inpatients or outpatients. Such providers and suppliers would include RNHCIs, hospices, PRTFs, PACE organizations, LTC facilities, ICFs/IID, HHAs, CAHs, and ESRD facilities. Despite providing services on an outpatient basis, we would require hospices, HHAs, and ESRD facilities to assume this responsibility. These providers and suppliers maintain current patient census information and would be required to provide continuing patient care during the emergency. In addition, we would require ASCs to maintain responsibility for their staff and patients if patients were in the facility. Other outpatient providers, such as CORFs, FQHCs and clinics maintain patient information but they have the flexibility of cancelling appointments during an emergency thereby not needing to assume responsibility of the patients. This requirement is not being proposed for transplant centers; CORFs; OPOs; clinics, rehabilitation agencies as providers of outpatient physical therapy and speech-language pathology services; and RHCs/FQHCs. Transplant centers' patients and OPOs' potential donors would be in hospitals, and, thus, would be the hospital's responsibility. We believe it is likely that outpatient providers and suppliers would close their facilities prior to or immediately after an emergency, sending staff and patients home. We are not proposing a requirement for a specific type of tracking system. A hospital would have the flexibility to determine how best to track patients and staff, whether it used an electronic database, hard copy documentation, or some other method. However, it is important that the information be readily available, accurate, and shareable among officials within and across the emergency response system as needed in the interest of the patient. A number of states already have such tracking systems in place or under development and the systems are available for use by health care providers and suppliers. Lessons learned from the hurricanes in the Gulf States revealed that some facilities, despite having patient-related information backed up to computer databases within or outside of the state in which the disaster occurred, could not access the information in a timely manner. Therefore, we would recommend that a hospital using an electronic database consider backing up its computer system with a secondary source. Although we believe that it is important that a hospital, and other providers of critical care, be able to track a patient's whereabouts to ensure adequate sharing of patient information with other providers and to inform a patient's relatives of the patient's location after a disaster, we are specifically soliciting comments on the feasibility of this requirement for any outpatient facilities. We propose at § 482.15(b)(3) that hospitals have policies and procedures in place to ensure the safe evacuation from the hospital, which would include standards addressing consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. We propose at § 482.15(b)(4) that a hospital must have policies and procedures to address a means to shelter in place for patients, staff, and volunteers who remain in the facility. We expect that hospitals would include in their policies and procedures both the criteria for selecting patients and staff that would be sheltered in place and a description of the means that they would use to ensure their safety. During the Gulf Coast hurricanes, some hospitals were able to shelter their patients and staff in place. However, the physical structures of many other hospitals were so damaged that sheltering in place was impossible. Thus, when developing policies and procedures for sheltering in place, hospitals should consider the ability of their building(s) to survive a disaster and what proactive steps they could take prior to an emergency to facilitate sheltering in place or transferring of patients to alternate settings if their facilities were affected by the emergency. We propose at § 482.15(b)(5) that a hospital have policies and procedures that would require a system of medical documentation that would preserve patient information, protect the confidentiality of patient information, and ensure that patient records were secure and readily available during an emergency. In addition to the current hospital requirements for medical records located at § 482.24(b), we are proposing that hospitals be required to ensure that patient records are secure and readily available during an emergency. Such policies and procedures would have to be in compliance with Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulations at 45 CFR parts 160 and 164, which protect the privacy and security of individual's personal health information. Information on how HIPAA requirements can be met for purposes of emergency preparedness and response can be found at: http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/index.html. The tornadoes that occurred in Joplin, Missouri in 2011, presented an example of the value of electronic health records during a disaster. There were primary care clinics and other providers that had electronic health records and because their records were not destroyed, they were able to find new locations, contact their patients and re-establish operations very quickly. We propose at § 482.15(b)(6) that facilities would have to have policies and procedures in place to address the use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of state or federally designated health care professionals to address surge needs during an emergency. Facilities may find it helpful to utilize assistance from the Medical Reserve Corps (MRC), a national network of community-based volunteer units that focus on improving the health, safety and resiliency of their local communities. MRC units organize and utilize public health, medical and other volunteers to support existing local agencies with public health activities throughout the year and with preparedness and response activities for times of need. One goal of the MRC is to ensure that members are identified, screened, trained and prepared prior to their participation in any activity. While MRC units are principally focused on their local communities, they have the potential to provide assistance in a statewide or national disaster as well. Hospitals could use the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP), found in section 107 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188), to verify the credentials of volunteer health care workers. The ESAR-VHP is a federal program to establish and implement guidelines and standards for the registration, credentialing, and deployment of medical professionals in the event of a large-scale national emergency. The program is administered by ASPR within the Department. All states must participate in ESAR-VHP. The purpose of the program is to facilitate the use of volunteers at all tiers of response (local, regional, state, interstate, and federal). The ESAR-VHP program has been working to establish a national network of state-based programs that manage the information needed to effectively use health professional volunteers in an emergency. These state-based systems will provide up-to-date information regarding the volunteer's identity and credentials to hospitals and other health care facilities in need of the volunteer's services. Each state's ESAR-VHP system is built to standards that will allow quick and easy exchange of health professionals with other states. We propose at § 482.15(b)(7) that hospitals would have to have a process for the development of arrangements with other hospitals and other providers to receive patients in the event of limitations or cessation of operations at their facilities, to ensure the continuity of services to hospital patients. We believe this requirement should apply only to providers and suppliers that provide continuous care and services for individual patients. Thus, we are not proposing this requirement for transplant centers; CORFs; OPOs; clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services; and RHCs/FQHCs. We also propose at § 482.15(b)(8) that hospital policies and procedures would have to address the role of the hospital under a waiver declared by the Secretary, in accordance with section 1135 of the Act, for the provision of care and treatment at an alternate care site (ACS) identified by emergency management officials. We propose this requirement for inpatient providers only. We would expect that state or local emergency management officials might designate such alternate sites, and would plan jointly with local providers on issues related to staffing, equipment and supplies at such alternate sites. This requirement encourages providers to collaborate with their local emergency officials in such proactive planning to allow an organized and systematic response to assure continuity of care even when services at their facilities have been severely disrupted. Under section 1135 of the Act, the Secretary is authorized to temporarily waive or modify certain Medicare, Medicaid, and Children's Health Insurance Program (CHIP) requirements for health care providers to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in these programs in an emergency area (or portion of such an area) during any portion of an emergency period. Under an 1135 waiver, health care providers unable to comply with one or more waiver-eligible requirements may be reimbursed and exempted from sanctions (absent any determination of fraud or abuse). Requirements to which an 1135 waiver may apply include Medicare conditions of participation or conditions for coverage and requirements under the Emergency Medical Treatment and Labor Act (EMTALA). The 1135 waiver authority applies only to specific federal requirements and does not apply to any state requirements, including licensure. In determining whether to invoke an 1135 waiver (once the conditions precedent to the authority's exercise have been met), the ASPR with input from relevant HHS operating divisions (OPDIVs) determines the need and scope for such modifications, considers information such as requests from Governor's offices, feedback from individual healthcare providers and associations, and requests from regional or field offices for assistance. Additional information regarding the 1135 waiver process is provided in the CMS Survey and Certification document entitled, “Requesting an 1135 Waiver”, and located at: http://www.cms.gov/About-CMS/Agency-Information/H1N1/downloads/requestingawaiver101.pdf. Providers must resume compliance with normal rules and regulations as soon as they are able to do so. Waivers or modifications permitted under an 1135 waiver are no longer available after the termination of the emergency period. Generally, federally certified or approved providers must operate under normal rules and regulations, unless they have sought and have been granted modifications under the waiver authority from specific requirements. When a waiver has been issued under section 1135(b)(3) of the Act, EMTALA sanctions do not apply to a hospital with a dedicated emergency department, providing the conditions at § 489.24(a)(2)(i) are met. The EMTALA part of the 1135 waiver only applies for a 72-hour period, unless the emergency involves a pandemic infectious disease situation (see 42 CFR 489.24(a)(2)(ii)). Further information on the 1135 waiver process can be found at: http://www.cms.hhs.gov/H1N1/. Once an 1135 waiver is authorized, health care providers and suppliers can submit requests to operate under that authority to the CMS Regional Office, with a copy to the State Survey Agency. The Regional Office or State Survey Agency may also be able to help providers and suppliers identify other relief that may be possible and which does not require an 1135 waiver. This proposed requirement would be consistent with the ASPR's expectation that hospital grant awardees will continue to develop and improve their (ACS) plans and concept of operations for providing supplemental surge capacity within the health care syst [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2013-30724. Public record. Not legal advice.