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 & Me dicaid Services (CMS), HHS.

ACTION: Proposed rule.

SUMMARY: This proposed rule would establish national emergency preparedness requirements for Medicare- and Medicaid-participa ting 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 disaster s 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 type s of providers and suppliers, we are also proposing variations in these requirements. Thes e variations are based on existing statutory and regulatory policies and differing needs of each provi der or supplier type and the individuals to whom they provide health care services. Despite these variat ions, our proposed regulations would provide generally consistent emergency pr eparedness requirements, enhance patient safety2

during emergencies for persons served by Medica re- and Medicaid-particip ating facilities, and

establish a more coordinated and defined res ponse to natural and man-made disasters.

DATES : To be assured consideration, comments mu st be received at one of the addresses provided below, no later than 5 p.m. on [ O F R

- - i n s e r t d a t e 6 0 d a y s a f t e r d a t e o f p ub l i c a t i o n i n t h e Federal Register]

. ADDRESSES: In commenting, please refer to file code CMS-3178-P. Because of staff and resource limitations, we ca nnot 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 th e "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,3

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 prio r 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 Hube rt 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 stampin clock is available for persons wishing to reta in a proof of filing by st amping 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.4

Comments erroneously mailed to the addres ses indicated as appr opriate for hand or courier delivery may be delayed a nd received after the comment period. For information on viewing public co mments, 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, includi ng any personally identif iable 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 si te as soon as possible after they have been received: http://www.regulations.go v. Follow the search instructions on that Web site to view public comments. Comments received timely will also be av ailable for public inspection as they are received, generally beginning approximately 3 w eeks 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 1-800-743-3951.5

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 Commissi on 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 fo r Preparedness and Response

BLS Bureau of Labor Statistics BTCDP Bioterrorism Training and Curriculum Development Program CAH Critical Access Hospital CAMCAH Comprehensive Accreditation Ma nual for Critical Access Hospitals CAMH Comprehensive Accreditation Manual for Hospitals

CASPER Certification and the Surv ey 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 Information6

COP Conditions of Participation CORF Comprehensive Outpatie nt 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 Faciliti es Accreditation Program HHA Home Health Agencies HPP Hospital Preparedness Program

HRSA Health Resources and Services Administration HSC Homeland Security Council7

HSEEP Homeland Security Exer cise 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 Accredita tion 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 Framework8

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 a nd 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 Resident ial 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 Facility9

SNS Strategic National Stockpile TEFRA Tax Equity and Fi scal 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 Regul ations for Hospitals (§ 482.15) 1. Emergency plan a. Emergency Planning Resources10

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 fo r 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 Disabi lities (ICF/IID) (§ 483.475) J. Emergency Preparedness Regulations fo r Home Health Agencies (HHAs) (§ 484.22) K. Emergency Preparedness Regulations fo r Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§ 485.68)11

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 Outp atient 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 fo r 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 Particip ation: Emergency Preparedness (§ 403.748) D. ICRs Regarding Condition for Covera ge: Emergency Preparedness (§ 416.54) E. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§418.113) F. ICRs Regarding Emer gency Preparedness (§441.184) G. ICRs Regarding Emer gency Preparedness (§460.84) H. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 482.15)12

I. ICRs Regarding Condition of Participati on: Emergency Preparedness for Transplant Centers (§ 482.78) J. ICRs Regarding Emerge ncy Preparedness (§ 483.73) K. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 483.475) L. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 484.22) M. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 485.68) N. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 485.625) O. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 485.727) P. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 485.920) Q. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 486.360) R. ICRs Regarding Condition of Participat ion: Emergency Prep aredness (§ 491.12) S. ICRs Regarding Condition of Participat ion: Emergency Prep aredness (§ 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 Institut ions (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))13

G. Emergency Preparedness for Psychiatri c Residential Treatment Facilities (PRTFs) Training and Testing (§ 441.184(d)) H. Emergency Preparedness for Program fo r the All-Inclusive Care for the Elderly (PACE) Organizations--Trai ning and Testing (§ 460.84(d)) I. Condition of Participation: Emergency Preparedness for Hospitals J. Condition of Participation: Emerge ncy Preparedness for Transplant Centers K. Emergency Preparedness for L ong Term Care (LTC) Facilities L. Condition of Participation: Emergency Preparedness for Intermediate Care Facilities

for Individuals with Intelle ctual Disabilities (ICFs/IID) M. Condition of Participation: Emergenc y Preparedness for Home Health Agencies (HHAs) N. Conditions of Participation: Comprehe nsive 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 Pr oviders of Outpatient Physical Therapy and Speech-Language Pathology ("Organizations") --Testing (§ 485.727(d)(2)(i) through (iii)) Q. Condition of Participation: Emergenc y Preparedness for Community Mental Health Centers (CMHCs)--Training and Testing (§ 485.920(d)) R. Conditions of Participation: Emergency Preparedness for Organ Procurement Organizations (OPOs)--Tr aining and Testing (§ 486.360( d)(2)(i) through (iii))14

S. Emergency Preparedness: Conditions fo r Certification for Rural Health Clinics (RHCs) and Conditions for Coverage for Fe derally Qualified Health Clinics (FQHCs) T. Condition of Participation: Emergency Preparedness for End-Stage Renal Disease Facilities (Dialysis Facilities)--Tes ting (§ 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 Stat es has been challenged by several natural and

man-made disasters. As a result of the Se ptember 11, 2001 terrorist a ttacks, the subsequent anthrax attacks, the catastrophi c 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 fo r public health emergencies has been put on the national agenda. For the purpose of this prop osed regulation, "emergency" or "disaster" can be defined as an event affecting the overall ta rget population or the community at large that precipitates the declarati on of a state of emergency at a local, state, regional, or national level by an authorized public official su ch 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 Informa tion notice entitled, "Health Center Emergency15

Management Program Expectations," (Doc ument No. 2007-15, dated August 22, 2007, found at http://www.hsdl.org/?view&did=47 8559). Disasters can disrupt th e 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 review ed the guidance, developed by the Food and Drug Administration (FDA), the Centers for Diseas e Control and Prevention (CDC), the Health

Resources and Services Administ ration (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 prep aredness requirements. To guide us in the development of this rule, we also reviewed seve ral other sources to find the most current best practices in the health care industry. These s ources included other federal agencies; The Joint Commission (TJC) standards for emergency preparedness; the American Osteopathic Association (AOA) standards for disaster preparedness (curren tly written for Critical Access Hospitals (CAHs) only); the National Fire Prot ection Association (NFPA ) standards in NFPA 101 Life Safety Code and NFPA 1600: "Sta ndard on Disaster/Emergency Management and Business Continuity Programs," 2007 Edition; state- level requirements for some states, including those for California and Mary land; and policy guidance from the American College of Healthcare Executives (ACHE), entitled the "H ealthcare Executives’ Role in Emergency Preparedness," which reinforces our position regarding the necessity of this proposed rule. Many of the resources we reviewed in the developm ent of this proposed rule are listed in the APPENDIX—“Emergency Preparedness Resource Documents and Sites.” We encourage16

providers and suppliers to use these resources to develop and maintain their emergency preparedness plans. We also reviewed existing Medicare em ergency preparedness requirements for both providers and suppliers. We concluded that current emergency preparedness regulatory requirements are not comprehensiv e enough to address the complexiti es of actual emergencies. Specifically, the requirements do not address the n eed 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 federa l, state, and local le vels and with various stakeholders, we believe that, currently, in the event of a disaster, hea lth 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. Underl ying this problem is the pressing need for a more consiste nt 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, pa rticipants, and their communities. As we have learned from past events and disasters, the curr ent 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 disa ster. Thus, we are proposing these emergency preparedness requirements to establish a comp rehensive, consistent, flexible, and dynamic regulatory approach to emerge ncy preparedness and response th at incorporates the lessons learned from the past, combined wi th the proven best practices of th e present. We recognize that17

central to this approach is to develop and gui de 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 coordi nate their preparedness e fforts within their own

communities and states as well as across state lines , as necessary to achieve their goals. We are soliciting comments on whether ce rtain 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 Medicai d providers and suppliers. This proposed rule addresses the three key essentials needed to ensure that health ca re is available during emergencies: safeguarding human resources, ensuring business contin uity, and protecting physical resources. Current regulations for Me dicare and Medicaid prov iders and suppliers do not adequately address these key elements.

Based on our research and consultation with st akeholders, we have identified four core

elements that are central to an effectiv e and comprehensive framework of emergency preparedness requirements for the various Medi care and Medicaid partic ipating providers and suppliers. The four elements of the emer gency preparedness program are as follows:

● Risk assessment and planning: This proposed rule would propose that prior to establishing an emergency plan, a risk assessm ent would be performed based on utilizing an “all-hazards” approach. An all-hazards appro ach is an integrated approach to emergency preparedness planning that focuses on capacities and capabilities that are cri tical to preparedness for a full spectrum of emergencies or disasters. This approach is specific to the location of the18

provider and supplier considering th e particular types of hazards which may most likely occur in

their area.

● Policies and procedures: We are proposing that facilities be re quired 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 communica tion plan that complies with both federal and

state law. Patient care must be well-coordinated within the facil ity, across health care providers, and with state and local public health departments and emerge ncy 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 pr ogram. A well-organi zed, effective training program must include providing initial training in emergenc y preparedness policies and procedures. We propose that the facility ensure that sta ff can demonstrate knowledge of emergency procedures and provide this training at least annua lly. We would require that

facilities conduct dr ills 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, th ere have been numerous efforts across federal agencies to establish a foundati on for development and expansion of emergency preparedness systems. The following is a brief overview of some emergency preparedness19

activities at the federal level. Additional information is included in the appendix to this proposed

rule.

a. Presidential Directives Three Presidential Directives HSPD-5, H SPD-21 and PPD-8, require agencies to coordinate their emergency preparedness activities with each other and across federal, state, local, tribal, and territorial governments. Alt hough 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 s uppliers in regard to their role s in a more unified emergency preparedness system. The Homeland Security Presidential Directive (HSPD-5), "Management of Domestic Incidents," was issued on Febr uary 28, 2003. This directive authorizes the Department of Homeland Security to develop an d administer the Nationa l Incident Management System (NIMS). The NIMS provides a consistent national template that enables federal, state, local, and tribal governments, as well as privat e-sector and nongovernment al organizations, to work together effectively and efficiently to pr epare for, prevent, respond to, and recover from domestic incidents, regardless of cause, size, or complexity, including acts of catastrophic terrorism. The Presidential Policy Directive (P PD-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, includi ng 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 comm unity 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 pu blished on October 18, 2007, entitled, "Homeland Securi ty Presidential20

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 (Strat egy), which aims to transform our national approach to protecting the heal th 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 stockpili ng and distribution, mass casualty care, and community resilience. The dire ctive 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 Pa ndemic and All-Hazards Preparedness Act is “to improve the Nation’s public health and medi cal preparedness and response capabilities for emergencies, whether deliberate, accidental, or natural.” The Office of the Assistant Secretary for Preparedness and Response (ASPR) was crea ted under the PAHPA Act in the wake of

Katrina to lead the nation in preventing, preparing for, and re sponding to the adverse health effects of public health emergenc ies and disasters. The Secretary of HHS delegates to ASPR the leadership role for all health and medical serv ices support functions in a health emergency or public health event. ASPR also serves as th e senior advisor to th e HHS Secretary on public health and medical preparedne ss and provides, at a minimum, support for; building federal emergency medical operational response and rec overy capabilities; countermeasures research, advance development, and procurement; and grants to strengthen the capabilities of healthcare preparedness at the state, regional, local a nd healthcare coalition levels for public health emergencies and medical disasters. The o ffice provides federal s upport, including medical21

professionals through ASPR’s National Disaster Medical System (NDMS), to augment state and local capabilities during an emergency or disast er. The purpose of the NDMS is to establish a single, integrated, and national medical response capab ility to assist state and local authorities in dealing with the medical impacts of major p eacetime 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 conf licts. The NDMS, as part of the HHS, led by ASPR, supports federal agencies in the manage ment and coordination of the federal medical response to major emergencies and federally de clared disasters includi ng natural disasters, technological disasters, major tr ansportation accidents, and acts of terrorism, including weapons

of mass destruction even ts. Additional information can be found at: http://www.phe.gov/preparedness/res ponders/ndms/Pages/default.aspx

. ASPR also administers the Hospital Prep aredness Program (HPP), which provides leadership and funding through grants and cooperati ve 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 co mmunities in numerous ways, including building healthcare coalitions, planning for all hazards, in creasing 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 vo lunteer organizations. This aspect of the “disaster response” is speci fically coordinated by st ate and local authorities. When an incident overwhelms or is anticipated to overwhelm state resources, the Governor of a state or chief22

executive of a tribe may request fe deral assistance. In such cases, the affected local jurisdiction, tribe, state, and the federal government will coll aborate to provide that necessary assistance. When it is clear that state capabilities will be ex ceeded, the Governor or the tribal executive can request federal assistance, in cluding assistance under the Robert Stafford Disaster Relief and Emergency Assistance Act (Stafford Act) . The Stafford Act authoriz es the President to provide

financial and other assistance to state and local government s, certain private nonprofit organizations, and individuals to support res ponse, recovery, and mitigation efforts following Presidential emergency or ma jor disaster declarations. The National Response Framework (NRF), a gui de to how the nation should conduct all hazards responses, includes 15 Emergency Suppor t Functions (ESFs), which are groupings of governmental and certain private sector capabili ties into an organizational structure. The purpose of the ESFs is to provide support, res ources, 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 agen cy responsible for ESF 8- Public Health and

Medical Services. The Secretary of HHS leads all federal publ ic 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 Assistan t Secretary for Preparedness a nd Response (ASPR). ESF 8 – Public Health and Medical Services provides the mechanism for coordinated federal assistance to supplement state, tribal, and lo cal jurisdictional resources in response to a public health and23

medical disaster, potential or actual incidents re quiring a coordinated fede ral response, or during a developing potential hea lth and medical emergency.

c. Centers for Disease Control and Prevention

The Centers for Disease Control and Prev ention (CDC) Office of Public Health Preparedness and Response (OPHPR) leads the ag ency's preparedness a nd response activities by providing strategic direction, support, and coordina tion for activities across CDC as well as with local, state, tribal, national, te rritorial, and interna tional public health partners. CDC provides funding and technical assistance to states to build and strength en public health capabilities. Ensuring that states can adequately respond to th reats will result in grea ter health security; a critical component of overall U.S. national secu rity. 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 depart ments. Since 2002, the PHEP c ooperative agreement has provided nearly $9 billion to public health department s across the nation to upgrade their ability to effectively respond to a range of public health th reats, including infec tious diseases, natural disasters, and biological, chemical, nuclear, and radiological events. Preparedness activities funded by the PHEP cooperative ag reement are targeted specifi cally 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 create d to assist states and local communities in responding to public health emergencies, includ ing 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 effects24

of biological pathogens and chemical and nerve agents. (http://www.cdc.gov/phpr/sto ckpile/stockpile.htm). The Cities Readiness Initiative (CRI), led by CD C, is a federally funded pilot program to help cities increase thei r capacity to deliver medicines and medical supplies within 48 hours after recognition of a large-scal e 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 progr am 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/techni cal_reports/2009/RAND_TR640.pdf

. Given the heightened concern regarding the impact of various influenza outbreaks in recent years, the federal government has create d a website with "one-step access to U.S. Government H1N1, Avian, and Pandemic Flu Information" at www.flu.gov . The website provides links to influenza guidanc e and information from federal ag encies, 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 website includes information for hospitals, long term care facilities, outpati ent facilities, home health agenci es, other health care providers, and clinicians. For example, the "Hospital Pa ndemic Influenza Planning Checklist" provides guidance on structure for planni ng and decision making; development of a written pandemic influenza plan; and elements of an influenza pa ndemic 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 pl anning and response groups to infection control.25

2. State and Local Preparedness

A review of studies and arti cles regarding readiness of state and local jurisdictions reveals that there is inconsistency in the le vel of emergency preparedness amongst states and need for improvement in certain areas. In a re port by the Trust for America’s Health (TFAH) (December 2012, http://www.healthyamericans.org/ report/101/) en titled, "Ready or Not? Protecting the Public’s Health from Diseases, Di sasters, and Bioterrorism" the authors assessed state-by-state public health preparedness nearly 10 years after the September 11th and anthrax tragedies. Using 10 key indicato rs to rate levels of public health preparedness, some key findings included: (1) 29 states cut public heal th 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 loca l preparedness have decr eased by 38 percent from FY 2005 through 2012 and (2) 35 states and Washington D.C. 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., Luri e, N., and Diamond, A.) evaluated the ability of local public health agencies (LPHAs) to adeq uately meet "a preparedness standard" set by the

CDC. The standard was for the LPHAs "to re ceive and respond to ur gent case reports of communicable diseases 24 hours a day, 7 days a wee k." Using 18 metropolitan area LPHAs that were roughly evenly distributed by agency size, st ructure, and region of the country, the goal of

the test was to contact an "act ion officer" (that is, physician, nurs e, epidemiologist, bioterrorism coordinator, or infection contro l practitioner) responsible for responding to urgent case reports.26

During a 4-month period of time, each LPHA was contacted several times and asked questions regarding triage proced ures, what questions would be as ked in the event of an urgent case being filed, next steps taken after receivi ng 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 va riation 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 Vald ez, R. B., entitled, "Local Variations in Public Health Preparedness: Le ssons 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 id entified as urban, rural, and border status to detect and respond to a hypothe tical smallpox outbreak based on the different measures of preparedness. Overall, the resear chers found that there wa s a lack of consensus regarding what "emergency preparedness" encomp assed and a wide variation in what various governmental agencies deemed to be adequa te emergency prepare dness "readiness" in California. They noted that gaps in the infrastructure were common. Throughout the jurisdictions invest igated, there were si milarities noted in the shortage of nurses, the number of essential workers nearing re tirement 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 incomplete27

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’ atten tion and for these officers to realize that these cases were related. There was great variation in th e public health officers’ ability to rapidly alert the physician and hospital community of an outbrea k. There was a lack of consensus regarding when to report a potential outbreak to the public. There also was wide va riation in knowledge of public health legal authority, sp ecifically, in regard to quaran tine 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 co mmunities; thus, it is essential that hospitals have the capacity to re spond in a timely and appropriate manner in the

event of a natural or man-made disaster. Addi tionally, since Medicare-par ticipating hospitals are required to evaluate and stabilize every patient se en 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 Univ ersity of Pittsburgh Medical Center (UPMC) (the Center) to conduc t an assessment of U.S. hospital preparedness and to develop recommendations for evaluati ng and improving future hospital preparedness efforts. The Center’s assessment, entitled "Hosp itals Rising to the Challenge: The First Five28

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 leve ls. This evaluation report was ba sed on extensive analyses of the published literature, government reports, a nd HPP program assessments, as well as on

detailed conversations with 133 health official s 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 capabi lity) such as occurred with Hurricane Katrina. The authors further stated that addressing medi cal surge and medical system resilience requires implementing systems that can effectively mana ge medical and health responses, as well as developing and maintaining preparedness progr ams. There were numerous findings and conclusions in the 2007 report. The researcher s found that since the start of the HPP in 2002, individual hospitals’ disaster preparedness has improved signif icantly. The report found that hospital senior leadership is actively supporting and participati ng in preparedness activities, and disaster coordinators within hospitals have given sustained attenti on to preparedness and response planning efforts. Hospital emergency operations plans (EOPs) have become more comprehensive and, in many locations, are coor dinated with community emergency plans and local hazards. Disaster training has become mo re rigorous and standardized; hospitals have stockpiled emergency supplies a nd medicines; situational awar eness and communications are improving; and exercises are more frequent and of higher quality. The researchers also found improved collaboration and networking among and betw een hospitals, public health departments,29

and emergency management and response agencies. These coalitions are believed to represent the beginning of a coordinate d community-wide approach to medical disaster response. However, ASPR Healthcare Preparedness Capab ilities: National Guidance for Healthcare System Preparedness (2012) and CDC Public Health Preparedness Capabilities: National Standards for State and Local Planning (March 2 011) 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 coordinate d, interoperable disaster response. (IOM Medical Surge Capacity. 2009 Forum on Medical and Pub lic 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 st udies point to a need for improved requirements to ensure that providers and s uppliers are adequately prepared to meet the needs of patients, residents, clients, and participants duri ng 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 prepare dness, the Office of the Inspector General (OIG) conducted a study during 2004 thr ough 2005 entitled, "Nursi ng Home Emergency Preparedness and Responses During R ecent 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 th e limited federal regulations for emergency30

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 experi enced problems even though they we re in compliance with federal interpretive guidelines. Further, they experien ced problems whether they evacuated residents or sheltered them in place. The OIG listed the pr oblems encountered by Gulf state nursing homes including, transportation contract s that were not honored; lengthy travel times for residents;

insufficient food and water for residents and staf f; complicated resident medication needs; host

facilities that were unavailable or that were inad equately prepared, provisioned, or staffed for the transfer of residents; and difficu lty re-entering their ow n 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 an ticipate the specific pr oblems encountered; and failure to adjust decisions and actions to specific situations. The OIG also found that some facility admini strators 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 ci rcumstances. The report goes on to note that many of the nursing home emergency preparedness pl ans 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 direc tly involved in the evacuation of their nursing home residents, other nursi ng homes received assistance w ith evacuation from resident and staff family members, parent corporations, and "sister faci lities," according to the OIG31

report. A few nursing homes reported that problems with state and local government coordination during the hurricanes contribu ted to the problems they encountered. Based on this study, the OIG had two recommen dations for CMS: (1) strengthen federal certification standards for nursing home emergenc y plans by including requirements for specific elements of emergency planning; and (2) encourage communication and collaboration between state and local emergency entities and nur sing homes. As a result of the OIG’s recommendations, the Secretary initiated an emer gency 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 addressi ng the OIG recommendations. In April 2012, the OIG issued a subsequent report entitled, “Gaps Continue to Exist in Nursin g Home Emergency Preparedness and response During Disaters : 2007-2010,” (OEI-06-09-00270 http://oig.hhs.gov/oe i/reports/oei06-09-00270.pdf ). This report notes that many of th e 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 en titled, "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) responsib ility for the decision to evacuate ho spitals and nursing homes; (2) the issues administrators consider when deciding to evacuate hospitals a nd nursing homes; and (3) the federal response capabilities that suppor t evacuation of hospitals and nursing homes.32

The GAO found that "hospital and nursing home administrators are often responsible for deciding whether to evacuate patients from their f acilities due to disaster s, including hurricanes

or other natural disasters. State and local governments can or der evacuations of the population or segments of the population during emergencies, but health care facilitie s may be exempt from these orders." The GAO found that hospitals a nd nursing home administrators evacuate only as

a last resort and that these fac ilities’ 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 d eciding 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 al so 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 even t of an evacuation, nursing homes also need to consider the necessity of locat ing facilities that can accommod ate their residents for a long period of time. A second report from the GAO about the hu rricanes’ 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 disa sters. In addition, the GAO noted that the

evacuation issues that faciliti es 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 assist ance overwhelmed the supply of vehicles in the community.33

A third report, an after-event analysis enti tled, "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/de tails.php?rptno=GAO-06-1003 ) revealed that, as of April 2006: (1) emergency department s were experiencing overcrowding; but that (2) the number of staffed inpatient beds per 1,000 popul ation was greater than that of the national average and expected to increase further. Howe ver, 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 be ds 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 majo r 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 pers ons who seek mental health services and require inpatient psychiatric car e can be expected fo llowing 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 Hu rricane 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 un dertaking 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 technical34

assistance for recovery, state and local jurisdictions should work cl osely with federal agencies to

secure and make use of those resources. In a report from the GAO, entitled, "Influ enza 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 poten tial 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 responsib le federal agencies (including HHS) in implementing the action items set forth in th e "National Strategy for Pandemic Influenza: Implementation Plan" (the Plan) ( http://georgewbushwhitehouse.archives.gov/homeland/pande mic-influenza-implementation.html ). Specifically, the researchers were interested in determining how the Homeland Security Council (HSC) and the responsible federal agencies were monitori ng 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 se lected action items reported as co mplete, 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 consid ered 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 ac tion items; (2) some selected action items were35

designated as complete despite requiring actions ou tside the authority of th e responsible entities; and (3) additional work was conducted on some se lected 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 s ubsequent updates of the Plan, the HSC should

instruct the White House Nationa l Security Staff (NSS) to work with responsible federal agencies to: (1) develop a monitoring and reporti ng process for action items that are intended for nonfederal entities, such as st ate and local governments; (2) id entify the types of information

needed to decide whether to carry out the respons e-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 requi rements 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 hea lth and safety of patients, although the exact wording of such authority may differ slightly between different provider and supp lier types. These requirements are called the Conditions of Participation (CoP s) for providers and the Conditi ons for Coverage (CfCs) for suppliers. The CoPs and CfCs are intended to pr otect 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 Me dicare providers and suppliers must meet to participate. The following are the statutory and regulatory c itations for the provide rs and suppliers for which we intend to propose emergency preparedness regulations:36

● Religious Nonmedical Health Care Inst itutions (RNHCIs) – sect ion 1821 of the Act and 42 CFR 403.700 through 403.756.

● Ambulatory Surgical Centers (ASCs) – s ection 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 Servi ces for Individuals Under Age 21 in Psychiatric Facilities or Programs (PRTFs) – sections1905(a) and 1905(h) of the Act and 42 CFR 441.150 through 441.182 and 42 CFR 483.350 through 483.376.

● Programs of All-Inclusive Care for th e 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 –Skille d 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 Rehabilitati on 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 4237

CFR 485.601 through 485.647.

● Clinics, Rehabilitation Agencies, and P ublic 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 (CMH Cs) – 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 Ac t and section 371 of the PHS Act and 42 CFR 486.301 through 486.348.

● Rural Health Clinics (R HCs) - section 1861(aa) of the Act and 42 CFR 491.1 through 491.11; Federally Qualified Health Centers (FQHC s) - section 1861(aa) of the Act and 42 CFR 491.1 through 491.11, except 491.3.

● End-Stage Renal Disease (ESRD) Faciliti es – sections 1881(b), 1881(c), 1881(f)(7) of the Act and 42 CFR 494.1 through 494.180. We considered proposing these regulati ons for each provider and supplier type individually, as we updated their CoPs or CfCs over time. However, fo r the reasons we have already discussed, we believe the most prudent course of action is to publish emergency preparedness requirements for Medicare and Me dicaid providers and suppliers in a single proposed rule. Thus, we are proposing regulat ory language for 17 Medicare and Medicaid providers and suppliers to addre ss the four main aspects of em ergency preparedness:--(1) risk assessment and planning; (2) policies and pro cedures; (3) communicatio n; and (4) training.38

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 car e providers and suppliers to plan and execute appropriate emergency response procedures for di sasters. We developed this proposed rule taking into consideration the exte nt of regulatory oversight that is currently in existence. We are proposing requirements for faciliti es 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 th at address these functions too specifically may become outdated over time as technology and the na ture of threats change. However, as our analysis of existing regulations , and the OIG and GAO reports disc ussed 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 acro ss provider and supplier types as diverse as hospitals, organ procurement organizations, a nd home health agencies, while tailoring requirements for individual provid er and supplier types to their sp ecific needs and circumstances, as well as the needs of their patients, re sidents, 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 requ irements for the various Medicare- and Medicaid-participating providers an d suppliers. The four elements are--(1) risk assessment and planning; (2) policies an d procedures; (3) communication; and (4) training and testing. We have also proposed an additional requirement for OP Os entitled "Agreements with other OPOs and hospitals."39

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 leve l, for example, a system for preserving medical documentation. Our regulator y requirements for each provider and supplier type are based on the comprehensive emergenc y preparedness requirements that we are proposing for hospitals. Since we are aware that the applicati on 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 provi ders and suppliers but have specific proposed requirements tailored to each providers' and supp liers' 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 require d to establish an emergency preparedness plan that addressed the four co re elements noted previously. The proposed requirements vary based on the type of provider. We discuss the ho spital requirements in de tail at the beginning of this section. The subsequent discussion of the proposed requirements for all remaining providers and suppliers focuses on how the requirements di ffer from those proposed for hospitals and why. For example, because they are inpatient f acilities, religious nonmedical health care institutions (RNHCIs), psychiat ric residential treatment fac ilities (PRTFs), skilled nursing facilities and nursing home s (referred to in this document as long term care (LTC) facilities),

intermediate care facilities individuals with intellectual disabilities (IC Fs/IID), and critical access hospitals (CAHs) may have greater responsi bility than outpatient facilities during an emergency for ensuring the health and safety of persons for whom they provide care, their40

employees, and volunteers. Thus, proposed requ irements 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 cl inics (RHCs), federally qualified health centers (FQHCs), and end stage renal disease (ESRD) fa cilities, may not open th eir 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 outpa tient facilities may find it necessary to shelter their patients until they can be evacuated or may be called upo n to provide some level of care for community residents in the event of an emergency. For exam ple, 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 shelte r from the elements or may provide water, food, and basic self-care items, if available. Finally, given that some hospice faciliti es provide both inpatient and home based services, and that transplant ce nters and OPOs are unique in thei r provision of health care, our proposed requirements are tailored even more speci fically to address the circumstances of these

entities. We believe lessons learned followi ng the 2005 hurricanes and subsequent disasters, such as the flooding in the Midwest in 2008, and the tornadoes and flooding in 2011and 2012, have provided us with an opportunity to work colla boratively with the hea lth care community to ensure best practices in emergency prepar edness 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 w ould be different, based on the category of the41

provider or supplier. For example, we propose th at nearly all providers and suppliers would be required to have policies and procedures to provi de subsistence needs to staff and patients during an emergency. However, a small RHC's implem entation of this requirement would be quite different from a large metropolitan hospital's implementation. Specifically, with respect the proposed requirement that hospitals, CAHs, inpatie nt hospice facilities, PR TFs, LTC facilities, ICFs/IID, and RNHCIs would be required to maintain variou s subsistence needs, we are requesting public comment regarding whether this should be a requirement and in what quantities and for what time period these subsiste nce needs would be maintained. Nevertheless, we expect that each facility would determine how to implement a requirement considering similar variables such as whether the provide r might have the option of notifying staff and patients not to come to the facility due to an em ergency; the number of st aff and patients likely to be in the facility at the time of an emergency; whether the provid er would have the capability of providing shelter, provisions, a nd health care to members of the community; and the amount of space within the facility available for stori ng provisions. Although various providers and suppliers utilize different nomenclature to descri be 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 indi viduals 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 provide rs and suppliers deemed by accrediting organizations to meet the Medicare conditions of particip ation are from CMS's second quarter fiscal year 2010 Accrediting Orga nization System for Storing User Recorded42

Experiences (ASSURE) database. Currently, there are accrediting organizations with Medicare deeming authority for hospitals, critical access hospitals, HHAs, hos pices, and ASCs. Data for CAHs that report having psychiat ric and rehabilitation Distinct Part Units (DPUs) are from the Medicare Qualit y Improvement and Evaluation System (QIES)/Certification and the Survey Provider En hanced Reporting (CASPER) system as of

March 2013. Data for CAHs that do not have DP Us are from the Online Survey, Certification, and Reporting (OSCAR) data system as of Marc h 2013. Data for the number of transplant

centers are from the CMS website as of March 2013. Data for the total number of accredited and non-accredited hospitals, HHAs, AS Cs, 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 PA CE organizations may have more than one "center," we are using

the number of PACE contracts as a reflection of the number of PA CE centers under contract with

the CMS. Note that the CMS OSCAR data system is upda ted 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-accre dited facilities shown may not equal the total number of

facilities. Discussion of the proposed regulatory provisi ons 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 Regulatio ns (CFR). However, our discussion of the hospital requirements includes a general discus sion of the differences between our proposed requirements, based on whether providers and supp liers provide outpatient services or inpatient43

services or both. Thus, we encourage all pr oviders to read the di scussion of the proposed hospital emergency preparedness requirements in section II.A. of this proposed rule. This section also provides detailed disc ussion of each proposed hospital requirement, offers resources that providers and suppliers can use to meet th ese proposed requirements, offers a means to establish and maintain emergency prep aredness for their facilities, and provides links to guidance materials and toolki ts that can be used to help meet these requirements. A. Emergency Preparedness Regul ations for Hospitals (§ 482.15) Section 1861(e) of the Act defines the term "hospital" and subsecti ons (1) through (8) list requirements that a hospital must meet to be eligible for Medicare pa rticipation. Section 1861(e)(9) of the Act specifies th at a hospital must also meet such other requirements as the Secretary finds necessary in the in terest of the health and safety of individuals who are furnished

services in the institu tion. Under the authority of 1861(e) of the Act, th e Secretary has established in regulations at 42 CFR part 482 th e requirements that a hos pital must meet to participate in the Medicare program. Section 1905(a) of the Act provides that Me dicaid payments may be applied to hospital services. Regulations at § 440.10(a) (3)(iii) require hospitals to m eet 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 ho spital 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 hosp ital CoPs, and must comply with CAH-specific CoPs. Proposed requirements for CAHs are laid out in §485.625.44

Services provided by hospitals encompass i npatient and outpatient care for persons with

various acute or chronic medi cal 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 hospita ls 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 prepare dness planning with other provid ers 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 prog ram encompasses an approach to emergency preparedness that allows for continuous build ing of a comprehensive system of health care response to a natural or man-made emergency. We are also proposing th at a hospital, and all other providers and supplie rs, utilize an "all-hazards" approach in the preparation and delivery of emergency preparedness services in order to m eet the health and safety needs of its patient population. The definition of "all hazards" is discussed later in this sec tion under "Emergency

Plan." We would expect that during an emergency, in jured and ill individuals would seek health care services at a hospital or CAH, rather than from another provider or s upplier. 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,45

affected individuals would not expect to recei ve 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 broade r 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 emergenc y 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 addre sses an "all-hazards approach" to medical and non-medical emergenc y events. In keeping with the emergency management industry and with strong recomm endation from the Department's Assistant Secretary for Preparedness and Response (ASPR), we are proposing that a ll providers utilize an all-hazards approach to emergency response. We do not specify the qua ntity 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 emergenc y preparedness program, the plan for response, or both. A facility-based risk as sessment is contained within the actual facility and carried out by the facility. A community based risk assessmen t is carried out outside the organization within their defined community. 1. Emergency Plan a. Emergency Planning Resources To stimulate and foster improved emergenc y preparedness continuity of operations, the federal interagency community has developed fifteen all-hazards planning scenarios, entitled the46

"National Planning Scenarios" for use in federal, state, and local homeland security preparedness activities. These scenarios serve as planning t ools 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 anth rax; biological disease outbreak – pandemic influenza; biological attack – plague; chemical attack – blister agent; ch emical attack – toxic industrial chemicals; chemical attack – nerve ag ent; chemical attack – chlorine tank explosion; natural disaster – major earthquake; and natural di saster – major hurricane; radiological attack – radiological dispersal devices; e xplosive attack - bombing usi ng improvised explosive device; biological attack – food contamination; biologic al attack – foreign animal disease (foot and mouth disease); and cyber attack. Additional s cenarios include volcano preparedness and severe winter weather (snow/ice). Additional inform ation 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-directive8#MajorElements

. These planning tools along with other emer gency management and business continuity

information can be found on HRSA's website at: http://www.hrsa.gov/emergency/ and also in HRSA's, Policy Information Notice entitled, "Hea lth Center Emergency Management Program Expectations," (No. 2007-15), dated August 22, 2007, at: http://bphc.hrsa.gov/poli ciesregulations/policie s/pin200715expectations.html ). While these materials were developed for hea lth centers, the content is releva nt to all health providers. According to the notice emergency management pla nning is to ensure pred ictable staff behavior during a crisis, provide specific gui delines and procedures to follo w and define specific roles. Also, emergency planning should address the f our phases of emergency management that47

include: mitigation activities to lessen the sever ity and impact a potential disaster or emergency might have on a health center's operation; prepar edness activities to build capacity and identify resources that may be used should a disaster or emergency occur; re sponse to the actual emergency and controls the negative eff ects of emergency situations; and recovery that begin almost concurrently with response activities and ar e 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 heal th care. According to HRSA, th e 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 in to what centers already are doi ng related to emergency and risk management. While this guidance is targeted to ward centers, we believe hospitals and all other providers and suppliers can use this guidan ce 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/healthca re/documents/shuttools.pdf or at: http://archive.ahrq.gov/research/shuttered/toolki tchecklist/), which w ill allow hospitals and emergency planners to estimate the resources need ed 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 Nationa l Planning Scenarios, previously discussed, the AHRQ Hospital Surge Model allows users to select a disaster scenario and estimate the number of patients needing me dical attention by arrival cond ition and day; the number of casualties in the hospital by unit a nd day; and the cumulative number of both dead or discharged48

casualties by day. The tool also calculates the level of hospital resource s, including personnel, equipment and supplies, needed to treat patients. The model estimates resources for biological, chemical, nuclear or radiological attacks. (F or the development of emergency preparedness plans, providers and suppliers may also find th e National Fire Protecti on Association's (NFPA) NFPA 1600: "Standard on Disaster/Emergency Ma nagement and Business Continuity Programs, 2013 Edition," particularly helpful. The NFPA document can be found at: http://www.nfpa.org/aboutthecode s/AboutTheCodes.asp?DocNum=1600 . The standard sets forth the basic criteria for a comprehensive progra m that addresses disaster recovery, emergency management, and business continuity. Under mo st definitions, the NFPA 1600 is an industry standard for disaster management. Also of concern when developing an emergenc y plan is the issue of the allocation of scarce resources during a potential ly devastating event. Disasters can create situations where

such resources must be distributed in a manner th at is different from usual circumstances, but still appropriate to the situat ion. As discussed in "Providi ng Mass Medical Care with Scarce Resources: A Community Planning Guide , Publication No. 07-0001, Rockville, MD: Agency for Healthcare Research and Quality," (found a t: 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); ke y constructs, principles, and structures to be incorporated into the planning fo r an MCE; approaches and strategies that could be used to provide the most appropriate st andards 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 approached49

certain issues as part of their MCE-related pl anning efforts. Building on the work from 2008, the Institute of Medicine (IOM) released in 2012 a gui dance report entitled "The Crisis Standards of Care (CSC): A Systems Framework for Cata strophic Disaster Res ponse" available at: http://www.iom.edu/Reports/2012/Crisis-Standards-of-Care-A-Systems-Framework-forCatastrophic-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 subs tantial shift in normal health care activities and reallocation of staff, facilitie s, 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 ad dress 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 Join t Commission (TJC), formerly known as the

Joint Commission on the Accreditation of Hea lthcare Organizations, 2006). The document by TJC is a comprehensive resource that offers step-by-step guidance fo r 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_Toge ther__An_Emergency_Planning_Guide_for_Am50

ericas_Communities/ . This document may be particularly useful for small or rural facilities and agencies. Rural communities face challenges in the delive ry of health care that are often very different from those faced by urban and s uburban communities. While rural communities depend on public health departments, hospita ls, and emergency medical services (EMS) providers just as urban and suburban commun ities do, rural communities tend to have fewer health care resources overall. A report entitled, "Rural Communities and Emergency Preparedness," (published by the Health Resource s and Services Administration's (HRSA) Office of Rural Health Policy, April 2002, found at: ftp://ftp.hrsa.gov/ruralhea lth/RuralPreparedness.pdf ) addresses the issues faced by rural communities with respect to emergency preparedness. The authors report that there are many factors th at 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 resource s (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 develope d a plan to deal with a bioterrorism event.

The researchers also found that th e majority of rural pub lic 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 larger51

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 coor dinated emergency preparedness system, as outlined in the PPD-8, NIMS, NRF, HSPD-21, and P AHPA/PAHPRA, we are proposing at § 482.15 that all hospitals establish and maintain an emergency preparedness plan that complies with both federal and state require ments. Additionally, we propose that a hospital would develop and maintain a comprehensive emergency preparedness program, utilizing an "all-hazards" approach. The emergency prepar edness 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, th e hospital and all other providers would first perform a risk assessment based on utilizing an "a ll-hazards" approach. An all-hazards approach is an integrated approach to emergency pr eparedness planning. In the abstract of a November 2007 paper entitled, "Universal Design: The All-Hazards Approach to Vulnerable Populations Planning" by Charle s K.T. Ishikawa, MSPH, Garrett W. Simonsen, MSPS, Barbara Ceconi, MSW, and Kurt Kuss, MSW, the research ers described an all-hazards planning approach as "a more efficient and effective way to pr epare for emergencies. Rather than managing planning initiatives for a multitude of threat scenarios, all-hazards planning focuses on developing capacities and capabilitie s that are critical to prepar edness for a full spectrum of emergencies or disasters." Thus, all-hazards planning does not specifically address every52

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 hospit als perform all-hazards risk a ssessment consistent with the concepts outlined in the National Preparedne ss Guidelines, the "Guidelines" published by the U.S. Department of Homeland Security that we desc ribed in section I.A.3 of this proposed rule. Additional guidance and resources for assistan ce with designing and performing a hazard vulnerability assessment include: the Comprehe nsive Preparedness Guide 201: Threat and

Hazard Identification and Risk Assessment Guide (available at: http://www.fema.gov/library/viewRec ord.do?fromSearch=fromsearch&id=5823 ), the Use of

Threat and Hazard Identification and Ri sk Assessment for Preparedness Grants (available at: http://www.fema.gov/library/viewRec ord.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/viewRec ord.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 wh en a natural or manmade disaster, terrorist attack, or other catastrophic ev ent threatens the soundness of a facility. The guides examine how hospital personnel have coped under emergency situ ations in the past to better understand what53

factors should be considered when making evacuation, shelter-in-place, and reoccupation

decisions. The guides entitled, "Hospital Evacuation D ecision Guide" and "Hospital Assessment and Recovery Guide" are intended to supplemen t hospital emergency plans, augment guidance on determining how long a decision to evacuate ma y be safely deferred, and provide guidance on how to organize an initial assessmen t of a hospital to determine when it is safe to return after an

evacuation. The evacuation guide distinguishes betw een "pre-event evacuations" which are undertaken in advance of an impending disaster, su ch as a storm, when the hospital structure and surrounding environment are not ye t significantly compromised a nd "post-event evacuations,"

which are carried out after a disaster has dama ged 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 patie nt evacuation and factors to c onsider when a threat looms. The assessment and recovery guide helps hospi tals determine when to get back into a hospital after an evacuation. Co mprised primarily of a 45-page checklist, the guide covers 11 separate areas of hospital infras tructure that should be evaluate d before determining that it is safe to reoccupy a facility, such as securi ty and fire safety, information technology and communication and biomedical engineering. The "Hospital Evacuation Deci sion Guide" can be found at: http://archive.ahrq.gov/prep/hospevacguide/ ) (AHRQ Publication No.10-0009), and the

" Hospital Assessment and Recovery Gu ide" can be found at (found at: http://archive.ahrq.gov/prep/hosprecovery/ ) (AHRQ Publication No. 10-0081).54

Based on the guidance and information in thes e 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 contin ued during an emergency; (2) id entification of all risks or emergencies that the hospital may reasonably ex pect to confront; (3) identification of all contingencies for which the hospital should plan ; (4) consideration of the hospital's location, including all locations where th e hospital delivers patient care or services or has business operations; (5) assessment of the extent to wh ich 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 su ppliers, or other entities might be needed to

ensure that essential services coul d 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 assessm ent. For example, a hospital in a large metropolitan city may plan to ut ilize the support of othe r 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 fo r circumstances in whic h 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 hospi tal 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 coul d use the services of a hospital located in the adjoining state if the hospital was closer or provide d more services than the neares t hospital in the state in which55

the individual resides. Therefore, we would en courage hospitals in adjo ining 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 contin uity of care during a disaster. c. Patient Population and Available Services At § 482.15(a)(3), we propose that a hospita l's emergency plan address its patient population, including, but not limited to, persons at-risk. As defi ned by the PAHPA, members of at-risk populations may have additional needs in one or more of the following functional areas: maintaining independence, communication, trans portation, supervision, a nd medical care. In addition to those individuals spec ifically recognized as at-risk in the statut e (children, senior citizens, and pregnant women), we are proposing to define "at-risk populations" as individuals who may need additional respons e assistance including those who have disabilities, live in institutionalized settings, are from diverse cultu res, have limited English proficiency or are non-English speaking, lack transportation, have chronic medical disorders, or have pharmacological dependency. Also, as discusse d in "Providing Mass Medical Care with Scarce Resources: A Community Planning Guide," (h ttp://archive.ahrq.gov/rese arch/mce/ ), at-risk populations would include, but are not limited to, the elderly, persons in hospitals and nursing homes, people with physical and mental disabili ties, and infants, and children. Hospitals may find this resource helpful in establishing emergency pl ans that address the need s 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 provi de in an emergency. The hospital should base

these determinations on factors su ch as the number of staffed beds, whether the hospital has an emergency department or trauma center, availa bility of staffing and medical supplies, the56

hospital's location, and its ability to collabora te with other community resources during an

emergency. d. Succession Planning and Cooperative Efforts In regard to emergency preparedness pl anning, we are also proposing at § 482.15(a)(3) that all hospitals include delega tions and succession planning in th eir emergency plan to ensure that the lines of authority dur ing 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 wi th local, tribal, regional, st ate, or federal emergency preparedness officials' efforts to ensure an in tegrated 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 planni ng efforts. We believe that planning with officials in advance of an emer gency to determine how such collaborative and cooperative efforts will be achieve d will foster a smoother, more effective, and more efficient response in the event of a disaster. While we are aware that the responsibili ty for ensuring a coordinated disaster preparedness response lies upon the state and loca l emergency planning authorities, the hospital

would need to document its efforts to contact th ese officials and inform them of the hospital's participation in the coordinated emergency resp onse. Although we propose to require the same efforts for all providers and supplie rs 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 and57

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 wi th other response partners. Many more community healthcare facilities have equipment to protect healthcare wo rkers and decontaminate patients in chemical, biological, radiological, or nuclear emergencies. While the HPP program continues to encour age preparedness at the hospital level,

evidence and real-world events have illustrated that hospitals cannot be successful in response without robust community healthcare coalition pr eparedness--engaging critica l partners. Critical partners include emergency management, public h ealth, mental/behavioral health providers, as well as community and faith-based partners. To gether 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 individua l hospital. HCCs are a cornerst one for the HPP and an integral component for community-wide planning for healthcare resiliency. We are aware that, among some emergency ma nagement leaders, healthcare coalitions

are viewed as a valued and esse ntial component of a coordinate d 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 a nd support their value in the well-coordinated emergency response system and encourage provider s of all types and sizes to engage in such58

collaborations, where possible, to ensure be tter 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 strengt hen the overall health system by leveraging expertise, sharing resources, a nd increasing capacity to respond; thus reducing potential administrative burden for emergency preparedness, wh ile similarly enabling easier emergency response integration and coordination during an emer gency. Healthcare coalition activities provide, at a minimum, an optimal forum for: levera ging leadership and operational expertise (health, public health, emergency management, public works, public safety, etc.) within a community; conducting mutual hazard vulnerabili ty/risk assessments to identify community health gaps and develop plans a nd strategies to address them; developing standardized tools, emergency plans, processes and protocols, training and exercise s to support the community and support ease of integration; a nd facilitating timely and/or sh ared resource management and

coordination of communications and information during an emergency

2. Policies and Procedures We are proposing at § 482.15(b) that a hospi tal be required to develop and implement emergency preparedness policies and procedur es based on the emergency plan proposed at § 482.15(a), the risk assessment proposed at § 482.15(a)(1), and th e communication plan proposed at § 482.15(c). These polic ies and procedures would be reviewed and updated at least annually. We are soliciting public co mment 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 st aff 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 hospitals59

were forced to meet basic subsistence needs for community evacuees, including visitors and volunteers who sheltered in plac e, resulting in the rapid depl etion of subsistence items and considerable difficulty in meeting the subsistence n eeds of patients and staff. Therefore, we are proposing that a hospital's policie s 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 outs ide the facility, have co ntracts with suppliers for the acquisition of supplies during an emergenc y, or address subsistence needs for evacuees in an agreement with a facility that was willi ng 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 subs istence 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 addresse s subsistence needs for staff and patients, we recommend that hospitals keep in mind that vo lunteers, visitors, and individuals from the community may arrive at the hospital to offer assi stance or seek shelter and consider whether the hospital needs to maintain a store of extra provi sions. 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) confer ence held in July of 2006, and from on-going participation in the CMS Survey & Certificat ion (S&C) Emergency Preparedness Stakeholder Communication Forum, that many facilities plac ed back-up generators in basements that60

subsequently became inoperable due to water dama ge. In turn, this led to possible unsafe conditions for their patients and ot her persons sheltered in the facility. We note that existing regulations at §482.41 require hospita ls to have emergency power and lighting in certain areas (operating, recovery, intensive care, emergency ro oms, 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 ward s). Power outages last ed several days after Hurricane Sandy in some areas of the northeast. Similarly, should a larg e-scale evacuation be required, a lack of emergency lighting in gene ral areas of the hospita l such as wards and corridors would greatly hinder th is process. This was of pa rticular concern in impacted healthcare facilities during Hurricane Sandy (Red lener I, Reilly M, Lessons from Sandy— Preparing Health Systems for Future Disaster s. 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 a lternate 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, extinguishi ng, and alarm systems. We are also proposing at § 482.15(b)(1)(i i)(D) that the hospital devel op policies and procedures to address provision of sewage and wa ste disposal. We are proposing to define the term "waste" as including all wastes including solid waste, re cyclables, chemical, biomedical waste and wastewater, including sewage. These proposed requirements concern assuring the continuity of the power source for the fire de tection, 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.61

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 th at the hospital be able to track a patient's whereabouts, to ensure adequate sharing of pa tient information with other providers and to inform a patient's relatives and friends of the pa tient's location within the hospital, whether the patient has been transferred to a nother facility, or what is planned in respec t to such actions. Therefore, we believe that hospi tals must develop a means to tr ack 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 associ ation 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). Th is document provides guidance for healthcare systems, healthcare coalitions and healthcare organizations emergency pr eparedness efforts that is intended to serve as a planni ng 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 outpatie nts. Such providers and suppliers would include RNHCIs, hospices, PRTFs, PACE orga nizations, LTC facilities, ICFs/IID, HHAs, CAHs, and ESRD facilities. Desp ite providing services on an outpa tient basis, we would require hospices, HHAs, and ESRD facilities to assume this responsibility. These providers and suppliers maintain current patient census in formation and would be required to provide62

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 ma intain 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 tr ansplant centers; CORFs; OPOs; clinics, rehabilitation agencies as providers of out patient physical therapy and speech-language pathology services; and RHCs/FQHCs. Transpla nt centers' patients and OPOs' potential donors would be in hospitals, and, thus, would be the ho spital's responsibility. We believe it is likely that outpatient providers and suppl iers would close their facilities prior to or immediately after an emergency, sending staff and patients home. We are not proposing a requirement for a speci fic 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 shareab le among officials within and across the emergency response system as needed in the interest of th e 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 supp liers. Lessons learned from the hurricanes in

the Gulf States revealed that some facilities, despite having pa tient-related information backed up to computer databases within or outside of th e state in which the disaster occurred, could not access the information in a timely manner. Th erefore, we would recommend that a hospital using an electronic database consider backing up its computer system with a secondary source.63

Although we believe that it is important that a hospital, and other pr oviders 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 re latives 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 ha ve policies and procedures in place to ensure the safe evacuation from the hospita l, which would include standards addressing

consideration of care an d treatment needs of evacuees; sta ff responsibilities; transportation; identification of evacuation location(s); and prim ary 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, st aff, and volunteers who remain in the facility. We expect that hospitals would include in thei r 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 hospita ls 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, wh en developing policies and procedures for sheltering in place, hospitals should consider the ab ility of their building(s) to survive a disaster and what proactive steps they could take prior to an emergency to f acilitate shelteri ng in place or transferring of patients to alternate settings if their facilitie s 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 the64

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 re quired to ensure that patient records are secure and readily available during an emergency. Such policies and procedures would have to be in complia nce with Health Insurance Portability and Accountability Act (HIPAA) Priv acy and Security Regulations at 45 CFR parts 160 and 164, which protect the privac y 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/unde rstanding/special/emergency/index.html . The tornadoes that occurred in Jop lin, Missouri in 2011, presented an example of the value of electronic health records during a disaster. Ther e 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 opera tions very quickly. We propose at § 482.15(b)(6) that facilities w ould have to have policies and procedures in place to address the use of volunteers in an emergency or othe r emergency staffing strategies, including the process an d 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 a ssistance from the Medical Reserve Corps (MRC), a national network of community-based volunt eer units that focus on improving the health, safety and resiliency of their local co mmunities. MRC units organize and utilize public health, medical and other volunteers to support existing local agencies with public health activities throughout th e year and with preparedness and resp onse activities for times of need.65

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 Emerge ncy System for Advance Registration of Volunteer Health Professionals (ESAR-VHP), found in section 107 of the Public Hea lth 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 federa l program to establish and implement guidelines and standards for the registrati on, 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 th e use of volunteers at all tiers of response (local, regional, state, intersta te, and federal). The ESAR-VHP program has been working to establish a national network of state-based progr ams 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 volunt eer's identity and credentials to hospitals and

other health care faci lities in need of the volunteer's servi ces. Each state's ESAR-VHP system is

built to standards that will allo w quick and easy exchange of health professionals with other states. We propose at § 482.15(b)(7) that hospita ls 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.66

We believe this requirement should apply onl y to providers and suppliers that provide

continuous care and services for individual patients. Thus, we ar e not proposing this requirement for transplant centers; CORFs; OPOs; clinics, re habilitation agencies, and public health agencies as providers of outpatient phys ical therapy and speech-la nguage 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 tr eatment at an altern ate care site (ACS) identified by emergency management officials. We propose this requirement for inpatient providers only. We would expe ct that state or local emerge ncy management officials might designate such alternate sites, and would plan jointly with loca l providers on issues related to staffing, equipment and supplies at such alternate sites. This requirement encourages providers to collaborate with their local emergency offi cials in such proactive planning to allow an organized and systematic response to assure con tinuity 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 cer tain Medicare, Medicai d, 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 th e 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 fr om sanctions (absent any determination of fraud or abuse). Requirements to which an 1135 waiver may apply includ e Medicare conditions of participation or conditions for coverage and requirements under the Emergency Medical67

Treatment and Labor Act (EMTALA). The 1135 wa iver authority applies only to specific federal requirements and does not apply to any state requirements, including licensure. In determining whether to invoke an 1135 wa iver (once the conditi ons 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 Wa iver”, and located at: http://www.cms.gov/AboutCMS/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 perm itted 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 fr om specific requirements.

When a waiver has been issued under secti on 1135(b)(3) of the Act, EMTALA sanctions do not apply to a hospital with a dedicated em ergency department, provi ding 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 pande mic infectious dis ease situation (see 42 CFR 489.24(a)(2)(ii)). Furthe r 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 State68

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 consis tent with the ASPR's expectation that hospital grant awardees will continue to develo p and improve their `` (ACS) plans and concept of operations for providing supplemental surge cap acity within the health care system in their state. Further discussion of ASPR's expect ation for ACSs can be found in the annual grant guidance on the web at: http://www.phe.gov/Preparedness /planning/hpp/Pages/funding.aspx

. With respect to states, ASPR stresses that effective planning a nd implementation would depend on close collaboration among state and local health departments (for example, state public health agencies, state Medicaid agen cies, and state survey agencies), provider associations, community partners , and neighboring and regional he alth-care facili ties. ASPR recommends that using existing buildings and infra structure as ACSs would be the most practical solution if a surge medical care facility were needed. When identifying sites, states should

consider how ACSs will interface with other state and federal asse ts. Federal assets may require what ASPR describes as an "environment of opp ortunity" for set up and operation and might not be available for as long as 72 hours. Therefore, ASPR believes it is cr itical that healthcare facilities, public health systems and emerge ncy management agencies work with other emergency response partners when choosing a facil ity to use as an ACS. Many of the partners (for example, the American Red Cross) may have already identified sites that would be used during an event. While our discussion is geared toward the stat e level response, we e xpect that hospitals would operationalize these efforts by working closely with the federal, state, tribal, regional, and69

local communities. According to AHRQ's "Providing Mass Medical Care with Scarce Resources: A Community Planni ng Guide," the impact of an MC E of any significant magnitude will likely overwhelm hospitals and other trad itional venues for health care services. AHRQ believes an MCE may render such venues inoperabl e, necessitating the establishment of ACSs for the provision of care that norm ally would be provided in an i npatient facility. According to AHRQ, advance planning is critical to the es tablishment and operation of ACSs; this planning must be coordinated with existing health care fa cilities, as well as home care entities. Planners must delineate the specific medical functions a nd treatment objectives of the ACS. Finally, AHRQ asserts that the principle of managing pati ents under relatively au stere conditions, with limited supplies, equipment, and access to pha rmaceuticals and a minimal staffing arrangement, is the starting point for ACS planning. Further discussion of the issues and challeng es of establishing a nd operating ACSs during an MCE, as well as specific case study exampl es of ACSs in operation during the response to Hurricane Katrina, can be found in Chapter VI of the AHRQ publication. The chapter discusses issues surrounding non-federal, non-hos pital-based ACSs. It descri bes different types of ACSs, including critical issues and deci sions that will need to be made regarding these sites during an MCE; addresses potential ba rriers; and includes examples of case studies. Subsequently, on October 1, 2009, AHRQ released two Disaster Altern ate Care Facility Selection Tools, entitled the "Disaster Alternat e Care Facility Selection Tool" and the "Alternate Care Facility Patient Selection Tool to help em ergency planners and responders select and run

alternate care facilities duri ng disaster situations. Thes e two tools can be found at: http://archive.ahrq.gov/prep/acfselection/psel ectmatrix/(S(fidfow2u5az1o155srb0h1nb))/default. aspx and at:70

http://archive.ahrq.gov/prep/acfselection/acf tool/(S(o53i55e3v452tl550uxv m055))/default.aspx

. Under contract to AHRQ, Denver Health develope d these new tools for AHRQ as an update to a previous alternate care site se lection tool, entitled the Rocky Mountain Regional Care Model for Bioterrorist Events, which it deve loped in 2004 and can be found at: http://archive.ahrq.gov/re search/altsites.htm#down . AHRQ led development of the tools with funding from the ASPR National Hospital Prep aredness Program (HPP), formerly the HRSA Bioterrorism Hospital Pr eparedness Program.

3. Communication Plan For a hospital to operate effectively in an emergency situation, we propose at § 482.15(c) that the hospital be required to develop and maintain an emergency preparedness communication plan that complies with both fede ral and state law. The hospital would be required to review and update the communication plan at least annually. As part of its communication plan, the hospi tal would be required at § 482.15(c)(1) to include in its plan, names and contact informa tion for staff; entities providing services under arrangement; patients' physicians; other hospitals ; and volunteers. During an emergency, it is critical that hospitals ha ve a system to contact appropriate st aff, patients' treating physicians, and other necessary persons in a timely manner to en sure continuation of patient care functions throughout the hospital and to ensure that these f unctions are carried out in a safe and effective manner. We propose at § 482.15(c) (2) requiring hospitals to have contact information for federal, state, tribal, regional, or local emer gency preparedness sta ff and other sources of

assistance. Patient care must be well-coordina ted within the hospital, 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. Again, we support hospitals and other71

providers engaging in coalitions in their area for assistance in effectively meeting this requirement. We propose to require at § 482.15(c)(3) that hos pitals have primary and alternate means for communicating with the hospital' s staff and federal, state, trib al, regional, or local emergency management agencies, because in an emergenc y, a hospital's landline telephone system may not be operable. While we do not propose specifyi ng the type of alternat e communication system that hospitals must have, we would expect th at facilities would c onsider pagers, cellular telephones, radio transceivers (that is, walkie-talkies), and various other radio devices such as the

NOAA Weather Radio and Amateur Ra dio Operators' (HAM Radio) systems, as well as satellite telephone communications systems. In areas wh ere available, satellite telephone communication systems may be useful as well. We recognize that some hospitals, especially in remote areas, have difficulty using some current communication systems, such as cellular phones, even in non-emergency situations. We would expect these hospitals to address such challenges when establishing and maintaining a well-designed communication system that will function during an emergency. The National Communication System (NCS) offers a wide range of National Security and Emergency Preparedness (NS-EP) communications services that suppo rt qualifying federal, state, local, and tribal govern ments, industry, and non-profit organizations in the performance of their missions during emergencies. Hospitals may seek further information on the NCS' programs for Government Emergency Te lecommunications Services (GETS), Telecommunications Service Priority (TSP) Pr ogram, Wireless Priority Service (WPS), and Shared Resources (SHARES) High Fr equency Radio Program at: www.ncs.gov . (Click on "services").72

Under this proposed rule, we would also re quire at § 482.15(c)(4) th at hospitals have a method for sharing information and medical documen tation for patients under the hospital's care, as necessary, with other health care providers to ensure continuity of care. Sharing of patient

information and documentation was found to be a significant problem dur ing the 2005 hurricanes and flooding in the Gulf Coast States. In some hospitals, patient care in formation in hard copy

and electronic format was dest royed by flooding while, in others, patient information that was backed up to alternate sites was not always readil y available. As a result, some patients were discharged or evacuated from facilities wit hout adequate accompanying medical documentation of their conditions for other providers and suppliers to utilize. Other patients who sheltered in place were also left without proper medical documen tation of their care while in the hospital. We would expect hospitals to have a system of communication that would ensure that comprehensive patient care information would be disseminated across providers and suppliers in a timely manner, as needed. Such a system woul d ensure that information was sent with an evacuated patient to the next care provider or supplier, information woul d be readily available for patients being sheltered in place, and electron ic information would be backed up both within and outside the geographic area wh ere the hospital was located. Health care providers, who were in a ttendance during the Em ergency Preparedness Summit in New Orleans, Louisiana in March 20 07, discussed the possibility of storing patient care information on flash drives, thumb devices, co mpact discs, or other portable devices that a patient could carry on his or her person for read y accessibility. We would expect hospitals to consider the range of options th at are available to them, but we are not proposing that certain specific devices would be required because of the associated burden and the potential

obsolescence of such devices.73

We propose at § 482.15(c)(5) that hospitals have a means, in the ev ent of an evacuation, to release patient information as permitted under 45 CFR 164.510 of the HIPAA Privacy Regulations. Thus, hospitals would need to ha ve a communication system in place capable of generating timely, accurate information that could be disseminated, as permitted, to family

members and others. Section 164.510 "Uses and disclosures requiring an opportunity for the individual to agree to or to object," is part of the "Standard s for Privacy of Individually Identifiable Health Information," co mmonly known as "The Privacy Rule." This proposed requirement would not be appl ied to transplant cen ters; CORFs; OPOs; clinics rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech-language pathology services; or RHCs/FQHCs. We believe this requirement would best be applied only to providers and supp liers who provide continuous care to patients, as well as to those providers and suppliers that ha ve responsibilities and oversight for care of patients who are homebound or receiving services at home. We propose at § 482.15(c)(6) requiring hosp itals to have a means of providing information about the general condition and loca tion of patients under the facility's care, as permitted under 45 CFR 164.510(b)(4) of the HIPAA Privacy Regulations. Section 164.510(b)(4), "Use and disclosures for disaster relief purposes," establ ishes requirements for disclosing patient information to a public or privat e entity authorized by law or by its charter to assist in disaster relief efforts for pur poses of notifying family members, personal representatives, or certain othe rs of the patient's location or general condition. We are not proposing prescriptive requirement s for how a hospital would comply with this requirement. Instead, we would allow hospitals the flexibility to develop and maintain their own system.74

We propose at § 482.15(c)(7) that a hospital ha ve a means of providing information about the hospital's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction or the Inci dent Command Center, or designee. We support hospitals and other providers engaging in coalitions in their area for assistance in effectively meeting this requirement. 4. Training and Testing We propose at § 482.15(d) that a hospital develop and maintain an emergency preparedness training and testing program. We would require the hospita l to review and update the training and testing progr am at least annually. We believe a well organized, e ffective training program must include providing initial training in emergency prepare dness policies and procedures. Therefore, we propose at § 482.15(d)(1) that hospitals provide such training to all new a nd existing staff, including any individuals providing services under arrangement, and volunteers, c onsistent with their expected roles, and maintain documentation of such traini ng. We propose that the hospital ensure that staff can demonstrate knowledge of emergency pr ocedures, and that the hospital provides this training at least annually. While some large hospitals may have staff th at could provide such training, smaller and rural hospitals may need to find resources outside of the hospital to provide such training. Many state and local governments can provide emerge ncy preparedness training upon request. Thus, small hospitals and rural hospitals may find it help ful to utilize the resources of their state and local governments in meeting this requirement. Again, we support hospitals and other providers participating in coalitions in their area for a ssistance in effectively meeting this requirement. Conducting exercises at the health care coalition level could help to reduce the administrative75

burden on individual healthcare facilities and demonstrate the value of connecting into the broader medical response community during di saster planning and response. Conducting integrated planning with state and local entities could identify potential ga ps in state and local capabilities. Regional planning co alitions (multistate coalitions) meet and provide exercises on a regular basis to test pr otocols for state-to-state mutual aid. The members of the coalitions are often able to test command and control procedur es and processes for sharing of assets that promote medical surge capacity. Regarding testing, at § 482.15(d )(2), we would require hospi tals to conduct drills and exercises to test the emergenc y plan. We propose at § 482.15(d)(2 )(i) requiring hospitals to participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, we would require the hospita l to conduct an individu al, facility-based mock disaster drill at least annually. However, we propose at § 482.15(d)(2)( ii) that if a hospital experienced an actual natural or man-made emer gency that required activation of the emergency plan, the hospital would be exempt from engaging in a community or indi vidual, facility-based mock disaster drill for 1 year following the actual event. We propose at § 482.15(d)(2)(iii) requiring a hospital to conduct a paper-based, tabletop exercise at least annually. The tabletop exerci se could be based on the same or a different

disaster scenario from the scenario used in the mock disaster drill or th e actual emergency. In the proposed regulations text, we would define a tabletop exercise as a "group discussion led by a facilitator, using a narrated, clinically-releva nt emergency scenario, and a set of problem statements, directed messages, or prepared quest ions designed to challenge an emergency plan." Comprehensive emergency preparedness include s anticipating and ad equately addressing

the various natural and man-made disasters that c ould impact a given facility. We expect that76

hospitals would conduct both mock disaster dril ls and tabletop exer cises, using various emergency scenarios, based on their risk analyses. Generally, in a mock disaster drill, a hospital must consider how it will move persons within and outside of the building to designate d "safe zones" to ensure the safety of both ambulatory patients and those who are wheelchair users, have mobility impairments or have other special needs. Moving patients or mock patie nts to "safe zones" in and outside of buildings during fire drills and other mock disaster drills is common industry practic e. However, if it is not feasible to evacuate patients, hospitals c ould meet this requirement by moving its special needs patients to "safe zones" such as a foyer or other areas as designa ted by the hospital. To assist hospitals, other providers, and suppliers in conducting table-top exercises, we sought

additional resources to further de fine the actions involved in a paper-based, tabletop exercise. One hospital system representative described a ta bletop exercise as one where the staff conducts, on paper, a simulated public health emergency that would impact the hospital and surrounding health care facilities. For this hospital, th e tabletop exercise is a half-day event for representatives of every critical response area in the hospital. It is designed to test the effectiveness of the response plan in guiding the leader ship team's efforts to coordinate the

response to an emergency event. The hospital representative fu rther explained that the ex ercise consists of a group discussion led by a facilitator, us ing a narrated, clinical ly-relevant scenario, and a set of problem statements, directed messages, or prepared quest ions designed to challenge an emergency plan. Exercise facilitators introduce the scenario, keep the exercise on schedule, and inject timed challenges to stress specific disaster response systems. Fo llowing the tabletop exercise, a77

debriefing for hospital staff is held, and then the hospital staff provide s written feedback and planning improvement suggestions to the hospital administration. Some hospitals may be well-versed in perfor ming mock drills and tabletop exercises. Other providers and suppliers, especially those that are small or remote, may not have any knowledge or hands-on experience in conducting such exercises. To this end, the Bureau of Communicable Disease in the New York City De partment of Health and Mental Hygiene has produced a very detailed document entitled, "Bio event Tabletop Exercise Toolkit for Hospitals and Primary Care Centers," (September 2005, found at: http://www.nyc.gov/html/doh/downloads/pdf /bhpp/bhpp-train-hospital-toolkit-01.pdf ), which may help hospitals and other providers and s uppliers that have limited or no emergency preparedness training experience. This documen t is designed to walk a facility through the process of performing a tabletop exer cise and after-event analysis. The toolkit consists of things to consider before engaging in a tabletop exercise, the process of planning the exercise, running the exercise, evaluating the exercise and its im pact, and public health emergency scenarios for tabletop exercises, including the plague, Seve r Acute Respiratory Synd rome (SARS), anthrax, smallpox, and pandemic flu. There are also other training resources that may prove useful for hospitals and other providers and suppliers to comply with as th ey attempt to meet this proposed emergency preparedness requirement. In 2005, the RAND Co rporation produced a technical report for ASPR entitled, "Bioterrorism Preparedness Traini ng and Assessment Exercises for Local Public Health Agencies," by Dausey, D. J., Lurie, N., Al exis, D., Meade, B., Molander, R. C., Ricci, K. A., Stoto, M. A., and Wasserman, J. ( http://www.rand.org/pubs/tec hnical_reports/2005/RAND_TR261.pdf ).78

The report was intended as a resource to train public health workers to detect and respond

to bioterrorism events and to a ssess local public health agencies ' (LPHAs) levels of preparedness

over time. The exercises were beta tested and re fined in 13 LPHAs across the United States over 10 months. However, the report would be a usef ul resource for hospitals and other healthcare

facilities to train their own healthcare workers. RAND also developed a 2006 technical report entitled, "Tabletop Exercise for Pandemic Influenza Preparedness in Local Public Health Ag encies," by Dausey, D.J ., Aledort, J. E., and Lurie, N. ( http://www.rand.org/pubs/technical _reports/2006/RAND_TR319.pdf ). The report was designed to provide state and local public health agencies and their healthcare and governmental partners with exer cises in training, building rela tionships, and evaluation. These exercises were pilot-tested at three metropolitan -area local public health agencies in three separate states from August through November 2005. Finally, the Centers for Medicare & Medicaid Services (CMS), Survey and Certification Group has developed a document entitled, the Health Care Provider After Action Report/Improvement Plan (AAR/IP) template with the assistance of the U.S. Department of Health and Human Services (HHS ), Office of the Assistant S ecretary for Preparedness and Response, the U.S. Department of Homeland Security (DHS), and the CMS Survey and Certification Emergency Preparedness Stakeholde r Communication Forum. The template can be

accessed at http://www.cms.gov/SurveyCertEmergPrep/03_HealthCareProviderGuidance.asp and then scrolling down to click on the download entitled, the "Health Care Provider Voluntary After Action Report/Improvement Plan Template and Instructions for Completion." The

AAR/IP was intended to be a volunt ary, user-friendly tool for hea lth care providers to use to document their performance during emergency pla nning exercises and real emergency events to79

make recommendations for improvements for future performance. We do not mandate use of this AAR/IP template; however thorough comple tion of the template complies with our requirements for provider exercise documentation.

The "Health Care Provider After Action Re port/Improvement Plan" template also meets requirements for hospitals or other health care pr oviders wishing to ensure their compliance with the Hospital Preparedness Program (HPP). This AAR/IP template is based on the U.S. Department of Homeland and Security Exercise and Evaluation Program (HSEEP) Vol. III, issued in February 2007, which includes guidelines that are focused towards emer gency management agencies and other governmental/non-governmental ag encies. The HSEEP is a capab ilities and performance-based exercise program that provides a standardized methodology and terminology for exercise design, development, conduct, evaluati on, and improvement planning. Health care providers may also use the AAR/IP to document real life emergency events and can customize or personalize the CMS "Health Care Provider AAR/IP" templa te to best meet their needs. There are seven types of exercises define d within HSEEP, each of which is either discussions-based or operations-based. Discussions-based exercises familiarize participants with current plans, policies, agreements and procedures, or may be used to develop new plans, policies, agreements, and procedures. Types of discussion-based exer cises include the following:

● Seminar: A seminar is an informal discus sion, designed to orient participants to new or updated plans, policies, or procedures (for example, a seminar to review a new Evacuation Standard Operating Procedure).80

● Workshop: A workshop resembles a seminar, but is employed to build specific products, such as a draft plan or policy (for example, a Training and Exercise Plan Workshop is used to develop a Multiyear Trai ning and Exercise Plan).

● Tabletop Exercise (TTX): A tabletop exercise involves ke y personnel discussing

simulated scenarios in an inform al setting. TTXs can be used to assess plans, policies, and procedures.

● Games: A game is a simulation of operati ons that often involves two or more teams, usually in a competitive environment, using rule s, data, and procedure designed to depict an

actual or assumed real -life situation. Operations-based exercises validate plans, policies, agreements and procedures, clarify roles and responsibilities, and identify resource gaps in an operational environment. Types of operations-based exercises include the following:

● Drill: A drill is a coordinated, supervised activity usually employe d to test a single, specific operation or function within a single enti ty (for example, a nursing home conducts an evacuation drill).

● Functional exercise (FE) : A functional exercise examines or validates the coordination, command, and control between vari ous multi-agency coordination centers (for example, emergency operation center, joint field o ffice, etc.). A functional exercise does not involve any "boots on the ground" (that is, first responders or emergency officials responding to an incident in real time).

● Full-Scale Exercise (FSE): A full-scale exercise is a multi-agency, multi-jurisdictional, multi-discipline exercise in volving functional (for example, joint field office, emergency operation centers, etc.) and "boots on the ground" res ponse (for example,81

firefighters decontaminating mock victims). We expect hospitals to e ngage in such tabletop exercises to the extent possible in their commun ities. For example, we would expect a large hospital in a major metropolitan area to perform a comprehensive exercise with coordination, if possible, across the public health sy stem and local geographic area. We propose at § 482.15(d)(2)(iv) that hospitals analyze their response to and maintain documentation on all drills, tabletop exercises, an d emergency events, and revise the hospital's emergency plan as needed. Resources discussed previously can be used to guide hospitals in this process. Finally, we propose at §482.15(e )(1)(i) that hospitals must store emergency fuel and associated equipment and systems as required by the 2000 edition of the Life Safety Code (LSC)

of the National Fire Protection A ssociation (NFPA). We intend to require compliance with future LSC updates as may be adopted by CMS. The curre nt LSC states that the hospital’s alternate source of power (for example, generator) and al l connected distribution systems and ancillary equipment, must be designed to ensure continui ty of electrical power to designated areas and

functions of a health care facili ty. Also, the LSC (NFPA 110) states that the rooms, shelters, or separate buildings housing the emergency power s upply shall be located to minimize the possible damage resulting from disasters such as stor ms, floods, earthquakes, tornadoes, hurricanes, vandalism, sabotage and other material and equipment failures. In addition to the emergency power system inspection and testing requirements found in NFPA 99 and NFPA 110 and NFPA 101, we propose that hospitals test their emergency and stand-by-power systems for a minimum of 4 con tinuous hours every 12 months at 100 percent of the power load the hospital anticipates it will requ ire during an emergency. As a result of lessons learned from hurricane Sandy, we believe that this annual 4 hour test will more closely reflect82

the actual conditions that would be experienced during a disaster of the magnitude of hurricane Sandy. We have also proposed the same emergenc y and standby power requirements for CAHs and LTC facilities. As such, we request inform ation on this proposal an d in particular on how we might better estimate costs in light of the existing LSC and other state and federal requirements. We have included a table of requirements base d on the 5 standards in the regulation text for each of the 17 providers and suppliers. The table includes both additional requirements and exemptions. This table can be used to provi de guidance to the facilities in planning their emergency preparedness program and disaster planning.83TABLE 1--EMERGENCY PREPAREDNESS REQUIREMENTS BY PROVIDER TYPEProvider Type Emergency Plan Policies and Procedures Communication Plan Training and Testing AdditionalRequirementsInpatient ProvidersHospital *Develop a planbased on a riskassessment using an“all hazards”approach, which isan integratedapproach focusingon capacities andcapabilities criticalto preparedness for afull spectrum ofemergencies anddisasters. The planmust be updatedannually.*Develop and implementpolicies and proceduresbased on the emergencyplan and risk assessment,which must be reviewedand updated at leastannually.*Develop and maintain anemergency preparednesscommunication plan thatcomplies with both federaland state law. Patient caremust be well-coordinatedwithin the facility, acrosshealth care providers andwith state and local publichealth departments andemergency systems.*Develop and maintaintraining and testingprograms, including initialtraining in policies andprocedures and demonstrateknowledge of emergencyprocedures and providetraining at least annually.Conduct drills and exercisesto test the emergency plan.Generators--Develop policiesand proceduresthat address theprovision ofalternate sourcesof energy tomaintain: (1)temperatures toprotect patienthealth and safetyand for the safeand sanitarystorage ofprovisions; (2)emergencylighting; (3) firedetection,extinguishing,and alarmsystems.Critical AccessHospital* * * * Generators.Long Term CareFacilityMust account formissing residents(existingrequirement).* Share withresident/family/representativeappropriate information fromemergency plan (additionalrequirement).* Generators.PRTF * * * *84Provider Type Emergency Plan Policies and Procedures Communication Plan Training and Testing AdditionalRequirementsICF/IID Must account formissing clients(existingrequirement).* Share withclient/family/representativeappropriate information fromemergency plan (additionalrequirement).*RNHCI * * * No drills.TransplantCenter* * * * Maintainagreement withtransplant center& OPO.Outpatient Providers--Outpatient providers are not requiredto provide subsistence needs for staff and patients.Hospice * In home services—inform officials ofpatients in need ofevacuation (additionalrequirement).In home services--will notneed to provide occupancyinformation.*AmbulatorySurgical Center* * Will not need to provideoccupancy information.*PACE * Inform officials ofpatients in need ofevacuation (additionalrequirement).Will not need to provideoccupancy information.*Home HealthAgency* Will not require shelterin place, provision ofcare at alternate caresites.Inform officials ofpatients in need ofevacuation (additionalrequirement).Will not need to provideoccupancy information.*85Provider Type Emergency Plan Policies and Procedures Communication Plan Training and Testing AdditionalRequirementsCORF Must developemergency plan withassistance from fire,safety experts(existingrequirement).Will not need to providetransportation toevacuation locations, orhave arrangements withother CORFs to receivepatients.Will not need to provideoccupancy information.Assign specific emergencypreparedness tasks to newpersonnel. Provideinstruction in location, use ofalarm systems, signals &firefighting equip (existingrequirements).CMHC * * * *OPO Address type ofhospitals OPO hasagreement(additionalrequirement).Needs to have system totrack staff during & afteremergency and maintainmedical documentation(additional requirement).Does not need to provideoccupancy info, method ofsharing pt. info, providinginfo on general condition &location of patients.Only tabletop exercise Must maintainagreement withother OPOs &hospitals.Clinics,Rehabilitation,and TherapyMust developemergency plan withassistance from fire,safety experts.Address location,use of alarm systemsand signals &methods ofcontaining fire(existingrequirements).* Does not need to provideoccupancy information.*RHC/FQHC * Appropriate placementof exit signs (existingrequirement).Does not have to trackpatients, or havearrangements with otherRHCs to receive patientsor have alternate caresitesDoes not need to provideoccupancy information.*86Provider Type Emergency Plan Policies and Procedures Communication Plan Training and Testing AdditionalRequirementsESRD Must contact localemergencypreparedness agencyannually to ensuredialysis facility’sneeds in anemergency (existingrequirement).Policies and proceduresmust includeemergencies regardingfire equipment, powerfailures, care relatedemergencies, watersupply interruption &natural disasters(existing requirement).Does not need to provideoccupancy information.Ensure staff demonstrateknowledge of emergencyprocedures, informingpatients what to do, where togo, whom to contact ifemergency occurs whilepatient is not in facility(alternate emergency phonenumber), how to disconnectthemselves from dialysismachine. Staff maintaincurrent CPR certification,nursing staff trained in use ofemergency equipment &emergency drugs, patientorientation (existingrequirements).*Indicates that the requirements are the same as those proposed for hospitals.87

B. Emergency Preparedness Regulations for Reli gious Nonmedical Health Care Institutions (RNHCIs) (§ 403.748) Section 1861(ss)(1) of the Act defines the te rm "Religious Nonmedical Health Care Institution" (RNHCI) and lists the requirements that a RNHCI mu st meet to be eligible for Medicare participation. We have implemented these provisions in 42 CFR part 403, Subpart G, "Religious

Nonmedical Health Care Institut ions" Benefits, Conditions of Pa rticipation, and Payment." As of March 2012, there were 16 Medicare-certified RNHCIs that were subject to the RNHCI regulations and were receiving payment for services provided to Medicare or Medicaid patients. A RNHCI is a facility that is operated under al l applicable federal, state, and local laws and regulations, which furnishes only non-medi cal items and services on a 24-hour basis to beneficiaries who choose to rely solely upon a religious method of healing and for whom the acceptance of medical services would be inconsiste nt with their religious beliefs. The religious non-medical care or religious method of heali ng means care provided under the established religious tenets that prohibit c onventional or unconventional medical care for the treatment of the patient and exclusive reliance on the re ligious activity to fulfill a patient's total health care needs. Thus, Medicare would cover the nonmedical, non -religious health care items and services in a RNHCI for beneficiaries who would qualify fo r hospital or skilled nu rsing facility care but

for whom medical care is inconsistent with thei r religious beliefs. Medi care does not cover the religious aspects of care

. Nonmedical items and services are furnished to inpatients exclusively through nonmedical nursing personnel. Such Medi care coverage would in clude both nonmedical items that do not require a doctor's order or pr escription (such as wound dressings or use of a88

simple walker during a stay) and non-religious health ca re items and services (such as room and board).

The RNHCI does not furnish medical items and services (including any medical screening, examination, diagnosis, prognosis, trea tment, or the administration of drugs or biologicals) to its patients. RNHCIs must not be owned by or under common ownership or affiliated with a provider of medical treatment or services. This proposed rule would expand the current emergency preparedness requirements for RNHCIs, which are located with in § 403.742, Condition of participa tion: Physical Environment, by requiring RNHCIs to meet the same proposed emergency preparedness requirements as we propose for hospitals, with several exceptions. Our "Physical environment" CoP at § 403.742( a)(1) currently requi res that the RNHCI provide emergency power for emergency lights, for fire detection and alarm systems, and for fire extinguishing systems. Secti on 403.742(a)(4) requires th at the RNHCI have a written disaster plan that addresses loss of wa ter, sewage, power and other em ergencies. Section 403.742(a)(5) requires that a RNHCI have facilities for emergency gas and water supply. We propose relocating the pertinent portions of the existing requirements at § 403.742(a)(1),(4 ),and (5) at proposed § 403.748(a) and § 403.748(b)(1). However, we believe these current requirements do not provide a sufficient framewor k for ensuring the health and sa fety of a RNHCI's patients in

the event of a natural or man-made disaster. Proposed § 403.748(a)(1) would require RNHCIs to consider loss of power, water, sewage and waste disposal in their risk anal ysis. The proposed polic ies and procedures at § 403.748(b)(1) would require that RN HCIs provide for subsistence needs for staff and patients, whether they evacuate or shelter in place, incl uding, but not limited to, food, water, sewage and89

waste disposal, non-medical supplie s, alternate sources of energy for the provision of electrical power, the maintenance of temperatures to protect patient health and safety and for the safe and sanitary storage of such provisions, gas, emer gency lights, and fire detection, extinguishing, and alarm systems. The proposed hospital requirement at § 482.15(a) (1) would be modified for RNHCIs. At proposed § 403.748(a)(1), unlike for other providers and suppliers whom we propose to have a community risk assessment that is based upon an all-hazards approac h, including the loss of power, water, sewage and waste disposal. Ho wever, at proposed § 403.748(b)(1)(i) for RNHCIs,

we have removed the terms "medical and nonmed ical" to reflect typi cal RNHCI practice. RNHCIs do not provide most medi cal supplies. At § 482.15(b)(3), we would require hospitals to have policies and procedures for the safe evacu ation from the hospital, which would include

consideration of care an d treatment needs of evacuees; sta ff responsibilities; transportation; identification of evacuation location(s); and prim ary and alternate means of communication with external sources of assistance. However, at § 403.748(b)(3), we propos e to incorporate the hospital requirement but to remove the words "and treatment" from the hospital requirement, to more accurately reflect care provided in a RNHCI. At proposed § 403.748(b)(5), we would remove the term "health" from the proposed hospital requirement for "health care documentati on" to reflect the non-medical care provided by

RNHCIs. The proposed hospital requirements at § 482.15( b)(6) would require hospitals to have policies and procedures to addr ess the use of volunteers in an emergency or other staffing strategies, including the process a nd role for integrati on of state or federally designated health care professionals to address surge needs duri ng an emergency. For RNHCIs, at proposed90

§ 403.748(b)(6), we propose to use the hospital provision, but remove the language, "including the process and role for integration of state or federally designated he alth care professionals" since it is not within the religious framework of a RNHCI to integrate care issues for their patients with health care professiona ls outside of the RNHCI industry. The proposed hospital requirements at § 482.15(b)(7) would require that hospitals develop arrangements with other hos pitals and other providers to re ceive patients in the event of limitations or cessation of operations to ensure the continuity of serv ices to hospital patients. For RNHCIs, at § 403.748(b)(7) we added the term "non-medical" to accommodate the uniqueness

of the RNHCI non-medical care. The proposed hospital requirement at § 482.15(c)(1 ) would require hospitals to include in their communication plan: names and contact inform ation for: staff; entities providing services under agreement; patients' physicians; other hospita ls; and volunteers. For RNHCIs, we propose substituting "next of kin, guardian or custodi an" for "patients' physicians" because RNHCI patients do not have physicians. Finally, unlike proposed regulations for hospitals at § 482.15(c)(4), at proposed § 403.748(c)(4), we propose to re quire RNHCIs to have a method for sharing information and care documentation for patients under the RNHCIs' care, as necessary, with health care providers to ensure continuity of care, based on the writte n election statement made by the patient or his or her legal representative. Als o, at proposed § 403.748(c)(4), we have removed the term "other" from the requirement for sharing information with "other health care providers" to more accurately reflect the ca re provided by RNHCIs. At § 482.15(d)(2), "Testing," we propose that hospitals would conduct drills and exercises to test the emergency plan. Because RNHCIs have such a specific role and provide91

such a specific service in the community, we believe RNHCIs would not participate in performing such drills. We propose the RNHC I would be required to only conduct a tabletop exercise annually. Likewise, unlike that which we have proposed for hospitals at § 482.15(d)(2)(i), we do not propose that the RNHCI conduct a community mock disaster drill at least annually or to conduct an individual, faci lity-based mock disast er drill. Although we proposed for hospitals at § 482.15(d) (2)(ii) that if the hospital e xperienced an actual natural or man-made emergency, the hospital would be exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year followi ng the onset of the actual event, we are not proposing this requirement for RNHCIs. At § 482.15(d)(2)(iv), we propose to require hos pitals to maintain documentation of all drills, tabletop exercises, and emergency events , and revise the hospital's emergency plan, as needed. Again, at § 403.748(d)(2)(d )(ii), for RNHCIs, we propose to remove reference to drills. Currently, at existing § 403.724(a), we require that an election form be made by the Medicare beneficiary or hi s or her legal representative and furt her requires that the election must be a written statement that the beneficiary: (1) is conscientiously opposed to accepting non-excepted medical treatment; (2) believes that non-excepted medical treatment is inconsistent with his or her sincere religious beliefs; (3) understands that acceptance of non-excepted medical

treatment constitutes revocation of the election and possible limitation of receipt of further services in a RNHCI; (4) knows that he/she may revoke the election by submitting a written statement to CMS, and (5) knows that the elec tion will not prevent or delay access to medical

services available under Medica re Part A in facilities othe r than RNHCIs. Thus, at § 403.748(c)(4), we are proposing that election do cumentation be shared with other care providers to preserve continuity of care.92

C. Emergency Preparedness Requirements for Ambulatory Surgical Centers (ASCs) (§ 416.54) Section 416.2 defines an ambulatory surgical center (ASC) as any di stinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization, and in which th e expected duration of services would not exceed 24 hours following an admission. Section 1833(i)(1)(A) of the Ac t authorizes the Secretary to specify those surgical procedures that can be performed safely in an ASC. The surgical services performed in ASCs generally are scheduled, elective, non-life-threatening pro cedures that can be safely performed in either a hospital setting (inpatient or outpat ient) or in a Medicare-certified ASC. Patients are examined immediately before surger y to evaluate the risk of anesthesia and of the procedure to be performed. Patients also are evaluated just prior to discharge from the ASC to ensure proper anesthesia recovery. Currently, there are 5,354 Medicare certified ASCs in the U.S. The ASC Conditions for Coverage (CfCs) at 42 CFR part 416, Subpart C ar e the minimum health and safety standards a facility must meet to obtai n Medicare certification. The ex isting ASC CfCs do not contain requirements that address emergency situations . However, existing § 416.41(c), which was adopted in November 2008, requires ASCs to have a disaster preparedness plan. This existing requirement states the ASC must--(1) have a written disaster plan that provides for the emergency care of its patients, sta ff and others in the facility; (2) coordinate the plan with state and local authorities; and (3) conduct drills, annually and comple te a written evaluation of each drill, promptly implementing any correction to the plan. Since these proposed requirements are

similar to and would be redundant with exis ting rules, we propose to remove existing § 416.41(c). Existing § 416.41(c)(1 ) would be incorporated in to proposed § 416.54(a), (a)(1),93

(a)(2), and (a)(4). Existing § 416.41(c)(2) would be incorporated into proposed § 416.54(a)(4)and (c)(2). Existing § 416.41(c)(3) would be incorporated into proposed § 416.54(d)(2)(i) and § 416.54(d)(2)(iv). This proposed regulation woul d require the ASC to meet most of the same proposed emergency preparedness requirements as those we propose for hospitals, with two exceptions. At § 416.54(c)(7), we propose that ASCs would be required to have policies and procedures that include a means of providing information about the ASCs' needs and its ability to provide assistance (such as physical spa ce and medical supplies) to th e authority having jurisdiction (local, state agencies) or the Incident Command Cent er, or designee. However, we are not proposing that these facilities provide inform ation regarding their occupancy, as we have proposed for hospitals, since the term "occupanc y" usually refers to bed occupancy in an inpatient facility. We are not proposing that th ese facilities provide fo r subsistence needs for their patients and staff. While a large ASC in a metropolitan area may find it relatively easy to perform a risk analysis and develop an emergency plan, polic ies and procedures, a communications plan, and train staff, we understand a small or rural ASC may find it more challenging to meet our proposed requirements. However, we believe th ese requirements are important and small or rural ASCs would be able to develop an appropr iate emergency preparedness plan and meet our proposed requirements with the assistance of resour ces in their state and local community guidance. D. Emergency Preparedness Regulations for Hospices (§ 418.113) Section 122 of the Tax Equity and Fiscal Responsibility Ac t of 1982 (TEFRA), Pub. L. 97–248, added section 1861(dd) to the Act to provide coverage for hospice care to94

terminally ill Medicare beneficiaries who elect to receive care from a Medicare-participating hospice. Under the authority of section 1861(dd) of the Act, the Secretary has established the CoPs that a hospice must meet in order to part icipate in Medicare and Medicaid. Under section 1861(dd) of the Act, the Secret ary is responsible for ensuri ng that the CoPs and their enforcement are adequate to protect the health and safety of patients under hospice care. To implement this requirement, state survey agen cies conduct surveys of hospices to assess their compliance with the CoPs. The CoPs found at pa rt 418, Subparts C and D a pply to a hospice, as

well as to the services furnished to each patient under hospice care. Hospice care provides palliative care rather than traditional medical care and curative treatment to terminally ill patients. Palliative care improves the quality of life of patients and their families facing the problems associated with terminal illness through the prevention and relief of suffering by means of early identificat ion, assessment, and treatment of pain and other issues. Hospice care allows the patient to remain at home as long as possible by providing support to the patient and family and by keeping the patient as comfortable as possible while maintaining his or her dignity and quality of life. Hospices use an interdisciplinary approach to deliver medical, social, physical, emotional, a nd spiritual services th rough the use of a broad spectrum of caregivers. Hospices are unique health care providers because they serve patients and their families in a wide variety of settings. Hospice patients ma y be served in their plac e of residence, whether that residence is a private home, a nursing home, an assisted living facility, or even a recreational vehicle, as long as such locations are determined to be the patient's place of residence. Hospice patients may also be served in inpatie nt facilities opera ted by the hospice.95

As of March 2013, there were 3,773 hospice fac ilities nationally. Under the existing hospice regulations, hospice inpatient facilities are required to have a written disaster preparedness plan that is peri odically rehearsed with hospice em ployees, with procedures to be

followed in the event of an intern al or external disaster, and pro cedures for the care of casualties (patients and staff) arisi ng from such disasters. This requir ement, which is limited in scope, is found at § 418.110(c)(1)(ii) under "Standa rd: Physical environment." We believe that all hospices, even those w ithout inpatient facilities, should have an emergency plan. Also, we belie ve that, given the diverse natu re of hospice patients and the variety of locations where they receive hospice se rvices, simply having a written plan that is "periodically" rehearsed with staff does not pr ovide sufficient protecti on for hospice patients and hospice employees. For hospices, we propose to retain existing re gulations at § 418.110(c)(1)(i), which states that a hospice must address real or potential threats to the health and safety of the patients, others, and property. However, we propose incorporating the existing requirements at § 418.110(c)(1)(ii) into proposed § 418.113(a)(2 ) and proposed § 418.113(d)(1). We would require at § 418.113(a)(2) that the hospice have in effect an em ergency preparedness plan for managing the consequences of power failures, na tural disasters, and other emergencies that would affect the hospice's ability to provide care. In addition, we would require at § 418.113(d)(1) that the hospice must periodica lly review and rehearse its emergency preparedness plan with hospice employees wi th special emphasis placed on carrying out the procedures necessary to pr otect patients and others. Section 418.110(c)(1)(ii) and the designation for clause § 418.110(c) (1)( i) would be removed.96

Otherwise, the proposed emergency prepare dness requirements for hospice providers are very similar to those for hospitals. However, the average hospice (fre estanding, not-for-profit, with far fewer annual admissions, and employees) is very different from an average hospital. Typically, hospice inpatient facilities are small buildings or a single unit in a larger medical complex, such as a hospital or long term care fac ility. Furthermore, hospice patients, given their terminally ill status, may be equally or more vulnerable in an emergency situation than their hospital counterparts. This may be due to the inherent severity of the hospice patient's illness or to the probability that the hospice patient's ca regiver may not have the level of professional expertise, supplies, or equipment as that of the hospital-based clinician surrounding a natural or man-made emergency. Despite these core differences, we belie ve the hospital emergency preparedness requirement, with some reorganization and revision, is appropriate for hospice providers. Thus, our discussion will focus on the requirements as they differ from the requirements for hospitals within the context of the hospice setting. Since hospices serve patients in both the community and within various types of fac ilities, we propose to re-organize the requirements for the hospice provider's policies and procedures differently from the proposed policies and procedures for hospitals. Specifically, we propose to group requir ements that apply to all hospice providers at § 418.113(b)(1) through § 418.113(b)(5) followed by re quirements at § 418.113(b)(6) that apply only to hospice inpatient care facilities. Unlike our proposed hospital policies and pr ocedures, we would require all hospices, regardless of whether or not they operate their own inpatient fa cilities, to have policies and procedures to inform state and local officials a bout hospice patients in need of evacuation from their respective residences at any time due to an emergency situation based on the patient's97

medical and psychiatric condition an d home environment. Such policies and procedures must be in accord with the HIPAA Privacy Rule, as appr opriate. This proposed requirement recognizes that many of the frail hospice patients may be unable to evacuate from their homes without assistance during an emergency. This addi tional proposed requirement recognizes the responsibility of the hospice to supp ort the safety of its patients th at reside in the community. We expect that hospices would be able to id entify patients most in need of evacuation assistance (for example, patients residing alone and patients using certa in types of durable medical equipment), safe and appropriate evacua tion methods, and the appr opriate state or local

authorities to assist in such ev acuations. We believe this requirement is necessary to ensure the safety of vulnerable hospice patients, who ar e likely not capable of evacuating without

assistance. We note that the proposed requirements fo r communication at § 418.113(c) are the same as for hospitals, with the exception of propos ed § 418.113(c)(7). At § 418.113(c)(7), for hospice facilities, we are proposing to lim it to inpatients the proposed requi rement that the hospice have policies and procedures that w ould include a means of providing information about the hospice's occupancy and needs, and its ability to provide as sistance, to the authority having jurisdiction or

the Incident Command Cent er, or designee. Since hospice facil ities provide care to patients in the home or in an inpatient setting, we are pr oposing that only inpatien t hospice facilities, including those under arrangement, be required to report the hospice f acilities' inpatient occupancy. The proposed requireme nts for patients receiving car e in their home would require only that hospices report their needs and ab ility to provide assi stance. The proposed requirements for training and testing at §418.113(d) are similar to those proposed for hospitals.98

E. Emergency Preparedness Regulation for I npatient Psychiatric Residential Treatment Facilities (PRTFs) (§ 441.184) Sections 1905(a)(16) and (h) of the Act define the term "Psychiatric Residential Treatment Facility" (PRTF) and list the requirements that a PRTF must meet to be eligible for Medicaid participation. To qualify for Medicaid participation, a PRTF must be certified and comply with conditions of payment and conditi ons of participation (C oPs), at § 441.150 through § 441.182 and § 483.350 through § 483.376 respectively. As of March 2013, there were 387

PRTFs. A PRTF provides inpatient psychiatric servi ces for patients under age 21; services must be provided under the direction of a physician. In patient psychiatric services must involve active treatment which means implementation of a profe ssionally developed and s upervised individual plan of care. The patient's plan of care includes an integrated program of therapies, activities, and experiences designed to meet individual trea tment objectives that have been developed by a team of professionals along with the patient, his or her parents, legal guardians, or others into whose care the patient will be released after discharge. The plan must also include post-discharge plans and coordination with commun ity resources to ensure continued services for the patient, his or her family, school, and community. The current PRTF requirements do not in clude any requirements for emergency preparedness. We propose requiring that PRTF f acilities meet the same requirements we are proposing for hospitals. Because these facilities vary widely in size, we expect their risk analyses, emergency plans, emergency polic ies and procedures, emergency communication plans, and emergency preparedness training will vary widely as well. Nevertheless, we believe each of these providers/suppliers ha s the capability to comply fully with the requirements so that99

the health and safety of its pa tients are protected in the even t of an emergency situation or

disaster. F. Emergency Preparedness Regulations for Prog rams of All-Inclusive Care for the Elderly (PACE) (§ 460.84) The Balanced Budget Act (BBA) of 1997 estab lished the Program of All-Inclusive Care for the Elderly (PACE) as a permanent Medicare and Medicaid provider type. Under sections 1894 and 1934 of the Act, a state pa rticipating in PACE must ha ve a program agreement with CMS and a PACE organization. Regulations at § 460.2 describe the statutory authority that permits entities to establish and operate PA CE programs under section 1894 and 1934 of the Act and § 460.6 defines a PACE organization as an entity that has in effect a PACE program agreement. Sections 1894(a)(3) and 1934(a)(3) of the Act define a "PACE provider." The PACE model of care was adopted from On Lok Se nior Health Services, an organization that

continues to serve seniors in San Francisco and surrounding areas of Califo rnia. It is a unique model of managed care service delivery for th e frail community-dwelling elderly. The PACE model of care includes the provi sion of adult day health care a nd interdisciplinary team care management as core services. Medical, therapeu tic, ancillary, and soci al support services are furnished in the patient's reside nce or on-site at a PACE cente r. Hospital, nursing home, home health, and other specialized services are generally furnished under contract. Generally, a PACE organization provides medi cal and other support services to patients predominately in a PACE adult day care center . Day center attendance is based on individual needs. The majority of PACE patients go to a PA CE adult day health center on a regular basis. On average, a PACE patient attends the day cente r 3 times a week. As of March 2013,there are 91 PACE programs nationally.100

Regulations for PACE organi zations at part 460, subpart s E through H, set out the minimum health and safety standards a facility must meet in order to obtain Medicare

certification. The current CoPs for PACE organizations include some requirements for emergency preparedness. We propose to remove the current PACE organization requirements at § 460.72(c)(1) through (5) and incorporate these existing requirements into proposed § 460.84, Emergency preparedness requirements for Progr ams of All-Inclusive Care for the Elderly (PACE). Existing § 460.72(c)(1), Emergency and disaster preparedness procedures, states that the PACE organization must establish, implement, a nd maintain documented procedures to manage medical and nonmedical emergencies and disasters that are likely to threaten the health or safety of the patients, staff, or the public. Existing § 460.72(c)(2) defines emer gencies to include, but not be limited to: fire; equipment, water, or power failure; care-related emergencies; and natural disasters likely to occur in the organization's geographic area. We propose incorporating the language from § 460.72(c)(1) into § 460.84(b). Existing § 460.72(c)(2), which defines the various emergenc ies, would be incorporated into § 460.84(b) as well. The statement in current § 460.72(c)(2), that "an organization is not required to develop emergency plans for natural disast ers that typically do not affect its geographic location" would not be added to the proposed rule because we are proposing that PACE organizations utilize an "all hazards" approach as proposed in § 460.84(a)(1). Existing § 460.72(c)(3), which states that "a PACE organization must provide appropriate training and periodic orientation to all staff (employees and cont ractors) and patients to ensure that staff demonstrate a knowledge of emergency procedures, incl uding informing patients what to do, where to go, and whom to contact in case of an emergency," would be incorporated into101

proposed § 460.84(d)(1). The existing requireme nts for having available emergency medical equipment, for having staff who know how to us e the equipment, and having a documented plan to obtain emergency medical assi stance from outside sources in current § 460.72(c)(4) would be relocated to proposed § 460.84(b)(9). Finally, cu rrent § 460.72(c)(5), wh ich states that the PACE organization must test the emergency and disaster plan at least annually and evaluate and

document its effectiveness would be addressed by proposed § 460.84(d)(2). The current version of § 460.72(c)(1) through (c)(5 ) would be removed. We are proposing that PACE organizations would adhere to the same requirements for emergency preparedness as hospi tals, with three exceptions. The first difference between the proposed hos pital emergency preparedness requirements and the proposed PACE emergency preparedness re quirements is that we are not proposing that PACE organizations provide basic subsistence needs for staff and patients, whether they evacuate or shelter in place, including food, wate r, and medical supplies; alternate sources of energy to maintain temperatures to protect patient health and safety and for the safe and sanitary storage of provisions; emergency lighting; and fire detection, ex tinguishing, and alarm systems; and sewage and waste disposal as we are propos ing for hospitals at § 482.15(b)(1). The second difference between the proposed hospital emer gency preparedness requirements and the proposed PACE emergency preparedness requ irements is that we propose adding at § 460.84(b)(3), a requirement for a PACE organizati on to have policies and procedures to inform state and local officials about PACE patients in n eed of evacuation from their residences at any time due to an emergency situation based on the patient's medical and ps ychiatric conditions and home environment. Such policies and procedur es must be in accord with the HIPAA Privacy102

Rule, as appropriate. This proposed requirement recognizes that many of the frail PACE patients may be unable to evacuate from their homes without assistance during an emergency. Finally, the third difference between the pr oposed requirements for hospitals and the proposed requirements for PACE organizations is that, at § 460.84(c)(7), we propose to require these organizations to have a communication plan that include a means of providing information about their needs and their ability to provide assistance to the au thority having jurisdiction or the Incident Command Center, or designee. We do not propose requiring these organizations to provide information regarding their occupanc y, as we propose for hos pitals (§ 482.15(c)(7)), since the term occupancy usually refers to bed occupancy in an inpatient facility. G. Emergency Preparedness Regulati ons for Transplant Centers (§ 482.78) Transplant centers are located within hospita ls that meet the requirements for Conditions of Participation (CoPs) in Medica re. Therefore, transplant center s must meet all hospital CoPs at § 482.1 through § 482.57. In addition, unless otherwis e specified, heart, h eart-lung, intestine, kidney, liver, lung, and pancreas centers must meet all requirements for transplant centers at § 482.72 through § 482.104. Transplant centers are respons ible for providing organ transp lantation services from the time of the potential transplant candidate's initial evaluation th rough the recipient's post-transplant follow-up care. In addition, if a center performs living donor transplants, the center is responsible for the ca re of the living donor from th e time of the initial evaluation through post-surgical follow-up care. Organs are viable for transplantation for a limited time after organ recovery. Although kidneys may remain viable for transplantation for more than 24 hours, other organs remain viable for only a few hours. Thus, according to the Organ Procurement and Transplantation103

Network (OPTN) longstanding policy, if a transplant center must tu rn down an organ for one of its patients, the organ may go to the next patient on the waiting list at another transplant center (Organ Distribution: Organ Procur ement, Distribution and Allocation, http://optn.transplant.hrsa.gov/Policies andBylaws2/policies/pdfs/policy_6.pdf ) . In such a situation, the patient on th e waiting list of the transplant center experiencing an emergency may die before an organ becomes available again. In fact, according to the OPTN, about 18 patients die every day waiting for an organ transp lant. (http://optn.transplant.hrsa.gov/) There are 770 Medicare-approved transplant cen ters. These centers provide specialized

services that are not available at all hospitals. Thus, we believe that it is crucial for every transplant center to make arra ngements with one or more ot her Medicare-approved transplant centers to provide transplantation services and ot her care to its patients during an emergency. Making such arrangements would increase the likelihood that if an organ became available for one of the transplant center's waiting list patients during an emergency, the patient would receive the transplant. Further, having such arrangements with other tr ansplant centers would increase the odds that during an emergency, a transplant center's patients would receive critically important post-transplant car e to prevent graft failure. Our regulations at § 482.68 currently require that a transplant center that has a Medicare provider agreement meet the hospital CoPs sp ecified in § 482.1 through § 482.57. Our proposed hospital CoP, "Emergency preparedness," at § 4 82.15, would apply to transplant centers. We also propose to add a new transplant center CoP at § 482.78, "Emergency preparedness". A transplant center would be required to comply with the proposed emergency preparedness hospital requirements at § 482.15, as well as th e proposed CoP for emergency preparedness for transplant centers at § 482.78. We propose at § 482.78(a) that a transp lant center have an104

agreement with at least one othe r Medicare-approved transplant ce nter to provide transplantation services and other care for its patients duri ng an emergency. Ideally, the Medicare-approved transplant center that agrees to provide care for a center's patients during an emergency would perform the same type of organ transplant as the center seeking the agreement. However, we recognize that this may not always be feasible. Under some circ umstances, a transplant center may wish to establish an agreement for the provis ion of post-transplant care and follow-up for its patients with a center that is Medicar e-approved for a different organ type. We believe a transplant center entering into an agreement for the pr ovision of services during an emergency would be in the best position to judge whethe r post-transplant care could be competently provided during an emergency by a Medicare-approved tran splant center that transplanted a different organ type. We expect that transp lant centers establishing such agreements would consider the types of services the other center had the ab ility to provide during

an emergency. We also propose at § 482.78(a) that the agreement between the transplant center and another Medicare-approved transplant center that agreed to provide care during an emergency would have to address, at a minimum: (1) the circumstances under which the agreement would be activated; and (2) the types of services that would be provided during an emergency. Currently, under the transpla nt center CoP at § 482.100, Organ procurement, a transplant center is required to ensure that the hospital in which it operates has a written agreement for the receipt of organs with the hospital's designa ted Organ Procurement Organization (OPO) that identifies specific responsibilities for the hospita l and for the OPO with re spect to organ recovery and organ allocation. We propose at § 482.78(b) to require transplant centers to ensure that the written agreement required under § 482.100 also addr esses the duties and re sponsibilities of the105

hospital and the OPO during an emergency. We have included a similar requirement for OPOs at § 486.360(c) in this proposed rule. We would expect the transplant center, the hospital in which it is located, and the designated OPO to colla borate in identifying their specific duties and responsibilities during emergency situations and include them in the agreement. We are not proposing to require transplant centers to provide basic subsistence needs for staff and patients, as we are proposing for hos pitals at § 482.15(b)(1). Also, we are not proposing to require transplant centers to se parately comply with the proposed hospital requirement at § 482.15(b)(8) rega rding alternate care sites identified by em ergency management officials. This requirement would be applicab le to inpatient provide rs since the overnight provision of care could be challenged in an emerge ncy. Transplant centers would have to meet this requirement since the transplant patient wo uld be under the care and responsibility of the hospital. H. Emergency Preparedness Requirements for Long Term Care (LTC) Facilities (§ 483.73) Section 1819(a) of the Act de fines a skilled nursing facility (SNF) for Medicare purposes as an institution or a distinct pa rt of an institution that is prim arily engaged in providing skilled nursing care and related services to patients that require medical or nursing care or rehabilitation services due to an injury, disa bility, or illness. Section 1919 (a) of the Act defines a nursing facility (NF) for Medicaid purposes as an institution or a distinct part of an institution that is primarily engaged in providing to patients: ski lled nursing care and related services for patients who require medical or nursing care; rehabilitation services due to an injury, disability, or illness; or, on a regular basis, health-rela ted care and services to individua ls who due to their mental or physical condition require care and services (abo ve the level of room and board) that are available only through an institution.106

To participate in the Medicar e and Medicaid programs, l ong-term care (LTC) facilities must meet certain requirements located at pa rt 483, Subpart B, Requirements for Long Term

Care Facilities. SNFs must be certified as meeting the requir ements of section 1819(a) through (d) of the Act. NFs must be certified as mee ting section 1919(a) through (d) of the Act. A LTC facility may be both Medicar e and Medicaid approved. LTC facilities provide a s ubstantial amount of care to Medicare and Medicaid beneficiaries, as well as "dual eligible individuals" who qualify for both Medicare and Medicaid. As of March 1, 2013, there were 15,157 LTC facilit ies and these facilities provided care for about 1.7 million patients. The current requirements for LTC facilities contain specific requirements for emergency preparedness set out at 42 CFR 483.75(m)(1) and (2). Section 483.75( m)(1) states th at a "facility must have detailed written plans and procedures to meet all pote ntial emergencies and disasters, such as fire, severe weather, and missing reside nts." We are proposing that this language be incorporated into proposed § 483.73(a)(1). Existing § 483.75(m)(2) states that a "facility must train all employees in emergency procedures when th ey begin to work in the facility, periodically review the procedures with existing staff, a nd carry out unannounced staff drills using those procedures." These requirements would be in corporated into proposed § 483.73(d)(1)and (d)(2). Sections § 483.75(m)(1) and (2) would be removed. These requirements are not sufficient to ensu re that facilities are prepared for more widespread disasters that may affect most or all of the other health care facilities in their area and that may tax the ability of local, state, and fe deral emergency management officials to provide assistance. For example, current LTC facility re quirements do not require facilities to conduct a risk assessment or to have a pl an, policies, or procedures to ensure continuity of facility107

operations during emergencies. We believe the additional requirements in this proposed rule would ensure facilities would be prepared fo r the emergencies they may face now and in the future. Thus, our proposed emergency preparedness requirements for LTC facilities are identical to those we are proposing for hospitals at § 482.15, with two exceptions. Specifically, at § 483.73(a)(1), we propose that LTC facilities wo uld establish emergency plans utilizing an "all-hazards" approach, which in an emergency situation, would include a directive to account for missing residents. In addition, long term care facilities are unl ike many of the inpatient care providers. Many of the residents can be expected to have lo ng term or extended stays in these facilities. Due to the long term nature of their stays, thes e facilities essentially become the residents' residences or homes. We believe this changes the nature of the relationship and duty to the

residents and their families or representatives. Section § 483.73( c) requires these facilities to develop an emergency prepare dness communication plan, which in cludes, among other things, a means of providing information about the genera l condition and location of residents under the facility's care. We also believe that the resi dents and their families or representatives require more information about the facility's emergenc y plan. Specifically, long term care facilities should be required to determine what information in their emergency plan is appropriate to share with its residents and their families or representa tives and that the facility have a means by which

that information is disseminated to those indivi duals. The facility should also determine the appropriate time for that information to be diss eminated. We are not i ndicating what information from the emergency plan should be shared or the timing or manner in which it should be

disseminated. We believe that each facility should have the flexibility to determine the information that is most appropriate to be sh ared with its residents and their families or108

representatives and the most efficient manner in wh ich to share that inform ation. Therefore, we propose to add an additional requirement at § 483.73(c)(8) that reads, "A method for sharing information from the emergency plan that the facility has determined is appropriate with

residents and their families or representatives." Also, as discussed in section II.A.4 of the preamble we are proposing at §483.73(e)(1)(i) that LTC facilities must store emergency fuel an d associated equipment and systems as required by the 2000 edition of the Life Safety Code (LSC ) of the National Fire Protection Association (NFPA). In addition to the emergency power system inspection and testing requirements found in NFPA 99 and NFPA 110 and NFPA 101, we propos e that LTC facilities test their emergency and stand-by-power systems for a minimum of 4 continuous hours every 12 months at 100 percent of the power load the LTC facility an ticipates it will require during an emergency. In addition to the emergency energy requirement s discussed earlier, we also believe that

LTC facilities should consider th eir individual residents’ power needs. For example, some

residents could have motorized wheelchairs that they need for mobility or require a continuous positive airway pressure or CPAP machine due to sleep apnea. In §483.73(a)(1) and (3), we propose that the LTC facility address, among othe r things, its resident population and continuity of operations in its emergency plan. The LTC fa cility must also base its emergency plan on a risk assessment, utilizing an all-hazards approach. We believe that the currently proposed requirements encompass consideration of indivi dual residents’ power needs and should be

included in LTC facilities’ risk assessments a nd emergency plans. However, we are also soliciting comments on whether there should be a specific requirement for “residents’ power needs” in the LTC requirements.109

I. Emergency Preparedness Regulations for Inte rmediate Care Facilities for Individuals with

Intellectual Disabiliti es (ICFs/IID) (§ 483.475) Section 1905(d) of the Act crea ted the ICF/IID benefit to fund "institutions" with four or more beds to serve people with [intellectual disa bility] or other related conditions. To qualify for Medicaid reimbursement, ICFs/IID must be certified and comply with CoPs at 42 CFR part 483, Subpart I, § 483.400 through § 483.480. As of Marc h 2013, there were 6,442 ICFs/IID, serving approximately 129,000 patients, and all patient s receiving ICF/IID services must qualify financially for Medicaid assistance. Patients with intellectual disabi lities who receive care provided by ICFs/IID may have additional emerge ncy planning and preparedness requirements. For example, some care recipients are non-ambulat ory, or may experience additional mobility or sensory disabilities or impairment s, seizure disorders, behavioral challenges, or mental health challenges. Some ICFs/IID are small and serve only a few patients. However, we do not believe

small ICFs/IID or ICFs/IID in general would have difficulty mee ting the proposed requirements. In fact, small facilities might find it easier than large facilities to develop an emergency preparedness plan and emergency preparedness po licies and procedures. As an example, an ICF/IID with only four patients is likely to have a sufficient number of its own vehicles available during an emergency to evacuate patients and staff, eliminating the need to contract with an outside entity to provide tr ansportation during an emerge ncy situation or disaster. Because ICFs/IID vary widely in size and th e services they provide, we expect that the risk analyses, emergency plans, emergency pol icies and procedures, emergency communication plans, and emergency preparedness training will vary widely as well. Nevertheless, we believe110

each of them has the capability to comply fully with the requir ements so that the health and safety of its patients are protected in the ev ent of an emergency situation or disaster. Thus, we propose requiring that ICFs/IID m eet the same requirements we are proposing for hospitals, with two exceptions. At § 483.475(a )(1), we propose that IC Fs/IID utilize an all hazards approach, including consideration for missing clients. We believe th at in the event of a natural or man-made disaster, ICFs/IID would mainta in responsibility fo r care of their own patient population but would not receive patient s from the community. Also, because we recognize that all ICFs/IID patients have spec ial needs, we propose requiring ICFs/IID to "address the special needs of its clie nt population ..." at § 483.475(a)(3). In addressing the special needs of its clie nt population, we believe that ICFs/IID should

consider their individual reside nts’ power needs. For exampl e, some residents could have motorized wheelchairs that they need for m obility or require a c ontinuous positive airway pressure or CPAP machine due to sleep apn ea. We believe that the currently proposed requirements at §483.475(a)(a risk assessment utili zing an all-hazards approach and that the facility address the special needs of its client population) encomp ass consideration of individual residents’ power needs and should be included in ICFs/IID’s risk assessments and emergency plans. However, we are also soliciting co mments on whether there should be a specific requirement for “residents’ power needs” in the ICFs/IID CoPs. As we stated earlier, the purpos e of this proposed rule is to establish requirements to ensure that Medicare/Medicaid pr oviders and suppliers are prepar ed to protect the health and safety of patients in their car e during more widespread local, st ate, and national emergencies. We do not believe the existing requirements fo r ICFs/IID are sufficiently comprehensive to protect patients during an emerge ncy that impacts the larger co mmunity. For example, they do111

not require facilities to plan for sheltering in pl ace. However, in developing this proposed rule, we have been careful not to remove emergency preparedness requirements that are more rigorous than those we are proposing. The current regulations for ICFs/IID include requirements for emergency preparedness. Specifically, § 483.430(c)(2) and (c)(3 ) contain specific requirements to ensure that direct care givers are available at all times to respond to illness, injury, fire, a nd other emergencies. However, we do not propose to relocate thes e existing facility staffing requirements at § 483.430(c)(2) and § 483.430(c)(3) because they addr ess staffing issues based on the number of patients per building and patient be haviors, such as aggression. Such requirements, while related to emergency preparedness tangentially, are not within the scope of our proposed emergency preparedness requirements for ICFs/IID. Current § 483.470, Physical environment, in cludes a standard for emergency plan and procedures at § 483.470(h) and a standard for evac uation drills at § 483.470(i). The standard for emergency plan and procedures at current § 483.470(h)(1) requires facil ities to develop and implement detailed written plans and procedures to meet all potential emergencies and disasters, such as fire, severe weather, and missing client s. This requirement would be relocated to proposed § 483.475(a)(1). Existing § 483.470(h)(1) would be removed. Currently § 483.470(h)(2) states, with regard to a facility's emergency plan, that the facility must communicate, periodically review th e plan, make the plan available, and provide training to the staff. These requirements are covered in proposed § 483.475(d). Current § 483.470(h)(2) would be removed. ICFs/IID are unlike many of the inpatient car e providers. Many of the clients can be expected to have long term or ex tended stays in these facilities. Due to the long term nature of112

their stays, these facilities essent ially become the clients' residences or homes. We believe this changes the nature of the relations hip and duty to the clients and thei r families or representatives. Section 483.475(c) requires th ese facilities to develop an emergency preparedness communication plan, which includes, among othe r things, a means of providing information about the general condition and loca tion of clients under the facility's care. We also believe that

the clients and their families or representatives require more in formation about the facility's emergency plan. Specifically, ICFs/IID should be required to determine what information in their emergency plan is appropriate to share with its clients and th eir families or representatives and that facilities have a means by which that in formation is disseminated to those individuals. The facility should also determin e the appropriate time for that information to be disseminated. We are not indicating what information from the emergency plan should be shared or the timing or manner in which it should be disseminated. We believe that each facility should have the flexibility to determine the information that is mo st appropriate to be shar ed with its clients and their families or representatives and the most effi cient manner in which to share that information. Therefore, we propose to add an additional requi rement at § 483.475(c)(8) that reads, "A method for sharing information from the emergency plan th at the facility has determined is appropriate with clients and their families or representatives."

The standard for disaster drills set forth at existing § 483.470(i)(1) spec ifies that facilities must hold evacuation drills at least quarterly fo r each shift of personnel under varied conditions to ensure that all personnel on all shifts are tr ained to perform assigned tasks; ensure that all personnel on all shifts are familiar with the use of the facility's fire protection features; and

evaluate the effectiveness of their emer gency and disaster plans and procedures.113

Currently § 483.470(i)(2) further spec ifies that facilities must ev acuate patients during at least one drill each year on each shift; make special provisions for the evacu ation of patients with physical disabilities; file a re port and evaluation on each evacuati on drill; and investigate all problems with evacuation drills, including accidents, and take corre ctive action. Further, during fire drills, facilities may evacu ate patients to a safe area in facilities certified under the Health Care Occupancies Chapter of the Life Safety C ode. Finally, at existing § 483.470(i)(3), facilities must meet the requirements of paragraphs § 483.470( i)(1) and (2) for any live-in and relief staff they utilize. Because these existing requirements are so extensive, we propose cross referencing § 483.470(i) (redesignated as § 483.470(h)) at proposed § 483.475(d). J. Emergency Preparedness Regulations fo r Home Health Agencies (HHAs) (§ 484.22) Under the authority of sections 1861(m), 1861( o), and 1891 of the Act, the Secretary has established in regulations the re quirements that a home health agency (HHA) must meet to participate in the Medicare program. Home h ealth services are covere d for qualifying elderly and people with disabilities w ho are beneficiaries under the Hospital Insurance (Part A) and Supplemental Medical Insurance (Part B) benef its of the Medicare program. These services include skilled nursing care, physi cal, occupational, and speech ther apy, medical social work and

home health aide services which must be fu rnished by, or under arrangement with, an HHA that participates in the Medicare program and mu st be provided in the beneficiary's home. As of March 1, 2013, there were 12,349 HHAs pa rticipating in the Medicare program. The majority of HHAs are for-profit, privately owned agencies. The effective delivery of quality

home health services is essential to the care of illnesses and preventi on of hospitalizations. With so many patients depending on the servi ces of HHAs nationwide, it is imperative that HHAs have processes in pla ce to address the safety of pati ents and staff and the continued114

provision of services in the even t of a disaster or emergency. However, there are no existing emergency preparedness requirements c ontained under the HHA Medicare regulations at part 484, Subparts B and C. Thus, we propose to add emergency preparedness requirements at § 484.22, pursuant to which HHAs would be required to comply with some of the requirements that we propose to require for hospitals. We are proposing addi tional requirements under the HHA policies and procedures that would apply to HHAs but not to hospitals to address the unique circumstances under which HHAs provide services. First, because HHAs provide health care in patients' homes, we propose at § 484.22(b)(1) that an HHA have policies and procedures that in clude plans for its patients during a natural or man-made disaster. We propose that the HHA in clude individual emergency preparedness plans for each patient as part of the compre hensive patient assessment at § 484.55. Second, because we learned from the expe rience of Hurricane Katrina that many medically compromised people were unable to es cape their homes to seek safe shelter, at § 484.22(b)(2), we propose requiring an HHA to have policies and procedures to inform state and local emergency preparedness officials about HHA patients in ne ed of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment. Su ch policies and procedures must be in accord with the HIPAA Privacy Regulations, as appr opriate. Although we do not propose how such notification would take place, we expect that maintaining an accura te list of HHA patients would be necessary. However, we believe the potenti al need for assistance with such factors as transportation or evacuation, for example, c ould be addressed as an ongoing process of evaluating the patient's medical and psychi atric condition and home environment.115

We are not proposing to require that HHAs meet all of the sa me requirements that we are proposing for hospitals. Since HHAs provide health care services on ly in patients' homes, we are not including proposed requirement s for policies and procedures fo r the provision of subsistence needs (§ 482.15(b)(1)); safe evacuation (§ 482.15( b)(3)); and a means to shelter in place (§ 482.15(b)(4)). We would not expect an HHA to be responsible for sheltering HHA patients in their homes or sheltering staff at an HHA main or branch offices . We do not propose to require that HHAs comply with the proposed hospita l requirement at § 482.15(b)(8) regarding the provision of care and treatment at alternate care sites identif ied by emergency management officials. This proposed requirement would be applicable only to inpatient providers. With respect to communication, we have not include d proposed requirements for HHAs to have a means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510 as we are proposing for hospitals at § 482.15(c)(5). We have also modified the proposed requirement for hospitals at § 482.15(c )(7) by eliminating the reference to providing information regarding the facility's occupancy. The term occupancy usually refers to bed occupancy in an inpatient facility. Instead, at § 484.22(c)(6), we would require HHAs to provide

information about the HHA's needs and its abilit y to provide assistance to the authority having jurisdiction or the Incident Command Ce nter, or designee. In developing its policies and procedures, we would expect an HHA to consider whether it would accept new referrals dur ing a disaster or emergency s ituation, and how it would care for new patients. We also would urge HHAs to in clude a method for providing information to all new patients and their families about the role th e HHA would play in the event of an emergency. Overall, our expectation for HHAs is that they would work closely with other HHAs and with the hospitals in their referral areas to plan for disasters and emergency situations.116

K. Emergency Preparedness Regulations for Comp rehensive Outpatient Re habilitation Facilities (CORFs) (§ 485.68) Section 1861(cc) of the Act defines the term "comprehensive outpatient rehabilitation facility" (CORF) and lists the requirements that a CORF must meet to be eligible for Medicare participation. By definition, a CO RF is a non-residential facility that is established and operated exclusively for the purpose of providing diagnostic, therapeutic, and restorative services to outpatients for the rehabilitation of injured, sick, and persons with disabili ties, at a single fixed location, by or under the superv ision of a physician. As of March 2013, there were 272

Medicare-certified CORFs in the U.S. Section 1861(cc)(2)(J) of the Act also states that the CORF must meet other requirements that the Secretary finds necessary in the interest of the health and safety of a CORF's patients. Under this authority, the Secretary has establ ished in regulations, at part 485, Subpart B, requirements that a CORF must meet to participate in the Medicare program. Currently § 485.64 "Conditions of Participa tion: Disaster procedures " includes emergency preparedness requirements CORFs must meet. The regulations state that the CORF must have written policies and procedures that specifically define the handling of patients, personnel, records, and the public during disasters. The regulati on requires that all personnel be knowledgeable with respect to thes e procedures, be trained in th eir application, and be assigned specific responsibilities. Currently § 485.64(a) requires a CORF to have a written disaster plan that is developed and maintained with the assistance of qualified fi re, safety, and other appropriate experts. The other elements under § 485.64(a) require that CORFs have: (1) proced ures for prompt transfer of casualties and records; (2) pr ocedures for notifying community emergency personnel; (3)117

instructions regarding the location and use of alarm syst ems and signals and firefighting equipment; and (4) specification of evacuation routes and procedures for l eaving the facility. Currently § 485.64(b) requires e ach CORF to: (1) provide ongoing training and drills for all personnel associated with the CO RF in all aspects of disaster preparedness; and (2) orient and assign specific responsibilities rega rding the facility's disaster plan to all new personnel within 2 weeks of their first workday. Although these requirements are important, th ey do not address the coordination across providers and suppliers and acro ss the various federal, state, and local emergency response systems necessary to ensure the health and sa fety of CORF patients during an emergency. Despite CORFs being non-residential treatment facilities, we believe they should comply with the same requirements that would be required for hospitals, with appropriate exceptions. At § 485.68(a)(5), we propose that CORFs develop and maintain the emergency preparedness plan with assistance from fire, sa fety, and other appropriate experts. We do not propose to require CORFs to provi de basic subsistence needs for staff and patients as we are proposing for hospitals at § 482.15(b)(1). Because CORFs are outpatient facilities, we are not proposing that CORFs have a system to track the location of staff and patients under the CORF's care both during and after the emer gency as we propose to require fo r hospitals at § 482.15(b)(2). At § 482.15(b)(3), we propose that hospitals have policies and procedures for safe evacuation from the hospital, which would includ e 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 sour ces of assistance. We do not believe all of these requirements are appropr iate for CORFs, which serve only outpatients. Therefore, at § 485.68(b)(1), we are proposing to require that CORF s have policies and118

procedures for evacuation from the CORF, incl uding staff responsibilities and needs of the patients. Because CORFs are outpatient facilities that provi de specific, limited services to patients, we are not proposing that CORFS have arrangements with other CORFs or other providers to receive patients in the event of limitations or cessation of operations. Finally, we do not propose to require CORFs to comply with the proposed hospital requirement at § 482.15(b)(8) regarding alternate care sites identified by emergency management officials. With respect to communication, we would not require CORFs to comply with the proposed requirement for hospitals at § 482.15(c)(5 ) that would require a hospital to have a means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510. In addition, CORFs would not be required to comply with the proposed requirement at § 482.15(c)(6), which would state th at a hospital must have a means of providing information about the general condition a nd location of patients as permitted under 45 CFR 164.510(b)(4). We propose including in the CORF emergenc y preparedness provisions a requirement for CORFs to have a method for sharing information and medical documentation for patients under

the CORF's care with other health care providers, as necessary, to ensure continuity of care (see proposed § 485.68(c)(4)). However, we would e xpect CORFs to implement this requirement only for patients receiving care at the facility at the time of the disaster or emergency situation. Given that CORFs are primarily providers of a limited range of outpatient services, we do not expect a CORF to know the whereabouts of its pa tients who are living in the community, as we would expect of hospices, HHAs, an d PACE facilities. An add itional modification from what has been proposed for hospitals at § 482.15(c )(7), at § 485.68(c)(5), we propose to require119

CORFs to have a communication plan that includ e a means of providing information about the CORF's needs and its ability to provide assistan ce to the authority having jurisdiction or the Incident Command Center, or designee. We do not propose requiring CORFs to provide information regarding their occupancy, as we pr opose for hospitals, sin ce the term occupancy usually refers to bed occupanc y in an inpatient facility. Our goal is to ensure that we incorpor ate existing CORF disaster preparedness requirements into our proposed emergency prepar edness rule. Although we believe the current CORF disaster preparedness requ irements are largely reflected in the language we propose for other providers and suppliers, there are specific instances in which the existing CORF requirements are more stringent, such as the requ irement to assign specific disaster preparedness tasks to new personnel within two weeks of their first work day. This existing requirement at § 485.64(b)(2) would be relocate d to proposed § 485.68(d)(1). Currently § 485.64 requires a CORF to develop and maintain its disaster plan with assistance from fire, safety, and other appropriate experts. We have incorporated this requirement at proposed § 485.68(a)(5). Currently § 485.64(a)(3) would requi re that the training program include instruction in the location and us e of alarm systems and signals and firefighting equipment. We have incorporated these requ irements at proposed § 485.68(d)(1). We propose to remove current § 485.64. L. Emergency Preparedness Regulations fo r Critical Access Hospitals (CAHs) (§ 485.625 ) Sections 1820 and 1861(mm) of the Act pr ovide that critical access hospitals participating in Medicare and Medicaid meet certain specified requirements. We have implemented these provisions in 42 CFR part 485, Subpart F, Conditions of Participation for Critical Access Hospitals (CAHs ). As of March 1, 2013, there are 1,332 CAHs that must meet120

the CAH CoPs and 95 CAHs with ps ychiatric or rehabilitation dis tinct part units (DPUs) that must meet the hospital CoPs in order to receiv e payment for services provided to Medicare or Medicaid patients in the DPU. CAHs are small, generally rural, limited-serv ice facilities with low patient volume. The intent of designating facilities as "critical access hospitals" is to preserve access to primary care and emergency services that meet community needs. A CAH is not required to be sta ffed if there are no inpatients in the facility. However, in the event of an emergency, existing requirements st ate there must be a doctor of medicine or osteopathy, a physician assistant, a nurse practitioner, or a clinical nurse specialist, with training or experience in emergency care, on call and im mediately available by te lephone or radio contact

and available onsite within 30 mi nutes on a 24-hour basis or, under certain circumstances, within 60 minutes. CAHs currently are required to coor dinate with emergency response systems in the area to provide 24-hour emergency coverage. We believe the existing requirements provide only a limited framework for protecting th e health and safety of CAH pa tients in the event of a major disaster. They do not include the requirements we propose that we believe will ensure a well-coordinated emergency preparedness system of care. CAHs are required at existing § 485.623(c), "Standard: Emergency procedures," to assure the safety of patients in non-medica l emergencies by training staff in handling emergencies, including prompt reporting of fires; extinguishing of fires; protection and, where necessary, evacuation of patients, personnel, an d guests; and cooperation with firefighting and

disaster authorities. CAHs must provide for emergency power and lighting in the emergency room and for battery lamps and fl ashlights in other areas; provid e for fuel and water supply; and take other appropriate measures th at are consistent with the partic ular conditions of the area in121

which the CAH is located. Since CAHs are requir ed to provide emergency services on a 24-hour a day basis, they must keep equipment, supplie s, and medication used to treat emergency cases readily available. We propose to remove the current standa rd at § 485.623(c) and relocate these requirements into the appropriate sections of a new CoP entitled, "Condition of Participation: Emergency Preparedness" at § 485.625, which woul d include the same requirements that we propose for hospitals. Since CAHs function as acute care providers in rural and remote communities, we believe that they should be prepared in the event of a disast er to provide critical

care to individuals in their communities. Althou gh CAHs are much smaller than most Medicareand Medicaid-participating hospitals , we do not expect them to have difficulty meeting the same requirements we propose for hospitals. CAHs can draw upon a large number of resources at the federal, state, and local level for a ssistance in meeting the requirements. We propose to relocate current § 485.623(c)(1 ) to proposed § 485.625(d)(1). We propose to incorporate current § 485.623(c)(2) into § 48 5.625(b)(1). Current § 485.623(c)(3) would be included in proposed § 485.625(b)(1). Current § 485.623(c)(4) would be reflected by the use of the term "all-hazards" in pr oposed § 485.625(a)(1). Section 485.623( d) would be redesignated as § 485.623 (c). Also, as discussed in section II.A.4 of the preamble we are proposing at § 485.625(e)(1)(i) that CAHs must store emergenc y fuel and associated equipment and systems as required by the 2000 edition of the Life Safety Code (LSC) of the National Fire Protection Association (NFPA). In addition to the em ergency power system inspection and testing requirements found in NFPA 99 and NFPA 110 and NFPA 101, we propose that CAHs test their122

emergency and stand-by-power sy stems for a minimum of 4 con tinuous hours every 12 months at 100 percent of the power load the CAH anticip ates it will require dur ing an emergency. M. Emergency Preparedness Regulation for Clinic s, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (§ 485.727) Under the authority of section 1861(p) of the Ac t, the Secretary has established CoPs that clinics, rehabilitation agencies , and public health agencies mu st meet when they provide outpatient physical therapy (OPT) and speech-lan guage pathology (SLP) services. Under section 1861(p) of the Act, the Secretary is responsible for ensuring that the CoPs and their enforcement are adequate to protect the health and safety of individuals rece iving OPT and SLP services from

these entities. The CoPs are se t forth at part 485, Subpart H. Section 1861(p) of the Act describes "outpa tient physical therapy services" to mean physical therapy services furnished by a provider of services, a clinic, reha bilitation agency, or a public health agency, or by others under an arra ngement with, and under the supervision of, such provider, clinic, rehabilita tion agency, or public hea lth agency to an individual as an outpatient. The patient must be under the care of a physician. The term "outpatient physical therapy serv ices" also includes physical therapy services furnished to an individual by a physical therapist (i n the physical therapist's office or the patient's home) who meets licensing and other standards pres cribed by the Secretar y in regulations, other than under arrangement with and under the supe rvision of a provider of services, clinic, rehabilitation agency, or public health agency, if the furnishing of such services meets such conditions relating to health and safety as th e Secretary may find necessary. The term also123

includes SLP services furnished by a provider of se rvices, a clinic, rehabi litation agency, or by a public health agency, or by ot hers under an arrangement. As of March 1, 2013, there are 2,256 clinics, re habilitation agencies , and public health agencies that provide outpatient physical thera py and speech-language pathology services. In the remainder of this proposed rule and thr oughout the requirements, we use the term "organizations" instead of "clin ics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services" for consistency with current regulatory language. Most of these providers are small facilities operated by a group of three or more physicians , as required at § 485.703 under the definition of "clinic", practicing medicine together, as well as various other rehabilitation professionals. At § 485.727(b)(1), we are propos ing to require that organi zations have policies and procedures for evacuation from the organization, including staff responsib ilities and needs of the patients. We believe these organizations comply w ith a provision similar to our proposed requirement for hospitals at § 482.15(c)(7) which st ates that a communication plan must include a means of providing information about the hosp ital’s occupancy, needs, and its ability to provide assistance, to the au thority having jurisdiction, the Incident Command Center, or designee. At § 485.727(c)(5), we propose to re quire that these organizations to have a communication plan that include a means of pr oviding information about their needs and their ability to provide assistance to the authority havi ng jurisdiction (local and state agencies) or the Incident Command Center, or designee. We do not propose to require th ese organizations to provide information regarding their occupancy, as we proposed for hospitals, since the term "occupancy" usually refers to bed o ccupancy in an inpatient facility.124

The current regulations at § 485.727, "Disaste r preparedness," require these organization to have a disaster plan. The pl an must be periodically rehearsed, with procedures to be followed

in the event of an internal or external disa ster and for the care of casualties (patients and personnel) arising from a disaster. Additionally , current § 485.727(a) requires that the facility have a plan in operation with procedures to be followed in the event of fire, explosion, or other disaster. We believe these requirements are a ddressed throughout the proposed CoP, and we do not propose including the specific language in our proposed rule. However, existing § 485.727(a) also requires th at the plan be deve loped and maintained with the assistance of qualified fi re, safety, and other appropriate experts. Because this existing requirement is specific to existing disaster prep aredness requirements for these organizations, we have relocated the language to proposed § 485.727(a)(6). Existing requirements at § 485.727(a) also state that the disaster plan must include: (1)

transfer of casualties and record s; (2) the location a nd use of alarm systems and signals; (3) methods of containing fire; (4) not ification of appropria te persons, and (5) evacuation routes and procedures. Because transfer of casualties and records, notification of appropriate persons, and evacuation routes are addressed under policies a nd procedures in our proposed language, we do not propose to relocate these requirements. Howe ver, because the requirements for location and use of alarm systems and signals and methods of containing fire ar e specific for these organizations, we propose relocating th ese requirements to § 485.727(a)(4). Currently § 485.727(b) specifies requirements for staff training and drills. This requirement states that all employees must be tr ained, as part of their employment orientation, in all aspects of preparedness for any disaster. This disaster program must include orientation and ongoing training and drills for all personnel in all procedures so that each employee promptly125

and correctly carries out his or her assigned role in case of a disaster. Because these requirements are addressed in proposed § 485.727(d) , we do not propose to relocate them but merely to address them in that paragraph. Current § 485.727, "Disaster preparedness," would be

removed. N. Emergency Preparedness Regulations for Community Mental Health Centers (CMHCs) (§ 485.920) A Community Mental Health Center (CMHC) as defined in section 1861(ff)(3)(B) of the Act, is an entity that meets applicable licensing or certification requirements in the state in which it is located and provides the set of services spec ified in section 1913(c)(1) of the Public Health

Service Act. Section 4162 of Pub. L. 101-508 (OBRA 1990), which amended section 1861(ff)(3)(A) and 1832(a)(2)(J) of th e Act, includes CMHCs as entiti es that are authorized to provide partial hospitali zation services under Part B of the Medicare program, effective for services provided on or after October 1, 1991. Section 1866(e)(2) of the Act and 42 CFR part 489.2(c)(2) recognize CMHCs as provide rs of services for purposes of provider agreement requirements but only with respect to providing partial hospitali zation services. In

2010 there were 207 Medicare-certified CM HCs serving approximately 27,738 Medicare

beneficiaries. Pursuant to 42 CFR 410.2 and 410.110, a CMHC may receive Medicare payment for partial hospitalization services only if it demonstrates that it provides the following core services:

• Outpatient services, incl uding specialized outpatient serv ices for children, the elderly, individuals who are chronically me ntally ill, and residents of th e CMHC's service area who have been discharged from inpatient trea tment at a mental health facility.

• 24 hour-a-day emergency care services.126

• Day treatment, or other pa rtial hospitalization services, or psychosocial rehabilitation

services.

• Screening for clients being considered for admission to state mental health facilities to determine the appropriateness of such admission. However, effective March 1, 2001, the Medicare, Medicaid, and State Ch ildren's Health Insurance Program Benefits Improvement and Protection Act of 2000 allows CMHCs to provide these services by c ontract if state law precludes the entity from provi ding the screening services.

• Meets applicable licensing or certification requirements for CMHCs in the state in

which it is located.

• Provides at least 40 percent of its services to individua ls who are not eligible for

benefits under Title XVIII of the Act. To qualify for Medicare reimbursement, CMHC s must comply with requirements for coverage of partial hospitalizat ion services at § 410.110 and condi tions for Medicare payment of partial hospitalization services at § 424.24(e). We will soon finalize the first health and safety CoPs for CMHCs, and while CMS is cognizant of the overall burden, we be lieve it is appropriate to also require CMHCs to meet the same em ergency preparedness requirements as other outpatient facilities. Consistent with our proposed requirements for other Medicare and Medicaid participating providers and suppliers , we would require that CMHCs comply with emergency preparedness requirements to ensure a well-coordinated emer gency response in the event of a disaster or emergency situation. We are proposing that CMHCs meet the same emergency preparedness requirements we prop ose for hospitals, with a few exceptions. Since CMHCs are outpatient facilities, we would expect that in an emergency, the CMHC would instruct clients and staff not to report to the facility. In th e event that clients and127

staff were in the facility when a disaster or emergency situation occurr ed, we would expect the CMHC to encourage clients and staff to leave the f acility to seek safe shelter in the community. We would expect most clients and staff to return to their homes. Additionally, at § 485.920(c)(7 ), we propose to require these CMHCs to have a communication plan that include a means of pr oviding information about the CMHCs needs and its ability to provide assistance to the author ity having jurisdiction or the Incident Command Center, or designee. Some CMHCs are small facilities with just a few clients and may be located in rural areas. These CMHCs could find it challenging to develop a well-coordinated emergency preparedness plan. However, we believe even small CMHCs would be able to develop an appropriate emergency preparedne ss plan with the assistance of federal, state, and local community resources. O. Emergency Preparedness Regulations fo r Organ Procurement Organizations (OPOs) (§ 486.360) Section 1138(b) of the Act and 42 CFR part 486, subpart G establish that OPOs must be certified by the Secretary as meeting the requi rements to be an OPO and designated by the Secretary for a specific Donati on Service Area (DSA). The current OPO CfCs do not contain any emergency preparedness requirements. There are currently 58 Medicare certified OPOs that are responsible for identifying potential organ donors in hospitals, assessing th eir suitability for dona tion, obtaining consent from next-of-kin, managing potential donors to ma intain organ viability, coordinating recovery of organs, and arranging for transport of organs to transplant centers. If an emergency affects an128

OPO's ability to provide its services, organ proc urement services to its entire DSA may be

affected. Our proposed requirements for OPOs to develop and maintain an emergency preparedness plan, are similar to those proposed for hospitals, with some exceptions. Since potential donors generally are lo cated within hospitals, at proposed § 486.360(a)(3), instead of addressing the pati ent population as proposed for hospitals at § 482.15(a)(3), we propose that the OPO address th e type of hospitals w ith which the OPO has agreements; the type of services the OPO has the capacity to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. That is, we would expect an OPO to consider the type of hospitals it serves when it develops its emergency plan, for example, a large hospital with a trauma center located in a major metropolitan area or a small rural hospital lacking an operating room. Because the services provided by OPOs are so different from the services provided by a hospital and because potential donors generally are located within hospitals, we propose only two requirements for OPOs at § 486.360(b): (1) a sy stem to track the loca tion of staff during and after an emergency; and (2) a system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and ensures records are secure and readily available. Since OPOs' potential donors ge nerally are located within hospitals and since OPOs do not have physical structures in which to house patients, OPOs would not be expected to have policies and procedures to addr ess the provision of subsistence needs for staff and patients. Instead, we believe these responsibil ities would rest upon the hospital.129

In addition, at § 486.360(c), we are proposi ng only three requirements for an OPO's communication plan. An OPO's communication pl an would include: (1) names and contact information for staff; entities providing serv ices under arrangement; volunteers; other OPOs; and transplant and donor hospitals in the OPO's DSA; (2) contact information for federal, state, tribal, regional, or local emerge ncy preparedness staff and other sources of assistance; and (3) primary and alternate means for communicating with the OPO's staff, federal, state, tribal, regional, or local emergency management ag encies. We believe the additional proposed requirements regarding communicati on would specifically be a hospi tal's responsibility in caring for its patient population. Unlike the requirement we have proposed fo r hospitals at § 482.15(d)(2)(i) and (iii), which would be required to conduct both a mock disaster drill and a tabletop exercise, we propose at § 486.360(d)(2)(i) that an OPO would be re quired only to conduct a tabletop exercise. Since the OPO's patients reside in the hospital, we expect the OPO to show due consideration for its emergency response efforts by engaging in su ch a tabletop exercise. However, the OPO typically does not have physical pos session of patients to fully engage in a mock disaster drill as proposed for hospitals. Since an OPO does not deal directly with patients, a mock disaster drill would be unnecessary. Finally, at § 486.360(e), we propos e that each OPO have agreement(s) with one or more other OPOs to provide essential organ procuremen t services to all or a portion of the OPO's DSA in the event that the OPO cannot provide such se rvices due to an emergency. We also propose that the OPO include within its agreements w ith hospitals required under § 486.322(a) and in the protocols with transplant programs required under § 486.344(d), the duties and responsibilities of the hospital, transplant program, and th e OPO in the event of an emergency.130

P. Emergency Preparedness Regulations for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (§ 491.12) Section 1861(aa) sets forth the Rural Health C linic and Federally Qualified Health Center services covered by the Medicare and Medicaid program. "RHCs" must be located in an area

that is both rural and underserved.

Conditions for Certification for RHCs and Conditions of Coverage for FQHCs are found at 42 CFR part 491, Subpart A. Current emer gency preparedness requirements are found at § 491.6. Currently, an RHC is staffed with personne l that are required to provide medical emergency procedures as a first response to comm on life threatening injuri es and acute illnesses and to have available the drugs and biologicals commonly used in life-saving procedures. The definition of a "first response" is a service that is commonly provided in a physician's office. FQHCs are required to provide emergency care either on site or through clearly defined arrangements for access to health care for me dical emergencies during and after the FQHC's regularly scheduled hours. Therefore, FQHCs mu st provide for access to emergency care at all

times. Clinics and centers ha ve varying hours and days of operation based on staff and anticipated patient load.

We are aware of the difficulties that rural communities have attracting and retaining a variety of professionals, includi ng health care professionals. Ho wever, there is a present and growing need for all providers and suppliers to develop plans to care for their staff and patients during a disaster. We propose that the RHCs' and FQHCs' emergency preparedness plans must address the type of services the facility has the capacity to prov ide in an emergency. We expect that they would evaluate thei r ability to provide services based on, but not limited to, the131

facility's size, available human and material resources, geographic lo cation, and ability to coordinate with community resources. Thus, wh ile Medicare providers or suppliers in a large metropolitan community may be better able to prov ide the majority of its services during an emergency event, rural, providers and suppliers, especially those in frontier areas, may find it far more challenging to provide simila r services during an emergency. We believe many RHCs and FQHCs would be able to develop a comprehensive emergency plan that addresses "all-hazards" pol icies and procedures, a communication plan, and training and testing by drawing upon a variety of res ources that can provide technical assistance. For example, HRSA's Office of Rural Health Policy (ORHP), guide entitled, "Rural Health Communities and Emergency Preparedness," that is available on HRSA's website at: ftp://ftp.hrsa.gov/ruralhea lth/RuralPreparedness.pdf is a good source. Although RHCs and FQHCs currently do not ha ve specific requirements for emergency preparedness, they have requirements for "E mergency Procedures" found at § 491.6, under "Physical plant and environment." At § 491.6(c )(1), the RHC or FQHC must train staff in handling non-medical emergencies. This re quirement would be addressed at proposed § 491.12(d)(1). At § 491.6(c)(2), the RHC or FQ HC must place exit signs in appropriate locations. This requirement would be inco rporated into our proposed requirement at § 491.12(b)(1), which would require RHCs and FQHCs to have policies and procedures for safe evacuation from the facility which includes appropriate placement of exit signs. Finally, at § 491.6(c)(3), the RHC or FQHC must take other appropriate measur es that are consistent with the particular conditions of the area in which the facility is located. Th is requirement would be addressed throughout the proposed CoP for RH Cs and FQHCs, particularly proposed132

§ 491.12(a)(1), which requires the RHCs and FQHC s to perform a risk assessment based on an "all-hazards" approach. Current § 491.6(c) would be removed. We are proposing emergency preparedness re quirements based on the requirements that we are proposing for hospitals, modified to a ddress the specific characteristics of RHCs and FQHCs. We do not propose to re quire RHC/FQHCs to provide basi c subsistence needs for staff and patients. Also, unlike that proposed for hos pitals at § 482.15(b)(2), we are not proposing that RHCs/FQHCs have a system to track the locati on of staff and patients in the facility's care both during and after the emergency. At § 482.15(b)(3), we propose that hospitals have policies and procedures for safe evacuation from the hospital, which includes co nsideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sour ces of assistance. We do not believe all of these requirements are appropriate for RHCs/FQHCs, which serve only outpatients. Therefore, at § 491.12(b)(1), we are proposing to require that RHCs/FQHCs have policies and procedures for evacuation from the RHC/FQHC, including appropria te placement of exit signs, staff responsibilities, and needs of the patients. Unlike the requirement that is being proposed for hospitals at § 482.15(b)(7), we are not proposing that RHCs/FQHCs have arrangements w ith other RHCs/FQHCs or other providers to receive patients in the event of limitations or ces sation of operations to ensure the continuity of services to RHC/FQHC patients. We do not propose to require RHC/FQHCs to comply with the proposed hospital requirement at § 482.15(b)(8) regarding a lternate care sites. In addition, we would not require RHCs /FQHCs to comply with the proposed requirement for hospitals found at § 482.15(c)(5), which would require that a hospital have a133

means, in the event of an evacuation, to release patient information as permitted under

45 CFR 164.510. Modified from wh at has been proposed for hos pitals at § 482.15(c)(7), at § 491.12(c)(5), we propose to require RHCs/FCHCs to have a communication plan that would include a means of providing information abou t the RHCs/FQHCs needs and their ability to provide assistance to the authority having juri sdiction or the Incide nt Command Center, or designee. We do not propose requiring RHCs/F QHCs to provide information regarding their occupancy, as we propose for hospitals, since the term occupancy usually refers to bed occupancy in an inpatient facility. Q. Emergency Preparedness Regulation for E nd-Stage Renal Disease (ESRD) Facilities (§ 494.62) Sections 1881(b), 1881(c), and 1881(f)(7) of the Act establish requirements for End-Stage Renal Disease (ESRD) facilities. ESRD is a kidney impairment that is irreversible and permanent and requires either a regular course of dialysis or kidney transplantation to maintain life. Dialysis is th e process of cleaning the blood and removing excess fluid artificially with special equipment when the kidneys have failed. There are 5,923 Medicare-participating

ESRD facilities in the U.S. We addressed emergency preparedness requirements for ESRD facilities in the April 15, 2008 final rule (73 FR 20370) entitled, "Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule". Emergenc y preparedness requirements are located at § 494.60(d), Condition: Physical environment, St andard: Emergency preparedness. We propose to relocate these existing requirements to proposed § 494.62, Emergency preparedness. Current regulations include the requirement th at dialysis facilities be organized into

ESRD Network areas. Our regulations describe thes e networks at § 405.2110 as134

"CMS-designated ESRD Networks in which the approved ESRD facilities collectively provide the necessary care for ESRD patients." The ESRD Networks have an important role in an ESRD facility's response to emergencie s, as they often arrange for al ternate dialysis locations for patients and provide information and resources during emergency situations. As noted earlier, we do not propose incorporating th e ESRD Network requirements in to this proposed rule. We do not propose to require ESRD facilities to provide basic subsistence needs for staff and patients, whether they evacuate or shelter in pl ace, including food, water, and medical supplies; alternate sources of energy to maintain temperatur es to protect patient health and safety and for the safe and sanitary storage of provisions; emer gency lighting; and fire detection, extinguishing, and alarm systems; and sewage and waste disposal as we are proposing for hospitals at § 482.15(b)(1). At § 494.62(b), we propose to require fac ilities to address in their policies and procedures, fire, equipment or power failure s, care-related emerge ncies, water supply interruption, and natural disasters in the facili ty's geographic area. At § 482.15(b)(3), we propose that hospitals ha ve policies and procedures for the safe evacuation from the hospital, which includes co nsideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sour ces of assistance. We do not believe all of these requirements are appropr iate for ESRD facilities, which serve only outpatients. Therefore, at § 494.62(b)(2), we are proposing to require that ESRD facilities have policies and procedures for evacu ation from the facility, includ ing staff responsibilities and needs of the patients.135

At § 494.62(b)(6), we are proposing to require ESRD facilities to develop arrangements with other dialysis facilities or other providers to r eceive patients in the event of limitations or cessation of operations to ensure the continuity of services to dialysis facility patients. Experience has shown that ESRD facilities tend to use hospitals as back-up when hospital space and personnel need to be used to care for the sickest patients in the community during such emergencies. Thus, we want to emphasize th at an organized system of patient care among ESRD facilities during and surrounding emergency events enco mpasses having a robust system for back-up care available at th e various dialysis centers. At § 494.62(c)(7), dialysis facilities would be required to comply with the proposed requirement for hospitals at § 482.15(c)(7), with one exception. At § 494.62(c)(7), we propose to require dialysis facilities to have a communication plan th at include a means of providing

information about their needs a nd their ability to pr ovide assistance to the authority having jurisdiction or the Incide nt Command Center, or designee. We do not pr opose to require dialysis facilities to provide informati on regarding their occupancy, as we proposed for hospitals, since the term occupancy usually refers to bed occupancy in an inpatient facility. At § 494.62(d)(1)(i), we propose to require ES RD facilities to ensure that staff can demonstrate knowledge of various emergency proce dures, including: inform ing patients of what to do; where to go, including instructions for occa sions when the geographic area of the dialysis facility must be evacuated; whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact informa tion must include an a lternate emergency phone number for the facility for instan ces when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forw ard calls to a working136

phone number under such emergency conditions); and how to disconnect themselves from the dialysis machine if an emergency occurs. We would relocate existing requirements fo r patient training from § 494.60(d)(2) to proposed § 494.62(d)(3), patient orientation. In add ition, the facility would have to ensure that, at a minimum, patient care staff maintained current CPR certification and ensure that nursing staff were properly trained in the use of emergency equipment and emergency drugs. With respect to emergency preparedness, the releva nce of these requireme nts has already been established, and since they are ex isting regulations, they are sta ndard business practice in ESRD

facilities. Current § 494.60(d) would be redesignated. Current requirements for emergency plans at § 494.60 are captured within proposed § 494.62(a). Cu rrent language that de fines an emergency for dialysis facilities found at § 494.60(d) would be incorporated into proposed § 494.62(b). We would relocate existing requirements for emer gency equipment and emergency drugs found at existing § 494.60(d)(3) to § 494.62(b)(9). We would relocate the existing requirement at § 494.60(d)(4)(i) that requires the facility to have a plan to obtain emergency medical system assistance when needed to proposed § 494.62(b)(8). We would relocate th e current requirements at § 494.60(d)(4)(iii) for contacting the local emer gency preparedness agency at least annually to ensure that the agency is aware of dialysis fa cility's needs in the event of an emergency to proposed § 494.62(a)(4). We would also rede signate the current § 494.60(e) as § 494.60(d).137

III. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provi de 60-day notice in

the Federal Register and solicit public comment before a co llection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the inform ation collection burden on the affected public, including automate d collection techniques. We are soliciting public comment on each of th ese issues for the following sections of this document that contain information collection requirements (ICRs). A. Factors Influencing ICR Burden Estimates Please note that under this proposed rule, a hos pital’s ICRs would differ from the ICRs of other Medicare or Medicaid prov ider and supplier types. A signi ficant factor in the burden for each provider or supplier type would be whether th e type of facility provi des inpatient services, outpatient services, or both. Moreover, even where the proposed regulatory requirements are the same, certain factors would greatly affect th e burden for different providers and suppliers. Current Medicare or Medicaid regul ations for some providers and suppliers include requirements similar to those in this proposed regulation. Fo r example, existing regulations for RNHCIs and138

dialysis facilities require both types of facilities to have written disaster plans that address emergencies (42 CFR 403.742(a)(4) and 42 CFR 494.60(d)(4), respectively). Further, some accrediting organizations (AOs) that have deeming authority for Medicare providers and suppliers have emergency preparedne ss standards. Those organizations are: The Joint Commission (TJC), the American Osteopa thic Association (AOA), the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC), the American Association for Accreditation for Ambulatory Surgery Faciliti es, Inc. (AAAASF), and Det Norske Veritas Healthcare, Inc. (DNVHC). Each of these AOs has deeming authority for different types of facilities; for example, TJC has comprehens ive emergency preparedness requirements for hospitals. Thus, as noted in the hospital discussi on later in this section, we anticipate that TJCaccredited hospitals would have a smaller burden a ssociated with this proposed rule than many other providers or suppliers. In addition, many facilities already have begun preparing for emergencies. According to a study by Niska and Burt, virtually all hospitals already have plans to respond to natural disasters (Niska, R.W. and Burt, C.W. "Bio terrorism and Mass Casualty Preparedness in Hospitals: United States, 2003," CDC, A dvance Data, September 27, 2005 found at http://www.cdc.gov/nchs/data/ad/ad364.pdf ). Hospitals, as well as other health care providers, also receive grant funding for disaster or emergency preparedness from the federal and st ate governments, as well as other private and non-profit entities. However, we were unable to determine the amount of funding that has been granted to hospitals, the number of hospitals that received funding, or whether that funding would continue in a predictable manner. We also do not know how th e hospitals spent this funding. Therefore, in determining the burden fo r this proposed rule, we did not take into139

account any funding a hospital or other health ca re provider might have received from sources

other than Medicare or Medicaid.

B. Sources of Data Used in Estimates of Burden Hours and Cost Estimates

We obtained the data used in this discussi on on the number of the various Medicare and Medicaid providers and suppliers from Medicare’s Certification and Survey Provider Enhanced Reporting (CASPER) as of March 1, 2013. We have not included data for health care facilities

that are not Medicare or Medicaid certified. Unless otherwise indicated, we obtained all salary informati on for the different positions identified in the following assessments fr om the May 2011 National Occupational Employment and Wage Estimates, United States by the Bureau of Labor Statistics at http://www.bls.gov/oes/current/oes_nat.htm. We calculated the estimat ed hourly rates based upon the national median salary for that particul ar position, including benefits. Where we were able to identify positions linked to specific prov iders or suppliers, we used that compensation information. However, in some instances, we used a general position description, such as director of nursing, or we used information for comparable positions. For example, we were not able to locate specific inform ation for physicians who practice in hospices. However, since hospices provide palliative care, we used the compensation information for physicians who work in specialty hospitals. Based on our experience, certain providers a nd suppliers typically pay less than the median salary, in which case, we used a salary from a lower percentile. Salary may also be affected by the rural versus urban locations. For example, based on our experience with CAHs, they usually pay their administ rators less than the mean hourly wage for Health Service Managers in general medical and su rgical hospitals. Thus, we considered the impact of the rural140

nature of CAHs to estimate the hourly wage for CAH administrators and calculated total compensation by adding in an amount for fringe be nefits. According to the Bureau of Labor Statistics, wages and salaries accounted for about 70 percent of total employee compensation. (Bureau of Labor Statistics News Release, "Employer Cost Index—December 2011, retrieved

from www.bls.gov/news.release/pdf/eci.pdf ). Thus, we calculated to tal compensation using the assumption that salary accounts for 70 percent of total compensation. We would welcome any comments on the accuracy of our compensation estimates. Many health care providers and suppliers could reduce their burden by partnering or collaborating wi th other facilities to develop their emergency management plans or programs. In estimating the burden associated with this proposed rule, we also took into consideration the many free or low cost emergency management

resources health care facilities have available to them. Following is a list of some of the

available resources: Department of Health an d Human Services (HHS)

• http://www.phe.gov Office of the Assistant Secretary fo r Preparedness and Response (ASPR)

• http://www.phe.gov/about

Health Resources and Services Administra tion-Emergency Preparedness and Continuity of Operations

• http://www.hrsa.gov/emergency/

Centers for Medicare and Medicaid Services (CMS)

• www.cms.hhs.gov/Emergency/

Centers for Disease Control and Preven tion – Emergency Preparedness & Response

• www.emergency.cdc.gov141

Food and Drug Administration (FDA) – Emergency Preparedness and Response

• http://www.fda.gov/EmergencyPreparedness/default.htm

Substance Abuse and Mental Health Servi ces Administration (S AMHSA) – Disaster Readiness and Response

• http://www.samhsa.gov/Disaster/ National Institute for Occupational Safety and Health (NIOSH) – Business Emergency Management Planning

• www.cdc.gov/niosh/topics/emres/business.html Department of Labor (DOL), Occupational Safety and Health Ad ministration (OSHA)– Emergency Preparedness and Response

• www.osha.gov/SLTC/emergencypreparedness Federal Emergency Management Agency (FEMA)--State Offices and Agencies of Emergency Management – Contact Information

• http://www.fema.gov/about/contact/statedr.shtm

• http://www.fema.gov/plan-prepare-mitigate Department of Homeland Security (DHS)

• http://www.dhs.gov/training-technical-assistance We will discuss the burden for each provider an d supplier type included in this proposed rule in the order in which they appear in the CFR. C. ICRs Regarding Condition of Partic ipation: Emergency Preparedness (§ 403.748) Proposed § 403.748(a) would requi re Religious Nonmedical H ealth Care Institutions (RNHCIs) to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. We propose that the pl an must meet the requirements specified at142

§ 403.748(a)(1) through (4). We will discuss the burden for these activities individually beginning with the risk assessmen t requirement in § 403.748(a)(1). The current RNHCI CoPs already require RNHC Is to have a written disaster plan that addresses "loss of power, water, sewage, and other emergencies" (42 CFR 403.742(a)(4)). In addition, the CoPs also require RNHCIs’ to include measures to evaluate facility safety issues, including physical environment, in their qua lity assessment and performance improvement (QAPI) program (42 CFR 403.732(a)(1)(vi )). We expect that all RNHCIs have considered some of the risks likely to happen in their facility. However, we expect that all RNHCIs would need to review any existing risk assessment and perform th e tasks necessary to ensu re their assessment is documented and utilize a facility-based and community based all-hazards approach. We have not designated any specific process or format for RNHCIs to use in conducting their risk assessment because we believe they n eed the flexibility to determine how best to accomplish this task. However, we expect that they would obtain input from all of their major departments in the process of developing their risk assessments. Based on our experience with RNHCIs, we e xpect that complying with this requirement would require the involvement of an administrato r, the director of nursing, and the head of maintenance. It is important to note that RNHCIs do not provid e medical care to their patients. Depending upon the state in which they are locat ed, RNHCIs may not be licensed and may not have licensed or certified staff. RNHCIs genera lly do not compensate their staff at the same

level we have used to determine the burden fo r other health care providers and suppliers. Therefore, for the purpose of es timating the burden, we have us ed lower hourly wages for the RNHCI staff than for other providers and supplie rs whose staff must comply with licensing and

certification standards.143

We expect that to perform a risk assessment, the RNHCI’s administrator, the director of nursing, and the head of maintenance would attend an initial meeting; review relevant sections of the current risk assessment; prepare comments ; attend a follow-up mee ting; perform a final review, and approve the risk as sessment. We expect that th e director of nursing would coordinate the meetings, review and critique the current risk a ssessment, coordinate comments, develop the new risk assessment, a nd ensure that it is approved. We estimate that it would require 9 burden hours for each RNHCI to complete the risk assessment at a cost of $265. There are 16 RNHCIs . Therefore, it would require an estimated 144 annual burden hours (9 burden hours for eachRNHCI x 16 RNHCIs = 144 burden hours) for all 16 RNHCIs to comply with this requirement at a cost of $4,240 ($265 estimated cost for each RNHCI x 16 RNHCIs = $4,240 estimated cost). After conducting a risk assessment, RNHCIs would need to review, revise, and, if necessary, develop new sections for their emerge ncy plans. The current RNHCI CoPs require RNHCIs to have a written disaster plan for emergencies (42 CFR § 403. 742(a)(4)). However, based on our experience with RNHCIs, their plan s likely would address only evacuation from their facilities. We expect that all RNHCIs would need to review, revise, and develop new sections for their plans. We expect that the same individuals who were involved in developing the risk assessment would be involved in developing the emergency preparedness plan. However, we expect that it would require subs tantially more time to complete the plan than to complete the risk assessment. We estimate that complying with this requirement would require 12 burden hours for each RNHCI at a cost of $348. Therefor e, for all 16 RNHCIs to comply with these requirements would require an estimated 192 bu rden hours (12 burden hours for each RNHCI x144

16 RNHCIs = 192 burden hours) at a cost of $5,568 ($348 estimated cost for each RNHCI x 16 RNHCIs = $5,568 estimated cost). Under this proposed rule, RNHCIs would be required to review and update their emergency preparedness plans at least annually . For the purpose of determining the burden associated with this requirement, we would e xpect that RNHCIs alr eady review their plans annually. Based on our experience w ith Medicare providers and suppl iers, health care facilities generally have a compliance officer or other staff member who periodically reviews the facility’s program to ensure that it complies with all releva nt federal, state, and lo cal laws, regulations, and ordinances. While this requireme nt is subject to the PRA, we expect that complying with the requirement for an annual review of the emerge ncy preparedness plan would constitute a usual and customary business practice as defined at 5 CFR 1320.3(b)(2). Therefore, we have not assigned a burden. Proposed § 403.748(b) would require RNHCIs to develop and implement emergency preparedness policies and procedures in accord ance with their emergency plan based on the emergency plan set forth in paragraph (a) of this section, the risk assess ment at paragraph (a)(1) of this section, and the communica tion plan at paragraph (c) of this section. These policies and procedures would have to be reviewed and update d at least annually. At a minimum, we propose that the policies and procedures be require d to address the requirements specified in § 403.748(b)(1) through (8). The RNHCIs would need to review their policies and procedures and compare them to their emergency plan, ri sk assessment, and communication plan. Most

RNHCIs would need to revise th eir existing policies and procedur es or develop new policies and procedures.145

The current RNHCI CoPs require them to have written policies concer ning their services (42 CFR § 403.738). Thus, some R NHCIs may have some emerge ncy preparedness policies and procedures. However, based on our experien ce with RNHCIs, most of their emergency preparedness policies address only evacuation from the facility. We expect that these tasks would involve th e administrator, the di rector of nursing, and

the head of maintenance. All three would need to review an d comment on the RNHCI’s current policies and procedures. The director of nur sing would revise or de velop new policies and procedures, as needed, ensure that they are ap proved, and compile and disseminate them to the appropriate parties. We estimate that it would require 6 burden hours for each RNHCI to comply with this requirement at a cost of $164. Thus , it would require 96 burden hours (6 burden hours for each RNHCI x 16 RNHCIs = 96 burden hours) for all 16 RNHCIs to comply with the requirements in §403.748(b)(1) through (8) at a cost of $2,624 ($164 estimated cost for each RNHCI x 16 RNHCIs = $2,624 estimated cost). Proposed § 403.748(c) would require RNHCIs to develop and maintain an emergency preparedness communication plan that complies with both federal and state law and must be reviewed and updated at least annually. We pr opose that the communication plan include the information specified at § 403.748(c)(1) through (7 ). The burden associated with complying with this requirement would be the resources required to review and, if necessary, revise an existing communication plan or de velop a new plan. Based on our experience with RNHCIs, we expect that these activities would require the involvement of the RNHCI’s administrator, the director of nursing, and the head of maintena nce. We estimate that complying with this requirement would require 4 burden hours for ea ch RNCHI at a cost of $116. Thus, it would require an estimated 64 burden hours (4 burden hours for each RNHCI x 16 RNHCIs =64 burden146

hours) at a cost of $1,856 ($116 estimated cost for each RNHCI x 16 RNHCIs = $1,856 estimated cost). We propose that RNHCIs would also have to review and update their emergency preparedness communication plan at least annuall y. We believe that RNHCIs already review their emergency preparedness communication plans periodically. Thus, complying with this requirement would constitute a usual and custom ary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Therefore, we have not assigned a burden. Proposed § 403.748(d) would require RNHCIs to develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually. We are proposing that a RNHCI meet the requi rements specified at § 403.748(d)(1) and (2). Section 403.748(d)(1) would requ ire RNHCIs to provide ini tial training in emergency preparedness policies and procedur es to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, the R NHCI would have to provide training at least annually. Based on our experience, all RNHCIs have some type of emergency preparedness training program. However, all RNHCIs woul d need to compare their current emergency preparedness training programs to their risk assessments and updated emergency preparedness plans, policies and procedures, and communication plans and revi se or, if necessary, develop new sections for their training programs. We expect that complying with these requi rements would require the involvement of the

RNHCI administrator and the dir ector of nursing. We estimate that it would require 7 burden hours for each RNHCI to develop an emergency training program at a cost of $218. Thus, it would require an estimated 112 burden hours (7 burden hours for each RNHCI x 16 RNHCIs =147

112 burden hours) at a cost of $3,488 ($218 estim ated cost for each RNHCI x 16 RNHCI = $3,488 estimated cost). We are proposing that RNHCIs also revi ew and update their emergency preparedness training and testing programs at least annually. Based on our experience with Medicare providers and suppliers, health care facilities ge nerally have a compliance officer or other staff member who periodically reviews the facility’s program to ensure that it complies with all relevant federal, state, and lo cal laws, regulations, and ordinan ces. While this requirement is subject to the PRA, we expect th at complying with this requireme nt would constitute a usual and customary business practice as defined at 5 CFR 1320.3(b)(2). Therefore, we have not

calculated an estimate of the burden. Proposed § 403.748(d)(2) would require RNHC Is to conduct a paper-based, tabletop exercise at least annually. The RNHCI must also analyze its response to and maintain documentation of all tabletop exercises and emerge ncy events, and revise its emergency plan, as

needed. The burden associated with complying with this requirement would be the resources RNHCIs would need to develop the scenarios for the exercises and the necessary documentation. Based on our experience with RNHCIs, RNHCIs already conduct some type of exercise periodically to test their emer gency preparedness plans. However, we expect that RNHCIs would not be fully compliant with our proposed re quirements. We expect that the director of nursing would develop the scenar ios and required documentation. We estimate that these tasks would require 3 burden hours at a cost of $72 fo r each RNCHI. Based on this estimate, for all 16 RNHCIs to comply with these requirements would require 48 burden hours (3 burden hours148

for each RNHCI x 16 RNHCIs = 48 burden hours) at a cost of $1,152 ($72 estimated cost for each RNHCI x 16 RNHCI = $1,152 estimated cost).

TABLE 2: BURDEN HOURS AND CO ST ESTIMATES FOR ALL 16 RNHCIS TO COMPLY WITH THE ICRs CO NTAINED IN § 403.748 CONDITION: EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Number of Respondents Number of Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §403.748(a)(1) 0938-New 16 16 9 144 ** 4,240 0 4,240 §403.748(a)(1)-(4) 0938-New 16 16 12 192 ** 5,568 0 5,568 §403.748(b) 0938-New 16 16 6 96 ** 2,624 0 2,624 §403.748(c) 0938-New 16 16 4 64 ** 1,856 0 1,856 §403.748(d)(1) 0938-New 16 16 7 112 ** 3,488 0 3,488 §403.748(d)(2) 0938-New 16 16 3 48 ** 1,152 0 1,152 Totals 16 108 41 656 18,928 **The hourly labor cost is blended between the wages for multiple staffing levels. D. ICRs Regarding Condition for C overage: Emergency Preparedness (§ 416.54) Proposed § 416.54(a) would require Ambulatory Surgical Centers (ASCs) to develop and maintain an emergency preparedness plan and revi ew and update that plan at least annually. We propose that the plan must meet the require ments contained in § 416.54(a)(1) through (4).

We will discuss the burden for these activitie s individually below beginning with the risk assessment requirement in § 416.54(a)(1). We expect that each ASC would conduct a thorough risk assessment. This would require the ASC to develop a documented, facility-based and community-based risk assessment utilizing an al l-hazards approach. We expect that an ASC would consider its location and geographical area; patient population, including those with special needs; and the type of services the ASC has the ability to provide in an emergency. The ASC also would need to identify the measures it mu st take to ensure continuity of its operation, including delegations and succession plans. The burden associated with this requirement would be the time and effort necessary to perform a thorough risk assessment. There are 5,354 ASCs. The current regulations covering149

ASCs include some emergency preparedness requirements; however, those requirements primarily are related to internal emergencies, such as a fire. A significant factor in determining the burden is the accreditation stat us of an ASC. Of the 5,354 ASCs, 3,786 are non-accredited and 1, 568 are accredited. Of the 1,568 accredited ASCs, we estimate that 350 are accredited by The Joint Commission (TJC), 876 by the AAAHC, and additional facilities are accredited by th e AOA or the AAAASF. Th e accreditation standards for these organizations vary in their requireme nts related to emergenc y preparedness. The AOA’s standards are very similar to the curr ent ASC regulations. AAAASF does have some emergency preparedness requirements, such as requirements for responses or written protocols for security emergencies, for example, intruders and other threats to st aff or patients; power failures; transferring patients ; and emergency evacuation of the facility. However, the

accreditation standards fo r both the AOA and AAAASF would not significantly satisfy the ICRs contained in this proposed rule. Therefore, for the purpose of determining the burden imposed on ASCs by this proposed rule, we will includ e the ASCs that are accredited by both the AOA

and AAAASF with the non-accredited ASCs. TJC and AAAHC’s accreditation standards contain more extensive emergency preparedness requirements than the accreditation sta ndards of either AOA or AAAASF. For example, TJC standards contain requirements for risk assessments and an emergency management plan. AAAHC’s standards include requirements for both internal and external emergencies and drills for the facility’s internal emergency plan. Therefore, in discussing the individual burden requirements in this pr oposed rule, we will discuss the burden for the estimated 1,226 accredited ASCs by either the AAHC or TJC (876 AAAHC-accredited ASCs + 350 TJC-accredited ASCs = 1,226 ASCs accredited by TJC or AAAHC) separately from the150

remaining 4,128 (ASCs that are not accredited by an accrediting organization or accredited by the AOA and AAAASF). For some requirements, only the TJC accreditation standards are significantly like those in the proposed rule. For those requirements, we will analyze the 350 TJC-accredited ASCs sepa rately from the 5,004 non TJC-accredited ASCs (5,354 ASCs – 350 TJC-accredited ASCs = 5,004 non TJC-accredited ASCs). For the purpose of determining the burden for the TJC-accredited ASCs, we used TJC’s Comprehensive Accreditation Manual for Ambulatory Care: The Official Handbook 2008 (CAMAC). Concerning the requirement for a ri sk assessment in proposed § 416.54(a)(1), in the chapter entitled "Management of the Environmen t of Care" (EC), ASCs are required to conduct comprehensive, proactive risk assessment s (CAMAC, CAMAC Refreshed Core, January 2007, (CAMAC), TJC Standard EC.1.10, EP 4, p. EC-9). In addition, ASCs must conduct a hazard vulnerability analysis (HVA) (CAMAC, Sta ndard EC.4.10, EP 1, p. EC-12). The HVA requires the identification of potential emergencies and th e effects those emergencies could have on the ASC’s operations and the demand for its services (CAMAC, p. EC -12). We expect that TJCaccredited ASCs already conduct a risk assessment that complies with these requirements. If there are any tasks these ASCs need to complete to satisfy the requirement for a risk assessment, we expect that the burden imposed by this pr oposed requirement would be negligible. For the 350 TJC-accredited ASCs, the risk assessment requirement would constitute a usual and customary business practice. While this requireme nt is subject to the PRA, we expect that complying with this requirement would constitu te a usual and customary business practice as defined at 5 CFR 1320.3(b)(2). Therefore, we have not estimated the amount of regulatory

burden.151

For the purpose of determining the burden for the 876 AAAHC-accredited ASCs, we

used the Accreditation Handbook for Ambulator y Health Care 2008 (AHAHC). The AAAHC standards do not contain a speci fic requirement for the ASC to perform a risk assessment. However, in discussing the requirement for dri lls, the AAAHC notes that such drills should be appropriate to the facility’s activities and e nvironment (AHAHC, Accreditation Association for Ambulatory Health Care, Inc., Core Standards, Chapter 8. Facilities a nd Environment, Element E, p. 37). Therefore, we expect that in fu lfilling this core standard that the 876 AAAHCaccredited ASCs have performed some type of risk assessment. However, we do not expect that this would satisfy the requirement for a documen ted, facility-based and community-based risk assessment that addressed the elements required for the emergency plan. Therefore, the 876

AAAHC-accredited ASCs would be included in the burden analysis with the ASCs that are nonaccredited or are accredited by AOA and AAAASF for the risk assessment requirement for 5,004 non TJC-accredited ASCs (5,354 total ASCs - 350 TJC-accredited ASCs = 5,004 non TJC-accredited ASCs). We expect that all ASCs have already perfor med at least some of the work needed for a risk assessment. However, many probably have not performed a thorough risk assessment. Therefore, we expect that all non TJC-accredite d ASCs would perform thorough reviews of their current risk assessments, if they have them, a nd revise them to ensure they have updated the assessments and that they have included a ll of the requirements in proposed § 416.54(a). We have not designated any specific proce ss or format for ASCs to use in conducting their risk assessments because we believe that ASCs, as well as other health care providers and suppliers, need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we expect health care facil ities to, at a minimum, include input from all of152

their major departments in the process of deve loping their risk assessments. Based on our experience working with ASCs, we expect that conducting the risk assess ment would require the involvement of an administrator and a quality im provement nurse. We expect that to comply with the requirements of this s ubsection, both of these individuals w ould need to attend an initial meeting, review the current a ssessment, prepare their commen ts, attend a follow-up meeting, perform a final review, and approve the risk assessm ent. In addition, we expect that the quality improvement nurse would coordinate the meetings; perform an initial review of the current risk assessment; provide suggestions or a critique of the risk assessment; coordinate comments; revise the original risk assessment; develop any necessary sections for the risk assessment; and ensure that the appropriate par ties approve the new risk assessme nt. We estimate that complying with this risk assessment requ irement would require 8 burden hour s for each ASC at a cost of $477. Based on that estimate, it would require 40,032 burden hours (8 burden hours for each ASC x 5,004 non TJC-accredited ASCs = 40,032 burden hours) for all non TJC-accredited ASCs to comply with this risk assessment requireme nt at a cost of $2,386,908 ($477 estimated cost for each ASC x 5,004 ASCs = $2,386,908 estimated cost). After conducting the risk assessment, ASCs wo uld be required to develop and maintain emergency preparedness plans in accordan ce with § 416.54(a)(1) through (4). All TJCaccredited ASCs must already comply with many of the requirements in proposed § 416.54(a). All TJC-accredited ASCs are already required to develop and maintain a "written emergency management plan describing the process for di saster readiness and emergency management" (CAMAC, Standard EC.4.10, EP 3, EC-13). We e xpect that the TJC-accredited ASCs already have emergency preparedness plans that comply with these requirements. If there are any activities required to comply with these requir ements, we expect that the burden would be153

negligible. Thus, for 350 TJC-accredited ASCs, th is requirement would c onstitute a usual and customary business practice for these ASCs in accordance with 5 CFR 1320.3(b)(2). Therefore, we will not include this activity in the burden analysis for those ASCs. AAAHC-accredited ASCs are required to ha ve a "comprehensive emergency plan to

address internal and external emergencies" (AHAC, Chapter 8. Facilities and Environment, Element D, p. 37). However, we do not believe that this requirement ensures compliance with all of the requirements for an emergency pl an. We will include the 876 AAAAHC-accredited ASCs in the burden analysis for this requirement. We expect that the 5,004 non TJC-accredited ASCs have developed some type of emergency preparedness plan. However, under this proposed rule, all of these ASCs would have to review their current plans and compare them to the risk assessments they performed in accordance with proposed § 416.54(a)(1 ). The ASCs would then n eed to update, revise, and in some cases, develop new sections to ensure that their plans incorporate their risk assessments and address all of the proposed requirements. Th e ASC would also need to review, revise, and, in some cases, develop the delegations of aut hority and succession plans that ASCs determine are necessary for the appropriate initiation a nd management of their emergency preparedness plans. The burden associated with this requirement would be the time and effort necessary to develop an emergency preparedness plan that complies with all of the requirements in proposed § 416.54(a)(1) through (4). Based upon our expe rience with ASCs, we expect that the administrator and the quality improvement nurse who would be involved in the risk assessment would also be involved in developing the em ergency preparedness plan. We estimate that complying with this requirement would require 11 burden hours for each ASC at a cost of $653.154

Therefore, based on that estimate, for the 5,004 non TJC-accredited ASCs to comply with the requirements in this section would require burden hours (11 burden hours for each non TJCaccredited ASC x 5,004 non TJC-accredited ASCs = 55,044 burden hours) at a cost of $3,267,612 ($653 estimated cost for each non TJC-accredited ASC x 5,004 non TJC-accredited ASCs = $3,267,612). All of the ASCs would also be requir ed to review and update their emergency preparedness plans at least annually. For th e purpose of determining the burden for this requirement, we would expect that ASCs would review their plans annually. All ASCs have a professional staff person, generally a quality im provement nurse, whose responsibility entails ensuring that the ASC is deliver ing quality patient care and that the ASC is complying with regulations concerning patient ca re. We expect that the qual ity improvement nurse would be primarily responsible for the a nnual review of the ASC’s emer gency preparedness plan. We expect that complying with this requirement would constitute a usual and customary business practice for ASCs in accordance with 5 CFR 1320.3(b )(2). Therefore, we will not include this activity in the burden analysis. Section 416.54(b) proposes that each ASC be required to develop and implement emergency preparedness policies and procedures , based on the emergency plan set forth in paragraph (a) of this section, th e risk assessment at paragraph (a)(1) of this section, and the communication plan set forth in paragraphs (c) of this section. We would require ASCs to review and update these policies an d procedures at least annually. These policies and procedures would be required to include, at a minimum, the requirements listed at § 416.54(b)(1) through (7). We expect that ASCs would develop emer gency preparedness policies and procedures based upon their risk assessments, emergency prep aredness plans, and communication plans.155

Therefore, ASCs would need to thoroughly revi ew their emergency preparedness policies and procedures and compare them to all of the info rmation previously noted. The ASCs would then need to revise, or in some cases, develop new po licies and procedures that would ensure that the ASCs’ emergency preparedness plans address the specific proposed elements. The TJC accreditation standards already requi re many of the specific elements that are required in this subsection. For example, in the chapter entitled "Leadership" (LD), TJC-accredited ASCs are required to "develop po licies and procedures that guide and support patient care, treatment, and services" (CAM AC, Standard LD.3.90, EP 1, p. LD-12a). In addition, TJC-accredited ASCs must already a ddress or perform a HVA; processes for communicating with and assigning staff under emerge ncy conditions; provision of subsistence or critical needs; evacuation of the facility; and alternate sources fo r fuel, water, electricity, etc. (CAMAC, Standard EC.4.10, EPs 1, 7-10, 12, and 20, pp. EC-12-13). They must also critique their drills and modify their em ergency management plans in response to the critiques (CAMAC, Standard EC.4.20, EPs 12-16, pp. EC-14-14a). In the chapter entitle d, "Management of Information" (IM), they are required to protect and preserve the privacy and confidentiality of sensitive data (CAMAC, Standard IM.2.10, EPs 1 a nd 9, p. IM-6). If TJC-accredited ASCs have any tasks required to satisfy these requirements, we expect they would constitute only a negligible burden. For the 350 TJC-accredited ASCs, the requirement for emergency preparedness policies and procedures would constitute a usual and customary business practice in accordance with 5 CFR 1320.3(b)(2). Therefor e, we will not include this activity in the burden analysis for these 350 TJC-accredited ASCs. AAAHC standards require ASCs to have "the necessary personnel, equipment and procedures to handle medical and other emergencie s that may arise in co nnection with services156

sought or provided" (AHAHC, Chapter 8. Faci lities and Environment, Element B, p. 37). Although, we expect that AAAHC-accredited ASCs probably already have policies and procedures that address at least some of the requirements, we expect that they will sustain a considerable burden in satisfy ing all of the requirements. We will include the AAAHCaccredited ASCs with the non-accredited ASCs in determining the burden for the requirements in proposed §416.54(b). We expect that all of the 5,004 non TJC-accredited ASCs have some emergency preparedness policies and procedures. However, we expect that all of these ASCs would need to review their policies and procedures and revise their policies a nd procedures to ensure that they address all of the proposed requirements. We e xpect that the quality improvement nurse would initially review the ASC’s emergency prepar edness policies and procedures. The quality improvement nurse would send any recommendati ons for changes or additional policies or procedures to the ASC’s administrator. The ad ministrator and quality improvement nurse would need to make the necessary revisions and draf t any necessary policies and procedures. We estimate that for each non TJC-accredited ASC to comply with this proposed requirement would require 9 burden hours at a cost of $505. For all 5,004 ASCs to comply with this requirement would require an estimated 45,036 burden hours (9 burden hours for each non TJC-accredited ASC x 5,004 non TJC-accredited ASCs = 45,036) at a cost of $2,527,020. ($505 estimated cost for each non TJC-accredited ASC x 5,004 ASCs = $2,527,020 estimated cost). Proposed § 416.54(c) would require each ASC to develop and maintain an emergency preparedness communication plan that complies with both federal and state law. We also propose that ASCs would have to review and update these plans at least annually. These communication plans would have to include the in formation listed in § 416.54(c)(1) through (7).157

The burden associated with developing a nd maintaining an emergency preparedness communication plan would be the time and effort necessary to review, re vise, and, if necessary, develop new sections for the ASC’s emergency pr eparedness communications plan to ensure that it satisfied these requirements. The TJC-accredited ASCs are required to have a plan that "identif ies backup internal and external communication systems in the event of failure during emergencies" (CAMAC, Standard EC.4.10, EP 18, p. EC-13). There are also requi rements for identifying, notifying, and assigning staff, as well as notifying external authorities (CAMAC, Standard EC.4.10, EPs 7-9, p. EC-13). In addition, the facility’s plan must provide for controlling information about patients (CAMAC, Standard EC.4.10, EP 10, p. EC-13). If any revisions or additions are nece ssary to satisfy the proposed requirements, we expect the revisions or additions would be th ose incurred during the course of normal business and thereby impose no additional burden. Thus, for the TJCaccredited ASCs, the proposed requirements for the emergency preparedness communication plan would constitute a usual and customary business practice fo r ASCs as stated in 5 CFR 1320.3(b)(2). Thus, we will not include this activ ity by these TJC-accredited ASCs in the burden analysis. The AAAHC standards do not have a specific requirement for a communication plan for emergencies. However, AAAHC-accredited AS Cs are required to have the "necessary personnel, equipment and procedures to handle me dical and other emergencies that may arise in connection with services sought or provided (AAAHC, 8. Facilities and Environment, Element B, p. 37) and "a comprehensive emergency plan to address internal and external emergencies" (AAAHC, 8. Facilities and Environment, Element D, p. 37). Since communication is vital to any ASC’s operations, we expect that communicatio ns would be included in the AAAHC-accredited158

ASC’s plans and procedures. However, we do not be lieve that these requirements ensure that the AAAHC-accredited ASCs are already fully satisfying all of the requirements . Therefore, we will

include the AAAHC-accredited ASCs in with the non-accredited ASCs in determining the burden for these requirements for a total of 5,004 non TJC-accredited ASCs (5,354 total ASCs – 350 TJC accredited ASCs). We expect that all non TJC-accredited ASCs currently have some type of emergency preparedness communication plan. It is standard practice in the health care industry to have and

maintain contact information for both staff and out side sources of assistan ce; alternate means of communications in case there is an interruption in phone service to the facility, such as cell phones; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for their pa tients. We expect that all ASCs already satisfy the requirements in proposed § 416.54(c)(1) through (4). However, for the requirements in proposed § 416.54(c)(5) through (7), all ASCs would need to revi ew, revise, and, if necessary, develop new sections for their plans to ensure that they include all of the proposed requirements. We expect that this would re quire the involvement of the AS C’s administrator and a quality improvement nurse. We estimate that complying with this proposed requirement would require 4 burden hours at a cost of $227. Therefore, for all non TJC-accredited ASCs to comply with the requirements in this section would require an estimated 20,016 burden hours (4 hours for each non TJC-accredited ASC x 5,004 non TJC-accredited ASCs = 20,016 burden hours) at a cost of $1,135,908 ($227 estimated cost for each non TJC-accredited ASC x 5,004 non TJC-accredited ASCs = $1,135,908 estimated cost). We also propose that ASCs must revi ew and update their emergency preparedness communication plans at least annua lly. We believe that ASCs al ready review their emergency159

preparedness communication plans periodically. Therefore, complying with this requirement would constitute a usual and customary business practice for ASCs and w ould not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 416.54(d) would require ASCs to develop and maintain emergency preparedness training and testing programs that ASCs must review and update at least annually. Specifically, ASCs must meet the requirements listed at proposed § 416.54(d)(1) and (2). The burden associated with complying with these requirements would be the time and effort necessary for an ASC to review, update, a nd, in some cases, develop new sections for its emergency preparedness training program. We e xpect that all ASCs al ready provide training on their emergency preparedness policies and proce dures. However, all ASCs would need to review their current training a nd testing programs and compare th eir contents to their risk assessments, emergency preparedness plans, polic ies and procedures, and communication plans. Proposed § 416.54(d)(1) would require ASCs to provide initial training in their emergency preparedness policies and procedures to all new and existi ng staff, individuals providing on-site services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. ASCs would have to ensure that their staff can demonstrate knowledge of emergency procedures . Thereafter, ASCs would have to provide the training at least annually. TJC-accredited ASCs must provide an initial orientation to their staff and independent practitione rs (CAMAC, Standard 2.10, HR-8). They must also provide "on-going education, including in-s ervices, training, and other activities" to maintain and improve staff competence (CAMAC, Standard 2.30, HR-9). We expect that these TJC-accredited ASCs include some training on thei r facilities’ emergency preparedness policies and procedures in their current training programs. However, these requirements do not contain160

any requirements for training volunteers. Thus , TJC accreditation standards do not ensure that TJC-accredited ASCs are already fulfilling all of the proposed requirements, and we expect that the TJC-accredited ASCs will incur a burden comply ing with these requirements. Therefore, we will include these TJC-accredited ASCs in determining the burden for these requirements. The AAAHC-accredited ASCs are already requi red to ensure that "all health care professionals have the necessary and appropriate training and skills to deliver the services provided by the organization" (AAAHC, Chapter 4. Quality of Care Provided, Element A, p. 28). Since these ASCs are required to have an emergency plan that addresses internal and external emergencies, we expect that all of the AAAHC-accredited ASCs already are providing some training on their emergency preparedne ss policies and procedures. However, this requirement does not include any requirement for a nnual training or for any training for staff that are not health care professionals. This AAAHC -accredited requirement does not ensure that these ASCs are already complying with the propo sed requirements. Therefore, we will include these AAAHC-accredited ASCs in determining th e information collection burden for these requirements. Based upon our experience with ASCs, we expect that all 5,354 ASCs have some type of emergency preparedness training program. We al so expect that these ASCs would need to review their training programs and compare them to their risk assessments, emergency preparedness plans, policies and procedures, an d communication plans. The ASCs would then need to make any necessary revisions to their tr aining programs to ensure they comply with these requirements. We expect that complying with th is requirement would requ ire the involvement of an administrator and a quality improvement nurse. We estimate that for each ASC to develop a comprehensive emergency training program woul d require 6 burden hours at a cost of $329.161

Therefore, the estimated annual burden for all 5,354 ASCs to comply with these requirements is 32,124 burden hours (6 burden hours x 5,354 ASCs =32,124 burden hours) at a cost of $1,761,466 ($329 estimated cost for each ASC x 5,354 ASCs = $1,761,466 estimated cost). We propose that ASCs would also have to review and update their emergency preparedness training programs at least annually. For the purpose of determining the burden for this requirement, we would e xpect that ASCs would review their emergency preparedness training program annually. We expect that all ASCs have a quality improvement nurse responsible for ensuring that th e ASC is delivering quality patie nt care and that the ASC is complying with patient care regulations. We e xpect that the quality improvement nurse would be primarily responsible for th e annual review of the ASC’s emergency preparedness training program. Thus, complying with this requireme nt would constitute a usual and customary business practice for ASCs in accordance with 5 CFR 1320.3(b)(2). Thus, we will not include this activity in this burden analysis. Proposed § 416.54(d)(2) would require ASCs to participate in a community mock disaster drill and, if one was not available, conduct an individual , facility-based mock disaster drill, at least annually. ASCs would also have to conduct a pa per-based, tabletop exercise at least annually. If the ASC experiences an actual natural or man-made emergency that requires activation of their emergency plan, the ASC wo uld be exempt from the requirement for a community or individual, facility-based mock disa ster drill for 1 year following the onset of the actual event. ASCs would also be required to analyze their response to and maintain documentation of all drills, tablet op exercises, and emergency even ts, and revise their emergency plans, as needed. To comply with this requirem ent, ASCs would need to develop a scenario for

each drill and exercise. ASCs would also need to develop the documentation necessary for162

recording what happened during drills, exercise s, and emergency events and analyze their responses to these events. TJC-accredited ASCs are required to regularly test their emergency management plans at least twice a year, critique each exercise, and modify their emergency management plans in response to those critiques (CAMAC, Standa rd EC.4.20, EP 1 and 12-16, p. EC-14-14a). In addition, the scenarios for these drills should be r ealistic and related to the priority emergencies the ASC identified in its HVA (CAMAC, Standard EC.4.20, EP 5, p. EC-14). However, the EPs

for this standard do not contain any requirements for the drills to be community-based; for there to be a paper-based, tabletop exercise; or for the ASCs to maintain documentation of these drills, exercises, or emergency events. These TJC accr editation requirements do not ensure that TJCaccredited ASCs are already complying with thes e requirements. Therefore, the TJC-accredited

ASCs will be included in the burden estimate. The AAAHC-accredited ASCs already are requi red to perform at least four drills annually of their internal emergency plans ( AAAHC, Chapter 8. Facilities and Environment, Element E, p. 37). However, there is no require ment for a paper-based, tabletop exercise; for a community-based drill; or for the ASCs to mainta in documentation of their drills, exercises, or emergency events. This AAAHC accreditat ion requirement does not ensure that AAAHCaccredited ASCs are already complying with these requirements. Therefore, the AAAHCaccredited ASCs will be included in the burden estimate. Based on our experience with ASCs, we e xpect that all of th e 5,354 ASCs would be required to develop scenarios for a mock disaster drill and a paper-base d, tabletop exercise and the documentation necessary to record and anal yze these events, as well as any emergency events. Although we believe many ASCs may ha ve developed scenarios and documentation for163

whatever type of drills or exercises they had previously performed, we expect all ASCs would need to ensure that the testing of their em ergency preparedness plans comply with these requirements. Based upon our experience with AS Cs, we expect that complying with this requirement would require the involvement of an administrator and a quality improvement nurse. We estimate that for each ASC to comply would require 5 burden hours at a cost of $278. Therefore, for all 5,354 ASCs to comply with this requirement would require an estimated 26,770 burden hours (5 burden hours for each AS C x 5,354 ASCs = 26,770 burden hours) at a cost of $1,488,412 ($278 estimated cost for each ASC x 5,354 ASCs = $1,488,412 estimated cost).164

TABLE 3: BURDEN HO URS AND COST ESTIMATE S FOR ALL 5,354 ASCs TO COMPLY WITH THE ICRs CONTAINE D IN §416.54 CONDITION: EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §416.54(a)(1) 0938-New 5,004 5,004 8 40,032 ** 2,386,908 0 2,386,908 §416.54(a)(1)-(4) 0938-New 5,004 5, 004 11 55,044 ** 3,267,612 0 3,267,612 §416.54(b) 0938-New 5,004 5,004 9 45,036 ** 2,527,020 0 2,527,020 §416.54(c) 0938-New 5,004 5,004 4 20,016 ** 1,135,908 0 1,135,908 §416.54(d)(1) 0938-New 5,354 5,354 6 32,124 ** 1,758,176 0 1,758,176 §416.54(d)(2) 0938-New 5,354 5,354 5 26,770 ** 1,488,412 0 1,488,412 Totals 5,354 30,724 219,022 12,564,036 **The hourly labor cost is blended between the wages for multiple staffing levels. E. ICRs Regarding Condition of Par ticipation: Emergency Preparedness (§ 418.113) Proposed § 418.113(a) would require hospices to develop and maintain an emergency preparedness plan that must be reviewed and upda ted at least annually. We propose that the plan meet the criteria listed in pr oposed § 418.113(a)(1) through (4). Although proposed § 418.113(a) is entitled "Eme rgency Plan" and the requirement for the plan is stated first, the emergency plan mu st include and be based upon a risk assessment. Therefore, since hospices must perform their ri sk assessments before beginning, or at least before they complete, their plans, we will di scuss the burden related to performing the risk

assessment first. Proposed § 113(a)(1) would requ ire all hospices to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. We expect that in performing a risk assessment, a hospice would need to consider it s physical location, the geographic area in which it is lo cated, and its patient population. The burden associated with this requirement would be the time and effort necessary to perform a thorough risk assessment. There ar e 3,773 hospices. There are 2,584 hospices that provide care only to patients in their homes and 1,189 hospices that offer inpatient care directly165

(inpatient hospices). When we use the term “inpatient hospice,” we are referring to a hospice that operates its own inpatient care facility; that is, the hospice provides the inpatient care itself. By “outpatient hospices”, we are referring to hospices that only provi de in-home care, and

contract with other facilities to provide inpatient care. The cu rrent requirements for hospices contain emergency preparedness requirements fo r inpatient hospices only (42 CFR 418.110). Inpatient hospices must have "a written disaster prep aredness plan in effect for managing the consequences of power failures, natural disasters, and other emer gencies that would affect the hospice’s ability to provide care, " as stated in 42 CFR 418.110(c )(1)(ii). Thus, we expect inpatient hospices already have performed some type of risk assessment during the process of developing their disaster prepar edness plan. However, these risk assessments may not be documented or may not address all of the re quirements under proposed § 418.113(a). Therefore, we believe that all inpatient hospices would have to conduct a thorough review of their current risk assessments and then perform the necessary tasks to ensure that their facilities’ risk assessments comply with these requirements. We have not designated any specific process or format for hospices to use in conducting their risk assessments because we believe hospice s need maximum flexibility in determining the best way for their facilities to accomplish this tas k. However, we believe that in the process of developing a risk assessment, health care inst itutions should include re presentatives from or obtain input from all of their major department s. Based on our experience with hospices, we expect that conducting the risk assessment would require th e involvement of the hospice’s administrator and an interdisciplinary group (I DG). The current Hospice CoPs require every hospice to have an IDG that include s a physician, registered nurse, social worker, and pastoral or other counselor. The responsibilities of one of a hospice’s IDGs, if they have more than one,166

include the establishment of "policies governi ng the day-to-day provisi on of hospice care and services" (42 CFR 418.56(a )(2)). Thus, we believe the IDG w ould be involved in performing the

risk assessment. We expect that members of the IDG would a ttend an initial meeting; review any existing risk assessment; develop comments and recomme ndations for changes to the assessment; attend a follow-up meeting; perform a final review; and a pprove the risk assessmen t. We expect that the administrator would coordinate the meetings, perform an initial review of the current risk assessment, provide a critique of the risk as sessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and ensure that the necessary staff approves the

new risk assessment. We believe it is likel y that the administrator would spend more time reviewing and working on the risk assessment th an the other individual s in the IDG. We estimate it would require 10 burden hours to review and update the risk assessment at a cost of $496. There are 1,189 inpatient hospices. Therefore, based on that estimates, it would require 11,890 burden hours (10 burden hours for each inpatient hospice x 1,189 inpatient hospices 11,890 burden hours) for all inpatient hospices to co mply with this requirement at a cost of $589,744 ($496 estimated cost for each inpati ent hospice x 1,189 inpatient hospices = $589,744 estimated cost). There are no emergency preparedness requi rements in the current hospice CoPs for hospices that provide care to patien ts in their homes. However, it is standard practice for health care facilities to plan and prepare for common emergencies, such as fires, power outages, and storms. Although we expect that these hospices have considered at least some of the risks they might experience, we anticipate that these facili ties would require more time than an inpatient hospice to perform a risk assessment. We es timate that each hospice that provides care to167

patients in their homes would require 12 burden hours to develop its risk assessment at a cost of $593. Therefore, based on that estimate, for all 2,584 hospices that provide care to patients in their homes, it would require 31,008 burden hour s (12 burden hours for each hospice x 2,584 hospices =31,008 burden hours) to comply with this requirement at a cost of $1,532,312 ($593 estimated cost for each hospice x 2,584 hospices = $1,532,312 estimated cost). Based on the previous calculations, we estimate that for all 3,773 hospices to develop a risk assessment would require 42,898 burden hours at a cost of $2,122,056. After conducting the risk assessments, hospi ces would have to develop and maintain emergency preparedness plans that they would ha ve to review and update at least annually. We expect all hospices to compare their current emergency plans, if they have them, to the risk assessments they performed in accordance with proposed § 418.113(a)(1). In addition, hospices would have to comply with the requirements in § 418.113(a)(1) through (4). They would then need to review, revise, and, if necessary, develop new sections of their plans to ensure they comply with these requirements. The current hospice CoPs require inpatient hospices to have "a written disaster preparedness plan in effect for managing the cons equences of power failures, natural disasters, and other emergencies that would affect th e hospice’s ability to provide care" (42 CFR 418.110(c)(1)(ii)). We believe that all inpatient hospices already have some type of emergency preparedness or disaster plan. However, their plans may not address all likely medical and nonmedical emergency events identifie d by the risk assessment. Further, their plans may not include strategies for addressing likely em ergency events or address their patient population; the type of services they have the ability to provide in an emergency; or continuity of operations, including delegations of authority and succession plans. We expect that an inpatient hospice would have to168

review its current plan and compare it to its risk assessment, as well as to the other requirements we propose. We expect that most inpatient hospices would need to update and revise their existing emergency plans, and, in some cases, deve lop new sections to comply with our proposed requirements. The burden associated with this proposed requirement would be the time and effort necessary to develop an emergency preparedness plan or to review, revise, and develop new sections for an existing emergency plan. Base d upon our experience with inpatient hospices, we expect that these activities would require the i nvolvement of the hospice’s administrator and an IDG, that is, a physician, registered nurse, so cial worker, and counsel or. We believe that developing the plan would require more time to complete than the risk assessment. We expect that these individuals would have to attend an initial m eeting, review relevant sections of the facility’s current emergency prep aredness or disaster plan (s), develop comments and recommendations for changes to the facility ’s plan, attend a follo w-up meeting, perform a final review, and approve the emergency plan. We expect that the administrator would probably coordinate the meetings, perform an initial re view of the current emergency plan, provide a critique of the emergency plan, offer suggested revisions, coordinate co mments, develop the new emergency plan, and ensure that the necessary parties approve the new emergency plan. We expect the administrator w ould probably spend more time reviewing and working on the emergency plan than the other individuals. We estimate that it would require 14 burden hours for each inpatient hospice to develop its emerge ncy preparedness plan at a cost of $742. Based on this estimate, it would require 16,646 bur den hours (14 burden hours for each inpatient hospice x 1,189 inpatient hospices = 16,646 burden hours) for all inpatient hospices to complete169

their plans at a cost of $882,238 ($742 estimated co st for each inpatient hospice x 1,189 inpatient hospices = $882,238 estimated cost). As discussed earlier, we have no current re gulatory requirement for hospices that provide care to patients in their homes to have emergenc y preparedness plans. However, it is standard practice for health care providers to plan for co mmon emergencies, such as fires, power outages, and storms. Although we expect that these hospi ces already have some type of emergency or disaster plan, each hospice would need to review its emergency plan to ensure that it addressed

the risks identified in its risk assessment and complied with the proposed requirements. We expect that an administrator and the individua ls from the hospice’s IDG would be involved in reviewing, revising, and developing a facility’s emergency plan. However, since there are no current requirements for hospices that provide car e to patients in their homes have emergency plans, we believe it would require more time for each of these hospices than for inpatient hospices to complete an emergency plan. We estim ate that for each hospice that provides care to patients in their homes to comply with this proposed requirement would require 20 burden hours at an estimated cost of $1,046. Based on that estimate, for all 2,584 of these hospices to comply with this requirement would require 51,680 burden hours (20 bur den hours for each hospice x 2,584 hospices = 51,680 burden hours) at a cost of $2,702,864 ($1,046 estimated cost for each hospice x 2,584 hospices = $2,702,864 estimated cost). We estimate that for all 3,773 hospices to develop an emergency preparedness plan would require 68,326 burde n hours at a cost of $3,585,102. Hospices would also be re quired to review and update their emergency preparedness plans at least annually. The cu rrent hospice CoPs require inpa tient hospices to periodically

review and rehearse their disa ster preparedness plan with th eir staff, including non-employee170

staff (42 CFR 418.110(c)(1)(ii)). For purposes of this burden estimate, we would expect that under this proposed rule, inpatient hospices w ould review their emergency plans prior to reviewing them with a ll of their employees and that th is review would occur annually. We expect that all hospices, both inpatient and those that provide care to patients in their homes, have an administrator who is responsible for the day-to-day operation of the hospice. Day-to-day operations would includ e ensuring that all of the hospi ce’s plans are up-to-date and in compliance with relevant federal, state, a nd local laws, regulations , and ordinances. In addition, it is standard practice in health care organizations to have a professional employee, generally an administrator, who periodically reviews their plans a nd procedures. We expect that complying with this requirement would constitu te a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Thus, we will not include this activity in the burden analysis. Proposed § 418.113(b) would require each hosp ice to develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this se ction, and the communication plan at paragraph (c) of this secti on. It would also require hospi ces to review and update these policies and procedures at least annually. At a minimum, the hospice’s policies and procedures would be required to address the requirements listed at § 418.113((b)(1) through (6). We expect that all hospices have some em ergency preparedness policies and procedures because the current hospice CoPs for inpatient hosp ices already require them to have "a written disaster preparedness plan in effect for managi ng the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ab ility to provide care" (42 CFR 418.110(c)(1)(ii)). In addition, the re sponsibilities for at least one of a hospice’s IDGs, if they171

have more than one, include the establishment of "policies governing the day-to-day provision of hospice care and services" (42 CFR 418.56(a)(2)). Ho wever, we also expect that all inpatient hospices would need to review th eir current policies and procedur es, assess whether they contain everything required by their facilities’ emergenc y preparedness plans, and revise and update them as necessary. The burden associated with reviewing, revising, and updating a hospice’s emergency policies and procedures would be the resources needed to ensu re they comply with these requirements. Since at least one of a hospi ce’s IDGs would be res ponsible for developing policies that govern the daily care and servic es for hospice patients (42 CFR 418.56(a)(2)), we expect that an IDG would be involved with re viewing and revising a hos pice’s existing policies and procedures and developing any necessary new policies and procedures. We estimate that an inpatient hospice’s compliance with this requirement would require 8 burden hours at a cost of $399. Therefore, based on that estimate, all 1,189 inpatient hospices’ compliance with this requirement would require 9,512 burden hours (8 burden hours for each inpatient hospice x 1,189 inpatient hospices = 9,512 burden hours) at a cost of $474,411 ($399 estimated cost for each inpatient hospice x 1,189 inpatient hospices = $474,411 estimated cost). Although there are no existing regulatory require ments for hospices that provide care to patients in their homes to have emergency prepar edness policies and pro cedures, it is standard practice for health care organizations to prepare for common emergencies, such as fires, power outages, and storms. We expect that these hos pices already have some emergency preparedness policies and procedures. Howeve r, under this proposed rule, the IDG for these hospices would need to accomplish the same tasks as described ea rlier for inpatient hospice s to ensure that these policies and procedures comply w ith the proposed requirements.172

We estimate that each hospice’s complia nce with this require ment would require 9 burden hours at a cost of $454. Therefore, based on that esti mate, all 2,584 hospices’ that provide care to patients in their homes to co mply with this requir ement would require 23,256 burden hours (9 burden hours for each hospice x 2,584 hospices = 23,256 burden hours) at a cost of $1,173,136 ($454 estimated cost for each hospice x 2,584 hospices = $1,173,136 estimated cost). Thus, we estimate that development of em ergency preparedness policies and procedures for all 3,773 hospices would require 32,768 burden hours at a cost of $1,647,547. Proposed § 418.113(c) would require a hospice to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. Hospices would also have to review and update their pl ans at least annually. The communication plan would have to include the requirement s listed at § 418.113(c)(1) through (7). We believe that all hospices already ha ve some type of emergency preparedness communication plan. Although only inpatient hospi ces have a current requirement for disaster preparedness (42 CFR 418.110(c)), it is standard practice for h ealth care organizations to

maintain contact information for their staff and fo r outside sources of assistance; alternate means

of communications in case there is an interr uption in phone service to the organization (for example, cell phones); and a method for shari ng information and medical documentation with other health care providers to ensure continuity of care for their patients. However, many hospices, both inpatient hospices an d hospices that provide care to patients in their homes, may not have formal, written emergency preparedness communication plans. We expect that all hospices would need to review, update, and in so me cases, develop new sections for their plans173

to ensure that those plans include all of th e elements we propose requiring for hospice communication plans. The burden associated with complying with this requirement would be the resources required to ensure that the hospice’s emer gency communication plan complied with these requirements. Based upon our experience with ho spices, we anticipate that satisfying these requirements would require only the involvement of the hospice’s administrator. Thus, for each hospice, we estimate that complying with this re quirement would require 3 burden hours at a cost of $165. Therefore, based on that estimate, co mpliance with this re quirement for all 3,773 hospices would require 11,319 burden hours (3 burd en hours for each hospice x 3,773 hospices = 11,319 burden hours) at a cost of $622,545 ($165 es timated cost for each hospice x 3,773 hospices = $622,545 estimated cost). We are proposing that a hospice review and update its emergency preparedness communication plan at least annu ally. We believe that all ho spices already review their emergency preparedness communication plans pe riodically. Thus, compliance with this requirement would constitute a usual and cust omary business practice for hospices and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 418.113(d) would require each hospice to develop and maintain an emergency preparedness training and testing pr ogram that would be reviewed and updated at least annually. Proposed § 418.113(d)(1) would require hospices to provide initial training in emergency preparedness policies and procedures to all hospice employees, consistent with their expected roles, and maintain documentation of the training. The hospice would also have to ensure that their employees could demonstrat e knowledge of their em ergency procedures. Thereafter, the hospice would have to provide emergency prepare dness training at least annually.174

Hospices would also be required to periodi cally review and rehearse their emergency preparedness plans with their employees, with special emphasis placed on carrying out the procedures necessary to prot ect patients and others. Under current regulations, a ll hospices are required to provid e an initial orientation and in-service training and educational programs, as necessary, to each employee (§ 418.100(g)(2) and (3)). They must also provide employee or ientation and training consistent with hospice industry standards (42 CFR 418.78(a)). In addition, inpatient hospice s must periodically review and rehearse their disaster preparedness plans w ith their staff, including non-employee staff (42 CFR 418.110(c)(1)(ii)). We expect that all hospi ces already provide trai ning to their employees on the facility’s existing disaster plans, policies, and procedures . However, under this proposed rule, all hospices would need to review their current trai ning programs and compare their contents to their updated emergency prepare dness plans, policies and procedures, and communications plans. Hospices would then need to review, revise, and in some cases, develop new material for their training programs so th at they complied with these requirements.

The burden associated with the aforemen tioned requirements would be the time and effort necessary for a hospice to bring itself in to compliance with the requirements in this section. We expect that compliance with this requirement would require the involvement of a registered nurse. We expect that the regist ered nurse would compare the hospice’s current training program with the facility’s emergency preparedness plan, policie s and procedures, and communication plan, and then make any necessary revisions, including the development of new training material, as needed. We estimate that these tasks would require 6 burden hours at a cost of $252. Based on this estimate, compliance by all 3,773 hospices would require 22,638 burden hours (6 burden hours for each hospice x 3,773 hospi ces = 22,638 burden hours) at a cost of175

$950,796 ($252 estimated cost for each hospice x 3,773 hospices = $950,796 estimated cost). We are proposing that hospi ces also be required to revi ew and update their emergency preparedness training programs at least annually. We believe that hospices already review their emergency preparedness training programs peri odically. Therefore, compliance with this requirement would constitute a usual and cust omary business practice for hospices and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 418.113(d)(2) would require hospice s to participate in a community mock disaster drill, and if one were not available, c onduct an individual, facil ity-based mock disaster drill, and a paper-based, tabletop exercise at least annually. Hosp ices would also be required to analyze their responses to and maintain documenta tion of all their drills, tabletop exercises, and emergency events, and revise their emergency plans, as needed. To comply with this requirement, a hospice would need to develop scenar ios for their drills and exercises. A hospice also would have to develop the required documentation. Hospices would also have to periodica lly review and rehearse their emergency preparedness plans with their staff (including nonemployee staff), with special emphasis on carrying out the procedures necessary to prot ect patients and others (§ 418.110(c)(1)(ii)). However, this periodic rehearsal requirement doe s not ensure that hospices are performing any type of drill or exercise annually or that they are documenti ng their responses. In addition, there is no requirement in the current CoPs for outpatie nt hospices to have an emergency plan or for these hospices to test any emergency procedures they may currently have. We believe that developing the scenarios for these drills and exer cises and the documentation necessary to record the events during drills, exercises, and emerge ncy events would be new requirements for all hospices.176

The associated burden would be the time a nd effort necessary for a hospice to comply with these requirements. We expect that comp lying with these require ments would require the involvement of a registered nurse. We expect that the registered nurse would develop the necessary documentation and the scenarios for the drills and exercises. We estimate that these tasks would require 4 burden hours at an estimated cost of $168. Based on this estimate, in order for all 3,773 hospices to comply with these requirements, it would require 15,092 burden hours (4 burden hours for each hospice x 3,773 hospi ces = 15,092 burden hours) at a cost of $633,864 ($168 estimated cost for each hospice x 3,773 hospices = $633,864 estimated cost). Thus, for all 3,773 hospices to comply with al l of the requirements in § 418.113, it would require an estimated 193,041 burde n hours at a cost of $10,444,148.

TABLE 4: BURDEN HOURS AND COST ESTIMATES FOR ALL 3,773 HOSPICES TO COMPLY WITH THE ICRs IN §418.113 CONDITION: EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/Maintenance Costs ($) Total Cost ($) §418.113(a)(1) (inpatient) 0938- New 1,189 1,189 10 11,890 589,744 589,744 §418.113(a)(1) (outpatient) 0938- New 2,584 2,584 12 31,008 1,532,312 1,532,312 §418.113(a)(1)- (4) (inpatient) 0938- New 1,189 1,189 14 16,646 882,238 882,238 §418.113(a)(1)- (4) (outpatient) 0938- New 2,584 2,584 20 51,680 2,702,864 2,702,864 §418.113(b) (inpatient) 0938- New 1,189 1,189 8 9,512 474,411 474,411 §418.113(b) (outpatient) 0938- New 2,584 2,584 9 23,256 1,173,136 1,173,136 §418.113(c) 0938- New 3,773 3,773 3 11,319 622,545 622,545 §418.113(d)(1) 0938- New 3,773 3,773 6 22,638 950,796 950,796 §418.113(d)(2) 0938- New 3,773 3,773 4 15,092 633,864 633,864 Totals 3,773 22,638 193,041 10,444,148 **The hourly labor cost is blended between the wages for multiple staffing levels.177

F. ICRs Regarding Emergency Preparedness (§ 441.184) Proposed § 441.184(a) would re quire Psychiatric Resident ial Treatment Facilities (PRTFs) to develop and maintain emergency pr eparedness plans and review and update those plans at least annually. We propose that these plans meet the requirements listed at § 441.184(a)(1) through (4). Section § 441.184(a)(1) would require each PRTF to develop a documented, facility-based and community-based risk assessmen t that would utilize an all-hazards approach. We expect that all PRTFs have already performed some of the work needed for a risk assessment because it is standard practice for health care facilities to prepare for common hazards, such as fires and power outages, and disasters or emerge ncies common in their geographic area, such as snowstorms or hurricanes. However, many PRTFs may not have documented their risk assessments or performed one that would comp ly with all of our proposed requirements. Therefore, we expect that all PRTFs would ha ve to review and revise their current risk

assessments. We have not designated any specific process or format for PRTFs to use in conducting

their risk assessments because we believe that PRTFs need maximum flexibility to determine the best way to accomplish this task. However, we expect that PRTFs would include representation from or seek input from all of their major de partments. Based on our experience with PRTFs, we expect that conducting the ri sk assessment would require th e involvement of the PRTF’s administrator, a psychiatric regist ered nurse, and a clinical social worker. We expect that all of

these individuals would attend an initial meeting, review thei r current assessment, develop comments and recommendations for changes, attend a follow-up meeting, perform a final review, and approve the new risk assessment. We expect that the psychi atric registered nurse178

would coordinate the meetings, perform an initia l review, offer suggested revisions, coordinate comments, develop a new risk assessment, and ensu re that the necessary parties approve the new risk assessment. We also expect that the psyc hiatric registered nurse would spend more time reviewing and working on the risk assessment than the other individuals. We estimate that in order for each PRTF to comply, it would requ ire 8 burden hours at a cost of $394. There are currently 387 PRTFs. Therefore, based on that estimate, compliance by all PRTFs would require 3,096 burden hours (8 burden hours for each PRTF x 387 PRTFs = 3,096 burden hours) at a cost of $152,478 ($394 estimated cost for each PRTF x 387 PRTFs = $152,478 estimated cost). After conducting the risk assessment, § 441.184(a)(1) through (4) would require PRTFs to develop and maintain an emergency prepared ness plan. Although it is standard practice for health care facilities to have some type of emergency preparedness plan, all PRTFs would need to review their current plans and compare them to their risk assessments. Each PRTF would need to update, revise, and, in some cases, deve lop new sections to complete its emergency preparedness plan. Based upon our experience with PRTFs, we exp ect that the administ rator and psychiatric registered nurse who were involved in developi ng the risk assessment would be involved in developing the emergency preparedness plan. Howe ver, we expect it woul d require substantially more time to complete the plan than the risk a ssessment. We expect th at the psychiatric nurse would be the most heavily involved in revi ewing and developing the PRTF’s emergency preparedness plan. We also expect that a clini cal social worker would review the drafts of the plan and provide comments on it to the psychiatric registered nurse. We estimate that for each PRTF to comply with this requirement woul d require 12 burden hours at a cost of $634. Thus, we estimate that it would require 4,644 burde n hours (12 burden hours for each PRTF x 387179

PRTFs = 4,644 burden hours) for al l PRTFs to comply with this requirement at a cost of $245,358 ($634 estimated cost per PRTF x 387 PRTFs = $245,358 estimated cost). PRTFs also would be required to review and update their emergency preparedness plans at least annually. We believe that PRTFs ar e already reviewing thei r emergency preparedness plans periodically. Thus, compliance with th is requirement would constitute a usual and customary business practice for PRTFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 441.184(b) would require each PRTF to develop and implement emergency preparedness policies and procedures, based on thei r emergency plan set fort h in paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this se ction, and the communication plan at paragraph (c) of this section. We also propose requiring PRTFs to review and update these policies and procedures at least annually. At a minimum, we would require that the PRTF’s policies and procedures addr ess the requirements listed at § 441.184(b)(1) through (8). Since we expect that all PRTFs already ha ve some type of emergency plan, we also expect that all PRTFs have some emergency pr eparedness policies and procedures. However, we expect that all PRTFs would need to review their policies and procedures; compare them to their risk assessments, emergency preparedness plans, and communication plans they developed in accordance with § 441.183(a)(1), (a) and (c), respectively; and then revise their policies and procedures accordingly. We expect that the administrator and a psyc hiatric registered nurse would be involved in reviewing and revising the policies and procedur es and, if needed, developing new policies and procedures. We estimate that it would require 9 burden hours at a cost of $498 for each PRTF to comply with this requirement. Based on th is estimate, it would require 3,483 burden hours180

(9 burden hours for each PRTF x 387 PRTFs = 3,483 burden hours) for all PRTFs to comply with this requirement at a cost of $192,726 ($498 estimated cost per PRTF x 387 PRTFs = $192,726 estimated cost). We are also proposing that PRTFs review and update their emergency preparedness policies and procedures at least annually. We believe that PRTFs are already reviewing their emergency preparedness policies and procedures pe riodically. Therefore, compliance with this requirement would constitute a usual and cust omary business practice fo r PRTFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 441.184(c) would require each PRTF to develop and maintain an emergency preparedness communication plan that complied w ith both federal and state law. PRTFs also would have to review and update these plans at least annually. The communication plan would

have to include the information se t out in § 441.184(c)(1) through (7). We expect that all PRTFs have some t ype of emergency prep aredness communication plan. It is standard practice for health care facilities to maintain contact information for both staff

and outside sources of assistan ce; alternate means of communi cation in case there is an interruption in phone service to the facility; and a method for sh aring information and medical

documentation with other health ca re providers to ensure continu ity of care for their residents. However, most PRTFs may not have formal, written emergency preparedness communication plans. Therefore, we expect th at all PRTFs would need to revi ew and, if needed, revise their plans. Based on our experience with PRTFs, we anticipate that satisfying these requirements would require the involvement of the PRTF’s admi nistrator and a psychiatri c registered nurse to review, revise, and if needed, develop new s ections for the PRTF’s emergency preparedness181

communication plan. We estimate that for each PRTF to comply would require 5 burden hours at a cost of $286. Based on that estimate, for all PRTFs to comply would require 1,935 burden hours (5 burden hours for each PRTF x 387 PRTFs = 1,935 burden hours) at a cost of $110,682 ($286 estimated cost for each PRTF x 387 PRTFs = $110,682 estimated cost). PRTFs must also review and update thei r emergency preparedness communication plans at least annually. We believe that PRTFs ar e already reviewing thei r emergency preparedness communication plans periodically. Thus, complian ce with this requirement would constitute a usual and customary business practice for PRTF s and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 441.184(d) would require PRTFs to develop and maintain emergency preparedness training programs and review and update those programs at least annually. Proposed § 441.184(d)(1) would require PRTFs to provide initial training in emergency preparedness policies and procedur es to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The PRTF would al so have to ensure that their staff could demonstrate knowledge of the emergency procedur es. Thereafter, the PRTF would have to provide emergency preparedness training at least annually. Based on our experience with PRTFs, we e xpect that all PRTFs have some type of emergency preparedness training program. However, PRTFs would need to review their current training programs and compare them to their risk assessments and emergency preparedness plans, policies and procedures, and communication plans and update and, in some cases, develop new sections for their training programs.182

We expect that complying with this requi rement would require the involvement of a psychiatric registered nurse. We expect that the psychiatric registered nurse would review the PRTF’s current training program; determine what tasks would need to be performed and what materials would need to be developed; and devel op the necessary materials. We estimate that for each PRTF to comply with the requirements in this section would require 10 burden hours at a cost of $460. Based on this estimate, for all PRTFs to comply with this requirement would require 3,870 burden hours (10 burden hours fo r each PRTF x 387 PRTFs = 3,870 burden hours) at a cost of $178,020 ($460 estimated cost fo r each PRTF x 387 PRTFs = $178,020 estimated cost). PRTFs would also be required to revi ew and update their emergency preparedness training program at least annua lly. We believe that PRTFs are already reviewing their emergency preparedness training programs peri odically. Therefore, compliance with this requirement would constitute a usual and cust omary business practice fo r PRTFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 441.184(d)(2) would require PRTFs to participate in a community mock disaster drill, and if one were not available, c onduct an individual, facil ity-based mock disaster drill, and a paper-based, tabletop exercise at le ast annually. PRTFs would also have to analyze their responses to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise their emergency plans, as need ed. However, if a PRTF experienced an actual natural or man-made emergency that required acti vation of its emergency plan, that PRTF would be exempt from engaging in a community or an i ndividual, facility-based mock disaster drill for 1 year following the onset of the actual emergenc y event. To comply with this requirement,183

PRTFs would need to develop scenarios for each drill and exercise and the documentation necessary to record and analyze drills, exercises, and actual emergency events. Based on our experience with PRTFs, we e xpect that all PRTFs have some type of emergency preparedness testing program and most , if not all, PRTFs already conduct some type of drill or exercise to test their emergency preparedness plans. We also expect that they have already developed some type of documentation for drills, exercises, and emergency events. However, we do not expect that all PRTFs are conducting both a drill and a paper-based, tabletop exercise annually or have developed the appr opriate documentation. Thus, we will analyze the burden of these requirements for all PRTFs. Based on our experience with PRTFs, we exp ect that the same indi vidual who developed the emergency preparedness training program woul d develop the scenarios for the drill and the exercise and the accompanying documentation. We estimate that for each PRTF to comply with the requirements in this secti on would require 3 burden hours at a cost of $138. We estimate that for all PRTFs to comply would require 1,161 burden hours (3 burden hours for each PRTF x 387 PRTFs = 1,161 burden hours) at a cost of $53,406 ($138 estimated cost for each PRTF x 387 PRTFs = $53,406 estimated cost). Based on the previous analysis, for all 387 PRTFs to comply with the ICRs in this proposed rule would require 18,189 burden hours at a cost of $932,670.

TABLE 5: BURDEN HO URS AND COST ESTIMATE S FOR ALL 387 PRTFs TO COMPLY WITH THE ICRs CONTAINE D IN § 441.184 CONDITION: EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($)184

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §441.184(a)(1) 0938- New 387 387 8 3,096 ** 152,478 0 152,478 §441.184(a)(1)-(4) 0938- New 387 387 12 4,644 ** 245,358 0 245,358 §441.184(b) 0938- New 387 387 9 3,483 ** 192,726 0 192,726 §441.184(c) 0938- New 387 387 5 1,935 ** 110,682 0 110,682 §441.184(d)(1) 0938- New 387 387 10 3,870 ** 178,020 0 178,020 §441.184(d)(2) 0938- New 387 387 3 1,161 ** 53,406 0 53,406 Totals 387 2,322 18,189 932,670 G. ICRs Regarding Emer gency Preparedness (§ 460.84) Proposed § 460.84(a) would require the Progr am for the All-Inclusive Care for the Elderly (PACE) organizations to develop and maintain emergency preparedness plans and review and update those plans at least annually. We propose that each plan must meet the requirements listed at § 460.84(a)(1) through (4). Section § 460.84(a)(1) woul d require PACE organizati ons to develop documented, facility-based and community-based risk assessm ents utilizing an all- hazards approach. We believe that the performance of a risk assessment is a standard practice, and that all of the PACE organizations have already conducted some sort of risk assessment based on common emergencies the organization might encounter , such as fires, loss of power, loss of communications, etc. Therefore, we believe th at each PACE organization should have already performed some sort of risk assessment. Under the current regulations, PACE organiza tions are required to establish, implement, and maintain procedures for managing medical and non-medical emergencies and disasters that are likely to threaten the health or safety of the participants, sta ff, or the public (§ 460.72(c)(1)).185

The definition of "emergencies" in cludes natural disasters that ar e likely to occur in the PACE organization’s area (§ 460.72(c)(2 )). PACE organizations are re quired to plan for emergencies involving participants who are in their center(s) at the time of an emergency, as well as participants receiving services in their homes. For the purpose of determining the burden, we will assume that a PACE organization’s risk assessment, emergency plan, policies and procedures, communication plan, and training and testing program would apply to all of a PACE organization’s centers. Based on the existing PACE regulations, we expect that they already assess their physic al structure(s), the areas in which they are located, and the location(s) of thei r participants. However, these risk assessments may not be documented or address all of our proposed requirements. Therefore, we expect that all 91 PACE organizations would have to re view, revise, and update their current risk

assessments. We have not designated any sp ecific process or format for PACE organizations to use in conducting their risk assessments because we believ e that they would be able to determine the best way for their facilities to accomplish this tas k. However, we expect that they would include representation or input from all of their major de partments. Based on our experience with PACE organizations, we expect that conducting the ri sk assessment would require the involvement of the PACE organization’s program director, medi cal director, home care coordinator, quality improvement nurse, social worker, and a driver. We expect that these individuals would either attend an initial meeting or be as ked to individually review releva nt sections of the current risk assessment and prepare and forward their comments to the quality assurance nurse. After initial comments are received, some would attend a foll ow-up meeting, perform a final review, and ensure the new risk assessment was approved by the appropriate individuals. We expect that the186

quality improvement nurse would coordinate the meetings, review the current risk assessment, suggest revisions, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approve it. We expect that the quality improvement nurse and the home care coordinator would spend more tim e reviewing and developing the risk assessment than the other

individuals. We estimate that complying with the requi rement to conduct a risk assessment would require 14 burden hours at a cost of $761. For al l 91 PACE organizations to comply with this requirement would require an estimated 1,274 burden hours (14 burden hours for each PACE organization x 91 PACE organizations = 1,274 burden hours) at a cost of $69,251 ($761 estimated cost for each PACE organization x 91 PA CE organizations = $69,251 estimated cost). After conducting a risk assessment, PACE organizations would have to develop and maintain emergency preparedness plans that sati sfied all of the require ments in § 460.84(a)(1) through (4). In addition to the requirement to establish, implement, and maintain procedures for managing emergencies and disasters, current regul ations require PACE organizations to have a governing body or designated person responsible for developing policies on participant health and safety, including a comprehensive, systemic ope rational plan to ensure the health and safety of the PACE organization’s participants (§ 460.62(a)(6)). We expect that an emergency preparedness plan would be an essential component of such a comprehensive, systemic operational plan. However, this regulatory requirement does not guarantee that all PACE organizations have developed a plan that complies with our proposed requirements. Thus, we expect that all PA CE organizations would need to review their current plans and compare them to their risk assessments. PACE organizations would need to update, revise, and, in some cases, develop new sections to co mplete their emergency preparedness plans.187

Based upon our experience with PACE orga nizations, we expect that the same

individuals who were involved in developing the risk assess ment would be involved in developing the emergency preparedness plan. Howe ver, we expect that it would require more time to complete the plan. We expect that th e quality improvement nurse would have primary responsibility for reviewing and developing th e PACE organization’s emergency preparedness plan. We expect that the program director, home care coordinator, and social worker would review the current plan, provide comments, and assist the quality improvement nurse in developing the final plan. Other staff members would work only on th e sections of the plan that

would be relevant to thei r areas of responsibility. We estimate that for each PACE organizati on to comply with the requirement for an emergency preparedness plan would require 23 burden hours at a cost of $1,239. We estimate that for all PACE organizations to comply would require 2,093 burden hours (23 burden hours for each PACE Organization x 91 PACE organi zations = 2,093 burden hours) at a cost of $112,749 ($1,239 estimated cost for each PACE or ganization x 91 PACE organizations = $112,749 estimated cost). PACE organizations would also be requi red to review and update their emergency preparedness plans at least annually. We believe that PACE organizations are already reviewing their emergency preparedness plan s periodically. Therefore, co mpliance with this requirement would constitute a usual and customary business practice for PACE organi zations and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 460.84(b) would require each PACE organization to develop and implement emergency preparedness policies and procedures based on the emergency plan set forth in paragraph (a) of this section, th e risk assessment at paragraph (a)(1) of this section, and the188

communication plan at (c) of this section. It w ould also require PACE or ganizations to review and update these policies and proced ures at least annually. At a mi nimum, we would require that a PACE organization’s policies a nd procedures address the requirements list ed at § 460.84(b)(1) through (9). Current regulations already require that PA CE organizations establish, implement, and maintain procedures for managing emergencies and disasters (§ 460.72(c)). The definition of "emergencies" includes medical and nonmedical emer gencies, such as natural disasters likely to occur in a PACE organization’s area (42 CFR 460.72(c)(2)). In addition, all PACE organizations must have a governing body or a de signated person who functions as the governing body responsible for developing policies on particip ant health and safety (§ 460.62(a)(6)). Thus, we expect that all PACE organizations have some emergency preparedness policies and procedures. However, these requirements do no t ensure that all PACE organizations have policies and procedures that would comp ly with our proposed requirements. The burden associated with the proposed requi rements would be the resources needed to review, revise, and, if needed, develop new em ergency preparedness policies and procedures. We expect that the program di rector, home care coordinator, and quality improvement nurse would be primarily responsible for reviewi ng, revising, and if need ed, developing any new policies and procedures needed to comply with our proposed require ments. We estimate that for each PACE organization to comply with our proposed requirements would require 12 burden hours at a cost of $598. Therefore, based on this estimate, for all PACE organizations to comply would require 1,092 burden hours (12 burden hour s for each PACE organization x 91 PACE organizations = 1,092 burden hours) at a cost of $54,418 ($598 estimated cost for each PACE organization x 91 PACE organizatio ns = $54,418 estimated cost).189

We propose that each PACE organization mu st also review and update its emergency preparedness policies and procedur es at least annually. We believe that PACE organizations are already reviewing their emergenc y preparedness policies and proc edures periodically. Thus, compliance with this requirement would constitu te a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 460.84(c) would require each PACE organization to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. Each PACE organization would also have to revi ew and update this plan at least annually. The communication plan must include the inform ation set out at § 460.84(c)(1) through (7). All PACE organizations must have a governing body (or a designated person who functions as the governing body) th at is responsible for developi ng policies on participant health and safety, including a comprehensive, systemic ope rational plan to ensure the health and safety of the PACE organization’s participants (§ 460.62(a)(6)). We e xpect that the PACE organizations’ comprehensive, systemic operationa l plans would include at least some of our proposed requirements. In additi on, it is standard practice in the health care industry to maintain

contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the fa cility; and a method for sharing information and medical documentation w ith other health care providers to ensure continuity of care for patients. Thus, we expect that all PACE organizati ons have some type of emergency preparedness communication plan. However, each PACE organization would need to review its current plan and revise or, in some cases, develop new sections to comply with our proposed requirements.190

Based on our experience with PACE orga nizations, we expect that the home care coordinator and the quality assurance nurse would be primaril y responsible for reviewing, and if needed, revising, and developing new sections for the communication plan. We estimate that for each PACE organization to comply with the pr oposed requirements would require 7 burden hours at a cost of $315. Therefore, based on this estimate, for all PACE organizations to comply with this requirement woul d require 637 burden hours (7 burden hours for each PACE organization x 91 PACE organizations = 637 bur den hours) at a cost of $28,665 ($315 estimated cost for each PACE organization x 91 PACE organizations = $28,665 estimated cost). Each PACE organization must also revi ew and update its emergency preparedness communication plan at least annually. We be lieve that PACE organizations are already reviewing and updating their emergency prepare dness communication plans periodically. Thus, compliance with this requirement would constitu te a usual and customary business practice for PACE organizations and would not be subj ect to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 460.84(d) would require PACE or ganizations to develop and maintain emergency preparedness training and testing programs and review and update those programs at least annually. We propose that each PACE organization would ha ve to meet the requirements listed at § 460.84(d)(1) and (2). Proposed § 460.84(d)(1) would require PACE or ganizations to provide initial training on their emergency preparedness policies and procedur es to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expect ed roles and maintain documen tation of this training. PACE organizations would also have to ensure that their staff could demonstrate knowledge of the191

emergency procedures. Thereafter, PACE organi zations would be required to provide this training annually. Current regulations require PACE organiza tions to provide peri odic orientation and appropriate training to their sta ffs and participants in emerge ncy procedures (§ 460.72(c)(3)). However, these requirements do not ensure that all PACE organizations would be in compliance with our proposed requirements. Thus, each PACE organization would need to review its current training program and compare the training program to its risk assessment, emergency preparedness plan, policies and procedures, a nd communication plan. The PACE organization would also need to revise and, in some cases, de velop new sections to en sure that its emergency preparedness training program complied with our proposed requirements. We expect that the quality assurance nurse would review all elemen ts of the PACE organi zation’s training program and determine what tasks would need to be pe rformed and what materials would need to be developed to comply with our proposed requirement s. We expect that the home care coordinator would work with the quality assurance nurse to develop the revised and updated training program. We estimate that for each PACE organization to comply with the proposed requirements would require 12 bur den hours at a cost of $540. Th erefore, it would require an estimated 1,092 burden hours (12 burden hours for each PACE organization x 91 PACE organizations = 1,092 burden hours) to comply wi th this requirement at a cost of $49,140 ($540 estimated cost for each PACE organization x 91 PA CE organizations = $49,140 estimated cost). PACE organizations would also be requi red to review and update their emergency preparedness training program at least annuall y. We believe that PA CE organizations are already reviewing and updating their emergency preparedness training programs periodically. Therefore, compliance with this requirement w ould constitute a usual and customary business192

practice for PACE organizations and would not be subject to th e PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 460.84(d)(2) would require PACE organizations to participate in a community mock disaster drill at least annually. If a community mock disaster drill was not available, the PACE organization would have to conduct an individual, facility-based mock disaster drill. They would also be required to conduct a paper-based, ta bletop exercise at least annually. PACE organizations would also be required to analyze their responses to, and maintain documentation of, all drills, exercises, a nd any emergency events they experienced. If a PACE organization experienced an actual na tural or man-made emergency that required activation of its emergency plan, it would be exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year follo wing the onset of the actual event. To comply with these requireme nts, PACE organizations would need to develop a specific

scenario for each drill and exerci se. The PACE organizations would also have to develop the documentation necessary for recording and analyzi ng their response to all drills, exercises, and

emergency events. Current regulations require each PACE organi zation to conduct a test of its emergency and disaster plan at least a nnually (42 CFR 460.72(c)(5)). Th ey also must evaluate and document the effectiveness of their emergency a nd disaster plans. Thus, PACE organizations already conduct at least one test an nually of their plans. We expect that as part of testing their emergency plans annually, PACE organizations would develop a scenario for and document the testing. However, this does not ensure that all PACE organizations would be in compliance with all of our proposed requirements , especially the pr oposed requirement for conducting a paper-193

based, tabletop exercise; performing a community-bas ed mock disaster drill; and using different

scenarios for the drill and the exercise. The 91 PACE organizations would be required to develop scenarios for a mock disaster drill and a paper-based, tabletop exercise and th e documentation necessary to record and analyze their response to all drills, exer cises, and any emergency events. Based on our experience with PACE organizations, we expect that the same individuals who developed their emergency preparedness training programs would develop the required documentation. We expect the quality improvement nurse would spend more time on these activities than the health care

coordinator. We estimate that this activit y would require 5 burden hours for each PACE organization at a cost of $225. We estimate that for all PACE organizations to comply with these requirements would require 455 burden hour s (5 burden hours for each PACE organization x 91 PACE organizations = 455 burden hours) at a cost of $20,475 ($225 estimated cost for each PACE organization x 91 PACE orga nizations = $20,475 estimated cost).

TABLE 6: BURDEN HOURS AND CO ST ESTIMATES FOR ALL 91 PACE ORGANIZATIONS TO COMPLY WITH THE ICRs CONTAINED IN § 460.84 EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §460.84(a)(1) 0938- New 91 91 14 1,274 ** 69,251 0 69,251 §460.84(a)(1)-(4) 0938- New 91 91 23 2,093 ** 112,749 0 112,749 §460.84(b) 0938- New 91 91 12 1,092 ** 54,418 0 54,418 §460.84(c) 0938- New 91 91 7 637 ** 28,665 0 28,665 §460.84(d)(1) 0938- New 91 91 12 1,092 ** 49,140 0 49,140 §460.84(d)(2) 0938- New 91 91 5 455 ** 20,475 0 20,475 Totals 91 546 6,643 334,698194

**The hourly labor cost is blended between the wages for multiple staffing levels. H. ICRs Regarding Condition of Partic ipation: Emergency Preparedness (§ 482.15) Proposed § 482.15(a) would require hospitals to develop and maintain emergency preparedness plans. We propose that hospitals be required to review a nd update their emergency preparedness plans at least annually and meet the requirements set out at § 482.15(a)(1) through (4).

Note that we obtain data on the number of hospitals, both accred ited and non-accredited, from the CMS CASPER data system, which are upda ted periodically by th e individual states.

Due to variations in the timeliness of the data submissions, all numbers are approximate, and the number of accredited and non-accredited hospitals shown may not equal the number of hospitals at the time of this proposed rule ’s publication. In a ddition, some hospitals may have chosen to be accredited by more than one accrediting organization. There are approximately 4,928 Medicare-certif ied hospitals. This includes 107 critical access hospitals (CAHs) that have re habilitation or psychiatric distin ct part units (DPUs) as of March 27, 2013. The services provided by CAH psyc hiatric or rehabilitation DPUs must comply with the hospital Conditions of Participation (CoPs) (42 CF R 485.647(a)). RNHCIs and CAHs

that do not have DPUs have been excluded from th is number and are addressed separately in this analysis. Of the 4,928 hospitals reported in CMS’ CASPER da ta system, approximately 4,587 are accredited hospitals and the remainder is non -accredited hospitals. Three organizations have accrediting authority for these hospitals: TJC, formerly known as the Joint Commission on the Accreditation of Healthcare Organi zations (JCAHO), the AOA, and DNVHC.

Accreditation can substantia lly affect the burden a hospi tal would sustain under this proposed rule. The Joint Commission accredits 3,410 hospitals. Many of our proposed requirements are similar or virtua lly identical to the standards, rationales, and elements of195

performance (EPs) required for TJC accreditation. The TJC standards, rationales, and elements of performance (EPs) are on the TJC website at http://www.jointcommission.org/

. The other two accrediting organiza tions, AOA and DNVHC, accredit 185 and 176 hospitals, respectively. The AOA hospital acc reditation requirements do not emphasize emergency preparedness. In addition, these hospitals account for less than 5 percent of all of the hospitals. Thus, for purposes of determining the burden, we have included the 185 AOA-accredited hospitals and the 176 DNVHC-accredited hospitals in with the hospitals that are not accredited. Therefore, unless indicate d otherwise, we have analyzed the burden for the 3,410 TJC-accredited hospitals separately from the remaining 1,518 non TJC-accredited hospitals (4,928 hospitals – 3,410 TJC-accr edited hospitals = 1,518 non TJC-accredited hospitals). We have used TJC’s "Comprehensive Accred itation Manual for Hospitals: The Official Handbook 2008 (CAMH)" to determine the burden for TJC-accredited hospitals . In the chapter entitled, "Management of the Envi ronment of Care" (EC), hospita ls are required to plan for managing the consequences of emergencies (C AMH, Standard EC.4.11, CAMH Refreshed Core, January 2008, p. EC-13a). Individual standard s have EPs, which provide the detailed and specific performance expectations, structures, and processes for each standard (CAMH, CAMH Refreshed Core, January 2008, p. HM-6). The EPs for Standard EC.4.11 require, among other things, that hospitals conduct a hazard vulnera bility analysis (HVA) (CAMH, Standard EC.4.11, EP 2, CAMH Refreshed Core, January 2008, p. EC -13a). Performing an HVA would require a hospital to identify the events that could possibly affect demand for the hospital’s services or the hospital’s ability to provide se rvices. A TJC-accredited hospital also must determine the

likeliness of the iden tified risks occurring, as well as their consequences. Thus, we expect that196

TJC-accredited hospitals alrea dy conduct an HVA that complies with our proposed requirements and that any additional tasks necessary to comp ly would be minimal. Therefore, for TJCaccredited hospitals, the risk assessment requirement would constitute a usual and customary business practice and would not be subject to th e PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 482.15(a)(1) would require that hospitals perform a documented, facilitybased and community-based risk assessment, utiliz ing an all-hazards approa ch. We expect that most non TJC-accredited hospitals have already perf ormed at least some of the work needed for

a risk assessment. The Niska and Burt article in dicated that most hospitals already have plans for natural disasters. However, many may not have thoroughly documented this activity or performed as thorough a risk assessment as needed to comply with our proposed requirements. We have not designated any specific process or format for hospitals to use in conducting a risk assessment because we believe that hospitals need the flexibility to determine how best to accomplish this task. However, we expect that hospitals would obtain input from all of their major departments when performing a risk assessment. Based on our experience, we expect that conducting a risk assessment would require the involvement of at least a hospital administrator, the risk management director, the chief medical officer, the chief of surgery, the director of nursing, the pharmacy director, the fa cilities director, the health in formation services director, the safety director, the security manager, the co mmunity relations manager, the food services director, and administrative support staff. We exp ect that most of these individuals would attend an initial meeting, review relevant sections of their current risk assessment, prepare and send their comments to the risk management direct or, attend a follow-up meeting, perform a final review, and approve the new risk assessment.197

We expect that the risk management direct or would coordinate th e meetings, review and comment on the current risk assessment, suggest revisions, coordinate comments, develop the new risk assessment, and ensure that the necessa ry parties approve it. We expect that the hospital administrator would spe nd more time reviewing the risk assessment than most of the

other individuals.

We estimate that the risk assessment would require 36 burden hours to complete at a cost of $2,923 for each non-TJC accredited hospita l. There are approximately 1,518 non TJC-accredited hospitals. Therefore, it woul d require an estimated 54,648 burden hours (36 burden hours for each non TJC-accredited hosp itals x 1,518 non TJC-accredited hospitals = 54,648 burden hours) for all non TJC-accredited hos pitals to comply at a cost of $4,437,114 ($2,923 estimated cost for each non TJC-hospital x 1,518 non TJC-accredited hospitals = $4,437,114 estimated cost). Proposed § 482.15(a)(1) through (4) would requi re hospitals to develop and maintain emergency preparedness plans. We expect that all hospitals would compare their risk assessments to their emergency plans and revise and, if necessary, develop new sections for their plans. TJC-accredited hospitals must develop an d maintain written Emergency Operations Plans (EOPs) (CAMH, Standard EC.4.12, EP 1, CAMH Refreshed Care, January 2008, p. EC-13b). The EOP should describe an "all-hazards" ap proach to coordinating six critical areas: communications, resources and assets, safety a nd security, staff roles and responsibilities, utilities, and patient clinical and support activities during emergenc ies (CAMH, Standard EC.4.13 – EC.4.18, CAMH Refreshed Core, January 2008, pp. EC-13b – EC-13g). Hospitals also must include in their EOP "[r]esponse strate gies and actions to be activated during the emergency" and "[r]ecovery strategies and actions designed to help restor e the systems that are198

critical to resuming normal care, treatment a nd services" (CAMH, Standard EC.4.11, EPs 7 and 8, p. EC-13a). In addition, hospitals are required to have plans to manage "clinical services for vulnerable populations served by the hospital, in cluding patients who are pediatric, geriatric,

disabled or have serious chr onic conditions or addictions" (CAMH, Standard EC.4.18, EP 2, p. EC-13g). Hospitals also must plan how to mana ge the mental health needs of their patients (CAMH, Standard EC.4.18, EP 4, EC-13g). Thus, we expect that TJC-accredited hospitals have already developed and are maintaining EOPs that comply with the requirement for an emergency plan in this proposed rule. If a TJC-accredited hospital needed to complete additional tasks to comply with the proposed requirement, we beli eve that the burden would be negligible. Therefore, for TJC-accredited hospitals, this re quirement would constitute a usual and customary business practice and would not be subject to th e PRA in accordance with 5 CFR 1320.3(b)(2). We expect that most, if not all, non TJC-accr edited hospitals already have some type of emergency preparedness plan. The Niska and Burt article noted that the majority of hospitals have plans for natural disasters; incendiary incidents; and biological, chemical, and radiological terrorism. In addition, all hospi tals must already meet the re quirements set out at 42 CFR 482.41, including emergency power, lighting, gas a nd water supply requirements as well as specified Life Safety Code provisions. However, those existing plans may not be fully compliant with our proposed requirements. Thus, it would be necessary for non TJC-accredited hospitals to review their current plans and co mpare them to their risk assessments and revise, update, or, in some cases, develop new sections for their emergency plans. Based on our experience with hospitals, we expect that the same individuals who were involved in developing the risk assessment would be involved in developing the emergency preparedness plan. However, we estimate th at it would require subs tantially more time to199

complete an emergency preparedness plan. We estimate that complying with this requirement would require 62 burden hours at a cost of $5,085 for each non TJC-accredited hospital. There are approximately 1,518 non TJC-accredited hospitals . Therefore, based on this estimate, it would require 94,116 burden hours for all non TJ C-accredited hospitals (62 burden hours for each non TJC-accredited hospitals x 1,518 non TJC- accredited hospitals = 94,116 burden hours) to complete an emergency preparedness plan at a cost of $7,719,030 ($5,085 estimated cost for each non TJC-accredited hospital x 1,518 non TJ C-accredited hospitals = $7,719,030 estimated cost). Under this proposed rule, a hospital also would be required to review and update its emergency preparedness plan at least annually. We believe that hospitals already review their emergency preparedness plans periodically. Ther efore, compliance with this requirement would constitute a usual and customary business practice for hospitals a nd would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Under proposed § 482.15(b), we would require each hospital to develop and implement emergency preparedness policies and procedures based on its emergency plan set forth in paragraph (a) of this section, th e risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c ) of this section. We would also require hospitals to review and update these policies and proced ures at least annually. At a mi nimum, we would require that the policies and procedures address the requirements at § 482.15(b)(1) through (8). We would expect all hospita ls to review their emerge ncy preparedness policies and procedures and compare them to their emerge ncy plans, risk assessments, and communication plans. We expect that hospitals would then review, revise, and, if necessary, develop new policies and procedures that comply with our proposed requirements.200

The CAMH’s chapter entitled, "Leadership" (LD), requires TJC-accredited hospital leaders to "develop policies and pr ocedures that guide and suppor t patient care, treatment, and services" (CAMH, Standard LC.3.90, EP 1, CA MH Refreshed Core, January 2008, p. LD-15). Thus, we expect that TJC-accredited hospitals alr eady have some policies and procedures related to our proposed requirements. As discussed later, many of the requi rements in proposed § 482.15(b) has a corresponding requirement in the TJ C hospital accreditation standards. Hence, we will discuss each proposed section individually. Proposed § 482.15(b)(1) would require hospitals to have policies and procedures for the provision of subsistence needs for staff and patients, whether they evacuate or shelter in place. TJC-accredited hospitals are required to make plans for obtaining and replenishing medical and non-medical supplies, including food , water, and fuel for generato rs and transportation vehicles (CAMH, Standard EC.4.14, EPs 1-8 and 10-11, p. EC -13d). In addition, hospitals must identify alternative means of providing elec tricity, water, fuel, and other essential utility needs in cases when their usual supply is disrupted or co mpromised (CAMH, Standard EC.4.17, EPs 1-5, p. EC-13f). Thus, we expect that TJC-accredite d hospitals would be in compliance with our proposed provision of subsistence requi rements in proposed § 482.15(b)(1). Proposed § 482.15(b)(2) would require hospitals to have policies and procedures to track the location of staff and patients in the hospital’s care both during and after an emergency. TJCaccredited hospitals must plan for communicatin g with patients and their families at the beginning of and during an emergency (CAMH, Standard EC.4.13, EPs 1, 2, and 5, p. EC-13c). We expect that TJC-accredited hospitals would be in compliance with proposed §482.15(b)(2). Proposed § 482.15(b)(3) would require hospitals to have policies and procedures for a plan for the safe evacuation from the hospital. TJC-accredited hospitals are required to make201

plans to evacuate patients as part of managing their clinical activities (CAMH, Standard EC.4.18, EP 1, p. EC-13g). They also must plan for the evacuation and transport of patients, as well as their information, medications, supplies, and equipm ent, to alternative care sites (ACSs) when the hospital cannot provide care, treatment, and services in thei r facility (CAMH, Standard EC.4.14, EPs 9-11, p. EC-13d). Proposed § 482.15(b)(3 ) also would require hospitals to have "primary and alternate means of communication with external sources of assistance." TJCaccredited hospitals must plan for communicating with external authorities once the hospital initiates its emergency response measures (CAM H, Standard EC.4.13, EP 4, p. EC-13c). Thus, TJC-accredited hospitals would be in compliance with most of the requirements in proposed § 482.15(b)(3). However, we do not believe thes e requirements would ensure compliance with the proposed requirement that the hospital es tablish policies and procedures for staff responsibilities. Proposed § 482.15(b)(4) would require hospitals to have policies and procedures that address a means to shelter in place for patients, st aff, and volunteers who remain at the facility. The rationale for CAMH Standard EC.4.18 states, "a catastrophic emergency may result in the decision to keep all patients on the premises in the interest of safety" (CAMH, Standard EC.4.18, p. EC-13f). We expect that TJC-accredited hosp itals would be in comp liance with our proposed shelter in place requirement in §482.15(b)(4). Proposed § 482.15(b)(5) would require hospitals to have policies and procedures that address a system of medical do cumentation that preserves patie nt information, protects the confidentiality of patient information, and ensures that records are secure and readily available. The CAMH chapter entitled "Management of Info rmation" requires TJC-accredited hospitals to have storage and retrieval systems for their clinical/service and hospital-specific information202

(CAMH, Standard IM.3.10, EP 5, CAMH Refres hed Core, January 2008, p. IM-10) and to ensure the continuity of their critical information "needs for patie nt care, treatment, and services (CAMH, Standard IM.2.30, Rationale for IM.2.3 0, CAMH Refreshed Core, January 2008, p. IM8). They also must ensure the privacy and confidentiality of patient information (CAMH, Standard IM.2.10, CAMH Refreshed Core, January 2008, p. IM-7) and have plans for transporting and tracking patient s’ clinical information, includ ing transferring information to ACSs (CAMH Standard EC.4.14, EP 11, p. EC- 13d and Standard EC.4.18, EP 6, pp. EC-13d and EC-13g, respectively). Therefore, we expect that TJC-accredited hos pitals would be in compliance with the requirements we propose in § 482.15(b)(5). Proposed § 482.15(b)(6) would require hospitals to have policies and procedures that

address the use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of state and federally-designated health care professionals to address surge needs during an emergency. TJC-a ccredited hospitals must already define staff roles and responsibilities in their EOPs and ensure that they train their staffs for their assigned roles (CAMH, Standard EC.4.16, EPs 1 and 2, p. EC -13e). The rationale for Standard EC.4.15 indicates that the "hospital determines the type of access and movement to be allowed by . . . emergency volunteers . . . when emergency measures are initiated." In addition, in the chapter entitled "Medical Staff" (MS), hospitals "may gr ant disaster privileges to volunteers that are eligible to be licensed independent pract itioners" (CAMH, Standard MS.4.110, CAMH Refreshed Care, January 2008, p. MS-27). Finall y, in the chapter enti tled "Management of Human Resources" (HR), hospita ls "may assign disaster re sponsibilities to volunteer practitioners" (CAMH, Standard HR.1.25, CAMH Refreshed Core, January 2008, p. HR-5). Although TJC accreditation requirements partially address our proposed requirements, we do not203

believe these requirements would ensure comp liance with all requirements in proposed in § 482.15(b)(6). Proposed § 482.15(b)(7) would require hospitals to have policies and procedures that would address the development of arrangements with other hospitals or other providers to receive patients in the event of limitations or cessation of operations to ensure continuity of services to hospital patients. TJC-accredited hosp itals must plan for the sharing of resources and

assets with other health care organizations (CAMH, Standa rd EC.4.14, EPs 7 and 8, p. EC-13d). However, we would not expect TJC-accredited hosp itals to be substantially in compliance with the requirements we propose in § 482.15(b)(7 ) based on compliance with TJC accreditation

standards alone. Proposed § 482.15(b)(8) would require hospitals to have policies and procedures that address the hospital’s role under an "1135 waiver" (that is, a wa iver of some federal rules pursuant to §1135 of the Social Secu rity Act) in the provision of care and treatment at an ACS identified by emergency management officials. TJC-accredited hospitals must already have plans for transporting patients, as well as their associated information, medications, equipment, and staff to ACSs when the hospital cannot suppor t their care, treatment, and services on site (CAMH, Standard EC.4.14, EPs 10 and 11, p. EC-13d). We expect that TJC-accredited hospitals would be in compliance with the requirements we propose in § 482.15(b)(8). In summary, we expect that TJC-accredited hospitals have develope d and are maintaining policies and procedures that would comply with the requirements in proposed § 482.15(b), except for proposed §§ 482.15(b)(3), (6), and (7). Later we will discuss the burden on TJCaccredited hospitals with respect to these provisions. We expect th at any modifications that TJCaccredited hospitals would need to make to comply with the remaining proposed requirements204

would not impose a burden above th at incurred as part of usual and customary business practices. Thus, with the exception of the proposed requi rements set out at § 482.15(b)(3), (b)(6), and (b)(7), the proposed requirements would constitu te usual and customary business practices and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). The burden associated with proposed § 482.15( b)(3), (b)(6), and (b)(7) would be the resources required to develop wr itten policies and procedures th at comply with the proposed requirements. We expect that the risk manageme nt director would review the hospital’s policies and procedures initially and make recommendations for revisions and development of additional policies or procedures. We expect that repres entatives from the hospital’s major departments would make revisions or draft new policies and procedures based on the administrator’s recommendation. The appropriate parties would th en need to compile and disseminate these new policies and procedures. We estimate that complying with these re quirements would require 17 burden hours for each TJC-accredited hospital at a cost of $1,423. For all 3,410 TJC-accredited hospitals to comply with these requirements would require an estimated 57,970 burden hours (17 burden hours for each TJC-accredited hospital x 3,410 TJC-accredited hospitals = 57,970 burden hours) at a cost of $4,852,430 (1,423 estimated cost fo r each TJC-accredite d hospital x 3,410 TJCaccredited hospitals = $4,852,430 estimated cost). The 1,518 non TJC-accredited hospitals would need to review their policies and procedures, ensure that their po licies and procedures accurately reflect their risk assessments, emergency preparedness plans, and communicati on plans, and incorporate any of our proposed requirements into their policies and procedures. We expect that the risk management director would coordinate the meetings , review and comment on the cu rrent policies and procedures,205

suggest revisions, coordinate comm ents, develop the policies and pr ocedures, and ensure that the necessary parties approve it. We expect that the hospital administrato r would spend more time reviewing the policie s and procedures than most of the other individuals. We estimate that complying with this requirement would require 33 burden hours for each non TJC-accredited hospital at an estimated co st of $2,623. Based on this estimate, for all 1,518 non TJC-accredited hospitals to comply wi th these requirements would require 50,094 burden hours (33 burden hours for each non TJC-accredited hospital x 1,518 non TJC-accredited hospitals = 50,094 burden hours) at a cost of $3,981,714 ($2,623 estimated cost for each non TJC-accredited hospital x 1,518 non TJC-accredited hospitals = $3,981,714 estimated cost). In addition, we expect that there woul d be a burden as a result of proposed § 482.15(b)(7). Proposed § 482.15(b)(7) would requi re hospitals to develop and maintain policies and procedures that address a hospita l’s development of arrangements with other hospitals and other providers to receive patients in the event of limitations or cessation of operations to ensure continuity of services to hos pital patients. We expect that hospitals would base those arrangements on written agreements between the hospital and other hospitals and other providers. Thus, in addition to the burden related to developing the policies and procedures, hospitals would also sustain a burden related to de veloping the written agreements related to those arrangements. All 4,928 hospitals would need to identify other hos pitals and other providers with which they could have agreements, negotiate and dr aft the agreements, and obtain all necessary authorizations for the agreements. For the purpo se of determining the burden, we will assume that hospitals would have writte n agreements with two other hosp itals and other providers. Based on our experience with hospitals, we expect th at complying with this requirement would206

primarily require the involvement of the hospital’ s administrator and risk management director. We also expect that a hospital attorney would as sist with drafting the agreements and reviewing those documents for any legal implications. We estimate that complying with this requirement would require 8 burden hours for each hospital at an estimated cost of $719. Thus, it would require an estimated 39,424 burden hours (8 bur den hours for each hospital x 4,928 hospitals = 39,512 burden hours) for all hospitals to comply with this requirement at a cost of $3,543,232 ($719 estimated cost for each hospital x 4,928 hospitals = $3,543,232 estimated cost). Based upon the previous estimates, for all hosp itals to be in compliance with all of the requirements in § 482.15(b) it would re quire 147,488 burden hours at a cost of $12,377,376. Proposed § 482.15(b) would also require hospitals to review and update their emergency preparedness policies and procedures at leas t annually. We believe hospitals are already reviewing and updating their emergency prepare dness policies and procedures periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for both TJC-accredited and non TJC-accred ited hospitals and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 482.15(c) would require each hospita l to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. The plan would have to be reviewed and updated at least annu ally. The communication plan would have to

include the information listed at § 482.15(c)(1) through (7). We expect that all hospitals currently have some type of emergency preparedness communication plan. We expect that under this proposed rule, hospitals would review their current communication plans, compare them to their emergency preparedness plans and emergency policies and procedures, and revise their communication plans, as necessary.207

It is standard practice for h ealth care facilities to maintain contact information for staff

and outside sources of assistan ce; have alternate means of co mmunication in case there is an interruption in phone service to the facility; and have a met hod for sharing information and

medical documentation with other h ealth care providers to ensure c ontinuity of care for patients. However, under this proposed rule , all hospitals would need to review and update their plans to ensure compliance with our proposed requirements. The TJC-accredited hospitals are requi red to establish emergency communication strategies (CAMH, Standard EC.4.13, p. EC-13b). In addition, TJC-accredited hospitals are specifically required to ensure communication with st aff, external authoritie s, patients, and their families (CAMH, Standard EC.4.13, EPs 1-5, p. EC-13c). TJC-accredited hospitals also are required to establish "back-up communications systems and technologies" for such activities (CAMH, Standard EC.4.13, EP 14, p. EC-13c). Moreover, TJC-accredited hospitals are required specifically to define "the circ umstances and plans for communicat ing information about patients to third parties (such as other health care or ganizations) . . ." (CAMH, Standard EC.4.13, EP 12, p. EC-13c). Thus, we expect that that TJC-acc redited hospitals would be in compliance with proposed § 482.15(c)(1) through (c)(4). In addi tion, the rationale fo r EC.4.13 states, "the hospital maintains reliable surveillance and comm unications capability to detect emergencies and communicate response efforts to hospital response personnel, patient and their families, and external agencies (CAMH, Standard EC.4.13, pp. EC -13b – 13c). We expect that most, if not all, TJC-accredited hospitals would be in compliance with proposed § 482.15(c)(5) through (c)(7). Therefore, we expect that TJC-accredited hospitals already have developed and are currently maintaining emergenc y communication plans that would satisfy the requirements contained in proposed § 482.15(c) . Therefore, compliance w ith this requirement would208

constitute a usual and customary business pr actice and would not be subject to PRA in accordance with 5 CFR 1320.3(b)(2). Most, if not all, non TJC-accre dited hospitals would be subs tantially in compliance with proposed § 482.15(c)(1) through (c)(4). Neverthele ss, non TJC-accredited hospitals would need to review, update, and in some cases, develop new sections for their emergency communication plans to ensure they are in compliance with a ll of the proposed requireme nts in this subsection. We expect that this activity w ould require the involvement of th e hospital’s administrator, the risk management director, the facilities director , the health information services director, the security manager, and administrative support sta ff. We estimate that complying with this requirement would require 10 burden hours ata cost of $757 for each of the 1,518 non TJCaccredited hospitals. Therefore, based on this estimate, for non TJC-accredited hospitals to comply with this requirement would require 15,180 burden hours (10 burden hours for each non TJC-accredited hospital x 1,518 non TJC-accredited hospitals =15,180 burden hours) at a cost of $1,149,126 ($757 estimated cost for each non TJC-accredited hospital x 1,518 non TJC-accredited hospitals = $1,149,126 estimated cost). Proposed § 482.15(c) also would require hospita ls to review and update their emergency preparedness communication plans at least annua lly. We believe that hospitals are already reviewing and updating their emergency prep aredness communication plans periodically. Therefore, compliance with this requirement w ould constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 482.15(d) would require hospitals to develop and maintain emergency preparedness training and testing programs and re view and update those plans at least annually. The hospital would be required to meet the requirements in § 482.15(d)(1) and (2).209

Proposed § 482.15(d)(1) would require hospitals to provide initial and thereafter annual training on their emergency preparedness policies a nd procedures to all and new existing staff, individuals providing services under arrangement, and volunteers, c onsistent with their expected roles. Hospitals must also maintain documentation of all of this training. The burden for proposed § 482.15(d)(1) would be the time and effort necessary to develop a training program and the materials needed for the required initia l and annual training. We expect that all hospitals would review thei r current training programs and compare them to their risk assessments, emergency plans, polic ies and procedures, and communication plans as set forth in § 482.15(a)(1), (a), (b), and (c), resp ectively. Hospitals would need to revise and, if necessary, develop new sections or material to ensure that thei r training programs comply with our proposed requirements. The TJC-accredited hospitals ar e required to define staff roles and responsibilities in their EOP and train their staff for their assigned ro les during emergencies (CAMH, EC.4.16, EPs 1-2, p. EC-13e). In addition, the TJC-accredited hos pitals are required to provide an initial orientation, which includes information that th e hospital has determined are key elements the staff need before they provide care, treatment, or services to patients (CAMH, Standard HR.2.10, EPs 1-2, CAMH Refreshed Core, January 2008, p. HR- 10). We would expect that an orientation to the hospital’s EOP would be part of this in itial training. TJC-accredite d hospitals also must provide on-going training to their staff, including training on specific job -related safety (CAMH, Standard HR-2.30, EP 4, CAMH Refreshed Core, January 2008, p. HR-11), a nd we expect that emergency preparedness is part of such on-going training. Although TJC requirements do not specifically ad dress training for individuals providing services under arrangement or tr aining for volunteers consistent with their expected roles, it is210

standard practice for health care facilities to pr ovide some type of trai ning to all personnel, including those providing services under contract or arrangement and volunteers. If a hospital does not already provide such training, we would expect the additional burden to be negligible. Thus, for the TJC-accredited hospitals, the propos ed requirements would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Based on our experience with non TJC-accred ited hospitals, we expect that the non TJCaccredited hospitals have some type of emerge ncy preparedness training program and provide training to their staff regardi ng their duties and responsibilitie s under their emergency plans. However, under this proposed ru le, non TJC-accredited hospitals would need to compare their existing training programs with their risk asse ssments, emergency preparedness plans, policies and procedures, and communication plans. They also would need to revise, update, and, if necessary, develop new secti ons and new material for their training programs. To develop their training programs, hospita ls could draw upon the resources of federal, state, and local emergency preparedness agenci es, as well as state and national health care associations and organizations. In addition, hospitals could de velop partnerships with other hospitals and health care facilitie s to develop the necessary traini ng. Some hospitals might also choose to purchase off-the-shelf emergency traini ng programs or hire consultants to develop the programs for them. However, for purposes of estimating a burden for these requirements, we will assume that hospitals w ould use their own staff. Based on our experience with hospitals, we e xpect that complying with this requirement would require the involvement of the hospital ad ministrator, the risk management director, a health care trainer, and administ rative support staff. We estimate that it would require 40 burden hours for each hospital to develop an emergency preparedness training program at a cost of211

$2,094 for each non TJC-accredited hospital. We es timate that it would require 60,720 burden hours (40 burden hours for each non TJC-accred ited hospital x 1,518 non TJC-accredited hospitals = 60,720 burden hours) to comply with this requirement at a cost of $3,178,692 ($2,094 estimated cost for each hospital x 1,518 non TJC-accredited hospitals = $3,178,692 estimated cost). Proposed § 482.15(d) would also require hospitals to review and update their emergency preparedness training program at least annually. We believe that hospitals are already reviewing and updating their emergency preparedness traini ng programs periodically. Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Hospitals also would be required to mainta in documentation of their training. Based on our experience, we believe it is standard practi ce for hospitals to docum ent the training they provide to their staff, indi viduals providing services unde r arrangement, and volunteers. Therefore, compliance with this requirement w ould constitute a usual and customary business practice for the hospitals and not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 482.15(d)(2) would al so require hospitals to participate in a community mock disaster drill and a paper-based, tabletop exerci se at least annually. If a community mock disaster drill was not available, hospitals would have to conduct an individual, facility-based mock disaster drill. Hospitals also would be re quired to analyze their responses to, and maintain documentation of, all drills, exercises, and emerge ncy events. If a hospital experienced an actual emergency which required activation of its em ergency plan, it would be exempt from the requirement for a community or i ndividual, facility-based disaster drill for 1 year following the onset of the emergency (proposed § 482.15(d)(2)(ii )). Thus, to satisfy the burden for these212

requirements, hospitals would need to develop a scenario for each drill and exercise, as well as the documentation necessary for recording what happened. If a hospital participated in a community mock disaster drill, it probably would not need to deve lop a scenario for that drill. However, for the purpose of determining the burd en, we will assume that hospitals would need to develop at least two scenarios annually, one for a drill and one for an exercise. The TJC-accredited hospitals are required to test their EOP twice a year (CAMH, Standard EC.4.20, EP 1, p. EC-14a). In addition, TJ C-accredited hospitals mu st analyze all drills and exercises, identify deficiencies and areas for improvement, and modify their EOPs in response to the analysis of those tests (C AMH, Standard EC.4.20, EPs 15-17, p. EC-14b). Therefore, we expect that TJC-accredited hospita ls have already developed scenarios for drills and have the documentation needed for the analysis of their responses. Since tabletop exercises generally do not require as much preparation as drills and do not require different documentation than drills, we expect that any change a hospital needed to make to conduct a tabletop exercise

would be minimal. We expect that it would be a usual and customary business practice for the TJCaccredited hospitals to comply with the proposed requirement to prepare scenarios for emergency preparedness drills and exercises and to deve lop the necessary documentation. Thus, compliance with this requirement would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Based on our experience with non TJC-accredited hospitals, we expect that the remaining non TJC-accredited hospitals have some type of emergency pr eparedness training program and that most, if not all, of them already conduct so me type of drill or ex ercise to test their emergency preparedness plans. In addition, many hospitals participate in mock drills and exercises held by their communities, counties, and states. We also expect that many of these213

hospitals have already developed the required documentation for recording the events, and analyzing their responses to, their drills, exerci ses, and emergency events. However, we do not believe that all non-TJC accredited hospitals would be in compliance with our proposed requirements. Thus, we will analyze the burden for non TJC-accredited hospitals. The non TJC-accredited hospitals would be requ ired to develop scenarios for a drill and an exercise and the documentation necessary to record and analyze thei r responses to drills, exercises, and emergency events. Based on our experience with hospitals, we expect that the same individuals who developed the emergency preparedness training program would develop

the scenarios for the drills and exercises and th e accompanying documentation. We expect that the health care trainer would spend more ti me developing the scenarios and documentation. Thus, for each of the 1,518 non TJC-accredited hospitals to comply with these requirements, we estimate that it would require 9 burden hours at a cost of $523. Based on this estimate, for all 1,518 non TJC-accredited hospitals to comply would require 13,662 burden hours (9 burden hours for each non TJC-accredited hospital x 1,518 non TJC-accredited hospitals =13,662 burden hours) at a cost of $793,914 ($523 estimated cost for each non TJC-accredited hospital x 1,518 non TJC-accredited hospital = $793,914 estimated cost).

TABLE 7: BURDEN HOURS A ND COST ESTIMATES FOR ALL 4,928 HOSPITALS TO COMPLY WITH THE I CRs CONTAINED IN § 482.15 CONDITION: EMERGENCY PREPAREDNESS

1800141075 OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §482.15(a)(1) 0938- New 1,518 1,518 36 54,648 ** 4,437,114 0 4,437,114 §482.15(a)(1)- (4) 0938- New 1,518 1,518 62 94,116 ** 7,719,030 0 7,719,030 §482.15(b)(TJCaccredited) 0938- New 3,410 3,410 17 57,970 ** 4,852,430 0 4,852,430214

§482.15(b)(Non TJCaccredited) 0938- New 1,518 1,518 33 50,094 ** 3,981,714 0 3,981,714 §482.15(b)(7) 0938- New 4,928 4,928 8 39,424 ** 3,543,232 0 3,543,232 §482.15(c) 0938- New 1,518 1,518 10 15,180 ** 1,449,126 0 1,449,126 §482.15(d)(1) 0938- New 1,518 1,518 40 60,720 ** 3,178,692 0 3,178,692 §482.15(d)(2) 0938- New 1,518 1,518 9 13,662 ** 793,914 0 793,914

Totals 4,928 17,446 385,814 29,655,252 **The hourly labor cost is blended between the wages for multiple staffing levels. I. ICRs Regarding Condition of Participation: Emergency Preparedness for Transplant Centers (§ 482.78) Proposed § 482.78 would require tr ansplant centers to have po licies and procedures that address emergency preparedness. Proposed § 482.78( a) would require transp lant centers or the hospitals in which they operate to have an agre ement with at least one other Medicare-approved transplant center to provide tr ansplantation services and relate d care for its patients during an emergency. We propose that the agreements must address, at a minimum, the circumstances under which the agreement would be activated and the t ypes of services that would be provided during an emergency. "Transplantation services and related care" would include all of a center’s transplantrelated activities, ra nging from the evaluation of potential transplant recipients and living donors through post-operative care of transp lant recipients and living donor s. If the agreement does not include all services normally provided by the r eceiving transplant center, the agreement should state precisely what services th e receiving transplant center woul d provide during an emergency. We would also expect each transplant cente r to ensure that its agreement with another transplant center is sufficient to provide its patients with the care they would need during any period in which the transplant cent er could not provide it s services due to an emergency. If not,215

we would expect the transplant center to make additional agreements, when possible, to ensure

all services are available for its patients during an emergency. For the purpose of determining a burden fo r this requirement, we expect that each transplant center would devel op an agreement with one other transplant center to provide transplantation services and related care to its patients and living donors in an emergency. Based on our experience with transplant centers, we expect that developing this agreement would require the involvement of an administrator, the tran splant center medical director, the clinical transplant coordinator, and a hospital atto rney. We believe the clinical transplant coordinator would be primarily responsible for initially identifying what types of services the center’s patients w ould need to have provided by anot her transplant center during an emergency, as well as which transplant center(s) c ould provide such services . We expect that all

of the individuals we have identified would have to attend an initial meeting to approve the list of services needed by the center’s patients and th e transplant center(s) to contact. The hospital attorney would be primarily res ponsible for drafting an agreement with input from the transplant

center medical director. We estimate that it wo uld require 15 burden hours for each transplant center to develop an agreement with another transplant center to pr ovide services for its patients and living donors during an emergency, if applicable, at a cost of $1,388. According to CMS’ Center for Medicaid, Ch ildren’s Health Insura nce Program (CHIP), and Survey and Certification (CMC S), there are currently 770 tran splant programs or transplant centers. CMS uses the terms transplant cent ers and transplant programs interchangeably (70 FR 6145 and 72 FR 15210). Therefore, based on th e previous estimate, for all 770 transplant centers to comply with the requirement for an agreement, it would require 11,550 burden hours (15 burden hours for each transpla nt center x 770 transplant ce nters = 11,550 burden hours) at a216

cost of $1,068,760 ($1,388 estimated cost for each tran splant center x 770 tr ansplant centers = $1,068,760 estimated cost). Proposed § 482.78(b) would requ ire a transplant center to ensure that the written agreement between the hospital in which it is located and the hospita l’s designated OPO as required under § 482.100 addresses the duties and respons ibilities of the ho spital and the OPO during an emergency. We expect that transp lant centers would propose language; review any language proposed by the hospital, the OPO, or both; and approve the final agreement. The burden associated with ensuring that th e duties and responsibilities of the hospital and OPO during an emergency are addressed in the agreement woul d be the resources needed to draft, review, revise, and approve the language. Based on our experi ence with transplant centers, we expect that accomplishing these tasks would requi re the involvement of an administrator, the transplant center medical director , the clinical transplant coordi nator, and a hospital attorney. We expect that the medical director and the clin ical transplant coordinator would be primarily responsible for drafting, review ing, revising, and approving the la nguage of the agreement. A hospital attorney would be pr imarily responsible for drafti ng and reviewing any proposed language before the agreement was approved. The attorney would also brief the administrator and the administrator would appr ove the language. Thus, we estimate that it would require 15 burden hours for each transplant center to comply with the re quirement to ensure that the duties and responsibilities of the hospital and OPO are identified in these agreements at a cost of $1,388. A hospital can have multiple transplant centers, but the agreement is between the hospital and the OPO. Therefore, we will use 238 hos pitals for this burden analysis. This is the number of hospitals, according to CASPER, that have transplant programs. Based on this estimate, for 238 hospitals to comply with this requirement woul d require 3,570 burden hours217

(15 burden hours for each hospital x 238 hosp itals= 3,570 burden hours) at a cost of $330,344 ($1,388 estimated cost for each hospital x 238 hospitals = $330,344 estimated cost).

TABLE 8: BURDEN HO URS AND COST ESTIMATE S FOR ALL 770 TRANSPLANT CENTERS TO COMPLY WITH THE ICRs CONTAINED IN § 482.78 CONDITION: EMERGENCY PREPAREDNESS FOR TRANSPLANT CENTERS

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §482.78(a) 770 770 15 11,550 ** 1,068,760 0 1,068,760 §482.78(b) 238 238 15 3,570 ** 330,344 0 330,344

Totals 770 1008 15,120 1,399,104 **The hourly labor cost is blended between the wages for multiple staffing levels. J. ICRs Regarding Emergency Preparedness (§ 483.73) Proposed § 483.73 sets forth the emergency prep aredness requirements for long term care (LTC) facilities. LTC faciliti es would be required to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually (§ 483.73(a)). The emergency plan would have to include and be based upon a documented, facility-based and community based risk assessment that utilizes an all-hazards approach and must address missing residents (§ 483.73(a)(1)). LTC facilities would be required to develop and maintain emergency preparedness policies and procedures based on th eir emergency preparedness plan set forth in paragraph (a) of this section, th e risk assessment at paragraph (a)(1) of this section, and the communication plan that is requir ed in paragraph (c) of this se ction (§ 483.73(b)). Proposed § 483.73(d) would require LTC faci lities to develop and maintain emergency preparedness training and testing programs. We would usually be required to estimate the information collection requirements (ICRs) for these proposed requirements in accordance with chapter 35 of title 44, United States Code.218

However, sections 4204(b) and 4214(d), which co ver skilled nursing facilities (SNFs) and nursing facilities (NFs), resp ectively, of the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) provide for a waiver of Paperwork Reduc tion Act (PRA) requirements for the regulations that implement the OBRA ’87 requirements. Section 1819(d), as implemented by section 4201 of OBRA ’87, requires that SNFs “be administer ed in a manner that enables it to use its resources effectively and efficiently to attain or maintain the hi ghest practicable physical, mental, and psychosocial well-being of each resident (consistent with requirements established under subsection (f)(5)).” Section 1819(f)(5)(C) of the Act, requires the Secretary to establish criteria for assessing a SNF’s compliance with the requirem ent in subsection (d) with respect for disaster preparedness. Nursing facilities have the same requirement in sections 1919(d) and (f)(5)(C), as implemented by OBRA ’87. All of the proposed requirements in this rule relate to disaster prep aredness. We believe this waiver still applie s to those revisions we have proposed to existing requirements in part 483 subpart B. Thus, the ICRs for the proposed requir ements in § 483.73 are not subject to the PRA. K. ICRs Regarding Condition of Partic ipation: Emergency Preparedness (§ 483.475) Proposed § 483.475(a) would require Intermedia te Care Facilities fo r Individuals with Intellectual Disabilities (ICF/IID) to develop and maintain an emer gency preparedness plan that would have to be reviewed and updated at l east annually. We propose that the plan would include the elements set out at § 483.475(a)(1) th rough (4). We will discuss the burden for these activities individually beginning with the risk assessment. Proposed § 483.475(a)(1) would require each IC Fs/IID to develop a documented, facilitybased and community-based risk assessment u tilizing an all-hazard approach, including missing clients. We expect an ICF/IID to identify th e medical and non-medical emergency events it219

could experience in the facility and the community in which it is located and determine the likelihood of the facility experiencing an emergency due to th e identified hazards. In performing the risk assessment, we expect that an ICF/IID would need to consider its physical location, the geographical area in which it is located, and its client population. The burden associated with this requirement would be the time and effort necessary to perform a thorough risk assessment. The current Co Ps for ICFs/IID already require ICFs/IID to "develop and implement detailed written plans and procedures to meet all potential emergencies and disasters such as fires, severe weather, and missing clients" (42 CFR 483.470(h)(1)). During the process of developing these detailed wri tten plans and procedures , we expect that all ICFs/IID have already performed some type of ri sk assessment. However, as discussed earlier in the preamble, the current requirement is primarily designed to ensure the health and safety of the ICF/IID clients during emergencies th at are within the facility or in the facility’s local area. We do not expect that this requirement would be suffici ent to protect the health and safety of clients during more widespread local, stat e, or national emergencies. In addition, an ICF/IID current risk assessment may not address all of th e elements required in proposed § 483.475(a). Therefore, all ICFs/IID woul d have to conduct a thorough revi ew of their current risk assessments, if they have them, and then perform the necessary tasks to ensure that their risk assessments comply with the requirements of this section. We have not designated any specific process or format for ICFs/IID to use in conducting their risk assessments because we expect IC Fs/IID would need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we expect that in the process of developing a risk assessment, an ICF/IID would in clude representatives from, or obtain input from, all of the major departments in their facilities. Based on our experience with220

ICFs/IID, we expect that conducting the risk a ssessment would require the involvement of the

ICF/IID administrator and a professional staff person, such as a registered nurse. We expect that

both individuals would attend an initial meeti ng, review relevant sections of the current assessment, develop comments and recommendati ons for changes to the assessment, attend a follow-up meeting, perform a final re view, and approve the risk assessment. We expect that the administrator would coordinate the meetings, pe rform an initial review of the current risk assessment, critique the risk assessment, o ffer suggested revisions, coordinate comments, develop the new risk assessment, and assure th at the necessary parties approve the new risk assessment. We also expect that the admi nistrator would spend more time reviewing and working on the risk assessment. Thus, we estimat e that complying with this requirement would require 10 burden hours to complete at a co st of $461. There are currently 6,442 ICFs/IID. Therefore, it would require an estimated 51,536 burden hours (8 burden hours for each ICF/IID x 6,442 ICFs/IID = 51,536 burden hours) for all ICFs/IID to comply with this requirement at a cost of $2,969,762 ($461 estimated cost for each ICF/IID x 6,442 ICFs/IID = $2,969,762 estimated cost). Under this proposed rule, ICFs/IID w ould be required to develop emergency preparedness plans that addressed the emergency events that could affect not only th eir facilities

but also the communities in which they are located. An ICF/IID cu rrent disaster plan might not address all of the medical and non-medical emerge ncy events identified by its risk assessment, include strategies for addressi ng those emergency events, or a ddress its patient population. It may not specify the type of services the ICF/IID has the ability to provide in an emergency, or continuity of operations, including delegation of authority and succession plans. Thus, we expect that each ICFs/IID would have to review its current plans and compare them to its risk221

assessments. Each ICF/IID would then need to update, revise, and, in some cases, develop new sections to comply with our proposed requirements. The burden associated with this requirement would be the resources needed to review, revise, and develop new sections for an exis ting emergency plan. Based upon our experience with ICFs/IID, we expect that the same indivi duals who were involved in the risk assessment would be involved in developing the facility’s new emergency preparedness plan. We also expect that developing the plan would require more time to complete than the risk assessment. We estimate that it would require 9 burden hours at a cost of $525 for each ICF/IID to develop an emergency plan that complied with the requirem ents in this section. Based on this estimate, it would require 57,978 burden hours (9 burden ho urs for each ICF/IID x 6,442 ICFs/IID = 57,978 burden hours) to complete the plan at a cost of $3,382,050 ($525 estimated cost for each ICF/IID x 6,442 ICFs/IID = $3,382,050 estimated cost). The ICF/IID also would be required to re view and update its emergency preparedness plan at least annually. We belie ve that ICFs/IID already revi ew their emergency preparedness plans periodically. Thus, compliance with th is requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 483.475(b) would require each ICF/ IID to develop and implement emergency preparedness policies and procedures, based on its emergency plan set forth in paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this se ction, and the communication plan at paragraph (c) of this section. We would also require the ICF/IID to review and update these policies and procedures at least annually. At a minimum, the ICF/IID policies and procedures would be required to addre ss the requirements listed at § 483.475(b)(1) through (8).222

We expect all ICFs/IID to compare their current emergency prep aredness policies and procedures to their emergency preparedness plan s, risk assessments, and communication plans. They would then need to revise and, if necessar y, develop new policies and procedures to ensure they comply with the requirements in this section. We expect that all ICFs/II already have some emergency preparedness policies and procedures. As discussed earlier, the current CoPs for ICFs/IID require them to have "written . . . procedures to meet all potential emergencies and disasters" (§ 483.470(h)(1)). In addition, we expect that all ICFs/IID alrea dy have procedures that comply with some of the other proposed requirements in this section. For example, as will be discussed later, cu rrent regulations require ICFs/IID to perform drills, evaluate the effectiv eness of those drills, and take corrective action for any problems they detect (§ 483.470(i)). We expect that all ICFs/IID have developed procedures for safe evacuation from and return to the ICF/IID (§ 483.475(b)(4)) and a process to document and analyze drills and revise their em ergency plan when they detect problems. We expect that each ICF/IID would need to review its current disaster policies and procedures and assess whether they incorporate all of the elements we are proposing. Each

ICF/IID also would need to re vise, and, if needed, develop ne w policies and procedures. The burden incurred by reviewing, revising, updating and, if necessa ry, developing new emergency policies and procedures would be the resources needed to ensure that the ICF/IID policies and procedures complied with the proposed requirements of this subsection. We expect

that these tasks would involve the ICF/IID administrator and a registered nurse. We estimate that for each ICF/IID to comp ly would require 9 burden hours at a cost of $525. Based on this estimate, for all 6,442 ICFs/IID to comply w ith this requirement would require 57,978 burden hours (9 burden hours for each ICF/IID x 6,442 ICFs /IID = 57,978 burden hours) at a cost of223

$3,382,050 ($525 estimated cost for each ICF/IID x 6,442 ICFs/IID = $3,382,050 estimated cost). We expect ICFs/IID to review and upda te their emergency pr eparedness policies and procedures at least annually. We believe that ICFs/IID already revi ew their policies and procedures periodically. Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 483.475(c) would require each IC F/IID to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. The

ICF/IID would also have to re view and update the plan at le ast annually. The communication plan must include the information set out at § 483.475(c)(1) through (7). We expect all ICFs/IID to compare their current emergency preparedness communications plans, if they have them, to th e requirements in this section. ICFs/IID also would need to perform any tasks necessary to ensure that they document their communication plans and that those plans co mply with the proposed require ments of this subsection. We expect that all ICFs/IID have some type of emergency preparedness communication plan. The current CoPs require ICFs/IID to have written disast er plans and procedures for all potential emergencies (§ 483.470(h)(1)). We expect that an integral pa rt of these plans and procedures would include communi cation. Further, it is standa rd practice for health care organizations to maintain contact information fo r both staff and outside sources of assistance;

have alternate means of communication in case th ere is an interruption in phone service to the facility (for example, cell phones); and have a method for sh aring information and medical documentation with other health care providers to ensure continuity of care for their clients.224

However, many ICFs/IID may not have a formal, written emergency preparedness communication plan, or their plan may not comply with all the elements we are requiring. The burden associated with complying with this requirement would be the resources required to ensure that the ICF/IID emergenc y communication plan complied with the proposed requirements. Based upon our experience with ICFs/IID, we anticipate that meeting the requirements in this section would primarily require the involvement of the ICF/IID administrator and a registered nurse. We estimate that for each ICF/IID to comply with the proposed requirement would requ ire 6 burden hours at a cost of $350. Therefore, for all 6,442 ICFs/IID to comply with this requirement would require an estimated 38,652 burden hours (6 burden hours for each ICF/IID x 6,442 IC Fs/IID = 38,652 burden hours) at a cost of $2,254,700 ($350 estimated cost for each ICF/IID x 6,442 ICFs/IID = $2,254,700 estimated cost).

ICFs/IID would also have to review and update their emergency preparedness communication plans at least annua lly. We believe that ICFs/IID already review their plans, policies, and procedures periodically. Thus, comp liance with this requireme nt would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 483.475(d) would require ICFs/IID to develop and maintain emergency preparedness training and testing programs that would have to be reviewed and updated at least annually. Each ICF/IID would also have to m eet the requirements for evacuation drills and training at § 483.470(i). To comply with the requirements at § 483.475( d)(1), an ICF/IID would have to provide initial training in emergency prep aredness policies and procedures to all new and existing staff,225

individuals providing services under arrangement, and volunteers, c onsistent with their expected roles, and maintain documentation of the traini ng. Thereafter, the ICF/IID would have to provide emergency preparedness training at least annually. The ICFs/IID would need to compare th eir current emergency preparedness training programs’ contents to their risk assessments and updated emergency preparedness plans, policies and procedures, and communication plans and th en revise and, if necessary, develop new sections for their training programs to ensure they complied with the proposed requirements. The current ICFs/IID CoPs require ICFs/IID to pe riodically review and pr ovide training to their staff on the facility’s emergency plan (§ 483.470(h)(2 )). In addition, staff on all shifts must be trained to perform the tasks to which they ar e assigned for evacuations (§ 483.470(i)(1)(i)). We expect that all ICFs/IID have emergency prep aredness training programs for their staff. However, under this proposed ru le, each ICF/IID would need to review its current training program and compare its contents to its upda ted emergency preparedness plan, policies and procedures, and communications pla n. Each ICF/IID also would need to revise and, if necessary, develop new sections for their training progr am to ensure it complied with the proposed requirements.

The burden would be the time and effort necessary to comply with the proposed requirements. We expect that a registered nu rse would be primarily involved in reviewing the ICF/IID current training program and the IC F/IID updated emergency preparedness plan, policies and procedures, and co mmunication plan; determining what tasks would need to be performed to comply with the proposed require ments of this subsection; accomplishing those tasks, and developing an updated training program. We expect the administrator would work with the registered nurse to update the training program. We estimate that it would require226

7 burden hours for each ICF/IID to develop an emergency training program at a cost of $363. Therefore, it would require an estimated 45,094 burden hours (7 burden hours for each ICF/IID x 6,442 ICFs/IID = 45,094 burden hours) to comply w ith this requirement at a cost of $2,338,446 ($363 estimated cost for each ICF/IID x 6,442 ICFs/IID = $2,338,446 estimated cost).

ICFs/IID would have to review and u pdate their emergency preparedness training program at least annually. We believe that ICFs/IID al ready review their emergency preparedness training programs periodically. Th us, compliance with this requirement would

constitute a usual and customar y business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 483.475(d)(2) would require ICFs/IID to participate in a community mock disaster drill and a paper-based, ta bletop exercise at least annuall y. The ICFs/IID would also be required to analyze their responses to and ma intain documentation of all drills, tabletop exercises, and emergency events, and revise thei r emergency plans, as needed. If an ICF/IID experienced an actual natural or man-made emer gency that required activation of its emergency plan, the ICF/IID would be exempt from engaging in a community or indi vidual, facility-based mock disaster drill for 1 year following the onset of the actual event. To comply with this requirement, an ICF/IID would need to devel op scenarios for each drill and exercise. An

ICF/IID also would have to deve lop the required documentation. The current ICF/IID CoPs require them to " hold evacuation drills at least quarterly for each shift and under varied conditions to . . . evaluate the effectiveness of emergency and disaster plans and procedures" (§ 483.470(i)(1)). In addition, ICFs/IID mu st "actually evacuate clients during at least one drill each year on each shift . . . f ile a report and evaluation on each evacuation drill . . . and investig ate all problems with evacuation drills, including accidents, and227

take corrective action" (42 CFR 483.470(i)(2)). Thus, all 6,450 ICFs/ IID already conduct quarterly drills. However, the current CoPs do not indicate the type of drills ICFs/IID must perform. In addition, although the CoPs require that a report and evaluation be filed, this requirement does not ensure that ICFs/IID have developed the type of paperwork we propose requiring or that scenarios are used for each dr ill or table top exercise. For the purpose of determining a burden for these requirements, all IC Fs/IID would have to develop scenarios, one for the drill and one for the table top exercise , and all ICFs/IID woul d have to develop the necessary documentation. The burden associated with these requiremen ts would be the resources the ICF/IID would need to comply with the proposed requirement s. We expect that complying with these requirements would likely require the involvement of a registered nurse. We expect that the registered nurse would develop th e required documentation. We also expect that the registered nurse would develop the scenarios for the drill an d exercise. We estimate that these tasks would require 4 burden hours at a cost of $188. Base d on this estimate, for all 6,442 ICFs/IID to comply, it would require 25,768 burden hours (4 burden hours for each ICF/IID x 6,442 ICFs/IID = 25,768 burden hours) at a cost of $1,211,096 ($188 estimated cost for each ICF/IID x 6,442 ICFs/IID = $1,211,096 estimated cost).

TABLE 9: BURDEN HOURS AND COST ESTIMATES FOR ALL 6,442 ICFs/IID TO COMPLY WITH THE ICRs CONTAINE D IN § 485.475 CONDITION: EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §483.475(a)(1) 6,442 6,442 8 51,536 ** 2,969,762 0 2,969,762 §483.475(a)(1)-(4) 6,442 6,442 9 57,978 ** 3,382,050 0 3,382,050 §483.475(b) 6,442 6,442 9 57,978 ** 3,382,050 0 3,382,050 §483.475(c) 6,442 6,442 6 38,652 ** 2,254,700 0 2,254,700 §483.475(d)(1) 6,442 6,442 7 45,094 ** 2,338,446 0 2,338,446228

§483.475(d)(2) 6,442 6,442 4 25,768 ** 1,211,096 0 1,211,096 Totals 6,442 38,652 277,006 15,538,104 **The hourly labor cost is blended between the wages for multiple staffing levels. L. ICRs Regarding Condition of Partic ipation: Emergency Preparedness (§ 484.22) Proposed § 484.22(a) would require home h ealth agencies (HHAs) to develop and maintain emergency preparedness plans. Each HHA also would be required to review and update the plan at least annually. Specifically, we propose that th e plan meet the requirements listed at § 484.22(a)(1) through (4). We will disc uss the burden for these activities individually, beginning with the risk assessment. Accreditation may substan tially affect the burden a HHA would experience under this proposed rule. HHAs are accredited by three di fferent accrediting organi zations (AOs): The Joint Commission (TJC), The Community Health Accreditation Program (CHAP), and the Accreditation Commission for Health Care, Inc. (ACHC). After reviewing the accreditation standards for all three AOs, neither the standard s for CHAP nor the ones for ACHC appeared to ensure substantial compliance with our proposed re quirements in this rule. Therefore, the HHAs accredited by CHAP and ACHC w ill be included with the non- accredited HHAs for the purposed of determining the burden for this proposed rule. There are currently 12,349 HHAs . There are 1,734 TJC-accre dited HHAs. A review of TJC deeming standards indicates that the 1,734 TJC-accredited HHAs already perform certain tasks or activities that would partially or completely satisfy our proposed requirements. Therefore, since TJC accreditation is a significa nt factor in determining the burden, we will analyze the burden for the 1,734 TJC-accredite d HHAs separately from the 10,615 non TJCaccredited HHAs (12,349 HHAs – 1,734 TJC-accredited HHAs = 10,615 non TJC-accredited HHAs), as appropriate. Note that we obtain data on the number of HHAs, both accredited and non-accredited, from the CMS CASPER data sy stem, which is update d periodically by the229

individual states. Due to varia tions in the timeliness of the data submissions, all numbers are approximate, and the number of accredited and non-accredited HHAs may not equal the total

number of HHAs. Section 484.22(a)(1) would re quire that HHAs develop a doc umented, facility-based and community-based risk assessment utilizing an al l-hazards approach. To perform this risk assessment, an HHA would need to identify the medical and non-medical emergency events the HHA could experience and how the HHA’s essential business functions and ability to provide services could be impacted by those emergency even ts based on the risks to the facility itself and the community in which it is located. We would expect HHAs to consider the extent of their service area, including the location of any branch offices . An HHA with an existing risk assessment would need to review, revise a nd update it to comply with our proposed requirements. For TJC accreditation standards, we used TJC’s CAMHC Refreshed Core, January 2008 pages from the Comprehensive Accreditation Ma nual for Home Care 2008 (CAMHC). In the chapter entitled, "Environmental Safety and Equipment Management" (EC), TJC accreditation standards require HHAs to conduct proactive risk assessments to "evaluat e the potential adverse impact of the external environment and the servic es provided on the security of patients, staff, and other people coming to the organization’s facilities" (CAMHC, Standard EC.2.10, EP 3, p. EC-7). These proactive risk assessments should evaluate the risk to the entire organization, and

the HHA should conduct one of these assessments wh enever it identifies a ny new external riskfactors or begins a new service (CAMHC, Standard EC.2.10, p. EC-7). Moreover, TJCaccredited HHAs are required to develop and main tain "a written emergency management plan describing the process for disaster readine ss and emergency management . . ." (CAMHC,230

Standard EC.4.10, EP 3, p. EC-9). In addition, TJC requires that these plans provide for "processes for managing . . . activit ies related to care, treatment, and services (for example, scheduling, modifying, or discon tinuing services; cont rolling information about patients; referrals; transporting patients) . . . logistics relating to critical supplies . . . communicating with patient" during an emergency (CAMHC, Standard EC.4.10, EP 10, p. EC-9-10). We expect that any HHA that has conducted a proactive risk assessment and developed an emergency management plan that satisfies the previously described TJC accredit ation requirements has already conducted a risk assessm ent that would satisfy our proposed requirements. Any tasks needed to comply with our proposed requirement s would not result in any additional burden. Thus, for the 1,734 TJC-accredited HHAs, the risk assessment requiremen t would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). It is standard practice for health care facilities to prepare for common internal and external medical and non-medical emergencies, based on their location, structure, and the services they provide. We believe that the 10,615 non TJC-accredited HHAs have conducted some type of risk assessment. However, those ri sk assessments are unlikel y to satisfy all of our proposed requirements. Therefore, we w ill analyze the burden for the 10,615 non TJCaccredited HHAs to comply. We have not designated any specific proce ss or format for HHAs to use in conducting

their risk assessments because we believe that HHAs need the flexibility to determine the best way to accomplish this task. However, we expect that HHAs would include representatives from or input from all of their major departments. Based on our experience working with HHAs, we expect that conducting the risk assessment would require the involvement of an HHA231

administrator, the director of nur sing, director of rehabilitation, and the office manager. We expect that these individuals w ould attend an initial meeting, revi ew relevant sections of the current assessment, prepare and forward their comme nts to the administrator and the director of nursing, attend a follow-up meeting, perform a final review, and approve the new risk assessment. We expect that the director of nur sing would coordinate the meetings, review the current risk assessment, provide suggestions, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approve it. We expect that the director of nursing would spend more time developing the f acility’s new risk assessment than the other

individuals. We estimate that the risk a ssessment would require 11 burden hours for each non TJC-accredited HHA to complete at a cost of $605. There are currently about 10,615 non TJCaccredited HHAs. We estimate that for all non TJC-accredited HHAs to comply with this requirement would require 116,765 burden hours (11 burden hours for each non TJC-accredited HHA x 10,615 non TJC-accredited HHAs = 116,765 bur den hours) at a cost of $6,422,075 ($605 estimated cost for each non TJC-accredited HHA x 10,615 non TJC-accredited HHAs = $6,422,075 estimated cost). After conducting a risk assessment, HHAs would have to develop an emergency preparedness plan that complied with § 484.22(a )(1) through (4). As discussed earlier, TJC already has accreditation standards similar to the requirements we propose at § 484.22(a). Thus, we expect that TJC-accredited HHAs have an em ergency preparedness plan that would satisfy most of our proposed requirements. Although th e current HHA CoPs require that there be a qualified person who "is authorized in writing to act in the ab sence of the administrator" (§ 484.14(c)), the TJC standards do not specifi cally address delegations of authority or succession plans. Furthermore, TJC standards do not address persons-at-risk. Therefore, we232

expect that the 1,734 TJC-accredite d HHAs would incur some burden due to reviewing, revising, and in some cases, developing new sections for their emergency preparedness plans. However,we will analyze the burden for TJC-accredited HHAs separately from the 10,615 non TJCaccredited HHAs because we expect the burden for TJC-accredited HHAs to be substantially

less. We expect that the 10,615 non TJC-accredited HHAs already have some type of emergency preparedness plan, as well as dele gations of authority a nd succession plans. However, we also expect that their plans do not comply with all of our proposed requirements. Thus, all non TJC-accredited HHAs would need to review their current plans and compare them to their risk assessments. They also would n eed to update, revise, and, in some cases, develop new sections for their emergency plans. Based on our experience with HHAs, we exp ect that the same individuals who were

involved in the risk assessment would be i nvolved in developing the emergency preparedness plan. We estimate that complying with this requirement would require 10 burden hours for each TJC-accredited HHA at a cost of $546. Therefore, for all 1,734 TJC-accredited HHAs to comply would require an estimated 17,340 burden hours (10 burden hours for each TJC-accredited HHA x 1,734 TJC-accredited HHAs = 17,340 burden hours) at a cost of $946,764 ($546 estimated cost for each HHA x 1,734 TJC-accredited HHAs = $946,764 estimated cost). We estimate that complying with this requirement would require 15 burden hours for each of the 10,615 non TJC-accredited HHAs at a cost of $819. Therefore, for all 10,615 non TJC-accredited HHAs to comply would requ ire an estimated 159,225 burden hours (15 burden hours for each non TJC-accredited HHA x 10,615 non TJC-accredited HHAs = 159,225 burden233

hours) at a cost of $8,693,685 ($819 estimated cost for each non TJC-accredited HHA x 10,615 non TJC-accredited HHAs = $8,693,685 estimated cost). Based on these estimates, for all 12,349 HHAs to develop an emergency preparedness plan that complies with our proposed requireme nts would require 176,565 bur den hours at a cost of $9,640,449. We would also require HHAs to review a nd update their emergency preparedness plans at least annually. We believe that HHAs ar e already reviewing and updating their emergency preparedness plans periodically. Hence, complia nce with this requirement would constitute a usual and customary business practice for HHAs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 484.22(b) would require each HHA to develop and implement emergency preparedness policies and procedures base d on the emergency plan, risk assessment, communication plan as set forth in § 484.22(a), (a )(1), and (c), respectively. The HHA would also have to review and update its policies and procedures at l east annually. We would require that, at a minimum, these policies and pro cedures address the requirements listed at § 484.22(b)(1) through (6). We expect that HHAs would review th eir emergency preparedness policies and procedures and compare them to their risk as sessments, emergency preparedness plans, and emergency communication plans. HHAs would need to revise or, in some cases, develop new policies and procedures to ensure they complie d with all of the proposed requirements. In the chapter entitled, "Leadership," TJ C accreditation standards require that each HHA’s "leaders develop policies and procedures th at guide and support patient care, treatment, and services" (CAMHC, Standard LD.3.90, EP 1, p. LD-13). In addition, TJC accreditation234

standards and EPs specifically require each HHA to develop and maintain an emergency management plan that provides processes for mana ging activities related to care, treatment, and services, including scheduling, modifying, or discontinuing services (CAMHC, Standard EC.4.10, EP 10, EC-9); identify back up communication systems in the event of failure due to an emergency event (CAMHC, Standard EC.4.10, EP 18, EC-10); and develop processes for critiquing tests of its emergency preparedness plan and modifying the plan in response to those critiques (CAMHC, Standard EC.4.20, EPs 15-17, p. EC-11). We expect that the 1,734 TJC-accredited HHAs already have emergency preparedness policies and procedures that address some of the proposed requirements at § 484.22(b). However, we do not believe that TJC accredita tion requirements ensure that TJC-accredited HHAs’ policies and procedures address all of our proposed requirements for emergency policies and procedures. Thus, we will include the 1,734 TJC-accredited HHAs with the 10,615 non TJC-accredited HHAs in our analysis of the burden for proposed § 484.22(b). Under proposed § 484.22(b)(1), the HHA’s indi vidual plans for patients during a natural or man-made disaster would be included as part of the comprehensive patient assessment, which would be conducted according to the provision s at § 484.55. We expect that HHAs already collect data during the comprehe nsive patient assessment that they would need to develop for each patient’s emergency plan. At § 484.22(b )(2), we propose requiring each HHA to have procedures to inform state and local emerge ncy preparedness officials about HHA patients in

need of evacuation from their re sidences at any time due to an emergency situation based on the patients’ medical and psychiatric co ndition and home environment. Existing HHA regulations already address so me aspects of proposed § 484.22(b)(1) and (b)(2). For example, regulations at § 484.18 ma ke it clear that HHAs are expected to accept235

patients only on the basis of a reasonable expect ation that they can provide for the patients’ medical, nursing, and social needs in the patients ’ home. Moreover, the plan of care for each patient must cover any safety measures necessa ry to protect the patient from injury § 484.18(a). Thus, the activities necessary to be in complia nce with § 484.22(b)(1) an d (2) would constitute usual and customary business practices for HHA and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).We expect that all 12,349 HHAs (1,734 TJC-accredited HHAs + 10,615 non TJCaccredited HHAs = 12,349 HHAs) have some emerge ncy preparedness policies and procedures. However, we also expect that all HHAs would n eed to review their polic ies and procedures and revise and, if necessary, develop new policies an d procedures that complied with our proposed requirements set out at § 484.22(3) through (6). We expect that a professional staff person, most likely the director of nursing, would review the HHA’s policies and procedures and make recommendations for changes or development of additional policies and procedures. The

administrator or director of nursing would brief representative s of most of the HHA’s major departments and assign staff to make necessa ry revisions and draf t any new policies and procedures. We estimate that complying with this requirement would require 18 burden hours for each HHA at a cost of $996. Thus, for all 12,349 HHAs to comply with all of our proposed requirements would require an estimated 222,2 82 burden hours (18 burden hours for each HHA x 12,349 HHAs = 222,282 burden hours) at a cost of $12,299,604 ($996 estimated cost for each HHA x 12,349 HHAs = $12,299,604 estimated cost). We are also proposing that HHAs review and update their emergency preparedness policies and procedures at least annually. The current HHA CoPs already require that "a group of professional personnel . . . re views the agency’s policies govern ing scope of services offered"236

(42 CFR 484.16). Thus, we believe that complyi ng with this requirement would constitute a usual and customary business practice for HHAs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). In proposed § 484.22(c), each HHA would be required to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. We propose that each HHA review and update its comm unication plan at leas t annually. We would require that the emergency communication plan include the information listed at § 484.22(c)(1) through (6). It is standard practice for h ealth care facilities to mainta in contact information for both

staff and outside sources of a ssistance; alternate means of co mmunication in case there is an interruption in phone service to the facility; and a me thod of sharing information and medical documentation with other health care providers to ensure continuity of care for patients. All TJC-accredited HHAs are required to identify backup communication systems for

both internal and external communication in cas e of failure due to an emergency (CAMHC, Standard EC.4.10, EP 18, p. EC-10). They are require d to have processes for notifying their staff when the HHA initiates its emergency plan (CAMHC, Standard EC.4.10, EP 7, p. EC-9); identifying and assigning staff to ensure that essential functions are covered during emergencies (CAMHC, Standard EC.4.10, EP 9, p. EC-9); and activities related to care, treatment, and services, such as controlling information a bout their patients (CAMHC, Standard EC.4.10, EP 10, p. EC-9). However, we do not believe these requirements ensure that all TJC-accredited HHAs are already in compliance with our propose d requirements. Thus , we will include the 1,734 TJC-accredited HHAs with the 10,615 non TJC- accredited HHAs in assessing the burden for this requirement.237

We expect that all 12,349 HHAs maintain so me contact information, an alternate means of communication, and a method fo r sharing information with ot her health care facilities. However, this would not ensure that all HHAs would be in compliance with our proposed requirements for communication plans. Thus, we will analyze the burden for this requirement for all 12,349 HHAs. The burden associated with complying with th is requirement would be the time and effort necessary for each HHA to review its existing co mmunication plan, if any, and revise it; and, if necessary, to develop new sections for the emergency preparedness communication plan to ensure that it complied with our proposed re quirements. Based on our experience with HHAs, we expect that these activities would require the involvement of the HHA’s administrator, director of nursing, director of rehabilitation, and office manager. We estimate that complying with this requirement would require 10 burden hours for each HHA at a cost of $520. Thus, for all 12,349 HHAs to comply with these require ments would require an estimated 123,490 burden hours (10 burden hours for each HHA x 12,349 HHAs = 123,490 burden hours) at a cost of $6,421,480 ($520 estimated cost for each HHA x 12,349 HHAs = $6,421,480 estimated cost). We propose requiring HHAs to review a nd update their emergency preparedness communication plans at least annua lly. We believe that HHAs al ready review their emergency preparedness plans periodically. Thus, complia nce with this requirement would constitute a usual and customary business practice for HHAs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Section 484.22(d) would require each HHA to develop and maintain an emergency preparedness training and testing program. Each HHA would also have to review and update its238

training and testing program at least annually. We propose re quiring that each HHA meet the requirements listed at § 484.22(d)(1) and (2). Proposed § 484.22(d)(1) states that each HHA w ould have to provide initial training in emergency preparedness policies and procedures to all new and existi ng staff, individuals providing services under arrangemen t, and volunteers, consistent w ith their expected roles, and maintain documentation of the training. Thereaf ter, the HHA would have to provide emergency preparedness training at least a nnually. Each HHA would also have to ensure that their staff could demonstrate knowledge of their emergency procedures. Based on our experience with HHAs, we exp ect that all 12,349 HHAs have some type of emergency preparedness training program. The 1,734 TJC-accredited HHAs are already required to provide both an ini tial orientation to their staff before they can provide care, treatment, or services (CAMHC, Standard HR.2.10, EP 2, p. HR-6) and "ongoing in-services, training or other staff activities [that] emphasize job-related aspects of safety . . ." (CAMHC, Standard HR.2.30, EP 4, p. HR-8). Since emergenc y preparedness is a crit ical aspect of jobrelated safety, we expect that TJC-accredited HHAs would ensure that their orientations and ongoing staff training would include the facil ity’s emergency preparedness policies and procedures. However, we expect that under proposed § 484.22(d), all HHAs would need to compare their training and testing programs with their ri sk assessments, emergency preparedness plans, emergency policies and procedures, and emergency communication plans. We expect that most HHAs would need to revise and, in some cases, de velop new sections for their training programs to ensure that they complied with our proposed requirements. In addition, HHAs would need to provide an orientation and annual training in th eir facilities’ emergency preparedness policies239

and procedures to individuals providing services unde r arrangement and volunteers, consistent with their expected roles. Hence, we will anal yze the burden of these proposed requirements for all 12,349 HHAs. Based on our experience with HHAs, we exp ect that complying with this requirement would require the involvement of an administrator, the director of training, dire ctor of nursing, director of rehabilitation, and the office manager. We expect that the dir ector of training would spend more time reviewing, revising or developing new sections for the training program than

the other individuals. We estimate that it would require 16 burden hours for each HHA to develop an emergency preparedne ss training and testing program at a cost of $756. Thus, for all 12,349 HHAs to comply would require an estim ated 197,584 burden hours (16 burden hours for each HHA x 12,349 HHAs = 197,584 burden hours) at a cost of $9,335,844 ($756 estimated cost for each HHA x 12,349 HHAs = $9,335,844 estimated cost). We also propose requiring HHAs to review and update their emergency preparedness training programs at least annua lly. We believe that HHAs alr eady review their training and testing programs periodically. Thus, compliance w ith this requirement would constitute a usual and customary business practice for HHAs and woul d not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 484.22(d)(2) would require each HHA to conduct drills and exercises to test its emergency plan. Each HHA would have to pa rticipate in a community mock disaster drill and conduct a paper-based, tabletop exercise at least annually. If a community mock disaster drill was not available, each HHA would have to conduct an individual, facility-based mock disaster drill at least annually. If an HHA experienced an actual natural or man-made emergency that required activation of the emergency pla n, it would be exempt from engaging in a240

community or individual, facility-based mock disa ster drill for 1 year following the onset of the

actual event. Each HHA would also be required to analyze its responses to and maintain documentation of all drills, tabl etop exercises, and emergency ev ents, and revise its emergency plan as needed. For the purposes of determini ng the burden for these requirements, we expect that all HHAs would have to comply with all of the proposed requirements. The burden associated with complying with th is requirement would be the time and effort necessary to develop the scenar ios for the drill and the exerci se and the required documentation. All TJC-accredited HHAs are required to test their emergency mana gement plan once a year; the test cannot be a tabletop exerci se (CAMHC, Standard EC.4.20, EP 1 and Note 1, p. EC-11). The TJC also requires HHAs to critique the drills a nd modify their emergency management plans in response to those critiques (CAMHC, Standard EC.4.20, EPs 15-17, p. EC-11). Therefore, TJCaccredited HHAs already prepare scenarios for drills, develop documentation to record the events during drills, critique them, and modify their emergency preparedness plans in response. However, TJC standards do not describe what type of drill HHAs must conduct or require a tabletop exercise annually. Thus, TJC accredit ation standards would not ensure that TJCaccredited HHAs would be in compliance with ou r proposed requirements. Therefore, we will include the 1,734 TJC-accredited HHAs with the 10,615 non TJC-accredited HHAs in our analysis of the burden for these requirements. Based on our experience with HHAs, we e xpect that the same individuals who are responsible for developing the HHA’s training a nd testing program would develop the scenarios for the drills and exercises and the accompanying documentation. We expect that the director of nursing would spend more time on these activities than would the other in dividuals. We estimate that it would require 8 burden hours for each HHA to comply with the proposed requirements at241

an estimated cost of $373. Thus, for all 12,349 HHAs to comply with the requirements in this section would require an estimated 98,792 burden hours (8 burden hours for each HHA x 12,349 HHAs = 98,792 burden hours) at a cost of $4,606,177 ($373 estimated cost for each HHA x 12,349 HHAs = $4,606,177 estimated cost). Based upon the previous analysis, we estima te that it would require 909,855 burden hours for all HHAs to comply with the ICRs containe d in this proposed rule at a cost of $51,034,965.

TABLE 10: BURDEN HOURS AND COST ESTIMATES FOR ALL 12,349 HHAS

TO COMPLY WITH THE ICRs CONTAINED IN § 484.22 CONDITION: EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Number of Respondents Number of Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §484.22(a)(1) 0938- New 10,615 10,615 11 116,765 ** 6,422,075 0 6,422,075 §484.22(a)(1)- (4)(TJCaccredited) 0938- New 1,734 1,734 10 17,340 **

946,764 0 946,764

§484.22(a)(1)- (4)(Non TJCaccredited) 0938- New 10,615 10,615 18 159,225 **

8,693,685 0 8,693,685

§484.22(b) 0938- New 12,349 12,349 18 222,282 ** 12,299,604 0 12,299,604 §484.22(c) 0938- New 12,349 12,349 10 123,490 ** 6,421,480 0 6,421,480 §484.22(d)(1) 0938- New 12,349 12,349 16 197,584 ** 9,335,844 0 9,335,844 §484.22(d)(2) 0938- New 12,349 12,349 8 98,792 ** 4,606,177 0 4,606,177 Total 935,478 48,725,629 **The hourly labor cost is blended between the wages for multiple staffing levels.242

M. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 485.68) Proposed § 485.68(a) would require all Co mprehensive Outpatient Rehabilitation Facilities (CORFs) to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. We propose that the plan meet the requirements listed at § 485.68(a)(1) through (5). Proposed § 485.68(a)(1) would require a CORF to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. The CORFs would need to identify the medical and non-medical em ergency events they could experience. The current CoPs for CORFs already require CORFs to have "written policies and procedures that specifically define the handling of patients, pers onnel, records, and the p ublic during disasters" (§ 485.64). We expect that all CORFs have perf ormed some type of risk assessment during the process of developing their disast er policies and procedures. Ho wever, their risk assessments may not meet our proposed requireme nts. Therefore, we expect that all CORFs would need to review their existing risk assessments and perf orm the tasks necessary to ensure that those assessments meet our proposed requirements. We have not designated any specific proce ss or format for CORFs to use in conducting their risk assessments because we believe they need the flexibility to determine how best to accomplish this task. However, we expect that CORFs would obtain input from all of their major departments. Based on our experience with CORFs, we expect that conducti ng the risk assessment would require the involvement of the CORF’s ad ministrator and a therap ist. The type of therapists at each CORF varies, depending upon th e services offered by th e facility. For the purposes of determining the burden, we will assume th at the therapist is a physical therapist. We243

expect that both the administrator and the th erapist would attend an initial meeting, review

relevant sections of the current assessmen t, develop comments and recommendations for changes, attend a follow-up meeting, perform a final review, and approve the new risk assessment. We expect that the administrato r would coordinate the meetings, review and critique the risk assessment, coordinate commen ts, develop the new risk assessment, and ensure that it was approved. We estimate that complying with this requi rement would require 8 burden hours at a cost of $485. There are currently 272 CORFs. Theref ore, it would require an estimated 2,176 burden hours (8 burden hours for each CORF x 272 CORFs = 2,176 burden hours) for all CORFs to comply at a cost of $131,920 ($485 estimated cost for each CORF x 272 CORFs = $131,920 estimated cost). After conducting the risk assessment, each CO RF would need to review, revise, and, if necessary, develop new sections for its emergenc y plan so that it complied with our proposed requirements. The current CoPs for CORFs requ ire them to have a written disaster plan (§ 485.64) that must be developed and maintained with the assistance of appropriate experts and address, among other things, procedures concer ning the transfer of casualties and records, notification of outside emergenc y personnel, and evacuation rout es (§ 485.64(a)). Thus, we expect that all CORFs have some type of em ergency preparedness pla n. However, we also expect that all CORFs would need to review, revise, and develop new sections for their plans to ensure that their plans complied with all of our proposed requirements. Based on our experience with CORFs, we expect that the admi nistrator and physical therapist who were involved in developing the risk assessment w ould be involved in developing the emergency preparedness plan. However, we expect that it would require more time to244

complete the emergency plan than to complete th e risk assessment. We estimate that complying with this requirement would require 11 bur den hours at a cost of $677 for each CORF. Therefore, it would require an estimated 2,992 burden hours (11 burden hours for each CORF x 272 CORFs = 2,992 burden hours) for all CORFs to complete an emergency preparedness plan at a cost of $184,144 ($677 estimated cost fo r each CORF x 272 CORFs = $184,144 estimated cost). The CORF also would be required to review and update its emerge ncy preparedness plan at least annually. We believe that CORFs alrea dy review their plans peri odically. Therefore, compliance with the requirement for an annual review of the emergency preparedness plan would constitute a usual and customary business practice for CORFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 485.68(b) would require CORFs to develop and implement emergency preparedness policies and procedures based on their emergency plans, risk assessments, and communication plans as set forth in § 485.68(a), (a)(1), and (c), re spectively. We would also require CORFs to review and update these policie s and procedures at l east annually. We would require that a CORF’s policies and procedures ad dress, at a minimum, the requirements listed at § 485.68(b)(1) through (4). We expect that all CORFs have some emer gency preparedness policies and procedures. As discussed earlier, the current CoPs for CO RFs already require CORFs to have "written policies and procedures that spec ifically define the handling of patients, personnel, records, and the public during disasters" (42 CFR 485.64). Howe ver, all CORFs would need to review their policies and procedures and compare them to th eir risk assessments, emergency preparedness plans, and communication plans. Most CORFs would need to re vise their existing policies and245

procedures or develop new polic ies and procedures to ensure they complied with all of our proposed requirements. We expect that both the administrator and th e therapist would attend an initial meeting, review relevant policies and procedures, make recommendations for changes, attend a follow-up meeting, perform a final review, and approve the policies and procedures. We expect that the administrator would coordinate the meetings, coor dinate the comments, and ensure that they are approved.

We estimate that it would take 9 burden hours for each CORF to comply with this requirement at a cost of $549. Therefore, it would take all CORFs 2,448 burden hours (9 burden

hours for each CORF x 272 CORFs = 2,448 burden hours) to comply wi th this requirement at a cost of $149,328 ($549 estimated cost for each CO RF x 272 CORFs = $149,328 estimated cost). Proposed § 485.68(b) also proposes that CO RFs review and update their emergency preparedness policies and procedur es at least annually. We belie ve that CORFs already review their policies and procedures periodically. Ther efore, we believe that complying with this requirement would constitute a usual and cust omary business practice fo r CORFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 485.68(c) would require CORFs to develop and maintain emergency preparedness communication plans that complied w ith both federal and stat e law and that would be reviewed and updated at le ast annually. We propose that a CORF’s communication plan include the information listed in § 485.68(c)(1) through (5). Current CoPs require CORFs to have a written disaster plan that must incl ude, among other things, "procedures for notifying community emergency personnel" (§ 486.64(a)(2)). In addition, it is standard practice in the health care industry to maintain contact information for staff and outside sources of assistance;246

alternate means of communication in case there is an interruption in phone service to the facility; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for thei r patients. However, many CORFs may not have formal, written emergency preparedness communicat ion plans. Therefore, we expect that all CORFs would need to review, update, and in some cases, develop new sections for their plans to ensure they complied with all of our proposed requirements. Based on our experience with CORFs, we anticipate that satisfying the requirements in this section would primarily re quire the involvement of the CORF’s administrator with the assistance of a physical therapist to review, revi se, and, if needed, develop new sections for the CORF’s emergency preparedness communication plan. We estimat e that it would take 8 burden hours for each CORF to comply w ith this requirement at a cost of $485. Therefore, it would take 2,176 burden hours (8 burden hours for each CORF x 272 CORFs = 2,176 burden hours) for all CORFs to comply at a cost of $131,920 ($485 estimated cost for each CORF x 272 CORFs = $131,920 estimated cost). We propose that each CORF would also have to review and update its emergency preparedness communication plan at least annua lly. We believe that compliance with this requirement would constitute a usual and cust omary business practice fo r CORFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 485.68(d) would require CORFs to develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually. We propose that each CORF would have to satis fy the requirements listed at § 485.68(d)(1) and (2).247

Proposed § 485.68(d)(1) would require that each CORF provide in itial training in emergency preparedness policies and procedures to all new and existi ng staff, individuals providing services under arrangemen t, and volunteers, consistent w ith their expected roles, and maintain documentation of the training. Ther eafter, each CORF would have to provide emergency preparedness training at least annually. Each CORF woul d also have to ensure that its staff could demonstrate knowledge of its em ergency procedures. All new personnel would have to be oriented and assigned specific res ponsibilities regarding the CORF’s emergency plan

within two weeks of thei r first workday. In addi tion, the training program would have to include instruction in the location and use of alarm sy stems and signals and fi refighting equipment. The current CORF CoPs at § 485.64 require CORFs to ensure that all personnel are knowledgeable, trained, and assigned specific responsibilities regard ing the facility’s disaster procedures. Section § 485.64(b)(1 ) specifies that CORFs must al so "provide ongoing training . . . for all personnel associated with the facility in all aspects of disaster preparedness". In addition, § 485.64(b)(2) specifies th at "all new personnel must be oriented and assigned specific responsibilities regard ing the facility’s disaster plan within 2 weeks of their first workday". In evaluating the requirement for proposed § 485.68(d)(1), we expect that all CORFs have an emergency preparedness training pr ogram for new employees, as well as ongoing training for all staff. However, under this proposed rule, all CORF s would need to compare their current training programs to their risk assessmen ts, emergency preparedness plans, policies and procedures, and communication plan s. CORFs would then need to revise, and in some cases, develop new material for th eir training programs. We expect that these tasks would require the involvement of an administrator and a physical therapist. We expect that the admini strator would review the CORF’s current training248

program to identify necessary changes and additions to the program. We expect that the physical therapist would work with the administrator to develop the revised and up dated training program. We estimate it would require 8 burden hours for e ach CORF to develop an emergency training program at a cost of $485. Therefore, for all CO RFs to comply would require an estimated 2,176 burden hours (8 burden hours for each CORF x 272 CORFs = 2,176 burden hours) at a cost of $131,920 ($485 estimated cost for each CORF x 272 CORFs = $131,920 estimated cost). We also propose that each CORF review and update its emergenc y preparedness training program at least annually. We believe that CORFs already re view their training programs periodically. Thus, complying with the require ment for an annual review of the emergency preparedness training program would constitute a usual and customary business practice for CORFs and would not be subject to the PR A in accordance with 5 CFR 1320.3(b)(2). Proposed § 485.68(d)(2) would require CORFs to participate in a community mock disaster drill and a paper-based, tabletop exerci se at least annually. If a community mock disaster drill was not available, the CORF would have to conduct an indi vidual, facility-based

mock disaster drill at least a nnually. If a CORF experienced an actual natural or man-made emergency that required activation of its emergenc y plan, it would be exempt from engaging in a community or individual, facility-based mock disa ster drill for 1 year following the onset of the

actual event. CORFs would also be required to analyze thei r responses to and maintain documentation of all drills, tablet op exercises, and emergency even ts, and revise their emergency plans, as needed. To comply with this requirem ent, a CORF would need to develop scenarios for

these drills and exercises. The current CoPs at § 485.64(b)(1) require CORFs to "provide ongoing . . . drills for all personnel associated wi th the facility in al l aspects of disaster249

preparedness". However, the current CoPs do not specify the type of drill, how often the CORF must conduct drills, or that a CORF must use scen arios for their drills and tabletop exercises. Based on our experience with CORFs, we e xpect that the same individuals who develop the emergency preparedness training program wo uld develop the scenarios for the drills and exercises, as well as the accompanying documentati on. We expect that the administrator would spend more time on these tasks than the physical th erapist. We estimate that for each CORF to comply with the proposed requirements woul d require 6 burden hours at a cost of $366. Therefore, for all 272 CORFs to comply w ould require an estimated 1,632 burden hours (6 burden hours for each CORF x 272 CORFs = 1,632 burden hours) at a cost of $99,552 ($366 estimated cost for each CORF x 272 CORFs = $99,552 estimated cost). Based on the previous analysis, for all 272 CO RFs to comply with the ICRs contained in this proposed rule would require 13,600 to tal burden hours at a total cost of $828,784.250

TABLE 11: BURDEN HOURS AND CO ST ESTIMATES FOR ALL 272 CORFS TO COMPLY WITH THE ICRs CONTAINED IN § 485.68 CONDITION: EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §485.68(a)(1) 0938-- New 272 272 8 2,176 ** 131,920 0 131,920 §485.68(a)(2- (4) 0938-- New 272 272 11 2,992 ** 184,144 0 184,144 §485.68(b) 0938-- New 272 272 9 2,448 ** 149,328 0 149,328 §485.68(c) 0938-- New 272 272 8 2,176 ** 131,920 0 131,920 §485.68(d)(1) 0938-- New 272 272 8 2,176 ** 131,920 0 131,920 §485.68(d)(2) 0938-- New 272 272 6 1,632 ** 99,552 0 99,552 Totals 272 1,632 13,600 828,784 **The hourly labor cost is blended between the wages for multiple staffing levels.

N. ICRs Regarding Condition of Partic ipation: Emergency Preparedness (§ 485.625) Proposed § 485.625(a) would require critical access hospitals (CAHs) to develop and maintain a comprehensive emergency preparedness pr ogram that utilizes an all-hazards approach and would have to be reviewed and updated at least annually. Each CAH’s emergency plan

would have to include the elements listed at § 485.625(a)(1) through (4). Proposed § 485.625(a)(1) would require each CAH to develop a documented, facilitybased and community-based risk assessment utili zing an all-hazards approach. CAHs would need to review their existing risk assessments a nd perform any tasks necessary to ensure that it complied with our proposed requirements. There are approximately 1,322 CAHs. CAHs with distinct part units were included in the hospital burden analysis. Approximately 402 CAHs are accredited either by TJC (370) or by the AOA (32); the remainder are non-accredited C AHs. Many of the TJC and AOA accreditation251

standards for CAHs are similar to the require ments in this proposed rule. For purposes of determining the burden, we have analyzed th e burden for the 370 TJC-accredited and 32 AOAaccredited CAHs separately from the non-accredite d CAHs. Note that we obtain data on the number of CAHs, both accredited and non-accred ited, from the CMS CASPER database, which 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 CAHs may not equal the total number of CAHs. For purposes of determining the burden for TJC-accredited CAHs, we used TJC’s Comprehensive Accreditation Manual for Criti cal Access Hospitals: The Official Handbook 2008 (CAMCAH). In the chapter entitled, "Manag ement of the Environment of Care" (EC), Standard EC.4.11 requires CAHs to plan for managing the consequences of emergency events (CAMCAH, Standard EC.4.11, CAMCAH Refreshe d Care, January 2008, pp. EC-10 - EC-11). CAHs are required to perform a hazard vulnerabi lity analysis (HVA), which requires each CAH to, among other things, "identify events that could affect demand for its services or its ability to provide those services, the likeli hood of those events occurring, and the consequences of those events" (Standard EC.4.11, EP 2, p. EC-10a). The HVA "should identify potential hazards, threats, and adverse events, and assess their imp act on the care, treatment, and services [the CAH] must sustain during an em ergency," and the HVA "is designed to assist [CAHs] in gaining a realistic understanding of their vulnerabilities, and to help focus their resources and planning efforts" (CAMCAH, Emergency Management, In troduction, p. EC-10). Thus, we expect that TJC-accredited CAHs already conduct a risk assessment that would comply with the requirements we propose. Thus, for the 370 TJC-accredited CAHs, the risk assessment252

requirement would constitute a usual and custom ary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). For purposes of determining the burden for AOA-accredited CAHs, we used the AOA’s

Healthcare Facilities Accredit ation Program: Accreditation Re quirements for Critical Access CAHs 2007 (ARCAH). In Chapter 11 entitled, "Phys ical Environment," CAHs are required to have disaster plans, external di saster plans that incl ude triaging victims, and weapons of mass destruction response plans (ARCAH, Standards 11.07.01, 11.07.02, and 11.07.05-6, pp. 11-38 through 11-41, respectively). In addition, AOA-accredited CAHs must "coordinate with federal, state, and local emergency preparedness and health authorities to identify likely risks for their area . . . and to develop appr opriate responses" (ARCAH, Sta ndard 11.02.02, p. 11-5). Thus, we believe that to develop their plans, AOA-accredited CAHs already perform some type of risk assessment. However, the AOA standards do no t require a documented facility-based and community-based risk assessment, as we pr opose. Therefore, we will include the 32 AOAaccredited CAHs with non-accredited CAHs in determining the burden for our proposed risk assessment requirement. The CAH CoPs currently require CAHs to a ssure the safety of th eir patients in nonmedical emergencies (§ 485.623) and to take appropriate measures that are consistent with the particular conditions in the area in which the CA H is located (42 CFR 48 5.623(c)(4)). To satisfy this requirement in the CoPs, we expect that CAHs have already conducted some type of risk assessment. However, that requirement doe s not ensure that C AHs have conducted a documented, facility-based, and community-based risk assessment that would satisfy our proposed requirements.253

We believe that under this proposed rule, the 952 non TJC-accredited CAHs (1,322

CAHs - 370 TJC-accredited CAHs = 952 non TJC- accredited CAHs) would need to review, revise, and, in some cases, develop new sections for their current risk assessments to ensure compliance with all of our requirements. We have not designated any specific proce ss or format for CAHs to use in conducting

their risk assessments because we believe that C AHs need the flexibility to determine the best way to accomplish this task. However, we expect that CAHs would include representatives from or obtain input from all of their major depart ments in the process of developing their risk

assessments. Based on our experience with CAHs, we exp ect that these activities would require the involvement of a CAH’s administrator, medical di rector, director of nursi ng, facilities director, and food services director. We expect that th ese individuals would atte nd an initial meeting,

review relevant sections of th e current risk assessment, provi de comments, attend a follow-up meeting, perform a final review, and approve the ne w or updated risk assessment. We expect the administrator would coordinate the meetings, pe rform an initial review of the current risk assessment, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approved it.

We estimate that the risk assessment re quirement would require 15 burden hours to complete at a cost of $949. We estimate that for the 952 non TJC-accredited CAHs to comply with the proposed risk a ssessment requirement would require 14,280 burden hours (15 burden

hours for each CAH x 952 non TJC-accredited C AHs = 14,280 burden hours) at a cost of $903,448 ($949 estimated cost for each non TJC-accredited CAH x 952 non TJC-accredited CAHs = $903,448 estimated cost).254

After conducting the risk assessment, CAHs would have to develop and maintain emergency preparedness plans that complied with proposed § 485.625(a)(1) through (4). We would expect all CAHs to compare their emerge ncy plans to their risk assessments and then revise and, if necessary, develop new sections for their emergency plans to ensure that they complied with our proposed requirements. The TJC-accredited CAHs must develop a nd maintain an Emergency Operations Plan (EOP) (CAMCAH Standard EC.4.12, p. EC-10a). Th e EOP must cover the management of six critical areas during emergencie s: communications, resources and assets, safety and security, staff roles and responsibilities, utilities, and patient clinical and support activities (CAMCAH, Standards EC.4.12 through 4.18, pp. EC-10a-EC-10g). In addition, as discussed earlier, TJCaccredited CAHs also are required to conduc t an HVA (CAMCAH, Standard EC.4.11, EP 2, p. EC-10a). Therefore, we expect that the 370 TJC-accredited CAHs already have emergency preparedness plans that would satisfy our proposed requirements. If a CAH needed to complete additional tasks to comply with the proposed requ irement, the burden would be negligible. Thus, for the 370 TJC-accredited CAHs, this requirement would constitute a usual and customary business practice and would not be subject to th e PRA in accordance with 5 CFR 1320.3(b)(2).

The AOA-accredited CAHs must work with federal, state, and local emergency preparedness authorities to identify the likely ri sks for their location and geographical area and develop appropriate responses to assure the safety of their patients (ARCAH, Standard 11.02.02, p. 11-5). Among the elements that AOA-accredited CAHs must specifically consider are the special needs of their patient population, availability of medical and non-medical supplies, both internal and external communications, and the transf er of patients to home or other health care settings (ARCAH, Standard 11.02.02, p. 11-5). In addition, there are requirements for disaster255

and disaster response plans (ARCA H, Standards 11.07.01, 11.07.02, and 11.07.06, pp. 11-38 through 11-40). There also are specific requireme nts for plans for respons es to weapons of mass destruction, including chemical , nuclear, and biological weapons; communicable diseases, and chemical exposures (ARCAH, Standards 11.07.02 and 11.07.05-11.07.06, pp. 11-39 through 11- 41). However, the AOA accreditation requirements require only that CAHs assess their most likely risks (ARCAH, Standard 11-02.02, p. 11-5), and we are proposing that CAHs be required

to conduct a risk assessment u tilizing an all-hazards approac h. Thus, we expect that AOAaccredited CAHs would have to compare their ri sk assessments they conducted in accordance with proposed § 485.625(a)(1) to their current plans and then re vise, and in some cases develop new sections for, their plans. Therefore, we will assess the burden for these 32 AOA-accredited

CAHs with the non-accredited CAHs. The CAH CoPs require all CAHs to ensure th e safety of their patients during non-medical emergencies (§ 485.623). They are also required to provide, among other things, for evacuation of patients, cooperation with disaster authorities, emergenc y power and lighting in their emergency rooms and for flashlights and battery lamps in other areas, an emergency water and fuel supply, and any other appropriate measures that are consistent with th eir particular location (§ 485.623). Thus, we believe that all CAHs have developed some type of emergency preparedness plan. However, we also expect that the 920 non-accredite d CAHs would have to review their current plans and co mpare them to their risk assess ments and revise and, in some cases, develop new sections for their current plan s to ensure that their plans would satisfy our proposed requirements. Based on our experience with CAHs, we e xpect that the same individuals who were involved in conducting the risk assessment would be involved in developing the emergency256

preparedness plan. We expect that these individuals would a ttend an initial meeting, review relevant sections of the current emergency preparedness plan(s), prepare and send their comments to the administrator, attend a follow- up meeting, perform a final review, and approve the new plan. We expect that the administrator would coordinate the meetings, perform an initial review, coordinate comments, revise the plan, a nd ensure that the necessary parties approve the new plan. We estimate that complying with th is requirement would require 26 burden hours at a cost of $1,620. Therefore, we estimate th at for all 952 non TJC-accredited CAHs (920

non-accredited CAHs + 32 AOA-accredited CAHs = 952 non TJC-accredited CAHs) to comply with this requirement would require 2 4,752 burden hours (26 burden hours for each non

TJC-accredited CAH x 952 non TJC-accredited C AHs = 24,752 burden hours) at a cost of $1,542,240 ($1,620 estimated cost for each non TJC- accredited CAH x 952 non TJC-accredited CAHs = $1,542,240 estimated cost). Under this proposed rule, CAHs also woul d be required to review and update their emergency preparedness plans at least annually . The CAH CoPs already require CAHs to perform a periodic evaluation of their total pr ogram at least once a year (§ 485.641(a)(1)). Hence, all CAHs should already have an individual or team responsible th at is for the periodic review of their total program. Therefore, we believe that this requirement would constitute a usual and customary business practice for CAHs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Under proposed § 485.625(b), we would requ ire CAHs to develop and maintain emergency preparedness policies and procedur es based on their emergency plans, risk assessments, and communication plans as set fort h in § 485.625(a), (a)(1), and (c), respectively. We would also require CAHs to review and update these policies and procedures at least257

annually. These policies and proced ures would have to address, at a minimum, the requirements listed at § 485.625(b)(1) through (8). We expect that all CAHs would review thei r policies and procedures and compare them to their risk assessments, emergency preparedne ss plans, and emergency communication plans. The CAHs would need to revise, and, in some cases, develop new policies and procedures to incorporate all of the provisions previously noted and address all of our proposed requirements. The CAMCAH chapter entitled, "Leadershi p" (LD), requires TJC-accredited CAH leaders to "develop policies and pr ocedures that guide and suppor t patient care, treatment, and services" (CAMCAH, Standard LC.3.90, EP 1, CAMCAH Refreshed Core, January 2008, p. LD-11). Thus, we expect that TJC-accredited C AHs already have some policies and procedures for the activities and processes required for accr editation, including their EOP. As discussed later, many of the required elements we propos e have a corresponding requirement in the CAH

TJC accreditation standards. We propose at § 485.625(b)(1) that CAHs have policies and procedures that address the provision of subsistence needs for staff and patients, whether they evacuate or shelter in place. TJC-accredited CAHs must make plans for obtai ning and replenishing medical and non-medical supplies, including food, water, and fuel for gene rators and transportation vehicles (CAMCAH, Standard EC.4.14, EPs 1-4, p. EC-10d). In additi on, they must identify alternative means of providing electricity, water, fuel , and other essential utility ne eds in cases where their usual supply is disrupted or compro mised (CAMCAH, Standard EC .4.17, EPs 1-5, p. EC-10f). We expect that TJC-accredited CAHs that comply w ith these requirements would be in compliance with our proposed requirement concerni ng subsistence needs at § 485.625(b)(1).258

We are proposing at § 485.625(b)(2) that CAHs have policies and procedures for a system to track the location of staff and patie nts in the CAH’s care both during and after an emergency. TJC-accredited CAHs must plan for communicating with their staff, as well as patients and their families, at the beginning of and during an emergency (CAMCAH, Standard EC.4.13, EPs 1, 2, and 5, p. EC-10c). We expect th at TJC-accredited CAHs that comply with these requirements would be in compliance with our proposed requirement. Proposed § 485.625(b)(3) would require CAHs to have a plan for the safe evacuation from the CAH. TJC-accredited CAHs are required to make plans to evacuate patients as part of managing their clinical activities (CAMCAH, Standard EC.4.18, EP 1, p. EC-10g). They also must plan for the evacuation and transport of pa tients, their information, medications, supplies, and equipment to altern ative care sites (ACSs) when the CAH cannot provide care, treatment, and services in its facility (CAMCAH, Standa rd EC.4.14, EPs 9-11, p. EC-10d) . We expect that TJC-accredited CAHs that comply with these re quirements would be in compliance with our proposed requirement. We are proposing at § 485.625(b)(4) that CAHs have policies and procedures for a means to shelter in place for patients, staff, and volunteers who remain in the facility. The rationale for CAMCAH Standard EC.4.18 states, "[a] catastrophic emergency ma y result in the decision to keep all patients on the premises in the intere st of safety" (CAMCAH, Standard EC.4.18, p. EC10f). Therefore, we expect that TJC-accredited CAHs would be substantially in compliance with our proposed requirement. Proposed § 485.625(b)(5) would require CAHs to have policies and procedures that address a system of medical do cumentation that preserves patie nt information, protects the confidentiality of patient information, and ensures that records are secure and readily available.259

The CAMCAH chapter entitled "Management of In formation" (IM), requires TJC-accredited CAHs to have storage and retr ieval systems for their clinical/service and CAH-specific information (CAMCAH, Standard IM.3.10, EP 5, CAMCAH Refreshed Core, January 2008, p. IM-11), as well as to ensure the c ontinuity of their critical information for patient care, treatment, and services (CAMCAH, Standard IM.2.30, CAMC AH Refreshed Core, January 2008, p. IM-9). They also must ensure the privacy and conf identiality of patient information (CAMCAH, Standard IM.2.10, CAMCAH Refreshed Core, Ja nuary 2008, p. IM-7). In addition, TJCaccredited CAHs must have plans for transporting patients and their clinical information, including transferring information to ACSs (CAMCAH Standard EC.4.14, EP 10 and 11, p. EC10d and Standard EC.4.18, EP 6, pp. EC-10g, respectiv ely). Therefore, we expect that TJCaccredited CAHs would be substantially in compliance with proposed § 485.625(b)(5). Proposed § 485.625(b)(6) would require CAHs to have policies and procedures that

addressed the use of volunteers in an emergency or other emerge ncy staffing strategies. TJCaccredited CAHs must define staff roles and respons ibilities in their EOP and ensure that they

train their staff for their a ssigned roles (CAMCAH, Standard EC.4.16, EPs 1 and 2, p. EC-10e). Also, the rationale for Standard EC.4.15 indicate s that the CAH "determines the type of access and movement to be allowed by . . . emergency volunteers . . . when emergency measures are initiated" (CAMCAH, Standard EC.4.15, Rationale , p. EC-10d). In addition, in the chapter entitled "Medical Staff" (MS), CAHs "may grant di saster privileges to volunteers that are eligible to be licensed independent practitioners" (CAMCAH, Standard MS.4.110, CAMCAH Refreshed Care, January 2008, p. MS-20). Finally, in th e chapter entitled "Management of Human Resources" (HR), CAHs "may assign disaster responsibilities to volunteer practitioners" (CAMCAH, Standard HR.1.25, CAMCAH Refreshe d Core, January 2008, p. HR-6). Although260

the TJC accreditation requirements address some of our proposed requirements, we do not

believe TJC-accredited CAHs would be in co mpliance with all requi rements in proposed § 485.625(b)(6). Based upon the previous discussion, we expect that the activities re quired for compliance by TJC-accredited CAHs with § 485.625(b)(1) thr ough (b)(5) constitutes usual and customary business practices for PRAs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). However, we do not believe TJC-accredited CAHs would be substantially in compliance with proposed § 485.625(b)(6) through (8). We will discuss the burden for TJC-accredited CAHs to comply with these requirements later in this section.

The AOA accreditation standards also contai n requirements for policies and procedures related to safety and disaster preparedness. The AOA-accredited C AHs are required to maintain plans and performance standards for disa ster preparedness (A RCAH, Standard 11.00.02 Required Plans and Performance Standards, p. 11-2). They also must have "written procedures for possible situations to be followed by each de partment and service within the CAH and for each building used for patient treatment or hous ing" (ARCAH, Standard 11.07.01 Disaster Plans, Explanation, p.11-38). AOA-accredited CAHs also are required to have a safety team or committee that is responsible for all issues rela ted to safety within the CAH (ARCAH, Standard 11.02.03, p. 11-7). The individuals or team would be responsible for all policies and procedures related to safety in the CAH (ARCAH, Standard 11.02.03, Explanation, p. 11-7). We expect that these performance standards and procedures are similar to some of our proposed requirements for policies and procedures.261

In regard to proposed § 485.625(b)(1), AOA-accr edited CAHs are required to consider "pharmaceuticals, food, other supplies and equipment that may be needed during emergency/disaster situations" and "provisions if gas, water, electr icity supply is shut off to the community" when they are developing thei r emergency plans (ARCAH, Standard 11.02.02 Building Safety, Elements 5 and 11, pp. 11-5 and 11-6, respectively). In addition, CAHs are required "to provide emergency gas and water as needed to provide care to inpatients and other persons who may come to the CAH in need of care" (ARCAH, Standard 11.03.22 Emergency Gas and Water, p. 11-22 through 11-23). However, these standards do not specifically address all of the proposed requirements in this subsection. In regard to proposed § 485.625(b)(2), AOA-accr edited CAHs are required to consider how they will communicate with their staff within the CAH when developing their emergency plans (ARCAH, Standard 11.02.02 Building Safety, El ement 7, p. 11-6). They also are required

to have a "call tree" in their external disaster plan that mu st be updated at least annually (ARCAH, Standard 11.07.04 Staff Call Tree, p. 11 -40). However, these requirements do not sufficiently cover the requirements to track the lo cation of staff and patie nts during and after an

emergency. In regard to proposed § 485.625(b)(3), which requires policies and pr ocedures regarding the safe evacuation from the facility, AOA-accred ited CAHs are required to consider the "transfer or discharge of patie nts to home, other healthcare se ttings, or other CAHs" and the "transfer of patients with CAH equipment to another CAH or healthca re setting" (ARCAH, Standard 11.02.02 Building Safety, Elements 12 and 13, p. 11-6). AOA-accredited CAHs also are required to consider in their emergency plan s how to maintain communication with external entities should their telephones and computers e ither cease to operate or become overloaded262

(ARCAH, Standard 11.02.02, Element 6, p. 11-6). AOA-accredited CAHs must also "develop and implement a comprehensive plan to ensure that the safety and well being of patients are assured during emergency situations" (ARC AH, Standard 11.02.02 Building Safety, pp. 11-4 through 11-7). However, we do not believe thes e requirements are detailed enough to ensure that AOA-accredited CAHs are compliant with our proposed requirements. In regard to proposed § 485.625(b)(4), AOA-accr edited CAHs are required to consider the special needs of their patient population and the security of those patients and others that come to them for care when they develop their emergency plans (ARCAH, Standard 11.02.02 Building Safety, Elements 2 and 3, p. 11-5). In addition, as described ear lier, they also must consider the food, pharmaceuticals, and other supp lies and equipment they may need during an emergency in developing their emergency plan (ARCAH, Standard 11.02.02, Element 5, p. 11- 5). However, these requirements do not specif ically mention volunteers and CAHs are required only to consider these elements in developing their plans. Therefore, we believe that AOA-accredited CAHs have likel y already incorporated many of the elements necessary to satisfy the requirements in proposed § 485.625(b); however, they would need to thoroughly review their current policie s and procedures and perform whatever tasks are necessary to ensure that they comp lied with all of our proposed requirements for emergency policies and procedures. Because we expect that AOA-accr edited CAHs already comply with many of our proposed requirement s, we will include the AOA-accredited CAHs with the TJC-accredited CAHs in determining the burden.

The burden for the 32 AOA-accredited CAHs and the 370 TJC-accredited CAHs to comply with all of the requirements in proposed § 485.625(b) would be the resources required to develop written policies and procedures that co mply with all of our proposed requirements for263

emergency policies and procedures. Based on our experience working with CAHs, we expect that accomplishing these activities would requir e the involvement of an administrator, the medical director, director of nur sing, facilities director , and food services di rector. We expect that the administrator would review the policie s and procedures and make recommendations for necessary changes or additional policies or procedures. The CAH administrator would brief other staff and assign staff to ma ke necessary revisions or draft new policies and procedures and disseminate them to the appropriate parties. We estimate that complying with this requirement would require 10 burden hours for each TJC and AOA-accredited CAH at a cost of $624. For all 402 TJC and AOA-accredited CAHs to comply with these requirements would require an estimated 4,020 burden hours (10 burden hour s for each TJC or AOA-accredited CAH x 402 TJC and AOA-accredited CAHs = 4,020 burden hours) at a cost of $327,228 ($814 estimated

cost for each TJC or AOA-accredited CAH x 402 TJC and AOA- accredited CAHs = $327,228 estimated cost). We expect that the 920 non-accredited CAHs already have developed some emergency preparedness policies and procedures. The current CAH CoPs require CAHs to develop, maintain, and review policies to ensure quality care and a safe environment for their patients (§ 485.627(a), § 485.635(a), and § 485.641(a)(1)(iii)). In addition, certain ac tivities associated with our proposed requirements ar e addressed in the current CAH CoPs. For example, all CAHs are required to have agreements or arrangements with one or more providers or suppliers, as appropriate, to provide services to their patients (§ 485.635(c)). The burden associated with the developm ent of emergency policies and procedures

would be the resources needed to review, revise, and if needed, develop emergency preparedness policies and procedures that incl ude our proposed requirements. We believe the individuals and264

tasks would be the same as described earlier for the TJC and AOA-accredited CAHs. However, the non-accredited CAHs would require more time to accomplish these activities. We estimate that a non-accredited CAH’s comp liance would require 14 burden hours at a cost of $860. For all 920 unaccredited CAHs to comply with this requirement would require an estimated 12,880 burden hours (14 burden hours for each non-accredited CAHs x 920 non-accredited CAHs = 12,880 burden hours) at a cost of $791,200 ($860 estim ated cost for each non-accredited CAH x 920 non-accredited CAHs = $791,200 estimated cost). Thus, for all 1,322 CAH to comply with the requirements in proposed § 485.625(b) would require 16,900 burden hours at a cost of $1,118,428. Proposed § 485.625(b) would al so require CAHs to review and update their emergency preparedness policies and procedures at leas t annually. As discu ssed earlier, TJC and AOAaccredited CAHs already periodically review thei r policies and procedures. In addition, the existing CAH CoPs require periodic reviews of the CAH’s health car e policies (§ 485.627(a), § 485.635(a), and § 485.641(a)(1)(iii)). Thus, complian ce with this requirem ent would constitute a usual and customary business practice for all C AHs and would not be s ubject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 485.625(c) would require CAHs to develop and maintain emergency preparedness communication plans that complied with both federal and state law. We propose that CAHs review and update these plans at least annua lly. We propose that these communication plans include the informa tion listed at § 485.625( c)(1) through (7). We expect that all CAHs would review their emergency prep aredness communication plans and compare them to their risk assessments and emergency plans. We also expect that CAHs would revise and, if n ecessary, develop new sections that would comply with our265

proposed requirements. Based on our experience w ith CAHs, they generally have some type of emergency preparedness communica tion plan. Further, it is sta ndard practice for health care

facilities to maintain contact information for both staff and outside sources of assistance;

alternate means of communications in case there is an interruption in phone service to the facility; and a method for sharing information a nd medical documentation w ith other health care providers to ensure continuity of care for their pa tients. Thus, we believe that most, if not all, CAHs are already in compliance with proposed § 485.625(c)(1) through (3). However, all CAHs would need to review a nd, if needed, revise and update their plans to ensure compliance with proposed § 485.625(c)(4) through (7). The TJC-accredited CAHs are required to establish strategies or plans fo r emergency communications (CAMCAH, Standard 4.13, p. EC-10b -10c). These plans must cover bot h internal and external communications and include back-up techno logies and communication systems (CAMCAH, Standard 4.13, and EPs 1-14, p. EC-10b-EC-10c). However, we do not believe that these standards would ensurecompliance with proposed § 485.625(c)(4) through (7). Thus, we will include the 365 TJCaccredited CAHs in the burden below. The AOA-accredited CAHs must develop and implement communication plans to ensure the safety of their patients during emerge ncies (AOA Standard 11.02.02). These plans must specifically include both in ternal and external communi cations (AOA Standard 11.02.02, Elements 6, 7, and 10). Based on these standard s, we do not believe they ensure compliance with proposed § 485.625(c)(4) thro ugh (7). Thus, we will include these 32 AOA-accredited

CAHs in the burden below. The burden associated with complying with this requirement would be the resources required to develop a communication plan that co mplied with the requirements of this section.266

Based on our experience with CAHs, we expect that accomplishing these activities would require the involvement of an administrator, director of nursing, and the facilities director. We expect

that the administrator would review the comm unication plan and make recommendations for necessary changes or additions. The director of nursing and the facilities director would meet

with the administrator to disc uss and revise or draft new s ections for the CAH’s existing emergency communication plan. We estimate th at complying with this requirement would require 9 burden hours for each CAH at a cost of $519. We estimate that for all 1,322 CAHs to comply with the requirements for an emergenc y preparedness communication plan would require 11,898 burden hours (9 burden hours for each C AH x 1,322 CAHs = 11,898 burden hours) at a cost of $686,118 ($519 estimated cost for each C AH x 1,322 CAHs = $686,118 estimated cost). Proposed § 485.625(c) also would require CAHs to review and update their emergency preparedness communication plans at least annuall y. All CAHs are required to evaluate their entire program at least annually (§ 485.641(a)). Therefore, co mpliance with this requirement would constitute a usual and customary business practice for CAHs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 485.625(d) would require CAHs to develop and maintain emergency preparedness training and testing programs. We would also require CAHs to review and update their training and testing programs at least annua lly. We propose that a CAH comply with the requirements listed at § 485.625(d)(1) and (2). Regarding § 485.625(d)(1), CAHs would have to provide initial training in emergency preparedness policies and procedures, includ ing prompt reporting a nd extinguishing fires, protection, and where necessary, ev acuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all ne w and existing staff,267

individuals providing services under arrangement, and volunteers, c onsistent with their expected roles, and maintain documentation of the training. Thereafter, the CAH would have to provide emergency preparedness tr aining at least annually. We expect that all CAHs would review th eir current training programs and compare them to their risk assessments and emergency prepar edness plans, emergency policies and procedures, and emergency communication plans. The CAHs would need to revise and, if necessary, develop new sections or materials to ensure th eir training and testing programs complied with our proposed requirements. Current CoPs require CAHs to train th eir staffs on how to handle emergencies (§ 485.623(c)(1)). However, this training primaril y addresses internal em ergencies, such as a fire inside the facility. In addition, both TJC and AOA require C AHs to provide their staff with training. TJC-accredited CAHs are required to provide their staff with both an initial orientation and on-going training (CAMCAH, Sta ndards HR.2.10 and 2.30, pp. HR-8 and HR—9, respectively). On-going traini ng must also be documented (CAMCAH, Standard HR.2.30, EP 8, p. HR-10). The AOA-accredited CAHs are required to provide an education program for their staff and physicians for the CAH’s emergenc y response preparedness (AOA Standard 11.07.01). Each CAH also must provide an education program specifically for the CAH’s response plan for weapons of mass destructi on (AOA Standard 11.07.07). Thus, we expect that all CAHs provide so me emergency preparedness training for their staff. However, neither the current CoPs nor the TJC and AOA accreditation standards ensure compliance with all our proposed requirements. All CAHs would need to review their risk assessments, emergency preparedness plans, po licies and procedures, and communication plans and then revise or, in some cases, develop new sections for their training programs to ensure268

compliance with our proposed requirements. They also would need to revise, update, or, in some cases, develop new materials for th e initial and ongoing training. Based on our experience with CAHs, we expect that complying with our proposed requirement would require the involvement of an administrator, the director of nursing, and the facilities director. We expect that the director of nursing would perform th e initial review of the training program, brief the administ rator and the director of facili ties, and revise or develop new sections for the training program, based on the group’s decisions. We estimate that each CAH would require 14 burden hours to develop an emer gency preparedness traini ng program at a cost of $834. Therefore, for all 1,322 CAHs to comply with this requirement would require an estimated 18,508 burden hours (14 burden hours for each CAH x 1,322 CAHs = 18,508 burden hours) at a cost of $1,102,548 ($834 estimated cost for each CAH x 1,322 CAHs = $1,102,548 estimated cost). Proposed § 485.625(d)(1) also would require CAHs to review and update their emergency preparedness training programs at le ast annually. Existing re gulations require all CAHs to evaluate their entire program at leas t annually (§ 485.641(a)). Therefore, compliance with this proposed requirement would constitu te a usual and customary business practice for CAHs and would not be subject to the PR A in accordance with 5 CFR 1320.3(b)(2). The CAHs also would be required to main tain documentation of their training. Based on our experience with CAHs, it is standard practice for them to document the training they provide

to staff and other individuals. If a CAH needed to make any changes to their normal business practices to comply with this requirement, the burden would be negligible. Thus, compliance with this requirement would constitute a usua l and customary business practice for CAHs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).269

Proposed § 485.625(d)(2) would require CAHs to participate in a community mock disaster drill and a paper-based, tabletop exerci se at least annually. If a community mock disaster drill was not available, the CAH would have to conduct an individual, facility-based

mock disaster drill at least annually. CAHs also would be required to analyze the CAH’s response to and maintain documentation of all dril ls, tabletop exercises, and emergency events, and revise the CAH’s emergency plan, as needed . If a CAH experienced an actual natural or man-made emergency that required activation of the emergency plan, it would be exempt from the proposed requirement for an annual community or individual, facility-based mock disaster drill for 1 year following the onset of the em ergency (proposed § 485.625(d )(2)(ii)). Thus, to meet these requirements, CAHs would need to de velop scenarios for each drill and exercise and develop the required documentation. If a CAH participated in a community mock disaster drill, it w ould likely not need to develop the scenario for that drill. However, for the purpose of determining the burden, we will assume that CAHs need to develop scenario s for both the drill and the exercise annually. The TJC-accredited CAHs are required to test their EOP twice a year, either as a planned exercise or in response to an emergency (C AMCAH, Standard EC.4.20, EP 1, p. EC-12). These tests must be monitored, documented, and an alyzed (CAMCAH, Standard EC.4.20, EPs 8-19, pp. EC-12 – EC-13). Thus, we believe that TJ C-accredited CAHs already develop scenarios for these tests. We also expect that they also ha ve developed the documentation necessary to record and analyze their tests and res ponses to actual emergency events. Therefore, compliance with this requirement would constitu te a usual and customary busine ss practice for TJC-accredited CAHs and would not be subject to the PR A in accordance with 5 CFR 1320.3(b)(2).270

The AOA-accredited CAHs are required to conduct two disaster drills annually (AOA Standard 11.07.03). In addition, AOA-accredited CAHs are required to participate in weapons of mass destruction drills, as appropriate (AOA Standard 11.0 7.09). We expect that since AOA-accredited CAHs already conduct di saster drills, they also deve lop scenarios for the drills. In addition, it is standard practi ce in the health care industry to document and analyze tests that a facility conducts. Thus, comp liance with this requirement would constitute a usual and customary business practice for AOA-accredited CAHs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Based on our experience with CAHs, we expect that the 831 non-accredited CAHs already have some type of emergency prepare dness training program and conduct some type of

drills or exercises to test thei r emergency preparedness plans. Ho wever, this does not ensure that most CAHs already perform the activities needed to comply with our proposed requirements. Thus, we will analyze the burden for these requirements for the 920 non-accredited CAHs. The 920 non-accredited CAHs would be requi red to develop scenarios for a mock disaster drill and a paper-based, tabletop exercise and the documen tation necessary to record and later analyze the events that occurred during these tests and actual emergency events. Based on our experience with CAHs, we believe that the same individuals who developed the emergency preparedness training program would develop th e scenarios for the tests and the accompanying documentation. We expect that the director of nursing would spend more time than would the other individuals developing the scenarios a nd the accompanying documentation. We estimate that it would require 8 burden hours for the 920 non-accredited CAHs to comply with these proposed requirements at a cost of $488. Therefor e, for all 920 non-accredited CAHs to comply with these requirements would require an es timated 7,360 burden hours (8 burden hours for each271

non-accredited CAH x 920 non-accredited CAHs = 7,360 burden hours) at a cost of $448,960 ($488 estimated cost for each non-accredi ted CAH x 920 non-accredited CAHs = $448,960 estimated cost).

TABLE 12: BURDEN HOURS AND COST ESTIMATES FOR ALL 1,322 CAHS TO COMPLY WITH THE ICRs CONTAINE D IN § 485.625 CONDITION: EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §485.625(a)(1) 0938- New 952 952 15 14,280 ** 903,448 0 903,448 §485.625(a)(2)- (4) 0938- New 952 952 26 24,752 ** 1,542,240 0 1,542,240 §485.625(b) (TJC andAOAAccredited) 0938- New 402 402 10 4,020 **

327,228 0 327,228 §485.625(b)(Nonaccredited) 0938- New 920 920 14 12,880 ** 791,200 0 791,200 §485.625(c) 0938- New 1322 1322 9 11,898 ** 686,118 0 686,118 §485.625(d)(1) 0938- New 1322 1322 14 18,508 ** 1,102,548 0 1,102,548 §485.625(d)(2) 0938- New 920 920 8 7,360 ** 448,960 0 448,960 Total 6,790 93,698 5,801,742 ** The hourly labor cost is blended between th e wages for multiple staffing levels. O. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 485.727) Proposed § 485.727(a) would require clinics, rehabilitation agencies , and public health agencies as providers of outpa tient physical therapy and spee ch-language pathology services (organizations) to develop and maintain emergency preparedne ss plans and review and update the plan at least annually. We are proposing that the plan comply with the requirements listed at § 485.727(a)(1) through (6). Proposed § 485.727(a)(1) would require organi zations to develop documented, facilitybased and community-based risk assessment utili zing an all-hazards approach. Organizations272

would need to identify the medical and non-medi cal emergency events they could experience

both at their facilities an d in the surrounding area. The current CoPs for Organiza tions require these providers to have "a written plan in operation, with procedures to be followed in th e event of fire, explos ion, or other disaster" (§ 485.727(a)). To comply with this CoP, we ex pect that all of these providers have already performed some type of risk assessment during th e process of developing th eir disaster plans and policies and procedures. However, these provide rs would need to review their current risk assessments and make any revisions to ensure th ey complied with our proposed requirements. We have not designated any specific process or format for these providers to use in conducting their risk assessments because we believ e that they need the flexibility to determine the best way to accomplish this task. Providers of physical therapy and speech therapy services should include input from all of their major depa rtments in the process of developing their risk assessments. Based on our experience with thes e providers, we expect that conducting the risk assessment would require the involvement of the organization’s administrator and a therapist. The types of therapists at each Organization vary depending upon the services offered by the facility. For the purposes of determining the PRA burden, we will assume that the therapist is a physical therapist. We expect that both the admi nistrator and the therapis t would attend an initial meeting, review the current asse ssment, develop comments and recommendations for changes to the assessment, attend a follow- up meeting, perform a final revi ew, and approve the new risk assessment. We expect that the administrato r would coordinate the meetings, review and critique the current risk assessment initially, offer suggested revisions , coordinate comments, develop the new risk assessment, and ensure that the necessary parties approve it. We also expect that the administrator would spend more time reviewing and working on the risk273

assessment than the physical therap ist. We estimate that complyi ng with this requirement would require 9 burden hours at a cost of $549. We estimate that it would require 20,034 burden hours (9 burden hours for each organization x 2,256 organizations = 20,304 burden hours) for all organizations to comply with this requirem ent at a cost of $1,238,544 ($549 estimated cost for each organization x 2,256 organizations = $1,238,544 estimated cost). After conducting the risk assessment, each organization would need to develop and maintain an emergency preparedness plan and re view and update it at least annually. Current CoPs require these providers to have a written disaster plan with accompanying procedures for fires, explosions, and other disasters (§ 485.727(a )). The plan must include or address the

transfer of casualties an d records, the location an d use of alarm systems and signals, methods of containing fire, notification of appropriate pe rsons, and evacuation routes and procedures (§ 485.727(a)). Thus, we expect th at all of these organizations have some type of emergency preparedness plan and that these plans address many of our proposed requirements. However, all organizations would need to review their cu rrent plans and compare them to their risk assessments. Each organization would need to revise, update, and, in some cases, develop new sections to complete a comprehensive emergenc y preparedness plan that complied with our proposed requirements. Based on our experience with these organiza tions, we expect that the administrator and physical therapist who were involved in develo ping the risk assessment would be involved in developing the emergency preparedness plan. Howe ver, we expect it woul d require more time to complete the plan and that the administrator w ould be the most heavily involved in reviewing and developing the organization’s emergency pr eparedness plan. We estimate that for each organization to comply would require 12 burden hours at a cost of $741. We estimate that it274

would require 27,072 burden hours (12 burden hours for each organization x 2,256 organizations = 27,072 burden hours) to complete the plan at a cost of $1,671,696 ($741 estimated cost for each organization x 2,256 organizations = $1,671,696 estimated cost). Each organization would also be requ ired to review and update its emergency preparedness plan at least annua lly. We believe that these orga nizations already review their plans periodically. Thus, complying with th is requirement would c onstitute a usual and customary business practice for organizations and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 485.727(b) would requi re organizations to develop and implement emergency preparedness policies and procedures based on their risk assessments, emergency plans, communication plans as set forth in § 485.727(a)(1), (a), and (c), respectively. It would also require organizations to review and update these policies and proce dures at least annually. At a minimum, we would require that an organi zation’s policies and procedures address the requirements listed at § 485.727(b)(1) through (4). We expect that all organizations have em ergency preparedness policies and procedures. As discussed earlier, the current CoPs require organizations to have procedures within their written disaster plan to be followed for fires, explosions, or other disasters (§ 485.727(a)). In addition, we expect that those pr ocedures already address some of the specific elements required in this section. For example, the current requirements at § 485.727(a)(1) through (4) are similar to our proposed requirements at § 485.727(a)(1) thr ough (5). However, all organizations would need to review their policies and procedures , assess whether their pol icies and procedures incorporate all of the necessary elements of their emergency preparedness program, and, if275

necessary, take the appropriate steps to ensure that their policies a nd procedures are in compliance with our proposed requirements. We expect that the administrator and the physical therapist would be primarily involved with reviewing and revising the current policies and procedures and, if needed, developing new policies and procedures. We estimate that it would require 10 burden hours for each organization to comply at a cost of $613. We estim ate that for all organizations to comply would require 22,560 burden hours (10 burden hours fo r each organization x 2,256 organizations = 23,550 burden hours) at a cost of $1,382,928 ($622 es timated cost for each organization x 2,256 organizations = $1,382,928 estimated cost). We would require organizat ions to review and update their emergency preparedness policies and procedures at least annually. We be lieve that these providers already review their emergency preparedness policies and procedures pe riodically. Therefore, compliance with this requirement would constitute a usual and custom ary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 485.727(c) would requi re organizations to develop and maintain emergency preparedness communication plans that complied with both federal and st ate law and would be reviewed and updated at least annually. The co mmunication plan would have to include the information listed at § 485.727(c)(1) through (5). We expect that all organizations have some type of emergency preparedness communication plan. Current CoPs for these or ganizations already require them to have a written disaster plan with pro cedures that must include, among other things, "notification of appropriate persons" (§ 485.727(a)(4)). Thus, we expect that each organization has the contact information they would need to comply with this proposed requirement . In addition, it is276

standard practice for health care facilities to maintain contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the facility ; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care fo r their patients. However, many organizations may not have formal, written emergency preparedness communication plans or their plans may not be fully compliant with our proposed requirements. Therefore, we expect that all organizations would need to review, update, and, in some cases, develop new sections for their plans. Based on our experience with these organi zations, we anticipate that satisfying the requirements in this section would primarily require the involvement of the organization’s

administrator with the as sistance of a physical therapist. We estimate that for each organization to comply would require 8 burden hours at a cost of $494. We estimate that for all 2,256 organizations to comply would require 18,048 burden hours (8 burden hours for each organizations x 2,256 organizations = 18,048 burden hours) at a cost of $1,114,464 ($494 estimated cost for each organization x 2,256 organizations = $1,114,464 estimated cost). We are proposing that organizations must review and update their emergency preparedness communication plans at least annually. We believe that these organizations already review their emergency communication plans periodically. Thus, compliance with this requirement would constitute a usual and custom ary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 485.727(d) would requi re organizations to develop and maintain emergency preparedness training and testing programs a nd review and update th ese programs at least277

annually. Specifically, we are prop osing that organizations comply with the requirements listed at § 485.727(d)(1) and (2). With respect to § 485.727(d)(1), organizations would have to provide initial training in emergency preparedness policies and procedures to all new and existi ng staff, individuals providing services under arrangemen t, and volunteers, consistent w ith their expected roles, and maintain documentation of the training. Thereafte r, the CAH would have to provide emergency preparedness traini ng at least annually. Current CoPs require organizations to ensure that "all employees ar e trained, as part of their employment orientation, in all aspects of preparedness for any disaster. The disaster program includes orientation and ongoing training and drills for all personnel in all procedures . . . "(42 CFR 485.727(b)). Thus, we expect that organizations already have an emergency preparedness training program for new employ ees, as well as ongoing training for all staff. However, organizations would need to review their current training programs and compare them to their risk assessments and emergency prep aredness plans, policies and procedures, and communication plans. Organizations would need to review, revise, and, in some cases, develop new material for their training programs so that they comply with our proposed requirements. We expect that complying with this requi rement would require the involvement of an administrator and a physical therap ist. We expect that the ad ministrator would primarily be involved in reviewing the orga nization’s current training program and the current emergency preparedness program; determining what tasks w ould need to be performed and what materials would need to be developed to comply with our proposed requirement s; and developing the materials for the training program. We expect that the physical therapist would work with the administrator to develop the revised and updated tr aining program. We estimate that it would278

require 8 burden hours for each organization to develop a comprehensive emergency training program at a cost of $494. Therefore, it would require an esti mated 18,048 burden hours (8 burden hours for each organization x 2,256 or ganizations = 18,048 burden hours) to comply with this requirement at a cost of $1,114,464 ( $494 estimated cost for each organization x 2,256 organizations = $1,114,464 estimated cost). In § 485.727(d)(1), we also propose requiring that an organization must review and update its emergency preparedness training progra m at least annually. We believe that these providers already review their emergency prepar edness training programs periodically. Thus, compliance with this requirement would constitu te a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 485.727(d)(2) would require organi zations to participate in a community mock disaster drill and a paper-b ased, tabletop exercise at leas t annually. If a community mock disaster drill was not available, the organizati on would have to conduct an individual, facilitybased mock disaster drill at least annually. If an organization experien ced an actual natural or man-made emergency that required activation of its emergency plan, it would be exempt from engaging in a community or indivi dual, facility-based mock disast er drill for 1 year following the onset of the actual event. Organi zations also would be required to analyze their response to and maintain documentation of all the drills, tabletop exercises, and emergency events, and revise their emergency plan, as needed. To comply w ith this requirement, an organization would need to develop scenarios for their dri lls and exercises. An organiza tion also would have to develop the documentation necessary for recording and analyz ing their responses to drills, exercises, and actual emergency events.279

The current CoPs require organizations to have a written disa ster plan that is "periodically rehearsed" and have "ongoing . . . dr ills" (§ 485.727(a) and (b )). Thus, we expect that all 2,256 organizations currently conduct some type of drill or exercise of their disaster plan. However, the current organizations CoPs do not sp ecify the type of drill, how they are to conduct the drills, or whether th e drills should be commu nity-based. In addition, there is no requirement for a paper-based, tabletop exercise. Thus, thes e requirements do not ensure that organizations would be in compliance with our proposed require ments. Therefore, we will analyze the burden from these requirements for all organizations. The 2,256 organizations would be required to de velop scenarios for a mock disaster drill and a paper-based, tabletop exercise and the ne cessary documentation. Based on our experience with organizations, we expect that the sa me individuals who develop the emergency preparedness training program would develop the scenarios for the drills and exercises and the accompanying documentation. We expect that the administrator would spend more time than the physical therapist developing th e scenarios and the documentati on. We estimate that for each organization to comply would require 3 burden hour s at a cost of $183. Ba sed on that estimate, it would require 6,768 burden hours (3 burden ho urs for each organization x 2,256 organizations = 6,768 burden hours) at a cost of $417,360 ($183 es timated cost for each organization x 2,256 organizations = $417,360 estimate cost).

TABLE 13: BURDEN HOURS A ND COST ESTIMATES FOR ALL 2,256 ORGANIZATIONS TO COMPLY WITH THE ICRs CONTAINED IN § 485.727 CONDITION: EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §485.727(a)(1) 0938- New 2,256 2,256 9 20,304 ** 1,238,544 0 1,238,544 §485.727(a)(2)- 0938- 2,256 2,256 12 27,072 ** 1,671,696 0 1,671,696280

(4) New §485.727(b) 0938- New 2,256 2,256 10 22,560 ** 1,382,928 0 1,382,928 §485.727(c) 0938- New 2,256 2,256 8 18,048 ** 1,114,464 0 1,114,464 §485.727(d)(1) 0938- New 2,256 2,256 8 18,048 ** 1,114,464 0 1,114,464 §485.727(d)(2) 0938- New 2,256 2,256 3 6,768 ** 417,360 0 417,360 Totals 2,256 13,536 112,800 6,939,456 ** The hourly labor cost is blended between the wages for multiple staffing levels.

P. ICRs Regarding Condition of Partic ipation: Emergency Preparedness (§ 485.920) Proposed § 485.920(a) would require Community Mental Health Centers (CMHCs) to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. Specifically, we propose that th e plan must meet the requirements listed at § 485.920(a)(1) through (4). We expect all CMHCs to identify the likel y medical and non-medical emergency events they could experience within the facility and the community in wh ich it is located and determine the likelihood of the facility expe riencing an emergency due to the identified hazards. We expect that in performing the risk assessment, a CMHC would need to consider its physical location, the geographical area in which it is located and its patient population. The burden associated with this proposed requirement would be the time and effort necessary to perform a thorough risk assessment. We expect that most, if not all, CMHCs have already performed at least some of the work need ed for a risk assessment because it is standard practice for health care organizations to prep are for common emergencies, such as fires, interruptions in communication and power, and storms. However, many CMHCs may not have performed a risk assessment that complies with the proposed requirements. Therefore, we expect that most, if not all, CMHCs would have to perform a thorough review of their current281

risk assessment and perform the tasks necessary to ensure that the facility’s risk assessment complies with the proposed requirements. We do not propose designati ng any specific process or format for CMHCs to use in conducting their risk assessments because we believe CMHCs need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we expect that in the process of developing a risk assessment, health care organizations would include representatives from or obtain i nput from all major departments. Based on our experience with CMHCs, we expect that conducti ng the risk assessment would re quire the involvement of the CMHC administrator, a psychiatric registered nurse, and a clinical social worker or mental health counselor. We expect that most of these indi viduals would attend an initial meeting, review relevant sections of the current assessment, prepare and forward their comments to the administrator, attend a follow-up meeting, perf orm a final review, and approve the risk assessment. We expect that the administrato r would coordinate the meetings, do an initial review of the current risk assessment, critique the risk assessment, offer suggested revisions, coordinate comments, develop the new risk asse ssment, and assure that the necessary parties approve the new risk assessment. It is likely that the CMHC administ rator would spend more time reviewing and working on the risk assessment th an the other individuals. We estimate that complying with the proposed requirement to conduct a risk assessment would require 10 burden hours for a cost of $470. There are currently 207 CMHCs. Therefore, it would require an estimated 2,070 burden hours (10 burden hours for each CMHC x 207 CMHCs = 2,070 burden hours) for all CMHCs to comply with this requirement at a cost of $97,290 ($470 estimated cost for each CMHC x 207 CMHCs = $97,290 estimated cost).282

After conducting the risk assessment, CMHCs would need to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. CMHCs would need to compare their current emergency pla n, if they have one, to their risk assessment. They would then need to revise and, if necessary, develop new sections of their plan to ensure it complies with the proposed requirements. It is standard practice for health care or ganizations to make plans for common disasters they may confront, such as fire s, interruptions in communicati on and power, and storms. Thus, we expect that all CMHCs have some type of em ergency preparedness plan. However, their plan may not address all likely medical and non-medi cal emergency events identified by the risk assessment. Further, their plans may not incl ude strategies for addr essing likely emergency events or address their patient popul ation, the type of services they have the ability to provide in an emergency, or continuity of operation, incl uding delegations of authority and succession plans. We expect that CMHCs would have to re view their current plan and compare it to their risk assessment, as well as to the other requ irements in proposed § 485.920(a). We expect that most CMHCs would need to update and revise thei r existing emergency plan and, in some cases, develop new sections to comply w ith our proposed requirements. The burden associated with this requirement would be due to the resources needed to develop an emergency preparedness plan or to review, revise, a nd develop new sections for an existing emergency plan. Based upon our experien ce with CMHCs, we expect that the same

individuals who were involved in the risk assessment would be involved in developing the emergency preparedness plan. We also expect that developing the plan would require more time to complete than the risk assessment. We exp ect that the administrator and a psychiatric nurse would spend more time reviewing and developi ng the CMHC’s emergency preparedness plan.283

We expect that the clinical social worker or me ntal health counselor wo uld review the plan and provide comments on it to the administrator. We estimate that it would require 15 burden hours for a CMHC to develop its emerge ncy plan at a cost of $750. Ba sed on this estimate, it would require 3,105 burden hours (15 burden hour s for each CMHC x 207 CMHCs = 3,105 burden hours) for all CMHCs to complete their plans at a cost of $155,250 ($750 estimated cost for each CMHC x 207 CMHCs = $155,250 estimated cost). The CMHC would be required to review a nd update its emergency preparedness plan at least annually. For the purpose of determini ng the burden for this proposed requirement, we expect that the CMHCs will review and update their plans annually. We expect that all CMHCs have an administ rator that is responsible for the day-to-day operation of the CMHC. This would include ensu ring that all of the CM HC’s plans are up-todate and comply with the relevant federal, state, and local laws, regulati ons, and ordinances. In addition, it is standard practice in the health care industry for faci lities to have a professional staff person, generally an administrator, who pe riodically reviews their plans and procedures. We expect that complying with the requireme nt for an annual review of the emergency preparedness plan would consti tute a usual and customary busin ess practice for CMHCs. As stated in 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessa ry to comply with a

collection of information that would be incurr ed by persons in the normal course of their activities are not subject to the PRA. Proposed § 485.920(b) would require CMHCs to develop and maintain emergency preparedness policies and procedures based on the emergency plan, the communication plan, and the risk assessment. We also propose requiring CMHCs to review and u pdate these policies and284

procedures at least annually. The CMHC’s pol icies and procedures would be required to address, at a minimum, the requireme nts listed at § 485.920(b)(1) through (7). We expect that all CMHCs would compare th eir current emergency preparedness policies and procedures to their emergency preparedne ss plan, communication pl an, and their training and testing program. They would need to review , revise and, if necessa ry, develop new policies and procedure to ensure they comply with the proposed requirements. The burden associated with reviewing, revising, and updating the CMHC ’s emergency policies and procedures would

be due to the resources needed to ensure they comply with the proposed requirements. We expect that the administrator and the psychiatric registered nurse would be involved with reviewing, revising and, if neede d, developing any new policies a nd procedures. We estimate that for a CMHC to comply with this proposed requirement would requi re 12 burden hours at a cost of $630. Therefore, for all 207 CMHCs to comply with this proposed requirement would require an estimated 2,484 burden hours (12 burden hours for each CMHC x 207 CMHCs = 2,484 burden hours) at a cost of $130,410 ($630 estim ated cost for each CMHC x 207 CMHCs = $130,410 estimated cost). The CMHCs would be required to review and update their emergency preparedness policies and procedures at least annually. For the purpose of determining the burden for this requirement, we expect that CMHCs would review their policies and procedures annually. We expect that all CMHCs have an administrator who is responsible for the da y-to-day operation of the CMHC, which includes ensuring that all ofthe CMHC’s policies and procedures are up-todate and comply with the relevant federal, state, and local laws, regulations, and ordinances. We also expect that the administrator is respons ible for periodically reviewing the emergency preparedness policies and procedures as part of his or her responsibilitie s. We expect that285

complying with the requirement for an annual re view of the emergency preparedness policies and procedures would constitute a usual and customary business practice for CMHCs. As stated in 5 CFR 1320.3(b)(2), the time, effort, and fina ncial resources necessary to comply with a

collection of information that would be incurr ed by persons in the normal course of their activities are not subject to the PRA. Proposed § 485.920(c) would require CMHCs to develop and maintain an emergency preparedness communications plan that complies with both federal and state law. The CMHC also would have to review and update this plan at least annually. The communication plan must

include the information listed in § 485.920(c)(1) through (7). We expect that all CMHCs would comp are their current emergency preparedness communications plan, if they have one, to the proposed requirements. CMHCs would need to perform any tasks necessary to ensure that their communication plans were documented and in compliance with the proposed requirements. We expect that all CMHCs have some t ype of emergency prep aredness communications plan. However, their emergency communications plan may not be thoroughly documented or comply with all of the elements we are requiri ng. It is standard pr actice for health care organizations to maintain contact information for their staff and for outside sources of assistance;

alternate means of communication in case there is a disruption in phone service to the facility (for example, cell phones); and a method for sh aring information and medical documentation with other health care providers to ensure continuity of care fo r their patients. However, we expect that all CMHCs would need to review, update, and in so me cases, develop new sections for their plans to ensure that those plans include all of the elements we are requiring for CMHC communications plans.286

The burden associated with complying with this proposed requirement would be due to the resources required to ensure that the CMHC ’s emergency communication plan complies with the requirements. Based upon our experience with CMHCs, we e xpect the involvement of the CMHC’s administrator and the psychiatric regist ered nurse. For each CMHC, we estimate that complying with this requirement would require 8 burden hours at a cost of $415. Therefore, for all of the CMHCs to comply with this propos ed requirement would require an estimated 1,656 burden hours (8 burden hours for each CMHC x 207 CMHCs = 1,656 burden hours) at a cost of $85,905 ($415 estimated cost for each CMHC x 207 CMHCs = $85,905 estimated cost). We expect that CMHCs must also revi ew and update their emergency preparedness communication plan at least annually. For th e purpose of determining the burden for this proposed requirement, we expect that CMHCs would review their policies and procedures annually. We expect that all CMHCs have an ad ministrator who is responsible for the day-today operation of the CMHC. This includes en suring that all of the CMHC’s policies and procedures are up-to-date and comply with the relevant federal, st ate, and local laws, regulations, and ordinances. We expect that the administrator is responsibl e for periodically reviewing the CMHC’s plans, policies, and procedures as part of his or her responsibilities. In addition, we expect that an annual review of the communication plan would re quire only a negligible burden. Complying with the proposed requirement for an annual review of the emergency preparedness communications plan constitutes a usual and custom ary business practice for CMHCs. As stated in 5 CFR 1320.3(b)(2), the time, effort, and fina ncial resources necessary to comply with a

collection of information that would be incurr ed by persons in the normal course of their activities are not subject to the PRA.287

Proposed § 485.920(d) would require CMHCs to develop and maintain an emergency preparedness training program that must be re viewed and updated at le ast annually. We would require the CMHC to meet the requirements contained in § 485.920(d)(1) and (2). We expect that CMHCs would develop a comprehensive emergency preparedness training program. The CMHCs would need to compare their current emergency preparedness training program and compare its contents to the risk asse ssment and updated emergency preparedness plan, policies and procedures, and communications plan and review, revise, and, if necessary, develop new sections for their traini ng program to ensure it complies with the proposed requirements.

The burden would be due to the resources the CMHC would need to comply with the proposed requirements. We expect that comply ing with this requirement would include the involvement of a psychiatric regi stered nurse. We expect that the psychiatric registered nurse would be primarily involved in reviewing the CMHC’s current training program, determining what tasks need to be performed or what mate rials need to be developed, and developing the materials for the training program. We estimate that it would require 10 burden hours for each CMHC to develop a comprehensive emergency trai ning program at a cost of $414. Therefore, it would require an estimated 2,070 burden hours (1 0 burden hours for each CMHC x 207 CMHCs = 2,070 burden hours) to comply with this pr oposed requirement at a cost of $85,698 ($414 estimated cost for each CMHC x 207 CMHCs = $85,698 estimated cost). Proposed § 485.920(d)(1) would also require the CMHCs to review and update their emergency preparedness training program at leas t annually. For the purpose of determining the burden for this proposed requirement, we will exp ect that CMHCs would review their emergency preparedness training program annu ally. We expect that all CM HCs have a professional staff288

person, probably a psychiatric registered nurse, who is responsible for periodically reviewing their training program to ensure th at it is up-to-date and complies wi th the relevant federal, state, and local laws, regulations, and or dinances. In addition, we expect that an annual review of the CMHC’s emergency preparedness training progra m would require only a negligible burden. Thus, we expect that complying with the propos ed requirement for an annual review of the emergency preparedness training program constitutes a usual and customary business practice

for CMHCs. As stated in 5 CF R 1320.3(b)(2), the time, effort, a nd financial resources necessary to comply with a collection of information th at would be incurred by persons in the normal course of their activities are not subject to the PRA. Proposed § 485.920(d)(2) would require CMHCs to participate in or conduct a mock disaster drill and a paper-based, tabletop exercise at least annu ally. CMHCs would be required

to document the drills and the exercises. To comply with this proposed requirement, a CMHC would need to develop a specific scenario for e ach drill and exercise. A CMHC would have to develop the documentation necessary to record what happened during the drills and exercises. Based on our experience with CMHCs, we exp ect that all 207 CMHCs have some type of emergency preparedness training program and most, if not all, of these CMHCs already conduct some type of drill or exercise to test their em ergency preparedness plans. However, we do not know what type of drills or exer cises they typically conduct or how often they are performed. We also do not know how, or if, they are docum enting and analyzing their responses to these drills and tests. For the purpose of determin ing a burden for these proposed requirements, we will expect that all CMHCs need to develop tw o scenarios, one for the drill and one for the exercise, and develop the documentation necessary to record the facil ity’s responses.289

The associated burden would be the time and effort necessary to comply with the requirement. We expect that complying with th is proposed requirement would likely require the involvement of a psychiatric regi stered nurse. We expect that the psychiatric registered nurse would develop the documentation necessary for bot h during the drill and the exercise and for the subsequent analysis of the CMHC’s response. The psychiatric registered nurse would also develop the two scenarios for the drill and exercise. We estimate that these tasks would require 4 burden hours at a cost of $166. For all 207 CMHCs to comply with this proposed requirement would require an estimated 828 burden hours (4 burden hours for each CMHC x 207 CMHCs = 828 burden hours) at a cost of $34,362 ($166 esti mated cost for each CMHC x 207 CMHCs = $34,362 estimated cost).

TABLE 14: BURDEN HOURS AND CO ST ESTIMATES FOR ALL 207 CMHCs TO COMPLY WITH THE ICRs CO NTAINED IN § 485.920 EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Cost

($) §485.920(a)(1) 0938- New 207 207 10 2,070 ** 97,290 97,290 §485.920(a)(1)- (4) 0938- New 207 207 15 3,105 ** 155,250 155,250 §485.920(b) 0938- New 207 207 12 2,484 ** 130,410 130,410 §485.920(c) 0938- New 207 207 8 1,656 ** 85,905 85,905 §485.920(d)(1) 0938- New 207 207 10 2,070 ** 85,698 85,698 §485.920(d)(2) 0938- New 207 207 4 828 ** 34,362 34,362 Totals 207 1,242 12,213 588,915 Q. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 486.360)290

Proposed § 486.360(a) would require Organ Procurement Organizations (OPOs) to develop and maintain emergency preparedness plan s that would have to be reviewed and updated at least annually. These pl ans would have to comply w ith the requirements listed in § 486.360(a)(1) through (4). The current OPO Conditions for Coverage (CfCs) are located at 42 CFR 486.301 through

486.348. These CfCs do not contain any specific emergency preparedness requirements. Thus, for the purpose of determining the burden, we ha ve analyzed the burden for all 58 OPOs for all of the ICRs contained in this proposed rule. Proposed § 486.360(a)(1) would require OPOs to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. OPOs would need to identify the medical and non-medical emergency events they could experience both at their

facilities and in the su rrounding area, including branch offi ces and hospitals in their donation

services areas. The burden associated with this requirement would be the time and effort necessary to perform a thorough risk assessment. Based on our experience with OPOs, we believe that all 58 OPOs have already performed at least some of the work needed for their risk assessments. However, these risk assessments may not be docum ented or may not address all of the elements required under proposed § 486.360(a). Therefore, we expect that all 58 OPOs would have to perform a thorough review of thei r current risk assessments and perform the necessary tasks to ensure that their risk assessment complied with th e requirements of this proposed rule. Based on our experience with OPOs, we believe that c onducting a risk assessm ent would require the involvement of the OPO’s director, medical director, quality assessment and performance improvement (QAPI) director, and an organ procur ement coordinator (OPC). We expect that291

these individuals would attend an initial meeting; review relevant sections of the current assessment, prepare and send their comments to the QAPI director; attend a follow-up meeting; perform a final review; and approve the new ri sk assessment. We estimate that the QAPI Director probably would coordinate the meetings, review the current risk assessment, critique the risk assessment, coordinate comments, develop the new risk assessment, and assure that the necessary parties approved it. We estimate th at it would require 10 burden hours for each OPO to conduct a risk assessment at a cost of $822. Therefore, for all 58 OPOs to comply with the risk assessment requirement in this section would require an estimated 580 burden hours (10 burden hours for each OPO x 58 OPOs = 580 burden hours) at a cost of $47,676 ($822 estimated cost for each OPO x 58 OPOs = $47,676 estimated cost). After conducting the risk assessment, OPOs would then have to develop emergency preparedness plans. The burden associated with this requirement would be the resources needed to develop an emergency preparedness plan that complied with the requirements in proposed § 486.360(a)(1) through (4). We expect that all OPOs have some type of emergency preparedness plan because it is standard practice in the health care industry to have a plan to address common emergencies, such as fires. In addition, based on our experience with OPOs (including the performance of the Louisiana OP O during the Katrina disaster), OPOs already have plans to ensure that servic es will continue to be provide d in their donation service areas (DSAs) during an emergency. However, we do not expect that all OPOs would have emergency preparedness plans that would satis fy the requirements of this sect ion. Therefore, we expect that

all OPOs would need to review their current emergency preparedness plans and compare their plans to their risk assessments. Most OPOs wo uld need to revise, and in some cases develop, new sections to ensure their plan satisfied the proposed requirements.292

We expect that the same i ndividuals who were involved in the risk assessment would be involved in developing the emerge ncy preparedness plan. We e xpect that these individuals would attend an initial meeting, review releva nt sections of the OPO’s current emergency preparedness plan, prepare a nd send their comments to the QAPI director, attend a follow-up meeting, perform a final review, and approve the new plan. We expect that the QAPI Director would coordinate the meetings, perform an initial review of the current emergency preparedness plan, critique the emergency preparedness pl an, coordinate commen ts, ensure that the appropriate individuals revise th e plan, and ensure that the ne cessary parties approve the new plan. Thus, we estimate that it would require 22 burden hours for each OPO to develop an emergency preparedness plan that complied with th e requirements of this section at a cost of $1,772. Therefore, for all 58 OPOs to comply with this requirement would require an estimated 1,276 burden hours (22 burden hours for each OPO x 58 OPOs = 1,276 burden hours) at a cost of $102,776 ($1,772 estimated cost for each OPO x 58 OPOs = $102,776 estimated cost). OPOs would also be required to review a nd update their emergency preparedness plans at least annually. We believe that all of the OP Os already review their emergency preparedness plans periodically. Thus, compliance with th is requirement would constitute a usual and customary business practice for OPOs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 486.360(b) would require OPOs to develop and maintain emergency preparedness policies and procedures based on their risk assessments, emergency preparedness plans, emergency communication plan as set fo rth in proposed § 486.360(a)(1), (a), and (c), respectively. It would also require OPOs to re view and update these policies and procedures at293

least annually. The OPO’s policies and procedur es must address the requirements listed at § 486.360(b)(1) and (2). The OPO CfCs already require the OPOs ’ governing boards to "develop and oversee implementation of policies and procedures consid ered necessary for the effective administration of the OPO, including . . . th e OPO’s quality assessment and performance improvement (QAPI) program, and services furnished under contract or arrangement, including agreements for those services" (§ 486.324(e)). Thus, we expect that OPOs already have developed and implemented policies and procedures for their effective administration. However, since the current CfCs have no specific requirement that these policies and pr ocedures address emergency preparedness, we

do not believe that the OPOs have developed or implemented all of the policies and procedures that would be needed to comply with the requirements of this section. The burden associated with the development of the emergency preparedness policies and procedures would be the res ources needed to develop emer gency preparedness policies and procedures that would include, but would not be limited to, the specific elements identified in this requirement. We expect that all OPOs wo uld need to review thei r current policies and procedures and compare them to their risk assessments, emergency preparedness plans, emergency communication plans, and agreements and protocols, they have developed as required by this proposed rule. Following thei r reviews, OPOs would need to develop and implement the policies and procedures necessary to ensure that they initia te and maintain their emergency preparedness plans, agreements, and protocols. Based on our experience with OPOs, we e xpect that accomplishing these activities would require the involvement of the OPO’s director, medical director, QAPI director, and an Organ Procurement Coordinator (OPC). We expect th at all of these indivi duals would review the294

OPO’s current policies and procedures; compar e them to the risk assessment, emergency preparedness plan, agreements and protocols they have established with hospitals, other OPOs, and transplant programs; provide an analysis or comments; a nd participate in developing the final version of the policies and procedures. We expect that the QAPI director would lik ely coordinate the mee tings; coordinate and incorporate comments; draft the revised or new policies and pro cedures; and obtain the necessary signatures for final approval. We estimate that it would require 20 burden hours for each OPO to comply with the requirement to develop emerge ncy preparedness policies and procedures at a cost of $1,482. Therefore, for all 58 OPOs to co mply with this requirement would require an estimated 1,160 burden hours (20 burden hours for each OPO x 58 OPOs = 1,160 burden hours) at a cost of $85,956 (estimated cost for each OPO of $1,482 x 58 OPOs = $85,956 estimated cost). OPOs also would be required to review a nd update their emergency preparedness policies and procedures at least annually. We believ e that OPOs already review their emergency preparedness policies and procedures periodicall y. Therefore, compliance with this requirement

would constitute a usual and cust omary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 486.360(c) would require OPOs to develop and maintain emergency preparedness communication plans that complied with both federal and state law. The OPOs would have to review and update their plans at least annually. The communication plans would

have to include the information listed in § 486.360(c)(1) through (3). OPOs must operate 24 hours a day, seven days a week. OPOs conduct much of their work away from their office(s) at various hospita ls within their DSAs. To function effectively,295

OPOs must ensure that they and their staff at these multiple locations can communicate with the OPO’s office(s), other OPO staff members, transplant and donor hospitals, transplant programs, the Organ Procurement and Transplantation Networ k (OPTN), other healthcare providers, other OPOs, and potential and act ual donors’ next-of-kin. Thus, we expect that the nature of their wo rk would ensure that all OPOs have already

addressed at least some of the el ements that would be required by this section. For example, due to the necessity of communication with so many other entities, we expect that all OPOs would have compiled names and contact information for staff, other OPOs, and transplant programs. We also expect that all OPOs would have alternate m eans of communication for their staffs. However, we do not believe that all OPOs have developed formal pl ans that include all of the proposed elements contained in this requirem ent. The burden would be the resources needed to develop an emergency preparedness communi cations plan that woul d include, but not be limited to, the specific elements identified in this section. We expect that this would require the involvement of the OPO director, medical director, QAPI director, a nd OPC. We expect that all

of these individuals would need to review the OPO’s current plans, polic ies, and procedures related to communications and compare them to the OPO’s risk assessment, emergency plan, and the agreements and protocols the OPO developed in accordance with proposed § 486.360(e), and the OPO’s emergency preparedness policies and pro cedures. We expect that these individuals would review the materials described earlier, submit comments to the QAPI director, review revisions and additions, and gi ve a final recommendation or approval for the new emergency preparedness communication plan. We also expect that the QAPI director would coordinate the meetings; compile comments; incorporate comm ents into a new communications plan, as appropriate; and ensure that the necessary in dividuals review and approve the new plan.296

We estimate that it would require 14 burden hours to develop an emergency preparedness communication plan at a cost of $1,078. Therefor e, it would require an estimated 812 burden hours (14 burden hours for each OPO x 58 OPOs = 812 burden hours) at a cost of $62,524 ($1,078 estimated cost for each OPO x 58 OPOs = $62,524 estimated cost). We propose that OPOs must review and update their emergency preparedness communication plans at least annua lly. We believe that all of the OPOs already review their emergency preparedness communication plans pe riodically. Thus, compliance with this requirement would constitute a usual and cust omary business practice for OPOs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 486.360(d) would require OPOs to develop and maintain emergency preparedness training and testing programs. OPOs also would be required to review and update these programs at least annually. In addition, OPOs must meet the requirements listed in § 486.360(d)(1) and (2). In § 486.360(d)(1), we are proposing that OPOs be required to provide initial training in emergency preparedness policies and procedures to all new and existi ng staff, individuals providing services under arrangemen t, and volunteers, consistent w ith their expected roles, and maintain documentation of that training. OPOs must also ensure that their staff can demonstrate knowledge of their emergency procedures. Thereaf ter, OPOs would have to provide emergency preparedness training at least annually. Under existing regulations, OPOs are required to provide their staffs with the training and education necessary for them to furnish the se rvices the OPO is required to provide, including applicable organizational policies and procedur es and QAPI activities (§ 486.326(c)). However, since there are no specific emergency preparedne ss requirements in the current OPO CfCs, we297

do not believe that the content of their exis ting training would comply with the proposed requirements. We expect that OPOs would develop a co mprehensive emergency preparedness training program for their staffs. Based upon our experien ce with OPOs, we expect that complying with this proposed requirement would require the OPO director, medical direct or, the QAPI director, an OPC, and the education coordi nator. We expect that the QAPI director and the education

coordinator would review the OPO’s risk assess ment, emergency preparedness plan, policies and procedures, and communication plan and make recommendations regard ing revisions or new sections necessary to ensure that all appropriate information is included in the OPO’s emergency preparedness training. We believe that the OPO director, medical director, and OPC would meet with the QAPI director and edu cation coordinator and assist in the review, provide comments, and approve the new emergency pr eparedness training program. We estimate that it would require 40 burden hours for each OPO to develop an emergency preparedness training program that co mplied with these requirements at a cost of $2,406. Therefore, we estimate that for all 58 OP Os to comply with this requirement would require 2,320 burden hours (40 burden hours fo r each OPO x 58 OPOs = 2,320 burden hours) at a cost of $139,548 ($2,406 estimated cost for each OPO x 58 OPOs = $139,548 estimated cost). We propose that OPOs must review and upda te their emergency preparedness training programs at least annually. We believe that a ll of the OPOs already review their emergency preparedness training programs periodically. Ther efore, compliance with this requirement would

constitute a usual and customar y business practice for OPOs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).298

Proposed § 486.360(d)(2) would require OPOs to conduct a paper-based, tabletop exercise at least annually. OPOs also would be required to analyze their responses to and maintain documentation of all tabletop exercises and actual emergency events, and revise their emergency plans, as needed. To comply with this requirement, OPOs would have to develop scenarios for each tabletop exercise and the necessary documentation. The OPO CfCs do not currently contai n a requirement for OPOs to conduct a paper-based, tabletop exercise. However, OPOs are required to evaluate their staffs’ performance and provide traini ng to improve individual and ov erall staff performance and effectiveness (42 CFR 486.326(c)). Therefore, we expect that OPOs periodically conduct some type of exercise to test their plans, policies, and procedures, which w ould include developing a scenario for and documenting the exercise. T hus, compliance with these requirements would

constitute a usual and customar y business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). We expect that the QAPI director and the e ducation coordinator woul d work together to develop the scenario for the exercise and the ne cessary documentation. We expect that the QAPI director would likely spend more time on these ac tivities. We estimate that these tasks would require 5 burden hours for each OPO at a cost of $278. For all 58 OPOs to comply with these requirements would require an estimated 290 bu rden hours (5 burden hours for each OPO x 58 OPOs = 290 burden hours) at a cost of $16,124 ($278 estimated cost for each OPO x 58 OPOs = $16,124 estimated cost). Proposed § 486.360(e) would require each OPO to have an agreement(s) with one or more other OPOs to provide e ssential organ procurement servi ces to all or a portion of the OPO’s DSA in the event that the OPO cannot provide such services due to an emergency. This299

section would also require each OPO to include in the hospital agreements required under § 486.322(a), and in the protocols with tran splant programs required under § 486.344(d), the duties and responsibilities of the hospital, transplant program, and the OPO in the event of an

emergency. The burden associated with the development of an agreement with another OPO and with the hospitals in the OPO’s DSA would be the reso urces needed to negotiate, draft, and approve the agreement. For the purpose of determining a burden for this requirement, we will assume that each OPO would need to develop an agreement with one other OPO. We expect that the OPO director, medical di rector, QAPI director, OPC, and an attorney would be involved in completing the tasks necess ary to develop these agreements. We expect

that all of these individuals w ould be involved in assessing the OPO’s need for coverage of its DSA during emergencies and deciding with which OPO to negotiate an agreement. We also expect that the OPO director, QAPI director, and an attorney would be involved in negotiating the agreements and ensuring that the appropriate parties sign the agreements. The attorney would be responsible for drafting the agr eement and making any necessary revisions. We estimate that it would require 22 burden hours for each OPO to develop an agreement with another OPO to provide esse ntial organ procurement services to all or a portion of its DSA during an emergency at a cost of $1,658. Theref ore, it would require an estimated 1,276 burden hours (22 burden hours for each OPO x 58 OPOs = 1,276 burden hours) for all 58 OPOs to comply with this requirement at a cost of $96,164 ($1,658 estimated cost for each OPO x 58 OPOs = $96,164 estimated cost). Proposed § 486.360(e) would also require OPOs to include in the agreements with hospitals required under § 486.322(a), and in the protocols with transplant programs required300

under § 486.344(d), the duties and res ponsibilities of the hospital, tr ansplant center, and the OPO in the event of an emergency. The current OPO CfCs do not contain a requirement for emergency preparedness to be covered in these agreements and protocols. However, based on our experience with OPOs, hospitals, and transplant centers, we expect that most, if not all of these agreements and protocols already address roles and responsibilities during an emergency. Thus, for the purpose of determining an ICR burden for these requirements, we will

assume that all 58 OPOs would need to draf t a limited amount of new language for their agreements with hospitals and the protocols with transplant centers. We expect that an attorney would be primarily responsible for drafting the language for these agreements and protocols and making any necessary revisions requ ired by the parties. The number of hospitals and transplant programs in each DSA would vary widely between the OPOs. However, we expect that the attorney would draft standard la nguage for both types of documents. In addition, we expect that the OPO director, medical direct or, QAPI director, and OPC would work with the attorney in developing this standard language. We estimate that it would require 13 burde n hours for each OPO to comply with these requirements at a cost of $969. Therefore, it would require 754 burden hours (13 burden hours for each OPO x 58 OPOs = 754 burden hours) at a cost of $56,202 ($969 estimated cost for each OPO x 58 OPOs = $56,202 estimated cost). Based on the previous analysis, for all 58 OP Os to comply with all of the ICRs in proposed § 486.360 would require 8,468 burden hours at a cost of $606,970.

TABLE 15: BURDEN HOURS AND COST ESTIMATES FOR ALL 58 OPOS TO COMPLY WITH THE ICRs CONTAINE D IN § 486.360 CONDITION: EMERGENCY PREPAREDNESS301

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §486.360(a)(1) 0938-New 58 58 10 580 ** 47,676 0 47,676 §486.360(a)(2)-(4) 0938-New 58 58 22 1,276 ** 102,776 0 102,776 §486.360(b) 0938-New 58 58 20 1,160 ** 85,956 0 85,956 §486.360(c) 0938-New 58 58 14 812 ** 62,524 0 62,524 §486.360(d)(1) 0938-New 58 58 40 2,320 ** 139,548 0 139,548 §486.360(d)(2) 0938-New 58 58 5 290 ** 16,124 0 16,124 §486.360(e) 0938-New 58 58 35 2,030 ** 152,366 0 152,366 Totals 58 406 146 8,468 606,970

R. ICRs Regarding Condition of Participat ion: Emergency Prep aredness (§ 491.12) Proposed § 491.12(a) would require Rural Health Clinics (RHCs) and Federally Qualified Health Clinics (FQHCs) to develop and maintain emergency preparedness plans. The RHCs and FQHCs would also have to review and update their plan s at least annually. We propose that the plan must meet the requirements listed at § 491.12(a )(1) through (4). Proposed § 491.12(a)(1) would require RH Cs/FQHCs to develop a documented, facility-based and community-based risk as sessment utilizing an all-hazards approach. RHCs/FQHCs would need to identify the medical and non-medical emergency events they could experience both at their facilities and in th e surrounding area. RHCs /FQHCs would need to review any existing risk assessments and then up date and revise those assessments or develop

new sections for them so that those assessmen ts complied with our proposed requirements. We obtained the total number of RHCs and FQ HCs used in this burden analysis from the CMS CASPER data system, which the states upda te periodically. Due to variations in the timeliness of the data submission, all numbers in this analysis are ap proximate. There are currently 4,013 RHCs and 5,534 FQHCs. Thus , there are 9,547 RHC/FQHCs (4,013 RHCs + 5,534 FQHCs = 9,547 RHCs/FQHCs). Unlike RHCs, FQHCs are grantees under Section 330 of the Public Health Service Act. In 2007, the Health Resources and Services Administration302

(HRSA) issued a Policy Information Notice (PIN) entitled "Health Center Emergency Management Program Expectations," that deta iled the expectations HRSA has for section 330 grantees related to emergency management (" Health Center Emergency Management Program Expectations," Policy Information Noti ce (PIN), Document Number 2007-15, HRSA, August 22, 2007) (Emergency Management PIN). A review of the Emergency Management PIN indicates that some of its expect ations are very similar to the re quirements in this proposed rule. Therefore, since the expectations in the Emerge ncy Management PIN are a significant factor in determining the burden for FQHCs, we will anal yze the burden for the 5,534 FQHCs separately from the 4,013 RHCs where the burden would be significantly different. Based on our experience with RHCs, we expect that all 4,013 RHCs have already performed at least some of the work needed to co nduct a risk assessment. It is standard practice for health care facilities to prepare for common emergencies, such as fires, power outages, and storms. In addition, the current Rural Health C linic Conditions for Certification and the FQHC Conditions for Coverage (RHC/FQHC CfCs) alre ady require each RHC and FQHC to assure "the safety of patients in cas e of non-medical emergencies by . . . taking other appropriate measures that are consistent with the particular conditions of the area in which the clinic or

center is located" (§ 491.6(c)(3)). Further, in accordance with the Emerge ncy Management PIN, FQHCs should have initiated their "emergency management planning by conducting a risk assessment such as a Hazard Vulnerability Analysis" (HVA) (Emergen cy Management PIN, p. 5). The HVA should identify potential emergencies or risks and potential direct and i ndirect effects on the facility’s operations and demands on their services and prio ritize the risks based on the likelihood of each risk occurring and the impact or severity the facility would experience if the risk occurs303

(Emergency Management PIN, p. 5). FQHCs are also "encouraged to pa rticipate in community level risk assessments and integrate their ow n risk assessment with the local community" (Emergency Management PIN, p. 5). Despite these expectations and the existi ng Medicare regulations for RHCs/FQHCs, some RHC/FQHC risk assessments may not comply with all proposed requirement s. For example, the expectations for FQHCs do not specifically addr ess our proposed requireme nt to address likely medical and non-medical emergencies. In addi tion, participation in a community-based risk assessment is only encouraged, not required. We expect that all 4,013 RHCs and 5,534 FQHCs will need to compare their cu rrent risk assessments with our proposed requirements and accomplish the tasks necessary to ensure their risk assessments comply with our proposed requirements. However, we expect that FQHCs would not be subject to as many burden hours as

RHCs. We have not designated any specific process or format for RHCs or FQHCs to use in conducting their risk assessments because we beli eve that RHCs and FQHCs need flexibility to determine the best way to accomplish this task. However, we expect that these health care facilities would include input from all of their ma jor departments. Based on our experience with RHCs/FQHCs, we expect that conducting the risk assessment would require the involvement of the RHC/FQHC’s administrator, a physician, a nurse practitioner or physician assistant, and a registered nurse. We expect that these indivi duals would attend an ini tial meeting, review the current risk assessment, prepare and forward th eir comments to the administrator, attend a follow-up meeting, perform a final re view, and approve the new risk assessment. We expect that the administrator would coordinate the meetings, review the current risk assessment, provide an analysis of the risk assessment, offer suggested revisions, coordinate co mments, develop the new304

risk assessment, and ensure that the necessary parties approve it. We also expect that the administrator would spend more time reviewing the risk assessmen t than the other individuals. We estimate that it would require 10 bur den hours for each RHC to conduct a risk assessment that complied with the requirements in this section at a co st of $712. We estimate that for all RHCs to comply with our propos ed requirements would require 40,130 burden hours (10 burden hours for each RHC x 4,013 RHCs = 39,410 burden hours) at a cost of $2,857,256 ($712 estimated cost for each RHC x 4,013 RHCs = $2,857,256 estimated cost). We estimate that it would require 5 burd en hours for each FQHC to conduct a risk assessment that complied with our proposed requirem ents at a cost of $356. We estimate that for all 5,534 FQHCs to comply would require 27,670 burden hours (5 burden hours for each FQHC x 5,534 FQHCs = 27,670 burden hours) at a cost of $1,970,104 ($356 estimated cost for each FQHC x 5,534 FQHCs = $1,970,104 estimated cost). Based on those estimates, compliance with this proposed requirement for all RHCs and FQHCs would require 67,800 bur den hours at a cost of $4,827,360. After conducting the risk assessment, RHCs/F QHCs would have to develop and maintain emergency preparedness plans that complie d with proposed § 491.12(a)(1) through (4) and review and update them annually. It is standard practice for hea lthcare facilities to plan for common emergencies, such as fires, hurricanes, and snowstorms. In addition, as discussed earlier, we require all RHCs/FQHCs to take appropriate measures to ensure the safety of their patients in non-medical emergencies, based on th e particular conditions present in the area in which they are located (§ 491.6(c)(3)). Thus, we expect that all RHCs/FQHCs have developed some type of emergency preparedness pla n. However, under this proposed rule, all RHCs/FQHCs would have to review their curr ent plans and compare them to their risk305

assessments. The RHCs/FQHCs would need to u pdate, revise, and, in some cases, develop new sections to complete their emergency preparedne ss plans that meet our proposed requirements. The Emergency Management PIN contains ma ny expectations for an FQHC’s emergency management plan (EMP). For example, it states that the FQHC’s EMP "is necessary to ensure the continuity of patient care" during an emergency (Emergency Management PIN, p. 6) and should contain plans for "assuring access for spec ial populations (Emergency Management PIN, p. 7). The FQHC’s EMP also should address continuity of operations, as appropriate (Emergency Management PIN, p. 6). In additio n, FQHCs should use an "all-hazards approach" so that these facilities can respond to all of the risks they identi fied in their risk assessment (Emergency Management PIN, p. 6). Based on the expectations in the Emergency Management PIN, we expect that FQHCs likely have develo ped emergency preparedness plans that comply with many, if not all, of the elements with whic h their plans would need to comply under this proposed rule. However, we expect that FQHC s would need to compare their current EMP to our proposed requirements and, if necessary, revise or develop new sections for their EMP to bring it into compliance. We expect that F QHCs would have less of a burden than RHCs. Based on our experience with RHCs/FQHCs, we expect that the same individuals who were involved in developing the risk assessm ents would be involved in developing the emergency preparedness plans. However, we exp ect that it would require more time to complete the plans than the risk assessments. We exp ect that the administrator would have primary responsibility for reviewing and developing th e RHC/FQHC’s EMP. We expect that the physician, nurse practitioner, and registered nur se would review the draft plan and provide

comments to the administrator. We estimate that for each RHC to comply with this requirement would require 14 burden hours at a cost of $949. Therefore, it would require an estimated306

56,182 burden hours (14 burden hours for each RH C x 4,013 RHCs = 56,182 burden hours) to complete the plan at a cost of $3,808,337 ($949 estimated cost for each RHC x 4,013 RHCs = $3,808,337 estimated cost). We estimate that it would require 8 burden hours for each FQHC to comply with our proposed requirements at a cost of $530. Based on that estimate, it would require 44,272 burden hours (8 burden hours for each FQHC x 5,534 FQHC s = 44,272 burden hours) to complete the plan at a cost of $2,933,020 ($530 estimated cost for each FQHC x 5,534 FQHCs = $2,933,020 estimated cost). Based on the previous estimates, for all RHCs and FQHCs to develop an emergency preparedness plan that complies with our proposed requirements would require 100,454 burden hours at a cost of $6,741,357. Each RHC/FQHC also would be require d to review and update its emergency preparedness plan at least annually. We belie ve that RHCs and FQHCs already review their emergency preparedness plans periodically. Thus, compliance with this requirement would

constitute a usual and customar y business practice for RHCs a nd FQHCs and would not subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 491.12(b) would require RHCs/FQHC s to develop and implement emergency preparedness policies and procedures based on their emergency plans, risk assessments, and communication plans as set forth in § 491.12(a), (a)(1), and (c), re spectively. We would also require RHCs/FQHCs to review and update these pol icies and procedures at least annually. At a minimum, we would require that the RHC/FQ HC’s policies and pro cedures address the requirements listed at § 491.12(b)(1) through (4).307

We expect that all RHCs/FQHCs have some emergency preparedness policies and procedures. All RHCs and FQHCs are required to have emergency procedures related to the safety of their patients in non-medical emergencie s (§ 491.6(c)). They also must set forth in writing their organization’s policie s (§ 491.7(a)(2)). In addition, cu rrent regulations require that a physician, in conjunction with a nurse pract itioner or physician’s assistant, develop the facility’s written policies (§ 491.8( b)(ii) and (c)(i)). However, we expect that all RHCs/FQHCs would need to review their polic ies and procedures, assess whethe r their policies and procedures incorporate their risk assessments and emerge ncy preparedness plans and make any changes necessary to comply with our proposed requirements. We expect that FQHCs already have policie s and procedures that would comply with some of our proposed requirements. Several of the expectations of the Emergency Management PIN address specific elements in proposed § 491.12(b) . For example, the PIN states that FQHCs should address, as appropriate, continuity of operations, staffing, surge patients, medical and non-medical supplies, evacuation, power s upply, water and sanita tion, communications, transportation, and the access to and security of medi cal records (Emergency Management PIN, p. 6). In addition, FQHCs should also continuall y evaluate their EMPs and make changes to their EMPs as necessary (Emergency Management PIN, p. 7). These expectations also indicate that FQHCs should be working with and integra ting their planning with their state and local communities’ plans, as well as other key orga nizations and other relationships (Emergency Management PIN, p. 8). Thus, we expect th at burden for FQHCs from the requirement for emergency preparedness policies and procedures would be less than the burden for RHCs. The burden associated with our proposed requirements would be reviewing, revising, and, if needed, developing new emergency prepar edness policies and procedures. We expect308

that a physician and a nurse practitioner would prim arily be involved with these tasks and that an

administrator would assist them. We estimate that for each RHC to comply with our proposed requirements would require 12 bur den hours at a cost of $968. Based on that estimate, for all 4,013 RHCs to comply with these requirement s would require 48,156 burden hours (12 burden hours for each RHC x 4,013 RHCs = 48,156 burden hours) at a cost of $3,884,584 ($968 estimated cost for each RHC x 4,013 RHCs = $3,884,584 estimated cost). As discussed earlier, we exp ect that FQHCs would have le ss of a burden from developing their emergency preparedness policies and procedur es due to the expectations set out in the Emergency Management PIN. Thus, we estimate that for each FQHC to comply with the proposed requirements would require 8 burden hours at a cost of $608. Ba sed on that estimate, for all 5,534 FQHCs to comply with these requirements would require 44,272 burden hours (8 burden hours for each FQHC x 5,534 F QHCs = 44,272 burden hours) at a cost of $3,364,672 ($608 estimated cost for each FQHC x 5,534 FQHCs = $3,364,672 estimated cost). Based on the previous estimates, for a ll RHCs and FQHCs to develop emergency preparedness policies and procedures that comply with our proposed requirements would require 92,428 burden hours at a cost of $7,249,256. We propose that RHCs/FQHCs review and upda te their emergency preparedness policies and procedures at least annually. We believ e that RHCs and FQHCs already review their emergency preparedness policies and procedures pe riodically. Therefore, compliance with this requirement would constitute a usual and cu stomary business practi ce for RHCs/FQHCs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 491.12(c) would require RHCs /FQHCs to develop and maintain an emergency preparedness communication plan that complied with both federal and state law.309

RHCs/FQHCs would also have to review and upda te these plans at leas t annually. We propose that the communication plan must include the information listed in § 491.12(c)(1) through (5). We expect that all RHCs/FQHCs have some type of emergency preparedness communication plan. It is stan dard practice for health care fa cilities to maintain contact

information for staff and outside sources of assi stance; alternate means of communication in case there is an interruption in the facility’s phone servi ces; and a method for sharing information and

medical documentation with other h ealth care providers to ensure c ontinuity of care for patients. As discussed earlier, RHCs and FQHCs are required to take appropriate measures to ensure the safety of their patients during non-medical emer gencies (§ 491.6(c)). We expect that an emergency preparedness communication plan woul d be an essential element in any emergency preparedness preparations. However, some RHCs/FQHCs may not have a formal, written emergency preparedness communication plan or th eir plan may not include all the requirements

we propose. The Emergency Management PIN contains sp ecific expectations for communications and information sharing (Emergency Management PI N, pp. 8-9). "A well-defined communication plan is an important component of an effective EMP" (Emergency Management PIN, p. 8). In addition, FQHCs are expected to have policie s and procedures for communicating with both internal stakeholders (such as pa tients and staff) and external stakeholders (such as federal, tribal, state, and local agencies), and for identifying who will do the communicating and what type of information will be communicated (Eme rgency Management PIN, p. 8). FQHCs should also identify alternate communications systems in the event that their standard communications systems become unavailable, and the FQHC should identify these alternate systems in their EMP (Emergency Management PIN, p. 9). Thus, we expect that all FQHCs would have a formal310

communication plan for emergencies and that th ose plans would contain some of our proposed requirements. However, we expect that all FQHC s would need to review, revise, and, if needed, develop new sections for their emergency prepar edness communication plans to ensure that their plans are in compliance. We expect that these tasks will require less of a burden for FQHCs than

for the RHCs. The burden associated with complying with this requirement would be the resources required to review, revise, and, if needed, develop new sections for the RHC/FQHC’s emergency preparedness communication plan. Based on our experience with RHCs/FQHCs, as well as the requirements in current regulations for a phys ician to work in c onjunction with a nurse practitioner or a physician assist ant to develop policies, we anticipate that satisfying the requirements in this section would require the in volvement of the RHC/FQHC’s administrator, a physician, and a nurse practitioner or physician assist ant. We expect that the administrator and the nurse practitioner or physicia n assistant would be primarily involved in reviewing, revising, and if needed, developing new sections fo r the RHC/FQHC’s emergency preparedness communication plan. We estimate that for each RHC to comply with the proposed requirements would require 10 burden hours at a cost of $734. Based on that estimate, for all 4,013 RHCs to comply would require 40,130 burden hours (10 burden hours for each RHC x 4,013 RHCs = 40,130 burden hours) at a cost of $3,443,154 ($734 estimated cost for each RHC x 4,013 RHCs = $3,443,154 estimated cost). We estimate that for a FQHC to comply with the proposed requi rements would require 5 burden hours at a cost of $367. Based on this estimate, for all 5,534 FQHCs to comply would require 27,670 burden hours (5 burden hour s for each FQHC x 5,534 FQHCs = 27,670 burden311

hours) at a cost of $2,030,978 ($367 estimated cost for each FQHC x 5,534 FQHCs = $2,030,978 estimated cost). We propose that RHCs/FQHCs also review and update their emergency preparedness communication plans at least a nnually. We believe that RHCs /FQHCs already review their emergency preparedness communication plans pe riodically. Thus, compliance with this requirement would constitute a usual and cu stomary business practi ce for RHCs/FQHCs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 491.12(d) would require RHCs/FQHC s to develop and maintain emergency preparedness training and testing programs a nd review and update th ese programs at least annually. We propose that an RHC/FQHC would have to comply with the requirements listed in § 491.12(d)(1) and (2). Proposed § 491.12(d)(1) would require each RHC and FQHC to provide initial training in emergency preparedness policies and procedures to all new and existi ng staff, individuals providing services under arrangemen t, and volunteers, consistent w ith their expected roles, and maintain documentation of that training. Each RH C and FQHC would also have to ensure that its staff could demonstrate knowledge of those emergency procedures. Thereafter, each RHC and FQHC would be required to provide emergency preparedness training annually. Based on our experience with RHCs and F QHCs, we expect that all 9,045 RHC/FQHCs already have some type of emergency prepare dness training program. The current RHC/FQHC regulations require RHCs and F QHCs to provide traini ng to their staffs on handling emergencies (§ 491.6(c)(1)). In addition, FQHCs are expect ed to provide ongoing training in emergency management and their facilities’ EMP to all of their employees (Emergency Management PIN, p. 7). However, neither the current regulations nor the PIN’s expecta tions for FQHCs address312

initial training and ongoing traini ng, frequency of training, or requirements that individuals providing services under arrangem ent and volunteers be included in the training. RHCs/FQHCs would need to review their current training pr ograms; compare their co ntents to their risk assessments, emergency preparedness plans, po licies and procedures, and communication plans and then take the necessary steps to ensure that their training pr ograms comply with our proposed requirements. We expect that each RHC and FQHC has a professional staff person who is responsible for ensuring that the facility’s tr aining program is up-to-date and complies with all federal, state, and local laws and regulations. Th is individual would lik ely be an administrato r. We expect that the administrator would be primarily involve d in reviewing the RH C/FQHC’s emergency preparedness program; determining what tasks need to be performed and what materials need to be developed to bring the training program into compliance with our proposed requirements; and making changes to current training materials and de veloping new training ma terials. We expect that the administrator would work with a regist ered nurse to develop the revised and updated training program. We estimate that it would require 10 burden hours for each RHC or FQHC to develop a comprehensive emergency training prog ram at a cost of $526. Therefore, it would require an estimated 95,470 burden hours ( 10 burden hours for each RHC/FQHC x 9,547 RHCs/FQHCs = 95,470 burden hours) to comply w ith this requirement at a cost of $5,021,722 ($526 estimated cost for each RHC/FQHC x 9,5 47 RHCs/FQHCs = $5,021,722 estimated cost). Proposed § 491.12(d) would al so require that RHCs/FQH Cs develop and maintain emergency preparedness training and testing programs that woul d be reviewed and updated at least annually. We believe th at RHCs/FQHCs already review their emergency preparedness programs periodically. Therefore, compliance with this requirem ent would constitute a usual313

and customary business practice for RHCs/FQHCs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 491.12(d)(2) would require RHCs/F QHCs to participate in a community mock disaster drill and conduct a paper-based, tabletop exercise at least annually. If a community mock disaster drill was not availa ble, RHCs/FQHCs would have to conduct an individual, facility-bas ed mock disaster drill at least annually. RHCs/FQHCs would also be required to analyze their responses to and mainta in documentation of drills, tabletop exercises, and emergency events, and revise their emergenc y plans, as needed. If an RHC or FQHC experienced an actual natural or man-made emer gency that required activation of its emergency plan, it would be exempt from the requirement for a community or individual, facility-based mock drill for 1 year following the onset of the actual event. However, for purposes of determining the burden for these requirements , we will assume that all RHCs/FQHCs would have to comply with all of these proposed requirements. The burden associated with complying with these requirements would be the resources the RHC or FQHC would need to develop the scenarios for the drill and exercise and the documentation necessary for analyzing and documen ting their drills, tablet op exercises, as well

as any emergency events. Based on our experience with RHCs/FQHC s, we expect that most of the 9,547 RHCs/FQHCs already conduct some type of testi ng of their emergency preparedness plans and develop scenarios and documentation for their testing and emergency events. For example, FQHCs are expected to conduct some type of tes ting of their EMP at least annually (Emergency Management PIN, p. 7). However, we do not belie ve that all RHCs/FQHCs have the appropriate documentation for drills, exercises, and emergency events or that they conduct both a drill and a314

tabletop exercise annually. Thus, we will analyze the burden associated with these requirements for all 9,547 RHCs/FQHCs. Based on our experience with RHCs/FQHCs, we expect that the same individuals who are responsible for developing the RHC/FQHC’s training and testing program would develop the

scenarios for the drills and exercises and the accompanying documentation. We expect that the administrator and a registered nurse would be primarily involved in accomplishing these tasks. We estimate that for each RHC/FQHC to comply with the requirements in this section would require 5 burden hours at a cost of $276. Base d on this estimate, for all 9,547 RHCs/FQHCs to comply with the requirements in this sect ion would require 47,735 bur den hours (5 burden hours for each RHC/FQHC x 9,547 RHCs/FQHCs = 47,735 burden hours) at a cost of $2,634,972 ($276 estimated cost for each RHC/FQHC x 9,547 RHC/FQHCs = $2,634,972 estimated cost).

TABLE 16: BURDEN HOURS A ND COST ESTIMATES FOR ALL 9,547 RHC/FQHCS TO COMPLY WITH THE I CRs CONTAINED IN §491.12 CONDITION: EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/Maintenance Costs ($) Total Cost ($) §491.12(a)(1) (RHCs) 0938- New 4,013 4,013 10 40,130 ** 2,857,256 0 2,857,256 §491.12(a)(1) (FQHCs) 0938- New 5,534 5,534 5 27,670 ** 1,970,104 0 1,970,104 §491.12(a)(1)- (4) (RHCs) 0938- New 4,013 4,013 14 56,182 ** 3,808,337 0 3,808,337 §491(a)(1) – (4) (FQHCs) 0938- New 5,534 5,534 8 44,272 ** 2,933,020 0 2,933,020 §491.12(b) (RHCs) 0938- New 4,013 4,013 12 48,156 ** 3,884,584 0 3,884,584 §491.12(b) (FQHCs) 0938- New 5,534 5,534 8 44,272 ** 3,364,672 0 3,364,672 §491.12(c) (RHCs) 0938- New 4,013 4,013 10 40,130 ** 3,443,154 0 3,443,154 §491.12(c) (FQHCs) 0938- New 5,534 5,534 5 27,670 ** 2030,978 0 2030,978 §491.12(d)(1) 0938- New 9,547 9,547 10 95,470 ** 5,021,722 0 5,021,722 §491.12(d)(2) 0938- New 9,547 9,547 5 47,735 ** 2,634,972 0 2,634,972315

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/Maintenance Costs ($) Total Cost ($) Totals 57,282 471,687 31,948,799 ** The hourly labor cost is blended between the wages for multiple staffing levels.

S. ICRs Regarding Condition of Particip ation: Emergency Preparedness (§ 494.62) Proposed § 494.62(a) would requir e dialysis facilities to de velop and maintain emergency preparedness plans that would have to revi ewed and updated at leas t annually. Proposed § 494.62 would require that the plan include the elements set out at § 494.62(a)(1) through (4). Proposed § 494.62(a)(1) would require dialys is facilities to develop a documented, facility-based and community-based risk assessmen t utilizing an all-hazards approach. The risk

assessment should address the medical and non-me dical emergency events the facility could experience both within the facili ty and within the su rrounding area. The dial ysis facility would have to consider its location and geographical area; patient population, including, but not limited to, persons-at-risk; and the types of services the di alysis facility has the ability to provide in an emergency. The dialysis facility also would need to identify the measures it would need to take to ensure the continuity of its operations, including delegations of authority and succession plans. The burden associated with this requirement would be the resources needed to perform a thorough risk assessment. The current CfCs alrea dy require dialysis fac ilities to "implement processes and procedures to manage medical a nd nonmedical emergencies that are likely to threaten the health or safety of the patients, th e staff, or the public. These emergencies include, but are not limited to, fire, equipment or power failure, care-related emergencies, water supply interruption, and natural disaster s likely to occur in th e facility’s geographi c area" (§ 494.60(d)). Thus, to be in compliance with this CfC, we believe that all dialysis facili ties would have already performed some type of risk assessment duri ng the process of deve loping their emergency316

preparedness processes and procedures. Howe ver, these risk assessments may not be as thorough or address all of the elements requir ed in proposed § 494.62(a). For example, the current CfCs do not require dialysis facilities to plan for man-made disasters. Therefore, we believe that all dialysis facili ties would have to conduct a thor ough review of their current risk assessments and then perform the necessary tasks to ensure that their faci lities’ risk assessments complied with the requireme nts of this section. Based on our experience with dialysis fac ilities, we expect th at conducting the risk assessment would require the involvement of the dialysis facility’s chief executive officer or administrator, medical director, nur se manager, social worker, and a PCT. We believe that all of

these individuals would attend an initial meeting, review releva nt sections of the current assessment, develop comments and recommendati ons for changes to the assessment, attend a follow-up meeting, perform a final re view and approve the risk assessment. We believe that the administrator would probably coordinate the mee tings, do an initial review of the current risk assessment, provide a critique of the risk as sessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and assure that the necessary parties approve the

new risk assessment. We also believe that th e administrator would probably spend more time reviewing and working on the risk assessment than the other individuals involved in performing the risk assessment. Thus, we estimate that co mplying with this requirement to conduct and develop a risk assessment would require 12 burde n hours at a cost of $838. There are currently 5,923 dialysis facilities. Th erefore, it would require an estimated 71,076 burden hours (12 burden hours for each dialysis facility x 5,923 dialysis faci lities = 71,076 burden hours) for all dialysis facilities to comply with this re quirement at a cost of $4,963,474 ($838 estimated cost for each dialysis facility x 5,923 dialysis facilities = $4,963,474 estimated cost).317

After conducting the risk assessment, each dial ysis facility would then have to develop and maintain an emergency preparedness plan that the facility must evaluate and update at least annually. This emergency plan would have to comply with the requirements at proposed § 494.62(a)(1) through (4). Current CfCs already require dialysis fac ilities to "have a plan to obtain emergency medical system assistance when needed. . ." and "evaluate at least annually the effectiveness of emergency and disaster plans and update them as necessary" (§ 494.60(d)(4)). Thus, we expect that all dialysis facilities have some type of emergency preparedne ss or disaster plan. In addition, dialysis facilities must also "implement pr ocesses and procedures to manage medical and nonmedical emergencies that are like ly to threaten the health or safety of the patients, the staff, or the public. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and na tural disasters likely to occur in the facility’s geographic area" (§ 494.60(d)). We expect that the facility would incorporate many, if not all, of these proce sses and procedures into its em ergency preparedness plan. We expect that each dialysis facili ty has some type of emergency pr eparedness plan and that plan should already address many of these requirements. However, all of the dial ysis facilities would have to review their current plans and compar e them to the risk assessment they performed pursuant to proposed § 494.62(a)(1). The dialysis facility would then need to update, revise, and, in some cases, develop new sections to complete an emergency preparedness plan that addressed the risks identified in their risk assessment and the specific requirements contained in this subsection. The plan would also address how the dialysis facility would continue providing its essential services, which are the services that th e dialysis facility woul d continue to provide despite an emergency. The dialysis facility w ould also need to review , revise, and, in some318

cases, develop delegations of authority or successi on plans that the dialysis facility determined were necessary for the appropria te initiation and management of their emergency preparedness plan. The burden associated with this requirement would be the time and effort necessary to develop the emergency preparedness plan. Based upon our experience with di alysis facilities, we expect that developing the emer gency preparedness plan would require the involvement of the dialysis facility’s chief executive officer or admini strator, medical director, nurse manager, social worker, and a PCT. We believe that all of th ese individuals would proba bly have to attend an initial meeting, review relevant sections of th e facility’s current emergency preparedness or disaster plan(s), develop comme nts and recommendations for changes to the assessment, attend a follow-up meeting, and then perform a final review and approve the risk assessment. We believe that the administrator would proba bly coordinate the meetings, do an initial review of the current risk assessment, provide a criti que of the risk assessment, offe r suggested revisions, coordinate comments, develop the new risk assessment, and assure that the necessary parties approved the

new risk assessment. We also believe that the administrator, medi cal director, and nurse manager would probably spend more time review ing and working on the risk assessment than the other individuals involved in developing the plan. The social worker and PCT would likely just review the plan or releva nt sections of it. In additi on, since the medical director’s responsibilities include participa tion in the development of patient care policies and procedures (42 CFR 494.150(c)), we expect that the medical di rector would be involved in the development of the emergency preparedness plan. We estimat e that complying with this requirement would require 10 burden hours at a cost of $776 for each dialysis facility. There are 5,923 dialysis facilities. Therefore, it would require an estimated 59,230 burden hours (10 burden hours for319

each dialysis facility x 5,923 di alysis facilities = 59,230 burden hours) to complete the plan at a cost of $4,596,248 ($776 estimated cost for each dial ysis facility x 5,923 dial ysis facilities = $4,596,248 estimated cost). Each dialysis facility would also be required to review and update its emergency preparedness plan at least annua lly. We believe that dialysis facilities already review their emergency preparedness plans periodically. The cu rrent CfCs already requires dialysis facilities to evaluate the effectiveness of their emergency and disaster plans and update them as necessary (42 CFR 494.60(d)(4)(ii)). Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 494.62(b) would require dialysis facilities to develop and implement emergency preparedness policies and procedur es based on the emergency plan, the risk assessment, and communication plan as set fort h in § 494.62(a), (a)(1), and (c), respectively. These emergencies would include, but would not be limited to, fire, equipment or power failures, care-related emergencies, water supply interrupt ions, and natural and man-made disasters that are likely to occur in the facility’s geographica l area. Dialysis facilities would also have to review and update these policies an d procedures at least annuall y. The policies and procedures would be required to address, at a minimum, the requirements listed at § 494.62(b)(1) through (9). We expect that all dialysis facilities have some emergency preparedness policies and procedures. The current CfCs at 42 CFR 494.60(d) al ready require dialysis facilities to have and "implement processes and procedures to manage medical and nonmedical em ergencies . . . [that] include, but not limited to, fire, equipment or pow er failures, care-related emergencies, water320

supply interruption, and natural disa sters likely to occur in the fac ility’s geographic area". In addition, we expect that di alysis facilities already have procedures that would satisfy some of the requirements in this section. For example, each dialysis facility is al ready required at 42 CFR 494.60(d)(4)(iii) to "contact its local disaster management agency at least annually to ensure that such agency is aware of dialysis facility needs in the event of an emergency". However, all dialysis facilities would need to review their policies and procedures, assess whether their policies and procedures incorporated all of the necessary elements of their emergency preparedness program, and then, if necessary, take the appropriate steps to ensure that their policies and procedures encompassed these requirements. The burden associated with the development of these emergency policies and procedures would be the time and effort necessary to comp ly with these requirements. We expect the administrator, medical director, and the nurse manager would be primarily involved with reviewing, revising, and if need ed, developing any new policies and procedures that were needed. The remaining individuals would likel y review the sections of the policies and procedures that directly affect their areas of expertise. Theref ore, we estimate that complying with this requirement would require 10 burden ho urs at a cost of $776 for each dialysis facility. There are 5,923 dialysis facilities. Therefore, it would require an estimated 59,230 burden hours (10 burden hours for each dialysis facility x 5,923 dialysis faci lities = 59,230 burden hours) to complete the plan at a cost of $4,596,248 ($768 estim ated cost for each dialysis facility x 5,923 dialysis facilities = $4, 5 96,248 estimated cost). The dialysis facility must also review and update its emer gency preparedness policies and procedures at least annually. We believe that di alysis facilities already review their emergency preparedness policies and procedures periodicall y. In addition, the curren t CfCs already require321

(at 42 CFR 494.150(c)(1)) the medical director to part icipate in a periodic review of patient care policies and procedures. Thus, compliance with this requirement would constitute a usual and customary business practice for dialysis facilit ies and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 494.62(c) would require dialysis facilities to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. The dialysis facility must also revi ew and update this plan at leas t annually. The communication plan

must include the information lis ted at § 494.62(c)(1) through (7). We expect that all dialysis facilities have some type of emergency preparedness communication plan. A communication plan woul d be an integral part of any emergency preparedness plan. Current CfCs already require di alysis facilities to have a written disaster plan (42 CFR 494.60(d)(4)). Thus, each dialysis facility should alrea dy have some of the contact information they would need to have in order to comply with this section. In addition, we expect that it is standard practice in the healthcare industry to have and maintain contact information for both staff and outside sources of assistance; alte rnate means of communications in case there is an interruption in phone service to the facility, such as cell phones or text-messaging devices; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for their patients. However, many dialysis facilities may not have formal, written emergency preparedness communication plans. Therefore, we expect that all dialysis facilit ies would need to review, update, and in some cases, develop new sections for their plans to ensure that those plans in cluded all of the previ ously-described required elements in their emergency preparedness communication plan.322

The burden associated with complying with this requirement would be the resources required to review and revise the dialysis facility’s emergency preparedness communication plan to ensure that it complied with these requireme nts. Based upon our experience with dialysis facilities, we anticipate that satisfying these requirements would primarily require the involvement of the dialysis facility’s administra tor, medical director, and nurse manager. For each dialysis facility, we estimate that comply ing with this requirement would require 4 burden hours at a cost of $357. Therefore, for all of the dialysis fac ilities to comply with this requirement would require an estimated 23,692 bur den hours (4 burden hours for each dialysis facility x 5,923 dialysis faci lities = 23,692 burden hours) at a cost of $2,114,511 ($357 estimated cost for each dialysis facility x 5,923 dialysis facilities = $2,114,511 estimated cost). Each dialysis facility would also have to review and update its emergency preparedness communication plan at least annually. For th e purpose of determining the burden for this requirement, we would expect that dialysis faci lities would review their emergency preparedness communication plans annually. We be lieve that all dialysis facilities have an administrator that would be primarily responsible fo r the day-to-day operati on of the dialysis facility. This would include ensuring that all of the dialysis facility’s policies, procedures, and plans were up-to-date and complied with the relevant fe deral, state, and local laws, re gulations, and ordinances. We expect that the administrator would be respons ible for periodically reviewing the dialysis facility’s plans, policies, and procedures as part of his or her work respon sibilities. Therefore, we expect that complying with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 494.62(d) would requir e dialysis facilities to de velop and maintain emergency preparedness training, testing and patient orientation programs that would have to be evaluated323

and updated at least annually. The dialysis facili ty would have to comply with the requirements located at § 494.62(d )(1) through (3). Proposed § 494.62(d)(1) would require that dial ysis facilities provide initial training in emergency preparedness policies and procedures to all new and existi ng staff, individuals providing services under arrangemen t, and volunteers, consistent w ith their expected roles, and maintain documentation of the training. Thereafter, the dialysis facility would have to provide emergency preparedness tr aining at least annually. Current CfCs already require dialysis facili ties to "provide traini ng and orientation in emergency preparedness to the staff" (42 CFR 494.60(d)(1)) and "provide appropriate orientation and training to patients . . ." in emergency preparedness (42 CFR 494.60(d )(2)). In addition, the dialysis facility’s patient instru ction would have to include the sa me matters that are specified in the current CfCs (42 CFR 494.60(d)(2)). Thus, di alysis facilities s hould already have an emergency preparedness training program for ne w employees, as well as ongoing training for all their staff and patients. However, all dialysis facilities would need to review their current training programs and compare their conten ts to their updated emergency preparedness programs, that is, the risk assessment, emerge ncy preparedness plan, policies and procedures, and communications plans that they developed pursuant to proposed § 494.62(a) through (c). Dialysis facilities would then need to review, revise, and in some cases, develop new material for their training programs so that they complied with these requirements. The burden associated with complying with th is requirement would be the time and effort necessary to develop the required training progra m. We expect that complying with this requirement would require the involvement of the administrator, medical director, and the nurse manager. In fact, the medical director’s re sponsibilities include, among other things, staff324

education and training (42 CFR 494.150(b)). We es timate that it would require 7 burden hours for each dialysis facility to develop an emergenc y training program at a cost of $559. Therefore, it would require an estimated 41,46 1 burden hours (7 burden hours fo r each dialysis facility x 5,923 dialysis facilities = 41,461 burde n hours) to comply with this requirement at a cost of ($559 estimated cost for each dialysis facili ty x 5,923 dialysis f acilities = $3,310,957 estimated cost). The dialysis facility must also review and update its emergency preparedness training program at least annually. We believe that dialysis facilities already review their emergency preparedness training programs periodically. Ther efore, compliance with this requirement would

constitute a usual and customar y business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 494.62(d)(2) requires dial ysis facilities to participat e in a mock disaster drill and conduct a paper-based, tabletop exercise at least annually. If a community mock disaster drill was not available, the dialysis facility w ould have to conduct an in dividual, facility-based

mock disaster drill at least annua lly. If the dialysis facility ex perienced an actua l natural or manmade emergency that required activation of their emergency plan, the dialysis facility would be exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual even t. Dialysis facilities would al so be required to analyze their responses to and maintain document of all drills , tabletop exercises, and emergency events. To comply with this requirement, a dialysis facility would need to devel op scenarios for each drill and exercise. A dialysis facility would also have to develop the documentation necessary for recording and analyzing the drills, tabletop exercises, and emergency events.325

The current CfCs already require dialysis facilities to evaluate their emergency preparedness plan at least annually (42 CFR 494.60(d )(4)(ii)). Thus, we exp ect that all dialysis facilities are already conducting so me type of tests to evaluate their emergency plans. Although the current CfCs do not specify th e type of drill or test, dialysis facilities should have already been developing scenarios for testing their plans. Thus, complying with this requirement would

constitute a usual and customar y business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Proposed § 494.62(d)(3) would require dialys is facilities to provide appropriate orientation and training to patie nts, including the areas specifi ed in proposed § 494.62(d)(1). Proposed § 494.62(d)(1) specifically would requi re that staff demonstrate knowledge of emergency procedures including the emergency info rmation they must give to their patients. Thus, the burden associated with this section would already be included in the burden estimate for § 494.62(d)(1).

TABLE 17: BURDEN HOURS A ND COST ESTIMATES FOR ALL 5,923 DIALYSIS FACILITIES TO COMPLY WITH THE ICRs CO NTAINED IN § 494.62 CONDITION: EMERGENCY PREPAREDNESS

Regulation Section(s) OMB Control

No. Respondents Responses Burden per Response

(hours) Total Annual Burden (hours) Hourly Labor Cost of Reporting ($) Total Labor Cost of Reporting ($) Total Capital/ Maintenance

Costs ($) Total Cost ($) §494.62(a)(1) 0938- New 5,923 5,923 12 71,076 ** 4,963,474 0 4,834,422 §494.62(a)(2)- (4) 0938- New 5,923 5,923 10 59,230 ** 4,596,248 0 4,476,744 §494.62(b) 0938- New 5,923 5,923 10 59,230 ** 4,596,248 0 4,476,744 §494.62(c) 0938- New 5,923 5,923 4 23,692 ** 2,114,511 0 2,059,533 §494.62(d) 0938- New 5,923 5,923 7 41,461 ** 3,310,957 0 3,224,871 Totals 5,923 29,615 254,689 19,581,438 ** The hourly labor cost is blended between the wages for multiple staffing levels.326

T. Summary of Information Collection Burden Based on the previous analysis, the first y ear’s burden for complying with all of the requirements in this proposed rule w ould be 3,018,124 burden hours at a cost of $185,908,673. For subsequent years, if there is any addi tional burden, it would be negligible. To obtain copies of the supporting statemen t and any related forms for the proposed paperwork collections referenced ea rlier, access CMS’ Web site at http://www.cms.gov/PaperworkReduc tionActof1995/PRAL/list.asp#TopOfPage or email your request, including your address, phone number, OM B number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Re ports Clearance Office at 410-786–1326. If you comment on these information collecti on and recordkeeping requirements, please mail copies directly to the following:

Centers for Medicare & Medicaid Services, Office of Strategic Operati ons and Regulatory Affairs, Regulations Development Group, Attn.: William Parham, (CMS-3178-P), Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850; and Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: CMS Desk Officer, CMS-3178-P , Fax (202) 395-6974.327

IV. Regulatory Impact Analysis

A. Statement of Need Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributiv e impacts, and equity). In response to past terrorist at tacks, natural disasters, and th e subsequent national need to refine the nation’s strategy to ha ndle emergency situations, there continues to be a coordinated effort across federal agencies to establish a foundation for developm ent and expansion of emergency preparedness systems. There are two Presidential Directives, HSPD-5 and HSPD-21, instructing agencies to coordinate their emerge ncy preparedness activities with each other. Although these directives do not specifically requ ire Medicare providers and suppliers to adopt measures, they have set the stage for what we e xpect from our providers and suppliers in regard to their roles in a more unified emergency preparedness system. Homeland Security Presidential Directive (HSPD-5): Management of Domestic Incidents authorizes the Depart ment of Homeland to develo p and administer the National Incident Management System (NIMS). Homeland Security Presidential Directive (HSPD-21) addresses public health and medical preparedness. The directive establis hes a National Strategy for Public Health and Medical Preparedness (Strategy), which builds u pon principles set forth in “Biodefense for the

21 st Century (April 2004), “National Strategy fo r Homeland Security” (October 2007), and the “National Strategy to Combat Weapons of Ma ss Destruction” (December 2002). The directive328

aims to transform our national approach to prot ecting the health of the American people against

all disasters. B. Overall Impact We have examined the impacts of this proposed rule as required by Executive Order 12866 on Regulatory Pla nning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Re gulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), sect ion 1102(b) of the Social Security Act,

section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995 Pub. L. 104-4), and Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S. C. 804(2)). Executive Orders 12866 and 13563 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (i ncluding potential economic , environmental, public health and safety effects, distributive imp acts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically sign ificant effects ($100 million or more annually). The total projected cost of this rule would be $225 million in the first year, and the subsequent projected annual cost would be approximately $ 41 million. Published reports after Hurricane Katrina re ported that the Louisiana Attorney General investigated approximately 215 deaths that o ccurred in hospitals and nursing homes following Katrina. Since nearly all hospitals and nursing ho mes are certified to par ticipate in the Medicare program, we estimate that at least a small percentage of these lives could be saved as a result of emergency preparedness measures in a single disast er of equal magnitude. Katrina is an extreme example of a natural disaster, so we also cons idered other more common disasters. The United329

States experiences numerous natural disasters an nually, including, in part icular, tornadoes and flooding. Based on data from the National Oceanic and Atmospheric Administration, the United States experiences an annual average of 56 fatalities as a re sult of tornadoes ( http://www.spc.noaa.gov/wcm/us tormaps/1981-2010-stateavgfatals.png ). On average, floods kill about 140 people each year (United States Department of the Interior, United States Geological Survey Fact Sheet "Flood H azards—A National Threat" January, 2006, at Http://pubs.usgs.gov/fs/2006/3026/2006-3026.pdf ). Floods may be caused by both natural and manmade processes, including hurricanes, severe storms, snowmelt, and dam or levee failure. According to the National Weather Service, in 2010 there were a cumulative 490 deaths and 2,369 injuries and in 2011 there were a cumulative 1,096 deaths and 8,830 injuries as a result of severe weather events such as tornadoes, floods , winter storms, and others. Although we are unable to specifically quan tify the number of lives saved as a re sult of this proposed rule, all of the data we have read regarding emergenc y preparedness indicate that implementing the requirements in this proposed rule could have a significant impact on pr otecting the health and safety of individuals served by providers and s uppliers that participate in the Medicare and Medicaid programs. We believe it is crucial for all providers and suppliers to have an emergency disaster plan that is integrated wi th other local, state and federal agencies to effectively address both natural and manmade disasters. Therefore, we believe that it is essential to require providers and supplie rs to conduct a risk assessment, to develop an emergency preparedness plan based on the assessment, a nd to comply with the other requirements we propose to minimize the disruption of services fo r the community and ensu re continuity of care

in the event of a disaster.330

We believe that this proposed rule would be an economically signi ficant regulatory action under section 3(f)(1) of Executiv e Order 12866, since it may lead to impacts of greater than $100 million in the first year follo wing the rule’s effective date. This proposed rule would establish a regul atory framework with which Medicare- and Medicaid-participating providers and suppliers woul d have to comply to ensure that the varied providers and suppliers of hea lthcare are adequately prepar ed to respond to natural and

man-made disasters.

Several factors influenced our estimates of the economic impact to the providers and suppliers covered by this proposed rule. These f actors are discussed under section III. of this proposed rule (Collection of Information Require ments). In addition, we have used the same

data source for the RIA that we used to deve lop the PRA burden estima tes, that is, the CMS Online Survey, Certification, and Reporting System (OSCAR). The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) (RFA) requires agencies that issue a regulation to analyze options for regulator y relief of small businesses if a rule has a significant impact on a substantial number of sma ll entities. The Act generally defines a “small entity” as: (1) a proprietary firm meeting the si ze standards of the Small Business Administration (SBA); (2) a not-for-profit orga nization that is not dominant in its field; or (3) a small government jurisdiction with a popul ation of less than 50,000. St ates and individuals are not included in the definition of “small entity.”) HHS uses as its measure of significant economic impact on a substantial number of small entitie s a change in revenues of more than 3 to 5 percent. The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entit ies. For purposes of the RFA,331

we estimate that most hospitals and most other pr oviders and suppliers are small entities, either by nonprofit status or by having revenues of less than $35.5 million in any 1 year. For purposes of the RFA, a majority of hospitals are consider ed small entities due to their non-profit status.

Individuals and states are not included in the definition of a small entity. Since the cost associated with this proposed rule is less th an $46,000 for hospitals and $4,000 for other entities, the Secretary has determined that this proposed will not have a significant economic impact on a

substantial number of small entities.” In addition, section 1102(b) of th e Social Security Act require s us to prepare a regulatory impact analysis if a rule may have a significant impact on the ope rations of a substantial number of small rural hospitals. This analysis must conf orm to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we defi ne a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. Since the cost associated with this proposed rule is less th an $46,000 for hospitals, this this proposed will not have a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Re form Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits be fore issuing any rule that includes a federal mandate that could result in expenditure in any 1 year by state, local or tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2013, that threshold level is a pproximately $141 million. This omnibus proposed rule contains mandates that would impose a one-time cost of approximately $225 million. Thus,

we have assessed the various costs and benefits of th is proposed rule. It is clear that a number of providers and suppliers would be affected by the implementation of this proposed rule and that a

substantial number of those entiti es would be required to make ch anges in their operations. This332

proposed rule would not mandate any new requirements for state, local or tribal governments. For the private sector facilities , this regulatory impact section c onstitutes the analysis required

under UMRA. Executive Order 13132 establishes certain requirem ents that an agency must meet when it develops a proposed rule (and subsequent final ru le) that imposes substant ial direct requirement costs on state and local governments, preempt s state law, or otherwise has Federalism implications. This proposed rule will not impose substantial direct requirement costs on state or local governments, preempt state law, or otherwise implicate federalism. This proposed regulation is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.) and has

been transmitted to the Congress and the Comptroller General for review. C. Anticipated Effects on Providers and Suppliers: General Provisions This proposed rule would require each of the Medicare- and Me dicaid-participating providers and suppliers discussed in previous sections to perform a risk analysis; establish an emergency preparedness plan, emergency prep aredness policies and procedures, and an emergency preparedness communication plan; train staff in emergency preparedness, and test the emergency plan. The economic impact would di ffer between hospitals and the various other providers and suppliers, dependi ng upon a variety of factors, including existi ng regulatory requirements and accreditation standards. We discuss the economic impact for each provi der and supplier type included in this proposed rule in the order in whic h they appear in the CFR. Most of the economic impact of this proposed rule would be due to the cost for providers and suppliers to comply with the information collection requirements. Thus, we discuss most of the economic impact under the333

Collection of Information Requireme nts section of this proposed rule . We provide a chart at the end of the RIA section of the total regul atory impact for each provider/supplier.

As stated in the ICR sect ion, we obtained all salary information from the May 2011 National Occupational Employment and Wage Estim ates, United States by the Bureau of Labor Statistics (BLS) at http://www.bls.gov/oe s/current/oes_nat.htm and calculated the added value of benefits using the estimation th at salary accounts for 70 percent of compensation, based on BLS information (Bureau of Labor Statistics News Release, "Employer Cost Index—December 2011,

retrieved from www.bls.gov/news.release/pdf/eci.pdf ) . 1. Subsistence Requirement This proposed rule would require all inpatient providers to meet the subsistence needs of staff and patients, whether they evacuate or sh elter in place, including, but not limited to, food, water, and supplies, alternate sources of energy to maintain temperatures to protect patient health and safety and for the safe and san itary storage of such provisions. Based on our experience, we expect inpatient providers to currently have food, water, and supplies, alternate sources of energy to provi de electrical power, and the maintenance of temperatures for the safe and sanitary storage of such provisions as a routine measure to ensure against weather related and non-disaster power fail ures. Thus, we believe that this requirement is a usual and customary business practice for in patient providers and we have not assigned any impact for this requirement. Further, we expect that most providers have agreements w ith their vendors to receive supplies within 24 to 48 hours in the event of an emergency, as well as arrangements with backup vendors in the event that the disaster affect s the primary vendor. We considered proposing a requirement that providers must keep a larger qua ntity of food and water on hand in the event of334

a disaster. However, we believe that a provider should have the fl exibility to determine what is adequate based on the location a nd individual characte ristics of the facility. While some providers may have the storage capacity to stockpile supplies that would last for a longer duration, other may not. Thus, we believe that to require such stockpi ling would create an unnecessary economic impact on some health care providers. We expect that when inpatient providers determine their supply needs, they would consider the possibility that vol unteers, visitors, and individual s from the community may arrive at the facility to offer assistance or seek shelter. Based on the previous factors, we have not estimated a cost for a stockpile of food and

water. 2. Generator Location and Testing This proposed rule would require hospitals , CAHs, and LTC facilities to test and maintain their emergency and standby power system s in such a way to ensure proper operation in the event they are needed. The 2000 edition of the Life Safety Code (LSC) of the National Fire Protection Association (NFPA) states that the alternate source of power (for example, generator) must be located in an appropriate area to mi nimize the possible damage resulting from disasters such as storms, floods, earthquakes, tornadoes, hurricanes, vandalism, sabotage and other material and equipment failures. Since hospitals , CAHs and LTC facilities are currently required to comply with the referenced LSC, we ha ve not assigned any addi tional burden for this requirement. In addition to the emergency power system inspection and testing requirements found in NFPA 99 and NFPA 110 and NFPA 101, we propose that hospitals test their emergency and stand-by-power systems for a minimum of 4 con tinuous hours every 12 months at 100 percent of335

the power load the hospital anticipates it will requ ire during an emergency. As a result of lessons learned from hurricane Sandy, we believe that this annual 4 hour test will more closely reflect

the actual conditions that would be experienced during a disaster of the magnitude of hurricane Sandy. Also, later editions of NFPA 110 require 4 hours of continuous ge nerator testing every 36 months to provide reasonable assurance em ergency power systems are capable of running under load during an emergency. In order to prov ide further assurance th at generators will be capable of operating during an emergency, 4 hours of continuous gene rator testing will be required every 12 months. We have also pr oposed the same emergency and standby power requirements for CAHs and LTC facilities.

We have estimated the cost in this sec tion for these additional testing requirements.

Based on information from the U.S. Bureau of La bor Statistics and the U.S. Energy Information Administration, we have calcula ted the cost for the genera tor testing as follows:

• Labor: 6 hours (1-hour preparation, 4 hour run-time, 1 hour restoration) x $25.45 an

hour =$152.70

• Fuel: Diesel cost of $3.85 per gallon x 72 gallon per hour x 4 hour of testing=$1,108.80 Therefore, we estimate the total cost to each hospital, CAH and LTC facility to comply with this requirement would be $1,262. However, we request information on this proposal and in particular on how we might better estimate cost s in light of the exis ting LSC and other state and federal requirements. D. Condition of Participation: Emergency Prep aredness for Religious Nonmedical Health Care Institutions (RNHCIs) 1. Training and Testing (§ 403.748(d))336

We discuss the majority of the economic impact for this requirement in the ICR section, which is estimated at $18,928. 2. Testing (§ 403.748(d)(2)) Proposed § 403.748(d)(2) would require RHNC Is to conduct a paper-based, tabletop exercise at least annually. RHNCIs must anal yze their response and maintain documentation of all tabletop exercises, and emergency events, and revise their emergency plan as needed. We expect that the cost associated with th is requirement would be limited to the staff time needed to participate in th e tabletop exercises. We estimat e that approximately 4 hours of staff time would be required of the administra tor and director of nur sing, and 2 hours of staff

time for the head of maintenance to coordinate facility evacuati ons and protocols for transporting

residents to alternate si tes. We believe that other staff members would be required to spend a minimal amount of time during these exercises and such staff time w ould be considered a part of regular on-going training for RH NCI staff. We estimate that it would require 10 hours of staff

time for each of the 16 RNHCIs to conduct exerci ses at a cost of $330. Therefore, it would require an estimated total impact of $5,280 each y ear after the initial y ear for all RNHCIs to comply with proposed § 403.748(d)(2). For the initial year, we estimate $24,208 as the total economic impact and cost estimates for all 16 RNHC Is to comply with the requirements in this proposed rule. E. Condition for Coverage: Emergency Preparedness for Ambulatory Surgical Centers (ASCs)- -Testing (§ 416.54(d)(2)) Proposed § 416.54(d)(2) would require ASCs to participate in a community mock disaster drill at least annually. If a community mock disaster drill were not available, the ASC would be required to conduct a fac ility-based mock disaster drill at least annually and maintain337

documentation of all mock disaster drills. AS Cs also would be required to conduct a paperbased, tabletop exercise at least annually. ASCs also would be required to maintain

documentation of the exercise. State, Tribal, Territorial, and local public health and medical systems comprise a critical infrastructure that is integr al to providing the early recogni tion and response necessary for minimizing the effects of catastrophic public heal th and medical emergencies. Educating and training these clinical, laboratory, and public health professionals has been, and continues to be, a top priority for the federal Government. There are currently three programs at HHS addressing education and training in the ar ea of public health emergency pr eparedness and response: the Centers for Public Health Preparedness (CPHP) , the Bioterrorism Training and Curriculum Development Program (BTCDP), and Nati onal Laboratory Training Network (NLTN). As discussed earlier in this preamble, ASCs can use these and other resources, such as tools offered by the Department of Homeland Securi ty, to assist them in complying with this proposed requirement. Thus, we be lieve that the cost associated with this requirement would be limited to the staff time to participate in the community-wide and facility-wide trainings, and tabletop exercises. We believe th at appreciable staff tim e would be required of the administrator

and risk assurance nurse. We believe that ot her staff members would be required to spend a minimal amount of time during thes e exercises and the training woul d be considered as part of regular on-going training for ASC staff. We estimate that the administrator and quality assurance nurse would spend about 4 hours each on an annual basis to partic ipate in the disaster drills (3 hours to participate in a community or facility-wide dril l and 1 hour to participate in a table-top drill). Thus, we anticipate that comp lying with this requirement would require 8 hours for an estimated cost of $500 for each of th e 5,354 ASCs and a total cost estimate of $2,677,000338

for all ASCs ($500 x 5,354 ASCs) each year after the first year. We estimate $15,241,036 ($2,677,000 impact cost+ $12,564,036 ICR burden) as the total economic impact and cost estimates for all ASCs to comply with the requirements in this proposed rule. F. Condition of Participation: Emergency Pr eparedness for Hospices--Testing (§ 418.113(d)(2)) Proposed § 418.113(d)(2)(i) through(iii) would require hospices to participate in mock drills and tabletop exercises at least annually. In a ddition, hospices are to conduct a paper-based, tabletop exercise at leas t annually. We believe that the admi nistrator would be responsible for participating in community-wide disaster drills and would be the primary person to organize a facility-wide drill and tabletop exercise with th e assistance of one member of the IDG. We believe that the registered nurse would most likel y represent the IDG on the drills and exercises. While we expect that all staff w ould be involved in the drills a nd exercises, we would consider their involvement as part of their regular staff tr aining. However, for the purpose of this analysis we assume that the administrator would spend ap proximately 3 hours annually to participate in a community or facility-wide drill and 1 hour to participate in a tabletop exercise above their regular and ongoing training. We also assume that the registered nurse would spend 3 hours to participate in an annual drill and 1 hour to participate in a tablet op exercise. Thus, we estimate that each hospice would spend $388. The total estimate for all hos pices to comply with this requirement after the initial year would total $1,463,924 ($388 x 3,773 hospices). We estimate the total economic impact and cost estimates for all 3,773 hospices to comply with the requirements in this proposed rule for the initial year would be $11,908,072 ($1,463,924 impact cost + $10,444,148 ICR burden).339

G. Emergency Preparedness for Psychiatric Resi dential Treatment Facilities (PRTFs)--Training and Testing (§ 441.184(d)) Proposed § 441.184(d)(2)(i) through (iii) woul d require PRTFs to participate in a community or facility-based mock disaster drill and a tabletop exercise annually. We propose that if a community drill is not available, the PRTF would be re quired to conduct a facility-based

mock disaster drill. We estimate that the cost as sociated with this requirement is the time that it would take key personnel to part icipate in the mock drill and tabletop exercise. We further

estimate that the drill and exercise would involve the administrator and registered nurse to spend about 4 hours each on an annual basis to participat e (3 hours to particip ate in a community or facility-wide drill and 1 hour to participate in a table-top drill). Thus, we anticipate that complying with this requirement would require 4 hours for the administrator and 4 hours for the registered nurse at a combined estimated cost of $360 per facility. The to tal annual cost for all 387 PRTFs would be $139,320. The total cost for the first year to comply with the requirement would be $1,071,990 ($139,320 impact cost + $932,670 ICR burden). H. Emergency Preparedness for Program for th e All-Inclusive Care for the Elderly (PACE) Organizations--Training and Testing (§ 460.84(d)) Proposed § 460.84(d)(2)(i) through (iii) would require PACE organizations to conduct a mock community or facility-wide drill and a pa per-based, tabletop exercise annually. Since PACE organizations are currently required to conduct a facility-wide drill annually, we are only estimating economic impact for the annual tabletop drill. We expect that both the home-care coordinator and the quality-improvement nurse would each spend 1 hour to conduct the tabletop exercise. Thus, we estimate the economi c impact hours to be 2 hours for each PACE organization (total impact hours=182) at an es timated cost of $90 for each organization. The340

total annual cost for all PACE organizations is $8,190 ($90 x 91 providers). The total cost for all PACE organizations to comply with the re quirements in the first year would be $342, 888 ($8,190 impact cost + $334,698 ICR burden). I. Condition of Participation: Emergency Preparedness for Hospitals 1. Medical Supplies (§ 482.15(b)(1)) We propose that hospitals must maintain medical supplies. The American Hospital Association (AHA) recommends that individual hospitals have a 24-hour supply of pharmaceuticals and that they de velop a list of required medical and surgical equipment and supplies. TJC standards require a hospital to have a 48 to 72 hour stockpile of medication and supplies. The Department of Homeland Security ( DHS) Act of 2002 established the Strategic National Stockpile (SNS) Program to work with governmental and non-governmental partners to upgrade the nation’s public health capacity to respond to a nati onal emergency. The SNS is a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications and medical supplies. The SNS, and other federal agencies, http://emergency.cdc .gov/stockpile/index.asp , have plans to address the medical need s of an affected population in th e event of a disaster. The SNS has large quantities of medicine and medical supplies to protect th e American public if there is a public health emergency (for example, a terrori st attack, flu outbreak, or earthquake) severe enough to cause local supplie s to run out. After federal and lo cal authorities agree that the SNS is needed, medicines can be delivered to any stat e in the U.S. within 12 hours. Each state has plans to receive and distribute SNS medicine and medical supplies to local communities as341

quickly as possible. States have the discretion to decide where to dist ribute the supplies in the event of multiple events.However, prudent emergency planning requires that some supplies be maintained inhospital for immediate needs. The Federal Me tropolitan Medical Response System (MMRS) guidelines call for MMRS communities to be se lf-sufficient for 48 hours. We encourage hospitals to work with stakeholders (state boards of pharmacy, pharmacy organizations, and public health organizations) for guidance and as sistance in identifying medications they may need. Based on our experience with hospitals, we believe that they would have on hand a 2 to 3 day supply of medical supplies at the onset of a disaster. Afte r such time, supplies could be replenished from the SNS and other federal ag encies. Therefore, based on the previous information, we are not assessing additional burden for medical supplies. 2. Training Program (§ 482.15(d)(1)) Proposed § 482.15(d)(1) would require hospitals to develop and maintain an emergency preparedness training program and review and update it at least annually. Based on our experience with health car e facilities, we expect that all health care faci lities provide some type of training to all personnel, including those prov iding services under contract or arrangement and volunteers. Since such training is required for the TJC-accredited hospitals, the proposed requirements for developing an emergency prepare dness-training program and the materials they plan to use in providing initial and on-going annual training would c onstitute a usual and customary business practice for TJC-accredited hospitals. However, under this proposed rule, non TJC-acc redited hospitals woul d need to review their existing training program a nd appropriately revise, update, or develop new sections and new material for their training program. The ec onomic impact associated with this requirement342

is the staff time required for non-TJC accredited ho spitals to review, update or develop a training program. We discuss the economic impact fo r this requirement in the ICR section. 3. Testing (§ 482.15(d)(2)(i) through (iii)) Proposed § 482.15(d)(2)(i) through (iii) would require hospitals to participate in or conduct a mock disaster drill and a paper-bas ed, tabletop exercise at least annually. State, tribal, territorial, and local public hea lth and medical systems comprise a critical

infrastructure that is inte gral in providing early recogni tion and response necessary for minimizing the effects of catastrophic public heal th and medical emergencies. Educating and training these clinical, laboratory, and public health professionals has been, and continues to be, a top priority for the federal government. Ther e are currently four pr ograms at HHS addressing education and training in the ar ea of public health emergency pr eparedness and response. The programs are the Centers for Public Health Prep aredness (CPHP), The Biot errorism Training and Curriculum Development Program (BTCDP), and National Laboratory Training Network (NLTN). As discussed earlier in this preamble, hospitals can us e these and other resources, such as tools offered by the DHS, to assist them in complying with this proposed requirement. Thus, for non-TJC accredited hospitals, the costs associated with this requirement would be primarily due to the staff time needed to participate in the community-wide and f acility-based disaster drills, and the tablet op exercises. We believe that apprecia ble staff time would be required of the risk management director, faciliti es director, safety director, and security manager. We expect that other staff members would be required to spend a minimal amount of time during these exercises, which would be considered a part of regular on-going training fo r hospital staff. We estimate that the risk management director, faci lities director, safety director and security343

manager would spend about 12 hours each (8 hours for a disaster drill and 4 hours for a tabletop exercise) on an annual basis to meet the proposed requirement. Thus, we have estimated the economic impact for the 1,518 non-TJC accredited hospitals. We anticipate that complying with this requirement would require 48 hours for an estimate of $3,360 for each non TJC-accredited hosp ital. Therefore, for all non TJC-accredited hospitals to comply with this requirement would require 72,864 tota l economic impact hours (48 economic impact hours per non TJC-accr edited hospital x 1,518 non TJC-accredited hospitals = 72,864 total economic impact hours) at an estimated to tal cost of $5,100,480 ($3,360 per non TJC-accredited hospita l x 1,518 hospitals = $5,100,480). Based on TJC’s standards, the TJC-accredited ho spitals are currently required to test their emergency operations plan twice a year. Ther efore, for TJC-accredite d hospitals to conduct disaster drills and tabletop ex ercises would constitute a usua l and customary business practice and we will not include this activity in the economic impact analysis. 4. Generator Testing (§482.15(e)) Section § 482.15(e) would require hospitals to test each emergency generator and any associated essential electric systems for a mi nimum of 4 continuous hours at least once every

12 months under a full electrical load anticipated to be required dur ing an emergency. The intent of this requirement is to provide an increased assurance that a ge nerator and associated essential electrical systems will function during an em ergency and are capable of running under a full electrical load required during an emergency for an extended period of time. AO’s, including TJC, DNV, and HFAP; currently re quire accredited hospitals to te st their generators/emergency power supply system once for 4 continuous hours ev ery 36 months. Therefor e, the cost of the existing testing requirement was deducted from the cost calculation for accredited hospitals.344

However, under this proposed rule, non-accredite d hospitals would be required to run their emergency generators an additional 4 hours, with an additional 1 hour for preparation, and an

additional 1 hour for restoration. For non-accredited hospitals, we estimate labor cost to be $132,696 (6 hours x $25.45/hr ($152.70) x 869 non-accredited hospitals ). We estimate fuel cost to be $963,547 (72 gallon/hr x $3.85/gallon x 4 hours ($1,108.80) x 869 non-accredited hospitals) for non-acc redited hospitals. Thus for non-accredited hospitals, we estimate the to tal cost to comply with this requirement to be $1,096,243. For accredited hospitals, we estimate labor cost to be $413,206 (2 (6 hours x $25.45/hr)/3 ($101.80)) x 4,059 accredited hospitals). We estimate fuel cost to be $3,000,413 (2 (72 gallon/hr x $3.85/gallon x 4 hours) /3 ($739.2)) x 4,059 accredit ed hospitals) for accr edited hospitals. Thus for accredited hospitals, we estimate the total cost to comply with this requirement to be $3,413,619. Therefore, the total economic impact of this rule on hospitals would be $39,265,594 ($5,100,480 disaster drills impact cost + $4,509,862 generator impact cost + $29,655,252 ICR burden). J. Condition of Participation: Emerge ncy Preparedness for Transplant Centers There is no additional economic impact to discu ss in this section for transplant centers. All transplant centers are located within a hos pital and, thus, would not have to stockpile supplies in an emergency or conduct a mock disaster drill or a tabletop exercise.345

K. Emergency Preparedness L ong Term Care (LTC) Facilities 1. Subsistence (§ 483.73(b)(1)) Section § 483.73(b)(1) would require LTC faciliti es to provide subsistence needs for staff and residents, whether they evacuate or shel ter in place, including, but not limited to, food, water, and medical supplies alternate sources of energy for the provision of electrical power, and maintenance of temperatures for the safe and sanitary storage of such provisions.

As stated earlier in this secti on, each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible. The federal responsibility ceases at the delivery of the push-packs to state-designated airports. It is then the responsibil ity of the state to break down and transport the components of the push-pack to the affected community. It is also at the state’s discretion where to deliver push-pack ma terial in the event of multiple events. We expect that a 1- to 2-da y supply would be sufficient beca use various national agencies with stockpiles of medicine, medical supplies, food and water can be mobilized within 12 hours and supplies can be replenished or provided within 48 hours. Thus, for the sake of this impact analysis, we assume that, at a minimum, a LTC facility would have a 2-day supply of food and potable water for the patients and staff at the onset of a disaster and will no t assign a cost to this requirement. We encourage LTC facilities to work with stakeholders (State Boards of Pharmacy, pharmacy organizations, and public health or ganizations) for guidance and assistance in identifying medications that may be needed and plan to provide access to all healthcare partners during an event.346

2. Training and Testing (§ 483.73(d)) Section § 483.73(d)(2)(i) through (iii) would requi re LTC facilities to participate in or

conduct a mock disaster drill and a tabletop exercise at least annua lly. The current requirements for LTC facilities already mandate that these facili ties periodically review their procedures with existing staff, and carry out unannounced staff drills (42 CFR 483.75(m)(2)). Thus, we expect that complying with the requirement for an a nnual community or facility-wide mock disaster drill and tabletop would constitu te a minimal economic impact, if any, after the first year. 3. Generator Testing (§ 483.73(e)) Proposed § 483.73(e) would require LTC facilities to test each emergency generator for a

minimum of 4 continuous hours at least once ever y 12 months. We estimate labor cost to be $2,314,474 (6 hours x $25.45/hr ($152.70) x 15,157 LTC facilities). We estimate fuel cost to be $16,806,082 (72 gallon/hr x $3.85/gallon x 4 hours ( $1,108.80) x 15,157 facilities ). Therefore, we anticipate that complying with this requirement would cost an estimated $19,120,556. L. Condition of Participation: Emergency Preparedness for Intermediate Care Facilities for

Individuals with Intellectu al Disabilities (ICFs/IID) 1. Testing (§ 483.475(d)(2)) Proposed § 483.475(d)(2)(i) through (iii) would require ICFs/IID to participate in or conduct a mock disaster drill and a paper-based, ta bletop exercise at leas t annually. The current ICF/IID CoPs require them to conduct evacuation drills at least quarterly for each shift and under

varied conditions to evaluate th e effectiveness of emergency and disaster plans and procedures" (42 CFR 483.470(i) and (i)(iii)). In addition, ICFs/IID must evacu ate clients during at least one drill each year on each shift, file a report and evaluation on each evacuation drill and investigate all problems with evacuation drills, includi ng accidents, and ta ke corrective action347

(42 CFR 483.470(i)(2)). Thus, all 6,450 ICFs/IID al ready conduct quarterly drills. We estimate that any additional economic impact for an ICF/II D to conduct both a drill and an exercise would be minimal, if any. Therefore, the cost of this proposed rule for all ICFs /IID would be limited to the ICR burden of $15,538,104 as disc ussed in the COI section. M. §484.22 Condition of Participation: Emerge ncy Preparedness for Home Health Agencies (HHAs) --Training and Testing (§ 484.22(d)) We discuss the majority of the economic imp act for this requirement in the COI section which is estimated to be $48,725,629. Proposed § 484.22(d)(2)(i) through (iii) w ould require HHAs to participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, we would require the HHA to conduct an individual, facility-based mock disaster drill at least annually and maintain documentation of a ll mock disaster drills. We would also require

the HHA to maintain documentation of the exercises. There are currently two programs at HHS addre ssing education and training in the area of public health emergency preparedness and response: the Centers for Public Health Preparedness (CPHP), and National Laborator y Training Network (NLTN). As discussed earlier in this preamble, HHAs can use these and other resources, such as tools offered by the Department of Homeland Securi ty, to assist them in complying with this requirement. Thus, we believe that the cost asso ciated with this requirement would be limited to the staff time to participate in the community -wide and facility-wide trainings, and tabletop

exercises. We believe that a ppreciable staff time would be re quired of the administrator and director of training. We believe that other staff members would be required to spend a minimal amount of time during these exercises and the traini ng would be considered as part of regular on-348

going training for HHA staff. We estimate that the administrator would spend about 1 hour on the community-wide disaster drill and 1 hour on the tabletop drill (a total of 2 hours to participate in drills). We also estimate that th e director of training woul d spend a total of 3 hours on an annual basis to participate in the disaster drills (2 hours to participate in a community or facility-wide drill and 1 hour to participate in a tabletop drill) . All TJC accredited HHAs are required annually to test their emergency management program by conducting drills and documenting their results. Thus, we anticipat e that only non-TJC accredited HHAs would need to comply with this requirement. We anticipate that it would require 5 hours for each of the 10,615 non-JC-accredited HHAs, with an estimate d cost of $2,897,895. Therefore, the total economic impact of this rule on HHAs would be $51,623,524 ($2,897,895 impact cost + $48,725,629 ICR burden). N. Conditions of Participation: Comprehensiv e Outpatient Rehabilita tion Facilities (CORFs)-- Testing (§ 485.68(d)(2 )(i) through (iii)) Proposed § 485.68(d)(2)(i) through ( iii) would require CORFs to participate in or conduct a mock disaster drill and a paper-based, tablet op exercise at least annually and document the drills and exercises. To comply with this requi rement, a CORF would need to develop a specific

scenario for each drill and exercise. The current CoPs require CORFs to provide ongoing drills for all personnel associated with the facility in al l aspects of disaster preparedness (42 CFR 485.64(b)(1)). Thus, for the purpose of this analysis, we be lieve that CORFs would incur mi nimal or no additional cost to comply with this requirement. Thus, we estimate the cost for all 272 CORFs to comply with this requirement would be limited to the ICR burden of $828,784 discussed in the COI section.349

O. Condition of Participation: Emergency Pr eparedness for Critical Access Hospitals (CAHs) 1. Testing (§ 485.625(d)(2)) Proposed § 485.625(d)(2)(i) through (iii) would require CAHs to conduct annual community or facility-based drills and tablet op exercises. Accredited CAHs are currently required to conduct such drills and exercises. Although we believe that non-accredited CAHs are currently particip ating in such drills and exercises, we are not convinced that it is at the level that would be required under this proposed rule . Thus, we will analyze the economic impact for these requirements for the 920 non-accredited CAHs. As discussed earlier in this preamble, CAHs would have access to various training reso urces and emergency preparedness initiatives to use in complying with this requirement. Thus, we believe that the cost associated with this requirement would be limited to staff time to participate in the community-wide and facility-wide trainings, and tablet op exercises. We believe that appreciable staff time would be required of the administrator, facilities dire ctor, director of nursi ng and nursing education

coordinator. We believe that other staff members would be re quired to spend a minimal amount of time during these exercises that would be cons idered as part of re gular on-going training for hospital staff. We estimate that the administrato r, facilities director, and the director of nursing would spend approximately a total of 20 hours on an annual basis to partic ipate in the disaster drills. Thus, we anticipate that complying with this requirement would require 20 hours for an estimated cost of $1,132 for each of the 920 non-accredited CAHs. Therefore, for all nonaccredited CAHs to comply with this requireme nt, it would require 18,400 total economic impact hours (20 economic impact hours per non-accred ited CAH x 920 non-accredited CAH) at an estimated total cost of $1,041,440 ($1,132 x 920).350

2. Generator Testing (§485.625(e)) Proposed §485.625(e) would require CAHs to test each emergency generator for a

minimum of 4 continuous hours at least once ev ery 12 months. AO’s, including TJC, DNV, and HFAP; currently require accredite d CAHs to test their genera tors/emergency power supply system once for 4 continuous hours every 36 months. Therefore, the cost of the existing testing requirement was deducted from the cost calcul ation for accredited CAHs. However, under this proposed rule, non-accredited CAHs would be required to run th eir emergency generators an additional 4 hours, with an a dditional 1 hour for preparation, and an additional 1 hour for

restoration. For non-accredited CAHs, we estimate la bor cost to be $139,721 (6 hours x $25.45/hr ($152.70) x 915 non-accredited CAHs). We estimat e fuel cost to be $1,014,552 (72 gallon/hr x $3.85/gallon x 4 hours ($1,108.80) x 915 non-accredited CAHs) for non-accredited CAHs. Thus for non-accredited CAHs, we estimate the total cost to comply with this requirement to be $1,154,273. For accredited CAHs, we estimate labor co st to be $41,433 (2 (6 hours x $25.45/hr) / 3 ($101.80)) x 407 accredited CAHs). We estimate fuel cost to be $300,854 (2 (72 gallon/hr x $3.85/gallon x 4 hours) /3 ($739.2)) x 407 accredite d CAHs) for accredited CAHs. Thus for accredited CAHs, we estimate the total cost to comply with this requirement to be $342,287. Therefore, the total economic impact of this rule on CAHs would be $8,339,742 ($1,041,440 disaster drills impact cost +$1,496,560 generator impact cost + $5,801,742 ICR burden).351

P. Condition of Participation: Emergency Prepar edness for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Ou tpatient Physical Therapy and Speech-Language Pathology ("Organizations")-- Testing (§ 485.727(d)(2 )(i) through (iii)) Current CoPs require these organizations to ensure that employees are trained in all aspects of preparedness for any disaster. They are also required to have ongoing drills and exercises to test their disaster plan. Rehabilita tion Agencies would need to review their current activities and make minor adjustme nt to ensure that they comp ly with the new requirement. Therefore, we expect that the economic impact to comply with this requirement would be minimal, if any. Therefore, the total economic im pact of this rule on these organizations would be limited to the estimated ICR burden of $6,939,456. Q. Condition of Participation: Emergency Prep aredness for Community Mental Health Centers (CMHCs)--Training and Testing (§ 485.920(d)) Proposed § 485.920(d)(2) would require CMHCs to participate in or conduct a mock disaster drill and a paper-based, ta bletop exercise at least annually. We estimate that to comply with the requirement to participate in a commu nity mock disaster drill or to conduct an individual facility-based mock drill and a tabletop exercise annua lly would primarily require the involvement of the administrator and a register ed nurse. We estimate that the administrator would spend approximately 4 hours to participat e in a community or facility-wide drill and 1 hour to participate in a tabletop drill. We al so estimate that a nurse would spend about 3 hours on an annual basis to participate in the disaster drills (2 hours to participate in a community or facility-wide drill and 1 hour to participate in a tabletop drill). Thus, we anticipate that complying with this requirement would require 8 hours for each CMHC at an estimated cost of $415 for each facility. The economic impact fo r all 207 CMHCs would be 1656 (8 impact hours352

x 207 CMHCs) total economic impact hours at a total estimated cost of $85,905 ($415 x 207 CMHCs). Therefore, the total economic impact of this rule on CMHCs would be $674,820 ($85,905 impact cost + $588,915 ICR burden). R. Conditions of Participation: Emergency Pr eparedness for Organ Procurement Organizations (OPOs)--Training and Testing (§ 486.360(d)(2)(i) through (iii)) The OPO CfCs do not currently contain a requ irement for OPOs to conduct mock disaster drills or paper-based, tabletop exercises. We es timate that these tasks would require the quality assessment and performance improvement (QAPI) dire ctor and the education coordinator to each spend 1 hour to participate in the tabletop exer cise. Thus, the total annual economic impact

hours for each OPO would be 2 hours. The tota l cost would be $107 for a (QAPI coordinator hourly salary and the Education Coordinator to participate in the ta bletop exercise. The economic impact for all OPOs would be 116 (2 impact hours x 58 OPOs) total economic impact hours at an estimated cost of $6,206 ($107 x 58 OPOs). Therefore, the total economic impact of this rule on OPOs would be $613,176 ($6,206 impact cost + $606,970 ICR burden). S. Emergency Preparedness: Conditions for Cert ification for Rural Health Clinics (RHCs) and Conditions for Coverage for Federally Qualified Health Clinics (FQHCs) 1. Training and Testing (§ 491.12 (d)) We expect RHCs and FQHCs to participate in their local and state emergency plans and training drills to identify local and regional disaster cen ters that could prov ide shelter during an

emergency. We propose that an RHC/FQHC must revi ew and update its emergency preparedness policies and procedures at least annually. For purposes of determining the economic impact for this requirement, we expect that RHCs/FQHC s would review their emergency preparedness353

policies and procedures annually. Based on our experience with Medi care providers and suppliers, health care facilities generally have a compliance officer or other staff member who reviews the facility’s pr ogram periodically to ensure that it complies with all relevant federal, state, and local laws, regulations, and ordina nces. We believe that complying with the requirement for an annual review of the emerge ncy preparedness policies and procedures would constitute a minimal economic impact, if any. 2. Testing (§ 491.12(d)(2)(i) through (iii)) Proposed § 491.12(d)(2)(i) thr ough (iii) would require RHCs/F QHCs to participate in a community or facility-wide mock disaster drill and a tabletop exercise at least annually. We have stated previously that F QHCs are currently required to conduct annual drills. We believe that for FQHCs to comply with these requireme nts would constitute a mi nimal economic impact, if any. Thus, we are estimating the economic impact for RHCs to comply with these requirements to conduct mock drills and tablet op exercises. We estimate that a RHCs administrator would spend 4 hours annually to participate in the disaster drills . Also, we estimate that a nurse coordinator (registered nurse) would each spend 4 hours on an annual basis to participate in the disaster dri lls (3 hours to participate in a co mmunity or facility-wide drill and 1 hour to participate in a tabl e-top drill). Thus, we anticip ate that complying with this requirement would require 8 hours for each RHC for an estimated cost of $452 per facility. The total annual cost for 4,013 RHCs would be $1,813,876. Therefore, the total economic impact of this rule on RHCs/FQHCs would be $33,762,675 ($1,813,876 impact cost + $31,948,799 ICR burden).354

T. Condition of Participation: Emergency Prep aredness for End-Stage Renal Disease Facilities (Dialysis Facilities )--Testing (§ 494.62(d )(2)(i) through (iv)) Proposed § 494.62(d)(2) would require dialysis f acilities to participate in or conduct a mock disaster drill and a pape r-based, tabletop exercise at l east annually. The current CfCs already require dialysis facilities to evaluate their emergency prep aredness plan at least annually (§ 494.60(d)(4)(ii)). Thus, we expect that all di alysis facilities are alre ady conducting some type

of tests to evaluate their emer gency plans. Although the current CfCs do not specify the type of drill or test, we believe that dialysis facilities are currently participating in community or facility-wide drills. Therefore, for the purpose of this impact anal ysis, we estimate that dialysis facilities would need to add the tabletop exercise to their emergency preparedness activities. We estimate that it would require 1 hour each for th e administrator (hourly wage of $74.00) and the nurse manager (hourly wage of $64.00) to conduct the annual tabletop exercise. Thus, for the 5,923 dialysis facilities to comply with th e proposed requirements for conducting tabletop exercises, we estimate 11,846 economic impact hours. We estimate the total cost to be $138 for each facility, with a total economic impact of $817,374 ($138 x 5,923 facilities). Therefore, the total economic impact of this rule on ESRD facilities would be $20,398,812 ($817,374 impact cost + $19,581,438 ICR burden). U. Summary of the Total Costs The following is a summary of the total providers and the annual cost estimates for all providers to comply with the requirements in this rule.355

TABLE 18--TOTAL ANNUAL COST TO PARTICIPATE IN DISASTER DRILLS AND TEST GENERATORS ACROSS THE PROVIDERS

Facility Number of Participants Total Cost (in $) RNHCI 16 5,280 ASC 5,354 2,677,000 Hospices 3,773 1,463,924 PRTFs 387 139,320 PACE 91 8,190 Hospital 4,928 9,769,771 LTC 15,157 19,128,134 HHAs 12,349 2,897,895 CAHs 1,322 2,541,639 CMHCs 207 85,905 OPOs 58 6,206 RHCs & FQHCs 9,547 1,813,876 ESRD 5,923 817,374 Total 83,802 41,354,514

Based upon the ICR and RIA analyses, it would require all 83,802 providers and suppliers covered by this emergency preparedness proposed rule to comply with all of its requirements an estimated tota l first-year cost of $225,268,957.

TABLE 19--TOTAL ESTIMATED COST FR OM ICR AND RIA TO COMPLY WITH THE REQUIREMENTS CONTAINED IN THIS PROPOSED RULE

Facility Number of Participants Total Cost in Year 1 (in $) Total Cost in Year 2 and thereafter (in $) RNHCI 16 24,208 5,280 ASC 5,354 15,241,036 2,677,000 Hospices 3,773 10,076,910 1,463,924 PRTFs 387 1,071,990 139,320 PACE 91 342,888 8,190 Hospital 4,928 39,265,594 9,769,771 Transplant Center 770 1,399,104 0 LTC 15,157 19,128,134 19,128,134 ICF/IID 6,442 15,538,104 0 HHAs 12,349 51,623,524 2,897,895 CORFs 272 828,784 0 CAHs 1,322 8,339,742 2,541,639 Organizations 2,256 6,939,456 0 CMHCs 207 674,820 85,905356

Facility Number of Participants Total Cost in Year 1 (in $) Total Cost in Year 2 and thereafter (in $) OPOs 58 613,176 6,206 RHCs & FQHCs 9,547 33,762,675 1,813,876 ESRD Facilities 5,923 20,398,812 817,374 Total 68,852 225,268,957 $41,354,514

The previous summaries include only the upfront and routine costs associated with emergency risk assessment, development and updating of polic ies and procedures, development and maintenance of communication plans, disaster tr aining and testing, and generator te sting (as specified). If these preparations are effective, they will lead to increased amounts of life-saving and morbidity-reducing activities during emergency events. These activities impose cost on society; for example, if complying with this proposed rule’s requirements allows an ESRD facility to remain open during and immediately after a natural disast er, there would be associated in creases in provision of dialysis services, thus entailing labor, material and other costs. As discussed in the next sectio n (“Benefits of the Proposed Rule”), it is difficult to predict how di saster responses would be different in the presence of this proposed rule than in its absence, so we have been unable to quantify the portion of costs that will be incurred during emergencies. We reque st comments and data regarding this issue. Moreover, we have not estimated any costs fo r generator backup, on the assumption that such backup is already required for virt ually all inpatient and many outpati ent facilities, either for TJC or other accreditation, or under state or local codes. We request info rmation on this assumption and in particular on any situations or pr ovider types for which this could tu rn out to be unne cessarily costly. V. Benefits of the Proposed Rule The U.S. Department of Health and Hu man Services, in its Program Guidance for emergency preparedness grants, stated, "as frontline entities in re sponse to mass casualty incidents, hospitals and other he althcare providers such as hea lth centers, rural hospitals and private physicians will be looked to for minimizing the loss of life and permanent disabilities.357

Hospitals and other healthcare provi der organizations must be able to work not only inside their own walls, but also as a team during an emergenc y to respond efficientl y. Hospitals currently, either through experience or em pirical evidence, gain knowledge that causes them to become very adept at flexing their systems to respond in an emergency. Because we live under the threat of mass casualties occurring at anytime and anywhe re with consequences that may be different than the day-to-day occurrences , the healthcare system must be prepared to respond to these events by working as a team or community system." This proposed rule is intended to help en sure the safety of individuals by requiring providers and suppliers to adequately plan for and respond to both natural and man-made

disasters. The devastation of the Gulf Coast by Hurricane Katrina is on e of the most horrific

disasters in our nation’s history. In those chaotic early days following the disaster in the greater New Orleans area, hundreds of thousands of pe ople were adversely impacted, and health care services were not available for many who needed them. The recent disaster caused by hurricane Sandy has shown that additional safeguards should be in place to secure lifesaving equipment, such as generators. There is no reason to think that future disasters mi ght not be as large or larger, as illustrated by the tsunami that hit Japan in 2011.

In the event of such disast ers, vulnerable populations are at greatest risk for negative consequences from healthcare disruptions. A ccording to one study, children and adolescents

with chronic conditions are at increased risk of adverse outcomes follo wing a natural disaster (Rath, Barbara, et. al. “Adverse Health Outcom es after Hurricane Katrina among Children and

Adolescents with Chronic Conditi ons” Journal of Health Care for the Poor and Underserved 18:2, May 2007 pp. 405-417). Another study reports that more than 200,000 people with chronic medical conditions were displaced by Hurricane Katrina (Kopp, Jeffrey, et .al. “Kidney Patient358

Care in Disasters: Lessons from the Hurri canes and Earthquake of 2005” Clin J Am Soc Nephrol 2:814-824, 2007.) Individu als requiring mental health treatments are another at-risk population that can be adversely impacted by health care disruptions following an emergency or disaster. A 2008 study concluded that many Hurri cane Katrina survivors with mental disorders experienced unmet treatment needs, including frequent disruptions of existing care and widespread failure to initiate treatment for new- onset disorders (Wang, P.S., et.al. “Disruption of Existing Mental Health Treatments and Fail ure to Initiate New Treatment After Hurricane

Katrina. American Journal of Psychiatry, 165(1), 34-41)” (2006). Hospital closures during Sandy resulted in up to a 25 percent increase in emergency department visits at numerous centers in Ne w York and a 70-percent increase in ambulance traffic. A proportion of this increase was due to populations being unable to receive routine care. Not only do vulnerable populations experience disruptions in care, they may also incur increased costs for care, especially when those who requi re ongoing medical treatmen t during disasters are required to visit emergency departments for treatment and/or hospitalization. Emergency department visits incur a copay fo r most beneficiaries. Similar co sts are also incurred by patients for hospitalizations. The litera ture shows that natural catastr ophes disproportionately affect ill and socioeconomically disadvantag ed populations that are most at risk (Abdel-Kader K, Unrah ML. Disaster and end-stage renal disease: targ eting vulnerable patients for improved outcomes. Kidney Int. 2009;75:1131-1133; Zorast er R, Vanholder R, Sever MS. Disaster management of chronic dialysis patients. Am J Disaster Med. 2007;2(2):96-106; and Re dlener I, Reilly M. Lessons from Sandy—Preparing Health Systems for Future Disasters. N ENGL J MED. 367;24:2269-2271).359

We know that advance planni ng improves disaster response . In 2007, Modern Healthcare reported on a healthcare system’s re sponse to encroaching wildfires in California. Staff from a San Diego hospital and adjacent nursing facility tr ansported 202 patients and ensured all patients were out of harm’s way. The facilities were ready because of protocols and evacuation drills instituted after a prior event th at allowed them to be prepared (Vesely, R. (2007). Wildfires worry hospitals. Modern Healthcare, 37(43), 16). Therefore, we believe that it is essential to require provi ders and suppliers to conduct a risk assessment, to develop an emergency prep aredness plan based on the assessment, and to comply with the other requirements we propose to minimize the disruption of services for the community and ensure continuity of care in the event of a disast er. As noted previously, we have varied our requirements by provider type and understand that the degree of vulnerability of patients in a disaster will vary according to provider type. For example, patients with scheduled outpatient appointments such as someone coming in for speech therapy or routine clinic services is likely more self-reliant in a disaster than someone in a hospital ICU or someone who is homebound and receiving services from an HHA. Overall, we believe that rule would reduce th e risk of mortality a nd morbidity associated

with disasters. We believe it ve ry likely that some kind of disaster will occur in coming decades in which substantial numbers of lives will be saved by current emergency preparedness as supplemented by the additional measures we propose here. In New Orleans it seems very likely

that dozens of lives could have been saved by competent emergency planning and execution. While New Orleans has a unique location below sea level, everywhere in the United States is vulnerable to weather emergencies and other potent ial natural or manmade disasters. We have not prepared an estimate in eith er quantitative or dollar terms of the potential life-saving benefits360

of this proposed rule. There are several reasons for this, most not ably the difficulty of estimating how many additional lives would be saved from emergency preparedness contingency planning and training. While we are unable to estimate the number of lives that could be saved by emergency planning and execution, Table 20 provide s the number of Medicare FFS beneficiaries receiving services from some of the provider ty pes affected by this proposed rule during the month of July 2013. We are unable to provide vo lume data for those patients in Medicare Advantage plans or the Medica id population. However, one could assume the July 2013 summary is representative of an average month dur ing the year. In the ev ent of a disaster, the fee-for-service patients represented in Table 20 coul d be at risk and therefore, we could assume that they could benefit from the additional emergency preparedness measures proposed in this

rule.

TABLE 20—NUMBER OF MEDICARE FFS PATIENTS WHO RECEIVED SERVICES IN JULY 2013 Provider Type Number of FFS Patients Hospitals 6,910,496 Community Mental Health Center 84,959 Comprehensive Outpatient Rehabilitation Facility 4,045 Critical Access Hospital 655,757 HHA 1,033,909 Hospice 312,799 Hospital based chronic renal disease facility 10,239 Non hospital renal disease treatment center 274,638 Religious Nonmedical Health Care Institution 44 Renal disease treatment center 8,261 Rural health clinic (free standing) 261,067 Rural health clinic (provider based) 291,180 Skilled Nursing Facility 538,189 Note: In July 2013 there were 8,949,161 distinct patients. Benefits from effective disa ster planning would not only accr ue to individuals requiring

health care services. Health care facilities th emselves may benefit from improved ability to maintain or resume delivering services. After Hu rricane Katrina, 94 dialysis facilities closed for361

at least one week. Almost 2 years later, in June, 2007, 17 dialysis facilities remained closed (Kopp et al, 2007). Following hurricane Sandy, $180 million of the $810 million damages reported by the New York City Health and Hospital s Corporation was due to lost revenue. Lost revenue from Long Beach Medica l Center hospital and nursi ng home was estimated at $1.85 million a week after closing due to damage from hurricane Sandy (http://www.modernhealthcare.com/ar ticle/20121208/MAGAZIN E/312089991#ixzz2adUDjFIE? trk=tynt). Finally, taxpayers and insurance companie s may benefit from effective emergency preparedness. After Hurricane Ike, it was estimated that the cost to Medicare for ESRD patients presenting to the ED for dialysis instead of thei r usual facility was, on av erage, $6,997 per visit. Those ESRD patients who did not require dialysis were billed $482 on average (McGinley et al, 2012). The usual cost for these patients as reim bursed through Medicare is in the order of $250 to 300 per visit. Many of these costs or lost revenues may be mitigated by effective emergency preparedness planning. For a non-ESRD individual who cannot receive care from his or her office-based physician but must instead go to an emergency room, not only are the individual’s costs increased, but reimbursement through Medicar e, Medicaid or private insurance is also increased. AHRQ’s Medical Expenditure Pane l Survey from 2008 notes that the average expense for an office based visit was $199 versus $922 for an emergency room visit (Machlin, S., and Chowdhury, S. “Expenses and Character istics of Physician Visits in Different Ambulatory Care Settings, 2008.” Statistical Brief #318. March 2011. Agency for Healthcare Research and Quality, Rockville, MD. http://www.meps.ahrq.gov/mepsweb/data_f iles/publications/s t318/stat318.pdf).362

With the annualized costs of the rule’s em ergency preparedness requirements estimated to be approximately $80 million depending on th e discount rate used (see the accounting statement table that follows) and the rule gene rating additional, unquantified costs associated with the life-saving activities that become im plementable as a result of the preparedness requirements, this proposed rule would have to result in at least $80 million in average yearly benefits, principally derived from reductions in morbidity and mortality, for the benefits to equal

or exceed costs. ASPR and CMS conducted an analysis of the impact of Superstorm Sandy on ESRD patients using Medicare claims. Prelimin ary results have identified increases in ESRD treatment disruptions, emergency department vi sits, hospitalizations, and 30-day mortality for ESRD patients living in the areas affected by the storm. This an alysis supports other research and experience that clearly demonstrates a rela tionship between dialysis disruptions and higher rates of adverse events. Adopti on of the requirements in this proposed rule would better enable individual facilities to: anticipate threats; rapidl y activate plans, processes and protocols; quickly communicate with their patients, other facilities and state or local officials to ensure continuity of care for these life maintaining services; and re duce healthcare system stress by remaining open or re-opening quickly following closure. This would decrease the rate of interrupted dialysis, thereby reducing preventable ED visits, hospitalizations, and mortality during and following

disasters. We welcome comments that may help us qua ntify potential morbidity reductions, lives saved, and other benefits of the proposed rule.

W. Alternatives Considered 1. No Regulatory Action As previously discussed, the status quo is not a desirable alternative because the current regulatory requirements for Me dicare and Medicaid provid ers and suppliers addressing363

emergency and disaster preparedness are insuffici ent to protect beneficiaries and other patients during a disaster. 2. Defer to Federal, State, and Local Laws

Another alternative we considered would be to propose a regulation that would require Medicare providers and suppliers to comply with local, state and federal laws regarding emergency/disaster planning. Various federal, state and local entities (FEMA, the National Response Plan (NRP), CDC, the Assistant S ecretary for Preparedne ss and Response (ASPR), et al) have disaster management plans that provide an integrated process that involves all local and regional emergency responders. We also considered allowing health care providers to voluntarily implement a comprehensive emergenc y preparedness program utilizing grant funding from the Office of the Assistant Secretary for Preparedness and Response, (ASPR). Based on a 2010 survey of the American College of Healthca re Executives (ACHE), less than 1 percent of hospital CEOs identified “disaste r preparedness” as a top priority. Also, a 2012 survey of 1,202 community hospital CEOs (found at: http://www.ache.org/P ubs/Releases/2013/Top-IssuesConfronting-Hospitals-2012.cfm) of ASPR’s Hospital Preparedness Program (HPP) showed that disaster preparedness was not iden tified as a top issue. We belie ve that absent conditions of participation/certification/coverage, providers and suppliers would not consistently adhere to the various local, state and federal emergency pr eparedness requirements. Moreover, many such

instructions are unclear as to what is mandatory or only strongly recommended, and written in ways that leave compliance difficult or impossibl e to determine consistently across providers. Such inconsistent application of local, stat e, and federal requirements could compound the problems faced by governments, health care organi zations, and citizens during a disaster. In364

addition, CMS regulations would enable CM S to survey and enforce the emergency preparedness requirements using sta ndard processes and criteria. 3. Back-up power for Outpatient Facilities A potential regulatory alternative would invol ve requiring a power backup of some kind for outpatient facilities such as FQHCs and ESRD clinics. Some state codes, for example, require power backup, not generator backup, in such facilities. There are a number of ramifications of such options including, for exam ple, preservation of re frigerated drugs and biologics, and the potential cost s of replacing such items if pow er is not maintained for the duration of the emergency. For example, the cu rrent backup power would normally be expected to last for hours, not days. 4. Outpatient Tracking Systems Under another regulatory alternative, we woul d require facilities to have systems in place to keep track of outpatients; the benefits of this alterna tive would depend on whether such systems would have any chance of success in any emergency that led to substantial numbers of refugees before, during, or after the event. As an illustrative example, most southern states have hurricane evacuation systems in place. It is not uncommon for a million people or more to evacuate before a major hurricane arrives. In this or other situations, w ould it even be possible, and if so using what methods, for a hospital out patient facility, an ESRD clinic, a Community Mental Health Center, or an FQHC to attempt to track patients? We w ould appreciate comments

that focus on both costs and benefits of such efforts. 5. Request for Comments on Alternative Approaches to Implementation We request information and comments on the following issues:365

• Targeted approaches to emergency prepar edness—covering one or a subset of provider classes to learn from implementation prio r to extending the ru le to all groups.

• A phase in approach— implementing the re quirements over a longer time horizon, or differential time horizons for the respective provider classes. We are proposing to implement all of the requirements 1 year afte r the final rule is published.

• Variations of the primary requirements—f or example, we have proposed requiring two annual training exercises—it would be instru ctive to receive public feedback on whether both should be required annually, se miannually, or if training shoul d be an annual or semiannual requirement.

• Integration with current requiremen ts-- we are soliciting comment on how the proposed requirements will be integrated with/s atisfied by existing policies and procedures which regulated entities ma y have already adopted.

6. Conclusion We currently have regulations for Medicare and Medicaid providers and suppliers to protect the health and safety of Medicare benefi ciaries and others. We re vise these regulations on

an as-needed basis to address chan ges in clinical practice, patient needs, and public health issues. The responses to the various past disasters demons trated that our current regulations are in need of improvement in order to protect patients, resi dents, and clients during an emergency and that emergency preparedness for health care providers and suppliers is an urge nt public health issue. Therefore, we are promulgating emergency preparedness requireme nts that will be

consistent and enforceable for all Medicare and Medicaid providers and suppliers. This proposed rule addresses the three key elements n eeded to ensure that health care is available during emergencies: safeguarding human resources , ensuring business continuity, and protecting366

physical resources. Current regulations for Medi care and Medicaid providers and suppliers do not adequately address these key elements. X. Accounting Statement As required by OMB Circul ar A-4 (available at http://www.whitehouse.gov/omb/circular/a004/a-4.pdf ), we have prepared an accounting statement. As previously explained, achieving the full scope of potential savings will depend on

the number of lives affected or save d as a result of this regulation.

TABLE 21-- ACCOUNTING STATEMENT

Units Category Estimates Year Dollar Discount Rate Period Covered Benefits Qualitative Help ensure the safety of individuals by requiring providers and suppliers to adequately plan for and respond to both natural and man-made disasters. Costs* 86 2013 7% 2014 - 2018 Annualized Monetized ($million/year) 83 2013 3% 2014 - 2018 Qualitative Costs of performing life-saving and morb idity-reducing activities during emergency events. *The cost estimation is adjusted from 2011 to 2013 year dollars us ing the CPI-W published by Bur eau of Labor Statistics in June 2013. In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget.367

List of Subjects

42 CFR Part 403 Grant programs-health, Health insurance, Hospitals, Intergovernmental relations, Medicare, Reporting and recordkeeping requirements

42 CFR Part 416 Health facilities, Health professions , Medicare, Reporting and recordkeeping requirements.

42 CFR Part 418 Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements

42 CFR Part 441 Aged, Family planning, Grant programs-healt h, Infants and children, Medicaid, Penalties, Reporting and recordkeeping requirements.

42 CFR Part 460 Aged, Health care, Health records, Medi caid, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 482 Grant programs-health, Hospitals, Medicai d, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 483 Grant programs-health, Health facilities, Hea lth professions, Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting and recordkeeping requirements, Safety.368

42 CFR Part 484 Health facilities, Health professions , Medicare, Reporting and recordkeeping requirements.

42 CFR Part 485 Grant programs-health, Health facilitie s, Medicaid, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 486 Grant programs-health, Health facilities, Medicare, Reporting and recordkeeping requirements, X-rays

42 CFR Part 491 Grant programs-health, Health facilitie s, Medicaid, Medicare, Reporting and recordkeeping requirements, Rural areas.

42 CFR Part 494 Health facilities, Incorporat ion by reference, Kidney dis eases, Medicare, Reporting and recordkeeping requirements.369

For the reasons set forth in the preamble, th e Centers for Medicare a nd Medicaid Services proposes to amend 42 CFR Chapter IV as set forth below:

PART 403--SPECIAL PROGRAMS AND PROJECTS 1. The authority citation for Part 403 continues to read as follows: Authority : 42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). § 403.742 [Amended] 2. Amend §403.742 by: A. Removing paragraphs (a)(1), (4), and (5). B. Redesignating paragraphs (a)(2) and (3) as paragraphs (a)(1) and (2), respectively. C. Redesignating paragraphs (a)(6) thr ough (8) as paragraphs (a)(3) through (5), respectively. 3. Add § 403.748 to subpart G to read as follows: § 403.748 Condition of participation: Emergency preparedness. The Religious Nonmedical Health Care In stitution (RNHCI) must comply with all applicable Federal and State emergency prepare dness requirements. The RNHCI must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must in clude, but not be limited to, the following

elements: (a) Emergency plan . The RNHCI must develop and maintain an emergency preparedness plan that must be reviewed, and upda ted at least annually. The plan must do all of the following: (1) Be based on and include a documented, facility-based and community-based risk370

assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emerge ncy events identified by the risk assessment. (3) Address patient population, including, but no t limited to, persons at-risk; the type of

services the RNHCI has the abilit y to provide in an emergency; and, continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situa tion, including documentation of the RNHCI’s

efforts to contact such official s and, when applicable, of its pa rticipation in collaborative and cooperative planning efforts. (b) Policies and procedures

. The RNHCI must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: (1) The provision of subsistence needs for staff and patients, whether they evacuate or shelter in place, include, but are not limited to the following: (i) Food, water, and supplies. (ii) Alternate sources of en ergy to maintain the following: (A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (B) Emergency lighting. (C) Fire detection, extingui shing, and alarm systems.371

(D) Sewage and waste disposal. (2) A system to track the location of sta ff and patients in the RN HCI’s care both during and after the emergency. (3) Safe evacuation from the RNHCI, which includes the following (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communicat ion with external sources of assistance. (4) A means to shelter in place for patient s, staff, and volunteers who remain in the facility. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Ensures records are secu re and readily available. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. (7) The development of arrangements with other RNHCIs and other providers to receive patients in the event of limitations or cessati on of operations to ensu re the continuity of nonmedical services to RNHCI patients. (8) The role of the RNHCI under a waiver declared by the Secretary, in accordance with section 1135 of Act, in the provi sion of care at an a lternate care site id entified by emergency management officials.372

(c) Communication plan . The RNHCI must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing se rvices under agreement. (iii) Next of kin, guardian or custodian. (iv) Other RNHCIs. (v) Volunteers. (2) Contact information for the following (i) Federal, State, trib al, regional, and local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means for communicating with the following: (i) RNHCI’s staff. (ii) Federal, State, trib al, regional, and local emergency management agencies. (4) A method for sharing information and care documentation for patients under the RNHCI’s care, as necessary, with care providers to ensure continuity of care, based on the written election statement made by the pati ent or his or her legal representative. (5) A means, in the event of an evacuati on, to release patient information as permitted

under 45 CFR 164.510. (6) A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4).373

(7) A means of providing information about the RNHCI’s occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. (d) Training and testing . The RNHCI must develop and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually. (1) Training program. The RNHCI must do all of the following: (i) Initial training in emer gency preparedness policies and procedures to all new and existing staff, individuals provi ding services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency prepare dness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Ensure that staff can demonstrat e knowledge of emergency procedures. (2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A ta bletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed.

PART 416--AMBULATORY SURGICAL SERVICES 4. The authority citation for Part 41 6 continues to read as follows: Authority : Secs. 1102 and 1871 of the Social Secu rity Act (42 U.S.C. 1302 and 1395hh).374

§ 416.41 [Amended] 5. Amend § 416.41 by removing paragraph (c). 6. Add § 416.54 to subpart C to read as follows: § 416.54 Condition for coverage: Emergency preparedness. The Ambulatory Surgical Center (ASC) must comply with all applicable Federal and State emergency preparedness requirements. The ASC must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan. The ASC must develop and main tain an emergency preparedness plan that must be reviewed, and updated at l east annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emerge ncy events identified by the risk assessment. (3) Address patient population, including, butnot limited to, the t ype of services the ASC has the ability to provide in an emerge ncy; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the ASC’s efforts to contact such officials and, when applicable , of its participation in collaborative and cooperative planning efforts. (b) Policies and procedures. The ASC must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of375

this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: (1) A system to track the location of sta ff and patients in the AS C’s care both during and after the emergency. (2) Safe evacuation from the ASC, which includes the following: (i) Consideration of care and treatment needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communicat ion with external sources of assistance. (3) A means to shelter in place for patients, staff, and volunteers who remain in the ASC. (4) A system of medical docum entation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Ensures records are secu re and readily available. (5) The use of volunteers in an emergency and other staffing stra tegies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. (6) The development of arrangements with other ASCs and other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to ASC patients. (7) The role of the ASC under a waiver de clared by the Secretar y, in accordance with376

section 1135 of the Act, in the provision of care a nd treatment at an alternat e care site identified by emergency management officials. (c) Communication plan. The ASC must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing serv ices under arrangement. (iii) Patients’ physicians. (iv) Other ASCs. (v) Volunteers. (2) Contact information for the following: (i) Federal, State, trib al, regional, and local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means for communicating with the following: (i) ASC’s staff. (ii) Federal, State, trib al, regional, and local emergency management agencies. (4) A method for sharing information and medical documentation for patients under the ASC’s care, as necessary, with other health care providers to ensure continuity of care. (5) A means, in the event of an evacuati on, to release patient information as permitted

under 45 CFR 164.510. (6) A means of providing information about the general condition and location of377

patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). (7) A means of providing information about the ASC’s needs, and its ability to provide assistance, to the authority having jurisdicti on the Incident Command Center, or designee. (d) Training and testing . The ASC must develop and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually. (1) Training program . The ASC must do all of the following: (i) Initial training in emer gency preparedness policies and procedures to all new and existing staff, individuals providing on-site services unde r arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency prepare dness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Ensure that staff can demonstrat e knowledge of emergency procedures. (2) Testing . The ASC must conduct exercises to test the emergency plan. The ASC must do the following: (i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the ASC experiences an actual na tural or man-made emergency that requires activation of the emergency plan, the ASC is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year followi ng the onset of the actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge378

an emergency plan. (iv) Analyze the ASC’s response to and ma intain documentation of all drills, tabletop exercises, and emergency events and revi se the ASC’s emergency plan, as needed.

PART 418-- HOSPICE CARE 7. The authority citation for Part 41 8 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Secu rity Act (42 U.S.C. 1302 and 1395hh),

unless otherwise noted. § 418.110 [Amended] 8. Amend § 418.110 by removing paragraph (c)(1)(ii) and by removing the paragraph designation (i) from paragraph (c)(1)(i). 9. Add § 418.113 to subpart D to read as follows: § 418.113 Condition of participation: Emergency preparedness. The hospice must comply with all applicable Federal and State emergency preparedness requirements. The hospice must establish and ma intain an emergency preparedness program that meets the requirements of this section. The em ergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan. The hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emerge ncy events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other379

emergencies that would affect the hospice’s ability to provide care. (3) Address patient population, including, but not limited to, the type of services the hospice has the ability to provide in an emer gency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, or Federal emergency preparedness officials’ efforts to ensure an integrated response during a disaster or emergency situa tion, including documentation of the hospice’s

efforts to contact such official s and, when applicable, of its pa rticipation in collaborative and cooperative planning efforts. (b) Policies and procedures

. The hospice must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: (1) A system to track the location of hos pice employees and patients in the hospice’s care both during and after the emergency. (2) Procedures to inform State and local officials about hospice patients in need of evacuation from their residences at any time due to an emergency situation based on the patient’s medical and psychiatric cond ition and home environment. (3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensu res records are secure and readily available. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process a nd role for integration of State and Federally designated health380

care professionals to address surge needs during an emergency. (5) The development of arrangements with other hospices and other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to hospice patients. (6) The following are additional requirements for hospice-operated inpatient care facilities only. The policies and proc edures must address the following: (i) A means to shelter in place for patie nts, hospice employees who remain in the hospice. (ii) Safe evacuation from the hospice, whic h includes consideration of care and treatment needs of evacuees; staff responsibilities; trans portation; identification of evacuation location(s). and primary and alternate means of communicat ion with external sources of assistance. (iii) The provision of subsis tence needs for hospice employees and patients, whether they evacuate or shelter in place, include, but are not limited to the following: (A) Food, water, and medical supplies. (B) Alternate sources of energy to maintain the following: (1 ) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (2 ) Emergency lighting. (3 ) Fire detection, extingui shing, and alarm systems. (C) Sewage and waste disposal. (iv) The role of the hospice under a waiver declared by the Secretar y, in accordance with section 1135 of the Act, in the pr ovision of care and trea tment at an alternate care site identified by emergency management officials.381

(c) Communication plan . The hospice must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing serv ices under arrangement. (iii) Patients’ physicians. (iv) Other hospices. (2) Contact information for the following: (i) Federal, State, trib al, regional, and local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means fo r communicating with the following: (i) Hospice’s employees. (ii) Federal, State, trib al, regional, and local emergency management agencies. (4) A method for sharing information and medical documentation for patients under the hospice’s care, as necessary, with other health ca re providers to ensure continuity of care. (5) A means, in the event of an evacuati on, to release patient information as permitted

under 45 CFR 164.510. (6) A means of providing information a bout the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). (7) A means of providing information about the hospice’s inpatient occupancy, needs, and its ability to provide assist ance, to the authority having ju risdiction, the Incident Command382

Center, or designee. (d) Training and testing. The hospice must develop and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually. (1) Training program. The hospice must do all of the following: (i) Initial training in emer gency preparedness policies and procedures to all new and existing hospice employees, and individuals prov iding services under arrangement, consistent with their expected roles. (ii) Ensure that hospice employees can demonstrate knowledge of emergency procedures. (iii) Provide emergency preparedne ss training at least annually. (iv) Periodically review and rehearse its emergency pr eparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to pr otect patients and others. (v) Maintain documentation of all emergency preparedness training. (2) Testing. The hospice must conduct exercises to test the emergency plan. The hospice must do the following: (i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the hospice experiences an actual natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year followi ng the onset of the actual event. (iii) Conduct a paper-based, tablet op exercise at least annually. A tabletop exercise is a383

group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (iv) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the hospice’s emergency plan, as needed. PART 441—SERVICES: REQUIREMEN TS AND LIMITS APPLICABLE TO

SPECIFIC SERVICES 10. The authority citation for Part 441 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). 11. Add § 441.184 to subpart D to read as follows: § 441.184 Emergency preparedness. The Psychiatric Residential Treatment Facility (PRTF) must comply with all applicable Federal and State emergency prep aredness requirements. The PRTF must establish and maintain an emergency preparedness program that meets th e requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan. The PRTF must develop and ma intain an emergency preparedness plan that must be reviewed, and updated at l east annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emerge ncy events identified by the risk assessment. (3) Address resident population, including, but not limited to, persons at-risk; the type of services the PRTF has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.384

(4) Include a process ensuri ng cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness official s’ efforts to ensure an integrated response during a disaster or emergency situation, incl uding documentation of th e PRTF’s efforts to contact such officials and, when applicable, of its pa rticipation in collab orative and cooperative planning efforts. (b) Policies and procedures . The PRTF must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: (1) The provision of subsistence needs for staff and residents, whether they evacuate or shelter in place, include, but are not limited to the following: (i) Food, water, and medical supplies. (ii) Alternate sources of en ergy to maintain the following: (A) Temperatures to protect resident health and safety a nd for the safe and sanitary storage of provisions. (B) Emergency lighting. (C) Fire detection, extingui shing, and alarm systems. (D) Sewage and waste disposal. (2) A system to track the location of sta ff and residents in the PRTF’s care both during and after the emergency. (3) Safe evacuation from the PRTF, which includes consideration of care and treatment needs of evacuees; staff responsibilities; trans portation; identification of evacuation location(s);385

and primary and alternate means of communicat ion with external sources of assistance. (4) A means to shelter in place for resident s, staff, and volunteers who remain in the facility. (5) A system of medical documentation th at preserves resident information, protects confidentiality of resident information, and ensu res records are secure and readily available. (6) The use of volunteers in an emergenc y or other emergency staffing strategies, including the process an d role for integration of State a nd Federally designated health care professionals to address surg e needs during an emergency. (7) The development of arrangements with other PRTFs and other providers to receive

residents in the event of limitations or cessation of operations to ensure the continuity of services

to PRTF residents. (8) The role of the PRTF under a waiver d eclared by the Secretary, in accordance with section 1135 of Act, in the provi sion of care and treatment at an alternate care site identified by emergency management officials. (c) Communication plan . The PRTF must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing serv ices under arrangement. (iii) Residents’ physicians. (iv) Other PRTFs.386

(v) Volunteers. (2) Contact information for the following: (i) Federal, State, trib al, regional, and local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means for comm unicating with the PRTF’s staff, Federal, State, tribal, regional, and local emergency management agencies. (4) A method for sharing information and medical documentation for residents under the PRTF’s care, as necessary, with other health care providers to ensure continuity of care. (5) A means, in the event of an evacuati on, to release resident information as permitted

under 45 CFR 164.510. (6) A means of providing information about the general condition and location of residents under the facility’s care as permitted under 45 CFR 164.510(b)(4). (7) A means of providing information about the PRTF’s occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, th e Incident Command Center, or designee. (d) Training and testing . The PRTF must develop and maintain an emergency preparedness training program that must be reviewed and updated at least annually. (1) Training program . The PRTF must do all of the following: (i) Provide initial training in emergency pr eparedness policies and procedures to all new and existing staff, individuals providing servic es under arrangement, a nd volunteers, consistent with their expected roles. (ii) After initial training, provide emerge ncy preparedness training at least annually. (iii) Ensure that staff can demonstrat e knowledge of emergency procedures.387

(iv) Maintain documentation of al l emergency preparedness training. (2) Testing. The PRTF must conduct exercises to test the emergency plan. The PRTF must do the following: (i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the PRTF experiences an actual na tural or man-made emergency that requires activation of the emergency plan, the PRTF is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year followi ng the onset of the actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (iv)(A) Analyze the PRTF’s response to and maintain documentation of all drills, tabletop exercises, and emergency events. (B) Revise the PRTF’s emergency plan, as needed. PART 460—PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) 12. The authority citation for part 460 continues to read as follows: Authority: Secs: 1102, 1871, 1894(f), and 1934(f) of the Social Security Act (42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f)). § 460.72 [Amended] 13. Amend § 460.72 by removing paragraph (c). 14. Add § 460.84 to subpart E to read as follows:388

§ 460.84 Emergency preparedness. The Program for the All-Inclusive Care fo r the Elderly (PACE) organization must comply with all applicable Federal and State emergency preparedness requirements. The PACE organization must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan. The PACE organization must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emerge ncy events identified by the risk assessment. (3) Address participant population, including, bu t not limited to, the t ype of services the PACE organization has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situa tion, including documentation of the PACE’s

efforts to contact such official s and, when applicable, of its participation in organization’s collaborative and cooperative planning efforts. (b) Policies and procedures . The PACE organization must develop and implement emergency preparedness policies and procedures , based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the389

communication plan at paragraph (c) of this sec tion. The policies and procedures must address management of medical and nonmedical emerge ncies, including, but not limited to: fire; equipment, power, or water failure; care-relate d emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. Policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: (1) A system to track the location of staff and participants under the PACE center(s) care both during and after the emergency. (2) Safe evacuation from the PACE center, which includes consideration of care and treatment needs of evacuees; sta ff responsibilities; transportati on; identification of evacuation location(s); and primary and alternate means of communication with external sources of

assistance. (3) The procedures to inform State and local emergency preparedness officials about PACE participants in need of evacuation from th eir residences at any time due to an emergency situation based on the patient’s medical and ps ychiatric conditions a nd home environment. (4) A means to shelter in place for particip ants, staff, and volunteers who remain in the facility. (5) A system of medical documentation that preserves participant information, protects confidentiality of patient information, and ensure s records are secure a nd readily available. (6) The use of volunteers in an emergenc y or other emergency staffing strategies, including the process an d role for integration of State or Federally designated health care professionals to address surg e needs during an emergency. (7) The development of arrangements with other PACE organizati ons, PACE centers, or390

other providers to receive participants in the event of limitations or ces sation of operations to ensure the continuity of serv ices to PACE participants. (8) The role of the PACE organization under a waiver de clared by the Secretary, in

accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergenc y management officials. (9)(i) Emergency equipment, including eas ily portable oxygen, airways, suction, and emergency drugs. (ii) Staff who know how to use the equipment must be on the premises of every center at all times and be immediately available. (iii) A documented plan to obtain emergenc y medical assistance from outside sources

when needed. (c) Communication plan. The PACE organization must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for staff; entities providing services under arrangement; participants’ physicians; othe r PACE organizations; and volunteers. (2) Contact information for the following: (i) Federal, State, trib al, regional, and local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means for communicating with the following: (i) PACE organization’s staff. (ii) Federal, State, trib al, regional, and local emergency management agencies.391

(4) A method for sharing information and medical documentation for participants under the organization’s care, as necessa ry, with other health care provide rs to ensure continuity of

care. (5) A means, in the event of an evacua tion, to release partic ipant information as permitted under 45 CFR 164.510. (6) A means of providing information about the general condition and location of participants under the facility’s car e as permitted under 45 CFR 164.510(b)(4). (7) A means of providing information about the PACE organization’s needs, and its ability to provide assistance, to the authorit y having jurisdiction, the Incident Command Center, or designee. (d) Training and testing. The PACE organization must develop and maintain an emergency preparedness training and testing progra m that must be reviewed and updated at least annually. (1) Training program . The PACE organization mu st do all of the following: (i) Initial training in emer gency preparedness policies and procedures to all new and existing staff, individuals providi ng on-site services under arrangeme nt, contractors, participants, and volunteers, consistent w ith their expected roles. (ii) Provide emergency prepare dness training at least annually. (iii) Ensure that staff demonstrate a knowledge of emer gency procedures, including informing participants of what to do, where to go , and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (2) Testing . The PACE organization must conduct ex ercises to test the emergency plan. The PACE organization must do the following:392

(i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the PACE organization experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PA CE organization is exempt from engaging in a community or individual, facility-based mock disa ster drill for 1 year following the onset of the

actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (iv) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed.

PART 482—CONDITIONS OF PARTICIPATION FOR HOSPITALS 15. The authority citation for part 482 continues to read as follows: Authority: Secs. 1102, 1871, and 1881 of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted. 16. Add § 482.15 to subpart B to read as follows: § 482.15 Condition of participatio n: Emergency preparedness. The hospital must comply with all applicable Federal and State emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirement s of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the393

following elements: (a) Emergency plan . The hospital must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emerge ncy events identified by the risk assessment. (3) Address patient population, including, but not limited to, persons at-risk; the type of services the hospital has the abil ity to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situati on, including documentation of the hospital’s

efforts to contact such official s and, when applicable, its part icipation in collaborative and cooperative planning efforts. (b) Policies and procedures . The hospital must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: (1) The provision of subsistence needs for staff and patients, whether they evacuate or shelter in place, include, but are not limited to the following: (i) Food, water, and medical supplies.394

(ii) Alternate sources of en ergy to maintain the following: (A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (B) Emergency lighting. (C) Fire detection, extingui shing, and alarm systems. (D) Sewage and waste disposal. (2) A system to track the location of sta ff and patients in the hos pital’s care both during and after the emergency. (3) Safe evacuation from the hospital, whic h includes consideration of care and treatment needs of evacuees; staff responsibilities; trans portation; identification of evacuation location(s); and primary and alternate means of communicat ion with external sources of assistance. (4) A means to shelter in place for patient s, staff, and volunteers who remain in the facility. (5) A system of medical documentation th at preserves patient information, protects confidentiality of patient information, and ensure s records are secure a nd readily available. (6) The use of volunteers in an emergenc y and other emergency staffing strategies, including the process an d role for integration of State a nd Federally designated health care professionals to address surg e needs during an emergency. (7) The development of arrangements with ot her hospitals and other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to hospital patients. (8) The role of the hospital under a waiver declared by the Secretary , in accordance with section 1135 of the Act, in the pr ovision of care and trea tment at an alternate care site identified395

by emergency management officials. (c) Communication plan . The hospital must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing servi ces under arrangement. (iii) Patients’ physicians. (iv) Other hospitals (v) Volunteers. (2) Contact information for the following: (i) Federal, State, trib al, regional, and local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means fo r communicating with the following: (i) Hospital’s staff. (ii) Federal, State, trib al, regional, and local emergency management agencies. (4) A method for sharing information and medical documentation for patients under the hospital’s care, as necessary, with other health care providers to ensure continuity of care. (5) A means, in the event of an evacuati on, to release patient information as permitted

under 45 CFR 164.510. (6) A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4).396

(7) A means of providing information a bout the hospital’s occupancy, needs, and its ability to provide assistance, to the authorit y having jurisdiction, the Incident Command Center, or designee. (d) Training and testing . The hospital must develop and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually. (1) Training program . The hospital must do all of the following: (i) Initial training in emer gency preparedness policies and procedures to all new and existing staff, individuals provi ding services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency prepare dness training at least annually. (iii) Maintain documentation of the training. (iv) Ensure that staff can demonstrat e knowledge of emergency procedures. (2) Testing. The hospital must conduct drills and ex ercises to test the emergency plan. The hospital must do all of the following: (i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the hospital experiences an actual natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year followi ng the onset of the actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge397

an emergency plan. (iv) Analyze the hospital’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the hospital’s emergency plan, as needed. (e) Emergency and standby power systems . The hospital must implement emergency and standby power systems based on the emergency pl an set forth in paragra ph (a) of this section and in the policies and procedures plan set forth in paragraphs (b)(2)(i) an d (ii) of this section. (1) Emergency generator location . (i) The generator must be located in accordance with the location requirements found in NFPA 99, NFPA 101, and NFPA 110. (2) Emergency generato r inspection and testing . In addition to the emergency power system inspection and testing requirements found in NFPA 99 – Health Care Facilities and NFPA 110 – Standard for Emergency and Standby Power systems, as referenced by NFPA 101 – Life Safety Code (as required by 42 CFR 482.41(b)), the hospital must: (i) At least once every 12 months, test each emergency generator for a minimum of 4 continuous hours. The emergency generator test load must be 100 percent of the load the hospital anticipates it will require during an emergency. (ii) Maintain a written record, which is av ailable upon request, of generator inspections, tests, exercising, opera tion and repairs. (3) Emergency generator fuel . Hospitals that maintain an onsite fuel source to power emergency generators must main tain a quantity of fuel capable of sustaining emergency power

for the duration of the emer gency or until likely resupply. 17. Add § 482.78 to subpart E to read as follows: § 482.78 Condition of participation: Emergen cy preparedness for transplant centers. A transplant center must have policies and procedures that address emergency398

preparedness. (a) Standard: Agreement with at least one Medicare approved transplant center. A transplant center or the hospital in which it ope rates must have an agreement with at least one other Medicare-approved transplant center to provide transplantat ion services and related care for its patients during an emergency. The agreem ent must address the following, at a minimum: (1) Circumstances under which the agreement will be activated. (2) Types of services that will be provided during an emergency. (b) Standard: Agreement with the Organ Procur ement Organization (OPO) designated by the Secretary. The transplant center must en sure that the written agreement required under § 482.100 addresses the duties and responsibilitie s of the hospital and the OPO during an

emergency. PART 483—REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES 18. The authority citation for part 483 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Secu rity Act (42 U.S.C. 1302 and 1395hh). 19. Add § 483.73 to subpart B to read as follows: § 483.73 Emergency preparedness. The LTC facility must comply with all applicable Federal and State emergency preparedness requirements. The LTC facility must establish and maintain an emergency preparedness program that meets the requirement s of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must: (1) Be based on and include a documented, facility-based and community-based risk399

assessment, utilizing an all-hazards approach, including missing residents; (2) Include strategies for addressing emer gency events identified by the risk assessment; (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion 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 LTC facility’s

efforts to contact such official s and, when applicable, of its pa rticipation in collaborative and cooperative planning efforts. (b) Policies and procedures . The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: (1) The provision of subsistence needs for staff and residents, whether they evacuate or shelter in place, include, but are not limited to: (i) Food, water, and medical supplies; (ii) Alternate sources of energy to maintain: (A) Temperatures to protect resident health and safety a nd for the safe and sanitary storage of provisions; (B) Emergency lighting; (C) Fire detection, extinguish ing, and alarm systems, and;400

(D) Sewage and waste disposal. (2) A system to track the location of staff and residents in the LTC facility’s care both during and after the emergency. (3) Safe evacuation from the LTC facil ity, which includes consideration of care and treatment needs of evacuees; sta ff responsibilities; transportati on; identification of evacuation location(s); and primary and alternate means of communication with external sources of

assistance. (4) A means to shelter in place for resident s, staff, and volunteers who remain in the LTC facility. (5) A system of medical documentation that preserves resident information, protects confidentiality of resident information, and ensu res records are secure and readily available. (6) The use of volunteers in an emergenc y or other emergency staffing strategies, including the process an d role for integration of State or Federally designated health care professionals to address surg e needs during an emergency. (7) The development of arrangements with other LTC facilities and other providers to

receive residents in the event of limitations or cessa tion of operations to en sure the continuity of

services to LTC residents. (8) The role of the LTC fac ility under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials. (c) Communication plan . The LTC facility must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the401

following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing serv ices under arrangement. (iii) Residents’ physicians. (iv) Other LTC facilities. (v) Volunteers. (2) Contact information for the following: (i) Federal, State, trib al, regional, or local emer gency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the Stat e Long-Term Care Ombudsman. (iv) Other sources of assistance. (3) Primary and alternate means for communicating with the following: (i) LTC facility’s staff. (ii) Federal, State, trib al, regional, or local emerge ncy management agencies. (4) A method for sharing information and medical documentation for residents under the LTC facility’s care, as necessary, with other health care providers to ensure continuity of care. (5) A means, in the event of an evacuati on, to release resident information as permitted

under 45 CFR 164.510. (6) A means of providing information about the general condition and location of residents under the facility’s care as permitted under 45 CFR 164.510(b)(4). (7) A means of providing information about the LTC facility’s occupancy, needs, and its ability to provide assistance, to the author ity having jurisdiction or the Incident Command402

Center, or designee. (8) A method for sharing information from the emergency plan that the facility has determined is appropriate with residents and their families or representatives. (d) Training and testing . The LTC facility must develop and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually. (1) Training program . The LTC facility must do all of the following: (i) Initial training in emer gency preparedness policies and procedures to all new and existing staff, individuals provi ding services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency prepare dness training at least annually. (iii) Maintain documentation of the training. (iv) Ensure that staff can demonstr ate knowledge of emergency procedures. (2) Testing . The LTC facility must conduct drills and exercises to test the emergency plan, including unannounced staff drills using the em ergency procedures. The LTC facility must do the following: (i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the LTC facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging in a community or individual, facility-based mock disa ster drill for 1 year following the onset of the

actual event. (iii) Conduct a paper-based, tablet op exercise at least annually. A tabletop exercise is a403

group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (iv) Analyze the LTC facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the LTC facility’s emergency plan, as

needed. (e) Emergency and standby power systems . The LTC facility must implement emergency and standby power systems based on the em ergency plan set forth in paragraph (a) of

this section. (1) Emergency generator location . (i) The generator must be located in accordance with the location requirements found in NFPA 99 and NFPA 100. (2) Emergency generato r inspection and testing . In addition to the emergency power system inspection and testing requirements found in NFPA 99 – Health Care Facilities and NFPA 110 – Standard for Emergency and Stand by Power Systems, as referenced by NFPA 101 – Life Safety Code as required under paragraph (a ) of this section, the LTC facility must do the following: (i) At least once every 12 months test each emergency generator for a minimum of 4 continuous hours. The emergency generator test load must be 100 percent of the load the LTC facility anticipates it will require during an emergency. (ii) Maintain a written record, which is av ailable upon request, of generator inspections, tests, exercising, ope ration and repairs. (3) Emergency generator fuel . LTC facilities that maintain an onsite fuel source to power emergency generators must maintain a qua ntity of fuel capable of sustaining emergency404

power for the duration of the emergency or until likely resupply.

§ 483.75 [Amended] 20. Amend § 483.75 by removing and reserving paragraph (m).

§ 483.470 [Amended] 21. Amend § 483.470 by-- A. Removing paragraph (h). B. Redesignating paragraphs (i) through (l) as paragraphs (h) through (k), respectively. C. Newly redesginated paragraph (h)( 3) is amended by removing the reference "paragraphs (i)(1) and (2)" and adding in its place the reference "paragraphs (h)(1) and (2)". 22. Add § 483.475 to subpart I to read as follows: § 483.475 Condition of participation: Emergency preparedness. The Intermediate Care Facility for Individua ls with Intellectual Disabilities (ICF/IID) must comply with all applicable Federal and St ate emergency preparedness requirements. The

ICF/IID must establish and maintain an em ergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and upda ted at least annually. The plan must do all of the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazard s approach, including missing clients.405

(2) Include strategies for addressing emerge ncy events identified by the risk assessment. (3) Address the special needs of its c lient population, includi ng, but not limited to, persons at-risk; the type of serv ices the ICF/IID has th e ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situa tion, including documentation of the ICF/IID

efforts to contact such official s and, when applicable, of its pa rticipation in collaborative and cooperative planning efforts. (b) Policies and procedures. The ICF/IID must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: (1) The provision of subsistence needs for st aff and residents, whether they evacuate or shelter in place, include, but are not limited to the following: (i) Food, water, and medical supplies. (ii) Alternate sources of en ergy to maintain the following: (A) Temperatures to protect resident health and safety a nd for the safe and sanitary storage of provisions. (B) Emergency lighting. (C) Fire detection, extingui shing, and alarm systems. (D) Sewage and waste disposal.406

(2) A system to track the location of staff and residents in the ICF/ IID’s care both during and after the emergency. (3) Safe evacuation from the ICF/IID, which includes consideration of care and treatment needs of evacuees; sta ff responsibilities; transportati on; identification of evacuation location(s); and primary and alternate means of communication with external sources of

assistance. (4) A means to shelter in place for client s, staff, and volunteers who remain in the facility. (5) A system of medical documentation th at preserves client information, protects confidentiality of client information, and ensure s records are secure a nd readily available. (6) The use of volunteers in an emergenc y or other emergency staffing strategies, including the process an d role for integration of State or Federally designated health care professionals to address surg e needs during an emergency. (7) The development of arrangements with other ICF/IIDs or other providers to receive clients in the event of limitations or cessation of ope rations to ensure the con tinuity of services to

ICF/IID clients. (8) The role of the ICF/IID under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the pr ovision of care and trea tment at an alternate care site identified by emergency management officials. (c) Communication plan. The ICF/IID must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The co mmunication plan must include the following: (1) Names and contact information for the following:407

(i) Staff. (ii) Entities providing se rvices under arrangement. (iii) Clients’ physicians. (iv) Other ICF/IIDs. (v) Volunteers. (2) Contact information for the following: (i) Federal, State, tr ibal, regional, and local em ergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. (3) Primary and alternate means for communi cating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. (4) A method for sharing information a nd medical documentation for clients under the ICF/IID’s care, as necessary, with other health care providers to ensure continuity of care. (5) A means, in the event of an evacuati on, to release client information as permitted

under 45 CFR 164.510. (6) A means of providing information about the general condition and location of clients under the facility’s care as permitted under 45 CFR 164.510(b)(4). (7) A means of providing information a bout the ICF/IID’s occupancy, needs, and its ability to provide assistance, to the authorit y having jurisdiction, the Incident Command Center, or designee. (8) A method for sharing information from the emergency plan that the facility has determined is appropriate with clients and their families or representatives.408

(d) Training and testing . The ICF/IID must develop and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually. The ICF/IID must meet the requirements for evacuation drills and training at § 483.470(h). (1) Training program . The ICF/IID must do all the following: (i) Initial training in em ergency preparedness policies and procedures to all new and existing staff, individuals provi ding services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency prepare dness training at least annually. (iii) Maintain documentation of the training. (iv) Ensure that staff can demonstr ate knowledge of emergency procedures. (2) Testing. The ICF/IID must conduct exercises to test the emergency plan. The ICF/IID must do the following: (i) Participate in a community mock disa ster drill at least annua lly. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in a community or individual, facility-b ased mock disaster drill for 1 year fo llowing the onset of the actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan.409

(iv) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed.

PART 484--HOME HEALTH SERVICES 23. The authority citation for part 484 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)) unless otherwise indicated. 24. Add § 484.22 to subpart B to read as follows: § 484.22 Condition of participatio n: Emergency preparedness. The Home Health Agency (HHA) must comply with all applicable Federal and State emergency preparedness requirements. The HHA must establish and maintain an emergency preparedness program that meets the requirement s of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan . The HHA must develop and main tain an emergency preparedness plan that must be reviewed, and update d at least annually. The plan must: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach; (2) Include strategies for addressing emerge ncy events identified by the risk assessment; (3) Address patient population, including, but not limited to, the type of services the HHA has the ability to provide in an emergenc y; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the HHA’s efforts410

to contact such officials and, when applicable , of its participation in collaborative and cooperative planning efforts. (b) Policies and procedures

. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: (1) The plans for the HHA’s patients during a na tural or man-made di saster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at § 484.55. (2) The procedures to inform State and local emergency preparedness officials about HHA patients in need of evacuation from their residences at any time due to an emergency situation based on the patient’s medical and ps ychiatric condition and home environment. (3) A system to track the location of staff and patients in the HHA’s care both during and after the emergency. (4) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensu res records are secure and readily available. (5) The use of volunteers in an emergenc y or other emergency staffing strategies, including the process an d role for integration of State or Federally designated health care professionals to address surg e needs during an emergency. (6) The development of arrangements with other HHAs or other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to HHA patients.411

(c) Communication plan . The HHA must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing serv ices under arrangement. (iii) Patients’ physicians. (iv) Other HHAs. (v) Volunteers. (2) Contact information for the following: (i) Federal, State, trib al, regional, or local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means for communica ting with the HHA’s staff, Federal, State, tribal, regional, and local emer gency management agencies. (4) A method for sharing information and me dical documentation for patients under the HHA’s care, as necessary, with other health car e providers to ensure continuity of care. (5) A means of providing information a bout the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4).. (6) A means of providing information about the HHA’s needs, and its ability to provide assistance, to the authority ha ving jurisdiction, the Incident Co mmand Center, or designee. (d) Training and testing . The HHA must develop and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually.412

(1) Training program . The HHA must do all of the following: (i) Initial training in emer gency preparedness policies and procedures to all new and existing staff, individuals provi ding services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency prepare dness training at least annually. (iii) Maintain documentation of the training. (ii) Ensure that staff can demonstrat e knowledge of emergency procedures. (2) Testing . The HHA must conduct drills and exerci ses to test the emergency plan. The HHA must do the following: (i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the HHA experiences an actual na tural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year followi ng the onset of the actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (iv) Analyze the HHA’s response to and main tain documentation of all drills, tabletop exercises, and emergency events, and revi se the HHA’s emergency plan, as needed.

PART 485--CONDITIONS OF PARTICIP ATION: SPECIALIZED PROVIDERS 25. The authority citation for part 485 continues to read as follows:413

Authority: Secs. 1102 and 1871 of the Social Se curity Act (42 U.S.C. 1302 and 1395(hh)). § 485.64 [Removed] 26. Remove § 485.64. 27. Add § 485.68 to subpart B to read as follows: § 485.68 Condition of participatio n: Emergency preparedness. The Comprehensive Outpatient Rehabilitation Facility (CORF) must comply with all applicable Federal and State emergency prepare dness requirements. The CORF must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must in clude, but not be limited to, the following

elements: (a) Emergency plan . The CORF must develop and maintain an emergency preparedness plan that must be reviewed and update d at least annually. The plan must: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach; (2) Include strategies for addressing emerge ncy events identified by the risk assessment; (3) Address patient population, including, but not limited to, the type of services the CORF has the ability to provide in an emer gency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situa tion, including documentation of the CORF’s414

efforts to contact such official s and, when applicable, of its pa rticipation in collaborative and cooperative planning efforts; (5) Be developed and maintained with assist ance from fire, safet y, and other appropriate

experts. (b) Policies and procedures

. The CORF must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: (1) Safe evacuation from the CORF, which in cludes staff responsibil ities, and needs of the patients. (2) A means to shelter in place for patient s, staff, and volunteers who remain in the facility. (3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensure s records are secure a nd readily available. (4) The use of volunteers in an emergenc y and other emergency staffing strategies, including the process an d role for integration of State or Federally designated health care professionals to address surg e needs during an emergency. (c) Communication plan . The CORF must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following:415

(i) Staff. (ii) Entities providing serv ices under arrangement. (iii) Patients’ physicians. (iv) Other CORFs. (v) Volunteers. (2) Contact information for the following: (i) Federal, State, trib al, regional and local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means for communi cating with the CORF’s staff, Federal, State, tribal, regional, and local emergency management agencies. (4) A method for sharing information and me dical documentation for patients under the CORF’s care, as necessary, with other health ca re providers to ensure continuity of care. (5) A means of providing information about th e CORF’s needs, and its ability to provide assistance, to the authority ha ving jurisdiction or the Incident Command Center , or designee. (d) Training and testing . The CORF must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually. (1) Training program . The CORF must do all of the following: (i) Provide initial training in emergency pr eparedness policies and procedures to all new and existing staff, individuals providing servic es under arrangement, a nd volunteers, consistent with their expected roles. (ii) Provide emergency preparedne ss training at least annually. (iii) Maintain documentation of the training.416

(iv) The CORF must ensure that sta ff can demonstrate knowledge of emergency procedures. All new personnel must be oriented and assigned specific re sponsibilities regarding the CORF’s emergency plan within two weeks of their first workday. The training program must

include instruction in the location and use of alarm systems and signals and fire fighting equipment. (2) Testing . The CORF must conduct drills and ex ercises to test the emergency plan. The CORF must do the following: (i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the CORF experiences an actual na tural or man-made emergency that requires activation of the emergency plan, the CORF is exempt from engaging in a community or individual, facility-b ased mock disaster drill for 1 year follo wing the onset of the actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (iv) Analyze the CORF’s response to and ma intain documentation of all drills, tabletop exercises, and emergency events, and revise the CORF’s emergency plan, as needed. § 485.623 [Amended] 28. Amend § 485.623 by removing paragraph (c ) and redesignating paragraph (d) as paragraph (c). 29. Add § 485.625 to subpart F to read as follows:417

§ 485.625 Condition of participation: Emergency preparedness. The Critical Access Hospital (CAH) must comply with all applicable Federal and State emergency preparedness requirements. The C AH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness plan must include, but not be limited to, the following elements: (a) Emergency plan . The CAH must develop and main tain an emergency preparedness plan that must be reviewed and update d at least annually. The plan must: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach; (2) Include strategies for addressing emerge ncy events identified by the risk assessment; (3) Address patient population, including, but no t limited to, persons at-risk; the type of services the CAH has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the CAH’s efforts to contact such officials and, when applicable , of its participation in collaborative and cooperative planning efforts. (b) Policies and procedures

. The CAH must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and pr ocedures must address the following:418

(1) The provision of subsistence needs for staff and patients, whether they evacuate or shelter in place, include, but are not limited to: (i) Food, water, and medical supplies; (ii) Alternate sources of energy to maintain: (A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions; (B) Emergency lighting; (C) Fire detection, extinguish ing, and alarm systems; and (D) Sewage and waste disposal. (2) A system to track the location of staff and patients in the CAH’ s care both during and after the emergency. (3) Safe evacuation from the CAH, which in cludes consideration of care and treatment needs of evacuees; staff responsibilities; trans portation; identification of evacuation location(s); and primary and alternate means of communicat ion with external sources of assistance. (4) A means to shelter in place for patient s, staff, and volunteers who remain in the facility. (5) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensure s records are secure a nd readily available. (6) The use of volunteers in an emergenc y or other emergency staffing strategies, including the process an d role for integration of State or Federally designated health care professionals to address surg e needs during an emergency.419

(7) The development of arrangements with other CAHs or other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to CAH patients. (8) The role of the CAH under a waiver decl ared by the Secretar y, in accordance with section 1135 of the Act, in the pr ovision of care and trea tment at an alternate care site identified by emergency management officials. (c) Communication plan . The CAH must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing serv ices under arrangement. (iii) Patients’ physicians. (iv) Other CAHs. (v) Volunteers. (2) Contact information for the following: (i) Federal, State, trib al, regional, and local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means fo r communicating with the following: (i) CAH’s staff. (ii) Federal, State, trib al, regional, and local emergency management agencies.420

(4) A method for sharing information and me dical documentation for patients under the CAH’s care, as necessary, with other health car e providers to ensure continuity of care. (5) A means, in the event of an evacuati on, to release patient information as permitted

under 45 CFR 164.510. (6) A means of providing information a bout the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). (7) A means of providing information about the CAH’s occupancy, needs, and its ability to provide assistance, to the au thority having jurisdiction or th e Incident Command Center, or designee. (d) Training and testing . The CAH must develop and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually. (1) Training program . The CAH must do all of the following: (i) Initial training in emer gency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire preven tion, and cooperation with fire fi ghting and disaster authorities, to all new and existing staff, individuals prov iding services under arra ngement, and volunteers, consistent with their expected roles. (ii) Provide emergency prepare dness training at least annually. (iii) Maintain documentation of the training. (iv) Ensure that staff can demonstrat e knowledge of emergency procedures. (2) Testing . The CAH must conduct exercises to test the emergency plan. The CAH must do the following:421

(i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the CAH experiences an actual na tural or man-made emergency that requires activation of the emergency plan, the CAH is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year followi ng the onset of the actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (iv) Analyze the CAH’s response to and main tain documentation of all drills, tabletop exercises, and emergency events, and revi se the CAH’s emergency plan, as needed. (e) Emergency and standby power systems . The CAH must implement emergency and standby power systems based on the emergency plan set forth in paragraph (a) of this section. (1) Emergency generator location . (i) The generator must be located in accordance with the location requirements found in NFPA 99 and NFPA 100. (2) Emergency generato r inspection and testing . In addition to the emergency power system inspection and testing requirements found in NFPA 99 – Health Care Facilities and NFPA 110 – Standard for Emergency and Stand by Power Systems, as referenced by NFPA 101 – Life Safety Code (as required by 42 CFR 485. 623(d)), the CAH must do all of the following: (i) At least once every 12 months test each emergency generator for a minimum of 4 continuous hours. The emergency generator test load must be 100 percent of the load the CAH anticipates it will require during an emergency.422

(ii) Maintain a written record, which is av ailable upon request, of generator inspections, tests, exercising, ope ration, and repairs. (3) Emergency generator fuel . Hospitals that maintain an onsite fuel source to power emergency generators must main tain a quantity of fuel capable of sustaining emergency power

for the duration of the emer gency or until likely resupply. 30. Revise § 485.727 to read as follows: § 485.727 Condition of participation: Emergency preparedness. The Clinics, Rehabilitation Agencies, and P ublic Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services ("Organizations") must comply with all applicable Federal and Stat e emergency preparedness requirements. The Organizations must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan . The Organizations must develop and maintain an emergency preparedness plan that must be reviewed and upda ted at least annually. The plan must do all of the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergenc y events identified by the risk assessment. (3) Address patient population, including, but not limited to, the type of services the Organizations have the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.423

(4) Address the location and use of al arm systems and signals; and methods of containing fire. (5) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situation. (6) Be developed and maintained with assist ance from fire, safet y, and other appropriate

experts. (b) Policies and procedures

. The Organizations must develop and implement emergency preparedness policies and procedures , based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this se ction. The policies and procedures must be reviewed and updated at least annually. At a mini mum, the policies and procedures must address the following: (1) Safe evacuation from the Organizations, which includes staff responsibilities, and needs of the patients. (2) A means to shelter in place for patient s, staff, and volunteers who remain in the facility. (3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensure s records are secure and readily available. (4) The use of volunteers in an emergenc y or other emergency staffing strategies, including the process an d role for integration of State a nd Federally designated health care professionals to address surg e needs during an emergency.424

(c) Communication plan . The Organizations must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing serv ices under arrangement. (iii) Patients’ physicians. (iv) Other Organizations. (v) Volunteers. (2) Contact information for the following: (i) Federal, state, trib al, regional and local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means fo r communicating with the following: (i) Organizations’ staff. (ii) Federal, state, tribal, regional, and local emergency management agencies. (4) A method for sharing information and me dical documentation for patients under the Organizations’ care, as necessary, w ith other health care providers to ensure continuity of care. (5) A means of providing information about th e Organizations’ needs, and their ability to provide assistance, to the aut hority having jurisdiction or th e Incident Command Center, or designee. (d) Training and testing . The Organizations must deve lop and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually.425

(1) Training program . The Organizations must do all of the following: (i) Initial training in emer gency preparedness policies and procedures to all new and existing staff, individuals provi ding services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency prepare dness training at least annually. (iii) Maintain documentation of the training. (iv) The Organizations must ensure that staff can dem onstrate knowledge of emergency procedures. (2) Testing . The Organizations must conduct drills and exercises to test the emergency plan. The Organizations must do the following: (i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the Organizations experience an actual natural or man-made emergency that requires activation of the emergency plan, they are exempt from engaging in a community or individual, facility-b ased mock disaster drill for 1 year fo llowing the onset of the actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (iv) Analyze the Organization’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, a nd revise their emergency plan, as needed.426

31. Section 485.920 is added to Subpart J (as added on October 29, 2013, at 78

FR 64630 and effective on October 29, 2014) to read as follows:: §485.920 Condition of participation: Emergency preparedness. The Community Mental Health Center (CMHC) must comply with all applicable federal and state emergency preparedness requirements. The CMHC must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan . The CMHC must develop and maintain an emergency preparedness plan that must be reviewed, a nd updated at least annuall y. The plan must do all of the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emerge ncy events identified by the risk assessment. (3) Address client population, including, but not limited to, the t ype of services the CMHC has the ability to provide in an emer gency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situa tion, including documentation of the CMHC’s

efforts to contact such official s and, when applicable, of its pa rticipation in collaborative and cooperative planning efforts. (b) Policies and procedures . The CMHC must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at427

paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and pr ocedures must address the following: (1) A system to track the location of st aff and clients in the CMHC’s care both during and after the emergency. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; trans portation; identification of evacuation location(s); and primary and alternate means of communicat ion with external sources of assistance. (3) A means to shelter in place for client s, staff, and volunteers who remain in the facility. (4) A system of medical documentation th at preserves client information, protects confidentiality of client information, and ensure s records are secure and readily available. (5) The use of volunteers in an emergenc y or other emergency staffing strategies, including the process an d role for integration of state or federally designated health care professionals to address surg e needs during an emergency. (6) The development of arrangements with other CMHCs or other providers to receive clients in the event of limitations or cessation of ope rations to ensure the con tinuity of services to

CMHC clients. (7) The role of the CMHC under a waiver declared by the Secr etary of Health and Human Services, in accordance with section 1135 of the Social Security Act, in the provision of

care and treatment at an alternate care site id entified by emergency management officials. (c) Communication plan . The CMHC must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be428

reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing serv ices under arrangement. (iii) Clients’ physicians. (iv) Other CMHCs. (v) Volunteers. (2) Contact information for the following: (i) Federal, State, trib al, regional, and local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means fo r communicating with the following: (i) CMHC’s staff. (ii) Federal, State, trib al, regional, and local emergency management agencies. (4) A method for sharing information a nd medical documentation for clients under the CMHC’s care, as necessary, with other health ca re providers to ensure continuity of care. (5) A means, in the event of an evacuati on, to release client information as permitted

under 45 CFR 164.510. (6) A means of providing information about the general condition and location of clients under the facility’s care as permitted under 45 CFR 164.510(b)(4). (7) A means of providing information a bout the CMHC’s needs, and its ability to provide assistance, to the aut hority having jurisdiction or th e Incident Command Center, or designee.429

(d) Training and testing . The CMHC must develop and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually. (1) Training . The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals prov iding services under arrangement, and volunteers, consis tent with their expected roles, and maintain documentation of the training. The CMHC must ensure that staff can demonstrate knowledge of emergency procedures. Thereafter, the CMHC must provi de emergency preparedne ss training at least annually. (2) Testing . The CMHC must conduct drills and ex ercises to test the emergency plan.

The CMHC must: (i) Participate in a community mock disa ster drill at least annua lly. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the CMHC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CMHC is exempt from engaging in a community or individual, facility-b ased mock disaster drill for 1 year fo llowing the onset of the actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (iv) Analyze the CMHC’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CMHC’s emergency plan, as needed.430

PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES

FURNISHED BY SUPPLIERS 32. The authority citation for part 486 continues to read as follows: Authority: Secs. 1102, 1138, and 1871 of the Social Security Act (42 U.S.C. 1302, 1320b-8, and 1395hh) and section 371 of the Public Health Se rvice Act (42 U.S.C 273). 33. Add § 486.360 to subpart G to read as follows: § 486.360 Condition of participation: Emergency preparedness. The Organ Procurement Organization (OPO) mu st comply with all applicable Federal and State emergency preparedne ss requirements. The OPO must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan . The OPO must develop and main tain an emergency preparedness plan that must be reviewed and updated at least annually. The plan must do all of the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergenc y events identified by the risk assessment. (3) Address the type of hospitals with which the OPO has agreements; the type of services the OPO has the capacity to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the OPO’s efforts431

to contact such officials and, when applicable , of its participation in collaborative and cooperative planning efforts. (b) Policies and procedures

. The OPO must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and, the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and pr ocedures must address the following: (1) A system to track the location of staff during and after an emergency. (2) A system of medical documentation th at preserves poten tial and actual donor information, protects confidentiality of poten tial and actual donor information, and ensures records are secure and readily available. (c) Communication plan . The OPO must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing serv ices under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). (2) Contact information for the following: (i) Federal, State, trib al, regional, and local emer gency preparedness staff.432

(ii) Other sources of assistance. (3) Primary and alternate means fo r communicating with the following: (i) OPO’s staff. (ii) Federal, State, trib al, regional, and local emergency management agencies. (d) Training and testing . The OPO must develop and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually. (1) Training . The OPO must do all of the following: (i) Initial training in emer gency preparedness policies and procedures to all new and existing staff, individuals provi ding services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency prepare dness training at least annually. (iii) Maintain documentation of the training. (iv) The OPO must ensure that sta ff can demonstrate knowledge of emergency procedures. (2) Testing . The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A ta bletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (ii) Analyze the OPO’s response to and main tain documentation of all tabletop exercises, and emergency events, and revise th e OPO’s emergency plan, as needed.433

(e) Agreements with other OPOs and hospitals . Each OPO must have an agreement(s)

with one or more other OPOs to provide essential organ procurem ent services to all or a portion

of the OPO’s Donation Service Area in the event that the OPO cannot provide such services due to an emergency. Each OPO must include w ithin the hospital agre ements required under § 486.322(a) and in the protocols with tran splant programs required under § 486.344(d), the duties and responsibilities of the hospital, transplant program, and the OPO in the event of an

emergency. PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES 34. The authority citation for part 491 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302); and sec. 353 of the Public Health Service Act (42 U.S.C. 263a). § 491.6 [Amended] 35. Amend § 491.6 by removing paragraph (c). 36. Add § 491.12 to read as follows: § 491.12 Condition of participation: Emergency preparedness. The Rural Health Clinic/Federally Qualifie d Health Center (RHC/FQHC) must comply with all applicable Federal and State emergenc y preparedness requirements. The RHC/FQHC must establish and maintain an emergency prepar edness program that meets the requirements of this section. The emergency preparedness progr am must include, but not be limited to, the following elements: (a) Emergency plan . The RHC/FQHC must develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. The plan must:434

(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach; (2) Include strategies for addressing emerge ncy events identified by the risk assessment; (3) Address patient population, including, but not limited to, the type of services the RHC/FQHC has the ability to provide in an em ergency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated response during a disaster or emergency situati on, including documentation of the RHC/FQHC’s

efforts to contact such official s and, when applicable, of its pa rticipation in collaborative and cooperative planning efforts. (b) Policies and procedures

. The RHC/FQHC must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this secti on, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and pr ocedures must address the following: (1) Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. (2) A means to shelter in place for patients, staff, and volunteers who remain in the facility. (3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensure s records are secure a nd readily available.435

(4) The use of volunteers in an emergenc y or other emergency staffing strategies, including the process an d role for integration of State a nd Federally designated health care professionals to address surg e needs during an emergency. (c) Communication plan . The RHC/FQHC must devel op and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing serv ices under arrangement. (iii) Patients’ physicians. (iv) Other RHCs/FQHCs. (v) Volunteers. (2) Contact information for the following: (i) Federal, State, trib al, regional, and local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means fo r communicating with the following: (i) RHC/FQHC’s staff. (ii) Federal, State, trib al, regional, and local emergency management agencies. (4) A means of providing information a bout the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4).436

(5) A means of providing information about the RHC/FQHC’s needs, and its ability to provide assistance, to the aut hority having jurisdiction or th e Incident Command Center, or designee. (d) Training and testing . The RHC/FQHC must devel op and maintain an emergency preparedness training and testing program that mu st be reviewed and updated at least annually. (1) Training program . The RHC/FQHC must do a ll of the following: (i) Initial training in emer gency preparedness policies and procedures to all new and existing staff, individuals provi ding services under arrangement, and volunteers, consistent with their expected roles, (ii) Provide emergency prepare dness training at least annually. (iii) Maintain documentation of the training. (iv) Ensure that staff can demonstrat e knowledge of emergency procedures. (2) Testing . The RHC/FQHC must conduct exercise s to test the emergency plan. The RHC/FQHC must do the following: (i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the RHC/FQHC experiences an act ual natural or man-made emergency that requires activation of the emergency plan, th e RHC/FQHC is exempt from engaging in a community or individual, facility-based mock disa ster drill for 1 year following the onset of the

actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario,437

and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (iv) Analyze the RHC/FQHC’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the RHC/FQHC’s emergency plan, as

needed.

PART 494--CONDITIONS FOR COVERAGE FOR END–STAGE RENAL DISEASE

FACILITIES 37. The authority citation for part 494 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Securi ty Act (42 U.S.C. l302 and l395hh). § 494.60 [Amended] 38. Amend § 494.60 by-- A. Removing paragraph (d). B. Redesignating paragraph (e) is as paragraph (d). 39. Add § 494.62 to subpart B to read as follows: § 494.62 Condition of participatio n: Emergency preparedness. The dialysis facility must comply with all applicable Federa l and State emergency preparedness requirements. These emergencies in clude, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geogra phic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan

. The dialysis facility must develop and maintain an emergency preparedness plan that must be evaluated a nd updated at least annually. The plan must:438

(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach; (2) Include strategies for addressing emerge ncy events identified by the risk assessment; (3) Address patient population, including, but not limited to, the type of services the dialysis facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for ensuring coopera tion and collaboration with local, tribal, regional, State, and Federal emergency preparedne ss officials’ efforts to ensure an integrated response during a disaster or emergency situati on, including documentation of the dialysis facility’s efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts. The dialysis facility must contact the local emergency preparedness agency at least annually to ensure that the ag ency is aware of the dialysis facility’s needs in the event of an emergency. (b) Policies and procedures

. The dialysis facility mu st develop and implement emergency preparedness policies and procedures , based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this se ction. The policies and procedures must be reviewed and updated at least annually. These em ergencies include, but ar e not limited to, fire, equipment or power failures, care-related emer gencies, water supply in terruption, and natural disasters likely to occur in th e facility’s geographic area. At a minimum, the policies and procedures must address the following: (1) A system to track the location of staff a nd patients in the dialysis facility’s care both during and after the emergency.439

(2) Safe evacuation from the dialysis facil ity, which includes staff responsibilities, and needs of the patients. (3) A means to shelter in place for patient s, staff, and volunteers who remain in the facility. (4) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensure s records are secure a nd readily available. (5) The use of volunteers in an emergenc y or other emergency staffing strategies, including the process an d role for integration of State or Federally designated health care professionals to address surg e needs during an emergency. (6) The development of arrangements with othe r dialysis facilities or other providers to receive patients in the event of limitations or ces sation of operations to ensure the continuity of services to dialysis facility patients. (7) The role of the dialysis facility under a waiver declared by the Secretary, in

accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergenc y management officials. (8) A process to ensure that emergency me dical system assistance can be obtained when

needed. (9) A process ensuring that emergency equi pment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator , artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. (c) Communication plan

. The dialysis facility must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be440

reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing serv ices under arrangement. (iii) Patients’ physicians. (iv) Other dialysis facilities. (v) Volunteers. (2) Contact information for the following: (i) Federal, State, trib al, regional or local emer gency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means fo r communicating with the following: (i) Dialysis facility’s staff. (ii) Federal, State, trib al, regional, or local emerge ncy management agencies. (4) A method for sharing information and me dical documentation for patients under the dialysis facility’s care, as necessa ry, with other health care providers to ensure continuity of care. (5) A means, in the event of an evacuati on, to release patient information as permitted

under 45 CFR 164.510. (6) A means of providing information a bout the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). (7) A means of providing information about the dialysis facility’s need s, and its ability to provide assistance, to the aut hority having jurisdiction or th e Incident Command Center, or designee.441

(d) Training, testing, and orientation

. The dialysis facility mu st develop and maintain an emergency preparedness training, te sting and patient orientation pr ogram that must be evaluated and updated at least annually. (1) Training program . The dialysis facility must do all of the following: (i) Initial training in emer gency preparedness policies and procedures to all new and existing staff, individuals provi ding services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency prep aredness training at least a nnually. Staff training must: (A) Ensure that staff can demonstrate know ledge of emergency procedures, including informing patients of-- ( 1 ) What to do; ( 2 ) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; ( 3 ) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must incl ude an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has th e ability to forward calls to a working phone number under such emergency conditions); and ( 4 ) How to disconnect themselves from the dialysis machine if an emergency occurs. (B) Ensure that, at a minimum, patient care staff maintain current CPR certification; and (C) Ensure that nursing sta ff are properly trained in the use of emergency equipment and emergency drugs. (D) Maintain documentation of the training.442

(2) Testing . The dialysis facility must conduct dril ls and exercises to test the emergency plan. The dialysis facility must: (i) Participate in a community mock disast er drill at least annually. If a community

mock disaster drill is no t available, conduct an in dividual, facility-based mock disaster drill at least annually. (ii) If the dialysis facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the dial ysis facility is exempt from engaging in a community or individual, facility-based mock disa ster drill for 1 year following the onset of the

actual event. (iii) Conduct a paper-based, tabl etop exercise at least annuall y. A tabletop exercise is a group discussion led by a facilitato r, using a narrated, clinically -relevant emergency scenario, and a set of problem statements, directed message s, or prepared questions designed to challenge an emergency plan. (iv) Analyze the dialysis f acility’s response to and mainta in documentation of all drills, tabletop exercises, and emergency events, and revise the dialysis facility’s emergency plan, as

needed. (3) Patient orientation . Emergency preparedness patien t training. The facility must provide appropriate orientation and training to patients, incl uding the areas specified in paragraph (d)(1) of this section.CMS-3178-P

(Catalog of Federal Domestic Assistance Prog ram No. 93.778, Medical Assistance Program; No. 93.773, Medicare—Hospital Insurance; and Pr ogram No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: February 28, 2013

______________________________ Marilyn Tavenner,

Administrator , Centers for Medicare & Medicaid Services

.

Dated: December 12, 2013

___________________________ Kathleen Sebelius, Secretary , Department of Health and Human Services

.

BILLING CODE 4120-01-P444

NOTE: The following appendix will not appe ar in the Code of Federal Regulations APPENDIX--Emergency Preparedne ss Resource Documents and Sites

Presidential Directives:

• Homeland Security Presidential Direct ive (HSPD-5): “Management of Domestic

Incidents ” authorized the Department of Homeland Security to develop and administer the National Incident Management Syst em (NIMS). NIMS consists of federal, state, local, tribal governments, private-sector and nongovernmental or ganizations to work together to prevent, respond to and recover from domestic inci dents. The directive can be found at http://www.gpo.gov/fdsys/pkg/PPP- 2003-book1/pdf/PPP-2003-book1-doc-pg229.pdf

• The elements of NIMS can be found at http://www.fema.gov/emergency/nims/index.shtm

• The National Response Framework (NRF) is a guide to how the nation should conduct all-hazards responses. Further information can be found at http://www.fema.gov/NRF

• The National Strategy for Pandemic In fluenza and Implementation Plan is a comprehensive approach to addressing the thr eat of pandemic influenza and can be found at http://www.flu.gov/professional/fed eral/pandemic-influenza.pdf

• The World Health Organi zation (WHO) maintains a rela tively up-to-date human case count of reported cases and death related to pand emic influenzas. The document can be found at http://www.who.int/csr/disease/av ian_influenza/country/en/index.html

• The National Strategy for Pandemic Influen za Implementation Plan was established to ensure that the Federal government’s efforts a nd resources would occur in a coordinated manner, the Federal government’s response, international efforts, transportation and borders, protecting human and animal health, law enforcement, public safety, and security, protection of personnel445

and insurance of continuity of operations. This document can be found at http://www.fao.org/docs/eims/uploa d/221561/national_plan_ai_usa_en.pdf

• Homeland Security Presid ential Directive (HSPD-21) addresses public health and medical preparedness. It es tablishes a National Strategy fo r Public Health and Medical Preparedness. The key principles are: prepared ness for all potential cata strophic health events,

vertical and horizontal coordina tion across levels of government, regional approach to health preparedness, engagement of the private sect or, academia and other non-governmental entities, and the roles of individual families and communities. It discusses integrated biosurveillance capability, countermeasure stockp iling and rapid distribution of medical countermeasures, mass casualty care in coordinating exis ting resources, and community re silience with oversight of this effort led by ASPR. The directive can be found at http://www.dhs.gov/xabout/laws/gc_1219263961449.shtm

• “National Preparedness Guid elines” adopt an all-hazards and risk-based approach to preparedness. It provides a set of national pla nning scenarios that represent a range of threats

that warrant national attention. For furthe r information, this document can be found at http://www.dhs.gov/xlibrary/assets/Na tional_Preparedness_Guidelines.pdf

• Presidential Directive ( PPD-8): National Preparedness . It is aimed at facilitating an integrated, all-of-nation, flexible , capabilities-based approach to preparedness. It requires the development of a National Preparedness Goal, a national system description, a national planning system that features the 5 integrated nationa l planning frameworks for prevention, protection, response, recovery and mitigation and federal interagency operational plans (FIOPS). This

directive can be found at http://www.dhs.gov/presidential-p olicy-directive-8-nationalpreparedness and at http://www.phe.gov/Preparedness/le gal/policies/Pages/ppd8.aspx446

Office of Inspector General (OIG), G overnment Accountability Office (GAO) and additional reports and their recommendations:

• OIG study entitled, “Nursing Home Emer gency Preparedness and Responses During Recent Hurricanes” (OEI-06-06-00020) conducted in re sponse to a request from the U. S. Senate Special Committee on Aging asking for an examination of nursing home emergency preparedness. Based on the study, the OIG had tw o recommendations for CMS: (1) strengthen

federal certification standards for nursi ng home emergency plans; and (2) encourage

communication and collaboration between State a nd local emergency enti ties and nursing homes. As a result of the OIG’s recommendations, the Secretary initiated an emergency preparedness improvement effort coordinated across all HHS agencies. This study can be found at http://oig.hhs.gov/oei/ reports/oei-06-06-00020.pdf

• The National Hurricane Center report en titled, “Tropical Cyclone Report, Hurricane Katrina, 23-30 August 2005” provided data on th e effect that the 2005 hurricanes had on the community. This report can be found at http://www.nhc.noaa.gov/pdf/TCRAL122005_Katrina.pdf

• GAO report entitled, “Disas ter Preparedness: Prelim inary Observations on the Evacuation of Hospitals and Nursing Homes Du e to Hurricanes” (GAO-06-443R) discusses the GAO’s findings regarding (1) res ponsibility for the decision to evacuate hospitals and nursing homes; (2) issues administrators consider wh en deciding to evacuate hospitals and nursing homes; and (3) the federal res ponse capabilities that support ev acuation of hospitals and nursing

homes. This can be found at http://www.gao.gov/new.items/d06443r.pdf

• GAO report entitled, “Disas ter Preparedness: Limitati ons in Federal Evacuation

Assistance for Health Faciliti es Should be Addressed” (GAO- 06-826) supports the findings447

noted in the first GAO report. In addition, th e GAO noted that the evacuation issues that facilities faced during and after the hurricanes occurred due to their inability to secure transportation when needed. This report can be found at www.gao.gov/cgi-bin/ getrpt?GAO-06-

826.

• GAO report, an after-event analysis, entitl ed, “Hurricane Katrina: Status of Hospital Inpatient and Emergency Departments in the Greater New Orleans Area” (GAO-06-1003) revealed that: (1) emergency departments were experiencing overcrowding and (2) the number of staffed inpatient beds per 1,000 population was greater than th at of the national average and expected to increase further and the number of staffed inpatient beds was not available in psychiatric care settings. While this study focused specifically on patient care issues in the New Orleans area, the same issues are common to ho spitals in any major metropolitan area. This report can be found at http://www.gao.gov/docdblite/de tails.php?rptno=GAO-06-1003

• GAO report, an after-event analysis entitl ed, “Disaster Recovery: Past Experiences Offer Recovery Lessons for Hurricane Ike and Gustav and Future Disasters” (GAO-09-437T) concluded that recovery from majo r disasters involves the combined efforts of federal, state and local governments. This report can be found at http://www.gao.gov/products/GAO-09-437T

• OIG study entitled, “Gaps Continue to Exist in Nursing Home Emergency Preparedness and Response Du ring Disasters: 2007-2010, OEI- 06-09-00270. The report noted 6 areas of concern that nursing hom es did not include in their pl ans but could affect residents during an emergency which are: staffing, resident care, resident identif ication, information and tracking, sheltering in pla ce, evacuation and communication and collaboration. GAO Recommendations for Response to Influenza Pandemics :448

• GAO report entitled, “Influenza Pandemi c: Gaps in Pandemic Planning and Preparedness Need to be Addressed” (GAO- 09-909T July 29,2009 expressed concern that many gaps in pandemic planning and preparedness still existed in the presen ce of a potential pandemic

influenza outbreak. This report can be located at http://www.gao.gov/new.items/d09909t.pdf

• GAO report entitled, “Influenza Pandemic: Monitoring and Assessing the Status of the National Pandemic Implementation Plan Needs Improvement” (GAO-10-73). The GAO assessed the progress of the res ponsible federal agenci es in implementing the plans 342 action items set forth in the “National Strategy for Pa ndemic Influenza: Implementation Plan. These reports can be found at http://www.gao.gov/new.items/d1073.pdf and http://georgewbushwhitehouse.archives.gov/homeland/pande mic-influenza-implementation.htm

. Resources for Healthcare Providers and Supplie rs for Responding to Pandemic Influenza:

• “One-step access to U. S. Government h1N1, Avian, and Pandemic Flu Information” website provides links to influenza guidance and in formation from federal agencies. This can be

found at www.flu.gov More information can be found at http://www.flu.gov/professional/index.html that provides information for hospitals, long term care facilities, outpatient facili ties, home health agencies, ot her health care providers and

clinicians.

• “HHS Pandemic Influenza Plan Supplem ent 3: Healthcare Planning” provides planning guidance for the provision of care in hospitals. This can be located at http://www.hhs.gov/pandemicflu/plan/sup3.html

• “Best Practices in Preparing for Pandemi c Influenza: A Primer for Governors and Senior State Officials (2006) written by the National Govern ors Association (NGA) provides449

both current and historical perspective on poten tial disease outbreaks in communities. This report can be found at http://www.nga.org/Files/ pdf/0607PANDEMICPRIMER.PDF

• The Public Readiness and Preparedness Act of 2005 establishes liability protections for program planners and qualified persons who prescr ibe, administer, or di spense covered counter

measures in the event of a credible risk of a future public health emergency. Additional

information can be found at: https://www.phe.gov/preparedness/le gal/prepact/pages/default.aspx Public Health Emergency Preparedness:

• HRSA Policy Informati on notice entitled, “Health Cent er Emergency Management Program Expectations” (Document No. 2007-15 dated August 22, 2007, can be found at http://www.hsdl.org/?view&did=478559 describes the declaration of a state of emergency at a local, state, regional, or nationa l level by an authorized public o fficial such as a governor, the Secretary of the Department of Health and Human Services or the President of the United States.

• CDC report describes natural disasters and man-made disaster s. To access this list, go

to http://emergency.cdc.gov/disasters/ under “emergency preparedne ss and response” and click on “specific hazards”.

• RAND Corporation 2006 repor t stated that sin ce 2001, the challenge has been the need to define public health emergency preparedne ss and the key elements that characterize a wellprepared community. This report can be found at http://www.rand.org/publica tions/randreview/issues /summer2006/pubhealth.html The RAND Corporation convene d a diverse panel of expert s to propose a public health emergency preparedness definiti on. According to this expert panel, in an article by Nelson, Lurie, Wasserman and Zakowski, titled “C onceptualizing and Defining Public Health Emergency Preparedness”, published in the Americ an Journal of Public Health, Supplement 1,450

2007, Volume 97, No S9-S11 defined public health emergency preparedness as the capability of the public health and health ca re systems, communities, and i ndividuals to prevent, protect against, quickly respond to and recover from hea lth emergencies. This report can be found at http://ajph.aphapublicat ions.org/doi/full/10

. 2105/AJPH.2007.114496

• Trust for America’s Health (TFAH) report published in December 2012 entitled, "Ready or Not? Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism". This report can be found at http://www.healthyame ricans.org/report/101/

.

• The HHS, 2011 Hospital Preparedness Program (HPP) report, entit led "From Hospitals to Healthcare Coalitions: Transforming Health Preparedness and Response in Our Communities", describes how the HPP has become a critical component of community resilience and enhancing the healthcare system's response cap abilities, preparedness measures, and best practices across the country. The report can be found at: http://www.phe.gov/Preparedness/planning/hpp /Documents/hpp-healthcare-coalitions.pdf

.

• A 2008 ASPR published document entitled, "Pandemic and All-Hazards Preparedness Act: Progress Report on the Implementation of Provisions Addressing At Risk Individuals," describes the activities undertaken since the pass age of the PAPHA to address needs of at-risk populations and describes some of the activities planned to work toward preparedness for at-risk populations. The report can be found at: http://www.phe.gov/Preparedness/legal/pah pa/Documents/pahpa-at-risk-report0901.pdf

.

• An August 30, 2005 article in the Health Affairs publication by Dausey, D., Lurie, N., and Diamond, A, entitled, "Public Health Respon se to Urgent Case Reports," evaluated the ability of local public health ag encies (LPHAs) to adequately m eet "a preparedness standard" set451

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 wee k. The goal of the test was to contact an "action officer" (that is, physician, nurse, epidemiologist, bioterrori sm coordinator, or infection control practitioner) responsible for responding to urgent case reports.

• A June 2004 article published by Lurie, N., Wasserman, J., Stoto, M., Myers, S., Namkung, P., Fielding, J., and Valdez, R. B., en titled, "Local Variations in Public Health Preparedness: Lessons from California", provid es information on performance measures that were developed based on identified essential pub lic health services. The article can be found at: http://content.healthaffairs.org/cgi/content/full/hlthaff.w4.341/DC1

. Development of Plans and Responses:

• Distributed nationally in FY 2012, ASPR’s publication (d istributed nationally in FY 2012), “Healthcare Preparedness Capabiliti es: National Guidance for Healthcare System Preparedness”, takes an innovative capability approach to assist state and territory grant awardee planning that focuses on a jurisdiction’s capacity to take a course of action. Additional

information can be found at: http://www.phe.gov/preparedness/res ponders/ndms/Pages/default.aspx

. A different ASFR guidance provides information, guidance and resources to support planners in preparing for mass casualty incidents and medical surges. The document includes a total of (8) healthcare preparedness capabilities that are: (1) healthcare syst em preparedness (for example. information regarding healthcare coalitions); (2) healthcare system recovery; (3) emergency operations coordination, (4) fatality management; (5 ) information sharing; (6) medical surge; (7) responder safety and health; and (8) volunteer management. This information can be found at: http://www.phe.gov/Preparedness/planning/ hpp/reports/Documen ts/capabilities.pdf

.452

• Center for Health Policy, Columbia University School of Nursing, policy paper, March 2008 entitled, "Adapting Standards of Ca re Under Extreme Conditions: Guidance for Professionals During Disasters, Pandemics, a nd Other Extreme Emergencies". This paper, aimed at the nursing population, di scusses the challenges to mee ting the usual standards of care during natural or man-made disa sters and makes recommendations for effectively providing care during emergency events. The paper can be found at: http://www.nursingworld.org/Ma inMenuCategories/H ealthcareandPolicyIssues/DPR/TheLawEth icsofDisasterResponse/Adap tingStandardsofCare.aspx

.

• Institute of Medicine (IOM) Septembe r 2009 report to the HHS entitled, "Guidelines for Establishing Crisis Standards of Care for Us e in Disaster Situations. The report provides guidance for State and local health agencies and h ealth care facilities rega rding the standards of care that should apply during di saster situations. This repor t covers guidance on conserving, substituting, adapting, and doing wi thout resources. Further information on this report can be

found at http://www.nap.edu/cata log.php?record_id=12749#

.

• CMS published two guidance documents dated September 30, 2007 and October 24, 2007. The first document entitled, "P rovider Survey and Certification Frequently Asked Questions: Declared Public Health Emer gencies – All Hazards, Health Standards and Quality Issues", answers questions for all providers and suppliers regarding the lessons that were learned during and after the 2005 hurricanes and can be found at: http://www.cms.hhs.gov/SurveyCertEme rgPrep/Downloads/AllHazardsFAQs.pdf . The second document entitled, “Survey and Certification Em ergency Preparedness In itiative: Provider Survey & Certification Declared Public Health Emergency FAQs – All Hazards," provides web address for emergency preparedness information. It provides links to va rious resources and to453

other federal emergency preparedne ss websites and can be found at: ( http://www.nhha.org/WhatsNewFiles/ S&C-08-01.01.AllHazardsFAQsmemo.pdf ). In addition, the website entitled, "Emergency Preparedne ss for Every Emergency," can be found at http://www.cms.HHS.gov/SurveyCertEmergPrep/

. Emergency Preparedness Related to People with Disabilities The National Council on Disability ’s website has a page entitled, “Emergency Management,” that can be found at http://www.ncd.gov/policy/ emergency_management. There are various reports/papers that contain specific inform ation on emergency planning for people with disabilities and on how important it is to include people with di sabilities in emergency planning, such as: • Effective Emergency Management: Making Improvements for Communities and People with Disabilities (2009) • The Impact of Hurricanes Katrina and Rita on People with Disabilities: A Look Back and Remaining Challenges (2006) • Saving Lives: Including People with Disabilities in Emer gency Planning (2005)

[FR Doc. 2013-30724 Filed 12/20/2013 at 4:15 pm; Publication Date: 12/27/2013]