DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Centers for Medicare & Medicaid Services 

42 CFR Parts 403, 416, 418, 441, 460, 482, 483, 484, 485, 486, 491, and 494 

[CMS-3178-P] 

RIN 0938-AO91 

Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare 

and Medicaid Participating Providers and Suppliers 

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule. 

SUMMARY: This proposed rule would establish national emergency preparedness 

requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that 

they adequately plan for both natural and man-made disasters, and coordinate with federal, state, 

tribal, regional, and local emergency preparedness systems. It would also ensure that these 

providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, 

and participants during disasters and emergency situations. 

 We are proposing emergency preparedness requirements that 17 provider and supplier 

types must meet to participate in the Medicare and Medicaid programs. Since existing Medicare 

and Medicaid requirements vary across the types of providers and suppliers, we are also 

proposing variations in these requirements. These variations are based on existing statutory and 

regulatory policies and differing needs of each provider or supplier type and the individuals to 

whom they provide health care services. Despite these variations, our proposed regulations 

would provide generally consistent emergency preparedness requirements, enhance patient safety 
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during emergencies for persons served by Medicare- and Medicaid-participating facilities, and 

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

DATES: To be assured consideration, comments must be received at one of the addresses 

provided below, no later than 5 p.m. on [OFR--insert date 60 days after date of publication in the

Federal Register]. 

ADDRESSES: In commenting, please refer to file code CMS-3178-P. Because of staff and 

resource limitations, we cannot accept comments by facsimile (FAX) transmission. 

 You may submit comments in one of four ways (please choose only one of the ways 

listed): 

1. Electronically. You may submit electronic comments on this regulation to 

http://www.regulations.gov. Follow the "Submit a comment" instructions. 

2. By regular mail. You may mail written comments to the following address ONLY: 

 Centers for Medicare & Medicaid Services, 

Department of Health and Human Services, 

Attention: CMS-3178-P, 

P.O. Box 8013, 

Baltimore, MD 21244-8013. 

Please allow sufficient time for mailed comments to be received before the close of the 

comment period. 

3. By express or overnight mail. You may send written comments to the following 

address ONLY: 

 Centers for Medicare & Medicaid Services, 

 Department of Health and Human Services, 
 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 prior to the close of the comment period: 

a. For delivery in Washington, DC-- 

Centers for Medicare & Medicaid Services, 

Department of Health and Human Services, 

Room 445-G, Hubert H. Humphrey Building, 

200 Independence Avenue, SW., 

Washington, DC 20201 

(Because access to the interior of the Hubert H. Humphrey Building is not readily 

available to persons without federal government identification, commenters are encouraged to 

leave their comments in the CMS drop slots located in the main lobby of the building. A stampin clock is available for persons wishing to retain a proof of filing by stamping in and retaining 

an extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD-- 

Centers for Medicare & Medicaid Services, 

Department of Health and Human Services, 

7500 Security Boulevard, 

Baltimore, MD 21244-1850. 

If you intend to deliver your comments to the Baltimore address, please call telephone 

number (410) 786-7195 in advance to schedule your arrival with one of our staff members. 
 4

Comments erroneously mailed to the addresses indicated as appropriate for hand or 

courier delivery may be delayed and received after the comment period. 

For information on viewing public comments, see the beginning of the 

"SUPPLEMENTARY INFORMATION" section. 

FOR FURTHER INFORMATION CONTACT: 

Janice Graham, (410) 786-8020. 

Mary Collins, (410) 786-3189. 

Diane Corning, (410) 786-8486. 

Ronisha Davis, (410) 786-6882. 

Lisa Parker, (410) 786-4665.

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All comments received before the close of the comment period 

are available for viewing by the public, including any personally identifiable or confidential 

business information that is included in a comment. We post all comments received before the 

close of the comment period on the following Web site as soon as possible after they have been 

received: http://www.regulations.gov. Follow the search instructions on that Web site to view 

public comments. 

 Comments received timely will also be available for public inspection as they are 

received, generally beginning approximately 3 weeks after publication of a document, at the 

headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To 

schedule an appointment to view public comments, phone 1-800-743-3951. 
 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 Commission for Health Care, Inc. 

ACHE American College of Healthcare Executives 

AHA American Hospital Association 

AO Accrediting Organization 

AOA American Osteopathic Association 

ASC Ambulatory Surgical Center 

ARCAH Accreditation Requirements for Critical Access Hospitals 

ASPR Assistant Secretary for Preparedness and Response 

BLS Bureau of Labor Statistics 

BTCDP Bioterrorism Training and Curriculum Development Program 

CAH Critical Access Hospital 

CAMCAH Comprehensive Accreditation Manual for Critical Access Hospitals 

CAMH Comprehensive Accreditation Manual for Hospitals 

CASPER Certification and the Survey Provider Enhanced Reporting 

CDC Centers for Disease Control and Prevention 

CFC Conditions for Coverage 

CHAP Community Health Accreditation Program 

CMHC Community Mental Health Center 

COI Collection of Information 
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COP Conditions of Participation 

CORF Comprehensive Outpatient Rehabilitation Facilities 

CPHP Centers for Public Health Preparedness 

CRI Cities Readiness Initiative 

DHS Department of Homeland Security 

DHHS Department of Health and Human Services 

DOL Department of Labor 

DPU Distinct Part Units 

DSA Donation Service Area 

EOP Emergency Operations Plans 

EC Environment of Care 

EMP Emergency Management Plan 

EP Emergency Preparedness 

ESF Emergency Support Function 

ESRD End-Stage Renal Disease 

FEMA Federal Emergency Management Agency 

FDA Food and Drug Administration 

FQHC Federally Qualified Health Clinic 

GAO Government Accountability Office 

HFAP Healthcare Facilities Accreditation Program

HHA Home Health Agencies 

HPP Hospital Preparedness Program 

HRSA Health Resources and Services Administration 

HSC Homeland Security Council 
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HSEEP Homeland Security Exercise and Evaluation Program 

HSPD Homeland Security Presidential Directive 

HVA Hazard Vulnerability Analysis 

ICFs/IID Intermediate Care Facilities for Individuals with Intellectual Disabilities 

ICR information Collection Requirements 

IDG Interdisciplinary Group 

IOM Institute of Medicine 

JCAHO Joint Commission on the Accreditation of Healthcare Organizations 

JPATS Joint Patient Assessment and Tracking System 

LD Leadership 

LPHA Local Public Health Agencies 

LSC Life Safety Code 

LTC Long Term Care 

MMRS Metropolitan Medical Response System 

MS Medical Staff 

NDMS National Disaster Medical System 

NF Nursing Facilities 

NFPA National Fire Protection Association 

NIMS National Incident Management System 

NIOSH National Institute for Occupational Safety and Health 

NLTN National Laboratory Training Network 

NRP National Response Plan 

NRF National Response Framework 
 8

NSS National Security Staff 

OBRA Omnibus Budget Reconciliation Act 

OIG Office of the Inspector General 

OPHPR Office of Public Health Preparedness and Response 

OPO Organ Procurement Organization 

OPT Outpatient Physical Therapy 

OPTN Organ Procurement and Transplantation Network 

OSHA Occupational Safety and Health Administration 

ORHP Office of Rural Health Policy 

PACE Program for the All-Inclusive Care for the Elderly 

PAHPA Pandemic and All-Hazards Preparedness Act 

PHEP Public Health Emergency Preparedness 

PIN Policy Information Notice 

PPD Presidential Policy Directive 

PRTF Psychiatric Residential Treatment Facilities 

QAPI Quality Assessment and Performance Improvement 

QIES Quality Improvement and Evaluation System 

RFA Regulatory Flexibility Act 

RNHCI Religious Nonmedical Health Care Institutions 

RHC Rural Health Clinic 

SAMHSA Substance Abuse and Mental Health Services Administration 

SLP Speech Language Pathology 

SNF Skilled Nursing Facility 
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SNS Strategic National Stockpile 

TEFRA Tax Equity and Fiscal Responsibility Act 

TFAH Trust for America's Health 

TJC The Joint Commission 

TTX Tabletop Exercise 

UMRA Unfunded Mandates Reform Act 

UPMC University of Pittsburgh Medical Center 

WHO World Health Organization 

Table of Contents 

I. Overview 

A. Executive Summary 

1. Purpose 

2. Summary of the Major Provisions 

B. Current State of Emergency Preparedness 

1. Federal Emergency Preparedness 

2. State and Local Emergency Preparedness 

3. Hospital Preparedness 

4. GAO and OIG Reports 

C. Statutory and Regulatory Background 

 II. Provisions of the Proposed Regulation 

 A. Emergency Preparedness Regulations for Hospitals (§ 482.15) 

 1. Emergency plan 

 a. Emergency Planning Resources 
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b. Risk Assessment 

c. Patient Population and Available Services 

d. Succession Planning and Cooperative Efforts 

 2. Policies and procedures 

 3. Communication plan 

 4. Training and testing 

 B. Emergency Preparedness Regulations for Religious Nonmedical Health Care 

Institutions (RNHCIs) (§ 403.748) 

 C. Emergency Preparedness Regulations for Ambulatory Surgical Centers (ASCs) 

(§ 416.54) 

 D. Emergency Preparedness Regulations for Hospice (§ 418.113) 

 E. Emergency Preparedness Regulations for Inpatient Psychiatric Residential Treatment 

Facilities (PRTFs) (§ 441.184) 

 F. Emergency Preparedness Regulations for Programs of All-Inclusive Care for the 

Elderly (PACE) (§ 460.84) 

 G. Emergency Preparedness Regulations for Transplant Centers (§ 482.78) 

 H. Emergency Preparedness Regulations for Long-Term Care (LTC) Facilities 

(§ 483.73) 

 I. Emergency Preparedness Regulations for Intermediate Care Facilities for Individuals 

with Intellectual Disabilities (ICF/IID) (§ 483.475) 

 J. Emergency Preparedness Regulations for Home Health Agencies (HHAs) (§ 484.22) 

 K. Emergency Preparedness Regulations for Comprehensive Outpatient Rehabilitation 

Facilities (CORFs) (§ 485.68) 
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 L. Emergency Preparedness Regulations for Critical Access Hospitals (CAHs) 

(§ 485.625) 

 M. Emergency Preparedness Regulations for Clinics, Rehabilitation Agencies, and 

Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language 

Pathology Services (§ 485.727) 

 N. Emergency Preparedness Regulations for Community Mental Health Centers 

(CMHCs) (§ 485.920) 

 O. Emergency Preparedness Regulations for Organ Procurement Organizations (OPOs) 

(§ 486.360) 

 P. Emergency Preparedness Regulations for Rural Health Clinics (RHCs) and Federally 

Qualified Health Centers (FQHCs) (§ 491.12) 

 Q. Emergency Preparedness Regulations for End-Stage Renal Disease (ESRD) Facilities 

(§ 494.62) 

III. Collection of Information 

 A. Factors Influencing ICR Burden Estimates 

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

 C. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 403.748) 

D. ICRs Regarding Condition for Coverage: Emergency Preparedness (§ 416.54) 

E. ICRs Regarding Condition of Participation: Emergency Preparedness (§418.113) 

F. ICRs Regarding Emergency Preparedness (§441.184) 

G. ICRs Regarding Emergency Preparedness (§460.84) 

H. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 482.15) 
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I. ICRs Regarding Condition of Participation: Emergency Preparedness for Transplant 

Centers (§ 482.78) 

J. ICRs Regarding Emergency Preparedness (§ 483.73) 

K. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 483.475) 

L. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 484.22) 

M. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 485.68) 

N. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 485.625) 

O. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 485.727) 

P. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 485.920) 

Q. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 486.360) 

R. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 491.12) 

S. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 494.62) 

T. Summary of Information Collection Burden 

IV. Regulatory Impact Analysis (RIA) 

A. Statement of Need 

B. Overall Impact 

C. Anticipated Effects on Providers and Suppliers: General Provisions 

D. Condition of Participation: Emergency Preparedness for Religious Nonmedical 

Health Care Institutions (RNHCIs) 

E. Condition for Coverage: Emergency Preparedness for Ambulatory Surgical Centers 

(ASCs) --Testing (§ 416.54(d)(2)) 

F. Condition of Participation: Emergency Preparedness for Hospices--Testing 

(§ 418.113(d)(2)) 
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G. Emergency Preparedness for Psychiatric Residential Treatment Facilities (PRTFs) 

Training and Testing (§ 441.184(d)) 

H. Emergency Preparedness for Program for the All-Inclusive Care for the Elderly 

(PACE) Organizations--Training and Testing (§ 460.84(d)) 

I. Condition of Participation: Emergency Preparedness for Hospitals 

J. Condition of Participation: Emergency Preparedness for Transplant Centers 

K. Emergency Preparedness for Long Term Care (LTC) Facilities 

L. Condition of Participation: Emergency Preparedness for Intermediate Care Facilities 

for Individuals with Intellectual Disabilities (ICFs/IID) 

M. Condition of Participation: Emergency Preparedness for Home Health Agencies 

(HHAs) 

N. Conditions of Participation: Comprehensive Outpatient Rehabilitation Facilities 

(CORFs)-- (§ 485.68(d)(2)(i) through (iii)) 

O. Condition of Participation: Emergency Preparedness for Critical Access Hospitals 

(CAHs)--Testing (§ 485.625(d)(2)) 

P. Condition of Participation: Emergency Preparedness for Clinics, Rehabilitation 

Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and 

Speech-Language Pathology ("Organizations")--Testing (§ 485.727(d)(2)(i) through (iii)) 

Q. Condition of Participation: Emergency Preparedness for Community Mental Health 

Centers (CMHCs)--Training and Testing (§ 485.920(d)) 

R. Conditions of Participation: Emergency Preparedness for Organ Procurement 

Organizations (OPOs)--Training and Testing (§ 486.360(d)(2)(i) through (iii)) 
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S. Emergency Preparedness: Conditions for Certification for Rural Health Clinics 

(RHCs) and Conditions for Coverage for Federally Qualified Health Clinics (FQHCs) 

T. Condition of Participation: Emergency Preparedness for End-Stage Renal Disease 

Facilities (Dialysis Facilities)--Testing (§ 494.62(d)(2)(i) through (iv))

U. Summary of the Total Costs 

V. Benefits of the Proposed Rule 

 W. Alternatives Considered 

 X. Accounting Statement 

Appendix--Emergency Preparedness Resource Documents and Sites 

I. Overview 

A. Executive Summary

1. Purpose 

Over the past several years, the United States has been challenged by several natural and 

man-made disasters. As a result of the September 11, 2001 terrorist attacks, the subsequent 

anthrax attacks, the catastrophic hurricanes in the Gulf Coast states in 2005, flooding in the 

Midwestern states in 2008, tornadoes and floods in the spring of 2011, the 2009 H1N1 influenza 

pandemic, and Hurricane Sandy in 2012, readiness for public health emergencies has been put on 

the national agenda. For the purpose of this proposed regulation, "emergency" or "disaster" can 

be defined as an event affecting the overall target population or the community at large that 

precipitates the declaration of a state of emergency at a local, state, regional, or national level by 

an authorized public official such as a governor, the Secretary of the Department of Health and 

Human Services (HHS), or the President of the United States. (See Health Resources and 

Services Administration (HRSA) Policy Information notice entitled, "Health Center Emergency 
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Management Program Expectations," (Document No. 2007-15, dated August 22, 2007, found at 

http://www.hsdl.org/?view&did=478559). Disasters can disrupt the environment of health care 

and change the demand for health care services. This makes it essential that health care 

providers and suppliers ensure that emergency management is integrated into their daily 

functions and values. 

In preparing this proposed rule, we reviewed the guidance, developed by the Food and 

Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Health 

Resources and Services Administration (HRSA), and the Office of the Assistant Secretary for 

Preparedness and Response (ASPR). Additionally, we held regular meetings with these agencies 

and ASPR to collaborate on federal emergency preparedness requirements. To guide us in the 

development of this rule, we also reviewed several other sources to find the most current best 

practices in the health care industry. These sources included other federal agencies; The Joint 

Commission (TJC) standards for emergency preparedness; the American Osteopathic 

Association (AOA) standards for disaster preparedness (currently written for Critical Access 

Hospitals (CAHs) only); the National Fire Protection Association (NFPA) standards in NFPA 

101 Life Safety Code and NFPA 1600: "Standard on Disaster/Emergency Management and 

Business Continuity Programs," 2007 Edition; state-level requirements for some states, including 

those for California and Maryland; and policy guidance from the American College of 

Healthcare Executives (ACHE), entitled the "Healthcare Executives’ Role in Emergency 

Preparedness," which reinforces our position regarding the necessity of this proposed rule. Many 

of the resources we reviewed in the development of this proposed rule are listed in the 

APPENDIX—“Emergency Preparedness Resource Documents and Sites.” We encourage 
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providers and suppliers to use these resources to develop and maintain their emergency 

preparedness plans. 

We also reviewed existing Medicare emergency preparedness requirements for both 

providers and suppliers. We concluded that current emergency preparedness regulatory 

requirements are not comprehensive enough to address the complexities of actual emergencies. 

Specifically, the requirements do not address the need for: (1) communication to coordinate with 

other systems of care within local jurisdictions (for example. cities, counties) or states; (2) 

contingency planning; and (3) training of personnel. 

Based on our analysis of the written reports, articles, and studies, as well as on our 

ongoing dialogue with representatives from the federal, state, and local levels and with various 

stakeholders, we believe that, currently, in the event of a disaster, health care providers and 

suppliers across the nation would not have the necessary emergency planning and preparation in 

place to adequately protect the health and safety of their patients. Underlying this problem is the 

pressing need for a more consistent regulatory approach that would ensure that providers and 

suppliers nationwide are required to plan for and respond to emergencies and disasters that 

directly impact patients, residents, clients, participants, and their communities. As we have 

learned from past events and disasters, the current regulatory patchwork of federal, state, and 

local laws and guidelines, combined with the various accrediting organization emergency 

preparedness standards, falls far short of what is needed to require that health care providers and 

suppliers be adequately prepared for a disaster. Thus, we are proposing these emergency 

preparedness requirements to establish a comprehensive, consistent, flexible, and dynamic 

regulatory approach to emergency preparedness and response that incorporates the lessons 

learned from the past, combined with the proven best practices of the present. We recognize that 
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central to this approach is to develop and guide emergency preparedness and response within the 

framework of our national health care system. To this end, these proposed regulations would 

also encourage providers and suppliers to coordinate their preparedness efforts within their own 

communities and states as well as across state lines, as necessary to achieve their goals. We are 

soliciting comments on whether certain requirements should be implemented on a staggered 

basis. 

2. Summary of the Major Provisions 

We are proposing emergency preparedness requirements that will be consistent and 

enforceable for all affected Medicare and Medicaid providers and suppliers. This proposed rule 

addresses the three key essentials needed to ensure that health care is available during 

emergencies: safeguarding human resources, ensuring business continuity, and protecting 

physical resources. Current regulations for Medicare and Medicaid providers and suppliers do 

not adequately address these key elements. 

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

elements that are central to an effective and comprehensive framework of emergency 

preparedness requirements for the various Medicare and Medicaid participating providers and 

suppliers. The four elements of the emergency preparedness program are as follows: 

● Risk assessment and planning: This proposed rule would propose that prior to 

establishing an emergency plan, a risk assessment would be performed based on utilizing an 

“all-hazards” approach. An all-hazards approach is an integrated approach to emergency 

preparedness planning that focuses on capacities and capabilities that are critical to preparedness 

for a full spectrum of emergencies or disasters. This approach is specific to the location of the 
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provider and supplier considering the particular types of hazards which may most likely occur in 

their area. 

● Policies and procedures: We are proposing that facilities be required to develop and 

implement policies and procedures based on the emergency plan and risk assessment. 

● Communication plan: This proposed rule would require a facility to develop and 

maintain an emergency preparedness communication plan that complies with both federal and 

state law. Patient care must be well-coordinated within the facility, across health care providers, 

and with state and local public health departments and emergency systems to protect patient 

health and safety in the event of a disaster. 

● Training and testing: We are proposing that a facility develop and maintain an 

emergency preparedness training and testing program. A well-organized, effective training 

program must include providing initial training in emergency preparedness policies and 

procedures. We propose that the facility ensure that staff can demonstrate knowledge of 

emergency procedures and provide this training at least annually. We would require that 

facilities conduct drills and exercises to test the emergency plan. 

We are seeking public comments on when these CoPs should be implemented. 

B. Current State of Emergency Preparedness

1. Federal Emergency Preparedness 

In response to the September 11, 2001 terrorist attacks and the subsequent national need 

to refine the nation’s strategy to handle emergency situations, there have been numerous efforts 

across federal agencies to establish a foundation for development and expansion of emergency 

preparedness systems. The following is a brief overview of some emergency preparedness 
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activities at the federal level. Additional information is included in the appendix to this proposed 

rule. 

a. Presidential Directives 

Three Presidential Directives HSPD-5, HSPD-21 and PPD-8, require agencies to 

coordinate their emergency preparedness activities with each other and across federal, state, 

local, tribal, and territorial governments. Although these directives do not specifically require 

Medicare providers and suppliers to adopt such measures, they have set the stage for what we 

expect from our providers and suppliers in regard to their roles in a more unified emergency 

preparedness system. The Homeland Security Presidential Directive (HSPD-5), "Management 

of Domestic Incidents," was issued on February 28, 2003. This directive authorizes the 

Department of Homeland Security to develop and administer the National Incident Management 

System (NIMS). The NIMS provides a consistent national template that enables federal, state, 

local, and tribal governments, as well as private-sector and nongovernmental organizations, to 

work together effectively and efficiently to prepare for, prevent, respond to, and recover from 

domestic incidents, regardless of cause, size, or complexity, including acts of catastrophic 

terrorism. The Presidential Policy Directive (PPD-8 focuses on strengthening the security and 

resilience of the nation through systematic preparation for the full range of 21st century hazards 

that threaten the security of the nation, including acts of terrorism, cyber attacks, pandemics, and 

catastrophic natural disasters. The directive is founded by 3 key principles which include: (1) 

employ an all-of-nation/whole community approach, integrate efforts across federal, state, local, 

tribal and territorial governments; (2) build key capabilities to confront any challenge; and (3) 

utilize an assessment system focused on outcomes to measure and track progress. Finally, the 

Presidential directive published on October 18, 2007, entitled, "Homeland Security Presidential 
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Directive/HSPD-21," addresses public health and medical preparedness. The directive, found at 

http://www.dhs.gov/xabout/laws/gc_1219263961449.shtm, establishes a National Strategy for 

Public Health and Medical Preparedness (Strategy), which aims to transform our national 

approach to protecting the health of the American people against all disasters. HSPD-21 

summarizes implementation actions that are the four most critical components of public health 

and medical preparedness: biosurveillance, countermeasure stockpiling and distribution, mass 

casualty care, and community resilience. The directive states that these components will receive 

the highest priority in public health and medical preparedness efforts. 

b. Assistant Secretary for Preparedness and Response 

In December 2006, the President signed the Pandemic and All-Hazards Preparedness Act 

(PAHPA) (Pub. L. 109-417). The purpose of the Pandemic and All-Hazards Preparedness Act is 

“to improve the Nation’s public health and medical preparedness and response capabilities for 

emergencies, whether deliberate, accidental, or natural.” The Office of the Assistant Secretary 

for Preparedness and Response (ASPR) was created under the PAHPA Act in the wake of 

Katrina to lead the nation in preventing, preparing for, and responding to the adverse health 

effects of public health emergencies and disasters. The Secretary of HHS delegates to ASPR the 

leadership role for all health and medical services support functions in a health emergency or 

public health event. ASPR also serves as the senior advisor to the HHS Secretary on public 

health and medical preparedness and provides, at a minimum, support for; building federal 

emergency medical operational response and recovery capabilities; countermeasures research, 

advance development, and procurement; and grants to strengthen the capabilities of healthcare 

preparedness at the state, regional, local and healthcare coalition levels for public health 

emergencies and medical disasters. The office provides federal support, including medical 
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professionals through ASPR’s National Disaster Medical System (NDMS), to augment state and 

local capabilities during an emergency or disaster. The purpose of the NDMS is to establish a 

single, integrated, and national medical response capability to assist state and local authorities in 

dealing with the medical impacts of major peacetime disasters and to provide support to the 

military and the Department of Veterans Affairs medical systems in caring for casualties 

evacuated back to the U.S. from overseas conflicts. The NDMS, as part of the HHS, led by 

ASPR, supports federal agencies in the management and coordination of the federal medical 

response to major emergencies and federally declared disasters including natural disasters, 

technological disasters, major transportation accidents, and acts of terrorism, including weapons 

of mass destruction events. Additional information can be found at: 

http://www.phe.gov/preparedness/responders/ndms/Pages/default.aspx. 

ASPR also administers the Hospital Preparedness Program (HPP), which provides 

leadership and funding through grants and cooperative agreements to states, territories, and 

eligible municipalities to improve surge capacity and enhance community and hospital 

preparedness for public health emergencies. Through the work of its state partners, HPP has 

advanced the preparedness of hospitals and communities in numerous ways, including building 

healthcare coalitions, planning for all hazards, increasing surge capacity, tracking the availability 

of beds and other resources using electronic systems, and developing communication systems 

that are interoperable with other response partners. 

The first response in a disaster is always local, and comprised of local government 

emergency services supplemented by state and volunteer organizations. This aspect of the 

“disaster response” is specifically coordinated by state and local authorities. When an incident 

overwhelms or is anticipated to overwhelm state resources, the Governor of a state or chief 
 22

executive of a tribe may request federal assistance. In such cases, the affected local jurisdiction, 

tribe, state, and the federal government will collaborate to provide that necessary assistance. 

When it is clear that state capabilities will be exceeded, the Governor or the tribal executive can 

request federal assistance, including assistance under the Robert Stafford Disaster Relief and 

Emergency Assistance Act (Stafford Act). The Stafford Act authorizes the President to provide 

financial and other assistance to state and local governments, certain private nonprofit 

organizations, and individuals to support response, recovery, and mitigation efforts following 

Presidential emergency or major disaster declarations. 

The National Response Framework (NRF), a guide to how the nation should conduct all 

hazards responses, includes 15 Emergency Support Functions (ESFs), which are groupings of 

governmental and certain private sector capabilities into an organizational structure. The 

purpose of the ESFs is to provide support, resources, program implementation, and services that 

are most likely needed to save lives, protect property and the environment, restore essential 

services and critical infrastructure, and help victims and communities return to normal following 

domestic incidents. HHS is the primary agency responsible for ESF 8- Public Health and 

Medical Services. 

The Secretary of HHS leads all federal public health and medical response to public 

health and medical emergencies and incidents that are covered by the Stafford Act, via NRF, or 

the Public Health Service Act. Under the NRF, ESF 8 is coordinated by the Secretary of HHS 

principally through the Assistant Secretary for Preparedness and Response (ASPR). ESF 8 – 

Public Health and Medical Services provides the mechanism for coordinated federal assistance to 

supplement state, tribal, and local jurisdictional resources in response to a public health and 
 23

medical disaster, potential or actual incidents requiring a coordinated federal response, or during 

a developing potential health and medical emergency. 

c. Centers for Disease Control and Prevention 

The Centers for Disease Control and Prevention (CDC) Office of Public Health 

Preparedness and Response (OPHPR) leads the agency's preparedness and response activities by 

providing strategic direction, support, and coordination for activities across CDC as well as with 

local, state, tribal, national, territorial, and international public health partners. CDC provides 

funding and technical assistance to states to build and strengthen public health capabilities. 

Ensuring that states can adequately respond to threats will result in greater health security; a 

critical component of overall U.S. national security. Additional information can be found at: 

http://www.cdc.gov/phpr/. The CDC Public Health Emergency Preparedness (PHEP) 

cooperative agreement, led by OPHPR, is a critical source of funding for state, local, tribal, and 

territorial public health departments. Since 2002, the PHEP cooperative agreement has provided 

nearly $9 billion to public health departments across the nation to upgrade their ability to 

effectively respond to a range of public health threats, including infectious diseases, natural 

disasters, and biological, chemical, nuclear, and radiological events. Preparedness activities 

funded by the PHEP cooperative agreement are targeted specifically for the development of 

emergency-ready public health departments that are flexible and adaptable. The Strategic 

National Stockpile (SNS), administered by the CDC, is a stockpile of pharmaceuticals and 

medical supplies. The SNS program was created to assist states and local communities in 

responding to public health emergencies, including those resulting from terrorist attacks and 

natural disasters. The SNS program ensures the availability of necessary medicines, antidotes, 

medical supplies, and medical equipment for states and local communities, to counter the effects 
 24

of biological pathogens and chemical and nerve agents. 

(http://www.cdc.gov/phpr/stockpile/stockpile.htm). 

The Cities Readiness Initiative (CRI), led by CDC, is a federally funded pilot program to 

help cities increase their capacity to deliver medicines and medical supplies within 48 hours after 

recognition of a large-scale public health emergency such as a bioterrorism attack or a nuclear 

accident. More information on this effort can be found at: http://www.bt.cdc.gov/cri/. An 

evaluative report of this program since its inception, requested by the CDC, performed by the 

RAND Corporation, and published in 2009, entitled, "Initial Evaluation of the Cities Readiness 

Initiative" can be found at http://www.rand.org/pubs/technical_reports/2009/RAND_TR640.pdf. 

Given the heightened concern regarding the impact of various influenza outbreaks in 

recent years, the federal government has created a 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 guidance and information from federal agencies, such as the CDC, as 

well as checklists for pandemic preparedness. The information and links are found at 

http://www.flu.gov/professional/index.html. This website includes information for hospitals, 

long term care facilities, outpatient facilities, home health agencies, other health care providers, 

and clinicians. For example, the "Hospital Pandemic Influenza Planning Checklist" provides 

guidance on structure for planning and decision making; development of a written pandemic 

influenza plan; and elements of an influenza pandemic plan. The checklist is comprehensive and 

lists everything a hospital should do to prepare for a pandemic, from planning for coordination 

with local and regional planning and response groups to infection control. 
 25

2. State and Local Preparedness 

A review of studies and articles regarding readiness of state and local jurisdictions 

reveals that there is inconsistency in the level of emergency preparedness amongst states and 

need for improvement in certain areas. In a report by the Trust for America’s Health (TFAH) 

(December 2012, http://www.healthyamericans.org/report/101/) entitled, "Ready or Not? 

Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism" the authors assessed 

state-by-state public health preparedness nearly 10 years after the September 11th and anthrax 

tragedies. Using 10 key indicators to rate levels of public health preparedness, some key 

findings included: (1) 29 states cut public health funding from fiscal years (FY) 2010 through 

2012, with 2 of these states cutting funds for a second year in a row and 14 for 3 consecutive 

years, and that federal funds for state and local preparedness have decreased by 38 percent from 

FY 2005 through 2012 and (2) 35 states and Washington 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., Lurie, N., and Diamond, A.) evaluated the ability 

of local public health agencies (LPHAs) to adequately meet "a preparedness standard" set by the 

CDC. The standard was for the LPHAs "to receive and respond to urgent case reports of 

communicable diseases 24 hours a day, 7 days a week." Using 18 metropolitan area LPHAs that 

were roughly evenly distributed by agency size, structure, and region of the country, the goal of 

the test was to contact an "action officer" (that is, physician, nurse, epidemiologist, bioterrorism 

coordinator, or infection control practitioner) responsible for responding to urgent case reports. 
 26

During a 4-month period of time, each LPHA was contacted several times and asked 

questions regarding triage procedures, what questions would be asked in the event of an urgent 

case being filed, next steps taken after receiving such a report, and who would be contacted. 

Although the LPHAs had a substantial role in community public health through prevention and 

treatment efforts, the authors found significant variation in performance and the systems in place 

to respond to such reports. 

We also reviewed an article published in June 2004 by Lurie, N., Wasserman, J., Stoto, 

M., Myers, S., Namkung, P., Fielding, J., and Valdez, R. B., entitled, "Local Variations in 

Public Health Preparedness: Lessons from California" found at 

http://content.healthaffairs.org/cgi/content/full/hlthaff.w4.341/DC1. The authors stated that 

"evidence–based measures to assess public health preparedness are lacking in California." Using 

an "expert-panel process," the researchers developed performance measures based on ten 

identified essential public health services. They performed site visits and tabletop exercises to 

evaluate preparedness across the state in geographic locations identified as urban, rural, and 

border status to detect and respond to a hypothetical smallpox outbreak based on the different 

measures of preparedness. Overall, the researchers found that there was a lack of consensus 

regarding what "emergency preparedness" encompassed and a wide variation in what various 

governmental agencies deemed to be adequate emergency preparedness "readiness" in 

California. They noted that gaps in the infrastructure were common. 

Throughout the jurisdictions investigated, there were similarities noted in the shortage of 

nurses, the number of essential workers nearing retirement age, and the lack of epidemiologists, 

lab personnel, and public health nurses to meet potential needs. Such gaps in personnel 

infrastructure were found in many jurisdictions. In some jurisdictions, there was incomplete 
 27

information regarding the demographics of persons who could be considered potentially 

vulnerable or part of an underserved population. 

In one situation, there was also great variability in the length of time it took to bring three 

suspicious cases to public health officers’ attention and for these officers to realize that these 

cases were related. There was great variation in the public health officers’ ability to rapidly alert 

the physician and hospital community of an outbreak. There was a lack of consensus regarding 

when to report a potential outbreak to the public. There also was wide variation in knowledge of 

public health legal authority, specifically, in regard to quarantine and its enforcement. We 

believe these findings to be typical of most states. 

3. Hospital Preparedness 

Hospitals are the focal points for health care in their respective communities; thus, it is 

essential that hospitals have the capacity to respond in a timely and appropriate manner in the 

event of a natural or man-made disaster. Additionally, since Medicare-participating hospitals are 

required to evaluate and stabilize every patient seen in the emergency department and to evaluate 

every inpatient at discharge to determine his or her needs and to arrange for post-discharge care 

as needed, hospitals are in the best position to coordinate emergency preparedness planning with 

other providers and suppliers in their communities. We would expect hospitals to be prepared to 

provide care to the greatest number of disaster victims for which they have the capacity, while 

meeting at least minimal obligations for care to all who are in need. 

In 2007, ASPR contracted with the Center for Biosecurity of the University of Pittsburgh 

Medical Center (UPMC) (the Center) to conduct an assessment of U.S. hospital preparedness 

and to develop recommendations for evaluating and improving future hospital preparedness 

efforts. The Center’s assessment, entitled "Hospitals Rising to the Challenge: The First Five 
 28

Years of the U.S. Hospital Preparedness Program and Priorities Going Forward" describes the 

most important components of preparedness for mass casualty response at the local and regional 

hospital and healthcare system levels. This evaluation report was based on extensive analyses of 

the published literature, government reports, and HPP program assessments, as well as on 

detailed conversations with 133 health officials and hospital professionals representing every 

state, the largest cities, and major territories of the U.S. 

The authors stated that major disasters can severely challenge the ability of healthcare 

systems to adequately care for large numbers of patients (surge capacity) or victims with unusual 

or highly specialized medical needs (surge capability) such as occurred with Hurricane Katrina. 

The authors further stated that addressing medical surge and medical system resilience requires 

implementing systems that can effectively manage medical and health responses, as well as 

developing and maintaining preparedness programs. There were numerous findings and 

conclusions in the 2007 report. The researchers found that since the start of the HPP in 2002, 

individual hospitals’ disaster preparedness has improved significantly. The report found that 

hospital senior leadership is actively supporting and participating in preparedness activities, and 

disaster coordinators within hospitals have given sustained attention to preparedness and 

response planning efforts. Hospital emergency operations plans (EOPs) have become more 

comprehensive and, in many locations, are coordinated with community emergency plans and 

local hazards. Disaster training has become more rigorous and standardized; hospitals have 

stockpiled emergency supplies and medicines; situational awareness and communications are 

improving; and exercises are more frequent and of higher quality. The researchers also found 

improved collaboration and networking among and between hospitals, public health departments, 
 29

and emergency management and response agencies. These coalitions are believed to represent 

the beginning of a coordinated community-wide approach to medical disaster response. 

However, ASPR Healthcare Preparedness Capabilities: National Guidance for Healthcare 

System Preparedness (2012) and CDC Public Health Preparedness Capabilities: National 

Standards for State and Local Planning (March 2011) notes numerous federal directives that 

recognize the need for a consistent approach to preparedness planning across the nation so as to 

ensure an effective response. The 2010 IOM report also notes that direction at the federal level 

is essential in order to ensure a coordinated, interoperable disaster response. (IOM Medical 

Surge Capacity. 2009 Forum on Medical and Public Health Preparedness for Catastrophic 

Events, 2010)” 

4. OIG and GAO Reports 

Since Katrina, several studies regarding the preparedness of health care providers have 

been published. In general, these reports and studies point to a need for improved requirements 

to ensure that providers and suppliers are adequately prepared to meet the needs of patients, 

residents, clients, and participants during disasters and emergency situations. 

In response to a request from the U.S. Senate Special Committee on Aging calling for an 

examination of nursing home emergency preparedness, the Office of the Inspector General 

(OIG) conducted a study during 2004 through 2005 entitled, "Nursing Home Emergency 

Preparedness and Responses During Recent Hurricanes," (OEI-06-06-00020) 

http://oig.hhs.gov/oei/reports/oei-06-06-00020.pdf). The OIG reviewed state survey data for 

emergency preparedness measures both for the nation in general and for the Gulf States 

(Alabama, Florida, Louisiana, Mississippi, and Texas). The study indicated that in 2004 through 

2005, 94 percent of nursing homes nationwide met the limited federal regulations for emergency 
 30

plans then in existence, while only 80 percent met the federal standards for emergency training. 

Similar compliance rates were noted in the Gulf states. However, the OIG found that nursing 

homes in the Gulf states experienced problems even though they were in compliance with federal 

interpretive guidelines. Further, they experienced problems whether they evacuated residents or 

sheltered them in place. The OIG listed the problems encountered by Gulf state nursing homes 

including, transportation contracts that were not honored; lengthy travel times for residents; 

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

facilities that were unavailable or that were inadequately prepared, provisioned, or staffed for the 

transfer of residents; and difficulty re-entering their own facilities. As further detailed in the 

OIG report, the main reasons for these problems were lack of effective planning; failure to 

properly execute emergency plans; failure to anticipate the specific problems encountered; and 

failure to adjust decisions and actions to specific situations. 

The OIG also found that some facility administrators deviated, many significantly, from 

their emergency plans or worked beyond the plans, either because the plans were not updated or 

plans did not include instructions for certain circumstances. The report goes on to note that 

many of the nursing home emergency preparedness plans did not consider the following factors: 

the need to evacuate residents to alternate sites as evidenced by a formal agreement with a host 

facility; criteria to determine whether to evacuate residents or shelter them in place; a means by 

which an individual resident’s care needs would be identified and met; and re-entry into the 

facility following an evacuation. 

Although some local communities were directly involved in the evacuation of their 

nursing home residents, other nursing homes received assistance with evacuation from resident 

and staff family members, parent corporations, and "sister facilities," according to the OIG 
 31

report. A few nursing homes reported that problems with state and local government 

coordination during the hurricanes contributed to the problems they encountered. 

Based on this study, the OIG had two recommendations for CMS: (1) strengthen federal 

certification standards for nursing home emergency plans by including requirements for specific 

elements of emergency planning; and (2) encourage communication and collaboration between 

state and local emergency entities and nursing homes. As a result of the OIG’s 

recommendations, the Secretary initiated an emergency preparedness improvement effort to be 

coordinated across all HHS agencies. Our development of this proposed rule is an important part 

of HHS-wide efforts to meet the Department’s overall emergency preparedness goals and 

objectives by directly addressing the OIG recommendations. In April 2012, the OIG issued a 

subsequent report entitled, “Gaps Continue to Exist in Nursing Home Emergency Preparedness 

and response During Disaters: 2007-2010,” (OEI-06-09-00270 http://oig.hhs.gov/oei/reports/oei06-09-00270.pdf). This report notes that many of the gaps in nursing home preparedness and 

response identified in the 2006 report still exist. 

We also reviewed several Government Accountability Office (GAO) reports on 

emergency preparedness. One such report is entitled, "Disaster Preparedness: Preliminary 

Observations on the Evacuation of Hospitals and Nursing Homes Due to Hurricanes" (GAO-06-

443R), was published on February 16, 2006, and can be found at 

http://www.gao.gov/new.items/d06443r.pdf). This report discusses the GAO’s findings 

regarding--(1) responsibility for the decision to evacuate hospitals and nursing homes; (2) the 

issues administrators consider when deciding to evacuate hospitals and nursing homes; and (3) 

the federal response capabilities that support evacuation of hospitals and nursing homes. 
 32

The GAO found that "hospital and nursing home administrators are often responsible for 

deciding whether to evacuate patients from their facilities due to disasters, including hurricanes 

or other natural disasters. State and local governments can order evacuations of the population 

or segments of the population during emergencies, but health care facilities may be exempt from 

these orders." The GAO found that hospitals and nursing home administrators evacuate only as 

a last resort and that these facilities’ emergency plans are designed primarily to shelter in place. 

The GAO also found that administrators considered the availability of adequate resources to 

shelter in place, the risks to patients in deciding when to evacuate, the availability of 

transportation to move patients, the availability of receiving facilities to accept patients, and the 

destruction of the facility’s or community’s infrastructure. 

The GAO noted that nursing home administrators also must consider the fact that nursing 

home residents cannot care for themselves and generally have no home and no place to live other 

than the nursing home. Therefore, in the event of an evacuation, nursing homes also need to 

consider the necessity of locating facilities that can accommodate their residents for a long 

period of time. 

A second report from the GAO about the hurricanes’ impact entitled, "Disaster 

Preparedness: Limitations in Federal Evacuation Assistance for Health Facilities Should be 

Addressed," (GAO-06-826) July, 2006, www.gao.gov/cgi-bin/getrpt?GAO-06-826), supports the 

findings noted in the first GAO report on the disasters. In addition, the GAO noted that the 

evacuation issues that facilities faced during and after the hurricanes occurred due to their 

inability to secure transportation when needed. Despite previously established contracts with 

transportation companies, demand for this assistance overwhelmed the supply of vehicles in the 

community. 
 33

A third report, an after-event analysis entitled, "Hurricane Katrina: Status of Hospital 

Inpatient and Emergency Departments in the Greater New Orleans Area," (GAO-06-1003) 

September 29, 2006, http://www.gao.gov/docdblite/details.php?rptno=GAO-06-1003) revealed 

that, as of April 2006: (1) emergency departments were experiencing overcrowding; but that (2) 

the number of staffed inpatient beds per 1,000 population was greater than that of the national 

average and expected to increase further. However, the study found that the number of staffed 

inpatient beds was not available in psychiatric care settings. In fact, some persons with mental 

health needs had to be transferred out of the area due to a lack of beds. Attracting and retaining 

nursing and support staff were two problems that were identified as hindering efforts to maintain 

an adequate supply of staffed beds for psychiatric patients. 

While this study focused specifically on patient care issues in the New Orleans area, the 

same issues are common to hospitals in any major metropolitan area. Given the vulnerability of 

persons with mental illness and the tremendous stress a man-made or natural disaster can put on 

the entire general population, an increase in the number of persons who seek mental health 

services and require inpatient psychiatric care can be expected following any natural or 

man-made disaster. 

In another report from the GAO, an after-event analysis entitled, "Disaster Recovery: 

Past Experiences Offer Recovery Lessons for Hurricane Ike and Gustav and Future Disasters," 

(GAO-09-437T March 3, 2009, http://www.gao.gov/products/GAO-09-437T) the GAO 

concluded that recovery from major disasters is a complex undertaking that involves the 

combined efforts of federal, state, and local government in order to succeed. The GAO stated 

that while the federal government provides a significant amount of financial and technical 
 34

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

secure and make use of those resources. 

In a report from the GAO, entitled, "Influenza Pandemic: Gaps in Pandemic Planning 

and Preparedness Need to be Addressed," (GAO-09-909T July 29, 2009; 

http://www.gao.gov/new.items/d09909t.pdf), the GAO expressed its concern that, despite a 

number of actions having been taken to plan for a pandemic, including developing a National 

Strategy and Implementation Plan, many gaps in pandemic planning and preparedness still 

existed in the presence of a potential pandemic influenza outbreak. 

In November 2009, the GAO published an additional report entitled, "Influenza 

Pandemic: Monitoring and Assessing the Status of the National Pandemic Implementation Plan 

Needs Improvement," (GAO-10-73) (http://www.gao.gov/new.items/d1073.pdf). In this report, 

the GAO assessed the progress of the responsible federal agencies (including HHS) in 

implementing the action items set forth in the "National Strategy for Pandemic Influenza: 

Implementation Plan" (the Plan) (http://georgewbushwhitehouse.archives.gov/homeland/pandemic-influenza-implementation.html). Specifically, the 

researchers were interested in determining how the Homeland Security Council (HSC) and the 

responsible federal agencies were monitoring the progress and completion of the Plan’s 342 

action items, and assessing the extent to which selected action items were completed, whether 

activity had continued on the selected action items reported as complete, and the nature of that 

work. Having conducted an in-depth analysis of a random sample of 60 action items, the GAO 

found the status of selected action items considered complete was difficult to determine. 

Specifically, the GAO found that: (1) measures of performance used to determine status did not 

always fully reflect the descriptions of the action items; (2) some selected action items were 
 35

designated as complete despite requiring actions outside the authority of the responsible entities; 

and (3) additional work was conducted on some selected action items designated as complete. 

Ultimately, the GAO recommended that, in order to improve how progress is monitored and 

completion is assessed under the Plan and subsequent updates of the Plan, the HSC should 

instruct the White House National Security Staff (NSS) to work with responsible federal 

agencies to: (1) develop a monitoring and reporting process for action items that are intended for 

nonfederal entities, such as state and local governments; (2) identify the types of information 

needed to decide whether to carry out the response-related action items; and (3) develop 

measures of performance that are more consistent with the descriptions of the action items. 

C. Statutory and Regulatory Background 

Various sections of the Social Security Act (the Act) define the terms Medicare uses for 

each provider and supplier type and list the requirements that each provider and supplier must 

meet to be eligible for Medicare and Medicaid participation. Each statutory provision also 

specifies that the Secretary may establish other requirements as the Secretary finds necessary in 

the interest of the health and safety of patients, although the exact wording of such authority may 

differ slightly between different provider and supplier types. These requirements are called the 

Conditions of Participation (CoPs) for providers and the Conditions for Coverage (CfCs) for 

suppliers. The CoPs and CfCs are intended to protect public health and safety and ensure that 

high quality care is provided to all persons. Further, the Public Health Service (PHS) Act sets 

forth additional requirements that certain Medicare providers and suppliers must meet to 

participate. 

The following are the statutory and regulatory citations for the providers and suppliers for 

which we intend to propose emergency preparedness regulations: 
 36

● Religious Nonmedical Health Care Institutions (RNHCIs) – section 1821 of the Act 

and 42 CFR 403.700 through 403.756. 

● Ambulatory Surgical Centers (ASCs) – section 1832(a)(2)(F)(i) of the Act and 42 CFR 

416.40 through 416.49.

● Hospices – section 1861(dd)(1) of the Act and 42 CFR 418.52 through 418.116.

● Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or 

Programs (PRTFs) – sections1905(a) and 1905(h) of the Act and 42 CFR 441.150 through 

441.182 and 42 CFR 483.350 through 483.376. 

● Programs of All-Inclusive Care for the Elderly (PACE) - sections 1894, 1905(a), and 

1934 of the Act and 42 CFR 460.2 through 460.210.

● Hospitals - section 1861(e)(9) of the Act and 42 CFR 482.1 through 482.66.

● Transplant Centers – sections 1861(e)(9) and 1881(b)(1) of the Act and 42 CFR 

482.68 through 482.104. 

● Long Term Care (LTC) Facilities –Skilled Nursing Facilities (SNFs) –under section 

1819 of the Act, Nursing Facilities (NFs) – under section 1919 of the Act, and 42 CFR 483.1 

through 483.180. 

● Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) - 

section 1905(d) of the Act and 42 CFR 483.400 through 483.480. 

● Home Health Agencies (HHAs) - sections 1861(o), 1891 of the Act and 42 CFR 484.1 

through 484.55. 

● Comprehensive Outpatient Rehabilitation Facilities (CORFs) - section 1861(cc)(2) of 

the Act and 42 CFR 485.50 through 485.74. 

● Critical Access Hospitals (CAHs) - sections 1820 and 1861(mm) of the Act and 42 
 37

CFR 485.601 through 485.647. 

● Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of 

Outpatient Physical Therapy and Speech-Language Pathology Services – section 1861(p) of the 

Act and 42 CFR 485.701 through 485.729. 

● Community Mental Health Centers (CMHCs) – section 1861(ff)(3)(B)(i)(ii) of the 

Act, section 1913(c)(1) of the PHS Act, and 42 CFR 410.110. 

● Organ Procurement Organizations (OPOs) - section 1138 of the Act and section 371 of 

the PHS Act and 42 CFR 486.301 through 486.348. 

● Rural Health Clinics (RHCs) - section 1861(aa) of the Act and 42 CFR 491.1 through 

491.11; Federally Qualified Health Centers (FQHCs) - section 1861(aa) of the Act and 42 CFR 

491.1 through 491.11, except 491.3. 

● End-Stage Renal Disease (ESRD) Facilities – sections 1881(b), 1881(c), 1881(f)(7) of 

the Act and 42 CFR 494.1 through 494.180. 

We considered proposing these regulations for each provider and supplier type 

individually, as we updated their CoPs or CfCs over time. However, for the reasons we have 

already discussed, we believe the most prudent course of action is to publish emergency 

preparedness requirements for Medicare and Medicaid providers and suppliers in a single 

proposed rule. Thus, we are proposing regulatory language for 17 Medicare and Medicaid 

providers and suppliers to address the four main aspects of emergency preparedness:--(1) risk 

assessment and planning; (2) policies and procedures; (3) communication; and (4) training. 
 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 care providers and suppliers to plan and execute 

appropriate emergency response procedures for disasters. We developed this proposed rule 

taking into consideration the extent of regulatory oversight that is currently in existence. 

We are proposing requirements for facilities to ensure the continued provision of 

necessary care at the facility or, if needed, the evacuation and transfer of patients to a location 

that can supply necessary care. Regulations that address these functions too specifically may 

become outdated over time as technology and the nature of threats change. However, as our 

analysis of existing regulations, and the OIG and GAO reports discussed in section I. of this 

proposed rule, indicate regulations that are too broad may be ineffective. Our challenge is to 

develop core components that can be used across provider and supplier types as diverse as 

hospitals, organ procurement organizations, and home health agencies, while tailoring 

requirements for individual provider and supplier types to their specific needs and circumstances, 

as well as the needs of their patients, residents, clients, and participants. 

We have identified four core elements that we believe are central to an effective 

emergency preparedness system and must be addressed to offer a more comprehensive 

framework of emergency preparedness requirements for the various Medicare- and 

Medicaid-participating providers and suppliers. The four elements are--(1) risk assessment and 

planning; (2) policies and procedures; (3) communication; and (4) training and testing. We have 

also proposed an additional requirement for OPOs entitled "Agreements with other OPOs and 

hospitals." 
 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 level, for example, a system for 

preserving medical documentation. Our regulatory requirements for each provider and supplier 

type are based on the comprehensive emergency preparedness requirements that we are 

proposing for hospitals. Since we are aware that the application of the proposed regulatory 

language for hospitals may be inappropriate or overly burdensome for some providers and 

suppliers, we have used the proposed hospital requirements as a template for our proposed 

emergency preparedness regulations for other providers and suppliers but have specific proposed 

requirements tailored to each providers' and suppliers' unique needs. Any contracted services 

furnished to patients must be in compliance with all the facilities' CoPs and standards of this rule, 

and all services must be provided in a safe and effective manner. 

All providers and suppliers would be required to establish an emergency preparedness 

plan that addressed the four core elements noted previously. The proposed requirements vary 

based on the type of provider. We discuss the hospital requirements in detail at the beginning of 

this section. The subsequent discussion of the proposed requirements for all remaining providers 

and suppliers focuses on how the requirements differ from those proposed for hospitals and why. 

For example, because they are inpatient facilities, religious nonmedical health care 

institutions (RNHCIs), psychiatric residential treatment facilities (PRTFs), skilled nursing 

facilities and nursing homes (referred to in this document as long term care (LTC) facilities), 

intermediate care facilities individuals with intellectual disabilities (ICFs/IID), and critical 

access hospitals (CAHs) may have greater responsibility than outpatient facilities during an 

emergency for ensuring the health and safety of persons for whom they provide care, their 
 40

employees, and volunteers. Thus, proposed requirements for RNHCIs, PRTFs, ICFs/IID, LTC 

facilities, and CAHs are similar to those proposed for hospitals. 

In the event of a natural or man-made disaster, providers and suppliers of outpatient 

services, such as ambulatory surgical centers (ASCs), programs of all-inclusive care for the 

elderly (PACE) organizations, home health agencies (HHAs), comprehensive outpatient 

rehabilitation facilities (CORFs), rural health clinics (RHCs), federally qualified health centers 

(FQHCs), and end stage renal disease (ESRD) facilities, may not open their facilities or may 

close them, sending patients and staff home or to a place where they can safely shelter in place. 

However, we recognize that outpatient facilities may find it necessary to shelter their patients 

until they can be evacuated or may be called upon to provide some level of care for community 

residents in the event of an emergency. For example, a CORF that is housed in a large building 

may open its doors to persons in the community who would otherwise have no place to go. The 

CORF may provide only shelter from the elements or may provide water, food, and basic 

self-care items, if available. 

Finally, given that some hospice facilities provide both inpatient and home based 

services, and that transplant centers and OPOs are unique in their provision of health care, our 

proposed requirements are tailored even more specifically to address the circumstances of these 

entities. We believe lessons learned following the 2005 hurricanes and subsequent disasters, 

such as the flooding in the Midwest in 2008, and the tornadoes and flooding in 2011and 2012, 

have provided us with an opportunity to work collaboratively with the health care community to 

ensure best practices in emergency preparedness across providers and suppliers. 

It is important to point out that we expect that implementation of certain requirements 

that we propose for providers and suppliers would be different, based on the category of the 
 41

provider or supplier. For example, we propose that nearly all providers and suppliers would be 

required to have policies and procedures to provide subsistence needs to staff and patients during 

an emergency. However, a small RHC's implementation of this requirement would be quite 

different from a large metropolitan hospital's implementation. Specifically, with respect the 

proposed requirement that hospitals, CAHs, inpatient hospice facilities, PRTFs, LTC facilities, 

ICFs/IID, and RNHCIs would be required to maintain various subsistence needs, we are 

requesting public comment regarding whether this should be a requirement and in what 

quantities and for what time period these subsistence needs would be maintained. Nevertheless, 

we expect that each facility would determine how to implement a requirement considering 

similar variables such as whether the provider might have the option of notifying staff and 

patients not to come to the facility due to an emergency; the number of staff and patients likely to 

be in the facility at the time of an emergency; whether the provider would have the capability of 

providing shelter, provisions, and health care to members of the community; and the amount of 

space within the facility available for storing provisions. Although various providers and 

suppliers utilize different nomenclature to describe the individuals for whom they provide care 

(patient, resident, client, or participant), unless otherwise indicated, we will use the term 

"patients" to refer to the individuals for whom the provider or supplier under discussion provides 

care. 

Data regarding the number of providers cited in this proposed rule were obtained from a 

variety of different CMS databases. The number of providers and suppliers deemed by 

accrediting organizations to meet the Medicare conditions of participation are from CMS's 

second quarter fiscal year 2010 Accrediting Organization System for Storing User Recorded 
 42

Experiences (ASSURE) database. Currently, there are accrediting organizations with Medicare 

deeming authority for hospitals, critical access hospitals, HHAs, hospices, and ASCs. 

Data for CAHs that report having psychiatric and rehabilitation Distinct Part Units 

(DPUs) are from the Medicare Quality Improvement and Evaluation System 

(QIES)/Certification and the Survey Provider Enhanced Reporting (CASPER) system as of 

March 2013. Data for CAHs that do not have DPUs are from the Online Survey, Certification, 

and Reporting (OSCAR) data system as of March 2013. Data for the number of transplant 

centers are from the CMS website as of March 2013. Data for the total number of accredited and 

non-accredited hospitals, HHAs, ASCs, hospices, RHNCHIs, PRTFs, SNFs, ICFs/IID, CORFs, 

OPOs, and RHCs/FQHCs are from the OSCAR data system as of March 2013. We acquired the 

PACE data from CMS's Health Plan Management System (HPMS), which reports the number of 

PACE contracts. Given that PACE organizations may have more than one "center," we are using 

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

the CMS. 

Note that the CMS OSCAR data system is updated periodically by the individual states. 

Due to variations in the timeliness of the data submissions, all numbers are approximate, and the 

number of accredited and non-accredited facilities shown may not equal the total number of 

facilities. 

 Discussion of the proposed regulatory provisions for each type of provider and supplier 

follows the discussion in this section of the hospital requirements in the order in which they 

would appear in the Code of Federal Regulations (CFR). However, our discussion of the 

hospital requirements includes a general discussion of the differences between our proposed 

requirements, based on whether providers and suppliers provide outpatient services or inpatient 
 43

services or both. Thus, we encourage all providers to read the discussion of the proposed 

hospital emergency preparedness requirements in section II.A. of this proposed rule. 

This section also provides detailed discussion of each proposed hospital requirement, 

offers resources that providers and suppliers can use to meet these proposed requirements, offers 

a means to establish and maintain emergency preparedness for their facilities, and provides links 

to guidance materials and toolkits that can be used to help meet these requirements. 

A. Emergency Preparedness Regulations for Hospitals (§ 482.15)

 Section 1861(e) of the Act defines the term "hospital" and subsections (1) through (8) list 

requirements that a hospital must meet to be eligible for Medicare participation. Section 

1861(e)(9) of the Act specifies that a hospital must also meet such other requirements as the 

Secretary finds necessary in the interest of the health and safety of individuals who are furnished 

services in the institution. Under the authority of 1861(e) of the Act, the Secretary has 

established in regulations at 42 CFR part 482 the requirements that a hospital must meet to 

participate in the Medicare program. 

 Section 1905(a) of the Act provides that Medicaid payments may be applied to hospital 

services. Regulations at § 440.10(a)(3)(iii) require hospitals to meet the Medicare conditions of 

participation (CoPs) to qualify for participation in Medicaid. The hospital CoPs are found at 

§ 482.1 through § 482.66. 

As of September 2012, 4,928 hospitals participated in Medicare. CAHs that have distinct 

part units (DPUs) must comply with all of the hospital CoPs with respect to those units. There 

are 1,332 active CAHs. Of these CAHs, there are 95 CAHs with DPUs. The remainder of 

CAHs (the vast majority) are not subject to hospital CoPs, and must comply with CAH-specific 

CoPs. Proposed requirements for CAHs are laid out in §485.625.
 44

 Services provided by hospitals encompass inpatient and outpatient care for persons with 

various acute or chronic medical or psychiatric conditions, including patient care services 

provided in the emergency department. Hospitals are the focal points for health care in their 

respective communities; thus, it is essential that hospitals have the capacity to respond in a 

timely and appropriate manner in the event of a natural or man-made disaster. Additionally, 

since Medicare-participating hospitals are required to evaluate and stabilize every patient seen in 

the emergency department and to evaluate every inpatient at discharge to determine his or her 

needs and to arrange for post-discharge care as needed, hospitals are in the best position to 

coordinate emergency preparedness planning with other providers and suppliers in their 

communities. 

 We are proposing a new requirement under 42 CFR 482.15 that would require that 

hospitals have both an emergency preparedness program and an emergency preparedness plan. 

Conceptually, an emergency preparedness program encompasses an approach to emergency 

preparedness that allows for continuous building of a comprehensive system of health care 

response to a natural or man-made emergency. We are also proposing that a hospital, and all 

other providers and suppliers, utilize an "all-hazards" approach in the preparation and delivery of 

emergency preparedness services in order to meet the health and safety needs of its patient 

population. The definition of "all hazards" is discussed later in this section under "Emergency 

Plan." 

 We would expect that during an emergency, injured and ill individuals would seek health 

care services at a hospital or CAH, rather than from another provider or supplier. For example, 

during a pandemic, individuals with influenza-like symptoms are more likely to visit a hospital 

or CAH emergency department than an ASC. Typically, in the event of a chemical spill, 
 45

affected individuals would not expect to receive emergency health care services at an LTC 

facility but would seek health care services at the hospital or CAH in their community. 

However, we believe it is imperative that each provider think in broader terms than their own 

facility, and plan for how they would serve similar and other healthcare facilities, as well as the 

whole community during and surrounding an emergency event. We believe the first step in 

emergency management is to develop an emergency plan. An emergency plan sets forth the 

actions for emergency response based on a risk assessment that addresses an "all-hazards 

approach" to medical and non-medical emergency events. In keeping with the emergency 

management industry and with strong recommendation from the Department's Assistant 

Secretary for Preparedness and Response (ASPR), we are proposing that all providers utilize an 

all-hazards approach to emergency response. We do not specify the quantity or the expected 

level of detail in which each hazard would be addressed by each provider; however, we do 

believe it would encourage the adoption of a well thought out, cohesive system of response both 

within and across provider types. 

Analysis of anticipated outcomes to the facility-based and community-based risk 

assessments would drive revision to the emergency preparedness program, the plan for response, 

or both. A facility-based risk assessment is contained within the actual facility and carried out 

by the facility. A community based risk assessment is carried out outside the organization within 

their defined community. 

1. Emergency Plan 

a. Emergency Planning Resources 

 To stimulate and foster improved emergency preparedness continuity of operations, the 

federal interagency community has developed fifteen all-hazards planning scenarios, entitled the 
 46

"National Planning Scenarios" for use in federal, state, and local homeland security preparedness 

activities. These scenarios serve as planning tools for response to the range of man-made and 

natural disasters the nation could face. The scenarios are: nuclear detonation-improvised 

nuclear device; biological attack – aerosol anthrax; biological disease outbreak – pandemic 

influenza; biological attack – plague; chemical attack – blister agent; chemical attack – toxic 

industrial chemicals; chemical attack – nerve agent; chemical attack – chlorine tank explosion; 

natural disaster – major earthquake; and natural disaster – major hurricane; radiological attack – 

radiological dispersal devices; explosive attack - bombing using improvised explosive device; 

biological attack – food contamination; biological attack – foreign animal disease (foot and 

mouth disease); and cyber attack. Additional scenarios include volcano preparedness and severe 

winter weather (snow/ice). Additional information regarding the National Planning Scenarios 

and how they align to the National Preparedness Goal can be found at: 

http://www.fema.gov/preparedness-1/learn-about-presidential-policy-directive8#MajorElements. 

 These planning tools along with other emergency 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, "Health Center Emergency Management Program 

Expectations," (No. 2007-15), dated August 22, 2007, at: 

http://bphc.hrsa.gov/policiesregulations/policies/pin200715expectations.html). While these 

materials were developed for health centers, the content is relevant to all health providers. 

According to the notice emergency management planning is to ensure predictable staff behavior 

during a crisis, provide specific guidelines and procedures to follow and define specific roles. 

Also, emergency planning should address the four phases of emergency management that 
 47

include: mitigation activities to lessen the severity and impact a potential disaster or emergency 

might have on a health center's operation; preparedness activities to build capacity and identify 

resources that may be used should a disaster or emergency occur; response to the actual 

emergency and controls the negative effects of emergency situations; and recovery that begin 

almost concurrently with response activities and are directed at restoring essential services and 

resuming normal operations to sustain the long-term viability of the health center. HRSA further 

states that for FQHCs, this means protecting staff and patients, as well as safeguarding the 

facility's ability to deliver health care. According to HRSA, the expectations outlined in their 

guidance are intended to be broad to ensure applicability to the diverse range of centers and to 

aid integration of the guidance into what centers already are doing related to emergency and risk 

management. While this guidance is targeted toward centers, we believe hospitals and all other 

providers and suppliers can use this guidance in the development of their emergency 

preparedness plans. 

The Agency for Healthcare Research and Quality (AHRQ) released a web-based 

interactive tool entitled, "Surge Tool Kit and Facility Checklist" (located at: 

http://www.cdc.gov/phpr/healthcare/documents/shuttools.pdf or at: 

http://archive.ahrq.gov/research/shuttered/toolkitchecklist/), which will allow hospitals and 

emergency planners to estimate the resources needed to treat a surge of patients resulting from a 

major disaster, such as an influenza pandemic or a terrorist attack. Designed to dovetail with the 

Homeland Security Council's 15 all-hazards National Planning Scenarios, previously discussed, 

the AHRQ Hospital Surge Model allows users to select a disaster scenario and estimate the 

number of patients needing medical attention by arrival condition and day; the number of 

casualties in the hospital by unit and day; and the cumulative number of both dead or discharged 
 48

casualties by day. The tool also calculates the level of hospital resources, including personnel, 

equipment and supplies, needed to treat patients. The model estimates resources for biological, 

chemical, nuclear or radiological attacks. (For the development of emergency preparedness 

plans, providers and suppliers may also find the National Fire Protection Association's (NFPA) 

NFPA 1600: "Standard on Disaster/Emergency Management and Business Continuity Programs, 

2013 Edition," particularly helpful. The NFPA document can be found at: 

http://www.nfpa.org/aboutthecodes/AboutTheCodes.asp?DocNum=1600. The standard sets 

forth the basic criteria for a comprehensive program that addresses disaster recovery, emergency 

management, and business continuity. Under most definitions, the NFPA 1600 is an industry 

standard for disaster management. 

Also of concern when developing an emergency plan is the issue of the allocation of 

scarce resources during a potentially devastating event. Disasters can create situations where 

such resources must be distributed in a manner that is different from usual circumstances, but 

still appropriate to the situation. As discussed in "Providing Mass Medical Care with Scarce 

Resources: A Community Planning Guide, Publication No. 07-0001, Rockville, MD: Agency 

for Healthcare Research and Quality," (found at: http://archive.ahrq.gov/research/mce/), such 

resource considerations are part of the impact that natural or man-made disasters have on 

hospitals. This guide provides information on the circumstances that communities would likely 

face as a result of a mass casualty event (MCE); key constructs, principles, and structures to be 

incorporated into the planning for an MCE; approaches and strategies that could be used to 

provide the most appropriate standards of care possible under the circumstances; examples of 

tools and resources available to help states and communities in their planning processes; and 

illustrative examples of how some health systems, communities, or states have approached 
 49

certain issues as part of their MCE-related planning efforts. Building on the work from 2008, the 

Institute of Medicine (IOM) released in 2012 a guidance report entitled "The Crisis Standards of 

Care (CSC): A Systems Framework for Catastrophic Disaster Response" available at: 

http://www.iom.edu/Reports/2012/Crisis-Standards-of-Care-A-Systems-Framework-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 substantial shift in normal health care activities 

and reallocation of staff, facilities, and resources; and that to transition quickly and effectively, 

each organization and agency has a responsibility to plan and identify in advance the core 

functions it must carry out in a crisis and who will be responsible for each task. 

Another resource that would be useful in helping planners address the issues associated 

with preparing for and responding to an MCE in the context of broader emergency planning 

processes is the document entitled, "Standing Together: An Emergency Planning Guide for 

America's Communities" (published by The Joint Commission (TJC), formerly known as the 

Joint Commission on the Accreditation of Healthcare Organizations, 2006). The document by 

TJC is a comprehensive resource that offers step-by-step guidance for development of an 

emergency preparedness plan that is applicable to small, rural, and suburban communities. This 

document can be found at: 

http://www.jointcommission.org/Standing_Together__An_Emergency_Planning_Guide_for_Am
 50

ericas_Communities/. This document may be particularly useful for small or rural facilities and 

agencies. 

Rural communities face challenges in the delivery of health care that are often very 

different from those faced by urban and suburban communities. While rural communities 

depend on public health departments, hospitals, and emergency medical services (EMS) 

providers just as urban and suburban communities do, rural communities tend to have fewer 

health care resources overall. A report entitled, "Rural Communities and Emergency 

Preparedness," (published by the Health Resources and Services Administration's (HRSA) Office 

of Rural Health Policy, April 2002, found at: 

ftp://ftp.hrsa.gov/ruralhealth/RuralPreparedness.pdf) addresses the issues faced by rural 

communities with respect to emergency preparedness. 

The authors report that there are many factors that limit the ability of rural providers and 

suppliers to deliver optimal health care services in the event of a natural or man-made disaster. 

The authors found that geographic isolation is a significant barrier to providing a coordinated 

emergency response. Rural areas are also more affected by variations in weather conditions and 

by seasonal variations in populations (for instance, tourism). As reported by the authors, these 

areas have fewer human and technical resources (that is, health care professionals, medical 

equipment, and communication systems). 

For example, the study found that in 2002, only 20 percent of the 3,000 local public 

health departments in the United States had developed a plan to deal with a bioterrorism event. 

The researchers also found that the majority of rural public health agencies are closed evenings 

and weekends, and are not equipped to respond to an emergency situation on a 24-hour basis. 

While these factors may not affect a rural hospital directly, as an integral part of the larger 
 51

system of health care delivery for its community, a hospital must be ready to manage the surge of 

persons who would seek care at the hospital during and after a disaster when many smaller health 

care entities may be non-operational. 

b. Risk Assessment 

To ensure that all hospitals operate as part of a coordinated emergency preparedness 

system, as outlined in the PPD-8, NIMS, NRF, HSPD-21, and PAHPA/PAHPRA, we are 

proposing at § 482.15 that all hospitals establish and maintain an emergency preparedness plan 

that complies with both federal and state requirements. Additionally, we propose that a hospital 

would develop and maintain a comprehensive emergency preparedness program, utilizing an 

"all-hazards" approach. The emergency preparedness plan would have to be reviewed and 

updated at least annually. 

In keeping with the focus of the emergency management field, we propose that prior to 

establishing an emergency preparedness plan, the hospital and all other providers would first 

perform a risk assessment based on utilizing an "all-hazards" approach. An all-hazards approach 

is an integrated approach to emergency preparedness planning. In the abstract of a 

November 2007 paper entitled, "Universal Design: The All-Hazards Approach to Vulnerable 

Populations Planning" by Charles K.T. Ishikawa, MSPH, Garrett W. Simonsen, MSPS, Barbara 

Ceconi, MSW, and Kurt Kuss, MSW, the researchers described an all-hazards planning approach 

as "a more efficient and effective way to prepare for emergencies. Rather than managing 

planning initiatives for a multitude of threat scenarios, all-hazards planning focuses on 

developing capacities and capabilities that are critical to preparedness for a full spectrum of 

emergencies or disasters." Thus, all-hazards planning does not specifically address every 
 52

possible threat but ensures that hospitals and all other providers will have the capacity to address 

a broad range of related emergencies. 

It is imperative that hospitals perform all-hazards risk assessment consistent with the 

concepts outlined in the National Preparedness Guidelines, the "Guidelines" published by the 

U.S. Department of Homeland Security that we described in section I.A.3 of this proposed rule. 

Additional guidance and resources for assistance with designing and performing a hazard 

vulnerability assessment include: the Comprehensive Preparedness Guide 201: Threat and 

Hazard Identification and Risk Assessment Guide (available at: 

http://www.fema.gov/library/viewRecord.do?fromSearch=fromsearch&id=5823), the Use of 

Threat and Hazard Identification and Risk Assessment for Preparedness Grants (available at: 

http://www.fema.gov/library/viewRecord.do?fromSearch=fromsearch&id=5826), the 

Preparedness Guide 201 Supplement 1: Threat and Hazard Identification and Risk Assessment 

Guide Toolkit (available at: 

http://www.fema.gov/library/viewRecord.do?fromSearch=fromsearch&id=5825), the Hazard 

Risk Assessment Instrument Workbook (available at: http://www.cphd.ucla.edu/hrai.html) and 

the Understanding Your Risks: Identifying Hazards and Estimating Losses document (available 

at: http://www.fema.gov/library/viewRecord.do?id=1880). 

Additionally, AHRQ published two additional guides to help hospital planners and 

administrators make important decisions about how to protect patients and health care workers 

and assess the physical components of a hospital when a natural or manmade disaster, terrorist 

attack, or other catastrophic event threatens the soundness of a facility. The guides examine how 

hospital personnel have coped under emergency situations in the past to better understand what 
 53

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

decisions. 

The guides entitled, "Hospital Evacuation Decision Guide" and "Hospital Assessment 

and Recovery Guide" are intended to supplement hospital emergency plans, augment guidance 

on determining how long a decision to evacuate may be safely deferred, and provide guidance on 

how to organize an initial assessment of a hospital to determine when it is safe to return after an 

evacuation. 

The evacuation guide distinguishes between "pre-event evacuations" which are 

undertaken in advance of an impending disaster, such as a storm, when the hospital structure and 

surrounding environment are not yet significantly compromised and "post-event evacuations," 

which are carried out after a disaster has damaged a hospital or the surrounding community. It 

draws upon past events including: the Northridge, CA, earthquake of 1994; the Three Mile Island 

nuclear reactor incident of 1979; and Hurricanes Katrina and Rita in 2005. The guide offers 

advice regarding sequence of patient evacuation and factors to consider when a threat looms. 

The assessment and recovery guide helps hospitals determine when to get back into a 

hospital after an evacuation. Comprised primarily of a 45-page checklist, the guide covers 

11 separate areas of hospital infrastructure that should be evaluated before determining that it is 

safe to reoccupy a facility, such as security and fire safety, information technology and 

communication and biomedical engineering. 

The "Hospital Evacuation Decision Guide" can be found at: 

http://archive.ahrq.gov/prep/hospevacguide/) (AHRQ Publication No.10-0009), and the 

"Hospital Assessment and Recovery Guide" can be found at (found at: 

http://archive.ahrq.gov/prep/hosprecovery/) (AHRQ Publication No. 10-0081). 
 54

Based on the guidance and information in these resources, we would expect a hospital's 

risk assessment, which we would require at § 482.15(a)(1), to be based on and include a 

documented, facility-based and community-based risk assessment, utilizing an all hazards 

approach. In order to meet this requirement, we would expect hospitals to consider, among other 

things, the following--(1) identification of all business functions essential to the hospitals 

operations that should be continued during an emergency; (2) identification of all risks or 

emergencies that the hospital may reasonably expect to confront; (3) identification of all 

contingencies for which the hospital should plan; (4) consideration of the hospital's location, 

including all locations where the hospital delivers patient care or services or has business 

operations; (5) assessment of the extent to which natural or man-made emergencies may cause 

the hospital to cease or limit operations; and (6) determination of whether arrangements with 

other hospitals, other health care providers or suppliers, or other entities might be needed to 

ensure that essential services could be provided during an emergency. 

We propose at § 482.15(a)(2) that the emergency plan include strategies for addressing 

emergency events identified by the risk assessment. For example, a hospital in a large 

metropolitan city may plan to utilize the support of other large community hospitals as alternate 

placement sites for its patients if the hospital needs to be evacuated. However, we would expect 

the hospital to have back-up evacuation plans for circumstances in which nearby hospitals also 

were affected by the emergency and were unable to receive patients. We would expect these 

plans to include consideration for how the hospital would work in collaboration with hospitals 

and other providers and suppliers across state lines, if applicable. Individuals who live near the 

border with an adjoining state could use the services of a hospital located in the adjoining state if 

the hospital was closer or provided more services than the nearest hospital in the state in which 
 55

the individual resides. Therefore, we would encourage hospitals in adjoining states to work 

together to formulate plans to provide services across state lines in the event of a natural or 

man-made disaster to ensure continuity of care during a disaster. 

c. Patient Population and Available Services 

At § 482.15(a)(3), we propose that a hospital's emergency plan address its patient 

population, including, but not limited to, persons at-risk. As defined by the PAHPA, members of 

at-risk populations may have additional needs in one or more of the following functional areas: 

maintaining independence, communication, transportation, supervision, and medical care. In 

addition to those individuals specifically recognized as at-risk in the statute (children, senior 

citizens, and pregnant women), we are proposing to define "at-risk populations" as individuals 

who may need additional response assistance including those who have disabilities, live in 

institutionalized settings, are from diverse cultures, have limited English proficiency or are 

non-English speaking, lack transportation, have chronic medical disorders, or have 

pharmacological dependency. Also, as discussed in "Providing Mass Medical Care with Scarce 

Resources: A Community Planning Guide," (http://archive.ahrq.gov/research/mce/ ), at-risk 

populations would include, but are not limited to, the elderly, persons in hospitals and nursing 

homes, people with physical and mental disabilities, and infants, and children. Hospitals may 

find this resource helpful in establishing emergency plans that address the needs of such patients. 

We also propose at § 482.15(a)(3) that a hospital's emergency plan address the types of 

services that the hospital would be able to provide in an emergency. The hospital should base 

these determinations on factors such as the number of staffed beds, whether the hospital has an 

emergency department or trauma center, availability of staffing and medical supplies, the 
 56

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

emergency. 

d. Succession Planning and Cooperative Efforts 

In regard to emergency preparedness planning, we are also proposing at § 482.15(a)(3) 

that all hospitals include delegations and succession planning in their emergency plan to ensure 

that the lines of authority during an emergency are clear and that the plan is implemented 

promptly and appropriately. 

Finally, at § 482.15(a)(4), we propose that a hospital have a process for ensuring 

cooperation and collaboration with local, tribal, regional, state, or federal emergency

preparedness officials' efforts to ensure an integrated response during a disaster or emergency 

situation, including documentation of the hospital's efforts to contact such officials and, when 

applicable, its participation in collaborative and cooperative planning efforts. We believe that 

planning with officials in advance of an emergency to determine how such collaborative and 

cooperative efforts will be achieved will foster a smoother, more effective, and more efficient 

response in the event of a disaster. 

While we are aware that the responsibility for ensuring a coordinated disaster 

preparedness response lies upon the state and local emergency planning authorities, the hospital 

would need to document its efforts to contact these officials and inform them of the hospital's 

participation in the coordinated emergency response. Although we propose to require the same 

efforts for all providers and suppliers as we propose for hospitals, we realize that federal, state, 

and local officials may not elect to collaborate with some providers and suppliers due to their 

size and role in the community. For example, a RNHCI, by the limited nature of its service 

within the community, may not be called upon to participate in such collaborative and 
 57

cooperative planning efforts. In this instance, we are proposing that such a provider or supplier 

would only need to provide documentation of its efforts to contact such officials and, when 

applicable, its participation. 

Through the work of its state partners, the ASPR Hospital Preparedness Program (HPP) 

has advanced the preparedness of hospitals and communities in numerous ways, including 

building healthcare coalitions, planning for all hazards, increasing surge capacity, tracking the 

availability of beds and other resources using electronic systems, and developing communication 

systems that are interoperable with other response partners. Many more community healthcare 

facilities have equipment to protect healthcare workers and decontaminate patients in chemical, 

biological, radiological, or nuclear emergencies. 

While the HPP program continues to encourage preparedness at the hospital level, 

evidence and real-world events have illustrated that hospitals cannot be successful in response 

without robust community healthcare coalition preparedness--engaging critical partners. Critical 

partners include emergency management, public health, mental/behavioral health providers, as 

well as community and faith-based partners. Together these partners make up a community’s 

Healthcare Coalition (HCC). A key goal of HPP moving forward is to strengthen the capabilities 

of the HCC, not just the individual hospital. HCCs are a cornerstone for the HPP and an integral 

component for community-wide planning for healthcare resiliency. 

We are aware that, among some emergency management leaders, healthcare coalitions 

are viewed as a valued and essential component of a coordinated system of response and that 

many providers now participate in such coalitions. While we are not requiring that providers 

participate in coalitions, we do recognize and support their value in the well-coordinated 

emergency response system and encourage providers of all types and sizes to engage in such 
 58

collaborations, where possible, to ensure better coordination in planning, including the 

assessment of risk, surrounding an emergency event. The primary goal of health care coalitions 

is to foster collaboration amongst provider types in order to strengthen the overall health system 

by leveraging expertise, sharing resources, and increasing capacity to respond; thus reducing 

potential administrative burden for emergency preparedness, while similarly enabling easier 

emergency response integration and coordination during an emergency. Healthcare coalition 

activities provide, at a minimum, an optimal forum for: leveraging leadership and operational 

expertise (health, public health, emergency management, public works, public safety, etc.) within 

a community; conducting mutual hazard vulnerability/risk assessments to identify community 

health gaps and develop plans and strategies to address them; developing standardized tools, 

emergency plans, processes and protocols, training and exercises to support the community and 

support ease of integration; and facilitating timely and/or shared resource management and 

coordination of communications and information during an emergency 

2. Policies and Procedures 

We are proposing at § 482.15(b) that a hospital be required to develop and implement 

emergency preparedness policies and procedures based on the emergency plan proposed at 

§ 482.15(a), the risk assessment proposed at § 482.15(a)(1), and the communication plan 

proposed at § 482.15(c). These policies and procedures would be reviewed and updated at least 

annually. We are soliciting public comment on the timing of the updates. 

We propose at § 482.15(b)(1) that a hospital's policies and procedures would have to 

address the provision of subsistence needs for staff and patients, whether they evacuated or 

sheltered in place, including, but not limited to, at (b)(1)(i), food, water, and medical supplies. 

Analysis of the disaster caused by the hurricanes in the Gulf states in 2005 revealed that hospitals 
 59

were forced to meet basic subsistence needs for community evacuees, including visitors and 

volunteers who sheltered in place, resulting in the rapid depletion of subsistence items and 

considerable difficulty in meeting the subsistence needs of patients and staff. Therefore, we are 

proposing that a hospital's policies and procedures also address how the subsistence needs of 

patients and staff who were evacuated would be met during an emergency. For example, a 

hospital might arrange for storage of supplies outside the facility, have contracts with suppliers 

for the acquisition of supplies during an emergency, or address subsistence needs for evacuees in 

an agreement with a facility that was willing to accept the hospital's patients during an 

emergency. 

Based on our experience with hospitals, most hospitals do maintain subsistence supplies 

in the event of an emergency. Thus, we believe it would be overly prescriptive to require 

hospitals to maintain a defined quantity of subsistence needs for a defined period of time. We 

believe hospitals and other inpatient providers should have the flexibility to determine what is 

adequate based on the location and individual characteristics of the facility. Although we 

propose requiring only that each hospital addresses subsistence needs for staff and patients, we 

recommend that hospitals keep in mind that volunteers, visitors, and individuals from the 

community may arrive at the hospital to offer assistance or seek shelter and consider whether the 

hospital needs to maintain a store of extra provisions. We are soliciting public comment on this 

proposed requirement. 

As stated earlier, we also have learned from attendance in the Hurricane Katrina Sharing 

Information During Emergencies (SIDE) conference held in July of 2006, and from on-going 

participation in the CMS Survey & Certification (S&C) Emergency Preparedness Stakeholder 

Communication Forum, that many facilities placed back-up generators in basements that 
 60

subsequently became inoperable due to water damage. In turn, this led to possible unsafe 

conditions for their patients and other persons sheltered in the facility. We note that existing 

regulations at §482.41 require hospitals to have emergency power and lighting in certain areas 

(operating, recovery, intensive care, emergency rooms, and stairwells). Emergency lighting only 

in these areas will not assist staff if there is a requirement to continue operations for long periods 

of time with no power (for example, in the wards). Power outages lasted several days after 

Hurricane Sandy in some areas of the northeast. Similarly, should a large-scale evacuation be 

required, a lack of emergency lighting in general areas of the hospital such as wards and 

corridors would greatly hinder this process. This was of particular concern in impacted 

healthcare facilities during Hurricane Sandy (Redlener I, Reilly M, Lessons from Sandy—

Preparing Health Systems for Future Disasters. N ENGL J MED. 367;24:2269-2271.) Thus, as 

previously stated, at § 482.15(b)(1)(ii) we also propose that the hospital have policies and 

procedures that address the provision of alternate sources of energy to maintain: (1) 

temperatures to protect patient health and safety and for the safe and sanitary storage of 

provisions; (2) emergency lighting; (3) fire detection, extinguishing, and alarm systems. We are 

also proposing at § 482.15(b)(1)(ii)(D) that the hospital develop policies and procedures to 

address provision of sewage and waste disposal. We are proposing to define the term "waste" as 

including all wastes including solid waste, recyclables, chemical, biomedical waste and 

wastewater, including sewage. These proposed requirements concern assuring the continuity of 

the power source for the fire detection, extinguishing and alarm systems and are an essential 

prerequisite for successful implementation of existing requirements during emergencies that 

result in loss of regular power. These proposed requirements are more in line with best practice 

rather than mere sufficiency. 
 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 that the hospital be able to track a patient's 

whereabouts, to ensure adequate sharing of patient information with other providers and to 

inform a patient's relatives and friends of the patient's location within the hospital, whether the 

patient has been transferred to another facility, or what is planned in respect to such actions. 

Therefore, we believe that hospitals must develop a means to track patients, which would include 

evacuees in the hospital's care during and after an emergency event. ASPR has developed tools, 

programs and resources to facilitate disaster preparedness planning at the local healthcare 

facility-level. One of these tools, The Joint Patient Assessment and Tracking System (JPATS), 

was developed through an interagency association between HHS/ASPR and DoD, and is 

available for providers at: https://asprwebapps.hhs.gov/jpats/protected/home.do 

Use of the JPATS is referenced in Health Preparedness Capabilities: National Guidance 

for Health System Preparedness (2012). This document provides guidance for healthcare 

systems, healthcare coalitions and healthcare organizations emergency preparedness efforts that 

is intended to serve as a planning resource. Broad guidance as to the requirement for bed and 

patient tracking is included. 

Given the lessons learned, this requirement is being proposed for providers and suppliers 

who provide ongoing care to inpatients or outpatients. Such providers and suppliers would 

include RNHCIs, hospices, PRTFs, PACE organizations, LTC facilities, ICFs/IID, HHAs, 

CAHs, and ESRD facilities. Despite providing services on an outpatient basis, we would require 

hospices, HHAs, and ESRD facilities to assume this responsibility. These providers and 

suppliers maintain current patient census information and would be required to provide 
 62

continuing patient care during the emergency. In addition, we would require ASCs to maintain 

responsibility for their staff and patients if patients were in the facility. Other outpatient 

providers, such as CORFs, FQHCs and clinics maintain patient information but they have the 

flexibility of cancelling appointments during an emergency thereby not needing to assume 

responsibility of the patients. 

This requirement is not being proposed for transplant centers; CORFs; OPOs; clinics, 

rehabilitation agencies as providers of outpatient physical therapy and speech-language 

pathology services; and RHCs/FQHCs. Transplant centers' patients and OPOs' potential donors 

would be in hospitals, and, thus, would be the hospital's responsibility. We believe it is likely 

that outpatient providers and suppliers would close their facilities prior to or immediately after an 

emergency, sending staff and patients home. 

We are not proposing a requirement for a specific type of tracking system. A hospital 

would have the flexibility to determine how best to track patients and staff, whether it used an 

electronic database, hard copy documentation, or some other method. However, it is important 

that the information be readily available, accurate, and shareable among officials within and 

across the emergency response system as needed in the interest of the patient. A number of 

states already have such tracking systems in place or under development and the systems are 

available for use by health care providers and suppliers. Lessons learned from the hurricanes in 

the Gulf States revealed that some facilities, despite having patient-related information backed 

up to computer databases within or outside of the state in which the disaster occurred, could not 

access the information in a timely manner. Therefore, we would recommend that a hospital 

using an electronic database consider backing up its computer system with a secondary source. 
 63

Although we believe that it is important that a hospital, and other providers of critical 

care, be able to track a patient’s whereabouts to ensure adequate sharing of patient information 

with other providers and to inform a patient’s relatives of the patient’s location after a disaster, 

we are specifically soliciting comments on the feasibility of this requirement for any outpatient 

facilities. 

 We propose at § 482.15(b)(3) that hospitals have policies and procedures in place to 

ensure the safe evacuation from the hospital, which would include standards addressing 

consideration of care and treatment needs of evacuees; staff responsibilities; transportation; 

identification of evacuation location(s); and primary and alternate means of communication with 

external sources of assistance. 

We propose at § 482.15(b)(4) that a hospital must have policies and procedures to 

address a means to shelter in place for patients, staff, and volunteers who remain in the facility. 

We expect that hospitals would include in their policies and procedures both the criteria for 

selecting patients and staff that would be sheltered in place and a description of the means that 

they would use to ensure their safety. 

During the Gulf Coast hurricanes, some hospitals were able to shelter their patients and 

staff in place. However, the physical structures of many other hospitals were so damaged that 

sheltering in place was impossible. Thus, when developing policies and procedures for 

sheltering in place, hospitals should consider the ability of their building(s) to survive a disaster 

and what proactive steps they could take prior to an emergency to facilitate sheltering in place or 

transferring of patients to alternate settings if their facilities were affected by the emergency. 

 We propose at § 482.15(b)(5) that a hospital have policies and procedures that would 

require a system of medical documentation that would preserve patient information, protect the 
 64

confidentiality of patient information, and ensure that patient records were secure and readily 

available during an emergency. In addition to the current hospital requirements for medical 

records located at § 482.24(b), we are proposing that hospitals be required to ensure that patient 

records are secure and readily available during an emergency. 

Such policies and procedures would have to be in compliance with Health Insurance 

Portability and Accountability Act (HIPAA) Privacy and Security Regulations at 45 CFR parts 

160 and 164, which protect the privacy and security of individual's personal health information. 

Information on how HIPAA requirements can be met for purposes of emergency preparedness 

and response can be found at: 

http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/index.html. The 

tornadoes that occurred in Joplin, Missouri in 2011, presented an example of the value of 

electronic health records during a disaster. There were primary care clinics and other providers 

that had electronic health records and because their records were not destroyed, they were able to 

find new locations, contact their patients and re-establish operations very quickly. 

We propose at § 482.15(b)(6) that facilities would have to have policies and procedures 

in place to address the use of volunteers in an emergency or other emergency staffing strategies, 

including the process and role for integration of state or federally designated health care 

professionals to address surge needs during an emergency. 

Facilities may find it helpful to utilize assistance from the Medical Reserve Corps 

(MRC), a national network of community-based volunteer units that focus on improving the 

health, safety and resiliency of their local communities. MRC units organize and utilize public 

health, medical and other volunteers to support existing local agencies with public health 

activities throughout the year and with preparedness and response activities for times of need. 
 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 Emergency System for Advance Registration of Volunteer Health 

Professionals (ESAR-VHP), found in section 107 of the Public Health Security and Bioterrorism 

Preparedness and Response Act of 2002 (Pub. L. 107-188), to verify the credentials of volunteer 

health care workers. The ESAR-VHP is a federal program to establish and implement guidelines 

and standards for the registration, credentialing, and deployment of medical professionals in the 

event of a large-scale national emergency. The program is administered by ASPR within the 

Department. All states must participate in ESAR-VHP. 

The purpose of the program is to facilitate the use of volunteers at all tiers of response 

(local, regional, state, interstate, and federal). The ESAR-VHP program has been working to 

establish a national network of state-based programs that manage the information needed to 

effectively use health professional volunteers in an emergency. These state-based systems will 

provide up-to-date information regarding the volunteer's identity and credentials to hospitals and 

other health care facilities in need of the volunteer's services. Each state's ESAR-VHP system is 

built to standards that will allow quick and easy exchange of health professionals with other 

states. We propose at § 482.15(b)(7) that hospitals would have to have a process for the 

development of arrangements with other hospitals and other providers to receive patients in the 

event of limitations or cessation of operations at their facilities, to ensure the continuity of 

services to hospital patients. 
 66

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

continuous care and services for individual patients. Thus, we are not proposing this requirement 

for transplant centers; CORFs; OPOs; clinics, rehabilitation agencies, and public health agencies 

as providers of outpatient physical therapy and speech-language pathology services; and 

RHCs/FQHCs. 

We also propose at § 482.15(b)(8) that hospital policies and procedures would have to 

address the role of the hospital under a waiver declared by the Secretary, in accordance with 

section 1135 of the Act, for the provision of care and treatment at an alternate care site (ACS) 

identified by emergency management officials. We propose this requirement for inpatient 

providers only. We would expect that state or local emergency management officials might 

designate such alternate sites, and would plan jointly with local providers on issues related to 

staffing, equipment and supplies at such alternate sites. This requirement encourages providers 

to collaborate with their local emergency officials in such proactive planning to allow an 

organized and systematic response to assure continuity of care even when services at their 

facilities have been severely disrupted. Under section 1135 of the Act, the Secretary is 

authorized to temporarily waive or modify certain Medicare, Medicaid, and Children's Health 

Insurance Program (CHIP) requirements for health care providers to ensure that sufficient health 

care items and services are available to meet the needs of individuals enrolled in these programs 

in an emergency area (or portion of such an area) during any portion of an emergency period. 

Under an 1135 waiver, health care providers unable to comply with one or more waiver-eligible 

requirements may be reimbursed and exempted from sanctions (absent any determination of 

fraud or abuse). Requirements to which an 1135 waiver may apply include Medicare conditions 

of participation or conditions for coverage and requirements under the Emergency Medical 
 67

Treatment and Labor Act (EMTALA). The 1135 waiver authority applies only to specific 

federal requirements and does not apply to any state requirements, including licensure. 

In determining whether to invoke an 1135 waiver (once the conditions precedent to the 

authority's exercise have been met), the ASPR with input from relevant HHS operating divisions 

(OPDIVs) determines the need and scope for such modifications, considers information such as 

requests from Governor's offices, feedback from individual healthcare providers and 

associations, and requests from regional or field offices for assistance. Additional information 

regarding the 1135 waiver process is provided in the CMS Survey and Certification document 

entitled, "Requesting an 1135 Waiver”, and located at: http://www.cms.gov/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 permitted under an 1135 waiver are no longer available 

after the termination of the emergency period. Generally, federally certified or approved 

providers must operate under normal rules and regulations, unless they have sought and have 

been granted modifications under the waiver authority from specific requirements. 

When a waiver has been issued under section 1135(b)(3) of the Act, EMTALA sanctions 

do not apply to a hospital with a dedicated emergency department, providing the conditions at 

§489.24(a)(2)(i) are met. The EMTALA part of the 1135 waiver only applies for a 72-hour 

period, unless the emergency involves a pandemic infectious disease situation (see 

42 CFR 489.24(a)(2)(ii)). Further information on the 1135 waiver process can be found at: 

http://www.cms.hhs.gov/H1N1/. 

Once an 1135 waiver is authorized, health care providers and suppliers can submit 

requests to operate under that authority to the CMS Regional Office, with a copy to the State 
 68

Survey Agency. The Regional Office or State Survey Agency may also be able to help providers 

and suppliers identify other relief that may be possible and which does not require an 1135 

waiver. 

This proposed requirement would be consistent with the ASPR's expectation that 

hospital grant awardees will continue to develop and improve their `` (ACS) plans and concept 

of operations for providing supplemental surge capacity within the health care system in their 

state. Further discussion of ASPR's expectation 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 and implementation would 

depend on close collaboration among state and local health departments (for example, state 

public health agencies, state Medicaid agencies, and state survey agencies), provider 

associations, community partners, and neighboring and regional health-care facilities. ASPR 

recommends that using existing buildings and infrastructure 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 assets. Federal assets may require 

what ASPR describes as an "environment of opportunity" for set up and operation and might not 

be available for as long as 72 hours. Therefore, ASPR believes it is critical that healthcare 

facilities, public health systems and emergency management agencies work with other 

emergency response partners when choosing a facility 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 state level response, we expect that hospitals 

would operationalize these efforts by working closely with the federal, state, tribal, regional, and 
 69

local communities. According to AHRQ's "Providing Mass Medical Care with Scarce 

Resources: A Community Planning Guide," the impact of an MCE of any significant magnitude 

will likely overwhelm hospitals and other traditional venues for health care services. AHRQ 

believes an MCE may render such venues inoperable, necessitating the establishment of ACSs 

for the provision of care that normally would be provided in an inpatient facility. According to 

AHRQ, advance planning is critical to the establishment and operation of ACSs; this planning 

must be coordinated with existing health care facilities, as well as home care entities. Planners 

must delineate the specific medical functions and treatment objectives of the ACS. Finally, 

AHRQ asserts that the principle of managing patients under relatively austere conditions, with 

limited supplies, equipment, and access to pharmaceuticals and a minimal staffing arrangement, 

is the starting point for ACS planning. 

Further discussion of the issues and challenges of establishing and operating ACSs during 

an MCE, as well as specific case study examples 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-hospital-based ACSs. It describes different types of ACSs, 

including critical issues and decisions that will need to be made regarding these sites during an 

MCE; addresses potential barriers; and includes examples of case studies. 

Subsequently, on October 1, 2009, AHRQ released two Disaster Alternate Care Facility 

Selection Tools, entitled the "Disaster Alternate Care Facility Selection Tool" and the "Alternate 

Care Facility Patient Selection Tool to help emergency planners and responders select and run 

alternate care facilities during disaster situations. These two tools can be found at: 

http://archive.ahrq.gov/prep/acfselection/pselectmatrix/(S(fidfow2u5az1o155srb0h1nb))/default.

aspx and at: 
 70

http://archive.ahrq.gov/prep/acfselection/acftool/(S(o53i55e3v452tl550uxvm055))/default.aspx. 

Under contract to AHRQ, Denver Health developed these new tools for AHRQ as an update to a 

previous alternate care site selection tool, entitled the Rocky Mountain Regional Care Model for 

Bioterrorist Events, which it developed in 2004 and can be found at: 

http://archive.ahrq.gov/research/altsites.htm#down. AHRQ led development of the tools with 

funding from the ASPR National Hospital Preparedness Program (HPP), formerly the HRSA 

Bioterrorism Hospital Preparedness 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 federal 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 hospital would be required at § 482.15(c)(1) to 

include in its plan, names and contact information for staff; entities providing services under 

arrangement; patients' physicians; other hospitals; and volunteers. During an emergency, it is 

critical that hospitals have a system to contact appropriate staff, patients' treating physicians, and 

other necessary persons in a timely manner to ensure continuation of patient care functions 

throughout the hospital and to ensure that these functions 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 emergency preparedness staff and other sources of 

assistance. Patient care must be well-coordinated 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 other 
 71

providers engaging in coalitions in their area for assistance in effectively meeting this 

requirement. 

We propose to require at § 482.15(c)(3) that hospitals have primary and alternate means 

for communicating with the hospital's staff and federal, state, tribal, regional, or local emergency 

management agencies, because in an emergency, a hospital's landline telephone system may not 

be operable. While we do not propose specifying the type of alternate communication system 

that hospitals must have, we would expect that facilities would consider pagers, cellular 

telephones, radio transceivers (that is, walkie-talkies), and various other radio devices such as the 

NOAA Weather Radio and Amateur Radio Operators' (HAM Radio) systems, as well as satellite 

telephone communications systems. In areas where 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 support qualifying federal, 

state, local, and tribal governments, 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 Telecommunications Services (GETS), 

Telecommunications Service Priority (TSP) Program, Wireless Priority Service (WPS), and 

Shared Resources (SHARES) High Frequency Radio Program at: www.ncs.gov. (Click on 

"services"). 
 72

Under this proposed rule, we would also require at § 482.15(c)(4) that hospitals have 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. Sharing of patient 

information and documentation was found to be a significant problem during the 2005 hurricanes 

and flooding in the Gulf Coast States. In some hospitals, patient care information in hard copy 

and electronic format was destroyed by flooding while, in others, patient information that was 

backed up to alternate sites was not always readily available. As a result, some patients were 

discharged or evacuated from facilities without 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 documentation 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 would ensure that information was sent with an 

evacuated patient to the next care provider or supplier, information would be readily available 

for patients being sheltered in place, and electronic information would be backed up both within 

and outside the geographic area where the hospital was located. 

Health care providers, who were in attendance during the Emergency Preparedness 

Summit in New Orleans, Louisiana in March 2007, discussed the possibility of storing patient 

care information on flash drives, thumb devices, compact discs, or other portable devices that a 

patient could carry on his or her person for ready accessibility. We would expect hospitals to 

consider the range of options that 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 event of an evacuation, 

to release patient information as permitted under 45 CFR 164.510 of the HIPAA Privacy 

Regulations. Thus, hospitals would need to have 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 "Standards for Privacy of Individually 

Identifiable Health Information," commonly known as "The Privacy Rule." 

This proposed requirement would not be applied to transplant centers; 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 suppliers who provide continuous care to patients, as 

well as to those providers and suppliers that have responsibilities and oversight for care of 

patients who are homebound or receiving services at home. 

We propose at § 482.15(c)(6) requiring hospitals to have 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) of the HIPAA Privacy Regulations. Section 

164.510(b)(4), "Use and disclosures for disaster relief purposes," establishes requirements for 

disclosing patient information to a public or private entity authorized by law or by its charter to 

assist in disaster relief efforts for purposes of notifying family members, personal 

representatives, or certain others of the patient's location or general condition. We are not 

proposing prescriptive requirements 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 have a means of providing information about 

the hospital's occupancy, needs, and its ability to provide assistance, to the authority having 

jurisdiction or the Incident 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 hospital to review and update 

the training and testing program at least annually. 

We believe a well organized, effective training program must include providing initial 

training in emergency preparedness policies and procedures. Therefore, we propose at 

§ 482.15(d)(1) that hospitals provide such training to all new and existing staff, including any 

individuals providing services under arrangement, and volunteers, consistent with their expected 

roles, and maintain documentation of such training. We propose that the hospital ensure that 

staff can demonstrate knowledge of emergency procedures, and that the hospital provides this 

training at least annually. 

While some large hospitals may have staff that 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 emergency preparedness training upon request. Thus, 

small hospitals and rural hospitals may find it helpful 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 assistance in effectively meeting this requirement. 

Conducting exercises at the healthcare coalition level could help to reduce the administrative 
 75

burden on individual healthcare facilities and demonstrate the value of connecting into the 

broader medical response community during disaster planning and response. Conducting 

integrated planning with state and local entities could identify potential gaps in state and local 

capabilities. Regional planning coalitions (multistate coalitions) meet and provide exercises on a 

regular basis to test protocols for state-to-state mutual aid. The members of the coalitions are 

often able to test command and control procedures and processes for sharing of assets that 

promote medical surge capacity. 

Regarding testing, at § 482.15(d)(2), we would require hospitals to conduct drills and 

exercises to test the emergency 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 hospital to conduct an individual, 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 emergency that required activation of the emergency 

plan, the hospital would be exempt from engaging in a community or individual, 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 exercise could be based on the same or a different 

disaster scenario from the scenario used in the mock disaster drill or the 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-relevant emergency scenario, and a set of problem 

statements, directed messages, or prepared questions designed to challenge an emergency plan." 

Comprehensive emergency preparedness includes anticipating and adequately addressing 

the various natural and man-made disasters that could impact a given facility. We expect that 
 76

hospitals would conduct both mock disaster drills and tabletop exercises, 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 designated "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 patients to "safe zones" in and outside of buildings 

during fire drills and other mock disaster drills is common industry practice. However, if it is 

not feasible to evacuate patients, hospitals could meet this requirement by moving its special 

needs patients to "safe zones" such as a foyer or other areas as designated by the hospital. To 

assist hospitals, other providers, and suppliers in conducting table-top exercises, we sought 

additional resources to further define the actions involved in a paper-based, tabletop exercise. 

One hospital system representative described a tabletop 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, the 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 leadership team's efforts to coordinate the 

response to an emergency event. 

The hospital representative further explained that the exercise consists of a group 

discussion led by a facilitator, using a narrated, clinically-relevant scenario, and a set of problem 

statements, directed messages, or prepared questions 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. Following the tabletop exercise, a 
 77

debriefing for hospital staff is held, and then the hospital staff provides written feedback and 

planning improvement suggestions to the hospital administration. 

Some hospitals may be well-versed in performing 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 Department of Health and Mental Hygiene has 

produced a very detailed document entitled, "Bioevent 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 suppliers that have limited or no emergency 

preparedness training experience. This document is designed to walk a facility through the 

process of performing a tabletop exercise 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 impact, and public health emergency scenarios for 

tabletop exercises, including the plague, Sever Acute Respiratory Syndrome (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 they attempt to meet this proposed emergency 

preparedness requirement. In 2005, the RAND Corporation produced a technical report for 

ASPR entitled, "Bioterrorism Preparedness Training and Assessment Exercises for Local Public 

Health Agencies," by Dausey, D. J., Lurie, N., Alexis, D., Meade, B., Molander, R. C., Ricci, K. 

A., Stoto, M. A., and Wasserman, J. 

(http://www.rand.org/pubs/technical_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 assess local public health agencies' (LPHAs) levels of preparedness 

over time. The exercises were beta tested and refined in 13 LPHAs across the United States over 

10 months. However, the report would be a useful 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 Agencies," 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 exercises in training, building relationships, 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 Secretary for Preparedness and 

Response, the U.S. Department of Homeland Security (DHS), and the CMS Survey and 

Certification Emergency Preparedness Stakeholder 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 voluntary, user-friendly tool for health care providers to use to 

document their performance during emergency planning exercises and real emergency events to 
 79

make recommendations for improvements for future performance. We do not mandate use of 

this AAR/IP template; however thorough completion of the template complies with our 

requirements for provider exercise documentation. 

 The "Health Care Provider After Action Report/Improvement Plan" template also meets 

requirements for hospitals or other health care providers 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 emergency management agencies and other 

governmental/non-governmental agencies. The HSEEP is a capabilities and performance-based 

exercise program that provides a standardized methodology and terminology for exercise design, 

development, conduct, evaluation, 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" template to best meet their needs. 

There are seven types of exercises defined 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 exercises include the following: 

● Seminar: A seminar is an informal discussion, 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 Training and Exercise Plan). 

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

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

procedures. 

● Games: A game is a simulation of operations that often involves two or more teams, 

usually in a competitive environment, using rules, 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 employed to test a single, 

specific operation or function within a single entity (for example, a nursing home conducts an 

evacuation drill). 

● Functional exercise (FE): A functional exercise examines or validates the 

coordination, command, and control between various multi-agency coordination centers (for 

example, emergency operation center, joint field office, 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 involving functional (for example, joint field 

office, emergency operation centers, etc.) and "boots on the ground" response (for example, 
 81

firefighters decontaminating mock victims). We expect hospitals to engage in such tabletop 

exercises to the extent possible in their communities. 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 system 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, and 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 Association (NFPA). We intend to require compliance with future 

LSC updates as may be adopted by CMS. The current LSC states that the hospital’s alternate 

source of power (for example, generator) and all connected distribution systems and ancillary 

equipment, must be designed to ensure continuity of electrical power to designated areas and 

functions of a health care facility. Also, the LSC (NFPA 110) states that the rooms, shelters, or 

separate buildings housing the emergency power supply shall be located to minimize the possible 

damage resulting from disasters such as storms, 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 continuous hours every 12 months at 100 percent of 

the power load the hospital anticipates it will require during an emergency. As a result of lessons 

learned from hurricane Sandy, we believe that this annual 4 hour test will more closely reflect 
 82

the actual conditions that would be experienced during a disaster of the magnitude of hurricane 

Sandy. 

We have also proposed the same emergency and standby power requirements for CAHs 

and LTC facilities. As such, we request information on this proposal and 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 based 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 provide guidance to the facilities in planning their 

emergency preparedness program and disaster planning.
 83

TABLE 1--EMERGENCY PREPAREDNESS REQUIREMENTS BY PROVIDER T

Provider Type Emergency Plan Policies and Procedures Communication Plan Training and Tes

Inpatient Providers 

Hospital *Develop a plan 

based on a risk assessment using an “all hazards” approach, which is an integrated approach focusing on capacities and capabilities critical to preparedness for a full spectrum of emergencies and disasters. The plan must be updated annually. 

*Develop and implement policies and procedures based on the emergency plan and risk assessment, which must be reviewed and updated at least annually. 

*Develop and maintain an emergency preparedness communication plan that complies with both federal and state law. Patient care must be well-coordinated within the facility, across health care providers and with state and local public health departments and emergency systems. 

*Develop and maintaitraining and testing programs, including itraining in policies anprocedures and demonknowledge of emergeprocedures and providtraining at least annuaConduct drills and exto test the emergency 

Critical Access Hospital 

* * * * 

Long Term Care Facility 

Must account for missing residents (existing requirement). 

* Share with 

resident/family/representative appropriate information from emergency plan (additional requirement). 

* 

PRTF * * * * 
 84

Provider Type Emergency Plan Policies and Procedures Communication Plan Training and Tes

ICF/IID Must account for 

missing clients (existing requirement). 

* Share with 

client/family/representative appropriate information from emergency plan (additional requirement). 

* 

RNHCI * * * No drills. Transplant Center 

* * * * 

Outpatient Providers--Outpatient providers are not required to provide subsistence needs for staff and patients

Hospice * In home services—

inform officials of patients in need of evacuation (additional requirement). 

In home services--will not need to provide occupancy information. 

* 

Ambulatory Surgical Center 

* * Will not need to provide 

occupancy information. 

* 

PACE * Inform officials of 

patients in need of evacuation (additional requirement). 

Will not need to provide occupancy information. 

* 

Home Health Agency 

* Will not require shelter 

in place, provision of care at alternate care sites. Inform officials of patients in need of evacuation (additional requirement). 

Will not need to provide occupancy information. 

* 
 85

Provider Type Emergency Plan Policies and Procedures Communication Plan Training and Tes

CORF Must develop 

emergency plan with assistance from fire, safety experts (existing requirement). 

Will not need to provide transportation to evacuation locations, or have arrangements with other CORFs to receive patients. 

Will not need to provide occupancy information. 

Assign specific emergpreparedness tasks to personnel. Provide instruction in locationalarm systems, signalfirefighting equip (exrequirements). 

CMHC * * * * OPO Address type of 

hospitals OPO has agreement (additional requirement). 

Needs to have system to track staff during & after emergency and maintain medical documentation (additional requirement). 

Does not need to provide occupancy info, method of sharing pt. info, providing info on general condition & location of patients. 

Only tabletop exercis

Clinics, Rehabilitation, and Therapy 

Must develop emergency plan with assistance from fire, safety experts. Address location, use of alarm systems and signals & methods of containing fire (existing requirements). 

* Does not need to provide 

occupancy information. 

* 

RHC/FQHC * Appropriate placement 

of exit signs (existing requirement). Does not have to track patients, or have arrangements with other RHCs to receive patients or have alternate care sites 

Does not need to provide occupancy information. 

* 
 86

Provider Type Emergency Plan Policies and Procedures Communication Plan Training and Tes

ESRD Must contact local 

emergency preparedness agency annually to ensure dialysis facility’s needs in an emergency (existing requirement). 

Policies and procedures must include emergencies regarding fire equipment, power failures, care related emergencies, water supply interruption & natural disasters (existing requirement). 

Does not need to provide occupancy information. 

Ensure staff demonstrknowledge of emergeprocedures, informing patients what to do, wgo, whom to contact iemergency occurs whpatient is not in facilit(alternate emergency number), how to discothemselves from dialymachine. Staff maintcurrent CPR certificatnursing staff trained iemergency equipmenemergency drugs, patorientation (existing requirements). 

*Indicates that the requirements are the same as those proposed for hospitals. 
 87

B. Emergency Preparedness Regulations for Religious Nonmedical Health Care Institutions 

(RNHCIs) (§ 403.748)

Section 1861(ss)(1) of the Act defines the term "Religious Nonmedical Health Care 

Institution" (RNHCI) and lists the requirements that a RNHCI must meet to be eligible for 

Medicare participation. 

We have implemented these provisions in 42 CFR part 403, Subpart G, "Religious 

Nonmedical Health Care Institutions" Benefits, Conditions of Participation, 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 all applicable federal, state, and local laws 

and regulations, which furnishes only non-medical 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 inconsistent with their religious beliefs. The religious 

non-medical care or religious method of healing means care provided under the established 

religious tenets that prohibit conventional or unconventional medical care for the treatment of the 

patient and exclusive reliance on the religious 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 for hospital or skilled nursing facility care but 

for whom medical care is inconsistent with their religious beliefs. Medicare does not cover the 

religious aspects of care. Nonmedical items and services are furnished to inpatients exclusively 

through nonmedical nursing personnel. Such Medicare coverage would include both nonmedical 

items that do not require a doctor's order or prescription (such as wound dressings or use of a 
 88

simple walker during a stay) and non-religious health care items and services (such as room and 

board). 

The RNHCI does not furnish medical items and services (including any medical 

screening, examination, diagnosis, prognosis, treatment, 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 within § 403.742, Condition of participation: 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 requires that the RNHCI 

provide emergency power for emergency lights, for fire detection and alarm systems, and for fire 

extinguishing systems. Section 403.742(a)(4) requires that the RNHCI have a written disaster 

plan that addresses loss of water, sewage, power and other emergencies. 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 framework for ensuring the health and safety 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 analysis. The proposed policies and procedures at 

§ 403.748(b)(1) would require that RNHCIs provide for subsistence needs for staff and patients, 

whether they evacuate or shelter in place, including, but not limited to, food, water, sewage and 
 89

waste disposal, non-medical supplies, 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, emergency 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 approach, including the loss of 

power, water, sewage and waste disposal. However, at proposed § 403.748(b)(1)(i) for RNHCIs, 

we have removed the terms "medical and nonmedical" to reflect typical RNHCI practice. 

RNHCIs do not provide most medical supplies. At § 482.15(b)(3), we would require hospitals to 

have policies and procedures for the safe evacuation from the hospital, which would include 

consideration of care and treatment needs of evacuees; staff responsibilities; transportation; 

identification of evacuation location(s); and primary and alternate means of communication with 

external sources of assistance. However, at § 403.748(b)(3), we propose 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 documentation" 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 address the use of volunteers in an emergency or other staffing 

strategies, including the process and role for integration of state or federally designated health 

care professionals to address surge needs during an emergency. For RNHCIs, at proposed 
 90

§ 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 health care professionals" 

since it is not within the religious framework of a RNHCI to integrate care issues for their 

patients with health care professionals outside of the RNHCI industry. 

The proposed hospital requirements at § 482.15(b)(7) would require that hospitals 

develop arrangements with other 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. 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 information for: staff; entities providing services 

under agreement; patients' physicians; other hospitals; and volunteers. For RNHCIs, we propose 

substituting "next of kin, guardian or custodian" 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 require 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 written election statement made by the patient or his or 

her legal representative. Also, 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 care 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 provide 
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such a specific service in the community, we believe RNHCIs would not participate in 

performing such drills. We propose the RNHCI 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, facility-based mock disaster drill. Although we 

proposed for hospitals at § 482.15(d)(2)(ii) that if the hospital experienced 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 following the onset of the actual event, 

we are not proposing this requirement for RNHCIs. 

At § 482.15(d)(2)(iv), we propose to require hospitals 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 his or her legal representative and further 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 election will not prevent or delay access to medical 

services available under Medicare Part A in facilities other than RNHCIs. Thus, at 

§ 403.748(c)(4), we are proposing that election documentation be shared with other care 

providers to preserve continuity of care. 
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C. Emergency Preparedness Requirements for Ambulatory Surgical Centers (ASCs) (§ 416.54)

 Section 416.2 defines an ambulatory surgical center (ASC) as any distinct entity that 

operates exclusively for the purpose of providing surgical services to patients not requiring 

hospitalization, and in which the expected duration of services would not exceed 24 hours 

following an admission. 

Section 1833(i)(1)(A) of the Act 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 procedures that can be safely performed in 

either a hospital setting (inpatient or outpatient) or in a Medicare-certified ASC. 

Patients are examined immediately before surgery 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 are the minimum health and safety standards a 

facility must meet to obtain Medicare certification. The existing 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, staff and others in the facility; (2) coordinate the plan with state 

and local authorities; and (3) conduct drills, annually and complete 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 existing rules, we propose to remove existing 

§ 416.41(c). Existing § 416.41(c)(1) would be incorporated into 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 would 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 space and medical supplies) to the authority having jurisdiction 

(local, state agencies) or the Incident Command Center, or designee. However, we are not 

proposing that these facilities provide information regarding their occupancy, as we have 

proposed for hospitals, since the term "occupancy" usually refers to bed occupancy in an 

inpatient facility. We are not proposing that these facilities provide for 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, policies 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 these requirements are important and small or 

rural ASCs would be able to develop an appropriate emergency preparedness plan and meet our 

proposed requirements with the assistance of resources in their state and local community 

guidance. 

D. Emergency Preparedness Regulations for Hospices (§ 418.113)

Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA), 

Pub. L. 97–248, added section 1861(dd) to the Act to provide coverage for hospice care to 
 94

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 participate in Medicare and Medicaid. Under section 

1861(dd) of the Act, the Secretary is responsible for ensuring 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 agencies conduct surveys of hospices to assess their 

compliance with the CoPs. The CoPs found at part 418, Subparts C and D apply 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 identification, 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, and spiritual services through 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 may be served in their place 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 inpatient facilities operated by the hospice. 
 95

As of March 2013, there were 3,773 hospice facilities nationally. Under the existing 

hospice regulations, hospice inpatient facilities are required to have a written disaster 

preparedness plan that is periodically rehearsed with hospice employees, with procedures to be 

followed in the event of an internal or external disaster, and procedures for the care of casualties 

(patients and staff) arising from such disasters. This requirement, which is limited in scope, is 

found at § 418.110(c)(1)(ii) under "Standard: Physical environment." 

We believe that all hospices, even those without inpatient facilities, should have an 

emergency plan. Also, we believe that, given the diverse nature of hospice patients and the 

variety of locations where they receive hospice services, simply having a written plan that is 

"periodically" rehearsed with staff does not provide sufficient protection for hospice patients and 

hospice employees. 

For hospices, we propose to retain existing regulations 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 emergency preparedness plan for 

managing the consequences of power failures, natural 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 periodically review and rehearse its emergency 

preparedness plan with hospice employees with special emphasis placed on carrying out the 

procedures necessary to protect 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 preparedness requirements for hospice providers are 

very similar to those for hospitals. However, the average hospice (freestanding, 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 facility. 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 caregiver 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 believe 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 facilities, 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 requirements that apply to all hospice providers at 

§ 418.113(b)(1) through § 418.113(b)(5) followed by requirements at § 418.113(b)(6) that apply 

only to hospice inpatient care facilities. 

Unlike our proposed hospital policies and procedures, we would require all hospices, 

regardless of whether or not they operate their own inpatient facilities, to have policies and 

procedures to inform state and local officials about hospice patients in need of evacuation from 

their respective residences at any time due to an emergency situation based on the patient's 
 97

medical and psychiatric condition and home environment. Such policies and procedures must be 

in accord with the HIPAA Privacy Rule, as appropriate. 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 additional proposed requirement recognizes the 

responsibility of the hospice to support the safety of its patients that reside in the community. 

We expect that hospices would be able to identify patients most in need of evacuation 

assistance (for example, patients residing alone and patients using certain types of durable 

medical equipment), safe and appropriate evacuation methods, and the appropriate state or local 

authorities to assist in such evacuations. We believe this requirement is necessary to ensure the 

safety of vulnerable hospice patients, who are likely not capable of evacuating without 

assistance. 

We note that the proposed requirements for communication at § 418.113(c) are the same 

as for hospitals, with the exception of proposed § 418.113(c)(7). At § 418.113(c)(7), for hospice 

facilities, we are proposing to limit to inpatients the proposed requirement that the hospice have 

policies and procedures that would include a means of providing information about the hospice's 

occupancy and needs, and its ability to provide assistance, to the authority having jurisdiction or 

the Incident Command Center, or designee. Since hospice facilities provide care to patients in 

the home or in an inpatient setting, we are proposing that only inpatient hospice facilities, 

including those under arrangement, be required to report the hospice facilities' inpatient 

occupancy. The proposed requirements for patients receiving care in their home would require 

only that hospices report their needs and ability to provide assistance. The proposed 

requirements for training and testing at §418.113(d) are similar to those proposed for hospitals. 
 98

E. Emergency Preparedness Regulation for Inpatient 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 conditions of participation (CoPs), 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 services for patients under age 21; services must 

be provided under the direction of a physician. Inpatient psychiatric services must involve active 

treatment which means implementation of a professionally developed and supervised individual 

plan of care. The patient's plan of care includes an integrated program of therapies, activities, 

and experiences designed to meet individual treatment 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 community resources to ensure continued services 

for the patient, his or her family, school, and community. 

The current PRTF requirements do not include any requirements for emergency 

preparedness. We propose requiring that PRTF facilities meet the same requirements we are 

proposing for hospitals. Because these facilities vary widely in size, we expect their risk 

analyses, emergency plans, emergency policies and procedures, emergency communication 

plans, and emergency preparedness training will vary widely as well. Nevertheless, we believe 

each of these providers/suppliers has the capability to comply fully with the requirements so that 
 99

the health and safety of its patients are protected in the event of an emergency situation or 

disaster. 

F. Emergency Preparedness Regulations for Programs of All-Inclusive Care for the Elderly 

(PACE) (§ 460.84)

The Balanced Budget Act (BBA) of 1997 established 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 participating in PACE must have a program agreement with 

CMS and a PACE organization. Regulations at § 460.2 describe the statutory authority that 

permits entities to establish and operate PACE 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 Senior Health Services, an organization that 

continues to serve seniors in San Francisco and surrounding areas of California. It is a unique 

model of managed care service delivery for the frail community-dwelling elderly. The PACE 

model of care includes the provision of adult day health care and interdisciplinary team care 

management as core services. Medical, therapeutic, ancillary, and social support services are 

furnished in the patient's residence or on-site at a PACE center. Hospital, nursing home, home 

health, and other specialized services are generally furnished under contract. 

Generally, a PACE organization provides medical 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 PACE adult day health center on a regular basis. 

On average, a PACE patient attends the day center 3 times a week. As of March 2013,there are 

91 PACE programs nationally. 
 100

Regulations for PACE organizations at part 460, subparts 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 Programs 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, and 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 emergencies 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 emergencies, 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 disasters 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 contractors) and patients to ensure 

that staff demonstrate a knowledge of emergency procedures, including informing patients what 

to do, where to go, and whom to contact in case of an emergency," would be incorporated into 
 101

proposed § 460.84(d)(1). The existing requirements for having available emergency medical 

equipment, for having staff who know how to use the equipment, and having a documented plan 

to obtain emergency medical assistance from outside sources in current § 460.72(c)(4) would be 

relocated to proposed § 460.84(b)(9). Finally, current § 460.72(c)(5), which 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 hospitals, with three exceptions. 

The first difference between the proposed hospital emergency preparedness requirements 

and the proposed PACE emergency preparedness requirements 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, water, 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, extinguishing, and alarm systems; 

and sewage and waste disposal as we are proposing for hospitals at § 482.15(b)(1). The second 

difference between the proposed hospital emergency preparedness requirements and the 

proposed PACE emergency preparedness requirements is that we propose adding at 

§ 460.84(b)(3), a requirement for a PACE organization to have policies and procedures to inform 

state and local officials about PACE patients in need of evacuation from their residences at any 

time due to an emergency situation based on the patient's medical and psychiatric conditions and 

home environment. Such policies and procedures must be in accord with the HIPAA Privacy 
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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 proposed 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 authority having jurisdiction or the 

Incident Command Center, or designee. We do not propose requiring these organizations to 

provide information regarding their occupancy, as we propose for hospitals (§ 482.15(c)(7)), 

since the term occupancy usually refers to bed occupancy in an inpatient facility. 

G. Emergency Preparedness Regulations for Transplant Centers (§ 482.78)

Transplant centers are located within hospitals that meet the requirements for Conditions 

of Participation (CoPs) in Medicare. Therefore, transplant centers must meet all hospital CoPs at 

§ 482.1 through § 482.57. In addition, unless otherwise specified, heart, heart-lung, intestine, 

kidney, liver, lung, and pancreas centers must meet all requirements for transplant centers at 

§ 482.72 through § 482.104. 

Transplant centers are responsible for providing organ transplantation services from the 

time of the potential transplant candidate's initial evaluation through the recipient's 

post-transplant follow-up care. In addition, if a center performs living donor transplants, the 

center is responsible for the care of the living donor from the 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 Transplantation 
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Network (OPTN) longstanding policy, if a transplant center must turn 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 Procurement, Distribution and Allocation, 

http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_6.pdf) . In such a 

situation, the patient on the 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 transplant. (http://optn.transplant.hrsa.gov/) 

There are 770 Medicare-approved transplant centers. 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 arrangements with one or more other Medicare-approved transplant 

centers to provide transplantation services and other 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 transplant centers would increase 

the odds that during an emergency, a transplant center's patients would receive critically 

important post-transplant care 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 specified in § 482.1 through § 482.57. Our proposed 

hospital CoP, "Emergency preparedness," at § 482.15, 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 the proposed CoP for emergency preparedness for 

transplant centers at § 482.78. We propose at § 482.78(a) that a transplant center have an 
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agreement with at least one other Medicare-approved transplant center to provide transplantation 

services and other care for its patients during 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 circumstances, a transplant center 

may wish to establish an agreement for the provision of post-transplant care and follow-up for its 

patients with a center that is Medicare-approved for a different organ type. 

We believe a transplant center entering into an agreement for the provision of services 

during an emergency would be in the best position to judge whether post-transplant care could be 

competently provided during an emergency by a Medicare-approved transplant center that 

transplanted a different organ type. We expect that transplant centers establishing such 

agreements would consider the types of services the other center had the ability 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 transplant 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 designated Organ Procurement Organization (OPO) that 

identifies specific responsibilities for the hospital and for the OPO with respect 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 addresses the duties and responsibilities of the 
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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 collaborate 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 hospitals at § 482.15(b)(1). Also, we are not 

proposing to require transplant centers to separately comply with the proposed hospital 

requirement at § 482.15(b)(8) regarding alternate care sites identified by emergency management 

officials. This requirement would be applicable to inpatient providers since the overnight 

provision of care could be challenged in an emergency. Transplant centers would have to meet 

this requirement since the transplant patient would 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 defines a skilled nursing facility (SNF) for Medicare purposes 

as an institution or a distinct part of an institution that is primarily engaged in providing skilled 

nursing care and related services to patients that require medical or nursing care or rehabilitation 

services due to an injury, disability, 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: skilled 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-related care and services to individuals who due to their mental or 

physical condition require care and services (above the level of room and board) that are 

available only through an institution. 
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To participate in the Medicare and Medicaid programs, long-term care (LTC) facilities 

must meet certain requirements located at part 483, Subpart B, Requirements for Long Term 

Care Facilities. SNFs must be certified as meeting the requirements of section 1819(a) through 

(d) of the Act. NFs must be certified as meeting section 1919(a) through (d) of the Act. A LTC 

facility may be both Medicare and Medicaid approved. 

LTC facilities provide a substantial 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 facilities 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 that a "facility 

must have detailed written plans and procedures to meet all potential emergencies and disasters, 

such as fire, severe weather, and missing residents." 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 they begin to work in the facility, periodically 

review the procedures with existing staff, and carry out unannounced staff drills using those 

procedures." These requirements would be incorporated 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 ensure 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 federal emergency management officials to provide 

assistance. For example, current LTC facility requirements do not require facilities to conduct a 

risk assessment or to have a plan, policies, or procedures to ensure continuity of facility 
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operations during emergencies. We believe the additional requirements in this proposed rule 

would ensure facilities would be prepared for 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 would 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 unlike many of the inpatient care providers. 

Many of the residents can be expected to have long term or extended stays in these facilities. 

Due to the long term nature of their stays, these 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 preparedness communication plan, which includes, among other things, a 

means of providing information about the general condition and location of residents under the 

facility's care. We also believe that the residents and their families or representatives require 

more information about the facility's emergency 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 representatives and that the facility have a means by which 

that information is disseminated to those individuals. The facility should also determine 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 most appropriate to be shared with its residents and their families or 
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representatives and the most efficient manner in which to share that information. 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 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 emergency power system inspection and testing requirements found 

in NFPA 99 and NFPA 110 and NFPA 101, we propose 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 anticipates it will require during an emergency. 

In addition to the emergency energy requirements discussed earlier, we also believe that 

LTC facilities should consider their 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 other things, its resident population and continuity 

of operations in its emergency plan. The LTC facility 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 individual residents’ power needs and should be 

included in LTC facilities’ risk assessments and emergency plans. However, we are also 

soliciting comments on whether there should be a specific requirement for “residents’ power 

needs” in the LTC requirements. 
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I. Emergency Preparedness Regulations for Intermediate Care Facilities for Individuals with 

Intellectual Disabilities (ICFs/IID) (§ 483.475)

Section 1905(d) of the Act created the ICF/IID benefit to fund "institutions" with four or 

more beds to serve people with [intellectual disability] 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 March 2013, there were 6,442 ICFs/IID, serving 

approximately 129,000 patients, and all patients receiving ICF/IID services must qualify 

financially for Medicaid assistance. Patients with intellectual disabilities who receive care 

provided by ICFs/IID may have additional emergency planning and preparedness requirements. 

For example, some care recipients are non-ambulatory, or may experience additional mobility or 

sensory disabilities or impairments, 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 meeting the proposed requirements. 

In fact, small facilities might find it easier than large facilities to develop an emergency 

preparedness plan and emergency preparedness policies 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 transportation during an emergency situation or disaster. 

 Because ICFs/IID vary widely in size and the services they provide, we expect that the 

risk analyses, emergency plans, emergency policies and procedures, emergency communication 

plans, and emergency preparedness training will vary widely as well. Nevertheless, we believe 
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each of them has the capability to comply fully with the requirements so that the health and 

safety of its patients are protected in the event of an emergency situation or disaster. 

Thus, we propose requiring that ICFs/IID meet the same requirements we are proposing 

for hospitals, with two exceptions. At § 483.475(a)(1), we propose that ICFs/IID utilize an all 

hazards approach, including consideration for missing clients. We believe that in the event of a 

natural or man-made disaster, ICFs/IID would maintain responsibility for care of their own 

patient population but would not receive patients from the community. Also, because we 

recognize that all ICFs/IID patients have special needs, we propose requiring ICFs/IID to 

"address the special needs of its client population ..." at § 483.475(a)(3). 

In addressing the special needs of its client population, we believe that ICFs/IID should 

consider their 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. We believe that the currently proposed 

requirements at §483.475(a)(a risk assessment utilizing an all-hazards approach and that the 

facility address the special needs of its client population) encompass consideration of individual 

residents’ power needs and should be included in ICFs/IID’s risk assessments and emergency 

plans. However, we are also soliciting comments on whether there should be a specific 

requirement for “residents’ power needs” in the ICFs/IID CoPs. 

As we stated earlier, the purpose of this proposed rule is to establish requirements to 

ensure that Medicare/Medicaid providers and suppliers are prepared to protect the health and 

safety of patients in their care during more widespread local, state, and national emergencies. 

We do not believe the existing requirements for ICFs/IID are sufficiently comprehensive to 

protect patients during an emergency that impacts the larger community. For example, they do 
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not require facilities to plan for sheltering in place. 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, and other emergencies. 

However, we do not propose to relocate these existing facility staffing requirements at 

§ 483.430(c)(2) and § 483.430(c)(3) because they address staffing issues based on the number of 

patients per building and patient behaviors, 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, includes a standard for emergency plan and 

procedures at § 483.470(h) and a standard for evacuation drills at § 483.470(i). The standard for 

emergency plan and procedures at current § 483.470(h)(1) requires facilities to develop and 

implement detailed written plans and procedures to meet all potential emergencies and disasters, 

such as fire, severe weather, and missing clients. 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 the 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 care providers. Many of the clients can be 

expected to have long term or extended stays in these facilities. Due to the long term nature of 
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their stays, these facilities essentially become the clients' residences or homes. We believe this 

changes the nature of the relationship and duty to the clients and their families or representatives. 

Section 483.475(c) requires these facilities to develop an emergency preparedness 

communication plan, which includes, among other things, a means of providing information 

about the general condition and location of clients under the facility's care. We also believe that 

the clients and their families or representatives require more information 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 their families or representatives 

and that facilities have a means by which that information is disseminated to those individuals. 

The facility should also determine 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 most appropriate to be shared with its clients and 

their families or representatives and the most efficient manner in which to share that information. 

Therefore, we propose to add an additional requirement at § 483.475(c)(8) that reads, "A method 

for sharing information from the emergency plan that 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) specifies that facilities 

must hold evacuation drills at least quarterly for each shift of personnel under varied conditions 

to ensure that all personnel on all shifts are trained 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 emergency and disaster plans and procedures. 
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Currently § 483.470(i)(2) further specifies that facilities must evacuate patients during at least 

one drill each year on each shift; make special provisions for the evacuation of patients with 

physical disabilities; file a report and evaluation on each evacuation drill; and investigate all 

problems with evacuation drills, including accidents, and take corrective action. Further, during 

fire drills, facilities may evacuate patients to a safe area in facilities certified under the Health 

Care Occupancies Chapter of the Life Safety Code. 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 for 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 requirements that a home health agency (HHA) must meet to 

participate in the Medicare program. Home health services are covered for qualifying elderly 

and people with disabilities who are beneficiaries under the Hospital Insurance (Part A) and 

Supplemental Medical Insurance (Part B) benefits of the Medicare program. These services 

include skilled nursing care, physical, occupational, and speech therapy, medical social work and 

home health aide services which must be furnished by, or under arrangement with, an HHA that 

participates in the Medicare program and must be provided in the beneficiary's home. 

As of March 1, 2013, there were 12,349 HHAs participating 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 prevention of hospitalizations. 

With so many patients depending on the services of HHAs nationwide, it is imperative 

that HHAs have processes in place to address the safety of patients and staff and the continued 
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provision of services in the event of a disaster or emergency. However, there are no existing 

emergency preparedness requirements contained 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 additional 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 include plans for its patients during a natural or 

man-made disaster. We propose that the HHA include individual emergency preparedness plans 

for each patient as part of the comprehensive patient assessment at § 484.55. 

Second, because we learned from the experience of Hurricane Katrina that many 

medically compromised people were unable to escape 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 need 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. Such policies and procedures must be in accord 

with the HIPAA Privacy Regulations, as appropriate. Although we do not propose how such 

notification would take place, we expect that maintaining an accurate list of HHA patients would 

be necessary. However, we believe the potential need for assistance with such factors as 

transportation or evacuation, for example, could be addressed as an ongoing process of 

evaluating the patient's medical and psychiatric condition and home environment. 
 115

We are not proposing to require that HHAs meet all of the same requirements that we are 

proposing for hospitals. Since HHAs provide health care services only in patients' homes, we are 

not including proposed requirements for policies and procedures for 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 hospital requirement at § 482.15(b)(8) regarding the 

provision of care and treatment at alternate care sites identified by emergency management 

officials. This proposed requirement would be applicable only to inpatient providers. With 

respect to communication, we have not included 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 ability to provide assistance to the authority having 

jurisdiction or the Incident Command Center, or designee. 

 In developing its policies and procedures, we would expect an HHA to consider whether 

it would accept new referrals during a disaster or emergency situation, and how it would care for 

new patients. We also would urge HHAs to include a method for providing information to all 

new patients and their families about the role the 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. 
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K. Emergency Preparedness Regulations for Comprehensive Outpatient Rehabilitation 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 CORF 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 disabilities, at a single fixed 

location, by or under the supervision 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 established in regulations, at part 485, Subpart B, 

requirements that a CORF must meet to participate in the Medicare program. 

Currently § 485.64 "Conditions of Participation: 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 regulation requires that all personnel be 

knowledgeable with respect to these procedures, be trained in their 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 fire, safety, and other appropriate experts. The 

other elements under § 485.64(a) require that CORFs have: (1) procedures for prompt transfer of 

casualties and records; (2) procedures for notifying community emergency personnel; (3) 
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instructions regarding the location and use of alarm systems and signals and firefighting 

equipment; and (4) specification of evacuation routes and procedures for leaving the facility. 

Currently § 485.64(b) requires each CORF to: (1) provide ongoing training and drills for 

all personnel associated with the CORF in all aspects of disaster preparedness; and (2) orient and 

assign specific responsibilities regarding the facility's disaster plan to all new personnel within 

2 weeks of their first workday. 

Although these requirements are important, they do not address the coordination across 

providers and suppliers and across the various federal, state, and local emergency response 

systems necessary to ensure the health and safety 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, safety, and other appropriate experts. We do not 

propose to require CORFs to provide 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 emergency as we propose to require for 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 include consideration of care and treatment needs of 

evacuees; staff responsibilities; transportation; identification of evacuation location(s); and 

primary and alternate means of communication with external sources of assistance. We do not 

believe all of these requirements are appropriate for CORFs, which serve only outpatients. 

Therefore, at § 485.68(b)(1), we are proposing to require that CORFs have policies and 
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procedures for evacuation from the CORF, including staff responsibilities and needs of the 

patients. 

Because CORFs are outpatient facilities that provide 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 that a hospital must have a means of providing 

information about the general condition and location of patients as permitted under 

45 CFR 164.510(b)(4). 

We propose including in the CORF emergency 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 expect 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 patients who are living in the community, as we 

would expect of hospices, HHAs, and PACE facilities. An additional modification from what 

has been proposed for hospitals at § 482.15(c)(7), at § 485.68(c)(5), we propose to require 
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CORFs to have a communication plan that include a means of providing information about the 

CORF's needs and its ability to provide assistance 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 propose for hospitals, since the term occupancy 

usually refers to bed occupancy in an inpatient facility. 

Our goal is to ensure that we incorporate existing CORF disaster preparedness 

requirements into our proposed emergency preparedness rule. Although we believe the current 

CORF disaster preparedness requirements 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 requirement 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 relocated 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 require that the training 

program include instruction in the location and use of alarm systems and signals and firefighting 

equipment. We have incorporated these requirements at proposed § 485.68(d)(1). We propose 

to remove current § 485.64. 

L. Emergency Preparedness Regulations for Critical Access Hospitals (CAHs) (§ 485.625) 

Sections 1820 and 1861(mm) of the Act provide 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 meet 
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the CAH CoPs and 95 CAHs with psychiatric or rehabilitation distinct part units (DPUs) that 

must meet the hospital CoPs in order to receive payment for services provided to Medicare or 

Medicaid patients in the DPU. 

CAHs are small, generally rural, limited-service 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 staffed if there are no inpatients in the facility. However, in 

the event of an emergency, existing requirements state 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 immediately available by telephone or radio contact 

and available onsite within 30 minutes on a 24-hour basis or, under certain circumstances, within 

60 minutes. CAHs currently are required to coordinate 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 the health and safety of CAH patients 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-medical emergencies by training staff in handling 

emergencies, including prompt reporting of fires; extinguishing of fires; protection and, where 

necessary, evacuation of patients, personnel, and 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 flashlights in other areas; provide for fuel and water supply; and 

take other appropriate measures that are consistent with the particular conditions of the area in 
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which the CAH is located. Since CAHs are required to provide emergency services on a 24-hour 

a day basis, they must keep equipment, supplies, and medication used to treat emergency cases 

readily available. 

We propose to remove the current standard 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 would 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 disaster to provide critical 

care to individuals in their communities. Although 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 assistance 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 § 485.625(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 proposed § 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 emergency 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 emergency power system inspection and testing 

requirements found in NFPA 99 and NFPA 110 and NFPA 101, we propose that CAHs test their 
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emergency and stand-by-power systems for a minimum of 4 continuous hours every 12 months 

at 100 percent of the power load the CAH anticipates it will require during an emergency. 

M. Emergency Preparedness Regulation for Clinics, 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 Act, the Secretary has established CoPs that 

clinics, rehabilitation agencies, and public health agencies must meet when they provide 

outpatient physical therapy (OPT) and speech-language 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 receiving OPT and SLP services from 

these entities. The CoPs are set forth at part 485, Subpart H. 

Section 1861(p) of the Act describes "outpatient physical therapy services" to mean 

physical therapy services furnished by a provider of services, a clinic, rehabilitation agency, or a 

public health agency, or by others under an arrangement with, and under the supervision of, such 

provider, clinic, rehabilitation agency, or public health agency to an individual as an outpatient. 

The patient must be under the care of a physician. 

 The term "outpatient physical therapy services" also includes physical therapy services 

furnished to an individual by a physical therapist (in the physical therapist's office or the patient's 

home) who meets licensing and other standards prescribed by the Secretary in regulations, other 

than under arrangement with and under the supervision 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 the Secretary may find necessary. The term also 
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includes SLP services furnished by a provider of services, a clinic, rehabilitation agency, or by a 

public health agency, or by others under an arrangement. 

As of March 1, 2013, there are 2,256 clinics, rehabilitation agencies, and public health 

agencies that provide outpatient physical therapy and speech-language pathology services. In the 

remainder of this proposed rule and throughout the requirements, we use the term 

"organizations" instead of "clinics, 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 proposing to require that organizations have policies and 

procedures for evacuation from the organization, including staff responsibilities and needs of the 

patients. 

We believe these organizations comply with a provision similar to our proposed 

requirement for hospitals at § 482.15(c)(7) which states that a communication plan must include 

a means of providing information about the hospital’s occupancy, needs, and its ability to 

provide assistance, to the authority having jurisdiction, the Incident Command Center, or 

designee. At § 485.727(c)(5), we propose to require that 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 authority having jurisdiction (local and state agencies) or the 

Incident Command Center, or designee. We do not propose to require these organizations to 

provide information regarding their occupancy, as we proposed for hospitals, since the term 

"occupancy" usually refers to bed occupancy in an inpatient facility. 
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The current regulations at § 485.727, "Disaster preparedness," require these organization 

to have a disaster plan. The plan must be periodically rehearsed, with procedures to be followed 

in the event of an internal or external disaster 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 addressed throughout the proposed CoP, and we do 

not propose including the specific language in our proposed rule. 

However, existing § 485.727(a) also requires that the plan be developed and maintained 

with the assistance of qualified fire, safety, and other appropriate experts. Because this existing 

requirement is specific to existing disaster preparedness 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 records; (2) the location and use of alarm systems and signals; (3) 

methods of containing fire; (4) notification of appropriate persons, and (5) evacuation routes and 

procedures. Because transfer of casualties and records, notification of appropriate persons, and 

evacuation routes are addressed under policies and procedures in our proposed language, we do 

not propose to relocate these requirements. However, because the requirements for location and 

use of alarm systems and signals and methods of containing fire are specific for these 

organizations, we propose relocating these 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 trained, 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 promptly 
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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 specified 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 the Act, includes CMHCs as entities that are authorized to 

provide partial hospitalization 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 providers of services for purposes of provider 

agreement requirements but only with respect to providing partial hospitalization services. In 

2010 there were 207 Medicare-certified CMHCs 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, including specialized outpatient services for children, the elderly, 

individuals who are chronically mentally ill, and residents of the CMHC's service area who have 

been discharged from inpatient treatment at a mental health facility. 

• 24 hour-a-day emergency care services. 
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• Day treatment, or other partial 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 Children's Health Insurance Program Benefits Improvement and 

Protection Act of 2000 allows CMHCs to provide these services by contract if state law 

precludes the entity from providing 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 individuals who are not eligible for 

benefits under Title XVIII of the Act. 

To qualify for Medicare reimbursement, CMHCs must comply with requirements for 

coverage of partial hospitalization services at § 410.110 and conditions 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 believe it is appropriate 

to also require CMHCs to meet the same emergency 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 emergency response in the 

event of a disaster or emergency situation. We are proposing that CMHCs meet the same 

emergency preparedness requirements we propose 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 the event that clients and 
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staff were in the facility when a disaster or emergency situation occurred, we would expect the 

CMHC to encourage clients and staff to leave the facility 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 providing information about the CMHCs needs and 

its ability to provide assistance to the authority 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 preparedness plan with the assistance of federal, state, and local 

community resources. 

O. Emergency Preparedness Regulations for 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 requirements to be an OPO and designated by the 

Secretary for a specific Donation 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 their suitability for donation, obtaining consent 

from next-of-kin, managing potential donors to maintain organ viability, coordinating recovery 

of organs, and arranging for transport of organs to transplant centers. If an emergency affects an 
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OPO's ability to provide its services, organ procurement 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 located within hospitals, at proposed 

§ 486.360(a)(3), instead of addressing the patient population as proposed for hospitals at 

§ 482.15(a)(3), we propose that the OPO 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. 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 system to track the location 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 generally 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 address the provision of subsistence needs for staff and patients. 

Instead, we believe these responsibilities would rest upon the hospital. 
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In addition, at § 486.360(c), we are proposing only three requirements for an OPO's 

communication plan. An OPO's communication plan would include: (1) names and contact 

information for staff; entities providing services 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 emergency 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 agencies. We believe the additional proposed 

requirements regarding communication would specifically be a hospital's responsibility in caring 

for its patient population. 

Unlike the requirement we have proposed for 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 required 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 such a tabletop exercise. However, the OPO 

typically does not have physical possession 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 propose that each OPO have agreement(s) with one or more 

other OPOs to provide essential organ procurement services to all or a portion of the OPO's DSA 

in the event that the OPO cannot provide such services due to an emergency. We also propose 

that the OPO include within its agreements with 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 the OPO in the event of an emergency. 
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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 Clinic 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 emergency preparedness requirements are found at 

§ 491.6. 

Currently, an RHC is staffed with personnel that are required to provide medical 

emergency procedures as a first response to common life threatening injuries 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 medical emergencies during and after the FQHC's 

regularly scheduled hours. Therefore, FQHCs must provide for access to emergency care at all 

times. Clinics and centers have 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, including health care professionals. However, 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 provide in an emergency. We expect 

that they would evaluate their ability to provide services based on, but not limited to, the 
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facility's size, available human and material resources, geographic location, and ability to 

coordinate with community resources. Thus, while Medicare providers or suppliers in a large 

metropolitan community may be better able to provide 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 similar services during an emergency. 

We believe many RHCs and FQHCs would be able to develop a comprehensive 

emergency plan that addresses "all-hazards" policies and procedures, a communication plan, and 

training and testing by drawing upon a variety of resources 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/ruralhealth/RuralPreparedness.pdf is a good source. 

Although RHCs and FQHCs currently do not have specific requirements for emergency 

preparedness, they have requirements for "Emergency 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 requirement would be addressed at proposed 

§ 491.12(d)(1). At § 491.6(c)(2), the RHC or FQHC must place exit signs in appropriate 

locations. This requirement would be incorporated 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 measures that are consistent with 

the particular conditions of the area in which the facility is located. This requirement would be 

addressed throughout the proposed CoP for RHCs and FQHCs, particularly proposed 
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§ 491.12(a)(1), which requires the RHCs and FQHCs to perform a risk assessment based on an 

"all-hazards" approach. Current § 491.6(c) would be removed. 

We are proposing emergency preparedness requirements based on the requirements that 

we are proposing for hospitals, modified to address the specific characteristics of RHCs and 

FQHCs. We do not propose to require RHC/FQHCs to provide basic subsistence needs for staff 

and patients. Also, unlike that proposed for hospitals at § 482.15(b)(2), we are not proposing 

that RHCs/FQHCs have a system to track the location 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 consideration of care and treatment needs of 

evacuees; staff responsibilities; transportation; identification of evacuation location(s); and 

primary and alternate means of communication with external sources of assistance. We 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 appropriate 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 with other RHCs/FQHCs or other providers to 

receive patients in the event of limitations or cessation 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 alternate 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 a 
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means, in the event of an evacuation, to release patient information as permitted under 

45 CFR 164.510. Modified from what has been proposed for hospitals 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 about the RHCs/FQHCs needs and their ability to 

provide assistance to the authority having jurisdiction or the Incident Command Center, or 

designee. We do not propose requiring RHCs/FQHCs 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 End-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 the 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". Emergency preparedness requirements are located at 

§ 494.60(d), Condition: Physical environment, Standard: Emergency preparedness. We propose 

to relocate these existing requirements to proposed § 494.62, Emergency preparedness. 

Current regulations include the requirement that dialysis facilities be organized into 

ESRD Network areas. Our regulations describe these networks at § 405.2110 as 
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"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 emergencies, as they often arrange for alternate dialysis locations for 

patients and provide information and resources during emergency situations. As noted earlier, 

we do not propose incorporating the ESRD Network requirements into 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 place, including food, water, 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, 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 facilities to address in their policies and 

procedures, fire, equipment or power failures, care-related emergencies, water supply 

interruption, and natural disasters in the facility's geographic area. 

At § 482.15(b)(3), we propose that hospitals have policies and procedures for the safe 

evacuation from the hospital, which includes consideration of care and treatment needs of 

evacuees; staff responsibilities; transportation; identification of evacuation location(s); and 

primary and alternate means of communication with external sources of assistance. We do not 

believe all of these requirements are appropriate 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 evacuation from the facility, including 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 receive 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 that an organized system of patient care among 

ESRD facilities during and surrounding emergency events encompasses having a robust system 

for back-up care available at the 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 that include a means of providing 

information about their needs and their ability to provide assistance to the authority having 

jurisdiction or the Incident Command Center, or designee. We do not propose to require dialysis 

facilities to provide information 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 ESRD facilities to ensure that staff can 

demonstrate knowledge of various emergency procedures, including: informing patients of what 

to do; where to go, including instructions for occasions 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 information must include 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 the ability to forward calls to a working 
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phone number under such emergency conditions); and how to disconnect themselves from the 

dialysis machine if an emergency occurs. 

We would relocate existing requirements for patient training from § 494.60(d)(2) to 

proposed § 494.62(d)(3), patient orientation. In addition, 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 relevance of these requirements has already been 

established, and since they are existing regulations, they are standard 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). Current language that defines an emergency 

for dialysis facilities found at § 494.60(d) would be incorporated into proposed § 494.62(b). We 

would relocate existing requirements for emergency 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 the current requirements 

at § 494.60(d)(4)(iii) for contacting the local emergency preparedness agency at least annually to 

ensure that the agency is aware of dialysis facility's needs in the event of an emergency to 

proposed § 494.62(a)(4). We would also redesignate the current § 494.60(e) as § 494.60(d). 
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III. Collection of Information Requirements 

 Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in 

the Federal Register and solicit public comment before a collection 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 information collection burden on the affected 

public, including automated collection techniques. 

We are soliciting public comment on each of these 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 hospital’s ICRs would differ from the ICRs of 

other Medicare or Medicaid provider and supplier types. A significant factor in the burden for 

each provider or supplier type would be whether the type of facility provides inpatient services, 

outpatient services, or both. Moreover, even where the proposed regulatory requirements are the 

same, certain factors would greatly affect the burden for different providers and suppliers. 

Current Medicare or Medicaid regulations for some providers and suppliers include requirements 

similar to those in this proposed regulation. For example, existing regulations for RNHCIs and 
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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 preparedness standards. Those organizations are: The 

Joint Commission (TJC), the American Osteopathic Association (AOA), the Accreditation 

Association for Ambulatory Health Care, Inc. (AAAHC), the American Association for 

Accreditation for Ambulatory Surgery Facilities, 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 comprehensive emergency preparedness requirements for 

hospitals. Thus, as noted in the hospital discussion later in this section, we anticipate that TJCaccredited hospitals would have a smaller burden associated 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. "Bioterrorism and Mass Casualty Preparedness in 

Hospitals: United States, 2003," CDC, Advance 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 state 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 the hospitals spent this 

funding. Therefore, in determining the burden for this proposed rule, we did not take into 
 139

account any funding a hospital or other health care 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 discussion 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 information for the different positions 

identified in the following assessments from 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 estimated hourly rates based 

upon the national median salary for that particular position, including benefits. Where we were 

able to identify positions linked to specific providers 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 information 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 and 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 administrators less than the mean hourly wage for Health Service 

Managers in general medical and surgical hospitals. Thus, we considered the impact of the rural 
 140

nature of CAHs to estimate the hourly wage for CAH administrators and calculated total 

compensation by adding in an amount for fringe benefits. 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 total 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 with 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 and Human Services (HHS) 

• http://www.phe.gov 

Office of the Assistant Secretary for Preparedness and Response (ASPR) 

• http://www.phe.gov/about

Health Resources and Services Administration-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 Prevention – Emergency Preparedness & Response 

• www.emergency.cdc.gov
 141

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

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

Substance Abuse and Mental Health Services Administration (SAMHSA) – 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 Administration (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 and supplier type included in this proposed 

rule in the order in which they appear in the CFR. 

C. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 403.748)

 Proposed § 403.748(a) would require Religious Nonmedical Health Care Institutions 

(RNHCIs) to develop and maintain an emergency preparedness plan that must be reviewed and 

updated at least annually. We propose that the plan must meet the requirements specified at 
 142

§ 403.748(a)(1) through (4). We will discuss the burden for these activities individually 

beginning with the risk assessment requirement in § 403.748(a)(1). 

 The current RNHCI CoPs already require RNHCIs 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 quality 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 the tasks necessary to ensure 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 need 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 expect that complying with this requirement 

would require the involvement of an administrator, the director of nursing, and the head of 

maintenance. It is important to note that RNHCIs do not provide medical care to their patients. 

Depending upon the state in which they are located, RNHCIs may not be licensed and may not 

have licensed or certified staff. RNHCIs generally do not compensate their staff at the same 

level we have used to determine the burden for other health care providers and suppliers. 

Therefore, for the purpose of estimating the burden, we have used lower hourly wages for the 

RNHCI staff than for other providers and suppliers 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 meeting; perform a final 

review, and approve the risk assessment. We expect that the director of nursing would 

coordinate the meetings, review and critique the current risk assessment, coordinate comments, 

develop the new risk assessment, and 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 each RNHCI 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 emergency 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 plans 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 substantially 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. Therefore, for all 16 RNHCIs to comply with these 

requirements would require an estimated 192 burden hours (12 burden hours for each RNHCI x 
 144

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 expect that RNHCIs already review their plans 

annually. Based on our experience with Medicare providers and suppliers, 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 relevant federal, state, and local laws, regulations, and 

ordinances. While this requirement is subject to the PRA, we expect that complying with the 

requirement for an annual review of the emergency 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 accordance with their emergency plan based on the 

emergency plan set forth in paragraph (a) of this section, the risk assessment at paragraph (a)(1) 

of this section, and the communication plan at paragraph (c) of this section. These policies and 

procedures would have to be reviewed and updated at least annually. At a minimum, we propose 

that the policies and procedures be required 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, risk assessment, and communication plan. Most 

RNHCIs would need to revise their existing policies and procedures or develop new policies and 

procedures. 
 145

 The current RNHCI CoPs require them to have written policies concerning their services 

(42 CFR § 403.738). Thus, some RNHCIs may have some emergency preparedness policies and 

procedures. However, based on our experience with RNHCIs, most of their emergency 

preparedness policies address only evacuation from the facility. 

 We expect that these tasks would involve the administrator, the director of nursing, and 

the head of maintenance. All three would need to review and comment on the RNHCI’s current 

policies and procedures. The director of nursing would revise or develop new policies and 

procedures, as needed, ensure that they are approved, 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 propose 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 develop 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 maintenance. We estimate that complying with this 

requirement would require 4 burden hours for each 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 burden 
 146

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 annually. We believe that RNHCIs already review 

their emergency preparedness communication plans periodically. Thus, 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). 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 requirements specified at § 403.748(d)(1) and (2). 

Section 403.748(d)(1) would require RNHCIs to provide initial training in emergency 

preparedness policies and procedures 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 RNHCI 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 would 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 revise or, if necessary, develop 

new sections for their training programs. 

 We expect that complying with these requirements would require the involvement of the 

RNHCI administrator and the director 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 = 
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112 burden hours) at a cost of $3,488 ($218 estimated cost for each RNHCI x 16 RNHCI = 

$3,488 estimated cost). 

 We are proposing that RNHCIs also review and update their emergency preparedness 

training and testing programs at least annually. Based on our experience with Medicare 

providers and suppliers, 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 

relevant federal, state, and local laws, regulations, and ordinances. While this requirement is 

subject to the PRA, we expect that complying with this requirement 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 RNHCIs 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 emergency 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 emergency preparedness plans. However, we expect that RNHCIs 

would not be fully compliant with our proposed requirements. We expect that the director of 

nursing would develop the scenarios and required documentation. We estimate that these tasks 

would require 3 burden hours at a cost of $72 for each RNCHI. Based on this estimate, for all 

16 RNHCIs to comply with these requirements would require 48 burden hours (3 burden hours 
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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 COST ESTIMATES FOR ALL 16 RNHCIS 

TO COMPLY WITH THE ICRs CONTAINED 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 Coverage: Emergency Preparedness (§ 416.54)

 Proposed § 416.54(a) would require Ambulatory Surgical Centers (ASCs) to develop and 

maintain an emergency preparedness plan and review and update that plan at least annually. We 

propose that the plan must meet the requirements contained in § 416.54(a)(1) through (4). 

 We will discuss the burden for these activities 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 all-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 must 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 covering 
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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 status 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 the AOA or the AAAASF. The accreditation standards 

for these organizations vary in their requirements related to emergency preparedness. The 

AOA’s standards are very similar to the current 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 staff or patients; power 

failures; transferring patients; and emergency evacuation of the facility. However, the 

accreditation standards for 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 include 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 standards 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 proposed 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 the 
 150

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 separately 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 risk assessment in proposed § 416.54(a)(1), in the 

chapter entitled "Management of the Environment of Care" (EC), ASCs are required to conduct 

comprehensive, proactive risk assessments (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, Standard EC.4.10, EP 1, p. EC-12). The HVA requires 

the identification of potential emergencies and the 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 proposed requirement would be negligible. For the 

350 TJC-accredited ASCs, the risk assessment requirement would constitute a usual and 

customary business practice. While this requirement is subject to the PRA, we expect that 

complying with this requirement would constitute 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 Ambulatory Health Care 2008 (AHAHC). The AAAHC 

standards do not contain a specific requirement for the ASC to perform a risk assessment. 

However, in discussing the requirement for drills, the AAAHC notes that such drills should be 

appropriate to the facility’s activities and environment (AHAHC, Accreditation Association for 

Ambulatory Health Care, Inc., Core Standards, Chapter 8. Facilities and Environment, Element 

E, p. 37). Therefore, we expect that in fulfilling 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 documented, 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 performed 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-accredited ASCs would perform thorough reviews of their 

current risk assessments, if they have them, and revise them to ensure they have updated the 

assessments and that they have included all of the requirements in proposed § 416.54(a). 

 We have not designated any specific process 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 facilities to, at a minimum, include input from all of 
 152

their major departments in the process of developing their risk assessments. Based on our 

experience working with ASCs, we expect that conducting the risk assessment would require the 

involvement of an administrator and a quality improvement nurse. We expect that to comply 

with the requirements of this subsection, both of these individuals would need to attend an initial 

meeting, review the current assessment, prepare their comments, attend a follow-up meeting, 

perform a final review, and approve the risk assessment. 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 parties approve the new risk assessment. We estimate that complying 

with this risk assessment requirement would require 8 burden hours 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 requirement 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 would be required to develop and maintain 

emergency preparedness plans in accordance 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 disaster readiness and emergency management" 

(CAMAC, Standard EC.4.10, EP 3, EC-13). We expect 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 requirements, we expect that the burden would be 
 153

negligible. Thus, for 350 TJC-accredited ASCs, this requirement would constitute 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 have 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 plan. 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 need 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. The ASC would also need to review, revise, and, 

in some cases, develop the delegations of authority and succession plans that ASCs determine 

are necessary for the appropriate initiation and 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 experience 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 emergency 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 required to review and update their emergency 

preparedness plans at least annually. For the 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 improvement nurse, whose responsibility entails 

ensuring that the ASC is delivering quality patient care and that the ASC is complying with 

regulations concerning patient care. We expect that the quality improvement nurse would be 

primarily responsible for the annual review of the ASC’s emergency 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, the 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 and 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 emergency preparedness policies and procedures based 

upon their risk assessments, emergency preparedness plans, and communication plans. 
 155

Therefore, ASCs would need to thoroughly review their emergency preparedness policies and 

procedures and compare them to all of the information previously noted. The ASCs would then 

need to revise, or in some cases, develop new policies and procedures that would ensure that the 

ASCs’ emergency preparedness plans address the specific proposed elements. 

 The TJC accreditation standards already require 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 policies and procedures that guide and support 

patient care, treatment, and services" (CAMAC, Standard LD.3.90, EP 1, p. LD-12a). In 

addition, TJC-accredited ASCs must already address or perform a HVA; processes for 

communicating with and assigning staff under emergency conditions; provision of subsistence or 

critical needs; evacuation of the facility; and alternate sources for 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 emergency management plans in response to the critiques (CAMAC, 

Standard EC.4.20, EPs 12-16, pp. EC-14-14a). In the chapter entitled, "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 and 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). Therefore, 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 emergencies that may arise in connection with services 
 156

sought or provided" (AHAHC, Chapter 8. Facilities 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 satisfying 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 and procedures to ensure that they 

address all of the proposed requirements. We expect that the quality improvement nurse would 

initially review the ASC’s emergency preparedness policies and procedures. The quality 

improvement nurse would send any recommendations for changes or additional policies or 

procedures to the ASC’s administrator. The administrator and quality improvement nurse would 

need to make the necessary revisions and draft 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 information listed in § 416.54(c)(1) through (7). 
 157

The burden associated with developing and maintaining an emergency preparedness 

communication plan would be the time and effort necessary to review, revise, and, if necessary, 

develop new sections for the ASC’s emergency preparedness communications plan to ensure that 

it satisfied these requirements. 

 The TJC-accredited ASCs are required to have a plan that "identifies 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 requirements 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 necessary to satisfy the 

proposed requirements, we expect the revisions or additions would be those 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 for ASCs as stated in 5 CFR 

1320.3(b)(2). Thus, we will not include this activity 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 ASCs are required to have the "necessary 

personnel, equipment and procedures to handle medical 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 communications would be included in the AAAHC-accredited 
 158

ASC’s plans and procedures. However, we do not believe 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 outside sources of assistance; 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 patients. 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 review, 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 require the involvement of the ASC’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 review and update their emergency preparedness 

communication plans at least annually. We believe that ASCs already review their emergency 
 159

preparedness communication plans periodically. Therefore, complying with this requirement 

would constitute a usual and customary business practice for ASCs and would 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, and, in some cases, develop new sections for its 

emergency preparedness training program. We expect that all ASCs already provide training on 

their emergency preparedness policies and procedures. However, all ASCs would need to 

review their current training and testing programs and compare their contents to their risk 

assessments, emergency preparedness plans, policies 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 existing 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 practitioners (CAMAC, Standard 2.10, HR-8). They must also provide 

"on-going education, including in-services, 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 their facilities’ emergency preparedness policies 

and procedures in their current training programs. However, these requirements do not contain 
 160

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 complying with these requirements. Therefore, we 

will include these TJC-accredited ASCs in determining the burden for these requirements. 

 The AAAHC-accredited ASCs are already required 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 preparedness policies and procedures. However, this 

requirement does not include any requirement for annual 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 proposed requirements. Therefore, we will include 

these AAAHC-accredited ASCs in determining the 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 also expect that these ASCs would need to 

review their training programs and compare them to their risk assessments, emergency 

preparedness plans, policies and procedures, and communication plans. The ASCs would then 

need to make any necessary revisions to their training programs to ensure they comply with these 

requirements. 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 develop a 

comprehensive emergency training program would 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 expect that ASCs would review their emergency preparedness 

training program annually. We expect that all ASCs have a quality improvement nurse 

responsible for ensuring that the ASC is delivering quality patient care and that the ASC is 

complying with patient care regulations. We expect that the quality improvement nurse would 

be primarily responsible for the annual review of the ASC’s emergency preparedness training 

program. Thus, complying with this requirement 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 paper-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 would be exempt from the requirement for a 

community or individual, facility-based mock disaster 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, tabletop exercises, and emergency events, and revise their emergency 

plans, as needed. To comply with this requirement, ASCs would need to develop a scenario for 

each drill and exercise. ASCs would also need to develop the documentation necessary for 
 162

recording what happened during drills, exercises, 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, Standard EC.4.20, EP 1 and 12-16, p. EC-14-14a). In 

addition, the scenarios for these drills should be realistic 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 accreditation requirements do not ensure that TJCaccredited ASCs are already complying with these requirements. Therefore, the TJC-accredited 

ASCs will be included in the burden estimate. 

 The AAAHC-accredited ASCs already are required 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 requirement for a paper-based, tabletop exercise; for a 

community-based drill; or for the ASCs to maintain documentation of their drills, exercises, or 

emergency events. This AAAHC accreditation 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 expect that all of the 5,354 ASCs would be 

required to develop scenarios for a mock disaster drill and a paper-based, tabletop exercise and 

the documentation necessary to record and analyze these events, as well as any emergency 

events. Although we believe many ASCs may have developed scenarios and documentation for 
 163

whatever type of drills or exercises they had previously performed, we expect all ASCs would 

need to ensure that the testing of their emergency preparedness plans comply with these 

requirements. Based upon our experience with ASCs, 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 ASC 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 HOURS AND COST ESTIMATES FOR ALL 5,354 ASCs TO 

COMPLY WITH THE ICRs CONTAINED 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 Participation: Emergency Preparedness (§ 418.113)

 Proposed § 418.113(a) would require hospices to develop and maintain an emergency 

preparedness plan that must be reviewed and updated at least annually. We propose that the plan 

meet the criteria listed in proposed § 418.113(a)(1) through (4). 

 Although proposed § 418.113(a) is entitled "Emergency Plan" and the requirement for 

the plan is stated first, the emergency plan must include and be based upon a risk assessment. 

Therefore, since hospices must perform their risk assessments before beginning, or at least 

before they complete, their plans, we will discuss the burden related to performing the risk 

assessment first. 

 Proposed § 113(a)(1) would require 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 its physical location, the 

geographic area in which it is located, and its patient population. 

 The burden associated with this requirement would be the time and effort necessary to 

perform a thorough risk assessment. There are 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 directly 
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(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 provide in-home care, and 

contract with other facilities to provide inpatient care. The current requirements for hospices 

contain emergency preparedness requirements for inpatient hospices only (42 CFR 418.110). 

Inpatient hospices must have "a written disaster preparedness plan in effect for managing the 

consequences of power failures, natural disasters, and other emergencies 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 preparedness plan. However, these risk assessments may not be 

documented or may not address all of the requirements 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 hospices need maximum flexibility in determining the 

best way for their facilities to accomplish this task. However, we believe that in the process of 

developing a risk assessment, health care institutions should include representatives from or 

obtain input from all of their major departments. Based on our experience with hospices, we 

expect that conducting the risk assessment would require the involvement of the hospice’s 

administrator and an interdisciplinary group (IDG). The current Hospice CoPs require every 

hospice to have an IDG that includes 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, 
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include the establishment of "policies governing the day-to-day provision of hospice care and 

services" (42 CFR 418.56(a)(2)). Thus, we believe the IDG would be involved in performing the 

risk assessment. 

 We expect that members of the IDG would attend an initial meeting; review any existing 

risk assessment; develop comments and recommendations for changes to the assessment; attend 

a follow-up meeting; perform a final review; and approve the risk assessment. We expect that 

the administrator would coordinate the meetings, perform an initial review of the current risk 

assessment, provide a critique of the risk assessment, 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 likely that the administrator would spend more time 

reviewing and working on the risk assessment than the other individuals 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 comply with this requirement at a cost of 

$589,744 ($496 estimated cost for each inpatient hospice x 1,189 inpatient hospices = $589,744 

estimated cost). 

 There are no emergency preparedness requirements in the current hospice CoPs for 

hospices that provide care to patients 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 facilities would require more time than an inpatient 

hospice to perform a risk assessment. We estimate that each hospice that provides care to 
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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 hours (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, hospices would have to develop and maintain 

emergency preparedness plans that they would have 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 consequences of power failures, natural disasters, 

and other emergencies that would affect the 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 identified by the risk assessment. Further, their plans may not include 

strategies for addressing likely emergency 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 to 
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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, develop 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. Based upon our experience with inpatient hospices, we 

expect that these activities would require the involvement of the hospice’s administrator and an 

IDG, that is, a physician, registered nurse, social worker, and counselor. 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 meeting, review relevant 

sections of the facility’s current emergency preparedness or disaster plan(s), develop comments 

and recommendations for changes to the facility’s plan, attend a follow-up meeting, perform a 

final review, and approve the emergency plan. We expect that the administrator would probably 

coordinate the meetings, perform an initial review of the current emergency plan, provide a 

critique of the emergency plan, offer suggested revisions, coordinate comments, develop the new 

emergency plan, and ensure that the necessary parties approve the new emergency plan. We 

expect the administrator would 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 emergency preparedness plan at a cost of $742. Based 

on this estimate, it would require 16,646 burden hours (14 burden hours for each inpatient 

hospice x 1,189 inpatient hospices = 16,646 burden hours) for all inpatient hospices to complete 
 169

their plans at a cost of $882,238 ($742 estimated cost for each inpatient hospice x 1,189 inpatient 

hospices = $882,238 estimated cost). 

 As discussed earlier, we have no current regulatory requirement for hospices that provide 

care to patients in their homes to have emergency preparedness plans. However, it is standard 

practice for health care providers to plan for common emergencies, such as fires, power outages, 

and storms. Although we expect that these hospices 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 individuals 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 care 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 estimate 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 burden 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 burden hours at a cost of 

$3,585,102. 

 Hospices would also be required to review and update their emergency preparedness 

plans at least annually. The current hospice CoPs require inpatient hospices to periodically 

review and rehearse their disaster preparedness plan with their staff, including non-employee 
 170

staff (42 CFR 418.110(c)(1)(ii)). For purposes of this burden estimate, we would expect that 

under this proposed rule, inpatient hospices would review their emergency plans prior to 

reviewing them with all of their employees and that this 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 include ensuring that all of the hospice’s plans are up-to-date and 

in compliance with relevant federal, state, and 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 and procedures. 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). Thus, we will not 

include this activity in the burden analysis. 

 Proposed § 418.113(b) would require each hospice 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 section, and the communication plan 

at paragraph (c) of this section. It would also require hospices 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 emergency preparedness policies and procedures 

because the current hospice CoPs for inpatient hospices already require them to have "a written 

disaster preparedness plan in effect for managing the consequences of power failures, natural 

disasters, and other emergencies that would affect the hospice’s ability to provide care" (42 CFR 

418.110(c)(1)(ii)). In addition, the responsibilities for at least one of a hospice’s IDGs, if they 
 171

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)). However, we also expect that all inpatient 

hospices would need to review their current policies and procedures, assess whether they contain 

everything required by their facilities’ emergency 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 ensure they comply with these 

requirements. Since at least one of a hospice’s IDGs would be responsible for developing 

policies that govern the daily care and services for hospice patients (42 CFR 418.56(a)(2)), we 

expect that an IDG would be involved with reviewing and revising a hospice’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 requirements for hospices that provide care to 

patients in their homes to have emergency preparedness policies and procedures, it is standard 

practice for health care organizations to prepare for common emergencies, such as fires, power 

outages, and storms. We expect that these hospices already have some emergency preparedness 

policies and procedures. However, under this proposed rule, the IDG for these hospices would 

need to accomplish the same tasks as described earlier for inpatient hospices to ensure that these 

policies and procedures comply with the proposed requirements. 
 172

 We estimate that each hospice’s compliance with this requirement would require 

9 burden hours at a cost of $454. Therefore, based on that estimate, all 2,584 hospices’ that 

provide care to patients in their homes to comply with this requirement 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 emergency 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 plans at least annually. The communication plan 

would have to include the requirements listed at § 418.113(c)(1) through (7). 

 We believe that all hospices already have some type of emergency preparedness 

communication plan. Although only inpatient hospices have a current requirement for disaster 

preparedness (42 CFR 418.110(c)), it is standard practice for health care organizations to 

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

of communications in case there is an interruption in phone service to the organization (for 

example, cell phones); and a method for sharing information and medical documentation with 

other health care providers to ensure continuity of care for their patients. However, many 

hospices, both inpatient hospices and 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 some cases, develop new sections for their plans 
 173

to ensure that those plans include all of the 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 emergency communication plan complied with these 

requirements. Based upon our experience with hospices, 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 requirement would require 3 burden hours at a cost 

of $165. Therefore, based on that estimate, compliance with this requirement for all 3,773 

hospices would require 11,319 burden hours (3 burden hours for each hospice x 3,773 hospices = 

11,319 burden hours) at a cost of $622,545 ($165 estimated 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 annually. We believe that all hospices already review their 

emergency preparedness communication plans periodically. Thus, compliance with this 

requirement would constitute a usual and customary 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 program 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 demonstrate knowledge of their emergency procedures. 

Thereafter, the hospice would have to provide emergency preparedness training at least annually. 
 174

Hospices would also be required to periodically review and rehearse their emergency 

preparedness plans with their employees, with special emphasis placed on carrying out the 

procedures necessary to protect patients and others. 

 Under current regulations, all hospices are required to provide 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 orientation and training consistent with hospice 

industry standards (42 CFR 418.78(a)). In addition, inpatient hospices must periodically review 

and rehearse their disaster preparedness plans with their staff, including non-employee staff (42 

CFR 418.110(c)(1)(ii)). We expect that all hospices already provide training 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 training programs and compare their 

contents to their updated emergency preparedness 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 that they complied with these requirements. 

 The burden associated with the aforementioned requirements would be the time and 

effort necessary for a hospice to bring itself into 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 registered nurse would compare the hospice’s current 

training program with the facility’s emergency preparedness plan, policies 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 hospices = 22,638 burden hours) at a cost of 
 175

$950,796 ($252 estimated cost for each hospice x 3,773 hospices = $950,796 estimated cost). 

 We are proposing that hospices also be required to review and update their emergency 

preparedness training programs at least annually. We believe that hospices already review their 

emergency preparedness training programs periodically. Therefore, compliance with this 

requirement would constitute a usual and customary 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 hospices to participate in a community mock 

disaster drill, and if one were not available, conduct an individual, facility-based mock disaster 

drill, and a paper-based, tabletop exercise at least annually. Hospices would also be required to 

analyze their responses to and maintain documentation 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 scenarios for their drills and exercises. A hospice 

also would have to develop the required documentation. 

 Hospices would also have to periodically review and rehearse their emergency 

preparedness plans with their staff (including nonemployee staff), with special emphasis on 

carrying out the procedures necessary to protect patients and others (§ 418.110(c)(1)(ii)). 

However, this periodic rehearsal requirement does not ensure that hospices are performing any 

type of drill or exercise annually or that they are documenting their responses. In addition, there 

is no requirement in the current CoPs for outpatient 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 exercises and the documentation necessary to record 

the events during drills, exercises, and emergency events would be new requirements for all 

hospices. 
 176

 The associated burden would be the time and effort necessary for a hospice to comply 

with these requirements. We expect that complying with these requirements 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 hospices = 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 all of the requirements in § 418.113, it would 

require an estimated 193,041 burden 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 require Psychiatric Residential Treatment Facilities 

(PRTFs) to develop and maintain emergency preparedness 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 assessment 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 emergencies 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 comply with all of our proposed requirements. 

Therefore, we expect that all PRTFs would have 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 departments. Based on our experience with PRTFs, 

we expect that conducting the risk assessment would require the involvement of the PRTF’s 

administrator, a psychiatric registered nurse, and a clinical social worker. We expect that all of 

these individuals would attend an initial meeting, review their 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 psychiatric registered nurse 
 178

would coordinate the meetings, perform an initial review, offer suggested revisions, coordinate 

comments, develop a new risk assessment, and ensure that the necessary parties approve the new 

risk assessment. We also expect that the psychiatric 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 require 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 preparedness 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, develop new sections to complete its emergency 

preparedness plan. 

 Based upon our experience with PRTFs, we expect that the administrator and psychiatric 

registered nurse who were involved in developing the risk assessment would be involved in 

developing the emergency preparedness plan. However, we expect it would require substantially 

more time to complete the plan than the risk assessment. We expect that the psychiatric nurse 

would be the most heavily involved in reviewing and developing the PRTF’s emergency 

preparedness plan. We also expect that a clinical 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 would require 12 burden hours at a cost of $634. Thus, 

we estimate that it would require 4,644 burden hours (12 burden hours for each PRTF x 387 
 179

PRTFs = 4,644 burden hours) for all 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 are already reviewing their emergency preparedness 

plans periodically. Thus, compliance with this 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 their emergency plan set forth in paragraph (a) of 

this section, the risk assessment at paragraph (a)(1) of this section, 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 address the requirements listed at § 441.184(b)(1) through (8). 

 Since we expect that all PRTFs already have some type of emergency plan, we also 

expect that all PRTFs have some emergency preparedness 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 psychiatric registered nurse would be involved in 

reviewing and revising the policies and procedures 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 this estimate, it would require 3,483 burden hours 
 180

(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 periodically. Therefore, compliance with this 

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(c) would require each PRTF to develop and maintain an emergency 

preparedness communication plan that complied with 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 set out in § 441.184(c)(1) through (7). 

 We expect that all PRTFs have some type of emergency preparedness communication 

plan. It is standard practice for health care facilities to maintain contact information for both staff 

and outside sources of assistance; 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 their residents. 

However, most PRTFs may not have formal, written emergency preparedness communication 

plans. Therefore, we expect that all PRTFs would need to review 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 administrator and a psychiatric registered nurse to 

review, revise, and if needed, develop new sections for the PRTF’s emergency preparedness 
 181

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 their emergency preparedness communication plans 

at least annually. We believe that PRTFs are already reviewing their emergency preparedness 

communication plans periodically. Thus, compliance with this 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(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 procedures 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 also have to ensure that their staff could 

demonstrate knowledge of the emergency procedures. Thereafter, the PRTF would have to 

provide emergency preparedness training at least annually. 

 Based on our experience with PRTFs, we expect 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 requirement 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 develop 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 for each PRTF x 387 PRTFs = 3,870 burden hours) 

at a cost of $178,020 ($460 estimated cost for each PRTF x 387 PRTFs = $178,020 estimated 

cost). 

 PRTFs would also be required to review and update their emergency preparedness 

training program at least annually. We believe that PRTFs are already reviewing their 

emergency preparedness training programs periodically. Therefore, compliance with this 

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(d)(2) would require PRTFs to participate in a community mock 

disaster drill, and if one were not available, conduct an individual, facility-based mock disaster 

drill, and a paper-based, tabletop exercise at least 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 needed. However, if a PRTF experienced an actual 

natural or man-made emergency that required activation of its emergency plan, that PRTF would 

be exempt from engaging in a community or an individual, facility-based mock disaster drill for 

1 year following the onset of the actual emergency 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 expect 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 appropriate documentation. Thus, we will analyze the 

burden of these requirements for all PRTFs. 

 Based on our experience with PRTFs, we expect that the same individual who developed 

the emergency preparedness training program would 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 section 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 HOURS AND COST ESTIMATES FOR ALL 387 PRTFs TO 

COMPLY WITH THE ICRs CONTAINED 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 Emergency Preparedness (§ 460.84)

 Proposed § 460.84(a) would require the Program 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) would require PACE organizations to develop documented, 

facility-based and community-based risk assessments 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 that each PACE organization should have already 

performed some sort of risk assessment. 

 Under the current regulations, PACE organizations 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, staff, or the public (§ 460.72(c)(1)). 
 185

The definition of "emergencies" includes natural disasters that are likely to occur in the PACE 

organization’s area (§ 460.72(c)(2)). PACE organizations are required 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 physical structure(s), the areas in 

which they are located, and the location(s) of their 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 review, revise, and update their current risk 

assessments. 

 We have not designated any specific process or format for PACE organizations to use in 

conducting their risk assessments because we believe that they would be able to determine the 

best way for their facilities to accomplish this task. However, we expect that they would include 

representation or input from all of their major departments. Based on our experience with PACE 

organizations, we expect that conducting the risk assessment would require the involvement of 

the PACE organization’s program director, medical 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 asked to individually review relevant 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 follow-up meeting, perform a final review, and 

ensure the new risk assessment was approved by the appropriate individuals. We expect that the 
 186

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 time reviewing and developing the risk assessment than the other 

individuals. 

 We estimate that complying with the requirement to conduct a risk assessment would 

require 14 burden hours at a cost of $761. For all 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 PACE organizations = $69,251 estimated cost). 

 After conducting a risk assessment, PACE organizations would have to develop and 

maintain emergency preparedness plans that satisfied all of the requirements in § 460.84(a)(1) 

through (4). In addition to the requirement to establish, implement, and maintain procedures for 

managing emergencies and disasters, current regulations require PACE organizations to have a 

governing body or designated person responsible for developing policies on participant health 

and safety, including a comprehensive, systemic operational 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 PACE 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 complete their emergency preparedness plans. 
 187

 Based upon our experience with PACE organizations, 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 more 

time to complete the plan. We expect that the quality improvement nurse would have primary 

responsibility for reviewing and developing the 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 the sections of the plan that 

would be relevant to their areas of responsibility. 

 We estimate that for each PACE organization 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 organizations = 2,093 burden hours) at a cost of 

$112,749 ($1,239 estimated cost for each PACE organization x 91 PACE organizations = 

$112,749 estimated cost). 

 PACE organizations would also be required to review and update their emergency 

preparedness plans at least annually. We believe that PACE organizations are already reviewing 

their emergency preparedness plans periodically. Therefore, compliance with this requirement 

would constitute a usual and customary business practice for PACE organizations 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, the risk assessment at paragraph (a)(1) of this section, and the 
 188

communication plan at (c) of this section. It would also require PACE organizations to review 

and update these policies and procedures at least annually. At a minimum, we would require that 

a PACE organization’s policies and procedures address the requirements listed at § 460.84(b)(1) 

through (9). 

 Current regulations already require that PACE organizations establish, implement, and 

maintain procedures for managing emergencies and disasters (§ 460.72(c)). The definition of 

"emergencies" includes medical and nonmedical emergencies, 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 designated person who functions as the governing 

body responsible for developing policies on participant 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 not ensure that all PACE organizations have 

policies and procedures that would comply with our proposed requirements. 

 The burden associated with the proposed requirements would be the resources needed to 

review, revise, and, if needed, develop new emergency preparedness policies and procedures. 

We expect that the program director, home care coordinator, and quality improvement nurse 

would be primarily responsible for reviewing, revising, and if needed, developing any new 

policies and procedures needed to comply with our proposed requirements. 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 hours 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 organizations = $54,418 estimated cost). 
 189

 We propose that each PACE organization must also review and update its emergency 

preparedness policies and procedures at least annually. We believe that PACE organizations are 

already reviewing their emergency preparedness 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 § 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 review and update this plan at least annually. The 

communication plan must include the information 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) that is responsible for developing policies on participant health 

and safety, including a comprehensive, systemic operational plan to ensure the health and safety 

of the PACE organization’s participants (§ 460.62(a)(6)). We expect that the PACE 

organizations’ comprehensive, systemic operational plans would include at least some of our 

proposed requirements. In addition, 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 facility; and a method for 

sharing information and medical documentation with other health care providers to ensure 

continuity of care for patients. Thus, we expect that all PACE organizations 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 organizations, we expect that the home care 

coordinator and the quality assurance nurse would be primarily 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 proposed 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 would require 637 burden hours (7 burden hours for each PACE 

organization x 91 PACE organizations = 637 burden 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 review and update its emergency preparedness 

communication plan at least annually. We believe that PACE organizations are already 

reviewing and updating their emergency preparedness communication plans periodically. Thus, 

compliance with this requirement would constitute a usual and customary business practice for 

PACE organizations and would not be subject to the PRA in accordance with 5 CFR 

1320.3(b)(2). 

 Proposed § 460.84(d) would require PACE organizations 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 have to meet the requirements 

listed at § 460.84(d)(1) and (2). 

 Proposed § 460.84(d)(1) would require PACE organizations to provide initial training on 

their emergency preparedness policies and procedures to all new and existing staff, individuals 

providing on-site services under arrangement, contractors, participants, and volunteers, 

consistent with their expected roles and maintain documentation of this training. PACE 

organizations would also have to ensure that their staff could demonstrate knowledge of the 
 191

emergency procedures. Thereafter, PACE organizations would be required to provide this 

training annually. 

 Current regulations require PACE organizations to provide periodic orientation and 

appropriate training to their staffs and participants in emergency 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, and communication plan. The PACE organization 

would also need to revise and, in some cases, develop new sections to ensure that its emergency 

preparedness training program complied with our proposed requirements. We expect that the 

quality assurance nurse would review all elements of the PACE organization’s training program 

and determine what tasks would need to be performed and what materials would need to be 

developed to comply with our proposed requirements. 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 burden hours at a cost of $540. Therefore, 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 with this requirement at a cost of $49,140 ($540 

estimated cost for each PACE organization x 91 PACE organizations = $49,140 estimated cost). 

 PACE organizations would also be required to review and update their emergency 

preparedness training program at least annually. We believe that PACE organizations are 

already reviewing and updating their emergency preparedness training programs periodically. 

Therefore, compliance with this requirement would constitute a usual and customary business 
 192

practice for PACE organizations and would not be subject to the 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, tabletop exercise at least 

annually. PACE organizations would also be required to analyze their responses to, and 

maintain documentation of, all drills, exercises, and any emergency events they experienced. If a 

PACE organization experienced an actual natural 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 following the onset of the actual event. 

To comply with these requirements, PACE organizations would need to develop a specific 

scenario for each drill and exercise. The PACE organizations would also have to develop the 

documentation necessary for recording and analyzing their response to all drills, exercises, and 

emergency events. 

 Current regulations require each PACE organization to conduct a test of its emergency 

and disaster plan at least annually (42 CFR 460.72(c)(5)). They also must evaluate and 

document the effectiveness of their emergency and disaster plans. Thus, PACE organizations 

already conduct at least one test annually 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 proposed requirement for conducting a paper-
 193

based, tabletop exercise; performing a community-based 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 the documentation necessary to record and analyze 

their response to all drills, exercises, 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 activity 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 hours (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 organizations = $20,475 estimated cost). 

TABLE 6: BURDEN HOURS AND COST 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 6,643 334,698 
 194

**The hourly labor cost is blended between the wages for multiple staffing levels. 

H. ICRs Regarding Condition of Participation: 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 and 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 accredited and non-accredited, 

from the CMS CASPER data system, which are 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 hospitals shown may not equal the number of hospitals 

at the time of this proposed rule’s publication. In addition, some hospitals may have chosen to 

be accredited by more than one accrediting organization. 

 There are approximately 4,928 Medicare-certified hospitals. This includes 107 critical 

access hospitals (CAHs) that have rehabilitation or psychiatric distinct part units (DPUs) as of 

March 27, 2013. The services provided by CAH psychiatric or rehabilitation DPUs must comply 

with the hospital Conditions of Participation (CoPs) (42 CFR 485.647(a)). RNHCIs and CAHs 

that do not have DPUs have been excluded from this number and are addressed separately in this 

analysis. Of the 4,928 hospitals reported in CMS’ CASPER data 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 Organizations (JCAHO), the AOA, and DNVHC. 

 Accreditation can substantially affect the burden a hospital would sustain under this 

proposed rule. The Joint Commission accredits 3,410 hospitals. Many of our proposed 

requirements are similar or virtually identical to the standards, rationales, and elements of 
 195

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 organizations, AOA and DNVHC, accredit 185 and 176 

hospitals, respectively. The AOA hospital accreditation 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 indicated 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-accredited hospitals = 1,518 non TJC-accredited 

hospitals). 

 We have used TJC’s "Comprehensive Accreditation Manual for Hospitals: The Official 

Handbook 2008 (CAMH)" to determine the burden for TJC-accredited hospitals. In the chapter 

entitled, "Management of the Environment of Care" (EC), hospitals are required to plan for 

managing the consequences of emergencies (CAMH, Standard EC.4.11, CAMH Refreshed Core, 

January 2008, p. EC-13a). Individual standards 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 vulnerability 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 services. A TJC-accredited hospital also must determine the 

likeliness of the identified risks occurring, as well as their consequences. Thus, we expect that 
 196

TJC-accredited hospitals already conduct an HVA that complies with our proposed requirements 

and that any additional tasks necessary to comply 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 the 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, utilizing an all-hazards approach. We expect that 

most non TJC-accredited hospitals have already performed at least some of the work needed for 

a risk assessment. The Niska and Burt article indicated 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 facilities director, the health information services director, the 

safety director, the security manager, the community relations manager, the food services 

director, and administrative support staff. We expect 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 director, attend a follow-up meeting, perform a final 

review, and approve the new risk assessment. 
 197

 We expect that the risk management director would coordinate the meetings, review and 

comment on 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 

hospital administrator would spend 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 hospital. There are approximately 1,518 non 

TJC-accredited hospitals. Therefore, it would require an estimated 54,648 burden hours (36 

burden hours for each non TJC-accredited hospitals x 1,518 non TJC-accredited hospitals = 

54,648 burden hours) for all non TJC-accredited hospitals 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 require 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 and 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" approach to coordinating six critical areas: 

communications, resources and assets, safety and security, staff roles and responsibilities, 

utilities, and patient clinical and support activities during emergencies (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 strategies and actions to be activated during the 

emergency" and "[r]ecovery strategies and actions designed to help restore the systems that are 
 198

critical to resuming normal care, treatment and 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, including patients who are pediatric, geriatric, 

disabled or have serious chronic conditions or addictions" (CAMH, Standard EC.4.18, EP 2, p. 

EC-13g). Hospitals also must plan how to manage 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 believe that the burden would be negligible. 

Therefore, for TJC-accredited hospitals, 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). 

 We expect that most, if not all, non TJC-accredited 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 hospitals must already meet the requirements set out at 42 CFR 

482.41, including emergency power, lighting, gas and 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 compare 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 that it would require substantially more time to 
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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 TJC-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 TJC-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. Therefore, compliance with this requirement would 

constitute a usual and customary business practice for hospitals and 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, the 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 procedures at least annually. At a minimum, we would require that 

the policies and procedures address the requirements at § 482.15(b)(1) through (8). 

 We would expect all hospitals to review their emergency preparedness policies and 

procedures and compare them to their emergency 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 procedures that guide and support patient care, treatment, and 

services" (CAMH, Standard LC.3.90, EP 1, CAMH Refreshed Core, January 2008, p. LD-15). 

Thus, we expect that TJC-accredited hospitals already have some policies and procedures related 

to our proposed requirements. As discussed later, many of the requirements in proposed 

§ 482.15(b) has a corresponding requirement in the TJC 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 generators 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 electricity, water, fuel, and other essential utility needs in cases 

when their usual supply is disrupted or compromised (CAMH, Standard EC.4.17, EPs 1-5, p. 

EC-13f). Thus, we expect that TJC-accredited hospitals would be in compliance with our 

proposed provision of subsistence requirements 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 communicating 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 make 
 201

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 equipment, to alternative care sites (ACSs) when 

the hospital cannot provide care, treatment, and services in their 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 (CAMH, 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 these requirements would ensure compliance with 

the proposed requirement that the hospital establish 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, staff, 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 hospitals would be in compliance 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 documentation that preserves patient information, protects the 

confidentiality of patient information, and ensures that records are secure and readily available. 

The CAMH chapter entitled "Management of Information" requires TJC-accredited hospitals to 

have storage and retrieval systems for their clinical/service and hospital-specific information 
 202

(CAMH, Standard IM.3.10, EP 5, CAMH Refreshed Core, January 2008, p. IM-10) and to 

ensure the continuity of their critical information "needs for patient care, treatment, and services 

(CAMH, Standard IM.2.30, Rationale for IM.2.30, 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 patients’ clinical information, including 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 hospitals 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-accredited 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 grant disaster privileges to volunteers that are 

eligible to be licensed independent practitioners" (CAMH, Standard MS.4.110, CAMH 

Refreshed Care, January 2008, p. MS-27). Finally, in the chapter entitled "Management of 

Human Resources" (HR), hospitals "may assign disaster responsibilities 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 not 
 203

believe these requirements would ensure compliance 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 hospitals must plan for the sharing of resources and 

assets with other health care organizations (CAMH, Standard EC.4.14, EPs 7 and 8, p. EC-13d). 

However, we would not expect TJC-accredited hospitals 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 waiver of some federal rules 

pursuant to §1135 of the Social Security 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 support 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 developed 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 that any modifications that TJCaccredited hospitals would need to make to comply with the remaining proposed requirements 
 204

would not impose a burden above that incurred as part of usual and customary business practices. 

Thus, with the exception of the proposed requirements set out at § 482.15(b)(3), (b)(6), and 

(b)(7), the proposed requirements would constitute 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 written policies and procedures that comply with the proposed 

requirements. We expect that the risk management 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 representatives 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 then need to compile and disseminate these new 

policies and procedures. 

 We estimate that complying with these requirements 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 for each TJC-accredited 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 policies and procedures accurately reflect their risk assessments, 

emergency preparedness plans, and communication 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 current policies and procedures, 
 205

suggest revisions, coordinate comments, develop the policies and procedures, and ensure that the 

necessary parties approve it. We expect that the hospital administrator would spend more time 

reviewing the policies 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 cost of $2,623. Based on this estimate, for all 

1,518 non TJC-accredited hospitals to comply with 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 would be a burden as a result of proposed 

§ 482.15(b)(7). Proposed § 482.15(b)(7) would require hospitals to develop and maintain 

policies and procedures that address a hospital’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 hospital 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 developing the written agreements 

related to those arrangements. 

 All 4,928 hospitals would need to identify other hospitals and other providers with which 

they could have agreements, negotiate and draft the agreements, and obtain all necessary 

authorizations for the agreements. For the purpose of determining the burden, we will assume 

that hospitals would have written agreements with two other hospitals and other providers. Based 

on our experience with hospitals, we expect that complying with this requirement would 
 206

primarily require the involvement of the hospital’s administrator and risk management director. 

We also expect that a hospital attorney would assist 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 burden 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 hospitals to be in compliance with all of the 

requirements in § 482.15(b) it would require 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 least annually. We believe hospitals are already 

reviewing and updating their emergency preparedness policies and procedures periodically. 

Thus, compliance with this requirement would constitute a usual and customary business 

practice for both TJC-accredited and non TJC-accredited 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 hospital 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 annually. 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 health care facilities to maintain contact information for staff 

and outside sources of assistance; have alternate means of communication in case there is an 

interruption in phone service to the facility; and have a method for sharing information and 

medical documentation with other health care providers to ensure continuity 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 required 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 staff, external authorities, 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 circumstances and plans for communicating information about patients 

to third parties (such as other health care organizations) . . ." (CAMH, Standard EC.4.13, EP 12, 

p. EC-13c). Thus, we expect that that TJC-accredited hospitals would be in compliance with 

proposed § 482.15(c)(1) through (c)(4). In addition, the rationale for EC.4.13 states, "the 

hospital maintains reliable surveillance and communications 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 emergency communication plans that would satisfy the requirements 

contained in proposed § 482.15(c). Therefore, compliance with this requirement would 
 208

constitute a usual and customary business practice and would not be subject to PRA in 

accordance with 5 CFR 1320.3(b)(2). 

 Most, if not all, non TJC-accredited hospitals would be substantially in compliance with 

proposed § 482.15(c)(1) through (c)(4). Nevertheless, 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 all of the proposed requirements in this subsection. 

We expect that this activity would require the involvement of the hospital’s administrator, the 

risk management director, the facilities director, the health information services director, the 

security manager, and administrative support staff. We estimate that complying with this 

requirement would require 10 burden hours at a 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 hospitals to review and update their emergency 

preparedness communication plans at least annually. We believe that hospitals are already 

reviewing and updating their emergency preparedness communication plans periodically. 

Therefore, 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 § 482.15(d) would require hospitals to develop and maintain emergency 

preparedness training and testing programs and review 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 and procedures to all and new existing staff, 

individuals providing services under arrangement, and volunteers, consistent 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 initial and annual training. 

We expect that all hospitals would review their current training programs and compare them to 

their risk assessments, emergency plans, policies and procedures, and communication plans as 

set forth in § 482.15(a)(1), (a), (b), and (c), respectively. Hospitals would need to revise and, if 

necessary, develop new sections or material to ensure that their training programs comply with 

our proposed requirements. 

 The TJC-accredited hospitals are required to define staff roles and responsibilities in their 

EOP and train their staff for their assigned roles during emergencies (CAMH, EC.4.16, EPs 1-2, 

p. EC-13e). In addition, the TJC-accredited hospitals are required to provide an initial 

orientation, which includes information that the 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 initial training. TJC-accredited 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), and we expect that 

emergency preparedness is part of such on-going training. 

 Although TJC requirements do not specifically address training for individuals providing 

services under arrangement or training for volunteers consistent with their expected roles, it is 
 210

standard practice for health care facilities to provide some type of training 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 proposed requirements 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 non TJCaccredited hospitals have some type of emergency preparedness training program and provide 

training to their staff regarding their duties and responsibilities under their emergency plans. 

However, under this proposed rule, non TJC-accredited hospitals would need to compare their 

existing training programs with their risk assessments, emergency preparedness plans, policies 

and procedures, and communication plans. They also would need to revise, update, and, if 

necessary, develop new sections and new material for their training programs. 

 To develop their training programs, hospitals could draw upon the resources of federal, 

state, and local emergency preparedness agencies, as well as state and national health care 

associations and organizations. In addition, hospitals could develop partnerships with other 

hospitals and health care facilities to develop the necessary training. Some hospitals might also 

choose to purchase off-the-shelf emergency training 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 would use their own staff. 

 Based on our experience with hospitals, we expect that complying with this requirement 

would require the involvement of the hospital administrator, the risk management director, a 

health care trainer, and administrative support staff. We estimate that it would require 40 burden 

hours for each hospital to develop an emergency preparedness training program at a cost of 
 211

$2,094 for each non TJC-accredited hospital. We estimate that it would require 60,720 burden 

hours (40 burden hours for each non TJC-accredited 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 training 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 maintain documentation of their training. Based on 

our experience, we believe it is standard practice for hospitals to document the training they 

provide to their staff, individuals providing services under arrangement, and volunteers. 

Therefore, compliance with this requirement would 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 also require hospitals to participate in a community mock 

disaster drill and a paper-based, tabletop exercise 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 required to analyze their responses to, and maintain 

documentation of, all drills, exercises, and emergency events. If a hospital experienced an actual 

emergency which required activation of its emergency plan, it would be exempt from the 

requirement for a community or individual, 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 these 
 212

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 develop a scenario for that drill. 

However, for the purpose of determining the burden, 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, TJC-accredited hospitals must analyze all drills 

and exercises, identify deficiencies and areas for improvement, and modify their EOPs in 

response to the analysis of those tests (CAMH, Standard EC.4.20, EPs 15-17, p. EC-14b). 

Therefore, we expect that TJC-accredited hospitals 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 develop 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 preparedness training program and 

that most, if not all, of them already conduct some type of drill or exercise 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 these 
 213

hospitals have already developed the required documentation for recording the events, and 

analyzing their responses to, their drills, exercises, 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 required to develop scenarios for a drill and 

an exercise and the documentation necessary to record and analyze their 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 the accompanying documentation. We expect that 

the health care trainer would spend more time 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 AND COST ESTIMATES FOR ALL 4,928 

HOSPITALS TO COMPLY WITH THE ICRs 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 4,852,430 
 214

§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 transplant centers to have policies and procedures that 

address emergency preparedness. Proposed § 482.78(a) would require transplant centers or the 

hospitals in which they operate to have an agreement with at least one other Medicare-approved 

transplant center to provide transplantation services and related 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 types of services that would be provided 

during an emergency. 

 "Transplantation services and related care" would include all of a center’s transplantrelated activities, ranging from the evaluation of potential transplant recipients and living donors 

through post-operative care of transplant recipients and living donors. If the agreement does not 

include all services normally provided by the receiving transplant center, the agreement should 

state precisely what services the receiving transplant center would provide during an emergency. 

 We would also expect each transplant center 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 center could not provide its 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 for this requirement, we expect that each 

transplant center would develop 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 transplant center medical 

director, the clinical transplant coordinator, and a hospital attorney. We believe the clinical 

transplant coordinator would be primarily responsible for initially identifying what types of 

services the center’s patients would need to have provided by another transplant center during an 

emergency, as well as which transplant center(s) could 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 the transplant center(s) to contact. The hospital 

attorney would be primarily responsible for drafting an agreement with input from the transplant 

center medical director. We estimate that it would require 15 burden hours for each transplant 

center to develop an agreement with another transplant center to provide services for its patients 

and living donors during an emergency, if applicable, at a cost of $1,388. 

 According to CMS’ Center for Medicaid, Children’s Health Insurance Program (CHIP), 

and Survey and Certification (CMCS), there are currently 770 transplant programs or transplant 

centers. CMS uses the terms transplant centers and transplant programs interchangeably 

(70 FR 6145 and 72 FR 15210). Therefore, based on the 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 transplant center x 770 transplant centers = 11,550 burden hours) at a 
 216

cost of $1,068,760 ($1,388 estimated cost for each transplant center x 770 transplant centers = 

$1,068,760 estimated cost). 

 Proposed § 482.78(b) would require a transplant center to ensure that the written 

agreement between the hospital in which it is located and the hospital’s designated OPO as 

required under § 482.100 addresses the duties and responsibilities of the hospital and the OPO 

during an emergency. We expect that transplant 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 the duties and responsibilities of the hospital 

and OPO during an emergency are addressed in the agreement would be the resources needed to 

draft, review, revise, and approve the language. Based on our experience with transplant centers, 

we expect that accomplishing these tasks would require the involvement of an administrator, the 

transplant center medical director, the clinical transplant coordinator, and a hospital attorney. 

We expect that the medical director and the clinical transplant coordinator would be primarily 

responsible for drafting, reviewing, revising, and approving the language of the agreement. A 

hospital attorney would be primarily responsible for drafting and reviewing any proposed 

language before the agreement was approved. The attorney would also brief the administrator 

and the administrator would approve the language. Thus, we estimate that it would require 

15 burden hours for each transplant center to comply with the requirement 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 hospitals 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 would require 3,570 burden hours 
 217

(15 burden hours for each hospital x 238 hospitals= 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 HOURS AND COST ESTIMATES 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 preparedness requirements for long term care 

(LTC) facilities. LTC facilities 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 their emergency preparedness plan set forth in 

paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this section, and the 

communication plan that is required in paragraph (c) of this section (§ 483.73(b)). Proposed 

§ 483.73(d) would require LTC facilities 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 cover skilled nursing facilities (SNFs) and 

nursing facilities (NFs), respectively, of the Omnibus Budget Reconciliation Act of 1987 (OBRA 

'87) provide for a waiver of Paperwork Reduction 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 administered in a manner that enables it to use its 

resources effectively and efficiently to attain or maintain the highest 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 requirement 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 preparedness. We believe 

this waiver still applies to those revisions we have proposed to existing requirements in part 483 

subpart B. Thus, the ICRs for the proposed requirements in § 483.73 are not subject to the PRA. 

K. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 483.475)

 Proposed § 483.475(a) would require Intermediate Care Facilities for Individuals with 

Intellectual Disabilities (ICF/IID) to develop and maintain an emergency preparedness plan that 

would have to be reviewed and updated at least annually. We propose that the plan would 

include the elements set out at § 483.475(a)(1) through (4). We will discuss the burden for these 

activities individually beginning with the risk assessment. 

 Proposed § 483.475(a)(1) would require each ICFs/IID to develop a documented, facilitybased and community-based risk assessment utilizing an all-hazard approach, including missing 

clients. We expect an ICF/IID to identify the medical and non-medical emergency events it 
 219

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 the 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 CoPs 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 written plans and procedures, we expect that all 

ICFs/IID have already performed some type of risk 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 that are within the facility or in the facility’s local area. We 

do not expect that this requirement would be sufficient to protect the health and safety of clients 

during more widespread local, state, or national emergencies. In addition, an ICF/IID current 

risk assessment may not address all of the elements required in proposed § 483.475(a). 

Therefore, all ICFs/IID would have to conduct a thorough review 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 ICFs/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 include representatives from, or 

obtain input from, all of the major departments in their facilities. Based on our experience with 
 220

ICFs/IID, we expect that conducting the risk assessment 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 meeting, review relevant sections of the current 

assessment, develop comments and recommendations for changes to the assessment, attend a 

follow-up meeting, perform a final review, and approve the risk assessment. We expect that the 

administrator would coordinate the meetings, perform an initial review of the current risk 

assessment, critique the risk assessment, offer suggested revisions, coordinate comments, 

develop the new risk assessment, and assure that the necessary parties approve the new risk 

assessment. We also expect that the administrator would spend more time reviewing and 

working on the risk assessment. Thus, we estimate that complying with this requirement would 

require 10 burden hours to complete at a cost 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 would be required to develop emergency 

preparedness plans that addressed the emergency events that could affect not only their facilities 

but also the communities in which they are located. An ICF/IID current disaster plan might not 

address all of the medical and non-medical emergency events identified by its risk assessment, 

include strategies for addressing those emergency events, or address 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 risk 
 221

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 existing emergency plan. Based upon our experience 

with ICFs/IID, we expect that the same individuals 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 requirements in this section. Based on this estimate, it 

would require 57,978 burden hours (9 burden hours 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 review and update its emergency preparedness 

plan at least annually. We believe that ICFs/IID already review their emergency preparedness 

plans 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(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 section, 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 address the requirements listed at § 483.475(b)(1) through (8). 
 222

 We expect all ICFs/IID to compare their current emergency preparedness policies and 

procedures to their emergency preparedness plans, risk assessments, and communication plans. 

They would then need to revise and, if necessary, 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 already have procedures that comply with some of the other proposed 

requirements in this section. For example, as will be discussed later, current regulations require 

ICFs/IID to perform drills, evaluate the effectiveness 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 emergency 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 revise, and, if needed, develop new policies and procedures. 

 The burden incurred by reviewing, revising, updating and, if necessary, 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 comply would require 9 burden hours at a cost of $525. Based on this 

estimate, for all 6,442 ICFs/IID to comply with 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 of 
 223

$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 update their emergency preparedness policies and 

procedures at least annually. We believe that ICFs/IID already review 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 ICF/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 review and update the plan at least 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 the 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 comply with the proposed requirements 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 disaster plans and procedures for all 

potential emergencies (§ 483.470(h)(1)). We expect that an integral part of these plans and 

procedures would include communication. Further, it is standard practice for health care 

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

have alternate means of communication in case there is an interruption in phone service to the 

facility (for example, cell phones); and have a method for sharing 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 emergency 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 require 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 ICFs/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 annually. We believe that ICFs/IID already review their plans, 

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(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 meet 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 preparedness policies and procedures to all new and existing staff, 
 225

individuals providing services under arrangement, and volunteers, consistent with their expected 

roles, and maintain documentation of the training. Thereafter, the ICF/IID would have to 

provide emergency preparedness training at least annually. 

 The ICFs/IID would need to compare their current emergency preparedness training 

programs’ contents to their risk assessments and updated emergency preparedness plans, policies 

and procedures, and communication plans and then 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 periodically review and provide 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 are assigned for evacuations (§ 483.470(i)(1)(i)). We 

expect that all ICFs/IID have emergency preparedness training programs for their staff. 

However, under this proposed rule, each ICF/IID would need to review its current training 

program and compare its contents to its updated emergency preparedness plan, policies and 

procedures, and communications plan. Each ICF/IID also would need to revise and, if necessary, 

develop new sections for their training program 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 nurse would be primarily involved in reviewing the 

ICF/IID current training program and the ICF/IID updated emergency preparedness plan, 

policies and procedures, and communication plan; determining what tasks would need to be 

performed to comply with the proposed requirements 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 require 
 226

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 with 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 update their emergency preparedness training 

program at least annually. We believe that ICFs/IID already review their emergency 

preparedness training 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). 

 Proposed § 483.475(d)(2) would require ICFs/IID to participate in a community mock 

disaster drill and a paper-based, tabletop exercise at least annually. The ICFs/IID would also be 

required to analyze their responses to and maintain documentation of all drills, tabletop 

exercises, and emergency events, and revise their emergency plans, as needed. If an ICF/IID 

experienced an actual natural or man-made emergency that required activation of its emergency 

plan, the ICF/IID would be exempt from engaging in a community or individual, 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 develop scenarios for each drill and exercise. An 

ICF/IID also would have to develop 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 must "actually evacuate 

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, including accidents, and 
 227

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 drill or table top exercise. For the purpose of 

determining a burden for these requirements, all ICFs/IID would have to develop scenarios, one 

for the drill and one for the table top exercise, and all ICFs/IID would have to develop the 

necessary documentation. 

 The burden associated with these requirements would be the resources the ICF/IID would 

need to comply with the proposed requirements. We expect that complying with these 

requirements would likely require the involvement of a registered nurse. We expect that the 

registered nurse would develop the required documentation. We also expect that the registered 

nurse would develop the scenarios for the drill and exercise. We estimate that these tasks would 

require 4 burden hours at a cost of $188. Based 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 CONTAINED 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 2,338,446 
 228

§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 Participation: Emergency Preparedness (§ 484.22)

 Proposed § 484.22(a) would require home health 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 the plan meet the requirements 

listed at § 484.22(a)(1) through (4). We will discuss the burden for these activities individually, 

beginning with the risk assessment. 

 Accreditation may substantially affect the burden a HHA would experience under this 

proposed rule. HHAs are accredited by three different accrediting organizations (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 standards for CHAP nor the ones for ACHC appeared to 

ensure substantial compliance with our proposed requirements in this rule. Therefore, the HHAs 

accredited by CHAP and ACHC will 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-accredited 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 significant factor in determining the burden, we will 

analyze the burden for the 1,734 TJC-accredited 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 system, which is updated periodically by the 
 229

individual states. Due to variations 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 require that HHAs develop a documented, facility-based and 

community-based risk assessment utilizing an all-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 events 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 and 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 Manual 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 "evaluate the potential adverse 

impact of the external environment and the services 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 whenever it identifies any new external risk 

factors or begins a new service (CAMHC, Standard EC.2.10, p. EC-7). Moreover, TJCaccredited HHAs are required to develop and maintain "a written emergency management plan 

describing the process for disaster readiness 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 . . . activities related to care, treatment, and services (for example, 

scheduling, modifying, or discontinuing services; controlling 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 accreditation requirements has 

already conducted a risk assessment that would satisfy our proposed requirements. Any tasks 

needed to comply with our proposed requirements would not result in any additional burden. 

Thus, for the 1,734 TJC-accredited HHAs, the risk assessment 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). 

 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 risk assessments are unlikely to satisfy all of our 

proposed requirements. Therefore, we will analyze the burden for the 10,615 non TJCaccredited HHAs to comply. 

 We have not designated any specific process 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 HHA 
 231

administrator, the director of nursing, director of rehabilitation, and the office manager. We 

expect that these individuals would attend an initial meeting, review relevant sections of the 

current assessment, prepare and forward their comments 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 nursing 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 facility’s new risk assessment than the other 

individuals. We estimate that the risk assessment 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 burden 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 emergency preparedness plan that would satisfy 

most of our proposed requirements. Although the current HHA CoPs require that there be a 

qualified person who "is authorized in writing to act in the absence of the administrator" 

(§ 484.14(c)), the TJC standards do not specifically address delegations of authority or 

succession plans. Furthermore, TJC standards do not address persons-at-risk. Therefore, we 
 232

expect that the 1,734 TJC-accredited 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 delegations of authority and 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 need to update, revise, and, in some cases, develop 

new sections for their emergency plans. 

 Based on our experience with HHAs, we expect that the same individuals who were 

involved in the risk assessment would be involved 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 require an estimated 159,225 burden hours (15 burden 

hours for each non TJC-accredited HHA x 10,615 non TJC-accredited HHAs = 159,225 burden 
 233

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 requirements would require 176,565 burden hours at a cost 

of $9,640,449. 

 We would also require HHAs to review and update their emergency preparedness plans 

at least annually. We believe that HHAs are already reviewing and updating their emergency 

preparedness plans periodically. Hence, compliance 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 based 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 least annually. We would require 

that, at a minimum, these policies and procedures address the requirements listed at 

§ 484.22(b)(1) through (6). 

 We expect that HHAs would review their emergency preparedness policies and 

procedures and compare them to their risk assessments, emergency preparedness plans, and 

emergency communication plans. HHAs would need to revise or, in some cases, develop new 

policies and procedures to ensure they complied with all of the proposed requirements. 

 In the chapter entitled, "Leadership," TJC accreditation standards require that each 

HHA’s "leaders develop policies and procedures that guide and support patient care, treatment, 

and services" (CAMHC, Standard LD.3.90, EP 1, p. LD-13). In addition, TJC accreditation 
 234

standards and EPs specifically require each HHA to develop and maintain an emergency 

management plan that provides processes for managing activities related to care, treatment, and 

services, including scheduling, modifying, or discontinuing services (CAMHC, Standard 

EC.4.10, EP 10, EC-9); identify backup 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 accreditation 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 individual 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 provisions at § 484.55. We expect that HHAs already 

collect data during the comprehensive 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 emergency preparedness officials about HHA patients in 

need of evacuation from their residences at any time due to an emergency situation based on the 

patients’ medical and psychiatric condition and home environment. 

 Existing HHA regulations already address some aspects of proposed § 484.22(b)(1) and 

(b)(2). For example, regulations at § 484.18 make it clear that HHAs are expected to accept 
 235

patients only on the basis of a reasonable expectation 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 necessary to protect the patient from injury § 484.18(a). 

Thus, the activities necessary to be in compliance with § 484.22(b)(1) and (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 emergency preparedness policies and procedures. 

However, we also expect that all HHAs would need to review their policies and procedures and 

revise and, if necessary, develop new policies and 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 representatives of most of the HHA’s major 

departments and assign staff to make necessary revisions and draft 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 222,282 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 . . . reviews the agency’s policies governing scope of services offered" 
 236

(42 CFR 484.16). Thus, we believe that complying 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 communication plan at least 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 health care facilities to maintain contact information for both 

staff and outside sources of assistance; alternate means of communication in case there is an 

interruption in phone service to the facility; and a method 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 case of failure due to an emergency (CAMHC, 

Standard EC.4.10, EP 18, p. EC-10). They are required 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 about 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 proposed 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 some contact information, an alternate means 

of communication, and a method for sharing information with other 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 this requirement would be the time and effort 

necessary for each HHA to review its existing communication 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 requirements. 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 requirements 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 and update their emergency preparedness 

communication plans at least annually. We believe that HHAs already review their emergency 

preparedness plans periodically. Thus, compliance 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 its 
 238

training and testing program at least annually. We propose requiring that each HHA meet the 

requirements listed at § 484.22(d)(1) and (2). 

 Proposed § 484.22(d)(1) states that each HHA would have to provide initial training in 

emergency preparedness policies and procedures 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 HHA would have to provide emergency 

preparedness training at least annually. Each HHA would also have to ensure that their staff 

could demonstrate knowledge of their emergency procedures. 

 Based on our experience with HHAs, we expect 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 initial 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 emergency preparedness is a critical aspect of jobrelated safety, we expect that TJC-accredited HHAs would ensure that their orientations and 

ongoing staff training would include the facility’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 risk 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, develop 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 their facilities’ emergency preparedness policies 
 239

and procedures to individuals providing services under arrangement and volunteers, consistent 

with their expected roles. Hence, we will analyze the burden of these proposed requirements for 

all 12,349 HHAs. 

 Based on our experience with HHAs, we expect that complying with this requirement 

would require the involvement of an administrator, the director of training, director of nursing, 

director of rehabilitation, and the office manager. We expect that the director 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 preparedness training and testing program at a cost of $756. Thus, for all 

12,349 HHAs to comply would require an estimated 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 annually. We believe that HHAs already review their training and 

testing programs periodically. Thus, compliance 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(d)(2) would require each HHA to conduct drills and exercises to test 

its emergency plan. Each HHA would have 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 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 plan, it would be exempt from engaging in a 
 240

community or individual, facility-based mock disaster 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, tabletop exercises, and emergency events, and revise its emergency 

plan as needed. For the purposes of determining 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 this requirement would be the time and effort 

necessary to develop the scenarios for the drill and the exercise and the required documentation. 

All TJC-accredited HHAs are required to test their emergency management plan once a year; the 

test cannot be a tabletop exercise (CAMHC, Standard EC.4.20, EP 1 and Note 1, p. EC-11). The 

TJC also requires HHAs to critique the drills and 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 accreditation standards would not ensure that TJCaccredited HHAs would be in compliance with our 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 expect that the same individuals who are 

responsible for developing the HHA’s training and 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 individuals. We estimate 

that it would require 8 burden hours for each HHA to comply with the proposed requirements at 
 241

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 estimate that it would require 909,855 burden hours 

for all HHAs to comply with the ICRs contained 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 Participation: Emergency Preparedness (§ 485.68)

 Proposed § 485.68(a) would require all Comprehensive 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 emergency 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, personnel, records, and the public during disasters" 

(§ 485.64). We expect that all CORFs have performed some type of risk assessment during the 

process of developing their disaster policies and procedures. However, their risk assessments 

may not meet our proposed requirements. Therefore, we expect that all CORFs would need to 

review their existing risk assessments and perform the tasks necessary to ensure that those 

assessments meet our proposed requirements. 

 We have not designated any specific process 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 conducting the risk assessment 

would require the involvement of the CORF’s administrator and a therapist. The type of 

therapists at each CORF varies, depending upon the services offered by the facility. For the 

purposes of determining the burden, we will assume that the therapist is a physical therapist. We 
 243

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

relevant sections of the 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 administrator would coordinate the meetings, review and 

critique the risk assessment, coordinate comments, develop the new risk assessment, and ensure 

that it was approved. 

 We estimate that complying with this requirement would require 8 burden hours at a cost 

of $485. There are currently 272 CORFs. Therefore, 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 CORF would need to review, revise, and, if 

necessary, develop new sections for its emergency plan so that it complied with our proposed 

requirements. The current CoPs for CORFs require 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 concerning the transfer of casualties and records, 

notification of outside emergency personnel, and evacuation routes (§ 485.64(a)). Thus, we 

expect that all CORFs have some type of emergency preparedness plan. 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 administrator and physical 

therapist who were involved in developing the risk assessment would be involved in developing 

the emergency preparedness plan. However, we expect that it would require more time to 
 244

complete the emergency plan than to complete the risk assessment. We estimate that complying 

with this requirement would require 11 burden 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 for each CORF x 272 CORFs = $184,144 estimated 

cost). 

 The CORF also would be required to review and update its emergency preparedness plan 

at least annually. We believe that CORFs already review their plans periodically. 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), respectively. We would also 

require CORFs to review and update these policies and procedures at least annually. We would 

require that a CORF’s policies and procedures address, at a minimum, the requirements listed at 

§ 485.68(b)(1) through (4). 

 We expect that all CORFs have some emergency preparedness policies and procedures. 

As discussed earlier, the current CoPs for CORFs already require CORFs to have "written 

policies and procedures that specifically define the handling of patients, personnel, records, and 

the public during disasters" (42 CFR 485.64). However, all CORFs would need to review their 

policies and procedures and compare them to their risk assessments, emergency preparedness 

plans, and communication plans. Most CORFs would need to revise their existing policies and 
 245

procedures or develop new policies and procedures to ensure they complied with all of our 

proposed requirements. 

 We expect that both the administrator and the 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, coordinate 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 with this requirement at a 

cost of $149,328 ($549 estimated cost for each CORF x 272 CORFs = $149,328 estimated cost). 

 Proposed § 485.68(b) also proposes that CORFs review and update their emergency 

preparedness policies and procedures at least annually. We believe that CORFs already review 

their policies and procedures periodically. Therefore, we believe that complying with this 

requirement 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(c) would require CORFs to develop and maintain emergency 

preparedness communication plans that complied with both federal and state law and that would 

be reviewed and updated at least 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 include, 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 their patients. However, many CORFs may not have 

formal, written emergency preparedness communication 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 require the involvement of the CORF’s administrator with the 

assistance of a physical therapist to review, revise, and, if needed, develop new sections for the 

CORF’s emergency preparedness communication plan. We estimate that it would take 8 burden 

hours for each CORF to comply with 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 annually. We believe that compliance with this 

requirement 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(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 satisfy the requirements listed at § 485.68(d)(1) and 

(2). 
 247

 Proposed § 485.68(d)(1) would require that each CORF provide initial training in 

emergency preparedness policies and procedures 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, each CORF would have to provide 

emergency preparedness training at least annually. Each CORF would also have to ensure that 

its staff could demonstrate knowledge of its emergency procedures. All new personnel would 

have to be oriented and assigned specific responsibilities regarding the CORF’s emergency plan 

within two weeks of their first workday. In addition, the training program would have to include 

instruction in the location and use of alarm systems and signals and firefighting equipment. 

 The current CORF CoPs at § 485.64 require CORFs to ensure that all personnel are 

knowledgeable, trained, and assigned specific responsibilities regarding the facility’s disaster 

procedures. Section § 485.64(b)(1) specifies that CORFs must also "provide ongoing training . . 

. for all personnel associated with the facility in all aspects of disaster preparedness". In 

addition, § 485.64(b)(2) specifies that "all new personnel must be oriented and assigned specific 

responsibilities regarding 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 program for new employees, as well as ongoing 

training for all staff. However, under this proposed rule, all CORFs would need to compare their 

current training programs to their risk assessments, emergency preparedness plans, policies and 

procedures, and communication plans. CORFs would then need to revise, and in some cases, 

develop new material for their training programs. 

 We expect that these tasks would require the involvement of an administrator and a 

physical therapist. We expect that the administrator would review the CORF’s current training 
 248

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 updated training program. 

We estimate it would require 8 burden hours for each CORF to develop an emergency training 

program at a cost of $485. Therefore, for all CORFs 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 emergency preparedness training 

program at least annually. We believe that CORFs already review their training programs 

periodically. Thus, complying with the requirement 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 PRA 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 exercise at least annually. If a community mock 

disaster drill was not available, the CORF would have to conduct an individual, facility-based 

mock disaster drill at least annually. If a CORF experienced an actual natural 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 following the onset of the 

actual event. CORFs would also be required to analyze their responses to and maintain 

documentation of all drills, tabletop exercises, and emergency events, and revise their emergency 

plans, as needed. To comply with this requirement, 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 with the facility in all aspects of disaster 
 249

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 scenarios for their drills and tabletop exercises. 

 Based on our experience with CORFs, we expect that the same individuals who develop 

the emergency preparedness training program would develop the scenarios for the drills and 

exercises, as well as the accompanying documentation. We expect that the administrator would 

spend more time on these tasks than the physical therapist. We estimate that for each CORF to 

comply with the proposed requirements would require 6 burden hours at a cost of $366. 

Therefore, for all 272 CORFs to comply would 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 CORFs to comply with the ICRs contained in 

this proposed rule would require 13,600 total burden hours at a total cost of $828,784. 
 250

TABLE 11: BURDEN HOURS AND COST 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 Participation: Emergency Preparedness (§ 485.625)

 Proposed § 485.625(a) would require critical access hospitals (CAHs) to develop and 

maintain a comprehensive emergency preparedness program 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 utilizing an all-hazards approach. CAHs would 

need to review their existing risk assessments and 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 CAHs. Many of the TJC and AOA accreditation 
 251

standards for CAHs are similar to the requirements in this proposed rule. For purposes of 

determining the burden, we have analyzed the burden for the 370 TJC-accredited and 32 AOAaccredited CAHs separately from the non-accredited CAHs. Note that we obtain data on the 

number of CAHs, both accredited and non-accredited, 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 Critical Access Hospitals: The Official Handbook 

2008 (CAMCAH). In the chapter entitled, "Management 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 Refreshed Care, January 2008, pp. EC-10 - EC-11). 

CAHs are required to perform a hazard vulnerability 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 likelihood 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 impact on the care, treatment, and services [the 

CAH] must sustain during an emergency," 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, Introduction, 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 assessment 
 252

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). 

 For purposes of determining the burden for AOA-accredited CAHs, we used the AOA’s 

Healthcare Facilities Accreditation Program: Accreditation Requirements for Critical Access 

CAHs 2007 (ARCAH). In Chapter 11 entitled, "Physical Environment," CAHs are required to 

have disaster plans, external disaster plans that include 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 appropriate responses" (ARCAH, Standard 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 not require a documented facility-based and 

community-based risk assessment, as we propose. 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 assure the safety of their patients in nonmedical emergencies (§ 485.623) and to take appropriate measures that are consistent with the 

particular conditions in the area in which the CAH is located (42 CFR 485.623(c)(4)). To satisfy 

this requirement in the CoPs, we expect that CAHs have already conducted some type of risk 

assessment. However, that requirement does not ensure that CAHs 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 process or format for CAHs to use in conducting 

their risk assessments because we believe that CAHs 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 departments in the process of developing their risk 

assessments. 

 Based on our experience with CAHs, we expect that these activities would require the 

involvement of a CAH’s administrator, medical director, director of nursing, facilities director, 

and food services director. We expect that these individuals would attend an initial meeting, 

review relevant sections of the current risk assessment, provide comments, attend a follow-up 

meeting, perform a final review, and approve the new or updated risk assessment. We expect the 

administrator would coordinate the meetings, perform 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 requirement 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 assessment requirement would require 14,280 burden hours (15 burden 

hours for each CAH x 952 non TJC-accredited CAHs = 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 emergency 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 and maintain an Emergency Operations Plan 

(EOP) (CAMCAH Standard EC.4.12, p. EC-10a). The EOP must cover the management of six 

critical areas during emergencies: 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 conduct 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 requirement, 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 the 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 risks 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 transfer of patients to home or other health care 

settings (ARCAH, Standard 11.02.02, p. 11-5). In addition, there are requirements for disaster 
 255

and disaster response plans (ARCAH, Standards 11.07.01, 11.07.02, and 11.07.06, pp. 11-38 

through 11-40). There also are specific requirements for plans for responses 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 utilizing an all-hazards approach. Thus, we expect that AOAaccredited CAHs would have to compare their risk assessments they conducted in accordance 

with proposed § 485.625(a)(1) to their current plans and then revise, 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 the 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, emergency 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 their 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-accredited CAHs would have to 

review their current plans and compare them to their risk assessments and revise and, in some 

cases, develop new sections for their current plans to ensure that their plans would satisfy our 

proposed requirements. 

 Based on our experience with CAHs, we expect that the same individuals who were 

involved in conducting the risk assessment would be involved in developing the emergency 
 256

preparedness plan. We expect that these individuals would attend 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, and ensure that the necessary parties approve the 

new plan. We estimate that complying with this requirement would require 26 burden hours at a 

cost of $1,620. Therefore, we estimate that 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 24,752 burden hours (26 burden hours for each non 

TJC-accredited CAH x 952 non TJC-accredited CAHs = 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 would 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 program at least once a year (§ 485.641(a)(1)). 

Hence, all CAHs should already have an individual or team responsible that 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 require CAHs to develop and maintain 

emergency preparedness policies and procedures based on their emergency plans, risk 

assessments, and communication plans as set forth in § 485.625(a), (a)(1), and (c), respectively. 

We would also require CAHs to review and update these policies and procedures at least 
 257

annually. These policies and procedures would have to address, at a minimum, the requirements 

listed at § 485.625(b)(1) through (8). 

 We expect that all CAHs would review their policies and procedures and compare them 

to their risk assessments, emergency preparedness 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, "Leadership" (LD), requires TJC-accredited CAH 

leaders to "develop policies and procedures that guide and support 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 CAHs already have some policies and procedures 

for the activities and processes required for accreditation, including their EOP. As discussed 

later, many of the required elements we propose 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 obtaining and replenishing medical and non-medical 

supplies, including food, water, and fuel for generators and transportation vehicles (CAMCAH, 

Standard EC.4.14, EPs 1-4, p. EC-10d). In addition, they must identify alternative means of 

providing electricity, water, fuel, and other essential utility needs in cases where their usual 

supply is disrupted or compromised (CAMCAH, Standard EC.4.17, EPs 1-5, p. EC-10f). We 

expect that TJC-accredited CAHs that comply with these requirements would be in compliance 

with our proposed requirement concerning 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 patients 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 that 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 patients, their information, medications, supplies, 

and equipment to alternative care sites (ACSs) when the CAH cannot provide care, treatment, 

and services in its facility (CAMCAH, Standard EC.4.14, EPs 9-11, p. EC-10d). We expect that 

TJC-accredited CAHs that comply with these requirements 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 may result in the decision to 

keep all patients on the premises in the interest 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 documentation that preserves patient information, protects the 

confidentiality of patient information, and ensures that records are secure and readily available. 
 259

The CAMCAH chapter entitled "Management of Information" (IM), requires TJC-accredited 

CAHs to have storage and retrieval 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 continuity of their critical information for patient care, treatment, 

and services (CAMCAH, Standard IM.2.30, CAMCAH Refreshed Core, January 2008, p. IM-9). 

They also must ensure the privacy and confidentiality of patient information (CAMCAH, 

Standard IM.2.10, CAMCAH Refreshed Core, January 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, respectively). 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 emergency staffing strategies. TJCaccredited CAHs must define staff roles and responsibilities in their EOP and ensure that they 

train their staff for their assigned roles (CAMCAH, Standard EC.4.16, EPs 1 and 2, p. EC-10e). 

Also, the rationale for Standard EC.4.15 indicates 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 disaster 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 the chapter entitled "Management of Human 

Resources" (HR), CAHs "may assign disaster responsibilities to volunteer practitioners" 

(CAMCAH, Standard HR.1.25, CAMCAH Refreshed Core, January 2008, p. HR-6). Although 
 260

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

believe TJC-accredited CAHs would be in compliance with all requirements in proposed 

§ 485.625(b)(6). 

 Based upon the previous discussion, we expect that the activities required for compliance 

by TJC-accredited CAHs with § 485.625(b)(1) through (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 contain requirements for policies and procedures 

related to safety and disaster preparedness. The AOA-accredited CAHs are required to maintain 

plans and performance standards for disaster preparedness (ARCAH, 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 department and service within the CAH and for 

each building used for patient treatment or housing" (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 related 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-accredited CAHs are required to consider 

"pharmaceuticals, food, other supplies and equipment that may be needed during 

emergency/disaster situations" and "provisions if gas, water, electricity supply is shut off to the 

community" when they are developing their 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-accredited 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, Element 7, p. 11-6). They also are required 

to have a "call tree" in their external disaster plan that must 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 location of staff and patients during and after an 

emergency. 

 In regard to proposed § 485.625(b)(3), which requires policies and procedures regarding 

the safe evacuation from the facility, AOA-accredited CAHs are required to consider the 

"transfer or discharge of patients to home, other healthcare settings, or other CAHs" and the 

"transfer of patients with CAH equipment to another CAH or healthcare 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 plans how to maintain communication with external 

entities should their telephones and computers either cease to operate or become overloaded 
 262

(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" (ARCAH, Standard 11.02.02 Building Safety, pp. 11-4 

through 11-7). However, we do not believe these 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-accredited 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 earlier, they also must 

consider the food, pharmaceuticals, and other supplies 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 specifically mention volunteers and CAHs are required 

only to consider these elements in developing their plans. 

 Therefore, we believe that AOA-accredited CAHs have likely 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 policies and procedures and perform whatever 

tasks are necessary to ensure that they complied with all of our proposed requirements for 

emergency policies and procedures. Because we expect that AOA-accredited CAHs already 

comply with many of our proposed requirements, 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 comply with all of our proposed requirements for 
 263

emergency policies and procedures. Based on our experience working with CAHs, we expect 

that accomplishing these activities would require the involvement of an administrator, the 

medical director, director of nursing, facilities director, and food services director. We expect 

that the administrator would review the policies and procedures and make recommendations for 

necessary changes or additional policies or procedures. The CAH administrator would brief 

other staff and assign staff to make 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 hours 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 activities associated 

with our proposed requirements are 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 development of emergency policies and procedures 

would be the resources needed to review, revise, and if needed, develop emergency preparedness 

policies and procedures that include our proposed requirements. We believe the individuals and 
 264

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 compliance 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 estimated 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 also require CAHs to review and update their emergency 

preparedness policies and procedures at least annually. As discussed earlier, TJC and AOAaccredited CAHs already periodically review their policies and procedures. In addition, the 

existing CAH CoPs require periodic reviews of the CAH’s health care policies (§ 485.627(a), 

§ 485.635(a), and § 485.641(a)(1)(iii)). Thus, compliance with this requirement would constitute 

a usual and customary business practice for all CAHs and would not be subject 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 annually. We propose that these 

communication plans include the information listed at § 485.625(c)(1) through (7). 

 We expect that all CAHs would review their emergency preparedness communication 

plans and compare them to their risk assessments and emergency plans. We also expect that 

CAHs would revise and, if necessary, develop new sections that would comply with our 
 265

proposed requirements. Based on our experience with CAHs, they generally have some type of 

emergency preparedness communication plan. Further, it is 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 for their patients. 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 and, 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 for emergency communications (CAMCAH, Standard 

4.13, p. EC-10b -10c). These plans must cover both internal and external communications and 

include back-up technologies 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 ensure 

compliance 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 emergencies (AOA Standard 11.02.02). These plans must 

specifically include both internal and external communications (AOA Standard 11.02.02, 

Elements 6, 7, and 10). Based on these standards, we do not believe they ensure compliance 

with proposed § 485.625(c)(4) through (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 complied 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 communication plan and make recommendations for 

necessary changes or additions. The director of nursing and the facilities director would meet 

with the administrator to discuss and revise or draft new sections for the CAH’s existing 

emergency communication plan. We estimate that 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 emergency preparedness communication plan would require 

11,898 burden hours (9 burden hours for each CAH x 1,322 CAHs = 11,898 burden hours) at a 

cost of $686,118 ($519 estimated cost for each CAH 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 annually. All CAHs are required to evaluate their 

entire program at least annually (§ 485.641(a)). Therefore, compliance 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 annually. 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, including prompt reporting and extinguishing fires, 

protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, 

and cooperation with firefighting and disaster authorities, to all new and existing staff, 
 267

individuals providing services under arrangement, and volunteers, consistent with their expected 

roles, and maintain documentation of the training. Thereafter, the CAH would have to provide 

emergency preparedness training at least annually. 

 We expect that all CAHs would review their current training programs and compare them 

to their risk assessments and emergency preparedness 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 their training and testing programs complied with 

our proposed requirements. 

 Current CoPs require CAHs to train their staffs on how to handle emergencies 

(§ 485.623(c)(1)). However, this training primarily addresses internal emergencies, such as a 

fire inside the facility. In addition, both TJC and AOA require CAHs 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, Standards HR.2.10 and 2.30, pp. HR-8 and HR—9, 

respectively). On-going training 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 emergency 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 destruction (AOA Standard 11.07.07). 

 Thus, we expect that all CAHs provide some 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, policies and procedures, and communication plans 

and then revise or, in some cases, develop new sections for their training programs to ensure 
 268

compliance with our proposed requirements. They also would need to revise, update, or, in some 

cases, develop new materials for the 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 the initial review of the 

training program, brief the administrator and the director of facilities, 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 emergency preparedness training 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 least annually. Existing regulations require all 

CAHs to evaluate their entire program at least annually (§ 485.641(a)). Therefore, compliance 

with this proposed 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). 

 The CAHs also would be required to maintain 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 usual 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 exercise 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 drills, 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 emergency (proposed § 485.625(d)(2)(ii)). Thus, to 

meet these requirements, CAHs would need to develop scenarios for each drill and exercise and 

develop the required documentation. 

 If a CAH participated in a community mock disaster drill, it would 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 scenarios 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 (CAMCAH, Standard EC.4.20, EP 1, p. EC-12). These 

tests must be monitored, documented, and analyzed (CAMCAH, Standard EC.4.20, EPs 8-19, 

pp. EC-12 – EC-13). Thus, we believe that TJC-accredited CAHs already develop scenarios for 

these tests. We also expect that they also have developed the documentation necessary to record 

and analyze their tests and responses to actual emergency events. Therefore, compliance with 

this requirement would constitute a usual and customary business practice for TJC-accredited 

CAHs and would not be subject to the PRA 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 11.07.09). We expect that since 

AOA-accredited CAHs already conduct disaster drills, they also develop scenarios for the drills. 

In addition, it is standard practice in the health care industry to document and analyze tests that a 

facility conducts. Thus, compliance 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 preparedness training program and conduct some type of 

drills or exercises to test their emergency preparedness plans. However, 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 required to develop scenarios for a mock 

disaster drill and a paper-based, tabletop exercise and the documentation 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 the 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 and 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. Therefore, for all 920 non-accredited CAHs to comply 

with these requirements would require an estimated 7,360 burden hours (8 burden hours for each 
 271

non-accredited CAH x 920 non-accredited CAHs = 7,360 burden hours) at a cost of $448,960 

($488 estimated cost for each non-accredited 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 CONTAINED 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 and 

AOAAccredited) 

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 the wages for multiple staffing levels. 

O. ICRs Regarding Condition of Participation: Emergency Preparedness (§ 485.727)

 Proposed § 485.727(a) would require clinics, rehabilitation agencies, and public health 

agencies as providers of outpatient physical therapy and speech-language pathology services 

(organizations) to develop and maintain emergency preparedness 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 organizations to develop documented, facilitybased and community-based risk assessment utilizing an all-hazards approach. Organizations 
 272

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

both at their facilities and in the surrounding area. 

 The current CoPs for Organizations require these providers to have "a written plan in 

operation, with procedures to be followed in the event of fire, explosion, or other disaster" 

(§ 485.727(a)). To comply with this CoP, we expect that all of these providers have already 

performed some type of risk assessment during the process of developing their disaster plans and 

policies and procedures. However, these providers would need to review their current risk 

assessments and make any revisions to ensure they 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 believe 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 departments in the process of developing their risk 

assessments. Based on our experience with these 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 administrator and the therapist would attend an initial 

meeting, review the current assessment, develop comments and recommendations for changes to 

the assessment, attend a follow-up meeting, perform a final review, and approve the new risk 

assessment. We expect that the administrator 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 risk 
 273

assessment than the physical therapist. We estimate that complying 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 requirement 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 review 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 and records, the location and use of alarm systems and signals, methods of 

containing fire, notification of appropriate persons, and evacuation routes and procedures 

(§ 485.727(a)). Thus, we expect that 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 current 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 emergency preparedness plan that complied with our 

proposed requirements. 

 Based on our experience with these organizations, we expect that the administrator and 

physical therapist who were involved in developing the risk assessment would be involved in 

developing the emergency preparedness plan. However, we expect it would require more time to 

complete the plan and that the administrator would be the most heavily involved in reviewing 

and developing the organization’s emergency preparedness plan. We estimate that for each 

organization to comply would require 12 burden hours at a cost of $741. We estimate that it 
 274

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 required to review and update its emergency 

preparedness plan at least annually. We believe that these organizations already review their 

plans periodically. Thus, complying with this requirement would constitute 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 require 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 procedures at least annually. At a 

minimum, we would require that an organization’s policies and procedures address the 

requirements listed at § 485.727(b)(1) through (4). 

 We expect that all organizations have emergency 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 procedures 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) through (5). However, all organizations would 

need to review their policies and procedures, assess whether their policies and procedures 

incorporate all of the necessary elements of their emergency preparedness program, and, if 
 275

necessary, take the appropriate steps to ensure that their policies and 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 estimate that for all organizations to comply would 

require 22,560 burden hours (10 burden hours for each organization x 2,256 organizations = 

23,550 burden hours) at a cost of $1,382,928 ($622 estimated cost for each organization x 2,256 

organizations = $1,382,928 estimated cost). 

 We would require organizations to review and update their emergency preparedness 

policies and procedures at least annually. We believe that these providers already review their 

emergency preparedness policies and procedures periodically. Therefore, 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 § 485.727(c) would require organizations to develop and maintain emergency 

preparedness communication plans that complied with both federal and state law and would be 

reviewed and updated at least annually. The communication 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 organizations already require them to have a 

written disaster plan with procedures 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 is 
 276

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 for 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 organizations, we anticipate that satisfying the 

requirements in this section would primarily require the involvement of the organization’s 

administrator with the assistance 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 customary business practice and would not be subject 

to the PRA in accordance with 5 CFR 1320.3(b)(2). 

 Proposed § 485.727(d) would require organizations to develop and maintain emergency 

preparedness training and testing programs and review and update these programs at least 
 277

annually. Specifically, we are proposing 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 existing staff, individuals 

providing services under arrangement, and volunteers, consistent with their expected roles, and 

maintain documentation of the training. Thereafter, the CAH would have to provide emergency 

preparedness training at least annually. 

 Current CoPs require organizations to ensure that "all employees are 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 employees, 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 preparedness 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 requirement would require the involvement of an 

administrator and a physical therapist. We expect that the administrator would primarily be 

involved in reviewing the organization’s current training program and the current emergency 

preparedness program; determining what tasks would need to be performed and what materials 

would need to be developed to comply with our proposed requirements; 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 training program. We estimate that it would 
 278

require 8 burden hours for each organization to develop a comprehensive emergency training 

program at a cost of $494. Therefore, it would require an estimated 18,048 burden hours 

(8 burden hours for each organization x 2,256 organizations = 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 program at least annually. We believe that these 

providers already review their emergency preparedness training 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). 

 Proposed § 485.727(d)(2) would require organizations to participate in a community 

mock disaster drill and a paper-based, tabletop exercise at least annually. If a community mock 

disaster drill was not available, the organization would have to conduct an individual, facilitybased mock disaster drill at least annually. If an organization experienced an actual natural 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 following the 

onset of the actual event. Organizations 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 with this requirement, an organization would need 

to develop scenarios for their drills and exercises. An organization also would have to develop 

the documentation necessary for recording and analyzing their responses to drills, exercises, and 

actual emergency events. 
 279

 The current CoPs require organizations to have a written disaster plan that is 

"periodically rehearsed" and have "ongoing . . . drills" (§ 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 specify the type of drill, how they are to conduct 

the drills, or whether the drills should be community-based. In addition, there is no requirement 

for a paper-based, tabletop exercise. Thus, these requirements do not ensure that organizations 

would be in compliance with our proposed requirements. Therefore, we will analyze the burden 

from these requirements for all organizations. 

 The 2,256 organizations would be required to develop scenarios for a mock disaster drill 

and a paper-based, tabletop exercise and the necessary documentation. Based on our experience 

with organizations, we expect that the same 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 the scenarios and the documentation. We estimate that for each 

organization to comply would require 3 burden hours at a cost of $183. Based on that estimate, 

it would require 6,768 burden hours (3 burden hours for each organization x 2,256 organizations 

= 6,768 burden hours) at a cost of $417,360 ($183 estimated cost for each organization x 2,256 

organizations = $417,360 estimate cost). 

TABLE 13: BURDEN HOURS AND 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 1,671,696 
 280

(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 Participation: 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 the plan must meet the requirements listed at 

§ 485.920(a)(1) through (4). 

 We expect all CMHCs to identify the likely medical and non-medical emergency events 

they could experience within the facility and the community in which it is located and determine 

the likelihood of the facility experiencing 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 needed for a risk assessment because it is standard 

practice for health care organizations to prepare 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 current 
 281

risk assessment and perform the tasks necessary to ensure that the facility’s risk assessment 

complies with the proposed requirements. 

 We do not propose designating 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 input from all major departments. Based on our experience with 

CMHCs, we expect that conducting the risk assessment would require 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 individuals 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, perform a final review, and approve the risk 

assessment. We expect that the administrator 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 assessment, and assure that the necessary parties 

approve the new risk assessment. It is likely that the CMHC administrator would spend more 

time reviewing and working on the risk assessment than 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 plan, 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 organizations to make plans for common disasters 

they may confront, such as fires, interruptions in communication and power, and storms. Thus, 

we expect that all CMHCs have some type of emergency preparedness plan. However, their plan 

may not address all likely medical and non-medical emergency events identified by the risk 

assessment. Further, their plans may not include strategies for addressing likely emergency 

events or address their patient population, the type of services they have the ability to provide in 

an emergency, or continuity of operation, including delegations of authority and succession 

plans. We expect that CMHCs would have to review their current plan and compare it to their 

risk assessment, as well as to the other requirements in proposed § 485.920(a). We expect that 

most CMHCs would need to update and revise their existing emergency plan and, in some cases, 

develop new sections to comply with 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, and develop new sections for an 

existing emergency plan. Based upon our experience 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 expect that the administrator and a psychiatric nurse 

would spend more time reviewing and developing the CMHC’s emergency preparedness plan. 
 283

We expect that the clinical social worker or mental health counselor would 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 emergency plan at a cost of $750. Based on this estimate, it would 

require 3,105 burden hours (15 burden hours 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 and update its emergency preparedness plan at 

least annually. For the purpose of determining 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 administrator that is responsible for the day-to-day 

operation of the CMHC. This would include ensuring that all of the CMHC’s plans are up-todate and comply with the relevant federal, state, and local laws, regulations, and ordinances. In 

addition, it is standard practice in the health care industry for facilities to have a professional 

staff person, generally an administrator, who periodically reviews their plans and procedures. 

We expect that complying with the requirement for an annual review of the emergency 

preparedness plan would constitute a usual and customary business practice for CMHCs. As 

stated in 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a 

collection of information that would be incurred 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 update these policies and 
 284

procedures at least annually. The CMHC’s policies and procedures would be required to 

address, at a minimum, the requirements listed at § 485.920(b)(1) through (7). 

 We expect that all CMHCs would compare their current emergency preparedness policies 

and procedures to their emergency preparedness plan, communication plan, and their training 

and testing program. They would need to review, revise and, if necessary, 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 needed, developing any new policies and procedures. We estimate 

that for a CMHC to comply with this proposed requirement would require 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 estimated 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 day-to-day operation of 

the CMHC, which includes ensuring that all of the 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 responsible for periodically reviewing the emergency 

preparedness policies and procedures as part of his or her responsibilities. We expect that 
 285

complying with the requirement for an annual review 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 financial resources necessary to comply with a 

collection of information that would be incurred 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 compare 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 type of emergency preparedness communications 

plan. However, their emergency communications plan may not be thoroughly documented or 

comply with all of the elements we are requiring. It is standard practice 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 sharing information and medical documentation 

with other health care providers to ensure continuity of care for their patients. However, we 

expect that all CMHCs would need to review, update, and in some 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 expect the involvement of the 

CMHC’s administrator and the psychiatric registered 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 proposed 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 review and update their emergency preparedness 

communication plan at least annually. For the 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 administrator who is responsible for the day-today operation of the CMHC. This includes ensuring that all of the CMHC’s policies and 

procedures are up-to-date and comply with the relevant federal, state, and local laws, regulations, 

and ordinances. We expect that the administrator is responsible 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 require only a negligible burden. 

Complying with the proposed requirement for an annual review of the emergency preparedness 

communications plan constitutes a usual and customary business practice for CMHCs. As stated 

in 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a 

collection of information that would be incurred 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 reviewed and updated at least 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 assessment and updated emergency 

preparedness plan, policies and procedures, and communications plan and review, revise, and, if 

necessary, develop new sections for their training 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 complying with this requirement would include the 

involvement of a psychiatric registered 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 materials 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 training program at a cost of $414. Therefore, it 

would require an estimated 2,070 burden hours (10 burden hours for each CMHC x 207 CMHCs 

= 2,070 burden hours) to comply with this proposed 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 least annually. For the purpose of determining the 

burden for this proposed requirement, we will expect that CMHCs would review their emergency 

preparedness training program annually. We expect that all CMHCs have a professional staff 
 288

person, probably a psychiatric registered nurse, who is responsible for periodically reviewing 

their training program to ensure that it is up-to-date and complies with the relevant federal, state, 

and local laws, regulations, and ordinances. In addition, we expect that an annual review of the 

CMHC’s emergency preparedness training program would require only a negligible burden. 

Thus, we expect that complying with the proposed requirement for an annual review of the 

emergency preparedness training program constitutes a usual and customary business practice 

for CMHCs. As stated in 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary 

to comply with a collection of information that 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 annually. 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 each 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 expect 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 emergency preparedness plans. However, we do not 

know what type of drills or exercises they typically conduct or how often they are performed. 

We also do not know how, or if, they are documenting and analyzing their responses to these 

drills and tests. For the purpose of determining a burden for these proposed requirements, we 

will expect that all CMHCs need to develop two scenarios, one for the drill and one for the 

exercise, and develop the documentation necessary to record the facility’s responses. 
 289

 The associated burden would be the time and effort necessary to comply with the 

requirement. We expect that complying with this proposed requirement would likely require the 

involvement of a psychiatric registered nurse. We expect that the psychiatric registered nurse 

would develop the documentation necessary for both 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 estimated cost for each CMHC x 207 CMHCs = 

$34,362 estimated cost). 

TABLE 14: BURDEN HOURS AND COST ESTIMATES FOR ALL 207 CMHCs 

TO COMPLY WITH THE ICRs CONTAINED 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 Participation: Emergency Preparedness (§ 486.360)
 290

 Proposed § 486.360(a) would require Organ Procurement Organizations (OPOs) to 

develop and maintain emergency preparedness plans that would have to be reviewed and updated 

at least annually. These plans would have to comply with 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 have 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 surrounding area, including branch offices 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 documented 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 their current risk assessments and perform the necessary tasks to 

ensure that their risk assessment complied with the requirements of this proposed rule. Based on 

our experience with OPOs, we believe that conducting a risk assessment would require the 

involvement of the OPO’s director, medical director, quality assessment and performance 

improvement (QAPI) director, and an organ procurement coordinator (OPC). We expect that 
 291

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 risk 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 that 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 OPO during the Katrina disaster), OPOs already 

have plans to ensure that services will continue to be provided in their donation service areas 

(DSAs) during an emergency. However, we do not expect that all OPOs would have emergency 

preparedness plans that would satisfy the requirements of this section. 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 would need to revise, and in some cases develop, 

new sections to ensure their plan satisfied the proposed requirements. 
 292

 We expect that the same individuals who were involved in the risk assessment would be 

involved in developing the emergency preparedness plan. We expect that these individuals 

would attend an initial meeting, review relevant sections of the OPO’s current emergency 

preparedness plan, prepare and 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 plan, coordinate comments, ensure that the 

appropriate individuals revise the plan, and ensure that the necessary 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 the 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 and update their emergency preparedness plans at 

least annually. We believe that all of the OPOs already review their emergency preparedness 

plans periodically. Thus, compliance with this 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 forth in proposed § 486.360(a)(1), (a), and (c), 

respectively. It would also require OPOs to review and update these policies and procedures at 
 293

least annually. The OPO’s policies and procedures 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 considered necessary for the effective administration 

of the OPO, including . . . the 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 procedures 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 resources needed to develop emergency 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 would need to review their 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 their reviews, OPOs would need to develop and 

implement the policies and procedures necessary to ensure that they initiate and maintain their 

emergency preparedness plans, agreements, and protocols. 

 Based on our experience with OPOs, we expect 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 that all of these individuals would review the 
 294

OPO’s current policies and procedures; compare 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; and participate in developing the 

final version of the policies and procedures. 

 We expect that the QAPI director would likely coordinate the meetings; coordinate and 

incorporate comments; draft the revised or new policies and procedures; 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 emergency preparedness policies and procedures at a 

cost of $1,482. Therefore, for all 58 OPOs to comply 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 and update their emergency preparedness policies 

and procedures at least annually. We believe that OPOs already review their emergency 

preparedness policies and procedures periodically. Therefore, 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 § 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 hospitals 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 Network (OPTN), other healthcare providers, other 

OPOs, and potential and actual donors’ next-of-kin. 

 Thus, we expect that the nature of their work would ensure that all OPOs have already 

addressed at least some of the elements 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 means of communication for their 

staffs. However, we do not believe that all OPOs have developed formal plans that include all of 

the proposed elements contained in this requirement. The burden would be the resources needed 

to develop an emergency preparedness communications plan that would 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, and OPC. We expect that all 

of these individuals would need to review the OPO’s current plans, policies, 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 procedures. We expect that these individuals 

would review the materials described earlier, submit comments to the QAPI director, review 

revisions and additions, and give 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 comments into a new communications plan, as 

appropriate; and ensure that the necessary individuals 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. Therefore, 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 annually. We believe that all of the OPOs already review their 

emergency preparedness communication plans periodically. Thus, compliance with this 

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(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 existing staff, individuals 

providing services under arrangement, and volunteers, consistent with their expected roles, and 

maintain documentation of that training. OPOs must also ensure that their staff can demonstrate 

knowledge of their emergency procedures. Thereafter, 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 services the OPO is required to provide, including 

applicable organizational policies and procedures and QAPI activities (§ 486.326(c)). However, 

since there are no specific emergency preparedness requirements in the current OPO CfCs, we 
 297

do not believe that the content of their existing training would comply with the proposed 

requirements. 

 We expect that OPOs would develop a comprehensive emergency preparedness training 

program for their staffs. Based upon our experience with OPOs, we expect that complying with 

this proposed requirement would require the OPO director, medical director, the QAPI director, 

an OPC, and the education coordinator. We expect that the QAPI director and the education 

coordinator would review the OPO’s risk assessment, emergency preparedness plan, policies and 

procedures, and communication plan and make recommendations regarding 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 education coordinator and assist in the review, provide comments, 

and approve the new emergency preparedness training program. 

 We estimate that it would require 40 burden hours for each OPO to develop an 

emergency preparedness training program that complied with these requirements at a cost of 

$2,406. Therefore, we estimate that for all 58 OPOs to comply with this requirement would 

require 2,320 burden hours (40 burden hours for 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 update their emergency preparedness training 

programs at least annually. We believe that all of the OPOs already review their emergency 

preparedness training programs periodically. Therefore, compliance with this 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). 
 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 contain a requirement for OPOs to conduct a 

paper-based, tabletop exercise. However, OPOs are required to evaluate their staffs’ 

performance and provide training to improve individual and overall 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 would include developing a 

scenario for and documenting the exercise. Thus, compliance with these requirements 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). 

 We expect that the QAPI director and the education coordinator would work together to 

develop the scenario for the exercise and the necessary documentation. We expect that the QAPI 

director would likely spend more time on these activities. 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 burden 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 essential organ procurement services to all or a portion of the 

OPO’s DSA in the event that the OPO cannot provide such services due to an emergency. This 
 299

section would also require each OPO to include in the hospital agreements 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 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 resources 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 director, QAPI director, OPC, and an attorney 

would be involved in completing the tasks necessary to develop these agreements. We expect 

that all of these individuals would 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 agreement 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 essential organ procurement services to all or a portion of its DSA 

during an emergency at a cost of $1,658. Therefore, 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 required 
 300

under § 486.344(d), the duties and responsibilities of the hospital, transplant 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 draft 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 required 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 language for both types of documents. In addition, we expect that 

the OPO director, medical director, QAPI director, and OPC would work with the attorney in 

developing this standard language. 

 We estimate that it would require 13 burden 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 OPOs 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 CONTAINED IN § 486.360 CONDITION: EMERGENCY 

PREPAREDNESS 
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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 Participation: Emergency Preparedness (§ 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 plans 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 RHCs/FQHCs to develop a documented, 

facility-based and community-based risk assessment 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 the surrounding area. RHCs/FQHCs would need to 

review any existing risk assessments and then update and revise those assessments or develop 

new sections for them so that those assessments complied with our proposed requirements. 

 We obtained the total number of RHCs and FQHCs used in this burden analysis from the 

CMS CASPER data system, which the states update periodically. Due to variations in the 

timeliness of the data submission, all numbers in this analysis are approximate. 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 Administration 
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(HRSA) issued a Policy Information Notice (PIN) entitled "Health Center Emergency 

Management Program Expectations," that detailed the expectations HRSA has for section 330 

grantees related to emergency management ("Health Center Emergency Management Program 

Expectations," Policy Information Notice (PIN), Document Number 2007-15, HRSA, 

August 22, 2007) (Emergency Management PIN). A review of the Emergency Management PIN 

indicates that some of its expectations are very similar to the requirements in this proposed rule. 

Therefore, since the expectations in the Emergency Management PIN are a significant factor in 

determining the burden for FQHCs, we will analyze 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 conduct 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 Clinic Conditions for Certification and the FQHC 

Conditions for Coverage (RHC/FQHC CfCs) already require each RHC and FQHC to assure 

"the safety of patients in case 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 Emergency Management PIN, FQHCs should have 

initiated their "emergency management planning by conducting a risk assessment such as a 

Hazard Vulnerability Analysis" (HVA) (Emergency Management PIN, p. 5). The HVA should 

identify potential emergencies or risks and potential direct and indirect effects on the facility’s 

operations and demands on their services and prioritize the risks based on the likelihood of each 

risk occurring and the impact or severity the facility would experience if the risk occurs 
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(Emergency Management PIN, p. 5). FQHCs are also "encouraged to participate in community 

level risk assessments and integrate their own risk assessment with the local community" 

(Emergency Management PIN, p. 5). 

 Despite these expectations and the existing Medicare regulations for RHCs/FQHCs, some 

RHC/FQHC risk assessments may not comply with all proposed requirements. For example, the 

expectations for FQHCs do not specifically address our proposed requirement to address likely 

medical and non-medical emergencies. In addition, 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 current 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 believe 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 major 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 individuals would attend an initial meeting, review the 

current risk assessment, prepare and forward their comments to the administrator, attend a 

follow-up meeting, perform a final review, 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 comments, develop the new 
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risk assessment, and ensure that the necessary parties approve it. We also expect that the 

administrator would spend more time reviewing the risk assessment than the other individuals. 

 We estimate that it would require 10 burden hours for each RHC to conduct a risk 

assessment that complied with the requirements in this section at a cost of $712. We estimate 

that for all RHCs to comply with our proposed 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 burden hours for each FQHC to conduct a risk 

assessment that complied with our proposed requirements 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 burden hours at a cost of $4,827,360. 

 After conducting the risk assessment, RHCs/FQHCs would have to develop and maintain 

emergency preparedness plans that complied with proposed § 491.12(a)(1) through (4) and 

review and update them annually. It is standard practice for healthcare 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 the 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 plan. However, under this proposed rule, all 

RHCs/FQHCs would have to review their current plans and compare them to their risk 
 305

assessments. The RHCs/FQHCs would need to update, revise, and, in some cases, develop new 

sections to complete their emergency preparedness plans that meet our proposed requirements. 

 The Emergency Management PIN contains many 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 special populations (Emergency Management PIN, 

p. 7). The FQHC’s EMP also should address continuity of operations, as appropriate 

(Emergency Management PIN, p. 6). In addition, FQHCs should use an "all-hazards approach" 

so that these facilities can respond to all of the risks they identified in their risk assessment 

(Emergency Management PIN, p. 6). Based on the expectations in the Emergency Management 

PIN, we expect that FQHCs likely have developed emergency preparedness plans that comply 

with many, if not all, of the elements with which their plans would need to comply under this 

proposed rule. However, we expect that FQHCs 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 FQHCs 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 assessments would be involved in developing the 

emergency preparedness plans. However, we expect that it would require more time to complete 

the plans than the risk assessments. We expect that the administrator would have primary 

responsibility for reviewing and developing the RHC/FQHC’s EMP. We expect that the 

physician, nurse practitioner, and registered nurse 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 estimated 
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56,182 burden hours (14 burden hours for each RHC 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 FQHCs = 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 required to review and update its emergency 

preparedness plan at least annually. We believe that RHCs and FQHCs already review their 

emergency preparedness plans periodically. Thus, compliance with this requirement would 

constitute a usual and customary business practice for RHCs and FQHCs and would not subject 

to the PRA in accordance with 5 CFR 1320.3(b)(2). 

 Proposed § 491.12(b) would require RHCs/FQHCs 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), respectively. We would also 

require RHCs/FQHCs to review and update these policies and procedures at least annually. At a 

minimum, we would require that the RHC/FQHC’s policies and procedures 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 emergencies (§ 491.6(c)). They also must set forth in 

writing their organization’s policies (§ 491.7(a)(2)). In addition, current regulations require that 

a physician, in conjunction with a nurse practitioner 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 policies and procedures, assess whether their policies and procedures 

incorporate their risk assessments and emergency preparedness plans and make any changes 

necessary to comply with our proposed requirements. 

 We expect that FQHCs already have policies 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 supply, water and sanitation, communications, 

transportation, and the access to and security of medical records (Emergency Management PIN, 

p. 6). In addition, FQHCs should also continually 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 integrating their planning with their state and local 

communities’ plans, as well as other key organizations and other relationships (Emergency 

Management PIN, p. 8). Thus, we expect that 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 preparedness policies and procedures. We expect 
 308

that a physician and a nurse practitioner would primarily 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 burden hours at a cost of $968. Based on that estimate, for all 

4,013 RHCs to comply with these requirements 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 expect that FQHCs would have less of a burden from developing 

their emergency preparedness policies and procedures 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. Based 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 FQHCs = 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 all 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 update their emergency preparedness policies 

and procedures at least annually. We believe that RHCs and FQHCs already review their 

emergency preparedness policies and procedures periodically. Therefore, compliance with this 

requirement would constitute a usual 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(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 update these plans at least 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 standard practice for health care facilities to maintain contact 

information for staff and outside sources of assistance; alternate means of communication in case 

there is an interruption in the facility’s phone services; and a method for sharing information and 

medical documentation with other health care providers to ensure continuity 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 emergencies (§ 491.6(c)). We expect that an 

emergency preparedness communication plan would be an essential element in any emergency 

preparedness preparations. However, some RHCs/FQHCs may not have a formal, written 

emergency preparedness communication plan or their plan may not include all the requirements 

we propose. 

 The Emergency Management PIN contains specific expectations for communications and 

information sharing (Emergency Management PIN, 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 policies and procedures for communicating with both 

internal stakeholders (such as patients 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 (Emergency 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 formal 
 310

communication plan for emergencies and that those plans would contain some of our proposed 

requirements. However, we expect that all FQHCs would need to review, revise, and, if needed, 

develop new sections for their emergency preparedness 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 physician to work in conjunction with a nurse 

practitioner or a physician assistant to develop policies, we anticipate that satisfying the 

requirements in this section would require the involvement of the RHC/FQHC’s administrator, a 

physician, and a nurse practitioner or physician assistant. We expect that the administrator and 

the nurse practitioner or physician assistant would be primarily involved in reviewing, revising, 

and if needed, developing new sections for 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 requirements 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 hours for each FQHC x 5,534 FQHCs = 27,670 burden 
 311

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 annually. We believe that RHCs/FQHCs already review their 

emergency preparedness communication plans periodically. Thus, compliance with this 

requirement would constitute a usual 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) would require RHCs/FQHCs to develop and maintain emergency 

preparedness training and testing programs and review and update these 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 existing staff, individuals 

providing services under arrangement, and volunteers, consistent with their expected roles, and 

maintain documentation of that training. Each RHC 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 FQHCs, we expect that all 9,045 RHC/FQHCs 

already have some type of emergency preparedness training program. The current RHC/FQHC 

regulations require RHCs and FQHCs to provide training to their staffs on handling emergencies 

(§ 491.6(c)(1)). In addition, FQHCs are expected 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 expectations for FQHCs address 
 312

initial training and ongoing training, frequency of training, or requirements that individuals 

providing services under arrangement and volunteers be included in the training. RHCs/FQHCs 

would need to review their current training programs; compare their contents to their risk 

assessments, emergency preparedness plans, policies and procedures, and communication plans 

and then take the necessary steps to ensure that their training programs 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 training program is up-to-date and complies with all federal, state, 

and local laws and regulations. This individual would likely be an administrator. We expect that 

the administrator would be primarily involved in reviewing the RHC/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 developing new training materials. We expect 

that the administrator would work with a registered 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 program 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 with this requirement at a cost of $5,021,722 

($526 estimated cost for each RHC/FQHC x 9,547 RHCs/FQHCs = $5,021,722 estimated cost). 

 Proposed § 491.12(d) would also require that RHCs/FQHCs develop and maintain 

emergency preparedness training and testing programs that would be reviewed and updated at 

least annually. We believe that RHCs/FQHCs already review their emergency preparedness 

programs periodically. Therefore, compliance with this requirement would constitute a usual 
 313

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/FQHCs 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 available, RHCs/FQHCs would have to conduct an 

individual, facility-based mock disaster drill at least annually. RHCs/FQHCs would also be 

required to analyze their responses to and maintain documentation of drills, tabletop exercises, 

and emergency events, and revise their emergency plans, as needed. If an RHC or FQHC 

experienced an actual natural or man-made emergency 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 documenting their drills, tabletop exercises, as well 

as any emergency events. 

 Based on our experience with RHCs/FQHCs, we expect that most of the 9,547 

RHCs/FQHCs already conduct some type of testing 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 testing of their EMP at least annually (Emergency 

Management PIN, p. 7). However, we do not believe that all RHCs/FQHCs have the appropriate 

documentation for drills, exercises, and emergency events or that they conduct both a drill and a 
 314

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. Based on this estimate, for all 9,547 RHCs/FQHCs to 

comply with the requirements in this section would require 47,735 burden 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 AND COST ESTIMATES FOR ALL 9,547 

RHC/FQHCS TO COMPLY WITH THE ICRs 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 2,634,972 
 315

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 Participation: Emergency Preparedness (§ 494.62)

 Proposed § 494.62(a) would require dialysis facilities to develop and maintain emergency 

preparedness plans that would have to reviewed and updated at least 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 dialysis facilities to develop a documented, 

facility-based and community-based risk assessment utilizing an all-hazards approach. The risk 

assessment should address the medical and non-medical emergency events the facility could 

experience both within the facility and within the surrounding area. The dialysis 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 dialysis 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 already require dialysis facilities to "implement 

processes and procedures to manage medical and nonmedical emergencies that are likely 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 failure, care-related emergencies, water supply 

interruption, and natural disasters likely to occur in the facility’s geographic area" (§ 494.60(d)). 

Thus, to be in compliance with this CfC, we believe that all dialysis facilities would have already 

performed some type of risk assessment during the process of developing their emergency 
 316

preparedness processes and procedures. However, these risk assessments may not be as 

thorough or address all of the elements required 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 facilities 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 

complied with the requirements of this section. 

 Based on our experience with dialysis facilities, we expect that conducting the risk 

assessment would require the involvement of the dialysis facility’s chief executive officer or 

administrator, medical director, nurse manager, social worker, and a PCT. We believe that all of 

these individuals would attend an initial meeting, review relevant sections of the current 

assessment, develop comments and recommendations for changes to the assessment, attend a 

follow-up meeting, perform a final review and approve the risk assessment. We believe that the 

administrator would probably coordinate the meetings, do an initial review of the current risk 

assessment, provide a critique of the risk assessment, 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 the 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 complying with this requirement to conduct and 

develop a risk assessment would require 12 burden hours at a cost of $838. There are currently 

5,923 dialysis facilities. Therefore, it would require an estimated 71,076 burden hours 

(12 burden hours for each dialysis facility x 5,923 dialysis facilities = 71,076 burden hours) for 

all dialysis facilities to comply with this requirement 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 dialysis 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 facilities 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 preparedness or disaster plan. In addition, 

dialysis facilities must also "implement processes and procedures to manage medical and 

nonmedical emergencies that are likely 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 natural 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 processes and procedures into its emergency preparedness plan. We 

expect that each dialysis facility has some type of emergency preparedness plan and that plan 

should already address many of these requirements. However, all of the dialysis facilities would 

have to review their current plans and compare 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 the dialysis facility would continue to provide 

despite an emergency. The dialysis facility would also need to review, revise, and, in some 
 318

cases, develop delegations of authority or succession plans that the dialysis facility determined 

were necessary for the appropriate 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 dialysis facilities, we 

expect that developing the emergency preparedness plan would require the involvement of the 

dialysis facility’s chief executive officer or administrator, medical director, nurse manager, social 

worker, and a PCT. We believe that all of these individuals would probably have to attend an 

initial meeting, review relevant sections of the facility’s current emergency preparedness or 

disaster plan(s), develop comments 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 probably coordinate the meetings, do an initial review of the current 

risk assessment, provide a critique of the risk assessment, offer 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, medical director, and nurse 

manager would probably spend more time reviewing 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 relevant sections of it. In addition, since the medical director’s 

responsibilities include participation in the development of patient care policies and procedures 

(42 CFR 494.150(c)), we expect that the medical director would be involved in the development 

of the emergency preparedness plan. We estimate 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 for 
 319

each dialysis facility x 5,923 dialysis facilities = 59,230 burden hours) to complete the plan at a 

cost of $4,596,248 ($776 estimated cost for each dialysis facility x 5,923 dialysis facilities = 

$4,596,248 estimated cost). 

 Each dialysis facility would also be required to review and update its emergency 

preparedness plan at least annually. We believe that dialysis facilities already review their 

emergency preparedness plans periodically. The current 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 procedures based on the emergency plan, the risk 

assessment, and communication plan as set forth 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 interruptions, and natural and man-made disasters that 

are likely to occur in the facility’s geographical area. Dialysis facilities would also have to 

review and update these policies and procedures at least annually. 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) already require dialysis facilities to have and 

"implement processes and procedures to manage medical and nonmedical emergencies . . . [that] 

include, but not limited to, fire, equipment or power failures, care-related emergencies, water 
 320

supply interruption, and natural disasters likely to occur in the facility’s geographic area". In 

addition, we expect that dialysis facilities already have procedures that would satisfy some of the 

requirements in this section. For example, each dialysis facility is already 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 comply with these requirements. We expect the 

administrator, medical director, and the nurse manager would be primarily involved with 

reviewing, revising, and if needed, developing any new policies and procedures that were 

needed. The remaining individuals would likely review the sections of the policies and 

procedures that directly affect their areas of expertise. Therefore, we estimate 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 for each dialysis facility x 5,923 dialysis facilities = 59,230 burden hours) to 

complete the plan at a cost of $4,596,248 ($768 estimated cost for each dialysis facility x 5,923 

dialysis facilities = $4, 596,248 estimated cost). 

 The dialysis facility must also review and update its emergency preparedness policies and 

procedures at least annually. We believe that dialysis facilities already review their emergency 

preparedness policies and procedures periodically. In addition, the current CfCs already require 
 321

(at 42 CFR 494.150(c)(1)) the medical director to participate 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 facilities 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 review and update this plan at least annually. The communication plan 

must include the information listed at § 494.62(c)(1) through (7). 

 We expect that all dialysis facilities have some type of emergency preparedness 

communication plan. A communication plan would be an integral part of any emergency 

preparedness plan. Current CfCs already require dialysis facilities to have a written disaster plan 

(42 CFR 494.60(d)(4)). Thus, each dialysis facility should already 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; alternate 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 facilities would need to review, update, and in some cases, develop new sections 

for their plans to ensure that those plans included all of the previously-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 requirements. Based upon our experience with dialysis 

facilities, we anticipate that satisfying these requirements would primarily require the 

involvement of the dialysis facility’s administrator, medical director, and nurse manager. For 

each dialysis facility, we estimate that complying with this requirement would require 4 burden 

hours at a cost of $357. Therefore, for all of the dialysis facilities to comply with this 

requirement would require an estimated 23,692 burden hours (4 burden hours for each dialysis 

facility x 5,923 dialysis facilities = 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 the purpose of determining the burden for this 

requirement, we would expect that dialysis facilities would review their emergency preparedness 

communication plans annually. We believe that all dialysis facilities have an administrator that 

would be primarily responsible for the day-to-day operation 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 federal, state, and local laws, regulations, and ordinances. We 

expect that the administrator would be responsible for periodically reviewing the dialysis 

facility’s plans, policies, and procedures as part of his or her work responsibilities. 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 require dialysis facilities to develop and maintain emergency 

preparedness training, testing and patient orientation programs that would have to be evaluated 
 323

and updated at least annually. The dialysis facility would have to comply with the requirements 

located at § 494.62(d)(1) through (3). 

 Proposed § 494.62(d)(1) would require that dialysis facilities provide initial training in 

emergency preparedness policies and procedures 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 dialysis facility would have to provide 

emergency preparedness training at least annually. 

 Current CfCs already require dialysis facilities to "provide training 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 instruction would have to include the same matters that are specified in 

the current CfCs (42 CFR 494.60(d)(2)). Thus, dialysis facilities should already have an 

emergency preparedness training program for new 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 contents to their updated emergency preparedness 

programs, that is, the risk assessment, emergency 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 this requirement would be the time and effort 

necessary to develop the required training program. 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 responsibilities include, among other things, staff 
 324

education and training (42 CFR 494.150(b)). We estimate that it would require 7 burden hours 

for each dialysis facility to develop an emergency training program at a cost of $559. Therefore, 

it would require an estimated 41,461 burden hours (7 burden hours for each dialysis facility x 

5,923 dialysis facilities = 41,461 burden hours) to comply with this requirement at a cost of 

($559 estimated cost for each dialysis facility x 5,923 dialysis facilities = $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. Therefore, 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(d)(2) requires dialysis facilities to participate 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 would have to conduct an individual, facility-based 

mock disaster drill at least annually. If the dialysis facility experienced an actual 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 event. Dialysis facilities would also 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 develop 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 expect that all dialysis 

facilities are already conducting some type of tests to evaluate their emergency plans. Although 

the current CfCs do not specify the 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 customary 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 dialysis facilities to provide appropriate 

orientation and training to patients, including the areas specified in proposed § 494.62(d)(1). 

Proposed § 494.62(d)(1) specifically would require that staff demonstrate knowledge of 

emergency procedures including the emergency information 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 AND COST ESTIMATES FOR ALL 5,923 

DIALYSIS FACILITIES TO COMPLY WITH THE ICRs CONTAINED 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 year’s burden for complying with all of the 

requirements in this proposed rule would be 3,018,124 burden hours at a cost of $185,908,673. 

For subsequent years, if there is any additional burden, it would be negligible. 

To obtain copies of the supporting statement and any related forms for the proposed 

paperwork collections referenced earlier, access CMS’ Web site at 

http://www.cms.gov/PaperworkReductionActof1995/PRAL/list.asp#TopOfPage or email your 

request, including your address, phone number, OMB number, and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the Reports Clearance Office at 410-786–1326. 

 If you comment on these information collection and recordkeeping requirements, please 

mail copies directly to the following: 

Centers for Medicare & Medicaid Services, 

Office of Strategic Operations 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, distributive impacts, and equity). 

In response to past terrorist attacks, natural disasters, and the subsequent national need to 

refine the nation’s strategy to handle emergency situations, there continues to be a coordinated 

effort across federal agencies to establish a foundation for development and expansion of 

emergency preparedness systems. There are two Presidential Directives, HSPD-5 and HSPD-21, 

instructing agencies to coordinate their emergency preparedness activities with each other. 

Although these directives do not specifically require Medicare providers and suppliers to adopt 

measures, they have set the stage for what we expect from our providers and suppliers in regard 

to their roles in a more unified emergency preparedness system. 

Homeland Security Presidential Directive (HSPD-5): Management of Domestic 

Incidents authorizes the Department of Homeland to develop and administer the National 

Incident Management System (NIMS). 

Homeland Security Presidential Directive (HSPD-21) addresses public health and 

medical preparedness. The directive establishes a National Strategy for Public Health and 

Medical Preparedness (Strategy), which builds upon principles set forth in “Biodefense for the 

21st Century (April 2004), “National Strategy for Homeland Security” (October 2007), and the 

“National Strategy to Combat Weapons of Mass Destruction” (December 2002). The directive 
 328

aims to transform our national approach to protecting 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 Planning and Review (September 30, 1993), Executive Order 13563 

on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility 

Act (RFA) (September 19, 1980, Pub. L. 96-354), section 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 (including potential economic, environmental, public health and 

safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be 

prepared for major rules with economically significant 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 reported that the Louisiana Attorney General 

investigated approximately 215 deaths that occurred in hospitals and nursing homes following 

Katrina. Since nearly all hospitals and nursing homes are certified to participate 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 disaster of equal magnitude. Katrina is an extreme 

example of a natural disaster, so we also considered other more common disasters. The United 
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States experiences numerous natural disasters annually, including, in particular, 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 result of tornadoes 

(http://www.spc.noaa.gov/wcm/ustormaps/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 Hazards—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 quantify the number of lives saved as a result of this proposed rule, all of 

the data we have read regarding emergency preparedness indicate that implementing the 

requirements in this proposed rule could have a significant impact on protecting the health and 

safety of individuals served by providers and suppliers 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 with 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 suppliers to conduct a risk assessment, to develop an emergency 

preparedness 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 disaster. 
 330

We believe that this proposed rule would be an economically significant regulatory action 

under section 3(f)(1) of Executive Order 12866, since it may lead to impacts of greater than 

$100 million in the first year following the rule’s effective date. 

This proposed rule would establish a regulatory framework with which Medicare- and 

Medicaid-participating providers and suppliers would have to comply to ensure that the varied 

providers and suppliers of healthcare are adequately prepared 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 factors are discussed under section III. of this 

proposed rule (Collection of Information Requirements). In addition, we have used the same 

data source for the RIA that we used to develop the PRA burden estimates, 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 regulatory relief of small businesses if a rule has a 

significant impact on a substantial number of small entities. The Act generally defines a “small 

entity” as: (1) a proprietary firm meeting the size standards of the Small Business Administration 

(SBA); (2) a not-for-profit organization that is not dominant in its field; or (3) a small 

government jurisdiction with a population of less than 50,000. States 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 entities 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 entities. For purposes of the RFA, 
 331

we estimate that most hospitals and most other providers 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 considered 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 than $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 the Social Security Act requires us to prepare a regulatory 

impact analysis if a rule may have a significant impact on the operations of a substantial number 

of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. 

For purposes of section 1102(b) of the Act, we define 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 than $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 Reform Act of 1995 (UMRA) requires that 

agencies assess anticipated costs and benefits before 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 approximately $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 this 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 entities would be required to make changes in their operations. This 
 332

proposed rule would not mandate any new requirements for state, local or tribal governments. 

For the private sector facilities, this regulatory impact section constitutes the analysis required 

under UMRA. 

Executive Order 13132 establishes certain requirements that an agency must meet when it 

develops a proposed rule (and subsequent final rule) that imposes substantial direct requirement 

costs on state and local governments, preempts 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 Medicaid-participating 

providers and suppliers discussed in previous sections to perform a risk analysis; establish an 

emergency preparedness plan, emergency preparedness policies and procedures, and an 

emergency preparedness communication plan; train staff in emergency preparedness, and test the 

emergency plan. The economic impact would differ between hospitals and the various other 

providers and suppliers, depending upon a variety of factors, including existing regulatory 

requirements and accreditation standards. 

We discuss the economic impact for each provider and supplier type included in this 

proposed rule in the order in which 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 the 
 333

Collection of Information Requirements section of this proposed rule. We provide a chart at the 

end of the RIA section of the total regulatory impact for each provider/supplier. 

As stated in the ICR section, we obtained all salary information from the May 2011 

National Occupational Employment and Wage Estimates, United States by the Bureau of Labor 

Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm and calculated the added value of 

benefits using the estimation that 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 shelter 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 sanitary storage of such provisions. 

Based on our experience, we expect inpatient providers to currently have food, water, and 

supplies, alternate sources of energy to provide 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 failures. Thus, we believe that this requirement 

is a usual and customary business practice for inpatient providers and we have not assigned any 

impact for this requirement. 

Further, we expect that most providers have agreements with 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 affects the primary vendor. We considered proposing a 

requirement that providers must keep a larger quantity of food and water on hand in the event of 
 334

a disaster. However, we believe that a provider should have the flexibility to determine what is 

adequate based on the location and individual characteristics 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 stockpiling 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 volunteers, visitors, and individuals 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 systems 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 minimize 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 have not assigned any additional 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 continuous hours every 12 months at 100 percent of 
 335

the power load the hospital anticipates it will require 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 generator testing every 

36 months to provide reasonable assurance emergency power systems are capable of running 

under load during an emergency. In order to provide further assurance that generators will be 

capable of operating during an emergency, 4 hours of continuous generator testing will be 

required every 12 months. We have also proposed the same emergency and standby power 

requirements for CAHs and LTC facilities. 

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

Based on information from the U.S. Bureau of Labor Statistics and the U.S. Energy Information 

Administration, we have calculated the cost for the generator 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 costs in light of the existing LSC and other state 

and federal requirements. 

D. Condition of Participation: Emergency Preparedness 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 RHNCIs to conduct a paper-based, tabletop 

exercise at least annually. RHNCIs must analyze 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 this requirement would be limited to the staff 

time needed to participate in the tabletop exercises. We estimate that approximately 4 hours of 

staff time would be required of the administrator and director of nursing, and 2 hours of staff 

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

residents to alternate sites. We believe that other staff members would be required to spend a 

minimal amount of time during these exercises and such staff time would be considered a part of 

regular on-going training for RHNCI staff. We estimate that it would require 10 hours of staff 

time for each of the 16 RNHCIs to conduct exercises at a cost of $330. Therefore, it would 

require an estimated total impact of $5,280 each year after the initial year 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 RNHCIs 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 facility-based mock disaster drill at least annually and maintain 
 337

documentation of all mock disaster drills. ASCs 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 integral to providing the early recognition and response necessary for 

minimizing the effects of catastrophic public health 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 area of public health emergency preparedness and response: the 

Centers for Public Health Preparedness (CPHP), the Bioterrorism Training and Curriculum 

Development Program (BTCDP), and National 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 Security, to assist them in complying with this 

proposed requirement. Thus, we believe 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 that appreciable staff time would be required of the administrator 

and risk assurance nurse. We believe that other staff members would be required to spend a 

minimal amount of time during these exercises and the training would 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 participate in the disaster 

drills (3 hours to participate 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 8 hours 

for an estimated cost of $500 for each of the 5,354 ASCs and a total cost estimate of $2,677,000 
 338

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 Preparedness 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 addition, hospices are to conduct a paper-based, 

tabletop exercise at least annually. We believe that the administrator 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 the assistance of one member of the IDG. We 

believe that the registered nurse would most likely represent the IDG on the drills and exercises. 

While we expect that all staff would be involved in the drills and exercises, we would consider 

their involvement as part of their regular staff training. However, for the purpose of this analysis 

we assume that the administrator would spend approximately 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 tabletop exercise. Thus, we estimate 

that each hospice would spend $388. The total estimate for all hospices 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 Residential Treatment Facilities (PRTFs)--Training 

and Testing (§ 441.184(d))

 Proposed § 441.184(d)(2)(i) through (iii) would 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 required to conduct a facility-based 

mock disaster drill. We estimate that the cost associated with this requirement is the time that it 

would take key personnel to participate 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 participate (3 hours to participate 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 total 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 the 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 paper-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 economic impact hours to be 2 hours for each PACE 

organization (total impact hours=182) at an estimated cost of $90 for each organization. The 
 340

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 requirements 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 develop 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 national 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 needs of an affected population in the event of a disaster. The SNS 

has large quantities of medicine and medical supplies to protect the American public if there is a 

public health emergency (for example, a terrorist attack, flu outbreak, or earthquake) severe 

enough to cause local supplies to run out. After federal and local authorities agree that the SNS 

is needed, medicines can be delivered to any state in the U.S. within 12 hours. Each state has 

plans to receive and distribute SNS medicine and medical supplies to local communities as 
 341

quickly as possible. States have the discretion to decide where to distribute the supplies in the 

event of multiple events. 

However, prudent emergency planning requires that some supplies be maintained inhospital for immediate needs. The Federal Metropolitan Medical Response System (MMRS) 

guidelines call for MMRS communities to be self-sufficient for 48 hours. We encourage 

hospitals to work with stakeholders (state boards of pharmacy, pharmacy organizations, and 

public health organizations) for guidance and assistance 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. After such time, supplies could be 

replenished from the SNS and other federal agencies. 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 care facilities, we expect that all health care facilities provide some type 

of training to all personnel, including those providing services under contract or arrangement and 

volunteers. Since such training is required for the TJC-accredited hospitals, the proposed 

requirements for developing an emergency preparedness-training program and the materials they 

plan to use in providing initial and on-going annual training would constitute a usual and 

customary business practice for TJC-accredited hospitals. 

However, under this proposed rule, non TJC-accredited hospitals would need to review 

their existing training program and appropriately revise, update, or develop new sections and 

new material for their training program. The economic impact associated with this requirement 
 342

is the staff time required for non-TJC accredited hospitals to review, update or develop a training 

program. We discuss the economic impact for 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-based, tabletop exercise at least annually. 

State, tribal, territorial, and local public health and medical systems comprise a critical 

infrastructure that is integral in providing early recognition and response necessary for 

minimizing the effects of catastrophic public health 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 four programs at HHS addressing 

education and training in the area of public health emergency preparedness and response. The 

programs are the Centers for Public Health Preparedness (CPHP), The Bioterrorism Training and 

Curriculum Development Program (BTCDP), and National Laboratory Training Network 

(NLTN). As discussed earlier in this preamble, hospitals can use 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 facility-based disaster 

drills, and the tabletop exercises. We believe that appreciable staff time would be required of the 

risk management director, facilities 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 for hospital staff. We 

estimate that the risk management director, facilities director, safety director and security 
 343

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 hospital. Therefore, for all non TJC-accredited 

hospitals to comply with this requirement would require 72,864 total economic impact hours 

(48 economic impact hours per non TJC-accredited hospital x 1,518 non TJC-accredited 

hospitals = 72,864 total economic impact hours) at an estimated total cost of $5,100,480 ($3,360 

per non TJC-accredited hospital x 1,518 hospitals = $5,100,480). 

 Based on TJC’s standards, the TJC-accredited hospitals are currently required to test their 

emergency operations plan twice a year. Therefore, for TJC-accredited hospitals to conduct 

disaster drills and tabletop exercises would constitute a usual 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 minimum of 4 continuous hours at least once every 

12 months under a full electrical load anticipated to be required during an emergency. The intent 

of this requirement is to provide an increased assurance that a generator and associated essential 

electrical systems will function during an emergency 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 require accredited hospitals to test their generators/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 calculation for accredited hospitals. 
 344

However, under this proposed rule, non-accredited 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-accredited hospitals. 

Thus for non-accredited hospitals, we estimate the total 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 accredited hospitals) for accredited 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: Emergency Preparedness for Transplant Centers

There is no additional economic impact to discuss in this section for transplant centers. 

All transplant centers are located within a hospital 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 Long Term Care (LTC) Facilities

1. Subsistence (§ 483.73(b)(1)) 

 Section § 483.73(b)(1) would require LTC facilities to provide subsistence needs for staff 

and residents, whether they evacuate or shelter 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 section, 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 responsibility 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 material in the event of multiple events. 

We expect that a 1- to 2-day supply would be sufficient because 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 not assign a cost to this 

requirement. 

 We encourage LTC facilities to work with stakeholders (State Boards of Pharmacy, 

pharmacy organizations, and public health organizations) 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 require LTC facilities to participate in or 

conduct a mock disaster drill and a tabletop exercise at least annually. The current requirements 

for LTC facilities already mandate that these facilities 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 annual community or facility-wide mock disaster 

drill and tabletop would constitute 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 every 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 Intellectual 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, tabletop exercise at least annually. The current 

ICF/IID CoPs require them to conduct evacuation drills at least quarterly for each shift and under 

varied conditions to evaluate the effectiveness of emergency and disaster plans and procedures" 

(42 CFR 483.470(i) and (i)(iii)). In addition, ICFs/IID must evacuate 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, including accidents, and take corrective action 
 347

(42 CFR 483.470(i)(2)). Thus, all 6,450 ICFs/IID already conduct quarterly drills. We estimate 

that any additional economic impact for an ICF/IID 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 discussed in the COI section. 

M. §484.22 Condition of Participation: Emergency Preparedness for Home Health Agencies 

(HHAs)--Training and Testing (§ 484.22(d)) 

 We discuss the majority of the economic impact for this requirement in the COI section 

which is estimated to be $48,725,629. 

 Proposed § 484.22(d)(2)(i) through (iii) would 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 all mock disaster drills. We would also require 

the HHA to maintain documentation of the exercises. 

There are currently two programs at HHS addressing education and training in the area of 

public health emergency preparedness and response: the Centers for Public Health Preparedness 

(CPHP), and National Laboratory 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 Security, to assist them in complying with this 

requirement. Thus, we believe 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 that appreciable staff time would be required 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 training 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 the director of training would 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 anticipate 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 estimated 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: Comprehensive Outpatient Rehabilitation 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, tabletop exercise at least annually and document the 

drills and exercises. To comply with this requirement, 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 all aspects of disaster preparedness (42 CFR 485.64(b)(1)). Thus, for the 

purpose of this analysis, we believe that CORFs would incur minimal 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 Preparedness 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 tabletop exercises. Accredited CAHs are currently 

required to conduct such drills and exercises. Although we believe that non-accredited CAHs 

are currently participating 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 resources 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 tabletop exercises. We believe that appreciable staff time would be 

required of the administrator, facilities director, director of nursing and nursing education 

coordinator. We believe that other staff members would be required to spend a minimal amount 

of time during these exercises that would be considered as part of regular on-going training for 

hospital staff. We estimate that the administrator, facilities director, and the director of nursing 

would spend approximately a total of 20 hours on an annual basis to participate 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 requirement, it would require 18,400 total economic impact 

hours (20 economic impact hours per non-accredited 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 every 12 months. AO’s, including TJC, DNV, and 

HFAP; currently require accredited CAHs to test their generators/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 calculation for accredited CAHs. However, under this 

proposed rule, non-accredited CAHs 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 CAHs, we estimate labor cost to be $139,721 (6 hours x $25.45/hr 

($152.70) x 915 non-accredited CAHs). We estimate 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 cost 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 accredited 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 Preparedness for Clinics, Rehabilitation Agencies, and 

Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language 

Pathology ("Organizations")--Testing (§ 485.727(d)(2)(i) through (iii)) 

 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. Rehabilitation Agencies would need to review their current 

activities and make minor adjustment to ensure that they comply 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 impact of this rule on these organizations would 

be limited to the estimated ICR burden of $6,939,456. 

Q. Condition of Participation: Emergency Preparedness 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, tabletop exercise at least annually. We estimate that to comply 

with the requirement to participate in a community mock disaster drill or to conduct an 

individual facility-based mock drill and a tabletop exercise annually would primarily require the 

involvement of the administrator and a registered nurse. We estimate that the administrator 

would spend approximately 4 hours to participate in a community or facility-wide drill and 

1 hour to participate in a tabletop drill. We also 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 for all 207 CMHCs would be 1656 (8 impact hours 
 352

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 Preparedness for Organ Procurement Organizations 

(OPOs)--Training and Testing (§ 486.360(d)(2)(i) through (iii))

 The OPO CfCs do not currently contain a requirement for OPOs to conduct mock disaster 

drills or paper-based, tabletop exercises. We estimate that these tasks would require the quality 

assessment and performance improvement (QAPI) director and the education coordinator to each 

spend 1 hour to participate in the tabletop exercise. Thus, the total annual economic impact 

hours for each OPO would be 2 hours. The total cost would be $107 for a (QAPI coordinator 

hourly salary and the Education Coordinator to participate in the tabletop 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 Certification 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 centers that could provide shelter during an 

emergency. 

 We propose that an RHC/FQHC must review 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/FQHCs would review their emergency preparedness 
 353

policies and procedures annually. Based on our experience with Medicare providers and 

suppliers, health care facilities generally have a compliance officer or other staff member who 

reviews the facility’s program periodically to ensure that it complies with all relevant federal, 

state, and local laws, regulations, and ordinances. We believe that complying with the 

requirement for an annual review of the emergency 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) through (iii) would require RHCs/FQHCs to participate in a 

community or facility-wide mock disaster drill and a tabletop exercise at least annually. We 

have stated previously that FQHCs are currently required to conduct annual drills. We believe 

that for FQHCs to comply with these requirements would constitute a minimal economic impact, 

if any. Thus, we are estimating the economic impact for RHCs to comply with these 

requirements to conduct mock drills and tabletop 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 drills (3 hours to participate 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 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 Preparedness for End-Stage Renal Disease Facilities 

(Dialysis Facilities)--Testing (§ 494.62(d)(2)(i) through (iv))

Proposed § 494.62(d)(2) would require dialysis facilities to participate in or conduct a 

mock disaster drill and a paper-based, tabletop exercise at least annually. The current CfCs 

already require dialysis facilities to evaluate their emergency preparedness plan at least annually 

(§ 494.60(d)(4)(ii)). Thus, we expect that all dialysis facilities are already conducting some type 

of tests to evaluate their emergency 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 analysis, 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 the 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 the 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 total first-year cost of $225,268,957. 

TABLE 19--TOTAL ESTIMATED COST FROM 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 85,905
 356

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 policies and procedures, development and maintenance 

of communication plans, disaster training and testing, and generator testing (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 disaster, there would be associated increases in provision of dialysis 

services, thus entailing labor, material and other costs. As discussed in the next section (“Benefits of 

the Proposed Rule”), it is difficult to predict how disaster 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 request comments and data regarding this issue. 

Moreover, we have not estimated any costs for generator backup, on the assumption that such 

backup is already required for virtually all inpatient and many outpatient facilities, either for TJC or 

other accreditation, or under state or local codes. We request information on this assumption and in 

particular on any situations or provider types for which this could turn out to be unnecessarily costly.

V. Benefits of the Proposed Rule

 The U.S. Department of Health and Human Services, in its Program Guidance for 

emergency preparedness grants, stated, "as frontline entities in response to mass casualty 

incidents, hospitals and other healthcare providers such as health centers, rural hospitals and 

private physicians will be looked to for minimizing the loss of life and permanent disabilities. 
 357

Hospitals and other healthcare provider organizations must be able to work not only inside their 

own walls, but also as a team during an emergency to respond efficiently. Hospitals currently, 

either through experience or empirical 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 anywhere 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 ensure 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 one 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 people 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 might not be as large or 

larger, as illustrated by the tsunami that hit Japan in 2011. 

 In the event of such disasters, vulnerable populations are at greatest risk for negative 

consequences from healthcare disruptions. According to one study, children and adolescents 

with chronic conditions are at increased risk of adverse outcomes following a natural disaster 

(Rath, Barbara, et. al. “Adverse Health Outcomes after Hurricane Katrina among Children and 

Adolescents with Chronic Conditions” 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 Patient 
 358

Care in Disasters: Lessons from the Hurricanes and Earthquake of 2005” Clin J Am Soc 

Nephrol 2:814-824, 2007.) Individuals 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 Hurricane 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 Failure 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 New 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 require ongoing medical treatment during disasters are 

required to visit emergency departments for treatment and/or hospitalization. Emergency 

department visits incur a copay for most beneficiaries. Similar costs are also incurred by patients 

for hospitalizations. The literature shows that natural catastrophes disproportionately affect ill 

and socioeconomically disadvantaged populations that are most at risk (Abdel-Kader K, Unrah 

ML. Disaster and end-stage renal disease: targeting vulnerable patients for improved outcomes. 

Kidney Int. 2009;75:1131-1133; Zoraster R, Vanholder R, Sever MS. Disaster management of 

chronic dialysis patients. Am J Disaster Med. 2007;2(2):96-106; and Redlener 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 planning improves disaster response. In 2007, Modern Healthcare

reported on a healthcare system’s response to encroaching wildfires in California. Staff from a 

San Diego hospital and adjacent nursing facility transported 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 that 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 providers and suppliers to conduct a 

risk assessment, to develop an emergency preparedness 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 disaster. 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 the risk of mortality and morbidity associated 

with disasters. We believe it very 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 potential natural or manmade disasters. We have 

not prepared an estimate in either quantitative or dollar terms of the potential life-saving benefits 
 360

of this proposed rule. There are several reasons for this, most notably 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 provides the number of Medicare FFS beneficiaries 

receiving services from some of the provider types affected by this proposed rule during the 

month of July 2013. We are unable to provide volume data for those patients in Medicare 

Advantage plans or the Medicaid population. However, one could assume the July 2013 

summary is representative of an average month during the year. In the event of a disaster, the 

fee-for-service patients represented in Table 20 could 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 disaster planning would not only accrue to individuals requiring 

health care services. Health care facilities themselves may benefit from improved ability to 

maintain or resume delivering services. After Hurricane Katrina, 94 dialysis facilities closed for 
 361

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 Hospitals Corporation was due to lost revenue. Lost 

revenue from Long Beach Medical Center hospital and nursing home was estimated at $1.85 

million a week after closing due to damage from hurricane Sandy 

(http://www.modernhealthcare.com/article/20121208/MAGAZINE/312089991#ixzz2adUDjFIE?

trk=tynt). 

 Finally, taxpayers and insurance companies 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 their usual facility was, on average, $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 reimbursed 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 Medicare, Medicaid or private insurance is also 

increased. AHRQ’s Medical Expenditure Panel 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 Characteristics 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_files/publications/st318/stat318.pdf). 
 362

 With the annualized costs of the rule’s emergency preparedness requirements estimated 

to be approximately $80 million depending on the discount rate used (see the accounting 

statement table that follows) and the rule generating additional, unquantified costs associated 

with the life-saving activities that become implementable 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. Preliminary results have identified increases in ESRD 

treatment disruptions, emergency department visits, hospitalizations, and 30-day mortality for 

ESRD patients living in the areas affected by the storm. This analysis supports other research 

and experience that clearly demonstrates a relationship between dialysis disruptions and higher 

rates of adverse events. Adoption of the requirements in this proposed rule would better enable 

individual facilities to: anticipate threats; rapidly 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 reduce 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 quantify 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 Medicare and Medicaid providers and suppliers addressing 
 363

emergency and disaster preparedness are insufficient 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 Secretary for Preparedness 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 emergency 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 Healthcare Executives (ACHE), less than 1 percent of 

hospital CEOs identified “disaster preparedness” as a top priority. Also, a 2012 survey of 1,202 

community hospital CEOs (found at: http://www.ache.org/Pubs/Releases/2013/Top-IssuesConfronting-Hospitals-2012.cfm) of ASPR’s Hospital Preparedness Program (HPP) showed that 

disaster preparedness was not identified as a top issue. We believe that absent conditions of 

participation/certification/coverage, providers and suppliers would not consistently adhere to the 

various local, state and federal emergency preparedness 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 impossible to determine consistently across providers. 

Such inconsistent application of local, state, and federal requirements could compound the 

problems faced by governments, health care organizations, and citizens during a disaster. In 
 364

addition, CMS regulations would enable CMS to survey and enforce the emergency 

preparedness requirements using standard processes and criteria. 

3. Back-up power for Outpatient Facilities 

 A potential regulatory alternative would involve 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 example, preservation of refrigerated drugs and 

biologics, and the potential costs of replacing such items if power is not maintained for the 

duration of the emergency. For example, the current backup power would normally be expected 

to last for hours, not days. 

4. Outpatient Tracking Systems 

 Under another regulatory alternative, we would require facilities to have systems in place 

to keep track of outpatients; the benefits of this alternative 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, would it even be possible, 

and if so using what methods, for a hospital outpatient facility, an ESRD clinic, a Community 

Mental Health Center, or an FQHC to attempt to track patients? We would 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 preparedness—covering one or a subset of provider 

classes to learn from implementation prior to extending the rule to all groups. 

• A phase in approach— implementing the requirements 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 after the final rule is published. 

• Variations of the primary requirements—for example, we have proposed requiring 

two annual training exercises—it would be instructive to receive public feedback on whether 

both should be required annually, semiannually, or if training should be an annual or semiannual 

requirement. 

• Integration with current requirements-- we are soliciting comment on how the 

proposed requirements will be integrated with/satisfied by existing policies and procedures 

which regulated entities may have already adopted. 

6. Conclusion 

 We currently have regulations for Medicare and Medicaid providers and suppliers to 

protect the health and safety of Medicare beneficiaries and others. We revise these regulations on 

an as-needed basis to address changes in clinical practice, patient needs, and public health issues. 

The responses to the various past disasters demonstrated that our current regulations are in need 

of improvement in order to protect patients, residents, and clients during an emergency and that 

emergency preparedness for health care providers and suppliers is an urgent public health issue.

Therefore, we are promulgating emergency preparedness requirements that will be 

consistent and enforceable for all Medicare and Medicaid providers and suppliers. This 

proposed rule addresses the three key elements needed to ensure that health care is available 

during emergencies: safeguarding human resources, ensuring business continuity, and protecting 
 366

physical resources. Current regulations for Medicare and Medicaid providers and suppliers do 

not adequately address these key elements. 

X. Accounting Statement

As required by OMB Circular 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 saved 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* 

Annualized 86 2013 7% 2014 - 2018 

Monetized 

($million/year) 83 2013 3% 2014 - 2018 

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

*The cost estimation is adjusted from 2011 to 2013 year dollars using the CPI-W published by Bureau 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-health, Infants and children, Medicaid, Penalties, 

Reporting and recordkeeping requirements. 

42 CFR Part 460 

Aged, Health care, Health records, Medicaid, Medicare, Reporting and recordkeeping 

requirements. 

42 CFR Part 482 

Grant programs-health, Hospitals, Medicaid, Medicare, Reporting and recordkeeping 

requirements. 

42 CFR Part 483 

Grant programs-health, Health facilities, Health 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 facilities, 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 facilities, Medicaid, Medicare, Reporting and 

recordkeeping requirements, Rural areas. 

42 CFR Part 494 

Health facilities, Incorporation by reference, Kidney diseases, Medicare, Reporting and 

recordkeeping requirements. 
 369

For the reasons set forth in the preamble, the Centers for Medicare and 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) through (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 Institution (RNHCI) must comply with all 

applicable Federal and State emergency preparedness requirements. The RNHCI 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 RNHCI must develop and maintain 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 
 370

assessment, utilizing an all-hazards approach. 

 (2) Include strategies for addressing emergency events identified by the risk assessment. 

(3) Address patient population, including, but not limited to, persons at-risk; the type of 

services the RNHCI 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 cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, including documentation of the RNHCI’s 

efforts to contact such officials and, when applicable, of its participation 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 section, 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 energy 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, extinguishing, and alarm systems. 
 371

(D) Sewage and waste disposal. 

 (2) A system to track the location of staff and patients in the RNHCI’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 communication with external sources of assistance. 

 (4) A means to shelter in place for patients, 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 secure 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 cessation of operations to ensure 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 provision of care at an alternate care site identified 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 services under agreement. 

(iii) Next of kin, guardian or custodian. 

(iv) Other RNHCIs. 

(v) Volunteers. 

 (2) Contact information for the following 

(i) Federal, State, tribal, regional, and local emergency preparedness staff. 

(ii) Other sources of assistance. 

 (3) Primary and alternate means for communicating with the following: 

(i) RNHCI’s staff. 

(ii) Federal, State, tribal, 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 patient or his or her legal representative. 

 (5) A means, in the event of an evacuation, 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 must be reviewed and updated at least annually. 

 (1) Training program. The RNHCI must do all of the following: 

(i) Initial training in emergency preparedness policies and procedures to all new and 

existing staff, individuals providing services under arrangement, and volunteers, consistent with 

their expected roles. 

(ii) Provide emergency preparedness training at least annually. 

(iii) Maintain documentation of all emergency preparedness training. 

(iv) Ensure that staff can demonstrate 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 tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, 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 416 continues to read as follows: 

Authority: Secs. 1102 and 1871 of the Social Security 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 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 emergency events identified by the risk assessment. 

 (3) Address patient population, including, but not limited to, the type of services the 

ASC 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 cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, 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) of 
 375

this section, risk assessment at paragraph (a)(1) of this section, 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 staff and patients in the ASC’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 communication 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 documentation that does the following: 

(i) Preserves patient information. 

(ii) Protects confidentiality of patient information. 

(iii) Ensures records are secure and readily available. 

(5) The use of volunteers in an emergency and other staffing strategies, 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 declared by the Secretary, in accordance with 
 376

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 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 services under arrangement. 

(iii) Patients’ physicians. 

(iv) Other ASCs. 

(v) Volunteers. 

 (2) Contact information for the following: 

(i) Federal, State, tribal, regional, and local emergency preparedness staff. 

(ii) Other sources of assistance. 

 (3) Primary and alternate means for communicating with the following: 

(i) ASC’s staff. 

(ii) Federal, State, tribal, 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 evacuation, to release patient information as permitted 

under 45 CFR 164.510. 

 (6) A means of providing information about the general condition and location of 
 377

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 jurisdiction the Incident Command Center, or designee. 

 (d) Training and testing. The ASC must develop and maintain an emergency 

preparedness training and testing program that must be reviewed and updated at least annually. 

 (1) Training program. The ASC must do all of the following: 

(i) Initial training in emergency preparedness policies and procedures to all new and 

existing staff, individuals providing on-site services under arrangement, and volunteers, 

consistent with their expected roles. 

(ii) Provide emergency preparedness training at least annually. 

(iii) Maintain documentation of all emergency preparedness training. 

(iv) Ensure that staff can demonstrate 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 disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at 

least annually. 

 (ii) If the ASC experiences an actual natural 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 following the onset of the actual event. 

(iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, or prepared questions designed to challenge 
 378

an emergency plan. 

 (iv) Analyze the ASC’s response to and maintain documentation of all drills, tabletop 

exercises, and emergency events and revise the ASC’s emergency plan, as needed. 

PART 418-- HOSPICE CARE 

7. The authority citation for Part 418 continues to read as follows: 

Authority: Secs. 1102 and 1871 of the Social Security 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 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 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 emergency events identified by the risk assessment, 

including the management of the consequences of power failures, natural disasters, and other 
 379

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 emergency; and continuity of operations, including 

delegations of authority and succession plans. 

 (4) Include a process for ensuring cooperation and collaboration with local, tribal, 

regional, State, or Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, including documentation of the hospice’s 

efforts to contact such officials and, when applicable, of its participation 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 section, 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 hospice 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 condition and home environment. 

(3) A system of medical documentation that preserves patient information, protects 

confidentiality of patient information, and ensures records are secure and readily available. 

(4) The use of hospice employees in an emergency and other emergency staffing 

strategies, including the process and role for integration of State and Federally designated health 
 380

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 procedures must address the following: 

 (i) A means to shelter in place for patients, hospice employees who remain in the 

hospice. 

 (ii) Safe evacuation from the hospice, which includes consideration of care and treatment 

needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s). 

and primary and alternate means of communication with external sources of assistance. 

 (iii) The provision of subsistence 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, extinguishing, and alarm systems. 

(C) Sewage and waste disposal. 

 (iv) The role of the hospice 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. 
 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 services under arrangement. 

(iii) Patients’ physicians. 

(iv) Other hospices. 

 (2) Contact information for the following: 

(i) Federal, State, tribal, regional, and local emergency preparedness staff. 

(ii) Other sources of assistance. 

 (3) Primary and alternate means for communicating with the following: 

(i) Hospice’s employees. 

(ii) Federal, State, tribal, 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 care providers to ensure continuity of care. 

 (5) A means, in the event of an evacuation, 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). 

(7) A means of providing information about the hospice’s inpatient occupancy, needs, 

and its ability to provide assistance, to the authority having jurisdiction, the Incident Command 
 382

Center, or designee. 

 (d) Training and testing. The hospice must develop and maintain an emergency 

preparedness training and testing program that must be reviewed and updated at least annually. 

 (1) Training program. The hospice must do all of the following: 

(i) Initial training in emergency preparedness policies and procedures to all new and 

existing hospice employees, and individuals providing services under arrangement, consistent 

with their expected roles. 

(ii) Ensure that hospice employees can demonstrate knowledge of emergency 

procedures. 

(iii) Provide emergency preparedness training at least annually. 

(iv) Periodically review and rehearse its emergency preparedness plan with hospice 

employees (including nonemployee staff), with special emphasis placed on carrying out the 

procedures necessary to protect 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 disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, 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 following the onset of the actual event. 

(iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 
 383

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, 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: REQUIREMENTS 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 preparedness requirements. The PRTF 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 PRTF 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 emergency 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 ensuring cooperation and collaboration with local, tribal, regional, 

State, and Federal emergency preparedness officials’ efforts to ensure an integrated response 

during a disaster or emergency situation, including documentation of the PRTF’s efforts to 

contact such officials and, when applicable, of its participation in collaborative 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 section, 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 energy to maintain the following: 

(A) Temperatures to protect resident health and safety and for the safe and sanitary 

storage of provisions. 

(B) Emergency lighting. 

(C) Fire detection, extinguishing, and alarm systems. 

(D) Sewage and waste disposal. 

 (2) A system to track the location of staff 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; transportation; identification of evacuation location(s); 
 385

and primary and alternate means of communication with external sources of assistance. 

 (4) A means to shelter in place for residents, staff, and volunteers who remain in the 

facility. 

 (5) A system of medical documentation that preserves resident information, protects 

confidentiality of resident information, and ensures records are secure and readily available. 

(6) 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. 

(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 declared by the Secretary, in accordance with 

section 1135 of Act, in the provision 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 services under arrangement. 

(iii) Residents’ physicians. 

(iv) Other PRTFs. 
 386

(v) Volunteers. 

 (2) Contact information for the following: 

(i) Federal, State, tribal, regional, and local emergency preparedness staff. 

(ii) Other sources of assistance. 

 (3) Primary and alternate means for communicating 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 evacuation, 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, the 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 preparedness policies and procedures to all new 

and existing staff, individuals providing services under arrangement, and volunteers, consistent 

with their expected roles. 

(ii) After initial training, provide emergency preparedness training at least annually. 

(iii) Ensure that staff can demonstrate knowledge of emergency procedures. 
 387

(iv) Maintain documentation of all 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 disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at 

least annually. 

(ii) If the PRTF experiences an actual natural 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 following the onset of the actual event. 

(iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, 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 for 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 emergency events identified by the risk assessment. 

 (3) Address participant population, including, but not limited to, the type 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 cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, including documentation of the PACE’s 

efforts to contact such officials 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 the 
 389

communication plan at paragraph (c) of this section. The policies and procedures must address 

management of medical and nonmedical emergencies, including, but not limited to: fire; 

equipment, power, or water failure; care-related 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; staff responsibilities; transportation; 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 their residences at any time due to an emergency 

situation based on the patient’s medical and psychiatric conditions and home environment. 

 (4) A means to shelter in place for participants, staff, and volunteers who remain in the 

facility. 

 (5) A system of medical documentation that preserves participant information, protects 

confidentiality of patient information, and ensures records are secure and readily available. 

 (6) The use of volunteers in an emergency or other emergency staffing strategies, 

including the process and role for integration of State or Federally designated health care 

professionals to address surge needs during an emergency. 

(7) The development of arrangements with other PACE organizations, PACE centers, or 
 390

other providers to receive participants in the event of limitations or cessation of operations to 

ensure the continuity of services to PACE participants. 

(8) The role of the PACE organization 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. 

(9)(i) Emergency equipment, including easily 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 emergency 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; other PACE organizations; and volunteers. 

 (2) Contact information for the following: 

(i) Federal, State, tribal, regional, and local emergency 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, tribal, regional, and local emergency management agencies. 
 391

 (4) A method for sharing information and medical documentation for participants under 

the organization’s care, as necessary, with other health care providers to ensure continuity of 

care. 

 (5) A means, in the event of an evacuation, to release participant 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 care 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 authority 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 program that must be reviewed and updated at least 

annually. 

(1) Training program. The PACE organization must do all of the following: 

(i) Initial training in emergency preparedness policies and procedures to all new and 

existing staff, individuals providing on-site services under arrangement, contractors, participants, 

and volunteers, consistent with their expected roles. 

(ii) Provide emergency preparedness training at least annually. 

 (iii) Ensure that staff demonstrate a knowledge of emergency 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 exercises to test the emergency plan. 

The PACE organization must do the following: 
 392

(i) Participate in a community mock disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, 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 PACE organization is exempt from engaging in a 

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

actual event. 

 (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, 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 participation: 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 requirements of this section, utilizing an all-hazards 

approach. The emergency preparedness program must include, but not be limited to, the 
 393

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 emergency 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 ability to provide in an emergency; and continuity of operations, 

including delegations of authority and succession plans. 

 (4) Include a process for ensuring cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, including documentation of the hospital’s 

efforts to contact such officials and, when applicable, its participation 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 section, 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 energy 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, extinguishing, and alarm systems. 

(D) Sewage and waste disposal. 

 (2) A system to track the location of staff and patients in the hospital’s care both during 

and after the emergency. 

 (3) Safe evacuation from the hospital, which includes consideration of care and treatment 

needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); 

and primary and alternate means of communication with external sources of assistance. 

 (4) A means to shelter in place for patients, staff, and volunteers who remain in the 

facility. 

 (5) A system of medical documentation that preserves patient information, protects 

confidentiality of patient information, and ensures records are secure and readily available. 

(6) The use of volunteers in an emergency and 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. 

(7) The development of arrangements with other 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 provision of care and treatment at an alternate care site identified 
 395

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 services under arrangement. 

(iii) Patients’ physicians. 

(iv) Other hospitals 

(v) Volunteers. 

 (2) Contact information for the following: 

(i) Federal, State, tribal, regional, and local emergency preparedness staff. 

(ii) Other sources of assistance. 

 (3) Primary and alternate means for communicating with the following: 

(i) Hospital’s staff. 

(ii) Federal, State, tribal, 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 evacuation, 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 about the hospital’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 hospital must develop and maintain an emergency 

preparedness training and testing program that must be reviewed and updated at least annually. 

 (1) Training program. The hospital must do all of the following: 

(i) Initial training in emergency preparedness policies and procedures to all new and 

existing staff, individuals providing services under arrangement, and volunteers, consistent with 

their expected role. 

(ii) Provide emergency preparedness training at least annually. 

(iii) Maintain documentation of the training. 

(iv) Ensure that staff can demonstrate knowledge of emergency procedures. 

 (2) Testing. The hospital must conduct drills and exercises to test the emergency plan. 

The hospital must do all of the following: 

(i) Participate in a community mock disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, 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 following the onset of the actual event. 

 (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, or prepared questions designed to challenge 
 397

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 plan set forth in paragraph (a) of this section 

and in the policies and procedures plan set forth in paragraphs (b)(2)(i) and (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 generator 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 available upon request, of generator inspections, 

tests, exercising, operation and repairs. 

 (3) Emergency generator fuel. Hospitals that maintain an onsite fuel source to power 

emergency generators must maintain a quantity of fuel capable of sustaining emergency power 

for the duration of the emergency or until likely resupply. 

17. Add § 482.78 to subpart E to read as follows: 

§ 482.78 Condition of participation: Emergency preparedness for transplant centers. 

 A transplant center must have policies and procedures that address emergency 
 398

preparedness. 

(a) Standard: Agreement with at least one Medicare approved transplant center. A 

transplant center or the hospital in which it operates must have an agreement with at least one 

other Medicare-approved transplant center to provide transplantation services and related care 

for its patients during an emergency. The agreement 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 Procurement Organization (OPO) designated 

by the Secretary. The transplant center must ensure that the written agreement required under 

§ 482.100 addresses the duties and responsibilities 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 Security 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 requirements 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 risk 
 399

assessment, utilizing an all-hazards approach, including missing residents; 

 (2) Include strategies for addressing emergency 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 cooperation and collaboration with local, tribal, 

regional, State, or Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, including documentation of the LTC facility’s 

efforts to contact such officials and, when applicable, of its participation 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 section, 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 and for the safe and sanitary 

storage of provisions; 

(B) Emergency lighting; 

(C) Fire detection, extinguishing, 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 facility, which includes consideration of care and 

treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation 

location(s); and primary and alternate means of communication with external sources of 

assistance. 

 (4) A means to shelter in place for residents, 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 ensures records are secure and readily available. 

(6) The use of volunteers in an emergency or other emergency staffing strategies, 

including the process and role for integration of State or Federally designated health care 

professionals to address surge needs during an emergency. 

(7) The development of arrangements with other LTC facilities and other providers to 

receive residents in the event of limitations or cessation of operations to ensure the continuity of 

services to LTC residents. 

(8) The role of the LTC 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 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 the 
 401

following: 

 (1) Names and contact information for the following: 

(i) Staff. 

(ii) Entities providing services under arrangement. 

(iii) Residents’ physicians. 

(iv) Other LTC facilities. 

(v) Volunteers. 

 (2) Contact information for the following: 

(i) Federal, State, tribal, regional, or local emergency preparedness staff. 

(ii) The State Licensing and Certification Agency. 

(iii) The Office of the State 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, tribal, regional, or local emergency 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 evacuation, 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 authority having jurisdiction or the Incident Command 
 402

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 must be reviewed and updated at least annually. 

(1) Training program. The LTC facility must do all of the following: 

(i) Initial training in emergency preparedness policies and procedures to all new and 

existing staff, individuals providing services under arrangement, and volunteers, consistent with 

their expected roles. 

(ii) Provide emergency preparedness training at least annually. 

(iii) Maintain documentation of the training. 

(iv) Ensure that staff can demonstrate 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 emergency procedures. The LTC facility must 

do the following: 

(i) Participate in a community mock disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, 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 disaster drill for 1 year following the onset of the 

actual event. 

(iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 
 403

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, 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 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 generator 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 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 available upon request, of generator inspections, 

tests, exercising, operation and repairs. 

(3) Emergency generator fuel. LTC facilities that maintain an onsite fuel source to 

power emergency generators must maintain a quantity of fuel capable of sustaining emergency 
 404

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 Individuals with Intellectual Disabilities (ICF/IID) 

must comply with all applicable Federal and State emergency preparedness requirements. The 

ICF/IID 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 ICF/IID must develop and maintain 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, including missing clients. 
 405

 (2) Include strategies for addressing emergency events identified by the risk assessment. 

 (3) Address the special needs of its client population, including, but not limited to, 

persons at-risk; the type of services the ICF/IID 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 cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, including documentation of the ICF/IID 

efforts to contact such officials and, when applicable, of its participation 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 section, 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 energy to maintain the following: 

(A) Temperatures to protect resident health and safety and for the safe and sanitary 

storage of provisions. 

(B) Emergency lighting. 

(C) Fire detection, extinguishing, 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; staff responsibilities; transportation; 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 clients, staff, and volunteers who remain in the 

facility. 

 (5) A system of medical documentation that preserves client information, protects 

confidentiality of client information, and ensures records are secure and readily available. 

 (6) The use of volunteers in an emergency or other emergency staffing strategies, 

including the process and role for integration of State or Federally designated health care 

professionals to address surge needs during an emergency. 

 (7) The development of arrangements with other ICF/IIDs or other providers to receive 

clients in the event of limitations or cessation of operations to ensure the continuity 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 provision of care and treatment 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 communication plan must include the following: 

 (1) Names and contact information for the following: 
 407

 (i) Staff. 

 (ii) Entities providing services under arrangement. 

 (iii) Clients’ physicians. 

 (iv) Other ICF/IIDs. 

 (v) Volunteers. 

 (2) Contact information for the following: 

 (i) Federal, State, tribal, regional, and local emergency 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 communicating with the ICF/IID’s staff, Federal, 

State, tribal, regional, and local emergency management agencies. 

 (4) A method for sharing information and 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 evacuation, 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 about the ICF/IID’s occupancy, needs, and its 

ability to provide assistance, to the authority 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 must 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 emergency preparedness policies and procedures to all new and 

existing staff, individuals providing services under arrangement, and volunteers, consistent with 

their expected roles. 

 (ii) Provide emergency preparedness training at least annually. 

 (iii) Maintain documentation of the training. 

 (iv) Ensure that staff can demonstrate 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 disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, 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-based mock disaster drill for 1 year following the onset of the actual event. 

 (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, 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 participation: 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 requirements 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 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 risk 

assessment, utilizing an all-hazards approach; 

(2) Include strategies for addressing emergency 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 emergency; and continuity of operations, including 

delegations of authority and succession plans. 

(4) Include a process for ensuring cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, including documentation of the HHA’s efforts 
 410

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 section, 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 natural or man-made disaster. 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 psychiatric 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 ensures records are secure and readily available. 

(5) The use of volunteers in an emergency or other emergency staffing strategies, 

including the process and role for integration of State or Federally designated health care 

professionals to address surge needs during an emergency. 

(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 services under arrangement. 

(iii) Patients’ physicians. 

(iv) Other HHAs. 

(v) Volunteers. 

(2) Contact information for the following: 

(i) Federal, State, tribal, regional, or local emergency preparedness staff. 

(ii) Other sources of assistance. 

(3) Primary and alternate means for communicating with the HHA’s staff, Federal, State, 

tribal, regional, and local emergency management agencies. 

(4) A method for sharing information and medical documentation for patients under the 

HHA’s care, as necessary, with other health care providers to ensure continuity of care. 

(5) 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).. 

(6) A means of providing information about the HHA’s needs, and its ability to provide 

assistance, to the authority having jurisdiction, the Incident Command Center, or designee. 

(d) Training and testing. The HHA must develop and maintain an emergency 

preparedness training and testing program that must be reviewed and updated at least annually. 
 412

(1) Training program. The HHA must do all of the following: 

(i) Initial training in emergency preparedness policies and procedures to all new and 

existing staff, individuals providing services under arrangement, and volunteers, consistent with 

their expected roles. 

(ii) Provide emergency preparedness training at least annually. 

(iii) Maintain documentation of the training. 

(ii) Ensure that staff can demonstrate knowledge of emergency procedures. 

(2) Testing. The HHA must conduct drills and exercises to test the emergency plan. The 

HHA must do the following: 

(i) Participate in a community mock disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at 

least annually. 

(ii) If the HHA experiences an actual natural 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 following the onset of the actual event. 

(iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, or prepared questions designed to challenge 

an emergency plan. 

(iv) Analyze the HHA’s response to and maintain documentation of all drills, tabletop 

exercises, and emergency events, and revise the HHA’s emergency plan, as needed.

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS 

25. The authority citation for part 485 continues to read as follows: 
 413

Authority: Secs. 1102 and 1871 of the Social Security 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 participation: Emergency preparedness. 

The Comprehensive Outpatient Rehabilitation Facility (CORF) must comply with all 

applicable Federal and State emergency preparedness requirements. The CORF 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 CORF 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 risk 

assessment, utilizing an all-hazards approach; 

(2) Include strategies for addressing emergency 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 emergency; and continuity of operations, including 

delegations of authority and succession plans. 

(4) Include a process for ensuring cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, including documentation of the CORF’s 
 414

efforts to contact such officials and, when applicable, of its participation in collaborative and 

cooperative planning efforts; 

(5) Be developed and maintained with assistance from fire, safety, 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 section, 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 includes 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 ensures records are secure and readily available. 

(4) The use of volunteers in an emergency and other emergency staffing strategies, 

including the process and role for integration of State or Federally designated health care 

professionals to address surge needs during an emergency. 

(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 services under arrangement. 

(iii) Patients’ physicians. 

(iv) Other CORFs. 

(v) Volunteers. 

(2) Contact information for the following: 

(i) Federal, State, tribal, regional and local emergency preparedness staff. 

(ii) Other sources of assistance. 

(3) Primary and alternate means for communicating with the CORF’s staff, Federal, 

State, tribal, regional, and local emergency management agencies. 

(4) A method for sharing information and medical documentation for patients under the 

CORF’s care, as necessary, with other health care providers to ensure continuity of care. 

(5) A means of providing information about the CORF’s needs, and its ability to provide 

assistance, to the authority having 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 preparedness policies and procedures to all new 

and existing staff, individuals providing services under arrangement, and volunteers, consistent 

with their expected roles. 

(ii) Provide emergency preparedness training at least annually. 

(iii) Maintain documentation of the training. 
 416

(iv) The CORF must ensure that staff can demonstrate knowledge of emergency 

procedures. All new personnel must be oriented and assigned specific responsibilities 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 exercises to test the emergency plan. 

The CORF must do the following: 

(i) Participate in a community mock disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at 

least annually. 

(ii) If the CORF experiences an actual natural or man-made emergency that requires 

activation of the emergency plan, the CORF is exempt from engaging in a community or 

individual, facility-based mock disaster drill for 1 year following the onset of the actual event. 

(iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, or prepared questions designed to challenge 

an emergency plan. 

(iv) Analyze the CORF’s response to and maintain 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 CAH 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 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 risk 

assessment, utilizing an all-hazards approach; 

(2) Include strategies for addressing emergency events identified by the risk assessment; 

(3) Address patient population, including, but not 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 cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, 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 section, 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: 
 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, extinguishing, 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 includes consideration of care and treatment 

needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); 

and primary and alternate means of communication with external sources of assistance. 

(4) A means to shelter in place for patients, staff, and volunteers who remain in the 

facility. 

(5) A system of medical documentation that preserves patient information, protects 

confidentiality of patient information, and ensures records are secure and readily available. 

(6) The use of volunteers in an emergency or other emergency staffing strategies, 

including the process and role for integration of State or Federally designated health care 

professionals to address surge needs during an emergency. 
 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 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 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 services under arrangement. 

(iii) Patients’ physicians. 

(iv) Other CAHs. 

(v) Volunteers. 

(2) Contact information for the following: 

(i) Federal, State, tribal, regional, and local emergency preparedness staff. 

(ii) Other sources of assistance. 

(3) Primary and alternate means for communicating with the following: 

(i) CAH’s staff. 

(ii) Federal, State, tribal, regional, and local emergency management agencies. 
 420

(4) A method for sharing information and medical documentation for patients under the 

CAH’s care, as necessary, with other health care providers to ensure continuity of care. 

(5) A means, in the event of an evacuation, 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). 

(7) A means of providing information about the CAH’s occupancy, needs, and its ability 

to provide assistance, to the authority having jurisdiction or the Incident Command Center, or 

designee. 

(d) Training and testing. The CAH must develop and maintain an emergency 

preparedness training and testing program that must be reviewed and updated at least annually. 

(1) Training program. The CAH must do all of the following: 

(i) Initial training in emergency preparedness policies and procedures, including prompt 

reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, 

personnel, and guests, fire prevention, and cooperation with fire fighting and disaster authorities, 

to all new and existing staff, individuals providing services under arrangement, and volunteers, 

consistent with their expected roles. 

(ii) Provide emergency preparedness training at least annually. 

(iii) Maintain documentation of the training. 

(iv) Ensure that staff can demonstrate 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 disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at 

least annually. 

(ii) If the CAH experiences an actual natural 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 following the onset of the actual event. 

(iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, or prepared questions designed to challenge 

an emergency plan. 

(iv) Analyze the CAH’s response to and maintain documentation of all drills, tabletop 

exercises, and emergency events, and revise 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 generator 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 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 available upon request, of generator inspections, 

tests, exercising, operation, and repairs. 

(3) Emergency generator fuel. Hospitals that maintain an onsite fuel source to power 

emergency generators must maintain a quantity of fuel capable of sustaining emergency power 

for the duration of the emergency or until likely resupply. 

30. Revise § 485.727 to read as follows: 

§ 485.727 Condition of participation: Emergency preparedness. 

The Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of 

Outpatient Physical Therapy and Speech-Language Pathology Services ("Organizations") must 

comply with all applicable Federal and State 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 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 emergency 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 alarm systems and signals; and methods of 

containing fire. 

(5) Include a process for ensuring cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation. 

(6) Be developed and maintained with assistance from fire, safety, 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 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 Organizations, which includes 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 ensures records are secure and readily available. 

(4) 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. 
 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 services under arrangement. 

(iii) Patients’ physicians. 

(iv) Other Organizations. 

(v) Volunteers. 

(2) Contact information for the following: 

(i) Federal, state, tribal, regional and local emergency preparedness staff. 

(ii) Other sources of assistance. 

(3) Primary and alternate means for communicating with the following: 

(i) Organizations’ staff. 

(ii) Federal, state, tribal, regional, and local emergency management agencies. 

(4) A method for sharing information and medical documentation for patients under the 

Organizations’ care, as necessary, with other health care providers to ensure continuity of care. 

(5) A means of providing information about the Organizations’ needs, and their ability to 

provide assistance, to the authority having jurisdiction or the Incident Command Center, or 

designee. 

(d) Training and testing. The Organizations must develop and maintain an emergency 

preparedness training and testing program that must be reviewed and updated at least annually. 
 425

(1) Training program. The Organizations must do all of the following: 

(i) Initial training in emergency preparedness policies and procedures to all new and 

existing staff, individuals providing services under arrangement, and volunteers, consistent with 

their expected roles. 

(ii) Provide emergency preparedness training at least annually. 

(iii) Maintain documentation of the training. 

(iv) The Organizations must ensure that staff can demonstrate 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 disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, 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-based mock disaster drill for 1 year following the onset of the actual event. 

(iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, 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, and 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, 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 emergency events identified by the risk assessment. 

 (3) Address client population, including, but not limited to, the type of services the 

CMHC 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 cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, including documentation of the CMHC’s 

efforts to contact such officials and, when applicable, of its participation 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 section, and the communication plan at 
 427

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 staff 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; transportation; identification of evacuation location(s); 

and primary and alternate means of communication with external sources of assistance. 

 (3) A means to shelter in place for clients, staff, and volunteers who remain in the 

facility. 

 (4) A system of medical documentation that preserves client information, protects 

confidentiality of client information, and ensures records are secure and readily available. 

 (5) The use of volunteers in an emergency or other emergency staffing strategies, 

including the process and role for integration of state or federally designated health care 

professionals to address surge needs during an emergency. 

 (6) The development of arrangements with other CMHCs or other providers to receive 

clients in the event of limitations or cessation of operations to ensure the continuity of services to 

CMHC clients. 

 (7) The role of the CMHC under a waiver declared by the Secretary 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 identified 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 be 
 428

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 services under arrangement. 

(iii) Clients’ physicians. 

(iv) Other CMHCs. 

(v) Volunteers. 

(2) Contact information for the following: 

(i) Federal, State, tribal, regional, and local emergency preparedness staff. 

(ii) Other sources of assistance. 

(3) Primary and alternate means for communicating with the following: 

(i) CMHC’s staff. 

(ii) Federal, State, tribal, regional, and local emergency management agencies. 

 (4) A method for sharing information and medical documentation for clients under the 

CMHC’s care, as necessary, with other health care providers to ensure continuity of care. 

 (5) A means, in the event of an evacuation, 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 about the CMHC’s needs, and its ability to 

provide assistance, to the authority having jurisdiction or the Incident Command Center, or 

designee. 
 429

 (d) Training and testing. The CMHC must develop and maintain an emergency 

preparedness training and testing program that must 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 providing services under 

arrangement, and volunteers, consistent 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 provide emergency preparedness training at least 

annually. 

 (2) Testing. The CMHC must conduct drills and exercises to test the emergency plan. 

The CMHC must: 

 (i) Participate in a community mock disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, 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-based mock disaster drill for 1 year following the onset of the actual event. 

 (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, 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 Service 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) must comply with all applicable Federal 

and State emergency preparedness 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 maintain 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 emergency 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 cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, including documentation of the OPO’s efforts 
 431

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 section, 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 staff during and after an emergency. 

(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. 

(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 services 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, tribal, regional, and local emergency preparedness staff. 
 432

(ii) Other sources of assistance. 

(3) Primary and alternate means for communicating with the following: 

(i) OPO’s staff. 

(ii) Federal, State, tribal, regional, and local emergency management agencies. 

(d) Training and testing. The OPO must develop and maintain an emergency 

preparedness training and testing program that must be reviewed and updated at least annually. 

(1) Training. The OPO must do all of the following: 

(i) Initial training in emergency preparedness policies and procedures to all new and 

existing staff, individuals providing services under arrangement, and volunteers, consistent with 

their expected roles. 

(ii) Provide emergency preparedness training at least annually. 

(iii) Maintain documentation of the training. 

(iv) The OPO must ensure that staff 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 tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, or prepared questions designed to challenge 

an emergency plan.

(ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, 

and emergency events, and revise the 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 procurement 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 within the hospital agreements 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 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 Qualified Health Center (RHC/FQHC) must comply 

with all applicable Federal and State emergency preparedness requirements. The RHC/FQHC 

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 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 emergency 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 emergency; and continuity of operations, including 

delegations of authority and succession plans. 

(4) Include a process for ensuring cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, including documentation of the RHC/FQHC’s 

efforts to contact such officials and, when applicable, of its participation 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 section, 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 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 ensures records are secure and readily available. 
 435

(4) 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. 

(c) Communication plan. The RHC/FQHC 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 services under arrangement. 

(iii) Patients’ physicians. 

(iv) Other RHCs/FQHCs. 

(v) Volunteers. 

(2) Contact information for the following: 

(i) Federal, State, tribal, regional, and local emergency preparedness staff. 

(ii) Other sources of assistance. 

(3) Primary and alternate means for communicating with the following: 

(i) RHC/FQHC’s staff. 

(ii) Federal, State, tribal, regional, and local emergency management agencies. 

(4) 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). 
 436

(5) A means of providing information about the RHC/FQHC’s needs, and its ability to 

provide assistance, to the authority having jurisdiction or the Incident Command Center, or 

designee. 

(d) Training and testing. The RHC/FQHC must develop and maintain an emergency 

preparedness training and testing program that must be reviewed and updated at least annually. 

(1) Training program. The RHC/FQHC must do all of the following: 

(i) Initial training in emergency preparedness policies and procedures to all new and 

existing staff, individuals providing services under arrangement, and volunteers, consistent with 

their expected roles, 

(ii) Provide emergency preparedness training at least annually. 

(iii) Maintain documentation of the training. 

(iv) Ensure that staff can demonstrate knowledge of emergency procedures. 

(2) Testing. The RHC/FQHC must conduct exercises to test the emergency plan. The 

RHC/FQHC must do the following: 

(i) Participate in a community mock disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at 

least annually. 

(ii) If the RHC/FQHC experiences an actual natural or man-made emergency that 

requires activation of the emergency plan, the RHC/FQHC is exempt from engaging in a 

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

actual event. 

(iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 
 437

and a set of problem statements, directed messages, 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 Security 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 participation: Emergency preparedness. 

The dialysis facility must comply with all applicable Federal and State emergency 

preparedness requirements. These emergencies include, 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 geographic 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 and 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 emergency 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 cooperation and collaboration with local, tribal, 

regional, State, and Federal emergency preparedness officials’ efforts to ensure an integrated 

response during a disaster or emergency situation, 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 agency is aware of the 

dialysis facility’s needs in the event of an emergency. 

(b) Policies and procedures. The dialysis 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 section, and the 

communication plan at paragraph (c) of this section. The policies and procedures must be 

reviewed and updated at least annually. These emergencies include, 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 geographic area. At a minimum, the policies and 

procedures must address the following: 

(1) A system to track the location of staff and patients in the dialysis facility’s care both 

during and after the emergency. 
 439

(2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and 

needs of the patients. 

(3) A means to shelter in place for patients, staff, and volunteers who remain in the 

facility. 

(4) A system of medical documentation that preserves patient information, protects 

confidentiality of patient information, and ensures records are secure and readily available. 

(5) The use of volunteers in an emergency or other emergency staffing strategies, 

including the process and role for integration of State or Federally designated health care 

professionals to address surge needs during an emergency. 

(6) The development of arrangements with other dialysis facilities or other providers to 

receive patients in the event of limitations or cessation 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 emergency management officials. 

(8) A process to ensure that emergency medical system assistance can be obtained when 

needed. 

(9) A process ensuring that emergency equipment, 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 be 
 440

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 services under arrangement. 

(iii) Patients’ physicians. 

(iv) Other dialysis facilities. 

(v) Volunteers. 

(2) Contact information for the following: 

(i) Federal, State, tribal, regional or local emergency preparedness staff. 

(ii) Other sources of assistance. 

(3) Primary and alternate means for communicating with the following: 

(i) Dialysis facility’s staff. 

(ii) Federal, State, tribal, regional, or local emergency management agencies. 

(4) A method for sharing information and medical documentation for patients under the 

dialysis facility’s care, as necessary, with other health care providers to ensure continuity of care. 

(5) A means, in the event of an evacuation, 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). 

(7) A means of providing information about the dialysis facility’s needs, and its ability to 

provide assistance, to the authority having jurisdiction or the Incident Command Center, or 

designee. 
 441

(d) Training, testing, and orientation. The dialysis facility must develop and maintain an 

emergency preparedness training, testing and patient orientation program 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 emergency preparedness policies and procedures to all new and 

existing staff, individuals providing services under arrangement, and volunteers, consistent with 

their expected roles. 

(ii) Provide emergency preparedness training at least annually. Staff training must: 

(A) Ensure that staff can demonstrate knowledge 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 include 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 the 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 staff 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 drills and exercises to test the emergency 

plan. The dialysis facility must: 

(i) Participate in a community mock disaster drill at least annually. If a community 

mock disaster drill is not available, conduct an individual, 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 dialysis facility is exempt from engaging in a 

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

actual event. 

(iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a 

group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, 

and a set of problem statements, directed messages, or prepared questions designed to challenge 

an emergency plan. 

(iv) Analyze the dialysis facility’s response to and maintain documentation of all drills, 

tabletop exercises, and emergency events, and revise the dialysis facility’s emergency plan, as 

needed. 

(3) Patient orientation. Emergency preparedness patient training. The facility must 

provide appropriate orientation and training to patients, including the areas specified in 

paragraph (d)(1) of this section. 
CMS-3178-P 

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; No. 

93.773, Medicare—Hospital Insurance; and Program 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-P
 444

NOTE: The following appendix will not appear in the Code of Federal Regulations 

APPENDIX--Emergency Preparedness Resource Documents and Sites

Presidential Directives: 

• Homeland Security Presidential Directive (HSPD-5): “Management of Domestic 

Incidents” authorized the Department of Homeland Security to develop and administer the 

National Incident Management System (NIMS). NIMS consists of federal, state, local, tribal 

governments, private-sector and nongovernmental organizations to work together to prevent, 

respond to and recover from domestic incidents. 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 Influenza and Implementation Plan is a 

comprehensive approach to addressing the threat of pandemic influenza and can be found at 

http://www.flu.gov/professional/federal/pandemic-influenza.pdf

• The World Health Organization (WHO) maintains a relatively up-to-date human case 

count of reported cases and death related to pandemic influenzas. The document can be found at 

http://www.who.int/csr/disease/avian_influenza/country/en/index.html

• The National Strategy for Pandemic Influenza Implementation Plan was established to 

ensure that the Federal government’s efforts and 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 personnel 
 445

and insurance of continuity of operations. This document can be found at 

http://www.fao.org/docs/eims/upload/221561/national_plan_ai_usa_en.pdf

• Homeland Security Presidential Directive (HSPD-21) addresses public health and 

medical preparedness. It establishes a National Strategy for Public Health and Medical 

Preparedness. The key principles are: preparedness for all potential catastrophic health events, 

vertical and horizontal coordination across levels of government, regional approach to health 

preparedness, engagement of the private sector, academia and other non-governmental entities, 

and the roles of individual families and communities. It discusses integrated biosurveillance 

capability, countermeasure stockpiling and rapid distribution of medical countermeasures, mass 

casualty care in coordinating existing resources, and community resilience 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 Guidelines” adopt an all-hazards and risk-based approach to 

preparedness. It provides a set of national planning scenarios that represent a range of threats 

that warrant national attention. For further information, this document can be found at 

http://www.dhs.gov/xlibrary/assets/National_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 national 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-policy-directive-8-nationalpreparedness and at http://www.phe.gov/Preparedness/legal/policies/Pages/ppd8.aspx
 446

Office of Inspector General (OIG), Government Accountability Office (GAO) and 

additional reports and their recommendations: 

• OIG study entitled, “Nursing Home Emergency Preparedness and Responses During 

Recent Hurricanes” (OEI-06-06-00020) conducted in response 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 two recommendations for CMS: (1) strengthen 

federal certification standards for nursing home emergency plans; and (2) encourage 

communication and collaboration between State and local emergency entities and nursing homes. 

As a result of the OIG’s recommendations, the Secretary initiated an emergency preparedness 

improvement effort 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 entitled, “Tropical Cyclone Report, Hurricane 

Katrina, 23-30 August 2005” provided data on the 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, “Disaster Preparedness: Preliminary Observations on the 

Evacuation of Hospitals and Nursing Homes Due to Hurricanes” (GAO-06-443R) discusses the 

GAO’s findings regarding (1) responsibility for the decision to evacuate hospitals and nursing 

homes; (2) issues administrators consider when deciding to evacuate hospitals and nursing 

homes; and (3) the federal response capabilities that support evacuation of hospitals and nursing 

homes. This can be found at http://www.gao.gov/new.items/d06443r.pdf

• GAO report entitled, “Disaster Preparedness: Limitations in Federal Evacuation 

Assistance for Health Facilities Should be Addressed” (GAO-06-826) supports the findings 
 447

noted in the first GAO report. In addition, the GAO noted that the evacuation issues that 

facilities faced during and after the hurricanes occurred due to their inability to secure 

transportation when needed. This report can be found at www.gao.gov/cgi-bin/getrpt?GAO-06-

826.

• GAO report, an after-event analysis, entitled, “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 that 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 hospitals in any major metropolitan area. This 

report can be found at http://www.gao.gov/docdblite/details.php?rptno=GAO-06-1003

• GAO report, an after-event analysis entitled, “Disaster Recovery: Past Experiences 

Offer Recovery Lessons for Hurricane Ike and Gustav and Future Disasters” (GAO-09-437T) 

concluded that recovery from major 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 During Disasters: 2007-2010, OEI-06-09-00270. The report noted 6 

areas of concern that nursing homes did not include in their plans but could affect residents 

during an emergency which are: staffing, resident care, resident identification, information and 

tracking, sheltering in place, evacuation and communication and collaboration. 

GAO Recommendations for Response to Influenza Pandemics: 
 448

• GAO report entitled, “Influenza Pandemic: 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 presence 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 responsible federal agencies in implementing the plans 342 action 

items set forth in the “National Strategy for Pandemic Influenza: Implementation Plan. These 

reports can be found at http://www.gao.gov/new.items/d1073.pdf and http://georgewbushwhitehouse.archives.gov/homeland/pandemic-influenza-implementation.htm. 

Resources for Healthcare Providers and Suppliers 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 information 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 facilities, home health agencies, other health care providers and 

clinicians. 

• “HHS Pandemic Influenza Plan Supplement 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 Pandemic Influenza: A Primer for Governors and 

Senior State Officials (2006) written by the National Governors Association (NGA) provides 
 449

both current and historical perspective on potential 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 prescribe, administer, or dispense 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/legal/prepact/pages/default.aspx

Public Health Emergency Preparedness: 

• HRSA Policy Information notice entitled, “Health Center 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 national level by an authorized public official 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 disasters. To access this list, go 

to http://emergency.cdc.gov/disasters/ under “emergency preparedness and response” and click 

on “specific hazards”. 

• RAND Corporation 2006 report stated that since 2001, the challenge has been the need 

to define public health emergency preparedness and the key elements that characterize a wellprepared community. This report can be found at 

http://www.rand.org/publications/randreview/issues/summer2006/pubhealth.html

The RAND Corporation convened a diverse panel of experts to propose a public health 

emergency preparedness definition. According to this expert panel, in an article by Nelson, 

Lurie, Wasserman and Zakowski, titled “Conceptualizing and Defining Public Health 

Emergency Preparedness”, published in the American Journal of Public Health, Supplement 1, 
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2007, Volume 97, No S9-S11 defined public health emergency preparedness as the capability of 

the public health and health care systems, communities, and individuals to prevent, protect 

against, quickly respond to and recover from health emergencies. This report can be found at 

http://ajph.aphapublications.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.healthyamericans.org/report/101/. 

• The HHS, 2011 Hospital Preparedness Program (HPP) report, entitled "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 capabilities, 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 passage 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/pahpa/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 Response to Urgent Case Reports," evaluated the 

ability of local public health agencies (LPHAs) to adequately meet "a preparedness standard" set 
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by the CDC. The standard was for the LPHAs to receive and respond to urgent case reports of 

communicable diseases 24 hours a day, 7 days a week. The goal of the test was to contact an 

"action officer" (that is, physician, nurse, epidemiologist, bioterrorism coordinator, or infection 

control practitioner) responsible for responding to urgent case reports. 

• A June 2004 article published by Lurie, N., Wasserman, J., Stoto, M., Myers, S., 

Namkung, P., Fielding, J., and Valdez, R. B., entitled, "Local Variations in Public Health 

Preparedness: Lessons from California", provides information on performance measures that 

were developed based on identified essential public 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 (distributed nationally in 

FY 2012), “Healthcare Preparedness Capabilities: 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/responders/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 system 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/Documents/capabilities.pdf. 
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• Center for Health Policy, Columbia University School of Nursing, policy paper, 

March 2008 entitled, "Adapting Standards of Care Under Extreme Conditions: Guidance for 

Professionals During Disasters, Pandemics, and Other Extreme Emergencies". This paper, 

aimed at the nursing population, discusses the challenges to meeting the usual standards of care 

during natural or man-made disasters and makes recommendations for effectively providing care 

during emergency events. The paper can be found at: 

http://www.nursingworld.org/MainMenuCategories/HealthcareandPolicyIssues/DPR/TheLawEth

icsofDisasterResponse/AdaptingStandardsofCare.aspx. 

• Institute of Medicine (IOM) September 2009 report to the HHS entitled, "Guidelines 

for Establishing Crisis Standards of Care for Use in Disaster Situations. The report provides 

guidance for State and local health agencies and health care facilities regarding the standards of 

care that should apply during disaster situations. This report covers guidance on conserving, 

substituting, adapting, and doing without resources. Further information on this report can be 

found at http://www.nap.edu/catalog.php?record_id=12749#. 

• CMS published two guidance documents dated September 30, 2007 and 

October 24, 2007. The first document entitled, "Provider Survey and Certification Frequently 

Asked Questions: Declared Public Health Emergencies – 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/SurveyCertEmergPrep/Downloads/AllHazardsFAQs.pdf. The second 

document entitled, “Survey and Certification Emergency Preparedness Initiative: Provider 

Survey & Certification Declared Public Health Emergency FAQs – All Hazards," provides web 

address for emergency preparedness information. It provides links to various resources and to 
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other federal emergency preparedness websites and can be found at: 

(http://www.nhha.org/WhatsNewFiles/S&C-08-01.01.AllHazardsFAQsmemo.pdf). In addition, 

the website entitled, "Emergency Preparedness 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 information on emergency planning for people with 

disabilities and on how important it is to include people with disabilities 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 Emergency Planning (2005) 

[FR Doc. 2013-30724 Filed 12/20/2013 at 4:15 pm; Publication Date: 12/27/2013]