Vol. 78 Friday, 

No. 249 December 27, 2013 

Part II 

Department of Health and Human Services 

Centers for Medicare & Medicaid Services 

42 CFR Parts 403, 416, 418, et al. 

Medicare and Medicaid Programs; Emergency Preparedness Requirements 

for Medicare and Medicaid Participating Providers and Suppliers; Proposed 

Rule 


sroberts on DSK5SPTVN1PROD with PROPOSALS
79082 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 403, 416, 418, 441, 460, 

482, 483, 484, 485, 486, 491, and 494 

[CMS–3178–P] 

RIN 0938–AO91 

Medicare and Medicaid Programs; 

Emergency Preparedness 

Requirements for Medicare and 

Medicaid Participating Providers and 

Suppliers 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

establish national emergency 

preparedness requirements for 

Medicare- and Medicaid-participating 

providers and suppliers to ensure that 

they adequately plan for both natural 

and man-made disasters, and coordinate 

with federal, state, tribal, regional, and 

local emergency preparedness systems. 

It would also ensure that these 

providers and suppliers are adequately 

prepared to meet the needs of patients, 

residents, clients, and participants 

during disasters and emergency 

situations. 

We are proposing emergency 

preparedness requirements that 17 

provider and supplier types must meet 

to participate in the Medicare and 

Medicaid programs. Since existing 

Medicare and Medicaid requirements 

vary across the types of providers and 

suppliers, we are also proposing 

variations in these requirements. These 

variations are based on existing 

statutory and regulatory policies and 

differing needs of each provider or 

supplier type and the individuals to 

whom they provide health care services. 

Despite these variations, our proposed 

regulations would provide generally 

consistent emergency preparedness 

requirements, enhance patient safety 

during emergencies for persons served 

by Medicare- and Medicaidparticipating facilities, and establish a 

more coordinated and defined response 

to natural and man-made disasters. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on February 25, 2014. 

ADDRESSES: In commenting, please refer 

to file code CMS–3178–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3178–P, P.O. Box 8013, Baltimore, 

MD 21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Mail Stop C4–26–05, 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses prior to the close of 

the comment period: a. For delivery in 

Washington, DC—Centers for Medicare 

& Medicaid Services, Department of 

Health and Human Services, Room 445– 

G, Hubert H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

7195 in advance to schedule your 

arrival with one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Janice Graham, (410) 786–8020. 

Mary Collins, (410) 786–3189. 

Diane Corning, (410) 786–8486. 

Ronisha Davis, (410) 786–6882. 

Lisa Parker, (410) 786–4665. 

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

Acronyms 

AAAHC Accreditation Association for 

Ambulatory Health Care, Inc. 

AAAASF American Association for 

Accreditation for Ambulatory Surgery 

Facilities, Inc. 

AAR/IP After Action Report/Improvement 

Plan 

ACHC Accreditation Commission for 

Health Care, Inc. 

ACHE American College of Healthcare 

Executives 

AHA American Hospital Association 

AO Accrediting Organization 

AOA American Osteopathic Association 

ASC Ambulatory Surgical Center 

ARCAH Accreditation Requirements for 

Critical Access Hospitals 

ASPR Assistant Secretary for Preparedness 

and Response 

BLS Bureau of Labor Statistics 

BTCDP Bioterrorism Training and 

Curriculum Development Program 

CAH Critical Access Hospital 

CAMCAH Comprehensive Accreditation 

Manual for Critical Access Hospitals 

CAMH Comprehensive Accreditation 

Manual for Hospitals 

CASPER Certification and the Survey 

Provider Enhanced Reporting 

CDC Centers for Disease Control and 

Prevention 

CFC Conditions for Coverage 

CHAP Community Health Accreditation 

Program 

CMHC Community Mental Health Center 

COI Collection of Information 

COP Conditions of Participation 

CORF Comprehensive Outpatient 

Rehabilitation Facilities 

CPHP Centers for Public Health 

Preparedness 

CRI Cities Readiness Initiative 


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DHS Department of Homeland Security 

DHHS Department of Health and Human 

Services 

DOL Department of Labor 

DPU Distinct Part Units 

DSA Donation Service Area 

EOP Emergency Operations Plans 

EC Environment of Care 

EMP Emergency Management Plan 

EP Emergency Preparedness 

ESF Emergency Support Function 

ESRD End-Stage Renal Disease 

FEMA Federal Emergency Management 

Agency 

FDA Food and Drug Administration 

FQHC Federally Qualified Health Clinic 

GAO Government Accountability Office 

HFAP Healthcare Facilities Accreditation 

Program 

HHA Home Health Agencies 

HPP Hospital Preparedness Program 

HRSA Health Resources and Services 

Administration 

HSC Homeland Security Council 

HSEEP Homeland Security Exercise and 

Evaluation Program 

HSPD Homeland Security Presidential 

Directive 

HVA Hazard Vulnerability Analysis 

ICFs/IID Intermediate Care Facilities for 

Individuals with Intellectual Disabilities 

ICR Information Collection Requirements 

IDG Interdisciplinary Group 

IOM Institute of Medicine 

JCAHO Joint Commission on the 

Accreditation of Healthcare Organizations 

JPATS Joint Patient Assessment and 

Tracking System 

LD Leadership 

LPHA Local Public Health Agencies 

LSC Life Safety Code 

LTC Long Term Care 

MMRS Metropolitan Medical Response 

System 

MS Medical Staff 

NDMS National Disaster Medical System 

NF Nursing Facilities 

NFPA National Fire Protection Association 

NIMS National Incident Management 

System 

NIOSH National Institute for Occupational 

Safety and Health 

NLTN National Laboratory Training 

Network 

NRP National Response Plan 

NRF National Response Framework 

NSS National Security Staff 

OBRA Omnibus Budget Reconciliation Act 

OIG Office of the Inspector General 

OPHPR Office of Public Health 

Preparedness and Response 

OPO Organ Procurement Organization 

OPT Outpatient Physical Therapy 

OPTN Organ Procurement and 

Transplantation Network 

OSHA Occupational Safety and Health 

Administration 

ORHP Office of Rural Health Policy 

PACE Program for the All-Inclusive Care for 

the Elderly 

PAHPA Pandemic and All-Hazards 

Preparedness Act 

PHEP Public Health Emergency 

Preparedness 

PIN Policy Information Notice 

PPD Presidential Policy Directive 

PRTF Psychiatric Residential Treatment 

Facilities 

QAPI Quality Assessment and Performance 

Improvement 

QIES Quality Improvement and Evaluation 

System 

RFA Regulatory Flexibility Act 

RNHCI Religious Nonmedical Health Care 

Institutions 

RHC Rural Health Clinic 

SAMHSA Substance Abuse and Mental 

Health Services Administration 

SLP Speech Language Pathology 

SNF Skilled Nursing Facility 

SNS Strategic National Stockpile 

TEFRA Tax Equity and Fiscal 

Responsibility Act 

TFAH Trust for America’s Health 

TJC The Joint Commission 

TTX Tabletop Exercise 

UMRA Unfunded Mandates Reform Act 

UPMC University of Pittsburgh Medical 

Center 

WHO World Health Organization 

Table of Contents 

I. Overview 

A. Executive Summary 

1. Purpose 

2. Summary of the Major Provisions 

B. Current State of Emergency 

Preparedness 

1. Federal Emergency Preparedness 

2. State and Local Emergency Preparedness 

3. Hospital Preparedness 

4. GAO and OIG Reports 

C. Statutory and Regulatory Background 

II. Provisions of the Proposed Regulation 

A. Emergency Preparedness Regulations for 

Hospitals (§ 482.15) 

1. Emergency Plan 

a. Emergency Planning Resources 

b. Risk Assessment 

c. Patient Population and Available 

Services 

d. Succession Planning and Cooperative 

Efforts 

2. Policies and Procedures 

3. Communication Plan 

4. Training and Testing 

B. Emergency Preparedness Regulations for 

Religious Nonmedical Health Care 

Institutions (RNHCIs) (§ 403.748) 

C. Emergency Preparedness Regulations for 

Ambulatory Surgical Centers (ASCs) 

(§ 416.54) 

D. Emergency Preparedness Regulations for 

Hospice (§ 418.113) 

E. Emergency Preparedness Regulations for 

Inpatient Psychiatric Residential 

Treatment Facilities (PRTFs) (§ 441.184) 

F. Emergency Preparedness Regulations for 

Programs of All-Inclusive Care for the 

Elderly (PACE) (§ 460.84) 

G. Emergency Preparedness Regulations for 

Transplant Centers (§ 482.78) 

H. Emergency Preparedness Regulations for 

Long-Term Care (LTC) Facilities 

(§ 483.73) 

I. Emergency Preparedness Regulations for 

Intermediate Care Facilities for 

Individuals with Intellectual Disabilities 

(ICF/IID) (§ 483.475) 

J. Emergency Preparedness Regulations for 

Home Health Agencies (HHAs) (§ 484.22) 

K. Emergency Preparedness Regulations for 

Comprehensive Outpatient 

Rehabilitation Facilities (CORFs) 

(§ 485.68) 

L. Emergency Preparedness Regulations for 

Critical Access Hospitals (CAHs) 

(§ 485.625) 

M. Emergency Preparedness Regulations 

for Clinics, Rehabilitation Agencies, and 

Public Health Agencies as Providers of 

Outpatient Physical Therapy and 

Speech-Language Pathology Services 

(§ 485.727) 

N. Emergency Preparedness Regulations for 

Community Mental Health Centers 

(CMHCs) (§ 485.920) 

O. Emergency Preparedness Regulations for 

Organ Procurement Organizations 

(OPOs) (§ 486.360) 

P. Emergency Preparedness Regulations for 

Rural Health Clinics (RHCs) and 

Federally Qualified Health Centers 

(FQHCs) (§ 491.12) 

Q. Emergency Preparedness Regulations for 

End-Stage Renal Disease (ESRD) 

Facilities (§ 494.62) 

III. Collection of Information 

A. Factors Influencing ICR Burden 

Estimates 

B. Sources of Data Used in Estimates of 

Burden Hours and Cost Estimates 

C. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 403.748) 

D. ICRs Regarding Condition for Coverage: 

Emergency Preparedness (§ 416.54) 

E. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 418.113) 

F. ICRs Regarding Emergency Preparedness 

(§ 441.184) 

G. ICRs Regarding Emergency Preparedness 

(§ 460.84) 

H. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 482.15) 

I. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

for Transplant Centers (§ 482.78) 

J. ICRs Regarding Emergency Preparedness 

(§ 483.73) 

K. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 483.475) 

L. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 484.22) 

M. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 485.68) 

N. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 485.625) 

O. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 485.727) 

P. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 485.920) 

Q. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 486.360) 

R. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 491.12) 

S. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 494.62) 


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T. Summary of Information Collection 

Burden 

IV. Regulatory Impact Analysis (RIA) 

A. Statement of Need 

B. Overall Impact 

C. Anticipated Effects on Providers and 

Suppliers: General Provisions 

D. Condition of Participation: Emergency 

Preparedness for Religious Nonmedical 

Health Care Institutions (RNHCIs) 

E. Condition for Coverage: Emergency 

Preparedness for Ambulatory Surgical 

Centers (ASCs)—Testing (§ 416.54(d)(2)) 

F. Condition of Participation: Emergency 

Preparedness for Hospices—Testing 

(§ 418.113(d)(2)) 

G. Emergency Preparedness for Psychiatric 

Residential Treatment Facilities (PRTFs) 

Training and Testing (§ 441.184(d)) 

H. Emergency Preparedness for Program for 

the All-Inclusive Care for the Elderly 

(PACE) Organizations—Training and 

Testing (§ 460.84(d)) 

I. Condition of Participation: Emergency 

Preparedness for Hospitals 

J. Condition of Participation: Emergency 

Preparedness for Transplant Centers 

K. Emergency Preparedness for Long Term 

Care (LTC) Facilities 

L. Condition of Participation: Emergency 

Preparedness for Intermediate Care 

Facilities for Individuals With 

Intellectual Disabilities (ICFs/IID) 

M. Condition of Participation: Emergency 

Preparedness for Home Health Agencies 

(HHAs) 

N. Conditions of Participation: 

Comprehensive Outpatient 

Rehabilitation Facilities (CORFs)— 

(§ 485.68(d)(2)(i) through (iii)) 

O. Condition of Participation: Emergency 

Preparedness for Critical Access 

Hospitals (CAHs)—Testing 

(§ 485.625(d)(2)) 

P. Condition of Participation: Emergency 

Preparedness for Clinics, Rehabilitation 

Agencies, and Public Health Agencies as 

Providers of Outpatient Physical 

Therapy and Speech-Language Pathology 

(‘‘Organizations’’)—Testing 

(§ 485.727(d)(2)(i) Through (iii)) 

Q. Condition of Participation: Emergency 

Preparedness for Community Mental 

Health Centers (CMHCs)—Training and 

Testing (§ 485.920(d)) 

R. Conditions of Participation: Emergency 

Preparedness for Organ Procurement 

Organizations (OPOs)—Training and 

Testing (§ 486.360(d)(2)(i) Through (iii)) 

S. Emergency Preparedness: Conditions for 

Certification for Rural Health Clinics 

(RHCs) and Conditions for Coverage for 

Federally Qualified Health Clinics 

(FQHCs) 

T. Condition of Participation: Emergency 

Preparedness for End-Stage Renal 

Disease Facilities (Dialysis Facilities)— 

Testing (§ 494.62(d)(2)(i) through (iv)) 

U. Summary of the Total Costs 

V. Benefits of the Proposed Rule 

W. Alternatives Considered 

X. Accounting Statement 

Appendix—Emergency Preparedness 

Resource Documents and Sites 

I. Overview 

A. Executive Summary 

1. Purpose 

Over the past several years, the 

United States has been challenged by 

several natural and man-made disasters. 

As a result of the September 11, 2001 

terrorist attacks, the subsequent anthrax 

attacks, the catastrophic hurricanes in 

the Gulf Coast states in 2005, flooding 

in the Midwestern states in 2008, 

tornadoes and floods in the spring of 

2011, the 2009 H1N1 influenza 

pandemic, and Hurricane Sandy in 

2012, readiness for public health 

emergencies has been put on the 

national agenda. For the purpose of this 

proposed regulation, ‘‘emergency’’ or 

‘‘disaster’’ can be defined as an event 

affecting the overall target population or 

the community at large that precipitates 

the declaration of a state of emergency 

at a local, state, regional, or national 

level by an authorized public official 

such as a governor, the Secretary of the 

Department of Health and Human 

Services (HHS), or the President of the 

United States. (See Health Resources 

and Services Administration (HRSA) 

Policy Information notice entitled, 

‘‘Health Center Emergency Management 

Program Expectations,’’ (Document No. 

2007–15, dated August 22, 2007, found 

at http://www.hsdl.org/

?view&did=478559). Disasters can 

disrupt the environment of health care 

and change the demand for health care 

services. This makes it essential that 

health care providers and suppliers 

ensure that emergency management is 

integrated into their daily functions and 

values. 

In preparing this proposed rule, we 

reviewed the guidance, developed by 

the Food and Drug Administration 

(FDA), the Centers for Disease Control 

and Prevention (CDC), the Health 

Resources and Services Administration 

(HRSA), and the Office of the Assistant 

Secretary for Preparedness and 

Response (ASPR). Additionally, we held 

regular meetings with these agencies 

and ASPR to collaborate on federal 

emergency preparedness requirements. 

To guide us in the development of this 

rule, we also reviewed several other 

sources to find the most current best 

practices in the health care industry. 

These sources included other federal 

agencies; The Joint Commission (TJC) 

standards for emergency preparedness; 

the American Osteopathic Association 

(AOA) standards for disaster 

preparedness (currently written for 

Critical Access Hospitals (CAHs) only); 

the National Fire Protection Association 

(NFPA) standards in NFPA 101 Life 

Safety Code and NFPA 1600: ‘‘Standard 

on Disaster/Emergency Management 

and Business Continuity Programs,’’ 

2007 Edition; state-level requirements 

for some states, including those for 

California and Maryland; and policy 

guidance from the American College of 

Healthcare Executives (ACHE), entitled 

the ‘‘Healthcare Executives’ Role in 

Emergency Preparedness,’’ which 

reinforces our position regarding the 

necessity of this proposed rule. Many of 

the resources we reviewed in the 

development of this proposed rule are 

listed in the APPENDIX—‘‘Emergency 

Preparedness Resource Documents and 

Sites.’’ We encourage providers and 

suppliers to use these resources to 

develop and maintain their emergency 

preparedness plans. 

We also reviewed existing Medicare 

emergency preparedness requirements 

for both providers and suppliers. We 

concluded that current emergency 

preparedness regulatory requirements 

are not comprehensive enough to 

address the complexities of actual 

emergencies. Specifically, the 

requirements do not address the need 

for: (1) Communication to coordinate 

with other systems of care within local 

jurisdictions (for example. cities, 

counties) or states; (2) contingency 

planning; and (3) training of personnel. 

Based on our analysis of the written 

reports, articles, and studies, as well as 

on our ongoing dialogue with 

representatives from the federal, state, 

and local levels and with various 

stakeholders, we believe that, currently, 

in the event of a disaster, health care 

providers and suppliers across the 

nation would not have the necessary 

emergency planning and preparation in 

place to adequately protect the health 

and safety of their patients. Underlying 

this problem is the pressing need for a 

more consistent regulatory approach 

that would ensure that providers and 

suppliers nationwide are required to 

plan for and respond to emergencies 

and disasters that directly impact 

patients, residents, clients, participants, 

and their communities. As we have 

learned from past events and disasters, 

the current regulatory patchwork of 

federal, state, and local laws and 

guidelines, combined with the various 

accrediting organization emergency 

preparedness standards, falls far short of 

what is needed to require that health 

care providers and suppliers be 

adequately prepared for a disaster. 

Thus, we are proposing these emergency 

preparedness requirements to establish 

a comprehensive, consistent, flexible, 

and dynamic regulatory approach to 

emergency preparedness and response 

that incorporates the lessons learned 


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from the past, combined with the 

proven best practices of the present. We 

recognize that central to this approach 

is to develop and guide emergency 

preparedness and response within the 

framework of our national health care 

system. To this end, these proposed 

regulations would also encourage 

providers and suppliers to coordinate 

their preparedness efforts within their 

own communities and states as well as 

across state lines, as necessary to 

achieve their goals. We are soliciting 

comments on whether certain 

requirements should be implemented on 

a staggered basis. 

2. Summary of the Major Provisions 

We are proposing emergency 

preparedness requirements that will be 

consistent and enforceable for all 

affected Medicare and Medicaid 

providers and suppliers. This proposed 

rule addresses the three key essentials 

needed to ensure that health care is 

available during emergencies: 

safeguarding human resources, ensuring 

business continuity, and protecting 

physical resources. Current regulations 

for Medicare and Medicaid providers 

and suppliers do not adequately address 

these key elements. 

Based on our research and 

consultation with stakeholders, we have 

identified four core elements that are 

central to an effective and 

comprehensive framework of emergency 

preparedness requirements for the 

various Medicare and Medicaid 

participating providers and suppliers. 

The four elements of the emergency 

preparedness program are as follows: 

• Risk assessment and planning: This 

proposed rule would propose that prior 

to establishing an emergency plan, a risk 

assessment would be performed based 

on utilizing an ‘‘all-hazards’’ approach. 

An all-hazards approach is an integrated 

approach to emergency preparedness 

planning that focuses on capacities and 

capabilities that are critical to 

preparedness for a full spectrum of 

emergencies or disasters. This approach 

is specific to the location of the provider 

and supplier considering the particular 

types of hazards which may most likely 

occur in their area. 

• Policies and procedures: We are 

proposing that facilities be required to 

develop and implement policies and 

procedures based on the emergency 

plan and risk assessment. 

• Communication plan: This 

proposed rule would require a facility to 

develop and maintain an emergency 

preparedness communication plan that 

complies with both federal and state 

law. Patient care must be wellcoordinated 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 wellorganized, effective training program 

must include providing initial training 

in emergency preparedness policies and 

procedures. We propose that the facility 

ensure that staff can demonstrate 

knowledge of emergency procedures 

and provide this training at least 

annually. We would require that 

facilities conduct drills and exercises to 

test the emergency plan. 

We are seeking public comments on 

when these CoPs should be 

implemented. 

B. Current State of Emergency 

Preparedness 

1. Federal Emergency Preparedness 

In response to the September 11, 2001 

terrorist attacks and the subsequent 

national need to refine the nation’s 

strategy to handle emergency situations, 

there have been numerous efforts across 

federal agencies to establish a 

foundation for development and 

expansion of emergency preparedness 

systems. The following is a brief 

overview of some emergency 

preparedness activities at the federal 

level. Additional information is 

included in the appendix to this 

proposed rule. 

a. Presidential Directives 

Three Presidential Directives HSPD– 

5, HSPD–21 and PPD–8, require 

agencies to coordinate their emergency 

preparedness activities with each other 

and across federal, state, local, tribal, 

and territorial governments. Although 

these directives do not specifically 

require Medicare providers and 

suppliers to adopt such measures, they 

have set the stage for what we expect 

from our providers and suppliers in 

regard to their roles in a more unified 

emergency preparedness system. The 

Homeland Security Presidential 

Directive (HSPD–5), ‘‘Management of 

Domestic Incidents,’’ was issued on 

February 28, 2003. This directive 

authorizes the Department of Homeland 

Security to develop and administer the 

National Incident Management System 

(NIMS). The NIMS provides a consistent 

national template that enables federal, 

state, local, and tribal governments, as 

well as private-sector and 

nongovernmental organizations, to work 

together effectively and efficiently to 

prepare for, prevent, respond to, and 

recover from domestic incidents, 

regardless of cause, size, or complexity, 

including acts of catastrophic terrorism. 

The Presidential Policy Directive (PPD– 

8 focuses on strengthening the security 

and resilience of the nation through 

systematic preparation for the full range 

of 21st century hazards that threaten the 

security of the nation, including acts of 

terrorism, cyber attacks, pandemics, and 

catastrophic natural disasters. The 

directive is founded by 3 key principles 

which include: (1) employ an all-ofnation/whole community approach, 

integrate efforts across federal, state, 

local, tribal and territorial governments; 

(2) build key capabilities to confront any 

challenge; and (3) utilize an assessment 

system focused on outcomes to measure 

and track progress. Finally, the 

Presidential directive published on 

October 18, 2007, entitled, ‘‘Homeland 

Security Presidential Directive/HSPD– 

21,’’ addresses public health and 

medical preparedness. The directive, 

found at http://www.dhs.gov/xabout/

laws/gc_1219263961449.shtm, 

establishes a National Strategy for 

Public Health and Medical Preparedness 

(Strategy), which aims to transform our 

national approach to protecting the 

health of the American people against 

all disasters. HSPD–21 summarizes 

implementation actions that are the four 

most critical components of public 

health and medical preparedness: 

biosurveillance, countermeasure 

stockpiling and distribution, mass 

casualty care, and community 

resilience. The directive states that these 

components will receive the highest 

priority in public health and medical 

preparedness efforts. 

b. Assistant Secretary for Preparedness 

and Response 

In December 2006, the President 

signed the Pandemic and All-Hazards 

Preparedness Act (PAHPA) (Pub. L. 

109–417). The purpose of the Pandemic 

and All-Hazards Preparedness Act is ‘‘to 

improve the Nation’s public health and 

medical preparedness and response 

capabilities for emergencies, whether 

deliberate, accidental, or natural.’’ The 

Office of the Assistant Secretary for 

Preparedness and Response (ASPR) was 

created under the PAHPA Act in the 

wake of Katrina to lead the nation in 

preventing, preparing for, and 

responding to the adverse health effects 

of public health emergencies and 

disasters. The Secretary of HHS 

delegates to ASPR the leadership role 

for all health and medical services 

support functions in a health emergency 

or public health event. ASPR also serves 

as the senior advisor to the HHS 


sroberts on DSK5SPTVN1PROD with PROPOSALS
79086 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

Secretary on public health and medical 

preparedness and provides, at a 

minimum, support for; building federal 

emergency medical operational 

response and recovery capabilities; 

countermeasures research, advance 

development, and procurement; and 

grants to strengthen the capabilities of 

healthcare preparedness at the state, 

regional, local and healthcare coalition 

levels for public health emergencies and 

medical disasters. The office provides 

federal support, including medical 

professionals through ASPR’s National 

Disaster Medical System (NDMS), to 

augment state and local capabilities 

during an emergency or disaster. The 

purpose of the NDMS is to establish a 

single, integrated, and national medical 

response capability to assist state and 

local authorities in dealing with the 

medical impacts of major peacetime 

disasters and to provide support to the 

military and the Department of Veterans 

Affairs medical systems in caring for 

casualties evacuated back to the U.S. 

from overseas conflicts. The NDMS, as 

part of the HHS, led by ASPR, supports 

federal agencies in the management and 

coordination of the federal medical 

response to major emergencies and 

federally declared disasters including 

natural disasters, technological 

disasters, major transportation 

accidents, and acts of terrorism, 

including weapons of mass destruction 

events. Additional information can be 

found at: http://www.phe.gov/

preparedness/responders/ndms/Pages/

default.aspx. 

ASPR also administers the Hospital 

Preparedness Program (HPP), which 

provides leadership and funding 

through grants and cooperative 

agreements to states, territories, and 

eligible municipalities to improve surge 

capacity and enhance community and 

hospital preparedness for public health 

emergencies. Through the work of its 

state partners, HPP has advanced the 

preparedness of hospitals and 

communities in numerous ways, 

including building healthcare 

coalitions, planning for all hazards, 

increasing surge capacity, tracking the 

availability of beds and other resources 

using electronic systems, and 

developing communication systems that 

are interoperable with other response 

partners. 

The first response in a disaster is 

always local, and comprised of local 

government emergency services 

supplemented by state and volunteer 

organizations. This aspect of the 

‘‘disaster response’’ is specifically 

coordinated by state and local 

authorities. When an incident 

overwhelms or is anticipated to 

overwhelm state resources, the 

Governor of a state or chief executive of 

a tribe may request federal assistance. In 

such cases, the affected local 

jurisdiction, tribe, state, and the federal 

government will collaborate to provide 

that necessary assistance. When it is 

clear that state capabilities will be 

exceeded, the Governor or the tribal 

executive can request federal assistance, 

including assistance under the Robert 

Stafford Disaster Relief and Emergency 

Assistance Act (Stafford Act). The 

Stafford Act authorizes the President to 

provide financial and other assistance to 

state and local governments, certain 

private nonprofit organizations, and 

individuals to support response, 

recovery, and mitigation efforts 

following Presidential emergency or 

major disaster declarations. 

The National Response Framework 

(NRF), a guide to how the nation should 

conduct all hazards responses, includes 

15 Emergency Support Functions 

(ESFs), which are groupings of 

governmental and certain private sector 

capabilities into an organizational 

structure. The purpose of the ESFs is to 

provide support, resources, program 

implementation, and services that are 

most likely needed to save lives, protect 

property and the environment, restore 

essential services and critical 

infrastructure, and help victims and 

communities return to normal following 

domestic incidents. HHS is the primary 

agency responsible for ESF 8—Public 

Health and Medical Services. 

The Secretary of HHS leads all federal 

public health and medical response to 

public health and medical emergencies 

and incidents that are covered by the 

Stafford Act, via NRF, or the Public 

Health Service Act. Under the NRF, ESF 

8 is coordinated by the Secretary of HHS 

principally through the Assistant 

Secretary for Preparedness and 

Response (ASPR). ESF 8—Public Health 

and Medical Services provides the 

mechanism for coordinated federal 

assistance to supplement state, tribal, 

and local jurisdictional resources in 

response to a public health and medical 

disaster, potential or actual incidents 

requiring a coordinated federal 

response, or during a developing 

potential health and medical 

emergency. 

c. Centers for Disease Control and 

Prevention 

The Centers for Disease Control and 

Prevention (CDC) Office of Public 

Health Preparedness and Response 

(OPHPR) leads the agency’s 

preparedness and response activities by 

providing strategic direction, support, 

and coordination for activities across 

CDC as well as with local, state, tribal, 

national, territorial, and international 

public health partners. CDC provides 

funding and technical assistance to 

states to build and strengthen public 

health capabilities. Ensuring that states 

can adequately respond to threats will 

result in greater health security; a 

critical component of overall U.S. 

national security. Additional 

information can be found at: http:// 

www.cdc.gov/phpr/. The CDC Public 

Health Emergency Preparedness (PHEP) 

cooperative agreement, led by OPHPR, 

is a critical source of funding for state, 

local, tribal, and territorial public health 

departments. Since 2002, the PHEP 

cooperative agreement has provided 

nearly $9 billion to public health 

departments across the nation to 

upgrade their ability to effectively 

respond to a range of public health 

threats, including infectious diseases, 

natural disasters, and biological, 

chemical, nuclear, and radiological 

events. Preparedness activities funded 

by the PHEP cooperative agreement are 

targeted specifically for the 

development of emergency-ready public 

health departments that are flexible and 

adaptable. The Strategic National 

Stockpile (SNS), administered by the 

CDC, is a stockpile of pharmaceuticals 

and medical supplies. The SNS program 

was created to assist states and local 

communities in responding to public 

health emergencies, including those 

resulting from terrorist attacks and 

natural disasters. The SNS program 

ensures the availability of necessary 

medicines, antidotes, medical supplies, 

and medical equipment for states and 

local communities, to counter the effects 

of biological pathogens and chemical 

and nerve agents. (http://www.cdc.gov/

phpr/stockpile/stockpile.htm). 

The Cities Readiness Initiative (CRI), 

led by CDC, is a federally funded pilot 

program to help cities increase their 

capacity to deliver medicines and 

medical supplies within 48 hours after 

recognition of a large-scale public health 

emergency such as a bioterrorism attack 

or a nuclear accident. More information 

on this effort can be found at: http:// 

www.bt.cdc.gov/cri/. An evaluative 

report of this program since its 

inception, requested by the CDC, 

performed by the RAND Corporation, 

and published in 2009, entitled, ‘‘Initial 

Evaluation of the Cities Readiness 

Initiative’’ can be found at http:// 

www.rand.org/pubs/technical_reports/

2009/RAND_TR640.pdf. 

Given the heightened concern 

regarding the impact of various 

influenza outbreaks in recent years, the 

federal government has created a Web 

site with ‘‘one-step access to U.S. 


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Government H1N1, Avian, and 

Pandemic Flu Information’’ at 

www.flu.gov. The Web site provides 

links to influenza guidance and 

information from federal agencies, such 

as the CDC, as well as checklists for 

pandemic preparedness. The 

information and links are found at 

http://www.flu.gov/professional/

index.html. This Web site includes 

information for hospitals, long term care 

facilities, outpatient facilities, home 

health agencies, other health care 

providers, and clinicians. For example, 

the ‘‘Hospital Pandemic Influenza 

Planning Checklist’’ provides guidance 

on structure for planning and decision 

making; development of a written 

pandemic influenza plan; and elements 

of an influenza pandemic plan. The 

checklist is comprehensive and lists 

everything a hospital should do to 

prepare for a pandemic, from planning 

for coordination with local and regional 

planning and response groups to 

infection control. 

2. State and Local Preparedness 

A review of studies and articles 

regarding readiness of state and local 

jurisdictions reveals that there is 

inconsistency in the level of emergency 

preparedness amongst states and need 

for improvement in certain areas. In a 

report by the Trust for America’s Health 

(TFAH) (December 2012, http:// 

www.healthyamericans.org/report/101/) 

entitled, ‘‘Ready or Not? Protecting the 

Public’s Health from Diseases, Disasters, 

and Bioterrorism’’ the authors assessed 

state-by-state public health 

preparedness nearly 10 years after the 

September 11th and anthrax tragedies. 

Using 10 key indicators to rate levels of 

public health preparedness, some key 

findings included: (1) 29 states cut 

public health funding from fiscal years 

(FY) 2010 through 2012, with 2 of these 

states cutting funds for a second year in 

a row and 14 for 3 consecutive years, 

and that federal funds for state and local 

preparedness have decreased by 38 

percent from FY 2005 through 2012 and 

(2) 35 states and Washington DC do not 

currently have complete climate change 

adaption plans, which include planning 

for health threats posed by extreme 

weather events. 

An article entitled, ‘‘Public Health 

Response to Urgent Case Reports,’’ 

published in Health Affairs (August 30, 

2005), Dausey, D., Lurie, N., and 

Diamond, A.) evaluated the ability of 

local public health agencies (LPHAs) to 

adequately meet ‘‘a preparedness 

standard’’ set by the CDC. The standard 

was for the LPHAs ‘‘to receive and 

respond to urgent case reports of 

communicable diseases 24 hours a day, 

7 days a week.’’ Using 18 metropolitan 

area LPHAs that were roughly evenly 

distributed by agency size, structure, 

and region of the country, the goal of the 

test was to contact an ‘‘action officer’’ 

(that is, physician, nurse, 

epidemiologist, bioterrorism 

coordinator, or infection control 

practitioner) responsible for responding 

to urgent case reports. 

During a 4-month period of time, each 

LPHA was contacted several times and 

asked questions regarding triage 

procedures, what questions would be 

asked in the event of an urgent case 

being filed, next steps taken after 

receiving such a report, and who would 

be contacted. Although the LPHAs had 

a substantial role in community public 

health through prevention and 

treatment efforts, the authors found 

significant variation in performance and 

the systems in place to respond to such 

reports. 

We also reviewed an article published 

in June 2004 by Lurie, N., Wasserman, 

J., Stoto, M., Myers, S., Namkung, P., 

Fielding, J., and Valdez, R. B., entitled, 

‘‘Local Variations in Public Health 

Preparedness: Lessons from California’’ 

found at http:// 

content.healthaffairs.org/cgi/content/

full/hlthaff.w4.341/DC1. The authors 

stated that ‘‘evidence-based measures to 

assess public health preparedness are 

lacking in California.’’ Using an ‘‘expertpanel process,’’ the researchers 

developed performance measures based 

on ten identified essential public health 

services. They performed site visits and 

tabletop exercises to evaluate 

preparedness across the state in 

geographic locations identified as urban, 

rural, and border status to detect and 

respond to a hypothetical smallpox 

outbreak based on the different 

measures of preparedness. Overall, the 

researchers found that there was a lack 

of consensus regarding what 

‘‘emergency preparedness’’ 

encompassed and a wide variation in 

what various governmental agencies 

deemed to be adequate emergency 

preparedness ‘‘readiness’’ in California. 

They noted that gaps in the 

infrastructure were common. 

Throughout the jurisdictions 

investigated, there were similarities 

noted in the shortage of nurses, the 

number of essential workers nearing 

retirement age, and the lack of 

epidemiologists, lab personnel, and 

public health nurses to meet potential 

needs. Such gaps in personnel 

infrastructure were found in many 

jurisdictions. In some jurisdictions, 

there was incomplete information 

regarding the demographics of persons 

who could be considered potentially 

vulnerable or part of an underserved 

population. 

In one situation, there was also great 

variability in the length of time it took 

to bring three suspicious cases to public 

health officers’ attention and for these 

officers to realize that these cases were 

related. There was great variation in the 

public health officers’ ability to rapidly 

alert the physician and hospital 

community of an outbreak. There was a 

lack of consensus regarding when to 

report a potential outbreak to the public. 

There also was wide variation in 

knowledge of public health legal 

authority, specifically, in regard to 

quarantine and its enforcement. We 

believe these findings to be typical of 

most states. 

3. Hospital Preparedness 

Hospitals are the focal points for 

health care in their respective 

communities; thus, it is essential that 

hospitals have the capacity to respond 

in a timely and appropriate manner in 

the event of a natural or man-made 

disaster. Additionally, since Medicareparticipating hospitals are required to 

evaluate and stabilize every patient seen 

in the emergency department and to 

evaluate every inpatient at discharge to 

determine his or her needs and to 

arrange for post-discharge care as 

needed, hospitals are in the best 

position to coordinate emergency 

preparedness planning with other 

providers and suppliers in their 

communities. We would expect 

hospitals to be prepared to provide care 

to the greatest number of disaster 

victims for which they have the 

capacity, while meeting at least minimal 

obligations for care to all who are in 

need. 

In 2007, ASPR contracted with the 

Center for Biosecurity of the University 

of Pittsburgh Medical Center (UPMC) 

(the Center) to conduct an assessment of 

U.S. hospital preparedness and to 

develop recommendations for 

evaluating and improving future 

hospital preparedness efforts. The 

Center’s assessment, entitled ‘‘Hospitals 

Rising to the Challenge: The First Five 

Years of the U.S. Hospital Preparedness 

Program and Priorities Going Forward’’ 

describes the most important 

components of preparedness for mass 

casualty response at the local and 

regional hospital and healthcare system 

levels. This evaluation report was based 

on extensive analyses of the published 

literature, government reports, and HPP 

program assessments, as well as on 

detailed conversations with 133 health 

officials and hospital professionals 

representing every state, the largest 

cities, and major territories of the U.S. 


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The authors stated that major 

disasters can severely challenge the 

ability of healthcare systems to 

adequately care for large numbers of 

patients (surge capacity) or victims with 

unusual or highly specialized medical 

needs (surge capability) such as 

occurred with Hurricane Katrina. The 

authors further stated that addressing 

medical surge and medical system 

resilience requires implementing 

systems that can effectively manage 

medical and health responses, as well as 

developing and maintaining 

preparedness programs. There were 

numerous findings and conclusions in 

the 2007 report. The researchers found 

that since the start of the HPP in 2002, 

individual hospitals’ disaster 

preparedness has improved 

significantly. The report found that 

hospital senior leadership is actively 

supporting and participating in 

preparedness activities, and disaster 

coordinators within hospitals have 

given sustained attention to 

preparedness and response planning 

efforts. Hospital emergency operations 

plans (EOPs) have become more 

comprehensive and, in many locations, 

are coordinated with community 

emergency plans and local hazards. 

Disaster training has become more 

rigorous and standardized; hospitals 

have stockpiled emergency supplies and 

medicines; situational awareness and 

communications are improving; and 

exercises are more frequent and of 

higher quality. The researchers also 

found improved collaboration and 

networking among and between 

hospitals, public health departments, 

and emergency management and 

response agencies. These coalitions are 

believed to represent the beginning of a 

coordinated community-wide approach 

to medical disaster response. 

However, ASPR Healthcare 

Preparedness Capabilities: National 

Guidance for Healthcare System 

Preparedness (2012) and CDC Public 

Health Preparedness Capabilities: 

National Standards for State and Local 

Planning (March 2011) notes numerous 

federal directives that recognize the 

need for a consistent approach to 

preparedness planning across the nation 

so as to ensure an effective response. 

The 2010 IOM report also notes that 

direction at the federal level is essential 

in order to ensure a coordinated, 

interoperable disaster response. (IOM 

Medical Surge Capacity. 2009 Forum on 

Medical and Public Health Preparedness 

for Catastrophic Events, 2010)’’ 

4. OIG and GAO Reports 

Since Katrina, several studies 

regarding the preparedness of health 

care providers have been published. In 

general, these reports and studies point 

to a need for improved requirements to 

ensure that providers and suppliers are 

adequately prepared to meet the needs 

of patients, residents, clients, and 

participants during disasters and 

emergency situations. 

In response to a request from the U.S. 

Senate Special Committee on Aging 

calling for an examination of nursing 

home emergency preparedness, the 

Office of the Inspector General (OIG) 

conducted a study during 2004 through 

2005 entitled, ‘‘Nursing Home 

Emergency Preparedness and Responses 

During Recent Hurricanes,’’ (OEI–06– 

06–00020) http://oig.hhs.gov/oei/

reports/oei-06-06-00020.pdf). The OIG 

reviewed state survey data for 

emergency preparedness measures both 

for the nation in general and for the Gulf 

States (Alabama, Florida, Louisiana, 

Mississippi, and Texas). The study 

indicated that in 2004 through 2005, 94 

percent of nursing homes nationwide 

met the limited federal regulations for 

emergency plans then in existence, 

while only 80 percent met the federal 

standards for emergency training. 

Similar compliance rates were noted in 

the Gulf states. However, the OIG found 

that nursing homes in the Gulf states 

experienced problems even though they 

were in compliance with federal 

interpretive guidelines. Further, they 

experienced problems whether they 

evacuated residents or sheltered them in 

place. The OIG listed the problems 

encountered by Gulf state nursing 

homes including, transportation 

contracts that were not honored; lengthy 

travel times for residents; insufficient 

food and water for residents and staff; 

complicated resident medication needs; 

host facilities that were unavailable or 

that were inadequately prepared, 

provisioned, or staffed for the transfer of 

residents; and difficulty re-entering 

their own facilities. As further detailed 

in the OIG report, the main reasons for 

these problems were lack of effective 

planning; failure to properly execute 

emergency plans; failure to anticipate 

the specific problems encountered; and 

failure to adjust decisions and actions to 

specific situations. 

The OIG also found that some facility 

administrators deviated, many 

significantly, from their emergency 

plans or worked beyond the plans, 

either because the plans were not 

updated or plans did not include 

instructions for certain circumstances. 

The report goes on to note that many of 

the nursing home emergency 

preparedness plans did not consider the 

following factors: the need to evacuate 

residents to alternate sites as evidenced 

by a formal agreement with a host 

facility; criteria to determine whether to 

evacuate residents or shelter them in 

place; a means by which an individual 

resident’s care needs would be 

identified and met; and re-entry into the 

facility following an evacuation. 

Although some local communities 

were directly involved in the evacuation 

of their nursing home residents, other 

nursing homes received assistance with 

evacuation from resident and staff 

family members, parent corporations, 

and ‘‘sister facilities,’’ according to the 

OIG report. A few nursing homes 

reported that problems with state and 

local government coordination during 

the hurricanes contributed to the 

problems they encountered. 

Based on this study, the OIG had two 

recommendations for CMS: (1) 

Strengthen federal certification 

standards for nursing home emergency 

plans by including requirements for 

specific elements of emergency 

planning; and (2) encourage 

communication and collaboration 

between state and local emergency 

entities and nursing homes. As a result 

of the OIG’s recommendations, the 

Secretary initiated an emergency 

preparedness improvement effort to be 

coordinated across all HHS agencies. 

Our development of this proposed rule 

is an important part of HHS-wide efforts 

to meet the Department’s overall 

emergency preparedness goals and 

objectives by directly addressing the 

OIG recommendations. In April 2012, 

the OIG issued a subsequent report 

entitled, ‘‘Gaps Continue to Exist in 

Nursing Home Emergency Preparedness 

and response During Disasters: 2007– 

2010,’’ (OEI–06–09–00270 http://

oig.hhs.gov/oei/reports/oei-06-09- 

00270.pdf). This report notes that many 

of the gaps in nursing home 

preparedness and response identified in 

the 2006 report still exist. 

We also reviewed several Government 

Accountability Office (GAO) reports on 

emergency preparedness. One such 

report is entitled, ‘‘Disaster 

Preparedness: Preliminary Observations 

on the Evacuation of Hospitals and 

Nursing Homes Due to Hurricanes’’ 

(GAO–06–443R), was published on 

February 16, 2006, and can be found at 

http://www.gao.gov/new.items/

d06443r.pdf). This report discusses the 

GAO’s findings regarding—(1) 

Responsibility for the decision to 

evacuate hospitals and nursing homes; 

(2) the issues administrators consider 

when deciding to evacuate hospitals 

and nursing homes; and (3) the federal 

response capabilities that support 

evacuation of hospitals and nursing 

homes. 


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The GAO found that ‘‘hospital and 

nursing home administrators are often 

responsible for deciding whether to 

evacuate patients from their facilities 

due to disasters, including hurricanes or 

other natural disasters. State and local 

governments can order evacuations of 

the population or segments of the 

population during emergencies, but 

health care facilities may be exempt 

from these orders.’’ The GAO found that 

hospitals and nursing home 

administrators evacuate only as a last 

resort and that these facilities’ 

emergency plans are designed primarily 

to shelter in place. The GAO also found 

that administrators considered the 

availability of adequate resources to 

shelter in place, the risks to patients in 

deciding when to evacuate, the 

availability of transportation to move 

patients, the availability of receiving 

facilities to accept patients, and the 

destruction of the facility’s or 

community’s infrastructure. 

The GAO noted that nursing home 

administrators also must consider the 

fact that nursing home residents cannot 

care for themselves and generally have 

no home and no place to live other than 

the nursing home. Therefore, in the 

event of an evacuation, nursing homes 

also need to consider the necessity of 

locating facilities that can accommodate 

their residents for a long period of time. 

A second report from the GAO about 

the hurricanes’ impact entitled, 

‘‘Disaster Preparedness: Limitations in 

Federal Evacuation Assistance for 

Health Facilities Should be Addressed,’’ 

(GAO–06–826) July, 2006, 

www.gao.gov/cgi-bin/getrpt?GAO–06– 

826), supports the findings noted in the 

first GAO report on the disasters. In 

addition, the GAO noted that the 

evacuation issues that facilities faced 

during and after the hurricanes occurred 

due to their inability to secure 

transportation when needed. Despite 

previously established contracts with 

transportation companies, demand for 

this assistance overwhelmed the supply 

of vehicles in the community. 

A third report, an after-event analysis 

entitled, ‘‘Hurricane Katrina: Status of 

Hospital Inpatient and Emergency 

Departments in the Greater New Orleans 

Area,’’ (GAO–06–1003) September 29, 

2006, http://www.gao.gov/docdblite/

details.php?rptno=GAO-06-1003) 

revealed that, as of April 2006: (1) 

Emergency departments were 

experiencing overcrowding; but that (2) 

the number of staffed inpatient beds per 

1,000 population was greater than that 

of the national average and expected to 

increase further. However, the study 

found that the number of staffed 

inpatient beds was not available in 

psychiatric care settings. In fact, some 

persons with mental health needs had to 

be transferred out of the area due to a 

lack of beds. Attracting and retaining 

nursing and support staff were two 

problems that were identified as 

hindering efforts to maintain an 

adequate supply of staffed beds for 

psychiatric patients. 

While this study focused specifically 

on patient care issues in the New 

Orleans area, the same issues are 

common to hospitals in any major 

metropolitan area. Given the 

vulnerability of persons with mental 

illness and the tremendous stress a manmade or natural disaster can put on the 

entire general population, an increase in 

the number of persons who seek mental 

health services and require inpatient 

psychiatric care can be expected 

following any natural or man-made 

disaster. 

In another report from the GAO, an 

after-event analysis entitled, ‘‘Disaster 

Recovery: Past Experiences Offer 

Recovery Lessons for Hurricane Ike and 

Gustav and Future Disasters,’’ (GAO– 

09–437T March 3, 2009, http://

www.gao.gov/products/GAO-09-437T) 

the GAO concluded that recovery from 

major disasters is a complex 

undertaking that involves the combined 

efforts of federal, state, and local 

government in order to succeed. The 

GAO stated that while the federal 

government provides a significant 

amount of financial and technical 

assistance for recovery, state and local 

jurisdictions should work closely with 

federal agencies to secure and make use 

of those resources. 

In a report from the GAO, entitled, 

‘‘Influenza Pandemic: Gaps in Pandemic 

Planning and Preparedness Need to be 

Addressed,’’ (GAO–09–909T July 29, 

2009; http://www.gao.gov/new.items/

d09909t.pdf), the GAO expressed its 

concern that, despite a number of 

actions having been taken to plan for a 

pandemic, including developing a 

National Strategy and Implementation 

Plan, many gaps in pandemic planning 

and preparedness still existed in the 

presence of a potential pandemic 

influenza outbreak. 

In November 2009, the GAO 

published an additional report entitled, 

‘‘Influenza Pandemic: Monitoring and 

Assessing the Status of the National 

Pandemic Implementation Plan Needs 

Improvement,’’ (GAO–10–73) (http://

www.gao.gov/new.items/d1073.pdf). In 

this report, the GAO assessed the 

progress of the responsible federal 

agencies (including HHS) in 

implementing the action items set forth 

in the ‘‘National Strategy for Pandemic 

Influenza: Implementation Plan’’ (the 

Plan) (http://georgewbushwhitehouse.archives.gov/homeland/

pandemic-influenzaimplementation.html). Specifically, the 

researchers were interested in 

determining how the Homeland 

Security Council (HSC) and the 

responsible federal agencies were 

monitoring the progress and completion 

of the Plan’s 342 action items, and 

assessing the extent to which selected 

action items were completed, whether 

activity had continued on the selected 

action items reported as complete, and 

the nature of that work. Having 

conducted an in-depth analysis of a 

random sample of 60 action items, the 

GAO found the status of selected action 

items considered complete was difficult 

to determine. Specifically, the GAO 

found that: (1) Measures of performance 

used to determine status did not always 

fully reflect the descriptions of the 

action items; (2) some selected action 

items were designated as complete 

despite requiring actions outside the 

authority of the responsible entities; and 

(3) additional work was conducted on 

some selected action items designated 

as complete. Ultimately, the GAO 

recommended that, in order to improve 

how progress is monitored and 

completion is assessed under the Plan 

and subsequent updates of the Plan, the 

HSC should instruct the White House 

National Security Staff (NSS) to work 

with responsible federal agencies to: (1) 

Develop a monitoring and reporting 

process for action items that are 

intended for nonfederal entities, such as 

state and local governments; (2) identify 

the types of information needed to 

decide whether to carry out the 

response-related action items; and (3) 

develop measures of performance that 

are more consistent with the 

descriptions of the action items. 

C. Statutory and Regulatory Background 

Various sections of the Social Security 

Act (the Act) define the terms Medicare 

uses for each provider and supplier type 

and list the requirements that each 

provider and supplier must meet to be 

eligible for Medicare and Medicaid 

participation. Each statutory provision 

also specifies that the Secretary may 

establish other requirements as the 

Secretary finds necessary in the interest 

of the health and safety of patients, 

although the exact wording of such 

authority may differ slightly between 

different provider and supplier types. 

These requirements are called the 

Conditions of Participation (CoPs) for 

providers and the Conditions for 

Coverage (CfCs) for suppliers. The CoPs 

and CfCs are intended to protect public 

health and safety and ensure that high 


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quality care is provided to all persons. 

Further, the Public Health Service (PHS) 

Act sets forth additional requirements 

that certain Medicare providers and 

suppliers must meet to participate. 

The following are the statutory and 

regulatory citations for the providers 

and suppliers for which we intend to 

propose emergency preparedness 

regulations: 

• Religious Nonmedical Health Care 

Institutions (RNHCIs)—section 1821 of 

the Act and 42 CFR 403.700 through 

403.756. 

• Ambulatory Surgical Centers 

(ASCs)—section 1832(a)(2)(F)(i) of the 

Act and 42 CFR 416.40 through 416.49. 

• Hospices—section 1861(dd)(1) of 

the Act and 42 CFR 418.52 through 

418.116. 

• Inpatient Psychiatric Services for 

Individuals Under Age 21 in Psychiatric 

Facilities or Programs (PRTFs)—sections 

1905(a) and 1905(h) of the Act and 42 

CFR 441.150 through 441.182 and 42 

CFR 483.350 through 483.376. 

• Programs of All-Inclusive Care for 

the Elderly (PACE)—sections 1894, 

1905(a), and 1934 of the Act and 42 CFR 

460.2 through 460.210. 

• Hospitals—section 1861(e)(9) of the 

Act and 42 CFR 482.1 through 482.66. 

• Transplant Centers—sections 

1861(e)(9) and 1881(b)(1) of the Act and 

42 CFR 482.68 through 482.104. 

• Long Term Care (LTC) Facilities 

–Skilled Nursing Facilities (SNFs) 

–under section 1819 of the Act, Nursing 

Facilities (NFs)—under section 1919 of 

the Act, and 42 CFR 483.1 through 

483.180. 

• Intermediate Care Facilities for 

Individuals with Intellectual Disabilities 

(ICF/IID)—section 1905(d) of the Act 

and 42 CFR 483.400 through 483.480. 

• Home Health Agencies (HHAs)— 

sections 1861(o), 1891 of the Act and 42 

CFR 484.1 through 484.55. 

• Comprehensive Outpatient 

Rehabilitation Facilities (CORFs)— 

section 1861(cc)(2) of the Act and 42 

CFR 485.50 through 485.74. 

• Critical Access Hospitals (CAHs)— 

sections 1820 and 1861(mm) of the Act 

and 42 CFR 485.601 through 485.647. 

• Clinics, Rehabilitation Agencies, 

and Public Health Agencies as Providers 

of Outpatient Physical Therapy and 

Speech-Language Pathology Services— 

section 1861(p) of the Act and 42 CFR 

485.701 through 485.729. 

• Community Mental Health Centers 

(CMHCs)—section 1861(ff)(3)(B)(i)(ii) of 

the Act, section 1913(c)(1) of the PHS 

Act, and 42 CFR 410.110. 

• Organ Procurement Organizations 

(OPOs)—section 1138 of the Act and 

section 371 of the PHS Act and 42 CFR 

486.301 through 486.348. 

• Rural Health Clinics (RHCs)— 

section 1861(aa) of the Act and 42 CFR 

491.1 through 491.11; Federally 

Qualified Health Centers (FQHCs)— 

section 1861(aa) of the Act and 42 CFR 

491.1 through 491.11, except 491.3. 

• End-Stage Renal Disease (ESRD) 

Facilities—sections 1881(b), 1881(c), 

1881(f)(7) of the Act and 42 CFR 494.1 

through 494.180. 

We considered proposing these 

regulations for each provider and 

supplier type individually, as we 

updated their CoPs or CfCs over time. 

However, for the reasons we have 

already discussed, we believe the most 

prudent course of action is to publish 

emergency preparedness requirements 

for Medicare and Medicaid providers 

and suppliers in a single proposed rule. 

Thus, we are proposing regulatory 

language for 17 Medicare and Medicaid 

providers and suppliers to address the 

four main aspects of emergency 

preparedness: (1) Risk assessment and 

planning; (2) policies and procedures; 

(3) communication; and (4) training. 

II. Provisions of the Proposed 

Regulations 

This proposed rule responds to 

concerns from the Congress, the health 

care community, and the public 

regarding the ability of health care 

providers and suppliers to plan and 

execute appropriate emergency response 

procedures for disasters. We developed 

this proposed rule taking into 

consideration the extent of regulatory 

oversight that is currently in existence. 

We are proposing requirements for 

facilities to ensure the continued 

provision of necessary care at the 

facility or, if needed, the evacuation and 

transfer of patients to a location that can 

supply necessary care. Regulations that 

address these functions too specifically 

may become outdated over time as 

technology and the nature of threats 

change. However, as our analysis of 

existing regulations, and the OIG and 

GAO reports discussed in section I. of 

this proposed rule, indicate regulations 

that are too broad may be ineffective. 

Our challenge is to develop core 

components that can be used across 

provider and supplier types as diverse 

as hospitals, organ procurement 

organizations, and home health 

agencies, while tailoring requirements 

for individual provider and supplier 

types to their specific needs and 

circumstances, as well as the needs of 

their patients, residents, clients, and 

participants. 

We have identified four core elements 

that we believe are central to an 

effective emergency preparedness 

system and must be addressed to offer 

a more comprehensive framework of 

emergency preparedness requirements 

for the various Medicare- and Medicaidparticipating providers and suppliers. 

The four elements are—(1) risk 

assessment and planning; (2) policies 

and procedures; (3) communication; and 

(4) training and testing. We have also 

proposed an additional requirement for 

OPOs entitled ‘‘Agreements with other 

OPOs and hospitals.’’ 

We believe many of the proposed 

elements of an emergency preparedness 

plan need to be conducted at the level 

of an individual facility. However, other 

elements may be addressed as 

effectively, and more efficiently, at a 

broader organizational level, for 

example, a system for preserving 

medical documentation. Our regulatory 

requirements for each provider and 

supplier type are based on the 

comprehensive emergency preparedness 

requirements that we are proposing for 

hospitals. Since we are aware that the 

application of the proposed regulatory 

language for hospitals may be 

inappropriate or overly burdensome for 

some providers and suppliers, we have 

used the proposed hospital 

requirements as a template for our 

proposed emergency preparedness 

regulations for other providers and 

suppliers but have specific proposed 

requirements tailored to each providers’ 

and suppliers’ unique needs. Any 

contracted services furnished to patients 

must be in compliance with all the 

facilities’ CoPs and standards of this 

rule, and all services must be provided 

in a safe and effective manner. 

All providers and suppliers would be 

required to establish an emergency 

preparedness plan that addressed the 

four core elements noted previously. 

The proposed requirements vary based 

on the type of provider. We discuss the 

hospital requirements in detail at the 

beginning of this section. The 

subsequent discussion of the proposed 

requirements for all remaining providers 

and suppliers focuses on how the 

requirements differ from those proposed 

for hospitals and why. 

For example, because they are 

inpatient facilities, religious nonmedical 

health care institutions (RNHCIs), 

psychiatric residential treatment 

facilities (PRTFs), skilled nursing 

facilities and nursing homes (referred to 

in this document as long term care 

(LTC) facilities), intermediate care 

facilities individuals with intellectual 

disabilities (ICFs/IID), and critical 

access hospitals (CAHs) may have 

greater responsibility than outpatient 

facilities during an emergency for 

ensuring the health and safety of 

persons for whom they provide care, 


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their employees, and volunteers. Thus, 

proposed requirements for RNHCIs, 

PRTFs, ICFs/IID, LTC facilities, and 

CAHs are similar to those proposed for 

hospitals. 

In the event of a natural or man-made 

disaster, providers and suppliers of 

outpatient services, such as ambulatory 

surgical centers (ASCs), programs of allinclusive care for the elderly (PACE) 

organizations, home health agencies 

(HHAs), comprehensive outpatient 

rehabilitation facilities (CORFs), rural 

health clinics (RHCs), federally 

qualified health centers (FQHCs), and 

end stage renal disease (ESRD) facilities, 

may not open their facilities or may 

close them, sending patients and staff 

home or to a place where they can safely 

shelter in place. However, we recognize 

that outpatient facilities may find it 

necessary to shelter their patients until 

they can be evacuated or may be called 

upon to provide some level of care for 

community residents in the event of an 

emergency. For example, a CORF that is 

housed in a large building may open its 

doors to persons in the community who 

would otherwise have no place to go. 

The CORF may provide only shelter 

from the elements or may provide water, 

food, and basic self-care items, if 

available. 

Finally, given that some hospice 

facilities provide both inpatient and 

home based services, and that transplant 

centers and OPOs are unique in their 

provision of health care, our proposed 

requirements are tailored even more 

specifically to address the 

circumstances of these entities. We 

believe lessons learned following the 

2005 hurricanes and subsequent 

disasters, such as the flooding in the 

Midwest in 2008, and the tornadoes and 

flooding in 2011 and 2012, have 

provided us with an opportunity to 

work collaboratively with the health 

care community to ensure best practices 

in emergency preparedness across 

providers and suppliers. 

It is important to point out that we 

expect that implementation of certain 

requirements that we propose for 

providers and suppliers would be 

different, based on the category of the 

provider or supplier. For example, we 

propose that nearly all providers and 

suppliers would be required to have 

policies and procedures to provide 

subsistence needs to staff and patients 

during an emergency. However, a small 

RHC’s implementation of this 

requirement would be quite different 

from a large metropolitan hospital’s 

implementation. Specifically, with 

respect the proposed requirement that 

hospitals, CAHs, inpatient hospice 

facilities, PRTFs, LTC facilities, ICFs/

IID, and RNHCIs would be required to 

maintain various subsistence needs, we 

are requesting public comment 

regarding whether this should be a 

requirement and in what quantities and 

for what time period these subsistence 

needs would be maintained. 

Nevertheless, we expect that each 

facility would determine how to 

implement a requirement considering 

similar variables such as whether the 

provider might have the option of 

notifying staff and patients not to come 

to the facility due to an emergency; the 

number of staff and patients likely to be 

in the facility at the time of an 

emergency; whether the provider would 

have the capability of providing shelter, 

provisions, and health care to members 

of the community; and the amount of 

space within the facility available for 

storing provisions. Although various 

providers and suppliers utilize different 

nomenclature to describe the 

individuals for whom they provide care 

(patient, resident, client, or participant), 

unless otherwise indicated, we will use 

the term ‘‘patients’’ to refer to the 

individuals for whom the provider or 

supplier under discussion provides 

care. 

Data regarding the number of 

providers cited in this proposed rule 

were obtained from a variety of different 

CMS databases. The number of 

providers and suppliers deemed by 

accrediting organizations to meet the 

Medicare conditions of participation are 

from CMS’s second quarter fiscal year 

2010 Accrediting Organization System 

for Storing User Recorded Experiences 

(ASSURE) database. Currently, there are 

accrediting organizations with Medicare 

deeming authority for hospitals, critical 

access hospitals, HHAs, hospices, and 

ASCs. 

Data for CAHs that report having 

psychiatric and rehabilitation Distinct 

Part Units (DPUs) are from the Medicare 

Quality Improvement and Evaluation 

System (QIES)/Certification and the 

Survey Provider Enhanced Reporting 

(CASPER) system as of March 2013. 

Data for CAHs that do not have DPUs 

are from the Online Survey, 

Certification, and Reporting (OSCAR) 

data system as of March 2013. Data for 

the number of transplant centers are 

from the CMS Web site as of March 

2013. Data for the total number of 

accredited and non-accredited hospitals, 

HHAs, ASCs, hospices, RHNCHIs, 

PRTFs, SNFs, ICFs/IID, CORFs, OPOs, 

and RHCs/FQHCs are from the OSCAR 

data system as of March 2013. We 

acquired the PACE data from CMS’s 

Health Plan Management System 

(HPMS), which reports the number of 

PACE contracts. Given that PACE 

organizations may have more than one 

‘‘center,’’ we are using the number of 

PACE contracts as a reflection of the 

number of PACE centers under contract 

with the CMS. 

Note that the CMS OSCAR data 

system is updated periodically by the 

individual states. Due to variations in 

the timeliness of the data submissions, 

all numbers are approximate, and the 

number of accredited and nonaccredited facilities shown may not 

equal the total number of facilities. 

Discussion of the proposed regulatory 

provisions for each type of provider and 

supplier follows the discussion in this 

section of the hospital requirements in 

the order in which they would appear 

in the Code of Federal Regulations 

(CFR). However, our discussion of the 

hospital requirements includes a general 

discussion of the differences between 

our proposed requirements, based on 

whether providers and suppliers 

provide outpatient services or inpatient 

services or both. Thus, we encourage all 

providers to read the discussion of the 

proposed hospital emergency 

preparedness requirements in section 

II.A. of this proposed rule. 

This section also provides detailed 

discussion of each proposed hospital 

requirement, offers resources that 

providers and suppliers can use to meet 

these proposed requirements, offers a 

means to establish and maintain 

emergency preparedness for their 

facilities, and provides links to guidance 

materials and toolkits that can be used 

to help meet these requirements. 

A. Emergency Preparedness Regulations 

for Hospitals (§ 482.15) 

Section 1861(e) of the Act defines the 

term ‘‘hospital’’ and subsections (1) 

through (8) list requirements that a 

hospital must meet to be eligible for 

Medicare participation. Section 

1861(e)(9) of the Act specifies that a 

hospital must also meet such other 

requirements as the Secretary finds 

necessary in the interest of the health 

and safety of individuals who are 

furnished services in the institution. 

Under the authority of 1861(e) of the 

Act, the Secretary has established in 

regulations at 42 CFR part 482 the 

requirements that a hospital must meet 

to participate in the Medicare program. 

Section 1905(a) of the Act provides 

that Medicaid payments may be applied 

to hospital services. Regulations at 

§ 440.10(a)(3)(iii) require hospitals to 

meet the Medicare conditions of 

participation (CoPs) to qualify for 

participation in Medicaid. The hospital 

CoPs are found at § 482.1 through 

§ 482.66. 


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As of September 2012, 4,928 hospitals 

participated in Medicare. CAHs that 

have distinct part units (DPUs) must 

comply with all of the hospital CoPs 

with respect to those units. There are 

1,332 active CAHs. Of these CAHs, there 

are 95 CAHs with DPUs. The remainder 

of CAHs (the vast majority) are not 

subject to hospital CoPs, and must 

comply with CAH-specific CoPs. 

Proposed requirements for CAHs are 

laid out in § 485.625. 

Services provided by hospitals 

encompass inpatient and outpatient care 

for persons with various acute or 

chronic medical or psychiatric 

conditions, including patient care 

services provided in the emergency 

department. Hospitals are the focal 

points for health care in their respective 

communities; thus, it is essential that 

hospitals have the capacity to respond 

in a timely and appropriate manner in 

the event of a natural or man-made 

disaster. Additionally, since Medicareparticipating hospitals are required to 

evaluate and stabilize every patient seen 

in the emergency department and to 

evaluate every inpatient at discharge to 

determine his or her needs and to 

arrange for post-discharge care as 

needed, hospitals are in the best 

position to coordinate emergency 

preparedness planning with other 

providers and suppliers in their 

communities. 

We are proposing a new requirement 

under 42 CFR 482.15 that would require 

that hospitals have both an emergency 

preparedness program and an 

emergency preparedness plan. 

Conceptually, an emergency 

preparedness program encompasses an 

approach to emergency preparedness 

that allows for continuous building of a 

comprehensive system of health care 

response to a natural or man-made 

emergency. We are also proposing that 

a hospital, and all other providers and 

suppliers, utilize an ‘‘all-hazards’’ 

approach in the preparation and 

delivery of emergency preparedness 

services in order to meet the health and 

safety needs of its patient population. 

The definition of ‘‘all hazards’’ is 

discussed later in this section under 

‘‘Emergency Plan.’’ 

We would expect that during an 

emergency, injured and ill individuals 

would seek health care services at a 

hospital or CAH, rather than from 

another provider or supplier. For 

example, during a pandemic, 

individuals with influenza-like 

symptoms are more likely to visit a 

hospital or CAH emergency department 

than an ASC. Typically, in the event of 

a chemical spill, affected individuals 

would not expect to receive emergency 

health care services at an LTC facility 

but would seek health care services at 

the hospital or CAH in their community. 

However, we believe it is imperative 

that each provider think in broader 

terms than their own facility, and plan 

for how they would serve similar and 

other healthcare facilities, as well as the 

whole community during and 

surrounding an emergency event. We 

believe the first step in emergency 

management is to develop an emergency 

plan. An emergency plan sets forth the 

actions for emergency response based 

on a risk assessment that addresses an 

‘‘all-hazards approach’’ to medical and 

non-medical emergency events. In 

keeping with the emergency 

management industry and with strong 

recommendation from the Department’s 

Assistant Secretary for Preparedness 

and Response (ASPR), we are proposing 

that all providers utilize an all-hazards 

approach to emergency response. We do 

not specify the quantity or the expected 

level of detail in which each hazard 

would be addressed by each provider; 

however, we do believe it would 

encourage the adoption of a well 

thought out, cohesive system of 

response both within and across 

provider types. 

Analysis of anticipated outcomes to 

the facility-based and community-based 

risk assessments would drive revision to 

the emergency preparedness program, 

the plan for response, or both. A facilitybased 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 allhazards planning scenarios, entitled the 

‘‘National Planning Scenarios’’ for use 

in federal, state, and local homeland 

security preparedness activities. These 

scenarios serve as planning tools for 

response to the range of man-made and 

natural disasters the nation could face. 

The scenarios are: nuclear detonationimprovised 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-aboutpresidential-policy-directive8#MajorElements. 

These planning tools along with other 

emergency management and business 

continuity information can be found on 

HRSA’s Web site at: http://

www.hrsa.gov/emergency/ and also in 

HRSA’s, Policy Information Notice 

entitled, ‘‘Health Center Emergency 

Management Program Expectations,’’ 

(No. 2007–15), dated August 22, 2007, 

at: http://bphc.hrsa.gov/

policiesregulations/policies/pin200715

expectations.html). While these 

materials were developed for health 

centers, the content is relevant to all 

health providers. According to the 

notice emergency management planning 

is to ensure predictable staff behavior 

during a crisis, provide specific 

guidelines and procedures to follow and 

define specific roles. Also, emergency 

planning should address the four phases 

of emergency management that include: 

mitigation activities to lessen the 

severity and impact a potential disaster 

or emergency might have on a health 

center’s operation; preparedness 

activities to build capacity and identify 

resources that may be used should a 

disaster or emergency occur; response to 

the actual emergency and controls the 

negative effects of emergency situations; 

and recovery that begin almost 

concurrently with response activities 

and are directed at restoring essential 

services and resuming normal 

operations to sustain the long-term 

viability of the health center. HRSA 

further states that for FQHCs, this means 

protecting staff and patients, as well as 

safeguarding the facility’s ability to 

deliver health care. According to HRSA, 

the expectations outlined in their 

guidance are intended to be broad to 

ensure applicability to the diverse range 

of centers and to aid integration of the 

guidance into what centers already are 

doing related to emergency and risk 

management. While this guidance is 

targeted toward centers, we believe 

hospitals and all other providers and 

suppliers can use this guidance in the 


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development of their emergency 

preparedness plans. 

The Agency for Healthcare Research 

and Quality (AHRQ) released a webbased interactive tool entitled, ‘‘Surge 

Tool Kit and Facility Checklist’’ (located 

at: http://www.cdc.gov/phpr/healthcare/ 

documents/shuttools.pdf or at: http://

archive.ahrq.gov/research/shuttered/

toolkitchecklist/), which will allow 

hospitals and emergency planners to 

estimate the resources needed to treat a 

surge of patients resulting from a major 

disaster, such as an influenza pandemic 

or a terrorist attack. Designed to dovetail 

with the Homeland Security Council’s 

15 all-hazards National Planning 

Scenarios, previously discussed, the 

AHRQ Hospital Surge Model allows 

users to select a disaster scenario and 

estimate the number of patients needing 

medical attention by arrival condition 

and day; the number of casualties in the 

hospital by unit and day; and the 

cumulative number of both dead or 

discharged casualties by day. The tool 

also calculates the level of hospital 

resources, including personnel, 

equipment and supplies, needed to treat 

patients. The model estimates resources 

for biological, chemical, nuclear or 

radiological attacks. (For the 

development of emergency 

preparedness plans, providers and 

suppliers may also find the National 

Fire Protection Association’s (NFPA) 

NFPA 1600: ‘‘Standard on Disaster/

Emergency Management and Business 

Continuity Programs, 2013 Edition,’’ 

particularly helpful. The NFPA 

document can be found at: http://

www.nfpa.org/aboutthecodes/

AboutTheCodes.asp?DocNum=1600. 

The standard sets forth the basic criteria 

for a comprehensive program that 

addresses disaster recovery, emergency 

management, and business continuity. 

Under most definitions, the NFPA 1600 

is an industry standard for disaster 

management. 

Also of concern when developing an 

emergency plan is the issue of the 

allocation of scarce resources during a 

potentially devastating event. Disasters 

can create situations where such 

resources must be distributed in a 

manner that is different from usual 

circumstances, but still appropriate to 

the situation. As discussed in 

‘‘Providing Mass Medical Care with 

Scarce Resources: A Community 

Planning Guide, Publication No. 07– 

0001, Rockville, MD: Agency for 

Healthcare Research and Quality,’’ 

(found at: http://archive.ahrq.gov/

research/mce/), such resource 

considerations are part of the impact 

that natural or man-made disasters have 

on hospitals. This guide provides 

information on the circumstances that 

communities would likely face as a 

result of a mass casualty event (MCE); 

key constructs, principles, and 

structures to be incorporated into the 

planning for an MCE; approaches and 

strategies that could be used to provide 

the most appropriate standards of care 

possible under the circumstances; 

examples of tools and resources 

available to help states and 

communities in their planning 

processes; and illustrative examples of 

how some health systems, communities, 

or states have approached certain issues 

as part of their MCE-related planning 

efforts. Building on the work from 2008, 

the Institute of Medicine (IOM) released 

in 2012 a guidance report entitled ‘‘The 

Crisis Standards of Care (CSC): A 

Systems Framework for Catastrophic 

Disaster Response’’ available at: http:// 

www.iom.edu/Reports/2012/CrisisStandards-of-Care-A-SystemsFramework-for-Catastrophic-DisasterResponse.aspx. The guidance report 

expanding upon prior scarce resources 

reports and defined crisis standards of 

care as ‘‘the optimal level of health care 

that can be delivered during a 

catastrophic event, requiring a 

substantial change in usual health care 

operations.’’ The report stated that CSC; 

provides a mechanism for responding to 

situations in which the demand on 

needed resources far exceeds the 

resource availability (that is, scarce 

resources); implementation of CSC 

involves a substantial shift in normal 

health care activities and reallocation of 

staff, facilities, and resources; and that 

to transition quickly and effectively, 

each organization and agency has a 

responsibility to plan and identify in 

advance the core functions it must carry 

out in a crisis and who will be 

responsible for each task. 

Another resource that would be useful 

in helping planners address the issues 

associated with preparing for and 

responding to an MCE in the context of 

broader emergency planning processes 

is the document entitled, ‘‘Standing 

Together: An Emergency Planning 

Guide for America’s Communities’’ 

(published by The Joint Commission 

(TJC), formerly known as the Joint 

Commission on the Accreditation of 

Healthcare Organizations, 2006). The 

document by TJC is a comprehensive 

resource that offers step-by-step 

guidance for development of an 

emergency preparedness plan that is 

applicable to small, rural, and suburban 

communities. This document can be 

found at: http:// 

www.jointcommission.org/Standing_

Together__An_Emergency_Planning_

Guide_for_Americas_Communities/. 

This document may be particularly 

useful for small or rural facilities and 

agencies. 

Rural communities face challenges in 

the delivery of health care that are often 

very different from those faced by urban 

and suburban communities. While rural 

communities depend on public health 

departments, hospitals, and emergency 

medical services (EMS) providers just as 

urban and suburban communities do, 

rural communities tend to have fewer 

health care resources overall. A report 

entitled, ‘‘Rural Communities and 

Emergency Preparedness,’’ (published 

by the Health Resources and Services 

Administration’s (HRSA) Office of Rural 

Health Policy, April 2002, found at: 

ftp://ftp.hrsa.gov/ruralhealth/Rural

Preparedness.pdf) addresses the issues 

faced by rural communities with respect 

to emergency preparedness. 

The authors report that there are 

many factors that limit the ability of 

rural providers and suppliers to deliver 

optimal health care services in the event 

of a natural or man-made disaster. The 

authors found that geographic isolation 

is a significant barrier to providing a 

coordinated emergency response. Rural 

areas are also more affected by 

variations in weather conditions and by 

seasonal variations in populations (for 

instance, tourism). As reported by the 

authors, these areas have fewer human 

and technical resources (that is, health 

care professionals, medical equipment, 

and communication systems). 

For example, the study found that in 

2002, only 20 percent of the 3,000 local 

public health departments in the United 

States had developed a plan to deal with 

a bioterrorism event. The researchers 

also found that the majority of rural 

public health agencies are closed 

evenings and weekends, and are not 

equipped to respond to an emergency 

situation on a 24-hour basis. While 

these factors may not affect a rural 

hospital directly, as an integral part of 

the larger system of health care delivery 

for its community, a hospital must be 

ready to manage the surge of persons 

who would seek care at the hospital 

during and after a disaster when many 

smaller health care entities may be nonoperational. 

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, 


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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, allhazards planning does not specifically 

address every possible threat but 

ensures that hospitals and all other 

providers will have the capacity to 

address a broad range of related 

emergencies. 

It is imperative that hospitals perform 

all-hazards risk assessment consistent 

with the concepts outlined in the 

National Preparedness Guidelines, the 

‘‘Guidelines’’ published by the U.S. 

Department of Homeland Security that 

we described in section I.A.3 of this 

proposed rule. Additional guidance and 

resources for assistance with designing 

and performing a hazard vulnerability 

assessment include: the Comprehensive 

Preparedness Guide 201: Threat and 

Hazard Identification and Risk 

Assessment Guide (available at: http:// 

www.fema.gov/library/

viewRecord.do?fromSearch=from

search&id=5823), the Use of Threat and 

Hazard Identification and Risk 

Assessment for Preparedness Grants 

(available at: http://www.fema.gov/

library/viewRecord.do?from

Search=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=from

search&id=5825), the Hazard Risk 

Assessment Instrument Workbook 

(available at: http://www.cphd.ucla.edu/ 

hrai.html) and the Understanding Your 

Risks: Identifying Hazards and 

Estimating Losses document (available 

at: http://www.fema.gov/library/

viewRecord.do?id=1880). 

Additionally, AHRQ published two 

additional guides to help hospital 

planners and administrators make 

important decisions about how to 

protect patients and health care workers 

and assess the physical components of 

a hospital when a natural or manmade 

disaster, terrorist attack, or other 

catastrophic event threatens the 

soundness of a facility. The guides 

examine how hospital personnel have 

coped under emergency situations in 

the past to better understand what 

factors should be considered when 

making evacuation, shelter-in-place, and 

reoccupation decisions. 

The guides entitled, ‘‘Hospital 

Evacuation Decision Guide’’ and 

‘‘Hospital Assessment and Recovery 

Guide’’ are intended to supplement 

hospital emergency plans, augment 

guidance on determining how long a 

decision to evacuate may be safely 

deferred, and provide guidance on how 

to organize an initial assessment of a 

hospital to determine when it is safe to 

return after an evacuation. 

The evacuation guide distinguishes 

between ‘‘pre-event evacuations’’ which 

are undertaken in advance of an 

impending disaster, such as a storm, 

when the hospital structure and 

surrounding environment are not yet 

significantly compromised and ‘‘postevent evacuations,’’ which are carried 

out after a disaster has damaged a 

hospital or the surrounding community. 

It draws upon past events including: the 

Northridge, CA, earthquake of 1994; the 

Three Mile Island nuclear reactor 

incident of 1979; and Hurricanes 

Katrina and Rita in 2005. The guide 

offers advice regarding sequence of 

patient evacuation and factors to 

consider when a threat looms. 

The assessment and recovery guide 

helps hospitals determine when to get 

back into a hospital after an evacuation. 

Comprised primarily of a 45-page 

checklist, the guide covers 11 separate 

areas of hospital infrastructure that 

should be evaluated before determining 

that it is safe to reoccupy a facility, such 

as security and fire safety, information 

technology and communication and 

biomedical engineering. 

The ‘‘Hospital Evacuation Decision 

Guide’’ can be found at: http:// 

archive.ahrq.gov/prep/hospevacguide/) 

(AHRQ Publication No. 10–0009), and 

the ‘‘Hospital Assessment and Recovery 

Guide’’ can be found at (http:// 

archive.ahrq.gov/prep/hosprecovery/) 

(AHRQ Publication No. 10–0081). 

Based on the guidance and 

information in these resources, we 

would expect a hospital’s risk 

assessment, which we would require at 

§ 482.15(a)(1), to be based on and 

include a documented, facility-based 

and community-based risk assessment, 

utilizing an all hazards approach. In 

order to meet this requirement, we 

would expect hospitals to consider, 

among other things, the following—(1) 

Identification of all business functions 

essential to the hospitals operations that 

should be continued during an 

emergency; (2) identification of all risks 

or emergencies that the hospital may 

reasonably expect to confront; (3) 

identification of all contingencies for 

which the hospital should plan; (4) 

consideration of the hospital’s location, 

including all locations where the 

hospital delivers patient care or services 

or has business operations; (5) 

assessment of the extent to which 

natural or man-made emergencies may 

cause the hospital to cease or limit 

operations; and (6) determination of 

whether arrangements with other 

hospitals, other health care providers or 

suppliers, or other entities might be 

needed to ensure that essential services 

could be provided during an emergency. 

We propose at § 482.15(a)(2) that the 

emergency plan include strategies for 

addressing emergency events identified 

by the risk assessment. For example, a 

hospital in a large metropolitan city may 

plan to utilize the support of other large 

community hospitals as alternate 

placement sites for its patients if the 

hospital needs to be evacuated. 

However, we would expect the hospital 

to have back-up evacuation plans for 

circumstances in which nearby 

hospitals also were affected by the 

emergency and were unable to receive 

patients. We would expect these plans 

to include consideration for how the 

hospital would work in collaboration 

with hospitals and other providers and 

suppliers across state lines, if 

applicable. Individuals who live near 

the border with an adjoining state could 

use the services of a hospital located in 

the adjoining state if the hospital was 

closer or provided more services than 

the nearest hospital in the state in 

which the individual resides. Therefore, 

we would encourage hospitals in 

adjoining states to work together to 

formulate plans to provide services 

across state lines in the event of a 

natural or man-made disaster to ensure 

continuity of care during a disaster. 


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c. Patient Population and Available 

Services 

At § 482.15(a)(3), we propose that a 

hospital’s emergency plan address its 

patient population, including, but not 

limited to, persons at-risk. As defined 

by the PAHPA, members of at-risk 

populations may have additional needs 

in one or more of the following 

functional areas: maintaining 

independence, communication, 

transportation, supervision, and medical 

care. In addition to those individuals 

specifically recognized as at-risk in the 

statute (children, senior citizens, and 

pregnant women), we are proposing to 

define ‘‘at-risk populations’’ as 

individuals who may need additional 

response assistance including those who 

have disabilities, live in 

institutionalized settings, are from 

diverse cultures, have limited English 

proficiency or are non-English speaking, 

lack transportation, have chronic 

medical disorders, or have 

pharmacological dependency. Also, as 

discussed in ‘‘Providing Mass Medical 

Care with Scarce Resources: A 

Community Planning Guide,’’ (http://

archive.ahrq.gov/research/mce/), at-risk 

populations would include, but are not 

limited to, the elderly, persons in 

hospitals and nursing homes, people 

with physical and mental disabilities, 

and infants, and children. Hospitals 

may find this resource helpful in 

establishing emergency plans that 

address the needs of such patients. 

We also propose at § 482.15(a)(3) that 

a hospital’s emergency plan address the 

types of services that the hospital would 

be able to provide in an emergency. The 

hospital should base these 

determinations on factors such as the 

number of staffed beds, whether the 

hospital has an emergency department 

or trauma center, availability of staffing 

and medical supplies, the hospital’s 

location, and its ability to collaborate 

with other community resources during 

an emergency. 

d. Succession Planning and Cooperative 

Efforts 

In regard to emergency preparedness 

planning, we are also proposing at 

§ 482.15(a)(3) that all hospitals include 

delegations and succession planning in 

their emergency plan to ensure that the 

lines of authority during an emergency 

are clear and that the plan is 

implemented promptly and 

appropriately. 

Finally, at § 482.15(a)(4), we propose 

that a hospital have a process for 

ensuring cooperation and collaboration 

with local, tribal, regional, state, or 

federal emergency preparedness 

officials’ efforts to ensure an integrated 

response during a disaster or emergency 

situation, including documentation of 

the hospital’s efforts to contact such 

officials and, when applicable, its 

participation in collaborative and 

cooperative planning efforts. We believe 

that planning with officials in advance 

of an emergency to determine how such 

collaborative and cooperative efforts 

will be achieved will foster a smoother, 

more effective, and more efficient 

response in the event of a disaster. 

While we are aware that the 

responsibility for ensuring a 

coordinated disaster preparedness 

response lies upon the state and local 

emergency planning authorities, the 

hospital would need to document its 

efforts to contact these officials and 

inform them of the hospital’s 

participation in the coordinated 

emergency response. Although we 

propose to require the same efforts for 

all providers and suppliers as we 

propose for hospitals, we realize that 

federal, state, and local officials may not 

elect to collaborate with some providers 

and suppliers due to their size and role 

in the community. For example, a 

RNHCI, by the limited nature of its 

service within the community, may not 

be called upon to participate in such 

collaborative and cooperative planning 

efforts. In this instance, we are 

proposing that such a provider or 

supplier would only need to provide 

documentation of its efforts to contact 

such officials and, when applicable, its 

participation. 

Through the work of its state partners, 

the ASPR Hospital Preparedness 

Program (HPP) has advanced the 

preparedness of hospitals and 

communities in numerous ways, 

including building healthcare 

coalitions, planning for all hazards, 

increasing surge capacity, tracking the 

availability of beds and other resources 

using electronic systems, and 

developing communication systems that 

are interoperable with other response 

partners. Many more community 

healthcare facilities have equipment to 

protect healthcare workers and 

decontaminate patients in chemical, 

biological, radiological, or nuclear 

emergencies. 

While the HPP program continues to 

encourage preparedness at the hospital 

level, evidence and real-world events 

have illustrated that hospitals cannot be 

successful in response without robust 

community healthcare coalition 

preparedness—engaging critical 

partners. Critical partners include 

emergency management, public health, 

mental/behavioral health providers, as 

well as community and faith-based 

partners. Together these partners make 

up a community’s Healthcare Coalition 

(HCC). A key goal of HPP moving 

forward is to strengthen the capabilities 

of the HCC, not just the individual 

hospital. HCCs are a cornerstone for the 

HPP and an integral component for 

community-wide planning for 

healthcare resiliency. 

We are aware that, among some 

emergency management leaders, 

healthcare coalitions are viewed as a 

valued and essential component of a 

coordinated system of response and that 

many providers now participate in such 

coalitions. While we are not requiring 

that providers participate in coalitions, 

we do recognize and support their value 

in the well-coordinated emergency 

response system and encourage 

providers of all types and sizes to 

engage in such collaborations, where 

possible, to ensure better coordination 

in planning, including the assessment of 

risk, surrounding an emergency event. 

The primary goal of health care 

coalitions is to foster collaboration 

amongst provider types in order to 

strengthen the overall health system by 

leveraging expertise, sharing resources, 

and increasing capacity to respond; thus 

reducing potential administrative 

burden for emergency preparedness, 

while similarly enabling easier 

emergency response integration and 

coordination during an emergency. 

Healthcare coalition activities provide, 

at a minimum, an optimal forum for: 

Leveraging leadership and operational 

expertise (health, public health, 

emergency management, public works, 

public safety, etc.) within a community; 

conducting mutual hazard 

vulnerability/risk assessments to 

identify community health gaps and 

develop plans and strategies to address 

them; developing standardized tools, 

emergency plans, processes and 

protocols, training and exercises to 

support the community and support 

ease of integration; and facilitating 

timely and/or shared resource 

management and coordination of 

communications and information 

during an emergency 

2. Policies and Procedures 

We are proposing at § 482.15(b) that a 

hospital be required to develop and 

implement emergency preparedness 

policies and procedures based on the 

emergency plan proposed at § 482.15(a), 

the risk assessment proposed at 

§ 482.15(a)(1), and the communication 

plan proposed at § 482.15(c). These 

policies and procedures would be 

reviewed and updated at least annually. 

We are soliciting public comment on the 

timing of the updates. 


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79096 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

We propose at § 482.15(b)(1) that a 

hospital’s policies and procedures 

would have to address the provision of 

subsistence needs for staff and patients, 

whether they evacuated or sheltered in 

place, including, but not limited to, at 

(b)(1)(i), food, water, and medical 

supplies. Analysis of the disaster caused 

by the hurricanes in the Gulf states in 

2005 revealed that hospitals were forced 

to meet basic subsistence needs for 

community evacuees, including visitors 

and volunteers who sheltered in place, 

resulting in the rapid depletion of 

subsistence items and considerable 

difficulty in meeting the subsistence 

needs of patients and staff. Therefore, 

we are proposing that a hospital’s 

policies and procedures also address 

how the subsistence needs of patients 

and staff who were evacuated would be 

met during an emergency. For example, 

a hospital might arrange for storage of 

supplies outside the facility, have 

contracts with suppliers for the 

acquisition of supplies during an 

emergency, or address subsistence 

needs for evacuees in an agreement with 

a facility that was willing to accept the 

hospital’s patients during an emergency. 

Based on our experience with 

hospitals, most hospitals do maintain 

subsistence supplies in the event of an 

emergency. Thus, we believe it would 

be overly prescriptive to require 

hospitals to maintain a defined quantity 

of subsistence needs for a defined 

period of time. We believe hospitals and 

other inpatient providers should have 

the flexibility to determine what is 

adequate based on the location and 

individual characteristics of the facility. 

Although we propose requiring only 

that each hospital addresses subsistence 

needs for staff and patients, we 

recommend that hospitals keep in mind 

that volunteers, visitors, and individuals 

from the community may arrive at the 

hospital to offer assistance or seek 

shelter and consider whether the 

hospital needs to maintain a store of 

extra provisions. We are soliciting 

public comment on this proposed 

requirement. 

As stated earlier, we also have learned 

from attendance in the Hurricane 

Katrina Sharing Information During 

Emergencies (SIDE) conference held in 

July of 2006, and from on-going 

participation in the CMS Survey & 

Certification (S&C) Emergency 

Preparedness Stakeholder 

Communication Forum, that many 

facilities placed back-up generators in 

basements that subsequently became 

inoperable due to water damage. In turn, 

this led to possible unsafe conditions for 

their patients and other persons 

sheltered in the facility. We note that 

existing regulations at § 482.41 require 

hospitals to have emergency power and 

lighting in certain areas (operating, 

recovery, intensive care, emergency 

rooms, and stairwells). Emergency 

lighting only in these areas will not 

assist staff if there is a requirement to 

continue operations for long periods of 

time with no power (for example, in the 

wards). Power outages lasted several 

days after Hurricane Sandy in some 

areas of the northeast. Similarly, should 

a large-scale evacuation be required, a 

lack of emergency lighting in general 

areas of the hospital such as wards and 

corridors would greatly hinder this 

process. This was of particular concern 

in impacted healthcare facilities during 

Hurricane Sandy (Redlener I, Reilly M, 

Lessons from Sandy—Preparing Health 

Systems for Future Disasters. N ENGL J 

MED. 367;24:2269–2271.) Thus, as 

previously stated, at § 482.15(b)(1)(ii) 

we also propose that the hospital have 

policies and procedures that address the 

provision of alternate sources of energy 

to maintain: (1) Temperatures to protect 

patient health and safety and for the safe 

and sanitary storage of provisions; (2) 

emergency lighting; (3) fire detection, 

extinguishing, and alarm systems. We 

are also proposing at 

§ 482.15(b)(1)(ii)(D) that the hospital 

develop policies and procedures to 

address provision of sewage and waste 

disposal. We are proposing to define the 

term ‘‘waste’’ as including all wastes 

including solid waste, recyclables, 

chemical, biomedical waste and 

wastewater, including sewage. These 

proposed requirements concern assuring 

the continuity of the power source for 

the fire detection, extinguishing and 

alarm systems and are an essential 

prerequisite for successful 

implementation of existing 

requirements during emergencies that 

result in loss of regular power. These 

proposed requirements are more in line 

with best practice rather than mere 

sufficiency. 

We are proposing at § 482.15(b)(2) 

that the hospital develop policies and 

procedures regarding a system to track 

the location of staff and patients in the 

hospital’s care both during and after an 

emergency. We believe it is imperative 

that the hospital be able to track a 

patient’s whereabouts, to ensure 

adequate sharing of patient information 

with other providers and to inform a 

patient’s relatives and friends of the 

patient’s location within the hospital, 

whether the patient has been transferred 

to another facility, or what is planned in 

respect to such actions. Therefore, we 

believe that hospitals must develop a 

means to track patients, which would 

include evacuees in the hospital’s care 

during and after an emergency event. 

ASPR has developed tools, programs 

and resources to facilitate disaster 

preparedness planning at the local 

healthcare facility-level. One of these 

tools, The Joint Patient Assessment and 

Tracking System (JPATS), was 

developed through an interagency 

association between HHS/ASPR and 

DoD, and is available for providers at: 

https://asprwebapps.hhs.gov/jpats/

protected/home.do. 

Use of the JPATS is referenced in 

Health Preparedness Capabilities: 

National Guidance for Health System 

Preparedness (2012). This document 

provides guidance for healthcare 

systems, healthcare coalitions and 

healthcare organizations emergency 

preparedness efforts that is intended to 

serve as a planning resource. Broad 

guidance as to the requirement for bed 

and patient tracking is included. 

Given the lessons learned, this 

requirement is being proposed for 

providers and suppliers who provide 

ongoing care to inpatients or 

outpatients. Such providers and 

suppliers would include RNHCIs, 

hospices, PRTFs, PACE organizations, 

LTC facilities, ICFs/IID, HHAs, CAHs, 

and ESRD facilities. Despite providing 

services on an outpatient basis, we 

would require hospices, HHAs, and 

ESRD facilities to assume this 

responsibility. These providers and 

suppliers maintain current patient 

census information and would be 

required to provide continuing patient 

care during the emergency. In addition, 

we would require ASCs to maintain 

responsibility for their staff and patients 

if patients were in the facility. Other 

outpatient providers, such as CORFs, 

FQHCs and clinics maintain patient 

information but they have the flexibility 

of cancelling appointments during an 

emergency thereby not needing to 

assume responsibility of the patients. 

This requirement is not being 

proposed for transplant centers; CORFs; 

OPOs; clinics, rehabilitation agencies as 

providers of outpatient physical therapy 

and speech-language pathology services; 

and RHCs/FQHCs. Transplant centers’ 

patients and OPOs’ potential donors 

would be in hospitals, and, thus, would 

be the hospital’s responsibility. We 

believe it is likely that outpatient 

providers and suppliers would close 

their facilities prior to or immediately 

after an emergency, sending staff and 

patients home. 

We are not proposing a requirement 

for a specific type of tracking system. A 

hospital would have the flexibility to 

determine how best to track patients 

and staff, whether it used an electronic 


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database, hard copy documentation, or 

some other method. However, it is 

important that the information be 

readily available, accurate, and 

shareable among officials within and 

across the emergency response system 

as needed in the interest of the patient. 

A number of states already have such 

tracking systems in place or under 

development and the systems are 

available for use by health care 

providers and suppliers. Lessons 

learned from the hurricanes in the Gulf 

States revealed that some facilities, 

despite having patient-related 

information backed up to computer 

databases within or outside of the state 

in which the disaster occurred, could 

not access the information in a timely 

manner. Therefore, we would 

recommend that a hospital using an 

electronic database consider backing up 

its computer system with a secondary 

source. 

Although we believe that it is 

important that a hospital, and other 

providers of critical care, be able to 

track a patient’s whereabouts to ensure 

adequate sharing of patient information 

with other providers and to inform a 

patient’s relatives of the patient’s 

location after a disaster, we are 

specifically soliciting comments on the 

feasibility of this requirement for any 

outpatient facilities. 

We propose at § 482.15(b)(3) that 

hospitals have policies and procedures 

in place to ensure the safe evacuation 

from the hospital, which would include 

standards addressing consideration of 

care and treatment needs of evacuees; 

staff responsibilities; transportation; 

identification of evacuation location(s); 

and primary and alternate means of 

communication with external sources of 

assistance. 

We propose at § 482.15(b)(4) that a 

hospital must have policies and 

procedures to address a means to shelter 

in place for patients, staff, and 

volunteers who remain in the facility. 

We expect that hospitals would include 

in their policies and procedures both 

the criteria for selecting patients and 

staff that would be sheltered in place 

and a description of the means that they 

would use to ensure their safety. 

During the Gulf Coast hurricanes, 

some hospitals were able to shelter their 

patients and staff in place. However, the 

physical structures of many other 

hospitals were so damaged that 

sheltering in place was impossible. 

Thus, when developing policies and 

procedures for sheltering in place, 

hospitals should consider the ability of 

their building(s) to survive a disaster 

and what proactive steps they could 

take prior to an emergency to facilitate 

sheltering in place or transferring of 

patients to alternate settings if their 

facilities were affected by the 

emergency. 

We propose at § 482.15(b)(5) that a 

hospital have policies and procedures 

that would require a system of medical 

documentation that would preserve 

patient information, protect the 

confidentiality of patient information, 

and ensure that patient records were 

secure and readily available during an 

emergency. In addition to the current 

hospital requirements for medical 

records located at § 482.24(b), we are 

proposing that hospitals be required to 

ensure that patient records are secure 

and readily available during an 

emergency. 

Such policies and procedures would 

have to be in compliance with Health 

Insurance Portability and 

Accountability Act (HIPAA) Privacy and 

Security Regulations at 45 CFR parts 

160 and 164, which protect the privacy 

and security of individual’s personal 

health information. Information on how 

HIPAA requirements can be met for 

purposes of emergency preparedness 

and response can be found at: http://

www.hhs.gov/ocr/privacy/hipaa/

understanding/special/emergency/

index.html. The tornadoes that occurred 

in Joplin, Missouri in 2011, presented 

an example of the value of electronic 

health records during a disaster. There 

were primary care clinics and other 

providers that had electronic health 

records and because their records were 

not destroyed, they were able to find 

new locations, contact their patients and 

re-establish operations very quickly. 

We propose at § 482.15(b)(6) that 

facilities would have to have policies 

and procedures in place to address the 

use of volunteers in an emergency or 

other emergency staffing strategies, 

including the process and role for 

integration of state or federally 

designated health care professionals to 

address surge needs during an 

emergency. 

Facilities may find it helpful to utilize 

assistance from the Medical Reserve 

Corps (MRC), a national network of 

community-based volunteer units that 

focus on improving the health, safety 

and resiliency of their local 

communities. MRC units organize and 

utilize public health, medical and other 

volunteers to support existing local 

agencies with public health activities 

throughout the year and with 

preparedness and response activities for 

times of need. One goal of the MRC is 

to ensure that members are identified, 

screened, trained and prepared prior to 

their participation in any activity. While 

MRC units are principally focused on 

their local communities, they have the 

potential to provide assistance in a 

statewide or national disaster as well. 

Hospitals could use the Emergency 

System for Advance Registration of 

Volunteer Health Professionals (ESAR– 

VHP), found in section 107 of the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(Pub. L. 107–188), to verify the 

credentials of volunteer health care 

workers. The ESAR–VHP is a federal 

program to establish and implement 

guidelines and standards for the 

registration, credentialing, and 

deployment of medical professionals in 

the event of a large-scale national 

emergency. The program is 

administered by ASPR within the 

Department. All states must participate 

in ESAR–VHP. 

The purpose of the program is to 

facilitate the use of volunteers at all tiers 

of response (local, regional, state, 

interstate, and federal). The ESAR–VHP 

program has been working to establish 

a national network of state-based 

programs that manage the information 

needed to effectively use health 

professional volunteers in an 

emergency. These state-based systems 

will provide up-to-date information 

regarding the volunteer’s identity and 

credentials to hospitals and other health 

care facilities in need of the volunteer’s 

services. Each state’s ESAR–VHP system 

is built to standards that will allow 

quick and easy exchange of health 

professionals with other states. We 

propose at § 482.15(b)(7) that hospitals 

would have to have a process for the 

development of arrangements with other 

hospitals and other providers to receive 

patients in the event of limitations or 

cessation of operations at their facilities, 

to ensure the continuity of services to 

hospital patients. 

We believe this requirement should 

apply only to providers and suppliers 

that provide continuous care and 

services for individual patients. Thus, 

we are not proposing this requirement 

for transplant centers; CORFs; OPOs; 

clinics, rehabilitation agencies, and 

public health agencies as providers of 

outpatient physical therapy and speechlanguage 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 


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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 waivereligible requirements may be 

reimbursed and exempted from 

sanctions (absent any determination of 

fraud or abuse). Requirements to which 

an 1135 waiver may apply include 

Medicare conditions of participation or 

conditions for coverage and 

requirements under the Emergency 

Medical Treatment and Labor Act 

(EMTALA). The 1135 waiver authority 

applies only to specific federal 

requirements and does not apply to any 

state requirements, including licensure. 

In determining whether to invoke an 

1135 waiver (once the conditions 

precedent to the authority’s exercise 

have been met), the ASPR with input 

from relevant HHS operating divisions 

(OPDIVs) determines the need and 

scope for such modifications, considers 

information such as requests from 

Governor’s offices, feedback from 

individual healthcare providers and 

associations, and requests from regional 

or field offices for assistance. Additional 

information regarding the 1135 waiver 

process is provided in the CMS Survey 

and Certification document entitled, 

‘‘Requesting an 1135 Waiver’’, and 

located at: http://www.cms.gov/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 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 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-hospitalbased 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: 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 


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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 wellcoordinated 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 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’’). 

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. 

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 


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to develop and maintain their own 

system. 

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 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 manmade 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 paperbased, 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, clinicallyrelevant 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 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 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/bhpptrain-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 afterevent 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 


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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). 

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 pilottested 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, userfriendly tool for health care providers to 

use to document their performance 

during emergency planning exercises 

and real emergency events to 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 operationsbased. 

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). 

• 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 multiagency 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 fullscale exercise is a multi-agency, multijurisdictional, multi-discipline exercise 

involving functional (for example, joint 

field office, emergency operation 

centers, etc.) and ‘‘boots on the ground’’ 

response (for example, 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, 


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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 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. 

TABLE 1—EMERGENCY PREPAREDNESS REQUIREMENTS BY PROVIDER TYPE

Provider type Emergency plan Policies and 

procedures Communication plan Training and testing Additional requirements 

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 wellcoordinated within 

the facility, across 

health care providers and with 

state and local public health departments and emergency systems.

*Develop and maintain training and 

testing programs, 

including initial 

training in policies 

and procedures 

and demonstrate 

knowledge of emergency procedures 

and provide training 

at least annually. 

Conduct drills and 

exercises to test 

the emergency plan.

Generators—Develop 

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. 

Critical Access Hospital.* ................................. * ................................. * ................................. * ................................. Generators. 

Long Term Care Facility.Must account for 

missing residents 

(existing requirement).

* ................................. Share with resident/

family/representative appropriate information from 

emergency plan 

(additional requirement).

* ................................. Generators. 

PRTF .......................... * ................................. * ................................. * ................................. * 

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 ...... * ................................. * ................................. * ................................. * ................................. Maintain agreement 

with transplant center & OPO. 

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.* .................................


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TABLE 1—EMERGENCY PREPAREDNESS REQUIREMENTS BY PROVIDER TYPE—Continued 

Provider type Emergency plan Policies and 

procedures Communication plan Training and testing Additional requirements 

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.* 

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 emergency preparedness tasks to new 

personnel. Provide 

instruction in location, use of alarm 

systems, signals & 

firefighting equip 

(existing requirements).

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 exercise.Must maintain agreement with other 

OPOs & hospitals. 

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.* 


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TABLE 1—EMERGENCY PREPAREDNESS REQUIREMENTS BY PROVIDER TYPE—Continued 

Provider type Emergency plan Policies and 

procedures Communication plan Training and testing Additional requirements 

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 demonstrate knowledge 

of emergency procedures, informing 

patients what to do, 

where to go, whom 

to contact if emergency occurs while 

patient is not in facility (alternate 

emergency phone 

number), how to 

disconnect themselves from dialysis 

machine. Staff 

maintain current 

CPR certification, 

nursing staff trained 

in use of emergency equipment & 

emergency drugs, 

patient orientation 

(existing requirements).

* Indicates that the requirements are the same as those proposed for hospitals. 

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 Medicarecertified 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 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 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), 


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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 

§ 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 ‘‘nonmedical’’ 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 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 manmade 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. 

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, nonlife-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), 


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(a)(1), (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), Public Law 97–248, added 

section 1861(dd) to the Act to provide 

coverage for hospice care to terminally 

ill Medicare beneficiaries who elect to 

receive care from a Medicareparticipating 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. 

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. 

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 manmade 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 


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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 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. 

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 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 AllInclusive 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. 

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 


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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 

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 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 includes 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 followup 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 

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 Medicareapproved 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 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 


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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 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. 

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 

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 

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 


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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. 

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 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 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. 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 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. 

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 


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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. 

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 nonresidential 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) 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 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 

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 


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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 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 wellcoordinated 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 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 Medicare- and 

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 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 

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 speechlanguage pathology services. In the 

remainder of this proposed rule and 

throughout the requirements, we use the 


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term ‘‘organizations’’ instead of ‘‘clinics, 

rehabilitation agencies, and public 

health agencies as providers of 

outpatient physical therapy and speechlanguage 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. 

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 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 Public Law 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. 

• 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 staff were in the 

facility when a disaster or emergency 

situation occurred, we would expect the 


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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 wellcoordinated 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 nextof-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 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. 

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. 

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 facility’s size, 

available human and material resources, 

geographic location, and ability to 

coordinate with community resources. 


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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 Web site 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 § 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 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 Medicareparticipating 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 ‘‘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, 


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including staff responsibilities and 

needs of the patients. 

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 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). 

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 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 


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determining the burden for this 

proposed rule, we did not take into 

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 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 

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/emergency

preparedness 

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-preparemitigate 

Department of Homeland Security 

(DHS) 

• http://www.dhs.gov/trainingtechnical-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 § 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 


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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. 

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 × 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 × 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 × 16 RNHCIs = 

192 burden hours) at a cost of $5,568 

($348 estimated cost for each RNHCI × 

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. 

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 × 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 × 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 × 16 RNHCIs = 64 burden hours) 

at a cost of $1,856 ($116 estimated cost 

for each RNHCI × 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 


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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 × 16 RNHCIs = 112 burden 

hours) at a cost of $3,488 ($218 

estimated cost for each RNHCI × 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 paperbased, 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 for each RNHCI × 16 RNHCIs = 48 

burden hours) at a cost of $1,152 ($72 

estimated cost for each RNHCI × 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 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 nonaccredited 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. 


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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 AAAHCaccredited ASCs + 350 TJC-accredited 

ASCs = 1,226 ASCs accredited by TJC or 

AAAHC) separately from the 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 TJC-accredited 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. 

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, facilitybased 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 TJCaccredited ASCs (5,354 total ASCs–350 

TJC-accredited ASCs = 5,004 non TJCaccredited 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 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 × 5,004 non TJC-accredited ASCs = 

40,032 burden hours) for all non TJCaccredited ASCs to comply with this 

risk assessment requirement at a cost of 

$2,386,908 ($477 estimated cost for each 

ASC × 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 TJC-accredited 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 negligible. Thus, for 350 TJCaccredited 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 TJCaccredited 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 


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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. 

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 × 5,004 non TJCaccredited ASCs = 55,044 burden hours) 

at a cost of $3,267,612 ($653 estimated 

cost for each non TJC-accredited ASC × 

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. 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), TJCaccredited 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 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 AAAHC-accredited 

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 TJCaccredited ASC × 5,004 non TJCaccredited ASCs = 45,036) at a cost of 

$2,527,020. ($505 estimated cost for 

each non TJC-accredited ASC × 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). 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 


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(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 TJC-accredited 

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 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 AAAHCaccredited ASCs in with the nonaccredited 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 TJCaccredited ASC × 5,004 non TJCaccredited ASCs = 20,016 burden hours) 

at a cost of $1,135,908 ($227 estimated 

cost for each non TJC-accredited ASC × 

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 

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 any requirements for training 

volunteers. Thus, TJC accreditation 

standards do not ensure that TJCaccredited 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. Therefore, the 

estimated annual burden for all 5,354 

ASCs to comply with these 

requirements is 32,124 burden hours (6 


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burden hours × 5,354 ASCs =32,124 

burden hours) at a cost of $1,761,466 

($329 estimated cost for each ASC × 

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 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 

AAAHC-accredited ASCs are already 

complying with these requirements. 

Therefore, the AAAHC-accredited 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 paperbased, 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 

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 × 5,354 

ASCs = 26,770 burden hours) at a cost 

of $1,488,412 ($278 estimated cost for 

each ASC × 5,354 ASCs = $1,488,412 

estimated cost). 

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 


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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 (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, 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 

× 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 × 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 

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 × 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 × 

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 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 


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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 × 1,189 

inpatient hospices = 16,646 burden 

hours) for all inpatient hospices to 

complete their plans at a cost of 

$882,238 ($742 estimated cost for each 

inpatient hospice × 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 × 2,584 hospices = 51,680 

burden hours) at a cost of $2,702,864 

($1,046 estimated cost for each hospice 

× 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 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 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 × 1,189 inpatient 

hospices = 9,512 burden hours) at a cost 

of $474,411 ($399 estimated cost for 

each inpatient hospice × 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. 

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 × 2,584 hospices 

= 23,256 burden hours) at a cost of 

$1,173,136 ($454 estimated cost for each 

hospice × 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 


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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 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 × 3,773 hospices = 11,319 

burden hours) at a cost of $622,545 

($165 estimated cost for each hospice × 

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. 

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 × 3,773 hospices = 22,638 

burden hours) at a cost of $950,796 

($252 estimated cost for each hospice × 

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. 

The associated burden would be the 

time and effort necessary for a hospice 

to comply with these requirements. We 

expect that complying with these 


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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 × 3,773 

hospices = 15,092 burden hours) at a 

cost of $633,864 ($168 estimated cost for 

each hospice × 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. Respond- ents 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. 

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 allhazards 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 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 × 387 PRTFs = 3,096 burden 

hours) at a cost of $152,478 ($394 

estimated cost for each PRTF × 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 × 387 PRTFs = 4,644 burden 

hours) for all PRTFs to comply with this 

requirement at a cost of $245,358 ($634 

estimated cost per PRTF × 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 


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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 (9 

burden hours for each PRTF × 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 × 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 

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 × 

387 PRTFs = 1,935 burden hours) at a 

cost of $110,682 ($286 estimated cost for 

each PRTF × 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. 

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 × 387 

PRTFs = 3,870 burden hours) at a cost 

of $178,020 ($460 estimated cost for 

each PRTF × 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 manmade 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, 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, 


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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 × 387 PRTFs = 1,161 burden 

hours) at a cost of $53,406 ($138 

estimated cost for each PRTF × 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 

($) 

§ 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)). 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 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 × 91 PACE 

organizations = 1,274 burden hours) at 

a cost of $69,251 ($761 estimated cost 

for each PACE organization × 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 


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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. 

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 × 91 PACE organizations = 

2,093 burden hours) at a cost of 

$112,749 ($1,239 estimated cost for each 

PACE organization × 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 

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 × 91 PACE organizations = 

1,092 burden hours) at a cost of $54,418 

($598 estimated cost for each PACE 

organization × 91 PACE organizations = 

$54,418 estimated cost). 

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. 

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 × 91 PACE organizations = 

637 burden hours) at a cost of $28,665 

($315 estimated cost for each PACE 

organization × 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. 


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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 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 × 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 × 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 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 manmade 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-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 × 91 PACE organizations = 

455 burden hours) at a cost of $20,475 

($225 estimated cost for each PACE 

organization × 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 

eporting 

($) 

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 

** The hourly labor cost is blended between the wages for multiple staffing levels. 


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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 nonaccredited 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 

performance (EPs) required for TJC 

accreditation. The TJC standards, 

rationales, and elements of performance 

(EPs) are on the TJC Web site 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 DNVHCaccredited 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 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, 

facility-based and community-based risk 

assessment, utilizing an all-hazards 

approach. We expect that most non TJCaccredited 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 followup meeting, perform a final review, and 

approve the new risk assessment. 

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 TJCaccredited hospitals × 1,518 non TJCaccredited 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 × 1,518 non TJCaccredited 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 ‘‘allVerDate Mar<15>2010 00:02 Dec 27, 2013 Jkt 232001 PO 00000 Frm 00053 Fmt 4701 Sfmt 4702 E:\FR\FM\27DEP2.SGM 27DEP2

sroberts on DSK5SPTVN1PROD with PROPOSALS
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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 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 TJCaccredited 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 TJCaccredited 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 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 × 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 × 

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. 

The CAMH’s chapter entitled, 

‘‘Leadership’’ (LD), requires TJCaccredited 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 TJCaccredited 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 nonmedical 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. TJCaccredited hospitals are required to 

make 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 


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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 TJCaccredited 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 hospitalspecific information (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. 

IM–8). 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. TJCaccredited 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 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 TJCaccredited 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 TJCaccredited 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 TJC-accredited 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 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 × 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 × 3,410 

TJC-accredited 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, 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. 


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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 × 

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 × 

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 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 × 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 × 

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 TJCaccredited 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. 

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 TJCaccredited 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 TJCaccredited 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 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 

e×pect 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 × 1,518 non 

TJC-accredited hospitals =15,180 

burden hours) at a cost of $1,149,126 

($757 estimated cost for each non TJCaccredited hospital × 1,518 non TJCaccredited 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 


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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). 

Proposed § 482.15(d)(1) would require 

hospitals to provide initial and 

thereafter annual training on their 

emergency preparedness policies and 

procedures to all new and 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 TJCaccredited 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. TJCaccredited hospitals also must provide 

on-going training to their staff, 

including training on specific jobrelated 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 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 TJC-accredited 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 $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 × 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 

× 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, facilitybased 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 

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 


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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 

TJC-accredited 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 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 nonTJC 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 TJCaccredited hospital × 1,518 non TJCaccredited hospitals =13,662 burden 

hours) at a cost of $793,914 ($523 

estimated cost for each non TJCaccredited hospital × 1,518 non TJCaccredited 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) (TJC-accredited) .............................. 0938—New .............. 3,410 3,410 17 57,970 ** 4,852,430 0 4,852,430 

§ 482.15(b) (Non TJC-accredited) ...................... 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 

transplant-related 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, 

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 


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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 × 770 

transplant centers = 11,550 burden 

hours) at a cost of $1,068,760 ($1,388 

estimated cost for each transplant center 

× 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 (15 burden hours for 

each hospital × 238 hospitals= 3,570 

burden hours) at a cost of $330,344 

($1,388 estimated cost for each hospital 

× 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. 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, facility-based and 

community-based risk assessment 

utilizing an all-hazard approach, 

including missing clients. We expect an 

ICF/IID to identify the medical and nonmedical emergency events it 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 


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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 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 × 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 × 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 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 × 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 × 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). 

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 


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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 × 6,442 ICFs/IID = 57,978 

burden hours) at a cost of $3,382,050 

($525 estimated cost for each ICF/IID × 

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. 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 

× 6,442 ICFs/IID = 38,652 burden hours) 

at a cost of $2,254,700 ($350 estimated 

cost for each ICF/IID × 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, 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 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 × 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 × 

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 manmade emergency that required 

activation of its emergency plan, the 

ICF/IID would be exempt from engaging 

in a community or individual, facilitybased mock disaster drill for 1 year 


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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 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 × 6,442 ICFs/IID = 25,768 

burden hours) at a cost of $1,211,096 

($188 estimated cost for each ICF/IID × 

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. Respond- ents 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 

§ 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 nonaccredited 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 

TJC-accredited 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 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 


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(CAMHC, Standard EC.2.10, p. EC–7). 

Moreover, TJC-accredited HHAs are 

required to develop and maintain ‘‘a 

written emergency management plan 

describing the process for disaster 

readiness and emergency management 

. . . ’’ (CAMHC, 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 TJCaccredited 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 TJC-accredited 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 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 TJC-accredited 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 TJCaccredited HHA × 10,615 non TJCaccredited HHAs = 116,765 burden 

hours) at a cost of $6,422,075 ($605 

estimated cost for each non TJCaccredited HHA × 10,615 non TJCaccredited 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 TJCaccredited 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 

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 TJC-accredited 

HHAs because we expect the burden for 

TJC-accredited HHAs to be substantially 

less. 

We expect that the 10,615 non TJCaccredited 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 × 1,734 TJCaccredited HHAs = 17,340 burden 

hours) at a cost of $946,764 ($546 

estimated cost for each HHA × 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 TJCaccredited HHAs at a cost of $819. 

Therefore, for all 10,615 non TJCaccredited HHAs to comply would 

require an estimated 159,225 burden 

hours (15 burden hours for each non 

TJC-accredited HHA × 10,615 non TJCaccredited HHAs = 159,225 burden 

hours) at a cost of $8,693,685 ($819 

estimated cost for each non TJCaccredited HHA × 10,615 non TJCaccredited 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 


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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 

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 TJCaccredited 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 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 TJC-accredited 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 × 12,349 HHAs = 222,282 burden 

hours) at a cost of $12,299,604 ($996 

estimated cost for each HHA × 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’’ (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. 

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 


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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 × 

12,349 HHAs = 123,490 burden hours) 

at a cost of $6,421,480 ($520 estimated 

cost for each HHA × 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 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 TJCaccredited 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 jobrelated aspects of safety . . .’’ (CAMHC, 

Standard HR.2.30, EP 4, p. HR–8). Since 

emergency preparedness is a critical 

aspect of job-related 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 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 × 12,349 

HHAs = 197,584 burden hours) at a cost 

of $9,335,844 ($756 estimated cost for 

each HHA × 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 manmade emergency that required 

activation of the 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. 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, TJC-accredited 

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 TJC-accredited 

HHAs would be in compliance with our 

proposed requirements. Therefore, we 

will include the 1,734 TJC-accredited 

HHAs with the 10,615 non TJCaccredited 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 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. 


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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) (TJC-accredited) ................... 0938—New .............. 1,734 1,734 10 17,340 ** 946,764 0 946,764 

§ 484.22(a)(1)–(4) (Non TJC-accredited) ............ 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. 

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 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 × 272 CORFs = 2,176 burden 

hours) for all CORFs to comply at a cost 

of $131,920 ($485 estimated cost for 

each CORF × 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 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 × 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 × 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 


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preparedness plans, and communication 

plans. Most CORFs would need to revise 

their existing policies and 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 × 272 CORFs = 2,448 burden 

hours) to comply with this requirement 

at a cost of $149,328 ($549 estimated 

cost for each CORF × 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; 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 × 

272 CORFs = 2,176 burden hours) for all 

CORFs to comply at a cost of $131,920 

($485 estimated cost for each CORF × 

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). 

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 

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 × 272 CORFs = 2,176 burden 

hours) at a cost of $131,920 ($485 

estimated cost for each CORF × 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 


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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 

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 × 272 CORFs = 

1,632 burden hours) at a cost of $99,552 

($366 estimated cost for each CORF × 

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. 

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, facility-based 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 nonaccredited CAHs. Many of the TJC and 

AOA accreditation 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 TJCaccredited and 32 AOA-accredited 

CAHs separately from the nonaccredited 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 nonaccredited 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 TJCaccredited CAHs, 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). 

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, AOAaccredited 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 AOA-accredited CAHs with nonVerDate Mar<15>2010 00:02 Dec 27, 2013 Jkt 232001 PO 00000 Frm 00068 Fmt 4701 Sfmt 4702 E:\FR\FM\27DEP2.SGM 27DEP2

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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 non-medical 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, facilitybased, and community-based risk 

assessment that would satisfy our 

proposed requirements. 

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 TJCaccredited CAHs to comply with the 

proposed risk assessment requirement 

would require 14,280 burden hours (15 

burden hours for each CAH × 952 non 

TJC-accredited CAHs = 14,280 burden 

hours) at a cost of $903,448 ($949 

estimated cost for each non TJCaccredited CAH × 952 non TJCaccredited CAHs = $903,448 estimated 

cost). 

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, TJC-accredited 

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 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 AOA-accredited 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 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 AOAaccredited CAHs = 952 non TJCaccredited CAHs) to comply with this 

requirement would require 24,752 

burden hours (26 burden hours for each 


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non TJC-accredited CAH × 952 non TJCaccredited CAHs = 24,752 burden 

hours) at a cost of $1,542,240 ($1,620 

estimated cost for each non TJCaccredited CAH × 952 non TJCaccredited 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 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 TJCaccredited 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. TJCaccredited 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). 

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. TJCaccredited 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 TJCaccredited 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. TJCaccredited 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. EC– 

10f). Therefore, we expect that TJCaccredited 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. 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, TJC-accredited 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. EC–10d and Standard EC.4.18, EP 

6, pp. EC–10g, respectively). Therefore, 

we expect that TJC-accredited 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 

the TJC accreditation requirements 

address some of our proposed 

requirements, we do not believe TJCaccredited 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 


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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 TJCaccredited 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. 

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 

(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 AOAaccredited 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 TJCaccredited CAHs in determining the 

burden. 

The burden for the 32 AOAaccredited CAHs and the 370 TJCaccredited 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 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 AOAaccredited CAHs to comply with these 

requirements would require an 

estimated 4,020 burden hours (10 

burden hours for each TJC or AOAaccredited CAH × 402 TJC and AOAaccredited CAHs = 4,020 burden hours) 

at a cost of $327,228 ($814 estimated 

cost for each TJC or AOA-accredited 

CAH × 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 


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individuals and 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 nonaccredited 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 nonaccredited CAHs × 920 non-accredited 

CAHs = 12,880 burden hours) at a cost 

of $791,200 ($860 estimated cost for 

each non-accredited CAH × 920 nonaccredited 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 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 TJC-accredited 

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 AOAaccredited 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. 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 × 1,322 

CAHs = 11,898 burden hours) at a cost 

of $686,118 ($519 estimated cost for 

each CAH × 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, 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 


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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 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 × 

1,322 CAHs = 18,508 burden hours) at 

a cost of $1,102,548 ($834 estimated 

cost for each CAH × 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). 

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, facilitybased 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). 

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 nonaccredited CAHs to comply with these 

requirements would require an 

estimated 7,360 burden hours (8 burden 

hours for each non-accredited CAH × 

920 non-accredited CAHs = 7,360 

burden hours) at a cost of $448,960 

($488 estimated cost for each nonaccredited CAH × 920 non-accredited 

CAHs = $448,960 estimated cost). 


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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. Respond- ents Responses 

Burden per 

response 

(hours) 

Total annual bur- den 

(hours) 

Hourly 

labor 

cost of 

reporting 

($) 

Total 

labor 

cost of 

reporting 

($) 

Total capital/mainte- nance 

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 AOA-Accredited) ............ 0938—New .............. 402 402 10 4,020 ** 327,228 0 327,228 

§ 485.625(b) (Non-accredited) ............................ 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 speechlanguage 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, facility-based and 

community-based risk assessment 

utilizing an all-hazards approach. 

Organizations 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 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 × 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 × 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 

would require 27,072 burden hours (12 

burden hours for each organization × 

2,256 organizations = 27,072 burden 

hours) to complete the plan at a cost of 

$1,671,696 ($741 estimated cost for each 

organization × 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 


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§ 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 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 × 2,256 

organizations = 23,550 burden hours) at 

a cost of $1,382,928 ($622 estimated 

cost for each organization × 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 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 × 2,256 organizations 

= 18,048 burden hours) at a cost of 

$1,114,464 ($494 estimated cost for each 

organization × 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 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 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 × 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 × 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 


sroberts on DSK5SPTVN1PROD with PROPOSALS
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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, 

facility-based 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. 

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 × 2,256 organizations 

= 6,768 burden hours) at a cost of 

$417,360 ($183 estimated cost for each 

organization × 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)–(4) ............................................. 0938—New .............. 2,256 2,256 12 27,072 ** 1,671,696 0 1,671,696 

§ 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 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, 


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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 × 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 × 

207 CMHCs = $97,290 estimated cost). 

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. 

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 × 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 × 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-to-date 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 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 × 207 

CMHCs = 2,484 burden hours) at a cost 

of $130,410 ($630 estimated cost for 

each CMHC × 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-to-date 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 

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 


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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. 

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 × 207 CMHCs = 1,656 burden 

hours) at a cost of $85,905 ($415 

estimated cost for each CMHC × 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-to-day 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. 

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 × 207 CMHCs = 2,070 burden 

hours) to comply with this proposed 

requirement at a cost of $85,698 ($414 

estimated cost for each CMHC × 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 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. 

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 


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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 × 207 CMHCs = 

828 burden hours) at a cost of $34,362 

($166 estimated cost for each CMHC × 

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. Respond- ents 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) 

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 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 × 

58 OPOs = 580 burden hours) at a cost 

of $47,676 ($822 estimated cost for each 

OPO × 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. 

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 × 58 

OPOs = 1,276 burden hours) at a cost of 

$102,776 ($1,772 estimated cost for each 


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OPO × 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 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 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 × 58 OPOs = 1,160 burden hours) 

at a cost of $85,956 (estimated cost for 

each OPO of $1,482 × 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, 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. 

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 × 58 

OPOs = 812 burden hours) at a cost of 

$62,524 ($1,078 estimated cost for each 

OPO × 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 


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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 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 × 58 OPOs 

= 2,320 burden hours) at a cost of 

$139,548 ($2,406 estimated cost for each 

OPO × 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). 

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 × 58 OPOs = 290 

burden hours) at a cost of $16,124 ($278 

estimated cost for each OPO × 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 

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 × 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 × 

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 

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 


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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 × 58 OPOs = 754 burden hours) at 

a cost of $56,202 ($969 estimated cost 

for each OPO × 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

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 

(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 

(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 communitybased risk assessment is only 


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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 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 × 4,013 

RHCs = 39,410 burden hours) at a cost 

of $2,857,256 ($712 estimated cost for 

each RHC × 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 × 5,534 FQHCs = 27,670 burden 

hours) at a cost of $1,970,104 ($356 

estimated cost for each FQHC × 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 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 ‘‘allhazards 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 

56,182 burden hours (14 burden hours 

for each RHC × 4,013 RHCs = 56,182 

burden hours) to complete the plan at a 

cost of $3,808,337 ($949 estimated cost 

for each RHC × 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 × 5,534 

FQHCs = 44,272 burden hours) to 

complete the plan at a cost of 

$2,933,020 ($530 estimated cost for each 

FQHC × 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). 

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 


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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 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 × 4,013 RHCs = 48,156 burden 

hours) at a cost of $3,884,584 ($968 

estimated cost for each RHC × 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 × 5,534 FQHCs = 44,272 burden 

hours) at a cost of $3,364,672 ($608 

estimated cost for each FQHC × 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. 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 nonmedical 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 

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 × 4,013 RHCs = 40,130 

burden hours) at a cost of $3,443,154 

($734 estimated cost for each RHC × 

4,013 RHCs = $3,443,154 estimated 

cost). 


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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 × 5,534 FQHCs = 27,670 

burden hours) at a cost of $2,030,978 

($367 estimated cost for each FQHC × 

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 

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 × 

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 × 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 

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 

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 × 

9,547 RHCs/FQHCs = 47,735 burden 

hours) at a cost of $2,634,972 ($276 

estimated cost for each RHC/FQHC × 

9,547 RHC/FQHCs = $2,634,972 

estimated cost). 


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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. Respond- ents 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 ** 2,030,978 0 2,030,978 

§ 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 

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-atrisk; 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 

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 × 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 × 5,923 dialysis facilities = 

$4,963,474 estimated cost). 

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 


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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 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 each dialysis facility × 

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 × 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 manmade 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 

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 × 

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 × 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 (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 


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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 textmessaging 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. 

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 × 5,923 dialysis facilities = 

23,692 burden hours) at a cost of 

$2,114,511 ($357 estimated cost for each 

dialysis facility × 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 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 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 × 

5,923 dialysis facilities = 41,461 burden 

hours) to comply with this requirement 

at a cost of ($559 estimated cost for each 

dialysis facility × 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 paperbased, 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 

man-made 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. 

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 


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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. Respond- ents Responses 

Burden per 

response 

(hours) 

Total annual burden 

(hours) 

Hourly labor cost of reporting ($) 

Total 

labor 

cost of 

reporting 

($) 

Total 

capital/ mintenance 

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. 

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. 

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 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 


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disaster, so we also considered other 

more common disasters. The United 

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. 

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-forprofit 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, 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 

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 Medicaidparticipating 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 


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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 

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 back-up 

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 

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 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) × 

$25.45 an hour =$152.70 

• Fuel: Diesel cost of $3.85 per gallon 

× 72 gallon per hour × 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)) 

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 paperbased, 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 


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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 documentation of all mock 

disaster drills. ASCs also would be 

required to conduct a paper-based, 

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 for all ASCs ($500 × 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 facilitywide 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 × 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). 

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 facilitywide 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 facilitywide 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 total annual 

cost for all PACE organizations is $8,190 

($90 × 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. 


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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 

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 in-hospital 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 preparednesstraining program and the materials they 

plan to use in providing initial and ongoing 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 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 communitywide 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 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 TJCaccredited hospitals to comply with this 

requirement would require 72,864 total 

economic impact hours (48 economic 

impact hours per non TJC-accredited 

hospital × 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 TJCaccredited hospital × 1,518 hospitals = 

$5,100,480). 

Based on TJC’s standards, the TJCaccredited 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. 

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 × $25.45/hr ($152.70) × 869 nonaccredited hospitals). We estimate fuel 

cost to be $963,547 (72 gallon/hr × 

$3.85/gallon × 4 hours ($1,108.80) × 869 


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non-accredited hospitals) for nonaccredited hospitals. Thus for nonaccredited 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 × 

$25.45/hr)/3 ($101.80)) × 4,059 

accredited hospitals). We estimate fuel 

cost to be $3,000,413 (2 (72 gallon/hr × 

$3.85/gallon × 4 hours)/3 ($739.2)) × 

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. 

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. 

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 × $25.45/hr 

($152.70) × 15,157 LTC facilities). We 

estimate fuel cost to be $16,806,082 (72 

gallon/hr × $3.85/gallon × 4 hours 

($1,108.80) × 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 (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-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 


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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. 

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 non-accredited CAHs 

to comply with this requirement, it 

would require 18,400 total economic 

impact hours (20 economic impact 

hours per non-accredited CAH × 920 

non-accredited CAH) at an estimated 

total cost of $1,041,440 ($1,132 × 920). 

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 × 

$25.45/hr ($152.70) × 915 nonaccredited CAHs). We estimate fuel cost 

to be $1,014,552 (72 gallon/hr × $3.85/ 

gallon × 4 hours ($1,108.80) × 915 nonaccredited 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 × 

$25.45/hr)/3 ($101.80)) × 407 accredited 

CAHs). We estimate fuel cost to be 

$300,854 (2 (72 gallon/hr × $3.85/gallon 

× 4 hours)/3 ($739.2)) × 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). 

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 × 207 CMHCs) total 

economic impact hours at a total 

estimated cost of $85,905 ($415 × 207 

CMHCs). Therefore, the total economic 

impact of this rule on CMHCs would be 

$674,820 ($85,905 impact cost + 

$588,915 ICR burden). 


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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 paperbased, 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 × 58 OPOs) total 

economic impact hours at an estimated 

cost of $6,206 ($107 × 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 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 facilitywide 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 facilitywide 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). 

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 × 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. 

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 


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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 

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. 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 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 


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79178 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

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 (AbdelKader K, Unrah ML. Disaster and endstage 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). 

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 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 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 


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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). 

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 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-Issues-Confronting-Hospitals2012.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 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: 

• 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 


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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 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

Category Estimates 

Units 

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 Monetized ($million/year) .............................................................. 86 2013 7% 2014–2018 

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. 

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. 

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. 

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). 


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Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 79181 

§ 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 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 atrisk; 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. 

(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. 

(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). 

(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, clinicallyrelevant 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. 


sroberts on DSK5SPTVN1PROD with PROPOSALS
79182 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

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). 

§ 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 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 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 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, facilitybased 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, clinicallyrelevant emergency scenario, and a set 

of problem statements, directed 

messages, or prepared questions 

designed to challenge 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. 


sroberts on DSK5SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 79183 

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 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 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. 

(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 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 


sroberts on DSK5SPTVN1PROD with PROPOSALS
79184 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

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 group discussion led by a 

facilitator, using a narrated, clinicallyrelevant 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 atrisk; 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. 

(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); 

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. 

(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 


sroberts on DSK5SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 79185 

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. 

(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, facilitybased 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, clinicallyrelevant 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 ALLINCLUSIVE 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: 

§ 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 

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 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. 


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(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: 

(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 manmade emergency that requires activation 

of the emergency plan, the PACE 

organization is exempt from engaging in 

a community or individual, facilitybased 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, clinicallyrelevant 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 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 atrisk; 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. 

(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 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. 


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(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). 

(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, clinicallyrelevant emergency scenario, and a set 

of problem statements, directed 

messages, or prepared questions 

designed to challenge 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 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 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 atrisk; 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 


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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; 

(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 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 

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 group discussion led by a 

facilitator, using a narrated, clinicallyrelevant 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 


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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 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. 

(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. 

(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: 

(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. 

(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. 


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79190 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

(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, clinicallyrelevant emergency scenario, and a set 

of problem statements, directed 

messages, or prepared questions 

designed to challenge an emergency 

plan. 

(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 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. 

(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. 

(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 


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Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 79191 

plan, the HHA is exempt from engaging 

in a community or individual, facilitybased 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, clinicallyrelevant 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: 

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 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: 

(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. 

(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, facilitybased 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, clinicallyrelevant 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. 


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79192 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

§ 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: 

§ 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 atrisk; 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: 

(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. 

(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. 

(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: 

(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, facilitybased 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, clinicallyrelevant emergency scenario, and a set 

of problem statements, directed 

messages, or prepared questions 


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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. 

(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. 

(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. 

(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. 

(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 


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79194 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

exercise is a group discussion led by a 

facilitator, using a narrated, clinicallyrelevant 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. 

■ 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 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 

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. 

(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, clinicallyrelevant 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. 


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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 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. 

(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, clinicallyrelevant 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. 

(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: 

(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 


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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. 

(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). 

(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, clinicallyrelevant emergency scenario, 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: 

(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 


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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. 

(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 

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. 

(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. 

(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, clinicallyrelevant 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. 

(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. 

Editorial Note: This document was 

received in the Office of the Federal Register 

on December 19, 2013. 

Note: The following appendix will not 

appear in the Code of Federal Regulations 


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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 

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, capabilitiesbased 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/presidentialpolicy-directive-8-national-preparedness and 

at http://www.phe.gov/Preparedness/legal/

policies/Pages/ppd8.aspx. 

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/TCR-AL122005_

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 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 

• 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://georgewbush-whitehouse.archives.gov/

homeland/pandemic-influenzaimplementation.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’’ Web site 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’’ 


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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 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 well-prepared 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, 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-riskreport0901.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 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. 

• 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/

TheLawEthicsofDisasterResponse/

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 other federal 

emergency preparedness Web sites and can 

be found at: (http://www.nhha.org/

WhatsNewFiles/S&C-08- 

01.01.AllHazardsFAQsmemo.pdf). In 

addition, the Web site 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 Web 

site 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) 


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79200 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

• Saving Lives: Including People with 

Disabilities in Emergency Planning (2005) 

[FR Doc. 2013–30724 Filed 12–20–13; 4:15 pm] 

BILLING CODE 4120–01–P 


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