[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Proposed Rules]
[Pages 79081-79200]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30724]



[[Page 79081]]

Vol. 78

Friday,

No. 249

December 27, 2013

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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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

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

[[Page 79082]]


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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.

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SUMMARY: This proposed rule would establish national emergency 
preparedness requirements for Medicare- and Medicaid-participating 
providers and suppliers to ensure that they adequately plan for both 
natural and man-made disasters, and coordinate with federal, state, 
tribal, regional, and local emergency preparedness systems. It would 
also ensure that these providers and suppliers are adequately prepared 
to meet the needs of patients, residents, clients, and participants 
during disasters and emergency situations.
    We are proposing emergency preparedness requirements that 17 
provider and supplier types must meet to participate in the Medicare 
and Medicaid programs. Since existing Medicare and Medicaid 
requirements vary across the types of providers and suppliers, we are 
also proposing variations in these requirements. These variations are 
based on existing statutory and regulatory policies and differing needs 
of each provider or supplier type and the individuals to whom they 
provide health care services. Despite these variations, our proposed 
regulations would provide generally consistent emergency preparedness 
requirements, enhance patient safety during emergencies for persons 
served by Medicare- and Medicaid-participating facilities, and 
establish a more coordinated and defined response to natural and man-
made disasters.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on February 25, 
2014.

ADDRESSES: In commenting, please refer to file code CMS-3178-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3178-P, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Mail Stop C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses prior to 
the close of the comment period: a. For delivery in Washington, DC--
Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Room 445-G, Hubert H. Humphrey Building, 200 
Independence Avenue SW., Washington, DC 20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call telephone number (410) 786-7195 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 

Janice Graham, (410) 786-8020.
Mary Collins, (410) 786-3189.
Diane Corning, (410) 786-8486.
Ronisha Davis, (410) 786-6882.
Lisa Parker, (410) 786-4665.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

Acronyms

AAAHC Accreditation Association for Ambulatory Health Care, Inc.
AAAASF American Association for Accreditation for Ambulatory Surgery 
Facilities, Inc.
AAR/IP After Action Report/Improvement Plan
ACHC Accreditation Commission for Health Care, Inc.
ACHE American College of Healthcare Executives
AHA American Hospital Association
AO Accrediting Organization
AOA American Osteopathic Association
ASC Ambulatory Surgical Center
ARCAH Accreditation Requirements for Critical Access Hospitals
ASPR Assistant Secretary for Preparedness and Response
BLS Bureau of Labor Statistics
BTCDP Bioterrorism Training and Curriculum Development Program
CAH Critical Access Hospital
CAMCAH Comprehensive Accreditation Manual for Critical Access 
Hospitals
CAMH Comprehensive Accreditation Manual for Hospitals
CASPER Certification and the Survey Provider Enhanced Reporting
CDC Centers for Disease Control and Prevention
CFC Conditions for Coverage
CHAP Community Health Accreditation Program
CMHC Community Mental Health Center
COI Collection of Information
COP Conditions of Participation
CORF Comprehensive Outpatient Rehabilitation Facilities
CPHP Centers for Public Health Preparedness
CRI Cities Readiness Initiative

[[Page 79083]]

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 (Sec.  
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) (Sec.  403.748)
    C. Emergency Preparedness Regulations for Ambulatory Surgical 
Centers (ASCs) (Sec.  416.54)
    D. Emergency Preparedness Regulations for Hospice (Sec.  
418.113)
    E. Emergency Preparedness Regulations for Inpatient Psychiatric 
Residential Treatment Facilities (PRTFs) (Sec.  441.184)
    F. Emergency Preparedness Regulations for Programs of All-
Inclusive Care for the Elderly (PACE) (Sec.  460.84)
    G. Emergency Preparedness Regulations for Transplant Centers 
(Sec.  482.78)
    H. Emergency Preparedness Regulations for Long-Term Care (LTC) 
Facilities (Sec.  483.73)
    I. Emergency Preparedness Regulations for Intermediate Care 
Facilities for Individuals with Intellectual Disabilities (ICF/IID) 
(Sec.  483.475)
    J. Emergency Preparedness Regulations for Home Health Agencies 
(HHAs) (Sec.  484.22)
    K. Emergency Preparedness Regulations for Comprehensive 
Outpatient Rehabilitation Facilities (CORFs) (Sec.  485.68)
    L. Emergency Preparedness Regulations for Critical Access 
Hospitals (CAHs) (Sec.  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 
(Sec.  485.727)
    N. Emergency Preparedness Regulations for Community Mental 
Health Centers (CMHCs) (Sec.  485.920)
    O. Emergency Preparedness Regulations for Organ Procurement 
Organizations (OPOs) (Sec.  486.360)
    P. Emergency Preparedness Regulations for Rural Health Clinics 
(RHCs) and Federally Qualified Health Centers (FQHCs) (Sec.  491.12)
    Q. Emergency Preparedness Regulations for End-Stage Renal 
Disease (ESRD) Facilities (Sec.  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 (Sec.  403.748)
    D. ICRs Regarding Condition for Coverage: Emergency Preparedness 
(Sec.  416.54)
    E. ICRs Regarding Condition of Participation: Emergency 
Preparedness (Sec.  418.113)
    F. ICRs Regarding Emergency Preparedness (Sec.  441.184)
    G. ICRs Regarding Emergency Preparedness (Sec.  460.84)
    H. ICRs Regarding Condition of Participation: Emergency 
Preparedness (Sec.  482.15)
    I. ICRs Regarding Condition of Participation: Emergency 
Preparedness for Transplant Centers (Sec.  482.78)
    J. ICRs Regarding Emergency Preparedness (Sec.  483.73)
    K. ICRs Regarding Condition of Participation: Emergency 
Preparedness (Sec.  483.475)
    L. ICRs Regarding Condition of Participation: Emergency 
Preparedness (Sec.  484.22)
    M. ICRs Regarding Condition of Participation: Emergency 
Preparedness (Sec.  485.68)
    N. ICRs Regarding Condition of Participation: Emergency 
Preparedness (Sec.  485.625)
    O. ICRs Regarding Condition of Participation: Emergency 
Preparedness (Sec.  485.727)
    P. ICRs Regarding Condition of Participation: Emergency 
Preparedness (Sec.  485.920)
    Q. ICRs Regarding Condition of Participation: Emergency 
Preparedness (Sec.  486.360)
    R. ICRs Regarding Condition of Participation: Emergency 
Preparedness (Sec.  491.12)
    S. ICRs Regarding Condition of Participation: Emergency 
Preparedness (Sec.  494.62)

[[Page 79084]]

    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 (Sec.  416.54(d)(2))
    F. Condition of Participation: Emergency Preparedness for 
Hospices--Testing (Sec.  418.113(d)(2))
    G. Emergency Preparedness for Psychiatric Residential Treatment 
Facilities (PRTFs) Training and Testing (Sec.  441.184(d))
    H. Emergency Preparedness for Program for the All-Inclusive Care 
for the Elderly (PACE) Organizations--Training and Testing (Sec.  
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)-- (Sec.  485.68(d)(2)(i) through 
(iii))
    O. Condition of Participation: Emergency Preparedness for 
Critical Access Hospitals (CAHs)--Testing (Sec.  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 (Sec.  485.727(d)(2)(i) 
Through (iii))
    Q. Condition of Participation: Emergency Preparedness for 
Community Mental Health Centers (CMHCs)--Training and Testing (Sec.  
485.920(d))
    R. Conditions of Participation: Emergency Preparedness for Organ 
Procurement Organizations (OPOs)--Training and Testing (Sec.  
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 (Sec.  
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

[[Page 79085]]

from the past, combined with the proven best practices of the present. 
We recognize that central to this approach is to develop and guide 
emergency preparedness and response within the framework of our 
national health care system. To this end, these proposed regulations 
would also encourage providers and suppliers to coordinate their 
preparedness efforts within their own communities and states as well as 
across state lines, as necessary to achieve their goals. We are 
soliciting comments on whether certain requirements should be 
implemented on a staggered basis.
2. Summary of the Major Provisions
    We are proposing emergency preparedness requirements that will be 
consistent and enforceable for all affected Medicare and Medicaid 
providers and suppliers. This proposed rule addresses the three key 
essentials needed to ensure that health care is available during 
emergencies: safeguarding human resources, ensuring business 
continuity, and protecting physical resources. Current regulations for 
Medicare and Medicaid providers and suppliers do not adequately address 
these key elements.
    Based on our research and consultation with stakeholders, we have 
identified four core elements that are central to an effective and 
comprehensive framework of emergency preparedness requirements for the 
various Medicare and Medicaid participating providers and suppliers. 
The four elements of the emergency preparedness program are as follows:
     Risk assessment and planning: This proposed rule would 
propose that prior to establishing an emergency plan, a risk assessment 
would be performed based on utilizing an ``all-hazards'' approach. An 
all-hazards approach is an integrated approach to emergency 
preparedness planning that focuses on capacities and capabilities that 
are critical to preparedness for a full spectrum of emergencies or 
disasters. This approach is specific to the location of the provider 
and supplier considering the particular types of hazards which may most 
likely occur in their area.
     Policies and procedures: We are proposing that facilities 
be required to develop and implement policies and procedures based on 
the emergency plan and risk assessment.
     Communication plan: This proposed rule would require a 
facility to develop and maintain an emergency preparedness 
communication plan that complies with both federal and state law. 
Patient care must be well-coordinated within the facility, across 
health care providers, and with state and local public health 
departments and emergency systems to protect patient health and safety 
in the event of a disaster.
     Training and testing: We are proposing that a facility 
develop and maintain an emergency preparedness training and testing 
program. A well-organized, effective training program must include 
providing initial training in emergency preparedness policies and 
procedures. We propose that the facility ensure that staff can 
demonstrate knowledge of emergency procedures and provide this training 
at least annually. We would require that facilities conduct drills and 
exercises to test the emergency plan.
    We are seeking public comments on when these CoPs should be 
implemented.

B. Current State of Emergency Preparedness

1. Federal Emergency Preparedness
    In response to the September 11, 2001 terrorist attacks and the 
subsequent national need to refine the nation's strategy to handle 
emergency situations, there have been numerous efforts across federal 
agencies to establish a foundation for development and expansion of 
emergency preparedness systems. The following is a brief overview of 
some emergency preparedness activities at the federal level. Additional 
information is included in the appendix to this proposed rule.
a. Presidential Directives
    Three Presidential Directives HSPD-5, HSPD-21 and PPD-8, require 
agencies to coordinate their emergency preparedness activities with 
each other and across federal, state, local, tribal, and territorial 
governments. Although these directives do not specifically require 
Medicare providers and suppliers to adopt such measures, they have set 
the stage for what we expect from our providers and suppliers in regard 
to their roles in a more unified emergency preparedness system. The 
Homeland Security Presidential Directive (HSPD-5), ``Management of 
Domestic Incidents,'' was issued on February 28, 2003. This directive 
authorizes the Department of Homeland Security to develop and 
administer the National Incident Management System (NIMS). The NIMS 
provides a consistent national template that enables federal, state, 
local, and tribal governments, as well as private-sector and 
nongovernmental organizations, to work together effectively and 
efficiently to prepare for, prevent, respond to, and recover from 
domestic incidents, regardless of cause, size, or complexity, including 
acts of catastrophic terrorism. The Presidential Policy Directive (PPD-
8 focuses on strengthening the security and resilience of the nation 
through systematic preparation for the full range of 21st century 
hazards that threaten the security of the nation, including acts of 
terrorism, cyber attacks, pandemics, and catastrophic natural 
disasters. The directive is founded by 3 key principles which include: 
(1) employ an all-of-nation/whole community approach, integrate efforts 
across federal, state, local, tribal and territorial governments; (2) 
build key capabilities to confront any challenge; and (3) utilize an 
assessment system focused on outcomes to measure and track progress. 
Finally, the Presidential directive published on October 18, 2007, 
entitled, ``Homeland Security Presidential Directive/HSPD-21,'' 
addresses public health and medical preparedness. The directive, found 
at http://www.dhs.gov/xabout/laws/gc_1219263961449.shtm, establishes a 
National Strategy for Public Health and Medical Preparedness 
(Strategy), which aims to transform our national approach to protecting 
the health of the American people against all disasters. HSPD-21 
summarizes implementation actions that are the four most critical 
components of public health and medical preparedness: biosurveillance, 
countermeasure stockpiling and distribution, mass casualty care, and 
community resilience. The directive states that these components will 
receive the highest priority in public health and medical preparedness 
efforts.
b. Assistant Secretary for Preparedness and Response
    In December 2006, the President signed the Pandemic and All-Hazards 
Preparedness Act (PAHPA) (Pub. L. 109-417). The purpose of the Pandemic 
and All-Hazards Preparedness Act is ``to improve the Nation's public 
health and medical preparedness and response capabilities for 
emergencies, whether deliberate, accidental, or natural.'' The Office 
of the Assistant Secretary for Preparedness and Response (ASPR) was 
created under the PAHPA Act in the wake of Katrina to lead the nation 
in preventing, preparing for, and responding to the adverse health 
effects of public health emergencies and disasters. The Secretary of 
HHS delegates to ASPR the leadership role for all health and medical 
services support functions in a health emergency or public health 
event. ASPR also serves as the senior advisor to the HHS

[[Page 79086]]

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.

[[Page 79087]]

Government H1N1, Avian, and Pandemic Flu Information'' at www.flu.gov. 
The Web site provides links to influenza guidance and information from 
federal agencies, such as the CDC, as well as checklists for pandemic 
preparedness. The information and links are found at http://www.flu.gov/professional/index.html. This Web site includes information 
for hospitals, long term care facilities, outpatient facilities, home 
health agencies, other health care providers, and clinicians. For 
example, the ``Hospital Pandemic Influenza Planning Checklist'' 
provides guidance on structure for planning and decision making; 
development of a written pandemic influenza plan; and elements of an 
influenza pandemic plan. The checklist is comprehensive and lists 
everything a hospital should do to prepare for a pandemic, from 
planning for coordination with local and regional planning and response 
groups to infection control.
2. State and Local Preparedness
    A review of studies and articles regarding readiness of state and 
local jurisdictions reveals that there is inconsistency in the level of 
emergency preparedness amongst states and need for improvement in 
certain areas. In a report by the Trust for America's Health (TFAH) 
(December 2012, http://www.healthyamericans.org/report/101/) entitled, 
``Ready or Not? Protecting the Public's Health from Diseases, 
Disasters, and Bioterrorism'' the authors assessed state-by-state 
public health preparedness nearly 10 years after the September 11th and 
anthrax tragedies. Using 10 key indicators to rate levels of public 
health preparedness, some key findings included: (1) 29 states cut 
public health funding from fiscal years (FY) 2010 through 2012, with 2 
of these states cutting funds for a second year in a row and 14 for 3 
consecutive years, and that federal funds for state and local 
preparedness have decreased by 38 percent from FY 2005 through 2012 and 
(2) 35 states and Washington DC do not currently have complete climate 
change adaption plans, which include planning for health threats posed 
by extreme weather events.
    An article entitled, ``Public Health Response to Urgent Case 
Reports,'' published in Health Affairs (August 30, 2005), Dausey, D., 
Lurie, N., and Diamond, A.) evaluated the ability of local public 
health agencies (LPHAs) to adequately meet ``a preparedness standard'' 
set by the CDC. The standard was for the LPHAs ``to receive and respond 
to urgent case reports of communicable diseases 24 hours a day, 7 days 
a week.'' Using 18 metropolitan area LPHAs that were roughly evenly 
distributed by agency size, structure, and region of the country, the 
goal of the test was to contact an ``action officer'' (that is, 
physician, nurse, epidemiologist, bioterrorism coordinator, or 
infection control practitioner) responsible for responding to urgent 
case reports.
    During a 4-month period of time, each LPHA was contacted several 
times and asked questions regarding triage procedures, what questions 
would be asked in the event of an urgent case being filed, next steps 
taken after receiving such a report, and who would be contacted. 
Although the LPHAs had a substantial role in community public health 
through prevention and treatment efforts, the authors found significant 
variation in performance and the systems in place to respond to such 
reports.
    We also reviewed an article published in June 2004 by Lurie, N., 
Wasserman, J., Stoto, M., Myers, S., Namkung, P., Fielding, J., and 
Valdez, R. B., entitled, ``Local Variations in Public Health 
Preparedness: Lessons from California'' found at http://content.healthaffairs.org/cgi/content/full/hlthaff.w4.341/DC1. The 
authors stated that ``evidence-based measures to assess public health 
preparedness are lacking in California.'' Using an ``expert-panel 
process,'' the researchers developed performance measures based on ten 
identified essential public health services. They performed site visits 
and tabletop exercises to evaluate preparedness across the state in 
geographic locations identified as urban, rural, and border status to 
detect and respond to a hypothetical smallpox outbreak based on the 
different measures of preparedness. Overall, the researchers found that 
there was a lack of consensus regarding what ``emergency preparedness'' 
encompassed and a wide variation in what various governmental agencies 
deemed to be adequate emergency preparedness ``readiness'' in 
California. They noted that gaps in the infrastructure were common.
    Throughout the jurisdictions investigated, there were similarities 
noted in the shortage of nurses, the number of essential workers 
nearing retirement age, and the lack of epidemiologists, lab personnel, 
and public health nurses to meet potential needs. Such gaps in 
personnel infrastructure were found in many jurisdictions. In some 
jurisdictions, there was incomplete information regarding the 
demographics of persons who could be considered potentially vulnerable 
or part of an underserved population.
    In one situation, there was also great variability in the length of 
time it took to bring three suspicious cases to public health officers' 
attention and for these officers to realize that these cases were 
related. There was great variation in the public health officers' 
ability to rapidly alert the physician and hospital community of an 
outbreak. There was a lack of consensus regarding when to report a 
potential outbreak to the public. There also was wide variation in 
knowledge of public health legal authority, specifically, in regard to 
quarantine and its enforcement. We believe these findings to be typical 
of most states.
3. Hospital Preparedness
    Hospitals are the focal points for health care in their respective 
communities; thus, it is essential that hospitals have the capacity to 
respond in a timely and appropriate manner in the event of a natural or 
man-made disaster. Additionally, since Medicare-participating hospitals 
are required to evaluate and stabilize every patient seen in the 
emergency department and to evaluate every inpatient at discharge to 
determine his or her needs and to arrange for post-discharge care as 
needed, hospitals are in the best position to coordinate emergency 
preparedness planning with other providers and suppliers in their 
communities. We would expect hospitals to be prepared to provide care 
to the greatest number of disaster victims for which they have the 
capacity, while meeting at least minimal obligations for care to all 
who are in need.
    In 2007, ASPR contracted with the Center for Biosecurity of the 
University of Pittsburgh Medical Center (UPMC) (the Center) to conduct 
an assessment of U.S. hospital preparedness and to develop 
recommendations for evaluating and improving future hospital 
preparedness efforts. The Center's assessment, entitled ``Hospitals 
Rising to the Challenge: The First Five Years of the U.S. Hospital 
Preparedness Program and Priorities Going Forward'' describes the most 
important components of preparedness for mass casualty response at the 
local and regional hospital and healthcare system levels. This 
evaluation report was based on extensive analyses of the published 
literature, government reports, and HPP program assessments, as well as 
on detailed conversations with 133 health officials and hospital 
professionals representing every state, the largest cities, and major 
territories of the U.S.

[[Page 79088]]

    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.

[[Page 79089]]

    The GAO found that ``hospital and nursing home administrators are 
often responsible for deciding whether to evacuate patients from their 
facilities due to disasters, including hurricanes or other natural 
disasters. State and local governments can order evacuations of the 
population or segments of the population during emergencies, but health 
care facilities may be exempt from these orders.'' The GAO found that 
hospitals and nursing home administrators evacuate only as a last 
resort and that these facilities' emergency plans are designed 
primarily to shelter in place. The GAO also found that administrators 
considered the availability of adequate resources to shelter in place, 
the risks to patients in deciding when to evacuate, the availability of 
transportation to move patients, the availability of receiving 
facilities to accept patients, and the destruction of the facility's or 
community's infrastructure.
    The GAO noted that nursing home administrators also must consider 
the fact that nursing home residents cannot care for themselves and 
generally have no home and no place to live other than the nursing 
home. Therefore, in the event of an evacuation, nursing homes also need 
to consider the necessity of locating facilities that can accommodate 
their residents for a long period of time.
    A second report from the GAO about the hurricanes' impact entitled, 
``Disaster Preparedness: Limitations in Federal Evacuation Assistance 
for Health Facilities Should be Addressed,'' (GAO-06-826) July, 2006, 
www.gao.gov/cgi-bin/getrpt?GAO-06-826), supports the findings noted in 
the first GAO report on the disasters. In addition, the GAO noted that 
the evacuation issues that facilities faced during and after the 
hurricanes occurred due to their inability to secure transportation 
when needed. Despite previously established contracts with 
transportation companies, demand for this assistance overwhelmed the 
supply of vehicles in the community.
    A third report, an after-event analysis entitled, ``Hurricane 
Katrina: Status of Hospital Inpatient and Emergency Departments in the 
Greater New Orleans Area,'' (GAO-06-1003) September 29, 2006, http://www.gao.gov/docdblite/details.php?rptno=GAO-06-1003) revealed that, as 
of April 2006: (1) Emergency departments were experiencing 
overcrowding; but that (2) the number of staffed inpatient beds per 
1,000 population was greater than that of the national average and 
expected to increase further. However, the study found that the number 
of staffed inpatient beds was not available in psychiatric care 
settings. In fact, some persons with mental health needs had to be 
transferred out of the area due to a lack of beds. Attracting and 
retaining nursing and support staff were two problems that were 
identified as hindering efforts to maintain an adequate supply of 
staffed beds for psychiatric patients.
    While this study focused specifically on patient care issues in the 
New Orleans area, the same issues are common to hospitals in any major 
metropolitan area. Given the vulnerability of persons with mental 
illness and the tremendous stress a man-made or natural disaster can 
put on the entire general population, an increase in the number of 
persons who seek mental health services and require inpatient 
psychiatric care can be expected following any natural or man-made 
disaster.
    In another report from the GAO, an after-event analysis entitled, 
``Disaster Recovery: Past Experiences Offer Recovery Lessons for 
Hurricane Ike and Gustav and Future Disasters,'' (GAO-09-437T March 3, 
2009, http://www.gao.gov/products/GAO-09-437T) the GAO concluded that 
recovery from major disasters is a complex undertaking that involves 
the combined efforts of federal, state, and local government in order 
to succeed. The GAO stated that while the federal government provides a 
significant amount of financial and technical assistance for recovery, 
state and local jurisdictions should work closely with federal agencies 
to secure and make use of those resources.
    In a report from the GAO, entitled, ``Influenza Pandemic: Gaps in 
Pandemic Planning and Preparedness Need to be Addressed,'' (GAO-09-909T 
July 29, 2009; http://www.gao.gov/new.items/d09909t.pdf), the GAO 
expressed its concern that, despite a number of actions having been 
taken to plan for a pandemic, including developing a National Strategy 
and Implementation Plan, many gaps in pandemic planning and 
preparedness still existed in the presence of a potential pandemic 
influenza outbreak.
    In November 2009, the GAO published an additional report entitled, 
``Influenza Pandemic: Monitoring and Assessing the Status of the 
National Pandemic Implementation Plan Needs Improvement,'' (GAO-10-73) 
(http://www.gao.gov/new.items/d1073.pdf). In this report, the GAO 
assessed the progress of the responsible federal agencies (including 
HHS) in implementing the action items set forth in the ``National 
Strategy for Pandemic Influenza: Implementation Plan'' (the Plan) 
(http://georgewbush-whitehouse.archives.gov/homeland/pandemic-influenza-implementation.html). Specifically, the researchers were 
interested in determining how the Homeland Security Council (HSC) and 
the responsible federal agencies were monitoring the progress and 
completion of the Plan's 342 action items, and assessing the extent to 
which selected action items were completed, whether activity had 
continued on the selected action items reported as complete, and the 
nature of that work. Having conducted an in-depth analysis of a random 
sample of 60 action items, the GAO found the status of selected action 
items considered complete was difficult to determine. Specifically, the 
GAO found that: (1) Measures of performance used to determine status 
did not always fully reflect the descriptions of the action items; (2) 
some selected action items were designated as complete despite 
requiring actions outside the authority of the responsible entities; 
and (3) additional work was conducted on some selected action items 
designated as complete. Ultimately, the GAO recommended that, in order 
to improve how progress is monitored and completion is assessed under 
the Plan and subsequent updates of the Plan, the HSC should instruct 
the White House National Security Staff (NSS) to work with responsible 
federal agencies to: (1) Develop a monitoring and reporting process for 
action items that are intended for nonfederal entities, such as state 
and local governments; (2) identify the types of information needed to 
decide whether to carry out the response-related action items; and (3) 
develop measures of performance that are more consistent with the 
descriptions of the action items.

C. Statutory and Regulatory Background

    Various sections of the Social Security Act (the Act) define the 
terms Medicare uses for each provider and supplier type and list the 
requirements that each provider and supplier must meet to be eligible 
for Medicare and Medicaid participation. Each statutory provision also 
specifies that the Secretary may establish other requirements as the 
Secretary finds necessary in the interest of the health and safety of 
patients, although the exact wording of such authority may differ 
slightly between different provider and supplier types. These 
requirements are called the Conditions of Participation (CoPs) for 
providers and the Conditions for Coverage (CfCs) for suppliers. The 
CoPs and CfCs are intended to protect public health and safety and 
ensure that high

[[Page 79090]]

quality care is provided to all persons. Further, the Public Health 
Service (PHS) Act sets forth additional requirements that certain 
Medicare providers and suppliers must meet to participate.
    The following are the statutory and regulatory citations for the 
providers and suppliers for which we intend to propose emergency 
preparedness regulations:
     Religious Nonmedical Health Care Institutions (RNHCIs)--
section 1821 of the Act and 42 CFR 403.700 through 403.756.
     Ambulatory Surgical Centers (ASCs)--section 
1832(a)(2)(F)(i) of the Act and 42 CFR 416.40 through 416.49.
     Hospices--section 1861(dd)(1) of the Act and 42 CFR 418.52 
through 418.116.
     Inpatient Psychiatric Services for Individuals Under Age 
21 in Psychiatric Facilities or Programs (PRTFs)--sections 1905(a) and 
1905(h) of the Act and 42 CFR 441.150 through 441.182 and 42 CFR 
483.350 through 483.376.
     Programs of All-Inclusive Care for the Elderly (PACE)--
sections 1894, 1905(a), and 1934 of the Act and 42 CFR 460.2 through 
460.210.
     Hospitals--section 1861(e)(9) of the Act and 42 CFR 482.1 
through 482.66.
     Transplant Centers--sections 1861(e)(9) and 1881(b)(1) of 
the Act and 42 CFR 482.68 through 482.104.
     Long Term Care (LTC) Facilities -Skilled Nursing 
Facilities (SNFs) -under section 1819 of the Act, Nursing Facilities 
(NFs)--under section 1919 of the Act, and 42 CFR 483.1 through 483.180.
     Intermediate Care Facilities for Individuals with 
Intellectual Disabilities (ICF/IID)--section 1905(d) of the Act and 42 
CFR 483.400 through 483.480.
     Home Health Agencies (HHAs)--sections 1861(o), 1891 of the 
Act and 42 CFR 484.1 through 484.55.
     Comprehensive Outpatient Rehabilitation Facilities 
(CORFs)--section 1861(cc)(2) of the Act and 42 CFR 485.50 through 
485.74.
     Critical Access Hospitals (CAHs)--sections 1820 and 
1861(mm) of the Act and 42 CFR 485.601 through 485.647.
     Clinics, Rehabilitation Agencies, and Public Health 
Agencies as Providers of Outpatient Physical Therapy and Speech-
Language Pathology Services--section 1861(p) of the Act and 42 CFR 
485.701 through 485.729.
     Community Mental Health Centers (CMHCs)--section 
1861(ff)(3)(B)(i)(ii) of the Act, section 1913(c)(1) of the PHS Act, 
and 42 CFR 410.110.
     Organ Procurement Organizations (OPOs)--section 1138 of 
the Act and section 371 of the PHS Act and 42 CFR 486.301 through 
486.348.
     Rural Health Clinics (RHCs)--section 1861(aa) of the Act 
and 42 CFR 491.1 through 491.11; Federally Qualified Health Centers 
(FQHCs)--section 1861(aa) of the Act and 42 CFR 491.1 through 491.11, 
except 491.3.
     End-Stage Renal Disease (ESRD) Facilities--sections 
1881(b), 1881(c), 1881(f)(7) of the Act and 42 CFR 494.1 through 
494.180.
    We considered proposing these regulations for each provider and 
supplier type individually, as we updated their CoPs or CfCs over time. 
However, for the reasons we have already discussed, we believe the most 
prudent course of action is to publish emergency preparedness 
requirements for Medicare and Medicaid providers and suppliers in a 
single proposed rule. Thus, we are proposing regulatory language for 17 
Medicare and Medicaid providers and suppliers to address the four main 
aspects of emergency preparedness: (1) Risk assessment and planning; 
(2) policies and procedures; (3) communication; and (4) training.

II. Provisions of the Proposed Regulations

    This proposed rule responds to concerns from the Congress, the 
health care community, and the public regarding the ability of health 
care providers and suppliers to plan and execute appropriate emergency 
response procedures for disasters. We developed this proposed rule 
taking into consideration the extent of regulatory oversight that is 
currently in existence.
    We are proposing requirements for facilities to ensure the 
continued provision of necessary care at the facility or, if needed, 
the evacuation and transfer of patients to a location that can supply 
necessary care. Regulations that address these functions too 
specifically may become outdated over time as technology and the nature 
of threats change. However, as our analysis of existing regulations, 
and the OIG and GAO reports discussed in section I. of this proposed 
rule, indicate regulations that are too broad may be ineffective. Our 
challenge is to develop core components that can be used across 
provider and supplier types as diverse as hospitals, organ procurement 
organizations, and home health agencies, while tailoring requirements 
for individual provider and supplier types to their specific needs and 
circumstances, as well as the needs of their patients, residents, 
clients, and participants.
    We have identified four core elements that we believe are central 
to an effective emergency preparedness system and must be addressed to 
offer a more comprehensive framework of emergency preparedness 
requirements for the various Medicare- and Medicaid-participating 
providers and suppliers. The four elements are--(1) risk assessment and 
planning; (2) policies and procedures; (3) communication; and (4) 
training and testing. We have also proposed an additional requirement 
for OPOs entitled ``Agreements with other OPOs and hospitals.''
    We believe many of the proposed elements of an emergency 
preparedness plan need to be conducted at the level of an individual 
facility. However, other elements may be addressed as effectively, and 
more efficiently, at a broader organizational level, for example, a 
system for preserving medical documentation. Our regulatory 
requirements for each provider and supplier type are based on the 
comprehensive emergency preparedness requirements that we are proposing 
for hospitals. Since we are aware that the application of the proposed 
regulatory language for hospitals may be inappropriate or overly 
burdensome for some providers and suppliers, we have used the proposed 
hospital requirements as a template for our proposed emergency 
preparedness regulations for other providers and suppliers but have 
specific proposed requirements tailored to each providers' and 
suppliers' unique needs. Any contracted services furnished to patients 
must be in compliance with all the facilities' CoPs and standards of 
this rule, and all services must be provided in a safe and effective 
manner.
    All providers and suppliers would be required to establish an 
emergency preparedness plan that addressed the four core elements noted 
previously. The proposed requirements vary based on the type of 
provider. We discuss the hospital requirements in detail at the 
beginning of this section. The subsequent discussion of the proposed 
requirements for all remaining providers and suppliers focuses on how 
the requirements differ from those proposed for hospitals and why.
    For example, because they are inpatient facilities, religious 
nonmedical health care institutions (RNHCIs), psychiatric residential 
treatment facilities (PRTFs), skilled nursing facilities and nursing 
homes (referred to in this document as long term care (LTC) 
facilities), intermediate care facilities individuals with intellectual 
disabilities (ICFs/IID), and critical access hospitals (CAHs) may have 
greater responsibility than outpatient facilities during an emergency 
for ensuring the health and safety of persons for whom they provide 
care,

[[Page 79091]]

their employees, and volunteers. Thus, proposed requirements for 
RNHCIs, PRTFs, ICFs/IID, LTC facilities, and CAHs are similar to those 
proposed for hospitals.
    In the event of a natural or man-made disaster, providers and 
suppliers of outpatient services, such as ambulatory surgical centers 
(ASCs), programs of all-inclusive care for the elderly (PACE) 
organizations, home health agencies (HHAs), comprehensive outpatient 
rehabilitation facilities (CORFs), rural health clinics (RHCs), 
federally qualified health centers (FQHCs), and end stage renal disease 
(ESRD) facilities, may not open their facilities or may close them, 
sending patients and staff home or to a place where they can safely 
shelter in place. However, we recognize that outpatient facilities may 
find it necessary to shelter their patients until they can be evacuated 
or may be called upon to provide some level of care for community 
residents in the event of an emergency. For example, a CORF that is 
housed in a large building may open its doors to persons in the 
community who would otherwise have no place to go. The CORF may provide 
only shelter from the elements or may provide water, food, and basic 
self-care items, if available.
    Finally, given that some hospice facilities provide both inpatient 
and home based services, and that transplant centers and OPOs are 
unique in their provision of health care, our proposed requirements are 
tailored even more specifically to address the circumstances of these 
entities. We believe lessons learned following the 2005 hurricanes and 
subsequent disasters, such as the flooding in the Midwest in 2008, and 
the tornadoes and flooding in 2011 and 2012, have provided us with an 
opportunity to work collaboratively with the health care community to 
ensure best practices in emergency preparedness across providers and 
suppliers.
    It is important to point out that we expect that implementation of 
certain requirements that we propose for providers and suppliers would 
be different, based on the category of the provider or supplier. For 
example, we propose that nearly all providers and suppliers would be 
required to have policies and procedures to provide subsistence needs 
to staff and patients during an emergency. However, a small RHC's 
implementation of this requirement would be quite different from a 
large metropolitan hospital's implementation. Specifically, with 
respect the proposed requirement that hospitals, CAHs, inpatient 
hospice facilities, PRTFs, LTC facilities, ICFs/IID, and RNHCIs would 
be required to maintain various subsistence needs, we are requesting 
public comment regarding whether this should be a requirement and in 
what quantities and for what time period these subsistence needs would 
be maintained. Nevertheless, we expect that each facility would 
determine how to implement a requirement considering similar variables 
such as whether the provider might have the option of notifying staff 
and patients not to come to the facility due to an emergency; the 
number of staff and patients likely to be in the facility at the time 
of an emergency; whether the provider would have the capability of 
providing shelter, provisions, and health care to members of the 
community; and the amount of space within the facility available for 
storing provisions. Although various providers and suppliers utilize 
different nomenclature to describe the individuals for whom they 
provide care (patient, resident, client, or participant), unless 
otherwise indicated, we will use the term ``patients'' to refer to the 
individuals for whom the provider or supplier under discussion provides 
care.
    Data regarding the number of providers cited in this proposed rule 
were obtained from a variety of different CMS databases. The number of 
providers and suppliers deemed by accrediting organizations to meet the 
Medicare conditions of participation are from CMS's second quarter 
fiscal year 2010 Accrediting Organization System for Storing User 
Recorded Experiences (ASSURE) database. Currently, there are 
accrediting organizations with Medicare deeming authority for 
hospitals, critical access hospitals, HHAs, hospices, and ASCs.
    Data for CAHs that report having psychiatric and rehabilitation 
Distinct Part Units (DPUs) are from the Medicare Quality Improvement 
and Evaluation System (QIES)/Certification and the Survey Provider 
Enhanced Reporting (CASPER) system as of March 2013. Data for CAHs that 
do not have DPUs are from the Online Survey, Certification, and 
Reporting (OSCAR) data system as of March 2013. Data for the number of 
transplant centers are from the CMS Web site as of March 2013. Data for 
the total number of accredited and non-accredited hospitals, HHAs, 
ASCs, hospices, RHNCHIs, PRTFs, SNFs, ICFs/IID, CORFs, OPOs, and RHCs/
FQHCs are from the OSCAR data system as of March 2013. We acquired the 
PACE data from CMS's Health Plan Management System (HPMS), which 
reports the number of PACE contracts. Given that PACE organizations may 
have more than one ``center,'' we are using the number of PACE 
contracts as a reflection of the number of PACE centers under contract 
with the CMS.
    Note that the CMS OSCAR data system is updated periodically by the 
individual states. Due to variations in the timeliness of the data 
submissions, all numbers are approximate, and the number of accredited 
and non-accredited facilities shown may not equal the total number of 
facilities.
    Discussion of the proposed regulatory provisions for each type of 
provider and supplier follows the discussion in this section of the 
hospital requirements in the order in which they would appear in the 
Code of Federal Regulations (CFR). However, our discussion of the 
hospital requirements includes a general discussion of the differences 
between our proposed requirements, based on whether providers and 
suppliers provide outpatient services or inpatient services or both. 
Thus, we encourage all providers to read the discussion of the proposed 
hospital emergency preparedness requirements in section II.A. of this 
proposed rule.
    This section also provides detailed discussion of each proposed 
hospital requirement, offers resources that providers and suppliers can 
use to meet these proposed requirements, offers a means to establish 
and maintain emergency preparedness for their facilities, and provides 
links to guidance materials and toolkits that can be used to help meet 
these requirements.

A. Emergency Preparedness Regulations for Hospitals (Sec.  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 Sec.  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 Sec.  482.1 through Sec.  482.66.

[[Page 79092]]

    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 Sec.  
485.625.
    Services provided by hospitals encompass inpatient and outpatient 
care for persons with various acute or chronic medical or psychiatric 
conditions, including patient care services provided in the emergency 
department. Hospitals are the focal points for health care in their 
respective communities; thus, it is essential that hospitals have the 
capacity to respond in a timely and appropriate manner in the event of 
a natural or man-made disaster. Additionally, since Medicare-
participating hospitals are required to evaluate and stabilize every 
patient seen in the emergency department and to evaluate every 
inpatient at discharge to determine his or her needs and to arrange for 
post-discharge care as needed, hospitals are in the best position to 
coordinate emergency preparedness planning with other providers and 
suppliers in their communities.
    We are proposing a new requirement under 42 CFR 482.15 that would 
require that hospitals have both an emergency preparedness program and 
an emergency preparedness plan. Conceptually, an emergency preparedness 
program encompasses an approach to emergency preparedness that allows 
for continuous building of a comprehensive system of health care 
response to a natural or man-made emergency. We are also proposing that 
a hospital, and all other providers and suppliers, utilize an ``all-
hazards'' approach in the preparation and delivery of emergency 
preparedness services in order to meet the health and safety needs of 
its patient population. The definition of ``all hazards'' is discussed 
later in this section under ``Emergency Plan.''
    We would expect that during an emergency, injured and ill 
individuals would seek health care services at a hospital or CAH, 
rather than from another provider or supplier. For example, during a 
pandemic, individuals with influenza-like symptoms are more likely to 
visit a hospital or CAH emergency department than an ASC. Typically, in 
the event of a chemical spill, affected individuals would not expect to 
receive emergency health care services at an LTC facility but would 
seek health care services at the hospital or CAH in their community. 
However, we believe it is imperative that each provider think in 
broader terms than their own facility, and plan for how they would 
serve similar and other healthcare facilities, as well as the whole 
community during and surrounding an emergency event. We believe the 
first step in emergency management is to develop an emergency plan. An 
emergency plan sets forth the actions for emergency response based on a 
risk assessment that addresses an ``all-hazards approach'' to medical 
and non-medical emergency events. In keeping with the emergency 
management industry and with strong recommendation from the 
Department's Assistant Secretary for Preparedness and Response (ASPR), 
we are proposing that all providers utilize an all-hazards approach to 
emergency response. We do not specify the quantity or the expected 
level of detail in which each hazard would be addressed by each 
provider; however, we do believe it would encourage the adoption of a 
well thought out, cohesive system of response both within and across 
provider types.
    Analysis of anticipated outcomes to the facility-based and 
community-based risk assessments would drive revision to the emergency 
preparedness program, the plan for response, or both. A facility-based 
risk assessment is contained within the actual facility and carried out 
by the facility. A community based risk assessment is carried out 
outside the organization within their defined community.
1. Emergency Plan
a. Emergency Planning Resources
    To stimulate and foster improved emergency preparedness continuity 
of operations, the federal interagency community has developed fifteen 
all-hazards planning scenarios, entitled the ``National Planning 
Scenarios'' for use in federal, state, and local homeland security 
preparedness activities. These scenarios serve as planning tools for 
response to the range of man-made and natural disasters the nation 
could face. The scenarios are: nuclear detonation-improvised nuclear 
device; biological attack--aerosol anthrax; biological disease 
outbreak--pandemic influenza; biological attack--plague; chemical 
attack--blister agent; chemical attack--toxic industrial chemicals; 
chemical attack--nerve agent; chemical attack--chlorine tank explosion; 
natural disaster--major earthquake; and natural disaster--major 
hurricane; radiological attack--radiological dispersal devices; 
explosive attack--bombing using improvised explosive device; biological 
attack--food contamination; biological attack--foreign animal disease 
(foot and mouth disease); and cyber attack. Additional scenarios 
include volcano preparedness and severe winter weather (snow/ice). 
Additional information regarding the National Planning Scenarios and 
how they align to the National Preparedness Goal can be found at: 
http://www.fema.gov/preparedness-1/learn-about-presidential-policy-directive-8#MajorElements.
    These planning tools along with other emergency management and 
business continuity information can be found on HRSA's Web site at: 
http://www.hrsa.gov/emergency/ and also in HRSA's, Policy Information 
Notice entitled, ``Health Center Emergency Management Program 
Expectations,'' (No. 2007-15), dated August 22, 2007, at: http://bphc.hrsa.gov/policiesregulations/policies/pin200715expectations.html). 
While these materials were developed for health centers, the content is 
relevant to all health providers. According to the notice emergency 
management planning is to ensure predictable staff behavior during a 
crisis, provide specific guidelines and procedures to follow and define 
specific roles. Also, emergency planning should address the four phases 
of emergency management that include: mitigation activities to lessen 
the severity and impact a potential disaster or emergency might have on 
a health center's operation; preparedness activities to build capacity 
and identify resources that may be used should a disaster or emergency 
occur; response to the actual emergency and controls the negative 
effects of emergency situations; and recovery that begin almost 
concurrently with response activities and are directed at restoring 
essential services and resuming normal operations to sustain the long-
term viability of the health center. HRSA further states that for 
FQHCs, this means protecting staff and patients, as well as 
safeguarding the facility's ability to deliver health care. According 
to HRSA, the expectations outlined in their guidance are intended to be 
broad to ensure applicability to the diverse range of centers and to 
aid integration of the guidance into what centers already are doing 
related to emergency and risk management. While this guidance is 
targeted toward centers, we believe hospitals and all other providers 
and suppliers can use this guidance in the

[[Page 79093]]

development of their emergency preparedness plans.
    The Agency for Healthcare Research and Quality (AHRQ) released a 
web-based interactive tool entitled, ``Surge Tool Kit and Facility 
Checklist'' (located at: http://www.cdc.gov/phpr/healthcare/documents/shuttools.pdf or at: http://archive.ahrq.gov/research/shuttered/toolkitchecklist/), which will allow hospitals and emergency planners 
to estimate the resources needed to treat a surge of patients resulting 
from a major disaster, such as an influenza pandemic or a terrorist 
attack. Designed to dovetail with the Homeland Security Council's 15 
all-hazards National Planning Scenarios, previously discussed, the AHRQ 
Hospital Surge Model allows users to select a disaster scenario and 
estimate the number of patients needing medical attention by arrival 
condition and day; the number of casualties in the hospital by unit and 
day; and the cumulative number of both dead or discharged casualties by 
day. The tool also calculates the level of hospital resources, 
including personnel, equipment and supplies, needed to treat patients. 
The model estimates resources for biological, chemical, nuclear or 
radiological attacks. (For the development of emergency preparedness 
plans, providers and suppliers may also find the National Fire 
Protection Association's (NFPA) NFPA 1600: ``Standard on Disaster/
Emergency Management and Business Continuity Programs, 2013 Edition,'' 
particularly helpful. The NFPA document can be found at: http://www.nfpa.org/aboutthecodes/AboutTheCodes.asp?DocNum=1600. The standard 
sets forth the basic criteria for a comprehensive program that 
addresses disaster recovery, emergency management, and business 
continuity. Under most definitions, the NFPA 1600 is an industry 
standard for disaster management.
    Also of concern when developing an emergency plan is the issue of 
the allocation of scarce resources during a potentially devastating 
event. Disasters can create situations where such resources must be 
distributed in a manner that is different from usual circumstances, but 
still appropriate to the situation. As discussed in ``Providing Mass 
Medical Care with Scarce Resources: A Community Planning Guide, 
Publication No. 07-0001, Rockville, MD: Agency for Healthcare Research 
and Quality,'' (found at: http://archive.ahrq.gov/research/mce/), such 
resource considerations are part of the impact that natural or man-made 
disasters have on hospitals. This guide provides information on the 
circumstances that communities would likely face as a result of a mass 
casualty event (MCE); key constructs, principles, and structures to be 
incorporated into the planning for an MCE; approaches and strategies 
that could be used to provide the most appropriate standards of care 
possible under the circumstances; examples of tools and resources 
available to help states and communities in their planning processes; 
and illustrative examples of how some health systems, communities, or 
states have approached certain issues as part of their MCE-related 
planning efforts. Building on the work from 2008, the Institute of 
Medicine (IOM) released in 2012 a guidance report entitled ``The Crisis 
Standards of Care (CSC): A Systems Framework for Catastrophic Disaster 
Response'' available at: http://www.iom.edu/Reports/2012/Crisis-Standards-of-Care-A-Systems-Framework-for-Catastrophic-Disaster-Response.aspx. The guidance report expanding upon prior scarce 
resources reports and defined crisis standards of care as ``the optimal 
level of health care that can be delivered during a catastrophic event, 
requiring a substantial change in usual health care operations.'' The 
report stated that CSC; provides a mechanism for responding to 
situations in which the demand on needed resources far exceeds the 
resource availability (that is, scarce resources); implementation of 
CSC involves a substantial shift in normal health care activities and 
reallocation of staff, facilities, and resources; and that to 
transition quickly and effectively, each organization and agency has a 
responsibility to plan and identify in advance the core functions it 
must carry out in a crisis and who will be responsible for each task.
    Another resource that would be useful in helping planners address 
the issues associated with preparing for and responding to an MCE in 
the context of broader emergency planning processes is the document 
entitled, ``Standing Together: An Emergency Planning Guide for 
America's Communities'' (published by The Joint Commission (TJC), 
formerly known as the Joint Commission on the Accreditation of 
Healthcare Organizations, 2006). The document by TJC is a comprehensive 
resource that offers step-by-step guidance for development of an 
emergency preparedness plan that is applicable to small, rural, and 
suburban communities. This document can be found at: http://www.jointcommission.org/Standing_Together__An_Emergency_Planning_Guide_for_Americas_Communities/. This document may be particularly 
useful for small or rural facilities and agencies.
    Rural communities face challenges in the delivery of health care 
that are often very different from those faced by urban and suburban 
communities. While rural communities depend on public health 
departments, hospitals, and emergency medical services (EMS) providers 
just as urban and suburban communities do, rural communities tend to 
have fewer health care resources overall. A report entitled, ``Rural 
Communities and Emergency Preparedness,'' (published by the Health 
Resources and Services Administration's (HRSA) Office of Rural Health 
Policy, April 2002, found at: ftp://ftp.hrsa.gov/ruralhealth/RuralPreparedness.pdf) addresses the issues faced by rural communities 
with respect to emergency preparedness.
    The authors report that there are many factors that limit the 
ability of rural providers and suppliers to deliver optimal health care 
services in the event of a natural or man-made disaster. The authors 
found that geographic isolation is a significant barrier to providing a 
coordinated emergency response. Rural areas are also more affected by 
variations in weather conditions and by seasonal variations in 
populations (for instance, tourism). As reported by the authors, these 
areas have fewer human and technical resources (that is, health care 
professionals, medical equipment, and communication systems).
    For example, the study found that in 2002, only 20 percent of the 
3,000 local public health departments in the United States had 
developed a plan to deal with a bioterrorism event. The researchers 
also found that the majority of rural public health agencies are closed 
evenings and weekends, and are not equipped to respond to an emergency 
situation on a 24-hour basis. While these factors may not affect a 
rural hospital directly, as an integral part of the larger system of 
health care delivery for its community, a hospital must be ready to 
manage the surge of persons who would seek care at the hospital during 
and after a disaster when many smaller health care entities may be non-
operational.
b. Risk Assessment
    To ensure that all hospitals operate as part of a coordinated 
emergency preparedness system, as outlined in the PPD-8, NIMS, NRF, 
HSPD-21, and PAHPA/PAHPRA, we are proposing at Sec.  482.15 that all 
hospitals establish and maintain an emergency preparedness plan that 
complies with both federal and state requirements. Additionally,

[[Page 79094]]

we propose that a hospital would develop and maintain a comprehensive 
emergency preparedness program, utilizing an ``all-hazards'' approach. 
The emergency preparedness plan would have to be reviewed and updated 
at least annually.
    In keeping with the focus of the emergency management field, we 
propose that prior to establishing an emergency preparedness plan, the 
hospital and all other providers would first perform a risk assessment 
based on utilizing an ``all-hazards'' approach. An all-hazards approach 
is an integrated approach to emergency preparedness planning. In the 
abstract of a November 2007 paper entitled, ``Universal Design: The 
All-Hazards Approach to Vulnerable Populations Planning'' by Charles 
K.T. Ishikawa, MSPH, Garrett W. Simonsen, MSPS, Barbara Ceconi, MSW, 
and Kurt Kuss, MSW, the researchers described an all-hazards planning 
approach as ``a more efficient and effective way to prepare for 
emergencies. Rather than managing planning initiatives for a multitude 
of threat scenarios, all-hazards planning focuses on developing 
capacities and capabilities that are critical to preparedness for a 
full spectrum of emergencies or disasters.'' Thus, all-hazards planning 
does not specifically address every possible threat but ensures that 
hospitals and all other providers will have the capacity to address a 
broad range of related emergencies.
    It is imperative that hospitals perform all-hazards risk assessment 
consistent with the concepts outlined in the National Preparedness 
Guidelines, the ``Guidelines'' published by the U.S. Department of 
Homeland Security that we described in section I.A.3 of this proposed 
rule. Additional guidance and resources for assistance with designing 
and performing a hazard vulnerability assessment include: the 
Comprehensive Preparedness Guide 201: Threat and Hazard Identification 
and Risk Assessment Guide (available at: http://www.fema.gov/library/viewRecord.do?fromSearch=fromsearch&id=5823), the Use of Threat and 
Hazard Identification and Risk Assessment for Preparedness Grants 
(available at: http://www.fema.gov/library/viewRecord.do?fromSearch=fromsearch&id=5826), the Preparedness Guide 
201 Supplement 1: Threat and Hazard Identification and Risk Assessment 
Guide Toolkit (available at: http://www.fema.gov/library/viewRecord.do?fromSearch=fromsearch&id=5825), the Hazard Risk 
Assessment Instrument Workbook (available at: http://www.cphd.ucla.edu/hrai.html) and the Understanding Your Risks: Identifying Hazards and 
Estimating Losses document (available at: http://www.fema.gov/library/viewRecord.do?id=1880).
    Additionally, AHRQ published two additional guides to help hospital 
planners and administrators make important decisions about how to 
protect patients and health care workers and assess the physical 
components of a hospital when a natural or manmade disaster, terrorist 
attack, or other catastrophic event threatens the soundness of a 
facility. The guides examine how hospital personnel have coped under 
emergency situations in the past to better understand what factors 
should be considered when making evacuation, shelter-in-place, and 
reoccupation decisions.
    The guides entitled, ``Hospital Evacuation Decision Guide'' and 
``Hospital Assessment and Recovery Guide'' are intended to supplement 
hospital emergency plans, augment guidance on determining how long a 
decision to evacuate may be safely deferred, and provide guidance on 
how to organize an initial assessment of a hospital to determine when 
it is safe to return after an evacuation.
    The evacuation guide distinguishes between ``pre-event 
evacuations'' which are undertaken in advance of an impending disaster, 
such as a storm, when the hospital structure and surrounding 
environment are not yet significantly compromised and ``post-event 
evacuations,'' which are carried out after a disaster has damaged a 
hospital or the surrounding community. It draws upon past events 
including: the Northridge, CA, earthquake of 1994; the Three Mile 
Island nuclear reactor incident of 1979; and Hurricanes Katrina and 
Rita in 2005. The guide offers advice regarding sequence of patient 
evacuation and factors to consider when a threat looms.
    The assessment and recovery guide helps hospitals determine when to 
get back into a hospital after an evacuation. Comprised primarily of a 
45-page checklist, the guide covers 11 separate areas of hospital 
infrastructure that should be evaluated before determining that it is 
safe to reoccupy a facility, such as security and fire safety, 
information technology and communication and biomedical engineering.
    The ``Hospital Evacuation Decision Guide'' can be found at: http://archive.ahrq.gov/prep/hospevacguide/) (AHRQ Publication No. 10-0009), 
and the ``Hospital Assessment and Recovery Guide'' can be found at 
(http://archive.ahrq.gov/prep/hosprecovery/) (AHRQ Publication No. 10-
0081).
    Based on the guidance and information in these resources, we would 
expect a hospital's risk assessment, which we would require at Sec.  
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 Sec.  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.

[[Page 79095]]

c. Patient Population and Available Services
    At Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  482.15(b) that a hospital be required to 
develop and implement emergency preparedness policies and procedures 
based on the emergency plan proposed at Sec.  482.15(a), the risk 
assessment proposed at Sec.  482.15(a)(1), and the communication plan 
proposed at Sec.  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.

[[Page 79096]]

    We propose at Sec.  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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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

[[Page 79097]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  
482.15(b)(7) that hospitals would have to have a process for the 
development of arrangements with other hospitals and other providers to 
receive patients in the event of limitations or cessation of operations 
at their facilities, to ensure the continuity of services to hospital 
patients.
    We believe this requirement should apply only to providers and 
suppliers that provide continuous care and services for individual 
patients. Thus, we are not proposing this requirement for transplant 
centers; CORFs; OPOs; clinics, rehabilitation agencies, and public 
health agencies as providers of outpatient physical therapy and speech-
language pathology services; and RHCs/FQHCs.
    We also propose at Sec.  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

[[Page 79098]]

local emergency management officials might designate such alternate 
sites, and would plan jointly with local providers on issues related to 
staffing, equipment and supplies at such alternate sites. This 
requirement encourages providers to collaborate with their local 
emergency officials in such proactive planning to allow an organized 
and systematic response to assure continuity of care even when services 
at their facilities have been severely disrupted. Under section 1135 of 
the Act, the Secretary is authorized to temporarily waive or modify 
certain Medicare, Medicaid, and Children's Health Insurance Program 
(CHIP) requirements for health care providers to ensure that sufficient 
health care items and services are available to meet the needs of 
individuals enrolled in these programs in an emergency area (or portion 
of such an area) during any portion of an emergency period. Under an 
1135 waiver, health care providers unable to comply with one or more 
waiver-eligible requirements may be reimbursed and exempted from 
sanctions (absent any determination of fraud or abuse). Requirements to 
which an 1135 waiver may apply include Medicare conditions of 
participation or conditions for coverage and requirements under the 
Emergency Medical Treatment and Labor Act (EMTALA). The 1135 waiver 
authority applies only to specific federal requirements and does not 
apply to any state requirements, including licensure.
    In determining whether to invoke an 1135 waiver (once the 
conditions precedent to the authority's exercise have been met), the 
ASPR with input from relevant HHS operating divisions (OPDIVs) 
determines the need and scope for such modifications, considers 
information such as requests from Governor's offices, feedback from 
individual healthcare providers and associations, and requests from 
regional or field offices for assistance. Additional information 
regarding the 1135 waiver process is provided in the CMS Survey and 
Certification document entitled, ``Requesting an 1135 Waiver'', and 
located at: http://www.cms.gov/About-CMS/Agency-Information/H1N1/downloads/requestingawaiver101.pdf.
    Providers must resume compliance with normal rules and regulations 
as soon as they are able to do so. Waivers or modifications permitted 
under an 1135 waiver are no longer available after the termination of 
the emergency period. Generally, federally certified or approved 
providers must operate under normal rules and regulations, unless they 
have sought and have been granted modifications under the waiver 
authority from specific requirements.
    When a waiver has been issued under section 1135(b)(3) of the Act, 
EMTALA sanctions do not apply to a hospital with a dedicated emergency 
department, providing the conditions at Sec.  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-hospital-based ACSs. It describes 
different types of ACSs, including critical issues and decisions that 
will need to be made regarding these sites during an MCE; addresses 
potential barriers; and includes examples of case studies.
    Subsequently, on October 1, 2009, AHRQ released two Disaster 
Alternate Care Facility Selection Tools, entitled the ``Disaster 
Alternate Care Facility Selection Tool'' and the ``Alternate Care 
Facility Patient Selection Tool to help emergency planners and 
responders select and run alternate care facilities during disaster 
situations. These two tools can be found at: http://archive.ahrq.gov/prep/acfselection/pselectmatrix/(S(fidfow2u5az1o155srb0h1nb))/
default.aspx and at: 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

[[Page 79099]]

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 Sec.  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 Sec.  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 Sec.  
482.15(c)(2) requiring hospitals to have contact information for 
federal, state, tribal, regional, or local emergency preparedness staff 
and other sources of assistance. Patient care must be well-coordinated 
within the hospital, across health care providers, and with state and 
local public health departments and emergency systems to protect 
patient health and safety in the event of a disaster. Again, we support 
hospitals and other providers engaging in coalitions in their area for 
assistance in effectively meeting this requirement.
    We propose to require at Sec.  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 Sec.  
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 Sec.  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 Sec.  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

[[Page 79100]]

to develop and maintain their own system.
    We propose at Sec.  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 Sec.  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 Sec.  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 Sec.  482.15(d)(2), we would require 
hospitals to conduct drills and exercises to test the emergency plan. 
We propose at Sec.  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 Sec.  482.15(d)(2)(ii) that if a 
hospital experienced an actual natural or man-made emergency that 
required activation of the emergency plan, the hospital would be exempt 
from engaging in a community or individual, facility-based mock 
disaster drill for 1 year following the actual event.
    We propose at Sec.  482.15(d)(2)(iii) requiring a hospital to 
conduct a paper-based, tabletop exercise at least annually. The 
tabletop exercise could be based on the same or a different disaster 
scenario from the scenario used in the mock disaster drill or the 
actual emergency. In the proposed regulations text, we would define a 
tabletop exercise as a ``group discussion led by a facilitator, using a 
narrated, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.''
    Comprehensive emergency preparedness includes anticipating and 
adequately addressing the various natural and man-made disasters that 
could impact a given facility. We expect that 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/bhpp-train-hospital-toolkit-01.pdf), which may help 
hospitals and other providers and suppliers that have limited or no 
emergency preparedness training experience. This document is designed 
to walk a facility through the process of performing a tabletop 
exercise and after-event analysis. The toolkit consists of things to 
consider before engaging in a tabletop exercise, the process of 
planning the exercise, running the exercise, evaluating the exercise 
and its impact, and public health emergency scenarios for tabletop 
exercises, including the plague, Sever Acute Respiratory Syndrome 
(SARS), anthrax, smallpox, and pandemic flu.
    There are also other training resources that may prove useful for 
hospitals and other providers and suppliers to comply with as they 
attempt to meet this proposed emergency preparedness

[[Page 79101]]

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 pilot-
tested at three metropolitan-area local public health agencies in three 
separate states from August through November 2005.
    Finally, the Centers for Medicare & Medicaid Services (CMS), Survey 
and Certification Group has developed a document entitled, the Health 
Care Provider After Action Report/Improvement Plan (AAR/IP) template 
with the assistance of the U.S. Department of Health and Human Services 
(HHS), Office of the Assistant Secretary for Preparedness and Response, 
the U.S. Department of Homeland Security (DHS), and the CMS Survey and 
Certification Emergency Preparedness Stakeholder Communication Forum. 
The template can be accessed at http://www.cms.gov/SurveyCertEmergPrep/03_HealthCareProviderGuidance.asp and then scrolling down to click on 
the download entitled, the ``Health Care Provider Voluntary After 
Action Report/Improvement Plan Template and Instructions for 
Completion.'' The AAR/IP was intended to be a voluntary, user-friendly 
tool for health care providers to use to document their performance 
during emergency planning exercises and real emergency events to make 
recommendations for improvements for future performance. We do not 
mandate use of this AAR/IP template; however thorough completion of the 
template complies with our requirements for provider exercise 
documentation.
    The ``Health Care Provider After Action Report/Improvement Plan'' 
template also meets requirements for hospitals or other health care 
providers wishing to ensure their compliance with the Hospital 
Preparedness Program (HPP).
    This AAR/IP template is based on the U.S. Department of Homeland 
and Security Exercise and Evaluation Program (HSEEP) Vol. III, issued 
in February 2007, which includes guidelines that are focused towards 
emergency management agencies and other governmental/non-governmental 
agencies. The HSEEP is a capabilities and performance-based exercise 
program that provides a standardized methodology and terminology for 
exercise design, development, conduct, evaluation, and improvement 
planning. Health care providers may also use the AAR/IP to document 
real life emergency events and can customize or personalize the CMS 
``Health Care Provider AAR/IP'' template to best meet their needs.
    There are seven types of exercises defined within HSEEP, each of 
which is either discussions-based or operations-based.
    Discussions-based exercises familiarize participants with current 
plans, policies, agreements and procedures, or may be used to develop 
new plans, policies, agreements, and procedures.
    Types of discussion-based exercises include the following:
     Seminar: A seminar is an informal discussion, designed to 
orient participants to new or updated plans, policies, or procedures 
(for example, a seminar to review a new Evacuation Standard Operating 
Procedure).
     Workshop: A workshop resembles a seminar, but is employed 
to build specific products, such as a draft plan or policy (for 
example, a Training and Exercise Plan Workshop is used to develop a 
Multiyear Training and Exercise Plan).
     Tabletop Exercise (TTX): A tabletop exercise involves key 
personnel discussing simulated scenarios in an informal setting. TTXs 
can be used to assess plans, policies, and procedures.
     Games: A game is a simulation of operations that often 
involves two or more teams, usually in a competitive environment, using 
rules, data, and procedure designed to depict an actual or assumed 
real-life situation.
    Operations-based exercises validate plans, policies, agreements and 
procedures, clarify roles and responsibilities, and identify resource 
gaps in an operational environment. Types of operations-based exercises 
include the following:
     Drill: A drill is a coordinated, supervised activity 
usually employed to test a single, specific operation or function 
within a single entity (for example, a nursing home conducts an 
evacuation drill).
     Functional exercise (FE): A functional exercise examines 
or validates the coordination, command, and control between various 
multi-agency coordination centers (for example, emergency operation 
center, joint field office, etc.). A functional exercise does not 
involve any ``boots on the ground'' (that is, first responders or 
emergency officials responding to an incident in real time).
     Full-Scale Exercise (FSE): A full-scale exercise is a 
multi-agency, multi-jurisdictional, multi-discipline exercise involving 
functional (for example, joint field office, emergency operation 
centers, etc.) and ``boots on the ground'' response (for example, 
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 Sec.  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 Sec.  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,

[[Page 79102]]

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Policies and                                                           Additional
           Provider type                 Emergency plan            procedures          Communication plan    Training and testing       requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Inpatient Providers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hospital...........................  *Develop a plan based   *Develop and implement  *Develop and maintain  *Develop and maintain  Generators--Develop
                                      on a risk assessment    policies and            an emergency           training and testing   policies and
                                      using an ``all          procedures based on     preparedness           programs, including    procedures that
                                      hazards'' approach,     the emergency plan      communication plan     initial training in    address the
                                      which is an             and risk assessment,    that complies with     policies and           provision of
                                      integrated approach     which must be           both federal and       procedures and         alternate sources of
                                      focusing on             reviewed and updated    state law. Patient     demonstrate            energy to maintain:
                                      capacities and          at least annually.      care must be well-     knowledge of           (1) temperatures to
                                      capabilities critical                           coordinated within     emergency procedures   protect patient
                                      to preparedness for a                           the facility, across   and provide training   health and safety
                                      full spectrum of                                health care            at least annually.     and for the safe and
                                      emergencies and                                 providers and with     Conduct drills and     sanitary storage of
                                      disasters. The plan                             state and local        exercises to test      provisions; (2)
                                      must be updated                                 public health          the emergency plan.    emergency lighting;
                                      annually.                                       departments and                               (3) fire detection,
                                                                                      emergency systems.                            extinguishing, and
                                                                                                                                    alarm systems.
Critical Access Hospital...........  *.....................  *.....................  *....................  *....................  Generators.
Long Term Care Facility............  Must account for        *.....................  Share with resident/   *....................  Generators.
                                      missing residents                               family/
                                      (existing                                       representative
                                      requirement).                                   appropriate
                                                                                      information from
                                                                                      emergency plan
                                                                                      (additional
                                                                                      requirement).
PRTF...............................  *.....................  *.....................  *....................  *                      .....................
ICF/IID............................  Must account for        *.....................  Share with client/     *                      .....................
                                      missing clients                                 family/
                                      (existing                                       representative
                                      requirement).                                   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--      In home services--     *....................  .....................
                                                              inform officials of     will not need to
                                                              patients in need of     provide occupancy
                                                              evacuation              information.
                                                              (additional
                                                              requirement).
Ambulatory Surgical Center.........  *.....................  *.....................  Will not need to       *....................  .....................
                                                                                      provide occupancy
                                                                                      information.
PACE...............................  *.....................  Inform officials of     Will not need to       *....................  .....................
                                                              patients in need of     provide occupancy
                                                              evacuation              information.
                                                              (additional
                                                              requirement).

[[Page 79103]]

 
Home Health Agency.................  *.....................  Will not require        Will not need to       *                      .....................
                                                              shelter in place,       provide occupancy
                                                              provision of care at    information.
                                                              alternate care sites.
                                                             Inform officials of
                                                              patients in need of
                                                              evacuation
                                                              (additional
                                                              requirement).
CORF...............................  Must develop emergency  Will not need to        Will not need to       Assign specific        .....................
                                      plan with assistance    provide                 provide occupancy      emergency
                                      from fire, safety       transportation to       information.           preparedness tasks
                                      experts (existing       evacuation locations,                          to new personnel.
                                      requirement).           or have arrangements                           Provide instruction
                                                              with other CORFs to                            in location, use of
                                                              receive patients.                              alarm systems,
                                                                                                             signals &
                                                                                                             firefighting equip
                                                                                                             (existing
                                                                                                             requirements).
CMHC...............................  *.....................  *.....................  *....................  *....................  .....................
OPO................................  Address type of         Needs to have system    Does not need to       Only tabletop          Must maintain
                                      hospitals OPO has       to track staff during   provide occupancy      exercise.              agreement with other
                                      agreement (additional   & after emergency and   info, method of                               OPOs & hospitals.
                                      requirement).           maintain medical        sharing pt. info,
                                                              documentation           providing info on
                                                              (additional             general condition &
                                                              requirement).           location of patients.
Clinics, Rehabilitation, and         Must develop emergency  *.....................  Does not need to       *                      .....................
 Therapy.                             plan with assistance                            provide occupancy
                                      from fire, safety                               information.
                                      experts. Address
                                      location, use of
                                      alarm systems and
                                      signals & methods of
                                      containing fire
                                      (existing
                                      requirements).
RHC/FQHC...........................  *.....................  Appropriate placement   Does not need to       *                      .....................
                                                              of exit signs           provide occupancy
                                                              (existing               information.
                                                              requirement).
                                                             Does not have to track
                                                              patients, or have
                                                              arrangements with
                                                              other RHCs to receive
                                                              patients or have
                                                              alternate care sites.

[[Page 79104]]

 
ESRD...............................  Must contact local      Policies and            Does not need to       Ensure staff           .....................
                                      emergency               procedures must         provide occupancy      demonstrate
                                      preparedness agency     include emergencies     information.           knowledge of
                                      annually to ensure      regarding fire                                 emergency
                                      dialysis facility's     equipment, power                               procedures,
                                      needs in an emergency   failures, care                                 informing patients
                                      (existing               related emergencies,                           what to do, where to
                                      requirement).           water supply                                   go, whom to contact
                                                              interruption &                                 if emergency occurs
                                                              natural disasters                              while patient is not
                                                              (existing                                      in facility
                                                              requirement).                                  (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) (Sec.  403.748)

    Section 1861(ss)(1) of the Act defines the term ``Religious 
Nonmedical Health Care Institution'' (RNHCI) and lists the requirements 
that a RNHCI must meet to be eligible for Medicare participation.
    We have implemented these provisions in 42 CFR part 403, Subpart G, 
``Religious Nonmedical Health Care Institutions' Benefits, Conditions 
of Participation, and Payment.'' As of March 2012, there were 16 
Medicare-certified RNHCIs that were subject to the RNHCI regulations 
and were receiving payment for services provided to Medicare or 
Medicaid patients.
    A RNHCI is a facility that is operated under all applicable 
federal, state, and local laws and regulations, which furnishes only 
non-medical items and services on a 24-hour basis to beneficiaries who 
choose to rely solely upon a religious method of healing and for whom 
the acceptance of medical services would be inconsistent with their 
religious beliefs. The religious non-medical care or religious method 
of healing means care provided under the established religious tenets 
that prohibit conventional or unconventional medical care for the 
treatment of the patient and exclusive reliance on the religious 
activity to fulfill a patient's total health care needs.
    Thus, Medicare would cover the nonmedical, non-religious health 
care items and services in a RNHCI for beneficiaries who would qualify 
for hospital or skilled nursing facility care but for whom medical care 
is inconsistent with their religious beliefs. Medicare does not cover 
the religious aspects of care. Nonmedical items and services are 
furnished to inpatients exclusively through nonmedical nursing 
personnel. Such Medicare coverage would include both nonmedical items 
that do not require a doctor's order or prescription (such as wound 
dressings or use of a 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 Sec.  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 Sec.  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 Sec.  
403.742(a)(1), (4), and (5) at proposed Sec.  403.748(a) and Sec.  
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 Sec.  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 Sec.  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 Sec.  482.15(a)(1) would be 
modified for RNHCIs. At proposed Sec.  403.748(a)(1),

[[Page 79105]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  403.748(b)(7) we added the term 
``non-medical'' to accommodate the uniqueness of the RNHCI non-medical 
care.
    The proposed hospital requirement at Sec.  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 Sec.  
482.15(c)(4), at proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  482.15(d)(2)(ii) that if the 
hospital experienced an actual natural or man-made emergency, the 
hospital would be exempt from engaging in a community or individual, 
facility-based mock disaster drill for 1 year following the onset of 
the actual event, we are not proposing this requirement for RNHCIs.
    At Sec.  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 
Sec.  403.748(d)(2)(d)(ii), for RNHCIs, we propose to remove reference 
to drills.
    Currently, at existing Sec.  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 Sec.  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) (Sec.  416.54)

    Section 416.2 defines an ambulatory surgical center (ASC) as any 
distinct entity that operates exclusively for the purpose of providing 
surgical services to patients not requiring hospitalization, and in 
which the expected duration of services would not exceed 24 hours 
following an admission.
    Section 1833(i)(1)(A) of the Act authorizes the Secretary to 
specify those surgical procedures that can be performed safely in an 
ASC. The surgical services performed in ASCs generally are scheduled, 
elective, non-life-threatening procedures that can be safely performed 
in either a hospital setting (inpatient or outpatient) or in a 
Medicare-certified ASC.
    Patients are examined immediately before surgery to evaluate the 
risk of anesthesia and of the procedure to be performed. Patients also 
are evaluated just prior to discharge from the ASC to ensure proper 
anesthesia recovery.
    Currently, there are 5,354 Medicare certified ASCs in the U.S. The 
ASC Conditions for Coverage (CfCs) at 42 CFR part 416, Subpart C are 
the minimum health and safety standards a facility must meet to obtain 
Medicare certification. The existing ASC CfCs do not contain 
requirements that address emergency situations. However, existing Sec.  
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 Sec.  416.41(c). Existing Sec.  
416.41(c)(1) would be incorporated into proposed Sec.  416.54(a),

[[Page 79106]]

(a)(1), (a)(2), and (a)(4). Existing Sec.  416.41(c)(2) would be 
incorporated into proposed Sec.  416.54(a)(4) and (c)(2). Existing 
Sec.  416.41(c)(3) would be incorporated into proposed Sec.  
416.54(d)(2)(i) and Sec.  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 Sec.  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 (Sec.  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 Medicare-participating 
hospice. Under the authority of section 1861(dd) of the Act, the 
Secretary has established the CoPs that a hospice must meet in order to 
participate in Medicare and Medicaid. Under section 1861(dd) of the 
Act, the Secretary is responsible for ensuring that the CoPs and their 
enforcement are adequate to protect the health and safety of patients 
under hospice care. To implement this requirement, state survey 
agencies conduct surveys of hospices to assess their compliance with 
the CoPs. The CoPs found at part 418, Subparts C and D apply to a 
hospice, as well as to the services furnished to each patient under 
hospice care.
    Hospice care provides palliative care rather than traditional 
medical care and curative treatment to terminally ill patients. 
Palliative care improves the quality of life of patients and their 
families facing the problems associated with terminal illness through 
the prevention and relief of suffering by means of early 
identification, assessment, and treatment of pain and other issues. 
Hospice care allows the patient to remain at home as long as possible 
by providing support to the patient and family and by keeping the 
patient as comfortable as possible while maintaining his or her dignity 
and quality of life. Hospices use an interdisciplinary approach to 
deliver medical, social, physical, emotional, and spiritual services 
through the use of a broad spectrum of caregivers.
    Hospices are unique health care providers because they serve 
patients and their families in a wide variety of settings. Hospice 
patients may be served in their place of residence, whether that 
residence is a private home, a nursing home, an assisted living 
facility, or even a recreational vehicle, as long as such locations are 
determined to be the patient's place of residence. Hospice patients may 
also be served in inpatient facilities operated by the hospice.
    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 Sec.  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 Sec.  
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 Sec.  418.110(c)(1)(ii) into proposed Sec.  418.113(a)(2) and 
proposed Sec.  418.113(d)(1). We would require at Sec.  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 Sec.  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 Sec.  
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 man-made emergency.
    Despite these core differences, we believe the hospital emergency 
preparedness requirement, with some reorganization and revision, is 
appropriate for hospice providers. Thus, our discussion will focus on 
the requirements as they differ from the requirements for hospitals 
within the context of the hospice setting. Since hospices serve 
patients in both the community and within various types of facilities, 
we propose to re-organize the requirements for the hospice provider's 
policies and procedures differently from the proposed policies and 
procedures for hospitals. Specifically, we propose to group 
requirements that apply to all hospice providers at Sec.  418.113(b)(1) 
through Sec.  418.113(b)(5) followed by requirements at Sec.  
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

[[Page 79107]]

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 Sec.  
418.113(c) are the same as for hospitals, with the exception of 
proposed Sec.  418.113(c)(7). At Sec.  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 Sec.  418.113(d) are 
similar to those proposed for hospitals.

E. Emergency Preparedness Regulation for Inpatient Psychiatric 
Residential Treatment Facilities (PRTFs) (Sec.  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 Sec.  441.150 through Sec.  441.182 and Sec.  
483.350 through Sec.  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) (Sec.  460.84)

    The Balanced Budget Act (BBA) of 1997 established the Program of 
All-Inclusive Care for the Elderly (PACE) as a permanent Medicare and 
Medicaid provider type. Under sections 1894 and 1934 of the Act, a 
state participating in PACE must have a program agreement with CMS and 
a PACE organization. Regulations at Sec.  460.2 describe the statutory 
authority that permits entities to establish and operate PACE programs 
under section 1894 and 1934 of the Act and Sec.  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 Sec.  
460.72(c)(1) through (5) and incorporate these existing requirements 
into proposed Sec.  460.84, Emergency preparedness requirements for 
Programs of All-Inclusive Care for the Elderly (PACE).
    Existing Sec.  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 Sec.  
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 Sec.  460.72(c)(1) into 
Sec.  460.84(b). Existing Sec.  460.72(c)(2), which defines the various 
emergencies, would be incorporated into Sec.  460.84(b) as well. The 
statement in current Sec.  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

[[Page 79108]]

hazards'' approach as proposed in Sec.  460.84(a)(1).
    Existing Sec.  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 Sec.  
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 Sec.  460.72(c)(4) would be relocated 
to proposed Sec.  460.84(b)(9). Finally, current Sec.  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 Sec.  460.84(d)(2). The 
current version of Sec.  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 Sec.  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 
Sec.  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 Sec.  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 
(Sec.  482.15(c)(7)), since the term occupancy usually refers to bed 
occupancy in an inpatient facility.

G. Emergency Preparedness Regulations for Transplant Centers (Sec.  
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 Sec.  
482.1 through Sec.  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 Sec.  482.72 
through Sec.  482.104.
    Transplant centers are responsible for providing organ 
transplantation services from the time of the potential transplant 
candidate's initial evaluation through the recipient's post-transplant 
follow-up care. In addition, if a center performs living donor 
transplants, the center is responsible for the care of the living donor 
from the time of the initial evaluation through post-surgical follow-up 
care.
    Organs are viable for transplantation for a limited time after 
organ recovery. Although kidneys may remain viable for transplantation 
for more than 24 hours, other organs remain viable for only a few 
hours. Thus, according to the Organ Procurement and Transplantation 
Network (OPTN) longstanding policy, if a transplant center must turn 
down an organ for one of its patients, the organ may go to the next 
patient on the waiting list at another transplant center (Organ 
Distribution: Organ Procurement, Distribution and Allocation, http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_6.pdf) . In such a situation, the patient on the waiting list of the 
transplant center experiencing an emergency may die before an organ 
becomes available again. In fact, according to the OPTN, about 18 
patients die every day waiting for an organ transplant. (http://optn.transplant.hrsa.gov/)
    There are 770 Medicare-approved transplant centers. These centers 
provide specialized services that are not available at all hospitals. 
Thus, we believe that it is crucial for every transplant center to make 
arrangements with one or more other Medicare-approved transplant 
centers to provide transplantation services and other care to its 
patients during an emergency. Making such arrangements would increase 
the likelihood that if an organ became available for one of the 
transplant center's waiting list patients during an emergency, the 
patient would receive the transplant. Further, having such arrangements 
with other transplant centers would increase the odds that during an 
emergency, a transplant center's patients would receive critically 
important post-transplant care to prevent graft failure.
    Our regulations at Sec.  482.68 currently require that a transplant 
center that has a Medicare provider agreement meet the hospital CoPs 
specified in Sec.  482.1 through Sec.  482.57. Our proposed hospital 
CoP, ``Emergency preparedness,'' at Sec.  482.15, would apply to 
transplant centers. We also propose to add a new transplant center CoP 
at Sec.  482.78, ``Emergency preparedness''. A transplant center would 
be required to comply with the proposed emergency preparedness hospital 
requirements at Sec.  482.15, as well as the proposed CoP for emergency 
preparedness for transplant centers at Sec.  482.78. We propose at 
Sec.  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

[[Page 79109]]

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 Sec.  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 Sec.  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 Sec.  482.78(b) to require transplant centers to ensure that 
the written agreement required under Sec.  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 Sec.  
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 Sec.  482.15(b)(1). Also, we are not proposing to require 
transplant centers to separately comply with the proposed hospital 
requirement at Sec.  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 (Sec.  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 Sec.  
483.73(a)(1). Existing Sec.  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 Sec.  483.73(d)(1)and 
(d)(2). Sections Sec.  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 Sec.  482.15, with two 
exceptions. Specifically, at Sec.  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 Sec.  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 
Sec.  483.73(c)(8) that reads, ``A method for sharing information from 
the emergency plan that the facility has determined is

[[Page 79110]]

appropriate with residents and their families or representatives.''
    Also, as discussed in section II.A.4 of the preamble we are 
proposing at Sec.  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 Sec.  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) (Sec.  
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, Sec.  483.400 through Sec.  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 Sec.  
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 
Sec.  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 Sec.  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, Sec.  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 Sec.  483.430(c)(2) and Sec.  
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 Sec.  483.470, Physical environment, includes a standard 
for emergency plan and procedures at Sec.  483.470(h) and a standard 
for evacuation drills at Sec.  483.470(i). The standard for emergency 
plan and procedures at current Sec.  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 
Sec.  483.475(a)(1). Existing Sec.  483.470(h)(1) would be removed.
    Currently Sec.  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 Sec.  483.475(d). Current 
Sec.  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

[[Page 79111]]

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 Sec.  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 Sec.  
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 Sec.  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 Sec.  483.470(i)(3), facilities must meet the 
requirements of paragraphs Sec.  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 Sec.  483.470(i) 
(redesignated as Sec.  483.470(h)) at proposed Sec.  483.475(d).

J. Emergency Preparedness Regulations for Home Health Agencies (HHAs) 
(Sec.  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 
Sec.  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 Sec.  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 Sec.  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 Sec.  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 (Sec.  482.15(b)(1)); safe evacuation (Sec.  
482.15(b)(3)); and a means to shelter in place (Sec.  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 Sec.  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 Sec.  482.15(c)(5). We 
have also modified the proposed requirement for hospitals at Sec.  
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 Sec.  
484.22(c)(6), we would require HHAs to provide information

[[Page 79112]]

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) (Sec.  485.68)

    Section 1861(cc) of the Act defines the term ``comprehensive 
outpatient rehabilitation facility'' (CORF) and lists the requirements 
that a CORF must meet to be eligible for Medicare participation. By 
definition, a CORF is a non-residential facility that is established 
and operated exclusively for the purpose of providing diagnostic, 
therapeutic, and restorative services to outpatients for the 
rehabilitation of injured, sick, and persons with disabilities, at a 
single fixed location, by or under the supervision of a physician. As 
of March 2013, there were 272 Medicare-certified CORFs in the U.S.
    Section 1861(cc)(2)(J) of the Act also states that the CORF must 
meet other requirements that the Secretary finds necessary in the 
interest of the health and safety of a CORF's patients. Under this 
authority, the Secretary has established in regulations, at part 485, 
Subpart B, requirements that a CORF must meet to participate in the 
Medicare program.
    Currently Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  482.15(b)(2).
    At Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  482.15(c)(7), at Sec.  
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

[[Page 79113]]

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 Sec.  485.64(b)(2) would be 
relocated to proposed Sec.  485.68(d)(1).
    Currently Sec.  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 Sec.  
485.68(a)(5). Currently Sec.  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 Sec.  485.68(d)(1). We propose to remove 
current Sec.  485.64.

L. Emergency Preparedness Regulations for Critical Access Hospitals 
(CAHs) (Sec.  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 well-coordinated 
emergency preparedness system of care.
    CAHs are required at existing Sec.  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 Sec.  485.623(c) and 
relocate these requirements into the appropriate sections of a new CoP 
entitled, ``Condition of Participation: Emergency Preparedness'' at 
Sec.  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 Sec.  485.623(c)(1) to proposed 
Sec.  485.625(d)(1). We propose to incorporate current Sec.  
485.623(c)(2) into Sec.  485.625(b)(1). Current Sec.  485.623(c)(3) 
would be included in proposed Sec.  485.625(b)(1). Current Sec.  
485.623(c)(4) would be reflected by the use of the term ``all-hazards'' 
in proposed Sec.  485.625(a)(1). Section 485.623(d) would be 
redesignated as Sec.  485.623 (c).
    Also, as discussed in section II.A.4 of the preamble we are 
proposing at Sec.  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 (Sec.  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 speech-language pathology services. In the remainder of 
this proposed rule and throughout the requirements, we use the

[[Page 79114]]

term ``organizations'' instead of ``clinics, rehabilitation agencies, 
and public health agencies as providers of outpatient physical therapy 
and speech-language pathology services'' for consistency with current 
regulatory language. Most of these providers are small facilities 
operated by a group of three or more physicians, as required at Sec.  
485.703 under the definition of ``clinic'', practicing medicine 
together, as well as various other rehabilitation professionals.
    At Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  
485.727(a)(6).
    Existing requirements at Sec.  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 Sec.  485.727(a)(4).
    Currently Sec.  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 Sec.  485.727(d), we do not propose to 
relocate them but merely to address them in that paragraph. Current 
Sec.  485.727, ``Disaster preparedness,'' would be removed.

N. Emergency Preparedness Regulations for Community Mental Health 
Centers (CMHCs) (Sec.  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 Sec.  
410.110 and conditions for Medicare payment of partial hospitalization 
services at Sec.  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

[[Page 79115]]

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 Sec.  485.920(c)(7), we propose to require these 
CMHCs to have a communication plan that include a means of providing 
information about the CMHCs needs and its ability to provide assistance 
to the authority having jurisdiction or the Incident Command Center, or 
designee.
    Some CMHCs are small facilities with just a few clients and may be 
located in rural areas. These CMHCs could find it challenging to 
develop a well-coordinated emergency preparedness plan. However, we 
believe even small CMHCs would be able to develop an appropriate 
emergency preparedness plan with the assistance of federal, state, and 
local community resources.

O. Emergency Preparedness Regulations for Organ Procurement 
Organizations (OPOs) (Sec.  486.360)

    Section 1138(b) of the Act and 42 CFR part 486, subpart G establish 
that OPOs must be certified by the Secretary as meeting the 
requirements to be an OPO and designated by the Secretary for a 
specific Donation Service Area (DSA). The current OPO CfCs do not 
contain any emergency preparedness requirements.
    There are currently 58 Medicare certified OPOs that are responsible 
for identifying potential organ donors in hospitals, assessing their 
suitability for donation, obtaining consent from next-of-kin, managing 
potential donors to maintain organ viability, coordinating recovery of 
organs, and arranging for transport of organs to transplant centers. If 
an emergency affects an 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 Sec.  486.360(a)(3), instead of addressing the patient 
population as proposed for hospitals at Sec.  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 Sec.  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 Sec.  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 Sec.  
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 Sec.  
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 Sec.  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 Sec.  486.322(a) and in the protocols with transplant 
programs required under Sec.  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) (Sec.  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 Sec.  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.

[[Page 79116]]

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 Sec.  491.6, under ``Physical plant and 
environment.'' At Sec.  491.6(c)(1), the RHC or FQHC must train staff 
in handling non-medical emergencies. This requirement would be 
addressed at proposed Sec.  491.12(d)(1). At Sec.  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 
Sec.  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 Sec.  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 Sec.  491.12(a)(1), which 
requires the RHCs and FQHCs to perform a risk assessment based on an 
``all-hazards'' approach. Current Sec.  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 Sec.  
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 Sec.  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 Sec.  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 
Sec.  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 Sec.  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 Sec.  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 Sec.  
482.15(c)(7), at Sec.  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 (Sec.  494.62)

    Sections 1881(b), 1881(c), and 1881(f)(7) of the Act establish 
requirements for End-Stage Renal Disease (ESRD) facilities. ESRD is a 
kidney impairment that is irreversible and permanent and requires 
either a regular course of dialysis or kidney transplantation to 
maintain life. Dialysis is the process of cleaning the blood and 
removing excess fluid artificially with special equipment when the 
kidneys have failed. There are 5,923 Medicare-participating ESRD 
facilities in the U.S.
    We addressed emergency preparedness requirements for ESRD 
facilities in the April 15, 2008 final rule (73 FR 20370) entitled, 
``Conditions for Coverage for End-Stage Renal Disease Facilities; Final 
Rule''. Emergency preparedness requirements are located at Sec.  
494.60(d), Condition: Physical environment, Standard: Emergency 
preparedness. We propose to relocate these existing requirements to 
proposed Sec.  494.62, Emergency preparedness.
    Current regulations include the requirement that dialysis 
facilities be organized into ESRD Network areas. Our regulations 
describe these networks at Sec.  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 Sec.  482.15(b)(1).
    At Sec.  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 Sec.  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 Sec.  494.62(b)(2), we are proposing to 
require that ESRD facilities have policies and procedures for 
evacuation from the facility,

[[Page 79117]]

including staff responsibilities and needs of the patients.
    At Sec.  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 Sec.  494.62(c)(7), dialysis facilities would be required to 
comply with the proposed requirement for hospitals at Sec.  
482.15(c)(7), with one exception. At Sec.  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 Sec.  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 
Sec.  494.60(d)(2) to proposed Sec.  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 Sec.  494.60(d) would be redesignated. Current requirements 
for emergency plans at Sec.  494.60 are captured within proposed Sec.  
494.62(a). Current language that defines an emergency for dialysis 
facilities found at Sec.  494.60(d) would be incorporated into proposed 
Sec.  494.62(b). We would relocate existing requirements for emergency 
equipment and emergency drugs found at existing Sec.  494.60(d)(3) to 
Sec.  494.62(b)(9). We would relocate the existing requirement at Sec.  
494.60(d)(4)(i) that requires the facility to have a plan to obtain 
emergency medical system assistance when needed to proposed Sec.  
494.62(b)(8). We would relocate the current requirements at Sec.  
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 Sec.  
494.62(a)(4). We would also redesignate the current Sec.  494.60(e) as 
Sec.  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 TJC-accredited 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

[[Page 79118]]

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/emergencypreparedness
Federal Emergency Management Agency (FEMA)--State Offices and Agencies 
of Emergency Management--Contact Information
 http://www.fema.gov/about/contact/statedr.shtm
 http://www.fema.gov/plan-prepare-mitigate
Department of Homeland Security (DHS)
 http://www.dhs.gov/training-technical-assistance

    We will discuss the burden for each provider and supplier type 
included in this proposed rule in the order in which they appear in the 
CFR.

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

    Proposed Sec.  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 Sec.  
403.748(a)(1) through (4). We will discuss the burden for these 
activities individually beginning with the risk assessment requirement 
in Sec.  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

[[Page 79119]]

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 x 16 RNHCIs = 144 burden hours) for all 16 
RNHCIs to comply with this requirement at a cost of $4,240 ($265 
estimated cost for each RNHCI x 16 RNHCIs = $4,240 estimated cost).
    After conducting a risk assessment, RNHCIs would need to review, 
revise, and, if necessary, develop new sections for their emergency 
plans. The current RNHCI CoPs require RNHCIs to have a written disaster 
plan for emergencies (42 CFR Sec.  403.742(a)(4)). However, based on 
our experience with RNHCIs, their plans likely would address only 
evacuation from their facilities. We expect that all RNHCIs would need 
to review, revise, and develop new sections for their plans.
    We expect that the same individuals who were involved in developing 
the risk assessment would be involved in developing the emergency 
preparedness plan. However, we expect that it would require 
substantially more time to complete the plan than to complete the risk 
assessment. We estimate that complying with this requirement would 
require 12 burden hours for each RNHCI at a cost of $348. Therefore, 
for all 16 RNHCIs to comply with these requirements would require an 
estimated 192 burden hours (12 burden hours for each RNHCI x 16 RNHCIs 
= 192 burden hours) at a cost of $5,568 ($348 estimated cost for each 
RNHCI x 16 RNHCIs = $5,568 estimated cost).
    Under this proposed rule, RNHCIs would be required to review and 
update their emergency preparedness plans at least annually. For the 
purpose of determining the burden associated with this requirement, we 
would expect that RNHCIs already review their plans annually. Based on 
our experience with Medicare providers and suppliers, health care 
facilities generally have a compliance officer or other staff member 
who periodically reviews the facility's program to ensure that it 
complies with all relevant federal, state, and local laws, regulations, 
and ordinances. While this requirement is subject to the PRA, we expect 
that complying with the requirement for an annual review of the 
emergency preparedness plan would constitute a usual and customary 
business practice as defined at 5 CFR 1320.3(b)(2). Therefore, we have 
not assigned a burden.
    Proposed Sec.  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 
Sec.  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 Sec.  403.738). Thus, some RNHCIs may 
have some emergency preparedness policies and procedures. However, 
based on our experience with RNHCIs, most of their emergency 
preparedness policies address only evacuation from the facility.
    We expect that these tasks would involve the administrator, the 
director of nursing, and the head of maintenance. All three would need 
to review and comment on the RNHCI's current policies and procedures. 
The director of nursing would revise or develop new policies and 
procedures, as needed, ensure that they are approved, and compile and 
disseminate them to the appropriate parties. We estimate that it would 
require 6 burden hours for each RNHCI to comply with this requirement 
at a cost of $164. Thus, it would require 96 burden hours (6 burden 
hours for each RNHCI x 16 RNHCIs = 96 burden hours) for all 16 RNHCIs 
to comply with the requirements in Sec.  403.748(b)(1) through (8) at a 
cost of $2,624 ($164 estimated cost for each RNHCI x 16 RNHCIs = $2,624 
estimated cost).
    Proposed Sec.  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 Sec.  403.748(c)(1) through (7). The burden 
associated with complying with this requirement would be the resources 
required to review and, if necessary, revise an existing communication 
plan or develop a new plan. Based on our experience with RNHCIs, we 
expect that these activities would require the involvement of the 
RNHCI's administrator, the director of nursing, and the head of 
maintenance. We estimate that complying with this requirement would 
require 4 burden hours for each RNCHI at a cost of $116. Thus, it would 
require an estimated 64 burden hours (4 burden hours for each RNHCI x 
16 RNHCIs = 64 burden hours) at a cost of $1,856 ($116 estimated cost 
for each RNHCI x 16 RNHCIs = $1,856 estimated cost).
    We propose that RNHCIs would also have to review and update their 
emergency preparedness communication plan at least annually. We believe 
that RNHCIs already review their emergency preparedness communication 
plans periodically. Thus, complying with this requirement would 
constitute a usual and customary business practice and would not be 
subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Therefore, we 
have not assigned a burden.
    Proposed Sec.  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 Sec.  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

[[Page 79120]]

documentation of the training. Thereafter, the RNHCI would have to 
provide training at least annually. Based on our experience, all RNHCIs 
have some type of emergency preparedness training program. However, all 
RNHCIs would need to compare their current emergency preparedness 
training programs to their risk assessments and updated emergency 
preparedness plans, policies and procedures, and communication plans 
and revise or, if necessary, develop new sections for their training 
programs.
    We expect that complying with these requirements would require the 
involvement of the RNHCI administrator and the director of nursing. We 
estimate that it would require 7 burden hours for each RNHCI to develop 
an emergency training program at a cost of $218. Thus, it would require 
an estimated 112 burden hours (7 burden hours for each RNHCI x 16 
RNHCIs = 112 burden hours) at a cost of $3,488 ($218 estimated cost for 
each RNHCI x 16 RNHCI = $3,488 estimated cost).
    We are proposing that RNHCIs also review and update their emergency 
preparedness training and testing programs at least annually. Based on 
our experience with Medicare providers and suppliers, health care 
facilities generally have a compliance officer or other staff member 
who periodically reviews the facility's program to ensure that it 
complies with all relevant federal, state, and local laws, regulations, 
and ordinances. While this requirement is subject to the PRA, we expect 
that complying with this requirement would constitute a usual and 
customary business practice as defined at 5 CFR 1320.3(b)(2). 
Therefore, we have not calculated an estimate of the burden.
    Proposed Sec.  403.748(d)(2) would require RNHCIs to conduct a 
paper-based, tabletop exercise at least annually. The RNHCI must also 
analyze its response to and maintain documentation of all tabletop 
exercises and emergency events, and revise its emergency plan, as 
needed.
    The burden associated with complying with this requirement would be 
the resources RNHCIs would need to develop the scenarios for the 
exercises and the necessary documentation. Based on our experience with 
RNHCIs, RNHCIs already conduct some type of exercise periodically to 
test their emergency preparedness plans. However, we expect that RNHCIs 
would not be fully compliant with our proposed requirements. We expect 
that the director of nursing would develop the scenarios and required 
documentation. We estimate that these tasks would require 3 burden 
hours at a cost of $72 for each RNCHI. Based on this estimate, for all 
16 RNHCIs to comply with these requirements would require 48 burden 
hours (3 burden hours for each RNHCI x 16 RNHCIs = 48 burden hours) at 
a cost of $1,152 ($72 estimated cost for each RNHCI x 16 RNHCI = $1,152 
estimated cost).

    Table 2--Burden Hours and Cost Estimates for All 16 RNHCIS To Comply With the ICRs Contained in Sec.   403.748 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                          Burden per     Total      labor cost  Total labor  Total capital/
    Regulation section(s)     OMB Control No.   Number of    Number of     response      annual         of        cost of      maintenance    Total cost
                                               respondents   responses     (hours)       burden     reporting    reporting      costs ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   403.748(a)(1)........  0938--New......           16           16            9          144           **        4,240               0        4,240
Sec.   403.748(a)(1)--(4)...  0938--New......           16           16           12          192           **        5,568               0        5,568
Sec.   403.748(b)...........  0938--New......           16           16            6           96           **        2,624               0        2,624
Sec.   403.748(c)...........  0938--New......           16           16            4           64           **        1,856               0        1,856
Sec.   403.748(d)(1)........  0938--New......           16           16            7          112           **        3,488               0        3,488
Sec.   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 (Sec.  
416.54)

    Proposed Sec.  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 Sec.  416.54(a)(1) through (4).
    We will discuss the burden for these activities individually below 
beginning with the risk assessment requirement in Sec.  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 non-accredited and 1,568 
are accredited. Of the 1,568 accredited ASCs, we estimate that 350 are 
accredited by The Joint Commission (TJC), 876 by the AAAHC, and 
additional facilities are accredited by the AOA or the AAAASF. The 
accreditation standards for these organizations vary in their 
requirements related to emergency preparedness. The AOA's standards are 
very similar to the current ASC regulations. AAAASF does have some 
emergency preparedness requirements, such as requirements for responses 
or written protocols for security emergencies, for example, intruders 
and other threats to staff or patients; power failures; transferring 
patients; and emergency evacuation of the facility. However, the 
accreditation standards for both the AOA and AAAASF would not 
significantly satisfy the ICRs contained in this proposed rule. 
Therefore, for the purpose of determining the burden imposed on ASCs by 
this proposed rule, we will include the ASCs that are accredited by 
both the AOA and AAAASF with the non-accredited ASCs.
    TJC and AAAHC's accreditation standards contain more extensive 
emergency preparedness requirements than the accreditation standards of 
either AOA or AAAASF. For example, TJC standards contain requirements 
for risk assessments and an emergency management plan. AAAHC's 
standards include requirements for both internal and external 
emergencies and drills for the facility's internal emergency plan.

[[Page 79121]]

Therefore, in discussing the individual burden requirements in this 
proposed rule, we will discuss the burden for the estimated 1,226 
accredited ASCs by either the AAHC or TJC (876 AAAHC-accredited ASCs + 
350 TJC-accredited ASCs = 1,226 ASCs accredited by TJC or AAAHC) 
separately from the 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 Sec.  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 AAAHC-accredited ASCs have performed some type of risk 
assessment. However, we do not expect that this would satisfy the 
requirement for a documented, facility-based and community-based risk 
assessment that addressed the elements required for the emergency plan. 
Therefore, the 876 AAAHC-accredited ASCs would be included in the 
burden analysis with the ASCs that are non-accredited or are accredited 
by AOA and AAAASF for the risk assessment requirement for 5,004 non 
TJC-accredited ASCs (5,354 total ASCs-350 TJC-accredited ASCs = 5,004 
non TJC-accredited ASCs).
    We expect that all ASCs have already performed at least some of the 
work needed for a risk assessment. However, many probably have not 
performed a thorough risk assessment. Therefore, we expect that all non 
TJC-accredited ASCs would perform thorough reviews of their current 
risk assessments, if they have them, and revise them to ensure they 
have updated the assessments and that they have included all of the 
requirements in proposed Sec.  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 x 5,004 
non TJC-accredited ASCs = 40,032 burden hours) for all non TJC-
accredited ASCs to comply with this risk assessment requirement at a 
cost of $2,386,908 ($477 estimated cost for each ASC x 5,004 ASCs = 
$2,386,908 estimated cost).
    After conducting the risk assessment, ASCs would be required to 
develop and maintain emergency preparedness plans in accordance with 
Sec.  416.54(a)(1) through (4). All TJC-accredited ASCs must already 
comply with many of the requirements in proposed Sec.  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 TJC-accredited ASCs, 
this requirement would constitute a usual and customary business 
practice for these ASCs in accordance with 5 CFR 1320.3(b)(2). 
Therefore, we will not include this activity in the burden analysis for 
those ASCs.
    AAAHC-accredited ASCs are required to have a ``comprehensive 
emergency plan to address internal and external emergencies'' (AHAC, 
Chapter 8. Facilities and Environment, Element D, p. 37). However, we 
do not believe that this requirement ensures compliance with all of the 
requirements for an emergency plan. We will include the 876 AAAAHC-
accredited ASCs in the burden analysis for this requirement.
    We expect that the 5,004 non TJC-accredited ASCs have developed 
some type of emergency preparedness plan. However, under this proposed 
rule, all of these ASCs would have to review their current plans and 
compare them to the risk assessments they performed in accordance with 
proposed Sec.  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

[[Page 79122]]

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 Sec.  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 TJC-accredited ASC x 
5,004 non TJC-accredited ASCs = 55,044 burden hours) at a cost of 
$3,267,612 ($653 estimated cost for each non TJC-accredited ASC x 5,004 
non TJC-accredited ASCs = $3,267,612).
    All of the ASCs would also be required to review and update their 
emergency preparedness plans at least annually. For the purpose of 
determining the burden for this requirement, we would expect that ASCs 
would review their plans annually. All ASCs have a professional staff 
person, generally a quality improvement nurse, whose responsibility 
entails ensuring that the ASC is delivering quality patient care and 
that the ASC is complying with regulations concerning patient care. We 
expect that the quality improvement nurse would be primarily 
responsible for the annual review of the ASC's emergency preparedness 
plan. We expect that complying with this requirement would constitute a 
usual and customary business practice for ASCs in accordance with 5 CFR 
1320.3(b)(2). Therefore, we will not include this activity in the 
burden analysis.
    Section 416.54(b) proposes that each ASC be required to develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, the risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan set forth in paragraphs (c) of this section. We would require ASCs 
to review and update these policies and procedures at least annually. 
These policies and procedures would be required to include, at a 
minimum, the requirements listed at Sec.  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), TJC-accredited ASCs are 
required to ``develop policies and procedures that guide and support 
patient care, treatment, and services'' (CAMAC, Standard LD.3.90, EP 1, 
p. LD-12a). In addition, TJC-accredited ASCs must already address or 
perform a HVA; processes for communicating with and assigning staff 
under emergency conditions; provision of subsistence or critical needs; 
evacuation of the facility; and alternate sources for fuel, water, 
electricity, etc. (CAMAC, Standard EC.4.10, EPs 1, 7-10, 12, and 20, 
pp. EC-12-13). They must also critique their drills and modify their 
emergency management plans in response to the critiques (CAMAC, 
Standard EC.4.20, EPs 12-16, pp. EC-14-14a). In the chapter entitled, 
``Management of Information'' (IM), they are required to protect and 
preserve the privacy and confidentiality of sensitive data (CAMAC, 
Standard IM.2.10, EPs 1 and 9, p. IM-6). If TJC-accredited ASCs have 
any tasks required to satisfy these requirements, we expect they would 
constitute only a negligible burden. For the 350 TJC-accredited ASCs, 
the requirement for emergency preparedness policies and procedures 
would constitute a usual and customary business practice in accordance 
with 5 CFR 1320.3(b)(2). Therefore, we will not include this activity 
in the burden analysis for these 350 TJC-accredited ASCs.
    AAAHC standards require ASCs to have ``the necessary personnel, 
equipment and procedures to handle medical and other emergencies that 
may arise in connection with services 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 Sec.  416.54(b).
    We expect that all of the 5,004 non TJC-accredited ASCs have some 
emergency preparedness policies and procedures. However, we expect that 
all of these ASCs would need to review their policies and procedures 
and revise their policies and procedures to ensure that they address 
all of the proposed requirements. We expect that the quality 
improvement nurse would initially review the ASC's emergency 
preparedness policies and procedures. The quality improvement nurse 
would send any recommendations for changes or additional policies or 
procedures to the ASC's administrator. The administrator and quality 
improvement nurse would need to make the necessary revisions and draft 
any necessary policies and procedures. We estimate that for each non 
TJC-accredited ASC to comply with this proposed requirement would 
require 9 burden hours at a cost of $505. For all 5,004 ASCs to comply 
with this requirement would require an estimated 45,036 burden hours (9 
burden hours for each non TJC-accredited ASC x 5,004 non TJC-accredited 
ASCs = 45,036) at a cost of $2,527,020. ($505 estimated cost for each 
non TJC-accredited ASC x 5,004 ASCs = $2,527,020 estimated cost).
    Proposed Sec.  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 Sec.  
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

[[Page 79123]]

(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 AAAHC-accredited ASCs in with the non-accredited ASCs 
in determining the burden for these requirements for a total of 5,004 
non TJC-accredited ASCs (5,354 total ASCs--350 TJC accredited ASCs).
    We expect that all non TJC-accredited ASCs currently have some type 
of emergency preparedness communication plan. It is standard practice 
in the health care industry to have and maintain contact information 
for both staff and outside sources of assistance; alternate means of 
communications in case there is an interruption in phone service to the 
facility, such as cell phones; and a method for sharing information and 
medical documentation with other health care providers to ensure 
continuity of care for their patients. We expect that all ASCs already 
satisfy the requirements in proposed Sec.  416.54(c)(1) through (4). 
However, for the requirements in proposed Sec.  416.54(c)(5) through 
(7), all ASCs would need to review, revise, and, if necessary, develop 
new sections for their plans to ensure that they include all of the 
proposed requirements. We expect that this would require the 
involvement of the ASC's administrator and a quality improvement nurse. 
We estimate that complying with this proposed requirement would require 
4 burden hours at a cost of $227. Therefore, for all non TJC-accredited 
ASCs to comply with the requirements in this section would require an 
estimated 20,016 burden hours (4 hours for each non TJC-accredited ASC 
x 5,004 non TJC-accredited ASCs = 20,016 burden hours) at a cost of 
$1,135,908 ($227 estimated cost for each non TJC-accredited ASC x 5,004 
non TJC-accredited ASCs = $1,135,908 estimated cost).
    We also propose that ASCs must review and update their emergency 
preparedness communication plans at least annually. We believe that 
ASCs already review their emergency 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 Sec.  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 Sec.  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 Sec.  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 TJC-accredited 
ASCs are already fulfilling all of the proposed requirements, and we 
expect that the TJC-accredited ASCs will incur a burden complying with 
these requirements. Therefore, we will include these TJC-accredited 
ASCs in determining the burden for these requirements.
    The AAAHC-accredited ASCs are already required to ensure that ``all 
health care professionals have the necessary and appropriate training 
and skills to deliver the services provided by the organization'' 
(AAAHC, Chapter 4. Quality of Care Provided, Element A, p. 28). Since 
these ASCs are required to have an emergency plan that addresses 
internal and external emergencies, we expect that all of the AAAHC-
accredited ASCs already are providing some training on their emergency 
preparedness policies and procedures. However, this requirement does 
not include any requirement for annual training or for any training for 
staff that are not health care professionals. This AAAHC-accredited 
requirement does not ensure that these ASCs are already complying with 
the proposed requirements. Therefore, we will include these AAAHC-
accredited ASCs in determining the information collection burden for 
these requirements.
    Based upon our experience with ASCs, we expect that all 5,354 ASCs 
have some type of emergency preparedness training program. We also 
expect that these ASCs would need to review their training programs and 
compare them to their risk assessments, emergency preparedness plans, 
policies and procedures, and communication plans. The ASCs would then 
need to make any necessary revisions to their training programs to 
ensure they comply with these requirements. We expect that complying 
with this requirement would require the involvement of an administrator 
and a quality improvement nurse. We estimate that for each ASC to 
develop a comprehensive emergency training program would require 6 
burden hours at a cost of $329. Therefore, the estimated annual burden 
for all 5,354 ASCs to comply with these requirements is 32,124 burden 
hours (6

[[Page 79124]]

burden hours x 5,354 ASCs =32,124 burden hours) at a cost of $1,761,466 
($329 estimated cost for each ASC x 5,354 ASCs = $1,761,466 estimated 
cost).
    We propose that ASCs would also have to review and update their 
emergency preparedness training programs at least annually. For the 
purpose of determining the burden for this requirement, we would expect 
that ASCs would review their emergency preparedness training program 
annually. We expect that all ASCs have a quality improvement nurse 
responsible for ensuring that the ASC is delivering quality patient 
care and that the ASC is complying with patient care regulations. We 
expect that the quality improvement nurse would be primarily 
responsible for the annual review of the ASC's emergency preparedness 
training program. Thus, complying with this requirement would 
constitute a usual and customary business practice for ASCs in 
accordance with 5 CFR 1320.3(b)(2). Thus, we will not include this 
activity in this burden analysis.
    Proposed Sec.  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 TJC-accredited 
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 paper-based, tabletop exercise and the documentation necessary to 
record and analyze these events, as well as any emergency events. 
Although we believe many ASCs may have developed scenarios and 
documentation for whatever type of drills or exercises they had 
previously performed, we expect all ASCs would need to ensure that the 
testing of their emergency preparedness plans comply with these 
requirements. Based upon our experience with ASCs, we expect that 
complying with this requirement would require the involvement of an 
administrator and a quality improvement nurse. We estimate that for 
each ASC to comply would require 5 burden hours at a cost of $278. 
Therefore, for all 5,354 ASCs to comply with this requirement would 
require an estimated 26,770 burden hours (5 burden hours for each ASC x 
5,354 ASCs = 26,770 burden hours) at a cost of $1,488,412 ($278 
estimated cost for each ASC x 5,354 ASCs = $1,488,412 estimated cost).

    Table 3--Burden Hours and Cost Estimates for All 5,354 ASCs To Comply With the ICRs Contained in Sec.   416.54 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                          Burden per     Total      labor cost  Total labor  Total capital/
    Regulation section(s)     OMB Control No.  Respondents   Responses     response      annual         of        cost of      maintenance    Total cost
                                                                           (hours)       burden     reporting    reporting      costs ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   416.54(a)(1).........  0938--New......        5,004        5,004            8       40,032           **    2,386,908               0    2,386,908
Sec.   416.54(a)(1)-(4).....  0938--New......        5,004        5,004           11       55,044           **    3,267,612               0    3,267,612
Sec.   416.54(b)............  0938--New......        5,004        5,004            9       45,036           **    2,527,020               0    2,527,020
Sec.   416.54(c)............  0938--New......        5,004        5,004            4       20,016           **    1,135,908               0    1,135,908
Sec.   416.54(d)(1).........  0938--New......        5,354        5,354            6       32,124           **    1,758,176               0    1,758,176
Sec.   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 
(Sec.  418.113)

    Proposed Sec.  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 Sec.  418.113(a)(1) through (4).
    Although proposed Sec.  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 Sec.  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

[[Page 79125]]

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 Sec.  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 x 1,189 inpatient hospices 11,890 burden 
hours) for all inpatient hospices to comply with this requirement at a 
cost of $589,744 ($496 estimated cost for each inpatient hospice x 
1,189 inpatient hospices = $589,744 estimated cost).
    There are no emergency preparedness requirements in the current 
hospice CoPs for hospices that provide care to patients in their homes. 
However, it is standard practice for health care facilities to plan and 
prepare for common emergencies, such as fires, power outages, and 
storms. Although we expect that these hospices have considered at least 
some of the risks they might experience, we anticipate that these 
facilities would require more time than an inpatient hospice to perform 
a risk assessment. We estimate that each hospice that provides care to 
patients in their homes would require 12 burden hours to develop its 
risk assessment at a cost of $593. Therefore, based on that estimate, 
for all 2,584 hospices that provide care to patients in their homes, it 
would require 31,008 burden hours (12 burden hours for each hospice x 
2,584 hospices = 31,008 burden hours) to comply with this requirement 
at a cost of $1,532,312 ($593 estimated cost for each hospice x 2,584 
hospices = $1,532,312 estimated cost). Based on the previous 
calculations, we estimate that for all 3,773 hospices to develop a risk 
assessment would require 42,898 burden hours at a cost of $2,122,056.
    After conducting the risk assessments, hospices would have to 
develop and maintain emergency preparedness plans that they would have 
to review and update at least annually. We expect all hospices to 
compare their current emergency plans, if they have them, to the risk 
assessments they performed in accordance with proposed Sec.  
418.113(a)(1). In addition, hospices would have to comply with the 
requirements in Sec.  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 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 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

[[Page 79126]]

that the administrator would probably coordinate the meetings, perform 
an initial review of the current emergency plan, provide a critique of 
the emergency plan, offer suggested revisions, coordinate comments, 
develop the new emergency plan, and ensure that the necessary parties 
approve the new emergency plan. We expect the administrator would 
probably spend more time reviewing and working on the emergency plan 
than the other individuals. We estimate that it would require 14 burden 
hours for each inpatient hospice to develop its emergency preparedness 
plan at a cost of $742. Based on this estimate, it would require 16,646 
burden hours (14 burden hours for each inpatient hospice x 1,189 
inpatient hospices = 16,646 burden hours) for all inpatient hospices to 
complete their plans at a cost of $882,238 ($742 estimated cost for 
each inpatient hospice x 1,189 inpatient hospices = $882,238 estimated 
cost).
    As discussed earlier, we have no current regulatory requirement for 
hospices that provide care to patients in their homes to have emergency 
preparedness plans. However, it is standard practice for health care 
providers to plan for common emergencies, such as fires, power outages, 
and storms. Although we expect that these hospices already have some 
type of emergency or disaster plan, each hospice would need to review 
its emergency plan to ensure that it addressed the risks identified in 
its risk assessment and complied with the proposed requirements. We 
expect that an administrator and the individuals from the hospice's IDG 
would be involved in reviewing, revising, and developing a facility's 
emergency plan. However, since there are no current requirements for 
hospices that provide care to patients in their homes have emergency 
plans, we believe it would require more time for each of these hospices 
than for inpatient hospices to complete an emergency plan. We estimate 
that for each hospice that provides care to patients in their homes to 
comply with this proposed requirement would require 20 burden hours at 
an estimated cost of $1,046. Based on that estimate, for all 2,584 of 
these hospices to comply with this requirement would require 51,680 
burden hours (20 burden hours for each hospice x 2,584 hospices = 
51,680 burden hours) at a cost of $2,702,864 ($1,046 estimated cost for 
each hospice x 2,584 hospices = $2,702,864 estimated cost). We estimate 
that for all 3,773 hospices to develop an emergency preparedness plan 
would require 68,326 burden hours at a cost of $3,585,102.
    Hospices would also be required to review and update their 
emergency preparedness plans at least annually. The current hospice 
CoPs require inpatient hospices to periodically review and rehearse 
their disaster preparedness plan with their staff, including non-
employee 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 Sec.  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 Sec.  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 x 
1,189 inpatient hospices = 9,512 burden hours) at a cost of $474,411 
($399 estimated cost for each inpatient hospice x 1,189 inpatient 
hospices = $474,411 estimated cost).
    Although there are no existing regulatory requirements for hospices 
that provide care to patients in their homes to have emergency 
preparedness policies and procedures, it is standard practice for 
health care organizations to prepare for common emergencies, such as 
fires, power outages, and storms. We expect that these hospices already 
have some emergency preparedness policies and procedures. However, 
under this proposed rule, the IDG for these hospices would need to 
accomplish the same tasks as described earlier for inpatient hospices 
to ensure that these policies and procedures comply with the proposed 
requirements.
    We estimate that each hospice's compliance with this requirement 
would require 9 burden hours at a cost of $454. Therefore, based on 
that estimate, all 2,584 hospices' that provide care to patients in 
their homes to comply with this requirement would require 23,256 burden 
hours (9 burden hours for each hospice x 2,584 hospices = 23,256 burden 
hours) at a cost of $1,173,136 ($454 estimated cost for each hospice x 
2,584 hospices = $1,173,136 estimated cost).
    Thus, we estimate that development of emergency preparedness 
policies and procedures for all 3,773 hospices would

[[Page 79127]]

require 32,768 burden hours at a cost of $1,647,547.
    Proposed Sec.  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 Sec.  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 x 3,773 hospices = 11,319 burden hours) at a cost of 
$622,545 ($165 estimated cost for each hospice x 3,773 hospices = 
$622,545 estimated cost).
    We are proposing that a hospice review and update its emergency 
preparedness communication plan at least annually. We believe that all 
hospices already review their emergency preparedness communication 
plans periodically. Thus, compliance with this requirement would 
constitute a usual and customary business practice for hospices and 
would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  
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 (Sec.  418.100(g)(2) and (3)). They must 
also provide employee orientation and training consistent with hospice 
industry standards (42 CFR 418.78(a)). In addition, inpatient hospices 
must periodically review and rehearse their disaster preparedness plans 
with their staff, including non-employee staff (42 CFR 
418.110(c)(1)(ii)). We expect that all hospices already provide 
training to their employees on the facility's existing disaster plans, 
policies, and procedures. However, under this proposed rule, all 
hospices would need to review their current training programs and 
compare their contents to their updated emergency preparedness plans, 
policies and procedures, and communications plans. Hospices would then 
need to review, revise, and in some cases, develop new material for 
their training programs so that they complied with these requirements.
    The burden associated with the aforementioned requirements would be 
the time and effort necessary for a hospice to bring itself into 
compliance with the requirements in this section. We expect that 
compliance with this requirement would require the involvement of a 
registered nurse. We expect that the registered nurse would compare the 
hospice's current training program with the facility's emergency 
preparedness plan, policies and procedures, and communication plan, and 
then make any necessary revisions, including the development of new 
training material, as needed. We estimate that these tasks would 
require 6 burden hours at a cost of $252. Based on this estimate, 
compliance by all 3,773 hospices would require 22,638 burden hours (6 
burden hours for each hospice x 3,773 hospices = 22,638 burden hours) 
at a cost of $950,796 ($252 estimated cost for each hospice x 3,773 
hospices = $950,796 estimated cost).
    We are proposing that hospices also be required to review and 
update their emergency preparedness training programs at least 
annually. We believe that hospices already review their emergency 
preparedness training programs periodically. Therefore, compliance with 
this requirement would constitute a usual and customary business 
practice for hospices and would not be subject to the PRA in accordance 
with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 (Sec.  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

[[Page 79128]]

requirements would require the involvement of a registered nurse. We 
expect that the registered nurse would develop the necessary 
documentation and the scenarios for the drills and exercises. We 
estimate that these tasks would require 4 burden hours at an estimated 
cost of $168. Based on this estimate, in order for all 3,773 hospices 
to comply with these requirements, it would require 15,092 burden hours 
(4 burden hours for each hospice x 3,773 hospices = 15,092 burden 
hours) at a cost of $633,864 ($168 estimated cost for each hospice x 
3,773 hospices = $633,864 estimated cost).
    Thus, for all 3,773 hospices to comply with all of the requirements 
in Sec.  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 Sec.   418.113 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                         Burden  per     Total      labor cost  Total labor  Total capital/
    Regulation section(s)     OMB Control No.  Respondents   Responses     response      annual         of        cost of      maintenance    Total cost
                                                                           (hours)       burden     reporting    reporting      costs ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   418.113(a)(1)          0938--New......        1,189        1,189           10       11,890  ...........      589,744  ..............      589,744
 (inpatient).
Sec.   418.113(a)(1)          0938--New......        2,584        2,584           12       31,008  ...........    1,532,312  ..............    1,532,312
 (outpatient).
Sec.   418.113(a)(1)-(4)      0938--New......        1,189        1,189           14       16,646  ...........      882,238  ..............      882,238
 (inpatient).
Sec.   418.113(a)(1)-(4)      0938--New......        2,584        2,584           20       51,680  ...........    2,702,864  ..............    2,702,864
 (outpatient).
Sec.   418.113(b)             0938--New......        1,189        1,189            8        9,512  ...........      474,411  ..............      474,411
 (inpatient).
Sec.   418.113(b)             0938--New......        2,584        2,584            9       23,256  ...........    1,173,136  ..............    1,173,136
 (outpatient).
Sec.   418.113(c)...........  0938--New......        3,773        3,773            3       11,319  ...........      622,545  ..............      622,545
Sec.   418.113(d)(1)........  0938--New......        3,773        3,773            6       22,638  ...........      950,796  ..............      950,796
Sec.   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 (Sec.  441.184)

    Proposed Sec.  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 Sec.  
441.184(a)(1) through (4).
    Section Sec.  441.184(a)(1) would require each PRTF to develop a 
documented, facility-based and community-based risk assessment that 
would utilize an all-hazards approach. We expect that all PRTFs have 
already performed some of the work needed for a risk assessment because 
it is standard practice for health care facilities to prepare for 
common hazards, such as fires and power outages, and disasters or 
emergencies common in their geographic area, such as snowstorms or 
hurricanes. However, many PRTFs may not have documented their risk 
assessments or performed one that would comply with all of our proposed 
requirements. Therefore, we expect that all PRTFs would have to review 
and revise their current risk assessments.
    We have not designated any specific process or format for PRTFs to 
use in conducting their risk assessments because we believe that PRTFs 
need maximum flexibility to determine the best way to accomplish this 
task. However, we expect that PRTFs would include representation from 
or seek input from all of their major departments. Based on our 
experience with PRTFs, we expect that conducting the risk assessment 
would require the involvement of the PRTF's administrator, a 
psychiatric registered nurse, and a clinical social worker. We expect 
that all of these individuals would attend an initial meeting, review 
their current assessment, develop comments and recommendations for 
changes, attend a follow-up meeting, perform a final review, and 
approve the new risk assessment. We expect that the psychiatric 
registered nurse would coordinate the meetings, perform an initial 
review, offer suggested revisions, coordinate comments, develop a new 
risk assessment, and ensure that the necessary parties approve the new 
risk assessment. We also expect that the psychiatric registered nurse 
would spend more time reviewing and working on the risk assessment than 
the other individuals. We estimate that in order for each PRTF to 
comply, it would require 8 burden hours at a cost of $394. There are 
currently 387 PRTFs. Therefore, based on that estimate, compliance by 
all PRTFs would require 3,096 burden hours (8 burden hours for each 
PRTF x 387 PRTFs = 3,096 burden hours) at a cost of $152,478 ($394 
estimated cost for each PRTF x 387 PRTFs = $152,478 estimated cost).
    After conducting the risk assessment, Sec.  441.184(a)(1) through 
(4) would require PRTFs to develop and maintain an emergency 
preparedness plan. Although it is standard practice for health care 
facilities to have some type of emergency preparedness plan, all PRTFs 
would need to review their current plans and compare them to their risk 
assessments. Each PRTF would need to update, revise, and, in some 
cases, develop new sections to complete its emergency preparedness 
plan.
    Based upon our experience with PRTFs, we expect that the 
administrator and psychiatric registered nurse who were involved in 
developing the risk assessment would be involved in developing the 
emergency preparedness plan. However, we expect it would require 
substantially more time to complete the plan than the risk assessment. 
We expect that the psychiatric nurse would be the most heavily involved 
in reviewing and developing the PRTF's emergency preparedness plan. We 
also expect that a clinical social worker would review the drafts of 
the plan and provide comments on it to the psychiatric registered 
nurse. We estimate that for each PRTF to comply with this requirement 
would require 12 burden hours at a cost of $634. Thus, we estimate that 
it would require 4,644 burden hours (12 burden hours for each PRTF x 
387 PRTFs = 4,644 burden hours) for all PRTFs to comply with this 
requirement at a cost of $245,358 ($634 estimated cost per PRTF x 387 
PRTFs = $245,358 estimated cost).
    PRTFs also would be required to review and update their emergency 
preparedness plans at least annually. We believe that PRTFs are already 
reviewing their emergency preparedness plans periodically. Thus, 
compliance with this requirement would constitute a usual and customary 
business practice for PRTFs and would not be subject to the PRA in 
accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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

[[Page 79129]]

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 Sec.  
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 Sec.  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 x 387 PRTFs = 3,483 
burden hours) for all PRTFs to comply with this requirement at a cost 
of $192,726 ($498 estimated cost per PRTF x 387 PRTFs = $192,726 
estimated cost).
    We are also proposing that PRTFs review and update their emergency 
preparedness policies and procedures at least annually. We believe that 
PRTFs are already reviewing their emergency preparedness policies and 
procedures periodically. Therefore, compliance with this requirement 
would constitute a usual and customary business practice for PRTFs and 
would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  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 x 387 PRTFs = 1,935 burden hours) at a cost of $110,682 
($286 estimated cost for each PRTF x 387 PRTFs = $110,682 estimated 
cost).
    PRTFs must also review and update their emergency preparedness 
communication plans at least annually. We believe that PRTFs are 
already reviewing their emergency preparedness communication plans 
periodically. Thus, compliance with this requirement would constitute a 
usual and customary business practice for PRTFs and would not be 
subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  441.184(d) would require PRTFs to develop and 
maintain emergency preparedness training programs and review and update 
those programs at least annually. Proposed Sec.  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 x 387 PRTFs = 3,870 burden hours) at a cost of $178,020 ($460 
estimated cost for each PRTF x 387 PRTFs = $178,020 estimated cost).
    PRTFs would also be required to review and update their emergency 
preparedness training program at least annually. We believe that PRTFs 
are already reviewing their emergency preparedness training programs 
periodically. Therefore, compliance with this requirement would 
constitute a usual and customary business practice for PRTFs and would 
not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  441.184(d)(2) would require PRTFs to participate in 
a community mock disaster drill, and if one were not available, conduct 
an individual, facility-based mock disaster drill, and a paper-based, 
tabletop exercise at least annually. PRTFs would also have to analyze 
their responses to and maintain documentation of all drills, tabletop 
exercises, and emergency events, and revise their emergency plans, as 
needed. However, if a PRTF experienced an actual natural or man-made 
emergency that required activation of its emergency plan, that PRTF 
would be exempt from engaging in a community or an individual, 
facility-based mock disaster drill for 1 year following the onset of 
the actual emergency event. To comply with this requirement, 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,

[[Page 79130]]

and emergency events. However, we do not expect that all PRTFs are 
conducting both a drill and a paper-based, tabletop exercise annually 
or have developed the appropriate documentation. Thus, we will analyze 
the burden of these requirements for all PRTFs.
    Based on our experience with PRTFs, we expect that the same 
individual who developed the emergency preparedness training program 
would develop the scenarios for the drill and the exercise and the 
accompanying documentation. We estimate that for each PRTF to comply 
with the requirements in this section would require 3 burden hours at a 
cost of $138. We estimate that for all PRTFs to comply would require 
1,161 burden hours (3 burden hours for each PRTF x 387 PRTFs = 1,161 
burden hours) at a cost of $53,406 ($138 estimated cost for each PRTF x 
387 PRTFs = $53,406 estimated cost).
    Based on the previous analysis, for all 387 PRTFs to comply with 
the ICRs in this proposed rule would require 18,189 burden hours at a 
cost of $932,670.

    Table 5--Burden Hours and Cost Estimates for All 387 PRTFs To Comply With the ICRs Contained in Sec.   441.184 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                         Burden  per     Total     labor  cost  Total labor  Total  capital/
    Regulation section(s)     OMB Control No.  Respondents   Responses     response      annual         of        cost of      maintenance   Total  cost
                                                                           (hours)       burden     reporting    reporting      costs ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   441.184(a)(1)........  0938--New......          387          387            8        3,096           **      152,478               0      152,478
Sec.   441.184(a)(1)-(4)....  0938--New......          387          387           12        4,644           **      245,358               0      245,358
Sec.   441.184(b)...........  0938--New......          387          387            9        3,483           **      192,726               0      192,726
Sec.   441.184(c)...........  0938--New......          387          387            5        1,935           **      110,682               0      110,682
Sec.   441.184(d)(1)........  0938--New......          387          387           10        3,870           **      178,020               0      178,020
Sec.   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 (Sec.  460.84)

    Proposed Sec.  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 Sec.  460.84(a)(1) through (4).
    Section Sec.  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 (Sec.  
460.72(c)(1)). The definition of ``emergencies'' includes natural 
disasters that are likely to occur in the PACE organization's area 
(Sec.  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 x 91 PACE organizations = 1,274 burden hours) at a cost of 
$69,251 ($761 estimated cost for each PACE organization x 91 PACE 
organizations = $69,251 estimated cost).
    After conducting a risk assessment, PACE organizations would have 
to develop and maintain emergency preparedness plans that satisfied all 
of the requirements in Sec.  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 (Sec.  460.62(a)(6)). We 
expect that an emergency preparedness plan would be

[[Page 79131]]

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 x 91 PACE organizations = 2,093 burden hours) at a 
cost of $112,749 ($1,239 estimated cost for each PACE organization x 91 
PACE organizations = $112,749 estimated cost).
    PACE organizations would also be required to review and update 
their emergency preparedness plans at least annually. We believe that 
PACE organizations are already reviewing their emergency preparedness 
plans periodically. Therefore, compliance with this requirement would 
constitute a usual and customary business practice for PACE 
organizations and would not be subject to the PRA in accordance with 5 
CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  460.84(b)(1) through (9).
    Current regulations already require that PACE organizations 
establish, implement, and maintain procedures for managing emergencies 
and disasters (Sec.  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 (Sec.  
460.62(a)(6)). Thus, we expect that all PACE organizations have some 
emergency preparedness policies and procedures. However, these 
requirements do not ensure that all PACE organizations have policies 
and procedures that would comply with our proposed requirements.
    The burden associated with the proposed requirements would be the 
resources needed to review, revise, and, if needed, develop new 
emergency preparedness policies and procedures. We expect that the 
program director, home care coordinator, and quality improvement nurse 
would be primarily responsible for reviewing, revising, and if needed, 
developing any new policies and procedures needed to comply with our 
proposed requirements. We estimate that for each PACE organization to 
comply with our proposed requirements would require 12 burden hours at 
a cost of $598. Therefore, based on this estimate, for all PACE 
organizations to comply would require 1,092 burden hours (12 burden 
hours for each PACE organization x 91 PACE organizations = 1,092 burden 
hours) at a cost of $54,418 ($598 estimated cost for each PACE 
organization x 91 PACE organizations = $54,418 estimated cost).
    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 Sec.  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 Sec.  
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 (Sec.  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 x 91 PACE organizations = 637 burden hours) at a cost 
of $28,665 ($315 estimated cost for each PACE organization x 91 PACE 
organizations = $28,665 estimated cost).
    Each PACE organization must also review and update its emergency 
preparedness communication plan at least annually. We believe that PACE 
organizations are already reviewing and updating their emergency 
preparedness communication plans periodically.

[[Page 79132]]

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 Sec.  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 Sec.  460.84(d)(1) and (2).
    Proposed Sec.  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 (Sec.  460.72(c)(3)). However, these 
requirements do not ensure that all PACE organizations would be in 
compliance with our proposed requirements. Thus, each PACE organization 
would need to review its current training program and compare the 
training program to its risk assessment, emergency preparedness plan, 
policies and procedures, and communication plan. The PACE organization 
would also need to revise and, in some cases, develop new sections to 
ensure that its emergency preparedness training program complied with 
our proposed requirements. We expect that the quality assurance nurse 
would review all elements of the PACE organization's training program 
and determine what tasks would need to be performed and what materials 
would need to be developed to comply with our proposed requirements. We 
expect that the home care coordinator would work with the quality 
assurance nurse to develop the revised and updated training program. We 
estimate that for each PACE organization to comply with the proposed 
requirements would require 12 burden hours at a cost of $540. 
Therefore, it would require an estimated 1,092 burden hours (12 burden 
hours for each PACE organization x 91 PACE organizations = 1,092 burden 
hours) to comply with this requirement at a cost of $49,140 ($540 
estimated cost for each PACE organization x 91 PACE organizations = 
$49,140 estimated cost).
    PACE organizations would also be required to review and update 
their emergency preparedness training program at least annually. We 
believe that PACE organizations are already reviewing and updating 
their emergency preparedness training programs periodically. Therefore, 
compliance with this requirement would constitute a usual and customary 
business practice for PACE organizations and would not be subject to 
the PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  460.84(d)(2) would require PACE organizations to 
participate in a community mock disaster drill at least annually. If a 
community mock disaster drill was not available, the PACE organization 
would have to conduct an individual, facility-based mock disaster 
drill. They would also be required to conduct a paper-based, tabletop 
exercise at least annually. PACE organizations would also be required 
to analyze their responses to, and maintain documentation of, all 
drills, exercises, and any emergency events they experienced. If a PACE 
organization experienced an actual natural or man-made emergency that 
required activation of its emergency plan, it would be exempt from 
engaging in a community or individual, facility-based mock disaster 
drill for 1 year following the onset of the actual event. To comply 
with these requirements, PACE organizations would need to develop a 
specific scenario for each drill and exercise. The PACE organizations 
would also have to develop the documentation necessary for recording 
and analyzing their response to all drills, exercises, and emergency 
events.
    Current regulations require each PACE organization to conduct a 
test of its emergency and disaster plan at least annually (42 CFR 
460.72(c)(5)). They also must evaluate and document the effectiveness 
of their emergency and disaster plans. Thus, PACE organizations already 
conduct at least one test annually of their plans. We expect that as 
part of testing their emergency plans annually, PACE organizations 
would develop a scenario for and document the testing. However, this 
does not ensure that all PACE organizations would be in compliance with 
all of our proposed requirements, especially the proposed requirement 
for conducting a paper-based, tabletop exercise; performing a 
community-based mock disaster drill; and using different scenarios for 
the drill and the exercise.
    The 91 PACE organizations would be required to develop scenarios 
for a mock disaster drill and a paper-based, tabletop exercise and the 
documentation necessary to record and analyze their response to all 
drills, exercises, and any emergency events. Based on our experience 
with PACE organizations, we expect that the same individuals who 
developed their emergency preparedness training programs would develop 
the required documentation. We expect the quality improvement nurse 
would spend more time on these activities than the health care 
coordinator. We estimate that this activity would require 5 burden 
hours for each PACE organization at a cost of $225. We estimate that 
for all PACE organizations to comply with these requirements would 
require 455 burden hours (5 burden hours for each PACE organization x 
91 PACE organizations = 455 burden hours) at a cost of $20,475 ($225 
estimated cost for each PACE organization x 91 PACE organizations = 
$20,475 estimated cost).

    Table 6--Burden Hours and Cost Estimates for All 91 PACE Organizations to Comply With the ICRs Contained in Sec.   460.84 Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                          Burden per     Total      labor cost  Total labor  Total capital/
    Regulation section(s)     OMB Control No.  Respondents   Responses     response      annual         of        cost of      maintenance    Total cost
                                                                           (hours)       burden     reporting     eporting      costs ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   460.84(a)(1).........  0938--New......           91           91           14        1,274           **       69,251               0       69,251
Sec.   460.84(a)(1)-(4).....  0938--New......           91           91           23        2,093           **      112,749               0      112,749
Sec.   460.84(b)............  0938--New......           91           91           12        1,092           **       54,418               0       54,418
Sec.   460.84(c)............  0938--New......           91           91            7          637           **       28,665               0       28,665
Sec.   460.84(d)(1).........  0938--New......           91           91           12        1,092           **       49,140               0       49,140
Sec.   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.


[[Page 79133]]

H. ICRs Regarding Condition of Participation: Emergency Preparedness 
(Sec.  482.15)

    Proposed Sec.  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 Sec.  482.15(a)(1) 
through (4).
    Note that we obtain data on the number of hospitals, both 
accredited and non-accredited, from the CMS CASPER data system, which 
are updated periodically by the individual states. Due to variations in 
the timeliness of the data submissions, all numbers are approximate, 
and the number of accredited and non-accredited hospitals shown may not 
equal the number of hospitals at the time of this proposed rule's 
publication. In addition, some hospitals may have chosen to be 
accredited by more than one accrediting organization.
    There are approximately 4,928 Medicare-certified hospitals. This 
includes 107 critical access hospitals (CAHs) that have rehabilitation 
or psychiatric distinct part units (DPUs) as of March 27, 2013. The 
services provided by CAH psychiatric or rehabilitation DPUs must comply 
with the hospital Conditions of Participation (CoPs) (42 CFR 
485.647(a)). RNHCIs and CAHs that do not have DPUs have been excluded 
from this number and are addressed separately in this analysis. Of the 
4,928 hospitals reported in CMS' CASPER data system, approximately 
4,587 are accredited hospitals and the remainder is non-accredited 
hospitals. Three organizations have accrediting authority for these 
hospitals: TJC, formerly known as the Joint Commission on the 
Accreditation of Healthcare Organizations (JCAHO), the AOA, and DNVHC.
    Accreditation can substantially affect the burden a hospital would 
sustain under this proposed rule. The Joint Commission accredits 3,410 
hospitals. Many of our proposed requirements are similar or virtually 
identical to the standards, rationales, and elements of 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 DNVHC-accredited 
hospitals in with the hospitals that are not accredited. Therefore, 
unless indicated otherwise, we have analyzed the burden for the 3,410 
TJC-accredited hospitals separately from the remaining 1,518 non TJC-
accredited hospitals (4,928 hospitals--3,410 TJC-accredited hospitals = 
1,518 non TJC-accredited hospitals).
    We have used TJC's ``Comprehensive Accreditation Manual for 
Hospitals: The Official Handbook 2008 (CAMH)'' to determine the burden 
for TJC-accredited hospitals. In the chapter entitled, ``Management of 
the Environment of Care'' (EC), hospitals are required to plan for 
managing the consequences of emergencies (CAMH, Standard EC.4.11, CAMH 
Refreshed Core, January 2008, p. EC-13a). Individual standards have 
EPs, which provide the detailed and specific performance expectations, 
structures, and processes for each standard (CAMH, CAMH Refreshed Core, 
January 2008, p. HM-6). The EPs for Standard EC.4.11 require, among 
other things, that hospitals conduct a hazard vulnerability analysis 
(HVA) (CAMH, Standard EC.4.11, EP 2, CAMH Refreshed Core, January 2008, 
p. EC-13a). Performing an HVA would require a hospital to identify the 
events that could possibly affect demand for the hospital's services or 
the hospital's ability to provide services. A TJC-accredited hospital 
also must determine the likeliness of the identified risks occurring, 
as well as their consequences. Thus, we expect that 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 TJC-accredited 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 Sec.  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 TJC-
accredited hospitals have already performed at least some of the work 
needed for a risk assessment. The Niska and Burt article indicated that 
most hospitals already have plans for natural disasters. However, many 
may not have thoroughly documented this activity or performed as 
thorough a risk assessment as needed to comply with our proposed 
requirements.
    We have not designated any specific process or format for hospitals 
to use in conducting a risk assessment because we believe that 
hospitals need the flexibility to determine how best to accomplish this 
task. However, we expect that hospitals would obtain input from all of 
their major departments when performing a risk assessment. Based on our 
experience, we expect that conducting a risk assessment would require 
the involvement of at least a hospital administrator, the risk 
management director, the chief medical officer, the chief of surgery, 
the director of nursing, the pharmacy director, the facilities 
director, the health information services director, the safety 
director, the security manager, the community relations manager, the 
food services director, and administrative support staff. We expect 
that most of these individuals would attend an initial meeting, review 
relevant sections of their current risk assessment, prepare and send 
their comments to the risk management director, attend a follow-up 
meeting, perform a final review, and approve the new risk assessment.
    We expect that the risk management director would coordinate the 
meetings, review and comment on the current risk assessment, suggest 
revisions, coordinate comments, develop the new risk assessment, and 
ensure that the necessary parties approve it. We expect that the 
hospital administrator would spend more time reviewing the risk 
assessment than most of the other individuals.
    We estimate that the risk assessment would require 36 burden hours 
to complete at a cost of $2,923 for each non-TJC accredited hospital. 
There are approximately 1,518 non TJC-accredited hospitals. Therefore, 
it would require an estimated 54,648 burden hours (36 burden hours for 
each non TJC-accredited hospitals x 1,518 non TJC-accredited hospitals 
= 54,648 burden hours) for all non TJC-accredited hospitals to comply 
at a cost of $4,437,114 ($2,923 estimated cost for each non TJC-
hospital x 1,518 non TJC-accredited hospitals = $4,437,114 estimated 
cost).
    Proposed Sec.  482.15(a)(1) through (4) would require hospitals to 
develop and maintain emergency preparedness plans. We expect that all 
hospitals would compare their risk assessments to their emergency plans 
and revise and, if necessary, develop new sections for their plans. 
TJC-accredited hospitals must develop and maintain written Emergency 
Operations Plans (EOPs) (CAMH, Standard EC.4.12, EP 1, CAMH Refreshed 
Care, January 2008, p. EC-13b). The EOP should describe an ``all-

[[Page 79134]]

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 TJC-accredited hospitals 
have already developed and are maintaining EOPs that comply with the 
requirement for an emergency plan in this proposed rule. If a TJC-
accredited hospital needed to complete additional tasks to comply with 
the proposed requirement, we believe that the burden would be 
negligible. Therefore, for TJC-accredited hospitals, this requirement 
would constitute a usual and customary business practice and would not 
be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    We expect that most, if not all, non TJC-accredited hospitals 
already have some type of emergency preparedness plan. The Niska and 
Burt article noted that the majority of hospitals have plans for 
natural disasters; incendiary incidents; and biological, chemical, and 
radiological terrorism. In addition, all hospitals must already meet 
the requirements set out at 42 CFR 482.41, including emergency power, 
lighting, gas and water supply requirements as well as specified Life 
Safety Code provisions. However, those existing plans may not be fully 
compliant with our proposed requirements. Thus, it would be necessary 
for non TJC-accredited hospitals to review their current plans and 
compare them to their risk assessments and revise, update, or, in some 
cases, develop new sections for their emergency plans.
    Based on our experience with hospitals, we expect that the same 
individuals who were involved in developing the risk assessment would 
be involved in developing the emergency preparedness plan. However, we 
estimate that it would require substantially more time to complete an 
emergency preparedness plan. We estimate that complying with this 
requirement would require 62 burden hours at a cost of $5,085 for each 
non TJC-accredited hospital. There are approximately 1,518 non TJC-
accredited hospitals. Therefore, based on this estimate, it would 
require 94,116 burden hours for all non TJC-accredited hospitals (62 
burden hours for each non TJC-accredited hospitals x 1,518 non TJC-
accredited hospitals = 94,116 burden hours) to complete an emergency 
preparedness plan at a cost of $7,719,030 ($5,085 estimated cost for 
each non TJC-accredited hospital x 1,518 non TJC-accredited hospitals = 
$7,719,030 estimated cost).
    Under this proposed rule, a hospital also would be required to 
review and update its emergency preparedness plan at least annually. We 
believe that hospitals already review their emergency preparedness 
plans periodically. Therefore, compliance with this requirement would 
constitute a usual and customary business practice for hospitals and 
would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Under proposed Sec.  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 Sec.  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 TJC-
accredited hospital leaders to ``develop policies and procedures that 
guide and support patient care, treatment, and services'' (CAMH, 
Standard LC.3.90, EP 1, CAMH Refreshed Core, January 2008, p. LD-15). 
Thus, we expect that TJC-accredited hospitals already have some 
policies and procedures related to our proposed requirements. As 
discussed later, many of the requirements in proposed Sec.  482.15(b) 
has a corresponding requirement in the TJC hospital accreditation 
standards. Hence, we will discuss each proposed section individually.
    Proposed Sec.  482.15(b)(1) would require hospitals to have 
policies and procedures for the provision of subsistence needs for 
staff and patients, whether they evacuate or shelter in place. TJC-
accredited hospitals are required to make plans for obtaining and 
replenishing medical and non-medical supplies, including food, water, 
and fuel for generators and transportation vehicles (CAMH, Standard 
EC.4.14, EPs 1-8 and 10-11, p. EC-13d). In addition, hospitals must 
identify alternative means of providing electricity, water, fuel, and 
other essential utility needs in cases when their usual supply is 
disrupted or compromised (CAMH, Standard EC.4.17, EPs 1-5, p. EC-13f). 
Thus, we expect that TJC-accredited hospitals would be in compliance 
with our proposed provision of subsistence requirements in proposed 
Sec.  482.15(b)(1).
    Proposed Sec.  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. TJC-accredited 
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 Sec.  482.15(b)(2).
    Proposed Sec.  482.15(b)(3) would require hospitals to have 
policies and procedures for a plan for the safe evacuation from the 
hospital. TJC-accredited hospitals are required to make 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 Sec.  
482.15(b)(3) also would require hospitals to have ``primary and 
alternate means of communication with external sources of assistance.'' 
TJC-accredited 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

[[Page 79135]]

requirements in proposed Sec.  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 Sec.  482.15(b)(4) would require hospitals to have 
policies and procedures that address a means to shelter in place for 
patients, staff, and volunteers who remain at the facility. The 
rationale for CAMH Standard EC.4.18 states, ``a catastrophic emergency 
may result in the decision to keep all patients on the premises in the 
interest of safety'' (CAMH, Standard EC.4.18, p. EC-13f). We expect 
that TJC-accredited hospitals would be in compliance with our proposed 
shelter in place requirement in Sec.  482.15(b)(4).
    Proposed Sec.  482.15(b)(5) would require hospitals to have 
policies and procedures that address a system of medical documentation 
that preserves patient information, protects the confidentiality of 
patient information, and ensures that records are secure and readily 
available. The CAMH chapter entitled ``Management of Information'' 
requires TJC-accredited hospitals to have storage and retrieval systems 
for their clinical/service and hospital-specific information (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 
Sec.  482.15(b)(5).
    Proposed Sec.  482.15(b)(6) would require hospitals to have 
policies and procedures that address the use of volunteers in an 
emergency or other emergency staffing strategies, including the process 
and role for integration of state and federally-designated health care 
professionals to address surge needs during an emergency. TJC-
accredited hospitals must already define staff roles and 
responsibilities in their EOPs and ensure that they train their staffs 
for their assigned roles (CAMH, Standard EC.4.16, EPs 1 and 2, p. EC-
13e). The rationale for Standard EC.4.15 indicates that the ``hospital 
determines the type of access and movement to be allowed by . . . 
emergency volunteers . . . when emergency measures are initiated.'' In 
addition, in the chapter entitled ``Medical Staff'' (MS), hospitals 
``may grant disaster privileges to volunteers that are eligible to be 
licensed independent practitioners'' (CAMH, Standard MS.4.110, CAMH 
Refreshed Care, January 2008, p. MS-27). Finally, in the chapter 
entitled ``Management of Human Resources'' (HR), hospitals ``may assign 
disaster responsibilities to volunteer practitioners'' (CAMH, Standard 
HR.1.25, CAMH Refreshed Core, January 2008, p. HR-5). Although TJC 
accreditation requirements partially address our proposed requirements, 
we do not believe these requirements would ensure compliance with all 
requirements in proposed in Sec.  482.15(b)(6).
    Proposed Sec.  482.15(b)(7) would require hospitals to have 
policies and procedures that would address the development of 
arrangements with other hospitals or other providers to receive 
patients in the event of limitations or cessation of operations to 
ensure continuity of services to hospital patients. TJC-accredited 
hospitals must plan for the sharing of resources and assets with other 
health care organizations (CAMH, Standard EC.4.14, EPs 7 and 8, p. EC-
13d). However, we would not expect TJC-accredited hospitals to be 
substantially in compliance with the requirements we propose in Sec.  
482.15(b)(7) based on compliance with TJC accreditation standards 
alone.
    Proposed Sec.  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 
Sec.  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 Sec.  482.15(b)(8).
    In summary, we expect that TJC-accredited hospitals have developed 
and are maintaining policies and procedures that would comply with the 
requirements in proposed Sec.  482.15(b), except for proposed 
Sec. Sec.  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 TJC-accredited 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 Sec.  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 Sec.  482.15(b)(3), (b)(6), and 
(b)(7) would be the resources required to develop written policies and 
procedures that comply with the proposed requirements. We expect that 
the risk management director would review the hospital's policies and 
procedures initially and make recommendations for revisions and 
development of additional policies or procedures. We expect that 
representatives from the hospital's major departments would make 
revisions or draft new policies and procedures based on the 
administrator's recommendation. The appropriate parties would then need 
to compile and disseminate these new policies and procedures.
    We estimate that complying with these requirements would require 17 
burden hours for each TJC-accredited hospital at a cost of $1,423. For 
all 3,410 TJC-accredited hospitals to comply with these requirements 
would require an estimated 57,970 burden hours (17 burden hours for 
each TJC-accredited hospital x 3,410 TJC-accredited hospitals = 57,970 
burden hours) at a cost of $4,852,430 (1,423 estimated cost for each 
TJC-accredited hospital x 3,410 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.

[[Page 79136]]

    We estimate that complying with this requirement would require 33 
burden hours for each non TJC-accredited hospital at an estimated cost 
of $2,623. Based on this estimate, for all 1,518 non TJC-accredited 
hospitals to comply with these requirements would require 50,094 burden 
hours (33 burden hours for each non TJC-accredited hospital x 1,518 non 
TJC-accredited hospitals = 50,094 burden hours) at a cost of $3,981,714 
($2,623 estimated cost for each non TJC-accredited hospital x 1,518 non 
TJC-accredited hospitals = $3,981,714 estimated cost).
    In addition, we expect that there would be a burden as a result of 
proposed Sec.  482.15(b)(7). Proposed Sec.  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 x 4,928 hospitals = 39,512 burden hours) for all 
hospitals to comply with this requirement at a cost of $3,543,232 ($719 
estimated cost for each hospital x 4,928 hospitals = $3,543,232 
estimated cost).
    Based upon the previous estimates, for all hospitals to be in 
compliance with all of the requirements in Sec.  482.15(b) it would 
require 147,488 burden hours at a cost of $12,377,376.
    Proposed Sec.  482.15(b) would also require hospitals to review and 
update their emergency preparedness policies and procedures at least 
annually. We believe hospitals are already reviewing and updating their 
emergency preparedness policies and procedures periodically. Thus, 
compliance with this requirement would constitute a usual and customary 
business practice for both TJC-accredited and non TJC-accredited 
hospitals and would not be subject to the PRA in accordance with 5 CFR 
1320.3(b)(2).
    Proposed Sec.  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 Sec.  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 TJC-accredited hospitals would be in 
compliance with proposed Sec.  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 Sec.  
482.15(c)(5) through (c)(7). Therefore, we expect that TJC-accredited 
hospitals already have developed and are currently maintaining 
emergency communication plans that would satisfy the requirements 
contained in proposed Sec.  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 Sec.  482.15(c)(1) through 
(c)(4). Nevertheless, non TJC-accredited hospitals would need to 
review, update, and in some cases, develop new sections for their 
emergency communication plans to ensure they are in compliance with all 
of the proposed requirements in this subsection. We expect that this 
activity would require the involvement of the hospital's administrator, 
the risk management director, the facilities director, the health 
information services director, the security manager, and administrative 
support staff. We estimate that complying with this requirement would 
require 10 burden hours at a cost of $757 for each of the 1,518 non 
TJC-accredited hospitals. Therefore, based on this estimate, for non 
TJC-accredited hospitals to comply with this requirement would require 
15,180 burden hours (10 burden hours for each non TJC-accredited 
hospital x 1,518 non TJC-accredited hospitals =15,180 burden hours) at 
a cost of $1,149,126 ($757 estimated cost for each non TJC-accredited 
hospital x 1,518 non TJC-accredited hospitals = $1,149,126 estimated 
cost).
    Proposed Sec.  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

[[Page 79137]]

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 Sec.  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 Sec.  482.15(d)(1) and (2).
    Proposed Sec.  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 Sec.  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 Sec.  482.15(a)(1), (a), (b), 
and (c), respectively. Hospitals would need to revise and, if 
necessary, develop new sections or material to ensure that their 
training programs comply with our proposed requirements.
    The TJC-accredited hospitals are required to define staff roles and 
responsibilities in their EOP and train their staff for their assigned 
roles during emergencies (CAMH, EC.4.16, EPs 1-2, p. EC-13e). In 
addition, the TJC-accredited hospitals are required to provide an 
initial orientation, which includes information that the hospital has 
determined are key elements the staff need before they provide care, 
treatment, or services to patients (CAMH, Standard HR.2.10, EPs 1-2, 
CAMH Refreshed Core, January 2008, p. HR-10). We would expect that an 
orientation to the hospital's EOP would be part of this initial 
training. TJC-accredited hospitals also must provide on-going training 
to their staff, including training on specific job-related safety 
(CAMH, Standard HR-2.30, EP 4, CAMH Refreshed Core, January 2008, p. 
HR-11), and we expect that emergency preparedness is part of such on-
going training.
    Although TJC requirements do not specifically address training for 
individuals providing services under arrangement or training for 
volunteers consistent with their expected roles, it is 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 x 1,518 non TJC-
accredited hospitals = 60,720 burden hours) to comply with this 
requirement at a cost of $3,178,692 ($2,094 estimated cost for each 
hospital x 1,518 non TJC-accredited hospitals = $3,178,692 estimated 
cost).
    Proposed Sec.  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 Sec.  482.15(d)(2) would also require hospitals to 
participate in a community mock disaster drill and a paper-based, 
tabletop exercise at least annually. If a community mock disaster drill 
was not available, hospitals would have to conduct an individual, 
facility-based mock disaster drill. Hospitals also would be required to 
analyze their responses to, and maintain documentation of, all drills, 
exercises, and emergency events. If a hospital experienced an actual 
emergency which required activation of its emergency plan, it would be 
exempt from the requirement for a community or individual, facility-
based disaster drill for 1 year following the onset of the emergency 
(proposed Sec.  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

[[Page 79138]]

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 non-TJC accredited 
hospitals would be in compliance with our proposed requirements. Thus, 
we will analyze the burden for non TJC-accredited hospitals.
    The non TJC-accredited hospitals would be required to develop 
scenarios for a drill and an exercise and the documentation necessary 
to record and analyze their responses to drills, exercises, and 
emergency events. Based on our experience with hospitals, we expect 
that the same individuals who developed the emergency preparedness 
training program would develop the scenarios for the drills and 
exercises and the accompanying documentation. We expect that the health 
care trainer would spend more time developing the scenarios and 
documentation. Thus, for each of the 1,518 non TJC-accredited hospitals 
to comply with these requirements, we estimate that it would require 9 
burden hours at a cost of $523. Based on this estimate, for all 1,518 
non TJC-accredited hospitals to comply would require 13,662 burden 
hours (9 burden hours for each non TJC-accredited hospital x 1,518 non 
TJC-accredited hospitals =13,662 burden hours) at a cost of $793,914 
($523 estimated cost for each non TJC-accredited hospital x 1,518 non 
TJC-accredited hospital = $793,914 estimated cost).

  Table 7--Burden Hours and Cost Estimates for All 4,928 Hospitals To Comply With the ICRs Contained in Sec.   482.15 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                          Burden per     Total      labor cost  Total labor  Total capital/
         1800141075           OMB Control No.  Respondents   Responses     response      annual         of        cost of      maintenance    Total cost
                                                                           (hours)       burden     reporting    reporting      costs ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   482.15(a)(1).........  0938--New......        1,518        1,518           36       54,648           **    4,437,114               0    4,437,114
Sec.   482.15(a)(1)-(4).....  0938--New......        1,518        1,518           62       94,116           **    7,719,030               0    7,719,030
Sec.   482.15(b) (TJC-        0938--New......        3,410        3,410           17       57,970           **    4,852,430               0    4,852,430
 accredited).
Sec.   482.15(b) (Non TJC-    0938--New......        1,518        1,518           33       50,094           **    3,981,714               0    3,981,714
 accredited).
Sec.   482.15(b)(7).........  0938--New......        4,928        4,928            8       39,424           **    3,543,232               0    3,543,232
Sec.   482.15(c)............  0938--New......        1,518        1,518           10       15,180           **    1,449,126               0    1,449,126
Sec.   482.15(d)(1).........  0938--New......        1,518        1,518           40       60,720           **    3,178,692               0    3,178,692
Sec.   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 (Sec.  482.78)

    Proposed Sec.  482.78 would require transplant centers to have 
policies and procedures that address emergency preparedness. Proposed 
Sec.  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

[[Page 79139]]

770 transplant programs or transplant centers. CMS uses the terms 
transplant centers and transplant programs interchangeably (70 FR 6145 
and 72 FR 15210). Therefore, based on the previous estimate, for all 
770 transplant centers to comply with the requirement for an agreement, 
it would require 11,550 burden hours (15 burden hours for each 
transplant center x 770 transplant centers = 11,550 burden hours) at a 
cost of $1,068,760 ($1,388 estimated cost for each transplant center x 
770 transplant centers = $1,068,760 estimated cost).
    Proposed Sec.  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 Sec.  
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 x 238 hospitals= 3,570 burden hours) at 
a cost of $330,344 ($1,388 estimated cost for each hospital x 238 
hospitals = $330,344 estimated cost).

     Table 8--Burden Hours and Cost Estimates for All 770 Transplant Centers To Comply With the ICRs Contained in Sec.   482.78 Condition: Emergency
                                                           Preparedness for Transplant Centers
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                          Burden per     Total      labor cost  Total Labor  Total capital/
    Regulation section(s)     OMB Control No.  Respondents   Responses     response      annual         of        cost of      maintenance    Total cost
                                                                           (hours)       burden     reporting    reporting      costs ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   482.78(a)............  ...............          770          770           15       11,550           **    1,068,760               0    1,068,760
Sec.   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 (Sec.  483.73)

    Proposed Sec.  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 (Sec.  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 (Sec.  
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 (Sec.  
483.73(b)). Proposed Sec.  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 Sec.  483.73 are not subject 
to the PRA.

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

    Proposed Sec.  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 Sec.  483.475(a)(1) through (4). 
We will discuss the burden for these activities individually beginning 
with the risk assessment.
    Proposed Sec.  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 non-medical 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

[[Page 79140]]

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 Sec.  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 x 
6,442 ICFs/IID = 51,536 burden hours) for all ICFs/IID to comply with 
this requirement at a cost of $2,969,762 ($461 estimated cost for each 
ICF/IID x 6,442 ICFs/IID = $2,969,762 estimated cost).
    Under this proposed rule, ICFs/IID would be required to develop 
emergency preparedness plans that addressed the emergency events that 
could affect not only their facilities but also the communities in 
which they are located. An ICF/IID current disaster plan might not 
address all of the medical and non-medical emergency events identified 
by its risk assessment, include strategies for addressing those 
emergency events, or address its patient population. It may not specify 
the type of services the ICF/IID has the ability to provide in an 
emergency, or continuity of operations, including delegation of 
authority and succession plans. Thus, we expect that each ICFs/IID 
would have to review its current plans and compare them to its risk 
assessments. Each ICF/IID would then need to update, revise, and, in 
some cases, develop new sections to comply with our proposed 
requirements.
    The burden associated with this requirement would be the resources 
needed to review, revise, and develop new sections for an existing 
emergency plan. Based upon our experience with ICFs/IID, we expect that 
the same individuals who were involved in the risk assessment would be 
involved in developing the facility's new emergency preparedness plan. 
We also expect that developing the plan would require more time to 
complete than the risk assessment. We estimate that it would require 9 
burden hours at a cost of $525 for each ICF/IID to develop an emergency 
plan that complied with the requirements in this section. Based on this 
estimate, it would require 57,978 burden hours (9 burden hours for each 
ICF/IID x 6,442 ICFs/IID = 57,978 burden hours) to complete the plan at 
a cost of $3,382,050 ($525 estimated cost for each ICF/IID x 6,442 
ICFs/IID = $3,382,050 estimated cost).
    The ICF/IID also would be required to review and update its 
emergency preparedness plan at least annually. We believe that ICFs/IID 
already review their emergency preparedness plans periodically. Thus, 
compliance with this requirement would constitute a usual and customary 
business practice and would not be subject to the PRA in accordance 
with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  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'' (Sec.  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 (Sec.  
483.470(i)). We expect that all ICFs/IID have developed procedures for 
safe evacuation from and return to the ICF/IID (Sec.  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

[[Page 79141]]

would involve the ICF/IID administrator and a registered nurse. We 
estimate that for each ICF/IID to comply would require 9 burden hours 
at a cost of $525. Based on this estimate, for all 6,442 ICFs/IID to 
comply with this requirement would require 57,978 burden hours (9 
burden hours for each ICF/IID x 6,442 ICFs/IID = 57,978 burden hours) 
at a cost of $3,382,050 ($525 estimated cost for each ICF/IID x 6,442 
ICFs/IID = $3,382,050 estimated cost).
    We expect ICFs/IID to review and update their emergency 
preparedness policies and procedures at least annually. We believe that 
ICFs/IID already review their policies and procedures periodically. 
Thus, compliance with this requirement would constitute a usual and 
customary business practice and would not be subject to the PRA in 
accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  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 (Sec.  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 x 6,442 ICFs/IID = 38,652 burden 
hours) at a cost of $2,254,700 ($350 estimated cost for each ICF/IID x 
6,442 ICFs/IID = $2,254,700 estimated cost).
    ICFs/IID would also have to review and update their emergency 
preparedness communication plans at least annually. We believe that 
ICFs/IID already review their plans, policies, and procedures 
periodically. Thus, compliance with this requirement would constitute a 
usual and customary business practice and would not be subject to the 
PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  483.470(i).
    To comply with the requirements at Sec.  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 (Sec.  483.470(h)(2)). In addition, staff on 
all shifts must be trained to perform the tasks to which they are 
assigned for evacuations (Sec.  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 x 6,442 
ICFs/IID = 45,094 burden hours) to comply with this requirement at a 
cost of $2,338,446 ($363 estimated cost for each ICF/IID x 6,442 ICFs/
IID = $2,338,446 estimated cost).
    ICFs/IID would have to review and update their emergency 
preparedness training program at least annually. We believe that ICFs/
IID already review their emergency preparedness training programs 
periodically. Thus, compliance with this requirement would constitute a 
usual and customary business practice and would not be subject to the 
PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  483.475(d)(2) would require ICFs/IID to participate 
in a community mock disaster drill and a paper-based, tabletop exercise 
at least annually. The ICFs/IID would also be required to analyze their 
responses to and maintain documentation of all drills, tabletop 
exercises, and emergency events, and revise their emergency plans, as 
needed. If an ICF/IID experienced an actual natural or man-made 
emergency that required activation of its emergency plan, the ICF/IID 
would be exempt from engaging in a community or individual, facility-
based mock disaster drill for 1 year

[[Page 79142]]

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'' (Sec.  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 x 6,442 ICFs/IID = 25,768 burden hours) at a cost of 
$1,211,096 ($188 estimated cost for each ICF/IID x 6,442 ICFs/IID = 
$1,211,096 estimated cost).

  Table 9--Burden Hours and Cost Estimates for All 6,442 ICFs/IID To Comply With the ICRs Contained in Sec.   485.475 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                          Burden per     Total      labor cost  Total labor  Total capital/
    Regulation section(s)     OMB control No.  Respondents   Responses     response      annual         of        cost of      maintenance    Total cost
                                                                           (hours)       burden     reporting    reporting      costs ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   483.475(a)(1)........  ...............        6,442        6,442            8       51,536           **    2,969,762               0    2,969,762
Sec.   483.475(a)(1)-(4)....  ...............        6,442        6,442            9       57,978           **    3,382,050               0    3,382,050
Sec.   483.475(b)...........  ...............        6,442        6,442            9       57,978           **    3,382,050               0    3,382,050
Sec.   483.475(c)...........  ...............        6,442        6,442            6       38,652           **    2,254,700               0    2,254,700
Sec.   483.475(d)(1)........  ...............        6,442        6,442            7       45,094           **    2,338,446               0    2,338,446
Sec.   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 
(Sec.  484.22)

    Proposed Sec.  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 
Sec.  484.22(a)(1) through (4). We will discuss the burden for these 
activities individually, beginning with the risk assessment.
    Accreditation may substantially affect the burden a HHA would 
experience under this proposed rule. HHAs are accredited by three 
different accrediting organizations (AOs): The Joint Commission (TJC), 
The Community Health Accreditation Program (CHAP), and the 
Accreditation Commission for Health Care, Inc. (ACHC). After reviewing 
the accreditation standards for all three AOs, neither the standards 
for CHAP nor the ones for ACHC appeared to ensure substantial 
compliance with our proposed requirements in this rule. Therefore, the 
HHAs accredited by CHAP and ACHC will be included with the non-
accredited HHAs for the purposed of determining the burden for this 
proposed rule.
    There are currently 12,349 HHAs. There are 1,734 TJC-accredited 
HHAs. A review of TJC deeming standards indicates that the 1,734 TJC-
accredited HHAs already perform certain tasks or activities that would 
partially or completely satisfy our proposed requirements. Therefore, 
since TJC accreditation is a significant factor in determining the 
burden, we will analyze the burden for the 1,734 TJC-accredited HHAs 
separately from the 10,615 non 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

[[Page 79143]]

(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 TJC-accredited HHAs have conducted some type of 
risk assessment. However, those risk assessments are unlikely to 
satisfy all of our proposed requirements. Therefore, we will analyze 
the burden for the 10,615 non 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 TJC-accredited HHA x 10,615 non TJC-accredited HHAs = 
116,765 burden hours) at a cost of $6,422,075 ($605 estimated cost for 
each non TJC-accredited HHA x 10,615 non TJC-accredited HHAs = 
$6,422,075 estimated cost).
    After conducting a risk assessment, HHAs would have to develop an 
emergency preparedness plan that complied with Sec.  484.22(a)(1) 
through (4). As discussed earlier, TJC already has accreditation 
standards similar to the requirements we propose at Sec.  484.22(a). 
Thus, we expect that TJC-accredited HHAs have an emergency preparedness 
plan that would satisfy most of our proposed requirements. Although the 
current HHA CoPs require that there be a qualified person who ``is 
authorized in writing to act in the absence of the administrator'' 
(Sec.  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 TJC-accredited HHAs already have some 
type of emergency preparedness plan, as well as delegations of 
authority and succession plans. However, we also expect that their 
plans do not comply with all of our proposed requirements. Thus, all 
non TJC-accredited HHAs would need to review their current plans and 
compare them to their risk assessments. They also would need to update, 
revise, and, in some cases, develop new sections for their emergency 
plans.
    Based on our experience with HHAs, we expect that the same 
individuals who were involved in the risk assessment would be involved 
in developing the emergency preparedness plan. We estimate that 
complying with this requirement would require 10 burden hours for each 
TJC-accredited HHA at a cost of $546. Therefore, for all 1,734 TJC-
accredited HHAs to comply would require an estimated 17,340 burden 
hours (10 burden hours for each TJC-accredited HHA x 1,734 TJC-
accredited HHAs = 17,340 burden hours) at a cost of $946,764 ($546 
estimated cost for each HHA x 1,734 TJC-accredited HHAs = $946,764 
estimated cost).
    We estimate that complying with this requirement would require 15 
burden hours for each of the 10,615 non TJC-accredited HHAs at a cost 
of $819. Therefore, for all 10,615 non TJC-accredited HHAs to comply 
would require an estimated 159,225 burden hours (15 burden hours for 
each non TJC-accredited HHA x 10,615 non TJC-accredited HHAs = 159,225 
burden hours) at a cost of $8,693,685 ($819 estimated cost for each non 
TJC-accredited HHA x 10,615 non TJC-accredited HHAs = $8,693,685 
estimated cost).
    Based on these estimates, for all 12,349 HHAs to develop an 
emergency preparedness plan that complies with our proposed 
requirements would require 176,565 burden hours at a cost of 
$9,640,449.
    We would also require HHAs to review and update their emergency 
preparedness plans at least annually. We believe that HHAs are already 
reviewing and updating their emergency preparedness plans periodically. 
Hence, compliance with this requirement would constitute a usual and 
customary business practice for HHAs and would not be subject to the 
PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 
Sec.  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 Sec.  484.22(b)(1) through (6).
    We expect that HHAs would review their emergency preparedness 
policies

[[Page 79144]]

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 TJC-accredited HHAs already have emergency 
preparedness policies and procedures that address some of the proposed 
requirements at Sec.  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 Sec.  484.22(b).
    Under proposed Sec.  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 Sec.  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 Sec.  
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 
Sec.  484.22(b)(1) and (b)(2). For example, regulations at Sec.  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 Sec.  484.18(a). 
Thus, the activities necessary to be in compliance with Sec.  
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 Sec.  484.22(3) through (6). We expect 
that a professional staff person, most likely the director of nursing, 
would review the HHA's policies and procedures and make recommendations 
for changes or development of additional policies and procedures. The 
administrator or director of nursing would brief representatives of 
most of the HHA's major departments and assign staff to make necessary 
revisions and draft any new policies and procedures. We estimate that 
complying with this requirement would require 18 burden hours for each 
HHA at a cost of $996. Thus, for all 12,349 HHAs to comply with all of 
our proposed requirements would require an estimated 222,282 burden 
hours (18 burden hours for each HHA x 12,349 HHAs = 222,282 burden 
hours) at a cost of $12,299,604 ($996 estimated cost for each HHA x 
12,349 HHAs = $12,299,604 estimated cost).
    We are also proposing that HHAs review and update their emergency 
preparedness policies and procedures at least annually. The current HHA 
CoPs already require that ``a group of professional personnel . . . 
reviews the agency's policies governing scope of services offered'' (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 Sec.  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 
Sec.  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

[[Page 79145]]

manager. We estimate that complying with this requirement would require 
10 burden hours for each HHA at a cost of $520. Thus, for all 12,349 
HHAs to comply with these requirements would require an estimated 
123,490 burden hours (10 burden hours for each HHA x 12,349 HHAs = 
123,490 burden hours) at a cost of $6,421,480 ($520 estimated cost for 
each HHA x 12,349 HHAs = $6,421,480 estimated cost).
    We propose requiring HHAs to review and update their emergency 
preparedness communication plans at least annually. We believe that 
HHAs already review their emergency preparedness plans periodically. 
Thus, compliance with this requirement would constitute a usual and 
customary business practice for HHAs and would not be subject to the 
PRA in accordance with 5 CFR 1320.3(b)(2).
    Section 484.22(d) would require each HHA to develop and maintain an 
emergency preparedness training and testing program. Each HHA would 
also have to review and update its training and testing program at 
least annually. We propose requiring that each HHA meet the 
requirements listed at Sec.  484.22(d)(1) and (2).
    Proposed Sec.  484.22(d)(1) states that each HHA would have to 
provide initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing 
services under arrangement, and volunteers, consistent with their 
expected roles, and maintain documentation of the training. Thereafter, 
the HHA would have to provide emergency preparedness training at least 
annually. Each HHA would also have to ensure that their staff could 
demonstrate knowledge of their emergency procedures.
    Based on our experience with HHAs, we expect that all 12,349 HHAs 
have some type of emergency preparedness training program. The 1,734 
TJC-accredited HHAs are already required to provide both an initial 
orientation to their staff before they can provide care, treatment, or 
services (CAMHC, Standard HR.2.10, EP 2, p. HR-6) and ``ongoing in-
services, training or other staff activities [that] emphasize job-
related aspects of safety . . .'' (CAMHC, Standard HR.2.30, EP 4, p. 
HR-8). Since emergency preparedness is a critical aspect of 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 Sec.  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 x 12,349 HHAs = 197,584 burden 
hours) at a cost of $9,335,844 ($756 estimated cost for each HHA x 
12,349 HHAs = $9,335,844 estimated cost).
    We also propose requiring HHAs to review and update their emergency 
preparedness training programs at least annually. We believe that HHAs 
already review their training and testing programs periodically. Thus, 
compliance with this requirement would constitute a usual and customary 
business practice for HHAs and would not be subject to the PRA in 
accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  484.22(d)(2) would require each HHA to conduct 
drills and exercises to test its emergency plan. Each HHA would have to 
participate in a community mock disaster drill and conduct a paper-
based, tabletop exercise at least annually. If a community mock 
disaster drill was not available, each HHA would have to conduct an 
individual, facility-based mock disaster drill at least annually. If an 
HHA experienced an actual natural or man-made emergency that required 
activation of the emergency plan, it would be exempt from engaging in a 
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 TJC-accredited HHAs in our analysis 
of the burden for these requirements.
    Based on our experience with HHAs, we expect that the same 
individuals who are responsible for developing the HHA's training and 
testing program would develop the scenarios for the drills and 
exercises and the accompanying documentation. We expect that the 
director of nursing would spend more time on these activities than 
would the other individuals. We estimate that it would require 8 burden 
hours for each HHA to comply with the proposed requirements at 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.

[[Page 79146]]



   Table 10--Burden Hours and Cost Estimates for All 12,349 HHAS To Comply With the ICRs Contained in Sec.   484.22 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly       Total
                                                                         Burden  per     Total     labor  cost  labor  cost  Total  capital/
    Regulation section(s)       OMB  Control    Number  of   Number  of    response      annual         of           of         maintenance   Total cost
                                    No.        respondents   responses     (hours)       burden     reporting    reporting     costs  ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   484.22(a)(1).........  0938--New......       10,615       10,615           11      116,765           **    6,422,075               0    6,422,075
Sec.   484.22(a)(1)-(4) (TJC- 0938--New......        1,734        1,734           10       17,340           **      946,764               0      946,764
 accredited).
Sec.   484.22(a)(1)-(4) (Non  0938--New......       10,615       10,615           18      159,225           **    8,693,685               0    8,693,685
 TJC-accredited).
Sec.   484.22(b)............  0938--New......       12,349       12,349           18      222,282           **   12,299,604               0   12,299,604
Sec.   484.22(c)............  0938--New......       12,349       12,349           10      123,490           **    6,421,480               0    6,421,480
Sec.   484.22(d)(1).........  0938--New......       12,349       12,349           16      197,584           **    9,335,844               0    9,335,844
Sec.   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 
(Sec.  485.68)

    Proposed Sec.  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 Sec.  
485.68(a)(1) through (5).
    Proposed Sec.  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'' (Sec.  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 x 272 CORFs = 2,176 burden hours) for all CORFs to 
comply at a cost of $131,920 ($485 estimated cost for each CORF x 272 
CORFs = $131,920 estimated cost).
    After conducting the risk assessment, each CORF would need to 
review, revise, and, if necessary, develop new sections for its 
emergency plan so that it complied with our proposed requirements. The 
current CoPs for CORFs require them to have a written disaster plan 
(Sec.  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 
(Sec.  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 x 272 CORFs 
= 2,992 burden hours) for all CORFs to complete an emergency 
preparedness plan at a cost of $184,144 ($677 estimated cost for each 
CORF x 272 CORFs = $184,144 estimated cost).
    The CORF also would be required to review and update its emergency 
preparedness plan at least annually. We believe that CORFs already 
review their plans periodically. Therefore, compliance with the 
requirement for an annual review of the emergency preparedness plan 
would constitute a usual and customary business practice for CORFs and 
would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  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 Sec.  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

[[Page 79147]]

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 x 272 
CORFs = 2,448 burden hours) to comply with this requirement at a cost 
of $149,328 ($549 estimated cost for each CORF x 272 CORFs = $149,328 
estimated cost).
    Proposed Sec.  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 Sec.  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 Sec.  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'' (Sec.  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 x 272 CORFs = 2,176 burden 
hours) for all CORFs to comply at a cost of $131,920 ($485 estimated 
cost for each CORF x 272 CORFs = $131,920 estimated cost).
    We propose that each CORF would also have to review and update its 
emergency preparedness communication plan at least annually. We believe 
that compliance with this requirement would constitute a usual and 
customary business practice for CORFs and would not be subject to the 
PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  
485.68(d)(1) and (2).
    Proposed Sec.  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 Sec.  485.64 require CORFs to ensure that 
all personnel are knowledgeable, trained, and assigned specific 
responsibilities regarding the facility's disaster procedures. Section 
Sec.  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, Sec.  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 Sec.  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 x 272 CORFs 
= 2,176 burden hours) at a cost of $131,920 ($485 estimated cost for 
each CORF x 272 CORFs = $131,920 estimated cost).
    We also propose that each CORF review and update its emergency 
preparedness training program at least annually. We believe that CORFs 
already review their training programs periodically. Thus, complying 
with the requirement for an annual review of the emergency preparedness 
training program would constitute a usual and customary business 
practice for CORFs and would not be subject to the PRA in accordance 
with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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

[[Page 79148]]

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 Sec.  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 x 272 CORFs = 1,632 burden hours) at a cost of $99,552 
($366 estimated cost for each CORF x 272 CORFs = $99,552 estimated 
cost).
    Based on the previous analysis, for all 272 CORFs to comply with 
the ICRs contained in this proposed rule would require 13,600 total 
burden hours at a total cost of $828,784.

    Table 11--Burden Hours and Cost Estimates for All 272 CORFS To Comply With the ICRs Contained in Sec.   485.68 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                          Burden per     Total      labor cost  Total labor  Total capital/
    Regulation section(s)     OMB Control No.  Respondents   Responses     response      annual         of        cost of      maintenance    Total cost
                                                                           (hours)       burden     reporting    reporting      costs ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   485.68(a)(1).........  0938--New......          272          272            8        2,176           **      131,920               0      131,920
Sec.   485.68(a)(2-(4)......  0938--New......          272          272           11        2,992           **      184,144               0      184,144
Sec.   485.68(b)............  0938--New......          272          272            9        2,448           **      149,328               0      149,328
Sec.   485.68(c)............  0938--New......          272          272            8        2,176           **      131,920               0      131,920
Sec.   485.68(d)(1).........  0938--New......          272          272            8        2,176           **      131,920               0      131,920
Sec.   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 
(Sec.  485.625)

    Proposed Sec.  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 Sec.  485.625(a)(1) through (4).
    Proposed Sec.  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 non-accredited 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 TJC-accredited and 32 AOA-accredited CAHs separately 
from the non-accredited CAHs. Note that we obtain data on the number of 
CAHs, both accredited and non-accredited, from the CMS CASPER database, 
which is updated periodically by the individual states. Due to 
variations in the timeliness of the data submissions, all numbers are 
approximate, and the number of accredited and non-accredited CAHs may 
not equal the total number of CAHs.
    For purposes of determining the burden for TJC-accredited CAHs, we 
used TJC's Comprehensive Accreditation Manual for Critical Access 
Hospitals: The Official Handbook 2008 (CAMCAH). In the chapter 
entitled, ``Management of the Environment of Care'' (EC), Standard 
EC.4.11 requires CAHs to plan for managing the consequences of 
emergency events (CAMCAH, Standard EC.4.11, CAMCAH Refreshed Care, 
January 2008, pp. EC-10--EC-11). CAHs are required to perform a hazard 
vulnerability analysis (HVA), which requires each CAH to, among other 
things, ``identify events that could affect demand for its services or 
its ability to provide those services, the likelihood of those events 
occurring, and the consequences of those events'' (Standard EC.4.11, EP 
2, p. EC-10a). The HVA ``should identify potential hazards, threats, 
and adverse events, and assess their impact on the care, treatment, and 
services [the CAH] must sustain during an emergency,'' and the HVA ``is 
designed to assist [CAHs] in gaining a realistic understanding of their 
vulnerabilities, and to help focus their resources and planning 
efforts'' (CAMCAH, Emergency Management, Introduction, p. EC-10). Thus, 
we expect that TJC-accredited CAHs already conduct a risk assessment 
that would comply with the requirements we propose. Thus, for the 370 
TJC-accredited CAHs, the risk assessment requirement would constitute a 
usual and customary business practice and would not be subject to the 
PRA in accordance with 5 CFR 1320.3(b)(2).
    For purposes of determining the burden for AOA-accredited CAHs, we 
used the AOA's Healthcare Facilities Accreditation Program: 
Accreditation Requirements for Critical Access CAHs 2007 (ARCAH). In 
Chapter 11 entitled, ``Physical Environment,'' CAHs are required to 
have disaster plans, external disaster plans that include triaging 
victims, and weapons of mass destruction response plans (ARCAH, 
Standards 11.07.01, 11.07.02, and 11.07.05-6, pp. 11-38 through 11-41, 
respectively). In addition, AOA-accredited CAHs must ``coordinate with 
federal, state, and local emergency preparedness and health authorities 
to identify likely risks for their area . . . and to develop 
appropriate responses'' (ARCAH, Standard 11.02.02, p. 11-5). Thus, we 
believe that to develop their plans, AOA-accredited CAHs already 
perform some type of risk assessment. However, the AOA standards do not 
require a documented facility-based and community-based risk 
assessment, as we propose. Therefore, we will include the 32 AOA-
accredited CAHs with non-

[[Page 79149]]

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 (Sec.  485.623) and to take 
appropriate measures that are consistent with the particular conditions 
in the area in which the CAH is located (42 CFR 485.623(c)(4)). To 
satisfy this requirement in the CoPs, we expect that CAHs have already 
conducted some type of risk assessment. However, that requirement does 
not ensure that CAHs have conducted a documented, facility-based, and 
community-based risk assessment that would satisfy our proposed 
requirements.
    We believe that under this proposed rule, the 952 non TJC-
accredited CAHs (1,322 CAHs - 370 TJC-accredited CAHs = 952 non TJC-
accredited CAHs) would need to review, revise, and, in some cases, 
develop new sections for their current risk assessments to ensure 
compliance with all of our requirements.
    We have not designated any specific process or format for CAHs to 
use in conducting their risk assessments because we believe that CAHs 
need the flexibility to determine the best way to accomplish this task. 
However, we expect that CAHs would include representatives from or 
obtain input from all of their major departments in the process of 
developing their risk assessments.
    Based on our experience with CAHs, we expect that these activities 
would require the involvement of a CAH's administrator, medical 
director, director of nursing, facilities director, and food services 
director. We expect that these individuals would attend an initial 
meeting, review relevant sections of the current risk assessment, 
provide comments, attend a follow-up meeting, perform a final review, 
and approve the new or updated risk assessment. We expect the 
administrator would coordinate the meetings, perform an initial review 
of the current risk assessment, coordinate comments, develop the new 
risk assessment, and ensure that the necessary parties approved it.
    We estimate that the risk assessment requirement would require 15 
burden hours to complete at a cost of $949. We estimate that for the 
952 non TJC-accredited CAHs to comply with the proposed risk assessment 
requirement would require 14,280 burden hours (15 burden hours for each 
CAH x 952 non TJC-accredited CAHs = 14,280 burden hours) at a cost of 
$903,448 ($949 estimated cost for each non TJC-accredited CAH x 952 non 
TJC-accredited CAHs = $903,448 estimated cost).
    After conducting the risk assessment, CAHs would have to develop 
and maintain emergency preparedness plans that complied with proposed 
Sec.  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 Sec.  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 (Sec.  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 (Sec.  
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 AOA-accredited CAHs = 952 non TJC-accredited 
CAHs) to comply with this requirement would require 24,752 burden hours 
(26 burden hours for each

[[Page 79150]]

non TJC-accredited CAH x 952 non TJC-accredited CAHs = 24,752 burden 
hours) at a cost of $1,542,240 ($1,620 estimated cost for each non TJC-
accredited CAH x 952 non TJC-accredited CAHs = $1,542,240 estimated 
cost).
    Under this proposed rule, CAHs also would be required to review and 
update their emergency preparedness plans at least annually. The CAH 
CoPs already require CAHs to perform a periodic evaluation of their 
total program at least once a year (Sec.  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 Sec.  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 Sec.  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 Sec.  485.625(b)(1) through (8).
    We expect that all CAHs would review their policies and procedures 
and compare them to their risk assessments, emergency preparedness 
plans, and emergency communication plans. The CAHs would need to 
revise, and, in some cases, develop new policies and procedures to 
incorporate all of the provisions previously noted and address all of 
our proposed requirements.
    The CAMCAH chapter entitled, ``Leadership'' (LD), requires TJC-
accredited CAH leaders to ``develop policies and procedures that guide 
and support patient care, treatment, and services'' (CAMCAH, Standard 
LC.3.90, EP 1, CAMCAH Refreshed Core, January 2008, p. LD-11). Thus, we 
expect that TJC-accredited CAHs already have some policies and 
procedures for the activities and processes required for accreditation, 
including their EOP. As discussed later, many of the required elements 
we propose have a corresponding requirement in the CAH TJC 
accreditation standards.
    We propose at Sec.  485.625(b)(1) that CAHs have policies and 
procedures that address the provision of subsistence needs for staff 
and patients, whether they evacuate or shelter in place. TJC-accredited 
CAHs must make plans for obtaining and replenishing medical and non-
medical supplies, including food, water, and fuel for generators and 
transportation vehicles (CAMCAH, Standard EC.4.14, EPs 1-4, p. EC-10d). 
In addition, they must identify alternative means of providing 
electricity, water, fuel, and other essential utility needs in cases 
where their usual supply is disrupted or compromised (CAMCAH, Standard 
EC.4.17, EPs 1-5, p. EC-10f). We expect that TJC-accredited CAHs that 
comply with these requirements would be in compliance with our proposed 
requirement concerning subsistence needs at Sec.  485.625(b)(1).
    We are proposing at Sec.  485.625(b)(2) that CAHs have policies and 
procedures for a system to track the location of staff and patients in 
the CAH's care both during and after an emergency. TJC-accredited CAHs 
must plan for communicating with their staff, as well as patients and 
their families, at the beginning of and during an emergency (CAMCAH, 
Standard EC.4.13, EPs 1, 2, and 5, p. EC-10c). We expect that TJC-
accredited CAHs that comply with these requirements would be in 
compliance with our proposed requirement.
    Proposed Sec.  485.625(b)(3) would require CAHs to have a plan for 
the safe evacuation from the CAH. TJC-accredited CAHs are required to 
make plans to evacuate patients as part of managing their clinical 
activities (CAMCAH, Standard EC.4.18, EP 1, p. EC-10g). They also must 
plan for the evacuation and transport of patients, their information, 
medications, supplies, and equipment to alternative care sites (ACSs) 
when the CAH cannot provide care, treatment, and services in its 
facility (CAMCAH, Standard EC.4.14, EPs 9-11, p. EC-10d). We expect 
that TJC-accredited CAHs that comply with these requirements would be 
in compliance with our proposed requirement.
    We are proposing at Sec.  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 TJC-accredited CAHs would be substantially in compliance with our 
proposed requirement.
    Proposed Sec.  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 
Sec.  485.625(b)(5).
    Proposed Sec.  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. TJC-accredited 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 TJC-accredited CAHs would be 
in compliance with all requirements in proposed Sec.  485.625(b)(6).
    Based upon the previous discussion, we expect that the activities 
required for compliance by TJC-accredited CAHs

[[Page 79151]]

with Sec.  485.625(b)(1) through (b)(5) constitutes usual and customary 
business practices for PRAs and would not be subject to the PRA in 
accordance with 5 CFR 1320.3(b)(2).
    However, we do not believe TJC-accredited CAHs would be 
substantially in compliance with proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  485.625(b)(4), AOA-accredited CAHs are 
required to consider the special needs of their patient population and 
the security of those patients and others that come to them for care 
when they develop their emergency plans (ARCAH, Standard 11.02.02 
Building Safety, Elements 2 and 3, p. 11-5). In addition, as described 
earlier, they also must consider the food, pharmaceuticals, and other 
supplies and equipment they may need during an emergency in developing 
their emergency plan (ARCAH, Standard 11.02.02, Element 5, p. 11-5). 
However, these requirements do not specifically mention volunteers and 
CAHs are required only to consider these elements in developing their 
plans.
    Therefore, we believe that AOA-accredited CAHs have likely already 
incorporated many of the elements necessary to satisfy the requirements 
in proposed Sec.  485.625(b); however, they would need to thoroughly 
review their current policies and procedures and perform whatever tasks 
are necessary to ensure that they complied with all of our proposed 
requirements for emergency policies and procedures. Because we expect 
that AOA-accredited CAHs already comply with many of our proposed 
requirements, we will include the AOA-accredited CAHs with the TJC-
accredited CAHs in determining the burden.
    The burden for the 32 AOA-accredited CAHs and the 370 TJC-
accredited CAHs to comply with all of the requirements in proposed 
Sec.  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 AOA-accredited CAHs to comply with these 
requirements would require an estimated 4,020 burden hours (10 burden 
hours for each TJC or AOA-accredited CAH x 402 TJC and AOA-accredited 
CAHs = 4,020 burden hours) at a cost of $327,228 ($814 estimated cost 
for each TJC or AOA-accredited CAH x 402 TJC and AOA-accredited CAHs = 
$327,228 estimated cost).
    We expect that the 920 non-accredited CAHs already have developed 
some emergency preparedness policies and procedures. The current CAH 
CoPs require CAHs to develop, maintain, and review policies to ensure 
quality care and a safe environment for their patients (Sec.  
485.627(a), Sec.  485.635(a), and Sec.  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 
(Sec.  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

[[Page 79152]]

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 
non-accredited CAH's compliance would require 14 burden hours at a cost 
of $860. For all 920 unaccredited CAHs to comply with this requirement 
would require an estimated 12,880 burden hours (14 burden hours for 
each non-accredited CAHs x 920 non-accredited CAHs = 12,880 burden 
hours) at a cost of $791,200 ($860 estimated cost for each non-
accredited CAH x 920 non-accredited CAHs = $791,200 estimated cost).
    Thus, for all 1,322 CAH to comply with the requirements in proposed 
Sec.  485.625(b) would require 16,900 burden hours at a cost of 
$1,118,428.
    Proposed Sec.  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 AOA-accredited CAHs already 
periodically review their policies and procedures. In addition, the 
existing CAH CoPs require periodic reviews of the CAH's health care 
policies (Sec.  485.627(a), Sec.  485.635(a), and Sec.  
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 Sec.  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 Sec.  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 Sec.  
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 Sec.  
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 Sec.  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 Sec.  485.625(c)(4) through (7). Thus, we will include 
these 32 AOA-accredited CAHs in the burden below.
    The burden associated with complying with this requirement would be 
the resources required to develop a communication plan that complied 
with the requirements of this section. Based on our experience with 
CAHs, we expect that accomplishing these activities would require the 
involvement of an administrator, director of nursing, and the 
facilities director. We expect that the administrator would review the 
communication plan and make recommendations for necessary changes or 
additions. The director of nursing and the facilities director would 
meet with the administrator to discuss and revise or draft new sections 
for the CAH's existing emergency communication plan. We estimate that 
complying with this requirement would require 9 burden hours for each 
CAH at a cost of $519. We estimate that for all 1,322 CAHs to comply 
with the requirements for an emergency preparedness communication plan 
would require 11,898 burden hours (9 burden hours for each CAH x 1,322 
CAHs = 11,898 burden hours) at a cost of $686,118 ($519 estimated cost 
for each CAH x 1,322 CAHs = $686,118 estimated cost).
    Proposed Sec.  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 (Sec.  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 Sec.  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 Sec.  485.625(d)(1) and (2).
    Regarding Sec.  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 (Sec.  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

[[Page 79153]]

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 x 1,322 CAHs = 18,508 burden hours) 
at a cost of $1,102,548 ($834 estimated cost for each CAH x 1,322 CAHs 
= $1,102,548 estimated cost).
    Proposed Sec.  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 (Sec.  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 Sec.  485.625(d)(2) would require CAHs to participate in a 
community mock disaster drill and a paper-based, tabletop exercise at 
least annually. If a community mock disaster drill was not available, 
the CAH would have to conduct an individual, facility-based mock 
disaster drill at least annually. CAHs also would be required to 
analyze the CAH's response to and maintain documentation of all drills, 
tabletop exercises, and emergency events, and revise the CAH's 
emergency plan, as needed. If a CAH experienced an actual natural or 
man-made emergency that required activation of the emergency plan, it 
would be exempt from the proposed requirement for an annual community 
or individual, facility-based mock disaster drill for 1 year following 
the onset of the emergency (proposed Sec.  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 non-accredited CAHs to comply with 
these requirements would require an estimated 7,360 burden hours (8 
burden hours for each non-accredited CAH x 920 non-accredited CAHs = 
7,360 burden hours) at a cost of $448,960 ($488 estimated cost for each 
non-accredited CAH x 920 non-accredited CAHs = $448,960 estimated 
cost).

[[Page 79154]]



   Table 12--Burden Hours and Cost Estimates for ALL 1,322 CAHS to Comply With the ICRs Contained in Sec.   485.625 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                          Burden per     Total      labor cost  Total labor  Total capital/
    Regulation section(s)     OMB Control No.  Respondents   Responses     response      annual         of        cost of      maintenance    Total cost
                                                                           (hours)       burden     reporting    reporting      costs ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   485.625(a)(1)........  0938--New......          952          952           15       14,280           **      903,448               0      903,448
Sec.   485.625(a)(2)-(4)....  0938--New......          952          952           26       24,752           **    1,542,240               0    1,542,240
Sec.   485.625(b) (TJC and    0938--New......          402          402           10        4,020           **      327,228               0      327,228
 AOA-Accredited).
Sec.   485.625(b) (Non-       0938--New......          920          920           14       12,880           **      791,200               0      791,200
 accredited).
Sec.   485.625(c)...........  0938--New......         1322         1322            9       11,898           **      686,118               0      686,118
Sec.   485.625(d)(1)........  0938--New......         1322         1322           14       18,508           **    1,102,548               0    1,102,548
Sec.   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 
(Sec.  485.727)

    Proposed Sec.  485.727(a) would require clinics, rehabilitation 
agencies, and public health agencies as providers of outpatient 
physical therapy and speech-language pathology services (organizations) 
to develop and maintain emergency preparedness plans and review and 
update the plan at least annually. We are proposing that the plan 
comply with the requirements listed at Sec.  485.727(a)(1) through (6).
    Proposed Sec.  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'' (Sec.  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 x 2,256 organizations = 20,304 burden hours) for all 
organizations to comply with this requirement at a cost of $1,238,544 
($549 estimated cost for each organization x 2,256 organizations = 
$1,238,544 estimated cost).
    After conducting the risk assessment, each organization would need 
to develop and maintain an emergency preparedness plan and review and 
update it at least annually. Current CoPs require these providers to 
have a written disaster plan with accompanying procedures for fires, 
explosions, and other disasters (Sec.  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 (Sec.  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 x 2,256 organizations = 27,072 burden hours) to complete 
the plan at a cost of $1,671,696 ($741 estimated cost for each 
organization x 2,256 organizations = $1,671,696 estimated cost).
    Each organization would also be required to review and update its 
emergency preparedness plan at least annually. We believe that these 
organizations already review their plans periodically. Thus, complying 
with this requirement would constitute a usual and customary business 
practice for organizations and would not be subject to the PRA in 
accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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

[[Page 79155]]

Sec.  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 Sec.  
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 (Sec.  
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 Sec.  485.727(a)(1) through (4) 
are similar to our proposed requirements at Sec.  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 x 2,256 organizations = 23,550 burden hours) at a cost of 
$1,382,928 ($622 estimated cost for each organization x 2,256 
organizations = $1,382,928 estimated cost).
    We would require organizations to review and update their emergency 
preparedness policies and procedures at least annually. We believe that 
these providers already review their emergency preparedness policies 
and procedures periodically. Therefore, compliance with this 
requirement would constitute a usual and customary business practice 
and would not be subject to the PRA in accordance with 5 CFR 
1320.3(b)(2).
    Proposed Sec.  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 Sec.  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'' (Sec.  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 x 2,256 
organizations = 18,048 burden hours) at a cost of $1,114,464 ($494 
estimated cost for each organization x 2,256 organizations = $1,114,464 
estimated cost).
    We are proposing that organizations must review and update their 
emergency preparedness communication plans at least annually. We 
believe that these organizations already review their emergency 
communication plans periodically. Thus, compliance with this 
requirement would constitute a usual and customary business practice 
and would not be subject to the PRA in accordance with 5 CFR 
1320.3(b)(2).
    Proposed Sec.  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 
Sec.  485.727(d)(1) and (2).
    With respect to Sec.  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 x 2,256 organizations = 18,048 burden 
hours) to comply with this requirement at a cost of $1,114,464 ($494 
estimated cost for each organization x 2,256 organizations = $1,114,464 
estimated cost).
    In Sec.  485.727(d)(1), we also propose requiring that an 
organization must review and update its emergency

[[Page 79156]]

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 Sec.  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'' (Sec.  485.727(a) and (b)). Thus, we expect that all 2,256 
organizations currently conduct some type of drill or exercise of their 
disaster plan. However, the current organizations CoPs do not specify 
the type of drill, how they are to conduct the drills, or whether the 
drills should be community-based. In addition, there is no requirement 
for a paper-based, tabletop exercise. Thus, these requirements do not 
ensure that organizations would be in compliance with our proposed 
requirements. Therefore, we will analyze the burden from these 
requirements for all organizations.
    The 2,256 organizations would be required to develop scenarios for 
a mock disaster drill and a paper-based, tabletop exercise and the 
necessary documentation. Based on our experience with organizations, we 
expect that the same individuals who develop the emergency preparedness 
training program would develop the scenarios for the drills and 
exercises and the accompanying documentation. We expect that the 
administrator would spend more time than the physical therapist 
developing the scenarios and the documentation. We estimate that for 
each organization to comply would require 3 burden hours at a cost of 
$183. Based on that estimate, it would require 6,768 burden hours (3 
burden hours for each organization x 2,256 organizations = 6,768 burden 
hours) at a cost of $417,360 ($183 estimated cost for each organization 
x 2,256 organizations = $417,360 estimate cost).

     Table 13--Burden Hours and Cost Estimates for All 2,256 Organizations To Comply With the ICRs Contained in Sec.   485.727 Condition: Emergency
                                                                      Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                         Burden  per     Total      labor cost  Total labor  Total capital/
   Regulation  section(s)     OMB Control No.  Respondents   Responses     response      annual         of        cost of      maintenance    Total cost
                                                                           (hours)       burden     reporting    reporting     costs  ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   485.727(a)(1)........  0938--New......        2,256        2,256            9       20,304           **    1,238,544               0    1,238,544
Sec.   485.727(a)(2)-(4)....  0938--New......        2,256        2,256           12       27,072           **    1,671,696               0    1,671,696
Sec.   485.727(b)...........  0938--New......        2,256        2,256           10       22,560           **    1,382,928               0    1,382,928
Sec.   485.727(c)...........  0938--New......        2,256        2,256            8       18,048           **    1,114,464               0    1,114,464
Sec.   485.727(d)(1)........  0938--New......        2,256        2,256            8       18,048           **    1,114,464               0    1,114,464
Sec.   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 
(Sec.  485.920)

    Proposed Sec.  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 Sec.  
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,

[[Page 79157]]

coordinate comments, develop the new risk assessment, and assure that 
the necessary parties approve the new risk assessment. It is likely 
that the CMHC administrator would spend more time reviewing and working 
on the risk assessment than the other individuals. We estimate that 
complying with the proposed requirement to conduct a risk assessment 
would require 10 burden hours for a cost of $470. There are currently 
207 CMHCs. Therefore, it would require an estimated 2,070 burden hours 
(10 burden hours for each CMHC x 207 CMHCs = 2,070 burden hours) for 
all CMHCs to comply with this requirement at a cost of $97,290 ($470 
estimated cost for each CMHC x 207 CMHCs = $97,290 estimated cost).
    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 Sec.  
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 x 207 CMHCs = 3,105 burden hours) for all CMHCs to complete 
their plans at a cost of $155,250 ($750 estimated cost for each CMHC x 
207 CMHCs = $155,250 estimated cost).
    The CMHC would be required to review and update its emergency 
preparedness plan at least annually. For the purpose of determining the 
burden for this proposed requirement, we expect that the CMHCs will 
review and update their plans annually.
    We expect that all CMHCs have an administrator that is responsible 
for the day-to-day operation of the CMHC. This would include ensuring 
that all of the CMHC's plans are up-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 Sec.  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 Sec.  
485.920(b)(1) through (7).
    We expect that all CMHCs would compare their current emergency 
preparedness policies and procedures to their emergency preparedness 
plan, communication plan, and their training and testing program. They 
would need to review, revise and, if necessary, develop new policies 
and procedure to ensure they comply with the proposed requirements. The 
burden associated with reviewing, revising, and updating the CMHC's 
emergency policies and procedures would be due to the resources needed 
to ensure they comply with the proposed requirements. We expect that 
the administrator and the psychiatric registered nurse would be 
involved with reviewing, revising and, if needed, developing any new 
policies and procedures. We estimate that for a CMHC to comply with 
this proposed requirement would require 12 burden hours at a cost of 
$630. Therefore, for all 207 CMHCs to comply with this proposed 
requirement would require an estimated 2,484 burden hours (12 burden 
hours for each CMHC x 207 CMHCs = 2,484 burden hours) at a cost of 
$130,410 ($630 estimated cost for each CMHC x 207 CMHCs = $130,410 
estimated cost).
    The CMHCs would be required to review and update their emergency 
preparedness policies and procedures at least annually. For the purpose 
of determining the burden for this requirement, we expect that CMHCs 
would review their policies and procedures annually. We expect that all 
CMHCs have an administrator who is responsible for the day-to-day 
operation of the CMHC, which includes ensuring that all of the CMHC's 
policies and procedures are up-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 Sec.  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 Sec.  485.920(c)(1) through (7).
    We expect that all CMHCs would compare their current emergency

[[Page 79158]]

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 x 207 CMHCs = 1,656 burden hours) at a 
cost of $85,905 ($415 estimated cost for each CMHC x 207 CMHCs = 
$85,905 estimated cost).
    We expect that CMHCs must also review and update their emergency 
preparedness communication plan at least annually. For the purpose of 
determining the burden for this proposed requirement, we expect that 
CMHCs would review their policies and procedures annually. We expect 
that all CMHCs have an administrator who is responsible for the day-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 Sec.  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 Sec.  485.920(d)(1) and (2).
    We expect that CMHCs would develop a comprehensive emergency 
preparedness training program. The CMHCs would need to compare their 
current emergency preparedness training program and compare its 
contents to the risk assessment and updated emergency preparedness 
plan, policies and procedures, and communications plan and review, 
revise, and, if necessary, develop new sections for their training 
program to ensure it complies with the proposed requirements.
    The burden would be due to the resources the CMHC would need to 
comply with the proposed requirements. We expect that complying with 
this requirement would include the involvement of a psychiatric 
registered nurse. We expect that the psychiatric registered nurse would 
be primarily involved in reviewing the CMHC's current training program, 
determining what tasks need to be performed or what materials need to 
be developed, and developing the materials for the training program. We 
estimate that it would require 10 burden hours for each CMHC to develop 
a comprehensive emergency training program at a cost of $414. 
Therefore, it would require an estimated 2,070 burden hours (10 burden 
hours for each CMHC x 207 CMHCs = 2,070 burden hours) to comply with 
this proposed requirement at a cost of $85,698 ($414 estimated cost for 
each CMHC x 207 CMHCs = $85,698 estimated cost).
    Proposed Sec.  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 Sec.  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

[[Page 79159]]

during the drill and the exercise and for the subsequent analysis of 
the CMHC's response. The psychiatric registered nurse would also 
develop the two scenarios for the drill and exercise. We estimate that 
these tasks would require 4 burden hours at a cost of $166. For all 207 
CMHCs to comply with this proposed requirement would require an 
estimated 828 burden hours (4 burden hours for each CMHC x 207 CMHCs = 
828 burden hours) at a cost of $34,362 ($166 estimated cost for each 
CMHC x 207 CMHCs = $34,362 estimated cost).

         Table 14--Burden Hours and Cost Estimates for All 207 CMHCs To Comply With the ICRs Contained in Sec.   485.920 Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Hourly
                                                                                         Burden  per     Total      labor cost  Total labor
       Regulation  section(s)             OMB Control No.      Respondents   Responses     response      annual         of        cost of     Total cost
                                                                                           (hours)       burden     reporting    reporting       ($)
                                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   485.920(a)(1)................  0938--New..............          207          207           10        2,070           **       97,290       97,290
Sec.   485.920(a)(1)-(4)............  0938--New..............          207          207           15        3,105           **      155,250      155,250
Sec.   485.920(b)...................  0938--New..............          207          207           12        2,484           **      130,410      130,410
Sec.   485.920(c)...................  0938--New..............          207          207            8        1,656           **       85,905       85,905
Sec.   485.920(d)(1)................  0938--New..............          207          207           10        2,070           **       85,698       85,698
Sec.   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 
(Sec.  486.360)

    Proposed Sec.  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 Sec.  
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 Sec.  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 Sec.  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 x 
58 OPOs = 580 burden hours) at a cost of $47,676 ($822 estimated cost 
for each OPO x 58 OPOs = $47,676 estimated cost).
    After conducting the risk assessment, OPOs would then have to 
develop emergency preparedness plans. The burden associated with this 
requirement would be the resources needed to develop an emergency 
preparedness plan that complied with the requirements in proposed Sec.  
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 x 58 OPOs = 1,276 burden 
hours) at a cost of $102,776 ($1,772 estimated cost for each

[[Page 79160]]

OPO x 58 OPOs = $102,776 estimated cost).
    OPOs would also be required to review and update their emergency 
preparedness plans at least annually. We believe that all of the OPOs 
already review their emergency preparedness plans periodically. Thus, 
compliance with this requirement would constitute a usual and customary 
business practice for OPOs and would not be subject to the PRA in 
accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  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 Sec.  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'' (Sec.  
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 x 58 OPOs = 1,160 burden hours) at 
a cost of $85,956 (estimated cost for each OPO of $1,482 x 58 OPOs = 
$85,956 estimated cost).
    OPOs also would be required to review and update their emergency 
preparedness policies and procedures at least annually. We believe that 
OPOs already review their emergency preparedness policies and 
procedures periodically. Therefore, compliance with this requirement 
would constitute a usual and customary business practice and would not 
be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  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 
Sec.  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 x 58 OPOs = 812 burden hours) at a cost of $62,524 
($1,078 estimated cost for each OPO x 58 OPOs = $62,524 estimated 
cost).
    We propose that OPOs must review and update their emergency 
preparedness communication plans at least annually. We believe that all 
of the OPOs already review their emergency preparedness communication 
plans

[[Page 79161]]

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 Sec.  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 Sec.  
486.360(d)(1) and (2).
    In Sec.  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 (Sec.  
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 x 58 OPOs = 2,320 burden hours) at 
a cost of $139,548 ($2,406 estimated cost for each OPO x 58 OPOs = 
$139,548 estimated cost).
    We propose that OPOs must review and update their emergency 
preparedness training programs at least annually. We believe that all 
of the OPOs already review their emergency preparedness training 
programs periodically. Therefore, compliance with this requirement 
would constitute a usual and customary business practice for OPOs and 
would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  486.360(d)(2) would require OPOs to conduct a paper-
based, tabletop exercise at least annually. OPOs also would be required 
to analyze their responses to and maintain documentation of all 
tabletop exercises and actual emergency events, and revise their 
emergency plans, as needed. To comply with this requirement, OPOs would 
have to develop scenarios for each tabletop exercise and the necessary 
documentation.
    The OPO CfCs do not currently contain a requirement for OPOs to 
conduct a paper-based, tabletop exercise. However, OPOs are required to 
evaluate their staffs' performance and provide training to improve 
individual and overall staff performance and effectiveness (42 CFR 
486.326(c)). Therefore, we expect that OPOs periodically conduct some 
type of exercise to test their plans, policies, and procedures, which 
would include developing a scenario for and documenting the exercise. 
Thus, compliance with these requirements would constitute a usual and 
customary business practice and would not be subject to the PRA in 
accordance with 5 CFR 1320.3(b)(2).
    We expect that the QAPI director and the education coordinator 
would work together to develop the scenario for the exercise and the 
necessary documentation. We expect that the QAPI director would likely 
spend more time on these activities. We estimate that these tasks would 
require 5 burden hours for each OPO at a cost of $278. For all 58 OPOs 
to comply with these requirements would require an estimated 290 burden 
hours (5 burden hours for each OPO x 58 OPOs = 290 burden hours) at a 
cost of $16,124 ($278 estimated cost for each OPO x 58 OPOs = $16,124 
estimated cost).
    Proposed Sec.  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 Sec.  486.322(a), and in the protocols with 
transplant programs required under Sec.  486.344(d), the duties and 
responsibilities of the hospital, transplant program, and the OPO in 
the event of an emergency.
    The burden associated with the development of an agreement with 
another OPO and with the hospitals in the OPO's DSA would be the 
resources needed to negotiate, draft, and approve the agreement. For 
the purpose of determining a burden for this requirement, we will 
assume that each OPO would need to develop an agreement with one other 
OPO.
    We expect that the OPO director, medical director, QAPI director, 
OPC, and an attorney would be involved in completing the tasks 
necessary to develop these agreements. We expect that all of these 
individuals would be involved in assessing the OPO's need for coverage 
of its DSA during emergencies and deciding with which OPO to negotiate 
an agreement. We also expect that the OPO director, QAPI director, and 
an attorney would be involved in negotiating the agreements and 
ensuring that the appropriate parties sign the agreements. The attorney 
would be responsible for drafting the agreement and making any 
necessary revisions.
    We estimate that it would require 22 burden hours for each OPO to 
develop an agreement with another OPO to provide essential organ 
procurement services to all or a portion of its DSA during an emergency 
at a cost of $1,658. Therefore, it would require an estimated 1,276 
burden hours (22 burden hours for each OPO x 58 OPOs = 1,276 burden 
hours) for all 58 OPOs to comply with this requirement at a cost of 
$96,164 ($1,658 estimated cost for each OPO x 58 OPOs = $96,164 
estimated cost).
    Proposed Sec.  486.360(e) would also require OPOs to include in the 
agreements with hospitals required under Sec.  486.322(a), and in the 
protocols with transplant programs required under Sec.  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

[[Page 79162]]

OPOs, hospitals, and transplant centers, we expect that most, if not 
all of these agreements and protocols already address roles and 
responsibilities during an emergency.
    Thus, for the purpose of determining an ICR burden for these 
requirements, we will assume that all 58 OPOs would need to draft a 
limited amount of new language for their agreements with hospitals and 
the protocols with transplant centers. We expect that an attorney would 
be primarily responsible for drafting the language for these agreements 
and protocols and making any necessary revisions required by the 
parties. The number of hospitals and transplant programs in each DSA 
would vary widely between the OPOs. However, we expect that the 
attorney would draft standard language for both types of documents. In 
addition, we expect that the OPO director, medical director, QAPI 
director, and OPC would work with the attorney in developing this 
standard language.
    We estimate that it would require 13 burden hours for each OPO to 
comply with these requirements at a cost of $969. Therefore, it would 
require 754 burden hours (13 burden hours for each OPO x 58 OPOs = 754 
burden hours) at a cost of $56,202 ($969 estimated cost for each OPO x 
58 OPOs = $56,202 estimated cost).
    Based on the previous analysis, for all 58 OPOs to comply with all 
of the ICRs in proposed Sec.  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 Sec.   486.360 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly       Total
                                                                          Burden per     Total     labor  cost  labor  cost  Total  Capital/
    Regulation section(s)     OMB Control No.  Respondents   Responses     response      annual         of           of         Maintenance  Total  cost
                                                                           (hours)       burden     reporting    reporting     Costs  ($)         ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   486.360(a)(1)........  0938--New......           58           58           10          580           **       47,676               0       47,676
Sec.   486.360(a)(2)-(4)....  0938--New......           58           58           22        1,276           **      102,776               0      102,776
Sec.   486.360(b)...........  0938--New......           58           58           20        1,160           **       85,956               0       85,956
Sec.   486.360(c)...........  0938--New......           58           58           14          812           **       62,524               0       62,524
Sec.   486.360(d)(1)........  0938--New......           58           58           40        2,320           **      139,548               0      139,548
Sec.   486.360(d)(2)........  0938--New......           58           58            5          290           **       16,124               0       16,124
Sec.   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 
(Sec.  491.12)

    Proposed Sec.  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 Sec.  491.12(a)(1) through 
(4).
    Proposed Sec.  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'' (Sec.  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 community-
based risk assessment is only

[[Page 79163]]

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 x 4,013 RHCs = 39,410 burden hours) at a cost of 
$2,857,256 ($712 estimated cost for each RHC x 4,013 RHCs = $2,857,256 
estimated cost).
    We estimate that it would require 5 burden hours for each FQHC to 
conduct a risk assessment that complied with our proposed requirements 
at a cost of $356. We estimate that for all 5,534 FQHCs to comply would 
require 27,670 burden hours (5 burden hours for each FQHC x 5,534 FQHCs 
= 27,670 burden hours) at a cost of $1,970,104 ($356 estimated cost for 
each FQHC x 5,534 FQHCs = $1,970,104 estimated cost).
    Based on those estimates, compliance with this proposed requirement 
for all RHCs and FQHCs would require 67,800 burden hours at a cost of 
$4,827,360.
    After conducting the risk assessment, RHCs/FQHCs would have to 
develop and maintain emergency preparedness plans that complied with 
proposed Sec.  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 (Sec.  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 ``all-hazards approach'' so that these 
facilities can respond to all of the risks they identified in their 
risk assessment (Emergency Management PIN, p. 6). Based on the 
expectations in the Emergency Management PIN, we expect that FQHCs 
likely have developed emergency preparedness plans that comply with 
many, if not all, of the elements with which their plans would need to 
comply under this proposed rule. However, we expect that FQHCs would 
need to compare their current EMP to our proposed requirements and, if 
necessary, revise or develop new sections for their EMP to bring it 
into compliance. We expect that FQHCs would have less of a burden than 
RHCs.
    Based on our experience with RHCs/FQHCs, we expect that the same 
individuals who were involved in developing the risk assessments would 
be involved in developing the emergency preparedness plans. However, we 
expect that it would require more time to complete the plans than the 
risk assessments. We expect that the administrator would have primary 
responsibility for reviewing and developing the RHC/FQHC's EMP. We 
expect that the physician, nurse practitioner, and registered nurse 
would review the draft plan and provide comments to the administrator. 
We estimate that for each RHC to comply with this requirement would 
require 14 burden hours at a cost of $949. Therefore, it would require 
an estimated 56,182 burden hours (14 burden hours for each RHC x 4,013 
RHCs = 56,182 burden hours) to complete the plan at a cost of 
$3,808,337 ($949 estimated cost for each RHC x 4,013 RHCs = $3,808,337 
estimated cost).
    We estimate that it would require 8 burden hours for each FQHC to 
comply with our proposed requirements at a cost of $530. Based on that 
estimate, it would require 44,272 burden hours (8 burden hours for each 
FQHC x 5,534 FQHCs = 44,272 burden hours) to complete the plan at a 
cost of $2,933,020 ($530 estimated cost for each FQHC x 5,534 FQHCs = 
$2,933,020 estimated cost).
    Based on the previous estimates, for all RHCs and FQHCs to develop 
an emergency preparedness plan that complies with our proposed 
requirements would require 100,454 burden hours at a cost of 
$6,741,357.
    Each RHC/FQHC also would be required to review and update its 
emergency preparedness plan at least annually. We believe that RHCs and 
FQHCs already review their emergency preparedness plans periodically. 
Thus, compliance with this requirement would constitute a usual and 
customary business practice for RHCs and FQHCs and would not subject to 
the PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  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 Sec.  
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 (Sec.  491.6(c)). They also must set forth in 
writing their organization's policies (Sec.  491.7(a)(2)). In addition, 
current

[[Page 79164]]

regulations require that a physician, in conjunction with a nurse 
practitioner or physician's assistant, develop the facility's written 
policies (Sec.  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 Sec.  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 x 4,013 RHCs = 48,156 burden hours) at a cost of 
$3,884,584 ($968 estimated cost for each RHC x 4,013 RHCs = $3,884,584 
estimated cost).
    As discussed earlier, we expect that FQHCs would have less of a 
burden from developing their emergency preparedness policies and 
procedures due to the expectations set out in the Emergency Management 
PIN. Thus, we estimate that for each FQHC to comply with the proposed 
requirements would require 8 burden hours at a cost of $608. Based on 
that estimate, for all 5,534 FQHCs to comply with these requirements 
would require 44,272 burden hours (8 burden hours for each FQHC x 5,534 
FQHCs = 44,272 burden hours) at a cost of $3,364,672 ($608 estimated 
cost for each FQHC x 5,534 FQHCs = $3,364,672 estimated cost).
    Based on the previous estimates, for all RHCs and FQHCs to develop 
emergency preparedness policies and procedures that comply with our 
proposed requirements would require 92,428 burden hours at a cost of 
$7,249,256.
    We propose that RHCs/FQHCs review and update their emergency 
preparedness policies and procedures at least annually. We believe that 
RHCs and FQHCs already review their emergency preparedness policies and 
procedures periodically. Therefore, compliance with this requirement 
would constitute a usual and customary business practice for RHCs/FQHCs 
and would not be subject to the PRA in accordance with 5 CFR 
1320.3(b)(2).
    Proposed Sec.  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 Sec.  
491.12(c)(1) through (5).
    We expect that all RHCs/FQHCs have some type of emergency 
preparedness communication plan. It is standard practice for health 
care facilities to maintain contact information for staff and outside 
sources of assistance; alternate means of communication in case there 
is an interruption in the facility's phone services; and a method for 
sharing information and medical documentation with other health care 
providers to ensure continuity of care for patients. As discussed 
earlier, RHCs and FQHCs are required to take appropriate measures to 
ensure the safety of their patients during non-medical emergencies 
(Sec.  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 x 4,013 RHCs = 40,130 burden hours) 
at a cost of $3,443,154 ($734 estimated cost for each RHC x 4,013 RHCs 
= $3,443,154 estimated cost).

[[Page 79165]]

    We estimate that for a FQHC to comply with the proposed 
requirements would require 5 burden hours at a cost of $367. Based on 
this estimate, for all 5,534 FQHCs to comply would require 27,670 
burden hours (5 burden hours for each FQHC x 5,534 FQHCs = 27,670 
burden hours) at a cost of $2,030,978 ($367 estimated cost for each 
FQHC x 5,534 FQHCs = $2,030,978 estimated cost).
    We propose that RHCs/FQHCs also review and update their emergency 
preparedness communication plans at least annually. We believe that 
RHCs/FQHCs already review their emergency preparedness communication 
plans periodically. Thus, compliance with this requirement would 
constitute a usual and customary business practice for RHCs/FQHCs and 
would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  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 Sec.  
491.12(d)(1) and (2).
    Proposed Sec.  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 
(Sec.  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 x 9,547 RHCs/FQHCs = 95,470 burden 
hours) to comply with this requirement at a cost of $5,021,722 ($526 
estimated cost for each RHC/FQHC x 9,547 RHCs/FQHCs = $5,021,722 
estimated cost).
    Proposed Sec.  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 Sec.  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 x 9,547 RHCs/FQHCs = 
47,735 burden hours) at a cost of $2,634,972 ($276 estimated cost for 
each RHC/FQHC x 9,547 RHC/FQHCs = $2,634,972 estimated cost).

[[Page 79166]]



 Table 16--Burden Hours and Cost Estimates for All 9,547 RHC/FQHCS To Comply With the ICRs Contained in Sec.   491.12 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly       Total
                                                                          Burden per     Total     labor  cost  labor  cost  Total  Capital/
    Regulation section(s)     OMB Control No.  Respondents   Responses     response      annual         of           of         Maintenance  Total  cost
                                                                           (hours)       burden     reporting    reporting     Costs  ($)         ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   491.12(a)(1) (RHCs)..  0938--New......        4,013        4,013           10       40,130           **    2,857,256               0    2,857,256
Sec.   491.12(a)(1) (FQHCs).  0938--New......        5,534        5,534            5       27,670           **    1,970,104               0    1,970,104
Sec.   491.12(a)(1)-(4)       0938--New......        4,013        4,013           14       56,182           **    3,808,337               0    3,808,337
 (RHCs).
Sec.   491(a)(1)-(4) (FQHCs)  0938--New......        5,534        5,534            8       44,272           **    2,933,020               0    2,933,020
Sec.   491.12(b) (RHCs).....  0938--New......        4,013        4,013           12       48,156           **    3,884,584               0    3,884,584
Sec.   491.12(b) (FQHCs)....  0938--New......        5,534        5,534            8       44,272           **    3,364,672               0    3,364,672
Sec.   491.12(c) (RHCs).....  0938--New......        4,013        4,013           10       40,130           **    3,443,154               0    3,443,154
Sec.   491.12(c) (FQHCs)....  0938--New......        5,534        5,534            5       27,670           **    2,030,978               0    2,030,978
Sec.   491.12(d)(1).........  0938--New......        9,547        9,547           10       95,470           **    5,021,722               0    5,021,722
Sec.   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 
(Sec.  494.62)

    Proposed Sec.  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 Sec.  494.62 would 
require that the plan include the elements set out at Sec.  
494.62(a)(1) through (4).
    Proposed Sec.  494.62(a)(1) would require dialysis facilities to 
develop a documented, facility-based and community-based risk 
assessment utilizing an all-hazards approach. The risk assessment 
should address the medical and non-medical emergency events the 
facility could experience both within the facility and within the 
surrounding area. The dialysis facility would have to consider its 
location and geographical area; patient population, including, but not 
limited to, persons-at-risk; and the types of services the dialysis 
facility has the ability to provide in an emergency. The dialysis 
facility also would need to identify the measures it would need to take 
to ensure the continuity of its operations, including delegations of 
authority and succession plans.
    The burden associated with this requirement would be the resources 
needed to perform a thorough risk assessment. The current CfCs already 
require dialysis facilities to ``implement processes and procedures to 
manage medical and nonmedical emergencies that are likely to threaten 
the health or safety of the patients, the staff, or the public. These 
emergencies include, but are not limited to, fire, equipment or power 
failure, care-related emergencies, water supply interruption, and 
natural disasters likely to occur in the facility's geographic area'' 
(Sec.  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 Sec.  494.62(a). For example, the current CfCs do not require 
dialysis facilities to plan for man-made disasters. Therefore, we 
believe that all dialysis facilities would have to conduct a thorough 
review of their current risk assessments and then perform the necessary 
tasks to ensure that their facilities' risk assessments complied with 
the requirements of this section.
    Based on our experience with dialysis facilities, we expect that 
conducting the risk assessment would require the involvement of the 
dialysis facility's chief executive officer or administrator, medical 
director, nurse manager, social worker, and a PCT. We believe that all 
of these individuals would attend an initial meeting, review relevant 
sections of the current assessment, develop comments and 
recommendations for changes to the assessment, attend a follow-up 
meeting, perform a final review and approve the risk assessment. We 
believe that the administrator would probably coordinate the meetings, 
do an initial review of the current risk assessment, provide a critique 
of the risk assessment, offer suggested revisions, coordinate comments, 
develop the new risk assessment, and assure that the necessary parties 
approve the new risk assessment. We also believe that the administrator 
would probably spend more time reviewing and working on the risk 
assessment than the other individuals involved in performing the risk 
assessment. Thus, we estimate that complying with this requirement to 
conduct and develop a risk assessment would require 12 burden hours at 
a cost of $838. There are currently 5,923 dialysis facilities. 
Therefore, it would require an estimated 71,076 burden hours (12 burden 
hours for each dialysis facility x 5,923 dialysis facilities = 71,076 
burden hours) for all dialysis facilities to comply with this 
requirement at a cost of $4,963,474 ($838 estimated cost for each 
dialysis facility x 5,923 dialysis facilities = $4,963,474 estimated 
cost).
    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 Sec.  
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'' (Sec.  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'' 
(Sec.  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

[[Page 79167]]

proposed Sec.  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 x 5,923 dialysis 
facilities = 59,230 burden hours) to complete the plan at a cost of 
$4,596,248 ($776 estimated cost for each dialysis facility x 5,923 
dialysis facilities = $4,596,248 estimated cost).
    Each dialysis facility would also be required to review and update 
its emergency preparedness plan at least annually. We believe that 
dialysis facilities already review their emergency preparedness plans 
periodically. The current CfCs already requires dialysis facilities to 
evaluate the effectiveness of their emergency and disaster plans and 
update them as necessary (42 CFR 494.60(d)(4)(ii)). Thus, compliance 
with this requirement would constitute a usual and customary business 
practice and would not be subject to the PRA in accordance with 5 CFR 
1320.3(b)(2).
    Proposed Sec.  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 Sec.  494.62(a), (a)(1), and (c), respectively. 
These emergencies would include, but would not be limited to, fire, 
equipment or power failures, care-related emergencies, water supply 
interruptions, and natural and man-made disasters that are likely to 
occur in the facility's geographical area. Dialysis facilities would 
also have to review and update these policies and procedures at least 
annually. The policies and procedures would be required to address, at 
a minimum, the requirements listed at Sec.  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 x 5,923 dialysis facilities = 59,230 burden 
hours) to complete the plan at a cost of $4,596,248 ($768 estimated 
cost for each dialysis facility x 5,923 dialysis facilities = 
$4,596,248 estimated cost).
    The dialysis facility must also review and update its emergency 
preparedness policies and procedures at least annually. We believe that 
dialysis facilities already review their emergency preparedness 
policies and procedures periodically. In addition, the current CfCs 
already require (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 Sec.  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 Sec.  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

[[Page 79168]]

494.60(d)(4)). Thus, each dialysis facility should already have some of 
the contact information they would need to have in order to comply with 
this section. In addition, we expect that it is standard practice in 
the healthcare industry to have and maintain contact information for 
both staff and outside sources of assistance; alternate means of 
communications in case there is an interruption in phone service to the 
facility, such as cell phones or text-messaging devices; and a method 
for sharing information and medical documentation with other health 
care providers to ensure continuity of care for their patients. 
However, many dialysis facilities may not have formal, written 
emergency preparedness communication plans. Therefore, we expect that 
all dialysis facilities would need to review, update, and in some 
cases, develop new sections for their plans to ensure that those plans 
included all of the previously-described required elements in their 
emergency preparedness communication plan.
    The burden associated with complying with this requirement would be 
the resources required to review and revise the dialysis facility's 
emergency preparedness communication plan to ensure that it complied 
with these requirements. Based upon our experience with dialysis 
facilities, we anticipate that satisfying these requirements would 
primarily require the involvement of the dialysis facility's 
administrator, medical director, and nurse manager. For each dialysis 
facility, we estimate that complying with this requirement would 
require 4 burden hours at a cost of $357. Therefore, for all of the 
dialysis facilities to comply with this requirement would require an 
estimated 23,692 burden hours (4 burden hours for each dialysis 
facility x 5,923 dialysis facilities = 23,692 burden hours) at a cost 
of $2,114,511 ($357 estimated cost for each dialysis facility x 5,923 
dialysis facilities = $2,114,511 estimated cost).
    Each dialysis facility would also have to review and update its 
emergency preparedness communication plan at least annually. For the 
purpose of determining the burden for this requirement, we would expect 
that dialysis facilities would review their emergency preparedness 
communication plans annually. We believe that all dialysis facilities 
have an administrator that would be primarily responsible for the day-
to-day operation of the dialysis facility. This would include ensuring 
that all of the dialysis facility's policies, procedures, and plans 
were up-to-date and complied with the relevant federal, state, and 
local laws, regulations, and ordinances. We expect that the 
administrator would be responsible for periodically reviewing the 
dialysis facility's plans, policies, and procedures as part of his or 
her work responsibilities. Therefore, we expect that complying with 
this requirement would constitute a usual and customary business 
practice and would not be subject to the PRA in accordance with 5 CFR 
1320.3(b)(2).
    Proposed Sec.  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 Sec.  494.62(d)(1) through (3).
    Proposed Sec.  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 Sec.  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 x 5,923 dialysis facilities = 41,461 
burden hours) to comply with this requirement at a cost of ($559 
estimated cost for each dialysis facility x 5,923 dialysis facilities = 
$3,310,957 estimated cost).
    The dialysis facility must also review and update its emergency 
preparedness training program at least annually. We believe that 
dialysis facilities already review their emergency preparedness 
training programs periodically. Therefore, compliance with this 
requirement would constitute a usual and customary business practice 
and would not be subject to the PRA in accordance with 5 CFR 
1320.3(b)(2).
    Proposed Sec.  494.62(d)(2) requires dialysis facilities to 
participate in a mock disaster drill and conduct a paper-based, 
tabletop exercise at least annually. If a community mock disaster drill 
was not available, the dialysis facility would have to conduct an 
individual, facility-based mock disaster drill at least annually. If 
the dialysis facility experienced an actual natural or 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

[[Page 79169]]

would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Proposed Sec.  494.62(d)(3) would require dialysis facilities to 
provide appropriate orientation and training to patients, including the 
areas specified in proposed Sec.  494.62(d)(1). Proposed Sec.  
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 Sec.  
494.62(d)(1).

   Table 17--Burden Hours and Cost Estimates for All 5,923 Dialysis Facilities to Comply With the ICRs Contained in Sec.   494.62 Condition: Emergency
                                                                      Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Hourly
                                                                          Burden per     Total      labor cost  Total labor  Total  capital/
    Regulation section(s)     OMB control no.  Respondents   Responses     response      annual         of        cost of       mintenance    Total cost
                                                                           (hours)       burden     reporting    reporting      costs ($)        ($)
                                                                                        (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   494.62(a)(1).........  0938--New......        5,923        5,923           12       71,076           **    4,963,474               0    4,834,422
Sec.   494.62(a)(2)-(4).....  0938--New......        5,923        5,923           10       59,230           **    4,596,248               0    4,476,744
Sec.   494.62(b)............  0938--New......        5,923        5,923           10       59,230           **    4,596,248               0    4,476,744
Sec.   494.62(c)............  0938--New......        5,923        5,923            4       23,692           **    2,114,511               0    2,059,533
Sec.   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

[[Page 79170]]

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-for-
profit organization that is not dominant in its field; or (3) a small 
government jurisdiction with a population of less than 50,000. States 
and individuals are not included in the definition of ``small 
entity.'') HHS uses as its measure of significant economic impact on a 
substantial number of small entities a change in revenues of more than 
3 to 5 percent.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, 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 
Medicaid-participating providers and suppliers discussed in previous 
sections to perform a risk analysis; establish an emergency 
preparedness plan, emergency preparedness policies and procedures, and 
an emergency preparedness communication plan; train staff in emergency 
preparedness, and test the emergency plan. The economic impact would 
differ between hospitals

[[Page 79171]]

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) x $25.45 an hour =$152.70
     Fuel: Diesel cost of $3.85 per gallon x 72 gallon per hour 
x 4 hour of testing=$1,108.80
    Therefore, we estimate the total cost to each hospital, CAH and LTC 
facility to comply with this requirement would be $1,262. However, we 
request information on this proposal and in particular on how we might 
better estimate costs in light of the existing LSC and other state and 
federal requirements.

D. Condition of Participation: Emergency Preparedness for Religious 
Nonmedical Health Care Institutions (RNHCIs)

1. Training and Testing (Sec.  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 (Sec.  403.748(d)(2))
    Proposed Sec.  403.748(d)(2) would require RHNCIs to conduct a 
paper-based, tabletop exercise at least annually. RHNCIs must analyze 
their response and maintain documentation of all tabletop exercises, 
and emergency events, and revise their emergency plan as needed.
    We expect that the cost associated with this requirement would be 
limited to the staff time needed to participate in the tabletop 
exercises. We estimate that approximately 4 hours of staff time would 
be required of the administrator and director of nursing, and 2 hours 
of staff time for the head of maintenance to coordinate facility 
evacuations and protocols for transporting residents to alternate 
sites. We believe that other staff members would be required to spend a 
minimal amount of time during these exercises and such staff time would 
be considered a part of regular on-going training for RHNCI staff. We 
estimate that it would require 10 hours of staff time for each of the 
16 RNHCIs to conduct exercises at a cost of $330. Therefore, it would 
require an estimated

[[Page 79172]]

total impact of $5,280 each year after the initial year for all RNHCIs 
to comply with proposed Sec.  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 (Sec.  416.54(d)(2))

    Proposed Sec.  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 x 5,354 ASCs) each 
year after the first year. We estimate $15,241,036 ($2,677,000 impact 
cost + $12,564,036 ICR burden) as the total economic impact and cost 
estimates for all ASCs to comply with the requirements in this proposed 
rule.

F. Condition of Participation: Emergency Preparedness for Hospices--
Testing (Sec.  418.113(d)(2))

    Proposed Sec.  418.113(d)(2)(i) through (iii) would require 
hospices to participate in mock drills and tabletop exercises at least 
annually. In addition, hospices are to conduct a paper-based, tabletop 
exercise at least annually. We believe that the administrator would be 
responsible for participating in community-wide disaster drills and 
would be the primary person to organize a facility-wide drill and 
tabletop exercise with the assistance of one member of the IDG. We 
believe that the registered nurse would most likely represent the IDG 
on the drills and exercises. While we expect that all staff would be 
involved in the drills and exercises, we would consider their 
involvement as part of their regular staff training. However, for the 
purpose of this analysis we assume that the administrator would spend 
approximately 3 hours annually to participate in a community or 
facility-wide drill and 1 hour to participate in a tabletop exercise 
above their regular and ongoing training. We also assume that the 
registered nurse would spend 3 hours to participate in an annual drill 
and 1 hour to participate in a tabletop exercise. Thus, we estimate 
that each hospice would spend $388. The total estimate for all hospices 
to comply with this requirement after the initial year would total 
$1,463,924 ($388 x 3,773 hospices). We estimate the total economic 
impact and cost estimates for all 3,773 hospices to comply with the 
requirements in this proposed rule for the initial year would be 
$11,908,072 ($1,463,924 impact cost + $10,444,148 ICR burden).

G. Emergency Preparedness for Psychiatric Residential Treatment 
Facilities (PRTFs)--Training and Testing (Sec.  441.184(d))

    Proposed Sec.  441.184(d)(2)(i) through (iii) would require PRTFs 
to participate in a community or facility-based mock disaster drill and 
a tabletop exercise annually. We propose that if a community drill is 
not available, the PRTF would be required to conduct a facility-based 
mock disaster drill. We estimate that the cost associated with this 
requirement is the time that it would take key personnel to participate 
in the mock drill and tabletop exercise. We further estimate that the 
drill and exercise would involve the administrator and registered nurse 
to spend about 4 hours each on an annual basis to participate (3 hours 
to participate in a community or facility-wide drill and 1 hour to 
participate in a table-top drill). Thus, we anticipate that complying 
with this requirement would require 4 hours for the administrator and 4 
hours for the registered nurse at a combined estimated cost of $360 per 
facility. The total annual cost for all 387 PRTFs would be $139,320. 
The total cost for the first year to comply with the requirement would 
be $1,071,990 ($139,320 impact cost + $932,670 ICR burden).

H. Emergency Preparedness for Program for the All-Inclusive Care for 
the Elderly (PACE) Organizations--Training and Testing (Sec.  
460.84(d))

    Proposed Sec.  460.84(d)(2)(i) through (iii) would require PACE 
organizations to conduct a mock community or facility-wide drill and a 
paper-based, tabletop exercise annually. Since PACE organizations are 
currently required to conduct a facility-wide drill annually, we are 
only estimating economic impact for the annual tabletop drill. We 
expect that both the home-care coordinator and the quality-improvement 
nurse would each spend 1 hour to conduct the tabletop exercise. Thus, 
we estimate the economic impact hours to be 2 hours for each PACE 
organization (total impact hours = 182) at an estimated cost of $90 for 
each organization. The total annual cost for all PACE organizations is 
$8,190 ($90 x 91 providers). The total cost for all PACE organizations 
to comply with the requirements in the first year would be $342,888 
($8,190 impact cost + $334,698 ICR burden).

I. Condition of Participation: Emergency Preparedness for Hospitals

1. Medical Supplies (Sec.  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.

[[Page 79173]]

    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 (Sec.  482.15(d)(1))
    Proposed Sec.  482.15(d)(1) would require hospitals to develop and 
maintain an emergency preparedness training program and review and 
update it at least annually. Based on our experience with health care 
facilities, we expect that all health care facilities provide some type 
of training to all personnel, including those providing services under 
contract or arrangement and volunteers. Since such training is required 
for the TJC-accredited hospitals, the proposed requirements for 
developing an emergency preparedness-training program and the materials 
they plan to use in providing initial and on-going annual training 
would constitute a usual and customary business practice for TJC-
accredited hospitals.
    However, under this proposed rule, non TJC-accredited hospitals 
would need to review their existing training program and appropriately 
revise, update, or develop new sections and new material for their 
training program. The economic impact associated with this requirement 
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 (Sec.  482.15(d)(2)(i) through (iii))
    Proposed Sec.  482.15(d)(2)(i) through (iii) would require 
hospitals to participate in or conduct a mock disaster drill and a 
paper-based, tabletop exercise at least annually.
    State, tribal, territorial, and local public health and medical 
systems comprise a critical infrastructure that is integral in 
providing early recognition and response necessary for minimizing the 
effects of catastrophic public health and medical emergencies. 
Educating and training these clinical, laboratory, and public health 
professionals has been, and continues to be, a top priority for the 
federal government. There are currently four programs at HHS addressing 
education and training in the area of public health emergency 
preparedness and response. The programs are the Centers for Public 
Health Preparedness (CPHP), The Bioterrorism Training and Curriculum 
Development Program (BTCDP), and National Laboratory Training Network 
(NLTN). As discussed earlier in this preamble, hospitals can use these 
and other resources, such as tools offered by the DHS, to assist them 
in complying with this proposed requirement. Thus, for non-TJC 
accredited hospitals, the costs associated with this requirement would 
be primarily due to the staff time needed to participate in the 
community-wide and facility-based disaster drills, and the tabletop 
exercises. We believe that appreciable staff time would be required of 
the risk management director, facilities director, safety director, and 
security manager. We expect that other staff members would be required 
to spend a minimal amount of time during these exercises, which would 
be considered a part of regular on-going training for hospital staff. 
We estimate that the risk management director, facilities director, 
safety director and security manager would spend about 12 hours each (8 
hours for a disaster drill and 4 hours for a tabletop exercise) on an 
annual basis to meet the proposed requirement.
    Thus, we have estimated the economic impact for the 1,518 non-TJC 
accredited hospitals. We anticipate that complying with this 
requirement would require 48 hours for an estimate of $3,360 for each 
non TJC-accredited hospital. Therefore, for all non TJC-accredited 
hospitals to comply with this requirement would require 72,864 total 
economic impact hours (48 economic impact hours per non TJC-accredited 
hospital x 1,518 non TJC-accredited hospitals = 72,864 total economic 
impact hours) at an estimated total cost of $5,100,480 ($3,360 per non 
TJC-accredited hospital x 1,518 hospitals = $5,100,480).
    Based on TJC's standards, the TJC-accredited hospitals are 
currently required to test their emergency operations plan twice a 
year. Therefore, for TJC-accredited hospitals to conduct disaster 
drills and tabletop exercises would constitute a usual and customary 
business practice and we will not include this activity in the economic 
impact analysis.
4. Generator Testing (Sec.  482.15(e))
    Section Sec.  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 x $25.45/hr ($152.70) x 869 non-accredited hospitals). We 
estimate fuel cost to be $963,547 (72 gallon/hr x $3.85/gallon x 4 
hours ($1,108.80) x 869

[[Page 79174]]

non-accredited hospitals) for non-accredited hospitals. Thus for non-
accredited hospitals, we estimate the total cost to comply with this 
requirement to be $1,096,243.
    For accredited hospitals, we estimate labor cost to be $413,206 (2 
(6 hours x $25.45/hr)/3 ($101.80)) x 4,059 accredited hospitals). We 
estimate fuel cost to be $3,000,413 (2 (72 gallon/hr x $3.85/gallon x 4 
hours)/3 ($739.2)) x 4,059 accredited hospitals) for accredited 
hospitals. Thus for accredited hospitals, we estimate the total cost to 
comply with this requirement to be $3,413,619.
    Therefore, the total economic impact of this rule on hospitals 
would be $39,265,594 ($5,100,480 disaster drills impact cost + 
$4,509,862 generator impact cost + $29,655,252 ICR burden).

J. Condition of Participation: Emergency Preparedness for Transplant 
Centers

    There is no additional economic impact to discuss in this section 
for transplant centers. All transplant centers are located within a 
hospital and, thus, would not have to stockpile supplies in an 
emergency or conduct a mock disaster drill or a tabletop exercise.

K. Emergency Preparedness Long Term Care (LTC) Facilities

1. Subsistence (Sec.  483.73(b)(1))
    Section Sec.  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 (Sec.  483.73(d))
    Section Sec.  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 (Sec.  483.73(e))
    Proposed Sec.  483.73(e) would require LTC facilities to test each 
emergency generator for a minimum of 4 continuous hours at least once 
every 12 months. We estimate labor cost to be $2,314,474 (6 hours x 
$25.45/hr ($152.70) x 15,157 LTC facilities). We estimate fuel cost to 
be $16,806,082 (72 gallon/hr x $3.85/gallon x 4 hours ($1,108.80) x 
15,157 facilities). Therefore, we anticipate that complying with this 
requirement would cost an estimated $19,120,556.

L. Condition of Participation: Emergency Preparedness for Intermediate 
Care Facilities for Individuals with Intellectual Disabilities (ICFs/
IID)

1. Testing (Sec.  483.475(d)(2))
    Proposed Sec.  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. Sec.  484.22 Condition of Participation: Emergency Preparedness for 
Home Health Agencies (HHAs)--Training and Testing (Sec.  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 Sec.  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

[[Page 79175]]

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 (Sec.  485.68(d)(2)(i) through (iii))

    Proposed Sec.  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 (Sec.  485.625(d)(2))
    Proposed Sec.  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 x 920 non-accredited CAH) at an estimated 
total cost of $1,041,440 ($1,132 x 920).
2. Generator Testing (Sec.  485.625(e))
    Proposed Sec.  485.625(e) would require CAHs to test each emergency 
generator for a minimum of 4 continuous hours at least once every 12 
months. AO's, including TJC, DNV, and HFAP; currently require 
accredited CAHs to test their generators/emergency power supply system 
once for 4 continuous hours every 36 months. Therefore, the cost of the 
existing testing requirement was deducted from the cost calculation for 
accredited CAHs. However, under this proposed rule, non-accredited CAHs 
would be required to run their emergency generators an additional 4 
hours, with an additional 1 hour for preparation, and an additional 1 
hour for restoration.
    For non-accredited CAHs, we estimate labor cost to be $139,721 (6 
hours x $25.45/hr ($152.70) x 915 non-accredited CAHs). We estimate 
fuel cost to be $1,014,552 (72 gallon/hr x $3.85/gallon x 4 hours 
($1,108.80) x 915 non-accredited CAHs) for non-accredited CAHs. Thus 
for non-accredited CAHs, we estimate the total cost to comply with this 
requirement to be $1,154,273.
    For accredited CAHs, we estimate labor cost to be $41,433 (2 (6 
hours x $25.45/hr)/3 ($101.80)) x 407 accredited CAHs). We estimate 
fuel cost to be $300,854 (2 (72 gallon/hr x $3.85/gallon x 4 hours)/3 
($739.2)) x 407 accredited CAHs) for accredited CAHs. Thus for 
accredited CAHs, we estimate the total cost to comply with this 
requirement to be $342,287.
    Therefore, the total economic impact of this rule on CAHs would be 
$8,339,742 ($1,041,440 disaster drills impact cost + $1,496,560 
generator impact cost + $5,801,742 ICR burden).

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 (Sec.  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 (Sec.  485.920(d))

    Proposed Sec.  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 x 207 CMHCs) total economic impact hours at a 
total estimated cost of $85,905 ($415 x 207 CMHCs). Therefore, the 
total economic impact of this rule on CMHCs would be $674,820 ($85,905 
impact cost + $588,915 ICR burden).

[[Page 79176]]

R. Conditions of Participation: Emergency Preparedness for Organ 
Procurement Organizations (OPOs)--Training and Testing (Sec.  
486.360(d)(2)(i) through (iii))

    The OPO CfCs do not currently contain a requirement for OPOs to 
conduct mock disaster drills or paper-based, tabletop exercises. We 
estimate that these tasks would require the quality assessment and 
performance improvement (QAPI) director and the education coordinator 
to each spend 1 hour to participate in the tabletop exercise. Thus, the 
total annual economic impact hours for each OPO would be 2 hours. The 
total cost would be $107 for a (QAPI coordinator hourly salary and the 
Education Coordinator to participate in the tabletop exercise. The 
economic impact for all OPOs would be 116 (2 impact hours x 58 OPOs) 
total economic impact hours at an estimated cost of $6,206 ($107 x 58 
OPOs). Therefore, the total economic impact of this rule on OPOs would 
be $613,176 ($6,206 impact cost + $606,970 ICR burden).

S. Emergency Preparedness: Conditions for Certification for Rural 
Health Clinics (RHCs) and Conditions for Coverage for Federally 
Qualified Health Clinics (FQHCs)

1. Training and Testing (Sec.  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 (Sec.  491.12(d)(2)(i) through (iii))
    Proposed Sec.  491.12(d)(2)(i) through (iii) would require RHCs/
FQHCs to participate in a community or facility-wide mock disaster 
drill and a tabletop exercise at least annually. We have stated 
previously that FQHCs are currently required to conduct annual drills. 
We believe that for FQHCs to comply with these requirements would 
constitute a minimal economic impact, if any. Thus, we are estimating 
the economic impact for RHCs to comply with these requirements to 
conduct mock drills and tabletop exercises. We estimate that a RHCs 
administrator would spend 4 hours annually to participate in the 
disaster drills. Also, we estimate that a nurse coordinator (registered 
nurse) would each spend 4 hours on an annual basis to participate in 
the disaster drills (3 hours to participate in a community or facility-
wide drill and 1 hour to participate in a table-top drill). Thus, we 
anticipate that complying with this requirement would require 8 hours 
for each RHC for an estimated cost of $452 per facility. The total 
annual cost for 4,013 RHCs would be $1,813,876. Therefore, the total 
economic impact of this rule on RHCs/FQHCs would be $33,762,675 
($1,813,876 impact cost + $31,948,799 ICR burden).

T. Condition of Participation: Emergency Preparedness for End-Stage 
Renal Disease Facilities (Dialysis Facilities)--Testing (Sec.  
494.62(d)(2)(i) through (iv))

    Proposed Sec.  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 (Sec.  494.60(d)(4)(ii)). Thus, we expect that all 
dialysis facilities are already conducting some type of tests to 
evaluate their emergency plans. Although the current CfCs do not 
specify the type of drill or test, we believe that dialysis facilities 
are currently participating in community or facility-wide drills. 
Therefore, for the purpose of this impact analysis, we estimate that 
dialysis facilities would need to add the tabletop exercise to their 
emergency preparedness activities. We estimate that it would require 1 
hour each for the administrator (hourly wage of $74.00) and the nurse 
manager (hourly wage of $64.00) to conduct the annual tabletop 
exercise. Thus, for the 5,923 dialysis facilities to comply with the 
proposed requirements for conducting tabletop exercises, we estimate 
11,846 economic impact hours. We estimate the total cost to be $138 for 
each facility, with a total economic impact of $817,374 ($138 x 5,923 
facilities). Therefore, the total economic impact of this rule on ESRD 
facilities would be $20,398,812 ($817,374 impact cost + $19,581,438 ICR 
burden).

U. Summary of the Total Costs

    The following is a summary of the total providers and the annual 
cost estimates for all providers to comply with the requirements in 
this rule.

 Table 18--Total Annual Cost To Participate in Disaster Drills and Test
                     Generators Across the Providers
------------------------------------------------------------------------
                                             Number of      Total cost
                Facility                   participants       (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
------------------------------------------------------------------------


[[Page 79177]]

    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
----------------------------------------------------------------------------------------------------------------
                                                                                                 Total cost  in
                                                                Number of      Total cost  in      year 2  and
                         Facility                             participants     year 1  (in $)    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

[[Page 79178]]

disruptions following an emergency or disaster. A 2008 study concluded 
that many Hurricane Katrina survivors with mental disorders experienced 
unmet treatment needs, including frequent disruptions of existing care 
and widespread failure to initiate treatment for new-onset disorders 
(Wang, P.S., et.al. ``Disruption of Existing Mental Health Treatments 
and Failure to Initiate New Treatment After Hurricane Katrina. American 
Journal of Psychiatry, 165(1), 34-41)'' (2006).
    Hospital closures during Sandy resulted in up to a 25 percent 
increase in emergency department visits at numerous centers in New York 
and a 70-percent increase in ambulance traffic. A proportion of this 
increase was due to populations being unable to receive routine care. 
Not only do vulnerable populations experience disruptions in care, they 
may also incur increased costs for care, especially when those who 
require ongoing medical treatment during disasters are required to 
visit emergency departments for treatment and/or hospitalization. 
Emergency department visits incur a copay for most beneficiaries. 
Similar costs are also incurred by patients for hospitalizations. The 
literature shows that natural catastrophes disproportionately affect 
ill and socioeconomically disadvantaged populations that are most at 
risk (Abdel-Kader K, Unrah ML. Disaster and end-stage renal disease: 
targeting vulnerable patients for improved outcomes. Kidney Int. 
2009;75:1131-1133; Zoraster R, Vanholder R, Sever MS. Disaster 
management of chronic dialysis patients. Am J Disaster Med. 
2007;2(2):96-106; and Redlener I, Reilly M. Lessons from Sandy--
Preparing Health Systems for Future Disasters. N ENGL J MED. 
367;24:2269-2271).
    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
------------------------------------------------------------------------
                                                          Number of FFS
                     Provider type                          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

[[Page 79179]]

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-Hospitals-2012.cfm) of ASPR's Hospital Preparedness Program (HPP) 
showed that disaster preparedness was not identified as a top issue. We 
believe that absent conditions of participation/certification/coverage, 
providers and suppliers would not consistently adhere to the various 
local, state and federal emergency preparedness requirements. Moreover, 
many such instructions are unclear as to what is mandatory or only 
strongly recommended, and written in ways that leave compliance 
difficult or impossible to determine consistently across providers. 
Such inconsistent application of local, state, and federal requirements 
could compound the problems faced by governments, health care 
organizations, and citizens during a disaster. In 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

[[Page 79180]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                       Units
                    Category                         Estimates   -----------------------------------------------
                                                                    Year dollar    Discount rate  Period covered
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
Qualitative.....................................  Help ensure the safety of individuals by requiring providers
                                                  and suppliers to adequately plan for and respond to both
                                                  natural and man-made disasters.
----------------------------------------------------------------------------------------------------------------
                                                     Costs *
----------------------------------------------------------------------------------------------------------------
Annualized 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

0
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).

[[Page 79181]]

Sec.  403.742  [Amended]

0
2. Amend Sec.  403.742 by:
0
A. Removing paragraphs (a)(1), (4), and (5).
0
B. Redesignating paragraphs (a)(2) and (3) as paragraphs (a)(1) and 
(2), respectively.
0
C. Redesignating paragraphs (a)(6) through (8) as paragraphs (a)(3) 
through (5), respectively.
0
3. Add Sec.  403.748 to subpart G to read as follows:


Sec.  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 at-risk; the type of services the RNHCI has the ability to 
provide in an emergency; and, continuity of operations, including 
delegations of authority and succession plans.
    (4) Include a process for ensuring cooperation and collaboration 
with local, tribal, regional, State, and Federal emergency preparedness 
officials' efforts to ensure an integrated response during a disaster 
or emergency situation, including documentation of the RNHCI's efforts 
to contact such officials and, when applicable, of its participation in 
collaborative and cooperative planning efforts.
    (b) Policies and procedures. The RNHCI must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least annually. At a minimum, the policies and 
procedures must address the following:
    (1) The provision of subsistence needs for staff and patients, 
whether they evacuate or shelter in place, include, but are not limited 
to the following:
    (i) Food, water, and supplies.
    (ii) Alternate sources of energy to maintain the following:
    (A) Temperatures to protect patient health and safety and for the 
safe and sanitary storage of provisions.
    (B) Emergency lighting.
    (C) Fire detection, extinguishing, and alarm systems.
    (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, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (ii) Analyze the RNHCI's response to and maintain documentation of 
all tabletop exercises, and emergency events, and revise the RNHCI's 
emergency plan, as needed.

[[Page 79182]]

PART 416--AMBULATORY SURGICAL SERVICES

0
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).


Sec.  416.41  [Amended]

0
5. Amend Sec.  416.41 by removing paragraph (c).
0
6. Add Sec.  416.54 to subpart C to read as follows:


Sec.  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, facility-based mock disaster 
drill for 1 year following the onset of the actual event.
    (iii) Conduct a paper-based, tabletop exercise at least annually. A 
tabletop exercise is a group discussion led by a facilitator, using a 
narrated, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (iv) Analyze the ASC's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events and revise the 
ASC's emergency plan, as needed.

[[Page 79183]]

PART 418--HOSPICE CARE

0
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.


Sec.  418.110  [Amended]

0
8. Amend Sec.  418.110 by removing paragraph (c)(1)(ii) and by removing 
the paragraph designation (i) from paragraph (c)(1)(i).
0
9. Add Sec.  418.113 to subpart D to read as follows:


Sec.  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

[[Page 79184]]

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, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (iv) Analyze the hospice's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events, and revise the 
hospice's emergency plan, as needed.

PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC 
SERVICES

0
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).

0
11. Add Sec.  441.184 to subpart D to read as follows:


Sec.  441.184  Emergency preparedness.

    The Psychiatric Residential Treatment Facility (PRTF) must comply 
with all applicable Federal and State emergency preparedness 
requirements. The PRTF must establish and maintain an emergency 
preparedness program that meets the requirements of this section. The 
emergency preparedness program must include, but not be limited to, the 
following elements:
    (a) Emergency plan. The PRTF must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least annually. 
The plan must do the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified 
by the risk assessment.
    (3) Address resident population, including, but not limited to, 
persons at-risk; the type of services the PRTF has the ability to 
provide in an emergency; and continuity of operations, including 
delegations of authority and succession plans.
    (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

[[Page 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, facility-based mock 
disaster drill for 1 year following the onset of the actual event.
    (iii) Conduct a paper-based, tabletop exercise at least annually. A 
tabletop exercise is a group discussion led by a facilitator, using a 
narrated, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (iv)(A) Analyze the PRTF's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events.
    (B) Revise the PRTF's emergency plan, as needed.

PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)

0
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)).


Sec.  460.72  [Amended]

0
13. Amend Sec.  460.72 by removing paragraph (c).
0
14. Add Sec.  460.84 to subpart E to read as follows:


Sec.  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.

[[Page 79186]]

    (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 man-
made emergency that requires activation of the emergency plan, the PACE 
organization is exempt from engaging in a community or individual, 
facility-based mock disaster drill for 1 year following the onset of 
the actual event.
    (iii) Conduct a paper-based, tabletop exercise at least annually. A 
tabletop exercise is a group discussion led by a facilitator, using a 
narrated, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (iv) Analyze the PACE's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events and revise the 
PACE's emergency plan, as needed.

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
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.

0
16. Add Sec.  482.15 to subpart B to read as follows:


Sec.  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 at-risk; the type of services the hospital has the ability to 
provide in an emergency; and continuity of operations, including 
delegations of authority and succession plans.
    (4) Include a process for ensuring cooperation and collaboration 
with local, tribal, regional, State, and Federal emergency preparedness 
officials' efforts to ensure an integrated response during a disaster 
or emergency situation, including documentation of the hospital's 
efforts to contact such officials and, when applicable, its 
participation in collaborative and cooperative planning efforts.
    (b) Policies and procedures. The hospital must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least annually. At a minimum, the policies 
and procedures must address the following:
    (1) The provision of subsistence needs for staff and patients, 
whether they evacuate or shelter in place, include, but are not limited 
to the following:
    (i) Food, water, and medical supplies.
    (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.

[[Page 79187]]

    (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, clinically-relevant 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.
0
17. Add Sec.  482.78 to subpart E to read as follows:


Sec.  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 Sec.  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

0
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).

0
19. Add Sec.  483.73 to subpart B to read as follows:


Sec.  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 at-risk; the type of services the LTC facility has the ability 
to provide in an emergency; and continuity of operations, including 
delegations of authority and succession plans.
    (4) Include a process for ensuring cooperation and collaboration 
with local, tribal, regional, State, or Federal emergency preparedness 
officials' efforts to ensure an integrated response during a disaster 
or emergency situation, including documentation of the LTC facility's 
efforts to contact such officials and, when applicable, of its

[[Page 79188]]

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, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (iv) Analyze the LTC facility's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the LTC facility's emergency plan, as needed.
    (e) Emergency and standby power systems. The LTC facility must 
implement emergency and standby power systems based on the emergency 
plan set forth in paragraph (a) of this section.
    (1) Emergency generator location. (i) The generator must be located 
in accordance with the location requirements found in NFPA 99 and NFPA 
100.
    (2) Emergency generator inspection and testing. In addition to the 
emergency power system inspection and testing requirements found in 
NFPA 99--Health Care Facilities and NFPA 110--Standard for Emergency 
and Standby Power Systems, as referenced by NFPA 101--Life Safety Code 
as required under paragraph (a) of this section, the LTC facility must 
do the following:
    (i) At least once every 12 months test each emergency generator for 
a minimum of 4 continuous hours. The emergency generator test load must 
be 100 percent of the load the LTC facility anticipates it will require 
during an emergency.
    (ii) Maintain a written record, which is available upon request, of 
generator

[[Page 79189]]

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.


Sec.  483.75  [Amended]

0
20. Amend Sec.  483.75 by removing and reserving paragraph (m).


Sec.  483.470  [Amended]

0
21. Amend Sec.  483.470 by--
0
A. Removing paragraph (h).
0
B. Redesignating paragraphs (i) through (l) as paragraphs (h) through 
(k), respectively.
0
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)''.
0
22. Add Sec.  483.475 to subpart I to read as follows:


Sec.  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 Sec.  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.

[[Page 79190]]

    (iii) Maintain documentation of the training.
    (iv) Ensure that staff can demonstrate knowledge of emergency 
procedures.
    (2) Testing. The ICF/IID must conduct exercises to test the 
emergency plan. The ICF/IID must do the following:
    (i) Participate in a community mock disaster drill at least 
annually. If a community mock disaster drill is not available, conduct 
an individual, facility-based mock disaster drill at least annually.
    (ii) If the ICF/IID experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the ICF/IID 
is exempt from engaging in a community or individual, facility-based 
mock disaster drill for 1 year following the onset of the actual event.
    (iii) Conduct a paper-based, tabletop exercise at least annually. A 
tabletop exercise is a group discussion led by a facilitator, using a 
narrated, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (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

0
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.

0
24. Add Sec.  484.22 to subpart B to read as follows:


Sec.  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 Sec.  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

[[Page 79191]]

plan, the HHA is exempt from engaging in a community or individual, 
facility-based mock disaster drill for 1 year following the onset of 
the actual event.
    (iii) Conduct a paper-based, tabletop exercise at least annually. A 
tabletop exercise is a group discussion led by a facilitator, using a 
narrated, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (iv) Analyze the HHA's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
HHA's emergency plan, as needed.

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

0
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)).


Sec.  485.64  [Removed]

0
26. Remove Sec.  485.64.
0
27. Add Sec.  485.68 to subpart B to read as follows:


Sec.  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, facility-based mock 
disaster drill for 1 year following the onset of the actual event.
    (iii) Conduct a paper-based, tabletop exercise at least annually. A 
tabletop exercise is a group discussion led by a facilitator, using a 
narrated, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (iv) Analyze the CORF's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CORF's emergency plan, as needed.

[[Page 79192]]

Sec.  485.623  [Amended]

0
28. Amend Sec.  485.623 by removing paragraph (c) and redesignating 
paragraph (d) as paragraph (c).
0
29. Add Sec.  485.625 to subpart F to read as follows:


Sec.  485.625  Condition of participation: Emergency preparedness.

    The Critical Access Hospital (CAH) must comply with all applicable 
Federal and State emergency preparedness requirements. The CAH must 
develop and maintain a comprehensive emergency preparedness program, 
utilizing an all-hazards approach. The emergency preparedness plan must 
include, but not be limited to, the following elements:
    (a) Emergency plan. The CAH must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least annually. 
The plan must:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach;
    (2) Include strategies for addressing emergency events identified 
by the risk assessment;
    (3) Address patient population, including, but not limited to, 
persons at-risk; the type of services the CAH has the ability to 
provide in an emergency; and continuity of operations, including 
delegations of authority and succession plans.
    (4) Include a process for ensuring cooperation and collaboration 
with local, tribal, regional, State, and Federal emergency preparedness 
officials' efforts to ensure an integrated response during a disaster 
or emergency situation, including documentation of the CAH's efforts to 
contact such officials and, when applicable, of its participation in 
collaborative and cooperative planning efforts.
    (b) Policies and procedures. The CAH must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least annually. At a minimum, the policies and 
procedures must address the following:
    (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, facility-based mock disaster 
drill for 1 year following the onset of the actual event.
    (iii) Conduct a paper-based, tabletop exercise at least annually. A 
tabletop exercise is a group discussion led by a facilitator, using a 
narrated, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions

[[Page 79193]]

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.
0
30. Revise Sec.  485.727 to read as follows:


Sec.  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

[[Page 79194]]

exercise is a group discussion led by a facilitator, using a narrated, 
clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (iv) Analyze the Organization's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise their emergency plan, as needed.
0
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::


Sec.  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, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (iv) Analyze the CMHC's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CMHC's emergency plan, as needed.

[[Page 79195]]

PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED 
BY SUPPLIERS

0
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).

0
33. Add Sec.  486.360 to subpart G to read as follows:


Sec.  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, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (ii) Analyze the OPO's response to and maintain documentation of 
all tabletop exercises, and emergency events, and revise the OPO's 
emergency plan, as needed.
    (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 Sec.  486.322(a) and in the protocols with transplant 
programs required under Sec.  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

0
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).


Sec.  491.6  [Amended]

0
35. Amend Sec.  491.6 by removing paragraph (c).
0
36. Add Sec.  491.12 to read as follows:


Sec.  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

[[Page 79196]]

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, clinically-relevant 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

0
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).


Sec.  494.60  [Amended]

0
38. Amend Sec.  494.60 by--
0
A. Removing paragraph (d).
0
B. Redesignating paragraph (e) is as paragraph (d).
0
39. Add Sec.  494.62 to subpart B to read as follows:


Sec.  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

[[Page 79197]]

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, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (iv) Analyze the dialysis facility's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the dialysis facility's emergency plan, as needed.
    (3) Patient orientation. Emergency preparedness patient training. 
The facility must provide appropriate orientation and training to 
patients, including the areas specified in paragraph (d)(1) of this 
section.

(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


[[Page 79198]]



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, capabilities-based approach to preparedness. It 
requires the development of a National Preparedness Goal, a national 
system description, a national planning system that features the 5 
integrated national planning frameworks for prevention, protection, 
response, recovery and mitigation and federal interagency 
operational plans (FIOPS). This directive can be found at http://www.dhs.gov/presidential-policy-directive-8-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-influenza-implementation.htm. Resources for Healthcare Providers and Suppliers 
for Responding to Pandemic Influenza:
     ``One-step access to U. S. Government h1N1, Avian, and 
Pandemic Flu Information'' 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''

[[Page 79199]]

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-risk-report0901.pdf.
     An August 30, 2005 article in the Health Affairs 
publication by Dausey, D., Lurie, N., and Diamond, A, entitled, 
``Public Health Response to Urgent Case Reports,'' evaluated the 
ability of local public health agencies (LPHAs) to adequately meet 
``a preparedness standard'' set 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)

[[Page 79200]]

 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