[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Rules and Regulations]
[Pages 63860-64044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21404]



[[Page 63859]]

Vol. 81

Friday,

No. 180

September 16, 2016

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; Final Rule

  Federal Register / Vol. 81 , No. 180 / Friday, September 16, 2016 / 
Rules and Regulations  

[[Page 63860]]


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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-F]
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: Final rule.

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SUMMARY: This final rule establishes national emergency preparedness 
requirements for Medicare- and Medicaid-participating providers and 
suppliers to plan adequately for both natural and man-made disasters, 
and coordinate with federal, state, tribal, regional, and local 
emergency preparedness systems. It will also assist providers and 
suppliers to adequately prepare to meet the needs of patients, 
residents, clients, and participants during disasters and emergency 
situations. Despite some variations, our regulations will provide 
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: Effective date: These regulations are effective on November 15, 
2016.
    Incorporation by reference: The incorporation by reference of 
certain publications listed in the rule is approved by the Director of 
the Federal Register November 15, 2016.
    Implementation date: These regulations must be implemented by 
November 15, 2017.

FOR FURTHER INFORMATION CONTACT: 
    Janice Graham, (410) 786-8020.
    Mary Collins, (410) 786-3189.
    Diane Corning, (410) 786-8486.
    Kianna Banks (410) 786-3498.
    Ronisha Blackstone, (410) 786-6882.
    Alpha-Banu Huq, (410) 786-8687.
    Lisa Parker, (410) 786-4665.

SUPPLEMENTARY INFORMATION:

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/HFAP American Osteopathic Association/Healthcare Facilities 
Accreditation Program
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
CON Certificate of Need
CfCs Conditions for Coverage and Conditions for Certification
CHAP Community Health Accreditation Program
CMHC Community Mental Health Center
CMS Centers for Medicare and Medicaid Services
COI Collection of Information
CoPs Conditions of Participation
CORF Comprehensive Outpatient Rehabilitation Facilities
CPHP Centers for Public Health Preparedness
CRI Cities Readiness Initiative
DHS Department of Homeland Security
DHHS Department of Health and Human Services
DNV GL Det Norske Veritas GL--Healthcare
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
ESAR-VHP Emergency System for Advance Registration of Volunteer 
Health Professionals
ESF Emergency Support Function
ESRD End-Stage Renal Disease
FEMA Federal Emergency Management Agency
FDA Food and Drug Administration
FORHP Federal Office of Rural Health Policy
FRI Federal Reserve Inventories
FQHC Federally Qualified Health Center
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 or Assessment
ICFs/IID Intermediate Care Facilities for Individuals with 
Intellectual Disabilities
ICR Information Collection Requirements
IDG Interdisciplinary Group
IOM Institute of Medicine
JPATS Joint Patient Assessment and Tracking System
LEP Limited English Proficiency
LD Leadership
LPHA Local Public Health Agencies
LSC Life Safety Code
LTC Long Term Care
MMRS Metropolitan Medical Response System
MRC Medical Reserve Corps
MS Medical Staff
NDMS National Disaster Medical System
NFs 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
PACE Program for the All-Inclusive Care for the Elderly
PAHPA Pandemic and All-Hazards Preparedness Act
PAHPRA Pandemic and All-Hazards Preparedness Reauthorization Act
PCT Patient Care Technician
PPE Personal Protection Equipment
PHEP Public Health Emergency Preparedness
PHS Act Public Health Service Act
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
RNHCIs 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
TRACIE Technical Resources, Assistance Center, and Information 
Exchange

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TTX Tabletop Exercise
UMRA Unfunded Mandates Reform Act
UNOS United Network for Organ Sharing
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
    C. Statutory and Regulatory Background
II. Provisions of the Proposed Rule and Responses to Public Comments
    A. General Comments
    1. Integrated Health Systems
    2. Requests for Technical Assistance and Funding
    3. Requirement To Track Patients and Staff
    B. Implementation Date
    C. Emergency Preparedness Regulations for Hospitals (Sec.  
482.15)
    1. Risk Assessment and Emergency Plan (Sec.  482.15(a))
    2. Policies and Procedures (Sec.  482.15(b)
    3. Communication Plan (Sec.  482.15(c)
    4. Training and Testing (Sec.  482.15(d)
    5. Emergency Fuel and Generator Testing (Sec.  482.15(e)
    D. Emergency Preparedness Regulations for Religious Nonmedical 
Health Care Institutions (RNHCIs) (Sec.  403.748)
    E. Emergency Preparedness Regulations for Ambulatory Surgical 
Centers (ASCs) (Sec.  416.54)
    F. Emergency Preparedness Regulations for Hospices (Sec.  
418.113)
    G. Emergency Preparedness Regulations for Psychiatric 
Residential Treatment Facilities (PRTFs) (Sec.  441.184)
    H. Emergency Preparedness Regulations for Programs of All-
Inclusive Care for the Elderly (PACE) (Sec.  460.84)
    I. Emergency Preparedness Regulations for Transplant Centers 
(Sec.  482.78)
    J. Emergency Preparedness Regulations for Long-Term Care (LTC) 
Facilities (Sec.  483.73)
    K. Emergency Preparedness Regulations for Intermediate Care 
Facilities for Individuals With Intellectual Disabilities (ICF/IID) 
(Sec.  483.475)
    L. Emergency Preparedness Regulations for Home Health Agencies 
(HHAs) (Sec.  484.22)
    M. Emergency Preparedness Regulations for Comprehensive 
Outpatient Rehabilitation Facilities (CORFs) (Sec.  485.68)
    N. Emergency Preparedness Regulations for Critical Access 
Hospitals (CAHs) (Sec.  485.625)
    O. Emergency Preparedness Regulations for Clinics, 
Rehabilitation Agencies, and Public Health Agencies as Providers of 
Outpatient Physical Therapy and Speech-Language Pathology Services 
(Organizations) (Sec.  485.727)
    P. Emergency Preparedness Regulations for Community Mental 
Health Centers (CMHCs) (Sec.  485.920)
    Q. Emergency Preparedness Regulations for Organ Procurement 
Organizations (OPOs) (Sec.  486.360)
    R. Emergency Preparedness Regulations for Rural Health Clinics 
(RHCs) and Federally Qualified Health Centers (FQHCs) (Sec.  491.12)
    S. Emergency Preparedness Regulations for End-Stage Renal 
Disease (ESRD) Facilities (Sec.  494.62)
III. Provisions of the Final Regulations
    A. Changes Included in the Final Rule
    B. Incorporation by Reference
IV. Collection of Information
V. Regulatory Impact Analysis
VI. Waiver of Proposed Rulemaking

I. Overview

A. Executive Summary

1. Purpose
    We have reviewed existing Medicare emergency regulatory 
preparedness requirements for both providers and suppliers. We found 
that many providers and suppliers have emergency preparedness 
requirements, but those requirements do not go far enough in ensuring 
that these providers and suppliers are equipped and prepared to help 
protect those they serve during emergencies and disasters. Hospitals, 
for example, are currently required to have emergency power and 
lighting in some specified areas and there must be facilities for 
emergency gas and water supply. We believe that these existing 
requirements are generally insufficient in the face of the needs of the 
patients, staff and communities, and do not address inconsistency in 
the level of emergency preparedness amongst healthcare providers. For 
example, while some accreditation organizations have standards that 
exceed CMS' current requirements for hospitals by requiring them to 
conduct a risk assessment, there are other providers and suppliers who 
do not have any emergency preparedness requirements, such as Community 
Mental Health Centers (CMHCs) and Psychiatric Residential Treatment 
Facilities (PRTFs). We concluded that current emergency preparedness 
requirements are not comprehensive enough to address the complexities 
of the actual emergencies. 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, the 2009 H1N1 
influenza pandemic, tornadoes and floods in the spring of 2011, and 
Hurricane Sandy in 2012, our nation's health security and readiness for 
public health emergencies have been on the national agenda. This final 
rule issues emergency preparedness requirements that establish a 
comprehensive, consistent, flexible, and dynamic regulatory approach to 
emergency preparedness and response that incorporates the lessons 
learned from the past, combined with the proven best practices of the 
present. We recognize that central to this approach is to develop and 
guide emergency preparedness and response within the framework of our 
national healthcare system. To this end, these requirements 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.
2. Summary of the Major Provisions
    We are issuing emergency preparedness requirements that will be 
consistent and enforceable for all affected Medicare and Medicaid 
providers and suppliers (referred to collectively as ``facilities,'' 
throughout the remainder of this final rule where applicable). This 
final rule addresses the three key essentials we believe are necessary 
for maintaining access to healthcare services during emergencies: 
safeguarding human resources, maintaining 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 emergency planning: We are requiring 
facilities to perform a risk assessment that uses an ``all-hazards'' 
approach prior to establishing an emergency plan. The all-hazards risk 
assessment will be used to identify the essential components to be 
integrated into the facility emergency plan. 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 or supplier and considers the particular 
types of hazards most likely to occur in their areas. These may 
include, but are not limited to, care-related emergencies; equipment 
and power failures; interruptions in communications, including cyber-
attacks; loss of a portion or all of a

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facility; and, interruptions in the normal supply of essentials, such 
as water and food. Additional information on the emergency preparedness 
cycle can be found at the Federal Emergency Management Agency (FEMA) 
National Preparedness System Web site located at: https://www.fema.gov/threat-and-hazard-identification-and-risk-assessment.
     Policies and procedures: We are requiring that facilities 
develop and implement policies and procedures that support the 
successful execution of the emergency plan and risks identified during 
the risk assessment process.
     Communication plan: We are requiring facilities 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 healthcare providers, and with state and 
local public health departments and emergency management agencies and 
systems to protect patient health and safety in the event of a 
disaster. The following link is to FEMA's comprehensive preparedness 
guide to develop and maintain emergency operations plans: https://www.fema.gov/media-library-data/20130726-1828-25045-0014/cpg_101_comprehensive_preparedness_guide_developing_and_maintaining_emergency_operations_plans_2010.pdf. During an emergency, it is critical 
that hospitals, and all providers/suppliers, 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 facilities and to ensure that these functions 
are carried out in a safe and effective manner.
     Training and testing: We are requiring that a facility 
develop and maintain an emergency preparedness training and testing 
program. A well-organized, effective training program must include 
initial training for new and existing staff in emergency preparedness 
policies and procedures as well as annual refresher trainings. The 
facility must offer annual emergency preparedness training so that 
staff can demonstrate knowledge of emergency procedures. The facility 
must also conduct drills and exercises to test the emergency plan to 
identify gaps and areas for improvement. The Homeland Security Exercise 
and Evaluation Program (HSEEP), developed by FEMA, includes a section 
on the establishment of a Training and Exercise Planning Workshop 
(TEPW). The TEPW section provides guidance to organizations in 
conducting an annual TEPW and developing a Multi-year Training and 
Exercise Plan (TEP) in line with the (HSEEP): http://www.fema.gov/media-library-data/20130726-1914-25045-8890/hseep_apr13_.pdf.

B. Current State of Emergency Preparedness

    As previously discussed, numerous natural and man-made disasters 
have challenged the United States over the past several years. 
Disasters can disrupt the environment of healthcare and change the 
demand for healthcare services; therefore, it is essential that 
healthcare facilities integrate emergency management into their daily 
functions and values. On December 27, 2013, we published a proposed 
rule titled, ``Medicare and Medicaid Programs; Emergency Preparedness 
Requirements for Medicare and Medicaid Participating Providers and 
Suppliers'' (78 FR 79082). In this proposed rule we included a robust 
discussion about the current state of emergency preparedness and 
federal emergency preparedness activities that have established a 
foundation for the development and expansion of healthcare emergency 
preparedness systems. In addition, the December 2013 proposed rule 
included an appendix of the numerous resources and documents used to 
develop the proposed rule. We refer readers to the proposed rule for 
this background information.
    The December 2013 proposed rule included discussion of previous 
events, such as the 2009 H1N1 influenza pandemic, the 2001 anthrax 
attacks, the tornados in 2011 and 2012, and Hurricane Sandy in 2012. In 
2014, the United States faced a number of new and emerging diseases, 
such as MERS-CoV and Ebola, and a nationwide outbreak of Enterovirus 
D68, which was confirmed in 938 people in 46 states between mid-August 
and October 21, 2014 (http://www.cdc.gov/non-polio-enterovirus/outbreaks/EV-D68-outbreaks.html). We believe that finalizing the 
emergency preparedness rule is an important part of improving the 
national response to Ebola and any infectious disease threats. 
Healthcare providers have raised concerns about their safety when 
caring for patients with Ebola, citing the need for advanced 
preparation, effective policies and procedures, communication plans, 
and sufficient training and testing, particularly for personal 
protection equipment (PPE). The response highlighted the importance of 
establishing written procedures, protocols, and policies ahead of an 
emergency event. With the finalization of the emergency preparedness 
rule, this type of planning will be mandated for Medicare and Medicaid 
participating hospitals and other providers and suppliers through the 
conditions of participation (CoPs) and conditions for coverage (CfCs) 
established by this rule.

C. Statutory and Regulatory Background

    Various sections of the Social Security Act (the Act) define the 
types of providers and suppliers that may participate in Medicare and 
Medicaid and list the requirements that each provider and supplier must 
meet to be eligible for Medicare and Medicaid participation. The Act 
also authorizes the Secretary to establish other requirements as 
necessary to protect the health and safety of patients, although the 
wording of such authority differs slightly between provider and 
supplier types. Such requirements may include the CoPs for providers, 
CfCs for suppliers, and requirements for long-term care facilities. The 
CoPs and CfCs are intended to protect public health and safety and 
promote high quality care for all persons. Furthermore, the Public 
Health Service (PHS) Act sets forth additional regulatory requirements 
that certain Medicare providers and suppliers are required to meet in 
order to participate.
    The following are the statutory and regulatory citations for the 
providers and suppliers for which we are issuing 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 416.2 and 416.40 through 416.52.
     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 Residential Treatment Facilities (PRTFs)--
sections1905(a) and 1905(h) of the Act and 42 CFR 441.150 through 
441.182 and 42 CFR 483.350 through 483.376.
     Programs of All-Inclusive Care for the Elderly (PACE)--
sections 1894, 1905(a), and 1934 of the Act and 42 CFR 460.2 through 
460.210.
     Hospitals--section 1861(e)(9) of the Act and 42 CFR 482.1 
through 482.66.
     Transplant Centers--sections 1861(e)(9) and 1881(b)(1) of 
the Act and 42 CFR 482.68 through 482.104.
     Long Term Care (LTC) Facilities--Skilled Nursing 
Facilities (SNFs)--under section 1819 of the Act, Nursing Facilities 
(NFs)--under section 1919 of the Act, and 42 CFR 483.1 through 483.180.

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     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.
    The proposed rule responded to concerns from the Congress, the 
healthcare community, and the public regarding the ability of 
healthcare facilities to plan and execute appropriate emergency 
response procedures for disasters. In the proposed rule, we 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 emergency planning; (2) 
policies and procedures; (3) communication plan; and (4) training and 
testing. We proposed that these core components be used across provider 
and supplier types as diverse as hospitals, organ procurement 
organizations, and home health agencies, while attempting to tailor 
requirements for individual provider and supplier types to meet their 
specific needs and circumstances, as well as the needs of their 
patients, residents, clients, and participants. These proposals are 
refined and adopted in this final rule.

II. Provisions of the Proposed Rule and Responses to Public Comments

    In response to our December 2013 proposed rule, we received nearly 
400 public comments. Commenters included individuals, healthcare 
professionals and corporations, national associations, health 
departments and emergency management professionals, and individual 
facilities that would be impacted by the regulation. Most comments 
centered around the hospital requirements, but could be applied to the 
additional provider and supplier types. We also received comments 
specific to the requirements we proposed for other individual provider 
and supplier types. In addition, we solicited comments on specific 
issues. We have organized our responses to the comments as follows: (1) 
General comments; (2) implementation date; (3) comments specific to 
hospitals and those that apply to the overall requirements of the 
regulation; and (4) comments specific to other providers and suppliers.

A. General Comments

    We received the following comments suggesting improvement to our 
regulatory approach or requesting clarification of the resources used 
to develop our proposals:
    Comment: Most commenters supported our proposal to require Medicare 
and Medicaid participating facilities to establish an emergency 
preparedness plan. Many of these commenters noted that this proposal is 
timely and necessary in light of past emergencies and natural 
disasters.
    Response: We thank the commenters for their support. We continue to 
believe that our current regulations for Medicare and Medicaid 
providers and suppliers do not adequately address emergency 
preparedness planning and that emergency preparedness CoPs for 
providers and CfCs for suppliers should be implemented at this time.
    Comment: Several commenters disagreed with our proposal to 
establish emergency preparedness requirements for Medicare and Medicaid 
providers and suppliers. Some commenters were concerned that this 
proposal would place undue burden and financial strain on facilities. 
Most of these commenters stated that it would be difficult to implement 
additional regulations without additional payment through Medicare, 
Medicaid, or the Hospital Preparedness Program (HPP). The commenters 
also stated that facilities would need more time to comply with the 
proposed requirements.
    A few commenters disagreed with our statement that hospitals should 
have emergency preparedness plans and stated that hospitals are already 
prepared for emergencies. A commenter objected to the statement that 
hospital leadership has not prioritized disaster preparedness.
    A commenter recommended that the proposed emergency preparedness 
requirements be reduced and simplified to reflect the minimum 
requirements that each provider type is expected to meet. Other 
commenters objected to the entire proposal and the establishment of 
additional regulations for healthcare facilities.
    Response: We disagree with the commenters who stated that the 
emergency preparedness regulations are inappropriate or unnecessary. 
Healthcare facilities in the United States have faced many challenges 
over the years including hurricanes, tornados, floods, wild fires, and 
pandemics. Facilities that do not have plans established prior to an 
emergency or a disaster may face difficulties providing continuity of 
care for their patients. In addition, without proper training, 
healthcare workers may find it difficult to implement emergency 
preparedness plans during an emergency or a disaster.
    Upon review of the current emergency preparedness requirements for 
providers and suppliers participating in Medicare and Medicaid, we 
concluded that the current requirements are not comprehensive enough to 
address the complexities of actual emergencies. We believe that, 
currently, in the event of a disaster, healthcare facilities across the 
nation will not have the necessary emergency planning and preparation 
in place to adequately protect the health and safety of their patients. 
In addition, we believe that the current regulatory patchwork of 
federal, state, and local laws and guidelines, combined with various 
accrediting organizations' emergency preparedness standards, falls far 
short of what is needed for healthcare facilities to be adequately 
prepared for a disaster. Therefore, we proposed to establish 
comprehensive, consistent, and flexible emergency preparedness 
regulations that incorporate lessons learned from the past with the 
proven best practices of the present. Finalizing these proposals, with 
the modifications discussed later in this final rule, will help 
healthcare facilities be better prepared in case of a disaster or 
emergency. We note that the majority of the comments to the proposed 
rule agree with the establishment of some type of regulatory

[[Page 63864]]

framework for emergency preparedness planning, which further supports 
our position that establishing emergency preparedness regulations is 
the most appropriate course of action.
    In response to comments that request additional time for compliance 
or additional funds, we refer readers to the discussion on the 
implementation date and further discussions on funding in this final 
rule.
    Comment: Some commenters stated that the term ``ensure'' was used 
numerous times in the proposed rule and that the term was over-used. 
Commenters stated that in some circumstances we stated providers and 
suppliers had to ``ensure'' elements of the plan that might be beyond 
their control during an emergency. A commenter suggested that we 
replace the word ``ensure'' with the term ``strive to achieve.''
    Response: We used the word ``ensure'' or ``ensuring'' to convey 
that each provider and supplier will be held accountable for complying 
with the requirements in this rule. However, to avoid any ambiguity, we 
have removed the term ``ensure'' and ``ensuring'' from the regulation 
text of all providers and suppliers and have addressed the requirements 
in a more direct manner.
    Comment: Some commenters were concerned that the proposed emergency 
preparedness requirements duplicate existing requirements by The Joint 
Commission (TJC). TJC is a CMS-approved accrediting organization that 
has standards and survey procedures that meet or exceed those used by 
CMS and state surveyors. Facilities accredited under a Medicare 
approved accreditation program, such as TJC's, may be ``deemed'' by CMS 
to be in compliance with the CoPs. Most of these commenters recommended 
that CMS rely on existing TJC standards. Other commenters noted that 
CMS used TJC manual citations from 2007 through 2008. The commenters 
noted that changes have been made since then and recommended that CMS 
refer to the most recent TJC manual.
    Response: We discussed TJC standards in the proposed rule as a 
point of reference for emergency preparedness standards that currently 
exist for healthcare facilities, absent additional federal regulations. 
We note that CMS has the authority to create and modify CoPs, which 
establish the requirements a provider must meet to participate in the 
Medicare or Medicaid program. Also, we note that facilities that exceed 
CMS's requirements will still remain compliant.
    Comment: A few commenters stated that the proposal did not take 
into account the differences that exist between individual facilities. 
The commenters noted that the proposal does not acknowledge the 
diversity of different facilities and instead requires a ``one size 
fits all'' emergency preparedness plan. The commenters recommended that 
CMS address the variation between facilities in the emergency 
preparedness requirements.
    Some commenters stated that the proposed requirements are 
inappropriate because they mostly apply to hospitals, and cannot be 
applied to other healthcare settings. A commenter noted that smaller 
hospitals with limited capabilities, like LTCHs, should be allowed to 
work with their local emergency response networks to develop emergency 
preparedness plans that reflect those hospitals' limitations.
    Response: We believe our approach, with the changes to our proposal 
discussed later in this final rule, appropriately addresses the 
differences between the 17 provider and supplier types covered by these 
regulations. We believe that emergency preparedness regulations that 
are too specific may become outdated over time, as technology and the 
nature of threats change, and that emergency preparedness regulations 
that are too broad may be ineffective. Therefore, we proposed four main 
components that are consistent with the principles as set forth in the 
National Preparedness Cycle contained within the National Preparedness 
System (link (see: https://www.fema.gov/national-preparedness-system) 
that can be used across diverse healthcare settings, while tailoring 
specific requirements for individual provider and supplier types based 
on their needs and circumstances, as well as the needs and 
circumstances of their patients, residents, clients, and participants. 
We continue to believe that these four components, and the variations 
in the specific requirements of these components, appropriately address 
variation amongst provider and supplier settings and facilities with an 
appropriate amount of flexibility. We do not believe that we have taken 
a ``one size fits all'' approach in these regulations.
    We agree with the commenter who stated that smaller hospitals 
should be allowed to work with their local health department and 
emergency management agency to develop emergency preparedness plans and 
we encourage these facilities to engage in healthcare coalitions in 
their area for assistance in meeting these requirements. However, we 
note that we are not mandating that smaller facilities confer with 
local emergency response networks while developing their emergency 
preparedness plans.
    Comment: A few commenters stated that the proposed provisions were 
too specific and detailed. Some commenters believed that, like other 
CoPs, the proposal should include provisions that are more flexible. 
The commenters noted that more specificity should be included in CMS' 
interpretive guidance documents (IGs).
    Response: We disagree with commenters. We believe that these 
regulations strike a balance between the specific and the general. We 
have not prescribed or mandated specific technology or tools, nor have 
we included detailed requirements for how emergency preparedness plans 
should be written. The regulations are broad enough that facilities can 
formulate an effective emergency preparedness plan, based on a 
facility-based and community-based risk assessment utilizing an all-
hazards approach, that includes appropriate policies and procedures, a 
communication plan, and training and testing. In meeting the emergency 
preparedness requirements, providers can tailor specific details to 
their facilities' and their patients' needs. Facilities can also exceed 
the requirements in this final rule, if they believe it is in their 
patients' and their facilities' interests to do so.
    Comment: A few commenters suggested that CMS require facilities to 
include other entities, stakeholders, and individuals in their 
emergency preparedness planning. Specifically, a few commenters 
suggested that facilities include patients, their family members, and 
vulnerable populations, including older adults, people with 
disabilities, and those who are linguistically isolated, in their 
emergency preparedness planning. A few commenters also recommended that 
facilities include patients and their families in emergency 
preparedness education. A few commenters recommended that front line 
workers and their workers' unions be included in the emergency 
preparedness planning. A commenter suggested that CMS emphasize the 
full continuum of emergency management activities and identify relevant 
national associations and resources for each provider type.
    A commenter noted that local emergency management officials are 
rarely included in emergency planning. The commenter recommended adding 
a requirement that would require facilities to submit their emergency 
preparedness plan to their local emergency management agency for review 
and assessment, and for assistance on sheltering and evacuation 
procedures.

[[Page 63865]]

    Response: In the proposed rule, we proposed to require certain 
facilities to develop a method for sharing information from the 
emergency plan that the facility determines is appropriate with 
patients/residents and their families or representatives. A facility 
may choose to involve other entities in the development of an emergency 
preparedness plan or they can provide emergency preparedness education 
to patients' families and caregivers. During the development of the 
emergency plan, facilities may also choose to include patients, 
community members and others in the process. However, we are not 
mandating these actions as we believe such a requirement would impose 
an excessive burden on providers and suppliers; instead, we encourage 
and will allow facilities the discretion to confer with entities and 
resources that they consider appropriate while creating an emergency 
preparedness plan and strongly encourage that facilities include 
individuals with disabilities and others with access and functional 
needs in their planning.
    Comment: A commenter recommended that emergency preparedness plans 
should account for children's special needs during an emergency. The 
commenter stated that emergency preparedness plans should include 
children's medication and medical device needs, challenges regarding 
patient transfer for neonatal and pediatric intensive care patients, 
and issues involving behavioral health and family reunification.
    A commenter recommended that CMS collaborate closely with the 
Emergency Medical Services for Children (EMSC) program administered by 
the Health Resources and Services Administration (HRSA). The commenter 
noted that this program focuses on improving the pediatric components 
of the EMS system.
    Response: We appreciate the commenter's concerns. As required in 
Sec.  482.15(a)(1), (2), and (3), when a provider or supplier develops 
an emergency preparedness plan, we will expect that the provider/
supplier will use a facility-based and community-based risk assessment 
to develop a plan that addresses that facility's patient population, 
including at-risk populations. If the provider serves children, or if 
the majority of its patient population is children, as is the case for 
children's hospitals, we will expect the provider to take into account 
children's access and functional needs during an emergency or disaster 
in its emergency preparedness plan.
    Comment: A few commenters questioned CMS' definition of an 
emergency. A commenter disagreed with the proposed rule's definition of 
``emergency'' and ``disaster.'' The commenter stated that the proposed 
rule definitions exclude internal or smaller disasters that a hospital 
may declare. Furthermore, the commenter noted that the definitions 
should include mass casualty incidents and internal emergencies or 
disasters that a facility may declare. Another commenter requested 
clarification as to whether the regulation applies to external or 
internal emergencies.
    Response: In the proposed rule, we defined an ``emergency'' or 
``disaster'' 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. However, we agree with the commenter's observation that 
the definition of an ``emergency'' or ``disaster'' should include 
internal emergency or disaster events. Therefore, we clarify our 
statement that an ``emergency'' or ``disaster'' is an event that can 
affect the facility internally as well as the overall target population 
or the community at large.
    We believe that hospitals should have a single emergency plan that 
addresses all-hazards, including internal emergencies and a man-made 
emergency (or both) or natural disaster. Hospitals have the discretion 
to determine when to activate their emergency plan and whether to apply 
their emergency plan to internal or smaller emergencies or disasters 
that may occur within their facilities. We encourage hospitals to 
prepare for all-hazards that may affect their patient population and 
apply their emergency preparedness plans to any emergency or disaster 
that may arise. Furthermore, we encourage hospitals that may be dealing 
with an internal emergency or disaster to maintain communication with 
external emergency preparedness entities and other facilities where 
appropriate.
    Comment: A few commenters were concerned that the proposed rule did 
not require planning for recovery of operations. The commenters 
recommended that CMS include requirements for facilities to plan for 
the return of normal operations after an emergency. A commenter 
recommended that CMS include requirements for provider preparedness in 
case of an information technology (IT) system failure.
    Response: We understand the commenter's concerns and believe that 
facilities should consider planning for recovery of operations during 
the emergency or disaster response. Recovery of operations will require 
that facilities coordinate efforts with the relevant health department 
and emergency management agencies to restore facilities to their 
previous state prior to the emergency or disaster event. Our new 
emergency preparedness requirements focus on continuity of operations, 
not recovery of operations. Facilities can choose to include recovery 
of operations planning in their emergency preparedness plan, but we 
have not made recovery of operations planning a requirement.
    We refer commenters that are interested in recovery of operations 
planning to the following resources for more information:
     National Disaster Recovery Framework (NDRF): https://www.fema.gov/national-disaster-recovery-framework.
     Continuity Guidance Circular 1 (CGC 1), and Continuity 
Guidance for Non-Federal Entities (States, Territories, Tribal, and 
Local Government Jurisdictions and Private Sector Organizations) http://www.fema.gov/pdf/about/org/ncp/cont_guidance1.pdf.
     National Preparedness System (https://www.fema.gov/national-preparedness-system)
     Comprehensive Preparedness Guide 101 http://www.fema.gov/media-library-data/20130726-1828-25045-0014/cpg_101_comprehensive_preparedness_guide_developing_and_maintaining_emergency_operations_plans_2010.pdf)
    Comment: A commenter requested clarification on whether hospitals 
would have direct access to the Emergency System for Advance 
Registration of Volunteer Health Professionals (ESAR-VHP).
    A commenter recommended that CMS work with other federal agencies, 
including the Department of Homeland Security (DHS) and the Federal 
Emergency Management Agency (FEMA) to expand ESAR-VHP and Medical 
Reserve Corps (MRC) team deployments to a 3 month rotation basis. The 
commenter also recommended that CMS purchase and pre-position Federal 
Reserve Inventories (FRI) at healthcare distributorships.
    Response: Hospitals do not have direct access to the Emergency 
System for Advance Registration of Volunteer Health Professional (ESAR-
VHP). The Assistant Secretary for Preparedness

[[Page 63866]]

and Response (ASPR) manages the ESAR-VHP program. The program is 
administered on the state level. A hospital would request volunteer 
health professionals through State Emergency Management. For more 
information, reviewers may email ASPR at [email protected] or visit the 
ESAR/VHP Web site: http://www.phe.gov/esarvhp/pages/home.aspx. 
Volunteer deployments typically last for 2 weeks and are not extended 
without the agreement of the volunteer.
    In regards to the comment on the Federal Reserve Inventories, we 
believe that the commenter may be referring to the Strategic National 
Stockpile (SNS). The SNS program is a national repository of 
antibiotics, chemical antidotes, antitoxins, life-support medications, 
and medical supplies. It is not within CMS' purview to purchase, 
administer, or maintain SNS stock. We refer commenters who have 
questions about the SNS program to the Centers for Disease Control and 
Prevention (CDC) Web site at http://emergency.cdc.gov/stockpile/index.asp.
    Comment: A commenter noted that CMS did not include emergency 
preparedness requirements for transport units (fire and rescue units, 
and ambulances). Furthermore, the commenter questioned whether a 
Certificate of Need (CON) is necessary during an emergency.
    Another commenter questioned why large single specialty and 
multispecialty medical groups are not discussed as included or excluded 
in this rule. The commenter noted that these entities have Medicare and 
Medicaid provider status; therefore, should be included in this rule. 
Another commenter questioned whether the proposed regulations would 
apply to residential drug and alcohol treatment centers. The commenter 
noted that if this is the case, it would be difficult for these centers 
to meet the proposed requirements due to lack of funding.
    Response: The emergency preparedness requirements only pertain to 
the 17 provider and supplier types discussed previously in this rule, 
which have existing CoPs or CfCs. These provider and supplier types do 
not include fire and rescue units, and ambulances, or single-specialty/
multi-specialty medical groups. Entities that work with hospitals or 
any of the other provider and supplier types covered by this regulation 
may have a role in the provider's or supplier's emergency preparedness 
plan, and providers or suppliers may choose to consider the role of 
these entities in their emergency preparedness plan. In addition, we 
note that CMS does not exercise regulatory authority over drug and 
alcohol treatment centers.
    In response to the question about a Certificate of Need, we note 
that facilities must formulate an emergency preparedness plan that 
complies with state and local laws. A Certificate of Need is a document 
that is needed in some states and local jurisdiction before the 
creation, acquisition, or expansion of a facility is allowed. 
Facilities should check with their state and local authorities in 
regards to Certificate of Need requirements.
    Comment: A commenter requested clarification on a facility's 
responsibility to patients that have already evacuated the facility on 
their own.
    Response: Facilities are required to track the location of staff 
and patients in the facility's care during an emergency. The facility 
is not required to track the location of patients who have voluntarily 
left on their own, since they are no longer in the facility's care. 
However, if a patient voluntarily leaves a facility's care during an 
emergency or a disaster, the facility may choose to inform the 
appropriate health department and emergency management or emergency 
medical services authorities if it believes the patient may be in 
danger.
    Comment: A commenter questioned whether the requirements take into 
account the role of the physician during emergency preparedness 
planning. The commenter questioned whether physicians will be required 
to provide feedback during the planning process, whether physicians 
would have a role in preserving patient medical documentation, whether 
physicians would be involved in determining arrangements for patients 
during a cessation of operations, and to what extent physicians would 
be required to participate in training and testing.
    Response: Individual physicians are not required, but are 
encouraged, to develop and maintain emergency preparedness plans. 
However, physicians that work in a facility that is required to develop 
and maintain an emergency preparedness plan can and are encouraged to 
provide feedback or suggestions for best practices. In addition, 
physicians that are employed by the facility and all new and existing 
staff must participate in emergency preparedness training and testing. 
We have not mandated a specific role for physicians during an emergency 
or disaster event, but we expect facilities to delineate 
responsibilities for all of their facility's workers in their emergency 
preparedness plans and to determine the appropriate level of training 
for each professional role.
    Comment: A commenter objected to use of the term ``volunteers'' in 
the proposed rule. The commenter stated that this term was not defined 
and recommended that the proposal be limited to healthcare 
professionals used to address surge needs during an emergency. Another 
commenter recommended that the regulation text should be revised to 
include the language, ``Use of health care volunteers'', to further 
clarify this distinction.
    Response: We provided information on the use of volunteers in the 
proposed rule (78 FR 79097), specifically with reference to the Medical 
Reserve Corps and the ESAR-VHP programs. Private citizens or medical 
professionals not employed by a hospital or facility often offer their 
voluntary services to hospitals or other entities during an emergency 
or disaster event. Therefore, we believe that facilities should have 
policies and procedures in place to address the use of volunteers in an 
emergency, among other emergency staffing strategies. We believe such 
policies should address, among other things, the process and role for 
integration of healthcare professionals that are locally-designated, 
such as the Medical Reserve Corps (https://www.medicalreservecorps.gov/HomePage), or state-designated, such as Emergency System for Advance 
Registration of Volunteer Health Professional (ESAR-VHP), (http://www.phe.gov/esarvhp/pages/home.aspx) that have assisted in addressing 
surge needs during prior emergencies. As with previous emergencies, 
facilities may choose to utilize assistance from the MRC or through the 
state ESAR-VHP program. We believe the description of healthcare 
volunteers is already included in the current requirement and does not 
need to be further defined.
    Comment: A commenter questioned if the proposal will require 
facilities to plan for an electromagnetic event. The commenter noted 
that protecting against and treating patients after an electromagnetic 
event is costly.
    Another commenter recommended that the rule explicitly include and 
address the threats of fire, wildfires, tornados, and flooding. The 
commenter notes that these scenarios are not included in the National 
Planning Scenarios (NPS).
    Response: We expect facilities to develop an emergency preparedness 
plan that is based on a facility-based and community-based risk 
assessment using an ``all-hazards'' approach. If a provider or supplier 
determines that its facility or community is at risk for an

[[Page 63867]]

electromagnetic event or natural disasters, such as fires, wildfires, 
tornados, and flooding, the provider or supplier can choose to 
incorporate planning for such an event into its emergency preparedness 
plan. We note that compliance with these requirements, including a 
determination of whether the provider or supplier based its emergency 
preparedness plan on facility-based and community-based risk 
assessments using an all-hazards approach, will be assessed through on-
site surveys by CMS, State Survey Agencies, or Accreditation 
Organizations with CMS-approved accreditation programs.
    Comment: A few commenters had recommendations for the structure and 
organization of the proposed rule. A commenter recommended that CMS 
specify the 17 providers and supplier types to which the rule would 
apply in the first part of the rule, so that facilities could verify 
whether or not the regulations would apply to them. A few commenters 
suggested that the requirements of the proposed rule should not be 
included in the CoPs, but instead comprise a separate regulatory 
chapter specific to emergency preparedness.
    Response: We included a list of the provider and supplier types 
affected by the emergency preparedness requirements in the proposed 
rule's Table of Contents (78 FR 79083 through 79084) and in the 
preamble text 78 FR 79090. Thus, we believe that we clearly listed the 
affected providers and suppliers at the very beginning of the proposed 
rule.
    We also believe the emergency preparedness requirements should be 
included in the CoPs for providers, the CfCs for suppliers, and 
requirements for LTC facilities. These CoPs, CfCs, and requirements for 
LTC facilities are intended to protect public health and safety and 
ensure that high quality care is provided to all persons. Facilities 
must meet their respective CoPs, CfCs, or requirements in order to 
participate in the Medicare and Medicaid programs. We are able to 
enforce and monitor compliance with the CoPs, CfCs, and requirements 
for LTC facilities through the survey process. Therefore, we believe 
that the emergency preparedness requirements are included in the most 
appropriate regulatory chapters.
    Comment: A few commenters suggested additional citations for the 
proposed rule, recommended that we include specific reference material, 
and suggested edits to the preamble language. A commenter stated that 
we omitted some references in the preamble discussion of the proposed 
rule. The commenter noted that while we included references to HSPD 5, 
21, and 8 in the proposed rule, the commenter recommended that all of 
the HSPDs should have been included. Furthermore, the commenter noted 
that HSPD 7 in particular, which does not provide a specific role for 
HHS, should have been referenced since it includes discussion of 
critical infrastructure protection and the role it plays in all-hazards 
mitigation.
    A commenter suggested that we add the following text to section 
II.B.1.a. of the proposed rule (78 FR 79085): ``HSPD-21 tasked the 
establishment of the National Center for Disaster Medicine and Public 
Health (http://ncdmph.usuhs.edu) as an academic center of excellence at 
the Uniformed Services University of the Health Sciences to lead 
federal efforts in developing and propagating core curricula, training, 
and research in disaster health.''
    A commenter recommended that we include the Joint Guidelines for 
Care of Children in the Emergency Department, developed by the American 
Academy of Pediatrics, the American College of Emergency Physicians, 
and the Emergency Nurses Association, as a resource for the final rule.
    A commenter suggested the addition of the phrase ``private critical 
infrastructure'' to the following statement on page 79086 of the 
proposed rule: ``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.''
    A commenter included several articles and referenced documentation 
on emergency preparedness and proper management and disposal of medical 
waste materials, while another recommended that CMS reference specific 
FEMA reference documents. Another commenter referred CMS to the 
Comprehensive Preparedness Guidelines 101 Template, although the 
commenter did not specify the source of this template.
    Response: We thank the commenters for their recommended edits 
throughout the document. The editorial suggestions are appreciated and 
noted. We also want to thank commenters for their recommendations for 
additional resources on emergency preparedness. We provided an 
extensive list of resources in the proposed and have included links to 
various resources in this final rule that facilities can use as 
resources during the development of their emergency preparedness plans. 
However, we note that these lists are not comprehensive, since we 
intend to allow facilities flexibility as they implement the emergency 
preparedness requirements. We encourage facilities to use any resources 
that they find helpful as they implement the emergency preparedness 
requirements. Omissions from the list of resources set out in the 
proposed rule do not indicate any intention on our part to exclude 
other resources from use by facilities.
    Comment: A commenter stated that the local emergency management and 
public health authorities are the best-placed entities to coordinate 
their communities' disaster preparedness and response, collaborating 
with hospitals as instrumental partners in this effort.
    Response: We stated in the proposed rule that local emergency 
management and public health authorities play a very important role in 
coordinating their community's disaster preparedness and response 
activities. We proposed that each hospital develop an emergency plan 
that includes 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. We also proposed that hospitals participate in 
community mock disaster drills. As noted in the proposed rule, we 
believe that community-wide coordination during a disaster is vital to 
a community's ability to maintain continuity of healthcare for the 
patient population during and after a disaster or emergency.
    Comment: A few commenters were concerned about the exclusion of 
specific requirements to account for the health and safety of 
healthcare workers. A commenter, in reference to pediatric healthcare, 
recommended that we consider adding a behavioral healthcare provision 
to the emergency preparedness requirements, which would account for the 
professional self-care needs of healthcare providers. Another commenter 
suggested that we change the language on page 79092 of the proposed 
rule to include 5 phases of emergency management, with the addition of 
the phrase ``protection of the safety and security of occupants in the 
facility.'' Another commenter recommended that we include occupational 
health and safety elements in the four proposed emergency preparedness 
standards. Furthermore, the commenter recommended that we consult with 
the Occupational Safety and Health Administration (OSHA), the National 
Institute for Occupational Safety and Health (NIOSH), and the Worker 
Education and Training Program

[[Page 63868]]

of the National Institute for Environmental Health Sciences (NIEHS) for 
more information on integrating worker health and safety protections 
into emergency planning.
    Response: While we believe that providers should prioritize the 
health and safety of their healthcare workers during an emergency, we 
do not believe that it is appropriate to include detailed requirements 
within this regulation. As we have previously stated, the regulation is 
not intended to be overly prescriptive. Therefore, providers have the 
discretion to establish policies and procedures in their emergency 
preparedness plans that meet the minimum requirements in this 
regulation and that are tailored to the specific needs and 
circumstances of the facility. We note that providers should continue 
to comply with pertinent federal, state, or local laws regarding the 
protection of healthcare workers in the workplace.
    While it is not within the scope of this rule to address OSHA, 
NIOSH, or NIEHS work place regulations, we encourage providers and 
suppliers to consider developing policies and procedures to protect 
healthcare workers during an emergency. We refer readers to the 
following list of resources to aid providers and suppliers in the 
formulation of such policies and procedures:

 https://www.osha.gov/SLTC/emergencypreparedness/
 http://www.cdc.gov/niosh/topics/emergency.html
 http://www.niehs.nih.gov/health/topics/population/occupational/index.cfm

    Comment: A few commenters noted that while section 1135 of the Act 
waives certain Conditions of Participation (CoPs) during a public 
health emergency, there is no authority to waive the Conditions for 
Payment (CfPs). The commenters recommended that the Secretary 
thoroughly review the requirements under the CoPs and the CfPs and seek 
authority from Congress to waive additional requirements under the CfPs 
that are burdensome and that affect timely access to care during 
emergencies.
    Response: While we appreciate the concerns of the commenters, these 
comments are outside the scope of this rule.
1. Integrated Health Systems
    In the proposed rule, we proposed that for each separately 
certified healthcare facility to have an emergency preparedness program 
that includes an emergency plan, based on a risk assessment that 
utilizes an all hazards approach, policies and procedures, a 
communication plan, and a training program.
    Comment: We received a few comments that suggested we allow 
integrated health systems to have one coordinated emergency 
preparedness program for the entire system.
    Commenters explained that an integrated health system could be 
comprised of two nearby hospitals, a LTC facility, a HHA, and a 
hospice. The commenters stated that under our proposed regulation, each 
entity would need to develop an individual emergency preparedness 
program in order to be in compliance. Commenters proposed that we allow 
for the development of one universal emergency preparedness program 
that encompasses one community-based risk assessment, separate 
facility-based risk assessments, integrated policies and procedures 
that meet the requirements for each facility, and coordinated 
communication plans, training and testing. They noted that allowing for 
a coordinated emergency preparedness program would ultimately reduce 
the burden placed on the individual facilities and provide for a more 
coordinated response during an emergency.
    Response: We appreciate the comments received on this issue. We 
agree that allowing integrated health systems to have a coordinated 
emergency preparedness program is in the best interest of the 
facilities and patients that comprise a health system. Therefore, we 
are revising the proposed requirements by adding a separate standard to 
the provisions applicable to each provider and supplier type. This 
separate standard will allow any separately certified healthcare 
facility that operates within a healthcare system to elect to be a part 
of the healthcare system's unified emergency preparedness program. If a 
healthcare system elects to have a unified emergency preparedness 
program, this integrated program must demonstrate that each separately 
certified facility within the system actively participated in the 
development of the program. In addition, each separately certified 
facility must be capable of demonstrating that they can effectively 
implement the emergency preparedness program and demonstrate compliance 
with its requirements at the facility level.
    As always, each facility will be surveyed individually and will 
need to demonstrate compliance. Therefore, the unified program will 
also need to be developed and maintained in a manner that takes into 
account the unique circumstances, patient populations, and services 
offered for each facility within the system. For example, for a unified 
plan covering both a hospital and a LTC facility, the emergency plan 
must account for the residents in the LTC facility as well as those 
patients within a hospital, while taking into consideration the 
difference in services that are provided at a LTC facility and a 
hospital. In addition, the healthcare system will need to take into 
account the resources each facility within the system has and any state 
laws that the facility must adhere to. The unified emergency 
preparedness program must also include a documented community-based 
risk assessment and an individual facility-based risk assessment for 
each separately certified facility within the health system, both 
utilizing an all-hazards approach. The unified program must also 
include integrated policies and procedures that meet the emergency 
preparedness requirements specific to each provider type as set forth 
in their individual set of regulations. Lastly, the unified program 
must have a coordinated communication plan and training and testing 
program. We believe that this approach will allow a healthcare system 
to spread the cost associated with training and offer a financial 
advantage to each of the facilities within a system. In addition, we 
believe that, in some cases this approach will provide flexibility and 
could potentially result in a more coordinated response during an 
emergency that will enable a more successful outcome.
2. Requests for Technical Assistance and Funding
    The December 2013 proposed rule included an appendix of the 
numerous resources and documents used to develop the proposed rule. 
Specifically, the appendix to the proposed rule included helpful 
reports, toolkits, and samples from multiple government agencies such 
as ASPR, the CDC, FEMA, HRSA, AHRQ, and the Institute of Medicine (See 
Appendix A, 78 FR 79198). In response to our proposed rule, we received 
numerous comments requesting that we provide facilities with increased 
funding and technical assistance to implement our proposed regulations.
    Comment: A few commenters appreciated the resources that we 
provided in the proposed rule, but expressed concerns that, despite the 
resources referenced in the regulation, busy and resource-constrained 
facilities will not have a simple and organized way to access technical 
assistance and

[[Page 63869]]

other valuable information in order to comply with the proposed 
requirements. Commenters indicated that despite the success of 
healthcare coalitions, they have not been established in every region.
    Commenters suggested that formal technical assistance should be 
available to facilities to help them successfully implement their 
emergency preparedness requirements. A commenter recommended that ASPR 
should lead this effort given its expertise in emergency preparedness 
planning and its charge to lead the nation in preventing, preparing 
for, and responding to the adverse health effects of public health 
emergencies. Another commenter suggested that we consider hosting 
regional meetings for facilities to share information and resources and 
that we provide region specific resources on our Web site. Commenters 
encouraged CMS to promote collaborative planning among facilities and 
provide the support needed for facilities to leverage each other's 
resources. These commenters believe that networks of facilities will be 
in a better position than governmental resources to identify cost and 
time saving efficiencies, but need support from CMS to coordinate their 
efforts.
    Response: We appreciate the feedback from commenters and understand 
how valuable guidance and resources will be to providers and suppliers 
in order to comply with this regulation. We do not anticipate providing 
formal technical assistance, such as CMS-led trainings, to providers 
and suppliers. Instead, as with all of our regulations, we will release 
interpretive guidance for this regulation that will aid facilities in 
implementing these regulations and provide information regarding best 
practices. We strongly encourage facilities to review the 
interpretative guidance from us, use the guidance to identify best 
practices, and then network with other facilities to develop strategic 
plans. Providers and suppliers impacted by this regulation should 
collaborate and leverage resources in developing emergency preparedness 
programs to identify cost and time saving efficiencies. We note that in 
this final rule we have revised the proposed requirements to allow 
integrated health systems to elect to have one unified emergency 
preparedness program (see Section II.A.1.Intergrated Health Systems for 
a detailed discussion of the requirement). We believe that 
collaborative planning will not only leverage the financial burden on 
facilities, but also result in a more coordinated response to an 
emergency event.
    In addition, we note that in the proposed rule, we indicated 
numerous resources related to emergency preparedness, including helpful 
reports, toolkits, and samples from ASPR, the CDC, FEMA, HRSA, AHRQ, 
and the Institute of Medicine (See Appendix A, 78 FR 79198). Providers 
and suppliers should use these many resources as templates and the 
framework for getting their emergency preparedness programs started. We 
also refer readers to SAMHSA's Disaster Technical Assistance Center 
(DTAC) for more information on delivering an effective mental health 
and substance abuse (behavioral health) response to disasters at http://www.samhsa.gov/dtac/.
    Finally we note that ASPR, as a leader in healthcare system 
preparedness, developed and launched the Technical Resources, 
Assistance Center, and Information Exchange (TRACIE). TRACIE is 
designed to provide resources and technical assistance to healthcare 
system preparedness stakeholders in building a resilient healthcare 
system. There are numerous products and resources located within the 
TRACIE Web site that target specific provider types affected by this 
rule. While TRACIE does not focus specifically on the requirements 
implemented in this regulation, this is a valuable resource to aid a 
wide spectrum of partners with their health system emergency 
preparedness activities. We strongly encourage providers and suppliers 
to utilize TRACIE and leverage the information provided by ASPR.
    Comment: Some commenters noted that their region is currently 
experiencing a reduction in the federal funding they receive through 
the HPP. These commenters stated that the HPP program has proven to be 
successful and encouraged healthcare entities impacted by this 
regulation to engage their state HPP for technical assistance and 
training while developing their emergency preparedness programs. 
Commenters shared that HPP staff have established trusting and 
fundamental relationships with facilities, associations, and emergency 
managers throughout their state. Commenters expressed that while the 
program has been instrumental in supporting their state's healthcare 
emergency response, it does not make sense to impose these new 
emergency preparedness regulations while financial resources through 
the HPP are diminishing. Commenters stressed that the HPP program alone 
cannot support the rollout of these new regulations and emphasized that 
a strong and well-funded HHP program is needed to contribute to the 
successful implementation of these new requirements. Commenters also 
suggested that CMS offer training to the states' HPP programs, so that 
these agencies can remain in a central leadership role within their 
states.
    Response: We appreciate the feedback and agree that the HPP program 
has been a fundamental resource for developing healthcare emergency 
preparedness programs. While we recognize that HPP funding is limited, 
we want to emphasize that the HPP program is not intended to solely 
fund a facility's individual emergency preparedness program and 
activities. Despite the limited financial resources, healthcare 
facilities should continue to engage their healthcare coalitions and 
state HPP coordinators for training and guidance. We encourage 
healthcare facilities, particularly those in neighboring geographic 
areas, to collaborate and build relationships that will allow 
facilities to share and leverage resources.
    Comment: A few commenters noted that, while these new emergency 
preparedness regulations should be put in place to protect vulnerable 
communities, there should also be incentives to help facilities meet 
these new standards. Many commenters expressed concerns about the 
decrease in funding available to state and local governments. Most 
commenters recommended that grant funding and loan programs be provided 
to support hiring staff to develop or modify emergency plans. However, 
a few commenters suggested that federal funding should be allocated to 
the nation's most vulnerable counties. These commenters believe that 
special federal funding consideration should not be provided to all, 
but rather should be given to those counties and cities with a uniquely 
dense population. A commenter believed that incentives should be put in 
place to reward those facilities that are found compliant with the new 
standards. In addition, several commenters requested that CMS provide 
additional Medicare payment to providers and suppliers for implementing 
these emergency preparedness requirements.
    Response: We currently expect facilities to have and develop 
policies and procedures for patient care and the overall operations. 
The emergency preparedness requirement may increase costs in the short 
term because resources will have to be devoted to the assessment and 
development of an emergency plan utilizing an all-hazards approach. 
While the requirements could result in some immediate costs to a

[[Page 63870]]

provider or supplier, we believe that developing an emergency 
preparedness program will overall be beneficial to any provider or 
supplier. In addition, planning for the protection and care of 
patients, clients, residents, and staff during an emergency or a 
disaster is a good business practice. As we have previously noted, CMS 
has the authority to create and modify health and safety CoPs, which 
establish the requirements that a provider must meet in order to 
participate in the Medicare or Medicaid programs.
3. Requirement To Track Patients and Staff
    In the proposed rule, we requested comments on the feasibility of 
tracking staff and patients in outpatient facilities.
    Comment: Overall commenters agreed that there is not a crucial need 
for outpatient facilities to track their patients as compared to 
inpatient facilities. Commenters noted that outpatient providers and 
suppliers would most likely close their facilities prior to or 
immediately after an emergency, sending staff and patients home. We did 
not propose the tracking requirement for transplant centers, CORFs, 
Clinics, Rehabilitation Agencies, and Public Health Agencies as 
Providers of Outpatient Physical Therapy and Speech-Language Pathology 
Services, and RHCs/FQHCs. For OPOs we proposed that they would only 
need to track staff. We stated that transplant centers' patients and 
OPOs' potential donors would be in hospitals, and thus, would be the 
hospital's responsibility.
    Response: We agree with the majority of commenters and continue to 
believe that it is impractical for outpatient providers and suppliers 
to track patients and staff during and after an emergency. In the event 
of an emergency outpatient providers and suppliers will have the 
flexibility to cancel appointments and close their facilities. 
Therefore, we are finalizing the rule as proposed. Specifically, we do 
not require transplant centers, RHCs/FQHCs, CORFs, Clinics, 
Rehabilitation Agencies, and Public Health Agencies as providers of 
Outpatient Physical Therapy and Speech-Language Pathology Services to 
track their patients and staffs. We are also finalizing our proposal 
for OPOs to track staff only both during and after an emergency. A 
detailed discussion of comments specific to OPOs tracking staff can be 
found in section II.Q. of this final rule (Emergency Preparedness 
Regulations for Organ Procurement Organizations).
    Comment: In addition to the feedback we received on whether we 
should require outpatient providers and suppliers to track their 
patients and staff, we also received varying comments in regards to the 
providers and suppliers that we did propose to meet the tracking 
requirement.Commenters supported the proposal for certain providers and 
suppliers to track staff and patients, and agreed that a system is 
needed. Some understood that the information about staff and patient 
location would be needed during an emergency, but stated that it would 
be burdensome and often unrealistic to expect providers and suppliers 
to locate individuals after an emergency event. Some commenters noted 
that patients at a receiving facility would be the responsibility of 
the receiving facility. Some commenters stated that tracking of 
patients going home is not their responsibility, or would be difficult 
to achieve. A commenter believed that tracking of staff would be a 
violation of staff's privacy. A commenter stated that in their large 
facility, only the ``staff on duty'' at the time of the emergency would 
be in their staffing system. Some commenters stated that staff would be 
difficult to track because some facilities have hundreds or thousands 
of employees, and some staff may have left to be with their families. 
Some commenters suggested that CMS promote the use of voluntary 
registries to help track their outpatient populations and encouraged 
coordination of these registries among facility types. A few commenters 
stated that one of the tools discussed in the preamble for tracking 
patients; namely, The Joint Patient Assessment and Tracking System 
(JPATS) was only available for hospitals and did not include other 
providers such as LTC facilities, and several stated the system is 
incompatible with their IT systems.
    Response: For RNHCIs, PRTFs, PACE organizations, LTC facilities, 
ICFs/IID, hospitals, and CAHs, we proposed that these providers 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. Despite providing services on an outpatient basis, we also 
proposed to require hospices, HHAs, and ESRD facilities to assume this 
responsibility because these providers and suppliers would be required 
to provide continuing patient care during an emergency. We also 
proposed the tracking requirement for ASCs because we believed an ASC 
would maintain responsibility for their staff and patients if patients 
were in the facility.
    After carefully analyzing the issues raised by commenters regarding 
the process to track staff and patients during and after an emergency, 
we agree with the commenters that our proposed requirements could be 
unnecessarily burdensome. We are revising the tracking requirements 
based on the type of facility. For CAHs, Hospitals, and RNHCIs we are 
removing the proposed requirement for tracking after an emergency. 
Instead, in this final rule we require that these facilities must 
document the specific name and location of the receiving facility or 
other location for patients who leave the facility during the 
emergency. We would expect facilities to track their on-duty staff and 
sheltered patients during an emergency and indicate where a patient is 
relocated to during an emergency (that is, to another facility, home, 
or alternate means of shelter, etc.).
    Also, since providers and suppliers are required to conduct a risk 
assessment and develop strategies for addressing emergency events 
identified by the risk assessment, we would expect the facility to 
include in its emergency plan a method for contacting off-duty staff 
during an emergency and procedures to address other contingencies in 
the event staff are not able to report to duty which may include but 
are not limited to staff from other facilities and state or federally-
designated health professionals.
    For PRTFs, LTC facilities, ICF/IIDs, PACE organizations, CMHCs, and 
ESRD facilities we are finalizing as proposed the requirement to track 
staff and patients both during and after an emergency. We have 
clarified that the requirement applies to tracking on-duty staff and 
sheltered patients. Furthermore, we clarify that if on-duty staff and 
sheltered patients are relocated during the emergency, the provider or 
supplier must document the specific name and location of the receiving 
facility or other location. Unlike inpatient facilities, PRTFs, ICF/
IIDs, and LTC facilities are residential facilities and serve as the 
patient's home, which is why in these settings we refer to the patients 
as ``residents.'' Similar to these residential facilities ESRD 
facilities, CMHCs, and PACE organizations, provide a continuum of care 
for their patients. Residents and patients of these facilities would 
anticipate returning to these facilities after an emergency. For this 
reason, we believe that it is imperative for these facilities to know 
where their residents/patients and staff are located during and after 
the

[[Page 63871]]

emergency to allow for repatriation and the continuation of regularly 
scheduled appointments.
    While we pointed out JPATS as a tool for providers and suppliers, 
we note that we indicated that we were not proposing a specific type of 
tracking system that providers and suppliers must use. We also 
indicated that in the proposed rule that a number of states have 
tracking systems in place or under development and the systems are 
available for use by healthcare providers and suppliers. We encourage 
providers and suppliers to leverage the support and resources available 
to them through local and national healthcare systems, healthcare 
coalitions, and healthcare organizations for resources and tools for 
tracking patients.
    We have also reviewed our proposal to require ASCs, hospices, and 
HHAs to track their staff and patients before and after an emergency. 
We discuss in detail the comments we received specific to these 
providers and suppliers and revisions to their proposed tracking 
requirement in their specific section later in this final rule.

B. Implementation Date

    We proposed several variations on an implementation date for the 
emergency preparedness requirements (78 FR 79179). Regarding the 
implementation date, we requested information on the following issues:
     A targeted approach to emergency preparedness that would 
apply the rule to one provider or supplier type or a subset of provider 
types, to learn from implementation prior to requiring compliance for 
all 17 types of providers and suppliers.
     A phased-in approach that would implement the requirements 
over a longer time horizon, or differential time horizons for the 
different provider and supplier types.
    Comment: Most commenters recommended that CMS set a later 
implementation date for the emergency preparedness requirements. Some 
commenters recommended that we use a targeted approach, whereby the 
rule would be implemented first by one provider/supplier type or a 
subset of provider/supplier types, with later implementation by other 
provider/supplier types, so they can learn from prior implementation at 
other facilities. Others recommended that CMS phase in the requirements 
over a longer time horizon.
    Many commenters recommended that CMS require implementation at 
hospitals or LTC facilities first, so that other facilities could 
benefit from the experience and lessons learned by these providers. 
Some of these commenters stated that these providers have the most 
capacity to implement these requirements. A commenter recommended that 
hospitals implement the requirements of the rule first, followed by 
CAHs and other inpatient provider types and LTC facilities. Other 
provider and supplier types would follow thereafter. The commenter 
recommended that CMS establish a period of non-enforcement for each 
implementation phase, while a Phase 1 evaluation is conducted and 
feedback is given to other facilities.
    Several commenters, including major hospital associations, 
disagreed with CMS' proposal to implement all of the requirements 1 
year after the final rule is published. The commenters noted that 
implementation of all the requirements after 1 year would be burdensome 
and costly to many facilities. In addition, a few commenters noted that 
certain facilities, mainly rural and small facilities, may be at a 
disadvantage because they have not participated in national emergency 
preparedness planning efforts or because they lack the necessary 
resources to implement emergency preparedness plans.
    A few commenters drew a distinction between accredited and non-
accredited facilities and recommended that hospitals implement the 
requirements within a year or 2 after publication of the final rule. 
Some of the commenters noted that non-accredited facilities, CAHs, 
HHAs, and hospices, would need more time. Several of these commenters 
also stated that hospitals that need more time for implementation 
should be able to propose to CMS a reasonable period of time to comply. 
A few commenters stated that the emergency preparedness proposal is 
unlike the standards utilized by the TJC and that enforcement of these 
requirements should be at a later date for both accredited and non-
accredited facilities.
    Some commenters recommended that CMS give ASCs and FQHCs additional 
time to come into compliance. A commenter recommended that CMS set a 
later implementation date for the requirements and provide a flexible 
implementation timeframe based on provider type and resources. A few 
commenters stated that the implementation timeline is too short for 
rehabilitation facilities, long-term acute care facilities, LTC 
facilities, behavioral health inpatient facilities, and ICF/IIDs.
    A few commenters recommended that CMS phase-in implementation on a 
standard-by-standard basis. A commenter recommended that LTC facilities 
implement the requirements 12 to 18 months after hospitals. 
Furthermore, the commenter recommended an 18 to 24 month phase-in of 
emergency systems and a 24 to 38 month phase-in for the training and 
testing requirements. Another commenter recommended that facilities be 
allowed to comply with the initial planning requirements within 2 
years, and then be allowed to comply with the subsistence and 
infrastructure requirements in years 3 and 4.
    The commenters varied in their recommendations on the timeframe CMS 
should use for the implementation date. These recommendations ranged 
from 6 months to 5 years, with a few commenters recommending even 
longer periods. Some commenters noted that applying a targeted 
approach, covering one or a subset of provider classes to learn from 
implementation prior to extending the rule to all groups, would also 
allow a longer period of time for other provider/supplier types to 
prepare for implementation. Furthermore, a commenter noted that a 
phased in approach would help to alleviate the cost burden on 
facilities that would need to create an emergency plan and train and 
test staff.
    Response: We appreciate the commenters' feedback. We considered a 
phased-in approach in a number of ways. We looked at phasing in the 
implementation of various providers and suppliers; and phasing in the 
various standards of the regulation. We concluded that this approach 
would be too difficult to implement, enforce, and evaluate. Also, this 
would not allow communities to have a comprehensive approach to 
emergency preparedness. However, we agree that there should be a later 
implementation date for the emergency preparedness requirements. 
However, we do not believe that a targeted or phased-in approach to 
implementation is appropriate. One thing we proposed and are now 
finalizing to address this concern is extending the implementation 
timeframe for the requirements to 1 year after the effective date of 
this final rule (see section section II, Provisions of the Proposed 
Rule and Responses to Public Comments, part B, Implementation Date). We 
believe it is imperative that each provider thinks in terms broader 
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. To encourage providers to develop a 
comprehensive and coordinated approach to emergency preparedness, all 
providers need to adopt the requirements in this final rule at the same 
time.

[[Page 63872]]

    Commenters have stated that hospitals that are TJC-accredited are 
part of the Hospital Preparedness Program (HPP) program, and those 
hospitals that follow National Fire Protection Association 
(NFPA[supreg]) standards, have already established most of the 
emergency preparedness requirements set out in this rule. Based on 
CDC's National Health Statistics Reports; Number 37, March 24, 2011, 
page 2 (NCHS-2008PanFluandEP_NHAMCSSurveyReport_2011.pdf), about 67.9 
percent of hospitals had plans for all six hazards (epidemic-pandemic, 
biological, chemical, nuclear-radiological, explosive-incendiary, and 
natural incidents). Nearly all hospitals (99.0 percent) had emergency 
response plans that specifically addressed chemical accidents or 
attacks, which were not significantly different from the prevalence of 
plans for natural disasters (97.8 percent), epidemics or pandemics 
(94.1 percent), and biological accidents or attacks. However, we also 
believe that other facilities will be ready to begin implementation of 
these rules at the same time as hospitals. We believe that most 
facilities already have some basic emergency preparedness requirements 
that can be built upon to meet the requirements set out in this final 
rule. We note that we have modified or eliminated some of our proposed 
requirements for certain providers and suppliers, as discussed later in 
this final rule, which should ease concerns about implementation. 
Therefore, we believe that all affected providers and suppliers will be 
able to comply with these requirements 1 year after the final rule is 
published.
    We do not believe a period of non-enforcement is appropriate as it 
will further prolong the implementation of necessary and life-saving 
emergency preparedness planning requirements by facilities. A later 
implementation date will leave the most vulnerable patient populations 
and unprepared facilities without a valuable, life-saving emergency 
preparedness plan should an emergency arise. We have not received 
comments that persuaded us that a later implementation date for these 
requirements of more than 1 year is beneficial or appropriate for 
providers and suppliers or their patients.
    In response to commenters that opposed our proposal to implement 
the requirements 1 year after the final rule was published and 
recommended that we afford facilities more time to implement the 
requirements, we do not believe that the requirements will be overly 
burdensome or overly costly to providers and suppliers. We note, as we 
have heard from many commenters, that many facilities already have 
established emergency preparedness plans, as required by accrediting 
organizations. However, we acknowledge that there may be a significant 
amount of work that small facilities and those with limited resources 
will need to undertake to establish an emergency preparedness plan that 
conforms to the requirements set out in this regulation. However, we 
believe that prolonging the requirements in this final rule by 1 year 
will provide sufficient time for implementation among the various 
facilities to meet the emergency preparedness requirements. We 
encourage facilities to engage and collaborate with their local 
partners and healthcare coalitions in their area for assistance. 
Facilities may also access ASPR's TRACIE web portal, which is a 
healthcare emergency preparedness information gateway that helps 
stakeholders at the federal, state, local, tribal, non-profit, and for-
profit levels have access to information and resources to improve 
preparedness, response, recovery, and mitigation efforts. ASPR TRACIE, 
located at: https://asprtracie.hhs.gov/, is an excellent resource for 
the various CMS providers and suppliers as they seek to implement the 
enhanced emergency preparedness requirements. We encourage facilities 
to engage and collaborate with their local partners and healthcare 
coalitions in their area for technical assistance as they include local 
experts and can provide regional information that can inform the 
requirements as set forth.
    Comment: Some commenters recommended that CMS implement all of the 
emergency preparedness requirements 1 year after the final rule is 
published. Other commenters recommended that CMS implement the 
requirements as soon as the final rule is published or set an 
implementation date that is less than 1 year from the effective date of 
this final rule. A few of these commenters, including a major 
beneficiary advocacy group, stated that implementation should begin as 
soon as practicable, or immediately after the final rule is published 
and cautioned against a later implementation date that may leave 
facilities without important emergency preparedness plans during an 
emergency.
    Some of these commenters stated that hospitals in particular 
already have emergency preparedness plans in place and are well 
equipped and prepared to implement the requirements set out in these 
regulations over the course of a year. Some commenters noted that most 
hospitals are fully aware of the 4 emergency preparedness requirements 
set out in the proposed rule through current accreditation standards. 
Furthermore, the commenters noted that these four requirements would 
not impose any additional burdens on hospitals. A few commenters 
acknowledged that some hospitals are not under the purview of an 
accrediting agency and therefore may need up to 1 year to implement the 
requirements.
    Response: We appreciate the commenters' feedback. We agree with the 
commenters' view that implementation of the requirements should occur 1 
year after the final rule is published for all 17 types of providers 
and suppliers. We believe that an implementation date for these 
requirements that is 1 year after the effective date of this final rule 
will allow all facilities to develop an emergency preparedness plan 
that meets all of the requirements set out within these regulations. 
While we understand why some commenters would want these requirements 
to be implemented shortly after publication of the final rule, we also 
understand some commenters' concerns about that timeframe. We believe 
that facilities will need a period of time after the final rule is 
published to plan, develop, and implement the emergency preparedness 
requirements in the final rule. Accordingly, we believe that 1 year is 
a sufficient amount of time for facilities to meet these requirements.
    Comment: A few commenters recommended that CMS include a provision 
that would allow facilities to apply for additional time extensions or 
waivers for implementation. A commenter recommended that CMS allow 
facilities to rely on their existing policies if the facility can 
demonstrate that the existing policies align with the emergency 
preparedness plan requirements and achieve a similar outcome.
    Response: We do not agree with including a provision that will 
allow for facilities to apply for extensions or waivers to the 
emergency preparedness requirements. We believe that an implementation 
date that is beyond 1 year after the effective date of this final rule 
for these requirements is inappropriate and leaves the most vulnerable 
facilities and patient populations without life-saving emergency 
preparedness plans.
    However, we do understand that some facilities, especially smaller 
and more rural facilities, may experience difficulties developing their 
emergency preparedness plans. Therefore, we believe that setting an 
implementation date of 1 year after the effective date of this final 
rule for these requirements will give these and other facilities

[[Page 63873]]

sufficient time for compliance. As stated earlier, we encourage 
facilities to form coalitions in their area for assistance in meeting 
these requirements. We also encourage facilities to utilize the many 
resources we have included in the proposed and final rule.
    We appreciate that some facilities have existing emergency 
preparedness plans. However, all facilities will be required to develop 
and maintain an emergency preparedness plan based on an all-hazards 
approach and address the four major elements of emergency preparedness 
in their plan that we have identified in this final rule. Each facility 
will be required to evaluate its current emergency preparedness plan 
and activities to ensure that it complies with the new requirements.
    Comment: A few commenters recommended that CMS implement 
enforcement of the final rule when the interpretive guidance (IG) is 
finalized by CMS. A few commenters noted that this implementation data 
should include a period of engagement with hospitals and other 
providers and suppliers, a period to allow for the development and 
testing of surveyor tools, and a readiness review of state survey 
agencies that is complete and publicly available. A commenter 
recommended that facilities implement the requirements 5 years after 
the IGs have been published. Another commenter recommended that CMS 
phase-in implementation in terms of enforcement and roll out, allowing 
time for full implementation and assistance to facilities and state 
surveyors.
    A few commenters recommended that providers be allowed a period of 
time where they are held harmless during a transitional planning 
period, where providers may be allotted more time to plan and implement 
the emergency preparedness requirements.
    Response: We disagree with the commenter's recommendations that we 
should implement this regulation after the IGs have been published. 
Additionally, we disagree with the recommendation that CMS phase in 
enforcement or hold facilities harmless for a period of time while the 
requirements are being implemented, and we do not believe that it is 
appropriate to implement the CoPs after the IGs are established. The 
IGs are subregulatory guidelines which establish our expectations for 
the function states perform in enforcing the regulatory requirements. 
Facilities do not require the IGs in order to implement the regulatory 
requirements. We note that CMS historically releases IGs for new 
regulations after the final rule has been published. This EP rule is 
accompanied by extensive resources that providers and suppliers can use 
to establish their emergency preparedness programs. In addition, CMS 
will create a designated Web site for the Emergency Preparedness Rule 
at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/index.html that will house information for 
providers, suppliers and surveyors. The Web site will contain the link 
to the final rule and will also include templates, provider checklists, 
sample emergency preparedness plans, disaster specific information and 
lessons learned. CMS will also be releasing an all-hazards FAQ document 
that will be posted to Web site as well. We will also continue to 
communicate with providers and other stakeholders about these 
requirements through normal channels. For example we will communicate 
with surveyors via Survey and Certification memoranda and provide 
information to facilities via, provider forums, press releases and 
Medicare Learning Network publications. We continue to believe that 
setting a later implementation date for the enforcement of these 
requirements will leave the most vulnerable patient populations and 
unprepared facilities without valuable, life-saving emergency 
preparedness plans should an emergency arise. One year is a sufficient 
amount of time for facilities to meet these requirements.
    Comment: Several commenters, including national and local 
organizations, and providers, supported using a transparent process in 
the development of interpretive guidelines for state surveyors. They 
suggested consulting with industry experts, healthcare organizations, 
accrediting bodies and state survey agencies in the development of 
clear and concise interpretation and application of the IGs nationwide. 
One provider suggested that CMS post the draft guidance electronically 
for a period of time and provide an email address for stakeholders to 
offer comments. Furthermore, this provider suggested that the guidance 
be pilot-tested and revised prior to adoption.
    Response: We thank the commenters for their suggestions. In 
addition to the CoPs/CfCs, IGs will be developed by CMS for each 
provider and supplier types. We also note that surveyors will be 
provided training on the emergency preparedness requirements so that 
enforcement of the rule will be based on the regulations set forth 
here. While comments on the process for developing the interpretive 
guidelines is outside the scope of this proposed rule, we agree that 
consistency and conciseness in the IGs is critical in the evaluation 
process for providers and suppliers in meeting these emergency 
preparedness requirements.
    Comment: A few commenters recommended that CMS allow multiple 
facility types that are administered by the same owner to obtain 
waivers of specific requirements or have a single multi-facility plan 
approved, if they can collectively adopt a functionally equivalent 
strategy based on the requirements that may apply to one of their 
facility types. The commenters note that operation of more than one 
facility type is not uncommon among Tribal health programs.
    Response: Although we disagree with the commenter's recommendation 
that we allow multiple facility types that are administered by the same 
owner to obtain implementation waivers of specific requirements, we 
agree that multiple facilities that are administered by the same owner, 
that effectively operate as an integrated health system, can have a 
unified emergency preparedness program. We previously discussed this 
final policy in the Integrated Health System section of this final 
rule.
    Comment: A commenter recommended that the states take the lead on 
determining the timing of implementation for various providers and 
suppliers.
    Response: We do not believe that State governments or State 
agencies should determine the timing of implementation for facilities' 
emergency preparedness plans. While the State government will provide 
valuable resources during a disaster, CMS is responsible for the 
implementation of the federal regulations for Medicare and Medicaid 
certified providers and suppliers. Furthermore, it will be difficult 
for survey agencies to monitor the requirements in this rule if each 
State has different implementation timelines. As stated previously, we 
believe that most providers have basic emergency preparedness plans and 
protocols and that they are capable of implementing the requirements 
within 1 year after the final rule is published.
    After consideration of the comments received, we are finalizing our 
proposal, without modification, to require implementation of all of the 
requirements for all providers and suppliers 1 year after the final 
rule is published.

C. Emergency Preparedness Regulations for Hospitals (Sec.  482.15)

    Our proposed hospital regulatory scheme was the basis for all other

[[Page 63874]]

proposed emergency preparedness requirements as set out in the proposed 
rule. Since application of the proposed regulatory language for 
hospitals would be inappropriate or overly burdensome for some 
facilities, we tailored specific proposed requirements to each 
providers' and suppliers' unique situation. In the December 2013 
proposed rule we provided a detailed discussion of each proposed 
hospital requirement, as well as resources that facilities could use to 
meet the proposed requirements, a methodology to establish and maintain 
emergency preparedness, and links to guidance materials and toolkits 
that could be used to help meet the requirements. We encourage readers 
to refer to the proposed rule for this detailed discussion.
    As previously discussed, many commenters commented on the proposed 
regulations for hospitals, but indicated that their comments could also 
be applied to the additional provider and supplier types. Therefore, 
where appropriate, we collectively refer to hospitals and the other 
providers and suppliers as ``facilities'' in this section of the final 
rule.
1. Risk Assessment and Emergency Plan (Sec.  482.15(a))
    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. Sec.  
440.10(a)(3)(iii) and 440.140 require hospitals, including psychiatric 
hospitals, to meet the Medicare CoPs to qualify for participation in 
Medicaid. The hospital and psychiatric hospital CoPs are found at 
Sec. Sec.  482.1 through 482.62.
    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 often the focal points for healthcare 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 proposed a new requirement under Sec.  482.15 that would require 
hospitals to have both an emergency preparedness program and an 
emergency preparedness plan. To ensure that all hospitals operate as 
part of a coordinated emergency preparedness system, we proposed at 
Sec.  482.15 that all hospitals establish and maintain an emergency 
preparedness plan that complies with both federal and state 
requirements. Additionally, we proposed that the emergency preparedness 
plan be reviewed and updated at least annually. As part of an annual 
review and update, staff are required to be trained and be familiar 
with many policies and procedures in the operation of their facility 
and are held responsible for knowing these requirements. Annual reviews 
help to refresh these policies and procedures which would include any 
revisions to them based on the facility experiencing an emergency or as 
a result of a community or natural disaster.
    In keeping with the focus of the emergency management field, we 
proposed that prior to establishing an emergency preparedness plan, the 
hospital and all other providers and suppliers would first perform a 
risk assessment based on using an ``all-hazards'' approach. 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 those hospitals and all other 
providers and suppliers will have the capacity to address a broad range 
of related emergencies.
    We stated that it is imperative that hospitals perform all-hazards 
risk assessment consistent with the concepts outlined in the National 
Preparedness System, published by the United States (U.S.) Department 
of Homeland Security, as well as guidance provided by Agency for 
Healthcare Research and Quality (AHRQ), to help hospital planners and 
administrators make important decisions about how to protect patients 
and healthcare 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. We also 
provided additional guidance and resources for assistance with 
designing and performing a hazard vulnerability assessment.
    In the proposed rule (78 FR 79094), we stated that in order to meet 
the proposed requirement for a risk assessment at Sec.  482.15(a)(1), 
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 what 
arrangements with other hospitals, other healthcare providers or 
suppliers, or other entities might be needed to ensure that essential 
services could be provided during an emergency.
    We proposed 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 care 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.
    At Sec.  482.15(a)(3), we proposed that a hospital's emergency plan 
address its patient population, including, but not limited to, persons 
at-risk. We also discussed in the preamble of the proposed rule that 
``at-risk populations'' are 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

[[Page 63875]]

pharmacological dependency. According to the section 2802 of the PHS 
Act (42 U.S.C. 300hh-1) as added by Pandemic and All-Hazards 
Preparedness Act (PAHPA) in 2006, in ``at-risk individuals'' means 
children, pregnant women, senior citizens and other individuals who 
have special needs in the event of a public health emergency as 
determined by the Secretary. In 2013, the Pandemic and All-Hazards 
Preparedness Reauthorization Act (PAHPRA) amended the PHS Act (http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf) and added 
that consideration of the public health and medical needs of ``at-risk 
individuals'' includes taking into account the unique needs and 
considerations of individuals with disabilities. The National Response 
Framework (NRF), the primary federal document guiding how the country 
responds to all types of disasters and emergencies, includes in its 
description of ``at-risk individuals'' children, individuals with 
disabilities and others with access and functional needs; those from 
religious, racial and ethnically diverse backgrounds; and people with 
limited English proficiency. We have included additional examples of 
at-risk populations, including definitions from both PHS Act and NRF 
and have expanded the definition to include examples used in the 
healthcare industry. We have stated that the patient population may not 
be limited to just persons at-risk but may include, for example, 
descriptions of patient populations unique to their geographical areas, 
such as CMHCs and PRTFs. The definition of at-risk populations provided 
in the regulation text is to include all of the populations discussed 
in the NRF and PHS Act definitions and are defined within the 
individual providers and suppliers included in this regulation.
    We also proposed 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. In regard to emergency preparedness planning, 
we also proposed 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 proposed 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 stated that we believed planning 
with officials in advance of an emergency to determine how such 
collaborative and cooperative efforts would achieve and foster a 
smoother, more effective, and more efficient response in the event of a 
disaster. Providers and suppliers must document efforts made by the 
facility to cooperate and collaborate with emergency preparedness 
officials.
    Comment: A few commenters stated that the term ``all-hazards'' is 
too broad and instead should be geared towards possible emergencies in 
their geographical area. The commenters stated that the term ``all-
hazards'' should be replaced with ``Hazard Vulnerability Assessment'' 
(HVA) to be more in line with the current emergency preparedness 
industry language that providers and suppliers are more familiar. 
Commenters suggested that CMS align the final rule with the current 
requirements of accreditation organizations. Some commenters requested 
clarification as to what an HVA is and how it is performed. 
Furthermore, commenters encouraged us to discuss the risks or 
emergencies that a hospital may expect to confront. They recommended 
adding language to require that the hospital's emergency plan be based 
on an HVA utilizing an all-hazards approach that identifies the 
emergencies that the hospital may reasonably expect to confront.
    Response: In ``An All Hazards Approach to Vulnerable Populations 
Planning'' by Charles K.T. Ishikawa, MSPH, Garrett W. Simonsen, MSPS, 
Barbara Ceconi, MSW, and Kurt Kuss, MSW (see https://apha.confex.com/apha/135am/webprogram/Paper160527.html), 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. In the 
proposed rule, we referred to a ``hazard vulnerability risk 
assessment'' as a ``risk assessment'' that is performed using an all-
hazards approach. However, we understand that some providers use the 
term ``hazard vulnerability assessment ``(HVA) while other providers 
and federal agencies use terms such as ``all-hazards self-assessment'' 
or ``all-hazards risk assessment'' to describe the process by which a 
provider will assess and identify potential gaps in its emergency 
plan(s). The providers and suppliers discussed in this regulation 
should utilize an all-hazards approach to perform a ``hazard 
vulnerability risk assessment.'' While those providers and suppliers 
that are more advanced in emergency preparedness will be familiar with 
some of the industry language, we believe that some providers/suppliers 
might not have a working knowledge of the various terms; therefore, we 
used language defining risk assessment activities that would be easily 
understood by all providers and suppliers that are affected by this 
regulation and align with the national preparedness system and 
terminology.
    Comment: We received many comments on our proposed changes to 
require hospitals to develop an emergency plan utilizing an all-hazards 
approach based on a facility- and community-based risk assessment from 
individuals, national and state professional organizations, 
accreditation organizations, individual and multi-hospital systems, and 
national and state hospital organizations.
    Some commenters recommended adding ``local'' after applicable 
federal and state emergency preparedness requirements since some states 
already have local laws and regulations governing their emergency 
management activities. There was concern voiced that several of CMS' 
proposals may conflict or overlap with state and local laws and 
requirements. They recommended that CMS should defer to state and local 
standards where the proposed CoPs and CfCs would overlap with, be less 
stringent than, or conflict with those standards.
    Response: While we agree that the responsibility for ensuring a 
community-wide coordinated disaster preparedness response is under the 
state and local emergency authorities, healthcare facilities will still 
be required to perform a risk assessment, develop an emergency plan, 
policies and procedures, communication plan, and train and test all 
staff to comply with the requirements in this final rule. We disagree 
that we should defer to state and local standards for emergency 
preparedness. Also, we do not believe that these requirements will 
conflict with any state and local standards. These emergency 
preparedness

[[Page 63876]]

requirements are the minimal requirements that facilities must meet in 
order to be in compliance with the emergency preparedness CoPs/CfCs. 
However, facilities have the option of including as part of their 
requirements, additional state, local and facility based standards. In 
particular, the new requirements will require a coordinated and 
collaborative relationship with state and local governments during a 
disaster. As such, we agree with the commenters that it is appropriate 
to add the word ``local'' in the introductory paragraph for the 
emergency preparedness requirements. For consistency within the 
regulation, we will also add the term ``local'' to the communication 
plan requirements throughout the regulation.
    Comment: Some commenters expressed concern that the term 
``emergency preparedness program'' was discussed in the preamble and 
then the regulation text used the term ``Emergency preparedness plan,'' 
and they thought the use of both terms was confusing, a duplication of 
efforts and a strain on limited resources. Some thought the plan 
included policies and procedures and training and did not refer to the 
term ``program.'' Some commenters questioned whether the proposed rule 
required hospitals to have both an emergency preparedness program and 
an emergency preparedness plan and questioned if documentation was 
required for both. They recommended that CMS should clearly stipulate 
in its standards that only one document is required to demonstrate 
compliance with the standards.
    Some commenters believed that the emergency preparedness policies 
and procedures based on the emergency plan and risk assessment could be 
a potential duplication of effort. They recommended that CMS only 
require healthcare organizations to document how they will meet the 
emergency preparedness standards in the emergency preparedness plan, 
and not require separate policies and procedures. They stated that the 
concept of an emergency preparedness plan is equivalent to a policy, 
and the emergency preparedness plan states how the hospital will meet a 
standard.
    Response: We agree that the words ``program'' and ``plan'' are 
often used interchangeably. However, in this final rule we use the word 
``program'' to describe a facility's comprehensive approach to meeting 
the health and safety needs of their patient population during an 
emergency. We use the word ``plan'' to describe the individual 
components of the program such as an emergency plan, policies and 
procedures, a communication plan, testing and training plans. 
Regardless of the various synonyms for the words ``program'' or 
``plan'', we expect a facility to have a comprehensive emergency 
preparedness program that addresses all of the required elements. An 
emergency program could be implemented if an internal emergency 
occurred, such as a flood or fire in the facility, or if a community 
emergency occurred, such as a tornado, hurricane or earthquake. 
However, for the purpose of this rule, an emergency or a disaster is 
defined as an event that affects the facility or overall target 
population or the community at large or 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 (DHHS), or the President of the 
United States.
    An emergency plan is one part of a facility's emergency 
preparedness program. The plan provides the framework, which includes 
conducting facility-based and community-based risk assessments that 
will assist a facility in addressing the needs of their patient 
populations, along with identifying the continuity of business 
operations which will provide support during an actual emergency. In 
addition, the emergency plan supports, guides, and ensures a facility's 
ability to collaborate with local emergency preparedness officials. As 
a separate standard, facilities will be required to develop policies 
and procedures to operationalize their emergency plan. Such policies 
and procedures should include more detailed guidance on what their 
staff will need to develop and operationalize in order to support the 
services that are necessary during an actual emergency.
    Comment: Some commenters stated that the requirement to update the 
policies and procedures annually was excessive. Some suggested review 
only as needed, and several thought this requirement was burdensome. 
Some commenters suggested that the plan should only be reviewed after 
an emergency event occurred. A few suggested that only the necessary 
administrative personnel would need to review the plan according to 
their policy. Some commenters suggested that weather-related 
emergencies be reviewed and updated seasonally or quarterly.
    Response: We disagree that an annual update is excessive or overly 
burdensome. We believe it is good business practice to review and 
evaluate at least annually for revisions that will improve the care of 
patients, staff and local communities. It is important to keep facility 
staff updated and trained, as evidenced by policy and procedural 
updates often occurring not only as a result of an emergency that the 
facility experienced, but as has been noted in the local and 
international news. For example, there are various infections and 
diseases, such as the Ebola outbreak in October, 2014, that required 
updates in facility assessments, policies and procedures and training 
of staff beyond the directly affected hospitals. The final rule 
requires that if a facility experiences an emergency, an analysis of 
the response and any revisions to the emergency plan will be made and 
gaps and areas for improvement should be addressed in their plans to 
improve the response to similar challenges for any future emergencies.
    Comment: Some commenters viewed the organization of the emergency 
plan in the proposed rule as separate from the emergency preparedness 
policies and procedures. Some hospitals have an emergency plan that 
consists of emergency policies and procedures in a single document that 
is updated periodically. They recommended that CMS recognize that the 
plan may represent the policies and procedures.
    Response: The format of the emergency preparedness plan and 
emergency policies and procedures that a hospital or facility uses are 
at their discretion. However, it must include all the requirements 
included for the emergency plan and for the policies and procedures.
    Comment: A commenter questioned why mitigation was not included in 
the risk assessment process as part of the evaluation in reviewing the 
strategies used during an emergency as related to possible future 
similar events. The commenter noted that FEMA provides resources, 
including grant programs, for mitigation planning for communities. 
According to FEMA documents, assistance from local emergency management 
officials is available in identifying hazards in their community, and 
recommending options to address them. A few commenters recommended that 
we modify the regulation to include mitigation.
    Response: We understand the commenters' concerns, however our new 
emergency preparedness requirements focus on continuity of operations, 
not hazard mitigation, which refers to actions to reduce to eliminate 
long term risk to people and property from natural disasters. The 
emergency plan requires facilities to include strategies for addressing 
the identified emergency events that have been developed from the 
facility and the

[[Page 63877]]

community-based risk assessments. These strategies include addressing 
changes that have resulted from evaluating their risk assessment 
process. We decided to not include specific mitigation requirements as 
part of the emergency plan and instead, base the plan on using an all-
hazards approach which can include mitigation activities to lessen the 
severity and impact a potential disaster or emergency can have on a 
health facility's operation. Facilities can choose to include hazard 
mitigation strategies in their emergency preparedness plan. However, we 
have not made hazard mitigation a requirement. We refer commenters that 
are interested in hazard mitigation to the following resources for more 
information:
     National Mitigation Framework: http://www.fema.gov/national-mitigation-framework.
     FEMA Hazard Mitigation Planning: http://www.fema.gov/hazard-mitigation-planning.
    Comment: Commenters agreed that a hospital should evaluate both 
community-based and facility-based risks but did not believe that CMS 
provided enough clarity about which entity is expected to conduct the 
community-based risk assessment. It is unclear whether CMS would expect 
a hospital to conduct its own assessment outside of the hospital or 
rely on an assessment developed by entities, such as regional 
healthcare coalitions, public health agencies, or local emergency 
management. The commenters suggested that CMS allow hospitals to 
develop a hazard vulnerability risk assessment by a different 
organization if deemed adequate or conduct their own assessment with 
input from key organizations as is consistent with TJC and NFPA[supreg] 
standards.
    Response: We agree that a hospital could rely on a community-based 
assessment developed by other entities, such as their public health 
agencies, emergency management agencies, and regional healthcare 
coalitions or in conjunction with conducting its own facility-based 
assessment. We would expect the hospital to have a copy of this risk 
assessment and to work with the entity that developed it to ensure that 
the hospital emergency plan is in alignment.
    Comment: Some commenters questioned if the proposed rule would 
allow an aggregation of risk assessments for multiple sites.
    Response: As discussed previously, we are allowing integrated plans 
for integrated health systems. Please refer to the ``Integrated health 
Systems'' section of this final rule for further information.
    Comment: Some commenters thought ``The National Planning 
Scenarios'' discussed in the proposed rule were a good tool, but the 
risk assessment developed at the organizational level should be the 
driving force behind the emergency plan. It was recommended that we 
clarify that the scenarios are merely variables that could be 
considered in addition to the organization's risk assessment of 
potential local threats.
    Response: We agree with the commenters. In accordance with Sec.  
482.15(a)(1), the hospital must develop an emergency plan based on a 
risk assessment. As stated in the proposed rule, The National Planning 
Scenarios were suggested as a possible tool that facilities could 
consider in the development of their emergency plan along with the 
development of the facility and community risk assessments.
    Comment: Some commenters believed the examples listed in the 
preamble addressing patient populations, including persons at-risk, 
were not comprehensive enough and requested that more categories be 
included. Some stated that a ``patient population'' included all 
patients; otherwise, they would not be in a facility receiving 
treatment or care. The commenters suggested that at-risk populations 
(geriatric, pediatric, disabled, serious chronic conditions, 
addictions, or mental health issues) served in all provider settings 
receive similar emphasis in guidance. A commenter stated that the at-
risk definition should be limited to those persons who are identified 
by statute or who are assessed by the provider as being vulnerable due 
to physical and cognitive functioning impairments. Some commenters were 
concerned that the wording of the regulation could create the 
expectation that hospitals would be required to care for all 
individuals in the community who had additional needs. They believed 
community-wide planning should ensure that alternate locations be 
established for such things as individuals dependent on medical 
equipment that requires electricity for recharging their equipment. 
Some commenters suggested adding language ``of providing acute medical 
care and treatment in an emergency to describe the services that they 
will have the ability to provide to their patient population.''
    Response: In the proposed rule, several types of patient 
populations were described as at-risk. More examples would have 
required an exhaustive list and even then, not all categories would 
have been included. Other suggested categories, as set out in the 
comment, could be included in the individual facility's assessments and 
would not be limited to the examples listed in the proposed rule.
    As is often the case, in times of emergency, people seek assistance 
at general hospitals for such things as charging batteries for their 
medical equipment, and obtaining medical supplies such as oxygen, which 
they need for their care. The commenters' suggestion that community-
wide alternate locations be established to handle these needs would 
need to be arranged with their local emergency preparedness officials. 
To facilitate that, the proposed rule requires a process for ensuring 
cooperation and collaboration with local, tribal, regional, state, and 
federal emergency preparedness officials in order to ensure an 
integrated response during a disaster or emergency situation. 
Facilities are encouraged to participate in a local healthcare 
coalition as it may provide assistance in planning and addressing 
broader community needs that may also be supported by local health 
department and emergency management resources. Facilities may include 
establishing community-wide alternate locations in their facility plan. 
Individual facilities would not be expected to take care of all the 
needs in the community during an emergency.
    Comment: Several commenters stated that we did not require 
facilities to evaluate strategies for addressing surge capacity within 
the initial risk assessment. They suggested that we require facilities 
to address surge capacity in their emergency plans. Another commenter 
stated that facilities should develop specialized plans to address the 
needs of their patients with disabilities or who are medically 
dependent (for example, patients requiring dialysis or ventilator).
    Response: We believe that an emergency preparedness plan based on 
an all-hazards risk assessment would include plans for the potential of 
surge activities during an emergency. The emergency plan should also 
consider the needs of the entire patient and staff populations.
    Comment: Commenters requested clarification about what is meant by 
``type of services'' the provider/suppliers have the ability to provide 
in an emergency.
    Response: Based on the emergency situation and the facility's 
available resources, a facility would need to assess its capabilities 
and capacities in order to determine the type of care and treatment 
that could be offered at that

[[Page 63878]]

time based on its emergency preparedness plan.
    Comment: Some facilities questioned how they could 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. Some commenters stated that they already had this 
requirement in their states' regulations and were already familiar with 
the process. Many commenters believed the term ``ensuring'' was too 
onerous for providers and suppliers and CMS did not take into 
consideration that the State and local emergency officials also had 
responsibilities. A commenter suggested adding language: ``with the 
goal of implementing 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.'' Several commenters 
recommended replacing the word ``ensure'' with the words ``strive 
for.'' Some believed this requirement was important but with limited 
funds available, implementation would be excessively burdensome.
    Response: As noted previously, some commenters stated that they 
were already familiar with the process for ensuring cooperation and 
collaboration with various levels of emergency preparedness officials. 
Providers and suppliers must document efforts made by the facility to 
cooperate and collaborate with emergency preparedness officials. While 
we are aware that the responsibility for ensuring a coordinated 
disaster preparedness response lies upon the state and local emergency 
planning authorities, we have stated previously in this rule that 
providers and suppliers must document efforts made by the facility to 
cooperate and collaborate with emergency preparedness officials. Since 
some aspects of collaborating with various levels of government 
entities may be beyond the control of the provider/supplier, we have 
stated that these facilities must include in their emergency plan a 
process for cooperation and collaboration with local, tribal, regional, 
state, and federal emergency preparedness officials.
    Comment: A commenter suggested that CMS take into account potential 
language barriers that may occur in rural areas during an emergency. 
The commenters recommended that CMS include a requirement for a formal 
interpreter to interact with non-English speaking patients during an 
emergency.
    Response: Facilities are required to have an emergency preparedness 
plan that addresses the usual patient population of the community the 
hospital serves. In addition, certified Medicare providers and 
suppliers are required to provide meaningful access to Limited English 
Proficient (LEP) persons under the provider agreement and supplier 
approval requirement (Sec.  489.10), to comply with Title VI of the 
Civil Rights Act of 1964. Title VI requires Medicare participants to 
take reasonable steps to ensure meaningful access to their programs and 
activities by LEP persons.
    Comment: A commenter stated that the risk assessment should include 
the availability of emergency power or a plan for ensuring emergency 
power with the owner of a building in which the facility operates when 
a facility is not owned by the provider.
    Response: It is the responsibility of the healthcare provider that 
is renting a facility to discuss issues of ensuring that they can 
continue to provide healthcare during an emergency if the structure of 
the building and its utilities are impacted. We would expect providers 
to include this in their risk assessment. As discussed in the next 
section, we require facilities to develop policies and procedures to 
address alternate sources of energy.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     Revising the introductory text of Sec.  482.15 by adding 
the term ``local'' to clarify that hospitals must also coordinate with 
local emergency preparedness systems.
     Revising Sec.  482.15(a)(4) to remove the word 
``ensuring'' and replacing the word ``ensure'' with ``maintain.''
2. Policies and Procedures (Sec.  482.15(b))
    We proposed 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). We proposed that these policies and 
procedures be reviewed and updated at least annually.
    We proposed 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 Sec.  482.15(b)(1)(i), food, water, 
and medical supplies. We noted that the 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 
proposed that a hospital's policies and procedures also address how the 
subsistence needs of patients and staff that were evacuated would be 
met during an emergency.
    At Sec.  482.15(b)(1)(ii) we proposed 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; and (3) fire detection, extinguishing, and alarm 
systems. At Sec.  482.15(b)(1)(ii)(D), we proposed that the hospital 
develop policies and procedures to address the provisions of sewage and 
waste disposal including solid waste, recyclables, chemical, biomedical 
waste, and waste water.
    At Sec.  482.15(b)(2), we proposed 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 stated that it is imperative that the hospital be able to 
track a patient's whereabouts, to ensure adequate sharing of patient 
information with other facilities 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. We did not propose a requirement for a 
specific type of tracking system. We believed that a hospital should 
have the flexibility to determine how best to track patients and staff, 
whether it uses an electronic database, hard copy documentation, or 
some other method. However, we stated that 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 and included in their policies and 
procedures.
    We proposed at Sec.  482.15(b)(3) that a hospital have policies and 
procedures in place to ensure 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

[[Page 63879]]

external sources of assistance. We proposed at Sec.  482.15(b)(4) that 
a hospital have policies and procedures to address a means to shelter 
in place for patients, staff, and volunteers who remain in the 
facility. We indicated that we would expect that hospitals include in 
their policies and procedures both the criteria for selecting patients 
and staff that would be sheltered in place and a description of how 
they would ensure their safety.
    We proposed 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 are secure and 
readily available during an emergency. In addition to the current 
hospital requirements for medical records located at Sec.  482.24(b), 
we proposed that hospitals be required to ensure that patient records 
are secure and readily available during an emergency. We indicated that 
such policies and procedures would have to be in compliance with Health 
Insurance Portability and Accountability Act (HIPAA) Rules at 45 CFR 
parts 160 and 164, which protect the privacy and security of an 
individual's protected health information. We proposed at Sec.  
482.15(b)(6) that facilities 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 healthcare professionals to address surge 
needs during an emergency.
    We proposed at Sec.  482.15(b)(7) that hospitals have a process for 
the development of arrangements with other hospitals and other 
facilities to receive patients in the event of limitations or cessation 
of operations at their facilities, to ensure the continuity of services 
to hospital patients. This requirement would apply only to facilities 
that provide continuous care and services for individual patients; 
therefore, we did not propose this requirement for transplant centers, 
CORFs, OPOs, clinics, rehabilitation agencies, and public health 
agencies that provide outpatient physical therapy and speech-language 
pathology services, or RHCs/FQHCs.
    We also proposed 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 identified by emergency management officials. We proposed this 
requirement for inpatient providers only. We stated that we would 
expect that state or local emergency management officials might 
designate such alternate sites, and would plan jointly with local 
facilities on issues related to staffing, equipment and supplies at 
such alternate sites. This requirement encourages providers to 
collaborate with their local emergency officials in 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 healthcare 
providers to ensure that sufficient healthcare 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, healthcare 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). Additional information regarding the 1135 waiver 
process is provided in the CMS Survey and Certification document 
entitled, ``Requesting an 1135 Waiver'', located at: http://www.cms.gov/About-CMS/Agency-Information/H1N1/downloads/requestingawaiver101.pdf.
    Comment: A commenter stated that we should clarify that if a 
hospital is destroyed in an emergency but personnel are present with 
the relevant expertise, then personnel may function within their scope 
of practice in a makeshift location.
    Response: We agree that if a hospital is destroyed in an emergency, 
the medical personnel of that hospital should be able to function 
within their scope of practice in an alternate care site to provide 
valuable medical care. The hospital and other inpatient providers 
should address this issue in their policies and procedures. These 
providers, in accordance with section 1135 of the Act, should have 
policies and procedures for the provision of care and treatment at an 
alternate care site identified by emergency management officials. We 
would expect that state or local emergency management officials would 
plan jointly with local facilities on issues related to staffing, 
equipment and supplies at such alternate sites.
    The comments we received on our proposed requirement for hospitals 
to develop and implement emergency preparedness policies and procedures 
are discussed later in this final rule. We also proposed that all 
providers and suppliers review and update their policies and procedures 
at least annually. We received a few comments on this issue.
    Comment: A few commenters indicated that a requirement for annual 
updates to the policies and procedures is the most feasible for 
facilities. A commenter stated that annual updates are not only 
reasonable, but also necessary in order to ensure that emergency plans 
and procedures are adequate and current. Other commenters stated that a 
stricter requirement, for example of bi-annual updates, would be 
burdensome and unrealistic for facilities to meet. Still other 
commenters stated that the requirement to update policies and 
procedures annually was excessive and burdensome. Some suggested review 
on an ``as needed'' basis instead. Some suggested that weather-related 
emergencies be reviewed and updated seasonally or quarterly.
    Response: We appreciate the feedback from commenters and we agree 
that requiring annual updates is effective and the most realistic 
expectation of facilities. We do not agree that an annual update is 
excessive or overly burdensome. It is important to keep facility staff 
updated and trained on emergency policies and procedures regardless of 
whether the facility has experienced an actual emergency. For example, 
various infections and diseases, such as the Ebola outbreak in October 
2014, have required updates in facility assessments, policies and 
procedures, and training of staff to ensure the health and safety of 
their patients and employees. Facilities are free to update as needed 
but at least annually.
    Comment: Most commenters believed that providing for the 
subsistence needs of patients and staff was appropriate but only if 
sheltering in place. If patients were evacuated, the receiving facility 
should be responsible for those needs. Some commenters believed that 
community organizations, and local emergency management agencies should 
provide for subsistence needs when patients are sent to the receiving 
facilities. Some commenters questioned other agencies'/organizations' 
requirements and how that would impact their current requirements; some 
questioned whether certain amounts were sufficient and many were 
concerned about the burden with many facilities operating on limited 
budgets. Other commenters suggested we should require facilities to 
have a minimum store of provisions to meet the needs of

[[Page 63880]]

their patient or resident populations for 72 to 96 hours. The 
commenters stated that we should clarify the amount of time to provide 
subsistence during and after an emergency. Other commenters stated that 
we should not mandate specific subsistence needs and quantities and a 
few commenters stated that we should delete the requirement for a 
hospital to provide subsistence in the event of an evacuation.
    Response: We would first like to point out that we are requiring 
certain facilities to have policies and procedures to address the 
provision of subsistence in the event of an emergency. This does not 
mean that facilities would need to store provisions themselves. We 
agree that once patients have been evacuated to other facilities, it 
would be the responsibility of the receiving facility to provide for 
the patients' subsistence needs. Local, state and regional agencies and 
organizations often participate with facilities in addressing 
subsistence needs, emergency shelter, etc. Secondly, we are not 
specifying the amount of subsistence that must be provided as we 
believe that such a requirement would be overly prescriptive. 
Facilities can best manage this based on their own facility risk 
assessments. We disagree with setting a rigid amount of subsistence to 
have on hand at any given time in the event of an emergency. Based on 
our experience with inpatient healthcare facilities to allow each 
facility the flexibility to identify the subsistence needs that would 
be required during an emergency, mostly likely based on level of 
impact, is the most effective way to address subsistence needs without 
imposing undue burden.
    Comment: In response to a solicitation of public comments in the 
proposed rule, almost all the facility commenters stated that they did 
not see subsistence preparations for individuals residing in the larger 
community as their responsibility. The commenters stated that local and 
state emergency management personnel along with civic organizations 
such as the Red Cross should be responsible for meeting these needs. In 
addition, the cost for the facilities to provide these services to the 
community would be unsustainable. Some commenters interpreted the 
proposed regulation text to not only include responsibility for 
patients and staff in the facility, but also individuals in the 
community.
    Response: We agree with the commenters and did not mean to suggest 
that facilities are also responsible for individuals in the community. 
While we believe it would be a good practice to prepare for these 
``community individuals,'' we are not requiring it under Sec.  
482.15(b)(1). The provision on subsistence needs applies only for staff 
and patients.
    Comment: Commenters suggested that we add ``pharmaceuticals or 
medications'' to provisions of food, water and medical supplies.
    Response: We agree with the commenters' suggestion and have added 
pharmaceuticals to the list of subsistence needs in the regulation 
text.
    Comment: A commenter questioned why supplies, such as personnel, 
power, water, and finances, are not addressed in relation to 
subsistence needs in the proposed rule. The commenter noted that the 
requirements do not include how these supplies will be sustained during 
emergency situations.
    Response: We have included requirements that facilities develop and 
maintain emergency preparedness policies and procedures that address 
subsistence needs for staff and patients at Sec.  482.15(b)(1). 
However, we believe the rule allows flexibility so that facilities can 
determine how they will acquire provisions and use them for the needs 
of patients and staff.
    Comment: A commenter stated that we should delete the requirement 
we proposed 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. The commenter 
inquired about what a hospital should do with the patients that they 
decide are not going to be sheltered in place and rescue crews cannot 
make it to the hospital to remove them.
    Response: Plans should be made to shelter all patients in the event 
that an evacuation cannot be executed. We state at Sec.  482.15(b)(1) 
that provisions should be made for patients and staff whether they 
evacuate or shelter in place. However, with advance notice in event of 
an emergency, it may be medically necessary for some of the patient 
population to be evacuated in advance. During an emergency, often the 
hospital may be the only available resource to patients and are the 
focal points for healthcare in their respective communities. 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. 
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 
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. Relief staff may be 
unable to get to the hospital thus requiring staff to remain at the 
hospital for indefinite periods of time. We disagree with removing the 
requirement for facilities to make the necessary plans to provide food, 
water, medical supplies, and subsistence needs for the patients, staff, 
and volunteers who remain in the facility. As we have noted previously, 
the policy only requires that the hospital have policies to provide for 
subsistence needs, which we believe are not unduly burdensome. We are 
not setting minimum requirements or standards for these provisions in 
hospitals.
    Comment: A commenter recommended that we require the electronic 
monitoring of fire extinguishers. The commenter stated that this 
requirement would address the widespread non-compliance of fire 
extinguisher code regulations. Another commenter disagreed with the use 
of electronic monitoring of fire extinguishers, arguing that 
retrofitting fire extinguishers with this technology would be costly.
    Response: This recommendation is not within the scope of this 
regulation. For additional information we refer readers to our current 
Life Safety Code regulations (for hospitals, Sec.  482.41(b)).
    Comment: In addition to the general comments discussed earlier that 
we received regarding our proposal for certain providers and suppliers 
to track staff and patients during and after an emergency, we also 
received a few comments specific to the tracking requirement for 
hospitals. Many questioned the complexity of the tracking documentation 
and what information would be needed. Some commenters stated that 
patient tracking within the hospital should be distinguished from 
tracking patients outside of the hospital, in the hospital's care, or 
whether they are located at an alternate care site operated by the 
hospital. Moving and tracking of patients may also be the 
responsibility of an entity other than the hospital, such as state and 
emergency management officials and the hospitals may not know the 
destination of the individuals. Some commenters requested clarification 
regarding what we mean by a ``system to track.''
    Commenters noted that the facility's tracking system may not be 
compatible with the hospital's IT system. If the system lacks 
interoperability, it becomes difficult to share information across the 
emergency management system.

[[Page 63881]]

Commenters suggested that CMS change the current language and instead 
add ``a hospital would be required to have a process to locate staff 
and track the location of patients in the hospital's care both during 
and throughout the emergency.'' Some commenters interpreted the 
proposed requirement to include the hospital's responsibility of 
tracking the whereabouts of patients in outpatient facilities (assuming 
they are part of the hospital). These commenters recommended that CMS 
remove this requirement.
    Response: We appreciate the commenters' feedback and have clarified 
our expectations. As indicated previously, we have removed ``after the 
emergency'' from the regulation text. Furthermore, we are revising the 
regulation text to clarify that we would expect facilities to track 
their on-duty staff and sheltered patients during an emergency and 
document the specific location and name of where a patient is relocated 
to during an emergency (that is, to another facility, home, or 
alternate means of shelter, etc.). As we stated in the proposed rule, 
we did not propose a requirement for a specific type of tracking 
system. By ``system to track'' we mean that facilities will have the 
flexibility to determine how best to track patients and staff, whether 
they utilize an electronic database, hard copy documentation, or some 
other method. We would expect that the information would be readily 
available, accurate, and shareable among officials within and across 
the emergency response system, as needed, in the interest of the 
patient.
    Comment: Some commenters questioned who would assign evacuation 
locations outside the facility if it was determined necessary. If 
internal, they believe the provider or supplier should decide.
    Response: Decisions about evacuation locations within a facility 
should be made by the provider or supplier. If patients must be 
evacuated outside of the facility, a joint decision could be made by 
the facility and the local health department and emergency management 
officials.
    Comment: Several commenters stated that the same transportation 
services may be planned for use by several facilities and that planning 
should consider multiple options in the event of an evacuation.
    Response: We agree with the commenters. We suggest that facilities 
consider identifying potential redundant transportation options and 
collaborate with healthcare coalitions to better inform and assist in 
planning activities for the efficient and effective use of limited 
resources.
    Comment: Some commenters questioned our proposal to shelter 
volunteers and voiced concern about their legal responsibilities. A 
commenter stated that it would be challenging for some facilities to 
provide shelter for patients, staff, and volunteers who remain in the 
facility. Commenters expressed concern in response to our proposal that 
hospitals' ``shelter-in-place'' policies include both the criteria for 
selecting patients and staff that would be sheltered, and a description 
of how they would ensure their safety. Some commenters stated that this 
appeared to lack significant evidence of being an effective policy. The 
commenters questioned what we expected a hospital to do with the 
patients that the hospital decides not to shelter in place, if rescue 
crews could not make it to the hospital to remove them. Other 
commenters believed hospitals should prepare to shelter in place all 
patients, staff, and visitors. The commenters recommended that CMS 
modify its proposal to permit hospitals to decide which patients and 
staff to shelter.
    Response: We agree that sheltering in place can be a challenge to 
facilities. However, the emergency plan requires strategies for 
addressing this issue in the facility risk assessment. As such, we 
disagree with revising our policy for sheltering in place. We require 
facilities to have a means to shelter in place for patients, staff, and 
volunteers who remain in the facility. Based on its emergency plan, a 
hospital could decide to have various approaches to sheltering some or 
all of its patients, staff and visitors. The plan should take into 
account the available beds in the area to which patients could be 
transferred in the event of an emergency. For example, if it is risky 
or the emergency affects available sites for transfer or discharge, 
then the patients would remain in the facility until it was safe to 
transfer or discharge. Also, we would expect providers and suppliers to 
have policies and guidelines for sheltering volunteers and visitors 
during an emergency. Facilities must determine their policies based on 
the emergency and the types of visitors/volunteers that may be present 
during and after an emergency.
    Comment: Some commenters questioned if the system of medical 
documentation has to be electronic. Some stated that they already have 
this in place in their facilities. Many stated that electronic health 
records (EHRs) are not used universally and, if required, would be 
unrealistic to put into operation for this requirement and would be 
burdensome to their overall fiscal operation. Many commenters believed 
multiple IT systems would be incompatible. Some commenters pointed out 
that if power were lost, they would lose the ability to copy records 
and use computers to access patient records. Some facility commenters 
stated that they use paper documents (pre-printed forms) that document 
relevant patient information and attach them to patients during an 
evacuation. A commenter believed that some facilities would find it 
difficult to provide a system of medical documentation that would 
ensure that medical records were complete, confidential, secure, and 
readily available. The same commenters stated that it would also be 
challenging for them to share medical documentation and relevant 
patient information with other healthcare facilities to ensure 
continuity of healthcare and treatment during an emergency.
    Response: We are not requiring EHRs as part of the medical record 
documentation requirements. Medicare- and Medicaid-participating 
facilities are in varying stages of EHR adoption, and therefore, many 
would be unable to electronically share relevant patient care 
information with other treating healthcare facilities during an 
emergency. However, we do expect facilities to be able to provide a 
means to preserve and protect patient records and ensure that they are 
secure, in order to provide continuity in the patient's care and 
treatment. We would expect facilities' plans to address how a provider, 
in the event of an evacuation, would release patient information, as 
permitted under 45 CFR 164.510 of the HIPAA Privacy Rule. This section 
of the HIPAA Privacy Rule sets out ``Uses and disclosures requiring an 
opportunity for the individual to agree or to object.'' Facilities 
should establish an effective communication system, in accordance with 
the HIPAA Privacy Rule, that could generate timely, accurate 
information that can be disseminated, as permitted, to family members 
and others. Facilities should also consider including in their 
communication plan information on what type of patient information is 
releasable and who is authorized to release this information during an 
emergency. Additional information and resources regarding the 
application of the HIPAA Privacy Rule during emergency scenarios can be 
located at: http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/.
    Comment: Some commenters stated that the development of 
arrangements with hospitals or other providers and

[[Page 63882]]

suppliers to receive patients in the event of limitation of services, 
so as to assure continuity of services, was unrealistic, due to limited 
availability of resources (that is, other hospitals or facilities may 
be experiencing limitation of services or there are no other providers 
or suppliers in the area).
    Response: We understand that during an emergency other available 
healthcare resources may be strained, but the development of 
arrangements in collaboration with other facilities to receive patients 
is necessary in order to provide the continued needed care and 
treatment for all patients. If arranged resources are unavailable 
during an emergency, then the facility should use the available 
resources in its community. Facilities are encouraged to participate 
with its local healthcare coalition to gain a broader understanding of 
other facilities and potential resources, both facility and community, 
that may be available during an emergency.
    Comment: Some commenters stated that any alternate care site should 
be identified either by the provider or supplier alone or in 
conjunction with the emergency management officials. A few commenters 
questioned the legal responsibilities of the staff working at the 
alternate care site. Some commenters questioned the effect of a waiver 
on their reimbursement process. Many questions and concerns about 
staffing responsibilities were related to who would make staffing 
decisions and who would pay alternate care site salaries. Some 
commenters stated that the staff could not be spared from their 
facilities even in emergency circumstances.
    Response: Health department and emergency management officials, in 
collaboration with facility staff, would be responsible for determining 
the need to establish an alternate care site as part of the delivery of 
care during an emergency. The alternate care site staff would be 
expected to function in the capacity of their individual licensure and 
best practice requirements and laws. Professional staff normally 
carries malpractice insurance and facilities also have malpractice 
insurance, which would also include coverage for their employees. 
Decisions regarding staff responsibilities would be determined based on 
the facility- and community-based assessments and the type of services 
staff could provide. This regulation does not address payment issues.
    Comment: Many commenters stated that they would be unable to 
provide or obtain alternative sources of energy during an emergency. 
They questioned who would decide what are acceptable types of energy 
sources (such as propane or battery-operated) and what service needs 
could be met, such as operating rooms, emergency departments, and 
surgical and intensive care units. Several commenters recommended that 
CMS state how long a hospital would be expected to provide alternative 
or backup power.
    Response: Alternate sources of energy depend on the resources 
available to a facility, such as battery-operated lights, propane 
lights, or heating, in order to meet the needs of a facility during an 
emergency. We would encourage facilities to confer with local health 
department and emergency management officials, as well as and 
healthcare coalitions, to determine the types and duration of energy 
sources that could be available to assist them in providing care to 
their patient population during an emergency. As part of the risk 
assessment planning, facilities should determine the feasibility of 
relying on these sources and plan accordingly.
    Comment: Some commenters stated that alternate sources of energy to 
maintain temperatures for patient health and safety may not be 
realistic to achieve because their emergency systems may already have 
pre-planned areas of need, such as use in the emergency department, 
operating rooms, intensive care units, and necessary medical life 
sustaining needs, such as ventilators, oxygen and intravenous 
equipment, and cardiac monitoring equipment. In clinical care areas of 
facilities, patients may have to be moved, fans may have to be brought 
in or temperature control may be outside of the facility's control 
entirely. Temperatures to maintain safe and sanitary storage of 
provisions may not be viable due to limited backup power. Commenters 
recommended that these requirements be aligned with the current 
NFPA[supreg] standards. Commenters recommended that we require 
hospitals to describe in their emergency plans how they will mitigate 
specific scenarios, such as if they are unable to maintain temperatures 
or refrigeration. In addition, they review their current emergency 
power capacity and assess whether upgrades should be made. The 
commenters stated that CMS' proposed rule could be interpreted as 
increasing requirements on electrical systems and require upgrades to 
those systems, which could be costly to accomplish.
    Response: We understand that protocols for emergency distribution 
of energy within a facility may have already been set to accommodate 
such priorities as emergency lighting, fire detection, alarm systems, 
and providing life-sustaining care and treatment. We agree with the 
commenters that facilities should include as part of their risk 
assessment how specific needs will be met to maintain temperatures to 
protect patient health and safety. We are not requiring facilities to 
upgrade their electrical systems, but after their review of their 
facility risk assessment, facilities may find it prudent to make any 
necessary adjustments to ensure that patients' health and safety needs 
are met and that facilities maintain safe and sanitary storage areas 
for provisions.
    Comment: Many commenters expressed concern about their perception 
that they would be held responsible for maintaining sewage and waste 
disposal in their facility during and after an emergency event. The 
commenters thought that such matters were outside their scope of 
responsibilities. Some thought our expectations were unclear. Some 
commenters noted that energy is not always required for these 
processes. A commenter stated that in some emergencies, infrastructure 
could be damaged, backup power could be unavailable, local water and 
sewage services could be limited or unavailable, or their hazardous 
waste disposal contractors could be unavailable. Other commenters 
recommended that CMS require hospitals to have backup plans if their 
primary waste-handling operations become disabled or disrupted, which 
could include storing waste in a secure area until the facility 
arranged removal. The commenters also recommended that hospitals 
identify and assess the risks in their risk assessments relating to 
their facility's wastewater system and describe in their emergency plan 
how they would address specific scenarios in which sewage might become 
a problem. Several commenters stated that the treatment of sanitary 
sewage on site would possibly require the installation of an onsite 
sewage treatment plant if the municipal system were disrupted, which 
would be impossible for inner city facilities due to limited physical 
space. Commenters stated that the proposed rule seemed to require that 
waste continue to be disposed of in a disaster, and that the proposed 
rule was too broad.
    Response: We agree with the commenters' recommendation that 
facilities should identify and assess their sewage and wastewater 
systems as part of their facility-based risk assessment and make 
necessary plans to maintain these services. We are not requiring onsite 
treatment of sewage but

[[Page 63883]]

that facilities make provisions for maintaining necessary services.
    Comment: A commenter stated that CMS should revise the requirement 
at Sec.  482.15(b)(6) to state ``use of health care volunteers'' to 
clarify that this requirement is different from the requirement for the 
use of ``general'' volunteers.
    Response: The intent of this requirement is to address any 
volunteers. We believe that in an emergency a facility or community 
would need to accept volunteer support from individuals with varying 
levels of skills and training and that policies and procedures should 
be in place to facility this support. Health care volunteers would be 
allowed to perform services within their scope of practice and training 
and non-medical volunteers would perform non-medical tasks. As such, we 
disagree with limiting this requirement to just medical volunteers.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     Revising Sec.  482.15(b)(1)(i) to add that hospitals must 
have policies and procedures that address the need to stock 
pharmaceuticals during an emergency.
     Revising Sec.  482.15(b)(2) to remove the requirement for 
hospitals to track staff and patients after an emergency and clarifying 
that in the event staff and patients are relocated, hospitals must 
document the specific name and location of the receiving facility or 
other location for sheltered patients and on-duty staff who leave the 
facility during the emergency.
     Revising Sec.  482.15(b)(5) to change the phrase ``ensures 
records are secure and readily available'' to ``secures and maintain 
availability of records.''
     Revising Sec.  482.15(b)(5) and (7) to remove the word 
``ensure.''
     Adding a new Sec.  482.15(f) to allow a separately 
certified hospital within a healthcare system to elect to be a part of 
the healthcare system's emergency preparedness program.
3. Communication Plan (Sec.  482.15(c))
    An effective and well maintained communication plan will facilitate 
coordinated patient care across healthcare providers, and with state 
and local public health departments and emergency systems to protect 
patient health and safety in the event of a disaster. For a hospital to 
operate effectively in an emergency situation, we proposed at Sec.  
482.15(c) that hospitals be required to develop and maintain an 
emergency preparedness communication plan that complies with both 
federal and state law. We proposed that hospitals be required to review 
and update the communication plan at least annually. During an 
emergency, it is critical that hospitals, and all providers/suppliers, 
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. Updating the plan annually would facilitate effective 
communication during an emergency. Providers and suppliers are 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 across healthcare providers, and with 
state and local public health departments and emergency systems to 
protect patient health and safety in the event of a disaster.
    At Sec.  482.15(c)(1), we proposed that the communication plan 
include names and contact information about staff, entities providing 
services under arrangement, patients' physicians, other hospitals, and 
volunteers. We stated that, 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 proposed at Sec.  482.15(c)(2) to require 
hospitals to have contact information for federal, state, tribal, 
regional, or local emergency preparedness staff and other sources of 
assistance.
    We proposed at Sec.  482.15(c)(3) to require that hospitals have 
primary and alternate means for communicating with the hospital's staff 
and federal, state, tribal, regional, or local emergency management 
agencies.
    We also proposed at Sec.  482.15(c)(4) to require that hospitals 
have a method for sharing information and medical documentation for 
patients under the hospital's care, as necessary, with other healthcare 
facilities to ensure continuity of care.
    We proposed 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 Rule. 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. We believe this requirement would best be 
applied only to facilities that provide continuous care to patients, as 
well as to those facilities that take responsibility for and have 
oversight over or both, care of patients who are homebound or receiving 
services at home.
    We proposed at Sec.  482.15(c)(6) to require 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 Rule. 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 did not propose prescriptive requirements for how a 
hospital would comply with this requirement. Instead, we stated that we 
would allow hospitals the flexibility to develop and maintain their own 
system. Lastly, we proposed 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.
    Comment: Many commenters expressed support for the proposal to 
require hospitals to develop and maintain an emergency preparedness 
communication plan that complies with both federal and state law and is 
reviewed and updated annually. A commenter noted that the proposed 
requirements are consistent with TJC standards. The commenter noted 
that while they believe that these requirements can be met by larger 
institutions with ease, smaller institutions may have more 
difficulties.
    A few commenters disagreed with the proposal to require that 
communications plans have contact information for all staff physicians, 
families, patients, and contractors. A commenter stated that this would 
require an additional full time equivalent (FTE) staff member. Another 
commenter stated that it would be challenging and overly burdensome to 
maintain a current contact list, especially for volunteers.
    A commenter stated that it could be difficult for children's 
hospitals to maintain a comprehensive list of people and entities, as 
required for a hospital's communication plan. The commenter gave an 
example of a hospital that maintains a listing for most managers

[[Page 63884]]

and above, but not for all general staff and volunteers.
    Response: We appreciate the commenters' support and feedback. We 
disagree with the commenters who suggested that it would be overly 
burdensome for hospitals to maintain a current contact list. As a best 
practice, most hospitals maintain an up-to-date list of their current 
staff for staffing directories and human resource management. In 
addition, most hospitals have procedures or systems in place to handle 
their roster of volunteers. We believe that a hospital would have a 
comprehensive list of their staff, given that these lists are necessary 
to maintain operations and formulate a payroll. In addition, we 
continue to believe that it is critically important that hospitals have 
a way to contact appropriate physicians treating patients, and entities 
providing services under arrangement, other hospitals, and volunteers 
during an emergency or disaster event to ensure continuation of patient 
care functions throughout the hospital and to ensure continuity of 
care.
    Furthermore, we clarify that we are not requiring hospitals to 
include in their communication plan contact information for the 
families of staff, or the families of patients who are not directly 
involved in the patient's care, or contractors not currently providing 
services under arrangement.
    Comment: A commenter recommended that CMS scale back the 
requirement for an alternate means of communication, in order to allow 
facilities more time to evaluate existing communications technology and 
to gradually build toward a more integrated and collaborative system as 
resources allow.
    Response: We do not believe that scaling back the requirements for 
an alternate means of communication to be used during an emergency 
would be beneficial to hospitals and their patients. As we have learned 
over the years, landline telephones are often inoperable for an 
extended period of time during and after disasters. Cell phones also 
can be unreliable and are often without reception during an emergency 
event, or are completely unusable due to a lack of cellular coverage in 
certain remote and rural areas. Therefore, it is appropriate and 
vitally important for hospitals to have some alternate means to 
communicate with their staff and federal, state and local emergency 
management agencies during an emergency. While we are not endorsing a 
specific alternate communication system or requiring the use of certain 
specific devices, we expect that facilities would consider using the 
following devices:
     Pagers.
     Internet provided by satellite or non-telephone cable 
systems.
     Cellular telephones (where appropriate). Facilities can 
also carry accounts with multiple cell phone carriers to mitigate 
communication failures during an emergency.
     Radio transceivers (walkie-talkies).
     Various other radio devices such as the NOAA Weather Radio 
and Amateur Radio Operators' (ham) systems.
     Satellite telephone communication system.
    Comment: A few commenters expressed support for the proposed 
language that requires that the hospital's communication plan include a 
method for sharing information and medical documentation for patients 
under the hospital's care, as necessary, with other healthcare 
facilities to ensure continuity of care. The commenters noted that the 
proposed language is flexible and does not require the use of any 
specific technology. The commenters recommended that CMS continue to 
use flexible language in the final rule and not require hospitals to 
use any specific technology. The commenters noted that, in many 
instances, hospitals would share information through paper-based 
documentation.
    Response: We appreciate the commenters' support. We reiterate that 
Sec.  482.15(c)(4) requires that facilities have a method for sharing 
information and medical documentation for patients under the hospital's 
care, as necessary, with other healthcare facilities to ensure 
continuity of care. As the commenters pointed out, we are not 
requiring, nor are we endorsing, a specific digital storage or 
dissemination technology. Furthermore, we note that we are not 
requiring facilities to use EHRs or other methods of electronic storage 
and dissemination. In this regard, we acknowledge that many facilities 
are still using paper-based documentation. However, we encourage all 
facilities to investigate secure ways to store and disseminate medical 
documentation during an emergency to ensure continuity of care.
    Comment: A few commenters objected to the requirement that 
hospitals have a method for sharing information and medical 
documentation for patients under the hospital's care. A commenter 
specifically objected to the sharing of medical records with other 
health systems. The commenter stated that it is difficult to share this 
information with facilities that have different systems. Another 
commenter stated that the expectation that hospitals will share 
clinical documentation is unrealistic. The commenter noted that many 
HHAs still operate with paper documentation, are stand-alone 
facilities, and do not coordinate with other healthcare systems or with 
other local facilities. The commenter stated that surveyors should be 
aware that the capability of facilities to communicate patient-specific 
clinical documentation to other facilities in the local healthcare 
system is likely to be limited.
    Response: We disagree with the commenters' statement that hospitals 
should not or cannot have a method for sharing information and medical 
documentation for patients during an emergency or disaster, as 
necessary. We believe that hospitals should have an established system 
of communication that would ensure that patient care information could 
be disseminated to other providers and suppliers in a timely manner, as 
needed, during an emergency or disaster.
    We have seen the importance of formulating this type of 
communication plan in the past to ensure continuity of care. Sharing 
patient information and documentation was found to be a significant 
problem during the 2005 hurricanes and flooding in the Gulf Coast 
states. In 2011, the ability to share information during the Joplin, 
Missouri tornado both electronically and via hard copy helped patient 
evacuations and continuity of care. In addition, during Hurricane Sandy 
in 2012, some hospitals reported receiving evacuated patients from a 
nearby hospital with little or no medical documentation (HHS OIG, 
Hospital Emergency Preparedness and Response During Super Storm Sandy. 
September 2014). In some cases, electronic medical records were 
unavailable and only oral patient histories could be provided. This 
lapse in medical documentation is detrimental to patient care. 
Therefore, we continue to believe that hospitals should include in 
their communication plan a method for sharing information and medical 
documentation for patients under the hospital's care, as necessary, 
with other healthcare providers to ensure continuity of care. We 
encourage hospitals and other providers and suppliers to engage in 
coalitions in their area for assistance in effectively meeting this 
requirement.
    We clarify that we are not requiring the use of EHRs within this 
regulation and we understand that some hospitals and other providers 
and suppliers may still be using paper medical records. However, we 
encourage these facilities to consider the use of alternative means of 
storing patient care information, to ensure that medical documentation 
is

[[Page 63885]]

preserved and easily disseminated during an emergency or disaster.
    Comment: A commenter recommended that the requirements pertaining 
to a method or means of sharing information include timelines for 
submission of such documentation to other healthcare providers or other 
entities as described in proposed Sec.  482.15(c)(4) through (6).
    Response: We do not believe that it is appropriate to include 
suggested timelines for facilities to share information and medical 
documentation for patients under the hospital's care in these emergency 
preparedness requirements. Instead, we believe that the facility should 
determine the appropriate timeline for the dissemination of information 
to other providers and pertinent entities. We have included the 
language ``as necessary'' in the regulations to allow facilities 
flexibility to share information and medical documents as needed to 
ensure continuity of care for patients during an emergency.
    Comment: A few commenters expressed concern about the language used 
in the preamble, which states that hospitals would share comprehensive 
patient care information. The commenters noted that the term 
``comprehensive information'' is not defined and suggested that CMS 
focus on relevant information that enables a care provider to determine 
what medical services and treatments are appropriate for each patient.
    Response: We agree with the commenters that facilities should share 
relevant patient information to ensure continuity of care for a patient 
in situations where a provider must evacuate. In addition, we note that 
while we did not propose to require that providers share comprehensive 
patient care information, we believe that relevant patient information 
includes, but is not limited to, the patient's presence or location in 
the hospital; personal information the hospital has collected on the 
patient for billing or demographic analysis purposes, such as name, 
age, address, and income; or information on the patient's medical 
condition. Although we have not specified requirements for timelines 
for delivering patient care information, we would expect that 
facilities would provide patient care information to receiving 
facilities during an evacuation, within a timeframe that allows for 
effective patient treatment and continuity of care.
    Comment: A commenter requested clarification on the proposal that 
requires hospital communication plans to include a means, in the event 
of an evacuation, to release patient information as permitted under 
current law.
    Response: In response to this public comment, we are clarifying 
that Sec.  482.12 (c)(5) requires that the hospital must have a means, 
in the event of an evacuation, to release patient information as 
permitted under 45 CFR 164.510(b)(1)(ii), which establishes permitted 
uses and disclosures of protected health information to notify a family 
member, a personal representative of the individual, or another person 
responsible for the individual's location, general condition, or death. 
We are also clarifying in parallel provisions of the regulation that 
RNHCIs, ASCs, hospices, PRTFs, PACE organizations, LTC facilities, ICF/
IID facilities, CAHs, CMHCs, and dialysis facilities must have a means, 
in the event of an evacuation, to release patient information as 
permitted under 45 CFR 164.510(b)(1)(ii).
    Facilities should establish an effective communication system, in 
accordance with the previously referenced provision of the HIPAA 
Privacy Rule that could generate timely, accurate information that can 
be disseminated, as permitted, to family members and others. Facilities 
should also consider including in their communication plan information 
on what type of patient information is releasable and who is authorized 
to release this information during an emergency.
    Comment: A commenter expressed concern over the financial burden 
that smaller institutions may incur when implementing a system for 
sharing information. The commenter noted that this burden may be 
reduced as more institutions move towards EHRs. Therefore, the 
commenter recommended a phased-in approach to implementing this 
requirement.
    Response: We understand the commenter's concern about the potential 
financial burden that smaller facilities may incur. However, we have 
not specified a method or a system for sharing patient information. 
These regulations enable facilities to develop procedures that best 
meet their needs and take into account their facility's resources. 
Additionally, we believe that many facilities already have basic 
emergency preparedness plans, which may reduce the cost of 
implementation.
    We encourage facilities to engage in healthcare coalitions in their 
area for assistance. We also refer facilities to the following Web 
sites for more information about emergency communication planning:

 http://transition.fcc.gov/pshs/emergency-information/guidelines/health-care.html
 http://www.dhs.gov/government-emergency-telecommunications-service-gets
 http://www.phe.gov/preparedness/planning/hpp/reports/documents/capabilities.pdf

    Comment: Several commenters expressed concern about the proposed 
provisions that would require hospitals to include 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). Commenters 
noted that hospitals should already have HIPAA compliance plans in 
place that would address emergency situations. They also noted that 
some states have stricter privacy laws than HIPAA and, therefore, the 
commenters recommended that the regulatory language include a phrase 
that states that facilities should comply with applicable state privacy 
laws in addition to HIPAA.
    A few commenters questioned if the HIPAA privacy laws would be 
relaxed or waived during an emergency. A commenter requested 
clarification on privacy rules in emergency situations across all 
providers and suppliers, first responders, and community aid 
organizations.
    Response: Section 482.15(c) states that hospitals must develop and 
maintain an emergency preparedness communication plan that complies 
with both federal and state law. This phrase is applicable to the 
requirement that hospitals should provide a means of providing 
information about the general condition and location of patients under 
the facility's care; therefore, hospitals are required to comply with 
both 45 CFR 164.510(b)(4) and all pertinent state laws. Several 
commenters recommended that the regulatory language include a phrase 
that states that facilities should comply with applicable state privacy 
laws in addition to HIPAA. We note that the requirement as currently 
written will require hospitals to comply with all pertinent state laws, 
including pertinent state privacy laws, and that it is not necessary to 
add additional language.
    HIPAA requirements are not suspended during a national or public 
health emergency. However, the HIPAA Privacy Rule specifically permits 
certain uses and disclosures of protected health information in 
emergency circumstances and for disaster relief purposes, as described 
in HHS guidance at http://www.hhs.gov/hipaa/for-

[[Page 63886]]

professionals/special-topics/emergency-preparedness/index.html. In 
addition, under section 9 of the Project Bioshield Act of 2004 (Pub. L. 
108-276), which added paragraph 1135(b)(7) to the Act, the Secretary of 
HHS may waive penalties and sanctions against facilities that do not 
comply with certain provisions of the HIPAA Privacy Rule if the 
President declares an emergency or a disaster and the Secretary 
declares a public health emergency.
    Facilities and their legal counsel should review the HIPAA Privacy 
Rule carefully before deciding to share patient information. We refer 
readers to the following resources for more information on the 
application of the HIPAA Privacy Rule during an emergency:

 http://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/
 http://www.hhs.gov/sites/default/files/emergencysituations.pdf
 http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/index.html

    Comment: A few commenters stated that the language set out in the 
proposed rule describing requirements for a hospital's communication 
plan would have broad implications for EHRs. The commenters noted that 
this regulation could result in facilities being deemed non-compliant 
for reasons outside of their control, since, as they argue, the 
industry does not have the ability to electronically transfer or share 
patient information and medical documentation in a disaster with other 
healthcare facilities in a HIPAA-compliant manner.
    Response: We appreciate the commenters concerns regarding the 
difficulties that facilities could experience with their EHRs' 
operability with non-EHR healthcare facilities during an emergency. We 
acknowledge that EHR technology is in varying stages of development 
throughout the provider and supplier communities and understand the 
ramifications of this when patient information and necessary medical 
documentation needs to be communicated during an emergency.
    If a facility using EHRs experiences an emergency where patient 
information needs to be communicated to a receiving facility that does 
not support an EHR system, alternate methods such as paper 
documentation or faxed information can be used. Facilities are 
encouraged to explore alternate means of communicating this 
information.
    The rule requires a method of sharing patient information and 
medical documentation to ensure continuity of care as part of their 
communication plan. Interpretive guidance for this regulation and 
subsequent surveyor training will be completed after the publication of 
this rule.
    Comment: A few commenters stated that Health Information Exchange 
(HIE) networks are in varying stages of development and, in some areas, 
no HIE network is available. Therefore, some of these commenters 
suggested that CMS work with the Office of the National Coordinator 
(ONC) to support policies that accelerate the development of a robust 
infrastructure for HIE networks.
    Response: We appreciate this feedback and agree with the 
commenters. CMS continues to work with the ONC to support and promote 
the adoption of health information technology and the nationwide 
development of HIE to improve healthcare. While we are not mandating 
the use of EHRs through this rule, we encourage facilities to consider 
the meaningful use of certified EHR technology to improve patient care.
    HHS has initiatives designed to encourage HIE among all healthcare 
providers, including those who are not eligible for the Electronic 
Health Record (EHR) Incentive Programs, and are designed to improve 
care delivery and coordination across the entire care continuum. Our 
revisions to this rule are intended to recognize the advent of 
electronic health information technology and to accommodate and support 
adoption of Office of the National Coordinator for Health Information 
Technology (ONC) certified health IT and interoperable standards. We 
believe that the use of such technology can effectively and efficiently 
help facilities and other providers improve internal care delivery 
practices, support the exchange of important information across care 
team members (including patients and caregivers) during transitions of 
care, and enable reporting of electronically specified clinical quality 
measures (eCQMs). For more information, we direct stakeholders to the 
ONC guidance for EHR technology developers serving providers ineligible 
for the Medicare and Medicaid EHR Incentive Programs titled 
``Certification Guidance for EHR Technology Developers Serving Health 
Care Providers Ineligible for Medicare and Medicaid EHR Incentive 
Payments.'' (http://www.healthit.gov/sites/default/files/generalcertexchangeguidance_final_9-9-13.pdf).
    In addition, we encourage facilities to engage in healthcare 
coalitions in their area in effort to identify local best practices and 
potential examples that may assist them in developing communication 
plans that include a procedure for sharing information and medical 
documentation, when necessary, with other healthcare facilities to 
ensure continuity of care.
    Comment: A few commenters discussed the requirements for 
communication plans as set out in the most recent NFPA[supreg] 99-2012 
guidelines. Citing the NFPA[supreg] 99-2012 requirements for 
communication plans, the commenters noted that CMS' proposed 
communication plan requirements are too general by comparison. The 
commenters stated that this generalization would make it harder to 
verify that a facility's plan meets the emergency preparedness 
requirements and would make the verification of adherence to these 
requirements tedious and subjective. Furthermore, the commenters stated 
that the proposal mimics the current standard in the NFPA[supreg] 99-
2012, and may cause misinterpretation and conflict as the regulations 
change over time.
    A commenter stated that some key communication planning items are 
not included in the proposed rule and are better described in the 
standard NFPA[supreg] 99, ``Health Care Facilities Code, 2012 
edition.''
    Response: We appreciate the commenters' feedback about the 
NFPA[supreg] 99-2012 edition. We issued a final rule on May 4, 2016 
entitled ``Medicare and Medicaid Programs; Fire Safety Requirements for 
Certain Health Care Facilities'' (81 FR 26871), to adopt the 2012 
editions of NFPA[supreg] 101, ``Life Safety Code,'' and NFPA[supreg] 
99, ``Health Care Facilities Code.'' We refer readers to that final 
rule for a discussion of these requirements.
    We do not believe that we have been overly prescriptive in our 
communication plan requirements. Facilities are afforded the 
flexibility to include more detailed and stringent communication plan 
policies in their emergency preparedness plan, as long as they meet the 
minimum requirements described here.
    Comment: A commenter recommended that CMS explicitly include social 
media in the communications plan requirements. The commenter noted that 
social media has recently proven to be an essential tool for 
communication during disasters.
    Response: We appreciate the commenter's feedback. While we 
acknowledge the importance of other types of electronic communication 
and encourage facilities to utilize technology when developing a well-
organized communication plan, which may include communication through 
social media, the regulations list the minimum requirements for a 
provider's

[[Page 63887]]

communication plan. We have not prescribed specific communication plans 
within our regulations and have instead allowed hospitals the 
flexibility to formulate and maintain their own communication plans. We 
would expect facilities to choose appropriate ways to communicate with 
patients or the community as a whole.
    Comment: A commenter recommended that CMS encourage the integration 
of the hospital in the community Joint Information Center, and focus on 
not only the logistics and infrastructure of communication, but the 
actual management of messages and act of communicating.
    Response: We encourage hospitals to develop an effective 
communication plan that contains contact information for local 
emergency preparedness staff and to also have a primary and alternate 
means for communicating with local emergency management agencies. A 
hospital's communication plan, for example, may have specific protocols 
for communicating with a community emergency operations center or joint 
information center, and if the hospital so chooses, the plan can 
contain procedures on how to formulate, manage, and deliver messages. 
As previously stated, the hospital can exceed the minimum standards 
described here.
    Comment: A few commenters requested clarification on the definition 
of the term ``geographic area'', as used in the requirement for the 
backup of electronic information to be stored within and outside of the 
geographic area where the hospital is located.
    Another commenter stated that it is unclear how a facility could 
demonstrate that any backup system would be sufficiently 
``geographically remote'' from the region and stated that CMS should 
clearly define the expectations of this section. The commenter also 
noted that an expectation that facilities establish data farms in 
extremely remote areas of service was excluded from the ICR burden 
calculations.
    The commenters also expressed concern about the language in the 
proposed rule which stated that ``electronic information would be 
backed up both within and outside the geographic area where the 
hospital was located'' and questioned what exactly constitutes enough 
of a geographic separation to meet the intent of the proposed language.
    Response: We clarify that we are not requiring facilities to 
utilize EHRs or electronic systems that would require external backup, 
off-site storage facilities, or data farms. In meeting the requirement 
that a hospital have a method for sharing information and medical 
documentation for patients under the hospital's care, facilities may 
choose to store or back up electronic information within and outside 
the geographic area if they determine that this is the best option for 
their facility to maintain their ability to provide information that 
can ensure continuity of patient care during a disaster. Facilities may 
find this strategy useful during an emergency if the facility loses 
power or needs to be evacuated. However, although we believe that it is 
a best practice to have an alternate storage location for medical 
documentation, we are not mandating that facilities store information 
within and outside the geographic area where the hospital is located. 
We encourage facilities to consider all options that are available to 
them to protect their medical documentation to ensure continuity of 
care should an emergency or disaster occur.
    Comment: A commenter recommended that CMS require facilities to 
address recovery of operations planning in emergency and communications 
plans.
    Response: We agree that it is important for hospitals and other 
providers and suppliers to consider recovery of operations while 
planning for an emergency. However, we note that the scope and focus of 
the emergency preparedness requirements in this regulation are on 
continuity of operations during and immediately after an emergency. 
Hospitals and other providers and suppliers may choose, as a best 
practice, to incorporate recovery of operations in their emergency 
plans but we note that this is not a requirement that needs to be met 
in order to be in compliance with these conditions of participation. We 
refer readers to the resources noted in this final rule on recovery of 
operations.
    Comment: A commenter noted that when large scale events occur, 
public communication systems are overburdened and ineffective. 
Furthermore, the commenter noted that although hospitals will have 
alternate means to communicate through technology such as HAM radio, 
800 megahertz (MHz)/ultrahigh frequency (UHF) radio, satellite systems, 
and Government Emergency Telecommunications Service (GETS), these 
technologies will not be readily available to the persons that the 
hospital may be trying to reach. The commenter recommended that CMS 
focus on the hospital establishing processes to readily communicate 
with staff, care providers, suppliers, and family.
    Response: We understand the commenter's concerns about failures in 
public communication systems and we agree that hospitals should include 
processes that would allow for communication with staff, care 
providers, families, and others who may not have alternative forms of 
technology such as HAM and satellite systems. However, hospitals should 
be as well prepared as possible ahead of an emergency or disaster as 
they attempt to mitigate any potential system failures. We believe that 
our proposal to require that hospitals develop and maintain a 
communication plan that includes a means for communicating with 
hospital staff, and with federal, state, tribal, regional, and local 
emergency management entities, appropriately helps to prepare hospitals 
to communicate with the appropriate emergency management officials 
during an emergency or disaster. We encourage hospitals to consider all 
types of alternate communication systems and to develop a communication 
plan that includes procedures on how these alternate communication 
plans are used, and who uses them. Hospitals may seek information on 
the National Communication System (NCS), which offers a wide range of 
National Security and Emergency Preparedness communications services, 
the Government Emergency Telecommunications Services (GETS), the 
Telecommunications Service Priority (TSP) Program, Wireless Priority 
Service (WPS), and Shared Resources (SHARES) High Frequency Radio 
Program at http://www.hhs.gov/ocio/ea/National%20Communication%20System/ (click on ``services'').
    Comment: A commenter stated that state, regional and local 
emergency operations have required the ``Chain of Command'' process. 
The commenter notes that facilities should have the flexibility to 
adhere to the state/regional Chain of Command and that clarification is 
needed to define the scope of the expectation of the proposed rule.
    Response: As previously stated, Sec.  482.15(c) states that 
hospitals must develop and maintain an emergency preparedness 
communication plan that complies with both federal and state law. We 
are not prescribing, nor are we mandating, that hospitals abide by a 
certain ``Chain of Command'' process. As long as hospitals are 
complying with federal and state law, hospitals are given the 
flexibility in these rules to comply with a ``Chain of Command'' 
process that is utilized at their state or local level. We do encourage 
hospitals to understand National Incident

[[Page 63888]]

Management System (NIMS) which provides a common emergency response 
structure and suggested communications processes that will better 
support and enable integration with local, tribal, regional, state and 
federal response operations. We would also expect hospitals that choose 
to comply with a ``Chain of Command'' process would include such 
procedures in their communication plan.
    Comment: A commenter recommended that CMS include language in Sec.  
482.15(c)(6) requiring the disclosure of patient information to state 
and local emergency management agencies.
    Response: We believe that hospitals should have a means of 
providing information, as permitted under the HIPAA Privacy Rule, 45 
CFR 164.510, in the event of an evacuation and that a hospital should 
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). However, we do not believe that it is appropriate to 
include in these regulations a mandatory requirement that hospitals 
specifically disclose patient information to state and local health 
department and emergency management agencies. Hospitals may release 
patient information during an evacuation or emergency disaster, in 
compliance with federal and state laws.
    Comment: A commenter recommended that CMS include the phrase ``and 
in accordance with state law'' in Sec.  482.15(c)(6).
    Response: We disagree with the commenter that an additional phrase 
``and in accordance with state law'' should be included in Sec.  
482.15(c)(6). We believe that language at Sec.  482.15(c), which states 
that the hospital must develop and maintain an emergency preparedness 
communication plan that complies with both federal and state law, 
sufficiently addresses concerns about hospital compliance with state 
laws.
    Comment: A commenter recommended that CMS consider including non-
healthcare facilities in the communication plan, such as child care 
programs and schools, where children with disabilities and other access 
and functional needs may be sheltering in place.
    Response: We do not believe that it is appropriate to require 
hospitals to include other providers of services, such as child care 
programs and schools, in their communication plan in these conditions 
of participation. However, we have allowed facilities the flexibility 
and the discretion to include such providers in their communication 
plans if deemed appropriate for that facility and patient population.
    Comment: A commenter stated that communications planning should 
include equipment interoperability, redundancy, communications, and 
cyber security provisions. The commenter also stated that the primary 
and alternate communication systems for hospitals should include 
interoperability coordination, planning and testing with interdependent 
healthcare systems, their supporting critical infrastructure systems, 
and critical supply chains.
    Response: We agree with the commenter that hospitals should 
consider security, equipment interoperability, and redundancy in their 
emergency preparedness plan. We also agree with the statement that 
hospitals should plan for and test interoperability of their 
communication systems during drills and exercises. However, we are 
allowing facilities flexibility in how they formulate and 
operationalize the requirements of the communication plan. We have not 
included specific requirements on cyber security and redundancy. 
However, we encourage facilities to assess whether their specific 
facility can benefit from such plans.
    Comment: A few commenters requested that CMS provide clarification 
on which federal laws are referenced in the proposed rule in regards to 
the proposed communication plan. The commenters wanted to ensure that 
facilities are aware of, and comply with, all applicable federal 
regulations. A commenter expressed concern that, without knowing the 
federal statutes referenced it would be difficult for hospitals to 
assess whether compliance would be burdensome. A commenter stated that 
clarifying this statement would assist facilities to determine the real 
cost of compliance.
    Response: As with all CoPs, we expect facilities to adhere to 
additional federal and state laws that are applicable and necessary to 
provide quality healthcare. For example, some states might have more 
stringent requirements for their healthcare facilities and personnel 
and we would expect the facilities to comply with those requirements. 
Our CoPs do not preclude facilities from establishing requirements that 
are more stringent.
    We encourage facilities to determine what federal, state, and local 
laws apply to their specific facility's locations and develop plans 
that comply with these federal, state, and local emergency preparedness 
requirements.
    Comment: A commenter stated that while most hospitals meet the 
requirements in the proposed communication plan, the onus should be 
with the state and not the hospital to determine authorized levels of 
interoperability with all healthcare partners.
    Response: We understand the commenter's concerns about the 
potential burden on hospitals. However, we believe that hospitals have 
the ability to maintain an emergency preparedness communication plan 
while working in conjunction with the federal, state, tribal, regional 
or local emergency preparedness staff. We expect that hospitals will be 
able to communicate and coordinate with other healthcare facilities in 
order to protect patient health and safety during an emergency or 
disaster event. We continue to support hospitals and other facilities 
engaging in healthcare coalitions in their area for assistance 
broadening awareness and collaboration as well as in identifying best 
practices that can assist them to effectively meet this requirement.
    Comment: A commenter stated that annual review requirements are a 
dated approach to ensuring that policies are kept up-to-date. The 
commenter recommended that CMS eliminate the annual review requirements 
and tie the review and revision to the testing process and periodic 
risk assessment.
    Response: We disagree with the commenter's statement that annual 
review requirements are dated. We believe that hospitals are best 
prepared to act appropriately and swiftly during an emergency or 
disaster event with an updated communication plan. Updating the 
hospital's communication plan, at least annually will account for 
changes in staff that have occurred during the year at the hospital and 
at the federal, state, tribal, regional or local level. In addition, 
hospitals can update their communication plans at any time to 
incorporate the most recent best practices and lessons learned.
    We note that this standard includes the minimum requirements for 
reviewing and updating a hospital's emergency preparedness 
communication plan. Hospitals can review and update their communication 
plan more frequently than annually if they choose to do so. Currently, 
many hospitals frequently update their contact list to account for 
staffing changes. Therefore, we continue to believe that hospitals 
should review and update their communication and emergency preparedness 
plan at least annually.
    Comment: A commenter expressed support for the proposed 
communication plan for hospitals but stated that an annual update of 
staff contact information is not frequent

[[Page 63889]]

enough. The commenter recommended that CMS modify this standard to 
require that staff information be maintained more often than annually, 
such as quarterly or semi-annually. The commenter notes that within 1 
year, key staff and individual responsibilities that are needed during 
an emergency can change.
    Another commenter recommended that facilities reevaluate and update 
their emergency and communication plan within 180 days of a specific 
emergency event.
    Response: We thank the commenters for their suggestion. We agree 
that staff information at hospitals changes frequently and note that, 
as a best practice, hospitals may choose to consider updating their 
communication plan more frequently than annually. However, we are 
requiring that hospitals update their communication plan at least 
annually, which allows for hospitals to update their emergency contact 
list quarterly, semi-annually or more frequently if they choose to do 
so and still maintain compliance with the requirements of this 
standard. We encourage hospitals to assess whether it is appropriate to 
update their contact lists annually or more frequently than annually.
    In regards to the recommendation that facilities reevaluate and 
update their emergency and communication plan within 180 days of a 
specific emergency event, we note that the emergency preparedness CoPs 
require that hospitals and other providers and suppliers review and 
update their plans at least annually at a minimum. We are also 
requiring, at Sec.  482.15(d)(2)(iv), that hospitals 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. Facilities can choose to review and update 
their plans more frequently than annually at their own discretion.
    After consideration of the public comments we received, we are 
finalizing our proposal, with the following modifications:
     Revising Sec.  482.15(c) by adding the term ``local'' to 
this and parallel provisions throughout the rule to clarify that 
hospitals must develop and maintain an emergency preparedness 
communication plan that also complies with local laws.
     Revising Sec.  482.15(c)(4) by replacing the term 
``ensure'' with ``maintain.''
     Revising Sec.  482.15(c)(5) to clarify that hospitals must 
develop a means, in the event of an evacuation, to release patient 
information, as permitted under 45 CFR 164.510(b)(1)(ii).
4. Training and Testing (Sec.  482.15(d))
    We proposed at Sec.  482.15(d) that a hospital develop and maintain 
an emergency preparedness training and testing program. We proposed to 
require the hospital to review and update the training and testing 
program at least annually.
    We stated that a well-organized, effective training program must 
include providing initial training in emergency preparedness policies 
and procedures. We proposed 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. In addition, we proposed that hospitals provide training 
on emergency procedures at least annually and ensure that staff 
demonstrate competency in these procedures.
    Regarding testing, we proposed at Sec.  482.15(d)(2), to require 
hospitals to conduct drills and exercises to test their emergency 
plans. We proposed at Sec.  482.15(d)(2)(i) to require hospitals to 
participate in a community mock disaster drill at least annually. If a 
community mock disaster drill is not available, we proposed that 
hospitals should conduct individual, facility-based mock disaster 
drills at least annually. However, we proposed at Sec.  
482.15(d)(2)(ii) that if a hospital experiences an actual natural or 
man-made emergency that requires 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 proposed at Sec.  482.15(d)(2)(iii) to require hospitals to 
conduct a paper-based tabletop exercise at least annually. We indicated 
that 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. We proposed to 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.
    We proposed 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.
    We received many comments on our proposed changes to require a 
hospital to develop and maintain an emergency preparedness training and 
testing program.
    Comment: In general, most commenters supported our proposal to 
require hospitals to develop an emergency preparedness training and 
testing program. We received a few general comments about the 
requirement. A commenter stated that training and testing would 
heighten provider awareness with regard to the facilities' limitations 
and ultimately ameliorate some of the negative effects of a disaster on 
continuity of care through quicker decision making. A few commenters 
expressed concerns about the financial burden that the development of 
training and testing programs would impose on their facilities. Some 
agreed that state and local governments may be able to provide training 
resources for some rural and smaller hospitals and facilities; however, 
some commenters pointed out that many states and local governments are 
facing considerable staffing and budget cuts, limiting their resources. 
In addition, a few commenters provided suggestions for how we could 
improve the discussion of our proposed requirement within the preamble 
section of the proposed rule.
    Response: We thank the commenters for their support and feedback. 
We agree that overall emergency preparedness planning will have a 
positive impact on facilities, suppliers, and the populations that they 
serve. We recognize the time and financial impact that the development 
of training and testing programs will impose on facilities, but believe 
that the benefits of heightened awareness, improved processes, and 
increased safety and preparedness will ultimately outweigh the burden.
    Comment: Many commenters expressed concerns about the varying 
levels of emergency preparedness experience of hospitals as well as 
other provider and supplier types. Commenters stated that some 
providers, hospitals in particular, may have a trained disaster 
response or planning person on staff. These commenters wanted to know 
how we will take this into consideration when surveying providers and 
suppliers on this training and testing requirement.
    Response: We believe that this final rule establishes core 
components of an emergency preparedness program that align to national 
emergency preparedness standards and can be used not only for 
hospitals, but across provider and supplier types, while tailoring 
requirements for individual provider and supplier types to their 
specific needs and circumstances, as well as the needs of their 
patients,

[[Page 63890]]

residents, clients, and participants. We proposed individual 
requirements for each provider and supplier type that will be surveyed 
at the individual facility level. As with the standard surveying 
process, each provider and supplier type will be individually surveyed 
for their specific training and testing requirements, rather than in 
comparison to the capabilities of other healthcare settings affected by 
this regulation. In addition, as discussed earlier, we are finalizing 
our proposal for an implementation date that is one-year after the 
effective date of this final rule. This implementation date will allow 
providers who may not be experienced in emergency preparedness 
planning, time to access resources and develop plans that best meet 
their needs. We are not requiring that any facility have a designated 
staff member responsible for emergency preparedness. However the 
facility may choose to establish such a position.
    Comment: A few commenters recommended that we specifically require 
that the training and testing program be developed consistent with the 
principles of the Homeland Security Exercise and Evaluation Program 
(HSEEP). A commenter believed that our proposed requirement is not 
specific enough and should lay out exactly what our expectations are 
for a successful training program and what exactly is required. Another 
commenter pointed out that, while we referenced the principles of HSEEP 
in the preamble, we did not require such principles in our regulations. 
A commenter suggested that we require all healthcare facilities to 
receive training in an incident command system.
    Response: We appreciate the recommendations. The requirements we 
establish are the minimum health and safety standards that facilities 
must meet; however, a provider or supplier may choose to set higher 
standards for its facility. In the proposed rule, we provided 
facilities with resources and examples to help them begin developing a 
training and testing program. We do not believe that we should limit 
the principles/guidelines that a facility may want to utilize when 
developing its program.
    Comment: A commenter supported our proposal for the development of 
an emergency preparedness training program, but suggested that 
hospitals and all providers and suppliers include first responders in 
all aspects of their training program. The commenter stated that the 
inclusion of first responders would help to ensure consistency, 
allowing both groups to do their jobs in a more productive and safer 
manner, ultimately improving communications across the board in the 
event of an emergency.
    Response: We agree that first responders are an essential part of 
the emergency management community and are relied upon heavily during a 
man-made or natural disaster. However, we do not have the statutory 
authority to regulate first responders and emergency management 
personnel. In an effort to bolster communication and collaboration, we 
proposed to require that providers and suppliers include in their 
emergency plan a process for ensuring cooperation and collaboration 
with local, tribal, regional, state, and federal health department and 
emergency preparedness officials' efforts. This would include 
documentation of efforts to contact such officials and, when 
applicable, their participation in collaborative and cooperative 
planning efforts. We also encourage providers and suppliers to engage 
and collaborate with their local healthcare coalition, which commonly 
includes the health department, emergency management, first responders, 
and other emergency preparedness professionals.
    Comment: A commenter suggested that the requirement for a training 
and testing program specify that drills and exercises must address 
varying emergencies supporting the proposed all-hazards approach to 
planning. The commenter explained that this would include flooding in a 
portion of a building due to a water line rupture as well as flooding 
that requires evacuation of patients. Another commenter suggested that 
the training program should be competency-based. The commenter believed 
that competencies help connect training and testing, in essence 
providing a common denominator and language at the facility 
preparedness level. The commenters also stated that the disaster 
medicine and public health community has long recognized the importance 
of competencies, as evidenced by the multiple competency sets developed 
for disaster health.
    Response: While not explicitly stated, we would assume that a 
hospital's training materials and testing exercises would be reflective 
of the risk assessment that is required as part of their emergency 
plan, utilizing an all-hazards approach. In order to accurately assess 
its plan, a hospital would need to have training and exercises that 
address realistic threats based on their risk assessment, otherwise the 
training and testing program would not be effective. The purpose of the 
training and testing program is to demonstrate the effectiveness of the 
hospital's emergency plan and to use the results of drills and 
exercises to improve the hospital's plan. We would also expect that a 
hospital would want to provide insightful and meaningful training, and 
would therefore tailor its training materials to the audience receiving 
the instruction. A hospital may always choose to establish internal 
facility policies that go beyond the minimum health and safety 
standards that we are finalizing.
    Comment: A few commenters pointed out that many healthcare 
facilities are actively educating their staff on emergencies specific 
to their environments and conducting preparedness exercises. Some 
commenters suggested that annual training would only be appropriate for 
staff members who may take on positions in an emergency, but would be 
irrelevant to a large portion of the system's staff.
    A few comments stated that our proposal for annual staff training 
is inappropriate, redundant in many situations, and a waste of scarce 
healthcare resources. Some commenters recommended that we only require 
annual training and exercises for those providers that would be 
instrumental in a disaster and require less frequent training and 
exercises for those providers that would not be expected to be 
operational during a disaster.
    Response: As evidenced by every new disaster, and by the GAO and 
OIG reports that we discussed in the proposed rule (See 78 FR 79088), 
we believe that there is substantial evidence that provider and 
supplier staff need more training in emergency practices and 
procedures. Initial and annual staff training promotes consistent staff 
behavior and increases the knowledge of staff roles and 
responsibilities during a disaster. To offset some of the financial 
impact that training may impose on facilities, we have allowed 
facilities the flexibility to determine the level of training that any 
staff member may need. A provider could decide to base this 
determination on the staff member's involvement or expected role during 
a disaster. In addition, since staff members may be expected to act 
outside of their usual role during a disaster, providers could also 
decide to equally train staff on varying functions during a disaster. 
In this final rule we have revised our proposal to allow for large 
health systems to develop an integrated emergency preparedness program 
for all of their facilities, which would include an integrated training 
program. Therefore, to offset some of the financial burden, facilities 
that are part of a large

[[Page 63891]]

health system may opt to participate in their health system's universal 
training program. However, the training at each separately certified 
facility must address the individual needs for such facility and 
maintain individual training records in order to demonstrate 
compliance.
    Comment: A few commenters requested that we clarify what annual 
training would involve and define the minimum requirements of training 
needed to meet this annual training requirement.
    Response: We are giving facilities the flexibility to determine the 
focus of their annual training. Because we are requiring that the 
emergency plan and policies and procedures be updated at least 
annually, staff would need to be trained on any updates to the 
emergency plan and policies and procedures. For instance, acceptable 
annual training could include training staff on new evacuation 
procedures that were identified in the facility's risk assessment and 
added to the emergency plan within the last year.
    Comment: A commenter did not support our proposed requirement for 
annual training and stated that a demonstration of skill requires some 
method of physical validation. The commenter also stated that annual 
training would be overly burdensome for providers. Another commenter 
suggested that instead of requiring annual training, we should require 
annual validation of knowledge through written testing, demonstration, 
or real-world response based on plans and policies. A commenter 
expressed support for the intent of the annual training requirement, 
but encouraged CMS to provide more detail and information related to 
specific levels of training for individual healthcare workers within a 
provider or supplier organization. Also, some commenters requested 
clarification on how staff would demonstrate their knowledge of 
emergency preparedness.
    Response: We thank the commenters for their feedback. We did not 
specify the content of a facility's annual training. The purpose of the 
requirement is to ensure that facilities are continually educating 
their staff on their emergency preparedness procedures and discussing 
how to implement such procedures during an emergency. We believe that 
it is up to a provider or supplier to determine what level of training 
is required of their staff based on their individual emergency plans 
and policies and procedures. We note that we also proposed to require 
at Sec.  482.15(d)(1)(iv) that hospitals ensure that staff can 
demonstrate knowledge of their facility's emergency procedures. We 
believe that this requirement, in addition to the annual training 
requirement, requires facilities to ensure that staff is continuously 
being updated and educated on a facility's emergency procedures and 
encourages facilities to ensure that the annual trainings are 
informative and insightful, so that staff can demonstrate knowledge of 
the procedures. We would also expect that the results of the knowledge 
check should produce information that can be used to update the 
emergency plan and any future training.
    Comment: Several commenters agreed that training of staff and 
volunteers is a significant aspect of emergency planning and pointed 
out that, in a disaster, many members of the hospital staff will 
continue to perform the same job they do every day. Commenters pointed 
out that most hospitals already provide basic awareness level training 
to staff as well as more comprehensive training for employees who are 
assigned a leadership or management role in the hospital's incident 
command system during an emergency.
    Several commenters requested that we clarify who exactly we are 
referring to in paragraph Sec.  482.15(d)(1)(i), which states that 
individuals providing services under arrangement must receive initial 
training in emergency preparedness policies and procedures. Several 
commenters requested that we provide examples to eliminate any 
confusion about the use of the phrase. Other commenters stated that 
they believed that CMS was referring to groups of physicians, other 
clinicians, and others who provide services essential for adequate care 
of patients and maintenance of operation of the facilities, but whose 
relationship with the hospital is by contract rather than through 
employment or voluntary status. The commenters pointed out that there 
may be others with whom a hospital would have an arrangement for the 
provision of services, but these may be services that would not be 
essential during the course of a disaster. For example, the commenters 
explained that hospitals often have arrangements for servicing of 
office equipment, provision of staff training and education, grounds 
keeping, and so forth. The commenters stated that they do not believe 
it was our intent for all personnel covered by these arrangements to be 
trained for emergency preparedness, but would appreciate some 
clarification.
    Several commenters recommended that we allow hospitals the 
flexibility to identify outsourced services that would be essential 
during a disaster and allow the hospital to identify which of these 
contracted individuals should receive training. Furthermore, a 
commenter posed a set of specific scenarios for us to consider, 
including whether the employees of a contracted food service, or a 
contracted plumber or electrician would need to have emergency 
preparedness training before they are able to work in the hospital. 
Similarly, this commenter believed that the language, as proposed, 
needed to be clarified.
    In addition, a commenter requested that we further define what we 
mean by ``volunteers'' who would need to be trained. The commenter 
stated that the term was vague and questioned whether every volunteer 
would need training, and if so, what level of training. The commenter 
also inquired about a requested time frame for volunteers to complete 
training and how often volunteers would be required to be retrained. 
The commenter pointed out that volunteers are under no obligation to 
report for duty and cannot be relied upon to perform specified 
responsibilities during a disaster.
    Finally, a commenter requested that we include a definition of 
``staff'' in our proposal to require staff training, since many 
inpatient hospital-based specialists, such as hospitalists or 
neonatologists, now provide much of the inpatient medical care. The 
commenter also suggested that we require hospitals to identify 
individuals on staff and under contract that would need basic training, 
as well as staff that would likely manage an emergency event. The 
commenter suggested that we require hospitals to have a documented 
training plan for individuals with key responsibilities. The commenter 
also stated that hospitals should not be required to train all staff, 
contractors, and volunteers given that the costs associated with such 
training would far exceed the benefit in times of scarce resources.
    Response: We appreciate all of the detailed feedback that we 
received from commenters on this requirement. The term ``staff'' refers 
to all individuals that are employed directly by a facility. The phrase 
``individuals providing services under arrangement'' means services 
furnished under arrangement that are subject to a written contract 
conforming with the requirements specified in section 1861(w) of the 
Act. According to our regulations, governing boards, or a legally 
responsible individual, ensures that a facility's policies and 
procedures are carried out in such a manner as to comply with 
applicable federal, state and local laws. We believe that anyone, 
including volunteers, providing services

[[Page 63892]]

in a facility should be at least annually trained on the facility's 
emergency preparedness procedures. As past disasters have shown, 
emergency situations or disasters can be either expected or unexpected. 
Therefore, training should be made available to everyone associated 
with the facility, and it is up to the facility to determine the level 
to which any specific individual should be trained. One way this could 
be determined is by that individual's involvement or expected role 
during an emergency. We stated at Sec.  482.15(d)(1)(i) that training 
should be provided consistent with facility staff's expected roles. To 
mitigate costs it may be beneficial for facilities to take this 
approach when establishing their training programs. In addition, as we 
state elsewhere in this preamble, we encourage facilities to 
participate in healthcare coalitions in their area. Depending on their 
duties during an emergency, a facility may determine that documented 
external training is sufficient to meet the facility's requirements.
    Comment: Many commenters supported the requirement for 
participation in a community drill/exercise and stated that it would 
better prepare both facility staff and patients regarding procedures in 
an actual emergency. However, a few commenters requested clarification 
of the requirement. Specifically, some commenters requested that we 
clarify what we meant by ``community,'' while another commenter 
encouraged CMS to allow organizations to define their community as they 
saw fit rather than based on geographical locations. A commenter 
questioned if standard state-required emergency drills would meet the 
requirement of a community disaster drill. The commenter noted that in 
their state, all facilities are required to participate in a statewide 
tornado drill that evaluates the facility and staff on their ability to 
recognize the threat alert and respond to the alert in accordance with 
their emergency plan. Another commenter requested that we specify how 
intensive an exercise would need to be in order to meet the new 
requirements.
    Response: We understand that many disasters, such as floods, can 
involve a wide geographic area. In addition, we also recognize that 
many hospitals and various providers operate as part of a large health 
system. However, we would still expect a hospital or other healthcare 
facility to consider its physical location and the individuals who 
reside in their area when conducting their community involved testing 
exercises. We did not define ``community'', to afford providers the 
flexibility to develop disaster drills and exercises that are realistic 
and reflect their risk assessments. However, the term could mean 
entities within a state or multi-state region. The goal of the 
provision is to ensure that healthcare providers collaborate with other 
entities within a given community to promote an integrated response. In 
the proposed rule, we indicated that we expected hospitals and other 
providers to participate in healthcare coalitions in their area for 
additional 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, as well as the local health and emergency 
management agencies, during emergency preparedness planning and 
response activities. Conducting integrated planning with state and 
local entities could identify potential gaps in state and local 
capabilities that can then be addressed in advance of an emergency. 
Regional planning coalitions (multi-state coalitions) meet and carry 
out exercises on a regular basis to test protocols for state-to-state 
mutual aid. The members of the coalitions are often able to test 
incident command and control procedures and processes for sharing of 
assets that promote medical surge capacity.
    Comment: Several commenters indicated that the term ``mock'' 
disaster drill is not a common term in emergency exercise vocabulary. 
Some recommended that we use the Homeland Security Exercise and 
Evaluation Program vocabulary, ``disaster drill exercise.'' Another 
commenter suggested that we use the preferred term of ``functional'' or 
``full-scale exercise.'' Commenters believed that these terms are 
clearer in regard to the expectations for hospitals and other 
providers.
    Response: We appreciate the suggestions and agree that the term 
could be revised to more appropriately reflect the intention of the 
requirement. In contrast to an instructor led tabletop exercise 
utilizing discussion, the requirement for participation in a community 
disaster drill exercise is meant to require facilities to simulate an 
anticipated response to an emergency involving their actual operations 
and the community. We are aware that there are several current terms 
used to describe types of exercises and understand how the use of the 
term ``mock disaster drill'' may leave room for confusion. However, we 
note that industry terms evolve and change, so there is a need to 
ensure that the terms in our regulations are broad and inclusive, with 
a ``plain language'' meaning to the extent possible. In this final 
rule, we are revising our proposal by replacing the term ``community 
mock disaster drill'' with ``full-scale exercise.'' We believe that 
this term is broad enough to encompass the suggested terms from 
commenters, as well as an accurate description of the intent behind the 
provision.
    Comment: A few commenters requested further clarification as to 
when a facility-based disaster drill could replace a community disaster 
drill. Most of the commenters pointed out that smaller hospitals and 
those providers outside of the hospital may not have close ties to 
emergency responders or community agencies that organize drills. 
Another commenter wanted to know what requirements would be placed on 
state and local governments to include all provider types in their 
disaster drill planning.
    Response: We would expect that a facility-based disaster drill 
would meet the requirement for a community disaster drill if a 
community disaster drill were not readily accessible. For example, a 
rural provider located in a remote location might have limited ability 
to participate in a community disaster drill and would conduct a 
facility-based drill in order to comply with this requirement. The 
intention of this requirement is to not only assess the feasibility of 
a provider's emergency plan through testing, but also to encourage 
providers to become engaged in their community and promote a more 
coordinated response. Therefore, smaller facilities without close ties 
to emergency responders and community agencies are encouraged to reach 
out and gain awareness of the emergency resources within their 
community. We note that CMS does not regulate state and local 
governments' disaster planning activities.
    Comment: Most commenters supported our proposal to exempt providers 
from the community mock drill requirement if the facility had 
experienced a disaster in the past year. A few commenters requested 
clarification on what would be considered activation of a facility's 
plan. The commenter wondered if there would have to be involvement of 
local emergency management or whether the activation could be made by 
the facility itself.
    Response: In the proposed rule we stated that for the purpose of 
the proposed regulation, ``emergency'' or ``disaster'' can be defined 
as an event

[[Page 63893]]

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 HHS, or the President of the United States 
(see 78 FR 79084). In addition, as noted earlier in the general 
comments section of this final rule, an emergency event could also be 
an event that affects the facility internally as well as the overall 
target population or the community at large. While allowing for the 
exemption of the community disaster drill requirement when an actual 
emergency event is experienced, we also proposed to require that 
facilities maintain documentation of all exercises and emergency 
events. To that extent, upon survey, a facility would need to show that 
an emergency event had occurred and be able to demonstrate how its 
emergency plan was put into action as a result of the emergency event.
    Comment: Many commenters requested clarification of our proposal to 
require one tabletop exercise annually. Commenters stated that we did 
not provide a clear expectation of what tabletop exercise would meet 
our requirements. Commenters also recommended that we note that 
tabletop exercises could be computer-simulated and that we should not 
limit the requirement to paper-based tabletop exercises. A commenter 
noted that we were silent regarding who could serve as a facilitator 
for the tabletop exercise and questioned if a facilitator could be a 
staff member.
    Response: In the proposed rule, we indicated that 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. We believe that this would also include 
the use of computer-simulated exercises. We also suggested that 
providers and suppliers consider using, among other resources, the 
tabletop exercise toolkit developed by the New York City Department of 
Health and Mental Hygiene's Bureau of Communicable Diseases (September 
2005, found at: http://www.nyc.gov/html/doh/downloads/pdf/bhpp/bhpp-train-hospital-toolkit-01.pdf or the RAND Corporation's 2006 tabletop 
exercise technical report (http://www.rand.org/pubs/technical_reports/2006/RAND_TR319.pdf) to help them comply with this requirement. We were 
purposely silent on who could facilitate a tabletop exercise and 
believe that decision should be left to the discretion of the facility.
    Comment: A commenter suggested that we require the tabletop 
exercises to focus on decompression of existing staffed beds (that is, 
how to move less critically ill patients out of the facility), 
identification of alternate space within a facility or adjacent campus 
buildings, and sheltering in place. The commenter also pointed out that 
many accrediting organizations require medical surge exercises, which 
could be combined in a decompression/surge scenario to incorporate 
issues that could occur in a real life event and might be a better 
focus for facility exercises.
    Response: We appreciate the commenter's suggestion. We understand 
that depending on varying factors, such as provider type, size of 
facility, complexity of offered services, and location, facilities will 
have differing risks and needs. Therefore, we believe that facilities 
should have the flexibility to determine the focus of their exercises 
based upon their individual risk assessment, emergency plan, and 
policies and procedures. We note that, without more information about 
the specific medical surge exercise, in order to assess compliance, 
facilities would need to be able to demonstrate to surveyors how the 
medical surge exercise appropriately tests the facility's emergency 
preparedness plan.
    Comment: Multiple commenters expressed their concern regarding our 
intent to require both a community mock disaster drill and a tabletop 
exercise every year and questioned the need for both. We received 
conflicting comments about the accessibility and burden of 
participating in a community mock disaster drill. While a few 
commenters stated that a community mock drill would be burdensome and 
require significant planning and time, other commenters stated that 
most organizations have several opportunities to participate in some 
type of integrated preparedness training exercise within their 
community every year. We also received conflicting comments about the 
effectiveness of tabletop exercises. A few commenters stated that 
tabletop exercises do not adequately determine the functionality of an 
emergency plan and can reduce a facility's level of preparedness. 
Another commenter stated that tabletop exercises are an efficient way 
to test policies that are currently in the plan and ensure that staff 
is knowledgeable about current operating procedures. Another commenter 
stated that tabletop exercises add value, but that a full-scale 
disaster drill is considered a best practice. A commenter stated that 
the requirement for a tabletop exercise is impractical for smaller 
providers and suggested that we base the necessity of the requirement 
on facility size.
    Many commenters stated that most accrediting organizations and 
emergency response organizations require that providers test their 
emergency plans at least twice annually through fully operational 
exercises; these organizations do not accept a tabletop exercise to 
satisfy this requirement. These commenters recommended that we require 
two disaster drills annually and eliminate the requirement for a 
tabletop exercise. Furthermore, the commenters recommended that one of 
the drills be a community drill. Commenters also suggested that we 
exempt those facilities that participate in two annual disaster drills 
from the tabletop exercise requirement. A commenter suggested that we 
require a community mock disaster drill 1 year and a tabletop exercise 
the next year, rather than both in the same year. A commenter stated 
that conducting a disaster drill would require a good amount of 
planning and interruption of clinical services, therefore reducing this 
requirement to every other year would reduce the burden on the 
facility. Another commenter requested that we allow providers the 
flexibility to determine the type of drill or exercise needed to test 
their plan in accordance with their internal policies and procedures.
    Response: We continue to believe that both a disaster drill and a 
tabletop exercise are effective in emergency preparedness planning. We 
understand that while beneficial, drills and exercises have financial 
implications that can be burdensome for some provider and supplier 
types. Many commenters observed that most hospitals are currently 
conducting drills and exercises, so any additional financial impact 
would be minimal. Therefore, in this final rule we are revising our 
proposed provision at Sec.  482.15(d)(2) to require facilities to 
conduct one full-scale exercise and an additional exercise of their 
choice, which could be a second full-scale exercise or a tabletop 
exercise. We note that the full-scale exercise must be community-based 
unless a community exercise is not available. Facilities may opt to 
conduct more exercises, as needed, to improve their emergency plans and 
prepare their staff and patients and are encouraged to include 
community-based partners in all of their additional exercises where 
appropriate. We believe that this revision will give facilities the 
ability to determine which

[[Page 63894]]

exercise is most beneficial to them as they consider their specific 
needs.
    Comment: A commenter suggested that CMS require providers of all 
types to participate at least once annually in instructional programs, 
presentations, or discussion forums delivered by state health 
departments.
    Response: We do not believe that it is appropriate to compel 
providers to attend instructional programs, presentations, or 
discussion forums delivered by state health agencies. However, as noted 
in Sec.  482.15, hospitals must comply with all applicable federal and 
state emergency preparedness requirements. Therefore, if a hospital is 
located in a state that mandates that hospitals participate in 
emergency preparedness instructional programs, the hospital must comply 
with that state's laws. In addition, if hospitals' management 
determines such programs to be beneficial to such hospitals in 
development or maintenance of their emergency preparedness plans, such 
hospitals have the discretion, under these requirements, to attend such 
programs as they see fit, or they can incorporate such requirements 
into their training programs. It is not a requirement of these CoPs 
that hospitals attend programs overseen by state health departments.
    Comment: A commenter suggested that we require completion of after-
action reports (AARs) and Improvement Plans (IP) following the 
completion of drills, exercises, and real events. The commenter also 
suggested that these documents be made available for surveyors. In 
addition, the commenter indicated that subsequent exercises and 
retesting should also be required to demonstrate that improvements were 
successfully made.
    Response: We proposed to require at Sec.  482.15(d)(2)(iv) that 
hospitals analyze their response to, and maintain documentation of, all 
drills, tabletop exercises, and emergency events, and revise the 
hospital's emergency plan, as needed. Demonstrating the thorough 
completion of an AAR or IP would meet this requirement; however, we are 
not requiring completion of specific reports, in order to give 
facilities some flexibility in this area. In addition, as an example, 
we provided a link to the CMS developed Health Care Provider AAR/IP 
template in the proposed rule, which is a voluntary and user-friendly 
tool for healthcare providers to use to document their performance 
during emergency planning exercises and real emergency events, to 
inform recommendations for improvements for future performance. We 
indicated that, while we do not mandate the use of this template, 
thorough completion of the template would comply with our requirements 
for provider exercise documentation. Lastly, we believe our proposed 
requirement at Sec.  482.15(d)(2)(i) and (iii) that a disaster drill 
and a tabletop exercise be conducted annually addresses the commenter's 
concern about subsequent exercises and retesting since a facility can 
test any problems it identifies in an upcoming testing exercise.
    Comment: We received a few comments on our proposed requirement for 
hospitals to analyze the hospital's response to, and maintain 
documentation for, all drills, tabletop exercises, and emergency 
events, and revise the hospital's emergency plan, as needed. A 
commenter questioned how long after a training the documentation of 
such training would need to be retained. Another commenter recommended 
that, if a hospital were to experience two or more actual emergencies 
and performs an after-action review of its emergency plan, it should be 
exempt from this requirement.
    Response: We believe that this requirement is necessary to ensure 
that hospitals are benefiting from the lessons learned through testing 
their plans and revising them as necessary, based on these lessons. We 
believe that, if a hospital experiences an actual emergency and 
develops an after-action review, it would be practical for the hospital 
to use this as an opportunity to revise and update their plan 
accordingly. In addition, we would expect a facility to maintain 
training documentation to demonstrate that it has met the training 
requirements. We note that hospitals are required at Sec.  482.15(d) to 
update and review their training and testing program at least annually.
    In summary, after consideration of the public comments, we are 
finalizing our proposal for hospitals to develop and maintain an 
emergency preparedness training and testing program as proposed, with 
the following exceptions:
     Revising Sec.  482.15(d) by adding that each hospital's 
training and testing program must be based on the hospital's emergency 
plan, risk assessment, policies and procedures, and communication plan.
     Revising Sec.  482.15(d)(1)(iv) by replacing the phrase 
``Ensure that staff can demonstrate'' with the phrase ``Demonstrate 
staff knowledge.''
     Revising Sec.  482.15(d)(2) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  482.15(d)(2) to allow a hospital to choose 
the type of exercise it will conduct to meet the second annual testing 
requirement.
5. Emergency Fuel and Generator Testing (Sec.  482.15(e))
    We proposed at Sec.  482.15(e)(1)(i) that hospitals store emergency 
fuel and associated equipment and systems as required by the 2000 
edition of the Life Safety Code (LSC) (NFPA[supreg]101) of the 
NFPA[supreg]. We note that CMS recently issued a final rule on May 4, 
2016 entitled ``Medicare and Medicaid Programs; Fire Safety 
Requirements for Certain Health Care Facilities'' (81 FR 26872), to 
adopt the NFPA[supreg] 2012 edition of the LSC and the ``Health Care 
Facilities Code.'' The current LSC states that a hospital's alternate 
source of power (for example, a 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 healthcare facility. Also, the LSC states that the rooms, 
shelters, or separate buildings housing the emergency power supply must 
be located to minimize the possible damage resulting from disasters 
such as storms, floods, earthquakes, tornadoes, hurricanes, vandalism, 
sabotage and other material and equipment failures.
    In addition to the emergency power system inspection and testing 
requirements found in NFPA[supreg] 99, ``Health Care Facilities Code,'' 
NFPA[supreg] 101,``Life Safety Code,'' and NFPA[supreg] 110, ``Standard 
for Emergency and Standby Power Systems,'' we proposed 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.
    We also proposed emergency and standby power requirements for CAHs 
and LTC facilities. As such, we requested information on this proposal, 
in particular on how we might better estimate costs in light of the 
existing LSC requirements, as well as other state and federal 
requirements.
    Comment: We received a large number of comments from individual 
hospitals as well as national and state organizations that expressed 
concern with the proposed requirement for hospitals, CAHs and LTC 
facilities to test their generators. The commenters recommended that we 
continue to refer to the current NFPA[supreg] standards for generator 
testing, along with manufacturers' recommendations. Many commenters 
stated that there was not enough empirical data to support the

[[Page 63895]]

proposed additional testing requirements. They further stated that 
there is no evidence that additional annual testing would result in 
more reliable generators. A commenter stated that a survey of hospitals 
affected by Hurricane Sandy did not indicate that increased testing 
would prevent generator failure during an actual disaster (Flannery, 
Johnathan, ASHE Advocacy Report 2013, pages 34-37) (``ASHE Report''). 
Other commenters stated that hospitals already test generators monthly 
as well as a 4 hour test every 3 years and, in their opinion, this 
testing schedule is sufficient. Some commenters stated that mandating 
additional testing would further burden already strained budgets 
because many healthcare facilities have more than one generator. They 
stated that the additional testing would cause unnecessary wear and 
tear on the equipment. Also, complying with the requirement for 
additional testing in certain geographical locations, such as 
California, could increase air pollution and the potential for some 
facilities to be fined by the EPA for emitting additional carcinogens 
in the air. Another commenter raised concerns that this increase in 
operational time may require additional guidance or permit validation 
from the Environmental Protection Agency (EPA) due to the increase in 
emissions.
    Response: We appreciate the commenters concerns on this issue. As 
we discussed in the proposed rule, the purpose of the proposed change 
in the testing requirement was to minimize the issue of inoperative 
equipment in the event of a major disaster, as occurred with Hurricane 
Sandy. The September 2014 report of the Office of Inspector General 
(OIG) entitled, ``Hospital Emergency Preparedness and Response During 
Hurricane Sandy'' (OIG, OEI-06-13-00260, September 2014) stated that 89 
percent of hospitals reported experiencing critical challenges during 
Sandy, ``such as electrical and communication failures, to community 
collaboration issues over resources, such as fuel, transportation, 
hospital beds, and public shelters.'' According to a survey conducted 
by The American Society for Healthcare Engineering (ASHE) of its member 
facilities affected by Hurricane Sandy (ASHE Report pages 34-37), 35 
percent of the survey respondents reported that they were without power 
for a period of time that ranged from 30 minutes to over 150 hours. 
However, ASHE's survey concluded that there is no indication that 
equipment failure could have been anticipated by increasing the 
frequency of generator testing.
    We also appreciate the commenters that pointed out the logistical 
and budgetary challenges for the healthcare facilities that would be 
affected by this rule. After carefully considering all of the comments 
we received and reviewing reports on Hurricane Sandy and Hurricane 
Katrina (Live Science, ``Why power is So Tricky for Hospital During 
Hurricanes'', Rachael Rettner, November 1, 2012 see http://www.livescience.com/24489-hospital-power-outages-hurricane-sandy.html), 
we believe that there are not sufficient data to assume that additional 
testing would ensure that generators would withstand all disasters, 
regardless of the amount of testing conducted prior to an actual 
disaster. Therefore, we have decided against finalizing the proposed 
requirement for additional generator testing at this time. We would 
expect facilities that have generators to continue to test their 
equipment based on NFPA[supreg] codes in current general use (2012 
NFPA[supreg] 99, 2010 NFPA[supreg] 110 and 2012 NFPA[supreg] 101) and 
manufacturer requirements. Accordingly, we have revised Sec.  
482.15(e)(1) and (2) by removing the additional testing requirements 
and adding a new paragraph (h) which incorporates by reference the 2012 
version the NFPA[supreg] 99, 2010 NFPA[supreg] 110 and 2012 
NFPA[supreg] 101. As discussed in this final rule, we are also removing 
the additional generator testing requirements for CAHs and LTC 
facilities.
    Comment: Several commenters stated that CMS standards regarding the 
location and maintenance of generators should be aligned as much as 
possible with existing standards, laws and regulations, to avoid 
conflict and confusion; and that the standards should be evaluated and 
updated periodically to reflect new knowledge and advances in 
technology. Many commenters agree with the proposed rule that would 
require a hospital's generator to be located in accordance with the 
requirements found in NFPA[supreg] 99, NFPA[supreg] 101, and 
NFPA[supreg] 110. Furthermore, they commented that CMS should be 
aligned with NFPA[supreg] in how it implements these standards. They 
stated that requirements already exist through NFPA[supreg] and local 
building codes, and that facilities currently comply with all 
applicable requirements. They also stated that the requirement for all 
emergency generators to be located in an area that is free from 
possible flooding should only apply to new installations, construction 
or renovation of existing structures. While no empirical data were 
provided, commenters claimed that relocation of existing equipment and 
systems would be cost-prohibitive.
    Response: We appreciate the support of the commenters that agreed 
with the proposed requirement that generators be located in accordance 
with the requirements found in NFPA[supreg] 99, NFPA[supreg] 101, and 
NFPA[supreg] 110. These codes require hospitals that build new 
structures, renovate existing structures, or install new generators to 
place backup generators in a location that would be free from possible 
flooding and destruction. As such, the CMS requirements are aligned 
with the Life Safety Code (NFPA[supreg] 101), (which has been generally 
incorporated into CMS regulations) which cross-references 2012 
NFPA[supreg] 99 and NFPA[supreg] 110, at Sec.  482.15.
    Comment: A few commenters recommended that CMS consider bringing 
any additional generator requirement to the NFPA[supreg] Technical 
Committees that maintain standards for emergency and stand-by power.
    Response: The NFPA[supreg] is a private, nonprofit organization 
dedicated to reducing loss of life due to fire and other disasters. We 
have incorporated some of NFPA's codes, by reference, in our 
regulations. The statutory basis for incorporating NFPA's Codes for our 
providers and suppliers is the Secretary's general authority to 
stipulate such additional regulations for each type of Medicare and 
Medicaid participating facility as may be necessary to protect the 
health and safety of patients. In addition, CMS has discretionary 
authority to develop and set forth health and safety regulations that 
govern providers and suppliers that participate in the Medicare and 
Medicaid programs.
    Comment: A few commenters stated that facilities should be required 
to have a backup plan that addresses the loss of power in a way that 
would allow them to continue operations without outside electricity. 
The commenter stated that this could be addressed a number of ways, 
including by diverting patients to a nearby facility within a 
reasonable commuting distance that has sufficient power for the 
facility to treat patients.
    Response: We agree with the commenters. We would encourage 
facilities to develop an emergency plan that explores the best case 
scenarios to ensure optimum protection for patients and residents 
during an emergency. There are times when we would expect a facility to 
shelter in place and other times when it might be more feasible to 
evacuate. However, a hospital, or other inpatient provider, is likely 
to have inpatients at the beginning of a disaster,

[[Page 63896]]

even when evacuation is planned. Therefore, the facility must be able 
to provide continued operations until all its patients have been 
evacuated and its operations cease.
    Comment: A few commenters stated that alternate sources of energy 
to meet all regulatory requirements are currently available through 
emergency generators. They stated that it is neither practical nor 
prudent to require an emergency generator at all healthcare facilities, 
some of which simply close or relocate during a power loss.
    Response: We proposed that the requirements for an emergency 
generator and onsite fuel source to power the emergency generator would 
apply only to hospitals, CAHs and LTC facilities. We did not include 
other providers/suppliers discussed in the proposed rule.
    Comment: Several commenters opposed requiring facilities that 
maintain an onsite fuel supply to maintain a quantity of fuel capable 
of sustaining emergency power for the duration of the emergency or 
until likely resupply. The commenter pointed out that this approach 
does not consider the situation in which a hospital or LTC facility 
would evacuate or close during a prolonged emergency. A few commenters 
questioned how long a hospital should provide or maintain alternate 
sources of energy. Another commenter stated that what a facility 
anticipates it will need during ``an emergency'' does not necessarily 
match its in[hyphen]house generator's capacity. A facility gap analysis 
would define anticipated need per planned for emergency, and a 
facility's in[hyphen]house unit may be ample for some scenarios and not 
for others. A gap analysis may identify times when evacuation is 
recommended versus other scenarios when in-house capacity is ample to 
sustain operations.
    Response: We appreciate all of the comments on this proposal. We 
realize that it would be difficult, if not impractical in certain 
circumstances, for a facility to have a fuel supply that would be 
sufficient for the duration of all disasters because the magnitude of 
the disaster might require facilities to evacuate patients/residents. 
After a careful evaluation of the comments, we have changed the final 
rule to require a hospital, CAH, or LTC facility to have a plan for how 
it will keep emergency power systems operational during the emergency, 
unless it evacuates.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     Revising Sec.  482.15(e)(2)(i) by removing the requirement 
for an additional 4 hours of generator testing and clarifying that 
facilities must meet the requirements of NFPA[supreg] 99 2012 edition, 
NFPA[supreg] 101 2012 edition, and NFPA[supreg] 110 2010 edition.
     Revising Sec.  482.15(e)(3) by removing the requirement 
that hospitals maintain fuel onsite and clarifying that hospitals must 
have a plan to maintain operations unless the hospital evacuates.
     Adding a new Sec.  482.15(h) to incorporate by reference 
the requirements of NFPA[supreg] 99, NFPA[supreg] 101, and NFPA[supreg] 
110.

D. 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 June 2016, there were 18 Medicare-
certified RNHCIs that were subject to the RNHCI regulations.
    A RNHCI is a facility that is operated under all applicable 
federal, state, and local laws and regulations, which provides 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 established religious tenets that 
prohibit conventional or unconventional medical care for the treatment 
of the patient and exclusive reliance on religious activity to fulfill 
a patient's total healthcare needs.
    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.
    We proposed to 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 
proposed for hospitals, subject to several exceptions.
    The existing ``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. Existing Sec.  403.742(a)(4) requires that the 
RNHCI have a written disaster plan that addresses loss of water, 
sewage, power and other emergencies. Existing Sec.  403.742(a)(5) 
requires that a RNHCI have facilities for emergency gas and water 
supply. We proposed relocating the pertinent portions of the existing 
requirements at Sec.  403.742(a)(1), (4), and (5) at proposed Sec.  
403.748(a) and (b)(1).
    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 of 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. We proposed at Sec.  403.748(a)(1) to require 
RNHCIs to consider loss of power, water, sewage and waste disposal in 
their risk analysis. At Sec.  403.748(b)(1)(i) for RNHCIs, we proposed 
to remove the terms ``medical and nonmedical'' to reflect typical RNHCI 
practice, since RNHCIs do not provide most medical supplies. At Sec.  
482.15(b)(3), we proposed that hospitals 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. At Sec.  403.748(b)(3), we proposed to 
incorporate this hospital requirement for RNHCIs but to remove the 
words ``and treatment'' to more accurately reflect that medical care is 
not provided in a RNHCI.
    We proposed at Sec.  403.748(b)(5) to remove the term ``health'' 
from the proposed hospital requirement for ``health care 
documentation'' to reflect the non-medical care provided by RNHCIs.

[[Page 63897]]

    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 
healthcare professionals to address surge needs during an emergency. 
For RNHCIs, we proposed at Sec.  403.748(b)(6) to use the hospital 
provision, but remove the language, ``including the process and role 
for integration of state or federally designated healthcare 
professionals'' since it is not within the religious framework of 
RNHCIs to integrate care issues for their patients with healthcare 
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 proposed substituting ``next of kin, guardian or custodian'' 
for ``patients' physicians'' because RNHCI patients do not have 
physicians.
    Finally, unlike the proposed regulations for hospitals at Sec.  
482.15(c)(4), we proposed at 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 healthcare 
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 removed the term ``other'' and 
``health'' 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 proposed that hospitals 
would be required to conduct drills and exercises to test their 
emergency plan. Because RNHCIs have such a narrow role and provide such 
a unique service in the community, we believe RNHCIs would not 
participate in performing such drills. We proposed that RNHCIs be 
required only to conduct a tabletop exercise annually. Likewise, unlike 
our proposal for hospitals at Sec.  482.15(d)(2)(i), we did not propose 
that the RNHCI conduct a community mock disaster drill at least 
annually or conduct an individual, facility-based mock disaster drill. 
Although we proposed for hospitals at Sec.  482.15(d)(2)(ii) that, if 
the hospital experiences 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 did not propose this for RNHCIs.
    At Sec.  482.15(d)(2)(iv), we proposed 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)(ii), for RNHCIs, we proposed to remove reference to 
drills.
    Currently, at Sec.  403.724(a), we require that an election be made 
by the Medicare beneficiary or his or her legal representative and that 
the election be documented in 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 or 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 proposed that such election documentation be 
shared with other care providers to preserve continuity of care during 
a disaster or emergency.
    We did not receive any comments that specifically addressed the 
proposed rule as it related to RNHCIs. However, after consideration of 
the general comments we received on the proposed rule, as discussed in 
the hospital section (section II.C. of this final rule), we are 
finalizing the proposed emergency preparedness requirements for RNHCIs 
with the following modifications in response to general comments made 
with respect to all facilities:
     Revising the introductory text of Sec.  403.748 by adding 
the term ``local'' to clarify that RNHCIs must also comply with local 
emergency preparedness requirements.
     Revising Sec.  403.748(a)(4) by deleting the term 
``ensuring'' and replacing the term ``ensure'' with ``maintain.''
     Revising Sec.  403.748(b)(2) to remove the requirement for 
RNHCIs to track staff and patients after an emergency and clarifying 
that in the event that staff and patients are relocated during an 
emergency, the RNHCI must document the specific name and location of 
the receiving facility or other location for sheltered patients and on-
duty staff who leave the facility during an emergency.
     Revising Sec.  403.748(b)(5)(iii) and (b)(7) to remove the 
term ``ensure.''
     Revising Sec.  403.748(c) by adding the term ``local'' to 
clarify that the RNHCI must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.
     Revising Sec.  403.748(c)(5) to clarify that RNHCIs must 
develop a means, in the event of an evacuation, to release patient 
information, as permitted under 45 CFR 164.510(b)(1)(ii).
     Revising Sec.  403.748(d) by adding that each RNHCI's 
training and testing program must be based on the RNHCI's emergency 
plan, risk assessment, policies and procedures, and communication plan.
     Revising Sec.  403.748(d)(1)(iv) by replacing the phrase 
``ensure that staff can demonstrate'' with the phrase ``demonstrate 
staff.''

E. Emergency Preparedness Regulations for Ambulatory Surgical Centers 
(ASCs) (Sec.  416.54)

    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 are scheduled, elective, 
procedures for non-life-threatening conditions that can be safely 
performed in a Medicare-certified ASC setting.
    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.
    As of June 2016 there were 5,485 Medicare certified ASCs in the 
U.S. The ASC Conditions for Coverage (CfCs) at 42 CFR part 416, subpart 
C, are the health and safety standards a facility must meet to obtain 
Medicare certification. Existing Sec.  416.41(c) 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

[[Page 63898]]

patients, staff and others in the facility; (2) coordinate the plan 
with state and local authorities; and (3) conduct drills at least 
annually, complete a written evaluation of each drill, and promptly 
implement any correction to the plan. Since the proposed requirements 
are similar to and would be redundant with existing rules, we proposed 
to remove existing Sec.  416.41(c). Existing Sec.  416.41(c)(1) would 
be incorporated into proposed Sec.  416.54(a), (a)(1), (2), and (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 (iv).
    We proposed to require ASCs to meet most of the same proposed 
emergency preparedness requirements as those we proposed for hospitals, 
with two exceptions. At Sec.  416.54(c)(7), we proposed that ASCs be 
required to have policies and procedures that include a means of 
providing information about the ASCs' needs and their 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 did not propose that these 
facilities provide information regarding their occupancy, as we 
proposed for hospitals, since the term ``occupancy'' usually refers to 
occupancy in an inpatient facility. Additionally, we did not propose 
that these facilities provide for subsistence needs of their patients 
and staff.
    Comment: Many commenters commended CMS' efforts to ensure that 
providers are prepared for emergencies. However, these commenters 
disagreed with CMS' proposed emergency preparedness requirements for 
ASCs. The commenters stated that the proposed requirements are too 
burdensome and that the current ASC disaster preparedness requirements 
in Sec.  416.41(c) allow providers the appropriate amount of 
flexibility during an emergency. The commenters stated that ASCs should 
not be subjected to the same emergency preparedness requirements as 
hospitals. Most of these commenters requested that CMS revise the 
proposed emergency preparedness requirements for ASC. Some of these 
commenters recommended that CMS not finalize any of the proposed 
emergency preparedness requirements for ASCs.
    Response: We understand the commenter's concerns and we agree with 
some of the comments that suggested that the emergency preparedness 
requirements for ASC should be modified, and we discuss these 
modifications in this rule. However, we disagree with the commenter's 
statement that emergency preparedness requirements for ASCs are 
burdensome and inflexible. We continue to believe that ASCs should 
develop an emergency preparedness plan that is based on a facility-
based and community-based risk assessment utilizing an all-hazards 
approach. We believe that the emergency preparedness requirements 
finalized in this rule provide ASCs and other providers with the 
flexibility to develop a plan that is tailored to the specific needs of 
an individual ASC. There are several key differences between the 
requirements for ASCs and hospitals, including but not limited to 
subsistence needs requirements and the requirements to implement an 
emergency and standby power system. We have taken into consideration 
the unique characteristics of an ASC and have finalized flexible and 
appropriate emergency preparedness requirements for ASCs.
    Comment: Several commenters agreed with exempting ASCs from the 
requirements to provide occupancy information and subsistence needs for 
staff and patients. The commenters noted that these requirements would 
be inappropriate for the ASC setting since many patients may visit an 
ASC once or twice during an episode of care. However, the commenters 
noted that other emergency preparedness requirements are inappropriate 
for the ASC setting. The commenters expressed concern about the 
requirement that ASCs must develop an emergency preparedness plan that 
includes a process for ensuring cooperation and collaboration with 
local, tribal, regional, state, and federal emergency preparedness 
official's efforts to ensure an integrated response during a disaster 
or emergency situation. The commenters noted that in many instances, 
communities do not include ASCs in their emergency preparedness 
efforts. They recommended that CMS explicitly state that an ASC is in 
compliance with all community-based requirements, as long as the ASC 
has written documentation of its attempts to cooperate and collaborate 
with community organizations, even if the community organizations never 
respond.
    Response: We appreciate the commenter's support. Based on responses 
from several commenters, we are changing the wording of Sec.  416.54(a) 
for this final rule to state that ASCs must include a process for 
maintaining 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. We 
expect that ASCs will document their efforts to contact pertinent 
emergency preparedness officials and, when applicable, document their 
participation in any collaborative and cooperative planning efforts. We 
understand that providers cannot control the actions of other entities 
within their community and we are not expecting providers to hold 
others accountable for their participation or lack of participation in 
community emergency preparedness efforts. However, providers do have 
control over their own efforts and can develop a plan to cooperate and 
collaborate with members of the emergency preparedness community. We 
continue to believe that communication and cooperation with pertinent 
emergency preparedness officials is an important part of a coordinated 
and timely response to an emergency.
    Comment: Several commenters expressed concern about the proposal to 
require that ASCs develop 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. The 
commenters noted that many ASCs offer specific, specialized elective 
procedures and non-emergency services and that the staff that work in 
an ASC do not have experience with trauma surgery and triaging. They 
also noted that, in case of an emergency, ASCs would cancel upcoming 
procedures, stabilize patients already in the facility, transfer 
patients who require a higher level of care, account for all ASC staff 
and volunteers, and either shelter in place current staff and 
volunteers or send them home. The commenters requested that CMS not 
finalize this proposal.
    Response: We agree with the commenters. We understand that most 
ASCs are highly specialized facilities that would not necessarily 
transfer patients to other ASCs during an emergency and, based on this 
understanding of the nature of ASCs, we believe that ASCs should not be 
required to establish arrangements with other ASCs to transfer and 
receive patients during an emergency. Therefore, we are not finalizing 
the proposed requirement at Sec.  416.54(b)(6). During an emergency, if 
a patient requires care that is beyond the capabilities of the ASC, we 
would expect that ASCs would transfer patients to a hospital with which 
the ASC has a written transfer agreement, as required by existing Sec.  
416.41(b), or to the local hospital, that meets the

[[Page 63899]]

requirements of Sec.  416.41(b)(2), where the ASC physicians have 
admitting privileges. ASCs should also consider in, their risk 
assessment, alternative hospitals outside of the area to transfer 
patients to, if the hospital with which the ASC has a written transfer 
agreement or admitting privileges is also affected by the emergency.
    Comment: A commenter stated that the proposed rule was unclear 
about what is expected of ASCs in regards to requirements for alternate 
sources of energy to maintain temperature, emergency lighting, and fire 
detection, extinguishing and alarm systems.
    Response: We did not propose specific temperature, emergency 
lighting, fire detection, extinguishing and alarm systems, or emergency 
and standby power requirements for ASCs. However, ASCs would be 
expected to follow all pertinent federal, state, and local law 
requirements outside of these regulations.
    Comment: A commenter was concerned that ASCs would be required to 
comply with the Emergency Preparedness Checklist: Recommended Tool for 
Effective Health Care Facility Planning, before the final emergency 
preparedness regulations are published. The commenter suggested that 
the current survey process could be used to collect statistically 
significant data regarding the application of the final rule.
    Response: The emergency preparedness checklist that the commenter 
refers to is a recommended checklist for emergency preparedness only. 
We are not requiring ASCs or other providers to comply with the 
recommendations in this checklist. However, ASCs must comply with the 
emergency preparedness requirements finalized in this rule 1 year after 
the final rule is published, as discussed in section II.B. of this 
final rule.
    Comment: We proposed to require ASCs to track their patients and 
staff before and during an emergency. Most commenters questioned why 
some of the outpatient suppliers, such as CORFs and Organizations, were 
being treated differently and not required to track their patients and 
staff during an emergency when their services were vital to their 
patient populations. Commenters indicated that similar to these 
facilities, ASCs also have the flexibility to cancel appointments and 
close in the event of an emergency. Commenters requested that we remove 
this requirement.
    Response: We proposed this requirement for ASCs because we believed 
an ASC should maintain responsibility for their staff and patients, if 
staff and patients were in the facility during the event of an 
emergency. For reasons discussed earlier, we have removed ``after the 
emergency'' from the regulations text for ASCs. We agree that if an 
emergency were to arise, ASCs would have the flexibility to cancel 
appointments and close. However, we also believe that emergencies may 
arise while staff and patients are in the ASC. Therefore, we do not 
believe the requirement should be removed. Instead, we are revising the 
regulations text further to require that if any staff or patients are 
in the ASC during an emergency and transferred elsewhere for continued 
or additional care, the ASC must document the specific name and 
location of the receiving facility or other location for those patients 
and on-duty staff who are relocated during and emergency. We note that 
if the ASC is able to close or cancel appointments, there would be no 
need to track patients or staff.
    Comment: Several commenters expressed concern about whether the 
communication requirement could be interpreted to require the use of 
EHRs in ASCs. They noted that ASCs have not been included in recent 
federal programs that foster the use of healthcare information 
technology. A commenter noted that almost no ASCs are equipped with an 
interoperable EHR system that could communicate with other providers 
and suppliers.
    Response: As finalized, Sec.  416.54(c)(4) requires that facilities 
have a method for sharing information and medical documentation for 
patients under the ASC's care, as necessary, with other healthcare 
facilities to ensure continuity of care. We are not requiring, nor are 
we endorsing, a specific digital storage device or technology for 
sharing information and medical documentation. Furthermore, we are not 
requiring facilities to use EHRs or other methods of electronic storage 
and dissemination. In this regard, we acknowledge that some facilities 
are still using paper based documentation. However, we encourage all 
facilities to investigate effective ways to secure, store, and 
disseminate medical documentation, as permitted by the HIPAA Privacy 
Rule, to ensure continuity of care during an emergency or a disaster.
    Comment: A few commenters stated that the proposed communication 
plan requirements would unnecessarily overburden ASCs. A commenter 
indicated specific concerns about ASCs maintaining contact information 
for other ASCs and stated that since ASCs are not 24-hour care 
facilities and because a transfer to another facility would likely be 
the result of a patient needing a high level of care, it is not 
reasonable for an ASC to have the contact information for other ASCs in 
their communication plan. Furthermore, the commenter noted that it is 
unreasonable for ASCs to have contact information for a list of 
emergency volunteers.
    Other commenters stated that it would be reasonable for an ASC to 
develop a communication plan that would require ASCs to maintain 
contact information for those who work at their facilities and for 
community emergency preparedness staff.
    Response: We disagree with the commenter's suggestion that ASCs 
would not be able to develop a communication plan that would include 
policies to maintain the contact information of the appropriate 
facility and emergency preparedness staff. ASCs are one of the few 
provider and supplier types that already have CfCs for emergency and 
disaster preparedness. They are currently required to maintain a 
written disaster preparedness plan that provides for care of patients 
and staff during an emergency and to coordinate the plan with state and 
local authorities, as appropriate. Therefore, we would expect that 
these ASC facilities would already have contact information for 
emergency management authorities and appropriate staff. We believe 
that, in light of these existing requirements, it is feasible for an 
ASC to continue to maintain these requirements and include written 
documentation for a communication plan.
    However, we do agree with the commenters that it may be 
unreasonable for an ASC to maintain the contact information for other 
ASCs, given the highly specialized nature of care in most ASC 
facilities. The procedures performed in an ASC vary depending on the 
focus of the ASC. Some ASCs specialize solely in eye procedures, while 
other may specialize in orthopedics, plastic surgery, pain treatment, 
dental, podiatric, urological, etc. Therefore, we are not finalizing 
our proposal to require that ASCs maintain the names and contact 
information for other ASCs in the ASC's communication plan.
    Comment: Several commenters addressed the proposal that would 
require ASCs to release patient information as permitted under 45 CFR 
164.510 of the HIPAA Privacy Rule and to have a communication system in 
place capable of generating timely, accurate information that could be 
disseminated, as permitted, to family members and others. The 
commenters

[[Page 63900]]

stated that this proposal is inappropriate for the ASC setting. The 
commenters noted that ASCs should be exempt from this requirement, 
since ASCs do not provide continuous care to patients nor to patients 
who are homebound or receiving services at home.
    Response: We disagree with the commenters' statement that ASCs 
should be exempt from the proposed requirement at Sec.  416.54(c)(6) 
that ASCs establish in their communication plan a means, in the event 
of an evacuation, to release patient information as permitted under 45 
CFR 164.510. While it is true that ASCs do not provide continuous care 
to patients, we believe it is still of utmost importance for ASCs to be 
prepared to disseminate information about a patient's status, should an 
unforeseen emergency occur while the ASC is open and in operation. We 
believe that ASCs are fully capable of establishing an effective 
communication plan that would allow for the release of patient 
information in the event of an evacuation. Also, we believe that ASCs 
should be prepared to disseminate information on patients under the 
ASC's' care to family members during an emergency, as permitted under 
45 CFR 164.510(b)(1)(ii). Therefore, it is important that ASCs have a 
plan in advance of this type of situation that would entail how the ASC 
would coordinate this effort to provide patient information. For 
example, if a patient is undergoing a procedure in an ASC and, due to 
an unforeseen natural disaster, the ASC is forced to evacuate or 
shelter in place, the ASC should have a system in place should they 
need to use or disclose protected health information to notify, or 
assist in the notification of, a family member, a personal 
representative, or another person responsible for the care of the 
patient of the patient's location, general health condition, or death. 
We believe patients would be ill-served, and ASCs would be unprepared, 
if such a situation were to occur without a communication plan that 
establishes means, in the event of an evacuation, to release patient 
information. We note that the requirements of this final rule allow 
ASCs flexibility to construct a communication plan that best serves the 
facility's and their patients' individual circumstances.
    Comment: We received several comments from the ASC community that 
opposed our proposal to require ASCs to participate in a community mock 
disaster drill at least once a year. The majority of the commenters 
noted that ASCs are not included in emergency preparedness efforts of 
their community. A commenter specifically noted that many communities 
do not include ASCs in their emergency preparedness efforts because 
they are primarily outpatient facilities that provide elective surgery, 
and are not designed to accommodate an influx of patients in case of an 
emergency. Another commenter noted that the proposed rule does allow 
for ASCs to conduct a facility-based disaster drill if a community 
drill is not available; however they stated that a drill of any kind 
would likely impose an additional burden on an ASC due to limited 
staff. A commenter suggested that ASCs be allowed to conduct a 
facility-based disaster drill if a community drill is not available or 
if the ASC is not part of a community's emergency preparedness efforts.
    Response: We recognize the existence of a lack of community 
collaboration in some areas as it relates to emergency preparedness, 
which is one of the reasons we are seeking to establish unified 
emergency preparedness standards for all Medicare and Medicaid 
providers and suppliers. As noted earlier, we stated in the proposed 
rule that if a community disaster drill is not available, we would 
require an ASC to conduct an individual facility-based disaster drill. 
We also note that for the second annual testing requirement we are 
revising our testing standards to allow either a community disaster 
drill or a tabletop exercise annually, so an ASC may opt to conduct a 
tabletop exercise over a facility-based drill.
    After consideration of the comments we received on the proposed 
emergency preparedness requirements for ASCs and the general comments 
we received on the proposed rule, as discussed in the hospital section 
(section II.C. of this final rule), we are finalizing the proposed 
emergency preparedness requirements for ASCs with the following 
modifications:
     Revising the introductory text of Sec.  416.54 by adding 
the term ``local'' to clarify that ASCs must also comply with local 
emergency preparedness requirements.
     Revising Sec.  416.54(a)(4) to delete the term 
``ensuring'' and to replace the term ``ensure'' with ``maintain.''
     Revising Sec.  416.54(b)(1) to remove the requirement for 
ASCs to track all staff and patients after an emergency and requiring 
that if any on-duty staff or patients are in the ASC during an 
emergency and transferred or relocated, the ASC must document the 
specific name and location of the receiving facility or other location.
     Revising Sec.  416.54(b)(4)(iii) by replacing the phrase 
``ensures records are secure'' with the phrase ``secures and maintains 
the availability of records.''
     Removing Sec.  416.54(b)(6) that requires that ASCs 
develop 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, and renumbering 
paragraph (b)(7) as paragraph (b)(6).
     Revising Sec.  416.54(c) by adding the term ``local'' to 
clarify that the ASC must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.
     Revising Sec.  416.54(c)(1)(iv) to remove the requirement 
that ASCs include the names and contact information for ``Other ASCs'' 
in the communication plan.
     Revising Sec.  416.54(c)(5) to clarify that ASCs must 
develop a means, in the event of an evacuation, to release patient 
information, as permitted under 45 CFR 164.510(b)(1)(ii).
     Revising Sec.  416.54(d) by adding that each ASC's 
training and testing program must be based on the ASC's emergency plan, 
risk assessment, policies and procedures, and communication plan.
     Revising Sec.  416.54(d)(1)(iv) by replacing the phrase 
``ensure that staff can'' with the phrase ``demonstrate staff.''
     Revising Sec.  416.54(d)(2)(i) by removing the requirement 
for ASCs to participate in a community-based disaster drill.
     Revising Sec.  416.54(d)(2) to allow an ASC to choose the 
type of exercise they will conduct to meet the second annual testing 
requirement.
     Adding Sec.  416.54(e) to allow a separately certified ASC 
within a healthcare system to elect to be a part of the healthcare 
system's emergency preparedness program.

F. 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 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.

[[Page 63901]]

    Hospices provide 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.
    As of June 2016, there were 412 inpatient hospice facilities 
nationally. Under the existing hospice CoPs, 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.''
    For hospices, we proposed to retain existing regulations at Sec.  
418.110(c)(1)(i), which state that a hospice must address real or 
potential threats to the health and safety of the patients, other 
persons, and property. However, we proposed to incorporate the existing 
requirements at Sec.  418.110(c)(1)(ii) into proposed Sec.  
418.113(a)(2) and (d)(1). We proposed to require at Sec.  418.113(a)(2) 
that the hospice's emergency preparedness plan include contingencies 
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 proposed to require at Sec.  418.113(d)(1)(iv) 
that the hospice 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. We proposed that Sec.  418.110(c)(1)(ii) and the designation 
for paragraph (i) of Sec.  418.110(c)(1) be removed. Otherwise, the 
proposed emergency preparedness requirements for hospice providers were 
very similar to those for hospitals.
    In the proposed rule, we stated that despite the key differences 
between hospitals and hospices, we believed the hospital emergency 
preparedness requirements, with some reorganization and revision are 
appropriate for hospice providers. Thus, our discussion focused on the 
requirements as they differed 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 proposed to organize the requirements for the hospice provider's 
policies and procedures differently from the proposed policies and 
procedures for hospitals. Specifically, we proposed to group 
requirements that apply to all hospice providers at Sec.  418.113(b)(1) 
through (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 proposed 
at Sec.  418.113(b)(2) to require all hospices, regardless of whether 
they operate their own inpatient facilities, to have policies and 
procedures to inform state and local officials about hospice patients 
in need of evacuation from their respective residences at any time due 
to an emergency situation based on the patient's 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 recognized that many frail 
hospice patients may be unable to evacuate from their homes without 
assistance during an emergency. This additional proposed requirement 
recognized the responsibility of the hospice to support the safety of 
its patients that reside in the community.
    We note that the proposed requirements for communication at Sec.  
418.113(c) were 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 proposed to limit to inpatients the 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. The proposed requirements for 
training and testing at Sec.  418.113(d) were the same as those 
proposed for hospitals.
    Comment: A commenter stated that it was unreasonable for home based 
hospices to be aligned with or have similar emergency preparedness 
requirements as hospitals. Another commenter requested that we exempt 
inpatient hospice facilities from meeting the same emergency standards 
as hospitals.
    Response: We understand that residential facilities function much 
differently than hospitals; however we do not believe that we solely 
aligned the hospice requirements with hospitals. As stated in the 
proposed rule, we proposed to develop core components of emergency 
preparedness that could be used across provider and supplier types, 
while tailoring requirements for individual provider and supplier types 
to their specific needs and circumstances, as well as the needs of 
their patients. Specifically for hospice providers, we believe that we 
gave much consideration to whether the hospice was home based or an 
inpatient hospice. For example, we organized the hospice policies and 
procedures requirements based on those that apply to all hospice 
providers and those that apply to only hospice inpatient care 
facilities. Given the terminally ill status of hospice patients, we 
continue to believe that in an emergency situation they may be as or 
more vulnerable than their hospital counterparts. This could 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 of the hospital-based 
clinician. We continue to believe that the hospital emergency 
requirement, with some reorganization and revision as proposed, is 
appropriate for all hospice providers. In addition, we note that 
existing hospice regulations at Sec.  418.110(c)(1) already require 
inpatient hospice facilities to have a written disaster preparedness 
plan. Therefore, we do not agree that an exemption for inpatient or 
outpatient hospice facilities is appropriate.
    Comment: A commenter noted that inpatient hospice facilities are 
often small in size and free-standing rather than integrated into 
larger healthcare facilities. The commenter requested that we provide 
flexibility in our requirements based on the size of a facility. In 
addition, the commenter indicated that smaller inpatient hospices do 
not have institutional kitchens and often contract for the provision of 
food. The commenter questioned whether it is acceptable to provide 
readymade meals for patients and staff for sheltering in place and for 
what period of time will hospices be expected to prepare to provide 
subsistence needs.
    Response: We appreciate the commenter's feedback. Where feasible, 
we did not propose overly prescriptive requirements for any of the 
providers and suppliers, regardless of size. We note that we are only 
requiring facilities to have policies and procedures to address the 
provision of subsistence in the event of an emergency. This could 
include establishing a relationship with a non-profit that provides 
meals during disasters. All hospices have the flexibility to determine 
and manage the types, amounts, and needed preparation for providing 
subsistence needs based on their own facility risk assessments. We 
believe that allowing each

[[Page 63902]]

individual hospice the flexibility to identify the subsistence needs 
that would be required during an emergency is the most effective way to 
address subsistence needs without imposing undue burden.
    Comment: A commenter recommended that the executive team of each 
individual hospice should determine which staff should participate in 
the creation of their emergency preparedness plans, process, and tools.
    Response: We thank the commenter for their suggestion. We did not 
indicate who must develop the emergency preparedness plans. All 
providers and suppliers have the flexibility to determine the 
appropriate staff that should be involved in the development of their 
entire emergency preparedness program.
    Comment: A commenter supported our requirement for hospices to 
develop procedures to inform State and local officials about hospice 
patients in need of evacuation from their residences due to an 
emergency situation. However, the commenter indicated that for smaller 
hospice providers, developing and maintaining a current list of 
patients in need of evacuation assistance, along with the type of 
assistance required, will be a time-consuming manual effort. The 
commenter requested that we provide as much flexibility to this 
requirement as possible.
    Response: We appreciate the commenter's support and feedback. We 
disagree with the statement that it would be overly burdensome for 
hospices to maintain a current list of patients and their needs of 
assistance. We also note that we did not limit the way in which 
hospices have to collect, maintain, or share this information. As a 
best practice, most hospices, regardless of size, maintain an up-to-
date list of their current patients for organizational purposes and to 
maintain operations. In addition, we believe that it is current 
practice for staff to make daily assessments of the needs and 
capabilities of their hospice patients. We would also assume that the 
smaller the hospice, the smaller the number of patients they would need 
to assess and document. We continue to believe that it is critically 
important that hospices have a way to share this information with State 
and local officials.
    Comment: Specific to hospices, commenters were unclear about what 
it would mean for a hospice to track patients from setting to setting 
during an emergency. For those home-based hospices, commenters noted 
that unlike an institutional setting, hospice patients reside in the 
community and their private residence with access to travel freely. 
Commenters supported the intent of the requirement, but requested that 
CMS revise this requirement taking into consideration the complexity of 
tracking patients receiving home-based care.
    Response: We understand that we were not clear in our proposal 
about our intentions as to how hospice providers could meet this 
requirement. In addition, after reviewing the issues raised by 
commenters, we agree that further consideration should be given to 
variations between inpatient hospices and home based hospices. We agree 
that this factor, whether the hospice is inpatient or home based, 
creates a difference in the hospice provider's ability to track 
patients. Therefore, we are removing the requirement for home based 
hospices to track their staff and patients. Similar to the revisions we 
made for HHA, we are replacing the tracking requirement with a 
requirement for home based hospices to have policies and procedures 
that address the follow up procedures the hospice will exercise in the 
event that their services are interrupted during or due to an emergency 
event. In addition, the hospice must inform state and local officials 
of any on-duty staff or patients that they are unable to contact. 
Similar to the revisions we made for hospitals, we are keeping the 
requirement for inpatient hospices to track staff and patients during 
an emergency, but removing the language ``after the emergency'' from 
the regulation text. Instead we are revising the text to clarify that 
in the event that on-duty staff or patients are relocated during an 
emergency, the inpatient hospice must document the specific name and 
location of the receiving facility or other location for on-duty staff 
and patients who leave the facility during the emergency (that is, 
another facility, alternate sheltering location, etc.). We expect that 
for administrative purposes, all hospices already have some mechanism 
in place to keep track of patients and staff contact information. In 
addition, we expect that as a best practice, all hospices will find it 
necessary to communicate and follow up with their patients during or 
after an interruption in their services to close the loop on what 
services are needed and can still be provided. All hospices will have 
the flexibility to determine how best to develop these procedures, 
whether they utilize an electronic communication or some other method. 
We expect that the information would be readily available, accurate, 
and shareable among officials within and across the emergency response 
system, as needed, in the interest of the patient.
    Comment: A hospice provider agreed with the need for a 
communication plan to be included in the emergency plan, but was unsure 
whether this should be addressed in a separate regulation specifically 
addressing communication. Another commenter supported the proposed 
communication plan requirements for hospices and HHAs, and noted the 
importance of communicating information to relevant authorities and 
facilities about the location and condition of vulnerable individuals, 
who may have difficulty evacuating during a disaster or emergency due 
to the severity of their illness.
    Response: We appreciate the commenters' support and we agree with 
the commenters' point about the importance of communicating patient 
information, especially for vulnerable populations. We believe that it 
is important that hospice providers include in their emergency 
preparedness plans a communication plan that is reviewed and updated 
annually. We believe that requirements for a hospice's communication 
plan should be included in these emergency preparedness regulations, 
since we believe that an emergency preparedness plan for facilities is 
not complete without plans for communicating during an emergency or 
disaster.
    Comment: A few hospice providers expressed concern about the 
proposed communication plan for hospices with respect to federal and 
state funding and support.
    A commenter stated that most hospices do not have access to funding 
to purchase communication networks that link to first responders, 
hospitals, and county/regional Incident Command Centers. They stated 
that, aside from land lines and cell phones if they are available, 
communication could be very challenging, if not impossible. Another 
commenter stated that it would take more time, and more federal and 
state support, for hospice providers to meet the proposed requirements.
    Response: We thank the commenters for their feedback. We understand 
the commenters' concerns about means of communication for hospice 
providers and refer readers to various communication planning 
resources, including http://www.hhs.gov/ocio/ea/National%20Communication%20System/ (The National Communication System) 
and those resources referenced in the proposed rule and this final 
rule.
    We expect facilities to develop and maintain policies and 
procedures for patient care and their overall operations.

[[Page 63903]]

The emergency preparedness requirement may increase costs in the short 
term because resources would have to be devoted to the assessment and 
development of an emergency plan that utilizes an all-hazards approach. 
While the proposed requirements could result in some immediate costs to 
a provider or supplier, we believe that developing an emergency 
preparedness program would be beneficial overall to any provider or 
supplier. In addition, we believe that planning for the protection and 
care of patients, clients, residents, and staff during an emergency or 
a disaster is a good business practice.
    Comment: A few commenters expressed their concern about our 
proposal to require hospices to participate in both a community mock 
disaster drill and a paper based tabletop exercise. Mainly, the 
commenters acknowledged the benefits and necessity of participating in 
drills and exercises to determine the effectiveness of an emergency 
plan, but stated that conducting drills and exercises in the hospice 
setting is time consuming and would disrupt and compromise patient 
care.
    Response: We agree that patient care is always the priority; 
however we believe that requiring staff to participate in training once 
a year is reasonable. Since the training will be anticipated, we 
believe that it would be possible for staff to work with their patients 
to adjust their schedules accordingly in order to participate in any 
such training. Emergency preparedness testing and training could be 
consolidated with other hospice training to reduce the impact and 
address staffing limitations. In addition, we believe that our decision 
to change our proposal to allow for either a community disaster drill 
or a tabletop exercise annually for the second annual testing 
requirement will provide hospices with the flexibility to determine 
which testing drill or exercise would be most beneficial to their 
organization, taking into consideration factors such as staff 
limitations and financial cost.
    After consideration of the comments we received on the proposed 
emergency preparedness requirements for hospices, and the general 
comments we received on the proposed rule, as discussed in the hospital 
section (section II.C. of this final rule), we are finalizing the 
proposed emergency preparedness requirements for hospices with the 
following modifications:
     Revising the introductory text of Sec.  418.113 by adding 
the term ``local'' to clarify that hospices must also coordinate with 
local emergency preparedness requirements.
     Revising Sec.  418.113(a)(4) to delete the term 
``ensuring'' and to replace the term ``ensure'' with ``maintain.''
     Revising Sec.  418.113(b)(1) to remove the requirement for 
home-based hospices to track staff and patients.
     Revising 418.113(b)(1) to clarify that in the event that 
there is an interruption in services during or due to an emergency, 
home based hospices must have policies in place for following up with 
on-duty staff and patients to determine services that are still needed. 
In addition, they must inform State and local officials of any on-duty 
staff or patients that they are unable to contact.
     Revising Sec.  418.113(b)(5) to delete the term ``ensure'' 
and to replace it with the term ``maintain.''
     Revising Sec.  418.113(b)(6)(iii)(A) by adding that 
hospices must have policies and procedures that address the need to 
sustain pharmaceuticals during an emergency.
     Revising Sec.  418.113(b)(6) by adding a new paragraph (v) 
to require that inpatient hospices track on-duty staff and patients 
during an emergency, and, in the event staff or patients are relocated, 
inpatient hospices must document the specific name and location of the 
receiving facility or other location to which on-duty staff and 
patients were relocated to during the emergency.
     Revising Sec.  418.113(c) by adding the term ``local'' to 
clarify that the hospice must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.
     Revising Sec.  418.113(c)(5) to clarify that hospices must 
develop a means, in the event of an evacuation, to release patient 
information, as permitted under 45 CFR 164.510(b)(1)(ii).
     Revising Sec.  418.113(d) by adding that each hospice's 
training and testing program must be based on the hospice's emergency 
plan, risk assessment, policies and procedures, and communication plan.
     Revising Sec.  418.113(d)(1)(ii) to replace the phrase 
``Ensure that hospice employees can demonstrate'' to ``Demonstrate 
staff.''
     Revising Sec.  418.113(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  418.113(d)(2) to allow a hospice to choose 
the type of exercise it will conduct to meet the second annual testing 
requirement.
     Adding Sec.  418.113(e) to allow separately certified 
hospices within a healthcare system to elect to be a part of the 
healthcare system's emergency preparedness program.

G. Emergency Preparedness Regulations for 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 CoPs, at Sec. Sec.  
441.150 through 441.182 and Sec. Sec.  483.350 through 483.376 
respectively. As of June 2016, there were 377 PRTFs.
    A PRTF provides inpatient psychiatric services for patients under 
age 21. Under Medicaid, these 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 proposed to require that PRTF facilities 
meet the same requirements we proposed for hospitals. Because these 
facilities vary widely in size, we would expect that their emergency 
preparedness risk assessments, emergency plans, policies and 
procedures, communication plan, and training and testing will vary 
widely as well. However, we believe PRTFs have the capability to comply 
fully with emergency preparedness requirements so that the health and 
safety of its patients are protected in the event of an emergency 
situation or disaster.
    Comment: A commenter questioned if a generator would be required to 
be used as an alternate source of energy.
    Response: Emergency and standby power systems are not a requirement 
for PRTFs. That requirement applies only to hospitals, CAHs and LTC 
facilities. Alternate sources of energy could include, for example, 
propane, gas, and water-generated systems, in addition to other 
resources.

[[Page 63904]]

    Comment: A commenter stated that it would be difficult for PRTFs, 
ICFs/IIDs, and CMHCs to implement a method to share patient information 
and medical documentation with other healthcare facilities to ensure 
continuity of care, since these entities are not uniformly using 
electronic health records. Therefore, the commenter recommended 
flexibility in the implementation of these requirements.
    The commenter also noted that the CMS proposed rule stated that 
PRTFs are not likely to have formal communication plans. However, the 
commenter stated that PRTFs accredited by TJC are subject to Standard 
EM.02.02.01, which requires that the organization include in an 
emergency preparedness plan details on how the facility will 
communicate during emergencies.
    Response: We believe that we have allowed for flexibility in how 
PRTFs develop and maintain their communication plans. However, if the 
commenter is referring to flexibility in when these requirements will 
be implemented, we refer the commenter to the section of this final 
rule that implements an effective date that is 1 year after the 
effective date of this final rule for these emergency preparedness 
requirements for all providers and suppliers.
    In addition, we acknowledge that some PRTFs may already have 
communication plans in place, as required as a condition of TJC 
accreditation. We appreciate the commenter's feedback and note that 
facilities that meet TJC accreditation standards should be well-
equipped to comply with the communication plan requirements established 
in these CoPs.
    Comment: In response to our proposed requirement for a PRTF to 
participate in a community disaster drill, we received one comment 
which stated that PRTFs are often not included in their larger 
community's preparedness plan. The commenter stated that the lack of 
inclusion often occurs despite the willingness and request on the part 
of the PRTF. The commenter recommended that we allow documentation of 
best efforts to be a part of the community disaster drill to meet this 
requirement.
    Response: We recognize the existence of a lack of community 
collaboration in some areas as it relates to emergency preparedness, 
which is one of the reasons why we are seeking to establish unified 
emergency preparedness standards for Medicare and Medicaid providers 
and suppliers. We stated in the proposed rule that if a community 
disaster drill is not available, we would require a PRTF to conduct an 
individual facility-based disaster drill/full-scale exercise. A PRTF is 
expected to document its efforts to participate in a community disaster 
drill; however, the requirement to conduct a facility-based disaster 
drill/full-scale exercise would still need to be met.
    After consideration of the comments we received on the proposed 
emergency preparedness requirements for PRTFs, and the general comments 
we received on the proposed rule in the hospital section (section II.C. 
of this final rule), we are finalizing the proposed emergency 
preparedness requirements for PRTFs with the following modifications:
     Revising the introductory text of Sec.  441.184 by adding 
the term ``local'' to clarify that PRTFs must also comply with local 
emergency preparedness requirements.
     Revising Sec.  441.184(a)(4) to delete the term 
``ensuring'' and to replace the term ``ensure'' with ``maintain.''
     Revising Sec.  441.184(b)(1)(i) by adding that PRTFs must 
have policies and procedures that address the need to sustain 
pharmaceuticals during an emergency.
     Revising Sec.  441.184(b)(2) by clarifying that tracking 
during and after the emergency applies to on-duty staff and sheltered 
residents. We have also revised paragraph (b)(2) to provide that if on-
duty staff and sheltered residents are relocated during the emergency, 
the facility must document the specific name and location of the 
receiving facility or other location.
     Revising Sec.  441.184(b)(5) to change the phrase 
``ensures records are secure and readily available'' to ``secures and 
maintain availability of records.''
     Revising Sec.  441.184(b)(7) to replace the term 
``ensure'' with ``maintain.''
     Revising Sec.  441.184(c) by adding the term ``local'' to 
clarify that the PRTF must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.
     Revising Sec.  441.184(c)(5) to clarify that PRTFs must 
develop a means, in the event of an evacuation, to release patient 
information, as permitted under 45 CFR 164.510(b)(1)(ii).
     Revising Sec.  441.184(d) by adding that each PRTF's 
training and testing program must be based on the PRTF's emergency 
plan, risk assessment, policies and procedures, and communication plan.
     Revising Sec.  441.184(d)(1)(iii) to replace the phrase 
``ensure that staff can demonstrate'' to ``Demonstrate staff 
knowledge.''
     Revising Sec.  441.184(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  441.184(d)(2)(ii) to allow a PRTF to choose 
the type of exercise it will conduct to meet the second annual testing 
requirement.
     Adding Sec.  441.184(e) to allow a separately certified 
PRTF within a healthcare system to elect to be a part of the healthcare 
system's emergency preparedness program.

H. 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 includes the provision of adult day 
healthcare 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 
furnished under contract. A PACE organization provides medical and 
other support services to patients predominantly in a PACE adult day 
care center. As of June 2016, there are 119 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 
proposed 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).
    Currently 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

[[Page 63905]]

and disasters that are likely to threaten the health or safety of the 
patients, staff, or the public. Currently 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 proposed incorporating the language from Sec.  460.72(c)(1) into 
Sec.  460.84(b). Existing Sec.  460.72(c)(2), which defines various 
emergencies, would be incorporated into Sec.  460.84(b) as well. We did 
not add 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'' 
because we proposed that PACE organizations utilize an ``all-hazards'' 
approach at 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 (5) would be removed.
    We proposed that PACE organizations adhere to the same requirements 
for emergency preparedness as hospitals, with three exceptions. We did 
not propose that PACE organizations provide for basic subsistence needs 
of 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 proposed 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 was that we proposed adding at Sec.  
460.84(b)(4) a requirement for a PACE organization to have policies and 
procedures to inform state and local officials at any time about PACE 
patients in need of evacuation from their residences 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.
    Finally, the third difference between the proposed requirements for 
hospitals and the proposed requirements for PACE organizations was 
that, at Sec.  460.84(c)(7), we proposed 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 did not propose requiring these organizations to provide 
information regarding their occupancy, as we proposed for hospitals 
(Sec.  482.15(c)(7)), since the term ``occupancy'' refers to occupancy 
in an inpatient facility.
    Comment: Several commenters, including PACE providers, opposed our 
proposal to require PACE organizations to provide for the subsistence 
needs of staff and participants whether they evacuated or sheltered in 
place during an emergency; while other providers stated that to do so 
would be a proactive measure to provide provisions for even a short 
amount of time. Some providers stated that these provisions should be 
available to this medically vulnerable, at-risk population during an 
emergency or if shelter in place occurred for a period of time.
    Response: We appreciate the variety of responses we received. Based 
on the comments we received suggesting we include this requirement, we 
are now adding a requirement that PACE organizations must have policies 
and procedures in place to address subsistence needs.
    Comment: A commenter wanted us to define the term ``all-hazards'' 
for PACE organizations. Another commenter requested clarification when 
facility-based and community-based assessments are assessed at a ``zero 
risk'', if this would need to be included in their emergency plan.
    Response: The definition of ``all-hazards'' is discussed under the 
requirements for hospitals and this definition applies to all provider 
and supplier types. If there is an assessed zero risk made during the 
facility and community assessments, then there is no need to include 
this in their emergency plan.
    Comment: A few commenters, including a PACE association and PACE 
providers, requested further clarification on the requirement that PACE 
organizations develop and maintain emergency preparedness communication 
plans that provide ``well-coordinated'' participant care both within 
the affected facilities as well as across public health departments and 
emergency systems. The commenters stated that it would be helpful to 
have a defined ``checklist'' by which PACE organizations could 
determine whether or not they are meeting the requirements to be 
considered ``well-coordinated.''
    Response: We recognize the importance of this inquiry and suggest 
that facilities look to the forthcoming interpretive guidelines after 
the publication of this final rule for more information. We also 
continue to encourage facilities to seek guidance from the many 
emergency preparedness resources we have included in the proposed and 
final rules.
    After consideration of the comments we received on the proposed 
emergency preparedness requirements for PACE organizations, and the 
general comments we received on the proposed rule, as discussed in the 
hospital section (section II.C. of this final rule), we are finalizing 
the proposed emergency preparedness requirements for PACEs with the 
following modifications:
     Revising the introductory text of Sec.  460.84 by adding 
the term ``local'' to clarify that PACE organizations must also 
coordinate with local emergency preparedness requirements.
     Revising Sec.  460.84(a)(4) to delete the term 
``ensuring'' and to replace the term ``ensure'' with ``maintain.''
     Adding Sec.  460.84(b)(1) to address subsistence needs, 
and renumbering the rest of the section accordingly.
     Revising Sec.  460.84(b)(2) by clarifying that tracking 
during and after the emergency applies to on-duty staff and sheltered 
participants. We have also revised paragraph (b)(2) to provide that if 
on-duty staff and sheltered participants are relocated during the 
emergency, the facility must document the specific name and location of 
the receiving facility or other location.
     Revising Sec.  460.84(b)(5) to change the phrase ``ensures 
records are secure and readily available'' to ``secures and maintains 
availability of records;'' also revising paragraph (b)(7) to change the 
term ``ensure'' to ``maintain.''
     Revising Sec.  460.84(c) by adding the term ``local'' to 
clarify that the PACE

[[Page 63906]]

organization must develop and maintain an emergency preparedness 
communication plan that also complies with local laws.
     Revising Sec.  460.84(c)(5) to clarify that the PACE 
organization must develop a means, in the event of an evacuation, to 
release patient information, as permitted under 45 CFR 
164.510(b)(1)(ii).
     Revising Sec.  460.84(d) by adding that each PACE 
organization's training and testing program must be based on the PACE 
organization's emergency plan, risk assessment, policies and 
procedures, and communication plan.
     Revising Sec.  460.84(d)(1)(iii) to replace the phrase 
``Ensure that staff can demonstrate knowledge'' to ``Demonstrate staff 
knowledge.''
     Revising Sec.  460.84(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  460.84(d)(2)(ii) to allow a PACE 
organization to choose the type of exercise it will conduct to meet the 
second annual testing requirement.
     Adding Sec.  460.84(e) to allow a separately a certified 
PACE organization within a healthcare system to elect to be a part of 
the healthcare system's emergency preparedness program.

I. Emergency Preparedness Regulations for Transplant Centers (Sec.  
482.78)

    All transplant centers are located within hospitals. Any hospital 
that furnishes organ transplants and other medical and surgical 
specialty services for the care of transplant patients is a transplant 
hospital (42 CFR 482.70). Therefore, transplant centers must meet all 
hospital CoPs at Sec. Sec.  482.1 through 482.57 (as set forth at Sec.  
482.68(b)), and the hospitals in which they are located must meet the 
provisions of Sec.  482.15. The transplant hospital would be 
responsible for the emergency preparedness program for the entire 
hospital as set forth in Sec.  482.15, including the transplant center. 
In addition, unless otherwise specified, heart, heart-lung, intestine, 
kidney, liver, lung, and pancreas transplant centers must meet all 
requirements for transplant centers at Sec. Sec.  482.72 through 
482.104.
    Transplant centers are responsible for providing organ 
transplantation services from the time of the potential transplant 
candidate's initial evaluation through the recipient's post-transplant 
follow-up care. In addition, if a center performs living donor 
transplants, the center is responsible for the care of the living donor 
from the time of the initial evaluation through post-surgical follow-up 
care.
    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 work 
closely with the hospital in which it is located and the designated 
organ procurement organization (OPO) for that donation service area 
(DSA) (unless the hospital has a waiver approved by the Secretary to 
work with another OPO) in preparing for emergencies so that it can 
continue to provide transplantation and transplantation-related 
services to its patients during an emergency.
    We proposed to add a new transplant center CoP at Sec.  482.78, 
``Emergency preparedness.'' Proposed Sec.  482.78(a) would require a 
transplant center to 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. We also proposed 
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 OPO that identifies specific 
responsibilities for the hospital and for the OPO with respect to organ 
recovery and organ allocation. We proposed 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 
included a similar requirement for OPOs at Sec.  486.360(c) in the 
proposed rule. We anticipated that the transplant center, the hospital 
in which it is located, and the designated OPO would collaborate in 
identifying their specific duties and responsibilities during emergency 
situations and include them in the agreement.
    We did not propose 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 did not propose 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. The hospital in which the 
transplant center is located would be required under Sec.  482.15 to 
provide for any transplant patients and living donors that are 
hospitalized during an emergency.
    Comment: Commenters stated that the proposed requirement for 
transplant centers 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 was unnecessary. 
They noted that transplant centers have a long history of cooperating 
with each other during emergencies, such as during Hurricanes Katrina 
and Rita. A commenter noted that they had never heard of any transplant 
center that failed to ensure that its patients received appropriate 
care during an emergency. Many commenters noted that the Organ 
Procurement and Transplantation Network (OPTN) already has emergency 
preparedness requirements and that we should rely on the OPTN and the 
United Network for Organ Sharing (UNOS) to work with transplant centers 
during emergencies. Specifically, OPTN Policy 1.4.A Regional and 
National Emergencies, which was effective on September 1, 2014, states 
that ``[d]uring a regional or national emergency, the OPTN contractor 
will attempt to distribute instructions to all transplant hospitals and 
OPOs that describe the impact and how to proceed with organ allocation, 
distribution, and transplantation'' (accessed at http://optn.transplant.hrsa.gov/ContentDocuments/OPTN_Policies.pdf#nameddest=Policy_01 on February 24, 2015). Additional 
policies instruct transplant centers and OPOs to contact the OPTN 
contractor for instructions when the transportation of organs is either 
not possible or severely impaired (OPTN Policy 1.4.B), and when 
communication through the internet or telephone is not possible (OPTN 
Policies 1.4.C, 1.4.D, and 1.4.E). If any additional emergency 
preparedness requirements are necessary, those requirements should be 
under the auspices of the OPTN and UNOS or coordinated by these 
organizations.
    Response: We agree with the commenters that transplant centers have 
a long history of working well with each other. However, we also 
believe that transplant centers need to be proactive and make at least 
certain basic preparations for emergency situations. The OPTN does have 
emergency preparedness requirements. However,

[[Page 63907]]

those requirements are not comprehensive, and we do not believe they 
are sufficient. For example, those policies cover the transportation of 
organs and communication interruptions between the OPTN contractor and 
transplant centers and OPOs. They do not cover local emergencies or 
even common emergency situations, such as weather-related events in 
which a transplant center may have a disruption in power or in getting 
its staff into the hospital. In addition, including emergency 
preparedness requirements in the transplant CoPs provides us with 
oversight and enforcement authority and imposes the requirements on 
transplant programs that received their designation by virtue of their 
approval for reimbursement for Medicare. The requirements finalized in 
this rule also should not conflict with the OPTN policies on emergency 
preparedness.
    Comment: Some commenters stated that complying with the proposed 
requirements would be overly burdensome. Commenters indicated our 
burden estimates were extremely conservative and that the proposed 
agreements in Sec.  483.78 could require more than 100 hours, 
especially for hospitals with multiple transplant programs, and perhaps 
as many as 200 contracts. In addition, some commenters also indicated 
that the proposed requirements would result in increased financial 
burden to patients and their families.
    Response: We agree with the commenters. In analyzing the comments 
we received for the transplant center requirements, we now believe that 
some of these requirements, especially the proposed requirement for the 
transplant center to have an agreement with another transplant center, 
would likely require more resources than we originally estimated. There 
is also a possibility that there could be some increase in costs to 
patients and their families. Therefore, we are not finalizing these 
requirements as proposed for transplant centers to have agreements with 
other transplant centers or for the transplant center to ensure that 
the agreement between the hospital in which it is located and the OPO 
addresses the hospital and the OPO's duties and responsibilities during 
an emergency in the agreement required by Sec.  486.100, as required in 
proposed Sec.  482.78. Instead, we are finalizing requirements for 
transplant centers, the hospitals in which they are located, and the 
relevant OPOs in developing and maintaining protocols that address the 
duties and responsibilities of each party during an emergency. We 
believe the burden on transplant centers, patients, and their families 
will be less than estimated burden in the proposed rule. See section 
III.I. of this final rule (Collection of Information Requirements, ICRs 
Regarding Condition of Participation: Emergency Preparedness for 
Transplant Centers (Sec.  482.78)) for our revised burden estimate.
    Comment: Many commenters believed that agreements for emergency 
preparedness between transplant centers would be of little value. Since 
the affected area during any particular emergency is unknown ahead of 
time, the transplant center may have an agreement with another 
transplant center that is also affected by the same emergency. They 
also noted that, since the circumstances of each natural and man-made 
disaster would be different, any plans made ahead of time may be 
unworkable during an actual emergency. They noted that, in each 
emergency, the affected geographic area has to be taken into 
consideration, in addition to the services and patients affected. In 
addition to being of little value, they noted that emergency plans may 
provide a false sense of security. Also, in some areas of the country, 
the great geographical distances between transplant centers would make 
agreements with another center both overly burdensome and impractical.
    Response: We believe that emergency preparedness is essential for 
healthcare entities. Also, emergency preparedness plans should be 
flexible enough to allow for emergencies that affect both the local 
area, as well emergencies that may affect a larger area, such as 
regional and national emergencies. However, we do agree with the 
commenters that the great geographical distances between some of the 
transplant centers could result in making agreements between the 
centers burdensome and impractical. Therefore, we are not finalizing 
the requirement for agreements with between transplant centers as 
proposed. Instead, based on our analysis of the comments, we have 
decided to require that transplant centers be actively involved in 
their hospital's emergency planning and programming. We believe this 
requirement will ensure that the needs of each transplant center are 
addressed in the hospital's program. Also, transplant centers must be 
involved in the development of mutually-agreed upon protocols that 
addresses the duties and responsibilities of the hospital, transplant 
program, and OPO during emergencies. These changes are discussed in 
more detail later in this final rule.
    Comment: Some commenters expressed concerns about how transferring 
transplant recipients and those on the waiting lists to another 
transplant center would affect both these patients and those at the 
receiving transplant center. Since each transplant program develops its 
own patient selection criteria and, if the transplant center performs 
living donor transplants, living donor selection criteria, this could 
result in some patients not being acceptable to the transplant center 
that agrees to care for patients from another transplant center that is 
experiencing an emergency. A commenter noted that OPTN Policy 3.4B 
prohibits transplant hospitals from registering a candidate on a 
waiting list for an organ if that transplant center does not have 
current OPTN approval for that type of organ (accessed at http://optn.transplant.hrsa.gov/ContentDocuments/OPTN_Policies.pdf#nameddest=Policy_01 on February 24, 2015). In 
addition, depending upon the length of time of the emergency, there 
could be issues regarding how the waiting list patients would be 
integrated with the receiving transplant center's own waiting list 
patients. There was some concern that, depending on how the transfer 
was conducted, some of the transferring waiting list patients could 
receive preferential treatment over the receiving transplant center's 
waiting list patients. Also, there were some concerns about how patient 
records or other relevant information would be transferred. In 
addition, there was a concern about whether CMS and the OPTN would 
grant any exceptions or modifications to the required statistics and 
outcome measures during an emergency, especially if the transferring 
patients do not meet the receiving facility's selection criteria.
    Response: We agree that there could be issues when patients are 
transferred from one transplant center to another. However, our 
requirements do not oblige a transplant center that agrees to care for 
another transplant center's patients during an emergency to put those 
patients on its waiting lists. We anticipate that most emergencies 
would be of short duration and that the transplant center that is 
affected by an emergency will resume its normal operations within a 
short period of time. However, if a transplant center does arrange for 
its patients to be transferred to another transplant center during an 
emergency, both transplant centers would need to determine what care 
would be provided to the transferring patients, including whether and 
under what circumstances the patients from

[[Page 63908]]

the transferring transplant center would be added to the receiving 
center's waiting lists.
    Concerning exceptions or modifications to the required statistics 
and outcome measures for operations during an emergency, we believe 
that is beyond the scope of this final rule. We would note that the 
current survey, certification, and enforcement procedures already 
provide for transplant centers to request consideration for mitigating 
factors in both the initial and re-approval processes for their center 
as set forth in Sec.  488.61(f). In addition, there are specific 
requirements for requests related to natural disasters and public 
health emergencies (Sec.  488.61(f)(2)(vii)).
    Comment: Some commenters expressed concern that our proposed 
requirements would interfere with or contradict OPTN policies. A 
commenter specifically noted that, in the preamble to the proposed 
rule, we stated that ``[i]deally, 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'' (78 FR 79108). The commenter noted that OPTN 
Policy 3.4.B states that ``[m]embers are only permitted to register a 
candidate on the waiting list for an organ at a transplant program if 
the transplant program has current OPTN transplant program approval for 
that organ type.''
    Response: We disagree with the commenters. We do not expect any 
transplant center to violate any of the OPTN's policies. We are not 
finalizing the proposed requirement for transplant centers to have 
agreements with another transplant center because we now believe that 
requirement may be burdensome and impractical for some transplant 
centers as we have discussed earlier. However, if a transplant center 
choses to have an agreement with another transplant center to care for 
its patients during an emergency, there is no requirement for the 
receiving center to place those patient on its waiting lists. The 
receiving transplant center would likely only provide care for the 
duration of the emergency and then those patients would return to their 
original transplant center. However, what care was to be provided 
should be decided by the transplant centers prior to any emergency. 
Also, as stated earlier, the OPTN's policies are not comprehensive. For 
example, they do not cover local emergencies or the other specific 
requirements in this final rule, that is, requirements for a risk 
assessment, specific policies and procedures, an emergency plan, a 
communication plan, and training and testing. In addition, as described 
earlier, including emergency preparedness requirements in the 
transplant center CoPs provides us with oversight and enforcement 
authority we do not have for the OPTN policies.
    Comment: A few commenters stated that the proposed transplant 
center requirements were unnecessary. The transplant center should be 
embedded in the hospital's overall emergency plan so that transplant 
patients would be considered along with all of the other patients in 
the hospital. Another commenter suggested that this agreement not be 
between different transplant centers but the hospitals in which they 
are located, or even part of a larger or regional emergency plan.
    Response: We agree with the commenters that the transplant center's 
emergency preparedness plans should be included in the hospital's 
emergency plans. All of the Medicare-approved transplant centers are 
located within hospitals and, as part of the hospital, should be 
included in the hospital's emergency preparedness plans. In addition, 
if transplant centers were required to separately comply with all of 
the requirements in Sec.  482.15, it would be tremendously burdensome 
to the transplant centers. For example, we believe that the transplant 
center needs to be involved in the hospital's risk assessment because 
there may be risks to the transplant center that others in the hospital 
may not be aware of or appreciate. However, most of the risk assessment 
would be the same since the transplant center is located in the 
hospital; a separate risk assessment would unnecessary and overly 
burdensome. Therefore, we have modified Sec.  482.68(b) so that 
transplant centers are exempt from the emergency preparedness 
requirements in Sec.  482.15 and added a requirement in Sec.  482.15(g) 
that requires transplant hospitals to have a representative from each 
transplant center actively involved in the development and maintenance 
of the hospital's emergency preparedness program. In addition, 
transplant centers would still be required to have their own emergency 
preparedness policies and procedures, as well as participate in 
mutually-agreed upon protocols that address the transplant center, 
hospital, and OPO's duties and responsibilities during an emergency.
    Comment: Some commenters recommended that, instead of requiring 
agreements between transplant centers and OPOs as we had proposed, we 
should require hospitals, transplant centers, and OPOs to develop 
mutually agreed-upon protocols for addressing emergency situations. 
These commenters pointed out that since we proposed that emergency 
plans be reviewed and updated annually and that changes be incorporated 
based upon new information, protocols would be more conducive to timely 
and effective improvement. Other commenters noted that certain factors 
that would need to be considered in an emergency, particularly the 
different facility-specific levels of service, geographically based 
hazards, and donor potentials, were inappropriate for formal agreements 
but were well suited for protocols.
    Response: We agree with the commenters. We believe that mutually 
agreed-upon protocols between the transplant centers, the hospitals in 
which the transplant centers operate, and the OPOs are the best 
approach to address emergency preparedness for these facilities. 
Therefore, we are not finalizing the requirement at proposed Sec.  
482.78 that a transplant center or the hospital in which it operates 
have an agreement with another transplant center, or the requirement 
that the agreement required at Sec.  486.100 include the duties and 
responsibilities of the OPO and hospital during an emergency. Instead, 
we have revised the requirements for transplant centers, the hospitals 
in which they operate, and OPOs to specify that these facilities must 
have mutually agreed-upon protocols that state the duties and 
responsibilities of each during an emergency. We believe this approach 
will not only achieve our goal of having these facilities prepared for 
emergencies but will also impose only minimal burden. Section 
486.344(d) currently requires that OPOs have protocols with transplant 
centers and Sec.  482.100 requires that transplant centers ensure that 
the hospitals in which they operate have written agreements for the 
receipt of organs with an OPO designated by the Secretary that 
identifies specific responsibilities for the hospital and for the OPO 
with respect to organ recovery and organ allocation according to Sec.  
482.100. In addition, since most, if not all, of these facilities must 
have previously encountered emergencies, we believe that establishing 
these protocols should require a much smaller burden than developing an 
agreement.

[[Page 63909]]

    After consideration of the comments we received on those changes in 
the proposed rule, as discussed earlier and in the hospital section 
(section II.C. of this final rule), we are finalizing the proposed 
emergency preparedness requirements for transplant centers with the 
following modifications:
     Adding a requirement at Sec.  482.15(g) that a transplant 
center be actively involved in the hospital's emergency preparedness 
planning and program, and the phrase ``as defined by Sec.  482.70''.
     Modifying Sec.  482.68(b) to exempt transplant centers 
from the requirements in Sec.  482.15.
     Removing the requirement in Sec.  482.78 for transplant 
centers to have agreements with another transplant center.
     Modifying the requirement in Sec.  482.78(b) to require 
that a transplant center be responsible for developing and maintaining 
mutually agreed upon protocols that address the duties and 
responsibilities of the transplant center, hospital, and OPO during an 
emergency.
     Adding ``as defined by Sec.  482.70'' that sets forth the 
definition of a ``transplant hospital'' to clarify which hospitals are 
responsible for complying with Sec.  482.15(g).

J. 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 ``dually eligible individuals'' who 
qualify for both Medicare and Medicaid. As of June 2016, there were 
15,699 LTC facilities and these facilities provided care for about 1.7 
million patients.
    The existing requirements for LTC facilities contain specific 
requirements for emergency preparedness, set out at Sec.  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 
proposed 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 
(2). Section 483.75(m)(1) and (2) would be removed.
    Our proposed emergency preparedness requirements for LTC facilities 
are identical to those we proposed for hospitals at Sec.  482.15, with 
two exceptions. Specifically, at Sec.  483.73(a)(1), we proposed that 
in an emergency situation, LTC facilities would have to account for 
missing residents.
    Section 483.73(c) would requires these facilities to develop an 
emergency preparedness communication plan, which would include, among 
other things, a means of providing information about the general 
condition and location of residents under the facility's care. We 
proposed to add an additional requirement at Sec.  483.73(c)(8) that 
read, ``A method for sharing information from the emergency plan that 
the facility has determined is appropriate with residents and their 
families or representatives.''
    Also, we proposed 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 NFPA[supreg]. 
In addition to the emergency power system inspection and testing 
requirements found in NFPA[supreg] 99, NFPA[supreg] 101, and 
NFPA[supreg] 110, we proposed 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 
would require during an emergency.
    However, we also solicited comments on whether there should be a 
specific requirement for ``residents' power needs'' in the LTC 
requirements.
    Comment: Some commenters recommended that LTC facilities be 
required to include patients, their families, and relevant stakeholders 
throughout the emergency preparedness planning and testing process. 
They recommended that the method of providing information from the 
emergency plan be clearly communicated with residents, representatives, 
and caregivers and that the LTC facilities follow a specific time frame 
to provide this communication. Some commenters recommended that PACE 
facilities and HHAs be required to include patients and their families 
in the emergency preparedness planning as well.
    A few commenters recommended that LTC facilities include their 
state Long-Term Care Ombudsman Program in this planning process. Some 
commenters also recommended that LTC facilities provide the Program 
with a completed emergency plan.
    Response: As we stated in the proposed rule, LTC facilities are 
unlike many of the inpatient care providers. Many of the residents have 
long term or extended stays in these facilities. Due to the long term 
nature of their stays, these facilities essentially become the 
residents' homes. We believe this fact changes the nature of the 
relationship with the residents and their families or representatives.
    We continue to 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 
are finalizing our proposal at Sec.  483.73(c)(8) that LTC facilities 
develop and maintain a method for sharing information from the 
emergency plan that the facility has determined is appropriate with 
residents and their families or representatives. We note that we are 
not requiring that PACE and HHA providers share information from the 
emergency plan with families and their representatives. However, these 
providers can choose to share information with any appropriate party, 
so long as they comply with federal, state, and local laws.
    We are not requiring LTC facilities to share information with 
stakeholders, or Long-Term Care Ombudsman Program representatives, 
because we believe

[[Page 63910]]

such a requirement could be overly burdensome for the LTC facilities. 
We believe that facilities need the flexibility to develop their 
emergency plans and determine what portions of those plans and the 
parties with whom those plans should be shared. If a facility 
determines that it is appropriate and timely to share either the 
complete emergency plan, or certain portions of it, with stakeholders 
or representatives from the Long-Term Care Ombudsman Program, we 
encourage them to do so. Therefore, we are finalizing our proposal at 
Sec.  483.73(c)(2)(iii) that LTC facilities maintain the contact 
information for the Office of the State Long-Term Care Ombudsman.
    Comment: A majority of commenters expressed support for the 
proposal that requires LTC facilities to develop a communications plan. 
A few commenters also supported CMS' proposal to require LTC facilities 
to share information from the emergency plan that the facility has 
determined is appropriate with residents and their families or 
representatives. A commenter recommended that LTC facilities follow a 
specific timeframe to provide this communication.
    Response: We appreciate the commenters' support. We note that we 
are not requiring specific timeframes for LTC facility communications 
in these emergency preparedness requirements. We are allowing 
facilities the flexibility to make the determination on when emergency 
preparedness plans and information should be communicated with the 
relevant entities during an emergency or disaster.
    Comment: A commenter specifically recommended that CMS issue 
guidance to facilities regarding steps to disseminate information about 
the emergency plan to the general public. These steps would include 
posting the plan on the facility's Web site, if available, making a 
hard copy available for review at the facility's front desk; providing 
a notice to residents upon entering a facility that they or their 
representative can receive a free electronic copy at any time by 
providing their email address, and proving a copy of the plan in 
electronic format to local entities that are a resource for families 
during a disaster. A commenter recommended that CMS require LTC 
facilities to make the plans available to residents and their 
representatives upon request. According to the commenter, information 
that the facility shares should be written in clear and concise 
language and the facility's Web site could be a place for current, 
updated information.
    Response: We agree with the commenter that transparency in 
communication is important. Therefore, we are requiring that LTC 
facilities have a method for sharing appropriate information with 
residents and their families or representatives. Consistent with our 
belief that these emergency preparedness requirements should afford 
facilities flexibility, we do not believe that it is appropriate to 
require that LTC facilities take specific steps or utilize specific 
strategies to share these documents with residents and their families 
or representatives.
    Comment: A commenter stated that the communication plan requirement 
is broad and will lead to inconsistent approaches for facilities. 
Furthermore, the commenter noted that this will cause compliance and 
enforcement of the rule to be subjective.
    Response: The proposed emergency preparedness regulations provide 
the minimum requirements that facilities must follow. This allows a 
variety of facilities, ranging from small rural providers to large 
facilities that are part of a franchise or chain, the flexibility to 
develop communication plans that are specific to the needs of their 
resident population and facility. Additionally, we have written these 
regulations with the intention to allow for flexibility in how 
facilities develop and maintain their emergency preparedness plans.
    In addition to the CoPs/CfCs, interpretative guidelines (IGs) will 
be developed for each provider and supplier types. We also note that 
surveyors will be provided training on the emergency preparedness 
requirements, so that enforcement of the rule will be based on the 
regulations set forth here.
    Comment: A commenter noted that the proposed requirements for a 
communication plan for LTC facilities do not mention a waiver that 
would allow for sharing of client information, which would create a 
potential violation of HIPAA. Furthermore, the commenter requested 
clarification in the final rule.
    Response: As we stated previously in this final rule, HIPAA 
requirements are not suspended during a national or public health 
emergency. Thus, the communication plan is to be created consistent 
with the HIPAA Rules. See http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/hipaa-privacy. http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/hipaa-privacy-emergency-
situations.pdf, for more information on how HIPAA applies in emergency 
situations.
    Comment: A commenter stated that LTC facilities should consider 
multiple options for transportation in planning for an evacuation. 
Another commenter recommended that there should be coordination between 
vendors that provide transportation services for LTC facility residents 
with other facilities and community groups to avoid having too many 
providers relying on a few vendors.
    Response: We agree with the commenters that it is preferable for 
facilities to have multiple options for the provision of services, 
including transportation, and that those services be coordinated so 
that they are used efficiently. We also encourage facilities to 
coordinate with other facilities in their geographic area to determine 
if their arrangements with any service provider are realistic. For 
example, if two LTC facilities in the same city are depending upon the 
same transportation vendor to evacuate their residents, both facilities 
should ensure that the vendor has sufficient vehicles and personnel to 
evacuate both facilities. Also, we believe that the requirements for 
testing that are set forth in Sec.  483.73(d)(2), especially the full-
scale exercise, should provide facilities with the opportunity to test 
their emergency plans and determine if they need to include multiple 
options for services and whether those services have been coordinated.
    Comment: Due to the difficulty that the training requirement would 
place on smaller LTC facilities, a commenter suggested that we allow 
training by video demonstration, webinar, or by association-sponsored 
programs where regional training can be given to the staff of several 
facilities simultaneously. The commenter pointed out that group 
training would also bring about more in-depth discussion, questions, 
and comments.
    Response: We agree that these training styles could be beneficial. 
Our proposed requirement for emergency preparedness training does not 
limit training types to within the facility only.
    Comment: CMS solicited comments on whether LTC facilities should be 
required to provide the necessary electrical power to meet a resident's 
individualized power needs. Some organizations recommended that the 
regulation include specific requirements for a ``resident's power 
needs.'' However, many commenters were opposed to this requirement. 
Opposing commenters stated that in an emergency, based on the emergency 
and available resources, things such as medically sustaining life 
support equipment would be needed rather than a powered wheelchair and 
the individual facility would be best at making that determination. 
Some

[[Page 63911]]

commenters recommended that the final regulation state that power needs 
would be managed by the providers based on priority to address critical 
equipment and systems both for individual needs as well as the needs of 
the entire facility.
    Response: We appreciate the feedback that we received from 
commenters on this issue. We agree that the needs of the most 
vulnerable residents should be considered first and expect that 
facilities would take the needs of their most vulnerable population 
into consideration as part of their daily operations. At Sec.  
483.73(a)(3) we require that the facility's emergency plan address 
their resident population to include persons at-risk, the type of 
services the facility has the ability to provide in an emergency, and 
continuity of their operations. We agree with commenters, and want 
facilities to have the flexibility to conduct their risk assessment, 
individually assess their population, and determine in their plans how 
they will meet the individual needs of their residents. We believe that 
the individual power needs of the residents are encompassed within the 
requirement that the facility assess its resident population. 
Therefore, we are not adding a specific requirement for LTC facilities 
to provide the necessary power for a resident's individualized power 
needs. However, we encourage facilities to establish policies and 
procedures in their emergency preparedness plan that would address 
providing auxiliary electrical power to power dependent residents 
during an emergency or evacuating such residents to alternate 
facilities. If a power outage occurs during an emergency or disaster, 
power dependent residents will require continued electrical power for 
ventilators, speech generator devices, dialysis machines, power 
mobility devices, certain types of durable medical equipment, and other 
types of equipment that are necessary for the residents' health and 
well-being. We therefore reiterate the importance of protecting the 
needs of this vulnerable population during an emergency.
    Comment: A commenter objected to our proposal to require LTC 
facilities to have policies and procedures that addressed alternate 
sources of energy to maintain sewage and waste disposal. The commenter 
indicated that the provision and restoration of sewage and waste 
disposal systems may well be beyond the operational control of some 
providers.
    Response: We agree with the commenter that the provision and 
restoration of sewage and waste disposal systems could be beyond the 
operational control of some providers. However, we are not requiring 
LTC facilities to have onsite treatment of sewage or to be responsible 
for public services. LTC facilities would only be required to make 
provisions for maintaining the necessary services.
    Comment: A commenter noted that the proposed requirements do not 
address the issue of regional evacuation. This commenter believed that 
this was an essential part of an emergency plan and that the plan must 
address transportation and accommodations for people with physical, 
intellectual, or cognitive impairments. The commenter also recommended 
that the regional evacuation plan account for long-term sheltering and 
that there be specific standards for sheltering-in-place. Also, they 
believed that LTC facilities should be required to adopt the 2007 EP 
checklist that was issued by CMS.
    Response: We agree with the commenter that the emergency plans for 
LTC facilities should address regional as well as local evacuations and 
long-term as well as short-term sheltering-in-place. However, we are 
finalizing the requirement for the emergency plan to be based upon a 
facility-based and community-based risk assessment, utilizing an all-
hazards approach (Sec.  483.73(a)(1)). The ``all-hazards'' approach 
includes emergencies that could affect only the facility as well as the 
community in which it is located and beyond. It also includes 
emergencies that are both short-term and long-term. When facilities are 
developing their risk assessments, they should be considering all of 
those possibilities. We disagree about the recommendation that we 
propose more specific standards on sheltering-in-place. We believe that 
each facility needs the flexibility to develop its own plans for 
sheltering-in-place for both short and long-term use. We also disagree 
about requiring adoption of the 2007 CMS EP checklist, which can be 
found at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/SandC_EPChecklist_Persons_LTCFacilities_Ombudsmen.pdf.
    That checklist is a resource that facilities may use. In addition, 
over time CMS may publish updates or other checklists or facilities may 
choose to use tools from other resources.
    Comment: A commenter agreed with us that LTC facilities should have 
plans concerning missing residents. The current LTC requirements 
require LTC facilities have plan for emergencies, including missing 
residents (Sec.  483.75(m)). However, the commenter also believed that 
this requirement could be confusing and that we should clarify that 
facilities should have plans to account for missing residents in both 
emergency and non-emergency situations.
    Response: We agree with the commenter that LTC facilities must have 
plans concerning missing residents that can be activated regardless of 
whether the facility must activate its emergency plan. A missing 
resident is an emergency and LTC facilities must have a plan to account 
for or locate the missing resident.
    Comment: Some commenters wanted more clarification on the 
requirements for LTC facilities to have policies and procedures that 
address subsistence needs for staff and residents, particularly related 
to medical supplies and temperature to protect resident health and 
safety and for safe and sanitary storage of provisions. A commenter 
requested additional guidance and clarification on medical supplies. 
They questioned whether ``supplies'' would include individual 
residents' medications and, if it did, how that affected prescribing 
limits, payment systems, access, etc. Furthermore, a commenter wanted 
clarification on power requirements for temperatures. Another commenter 
recommended we specify a minimum for all needed supplies and 
provisions.
    Response: We have not required minimums for these types of 
requirements because they would vary greatly between facilities. Each 
facility is required to conduct a facility-based and community-based 
assessment that addresses, among other things, its resident population. 
From that assessment, each facility should be able to identify what it 
needs for its resident population, including what medical/
pharmaceutical supplies it needs to maintain and its temperature needs 
for both its resident population and its necessary provisions. As to 
minimum time periods, each facility would need to determine those based 
on its assessment and any other applicable requirements.
    Comment: A commenter recommended that we require specific types of 
medical documentation in proposed Sec.  483.73(b)(5). The commenter 
specifically recommended the inclusion of resident demographics, 
allergies, diagnosis, list of medications and contact information 
(commonly referred to as the ``face sheet'').
    Response: We appreciate the commenter's suggestion. Proposed Sec.  
483.73(b)(5) required that the facility have policies and procedures 
that address ``A system of medical documentation that preserves 
resident

[[Page 63912]]

information, protects confidentiality of resident information, and 
ensures records are secure and readily available.'' While the types of 
documentation the commenter identified will probably be included in 
that documentation, we believe that facilities need the flexibility to 
determine what will be included in the medical documentation and how 
they will develop these systems. Thus, we are finalizing this provision 
as proposed.
    After consideration of the comments we received on the proposals, 
and the general comments we received on the proposed rule, as discussed 
earlier in the hospital section (section II.C. of this final rule), we 
are finalizing the proposed emergency preparedness requirements for LTC 
facilities with the following modifications:
     Revising the introductory text of Sec.  483.73 by adding 
the term ``local'' to clarify that LTC facilities must also comply with 
local emergency preparedness requirements.
     Revising Sec.  483.73(a) to change the term ``ensure'' to 
``maintain.''
     Revising Sec.  483.73(b)(1)(i) to state that LTC 
facilities must have policies and procedures that address the need to 
sustain pharmaceuticals during an emergency.
     Revising Sec.  483.73(b)(2) by clarifying that tracking 
during and after the emergency applies to on-duty staff and sheltered 
residents. We have also revised paragraph (b)(2) to provide that if on-
duty staff and sheltered residents are relocated during the emergency, 
the facility must document the specific name and location of the 
receiving facility or other location.
     Revising Sec.  483.73(b)(5) to replace the phrase 
``ensures records are secure and readily available'' to ``secures and 
maintains availability of records.''
     Revising Sec.  483.73(b)(7) to replace the term ``ensure'' 
with ``maintain.''
     Revising Sec.  483.73(c) by adding the term ``local'' to 
clarify that the LTC facility must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.
     Revising Sec.  483.73(c)(5) to clarify that the LTC 
facility must develop a means, in the event of an evacuation, to 
release patient information, as permitted under 45 CFR 
164.510(b)(1)(ii).
     Revising Sec.  483.73(d) by adding that each LTC 
facility's training and testing program must be based on the LTC 
facility's emergency plan, risk assessment, policies and procedures, 
and communication plan.
     Revising Sec.  483.73(d)(1)(iv) to replace the phrase 
``Ensure that staff can demonstrate knowledge'' with ``Demonstrate 
staff knowledge.''
     Revising Sec.  483.73(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  483.73(d)(2)(ii) to allow a LTC facility to 
choose the type of exercise it will conduct to meet the second annual 
testing requirement.
     Revising Sec.  483.73(e)(1) and (2) by removing the 
requirement for additional generator testing.
     Revising Sec.  483.73(e)(2)(i) by removing the requirement 
for an additional 4 hours of generator testing and by clarifying that 
LTC facilities must meet the requirements of NFPA[supreg] 99, 2012 
edition and NFPA[supreg] 110, 2010 edition.
     Revising Sec.  483.73(e)(3) by removing the requirement 
that LTC facilities maintain fuel quantities onsite and clarify that 
LTC facilities must have a plan to maintain operations unless the LTC 
facility evacuates.
     Adding Sec.  483.73(f) to allow a separately certified LTC 
facility within a healthcare system to elect to be a part of the 
healthcare system's emergency preparedness program.
     Adding a new Sec.  483.73(g) to incorporate by reference 
the requirements of 2012 NFPA[supreg] 99, 2012 NFPA[supreg] 101, and 
2010 NFPA[supreg] 110.

K. Emergency Preparedness Regulations for Intermediate Care Facilities 
for Individuals With Intellectual Disabilities (ICF/IIDs) (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. Sec.  483.400 through 483.480. As 
of June 2016, there were 6,237 ICFs/IID, serving approximately 129,000 
clients, and all clients receiving ICF/IID services must qualify 
financially for Medicaid assistance under their applicable state plan. 
Clients with intellectual disabilities who receive care provided by 
ICF/IIDs 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.
    Because ICF/IIDs 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. However, we believe 
each of them has the capability to comply fully with the requirements 
so that the health and safety of its clients are protected in the event 
of an emergency situation or disaster.
    Thus, we proposed to require that ICF/IIDs meet the same 
requirements we proposed for hospitals, with two exceptions. At Sec.  
483.475(a)(1), we proposed that ICF/IIDs utilize an all-hazards 
approach, including plans for locating missing clients. We believe that 
in the event of a natural or man-made disaster, ICF/IIDs would maintain 
responsibility for care of their own client population but would not 
receive patients from the community. Also, because we recognize that 
all ICF/IIDs clients have unique needs, we proposed to require ICF/IIDs 
to ``address the unique needs of its client population . . .'' at Sec.  
483.475(a)(3).
    In addressing the unique needs of their client population, we 
believe that ICF/IIDs should consider their individual clients' power 
needs. For example, some clients 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 
proposed requirements at Sec.  483.475(a) (a risk assessment utilizing 
an all-hazards approach and that the facility address the unique needs 
of its client population) encompass consideration of individual 
clients' power needs and should be included in ICF/IIDs risk 
assessments and emergency plans.
    As we stated earlier, the purpose of this final rule is to 
establish requirements to ensure that Medicare and 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 ICF/IIDs 
are sufficiently comprehensive to protect clients during an emergency 
that impacts the larger community. However, we have been careful not to 
remove emergency preparedness requirements that are more rigorous than 
the additional requirements we proposed.
    For example, our current regulations for ICF/IIDs include 
requirements for emergency preparedness. Specifically, Sec.  
483.430(c)(2) and (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 did not propose to 
relocate these existing facility staffing requirements at Sec.  
483.430(c)(2) and (3) because they

[[Page 63913]]

address staffing issues based on the number of clients per building and 
client behaviors, such as aggression. Such requirements, while related 
to emergency preparedness tangentially, are not within the scope of the 
emergency preparedness requirements for ICF/IIDs.
    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 will be relocated to proposed 
Sec.  483.475(a)(1). Existing Sec.  483.470(h)(1) will 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) will be removed.
    ICF/IIDs 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 their stays, these 
facilities essentially become the clients' residences or homes. 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 did not indicate 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 proposed 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 clients during at least one drill each year on each shift; 
make special provisions for the evacuation of clients 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. Furthermore, during fire drills, 
facilities may evacuate clients 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 Sec.  483.470(i)(1) and (2) for any live-in and relief 
staff they utilize. Because these existing requirements are so 
extensive, we proposed cross referencing Sec.  483.470(i) (redesignated 
as Sec.  483.470(h)) at proposed Sec.  483.475(d).
    Comment: A commenter recommended that CMS include language that 
would exclude community-based residential services servicing three or 
fewer residents. The commenter noted that implementing the same 
emergency preparedness requirements as ICF/IID facilities for community 
based residential services would be cost prohibitive.
    Response: A community-based residential facility with less than 4 
beds would not meet the definition of an ICF/IID and would not be 
covered under this regulation. We encourage facilities that are 
concerned about the implementation of emergency preparedness 
requirements to refer to the various resources noted in the proposed 
and final rules, and participate in healthcare coalitions within their 
community for support in implementing these requirements.
    Comment: A commenter agreed with CMS' proposal that ICF/IID 
providers' communication plans be shared with the families of their 
clients. The commenter noted that an annual correspondence to families, 
with intermediate updates as changes or additions are made, should not 
be burdensome to facilities.
    Response: We appreciate the commenter's support. We have not set 
specific requirements for when or how often ICF/IID facilities should 
correspond with families and their representatives. However, facilities 
can choose to correspond with clients' families and their 
representatives as frequently as they deem appropriate.
    Comment: Multiple commenters expressed their opposition to the 
requirement for ICF/IIDs to hold evacuation drills at least quarterly 
for each shift for personnel under varied conditions. Each commenter 
stated that quarterly evacuation drills are costly and will require the 
unnecessary movement of clients which could result in liability issues 
as well as disrupt operations.
    Response: The requirement for quarterly evacuation drills is one of 
the requirements in the existing regulations for ICF/IIDs at Sec.  
483.470(i) (proposed to be redesignated to Sec.  483.470(h)). We stated 
in the proposed rule that the purpose of the rule was to establish 
requirements to ensure that Medicare and Medicaid providers and 
suppliers are prepared to protect the health and safety of patients in 
their care during a widespread emergency. While we did not believe that 
the existing requirements for ICF/IIDs are sufficiently comprehensive 
enough to protect clients during an emergency that impacts the larger 
community, we were careful not to remove emergency preparedness 
requirements that are more rigorous than those additional requirements 
we proposed. Therefore, we proposed to retain this requirement. We 
believe that, unlike many of the inpatient care providers due to the 
long term nature of their clients stays, ICF/IIDs have a heightened 
responsibility to ensure the safety of their clients given that these 
facilities essentially become the clients' residences or homes.
    Comment: A commenter expressed their support for the emphasis that 
the proposed rule placed on drills and testing for this vulnerable 
population and pointed out that many accrediting organizations require 
ICF/IIDs to test their emergency management plans each year.
    Response: We thank the commenter for their support and agree that 
drills and testing are an important aspect of developing a 
comprehensive emergency preparedness program.
    Comment: A commenter stated that the proposed requirement to place 
a generator in each home and to test it annually would be extremely 
costly.
    Response: We would like to clarify that we did not propose a 
requirement for generators to be placed in each ICF/IID facility. We 
proposed additional testing requirements for hospitals, CAHs, and LTC 
facilities. However, due to the numbers of comments we received stating 
that the requirement for additional testing would be overly burdensome 
and unnecessary. We have removed this requirement in the final rule.

[[Page 63914]]

    After consideration of the comments we received on these provisions 
of the proposed rule, and the general comments we received, as 
discussed in the hospital section (section II.C. of this final rule), 
we are finalizing the proposed emergency preparedness requirements for 
ICF/IIDs with the following modifications:
     Revising the introductory text of Sec.  483.475, by adding 
the term ``local'' to clarify that ICF/IIDs must also comply with local 
emergency preparedness requirements.
     Revising Sec.  483.475(a)(4) by deleting the term 
``ensuring'' and replacing the term ``ensure'' with ``maintain.''
     Adding at Sec.  483.475(b)(1)(i) that ICF/IIDs must have 
policies and procedures that address the need to sustain 
pharmaceuticals during an emergency.
     Revising Sec.  483.47(b)(2) by clarifying that tracking 
during and after the emergency applies to on-duty staff and sheltered 
clients. We have also revised paragraph (b)(2) to provide that if on-
duty staff and sheltered residents are relocated during the emergency, 
the facility must document the specific name and location of the 
receiving facility or other location.
     Revising Sec.  483.475(b)(5) to change the phrase 
``ensures records are secure and readily available'' to ``secures and 
maintains availability of records;'' also revising paragraph (b)(7) to 
change the term ``ensure'' to ``maintain.''
     Revising Sec.  483.475(b)(1), (b)(1)(ii)(A), and (b)(2) to 
replace the term ``residents'' to ``clients.'' Throughout the preamble 
discussion, the terms ``patients and residents'' have been deleted and 
replaced with the term ``client.''
     Revising Sec.  483.475(c) by adding the term ``local'' to 
clarify that ICF/IIDs must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.
     Revising Sec.  483.475(c)(5) to clarify that ICF/IIDs must 
develop a means, in the event of an evacuation, to release patient 
information, as permitted under 45 CFR 164.510(b)(1)(ii).
     Revising Sec.  483.475(d) by adding that each ICF/IID's 
training and testing program must be based on the ICF/IID's emergency 
plan, risk assessment, policies and procedures, and communication plan.
     Revising Sec.  483.475(d)(1)(iv) to replace the phrase 
``Ensure that staff can demonstrate knowledge'' to ``Demonstrate staff 
knowledge.''
     Revising Sec.  483.475(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  483.475(d)(2)(ii) to allow an ICF/IIDs to 
choose the type of exercise it will conduct to meet the second annual 
testing requirement.
     Adding Sec.  483.475(e) to allow a separately certified 
ICF/IID within a healthcare system to elect to be a part of the 
healthcare system's emergency preparedness program.

L. 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 June 2016, there were 
12,335 HHAs participating in the Medicare program. The majority of HHAs 
are for-profit, privately owned agencies. There are no existing 
emergency preparedness requirements in the HHA Medicare regulations at 
part 484, subparts B and C.
    We proposed to add emergency preparedness requirements at Sec.  
484.22, under which HHAs would be required to comply with some of the 
requirements that we proposed for hospitals. We proposed additional 
requirements under the HHA policies and procedures that would apply 
only to HHAs to address the unique circumstances under which HHAs 
provide services.
    Specifically, we proposed 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 proposed that the HHA include 
individual emergency preparedness plans for each patient as part of the 
comprehensive patient assessment at Sec.  484.55.
    At Sec.  484.22(b)(2), we proposed to require that an HHA to have 
policies and procedures to inform federal, 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 Rule, 
as appropriate.
    We did not propose to require that HHAs meet all of the same 
requirements that we proposed for hospitals. Since HHAs provide 
healthcare services only in patients' homes, we did not propose 
requirements for policies and procedures to meet subsistence needs 
(Sec.  482.15(b)(1)); safe evacuation (Sec.  482.15(b)(3)); or 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's main or branch offices. We did 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 the local health department and emergency 
management officials. With respect to communication, we did not propose 
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 
propose 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 proposed to 
require HHAs to provide information about the HHA's needs and its 
ability to provide assistance to the local health department authority 
having jurisdiction or the Incident Command Center, or designee.
    Comment: Several commenters stated that, despite our efforts, our 
proposed requirements for HHAs were not tailored for organizations that 
provide home-based services. Commenters indicated that we did not 
provide a complete description of our vision for the role that HHAs 
would play during and emergency and requested more clarity. A commenter 
requested that we work with the stakeholder community to develop a 
better understanding of how HHAs function, the needs of their patients, 
the communities in which they deliver services, and their resources.
    Response: We appreciate the commenters' feedback. Many patients 
depend on the services of HHAs nationwide and the effective delivery of 
quality home health services is essential to the care of illnesses and 
prevention of hospitalizations. It is imperative that HHAs have 
processes in place to address the safety of patients and staff and the 
continued provision of services

[[Page 63915]]

in the event of a disaster or emergency. We do not envision that HHAs 
will perform roles outside of their capabilities during an emergency. 
In addition, some HHAs that have agreements with hospitals already 
assist hospitals when at surge capacity. Home care professionals also 
have first-hand experience working in non-structured care environments. 
This experience has proven to be helpful in situations where patients 
are trapped in their homes or housed in shelters during a disaster or 
emergency. We also believe that because HHAs provide home care, they 
have first-hand knowledge of medically compromised individuals who have 
the potential to be trapped in their homes and unable to seek safe 
shelter during an emergency. This information is invaluable to state 
and local emergency preparedness officials. All of these activities and 
resources that HHAs have are necessary for effective community 
emergency preparedness planning.
    We understand that one approach may not work for some and that 
community involvement will depend on the specific needs and resources 
of the community. However, we believe that establishing these emergency 
preparedness requirements for HHAs, and the other provider and 
suppliers, encourages collaboration and coordination that allows for a 
consistent, yet flexible regulatory framework across provider and 
supplier types. We would expect that HHAs will be proactive in their 
role of collaborating in community emergency preparedness planning 
efforts on both the national and local level. Through these efforts we 
believe that stakeholders will gain the opportunities to educate and 
define their role in state and local emergency planning.
    Comment: Many commenters from an advocacy organization for HHAs 
agreed with the requirement that HHAs have policies and procedures that 
include individual emergency preparedness plans for each patient as 
part of the comprehensive patient assessment. However, several 
commenters requested clarification regarding our proposal. Commenters 
indicated that often times, during an emergency, a home care patient or 
their family may make different decisions and evacuate the patient, 
which largely negates any benefit from individualized plans. Commenters 
stated that HHAs should be required to instead provide planning 
materials to each patient upon assessment to assist them with 
developing a personal emergency plan. Some commenters indicated that 
patients should develop their own emergency plans based on their unique 
circumstances and requiring home health nurses to prepare emergency 
plans for their patients falls outside the scope of their practice. 
Most of the commenters supported the inclusion of a requirement for 
home health patients to have a personal emergency plan, but noted that 
CMS should keep in mind that the individual plans are only a starting 
place to locate and serve patients and may not be applicable to every 
type of emergency. A commenter suggested that we not link the 
identification of the patients' needs during an emergency to the 
patient assessment, but rather require that it occur within the first 
two weeks after the start of care to allow for staff to ensure the 
patient's acute care needs are met and remain first priority. In 
addition, some commenters recommended that each HHA be required to 
provide new patients and their families with a copy of the HHA's 
emergency policy and to inform them of the requirement that each new 
patient receive an individual emergency service plan. They also 
recommended providing a copy of the HHA's policies to the long-term 
care ombudsman programs that are involved in home healthcare.
    Response: We appreciate the comments that we received on this 
issue. As a result of the comments, we agree that further clarification 
is needed. We also agree that all patients, their families and 
caregivers should be provided with information regarding the HHA's 
emergency plan and appropriate contact information in the event of an 
emergency. We did not intend for HHAs to develop extensive emergency 
preparedness plans with their patients. We proposed that HHAs include 
individual emergency preparedness plans for each patient as part of the 
comprehensive patient assessment required at Sec.  484.55. 
Specifically, current regulations at Sec.  484.55 require that each 
patient must receive, and an HHA must provide, a patient-specific, 
comprehensive assessment that accurately reflects the patient's current 
health status. In addition, regulations at Sec.  484.55(a)(1) require 
that a registered nurse must conduct an initial assessment visit to 
determine the immediate care and support needs of the patient. As such, 
we believe that HHAs are already conducting and developing patient 
specific assessments and during these assessments, we expect that it 
will be minimally burdensome for HHAs to instruct their staff to assess 
the patient's needs in the event of an emergency.
    We expect that HHAs already assist their patients with knowing what 
to do in the event of an emergency and the possibility that they may 
need to provide self-care if agency personnel are not available. For 
example, discussions to develop the individualized emergency 
preparedness plans could include potential disasters that the patient 
may face within the home such as fire hazards, flooding, and tornados; 
and how to contact local emergency officials. Discussions may also 
include education on steps that can be taken to increase the patient's 
safety. The individualized plan would be the written answers and 
solutions as a result of these discussions and could be as simple as a 
detailed emergency card developed with the patient. As commenters have 
indicated that often time patients choose to negate their plans and 
evacuate, we would expect that HHAs would use the individualized 
emergency plan to instruct patients on agency notification protocols 
for patients that relocate during an emergency and provide patients 
with information about the HHAs emergency procedures. HHAs could also 
use the individualized emergency plan to identify out of state contacts 
for each patient if available. HHA personnel should document that these 
discussions occurred. We are not requiring that HHAs provide their 
emergency plan and policies to any long-term care ombudsman programs, 
but we would encourage cooperation between various agencies.
    Comment: Several commenters stated that HHAs and hospices have not 
been included in community emergency preparedness planning initiatives, 
nor have they received additional emergency planning funding. The 
commenters therefore requested additional time and flexibility to 
comply with the requirements for a communication plan. A few commenters 
requested clarification on what a communication plan for HHAs would 
entail.
    Response: We understand the commenters' concerns about HHA 
providers' inclusion in community emergency preparedness planning 
initiatives. We believe that an emergency preparedness plan will better 
prepare HHA providers in case of an emergency or disaster and help to 
facilitate communication between facilities and community emergency 
preparedness agencies.
    In response to the request for additional time, we have set the 
implementation date of these requirements for 1 year following the 
effective date of this final rule to allow facilities time to prepare. 
We also refer readers to the many resources that have been referenced 
in the proposed and

[[Page 63916]]

final rules for guidance on developing an emergency preparedness 
communication plan for HHAs. HHAs are also encouraged to collaborate 
and participate in their local healthcare coalition that will be able 
to help inform and enable them to better understand how other providers 
are implementing the rules as well as provide access to local health 
department and emergency management officials that participate in local 
healthcare coalitions.
    Comment: A few commenters expressed concern about the proposal to 
require that HHAs develop arrangements with other HHAs and other 
providers to receive patients in the event of limitations or cessation 
of operations to ensure the continuity of services to HHA patients. 
Commenters stated that it was unclear how a home-based patient is 
``received'' by a similar entity. The commenters noted that because 
most home health is provided in the home of the patient, care can be 
suspended for a period of time. Commenters also indicated that home 
health patients are not transferred to other HHAs. A commenter also 
stated that home health patients should not be transferred to hospitals 
during an emergency. A home health patient could receive care at other 
care settings, including those set up through emergency management and 
other state and federal government agencies. The commenters requested 
that CMS take these accommodations into consideration when deciding 
whether to finalize this proposal.
    Response: We agree with the commenters. We understand that most 
HHAs would not necessarily transfer patients to other HHAs during an 
emergency and, based on this understanding of the nature of HHAs, we 
believe that HHAs should not be required to establish arrangements with 
other HHAs to transfer and receive patients during an emergency. 
Therefore, we are not finalizing the proposed requirement at Sec.  
484.22(b)(6) and (c)(1)(iv). During an emergency, if a patient requires 
care that is beyond the capabilities of the HHA, we would expect that 
care of the patient would be rearranged or suspended for a period of 
time. However, we note that as required at Sec.  484.22(b)(2), HHAs 
will be responsible 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 patient's medical and psychiatric condition and 
home environment.
    Comment: A commenter indicated that it was unrealistic for HHAs to 
ensure cooperation and collaboration of various levels of government 
entities. The commenter noted that while it is critical that HHAs seek 
inclusion in discussions and understand the emergency planning efforts 
in their area, it has proven difficult for HHAs to secure inclusion. 
The commenter requested that we eliminate the requirement for HHAs to 
include a process for ensuring cooperation and collaboration with 
various levels of government.
    Response: We recognize that some aspects of collaborating with 
various levels of government entities may be beyond the control of the 
HHA. In general, we used the word ``ensure'' or ``ensuring'' to convey 
that each provider and supplier will be held accountable for complying 
with the requirements in this rule. However, to avoid any ambiguity, we 
have removed the term ``ensure'' and ``ensuring'' from the regulation 
text of all providers and suppliers and have addressed the requirements 
in a more direct manner. Therefore, we are finalizing this proposal to 
require that HHAs include in their emergency plan a process for 
cooperation and collaboration with local, tribal, regional, state, and 
federal emergency preparedness officials. As proposed, we also indicate 
that HHAs must include documentation of their efforts to contact such 
officials and, when applicable, of its participation in collaborative 
and cooperative planning efforts.
    Comment: A few commenters requested further clarification in 
regards to our use of the term ``volunteers'' as it relates to HHAs. 
Commenters noted that HHAs are not required to use volunteers and that 
the role of volunteers is not addressed at all in Sec.  484.113.
    Response: We provided information on the use of volunteers in the 
proposed rule (78 FR 79097), specifically with reference to the Medical 
Reserve Corps and the ESAR-VHP programs. Private citizens or medical 
professionals not employed by a facility often offer their voluntary 
services to providers during an emergency or disaster event. Therefore, 
we believe that HHAs should have policies and procedures in place to 
address the use of volunteers in an emergency, among other emergency 
staffing strategies. We believe such policies should address, among 
other things, the process and role for integration of state or 
federally-designated healthcare professionals, in order to address 
surge needs during an emergency. As with previous emergencies, 
facilities may choose to utilize assistance from the MRC or they may 
choose volunteers through the federal ESAR-VHP program. However, we 
want to emphasis that the need and use of volunteers or both is left up 
to the discretion of each individual facility, unless indicated as 
otherwise in their individual regulations.
    Comment: A commenter stated that HHA and hospice providers should 
receive classification as essential healthcare personnel to gain access 
to restricted areas, in order to integrate into community-wide 
emergency communication systems.
    Response: We have no authority to declare HHA and hospice providers 
as essential healthcare personnel in their local emergency management 
groups. We suggest that facilities who would like to gain access to 
restricted areas discuss how they may obtain access to community-wide 
emergency communication systems with their state and local government 
emergency preparedness agencies.
    Comment: A commenter expressed concern about the level of 
technology required for HHAs and hospices to implement the emergency 
preparedness requirements. The commenter stated that this technology is 
expensive and not readily available. The commenter also noted that many 
HHA and hospice providers provide services in rural areas where cell 
phone coverage is limited. The commenter also stated that it is 
dangerous for the staff of HHAs and hospices located in urban areas to 
carry smart phone technology. The commenter finally noted that few HHA 
and hospice agencies provide staff with smart or satellite phones.
    Response: As we discussed previously in this final rule, we are not 
endorsing a specific alternate communication system nor are we 
requiring the use of certain specific devices because of the associated 
burden and the potential obsolescence of such devices. However, we 
expect that facilities would consider using alternate means to 
communicate with staff and federal, state, tribal, regional and local 
emergency management agencies. Facilities can choose to utilize the 
technology suggested in this rule or they can use other types of backup 
communication. For example, if an HHA provider has nurses that work in 
a rural area without cell phone coverage, we would expect that the HHA 
agency would have some other means of communicating with the nurse, 
should an emergency or disaster occur. These means do not necessarily 
have to require sophisticated technology, although the devices 
discussed previously are proven useful communication technology. HHA 
providers are only required to provide,

[[Page 63917]]

in their communication plan, plans for primary and alternate means for 
communicating with their staff and emergency management agencies. 
Facilities are given the discretion to choose what approach works for 
their specific circumstance.
    Comment: In general, most commenters supported the proposed 
standards requiring a HHA to have training and testing programs, but 
suggested some revisions. A commenter stated that we did not provide a 
direct link between the testing requirements and the other requirements 
proposed for HHAs.
    Response: We thank the commenters for their support of our proposed 
training and testing requirements. We believe that the emergency plan 
and policies and procedures cannot be executed without the proper 
training of staff members to ensure they have an understanding of the 
procedures and testing to demonstrate its feasibility and 
effectiveness.
    Comment: We received a few comments on our proposal to require HHAs 
to provide annual training to their staff. A commenter stated that a 
requirement for annual training in emergency preparedness is an 
outdated approach to ensuring the organization is ready to put its plan 
into effect should the need arise. The commenter recommended that we 
revise the requirement by emphasizing the need for HHAs to involve 
staff in testing and other activities that will reinforce understanding 
of policies, procedures and their role in the implementation of the 
emergency plan. Another commenter stated that ongoing annual training 
is unnecessary and duplicative. The commenter suggested that we require 
only initial emergency preparedness training upon hire. Once this 
initial training is completed, copies of the plans and procedures would 
be kept on hand and readily accessible in the event of an emergency. 
The commenter stated that this approach would ensure just as timely and 
effective a response to an emergency as annual education while 
requiring less training time of staff taking away from patient care.
    Response: We thank the commenters for their comments and appreciate 
their recommendations. The requirement for annual training is a 
standard requirement of many Medicare CoPs. We believe that the 
requirement is not outdated and is necessary to ensure that staff is 
regularly updated on their agency's emergency preparedness procedures. 
In our proposed training and testing standards, we stated that we would 
require a HHA to provide training in their emergency preparedness 
procedures to all new and existing staff. We also stated that a HHA 
must ensure that staff can demonstrate knowledge of their agency's 
emergency procedures. The emergency preparedness plan should be more 
than a set of written instructions that is referred to in an emergency. 
Rather, it should consist of policies and procedures that are 
incorporated into the facility's daily operations so that it is 
prepared to respond effectively during a disaster. Regular training and 
testing will ensure consistent staff behavior during an emergency, and 
also help to identify and correct gaps in the plan. In addition, we 
believe that requiring annual training is consistent with the proposed 
requirement to annually update a HHAs emergency plan and policies and 
procedures. We believe that it is best practice for facilities to 
ensure that their staff is regularly informed and educated in order to 
be the most prepared during an emergency situation.
    Comment: A few commenters expressed their concern in regard to our 
proposal to require HHAs to participate in a community mock disaster 
drill. The commenters acknowledged the benefits and necessity of 
participating in drills and exercises to determine the effectiveness of 
an agency's plan, but stated that conducting drills and exercises is 
costly, time consuming, and especially difficult for HHAs in remote 
areas. Taking into consideration all of the documentation required for 
HHA patients, multiple commenters requested additional flexibility for 
HHAs, indicating that requiring both an annual tabletop exercise and a 
community drill is outside of the capacity of many agencies, would 
disrupt and compromise patient care, and requested additional 
flexibility for HHAs. A commenter suggested that HHAs be encouraged, 
rather than required, to participate in a community disaster drill. 
Another commenter stated that HHAs in particular would need to employ 
an additional person to be responsible for exercise planning and 
preparation and would also need to stop providing patient care during 
the exercises. The commenter indicated that there is a more cost 
effective and efficient way to ensure a HHA and its staff understand 
their emergency procedures without taking away from patient care and 
adding cost. The commenter suggested that, for HHAs, we should require 
``discussion-based'' exercises leading up to a community mock drill 
required every 5 years.
    Response: We appreciate the feedback from these commenters. As 
discussed, many other providers and suppliers have shared similar 
concerns. Therefore, we have revised Sec.  484.22 to provide that HHAs 
may choose which type of training exercise they want to conduct in 
order to fulfill their second testing requirement. In addition, we 
would encourage agencies to continue looking to their local county and 
state governments and local healthcare coalitions for opportunities to 
collaborate on their training and testing efforts, such as a community 
full-scale exercise.
    After consideration of the comments we received on these proposals, 
and the general comments we received on the proposed rule, as discussed 
in the hospital section (section II.C. of this final rule), we are 
finalizing the proposed emergency preparedness requirements for HHAs 
with the following modifications:
     Revising the introductory text of Sec.  484.22 by adding 
the term ``local'' to clarify that HHAs must also comply with local 
emergency preparedness requirements.
     Revising Sec.  484.22(a)(4) by deleting the term 
``ensuring'' and replacing the term ``ensure'' with ``maintain.''
     Revising Sec.  484.22(b)(3) to require that in the event 
that there is an interruption in services during or due to an 
emergency, HHAs must have policies in place for following up with 
patients to determine services that are still needed. In addition, they 
must inform State and local officials of any on-duty staff or patients 
that they are unable to contact.
     Revising Sec.  484.22(b)(4) to change the phrase ``ensures 
records are secure and readily available'' to ``secures and maintains 
availability of records.''
     Removing Sec.  484.22(b)(6) that required that HHAs 
develop arrangements with other HHAs and other providers to receive 
patients in the event of limitations or cessation of operations to 
ensure the continuity of services to HHA patients.
     Revising Sec.  484.22(c) by adding the term ``local'' to 
clarify that the HHA must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.
     Revising Sec.  484.22(c)(1) to remove the requirement that 
HHAs include the names and contact information for ``Other HHAs'' in 
the communication plan.
     Revising Sec.  484.22(d) by adding that each HHA's 
training and testing program must be based on the HHA's emergency plan, 
risk assessment, policies and procedures, and communication plan.

[[Page 63918]]

     Revising Sec.  484.22(d)(1)(ii) by replacing the phrase 
``Ensure that staff can demonstrate knowledge'' to ``Demonstrate staff 
knowledge.''
     Revising Sec.  484.22(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  484.22(d)(2)(ii) to allow a HHA to choose 
the type of exercise it will conduct to meet the second annual testing 
requirement.
     Adding Sec.  484.22(e) to allow a separately certified HHA 
within a healthcare system to elect to be a part of the healthcare 
system's emergency preparedness program.

M. 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 June 2016, there were 205 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.
    We proposed that CORFs comply with the same requirements that would 
be required for hospitals, with appropriate exceptions.
    Specifically, at Sec.  485.68(a)(5), we proposed that CORFs develop 
and maintain the emergency preparedness plan with assistance from fire, 
safety, and other appropriate experts. We did not propose to require 
CORFs to provide basic subsistence needs for staff and patients as we 
proposed for hospitals at Sec.  482.15(b)(1). Because CORFs are 
outpatient facilities, we did not propose 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.  485.68(b)(1), we proposed to require 
that CORFs have policies and procedures for evacuation from the CORF, 
including staff responsibilities and needs of the patients.
    We did not propose that CORFS have arrangements with other CORFs or 
other providers and suppliers to receive patients in the event of 
limitations or cessation of operations. Finally, we did 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 a proposed requirement similar to that 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, although we are clarifying in this final rule 
that CORFs must establish communications plans that are in compliance 
with federal laws, including the HIPAA rules. 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 proposed 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 
healthcare facilities, as necessary, to ensure continuity of care (see 
proposed Sec.  485.68(c)(4)). At Sec.  485.68(c)(5), we proposed 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 local health department or authority having 
jurisdiction or the Incident Command Center, or designee. We did not 
propose to require 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.
    We proposed to remove Sec.  485.64 and incorporate certain 
requirements into Sec.  485.68. 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 incorporated this requirement at proposed Sec.  
485.68(a)(5). Currently, Sec.  485.64(a)(3) requires that the training 
program include instruction in the location and use of alarm systems 
and signals and firefighting equipment. We incorporated these 
requirements at proposed Sec.  485.68(d)(1).
    We did not receive any comments that specifically addressed the 
proposed rule as it relates to CORFs. However, after consideration of 
the general comments we received on the proposed rule, as discussed in 
the hospital section (section II.C. of this final rule, we are 
finalizing the proposed emergency preparedness requirements for CORFs 
with the following modifications:
     Revising the introductory text of Sec.  485.68, by adding 
the term ``local'' to clarify that CORFs must also comply with local 
emergency preparedness requirements.
     Revising Sec.  485.68(a)(4) by deleting the term 
``ensuring'' and replacing the term ``ensure'' with ``maintain.''
     Revising Sec.  485.68(b)(3) to replace the phrase 
``ensures records are secure and readily available'' to ``secures and 
maintains availability of records.''
     Revising Sec.  485.68(c), by adding the term ``local'' to 
clarify that the CORFs must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.

[[Page 63919]]

     Revising Sec.  485.68(d) by adding that each CORF's 
training and testing program must be based on the CORF's emergency 
plan, risk assessment, policies and procedures, and communication plan.
     Revising Sec.  485.68(d)(1)(iv) to replace the phrase 
``Ensure that staff can demonstrate knowledge'' to ``Demonstrate staff 
knowledge.''
     Revising Sec.  485.68(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  485.68(d)(2)(ii) to allow a CORF to choose 
the type of exercise it will conduct to meet the second annual testing 
requirement.
     Adding Sec.  485.68(e) to allow a separately certified 
CORF within a healthcare system to elect to be a part of the healthcare 
system's emergency preparedness program.

N. 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 June 2016, there are 1,337 CAHs that must meet the CAH 
CoPs and 121 CAHs with psychiatric or rehabilitation distinct part 
units (DPUs). DPUs within CAHs must meet the hospital CoPs in order to 
receive payment for services provided to Medicare or Medicaid patients 
in the DPU.
    CAHs are small, rural, limited-service facilities with low patient 
volume. The intent of designating facilities as ``critical access 
hospitals'' is to ensure access to inpatient hospital services and 
outpatient services, including emergency services, that meet the needs 
of the community.
    If no patients are present, CAHs are not required to have onsite 
clinical staff 24 hours a day. However, a doctor of medicine or 
osteopathy, nurse practitioner, clinical nurse specialist, or physician 
assistant is available to furnish patient care services at all times 
the CAH operates. In addition, there must be a registered nurse, 
licensed practical nurse, or clinical nurse specialist on duty whenever 
the CAH has one or more inpatients. 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 for CAHs that meet certain criteria, within 60 minutes. 
CAHs currently are required to coordinate with emergency response 
systems in the area to establish procedures under which a doctor of 
medicine or osteopathy is immediately available by telephone or radio 
contact on a 24-hours a day basis to receive emergency calls, provide 
information on treatment of emergency patients, and refer patients to 
the CAH or other appropriate locations for treatment.
    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 proposed 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.
    We proposed to relocate current Sec.  485.623(c)(1) to proposed 
Sec.  485.625(d)(1). We proposed 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 of this final rule we 
proposed 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 NFPA[supreg]. In addition to the 
emergency power system inspection and testing requirements found in 
NFPA[supreg] 99 and NFPA[supreg] 110 and NFPA[supreg] 101, we proposed 
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.
    Comment: A few commenters stated that since CAHs play an important 
role in rural communities, an immediate community response in the event 
of an emergency is critical.
    Response: We agree with the commenters and we require CAHs, and all 
providers, to comply with all applicable federal, state, and local 
emergency preparedness requirements. We also encourage CAHs to 
participate in state-wide collaborations where possible.
    Comment: A couple of commenters questioned the ability of CAHs to 
participate in an integrated health system to develop an emergency 
plan. They stated that providers and suppliers were encouraged 
throughout the proposed rule to plan together and with their 
communities to achieve coordinated responses to emergencies.
    Response: As discussed previously in this rule, we agree that CAHs 
should be able to participate in an in integrated health system to 
develop a universal plan that encompasses one community-based risk 
assessment, separate facility-based risk assessments, integrated 
policies and procedures that meet the requirements for each facility, 
and coordinated communication plans, training and testing. Currently, a 
CAH that is a member of a rural health network has an agreement with at 
least one hospital in the network for patient referrals and transfers. 
The proposed requirement for a CAH's emergency preparedness 
communication plan states that the CAH must include contact information 
for other CAHs. However, to be consistent with an integrated approach, 
we have also changed the proposed requirements at Sec.  
485.625(c)(1)(iv) to state that CAHs should develop a communication 
plan that would require them to have contact information for other CAHs 
and hospitals or both.
    We also received a number of comments pertaining to the proposed 
requirements for CAHs, most commenters addressing both hospitals and 
CAHs in their responses. Thus, we responded to the comments under the 
hospital section (section II.C. of this final rule). After 
consideration of the comments we received on the proposed rule, as 
discussed in section II.C of this final rule, we are finalizing the 
proposed emergency preparedness requirements for CAHs with the 
following:

[[Page 63920]]

     Revising the introductory text of Sec.  485.625 by adding 
the term ``local'' to clarify that CAHs must also comply with local 
emergency preparedness requirements.
     Revising Sec.  485.625(a)(4) by deleting the term 
``ensuring'' and replacing the term ``ensure with ``maintain.''
     Adding at Sec.  485.625(b)(1)(i) that CAHs must have 
policies and procedures that address the need to sustain 
pharmaceuticals during an emergency.
     Revising Sec.  485.625(b)(2) to remove the requirement for 
CAHs to track on-duty staff and patients after an emergency and 
clarifying that in the event staff and patients are relocated, the CAH 
must document the specific name and location of the receiving facility 
or other location to which on-duty staff and patients were relocated to 
during an emergency.
     Revising Sec.  485.625(b)(5) to change the phrase 
``ensures records are secure and readily available'' to ``secures and 
maintains availability of records;'' also revising paragraph (b)(7) to 
change the term ``ensure'' to ``maintain''
     Revising Sec.  485.625(c) by adding the term ``local'' to 
clarify that the CAHs must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.
     Revising Sec.  485.625(c)(1)(iv) by adding the phrase 
``and hospitals'' to clarify that a CAH's communication plan must 
include contact information for other CAHs and hospitals in the area.
     Revising Sec.  485.625(c)(5) to clarify that CAHs must 
develop a means, in the event of an evacuation, to release patient 
information, as permitted under 45 CFR 164.510(b)(1)(ii).
     Revising Sec.  485.625(d) by adding that each CAH's 
training and testing program must be based on the CAH's emergency plan, 
risk assessment, policies and procedures, and communication plan.
     Revising Sec.  485.625(d)(1)(iv) to replace the phrase 
``ensure that staff can demonstrate knowledge'' to ``demonstrate staff 
knowledge.''
     Revising Sec.  485.625(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  485.625(d)(2)(ii) to allow a CAH to choose 
the type of exercise it will conduct to meet the second annual testing 
requirement.
     Revising Sec.  485.625(e)(1) and (2) by removing the 
requirement for additional generator testing.
     Revising Sec.  485.625(e)(2)(i) by removing the 
requirement for an additional 4 hours of generator testing and clarify 
that these facilities must meet the requirements of NFPA[supreg] 99 
2012 edition, NFPA[supreg] 101 2012 edition, and NFPA[supreg] 110, 2010 
edition.
     Revising Sec.  485.625(e)(3) by removing the requirement 
that CAHs maintain fuel onsite and clarify that CAHs must have a plan 
to maintain operations unless the CAH evacuates.
     Adding Sec.  485.625(f) to allow a separately certified 
CAH within a healthcare system to elect to be a part of the healthcare 
system's emergency preparedness program.
     Adding Sec.  485.625(g) to incorporate by reference the 
requirements of 2012 NFPA[supreg] 99, 2012 NFPA[supreg] 101, and 2010 
NFPA[supreg] 110.

O. 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. 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 June 2016, there are 2,135 clinics, rehabilitation agencies, 
and public health agencies that provide outpatient physical therapy and 
speech-language pathology services. In the remainder of this proposed 
rule and throughout the requirements, we use the term ``Organizations'' 
instead of ``clinics, rehabilitation agencies, and public health 
agencies as providers of outpatient physical therapy and speech-
language pathology services'' for consistency with current regulatory 
language.
    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 local health department and emergency 
management authority having jurisdiction, or the Incident Command 
Center, or designee. At Sec.  485.727(c)(5), we proposed to require 
that these Organizations 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 did 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 Organizations 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. Those requirements are addressed 
throughout the proposed CoP, and we did 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 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

[[Page 63921]]

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 
proposed to relocate 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 did not propose to 
relocate them but merely to address them in that paragraph. Current 
Sec.  485.727, ``Disaster preparedness,'' would be removed.
    We did not receive any comments that specifically addressed the 
proposed rule as it relates to clinics, rehabilitation agencies, and 
public health agencies as providers of outpatient physical therapy and 
speech-language pathology services. However, after consideration of the 
general comments we received on the proposed rule, as discussed in the 
hospital section (section II.C. of this final rule, we are finalizing 
the proposed emergency preparedness requirements for these 
Organizations with the following modifications:
     Revising the introductory text of Sec.  485.727 by adding 
the term ``local'' to clarify that the Organizations must also comply 
with local emergency preparedness requirements.
     Revising Sec.  485.727(a)(5) by deleting the term 
``ensuring'' and replacing the term ``ensure'' with ``maintain.''
     Revising Sec.  485.727(b)(3) to change the phrase 
``ensures records are secure and readily available'' to ``secures and 
maintains availability of records.''
     Revising Sec.  485.727(c), by adding the term ``local'' to 
clarify that the Organizations must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.
     Revising Sec.  485.727(d) by adding that the 
Organization's training and testing program must be based on the 
organization's emergency plan, risk assessment, policies and 
procedures, and communication plan.
     Revising Sec.  485.727(d)(1)(iv) to replace the phrase 
``ensure that staff can demonstrate knowledge'' to ``demonstrate staff 
knowledge.''
     Revising Sec.  485.727(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  485.727(d)(2)(ii) to allow an Organization 
to choose the type of exercise it will conduct to meet the second 
annual testing requirement.
     Adding Sec.  485.727(e) to allow a separately certified 
Organizations within a healthcare system to elect to be a part of the 
healthcare system's emergency preparedness program.

P. 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 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 
2015 there were 362 Medicare-certified CMHCs.
    We proposed that CMHCs meet the same emergency preparedness 
requirements we proposed for hospitals, with a few exceptions. At Sec.  
485.920(c)(7), we proposed to require CMHCs to have a communication 
plan that include a means of providing information about the CMHCs' 
needs and their ability to provide assistance to the local health 
department or emergency management authority having jurisdiction or the 
Incident Command Center, or designee.
    We did not receive any comments that specifically addressed the 
proposed rule as it relates to CMHCs. However, after consideration of 
the general comments we received on the proposed rule, as discussed in 
the hospital section (section II.C. of this final rule), we are 
finalizing the proposed emergency preparedness requirements for CMHCs 
with the following modifications:
     Revising the introductory text of Sec.  485.920 by adding 
the term ``local'' to clarify that CMHCs must also comply with local 
emergency preparedness requirements.
     Revising Sec.  485.920(a)(4) by deleting the term 
``ensuring'' and replacing the term ``ensure'' with ``maintain.''
     Revising Sec.  485.920(b)(1) by clarifying that tracking 
during and after the emergency applies to on-duty staff and sheltered 
clients. We have also revised paragraph (b)(1) to provide that if on-
duty staff and sheltered clients are relocated during the emergency, 
the facility must document the specific name and location of the 
receiving facility or other location.
     Revising Sec.  485.920(b)(4) and (6) to change the phrase 
``ensures records are secure and readily available'' to ``secures and 
maintains availability of records.'' Also, we made changes in paragraph 
(b)(6) to replace the term ``ensure'' to ``maintain.''
     Revising Sec.  485.920(c) by adding the term ``local'' to 
clarify that CMHCs must develop and maintain an emergency preparedness 
communication plan that also complies with local laws.
     Revising Sec.  485.920(c)(5) to clarify that CMHCs must 
develop a means, in the event of an evacuation, to release patient 
information, as permitted under 45 CFR 164.510(b)(1)(ii).
     Revising Sec.  485.920(d) by adding that each CMHC's 
training and testing program must be based on the CMHC's emergency 
plan, risk assessment, policies and procedures, and communication plan.
     Revising Sec.  485.920(d)(1) to replace the phrase 
``ensure that staff can demonstrate knowledge'' to ``demonstrate staff 
knowledge.''
     Revising Sec.  485.920(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  485.920(d)(2)(ii) to allow a CMHC to choose 
the type of exercise it will conduct to meet the second annual testing 
requirement.
     Adding Sec.  485.920(e) to allow a separately certified 
CMHC within a healthcare system to elect to be a part of the healthcare 
systems emergency preparedness program.

Q. 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

[[Page 63922]]

requirements. As of June 2016, there were 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. Our proposed requirements for OPOs to 
develop and maintain an emergency preparedness plan, were similar to 
those proposed for hospitals, with some exceptions.
    Since potential donors 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 proposed 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.
    We proposed only 2 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.
    In addition, at Sec.  486.360(c), we proposed only three 
requirements for an OPO's communication plan. An OPO's communication 
plan would be required to 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 
health department and 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. Unlike the requirement we proposed for hospitals 
at Sec.  482.15(d)(2)(i) and (iii), we proposed at Sec.  
486.360(d)(2)(i) that an OPO be required only to conduct a tabletop 
exercise.
    Finally, at Sec.  486.360(e), we proposed 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 
proposed 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.
    Comment: We proposed the OPOs should track their staff during and 
after an emergency. All of the comments we received regarding this 
requirement were supportive. Commenters requested that we clarify 
whether an electronic system will satisfy this requirement. Commenters 
indicated that many OPOs currently have a means to communicate with all 
staff electronically and request that they respond with their location 
(within an identified time period) if necessary. Commenters questioned 
whether this process would be sufficient to meet this requirement.
    Response: We appreciate the commenters' feedback and agree that the 
means of communication described by commenters is sufficient to meet 
this requirement. However, we want to emphasize that this is not the 
only way OPOs may choose to meet this requirement. In the proposed 
rule, we indicated that OPOs have the flexibility to determine how best 
to track staff whether an electronic database, hard copy documentation, 
or some other method.
    Comment: A few commenters agreed with the proposal that would 
require that communication plans include names and contact information 
for staff, entities providing services under arrangement, volunteers, 
other OPOs, and transplant and donor hospitals in the OPO's DSA. 
However, the commenters requested that CMS narrow the requirements for 
OPOs to include only individuals or entities providing services under 
arrangement to those entities that would provide services in or during 
an emergency situation, such as emergency contacts for building 
services (plumbing, electrical, etc.), transportation providers, 
laboratory testing, etc.
    Another commenter also agreed with the importance of providing a 
communication plan with staff information, but disagreed with the 
requirement that all entities providing services under arrangement with 
an OPO should be contacted during an emergency. The commenter 
recommended that only vendors providing critical services be contacted.
    Response: We are requiring that OPOs provide in their communication 
plan the names and contact information for staff, entities providing 
services under arrangement, volunteers, other OPOs, and transplant and 
donor hospitals in the OPO's DSA. We are also requiring that OPOs 
include the contact information for federal, state, tribal, regional, 
and local emergency preparedness staff. Facilities can choose to 
include the contact information of other entities in their 
communication plan; however, we are not narrowing the scope of our 
requirements in this section to only include those entities with which 
an OPO has an arrangement. We continue to believe that it is important 
that OPOs have contact information for all of the previously specified 
entities because the OPO cannot know before an emergency what entities 
or services it would need. Also, we do not believe that it is 
burdensome for OPOs to maintain contact information for these entities 
because we believe that maintenance of contact information for these 
various entities is part of the normal course of business.
    Comment: Several commenters requested clarification on whether 
existing databases of contact information would satisfy the 
communication plan requirements. The commenters listed examples such as 
a hosted volunteer tracking system or UNOS' DonorNET, with external 
backups.
    Response: Each OPO should develop and maintain its own separate 
contact list in order to satisfy the communication plan requirements. 
OPOs must include contact information for staff, entities providing 
services under arrangement, volunteers, other OPOs, transplant and 
donor hospitals in the OPO's DSA and federal, state, tribal, regional, 
and local emergency preparedness staff, and other sources of 
assistance. DonorNET and other hosted volunteer tracking systems may 
contain useful contact information that OPO providers can use during an 
emergency, but these systems do not replace the need for comprehensive 
contact lists in the provider's emergency preparedness communication 
plan.
    Comment: In regard to our proposed requirements for OPOs to have 
training and testing programs, all the commenters agreed with our 
proposals, but requested clarification of the phrase ``consistent with 
their expected roles.'' The commenters questioned whether this meant 
that an OPO is not required to perform emergency preparedness training 
to staff, vendors, and volunteers who are not expected to play a role 
in the OPOs emergency response.
    Response: This final rule requires that all persons (those 
employed, contracted, or volunteering) who provide some service within 
an OPO must be trained on the OPOs emergency preparedness procedures, 
given that an emergency can take place at any time. All providers and 
suppliers types have the flexibility to determine the level of training 
that is

[[Page 63923]]

need for each staff person. As the requirement states for OPOs, this 
level of training should be determined consistent with the persons 
expected role during an emergency. It does not eliminate the need for 
all persons to be trained; however, an OPO has the discretion to 
determine to what extent.
    Comment: Most of the commenters did not agree with the proposed 
requirement that each OPO have an agreement with one or more other 
OPOs. These commenters stated that the requirement was unnecessary and 
too burdensome. They indicated that our estimate of 13 burden hours was 
extremely conservative and that possibly as many as 200 contracts would 
need to be modified to comply with the requirements in proposed Sec.  
486.360(e).
    Response: We agree with the commenters. The majority of the 
commenters indicated that complying with this requirement would require 
much more than the estimated 13 burden hours. In reviewing their 
comments and our estimate, we believe that the requirement for an 
agreement with one or more OPOs should be modified. Based upon our 
analysis and comments submitted in response to the proposed rule, we 
have inserted alternate ways in which an OPO could plan to continue its 
operations. See Sec.  486.360(e). See section III.O. of this final rule 
Collection of Information Requirements, ICRs Regarding Condition for 
Coverage: Emergency Preparedness (Sec.  486.360), for our current 
burden estimate.
    We disagree with the commenters that the requirement for OPOs to 
have an agreement with another OPO is unnecessary. We believe each OPO 
should be prepared to continue its operations or at least those 
activities it deems essential during an emergency as required by Sec.  
486.360(e). However, as discussed later in this final rule, based on 
the comments we received, we have decided to provide alternate ways in 
which OPOs could satisfy this requirement, which are discussed as 
follows:
    Comment: A commenter noted the difficulty in developing an 
emergency plan based upon the all-hazards approach. One OPO works with 
more than 170 hospitals. Each hospital had its own specific levels of 
service and donor potential. These hospitals also had different 
geographically-based hazards. All of these factors would need to be 
addressed or taken into account when developing an emergency program.
    Response: The amount of resources that each OPO must expend to 
comply with the requirements in this final rule will vary depending 
upon many factors. The number of hospitals the OPO works with, the 
services that each hospital offers, and the geographical hazards for 
each of these hospitals are all factors that could affect how complex 
the emergency plan and program would need to be. And, all of these 
various factors would need to be addressed in the OPO's emergency plan. 
We realize developing emergency plans and programs can be challenging; 
however, since OPOs are already working with these hospitals and there 
are a wide-range of emergency planning tools available, as well as 
assistance from the OPTN and other organizations, we believe that OPOs 
will be able to develop their emergency preparedness plans and programs 
within the burden estimates we have developed.
    Comment: As discussed earlier with transplant centers, several 
commenters expressed concerned about how the proposed OPO requirements 
could interfere with or even contradict OPTN policies on emergencies; 
the commenter specifically referenced OPTN 1.4 that addresses regional 
and national emergencies. Among other things, this policy requires OPTN 
members to notify the OPTN concerning any alternative arrangements of 
care during an emergency and provide additional information as needed 
to allow for clinical information to be properly accessed and shared 
with all parties involved in a donation or transplant event.
    Response: We disagree with the commenters. We do not expect any OPO 
to violate any of the OPTN's policies. However, as stated earlier, the 
OPTN's policies are not comprehensive. For example, they do not cover 
local emergencies or the other specific requirement in this final rule, 
that is, requirements for a risk assessment using an all-hazards 
approach, an emergency plan, specific policies and procedures, a 
communication plan, and training and testing. In addition, as described 
earlier, including emergency preparedness requirements in the OPO CfCs 
provides us with oversight and enforcement authority we do not have for 
the OPTN policies. In addition, we do not believe that complying with 
any of the requirements in this final rule will result in any conflict 
with the OPTN's requirements.
    Comment: Some commenters questioned whether OPOs that already had 
more than one location or office needed to have an agreement with 
another OPO to provide essential organ procurement services to all or a 
portion of their DSA in the event of an emergency. A commenter 
questioned if we had considered this as an alternative to the proposed 
agreement.
    Response: We did not propose having multiple locations as an 
alternative to the proposed requirement to have an agreement with 
another OPO. However, as the commenters suggested, we do believe that 
having more than one location could certainly satisfy our concern that 
OPOs have the capability to continue their organ procurement 
responsibilities in the event of an emergency. Therefore, in finalizing 
this requirement, we have added two alternatives to the requirement for 
an OPO to have an agreement with another OPO (Sec.  486.360(e)). For 
OPOs with multiple locations, the OPO could satisfy this requirement if 
it had an alternate location within its DSA from which it could 
continue its operation during an emergency. Another alternative is if 
the OPO had a plan to relocate to an alternate location that is part of 
its emergency plan as required in Sec.  486.360(a). If the emergency 
were to affect an area larger than the OPO's DSA, we would expect that 
the OPTN would assist the OPO (OPTN Policy 4.1).
    Comment: Some commenters suggested that instead of having formal 
agreements, OPOs, transplant centers, and hospitals should be required 
to develop mutually agreed-upon protocols that address each facility's 
responsibilities during an emergency.
    Response: We agree with the commenters. After reviewing the 
comments we received on the proposed transplant center and OPO 
emergency preparedness requirements, we believe that the best way to 
ensure that transplant centers, the hospitals in which they operate, 
and the OPOs are prepared for emergencies is to require the development 
of mutually agreed-upon protocols that address the hospital, transplant 
center, and OPO's duties and responsibilities during an emergency. 
Therefore, we have removed the requirements in proposed Sec.  
482.78(a), which required an agreement with at least one Medicare-
approved transplant center, and Sec.  482.78(b), which required that 
the transplant center ensure that the written agreement required under 
Sec.  482.100 addresses the duties and responsibilities of the hospital 
and OPO during an emergency. Instead, we have finalized a requirement 
at Sec.  486.360(e) that OPOs develop mutually-agreed upon protocols 
that address the duties and responsibilities of the hospital, 
transplant center, and OPO during emergencies. We are also requiring 
that transplant centers and the hospitals in which they operate develop 
mutually-

[[Page 63924]]

agreed upon protocols. Therefore, all 3 facilities will need to work 
together to develop and maintain protocols that address emergency 
preparedness.
    Comment: A commenter recommended that CMS revise language in the 
manual to cover the costs of transportation of brain-dead donors for 
organ procurement. Furthermore, the commenter recommended that 
transplant centers be permitted to record organs from brain-dead donors 
sent to OPO recovery centers in the ratio of Medicare usable organs to 
total organs on their costs reports. The commenter noted that this 
would facilitate implementation of the proposed emergency preparedness 
requirements.
    Response: We believe it is extremely unlikely that brain-dead 
donors would need to be transported during an emergency. Most OPOs are 
not recovering brain-dead donors every day and might or might not 
choose to move a potential donor depending upon the donor's condition. 
However, we would encourage transplant centers, the hospitals in which 
they are located, and OPOs to address this possibility in their 
emergency preparedness protocols as finalized in this rule. In 
addition, the commenter's request involves changes to the state 
operations manual and Medicare's policy on cost reports. These are 
payment policy issues and are outside of the scope of this regulation.
    After consideration of the comments we received on these 
provisions, and the general comments we received on the proposed rule, 
as discussed in the hospital section (section II.C. of this final rule, 
we are finalizing the proposed emergency preparedness requirements for 
OPOs with the following modifications:
     Revising the introductory text of Sec.  486.360 by adding 
the term ``local'' to clarify that OPOs must also comply with local 
emergency preparedness requirements.
     Revising Sec.  486.360(a)(4) by deleting the term 
``ensuring'' and replacing the term ``ensure'' with ``maintain.''
     Revising Sec.  486.360(b)(1) by clarifying that tracking 
during and after the emergency applies to on-duty staff and any staff 
that are relocated during an emergency. Also, we revised paragraph 
(b)(1) to provide that if on-duty staff are relocated during the 
emergency, the facility must document the specific name and location of 
the receiving facility or other location.
     Revising Sec.  486.360(b)(2) to change the phrase 
``ensures records are secure and readily available'' to secures and 
maintains availability of records.''
     Revising Sec.  486.360(c) by adding the term ``local'' to 
clarify that the OPO must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.
     Revising Sec.  486.360(d) by adding that each OPO's 
training and testing program must be based on the OPO's emergency plan, 
risk assessment using an all hazards approach, policies and procedures, 
and communication plan.
     Revising Sec.  486.360(d)(1)(iv) to replace the phrase 
``ensure that staff can demonstrate knowledge'' to ``demonstrate staff 
knowledge.''
     Revising the requirement in Sec.  486.360(e) to require 
the development and maintenance of emergency preparedness protocols 
that are mutually agreed upon by the transplant center, hospital, and 
OPO.
     Revising Sec.  486.360(e) to state that OPOs can satisfy 
the agreement requirement by having at least one other location from 
which they could operate from within their DSA or a plan to set up an 
alternate location during an emergency as part of its emergency plan as 
required by Sec.  486.360(a).
     Adding Sec.  486.360(f) to allow a separately certified 
OPO within a healthcare system to elect to be a part of the healthcare 
system's emergency preparedness program.

R. Emergency Preparedness Regulations for Rural Health Clinics (RHCs) 
and Federally Qualified Health Centers (FQHCs) (Sec.  491.12)

    As of June 2016, there were a combined total of 11,500 RHCs and 
FQHCs. Section 1861(aa) of the Act sets forth the rural health clinic 
(RHC) and federally qualified health center (FQHC) services covered by 
the Medicare and Medicaid program. RHCs must be located in an area that 
is both a rural area and a designated shortage area.
    Conditions for Certification for RHCs and Conditions for Coverage 
for FQHCs are found at 42 CFR part 491, subpart A. Current emergency 
preparedness requirements are found at Sec.  491.6(c).
    We proposed that the RHCs' and FQHCs' emergency preparedness plans 
address the type of services the facility has the capacity to provide 
in an emergency.
    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 
CfC 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 proposed emergency preparedness requirements based on the 
requirements that we proposed for hospitals, modified to address the 
specific characteristics of RHCs and FQHCs. We do not believe all of 
these requirements are appropriate for RHCs/FQHCs, which serve only 
outpatients. We did 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 did not propose 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 proposed 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. Therefore, at Sec.  491.12(b)(1), we 
proposed 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 was proposed for hospitals at Sec.  
482.15(b)(7), we did not propose that RHCs/FQHCs have arrangements with 
other RHCs/FQHCs or other providers and suppliers to receive patients 
in the event of limitations or cessation of operations to ensure the 
continuity of services to RHC/FQHC patients. We did 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

[[Page 63925]]

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 proposed 
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 local health department or 
emergency management authority having jurisdiction or the Incident 
Command Center, or designee. We did not propose to require 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.
    Comment: A commenter supported CMS' proposal to exempt FQHCs from 
releasing patient information as permitted under HIPAA 45 CFR part 164 
in the case of an emergency or disaster.
    Another commenter opposed CMS' proposed requirements for a 
communication plan for RHCs and FQHCs. The commenter stated their 
belief that RHCs and FQHCs should provide some level of patient 
clinical information during a disaster. The commenter noted the 
importance of sharing patient information with other hospitals that may 
be receiving evacuated patients during an emergency or a disaster. 
Furthermore, the commenter noted that these records should be available 
online through an EMR or through another procedure for providing 
patient information.
    Response: We appreciate the commenter's support. We continue to 
believe that RHCs and FQHCs should not be required to comply with the 
proposed requirement for hospitals, 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. RHCs and FQHCs are not 
inpatient facilities that would transfer patients to another facility 
during an evacuation. Because they operate on an outpatient basis, 
whereby during an emergency the facility would close and cancel 
appointments, we do not believe that it is necessary for RHCs and FQHCs 
to be mandated to provide patient information during an evacuation. 
However, we note that RHCs and FQHCs are not precluded from including 
policies and procedures in their communication plan to share patient 
information during an emergency with other facilities. RHCs and FQHCs 
can include these policies and procedures if they believe it is 
appropriate for their facility.
    Comment: A commenter stated that small facilities such as an FQHC 
or RHC should be exempt from conducting a risk assessment. Another 
commenter stated that clinics should be required to have a plan to 
utilize volunteers in an emergency.
    Response: We disagree with removing the risk assessment requirement 
for FQHCs and RHC. As we have stated earlier in this document, 
conducting a risk assessment is essential to developing an emergency 
preparedness plan. Clinics will have the flexibility to include 
volunteers in their emergency plan as indicated by their individual 
risk assessments. We would expect RHCs and FQHCs to develop strategies 
for addressing emergency events identified by their risk assessments.
    After consideration of the comments we received on these 
provisions, and the general comments we received on the proposed rule, 
as discussed previously and in the hospital section (section II.C. of 
this final rule, we are finalizing the proposed emergency preparedness 
requirements for RHCs and FQHCs with the following modifications:
     Revising the introductory text of Sec.  491.12 by adding 
the term ``local'' to clarify that RHCs and FQHCs must also coordinate 
with local emergency preparedness requirements.
     Revising Sec.  491.12(a)(4) by deleting the term 
``ensuring'' and replacing the term ``ensure'' with ``maintain.''
     Revising Sec.  491.12(b)(3) to change the phrase ``ensures 
records are secure and readily available'' to ``secures and maintains 
availability of records.''
     Revising Sec.  491.12(c) by adding the term ``local'' to 
clarify that RHCs and FQHCs must develop and maintain an emergency 
preparedness communication plan that also complies with local laws.
     Revising Sec.  491.12(d) by adding that a RHC and FQHC's 
training and testing program must be based on the RHC and FQHC's 
emergency plan, risk assessment, policies and procedures, and 
communication plan.
     Revising Sec.  491.12(d)(1)(iv) to replace the phrase 
``ensure that staff can demonstrate knowledge'' to ``demonstrate staff 
knowledge.''
     Revising Sec.  491.12(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  491.12(d)(2)(ii) to allow a RHC and FQHC to 
choose the type of exercise it will conduct to meet the second annual 
testing requirement.
     Adding Sec.  491.12(e) to allow separately certified RHCs 
and FQHCs within a healthcare system to elect to be a part of the 
healthcare system's emergency preparedness program.

S. 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. As of June 2016, there were 6,648 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) titled, 
``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 proposed 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 did 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 proposed for 
hospitals at Sec.  482.15(b)(1).
    At Sec.  494.62(b), we proposed to require facilities to address in 
their policies and procedures, fire, equipment or power failures, care-
related emergencies, water

[[Page 63926]]

supply interruption, and natural disasters in the facility's geographic 
area.
    At Sec.  482.15(b)(3), we proposed 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 proposed to require 
that ESRD facilities have policies and procedures for evacuation from 
the facility, including staff responsibilities and needs of the 
patients.
    At Sec.  494.62(b)(6), we proposed to require ESRD facilities to 
develop arrangements with other dialysis facilities or other providers 
and suppliers to receive patients in the event of limitations or 
cessation of operations to ensure the continuity of services to 
dialysis facility patients. 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 
proposed 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 did 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 proposed 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; and whom to contact if an 
emergency occurs while the patient is not in the dialysis facility.
    We proposed to 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.
    We proposed to redesignate current Sec.  494.60(d). Current 
requirements for emergency plans at Sec.  494.60 were 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 proposed to relocate existing 
requirements for emergency equipment and emergency drugs found at 
existing Sec.  494.60(d)(3) to Sec.  494.62(b)(9). We proposed to 
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 proposed to 
relocate the current requirements at Sec.  494.60(d)(4)(iii) for 
contacting the local health department and 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 also proposed to redesignate the current Sec.  
494.60(e) as Sec.  494.60(d).
    Comment: Some commenters agreed with the proposal to require ESRD 
providers to develop and maintain an emergency preparedness 
communication plan. Several commenters disagreed with the 
implementation of the emergency preparedness communication plan 
requirements for dialysis facilities. A commenter noted that the 
current CfCs require dialysis facilities to have at least annual 
contact with the local disaster management agency.
    A commenter agreed with the proposal that exempts ESRD facilities 
from having to provide information regarding occupancy since, according 
to the commenter, the facilities do not serve outpatient and do not 
routinely accommodate overnight stays.
    Response: We appreciate the commenters' support. We continue to 
believe that ESRD facilities should develop and maintain a 
communication plan so that the facility can be prepared to communicate 
with the local health department, emergency management and other 
emergency preparedness officials during an emergency or a disaster. We 
are not requiring dialysis facilities to provide information regarding 
their occupancy, as we are requiring for hospitals, since the term 
occupancy refers to bed occupancy in an inpatient facility.
    Comment: A commenter stated that the language used in this section 
was vague and erroneously technical. This commenter specifically noted 
that the term ``community mock disaster drill'' in Sec.  
494.62(d)(2)(i) was not consistent with the terminology used in the 
document, Homeland Security Exercise and Evaluation Program 
Terminology, Methodology, and Compliance Guidelines (HSEEP). The term 
``Incident Command Center'' in Sec.  494.62(c)(7) is not an Incident 
Command System (ICS) or National Incident Management System (NIMS) 
term.
    Response: We understand that the commenter is concerned with this 
rule's inconsistencies with terminology used in the disaster and 
emergency response planning community. Providers and suppliers use 
various terms to refer to the same function and we have used the term 
``Incident Command Center'' in this rule to mean ``Operations Center'' 
or ``Incident Command Post.'' After this final rule is published, 
interpretive guidance will be published by CMS that will provide 
additional clarification.
    Comment: A few commenters indicated their support for requiring 
ESRD facilities to develop training and testing programs. The 
commenters stated that given the often medically fragile population 
that ESRD facilities serve and the risk of service disruption during an 
emergency, it would be beneficial for these facilities to train their 
staff and educate their patients regarding steps they can take to 
prepare themselves for emergency situations. A commenter expressed 
support while also reiterating that existing requirements for ESRD 
facilities require staff to be trained in emergency procedures. A 
commenter also expressed their support for allowing ESRD facilities to 
initiate a facility based mock drill in the absence of a community 
drill since participation in a community disaster drill has been 
difficult at times.
    Response: We thank these commenters for their support and agree 
that emergency preparedness training and testing will benefit not only 
the staff of the ESRD facilities, but will also have a positive impact 
on the patients that they serve. We also encourage ESRD facilities to 
be proactive on preparing for emergencies. For example, it is essential 
that dialysis patients and their caregivers have all of their essential 
documentation, such as their doctor's orders or scripts, medical 
history, etc.
    Comment: A commenter noted that with advance notice many dialysis 
patients can evacuate and find shelter with families and friends. 
However, they many have difficulty getting to another dialysis facility 
due to problems with transportation. The commenter did acknowledge that 
providing or arranging for transportation is beyond the scope of 
individual dialysis facilities, but they believed it should be 
addressed at a regional level.

[[Page 63927]]

    Response: We agree with the commenter that transportation may be a 
problem for some dialysis patients that need to evacuate and that 
arranging for transportation in other areas is beyond the scope of 
responsibility for individual dialysis facilities. However, these 
facilities are required to provide emergency preparedness patient 
training, which includes instructions on what to do if the geographic 
area in which the dialysis facility is located must be evacuated (Sec.  
494.62(d)(3)). We expect that instructions on who to contact for 
assistance would be included in that training.
    Comment: Some commenters questioned our proposed requirement for 
policies and procedures that address having a process by which the 
staff could confirm that emergency equipment, including emergency 
drugs, were on the premises at all times and immediately available 
(Sec.  494.62(b)(9)). A commenter stated that this requirement concerns 
clinical practice policies that are outside the purview of emergency 
preparedness. They noted that while the needs of an individual patient 
in an emergency may require that the facility enact it emergency 
response plans, that the needs of an individual patient would not 
require the activation of the facility's emergency preparedness plan. 
Another commenter questioned if we would be providing a list of 
emergency drugs and specifying the quantities of those drugs that the 
dialysis facility would be expected to have at their facility.
    Response: We disagree with commenter on this requirement being 
beyond the scope of this regulation. We are not attempting to regulate 
clinical practice. This section only requires that the staff have a 
process to ensure that emergency equipment is on the premises and 
available during an emergency. While we have listed some basic 
emergency equipment that should be available during any care-related 
emergency, it is the facility's responsibility to determine what 
emergency equipment it needs to have available. In addition, dialysis 
facilities need to be able to manage care-related emergencies during an 
emergency when other assistance, such as EMTs and ambulances, may not 
be immediately available to them. This final rule does not contain any 
specific list of emergency drugs or specify any quantities of drugs to 
have at a facility. That is beyond the scope of this rule. After this 
rule is finalized, there may be additional sub-regulatory guidance 
concerning this requirement.
    Comment: Some commenters requested clarification on the requirement 
about having policies and procedures that address 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 (Sec.  494.62(b)(7)). A commenter inquired about nurses using 
protocols and what was CMS guidance on this. Another commenter thought 
that the requirement was vague and stated that further guidance was 
needed. This commenter noted that providers may request waivers and 
that facilities were unlikely to have a policy beyond either the 
facility's statement that they would comply with the waiver or a 
procedure on how to request a waiver.
    Response: We believe that these issues are more appropriately 
addressed in sub-regulatory guidance. After this final rule is 
published, further guidance will be provided on how facilities should 
comply with this requirement.
    Comment: A commenter suggested revising our proposed requirement 
for dialysis facilities to have policies and procedures that address 
``(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 maintain the continuity of services to 
dialysis facility patients.'' That commenter suggested modifying the 
language to read ``multiple prearrangements with other dialysis 
facilities . . .''
    Response: We disagree with the commenter. The proposed requirement 
uses the plural, ``arrangements.'' We believe that clearly indicates 
that dialysis facilities are expected to have more than one arrangement 
with other facilities to maintain continuity of services to their 
patients. Thus, we will be finalizing the requirement as proposed.
    Comment: A commenter suggested that dialysis facilities, as well as 
other providers, have a requirement to use volunteer management 
registries. Another commenter was supportive of ESRD facilities using 
the Medical Reserve Corps (MRC) and the Emergency System for Advance 
Registration of Volunteer Health Professional (ESAR-VHP) as discussed 
in the hospital section of the proposed rule (78 FR 79097).
    Response: We are finalizing the requirement that is set forth in 
Sec.  494.62(b)(5) that dialysis facilities have policies and 
procedures that address the use of volunteers in an emergency or other 
emergency staffing strategies, including a process and role for 
integration of state and federally designated healthcare professionals 
to address surge needs during an emergency. We believe that each 
facility needs the flexibility to determine how they should use 
volunteers during an emergency. If the facility is located in a state 
where there is a volunteer registry, that is certainly a valuable 
resource for any healthcare facility and we would encourage the use of 
that registry. However, we do not believe that this should be a 
requirement in this final rule. We also agree with the other commenter 
and encourage dialysis facilities to utilize assistance from the MRC 
and ESAR-VHP.
    Comment: Some commenters noted that we did not require dialysis 
facilities to provide basic subsistence needs for their staff and 
patients during an emergency. A commenter agreed with not requiring the 
provision of subsistence needs. However, another commenter requested 
clarification on why this was not a requirement for dialysis facilities 
and recommended requiring subsistence need for at least a short period 
of time.
    Response: We continue to believe that it is not appropriate to 
require that dialysis facilities provide subsistence needs for either 
their staff or patients. Based on our experience with dialysis 
facilities, we expect that most facilities would discharge any patients 
in their facility as soon as possible if they are unable to provide 
services. Therefore, requiring subsistence needs should not be 
necessary. However, we want to emphasize that the requirements in this 
final rule are the minimum requirements that dialysis facilities must 
meet to participate in the Medicare program. Every facility must 
develop and maintain its own emergency plan based on its risk 
assessment as required by Sec.  494.62(a). Based on their risk 
assessment, any dialysis facility could decide that it should provide 
subsistence needs and for what duration.
    Comment: A commenter noted that implementing the requirement for a 
dialysis facility to track staff and patients during and after an 
emergency include routine calls with the Kidney Community Emergency 
Response (KCER). KCER is a part of the Network Coordinating Center 
(NCC) that works with all 18 of the ESRD networks. KCER is the leading 
authority on emergency preparedness and response for the ESRD Network 
community with leadership and management delegated to the KCER staff 
under authority and direction of CMS.
    Response: We agree with the commenter that KCER is an essential 
resource for the ESRD community. We

[[Page 63928]]

recommend that dialysis facilities utilize this resource in their 
emergency preparedness activities. However, we believe that any 
specific requirements concerning communications in the ESRD community 
should be established in sub-regulatory guidance.
    Comment: Concerning our proposed requirement for dialysis 
facilities to have policies and procedures for a system to track the 
location of staff and patients in the dialysis facility's care both 
during and after the emergency, a commenter stated that it would be 
reasonable for CMS to propose specific technology standards to make 
compatibility with electronic medical records (EMR) systems a reality. 
The commenter noted that reliance on print records is tenuous at best 
and this is associated with quick onset of an emergency.
    Response: We acknowledge that EMRs would be very helpful in 
transitions in care and in locating patients. However, the specific 
technology standards for an EMR system suggested by the commenter are 
beyond the scope of this final rule.
    Comment: A commenter believed that there was a contradiction 
between the preamble language (``[w]e 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 . . . (78 FR 79116)) and the requirement in proposed 
Sec.  494.62(b)(3). The proposed section required dialysis facilities 
to have policies and procedures that addressed a means to shelter in 
place for patients, staff, and volunteers who remain in the facility. 
The commenter recommended that we provide further clarity and guidance 
on what is expected in the rule.
    Response: We apologize for any confusion. However, in the language 
cited by the commenter, we were stating that we were not proposing any 
requirement related to subsistence needs associated with evacuation or 
sheltering in place, not that we were not proposing a requirement for 
the dialysis facility to have policies and procedures that address 
sheltering in place. We are finalizing Sec.  494.62(b)(3) as proposed.
    Comment: A commenter disapproved of allowing a one-year exemption 
from the requirement for a full-scale exercise if the facility 
experienced an actual emergency that required activation of their 
emergency plan. The commenter noted that appropriate and frequent 
activation are key to an emergency management plan success and that 
early but unnecessary plan activation is better than a needed but 
future activation. The best training tool for familiarizing the 
leadership and staff in emergency procedures is through experiencing 
actual plan activation.
    Response: We agree that emergency plans must be activated for staff 
and the leadership to both get experience with the emergency procedures 
and test the plan. For that reason, we are finalizing the requirements 
for training and testing the emergency plan. However, we also believe 
that any facility that has had to activate their plan due to an actual 
emergency meets the requirements in this final rule and requiring 
another full-scale drill would be burdensome. Therefore, we are 
finalizing the exemption contained in Sec.  494.62(d)(2)(i) as 
proposed.
    Comment: A commenter wanted more specificity concerning the federal 
law(s) that dialysis facilities would be required to comply with in 
accordance with proposed Sec.  494.62(c). The commenter wanted us to 
specifically state the federal law(s) to which the dialysis facilities 
would need to comply.
    Response: Federal laws, as well as state and local laws, can be 
modified by the appropriate legislative bodies and executives at any 
time. In addition, dialysis facilities are already required to comply 
with the applicable federal, state, and local laws and regulations that 
pertain to both their licensure and any other relevant health and 
safety requirements (Sec.  494.20). Since the requirements we are 
finalizing are in the dialysis facilities' CfC, these facilities must 
already comply with all of the applicable federal, state, and local law 
and regulation concerning their licensure and health and safety 
standards and are responsible for knowing those laws and regulations. 
Thus, we are finalizing Sec.  494.62(c) as proposed.
    Comment: A commenter noted that we, as well as other HHS documents, 
suggest utilizing healthcare coalitions and that more descriptive 
terminology would be necessary to indicated at what level facilities 
and the Networks should be expected to act with emergency management at 
all of those levels.
    Response: Commenting on other HHS documents is beyond the scope of 
this final rule. We have encouraged the providers and suppliers covered 
by this final rule to form and work with healthcare coalitions or both. 
However, that would be their choice, it is not required. In addition, 
since coalitions may be organized in different ways, it would be 
difficult to provide specific requirements on how providers and 
suppliers are to interact with them. Therefore, we do not believe it is 
appropriate to provide specific guidance or requirements on how 
dialysis facilities are to interact with coalitions.
    Comment: A commenter believed that dialysis facilities and the ESRD 
Networks should be provided funding for the equipment that would be 
needed to comply with the requirement for a communication plan (Sec.  
494.62(c)). The commenter specifically proposed funding for cellular 
devices and satellite communications technology for the ESRD Networks 
and GETS/WPS to ensure communications between providers and emergency 
management resources providing direction during emergencies.
    Response: This rule finalizes the emergency preparedness 
requirements for dialysis facilities in Sec.  494.62 of the ESRD CfCs. 
Dialysis facilities must comply with all of their CfCs to be certified 
by Medicare and must do so within the payments they received from 
Medicare.
    Comment: A commenter notes that the proposed rule allowed for an 
exemption from an exercise after plan activation (proposed Sec.  
494.62(d)(2)). They recommended that it would be necessary for at least 
one component of the emergency plan specify what action(s) constitute 
activation of the plan.
    Response: We agree with the commenter. Although it is not a 
specifically required component of the emergency plan, we do believe 
that each plan should indicate under what circumstances it would be 
deemed to be activated.
    Comment: A commenter stated that we had erroneously attributed some 
type of collective authority and emergency assistance ability to the 
ESRD Networks. These are administrative governing bodies and liaisons 
with the federal government. They stated that the increased 
responsibilities imposed on the dialysis facilities by this rule would 
result in confusion within the ESRD community.
    Response: We understand the commenter's concerns. However, we will 
be providing further sub-regulatory guidance after publication of this 
final rule. The guidance should provide more specific guidance for the 
ESRD community on how to comply with the requirements in this final 
rule.
    After consideration of the comments we received on these 
provisions, and the general comments we received on the proposed rule, 
as discussed earlier and in the hospital section (section II.C. of this 
final rule), we are finalizing the proposed emergency preparedness 
requirements for ESRD facilities with the following modifications:

[[Page 63929]]

     Revising the introductory text of Sec.  494.62 by adding 
the term ``local'' to clarify that dialysis facilities must also comply 
with local emergency preparedness requirements.
     Revising Sec.  494.62(a)(4) by deleting the term 
``ensuring'' and replacing the term ``ensure'' with ``maintain.''
     Revising Sec.  494.62(b)(1) by clarifying that tracking 
during and after the emergency applies to on-duty staff and sheltered 
patients. We have also revised paragraph (b)(1) to provide that if on-
duty staff and sheltered patients are relocated during the emergency, 
the dialysis facility must document the specific name and location of 
the receiving facility or other location.
     Revising Sec.  494.62(b)(4) to change the phrase ``ensures 
records are secure and readily available'' to ``secures and maintains 
availability of records.''
     Revising Sec.  494.62(b)(6) to replace the term ``ensure'' 
with ``maintain.''
     Revising Sec.  494.62(b)(8) to delete the phrase ``a 
process to ensure that'' and replacing the term with ``How.''
     Revising Sec.  494.62(b)(9) to delete the phrase 
``ensuring that'' and replacing it with the term ``by which the staff 
can confirm.''
     Revising Sec.  494.62(c), by adding the term ``local'' to 
clarify that the dialysis facility must develop and maintain an 
emergency preparedness communication plan that also complies with local 
laws.
     Revising Sec.  494.510(c)(5) to clarify that the dialysis 
facility must develop a means, in the event of an evacuation, to 
release patient information, as permitted under 45 CFR 
164.510(b)(1)(ii).
     Revising Sec.  494.62(d) by adding that each dialysis 
facility's training and testing program must be based on the dialysis 
facility's emergency plan, risk assessment using an all hazards 
approach, policies and procedures, and communication plan.
     Revising Sec.  494.62(d)(1)(iii) to replace the phrase 
``ensure that staff can demonstrate knowledge'' to ``demonstrate staff 
knowledge.''
     Revising Sec.  494.62(d)(2)(i) by replacing the term 
``community mock disaster drill'' with ``full-scale exercise.''
     Revising Sec.  494.62(d)(2)(ii) to allow a dialysis 
facility to choose the type of exercise it will conduct to meet the 
second annual testing requirement.
     Adding Sec.  494.62(e) to allow a separately certified 
dialysis facilities within a healthcare system to elect to be a part of 
the healthcare system's emergency preparedness program.

III. Provisions of the Final Regulations

A. Changes Included in the Final Rule

    In this final rule, we are adopting the provisions of the December 
27, 2013 proposed rule (78 FR 79082) with the following revisions:
     For all provider and supplier types, we are making a 
technical revision to clarify that facilities must also coordinate with 
local emergency preparedness systems.
     For RNHCIs, inpatient hospices, CAHs, ASCs, and hospitals, 
we are removing the requirement for facilities to track all staff and 
patients after an emergency and clarifying that in the event on-duty 
staff and sheltered patients are relocated during an emergency, the 
provider/supplier must document the specific name and location of the 
receiving facility or other location for staff and patients who leave 
the facility during the emergency.
     For home based hospices and HHAs, we are removing the 
tracking requirement and requiring that in the event there is an 
interruption in services during or due to an emergency, the provider 
must have policies in place for following up with on-duty staff and 
patients to determine services that are still needed. In addition, they 
must inform state and local officials of any on-duty staff or patients 
that they are unable to contact.
     For ESRD facilities, CMHCs, LTC facilities, ICF/IIDs, PACE 
organizations, PRTFs, and OPOs we are clarifying that tracking during 
and after the emergency applies to on-duty staff and sheltered 
patients. We have also revised the regulations to provide that if on-
duty staff and sheltered patients are relocated during the emergency, 
the facility must document the specific name and location of the 
receiving facility or other location.
     We did not propose a tracking requirement for CORFs, RHCs, 
FQHCs, transplant centers, and Organizations and have not made any 
revisions regarding tracking for these facilities in this final rule.
     For ASCs and HHAs, we are removing the requirement that 
ASCs and HHAs develop arrangements with other ASCs/HHAs and other 
providers to receive patients in the event of limitations or cessation 
of operations to ensure the continuity of services to patients.
     For ASCs and HHAs, we are removing the requirement that 
the communication plan include the names and contact information for 
other ASCs/HHAs.
     For all provider and supplier types, we are making a 
technical revision to clarify that facilities must develop and maintain 
an emergency preparedness communication plan that also complies with 
local law.
     For RNHCIs, ASCs, hospices, PRTFs, PACE organizations, 
hospitals, LTC facilities, ICF/IIDs, CAHs, CMHCs, and dialysis 
facilities, we are clarifying that these provider and supplier types 
must have a means, in the event of an evacuation, to release patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
     For all provider and supplier types with the exception of 
RNHCIs, OPOs, and transplant centers, we are revising testing 
requirements by replacing the term ``community mock disaster drill'' 
with ``full-scale exercise.''
     For ASCs only, we are removing the requirement for 
participation in a community-based testing exercise and revising the 
requirement to only require ASCs to conduct an individual, facility-
based full scale testing exercise.
     For all provider and supplier types with the exception of 
RNHCIs, OPOs, and transplant centers, we are revising testing 
requirements to allow each facility to choose the type of exercise they 
must conduct to meet the second annual testing requirement.
     For hospitals, CAHs, and LTC facilities, we are revising 
emergency and standby power system requirements by removing the 
requirement for an additional 4 hours of generator testing and 
clarifying that a facility must meet the requirements of NFPA[supreg] 
99 2012 edition and NFPA[supreg] 110, 2010 edition.
     For hospitals, CAHs, and LTC facilities, we are revising 
emergency and standby power system requirements by removing the 
requirement that a facility must maintain fuel onsite and clarifying 
that facilities must have a plan to maintain operations unless the 
facility evacuates.
     For all provider and supplier types, we are adding a 
separate standard to the regulations text that will allow a separately 
certified healthcare facility within a healthcare system to elect to be 
a part of the healthcare systems unified emergency preparedness 
program.

B. Incorporation by Reference

    In this final rule, we are incorporating by reference the NFPA 
101[supreg] 2012 edition of the LSC, issued August 11, 2011, and all 
Tentative Interim Amendments issued prior to April 16, 2014; the NFPA 
99[supreg] 2012 edition of the Health Care Facilities Code, issued 
August 11, 2011, and all Tentative Interim Amendments issued prior to 
April 16, 2014; and the NFPA 110 [supreg] 2010 edition of the Standard 
for Emergency and Standby Power

[[Page 63930]]

Systems(including Tentative Interim Amendments to chapter 7), issued 
August 6, 2009.
     NFPA[supreg] 99, Health Care Facilities Code, 2012 
edition, issued August 11, 2011.
    ++ TIA 12-2 to NFPA[supreg] 99, issued August 11, 2011.
    ++ TIA 12-3 to NFPA[supreg] 99, issued August 9, 2012.
    ++ TIA 12-4 to NFPA[supreg] 99, issued March 7, 2013.
    ++ TIA 12-5 to NFPA[supreg] 99, issued August 1, 2013.
    ++ TIA 12-6 to NFPA[supreg] 99, issued March 3, 2014.
     NFPA[supreg] 101, Life Safety Code, 2012 edition, issued 
August 11, 2011;
    ++ TIA 12-1 to NFPA[supreg] 101, issued August 11, 2011.
    ++ TIA 12-2 to NFPA[supreg] 101, issued October 30, 2012.
    ++ TIA 12-3 to NFPA[supreg] 101, issued October 22, 2013.
    ++ TIA 12-4 to NFPA[supreg] 101, issued October 22, 2013.
     NFPA[supreg] 110, Standard for Emergency and Standby Power 
Systems, 2010 edition, including TIAs to chapter 7, issued August 6, 
2009.
    The materials that are incorporated by reference are reasonably 
available to interested parties and can be inspected at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD. 
Copies may be obtained from the National Fire Protection Association, 1 
Batterymarch Park, Quincy, MA 02169, www.nfpa.org, 1.617.770.3000. If 
any changes in this edition of the Code are incorporated by reference, 
CMS will publish a document in the Federal Register to announce the 
changes.
    The NFPA 101[supreg] 2012 edition of the LSC (including the TIAs) 
provides minimum requirements, with due regard to function, for the 
design, operation and maintenance of buildings and structures for 
safety to life from fire. Its provisions also aid life safety in 
similar emergencies.
    The NFPA 99[supreg] 2012 edition of the Health Care Facilities Code 
(including the TIAs) provides minimum requirements for health care 
facilities for the installation, inspection, testing, maintenance, 
performance, and safe practices for facilities, material, equipment, 
and appliances, including other hazards associated with the primary 
hazards.
    The NFPA 110[supreg] 2010 edition of the Standard for Emergency and 
Standby Power Systems (including the TIAs) provides minimum 
requirements for the installation, maintenance, operation, and testing 
requirements as they pertain to the performance of the emergency power 
supply system (EPSS).

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-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 final rule, a hospital's ICRs will 
differ from the ICRs of other Medicare or Medicaid provider and 
supplier types. We have calculated the ICR for each provider and 
supplier separately and have included a chart summarizing the burden at 
the end of each section. A significant factor in the burden for each 
provider or supplier type will be whether the type of facility provides 
inpatient services, outpatient services, or both. Moreover, even where 
the regulatory requirements are the same, certain factors will greatly 
affect the burden for different providers and suppliers, such as the 
size and location of the provider or supplier, whether or not they 
participate in any type of network, and whether they already have a 
substantial emergency preparedness program.
    We have determined that the development of an emergency plan is 
more labor intensive than conducting the risk assessment for a few 
reasons. In general, the risk assessment process requires following a 
checklist and/or filling out a table (see: https://asprtracie.hhs.gov/documents/tracie-evaluation-of-HVA-tools.pdf for a set of examples), 
whereas planning is a more comprehensive process that requires 
individual expertise, identifying mitigation options to problems, and 
documenting policies and procedures to mitigation potential challenges 
that may arise depending on the identified in their risk assessment. We 
also reference numerous resources in the preamble that are available 
for use by providers and suppliers to help develop their risk 
assessments. Also, in the final rule, we allow providers and suppliers 
who are part of integrated health systems to develop one risk 
assessment and we encourage them to work with their community health 
coalitions in doing so. As a result, we expect that it will take more 
time to complete the emergency plan in comparison to the amount of time 
it will take to conduct a risk assessment as the emergency plan must be 
unique to the specific facility to which it applies.
    In each section, where possible, we provide information regarding 
the characteristics which drive burden for each provider and supplier 
type. Current Medicare or Medicaid regulations for some providers and 
suppliers include requirements similar to those in this 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).
    We have determined that the time required to conduct an annual 
review and update of the emergency preparedness plan is dependent upon 
whether there are existing emergency preparedness requirements for the 
providers and suppliers. We believe that the providers and suppliers 
with existing emergency preparedness requirements have some sort of an 
emergency preparedness plan that is updated at least annually based on 
current standards of practice. For these providers and suppliers, no 
additional burden has been assigned for the annual review and update of 
the emergency preparedness plan. The following providers and suppliers 
currently have emergency preparedness requirements: RNCHIs, ASCs, PACE 
organizations, Hospitals, ICF/IIDs, HHAs, CORFs, CAHs, Organizations, 
RHCs, FQHCs, inpatient hospice, and ESRD facilities. For those 
providers and suppliers who do not have existing emergency preparedness 
requirements, we believe that it is less likely that there is an 
emergency preparedness plan that is reviewed and updated annually. For 
these providers and suppliers, we estimate that the time it takes to 
review and update the plan annually is equal to one-third of the amount 
of time it takes to develop their emergency preparedness plan. The 
following

[[Page 63931]]

providers and suppliers currently do not have emergency preparedness 
requirements: CMHCs, OPOs, PRTFs and outpatient hospices.
    Furthermore, some accrediting organizations (AOs) that have CMS-
approved accreditation programs for Medicare providers and suppliers 
have emergency preparedness standards. Those organizations are: The 
Joint Commission (TJC), the American Osteopathic Association/Healthcare 
Facilities Accreditation Program (AOA/HFAP), the Accreditation 
Association for Ambulatory Health Care, Inc. (AAAHC), the American 
Association for Accreditation for Ambulatory Surgery Facilities, Inc. 
(AAAASF), and Det Norske Veritas (DNV) GL--Healthcare (DNV GL). 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 will have a 
smaller burden associated with this final 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 and 
Shimizu I. ``Hospital preparedness for emergency response: United 
States, 2008.'' National Health Statistics Reports. (2011): 1-14).
    Hospitals, as well as other healthcare 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 will continue in a 
predictable manner. We also do not know how the hospitals spent this 
funding. Therefore, in determining the burden for this final rule, we 
did not take into account any funding a hospital or other healthcare 
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 
June 2016, unless indicated otherwise. We have not included data for 
healthcare 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 2014 National Occupational Employment and Wage Estimates, 
United States by the Bureau of Labor Statistics at http://www.bls.gov/oes/current/oes_nat.htm. In the proposed rule we added a 30 percent 
increase for overhead and benefits. For the final rule, we have 
calculated the estimated hourly rates in this final rule based upon the 
national mean salary for that particular position to include a 100 
percent increase for overhead and 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.
    Salary may 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. Many healthcare providers and suppliers 
could reduce their burden by partnering or collaborating with other 
facilities to develop their emergency management plans or programs. Due 
to a lack of data, we did not consider this in our burden estimates. In 
estimating the burden associated with this final rule, we took into 
consideration the many free or low cost emergency management resources 
healthcare facilities have available to them and assume that many 
providers will use only these resources in order to meet the 
requirements of this rule. If we feel an organization may hire a 
consultant or contractor, we have indicated such. Following is a list 
of some of the available resources:
    Department of Health and Human Services (HHS), Office of the 
Assistant Secretary for Preparedness and Response (ASPR).
     http://asprtracie.hhs.gov/ Technical Resources, Assistance 
Center, and Information Exchange (TRACIE).
     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.gv/training-technical-assistance.
    Comment: Multiple commenters believe that we underestimated the 
amount of time and work it will take for many providers and suppliers 
to come into compliance with our proposed requirements. Specifically, 
some commenters expressed that we did not truly capture what updating 
policies and procedures will entail. The commenters explained that 
updating policies and procedure will go beyond having meetings, 
drafting revisions, and obtaining approvals. They expressed that 
updating policies and procedures would also involve researching 
alternatives, assessing costs that may be involved, reviewing potential 
changes with affected employees, implementing the changes, and training 
staff and testing outcomes.
    Response: We appreciate the commenter's feedback and understand

[[Page 63932]]

their concerns. As discussed earlier in the preamble, we recognize the 
level of work it will take for facilities to come into compliance with 
these requirements. While we understand that updating policies and 
procedures can involve many tasks and that for some facilities 
emergency preparedness requirements may be new. We believe that 
periodically reviewing and updating policies and procedures is a 
standard business practice for healthcare facilities since they must 
comply with applicable federal, state, and local laws, regulations, and 
ordinances that periodically change. Adding disaster related policies 
may be a new task for some, but the process of updating policies and 
procedures will not be a brand new burden. As part of an annual review 
and update, staff are required to be trained and be familiar with many 
policies and procedures in the operation of their facility and are held 
responsible for knowing these requirements. Annual reviews help to 
refresh these policies and procedures which would include any revisions 
to them based on the facility experiencing an emergency or as a result 
of a community or natural disaster. Basic contact information and 
procedures could be updated during an annual review. We would not 
expect that an annual review would be an extensive overhaul of their EP 
plan. Healthcare facilities routinely revise and update policies and 
operational procedures to ensure that they are operating based on best 
practices.
    Therefore, we accounted for the staff time that will be involved to 
review and update current policies and procedures for alignment with 
these emergency preparedness requirements.
    Comment: Some commenters believe that we incorrectly estimated the 
salaries of the staff involved in meeting the requirements. A commenter 
questioned whether CMS could use average wages by region for 
determining the salaries, rather than national average wages. The 
commenter believes that the wages used in the proposed rule were low 
for their area, therefore underestimating the estimates for conducting 
the risk assessment and developing the emergency plan.
    Response: As indicated in the proposed rule, we obtained all salary 
information for the different positions identified in the following 
assessments from the National Occupational Employment and Wage 
Estimates, United States by the Bureau of Labor Statistics (BLS). We 
calculated the estimated hourly rates based upon the national mean 
salary for that particular position, including a 30 percent increase 
for overhead and benefits. In this final rule, we have updated the 
salary data as indicated by the BLS data. The final rule salaries 
include a 100 percent increase for overhead and 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.
    Comment: A commenter believes that we miscalculated the time and 
expense required in planning and carrying out a community-based drill. 
The commenter believes that while most unaccredited providers and 
suppliers probably would not be starting from scratch with regard to 
drills and exercises, our description of the tasks and burdens 
associated with organizing a drill is still insufficient. The commenter 
believes that we did not provide a thorough explanation of what the 
emergency drill process would actually entail. The commenter points out 
that planning would include tasks such as contacting other providers 
and community emergency response agencies, convening with this group on 
a regular basis, and writing the hospital's part of the exercise. They 
also suggest that participating in the drill would include recruiting 
volunteers, informing patients about the drill, and obtaining financial 
approval to conduct the drills. The commenter believes that given all 
of this, it could more realistically take six months to a year to plan 
and carry out a comprehensive emergency drill and urges CMS to revise 
our estimates to more accurately reflect the time and resources 
involved.
    Response: The regulation would require some providers to 
participate in a community-based training exercise where available. We 
are not requiring facilities to plan and execute a community-wide 
exercise, only participate to the extent their facility would 
contribute in an emergency situation if the whole community/town is 
impacted. When a community-based exercise is not accessible, facilities 
would conduct a facility-based training. As the commenter pointed out, 
we did not provide prescriptive emergency exercises and drills. 
Instead, we provided resources that facilities can utilize in 
developing their drills and exercises. The time estimates we used to 
calculate the burden associated with conducting a drill for each 
provider and supplier were our best estimates for the activity. Our 
estimates serve as a baseline for the time it will take to implement 
the task, understanding that the actual time and task involved will 
vary for each individual facility based on the unique circumstances of 
each facility. We provided a time estimate for the activities that, at 
a minimum, each facility will have to take into consideration when 
conducting a community drill.
    Comment: We received conflicting comments regarding the staff 
positions that will be involved in the activities of developing the 
emergency preparedness programs. For example, one commenter indicated 
that in addition to an administrator and director of nursing, a plant 
manager and food service manager will also need to be included in the 
process of developing the plan and conducting the risk assessment. 
Other commenters indicated that the majority of the burden associated 
with developing plans, updating policies and procedures, and 
facilitating/planning trainings and testing will fall on the 
administrator.
    Response: Based upon our experience with the various providers and 
suppliers, we determined the staff positions that would likely be 
involved in complying with the varying requirements for the different 
providers and suppliers. The actual individuals who are involved in the 
activities needed to comply with the requirements in this final rule 
will vary based on the unique circumstances of each individual 
healthcare facility. Our estimates provide an overall idea of the 
necessary staff positions involved, but we note that ultimately the 
actual individuals involved will be determined by the individual 
facility. We have listed personnel that would address various 
components of the EP requirements in both the ICR and RIA sections of 
the rule.

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

    Section 403.748(a) will require RNHCIs to develop and maintain an 
emergency preparedness plan that must be reviewed and updated at least 
annually. We proposed 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

[[Page 63933]]

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 will 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 will 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 will require the involvement of an administrator, the 
director of nursing, and the head of maintenance. It is important to 
note that RNHCIs do not provide medical care to their patients. 
Depending upon the state in which they are located, RNHCIs may not be 
licensed and may not have licensed or certified staff. RNHCIs do not 
compensate their staff at the same level we have used to determine the 
burden for other healthcare 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 (2 hours), the director of nursing (5 hours), and the 
head of maintenance (2 hours) will 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 will 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 will require 9 burden hours for each RNHCI to 
complete the risk assessment at a cost of $366. There are 18 RNHCIs. 
Therefore, it will require an estimated 162 annual burden hours (9 
burden hours for each RNHCI x 18 RNHCIs) for all 18 RNHCIs to comply 
with this requirement at a cost of $6,588 ($366 estimated cost for each 
RNHCI x 18 RNHCIs).

                      Table 1--Total Cost Estimate for a RNHCI To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $72               2            $144
Director of Nursing.............................................              34               5             170
Head of Maintenance.............................................              26               2              52
                                                                 -----------------------------------------------
    Total.......................................................  ..............               9             366
----------------------------------------------------------------------------------------------------------------

    After conducting a risk assessment, RNHCIs will 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 (Sec.  403.742(a)(4)). However, based on our 
experience with RNHCIs, their plans likely will address only evacuation 
from their facilities. We expect that all RNHCIs will 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 will be involved in developing the emergency 
preparedness plan. However, we expect that it will require 
substantially more time to complete the plan than to complete the risk 
assessment. We estimate that complying with this requirement will 
require 12 burden hours for each RNHCI at a cost of $498. Therefore, 
for all 18 RNHCIs to comply with these requirements will require an 
estimated 216 burden hours (12 burden hours for each RNHCI x 18 RNHCIs) 
at a cost of $8,964 ($498 estimated cost for each RNHCI x 18 RNHCIs).

               Table 2--Total Cost Estimate for a RNHCI To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $72               3            $216
Director of Nursing.............................................              34               6             204
Head of Maintenance.............................................              26               3              78
                                                                 -----------------------------------------------
    Totals......................................................  ..............              12             498
----------------------------------------------------------------------------------------------------------------

    Under this final rule, RNHCIs will 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 will 
expect that RNHCIs already review their plans annually. Based on our 
experience with Medicare providers and suppliers, healthcare facilities 
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 will constitute a usual and customary business practice as defined 
in the implementing regulation of the PRA at 5 CFR 1320.3(b)(2). 
Therefore, we have not assigned a burden.
    Section 403.748(b) will 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), 
the risk assessment at paragraph (a)(1), and the communication plan at 
paragraph (c). These policies and procedures will have to be reviewed 
and updated at least annually. At a minimum, we proposed that the 
policies and procedures be required to address the requirements 
specified in Sec.  403.748(b)(1) through (8). The RNHCIs will need to 
review their

[[Page 63934]]

policies and procedures and compare them to their emergency plan, risk 
assessment, and communication plan. Most RNHCIs will 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 (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 will involve the administrator, the 
director of nursing, and the head of maintenance. All three will need 
to review and comment on the RNHCI's current policies and procedures. 
The director of nursing will 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 will 
require 6 burden hours for each RNHCI to comply with this requirement 
at a cost of $234. Thus, it will require 108 burden hours (6 burden 
hours for each RNHCI x 18 RNHCIs) for all 18 RNHCIs to comply with the 
requirements in Sec.  403.748(b)(1) through (8) at a cost of $4,212 
($234 estimated cost for each RNHCI x 18 RNHCIs).

                 Table 3--Total Cost Estimate for a RNHCI To Develop New Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $72               1             $72
Director of Nursing.............................................              34               4             136
Head of Maintenance.............................................              26               1              26
                                                                 -----------------------------------------------
    Totals......................................................  ..............               6             234
----------------------------------------------------------------------------------------------------------------

    Section 403.748(c) will 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 proposed that the communication plan include the 
information specified at Sec.  403.748(c)(1) through (7). The burden 
associated with complying with this requirement will 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 will require the involvement of the 
RNHCI's administrator, the director of nursing, and the head of 
maintenance. We estimate that complying with this requirement will 
require 4 burden hours for each RNHCI at a cost of $166. Thus, it will 
require an estimated 72 burden hours (4 burden hours for each RNHCI x 
18 RNHCIs) at a cost of $2,988 ($166 estimated cost for each RNHCI x 18 
RNHCIs).

                    Table 4--Total Cost Estimate for a RNHCI To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $72               1             $72
Director of Nursing.............................................              34               2              68
Head of Maintenance.............................................              26               1              26
                                                                 -----------------------------------------------
    Totals......................................................  ..............               4             166
----------------------------------------------------------------------------------------------------------------

    We proposed that RNHCIs will 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 will 
constitute a usual and customary business practice and will not be 
subject to the PRA in accordance with the implementing regulation of 
the PRA at 5 CFR 1320.3(b)(2). Therefore, we have not assigned a 
burden.
    Section 403.748(d) will 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) will require RNHCIs to provide initial training in 
emergency preparedness policies and procedures to all new and existing 
staff, individuals providing services under arrangement, and 
volunteers, consistent with their expected roles, and maintain 
documentation of the training. Thereafter, the RNHCI will have to 
provide training at least annually. Based on our experience, all RNHCIs 
have some type of emergency preparedness training program. However, all 
RNHCIs will 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 will require the 
involvement of the RNHCI administrator and the director of nursing. We 
estimate that it will require 7 burden hours for each RNHCI to develop 
an emergency training program at a cost of $314. Thus, it will require 
an estimated 126 burden hours (7 burden hours for each RNHCI x 18 
RNHCIs) at a cost of $5,652 ($1855 estimated cost for each RNHCI x 18 
RNHCI).

                     Table 5--Total Cost Estimate for a RNHCI To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $72               2            $144

[[Page 63935]]

 
Director of Nursing.............................................              34               5             170
                                                                 -----------------------------------------------
    Totals......................................................  ..............               7             314
----------------------------------------------------------------------------------------------------------------

    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, healthcare 
facilities 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 will constitute a usual and 
customary business practice as defined in the implementing regulation 
of the PRA at 5 CFR 1320.3(b)(2). Therefore, we have not calculated an 
estimate of the burden.
    Section 403.748(d)(2) will 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 will be 
the resources RNHCIs will 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 
will not be fully compliant with our requirements. We expect that the 
director of nursing will develop the scenarios and required 
documentation. We estimate that these tasks will require 3 burden hours 
at a cost of $102 for each RNCHI. Based on this estimate, for all 18 
RNHCIs to comply with these requirements will require 54 burden hours 
(3 burden hours for each RNHCI x 18 RNHCIs) at a cost of $1,836 ($102 
estimated cost for each RNHCI x 18 RNHCI).

                     Table 6--Total Cost Estimate for a RNHCI To Conduct Training Exercises
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Director of Nursing.............................................             $34               3            $102
                                                                 -----------------------------------------------
    Totals......................................................  ..............               3             102
----------------------------------------------------------------------------------------------------------------


    Table 7--Burden Hours and Cost Estimates for All 18 RNHCIs To Comply With the ICRs Contained In Sec.   403.748 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                               Number of    Number of    Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)             OMB Control No.      respondents   responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   403.748(a)(1)...............  0938-New..............            18           18            9          162           **         6,588        6,588
Sec.   403.748(a)(1)-(4)...........  0938-New..............            18           18           12          216           **         8,964        8,964
Sec.   403.748(b)..................  0938-New..............            18           18            6          108           **         4,212        4,212
Sec.   403.748(c)..................  0938-New..............            18           18            4           72           **         2,988        2,988
Sec.   403.748(d)(1)...............  0938-New..............            18           18            7          126           **         5,652        5,652
Sec.   403.748(d)(2)...............  0938-New..............            18           18            3           54           **         1,836        1,836
                                                            --------------------------------------------------------------------------------------------
    Totals.........................  ......................            18          108  ...........          738  ............  ...........       30,240
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 7.

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

    Section 416.54(a) will require ASCs to develop and maintain an 
emergency preparedness plan and review and update that plan at least 
annually. We proposed 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 in 
this final rule beginning with the risk assessment requirement in Sec.  
416.54(a)(1). We expect that each ASC will conduct a thorough risk 
assessment. This will require the ASC to develop a documented, 
facility-based and community-based risk assessment utilizing an all-
hazards approach. We expect that an ASC will consider its location and 
geographical area; patient population, including those with 
disabilities and other access and functional needs; and the type of 
services the ASC has the ability to provide in an emergency. The ASC 
also will 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 will be the time and 
effort necessary to perform a thorough risk assessment. As of June 
2016, there are 5,485 ASCs. The current regulations covering ASCs 
include emergency preparedness requirements.
    A significant factor in determining the burden is the accreditation 
status of an ASC. Of the 5,485 ASCs, 4,071 are non-accredited and 1,414 
are accredited. Of the 1,414 accredited ASCs, we estimate that 491 are 
accredited by The Joint Commission (TJC), 731 by the AAAHC, and 
additional facilities are accredited by the AOA/HFAP or the AAAASF. The 
accreditation standards for these organizations vary in their 
requirements

[[Page 63936]]

related to emergency preparedness. The AOA/HFAP'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/HFAP and AAAASF will not 
significantly satisfy the ICRs contained in this final rule. Therefore, 
for the purpose of determining the burden imposed on ASCs by this final 
rule, we will include the ASCs that are accredited by both the AOA/HFAP 
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/HFAP or AAAASF. For example, TJC standards contain 
requirements for risk assessments and an emergency management plan. 
AAAHC's standards include requirements for both internal and external 
emergencies and drills for the facility's internal emergency plan. 
Therefore, in discussing the individual burden requirements in this 
final rule, we will discuss the burden for the estimated 1,222 
accredited ASCs by either the AAAHC or TJC (731 AAAHC-accredited ASCs + 
491 TJC-accredited ASCs) separately from the remaining 4,263 (ASCs that 
are not accredited by an accrediting organization or accredited by the 
AOA/HFAP and AAAASF). For some requirements, only the TJC accreditation 
standards are significantly like those in the final rule. For those 
requirements, we will analyze the 491 TJC-accredited ASCs separately 
from the 4,994 non TJC-accredited ASCs (5,485 ASCs-491 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 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 requirement will be negligible. For the 491 TJC-accredited ASCs, 
the risk assessment requirement will constitute a usual and customary 
business practice. While this requirement is subject to the PRA, we 
expect that complying with this requirement will constitute a usual and 
customary business practice as defined in the implementing regulations 
of the PRA at 5 CFR 1320.3(b)(2). Therefore, we have not estimated the 
amount of regulatory burden For ASCs with accreditation from TJC.
    For the purpose of determining the burden for the 731 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 731 AAAHC-accredited ASCs have performed some type of risk 
assessment. However, we do not expect that this will satisfy the 
requirement for a facility-based and community-based risk assessment 
that addresses the elements include in the AAAHC-accreditation for 
ASCs. Therefore, the 731 AAAHC-accredited ASCs will be included in the 
burden analysis with the ASCs that are non-accredited or are accredited 
by AOA/HFAP and AAAASF for the risk assessment requirement for 4,994 
non TJC-accredited ASCs (5,485 total ASCs-491 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 will 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 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 healthcare providers and suppliers, need maximum 
flexibility in determining the best way for their facilities to 
accomplish this task. However, we expect healthcare 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 will 
require the involvement of an administrator and a registered nurse. We 
expect that to comply with the requirements of this section, both of 
these individuals will 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 will 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 will require 8 burden hours for 
each ASC at a cost of $763. Based on that estimate, it will require 
39,952 burden hours (8 burden hours for each ASC x 4,994 non TJC-
accredited ASCs) for all non TJC-accredited ASCs to comply with this 
risk assessment requirement at a cost of $3,810,422 ($763 estimated 
cost for each ASC x 4,994 ASCs).

             Table 8--Total Cost Estimate for a Non-TJC Accredited ASC To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $110               5            $550
Registered Nurse--Quality Improvement...........................              71               3             213
                                                                 -----------------------------------------------

[[Page 63937]]

 
    Total.......................................................  ..............               8             763
----------------------------------------------------------------------------------------------------------------

    After conducting the risk assessment, ASCs will 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 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 will be negligible. Thus, for 491 TJC-accredited ASCs, 
this requirement will constitute a usual and customary business 
practice for these ASCs in accordance with the implementing regulations 
of the PRA at 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 731 AAAHC-
accredited ASCs in the burden analysis for this requirement.
    We expect that the 4,994 non TJC-accredited ASCs have developed 
some type of emergency preparedness plan. However, under this final 
rule, all of these ASCs will have to review their current plans and 
compare them to the risk assessments they performed in accordance with 
Sec.  416.54(a)(1). The ASCs will 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 requirements. The ASC 
will also need to review, revise, and, in some cases, develop the 
delegations of authority and succession plans that ASCs determine are 
necessary for the appropriate initiation and management of their 
emergency preparedness plans.
    The burden associated with this requirement will be the time and 
effort necessary to develop an emergency preparedness plan that 
complies with all of the requirements in Sec.  416.54(a)(1) through 
(4). Based upon our experience with ASCs, we expect that the 
administrator and the quality improvement nurse who will be involved in 
the risk assessment will also be involved in developing the emergency 
preparedness plan. We estimate that complying with this requirement 
will require 11 burden hours for each ASC at a cost of $937. Therefore, 
based on that estimate, for the 4,994 non TJC-accredited ASCs to comply 
with the requirements in this section will require 54,934 burden hours 
(11 burden hours for each non TJC-accredited ASC x 4,994 non TJC-
accredited ASCs) at a cost of $4,679,378 ($937 estimated cost for each 
non TJC-accredited ASC x 4,994 non TJC-accredited ASCs).

       Table 9--Total Cost Estimate for a Non-TJC Accredited ASC To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $110               4            $440
Registered Nurse-Quality Improvement............................              71               7             497
                                                                 -----------------------------------------------
    Total.......................................................  ..............              11             937
----------------------------------------------------------------------------------------------------------------

    All of the ASCs will 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 will expect that ASCs 
will review their plans annually. All ASCs have a professional staff 
person, 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 will be primarily responsible for 
the annual review of the ASC's emergency preparedness plan. We expect 
that complying with this requirement will constitute a usual and 
customary business practice for ASCs in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Therefore, 
we will not include this activity in the burden analysis.
    Section 416.54(b) proposed that each ASC be required to develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a), the risk assessment at 
paragraph (a)(1), and the communication plan set forth in paragraph 
(c). We will require ASCs to review and update these policies and 
procedures at least annually. These policies and procedures will be 
required to include, at a minimum, the requirements listed at Sec.  
416.54(b)(1) through (7). We expect that ASCs will develop emergency 
preparedness policies and procedures based upon their risk assessments, 
emergency preparedness plans, and communication plans. Therefore, ASCs 
will need to thoroughly review their emergency preparedness policies 
and procedures and compare them to all of the information previously 
noted. The ASCs will then need to revise, or in some cases, develop new 
policies and procedures that will ensure that the ASCs' emergency 
preparedness plans address the specific elements.
    TJC accreditation standards already require many of the specific 
elements that are required in this section. 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

[[Page 63938]]

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 will 
constitute only a negligible burden. For the 491 TJC-accredited ASCs, 
the requirement for emergency preparedness policies and procedures will 
constitute a usual and customary business practice in accordance with 
the implementing regulations of the PRA 5 CFR 1320.3(b)(2). Therefore, 
we will not include this activity in the burden analysis for these 491 
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 Sec.  
416.54(b).
    We expect that all of the 4,994 non TJC-accredited ASCs have some 
emergency preparedness policies and procedures. However, we expect that 
all of these ASCs will need to review their policies and procedures and 
revise their policies and procedures to ensure that they address all of 
the requirements. We expect that the quality improvement nurse will 
initially review the ASC's emergency preparedness policies and 
procedures. The quality improvement nurse will send any recommendations 
for changes or additional policies or procedures to the ASC's 
administrator. The administrator and quality improvement nurse will 
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 requirement will require 9 burden hours at a cost of 
$717. For the 4,994 ASCs to comply with this requirement, it will 
require an estimated 44,946 burden hours (9 burden hours for each non 
TJC-accredited ASC x 4,994 non TJC-accredited ASCs) at a cost of 
$3,580,698. ($717 estimated cost for each non TJC-accredited ASC x 
4,994 ASCs).

        Table 10--Total Cost Estimate for a Non-TJC Accredited ASC To Develop New Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $110               2            $220
Registered Nurse-Quality Improvement............................              71               7             497
                                                                 -----------------------------------------------
    Total.......................................................  ..............               9             717
----------------------------------------------------------------------------------------------------------------

    Section 416.54(c) will require each ASC to develop and maintain an 
emergency preparedness communication plan that complies with both 
federal and state law. We also proposed that ASCs will have to review 
and update these plans at least annually. These communication plans 
will 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 will 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.
    TJC-accredited ASCs are required to have a plan that ``identifies 
backup internal and external communication systems in the event of 
failure during emergencies'' (CAMAC, Standard EC.4.10, EP 18, p. EC-
13). There are also requirements for identifying, notifying, and 
assigning staff, as well as notifying external authorities (CAMAC, 
Standard EC.4.10, EPs 7-9, p. EC-13). In addition, the facility's plan 
must provide for controlling information about patients (CAMAC, 
Standard EC.4.10, EP 10, p. EC-13). If any revisions or additions are 
necessary to satisfy the requirements, we expect the revisions or 
additions will be those incurred during the course of normal business 
and thereby impose no additional burden. Thus, for the TJC-accredited 
ASCs, the requirements for the emergency preparedness communication 
plan will constitute a usual and customary business practice for ASCs 
as stated in the implementing regulations of the PRA at 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 AAAHC does have a specific 
requirement for a communication plan, we will include the AAAHC-
accredited ASCs in with the non-accredited ASCs in determining the 
burden for these requirements for a total of 4,994 non TJC-accredited 
ASCs (5,485 total ASCs-491 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 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; and a method for sharing information and 
medical documentation with other healthcare providers to ensure 
continuity of care for their patients. We expect that all ASCs already 
satisfy the requirements in Sec.  416.54(c)(1) through (4). However, 
for the requirements in Sec.  416.54(c)(5) through (7), all ASCs will 
need to review, revise, and, if necessary, develop new sections for 
their plans to ensure that they include all of the requirements. We 
expect that this will require the involvement of the ASC's 
administrator and a registered nurse. We estimate that complying with 
this requirement will require 4 burden hours at a cost of $323. 
Therefore, for all non

[[Page 63939]]

TJC-accredited ASCs to comply with the requirements in this section 
will require an estimated 19,976 burden hours (4 hours for each non 
TJC-accredited ASC x 4,994 non TJC-accredited ASCs) at a cost of 
$1,613,062 ($323 estimated cost for each non TJC-accredited ASC x 4,994 
non TJC-accredited ASCs).

           Table 11--Total Cost Estimate for a Non-TJC Accredited ASC To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $110               1            $110
Registered Nurse-Quality Improvement............................              71               3             213
                                                                 -----------------------------------------------
    Total.......................................................  ..............               4             323
----------------------------------------------------------------------------------------------------------------

    We also proposed 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, we believe complying with this requirement 
will constitute a usual and customary business practice for ASCs as 
stated in the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    Section 416.54(d) will 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 Sec.  416.54(d)(1) and (2).
    The burden associated with complying with these requirements will 
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. Since ASCs are currently required to conduct drills, 
at least annually, to test their disaster plan's effectiveness, we 
expect that all ASCs already provide training on their emergency 
preparedness policies and procedures. However, all ASCs will 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.
    Section 416.54(d)(1) will 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 will have to ensure that 
their staff can demonstrate knowledge of emergency procedures. 
Thereafter, ASCs will 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 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 healthcare professionals. This AAAHC-accredited 
requirement does not ensure that these ASCs are already complying with 
the 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 5,485 ASCs 
have some type of emergency preparedness training program. We also 
expect that these ASCs will need to review their training programs and 
compare them to their risk assessments, emergency preparedness plans, 
policies and procedures, and communication plans. The ASCs will 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 will require the involvement of an administrator 
and a quality improvement nurse. We estimate that for each ASC to 
develop a comprehensive emergency training program will require 6 
burden hours at a cost of $465. Therefore, the estimated annual burden 
for all 5,485 ASCs to comply with these requirements is 32,910 burden 
hours (6 burden hours x 5,4855 ASCs) at an estimated cost of $2,550,525 
($465 estimated cost for each ASC x 5,485 ASCs).

                     Table 12--Total Cost Estimate for an ASC To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $110               1            $110
Registered Nurse-Quality Improvement............................              71               5             355
                                                                 -----------------------------------------------
    Total.......................................................  ..............               6             465
----------------------------------------------------------------------------------------------------------------

    We proposed that ASCs will 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 will expect 
that ASCs

[[Page 63940]]

will 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 a 
registered nurse will be primarily responsible for the annual review of 
the ASC's emergency preparedness training program. Thus, in accordance 
with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2), we 
believe complying with this requirement will constitute a usual and 
customary business practice for ASCs. Thus, we will not include this 
activity in this burden analysis.
    Section 416.54(d)(2) will require ASCs to participate in a full-
scale exercise at least annually. ASCs will also have to participate in 
one additional testing exercise of their choice at least annually. If 
the ASC experiences an actual natural or man-made emergency that 
requires activation of their emergency plan, the ASC will be exempt 
from the requirement for a full-scale exercise for 1 year following the 
onset of the actual event. ASCs will 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 will need to develop a 
scenario for each drill and exercise. ASCs will also need to develop 
the documentation necessary for recording what happened during the 
testing 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 testing 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 testing 
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 5,485 
ASCs will be required to develop scenarios for their testing exercises 
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 will 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 will require the involvement of an 
administrator and a registered nurse. We estimate that for each ASC to 
comply will require 5 burden hours at a cost of $394. Therefore, for 
all 5,485 ASCs to comply with this requirement will require an 
estimated 27,425 burden hours (5 burden hours for each ASC x 5,485 
ASCs) at a cost of $2,161,090 ($394 estimated cost for each ASC x 5,485 
ASCs).

                     Table 13--Total Cost Estimate for an ASC To Conduct Training Exercises
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $110               1            $110
Registered Nurse-Quality Improvement............................              71               4             284
                                                                 -----------------------------------------------
    Total.......................................................  ..............               5             394
----------------------------------------------------------------------------------------------------------------


    Table 14--Burden Hours and Cost Estimates for all 5,485 ASCs To Comply With the ICRs Contained in Sec.   416.54 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Total     Hourly labor  Total labor
                                                                                   Burden per     annual       cost of      cost of
      Regulation section(s)         OMB Control No.     Respondents   Responses     response      burden      reporting    reporting     Total cost ($)
                                                                                    (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   416.54(a)(1).............  0938-New...........         4,994        4,994            8       39,952           **     3,810,422          3,810,422
Sec.   416.54(a)(1)-(4).........  0938-New...........         4,994        4,994           11       54,934           **     4,679,378          4,679,378
Sec.   416.54(b)................  0938-New...........         4,994        4,994            9       44,946           **     3,580,698          3,580,698
Sec.   416.54(c)................  0938-New...........         4,994        4,994            4       19,976           **     1,613,062          1,613,062
Sec.   416.54(d)(1).............  0938-New...........         5,485        5,485            6       32,910           **     2,550,525          2,550,525
Sec.   416.54(d)(2).............  0938-New...........         5,485        5,485            5       27,425           **     2,161,090          2,161,090
                                                      --------------------------------------------------------------------------------------------------
    Totals......................  ...................        10,479       30,946  ...........      220,143  ............  ...........      18,395,175.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 14.


[[Page 63941]]

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

    Section 418.113(a) will require hospices to develop and maintain an 
emergency preparedness plan that must be reviewed and updated at least 
annually. We proposed that the plan meet the criteria listed in Sec.  
418.113(a)(1) through (4).
    Although 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.
    Section 418.113(a)(1) will 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 will need to consider its physical location, the 
geographic area in which it is located, and its patient population.
    The burden associated with this requirement will be the time and 
effort necessary to perform a thorough risk assessment. There are 4,401 
hospices. There are 3,989 hospices that provide care only to patients 
in their homes (home health based and freestanding hospices) and 412 
hospices that offer inpatient care directly (hospital, SNF, and NF 
based 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 (Sec.  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 will affect the hospice's ability 
to provide care,'' as stated in Sec.  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 Sec.  418.113(a). Therefore, we 
believe that all inpatient hospices will 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, healthcare 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 will 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'' (Sec.  
418.56(a)(2)). Thus, we believe the IDG will be involved in performing 
the risk assessment.
    We expect that members of the IDG will 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 will 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 will spend more time reviewing and working on the risk 
assessment than the other individuals in the IDG. We estimate it will 
require 10 burden hours to review and update the risk assessment at a 
cost of $759. There are 412 inpatient hospices. Therefore, based on 
that estimates, it will require 4,120 burden hours (10 burden hours for 
each inpatient hospice x 412 inpatient hospices) for all inpatient 
hospices to comply with this requirement at a cost of $312,708 ($759 
estimated cost for each inpatient hospice x 412 inpatient hospices).

               Table 15--Total Cost Estimate for an Inpatient Hospice To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $80               4            $320
Physician.......................................................             180               1             180
Counselor.......................................................              34               1              34
Social Worker...................................................              45               1              45
Registered Nurse................................................              60               3             180
                                                                 -----------------------------------------------
    Totals......................................................  ..............              10             759
----------------------------------------------------------------------------------------------------------------

    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 healthcare 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 will 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 will require 12 burden hours to develop its 
risk assessment at a cost of $899. Therefore, based on that estimate, 
for all 3,989 hospices that provide care to patients in their homes, it 
will require 47,868 burden hours (12 burden hours for each hospice x 
3,989 hospices) to comply with this requirement at a cost of $3,586,111 
($899 estimated cost for each hospice x 3,989 hospices). Based on the 
previous calculations, we estimate that for all 4,401 hospices to 
develop a risk assessment will require 51,988 burden hours at a cost of 
$3,898,819.

[[Page 63942]]



              Table 16--Total Cost Estimate for an Outpatient Hospice To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $80               5            $400
Physician.......................................................             180               1             180
Counselor.......................................................              34               1              34
Social Worker...................................................              45               1              45
Registered Nurse................................................              60               4             240
                                                                 -----------------------------------------------
    Totals......................................................  ..............              12             899
----------------------------------------------------------------------------------------------------------------

    After conducting the risk assessments, hospices will have to 
develop and maintain emergency preparedness plans that they will 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 Sec.  418.113(a)(1). In 
addition, hospices will have to comply with the requirements in Sec.  
418.113(a)(1) through (4). They will 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 will affect the hospice's ability to provide care'' 
(Sec.  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. Furthermore, 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 will have to review its current plan and compare 
it to its risk assessment, as well as to the other requirements we 
proposed. We expect that most inpatient hospices will need to update 
and revise their existing emergency plans, and, in some cases, develop 
new sections to comply with our requirements.
    The burden associated with this requirement will 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 will 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 will 
require more time to complete than the risk assessment.
    We expect that these individuals will have to attend an initial 
meeting, review relevant sections of the facility's current emergency 
preparedness or disaster plan(s), develop comments and recommendations 
for changes to the facility's plan, attend a follow-up meeting, perform 
a final review, and approve the emergency plan. We expect that the 
administrator will 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 will probably spend 
more time reviewing and working on the emergency plan than the other 
individuals. We estimate that it will require 14 burden hours for each 
inpatient hospice to develop its emergency preparedness plan at a cost 
of $1,159. Based on this estimate, it will require 5,768 burden hours 
(14 burden hours for each inpatient hospice x 412 inpatient hospices) 
for all inpatient hospices to complete their plans at a cost of 
$477,508 ($1,159 estimated cost for each inpatient hospice x 412 
inpatient hospices).

        Table 17--Total Cost Estimate for an Inpatient Hospice To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $80               6            $480
Physician.......................................................             180               2             360
Counselor.......................................................              34               1              34
Social Worker...................................................              45               1              45
Registered Nurse................................................              60               4             240
                                                                 -----------------------------------------------
    Totals......................................................  ..............              14           1,159
----------------------------------------------------------------------------------------------------------------

    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 healthcare 
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 will need to review 
its emergency plan to ensure that it addressed the risks identified in 
its risk assessment and complied with the requirements. We expect that 
an administrator and the individuals from the hospice's IDG will 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 will 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 requirement will require 20 burden hours at an estimated cost 
of $1,599. Based on that estimate, for all 3,989 of these hospices to 
comply with this

[[Page 63943]]

requirement will require 79,780 burden hours (20 burden hours for each 
hospice x 3,989 hospices) at a cost of $6,378,411 ($1,599 estimated 
cost for each hospice x 3,989 hospices). We estimate that for all 4,401 
hospices to develop an emergency preparedness plan will require 
6,378,411 burden hours at a cost of $6,855,919.

        Table 18--Total Cost Estimate for an Outpatient Hospice To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $80              10            $800
Physician.......................................................             180               2             360
Counselor.......................................................              34               1              34
Social Worker...................................................              45               1              45
Registered Nurse................................................              60               6             360
                                                                 -----------------------------------------------
    Totals......................................................  ..............              20           1,599
----------------------------------------------------------------------------------------------------------------

    Hospices will 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 will 
expect that under this final rule, inpatient hospices will review their 
emergency plans prior to reviewing them with all of their employees and 
that this review will occur annually.
    Outpatient hospices, either home based or freestanding, on the 
other hand, currently do not have emergency preparedness requirements 
in the current hospice CoPs and as such, there is no requirement for an 
annual review of the plan. Therefore, we will analyze the burden from 
this requirement for outpatient hospices.
    Based on our experience with outpatient hospices, we expect that 
the same individuals who develop the emergency preparedness plan will 
annually review and update the plan. These staff would include the 
administrator, physician, counselor, social worker, and registered 
nurse. We estimate that for each hospice that provides care to patients 
in an outpatient setting to comply with this requirement will require 8 
burden hours at an estimated cost of $619. Based on that estimate, for 
all 3,989 of these hospices to comply with this requirement will 
require 31,912 burden hours (8 burden hours for each hospice x 3,989 
hospices) at a cost of $2,469,191 ($619 estimated cost for each hospice 
x 3,989 hospices).

   Table 19--Total Cost Estimate for an Outpatient Hospice To Review and Update an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $80               3            $240
Physician.......................................................             180               1             180
Counselor.......................................................              34               1              34
Social Worker...................................................              45               1              45
Registered Nurse................................................              60               2             120
                                                                 -----------------------------------------------
    Totals......................................................  ..............               8             619
----------------------------------------------------------------------------------------------------------------

    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 will 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 healthcare organizations to have a professional employee, an 
administrator, who periodically reviews their plans and procedures. We 
expect that complying with this requirement will constitute a usual and 
customary business practice and will not be subject to the PRA in 
accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2). Thus, we will not include this activity in the burden 
analysis.
    Section 418.113(b) will require each hospice to develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a), the risk assessment at 
paragraph (a)(1), and the communication plan at paragraph (c). It will 
also require hospices to review and update these policies and 
procedures at least annually. At a minimum, the hospice's policies and 
procedures will 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 will affect the hospice's ability 
to provide care'' (Sec.  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'' (Sec.  
418.56(a)(2)). However, we also expect that all inpatient hospices will 
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 will be the resources 
needed to ensure they comply with these requirements. Since at least 
one of a hospice's IDGs will be responsible for developing policies 
that govern the daily care and services for hospice

[[Page 63944]]

patients (42 CFR 418.56(a)(2)), we expect that an IDG will 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 
will require 8 burden hours at a cost of $619. Therefore, based on that 
estimate, all 412 inpatient hospices' compliance with this requirement 
will require 3,296 burden hours (8 burden hours for each inpatient 
hospice x 412 inpatient hospices) at a cost of $255,028 ($619 estimated 
cost for each inpatient hospice x 412 inpatient hospices).

          Table 20--Total Cost Estimate for an Inpatient Hospice To Develop New Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $80               3            $240
Physician.......................................................             180               1             180
Counselor.......................................................              34               1              34
Social Worker...................................................              45               1              45
Registered Nurse................................................              60               2             120
                                                                 -----------------------------------------------
    Totals......................................................  ..............               8             619
----------------------------------------------------------------------------------------------------------------

    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 
healthcare 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 final rule, the IDG for these hospices will need to 
accomplish the same tasks as described earlier for inpatient hospices 
to ensure that these policies and procedures comply with the 
requirements.
    We estimate that each hospice's compliance with this requirement 
will require 9 burden hours at a cost of $699. Therefore, based on that 
estimate, all 3,989 hospices that provide care to patients in their 
homes to comply with this requirement will require 35,901 burden hours 
(9 burden hours for each hospice x 3,989 hospices) at a cost of 
$2,788,311 ($699 estimated cost for each hospice x 3,989 hospices).
    Thus, we estimate that development of emergency preparedness 
policies and procedures for all 4,401 hospices will require 39,197 
burden hours at a cost of $3,043,339.

         Table 21--Total Cost Estimate for an Outpatient Hospice To Develop New Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $80               4            $320
Physician.......................................................             180               1             180
Counselor.......................................................              34               1              34
Social Worker...................................................              45               1              45
Registered Nurse................................................              60               2             120
                                                                 -----------------------------------------------
    Totals......................................................  ..............               9             699
----------------------------------------------------------------------------------------------------------------

    Section 418.113(c) will require a hospice to develop and maintain 
an emergency preparedness communication plan that complied with both 
federal and state law. Hospices will also have to review and update 
their plans at least annually. The communication plan will 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 (Sec.  418.110(c)), it 
is standard practice for healthcare 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 
healthcare 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 
will 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 proposed requiring for hospice communication plans.
    The burden associated with complying with this requirement will 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 will require only the involvement of the hospice's 
administrator. Thus, for each hospice, we estimate that complying with 
this requirement will require 3 burden hours at a cost of $240. 
Therefore, based on that estimate, compliance with this requirement for 
all 4,401 hospices will require 13,203 burden hours (3 burden hours for 
each hospice x 4,401 hospices) at a cost of $1,056,240 ($240 estimated 
cost for each hospice x 4,401 hospices).

[[Page 63945]]



                   Table 22--Total Cost Estimate for a Hospice To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $80               3            $240
                                                                 -----------------------------------------------
    Totals......................................................  ..............               3             240
----------------------------------------------------------------------------------------------------------------

    Section 418.113(d) will require each hospice to develop and 
maintain an emergency preparedness training and testing program that 
will be reviewed and updated at least annually. Section 418.113(d)(1) 
will 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 will also have to ensure that their employees 
could demonstrate knowledge of their emergency procedures. Thereafter, 
the hospice will have to provide emergency preparedness training at 
least annually. Hospices will 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 (Sec.  418.78(a)). In addition, inpatient hospices 
must periodically review and rehearse their disaster preparedness plans 
with their staff, including non-employee staff (Sec.  
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 final rule, all hospices 
will need to review their current training programs and compare their 
contents to their updated emergency preparedness plans, policies and 
procedures, and communications plans. Hospices will 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 previously discussed requirements 
will 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 will require the involvement of a 
registered nurse. We expect that the registered nurse will 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 will require 
6 burden hours at a cost of $360. Based on this estimate, compliance by 
all 4,401 hospices will require 26,406 burden hours (6 burden hours for 
each hospice x 4,401 hospices) at a cost of $1,584,360 ($360 estimated 
cost for each hospice x 4,401 hospices). We are proposing that hospices 
also be required to review and update their emergency preparedness 
training programs at least annually.

                    Table 23--Total Cost Estimate for a Hospice To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Registered Nurse................................................             $60               6            $360
                                                                 -----------------------------------------------
    Totals......................................................  ..............               6             360
----------------------------------------------------------------------------------------------------------------

    Section 418.113(d)(2) will require hospices to participate in a 
full-scale exercise at least annually. Hospices are also required to 
participate in one additional testing exercise of their choice at least 
annually. Hospices will 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 will need to develop scenarios 
for their drills and exercises. A hospice also will have to develop the 
required documentation.
    Hospices will 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 
testing exercises and emergency events will be new requirements for all 
hospices.
    The associated burden will be the time and effort necessary for a 
hospice to comply with these requirements. We expect that complying 
with these requirements will require the involvement of a registered 
nurse. We expect that the registered nurse will develop the necessary 
documentation and the scenarios for the drills and exercises. We 
estimate that these tasks will require 4 burden hours at an estimated 
cost of $240. Based on this estimate, in order for all 4,401 hospices 
to comply with these requirements, it will require 17,604 burden hours 
(4 burden hours for each hospice x 4,401 hospices) at a cost of 
$1,056,240 ($240 estimated cost for each hospice x 4,401 hospices).
    Thus, for all 4,401 hospices to comply with all of the requirements 
in Sec.  418.113, it will require an estimated 265,858 burden hours at 
a cost of $19,964,108.
    Comment: A commenter expressed that we underestimated the burden 
and additional cost for hospices to comply with these requirements 
since hospice providers will be fairly new to many of these standards. 
The commenter

[[Page 63946]]

indicated that hospices have not typically been participants in local, 
state, or federal emergency preparedness and response plans, so they 
will have to work even harder than other providers to build 
connections. The commenter suggested that CMS re-evaluate the burden 
estimates in the COI section for hospices.
    Response: We agree that hospices may not be typically involved in 
local, state, or federal emergency planning, however, as we stated, it 
is standard practice for healthcare providers to plan for common 
emergencies, such as fires, power outages, and storms. We expect that 
hospices already have some type of emergency or disaster plan, 
therefore we assigned burden based on the principle that each hospice 
will need to review its current emergency plan to ensure that it 
addressed the risks identified in its risk assessment and complies with 
the requirements. We also 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 will 
affect the hospice's ability to provide care'' (42 CFR 
418.110(c)(1)(ii)). Given these current CoPs, we believe that the 
burden estimates for hospices are appropriate.

                    Table 24--Total Cost Estimate for a Hospice To Conduct Testing Exercises
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Registered Nurse................................................             $60               4            $240
                                                                 -----------------------------------------------
    Totals......................................................  ..............               4             240
----------------------------------------------------------------------------------------------------------------


      Table 25--Burden Hours and Cost Estimates for All 4,401 Hospices To Comply With the ICRs in Sec.   418.113 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                                                         Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      Respondents   Responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   418.113(a) (outpatient).....  0938-New..............         3,989        3,989            8       31,912           **     2,469,191    2,469,191
Sec.   418.113(a)(1) (inpatient)...  0938-New..............           412          412           10        4,120           **       312,708      312,708
Sec.   418.113(a)(1) (outpatient)..  0938-New..............         3,989        3,989           12       47,868           **     3,586,111    3,586,111
Sec.   418.113(a)(1)-(4)             0938-New..............           412          412           14        5,768           **       477,508      477,508
 (inpatient).
Sec.   418.113(a)(1)-(4)             0938-New..............         3,989        3,989           20       79,780           **     6,378,411    6,378,411
 (outpatient).
Sec.   418.113(b) (inpatient)......  0938-New..............           412          412            8        3,296           **       255,028      255,028
Sec.   418.113(b) (outpatient).....  0938-New..............         3,989        3,989            9       35,901           **     2,788,311    2,788,311
Sec.   418.113(c)..................  0938-New..............         4,401        4,401            3       13,203           **     1,056,240    1,056,240
Sec.   418.113(d)(1)...............  0938-New..............         4,401        4,401            6       26,406           **     1,584,360    1,584,360
Sec.   418.113(d)(2)...............  0938-New..............         4,401        4,401            4       17,604           **     1,056,240    1,056,240
                                                            --------------------------------------------------------------------------------------------
    Totals.........................  ......................         8,802       30,395  ...........      265,858  ............  ...........   19,964,108
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 25.

F. ICRs Regarding Emergency Preparedness (Sec.  441.184)

    Section 441.184(a) will require Psychiatric Residential Treatment 
Facilities (PRTFs) to develop and maintain emergency preparedness plans 
and review and update those plans at least annually. We proposed that 
these plans meet the requirements listed at Sec.  441.184(a)(1) through 
(4).
    Section Sec.  441.184(a)(1) will require each PRTF to develop a 
documented, facility-based and community-based risk assessment that 
will 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 healthcare 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 will comply with all of our requirements. Therefore, 
we expect that all PRTFs will have to review and revise their current 
risk assessments.
    We do not designate 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 will 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 will require the 
involvement of the PRTF's administrator, a psychiatric registered 
nurse, and a clinical social worker. We expect that all of these 
individuals will 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 will 
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 will 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 will 
require 8 burden hours at a cost of $544. There are currently 377 
PRTFs. Therefore, based on that estimate, compliance by all PRTFs will 
require 3,016 burden hours (8 burden hours for each PRTF x 377 PRTFs) 
at a cost of $205,088 ($544 estimated cost for each PRTF x 377 PRTFs).

[[Page 63947]]



                      Table 26--Total Cost Estimate for a PRTF To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $93               2            $186
Social Worker...................................................              51               2             102
Registered Nurse................................................              64               4             256
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8             544
----------------------------------------------------------------------------------------------------------------

    After conducting the risk assessment, Sec.  441.184(a)(1) through 
(4) will require PRTFs to develop and maintain an emergency 
preparedness plan. Although it is standard practice for healthcare 
facilities to have some type of emergency preparedness plan, all PRTFs 
will need to review their current plans and compare them to their risk 
assessments. Each PRTF will 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 will be involved in developing the 
emergency preparedness plan. However, we expect it will require 
substantially more time to complete the plan than the risk assessment. 
We expect that the psychiatric nurse will be the most heavily involved 
in reviewing and developing the PRTF's emergency preparedness plan. We 
also expect that a clinical social worker will 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 will 
require 12 burden hours at a cost of $858. Thus, we estimate that it 
will require 4,524 burden hours (12 burden hours for each PRTF x 377 
PRTFs) for all PRTFs to comply with this requirement at a cost of 
$323,466 ($858 estimated cost per PRTF x 377 PRTFs).

               Table 27--Total Cost Estimate for a PRTF To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $93               4            $372
Social Worker...................................................              51               2             102
Registered Nurse................................................              64               6             384
                                                                 -----------------------------------------------
    Total.......................................................  ..............              12             858
----------------------------------------------------------------------------------------------------------------

    The PRTFs also will be required to review and update their 
emergency preparedness plans at least annually. However, under the 
current CoPs, PRTFs are not required to develop an emergency 
preparedness plan and as such, there is no requirement for an annual 
review of the plan. Therefore, we will analyze the burden from this 
requirement for all PRTFs.
    Based on our experience with PRTFs, we estimate that an additional 
burden will be associated with reviewing the plan at least annually and 
we anticipate that the same staff that will be involved with developing 
the emergency preparedness plan will also be involved in the annual 
review and update of the plan. The staff would include the 
administrator, clinical social worker, and psychiatric registered 
nurse. We estimate that for each PRTF to comply with this requirement 
will require 4 burden hours at an estimated cost of $272. Thus, we 
estimate that it will require 1,508 burden hours (4 burden hours for 
each PRTF x 377 PRTFs) for all PRTFs to comply with this requirement at 
a cost of $130,288 ($272 estimated cost per PRTF x 377 PRTFs).

          Table 28--Total Cost Estimate for a PRTF To Review and Update an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $93               1             $93
Social Worker...................................................              51               1              51
Registered Nurse................................................              64               2             128
                                                                 -----------------------------------------------
    Total.......................................................  ..............               4             272
----------------------------------------------------------------------------------------------------------------

    Section 441.184(b) will require each PRTF to develop and implement 
emergency preparedness policies and procedures, based on their 
emergency plan set forth in paragraph (a), the risk assessment at 
paragraph (a)(1), and the communication plan at paragraph (c). We also 
proposed requiring PRTFs to review and update these policies and 
procedures at least annually. At a minimum, we will 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 will 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 
will be involved in reviewing and revising the policies and procedures 
and, if needed, developing new policies and procedures. We estimate 
that it will require 9 burden hours at a cost of $663 for each PRTF to 
comply with this requirement. Based on this estimate, it

[[Page 63948]]

will require 3,393 burden hours (9 burden hours for each PRTF x 377 
PRTFs) for all PRTFs to comply with this requirement at a cost of 
$249,951 ($6632 estimated cost per PRTF x 377 PRTFs).

                   Table 29--Total Cost Estimate for a PRTF To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $93               3            $279
Registered Nurse................................................              64               6             384
                                                                 -----------------------------------------------
    Total.......................................................  ..............               9             663
----------------------------------------------------------------------------------------------------------------

    Section 441.184(c) will require each PRTF to develop and maintain 
an emergency preparedness communication plan that complied with both 
federal and state law. PRTFs also will have to review and update these 
plans at least annually. The communication plan will 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 healthcare 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 healthcare 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 will need to review and, if 
needed, revise their plans.
    Based on our experience with PRTFs, we anticipate that satisfying 
these requirements will 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 will 
require 5 burden hours at a cost of $378. Based on that estimate, for 
all PRTFs to comply will require 1,885 burden hours (5 burden hours for 
each PRTF x 377 PRTFs) at a cost of $142,506 ($378 estimated cost for 
each PRTF x 377 PRTFs).

                    Table 30--Total Cost Estimate for a PRTF To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $93               2            $186
Registered Nurse................................................              64               3             192
                                                                 -----------------------------------------------
    Total.......................................................  ..............               5             378
----------------------------------------------------------------------------------------------------------------

    Section 441.184(d) will require PRTFs to develop and maintain 
emergency preparedness training programs and review and update those 
programs at least annually. Section 441.184(d)(1) will 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 
will also have to ensure that their staff could demonstrate knowledge 
of the emergency procedures. Thereafter, the PRTF will 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 
will 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 will require the 
involvement of a psychiatric registered nurse. We expect that the 
psychiatric registered nurse will review the PRTF's current training 
program; determine what tasks will need to be performed and what 
materials will need to be developed; and develop the necessary 
materials. We estimate that for each PRTF to comply with the 
requirements in this section will require 10 burden hours at a cost of 
$640. Based on this estimate, for all PRTFs to comply with this 
requirement will require 3,770 burden hours (10 burden hours for each 
PRTF x 377 PRTFs) at a cost of $241,280 ($640 estimated cost for each 
PRTF x 377 PRTFs).

                     Table 31--Total Cost Estimate for a PRTF To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Registered Nurse................................................             $64              10            $640
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10             640
----------------------------------------------------------------------------------------------------------------

    Section 441.184(d)(2) will require PRTFs to participate in a full-
scale exercise at least annually. PRTFs are also required to 
participate in one additional testing exercise of their choice at least 
annually. PRTFs will also have to analyze their responses to and 
maintain documentation of all drills, tabletop exercises, and emergency

[[Page 63949]]

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 will be exempt from 
engaging in a community or a full-scale exercise for 1 year following 
the onset of the actual emergency event. To comply with this 
requirement, PRTFs will need to develop scenarios for each drill and 
exercise and the documentation necessary to record and analyze testing 
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 testing exercises and 
emergency events. However, we do not expect that all PRTFs are 
conducting two testing exercises 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 
will develop the scenarios for the testing exercises and the 
accompanying documentation. We estimate that for each PRTF to comply 
with the requirements in this section will require 3 burden hours at a 
cost of $192. We estimate that for all PRTFs to comply will require 
1,131 burden hours (3 burden hours for each PRTF x 377 PRTFs) at a cost 
of $72,384 ($192 estimated cost for each PRTF x 377 PRTFs).

                      Table 32--Total Cost Estimate for a PRTF To Conduct Testing Exercises
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Registered Nurse................................................             $64               3            $192
                                                                 -----------------------------------------------
    Total.......................................................  ..............               3             192
----------------------------------------------------------------------------------------------------------------

    Based on the previous analysis, for all 377 PRTFs to comply with 
the ICRs in this final rule will require 17,719 burden hours at a cost 
of $1,234,675.

    Table 33--Burden Hours and Cost Estimates for All 377 PRTFs To Comply With the ICRs Contained in Sec.   441.184 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                                                         Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      Respondents   Responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   441.184(a)..................  0938-New..............           377          377            4        1,508          * *       130,288      130,288
Sec.   441.184(a)(1)...............  0938-New..............           377          377            8        3,016          * *       205,088      205,088
Sec.   441.184(a)(1)-(4)...........  0938-New..............           377          377           12        4,524          * *       323,466      323,466
Sec.   441.184(b)..................  0938-New..............           377          377            9        3,393          * *       249,951      249,951
Sec.   441.184(c)..................  0938-New..............           377          377            5        1,885          * *       142,506      142,506
Sec.   441.184(d)(1)...............  0938-New..............           377          377           10        3,770          * *       241,280      241,280
Sec.   441.184(d)(2)...............  0938-New..............           377          377            3        1,131          * *        72,384       72,384
                                    --------------------------------------------------------------------------------------------------------------------
    Totals.........................  ......................           377        2,639  ...........       19,277  ............  ...........    1,364,963
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 33.

G. ICRs Regarding Emergency Preparedness (Sec.  460.84)

    Section 460.84(a) will 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 proposed that each plan must meet the requirements listed 
at Sec.  460.84(a)(1) through (4).
    Section 460.84(a)(1) will 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 will 
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 requirements. Therefore, we expect 
that all 119 PACE organizations will have to review, revise, and update 
their current risk assessments.
    We have not designated any specific process or format for PACE

[[Page 63950]]

organizations to use in conducting their risk assessments because we 
believe that they will be able to determine the best way for their 
facilities to accomplish this task. However, we expect that they will 
include representation or input from all of their major departments. 
Based on our experience with PACE organizations, we expect that 
conducting the risk assessment will 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 will either attend an initial meeting or 
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 will 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 will 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 
will 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 will require 14 burden hours at a cost of 
$1,105. For all 119 PACE organizations to comply with this requirement 
will require an estimated 1,666 burden hours (14 burden hours for each 
PACE organization x 119 PACE organizations) at a cost of $131,495 
($1,105 estimated cost for each PACE organization x 119 PACE 
organizations).

                      Table 34--Total Cost Estimate for a PACE To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Program Director................................................            $110               3            $330
Medical Director................................................             182               1             182
Home Care Coordinator...........................................              64               4             256
Registered Nurse/Quality Improvement............................              64               4             256
Social Worker...................................................              55               1              55
Driver..........................................................              26               1              26
                                                                 -----------------------------------------------
    Total.......................................................  ..............              14           1,105
----------------------------------------------------------------------------------------------------------------

    After conducting a risk assessment, PACE organizations will 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 will be an essential 
component of such a comprehensive, systemic operational plan. However, 
this regulatory requirement does not guarantee that all PACE 
organizations have developed a plan that complies with our 
requirements.
    Thus, we expect that all PACE organizations will need to review 
their current plans and compare them to their risk assessments. PACE 
organizations will 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 will be involved in developing the emergency preparedness 
plan. However, we expect that it will require more time to complete the 
plan. We expect that the quality improvement nurse will 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 will review the current plan, 
provide comments, and assist the quality improvement nurse in 
developing the final plan. Other staff members will work only on the 
sections of the plan that will be relevant to their areas of 
responsibility.
    We estimate that for each PACE organization to comply with the 
requirement for an emergency preparedness plan will require 23 burden 
hours at a cost of $1,798. We estimate that for all PACE organizations 
to comply will require 2,737 burden hours (23 burden hours for each 
PACE Organization x 119 PACE organizations) at a cost of $213,962 
($1,798 estimated cost for each PACE organization x 119 PACE 
organizations).

                      Table 35--Total Cost Estimate for a PACE To Develop an Emergency Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Program Director................................................            $110               4            $440
Medical Director................................................             182               2             364
Home Care Coordinator...........................................              64               7             448
Registered Nurse/Quality Improvement............................              64               6             384
Social Worker...................................................              55               2             110
Driver..........................................................              26               2              52
                                                                 -----------------------------------------------
    Total.......................................................  ..............              23           1,798
----------------------------------------------------------------------------------------------------------------

    The PACE organizations will 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

[[Page 63951]]

periodically. Therefore, we believe compliance with this requirement 
will constitute a usual and customary business practice for PACE 
organizations and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA 5 CFR 1320.3(b)(2).
    Section 460.84(b) will require each PACE organization to develop 
and implement emergency preparedness policies and procedures based on 
the emergency plan set forth in paragraph (a), the risk assessment at 
paragraph (a)(1), and the communication plan at paragraph (c). It will 
also require PACE organizations to review and update these policies and 
procedures at least annually. At a minimum, we will 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 (Sec.  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 will comply with our requirements.
    The burden associated with the requirements will 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 will be 
primarily responsible for reviewing, revising, and if needed, 
developing any new policies and procedures needed to comply with our 
requirements. We estimate that for each PACE organization to comply 
with our requirements will require 12 burden hours at a cost of $860. 
Therefore, based on this estimate, for all PACE organizations to comply 
will require 1,428 burden hours (12 burden hours for each PACE 
organization x 119 PACE organizations) at a cost of $102,340 ($860 
estimated cost for each PACE organization x 119 PACE organizations).

                   Table 36--Total Cost Estimate for a PACE To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Program Director................................................            $110               2            $220
Home Care Coordinator...........................................              64               5             320
Registered Nurse/Quality Improvement............................              64               5             320
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................................................  ..............              12             860
----------------------------------------------------------------------------------------------------------------

    We proposed 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 will constitute a usual and customary 
business practice and will not be subject to the PRA in accordance with 
the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 460.84(c) will require each PACE organization to develop 
and maintain an emergency preparedness communication plan that complied 
with both federal and state law. Each PACE organization will 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 will include at least some of our requirements. In addition, it 
is standard practice in the healthcare 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 healthcare 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 will need to review its current 
plan and revise or, in some cases, develop new sections to comply with 
our requirements.
    Based on our experience with PACE organizations, we expect that the 
home care coordinator and the quality assurance nurse will 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 requirements will require 7 burden 
hours at a cost of $448. Therefore, based on this estimate, for all 
PACE organizations to comply with this requirement will require 833 
burden hours (7 burden hours for each PACE organization x 119 PACE 
organizations) at a cost of $53,312 ($448 estimated cost for each PACE 
organization x 119 PACE organizations).

                    Table 37--Total Cost Estimate for a PACE To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Home Care Coordinator...........................................             $64               4            $256
Registered Nurse/Quality Improvement............................              64               3             192
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................................................  ..............               7             448
----------------------------------------------------------------------------------------------------------------


[[Page 63952]]

    Each PACE organization must also review and update its emergency 
preparedness communication plan at least annually. We believe that PACE 
organizations are already reviewing and updating their emergency 
preparedness communication plans periodically. Thus, we believe 
compliance with this requirement will constitute a usual and customary 
business practice for PACE organizations and will not be subject to the 
PRA in accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    Section 460.84(d) will require PACE organizations to develop and 
maintain emergency preparedness training and testing programs and 
review and update those programs at least annually. We proposed that 
each PACE organization will have to meet the requirements listed at 
Sec.  460.84(d)(1) and (2).
    Section 460.84(d)(1) will 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 will also have to ensure that their staff 
could demonstrate knowledge of the emergency procedures. Thereafter, 
PACE organizations will 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 will be in 
compliance with our requirements. Thus, each PACE organization will 
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 will also 
need to revise and, in some cases, develop new sections to ensure that 
its emergency preparedness training program complied with our 
requirements. We expect that the quality assurance nurse will review 
all elements of the PACE organization's training program and determine 
what tasks will need to be performed and what materials will need to be 
developed to comply with our requirements. We expect that the home care 
coordinator will 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 requirements will require 12 burden 
hours at a cost of $768. Therefore, it will require an estimated 1,428 
burden hours (12 burden hours for each PACE organization x 119 PACE 
organizations) to comply with this requirement at a cost of $91,392 
($768 estimated cost for each PACE organization x 119 PACE 
organizations).

                     Table 38--Total Cost Estimate for a PACE To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Home Care Coordinator...........................................             $64               3            $192
Registered Nurse/Quality Improvement............................              64               9             576
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................................................  ..............              12             768
----------------------------------------------------------------------------------------------------------------

    The PACE organizations will 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, 
we believe compliance with this requirement will constitute a usual and 
customary business practice for PACE organizations and will not be 
subject to the PRA in accordance with the implementing regulations of 
the PRA at 5 CFR 1320.3(b)(2).
    Section 460.84(d)(2) will require PACE organizations to participate 
in a full-scale exercise at least annually. They will also be required 
to conduct one additional exercise of their choice at least annually. 
PACE organizations will also be required to analyze their responses to, 
and maintain documentation of, all testing 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 will be exempt from engaging in a community or individual, 
facility-based full-scale exercise for 1 year following the onset of 
the actual event. To comply with these requirements, PACE organizations 
will need to develop a specific scenario for each drill and exercise. 
The PACE organizations will also have to develop the documentation 
necessary for recording and analyzing their response to all testing 
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 will 
develop a scenario for and document the testing. However, this does not 
ensure that all PACE organizations will be in compliance with all of 
our requirements, especially the requirement for conducting a paper-
based, tabletop exercise; performing a community-based full-scale 
exercise; and using different scenarios for the testing exercises.
    The 119 PACE organizations will be required to develop scenarios 
for testing exercises and the documentation necessary to record and 
analyze their response to all 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 will develop the required documentation. We expect the quality 
improvement nurse will spend more time on these activities than the 
healthcare coordinator. We estimate that this activity will require 5 
burden hours for each PACE organization at a cost of $320. We estimate 
that for all PACE organizations to comply with these requirements will 
require 595 burden hours (5 burden hours for each PACE organization x 
119 PACE organizations) at a cost of $38,080 ($595 estimated cost for 
each PACE organization x 119 PACE organizations).

[[Page 63953]]



                      Table 39--Total Cost Estimate for a Pace To Conduct Testing Exercises
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Home Care Coordinator...........................................             $64               4            $256
Registered Nurse/Quality Improvement............................              64               1              64
                                                                 -----------------------------------------------
    Total.......................................................  ..............               5             320
----------------------------------------------------------------------------------------------------------------


   Table 40--Burden Hours and Cost Estimates for All 119 Pace Organizations To Comply With the ICRs Contained in Sec.   460.84 Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                                                         Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      Respondents   Responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   460.84(a)(1)................  0938--New.............           119          119           14        1,666           **       131,495      131,495
Sec.   460.84(a)(1)-(4)............  0938--New.............           119          119           23        2,737           **       213,962      213,962
Sec.   460.84(b)...................  0938--New.............           119          119           12        1,428           **       102,340      102,340
Sec.   460.84(c)...................  0938--New.............           119          119            7          833           **        53,312       53,312
Sec.   460.84(d)(1)................  0938--New.............           119          119           12        1,428           **        91,392       91,392
Sec.   460.84(d)(2)................  0938--New.............           119          119            5          595           **        38,080       38,080
                                    --------------------------------------------------------------------------------------------------------------------
    Totals.........................  ......................           119          714  ...........        8,687  ............  ...........      630,581
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 40.

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

    Section 482.15(a) will require hospitals to develop and maintain 
emergency preparedness plans. We proposed 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 final rule's 
publication. In addition, some hospitals may have chosen to be 
accredited by more than one accrediting organization.
    There are approximately 4,793 Medicare-certified hospitals. This 
includes 121 critical access hospitals (CAHs) that have rehabilitation 
or psychiatric distinct part units (DPUs) as of June 30, 2016 CASPER 
data. 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 4,793 hospitals reported in CMS' CASPER data system, 
approximately 3,913 are accredited hospitals and the remainder are 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/HFAP, and 
DNV GL.
    Accreditation can substantially affect the burden a hospital will 
sustain under this final rule. The Joint Commission accredits 3,448 
hospitals. Many of our requirements are similar or virtually identical 
to the standards, rationales, and elements of performance (EPs) 
required for TJC accreditation. TJC standards, rationales, and elements 
of performance (EPs) are on the TJC Web site at http://www.jointcommission.org/.
    The AOA/HFAP and DNV GL 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 AOA/HFAP-accredited 
hospitals and the DNV GL-accredited hospitals in with the hospitals 
that are not accredited. Therefore, unless indicated otherwise, we have 
analyzed the burden for the 3,448 TJC-accredited hospitals separately 
from the remaining 1,345 non TJC-accredited hospitals (4,793 hospitals-
3,448 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 will 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 requirements 
and that any additional tasks necessary to comply will be minimal. 
Therefore, for TJC-accredited hospitals, the risk assessment 
requirement will constitute a usual and customary business practice and 
will not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 482.15(a)(1) will 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

[[Page 63954]]

disasters. However, many may not have thoroughly documented this 
activity or performed as thorough a risk assessment as needed to comply 
with our 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 will obtain input from all of 
their major departments when performing a risk assessment. Based on our 
experience, we expect that conducting a risk assessment will 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 will 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 will 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 will spend more time reviewing the risk 
assessment than most of the other individuals.
    We estimate that the risk assessment will require 34 burden hours 
to complete at a cost of $4,232 for each non-TJC accredited hospital. 
There are approximately 1,345 non TJC-accredited hospitals. Therefore, 
it will require an estimated 45,730 burden hours (34 burden hours for 
each non TJC-accredited hospitals x 1,345 non TJC-accredited hospitals) 
for all non TJC-accredited hospitals to comply at a cost of $5,692,040 
($4,232 estimated cost for each non TJC-hospital x 1,345 non TJC-
accredited hospitals).

    Table 41--Total Cost Estimate for a Non-TJC Accredited Hospital To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $172               4            $688
Risk Management Director........................................             104               8             832
Chief Medical Officer/Medical Director..........................             199               2             398
Chief of Surgery................................................             231               2             462
Director of Nursing.............................................             104               3             312
Pharmacy Director...............................................             142               3             426
Facilities Director.............................................             104               3             312
Health Information Services Director............................             104               2             208
Security Manager................................................             104               2             208
Community Relations Manager.....................................             107               2             214
Food Services Manager...........................................              70               2             140
Medical Secretary...............................................              32               1              32
                                                                 -----------------------------------------------
    Total.......................................................  ..............              34           4,232
----------------------------------------------------------------------------------------------------------------

    Section 482.15(a)(1) through (4) will require hospitals to develop 
and maintain emergency preparedness plans. We expect that all hospitals 
will compare their risk assessments to their emergency plans and revise 
and, if necessary, develop new sections for their plans. TJC-accredited 
hospitals must develop and maintain written Emergency Operations Plans 
(EOPs) (CAMH, Standard EC.4.12, EP 1, CAMH Refreshed Care, January 
2008, p. EC-13b). The EOP should describe an ``all-hazards'' approach 
to coordinating six critical areas: Communications, resources and 
assets, safety and security, staff roles and responsibilities, 
utilities, and patient clinical and support activities during 
emergencies (CAMH, Standard EC.4.13-EC.4.18, CAMH Refreshed Core, 
January 2008, pp. EC-13b-EC-13g). Hospitals also must include in their 
EOP ``[r]esponse strategies and actions to be activated during the 
emergency'' and ``[r]ecovery strategies and actions designed to help 
restore the systems that are 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 final rule. If a TJC-accredited hospital needed to complete 
additional tasks to comply with the requirement, we believe that the 
burden will be negligible. Therefore, for TJC-accredited hospitals, 
this requirement will constitute a usual and customary business 
practice and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA at 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 requirements. Thus, it will 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 will be 
involved in developing the emergency preparedness plan. However, we

[[Page 63955]]

estimate that it will require substantially more time to complete an 
emergency preparedness plan. We estimate that complying with this 
requirement will require 62 burden hours at a cost of $7,408 for each 
non TJC-accredited hospital. There are approximately 1,345 non TJC-
accredited hospitals. Therefore, based on this estimate, it will 
require 83,390 burden hours for all non TJC-accredited hospitals (62 
burden hours for each non TJC-accredited hospitals x 1,345 non TJC-
accredited hospitals) to complete an emergency preparedness plan at a 
cost of $9,963,760 ($7,408 estimated cost for each non TJC-accredited 
hospital x 1,345 non TJC-accredited hospitals).

          Table 42--Total Cost Estimate for a Non-TJC Accredited Hospital To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $172               4            $688
Risk Management Director........................................             104              20           2,080
Chief Medical Officer/Medical Director..........................             199               3             597
Chief of Surgery................................................             231               3             693
Director of Nursing.............................................             104               6             624
Pharmacy Director...............................................             142               5             710
Facilities Director.............................................             104               6             624
Health Information Services Director............................             104               3             312
Security Manager................................................             104               6             624
Community Relations Manager.....................................             107               2             214
Food Services Manager...........................................              70               3             210
Medical Secretary...............................................              32               1              32
                                                                 -----------------------------------------------
    Total.......................................................  ..............              62           7,408
----------------------------------------------------------------------------------------------------------------

    Under this final rule, a hospital also will 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, we believe compliance with this 
requirement will constitute a usual and customary business practice for 
hospitals and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Under Sec.  482.15(b), we will require each hospital to develop and 
implement emergency preparedness policies and procedures based on its 
emergency plan set forth in paragraph (a), the risk assessment at 
paragraph (a)(1), and the communication plan at paragraph (c). We will 
also require hospitals to review and update these policies and 
procedures at least annually. At a minimum, we will require that the 
policies and procedures address the requirements at Sec.  482.15(b)(1) 
through (8).
    We will 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 will 
then review, revise, and, if necessary, develop new policies and 
procedures that comply with our 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.'' The policies 
and procedures are to guide all patient care, including during and 
after emergencies (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 requirements. 
In addition to meeting TJC standards, hospitals are required to meet 
state and local and licensing requirements. Based on these 
requirements, hospitals have been operating within this framework in 
the delivery of patient care services. State and local laws require 
fire, emergency, and safety codes that have an impact on operations 
during an emergency or a disaster. As discussed later, many of the 
requirements in Sec.  482.15(b) has a corresponding requirement in the 
TJC hospital accreditation standards. Hence, we will discuss each 
section individually.
    Section 482.15(b)(1) will 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 will be in compliance with our 
provision of subsistence requirements in Sec.  482.15(b)(1).
    Section 482.15(b)(2) will require hospitals to have policies and 
procedures to track the location of on-duty staff and sheltered 
patients in the hospital's care during 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 
will be in compliance with Sec.  482.15(b)(2).
    Section 482.15(b)(3) will 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). Section 482.15(b)(3) also will 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 will be in compliance with most of 
the requirements in Sec.  482.15(b)(3). However, we do not believe 
these requirements will ensure

[[Page 63956]]

compliance with the requirement that the hospital establish policies 
and procedures for staff responsibilities.
    Section 482.15(b)(4) will 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 will be in compliance with our shelter in place 
requirement in Sec.  482.15(b)(4).
    Section 482.15(b)(5) will 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 will 
be in compliance with the requirements we proposed in Sec.  
482.15(b)(5).
    Section 482.15(b)(6) will 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 healthcare 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 requirements, we do not believe these 
requirements will ensure compliance with all requirements in in Sec.  
482.15(b)(6).
    Section 482.15(b)(7) will require hospitals to have policies and 
procedures that will 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 healthcare organizations 
(CAMH, Standard EC.4.14, EPs 7 and 8, p. EC-13d). However, we will not 
expect TJC-accredited hospitals to be substantially in compliance with 
the requirements we proposed in Sec.  482.15(b)(7) based on compliance 
with TJC accreditation standards alone.
    Section 482.15(b)(8) will 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 in accordance with 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 will be in compliance with the requirements we 
proposed in Sec.  482.15(b)(8).
    In summary, we expect that TJC-accredited hospitals have developed 
and are maintaining policies and procedures that will comply with the 
requirements in Sec.  482.15(b), except for 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 will need to make to comply with the remaining 
requirements will not impose a burden above that incurred as part of 
usual and customary business practices. Thus, with the exception of the 
requirements set out at Sec.  482.15(b)(3), (6), and (7), we believe 
the requirements constitute usual and customary business practices and 
will not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2).
    The burden associated with Sec.  482.15(b)(3), (6), and (7) will be 
the resources required to develop written policies and procedures that 
comply with the requirements. We expect that the risk management 
director will 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 will make revisions or draft new policies 
and procedures based on the administrator's recommendation. The 
appropriate parties will then need to compile and disseminate these new 
policies and procedures. We estimate that complying with these 
requirements will require 17 burden hours for each TJC-accredited 
hospital at a cost of $2,061. For all 3,448 TJC-accredited hospitals to 
comply with these requirements will require an estimated 58,616 burden 
hours (17 burden hours for each TJC-accredited hospital x 3,448 TJC-
accredited hospitals) at a cost of $7,106,328 ($2,061 estimated cost 
for each TJC-accredited hospital x 3,448 TJC-accredited hospitals).

         Table 43--Total Cost Estimate for a TJC-Accredited Hospital To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $172               2            $344
Risk Management Director........................................             104               4             416
Chief Medical Officer/Medical Director..........................             199               1             199

[[Page 63957]]

 
Chief of Surgery................................................             231               1             231
Director of Nursing.............................................             104               2             208
Pharmacy Director...............................................             142               1             142
Facilities Director.............................................             104               1             104
Health Information Services Director............................             104               1             104
Security Manager................................................             104               1             104
Community Relations Manager.....................................             107               1             107
Food Services Manager...........................................              70               1              70
Medical Secretary...............................................              32               1              32
                                                                 -----------------------------------------------
    Total.......................................................  ..............              17           2,061
----------------------------------------------------------------------------------------------------------------

    The 1,345 non TJC-accredited hospitals will 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 requirements 
into their policies and procedures. We expect that the risk management 
director will 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 
will spend more time reviewing the policies and procedures than most of 
the other individuals.
    We estimate that complying with this requirement will require 33 
burden hours for each non TJC-accredited hospital at an estimated cost 
of $3,831. Based on this estimate, for all 1,345 non TJC-accredited 
hospitals to comply with these requirements will require 44,385 burden 
hours (33 burden hours for each non TJC-accredited hospital x 1,345 non 
TJC-accredited hospitals) at a cost of $5,152,695 ($3,831 estimated 
cost for each non TJC-accredited hospital x 1,345 non TJC-accredited 
hospitals).

       Table 44--Total Cost Estimate for a Non TJC-Accredited Hospital To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $172               3            $516
Risk Management Director........................................             104              10           1,040
Chief Medical Officer/Medical Director..........................             199               1             199
Chief of Surgery................................................             231               1             231
Director of Nursing.............................................             104               6             624
Pharmacy Director...............................................             142               2             284
Facilities Director.............................................             104               3             312
Health Information Services Director............................             104               1             104
Security Manager................................................             104               3             312
Community Relations Manager.....................................             107               1             107
Food Services Manager...........................................              70               1              70
Medical Secretary...............................................              32               1              32
                                                                 -----------------------------------------------
    Total.......................................................  ..............              33           3,831
----------------------------------------------------------------------------------------------------------------

    In addition, we expect that there will be a burden as a result of 
Sec.  482.15(b)(7). Section 482.15(b)(7) will 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 will 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 will also sustain a burden related to developing the written 
agreements related to those arrangements.
    All 4,793 hospitals will 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 will have written agreements with two other hospitals 
and other providers. Based on our experience with hospitals, we expect 
that complying with this requirement will primarily require the 
involvement of the hospital's administrator and risk management 
director. We also expect that a hospital attorney will assist with 
drafting the agreements and reviewing those documents for any legal 
implications. We estimate that complying with this requirement will 
require 8 burden hours for each hospital at an estimated cost of 
$1,037. Thus, it will require an estimated 38,344 burden hours (8 
burden hours for each hospital x 4,793 hospitals) for all hospitals to 
comply with this requirement at a cost of $4,970,341 ($1,037 estimated 
cost for each hospital x 4,793 hospitals).

[[Page 63958]]



   Table 45--Total Cost Estimate for a Hospital, With Written Agreements With Other Hospitals or Providers, To
                                         Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $172               2            $344
Risk Management Director........................................             104               3             312
Attorney........................................................             127               3             381
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8           1,037
----------------------------------------------------------------------------------------------------------------

    Section 482.15(b) will 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, we believe 
compliance with this requirement will constitute a usual and customary 
business practice for both TJC-accredited and non TJC-accredited 
hospitals and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Section 
482.15(c) will require each hospital to develop and maintain an 
emergency preparedness communication plan that complied with both 
federal and state law. The plan will have to be reviewed and updated at 
least annually. The communication plan will 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 final rule, 
hospitals will 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 healthcare 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 healthcare providers to ensure 
continuity of care for patients. However, under this final rule, all 
hospitals will need to review and update their plans to ensure 
compliance with our requirements.
    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 healthcare 
organizations) . . .'' (CAMH, Standard EC.4.13, EP 12, p. EC-13c). 
Thus, we expect that that TJC-accredited hospitals will be in 
compliance with Sec.  482.15(c)(1) through (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 
will be in compliance with Sec.  482.15(c)(5) through (7). Therefore, 
we expect that TJC-accredited hospitals already have developed and are 
currently maintaining emergency communication plans that will satisfy 
the requirements contained in Sec.  482.15(c). Therefore, we believe 
compliance with this requirement will constitute a usual and customary 
business practice and will not be subject to PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Most, if not all, non TJC-accredited hospitals will be 
substantially in compliance with Sec.  482.15(c)(1) through (4). 
However, non TJC-accredited hospitals will 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 requirements in 
this section. We expect that this activity will 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 will require 10 burden hours at a cost 
of $1,111 for each of the 1,345 non TJC-accredited hospitals. 
Therefore, based on this estimate, for non TJC-accredited hospitals to 
comply with this requirement will require 13,450 burden hours (10 
burden hours for each non TJC-accredited hospital x 1,345 non TJC-
accredited hospitals) at a cost of $1,494,295 ($1,068 estimated cost 
for each non TJC-accredited hospital x 1,345 non TJC-accredited 
hospitals).

         Table 46--Total Cost Estimate for a Non TJC-Accredited Hospital To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $172               1            $172
Risk Management Director........................................             104               4             416
Director of Nursing.............................................             104               1             104
Facilities Director.............................................             104               1             104
Health Information Services Director............................             104               1             104
Security Manager................................................             104               1             104
Community Relations Manager.....................................             107               1             107
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10           1,111
----------------------------------------------------------------------------------------------------------------


[[Page 63959]]

    Section 482.15(c) also will require hospitals to review and update 
their emergency preparedness communication plans at least annually. We 
believe that hospitals are already reviewing and updating their 
emergency preparedness communication plans periodically. Therefore, we 
believe compliance with this requirement will constitute a usual and 
customary business practice and will not be subject to the PRA in 
accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    Section 482.15(d) will require hospitals to develop and maintain 
emergency preparedness training and testing programs and review and 
update those plans at least annually. The hospital will be required to 
meet the requirements in Sec.  482.15(d)(1) and (2).
    Section 482.15(d)(1) will require hospitals to provide initial and 
thereafter annual training on their emergency preparedness policies and 
procedures to all and new existing staff, individuals providing 
services under arrangement, and volunteers, consistent with their 
expected roles. Hospitals must also maintain documentation of all of 
this training.
    The burden for Sec.  482.15(d)(1) will 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 
will 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 will need to revise and, if necessary, 
develop new sections or material to ensure that their training programs 
comply with our requirements.
    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 will expect that an 
orientation to the hospital's EOP will 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 healthcare 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 will expect the additional burden to be negligible. Thus, 
for the TJC-accredited hospitals, the requirements will not be subject 
to the PRA in accordance with the implementing regulations of the PRA 
at 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 final rule, non TJC-accredited hospitals 
will need to compare their existing training programs with their risk 
assessments, emergency preparedness plans, policies and procedures, and 
communication plans. They also will need to revise, update, and, if 
necessary, develop new sections and new material for their training 
programs.
    There are many ways in which a hospital may develop a training 
program. For example, 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 healthcare 
associations and organizations. Hospitals could also participate in a 
local healthcare coalition, a partnership with other hospitals, 
healthcare facilities and local health departments to develop the 
necessary training. In addition, hospitals could develop partnerships 
with other hospitals and healthcare 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, because many hospitals have a hospital emergency 
manager and safety office, we anticipate that the training program 
would likely be developed using the hospital's own staff. It is our 
experience with hospitals that a majority of them conduct some type of 
preparedness activities and training and, as such, are most likely to 
have staff versed in these issues that can assist with training. 
Additionally, hospitals and other healthcare providers commonly 
participate in trainings that are provided by their local healthcare 
coalition, local and state public health and emergency management 
agencies conducting community based exercises (for example, American 
Red Cross). The estimation of a burden for these requirements is based 
on this assumption.
    Based on our experience with hospitals, we expect that complying 
with this requirement will require the involvement of the hospital 
administrator, the risk management director, a healthcare trainer, and 
administrative support staff. We estimate that it will require 40 
burden hours for each hospital to develop an emergency preparedness 
training program at a cost of $3,000 for each non TJC-accredited 
hospital. We estimate that it will require 53,800 burden hours (40 
burden hours for each non TJC-accredited hospital x 1,345 non TJC-
accredited hospitals) to comply with this requirement at a cost of 
$4,035,000 ($3,000 estimated cost for each hospital x 1,345 non TJC-
accredited hospitals).

          Table 47--Total Cost Estimate for a Non TJC-Accredited Hospital To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $172               2            $344
Risk Management Director........................................             104               6             624
Healthcare Trainer (Registered Nurse)...........................              68              28           1,904
Medical Secretary...............................................              32               4             128
                                                                 -----------------------------------------------
    Total.......................................................  ..............              40           3,000
----------------------------------------------------------------------------------------------------------------


[[Page 63960]]

    Section 482.15(d) will 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, we believe 
compliance with this requirement will constitute a usual and customary 
business practice and will not be subject to the PRA in accordance with 
the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Hospitals also will 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, we believe compliance with this requirement will constitute 
a usual and customary business practice for the hospitals and not be 
subject to the PRA in accordance with the implementing regulations of 
the PRA at 5 CFR 1320.3(b)(2).
    Section 482.15(d)(2) will also require hospitals to participate in 
a full-scale exercise and one additional exercise of their choice at 
least annually. Hospitals also will be required to analyze their 
responses to, and maintain documentation of, all exercises and 
emergency events. If a hospital experienced an actual emergency which 
required activation of its emergency plan, it will be exempt from the 
requirement for a community or individual, facility-based disaster 
drill for 1 year following the onset of the emergency (Sec.  
482.15(d)(2)(ii)). Thus, to satisfy the burden for these requirements, 
hospitals will need to develop a scenario for each exercise, as well as 
the documentation necessary for recording what happened. If a hospital 
participated in a full-scale exercise, it probably will not need to 
develop a scenario for that drill. However, for the purpose of 
determining the burden, we will assume that hospitals will need to 
develop at least two scenarios annually, one for each testing exercise 
requirement.
    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 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 testing exercises and have the documentation 
needed for the analysis of their responses. We expect that it will be a 
usual and customary business practice for the TJC-accredited hospitals 
to comply with the requirement to prepare scenarios for emergency 
preparedness testing exercises and to develop the necessary 
documentation. Thus, we believe compliance with this requirement will 
not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 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 drills and exercises held by their communities, counties, and 
states. A 2006 study of 678 hospitals found that 88 percent of the 
participating hospitals were engaged in community-wide emergency 
preparedness drills and exercises (Braun BI, Wineman NV, Finn NL, 
Barbera JA, Schmaltz SP, Loeb JM. Integrating hospitals into community 
emergency preparedness planning. Ann Intern Med. 2006 Jun;144(11):799-
811. PubMed PMID: 16754922.) We also expect that many of these 
hospitals have already developed the required documentation for 
recording the events, and analyzing their responses to, their testing 
exercises and emergency events. However, we do not believe that all 
non-TJC accredited hospitals will be in compliance with our 
requirements. Thus, we will analyze the burden for non TJC-accredited 
hospitals.
    The non TJC-accredited hospitals will be required to develop 
scenarios for the testing exercises and the documentation necessary to 
record and analyze their responses to the exercises and emergency 
events. Based on our experience with hospitals, we expect that the same 
individuals who developed the emergency preparedness training program 
will develop the scenarios for the testing exercises and the 
accompanying documentation. We expect that the healthcare trainer will 
spend more time developing the scenarios and documentation. Thus, for 
each of the 1,345 non TJC-accredited hospitals to comply with these 
requirements, we estimate that it will require 9 burden hours at a cost 
of $752. Based on this estimate, for all 1,345 non TJC-accredited 
hospitals to comply will require 12,105 burden hours (9 burden hours 
for each non TJC-accredited hospital x 1,345 non TJC-accredited 
hospitals) at a cost of $1,011,440 ($752 estimated cost for each non 
TJC-accredited hospital x 1,345 non TJC-accredited hospital).

               Table 48--Total Cost Estimate for a Non TJC-Accredited Hospital To Conduct Testing
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $172               1            $172
Risk Management Director........................................             104               2             208
Healthcare Trainer (RN).........................................              68               5             340
Medical Secretary...............................................              32               1              32
                                                                 -----------------------------------------------
    Total.......................................................  ..............               9             752
----------------------------------------------------------------------------------------------------------------


 Table 49--Burden Hours and Cost Estimates for All 4,793 Hospitals To Comply With the ICRS Contained in Sec.   482.15 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Total     Hourly labor
                                                                             Burden per     annual       cost of     Total labor cost
    Regulation section(s)      OMB  Control No.   Respondents   Responses     response      burden      reporting    of reporting ($)    Total cost ($)
                                                                              (hours)      (hours)         ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   482.15(a)(1)..........  0938--New.......         1,345        1,345           36       45,730           **        5,692,040.00       5,692,040.00
Sec.   482.15(a)(1)-(4)......  0938--New.......         1,345        1,345           62       83,390           **        9,963,760.00       9,963,760.00
Sec.   482.15(b).............  0938--New.......         3,448        3,448           17       58,616           **        7,106,328.00       7,106,328.00
(TJC-accredited).............

[[Page 63961]]

 
Sec.   482.15(b).............  0938--New.......         1,345        1,345           33       44,385           **        5,152,695.00       5,152,695.00
(Non TJC-accredited).........
Sec.   482.15(b)(7)..........  0938--New.......         4,793        4,793            8       38,344           **           4,970,341          4,970,341
Sec.   482.15(c).............  0938--New.......         1,345        1,345           10       13,450           **        1,494,295.00       1,494,295.00
Sec.   482.15(d)(1)..........  0938--New.......         1,345        1,345           40       53,800           **        4,035,000.00       4,035,000.00
Sec.   482.15(d)(2)..........  0938--New.......         1,345        1,345            9       12,105           **        1,011,440.00       1,011,440.00
                              --------------------------------------------------------------------------------------------------------------------------
    Totals...................  ................         9,586       16,311  ...........      349,820  ............  .................      39,425,899.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 49.

I. ICRs Regarding Condition of Participation: Emergency Preparedness 
for Transplant Centers (Sec.  482.78)

    As discussed in section II.I. of this final rule, we have revised 
our requirements for transplant centers. Section 482.78 will require 
that transplant programs be included in the emergency preparedness 
planning and the emergency preparedness program for the hospital in 
which it is located. We note that a transplant center is not 
individually responsible for the emergency preparedness requirements 
set forth in Sec.  482.15, except as detailed. Section 482.78(a) will 
require transplant centers to have policies and procedures that address 
emergency preparedness. Section 482.78(b) will require transplant 
centers to develop and maintain mutually-agreed upon protocols that 
address the duties and responsibilities of the transplant center, the 
hospital in which the transplant center is located, and the OPO during 
an emergency.
    All of the Medicare-approved transplant centers are located within 
hospitals and, as part of the hospital, should be included in the 
hospital's emergency preparedness plans. We expect that since 
transplants are part of the hospital, they are usually involved in the 
hospital's programs as part of their normal business practices. Thus, 
compliance with these requirements will constitute a usual and 
customary business practice and will not be subject to the PRA in 
accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2). We refer readers to the discussion in section H above 
regarding the burden estimate for hospitals.

J. ICRs Regarding Emergency Preparedness (Sec.  483.73)

1. Discussion of Omnibus Budget Reconciliation Act of 1987 Waiver
    Section 483.73 sets forth the emergency preparedness requirements 
for long term care (LTC) facilities. We would usually be required to 
estimate the information collection requirements (ICRs) for these 
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 PRA requirements for the regulations that implement the 
OBRA '87 requirements. Section 1819(d) of the Act, 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) of the Act, as implemented by OBRA '87.
    All of the requirements in this rule relate to disaster 
preparedness. We believe this waiver applies to those revisions we have 
made to existing requirements in part 483, subpart B. Thus, the ICRs 
for the requirements in Sec.  483.73 are not subject to the PRA. 
However, the waiver does not apply to the requirements of Executive 
Orders 12866 and 13563 under the Regulatory Impact Analysis (RIA) 
section. Therefore, to provide readers with sufficient context 
regarding the RIA discussion of the estimated costs to LTC facilities 
associated with this final rule, we have provided a discussion of the 
ICRs for LTC facilities in this COI section. We note that the estimates 
discussed in this section are not included in Table 128 ``Total Burden 
Hour Estimates for All Providers and Suppliers to Comply with the ICRs 
Contained in the Final Rule: Emergency Preparedness'', per the wavier 
discussed previously. Emergency preparedness plan that must be reviewed 
and updated at least annually. The plan will have to meet the 
requirements set out at Sec.  483.73(a)(1) through (4).
    Section 483.73(a)(1) requires LTC facilities to develop documented, 
facility-based and community-based-risk assessments utilizing an all-
hazards approach. We expect that all LTC facilities will need to 
identify the medical and non-medical emergency events they could 
experience in their facilities themselves and the communities in which 
they are located. We expect that in performing a risk assessment, a LTC 
facility will need to consider its physical location, the geographic 
area in which it is located, and its resident population.
    The burden associated with this requirement will be the time and 
effort necessary to perform a thorough risk assessment that complies 
with the requirements of this final rule. Existing requirements for LTC 
facilities already mandate that LTC facilities have ``detailed written 
plans and procedures to meet all potential emergencies and disasters, 
such as fire, severe weather, and missing residents'' (see existing 
Sec.  483.75(m)(1)). We expect that all LTC facilities already have 
performed some type of risk assessment during the process of developing 
their emergency and/or disaster plans and procedures. However, these 
risk assessments may not be as thorough as we require in this final 
rule, nor address all of the elements required by Sec.  483.73(a)(1). 
With the exception of severe weather, the existing requirements at 
Sec.  483.75(m)(1) discussed previously address emergencies and 
disasters that primarily arise within, or closely surrounding, a LTC 
facility. In addition,

[[Page 63962]]

the existing regulations do not specifically require LTC facilities to 
plan for man-made disasters. Therefore, we expect that under this final 
rule, all LTC facilities will need to conduct a review of their current 
risk assessments and then perform the necessary tasks to ensure that 
their risk assessments comply with the requirements.
    We have not identified any specific process or format for LTC 
facilities to use in conducting their risk assessments because we 
believe that they 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, healthcare institutions 
should include representatives from, or obtain input from, all of their 
major departments. Based on our experience with LTC facilities, we 
expect that reviewing, revising, and updating a facility's existing 
risk assessment will require the involvement of the LTC facility's 
administrator, director of nursing, and the facilities director. We 
expect that these individuals will attend an initial meeting, review 
relevant sections of the previous assessment, if any, develop comments 
and recommendations, attend a follow-up meeting, perform a final review 
along with the administrator, and approve the new risk assessment.
    In addition, we expect that the administrator will likely 
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 a new risk assessment, and 
ensure that the necessary parties approve the new risk assessment. 
Therefore, we expect that the administrator will spend more time than 
the other participants working on the risk assessment.
    We estimate that complying with this requirement will require 8 
burden hours at a cost of $692. There are 15,699 LTC facilities in the 
United States. Therefore, it will require an estimated 125,592 burden 
hours (8 burden hours for each LTC facility x 15,699 LTC facilities) 
for all LTC facilities to comply with this requirement at a cost of 
$10,863,708 ($692 estimated cost for each LTC facility x 15,699 LTC 
facilities).

                  Table 50--Total Cost Estimate for a LTC Facility To Develop a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................          $85.00               4         $340.00
Director of Nursing.............................................           85.00               2          170.00
Facilities Director.............................................           91.00               2          182.00
                                                                 -----------------------------------------------
    Totals......................................................  ..............               8          692.00
----------------------------------------------------------------------------------------------------------------

    After conducting the risk assessment, each LTC facility will then 
have to develop and maintain an emergency preparedness plan that 
addresses the requirements in Sec.  483.73(a)(1)-(4) and review and 
update this plan at least annually. Existing requirements for LTC 
facilities require them to have ``detailed written plans and procedures 
to meet all potential emergencies and disasters'' (see existing Sec.  
483.75(m)(1)). We expect all LTC facilities already have some type of 
emergency preparedness and/or disaster plan. However, as discussed 
previously, we expect these plans and procedures will primarily cover 
disasters and emergencies that will affect the facilities themselves 
and, with the exception of severe weather, not necessarily the 
communities in which they are located. We also expect that all LTC 
facilities will need to review their current plans, compare them to 
their revised risk assessments, and update, revise, and, if necessary, 
develop new sections for their plans to ensure their emergency plans 
address the risks identified in their risk assessments and the specific 
elements we are issuing in this final rule.
    The burden associated with this requirement will be the resources 
needed to review, revise, and, if needed, develop new sections for the 
LTC facility's existing emergency plan. Based upon our experience with 
LTC facilities, we expect that the same individuals who were involved 
in the risk assessment will be involved in these activities. We also 
expect these tasks will require more time to complete than the risk 
assessment.
    We expect that the administrator, director of nursing, and the 
facilities director will have to attend an initial meeting, review the 
facility's current emergency preparedness plan, develop comments and 
recommendations, attend a follow-up meeting, perform a final review, 
and approve the new emergency preparedness plan. We expect that the 
administrator will develop the emergency preparedness plan and ensure 
that the necessary parties approved it. We also expect that the 
administrator will spend more time than the other participants 
reviewing and working on the emergency preparedness plan.
    We estimate that complying with this requirement will require 12 
burden hours at a cost of $1,038 for each LTC facility. There are 
15,699 LTC facilities. Therefore, it will require an estimated 188,388 
burden hours (12 burden hours for each LTC facility x 15,699 LTC 
facilities) to complete the plan at a cost of $ ($1,038 estimated cost 
for each LTC facility x 15,699 LTC facilities).

                  Table 51--Total Cost Estimate for a LTC Facility To Develop an Emergency Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................          $85.00               6         $510.00
Director of Nursing.............................................           85.00               3          255.00
Facilities Director.............................................           91.00               3          273.00
                                                                 -----------------------------------------------
    Totals......................................................  ..............              12        1,038.00
----------------------------------------------------------------------------------------------------------------


[[Page 63963]]

    We require LTC facilities to review and update their emergency 
preparedness plans at least annually. The current emergency 
preparedness requirements for LTC facilities mandate that they 
``periodically review the procedures with their existing staff'' (Sec.  
483.75(m)(2)). We also expect that all LTC facilities will review and 
update their emergency preparedness plans annually. Thus, compliance 
with this requirement will constitute a usual and customary business 
practice for LTC facilities and will not be subject to the PRA in 
accordance with 5 CFR 1320.3(b)(2).
    Section 483.73(b) requires each LTC facility to develop and 
maintain emergency preparedness policies and procedures based on their 
emergency preparedness plan, risk assessment, and communication plan as 
set forth at Sec.  483.73(a), (a)(1), and (c), respectively. LTC 
facilities are also required to review and update these policies and 
procedures at least annually. These policies and procedures will have 
to address, at a minimum, the requirements set forth at Sec.  
483.73(b)(1) through (8).
    We expect that all LTC facilities have some emergency preparedness 
policies and procedures in place because existing regulations require 
them to have written disaster and emergency preparedness plans and 
procedures that address all potential disasters and emergencies (see 
exiting Sec.  483.75(m)(1)). However, under this final rule, all LTC 
facilities will need to review their policies and procedures, assess 
whether their policies and procedures incorporate all the elements of 
their emergency preparedness plan, and if necessary, take the 
appropriate steps to ensure that their policies and procedures 
encompass the requirements in this final rule.
    The burden associated with these requirements will be the time and 
effort necessary to review, revise, and, if necessary, develop new 
emergency policies and procedures. We expect that the administrator, 
the director of nursing, and the facilities director will be involved 
with reviewing, revising, and, if needed, developing any new policies 
and procedures. The administrator will brief any other staff and create 
assignments for purposes of making necessary revisions or drafting new 
policies and procedures and disseminate them to the appropriate 
parties. We estimate that complying with this requirement will require 
10 burden hours at a cost of $868. Therefore, for all LTC facilities to 
comply with this requirement will require an estimated 156,990 burden 
hours (10 burden hours for each LTC facility x 15,699 LTC facilities) 
at a cost of $13,626,732 ($868 estimated cost for each LTC facility x 
15,699 LTC facilities).

               Table 52--Total Cost Estimate for a LTC Facility To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................          $85.00               4         $340.00
Director of Nursing.............................................           85.00               3          255.00
Facilities Director.............................................           91.00               3          273.00
                                                                 -----------------------------------------------
    Totals......................................................  ..............              10          868.00
----------------------------------------------------------------------------------------------------------------

    LTC facilities will be required to review and update their 
emergency preparedness policies and procedures at least annually. We 
believe that LTC facilities already review their policies and 
procedures periodically. Hence, these activities will constitute a 
usual and customary business practice for LTC facilities and will not 
be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Section 483.73(c) will require each LTC facility to develop and 
maintain an emergency preparedness communication plan that complied 
with both federal and state law. The LTC facility will also have to 
review and update its plan at least annually. The communication plan 
will have to include the information listed in Sec.  483.73(c)(1) 
through (7).
    We expect that all LTC facilities will compare their current 
emergency preparedness communications plans, if they have one, to these 
requirements. The LTC facilities will then need to perform any tasks 
necessary to ensure that their communication plans were documented and 
in compliance with these requirements.
    We expect that all LTC facilities will have some type of emergency 
preparedness communication plan. Existing requirements for LTC 
facilities already require them to have written disaster plans and 
procedures (see existing Sec.  483.75(m)(1)). Since the ability to 
communicate with staff, residents' families, and external sources of 
assistance during an emergency is critical for all healthcare 
organizations, we believe that communication will be an integral part 
of any LTC facility's disaster plan. In addition, it is standard 
practice for healthcare organizations to maintain contact information 
for their staff and for outside sources of assistance; alternate means 
of communications in case there is a disruption in phone service to the 
facility; and a method for sharing information and medical 
documentation with other healthcare providers to ensure continuity of 
care for their residents. Thus, we expect that all LTC facilities 
already comply with the requirements of Sec.  483.73(c)(1) through (3). 
However, we also expect that many LTC facilities may not have formal, 
written emergency preparedness communication plans or their plans may 
not be in compliance with the elements required in Sec.  483.73(c)(4) 
through (7). Therefore, we expect that under this final rule, all LTC 
facilities will need to review, update, and in some cases, develop new 
sections for their emergency communication plans, to ensure those plans 
include all of these elements.
    The burden associated with complying with this requirement will be 
the resources needed to review, update, and, if necessary, develop new 
sections for the LTC facility's existing communication plans. Based 
upon our experience with LTC facilities, we expect that satisfying the 
requirements of this section will require the involvement of the LTC 
facility's administrator and the director of nursing. We estimate that 
complying with this requirement will require 6 burden hours for each 
facility at a cost of $510. For all LTC facilities to comply with this 
requirement will require an estimated 94,194 burden hours (6 burden 
hours for each LTC facility x 15,699 LTC facilities) at a cost of 
$8,006,490 ($510 estimated cost for each LTC facility x 15,699 LTC 
facilities).

[[Page 63964]]



               Table 53--Total Cost Estimate for a LTC Facility To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................          $85.00               3         $255.00
Director of Nursing.............................................           85.00               3          255.00
                                                                 -----------------------------------------------
    Totals......................................................  ..............               6          510.00
----------------------------------------------------------------------------------------------------------------

    LTC facilities will also have to review and update its emergency 
preparedness communication plan at least annually. We believe that LTC 
facilities already review and update their plans and procedures 
periodically. Thus, the requirement for an annual review of the 
emergency preparedness communications plan constitutes a usual and 
customary business practice for LTC facilities and will not be subject 
to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Section 483.73(d) will require LTC facilities to develop and 
maintain emergency preparedness training and testing programs. These 
training and testing programs will have to be reviewed and updated at 
least annually. LTC facilities will have to comply with the 
requirements in Sec.  483.73(d)(1) and (2).
    With respect to Sec.  483.73(d)(1), each LTC facility will 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 that training. 
Thereafter, each LTC facility will have to provide the training at 
least annually.
    Existing requirements for LTC facilities require facilities to 
``train all employees in emergency procedures when they begin to work 
in the facility'' and ``periodically review the procedures with 
existing staff'' (See existing Sec.  483.75(m)(2)). Therefore, we 
expect that LTC facilities already provide some type of emergency 
preparedness training program for new employees, as well as ongoing 
training for all staff. However, to ensure compliance with the 
requirements of this final rule, all LTC facilities will need to review 
their current training programs to ensure that they met all of the 
requirements in this final rule.
    Each LTC facility will need to compare its current emergency 
preparedness training program's contents to its updated emergency 
preparedness plan, risk assessment, policies and procedures, and 
communication plan and then review, revise, and, if necessary, develop 
new sections for its training program to ensure that it complied with 
these requirements.
    The burden associated with complying with this requirement will be 
the time and effort necessary for a LTC facility to compare its current 
emergency preparedness training program's contents to its updated 
emergency preparedness plan, risk assessment, policies and procedures, 
and communication plan and then review, revise, and, if necessary, 
develop new sections for its training program to ensure that it 
complies with the requirements of this final rule. We believe that 
these activities will require the involvement of an administrator and 
the director of nursing. We expect that the director of nursing will 
likely spend more time than the administrator working on the training 
program. We estimate that complying with this requirement will require 
10 burden hours for each LTC facility at an estimated cost of $850. For 
all 15,699 LTC facilities to comply with this requirement, it will 
require an estimated 156,990 burden hours (10 burden hours for each LTC 
facility x 15,699 LTC facilities) at a cost of $13,344,150 ($850 
estimated cost for each LTC facility x 15,699 LTC facilities).

                      Table 54--Total Cost Estimate for a LTC Facility To Conduct Training
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................          $85.00               2         $170.00
Director of Nursing.............................................           85.00               8          680.00
                                                                 -----------------------------------------------
    Totals......................................................  ..............              10             850
----------------------------------------------------------------------------------------------------------------

    Each LTC facility will be required to review and update its 
emergency preparedness training program at least annually. We believe 
that LTC facilities already review and update their training programs 
periodically. Thus, compliance with this requirement will constitute a 
usual and customary business practices for LTC facilities and will not 
be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
    Section 483.73(d)(2) will require LTC facilities to participate in 
a full-scale exercise at least annually. LTC facilities are also 
required to participate in one additional testing exercise of their 
choice at least annually. LTC facilities will also have to analyze 
their responses to, and maintain documentation of all exercises and 
emergency events. If a LTC facility experienced an actual emergency 
which required activation of its emergency plan, the LTC facility will 
be exempt from the requirement for a community or individual, facility-
based disaster exercise for 1 year following the onset of the actual 
event (Sec.  483.73(d)(2)(ii)).
    To comply with these testing requirements, a LTC facility will need 
to develop a scenario for each exercise. A LTC facility will also need 
to develop the necessary documentation to record and analyze their 
response to all testing exercises and emergency events.
    Existing requirements for LTC facilities already mandate that these 
facilities ``periodically review the procedures with existing staff, 
and carry out unannounced staff drills'' (Sec.  483.75(m)(2)). We 
expect that all LTC facilities are already developing and conducting 
drills or exercises for their disaster plans. It is also standard 
practice in the healthcare industry to document what happens during a 
drill, exercise, or emergency event and analyze the facility's response 
to those events. However, the LTC facility requirements do not specify 
how often

[[Page 63965]]

the facility must conduct a drill or the type of drills. For purposes 
of determine the burden associated with the testing requirements in 
this final rule, we will assume that all LTC facilities will need to 
develop scenarios for their testing exercises and the documentation 
necessary to record the events during the testing exercises.
    To comply with these requirements we expect it will mainly require 
the involvement of the director of nursing. We expect that the director 
of nursing will develop the required documentation, as well as the 
scenarios for the testing exercises. We expect that the administrator 
will provide some assistance and approve the scenarios. We estimate 
that these tasks will require 5 burden hours at a cost of $425. Based 
on this estimate, it will require 78,495 burden hours (5 burden hours 
for each LTC facility x 15,699 LTC facilities) for all 15,699 LTC 
facilities to comply with these requirements at a cost of $6,672,075 
($425 estimated cost for each LTC facility x 15,699 LTC facilities).

                 Table 55--Total Cost Estimate for a LTC Facility To Conduct Training Exercises
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................          $85.00               1          $85.00
Director of Nursing.............................................           85.00               4          340.00
                                                                 -----------------------------------------------
    Totals......................................................  ..............               5             425
----------------------------------------------------------------------------------------------------------------


    Table 56--Burden Hours and Cost Estimates for all 15,699 LTC Facilities To Comply With the ICRS Contained in Sec.   483.73 Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                               Number of    Number of    Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      respondents   responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   483.73(a)(1)................  0938-New..............        15,699       15,699            8      125,592          * *    10,863,708   10,863,708
Sec.   483.73(a)(1)-(4)............  0938-New..............        15,699       15,699           12      188,388          * *    16,295,562   16,295,562
Sec.   483.73(b)...................  0938-New..............        15,699       15,699           10      156,990          * *    13,626,732   13,626,732
Sec.   483.73(c)...................  0938-New..............        15,699       15,699            6       94,194          * *     8,006,490    8,006,490
Sec.   483.73(d)(1)................  0938-New..............        15,699       15,699           10      156,990          * *    13,344,150   13,344,150
Sec.   483.73(d)(2)................  0938-New..............        15,699       15,699            5       78,495          * *     6,672,075    6,672,075
                                    --------------------------------------------------------------------------------------------------------------------
    Totals.........................  ......................        15,699       94,194  ...........      800,649  ............  ...........   68,808,717
--------------------------------------------------------------------------------------------------------------------------------------------------------
* *The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 56.

    Comment: A commenter appreciated that OBRA '87 provided for a 
waiver of PRA requirements. However, the commenter requested that we 
publish the anticipated burden that these requirements would impose on 
LTC facilities for their information.
    Response: We appreciate the commenter's request and have provided a 
discussion of the anticipated ICRs in this final rule.

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

    Section 483.475(a) will require intermediate care facilities for 
individuals with intellectual disabilities (ICF/IID) to develop and 
maintain an emergency preparedness plan that will have to be reviewed 
and updated at least annually. We proposed that the plan will 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.
    Section 483.475(a)(1) will 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 risk 
assessment, we expect that an ICF/IID will need to consider its 
physical location, the geographical area in which it is located, and 
its client population.
    The burden associated with this requirement will 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 will 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 Sec.  483.475(a). Therefore, 
all ICFs/IID will 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 
will 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 will 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 will require the 
involvement of the ICF/IID administrator and a professional staff 
person, such as a registered nurse. We expect that both individuals 
will attend

[[Page 63966]]

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 will 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 will spend more time reviewing and working on the 
risk assessment. Thus, we estimate that complying with this requirement 
will require 8 burden hours to complete at a cost of $657. There are 
currently 6,237 ICFs/IID. Therefore, it will require an estimated 
49,896 burden hours (8 burden hours for each ICF/IID x 6,237 ICFs/IID) 
for all ICFs/IID to comply with this requirement at a cost of 
$4,097,709 ($657 estimated cost for each ICF/IID x 6,237 ICFs/IID).

                    Table 57--Total Cost Estimate for an ICF/IID To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $93               5            $465
Registered Nurse................................................              64               3             192
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8             657
----------------------------------------------------------------------------------------------------------------

    Under this final rule, ICFs/IID will 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 will 
have to review its current plans and compare them to its risk 
assessments. Each ICF/IID will then need to update, revise, and, in 
some cases, develop new sections to comply with our requirements.
    The burden associated with this requirement will 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 will be 
involved in developing the facility's new emergency preparedness plan. 
We also expect that developing the plan will be more labor intensive 
and will require more time to complete than the risk assessment. We 
estimate that it will require 9 burden hours at a cost of $750 for each 
ICF/IID to develop an emergency plan that complied with the 
requirements in this section. Based on this estimate, it will require 
56,133 burden hours (9 burden hours for each ICF/IID x 6,237 ICFs/IID) 
to complete the plan at a cost of $4,677,750 ($750 estimated cost for 
each ICF/IID x 6,237 ICFs/IID).

             Table 58--Total Cost Estimate for an ICF/IID To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $93               6            $558
Registered Nurse................................................              64               3             192
                                                                 -----------------------------------------------
    Total.......................................................  ..............               9             750
----------------------------------------------------------------------------------------------------------------

    The ICF/IID also will 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, 
we believe compliance with this requirement will constitute a usual and 
customary business practice and will not be subject to the PRA in 
accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    Section 483.475(b) will require each ICF/IID to develop and 
implement emergency preparedness policies and procedures, based on its 
emergency plan set forth in paragraph (a), the risk assessment at 
paragraph (a)(1), and the communication plan at paragraph (c). We will 
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 will 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 will 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 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 will 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 will need

[[Page 63967]]

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 will be the 
resources needed to ensure that the ICF/IID policies and procedures 
complied with the requirements of this section. We expect that these 
tasks will involve the ICF/IID administrator and a registered nurse. We 
estimate that for each ICF/IID to comply will require 9 burden hours at 
a cost of $750. Based on this estimate, for all 6,237 ICFs/IID to 
comply with this requirement will require 56,133 burden hours (9 burden 
hours for each ICF/IID x 6,237 ICFs/IID) at a cost of $4,677,750 ($750 
estimated cost for each ICF/IID x 6,237 ICFs/IID).

                 Table 59--Total Cost Estimate for an ICF/IID To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $93               6            $558
Registered Nurse................................................              64               3             192
                                                                 -----------------------------------------------
    Total.......................................................  ..............               9             750
----------------------------------------------------------------------------------------------------------------

    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, we believe compliance with this requirement will constitute a 
usual and customary business practice and will not be subject to the 
PRA in accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    Section 483.475(c) will require each ICF/IID to develop and 
maintain an emergency preparedness communication plan that complied 
with both federal and state law. The ICF/IID will 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. The ICFs/IID also will need to perform 
any tasks necessary to ensure that they document their communication 
plans and that those plans comply with the requirements of this 
section.
    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 will include communication. Furthermore, it 
is standard practice for healthcare 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 
healthcare 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 will be 
the resources required to ensure that the ICF/IID emergency 
communication plan complied with the requirements. Based upon our 
experience with ICFs/IID, we anticipate that meeting the requirements 
in this section will primarily require the involvement of the ICF/IID 
administrator and a registered nurse. We estimate that for each ICF/IID 
to comply with the requirement will require 6 burden hours at a cost of 
$500. Therefore, for all 6,237 ICFs/IID to comply with this requirement 
will require an estimated 37,442 burden hours (6 burden hours for each 
ICF/IID x 6,237 ICFs/IID) at a cost of $3,118,500 ($500 estimated cost 
for each ICF/IID x 6,237 ICFs/IID).

                  Table 60--Total Cost Estimate for an ICF/IID To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $93               4            $372
Registered Nurse................................................              64               2             128
                                                                 -----------------------------------------------
    Total.......................................................  ..............               6             500
----------------------------------------------------------------------------------------------------------------

    The ICFs/IID will 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, we believe compliance with this requirement will 
constitute a usual and customary business practice and will not be 
subject to the PRA in accordance with the implementing regulations of 
the PRA at 5 CFR 1320.3(b)(2).
    Section 483.475(d) will require ICFs/IID to develop and maintain 
emergency preparedness training and testing programs that will have to 
be reviewed and updated at least annually. Each ICF/IID will 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 
will 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 will have to provide emergency preparedness 
training at least annually.
    The ICFs/IID will 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 
requirements. The current ICFs/IID

[[Page 63968]]

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 final rule, each ICF/IID will 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 will need to revise and, if 
necessary, develop new sections for their training program to ensure it 
complied with the requirements.
    The burden will be the time and effort necessary to comply with the 
requirements. We expect that a registered nurse will 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 will need to be performed to 
comply with the requirements of this section; accomplishing those 
tasks, and developing an updated training program. We expect the 
administrator will work with the registered nurse to update the 
training program. We estimate that it will require 7 burden hours for 
each ICF/IID to develop an emergency training program at a cost of 
$506. Therefore, it will require an estimated 43,659 burden hours (7 
burden hours for each ICF/IID x 6,237 ICFs/IID) to comply with this 
requirement at a cost of $3,155,922 ($506 estimated cost for each ICF/
IID x 6,237 ICFs/IID).

                   Table 61--Total Cost Estimate for an ICF/IID To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $93               2            $186
Registered Nurse................................................              64               5             320
                                                                 -----------------------------------------------
    Total.......................................................  ..............               7             506
----------------------------------------------------------------------------------------------------------------

    The ICFs/IID will 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, we believe compliance with this requirement will 
constitute a usual and customary business practice and will not be 
subject to the PRA in accordance with the implementing regulations of 
the PRA at 5 CFR 1320.3(b)(2).
    Section 483.475(d)(2) will require ICFs/IID to participate in a 
full-scale exercise and one additional exercise of their choice at 
least annually. The ICFs/IID will also be required to analyze their 
responses to and maintain documentation of all testing 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 will be exempt 
from engaging in a full-scale exercise for 1 year following the onset 
of the actual event. To comply with this requirement, an ICF/IID will 
need to develop scenarios for each testing exercise. An ICF/IID also 
will 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 proposed requiring or that scenarios are used for each 
drill or tabletop exercise. For the purpose of determining a burden for 
these requirements, all ICFs/IID will have to develop scenarios and all 
ICFs/IID will have to develop the necessary documentation.
    The burden associated with these requirements will be the resources 
the ICF/IID will need to comply with the requirements. We expect that 
complying with these requirements will likely require the involvement 
of a registered nurse. We expect that the registered nurse will develop 
the required documentation. We also expect that the registered nurse 
will develop the scenarios for the each testing exercise. We estimate 
that these tasks will require 4 burden hours at a cost of $256. Based 
on this estimate, for all 6,237 ICFs/IID to comply, it will require 
24,948 burden hours (4 burden hours for each ICF/IID x 6,237 ICFs/IID) 
at a cost of $1,596,672 ($256 estimated cost for each ICF/IID x 6,237 
ICFs/IID).

                         Table 62--Total Cost Estimate for an ICF/IID To Conduct Testing
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Registered Nurse................................................             $64               4            $256
                                                                 -----------------------------------------------
    Total.......................................................  ..............               4             256
----------------------------------------------------------------------------------------------------------------


 Table 63--Burden Hours and Cost Estimates for all 6,237 ICFs/IID To Comply With the ICRs Contained in Sec.   485.475 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                                                         Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      Respondents   Responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   483.475(a)(1)...............                                 6,237        6,237            8       49,896          * *     4,097,709    4,097,709

[[Page 63969]]

 
Sec.   483.475(a)(1)-(4)...........                                 6,237        6,237            9       56,133          * *     4,677,750    4,677,750
Sec.   483.475(b)..................                                 6,237        6,237            9       56,133          * *     4,677,750    4,677,750
Sec.   483.475(c)..................                                 6,237        6,237            6       37,422          * *     3,118,500    3,118,500
Sec.   483.475(d)(1)...............                                 6,237        6,237            7       43,659          * *     3,155,922    3,155,922
Sec.   483.475(d)(2)...............                                 6,237        6,237            4       24,948          * *     1,596,672    1,596,672
                                    --------------------------------------------------------------------------------------------------------------------
    Totals.........................                                 6,237       37,422  ...........      268,191  ............  ...........   21,324,303
--------------------------------------------------------------------------------------------------------------------------------------------------------
* *The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 63.

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

    Section 484.22(a) will require home health agencies (HHAs) to 
develop and maintain emergency preparedness plans. Each HHA also will 
be required to review and update the plan at least annually. 
Specifically, we proposed 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 will 
experience under this final 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 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 final rule.
    As of June 2016, there are currently 12,335 HHAs. There are 4,330 
TJC-accredited HHAs. A review of TJC deeming standards indicates that 
the 4,330 TJC-accredited HHAs already perform certain tasks or 
activities that will partially or completely satisfy our requirements. 
Therefore, since TJC accreditation is a significant factor in 
determining the burden, we will analyze the burden for the 4,330 TJC-
accredited HHAs separately from the 8,005 non TJC-accredited HHAs 
(12,335 HHAs-4,330 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) will 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 will 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 will expect HHAs to consider the extent of their service 
area, including the location of any branch offices. An HHA with an 
existing risk assessment will need to review, revise and update it to 
comply with our requirements.
    For TJC accreditation standards, we used TJC's CAMHC Refreshed 
Core, January 2008 pages from the Comprehensive Accreditation Manual 
for Home Care 2008 (CAMHC). In the chapter entitled, ``Environmental 
Safety and Equipment Management'' (EC), TJC accreditation standards 
require HHAs to conduct proactive risk assessments to ``evaluate the 
potential adverse impact of the external environment and the services 
provided on the security of patients, staff, and other people coming to 
the organization's facilities'' (CAMHC, Standard EC.2.10, EP 3, p. EC-
7). These proactive risk assessments should evaluate the risk to the 
entire organization, and the HHA should conduct one of these 
assessments whenever it identifies any new external risk factors or 
begins a new service (CAMHC, Standard EC.2.10, p. EC-7). Moreover, 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 will satisfy our 
requirements. Any tasks needed to comply with our requirements will not 
result in any additional burden. Thus, for the 4,330 TJC-accredited 
HHAs, the risk assessment requirement will constitute a usual and 
customary business practice and will not be subject to the PRA in 
accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    It is standard practice for healthcare 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 8,005 non TJC-accredited HHAs have conducted some type of risk 
assessment. However, those risk assessments are unlikely to satisfy all 
of our requirements. Therefore, we will analyze the burden for the 
8,005 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 will include representatives from or input 
from all of their major departments. Based on our

[[Page 63970]]

experience working with HHAs, we expect that conducting the risk 
assessment will require the involvement of an HHA administrator, the 
director of nursing, director of rehabilitation, and the office 
manager. We expect that these individuals will 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 
will 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 will spend more time developing the 
facility's new risk assessment than the other individuals. We estimate 
that the risk assessment will require 11 burden hours for each non TJC-
accredited HHA to complete at a cost of $959. There are currently about 
8,005 non TJC-accredited HHAs. We estimate that for all non TJC-
accredited HHAs to comply with this requirement will require 88,055 
burden hours (11 burden hours for each non TJC-accredited HHA x 8,005 
non TJC-accredited HHAs) at a cost of $7,676,795 ($959 estimated cost 
for each non TJC-accredited HHA x 8,005 non TJC-accredited HHAs).

             Table 64--Total Cost Estimate for a Non TJC-Accredited HHA To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               2            $194
Director of Nursing.............................................              97               5             485
Director of Rehabilitation......................................              88               2             176
Office Manager..................................................              52               2             104
                                                                 -----------------------------------------------
    Total.......................................................  ..............              11          959.00
----------------------------------------------------------------------------------------------------------------

    After conducting a risk assessment, HHAs will 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 proposed at Sec.  484.22(a). 
Thus, we expect that TJC-accredited HHAs have an emergency preparedness 
plan that will satisfy most of our 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 1,815 TJC-
accredited HHAs will 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 8,005 non TJC-accredited HHAs because we expect the 
burden for TJC-accredited HHAs to be substantially less.
    We expect that the 8,005 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 requirements. Thus, all non TJC-
accredited HHAs will need to review their current plans and compare 
them to their risk assessments. They also will 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 will be involved 
in developing the emergency preparedness plan. We estimate that 
complying with this requirement will require 10 burden hours for each 
TJC-accredited HHA at a cost of $862. Therefore, for all 4,330 TJC-
accredited HHAs to comply will require an estimated 43,300 burden hours 
(10 burden hours for each TJC-accredited HHA x 4,330 TJC-accredited 
HHAs) at a cost of $3,732,460 ($862 estimated cost for each HHA x 4,330 
TJC-accredited HHAs).

        Table 65--Total Cost Estimate for a TJC-Accredited HHA To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               2            $194
Director of Nursing.............................................              97               4             388
Director of Rehabilitation......................................              88               2             176
Office Manager..................................................              52               2             104
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10             862
----------------------------------------------------------------------------------------------------------------

    We estimate that complying with this requirement will require 15 
burden hours for each of the 8,005 non TJC-accredited HHAs at a cost of 
$1,293. Therefore, for all 8,005 non TJC-accredited HHAs to comply will 
require an estimated 120,075 burden hours (15 burden hours for each non 
TJC-accredited HHA x 8,005 non TJC-accredited HHAs) at a cost of 
$10,350,465 ($1,293 estimated cost for each non TJC-accredited HHA x 
8,005 non TJC-accredited HHAs).

[[Page 63971]]



      Table 66--Total Cost Estimate for a Non-TJC Accredited HHA To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               3            $291
Director of Nursing.............................................              97               6             582
Director of Rehabilitation......................................              88               3             264
Office Manager..................................................              52               3             156
                                                                 -----------------------------------------------
    Total.......................................................  ..............              15           1,293
----------------------------------------------------------------------------------------------------------------

    Based on these estimates, for all 12,335 HHAs to develop an 
emergency preparedness plan that complies with our requirements will 
require 163,375 burden hours at a cost of $14,082,925. We will 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, we believe 
compliance with this requirement will constitute a usual and customary 
business practice for HHAs and will not be subject to the PRA in 
accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    Section 484.22(b) will 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 will also have to 
review and update its policies and procedures at least annually. We 
will 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 will review their emergency preparedness 
policies and procedures and compare them to their risk assessments, 
emergency preparedness plans, and emergency communication plans. HHAs 
will need to revise or, in some cases, develop new policies and 
procedures to ensure they complied with all of the 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 4,330 TJC-accredited HHAs already have emergency 
preparedness policies and procedures that address some of the 
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 requirements for emergency policies 
and procedures. Thus, we will include the 4,330 TJC-accredited HHAs 
with the 8,005 non TJC-accredited HHAs in our analysis of the burden 
for Sec.  484.22(b).
    Under Sec.  484.22(b)(1), the HHA's individual plans for patients 
during a natural or man-made disaster will be included as part of the 
comprehensive patient assessment, which will be conducted according to 
the provisions at Sec.  484.55. We expect that HHAs already collect 
data during the comprehensive patient assessment that they will need to 
develop for each patient's emergency plan. At Sec.  484.22(b)(2), we 
proposed 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 Sec.  484.22(b)(1) and 
(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) will constitute usual 
and customary business practices for HHA and will not be subject to the 
PRA in accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    We expect that all 12,520 HHAs have some emergency preparedness 
policies and procedures. However, we also expect that all HHAs will 
need to review their policies and procedures and revise and, if 
necessary, develop new policies and procedures that complied with our 
requirements set out at Sec.  484.22(3) through (6). We expect that a 
professional staff person, most likely the director of nursing, will 
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 will 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 will require 18 burden hours for each 
HHA at a cost of $1,584. Thus, for all 12,335 HHAs to comply with all 
of our requirements will require an estimated 222,030 burden hours (18 
burden hours for each HHA x 12,335 HHAs) at a cost of $19,538,640 
($1,584 estimated cost for each HHA x 12,335 HHAs).

                   Table 67--Total Cost Estimate for a HHA To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               4            $388
Director of Nursing.............................................              97               8             776

[[Page 63972]]

 
Director of Rehabilitation......................................              88               3             264
Office Manager..................................................              52               3             156
                                                                 -----------------------------------------------
    Total.......................................................  ..............              18           1,584
----------------------------------------------------------------------------------------------------------------

    We are also proposing that HHAs review and update their emergency 
preparedness policies and procedures at least annually. The current 
CoPs require HHAs to establish and annually review the agency's 
policies governing scope of services offered, admission and discharge 
policies, medical supervision and plans of care, emergency clinical 
records and program evaluation. (42 CFR 484.16). Thus, we believe that 
complying with this requirement will constitute a usual and customary 
business practice for HHAs and will not be subject to the PRA in 
accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    In Sec.  484.22(c), each HHA will be required to develop and 
maintain an emergency preparedness communication plan that complied 
with both federal and state law. We proposed that each HHA review and 
update its communication plan at least annually. We will require that 
the emergency communication plan include the information listed at 
Sec.  484.22(c)(1) through (6).
    It is standard practice for healthcare 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 healthcare 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 
requirements. Thus, we will include the 4,330 TJC-accredited HHAs with 
the 8,005 non TJC-accredited HHAs in assessing the burden for this 
requirement.
    We expect that all 12,335 HHAs maintain some contact information, 
an alternate means of communication, and a method for sharing 
information with other healthcare facilities. However, this will not 
ensure that all HHAs will be in compliance with our requirements for 
communication plans. Thus, we will analyze the burden for this 
requirement for all 12,335 HHAs.
    The burden associated with complying with this requirement will 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 requirements. Based on our 
experience with HHAs, we expect that these activities will require the 
involvement of the HHA's administrator, director of nursing, director 
of rehabilitation, and office manager. We estimate that complying with 
this requirement will require 10 burden hours for each HHA at a cost of 
$826. Thus, for all 12,335 HHAs to comply with these requirements will 
require an estimated 123,350 burden hours (10 burden hours for each HHA 
x 123,350 HHAs) at a cost of $10,188,710 ($826 estimated cost for each 
HHA x 123,350 HHAs).

                     Table 68--Total Cost Estimate for a HHA To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               1             $97
Director of Nursing.............................................              97               5             485
Director of Rehabilitation......................................           88.00               1              88
Office Manager..................................................           52.00               3             156
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................................................  ..............              10             826
----------------------------------------------------------------------------------------------------------------

    We proposed 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, we believe compliance with this requirement will constitute a 
usual and customary business practice for HHAs and will not be subject 
to the PRA in accordance with the implementing regulations of the PRA 
at 5 CFR 1320.3(b)(2). Section 484.22(d) will require each HHA to 
develop and maintain an emergency preparedness training and testing 
program. Each HHA will also have to review and update its training and 
testing program at least annually. Section 484.22(d)(1) states that 
each HHA will 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 will have to provide emergency 
preparedness training at least annually. Each HHA will also have to 
ensure that their staff could demonstrate knowledge of their emergency 
procedures.
    Based on our experience with HHAs, we expect that all 12,335 HHAs 
have some type of emergency preparedness training program because this 
a key component of emergency preparedness and as stated earlier, it is 
standard

[[Page 63973]]

practice for healthcare facilities to prepare for common internal and 
external medical and non-medical emergencies, based on their location, 
structure, and the services they provide. The 4,330 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 will ensure that their orientations and ongoing 
staff training will include the facility's emergency preparedness 
policies and procedures.
    However, we expect that under Sec.  484.22(d), all HHAs will 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 
will need to revise and, in some cases, develop new sections for their 
training programs to ensure that they complied with our requirements. 
In addition, HHAs will 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 requirements for all 12,335 HHAs.
    Based on our experience with HHAs, we expect that complying with 
this requirement will 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 will 
spend more time reviewing, revising or developing new sections for the 
training program than the other individuals. We estimate that it will 
require 16 burden hours for each HHA to develop an emergency 
preparedness training and testing program at a cost of $1,132. Thus, 
for all 12,335 HHAs to comply will require an estimated 197,360 burden 
hours (16 burden hours for each HHA x 12,335 HHAs) at a cost of 
$13,963,220 ($1,132 estimated cost for each HHA x 12,335 HHAs).

                      Table 69--Total Cost Estimate for a HHA To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               2            $194
Director of Nursing.............................................              97               2             194
Director of Rehabilitation......................................              88               2             176
Office Manager..................................................              52               2             104
Director of Training............................................              58               8             464
                                                                 -----------------------------------------------
    Total.......................................................  ..............              16           1,132
----------------------------------------------------------------------------------------------------------------

    We also proposed that HHAs should review and update their emergency 
preparedness training programs at least annually. The current CoPs 
require HHAs to establish and annually review the agency's policies 
governing scope of services offered, admission and discharge policies, 
medical supervision and plans of care, emergency care clinical records, 
and program evaluation. We believe that HHAs already review their 
training and testing programs periodically. Thus, we believe compliance 
with this requirement will constitute a usual and customary business 
practice for HHAs and will not be subject to the PRA in accordance with 
the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 484.22(d)(2) will require each HHA to conduct exercises to 
test its emergency plan. Each HHA will have to participate in a full-
scale exercise and one additional exercise at least annually. If an HHA 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, it will be exempt from engaging in a 
full-scale exercise for 1 year following the onset of the actual event. 
Each HHA will 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 
will have to comply with all of the requirements. The burden associated 
with complying with this requirement will be the time and effort 
necessary to develop the scenarios for the testing exercises 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 will not ensure that TJC-
accredited HHAs will be in compliance with our requirements. Therefore, 
we will include the 4,330 TJC-accredited HHAs with the 8,005 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 will develop the scenarios for the testing exercises 
and the accompanying documentation. We expect that the director of 
nursing will spend more time on these activities than will the other 
individuals. We estimate that it will require 7 burden hours for each 
HHA to comply with the requirements at an estimated cost of $586. Thus, 
for all 12,335 HHAs to comply with the requirements in this section 
will require an estimated 86,345 burden hours (7 burden hours for each 
HHA x 12,335 HHAs) at a cost of $7,228,310 ($586 estimated cost for 
each HHA x 12,335 HHAs).

[[Page 63974]]



                           Table 70--Total Cost Estimate for a HHA To Conduct Testing
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               1             $97
Director of Nursing.............................................              97               3             291
Director of Rehabilitation......................................              88               1              88
Office Manager..................................................              52               1              52
Director of Training............................................              58               1              58
                                                                 -----------------------------------------------
    Total.......................................................  ..............               7             586
----------------------------------------------------------------------------------------------------------------


   Table 71--Burden Hours and Cost Estimates for All 12,335 HHAs To Comply With the ICRs Contained in Sec.   484.22 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                               Number of    Number of    Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      respondents   responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   484.22(a)(1)................  0938-New..............         8,005        8,005           11       88,055           **     7,676,795    7,676,795
Sec.   484.22(a)(1)-(4) (TJC-        0938-New..............         4,330        4,330           10       43,300           **     3,732,460    3,732,460
 accredited).
Sec.   484.22(a)(1)-(4) (Non TJC-    0938-New..............         8,005        8,005           15      120,075           **    10,350,465   10,350,465
 accredited).
Sec.   484.22(b)...................  0938-New..............        12,335       12,335           18      222,030           **    19,538,640   19,538,640
Sec.   484.22(c)...................  0938-New..............        12,335       12,335           10      123,350           **    10,188,710   10,188,710
Sec.   484.22(d)(1)................  0938-New..............        12,335       12,335           16      197,360           **    13,963,220   13,963,220
Sec.   484.22(d)(2)................  0938-New..............        12,335       12,335            8       86,345           **     7,228,310    7,228,310
                                                            --------------------------------------------------------------------------------------------
    Total..........................  ......................        24,670       69,680  ...........      880,515  ............  ...........   72,678,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 71.

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

    Section 485.68(a) will 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 proposed that the plan meet the requirements listed at Sec.  
485.68(a)(1) through (5).
    Section 485.68(a)(1) will require a CORF to develop a documented, 
facility-based and community-based risk assessment utilizing an all-
hazards approach. The CORFs will 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 requirements. Therefore, we expect that 
all CORFs will need to review their existing risk assessments and 
perform the tasks necessary to ensure that those assessments meet our 
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 will obtain input from all of their major 
departments. Based on our experience with CORFs, we expect that 
conducting the risk assessment will 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 will 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 will 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 will require 8 
burden hours at a cost of $722. There are currently 205 CORFs. 
Therefore, it will require an estimated 1,640 burden hours (8 burden 
hours for each CORF x 205 CORFs) for all CORFs to comply at a cost of 
$148,010 ($722 estimated cost for each CORF x 205 CORFs).

                      Table 72--Total Cost Estimate for a CORF To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               5            $485
Physical Therapist..............................................              79               3             237
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8             722
----------------------------------------------------------------------------------------------------------------

    After conducting the risk assessment, each CORF will need to 
review, revise, and, if necessary, develop new sections for its 
emergency plan so that it complied with our requirements. The current 
CoPs for CORFs require them to

[[Page 63975]]

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 will need to review, revise, and develop new sections 
for their plans to ensure that their plans complied with all of our 
requirements.
    Based on our experience with CORFs, we expect that the 
administrator and physical therapist who were involved in developing 
the risk assessment will be involved in developing the emergency 
preparedness plan. However, we expect that it will require more time to 
complete the emergency plan than to complete the risk assessment. We 
estimate that complying with this requirement will require 11burden 
hours at a cost of $1,013 for each CORF. Therefore, it will require an 
estimated 2,255 burden hours (11 burden hours for each CORF x 205 
CORFs) for all CORFs to complete an emergency preparedness plan at a 
cost of $207,665 ($1,013 estimated cost for each CORF x 205 CORFs).

               Table 73--Total Cost Estimate for a CORF To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               8            $776
Physical Therapist..............................................              79               3             237
                                                                 -----------------------------------------------
    Total.......................................................  ..............              11           1,013
----------------------------------------------------------------------------------------------------------------

    The CORF also will 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 
will constitute a usual and customary business practice for CORFs and 
will not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 485.68(b) will 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 will also require CORFs to 
review and update these policies and procedures at least annually. We 
will 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 will 
need to review their policies and procedures and compare them to their 
risk assessments, emergency preparedness plans, and communication 
plans. Most CORFs will need to revise their existing policies and 
procedures or develop new policies and procedures to ensure they 
complied with all of our requirements.
    We expect that both the administrator and the therapist will 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 will coordinate the meetings, coordinate the 
comments, and ensure that they are approved.
    We estimate that it will take 9 burden hours for each CORF to 
comply with this requirement at a cost of $819. Therefore, it will take 
all 205 CORFs 1,845 burden hours (9 burden hours for each CORF x 205 
CORFs = 1,845 burden hours) to comply with this requirement at a cost 
of $167,895 ($819 estimated cost for each CORF x 205 CORFs).

                   Table 74--Total Cost Estimate for a CORF To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               6            $582
Physical Therapist..............................................              79               3             237
                                                                 -----------------------------------------------
    Total.......................................................  ..............               9             819
----------------------------------------------------------------------------------------------------------------

    Section 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 will constitute a usual and customary business practice for 
CORFs and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 485.68(c) will require CORFs to develop and maintain 
emergency preparedness communication plans that complied with both 
federal and state law and that will be reviewed and updated at least 
annually. We proposed 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 healthcare 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 
healthcare 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 will

[[Page 63976]]

need to review, update, and in some cases, develop new sections for 
their plans to ensure they complied with all of our requirements.
    Based on our experience with CORFs, we anticipate that satisfying 
the requirements in this section will 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 will 
take 8 burden hours for each CORF to comply with this requirement at a 
cost of $722. Therefore, it will take 1,640 burden hours (8 burden 
hours for each CORF x 205 CORFs) for all CORFs to comply at a cost of 
$148,010 ($722 estimated cost for each CORF x 205 CORFs).

                    Table 75--Total Cost Estimate for a CORF To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               5            $485
Physical Therapist..............................................              79               3             237
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8             722
----------------------------------------------------------------------------------------------------------------

    We proposed that each CORF will also have to review and update its 
emergency preparedness communication plan at least annually. We believe 
that compliance with this requirement will constitute a usual and 
customary business practice for CORFs and will not be subject to the 
PRA in accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    Section 485.68(d) will require CORFs to develop and maintain an 
emergency preparedness training and testing program that must be 
reviewed and updated at least annually. We proposed that each CORF will 
have to satisfy the requirements listed at Sec.  485.68(d)(1) and (2).
    Section 485.68(d)(1) will 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 will have to 
provide emergency preparedness training at least annually. Each CORF 
will also have to ensure that its staff could demonstrate knowledge of 
its emergency procedures. All new personnel will 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 will 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 
485.64(b)(1) specifies that CORFs must also provide ongoing training 
and drills 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 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 final rule, all CORFs will need to compare their current training 
programs to their risk assessments, emergency preparedness plans, 
policies and procedures, and communication plans. CORFs will then need 
to revise, and in some cases, develop new material for their training 
programs.
    We expect that these tasks will require the involvement of an 
administrator and a physical therapist. We expect that the 
administrator will review the CORF's current training program to 
identify necessary changes and additions to the program. We expect that 
the physical therapist will work with the administrator to develop the 
revised and updated training program. We estimate it will require 8 
burden hours for each CORF to develop an emergency training program at 
a cost of $722. Therefore, for all CORFs to comply will require an 
estimated 1,640 burden hours (8 burden hours for each CORF x 205 CORFs) 
at a cost of $148,010 ($722 estimated cost for each CORF x 205 CORFs).

                          Table 76--Total Cost Estimate for a CORF To Conduct Training
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               5            $485
Physical Therapist..............................................              79               3             237
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8             722
----------------------------------------------------------------------------------------------------------------

    We also proposed 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, we believe 
complying with the requirement for an annual review of the emergency 
preparedness training program will constitute a usual and customary 
business practice for CORFs and will not be subject to the PRA in 
accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    Section 485.68(d)(2) will require CORFs to participate in a full-
scale exercise and a paper-based, tabletop exercise at least annually. 
If a full-scale exercise was not available, the CORF will have to 
conduct a full-scale exercise at least annually. If a CORF experienced 
an actual natural or man-made emergency that required activation of its 
emergency plan, it will be exempt from engaging in a full-scale 
exercise for 1 year following the onset of the actual event. CORFs will 
also be required to analyze their responses to and maintain 
documentation of all drills, tabletop exercises, and emergency

[[Page 63977]]

events, and revise their emergency plans, as needed. To comply with 
this requirement, a CORF will need to develop scenarios for these 
drills and exercises. The current CoPs at Sec.  485.64(b)(1) require 
CORFs to provide ongoing training and 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 
will develop the scenarios for the drills and exercises, as well as the 
accompanying documentation. We expect that the administrator will spend 
more time on these tasks than the physical therapist. We estimate that 
for each CORF to comply with the requirements will require 6 burden 
hours at a cost of $546. Therefore, for all 205 CORFs to comply will 
require an estimated 1,230 burden hours (6 burden hours for each CORF x 
205 CORFs) at a cost of $111,930 ($528 estimated cost for each CORF x 
221 CORFs).
    Based on the previous analysis, for all 205 CORFs to comply with 
the ICRs contained in this final rule will require 10,250 total burden 
hours at a total cost of $931,520.

                           Table 77--Total Cost Estimate for a CORF To Conduct Testing
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               4            $388
Physical Therapist..............................................              79               2             158
                                                                 -----------------------------------------------
    Total.......................................................  ..............               6             546
----------------------------------------------------------------------------------------------------------------


    Table 78--Burden Hours and Cost Estimates for all 205 CORFS To Comply With the ICRs Contained in Sec.   485.68 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                                                         Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      Respondents   Responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   485.68(a)(1)................  0938--New.............           205          205            8        1,640           **       148,010      148,010
Sec.   485.68(a)(2)-(4)............  0938--New.............           205          205           11        2,255           **       207,665      207,665
Sec.   485.68(b)...................  0938--New.............           205          205            9        1,845           **       167,895      167,895
Sec.   485.68(c)...................  0938--New.............           205          205            8        1,640           **       148,010      148,010
Sec.   485.68(d)(1)................  0938--New.............           205          205            8        1,640           **       148,010      148,010
Sec.   485.68(d)(2)................  0938--New.............           205          205            6        1,230           **       111,930      111,930
                                                            --------------------------------------------------------------------------------------------
    Totals.........................  ......................           205        1,230  ...........       10,250  ............  ...........      931,520
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 78.

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

    Section 485.625(a) will require critical access hospitals (CAHs) to 
develop and maintain a comprehensive emergency preparedness program 
that utilizes an all-hazards approach and will have to be reviewed and 
updated at least annually. Each CAH's emergency plan will have to 
include the elements listed at Sec.  485.625(a)(1) through (4).
    Section 485.625(a)(1) will require each CAH to develop a 
documented, facility-based and community-based risk assessment 
utilizing an all-hazards approach. CAHs will need to review their 
existing risk assessments and perform any tasks necessary to ensure 
that it complied with our requirements.
    As of June 2016, there are approximately 1,337 CAHs. CAHs with 
distinct part units were included in the hospital burden analysis. 
Approximately 445 CAHs are accredited either by TJC (338), DNV GL (76), 
or by the AOA/HFAP (31); the remainder are non-accredited CAHs.
    Many of the TJC and AOA/HFAP accreditation standards for CAHs are 
similar to the requirements in this final rule. For purposes of 
determining the burden, we have analyzed the burden for the 338 TJC-
accredited and 31 AOA/HFAP-accredited CAHs separately from the non-
accredited CAHs. DNV GL's accreditation standards do not meet the 
requirements for emergency preparedness of this final rule and as a 
result, we have included the DNV GL-accredited CAHs with the non-
accredited CAHs in our burden analysis. Note that we obtained 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''

[[Page 63978]]

(CAMCAH, Emergency Management, Introduction, p. EC-10). Thus, we expect 
that TJC-accredited CAHs already conduct a risk assessment that will 
comply with the requirements we proposed. Thus, for the 338 TJC-
accredited CAHs, the risk assessment requirement will constitute a 
usual and customary business practice and will not be subject to the 
PRA in accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    For purposes of determining the burden for AOA/HFAP-accredited 
CAHs, we used the AOA/HFAP'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/HFAP-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/HFAP-accredited CAHs 
already perform some type of risk assessment. However, the AOA/HFAP 
standards do not require a documented facility-based and community-
based risk assessment, as we proposed. Therefore, we will include the 
31 AOA/HFAP-accredited CAHs with non-accredited CAHs in determining the 
burden for our risk assessment requirement.
    The CAH CoPs currently require CAHs to assure the safety of their 
patients in nonmedical 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 (Sec.  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 will satisfy our requirements.
    We believe that under this final rule, the 999 non TJC-accredited 
CAHs (1,337 CAHs-338 TJC-accredited CAHs) will 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 will 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 
will require the involvement of a CAH's administrator, medical 
director, director of nursing, facilities director, and food services 
director. We expect that these individuals will 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 will 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 for non TJC-
accredited CAHs will require 15 burden hours to complete at a cost of 
$1,495. We estimate that for the 999 non TJC-accredited CAHs to comply 
with the risk assessment requirement will require 14,985 burden hours 
(15 burden hours for each CAH x 999 non TJC-accredited CAHs) at a cost 
of $1,493,505 ($1,495 estimated cost for each non TJC-accredited CAH x 
999 non TJC-accredited CAHs).

             Table 79--Total Cost Estimate for a Non-TJC Accredited CAH To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               5            $485
Medical Director................................................             181               2             362
Director of Nursing.............................................              97               3             291
Facility Director...............................................              83               3             249
Food Services Director..........................................              54               2             108
                                                                 -----------------------------------------------
    Total.......................................................  ..............              15           1,495
----------------------------------------------------------------------------------------------------------------

    After conducting the risk assessment, CAHs will have to develop and 
maintain emergency preparedness plans that comply with Sec.  
485.625(a)(1) through (4). We will 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 requirements.
    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 338 TJC-accredited CAHs already have 
emergency preparedness plans that will satisfy our requirements. If a 
CAH needed to complete additional tasks to comply with the requirement, 
the burden will be negligible. Thus, for the 338 TJC-accredited CAHs, 
this requirement will constitute a usual and customary business 
practice and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    The AOA/HFAP-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/HFAP-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 healthcare settings (ARCAH, Standard

[[Page 63979]]

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/HFAP 
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/HFAP-accredited CAHs will 
have to compare their risk assessments they conducted in accordance 
with 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 31 AOA/HFAP-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 999 non-
accredited CAHs will 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 will 
satisfy our requirements.
    Based on our experience with CAHs, we expect that the same 
individuals who were involved in conducting the risk assessment will be 
involved in developing the emergency preparedness plan. We expect that 
these individuals will 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 will 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 will require 26 burden hours at a cost of $2,561. 
Therefore, we estimate that for all 999 non TJC-accredited CAHs to 
comply with this requirement will require 25,974 burden hours (26 
burden hours for each non TJC-accredited CAH x 999 non TJC-accredited 
CAHs) at a cost of $2,558,439 ($2,561 estimated cost for each non TJC-
accredited CAH x 999 non TJC-accredited CAHs).

      Table 80--Total Cost Estimate for a Non-TJC Accredited CAH To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               8            $776
Medical Director................................................             181               3             543
Director of Nursing.............................................              97               6             582
Facility Director...............................................              83               6             498
Food Services Director..........................................              54               3             162
                                                                 -----------------------------------------------
    Total.......................................................  ..............              26        2,561.00
----------------------------------------------------------------------------------------------------------------

    Under this final rule, CAHs also will 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 that is responsible that 
is for the periodic review of their total program. Therefore, we 
believe that this requirement will constitute a usual and customary 
business practice for CAHs and will not be subject to the PRA in 
accordance with the implementing regulations of the PRA 5 CFR 
1320.3(b)(2).
    Under Sec.  485.625(b), we will 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 will also 
require CAHs to review and update these policies and procedures at 
least annually. These policies and procedures will have to address, at 
a minimum, the requirements listed at Sec.  485.625(b)(1) through (8).
    We expect that all CAHs will review their policies and procedures 
and compare them to their risk assessments, emergency preparedness 
plans, and emergency communication plans. The CAHs will 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 
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 proposed have a corresponding requirement in the CAH TJC 
accreditation standards.
    We proposed 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 will be in compliance with our 
requirement concerning subsistence needs at Sec.  485.625(b)(1).

[[Page 63980]]

    We are proposing at Sec.  485.625(b)(2) that CAHs have policies and 
procedures for a system to track the location of on-duty staff and 
sheltered patients in the CAH's care during 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 
will be in compliance with our requirement.
    Section 485.625(b)(3) will 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 will be in 
compliance with our requirement.
    We proposed 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 will be substantially in compliance with our 
requirement.
    Section 485.625(b)(5) will 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 will be substantially in compliance with Sec.  
485.625(b)(5).
    Section 485.625(b)(6) will 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 
requirements, we do not believe TJC-accredited CAHs will be in 
compliance with all requirements in Sec.  485.625(b)(6).
    Based upon the previous discussion, we expect that the activities 
required for compliance by TJC-accredited CAHs with Sec.  485.625(b)(1) 
through (5) constitutes usual and customary business practices for PRAs 
and will not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2).
    However, we do not believe TJC-accredited CAHs will be 
substantially in compliance with 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/HFAP accreditation standards also contain requirements for 
policies and procedures related to safety and disaster preparedness. 
The AOA/HFAP-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/HFAP-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 will 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 requirements for policies and 
procedures.
    In regard to Sec.  485.625(b)(1), AOA/HFAP-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 requirements in this 
section.
    In regard to Sec.  485.625(b)(2), AOA/HFAP-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 Sec.  485.625(b)(3), which requires policies and 
procedures regarding the safe evacuation from the facility, AOA/HFAP-
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/HFAP-accredited CAHs

[[Page 63981]]

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/HFAP-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/HFAP-accredited CAHs are compliant with our 
requirements.
    In regard to Sec.  485.625(b)(4), AOA/HFAP-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/HFAP-accredited CAHs have likely 
already incorporated many of the elements necessary to satisfy the 
requirements in Sec.  485.625(b); however, they will need to thoroughly 
review their current policies and procedures and perform whatever tasks 
are necessary to ensure that they complied with all of our requirements 
for emergency policies and procedures. Because we expect that AOA/HFAP-
accredited CAHs already comply with many of our requirements, we will 
include the AOA/HFAP-accredited CAHs with the TJC-accredited CAHs in 
determining the burden.
    The burden for the 31 AOA/HFAP-accredited CAHs and the 338 TJC-
accredited CAHs to comply with all of the requirements in Sec.  
485.625(b) will be the resources required to develop written policies 
and procedures that comply with all of our requirements for emergency 
policies and procedures. Based on our experience working with CAHs, we 
expect that accomplishing these activities will require the involvement 
of an administrator, the medical director, director of nursing, 
facilities director, and food services director. We expect that the 
administrator will review the policies and procedures and make 
recommendations for necessary changes or additional policies or 
procedures. The CAH administrator will 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 will require 10 burden hours for each 
TJC and AOA/HFAP-accredited CAH at a cost of $983. For all 369 TJC and 
AOA/HFAP-accredited CAHs to comply with these requirements will require 
an estimated 3,690 burden hours (10 burden hours for each TJC or AOA/
HFAP-accredited CAH x 369 TJC and AOA/HFAP-accredited CAHs) at a cost 
of $362,727 ($983 estimated cost for each TJC or AOA/HFAP-accredited 
CAH x 369 TJC and AOA/HFAP-accredited CAHs).

             Table 81--Total Cost Estimate for an Accredited CAH To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               4            $388
Medical Director................................................             181               1             181
Director of Nursing.............................................              97               2             194
Facility Director...............................................              83               2             166
Food Services Director..........................................              54               1              54
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10          983.00
----------------------------------------------------------------------------------------------------------------

    We expect that the 892 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. Sec.  
485.627(a), 485.635(a), and 485.641(a)(1)(iii)). In addition, certain 
activities associated with our 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 will be the resources needed to review, revise, and if 
needed, develop emergency preparedness policies and procedures that 
include our requirements. We believe the individuals and tasks will be 
the same as described earlier for the TJC and AOA/HFAP-accredited CAHs. 
However, the non-accredited CAHs will require more time to accomplish 
these activities. We estimate that a non-accredited CAH's compliance 
will require 14 burden hours at a cost of $1,357. For all 892 
unaccredited CAHs to comply with this requirement will require an 
estimated 12,488 burden hours (14 burden hours for each non-accredited 
CAHs x 892 non-accredited CAHs) at a cost of $1,210,444 ($1,357 
estimated cost for each non-accredited CAH x 892 non-accredited CAHs).

            Table 82--Total Cost Estimate for a Non-Accredited CAH To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               6            $582
Medical Director................................................             181               1             181
Director of Nursing.............................................              97               3             291
Facility Director...............................................              83               3             249
Food Services Director..........................................              54               1              54
                                                                 -----------------------------------------------

[[Page 63982]]

 
    Total.......................................................  ..............              14           1,357
----------------------------------------------------------------------------------------------------------------

    Section 485.625(b) will also require CAHs to review and update 
their emergency preparedness policies and procedures at least annually. 
As discussed earlier, TJC and AOA/HFAP-accredited CAHs already 
periodically review their policies and procedures. In addition, the 
existing CAH CoPs require periodic reviews of the CAH's healthcare 
policies (Sec. Sec.  485.627(a), 485.635(a), and 485.641(a)(1)(iii)). 
Thus, we believe compliance with this requirement will constitute a 
usual and customary business practice for all CAHs and will not be 
subject to the PRA in accordance with the implementing regulations of 
the PRA at 5 CFR 1320.3(b)(2).
    Section 485.625(c) will require CAHs to develop and maintain 
emergency preparedness communication plans that complied with both 
federal and state law. We proposed that CAHs review and update these 
plans at least annually. We proposed that these communication plans 
include the information listed at Sec.  485.625(c)(1) through (7).
    We expect that all CAHs will review their emergency preparedness 
communication plans and compare them to their risk assessments and 
emergency plans. We also expect that CAHs will revise and, if 
necessary, develop new sections that will comply with our requirements. 
Based on our experience with CAHs, they have some type of emergency 
preparedness communication plan. Furthermore, it is standard practice 
for healthcare 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 healthcare providers to ensure continuity of 
care for their patients. Thus, we believe that most, if not all, CAHs 
are already in compliance with Sec.  485.625(c)(1) through (3).
    However, all CAHs will need to review and, if needed, revise and 
update their plans to ensure compliance with 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 will ensure compliance 
with Sec.  485.625(c)(4) through (7). Thus, we will include the 338 
TJC-accredited CAHs in the burden of this final rule.
    The AOA/HFAP-accredited CAHs must develop and implement 
communication plans to ensure the safety of their patients during 
emergencies (AOA/HFAP Standard 11.02.02). These plans must specifically 
include both internal and external communications (AOA/HFAP Standard 
11.02.02, Elements 6, 7, and 10). Based on these standards, we do not 
believe they ensure compliance with Sec.  485.625(c)(4) through (7). 
Thus, we will include these 31 AOA/HFAP-accredited CAHs in the burden 
of this final rule.
    The burden associated with complying with this requirement will 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 will require the 
involvement of an administrator, director of nursing, and the 
facilities director. We expect that the administrator will review the 
communication plan and make recommendations for necessary changes or 
additions. The director of nursing and the facilities director will 
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 will require 9 burden hours for each 
CAH at a cost of $831. We estimate that for all 1,337 CAHs to comply 
with the requirements for an emergency preparedness communication plan 
will require 12,033 burden hours (9 burden hours for each CAH x 1,337 
CAHs) at a cost of $1,111,047 ($831 estimated cost for each CAH x 1,337 
CAHs).

                     Table 83--Total Cost Estimate for a CAH To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               3            $291
Director of Nursing.............................................              97               3             291
Facility Director...............................................              83               3             249
                                                                 -----------------------------------------------
    Total.......................................................  ..............               9             831
----------------------------------------------------------------------------------------------------------------

    Section 485.625(c) also will 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, we believe compliance with this 
requirement will constitute a usual and customary business practice for 
CAHs and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 485.625(d) will require CAHs to develop and maintain 
emergency preparedness training and testing programs. We will also 
require CAHs to review and update their training and testing programs 
at least annually. We proposed that a CAH comply with the requirements 
listed at Sec.  485.625(d)(1) and (2).
    Regarding Sec.  485.625(d)(1), CAHs will 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

[[Page 63983]]

expected roles, and maintain documentation of the training. Thereafter, 
the CAH will have to provide emergency preparedness training at least 
annually.
    We expect that all CAHs will 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 will need to revise and, if necessary, develop new 
sections or materials to ensure their training and testing programs 
complied with our 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/HFAP 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/HFAP-accredited CAHs are required to provide an 
education program for their staff and physicians for the CAH's 
emergency response preparedness (AOA/HFAP Standard 11.07.01). Each CAH 
also must provide an education program specifically for the CAH's 
response plan for weapons of mass destruction (AOA Standard 11.07.07).
    Thus, we expect that all CAHs provide some emergency preparedness 
training for their staff. However, neither the current CoPs nor the TJC 
and AOA/HFAP accreditation standards ensure compliance with all our 
requirements. All CAHs will 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 
requirements. They also will 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 requirement will require the involvement of an administrator, the 
director of nursing, and the facilities director. We expect that the 
director of nursing will 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 will require 14 burden 
hours to develop an emergency preparedness training program at a cost 
of $1,316. Therefore, for all 1,337 CAHs to comply with this 
requirement will require an estimated 18,718 burden hours (14 burden 
hours for each CAH x 1,337 CAHs) at a cost of $1,759,492 ($1,316 
estimated cost for each CAH x 1,337 CAHs).

                           Table 84--Total Cost Estimate for a CAH To Conduct Training
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               2            $194
Director of Nursing.............................................              97               9             873
Facility Director...............................................              83               3             249
                                                                 -----------------------------------------------
    Total.......................................................  ..............              14           1,316
----------------------------------------------------------------------------------------------------------------

    Section 485.625(d)(1) also will 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, we believe compliance 
with this requirement will constitute a usual and customary business 
practice for CAHs and will not be subject to the PRA in accordance with 
the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    The CAHs also will 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 will be 
negligible. Thus, we believe compliance with this requirement will 
constitute a usual and customary business practice for CAHs and will 
not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 485.625(d)(2) will require CAHs to participate in a full-
scale exercise and a paper-based, tabletop exercise at least annually. 
If a full-scale exercise was not available, the CAH will have to 
conduct a full-scale exercise at least annually. CAHs also will 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 will be exempt from the requirement for a full-scale exercise for 1 
year following the onset of the emergency (Sec.  485.625(d)(2)(ii)). 
Thus, to meet these requirements, CAHs will need to develop scenarios 
for each drill and exercise and develop the required documentation.
    If a CAH participated in a full-scale exercise, it will 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 testing exercises 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, we believe 
compliance with this requirement will constitute a usual and customary 
business practice for TJC-accredited CAHs and will not be subject to 
the PRA in accordance with the implementing regulations of the PRA at 5 
CFR 1320.3(b)(2).
    The AOA/HFAP-accredited CAHs are required to conduct two disaster 
drills annually (AOA/HFAP Standard 11.07.03). In addition, AOA/HFAP-
accredited CAHs are required to participate in weapons of mass 
destruction drills, as appropriate (AOA/HFAP Standard 11.07.09). We 
expect that since AOA/HFAP-accredited CAHs

[[Page 63984]]

already conduct disaster drills, they also develop scenarios for the 
drills. In addition, it is standard practice in the healthcare industry 
to document and analyze tests that a facility conducts. Thus, we 
believe compliance with this requirement will constitute a usual and 
customary business practice for AOA/HFAP-accredited CAHs and will not 
be subject to the PRA in accordance with the implementing regulations 
of the PRA at 5 CFR 1320.3(b)(2).
    Based on our experience with CAHs, we expect that the 892 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 
requirements. Thus, we will analyze the burden for these requirements 
for the 892 non-accredited CAHs.
    The 892 non-accredited CAHs will be required to develop scenarios 
for testing exercises 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 will develop the scenarios for the tests and the accompanying 
documentation. We expect that the director of nursing will spend more 
time than will the other individuals developing the scenarios and the 
accompanying documentation. We estimate that it will require 8 burden 
hours for the 892 non-accredited CAHs to comply with these requirements 
at a cost of $762. Therefore, for all 892 non-accredited CAHs to comply 
with these requirements will require an estimated 7,136 burden hours (8 
burden hours for each non-accredited CAH x 892 non-accredited CAHs) at 
a cost of $679,704 ($762 estimated cost for each non-accredited CAH x 
892 non-accredited CAHs).

                    Table 85--Total Cost Estimate for a Non-Accredited CAH To Conduct Testing
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               1             $97
Director of Nursing.............................................              97               6             582
Facility Director...............................................              83               1              83
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8             762
----------------------------------------------------------------------------------------------------------------


   Table 86--Burden Hours and Cost Estimates for All 1,337 CAHS To Comply With the ICRs Contained in Sec.   485.625 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                         Total    Hourly labor  Total labor
                                                                                           Burden per    annual      cost of      cost of     Total cost
        Regulation section(s)              OMB Control No.      Respondents   Responses     response     burden     reporting    reporting       ($)
                                                                                            (hours)     (hours)        ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   485.625(a)(1).................  0938-New..............           999          999           15     14,985           **     1,493,505    1,493,505
Sec.   485.625(a)(2)-(4).............  0938-New..............           999          999           26     25,974           **     2,558,439    2,558,439
Sec.   485.625(b) (TJC and AOA/HFAP-   0938-New..............           369          369           10      3,690           **       362,727      362,727
 Accredited).
Sec.   485.625(b) (Non-accredited)...  0938-New..............           892          892           14     12,488           **     1,210,444    1,210,444
Sec.   485.625(c)....................  0938-New..............         1,337        1,337            9     12,033           **     1,111,047    1,111,047
Sec.   485.625(d)(1).................  0938-New..............         1,337        1,337           14     18,718           **     1,759,492    1,759,492
Sec.   485.625(d)(2).................  0938-New..............           892          892            8      7,136           **       679,704      679,704
                                                              ------------------------------------------------------------------------------------------
    Total............................  ......................         3,597        6,825  ...........     95,024  ............  ...........    9,175,358
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 86.

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

    Section 485.727(a) will 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).
    Section 485.727(a)(1) will require organizations to develop 
documented, facility-based and community-based risk assessment 
utilizing an all-hazards approach. Organizations will 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 will need to review their current risk assessments and 
make any revisions to ensure they complied with our 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 will 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 will attend an initial meeting, review 
the current assessment, develop comments and

[[Page 63985]]

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 will 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 will spend more time reviewing and working on the risk 
assessment than the physical therapist. We estimate that complying with 
this requirement will require 9 burden hours at a cost of $901. We 
estimate that it will require 19,215 burden hours (9 burden hours for 
each organization x 2,135 organizations) for all organizations to 
comply with this requirement at a cost of $1,710,135 ($901 estimated 
cost for each organization x 2,135 organizations).

                 Table 87--Total Estimated Cost for an Organization To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $94               6            $564
Physical Therapist..............................................              79               3             237
                                                                 -----------------------------------------------
    Total.......................................................  ..............               9             801
----------------------------------------------------------------------------------------------------------------

    After conducting the risk assessment, each organization will 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 requirements. However, all 
organizations will need to review their current plans and compare them 
to their risk assessments. Each organization will need to revise, 
update, and, in some cases, develop new sections to complete a 
comprehensive emergency preparedness plan that complied with our 
requirements.
    Based on our experience with these organizations, we expect that 
the administrator and physical therapist who were involved in 
developing the risk assessment will be involved in developing the 
emergency preparedness plan. However, we expect it will require more 
time to complete the plan and that the administrator will be the most 
heavily involved in reviewing and developing the organization's 
emergency preparedness plan. We estimate that for each organization to 
comply will require 12 burden hours at a cost of $1,083. We estimate 
that it will require 25,620 burden hours (12 burden hours for each 
organization x 2,135 organizations) to complete the plan at a cost of 
$2,312,205 ($1,083 estimated cost for each organization x 2,135 
organizations).

          Table 88--Total Estimated Cost for an Organization To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $94               9            $846
Physical Therapist..............................................              79               3             237
                                                                 -----------------------------------------------
    Total.......................................................  ..............              12           1,083
----------------------------------------------------------------------------------------------------------------

    Each organization will 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, we believe 
complying with this requirement will constitute a usual and customary 
business practice for organizations and will not be subject to the PRA 
in accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    Section 485.727(b) will require organizations to develop and 
implement emergency preparedness policies and procedures based on their 
risk assessments, emergency plans, communication plans as set forth in 
Sec.  485.727(a)(1), (a), and (c), respectively. It will also require 
organizations to review and update these policies and procedures at 
least annually. At a minimum, we will 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 requirements at Sec.  485.727(a)(1) through (5). 
However, all organizations will 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 requirements.
    We expect that the administrator and the physical therapist will be 
primarily involved with reviewing and revising the current policies and 
procedures and, if needed, developing new policies and procedures. We 
estimate that it will require 10 burden hours for each organization to 
comply at a cost of $895. We estimate that for all organizations to 
comply will require 21,350 burden hours (10 burden hours for each 
organization x 2,135 organizations) at a cost of $1,910,825 ($895 
estimated cost for each organization x 2,135 organizations).

[[Page 63986]]



              Table 89--Total Estimated Cost for an Organization To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $94               7            $658
Physical Therapist..............................................              79               3             237
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10             895
----------------------------------------------------------------------------------------------------------------

    We will 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, we believe compliance with this 
requirement will constitute a usual and customary business practice and 
will not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 485.727(c) will require organizations to develop and 
maintain emergency preparedness communication plans that complied with 
both federal and state law and will be reviewed and updated at least 
annually. The communication plan will 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 will need to comply with this 
requirement. In addition, it is standard practice for healthcare 
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 healthcare 
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 
requirements. Therefore, we expect that all organizations will 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 will primarily require 
the involvement of the organization's administrator with the assistance 
of a physical therapist. We estimate that for each organization to 
comply will require 8 burden hours at a cost of $722. We estimate that 
for all 2,135 organizations to comply will require 17,080 burden hours 
(8 burden hours for each organizations x 2,135 organizations) at a cost 
of $1,541,470 ($722 estimated cost for each organization x 2,135 
organizations).

               Table 90--Total Estimated Cost for an Organization To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $94               6            $564
Physical Therapist..............................................              79               2             158
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8             722
----------------------------------------------------------------------------------------------------------------

    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, we believe compliance with this 
requirement will constitute a usual and customary business practice and 
will not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 485.727(d) will 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).
    According to Sec.  485.727(d)(1), organizations will 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 will 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 in case of a disaster (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 will 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 will need to review, revise, and, in some cases, develop 
new material for their training programs so that they comply with our 
requirements.
    We expect that complying with this requirement will require the 
involvement of an administrator and a physical therapist. We expect 
that the administrator will primarily be involved in reviewing the 
organization's current training program and the current emergency 
preparedness program; determining what tasks will need to be performed 
and what materials will need to be developed to comply with our 
requirements; and developing the materials for the training program. We 
expect that the physical therapist will work with the administrator to 
develop the revised and updated training program. We estimate that it 
will require 8 burden hours for each organization to develop a 
comprehensive emergency

[[Page 63987]]

training program at a cost of $722. Therefore, it will require an 
estimated 17,080 burden hours (8 burden hours for each organization x 
2,135 organizations) to comply with this requirement at a cost of 
$1,541,470 ($722 estimated cost for each organization x 2,135 
organizations).

                     Table 91--Total Estimated Cost for an Organization To Conduct Training
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $94               6            $564
Physical Therapist..............................................              79               2             158
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8             722
----------------------------------------------------------------------------------------------------------------

    In Sec.  485.727(d)(1), we also proposed requiring that an 
organization must review and update its emergency preparedness training 
program at least annually. We believe that these providers already 
review their emergency preparedness training programs periodically. 
Thus, we believe compliance with this requirement will constitute a 
usual and customary business practice and will not be subject to the 
PRA in accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    Section 485.727(d)(2) will require organizations to participate in 
a full-scale exercise at least annually. They will also be required to 
conduct one additional exercise of their choice at least annually. If 
an organization experienced an actual natural or man-made emergency 
that required activation of its emergency plan, it will be exempt from 
engaging in a drill for 1 year following the onset of the actual event. 
Organizations also will be required to analyze their response to and 
maintain documentation of all the testing exercises and emergency 
events, and revise their emergency plan, as needed. To comply with this 
requirement, an organization will need to develop scenarios for their 
drills and exercises. An organization also will have to develop the 
documentation necessary for recording and analyzing their responses to 
the testing 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 2,135 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 will be in compliance with our requirements. 
Therefore, we will analyze the burden from these requirements for all 
organizations.
    The 2,135 organizations will be required to develop scenarios for 
testing exercises and the necessary documentation. Based on our 
experience with organizations, we expect that the same individuals who 
develop the emergency preparedness training program will develop the 
scenarios for the drills and exercises and the accompanying 
documentation. We expect that the administrator will spend more time 
than the physical therapist developing the scenarios and the 
documentation. We estimate that for each organization to comply will 
require 3 burden hours at a cost of $267. Based on that estimate, it 
will require 6,405 burden hours (3 burden hours for each organization x 
2,135 organizations) at a cost of $570,045 ($267 estimated cost for 
each organization x 2,135 organizations).

                      Table 92--Total Estimated Cost For An Organization To Conduct Testing
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $90               2            $188
Physical Therapist..............................................              76               1              79
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................................................  ..............               3             267
----------------------------------------------------------------------------------------------------------------


     Table 93--Burden Hours and Cost Estimates for All 2,135 Organizations To Comply With The ICRs Contained in Sec.   485.727 Condition: Emergency
                                                                      Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                                                         Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      Respondents   Responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   485.727(a)(1)...............  0938-New..............         2,135        2,135            9       19,215           **     1,710,135    1,710,135
Sec.   485.727(a)(2)-(4)...........  0938-New..............         2,135        2,135           12       25,620           **     2,312,205    2,312,205
Sec.   485.727(b)..................  0938-New..............         2,135        2,135           10       21,350           **     1,910,825    1,910,825
Sec.   485.727(c)..................  0938-New..............         2,135        2,135            8       17,080           **     1,541,470    1,541,470
Sec.   485.727(d)(1)...............  0938-New..............         2,135        2,135            8       17,080           **     1,541,470    1,541,470
Sec.   485.727(d)(2)...............  0938-New..............         2,135        2,135            3        6,405           **       570,045      570,045
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Totals.........................  ......................         2,135      12,8100  ...........      106,750  ............  ...........    9,586,150
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 93.


[[Page 63988]]

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

    Section 485.920(a) will 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 
proposed 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 will need to 
consider its physical location, the geographical area in which it is 
located and its patient population.
    The burden associated with this requirement will 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 
healthcare 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 requirements. Therefore, we expect that most, if not all, CMHCs 
will 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 requirements.
    We have not designated 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, healthcare organizations will include 
representatives from or obtain input from all major departments. Based 
on our experience with CMHCs, we expect that conducting the risk 
assessment will 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 will 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 will coordinate the 
meetings, do an initial review of the current risk assessment, critique 
the risk assessment, offer suggested revisions, coordinate comments, 
develop the new risk assessment, and assure that the necessary parties 
approve the new risk assessment. It is likely that the CMHC 
administrator will spend more time reviewing and working on the risk 
assessment than the other individuals. We estimate that complying with 
the requirement to conduct a risk assessment will require 10 burden 
hours for a cost of $788. There are currently 198 CMHCs. Therefore, it 
will require an estimated 1,980 burden hours (10 burden hours for each 
CMHC x 198 CMHCs) for all CMHCs to comply with this requirement at a 
cost of $156,024 ($788 estimated cost for each CMHC x 198 CMHCs).

                      Table 94--Total Cost Estimate for a CMHC To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $94               6            $564
Psychiatric Registered Nurse....................................              71               2             142
Social Worker...................................................              41               2              82
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10             788
----------------------------------------------------------------------------------------------------------------

    After conducting the risk assessment, CMHCs will need to develop 
and maintain an emergency preparedness plan that must be reviewed and 
updated at least annually. CMHCs will need to compare their current 
emergency plan, if they have one, to their risk assessment. They will 
then need to revise and, if necessary, develop new sections of their 
plan to ensure it complies with the requirements.
    It is standard practice for healthcare 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. Furthermore, 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 
will have to review their current plan and compare it to their risk 
assessment, as well as to the other requirements in Sec.  485.920(a). 
We expect that most CMHCs will need to update and revise their existing 
emergency plan and, in some cases, develop new sections to comply with 
our requirements.
    The burden associated with this requirement will 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 will be involved 
in developing the emergency preparedness plan. We also expect that 
developing the plan will require more time to complete than the risk 
assessment. We expect that the administrator and a psychiatric nurse 
will spend more time reviewing and developing the CMHC's emergency 
preparedness plan. We expect that the clinical social worker or mental 
health counselor will review the plan and provide comments on it to the 
administrator. We estimate that it will require 15 burden hours for a 
CMHC to develop its emergency plan at a cost of $1,113. Based on this 
estimate, it will require 2,970 burden hours (15 burden hours for each 
CMHC x 198 CMHCs) for all CMHCs to complete their plans at a cost of 
$220,374 ($1,113 estimated cost for each CMHC x 198 CMHCs).

[[Page 63989]]



               Table 95--Total Cost Estimate for a CMHC To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $94               6            $564
Psychiatric Registered Nurse....................................              71               6             426
Social Worker...................................................              41               3             123
                                                                 -----------------------------------------------
    Total.......................................................  ..............              15         220,374
----------------------------------------------------------------------------------------------------------------

    The CMHC will be required to review and update its emergency 
preparedness plan at least annually. For the purpose of determining the 
burden for this 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 will 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 healthcare industry for 
facilities to have professional staff persons who periodically review 
their plans and procedures. However, the current CMHC CoPs do not 
include a requirement for an emergency preparedness plan and as such, 
there is no requirement for an annual review of the plan. Therefore, we 
will analyze the burden from this requirement for all CMHCs.
    Based on our experience with CMHCs, we expect that the same 
individuals who develop the emergency preparedness plan will annually 
review and update the plan. We expect that the administrator and 
registered nurse will spend more time than the social worker on the 
review of the plan and documentation of the plan updates. We estimate 
that for each CMHC to comply will require 5 burden hours at a cost of 
$371. Based on that estimate, it will require 990 burden hours (5 
burden hours for each organization x 198 organizations) at a cost of 
$73,458 ($371 estimated cost for each organization x 198 
organizations).

          Table 96--Total Estimated Cost for a CMHC To Review and Update an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $94               2            $188
Registered Nurse................................................              71               2             142
Social Worker...................................................              41               1              41
                                                                 -----------------------------------------------
    Total.......................................................  ..............               5          371.00
----------------------------------------------------------------------------------------------------------------

    Section 485.920(b) will 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 proposed 
requiring CMHCs to review and update these policies and procedures at 
least annually. The CMHC's policies and procedures will be required to 
address, at a minimum, the requirements listed at Sec.  485.920(b)(1) 
through (7).
    We expect that all CMHCs will compare their current emergency 
preparedness policies and procedures to their emergency preparedness 
plan, communication plan, and their training and testing program. They 
will need to review, revise and, if necessary, develop new policies and 
procedure to ensure they comply with the requirements. The burden 
associated with reviewing, revising, and updating the CMHC's emergency 
policies and procedures will be due to the resources needed to ensure 
they comply with the requirements. We expect that the administrator and 
the psychiatric registered nurse will be involved with reviewing, 
revising and, if needed, developing any new policies and procedures. We 
estimate that for a CMHC to comply with this requirement will require 
12 burden hours at a cost of $944. Therefore, for all 198 CMHCs to 
comply with this requirement will require an estimated 2,376 burden 
hours (12 burden hours for each CMHC x 198 CMHCs) at a cost of $186,912 
($944 estimated cost for each CMHC x 198 CMHCs).

                   Table 97--Total Cost Estimate for a CMHC To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $94               4            $376
Psychiatric Registered Nurse....................................              71               8             568
                                                                 -----------------------------------------------
    Total.......................................................  ..............              12             944
----------------------------------------------------------------------------------------------------------------

    The CMHCs will 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 
will 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

[[Page 63990]]

annual review of the emergency preparedness policies and procedures 
will constitute a usual and customary business practice for CMHCs. As 
stated in the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2), the time, effort, and financial resources necessary to 
comply with a collection of information that will be incurred by 
persons in the normal course of their activities are not subject to the 
PRA.
    Section 485.920(c) will require CMHCs to develop and maintain an 
emergency preparedness communications plan that complies with both 
federal and state law. The CMHC also will 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 will compare their current emergency 
preparedness communications plan, if they have one, to the 
requirements. CMHCs will need to perform any tasks necessary to ensure 
that their communication plans were documented and in compliance with 
the 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 healthcare 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 healthcare providers to ensure continuity of care for their 
patients. However, we expect that all CMHCs will 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 requirement will 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 will require 8 burden 
hours at a cost of $637. Therefore, for all of the CMHCs to comply with 
this requirement will require an estimated 1,584 burden hours (8 burden 
hours for each CMHC x 198 CMHCs) at a cost of $126,126 ($637 estimated 
cost for each CMHC x 198 CMHCs).

                    Table 98--Total Cost Estimate for a CMHC To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $94               4            $282
Psychiatric Registered Nurse....................................              71               5             355
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8             637
----------------------------------------------------------------------------------------------------------------

    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 requirement, we expect that CMHCs will 
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 
will require only a negligible burden. Complying with the requirement 
for an annual review of the emergency preparedness communications plan 
constitutes a usual and customary business practice for CMHCs. As 
stated in the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2), the time, effort, and financial resources necessary to 
comply with a collection of information that will be incurred by 
persons in the normal course of their activities are not subject to the 
PRA.
    Section 485.920(d) will require CMHCs to develop and maintain an 
emergency preparedness training program that must be reviewed and 
updated at least annually. We will require the CMHC to meet the 
requirements contained in Sec.  485.920(d)(1) and (2).
    We expect that CMHCs will develop a comprehensive emergency 
preparedness training program. The CMHCs will 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 requirements.
    The burden will be due to the resources the CMHC will need to 
comply with the requirements. We expect that complying with this 
requirement will include the involvement of a psychiatric registered 
nurse. We expect that the psychiatric registered nurse will 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 will require 10 burden hours for each CMHC to develop 
a comprehensive emergency training program at a cost of $710. 
Therefore, it will require an estimated 1,980 burden hours (10 burden 
hours for each CMHC x 198 CMHCs) to comply with this requirement at a 
cost of $140,580 ($710 estimated cost for each CMHC x 198 CMHCs).

                     Table 99--Total Cost Estimate for a CMHC To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Psychiatric Registered Nurse....................................             $71              10            $710
                                                                 -----------------------------------------------

[[Page 63991]]

 
    Total.......................................................  ..............              10             710
----------------------------------------------------------------------------------------------------------------

    Section 485.920(d)(1) will 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 requirement, we will 
expect that CMHCs will 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 will 
require only a negligible burden. Thus, we expect that complying with 
the requirement for an annual review of the emergency preparedness 
training program constitutes a usual and customary business practice 
for CMHCs. As stated in the implementing regulations of the PRA at 5 
CFR 1320.3(b)(2), the time, effort, and financial resources necessary 
to comply with a collection of information that will be incurred by 
persons in the normal course of their activities are not subject to the 
PRA.
    Section 485.920(d)(2) will require CMHCs to participate in or 
conduct a full-scale exercise at least annually. CMHCs are also 
required to participate in one additional testing exercise of their 
choice at least annually. CMHCs will be required to document the drills 
and the exercises. To comply with this requirement, a CMHC will need to 
develop a specific scenario for each drill and exercise. A CMHC will 
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 198 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 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 will be the time and effort necessary to 
comply with the requirement. We expect that complying with this 
requirement will likely require the involvement of a psychiatric 
registered nurse. We expect that the psychiatric registered nurse will 
develop the documentation necessary for both during the testing 
exercises and for the subsequent analysis of the CMHC's response. The 
psychiatric registered nurse will also develop the two scenarios for 
the drill and exercise. We estimate that these tasks will require 4 
burden hours at a cost of $284. For all 198 CMHCs to comply with this 
requirement will require an estimated 792 burden hours (4 burden hours 
for each CMHC x 198 CMHCs) at a cost of $56,232 ($284 estimated cost 
for each CMHC x 198 CMHCs).

                          Table 100--Total Cost Estimate for a CMHC To Conduct Testing
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Psychiatric Registered Nurse....................................             $71               4            $284
                                                                 -----------------------------------------------
    Total.......................................................  ..............               4             284
----------------------------------------------------------------------------------------------------------------


         Table 101--Burden Hours and Cost Estimates for all 198 CMHCs To Comply With the ICRs Contained in Sec.   485.920 Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                                                         Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      Respondents   Responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   485.920(a)..................  0938-New..............           198          198            5          990           **        73,458       73,458
Sec.   485.920(a)(1)...............  0938-New..............           198          198           10        1,980           **       156,024      156,024
Sec.   485.920(a)(1)-(4)...........  0938-New..............           198          198           15        2,970           **       220,374      220,374
Sec.   485.920(b)..................  0938-New..............           198          198           12        2,376           **       186,912      186,912
Sec.   485.920(c)..................  0938-New..............           198          198            8        1,584           **       126,126      126,126
Sec.   485.920(d)(1)...............  0938-New..............           198          198           10        1,980           **       140,580      140,580
Sec.   485.920(d)(2)...............  0938-New..............           198          198            4          792           **        56,232       56,232
                                                            --------------------------------------------------------------------------------------------
    Totals.........................  ......................           198        1,188  ...........       12,672  ............  ...........      959,706
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 101.


[[Page 63992]]

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

    Section 486.360(a) will require Organ Procurement Organizations 
(OPOs) to develop and maintain emergency preparedness plans that will 
have to be reviewed and updated at least annually. These plans will 
have to comply with the requirements listed in Sec.  486.360(a)(1) 
through (4).
    As of June 2016, there are 58 OPOs. The current OPO Conditions for 
Coverage (CfCs) are located at Sec. Sec.  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 final rule.
    Section 486.360(a)(1) will require OPOs to develop a documented, 
facility-based and community-based risk assessment utilizing an all-
hazards approach. OPOs will 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 will 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 Sec.  486.360(a). Therefore, 
we expect that all 58 OPOs will 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 final rule. Based on our experience with OPOs, we believe that 
conducting a risk assessment will 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 will 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 will 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 will require 10 
burden hours for each OPO to conduct a risk assessment at a cost of 
$1,190. Therefore, for all 58 OPOs to comply with the risk assessment 
requirement in this section will require an estimated 580 burden hours 
(10 burden hours for each OPO x 58 OPOs) at a cost of $69,020 ($1,190 
estimated cost for each OPO x 58 OPOs).

                     Table 102--Total Cost Estimate for an OPO To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Director........................................................            $106               2            $212
Medical Director/Physician......................................             207               2             414
QAPI Director...................................................              94               4             376
Organ Procurement Coordinator...................................              94               2             188
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10           1,190
----------------------------------------------------------------------------------------------------------------

    After conducting the risk assessment, OPOs will then have to 
develop emergency preparedness plans. The burden associated with this 
requirement will be the resources needed to develop an emergency 
preparedness plan that complied with the requirements in 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 
healthcare 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 will have emergency preparedness plans that 
will satisfy the requirements of this section. Therefore, we expect 
that all OPOs will need to review their current emergency preparedness 
plans and compare their plans to their risk assessments. Most OPOs will 
need to revise, and in some cases develop, new sections to ensure their 
plan satisfied the requirements.
    We expect that the same individuals who were involved in the risk 
assessment will be involved in developing the emergency preparedness 
plan. We expect that these individuals will 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 will 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 will 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 $2,568. The difference in 
burden between the risk assessment and the plan requirement is greater 
in this section because OPOs have multiple locations and personnel in 
various locations. Therefore, for all 58 OPOs to comply with this 
requirement will require an estimated 1,276 burden hours (22 burden 
hours for each OPO x 58 OPOs) at a cost of $148,944 ($2,568 estimated 
cost for each OPO x 58 OPOs).

               Table 103--Total Cost Estimate for an OPO To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Director........................................................            $106               4            $424
Medical Director/Physician......................................             207               4             828

[[Page 63993]]

 
QAPI Director...................................................              94              10             940
Organ Procurement Coordinator...................................              94               4             376
                                                                 -----------------------------------------------
    Total.......................................................  ..............              22           2,568
----------------------------------------------------------------------------------------------------------------

    The OPOs will 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. 
However, the current OPO CoPs do not include a requirement for an 
emergency preparedness plan and as such, there is no requirement for an 
annual review of the plan. Therefore, we will analyze the burden from 
this requirement for all OPOs.
    Based on our experience with OPOs, we expect that the same 
individuals who develop the emergency preparedness plan will annually 
review and update the plan. We expect that the QAPI director will spend 
more time than the director, medical director, and organ procurement 
coordinator on the review of the plan and documentation of the plan 
updates. We estimate that for each OPO to comply will require 6 burden 
hours at a cost of $689. Based on that estimate, it will require 348 
burden hours (6 burden hours for each organization x 58 organizations) 
at a cost of $39,962 ($689 estimated cost for each organization x 58 
organizations).

         Table 104--Total Estimated Cost for an OPO To Review and Update an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Director........................................................            $106               1            $106
Medical Director/Physician......................................             207               1             207
QAPI Director...................................................              94               3             282
Organ Procurement Coordinator...................................              94               1              94
                                                                 -----------------------------------------------
    Total.......................................................  ..............               6             689
----------------------------------------------------------------------------------------------------------------

    Section 486.360(b) will 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 Sec.  486.360(a)(1), (a), and (c), respectively. It 
will 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 body 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 will be needed 
to comply with the requirements of this section.
    The burden associated with the development of the emergency 
preparedness policies and procedures will be the resources needed to 
develop emergency preparedness policies and procedures that will 
include, but will not be limited to, the specific elements identified 
in this requirement. We expect that all OPOs will 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 final rule. Following their reviews, OPOs will 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 will 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 will 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 will 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 will require 20 burden hours for each OPO 
to comply with the requirement to develop emergency preparedness 
policies and procedures at a cost of $2,154. Therefore, for all 58 OPOs 
to comply with this requirement will require an estimated 1,160 burden 
hours (20 burden hours for each OPO x 58 OPOs) at a cost of $124,932 
(estimated cost for each OPO of $2,154 x 58 OPOs).

                  Table 105--Total Cost Estimate for an OPO To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Director........................................................            $106               4            $424
Medical Director/Physician......................................             207               2             414

[[Page 63994]]

 
QAPI Director...................................................              94               8             752
Organ Procurement Coordinator...................................              94               6             564
                                                                 -----------------------------------------------
    Total.......................................................  ..............              20           2,154
----------------------------------------------------------------------------------------------------------------

    The OPOs also will 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, we believe compliance with this 
requirement will constitute a usual and customary business practice and 
will not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 486.360(c) will require OPOs to develop and maintain 
emergency preparedness communication plans that complied with both 
federal and state law. The OPOs will have to review and update their 
plans at least annually. The communication plans will have to include 
the information listed in Sec.  486.360(c)(1) through (3).
    The OPOs must operate 24 hours a day, 7 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 will ensure that all 
OPOs have already addressed at least some of the elements that will be 
required by this section. For example, due to the necessity of 
communication with so many other entities, we expect that all OPOs will 
have compiled names and contact information for staff, other OPOs, and 
transplant programs.
    We also expect that all OPOs will 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 elements 
contained in this requirement. The burden will be the resources needed 
to develop an emergency preparedness communications plan that will 
include, but not be limited to, the specific elements identified in 
this section. We expect that this will require the involvement of the 
OPO director, medical director, QAPI director, and OPC. We expect that 
all of these individuals will 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 Sec.  486.360(e), and 
the OPO's emergency preparedness policies and procedures. We expect 
that these individuals will 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 
will 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 will require 14 burden hours to develop an 
emergency preparedness communication plan at a cost of $1,566. 
Therefore, it will require an estimated 812 burden hours (14 burden 
hours for each OPO x 58 OPOs) at a cost of $90,828 ($1,566 estimated 
cost for each OPO x 58 OPOs).

                    Table 106--Total Cost Estimate for an OPO To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Director........................................................            $106               2            $212
Medical Director/Physician......................................             207               2             414
QAPI Director...................................................              94               6             564
Organ Procurement Coordinator...................................              94               4             376
                                                                 -----------------------------------------------
    Total.......................................................  ..............              14           1,566
----------------------------------------------------------------------------------------------------------------

    We proposed that OPOs must review and update their emergency 
preparedness communication plans at least annually. We believe that all 
of the OPOs already review their emergency preparedness communication 
plans periodically. Thus, we believe compliance with this requirement 
will constitute a usual and customary business practice for OPOs and 
will not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 486.360(d) will require OPOs to develop and maintain 
emergency preparedness training and testing programs. OPOs also will 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 proposed 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 will 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,

[[Page 63995]]

we do not believe that the content of their existing training will 
comply with the requirements.
    We expect that OPOs will develop a comprehensive emergency 
preparedness training program for their staffs. Based upon our 
experience with OPOs, we expect that complying with this requirement 
will 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 will 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 will 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 will require 40 burden hours for each OPO to 
develop an emergency preparedness training program that complied with 
these requirements at a cost of $3,154. Therefore, we estimate that for 
all 58 OPOs to comply with this requirement will require 2,320burden 
hours (40 burden hours for each OPO x 58 OPOs) at a cost of $203,812 
($3,514 estimated cost for each OPO x 58 OPOs).

                     Table 107--Total Cost Estimate for an OPO To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Director........................................................            $106               2            $212
Medical Director/Physician......................................             207               2             414
QAPI Director...................................................              94              12           1,128
Organ Procurement Coordinator...................................              94               8             752
Education Coordinator...........................................              63              16           1,008
                                                                 -----------------------------------------------
    Total.......................................................  ..............              40           3,514
----------------------------------------------------------------------------------------------------------------

    We proposed 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, we believe compliance with this 
requirement will constitute a usual and customary business practice for 
OPOs and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 486.360(d)(2) will require OPOs to conduct a paper-based, 
tabletop exercise at least annually. OPOs also will 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 will 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 
will include developing a scenario for and documenting the exercise. 
Thus, we believe compliance with these requirements will constitute a 
usual and customary business practice and will not be subject to the 
PRA in accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
    We expect that the QAPI director and the education coordinator will 
work together to develop the scenario for the exercise and the 
necessary documentation. We expect that the QAPI director will likely 
spend more time on these activities. We estimate that these tasks will 
require 5 burden hours for each OPO at a cost of $408. For all 58 OPOs 
to comply with these requirements will require an estimated 290 burden 
hours (5 burden hours for each OPO x 58 OPOs) at a cost of $23,664 
($408 estimated cost for each OPO x 58 OPOs).

                          Table 108--Total Cost Estimate for an OPO To Conduct Testing
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
QAPI Director...................................................             $94               3            $282
Education Coordinator...........................................              63               2             126
                                                                 -----------------------------------------------
    Total.......................................................  ..............               5             408
----------------------------------------------------------------------------------------------------------------

    Section 486.360(e) requires OPOs to develop and maintain mutually 
agreed upon protocols as required in Sec.  486.344(d) that cover the 
duties and responsibilities of the transplant program, the hospital in 
which the transplant program is operated and the OPO during an 
emergency. Section 486.344(d) does not currently require that emergency 
preparedness be addressed in those protocols. Thus, we believe that 
most OPOs do not currently address emergency preparedness in their 
protocols. OPOs will only be required to address emergency preparedness 
with the transplant centers and the hospitals in which they operate. 
Since the number of transplant hospitals varies between the DSAs and 
the number of transplant programs in each of those hospitals also 
varies, we have estimated the burden based on the average number of 
transplant hospitals for each DSA and the number of transplant programs 
in those hospitals. There are about 770 transplant programs and 234 
transplant hospitals. For each OPO's DSA, there is an average of 4 
transplant hospitals (234 transplant hospitals/58 OPOs) with 3 
transplant programs (770 transplant programs/234 transplant hospitals). 
Thus, we estimate that each OPO would need to develop

[[Page 63996]]

protocols for 12 transplant programs (4 transplant hospitals for each 
DSA x 3 transplant programs in each transplant hospital).
    The burden associated with this requirement will be the time and 
effort necessary to negotiate with each hospital and transplant 
program, and then draft the protocols that address each one's duties 
and responsibilities during an emergency. Based on our experience with 
OPOs, transplant centers, and the hospitals in which they operate, we 
believe that they have already had to deal with some type of emergency 
and have a basis for those protocols, especially the types of services 
that are needed by the waiting list patients and the transplant 
recipients and the services that each of them can provide during an 
emergency. Based on our experience with OPOs, we believe that 
conducting these negotiations would require the involvement of the 
OPO's director, medical director, QAPI director, and an organ 
procurement coordinator (OPC). We expect that these individuals would 
attend an initial meeting and then one individual, probably the QAPI 
director, would draft the protocols and ensure they are reviewed by all 
required parties and agreed to. This would require an hour of each 
individual's time, except for the QAPI director who would require 2 
hours for each transplant program. Thus, for each transplant program, 
the OPO would need 5 burden hours at a cost of $595. As described 
previously, each OPO would need to develop protocols for 12 transplant 
programs. Thus, to comply with this requirement, each OPO would require 
60 burden hours (5 burden hours x 12 transplant programs) at a cost of 
$7,140 ($595 for each transplant program x 12 transplant programs). For 
all 58 OPOs, we estimate that the total burden to develop these 
protocols would be 3,480 burden hours (60 burden hours for each OPO x 
58 OPOs) at a cost of $414,120 ($7,140 for each OPO x 58 OPOs).

        Table 109--Total Cost Estimate for an OPO To Develop and Maintain Mutually Agreed Upon Protocols
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Director........................................................            $106               1            $106
Medical Director/Physician......................................             207               1             207
QAPI Director...................................................              94               2             188
Organ Procurement Coordinator...................................              94               1              94
                                                                 -----------------------------------------------
    Total.......................................................  ..............               5             595
----------------------------------------------------------------------------------------------------------------

    Section 486.360(e) will also require each OPO to have the 
capability to continue its operations from an alternate location during 
an emergency. The OPO can have an agreement 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. However, based upon comments that we received, we 
are also finalizing two alternate means by which an OPO can also comply 
with this requirement. An OPO with more than one location or office 
would satisfy this requirement if it had at least one other location or 
office from which the OPO could conduct its operations, or at least 
those services the OPO has deemed essential to provide, during an 
emergency. An OPO could also satisfy this requirement by having a plan, 
which has been positively tested, to locate to an alternate location 
during an emergency as part of its emergency plan as required by Sec.  
486.360(a). According to the commenters, some OPOs, especially those in 
DSAs that cover large geographical areas, already have more than one 
office or location. In addition, since OPOs will have to address 
continuity of operations in their emergency plans under Sec.  
486.360(a), we believe that virtually all of the OPOs will chose to 
comply with this requirement by one of the two alternate methods being 
finalized. We estimate that about 9 OPOs or 15 percent of all OPOs 
would chose to have an agreement with another OPO. Since we estimate 
that fewer than 10 OPOs would chose to have an agreement with another 
OPO, this requirement is not subject to the PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(c).

          Table 110--Burden Hours and Cost Estimates for all 58 OPOs To Comply With The ICRs Contained in Sec.   486.360 Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                                                         Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      Respondents   Responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   486.360(a)..................  0938-New..............            58           58            6          348           **        39,962       39,962
Sec.   486.360(a)(1)...............  0938-New..............            58           58           10          580           **        69,020       69,020
Sec.   486.360(a)(2)-(4)...........  0938-New..............            58           58           22        1,276           **       148,944      148,944
Sec.   486.360(b)..................  0938-New..............            58           58           20        1,160           **       124,932      124,932
Sec.   486.360(c)..................  0938-New..............            58           58           14          812           **        90,828       90,828
Sec.   486.360(d)(1)...............  0938-New..............            58           58           40        2,320           **       203,812      203,812
Sec.   486.360(d)(2)...............  0938-New..............            58           58            5          290           **        23,664       23,664
Sec.   486.360(e)..................  0938-New..............            58           58           60        3,480           **       414,120      414,120
                                                            --------------------------------------------------------------------------------------------
    Totals.........................  ......................            58          406  ...........       10,266  ............  ...........    1,115,282
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 110.


[[Page 63997]]

R. ICRs Regarding Condition for Coverage and Condition for 
Certification: Emergency Preparedness (Sec.  491.12)

    Section 491.12(a) will require Rural Health Clinics (RHCs) and 
Federally Qualified Health Centers (FQHCs) to develop and maintain 
emergency preparedness plans. The RHCs and FQHCs will also have to 
review and update their plans at least annually. We proposed that the 
plan must meet the requirements listed at Sec.  491.12(a)(1) through 
(4).
    Section 491.12(a)(1) will require RHCs/FQHCs to develop a 
documented, facility-based and community-based risk assessment 
utilizing an all-hazards approach. RHCs/FQHCs will need to identify the 
medical and non-medical emergency events they could experience both at 
their facilities and in the surrounding area. RHCs/FQHCs will 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 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 11,500 RHC/FQHCs (4,200 RHCs + 7,300 FQHCs). Unlike RHCs, 
FQHCs are grantees and look-alikes under HRSA's Health Center Program. 
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 health centers 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 final rule. While the expectations set forth by HRSA in the 
Emergency Management PIN are not requirements for receiving a HRSA 
Center Program grant (and as such are not requirements for FQHCs), if 
HRSA finds that an FQHC is not meeting the expectations of the 
Emergency Management PIN, it would provide the FQHC with resources for 
technical assistance to assist them in meeting these expectations. This 
demonstrates the importance of the FQHC's compliance with the Emergency 
Management PIN guidance. 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 7,300 FQHCs 
separately from the 4,200 RHCs where the burden will be significantly 
different.
    Based on our experience with RHCs, we expect that all 4,200 RHCs 
have already performed at least some of the work needed to conduct a 
risk assessment. It is standard practice for healthcare 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)).
    Furthermore, 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 will 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 
requirements. For example, the expectations for FQHCs do not 
specifically address our requirement to address likely medical and non-
medical emergencies. In addition, participation in a community-based 
risk assessment is only encouraged, not required. We expect that all 
4,200 RHCs and 6,502 FQHCs will need to compare their current risk 
assessments with our requirements and accomplish the tasks necessary to 
ensure their risk assessments comply with our requirements. However, we 
expect that FQHCs will 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 healthcare 
facilities will include input from all of their major departments. 
Based on our experience with RHCs/FQHCs, we expect that conducting the 
risk assessment will 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 
will 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 will 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 will spend more time 
reviewing the risk assessment than the other individuals.
    We estimate that it will require 10 burden hours for each RHC to 
conduct a risk assessment that complied with the requirements in this 
section at a cost of $1,080. We estimate that for all RHCs to comply 
with our requirements will require 42,000 burden hours (10 burden hours 
for each RHC x 4,200 RHCs) at a cost of $4,536,000 ($1,080 estimated 
cost for each RHC x 4,200 RHCs).

                     Table 111--Total Estimated Cost for a RHC To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               4            $388
Medical Director/Physician......................................             181               2             362
Nurse Practitioner/Physician Assistant..........................              94               2             188

[[Page 63998]]

 
Registered Nurse................................................              71               2             142
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10           1,080
----------------------------------------------------------------------------------------------------------------

    We estimate that it will require 5 burden hours for each FQHC to 
conduct a risk assessment that complied with our requirements at a cost 
of $520. We estimate that for all 7,300 FQHCs to comply will require 
36,500 burden hours (5 burden hours for each FQHC x 7,300 FQHCs) at a 
cost of $3,796,000 ($520 estimated cost for each FQHC x 7,300 FQHCs). 
Based on those estimates, compliance with this requirement for all RHCs 
and FQHCs will require 78,500 burden hours at a cost of $8,332,000.

                    Table 112--Total Estimated Cost for an FQHC To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               2            $194
Medical Director/Physician......................................             181               1             181
Nurse Practitioner/Physician Assistant..........................              94               1              94
Registered Nurse................................................              51               1              51
                                                                 -----------------------------------------------
    Total.......................................................  ..............               5             520
----------------------------------------------------------------------------------------------------------------

    After conducting the risk assessment, RHCs/FQHCs will have to 
develop and maintain emergency preparedness plans that complied with 
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 final rule, all RHCs/FQHCs will have to review 
their current plans and compare them to their risk assessments. The 
RHCs/FQHCs will need to update, revise, and, in some cases, develop new 
sections to complete their emergency preparedness plans that meet our 
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 will need to 
comply under this final rule. However, we expect that FQHCs will need 
to compare their current EMP to our requirements and, if necessary, 
revise or develop new sections for their EMP to bring it into 
compliance. We expect that FQHCs will 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 will 
be involved in developing the emergency preparedness plans. However, we 
expect that it will require more time to complete the plans than the 
risk assessments. We expect that the administrator will have primary 
responsibility for reviewing and developing the RHC/FQHC's EMP. We 
expect that the physician, nurse practitioner or physician assistant, 
and registered nurse will review the draft plan and provide comments to 
the administrator. We estimate that for each RHC to comply with this 
requirement will require 14 burden hours at a cost of $1,379. 
Therefore, it will require an estimated 58,800 burden hours (14 burden 
hours for each RHC x 4,200 RHCs) to complete the plan at a cost of 
$5,791,800 ($1,379 estimated cost for each RHC x 4,200 RHCs).

               Table 113--Total Estimated Cost for a RHC To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               6            $582
Medical Director/Physician......................................             181               2             362
Nurse Practitioner/Physician Assistant..........................              94               3             282
Registered Nurse................................................              51               3             153
                                                                 -----------------------------------------------
    Total.......................................................  ..............              14           1,379
----------------------------------------------------------------------------------------------------------------

    We estimate that it will require 8 burden hours for each FQHC to 
comply with our requirements at a cost of $762. Based on that estimate, 
it will require 58,400 burden hours (8 burden hours for each FQHC x 
7,300 FQHCs) to complete

[[Page 63999]]

the plan at a cost of $5,562,600 ($762 estimated cost for each FQHC x 
7,300 FQHCs).

              Table 114--Total Estimated Cost for a FQHC To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               3            $291
Medical Director/Physician......................................             181               1             181
Nurse Practitioner/Physician Assistant..........................              94               2             188
Registered Nurse................................................              51               2             102
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8             762
----------------------------------------------------------------------------------------------------------------

    Based on the previous estimates, for all RHCs and FQHCs to develop 
an emergency preparedness plan that complies with our requirements will 
require 117,200 burden hours at a cost of $11,354,400.
    Each RHC/FQHC also will 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, we believe compliance with this requirement will constitute a 
usual and customary business practice for RHCs and FQHCs and will not 
be subject to the PRA in accordance with the implementing regulations 
of the PRA at 5 CFR 1320.3(b)(2).
    Section 491.12(b) will 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 will also require RHCs/
FQHCs to review and update these policies and procedures at least 
annually. At a minimum, we will 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 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 will 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 requirements.
    We expect that FQHCs already have policies and procedures that will 
comply with some of our requirements. Several of the expectations of 
the Emergency Management PIN address specific elements in 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 
will be less than the burden for RHCs.
    The burden associated with our requirements will be reviewing, 
revising, and, if needed, developing new emergency preparedness 
policies and procedures. We expect that a physician and a nurse 
practitioner will primarily be involved with these tasks and that an 
administrator will assist them. We estimate that for each RHC to comply 
with our requirements will require 12 burden hours at a cost of $1,482. 
Based on that estimate, for all 4,200 RHCs to comply with these 
requirements will require 50,400 burden hours (12 burden hours for each 
RHC x 4,200 RHCs) at a cost of $6,224,400 ($1,482 estimated cost for 
each RHC x 4,200 RHCs).

                  Table 115--Total Estimated Cost for a RHC To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               2            $194
Medical Director/Physician......................................             181               4             724
Nurse Practitioner/Physician Assistant..........................              94               6             564
                                                                 -----------------------------------------------
    Total.......................................................  ..............              12           1,482
----------------------------------------------------------------------------------------------------------------

    As discussed earlier, we expect that FQHCs will 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 
requirements will require 8 burden hours at a cost of $932. Based on 
that estimate, for all 7,300 FQHCs to comply with these requirements 
will require 58,400 burden hours (8 burden hours for each FQHC x 7,300 
FQHCs) at a cost of $6,803,600 ($932 estimated cost for each FQHC x 
7,300 FQHCs).

[[Page 64000]]



                  Table 116--Total Estimated Cost for a FQHC To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               2            $194
Medical Director/Physician......................................             181               2             362
Nurse Practitioner/Physician Assistant..........................              94               4             376
                                                                 -----------------------------------------------
    Total.......................................................  ..............               8             932
----------------------------------------------------------------------------------------------------------------

    Based on the previous estimates, for all RHCs and FQHCs to develop 
emergency preparedness policies and procedures that comply with our 
requirements will require 108,800 burden hours at a cost of 
$13,028,000.
    We proposed 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, we believe compliance with this 
requirement will constitute a usual and customary business practice for 
RHCs/FQHCs and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 491.12(c) will require RHCs/FQHCs to develop and maintain 
an emergency preparedness communication plan that complied with both 
federal and state law. RHCs/FQHCs will also have to review and update 
these plans at least annually. We proposed 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 healthcare 
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 healthcare 
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 will 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 proposed.
    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 will 
have a formal communication plan for emergencies and that those plans 
will contain some of our requirements. However, we expect that all 
FQHCs will 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 will 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 will 
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 will 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 requirements will 
require 10 burden hours at a cost of $1,126. Based on that estimate, 
for all 4,200 RHCs to comply will require 42,000 burden hours (10 
burden hours for each RHC x 4,200 RHCs) at a cost of $4,729,200 ($1,126 
estimated cost for each RHC x 4,200 RHCs).

                    Table 117--Total Estimated Cost for a RHC To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               4            $388
Medical Director/Physician......................................             181               2             362
Nurse Practitioner/Physician Assistant..........................              94               4             376
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10           1,126
----------------------------------------------------------------------------------------------------------------

    We estimate that for a FQHC to comply with the requirements will 
require 5 burden hours at a cost of $563. Based on this estimate, for 
all 7,300 FQHCs to comply will require 36,500 burden hours (5 burden 
hours for each FQHC x 7,300 FQHCs) at a cost of $4,109,900 ($563 
estimated cost for each FQHC x 7,300 FQHCs).

[[Page 64001]]



                   Table 118--Total Estimated Cost for a FQHC To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               2            $194
Medical Director/Physician......................................             181               1             181
Nurse Practitioner/Physician Assistant..........................              94               2             188
                                                                 -----------------------------------------------
    Total.......................................................  ..............               5             563
----------------------------------------------------------------------------------------------------------------

    We proposed 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, we believe compliance with this requirement 
will constitute a usual and customary business practice for RHCs/FQHCs 
and will not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 491.12(d) will require RHCs/FQHCs to develop and maintain 
emergency preparedness training and testing programs and review and 
update these programs at least annually. We proposed that an RHC/FQHC 
will have to comply with the requirements listed in Sec.  491.12(d)(1) 
and (2).
    Section 491.12(d)(1) will 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 will also 
have to ensure that its staff could demonstrate knowledge of those 
emergency procedures. Thereafter, each RHC and FQHC will be required to 
provide emergency preparedness training annually.
    Based on our experience with RHCs and FQHCs, we expect that all 
11,500 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 will 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 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 will likely be an administrator. We expect 
that the administrator will 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 requirements; and making 
changes to current training materials and developing new training 
materials. We expect that the administrator will work with a registered 
nurse to develop the revised and updated training program. We estimate 
that it will require 10 burden hours for each RHC or FQHC to develop a 
comprehensive emergency training program at a cost of $602. Therefore, 
it will require an estimated 115,500 burden hours (10 burden hours for 
each RHC/FQHC x 11,500 RHCs/FQHCs) to comply with this requirement at a 
cost of $6,923,000 ($602 estimated cost for each RHC/FQHC x 11,500 
RHCs/FQHCs).

                  Table 119--Total Estimated Cost for a RHC/FQHC To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               2            $194
Nurse Practitioner/Physician Assistant..........................              51               8             408
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10             602
----------------------------------------------------------------------------------------------------------------

    Section 491.12(d) will also require that RHCs/FQHCs develop and 
maintain emergency preparedness training and testing programs that will 
be reviewed and updated at least annually. We believe that RHCs/FQHCs 
already review their emergency preparedness programs periodically. 
Therefore, we believe compliance with this requirement will constitute 
a usual and customary business practice for RHCs/FQHCs and will not be 
subject to the PRA in accordance with the implementing regulations of 
the PRA at 5 CFR 1320.3(b)(2).
    Section 491.12(d)(2) will require RHCs/FQHCs to participate in a 
full-scale exercise at least annually. They will also be required to 
participate in an additional testing exercise of their choice at least 
annually. RHCs/FQHCs will 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 will be exempt from the 
requirement for a community or individual, facility-based full-scale 
exercise 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 will have to comply with all of these 
requirements.
    The burden associated with complying with these requirements will 
be the resources the RHC or FQHC will

[[Page 64002]]

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 
11,500 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 the testing exercises 
and emergency events or that they conduct both two testing exercises 
annually. Thus, we will analyze the burden associated with these 
requirements for all 11,500 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 will develop the scenarios for the drills and 
exercises and the accompanying documentation. We expect that the 
administrator and a registered nurse will be primarily involved in 
accomplishing these tasks. We estimate that for each RHC/FQHC to comply 
with the requirements in this section will require 5 burden hours at a 
cost of $347. Based on this estimate, for all 11,500 RHCs/FQHCs to 
comply with the requirements in this section will require 57,500 burden 
hours (5 burden hours for each RHC/FQHC x 11,500 RHCs/FQHCs) at a cost 
of $3,990,500 ($347 estimated cost for each RHC/FQHC x 11,500 RHC/
FQHCs).

                        Table 120--Total Estimated Cost for a RHC/FQHC To Conduct Testing
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................             $97               2            $194
Nurse Practitioner/Physician Assistant..........................              51               3             153
                                                                 -----------------------------------------------
    Total.......................................................  ..............               5             347
----------------------------------------------------------------------------------------------------------------


Table 121--Burden Hours and Cost Estimates for all 11,500 RHC/FQHCS To Comply With the ICRs Contained in Sec.   491.12 Condition: Emergency Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                                                         Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      Respondents   Responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   491.12(a)(1) (RHCs).........  0938-New..............         4,200        4,200           10       42,000           **     4,536,000    4,536,000
Sec.   491.12(a)(1) (FQHCs)........  0938-New..............         7,300        7,300            5       36,500           **     3,796,000    3,796,000
Sec.   491.12(a)(1)-(4) (RHCs).....  0938-New..............         4,200        4,200           14       58,800           **     5,791,800    5,791,800
Sec.   491(a)(1)-(4) (FQHCs).......  0938-New..............         7,300        7,300            8       58,400           **     5,562,600    5,562,600
Sec.   491.12(b) (RHCs)............  0938-New..............         4,200        4,200           12       50,400           **     6,224,400    6,224,400
Sec.   491.12(b) (FQHCs)...........  0938-New..............         7,300        7,300            8       58,400           **     6,803,600    6,803,600
Sec.   491.12(c) (RHCs)............  0938-New..............         4,200        4,200           10       42,000           **     4,729,200    4,729,200
Sec.   491.12(c) (FQHCs)...........  0938-New..............         7,300        7,300            5       36,500           **     4,109,900    4,109,900
Sec.   491.12(d)(1)................  0938-New..............        11,500       11,500           10      115,000           **     6,923,000    6,923,000
Sec.   491.12(d)(2)................  0938-New..............        11,500       11,500            5       57,500           **     3,990,500    3,990,500
                                                            --------------------------------------------------------------------------------------------
    Totals.........................  ......................        11,500       11,500  ...........      555,500  ............  ...........   52,467,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 121.

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

    Section 494.62(a) will require dialysis facilities to develop and 
maintain emergency preparedness plans that will have to reviewed and 
updated at least annually. Section 494.62 will require that the plan 
include the elements set out at Sec.  494.62(a)(1) through (4).
    Section 494.62(a)(1) will 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 will 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 will 
need to identify the measures it will need to take to ensure the 
continuity of its operations, including delegations of authority and 
succession plans.
    The burden associated with this requirement will 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 will 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 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 will 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

[[Page 64003]]

risk assessment will require the involvement of the dialysis facility's 
chief executive officer or administrator, medical director, nurse 
manager, social worker, and a patient care technician (PCT). We believe 
that all of these individuals will 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 will 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 
will 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 will require 12 burden hours at a 
cost of $1,206. There are currently 6,648 dialysis facilities. 
Therefore, it will require an estimated 79,776 burden hours (12 burden 
hours for each dialysis facility x 6,648 dialysis facilities) for all 
dialysis facilities to comply with this requirement at a cost of 
$8,017,488 ($1,206 estimated cost for each dialysis facility x 6,648 
dialysis facilities).

               Table 122--Total Cost Estimate for a Dialysis Facility To Conduct a Risk Assessment
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $106               4            $424
Medical Director/Physician......................................             207               2             414
Nurse Manager...................................................              94               2             188
Social Worker...................................................              51               2             102
Patient Care Dialysis Technician................................              39               2              78
                                                                 -----------------------------------------------
    Total.......................................................  ..............              12           1,206
----------------------------------------------------------------------------------------------------------------

    After conducting the risk assessment, each dialysis facility will 
then have to develop and maintain an emergency preparedness plan that 
the facility must evaluate and update at least annually. This emergency 
plan will have to comply with the requirements at 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 to 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 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 will 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 will have to review their current plans and 
compare them to the risk assessment they performed according to Sec.  
494.62(a)(1). The dialysis facility will 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 section. The 
plan will also address how the dialysis facility will continue 
providing its essential services, which are the services that the 
dialysis facility will continue to provide despite an emergency. The 
dialysis facility will 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 will 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 will 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 will 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 will 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 will 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 will 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 will be involved in the development of the 
emergency preparedness plan. This is less time than we estimate it will 
take for the risk assessment because dialysis facilities are currently 
required to have an emergency plan (Sec.  494.60(d)(4)). Based on this 
final rule, the dialysis facility will need to update, revise, and, in 
some cases, develop new sections to complete an emergency preparedness 
plan that addresses the risks identified in their risk assessment and 
the specific requirements contained in this regulation.
    We estimate that complying with this requirement will require 10 
burden hours at a cost of $1,116 for each dialysis facility. There are 
6,648 dialysis facilities. Therefore, it will require an estimated 
66,480 burden hours (10 burden hours for each dialysis facility x 6,648 
dialysis facilities) to complete the plan at a cost of $7,419,168 
($1,116

[[Page 64004]]

estimated cost for each dialysis facility x 6,648 dialysis facilities).

        Table 123--Total Cost Estimate for a Dialysis Facility To Develop an Emergency Preparedness Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $106               4            $424
Medical Director/Physician......................................             207               2             414
Nurse Manager...................................................              94               2             188
Social Worker...................................................              51               1              51
Patient Care Dialysis Technician................................              39               1              39
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10           1,116
----------------------------------------------------------------------------------------------------------------

    Each dialysis facility will 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, we believe 
compliance with this requirement will constitute a usual and customary 
business practice and will not be subject to the PRA in accordance with 
the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 494.62(b) will 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 will include, but will 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 will 
also have to review and update these policies and procedures at least 
annually. The policies and procedures will 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 Sec.  
494.60(d) already require dialysis facilities to 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 will 
satisfy some of the requirements in this section. For example, each 
dialysis facility is already required at Sec.  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 will 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 will be the time and effort necessary to comply 
with these requirements. We expect the administrator, medical director, 
and the nurse manager will be primarily involved with reviewing, 
revising, and if needed, developing any new policies and procedures 
that were needed. The remaining individuals will likely review the 
sections of the policies and procedures that directly affect their 
areas of expertise. Therefore, we estimate that complying with this 
requirement will require 10 burden hours at a cost of $1,116 for each 
dialysis facility. There are 6,648 dialysis facilities. Therefore, it 
will require an estimated 66,480 burden hours (10 burden hours for each 
dialysis facility x 6,648 dialysis facilities) to complete the plan at 
a cost of $7,419,168 ($1,116 estimated cost for each dialysis facility 
x 6,648 dialysis facilities).

            Table 124--Total Cost Estimate for a Dialysis Facility To Develop Policies and Procedures
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $106               4            $424
Medical Director/Physician......................................             207               2             414
Nurse Manager...................................................              94               2             188
Social Worker...................................................              51               1              51
Patient Care Dialysis Technician................................              39               1              39
                                                                 -----------------------------------------------
    Total.......................................................  ..............              10           1,116
----------------------------------------------------------------------------------------------------------------

    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, we believe compliance with this requirement will 
constitute a usual and customary business practice for dialysis 
facilities and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 494.62(c) will 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

[[Page 64005]]

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 will be an 
integral part of any emergency preparedness plan. Current CfCs already 
require dialysis facilities to have a written disaster plan (42 CFR 
494.60(d)(4)). Thus, each dialysis facility should already have some of 
the contact information they will 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 healthcare 
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 will 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 will 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 will 
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 will require 
4 burden hours at a cost of $513. Therefore, for all of the dialysis 
facilities to comply with this requirement will require an estimated 
26,592 burden hours (4 burden hours for each dialysis facility x 6,648 
dialysis facilities) at a cost of $3,410,424 ($513 estimated cost for 
each dialysis facility x 6,648 dialysis facilities).

             Table 125--Total Cost Estimate for a Dialysis Facility To Develop a Communication Plan
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $106               2            $212
Medical Director/Physician......................................             207               1             207
Nurse Manager...................................................              94               1              94
                                                                 -----------------------------------------------
    Total.......................................................  ..............               4             513
----------------------------------------------------------------------------------------------------------------

    Each dialysis facility will 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 will expect 
that dialysis facilities will review their emergency preparedness 
communication plans annually. We believe that all dialysis facilities 
have an administrator that will be primarily responsible for the day-
to-day operation of the dialysis facility. This will 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 will 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 will constitute a usual and customary business 
practice and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 494.62(d) will require dialysis facilities to develop and 
maintain emergency preparedness training, testing and patient 
orientation programs that will have to be evaluated and updated at 
least annually. The dialysis facility will have to comply with the 
requirements located at Sec.  494.62(d)(1) through (3).
    Section 494.62(d)(1) will 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 will 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 (Sec.  
494.60(d)(1)) and provide appropriate orientation and training to 
patients in emergency preparedness (Sec.  494.60(d)(2)). In addition, 
the dialysis facility's patient instruction will 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 will 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 
in accordance with Sec.  494.62(a) through (c). Dialysis facilities 
will 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 will be 
the time and effort necessary to develop the required training program. 
We expect that complying with this requirement will 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 (Sec.  494.150(b)). We 
estimate that it will require 7 burden hours for each dialysis facility 
to develop an emergency training program at a cost of $807. Therefore, 
it will require an estimated 46,536 burden hours (7 burden hours for 
each dialysis facility x 6,648 dialysis facilities) to comply with this 
requirement at a cost of $5,364,936 ($807 estimated cost for each 
dialysis facility x 6,648 dialysis facilities).

[[Page 64006]]



              Table 126--Total Cost Estimate for a Dialysis Facility To Develop a Training Program
----------------------------------------------------------------------------------------------------------------
                            Position                                Hourly wage    Burden hours    Cost estimate
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $106               3            $318
Medical Director/Physician......................................             207               1             207
Nurse Manager...................................................              94               3             282
                                                                 -----------------------------------------------
    Total.......................................................  ..............               7             807
----------------------------------------------------------------------------------------------------------------

    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, we believe compliance with 
this requirement will constitute a usual and customary business 
practice and will not be subject to the PRA in accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 494.62(d)(2) requires dialysis facilities to participate in 
a full scale exercise at least annually. They will also be required to 
conduct one additional exercise of their choice 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 will be exempt from engaging in a full-scale exercise 
for 1 year following the onset of the actual event. Dialysis facilities 
will 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 will need to develop 
scenarios for each drill and exercise. A dialysis facility will 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, we believe complying with this 
requirement will constitute a usual and customary business practice and 
will not be subject to the PRA in accordance with the implementing 
regulations of the PRA at 5 CFR 1320.3(b)(2).
    Section 494.62(d)(3) will require dialysis facilities to provide 
appropriate orientation and training to patients, including the areas 
specified in Sec.  494.62(d)(1). Section 494.62(d)(1) specifically will 
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 will already be included 
in the burden estimate for Sec.  494.62(d)(1).

  Table 127--Burden Hours and Cost Estimates for All 6,648 Dialysis Facilities To Comply With The ICRs Contained in Sec.   494.62 Condition: Emergency
                                                                      Preparedness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Total     Hourly labor  Total labor
                                                                                         Burden per     annual       cost of      cost of     Total cost
       Regulation section(s)            OMB  Control No.      Respondents   Responses     response      burden      reporting    reporting       ($)
                                                                                          (hours)      (hours)         ($)          ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   494.62(a)(1)................  0938-New..............         6,648        6,648           12       79,776           **     8,017,488    8,017,488
Sec.   494.62(a)(2)-(4)............  0938-New..............         6,648        6,648           10       66,480           **     7,419,168    7,419,168
Sec.   494.62(b)...................  0938-New..............         6,648        6,648           10       66,480           **     7,419,168    7,419,168
Sec.   494.62(c)...................  0938-New..............         6,648        6,648            4       26,592           **     3,410,424    3,410,424
Sec.   494.62(d)...................  0938-New..............         6,648        6,648            7       46,536           **     5,364,936    5,364,936
                                                            --------------------------------------------------------------------------------------------
    Totals.........................  ......................         6,648       33,240  ...........      285,864  ............  ...........   31,631,184
--------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor cost is blended between the wages for multiple staffing levels.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 127.

T. Summary of Information Collection Burden

    Based on the previous analysis, the burden for complying with all 
of the requirements in this final rule will be 3,089,505 burden hours 
at a cost of $279,680,069. Table 127 provides a summary of the ICR 
burden, for the hours and the costs, for each element of the 
requirements in this final rule for each provider and supplier type.

[[Page 64007]]

[GRAPHIC] [TIFF OMITTED] TR16SE16.000


[[Page 64008]]


    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-F), 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-F, 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 requires the Department of Homeland Security 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 final 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 will be $373 million in the first 
year, and the subsequent projected annual cost will be approximately 
$25 million. We solicited and received comments on the proposed RIA. As 
such, we have presented our best estimate of the impact, including both 
costs and benefits, of this rule.
1. Disaster Data
    Published reports after Hurricane Katrina reported that the 
Louisiana Attorney General investigated approximately 215 deaths that 
occurred in hospitals and nursing homes following Katrina. (Fink, Sheri 
(September 10, 2013). Five Days at Memorial: Life and Death in a Storm-
Ravaged Hospital. New York: Crown Publishers. p. 360. ISBN 978-0-307-
71896-9.) Since nearly all hospitals and nursing homes are certified to 
participate in the Medicare program, we estimate that at least a small 
percentage of these lives could be saved as a result of emergency 
preparedness measures in a single disaster of equal magnitude. Katrina 
is an extreme example of a natural disaster, so we also considered 
other more common disasters. The United 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).
2. Benefits to Patients/Residents
    It is commonly understood that healthcare facilities that do not 
have an emergency plan, develop policies and procedures, and train and 
exercise their staff are at a heightened risk for healthcare delivery 
and service disruptions. For instance, patients with ESRD have 
experienced problems accessing care and adverse outcomes during 
disasters. These patients are particularly at risk for having increased 
morbidity and mortality following disasters due to their dependence on 
regular life-maintaining dialysis treatments. Hurricane Katrina was 
particularly devastating for the dialysis-dependent population and led 
to the dialysis community, including facilities, recommending more 
integrated and better emergency planning, training and exercises in 
addition to other preparedness recommendations. One example was for 
dialysis facilities to implement early dialysis (an early treatment in 
advance of the storm's landfall) for notice weather events, such as 
hurricanes, snow storms, or other severe weather (Kenney, Robert J. 
``Emergency preparedness concepts for dialysis facilities: Reawakened 
after Hurricane Katrina.'' Clinical Journal of the American Society of 
Nephrology 2.4 (2007): 809-813 DOI: 10.2215/CJN.03971106). In order to 
implement early dialysis, particularly in moderate to large scale 
emergencies, facilities need to have an integrated emergency plan, 
policies and procedures, training and exercises. All of which are 
needed to better ensure that staff are able to rapidly activate and 
operate the facility emergency plan, prioritize and contact patients 
and transportation, and coordinate a surge in patient care coordination 
for both early and their regularly scheduled dialysis treatments.
    Hurricane Sandy was predicted to be a severe storm many days in 
advance of its actual landfall. State health officials, in anticipation 
of its severity, encouraged dialysis facilities to dialyze patients 
ahead of schedule and rapidly activated the Kidney Community

[[Page 64009]]

Emergency Response (KCER) Coalition to provide additional assistance 
for coordinating notification and transportation services for patients, 
and to activate additional staff and resources to provide treatment at 
numerous facilities. Studies, following Hurricane Sandy, found regional 
variability in the receipt of early dialysis amongst the nearly 14,000 
dialysis study patients. ASPR and CMS, using Medicare claims data, 
conducted the two studies to assess the impact of Hurricane Sandy on 
end-stage renal disease patients that require regular dialysis and to 
assess early dialysis treatment patterns and outcomes for those 
receiving it in the impacted areas. The first study identified a 
significant increase in the number of emergency department visits, 
hospitalizations, and patient death 30 days following the disaster and 
regional variability in patients receiving early dialysis prior to 
Hurricane Sandy's landfall. The second study found that the 60 percent 
of study patients that received early dialysis were found to have 20 
percent lower odds of having an emergency department visit, 21 percent 
lower odds of a hospitalization in the week of the storm, and 28 
percent lower odds of death 30 days after the storm. (Kelman J., Finne 
K., Bogdanov A., Worrall C., Margolis G., Rising K., MaCurdy T.E., 
Lurie N. Dialysis care and death following Hurricane Sandy. Am J Kidney 
Dis. 2015 Jan; 65(1):109-15. doi: 10.1053/j.ajkd.2014.07.005. Epub 2014 
Aug 22. PubMed PMID: 25156306. and Lurie, N., Finne, K., Worrall, C., 
Jauregui, M., Thaweethai, T., Margolis, G., & Kelman, J. (2015). Early 
dialysis and adverse outcomes after Hurricane Sandy. Am J Kidney Dis., 
66(3), 507-512.
    Although we are unable to specifically quantify the number of lives 
saved as a result of this final rule, all of the data we have reviewed 
regarding emergency preparedness indicate that implementing the 
requirements in this final 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. The 
following cost analysis is based on ``Guidelines for Regulatory Impact 
Analysis'' (Robinson, L.A. and J.K. Hammitt. 2015, ``Valuing Reductions 
in Risks of Fatal Illness: Implications of Recent Research.'' Health 
Economics. 25(8): 1039-1052) developed by Harvard University for the 
Assistant Secretary for Planning and Evaluation (ASPE). The Guidelines 
are not yet public, however based on the research that was published in 
Health Economics, we have provided the following cost analysis. In 
order to ``break even'' on the cost of this rule, that is, in order for 
the total costs of implementing this rule to equal the total benefits 
of doing so- this rule would need to save 11.5 lives per year for 5 
years at a 7 percent discount rate and a value of $9 million per 
statistical life saved. It would take about 11 statistical lives saved 
per year for 5 years at a 3 percent discount rate for this final rule 
to break even. Therefore, 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.
    We believe that this final rule will 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 final rule will establish a regulatory framework with which 
Medicare- and Medicaid-participating providers and suppliers will have 
to comply to ensure that the varied providers and suppliers of 
healthcare are adequately prepared to respond to natural and man-made 
disasters.
3. The Regulatory Flexibility Act (RFA)
    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 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 
$11 million to $38.5 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 final 
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 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 604 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 final 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.
4. Unfunded Mandates Reform Act
    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 2016, that threshold level is 
approximately $146 million. This omnibus final rule contains mandates 
that will impose a one-time cost of approximately $373 million. Thus, 
we have assessed the various costs and benefits of this final rule. It 
is clear that a number of providers and suppliers will be affected by 
the implementation of this final rule and that a substantial number of 
those entities will be required to make changes in their operations. 
This final rule will 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.
5. Federalism
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it develops a final 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 final rule will not impose substantial direct 
requirement costs on state or local governments,

[[Page 64010]]

preempt state law, or otherwise implicate federalism.
6. Congressional Review Act
    This final rule 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 final rule will 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 will differ between 
hospitals and the various other providers and suppliers, depending upon 
a variety of factors, including existing regulatory requirements and 
accreditation standards.
    We discuss the economic impact for each provider and supplier type 
included in this final rule in the order in which they appear in the 
CFR. Most of the economic impact of this final rule will 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 final 
rule. We provide a chart at the end of the RIA section of the total 
regulatory impact for each provider or supplier.
    As stated in the ICR section of this final rule, we obtained all 
salary information from the May 2014 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 100 percent for overhead and fringe benefits.
1. Subsistence Requirement
    This final rule will 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.
    Furthermore, 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 will last for a longer duration, other may not. Thus, we 
believe that to require such stockpiling will create an unnecessary 
economic impact on some healthcare providers.
    We expect that when inpatient providers determine their supply 
needs, they will 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
    We proposed to 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 2012 edition 
of the Life Safety Code (LSC) of the NFPA[supreg] 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[supreg] 99 and NFPA[supreg] 110 and 
NFPA[supreg] 101, we proposed 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. We received the following public 
comment(s) on this requirement:
    Comment: We received a large number of comments from individual 
hospitals as well as national and state organizations that expressed 
concern with the proposed requirement for hospitals, CAHs and LTC 
facilities to test their generators. Several commenters stated that 
there was not enough empirical data to support the proposed additional 
financial burden. Furthermore, they stated that there is no evidence 
that additional annual testing would result in more reliable generators 
and that their current testing schedule is sufficient. Several 
commenters stated that mandating additional testing would further 
burden already strained budgets and that the additional testing would 
cause unnecessary wear and tear on the equipment.
    Response: We appreciate the commenters concerns on this issue. As 
we discussed previously in the preamble of this final rule, the purpose 
of the proposed change in the testing requirement was to minimize the 
issue of inoperative equipment in the event of a major disaster, such 
as what happened during the Sandy Super Storm. After carefully 
reviewing subsequent reports on the Sandy Super Storm (for example, the 
September, 2014 report of the Office of Inspector General (OIG) 
entitled, ``Hospital Emergency Preparedness and Response During Super 
Storm Sandy; and the American Society for Healthcare Engineering 
(ASHE)), and the comments received on the proposed requirement, we 
believe that we do not have sufficient data to make the assumption that 
additional testing would ensure that the generators would withstand all 
disasters, regardless of the amount of testing conducted prior to an 
actual disaster. Therefore, we have decided against finalizing the 
proposed requirement for additional generator testing at this time. We 
expect facilities that have generators to continue to test their 
equipment based on current NFPA[supreg] codes (NFPA[supreg] 99 and 
NFPA[supreg] 110 and NFPA[supreg] 101) and manufacturer requirements.
3. Purchase of Communication Devices
    We are finalizing our proposal to require providers and suppliers 
to develop and maintain a communication plan that includes the contact 
information for and a means for communicating with staff, federal, 
state,

[[Page 64011]]

tribal, regional, and local emergency management entities. It is 
crucial for providers and suppliers to be aware of who to contact 
during an emergency situation and for them to have a means for 
communicating with the appropriate emergency management officials 
during an emergency or disaster. While we did not propose a specific 
mechanism for purposes of communicating during an emergency, we 
recognize the possibility that some providers and suppliers may need to 
purchase communication devices to meet the requirements of this final 
rule.
    We anticipate that most providers and suppliers maintain updated 
information for staff as well as state and local officials as part of 
their typical business operations. We also expect that as a best 
practice, many providers and suppliers already utilize some type of 
communication system or device for purposes of communicating with their 
staff, physicians, volunteers, and other providers and suppliers during 
emergency situations. We want to reiterate that in addition to cellular 
phones, alternate communication devices may also include but are not 
limited to pagers, radio transceivers, various radio devices such as 
the National Oceanic and Atmospheric Administration's Weather Radio All 
Hazards, and Portable interconnected Voice over Internet Protocol 
(VoIP) services.
    For purposes of the RIA, we assume that, at a minimum, those 
providers and suppliers without existing emergency preparedness 
requirements are mostly likely to be presented with the need to 
purchase communication devices to comply with the requirements of the 
communication plan in this final rule. Those provider and supplier 
types without any existing emergency preparedness requirements are 
CMHCs, OPOs, PRTFs, and outpatient hospices. As stated previously, this 
final rule will impact 17 different provider and supplier types. When 
taking into consideration all 17 provider and supplier types, this rule 
will have a combined impact on 72,315 entities (sum of the total number 
of provider and supplier entities). Those providers and supplier types 
without emergency preparedness requirements represent 6 percent of this 
total (4,622 total entities without existing emergency preparedness 
related requirements (198 CMHCs + 58 OPOs + 377 PRTFs + 3,989 
outpatient hospices)/72,315 (sum of the total number of entities 
impacted by this regulation)). Therefore, we anticipate that, at a 
minimum 6 percent of the providers and suppliers impacted by this final 
rule will have the potential need to purchase communication devices to 
comply with the requirements of the final rule.
4. Use of Outside Consultants
    We recognize that some of the provider and supplier types impacted 
by this final rule have more experience in the area of emergency 
preparedness than others. In particular, those provider and supplier 
types without existing emergency preparedness related requirements may 
find it useful to seek resources and guidance from outside consultants 
for purposes of complying with the requirements of this final rule. We 
note that we have not required providers and suppliers to hire outside 
consultants to develop their emergency preparedness programs, and we do 
not believe it will be necessary in most cases based on the free 
resources and information available to providers. Furthermore, in 
advance of hiring outside consultants, we encourage providers and 
suppliers to look to their local public health, emergency management 
agencies and local healthcare coalitions for assistance and guidance. 
Therefore, for purposes of the RIA we have not included a cost 
associated with the activity of hiring outside consultants, as we are 
unable to quantify with any degree of certainty the number of providers 
that may choose to use outside resources or the cost of such resources.
    There are nearly 500 healthcare coalitions nationwide that 
providers and suppliers may seek to participate in, which currently 
include more than 24,000 healthcare facilities and community partners. 
In addition, providers and suppliers should leverage resources through 
their memberships with professional associations and non-government 
agencies, such as the Red Cross. Many non-government organizations and 
both national and local professional associations provide vetted 
emergency preparedness resources, materials and trainings. These 
organizations and healthcare coalitions also commonly conduct and 
support community-based exercises and encourage participation from 
other providers in their localities.
    In addition, we note that there are several readily accessible, 
free, and expert-vetted, emergency preparedness resources that are 
available to providers and suppliers from government entities. First, 
providers and suppliers may access HHS' Office of the Assistant 
Secretary for Preparedness and Response (ASPR) Technical Resources 
Assistance Center Information Exchange (TRACIE) found at https://asprtracie.hhs.gov/. TRACIE can be used to locate sample plans, tools, 
templates, and training and exercise materials. TRACIE also provides 
access to expert technical assistance and an information-sharing 
exchange platform to assist the exchange of best practices, vetted 
tools, and information between public health, healthcare professionals, 
and many other emergency preparedness partners. TRACIE's technical 
assistance specialists can be reached Monday through Friday, 9 a.m. to 
5 p.m. Eastern Standard Time, at 1-844-5-TRACIE or by email at 
[email protected].
    Providers and suppliers may also access the Centers for Disease 
Control and Prevention (CDC) Web site found at http://www.cdc.gov/phpr/healthcare/planning.html) for various tools and resources. In addition, 
there are many tools and free online training sessions related to 
emergency preparedness that are offered through FEMA's Emergency 
Management Institute (EMI) Web site found at https://training.fema.gov/emi.aspx.
    Lastly, while we recognize that some providers may choose to seek 
some outside consulting assistance, we note that it is important that 
providers and suppliers develop their own plans to ensure that they 
truly understand their capabilities and can readily activate and 
implement their emergency and communication plans in the event of an 
emergency. Additional resources that can support provider and supplier 
preparedness are below:
     HHS Response and Recovery Resources Compendium (http://www.phe.gov/emergency/hhscapabilities/Pages/default.aspx): HHS Response 
and Recovery Resources Compendium offers an easy-to-navigate, 
comprehensive, web-based repository of HHS resources and capabilities 
available to federal, state, tribal, territorial, and local agencies 
before, during, and after public health and medical incidents. The 
compendium spans 24 topics, including situational awareness and mass 
care and emergency assistance, and contains a list of the major HHS 
capabilities, products and services that support that each topic and 
information on accessing them.
     DisasterLit (https://disasterlit.nlm.nih.gov/): 
DisasterLit is a database of disaster medicine and public health 
resources selected from over 700 organizations available at no cost. 
These resources include guidelines, government and other technical 
documents, plans, videos, and training classes.
     Public Service Announcements for Disasters: Public Service 
Announcements (PSAs) provide a wide

[[Page 64012]]

variety of announcements on common issues in disaster preparedness, 
response and recovery. They can be used to help health communicators 
provide timely messages about what people can do to protect themselves, 
their families and their communities during disasters and emergencies. 
They are available in a wide variety of formats, including tweets, 
vines, podcasts, YouTube videos, broadcast scripts, and broadcast 
videos.

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 $30,240.
2. Testing (Sec.  403.748(d)(2))
    Section 403.748(d)(2) will require RNHCIs to conduct a paper-based, 
tabletop exercise at least annually. RNHCIs 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 will be 
limited to the staff time needed to participate in the tabletop 
exercises. We estimate that approximately 4 hours of staff time will 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 will be required to spend a 
minimal amount of time during these exercises and such staff time will 
be considered a part of regular on-going training for RNHCI staff. We 
estimate that it will require 10 hours of staff time for each of the 18 
RNHCIs to conduct exercises at a cost of $476. Therefore, it will 
require an estimated total impact of $8,568 each year after the initial 
year for all RNHCIs to comply with Sec.  403.748(d)(2). For the initial 
year, we estimate $38,808 as the total economic impact and cost 
estimates for all 18 RNHCIs to comply with the requirements in this 
final rule.

E. Condition for Coverage: Emergency Preparedness for Ambulatory 
Surgical Centers (ASCs)--Testing (Sec.  416.54(d)(2))

    Section 416.54(d)(2) will require ASCs to participate in a full-
scale exercise at least annually. ASCs also will be required to conduct 
one additional testing exercise of their choice at least annually. ASCs 
also will 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 will be 
limited to the staff time to participate in the community-wide and 
facility-wide trainings, and testing exercises. We believe that 
appreciable staff time will be required of the administrator and a 
registered nurse. We believe that other staff members will be required 
to spend a minimal amount of time during these exercises and the 
training will be considered as part of regular on-going training for 
ASC staff. We estimate that the administrator and a registered nurse 
will spend about 4 hours each on an annual basis to participate in the 
testing exercises. Thus, we anticipate that complying with this 
requirement will require 8 hours for an estimated cost of $724 for each 
of the 5,485 ASCs and a total cost estimate of $3,971,140 for all ASCs 
($724 x 5,485 ASCs) each year after the first year. We estimate total 
costs for ASCs of $22,366,315 ($3,971,140 impact cost + $18,395,175ICR 
burden) in the first year of compliance, and $3,971,140, per year in 
subsequent years.

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

    Section 418.113(d)(2)(i) through (iii) will require hospices to 
participate in testing exercises at least annually. We believe that the 
administrator will be responsible for participating in community-wide 
disaster drills and will be the primary person to organize any testing 
exercises with the assistance of one member of the IDG. We believe that 
the registered nurse will most likely represent the IDG during the 
testing exercises. While we expect that all staff will be involved in 
the testing exercises, we will consider their involvement as part of 
their regular staff training. However, for the purpose of this analysis 
we assume that the administrator will spend approximately 4 hours 
annually to participate in a full-scale exercise and one additional 
testing exercise of the facility's choice outside of their regular and 
ongoing training. We also assume that the registered nurse will spend 4 
hours to participate in the testing exercises. Thus, we estimate that 
each hospice will spend $560. The total estimate for all hospices to 
comply with this requirement after the initial year will total 
$2,464,560 ($560 x 4,401 hospices). We estimate the total economic 
impact and cost estimates for all 4,401 hospices to comply with the 
requirements in this final rule for the initial year will be 
$22,428,668 ($2,464,560 impact cost + $19,964,108 ICR burden).

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

    Section 441.184(d)(2)(i) through (iii) will require PRTFs to 
participate in a full-scale exercise and one additional exercise of 
their choice annually. We estimate that the cost associated with this 
requirement is the time that it will take key personnel to participate 
in the testing exercises. Furthermore, we estimate that the testing 
exercises will involve the administrator and registered nurse to spend 
about 4 hours each on an annual basis to participate. Thus, we 
anticipate that complying with this requirement will require 4 hours 
for the administrator (at a salary of $93 an hour) and 4 hours for the 
registered nurse (salary $64 an hour) at a combined estimated cost of 
$628 per facility. The total annual cost for all 377 PRTFs will be 
$236,756. The total cost for the first year to comply with the 
requirement will be $1,471,431 ($236,756 impact cost + $1,234,675 ICR 
burden).

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

    Section 460.84(d)(2)(i) through (iii) will require PACE 
organizations to conduct a full-scale exercise and one additional 
testing exercise of their choice annually. Since PACE organizations are 
currently required to conduct a facility-wide drill annually, we are 
only estimating economic impact

[[Page 64013]]

for the additional testing exercise. We expect that both the home-care 
coordinator and the quality-improvement nurse will each spend 1 hour to 
conduct the exercise. Thus, we estimate the economic impact hours to be 
2 hours for each PACE organization at an estimated cost of $128 for 
each organization. The total annual cost for all PACE organizations is 
$15,232 ($128 x 119 providers). The total cost for all PACE 
organizations to comply with the requirements in the first year will be 
$645,904 ($15,323 impact cost + $630,581 ICR burden).

I. Condition of Participation: Emergency Preparedness for Hospitals

1. Medical Supplies (Sec.  482.15(b)(1))
    We proposed that hospitals must maintain medical supplies. This 
regulation does not require sufficient supplies for a certain time 
frame, but other organizations do suggest standards. The American 
Hospital Association (AHA) recommends that individual hospitals have a 
24-hour supply of pharmaceuticals and that they develop a list of 
required medical and surgical equipment and supplies. TJC standards 
require a hospital to have a 48 to 72 hour stockpile of medication and 
supplies.
    The Department of Homeland Security (DHS) Act of 2002 established 
the Strategic National Stockpile (SNS) Program to work with 
governmental and non-governmental partners to upgrade the nation's 
public health capacity to respond to a national emergency. The SNS is a 
national repository of antibiotics, chemical antidotes, antitoxins, 
life-support medications and medical supplies.
    The SNS, and other federal agencies, http://emergency.cdc.gov/stockpile/index.asp, have plans to address the medical needs of an 
affected population in the event of a disaster. The SNS has large 
quantities of medicine and medical supplies to protect the American 
public if there is a public health emergency (for example, a terrorist 
attack, flu outbreak, or earthquake) severe enough to cause local 
supplies to run out. After federal and local authorities agree that the 
SNS is needed, medicines can be delivered to any state in the U.S. 
within 12 hours. Each state has plans to receive and distribute SNS 
medicine and medical supplies to local communities as 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 will have on hand a 2 to 3 day supply of medical 
supplies at the onset of a disaster. In the event of a prolonged 
emergency response, additional resources may be requested from state 
and federal agencies. CDC's Strategic National Stockpile (SNS), for 
example, has large quantities of medicine and medical supplies for a 
public health emergency that is severe enough to cause local supplies 
to run out and can deliver them to any state in the U.S. in time for 
them to be effective. Each state has plans to receive and distribute 
SNS medicine and medical supplies to local communities as quickly as 
possible. (http://www.cdc.gov/phpr/stockpile/stockpile.html).
    Additional information regarding HHS' core capabilities to support 
public health and medical responses can be found in 2015 FEMA National 
Response Framework (see: http://www.fema.gov/national-response-framework) and more specifically within the Emergency Support Function 
#8 Public Health and Medical Annex that is located at http://www.fema.gov/media-library-data/20130726-1914-25045-5673/final_esf_8_public_health_medical_20130501.pdf. Therefore, based on the 
previous information, we are not assessing additional burden for 
medical supplies.
2. Training Program (Sec.  482.15(d)(1))
    Section 482.15(d)(1) will require hospitals to develop and maintain 
an emergency preparedness training program and review and update it at 
least annually. Based on our experience with healthcare facilities, we 
expect that all healthcare 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 will constitute a 
usual and customary business practice for TJC-accredited hospitals.
    However, under this final rule, non TJC-accredited hospitals will 
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))
    Section 482.15(d)(2)(i) through (iii) will require hospitals to 
participate in or conduct a full-scale exercise and one additional 
testing exercise of their choice 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 three 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). Hospitals can use these 
and other resources, such as tools offered by the DHS, to assist them 
in complying with this requirement. Thus, for non-TJC accredited 
hospitals, the costs associated with this requirement will be primarily 
due to the staff time needed to participate in the testing exercises. 
We believe that appreciable staff time will be required of the risk 
management director, facilities director, safety director, and security 
manager. We expect that other staff members will be required to spend a 
minimal amount of time during these exercises, which will 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 will spend about 12 hours each on an annual basis 
to meet the proposed requirement.
    Thus, we have estimated the economic impact for the 1,345 non-TJC 
accredited hospitals. We anticipate that complying with this 
requirement will require 48 hours for an estimate of $4,992 for each 
non TJC-accredited hospital. Therefore, it will cost all non TJC-
accredited hospitals an estimated total cost of $6,714,240 ($4,992 per 
non

[[Page 64014]]

TJC-accredited hospital x 1,345 hospitals = $6,714,240).
    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 testing 
exercises will constitute a usual and customary business practice and 
we will not include this activity in the economic impact analysis. We 
have estimated that the total economic impact of this final rule on 
hospitals will be $46,140,139 ($6,714,240 testing exercises impact cost 
+ $39,425,899 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, will not have to stockpile supplies in an emergency 
or conduct testing exercises.

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

1. Subsistence (Sec.  483.73(b)(1))
    Section 483.73(b)(1) will 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 will 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 will 
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 483.73(d)(2)(i) through (iii) will require LTC facilities 
to participate in or conduct a full-scale exercise and one additional 
testing exercise of their choice 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 (Sec.  483.75(m)(2)). Thus, we expect that 
complying with the requirement for annual testing of their emergency 
plan will constitute a minimal economic impact, if any.
    Therefore, the cost of this final rule for all LTC Facilities will 
be limited to the ICR burden of $68,808,717 as discussed in the COI 
section.

L. Condition of Participation: Emergency Preparedness for Intermediate 
Care Facilities for Individuals With Intellectual Disabilities (ICFs/
IID)--Testing (Sec.  483.475(d)(2))

    Section 483.475(d)(2)(i) through (iii) will require ICFs/IID to 
participate in or conduct a full scale exercise and one additional 
testing exercise of their choice 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 (Sec.  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 (Sec.  483.470(i)(2)). 
Since all 6,237 ICFs/IID already conduct quarterly drills, we estimate 
a small additional burden to cover the added complexities of the rule. 
Specifically, the rule would require the administrator and the 
registered nurse each to spend an additional hour to participate in 
testing programs for their facility. Thus, we estimate that the 
additional cost for each ICF/IID to comply with this requirement would 
be $157 for each facility. The total estimate for all facilities to 
comply with this requirement is $979,209 ($157 x 6,237 facilities = 
$979,209). We estimate the total cost will be $22,303,512 ($21,324,303 
ICR burden + $979,209 impact cost).

M. 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 $72,678,600.
    Section 484.22(d)(2)(i) through (iii) will require HHAs to 
participate in a full-scale exercise and one additional testing 
exercise of their choice at least annually. We also require the HHA to 
maintain documentation of the testing exercises.
    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). 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. HHS' 
Office of the Assistant Secretary for Preparedness and Response (ASPR) 
and HHS's Centers for Disease Control and Prevention (CDC) also 
provides numerous tools and resources on their Web site (see http://www.cdc.gov/phpr/healthcare/planning.html) in addition to the many 
tools and free online training sessions that are offered on FEMA's 
Emergency Management Institute (EMI) Web site (https://training.fema.gov/emi.aspx). Thus, we believe that the cost associated 
with this requirement will be limited to the staff time to participate 
in the community-wide and facility-wide trainings, and testing 
exercises. We believe that appreciable staff time will be required of 
the administrator and director of training. We believe that other staff 
members will be required to spend a minimal amount of time during these 
exercises and the training will be considered as part of regular on-
going training for HHA staff. We estimate that the administrator will 
spend about 2 hours to participate in the testing exercises. We also 
estimate that the director of training will spend a total of 3 hours on 
an annual basis to participate in the testing exercises. All TJC 
accredited HHAs are required annually to test their emergency 
management program by conducting drills and documenting their results. 
Thus, we anticipate that only non-TJC accredited HHAs will need to 
comply with this requirement. We anticipate that it will require 5 
hours for each of the 8,005 non-JC-accredited HHAs, with an

[[Page 64015]]

estimated cost of $2,945,840. Therefore, the total economic impact of 
this rule on HHAs will be $75,624,440 ($2,945,840 impact cost + 
$72,678,600 ICR burden).

N. Conditions of Participation: Comprehensive Outpatient Rehabilitation 
Facilities (CORFs)--Training and Testing (Sec.  485.68(d)(2)(i) Through 
(iii))

    Section 485.68(d)(2)(i) through (iii) will require CORFs to 
participate in or conduct a full-scale exercise and one additional 
exercise of their choice at least annually and document the testing 
exercises. To comply with this requirement, a CORF will need to develop 
a specific scenario for each exercise.
    The current CoPs require CORFs to provide ongoing drills for all 
personnel associated with the facility in all aspects of disaster 
preparedness (Sec.  485.64(b)(1)). Thus, for the purpose of this 
analysis, we believe that CORFs will incur minimal or no additional 
cost to comply with this requirement. Thus, we estimate the cost for 
all 205 CORFs to comply with this requirement will be limited to the 
ICR burden of $931,520 discussed in the COI section.

O. Condition of Participation: Emergency Preparedness for Critical 
Access Hospitals (CAHs) Training and Testing (Sec.  485.625(d)(2))

    Section 485.625(d)(2)(i) through (iii) will require CAHs to conduct 
two annual testing exercises. Accredited CAHs are currently required to 
conduct such drills and exercises (See COI section for detailed 
discussion regarding our review of accrediting organizations). 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 
will be required under this final rule. Thus, we will analyze the 
economic impact for these requirements for the 892 non-accredited CAHs. 
As discussed earlier in the preamble, CAHs will 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 will be limited to staff time to 
participate in the community-wide and facility-wide trainings, and 
testing exercises. We believe that appreciable staff time will be 
required of the administrator, facilities director, director of nursing 
and nursing education coordinator. We believe that other staff members 
will be required to spend a minimal amount of time during these 
exercises that will be considered as part of regular on-going training 
for hospital staff. We estimate that the administrator (for 7 hours), 
facilities director (for 6 hours), and the director of nursing (for 7 
hours) will spend approximately a total of 20 hours on an annual basis 
to participate in the testing exercises. Thus, we anticipate that 
complying with this requirement will require 20 hours for an estimated 
cost of $1,856 for each of the 892 non-accredited CAHs. Therefore, for 
all non-accredited CAHs to comply with this requirement, it will 
require 17,800 total economic impact hours (20 economic impact hours 
per non-accredited CAH x 892 non-accredited CAH) at an estimated total 
cost of $1,655,552 ($1,856 x 892). Therefore, the total economic impact 
of this rule on CAHs will be $10,830,910 ($1,655,552 testing exercises 
impact cost + $9,175,358 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 will 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 will be minimal, if any. Therefore, the 
total economic impact of this rule on these organizations will be 
limited to the estimated ICR burden of $9,586,150.

Q. Condition of Participation: Emergency Preparedness for Community 
Mental Health Centers (CMHCs)--Training and Testing (Sec.  485.920(d))

    Section 485.920(d)(2) will require CMHCs to participate in or 
conduct a full-scale exercise and one additional testing exercise of 
their choice at least annually. We estimate that to comply with the 
requirement to participate in these testing exercises annually will 
primarily require the involvement of the administrator and a registered 
nurse. We estimate that the administrator will spend approximately 5 
hours to participate in these testing exercises. We also estimate that 
a nurse will spend about 3 hours on an annual basis to participate in 
the testing exercises. Thus, we anticipate that complying with this 
requirement will require 8 hours for each CMHC at an estimated cost of 
$683 for each facility. The economic impact for all 198 CMHCs will be 
135,234 ($683 x 198 CMHCs). Therefore, the total economic impact of 
this final rule on CMHCs will be $1,094,940 ($135,234 impact cost + 
$959,706 ICR burden).

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 testing exercises. We estimate that these tasks will require 
the quality assessment and performance improvement (QAPI) director and 
the education coordinator to each spend 1 hour to participate in the 
testing exercises. Thus, the total annual economic impact hours for 
each OPO will be 2 hours. The total cost will be $188 for a (QAPI 
coordinator hourly salary and the Education Coordinator to 
participate). The economic impact for all OPOs will be 188 (2 impact 
hours x 58 OPOs) total economic impact hours at an estimated cost of 
$10,904 (188 x 58 OPOs). Therefore, the total economic impact of this 
rule on OPOs will be $1,126,186 ($10,904 impact cost + $1,115,282 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 proposed 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 will review their emergency preparedness policies and 
procedures annually. Based on our experience with Medicare providers 
and suppliers, healthcare facilities 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

[[Page 64016]]

procedures will constitute a minimal economic impact, if any.
2. Testing (Sec.  491.12(d)(2)(i) Through (iii))
    Section 491.12(d)(2)(i) through (iii) will require RHCs/FQHCs to 
participate in a full-scale exercise and one additional testing 
exercise of their choice 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 will constitute a 
minimal economic impact, if any. Thus, we are estimating the economic 
impact for RHCs to comply with these requirements to conduct testing 
exercises. We estimate that a RHCs administrator will spend 4 hours 
annually to participate in the exercises. Also, we estimate that a 
nurse coordinator (registered nurse) will each spend 4 hours on an 
annual basis to participate in the testing exercises. Thus, we 
anticipate that complying with this requirement will require 8 hours 
for each RHC for an estimated cost of $672 per facility. The total 
annual cost for 4,200 RHCs will be $4,905,600. Therefore, the total 
economic impact of this rule on RHCs/FQHCs will be $57,372,600 
($4,905,600 impact cost + $52,467,000 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))

    Section 494.62(d)(2) will require dialysis facilities to 
participate in or conduct a full-scale exercise and one additional 
testing exercise of their choice 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 will need to add the additional testing 
exercise of their choice to their emergency preparedness activities. We 
estimate that it will require 1 hour each for the administrator (hourly 
wage of $106.00) and the nurse manager (hourly wage of $94.00) to 
conduct the additional exercise. We estimate the total cost to be $200 
for each facility, with a total economic impact of $1,329,600 ($200 x 
6,648 facilities). Therefore, the total economic impact of this rule on 
ESRD facilities will be $32,960,784 ($1,329,600 impact cost + 
$31,631,184 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 129--Total Annual Cost To Participate in Disaster Drills Across
                         the Providers/Suppliers
------------------------------------------------------------------------
                                             Number of    Total cost (in
                Facility                   participants     millions $)
------------------------------------------------------------------------
RNHCI...................................              18            0.01
ASC.....................................           5,485            3.97
Hospices................................           4,401            2.46
PRTFs...................................             377            0.24
PACE....................................             119            0.02
Hospital................................           4,793            6.71
HHAs....................................          12,335            2.95
CAHs....................................           1,337            1.66
CMHCs...................................             198            0.14
OPOs....................................              58            0.01
RHCs & FQHCs............................          11,500            4.91
ESRD....................................           6,648            1.33
                                         -------------------------------
    Total...............................          47,269           25.37
------------------------------------------------------------------------

    Based upon the ICR and RIA analyses, it will require 62,968 
providers and suppliers covered by this emergency preparedness final 
rule to comply with all of its requirements with an estimated total 
first-year cost of $373 million. After the initial cost of $373 million 
associated with conducting a risk assessment and developing an EP plan, 
the annual cost for the total providers and suppliers to test their 
plans and train staff will be $25 million.

  Table 130--Total Estimated Cost From ICR and RIA To Comply With the Requirements Contained in This Final Rule
----------------------------------------------------------------------------------------------------------------
                                                                                                  Total cost in
                                                                                Total cost in      year 2 and
                          Facility                               Number of       year 1 (in     subsequent years
                                                               participants    millions of $)    (in millions of
                                                                                                       $)
----------------------------------------------------------------------------------------------------------------
RNHCI.......................................................              18              0.04              0.01
ASC.........................................................           5,485             22.37              3.97
Hospices....................................................           4,401             22.43              2.46
PRTFs.......................................................             377              1.47              0.24
PACE........................................................             119              0.65              0.02
Hospital....................................................           4,793             46.14              6.71
Transplant Center...........................................             770              0.00              0.00
LTC.........................................................          15,699             68.81              0.00
ICF/IID.....................................................           6,237             22.30              0.98

[[Page 64017]]

 
HHAs........................................................          12,335             75.62              2.95
CORFs.......................................................             205              0.93              0.00
CAHs........................................................           1,337             10.83              1.66
Organizations...............................................           2,135              9.59              0.00
CMHCs.......................................................             198              1.09              0.14
OPOs........................................................              58              1.13              0.01
RHCs & FQHCs................................................          11,500             57.37              4.91
ESRD Facilities.............................................           6,648             34.29              1.33
                                                             ---------------------------------------------------
    Total...................................................          72,315              $373               $25
----------------------------------------------------------------------------------------------------------------

    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 final rule's requirements allows an 
ESRD facility to remain open during and immediately after a natural 
disaster, there will be associated increases in provision of dialysis 
services, thus entailing labor, material and other costs. As discussed 
in the next section (``Benefits of the Final Rule''), it is difficult 
to predict how disaster responses will be different in the presence of 
this final rule than in its absence, so we have been unable to quantify 
the portion of costs that will be incurred during emergencies.

V. Benefits of the Final Rule

    The Presidential Policy Directive/PPD-8 is aimed at strengthening 
the security and resilience of the United States through systematic 
preparation for the threats that pose the greatest risk to the security 
of the nation, including acts of terrorism, cyber-attacks, pandemics, 
and catastrophic natural disasters. (https://www.dhs.gov/presidential-policy-directive-8-national-preparedness). ``Having systems in place to 
provide better treatment for disaster survivors and improved public 
health for our communities also leads to better health outcomes on a 
day-to-day basis.'' http://www.phe.gov/Preparedness/planning/hpp/Pages/funding.aspx. 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. Based on our experience, hospitals currently, 
either through experience or empirical evidence, gain knowledge that 
causes them to become very adept at adjusting 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 final rule serves to help ensure continuity of care and 
service delivery for those that depend on the healthcare system both 
daily and in the event of a disaster 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 
healthcare services were not available for many who needed them. 
Rudowitz, Robin, Diane Rowland, and Adele Shartzer. ``Health care in 
New Orleans before and after Hurricane Katrina.'' Health Affairs 
25.5(2006): w393-w406. . There is no reason to believe that future 
disasters might not be as large or larger. In the event of such 
disasters, vulnerable populations are at greatest risk for negative 
consequences from healthcare disruptions. Individuals requiring mental 
health treatments are another at-risk population that can be adversely 
impacted by healthcare 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. 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. (Absorbing citywide 
patient surge during Hurricane Sandy: a case study in accommodating 
multiple hospital evacuations.) (Ann Emerg Med. 2014 Jul ;64(1):66-
73.e1. doi: 10.1016/j.annemergmed.2013.12.010. Epub 2014 Jan 10.); 
(Howard D, Zhang R, Huang Y, Kutner N. Hospitalization rates among 
dialysis patients during Hurricane Katrina. Prehosp Disaster Med. 
2012;27(4):1-5.).)
    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,

[[Page 64018]]

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 this final rule will reduce the risk of 
mortality and morbidity associated with disasters. 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. A recent report, ``In the path of the Storm'' 
(http://www.environmentamerica.org/reports/ame/path-storm) that studied 
FEMA disaster declaration and other data from 2007 through 2012 found 
that federally declared weather-related disasters in the United States 
have taken place in every state except for one, and affected every 
county in 18 states and the District of Columbia. It also found that 
more than 19 million Americans live in counties that have an average of 
one or more weather-related disasters per year since the beginning of 
2007.'' (http://www.environmentamerica.org/reports/ame/path-storm). 
Sometimes, these disasters can have adverse impacts on the health of 
communities. For example, more than 15,000 dialysis patients located 
within the State of New Jersey and New York City boroughs were exposed 
to the impacts of Hurricane Sandy that resulted in significant 
treatment disruptions. (Kelman, Jeffrey, et al. ``Dialysis care and 
death following Hurricane Sandy.'' American Journal of Kidney Diseases 
65.1 (2015): 109-115).
    The White House, in July 2014, also released a report titled ``The 
Health Impacts of Climate Change on Americans'' (https://www.whitehouse.gov/sites/default/files/docs/the_health_impacts_of_climate_change_on_americans_final.pdf). The 
report states that extreme heat exposures for the period of 1999-2009 
caused more than 7,800 deaths in the U.S. As climate change progresses, 
extreme heat will ``also increase hospital admissions for 
cardiovascular, respiratory, cerebrovascular diseases and deaths from 
heat stroke and other related conditions (https://health2016.globalchange.gov.'' On April 4, 2016, The White House also 
published the Climate and Health Assessment Report'' (https://www.whitehouse.gov/the-press-office/2016/04/04/fact-sheet-what-climate-change-means-your-health-and-family (actual report: https://health2016.globalchange.gov/) that provides a comprehensive, evidenced-
based, and where possible quantitative estimation of observed and 
projected public health impacts related to climate change in the U.S. 
that will also inform state, and local governments and communities on 
climate change risks. (see https://www.whitehouse.gov/sites/default/files/docs/the_health_impacts_of_climate_change_on_americans_final.pdf 
and http://www.globalchange.gov/health-assessment.
    According to the CDC, changing climate is linked to increases in a 
wide range of non-communicable and infectious diseases. There are 
complex ways in which climatic factors (like temperature, humidity, 
precipitation, extreme weather events, and sea-level rise) can directly 
or indirectly affect the prevalence of disease. Identification of 
communities and places vulnerable to these changes can help healthcare 
providers prepare to work with health departments as they assess such 
health vulnerabilities associated with climate change and prevent 
associated adverse health impacts. CDC has developed the Building 
Resilience Against Climate Effects (BRACE) framework to help health 
departments prepare for and respond to climate change. Additional 
information can be found at: http://www.cdc.gov/climateandhealth/brace.htm.
    While we are unable to quantify the number of lives that could be 
saved by emergency planning and execution, Table 131 provides the 
number of Medicare FFS beneficiaries receiving services from some of 
the provider types affected by this final rule during the month of May 
2016. We are unable to provide volume data for those patients in 
Medicare Advantage plans or the Medicaid population. However, one could 
assume the May 2016 summary is representative of an average month 
during the year. In the event of a disaster, a portion of the fee-for-
service patients represented in Table 131 could be at risk; therefore, 
we could assume that they could benefit from the additional emergency 
preparedness measures in this final rule.

  Table 131--Number of Medicare FFS Patients Who Received Services May
                                  2016
------------------------------------------------------------------------
                                                           Number of FFS
                      Provider type                          patients
------------------------------------------------------------------------
Children's hospital.....................................           3,731
Community Mental Health Center..........................          96,583
Comprehensive Outpatient Rehabilitation Facility........           3,673
Critical Access Hospital................................         685,912
HHA.....................................................       1,043,827
Hospice.................................................         322,565
Hospital based chronic renal disease facility...........           7,700
Long[dash]term hospital.................................          18,842
Non hospital renal disease treatment center.............         280,189
ORD demonstration project hospital......................           3,078

[[Page 64019]]

 
Psychiatric hospital....................................          37,975
Rehabilitation hospital.................................          45,995
Religious Nonmedical Health Care Institution............              29
Renal disease treatment center..........................           7,221
Reserved number.........................................          68,734
Rural health clinic (free standing).....................         208,942
Rural health clinic (provider based)....................         325,051
Short[dash]term hospital................................       7,104,897
Skilled Nursing Facility................................         539,061
------------------------------------------------------------------------
Note: In May 2016 there were 9,283,219 distinct patients.

    Benefits from effective disaster planning will not only accrue to 
individuals requiring healthcare services. Healthcare facilities 
themselves may benefit from improved ability to maintain or resume 
delivering services. After Hurricane Katrina, 94 dialysis facilities 
closed for at least 1 week. More than a month after super storm Sandy 
devastated flood-prone communities in New Jersey and New York, five 
hospitals were unable to admit patients because of damage that 
destroyed electrical systems, flooded emergency and exam rooms and 
crippled elevators. Following Hurricane Sandy, $180 million of the $810 
million damages reported by the New York City Health and Hospitals 
Corporation was due to lost revenue. Lost revenue from Long Beach 
Medical Center hospital and nursing home was estimated at $1.85 million 
a week after closing due to damage from Hurricane Sandy. http://www.modernhealthcare.com/article/20121208/MAGAZINE/312089991#ixzz2adUDjFIE?trk=tynt.
    Finally, taxpayers and insurance companies may benefit from 
effective emergency preparedness. After Hurricane Ike, it was estimated 
that the cost to Medicare for ESRD patients presenting to the ED for 
dialysis instead of their usual facility was, on average, $6,997 per 
visit. Those ESRD patients who did not require dialysis were billed 
$482 on average (McGinley et al, 2012). The usual cost for these 
patients as reimbursed through Medicare is in the order of $250 to 300 
per visit. Many of these costs or lost revenues may be mitigated by 
effective emergency preparedness planning. For a non-ESRD individual 
who cannot receive care from his or her office-based physician but must 
instead go to an emergency room, not only are the individual's costs 
increased, but reimbursement through Medicare, Medicaid or private 
insurance is also increased. AHRQ's Medical Expenditure Panel Survey 
from 2008 notes that the average expense for an office based visit was 
$199 versus $922 for an emergency room visit (Machlin, S., and 
Chowdhury, S. ``Expenses and Characteristics of Physician Visits in 
Different Ambulatory Care Settings, 2008.'' Statistical Brief #318. 
March 2011. Agency for Healthcare Research and Quality, Rockville, MD. 
http://www.meps.ahrq.gov/mepsweb/data_files/publications/st318/stat318.pdf).
    With the annualized costs of the rule's emergency preparedness 
requirements estimated to be approximately $100 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 final rule will have to 
result in at least $100 million in average yearly benefits, principally 
derived from reductions in morbidity and mortality, for the benefits to 
equal or exceed costs. ASPR and CMS, using Medicare claims data, 
conducted an analysis of the impact of Hurricane Sandy on dialysis-
dependent ESRD patients. The study found a significant increase in 
emergency department visits, hospitalizations, and 30-day mortality for 
ESRD patients living in the areas most affected by the storm (Kelman, 
et al.). Approximately 23 percent of the study patients who had an 
emergency visit also received dialysis in the ED during their visits 
(Kelman, et al.). (Kelman, Jeffrey, et al. ``Dialysis care and death 
following Hurricane Sandy.'' American Journal of Kidney Diseases 65.1 
(2015): 109-115.) Adoption of the following requirements in this final 
rule will 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 will decrease the rate of 
interrupted dialysis, thereby reducing preventable ED visits, 
hospitalizations, and mortality during and following disasters.

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 was to propose a regulation that 
would require Medicare providers and suppliers to comply with local, 
state and federal laws regarding emergency and 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 healthcare 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

[[Page 64020]]

that disaster preparedness was not identified as a top issue. We 
believe that absent conditions of participation, certification, and 
coverage, providers and suppliers will 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, healthcare 
organizations, and citizens during a disaster. In addition, our 
regulations will enable us to survey and enforce the emergency 
preparedness requirements using standard processes and criteria.
3. 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 healthcare providers and suppliers 
is an urgent public health issue. Therefore, we are finalizing 
emergency preparedness requirements that are consistent and enforceable 
for all Medicare and Medicaid providers and suppliers. This final rule 
addresses the three key elements needed to ensure that healthcare 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. Costs to Federal Government

    Surveyors will be trained and interpretive guidelines will be 
developed. If these requirements are finalized, we will update the 
interpretive guidance, update the survey process, and make IT systems 
changes. In order to implement these new standards, we anticipate 
initial federal start-up costs to be $700,000. Once implemented, 
surveys will begin in FY17 and we anticipate initial costs for these 
surveys to carry into FY18 due to the survey cycle. Therefore, we 
anticipate approximately $4,411,286 for FY18 with a decrease in 
subsequent years to an estimated $3,749,593 annually in federal costs.

Y. 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 132--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)........             104            2015              7%       2016-2020
                                                              99            2015              3%       2016-2020
                                                 ---------------------------------------------------------------
    Qualitative.................................      Costs of performing life-saving and morbidity-reducing
                                                                activities during emergency events.
----------------------------------------------------------------------------------------------------------------

    In accordance with the provisions of Executive Order 12866, this 
final rule was reviewed by the Office of Management and Budget.
    Comment: A commenter stated that the figures used for economic 
impact, not including the ICR burden are underestimated by 45 percent. 
Several other commenters stated that they believe that our projections 
of burden and cost for compliance with the proposed rule are 
underestimated. They stated that many hospitals, especially smaller 
hospitals, have expressed concern about the financial implications for 
compliance with certain provisions, especially the additional generator 
testing. In addition, they stated that we underestimated the amount of 
time and work it will take many providers and suppliers to come into 
compliance with the proposed requirements. For example, tasks such as 
updating policies and procedures involve more than assembling key 
hospital staff to attend a limited number of meetings, draft revisions 
and obtain approval. Updating policies and procedures also involves 
researching alternatives, assessing any costs involved (such as 
technology that may be needed), reviewing potential changes with 
employees who may be affected, implementing the changes, training staff 
and testing outcomes.
    Response: We appreciate all of the public comments we received 
regarding the cost and burden estimates for this rule. We carefully 
reviewed the public comments and have discussed many of the comments 
that will reduce burden under previous sections of this rule. We have 
increased the overhead cost to 100 percent of salary. In addition, 
based on our experience with the Medicare and Medicaid providers, most 
providers have some type of an emergency plan and agree that it is very 
important to appropriately plan for a potential emergency or disaster. 
We believe that these providers currently inform or train their staff 
on some type of an emergency plan with various degrees of 
effectiveness. We realize that these requirements will require 
providers and suppliers to consistently conduct additional assessment, 
and development of policies and procedures and have added additional 
cost for the projected personnel time associated with this rule.

[[Page 64021]]

    As previously discussed, we will remove the burden and cost for 
hospitals, CAHs and LTC facilities to conduct an additional testing of 
their generators. We have also provided flexibility under the training 
and testing requirements and we have increased the salary cost for the 
staff that will participate in complying with this rule.

VI. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposal. The notice 
of proposed rule includes a reference to the legal authority under 
which the rule is proposed, and the terms and substance of the proposed 
rule or a description of the subjects and issues involved. This 
procedure can be waived, however, if an agency finds good cause that a 
notice-and-comment procedure is impracticable, unnecessary, or contrary 
to the public interest and incorporates a statement of the finding and 
its reasons in the rule issued.
    In various sections of the December 2013 proposed rule (78 FR 
79101), we referenced the latest version of the Life Safety Code 
(NFPA[supreg] 101), the Health Care Facilities Code (NFPA[supreg] 99) 
and the Standard for Standby Power Generators (NFPA[supreg] 110). In 
the May 4, 2016 Federal Register (81 FR 26872) we published a final 
rule, ``Medicare and Medicaid Programs: Fire Safety Requirements for 
Certain Health Care Facilities'', which incorporated by reference the 
2012 editions of NFPA[supreg] 101, ``Life Safety Code'' and 
NFPA[supreg] 99, ``Health Care Facilities Code'' into our regulations. 
In a similar manner in this final rule, we are incorporating by 
reference the 2012 editions of NFPA[supreg] 101, ``Life Safety Code'' 
and NFPA[supreg] 99, ``Health Care Facilities Code'' as well as the 
2010 edition of NFPA[supreg] 110, Standard for Emergency and Standby 
Power Systems. Because the December 2013 proposed rule referred to and 
discussed incorporation of earlier versions of these NFPA documents, we 
believe that engaging in a new round of notice-and-comment rulemaking 
to propose an update to these codes, which have already been 
incorporated into our general fire safety regulations, would be both 
unnecessary and contrary to the public interest. Therefore, we find 
good cause to waive the notice of proposed rulemaking related to these 
changes.

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, Incorporation by 
reference, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 483

    Grant programs-health, Health facilities, Health professions, 
Health records, Incorporation by Reference, 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, Incorporation by 
Reference, 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 amends 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).


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 read as follows:


Sec.  403.748  Condition of participation: Emergency preparedness.

    The Religious Nonmedical Health Care Institution (RNHCI) must 
comply with all applicable Federal, State, and local 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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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

[[Page 64022]]

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 on-duty staff and sheltered 
patients in the RNHCI's care during an emergency. If on-duty staff and 
sheltered patients are relocated during the emergency, the RNCHI must 
document the specific name and location of the receiving facility or 
other location.
    (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) Secures and maintains the availability of records.
    (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 maintain 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 Federal, 
State, and local laws 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) 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 
maintain the 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(b)(1)(ii).
    (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 is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program 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) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The RNHCI must conduct exercises to test the emergency 
plan. The RNHCI must do the following:
    (i) Conduct a paper-based, tabletop exercise at least annually. A 
tabletop exercise is a group discussion led by a facilitator, using a 
narrated, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (ii) Analyze the RNHCI's response to and maintain documentation of 
all tabletop exercises, and emergency events, and revise the RNHCI's 
emergency plan, as needed.

PART 416--AMBULATORY SURGICAL SERVICES

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, State, and local 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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency

[[Page 64023]]

preparedness officials' efforts to maintain 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 on-duty staff and sheltered 
patients in the ASC's care during an emergency. If on-duty staff or 
sheltered patients are relocated during the emergency, the ASC must 
document the specific name and location of the receiving facility or 
other location.
    (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) Secures and maintains the availability of records.
    (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 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 Federal, 
State, and local laws 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) 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 maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (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 is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program 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) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The ASC must conduct exercises to test the emergency 
plan at least annually. The ASC must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, individual, 
facility-based. 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 an community-based or individual, facility-
based full-scale exercise for 1 year following the onset of the actual 
event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is individual, facility-
based.
    (B) A tabletop exercise that includes 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.
    (iii) 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.
    (e) Integrated healthcare systems. If an ASC is part of a 
healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the ASC may choose to participate in 
the healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program 
must--
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements

[[Page 64024]]

set forth in paragraph (b) of this section, a coordinated communication 
plan and training and testing programs that meet the requirements of 
paragraphs (c) and (d) of this section, respectively.

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).


Sec.  418.110  [Amended]

0
8. Amend Sec.  418.110 by removing paragraph (c)(1)(ii) and the 
paragraph designation (i) from paragraph (c)(1)(i).

0
9. Add Sec.  418.113 to read as follows:


Sec.  418.113  Condition of participation: Emergency preparedness.

    The hospice must comply with all applicable Federal, State, and 
local 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 cooperation and collaboration with local, 
tribal, regional, State, or Federal emergency preparedness officials' 
efforts to maintain 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) Procedures to follow up with on-duty staff and patients to 
determine services that are needed, in the event that there is an 
interruption in services during or due to an emergency. The hospice 
must inform State and local officials of any on-duty staff or patients 
that they are unable to contact.
    (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 
secures and maintains the availability of records.
    (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 maintain 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, medical, and pharmaceutical 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.
    (v) A system to track the location of hospice employees' on-duty 
and sheltered patients in the hospice's care during an emergency. If 
the on-duty employees or sheltered patients are relocated during the 
emergency, the hospice must document the specific name and location of 
the receiving facility or other location.
    (c) Communication plan. The hospice must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws 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 maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (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

[[Page 64025]]

testing program that is based on the emergency plan set forth in 
paragraph (a) of this section, risk assessment at paragraph (a)(1) of 
this section, policies and procedures at paragraph (b) of this section, 
and the communication plan at paragraph (c) of this section. The 
training and testing program 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) Demonstrate staff knowledge of emergency procedures.
    (iii) Provide emergency preparedness training at least annually.
    (iv) Periodically review and rehearse its emergency preparedness 
plan with hospice employees (including nonemployee staff), with special 
emphasis placed on carrying out the procedures necessary to protect 
patients and others.
    (v) Maintain documentation of all emergency preparedness training.
    (2) Testing. The hospice must conduct exercises to test the 
emergency plan at least annually. The hospice must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If the hospice experiences an actual natural or man-
made emergency that requires activation of the emergency plan, the 
hospital is exempt from engaging in a community-based or individual, 
facility-based full-scale exercise for 1 year following the onset of 
the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) 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.
    (e) Integrated healthcare systems. If a hospice is part of a 
healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the hospice may choose to participate 
in the healthcare system's coordinated emergency preparedness program. 
If elected, the unified and integrated emergency preparedness program 
must do the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

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

0
10. The authority citation for part 441 continues to read as follows:

    Authority: Secs. 1102, 1902, and 1928 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, State, and local 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 for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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, medical, and pharmaceutical 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 on-duty staff and sheltered 
residents in the PRTF's care during and after an emergency. If on-duty 
staff and sheltered residents are relocated during the emergency, the 
PRTF must document the specific name and location of the receiving 
facility or other location.
    (3) Safe evacuation from the PRTF, which includes consideration of 
care and treatment needs of evacuees; staff responsibilities; 
transportation; identification of evacuation location(s);

[[Page 64026]]

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 
secures and maintains the availability of records.
    (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 maintain 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 Federal, 
State, and local laws 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 maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release resident 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (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 is based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, policies and procedures at paragraph 
(b) of this section, and the communication plan at paragraph (c) of 
this section. The training and testing program must be reviewed and 
updated at least annually.
    (1) Training program. The PRTF must do all of the following:
    (i) Provide initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing 
services under arrangement, and volunteers, consistent with their 
expected roles.
    (ii) After initial training, provide emergency preparedness 
training at least annually.
    (iii) Demonstrate staff 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 full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. 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-based or individual, facility-based 
full-scale exercise for 1 year following the onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) Analyze the PRTF's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events and revise the 
PRTF's emergency plan, as needed.
    (e) Integrated healthcare systems. If a PRTF is part of a 
healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the PRTF may choose to participate in 
the healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program must 
do the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

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 and reserving 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, State, and local 
emergency preparedness requirements. The PACE organization must 
establish and maintain an emergency preparedness

[[Page 64027]]

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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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) The provision of subsistence needs for staff and participants, 
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 participant 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 on-duty staff and sheltered 
participants under the PACE center(s) care during and after an 
emergency. If on-duty staff and sheltered participants are relocated 
during the emergency, the PACE must document the specific name and 
location of the receiving facility or other location.
    (3) 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.
    (4) 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 
participant's medical and psychiatric conditions and home environment.
    (5) A means to shelter in place for participants, staff, and 
volunteers who remain in the facility.
    (6) A system of medical documentation that preserves participant 
information, protects confidentiality of participant information, and 
secures and maintains the availability of records.
    (7) 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.
    (8) 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 maintain the continuity of 
services to PACE participants.
    (9) 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.
    (10)(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 Federal, State, and local laws 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.
    (4) A method for sharing information and medical documentation for 
participants under the organization's care, as necessary, with other 
health care providers to maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release participant 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (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 is 
based on the emergency plan set forth in paragraph (a) of this section, 
risk assessment at paragraph (a)(1) of this section, policies and 
procedures at paragraph (b) of this section, and the communication plan 
at paragraph (c) of this section. The training and testing program 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) Demonstrate staff knowledge of emergency procedures, 
including

[[Page 64028]]

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 at least annually. The PACE organization must do the 
following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If the PACE experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the PACE is 
exempt from engaging in a community-based or individual, facility-based 
full-scale exercise for 1 year following the onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) 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.
    (e) Integrated healthcare systems. If a PACE is part of a 
healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the PACE may choose to participate in 
the healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program 
must--
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, participant 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

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, State, and 
local 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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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, medical, and pharmaceutical 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 on-duty staff and sheltered 
patients in the hospital's care during an emergency. If on-duty staff 
and sheltered patients are relocated during the emergency, the hospital 
must document the specific name and location of the receiving facility 
or other location.
    (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 
secures and maintains the availability of records.
    (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

[[Page 64029]]

maintain 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 Federal, 
State, and local laws and must be reviewed and updated at least 
annually. The communication plan must include all of the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Patients' physicians.
    (iv) Other hospitals and 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) 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 maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (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 is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program 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) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The hospital must conduct exercises to test the 
emergency plan at least annually. The hospital must do all of the 
following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. 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-based or individual, 
facility-based full-scale exercise for 1 year following the onset of 
the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) 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)(1)(i) and (ii) of this 
section.
    (1) Emergency generator location. The generator must be located in 
accordance with the location requirements found in the Health Care 
Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 
12-3, TIA 12-4, TIA 12-5, and TIA 12-6), Life Safety Code (NFPA 101 and 
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing 
structure or building is renovated.
    (2) Emergency generator inspection and testing. The hospital must 
implement the emergency power system inspection, testing, and 
maintenance requirements found in the Health Care Facilities Code, NFPA 
110, and Life Safety Code.
    (3) Emergency generator fuel. Hospitals that maintain an onsite 
fuel source to power emergency generators must have a plan for how it 
will keep emergency power systems operational during the emergency, 
unless it evacuates.
    (f) Integrated healthcare systems. If a hospital is part of a 
healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the hospital may choose to participate 
in the healthcare system's coordinated emergency preparedness program. 
If elected, the unified and integrated emergency preparedness program 
must--
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.
    (g) Transplant hospitals. If a hospital has one or more transplant 
centers (as defined in Sec.  482.70)--
    (1) A representative from each transplant center must be included 
in the development and maintenance of the hospital's emergency 
preparedness program; and
    (2) The hospital must develop and maintain mutually agreed upon 
protocols that address the duties and responsibilities of the hospital, 
each

[[Page 64030]]

transplant center, and the OPO for the DSA where the hospital is 
situated, unless the hospital has been granted a waiver to work with 
another OPO, during an emergency.
    (h) The standards incorporated by reference in this section are 
approved for incorporation by reference by the Director of the Office 
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. You may obtain the material from the sources listed below. You 
may inspect a copy at the CMS Information Resource Center, 7500 
Security Boulevard, Baltimore, MD or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. If any changes in this edition of the Code are 
incorporated by reference, CMS will publish a document in the Federal 
Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
    (i) NFPA 99, Health Care Facilities Code, 2012 edition, issued 
August 11, 2011.
    (ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued 
August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011.
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (xiii) NFPA 110, Standard for Emergency and Standby Power Systems, 
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
    (2) [Reserved]

0
17. Revise Sec.  482.68 to read as follows:


Sec.  482.68  Special requirement for transplant centers.

    A transplant center located within a hospital that has a Medicare 
provider agreement must meet the conditions of participation specified 
in Sec. Sec.  482.72 through 482.104 in order to be granted approval 
from CMS to provide transplant services.
    (a) Unless specified otherwise, the conditions of participation at 
Sec. Sec.  482.72 through 482.104 apply to heart, heart-lung, 
intestine, kidney, liver, lung, and pancreas centers.
    (b) In addition to meeting the conditions of participation 
specified in Sec. Sec.  482.72 through 482.104, a transplant center 
must also meet the conditions of participation in Sec. Sec.  482.1 
through 482.57, except for Sec.  482.15.

0
18. Add Sec.  482.78 to read as follows:


Sec.  482.78  Condition of participation: Emergency preparedness for 
transplant centers.

    A transplant center must be included in the emergency preparedness 
planning and the emergency preparedness program as set forth in Sec.  
482.15 for the hospital in which it is located. However, a transplant 
center is not individually responsible for the emergency preparedness 
requirements set forth in Sec.  482.15.
    (a) Standard: Policies and procedures. A transplant center must 
have policies and procedures that address emergency preparedness. These 
policies and procedures must be included in the hospital's emergency 
preparedness program.
    (b) Standard: Protocols with hospital and OPO. A transplant center 
must develop and maintain mutually agreed upon protocols that address 
the duties and responsibilities of the transplant center, the hospital 
in which the transplant center is operated, and the OPO designated by 
the Secretary, unless the hospital has an approved waiver to work with 
another OPO, during an emergency.

PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

0
19. The authority citation for part 483 continues to read as follows:

    Authority: Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social 
Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).


0
20. Add Sec.  483.73 to read as follows:


Sec.  483.73  Emergency preparedness.

    The LTC facility must comply with all applicable Federal, State and 
local 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 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 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 cooperation and collaboration with local, 
tribal, regional, State, or Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation, including documentation of the LTC facility's 
efforts to contact such officials and, when applicable, of its 
participation in collaborative and cooperative planning efforts.
    (b) Policies and procedures. The LTC facility must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least annually. At a minimum, the policies 
and procedures must address the following:
    (1) The provision of subsistence needs for staff and residents, 
whether they evacuate or shelter in place, include, but are not limited 
to the following:
    (i) Food, water, medical, and pharmaceutical 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 on-duty staff and sheltered 
residents in the LTC facility's care during and after an emergency. If 
on-duty staff and sheltered residents are relocated during the 
emergency, the LTC facility must document the specific name and 
location of the receiving facility or other location.
    (3) Safe evacuation from the LTC facility, which includes 
consideration of

[[Page 64031]]

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 
secures and maintains the availability of records.
    (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 maintain 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 
Federal, State, and local laws 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 maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release resident 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (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 is 
based on the emergency plan set forth in paragraph (a) of this section, 
risk assessment at paragraph (a)(1) of this section, policies and 
procedures at paragraph (b) of this section, and the communication plan 
at paragraph (c) of this section. The training and testing program 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) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The LTC facility must conduct exercises to test the 
emergency plan at least annually, including unannounced staff drills 
using the emergency procedures. The LTC facility must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. 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-based or 
individual, facility-based full-scale exercise for 1 year following the 
onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) 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. The generator must be located in 
accordance with the location requirements found in the Health Care 
Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 
12-3, TIA 12-4, TIA 12-5, and TIA 12-6), Life Safety Code (NFPA 101 and 
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing 
structure or building is renovated.
    (2) Emergency generator inspection and testing. The LTC facility 
must implement the emergency power system inspection, testing, and 
maintenance requirements found in the Health Care Facilities Code, NFPA 
110, and Life Safety Code.
    (3) Emergency generator fuel. LTC facilities that maintain an 
onsite fuel source to power emergency generators must have a plan for 
how it will keep emergency power systems operational during the 
emergency, unless it evacuates.
    (f) Integrated healthcare systems. If a LTC facility is part of a 
healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the LTC facility may choose to 
participate in the healthcare system's coordinated emergency 
preparedness program. If elected, the unified and integrated emergency 
preparedness program must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.

[[Page 64032]]

    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and 
include--
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.
    (g) The standards incorporated by reference in this section are 
approved for incorporation by reference by the Director of the Office 
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. You may obtain the material from the sources listed below. You 
may inspect a copy at the CMS Information Resource Center, 7500 
Security Boulevard, Baltimore, MD or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. If any changes in this edition of the Code are 
incorporated by reference, CMS will publish a document in the Federal 
Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
    (i) NFPA 99, Health Care Facilities Code 2012 edition, issued 
August 11, 2011.
    (ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued 
August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011.
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (xiii) NFPA 110, Standard for Emergency and Standby Power Systems, 
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
    (2) [Reserved]


Sec.  483.75  [Amended]

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


Sec.  483.470  [Amended]

0
22. Amend Sec.  483.470 by removing and reserving paragraph (h).

0
23. Add Sec.  483.475 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, State, 
and local 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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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 clients, 
whether they evacuate or shelter in place, include, but are not limited 
to the following:
    (i) Food, water, medical, and pharmaceutical supplies.
    (ii) Alternate sources of energy to maintain the following:
    (A) Temperatures to protect client 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 on-duty staff and sheltered 
clients in the ICF/IID's care during and after an emergency. If on-duty 
staff and sheltered clients are relocated during the emergency, the 
ICF/IID must document the specific name and location of the receiving 
facility or other location.
    (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 
secures and maintains the availability of records.
    (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 maintain 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

[[Page 64033]]

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 Federal, 
State, and local laws 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 maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release client 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (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 is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program 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.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The ICF/IID must conduct exercises to test the 
emergency plan at least annually. The ICF/IID must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. 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-based or individual, 
facility-based full-scale exercise for 1 year following the onset of 
the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) 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.
    (e) Integrated healthcare systems. If an ICF/IID is part of a 
healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the ICF/IID may choose to participate 
in the healthcare system's coordinated emergency preparedness program. 
If elected, the unified and integrated emergency preparedness program 
must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

PART 484--HOME HEALTH SERVICES

0
24. 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
25. 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, State, and local 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 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 HHA has the ability to provide in an emergency; 
and continuity of operations, including

[[Page 64034]]

delegations of authority and succession plans.
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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) The procedures to follow up with on-duty staff and patients to 
determine services that are needed, in the event that there is an 
interruption in services during or due to an emergency. The HHA must 
inform State and local officials of any on-duty staff or patients that 
they are unable to contact.
    (4) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (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.
    (c) Communication plan. The HHA must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws 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) 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 maintain the 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 is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program 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) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The HHA must conduct exercises to test the emergency 
plan at least annually. The HHA must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If the HHA experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the HHA is 
exempt from engaging in a community-based or individual, facility-based 
full-scale exercise for 1 year following the onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) 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.
    (e) Integrated healthcare systems. If a HHA is part of a healthcare 
system consisting of multiple separately certified healthcare 
facilities that elects to have a unified and integrated emergency 
preparedness program, the HHA may choose to participate in the 
healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program must 
do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet

[[Page 64035]]

the requirements of paragraphs (c) and (d) of this section, 
respectively.

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

0
26. 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 and Reserved]

0
27. Remove and reserve Sec.  485.64.

0
28. Add Sec.  485.68 to read as follows:


Sec.  485.68  Condition of participation: Emergency preparedness.

    The Comprehensive Outpatient Rehabilitation Facility (CORF) must 
comply with all applicable Federal, State, and local 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 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 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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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 
secures and maintains the availability of records.
    (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 Federal, 
State, and local laws 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 maintain the 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 is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program 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) Demonstrate staff knowledge of emergency procedures. All new 
personnel must be oriented and assigned specific responsibilities 
regarding the CORF's emergency plan within 2 weeks of their first 
workday. The training program must include instruction in the location 
and use of alarm systems and signals and firefighting equipment.
    (2) Testing. The CORF must conduct exercises to test the emergency 
plan at least annually. The CORF must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. 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-based or individual, facility-based 
full-scale exercise for 1 year following the onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) 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.
    (e) Integrated healthcare systems. If a CORF is part of a 
healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the CORF may choose to participate in 
the healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated

[[Page 64036]]

emergency preparedness program must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.


Sec.  485.623  [Amended]

0
29. Amend Sec.  485.623 by removing paragraph (c) and redesignating 
paragraphs (d) through (f) as paragraphs (c) through (e).

0
30. Adding Sec.  485.625 to subpart F to read as follows:


Sec.  485.625  Condition of participation: Emergency preparedness.

    The CAH must comply with all applicable Federal, State, and local 
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 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 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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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, medical, and pharmaceutical 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 on-duty staff and sheltered 
patients in the CAH's care during an emergency. If on-duty staff and 
sheltered patients are relocated during the emergency, the CAH must 
document the specific name and location of the receiving facility or 
other location.
    (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 
secures and maintains the availability of records.
    (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 maintain 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 Federal, 
State, and local laws 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 and 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) 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 maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (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

[[Page 64037]]

emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program 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 firefighting 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) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The CAH must conduct exercises to test the emergency 
plan at least annually. The CAH must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based exercise. 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-based or individual, 
facility-based full-scale exercise for 1 year following the onset of 
the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) 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. The generator must be located in 
accordance with the location requirements found in the Health Care 
Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 
12-3, TIA 12-4, TIA 12-5, and TIA 12-6), Life Safety Code (NFPA 101 and 
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing 
structure or building is renovated.
    (2) Emergency generator inspection and testing. The CAH must 
implement emergency power system inspection and testing requirements 
found in the Health Care Facilities Code, NFPA 110, and the Life Safety 
Code.
    (3) Emergency generator fuel. CAHs that maintain an onsite fuel 
source to power emergency generators must have a plan for how it will 
keep emergency power systems operational during the emergency, unless 
it evacuates.
    (f) Integrated healthcare systems. If a CAH is part of a healthcare 
system consisting of multiple separately certified healthcare 
facilities that elects to have a unified and integrated emergency 
preparedness program, the CAH may choose to participate in the 
healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program must 
do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and 
include--
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.
    (g) The standards incorporated by reference in this section are 
approved for incorporation by reference by the Director of the Office 
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. You may obtain the material from the sources listed below. You 
may inspect a copy at the CMS Information Resource Center, 7500 
Security Boulevard, Baltimore, MD or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. If any changes in this edition of the Code are 
incorporated by reference, CMS will publish a document in the Federal 
Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
    (i) NFPA 99, Health Care Facilities Code, 2012 edition, issued 
August 11, 2011.
    (ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued 
August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011.
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (xiii) NFPA 110, Standard for Emergency and Standby Power Systems, 
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
    (2) [Reserved]

0
31. 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, 
State, and local

[[Page 64038]]

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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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 
secures and maintains the availability of records.
    (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 
Federal, State, and local laws 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 maintain the 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 is 
based on the emergency plan set forth in paragraph (a) of this section, 
risk assessment at paragraph (a)(1) of this section, policies and 
procedures at paragraph (b) of this section, and the communication plan 
at paragraph (c) of this section. The training and testing program 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) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The Organizations must conduct exercises to test the 
emergency plan at least annually. The Organizations must do the 
following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If the Organizations experience an actual natural or 
man-made emergency that requires activation of the emergency plan, the 
organization is exempt from engaging in a community-based or 
individual, facility-based full-scale exercise for 1 year following the 
onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) Analyze the Organization's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise their emergency plan, as needed.
    (e) Integrated healthcare systems. If the Organizations are part of 
a healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the Organizations may choose to 
participate in the healthcare system's coordinated emergency 
preparedness program. If elected, the unified and integrated emergency 
preparedness program must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.

[[Page 64039]]

    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

0
32. Add Sec.  485.920 to read as follows:


Sec.  485.920  Condition of participation: Emergency preparedness.

    The Community Mental Health Center (CMHC) must comply with all 
applicable Federal, State, and local 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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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 on-duty staff and sheltered 
clients in the CMHC's care during and after an emergency. If on-duty 
staff and sheltered clients are relocated during the emergency, the 
CMHC must document the specific name and location of the receiving 
facility or other location.
    (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 
secures and maintains the availability of records.
    (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 maintain 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 Federal, 
State, and local laws 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 maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release client 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (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 is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program 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 demonstrate staff knowledge of emergency 
procedures. Thereafter, the CMHC must provide emergency preparedness 
training at least annually.
    (2) Testing. The CMHC must conduct exercises to test the emergency 
plan at least annually. The CMHC must:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. 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-based or individual, facility-based 
full-scale exercise for 1 year following the onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes a group discussion led by a 
facilitator,

[[Page 64040]]

using a narrated, clinically-relevant emergency scenario, and a set of 
problem statements, directed messages, or prepared questions designed 
to challenge an emergency plan.
    (iii) 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.
    (e) Integrated healthcare systems. If a CMHC is part of a 
healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the CMHC may choose to participate in 
the healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program must 
do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

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

0
33. 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
34. Add Sec.  486.360 to read as follows:


Sec.  486.360  Condition for Coverage: Emergency preparedness.

    The Organ Procurement Organization (OPO) must comply with all 
applicable Federal, State, and local 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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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 on-duty staff during and 
after an emergency. If on-duty staff is relocated during the emergency, 
the OPO must document the specific name and location of the receiving 
facility or other location.
    (2) A system of medical documentation that preserves potential and 
actual donor information, protects confidentiality of potential and 
actual donor information, and secures and maintains the availability of 
records.
    (c) Communication plan. The OPO must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws 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 is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program 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) Demonstrate staff 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

[[Page 64041]]

tabletop exercises, and emergency events, and revise the OPO's 
emergency plan, as needed.
    (e) Continuity of OPO operations during an emergency. Each OPO must 
have a plan to continue operations during an emergency.
    (1) The OPO must develop and maintain in the protocols with 
transplant programs required under Sec.  486.344(d), mutually agreed 
upon protocols that address the duties and responsibilities of the 
transplant program, the hospital in which the transplant program is 
operated, and the OPO during an emergency.
    (2) The OPO must have the capability to continue its operation from 
an alternate location during an emergency. The OPO could either have:
    (i) An agreement with one or more other OPOs to provide essential 
organ procurement services to all or a portion of its DSA in the event 
the OPO cannot provide those services during an emergency;
    (ii) If the OPO has more than one location, an alternate location 
from which the OPO could conduct its operation; or
    (iii) A plan to relocate to another location as part of its 
emergency plan as required by paragraph (a) of this section.
    (f) Integrated healthcare systems. If an OPO is part of a 
healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the OPO may choose to participate in 
the healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program must 
do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES

0
35. 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
36. Amend Sec.  491.6 by removing paragraph (c).

0
37. Add Sec.  491.12 to read as follows:


Sec.  491.12  Emergency preparedness.

    The Rural Health Clinic/Federally Qualified Health Center (RHC/
FQHC) must comply with all applicable Federal, State, and local 
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 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 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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation, including documentation of the RHC/FQHC's efforts 
to contact such officials and, when applicable, of its participation in 
collaborative and cooperative planning efforts.
    (b) Policies and procedures. The RHC/FQHC must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least annually. At a minimum, the policies 
and procedures must address the following:
    (1) Safe evacuation from the RHC/FQHC, which includes appropriate 
placement of exit signs; staff responsibilities and needs of the 
patients.
    (2) A means to shelter in place for patients, staff, and volunteers 
who remain in the facility.
    (3) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (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 Federal, 
State, and local laws 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

[[Page 64042]]

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 is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program 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) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The RHC/FQHC must conduct exercises to test the 
emergency plan at least annually. The RHC/FQHC must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. 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-based or individual, 
facility-based full-scale exercise for 1 year following the onset of 
the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) 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.
    (e) Integrated healthcare systems. If a RHC/FQHC is part of a 
healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the RHC/FQHC may choose to participate 
in the healthcare system's coordinated emergency preparedness program. 
If elected, the unified and integrated emergency preparedness program 
must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan, and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

PART 494--CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE 
FACILITIES

0
38. 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
39. Amend Sec.  494.60 by removing paragraph (d) and redesignating 
paragraph (e) as paragraph (d).

0
40. 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, 
State, and local 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 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 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 cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain 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 confirm that the agency is aware of the dialysis 
facility's needs in the event of an emergency.
    (b) Policies and procedures. The dialysis facility must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least annually. These emergencies include, 
but are not limited to, fire, equipment or power failures, care-related 
emergencies, water supply interruption, and natural disasters likely to 
occur in the facility's geographic area. At a minimum, the policies and 
procedures must address the following:
    (1) A system to track the location of on-duty staff and sheltered 
patients in the dialysis facility's care during and after an emergency. 
If on-duty staff and

[[Page 64043]]

sheltered patients are relocated during the emergency, the dialysis 
facility must document the specific name and location of the receiving 
facility or other location.
    (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 
secures and maintains the availability of records.
    (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 maintain 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) How emergency medical system assistance can be obtained when 
needed.
    (9) A process by which the staff can confirm 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 Federal, State, and local laws 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 maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (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 is based on the emergency plan set 
forth in paragraph (a) of this section, risk assessment at paragraph 
(a)(1) of this section, policies and procedures at paragraph (b) of 
this section, and the communication plan at paragraph (c) of this 
section. The training, testing, and patient orientation program must be 
evaluated and updated at least annually.
    (1) Training program. The dialysis facility 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. 
Staff training must:
    (iii) Demonstrate staff knowledge of emergency procedures, 
including informing patients of--
    (A) What to do;
    (B) Where to go, including instructions for occasions when the 
geographic area of the dialysis facility must be evacuated;
    (C) 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
    (D) How to disconnect themselves from the dialysis machine if an 
emergency occurs.
    (iv) Demonstrate that, at a minimum, its patient care staff 
maintains current CPR certification; and
    (v) Properly train its nursing staff in the use of emergency 
equipment and emergency drugs.
    (vi) Maintain documentation of the training.
    (2) Testing. The dialysis facility must conduct exercises to test 
the emergency plan at least annually. The dialysis facility must do all 
of the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If the dialysis facility experiences an actual natural 
or man-made emergency that requires activation of the emergency plan, 
the ESRD is exempt from engaging in a community-based or individual, 
facility-based full-scale exercise for 1 year following the onset of 
the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes 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.
    (iii) 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.
    (e) Integrated healthcare systems. If a dialysis facility is part 
of a healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the dialysis facility may choose to 
participate in the healthcare system's coordinated emergency 
preparedness program. If elected, the unified and integrated emergency 
preparedness program must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.

[[Page 64044]]

    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for 
each separately certified facility within the health system, utilizing 
an all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

    Dated: March 9, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: April 6, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.

    Editorial Note: This document was received by the Office of the 
Federal Register for publication on September 1, 2016.

[FR Doc. 2016-21404 Filed 9-8-16; 4:15 pm]
BILLING CODE 4120-01-P