81 FR 63859 - Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 180 (September 16, 2016)
Page Range
63859-64044
FR Document
2016-21404
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.
Federal Register, Volume 81 Issue 180 (Friday, September 16, 2016)
[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Rules and Regulations]
[Pages 63859-64044]
From the Federal Register Online [www.thefederalregister.org]
[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.
[[Page 63863]]
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.htmlhttp://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.thefederalregister.org/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.htmlhttp://www.dhs.gov/government-emergency-telecommunications-service-getshttp://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.pdfhttp://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
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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.