Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers
Federal RegisterSep 16, 2016
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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.
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
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 (§ 482.15)
1. Risk Assessment and Emergency Plan (§ 482.15(a))
2. Policies and Procedures (§ 482.15(b)
3. Communication Plan (§ 482.15(c)
4. Training and Testing (§ 482.15(d)
5. Emergency Fuel and Generator Testing (§ 482.15(e)
D. Emergency Preparedness Regulations for Religious Nonmedical Health Care Institutions (RNHCIs) (§ 403.748)
E. Emergency Preparedness Regulations for Ambulatory Surgical Centers (ASCs) (§ 416.54)
F. Emergency Preparedness Regulations for Hospices (§ 418.113)
G. Emergency Preparedness Regulations for Psychiatric Residential Treatment Facilities (PRTFs) (§ 441.184)
H. Emergency Preparedness Regulations for Programs of All-Inclusive Care for the Elderly (PACE) (§ 460.84)
I. Emergency Preparedness Regulations for Transplant Centers (§ 482.78)
J. Emergency Preparedness Regulations for Long-Term Care (LTC) Facilities (§ 483.73)
K. Emergency Preparedness Regulations for Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICF/IID) (§ 483.475)
L. Emergency Preparedness Regulations for Home Health Agencies (HHAs) (§ 484.22)
M. Emergency Preparedness Regulations for Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§ 485.68)
N. Emergency Preparedness Regulations for Critical Access Hospitals (CAHs) (§ 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) (§ 485.727)
P. Emergency Preparedness Regulations for Community Mental Health Centers (CMHCs) (§ 485.920)
Q. Emergency Preparedness Regulations for Organ Procurement Organizations (OPOs) (§ 486.360)
R. Emergency Preparedness Regulations for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (§ 491.12)
S. Emergency Preparedness Regulations for End-Stage Renal Disease (ESRD) Facilities (§ 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
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.
• 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
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.
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 § 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
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
esarvhp@hhs.gov
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
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
of the National Institute for Environmental Health Sciences (NIEHS) for more information on integrating worker health and safety protections into emergency planning.
Response:
While we believe that providers should prioritize the health and safety of their healthcare workers during an emergency, we do not believe that it is appropriate to include detailed requirements within this regulation. As we have previously stated, the regulation is not intended to be overly prescriptive. Therefore, providers have the discretion to establish policies and procedures in their emergency preparedness plans that meet the minimum requirements in this regulation and that are tailored to the specific needs and circumstances of the facility. We note that providers should continue to comply with pertinent federal, state, or local laws regarding the protection of healthcare workers in the workplace.
While it is not within the scope of this rule to address OSHA, NIOSH, or NIEHS work place regulations, we encourage providers and suppliers to consider developing policies and procedures to protect healthcare workers during an emergency. We refer readers to the following list of resources to aid providers and suppliers in the formulation of such policies and procedures:
•
https://www.osha.gov/SLTC/emergencypreparedness/
•
http://www.cdc.gov/niosh/topics/emergency.html
•
http://www.niehs.nih.gov/health/topics/population/occupational/index.cfm
Comment:
A few commenters noted that while section 1135 of the Act waives certain Conditions of Participation (CoPs) during a public health emergency, there is no authority to waive the Conditions for Payment (CfPs). The commenters recommended that the Secretary thoroughly review the requirements under the CoPs and the CfPs and seek authority from Congress to waive additional requirements under the CfPs that are burdensome and that affect timely access to care during emergencies.
Response:
While we appreciate the concerns of the commenters, these comments are outside the scope of this rule.
1. Integrated Health Systems
In the proposed rule, we proposed that for each separately certified healthcare facility to have an emergency preparedness program that includes an emergency plan, based on a risk assessment that utilizes an all hazards approach, policies and procedures, a communication plan, and a training program.
Comment:
We received a few comments that suggested we allow integrated health systems to have one coordinated emergency preparedness program for the entire system.
Commenters explained that an integrated health system could be comprised of two nearby hospitals, a LTC facility, a HHA, and a hospice. The commenters stated that under our proposed regulation, each entity would need to develop an individual emergency preparedness program in order to be in compliance. Commenters proposed that we allow for the development of one universal emergency preparedness program that encompasses one community-based risk assessment, separate facility-based risk assessments, integrated policies and procedures that meet the requirements for each facility, and coordinated communication plans, training and testing. They noted that allowing for a coordinated emergency preparedness program would ultimately reduce the burden placed on the individual facilities and provide for a more coordinated response during an emergency.
Response:
We appreciate the comments received on this issue. We agree that allowing integrated health systems to have a coordinated emergency preparedness program is in the best interest of the facilities and patients that comprise a health system. Therefore, we are revising the proposed requirements by adding a separate standard to the provisions applicable to each provider and supplier type. This separate standard will allow any separately certified healthcare facility that operates within a healthcare system to elect to be a part of the healthcare system's unified emergency preparedness program. If a healthcare system elects to have a unified emergency preparedness program, this integrated program must demonstrate that each separately certified facility within the system actively participated in the development of the program. In addition, each separately certified facility must be capable of demonstrating that they can effectively implement the emergency preparedness program and demonstrate compliance with its requirements at the facility level.
As always, each facility will be surveyed individually and will need to demonstrate compliance. Therefore, the unified program will also need to be developed and maintained in a manner that takes into account the unique circumstances, patient populations, and services offered for each facility within the system. For example, for a unified plan covering both a hospital and a LTC facility, the emergency plan must account for the residents in the LTC facility as well as those patients within a hospital, while taking into consideration the difference in services that are provided at a LTC facility and a hospital. In addition, the healthcare system will need to take into account the resources each facility within the system has and any state laws that the facility must adhere to. The unified emergency preparedness program must also include a documented community-based risk assessment and an individual facility-based risk assessment for each separately certified facility within the health system, both utilizing an all-hazards approach. The unified program must also include integrated policies and procedures that meet the emergency preparedness requirements specific to each provider type as set forth in their individual set of regulations. Lastly, the unified program must have a coordinated communication plan and training and testing program. We believe that this approach will allow a healthcare system to spread the cost associated with training and offer a financial advantage to each of the facilities within a system. In addition, we believe that, in some cases this approach will provide flexibility and could potentially result in a more coordinated response during an emergency that will enable a more successful outcome.
2. Requests for Technical Assistance and Funding
The December 2013 proposed rule included an appendix of the numerous resources and documents used to develop the proposed rule. Specifically, the appendix to the proposed rule included helpful reports, toolkits, and samples from multiple government agencies such as ASPR, the CDC, FEMA, HRSA, AHRQ, and the Institute of Medicine (See Appendix A, 78 FR 79198). In response to our proposed rule, we received numerous comments requesting that we provide facilities with increased funding and technical assistance to implement our proposed regulations.
Comment:
A few commenters appreciated the resources that we provided in the proposed rule, but expressed concerns that, despite the resources referenced in the regulation, busy and resource-constrained facilities will not have a simple and organized way to access technical assistance and
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
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
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.
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®) 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
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 (§ 482.15)
Our proposed hospital regulatory scheme was the basis for all other
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 (§ 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 §§ 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 §§ 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 § 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 § 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 § 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 § 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 § 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
pharmacological dependency. According to the section 2802 of the PHS Act (42 U.S.C. 300hh-1) as added by Pandemic and All-Hazards Preparedness Act (PAHPA) in 2006, in “at-risk individuals” means children, pregnant women, senior citizens and other individuals who have special needs in the event of a public health emergency as determined by the Secretary. In 2013, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) amended the PHS Act (
http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf
) and added that consideration of the public health and medical needs of “at-risk individuals” includes taking into account the unique needs and considerations of individuals with disabilities. The National Response Framework (NRF), the primary federal document guiding how the country responds to all types of disasters and emergencies, includes in its description of “at-risk individuals” children, individuals with disabilities and others with access and functional needs; those from religious, racial and ethnically diverse backgrounds; and people with limited English proficiency. We have included additional examples of at-risk populations, including definitions from both PHS Act and NRF and have expanded the definition to include examples used in the healthcare industry. We have stated that the patient population may not be limited to just persons at-risk but may include, for example, descriptions of patient populations unique to their geographical areas, such as CMHCs and PRTFs. The definition of at-risk populations provided in the regulation text is to include all of the populations discussed in the NRF and PHS Act definitions and are defined within the individual providers and suppliers included in this regulation.
We also proposed at § 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 § 482.15(a)(3) that all hospitals include delegations and succession planning in their emergency plan to ensure that the lines of authority during an emergency are clear and that the plan is implemented promptly and appropriately.
Finally, at § 482.15(a)(4), we 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
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
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® 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 § 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
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 (§ 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 § 482.15 by adding the term “local” to clarify that hospitals must also coordinate with local emergency preparedness systems.
• Revising § 482.15(a)(4) to remove the word “ensuring” and replacing the word “ensure” with “maintain.”
2. Policies and Procedures (§ 482.15(b))
We proposed at § 482.15(b) that a hospital be required to develop and implement emergency preparedness policies and procedures based on the emergency plan proposed at § 482.15(a), the risk assessment proposed at § 482.15(a)(1), and the communication plan proposed at § 482.15(c). We proposed that these policies and procedures be reviewed and updated at least annually.
We proposed at § 482.15(b)(1) that a hospital's policies and procedures would have to address the provision of subsistence needs for staff and patients, whether they evacuated or sheltered in place, including, but not limited to, at § 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 § 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 § 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 § 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 § 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
external sources of assistance. We proposed at § 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 § 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 § 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 § 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 § 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 § 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
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 § 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 § 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 § 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 § 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, § 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.
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
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