1. Emergency Preparedness Final Rule
CMS Emergency Preparedness Rule Arkansas Hospital Association Emergency Preparedness
Emergency Preparedness Final Rule
Now and Then
Caecilia Blondiaux
Division of Acute Care Services
Centers for Medicare & Medicaid Services

2. Final Rule Published September 16, 2016
Applies to all 17 provider and supplier types
Implementation date November 15, 2017
Compliance required for participation in Medicare
Emergency Preparedness is one new CoP/CfC of many already required
Appendix Z- State Operations Manual (updated in February 2019)

3. Four Provisions for All Provider Types
Risk Assessment and Planning
Policies and Procedures
Communication Plan
Training and Testing
Emergency Preparedness Program
RISK ASSESSMENT AND PLANNING – all providers must develop an emergency plan using all hazards approach, plan and identify in advance essential functions and who is responsible in a crisis.
POLICIES AND PROCEDURES – developed based on the plan (e.g. medical documentation, evacuation or shelter and place)
COMMUNICATION PLAN – alternate means of communication, provide info to local authorities sharing medical info, and providing occupancy information and ability to provide assistance to other facilities in the community.
TRAINING AND TESTING PROGRAM – train staff and test the plan through drills 8

4. Risk Assessment and Planning
Develop an emergency plan based on a risk assessment.
Perform risk assessment using an “all-hazards” approach, focusing on capacities and capabilities.
Update emergency plan at least annually.
(Note: CMS is not specifying a specific risk assessment to be used- i.e. HVA, Integrate EM System Risk Assessment) 9

5. All-Hazards Approach:
An all-hazards approach is an integrated approach to emergency preparedness planning that focuses on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters, including internal emergencies and a man-made emergency (or both) or natural disaster. This approach is specific to the location of the provider or supplier and considers the particular type 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.
2019 Update added “emerging infectious diseases” to the definition. 7

6. What do we mean by “Emerging Infectious Diseases”?
We are not specifying the type of infectious diseases to consider or care-related emergencies which are as a result of infectious diseases. Adding EID’s was specifically to ensure that facilities consider having infection prevention personnel at the table when it comes to planning and development of their emergency preparedness program.
The proposed and final rule spoke to Ebola and H1N1 and subsequently we dealt with the Zika virus, therefore CMS found it prudent to ensure that EIDs are included in the definition of all-hazards.
Some examples may include, but are not limited to:
Hazardous Waste
Bioterrorism
Pandemic Flu
Highly Communicable Diseases (such as Ebola)
. Some emerging infectious diseases may include, but are not limited to:
H7N9 Pandemic Influenza (“bird flu”) ,589 cases and 616 deaths in China
Middle East Respiratory Syndrome (MERS) ,143 cases in 27 countries, and 750 deaths
H1N1 (2009) Pandemic Influenza (“swine flu”) More than 284,000 deaths worldwide
H5N1 Pandemic Influenza (“bird flu”) 2003– cases and 449 deaths worldwide
Severe Acute Respiratory Syndrome (SARS) ,096 cases and 774 deaths worldwide
Sources: Kaiser Family Foundation, “The U.S. Government and Global Health Security,” 2016; World Health Organization, “Middle East respiratory syndrome coronavirus (MERS-CoV),” 2018.

7. Policies and Procedures
Develop and implement policies and procedures based on the emergency plan and risk assessment.
Policies and procedures must address a range of issues including subsistence needs, evacuation plans, procedures for sheltering in place, tracking patients and staff during an emergency.
Review and update policies and procedures at least annually.
Policies and procedures must be based on the risk assessment and the emergency plan must address (highlights/full list in the regulations)
--provision of sub-sis-ten-ce needs, alternate energy sources, sewage and waste disposal, procedures for evacuating or sheltering in place
--system to track location of staff and patients (accurate, readily available, shareable)
--safe evacuation considerations –Care and treatment needs, transportation, ID evacuation location
--means to shelter in place – consider ability of building to survive a disaster and proactive steps that can be taken prior to an emergency
--system to preserve medical documentation (ensures confidentiality in compliance with HIPAA)
--use of volunteers and role of State and Federal Health Officials (suggest use of Medical Reserve Cops – ensure members are screened and trained in advance)
--Arrangements with other providers to receive patients in the event of limitation or cessation of operations as well as a method for sharing medical documentation with the receiving provider. 10

8. Communication Plan
Develop a communication plan that complies with both Federal and State laws.
Coordinate patient care within the facility, across health care providers, and with state and local public health departments and emergency management systems.
Review and update plan annually.
Plan must include
--names and contact info for physicians, other hospitals, volunteers, State and local EP officials
--Primary and alternate means of communicating with staff and EP officials and emergency management agencies (alternate means cell phones, satellite systems)
--method to share medical records and patient information including general condition and location
--method to share information regarding occupancy, needs and the hospital’s ability to provide assistance (authority or incident command) 11

9. Training and Testing Program
Develop and maintain training and testing programs, including initial training in policies and procedures.
Demonstrate knowledge of emergency procedures and provide training at least annually.
Conduct drills and exercises to test the emergency plan.
--Full-Scale Exercise:
For purposes of the requirement for a community-based full-scale exercise, we expect facilities to simulate an anticipated response to an emergency involving their actual operations and the community. This would involve the creation of scenarios, the engagement and education of personnel, and mock patients/victims. In addition, this would include the involvement of other providers, suppliers, and community emergency response agencies. Collaboration and engagement with community partners should be conducted not only to meet this requirement, but for purposes of determining each partners role and capabilities in an emergency situation.
The intention of this requirement is to not only assess the feasibility of a provider's emergency plan through testing, but also to encourage providers to become engaged in their community and promote a more coordinated response within the facility, across health care providers, and with State and local public health departments and emergency systems.
--When a community-based full-scale exercise is not available: We understand that participation in a community based full-scale exercise may not always be feasible or readily accessible. Therefore, if a community-based full-scale exercise is not feasible, the requirement does provide providers with the flexibility to conduct a testing exercise that is based on the individual facility. 12

10. 1135 Waivers
SCOPE: Federal Requirements only, not state licensure. Determine: Scope and severity of event with specific focus on health care infrastructure; Are there unmet needs for health care providers? Can these unmet needs be resolved within our current regulatory authority?
PURPOSE: Allow reimbursement during an emergency or disaster even if providers can’t comply with certain requirements that would under normal circumstances bar Medicare, Medicaid or CHIP payment
DURATION: End no later than the termination of the emergency period, or 60 days from the date the waiver or modification is first published unless the Secretary of HHS extends the waiver by notice for additional periods of up to 60 days, up to the end of the emergency period.

11. 1135 Waivers- DO NOT
Waivers DO NOT:
1135 waivers are not a grant or financial assistance program
Do not allow reimbursement for services otherwise not covered
Do not allow individuals to be eligible for Medicare who otherwise would not be eligible
Should NOT impact any response decisions, such as evacuations.
Do not last forever. And appropriateness may fade as time goes on.

12. Examples of 1135 Waiver Authorities
1135 Waivers- Examples
Conditions of Participation: For instance, CAHs require 25-bed limit and Average Patient stays of less than 96-hours or SNFs- 3-day prior hospitalization for SNF Patients
Licensure for Physicians or others to provide services in affected state
Emergency Medical Treatment and Labor Act (EMTALA): For instance, Request to setup Alternate Screening Locations
Stark Self-Referral Sanctions
Medicare Advantage out of network providers
HIPAA (Based on OCR determination)
Examples of 1135 Waiver Authorities

13. 1135 Waiver Review Process
Within defined Emergency Area?
Is there an actual need?
Will Regulatory relief requested actually address stated need?
Can this be resolved within current regulations?
Should we consider individual or blanket waiver?
What is the expected duration?

14. The Final Rule and 1135 Waivers
To be compliant with the requirement under the Emergency Preparedness Final Rule, you’ll need to have a policy and procedure for addressing your facility’s awareness of the 1135 Waiver Process.
There is no specific form or document template.
Some elements that could be considered and reflected (but not limited to) in the policies and procedures.
Having an 1135 waiver on file is NOT possible since 1135 waivers are event & geographically specific & time limited.
For more information visit: Quality, Safety & Oversight Group 1135 Waiver Resource Website at:

15. What has been completed?
In September, 2017, the surveyor training for emergency preparedness requirements was launched. Available at
Training through the Integrated Surveyor Training Website is available for providers/suppliers.
Facilities started being surveyed after November 15th, 2017 in conjunction with scheduled surveys and survey cycles based on their provider types.

16. Where are we now? Upcoming Efforts
Updated Appendix Z in February 2019 to include emerging infectious diseases; corrections to HHA citations; clarifications to portable use generators and alternate source power
CMS will continue to review and analyze progress of compliance among providers suppliers affected
CMS will engage with different partners related to the potential for additional resources in challenge areas of compliance
Additional training as needed with surveyors

17. The Website
Providers and Suppliers should refer to the resources on the CMS website for assistance in developing emergency preparedness plans.
The website also provides important links to additional resources and organizations who can assist. 19

18. ASPR’s Technical Resources, Assistance Center, and Information Exchange
ASPR TRACIE was developed as a healthcare emergency preparedness information gateway to address the need for:
Enhanced technical assistance
Comprehensive, one-stop, national knowledge center for healthcare system preparedness
Multiple ways to efficiently share and receive (push-pull) information between various entities, including peer-to-peer
Leveraging and better integrating support (force multiplier)
Self-service collection of audience-tailored materials
Subject-specific, SME-reviewed “Topic Collections”
Unpublished and SME peer-reviewed materials highlighting real-life tools and experiences
Personalized support and responses to requests for information and technical assistance
Accessible by toll-free number ( TRACIE), or web form (ASPRtracie.hhs.gov)
Area for password-protected discussion among vetted users in near real-time
Ability to support chats and the peer-to-peer exchange of user-developed templates, plans, and other materials
ASPR’s Technical Resources Assistance Center & Information Exchange (TRACIE) is a healthcare emergency preparedness information gateway that ensures all stakeholders—at the federal, state, local, tribal, and territorial government levels and non- and for-profit organizations—have access to information and resources to improve preparedness, response, recovery, and mitigation efforts. Each of the three domains (TR, AC, IE) provides users with unique support. ASPR TRACIE launched on September 30, 2015.
Nearly 600 TA received through ASPR TRACIE (or 24%) has been related to the CMS EP Rule. ASPR TRACIE has a number of guidance documents, plans, tools, and templates to assist facilities complying with the CMS EP Rule. Visit asprtracie.hhs.gov/cmsrule for additional information.
ASPR developed TRACIE to:
Ensure all partners – at the federal, state, local, non-profit and for-profit levels – have access to information and resources throughout the continuum of tiers of preparedness, response, and recovery, ASPR has begun developing a Technical Resources Assistance Center and Information Exchange (TRACIE). 
Provide stakeholders access to information, share promising practices, and identify and remedy knowledge gaps for private-citizens, as well as local, state, and federal officials. 
Identify and remedy knowledge gaps, and assist with unique and complex technical assistance to states, healthcare coalitions, communities, and involved individuals.
Leverage resources to better integrate support and will serve as a force multiplier by improving information sharing and minimizing duplication of effort.
We continues to add new features to our website to ensure optimal user experience. We continuously seek feedback from stakeholders on how to improve our processes and usability.
Technical Resources
Two main components:
Resource Library containing published and grey literature and searchable by keywords.
The ASPR TRACIE Technical Resources Library contains the complete National Library of Medicine’s Disaster Lit database of over 10,000 records describing no-cost, online disaster medicine and public health documents and other resources selected from over 800 organizations.
Topic Collections- currently have 62 topics; creates a tailored experience for users; list is functional based and goes beyond capabilities.
Users can also rate and comment on resources in the Topic Collections and ASPR TRACIE Resource Library
Assistance Center
Person to person direct assistance from TRACIE TA Specialists
TA Specialists have a background in healthcare and public health preparedness
Open Monday-Friday, 9am-5pm ET (excluding Federal holidays), at TRACIE or
Information Exchange
Peer to peer online discussion board with near real time sharing
User controlled and password protected
Allows private rooms where users can discuss ideas and share resources with a select group of colleagues.
TRACIE TA Specialists will moderate and monitor conversations to identify potential resources to share with others/ request to be part of Resource Library
TA Specialists will monitor all the domains to see if there are any “trending” or unusual topics/ issues that are being searched in the Resource Library, asked through the Assistance Center, and/or talked about in the Information Exchange. Will notify ASPR of any unusual spikes in information requests.
How else can stakeholders be involved?
Apply and nominate your peers to serve in the ASPR TRACIE SME Cadre.
Send us useful plans, tools, templates, and other resources to be considered for inclusion in the ASPR TRACIE Resource Library and/or Topic Collections.
Give us your feedback! Take the site feedback survey (available at the bottom of every page on the website) or contact us with your feedback, recommendations, and comments on any aspect of ASPR TRACIE.
ASPR TRACIE Stats as of October 2017 (for updated stats and infographic, contact ASPR TRACIE)
Since ASPR TRACIE launched on September 30, 2015:
The site has an average of 5,687 visitors per month
The Assistance Center maintains a 97% user satisfaction rating
The Information Exchange has over 3,700 members
Our distribution list reaches over 150,000 members (with additional distribution by our partners such as ASTHO, NACCHO, Joint Commission, NLM)
We’ve created 50 comprehensive Topic Collections, with 13 additional TCs on the way
We’ve provided over 2500 responses to technical assistance on topics such as the CMS rule, Zika, Ebola and other Infectious Disease work plans, patient movement
We’ve also worked with more than 500 SMEs to develop the topic collections, answer requests for assistance, and develop new resources such as tip sheets on topics such as CMS, Zika, Hurricanes, and retaining staff after a disaster 9

19. Regional Office Contacts
Addresses for CMS Regional Offices:
(Atlanta RO):  Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee;
(Dallas RO): Arkansas, Louisiana, New Mexico, Oklahoma, and Texas
(Northeast Consortium): Delaware, District of Columbia,  Maryland, Pennsylvania, Virginia, West Virginia, New York, New Jersey, Puerto Rico, Virgin Islands, Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont
(Midwest Consortium): Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin, Iowa, Kansas, Missouri, and Nebraska
(Western Consortium): Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming, Alaska, Idaho, Oregon, Washington, Arizona, California, Hawaii, Nevada, and the Pacific Territories.

20. Contact Information for CMS
Regional Office and State Survey Agency Contact Lists: (We recommend seeking their input first).
General Mailbox for Policy Inquiries:
CMS Website:

21. Thank you! SCGEmergencyPrep@cms.hhs.gov
Any follow up questions can be ed to SCG Emergency cms.hhs.gov. I’ll turn it over to