Late this past week CMS published an “Advanced Copy” of the Interpretive Guidelines (IGs) for the Emergency Preparedness Rule finalized in the Fall of 2016. This 72-page document will guide State Survey Agencies as to how to determine compliance of the 17 affected providers after the November 15, 2017, deadline.

This is an “Advanced Copy” meaning it is still a draft and can change before being finalized when it is integrated into the State Operations Manual.

Overview Analysis

I was hoping to say after reviewing the Interpretive Guidelines (IG) that I had fewer questions, but I am not exactly sure that is the case.  While it does clarify some things it creates questions for others.  So here is an overview analysis of the IG Document, and there will be future posts going into further detail on specific topics (i.e. make sure you sign-up for our mailing list to get notified when new content is posted).

Overall, the language mirrors the CoPs and the fully published 651-page rule.  The IG document addresses [Facilities] as a whole with callouts for specific provider type for variations.  Throughout the document, there is increased instruction to Surveyors to interview both staff and facility leadership.  Interview topics range from both knowledge of policy, procedure, and response, but for facility leadership, it also includes the methodology used to develop the plan and documents.  Additionally, CMS repeatedly states [Facilities] have flexibility in how they reach compliance and how they structure policies and procedures.

The IGs clearly establish the need for an annual process of review and management of the comprehensive emergency management program, with the Risk Analysis and the Emergency Management Plan being at the core.  To meet the definition of “comprehensive” set forth in the IG, the provider must plan for multiple events/threats through an all-hazards methodology.   Additionally, it must be developed in an all-inclusive nature with key stakeholders across the organization.  Facility leadership needs to be involved and/or fully educated to the planning methodologies so they can easily speak it to it during a survey.

In accordance with best practice in emergency preparedness CMS expects the Risk Analysis to drive the direction of the emergency preparedness policy.  The IGs indicate input from two sets of risk analysis, one that is facility based and one that is community-based  The risk assessment must be customized to the facility and the community in which the facility is located.  Facilities that have residents must include missing residents as one of their risks.  During a CMS survey Facility Leadership will be expected to speak to the top risks and how they are determined.

As the planning process moves forward the IG calls out the importance of core tenants of Continuity of Operations (COOP) and later differentiates it from Continuity of Service.  There will be key components of COOP like delegation of authority that surveyors could be looking for.

The IGs also call out specific guidance regarding evacuation, environmental management, transfer agreements, and several other key topics that may not warrant a full policy but will need to be addressed in the program overall.  There are some more subtle variations between inpatient and outpatient [Facilities}.  There is considerable discussion around communication and education of specific providers where the patient is somewhat independent from the provider such as Home Health and Dialysis.

If you are looking for clarifications around exercise, skip the definition page and jump to the E-039, where there is more realistic instruction on how to manage a “Full-Scale Exercise” (FSX) as more operational based exercise if a community FSX is not available.

I would be remiss if I did not bring up Integrated Health Care System, what is a little more than a paragraph in the CoP, brings 3 pages of IG guidance.  Successfully complying with this for large healthcare will require a large collaborative process with some significant documentation, and that is definitely going to warrant its own blog post.

All in all, the IGs are a start and CMS is marching towards the November 15 deadline.  I do believe there is more clarification needed and maybe even more content.  As promised, over the next couple of weeks CMS will be integrating this into the State Operations Manual, I will be sending my contacts at CMS some comments that will hopefully be considered.


Crisis Focus, LLC has focused expertise in healthcare emergency management, including CMS compliance. Please visit Crisis Focus’ CMS Emergency Preparedness resource page or contact us for more information.