CMS Issues Interpretive Guidance for the  Emergency Preparedness Rule

CMS Issues Interpretive Guidance for the Emergency Preparedness Rule

The Center for Medicare and Medicaid Services (CMS) has issued an advanced copy of interpretive guidelines and survey procedures for the new emergency preparedness rule. The 72 page document is a near final draft necessary to guide providers and suppliers in meeting the new emergency preparedness Conditions of Participation (CoP) and Conditions of Coverage (CfC) that become enforceable for 17 healthcare provider and supplier types November 15, 2017.

Officially, the document is titled the State Operations Manual: Appendix Z- Emergency Preparedness for All Provider and Certified Supplier Types, Interpretive Guidance, but is more commonly called the State Operations Manual or simply interpretive guidance.

Survey, Certification, and Interpretation

To qualify for Medicare and Medicaid certification and reimbursement, providers and suppliers of health services must comply with minimum health and safety standards called CoPs and CfCs. Collectively, we'll refer to CoPs and CfCs as  requirements for participation. The emergency preparedness rule contains new requirements for participation applicable to 17 healthcare provider and supplier types.

To demonstrate compliance with their requirements for participation, providers and suppliers are surveyed by State Survey Agencies (SA), which are generally state health departments, deemed accreditation organizations (AO), such as The Joint Commission, or CMS Regional Offices (RO).

CMS Survey and Certification for Emergency Preparedness Rule

Note that, regardless of the surveyor, the Survey and Certification Process is the carried out under the direction of CMS within the scope of the applicable Code of Federal Regulations. And the minimum expectations that CMS expects surveyors to hold providers and suppliers to are outlined in detail in the State Operations Manual. Essentially, that State Operations Manual is CMS' interpretation of what an applicable regulation means and how compliance with it will be determined.

Hence, the great interest in the interpretive guidance for the emergency preparedness rule.

You see, without a satisfactory survey, providers and suppliers risk not being eligible to receive a Certification of Compliance – the Certification of Compliance necessary to do business with the Nation's largest insurance carrier. Yes, Medicare only covers (pays for) care provided in facilities that are certified as compliant with their requirements for participation.

Emergency Preparedness Interpretive Guidance

CMS Emergency Preparedness Rule Interpretive Guidance Cover Image

Per CMS, because the requirements for participation for each specific provider and supplier share a majority of standard provisions, they developed a new appendix for all – Appendix Z.  CMS believes that locating all requirements in a single document provides for more consistent interpretive guidance and survey procedures.

In support of their shared standards mantra, CMS states that "[t]he new emergency preparedness Final Rule is based primarily off the hospital emergency preparedness Condition of Participation (CoP) as a general guide for the remaining providers and suppliers, then tailored based to address the differences and or unique needs of the other providers and suppliers (e.g. inpatient versus out-patient providers)."

Further, the emergency preparedness appendix has been "developed to support the adoption of a standard all- hazards emergency preparedness program for all certified providers and suppliers while similarly including appropriate adjustments to address the unique differences of the other providers and suppliers and their patients."

The specific requirements for participation covered in the document are:

CMS Emergency Preparedness Rule Cover Image

The  “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers” Final Rule (81 FR 63860, Sept. 16, 2016) (“Final Rule”) establishes national emergency preparedness requirements for participating providers and certified suppliers to plan adequately for both natural and man-made disasters, and coordinate with Federal, state, tribal, regional and local emergency preparedness systems.

The rule took effect on November 15, 2016 and becomes enforceable November 15, 2017 through the survey and certification process. CMS has not indicated a date of publication for the final State Operations Manual.

Stay tuned for a detailed analysis of the final State Operations Manual when it publishes final.

Reminder: The Shot Over the Bow

As I wrote about a few weeks ago, (CMS to Providers: Don't Wait On Us!), in response to repeated questions from providers asking whether they will be expected to have completed the "exercises" per the training and testing requirements in each standard (d) of the Final Rule, by the implementation date, CMS' Director of the Survey and Certification Group issued a memorandum March 24th, Information to Assist Providers and Suppliers in Meeting the New Training and Testing Requirements of the Emergency Preparedness Requirements for Medicare & Medicaid Participating Providers and Suppliers Final Rule.

The answer is yes, and CMS is not just referring to the training and testing requirements. The memo makes it clear that beginning November 15, 2017, all affected providers and suppliers must meet all applicable requirements of the rule, and that waiting for interpretive guidance is not a good strategy. "We realize that some providers and suppliers are waiting for the release of the interpretive guidance to begin planning these exercises, but that is not necessary nor is it advised," states the memo. "Providers and suppliers that are found to have not completed these exercises, or any other requirements of the Final Rule upon their survey, will be cited for non-compliance."

And if you are a healthcare coalition leader who has providers and suppliers suddenly coming out of the woodwork and know your organization's not ready to engage them and meet their needs, consider hosting one of our Healthcare Coalition Development Workshop. They are a great shared cost, shared effort opportunity for coalition leaders from a State or  a multi-state region. The next 'open registration' opportunity is hosted by the SouthEast Texas Regional Advisory Council (SETRAC) on Galveston Island in Texas, October 9 & 10.


Karl Schmitt, MPA

Karl Schmitt, MPA

Karl is the Passionate Founder & CEO of bParati. He is on a mission to build a national network of effective, sustainable healthcare coalitions. More...

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