Newsletter Article

Jun 1, 2021

Appendix Z Update Simplified

CMS article summarized by Cindy Melanson, Senior Regulatory Advisor and Theresa Griffin-Rossi, Program Development Advisor

On March 26, 2021 CMS, the Director of Quality, Safety & Oversight Group released the memorandum “Updated Guidance for Emergency Preparedness – Appendix Z of the State Operations Manual (SOM).”   The memorandum, effective immediately, included interpretive guidance on the regulatory revisions put forth in Burden Reduction Final Rule (CMS 3346-F) and expanded guidance related to Emerging Infectious Diseases (EIDs).

A summary of regulatory revisions in response to the Burden Reduction Final Rule published September 30, 2019 are as follows:

  • Review of the patient care policies by the clinic’s advisory group that includes, at a minimum a physician, and physician’s assistant or nurse practitioner, and one person who is not a member of the clinic staff is now a biennial review as opposed to an annual review.
  • RHCs are required to conduct a biennial program evaluation as opposed to an annual program evaluation.
  • The clinic’s Emergency Preparedness (EP) plan needs to be reviewed and updated at least every 2 years as opposed to annually.
  • The clinic’s EP policies and procedures are reviewed and updated at a minimum at least every 2 years as opposed to annually.
  • The clinic’s EP communication plan is reviewed and updated, at a minimum at least every 2 year as opposed to annually.
  • The clinic’s EP training and testing program is reviewed and updated, at a minimum at least every 2 years as opposed to annually.
  • Clinics are required to only conduct one testing exercise on an annual basis, which may be either one community-based full-scale exercise, if available, or an individual facility-based functional exercise. The opposite years (every other year opposite of the full-scale exercises), clinics may choose the testing exercise of their choice, which can include either another full-scale, individual facility-based, a mock disaster drill (using mock patients), tabletop exercise or workshop which includes a facilitator.

A summary of the revisions in response to the Expanded Guidance to EIDs are as follows:


  • As clinics develop or revise their emergency preparedness plan, they should keep in mind that EID’s are a potential threat that can impact the operations and continuity of care within a healthcare setting.  Thus, CMS now requires the clinic’s risk assessment with an all-hazards approach include EIDs (i.e., Ebola, Zika, COVID-19, SARS, Pandemic Flu).
  • The Emergency Preparedness (EP) plan must encompass how the clinic will plan, coordinate and respond to a localized and widespread EIDs and pandemics.
  • Planning should include a process to evaluate the clinic’s needs based on the specific characteristics of an EID that includes, but is not limited to:
      • Influx in need of PPE
      • Considerations for screening patients and visitors, which may also include testing considerations for staff, visitors, and patients for infectious diseases.
      • Physical environment, including but not limited to changes needed for distancing, isolation, or capacity/surge.
  • Clinics should ensure their EP programs are aligned with their State and local emergency plans/pandemic plans.
  • The EP plan must be in writing.
  • Clinics are encouraged to have policies that address their ability to respond to a surge in patients. As required, these policies and procedures must be aligned with a facility’s risk assessment and should include planning for EIDs.  For example, clinics are encouraged to consider development of policies and procedures that could be implemented during an emergency to reduce non-essential healthcare visits and slow surge within the facility, such as:
      • Instructing patients to use available advice lines, patient portals, and/or on-line self-assessment tools.
      • Call options to speak to an office/clinic staff and identification of staff to conduct telephonic interactions with patients.
      • Development of protocols so that staff can triage and assess patients quickly.
      • Determine algorithms to identify which patients can be managed by telephone and advised to stay home, and which patients will need to be sent for emergency care or come to your facility.
  • EP testing exercises must be reflective of the hazards listed in the clinic’s risk assessment.   For example, if the clinic is located in an area that is prone to wildfires and conducts a fire drill, fire must be listed as a hazard on the risk assessment (e.g., wildfires) as a full-scale community-based exercise in one given year,
  • the facility is encouraged to choose in the following year a different hazard in their risk assessment to conduct an exercise to ensure variability in the training and testing program.
  • Clarification on the EP Exercise Exemption based on Actual Emergency -If an actual emergency event requires activation of the relevant emergency plan meets the full -scale exercise requirement, the clinic will be exempt from engaging in their next required community based full-scale or individual facility-based exercise.  Thus, since clinics required to conduct full-scale exercises only every other year, opposite of their exercises of choice, these facilities are exempt from their next required full-scale or individual facility-based exercise.
  • While not required to use volunteers as part of an EP plan to supplement or increase staffing during an emergency, the facility must have policies and procedures to address plans or emergency staffing needs.
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