CMS Releases Updated Guidance to Interim Vaccination Rule

CMS has released revised interpretive guidance for the COVID-19 vaccine mandate interim final rule (IFR). Three memoranda have been updated, including QSO-22-07-ALL-Revised, QSO-22-09-ALL-Revised, and QSO-22-11-ALL-Revised.
The revisions were made to clarify the expectations for assessing compliance with the requirement to ensure all staff are vaccinated. Below we have highlighted key revisions, but providers are encouraged to review the Long-Term Care and Skilled Nursing Facility Attachment A-Revised, as well as the applicable memo listed above, for detailed changes. 
  • Updated definition of “temporarily delayed vaccination” to include (deferred) and known COVID-19 infection until recovery from the acute illness (if symptoms were present) and criteria to discontinue isolation have been met.
  • Clarified that facility staff who have been suspended or are on extended leave (e.g., FMLA, workers comp) would not count as unvaccinated staff for determining compliance. 
  • Clarified that the list of “additional precautions” is not an all-inclusive list required to be followed.
    • Specifically, CMS states: “This requirement is not explicit and does not specify which actions must be taken. The examples are not all inclusive and represent actions that can be implemented. However, facilities can choose other precautions that align with the intent of the regulation which is intended to ‘mitigate the transmission and spread of COVID-19 for all staff who are not fully vaccinated.'”
  • Survey Process Updates for tag F888:
    • Surveyors will use the facility staff vaccination list or the Staff Vaccine Matrix to get a sampling of staff which will include contracted staff. Surveyors may modify the staff vaccination compliance review if the facility was determined to be in substantial compliance with this requirement within the previous six weeks. For Life Safety Code (LSC)-only complaint or LSC-only follow-up surveys, staff vaccination requirements are not required to be investigated.
  • Added a note clarifying that failure of contract staff to provide evidence of vaccination status reflects noncompliance and should be cited at F88. 
  • Expanded upon options for surveys to lower scope and severity to recognize good-faith efforts, specifically:
  • Surveyors and CMS may lower the scope and severity of a citation and/or enforcement action if they identify that any of the following have occurred prior to the survey (note: noncompliance is still cited, only the scope, severity, and/or enforcement is adjusted):
  • If the facility has no or limited access to the vaccine, and the facility has documented attempts to obtain vaccine access (e.g., contact with health department and pharmacies).
  • If the facility provides evidence that they have taken aggressive steps to have all staff vaccinated, such as advertising for new staff, hosting vaccine clinics, etc.
    • For example, if the facility staff vaccination rate is 90 percent or more, there is no resident outbreak in the previous 4 weeks, and all policies and procedures were developed and implemented, per Table 1 this would be cited “D.” However, if the facility provides evidence that it has made a good faith effort by taking aggressive steps to get all staff vaccinated, surveyors may lower the citation to “A.”
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