The CMS Vaccine Mandate: Are Boosters Required?

Our previous blog post provided an overview of the Centers for Medicare and Medicaid Services’ (“CMS”) Vaccine Mandate and addressed two basic questions of the mandate: What providers are covered and what’s the timeline to comply? Many of our healthcare and business law firm’s clients have additional questions about the requirement of CMS’ vaccine mandate (a.k.a. the “federal healthcare worker vaccine mandate”). One such question is: Does the mandate require individuals to receive a booster shot to comply with the mandate? This blog post outlines CMS’s current stance on the booster requirement. As always, the analysis herein is current as of the date this blog is posted and subject to change as agencies and courts release new decisions.

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SHORT ANSWER: The CMS Vaccine Mandate does not require individuals to receive booster shots or additional doses in addition to the primary vaccination series, but that may change.

Digging in further, CMS’s Interim Final Rule setting forth the mandate provided:

Consistent with CDC guidance, we consider staff fully vaccinated if it has been 2 or more weeks since they completed a primary vaccination series for COVID-19. We define completion of a primary vaccination series as having received a single-dose vaccine or all doses of a multi-dose vaccine. Currently, CDC guidance does not include either the additional (third) dose of an mRNA COVID-19 vaccine for individuals with moderately or severely immunosuppression or the booster dose for certain individuals who received the Pfizer-BioNTech Vaccine in their definition of fully vaccinated. Therefore, for purposes of this IFR, neither additional (third) dose nor booster doses are required.

As such, it appears CMS looks to the CDC to determine what is meant by “fully vaccinated.” The CDC has a webpage devoted to explaining what it means to be “up to date” and “fully vaccinated,” which do not mean the same thing. As of the date of this blog post, “up to date means a person has received all recommended COVID-19 vaccines, including any booster dose(s) when eligible,” and “fully vaccinated means a person has received their primary series of COVID-19 vaccines.”

On January 20, 2022, CMS released updated guidance through its evolving “External FAQ: CMS Omnibus COVID-19 Health Care Staff Vaccination Final Rule.” Therein, CMS shows it continues to treat boosters the same as when it drafted the IFC, in that the FAQ provides the following: “For purposes of this regulation, CMS currently considers staff fully vaccinated if it has been two weeks or more since they completed a primary vaccination series for COVID-19.” “Additionally, and for the purposes of this rule, documented receipt of additional or booster doses is not currently needed for staff who have completed a COVID-19 primary vaccination series.” Note, staff satisfies the requirements if the individual received the second shot by the Phase 2 implementation date “even if they have not yet completed the 14-day waiting period required for full vaccination.”

*Disclaimer: Thoughts shared here do not constitute legal advice.