CMS Highlights the COVID-19 Vaccines That Must Be Covered


CMS has provided a chronological listing of FDA approvals and authorizations for COVID-19 vaccines in the United States.


The Centers for Medicare & Medicaid Services (CMS) recently updated its COVID-19 vaccine toolkit to include a list of COVID-19 vaccines and boosters that must be covered without cost sharing. The updated toolkit now includes a chronological list of the Food and Drug Administration’s (FDA) approvals and authorizations for COVID-19 vaccines and boosters in the United States.



Non-grandfathered group health plans are required to cover any vaccine authorized by the FDA under an Emergency Use Authorization (EUA) or approved under a Biologics License Application (BLA) without cost sharing immediately upon authorization or approval. Coverage must be consistent with the scope of the EUA or BLA for the particular vaccine, including amendments allowing for the administration of an additional dose or booster doses, or the expansion of the age demographic for whom the vaccine is authorized or approved.

Grandfathered plans may choose to cover the vaccine and could be required to do so under state law or applicable insurance policies.


CMS COVID-19 Vaccine Toolkit

CMS issued the COVID-19 vaccine toolkit to help health insurance issuers identify the issues that must be considered to provide coverage and reimbursement for COVID-19 vaccine administration. The toolkit:

  • Provides a list of operational considerations and information on how issuers can communicate with providers and enrollees on vaccines and coverage;
  • Outlines recent legislative and regulatory provisions related to COVID-19 vaccine coverage and administration; and
  • Encourages issuers to implement streamlined processes to quickly administer COVID-19 vaccine coverage.



  • Non-grandfathered group health plans and insurance issuers must cover COVID-19 preventive services without cost sharing.
  • Preventive care services include recommended immunizations.
  • This coverage must be provided for both in-network and out-of-network providers during the COVID-19 public health emergency.


This Legal Update is not intended to be exhaustive nor should any discussion or opinions be construed as legal advice.