December 14, 2020
In December of 2020, the Advisory Committee on Immunization Practices (ACIP), which is responsible for recommendations on U.S. adult and childhood immunizations, voted to approve the following recommendations regarding COVID-19 vaccine(s):
- The Pfizer-BioNTech COVID-19 vaccine is recommended for persons 16 years of age and older in the U.S. population under the Food and Drug Administration’s (FDA’s) Emergency Use Authorization (EUA).
- Amendment of the 2021 Adult and Child/Adolescent immunization schedules to include the COVID-19 vaccines within the scope of the EUA or Biologics License Application for the particular vaccine.
Under the CARES Act and implementing regulations, all group health plans—insured and self-insured—are required to cover ACIP-recommended vaccines with no cost-sharing (no copays, coinsurance, deductibles). Additional details on the Pfizer-BioNTech vaccine and evidence related to specific populations (age, pregnancy, etc.) are available in the ACIP meeting materials.
Effective Date
Employer-sponsored group health plans must cover the vaccine(s), without cost-sharing, within 15 business days after the vaccine is recommended by ACIP and the Centers for Disease Control and Prevention (CDC). Therefore, we recommend that group health plans be prepared to cover the Pfizer-BioNTech COVID-19 vaccine by January 1, 2021.
What's Next?
We expect that in the coming weeks and months, the FDA and ACIP will authorize and recommend additional COVID-19 vaccines that group health plans must then cover without cost-sharing. We also expect that other agencies will issue more specific guidance on COVID-19 vaccine coverage. We will keep our members updated on any new recommendations, guidance, and effective dates.
Resources
If you have questions, comments, or concerns about these or other regulatory and compliance issues, please contact us.
We provide this material for informational purposes only; it is not a substitute for legal advice.
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