Recently, the U.S. Food and Drug Administration (FDA) authorized a second booster dose for both the Pfizer-BioNTech and the Moderna COVID-19 vaccines for people meeting an age requirement and certain immunocompromised individuals who are higher risk. This new approval could have group health plan implications, explained further below.
Group health plans covered by the Affordable Care Act (ACA) are generally required to provide coverage for FDA-approved vaccinations when recommended by the Advisory Committee on Immunization Practices (ACIP). Further, the Families First Coronavirus Response Act (FFCRA) requires group health plans (including fully insured, self-insured, and level funded plans) and health insurance issuers to provide benefits for items and services related to the testing and diagnosis of COVID-19 as of March 18, 2020, and through the applicable emergency period (which has not yet expired). This coverage must be provided without cost-sharing requirements (including deductibles, copayments, and coinsurance), prior authorization, or other medical management techniques. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) amended the FFCRA to include a broader range of items and services that must be covered, including coverage for approved COVID-19 vaccines when recommended by the ACIP.
New FDA Approval
On March 29, 2022, the FDA amended its emergency use authorization (EAU) and now approves the following at least 4 months after receiving the first booster dose of any approved COVID-19 vaccine:
- Pfizer-BioNTech booster to individuals aged 50+ and individuals aged 12+ with certain kinds of immunocompromise; and
- Moderna COVID-19 booster to individuals aged 50+ and individuals aged 18+ with certain kinds of immunocompromise.
Impact to Group Health Plans
While the FDA has expanded its EAU, the ACIP has not currently amended its COVID-19 recommendations to include the FDA approved second booster as described above. Since coverage for FDA approved COVID-19 vaccines is required when recommended by the ACIP, it appears that group health plans (including fully insured, self-insured, and level funded plans) are not required to provide coverage without cost sharing for the second FDA-approved booster. However, should the ACIP update its recommendation to include the second booster, group health plans will likely be required to provide coverage for the second FDA-approved booster (as described above), and provide such coverage without cost sharing.
Employers may want to review plan terms and discuss with carriers (as applicable) to determine if their group health plan will provide coverage for the second COVID-19 booster based on the above information. We will continue to monitor and communicate updates, particularly if the ACIP amends its COVID-19 recommendations to include the second booster. Without further guidance, employers should consult counsel on this matter should further questions arise.
- FDA Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dost of Two COVID-19 Vaccines for Older and Immunocompromised Individuals
- FAQs about FFCRA and CARES Implementation Part 44 (February 26, 2021)
- FAQs about FFCRA and CARES Implementation Part 50 (October 4, 2021)
- Sequoia Foreword: FAQs Released on Coverage for COVID-19 Testing and Vaccinations