Practical COVID-19 Vaccine Coverage in the Midst of Regulatory Confusion

Ongoing developments regarding COVID-19 vaccine coverage are causing employers who sponsor group health plans to grapple with shifting federal and state guidance, leaving many plan participants uncertain about their benefits for the upcoming flu season.

Federal Agency Recommendations and State Authority

The leading source of confusion is the involvement of multiple agencies. The Federal Drug Administration (“FDA”), which reviews the safety and efficacy of vaccines and how they are manufactured, released its COVID-19 vaccine approvals in August. However, it is the Centers for Disease Control and Prevention (“CDC”) and its Advisory Committee on Immunization Practices (“ACIP”) that issues public vaccine recommendations; typically after the FDA has issued its findings. Under the Affordable Care Act (“ACA”), most private group health plans must cover vaccines recommended by the CDC/ACIP without cost sharing when they are provided in-network. ACIP’s recommendations, originally due in June, were issued September 19th, but will not be final until they are adopted by the acting CDC Director. Ultimately, Department of Health and Human Services (“HHS”) Secretary Kennedy has the authority to accept, amend, or overrule the ACIP recommendation and the recommendations of CDC leadership.

While the Affordable Care Act requires private group health plans to cover CDC/ACIP recommended vaccines, the power to regulate vaccines is specifically reserved to the states under the Constitution as a public health activity (for example, vaccinations required to enroll in public school). States have typically tied their vaccine recommendations to the CDC/ACIP recommendations, but they are not required to.

FDA August 27th Vaccine Approvals

Per the FDA guidance the Pfizer, Moderna, and Novavax COVID-19 vaccines are approved for all adults aged 65 or older. They are recommended for individuals under the age of 65:

• Moderna (mSPIKEVAX): Six months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
• Pfizer (COMIRNATY): Five years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
• Novavax (NUVAXOVID): 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
• Moderna (mNEXSPIKE): 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

The FDA revoked all prior COVID-19 vaccine emergency use authorizations (“EUAs”) and noted that Moderna is now the only manufacturer with a licensed vaccine for children under the age of five.

The FDA guidance incorporates the list of “underlying health conditions” maintained by the CDC. These include chronic lung diseases, cancer, certain chronic kidney and liver diseases, diabetes, some disabilities, heart conditions, HIV, physical inactivity, primary immunodeficiencies, and specific mental health conditions.

CDC September 19th Recommendations

ACIP unanimously recommended that COVID-19 vaccinations for all individuals aged six months and older be determined individually through “Shared Clinical Decision-Making” (or, “SCDM”), which permits personalized vaccination decisions between patients and healthcare providers (including physicians, nurses, and pharmacists). Following a contentious vote, ACIP ultimately decided that the COVID-19 vaccine will not require a prescription.

Some uncertainty remains regarding coverage of pregnant women. In May, the CDC dropped its COVID-19 vaccine recommendation for pregnant women; however, pregnancy is still included on the CDC “underlying health condition” list. It was hoped that ACIP would provide additional guidance regarding the discrepancy, however, SCDM should allow pregnant women to receive the COVID-19 vaccine without cost-sharing if provided in-network; however, plan sponsors should discuss this with their group health plan network or insurer.

Regional Collaboration and State Recommendations

In response to the inconsistency on the federal level, states are engaging in regional collaboration and/or enacting their own vaccine legislation.

On September 3, 2025 California, Oregon, and Washington formed the “West Coast Health Alliance” (the “Alliance”), which was subsequently joined by Hawaii on September 4th. The Alliance will collaborate with health experts to develop unified immunization guidelines informed by national medical authorities and announced their first vaccine recommendations for COVID-19, flu, and RSV on September 17, 2025, which can be found here. The Alliance is also discussing data sharing and group purchasing.

In early in 2025, several northeastern states and New York City began collaborating on public health matters, and on September 18, 2025 they formally debuted as the Northeast Public Health Collaborative (the “Collaborative). As of September 23rd, members include Delaware, Connecticut, Maine, Maryland, Massachusetts, New Jersey, New York State, Pennsylvania, Rhode Island, Vermont, and New York City. Members will work together on vaccine recommendations and purchasing, and they will also cooperate on public health emergency preparedness and response, data collection and analysis, infectious disease, epidemiology and laboratory capacity and services.  The Collaborative issued their COVID-19 recommendations on September 15th, which can be found here.

States that are not part of the Alliance, Collaborative, or other regional group are also passing their vaccine legislation. For example, Colorado has recently mandated that preventive health recommendations from reputable medical bodies be covered by insurance, regardless of federal guidance. Independent health policy organization KFF provides a state vaccine policy tracker here.

Considerations for Employer Sponsored Group Health Plans

COVID-19 coverage options for sponsors of fully insured group health plans are limited by federal and state law, while sponsors of self-insured group health plans have more choice over how they will cover vaccines.

• Sponsors of fully insured plans should contact the insurer regarding how the COVID-19 vaccine will be covered, i.e., will the state(s) in which employees are offered coverage follow the CDC/ACIP recommendations, or does the state have its own standard for covering vaccines without cost-sharing? A plan sponsor in a state that follows the CDC/ACIP recommendations, but that wants to provide COVID-19 vaccines without cost-sharing more broadly, may be able to negotiate a side letter with the insurer (likely at an additional cost).
• Sponsors of self-insured plans are only required to provide CDC/ACIP recommended vaccines without cost-sharing in network but can choose to provide more coverage than required.  If a plan sponsor decides to provide more coverage of COVID-19 vaccines (and other vaccines) than recommended by the CDC/ACIP, coverage based on an objective standard from a national medical authority is recommended.
• Sponsors with both fully and self-insured plans should determine whether coverage of COVID-19 vaccines is different between the plans, and work with legal counsel to determine if and how to make vaccine benefits consistent for plan participants.
• Plan sponsors that use pharmacy benefit managers (“PBMs”) to administer their prescription benefits should contact their PBM regarding COVID-19 vaccine coverage at pharmacies.

Last (but not least!) make sure that information about plan coverage of COVID-19 vaccines is clearly communicated to plan participants. Plans have already reported receiving questions from participants who were denied or charged for a COVID-19 shot.

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Please contact legal counsel for further advice and help navigating COVID-19, and other vaccine, compliance.