On September 11, 2023, the FDA approved and authorized updated COVID-19 vaccines from Pfizer and Moderna. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommended them for everyone from the ages of 6 months and older on September 12 and the CDC Director adopted this recommendation on the same day. This marks the first time that COVID-19 vaccines will be commercialized – that is, transitioned to the commercial market for their manufacturing, procurement and pricing.

Up until this point, the federal government had purchased all COVID-19 vaccines and provided them free of charge to anyone, regardless of insurance coverage or ability to pay. The commercial price being charged by Pfizer and Moderna is $115 to $128 per dose, respectively, about 3-4 times higher than the price paid for by the federal government. In addition to the cost of the vaccine, there may be a cost associated with administering the vaccine and/or the cost of a provider visit.

With commercialization, the way in which vaccines are paid for and whether they are covered by insurance will now be dictated by insurance market rules and regulations. Because of the Affordable Care Act and laws passed during the COVID-19 pandemic, COVID-19 vaccines will continue to be free of charge to virtually everyone with private and public insurance coverage, although uninsured adults will have no guarantee of free vaccines.

LEGAL BASIS

Private:

ACA: Requires private insurers to cover any ACIP recommended vaccine once the CDC Director adopts recommendation no later than one year later.

CARES Act: Expedited coverage requirement to 15 business days for COVID-19 vaccines

DOL FAQs: The 15-day requirement was already satisfied 15 days after first COVID-19 vaccine recommended in December 2020. As of January 5, 2021, any COVID-19 vaccine that is approved or authorized by the FDA must be covered immediately.

Medicaid:

ARPA: Requires no cost-sharing through September 2024

IRA: Requires Medicaid coverage of ACIP-recommended vaccines for adults with no cost sharing permanently.

Medicaid covers ACIP-recommended vaccines for children at no cost through the Vaccines for Children Program.

Medicare:

CARES Act: Requires no cost-sharing

Uninsured Adults:

There is no federal guarantee of free recommended vaccines for adults. Section 317 of the Public Health Services Act created a discretionary program that provides some limited support for recommended vaccines. The Biden administration has proposed creating a mandatory Vaccines for Adults Program, modeled on the Vaccines for Children Program

Uninsured Children:

Section 1928 of the Social Security Act created the VFC program. Vaccines are automatically included in program if recommended by ACIP and included on the CDC’s vaccine schedule. COVID-19 vaccines were added to the vaccine schedule on October 19, 2022.