Understanding Coverage Considerations for COVID-19 Vaccines and Treatments (Updated May 2023)
This report was initially released in August 2022 and subsequently updated in May 2023 to reflect recent legislative changes to Medicare Part D, the planned expiration of the COVID-19 Public Health Emergency Declaration on May 11, 2023, and the announcement that the monoclonal antibody Evusheld is no longer authorized for emergency use by the FDA as of January 23, 2023.
COVID-19 vaccines and treatments have been an important tool in the prevention of COVID-19, including preventing hospitalizations and deaths. After the public health emergency (PHE) for COVID-19 ends, COVID-19 vaccines and treatments will need to transition from direct government purchase under Emergency Use Authorizations (EUAs) to established regulatory pathways for FDA coverage and payment by public and private payers. In preparation for this process, which we refer to as "commercialization", this report: 1) provides an overview of the current coverage and payment of COVID-19 vaccines and treatments across payers; 2) identifies expected gaps in coverage after the end of U.S. Government-provided supply and key considerations for coverage determinations post-PHE; and 3) presents estimates on expected savings and spending offsets for a select set of COVID-19 products that have been demonstrated to reduce COVID-19-related hospitalizations. The report concludes with potential next steps for payers as they navigate the coverage and payment process to prevent gaps in availability of lifesaving COVID-19 vaccines and treatments.
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