On April 25, HHS Secretary Robert F. Kennedy Jr. said that 35 states have agreed to participate in the Center for Medicare & Medicaid Services (CMS) Innovation Center's Cell and Gene Therapy (CGT) Access Model. One of these states, California, announced on April 14 that CMS approved its application to participate—marking the first public announcement of a state being selected to join the model.
Under the 11-year model, CMS has negotiated and will administer value-based contracts with bluebird bio and Vertex Pharmaceuticals—manufacturers of the only two sickle cell disease (SCD) gene therapies approved by the Food and Drug Administration—to provide states additional Medicaid rebates if the therapies do not perform as expected. The model is initially targeting gene therapies for SCD because of the high cost of these therapies and the large number of Medicaid enrollees with SCD. According to Secretary Kennedy, the 35 states selected represent about 84 percent of Medicaid enrollees with the disease. Appearing alongside Secretary Kennedy, the Innovation Center's Director, Abe Sutton, said they are seeking input from states on expanding the model to include additional categories of CGTs.
States had until March 14 to respond to the request for applications and Notice of Funding Opportunity. CMS is working with states to execute State Agreements on a rolling basis by June 1 and will announce funding awardees by July 1. States will have rolling start dates through January 2026.
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