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On August 15, the Centers for Medicare & Medicaid Services (CMS) released a Notice of Funding Opportunity (NOFO) for states participating in the Cell and Gene Therapy (CGT) Access Model. Under this model, CMS will negotiate outcomes-based agreements with gene therapy manufacturers to provide states additional Medicaid rebates if the CGTs do not perform as expected. The model will initially target sickle cell disease (SCD) given the high percentage of Americans living with SCD who are enrolled in Medicaid and the high cost of SCD therapies. CMS has noted that the model could be expanded to other categories of CGTs in future years, but has not promised to do so.
With this NOFO, states have the opportunity to apply for up to $9.55 million in Cooperative Agreement funding (for a total of $95.5 million available) to support their participation in the 11-year model. States may apply for implementation funding to support required and optional model activities and milestone funding if states successfully complete related research projects.
To be considered for funding, states must submit applications in response to the State Request for Applications and the NOFO by February 28, 2025. CMS expects to make awards by July 1, 2025. The model is set to begin on January 1, 2025, with rolling start dates for participating states through January 1, 2026.
For more information on how to subscribe and to activate a complimentary one week trial to Manatt on Health, please reach out to Barret Jefferds.