Cell and Gene Therapy (CGT) Access Model

The Cell and Gene Therapy (CGT) Access Model aims to improve the lives of people with Medicaid living with rare and severe diseases by increasing access to potentially transformative treatments. It is a multi-year, voluntary model for states and manufacturers to test whether a CMS-led approach to developing and administering outcomes-based agreements (OBAs) for cell and gene therapies increases Medicaid beneficiaries’ access to innovative treatment, improves their health outcomes, and reduces health care costs and burden to state Medicaid programs. The initial focus of the model is on access to gene therapy treatments for people living with sickle cell disease, a genetic blood disorder. Manufacturers and state participants joined the model through a Request for Application (RFA) process. States begin participation between January 2025 and January 2026. The Notice of Funding Opportunity (NOFO) announced the opportunity to apply for Cooperative Agreement funding to support states’ participation in the CGT Access Model. Cooperative Agreement funding is intended to support state model implementation activities and to support states that take steps to improve equitable access to gene therapy and multi-disciplinary, comprehensive care in conjunction with the model test.