Cell and Gene Therapy (CGT) Access Model

Objective

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.

Who Can Apply

• State
• U.S. Territory (or Possession) Government (including freely-associated states)
• U.S. State Government (including the District of Columbia)

Eligible applicants are States, the District of Columbia, and any U.S. Territory participating in the Medicaid Drug Rebate Program (MDRP). Eligible applicants must: • Apply to the State Request for Applications (RFA) by no later than March 14, 2025 • Apply to the Notice of Funding Opportunity (NOFO) by no later than March 14, 2025 • Sign a State Agreement with CMS by no later than June 1, 2025

Who Benefits

• State
• U.S. Territories

To be eligible for gene therapy to treat sickle cell disease as part of this model, a person must: • Have a documented medical diagnosis for sickle cell disease. • Be enrolled in Medicaid or CHIP (if applicable) in a state participating in the model at time of therapy. • Have Medicaid as their primary payer. • Receive a gene therapy from a participating manufacturer. • Meet standardized prior authorization criteria established through the OBAs.

Assistance Types

• Cooperative Agreement

Program Contact

melissa.majerol@cms.hhs.gov
410-786-6593