Cell and Gene Therapy (CGT) Access Model

The Centers for Medicare & Medicaid Services (CMS), under the U.S. Department of Health and Human Services, has announced a Notice of Funding Opportunity (NOFO) for the Cell and Gene Therapy (CGT) Access Model. This funding opportunity supports states, the District of Columbia, and U.S. territories participating in the Medicaid Drug Rebate Program (MDRP) in implementing the CGT Access Model. The model is designed to enhance access to innovative cell and gene therapies, specifically targeting sickle cell disease (SCD). The total funding available for this initiative is $95.5 million, with individual awards of up to $9.55 million per recipient. The CGT Access Model is a voluntary initiative that tests whether a CMS-led approach to outcomes-based agreements (OBAs) can improve access to cell and gene therapies for Medicaid beneficiaries. CMS will negotiate standardized OBA key terms with gene therapy manufacturers, ensuring predictable pricing models and rebate structures to reduce Medicaid healthcare expenditures while improving patient health outcomes. The model focuses exclusively on gene therapies for sickle cell disease approved or licensed by the U.S. Food & Drug Administration (FDA). States opting to participate in the model will be required to adopt these OBAs, ensuring uniformity and efficiency in Medicaid reimbursement processes. Funding under this NOFO is categorized into Implementation Funding and Milestone Funding. Implementation Funding supports states in launching the model, including activities such as provider education, improving access to hematologists and transplant specialists, and streamlining Medicaid policies. Milestone Funding is awarded for research initiatives aimed at improving access to gene therapy and enhancing multidisciplinary care for SCD patients. The cooperative agreements span a performance period of up to 10.5 years, with the model set to conclude on December 31, 2035. Eligible applicants must be U.S. states, the District of Columbia, or U.S. territories that participate in the MDRP. A state must apply to both the State RFA and this NOFO, as well as sign a State Agreement with CMS by June 1, 2025. Applications must be submitted electronically through Grants.gov by March 14, 2025, at 11:59 PM EST. CMS anticipates issuing awards by July 1, 2025. The model does not require cost-sharing or matching funds, making it accessible for states seeking financial support in implementing these healthcare reforms. The application process includes detailed submission requirements, including a Project Narrative, Budget Narrative, and compliance with federal financial reporting systems such as System for Award Management (SAM.gov). Applications will be reviewed based on programmatic approach, organizational capacity, budget feasibility, and compliance with Medicaid and CHIP policies. CMS will host informational webinars before the submission deadline to assist applicants with the process. For further inquiries, CMS provides direct contact points for programmatic and budget-related questions, ensuring clarity for prospective applicants. Interested states must carefully review the NOFO guidelines and ensure compliance with all federal requirements before submission.