Assistance program
Cell and Gene Therapy (CGT) Access Model
$9.3 Million committed in FY2025–FY2026
- Agency
- Centers for Medicare and Medicaid Services, Health and Human Services, Department of
- Assistance
- Not Applicable
- CFDA number
- 93.885
- What it does
- 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. Cell and gene therapies have high upfront costs but have the potential to reduce health care spending over time by addressing the underlying causes of disease, reducing the severity of illness, and reducing health care utilization. Initially, the model will focus on access to gene therapy treatments for people living with sickle cell disease, a genetic blood disorder that disproportionately affects Black Americans. The Notice of Funding Opportunity (NOFO) announces the opportunity to apply for Cooperative Agreement funding to support states’ participation in the CGT Access Model. The CGT Access Model is a voluntary model for states and manufacturers that tests whether a CMS-led approach to developing and administering outcomes-based agreements (OBAs) for cell and gene therapies improves Medicaid beneficiaries’ access to innovative treatment, improves their health outcomes, and reduces health care costs and burdens to state Medicaid programs. Within this model, CMS will negotiate standard key terms of an OBA directly with manufacturers of gene therapies approved or licensed by the U.S. Food & Drug Administration (FDA) for the treatment of sickle cell disease. After the key terms have been disclosed, states: (1) may apply to participate in the model in response to the State Request for Applications (RFA); and (2) may apply for Cooperative Agreement funding in response to the NOFO. • 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 benefits
- 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.
Committed by fiscal year
* FY2026 is year-to-date — the fiscal year is still in progress, so its total is still filling in. The striped band and dashed line mark that provisional stretch.
Top recipients
By dollars committed.
How to read these numbers
- Committed through this program
Money committed under this assistance listing (its CFDA program), counted in the year each action happened.
- How it's paid
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- Some recipients aren't itemized
For entitlement programs like Social Security and Medicare, the government reports one aggregate instead of naming tens of millions of people, so the recipient roster isn't part of the public record.
- Awards, counted once
An award count is the number of distinct awards with at least one action that year — each counted once, however many times it was amended.
- The colored bars
Every bar on this page splits by how the money moves:
Direct payments