93.885: Cell and Gene Therapy (CGT) Access Model

93.885

Active

Centers for Medicare and Medicaid Services (CMS) [HHS]

Feb. 15, 2024

Feb. 15, 2024

The Cell & Gene Therapy Access Model is a voluntary model intended to improve the lives of Medicaid beneficiaries living with rare and severe diseases by increasing access to cell and gene therapies, which are 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. Under the Model, the Center for Medicare and Medicaid Services (CMS) will form a partnership between CMS, pharmaceutical manufacturers (hereinafter, “Manufacturers”) of CGTs, and States, wherein they agree upon an outcomes-based agreement (OBA) that will include discounted prices for the therapies, a uniform access policy for all eligible beneficiaries in participating States, and rebates to States if the therapies do not perform as expected in the Model population. The Model seeks to test whether a CMS-led approach to negotiating and administering outcomes-based agreements (OBAs) for CGTs, while addressing a broad range of access barriers will improve beneficiary access and health outcomes, and reduce health care costs. Assistance Listing goals: • Provide States with funding to support Model implementation and optional partnerships with community-based organizations. • Provide States with funding if they achieve milestones associated with improving equitable access to gene therapy for SCD and promoting multi-disciplinary, comprehensive care that address access barriers.

The Centers for Medicare & Medicaid Services (CMS) is seeking applications from State Medicaid Agencies from any state, the District of Columbia, and any U.S. territory that participates in the Medicaid Drug Rebate Program (MDRP) (hereinafter, “States”) for optional funding under the Cell & Gene Therapy Access Model (the CGT Model or “the Model”). To be considered for funding under this NOFO, the State must: • Submit the State RFA application at the same time as, or before, submitting a NOFO application • Participate in the Model by applying to the Cell and Gene Therapy Model State Request for Application (RFA) by no later than February 28, 2025 and signing a State Agreement with CMS • Apply to this NOFO by no later than February 28, 2025

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. • Beneficiaries for whom Medicaid is the primary payer. • Receive a gene therapy from a participating manufacturer. • Meet standardized prior authorization criteria established through the OBAs.

https://sam.gov/fal/f8f87411724c4d2294532bb069e162e3/view