33 states to participate in CMS ‘CGT Access Model’

The Centers for Medicare & Medicaid Services (CMS) announced that 33 states, plus the District of Columbia and Puerto Rico, will participate in the Cell and Gene Therapy Access Model, an outcomes-based payments program that aims to deliver CGT treatments for people on Medicaid living with sickle cell disease.

Participating states represent approximately 84% of Medicaid beneficiaries with sickle cell disease.

Led by the CMS Innovation Center, the model enables the federal government to negotiate outcomes-based agreements with CGT manufacturers on behalf of state Medicaid agencies. Under the model, participating states receive guaranteed discounts and rebates from participating CGT manufacturers if the therapies fail to deliver their promised therapeutic benefits. 

The model is voluntary for states and manufacturers; participation is open to manufacturers that responded to CMS’ request for applications and agreed to negotiate terms based on clinical outcomes. The following states and territories are participating: Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Illinois, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, and Wisconsin, as well as the District of Columbia and Puerto Rico.

The CGT Access Model which was initially announced by the Biden Administration in February 2023 and set to launch in 2025. In January 2024, the administration designated sickle cell disease as the initial focus of the model.