CMS Announcement on the Cell and Gene Therapy Access Model

On Dec. 4, 2024, the Centers for Medicare and Medicaid Services (CMS) announced that two drug manufacturers of gene therapies for sickle cell disease have entered into agreements to participate in the Cell and Gene Therapy Access Model (CGT Access Model). 

• The CGT Access Model is a model from the Center for Medicare and Medicaid Innovation (CMMI). It is voluntary for both states and manufacturers. 
  • Cell and gene therapies have great potential but high cost.
  • Under the CGT Access Model, CMS would administer multi-state, outcomes-based agreements with manufacturers on behalf of state Medicaid agencies. These agreements tie payments to whether the therapy improves outcomes for those receiving the treatments. 
  • The CGT Access Model will allow Medicaid beneficiaries access to potentially life-changing, high-cost specialty drugs. 
• Sickle cell disease disproportionately impacts Black and Hispanic Americans and has historically had limited treatment options. 
• The CGT Access Model launches in January 2025. State may apply to participate via the application portal from Dec. 4, 2024 through Feb. 28, 2025. In addition, states may apply for optional model funding, also with a deadline of Feb. 28, 2025. 

More on This Topic: 

• Press Release
• Fact Sheet
• Cell and Gene Therapy Access Model Webpage
• State Application Portal 
• Notice of funding opportunity 

For questions, please reach out to Vicky Jucelin.