CMS Opens Request for Application for CGT Access Model

The Centers for Medicare and Medicaid Services (CMS) opened the request for application (RFA) process for the agency’s Cell and Gene Therapy (CGT) Access Model, which aims to improve health outcomes and increase access to cell and gene therapies for some of the nation’s most vulnerable populations.

Under the CGT Access Model, CMS will negotiate outcomes-based agreements between states and pharmaceutical manufacturers, which will tie pricing for cell and gene therapies for individuals with rare and severe diseases to tangible improvements in health outcomes. The model’s first focus will be on therapies for sickle cell disease (SCD).

The RFA is open to pharmaceutical manufacturers participating in the Medicaid Drug Rebate Program (MDRP) and marketing FDA-approved gene therapies for SCD. The RFA describes the model's design elements, eligibility criteria, negotiation process, participation requirements, data collection, financial considerations, model timeline and legal and regulatory compliance. The agency anticipates releasing an RFA for interested states this summer.

The CGT Access Model will begin in January 2025. Additional information is available online.