Last week, CMS’ Center for Medicare and Medicaid Innovation (CMMI) announced that sickle cell treatment will be the first focus of its Cell and Gene Therapy (CGT) Model. The voluntary model tests whether Medicaid patients are benefitted from the agency’s negotiating and administering outcomes-based arrangements. Sickle Cell Disease is an under-researched, painful genetic disease with serious health equity implications; African-American and Black communities have the highest incidence in the nation. While CMS is starting with Sickle Cell Disease under the CGT Model, the Agency is considering additional diseases to include in the model in the future.

The model works by placing CMS as negotiator between cell and gene therapy manufacturers and state Medicaid programs. The outcomes-based arrangements they agree upon will tie pricing for sickle cell disease treatments to whether those therapies actually improve health outcomes for enrollees.

States who participate will be required to update their reimbursement structures to reimburse for gene therapy. This might involve aligning coverage policies with Medicaid managed care organizations, contracting with out-of-state providers, or implementing new data collection practices. To help, CMS will provide funding to states through a cooperative agreement. States who choose to participate will be able to select between two start dates: January 2025 or January 2026.

Manufacturers will also have to opt-in to the model. To qualify, manufacturers’ therapies must be approved by the Food and Drug Administration by no later than May 2024. CMS will negotiate outcomes-based arrangements with manufacturers selected to participate.