CMS Cell and Gene Therapy (CGT) Access Model

  • Letter is also available in Portable Document Format (PDF)

January 12, 2026

Dear Medicaid Managed Care Plan Representative,

The New York State (NYS) Department of Health has applied to participate in the federal Centers for Medicare and Medicaid Services (CMS) Cell and Gene Therapy (CGT) Access model. The model is voluntary for State Medicaid programs and manufacturers and will test whether a CMS-led approach to developing outcomes-based agreements (OBAs) for cell and gene therapies increases Medicaid beneficiaries’ access to innovative treatment, improve health outcomes, and reduces health care costs to State Medicaid programs. The initial focus of the model is on gene therapies for people living with sickle cell disease, inclusive of Casgevy™ (exagamglogene autotemcel) and Lyfgenia® (lovotibeglogene autotemcel).

With CMS approval to participate in the CGT Access Model, and an anticipated effective date of January 1, 2026, NYS Managed Care Plan’s should ensure:

  • The gene therapy is administered at an in-network qualified treatment center or have a single case agreement.
  • Providers who submit a claim must be a member of the CMS-designated patient registry (i.e., the Center for International Blood & Marrow Transplant Research - CIBMTR) and participate in a CMS-specified study. A list of participating centers is available on the CIBMTR website.
  • Continuity of care for beneficiaries that may transition between fee-for-service and managed care, or among Managed Care Plans.
  • Beneficiaries continue to have access to their Sickle Cell Disease gene therapy providers for at least one year after receiving gene therapy.
  • Providers have access to a primary and secondary Managed Care Plan representative.
  • A Managed Care Plan representative is aware of the coverage policy guidance in the October 2025 Medicaid Update.

If you have any questions, please reach out to NYRx@health.ny.gov.

Sincerely,

Division of Program Development & Management
Office of Health Insurance Programs