CMS Cell and Gene Therapy (CGT) Access Model
- FAQs is also available in Portable Document Format (PDF)
Frequently Asked Questions (FAQs)
Published: 1/12/2026
FAQ 001
Question: For Casgevy when utilized for the diagnosis of beta thalassemia, can Casgevy claims be billed to the NYS Medicaid fee-for-service (FFS) program in the same manner for the diagnosis of sickle cell disease?
Answer: Yes. Casgevy will be “carved-out” of MC for both indications (beta thalassemia and sickle cell disease) and reimbursed by the NYS Medicaid FFS program for Medicaid Managed Care enrollees as well as FFS members.
FAQ 002
Question: If a provider is not listed in the CMS-designated registry, how should MCOs proceed?
Answer: For clarification, “provider” is the participating center (i.e., qualified treatment center). The gene therapy (i.e., Casgevy and Lyfgenia) must be administered by a provider at a participating center. The list of participating centers can be found here.
FAQ 003
Question: If the MCO approved Casgevy or Lyfgenia therapy prior to 1/1/2026 but administration of the gene therapy is scheduled to take place on or after 1/1/2026, can the Casgevy or Lyfgenia claim be billed to the NYS Medicaid FFS program?
Answer: Yes. The MCO should ensure the following form is submitted to NYS DOH (NYRx@health.ny.gov). The Cell and Gene Therapy Form must be submitted in a secure manner (e.g., encrypted).
