CMS Cell and Gene Therapy (CGT) Access Model for Casgevy™ (exagamglogene autotemcel) and Lyfgenia® (lovotibeglogene)

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).

Important Reminders

Coverage Guidelines

With CMS approval to participate in the CGT Access Model, and an anticipated effective date of January 1, 2026, NYS Medicaid providers should be aware of the following the coverage guidelines:

• Casgevy™ and Lyfgenia® will be reimbursed by the NYS Medicaid fee-for-service (FFS) program for Medicaid Managed Care (MMC) enrollees and FFS members.

• For MMC enrollees, consideration of approval for treatment-related medical care will be determined by the individual managed care plan.
• The model also includes a fertility preservation provision provided by the manufacturers of Casgevy™ and Lyfgenia®.

Billing Guidelines

Providers may not use 340B inventory for the CGT Access Model drugs.

Drug Administration Claim Submission

For Medicaid members enrolled in Healthfirst, payment for drug administration will be made through the Plan. Providers should check with Healthfirst regarding specific medical coverage criteria, and reimbursement.

Additional Resources

• CGT Access Model Frequently Asked Questions | CMS
• New York State Medicaid General Billing Guidelines | eMedNY
• Medicaid Practitioner Administered Drugs Update: CMS Cell and Gene Therapy (CGT) Access Model for Casgevy™ (exagamglogene autotemcel) and Lyfgenia® (lovotibeglogene autotemcel) | eMedNY

Questions?

If you have questions, please contact your network account manager, or Healthfirst Provider Services at 1-888-801-1660, Monday to Friday, 8:30am–5:30pm.