Cell and Gene Therapy Access Model — Casgevy and Lyfgenia coverage for eligible Medicaid enrollees with sickle cell disease
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Defines the new benefit and access model for FDA-approved cell and gene therapies (Casgevy and Lyfgenia) for Medicaid enrollees with sickle cell disease in the District of Columbia, and describes authorization, coverage responsibilities, and clinical eligibility highlights for providers.
MedStar Family Choice DC will cover CMS-authorized cell and gene therapies (Casgevy and Lyfgenia) for qualifying Medicaid enrollees with sickle cell disease effective January 1, 2026.
Prior authorization for CGT medications must be obtained from DHCF's vendor, Comagine Health, before administering inpatient CGT services.
Coverage is limited to Medicaid participants aged 12 and older with genetically confirmed sickle cell disease who meet CMS clinical criteria.
Medicaid Managed Care Plans are responsible for all healthcare costs associated with CGTs except the medication reimbursement which is DHCF responsibility.
Coverage Criteria for Cell and Gene Therapies
Initial therapy eligibility
Covered when ALL of the following are met
From DHCF participation in CGT Access Model; genetic confirmation required
Casgevy-specific clinical criteria per DHCF alert
Lyfgenia-specific clinical criteria per DHCF alert
Coverage of cell and gene therapies under this policy is limited to Medicaid participants enrolled in the District of Columbia. Coverage applies only to eligible Medicaid enrollees aged 12 years and older with a confirmed diagnosis of sickle cell disease via genetic testing. Non‑Medicaid members are excluded from this benefit. Medicaid Managed Care Plans remain responsible for all routine healthcare costs associated with care and administration of CGTs (for example, diagnostics, facility costs, provider fees, monitoring, adverse event management, supportive care, behavioral health, care coordination, and transportation), while DHCF is responsible for reimbursement of the approved CGT medications (Casgevy and Lyfgenia).
Lyfgenia is not eligible for enrollees who have previously received a hematopoietic stem cell transplantation. One of the stated Lyfgenia clinical criteria is that the enrollee has not received prior transplantation, and documentation confirming absence of prior hematopoietic stem cell transplant is required for Lyfgenia authorization.
Provider Requirements and Prior Authorization
DHCF prior authorization required
Providers must obtain prior authorization from DHCF's vendor, Comagine Health, for Casgevy and Lyfgenia before administering inpatient cell and gene therapy services; DHCF-specific prior authorization forms for Casgevy and Lyfgenia are provided and must be used.
- DHCF Casegevy PA Form and DHCF Lyfgenia PA Form links are provided in the alert.
Hydroxyurea failure or intolerance must be documented
Documented failure or intolerance of hydroxyurea is required before a patient is considered eligible for either Casgevy or Lyfgenia.
- Casgevy criteria list “Failure or intolerance of Hydroxyurea.”
- Lyfgenia criteria list “Failure or intolerance of Hydroxyurea.”
Required documentation to include with PA request
When requesting prior authorization for Casgevy or Lyfgenia, providers must submit the DHCF prior authorization form plus diagnosis confirmation, patient history of prior treatment failures, justification for the therapy, and other relevant clinical documentation.
- Diagnosis confirmation
- Patient history of prior treatment failures
- Justification for the therapy
- Other relevant and necessary clinical documentation
- DHCF prior authorization form for the specific therapy
Obtain PA before inpatient administration to avoid denial
Failure to obtain prior authorization from DHCF's vendor, Comagine Health, prior to administering inpatient CGT medications may result in denial of medication reimbursement and potential financial responsibility for the provider or enrollee.
- DHCF is responsible for reimbursement of approved CGT medications only when prior authorization is obtained from Comagine Health.
- Medicaid Managed Care Plans retain responsibility for other associated healthcare costs, but medication reimbursement denial may occur without PA.
Background and Clinical Context
Sickle cell disease is a hereditary hemoglobinopathy that causes recurrent vaso‑occlusive events and other serious complications; disease‑modifying therapy such as hydroxyurea has been the standard of care for many patients. Recently, the FDA approved two cell and gene therapies, Casgevy and Lyfgenia, for selected patients with sickle cell disease who meet CMS clinical criteria. Because the District of Columbia has a higher prevalence of sickle cell disease than the national Medicaid population and MedStar Family Choice DC participates in the federal CGT Access Model, DHCF is expanding access to these therapies for qualifying Medicaid enrollees effective January 1, 2026.
Definitions and Model Description
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