Cell and Gene Therapy (CGT) Access Model
General Frequently Asked Questions (FAQs)
Updated June 27, 2025
The following FAQs provide general guidance and clarification regarding the CGT Access Model. As the Department of Health Care Services (DHCS) receives additional questions, this FAQ will be updated.
General
What are CGTs?
CGTs are a class of one-time treatments, many of which are developed to treat rare and severe diseases, such as sickle cell disease (SCD). CGTs can correct underlying causes of a disease, address symptoms, and slow or stop disease progression.
What is the CGT Access Model?
This model aims to improve and streamline access to life-changing CGT medications for Medi-Cal members in both the fee-for-service (FFS) and managed care delivery systems with rare and severe diseases. The initial focus of Medi-Cal’s CGT Access Model, in alignment with Centers for Medicaid and Medicare Services (CMS) requirements, will be for CGT medications for Medi-Cal members with SCD. For more information on CMS’ CGT Access Model, you can visit this website: https://www.cms.gov/priorities/innovation/innovation-models/cgt.
When does Medi-Cal’s CGT Access Model start?
Eligible Medi-Cal members may begin accessing CGT treatments no sooner than July 1, 2025. Medi-Cal members should speak to their treating health care providers to determine if they may be eligible for CGT medications and whether they may be right to address their health care needs, as described in more detail in question #9 below.
Why does Medi-Cal's CGT Access Model begin with a focus on SCD?
Between 50% and 60% of individuals living with SCD have Medicaid coverage (Medi-Cal in California) and the high price of these treatments may strain state Medicaid agencies’ (DHCS in California) budgets. The CGT Access Model will help make it easier for state Medicaid agencies to provide access to CGT medications for eligible individuals with Medicaid.
Can DHCS add or has it already added transfusion-dependent beta thalassemia (TDT) as a condition eligible for treatment under the CGT Access Model?
No, TDT is not included under the CGT Access Model. Under the CMS CGT Access Model, J3392 (Casgevy) and J3394 (Lyfgenia) are carved out of the managed care delivery system when used only for the treatment of sickle cell disease (SCD). Thus, Medi-Cal managed care plans (MCPs) are not directly billed and are not responsible for payment for these drugs when used for SCD. For all other non-SCD drug indications, including TDT, J3392 (Casgevy) and J3394 (Lyfgenia) remain the responsibility of Medi-Cal MCPs. This will be clarified in the Medi-Cal Provider Manual.
Will the CGT Access Model be expanded in the future to include other diseases beyond SCD?
While the initial focus of the model is on SCD, CMS may choose to expand the CGT Access Model to include other rare and severe conditions in the future; however, DHCS is not aware of any expansions at this time.
What drugs will be covered under Medi-Cal’s CGT Access Model?
Medi-Cal’s CGT Access Model will cover the two federal Food and Drug Administration (FDA)-approved CGT medications identified by CMS for treatment of SCD. This includes, CASGEVY™, which is made by Vertex Pharmaceuticals, Inc., and LYFGENIA™, which is made by bluebird bio, Inc.
What does a typical member’s CGT treatment journey look like?
- A member’s journey receiving CGT treatment may include the following:
- Consultations with hematologists and other specialists
- Comprehensive evaluation at the treatment center including physical needs, behavioral health needs, and social support needs
- Coordination of care and supportive services for members and families navigating the treatment process
- Disease management in preparation for CGT
- Fertility preservation services
- Gene therapy infusion and recovery services
- Post-treatment follow-up care
Benefits
What benefits and services are covered under Medi-Cal’s CGT Access Model?
Under the CGT Access Model, the following costs are covered:
- One of the two CGT medications for SCD
- CASGEVY by Vertex Pharmaceuticals, Inc. - effective September 1, 2025, subject to final CMS approval
- LYFGENIA by bluebird bio, Inc. - effective July 1, 2025, as approved by CMS
Fertility Preservation Services - As part of the reimbursement for the CGT SCD medications, providers cover:
- Up to three rounds of reproductive material collection and preservation, up to fifteen years of storage for eligible members.
- Qualifying lodging, meals, and travel expenses may also be covered, if necessary to receive fertility preservation services.
What benefits and services are not included within the Medi-Cal’s CGT Access Model?
The following other medical and non-medical services are not covered under the CGT Access Model but must be provided and covered depending on the member’s eligibility and enrollment in either the Medi-Cal FFS or managed care delivery system:
Medi-Cal FFS: - FFS providers must deliver and bill DHCS directly for all other medical and non-medical CGT-related services, including transportation (outside of the cost of the drug, fertility preservation, and qualifying lodging, meals, and travel expenses necessary to receive fertility preservation services as noted above).
Medi-Cal Managed Care:
- The member’s Medi-Cal managed care plan must cover all other medical and non-medical CGT-related services, including transportation (outside of the cost of the drug, fertility preservation, and qualifying lodging, meals, and travel expenses necessary to receive fertility preservation services, as noted above).
Where do members receive CGT SCD treatments?
CGT SCD treatments are only available and administered at medical centers that have the appropriate clinical experience and training to do so.
- For LYFGENIA, members receive services from Qualified Treatment Centers (QTCs). There are currently eight (8) QTCs in California. For more information, please visit LYFGENIA’s website.
- FOR CASGEVY, members receive services from Authorized Treatment Centers (ATCs). There are currently six (6) ATCs in California. For more information, please visit CASGEVY’s website.
For more information, please refer to the Member FAQ for more information.
Eligibility
Who is eligible to participate in Medi-Cal’s CGT Access Model?
To be eligible for Medi-Cal's CGT Access Model, Medi-Cal members must meet all of the following criteria:
- Have a documented medical diagnosis of SCD;
- Be actively enrolled in full-scope Medi-Cal at the time the CGT medication is received (note: both Medi-Cal managed care and fee-for-service (FFS) members may be eligible for CGT therapies);
- Have Medi-Cal as their primary payer;
- Receive one of the two CGT medications from a participating provider; and
- Satisfy all CGT Access Model requirements as well as published Medi-Cal policy, as outlined in the Medi-Cal Provider Manual and applicable All Plan Letter .
How do you access CGT medications under Medi-Cal’s GCT Access Model?
Medi-Cal FFS members should consult their treating health care provider to determine eligibility and learn more as well as for information on accessing CGT SCD medications. Medi-Cal FFS providers can assist members with accessing one of the two CGT SCD medications. Medi-Cal managed care members should contact their treating health care provider or Medi-Cal managed care plan (MCP) to determine eligibility and learn more about CGT services. Medi-Cal MCPs are responsible for care coordination and assisting members with accessing one of the two CGT sickle cell disease medications. For more information on Medi-Cal MCP care coordination and other requirements, please review the applicable All Plan Letter on DHCS’ website. Each Medi-Cal MCP also includes a point of contact, which can be found in the Medi-Cal Managed Care Health Plan Directory.
Contact Information & Feedback
Where can you learn more about Medi-Cal’s CGT Access Model and/or provide feedback?
Information about Medi-Cal’s CGT Access Model is available on DHCS’ website, which is available at the following link: Feedback, questions, and comments may also be submitted to DHCS via email at dhcscgt@dhcs.ca.gov.
