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​​​​Cell and Gene Therapy Access Model  

Background 

The Department of Health Care Services (DHCS) applied for participation in the federal Centers for Medicare and Medicaid Services’ (CMS’) Cell and Gene Therapy (CGT) Access Model on March 11, 2025. DHCS received formal approval from CMS and was accepted into the CGT Access Model for Medi-Cal as of March 25, 2025.  

This model aims to improve and streamline ACC​ess 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. In alignment with CMS requirements, the initial focus of the CGT Access Model will be on providing coverage for cell and gene therapies specifically approved for the treatment of sickle cell disease for Medi-Cal members. This includes the following therapies: 
  • 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 
By promoting better access to these CGT medications, Medi-Cal members are expected to experience improved health outcomes and quality of life. DHCS expects that additional CGT medications for other rare and severe diseases may be added over time and policies would then be updated accordingly.  
Medi-Cal Member’s CGT Treatment Journey 
A member’s journey receiving treatment may inclu​de 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 and Services Covered Under the 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 Bluebir​d bio, Inc. - effective July 1, 2025, as approved by CMS 
  • Fertility Preservation Services 
    • Drug manufacturers 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.   

CGT Access Model Eligibility 

To be eligible for Medi-Cal’s CGT Access Model, Medi-Cal members must have a documented medical diagnosis of SCD, be actively enrolled in Medi-Cal at the time therapy is received, have Medi-Cal as their primary payer, receive one of the two CGTs from a participating provider, and meet published Medi-Cal policy and all CGT Access Model requirements. For more information, please refer to Medi-Cal’s coverage and reimbursement policy. 

Accessing CGT Treatments 

Medi-Cal FFS: 
  • ​Medi-Cal FFS members should consult their treating health care provider for information on CGT eligibility and obtaining CGT therapies under Medi-Cal’s CGT Access Model. 
Medi-Cal Managed Care: 
  • ​​Medi-Cal managed care members should consult their treating provider or reach out to their assigned Medi-Cal managed care plan (MCP) for more information about CGT medications available under Medi-Cal’s CGT Access Model.  
  • ​Medi-Cal MCPs are responsible for care coordination and assisting their 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 includes a point of contact for general inquiries, which can be found in the Medi-Cal Managed Care Health Plan Directory.  
  • Please note that the two CGT medications covered through Medi-Cal’s CGT Access Model are “carved out” of the Medi-Cal MCP contracts, which means they are not provided by Medi-Cal MCPs but are instead provided by Medi-Cal FFS providers who may or may not be part of a Medi-Cal MCP’s network and are directly billed directly to and paid for by DHCS.  ​



Last modified date: 7/3/2025 1:39 PM