Cell and Gene Therapy Access Model Coverage Criteria

The Center for Medicare and Medicaid Innovation (CMMI) Cell and Gene Therapy Access Model supports Medicaid program coverage of selected therapies. State participation in the model requires the Michigan Department of Health and Human Services (MDHHS) to publish prior authorization coverage criteria for selected therapies. 

Prior authorization requests for these cell and gene therapies must be submitted to MDHHS for Medicaid Health Plan (MHP) enrollees and Fee-for-Service (FFS) beneficiaries. Prior authorization requests for the admission and/or services associated with the administration of gene therapies, where applicable, are to be submitted to the MHP for MHP enrollees and to MDHHS for FFS beneficiaries. 

Medical necessity is established by meeting the coverage criteria. MDHHS will continue to consider prior authorization requests for beneficiaries that may not meet all criteria or for additional indications beyond the scope of the model. Medical necessity determinations are not a guarantee of beneficiary eligibility or payment. Providers must adhere to all applicable Medicaid policies and procedures, including prior authorization submission and documentation requirements. Additional guidance on documentation is available at Fee-for-Service Medicaid Prior Authorization Guidelines.

• CASGEVY (exagamglogene autotemcel)
• LYFGENIA (lovotibeglogene autotemcel)

For more information about program coverage and submitting requests for prior authorization refer to the General Information for Providers chapter in the MedicaidProviderManual.pdf.

For more information about the Cell and Gene Therapy Access Model refer to CGT (Cell and Gene Therapy Access) Model | CMS).