Provider Notice issued 03/12/2026

Cell Gene Therapy (CGT) Access Model

This notice informs providers that effective January 1, 2026, and at the recommendation of the Advisory Council for Sickle Cell Disease and Other High-Cost Drugs, the Department of Healthcare and Family Services (HFS) is participating in the Cell and Gene Therapy (CGT) Access Model. The administration period of the Model begins January 1, 2026, and continues through December 31, 2030. 

CGT Access Model

Established and operated by the Centers for Medicare and Medicaid Services’ Innovation Center (CMMI), the program will be available for individuals with Medicaid as primary coverage and will be available both under Managed Care Organizations (MCO)  and Fee-For-Service (FFS). This model will assist in addressing access to critical support and services for people with Medicaid in need of these novel therapies. 

The goals of the Model are: 

• Improve patient health outcomes by increasing their ability to receive cell and gene therapies. 

• Test innovative payment arrangements to reduce health care costs and administrative burden for Medicaid programs. 

Presently, CMMI has restricted participation under the Model to the drug indication of Sickle Cell Disease. Participating Model Drugs are limited to: 

• Casgevy (J3392) 

• Lyfgenia (J3394) 

 
Clinical Criteria used to establish “medical necessity” for the purpose of prior authorization under the Model for Lyfgenia and Casgevy can be found at: https://ilpriorauth.com/pages/14 (listed alphabetically by brand name, under individual medications). This criteria applies both to fee-for-service and managed care.

Note: Drugs administered under the Model are not eligible under the 340B Program. 

Provider Expectations and Billing

In addition to normal Medicaid provider requirements, all providers administering a Model Drug under the CGT Access Model must: 

• Hold an agreement with the manufacturer in question, acknowledging authority to administer the therapy 
• Are active members of the Center for International Blood and Marrow Transplant Research (CIBMTR) and participate in CIBMTR’s Research Database study protocol. 

Hospital Billing Instructions 

 Treatment Center Hospitals will bill two separate claims.

Claim 1: 837I Invoice

• Bill the hospital stay for the infusion admission through discharge.
• Exclude CGT Drug, preferably from the claim altogether.  If included on claim, the total charges for the drug must be priced at zero with an informational message.

Claim 2: 837P Invoice

• Provider must bill the CGT drug on the 837P utilizing the hospital’s 40X number.  

• The billed amount should be Actual Acquisition Cost

• Providers should submit the 837P immediately following the completion of the infusion.

• The drugs will be listed on the Practitioner Fee Schedule (PFS), with specific instructions for hospital 40X numbers found in the PFS Key.

   

Questions regarding this notice may be directed to HFS.CGTModel@illinois.gov. For Managed Care plan questions, contact the applicable MCO.

Laura Phelan, Administrator 
Division of Medical Programs