The Centers for Medicare and Medicaid Innovation (CMMI) previously released three new payment models, all aimed at lowering drug costs. One of those models, the Cell and Gene Therapy (CGT) Access Model, has now been developed and greater detail provided about what to expect. The CGT Access Model will focus on improving health outcomes for Medicaid beneficiaries who could benefit from cell and gene therapies by supporting outcomes-based agreements between individual states and manufacturers that will provide for treatments within a framework that lowers prices for states and ties payments to outcomes. The framework is intended to make it easier for states to pay for cell and gene therapies. The model will initially focus on the “historic disparities, poor health outcomes, and low life expectancy associated with sickle cell disease,” though other conditions may be added to the model over time.
The CGT Access Model is a “multi-year voluntary model for states and manufacturers” and the Centers for Medicare and Medicaid Services (CMS) expects states to begin with a rolling start in January 2025. A Request for Application (RFA) to manufacturers will likely be released in Spring 2024 and an RFA and Notice of Funding Opportunity (NOFO) to states will be issued in Summer 2024.
Under the CGT Access Model, CMS and pharmaceutical manufacturers will work together to negotiate a set of key terms, including pricing and outcome measures that will form the basis for individual contracts between the manufacturers and participating states. If State Medicaid agencies sign the negotiated contract, manufacturers would then be obligated to provide estates with supplemental rebates that reflect the terms of the agreement and states will be obligated to implement an agreed-upon standard access policy. For its part, CMS will provide technical assistance and funding to participating states. The outcome based agreements will also include additional sources of savings, including pricing concessions and/or rebates tied to volume.
CMS notes that the Model will initially focus on Medicaid patients who receive gene therapy for sickle cell disease in a participating state. Patients receiving gene therapy for sickle cell disease will need to go through an extended inpatient hospital stay and possibly additional visits to a gene therapy center. The process of preparing for gene therapy often also involves myeloablative chemotherapy, which often results in infertility in the patient. Therefore, the model will also include “coverage of a defined scope of fertility preservation services and supports for ancillary services, including travel expenses, case management, and behavioral health services.”
To qualify for gene therapy to treat sickle cell disease under the CGT Access Model, a person must have a documented medical diagnosis for sickle cell disease and be enrolled in Medicaid or CHIP in a state participating in the model at the time of therapy (with Medicaid as the primary payer). Additionally, they must receive a gene therapy from a participating manufacturer and meet standardize prior authorization criteria as established.
“Gene therapies for sickle cell disease have the potential to treat this devastating condition and transform people’s lives, offering them a chance to live healthier and potentially avoid associated health issues,” said CMS Administrator Chiquita Brooks-LaSure. “Increasing access to these promising therapies will not only help keep people healthy, but it can also lead to savings for states and taxpayers as the long-term costs of treating sickle cell disease may be avoided.”
For more information, see the CGT Access Model Fact Sheet here, CGT Access Model FAQs here, and a CGT Access Model Infographic here.
CMS also notes that while providers will not be formal participants in the Model, they will play “an important role in delivering care and submitting data.”