October 28, 2026
The Centers for Medicare and Medicaid Services (CMS) announced that it will be expanding the Cell and Gene Therapy (CGT) Access Model, under which CMS negotiates outcomes-based agreements with CGT manufacturers on behalf of state Medicaid agencies.
Currently, the CGT Access Model only addresses therapies for sickle cell disease. But under the new proposal, this will be expanded to CGTs for a wide variety of health conditions. The agency said this change is being implemented with the intention that the “broadened model would make life-changing therapies more affordable to state Medicaid programs, giving more patients access to treatments they need to live healthier lives.”
In the coming months, CMS will release a Request for Applications to CGT manufacturers, which will allow them to begin negotiations for outcomes-based agreements earlier in the process and offer opportunities to submit therapies for health conditions beyond sickle cell disease.