ARM welcomes the release of the Center for Medicare and Medicaid Innovation’s (CMMI) Cell and Gene Therapy Access Model

Washington, DC – January 31, 2024

The Alliance for Regenerative Medicine (ARM) welcomes the release of the Center for Medicare and Medicaid Innovation’s (CMMI) Cell and Gene Therapy Access Model.

The voluntary model recognizes that transformative, durable, and potentially curative gene therapies require innovative thinking about access, payment, and healthcare delivery. Patients with severe sickle cell disease should have timely access to life-changing gene therapies regardless of their income level, where they get their health coverage, or where they live.

Medicaid is a critical source of healthcare coverage for 88 million Americans. The CMMI model is a step toward modernizing how Medicaid pays for medicine and to addressing barriers that have prevented or delayed access to approved cell and gene therapies (CGTs). It provides an opportunity for the Center for Medicare and Medicaid Services (CMS), state Medicaid programs, and biotechnology companies to collaborate to improve healthcare outcomes and reduce disparities in care for communities of color.

Outcomes-based models are an important but complex tool that can be difficult to implement. If CMS and participating biotechnology companies can successfully negotiate standardized outcomes-based agreements, and states agree to uniform access terms, more Medicaid patients could benefit from therapies that can transform their health and quality of life.

The model’s initial scope is limited by design and does not begin until January 2025. But, if successful, it could serve as a roadmap for voluntary payment and coverage agreements that promote equitable access to CGTs for other patient populations across multiple states. In the meantime, states should pursue all available options to ensure access to CGTs today. ARM urges CMS to consider more comprehensive policy initiatives to protect all Medicaid and Medicare beneficiaries’ access to CGTs, and to refrain from implementing proposed changes to the Medicaid Drug Rebate Program that undermine the very intent of the CGT Access Model.