WASHINGTON, D.C. — The Centers for Medicare & Medicaid Services (CMS) has unveiled a groundbreaking initiative aimed at expanding access to potentially curative gene therapies for individuals with sickle cell disease on Medicaid. The newly launched Cell and Gene Therapy (CGT) Access Model includes 33 states, the District of Columbia, and Puerto Rico—covering approximately 84% of Medicaid beneficiaries diagnosed with the condition.
The CGT Access Model marks a historic shift in how the federal government collaborates with states and pharmaceutical manufacturers. For the first time, CMS will negotiate outcomes-based contracts with cell and gene therapy producers on behalf of participating state Medicaid agencies. The goal: to ensure patient access to life-changing therapies while safeguarding public funds through performance-based pricing agreements.
“This agreement is a major win for American patients and for Medicaid,” said U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. “Thanks to the leadership of Dr. Oz, CMS is making this model a reality. I look forward to seeing states lead the charge to improve health outcomes at lower costs for the American people.”
Sickle cell disease, a genetic blood disorder, often leads to chronic pain, stroke, organ damage, and frequent hospitalizations. Treatment has historically been limited, but recent breakthroughs in gene therapy hold the promise of long-term relief—and possibly cures. However, the prohibitively high cost of these therapies has been a barrier for many state Medicaid programs.
Under the CGT Access Model, CMS will work directly with participating states and manufacturers to establish terms that tie reimbursement to actual health outcomes. If a therapy fails to deliver its expected benefit, the manufacturer will be required to provide discounts or rebates to the Medicaid program.
“This model is a game changer,” said CMS Administrator Dr. Mehmet Oz. “CMS is giving states the tools to deliver lifesaving therapies to patients in need, while holding manufacturers accountable for outcomes and protecting taxpayer dollars.”
To facilitate adoption, CMS is offering participating states up to $9.55 million in federal support for activities such as data tracking, implementation, and community outreach. States may also choose flexible launch dates, starting as early as January 2025 through January 2026.
Abe Sutton, Director of the CMS Innovation Center and Deputy Director of CMS, emphasized the broader vision behind the program. “This is CMS delivering innovation with purpose. By negotiating outcomes-based agreements with drugmakers, we are helping states lead on access, accountability, and affordability simultaneously.”
The CGT Access Model may also pave the way for future Medicaid strategies targeting other high-cost therapies beyond sickle cell disease. CMS has indicated the model could expand to address additional conditions that stand to benefit from emerging biomedical innovations.
The participating jurisdictions include: Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Illinois, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, the District of Columbia, and Puerto Rico.
This federal-state partnership represents a significant stride toward equitable access to next-generation treatments, while demonstrating a pragmatic approach to managing the financial sustainability of public health programs.
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