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Sickle Cell Gene Therapy Makers Would Pay For Fertility Services In Medicaid Payment Model

 
• By Cathy Kelly

The manufacturer requirement, which invokes CMMI’s safe harbor authority, could help overcome some barriers to access that the companies are facing in Medicaid outside of the demonstration. 

• Source: Shutterstock

Vertex Pharmaceuticals Incorporated and bluebird bio would fund fertility preservation services for patients treated with their gene therapies for sickle cell disease under the Center for Medicare and Medicaid Services Innovation’s Medicaid payment demonstration if they choose to participate.

Key Takeaways

  • Vertex and bluebird bio will be allowed to pay for fertility preservation services for sickle cell disease patients who are administered gene therapy under the new CMMI demonstration, according to a request for proposals from the agency.

  • The companies have so far been unsuccessful in seeking a federal government advisory opinion concluding such support provided to Medicaid patients outside the demonstration does not violate anti-kickback laws

CMMI discussed fertility preservation and other aspects of manufacturer participation in its proposed Cell & Gene Therapy Access Model in a recently-released request for applications

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