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Cell and Gene Therapy Access Model

CMS said October 27 that it plans to broaden its voluntary Cell and Gene Therapy Access Model beyond its initial sickle-cell focus. The agency expects to release a request for manufacturer applications in the coming months and describes negotiating outcomes-based agreements on behalf of participating state Medicaid programs.

Review qualification: The planned expansion is voluntary and prospective; no completed application process or agreement is asserted.

Applicability and suggested action: State Medicaid, specialty pharmacy and payer contracting teams can monitor the future manufacturer application and participation terms and assess potential relevance; no agreement or coverage expansion for additional therapies is established by the announcement.

CMS Innovation Insight

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