Jason Shafrin
One approach CMS has is the Cell and Gene Therapy (CGT) Access Model. Under the CGT Access Model, CMS (at the federal level) will negotiates outcomes based agreements (OBAs) with manufacturers, which will include pricing terms and outcomes to be evaluated. Then states can elect to participate in the contract terms negotiated by CMS or they can opt out and negotiate on their own. From CMS’s perspective, they are hoping that the increased purchasing power will lead to lower prices (or equivalently, more negotiated rebates). For manufacturers, they are hoping that the CGT access model will expedite access for patients and reduce transaction costs since manufacturers would have to negotiate with much fewer than 50 State Medicaid Agencies. For both parties, outcomes-based contracts are burdensome to implement; having CMS will support …
