CMS’s controversial decision to restrict access to Alzheimer’s mAb treatments, including Aduhelm, approved under FDA’s accelerated pathway was a unique case that is unlikely to set a precedent, former CMS CMO Lee Fleisher told BioCentury. “I do not think this will be repeated,” he said. In an interview with The BioCentury Show's Steve Usdin, Fleisher gives a behind-the-scenes account of the decision-making process, including the role of accelerated approval. He also discusses the opportunities and risks for healthcare posed by AI, and the scientific and legislative steps that will be needed to make real the promise of blood-based multicancer detection technologies.

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00:00 - Introduction
01:31 - Behind the Aduhelm Decision
08:01 - Questioning CMS
17:19 - Accelerated Approval
26:34 - AI in Medicine