We have serious concerns about CMS’s draft national coverage determination (NCD) – issued January 11, 2022 – to limit Medicare coverage for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease (AD) to patients enrolled in qualifying clinical trials. If finalized, the NCD, which would restrict access to an FDA-approved treatment to a select few patients, would be an unprecedented and unnecessary overreach on the part of CMS. In addition, the restrictions imposed by the NCD do not reflect the realities faced by the AD patient community. Finally, by imposing strict coverage limitations on emerging therapies, we believe the decision would stifle future innovations and delay much needed advancements in AD treatments.
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