Medicare Coverage With Evidence Development Mandate Expires After Four Years Under Senate Bill
As CMS brings public attention to process with its national coverage analysis for Alzheimer’s drugs, legislation aims to encourage quick recommendations – and strengthen collaboration with FDA.
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Alliance for Aging Research worries the studies could drag on as long as the nine years Biogen is allowed for collecting Phase IV clinical data on its Aduhelm.
Biogen/Eisai’s newly-approved Alzheimer’s drug could be headed to CMS’ Medicare advisory committee, which is chaired by vocal drug pricing reform advocate Peter Bach.
Manufacturers can apply for permanent Medicare reimbursement codes on a quarterly basis rather than annually going forward to allow for more frequent coding awards. Recently about two dozen drugs, including three biosimilars, received permanent codes earlier than usual.