Tunis: Congress Should Clarify CMS’ CED Policy, Give CMS More Tools

Former CMS official and FDA adviser Sean Tunis said Congress needs to work on legislation that provides CMS with the tools it needs to make coverage decisions for innovative technologies and breakthrough therapies and that sets up an Office of the Chief Scientist at the agency to coordinate discussions with FDA. Tunis made the comments two days before CMS decided to cover Biogen’s pricey and controversial Alzheimer’s drug Aduhelm (aducanumab) using a rarely used coverage with evidence development policy that...