Gottlieb: CMS Will Cover Diagnostic Tests That Voluntarily Gain FDA Approval

FDA and CMS will increasingly work together on simultaneous diagnostic test reviews, a move that FDA Commissioner Scott Gottlieb told lawmakers Thursday (Dec. 7) could serve as “a powerful incentive” for more sponsors of diagnostic tests to voluntarily go through the FDA approval process. The statement, at a Senate health committee hearing on 21st Century Cures Act implementation, came in response to a question from Sen. Michael Bennet (D-CO), who brought up FDA and CMS' Nov. 30 announcement that CMS...