CMS Delays Breakthrough Coverage Pathway Adoption Until December

The Biden administration announced Friday (May 14) it’s delaying the Trump-era rule on Medicare instantly covering FDA-approved breakthrough devices until Dec. 15 despite a push by medical device makers and lawmakers to implement the pathway as soon as possible. CMS said it shares concerns the new coverage pathway could lead to Medicare covering devices that lack adequate value and safety assessments, and the agency worried it might not be able to pull coverage if a device is later found unsafe...