Makers of innovative medical devices makers will remain on pins and needles after CMS’s decision to once more delay a final rule that would automatically provide initial Medicare coverage for new medical products cleared by the FDA as breakthrough devices under Section 510(k). Finalized during the Trump administration, the rule is a long-term project that…
Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices
Makers of innovative medical devices makers will remain on pins and needles after CMS’s decision to once more delay a final rule that would automatically provide initial Medicare coverage for new medical products cleared by the FDA as breakthrough devices under Section 510(k). Finalized during the Trump administration, the rule is a long-term project that […]
