FDA Clarifies IDE Categories For Medicare Coverage, CMS Won't Cover Cleared Devices When Drugs Added

FDA published final guidance Monday (Dec. 4) aimed at helping CMS determine which investigational devices to cover by streamlining the categorization of investigational device exemption (IDE) products -- completing a process launched in 2015 through a Memorandum of Understanding (MOU) between FDA's device center and CMS' Coverage and Analysis group (CAG). In a blow to a coalition of device makers, the guidance says that when a drug is added to a previously approved or cleared device, the product in the...