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Abstract
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). "Medicare may make payment for an investigational device and routine care items and services furnished in an FDA-approved Category B (Nonexperimental/Investigational) IDE study if CMS (or its designated entity) determines, prior to the submission of the first related claim, that the Medicare coverage IDE study criteria in 42 CFR 405.212 are met. Devices that fall into Category B include those that: are approved but have insertion systems that have been modified to improve ease of use for the clinician; are approved but have been modified to improve performance; are new and will be studied for an indication for which safety and effectiveness information exists from other similar devices; are shown to answer initial questions of safety and effectiveness; are approved but will be evaluated for a new indication; will be evaluated in a new patient population; and for which new device sizes will be added to a product matrix for an approved device.