IDE Medicare reimbursement categorization for ongoing studies to be completed by Oct. 6 -- FDA.
This article was originally published in The Gray Sheet
Executive Summary
IDE MEDICARE REIMBURSEMENT: RE-EVALUATION REQUESTS REQUIRE IDE SUPPLEMENTS, FDA says in a Sept. 15 "blue book" memo outlining the agency's responsibilities for implementing an interagency agreement with the Health Care Financing Administration for Medicare reimbursement of investigational devices. For devices initially designated "Category A experimental ," which are not eligible for Medicare coverage, sponsors are directed to submit a written request for re-evaluation in the form of an investigational device exemption supplement to the appropriate division within FDA's Office of Device Evaluation.