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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.
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