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In Brief: Investigational device Medicare coverage

This article was originally published in The Gray Sheet

Executive Summary

Investigational device Medicare coverage: FDA categorizes 1,031 out of 1,101 (93.6%) devices involved in ongoing investigational device exemption-approved clinical trials as "non-experimental" and thus eligible for Medicare reimbursement under a final rule published by HCFA in the Sept. 19 Federal Register ("The Gray Sheet" Sept. 18, p. 2). Under the rule, which went into effect Nov. 1, FDA is forwarding to HCFA the determinations as to whether devices used in IDE trials are "experimental" or "non-experimental." To ensure sponsors' confidentiality, FDA is releasing only IDE numbers along with a categorization decision. However, InterVentional Technologies announced Nov. 1 that its Barath surgical dilatation balloon catheter, which is involved in trials comparing restenosis rates with conventional percutaneous transluminal coronary angioplasty ("The Gray Sheet" July 18, 1994, In Brief), has been categorized as non-experimental...

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