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Medicare coverage of investigational devices with "incremental risk" to begin Nov. 1.

This article was originally published in The Gray Sheet

Executive Summary

MEDICARE COVERAGE OF INVESTIGATIONAL DEVICES PRESENTING "INCREMENTAL RISK" relative to an approved device will begin Nov. 1, 1995. Faced with pressure from Capitol Hill, the medical device and hospital industries, and physicians, HCFA plans to issue a final rule in the Sept. 19 Federal Register that partially reverses its policy of refusing to pay for unapproved devices in investigational device exemption trials. There will be a 60-day comment period on the final rule.
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