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Unique Missions Of FDA, CMS Underscored In Presentations To HHS Panel

This article was originally published in The Gray Sheet

Executive Summary

Ongoing attempts to coordinate FDA and CMS reviews will preserve approval, coverage, coding and payment as distinct processes, agency representatives concurred at the HHS Secretary's Advisory Committee on Regulatory Reform regional hearing June 10

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Six Months Sufficient For CMS In-House NCDs – HHS Reg Reform Panel

CMS should impose a six-month timeframe for all in-house national coverage determinations (NCDs) for new technology items, the HHS Secretary's Advisory Committee on Regulatory Reform final report recommends

FDA/CMS collaborative reviews

HHS will implement "promising" recommendations from the Secretary's Advisory Committee on Regulatory Reform, the department pledges in a 1five-year draft strategic plan, comments for which will be accepted through Sept. 9. The plan identifies new medical technology approvals as an area for agency collaboration. The topic has been a priority issue for the HHS panel, most recently during its June meeting in Minneapolis (2"The Gray Sheet" June 17, 2002, p. 3)...

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