MCIT Comments: Threading the Needle on Speed vs. Evidence Checks

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As CMS moves toward repealing the Trump-era Breakthrough Device expedited coverage plan, industry groups and others float alternatives they hope will help address the agency’s worries about lack of evidence in the Medicare population without fully mimicking current time-intensive pathways.

Device firms and some independent health policy groups are proposing a more defined application process as an entry point for expedited Medicare coverage of new technologies.

This would differ from the Medicare Coverage of Innovative Technology (MCIT) finalized in the Trump administration that established automatic (four-year) coverage for FDA-designated Breakthrough Devices on the day of approval when a manufacturer opts in without any requirement for CMS to review evidence. That approach is now untenable, the new CMS leadership made clear in a proposal to repeal MCIT last month. But the agency now says it will work on alternatives in future rulemaking to address coverage gaps following FDA approval of innovative devices. Public comments on the proposed rule were due October 15, providing an opportunity for companies and other interested parties to advocate for specific alternatives.


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