CMS delays rule for breakthrough medical technologies for 2nd time

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CMS further delayed a final rule that aims to speed up FDA approval for Medicare coverage of breakthrough medical devices and technologies.

The Medicare Coverage of Innovative Technology rule will be delayed until Dec. 15. CMS made the announcement in an interim final rule scheduled to be filed in the federal register May 18. 

The second delay will provide "CMS an opportunity to address all of the issues raised by stakeholders, especially Medicare patient protections, evidence criteria and lack of coordination between coverage, coding and payment as noted previously," CMS wrote in the interim final rule.

The rule was initially delayed by the Biden administration in March. The Biden administration postponed the effective date to May 15 as part of its strategy to review policies released toward the end of former President Donald Trump's term.

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