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CMS Delays New Rule Providing Automatic Medicare Coverage of Breakthrough Devices

by | May 10, 2021

A CMS final rule providing for automatic Medicare coverage for new medical products cleared by the FDA as breakthrough devices under Section 510(k) was supposed to take effect on March 15, 2021. But now that CMS is under new management, the rule has been put on ice for at least 60 days pending further study. […]

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