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BioWorld - Monday, December 15, 2025
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Home » US House resurrects bill for Medicare coverage of breakthrough devices
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US House resurrects bill for Medicare coverage of breakthrough devices

March 29, 2023
By Mark McCarty
The controversy over U.S. Medicare coverage of breakthrough devices is far from over as an administrative matter, but the House of Representatives is prepared to statutorily force the issue with a new bill that enjoys bipartisan support. The Ensuring Patient Access to Critical Breakthrough Products Act of 2023 provides instant Medicare coverage upon FDA clearance or approval of the device, a feature of previous policy proposals that the CMS has found administratively problematic.
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