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BioWorld - Sunday, February 15, 2026
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Home » Existing authorities are adequate for breakthrough device coverage in U.S.
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2021 Medtech Conference

Existing authorities are adequate for breakthrough device coverage in U.S.

Sep. 28, 2021
By Mark McCarty
The demise of the Medicare Coverage of Innovative Technologies (MCIT) rule may not be the end of the breakthrough devices coverage story, but Lee Fleisher of the U.S. Centers for Medicare & Medicaid Services (CMS) said the MCIT rule was riddled with deficiencies. Fleisher said CMS is of the view that expedited coverage of breakthrough medical devices would be better handled under existing statutory authorities, suggesting the agency sees no need for the MCIT-driven provisions of the Cures 2.0 legislation.
Medical technology U.S. CMS FDA

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