Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite broad support.
The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Medicare Coverage of Innovative Technology (MCIT) in January, granting coverage for breakthrough devices the same day as their FDA approvals, for up to four years.
Immediately upon taking office, the Biden administration asked federal agencies to consider delaying the effective date of rules published in the Federal Register to review questions of fact, law and policy the rules may raise. CMS officials decided that coverage of breakthrough devices warranted further review.
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