“Breakthrough” medical technologies treat life-threatening or irreversibly debilitating conditions for which there are no treatments or for which existing treatments are lacking. In other words, breakthrough technologies are a beacon of hope for seniors suffering from terrible, often untreatable conditions.

The Biden Administration is considering rescinding a rule, entitled Medicare Coverage of Innovation Technology (MCIT) that has received bipartisan support in Congress. Under this rule, if the FDA approves a breakthrough technology, Medicare can quickly cover it, assuring immediate national coverage of devices for seniors in need of lifesaving treatments.

MCIT ensures the safety and efficacy of breakthrough technologies. After receiving breakthrough designation, these technologies must still undergo the rigorous FDA review process – the global gold standard for medical safety and effectiveness – to achieve approval. Medicare coverage of breakthrough technologies under MCIT is temporary, allowing for the ongoing collection of data to better understand the impact of these technologies.

What we’re saying is simple, and it’s good government, and it’s good common sense: Medicare beneficiaries deserve access to truly breakthrough technologies, as soon as possible.

“This crucial change to federal law will leave the decision about whether a breakthrough medical technology is right for your grandfather precisely where it belongs: between your grandfather and his doctor.”

––Scott Whitaker, AdvaMed CEO, in Morning Consult


Did you know?

More than 400 medical devices have received the FDA “breakthrough” designation.

MCIT would not be cost prohibitive

FDA-designated breakthrough devices have been sufficiently tested

MCIT will ensure that medical treatments covered by Medicare will treat conditions in a cost-effective manner

MCIT has received bipartisan support in Congress and has been a priority of AdvaMed’s and the medical device industry for years

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