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January 12, 2021

AdvaMed Praises Expanded Coverage of FDA-Designated “Breakthrough” Medical Technologies for Medicare Beneficiaries

New Medicare Coverage Pathway—Medicare Coverage of Innovative Technology (MCIT)—Offers Hope to Our Seniors

 

WASHINGTON, D.C. – Today, AdvaMed President and CEO Scott Whitaker commended CMS on the rule the agency released today establishing a new coverage pathway – MCIT – for breakthrough medical technologies:

“Too many of our seniors are afflicted by conditions for which no treatment options exist. From heart failure to cancer, from Alzheimer’s to diabetes, too many are suffering with ailments that actually could be treated with next-generation care. Today’s announcement by CMS Administrator Verma will help ensure Medicare beneficiaries will benefit from breakthrough technologies. On behalf of our industry and the potentially millions of seniors who stand to benefit from these lifechanging innovations, we applaud the Adminstrator’s leadership and thank her and her team for taking this important step forward.

“Under the new MCIT rule, as soon as the FDA approves a new breakthrough technology, Medicare can cover that breakthrough technology. It’s that simple – and it should be that simple. It means that when a device or diagnostic test that is designated as a breakthrough and determined by the FDA to be safe and effective, Medicare patients can be the first in line to get it when their doctors determine it is necessary.   

“It’s good government, and it’s good common sense to recognize that if doctors and scientists at the FDA – the global gold standard for medical technology regulation – determine a device is safe and effective, another federal agency can then move quickly to ensure patients can access that lifechanging and often lifesaving technology. We urge the incoming administration to keep this important step forward for our seniors in place, and we look forward to working closely with them on its implementation.”

Under the final rule, CMS will provide immediate national coverage for four years for any new device or diagnostic designated as a breakthrough technology and deemed safe and effective by FDA. During that four-year coverage period, CMS would specify what additional data, if any, would be needed to maintain coverage after the four-year coverage period expires.

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.