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March 16, 2016

AdvaMed Applauds Reps. Young & Peters on Introduction of CMS Clinical Trials Coverage Bill

WASHINGTON, D.C. – JC Scott, senior executive vice president, government affairs, for the Advanced Medical Technology Association (AdvaMed), issued the following statement today following introduction in the House of legislation which will ease Medicare beneficiary participation in medical technology clinical trials:

“AdvaMed commends Reps. Todd Young (R-Ind.) and Scott Peters (D-Calif.) for introducing the Removing Barriers to Clinical Research Act of 2016, which would improve patient access to clinical trials involving innovative medical technologies.

“Currently, patients engaged in FDA-approved pharmaceutical clinical trials are automatically covered by Medicare, while medical technology trials must go through a separate coverage determination at CMS.

“The legislation would eliminate this bureaucratic barrier and allow Medicare patients to more easily participate in clinical trials for medical technology, resulting in greater patient access to new therapies, and lower costs and time associated with conducting these trials.

“CMS’s duplicative approval process is a particular concern for small, start-up companies that often find the bureaucratic hurdles so great that they do not even apply for Medicare coverage.

“We look forward to working with members of Congress, CMS and other key stakeholders to move this important legislation forward.”

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