Senate bill looks to streamline CMS pathway for “breakthrough” devices



The U.S. Senate has introduced a bill to expedite Centers for Medicare and Medicaid Services decision making for new medical devices.

The bill, titled the “Ensuring Patient Access to Critical Breakthrough Product Act” will help “bridge a gap” between the FDA and CMS and “improve patient access to breakthrough medical technologies,” according to a new report from medical device industry group Advamed.

“Currently, FDA has an established process to provide priority review to breakthrough technologies. We support reforms to that process in other pending legislation. However, there is no similar process at CMS to ensure patients have access to these devices and diagnostics in a timely manner. So, after FDA determines a breakthrough technology is safe and effective, sometimes it is years later before patients have access to it because of coverage and reimbursement delays at CMS. Medicare beneficiaries deserve better,” Advamed CEO Scott Whitaker said in a press release.




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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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