Press Releases

Washington, D.C. - Today, Representatives Brad Wenstrup (R-OH) and Suzan DelBene (D-WA), along with Representatives Bilirakis (R-FL), Cárdenas (D-CA), Moore (R-UT), Sewell (D-AL), Guthrie (R-KY), and Eshoo (D-CA), introduced the Ensuring Patient Access to Critical Breakthrough Products Act of 2023, legislation that would provide Medicare beneficiaries with faster access to Food and Drug Administration (FDA)-approved breakthrough medical devices.

If enacted, this bill would require Medicare to temporarily cover breakthrough products for four years while the Centers for Medicare & Medicaid Services (CMS) would be required to make a permanent coverage determination. The FDA can give "breakthrough designation" to new medical devices for several reasons, such as: the devices are more effective than alternatives, they offer significant advantages over alternatives, there are no approved alternatives, or the device provides care for a diagnosis of life-threatening or debilitating diseases or conditions. By expediting the coverage determination process for FDA-approved breakthrough devices, this bill removes unnecessary barriers that prevent seniors from accessing the most innovative and cutting edge treatments.

"Seniors should be able to access the most innovative care and breakthrough devices as soon as we know these are deemed safe and effective by the FDA. They should not have to wait years for a Medicare coverage decision on life-saving treatments," said Rep. Wenstrup. "With this legislation, millions of seniors could live longer, healthier lives, and companies that develop these innovative treatments would be supported in their investment in medical technologies and devices."

"Seniors should not be forced to wait years for cutting-edge, safe, and effective treatments that could change or even save their lives," said Rep. DelBene. "Guaranteeing Medicare coverage of breakthrough medical devices would encourage future innovation and investment in next-generation medical technologies while improving the quality of life for millions of seniors. We can’t let the coverage approval process be a barrier to life-saving treatments or care."

The text of the legislation can be found here.

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