WASHINGTON, D.C. — A bipartisan group of lawmakers, including Representatives Brad Wenstrup (R-OH) and Suzan DelBene (D-WA), introduced a new bill today that aims to provide Medicare beneficiaries with faster access to Food and Drug Administration (FDA)-approved breakthrough medical devices. The bill called the Ensuring Patient Access to Critical Breakthrough Products Act of 2023, would require Medicare to temporarily cover breakthrough products for up to 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 their effectiveness, significant advantages over alternatives, or providing care for life-threatening or debilitating diseases or conditions. The bill would expedite the coverage determination process for FDA-approved breakthrough devices, which removes unnecessary barriers that prevent seniors from accessing innovative 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.”
Rep. DelBene added, “Seniors should not be forced to wait years for cutting-edge, safe, and effective treatments that could change or even save their lives…We can’t let the coverage approval process be a barrier to life-saving treatments or care.”
The bill has garnered support from other Representatives including Bilirakis (R-FL), Cárdenas (D-CA), Moore (D-WI), Sewell (D-AL), Guthrie (R-KY), and Eshoo (D-CA).
