Press Releases

WASHINGTON, DC – Yesterday, the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act, introduced by Representatives Lori Trahan (D-MA-03), Blake Moore (R-UT-01), Suzan DelBene (D-WA-01), Rudy Yakym (R-IN-02), Terri Sewell (D-AL-07) and Gus Bilirakis (R-FL-12), passed the House Ways and Means Committee by a bipartisan vote of 38-3. The bill will expand access to breakthrough medical devices for Medicare patients and create a streamlined pathway for FDA-designated breakthrough devices to receive transitional Medicare coverage while CMS conducts a review for a permanent coverage determination.

“When the FDA determines a breakthrough medical device is safe and effective, patients shouldn’t have to wait years to benefit from it,” Congresswoman Trahan said. “Too often, seniors are left in limbo after FDA approval while Medicare coverage catches up. The Ensuring Patient Access to Critical Breakthrough Products Act fixes that gap – ensuring that the most innovative, lifesaving devices get to the people who need them most, when they need them most.”

“There is no reason that Medicare patients should have to wait to access breakthrough medical devices already cleared by the FDA. This legislation ensures patients receive the most advanced treatments on the market as soon as possible,” Congressman Moore said. “Easing the pathway for Medicare approval has been a priority of recent administrations, and I am proud that my colleagues and I were able to work together to help open the door for enhanced access to medical innovations.”

“Too often, outdated policies stand between patients and the treatments they need,” Congresswoman DelBene said. “The Ensuring Patient Access to Critical Breakthrough Products Act will modernize Medicare coverage so that when the FDA approves a safe and effective device, seniors can benefit without unnecessary delays. This legislation strengthens access to care, supports American innovation, & helps ensure Medicare keeps pace with today’s medical advances.”

“When a medical device is proven safe and effective, patients shouldn’t have to wait years to access it,” Congressman Yakym said. “This bill ensures that seniors on Medicare can benefit from FDA-designated breakthrough devices right away, while creating a clear path for continued coverage. It’s about cutting red tape, speeding access, and giving hope to those facing serious illnesses. Seniors deserve timely access to the best treatments available, especially when no other options exist.”

“This legislation will help millions of seniors on Medicare by ensuring more timely access to the treatments they need,” Congressman Bilirakis said. “Additionally, there are more than 600 medical device companies in our state working to develop innovative and effective products. I've heard from many of these businesses about how these lengthy and unnecessary Medicare coverage delays create a significant barrier in bringing new products to market. This bill is about connecting patients with important devices and technologies quicker. Additionally, it is about encouraging innovation rather than stifling it. Government has to get out of the way and streamline the payment process for effective new devices that can ultimately help improve and save lives.”

Despite receiving FDA breakthrough designation, innovative medical devices face a significant hurdle in gaining Medicare coverage. This delay, often referred to by innovators as the “valley of death,” can last up to five years, hindering patient access to crucial treatments.

The Ensuring Patient Access to Critical Breakthrough Products Act addresses this issue by establishing a clear, expedited pathway. Upon a manufacturer's application, the bill provides four years of transitional Medicare coverage for breakthrough devices. During this temporary period, the Centers for Medicare & Medicaid Services is mandated to make a permanent coverage determination. This legislative measure aims to encourage the market entry of more innovative medical devices and ensure quicker access to these treatments for Medicare patients.

The text of the legislation can be found HERE.

###