Source: United States House of Representatives – Representative Gus Bilirakis (FL-12)
Washington, D.C. — Earlier this week, U.S. Representatives Gus Bilirakis (R-FL), Blake Moore (R-UT), Suzan DelBene (D-WA), Rudy Yakym (R-IN), Terri Sewell (D-AL), and Lori Trahan (D-MA) reintroduced the Ensuring Access to Critical Breakthrough Products Act, legislation aimed at improving access to cutting-edge medical technology for America’s seniors. The bill would require Medicare to provide coverage for medical devices approved under the FDA’s Breakthrough Devices Program, which is designed to accelerate the development and review of innovative technologies that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. Currently, Medicare does not automatically cover these breakthrough medical technologies—even when they have been approved or cleared by the FDA and granted breakthrough designation. Under the traditional process, it can take more than six years for Medicare to determine coverage, delaying access to potentially life-saving treatments for millions of seniors.
“This legislation will help millions of seniors on Medicare by ensuring more timely access to the treatments they need,” said Congressman Bilirakis. “Florida is home to over 600 medical device companies that are working every day to develop innovative, effective products. I’ve heard directly from many of these companies about how outdated and unnecessarily long Medicare coverage delays pose a major barrier to bringing new devices to market.
Immediately upon its reintroduction, the legislation was reviewed and reported favorably by the House Ways and Means Committee.
“This bill is about getting breakthrough medical technologies into the hands of patients faster. It’s about removing bureaucratic red tape and encouraging innovation—not stifling it. The government must streamline the coverage process for effective new devices that can improve health outcomes and save lives,” Bilirakis added.
“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,” Rep. 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,” Rep. 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,” Rep. 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.”
“When the FDA determines a breakthrough medical device is safe and effective, patients shouldn’t have to wait years to benefit from it,” Rep. 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.”
Background: In 2016, the 21st Century Cures Act created a new pathway for “breakthrough” medical devices to receive expedited Food and Drug Administration (FDA) approval. To be eligible for the Breakthrough Devices Program, the device must utilize novel technology to treat a condition that has no other approved alternatives or the device’s technology provides a significant benefit above existing therapies. Receiving Medicare coverage following an FDA breakthrough designation remains a barrier. Innovators often call the lag time between FDA clearance and Medicare coverage the “valley of death,” as devices wait up to five years for Medicare coverage. In January 2021, the Trump Administration finalized the Medicare Coverage of Innovative Technology (MCIT) rule, which created a pathway for breakthrough devices to receive automatic Medicare coverage in a transitional period while awaiting the determination for permanent coverage. In November 2021, days before MCIT was set to take effect, the Biden Administration repealed the rule, citing “operational challenges.” Nearly three years later in August 2024, the Biden Administration released a replacement rule with additional barriers and burdens. The Ensuring Patient Access to Critical Breakthrough Products Act provides a clear pathway for four years of transitional Medicare coverage of breakthrough devices upon the manufacturer’s application and requires CMS to make a permanent coverage determination by the end of the temporary period. This expedited coverage pathway will encourage more innovative medical devices to come to market and provide quicker access to treatments for Medicare patients.