Yakym, Colleagues Advance Bipartisan Bill to Improve Patient Healthcare

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

"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."

"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"Too often, outdated policies stand between patients and the treatments they need," Rep.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."

"This legislation will help millions of seniors on Medicare by ensuring more timely access to the treatments they need," Rep. 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."

"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."

Watch Rep. Yakym speak in support of this bill during today's markup HERE.

"Patients shouldn't have to wait years to benefit from medtech the FDA has already determined to be safe and effective for patients," Scott Whitaker, President & CEO, AdvaMed, the Medtech Association said. "This legislation ensures that delays in coverage and reimbursement decisions through Medicare no longer stand between patients and life-changing innovations. We thank the committee for its leadership, and urge Congress to pass this bipartisan legislation so patients can access the most advanced medical technologies available to help alleviate their suffering."

"On behalf of the Zimmer Biomet team members, our healthcare partners, and the patients we serve, we offer our support for H.R. 5343, the "Ensuring Patient Access to Critical Breakthrough Products Act," Heather Falen Ashby, VP, Government Affairs for Zimmer Biomet said. "Zimmer Biomet has a bold strategy to bring innovative products to market that improve, drive efficiencies, and result in better patient outcomes. This bill helps Zimmer Biomet, and the MedTech industry at large, deliver on those goals by alleviating the uncertainty and unpredictability associated with Medicare's coverage of novel medical technologies. We thank Congressman Yakym and the Ways and Means Committee for this taking a step towards increasing patient access to breakthrough technologies by advancing this legislation."

Background:

This bill ensures Medicare coverage for medical devices approved through the FDA's Breakthrough Devices Program, which fast-tracks treatments and diagnostics for life-threatening or debilitating conditions. It provides temporary coverage for these devices under Medicare for four years, requires CMS to assign payment codes within three months of FDA approval, and directs CMS to create a pathway for continued coverage after the transitional period.

You can find bill text here and on Congress.gov.

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