Congressman Blake Moore's Bipartisan Legislation to Increase Access to Breakthrough Medical Devices Passes Committee

Congressman Blake Moore's Bipartisan Legislation to Increase Access to Breakthrough Medical Devices Passes Committee

WASHINGTON - Representatives Blake Moore (R-UT), Suzan DelBene (D-WA), Rudy Yakym (R-IN), Terri Sewell (D-AL), Gus Bilirakis (R-FL), and Lori Trahan (D-MA) 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.

"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."

"New and innovative medical treatments are of no good to patients who cannot gain access to them," said Ways and Means Committee Chairman Jason Smith (R-MO). "Delays in the government approval process are an unacceptable threat to the health of America's seniors. With the Ensuring Patient Access to Critical Breakthrough Products Act, Representative Moore is leading the charge to break down barriers to life-saving treatments and fuel the innovative spirit in America's health care system that will also lead to long-term cost savings for America's seniors and taxpayers."

"Too often, outdated policies stand between patients and the treatments they need," Rep.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

"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."

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.

Supporting organizations: AdvaMed, Biocom California, BioUtah, California Life Sciences Association, MassMEDIC, Medical Device Manufacturers Association, Novocure, AMAC Action, and Research America.

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

Rep. Moore's comments during the markup can be found below.

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