DelBene Leads Bipartisan Push to Increase Seniors’ Access to Breakthrough Medical Devices

Today, Representatives Suzan DelBene (WA-01), Blake Moore (UT-01), Rudy Yakym (IN-02), Terri Sewell (AL-07), Lori Trahan (MA-03), and Gus Bilirakis (FL-12) led a bipartisan letter urging Department of Health and Human Services Secretary Kennedy and Administrator for the Centers for Medicare & Medicaid Services Oz to take action on improving Medicare coverage for FDA-designated breakthrough medical devices.

The Breakthrough Devices Program is an accelerated FDA review process that gives patients access to innovative technologies, while ensuring they are safe and effective. Several groundbreaking technologies have benefited from this program, including blood tests, cancer therapies, and bone grafts. However, there is often a multi-year delay for Medicare to cover these devices even after FDA approval. This negatively impacts seniors' access to innovative technologies and harms overall health outcomes.

"Seniors should not be forced to wait years for cutting-edge, safe, and effective treatments that could change or even save their lives," said DelBene. "Guaranteeing Medicare coverage of breakthrough medical devices would encourage future innovation and investment in next-generation medical technologies while improving the quality of life for millions of seniors. We can't let the coverage approval process be a barrier to life-saving treatments or care."

"When the FDA designates a device as a breakthrough technology, that means that there is nothing similar already available to patients having the potential to change or save lives," said Yakym. "Seniors on Medicare shouldn't have to wait years to access it simply because of bureaucratic processes. This letter makes clear that Congress expects action, and I will keep pushing until patients in Indiana and across the country can get the care they need without unnecessary delays."

"There is no reason that Medicare patients should have to wait to access breakthrough medical devices already cleared by the FDA. The Ensuring Patient Access to Critical Breakthrough Products Act ensures patients receive the most advanced treatments on the market as soon as possible," said Moore. "Easing the pathway for Medicare approval has long been a bipartisan priority, and I look forward to working with Secretary Kennedy to ensure this crosses the finish line for our seniors."

"All Americans deserve access to life-saving, breakthrough therapies and devices," said Sewell. "This letter takes a critical step in the right direction to ensure that the review and approval process for breakthrough therapies does not inhibit patient access to innovative and effective technologies for our seniors."

"When the FDA designates a device as a breakthrough, it means it has the potential to change or even save a patient's life," said Trahan. "Medicare seniors shouldn't have to wait years to access treatments that have already cleared that bar. This bipartisan effort is about making sure our coverage policies keep pace with medical innovation, so patients here in Massachusetts and across the country can get the care they need without unnecessary delays."

This effort has earned broad support from industry leaders and patient advocacy organizations across the healthcare community, including MDMA, AdvaMed, Alzheimer's Association, Roche Diagnostics, National Health Council, HealthyWomen, Alzheimer's Impact Movement, Siemens Healthineers, and Indiana Life Sciences Association.

The letter was signed by 82 Members of Congress and received support from leading health and industry organizations.