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WASHINGTON, D.C. – Congressman Brett Guthrie (KY-02), who serves as the Chair of the Energy and Commerce Committee Subcommittee on Health, helped introduce the Ensuring Patient Access to Critical Breakthrough Products Act.

“Breakthrough medical devices can give patients a better quality of life and even save lives. That’s why it’s important to ensure seniors can more quickly access FDA-approved breakthrough medical devices, which by definition are able to provide more effective treatment options for debilitating or life-threatening conditions. Ensuring Patient Access to Critical Breakthrough Products Act would achieve this goal by streamlining Medicare coverage of breakthrough medical devices. I’m proud to support this bipartisan bill and urge my colleagues to support it,” said Guthrie.

The Ensuring Patient Access to Critical Breakthrough Products Act of 2023 requires Medicare to temporarily cover all medical devices approved under the Food and Drug Administration (FDA) Breakthrough Devices Program for four years. To meet the criteria of the Breakthrough Device Designation, a device must deliver more effective treatment or diagnosis for patients facing life-threatening or irreversibly debilitating disease or conditions. In addition, the device must also at least be a breakthrough technology; provide significant advantages over approved, existing alternatives; be in the best interest of patients; or fill a gap where no approved alternatives exist. During the four-year temporary coverage of a breakthrough device, the Centers for Medicare and Medicaid Services (CMS) would be required to determine if the device should receive permanent coverage under Medicare.

Representatives Suzan DelBene (WA-01) and Brad Wenstrup (OH-02) introduced the Ensuring Patient Access to Critical Breakthrough Products Act along with Representatives Guthrie, Gus Bilirakis (FL-12), Tony Cárdenas (CA-29), Blake Moore (UT-01), Terri Sewell (AL-07), and Anna Eshoo (CA-16).

In 2021, Guthrie led a bipartisan letter to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure to express disappointment with CMS’s decision to repeal the Trump-era Medicare Coverage for Innovative Technology (MCIT) rule, which would have streamlined the Medicare coverage pathway for breakthrough products to help Medicare beneficiaries access these products faster. The Members encouraged CMS to keep components of the MCIT rule. Click HERE to read the letter.

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