Press Releases

Today, the House Ways & Means Committee marked up the Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691), bipartisan legislation introduced by Representatives Suzan DelBene (WA-01) and Brad Wenstrup (OH-02) to provide Medicare beneficiaries with faster access to safe, effective breakthrough medical devices. The bill was approved 36-5.

The bill would address the multi-year delay seniors face in accessing novel medical products by enabling eligible ‘breakthrough’ devices to get four years of temporary Medicare coverage following Food and Drug Administration (FDA) approval. During that temporary coverage period, the manufacturer and the Centers for Medicare & Medicaid Services (CMS) would work together to achieve a permanent coverage determination.

Currently, new medical devices that provide more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions that have no approved alternatives or offer significant advantages over existing options can receive breakthrough designation by the FDA. However, breakthrough devices are not always covered by Medicare, even after they are approved. Achieving some form of Medicare coverage for these devices takes an average of over 5 years after FDA approval, according to the Stanford Byers Center for Biodesign, delaying seniors’ access to potentially life-changing new diagnostic and treatment options.

“Seniors shouldn’t have to wait years for safe and effective treatments that could save their lives,” said DelBene. “Our legislation advanced by the House Ways & Means Committee with a strong bipartisan vote today is a great step toward driving innovation and investment in state-of-the-art technologies while removing barriers that hinder access to care. By ensuring Medicare covers breakthrough medical devices, we are improving the quality of life for millions of seniors and providing them with new hope.”

The bill now awaits a vote on the House floor. The text of the legislation can be found here.