Press Releases

Today, Representatives Suzan DelBene (WA-01) and Brad Wenstrup (OH-02), along with Bilirakis (FL-12), Cárdenas (CA-29), Moore (UT-01), Sewell (AL-07), Guthrie (KY-02), and Eshoo (CA-16), introduced the Ensuring Patient Access to Critical Breakthrough Products Act, legislation that would provide Medicare beneficiaries with faster access to safe, effective breakthrough medical devices.

Currently, new medical devices that provide more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions, have no approved alternatives, or offer significant advantages over existing options can receive breakthrough designation by the Food and Drug Administration (FDA). Unfortunately, breakthrough devices are not always covered by Medicare, even after they are approved. The Medicare coverage determination process can take up to three years, delaying seniors’ access to potentially life-changing new diagnostic and treatment options.

For example, ReCor Medical recently developed a novel treatment for high blood pressure, a condition that three out of every four seniors in the United States have. Hypertension is estimated to cost our health care system $50 billion a year. This treatment has been shown to decrease blood pressure in two out of every three patients in clinical trials and was given breakthrough designation. If this treatment was covered by Medicare faster, it could help seniors live longer lives and experience fewer cardiovascular issues.

The legislation would ensure that FDA-designated breakthrough products are covered by Medicare for four years. During this period, the Centers for Medicare & Medicaid Services (CMS) would be required to make a permanent coverage determination. This will ensure that seniors have access to the most innovative care as soon as it is deemed safe and effective. 

The bill also provides temporary coverage for certain breakthrough devices that did not exist or were not considered when Medicare was first created, like digital therapeutics.

“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.”

“Seniors should be able to access the most innovative care and breakthrough devices as soon as we know these are deemed safe and effective by the FDA. They should not have to wait years for a Medicare coverage decision on life-saving treatments,” said Wenstrup. “With this legislation, millions of seniors could live longer, healthier lives, and companies that develop these innovative treatments would be supported in their investment in medical technologies and devices.”

“In order for companies to invest in new medical technologies they need a clear path to both FDA-approval and reimbursement. Increasingly, the time and uncertainty associated with securing reimbursement has become the major barrier for young companies looking to invest in groundbreaking medical technologies,” said Marc Cummings, President & CEO of Life Science Washington. “The Ensuring Patient Access to Critical Breakthrough Products Act provides the certainty that companies need to invest in new technologies to diagnose and treat diseases that don’t have effective therapies today, while also ensuring that doctors and patients are able to utilize game-changing medical technologies as soon as they are approved.”

The text of the legislation can be found here.