Press Releases

Today, Representatives Suzan DelBene (WA-01), Jackie Walorski (IN-02), Terri Sewell (AL-07), Gus Bilirakis (FL-12), and Roger Marshall (KS-01) released the following statement after the Centers for Medicare & Medicaid Services’ (CMS) announced a proposed rule to streamline Medicare coverage for cutting-edge medical innovations.

“We are pleased to see CMS’s proposal to help increase Medicare beneficiaries’ access to cutting-edge, innovative medical breakthroughs. These proposed changes reflect the substance of the Ensuring Patient Access to Critical Breakthrough Products Act and will end the hurry-up-and-wait approach to providing access to new cures and therapies. These long-overdue changes will allow Medicare’s coverage policy to keep up with the current pace and wide variety of treatments being brought to market by streamlining coverage of FDA-designated breakthrough products. This will also encourage more investments in the cures of tomorrow.”

The Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5333) was introduced by Reps. DelBene, Walorski, Sewell, Bilirakis, and Marshall and would guarantee Medicare beneficiaries access to cutting-edge medical innovation by streamlining the coverage determination process and improving the availability of breakthrough devices for patients. Specifically, H.R. 5333 would temporarily guarantee Medicare coverage of products approved by the FDA with a breakthrough designation. During that temporary coverage period, CMS would be required to make a permanent coverage decision.

More information about the proposed rule can be found here.