U.S. Rep. Suzan DelBene (D-Wash) reintroduced a bill today to improve Medicare patient access to breakthrough medical devices.
The Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333) would require Medicare to temporarily cover all devices approved through the FDA’s breakthrough pathway for three years, during which the Centers for Medicare and Medicaid Services (CMS) must make a permanent coverage determination.
The bill would also provide temporary coverage for certain breakthrough devices that did not exist or were not contemplated when Medicare was first created and do not have a Medicare benefit category. Since last Congress, the FDA has granted breakthrough status to products that do not have a benefit category in Medicare, and therefore no pathway or coverage for Medicare patients.
“Guaranteeing coverage of breakthrough technologies and opening the door to coverage of new digital-based products encourages investment in the industry, facilitating innovation and future advancements,” DelBene said in a news release.
The bill is co-sponsored by Rep. Jackie Walorski (R-IN), Rep. Tony Cárdenas (D-CA), Rep. Gus Bilirakis (R-FL), Rep. Terri Sewell (D-AL), and Rep. Roger Marshall (R-KS). It was originally introduced in June 2018.
Medtech trade group AdvaMed praised DelBene and her co-sponsors for reintroducing the bill.
“CMS has made great strides in recent months to ensure Medicare beneficiaries have access to the most innovative medical care, and this important legislation would build on these critical reforms,” said AdvaMed president & CEO Scott Whitaker in a separate news release. “We thank Reps. DelBene, Walorski, Cardenas, Bilirakis, Marshall and Sewell for their leadership and their commitment to ensuring patients and physicians benefit from breakthrough medical technologies in a timely manner. We look forward to working with Congress, CMS, and other key stakeholders to move the bill forward.”
