Bipartisan Bill Could Improve Breakthrough Device Availability for Medicare Patients

New bipartisan legislation is looking to improve the availability of breakthrough devices for Medicare beneficiaries. The Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333) was reintroduced by U.S. Rep. Suzan DelBene (D-Wash). She previously introduced the bill in 2018. The bipartisan legislation is being co-led 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). Right now, Medicare does not automatically cover the latest advances in medical technology, even when the products are approved through FDA’s breakthrough pathway process. Medicare’s coverage determination for FDA approved products can take up to three years, delaying vital treatments to millions of seniors. The Ensuring Patient Access to Critical Breakthrough Products Act would require Medicare to temporarily cover all breakthrough products approved through FDA’s breakthrough pathway for three-years, during which the Centers for Medicare and Medicaid Services (CMS) must make a permanent coverage determination. H.R. 5333 also provides 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, FDA has granted breakthrough status to products that do not have a benefit category in Medicare, and there...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news