U.S. Rep. Gus Bilirakis, R-Fla., is behind a bipartisan push on Capitol Hill to bring more medical technology in treating Americans on Medicare.
Bilirakis is backing U.S. Rep. Suzan DelBene’s, D-Wash., “Ensuring Patient Access to Critical Breakthrough Products Act.”
“This bill 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. Currently, Medicare does not automatically cover the latest advances in medical technology, even when the products are approved through the Food and Drug Administration’s (FDA) 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 the FDA’s breakthrough pathway for a three-year period, during which the Centers for Medicare and Medicaid Services (CMS) must make a permanent coverage determination. This allows patients to receive the most cutting-edge, innovative care as soon as it comes to market,” the congressman’s office noted on Monday.
“This legislation will help millions of seniors on Medicare by ensuring more timely access to the treatments they need,” said Bilirakis. “Additionally, there are more than 600 medical device companies in our state working to develop innovative and effective products. During a roundtable discussion in my district, I heard from many of these businesses about how these lengthy and unnecessary Medicare coverage delays create a significant barrier in bringing new products to market. This bill is about connecting patients with important devices and technologies more quickly. Additionally, it is about encouraging innovation rather than stifling it. Government has to get out of the way and streamline the payment process for effective new devices that can ultimately help improve and save lives.”
The bill “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” and would “allow the Health and Human Services (HHS) Secretary the flexibility to make coverage determinations for products that have FDA breakthrough status but no benefit category.”
DelBene also weighed in on the bill on Monday.
“This hurry-up-and-wait situation makes no sense. Seniors shouldn’t have to wait unnecessarily to access medical products that can change or even save their lives,” said DelBene. “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 also reeled in four other cosponors from both sides of the aisle. The bill was sent to the U.S. House Ways and Means and the Energy and Commerce Committees. So far, there is no companion bill over in the U.S. Senate.
Reach Kevin Derby at [email protected].
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