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DelBene Reintroduces Critical Bipartisan Legislation Ensuring Patient Access to Breakthrough Medical Products

Today, Congresswoman Suzan DelBene (WA-01) reintroduced the Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333). 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. DelBene’s 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). 

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. DelBene’s 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.  

For a medical product to earn the FDA’s “breakthrough” designation it must meet the following criteria: 

  • provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions;  
  • has no approved alternatives;  
  • offers significant advantages over existing approved alternatives; or 
  • availability is in the best interest of patients. 

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, 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. For example, software or digital products, such as Prescription Digital Therapeutics are not eligible for Medicare coverage because today there is no appropriate benefit category. DelBene’s bill 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. 

“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 Rep. 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.” 

“We need to remove the unnecessary barriers preventing seniors from getting the cutting-edge medical products they need, including medical devices,” Congresswoman Walorski said. “The Ensuring Patient Access to Critical Breakthrough Products Act will encourage life-saving medical innovation and expand treatment options covered by Medicare. These important reforms will open new doors for future innovative therapies and cures that will improve quality of life for seniors.” 

“It’s wrong that our seniors are forced to wait years for access to critical medical technologies,” said Congressman Cárdenas. “This bill cuts the time Medicare enrollees must wait to access revolutionary medical technology by improving the determination process for patients. This is a smart, bipartisan solution to a problem that affects millions of seniors across the United States.”

“This legislation will help millions of seniors on Medicare by ensuring more timely access to the treatments they need,” said Congressman 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.”

“All Americans deserve access to life-saving, breakthrough therapies and devices,” said Rep. Terri Sewell. “This bill takes a critical step in the right direction to ensure that the review and approval process for breakthrough therapies doesn’t inhibit patient access to innovative and effective technologies as they come to market.”

“It is critical that Medicare beneficiaries receive timely access to innovative therapies that bring positive health outcomes,” said Congressman Marshall. “This bipartisan bill encourages the development of new medical devices to treat life-threatening illnesses by bridging the coverage gap so our seniors can actually access them. This is a common-sense initiative and I’m pleased to join this bipartisan group in working to bring innovative treatments and cures to America’s seniors.”

DelBene previously introduced the Ensuring Patient Access to Critical Breakthrough Products Act in 2018 during the 115th Congress.