Walorski Introduces Bipartisan Legislation Ensuring Patient Access to Critical Breakthrough Products

Tuesday, June 5, 2018

Walorski Introduces Bipartisan Legislation Ensuring Patient Access to Critical Breakthrough Products

WASHINGTON – U.S. Rep. Jackie Walorski (R-Ind.) today joined Rep. Suzan DelBene (D-Wash.) in introducing the Ensuring Patient Access to Critical Breakthrough Products Act of 2018 (H.R. 5997), a bill that would guarantee Medicare beneficiaries access to cutting edge medical innovation. The bipartisan legislation is cosponsored by Rep. Terri Sewell (D-Ala.), Rep. Gus Bilirakis (R-Fla.), and Rep. Tony Cardenas (D-Calif.).

Currently, Medicare does not automatically cover the latest advances in medical technology. This is true even for medical devices that are approved through the Food and Drug Administration’s (FDA) expedited review process. The lag between FDA’s approval and Medicare’s coverage determination can take up to three years. The Ensuring Patient Access to Critical Breakthrough Products Act would require Medicare to cover all breakthrough products that are approved through the FDA’s expedited review process for three years. Within those three years Medicare must make a permanent coverage determination. For a medical device to earn the “breakthrough” designation the new technology must meet the following criteria:

  • provides 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.

“The best way to encourage life-saving medical innovation is to remove unnecessary barriers to patients getting the cutting-edge medical products they need,” Rep. Walorski said. “By allowing Medicare patients to access breakthrough technologies faster, the Patient Access to Critical Breakthroughs Act will expand treatment options for patients and open new doors for future innovative therapies and cures.”

“It makes no sense that Medicare drags it feet to cover cutting edge technologies especially when the FDA works to expedite their own review process for these same treatments. Seniors shouldn’t have to wait to access medical products that can change or even save their lives,” Rep. DelBene said. “The guaranteed coverage of these breakthrough technologies will also foster investment in the industry and which will yield greater advances in the future.”

“America’s medical device manufacturers and innovators are working every day to develop cutting-edge life-saving therapies and devices,” said Rep. Terri A. Sewell. “We must ensure that the review and approval process for breakthrough therapies doesn’t inhibit patient access to the most innovative and effective technologies coming to market. The introduction of the Ensuring Patient Access to Critical Breakthrough Products Act of 2018 is a step towards streamlining the regulatory process and ensuring that these devices reach the patients who need them in a timely manner.”

“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.”

“I am proud to co-sponsor this bill, as it would streamline Medicare coverage for approved technologies that go through the FDA’s medical device review process. This would provide patients with timely access to life-saving innovations. It would also promote a more efficient regulatory ecosystem so that the roughly 1,700 medical device companies in California could continue to develop and innovate and spend more time taking care of customers in need,” said Rep. Cardenas.

Walorski represents the 2nd Congressional District of Indiana, serving as a member of the House Ways and Means Committee.

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