Bill to Provide Cutting Edge Medicine

Representative Suzan DelBene (D-WA) on June 5, 2018 introduced the “Ensuring Patient Access to Critical Breakthrough Products Act of 2018” (H.R 5997) to guarantee Medicare beneficiaries access to cutting edge medical innovations.

The bipartisan legislation is cosponsored by Representatives Terri Sewell (D-AL) , Jackie Walorski (R-IN), Gus Bilirakis (R-FL), and Tony Cardenas (D-CA)

Currently, Medicare does not automatically cover the latest advances in medical technology even for medical devices that are approved through FDA’s 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 Product Act” would require Medicare to cover all breakthrough products that are approved through the FDA’s expedited review process for three years. Within the three years, Medicare must make a permanent coverage determination.

For a medical device to earn the breakthrough designation, the technology must:

  • Provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions
  • Have no approved alternatives
  • Offer advantages over existing approved alternatives
  • Provide availability to the innovation


As Representative DelBene notes, “The senior population shouldn’t have to wait to access medical products that can change or even save their lives. The guaranteed coverage of these breakthrough technologies will also foster investment in the industry which will yield greater advances in the future.”

“This bill will streamline Medicare coverage for approved technologies that go through the FDA’s medical device review process. This bill would also promote a more efficient regulatory ecosystem so that the roughly 1,700 medical device companies located in California could continue to develop and innovate and spend more time taking care of customers in need”, said Representative Cardenas.

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