Press Releases

DelBene ‘Breakthrough’ Legislation Included in CURES 2.0 Package

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Washington, D.C., November 16, 2021 | comments

Congresswoman Suzan DelBene (WA-01) welcomed the inclusion of legislation that she introduced to expand patients’ access to breakthrough medical devices in the bipartisan CURES 2.0 Act introduced by Representatives Diana DeGette (CO-01) and Fred Upton (MI-06) today.

The Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 4043), which DelBene introduced with Representatives Jackie Walorski (IN-02), Tony Cárdenas (CA-29), Gus Bilirakis (FL-12), Terri Sewell (AL-07), and Upton, would guarantee Medicare beneficiaries access to cutting-edge medical innovation.

“I worked hard to make sure that the CURES 2.0 package included critical reforms I championed to ensure patients can access cutting-edge medical technology and care,” said DelBene. “By guaranteeing coverage of breakthrough products, the CURES 2.0 Act is welcoming the way for future innovation and making sure our seniors are not waiting on new cures and therapies that could improve or save their lives.”

Currently, Medicare does not automatically cover the latest advances in medical technology, even when the products are approved or cleared by the Food and Drug Administration (FDA) and designated as a breakthrough product. FDA-approved products can take up to three years to go through the Medicare coverage determination process, delaying vital treatments to millions of seniors.

The legislation would require Medicare to temporarily cover all breakthrough products approved through the FDA for four years. During this period, the Centers for Medicare and Medicaid Services (CMS) would be required to make a permanent coverage determination. This allows patients and their providers access to the most cutting-edge, innovative care as soon as it comes to market. 

In January, CMS finalized the Medicare Coverage for Innovative Technology (MCIT) rule, which like the Ensuring Patient Access to Critical Breakthrough Products Act would provide temporary Medicare coverage for products that have received breakthrough designation by the FDA and help Medicare beneficiaries access these new technologies. However, the CMS has since rescinded the rule but has pledged to redo it.

The text of the CURES 2.0 Act can be read here. More information about the Ensuring Patient Access to Critical Breakthrough Products Act can be found here

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