CLSA Applauds Re-Introduction of Legislation to Increase Patient Access to Medical Technologies

June 17,  2018
Adam Lotspike

CLSA is proud to endorse the Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5997). This bipartisan legislation, re-introduced on June 6 by Representatives Tony Cárdenas (D-San Fernando Valley), Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Gus Bilirakis (R-Fla.) and Terri Sewell (D-Ala.), bridges Medicare patient access gaps and modernizes policies to allow coverage of medical technologies approved through FDA’s expedited review process.

CLSA strongly supports H.R. 5997, which would provide immediate temporary Medicare coverage and payment for technologies cleared under the FDA’s Breakthrough Device pathway. Specifically, the bill improves timely patient access to innovative breakthrough technologies by revising existing law to allow qualifying FDA-approved breakthrough medical device technologies to be automatically eligible for New Technology Add-On Payment (NTAP) and outpatient pass-through status for three years.

The 21st Century Cures Act, signed into law in 2016, created a “Breakthrough Pathway” designation for medical devices at FDA, establishing criteria under which certain medical devices would be eligible for expedited review. Specifically, the program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives. CLSA was strongly and actively supportive of that proposal.  H.R. 5997 takes the next step in ensuring that efficient regulatory processes at FDA are coupled with timely and appropriate coverage and payment determinations at CMS, thereby promoting continued medical device research and development and, most important, assuring swift patient access to these life-saving and life-sustaining treatments.

Working in collaboration with our member companies and our national trade association partner, AdvaMed, CLSA supported the reintroduction of the legislation and applauds the efforts of California Representative Tony Cárdenas (D-San Fernando Valley), a member of the powerful House Energy & Commerce Committee, in leading efforts to move this bill through the legislative process. CLSA is working to secure additional cosponsors of the bill, and advocating for swift action on this legislation this year. A copy of our letter of endorsement of H.R. 5997 is available here, and a 2-page backgrounder in support of the bill is available here. Additionally, a State Medical Technology Alliance (SMTA) letter of endorsement, co-signed by 36+ state and regional life sciences associations across the country, is available here.

Click here to view CLSA’s press release applauding H.R. 5997.

For questions, please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations and Alliance Development (