Ensuring Patient Access to Critical Breakthrough Products

This bipartisan legislation would enable millions of patients to receive quicker access to life- changing medical innovations. The legislation is designed to expedite the Medicare coverage determination process of breakthrough medical technologies for patients.

Although the House of Representatives generated some momentum on related legislation, H.R. 1691, a Senate companion bill, S. 5349, the “Ensuring Patient Access to Critical Breakthrough Products Act”, was introduced in late November 2024 for potential passage in the lame duck session.

S. 5349 would grant four years of national coverage to any FDA-authorized Breakthrough Device after CMS affirms its status and requires the Medicare agency to consider a permanent national coverage policy during that period.

MichBio, and its partners, AdvaMed and MDMA, as well as other medical device industry advocates pushed Congress to pass the “Ensuring Patient Access to Critical Breakthrough Products Act” this year as part of an end-of-year federal spending bill. Alas, it was not meant to be, as this bill, like many others, died an inglorious death. The legislation will be a high priority for 2025.