ARTICLE SUMMARY:
Breakthrough Device Medicare coverage is introduced in the Senate. Excerpted from Pathways’ Picks November 20: RFK Jr., Dr. Oz, UK Reforms, Generative AI, and More.
Legislation to establish a new streamlined pathway to Medicare coverage for FDA Breakthrough Devices was introduced in the Senate November 20. Device industry advocates are pushing Congress to pass the “Ensuring Patient Access to Critical Breakthrough Products Act” this year before the new, post-election sessions begins in January as part of an end-of-year federal spending bill. The bill 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. In June, the House Ways and Means Committee approved its version of the bill, which includes more details to ensure the covered devices also receive payment and coding from Medicare and to include Breakthrough Devices that are included in a current benefit category.