Medicare Breakthrough Medtech Coverage Advances with Congressional Backing

The U.S. House Energy and Commerce Health Subcommittee recently highlighted the necessity for Medicare coverage of FDA-authorized breakthrough medical technologies through a hearing and the introduction of the Ensuring Patient Access to Critical Breakthrough Products Act of 2025.

This legislation aims to streamline access for Medicare beneficiaries to innovative medical devices that have received the FDA's breakthrough designation, indicative of their safety and effectiveness. AdvaMed, a leading medtech association, has lauded the subcommittee's efforts and called for the inclusion of diagnostic tests in the legislation to ensure comprehensive coverage of breakthrough health technologies.

The discussion draft and related legislative actions underscore a bipartisan congressional focus on reducing delays in Medicare coverage for cutting-edge medical devices. Additionally, leadership from the FDA and Centers for Medicare & Medicaid Services (CMS) are collaborating on strategies to accelerate Medicare approval processes and avoid redundant regulatory hurdles.

The legislative momentum comes alongside broader governmental initiatives, including the CMS’s $50 billion Rural Health Transformation Program, aimed at enhancing healthcare access through advanced technologies in underserved areas. Industry stakeholders, including prominent medtech leaders, credit these policy developments with potentially transformative impacts on patient care and market dynamics within the U.S. healthcare system.