HR 4043

This bill, the Ensuring Patient Access to Critical Breakthrough Products Act of 2021, aims to improve Medicare coverage for innovative medical devices, known as ‘breakthrough devices.’ It establishes a temporary period where these devices are covered under Medicare, allowing the Centers for Medicare & Medicaid Services (CMS) to determine appropriate payment rates and establish a process for continued coverage. The bill also mandates CMS to assign payment codes for breakthrough devices within three months of FDA approval and to develop a plan for long-term coverage, considering additional data and evidence. Finally, it establishes a process for identifying and collecting necessary data to support Medicare coverage decisions.