Bill > HR5343

This bill aims to improve Medicare coverage for innovative medical devices known as "breakthrough devices" by creating a new process for their rapid approval and coverage. Under the bill, the Secretary of Health and Human Services would be required to designate certain medical devices as breakthrough devices if they meet specific criteria, such as receiving priority review from the FDA and showing potential clinical benefits. Once designated, these devices would receive a four-year "transitional coverage period" during which Medicare would provide coverage, even if the device does not perfectly match traditional coverage requirements. The bill mandates that the Secretary review breakthrough device applications within 6 months, provide explanations for any denials, and submit annual reports to Congress about the number of applications received and devices designated. Additionally, the bill appropriates $10 million per year from fiscal years 2025 to 2030 to support the implementation of this new process. The goal is to ensure that Medicare patients can more quickly access cutting-edge medical technologies that have the potential to improve health outcomes.

Budget and Finance

https://www.congress.gov/bill/119th-congress/house-bill/5343/all-info