Ensuring Patient Access to Critical Breakthrough Products Act of 2024

This bill, the Ensuring Patient Access to Critical Breakthrough Products Act of 2024, creates a 4-year period during which Medicare must cover innovative medical devices designated as "breakthrough" by the FDA, unless they are not used as labeled or pose an undue risk. It requires the FDA to make breakthrough device designation decisions within 6 months and mandates that Medicare issue final coverage decisions before the 4-year period ends. The bill also appropriates $10 million annually from 2025 to 2030 to fund these new Medicare coverage processes. This primarily affects Medicare beneficiaries, FDA, and the Centers for Medicare & Medicaid Services.