Bill > S5349

This bill aims to ensure prompt coverage of breakthrough devices under the Medicare program. It amends the Social Security Act to provide a "transitional coverage period" of 4 years for breakthrough devices designated by the Secretary, during which Medicare will cover the use of these devices even if they are not used in accordance with the approved labeling or present an undue risk of harm. The bill also requires the Secretary to make a determination on breakthrough device designation within 6 months of a manufacturer's application and to ensure a final decision on national coverage for a breakthrough device is made before the end of the transitional coverage period. Additionally, the bill appropriates $10 million annually from 2025 to 2030 to the Centers for Medicare & Medicaid Services to implement these changes.