Ensuring Patient Access to Critical Breakthrough Products Act

This bill, titled the "Ensuring Patient Access to Critical Breakthrough Products Act," aims to streamline Medicare coverage for innovative medical technologies. It establishes a new 4-year transitional coverage period for devices designated as "breakthrough" by the Secretary of Health and Human Services, ensuring beneficiaries can access these products more quickly. During this period, Medicare will cover these devices unless they are used outside their Food and Drug Administration (FDA)-approved labeling or are found to pose an undue risk of harm. To qualify for this transitional coverage, a device must meet specific criteria, including having received priority review from the FDA. The Secretary must also determine that the device would otherwise be covered under Medicare Parts A or B and does not present an undue risk of harm that outweighs its potential clinical benefits. The bill mandates a clear process for manufacturers to apply for this designation, requiring a determination within six months and an explanation if the designation is denied. Furthermore, the legislation requires the Secretary to make a final National Coverage Determination (NCD) for a breakthrough device before the end of its 4-year transitional coverage period. This ensures a permanent coverage decision is in place following the temporary period, provided the NCD request was submitted sufficiently in advance. The bill also appropriates $10 million annually from fiscal years 2025 through 2030 to the Centers for Medicare & Medicaid Services to implement these new provisions.