Ensuring Patient Access to Critical Breakthrough Products Act

This bill would let Medicare temporarily cover certain medical devices that went through a special FDA program designed to speed up the review of devices used to treat or diagnose life-threatening or serious conditions. To qualify, manufacturers would need to apply to the Centers for Medicare & Medicaid Services, and the devices would need to meet several requirements, including having gone through priority FDA review and not posing risks that outweigh their potential benefits. If approved, the devices would be covered under Medicare for a four-year period, during which a decision about permanent coverage must be made. The bill also gives the Centers for Medicare & Medicaid Services funding through 2030 to carry out these requirements.

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