Ensuring Patient Access to Critical Breakthrough Products Act of 2025 amends Medicare to expedite coverage for breakthrough medical devices.

The Ensuring Patient Access to Critical Breakthrough Products Act of 2025 amends title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program. The bill requires the Secretary of Health and Human Services to make a determination on a device application within six months and designate a device as a breakthrough device if it meets specified criteria. It also mandates that a final decision on a national coverage determination request for a breakthrough device be made before the end of the transitional coverage period.

Ensuring Patient Access to Critical Breakthrough Products Act of 2025 amends Medicare to expedite coverage for breakthrough medical devices.

The Ensuring Patient Access to Critical Breakthrough Products Act of 2025 amends title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program. The bill requires the Secretary of Health and Human Services to make a determination on a device application within six months and designate a device as a breakthrough device if it meets specified criteria. It also mandates that a final decision on a national coverage determination request for a breakthrough device be made before the end of the transitional coverage period.