Monique Nolan, M.D., J.D. ([email protected])

U.S. Health and Human Services Tries Again To Improve Availability of Innovative Devices in Medicare

On April 23, 2026, the Centers for Medicare & Medicaid Services and the U.S. Food and Drug Administration (FDA) announced a plan to create a new pathway to expedite Medicare coverage for certain medical devices designated by the FDA as breakthrough devices (the Announcement). Devices travelling the new Regulatory Alignment for Predictable and Immediate Devic