FDA breakthrough devices lose special Medicare payment pathways after October rule change
FDA-designated breakthrough devices will no longer qualify for extra Medicare payments once the new rule takes effect in October.
In recent weeks the FDA assigned breakthrough status to several medical technologies, such as algorithms that prioritize abdominal CT scans, panels for diagnosing urinary-tract infections, and robotic systems for clot removal. These designations have been tracked by a journalist at one outlet, which lists nearly 800 entries since 2022. Meanwhile, the Centers for Medicare and Medicaid Services completed a rule change that ends the streamlined pathways allowing breakthrough devices to obtain new-technology add-on and transitional pass-through payments.
Previously, since 2020, devices with the designation could receive these supplemental Medicare funds without demonstrating a substantial clinical advantage or novelty. Effective October, the new policy will prevent all breakthrough-designated devices from qualifying for those extra payments.
Why it matters
The policy shift removes a financial shortcut for innovative devices, influencing their rollout and patient access.
In this story
