Medicare to End Extra Payments for FDA Breakthrough Devices Starting FY2028

Medicare announced that it will eliminate the special pathways that have let medical devices labeled as breakthrough by the FDA receive supplemental payments without showing a clear clinical advantage.

The Centers for Medicare & Medicaid Services said the rule will apply to both inpatient and outpatient hospital payments and will take effect in fiscal year 2028.

Under the new policy, manufacturers will have to prove that their breakthrough devices provide substantial clinical improvement over existing alternatives to qualify for the extra payments that were intended to support early adoption of costly, transformative technology.