STAT+: Medicare eliminates key pathways used by ‘breakthrough’ devices for extra payments

Medicare is eliminating key pathways that have enabled "breakthrough" medical devices, as designated by the Food and Drug Administration, to receive additional payments. Previously, authorized breakthrough devices could qualify for supplemental payments without demonstrating their novelty or substantial clinical improvement over alternatives.

The Centers for Medicare and Medicaid Services has finalized a proposal to repeal these pathways for both inpatient and outpatient settings, effective from the fiscal year 2028. These payments were designed to encourage hospitals to adopt new, transformative technology while it is still expensive, and to provide makers with time to prove the devices' value.

Requiring breakthrough devices to show substantial clinical improvement, the rule aims to ensure that additional Medicare payments support beneficiaries' access to innovations that actually improve outcomes compared to existing treatments. For the complete story, visit STAT+.