Medicare ends special payment rules for FDA breakthrough devices starting October
Centers for Medicare and Medicaid Services finalized new rules in August that remove special payment pathways for FDA breakthrough-designated medical devices effective October.
New payment restrictions take effect
As of October, manufacturers can no longer qualify for extra Medicare payments under the previous special treatment program. The Centers for Medicare and Medicaid Services removed the pathways that allowed these devices to bypass standard clinical improvement requirements. This change applies to both inpatient and outpatient use of the technologies.
Recent approvals face deadline
Manufacturers announced breakthrough status for various tools including triage algorithms and thrombectomy robots within the last month. These devices were included in a tracker that has recorded nearly 800 items with FDA designation since 2022. The update ensures that new technologies must now prove substantial clinical improvement to receive supplementary payments.
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