STAT+: The last ‘breakthrough’ devices to get special treatment from Medicare

In the last month, manufacturers have announced FDA “breakthrough” status for a variety of devices, including triage algorithms for abdominal CT scans, diagnostic panels for urinary tract infections, and thrombectomy robots. These designations are arriving just under the wire: as of October, new breakthrough-designated devices will no longer be eligible for special treatment when qualifying for extra Medicare payments.

The latest update of STAT’s Breakthrough Device Tracker includes these devices and more than a dozen others; since 2022, the tracker has captured nearly 800 devices reported to have FDA breakthrough status.

In August, the Centers for Medicare and Medicaid Services finalized the removal of pathways that had made it easier for breakthrough devices to qualify for supplementary Medicare payments for both inpatient and outpatient use. Since 2020, devices that received FDA breakthrough designation could qualify for new technology add-on payments and transitional pass-through payments without proving they provided a substantial clinical improvement over alternatives, or that they were new.

The change ends that reimbursement advantage for devices designated after October, likely reducing the Medicare payment benefit tied to the breakthrough designation and explaining the recent rush of announcements.