In the last month, manufacturers have announced “breakthrough” status from the Food and Drug Administration for a menagerie of devices: triage algorithms for abdominal CT scans, diagnostic panels for urinary tract infections, and thrombectomy robots, to name a few.
They’re coming in just under the wire: As of October, new breakthrough-designated devices will no longer be eligible for special treatment when it comes to qualifying for extra Medicare payments. These devices, and more than a dozen others, are included in the latest update of STAT’s Breakthrough Device Tracker, which since 2022 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 have made it easier for breakthrough devices to qualify for supplementary Medicare payments for both inpatient and outpatient use. Since 2020, devices that received the designation from the FDA have been able to qualify for new technology add-on payments and transitional pass-through payments without proving they provide a substantial clinical improvement over alternatives, or that they are new.
