STAT+: The last ‘breakthrough’ devices to get special treatment from Medicare
New medical devices deemed "breakthrough" by the FDA are no longer automatically eligible for extra Medicare payments.
In the recent month, pharmaceutical companies have unveiled a variety of "breakthrough" devices that have received approval from the FDA. These devices encompass a range of applications, such as triage algorithms for abdominal CT scans, diagnostic panels for urinary tract infections, and thrombectomy robots. The timing of this announcement is noteworthy as, as of October, new devices designated as breakthrough will no longer be eligible for special treatment in terms of receiving additional Medicare payments.
This change was finalized in August by the Centers for Medicare and Medicaid Services. The decision to remove these pathways comes after being in effect since 2020, which allowed breakthrough devices to qualify for both supplementary Medicare payments for inpatient and outpatient use without the need to demonstrate substantial clinical improvement over existing alternatives or being a novel invention.
As of the latest update to STAT's Breakthrough Device Tracker, which has been tracking nearly 800 devices with FDA breakthrough status since 2022, a significant number of these devices will lose their special treatment eligibility for Medicare payments. This development could potentially impact the financial incentives for manufacturers to invest in the development of these devices, as they may no longer receive the same level of reimbursement for their innovations.
Written by urgent.news from STAT News's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
