New CMS decision allows Medicare coverage of TempusECG-AF device

Tempus AI (TEM) announced the impact of a new decision by the Centers for Medicare and Medicaid Services CMS that will allow reimbursement for assessments of cardiac dysfunction using the Tempus ECG-AF algorithm. ECG-AF is one of just a few FDA-authorized medical technologies in the country to be impacted by the new CMS decision, and this milestone allows Tempus to more broadly support clinicians in identifying patients at increased risk of atrial fibrillation/flutter AF. Per the CMS policy to allow payment for certain Software as a Service or SaaS, devices in the Hospital Outpatient setting, CMS has assigned associated procedure codes for assessments with assistive algorithms like Tempus’ ECG-AF to APC 5734, which has a Medicare rate of $128.90, effective January 1. This ruling is expected to allow hospitals to receive reimbursement for using Tempus’ ECG-AF to help identify patients at increased risk of AF. Earlier this year, Tempus received 510(k) clearance from the FDA for the Tempus ECG-AF device, which was the first FDA clearance for an AF indication in the category known as “cardiovascular machine learning-based notification software” and paved the way for clinicians to use this innovative algorithm in the care of their patients.