AliveCor Wins CMS Reimbursement For 12-Lead ECG

AliveCor has announced that CMS has included its AI-powered Kardia 12L ECG system in a final rule, assigning a Medicare payment rate for the technology. This handheld, battery-operated system, which weighs just 0.3 lbs and uses five electrodes, is designed to simplify the process of obtaining ECG readings. Powered by the KAI 12L AI model, trained on over 1 million recorded ECGs, the device can detect 35 different conditions, including heart attacks and cardiac ischemia. The system was FDA-cleared in mid-2024 and offers eight diagnostic leads, reducing the standard ten-electrode setup, which streamlines the diagnostic process.

CMS has placed the device under Ambulatory Payment Classification (APC) 5733, allowing hospital outpatient settings to receive $59.40 per ECG performed with the Kardia 12L system. AliveCor’s Chief Business Officer, Sanjay Voleti, emphasized that this decision is a major step toward broadening access to critical heart health technology, especially given that cardiovascular disease remains the leading cause of death in the U.S. Voleti also highlighted how the Kardia 12L system, with its advanced AI capabilities, sets a new standard in cardiac care by improving diagnosis and facilitating the widespread use of ECGs in clinical practice. This CMS decision follows Abbott’s recent Medicare win for its CardioMEMS system, another cardiac monitoring technology.