MOUNTAIN VIEW, Calif., Jan. 16, 2025 /PRNewswire/ -- AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced that the Centers for Medicare & Medicaid Services (CMS) has included the company's AI-powered ECG technology in the 2025 Hospital Outpatient Prospective Payment System (OPPS) final rule, assigning it to Ambulatory Payment Classification (APC) 5733. This approval enables hospital outpatient settings to receive a Medicare payment rate of $59.40 when the FDA-cleared Kardia™ 12L ECG System is used to perform 12-lead ECGs.
"Cardiovascular disease remains the leading cause of death in the U.S., and CMS's decision to set a Medicare payment rate for the AI-powered ECG represents a major step toward broadening access to this potentially life-saving heart health technology," said Sanjay Voleti, chief business officer of AliveCor. "By leveraging advanced AI to diagnose more conditions than ever, the reliable and easy-to-use Kardia 12L ECG System sets a new standard in cardiac care, democratizing access to critical heart data and highlighting the value of widespread ECG use in clinical practice."
This approval is in addition to the Category III Current Procedural Terminology (CPT) codes that were granted by the American Medical Association (AMA) for government payers, including Medicare and Medicaid, and commercial insurance companies to identify healthcare services and procedures for reimbursement.
For more information, please visit the coding guide.
About Kardia 12L ECG and KAI 12L AI Technology
Kardia 12L ECG System combines the power of KAI 12L's AI technology and the pocket-sized Kardia 12L, to enable faster, easier detection of life-threatening cardiac conditions. KAI 12L is the world's first AI to detect 35 cardiac determinations, including heart attacks, using a reduced leadset.
Kardia 12L ECG System is battery-operated, weighs just 0.3 pounds – making it significantly smaller, more portable and easier to use than conventional 12-lead ECGs. Its streamlined leadset also makes it less invasive for patients, who do not need to fully disrobe during a reading. The device requires minimal self-guided training and is simpler and faster to use than standard 12-lead ECG machines. These features put 12-lead ECG data within reach of more healthcare providers than ever before in a variety of healthcare facilities and acute settings, including primary and urgent care offices, employer clinics, and other under-resourced or rural venues.
For healthcare providers interested in purchasing a Kardia 12L, please visit alivecor.com/products/kardia12L.
About AliveCor
AliveCor, Inc. is pioneering the creation of FDA-cleared ‘machine learning’ techniques to enable proactive heart care and is recognized around the world for transforming cardiac care. The FDA-cleared Kardia Mobile is the most clinically validated mobile ECG solution on the market and is recommended by leading cardiologists and used by people worldwide for accurate ECG recordings. This simple-to-use mobile device and app-based service provides instant analysis for detecting atrial fibrillation (AF) and normal sinus rhythm in an ECG. Kardia Pro is the first AI-enabled platform for doctors to monitor patients for the early detection of atrial fibrillation, the the most common cardiac arrhythmia that leads to a five times greater risk of stroke. AliveCor was recognized by Fast Company as one of 2017’s most innovative companies in health (#3). AliveCor is a privately-held company headquartered in Mountain View, Calif. For more information, please visit alivecor.com.