Kardia 12L ECG System Receives CMS Reimbursement Approval

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.

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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., the leading provider of FDA-cleared personal electrocardiogram (ECG) technology, is transforming cardiology with its medical-grade AI solutions. AliveCor is committed to providing innovative devices and services that empower patients and physicians with personalized and actionable heart data. With over 250 million ECGs recorded, the company’s Kardia devices are the most clinically validated personal ECGs in the world and can remotely detect six of the most common heart arrhythmias in just 30 seconds. The company’s latest offering, Kardia 12L ECG System, powered by KAI 12L to detect 35 cardiac conditions (14 arrhythmias and 21 morphologies), was designed exclusively for use by healthcare providers. AliveCor’s enterprise platform allows third-party providers to manage their patients’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies, addressing gaps in care and improving the treatment experience for patients across a range of disease areas. AliveCor is a privately held company headquartered in Mountain View, Calif. For more information, visit alivecor.com and follow us on LinkedIn, X, Instagram and Facebook.

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SOURCE AliveCor, Inc.