Tempus AI, Inc. (NASDAQ: TEM), a leader in AI-driven precision medicine and patient care, today revealed the impact of a recent decision by the Centers for Medicare and Medicaid Services (CMS) to approve reimbursement for cardiac dysfunction assessments using the Tempus ECG-AF algorithm. The ECG-AF is among the few FDA-authorized medical technologies affected by this CMS ruling. This milestone enables Tempus to expand its support for clinicians in identifying patients at higher risk for atrial fibrillation/flutter (AF).
Tempus AI, Inc. (NASDAQ: TEM), a leader in AI-powered precision medicine, announced that the Centers for Medicare and Medicaid Services (CMS) has issued a new ruling that will allow reimbursement for the use of the Tempus ECG-AF algorithm in hospital outpatient settings. As part of this policy, CMS has assigned procedure codes (CPT 0764T and CPT 0765T) to Tempus ECG-AF under APC 5734, which carries a Medicare rate of $128.90, effective January 1, 2025. This ruling enables hospitals to receive payment for using Tempus’ innovative AI algorithm to assess patients at higher risk for atrial fibrillation (AF), a common heart condition that can lead to serious complications like stroke.
This decision follows Tempus’ earlier achievement of receiving FDA 510(k) clearance for its ECG-AF device. The approval marked the first FDA clearance for a machine-learning-based software to detect AF, positioning Tempus as a key player in leveraging AI to advance cardiovascular health. This new policy will make it easier for clinicians to incorporate ECG-AF into their practices, expanding access to early detection and better management of AF, a disease that affects millions of people worldwide.
Cardiovascular disease, particularly AF, continues to be a leading cause of death globally, emphasizing the need for early identification and intervention. AF is a significant risk factor for stroke, yet many individuals remain undiagnosed. It is estimated that nearly one million Americans are living with undetected AF, missing out on optimal treatment opportunities. With over 100 million ECGs performed annually in the U.S., Tempus sees a critical opportunity to enhance the diagnostic power of these routine tests using AI and machine learning. Tempus ECG-AF applies advanced algorithms to these ECGs, enabling clinicians to detect AF risk earlier and more accurately, thus improving patient outcomes.
“We are thrilled with the new Medicare ruling,” said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus. “Combined with our FDA clearance, this policy change significantly lowers the barriers for clinicians to adopt ECG-AF and other innovative technologies, making it easier to address undiagnosed cardiovascular conditions.”
The Tempus ECG-AF algorithm analyzes 12-lead ECG recordings to detect early signs of AF in patients aged 65 and older, who have no known history of AF or related conditions. It helps clinicians assess the likelihood of a patient experiencing AF within the next 12 months. While the results should be used alongside other diagnostic information, such as the patient’s clinical history and symptoms, ECG-AF provides clinicians with an AI-powered tool to proactively manage cardiovascular health. However, the results should not be used alone to diagnose or treat AF.
Tempus is committed to advancing precision medicine through the application of AI in healthcare. By providing clinicians with powerful AI tools, Tempus aims to deliver personalized care and support the discovery and development of optimal therapeutics, benefiting patients worldwide.
