New CMS Decision Provides Medicare Coverage for the Clinical Use of the Tempus ECG-AF Device

Tempus Press Release

December 17, 2024 08:30 AM Eastern Standard Time--CHICAGO--Tempus AI, Inc., a technology company leading the adoption of AI to advance precision medicine and patient care, today 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 (SaaS) devices in the Hospital Outpatient setting, CMS has assigned associated procedure codes for assessments with assistive algorithms like Tempus’ ECG-AF (CPT 0764T and CPT 0765T) to APC 5734, which has a Medicare rate of $128.90, effective January 1, 2025. 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.

Cardiovascular disease remains the leading cause of death globally, making it critical to identify patients at high risk for undiagnosed heart disease much earlier. AF, a common cause of stroke, in particular affects millions of people and can be challenging to diagnose. As a result, nearly one million Americans are believed to have undetected AF, and are missing the opportunity to be treated optimally. Since over 100 million ECGs are performed each year in the U.S.1 there is an opportunity to make these ECG tests “smarter” by applying machine-learning models that can detect risk of certain heart diseases like AF. Tempus ECG-AF provides a solution to help tackle this problem, giving clinicians an AI-based clinical tool to help them be more proactive about earlier disease identification and management.

“We are incredibly excited by this new Medicare ruling,” said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus. “This, combined with our FDA clearance earlier this year, has substantially lowered the barrier for clinicians to broadly adopt innovative technologies like ECG-AF to tackle undiagnosed cardiovascular disease.”

The Tempus ECG-AF algorithm is intended for use to analyze recordings of 12-lead electrocardiogram (ECG) devices and to detect signs associated with a patient experiencing AF within the next 12 months. It is for use on resting 12-lead ECG recordings collected at a healthcare facility from patients 65 years of age or older who do not have a known history of AF or other specified conditions. The device provides clinicians with results that should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history. Tempus ECG-AF does not describe a person’s overall risk of experiencing AF and should not serve as the sole basis for diagnosis of AF. Results should not be used as the basis for treatment of AF and are not intended to rule out AF follow-up. More details on the Tempus ECG-AF technology can be found here.

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

¹ Tison, G. H., Zhang, J., Delling, F. N., & Deo, R. C. (2019). Automated and Interpretable Patient ECG Profiles for Disease Detection, Tracking, and Discovery. Circulation: Cardiovascular Quality and Outcomes, 12(9). https://doi.org/10.1161/circoutcomes.118.005289