New CMS Decision Provides Medicare Coverage for the Clinical Use of the Tempus ECG-AF Device
Tempus AI (NASDAQ: TEM) announces a significant Medicare coverage decision for its ECG-AF device. The Centers for Medicare and Medicaid Services (CMS) will provide reimbursement for cardiac dysfunction assessments using the Tempus ECG-AF algorithm, with a Medicare rate of $128.90 effective January 1, 2025.
The FDA-cleared device analyzes 12-lead ECG recordings to detect signs of atrial fibrillation (AF) risk within 12 months for patients 65 and older. This development follows Tempus' earlier FDA 510(k) clearance, marking the first AF indication in cardiovascular machine learning-based notification software. With nearly one million Americans having undetected AF and over 100 million ECGs performed annually in the U.S., this AI-powered solution aims to enhance early disease detection.
Tempus AI (NASDAQ: TEM) annuncia una decisione significativa riguardante la copertura Medicare per il suo dispositivo ECG-AF. I Centri per i Servizi Medicare e Medicaid (CMS) forniranno un rimborso per le valutazioni della disfunzione cardiaca utilizzando l'algoritmo ECG-AF di Tempus, con una tariffa Medicare di $128,90 a partire dal 1 gennaio 2025.
Il dispositivo approvato dalla FDA analizza le registrazioni ECG a 12 derivazioni per rilevare segnali di rischio di fibrillazione atriale (AF) entro 12 mesi per i pazienti di 65 anni e oltre. Questo sviluppo segue l'approvazione precedente della FDA 510(k) da parte di Tempus, segnando la prima indicazione di AF nel software di notifica basato su machine learning cardiovascolare. Con quasi un milione di americani che hanno AF non diagnosticata e oltre 100 milioni di ECG effettuati annualmente negli Stati Uniti, questa soluzione potenziata dall'IA mira a migliorare la rilevazione precoce della malattia.
Tempus AI (NASDAQ: TEM) anuncia una decisión significativa sobre la cobertura Medicare para su dispositivo ECG-AF. Los Centros de Servicios Medicare y Medicaid (CMS) proporcionarán reembolso para evaluaciones de disfunción cardíaca utilizando el algoritmo ECG-AF de Tempus, con una tasa de Medicare de $128.90 efectiva a partir del 1 de enero de 2025.
El dispositivo aprobado por la FDA analiza grabaciones de ECG de 12 derivaciones para detectar signos de riesgo de fibrilación atrial (AF) en pacientes de 65 años o más en un plazo de 12 meses. Este desarrollo sigue a la aprobación anterior de Tempus por la FDA 510(k), marcando la primera indicación de AF en software de notificación basado en aprendizaje automático cardiovascular. Con casi un millón de estadounidenses con AF no diagnosticada y más de 100 millones de ECG realizados anualmente en EE. UU., esta solución impulsada por IA tiene como objetivo mejorar la detección temprana de enfermedades.
템퍼스 AI (NASDAQ: TEM)가 ECG-AF 장치에 대한 중요한 Medicare 보장 결정을 발표했습니다. 메디케어 및 메디케이드 서비스 센터(CMS)는 Tempus의 ECG-AF 알고리즘을 사용한 심장 기능 장애 평가에 대해 $128.90의 메디케어 요금을 2025년 1월 1일부터 제공할 예정입니다.
FDA 승인을 받은 이 장치는 12리드 ECG 기록을 분석하여 65세 이상의 환자에서 12개월 이내에 심방 세동(AF) 위험 신호를 감지합니다. 이 개발은 Tempus의 이전 FDA 510(k) 승인을 따르며, 심혈관 기계 학습 기반 알림 소프트웨어에서의 첫 번째 AF 지표를 나타냅니다. 거의 100만 명의 미국인이 진단되지 않은 AF를 앓고 있으며, 매년 미국에서 1억 회 이상의 ECG가 수행되는 만큼 이 AI 기반 솔루션은 조기 질병 감지를 개선하는 것을 목표로 하고 있습니다.
Tempus AI (NASDAQ: TEM) annonce une décision de couverture Medicare significative pour son dispositif ECG-AF. Les Centres Medicare et Medicaid Services (CMS) fourniront un remboursement pour les évaluations de dysfonction cardiaque utilisant l'algorithme ECG-AF de Tempus, avec un tarif Medicaid de 128,90 $ à compter du 1er janvier 2025.
Le dispositif approuvé par la FDA analyse des enregistrements ECG à 12 dérivations pour détecter des signes de risque de fibrillation auriculaire (AF) chez les patients de 65 ans et plus dans un délai de 12 mois. Ce développement fait suite à l'approbation antérieure de Tempus par la FDA 510(k), marquant la première indication d'AF dans un logiciel de notification basé sur l'apprentissage machine cardiovasculaire. Avec près d'un million d'Américains présentant une AF non détectée et plus de 100 millions d'ECG réalisés chaque année aux États-Unis, cette solution alimentée par l'IA vise à améliorer la détection précoce des maladies.
Tempus AI (NASDAQ: TEM) gibt eine bedeutende Medicare-Versorgungsentscheidung für sein ECG-AF-Gerät bekannt. Die Centers for Medicare and Medicaid Services (CMS) werden die Kosten für Beurteilungen von Herzfunktionsstörungen mit dem Tempus ECG-AF-Algorithmus übernehmen, mit einem Medicare-Satz von 128,90 USD, der ab dem 1. Januar 2025 gültig ist.
Das von der FDA zugelassene Gerät analysiert 12-Kanal-EKG-Aufzeichnungen, um innerhalb von 12 Monaten Anzeichen eines erhöhten Risikos für Vorhofflimmern (AF) bei Patienten ab 65 Jahren zu erkennen. Diese Entwicklung folgt der früheren FDA-Zulassung 510(k) von Tempus und markiert die erste AF-Indikation in einer kardiovaskulären Software zur Benachrichtigung auf Basis von maschinellem Lernen. Da fast eine Million Amerikaner an unentdecktem AF leiden und jährlich über 100 Millionen EKGs in den USA durchgeführt werden, zielt diese KI-gestützte Lösung darauf ab, die frühzeitige Krankheitsdiagnose zu verbessern.
- Medicare coverage approval with $128.90 reimbursement rate starting January 2025
- First FDA-cleared AF indication in cardiovascular machine learning notification software category
- Addresses large market opportunity with over 100 million annual U.S. ECGs
- Coverage implementation delayed until January 2025
- Device to patients 65 years and older
- Cannot be used as sole basis for AF diagnosis or treatment decisions
Insights
New decision establishes reimbursement for the clinical use of Tempus ECG-AF, reducing the financial burden of using AI to improve early detection of atrial fibrillation
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
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
“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.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the potential for Tempus’ ECG-AF device to support physicians and clinicians in finding patients who are at risk for cardiovascular disease and conditions earlier; the expected benefits of such earlier identification of patients; Tempus’ belief that patients at the risk of AF are underdiagnosed and undertreated; and AF-related patient population; and suitability of claim submission for any specific patient; decisions made by CMS regarding coverage, coding, or reimbursement for use of the ECG-AF device. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.
You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.
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
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Erin Carron
media@tempus.com
773-612-4414
Source: Tempus AI, Inc.
FAQ
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