In a landmark progression for AI-driven healthcare, the Centers for Medicare & Medicaid Services (CMS) has confirmed that Tempus’s AI-based ECG‑AF algorithm will be reimbursable under Medicare beginning January 1, 2025. This milestone follows the algorithm’s FDA 510(k) clearance earlier this year and positions it among the first machine-learning-based cardiovascular diagnostic tools to receive such support. The reimbursement applies to hospital outpatient settings under new CPT codes—0764T and 0765T—categorized in APC 5734, which sets the Medicare rate at approximately $129 per assessment.

Tempus’s ECG‑AF tool analyzes standard 12‑lead ECG recordings from patients aged 65 and older who lack a history of atrial fibrillation or related conditions. Through machine-learning models trained on vast ECG datasets, the algorithm predicts AF occurrence within the next 12 months—reportedly identifying risk in about one in five patients with a positive result.

By empowering clinicians with early detection insights, the tool seeks to bridge a critical diagnostic gap: nearly one million Americans are estimated to have undiagnosed atrial fibrillation—a condition strongly linked to stroke and heart failure.

Healthcare leaders see this CMS decision as transformative. Not only does it address barriers to clinical adoption—by aligning with reimbursement and regulatory frameworks—but it also signals growing confidence in AI-driven diagnostics. According to Brandon Fornwalt, Tempus’s Senior VP of Cardiology, the combined forces of FDA clearance and CMS acceptance significantly ease the adoption of such tools in clinical practice.

This development arrives alongside a broader surge in AI‑ECG innovations: numerous vendors secured regulatory approval or reimbursement tracks in 2024, including solutions targeting low ejection fraction, arrhythmias, and structural heart disease. But Tempus’s ECG-AF stands out—not just for predicting future disease risk, but for gaining inclusion in Medicare’s reimbursement schedule, marking a tangible shift toward widespread clinical use.

As the healthcare landscape evolves, earlier disease identification through AI promises to reshape care pathways—not only in cardiology but across diagnostic medicine. With Medicare now on board, clinicians have a stronger incentive to deploy intelligent screening tools, potentially reducing the burden of stroke and other complications through timely intervention.