The CMS decision to include AI-ECG technology in the 2025 Hospital Outpatient Prospective Payment System will allow reimbursement for cardiac assessments using AI algorithms, increasing access to these tools for detecting heart conditions.

Summary: The Centers for Medicare & Medicaid Services (CMS) has included AI-ECG technology in its 2025 Hospital Outpatient Prospective Payment System final rule, allowing reimbursement for cardiac assessments using algorithms like Tempus’ ECG-AF and Anumana’s ECG-AI. This decision, effective Jan 1, 2025, includes procedure codes for assessments and aims to improve early detection of cardiovascular diseases such as atrial fibrillation (AF).

Key Takeaways:

  1. CMS Inclusion of AI-ECG Technology: CMS will reimburse certain AI-ECG assessments starting Jan 1, 2025, under the OPPS, facilitating broader use of AI-driven tools for cardiac health.
  2. Technologies Covered by CMS: Tempus’ ECG-AF and Anumana’s ECG-AI are two of the AI-driven technologies now covered by CMS reimbursement.
  3. Expanded Access to AI-Driven Diagnostics: The CMS ruling enables wider use of AI-powered ECG technologies in clinical settings.

The Centers for Medicare & Medicaid Services (CMS) has included AI-ECG technology in the 2025 Hospital Outpatient Prospective Payment System final rule under assignment APC 5734.

This will allow reimbursement for assessments of cardiac dysfunction using technology like the Tempus’ ECG-AF algorithm and Anumana’s low ejection fraction ECG-AI.

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 to APC 5734, which has a Medicare rate of $128.90, effective Jan 1, 2025. 

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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. 

Tempus and Anumana’s AI-ECG Technologies

Earlier this year, Tempus received 510(k) clearance from the US Food and Drug Administration 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.”

“We are incredibly excited by this new Medicare ruling,” says Brandon Fornwalt, MD, PhD, senior vice president of cardiology at Tempus, in a release. “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.”

Since over 100 million ECGs are performed each year in the US, there is an opportunity to make these ECG tests “smarter” by applying machine-learning models that can detect the risk of certain heart diseases like AF. 

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. 

Anumana’s ECG-AI technology, which received Category III CPT codes (0764T and 0765T) in 2023, harnesses AI technology to turn standard ECG data into a diagnostic tool for cardiovascular health. By detecting subtle, clinically significant patterns in ECGs that may indicate underlying conditions, ECG-AI aims to assist healthcare providers in making earlier and more accurate diagnoses.

“The new CMS reimbursement ruling reflects our efforts to bring our ECG-AI technology to broader patient populations and recognizes our ongoing leadership in AI-enabled cardiovascular care,” says Maulik Nanavaty, CEO of Anumana, in a release. “This crucial milestone will help to reduce financial barriers to adopting ECG-AI, facilitating a smooth path for its integration into routine care and ultimately improving patient outcomes in cardiovascular disease management.”

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