In a landmark move for digital health and clinical diagnostics, the Centers for Medicare & Medicaid Services (CMS) announced on 16 November 2024 that AI-enhanced electrocardiogram (ECG) technologies will be eligible for outpatient reimbursement under the 2025 Hospital Outpatient Prospective Payment System (OPPS). This decision marks a significant milestone for companies developing AI algorithms to detect cardiac abnormalities, including low ejection fraction and atrial fibrillation.

Among the beneficiaries are Anumana, HeartSciences, and Eko Health—each of which has developed FDA-cleared or pending AI-ECG platforms. Anumana’s algorithm for detecting low ejection fraction is already FDA-approved, while HeartSciences’ MyoVista wavECG™ and MyoVista Insights™ are awaiting regulatory clearance. Eko Health’s SENSORA platform, which integrates with its CORE 500 digital stethoscope, has been assigned Category III CPT codes effective July 2025, enabling broader clinical use and data collection.

These technologies represent a shift toward more proactive, decentralized cardiac care. By embedding AI into wearable or portable devices, clinicians can detect subtle cardiac dysfunctions earlier and more accurately—potentially reducing hospitalizations and improving long-term outcomes.

The CMS decision is expected to catalyze further innovation and investment in AI-powered diagnostics. It also aligns with broader trends in clinical research favoring patient-centric, tech-enabled trial designs. As reimbursement becomes viable, clinical trials incorporating these tools may see faster enrollment, richer datasets, and improved endpoints.

This development underscores the growing convergence of regulatory policy, artificial intelligence, and clinical research—a triad that could redefine how cardiovascular trials are conducted and how care is delivered.