Photo: EkoHealth
Overview
CMS’ new payment rate for Eko Health’s AI-assisted cardiac exam signals growing federal support for AI in routine care, as more tools secure coverage and lawmakers push for broader reimbursement pathways.
Medicare will start paying hospitals that use an AI-powered device to screen for heart disease during routine checkups, a move that signals a shift in how federal regulators view AI in everyday clinical care. The change is expected to shape how quickly these tools reach patients and influence how biotech leaders working in AI-based diagnostics plan their next steps.
Eko Health announced on Dec. 2 that Centers for Medicare & Medicaid Services (CMS) finalized a national payment rate for its AI-assisted cardiac exam, performed with its digital stethoscope. The ruling, part of the 2026 Hospital Outpatient Prospective Payment System, means hospitals can now bill Medicare when doctors use the company’s platform, called Sensora, to screen for problems like heart failure and irregular heartbeat.
It’s not the only AI tool to secure Medicare coverage in recent weeks. Caristo Diagnostics secured reimbursement for its AI-based heart scan analysis, also starting Jan. 1, 2026. Additionally, lawmakers have introduced bipartisan bills that would create a dedicated Medicare payment track for additional AI-driven healthcare services.
“Over the past year, we have watched clinicians go from curious to confident as they see how AI can surface issues that might otherwise be missed,” Jason Bellet, Chief Business Officer and Co-founder at Eko Health, told Cure. “With this hospital outpatient reimbursement in place, we expect more health systems to bring Sensora into everyday practice.”
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Wide Gap Between Approval and Reimbursement
While the number of AI medical devices approved by the FDA has nearly doubled to 950 in the past two years, only 23 have reimbursement, according to an industry analysis. The pace of billing codes is accelerating, with more than 40% of those decisions arriving in 2025.
Lawmakers are also taking aim at the gap. The Health Tech Investment Act, introduced in April by Sens. Mike Rounds and Martin Heinrich, would assign FDA-cleared AI devices to a new technology payment classification for at least five years while CMS gathers cost data.
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Solving for the Leading Cause of Death
Eko’s Sensora works with the company’s digital stethoscopes to help doctors spot early signs of heart failure, valve disease, and atrial fibrillation in seconds during a standard exam. The system’s algorithms analyze heart sounds and rhythm in real time and flag potential problems for follow-up.
Heart disease remains the leading cause of death in the United States, responsible for nearly one in five deaths, according to the Centers for Disease Control and Prevention (CDC). Many conditions go unnoticed until symptoms progress, so companies like Eko aim to identify early warning signs when more treatment options are available.
Bellet said more hospitals and clinicians are recognizing how AI can support early detection, after spending time testing the technology and seeing its potential to help patients.
“Over the past year, the mindset among clinicians has shifted,” Bellet said. “With more pilot results, more AI tools receiving formal recognition, and clearer reimbursement signals, clinicians are now saying, ‘This is ready for routine care.’ Hospitals are no longer asking if they should use AI for detection. They’re asking how quickly they can roll it out to the front line of care.”
