CMS Introduces HCPCS Code for Ultromics EchoGo® Heart Failure, Enhancing HFpEF Detection Access

HCPCS code C9786 can now be used for billing artificial intelligence to aid the detection of Heart Failure with Preserved Ejection Fraction (HFpEF).

CMS established a new HCPCS code (C9786) in the Hospital Outpatient Prospective Payment System (OPPS) for Ultromics' technology with the following descriptor "Echocardiography image post processing for computer aided detection of Heart Failure with Preserved Ejection Fraction, including interpretation and report," designated for Medicare beneficiaries receiving the service in the hospital outpatient setting. The new HCPCS code went into effect on July 1st, 2023.

EchoGo® Heart Failure is the first US Food and Drug Administration (FDA) cleared platform for detecting Heart Failure with Preserved Ejection Fraction (HFpEF), using a single view of an echocardiogram. The platform has the potential to catch disease earlier and get more patients on the pathway to treatment.

CMS's position is supported by clinical evidence presented at the American Society of Echocardiography (ASE) 2023 Scientific Sessions, demonstrating the effectiveness of EchoGo® Heart Failure for the detection of HFpEF. Combined with clearance and Breakthrough Device Designation by the FDA, providers can have trust and confidence in Ultromics' ability to deliver effective and innovative solutions for heart failure care.

"This is a major milestone and will enable hospitals to accelerate the adoption of EchoGo® Heart Failure, to improve detection of HFpEF within their systems" said Dr. Ross Upton, CEO and Founder of Ultromics. "Given the prevalence of HFpEF, this is a significant development toward recognizing and detecting a heavily underdiagnosed condition."

As many as 50 percent of heart failure cases in the United States are HFpEF.¹ Patients with HFpEF are difficult to identify, and greater awareness of the condition and clearer diagnostic pathways are needed.² According to a JACC Scientific Statement on HFpEF, up to 64% of patients go undiagnosed.²

EchoGo® Heart Failure is an AI-enabled device that automatically analyses patient scans from a minimally invasive echocardiogram. It contains an AI algorithm, that once activated, screens for HFpEF. The technology can automate the detection process for a complex clinical syndrome where diagnosis is often uncertain, resulting in more patients getting a correct and expeditious diagnosis.

The assigned HCPCS code (C9786) brings Ultromics one step closer to transforming cardiovascular care and solidifying its position as a leader in the field. With these codes in place, it opens the door for the adoption of EchoGo® Heart Failure to empower healthcare providers with cutting-edge technology and the potential to improve patient outcomes.

EchoGo® Heart Failure received FDA clearance in the USA in December 2022. The device is available in the United States.