CMS Approves NTAP Reimbursement for AI-Powered EchoGo Heart Failure System

Use of the artificial intelligence (AI)-enabled EchoGo® Heart Failure system (Ultromics) during an acute hospital in-patient stay for Medicare beneficiaries may be reimbursed up to $1,023.75, according to a recent decision by the Centers for Medicare and Medicaid Services (CMS).

The new technology add-on payment (NTAP) reimbursement is reportedly the first approved by the CMS for an AI-based heart failure detection system, according to Ultromics. The company said the NTAP reimbursement will be effective for use of the EchoGo Heart Failure system on or after October 1, 2023.

The EchoGo Heart Failure system, which can reportedly diagnose heart failure with preserved ejection fraction (HFpEF) through analysis of a single echocardiogram view, received FDA 510(k) clearance in December 2022. Last month, the EchoGo Heart Failure system was issued an HCPCS code (C9786) by CMS for use of the technology in outpatient settings.

“We are honored that CMS approved EchoGo Heart Failure for NTAP and are eliminating financial hurdles that would have prevented Medicare beneficiary access to this breakthrough technology,” noted Ross Upton, Ph.D., the chief executive officer and founder of Ultromics. “ … In the (United States), HFpEF is a leading cause of mortality and accounts for more than half of all heart failure cases, but it remains challenging to diagnose. More precise detection can help improve diagnosis and outcomes.”

The NTAP reimbursement approval comes on the heels of a recently published study in JACC:Advances, which found 97 percent and 95 percent area under receiver-operating characteristic curves (AUCs) for training and validation of the EchoGo Heart Failure system for automated detection of HFpEF.

In addition to demonstrating a sensitivity rate of 87.8 percent and a specificity rate of 81.9 percent in clinically relevant subgroups, the study authors noted that the EchoGo Heart Failure system successfully reclassified 571 out of 776 patients (73.6 percent) who had non-diagnostic outcomes with the Heavy, Hypertensive, Atrial Fibrillation, Pulmonary Hypertension, Elder, and Filling Pressure (H2FPEF) score. For the reclassified patients, the EchoGo Heart Failure system demonstrated a sensitivity rate of 84 percent and a specificity rate of 78.3 percent, according to the researchers.

Use of the EchoGo Heart Failure system for HFpEF screening “ … has the potential to automate an accurate detection process for a complex clinical syndrome,” wrote study co-author Patricia A. Pellikka, M.D., vice-chair of the Department of Cardiovascular Medicine at the Mayo Clinic in Rochester, Minn., and colleagues.