New Technology Add-On Payment (NTAP) for Ultromics: Advancing HFpEF Diagnosis

OXFORD, England, Aug. 2, 2023 /PRNewswire/ — Ultromics, a pioneer in advancing heart failure diagnostics through artificial intelligence (AI), has received approval for NTAP from the Centers for Medicare & Medicaid Services (CMS) for its AI system, EchoGo® Heart Failure. This technology is indicated as a diagnostic aid for Heart Failure with Preserved Ejection Fraction (HFpEF) through routine echocardiography assessment. This approval is effective for dates of service on or after October 1, 2023.

The reimbursement opportunity will give healthcare professionals access to advanced technology, which in a new publication in JACC Advances, presented compelling evidence and significant improvement in the detection and management of the complex form of heart failure.

This is the first time CMS has approved an AI-based heart failure diagnostic platform for NTAP. EchoGo® Heart Failure is eligible for reimbursement up to $1,023.75 per acute hospital inpatient stay.

NTAP was established over twenty years ago to support the adoption of cutting-edge technologies that have demonstrated substantial clinical improvement. This incremental payment seeks to eliminate financial disincentives for use on Medicare patients by giving incremental payment to help offset the technology’s cost. In the fiscal year 2024 Inpatient Prospective Payment System final rule, CMS noted that EchoGo® Heart Failure, an FDA-designated Breakthrough Device, has met all the requirements for an NTAP. As a breakthrough device, per the NTAP criteria, EchoGo® Heart Failure automatically meets significant clinical improvement criteria.

“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,” said Ross Upton, PhD., CEO and Founder at Ultromics. “This is another step forward in our early introduction of this transformative technology and in our mission to expand access to our advanced diagnostic support system that addresses a significant unmet need of this complex condition. In the US, 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.”

EchoGo® Heart Failure is a first-of-its kind, fully integrated system that detects heart failure using a single view of an echocardiogram. The platform uses AI to perform a preliminary assessment, analyzing thousands of pixels that go beyond what the eye can see, and provides advanced, critical information to support diagnosis. The technology received breakthrough device designation and commercial clearance for use in the United States by the Food and Drug Administration in 2022.

Hospitals seeking to have access to this potential incremental payment will be able to do so by using a newly established ICD-10-PCS procedure code for the EchoGo Heart Failure NTAP, XXE2X19. This code and the potential for incremental payment are effective starting on dates of service on or after October 1^st, 2023.

To learn more about Ultromics, visit: ultromics.com

About Ultromics:
Ultromics is a pioneer in advanced heart failure detection. The ground-breaking platform, EchoGo ®, is transforming the way heart failure is diagnosed using artificial intelligence and cardiac ultrasound as a modality. The technology empowers clinicians to make precise, efficient, and accurate assessments of heart failure, leveraging the largest known heart disease outcomes dataset in echocardiography, accurately interpreting echocardiograms and predicting cardiac outcomes. The technology has been built in collaboration with Mayo Clinic and NHS England, and has over $50 million raised capital to support continued innovation with the likes of Blue Venture Fund, Optum Ventures, Oxford Science Enterprises, and GV. They are backed by the largest US health insurance firms with 4 FDA clearances. Ultromics’ mission is to stop heart failure in its tracks with its precision detection platform. https://www.ultromics.com

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