OXFORD,
England, July 2, 2024 /PRNewswire/ -- Ultromics
announced today that the American Medical Association (AMA) has
issued a Category III Current Procedural Terminology (CPT) code for
EchoGo® Heart Failure, a crucial advancement in enhancing the
accessibility of Ultromics' ground-breaking technology in hospital
outpatient settings.
EchoGo® Heart Failure uses AI to detect heart failure
with preserved ejection fraction (HFpEF) from a single, routinely
acquired echocardiographic video. The technology leverages large
datasets and advanced algorithms to identify patterns and
correlations that may go undetected by traditional diagnostic
methods. The AI insights aid clinicians in diagnosis, monitoring,
and expediting treatment responses, significantly enhancing the
detection and management of patients with this challenging subtype
of heart failure.
This is the only artificial intelligence CPT code specific to
supporting HFpEF diagnosis through echocardiography and was
released on July 1st this
year on the AMA's website, becoming effective January 1st, 2025. The new CPT code,
0923T, will replace the previous HCPCS outpatient code for
EchoGo® Heart Failure, C9786.
EchoGo® Heart Failure is also covered in the hospital
inpatient setting, using the New Technology Add-on Payment (NTAP)
code XXE2X19.
Ross Upton, PhD, Chief Executive
Officer and founder of Ultromics, stated, "This recognition by the
AMA underscores the significant impact our technology is having in
the field of heart failure care. HFpEF represents a significant and
growing patient population, accounting for 50% of heart failure
cases worldwide, and may go undiagnosed in up to 64% of
cases.1 We believe that EchoGo® Heart
Failure will transform diagnostic pathways for these patients,
enable earlier intervention, improve quality of life, and deliver
benefits to payors and healthcare systems."
In the US, CPT codes are used by public and private health
insurance programs and offer doctors and healthcare professionals a
method to identify medical services and procedures for
reimbursement. Category III CPT codes are temporary codes assigned
to new and developing technologies, procedures, and services.
Additional Data on EchoGo® Heart Failure
EchoGo® Heart Failure was granted FDA 510(k)
clearance in December 2022 and has
been awarded FDA Breakthrough Device Designation.2
Recent data on the tool was published last year in JACC:
Advances, showing superior efficacy of EchoGo® Heart
Failure in identifying HFpEF over the current clinical
standard.
Specifically, the AI-based system was able to correctly assign a
diagnosis to 74% of patients who had returned non-diagnostic
results on the commonly used HFA-PEFF and H2FPEF clinical
scores.3 This improvement could translate to more
patients receiving accurate and timely diagnoses and
management.
EchoGo® Heart Failure demonstrated high sensitivity
and specificity, detecting 88% of patients who had HFpEF, and 82%
of patients that did not.3 These results exceed what is
usually observed in routine clinical practice.
For the study, investigators retrospectively assessed
independent data on 6,756 patients who underwent a comprehensive
TTE at Mayo Clinic in Rochester,
Minnesota, between January
2009 and December 2020. It was
then independently tested in geographically distinct areas within
Mayo Clinic Enterprise sites across the
United States on a dataset that included 1,284 patients.
The authors concluded, "EchoGo® Heart Failure's
exceptional discrimination capabilities, combined with its ability
to identify patients with higher mortality risks, hold great
promise for improving patient outcomes and enabling faster access
to treatment."
References:
1. Borlaug et al., Heart Failure With Preserved Ejection
Fraction: JACC Scientific Statement. J Am Coll Cardiol
2023;81:1810–1834.
2. Ultromics receives FDA Clearance for its Breakthrough Device
EchoGo Heart Failure: An AI-based platform that enables precision
detection of heart failure with preserved ejection fraction. News
release. Ultromics. December 2,
2022.
3. Akerman AP, et al. Automated Echocardiographic Detection of
Heart Failure with Preserved Ejection Fraction Using Artificial
Intelligence. JACC Adv. 2023:1;2(6):100452–2.
About Ultromics:
Ultromics is a pioneer in precision heart failure detection. Our
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 dataset in
echocardiography. The model was trained on thousands of patients to
accurately detect disease and was validated against 5-year patient
outcomes. The technology has been built in collaboration with
Mayo Clinic and the NHS England. Ultromics' mission is to stop
heart failure in its tracks with its precision detection
platform.
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