American Medical Association (AMA) Grants Prevencio Three CPT® PLA Reimbursement Codes for Novel AI-driven Cardiac HART® Blood Tests

Receipt of dedicated CPT® codes mark important commercialization milestone to pursue reimbursement for Prevencio’s multi-protein HART CADhs®, HART CVE®, and HART KD® Blood Tests

KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc., The AI-driven Cardiac Company™, today announces that the American Medical Association (AMA) has assigned three new, dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analysis (PLA) codes to facilitate billing and payment for its three lead tests. The company’s HART CADhs® is a multi-protein diagnostic test for determining whether a patient has heart disease and may be at imminent risk of a heart attack. HART CVE® is a multi-protein risk test for a patient’s one-year risk of heart attack, stroke, or cardiac death, and HART KD® is a multi-protein diagnostic test for Kawasaki disease, the first and only diagnostic test available.

The establishment of the new codes is a result of the AMA’s PLA program, which enables companies and labs with distinct, single-source Laboratory Developed Tests (LDT) to apply for dedicated codes that can be utilized to bill payors to receive reimbursement. The codes were included in the revised set of PLA codes the AMA released on December 30, 2021, with effective dates of April 1, 2022.

The AMA assigned the new code 0308U for HART CADhs®, 0309U for HART CVE®, and 0310U for HART KD®. Each code is specific to these proprietary, patented tests.

“The receipt of these dedicated CPT® PLA codes are an important milestone in our commercial strategy to establish coding, coverage and payment for our proprietary HART® Tests,” said Rhonda F. Rhyne, President and Chief Executive Officer of Prevencio, Inc. “We believe that the HART® Tests have important roles in safely, cost-effectively, and accurately diagnosing obstructive heart disease and Kawasaki disease as well as improving cardiac risk identification. The HART® Tests allow earlier, proactive interventions aimed at decreasing adverse outcomes and thereby reducing healthcare costs. We are committed to making our tests broadly accessible. These CPT® PLA codes are a critical step in our efforts to secure reimbursement from individual employer-sponsored, commercial, and Medicaid health plans.”

Cardiovascular disease is the leading cause of death in the U.S. and globally. According to the American Heart Association, the U.S. spends approximately $316 billion annually on cardiovascular disease and stroke, or approximately 10% of the $3.2 trillion spent on total healthcare. By 2030, more than 40% of the U.S. adult population is projected to have cardiovascular disease. For additional information on Prevencio’s HART® Tests, visit Prevencio, Inc.

About Prevencio HART Tests: Powered by AI, Prevencio is revolutionizing blood tests for cardiovascular disease and custom diagnostics. Employing this novel approach, the Company has developed seven blood tests that significantly improve diagnosis and risk assessment for a variety of heart and blood vessel-related complications.

Our three lead tests include:

  1. HART CVE® – 1-year risk of heart attack, stroke, or cardiac death
  2. HART CADhs® – obstructive coronary artery disease diagnosis
  3. HART KD® – Kawasaki disease diagnosis

HART test results have been peer-reviewed published 27 times, including at leading cardiovascular meetings—(European Society of Cardiology Congress – 2016, 2018, 2021; American College of Cardiology Scientific Sessions – 2017, 2018, 2019 (2), 2020, 2021; American Heart Association Scientific Sessions – 2017, 2018, 2019, 2021; American Diabetes Association Scientific Sessions – 2018, 2019; Pediatric Academic Societies International Sessions – 2021; International Spinal Cord Society Scientific Sessions –2021; ASTRO Scientific Sessions – 2021; International Kawasaki Disease Symposium – 2021) and in top-tier journals—(Journal of American College of Cardiology – Mar 2017; American Journal of Cardiology – July 2017; Clinical Cardiology – June 2018; Open Heart – November 2018, May 2019; Jan 2019; Biomarkers in Medicine – June 2020; Journal of American Heart Association – Aug 2020).

About Prevencio, Inc.:

Prevencio’s value proposition is “Preventing the Preventable” — That is, preventing unnecessary procedures, related side effects, and expense, as well as improving patient outcomes and clinical trials through more accurate blood tests for Cardiovascular Disease conditions. Prevencio utilizes Machine Learning (Artificial Intelligence) + Multi-Proteomic Biomarkers + Proprietary Algorithms to deliver cardiovascular diagnostic & prognostic tests that are significantly more accurate than standard-of-care stress tests, genetic tests, and coronary artery calcium tests. The Company is headquartered in Kirkland, Washington. For additional information, visit Prevencio, Inc.

Forward-Looking (Safe Harbor) Statement:

Except for historical and factual information contained herein, this press release contains forward-looking statements, such as market need, acceptance, and size, the accuracy of which is necessarily subject to various uncertainties of development-stage companies. The Company does not undertake to update disclosures contained in this press release.

Contacts

Christiaan Boer, cboer@cplusc.com; 406-360-5239