American Medical Association (AMA) Grants Cardio Diagnostics a Dedicated CPT PLA Reimbursement Code for Epi+Gen CHD, an AI-powered Test for Assessing the Probability of a Heart Attack or Coronary Heart Disease Event

Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the American Medical Association (AMA) has granted and assigned a dedicated Current Procedural Terminology (CPT) Proprietary Laboratory Analysis (PLA) code, 0439U, for the company’s AI-driven coronary heart disease (CHD) event risk assessment test, Epi+Gen CHD.

Receipt of this new CPT PLA code, which will be effective on April 1, 2024, is a significant step toward payer billing and payment, facilitating broader adoption of the first and only AI-powered integrated genetic-epigenetic clinical blood test for evaluating the likelihood of a patient experiencing a CHD event, mainly a heart attack, within the next three years.

Primary Prevention of Heart Attacks: The Clinical and Economic Benefits of Epi+Gen CHD

Every year, about 805,000 people in the United States have a heart attack, with someone experiencing a heart attack every 40 seconds. Heart disease is the leading cause of death for both men and women. In 2021, heart disease was responsible for the deaths of more than 695,000 Americans. Of those deaths, 310,661 occurred in women, which represents one in every five female deaths.

There are challenges in detecting women’s heart disease because, according to Johns Hopkins Medicine, women’s heart disease symptoms and signs can be atypical, which delays understanding of their risks for a heart attack. Epi+Gen CHD evaluates an individual’s unique genetic and epigenetics to predict their risk for a heart attack or sudden cardiac death associated with CHD with unrivaled personalized insights driven by the company’s groundbreaking epigenetic-genetic technology. By leveraging the power of AI, the company’s technology can provide patient-specific epigenetic and genetic drivers of CHD to help guide preventive care and potentially save lives.

In peer-reviewed studies, Epi+Gen CHD was more cost-effective and more sensitive for assessing heart attack risk compared to standard lipid-based risk calculators. Specifically, in a validation study conducted with Intermountain Healthcare, Epi+Gen CHD was shown to be, on average, about twice as sensitive in detecting risk for a CHD event in women than lipid-based calculators.

Enhancing Employer Risk Mitigation Strategies with Epi+Gen CHD

For employers, the financial burden of heart attacks includes direct costs related to diagnosing, managing and treating heart disease, as well as indirect costs such as lost productivity due to employee absenteeism and short-term disability. Employee absenteeism and short-term disability resulting from cardiovascular disease can cost employers about $1,119 more in the first month following a cardiovascular event. The cardiovascular health of U.S. employees costs $363 billion annually, including $216 billion in direct medical costs and nearly $147 billion in indirect costs.