Potential Catalyst Right Around The Corner? CMS To Announce Preliminary Medicare Payment For Cardio Diagnostics' Heart Disease Tests

September 17, 2024 at 09:00 AM EDT

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By James Blacker, Benzinga

Cardio Diagnostics (NASDAQ: CDIO), the company leveraging AI to revolutionize cardiovascular disease prevention with precision epigenetics, is awaiting a crucial decision that could be a major factor in the commercial success of its flagship heart disease tests.

In June of this year, the company attended an annual meeting hosted by the Centers for Medicare and Medicaid Services (CMS), where healthcare companies presented the prices they think Medicare should pay for their products and the rationale for their recommendation. At this meeting, Cardio Diagnostics submitted information and pricing recommendations for its two cutting-edge tests: Epi+Gen CHD and PrecisionCHD.

Now, the company is awaiting the next important step – the CMS is expected to release its proposed payment determinations in September, based on the timeline posted by the CMS on its website. These preliminary determinations are based on the information from said annual meeting, public comments and the recommendations from the Clinical Diagnostic Laboratory Tests (CDLT) Advisory Panel. The final determinations are expected in November.

"Our cutting-edge tests represent a significant advancement in the prevention, detection and management of coronary heart disease, and we are committed to making them accessible to Medicare beneficiaries," stated Meesha Dogan, PhD, CEO and Co-Founder of Cardio Diagnostics.

A Trilogy Of AI-Powered Solutions For Heart Disease

According to the CMS, heart disease is the leading cause of death among Medicare beneficiaries. Coronary heart disease (CHD) is the most common type of heart disease and the primary cause of heart attacks, killing 371,506 people in the U.S. in 2022.

Recognizing the urgent need for advanced diagnostic tools, Cardio Diagnostics has developed state-of-the-art solutions to assess risk for, detect, manage and monitor CHD.

Epi+Gen CHD is an AI-powered blood-based DNA test that evaluates genetic and epigenetic markers to assess the three-year risk for a symptomatic CHD event, while PrecisionCHD aids in diagnosing the condition. Both tests have already been assigned unique CPT codes by the American Medical Association, 0439U and 0440U, respectively, which became effective in April 2024.

Coupled with the Epi+Gen CHD and PrecisionCHD tests is the Actionable Clinical Intelligence (ACI) provider-facing platform, which provides personalized insights by linking the epigenetic and genetic biomarkers evaluated by these tests to the drivers of coronary heart disease.

With the crucial decision from the CMS expected this month, Cardio Diagnostics is on the brink of a breakthrough that has the potential to bring its heart disease tests one step closer to being widely accessible to Medicare patients, potentially saving the lives of millions.

Click here to find out more about Cardio Diagnostics.

Featured photo by Jean-Louis Paulin on Unsplash.

Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine (“Core Technology”) for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. For more information, please visit www.cardiodiagnosticsinc.com.

Certain statements and information included in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, the words or phrases “will”, "will likely result," "expected to," "will continue," "anticipated," "estimate," "projected," "intend," “goal,” or similar expressions are intended to identify "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of the Company. Such uncertainties and risks include but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, dependence on management, dilution to stockholders, lack of capital, the effects of rapid growth upon the Company and the ability of management to effectively respond to the growth and demand for products and services of the Company, newly developing technologies, the Company’s ability to compete, regulatory matters, protection of technology, the effects of competition and the ability of the Company to obtain future financing. An extensive list of factors that can affect future results are discussed in the Current Report on Form 10-K for the period ended December 31, 2022 and Form 10-Q for the period ended March 31, 2023, under the heading “Risk Factors” in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission. Such factors could materially adversely affect the Company's financial performance and could cause the Company's actual results for future periods to differ materially from any opinions or statements expressed within this press release.

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