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Cardio Diagnostics Receives Gapfill Payment Rates for AI-Driven Cardiovascular Tests from the Centers for Medicare and Medicaid Services (CMS)

By: via Business Wire

Obtaining the payment rates marks a key milestone in gaining broad access to Medicare reimbursement.

Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-powered precision cardiovascular medicine company, today announced that the Centers for Medicare and Medicaid Services (CMS), through the MolDX program, has issued preliminary gapfill payment rates of $350 for Epi+Gen CHD™ and $684.76 for PrecisionCHD™. A ‘gapfill’ payment rate means that pricing is determined by each Medicare contractor, including MolDX, based on cost data from Cardio Diagnostics.

These preliminary payment rates, proposed as part of the calendar year 2025 gapfill pricing process, are expected to be finalized later this year and will be effective for claims with dates of service on or after January 1, 2025. The proposed rates represent a significant positive development in the Company’s efforts to expand access to its advanced cardiovascular testing for Medicare beneficiaries.

“We view this as a critical step toward expanding timely access and improving care for Medicare patients” said Meesha Dogan, PhD., CEO and Co-Founder of Cardio Diagnostics. “Many Medicare beneficiaries, who are at elevated risk for coronary heart disease, go undetected and undertreated, often resulting in avoidable heart attacks, hospitalizations, and poor outcomes.”

Cardio Diagnostics clarified during a recent meeting with MolDX that initial public documentation had inadvertently transposed the pricing between the two tests, and MolDX confirmed the correct association of the proposed payment rates to their respective tests.

Addressing the Leading Cause of Death

Cardiovascular disease remains the leading cause of death in the United States, particularly among Americans aged 65 and older. In 2022 alone, over 700,000 Americans died from heart disease, with coronary heart disease (CHD) accounting for more than 370,000 deaths.

PrecisionCHD™ is a groundbreaking AI-powered test designed to aid in the diagnosis of CHD by analyzing both genetic and epigenetic markers. Meanwhile, Epi+Gen CHD™ provides insight into a patient’s three-year risk for a CHD event, such as a heart attack. Both tests are performed from a simple blood draw, enabling scalable, accessible, and non-invasive cardiovascular assessment. Both tests received dedicated CPT Proprietary Laboratory Analysis (PLA) codes from the American Medical Association, 0439U for Epi+Gen CHD and 0440U for PrecisionCHD, that were effective on April 1, 2024.

About Cardio Diagnostics

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 https://cdio.ai/.

Forward-Looking Statements

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, and dependence on results as discussed in the Annual Report on Form 10-K for the period ended December 31, 2024, 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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