Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-driven precision cardiovascular medicine company, today announced its participation in the Clinical Laboratory Fee Schedule (CLFS) Annual Meeting on June 25, 2024. At this meeting hosted by the Centers for Medicare & Medicaid Services (CMS), the Company will recommend pricing for its innovative clinical tests to be considered for Medicare payment under the CLFS for calendar year 2025.
At the CLFS Annual Meeting, Cardio Diagnostics will submit information and recommendations to support the establishment of payment amounts for its Epi+Gen CHD and PrecisionCHD tests. Taking into account the feedback received during the meeting, CMS is expected to share proposed determinations by early September 2024. This will include the basis for each payment amount recommendation and a request for public comments.
Final determinations, including the rationale supporting each decision, is expected to be posted on the CMS website in November 2024. These determinations will be crucial in setting the payment rates under the CLFS for calendar year 2025 for the Company’s Epi+Gen CHD and PrecisionCHD that were recently awarded dedicated CPT Proprietary Laboratory Analyses (PLA) codes by the American Medical Association (AMA). The codes are 0439U for Epi+Gen CHD and 0440U for PrecisionCHD, and went effective April 1, 2024.
“Participating in the CLFS Annual Meeting is a critical step towards securing Medicare payment for our innovative tests,” stated Meesha Dogan, PhD, CEO and Co-Founder of Cardio Diagnostics. “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.”
In addition to engaging with the CLFS process, Cardio Diagnostics is actively pursuing coverage through the Molecular Diagnostic Services (MolDx) program. A pre-submission meeting with MolDx is scheduled for Q3 2024 to further discuss coverage options for Epi+Gen CHD and PrecisionCHD.
Cardio Diagnostics will present information for its two flagship tests: Epi+Gen CHD and PrecisionCHD. 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 coronary heart disease (CHD) event, including heart attacks. PrecisionCHD is an AI-powered blood-based DNA test that evaluates genetic and epigenetic markers to aid in diagnosing CHD. Both tests
According to the CMS, heart disease remains the leading cause of death among Medicare beneficiaries, with about 82% of deaths from CHD occurring in those 65 years or older. The average age for a first heart attack for men and women is 65.6 years and 72.0 years, respectively. The growing incidence of CHD among Medicare patients highlights the urgent need for advanced diagnostic tools like Epi+Gen CHD and PrecisionCHD. These Precision Medicine tests offer timely, personalized and actionable insights, impacting clinical decision-making of interventions to enable better detection, prevention and management of CHD, ultimately reducing morbidity, mortality and healthcare costs.
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 www.cardiodiagnosticsinc.com.
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, dependence on results are discussed in the Current Report on Form 10-K for the period ended December 31, 2023, and Form 10-Q for the period ended March 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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