Cardio Diagnostics Set to Join CMS CLFS Annual Meeting, Pursuing Medicare Payment Approval for Novel Tests

Wednesday, May 22, 2024

Cardio Diagnostics Holdings, has announced its involvement in the Clinical Laboratory Fee Schedule (CLFS) Annual Meeting set for June 25, 2024. Hosted by the Centers for Medicare & Medicaid Services (CMS), this event is crucial for the company as it seeks pricing recommendations for its clinical tests to be eligible for Medicare reimbursement under the CLFS for the 2025 calendar year.

During the meeting, Cardio Diagnostics will present information and recommendations supporting payment rates for its Epi+Gen CHD and PrecisionCHD tests. CMS is expected to release proposed determinations by early September 2024, followed by final determinations in November 2024.

These determinations will directly impact payment rates under the CLFS for the company's tests, which recently received dedicated CPT Proprietary Laboratory Analyses (PLA) codes from the American Medical Association (AMA).

CEO and Co-Founder of Cardio Diagnostics, emphasized the importance of participating in the CLFS Annual Meeting, stating it's a critical step toward securing Medicare reimbursement for their tests.

Highlighted the significance of these tests in advancing the prevention, detection, and management of coronary heart disease (CHD), underscoring the company's commitment to accessibility for Medicare beneficiaries.

In addition to engagement with the CLFS process, Cardio Diagnostics is pursuing coverage through the Molecular Diagnostic Services (MolDx) program. A pre-submission meeting with MolDx is scheduled for the third quarter of 2024 to explore coverage options further for Epi+Gen CHD and PrecisionCHD.

Cardio Diagnostics will showcase information on its 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 symptomatic coronary heart disease (CHD) events, including heart attacks.

PrecisionCHD, likewise powered by AI, analyzes genetic and epigenetic markers to aid in CHD diagnosis.

Heart disease remains the leading cause of death among Medicare beneficiaries, with approximately 82% of CHD-related deaths occurring in individuals aged 65 or older, according to CMS data. The growing incidence of CHD among Medicare patients underscores the urgent need for advanced diagnostic tools such as Epi+Gen CHD and PrecisionCHD.

These precision medicine tests offer timely, personalized, and actionable insights, influencing clinical decision-making for interventions aimed at better detection, prevention, and management of CHD, ultimately leading to reduced morbidity, mortality, and healthcare costs.



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