Cardio Diagnostics to Participate in the Centers for Medicare and Medicaid Services’ (CMS) Clinical Laboratory Fee Schedule (CLFS) Annual Meeting to Secure Medicare Payment for Its Innovative Tests

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