Medicare sets preliminary payment rates for Cardio Diagnostics tests

CHICAGO - The Centers for Medicare and Medicaid Services (CMS) has issued preliminary gapfill payment rates for two cardiovascular tests developed by Cardio Diagnostics Holdings, Inc. (NASDAQ:CDIO), a micro-cap diagnostics company with a market value of $7.6 million, the company announced Tuesday. According to InvestingPro analysis, CDIO is currently trading below its Fair Value, suggesting potential upside for investors interested in the diagnostic testing sector.

CMS, through its MolDX program, has proposed payment rates of $350 for Epi+Gen CHD and $684.76 for PrecisionCHD. These rates are part of the calendar year 2025 gapfill pricing process and are expected to be finalized later this year, becoming effective for claims with dates of service beginning January 1, 2025. This development comes as the company approaches its next earnings announcement, scheduled for August 14, 2025, which InvestingPro subscribers can track along with real-time financial metrics and expert analysis.

The company noted that initial public documentation had incorrectly transposed the pricing between the two tests, which has since been clarified with MolDX.

Epi+Gen CHD provides assessment of a patient’s three-year risk for coronary heart disease events, while PrecisionCHD is designed to aid in CHD diagnosis by analyzing genetic and epigenetic markers. Both tests received dedicated CPT Proprietary Laboratory Analysis codes from the American Medical Association that became effective April 1, 2024.

"We view this as a critical step toward expanding timely access and improving care for Medicare patients," said Meesha Dogan, CEO and Co-Founder of Cardio Diagnostics.

Cardiovascular disease remains the leading cause of death in the United States, with over 700,000 Americans dying from heart disease in 2022. Coronary heart disease specifically accounted for more than 370,000 of those deaths.

The payment rates determination is based on cost data provided by Cardio Diagnostics to Medicare contractors, according to the company’s press release statement.

In other recent news, Cardio Diagnostics Holdings Inc. has made several notable announcements. The company has entered into a clinical study agreement with AGEPHA Pharma to investigate a treatment for inflammation-driven coronary heart disease. This study will use AGEPHA’s FDA-approved medication, LODOCO, and Cardio’s PrecisionCHD blood test to identify suitable patients. Additionally, Cardio Diagnostics has secured a patent in Japan for heart disease biomarkers, expanding its international intellectual property portfolio. This patent is exclusively licensed from the University of Iowa Research Foundation and complements existing patents in the United States, Europe, Australia, India, and China.

In another development, Cardio Diagnostics announced a 1-for-30 reverse stock split of its common stock. This action is aimed at meeting Nasdaq’s minimum bid price requirement for continued listing. The reverse stock split is scheduled to take effect on May 13, 2025. Despite the split, the company’s ticker symbol will remain unchanged. These recent developments highlight Cardio Diagnostics’ strategic efforts in research, intellectual property, and compliance with market regulations.

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