Cardio Diagnostics Holdings, an AI-driven precision cardiovascular medicine company, announced its upcoming participation in the Clinical Laboratory Fee Schedule (CLFS) Annual Meeting on June 25, 2024.

Hosted by the Centers for Medicare & Medicaid Services (CMS), this meeting will consider pricing recommendations for Cardio Diagnostics’ clinical tests for Medicare payment under the CLFS for the 2025 calendar year.

At the CLFS Annual Meeting, Cardio Diagnostics will present data to support the establishment of payment amounts for its Epi+Gen CHD and PrecisionCHD tests. Following the meeting, CMS plans to release proposed payment determinations by early September 2024. These will include the rationale behind each recommendation and a request for public comments.

Final payment determinations, along with their supporting rationales, are expected to be posted on the CMS website in November 2024. These decisions will be key in setting the CLFS payment rates for 2025 for the Epi+Gen CHD and PrecisionCHD tests.

Both tests were recently assigned dedicated CPT Proprietary Laboratory Analyses (PLA) codes by the American Medical Association (AMA), with codes 0439U for Epi+Gen CHD and 0440U for PrecisionCHD, effective April 1, 2024.

"Participating in the CLFS Annual Meeting is crucial for securing Medicare payment for our innovative tests," stated CEO and Co-Founder of Cardio Diagnostics. "Our advanced tests represent a significant step forward in the prevention, detection, and management of coronary heart disease, and we are committed to making them accessible to Medicare beneficiaries."

Cardio Diagnostics is also seeking coverage through the Molecular Diagnostic Services (MolDx) program and has a pre-submission meeting scheduled for Q3 2024 to discuss coverage options for Epi+Gen CHD and PrecisionCHD.

The company will showcase its flagship tests: Epi+Gen CHD, 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; and PrecisionCHD, an AI-powered blood-based DNA test that uses genetic and epigenetic markers to aid in diagnosing CHD.

Both tests offer personalized, actionable insights that can significantly influence clinical decisions, improving the detection, prevention, and management of CHD, and ultimately reducing healthcare costs and improving patient outcomes.

CMS data indicates that heart disease is the leading cause of death among Medicare beneficiaries, with about 82% of CHD-related deaths occurring in those aged 65 and older.

The average age for a first heart attack is 65.6 years for men and 72.0 years for women. The rising incidence of CHD among Medicare patients highlights the need for advanced diagnostic tools like Epi+Gen CHD and PrecisionCHD.

 

 

 

Source: businesswire.com

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