Cardio Diagnostics Awaits CMS Decision on Medicare Payment for AI-Powered Heart Disease Tests
TL;DR
Cardio Diagnostics is awaiting a crucial decision that could be a major factor in the commercial success of its flagship heart disease tests.
The company attended a meeting hosted by the Centers for Medicare and Medicaid Services (CMS) to present pricing recommendations for its two cutting-edge tests: Epi+Gen CHD and PrecisionCHD.
Cardio Diagnostics' advanced diagnostic tools have the potential to bring its heart disease tests one step closer to being widely accessible to Medicare patients, potentially saving the lives of millions.
Cardio Diagnostics' AI-powered blood-based DNA test, Epi+Gen CHD, evaluates genetic and epigenetic markers to assess the three-year risk for a symptomatic CHD event.
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Cardio Diagnostics (NASDAQ: CDIO), a company leveraging artificial intelligence and precision epigenetics for cardiovascular disease prevention, is awaiting a crucial decision from the Centers for Medicare and Medicaid Services (CMS) that could determine the commercial success of its flagship heart disease tests. The company attended the CMS annual meeting in June, where it submitted pricing recommendations and supporting information for its two cutting-edge tests: Epi+Gen CHD and PrecisionCHD.
The CMS is expected to release its proposed payment determinations in September, based on the timeline posted by the CMS on its website at https://www.cms.gov/. These preliminary determinations will incorporate information from the annual meeting, public comments, and recommendations from the Clinical Diagnostic Laboratory Tests Advisory Panel, with final determinations anticipated in November. This decision represents a critical milestone for making advanced cardiovascular diagnostics accessible to Medicare beneficiaries.
Heart disease remains the leading cause of death among Medicare beneficiaries, with coronary heart disease (CHD) being the most common type and primary cause of heart attacks, responsible for 371,506 deaths in the U.S. in 2022. Cardio Diagnostics has developed state-of-the-art solutions to address this urgent need, including Epi+Gen CHD, an AI-powered blood-based DNA test that evaluates genetic and epigenetic markers to assess three-year risk for symptomatic CHD events, and PrecisionCHD, which aids in diagnosing the condition.
Both tests have already received unique CPT codes from the American Medical Association (0439U and 0440U, respectively), which became effective in April 2024. The company's Actionable Clinical Intelligence provider-facing platform complements these tests by providing personalized insights that link epigenetic and genetic biomarkers to the drivers of coronary heart disease. The CMS decision could bring these innovative tests one step closer to widespread accessibility for Medicare patients, potentially impacting millions of lives through improved prevention and early detection of cardiovascular disease.
Curated from News Direct

