Potential Catalyst Right Around The Corner? CMS To Announce Preliminary Medicare Payment For Cardio Diagnostics' Heart Disease Tests

Cardio Diagnostics CDIO, the company leveraging AI to revolutionize cardiovascular disease prevention with precision epigenetics, is awaiting a crucial decision that could be a major factor in the commercial success of its flagship heart disease tests.

In June of this year, the company attended an annual meeting hosted by the Centers for Medicare and Medicaid Services (CMS), where healthcare companies presented the prices they think Medicare should pay for their products and the rationale for their recommendation. At this meeting, Cardio Diagnostics submitted information and pricing recommendations for its two cutting-edge tests: Epi+Gen CHD and PrecisionCHD.

Now, the company is awaiting the next important step – the CMS is expected to release its proposed payment determinations in September, based on the timeline posted by the CMS on its website. These preliminary determinations are based on the information from said annual meeting, public comments and the recommendations from the Clinical Diagnostic Laboratory Tests (CDLT) Advisory Panel. The final determinations are expected in November. 

“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,” stated Meesha Dogan, PhD, CEO and Co-Founder of Cardio Diagnostics.

A Trilogy Of AI-Powered Solutions For Heart Disease

According to the CMS, heart disease is the leading cause of death among Medicare beneficiaries. Coronary heart disease (CHD) is the most common type of heart disease and the primary cause of heart attacks, killing 371,506 people in the U.S. in 2022.

Recognizing the urgent need for advanced diagnostic tools, Cardio Diagnostics has developed state-of-the-art solutions to assess risk for, detect, manage and monitor CHD.

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 CHD event, while PrecisionCHD aids in diagnosing the condition. Both tests have already been assigned unique CPT codes by the American Medical Association, 0439U and 0440U, respectively, which became effective in April 2024.

Coupled with the Epi+Gen CHD and PrecisionCHD tests is the Actionable Clinical Intelligence (ACI) provider-facing platform, which provides personalized insights by linking the epigenetic and genetic biomarkers evaluated by these tests to the drivers of coronary heart disease.

With the crucial decision from the CMS expected this month, Cardio Diagnostics is on the brink of a breakthrough that has the potential to bring its heart disease tests one step closer to being widely accessible to Medicare patients, potentially saving the lives of millions.

Click here to find out more about Cardio Diagnostics.

Featured photo by Jean-Louis Paulin on Unsplash.

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