Cardio Diagnostics Secures Medicare Reimbursement for Heart Disease Tests

Cardio Diagnostics Holdings Inc. has achieved a significant milestone by securing preliminary Medicare reimbursement rates for its innovative cardiovascular tests. The company’s Epi+Gen CHD and PrecisionCHD tests, designed to assess heart attack risk and aid in diagnosing coronary heart disease (CHD), will now receive reimbursement through the Centers for Medicare & Medicaid Services (CMS) under the MolDX program.

The preliminary gapfill payment rates issued by CMS are set at $350 for the Epi+Gen CHD test and $684.76 for the PrecisionCHD test. These rates will apply to claims with service dates on or after January 1, 2025. This development represents a crucial step toward expanding access to essential cardiovascular diagnostics for Medicare beneficiaries.

Improving Patient Outcomes

During a recent meeting with MolDX, Cardio Diagnostics clarified an earlier error in public documentation that had misassigned the proposed payment rates to the incorrect tests. Dr. Meesha Dogan, CEO and co-founder of Cardio Diagnostics, emphasized the importance of these tests, stating, “We view this as a critical step toward expanding timely access and improving care for Medicare patients.”

The tests target a population that often goes undiagnosed and untreated, leading to preventable heart attacks and hospitalizations. CHD is a major health concern in the United States, contributing to over 370,000 deaths in 2022, with cardiovascular disease remaining the leading cause of death, particularly among those aged 65 and older.

Innovative Technology in Cardiology

Cardio Diagnostics’ PrecisionCHD test utilizes an AI-powered integrated genetic-epigenetic approach to support the diagnosis and management of CHD. It evaluates six DNA methylation markers that correspond to modifiable risk factors, such as inflammation. By providing personalized insights, the test aims to guide more targeted treatment strategies for patients.

The company has also partnered with AGEPHA Pharma to conduct a clinical study, exploring the efficacy of the PrecisionCHD blood test in conjunction with AGEPHA’s FDA-approved anti-inflammatory medication, LODOCO® (low-dose colchicine).

The Epi+Gen CHD test assesses an individual’s three-year risk of experiencing a CHD event, including heart attacks. This test combines epigenetics and AI to offer a more sensitive and cost-effective risk assessment compared to traditional methods like the Framingham Risk Score and the ASCVD Risk Calculator. Both tests are performed via a simple blood draw, making cardiovascular assessment more accessible and non-invasive.

As heart disease continues to escalate, the American Heart Association projects that by 2050, approximately six in ten adults in the United States will be affected by some form of heart disease, amounting to over 184 million individuals. Cardio Diagnostics is positioning itself as a key player in addressing this looming public health crisis through its advanced testing solutions.