Cardio Diagnostics Secures Medicare Reimbursement for Heart Disease Tests

Cardio Diagnostics Holdings Inc. has achieved a significant milestone by gaining preliminary Medicare reimbursement rates for its innovative heart disease tests, the Epi+Gen CHD and PrecisionCHD. These tests aim to enhance the diagnosis of coronary heart disease (CHD) and assess heart attack risk in patients. The Centers for Medicare & Medicaid Services (CMS), through its MolDX program, has proposed gapfill payment rates of $350 for the Epi+Gen CHD test and $684.76 for the PrecisionCHD test, which are set to be finalized later this year for claims dated on or after January 1, 2025.

The gapfill payment rates are particularly noteworthy as they signal a pathway for Cardio Diagnostics to broaden access to its tests, which are critical for detecting CHD—a condition that was responsible for over 370,000 deaths in the United States in 2022. The company emphasized the importance of these tests in identifying patients at elevated risk for heart disease, which often goes unnoticed and untreated, leading to preventable heart attacks and adverse health outcomes.

Meesha Dogan, PhD, CEO and co-founder of Cardio Diagnostics, remarked, “We view this as a critical step toward expanding timely access and improving care for Medicare patients.” The company also clarified that during a recent meeting with MolDX, there was an initial error in public documentation regarding the pricing association of the two tests. MolDX has since confirmed the correct payment rate assignments.

Innovative Testing Solutions for Heart Disease

The PrecisionCHD test stands out as an AI-integrated genetic-epigenetic tool designed to aid in the management of CHD. It evaluates six DNA methylation markers that correlate with modifiable risk factors, including inflammation. This personalized approach allows healthcare providers to make more informed treatment decisions based on a patient’s unique molecular profile.

In an effort to further enhance its offerings, Cardio Diagnostics has partnered with AGEPHA Pharma to conduct a clinical study. This research will investigate the effectiveness of the PrecisionCHD blood test in conjunction with AGEPHA’s FDA-approved anti-inflammatory medication, LODOCO (low-dose colchicine), over a specified duration.

In addition, the Epi+Gen CHD test assesses a patient’s three-year risk of CHD events, including heart attacks. This test employs a combination of epigenetic data and AI technology, providing a more sensitive and cost-effective risk evaluation compared to traditional methods such as the Framingham Risk Score and the ASCVD Risk Calculator. Both tests require only a simple blood draw, making them non-invasive and accessible for widespread cardiovascular assessment.

The Growing Challenge of Heart Disease

Heart disease continues to pose a significant health challenge in the United States. According to the American Heart Association, it is projected that by 2050, approximately six in ten U.S. adults will have some form of heart disease, equating to more than 184 million individuals. The efforts by Cardio Diagnostics in developing these advanced tests are pivotal in addressing this growing public health crisis, potentially leading to better patient outcomes and reduced healthcare costs associated with cardiovascular diseases.

As the landscape of healthcare continues to evolve, the introduction of AI-driven diagnostic tools like those from Cardio Diagnostics could play a crucial role in improving early detection and treatment of heart conditions, ultimately fostering a healthier future for Medicare beneficiaries.