Cardio Diagnostics Holdings Inc. CDIO, an AI-powered precision cardiovascular medicine company, is making progress in gaining broad access to Medicare reimbursement for its Epi+Gen CHD™ and PrecisionCHD™ tests, which can provide insight into heart attack risk and aid in the diagnosis of coronary heart disease (CHD), respectively.
Through the MolDX program, which identifies, assesses and establishes coverage and reimbursements for diagnostic and laboratory-developed tests, CMS has issued preliminary gapfill payment rates of $350 for Epi+Gen CHD and $684.76 for PrecisionCHD.
It's a major milestone for Cardio Diagnostics, with the final rates slated to be released later this year for claims with dates of service on or after January 1, 2025, reports the company. The company also noted that during a recent meeting with MolDX, the initial public documentation had inadvertently transposed the pricing between the two tests, and MolDX confirmed the correct association of the proposed payment rates to their respective tests.
"We view this as a critical step toward expanding timely access and improving care for Medicare patients," said Meesha Dogan, PhD., CEO and co-founder of Cardio Diagnostics. "Many Medicare beneficiaries, who are at elevated risk for coronary heart disease, go undetected and undertreated, often resulting in avoidable heart attacks, hospitalizations and poor outcomes."
Gapfill payment rates for Medicare occur when there are no comparable existing codes. The Medicare Administrative Contractors such as MolDX help determine the local payment amounts based on various factors, including cost data from Cardio Diagnostics.
Receiving gapfill payment rates is one step closer for Cardio Diagnostics in receiving broad Medicare reimbursement for their tests that provide insight into a patient's three-year risk of a CHD event, including a heart attack, and help to diagnose CHD, which accounted for over 370,000 deaths in America in 2022. Cardiovascular disease remains the leading cause of death in the United States, particularly among Americans aged 65 and older.
AI-Driven Tests
Cardio Diagnostics' PrecisionCHD test is an AI-powered integrated genetic-epigenetic test to aid in the diagnosis and management of CHD. The six DNA methylation markers evaluated by the PrecisionCHD test map to modifiable drivers of CHD, including inflammation. For each patient, the PrecisionCHD test provides personalized insights into their specific molecular drivers that could help inform more targeted treatment and clinical decision making, reports the company.
Recently, Cardio Diagnostics partnered with AGEPHA Pharma for a clinical study to explore the use of Cardio Diagnostics' PrecisionCHD™ blood test with AGEPHA's FDA-approved anti-inflammatory medication LODOCO® (low-dose colchicine) to assess their response over time.
Meanwhile, Cardio Diagnostics' Epi+Gen CHD test is designed to assess a person's three-year risk of a CHD event, including a heart attack. The test relies on a combination of epigenetics and AI to provide a more sensitive and cost-effective way to assess risk than traditional tools including the Framingham Risk Score (FRS) and ASCVD Risk Calculator, reports Cardio Diagnostics. Both tests are performed from a simple blood draw, enabling scalable, accessible and non-invasive cardiovascular assessment, reports the company.
Heart disease is a big and growing problem. According to the American Heart Association, by 2050, about six in 10 U.S. adults will have some type of heart disease. That amounts to over 184 million adults in the U.S. alone. Cardio Diagnostics is playing a role in potentially curbing those statistics.
Feature image from Shutterstock.
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