NEW YORK – Cardio Diagnostics announced Monday that it has received final pricing determinations for two of its assays from the US Centers for Medicare and Medicaid Services.
Both the PrecisionCHD and Epi+Gen CHD assays have received gapfill determinations, meaning Medicare contractors will determine pricing for the two tests based on cost data from Cardio Diagnostics. The decision will be effective for claims with dates of service on or after Jan. 1, 2025, and Medicare contractors will report preliminary gapfill pricing to CMS by April 1, 2025, the Chicago-based company said in a statement.
The gapfill process is used when no comparable test exists and allows Medicare contractors to develop a local payment amount for a new test code. CMS then calculates the median rate for the test code across all contractors to decide the final price.
PrecisionCHD uses artificial intelligence to diagnose coronary heart disease (CHD) by evaluating genetic and epigenetic markers, while Epi+Gen CHD determines the three-year risk for a CHD event, such as a heart attack, using a similar AI-based genetic and epigenetic technique.
"Receiving this final determination is a crucial step for our innovative solutions to help improve the risk assessment, diagnosis, management, and monitoring of CHD for Medicare patients," Cardio Diagnostics CEO and Cofounder Meesha Dogan said in a statement. "This milestone brings us closer to addressing the significant unmet needs in cardiovascular care for the Medicare population, enabling clinicians to better personalize treatment strategies and ultimately improve patient outcomes."