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CMS pricing determination marks a key milestone in gaining broad access to Medicare reimbursement.
CHICAGO, December 16, 2024--(BUSINESS WIRE)--Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-driven precision cardiovascular medicine company today announced that the Company’s PrecisionCHD and Epi+Gen CHD tests have received final pricing determinations from the Centers for Medicare & Medicaid Services (CMS). Following the preliminary pricing determination made by CMS in August 2024, CMS finalized the ‘gapfill’ pricing determination for both PrecisionCHD and Epi+Gen CHD. This decision will be effective for claims with dates of service on or after January 1, 2025, and will allow Medicare contractors to determine pricing for PrecisionCHD and Epi+Gen CHD based on actual cost data from Cardio Diagnostics. The Medicare contractors will report to CMS preliminary gapfill pricing for calendar year 2025 by April 1, 2025.
"Receiving this final determination is a crucial step for our innovative solutions to help improve the risk assessment, diagnosis, management and monitoring of coronary heart disease (CHD) for Medicare patients," said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics. "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."
Cardiovascular disease is the leading cause of death in the United States, including among Americans over 65 years old. In 2022, the number of deaths due to heart disease was 702,880, with a mortality rate of 211 deaths per 100,000 population. Coronary heart disease, the most common type of heart disease, claimed 371,506 lives. PrecisionCHD is an AI-powered blood test that aids in the diagnosis of coronary heart disease (CHD) by evaluating genetic and epigenetic markers. Epi+Gen CHD assesses the three-year risk for a CHD event, including heart attacks, using a similar AI-driven integrated genetic-epigenetic approach. Both tests received dedicated CPT Proprietary Laboratory Analysis (PLA) codes from the American Medical Association, 0439U for Epi+Gen CHD and 0440U for PrecisionCHD, that were effective on April 1, 2024.
About Cardio Diagnostics
Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine ("Core Technology") for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. For more information, please visit http://www.cdio.ai/.