Summary: Cardio Diagnostics Holdings announced that the CMS finalized gapfill pricing determinations for its AI-powered cardiovascular disease tests.
Takeaways:
- CMS Pricing Finalization: The finalized gapfill pricing allows Medicare contractors to set rates based on Cardio Diagnostics’ cost data, effective for claims starting January 1, 2025.
- Innovative CHD Diagnostics: PrecisionCHD and Epi+Gen CHD utilize AI-driven genetic and epigenetic markers to diagnose and assess coronary heart disease (CHD) risk, addressing critical cardiovascular care needs.
- Impact on Medicare Population: This milestone supports personalized treatment strategies for Medicare patients, improving outcomes in managing the leading cause of death in the U.S.
Cardio Diagnostics Holdings, an AI-driven precision cardiovascular medicine company 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.
Pricing Determinations for 2025
This decision will be effective for claims with dates of service on or after Jan. 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,” says Meesha Dogan, PhD, 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.”
Diagnosing Cardiovascular Disease
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.