Cardio Diagnostics Holdings, a company specialising in AI-powered precision cardiovascular medicine, has announced that its PrecisionCHD and Epi+Gen CHD tests have received final pricing approval from the Centres for Medicare & Medicaid Services (CMS).

Following a preliminary pricing decision in August 2024, CMS has confirmed the ‘gapfill’ pricing process for both tests. This decision will take effect for claims dated from 1 January 2025, allowing Medicare contractors to establish pricing based on cost data provided by Cardio Diagnostics. Preliminary gapfill pricing for the 2025 calendar year is expected to be reported to CMS by 1 April 2025.

This development represents an important step towards improving the identification, management, and monitoring of coronary heart disease (CHD) in Medicare patients. By enabling clinicians to personalise treatment more effectively, the tests aim to address unmet needs in cardiovascular care and improve outcomes for patients.

Cardiovascular disease remains the leading cause of death in the United States, particularly among those aged 65 and older. In 2022, heart disease accounted for 702,880 deaths, with a mortality rate of 211 deaths per 100,000 people. Coronary heart disease, the most prevalent type, was responsible for 371,506 of these deaths.

PrecisionCHD, an AI-driven blood test, assists in diagnosing coronary heart disease by analysing genetic and epigenetic markers. Epi+Gen CHD evaluates the likelihood of a coronary heart disease event, such as a heart attack, within three years, using a similar integrated genetic and epigenetic approach.

Both tests have been assigned specific Proprietary Laboratory Analysis (PLA) codes, 0439U for Epi+Gen CHD and 0440U for PrecisionCHD, which became effective from 1 April 2024.



Source: cdio.ai

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