Cardio Diagnostics Secures Key Medicare Rate for AI Heart Tests
CMS finalizes an $854 payment rate for the company's novel cardiovascular diagnostics, a critical step toward commercialization and wider market access.
Cardio Diagnostics (Nasdaq: CDIO), a biotechnology company developing artificial intelligence-driven cardiovascular tests, has secured a final reimbursement rate from the Centers for Medicare & Medicaid Services (CMS), a pivotal step that validates its technology and clears a path to revenue.
CMS established a final gapfill payment rate of $854 for the company’s flagship products, the Epi+Gen CHD™ and PrecisionCHD™ tests, according to a company announcement. This decision provides a crucial pricing structure for the company’s services under Medicare, one of the largest healthcare payers in the United States, significantly de-risking its commercialization strategy.
Shares of the micro-cap firm saw a modest initial rise of 2.3% to $2.89 in the wake of the news. For a company with a market capitalization of just over $5 million, securing a defined and favorable CMS rate is a foundational event that can pave the way for broader clinical adoption.
“This final payment rate of $854 for Epi+Gen CHD™ and PrecisionCHD™ is a monumental achievement that validates the clinical value and economic benefit of our AI-driven tests in preventing cardiovascular disease,” said Meeshantha Kulasuriya, CEO and Co-Founder of Cardio Diagnostics. “It provides a clear reimbursement pathway, expanding access for Medicare beneficiaries to our innovative solutions.”
The two tests are designed to be less invasive and more precise tools for assessing the risk of coronary heart disease. By using AI to analyze a combination of genetic and epigenetic biomarkers from a blood sample, the tests aim to help clinicians identify at-risk patients and personalize preventive care long before a major cardiac event occurs.
The CMS "gapfill" process is used to determine payment for new or advanced diagnostic laboratory tests that are not yet on the Clinical Laboratory Fee Schedule. The comprehensive review by Medicare Administrative Contractors (MACs) analyzes a test's clinical utility and economic value, making the final rate a strong endorsement of the technology's potential.
Securing a permanent reimbursement code and a favorable rate is one of the most significant hurdles for diagnostic test makers. Without it, companies face an uphill battle in convincing doctors to order the tests and in generating meaningful revenue. With the CMS rate now established, Cardio Diagnostics has a clear value proposition for healthcare providers who treat the millions of Americans covered by Medicare.
The company’s stock has been highly volatile over the past year, trading in a wide range between $2.42 and $53.10. While the initial market reaction was subdued, the CMS decision provides a fundamental catalyst that could support a re-evaluation of the company's long-term prospects. The focus for Cardio Diagnostics will now shift from regulatory validation to commercial execution as it works to integrate its tests into clinical practice across the country.