Cardio Diagnostics Holdings, Inc. Receives Final Medicare Pricing Determination from Centers for Medicare and Medicaid Services (CMS) for AI-Powered Cardiovascular Tests

Rhea-AI Summary

Cardio Diagnostics Holdings (NASDAQ: CDIO) has received final pricing determinations from CMS for its AI-powered cardiovascular tests, PrecisionCHD and Epi+Gen CHD. The decision, effective for claims after January 1, 2025, allows Medicare contractors to determine pricing based on actual cost data, with preliminary gapfill pricing due by April 1, 2025.

Both tests received dedicated CPT PLA codes effective April 1, 2024: 0439U for Epi+Gen CHD and 0440U for PrecisionCHD. PrecisionCHD aids in CHD diagnosis through genetic and epigenetic markers, while Epi+Gen CHD assesses three-year risk for CHD events using an AI-driven integrated genetic-epigenetic approach.

Positive

• Received final CMS pricing determination for both cardiovascular tests
• Medicare reimbursement pathway established effective January 1, 2025
• Obtained dedicated CPT PLA codes for both tests (0439U and 0440U)

Negative

• Actual pricing not yet determined, pending Medicare contractors' evaluation
• Implementation delayed until 2025

Insights

Healthcare Financial Analyst

The CMS pricing determination represents a significant milestone for Cardio Diagnostics, opening access to the lucrative $705 billion Medicare market. With 18.7% of Americans covered by Medicare, this development establishes a clear reimbursement pathway for both PrecisionCHD and Epi+Gen CHD tests. The gapfill pricing mechanism, effective January 2025, allows for cost-based reimbursement, potentially ensuring sustainable profit margins. Given the substantial addressable market of Medicare beneficiaries and the high prevalence of cardiovascular disease in this population, this could drive significant revenue growth for CDIO.

Medical Technology Analyst

The AI-driven diagnostic platform positions CDIO at the intersection of two rapidly growing markets: AI diagnostics and cardiovascular care. The platform's dual capability in both diagnostic (PrecisionCHD) and predictive (Epi+Gen CHD) testing creates a comprehensive solution for CHD management. The genetic-epigenetic approach represents a technological advancement over traditional diagnostic methods, potentially offering superior accuracy and personalization. With dedicated CPT PLA codes (0439U and 0440U) now in place alongside Medicare coverage, the commercial infrastructure for widespread adoption is solidifying.

Market Research Analyst

With cardiovascular disease causing over 702,880 deaths in 2022 and CHD accounting for 371,506 of these, the market opportunity is substantial. The Medicare population's high cardiovascular disease burden makes this demographic particularly valuable. The timing of this CMS determination, coupled with the April 2024 CPT code implementation, suggests potential revenue recognition beginning in early 2025. For a company with a market cap of just $53.8 million, successful penetration of the Medicare market could significantly impact valuation multiples.

CMS pricing determination marks a key milestone in gaining broad access to Medicare reimbursement.

CHICAGO--(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/.

Forward-Looking Statements

Certain statements and information included in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, the words or phrases “will”, “will likely result,” “expected to,” “will continue,” “anticipated,” “estimate,” “projected,” “intend,” “goal,” or similar expressions are intended to identify “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of the Company. Such uncertainties and risks include but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, dependence on management, dilution to stockholders, lack of capital, the effects of rapid growth upon the Company and the ability of management to effectively respond to the growth and demand for products and services of the Company, newly developing technologies, the Company's ability to compete, regulatory matters, protection of technology, the effects of competition and the ability of the Company to obtain future financing. An extensive list of factors that can affect future results are discussed in the Current Report on Form 10-K for the period ended December 31, 2023, and Form 10-Q for the periods ended March 31, 2024, June 30, 2024 and September 30, 2024, under the heading “Risk Factors” in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission. Such factors could materially adversely affect the Company’s financial performance and could cause the Company’s actual results for future periods to differ materially from any opinions or statements expressed within this press release.

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Investors:

Investor Relations

855-226-9991

investors@cardiodiagnosticsinc.com

Media & Public Relations:

Kristen Hoff

855-226-9991

pr@cardiodiagnosticsinc.com

Source: Cardio Diagnostics Holdings, Inc.

FAQ

When will CDIO's Medicare pricing determination become effective?

The CMS pricing determination for CDIO's cardiovascular tests will become effective for claims with dates of service on or after January 1, 2025.

What are the CPT codes for CDIO's PrecisionCHD and Epi+Gen CHD tests?

PrecisionCHD received CPT code 0440U and Epi+Gen CHD received CPT code 0439U, both effective April 1, 2024.

When will Medicare contractors report preliminary gapfill pricing for CDIO's tests?

Medicare contractors will report preliminary gapfill pricing for calendar year 2025 by April 1, 2025.

What do CDIO's PrecisionCHD and Epi+Gen CHD tests measure?

PrecisionCHD aids in diagnosing coronary heart disease through genetic and epigenetic markers, while Epi+Gen CHD assesses three-year risk for CHD events using AI-driven genetic-epigenetic analysis.