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

Rhea-AI Summary

Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO) has received preliminary pricing determinations from the Centers for Medicare & Medicaid Services (CMS) for its PrecisionCHD and Epi+Gen CHD tests. This marks a important step towards securing Medicare reimbursement for these AI-powered cardiovascular tests. The preliminary 'gapfill' pricing decision, if finalized, will be effective for claims starting January 1, 2025, allowing Medicare contractors to determine pricing based on actual cost data.

The tests aim to improve risk assessment, diagnosis, management, and monitoring of coronary heart disease (CHD) for Medicare patients. PrecisionCHD aids in CHD diagnosis using genetic and epigenetic markers, while Epi+Gen CHD assesses the three-year risk for a CHD event. Both tests received dedicated CPT Proprietary Laboratory Analysis (PLA) codes effective April 1, 2024.

Positive

• Preliminary CMS pricing determination received for PrecisionCHD and Epi+Gen CHD tests
• Step towards securing Medicare reimbursement, potentially expanding market access
• Dedicated CPT Proprietary Laboratory Analysis (PLA) codes assigned to both tests

Negative

• Final pricing and reimbursement not yet secured
• Potential delay in revenue generation as pricing effective from January 1, 2025

Insights

Healthcare Policy Analyst

The preliminary Medicare pricing determination for Cardio Diagnostics' PrecisionCHD and Epi+Gen CHD tests is a significant development in the cardiovascular diagnostics landscape. This 'gapfill' pricing approach allows for a more nuanced valuation of these innovative AI-driven tests, potentially setting a precedent for how novel diagnostic technologies are reimbursed.

Key implications include:

• Improved access for Medicare beneficiaries to advanced CHD risk assessment and diagnostic tools
• Potential for more personalized and cost-effective cardiovascular care
• A possible shift in the diagnostic paradigm for coronary heart disease

However, it's important to note that final pricing is still pending and the actual impact on Cardio Diagnostics' revenue stream won't be clear until after April 1, 2025. Investors should monitor how private insurers respond to this CMS decision, as it could influence broader market adoption.

Cardiovascular Research Specialist

The introduction of PrecisionCHD and Epi+Gen CHD tests represents a significant advancement in cardiovascular diagnostics. These AI-powered tests integrate genetic and epigenetic markers, offering a more comprehensive risk assessment and diagnostic capability for coronary heart disease (CHD).

The potential benefits are substantial:

• Enhanced early detection and risk stratification for CHD
• More targeted preventive interventions and personalized treatment plans
• Reduction in unnecessary invasive procedures and healthcare costs

With CHD being the leading cause of death in the U.S., especially among those over 65, these tests could significantly impact patient outcomes. The AI-driven approach also aligns with the broader trend towards precision medicine in cardiology. However, real-world performance data and comparative studies with existing risk assessment tools will be important to validate their clinical utility and cost-effectiveness.

Preliminary 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 preliminary pricing determinations from the Centers for Medicare & Medicaid Services (CMS). This determination represents a crucial step toward securing Medicare reimbursement, enabling access to the Company’s affordable, innovative, and highly scalable blood tests aimed at improving the risk assessment, diagnosis, management and monitoring of coronary heart disease (CHD) for Medicare patients.

CMS recently issued a preliminarily determination to price both PrecisionCHD and Epi+Gen CHD on a ‘gapfill’ basis. This decision, following the Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting held on June 25, 2024, recognizes the unique value of these tests. If finalized, 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.

“We are proud to reach this important milestone with CMS, bringing us closer to making our cutting-edge cardiovascular tests accessible to Medicare patients,” said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics. “This determination underscores the value of innovation in healthcare, and we’re excited to support clinicians with advanced tools that can enhance the diagnosis and management of coronary heart disease, ultimately improving outcomes for one of the most at-risk populations.”

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 and June 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241001680555/en/

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

What is the significance of CMS's preliminary pricing determination for Cardio Diagnostics (CDIO)?

CMS's preliminary pricing determination is a important step towards securing Medicare reimbursement for Cardio Diagnostics' PrecisionCHD and Epi+Gen CHD tests, potentially expanding access to these AI-powered cardiovascular tests for Medicare patients.

When will the CMS pricing for Cardio Diagnostics' (CDIO) tests be effective?

If finalized, the CMS pricing for Cardio Diagnostics' tests will be effective for claims with dates of service on or after January 1, 2025.

What are the CPT codes assigned to Cardio Diagnostics' (CDIO) PrecisionCHD and Epi+Gen CHD tests?

PrecisionCHD was assigned CPT code 0440U, and Epi+Gen CHD was assigned CPT code 0439U. These dedicated CPT Proprietary Laboratory Analysis (PLA) codes became effective on April 1, 2024.

How do Cardio Diagnostics' (CDIO) PrecisionCHD and Epi+Gen CHD tests differ in their functions?

PrecisionCHD aids in the diagnosis of coronary heart disease by evaluating genetic and epigenetic markers, while Epi+Gen CHD assesses the three-year risk for a CHD event, including heart attacks, using an AI-driven integrated genetic-epigenetic approach.