Cardio Diagnostics to Participate in the Centers for Medicare and Medicaid Services’ (CMS) Clinical Laboratory Fee Schedule (CLFS) Annual Meeting to Secure Medicare Payment for Its Innovative Tests
Cardio Diagnostics Holdings announced its participation in the CMS CLFS Annual Meeting on June 25, 2024. The company will recommend pricing for its Epi+Gen CHD and PrecisionCHD tests for Medicare payment under the CLFS for 2025. CMS will release proposed determinations by early September 2024 and final decisions in November 2024. The tests were recently awarded CPT PLA codes (0439U and 0440U) by the AMA, effective April 1, 2024. Additionally, Cardio Diagnostics is pursuing coverage through the MolDx program with a pre-submission meeting scheduled for Q3 2024. CEO Meesha Dogan emphasized the importance of these steps in making the tests accessible to Medicare beneficiaries. The Epi+Gen CHD test assesses the three-year risk for CHD events, while PrecisionCHD aids in diagnosing CHD. These tests aim to improve detection, prevention, and management of CHD among Medicare patients, who are at high risk for heart disease.
- Participation in CMS CLFS Annual Meeting is a significant step towards securing Medicare payment for Epi+Gen CHD and PrecisionCHD tests.
- CMS determinations will set payment rates under CLFS for 2025.
- Epi+Gen CHD and PrecisionCHD tests recently awarded dedicated CPT PLA codes by the AMA, effective April 1, 2024.
- Pre-submission meeting with MolDx program is scheduled for Q3 2024 to discuss coverage options.
- Epi+Gen CHD test evaluates genetic and epigenetic markers to assess three-year CHD risk, aiding in prevention and management.
- PrecisionCHD test aids in diagnosing CHD, potentially improving clinical decision-making and patient outcomes.
- Tests aim to reduce morbidity, mortality, and healthcare costs among Medicare beneficiaries, addressing a critical need for advanced diagnostic tools.
- CMS final determinations for payment rates will not be available until November 2024, creating a period of uncertainty.
- Success in securing Medicare payment and MolDx program coverage is not guaranteed, posing a potential financial risk.
- Delay in securing Medicare payment could impact the company's revenue projections and market penetration.
Company to recommend pricing for its Epi+Gen CHD and PrecisionCHD tests, and pursue coverage via the Molecular Diagnostic Services (MolDx) program.
At the CLFS Annual Meeting, Cardio Diagnostics will submit information and recommendations to support the establishment of payment amounts for its Epi+Gen CHD and PrecisionCHD tests. Taking into account the feedback received during the meeting, CMS is expected to share proposed determinations by early September 2024. This will include the basis for each payment amount recommendation and a request for public comments.
Final determinations, including the rationale supporting each decision, is expected to be posted on the CMS website in November 2024. These determinations will be crucial in setting the payment rates under the CLFS for calendar year 2025 for the Company’s Epi+Gen CHD and PrecisionCHD that were recently awarded dedicated CPT Proprietary Laboratory Analyses (PLA) codes by the American Medical Association (AMA). The codes are 0439U for Epi+Gen CHD and 0440U for PrecisionCHD, and went effective April 1, 2024.
"Participating in the CLFS Annual Meeting is a critical step towards securing Medicare payment for our innovative tests," stated Meesha Dogan, PhD, CEO and Co-Founder of Cardio Diagnostics. "Our cutting-edge tests represent a significant advancement in the prevention, detection and management of coronary heart disease, and we are committed to making them accessible to Medicare beneficiaries."
In addition to engaging with the CLFS process, Cardio Diagnostics is actively pursuing coverage through the Molecular Diagnostic Services (MolDx) program. A pre-submission meeting with MolDx is scheduled for Q3 2024 to further discuss coverage options for Epi+Gen CHD and PrecisionCHD.
Cardio Diagnostics will present information for its two flagship tests: Epi+Gen CHD and PrecisionCHD. Epi+Gen CHD is an AI-powered blood-based DNA test that evaluates genetic and epigenetic markers to assess the three-year risk for a symptomatic coronary heart disease (CHD) event, including heart attacks. PrecisionCHD is an AI-powered blood-based DNA test that evaluates genetic and epigenetic markers to aid in diagnosing CHD. Both tests
According to the CMS, heart disease remains the leading cause of death among Medicare beneficiaries, with about
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 www.cardiodiagnosticsinc.com.
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 results are discussed in the Current Report on Form 10-K for the period ended December 31, 2023, and Form 10-Q for the period ended March 31, 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/20240521946732/en/
Investors:
Gene Mannheimer
Investor Relations
855-226-9991
investors@cardiodiagnosticsinc.com
Media & Public Relations:
Khullani Abdullahi
855-226-9991
pr@cardiodiagnosticsinc.com
Source: Cardio Diagnostics Holdings, Inc.
FAQ
What is the significance of Cardio Diagnostics' participation in the CMS CLFS Annual Meeting?
When will CMS release proposed payment determinations for CDIO's tests?
What are the CPT PLA codes for Cardio Diagnostics' tests?
What is the purpose of the Epi+Gen CHD test?
How does the PrecisionCHD test aid in diagnosing CHD?
What is the MolDx program and its significance for CDIO?
Why are advanced diagnostic tools like Epi+Gen CHD and PrecisionCHD important for Medicare patients?
