Back/Cardio Diagnostics Holdings Receives CMS Approval for Groundbreaking Cardiovascular Tests
USA·December 18, 2024·cdio

Cardio Diagnostics Holdings Receives CMS Approval for Groundbreaking Cardiovascular Tests

ED
Editorial
Cashu Markets·3 min read
TL;DR
  • Cardio Diagnostics secures CMS gapfill pricing for its PrecisionCHD and Epi+Gen CHD tests, effective January 1, 2025.
  • The company aims to enhance CHD risk assessment and management through AI-driven genetic and epigenetic testing tools.
  • Cardio Diagnostics' tests will receive CPT codes effective April 1, 2024, facilitating their clinical integration and use.

Cardio Diagnostics Secures CMS Approval for Innovative Cardiovascular Tests

Cardio Diagnostics Holdings, Inc. announces a significant advancement in its operations with the final pricing determinations for its PrecisionCHD and Epi+Gen CHD tests from the Centers for Medicare & Medicaid Services (CMS). Following a preliminary assessment in August 2024, CMS settles on a ‘gapfill’ pricing approach effective for claims made on or after January 1, 2025. This development allows Medicare contractors to establish pricing based on actual cost data provided by Cardio Diagnostics. The company is required to report preliminary gapfill pricing for the year 2025 to CMS by April 1, 2025, a step crucial for the financial sustainability and accessibility of its innovative tests.

Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics, underscores that this milestone is pivotal for improving the risk assessment, diagnosis, management, and monitoring of coronary heart disease (CHD) among Medicare patients. With cardiovascular disease being the leading cause of death in the United States, taking the lives of 702,880 individuals in 2022, and CHD alone responsible for 371,506 of those deaths, the need for advanced diagnostic tools is urgent and pressing. The PrecisionCHD test utilizes artificial intelligence to analyze genetic and epigenetic markers, enhancing the diagnostic accuracy for CHD, while the Epi+Gen CHD test evaluates the risk of CHD events over a three-year period, including the likelihood of heart attacks.

This new pricing structure is part of Cardio Diagnostics' broader strategy to leverage its proprietary AI-driven Integrated Genetic-Epigenetic Engine. The company aims to position itself as a frontrunner in the field of precision cardiovascular medicine, enhancing the prevention, detection, and management of cardiovascular diseases. Both tests are set to receive CPT Proprietary Laboratory Analysis codes from the American Medical Association, effective April 1, 2024, further solidifying their role in the healthcare landscape and facilitating their integration into clinical practice.

In addition to the pricing announcement, Cardio Diagnostics continues to focus on the development and validation of its tests, ensuring they meet the rigorous standards required for clinical implementation. The company’s commitment to utilizing AI in healthcare not only addresses current gaps in cardiovascular disease management but also aims to provide healthcare professionals with the tools necessary to improve patient outcomes significantly.

As Cardio Diagnostics moves forward, the successful implementation of these tests could reshape how coronary heart disease is approached within the Medicare population, potentially setting a precedent for future advancements in precision medicine. For further details, interested parties can visit the company’s website at http://www.cdio.ai/.

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