Cardio Diagnostics Receives Final Gapfill Payment Rates for AI-Driven Cardiovascular Tests from the Centers for Medicare and Medicaid Services (CMS)

Key Terms

gapfill payment rate regulatory

Gapfill payment rate is the reimbursement level set by local or regional payers when there is no established national price for a new medical service, procedure code, or device; think of it as a temporary local sticker price until a standardized one is adopted. It matters to investors because these interim rates determine near-term revenue for providers and device makers, and wide variation or low gapfill rates can materially affect earnings and adoption.

Centers for Medicare and Medicaid Services (CMS) regulatory

The Centers for Medicare & Medicaid Services (CMS) is a U.S. federal agency that runs the country’s major public health insurance programs and sets rules for how providers get paid and how medical products are covered. Investors care because CMS decisions on coverage, payment rates, and rules can change how much revenue healthcare companies earn—think of CMS like a giant client or regulator whose pricing and coverage choices can make or break a product’s market.

CPT Proprietary Laboratory Analysis (PLA) codes regulatory

CPT Proprietary Laboratory Analysis (PLA) codes are unique billing and identification numbers assigned to new, company-developed laboratory tests to track use and reimbursement in the U.S. healthcare system. Think of them like product SKUs for diagnostic tests: they make it easier for labs and insurers to recognize and pay for a specific test, so having a PLA code can influence a developer’s revenue, pricing power and the speed at which a test is adopted by clinicians and payers—factors investors watch closely.

epigenetic medical

Epigenetic describes changes that alter how genes are turned on or off without changing the underlying DNA sequence, similar to flipping light switches or adjusting software settings that control a machine. For investors, epigenetic mechanisms matter because they create new targets for drugs, diagnostics, and therapies that can modify disease processes or patient responses, potentially leading to novel products, market opportunities, and long-term revenue streams.

genetic medical

Relating to genes or heredity, genetic describes the information in DNA that shapes an organism’s traits, like an instruction manual passed from parent to child. For investors, genetic developments matter because they drive research, diagnostic tests, and therapies whose success, patents and regulation can create big market opportunities or risks; think of breakthroughs as unlocking new product lines or unexpected liabilities in a business.

The final gapfill payment rate for both the Epi+Gen CHD™ and PrecisionCHD™ tests is higher at $854 compared to the preliminary gapfill payment rates of $350 for Epi+Gen CHD™ and $684.76 for PrecisionCHD™.

CHICAGO--(BUSINESS WIRE)-- Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-powered precision cardiovascular medicine company, today announced that the Centers for Medicare and Medicaid Services (CMS) has issued a final gapfill payment rate of $854 for both the Epi+Gen CHD™ and PrecisionCHD™ tests. This finalized rate represents an increase from the preliminary gapfill payment rates of $350 for Epi+Gen CHD™ and $684.76 for PrecisionCHD™. Obtaining the final rate represents a positive development and will be effective for claims with dates of service on or after January 1, 2026.

“We are pleased with the final payment rate,” said Meesha Dogan, PhD., CEO and Co-Founder of Cardio Diagnostics. “Obtaining the final rate is a significant step in our efforts to expand access to our advanced cardiovascular tests for Medicare beneficiaries.”

Cardiovascular disease remains the leading cause of death in the United States, particularly among Americans aged 65 and older. In 2022 alone, over 700,000 Americans died from heart disease, with coronary heart disease (CHD) accounting for more than 370,000 deaths.

PrecisionCHD™ is a groundbreaking AI-powered test designed to aid in the diagnosis of CHD by analyzing both genetic and epigenetic markers. Meanwhile, Epi+Gen CHD™ provides insight into a patient’s three-year risk for a CHD event, such as a heart attack. Both tests are performed from a simple blood draw, enabling scalable, accessible, and non-invasive cardiovascular assessment. 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 became 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 https://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, and dependence on results as discussed in the Annual Report on Form 10-K for the period ended December 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/20251203479342/en/

Investors

Investor Relations

855-226-9991

investors@cdio.ai

Media & Public Relations

Public Relations

855-226-9991

pr@cdio.ai

Source: Cardio Diagnostics Holdings, Inc.