Acarix Expands U.S. Reimbursement Coverage for CADScor System for use in Emergency and Outpatient Settings

Rhea-AI Summary

Acarix announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned CPT code 0716T for the CADScor System to APC 5733 with 'S' (separately payable) status for 2025. This decision enables standalone fixed reimbursement for CADScor in outpatient settings, including emergency rooms and ambulatory surgery centers. The CADScor System is a non-invasive, AI-powered diagnostic tool that rules out Coronary Artery Disease with 97% accuracy in under 10 minutes. The system is FDA-cleared, CE-marked, protected by over 40 patents, and has been used on more than 40,000 patients with symptomatic chest pain.

Positive

• Secured standalone fixed reimbursement coverage from CMS for outpatient settings
• System achieves 97% accuracy in CAD diagnosis
• Protected intellectual property with over 40 patents
• Established market presence with 40,000+ patient usage
• Expected positive influence on private payer reimbursement decisions

Negative

• None.

MALMÖ, Sweden, Nov. 4, 2024 /PRNewswire/ -- Acarix, a leader in rapid AI and acoustics-based cardiac diagnostics, announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) has decided that the CPT code 0716T - the CADScor® System - shall be assigned to APC 5733 including status indicator assignment to "S" (separately payable) for calendar year 2025. The CMS ruling means standalone fixed reimbursement is now possible for the CADScor System in outpatient settings.

"Locking in guaranteed reimbursement for the CADScor System is a huge win for Acarix and will allow for rapid growth throughout the U.S. in a multitude of healthcare settings," said Aamir Mahmood, Acarix President and CEO. "Having a fixed CADScor reimbursement as a standalone service rather than packaged in a 'global code' with other diagnostic tests will give us a clear sight as demand for and usage of the CADScor System accelerates in the U.S."

CMS's decision means that when the CADScor System is used in the APC/outpatient setting, including in emergency rooms and ambulatory surgery centers (ASC), it will be paid. This "S" code will give healthcare providers the ability to submit reimbursement claims via their standard billing processes.

"The certainty of payment that comes with CMS's "S" code decision will greatly accelerate CADScor System usage in ER and ambulatory settings throughout the U.S.," said Dr. George Chrysant, Chief Medical Officer for INTEGRIS Health Heart Hospital/INTEGRIS Health Cardiovascular Physicians in Oklahoma City, OK. "This decision shows that CMS sees CADScor as a first-in-class product and I am very pleased CMS has already committed to re-evaluate the reimbursement rate once the system is in widespread use, which we are confident will happen in 2025."

This CMS decision will likely also influence pending private payer reimbursement decisions, as CMS is looked to for guidance as the first step to ensuring secured payment.

"This decision will have a domino effect on private payers across the U.S.," said Mahmood. "This is what we have been waiting for to really accelerate growth in the U.S. market and get this new technology in the hands of more doctors across the country."

The Acarix CADScor is a non-invasive, radiation free diagnostic aid powered by AI to rule out Coronary Artery Disease (CAD) with 97% accuracy in less than 10 minutes. The CADScor System is CE- and FDA-cleared, covered by more than 40 patents and used on over 40,000 patients with symptomatic chest pain.

For more information, contact:
Ashley Wilson, phone +1405 413 5201, email awilson@saxum.com 

About Acarix
Acarix is a Swedish medical device company that innovates solutions for rapid rule out of coronary artery disease (CAD) at point of care. The CE-approved and FDA DeNovo-cleared Acarix CADScor System is intended for patients experiencing chest pain with suspected CAD and designed to help reduce millions of unnecessary, invasive, and costly diagnostic procedures. The CADScor System has been used on more than 29,000 patients. Acarix recommends CADScor System as a first-line diagnostic aid that uses highly sensitive acoustics and advanced computational processing to analyze coronary blood flow to rule out significant coronary artery disease (CAD), with at least 96% certainty at point of care. Acarix is listed on the Nasdaq First North Premier Growth Market in Stockholm (ticker: ACARIX) and cross-traded on the OTCQB market in the U.S. (ticker: ACIXF). Carnegie Investment Bank is the Certified Advisor of Acarix. For more information, please visit www.acarix.com.

 

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SOURCE Acarix

FAQ

What is the new CMS reimbursement status for Acarix (ACIXF) CADScor System in 2025?

CMS assigned CPT code 0716T for the CADScor System to APC 5733 with 'S' (separately payable) status, enabling standalone fixed reimbursement in outpatient settings for 2025.

What is the accuracy rate of Acarix (ACIXF) CADScor System for detecting Coronary Artery Disease?

The CADScor System achieves 97% accuracy in ruling out Coronary Artery Disease in less than 10 minutes.

How many patients have been tested with Acarix (ACIXF) CADScor System?

The CADScor System has been used on over 40,000 patients with symptomatic chest pain.