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

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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.

Acarix ha annunciato che i Centri statunitensi per Medicare e Medicaid Services (CMS) hanno assegnato il codice CPT 0716T per il CADScor System all'APC 5733 con stato 'S' (pagabile separatamente) per il 2025. Questa decisione consente il rimborso fisso autonomo per CADScor in contesti ambulatoriali, comprese le sale di emergenza e i centri di chirurgia ambulatoriale. Il CADScor System è uno strumento diagnostico non invasivo, alimentato da intelligenza artificiale, che esclude la malattia coronarica con un'accuratezza del 97% in meno di 10 minuti. Il sistema è autorizzato dalla FDA, contrassegnato CE, protetto da oltre 40 brevetti e utilizzato su più di 40.000 pazienti con dolore toracico sintomatico.

Acarix anunció que los Centros de Servicios de Medicare y Medicaid de EE. UU. (CMS) han asignado el código CPT 0716T para el CADScor System al APC 5733 con estado 'S' (pago por separado) para 2025. Esta decisión permite el reembolso fijo independiente para CADScor en entornos ambulatorios, incluyendo salas de emergencia y centros de cirugía ambulatoria. El CADScor System es una herramienta diagnóstica no invasiva, impulsada por inteligencia artificial, que descarta la enfermedad arterial coronaria con un 97% de precisión en menos de 10 minutos. El sistema cuenta con la autorización de la FDA, está marcado con el CE, protegido por más de 40 patentes y ha sido utilizado en más de 40,000 pacientes con dolor torácico sintomático.

Acarix는 미국 Medicare 및 Medicaid 서비스 센터(CMS)가 CADScor System에 대해 CPT 코드 0716T를 APC 5733으로 할당하며 2025년부터 'S'(별도로 지불 가능) 상태를 부여했다고 발표했습니다. 이 결정은 응급실과 외래 수술 센터를 포함한 외래 환경에서 CADScor에 대한 독립적인 고정 환급이 가능하게 합니다. CADScor System은 10분 이내에 97% 정확도로 관상 동맥 질환을 배제하는 비침습적이며 인공지능 기반의 진단 도구입니다. 이 시스템은 FDA 승인을 받았으며 CE 마크가 부여되었고 40건 이상의 특허로 보호되며, 증상으로 인한 흉통을 앓고 있는 40,000명 이상의 환자에게 사용되었습니다.

Acarix a annoncé que les Centres américains de Medicare et de Medicaid Services (CMS) ont attribué le code CPT 0716T pour le CADScor System à l'APC 5733 avec le statut 'S' (rémunération séparée) pour 2025. Cette décision permet un remboursement fixe autonome pour CADScor dans les établissements ambulatoires, y compris les salles d'urgence et les centres de chirurgie ambulatoire. Le CADScor System est un outil de diagnostic non invasif, alimenté par l'intelligence artificielle, qui exclut la maladie coronarienne avec une précision de 97 % en moins de 10 minutes. Le système est approuvé par la FDA, marqué CE, protégé par plus de 40 brevets et a été utilisé sur plus de 40 000 patients présentant des douleurs thoraciques symptomatiques.

Acarix hat angekündigt, dass die US-Zentren für Medicare und Medicaid Services (CMS) den CPT-Code 0716T für das CADScor System dem APC 5733 mit dem Status 'S' (separat abrechenbar) für 2025 zugeordnet haben. Diese Entscheidung ermöglicht eine unabhängige, feste Erstattung für CADScor in ambulatorischen Einrichtungen, einschließlich Notaufnahme und ambulanten OP-Zentren. Das CADScor System ist ein nicht-invasives, KI-gestütztes Diagnosetool, das mit 97%iger Genauigkeit in weniger als 10 Minuten eine koronare Herzkrankheit ausschließt. Das System ist von der FDA zugelassen, mit einem CE-Zeichen versehen und durch mehr als 40 Patente geschützt, und wurde bei über 40.000 Patienten mit symptomatischen Brustschmerzen eingesetzt.

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.

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