EvoEndo, Inc. (“EvoEndo”), a medical device company developing systems for Unsedated Transnasal Endoscopy (TNE), is pleased to share recent decisions announced by the Centers for Medicare and Medicaid Services (CMS) in its CY 2023 Hospital Outpatient Prospective Payment System (OPPS) final rule.
Based on information submitted to CMS including the cost of the EvoEndo Model LE Single-Use Gastroscope and its recent 510(k) FDA clearance, CMS decided to modify the APC assignments for CPT codes 0652T, 0653T and 0654T. Effective July 1, 2023, the APC assignment for CPT 0652T (transnasal diagnostic EGD) and 0653T (transnasal EGD with biopsy) will change from APC 5301 (Level 1 Upper GI Procedures) to APC 5302 (Level 2 Upper GI Procedures).
Additionally, CPT 0654T (transnasal EGD with insertion of intraluminal tube or catheter) will be moved from APC 5302 (Level 2 Upper GI Procedures) to APC 5303 (Level 3 Upper GI Procedures).1
“We thank CMS for its consideration. We look forward to sharing this new payment alignment with healthcare providers as they consider the clinical and financial value of unsedated transnasal endoscopy,” said Heather Underwood, Chief Executive Officer at EvoEndo.
“Unsedated transnasal endoscopy with the EvoEndo® Single-Use Endoscopy System is designed to reduce preparation and recovery time for upper endoscopy procedures and to eliminate potential risks associated with sedation. This is especially important for our pediatric patients in need of diagnostic endoscopy with Eosinophilic Gastrointestinal Disorders,” remarks Dr. Ali Mencin, Chief of Pediatric Gastroenterology, Hepatology, and Nutrition at Columbia University Medical Center.
The EvoEndo® Single-Use Endoscopy System received FDA 510(k) clearance in February 2022. The EvoEndo System includes a sterile, single-use, flexible gastroscope designed for unsedated transnasal upper endoscopy, and a small portable video controller. The EvoEndo Comfort Kit includes virtual reality (VR) goggles for patient distraction during the unsedated transnasal endoscopy procedure. Unsedated TNE can be used to evaluate and diagnose a wide range of upper GI conditions that may require frequent monitoring, including eosinophilic esophagitis (EoE), dysphagia, celiac disease, gastroesophageal reflux disease, Barrett’s esophagus, malabsorption, and abdominal pain. The EvoEndo System is only intended for use by medical professionals. Physicians and other medical providers interested in learning more about EvoEndo’s TNE system or to schedule demonstrations and training can contact the company here.
