VentureMed’s Flex Vessel Prep System Receives CMS Transitional Pass-Through Payment

November 8, 2023—VentureMed Group, Inc. announced that the Center for Medicare & Medicaid Services (CMS) has granted the company’s Flex vessel prep (VP) system a transitional pass-through (TPT) payment category a new Healthcare Common Procedure Coding System C-code effective January 1, 2024. The code will remain in effect for the next 2 to 3 years.

VentureMed Group is a medical device company focused on access management for arteriovenous fistulas and grafts and vessel preparation for interventional treatment of peripheral artery disease.

According to the company, the Flex VP system is a nonballoon-based approach to optimizing revascularization of complex stenoses and lesions of any length or vessel morphology. The TPT payment provides outpatient facilities with an incremental Medicare payment for procedures in which the Flex VP is used.

“CMS approval of a TPT for VentureMed’s Flex device is monumental and will provide access of this novel technology to many deserving patients,” commented dialysis access surgeon John Ross, MD, in the company’s press release. “The dialysis access community is well served by this positive decision.” Dr. Ross is Founder of The Dialysis Access Institute in Orangeburg, South Carolina.

The company noted that TPT payments provide additional payment for new devices, drugs, and biologicals that meet eligibility criteria. They are intended to help facilitate patient access to technologies that are too new to be well represented in the data that CMS use to set Outpatient Prospective Payment System payment rates.

The Flex VP system has received FDA 510(k) clearance in the United States and CE Mark approval in Europe. In September 2023, the company announced it received European Medical Device Regulation (MDR) certification for the device.

Denis Harrington, VentureMed’s President and CEO, stated in the press release, “This is an exciting time for VentureMed. This new C-code supports access for our Flex VP system for hospitals and ambulatory service centers. Our reimbursement team provided a complete and thorough review of the product and our clinical results, which resulted in TPT approval.”

Harrington continued, “This approval was granted in part based on Flex VP meeting CMS criteria for substantial clinical improvement over the existing standard of care. Combined with our recently announced achievement of MDR certification, this approval continues to underscore VentureMed’s commitment to optimal patient care. I am proud of the team and excited for the growth this will enable.”