TriSalus Life Sciences Granted Expanded CMS Reimbursement for TriNav Infusion System

February 9, 2021—TriSalus Life Sciences, an immuno-oncology company focused on treatment for liver and pancreatic tumors, announced that the Centers for Medicare & Medicaid Services (CMS) has expanded authorization for transitional pass-through (TPT) payment for the company’s TriNav infusion system.

TriSalus advised that the device may now be used with the procedure code (37242) for vascular embolization or occlusion in the artery, which is common for pretreatment mapping in Y-90 procedures. This is in addition to the previously approved use of procedure code (37243) for vascular embolization or occlusion in organs.

The January 1, 2021 clarification confirms CMS will make TPT payments when either code is appropriately reported in association with TriNav and TPT HCPCS Code C1982, the company said.

TriSalus describes TriNav as a flexible, ultra-thin therapy delivery system with SmartValve technology, a self-expanding, nonocclusive one-way microvalve. The company stated that this system for the pressure-enabled drug delivery (PEDD) approach has demonstrated the ability to overcome intratumoral pressure in solid tumors and potentially improve distribution and penetration of therapy during transcatheter arterial chemoembolization and transcatheter arterial radioembolization procedures.

According to the company, TriNav has now met the required criteria to receive TPT status for vascular embolization or occlusion of both organs and arteries. The company noted that the Medicare TPT payment program is designed to foster innovation and increase access to cutting edge treatments that benefit patients. CMS believes the program is important for hospitals to receive TPT payment for products that offer substantial clinical improvement, noted TriSalus.

“We’re pleased that CMS recognizes the innovative benefit of TriNav,” commented TriSalus President and CEO Mary Szela in the announcement. “TriNav is helping interventional radiologists eliminate the potential variables that may be created by the use of different devices for pretreatment mapping and treatment. This is believed to help ensure consistency in the perfusion pattern between the two procedures for optimal dose delivery during the embolization.”

Szela continued, “As we work to overcome some of the most significant challenges in cancer care, this expanded reimbursement allows providers to continue to pursue the benefit of using PEDD, which offers a unique mechanism for therapy delivery to selected sites in the peripheral vascular system, including hepatocellular carcinoma and other solid tumors in the liver and pancreas.”