TriSalus Life Sciences®, Inc. (“TriSalus” or the “Company”) (Nasdaq: TLSI), which seeks to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies and our investigational immunotherapy, announced today that the Centers for Medicare & Medicaid Services (CMS) has established a new Level II HCPCS code for the TriNav® Infusion System, effective April 1, 2025. This new code, C8004, provides reimbursement clarity for simulation angiograms—commonly known as mapping procedures—conducted prior to transarterial radioembolization (TARE).
The introduction of C8004 provides validation of TriNav’s growing role in pre-treatment mapping for Transarterial Radioembolization, reinforcing its value in optimizing Y90 dose delivery.
“With this new code, Interventional Radiologists and Medicare patients have access to PEDD for radioembolization procedures with full reimbursement for both mapping and treatment,” said Mary Szela, CEO of TriSalus. “Using PEDD technology for both the mapping and treatment procedures in radioembolization helps ensure accurate treatment planning and delivery which is crucial for delivering the radioactive microspheres to the tumor with precision.”
Dr. Richard Marshall, who serves as Medical Director for TriSalus, stated:
“In my current practice, using the same catheter for both mapping and treatment helps enhance the accuracy of Y90 dose delivery. I can achieve a higher T:N ratio with the TriNav Infusion System, and I have seen that its high concordance between mapping and treatment allows better prediction of the dose which can improve personalized dosimetry.”
HCPCS Code C8004 Details
- Description: Simulation angiogram utilizing a pressure-generating catheter (e.g., one-way valve, intermittently occluding), including all radiological supervision and interpretation, intraprocedural road mapping, and imaging guidance necessary for subsequent therapeutic radioembolization of tumors.
- Effective Date: April 1, 2025
- Eligible Reporting Facilities: Hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs)
- Medicare Payment Rate: $11,341 under APC 5193
TriSalus’ initial analysis indicates that the reimbursement level under C8004, combined with standard Medicare payment adjustments, will support continued adoption of TriNav for both mapping and treatment.
For more information, the full CMS Quarterly Update can be found [here].
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