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The TriNav Infusion System’s SmartValve technology and Pressure-Enabled Drug Delivery (PEDD) approach is designed to improve delivery of radiopaque media and therapeutic agents to targeted sites in the peripheral vascular system. Interventional Radiology (IR) and Interventional Oncology (IO) procedures such as transarterial simulation angiography and transarterial embolization may employ the TriNav device.
Simulation angiogram Simulation (mapping) angiography is a critical step prior to radioembolization treatment (TARE/Y-90). The mapping procedure serves two purposes:
(1) to delineate normal, variant, and complex vascular (liver/tumor) anatomy, and
(2) assess hepatopulmonary shunting to determine if the patient is a suitable candidate and plan the Y-90 treatment strategy and dose.
Once the blood vessel(s) supplying the tumor has been identified, a radioactive tracer (99Tc-MAA) is injected to mimic the Y-90 particles and their distribution. Nuclear medicine scintigraphy is then performed to analyze how the tracer distributes in the liver and lungs (hepatopulmonary shunting).
Transarterial radioembolization (TARE, Y-90) A minimally invasive therapeutic procedure that combines radiation therapy and embolization to treat liver tumors. Radioactive yttrium-90 (Y-90) microspheres are placed directly into the blood vessel(s) that feed the tumor. This treatment delivers a high dose of radiation to the tumor and the embolization blocks the tumor’s blood supply.
Transarterial chemoembolization (TACE) A minimally invasive procedure that combines chemotherapy and embolization to treat liver tumors. Cancer-fighting drugs (e.g., doxorubicin) is placed directly into the blood vessel(s) that feed the tumor. This treatment cuts off the tumor's blood supply and traps the chemotherapy within the tumor.
Note: Illustrative examples only. Not representative of any particular case. Medical judgment should always be employed by the practitioner.
No. The injection of technetium-99m-macroaggregated albumin (Tc99/ MAA) administered during the Y-90 simulation (mapping) angiogram is not an embolization but rather is part of the subsequent nuclear medicine imaging study. Do not report code 37243 for the injection of Tc99/ MAA.
Road-mapping and confirmation imaging are both used during a therapeutic intervention, but they serve different purposes:
• Road-mapping is used for navigation and guidance, providing a real-time "roadmap" to help guide catheters, wires, or other devices safely through anatomy, like blood vessels.
• Confirmation imaging, on the other hand, is used after a procedure or therapeutic intervention to verify (confirm) its success or outcome.
Per their CPT/HCPCS descriptors, vascular embolization and occlusion codes (37241-37244, C9797) include all image guidance required to complete the procedure. Imaging (regardless of equipment used) performed as guidance during the embolization procedure and as follow-up after the embolization procedure is considered bundled.
NCCI is a system of claim processing edits created by the Centers for Medicare and Medicaid Services (CMS). They are designed to prevent ‘improper’ payments in healthcare claims by providing guidance on what are deemed inappropriate CPT code combinations. NCCI coding policies and edits address procedures or services performed by the same provider for the same beneficiary on the same date of service.
The NCCI program includes 3 types of edits: NCCI Procedure-to-Procedure (PTP) edits, Medically Unlikely Edits (MUEs), and Add-on Code (AOC) Edits.
• Procedure-to-Procedure (PTP) Edits – Codes (CPT/HCPCS) are identified as inclusive (bundled) or mutually exclusive to one another. Each edit has a Column 1/ Column 2 (Comprehensive/Component) designation. If a physician/hospital outpatient claim contains the two codes of an edit pair for the same beneficiary on the same date of service, the Column 1 code is eligible for payment, but the Column 2 code is denied unless an NCCI PTP modifier (-59, XE, XP, XS, & XU) is clinically warranted and appended to the Column 2 code.
• Medically Unlikely Edits (MUEs) – MUEs limit the number of times a specific CPT/HCPCS code may be reported by the same provider/supplier for the same beneficiary on the same date of service. Not all CPT/HCPCS codes have an MUE.
• Add-on Code (AOC) Edits - Add-on code edits define what procedure each add-on code can be reported with. In the CPT Codebook, there are procedures designated as add-on codes, which are preceded by a + sign. They are intended to be reported with a designated base procedure code. The full listing of add-on codes is found in the back of the CPT Codebook in Appendix D – Summary of CPT Add-on Codes.
The NCCI edits primarily apply to Medicare/Medicaid billed services, but other payers may also use them. CMS updates the edits quarterly. See: Medicare NCCI Policy Manual | CMS.
NCCI PTP modifiers provide a means to override a PTP edit but they should only be used when appropriate. For guidance on appropriate use of PTP modifiers, refer to: MLN1783722 - Proper Use of Modifiers 59, XE, XS, XP & XU
Per CPT guidelines, the term ‘surgical field’ is defined as the area immediately surrounding and directly involved in a treatment or procedure. For vascular embolization and occlusion procedures (37241-37244, C9797), only one embolization code may be reported for each surgical field. For additional information regarding ‘surgical field’, see CPT Assistant, May 2024 and November 2013.
Yes. Transarterial radioembolization (TARE, Y-90) is typically a two-stage process: a planning phase and a treatment phase. In the first phase, simulation (mapping) angiography is performed to determine optimal Y-90 treatment strategy and dose. The second phase is where the Y-90 radioembolization is performed. The individual stages are usually staggered over multiple dates of service.
If simulation (mapping) angiography and transarterial radioembolization (TARE, Y-90) are performed on one date of service, each stage is expected to be delivered sequentially in separate sessions. The medical record should clearly identify the services performed during each session in distinct procedural reports. CPT codes for each session are reported the same as if performed on different dates of service. However, the resulting mix of complex coding (e.g., multiple catheter placements, RS&I codes for angiography, etc.) will trigger NCCI PTP edits. As appropriate, a PTP modifier (e.g., -59, XS, XU) may be required.
NCCI PTP modifiers provide a means to override a PTP edit but they should only be used when appropriate. For guidance on appropriate use of PTP modifiers, refer to: MLN1783722 - Proper Use of Modifiers 59, XE, XS, XP & XU
Hospital / facility coding typically includes the following CPT codes:
Ultrasound guidance for vascular access
• 76937
Catheter Placement(s)
• 36245-36248
TACE / Chemotherapy Administration
• C9797
• 96420
Vascular Access Closure
• G0269
Facility Supply Charges
• C1982
• Chemotherapy drug(s)
Important Note: CPT/HCPCS codes provided above are for consideration only. Documentation in the medical record determines final code assignment.
Hospital / facility coding typically includes the following CPT codes:
Ultrasound guidance for vascular access
• 76937
Catheter Placement(s)
• 36245-36248
TARE / Y-90 Treatment
• C9797
• 79445
Vascular Access Closure
• G0269
Facility Supply Charges
• C1982
• C2616
Important Note: CPT/HCPCS codes provided above are for consideration only. Documentation in the medical record determines final code assignment.
Yes, hospitals / facilities may report code 79445 when a radioisotope (e.g., Y-90) is administered during a therapeutic transarterial radioembolization (TARE) procedure. Documentation of the precise location where the radiopharmaceutical was administered, including the specific dose delivered, should be clearly recorded in the medical record. In addition, code 79445 requires an ‘Authorized User (AU)’ be on record for the handling and measurement of the radioisotope.
C8004 and C9797 are HCPCS Level II codes describing medical procedures which are different from the HCPCS Level II codes defining supplies (e.g., C1982, C2626). The key difference between C8004 and C9797 lies in the distinct procedure each one depicts:
• C8004 describes simulation angiography utilizing a pressure-generating catheter (e.g., one-way valve, intermittently occluding), inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the angiogram, specifically for the diagnostic mapping evaluation prior to subsequent therapeutic radioembolization of tumors.
• C9797 describes a therapeutic vascular embolization procedure with use of a pressure-generating catheter (e.g., one-way valve, intermittently occluding), inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention, to deliver treatment for tumors, organ ischemia, or infarction.
C8004 is specific to transcatheter simulation angiography. This may be referred to as the Y-90 work up or the ‘mapping’ procedure. It is diagnostic in nature, describing imaging typically performed on a date separate from a treatment embolization. On the hospital / facility claim, C8004 is reported instead of codes 75726,75774. Under OPPS, HCPCS code C8004 is assigned to APC 5193 – Level 3 Endovascular Procedures.
C9797 is specific to a therapeutic vascular embolization procedure. This may be a Transarterial radioembolization (TARE, Y-90), a Transarterial chemoembolization (TACE), or other transcatheter vascular embolization. It is therapeutic in nature, created to reflect the complexity of this medical therapy. On the hospital / facility claim, C9797 is reported instead of codes (37241-37244). Under OPPS, HCPCS code C9797 is assigned to APC 5194 – Level 4 Endovascular Procedures.
HCPCS C8004 and C9797 both require the use of a pressure-generating catheter. The TriNav Infusion System with its SmartValve technology may be used during the procedures described by HCPCS C8004 and C9797.
Hospitals / facilities should report a HCPCS Level II procedure code (C8004 or C9797) along with the HCPCS Level II code C1982 for the supply. It is recommended that the medical record clearly documents that a pressure generating catheter was utilized.
Codes C8004 and C9797 should never be reported for the same session.
HCPCS code C2616 describes a brachytherapy source, non-stranded, yttrium-90 (Y-90), per source. This is a type of radiation therapy where the radioactive source (Y-90 microspheres) is injected through a catheter, directly into the blood vessel(s), strategically targeting vascular tumor(s). Due to the microsphere size, the Y-90 gets trapped inside the tumor and delivers a radiotherapeutic effect.
The Y-90 dose administration is part of a therapeutic transarterial radioembolization (TARE) procedure. Documentation of the precise location where the radiopharmaceutical was administered, including the specific dose delivered, should be clearly recorded in the medical record. HCPCS Level II code C2616 may be reported on the hospital / facility claim when Y-90 brachytherapy is administered.
C2616 is used to bill for the radioactive material (y-90) itself. The 2025 Medically Unlikely Edits (MUE) is 1, with MAI of 3. Under OPPS, HCPCS code C2616 reflects payment indicator ‘H2’, brachytherapy source paid separately when integral to a surgical procedure; payment based on OPPs rate.
HCPCS code C1982 describes a catheter, specifically a pressure-generating, one-way valve, intermittently occlusive catheter. This type of catheter is designed to more effectively control blood flow and medication delivery during transcatheter vascular procedures.
When documented in the medical record, HCPCS Level II code C1982 may be reported on the hospital / facility claim when the TriNav system is utilized.
C1982 is used to bill for the pressure-generating, one-way valve, intermittently occlusive catheter (supply) itself. The 2025 Medically Unlikely Edits (MUE) is 1, with MAI of 3. Under OPPS, HCPCS code C1982 reflects payment indicator ‘N1’, packaged service/item; no separate payment.
Yes, but only under very specific conditions. Documentation of the precise location where the radiopharmaceutical was administered, including the specific dose delivered, should be clearly recorded in the medical record.
Code 79445 requires an ‘Authorized User (AU)’ be on record for the safe handling and measurement of the radioisotope. IR / IO physicians may report code 79445 for the radiotherapeutic injection of Y-90 if they meet the regulatory requirements. Recommend consulting your regulatory, compliance, and legal authorities on this matter. Additional information on ‘Authorized User’ can be found here: How to Obtain Authorized User Status - American Society for Radiation Oncology (ASTRO)
For a transarterial chemoembolization (TACE) treatment, physician coding typically includes the following CPT codes:
Ultrasound guidance for vascular access
• 76937-26
Catheter Placement(s)
• 36245-36248
TACE Treatment
• 37243
Important Note: CPT codes provided above are for consideration only. Documentation in the medical record determines final code assignment.
For a transarterial radioembolization (TARE) treatment, physician coding typically includes the following CPT codes:
Ultrasound guidance for vascular access
• 76937-26
Catheter Placement(s)
• 36245-36248
TARE / Y-90 Treatment
• 37243
• 79445-26 *if documented as Authorized User (AU)
Important Note: CPT codes provided above are for consideration only. Documentation in the medical record determines final code assignment.
Per the CPT Codebook, vascular embolization procedure (37241-37244) include:
• All associated radiological supervision and interpretation (RS&I)
• Intra-procedural guidance and road-mapping
• Imaging necessary to document completion of the procedure
Separately reportable services:
• Ultrasound guidance for vascular access
• Vessel selection(s) and catheter placement(s)
• Diagnostic angiography (append -59 or XU modifier when appropriate)
• Injection of radioisotope (e.g., 79445)
• Chemotherapy administration (e.g., 96420)
Vascular embolization may be performed in various areas of the body for a wide variety of medical conditions. The AMA created a family of CPT codes (37241-37244) to describe vascular embolization and occlusion procedures (non-central nervous system and head and neck). Code options are broken out by clinical indication. The CPT code representing the immediate medical need for treatment during a single patient encounter should be used. Arteries, veins, and lymphatics may all be targets of vascular embolization.
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TriNav LV employs the same SmartValve® technology as TriNav to enable the PEDD approach in larger vessels.
Indications for Use
The TriNav, TriNav FLX, and TriNav LV Infusion Systems are intended for use in angiographic procedures. They deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.¹²³
Contraindications
The TriNav, TriNav FLX, and TriNav LV Infusion Systems are not indicated for use in the vasculature of the central nervous system (including the neurovasculature) or central circulatory system (including the coronary vasculature).¹²³
Rx Only
For the safe and proper use of the TriNav, TriNav FLX, and TriNav LV Infusion Systems, refer to their individual Instructions for Use.
References
1. TriSalus™ TriNav® Infusion System Instructions for Use.
2. TriSalus™ TriNav® FLX Infusion System Instructions for Use.
3. TriSalus™ TriNav® LV Infusion System Instructions for Use.
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