Summary & Overview
CPT 0118U: Viracor TRAC Donor-Derived Cell-Free DNA Assay
CPT code 0118U identifies the Viracor TRAC™ donor–derived cell–free DNA (dd–cfDNA) assay, a proprietary next-generation sequencing laboratory test used to quantify the percentage of donor-derived cell-free DNA in the blood of solid organ transplant recipients. This biomarker-based molecular assay is used for noninvasive surveillance of allograft injury or rejection, with implications for early detection and post-transplant management. Nationally, adoption of PLA codes like 0118U reflects growth in proprietary, manufacturer‑specific molecular diagnostics that support precision transplant care.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical purpose of the test, payer coverage considerations, and what to expect in reimbursement and utilization benchmarking. The publication examines coding and billing context, common modifiers, typical sites of service, and clinical scenarios driving test utilization. It also summarizes the role of dd–cfDNA monitoring in transplant surveillance and where this PLA code fits within the broader landscape of transplant diagnostics and laboratory billing nationally.
Billing Code Overview
CPT code 0118U is a Proprietary Laboratory Analyses (PLA) code for the Viracor TRAC™ donor–derived cell–free DNA (dd–cfDNA) assay produced by Viracor Eurofins. The test uses next generation sequencing to quantify the percentage of donor-derived cell-free DNA in the blood of a transplant recipient and is intended to monitor for allograft injury or rejection following a solid organ transplant.
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Service type: Laboratory testing using next generation sequencing to measure dd–cfDNA percentage
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Typical site of service: Clinical laboratory or hospital outpatient laboratory performing specialized molecular diagnostics
Clinical & Coding Specifications
Clinical Context
A 52-year-old male recipient of a deceased-donor kidney transplant presents for routine post-transplant surveillance. The patient is 6 months post-transplant, on maintenance immunosuppression, and is asymptomatic with stable serum creatinine but the transplant team orders a donor-derived cell-free DNA test to screen for subclinical allograft injury and early rejection. A peripheral blood sample is collected in the clinic or outpatient phlebotomy unit and sent to Viracor Eurofins for the Viracor TRAC™ dd-cfDNA assay. The laboratory performs next-generation sequencing to quantify the percentage of donor-derived cfDNA; results are returned to the transplant nephrology team to aid interpretation alongside clinical data, labs, and, when indicated, biopsy results. Typical site of service is outpatient transplant clinic, hospital outpatient lab, or contracted reference laboratory; service type is Proprietary Laboratory Analyses (PLA) — specialized molecular diagnostic testing.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unspecified modifier | Rarely used; not typically appended for PLA testing |
11 | Professional component | Used when reporting only the professional component for procedures that have distinct professional components; generally not applicable to PLA testing alone but may apply when separate professional interpretation is billed |
26 | Professional component | Use when billing only the professional interpretation component of a test if the lab separates technical and professional components |
TC | Technical component | Use when billing only the technical component (laboratory processing) of the test performed by the lab |
QK | CLIA complexity waived test performed at site of patient encounter | Not typical for NGS PLA; included if waived test rules ever apply |
QX | CLIA-restricted test performed by laboratory personnel | Use when testing performed by personnel meeting CLIA-moderate/complex requirements as applicable |
QY | CLIA certificate of waiver | Not typical for this NGS test; included for billing environments |
AD | Advanced diagnostic laboratory test | Use when reporting an advanced diagnostic test as defined by payors; may be applied if payor-specific policies require this modifier |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services for assistant at surgery | Generally not applicable; included for completeness when clinician modifiers are needed |
78 | Unplanned return to operating/procedural site by same physician following initial procedure for a related procedure during postoperative period | Not applicable to dd-cfDNA testing but included in provided list |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207RC0000X | Transplant Nephrology | Nephrologists who manage kidney transplant recipients ordering dd-cfDNA testing |
| 207RG0300X | Transplant Surgery | Transplant surgeons involved in postoperative care and surveillance |
| 207RN0401X | Clinical Molecular Genetics Laboratory | Laboratory specialists directing molecular diagnostic testing |
| 207V00000X | Pathology | Pathologists overseeing laboratory testing and interpretations |
| 363L00000X | Clinical Laboratory | Clinical laboratory professionals performing specimen processing and testing |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
T86.10 | Unspecified complication of kidney transplant | General code for transplant-related complications that may prompt dd-cfDNA testing |
T86.11 | Rejection of kidney transplant | Directly relevant when evaluating for suspected or subclinical allograft rejection using dd-cfDNA |
T86.19 | Other complications of kidney transplant | Used for other transplant complications where graft injury surveillance is indicated |
Z94.0 | Kidney transplant status | Used to indicate transplant recipient status on surveillance testing |
N18.9 | Chronic kidney disease, unspecified | Underlying CKD coding in patients pre- or post-transplant where graft function monitoring is needed |
R94.31 | Abnormal results of other serum enzyme tests | Applied when abnormal lab findings prompt further molecular monitoring including dd-cfDNA |
R94.5 | Abnormal results of liver function studies | Example of nonspecific abnormal labs that can be part of post-transplant monitoring (included for completeness) |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0118U | Viracor TRAC™ donor-derived cell-free DNA (dd-cfDNA) assay, quantification by next-generation sequencing | Primary PLA code for this specific proprietary dd-cfDNA test performed by Viracor Eurofins |
36415 | Collection of venous blood by venipuncture | Performed immediately prior to sending the sample to the reference lab for dd-cfDNA testing when collection occurs in clinic or outpatient phlebotomy |
85610 | Prothrombin time; single test | Example of routine coagulation monitoring that may be ordered concurrently in transplant follow-up (ancillary test) |
87491 | Infectious agent detection by nucleic acid (e.g., CMV PCR), quantitative, each organism | Representative molecular diagnostic test often ordered in transplant recipients alongside dd-cfDNA for infection surveillance |
88305 | Level IV surgical pathology, gross and microscopic examination | Renal allograft biopsy interpretation code used when dd-cfDNA results prompt a confirmatory graft biopsy |