Summary & Overview
CPT 0320U: Tuteva™ NGS Transcriptome Assay for Kidney Transplant Rejection
CPT code 0320U designates Tuteva™, a proprietary next-generation sequencing (NGS) transcriptome assay from Verici Dx Inc. used on blood specimens after kidney transplant to evaluate immune-related gene expression and produce an algorithm-derived risk score for acute or subclinical graft rejection. As a PLA code, 0320U applies exclusively to this single manufacturer's test, making it important for laboratory billing, payer policy, and transplant management pathways nationally.
Key payers referenced in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise explanation of the test and its clinical context, national coverage considerations, and common billing elements. The publication provides benchmarks and policy-relevant updates where available, plus clinical context for transplant programs, laboratory directors, and revenue cycle teams on when this NGS-based transcriptome assay is billed and documented.
The report clarifies service type and typical site of service, outlines payer coverage patterns and gaps, and summarizes operational considerations for billing and claims submission related to proprietary laboratory analyses. Data not available in the input are noted where applicable.
Billing Code Overview
CPT code 0320U is a Proprietary Laboratory Analyses (PLA) code that applies only to the Tuteva™ test from Verici Dx Inc. The test analyzes a blood specimen from a patient following a kidney transplant using next-generation sequencing (NGS) of specific portions of the transcriptome (mRNA) to evaluate gene expression related to immune response. An algorithmic analysis of the sequencing results produces a risk score for acute or subclinical graft rejection.
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Service type: Laboratory molecular diagnostic test using next-generation sequencing and transcriptome-based algorithmic analysis
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Typical site of service: Clinical laboratory or reference laboratory processing blood specimens from post-kidney-transplant patients
Data not available in the input.
Clinical & Coding Specifications
Clinical Context
A 52-year-old male patient presents for routine post-kidney transplant surveillance at 3 months post-transplant. The patient is clinically stable on maintenance immunosuppression but has rising serum creatinine over several lab draws without clear cause on ultrasound and standard serologic testing. The transplant nephrologist orders a blood-based gene expression assay, Tuteva™ (0320U), which uses next-generation sequencing of targeted mRNA and an algorithmic risk score to evaluate immune activation consistent with acute or subclinical allograft rejection. A peripheral blood specimen is collected in the outpatient clinic or phlebotomy lab and sent to the performing laboratory per the manufacturer's instructions. Results return as a risk score that the transplant team incorporates with clinical assessment, serum labs, and potential biopsy planning. Typical sites of service are outpatient transplant clinic, hospital outpatient phlebotomy, or an ambulatory reference laboratory encounter.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier or not otherwise specified | Rarely reported; placeholder in some payer systems when no specific modifier applies |
26 |