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.

Service type: Laboratory molecular diagnostic test using next-generation sequencing and transcriptome-based algorithmic analysis
Typical site of service: Clinical laboratory or reference laboratory processing blood specimens from post-kidney-transplant patients

Data not available in the input.

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`

Taxonomy Code	Specialty	Notes
207L00000X	Transplant Nephrology	Transplant nephrologists order and interpret results in post-transplant care
207R00000X	Nephrology	General nephrologists manage kidney transplant recipients and use results for decision-making
2080P0207X	Clinical Laboratory Director	Laboratory directors oversee PLA testing validation, performance, and reporting
363LF0000X	Clinical Molecular Genetics	Molecular pathology or genetics specialists may validate NGS-based assays and algorithms
207K00000X	Internal Medicine	Hospitalists or internists involved in inpatient transplant care may order or act on results

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`T86.101`	Complications of kidney transplant, unspecified	General code for post-transplant complications when evaluating graft dysfunction
`T86.102`	Complications of kidney transplant, acute rejection	Directly relevant when assessing for acute rejection risk with the gene expression assay
`N18.9`	Chronic kidney disease, unspecified	Background chronic kidney disease in the transplant recipient used in clinical context
`R94.4`	Abnormal results of other specific organ function studies	Used when abnormal laboratory surveillance prompts further diagnostic testing including PLA assays
`Z48.21`	Encounter for aftercare following kidney transplant	Surveillance encounters where the test is commonly ordered

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Commonly performed immediately prior to sending the blood specimen for the PLA test
`89579`	Therapeutic drug monitoring (e.g., immunosuppressant levels) — note: code varies by payer	Frequently ordered in parallel to assess immunosuppressant exposure when evaluating graft dysfunction
`88305`	Level IV surgical pathology, gross and microscopic examination (biopsy)	Renal allograft biopsy coding when tissue diagnosis is obtained following a high-risk gene expression result
`83970`	Therapeutic drug assay, quantitative (e.g., tacrolimus)	Laboratory measurement of immunosuppressant levels often performed alongside transcriptomic testing
`99000`	Handling and/or conveyance of specimen to laboratory (miscellaneous)	May be used by some facilities to capture additional specimen handling costs for specialized PLA testing

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Summary & Overview