Summary & Overview
CPT 0319U: PreTransplant Risk Assessment (PTRA) via NGS Transcriptome Analysis
CPT code 0319U designates a proprietary PreTransplant Risk Assessment (PTRA) test from Verici Dx Inc. that uses next-generation sequencing of targeted transcriptome regions from a pretransplant blood specimen and an algorithmic analysis to report a risk score for early acute kidney transplant rejection. As a PLA code, 0319U applies only to this single manufacturer’s assay and signals a growing role for molecular, algorithm-driven diagnostics in transplant risk stratification. Nationally, such tests matter for personalized transplant management, utilization of donor organs, and perioperative immunosuppression strategies.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical test and service setting, payer coverage landscape, common billing modifiers, and implications for coding and documentation. The publication provides benchmarks and policy context relevant to laboratory and transplant program stakeholders, highlights coding nuances for a PLA CPT code, and outlines issues payers commonly consider for coverage of novel diagnostic algorithms. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0319U is a Proprietary Laboratory Analyses (PLA) code specific to a single laboratory test: the PreTransplant Risk Assessment (PTRA) from Verici Dx Inc. The test analyzes a patient blood specimen collected prior to kidney transplant and uses 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 generates a score that estimates the risk of early acute transplant rejection.
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Service type: Laboratory molecular diagnostic test using next-generation sequencing and algorithmic interpretation to produce a clinical risk score for early acute kidney transplant rejection.
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Typical site of service: Clinical laboratory or reference lab processing patient blood specimens collected in an outpatient clinic, transplant center, or hospital prior to kidney transplantation.
Clinical & Coding Specifications
Clinical Context
A 52-year-old patient with end-stage kidney disease is evaluated prior to a planned deceased-donor kidney transplant. The transplant team orders a blood-based molecular risk assessment to estimate the patient’s probability of early acute rejection following transplantation. A peripheral blood specimen is drawn in the outpatient pre-transplant clinic or the hospital preoperative area and shipped to Verici Dx Inc. for the proprietary PreTransplant Risk Assessment (PTRA). The laboratory performs next-generation sequencing of targeted mRNA transcripts, applies the manufacturer’s algorithm, and returns a risk score to the transplant clinician. The result is used as one component of pretransplant immunologic risk stratification alongside HLA typing, donor-specific antibody testing, and clinical factors. Typical sites of service include outpatient transplant clinics, hospital preoperative testing areas, and reference laboratories. The service type is a proprietary laboratory analysis (PLA) using next-generation sequencing of transcriptome targets for immune-response gene expression profiling to estimate risk of early acute kidney transplant rejection.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier; standard reporting | Use when no additional modifier applies and the service is reported normally |
26 | Professional component | Use when reporting only the professional component if the laboratory separates technical and professional components and the lab provides interpretive service |
TC | Technical component | Use when reporting only the technical component when the performing laboratory bills separately for testing processes and materials |
52 | Reduced services | Use when testing is partially performed or an abbreviated version of the test is rendered with reduced resources |
53 | Discontinued procedure | Use when specimen collection or testing was started but discontinued for patient- or specimen-related reasons |
59 | Distinct procedural service | Data not available in the input. |
QK | Medical direction of qualified health care professionals | Use when a physician provides medical direction for a clinical laboratory service per CMS rules for supervision (if applicable) |
QX | Services performed by an assistant at surgery (assistant-at-surgery) | Use when an approved assistant participates in specimen collection in an operative setting (rare) |
QY | Qualified nonphysician practitioner | Use when a qualified nonphysician practitioner orders and oversees the specimen collection and associated services |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services for Medicare beneficiaries | Use when those practitioners perform or supervise the service for Medicare patients |
FY | Laboratory performed at distant site — technical component | Use when the technical component is performed at a distant or reference laboratory separate from the ordering facility |
QK | Data not available in the input. | Data not available in the input. |
QX | Data not available in the input. | Data not available in the input. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207L00000X | Transplant Surgeon | Performs transplant evaluation and coordinates pretransplant testing |
207X00000X | Nephrology | Manages kidney failure patients and interprets risk in renal transplant candidates |
208000000X | Pathology/Laboratory Medicine | Oversees laboratory testing, quality, and result interpretation in coordination with the test manufacturer |
363LF0000X | Clinical Laboratory | Laboratory professionals and directors responsible for performing the PLA and reporting results |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
| Data not available in the input. | Data not available in the input. | Data not available in the input. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0319U | PreTransplant Risk Assessment (PTRA) — Verici Dx Inc.; NGS-based transcriptome expression analysis producing a risk score for early acute kidney transplant rejection | Primary proprietary laboratory analysis code for this specific test |
36415 | Collection of venous blood by venipuncture | Commonly performed immediately prior to sending the specimen for the PTRA test |
84263 | Free/total PSA ratio; immunoassay (example of specialty lab assay code) | Data not available in the input. |
86140 | Antigen; bacterial, viral, or other organism antibody; immunoassay with direct optical observation | Used for companion immunologic testing such as donor-specific antibody screening in transplant evaluation |
88360 | Immunohistochemistry or immunocytochemistry, per single antigen stain | Data not available in the input. |