Summary & Overview
CPT 0389U: Kawasaki Disease RNA Expression Risk Score Test
CPT code 0389U is a Proprietary Laboratory Analyses (PLA) code assigned to the KawasakiDx, OncoOmicsDx Laboratory test from mProbe. The assay analyzes RNA expression of two genes in a patient blood specimen and produces a risk score to aid evaluation of Kawasaki disease (KD), an important cause of prolonged fever in children. As a PLA code, 0389U is specific to a single manufacturer’s test and is intended to support accurate reporting and tracking of novel laboratory diagnostics nationwide.
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 purpose of the test, the typical laboratory service setting, and the relevance of a PLA designation for payer policy and billing workflows. The publication outlines expected benchmarks for code adoption, considerations for coverage policy interpretation, and the clinical context in which the test may be ordered. Data not available in the input is noted where applicable, and the piece focuses on national implications rather than state-level specifics.
Billing Code Overview
CPT code 0389U is a Proprietary Laboratory Analyses (PLA) code for the KawasakiDx, OncoOmicsDx Laboratory test from mProbe. The test evaluates a patient blood specimen for RNA expression of two genes and reports a risk score for Kawasaki disease (KD), a cause of fever of unknown origin in children.
Service type: Proprietary laboratory molecular diagnostic assay (RNA expression test)
Typical site of service: Clinical laboratory or reference laboratory processing blood specimens
Clinical & Coding Specifications
Clinical Context
A pediatric patient aged 6 months to 5 years presents to an urgent care clinic or pediatric emergency department with persistent fever for more than 5 days, conjunctival injection, mucocutaneous changes, and possible lymphadenopathy. The clinician suspects Kawasaki disease (KD) as part of the differential for fever of unknown origin in a child. A peripheral blood specimen is ordered and sent to the laboratory performing the proprietary KawasakiDx, OncoOmicsDx assay from mProbe. The laboratory performs RNA expression analysis of the two genes specified by the proprietary test and returns a KD risk score. Results are reviewed by the ordering pediatrician or pediatric infectious disease specialist to inform risk stratification and further management, such as echocardiography referral, intravenous immunoglobulin consideration, or close outpatient follow-up.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default; no modifier | Use when no special circumstances apply to the laboratory service |
26 | Professional component | Use if a separate professional interpretation component is billed by a physician or pathologist for the test report |