0366U Oncuria Monitor CPT Reimbursement

CPT code 0366U defines a proprietary laboratory test — the Oncuria® Monitor from DiaCarta Inc. — that measures 10 urinary protein biomarkers by immunoassay and uses an algorithm to estimate the probability of bladder cancer recurrence in patients with prior disease. As a PLA code, 0366U represents a single manufacturer-specific assay and signals the growing role of multiplex biomarker testing and algorithmic interpretation in oncology surveillance. Nationally, such codes matter because they affect how novel diagnostics are billed, tracked, and reimbursed across public and private payers.

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 expected service setting, payer coverage patterns, and benchmarking elements relevant to lab-based oncology diagnostics. The publication also summarizes common billing modifiers and identifies where input data was not provided.

This report is intended to inform clinical laboratories, billing professionals, and policy analysts about the coding characteristics and payer landscape for a proprietary urine biomarker assay used in bladder cancer surveillance, and to provide context on how PLA codes fit into the broader diagnostic and reimbursement environment.

Billing Code Overview

CPT code 0366U is a Proprietary Laboratory Analyses (PLA) code specific to the Oncuria® Monitor from DiaCarta Clinical Lab, DiaCarta Inc. The test uses an immunoassay technique to measure levels of 10 protein biomarkers in a urine specimen and applies an algorithmic analysis to report the probability that a patient with prior bladder cancer has a recurrence.

Service type: Laboratory — proprietary urine biomarker assay with algorithmic interpretation

Typical site of service: Clinical laboratory or reference laboratory

Clinical Context

A 68-year-old male with a history of non–muscle-invasive bladder cancer (NMIBC) treated previously with transurethral resection of bladder tumor (TURBT) and intravesical therapy presents for routine surveillance. The urology team orders the Oncuria® Monitor urine test to aid in noninvasive detection of recurrent disease. A clean-catch or catheterized urine specimen is collected in the outpatient urology clinic or sent from a partnered ambulatory laboratory to DiaCarta Clinical Lab, DiaCarta Inc. The specimen undergoes an immunoassay panel measuring 10 protein biomarkers and an embedded algorithmic analysis. The laboratory reports a probability score indicating the likelihood of bladder cancer recurrence to the ordering provider. Results are reviewed during follow-up visits or telehealth encounters; a high-probability result may prompt cystoscopic evaluation, urine cytology, or imaging per the treating urologist’s clinical judgment.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier — standard reporting	Use when no additional modifier is required for routine reporting of the PLA test
`22`	Increased procedural services	Use when additional work beyond the typical laboratory processes is documented and billed (rare for PLA tests)

Taxonomy Code	Specialty	Notes
208800000X	Urology	Ordering and clinical interpretation by urologists managing bladder cancer surveillance
207L00000X	Pathology	Laboratory oversight, result validation, and diagnostic consultation
261QP2300X	Clinical Laboratory	Laboratory scientists and directors performing or overseeing the immunoassay testing
363LP0800X	Oncology	Medical oncologists ordering surveillance testing for patients with prior bladder cancer
282N00000X	Family Medicine	Primary care providers who may order the test for follow-up and coordination of care

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C67.9`	Malignant neoplasm of bladder, unspecified	Primary diagnosis for surveillance testing in patients with prior bladder cancer
`D09.0`	Carcinoma in situ of bladder	High-risk premalignant lesion monitored closely with urine tests and cystoscopy
`N13.6`	Pyonephrosis	Symptom overlap/urine abnormalities may confound urine-based testing; clinical correlation required
`R82.71`	Positive urine occult blood	Hematuria is a common presentation prompting bladder cancer surveillance and urine testing
`Z85.51`	Personal history of malignant neoplasm of bladder	Indicates surveillance status; supports medical necessity for recurrence monitoring

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0366U`	Oncuria® Monitor — immunoassay panel for 10 urinary protein biomarkers with algorithmic report for bladder cancer recurrence risk (Proprietary Laboratory Assay)	Primary test described; report this code when DiaCarta Clinical Lab performs the Oncuria® Monitor assay
`81000`	Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, specific gravity, etc., with microscopy not included	Commonly performed at specimen collection to screen urine quality and detect confounders prior to sending urine for PLA testing
`88112`	Cytopathology, urine or bladder washing, without concentration, except Papanicolaou - screening and interpretation	Urine cytology is often used alongside molecular or protein-based urine assays in surveillance for bladder cancer
`52000`	Cystourethroscopy (diagnostic) with or without collection of specimen(s) for culture and sensitivity	Diagnostic cystoscopy is often performed subsequently when noninvasive testing suggests a high probability of recurrence
`88305`	Surgical pathology, gross and microscopic examination, intermediate complexity	Used for analysis of tissue obtained at TURBT if cystoscopy or biopsy confirms lesion after positive noninvasive testing

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Summary & Overview

CPT 0366U: Oncuria® Monitor Urine Biomarker Assay for Bladder Cancer Recurrence