Summary & Overview
CPT 0367U: Oncuria Predict Urine Immunoassay for Bladder Cancer Recurrence Risk
CPT code 0367U designates Oncuria® Predict, a proprietary laboratory immunoassay and algorithmic test performed by DiaCarta Clinical Lab to assess 10 urinary protein biomarkers and report a risk score for rapid recurrence of recurrent or persistent bladder cancer after transurethral resection or biopsy. As a PLA CPT code, 0367U is uniquely tied to a single manufacturer's test and is used when that laboratory-specific assay is performed.
Nationally, proprietary molecular and protein-based diagnostics such as CPT code 0367U are increasingly relevant for personalized surveillance and risk stratification in oncology. Payers evaluated in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. These payers represent major commercial and federal coverage perspectives for diagnostic laboratory services.
Readers will find a concise overview of the clinical purpose and laboratory setting for the test, summaries of payer coverage considerations, and context on how PLA codes function within the CPT framework. The publication highlights what payers typically consider in coverage decisions for proprietary diagnostics — clinical validity, clinical utility, and test-specific evidence — and provides benchmarking and policy-update summaries where available. Data not available in the input will be noted explicitly in relevant sections.
Billing Code Overview
CPT code 0367U is a Proprietary Laboratory Analyses (PLA) code that describes a single, manufacturer-specific urine-based immunoassay: Oncuria® Predict performed by DiaCarta Clinical Lab, DiaCarta Inc. The test evaluates a urine specimen for levels of 10 protein biomarkers and applies an algorithmic analysis to generate a risk score for the likelihood of rapid recurrence of recurrent or persistent bladder cancer following transurethral resection or biopsy of a bladder tumor.
Service Type: Laboratory diagnostic test — proprietary urine immunoassay with algorithmic risk scoring
Typical Site of Service: Clinical laboratory or reference laboratory — outpatient specimen collection with laboratory-based analysis
Clinical & Coding Specifications
Clinical Context
A 68-year-old patient with a history of non-muscle invasive bladder cancer undergoes transurethral resection of bladder tumor (TURBT). Post-operatively the urologist needs risk stratification for early recurrence or persistence of disease to guide surveillance intensity and potential adjuvant intravesical therapy. A urine specimen is collected during the postoperative visit or at follow-up cystoscopy and sent to DiaCarta Clinical Lab for Oncuria® Predict testing (0367U). The laboratory performs an immunoassay measuring 10 protein biomarkers and applies a validated algorithm to generate a risk score for rapid recurrence following TURBT or biopsy. Results are reported to the ordering urologist and incorporated into clinical decision-making, such as scheduling earlier cystoscopic surveillance, considering repeat resection, or discussing additional therapies with the patient. Typical workflow steps: clinician orders the test in the electronic health record; urine specimen is collected, labeled, and shipped per DiaCarta instructions; DiaCarta performs the proprietary assay and algorithmic analysis; the lab issues a report with the risk score and interpretation to the ordering clinician; the clinician documents receipt of the report and adjusts follow-up plans accordingly. Typical site of service: outpatient urology clinic, ambulatory surgical center (specimen collected at follow-up), or clinical laboratory (testing performed by DiaCarta). Service type: proprietary laboratory analysis (PLA) — high-complexity diagnostic immunoassay with algorithmic risk-scoring performed by the specified manufacturer/lab.
Coding Specifications
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