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.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0367UCPTProprietary Laboratory AnalysisUrine ImmunoassayBladder CancerRisk ScoreDiagnostic LaboratoryOncology DiagnosticsAlgorithmic Test

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

Modifier	Description	When to Use
`00`	No modifier; standard reporting	Use as the default when no special circumstances apply.
`26`	Professional component	Use when reporting only the physician/professional interpretation component if applicable (rare for PLA tests).
`TC`	Technical component	Use when reporting only the technical component; labs typically report the TC when billing the testing facility portion.
`QK`	CLIA waived test performed at point of care	Not typically used for PLA `0367U` but included when point-of-care waived testing applies.
`QX`	Ordering physician attestation for CLIA-waived testing performed by non-physician	Not routine for this PLA; included for completeness when delegation applies.
`QY`	Laboratory performing provider-performed microscopy under CLIA	Generally not applicable to `0367U`; include if specific lab billing rules require it.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist services	Use when these clinicians order or manage the test under incident-to rules per payer guidance.
`62`	Two surgeons	Rare for laboratory tests; use only when two surgeons are legitimately billing related procedural services.
`22`	Increased procedural services	Use when unusually high complexity or extra work is documented related to management prompted by test results.
`52`	Reduced services	Use if the service was partially reduced or not completed as documented.
`53`	Discontinued procedure	Use if the specimen collection or related procedure was started but discontinued for documented reasons.
`78`	Unplanned return to operating/procedure room	Use if test-related procedures precipitate an unplanned return to OR and billing of related services is required.
`80`	Assistant at surgery	Use if an assistant bills for surgical services directly related to procedures tied to the diagnostic workflow.
`62`	Two surgeons	Use in exceptionally rare cases when two surgeons share billing for procedural work associated with the patient’s care.

Taxonomy Code	Specialty	Notes
208800000X	Urology	Ordering specialty most commonly responsible for `0367U` testing and post-TURBT management.
207Q00000X	Pathology	Pathology/laboratory medicine oversight for specimen handling, test validation, and interpretation support.
261QM0800X	Clinical Laboratory Scientist	Laboratory professionals performing or overseeing the PLA testing and quality control.
363L00000X	Oncology	Medical oncology may order or use the risk score for adjuvant therapy planning in recurrent bladder cancer.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C67.0`	Malignant neoplasm of trigone of bladder	Primary bladder cancer site; test used for recurrence risk after TURBT/biopsy.
`C67.1`	Malignant neoplasm of dome of bladder	Bladder cancer diagnosis relevant to surveillance and recurrence risk assessment.
`C67.2`	Malignant neoplasm of lateral wall of bladder	Common site of bladder tumors; test helps predict rapid recurrence or persistence.
`C67.3`	Malignant neoplasm of anterior wall of bladder	Site-specific bladder cancer code used in post-resection monitoring with `0367U`.
`C67.4`	Malignant neoplasm of posterior wall of bladder	Bladder cancer location relevant to post-TURBT surveillance strategy.
`C67.5`	Malignant neoplasm of bladder neck	Tumor location associated with recurrence risk assessment via Oncuria® Predict.
`C67.6`	Malignant neoplasm of ureteric orifice	Involvement of ureteric orifice influences clinical surveillance and relevance of urine-based assays.
`C67.9`	Malignant neoplasm of bladder, unspecified	Used when bladder cancer site is unspecified; appropriate for ordering `0367U` to assess recurrence risk.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`52000`	Cystourethroscopy, diagnostic, with or without collection of specimen(s) by brushing or washing	Diagnostic cystoscopy often performed before or at the time of urine collection for `0367U` risk assessment.
`52224`	Cystourethroscopy, with removal of foreign body; opening or biopsy of bladder tumor; transurethral resection of bladder tumor (TURBT), single or multiple, including fulguration when performed	TURBT is the index procedure after which `0367U` predicts rapid recurrence or persistence; results inform further management.
`88112`	Flow cytometry, each additional marker (List separately in addition to code for primary flow cytometry)	Ancillary laboratory tests such as urine cytology or flow cytometry may be ordered alongside `0367U` for comprehensive surveillance.
`88108`	Cytopathology, smears, breast, thyroid, or other; single cell type or concentrated specimen	Urine cytology codes are used for cytologic evaluation of urine specimens often performed in the same surveillance episode.
`88305`	Pathology and Laboratory — Surgical pathology, gross and microscopic examination	Pathology services for TURBT specimens are part of the diagnostic workflow that complements the molecular PLA risk assessment.

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Summary & Overview

CPT 0367U: Oncuria Predict Urine Immunoassay for Bladder Cancer Recurrence Risk

Billing Code Overview

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

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier; standard reporting	Use as the default when no special circumstances apply.
`26`	Professional component	Use when reporting only the physician/professional interpretation component if applicable (rare for PLA tests).
`TC`	Technical component	Use when reporting only the technical component; labs typically report the TC when billing the testing facility portion.
`QK`	CLIA waived test performed at point of care	Not typically used for PLA `0367U` but included when point-of-care waived testing applies.
`QX`	Ordering physician attestation for CLIA-waived testing performed by non-physician	Not routine for this PLA; included for completeness when delegation applies.
`QY`	Laboratory performing provider-performed microscopy under CLIA	Generally not applicable to `0367U`; include if specific lab billing rules require it.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist services	Use when these clinicians order or manage the test under incident-to rules per payer guidance.
`62`	Two surgeons	Rare for laboratory tests; use only when two surgeons are legitimately billing related procedural services.
`22`	Increased procedural services	Use when unusually high complexity or extra work is documented related to management prompted by test results.
`52`	Reduced services	Use if the service was partially reduced or not completed as documented.
`53`	Discontinued procedure	Use if the specimen collection or related procedure was started but discontinued for documented reasons.
`78`	Unplanned return to operating/procedure room	Use if test-related procedures precipitate an unplanned return to OR and billing of related services is required.
`80`	Assistant at surgery	Use if an assistant bills for surgical services directly related to procedures tied to the diagnostic workflow.
`62`	Two surgeons	Use in exceptionally rare cases when two surgeons share billing for procedural work associated with the patient’s care.

Taxonomy Code	Specialty	Notes
208800000X	Urology	Ordering specialty most commonly responsible for `0367U` testing and post-TURBT management.
207Q00000X	Pathology	Pathology/laboratory medicine oversight for specimen handling, test validation, and interpretation support.
261QM0800X	Clinical Laboratory Scientist	Laboratory professionals performing or overseeing the PLA testing and quality control.
363L00000X	Oncology	Medical oncology may order or use the risk score for adjuvant therapy planning in recurrent bladder cancer.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C67.0`	Malignant neoplasm of trigone of bladder	Primary bladder cancer site; test used for recurrence risk after TURBT/biopsy.
`C67.1`	Malignant neoplasm of dome of bladder	Bladder cancer diagnosis relevant to surveillance and recurrence risk assessment.
`C67.2`	Malignant neoplasm of lateral wall of bladder	Common site of bladder tumors; test helps predict rapid recurrence or persistence.
`C67.3`	Malignant neoplasm of anterior wall of bladder	Site-specific bladder cancer code used in post-resection monitoring with `0367U`.
`C67.4`	Malignant neoplasm of posterior wall of bladder	Bladder cancer location relevant to post-TURBT surveillance strategy.
`C67.5`	Malignant neoplasm of bladder neck	Tumor location associated with recurrence risk assessment via Oncuria® Predict.
`C67.6`	Malignant neoplasm of ureteric orifice	Involvement of ureteric orifice influences clinical surveillance and relevance of urine-based assays.
`C67.9`	Malignant neoplasm of bladder, unspecified	Used when bladder cancer site is unspecified; appropriate for ordering `0367U` to assess recurrence risk.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`52000`	Cystourethroscopy, diagnostic, with or without collection of specimen(s) by brushing or washing	Diagnostic cystoscopy often performed before or at the time of urine collection for `0367U` risk assessment.
`52224`	Cystourethroscopy, with removal of foreign body; opening or biopsy of bladder tumor; transurethral resection of bladder tumor (TURBT), single or multiple, including fulguration when performed	TURBT is the index procedure after which `0367U` predicts rapid recurrence or persistence; results inform further management.
`88112`	Flow cytometry, each additional marker (List separately in addition to code for primary flow cytometry)	Ancillary laboratory tests such as urine cytology or flow cytometry may be ordered alongside `0367U` for comprehensive surveillance.
`88108`	Cytopathology, smears, breast, thyroid, or other; single cell type or concentrated specimen	Urine cytology codes are used for cytologic evaluation of urine specimens often performed in the same surveillance episode.
`88305`	Pathology and Laboratory — Surgical pathology, gross and microscopic examination	Pathology services for TURBT specimens are part of the diagnostic workflow that complements the molecular PLA risk assessment.