CPT 0465U: UriFind methylation assay for bladder cancer risk

Headline: New CPT code 0465U identifies a proprietary methylation assay tied to bladder cancer risk

Lead: CPT code 0465U designates the UriFind® proprietary laboratory assay, a molecular test that detects methylation of the ONECUT2 and VIM DNA markers to stratify bladder cancer risk. The code matters nationally because it standardizes billing and reporting for a single-manufacturer diagnostic that can influence diagnostic pathways for patients evaluated for bladder cancer.

What the code represents and why it matters: CPT code 0465U applies exclusively to the UriFind® cancer assay from DiaCarta Inc. and AnchorDx. It captures a lab-performed molecular diagnostic that yields a binary result—positive or negative—based on methylation status of two markers associated with bladder cancer. Standardized coding supports claims processing, utilization tracking, and comparative evaluation of molecular diagnostics across payers.

Key payers covered: Analysis includes national payers: Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.

What readers will learn: The publication provides clinical context for the assay, national payer coverage framing, coding and reporting considerations for a PLA code, and what to expect in terms of service setting and use cases. Data not available in the input is identified where applicable, and readers will find concise guidance on the code's scope and implications for laboratory billing and diagnostic workflows.

Billing Code Overview

CPT code 0465U is a Proprietary Laboratory Analyses (PLA) code reported only for the UriFind® cancer assay manufactured by DiaCarta Inc. and AnchorDx. The test analyzes a patient sample to detect DNA methylation changes in two specific markers, ONECUT2 and VIM, and reports a positive or negative result. A positive result indicates the presence of these methylation markers and suggests a high risk of bladder cancer.

Service type: Molecular diagnostic laboratory test (proprietary methylation assay)
Typical site of service: Clinical laboratory or specialty diagnostic laboratory processing patient specimens

Clinical Context

A 65-year-old patient with a history of smoking presents to urology with intermittent painless hematuria and urinary frequency. The urologist collects a voided urine specimen or orders a urine-based molecular test to evaluate for bladder cancer. The clinician orders the UriFind® cancer assay (0465U) to detect methylation of ONECUT2 and VIM genes. The specimen is sent to DiaCarta Inc. or AnchorDx laboratory. The lab performs DNA extraction and methylation-specific analysis, then reports a binary result: positive (methylation detected; high risk for bladder cancer) or negative (methylation not detected; lower risk). Results are reviewed by the ordering urologist who integrates findings with cystoscopy, urine cytology, imaging, and clinical history to guide surveillance, diagnostic cystoscopy, biopsy, or continued monitoring.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier	Standard reporting when no modifier applies to the service
`26`

Taxonomy Code	Specialty	Notes
207RH0000X	Urology	Ordering clinicians who evaluate hematuria and manage bladder cancer diagnostics
207K00000X	Pathology	Pathologists who may review and interpret molecular test results; professional component billing if applicable
208000000X	Diagnostic Laboratory	Clinical laboratory scientists and molecular diagnostic labs performing the assay
2084P0800X	Molecular Genetic Laboratory	Labs specializing in methylation and DNA-based assays
363LA2200X	Clinical Cytogenetics	Specialists involved in genetic test validation and oversight

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`R31.9`	Hematuria, unspecified	Common presentation prompting urine-based bladder cancer testing
`R33.9`	Urinary retention, unspecified	Urinary symptoms that may trigger urologic workup including urine assays
`N39.0`	Urinary tract infection, site not specified	Infection must be considered and sometimes excluded before molecular cancer testing
`C67.9`	Malignant neoplasm of bladder, unspecified	Primary diagnosis of interest when assessing for bladder cancer risk with the assay
`Z85.51`	Personal history of bladder cancer	Surveillance testing in patients with prior bladder cancer to monitor for recurrence

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0436U`	Urine bladder cancer methylation assay, other proprietary test	Alternative urine methylation assay that may be ordered instead of or alongside `0465U`
`80500`	Drug assay by immunoassay; qualitative or semiquantitative, per drug class	Not specific to methylation testing; relevant as an example of urine-based laboratory testing workflows
`81025`	Urine pregnancy test, by device; non-automated, with cassette	Example of point-of-care urine testing that may occur during urology visits prior to molecular testing
`88342`	Immunohistochemistry or in-situ hybridization interpretation	Performed on tissue biopsy specimens obtained after a positive urine molecular test to confirm malignancy
`88305`	Level IV surgical pathology, gross and microscopic examination	Pathology code used for transurethral resection or bladder biopsy specimens obtained following positive urine assay

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Summary & Overview