Summary & Overview

CPT 0497U: OncoAssure Prostate RT‑PCR Gene Expression Risk Score

CPT code 0497U designates a Proprietary Laboratory Analyses (PLA) test for OncoAssure™ Prostate (DiaCarta Inc.), a commercially developed molecular diagnostic that uses RT–PCR to quantify mRNA expression of six genes in FFPE prostate tissue and report a prostate cancer risk score. As a PLA code, 0497U is specific to a single manufacturer's test and is intended to identify and track utilization of this proprietary assay nationally.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a national overview of the code’s clinical context, common site-of-service usage, and how the code is positioned for coverage and billing considerations across major payers. The publication summarizes benchmark elements such as typical service settings, payer recognition patterns, and policy implications for PLA-coded molecular diagnostics.

The article provides practical reference material for coding, reimbursement staff, laboratory administrators, and clinical teams seeking concise information on what 0497U represents, where the service is typically performed, and which major payers are relevant. Data not available in the input will be explicitly noted where applicable in subsequent sections.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0497UCPTProprietary Laboratory Analysesmolecular diagnosticsRT-PCRprostate cancerFFPEgene expressionlaboratory testing

Billing Code Overview

CPT code 0497U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the OncoAssure™ Prostate test from DiaCarta Inc. The test uses real–time reverse transcription polymerase chain reaction (RT–PCR) to measure mRNA expression of six genes in formalin–fixed paraffin–embedded (FFPE) prostate tissue and generates a risk score for prostate cancer.

Service type: Laboratory molecular diagnostic test using RT–PCR to derive a gene-expression–based risk score
Typical site of service: Clinical laboratory performing PLA testing on FFPE prostate tissue; specimens are sourced from outpatient urology or pathology settings

Clinical & Coding Specifications

Clinical Context

A 66-year-old man with a previously diagnosed localized prostate adenocarcinoma is being considered for active surveillance versus definitive therapy. Prostate needle biopsy tissue fixed in formalin and embedded in paraffin (FFPE) is submitted to the molecular diagnostics laboratory. The OncoAssure™ Prostate assay (0497U) uses real-time RT-PCR to measure mRNA expression of six genes and generates a risk score to inform prognosis and guide management decisions (for example, supporting active surveillance or recommending treatment escalation).

Workflow:

The urologist documents clinical indication (e.g., newly diagnosed prostate cancer, rising PSA, or consideration of surveillance) and requests the OncoAssure™ Prostate test.
The pathology department retrieves representative FFPE prostate biopsy blocks or slides and performs any required microdissection and nucleic acid extraction per the test kit/lab protocol.
The reference laboratory performs real-time RT-PCR analysis of the six-gene panel and generates the OncoAssure risk score and report.
The laboratory issues a final report to the ordering urologist, and the urologist incorporates the result into shared decision-making about surveillance versus definitive therapy.

Typical site of service: outpatient hospital laboratory, independent clinical diagnostic laboratory, or pathology department associated with an ambulatory surgery center or hospital outpatient setting.

Typical patient scenario: men with biopsy-proven, clinically localized prostate adenocarcinoma (e.g., Grade Group 1–2) seeking molecular risk stratification to inform management choices.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when billing only the professional component of a laboratory test if separated from technical component billing (rare for PLAs billed by the performing lab).
`52`	Reduced services	Use when the test is partially performed or a reduced version of the service is provided.
`53`	Discontinued procedure	Use if testing was started but discontinued for unavoidable clinical reasons.
`62`	Two surgeons	Use when two qualified surgeons or proceduralists share responsibility for a procedure related to tissue procurement (e.g., complex biopsy) that led to the specimen for testing.
`78`	Unplanned return to the OR following initial procedure	Use when an unplanned reoperation related to specimen procurement occurs and affects billing context.
`80`	Assistant surgeon	Use when an assistant surgeon participated in obtaining the surgical specimen that is relevant to billing context.
`82`	Assistant surgeon (when qualified resident not available)	Use similarly when an assistant surgeon is used instead of a resident.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist services in place of physician	Use when a physician assistant or advanced practice clinician provided services relevant to specimen collection under appropriate rules.
`QK`	Medical direction of two, three or four clinical staff services	Use when the ordering provider medically directs clinical staff involved in specimen handling in qualified circumstances.
`QX`	Modifier for modifierQX - assistant-at-surgery	Use when appropriate for workforce rules where assistant documentation is required.
`QY`	Medical direction of one qualified health care professional by a physician	Use when physician supervises a single qualified health care professional involved in specimen acquisition.
`TC`	Technical component	Use to indicate the technical component of a laboratory service when billing is split and the performing lab bills the technical component.
`26`	Professional component	Included above; when both components are reported separately use `26` for professional component.
`GY`	Not listed in provided list — Data not available in the input.	Data not available in the input.

Taxonomy Code	Specialty	Notes
`208800000X`	Urology	Urologists commonly order and interpret prostate molecular diagnostic tests.
`208000000X`	Pathology	Anatomical and clinical pathologists handle FFPE tissue processing and coordination with molecular labs.
`334000000X`	Clinical Laboratory	Clinical laboratory directors and molecular genetic pathologists oversee RT-PCR testing and result validation.
`363L00000X`	Nurse Practitioner	Advanced practice clinicians in urology clinics frequently coordinate testing and patient counseling.
`207R00000X`	Radiation Oncology	Radiation oncologists may use molecular risk stratification information when considering local therapy.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C61`	Malignant neoplasm of prostate	Primary diagnosis for which OncoAssure™ Prostate molecular risk stratification is used to guide management.
`N40.0`	Benign prostatic hyperplasia with lower urinary tract symptoms	Used when prostate pathology exists and molecular testing may be considered if cancer suspicion remains, though less common.
`R97.20`	Elevated prostate specific antigen [PSA], unspecified	Elevated PSA often triggers biopsy and subsequent molecular testing on prostate tissue.
`R97.21`	Rising PSA following treatment	Used when assessing recurrence risk and considering molecular characterization in certain clinical contexts.
`Z85.46`	Personal history of malignant neoplasm of prostate	Relevant when assessing recurrence risk or surveillance strategy and deciding on molecular testing to inform ongoing management.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`88305`	Level IV surgical pathology, gross and microscopic examination	Performed by pathology to evaluate prostate biopsy tissue before molecular testing and to select appropriate tumor-rich blocks for OncoAssure™ processing.
`88342`	Immunohistochemistry, per single antibody stain	May be performed on FFPE tissue to characterize tumor markers complementary to molecular risk assays.
`0000U`	Example PLA code placeholder — Data not available in the input.	Data not available in the input.
`81210`	BRCA1; full sequence analysis (example hereditary panel) — Not specific to prostate PLA but represents molecular testing workflows	Molecular laboratory workflows and billing practices for PCR/sequencing tests parallel those for PLA assays.
`J9999`	Unlisted drug/biologic code — Data not available in the input.	Data not available in the input.

Note: Related CPT codes selected represent ancillary pathology and molecular diagnostics typically performed before or alongside a PLA test such as 0497U.