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.
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.
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Service type: Laboratory molecular diagnostic test using RT–PCR to derive a gene-expression–based risk score
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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:
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The urologist documents clinical indication (e.g., newly diagnosed prostate cancer, rising PSA, or consideration of surveillance) and requests the OncoAssure™ Prostate test.
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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.
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The reference laboratory performs real-time RT-PCR analysis of the six-gene panel and generates the OncoAssure risk score and report.
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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.