Summary & Overview
CPT 0475U: Prostate Germline Panel (ProstateNow™)
Headline: New PLA CPT code 0475U identifies a single-manufacturer hereditary prostate cancer panel used to assess genetic risk. Lead: CPT code 0475U designates the ProstateNow™ Prostate Germline Panel from GoPath Diagnostics Inc., a proprietary 23-gene germline assay combining NGS, Sanger sequencing, MLPA, and array CGH to detect pathogenic variants and generate a prostate cancer genetic risk score. Why it matters: As a PLA code, 0475U is reportable only for this specific commercially distributed test, which affects coding accuracy, prior authorization workflows, and claims adjudication nationally.
Key payers covered: Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare are the primary payers referenced for national coverage and billing considerations.
What readers will learn: This publication explains the clinical purpose of the test, the laboratory service model and typical site of service, and the coding implications of a PLA-designated CPT code. It outlines expected assay methodologies and the nature of the reported result (including a genetic risk score), highlights factors that affect billing and claim processing for proprietary tests, and notes where data were not provided in the input (e.g., specific coverage policies, associated taxonomies, and ICD-10 diagnoses).
Billing Code Overview
CPT code 0475U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the ProstateNow™ Prostate Germline Panel from GoPath Diagnostics Inc. The test analyzes 23 genes related to hereditary prostate cancer–related disorders to detect pathologic germline mutations and structural alterations.
Service type: Genetic diagnostic testing using multiple molecular methods, including next-generation sequencing (NGS), Sanger sequencing, multiplex ligation–dependent probe amplification (MLPA), and array comparative genomic hybridization (CGH).
Typical site of service: Reference laboratory or specialized molecular diagnostics laboratory performing proprietary germline genetic testing. Any other service locations: Data not available in the input.
Clinical & Coding Specifications
Clinical Context
A 52-year-old man with a family history of prostate and related cancers is referred by his urologist for hereditary cancer risk assessment. He has a rising PSA trend and a first-degree relative diagnosed with early-onset prostate cancer. The clinician orders the ProstateNow™ Prostate Germline Panel (0475U) from GoPath Diagnostics Inc. to evaluate inherited variants across 23 genes that confer elevated prostate cancer risk. A typical workflow: the provider obtains informed consent and collects a peripheral blood or saliva sample in the clinic or specimen collection center; the sample is shipped to the performing laboratory; the laboratory performs next-generation sequencing, confirmatory Sanger sequencing as needed, and copy-number analysis using MLPA and array CGH; the lab issues a report including detected pathogenic or likely pathogenic variants and a genetic risk score for prostate cancer susceptibility; the ordering clinician reviews results with the patient, integrates findings into risk management and familial testing discussions, and documents results in the medical record.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Invalid or not used for reporting | Data not available in the input. |
22 | Increased procedural services | Use when work or resources for the test exceed typical expectations and payer allows modifier for PLA billing nuances.