Summary & Overview
CPT 0155U: PIK3CA PCR Kit for Breast Tumor Mutation Detection
CPT code 0155U designates a Proprietary Laboratory Analyses (PLA) molecular test — the therascreen® PIK3CA RGQ PCR Kit from QIAGEN — for detecting 11 PIK3CA mutations in breast tumor tissue. As a PLA code, 0155U applies uniquely to this specific manufacturer’s assay, which is used in oncologic molecular profiling to inform targeted treatment decisions for patients with breast cancer.
Key national payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical context for PIK3CA testing, the coding and billing implications of a PLA CPT code, and what to expect from payer coverage patterns at a high level.
The publication provides benchmarks and policy-relevant details: an explanation of how PLA codes differ from general molecular CPT codes, typical sites of service and specimen types for billing, and common payer considerations for proprietary tests. It also outlines areas where data was not available in the input, such as specific payer policy language, reimbursement amounts, associated taxonomies, and ICD-10 mappings. The goal is to give clinicians, lab managers, and billing professionals a clear, national-level briefing on CPT code 0155U and its role in breast cancer molecular diagnostics.
Billing Code Overview
CPT code 0155U is a Proprietary Laboratory Analyses (PLA) code for the therascreen® PIK3CA RGQ PCR Kit from QIAGEN. The test is a real‑time quantitative PCR assay designed to detect 11 mutations in the phosphatidylinositol 3‑kinase catalytic subunit alpha (PIK3CA) gene in breast tumor tissue.
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Service type: Molecular diagnostic testing for PIK3CA mutation detection in tumor tissue
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Typical site of service: Clinical laboratory or pathology laboratory processing breast tumor tissue specimens
Data not available in the input.
Clinical & Coding Specifications
Clinical Context
A 58-year-old woman with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer undergoes tumor genotyping to evaluate eligibility for targeted therapy directed at PIK3CA mutations. A formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue block or unstained slides are submitted to the laboratory. The laboratory performs the therascreen® PIK3CA RGQ PCR Kit (report with CPT 0155U) to detect 11 activating PIK3CA mutations using real-time quantitative PCR. Results are returned to the treating oncologist and incorporated into therapeutic decision-making, such as consideration of PI3K inhibitors when a qualifying mutation is detected.
Workflow steps:
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Ordering: Oncologist orders tumor PIK3CA testing and records clinical indication and specimen type.
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Specimen collection and transport: Surgical pathology identifies and prepares FFPE tissue block or unstained slides and ships with appropriate documentation to the performing laboratory.
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Laboratory analysis: Molecular pathology performs extraction, PCR-based assay using the therascreen PIK3CA RGQ PCR Kit, interprets results, and issues a report noting detected mutations and assay limitations.
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Reporting and clinical use: Results are posted in the medical record and used by the oncology team to inform systemic therapy selection and eligibility for targeted agents or clinical trials.
Coding Specifications
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