Summary & Overview
CPT 0154U: FGFR3 RT‑PCR Assay for Urothelial Cancer
CPT code 0154U designates a proprietary laboratory analysis for the therascreen® FGFR RGQ RT–PCR Kit (QIAGEN), a real‑time RT‑PCR assay that detects FGFR3 gene abnormalities associated with urothelial cancer. As a PLA code, 0154U applies to a single manufacturer’s test and is used to identify and track utilization of this specific molecular diagnostic. Nationally, PLA codes like 0154U are important for monitoring adoption of targeted diagnostics and for informing coverage and payment discussions for precision oncology services.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication provides readers with payer coverage context, expected sites of service, and clinical application for FGFR3 testing in urothelial cancer. It outlines benchmarks for utilization reporting, common billing modifiers encountered, and the clinical rationale for ordering FGFR3 molecular testing in relevant tumor profiling and treatment selection.
Readers will learn: (1) the clinical purpose and laboratory setting for the test, (2) how PLA coding is used for proprietary assays, (3) payer landscape coverage considerations, and (4) where to find related billing and coding references. Data not available in the input are noted where applicable.
Billing Code Overview
CPT code 0154U is a Proprietary Laboratory Analyses (PLA) code for the therascreen® FGFR RGQ RT–PCR Kit from QIAGEN. The test uses real‑time reverse transcription PCR (real‑time RT‑PCR) to detect abnormalities in the fibroblast growth factor receptor 3 (FGFR3) gene that are known to be present in urothelial cancer.
Service Type: Proprietary molecular diagnostic assay (real‑time RT‑PCR) for FGFR3 alterations
Typical Site of Service: Clinical laboratory or specialized molecular diagnostics laboratory; samples collected in outpatient or hospital settings and sent to the performing lab
Clinical & Coding Specifications
Clinical Context
A 68-year-old patient with a history of hematuria and a prior diagnosis of non-muscle invasive urothelial carcinoma of the bladder presents for molecular testing of tumor tissue to evaluate for FGFR3 alterations. The treating urologist or oncologist orders the therascreen® FGFR RGQ RT–PCR Kit (0154U) performed by a commercial molecular pathology laboratory. The specimen is formalin-fixed paraffin-embedded (FFPE) tumor tissue or a validated urine or cytology sample collected during cystoscopy or at the time of tumor resection. The laboratory receives the specimen, verifies accessioning and patient identifiers, performs RNA extraction and real-time RT–PCR per the manufacturer’s instructions, interprets the assay results for FGFR3 mutations or fusions, and issues a molecular report to the ordering clinician. Results are used to guide eligibility for FGFR-targeted therapies, enrollment in clinical trials, or prognosis and surveillance planning.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing only the physician interpretation portion separate from the lab technical component, if applicable and permitted. |
52 | Reduced services | Use if the test is performed but in a reduced or limited manner documented in the record.