2025 CPT code 0154U
Effective Date: N/A Revision Date: N/A Proprietary Laboratory Analyses Feed
Oncology (urothelial cancer), RNA analysis by real-time RT-PCR of the FGFR3 gene for specific mutations, using formalin-fixed paraffin-embedded urothelial cancer tumor tissue, reported as FGFR gene alteration status.
Modifiers may be applicable depending on the specific payer and clinical scenario. Consult payer guidelines for appropriate modifier usage.
Medical necessity is established by the patient having a diagnosis of urothelial cancer, and the results of this test will impact treatment decisions, specifically determining eligibility for erdafitinib or other targeted therapies based on FGFR3 gene status.
The ordering clinician is responsible for determining the appropriateness of the test for the individual patient based on their clinical presentation and treatment plan. The laboratory performing the test is responsible for accurate and timely processing and reporting of results.
In simple words: This test looks for specific changes in a gene called FGFR3, which can be found in bladder cancer. It helps doctors decide if a medicine called Balversa™ might be a good treatment option.
This test uses real-time reverse transcription PCR (real-time RT-PCR) to detect specific abnormalities in the fibroblast growth factor receptor 3 (FGFR3) gene found in urothelial cancer. RNA samples are taken from formalin-fixed paraffin-embedded tumor tissue from the urothelial lining of the urinary tract. The test identifies two point mutations (p.R248C, p.S249C) in exon 7, two point mutations (p.G370C, p.Y373C) in exon 10, and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the FGFR3 gene. The report indicates the alteration status for these mutations, which are present in some patients with urothelial cancer. This information helps clinicians determine if patients are suitable candidates for targeted therapies like Balversa™ (erdafitinib).
Example 1: A patient with newly diagnosed urothelial cancer undergoes biopsy. The tissue sample is sent for FGFR3 analysis using code 0154U to assess eligibility for erdafitinib therapy., A patient with advanced urothelial cancer that has progressed despite prior chemotherapy undergoes a repeat biopsy. The tissue sample is sent for FGFR3 analysis using code 0154U to guide treatment decisions., A patient with recurrent urothelial cancer undergoes a surveillance cystoscopy with biopsy. The tissue is sent for FGFR3 analysis via 0154U to assess eligibility for targeted therapies in case of recurrence.
Documentation should include the diagnosis of urothelial cancer, the reason for the test, the tissue sample source, and a signed order from the treating physician.
- Specialties:Oncology, Urology, Pathology
- Place of Service:Independent Laboratory, Hospital Inpatient, Hospital Outpatient, and potentially other places of service where molecular diagnostics are performed.