How To Use CPT Code 0154U
CPT 0154U refers to a proprietary laboratory analysis specifically designed for the detection of genetic alterations in the FGFR3 gene associated with urothelial cancer. This test utilizes real-time reverse transcription polymerase chain reaction (RT-PCR) technology to analyze RNA extracted from formalin-fixed paraffin-embedded tumor tissue. The results of this analysis provide critical information regarding the presence of specific mutations and fusions in the FGFR3 gene, which can influence treatment decisions for patients diagnosed with urothelial cancer.
1. What is CPT code 0154U?
CPT code 0154U represents a specialized laboratory test that analyzes the FGFR3 (fibroblast growth factor receptor 3) gene for mutations and fusions relevant to urothelial cancer. This test is performed using RNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue. The analysis identifies specific point mutations, such as p.R248C and p.S249C in exon 7, and p.G370C and p.Y373C in exon 10, as well as fusions like FGFR3-TACC3v1 and FGFR3-TACC3v3. The identification of these genetic alterations is crucial for determining whether a patient is a candidate for targeted therapies, such as Balversa™ (erdafitinib), which has shown efficacy in treating urothelial cancer with these specific FGFR3 mutations.
2. Qualifying Circumstances
This CPT code can be utilized specifically for the therascreen® FGFR RGQ RT–PCR Kit from QIAGEN, which is the only test that this code applies to. It is important to use this code only when the test is performed on a specimen derived from urothelial cancer tissue. The use of this code is appropriate when a clinician is assessing a patient with urothelial cancer to evaluate their eligibility for targeted therapy based on the presence of FGFR3 gene alterations. Inappropriate use of this code would include situations where the test is not performed on FFPE tumor tissue or when it is used for other types of cancer or genetic analyses not related to FGFR3.
3. When To Use CPT 0154U
CPT code 0154U should be used when a healthcare provider orders the specific FGFR3 gene analysis using the therascreen® FGFR RGQ RT–PCR Kit. This code is reported for a single specimen analyzed on a single date of service. It is essential to note that this code cannot be used in conjunction with other CPT codes for similar tests, as it is designated for this proprietary analysis only. If the provider performs preparatory work on the FFPE specimen prior to analysis, that work may be reported separately, provided it is documented appropriately.
4. Official Description of CPT 0154U
Official Descriptor: Oncology (urothelial cancer), RNA, analysis by real-time RT-PCR of the FGFR3 (fibroblast growth factor receptor 3) gene analysis (ie, p.R248C [c.742C>T], p.S249C [c.746C>G], p.G370C [c.1108G>T], p.Y373C [c.1118A>G], FGFR3-TACC3v1, and FGFR3-TACC3v3), utilizing formalin-fixed paraffin-embedded urothelial cancer tumor tissue, reported as FGFR gene alteration status.
5. Clinical Application
The clinical application of CPT code 0154U lies in its ability to provide vital genetic information for patients diagnosed with urothelial cancer. By identifying specific mutations and fusions in the FGFR3 gene, healthcare providers can make informed decisions regarding the most effective treatment options available. The presence of these genetic alterations can indicate a patient’s potential response to targeted therapies, such as Balversa™, which is specifically designed to treat urothelial cancer with FGFR3 mutations. This test is particularly important in the context of personalized medicine, where treatment plans are tailored to the genetic profile of the tumor.
5.1 Provider Responsibilities
During the procedure, the provider is responsible for several key actions. First, they must obtain a sample of formalin-fixed paraffin-embedded tumor tissue from the patient. This sample is then processed to extract RNA, which is crucial for the subsequent analysis. The provider must ensure that the sample is prepared correctly, which involves manual sample preparation followed by reverse transcription to convert RNA into complementary DNA (cDNA). After preparation, the sample undergoes automated amplification and detection using the proprietary Rotor-Gene Q MDx instrument. Finally, the provider interprets the results, which report the FGFR gene alteration status, and communicates these findings to the patient and other members of the healthcare team.
5.2 Unique Challenges
One of the unique challenges associated with this service is the need for precise handling and processing of the FFPE tumor tissue samples. The quality of the RNA extracted can significantly impact the accuracy of the test results. Additionally, the provider must be well-versed in the specific mutations and fusions being analyzed, as well as their clinical implications. There may also be logistical challenges in coordinating the testing process, including ensuring timely specimen collection and processing, as well as managing patient expectations regarding the results and their potential impact on treatment options.
5.3 Pre-Procedure Preparations
Before the procedure, the provider must conduct a thorough evaluation of the patient’s medical history and confirm the diagnosis of urothelial cancer. This may involve imaging studies or biopsies to obtain the necessary tumor tissue. The provider must also ensure that the specimen is properly preserved and transported to the laboratory for analysis. Adequate documentation of the specimen source and any preparatory work performed is essential for accurate reporting and billing.
5.4 Post-Procedure Considerations
After the procedure, the provider must monitor the patient for any potential complications related to the biopsy or tissue collection. Once the test results are available, the provider should discuss the findings with the patient, explaining the significance of any identified FGFR3 gene alterations. This discussion should include potential treatment options, including the possibility of targeted therapies like Balversa™, and the implications for the patient’s overall treatment plan. Follow-up appointments may be necessary to reassess the patient’s condition and response to any initiated therapies.
6. Relevant Terminology
Amplification: The process of making multiple copies of a specific DNA or RNA sequence for analysis, often using techniques such as polymerase chain reaction (PCR).
Gene: A segment of DNA that contains the instructions for producing a specific protein or performing a particular function in the body.
Genomic sequencing procedure: A laboratory technique that determines the order of nucleotides in a DNA molecule, allowing for the identification of genetic variants.
Multianalyte assays with algorithmic analyses (MAAA): A set of laboratory tests that analyze multiple biomarkers and use algorithms to interpret the results, often used in cancer diagnostics.
Mutation: A change in the DNA sequence that can lead to alterations in gene function and may contribute to disease.
Polymerase chain reaction (PCR): A widely used laboratory technique for amplifying specific DNA or RNA sequences, enabling detailed study of genetic material.
7. Clinical Examples
1. A patient diagnosed with urothelial cancer undergoes a biopsy, and the tissue sample is sent for FGFR3 gene analysis to determine eligibility for targeted therapy.
2. A clinician orders the FGFR3 analysis after identifying specific symptoms in a patient that suggest advanced urothelial cancer.
3. Following the identification of FGFR3 mutations in a patient’s tumor, the healthcare team discusses the potential benefits of Balversa™ as a treatment option.
4. A laboratory technician prepares FFPE tumor samples for RNA extraction, ensuring that the integrity of the sample is maintained throughout the process.
5. A patient receives counseling regarding the implications of their FGFR3 gene alteration status and how it may affect their treatment plan.
6. A healthcare provider reviews the results of the FGFR3 analysis and collaborates with an oncologist to develop a personalized treatment strategy.
7. A follow-up appointment is scheduled for a patient to monitor their response to Balversa™ after starting treatment based on their FGFR3 mutation status.
8. A patient expresses concerns about the side effects of targeted therapy, prompting a discussion about the benefits and risks associated with their specific FGFR3 alterations.
9. A research study is initiated to evaluate the long-term outcomes of patients with urothelial cancer who have FGFR3 mutations treated with Balversa™.
10. A healthcare provider documents the patient’s history and the results of the FGFR3 analysis in their medical record to ensure continuity of care.
