How To Use CPT Code 0334U

CPT 0334U describes the targeted genomic sequence analysis for solid organ oncology using formalin-fixed paraffin-embedded (FFPE) tumor tissue. This article will cover the description, official description, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples.

1. What is CPT Code 0334U?

CPT 0334U can be used to describe the targeted genomic sequence analysis for solid organ oncology using formalin-fixed paraffin-embedded (FFPE) tumor tissue. This code is used when analyzing 84 or more genes in the DNA of the tumor tissue to identify sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.

2. Official Description

The official description of CPT code 0334U is: ‘Oncology (solid organ), targeted genomic sequence analysis, formalin-fixed paraffin-embedded (FFPE) tumor tissue, DNA analysis, 84 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.’

3. Procedure

1. The analyst evaluates formalin-fixed paraffin-embedded (FFPE) solid tumor tissue using next-generation sequencing (NGS) targeted gene panel.
2. The NGS instrument determines the order of DNA nucleotides in many genes and uses bioinformatics to interpret the results.
3. The digital sequence library from the specimen is compared to a comprehensive panel of 84 or more solid organ cancer-related genes.
4. The analysis detects sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.

4. Qualifying circumstances

CPT 0334U is used for patients with solid organ tumors who undergo tissue biopsy. The test focuses on genomic changes associated with actionable FDA-approved treatments or late-phase clinical trials to inform treatment selection and improve patient outcomes.

5. When to use CPT code 0334U

CPT code 0334U should be used when analyzing formalin-fixed paraffin-embedded (FFPE) solid tumor tissue for targeted genomic sequence analysis. It is appropriate for patients with solid organ tumors who require genetic analysis to guide treatment decisions.

6. Documentation requirements

To support a claim for CPT code 0334U, the following documentation is required:

• Confirmation of tissue biopsy and the specific solid organ tumor
• Details of the next-generation sequencing (NGS) targeted gene panel used
• Date of service and the start and end time of the analysis
• Results of the analysis, including sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden
• Signature of the analyst performing the analysis

7. Billing guidelines

When billing for CPT code 0334U, ensure that the analysis is performed using formalin-fixed paraffin-embedded (FFPE) tumor tissue and includes the analysis of 84 or more genes. This code should be reported for each individual specimen analyzed on a single date of service. Do not report CPT code 0334U for any other test or use any other CPT code to report this specific analysis.

8. Historical information

CPT code 0334U was added to the Current Procedural Terminology system on October 1, 2022. There have been no updates or changes to the code since its addition.

9. Examples

1. An analyst performs targeted genomic sequence analysis on formalin-fixed paraffin-embedded (FFPE) tumor tissue from a patient with lung cancer, analyzing 84 or more genes to identify sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.
2. Using next-generation sequencing (NGS), an analyst analyzes formalin-fixed paraffin-embedded (FFPE) tumor tissue from a patient with breast cancer, evaluating 84 or more genes for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.
3. Targeted genomic sequence analysis is performed on formalin-fixed paraffin-embedded (FFPE) tumor tissue from a patient with colorectal cancer, examining 84 or more genes for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.
4. An analyst analyzes formalin-fixed paraffin-embedded (FFPE) tumor tissue from a patient with melanoma, evaluating 84 or more genes using next-generation sequencing (NGS) to identify sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.
5. Using formalin-fixed paraffin-embedded (FFPE) tumor tissue, an analyst performs targeted genomic sequence analysis on 84 or more genes from a patient with genitourinary tract cancer, identifying sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.