How To Use CPT Code 0037U

CPT 0037U describes a targeted genomic sequence analysis for solid organ neoplasms. This article will cover the official description, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples of CPT code 0037U.

1. What is CPT Code 0037U?

CPT 0037U can be used to describe a specific lab test called FoundationOne CDx™ (F1CDx®) test. This test is a companion diagnostic (CDx) test for five tumor indications, and it is performed by Foundation Medicine, Inc. The test analyzes the DNA of solid organ neoplasms 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 0037U is: ‘Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.’

3. Procedure

1. The lab analyst isolates DNA from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens.
2. Using hybridization-based capture, the analyst performs targeted genomic sequencing analysis on the DNA.
3. Next-generation sequencing technology and custom software are used to identify sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden in 324 genes.
4. A molecular pathologist reviews and interprets the identified mutations.

4. Qualifying circumstances

CPT 0037U is used for patients who may be candidates for specific targeted chemotherapies for cancers such as melanoma, non-small cell lung cancer, and breast, ovarian, and colorectal cancer. The test is performed on human specimens requested by the clinical lab offering the test.

5. When to use CPT code 0037U

CPT code 0037U should be used when ordering the FoundationOne CDx™ (F1CDx®) test for patients with solid organ neoplasms. It should not be reported with any other CPT code.

6. Documentation requirements

To support a claim for CPT code 0037U, the following documentation is required:

• Identification of the specific solid organ neoplasm being tested
• Date of service and the single specimen analyzed
• Details of the targeted genomic sequencing analysis performed
• Results and interpretation of the identified mutations

7. Billing guidelines

When billing for CPT code 0037U, ensure that the test is performed by Foundation Medicine, Inc. and that it is the only test reported. Do not report this test with any other CPT code. Use one unit of this code for a single specimen analyzed on a single date of service.

8. Historical information

CPT code 0037U was added to the Current Procedural Terminology system on April 1, 2018. There have been no updates to the code since its addition.

9. Examples

1. A patient with melanoma undergoes the FoundationOne CDx™ (F1CDx®) test to identify specific mutations that may guide targeted chemotherapy.
2. A patient with non-small cell lung cancer has the FoundationOne CDx™ (F1CDx®) test performed to determine the presence of gene rearrangements and copy number amplifications.
3. A patient with breast cancer undergoes the FoundationOne CDx™ (F1CDx®) test to assess microsatellite instability and tumor mutational burden.
4. A patient with ovarian cancer has the FoundationOne CDx™ (F1CDx®) test to identify sequence variants that may impact treatment options.
5. A patient with colorectal cancer undergoes the FoundationOne CDx™ (F1CDx®) test to determine the presence of specific gene mutations that may guide targeted therapies.