How To Use CPT Code 0326U

CPT 0326U describes the targeted genomic sequence analysis panel for solid organ neoplasms using cell-free circulating DNA analysis of 83 or more genes. This article will cover the description, official details, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples.

1. What is CPT Code 0326U?

CPT 0326U can be used to describe a specific laboratory test called Guardant360® from Guardant Health Inc. This test utilizes next-generation sequencing (NGS) targeted sequence analysis panel to evaluate cell-free circulating DNA from a blood specimen. It analyzes 83 or more genes associated with solid organ neoplasms, including sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.

2. Official Description

The official description of CPT code 0326U is: ‘Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 83 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.’

3. Procedure

1. The lab analyst processes a blood specimen to preserve cell-free DNA (cfDNA) and isolate circulating-tumor DNA (ct-DNA).
2. The ct-DNA is evaluated using a next-generation sequencing (NGS) targeted gene panel, which determines the order of DNA or RNA nucleotides in many genes.
3. The digital sequence library from the ct-DNA is compared to a comprehensive panel of 83 or more solid organ cancer-related genes.
4. The test detects single nucleotide polymorphisms (SNPs), copy number variations (CNVs), gene rearrangements, microsatellite instability, and tumor mutational burden.
5. The results provide information on actionable genetic mutations that can guide treatment decisions and improve patient outcomes.

4. Qualifying circumstances

CPT 0326U is applicable for patients with a tumor in any organ, such as lung, breast, colorectal, skin (melanoma), and genitourinary tract. It is often ordered as a first-line test or in addition to a tissue biopsy. The test offers advantages over invasive tissue biopsies, including reduced complications, cost, and time to diagnosis, as well as superior detection of actionable genetic mutations.

5. When to use CPT code 0326U

CPT code 0326U should be used specifically for the Guardant360® test from Guardant Health Inc. It should not be reported using any other CPT code. This code is appropriate when evaluating cell-free circulating DNA for 83 or more genes associated with solid organ neoplasms, including sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden.

6. Documentation requirements

To support a claim for CPT 0326U, the following documentation is required:

• Patient’s clinical indication for the test
• Specific details of the Guardant360® test, including the genes analyzed and the type of analysis performed
• Date of service and specimen collection
• Results of the test, including any detected sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden
• Signature of the lab analyst performing the test

7. Billing guidelines

When billing for CPT 0326U, ensure that the test performed is the Guardant360® test from Guardant Health Inc. Report one unit of this code for a single specimen analyzed on a single date of service. Some payers may also provide separate reimbursement for specimen collection. It is important to use this code only for the appropriate proprietary test and not report it using any other CPT code.

8. Historical information

CPT 0326U was added to the Current Procedural Terminology system on July 1, 2022. There have been no updates or changes to the code since its addition.

9. Examples

1. A patient with suspected lung cancer undergoes the Guardant360® test to evaluate the presence of specific genetic mutations that can guide targeted therapy decisions.
2. A patient with breast cancer undergoes the Guardant360® test to assess the tumor mutational burden and identify potential treatment options.
3. A patient with colorectal cancer undergoes the Guardant360® test to detect microsatellite instability and guide treatment decisions.
4. A patient with melanoma undergoes the Guardant360® test to analyze gene rearrangements and identify potential targeted therapies.
5. A patient with genitourinary tract cancer undergoes the Guardant360® test to evaluate gene copy number amplifications and guide treatment choices.
6. A patient with an unknown primary tumor undergoes the Guardant360® test to identify the origin of the tumor based on genetic markers.
7. A patient with suspected solid organ neoplasm undergoes the Guardant360® test as a non-invasive alternative to tissue biopsy.
8. A patient with a history of cancer undergoes the Guardant360® test for surveillance and monitoring of potential recurrence or treatment response.
9. A patient with a family history of cancer undergoes the Guardant360® test to assess their genetic predisposition and guide preventive measures.
10. A patient with a rare solid organ neoplasm undergoes the Guardant360® test to identify potential therapeutic targets not commonly associated with their tumor type.