How To Use CPT Code 0108U

CPT 0108U describes the use of whole slide-digital imaging and computer-assisted quantitative immunolabeling of 9 protein biomarkers to assess the risk of progression to high-grade dysplasia or cancer in patients with Barrett’s esophagus. This article will cover the description, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples.

1. What is CPT Code 0108U?

CPT 0108U is a proprietary laboratory analysis (PLA) code that applies to the TissueCypher® Barrett’s Esophagus Assay from Cernostics Lab. This test helps pathologists interpret esophageal biopsies and predicts the risk for high-grade dysplasia or esophageal cancer in patients with Barrett’s esophagus. It involves the use of whole slide-digital imaging and computer-assisted quantitative immunolabeling of 9 protein biomarkers.

2. Official Description

The official description of CPT code 0108U is: ‘Gastroenterology (Barrett’s esophagus), whole slide-digital imaging, including morphometric analysis, computer-assisted quantitative immunolabeling of 9 protein biomarkers (p16, AMACR, p53, CD68, COX-2, CD45RO, HIF1a, HER-2, K20) and morphology, formalin-fixed paraffin-embedded tissue, algorithm reported as risk of progression to high-grade dysplasia or cancer.’

3. Procedure

1. The lab analyst applies an immunofluorescent stain to formalin-fixed paraffin-embedded tissue taken from a biopsy during upper gastrointestinal endoscopy.
2. The fluorescence-labeled slides are scanned for 9 protein biomarkers to assess molecular, cellular, and morphologic changes.
3. An algorithm is used to analyze the results and report the risk of progression to high-grade dysplasia or cancer.

4. Qualifying circumstances

CPT 0108U is ordered for patients with early signs of Barrett’s esophagus with nondysplastic or indeterminate or low-grade dysplasia. Barrett’s esophagus refers to precancerous changes in the esophageal tissues caused by chronic gastroesophageal reflux disease (GERD). The test is performed on formalin-fixed paraffin-embedded tissue samples.

5. When to use CPT code 0108U

CPT code 0108U should be used when the TissueCypher® Barrett’s Esophagus Assay from Cernostics Lab is performed to assess the risk of progression to high-grade dysplasia or cancer in patients with Barrett’s esophagus. It should not be reported with any other CPT code.

6. Documentation requirements

To support a claim for CPT code 0108U, the following documentation is required:

• Indication for the test: Early signs of Barrett’s esophagus with nondysplastic or indeterminate or low-grade dysplasia
• Details of the tissue sample: Formalin-fixed paraffin-embedded tissue
• Immunolabeling results for the 9 protein biomarkers
• Algorithmic analysis and the reported risk of progression to high-grade dysplasia or cancer

7. Billing guidelines

When billing for CPT code 0108U, report one unit of this code for a single specimen analyzed on a single date of service. Do not report this test with any other CPT code. Some payers may pay separately for the collection of the specimen, so it is important to check with the appropriate payer.

8. Historical information

CPT code 0108U was added to the Current Procedural Terminology system on October 1, 2019. There have been no updates to the code since its addition.

9. Examples

1. A patient with Barrett’s esophagus undergoes the TissueCypher® Barrett’s Esophagus Assay to assess their risk of progression to high-grade dysplasia or cancer.
2. A pathologist analyzes the formalin-fixed paraffin-embedded tissue sample using whole slide-digital imaging and computer-assisted quantitative immunolabeling of the 9 protein biomarkers.
3. The algorithmic analysis of the test results indicates a low risk of progression to high-grade dysplasia or cancer for the patient.
4. Based on the test results, the patient’s healthcare provider develops a surveillance plan to closely monitor their condition and detect any potential progression.
5. A biopsy from a patient with Barrett’s esophagus is sent to the lab for the TissueCypher® Barrett’s Esophagus Assay, which provides valuable information for risk assessment and management decisions.
6. The immunolabeling of the tissue sample reveals specific protein biomarkers that help predict the patient’s risk of developing high-grade dysplasia or cancer.
7. The algorithmic analysis of the test results shows a moderate risk of progression to high-grade dysplasia or cancer, prompting the healthcare provider to consider more aggressive treatment options.
8. A patient with Barrett’s esophagus undergoes the TissueCypher® Barrett’s Esophagus Assay to assess their risk of progression to high-grade dysplasia or cancer.
9. The test results indicate a high risk of progression to high-grade dysplasia or cancer, leading to the decision for immediate intervention to prevent further complications.
10. Based on the TissueCypher® Barrett’s Esophagus Assay results, the patient’s healthcare provider recommends lifestyle modifications and regular monitoring to minimize the risk of disease progression.