How To Use CPT Code 0153U

CPT 0153U describes the use of gene expression profiling by next-generation sequencing to analyze 101 genes in formalin-fixed paraffin-embedded tissue from breast tumors. 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 0153U?

CPT 0153U can be used to identify the Insight TNBCtype™ test from Insight Molecular Labs. This test utilizes gene expression profiling by next-generation sequencing to analyze 101 genes in formalin-fixed paraffin-embedded tissue from breast tumors. The results of this test provide information on the clinical subtype(s) of triple negative breast cancer (TNBC) and immune cell involvement.

2. Official Description

The official description of CPT code 0153U is: ‘Oncology (breast), mRNA, gene expression profiling by next-generation sequencing of 101 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a triple negative breast cancer clinical subtype(s) with information on immune cell involvement.’

3. Procedure

  1. The lab analyst collects formalin-fixed paraffin-embedded tissue from a breast tumor.
  2. The lab analyst performs gene expression profiling using next-generation sequencing to analyze 101 genes in the tissue sample.
  3. A computer program with a specific algorithm analyzes the data and generates a report on the clinical subtype(s) of triple negative breast cancer and immune cell involvement.

4. Qualifying circumstances

CPT 0153U is used for patients with breast tumors who require gene expression profiling to determine the clinical subtype(s) of triple negative breast cancer and immune cell involvement. The test is performed using formalin-fixed paraffin-embedded tissue samples. This code is specific to the Insight TNBCtype™ test from Insight Molecular Labs.

5. When to use CPT code 0153U

CPT code 0153U should be used when the Insight TNBCtype™ test is performed to analyze 101 genes in formalin-fixed paraffin-embedded tissue from breast tumors. This code should not be used for any other tests or procedures.

6. Documentation requirements

To support a claim for CPT code 0153U, the following documentation is required:

  • Documentation of the patient’s breast tumor diagnosis
  • Confirmation that formalin-fixed paraffin-embedded tissue was used for the test
  • Results of the gene expression profiling analysis and the specific clinical subtype(s) of triple negative breast cancer identified
  • Information on immune cell involvement
  • Date of service
  • Signature of the lab analyst performing the test

7. Billing guidelines

When billing for CPT code 0153U, ensure that the test is performed using formalin-fixed paraffin-embedded tissue from breast tumors and that the Insight TNBCtype™ test from Insight Molecular Labs is used. This code should not be reported with any other CPT codes. It is important to check with the appropriate payer regarding payment for specimen collection.

8. Historical information

CPT code 0153U was added to the Current Procedural Terminology system on January 1, 2020. There have been no updates or changes to the code since its addition.

9. Examples

  1. A patient with a breast tumor undergoes the Insight TNBCtype™ test to determine the clinical subtype(s) of triple negative breast cancer and immune cell involvement.
  2. A physician orders the Insight TNBCtype™ test for a patient with a suspected triple negative breast cancer diagnosis to guide treatment decisions.
  3. A researcher uses the Insight TNBCtype™ test to analyze formalin-fixed paraffin-embedded tissue samples from breast tumors in a clinical trial.
  4. A drug manufacturer utilizes the Insight TNBCtype™ test results to develop targeted chemotherapies for triple negative breast cancer.
  5. A patient with a breast tumor undergoes the Insight TNBCtype™ test to participate in a research study on triple negative breast cancer subtypes.
  6. A clinician orders the Insight TNBCtype™ test to confirm the clinical subtype(s) of triple negative breast cancer in a patient before initiating chemotherapy.
  7. A patient with a breast tumor undergoes the Insight TNBCtype™ test to assess the potential response to hormone therapies.
  8. A physician orders the Insight TNBCtype™ test to determine the clinical subtype(s) of triple negative breast cancer and immune cell involvement in a patient with a recurrent tumor.
  9. A patient with a breast tumor undergoes the Insight TNBCtype™ test to evaluate the prognosis and potential treatment options for triple negative breast cancer.
  10. A clinician uses the Insight TNBCtype™ test results to guide the selection of chemotherapy drugs for a patient with triple negative breast cancer.

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