How To Use CPT Code 0023U

CPT 0023U describes a molecular pathology test called LeukoStrat® CDx FLT3 Mutation Assay by Invivoscribe Technologies, Inc. This test is used to identify mutations in the FLT3 gene, specifically internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, in patients with acute myelogenous leukemia (AML). The test helps in treatment planning for AML patients by providing information on the presence or absence of FLT3 mutations and guiding the use of midostaurin. This article will provide an overview of CPT code 0023U, including its official description, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples.

1. What is CPT Code 0023U?

CPT 0023U is a proprietary laboratory analysis (PLA) code that represents the LeukoStrat® CDx FLT3 Mutation Assay by Invivoscribe Technologies, Inc. This molecular pathology test is designed to detect mutations in the FLT3 gene, specifically internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations. It is used to aid in treatment planning for patients with acute myelogenous leukemia (AML).

2. Official Description

The official description of CPT code 0023U is: ‘Oncology (acute myelogenous leukemia), DNA, genotyping of internal tandem duplication, p.D835, p.I836, using mononuclear cells, reported as detection or non-detection of FLT3 mutation and indication for or against the use of midostaurin.’

3. Procedure

1. The procedure begins with the isolation of mononuclear cells from the patient’s specimen, such as blood.
2. The isolated cells are then subjected to DNA isolation and amplification using polymerase chain reaction (PCR) techniques.
3. The amplified DNA is analyzed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations in the FLT3 gene, specifically at positions p.D835 and p.I836.
4. If the mutations are present, the test indicates their detection and provides information on whether midostaurin should be used as part of the treatment plan.
5. If the mutations are not detected, the test provides an indication against the use of midostaurin.

4. Qualifying circumstances

CPT code 0023U is typically ordered for patients with acute myelogenous leukemia (AML) to evaluate prognosis and determine appropriate treatment options, such as the use of midostaurin. The test specifically targets the detection or non-detection of internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations in the FLT3 gene, at positions p.D835 and p.I836. It is important to note that this test is specific to the LeukoStrat® CDx FLT3 Mutation Assay by Invivoscribe Technologies, Inc., and should not be confused with other FLT3 mutation tests.

5. When to use CPT code 0023U

CPT code 0023U should be used when a physician or healthcare provider orders the LeukoStrat® CDx FLT3 Mutation Assay by Invivoscribe Technologies, Inc. for a patient with acute myelogenous leukemia (AML). The test is used to identify the presence or absence of internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations in the FLT3 gene, specifically at positions p.D835 and p.I836. The results of the test provide valuable information for treatment planning, particularly in determining the use of midostaurin.

6. Documentation requirements

When reporting CPT code 0023U, the following documentation should be included:

• Indication for the test (e.g., diagnosis of acute myelogenous leukemia)
• Details of the specimen used for testing (e.g., blood)
• Specific mutations detected or not detected (internal tandem duplication and tyrosine kinase domain mutations at positions p.D835 and p.I836)
• Indication for or against the use of midostaurin based on the test results
• Signature of the ordering physician or healthcare provider

7. Billing guidelines

When billing for CPT code 0023U, it is important to note that this is a proprietary laboratory analysis (PLA) code. It should only be used for the LeukoStrat® CDx FLT3 Mutation Assay by Invivoscribe Technologies, Inc. and should not be reported with any other CPT codes. Some payers may separately reimburse for the collection of the specimen using a code such as 36415. It is recommended to review payer-specific guidelines and policies for accurate billing and reimbursement.

8. Historical information

CPT code 0023U was added to the Current Procedural Terminology (CPT) system on October 1, 2017. There have been no updates or changes to the code since its addition.

9. Examples

1. A physician orders the LeukoStrat® CDx FLT3 Mutation Assay for a patient diagnosed with acute myelogenous leukemia to determine the presence or absence of internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations in the FLT3 gene.
2. An oncologist requests the test for a patient with AML to guide treatment decisions, specifically to determine the indication for or against the use of midostaurin based on the FLT3 mutation status.
3. A hematologist orders the LeukoStrat® CDx FLT3 Mutation Assay for a newly diagnosed AML patient to evaluate prognosis and inform treatment planning.
4. A healthcare provider requests the test for a patient with suspected AML to confirm the presence or absence of FLT3 mutations and guide appropriate treatment options.
5. A medical oncologist orders the LeukoStrat® CDx FLT3 Mutation Assay for a patient with relapsed AML to assess the FLT3 mutation status and consider midostaurin as a potential treatment option.
6. A hematopathologist orders the test for a patient with AML to provide additional molecular information for a comprehensive diagnostic evaluation.
7. An oncology team requests the LeukoStrat® CDx FLT3 Mutation Assay for a pediatric patient with AML to guide treatment decisions and optimize therapeutic strategies.
8. A physician orders the test for a patient enrolled in a clinical trial to assess the FLT3 mutation status and evaluate the potential use of midostaurin as part of the investigational treatment protocol.
9. An oncology specialist requests the LeukoStrat® CDx FLT3 Mutation Assay for a patient with AML to determine the presence or absence of FLT3 mutations and tailor treatment options accordingly.
10. A healthcare provider orders the test for a patient with AML to provide additional molecular information for risk stratification and treatment planning.