How To Use CPT Code 0046U

CPT 0046U describes a proprietary laboratory analysis (PLA) code for the FLT3 ITD MRD by NGS LabPMM LLC, an Invivoscribe Technologies, Inc., Company. This article will cover the description, official details, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples of CPT code 0046U.

1. What is CPT Code 0046U?

CPT 0046U is a proprietary laboratory analysis (PLA) code that specifically applies to the FLT3 ITD MRD test performed by NGS LabPMM LLC, an Invivoscribe Technologies, Inc., Company. This test is used to detect the presence of specific changes in the FMS gene for fms–related tyrosine kinase 3 (FLT3) over the internal tandem duplication (ITD) variants. It is primarily used to determine the presence of minimal residual disease (MRD) in conditions such as acute myeloid leukemia (AML).

2. Official Description

The official description of CPT code 0046U is: ‘FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia) internal tandem duplication (ITD) variants, quantitative.’

3. Procedure

  1. The lab analyst performs all technical steps required for the FLT3 ITD MRD test, starting from extracting nucleic acids from the specimen through methods such as cell lysis and digestion.
  2. The lab analyst then amplifies and stabilizes the quantity of nucleic acid for analysis using techniques such as amplification with primers.
  3. Next, the lab analyst detects and quantifies the target genes, specifically the FLT3 ITD variants, using methods such as nucleic acid probes.
  4. A single unit of CPT code 0046U represents the next generation sequencing (NGS) testing for specific changes in the FLT3 gene known as internal tandem duplication (ITD) variants using primers or amplification starting points.

4. Qualifying circumstances

CPT code 0046U is commonly ordered by providers for patients with acute myeloid leukemia (AML), particularly those who do not show inherited genetic changes related to the condition. This test is often performed on patients with cytogenetically normal AML (CN AML), where the patient may have a genetic abnormality that affects only the cells that become cancerous. The most common mutation found in CN AML is the FLT3 ITD mutation.

5. When to use CPT code 0046U

CPT code 0046U should be used specifically for the FLT3 ITD MRD test performed by NGS LabPMM LLC, an Invivoscribe Technologies, Inc., Company. It should not be reported with any other CPT code. This code is used to detect the presence of FLT3 ITD variants and determine the minimal residual disease (MRD) in conditions such as acute myeloid leukemia (AML).

6. Documentation requirements

To support a claim for CPT code 0046U, the following documentation is required:

  • Indication of the specific test performed, FLT3 ITD MRD
  • Date of service
  • Signature of the lab analyst performing the test

7. Billing guidelines

When billing for CPT code 0046U, ensure that the test is performed by NGS LabPMM LLC, an Invivoscribe Technologies, Inc., Company. Report one unit of this code for a single specimen analyzed on a single date of service. It should not be reported with any other CPT code. Some payers may separately reimburse for specimen collection, so it is recommended to check with the appropriate payer. Additionally, any prep work preceding the test, such as tissue selection or microdissection, may be reported separately using the appropriate CPT codes.

8. Historical information

CPT code 0046U was added to the Current Procedural Terminology system on July 1, 2018. There have been no updates or changes to the code since its addition.

9. Examples

  1. A patient with acute myeloid leukemia (AML) undergoes the FLT3 ITD MRD test to determine the presence of minimal residual disease.
  2. A provider orders the FLT3 ITD MRD test for a patient with cytogenetically normal AML (CN AML) to assess the FLT3 ITD mutation.
  3. A lab performs the FLT3 ITD MRD test on a patient with suspected acute myeloid leukemia to aid in diagnosis and treatment planning.
  4. A patient previously diagnosed with AML undergoes the FLT3 ITD MRD test to monitor the effectiveness of treatment and detect any residual disease.
  5. A provider orders the FLT3 ITD MRD test for a patient with a history of AML to assess the risk of disease recurrence.
  6. A lab performs the FLT3 ITD MRD test on a patient with suspected minimal residual disease after treatment for AML.
  7. A patient with acute myeloid leukemia (AML) undergoes the FLT3 ITD MRD test to determine the response to therapy and guide further treatment decisions.
  8. A provider orders the FLT3 ITD MRD test for a patient with relapsed AML to assess the extent of disease recurrence.
  9. A lab performs the FLT3 ITD MRD test on a patient with suspected minimal residual disease after bone marrow transplantation for AML.
  10. A patient previously treated for AML undergoes the FLT3 ITD MRD test to monitor for disease relapse or progression.

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