How To Use CPT Code 0340U

CPT 0340U describes the analysis of minimal residual disease (MRD) from plasma for oncology patients. This article will cover the description, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples.

1. What is CPT Code 0340U?

CPT 0340U can be used to analyze minimal residual disease (MRD) from plasma for oncology patients. This code is specific to the Signatera™ test offered by Natera Inc. The test utilizes a patient’s plasma specimen to perform a targeted sequence analysis using circulating tumor DNA (ctDNA). By comparing the ctDNA to a customized DNA panel based on prior next-generation sequencing (NGS) analysis of the patient’s tumor and germline DNA, the test can determine the presence or absence of MRD and correlate it with disease burden if necessary.

2. Official Description

The official description of CPT code 0340U is: ‘Oncology (pan-cancer), analysis of minimal residual disease (MRD) from plasma, with assays personalized to each patient based on prior next-generation sequencing of the patient’s tumor and germline DNA, reported as absence or presence of MRD, with disease-burden correlation, if appropriate.’

3. Procedure

1. The lab analyst processes the patient’s plasma specimen to preserve cell-free DNA (cfDNA) and isolates circulating tumor DNA (ctDNA).
2. The ctDNA is then evaluated using a targeted gene panel through next-generation sequencing (NGS).
3. The NGS analysis compares the ctDNA to a customized DNA panel based on prior sequencing of the patient’s tumor and germline DNA.
4. The result of the analysis is reported as the absence or presence of minimal residual disease (MRD).
5. If necessary, the presence of MRD can be correlated with disease burden.

4. Qualifying circumstances

CPT 0340U is applicable to oncology patients who require the analysis of minimal residual disease (MRD) from plasma. The test is specifically designed for the Signatera™ test offered by Natera Inc. It is important to note that this code is proprietary and can only be used for this specific test.

5. When to use CPT code 0340U

CPT code 0340U should be used when analyzing minimal residual disease (MRD) from plasma for oncology patients using the Signatera™ test from Natera Inc. It is important to ensure that the test is performed for the appropriate indications, such as detecting MRD after surgery, monitoring cancer recurrence after adjuvant therapy, or assessing treatment response after relapse.

6. Documentation requirements

To support a claim for CPT code 0340U, the following documentation is required:

• Indication for the test and the need to analyze minimal residual disease (MRD) from plasma
• Details of the prior next-generation sequencing (NGS) analysis of the patient’s tumor and germline DNA
• Date of service and the specific test performed (Signatera™ from Natera Inc.)
• Result of the analysis, reported as the absence or presence of MRD
• If applicable, correlation of MRD with disease burden
• Signature of the lab analyst performing the test

7. Billing guidelines

When billing for CPT code 0340U, it is important to ensure that the test is performed using the Signatera™ test from Natera Inc. This code is specific to this proprietary test and should not be reported using any other CPT code. It is also important to follow any specific billing guidelines provided by the payer or insurance company. Additionally, consider reporting any separate codes for specimen collection if applicable.

8. Historical information

CPT code 0340U was added to the Current Procedural Terminology system on October 1, 2022. As a relatively new code, there have been no historical changes or updates since its addition.

9. Examples

1. A patient with breast cancer undergoes the Signatera™ test to analyze minimal residual disease (MRD) from plasma after completing adjuvant therapy.
2. A patient with lung cancer undergoes the Signatera™ test to monitor for cancer recurrence after surgical resection.
3. A patient with colorectal cancer undergoes the Signatera™ test to assess treatment response after relapse.
4. A patient with melanoma undergoes the Signatera™ test to detect minimal residual disease (MRD) after completing adjuvant therapy.
5. A patient with pancreatic cancer undergoes the Signatera™ test to monitor for cancer recurrence after neoadjuvant therapy.
6. A patient with prostate cancer undergoes the Signatera™ test to assess treatment response after relapse.
7. A patient with ovarian cancer undergoes the Signatera™ test to detect minimal residual disease (MRD) after completing adjuvant therapy.
8. A patient with lymphoma undergoes the Signatera™ test to monitor for cancer recurrence after chemotherapy.
9. A patient with bladder cancer undergoes the Signatera™ test to assess treatment response after relapse.
10. A patient with leukemia undergoes the Signatera™ test to detect minimal residual disease (MRD) after completing adjuvant therapy.