How To Use CPT Code 0016M

CPT 0016M describes a specific oncology test that utilizes mRNA gene expression profiling to determine the molecular subtype of bladder cancer. This article will cover the description, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples.

1. What is CPT Code 0016M?

CPT 0016M is a code used to describe a specialized oncology test that analyzes mRNA gene expression profiling of 219 genes in formalin-fixed paraffin-embedded tissue from a bladder tumor. The test utilizes a specific algorithm to determine the molecular subtype of bladder cancer, which can provide valuable information for assessing the patient’s condition and making treatment decisions.

2. Official Description

The official description of CPT code 0016M is: ‘Oncology (bladder), mRNA, microarray gene expression profiling of 219 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as molecular subtype (luminal, luminal infiltrated, basal, basal claudin-low, neuroendocrine-like)’

3. Procedure

1. The lab analyst collects a formalin-fixed paraffin-embedded tissue sample from a bladder tumor.
2. The mRNA gene expression profiling test is performed on the tissue sample, analyzing the activity of 219 specific genes.
3. The lab analyst inputs the test results and patient information into a computer program.
4. A specific algorithm is applied to the data to determine the molecular subtype of the bladder cancer.
5. The lab analyst reports the molecular subtype, which can help clinicians assess the patient’s condition and make treatment decisions.

4. Qualifying circumstances

CPT code 0016M is used for patients with bladder cancer who require molecular subtype analysis. The test is performed on formalin-fixed paraffin-embedded tissue samples from bladder tumors. The results of the test can provide valuable information for assessing the patient’s condition, classifying the subtype of bladder cancer, and guiding treatment decisions.

5. When to use CPT code 0016M

CPT code 0016M should be used when a clinician orders the mRNA gene expression profiling test for a patient with bladder cancer. The test is particularly useful in cases of high-grade disease, as it can inform decisions about performing chemotherapy before bladder removal surgery. It is important to ensure that the test is performed on formalin-fixed paraffin-embedded tissue samples and that the algorithmic analysis is reported as the molecular subtype of bladder cancer.

6. Documentation requirements

To support a claim for CPT code 0016M, the following documentation is required:

• Documentation of the patient’s diagnosis of bladder cancer
• Documentation of the need for molecular subtype analysis
• Documentation of the use of formalin-fixed paraffin-embedded tissue samples
• Documentation of the specific algorithm used for analysis
• Documentation of the test results and reported molecular subtype
• Signature of the lab analyst performing the test

7. Billing guidelines

When billing for CPT code 0016M, ensure that the test is performed on formalin-fixed paraffin-embedded tissue samples from bladder tumors. Report one unit of this code for a single specimen analyzed on a single date of service. It is important to follow the specific guidelines and requirements of the payer when submitting the claim. CPT code 0016M should not be reported with other codes unless specified by the payer.

8. Historical information

CPT code 0016M was added to the Current Procedural Terminology system on October 1, 2020. There was a code change on July 1, 2022, which updated the number of genes analyzed from 209 to 219. This test has been valuable in providing molecular subtype information for bladder cancer patients since its addition to the CPT system.

9. Examples

1. A clinician orders CPT code 0016M for a patient with bladder cancer to determine the molecular subtype and guide treatment decisions.
2. A lab analyst performs the mRNA gene expression profiling test on a formalin-fixed paraffin-embedded tissue sample from a bladder tumor, reporting the molecular subtype as luminal infiltrated.
3. CPT code 0016M is used to analyze the mRNA gene expression of 219 genes in a bladder tumor specimen, providing valuable information about the molecular subtype of the cancer.
4. A patient with high-grade bladder cancer undergoes the mRNA gene expression profiling test using CPT code 0016M to assess the molecular subtype and inform decisions about chemotherapy before bladder removal surgery.
5. A clinician orders CPT code 0016M for a patient with bladder cancer to classify the molecular subtype as basal claudin-low, which helps determine the appropriate treatment approach.
6. A lab analyst inputs the test results and patient information into a computer program, applying a specific algorithm to determine the molecular subtype of bladder cancer using CPT code 0016M.
7. CPT code 0016M is used to perform mRNA gene expression profiling on formalin-fixed paraffin-embedded tissue samples from bladder tumors, providing valuable information for personalized treatment strategies.
8. A clinician utilizes CPT code 0016M to analyze the mRNA gene expression of 219 genes in a bladder tumor specimen, obtaining crucial insights into the molecular subtype of the cancer.
9. A lab analyst reports the molecular subtype of bladder cancer as luminal based on the results of the mRNA gene expression profiling test performed using CPT code 0016M.
10. CPT code 0016M is used to determine the molecular subtype of bladder cancer, assisting clinicians in making informed decisions about the patient’s treatment plan.