How To Use CPT Code 0316U

CPT 0316U describes a proprietary laboratory analysis (PLA) code for the evaluation of Borrelia burgdorferi (Lyme disease) using the OspA protein in urine. This article will cover the official description, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples of CPT code 0316U.

1. What is CPT Code 0316U?

CPT 0316U is a unique PLA code that specifically applies to the Lyme Borrelia Nanotrap® Urine Antigen Test from Galaxy Diagnostics Inc. This test utilizes specialized nanoparticles (Nanotrap®) to capture the outer surface protein A (OspA) present in the urine of patients infected with Borrelia species, the organisms that cause Lyme disease. By enriching the sample and using Western blot lab procedures, the test quantifies the OspA protein as an indicator of active infection.

2. Official Description

The official description of CPT code 0316U is: ‘Borrelia burgdorferi (Lyme disease), OspA protein evaluation, urine.’

3. Procedure

1. The lab analyst processes a urine specimen from a patient suspected of having Lyme disease.
2. Specialized nanoparticles (Nanotrap®) are used to capture any outer surface protein A (OspA) present in the urine.
3. A sample enrichment step is performed to concentrate the OspA protein up to 10,000-fold, ensuring detection even in small quantities.
4. The lab analyst applies an electrical field across a gel containing the specimen, causing the protein fractions to migrate apart.
5. The proteins are then transferred to a membrane through blotting, allowing for the quantification of the OspA level in the specimen.
6. The presence of OspA confirms active infection with Borrelia species, the organisms responsible for Lyme disease.

4. Qualifying circumstances

CPT code 0316U is applicable for patients suspected of having Lyme disease. The test is used as a direct detection method for Borrelia infection, either alone or in addition to antibody testing. Direct detection may be more accurate than the standard two-tiered antibody testing, which can result in false positives or negatives due to delayed antibody response or limited test sensitivity.

5. When to use CPT code 0316U

CPT code 0316U should be used when the Galaxy Diagnostics Inc. Lyme Borrelia Nanotrap® Urine Antigen Test is performed to evaluate the presence of the OspA protein in urine. It is important to note that this code should only be reported for the specific proprietary test described and should not be reported using any other CPT code.

6. Documentation requirements

To support a claim for CPT code 0316U, the following documentation is required:

• Patient’s suspected diagnosis of Lyme disease
• Specific information about the proprietary test performed, including the use of specialized nanoparticles (Nanotrap®) and the enrichment process
• Date of service and the specimen analyzed
• Results of the Western blot lab procedure, indicating the level of OspA protein in the specimen
• Confirmation of active infection with Borrelia species
• Signature of the lab analyst performing the test

7. Billing guidelines

When billing for CPT code 0316U, ensure that the test is performed using the Galaxy Diagnostics Inc. Lyme Borrelia Nanotrap® Urine Antigen Test. This code should not be reported using any other CPT code. It is important to report one unit of this code for a single specimen analyzed on a single date of service.

8. Historical information

CPT code 0316U was added to the Current Procedural Terminology system on April 1, 2022. As a relatively new code, there have been no updates or changes since its addition.

9. Examples

1. A lab analyst processes a urine specimen from a patient suspected of having Lyme disease and performs the Galaxy Diagnostics Inc. Lyme Borrelia Nanotrap® Urine Antigen Test to evaluate the OspA protein level.
2. A clinician orders the proprietary test for direct detection of Borrelia infection in a patient with suspected Lyme disease, in addition to antibody testing.
3. The lab analyst captures the OspA protein using specialized nanoparticles (Nanotrap®) and performs the Western blot lab procedure to quantify the protein level, confirming active infection with Borrelia species.
4. A patient presents with symptoms consistent with Lyme disease, and the Galaxy Diagnostics Inc. Lyme Borrelia Nanotrap® Urine Antigen Test is performed to detect the OspA protein in their urine.
5. A lab technician analyzes a urine specimen using the proprietary test to evaluate the presence of the OspA protein, aiding in the diagnosis of Lyme disease.
6. A physician orders the specific test to directly detect Borrelia infection in a patient with suspected Lyme disease, providing more accurate results than traditional antibody testing.
7. A lab analyst performs the Galaxy Diagnostics Inc. Lyme Borrelia Nanotrap® Urine Antigen Test on a urine sample, confirming the presence of the OspA protein and indicating active infection with Borrelia species.
8. A patient with symptoms suggestive of Lyme disease undergoes the proprietary test, which captures and quantifies the OspA protein in their urine, aiding in the diagnosis and confirmation of active infection.
9. A clinician orders the specialized test to directly detect the presence of Borrelia species in a patient suspected of having Lyme disease, providing valuable information for accurate diagnosis and treatment.
10. A lab technician analyzes a urine specimen using the Galaxy Diagnostics Inc. Lyme Borrelia Nanotrap® Urine Antigen Test, confirming the presence of the OspA protein and supporting the diagnosis of Lyme disease.