How To Use CPT Code 0314U

CPT 0314U describes a proprietary laboratory analysis (PLA) code for DecisionDx® DiffDx™ Melanoma from Castle Biosciences Inc. This article will cover the official description, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples of CPT code 0314U.

1. What is CPT Code 0314U?

CPT 0314U is a unique PLA code that represents the DecisionDx® DiffDx™ Melanoma test offered by Castle Biosciences Inc. This test utilizes formalin-fixed paraffin-embedded (FFPE) tissue from a skin lesion suspected to be cutaneous melanoma. It employs reverse-transcription polymerase chain reaction (RT-PCR) gene expression profiling to analyze the activity of 35 genes (32 content and 3 housekeeping). The test results are reported as a categorical result, categorizing the lesion as benign, intermediate, or malignant.

2. Official Description

The official description of CPT code 0314U is: ‘Oncology (cutaneous melanoma), mRNA gene expression profiling by RT-PCR of 35 genes (32 content and 3 housekeeping), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a categorical result (i.e., benign, intermediate, malignant).’

3. Procedure

1. The laboratory analyst performs the DecisionDx® DiffDx™ Melanoma test using formalin-fixed paraffin-embedded (FFPE) tissue from a skin lesion.
2. The test utilizes reverse transcription-polymerase chain reaction (RT-PCR) to measure the activity of 35 genes (32 content and 3 housekeeping) in the specimen.
3. An algorithmic analysis is performed on the gene expression profile to categorize the lesion as benign, intermediate, or malignant.

4. Qualifying circumstances

CPT code 0314U is applicable to patients suspected to have cutaneous melanoma. The test is performed on formalin-fixed paraffin-embedded (FFPE) tissue obtained from a skin lesion. It is important to note that this code specifically applies to the DecisionDx® DiffDx™ Melanoma test from Castle Biosciences Inc.

5. When to use CPT code 0314U

CPT code 0314U should be used when a skin lesion is suspected to be cutaneous melanoma and the DecisionDx® DiffDx™ Melanoma test is performed using FFPE tissue. This code is specific to the Castle Biosciences Inc. test and should not be used for other similar tests or for melanoma recurrence testing.

6. Documentation requirements

To support a claim for CPT code 0314U, the following documentation is required:

• Indication of the skin lesion suspected to be cutaneous melanoma
• Use of formalin-fixed paraffin-embedded (FFPE) tissue for the test
• Date of the test
• Results of the algorithmic analysis categorizing the lesion as benign, intermediate, or malignant

7. Billing guidelines

When billing for CPT code 0314U, ensure that the test is performed by Castle Biosciences Inc. and that the DecisionDx® DiffDx™ Melanoma test is specifically used. This code should not be reported with any other CPT codes. It is important to distinguish this test from other similar tests offered by Castle Biosciences Inc., such as myPath® Melanoma and DecisionDx-Melanoma.

8. Historical information

CPT code 0314U was added to the Current Procedural Terminology system on April 1, 2022. There have been no updates or changes to the code since its addition.

9. Examples

1. A patient presents with a suspicious skin lesion, and the DecisionDx® DiffDx™ Melanoma test is performed using FFPE tissue. The algorithmic analysis categorizes the lesion as malignant.
2. Following an inconclusive result from a previous test, a skin lesion suspected to be cutaneous melanoma undergoes the DecisionDx® DiffDx™ Melanoma test. The test results categorize the lesion as intermediate.
3. A patient with a skin lesion undergoes the DecisionDx® DiffDx™ Melanoma test, and the algorithmic analysis determines the lesion to be benign.
4. After a biopsy of a suspicious skin lesion, the DecisionDx® DiffDx™ Melanoma test is performed using FFPE tissue. The test results indicate the lesion to be malignant.
5. A skin lesion suspected to be cutaneous melanoma is analyzed using the DecisionDx® DiffDx™ Melanoma test. The algorithmic analysis categorizes the lesion as intermediate.
6. Following a previous inconclusive test, the DecisionDx® DiffDx™ Melanoma test is performed on a skin lesion. The test results classify the lesion as benign.
7. A patient presents with a suspicious skin lesion, and the DecisionDx® DiffDx™ Melanoma test is performed using FFPE tissue. The algorithmic analysis determines the lesion to be malignant.
8. After an inconclusive result from a previous test, a skin lesion suspected to be cutaneous melanoma undergoes the DecisionDx® DiffDx™ Melanoma test. The test results categorize the lesion as intermediate.
9. A patient with a skin lesion undergoes the DecisionDx® DiffDx™ Melanoma test, and the algorithmic analysis determines the lesion to be benign.
10. Following a biopsy of a suspicious skin lesion, the DecisionDx® DiffDx™ Melanoma test is performed using FFPE tissue. The test results indicate the lesion to be malignant.