How To Use CPT Code 0045U

CPT 0045U describes a proprietary laboratory analysis (PLA) test for breast ductal carcinoma in situ (DCIS). This article will cover the description, official details, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples.

1. What is CPT Code 0045U?

CPT 0045U is a unique code that represents the Oncotype DX® Breast DCIS Score™ test from Genomic Health, Inc. This test is a proprietary laboratory analysis (PLA) that measures the gene expression profiling of 12 specific genes (7 content and 5 housekeeping) in formalin-fixed paraffin-embedded tissue samples from patients with breast ductal carcinoma in situ (DCIS). The test utilizes real-time reverse transcription polymerase chain reaction (RT-PCR) to analyze the gene expression and provides an algorithmic analysis that reports a recurrence score for the patient.

2. Official Description

The official description of CPT code 0045U is: ‘Oncology (breast ductal carcinoma in situ), mRNA, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence score.’

3. Procedure

1. The lab analyst performs gene expression profiling using real-time RT-PCR on formalin-fixed paraffin-embedded tissue samples from patients with breast ductal carcinoma in situ (DCIS).
2. The test measures the activity of 12 specific genes (7 content and 5 housekeeping) to determine the recurrence score for the patient.
3. The lab analyst inputs the test results and patient data into a computer program that utilizes a specific algorithm to analyze the data and generate a recurrence score.
4. The recurrence score is reported to the clinician, providing information about the patient’s risk of recurrence of malignancy after surgery.

4. Qualifying circumstances

CPT code 0045U is used for patients with breast ductal carcinoma in situ (DCIS) who require the Oncotype DX® Breast DCIS Score™ test. This test is ordered by clinicians to determine the patient’s risk of recurrence of malignancy after surgery. The test analyzes the gene expression profiling of 12 specific genes in formalin-fixed paraffin-embedded tissue samples. It is important to note that this code is specific to the Oncotype DX® Breast DCIS Score™ test and should not be used for other similar procedures.

5. When to use CPT code 0045U

CPT code 0045U should be used when the Oncotype DX® Breast DCIS Score™ test is performed on formalin-fixed paraffin-embedded tissue samples from patients with breast ductal carcinoma in situ (DCIS). This test is used to determine the patient’s risk of recurrence of malignancy after surgery. It is important to use this code only for the specific proprietary test and not for any other similar procedures.

6. Documentation requirements

To support a claim for CPT code 0045U, the following documentation is required:

• Order for the Oncotype DX® Breast DCIS Score™ test
• Documentation of the patient’s diagnosis of breast ductal carcinoma in situ (DCIS)
• Formalin-fixed paraffin-embedded tissue samples
• Test results for gene expression profiling of 12 specific genes
• Algorithmic analysis report providing the recurrence score

7. Billing guidelines

When billing for CPT code 0045U, ensure that the test is performed by the specific laboratory or manufacturer associated with the Oncotype DX® Breast DCIS Score™ test. This code should not be reported with any other CPT codes for laboratory/pathology tests. It is important to follow the guidelines of the payer regarding separate payment for specimen collection. Additionally, any prep work preceding the test, such as tissue selection or microdissection, may be separately reported using the appropriate CPT codes.

8. Historical information

CPT code 0045U 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 breast ductal carcinoma in situ (DCIS) undergoes the Oncotype DX® Breast DCIS Score™ test to determine their risk of recurrence after surgery.
2. A clinician orders the Oncotype DX® Breast DCIS Score™ test for a patient with a recent diagnosis of breast ductal carcinoma in situ (DCIS) to guide treatment decisions.
3. A formalin-fixed paraffin-embedded tissue sample from a patient with breast ductal carcinoma in situ (DCIS) is analyzed using the Oncotype DX® Breast DCIS Score™ test to provide a recurrence score.
4. The recurrence score generated by the Oncotype DX® Breast DCIS Score™ test helps the clinician assess the patient’s risk of recurrence and plan appropriate treatment.
5. The Oncotype DX® Breast DCIS Score™ test is performed on a patient with breast ductal carcinoma in situ (DCIS) to provide personalized information about their risk of recurrence after surgery.
6. A patient with breast ductal carcinoma in situ (DCIS) undergoes the Oncotype DX® Breast DCIS Score™ test to determine the need for additional treatment beyond surgery.
7. The recurrence score obtained from the Oncotype DX® Breast DCIS Score™ test assists the clinician in making informed decisions about adjuvant therapy for a patient with breast ductal carcinoma in situ (DCIS).
8. A clinician orders the Oncotype DX® Breast DCIS Score™ test for a patient with a recent diagnosis of breast ductal carcinoma in situ (DCIS) to provide prognostic information.
9. The Oncotype DX® Breast DCIS Score™ test is performed on a formalin-fixed paraffin-embedded tissue sample from a patient with breast ductal carcinoma in situ (DCIS) to assess the likelihood of recurrence after surgery.
10. A patient with breast ductal carcinoma in situ (DCIS) undergoes the Oncotype DX® Breast DCIS Score™ test to determine the optimal treatment approach based on their individual risk of recurrence.