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The BRCA gene test for breast cancer

Updated: Jul 21, 2023

Is Preauth Required? Preauthorization may be required for the use of HCPCS S3854, a gene expression profiling panel for use in the management of breast cancer treatment (other than Oncotype DX, Prosigna, EndoPredict, MammaPrint, or the Breast Cancer Index). It is used to help clinicians determine which populations of intermediate-risk individuals would benefit from chemotherapy.

Will the claim be denied? Gene expression profiling with the Oncotype DX Breast Recurrence Score, EndoPredict, Prosigna Breast Cancer Prognostic Gene Signature Assay, the Breast Cancer Index or MammaPrint as a technique of managing the treatment of breast cancer is considered medically necessary in certain situations as outlined in the Clinical Indications section of the Clinical UM Guideline for Gene Expression Profiling for Managing Breast Cancer Treatment. The criteria must be met for it to be considered medically necessary. If the criteria are not met, the claim would be denied as the treatment is considered not medically necessary.

When is the following treatment medically necessary for the condition specified? Gene expression profiling for breast cancer is considered medically necessary in certain scenarios, such as when the individual has undergone surgery and full pathological evaluation of the specimen, and the histology is ductal, lobular, mixed, or metaplastic; the tumor is estrogen receptor positive (ER+), or progesterone receptor positive (PR+), or both; the tumor is HER2 (human epidermal growth factor receptor-2) receptor negative; the tumor is pN0 (node negative) or pN1mi with axillary lymph node micrometastasis less than or equal to 2 mm; the tumor is 0.6-1.0 cm moderate/poorly differentiated; the tumor is 0.6-1.0 cm and well-differentiated with any of the following unfavorable features: angiolymphatic invasion, or high nuclear grade, or high histologic grade; the tumor is greater than 1.0 cm and less than or equal to 5.0 cm; chemotherapy is a therapeutic option being considered by the individual and their provider; and no other breast cancer gene expression profiling assay has been conducted for the same tumor (for example a metastatic focus) or from more than one site when the primary tumor is multifocal.

What are the clinical indications that would make this necessary? Gene expression profiling for breast cancer is considered medically necessary in the following situations: I. Gene expression profiling with the Oncotype DX® Breast Recurrence Score, EndoPredict®, Prosigna® Breast Cancer Prognostic Gene Signature Assay, the Breast Cancer IndexSM or MammaPrint® as a technique for managing the treatment of breast cancer when all of the following criteria are met: A. Individual has had surgery and full pathological evaluation of the specimen has been completed; and B. Histology is ductal, lobular, mixed, or metaplastic; and C. Estrogen receptor positive (ER+), or progesterone receptor positive (PR+), or both; and D. HER2 (human epidermal growth factor receptor-2) receptor negative; and E. pN0 (node negative) or pN1mi with axillary lymph node micrometastasis less than or equal to 2 mm; and F. Any of the following: 1. Tumor size 0.6-1.0 cm moderate/poorly differentiated; or 2. Tumor size 0.6-1.0 cm and well-differentiated with any of the following unfavorable features: angiolymphatic invasion

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