MolDX: Breast Cancer Index (BCI) Gene Expression Test

Summary of Evidence Analysis of Evidence General Information Associated Information Sources of Information Bibliography Revision History Information Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Versions Keywords Local Coverage Determination (LCD) MolDX: Breast Cancer Index® (BCI) Gene Expression Test L37794 Expand All | Collapse All  Email Document  Download  Add to basket Contractor Information Contractor Name Contract Type Contract Number Jurisdiction States LCD Information Document Information LCD ID L37794 LCD Title MolDX: Breast Cancer Index® (BCI) Gene Expression Test Proposed LCD in Comment Period N/A Source Proposed LCD DL37794 Original Effective Date For services performed on or after 03/11/2019 Revision Effective Date For services performed on or after 07/03/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 03/18/2021 Notice Period End Date 05/01/2021 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion

This Medicare contractor will provide limited coverage for the Breast Cancer Index® (BCI) gene expression test (Biotheranostics, Inc., San Diego, CA). The BCI test is used by physicians to provide a genomic-based estimate of distant recurrence risk when considering addition of chemotherapy, and/or late distant recurrence risk and endocrine responsiveness when considering extension of endocrine therapy, depending upon when in the continuum of care testing is requested. The BCI test is covered for postmenopausal women with invasive breast cancer when the following criteria are met: Pathology reveals invasive carcinoma of the breast that is estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) and Human Epidermal Growth Factor Receptor 2 negative (HER2-); and Patient has early-stage disease {Tumor, Node, Metastasis (TNM) stage T1-3, pN0-N1, M0}; and Patient has no evidence of distant breast cancer metastasis (i.e., non-relapsed); and Test results will be used in determining treatment management of the patient for chemotherapy and/or endocrine therapy.