MolDX: Breast Cancer Index (BCI) Gene Expression Test Final LCD - Effective April 16, 2019

The following Local Coverage Determination (LCD) has completed the Open Public and Contractor Advisory Committee (CAC) comment period and is now finalized under contractor numbers 02102 (AK), 02202 (ID), 02302 (OR), 02402 (WA), 03102 (AZ), 03202 (MT), 03302 (ND), 03402 (SD), 03502 (UT) and 03602 (WY). 

Medicare Coverage Database (MCD) Number/Contractor Determination Number: L37824

LCD Title: MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test

Effective Date: April 16, 2019

Summary of LCD: This Medicare contractor will provide limited coverage for the Breast Cancer IndexTM (BCI) gene expression test (Biotheranostics, Inc., San Diego, CA) for the management of postmenopausal women diagnosed with early-stage (TNM stage T1-3, pN0, M0), node-negative, non-relapsed, ER and/or PR-positive, HER2-negative breast cancer, who are being or will be treated with primary adjuvant endocrine therapy. The BCI test is used by physicians to provide a genomic-based estimate of 10y 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.

INDUSTRY NEWS TAGS: Molecular Diagnostics

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