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Biotheranostics Breast Cancer Test Receives Expanded Medicare Coverage Determination

NEW YORK (GenomeWeb) — Biotheranostics announced today that its Breast Cancer Index (BCI) genomic test has has been issued an expanded local coverage determination (LCD) by Medicare contractor Noridian.

The PCR-based test evaluates the expression of 11 genes to help physicians predict the risk of late disease recurrence and identify which early-stage breast cancer patients are likely to benefit from continuing adjuvant endocrine therapy beyond five years.

In 2014, the BCI received a positive coverage determination from Medicare administrator Palmetto GBA — which runs the Molecular Diagnostic Services Program that establishes Medicare coverage and reimbursement for molecular diagnostics — for its use in early-stage, estrogen receptor (ER)-positive breast cancer patients.

Under the expanded LCD — which will go into effect on April 16 — coverage will include the management of postmenopausal women diagnosed with early-stage, node-negative, non-relapsed, ER and/or progesterone receptor-positive, HER2-negative breast cancer, who are being or will be treated with primary adjuvant endocrine therapy.

"We are pleased that Medicare and Palmetto MolDx have continued to recognize the clinical utility of BCI and the strength of its clinical validation, thus increasing patient and physician access to this important technology," Biotheranostics CSO Catherine Schnabel said in a statement.

About a year ago, San Diego-based Biotheranostics agreed to pay $2 million to settle US Department of Justice allegations that the company improperly billed Medicare for the BCI.