bioTheranostics has announced that its Breast Cancer Index test has been awarded Medicare coverage. The Centers for Medicare and Medicaid Services (CMS) posted a positive coverage and reimbursement policy after evaluation by the MolDx molecular diagnostic technology assessment program.
The Breast Cancer Index is a molecular genomic test that quantifies risk of breast cancer recurrence and predicts which patients have a high likelihood of benefitting from extended endocrine therapy. The Medicare policy covers use of the test to predict risk of late (five to 10 years) distant recurrence in women with early stage, estrogen receptor-positive breast cancer who are considering extended therapy but are concerned about continuing anti-hormonal therapy because of documented toxicity or possible significant patient-specific side effects. In addition to new claims, Medicare coverage and payment for the Breast Cancer Index will be made retrospectively for previously submitted claims.
Nicolas Barthelemy, President and CEO of bioTheranostics, says that securing Medicare coverage is a significant achievement that will help ensure broader patient access to an important breakthrough in breast cancer management. “This critical information will allow many women to avoid unnecessary treatment and potential side effects that can adversely affect their health and quality of life,” he says.
The Medicare coverage decision was based on a review of the scientific evidence supporting the analytical validity, clinical validity, and clinical utility of the Breast Cancer Index. It is one of the first coverage determinations for a molecular cancer diagnostic technology handed down by the rigorous evaluative process since the inception of MolDx in 2011. Learn more about the Breast Cancer Index test.
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