CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
September 2021—Biocept received a positive final local coverage determination that expands Medicare coverage for use of its Target Selector assay to identify the HER2 biomarker from circulating tumor cells. The coverage determination from the Centers for Medicare and Medicaid Services molecular diagnostics program was effective July 4.
The MolDx program was developed by the CMS to identify and establish coverage and reimbursement for molecular diagnostic tests. To receive a favorable MolDx coverage determination, assays must demonstrate clinical utility, fulfill the CMS reasonable and necessary criteria, and meet analytical and clinical validity standards.
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