Biocept HER2 Assay Gains Coverage Under Medicare Local Coverage Determination for CTC Tests

Biocept said Wednesday that it has received expanded Medicare coverage for the use of its Target Selector assay to identify HER2-positive circulating tumor cells under a final local coverage determination by the Centers for Medicare and Medicaid Services’ Molecular Diagnostics Program providing limited coverage for the use of circulating tumor cell assays.

Effective July 4, 2021, the LCD is not specific to any test technology or brand. It outlines a limited coverage policy for assays that detect biomarkers from circulating tumor cells in instances that meet certain criteria, including use in cancer types with established biomarker testing, as recommended by professional society or national guidelines.

Appropriate uses include diagnosis, risk stratification, prediction, or monitoring of therapy response, where these actions have recognized clinical utility. For coverage, a patient must be either newly diagnosed and not previously tested, or there must be an established rationale for retesting such as demonstrated disease progression or suspicion of treatment resistance.

Source: https://www.genomeweb.com/molecular-diagnostics/biocept-her2-assay-gains-coverage-under-medicare-local-coverage-determination#.YQGVv45KiUk