New LCD Expanding Medicare Coverage for Circulating Tumor Cells Tests Is a Win for Biocept

Biocept announced that it has received expanded Medicare coverage for use of its Target Selector assay to identify HER-2 positive circulating tumor cells under a final CMS local coverage determination (LCD) that took effect on July 4. The New LCD for CTC Tests Although the LCD doesn’t mention any particular test brand or technology by name, it does outline Medicare coverage criteria for circulating tumor cell (CTC) assays. Tests that detect biomarkers from CTC may be covered when used in cancer types with established biomarker testing that meets national guidelines or the recommendations of a recognized professional society. The LCD outlines four basic criteria for coverage: Use Must Be Appropriate Appropriate uses include diagnosis, risk stratification, prediction, or monitoring of therapy response, where these actions have recognized clinical utility. Rationale for Testing Must Be Appropriate The CTC test is covered only if either: The patient is newly diagnosed and not previously tested; or There’s an established rationale for retesting such as demonstrated disease progression or suspicion of treatment resistance. Test Technology Must Be Validated Even if the first two criteria are met, Medicare will cover the assay only if the CTC test technology has successfully completed a comprehensive technical assessment […]