Reimbursement

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:

  1. Use Must Be Appropriate

Appropriate uses include diagnosis, risk stratification, prediction, or monitoring of therapy response, where these actions have recognized clinical utility.

  1. 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.
  1. 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 ensuring analytical validity that’s equivalent or superior to tissue-based testing or another already-accepted test for the same biomarker for the same intended use.

  1. Tissue-Based Alternatives Not Feasible

In addition to these criteria, CTC testing is covered under the LCD only if:

  • Tissue-based testing for the biomarker in question is infeasible;
  • Repeat biopsy is medically contraindicated; or
  • Tissue testing won’t provide information sufficient for subsequent medical management, e.g., in cases where HER2 overexpression is negative in a tissue biopsy but may be positive in CTCs, due to tumor heterogeneity.

Takeaway

Biocept said its Target Selector CTC HER2 test has passed the CMS technology review, required by the second criterion. And because HER2 testing is a mainstay of precision oncology and mandated by professional guidelines for all patients with new primary or newly metastatic breast cancer, Medicare should cover the assay when used for individual cases that meet the LCD criteria, including those relating to the unavailability of testing on tissue samples.

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