FDA Cleared or Approved Companion Diagnostic Testing – Commercial and Individual Exchange Medical Policyopen_in_new

UnitedHealthcare covers FDA-cleared or -approved companion diagnostic (CDx) tests only when the test and biomarker match the FDA List of Cleared or Approved Companion Diagnostic Devices and the test use aligns with the drug’s FDA indication/label and specimen type; tests not on that FDA CDx list are excluded and handled under other molecular oncology policies. Coverage requires documentation that the CDx matches the FDA list and drug label, allows repeat CDx testing up to three times per year for therapy selection with documented recurrence/progression or treatment failure, permits concurrent tissue and liquid CDx within 30 days only for stage IV breast cancer or stage IV non‑small cell lung cancer, and is subject to member‑specific benefit terms and applicable mandates.

"For concurrent tissue-based and liquid biopsy testing (to be considered proven/medically necessary): documentation that the cancer type is advanced or metastatic (stage IV) breast cancer or advance..."