Circulating Tumor DNA and Circulating Tumor Cells for Management (Liquid Biopsy) of Solid Tumor Cancers
Effective date
Oct 1, 2026
Identified
Jul 7, 2026
Summary
Cell-free tumor DNA testing in blood for targeted treatment selection is considered medically necessary when either advanced or metastatic ER-positive, HER2-negative breast cancer is present, or when clinical documentation shows tissue-based testing cannot be performed and the test includes at least one gene with an FDA-approved targeted therapy for that cancer indication. Cell-free DNA testing for targeted treatment selection is investigational when those criteria are not met, including urine tests. Cell-free DNA and circulating tumor cell testing for all other solid tumor indications, including measurable residual disease testing and cancer screening in asymptomatic individuals, is considered investigational.
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01Already effective October 1, 2026: Before requesting review of cell-free DNA testing for targeted treatment selection, submit all of the following: the name of the genetic test or panel and the performing laboratory; the exact genes or variants being tested, if applicable; the relevant billing codes; a brief description of why tumor tissue testing is not possible; the name of the medications under consideration that require genetic testing; and medical records related to the indication for testing, showing the cancer type and treatments received.
02If any of these items are not submitted, it could impact the review and decision outcome.
03Code 0585U is marked as deleted 10/01/2026.
Codes mentioned
8146281463814648615286153
Original notice
Circulating Tumor DNA and Circulating Tumor Cells for Management (Liquid Biopsy) of Solid Tumor Cancers
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