MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer

MolDX covers molecular diagnostic tests for beneficiaries actively managed for bladder cancer when the test is developed for the patient's indicated population and the laboratory communicates appropriate indications. Coverage requires that the test influences a treatment decision among multiple accepted options (per consensus guidelines) or predicts response to a specific therapy, demonstrates analytical and clinical validity and utility (including independent algorithm validation if applicable), completes the MolDX technical assessment, and adheres to NCD 90.2 when NGS is used; only one pre-therapy test is allowed unless a second test interrogates different genomic content and meets all criteria.

"Beneficiary is being actively managed for bladder cancer."

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