MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer

MolDX covers prognostic and predictive molecular diagnostic tests for beneficiaries with bladder cancer who are actively managed and used within the population/indication for which the test was developed. Coverage requires either that testing informs a decision among multiple treatment intensities or predicts response to a specific accepted therapy per national society guidelines, plus demonstration of analytical and clinical validation, independent algorithm validation (if applicable), relevance of genomic content to the therapy, completion of MolDX technical assessment, and compliance with NCD 90.2 when NGS is used; only one test is allowed prior to therapy unless a second test interrogates different genomic content and meets all criteria.

"Beneficiary is being actively managed for bladder cancer at the time of testing."

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