MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer

Molecular diagnostic tests for bladder cancer are covered when the beneficiary is actively managed for bladder cancer, the test was developed for the beneficiary's indication, the lab discloses appropriate indications, and either (a) multiple guideline-based treatment options require a physician–patient choice or (b) the test predicts response to a specific accepted therapy per national consensus guidelines. Additional requirements include analytical and clinical validation (including external algorithm validation if applicable), demonstration of clinical utility, completion of the MolDX technical assessment, and, for NGS tests, fulfillment of NCD 90.2 (advanced cancer, planned treatment, and not previously tested for the same genetic content). 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."