MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer

Summary of Evidence Analysis of Evidence General Information Associated Information Sources of Information Bibliography Revision History Information Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Versions Keywords Local Coverage Determination (LCD) MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer L38576 Expand All | Collapse All  Email Document  Download  Add to basket Contractor Information Contractor Name Contract Type Contract Number Jurisdiction States LCD Information Document Information LCD ID L38576 LCD Title MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer Proposed LCD in Comment Period N/A Source Proposed LCD DL38576 Original Effective Date For services performed on or after 07/18/2021 Revision Effective Date For services performed on or after 07/03/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 06/22/2023 Notice Period End Date 08/05/2023 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee sched

This contractor will cover molecular diagnostic tests for use in a beneficiary with bladder cancer when all of the following conditions are met: The beneficiary is being actively managed for bladder cancer. The beneficiary is within the population and has the indication for which the test was developed and is covered. The laboratory will make available the appropriate indications of the test to the treating/ordering physician. At least 1 of the 2 criteria are met: The patient is a candidate for multiple potential treatments, which could be considered to have varied or increasing levels of intensity based on a consensus guideline, and the physician and patient must decide among these treatments. OR The patient is a candidate for multiple therapies, and the test has shown that it predicts response to a specific therapy among accepted therapy options based on nationally recognized society consensus guidelines (i.e., National Comprehensive Cancer Network [NCCN], American Society of Clinical Oncology [ASCO], Society of Urologic Oncology [SUO], or American Urological Association [AUA]). If Next-Generation Sequencing (NGS) methodology is used in testing, the conditions set by NCD 90.2 are fulfilled (summarized: the patient has advanced cancer; plans on being treated for said cancer, and has not been previously tested with the same test for the same genetic content) The test demonstrates analytical validity including both analytical and clinical validations. If the test relies on an algorithm (which may range in complexity from a threshold determination of a single numeric value to a complex mathematical or computational function), the algorithm must be validated in a cohort that is not a development cohort for the algorithm. The test has demonstrated clinical validity and utility , establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision (in 4. above) in a clearly defined population. The test successfully completes a Molecular Diagnostic Services Program (MolDX ® ) technical assessment that ensures the test is reasonable and necessary as described above. Only 1 test may be performed prior to the initiation of therapy UNLESS a second test that interrogates different genomic content AND meets all the criteria established herein, is reasonable and necessary. The genomic content interrogated by the test must be relevant to the therapy under consideration.