MolDX: Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer

Jurisdiction: J8 MAC Part B. States: Indiana, Michigan. Type: Active LCD

This policy describes and clarifies coverage for molecular or proteomic panel tests for Non -Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer. The determination outlines the medical necessity, indications, limitations, and required documentation for biomarker testing to ensure appropriate patient selection and effective utilization. Criteria for Coverage Non -Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer are covered when ALL of the following are met: The patient has a diagnosis of cancer, for which molecular testing of the tumor will inform treatment. At least 1 of the following is true: Testing by next-generation sequencing (NGS) is not feasible or will likely fail based on specimen type or tumor content. NGS is not required by national consensus guidelines to inform medical management decisions AND testing by a non-NGS method will provide a rapid result that allows for the prompt and timely management of the patient. The test accurately identifies known, common, and necessary predictive and actionable biomarkers that can safely preclude unnecessary NGS testing, reducing NGS use in patients for whom the treatment plan would not likely be altered. The patient has not been previously tested by a molecular panel test for the same cancer indication for the same genetic content. NOTE: A negative result (no clinically actionable mutations found) by the non-NGS test may be followed by an NGS test that includes additional necessary non-duplicative genes and genomic positions. The test accurately detects the most common genes and genomic positions required for the identification of clinically relevant FDA-approved therapies with a companion diagnostic biomarker for the given cancer type. The test has been validated in the intended-use population and with the intended-use sample types. The test demonstrates accuracy for measured analytes comparable to NGS testing, with superior turnaround times less than the ASCO-recommended 10 business days from sample acquisition. The test has satisfactorily completed a Technical Assessment (TA) by the Molecular Diagnostic Services Program (MolDX ® ) to ensure analytical validity (AV), clinical validity (CV) and clinical utility (CU) standards are met. Clinical validity (CV) of any analytes or profiles must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population with demonstrated reproducibility across clinical study cohorts. If the test relies on an algorithm, the algorithm must be validated in a cohort that is not a development cohort for the algorithm. Tests utilizing a similar methodology or evaluating a similar analyte(s) to a test for which existing coverage has been established must demonstrate equivalent or superior test performance (i.e., sensitivity and/or specificity) when used for the same indication in the same intended use population. Notes: Reference to specific tests in this LCD does not automatically imply coverage. NGS-based panel tests must fulfill criteria outlined in LCDs L38158, MolDX: Next-Generation Sequencing for Solid Tumors and L38176, MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies . Non-NGS-based tests for the diagnosis of BCR-ABL-negative myeloproliferative neoplasms must fulfill criteria outlined in L40022, MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms