Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms

Jurisdiction: J6 MAC Part B. States: Illinois, Minnesota, Wisconsin. Type: Active LCD

Non-Small Cell Lung Cancer (NSCLC) Indications and Limitations of Coverage Genomic Sequential Analysis Panel will be considered reasonable and necessary in the evaluation of tumor tissue in the following clinical circumstances: Newly diagnosed patients with advanced (stage IIIB or IV) NSCLC, who are not treatable by resection or radiation with curative intent, and who are suitable candidates for therapy at the time of testing. Previously diagnosed patients with advanced (stage IIIB or IV) NSCLC, who have not responded to at least one systemic therapy, or who have progressed following resection. The patient must be a candidate for treatment at the time of the testing. Previously diagnosed patients with advanced (stage IIIB or IV) NSCLC, who have been resistant to at least one targeted therapy, are able to undergo tumor tissue biopsy for testing, and who are suitable candidates for additional treatment at the time of testing. Metastatic Colorectal Cancer (mCRC) Indications and Limitations of Coverage Genomic Sequential Analysis Panel will be considered reasonable and necessary when the test is performed in a CLIA-certified laboratory qualified to perform high complexity testing, ordered by a treating physician, and the patient has: metastatic CRC; and is a candidate for intensive chemotherapy with an anti-EGFR biologic agent; and has not had prior RAS/BRAF testing (except after initiation of anti-EGFR therapy with evidence of acquired resistance). Next-Generation Sequence (NGS) Comprehensive Genomic Profile (CGP) Testing Indications and Limitations of Coverage This policy section describes coverage of NGS CGP diagnostic testing for patients with advanced cancer as allowable by a Medicare Administrative Contractor (MAC) under the National Coverage Determination (NCD) 90.2 (1). The policy scope is specific to solid tumors and exclusive of hematologic malignancies (the subject of separate LCD L37606), circulating tumor DNA testing (ctDNA), and other cancer-related uses of NGS, such as germline testing. CGP is a NGS approach that uses a single assay to assess hundreds of genes including relevant cancer biomarkers, with solid evidentiary support for clinical utility in guidelines and clinical trials. CGP assays include not only individual genetic variants (single nucleotide variants (SNVs), insertions/deletions (INDELs), copy number alterations (CNAs), structural variants (SVs), and splice-site variants), but also patterns of mutations such as DNA mismatch repair deficiency (dMMR), microsatellite instability (MSI), and total mutational burden (TMB). CGP testing may also include RNA sequencing to detect structural rearrangements, such as fusions/translocations and functional splicing mutations. CGP NGS testing for patients with advanced cancer is reasonable and necessary only when performed in a CLIA-certified laboratory, when ordered by a treating physician, and when the patient has: either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and not been previously tested with a CGP for the same cancer genetic content; and decided to seek further cancer treatment (e.g., therapeutic chemotherapy) Additionally, the test performed must be able to detect at least the minimum genes and genomic positions required for the identification of clinically supported, FDA-approved therapies. The genes and genomic positions required are listed in Category 1 or 2A of the most current version of the National Comprehensive Cancer Network (NCCN) Biomarkers Compendium (2). Testing assays must be FDA approved/cleared, or if a laboratory developed test (LDT), have a published, peer-reviewed study supporting analytic validity, or certification by a third-party consistent with the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) review standards.