Does Not Apply to Commercial Genetic Testing Program effective 6/1/2018
Expanded molecular or genetic panel testing has been proposed as a method to evaluate many genetic markers at a single time to identify chemotherapeutic agents that target specific pathways when the individual has failed to respond to standard therapy. This comprehensive genomic profiling is recommended for individuals with non-small cell lung cancer to identify rare driver mutations to ensure these individuals receive the most appropriate treatment. There are a wide variety of commercially available expanded panel kits available. The following list contains examples of expanded genetic panels:
FoundationOne®CDx analyzes 236 cancer-related solid tumor genes (e.g. lung, breast, colon, gastrointestinal, pancreatic, head and neck, ovarian, or thyroid cancers
FoundationOne® Heme test analyzes 406 hematologic cancer-related genes
OnkoMatch™ detects 68 genetic mutations associated with solid tumors
GeneTrails™ Solid Tumor Panel analyses 37 genes mutations in solid tumors
SmartGenomics™ analysis of 62 cancer-associated genes for hematologic cancers and solid tumors
Guardant360® panel analyzes 68 genes associated with solid tumors
Caris Life Sciences offers individual tumor profiling services that analyzes of up to 56 tumor-associated genes
Paradigm Cancer Diagnostic (PcDx™) Panel
The use of expanded cancer mutation panels or broad molecular profiling for selecting targeted cancer treatment is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
The use of expanded cancer mutation panels or broad molecular profiling for selecting targeted cancer treatment for all other indications is considered investigational.
Molecular testing using expanded cancer mutation panels or broad molecular profiling is considered medically appropriate if ALL the following are met:
Individual has diagnosis of non-small cell lung cancer
The expanded panel test must include the EGFR, ALK, ROS1, and BRAF mutation testing
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
American Society of Clinical Oncology. (2018). Molecular testing guideline for the selection of patients with lung cancer for treatment with targeted tyrosine kinase inhibitors: American Society of Clinical Oncology endorsement of the College of American Pathologists/International Association for the study of lung cancer/Association for Molecular pathology clinical practice guideline update. Retrieved December 11, 2018 from www.asco.org.
BlueCross BlueShield Association. Evidence Positioning System. (11:2020). Comprehensive genomic profiling for selecting targeted cancer therapies (2.04.115). Retrieved June 11, 2021 from https://www.evidencepositioningsystem/. (32 articles and/or guidelines reviewed)
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2020, March). Next generation sequencing for solid tumors. (LCD ID L38045). Retrieved June 11, 2021 from https://www.cms.gov.
Johnson, D., Dahlman, K., Knol, J., Puzanov, I., Means-Powell, J., et al. (2014) Enabling a genetically informed approach to cancer medicine: a retrospective evaluation of the impact of comprehensive tumor profiling using a targeted next-generation sequencing panel. The Oncologist, (19), 616-622. (Level 4 evidence)
National Comprehensive Cancer Network. (2021, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Non-small cell lung cancer V4.2021. Retrieved June 11, 2021 from the National Comprehensive Cancer Network.
Taylor-Weiner, A., Zack, T., O’Donnell, E., Guerriero, J., Bernard, B., Reddy, A., et al. (2016). Genomic evolution and chemoresistance in germ-cell tumours. Nature, 540 (7631), 114-118. (Level 4 evidence)
ORIGINAL EFFECTIVE DATE: 12/13/2014
MOST RECENT REVIEW DATE: 8/12/2021
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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