This policy version was replaced on January 4, 2021. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).
This policy addresses use of expanded molecular panels that may include a variety of genetic tumor markers including single nucleotide variants (SNVs) inversions and deletions (indels) and gene rearrangements. Molecular panel testing utilizes multiplex or next generation sequencing (NGS) that can rapidly assess a large number of genes.
Currently, there are a small number of individual genetic markers identified in clinical trials that have a direct impact on care for a specific cancer. In some cases, limited panels may be offered that are specific to one type of cancer. Specimens used in expanded panels include solid tumor tissue or plasma in which cell-free circulating tumor DNA (ctDNA) may be analyzed. Testing of ctDNA is also called “liquid biopsy.” Use of expanded molecular panels has been proposed to screen for cancer, and in cancer patients to determine prognosis, select targeted therapies, predict risk of recurrence, detect early relapse and monitor response to treatment. Testing of other bodily fluids, such as urine, saliva and cerebrospinal fluid as sources of ctDNA is under study.
Expanded panels using tumor tissue have received U.S. Food and Drug Administration (FDA) approval. These include the Oncomine™ Dx Target Test to detect the presence of BRAF, ROS1, and EGFR variants in tumor tissue of patients with metastatic non-small cell lung cancer (NSCLC). The test was approved as a companion diagnostic to select patients with NSCLC for combination therapy with dabrafenib and trametinib. FoundationOne CDx™, a panel of 324 genes and two genomic signatures, received FDA approval for solid tumor testing as a companion diagnostic to identify patients with certain genetic mutations who may benefit from FDA-approved treatments for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer.
Clinical laboratories may also develop and validate tests in-house and market them as a laboratory service. The laboratory offering the service must be licensed by Clinical Laboratory Improvement Amendments (CLIA) for high-complexity testing. Available ctDNA tests include, but are not limited to Biocept Liquid Biopsy, CancerIntercept Detect, Guardant360®, OncInsights™, OnkoMatch, and NeoLAB Prostate Liquid Biopsy.
NOTE: Testing of Circulating Tumor Cells is addressed in policy VI-25.
I. Selection of Targeted Therapy for Patients with Metastatic Non-Small Cell Lung Cancer
Expanded molecular panel testing using tumor tissue samples OR plasma genotyping (i.e., liquid biopsy) may be considered MEDICALLY NECESSARY AND APPROPRIATE for selection of targeted therapy in patients with metastatic non-small cell lung cancer.
II. Other Uses of Expanded Molecular Panel Testing of Solid Tumors
Expanded molecular panel testing of solid tumors using tumor tissue samples OR plasma genotyping (i.e. liquid biopsy) is considered EXPERIMENTAL/INVESTIGATIVE for all other uses due to a lack of evidence demonstrating an impact on improved health outcomes.
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Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies.
Medicaid products and some self-insured plans may have additional policies and prior authorization requirements. As applicable, review the provisions relating to a specific coverage determination, including exclusions and limitations. Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
For Medicare NCD and/or Medicare LCD, please consult CMS or National Government Services websites.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and /or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only, and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.