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Policy Name: Liquid Biopsy: Testing of Circulating Tumor Cells Or Cell-Free Tumor DNA Effective Date: 7/16/2018

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Policy Name: Liquid Biopsy: Testing of Circulating Tumor Cells Or Cell-Free Tumor DNA Effective Date: 7/16/2018 Medica Coverage Policy Policy Name: Liquid Biopsy: Testing of Circulating Tumor Cells or Cell-Free Tumor DNA Effective Date: 7/16/2018 Important Information – Please Read Before Using This Policy These services may or may not be covered by all Medica plans. Please refer to the member’s plan document for specific coverage information. If there is a difference between this general information and the member’s plan document, the member’s plan document will be used to determine coverage. With respect to Medicare and Minnesota Health Care Programs, this policy will apply unless those programs require different coverage. Members may contact Medica Customer Service at the phone number listed on their member identification card to discuss their benefits more specifically. Providers with questions about this Medica coverage policy may call the Medica Provider Service Center toll-free at 1-800-458-5512. Medica coverage policies are not medical advice. Members should consult with appropriate health care providers to obtain needed medical advice, care and treatment. Coverage Policy Testing of circulating tumor cells (CTC) or cell-free DNA (cfDNA) is investigative and unproven, and therefore NOT COVERED. There is insufficient reliable evidence in the form of high quality peer-reviewed medical literature to establish the efficacy or effects on health care outcomes. Note: Pharmacogenetic testing IS COVERED when testing for a specific gene biomarker is required by the U.S. Food and Drug Administration (FDA) prior to initiating drug therapy. A list of FDA required tests (by test name and manufacturer) can be found on the FDA’s site, List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools), located at: https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or- approved-companion-diagnostic-devices-vitro-and-imaging-tools. Description Liquid biopsy is a test generally done on a sample of blood to look for cancer cells from a tumor that are circulating in the blood or for pieces of DNA from tumor cells that are in the blood. The term liquid biopsy can be used for any type of specimen other than tissue - including blood, urine, cerebral spinal fluid, as well as bone marrow. A liquid biopsy may be used to help find cancer at an early stage. It may also be used to help plan and monitor treatment or determine recurrence. It is purported that being able to take multiple samples of blood over time, aids in understanding the kinds of molecular changes occurring. Liquid biopsies may identify two main biomarkers in individuals with cancer: Cell-free DNA (cfDNA), also known as circulating tumor DNA (ctDNA). Cell-free DNA are small DNA fragments that are shed by the tumor into the bloodstream. Circulating tumor cells (CTCs). Circulating tumor cells are cancer cells that detach from the tumor and travel through the bloodstream or lymphatic system to other parts of the body. The major difference is that cell-free DNA is greater than 100 times more abundant in the bloodstream than CTCs. In a 10mL blood sample, you may only find a handful of CTCs at most, whereas with cell-free DNA, there are tens to hundreds of genome equivalents that make it easier to test. Liquid Biopsy: Testing of Circulating Tumor Cells or Cell-Free Tumor DNA Page 1 of 3 Medica Coverage Policy FDA Approval Laboratory tests are regulated under the Clinical Laboratory Improvement Amendments (CLIA) Act of 1988. Premarket approval from the FDA is not required as long as the assay is performed in a laboratory facility that observes CLIA regulations and the assay is not marketed for general use. CTC Test: CellSearch System™ (Veridex LLC) is the only FDA-approved test for CTC assessment. CellSearch received FDA 510(k) Premarket Notification approval for evaluating circulating tumor cells resulting from metastatic breast cancer, metastatic colorectal cancer and metastatic prostate cancer. Examples of additional CTC tests include, but are not limited to: AdnaTest BreastCancer® (AdnaGen AG, OncoVista, Inc.) and The OncoQuick™ (Greiner Bio-One, Inc.). Currently, these tests have not received FDA approval. cfDNA Test: No cfDNA test has been FDA approved. Examples of cfDNA tests include, but are not limited to: Guardant360, Pathway Genomics’ CancerIntercept™, cobas EGFR Mutation Test v2, Epic AR-V7, FoundationACT, GeneStrat, and OncotypeSEQ. Prior Authorization Prior authorization is not applicable. Claims for this service are subject to retrospective review and denial of coverage, as investigative services are not eligible for reimbursement. Coding Considerations Use the current applicable CPT/HCPCS code(s). The following codes are included below 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. CPT/HCPC Codes: 86152 - Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood); 86153 - Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood); physician interpretation and report, when required 0023U - Oncology (acute myelogenous leukemia), DNA, genotyping of internal tandem duplication, p.D835, p.I836, using mononuclear cells, reported as detection or non-detection of FLT3 mutation and indication for or against the use of midostaurin 0091U - Oncology (colorectal) screening, cell enumeration of circulating tumor cells, utilizing whole blood, algorithm, for the presence of adenoma or cancer, reported as a positive or negative result 0118U - Transplantation medicine, quantification of donor-derived cell-free DNA using whole genome next- generation sequencing, plasma, reported as percentage of donor-derived cell-free DNA in the total cell-free DNA. 0177U – Oncology (breast cancer), DNA, PIC3CA (phosphatidylinositol-4, 5-bisphosphate 3-kinase catalytic subunit alpha) gene analysis of 11 gene variants utilizing plasma, reported as PIK3CA gene mutation status 0179U – Oncology (non-small cell lung cancer), cell-free DNA, targeted sequence analysis of 23 genes (single nucleotide variations, insertions and deletions, fusions without prior knowledge of partner/breakpoint, copy number variations), with report of significant mutation(s) 0229U - BCAT1 (Branched chain amino acid transaminase 1) or IKZF1 (IKAROS family zinc finger 1) (eg, colorectal cancer) promoter methylation analysis 0239U - Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free DNA, analysis of 311 or more genes, interrogation for sequence variants, including substitutions, insertions, deletions, select rearrangements, and copy number variations Liquid Biopsy: Testing of Circulating Tumor Cells or Cell-Free Tumor DNA Page 2 of 3 Medica Coverage Policy Original Effective Date: 1/1/2012 Re-Review Date(s): 1/1/2015 10/1/2017 – administrative update; code added 5/16/2018 2/17/2020 – administrative update; format 6/29/2020 – administrative update; FDA link added 7/1/2020 – administrative update; codes added 1/1/2021 – administrative update; code update © 2012 – 2021 Medica. Medica® is a registered service mark of Medica Health Plans. “Medica” refers to the family of health services companies that includes Medica Health Plans, Medica Community Health Plan, Medica Insurance Company, Medica Self-Insured, MMSI, Inc. d/b/a Medica Health Plan Solutions, Medica Health Management, LLC and the Medica Foundation. Liquid Biopsy: Testing of Circulating Tumor Cells or Cell-Free Tumor DNA Page 3 of 3 .
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