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Medical Policy: 02.04.16
Original Effective Date: March 2008
Reviewed: January 2012
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Studies have suggested that the presence of circulating tumor cells in patients with metastatic carcinoma is associated with short survival. Quantifying circulating tumor cells might be a useful technique to provide an immediate assessment of response to chemotherapy rather than relying on changes in imaging studies. Also, the presence of circulating tumor cells has been investigated as an additional prognostic factor in women with breast cancer without metastases which could be used to determine the need for additional adjuvant chemotherapy.
Research over more than 10 years has focused the development of methodologies with improved sensitivity and specificity. Physical techniques such as size filtration, density gradient centrifugation, and microscopic morphology continue to be used. However, biological techniques such as immunomagnetic isolation, flow cytometry, immunofluorescent microscopy, reverse transcriptase-polymerase chain reaction (RT-PCR), polymerase chain reaction (PCR), and fluorescence in situ hybridization (FISH) have been added to provide required specificity.
The CellSearch™ system (Veridex) is an example of immunofluorescent technology. The technique involves identification of the circulating tumor cells in blood which are tagged using antibody-coated magnetic beads that recognize cell surface antigens. The cells are then labeled with fluorescent dyes, which can then be quantified by a semiautomated fluorescent-based microscopy system.
The CellSearch™ system (Veridex) has received U.S. Food and Drug Administration (FDA) marketing clearance through the 510(k) process for monitoring metastatic breast cancer (January 2004), for monitoring metastatic colorectal cancer (November 2007), and for monitoring metastatic prostate cancer (February 2008). Veridex LLC, a Johnson & Johnson company, markets the CellSearch™ system. It uses automated instruments manufactured by Immunicon Corp. for sample preparation (Cell Tracks® AutoPrep) and analysis (CellSpotterAnalyzer®), together with supplies, reagents, and epithelial cell control kits manufactured by Veridex.
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Prior Approval:
Not applicable
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Policy:
Detection and quantification of circulating tumor cells is considered investigational in the management of patients with cancer.
While levels of circulating tumor cells may be associated with the presence of metastatic disease and prognosis, the prospective use of this information to impact care has not been demonstrated. Given the insufficient evidence to evaluate the impact on net health outcomes, the assessment of circulating tumor cells is investigational for the management of cancer.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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S3711 Circulating tumor cell test
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Selected References:
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Cristofanilli M, Budd GT, Ellis MJ et al. Circulating tumor cells, disease progression and survival in metastatic breast cancer. NEJM 2004; 351:781-91.
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Harris L, Fritsche H, Mennel R et al. American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer. J Clin Oncol. 2007 Nov 20;25(33):5287-312.
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Budd GT, Cristofanilli M, Ellis MJ et al. Circulating tumor cells versus imaging-predicting overall survival in metastatic breast cancer. Clin Cancer Res. 2006 Nov 1;12(21):6321-2.
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Hayes DF, Cristofanilli M, Budd GT et al. Circulating tumor cells at each follow-up time point during therapy of metastatic breast cancer patients predicts progression-free and overall survival. Clin Cancer Res. 2006 Jul 15;12(14 Pt 1):4218-24.
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Liu MC, Shields PG, Warren RD et al. Circulating Tumor Cells: A Useful Predictor of Treatment Efficacy in Metastatic Breast Cancer. J Clin Oncol. 2009 Sep 14. [Epub ahead of print]
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Cohen SJ, Punt CJA, Iannotti N et al. Relationship of Circuating Tumor Cells to Tumor Response, Progression-Free Survival, and Overall Survival in Patients with Metastatic Colorectal Cancer. J Clin Oncol. 2008 Jul 1; 26(19): 3213-3221.
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Serrano Fernadez MJ, Alvarez Merino JC, Martinez Zubiaurre I et al. Clinical relevance associated to the analysis of circulating tumour cells in patients with solid tumours. Clin Transl Oncol. 2009 Oct; 11(10):659-68.
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Gazzaniga P, Naso G, Gradilone A et al. Chemosensitivity profile assay of circulating cancer cells (CTCs): prognostic and predictive value in epithelial tumors. In J Cancer. 2009 Oct 9. [Epub ahead of print]
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Nakamura S, Yagata H, Ohno S et al. Multi-center study evaluating circulating tumor cells as a surrogate for response to treatment and overall survival in metastatic breast cancer. Breast Cancer. 2009 Aug 1. [Epub ahead of print]
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Mostert B, Sleijfer S, Foekens JA et al. Circulating tumor cells (CTCs): detection methods and their clinical relevance in breast cancer. Cancer treat Rev. 2009 Aug; 35(5): 463-74.
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Helo P, Cronin AM, Danila DC et al. Circulating prostate tumor cells detected by reverse transcription-PCR in men with localized or castration-refractory prostate cancer: concordance with CellSearch assay and association with bone metastases and with survival. Clin Chem. 2009 Apr;55(4):765-73.
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Iinuma H, Watanabe T, Mimori K et al. Clinical significance of circulating tumor cells, including cancer stem-like cells, in peripheral blood for recurrence and prognosis in patients with Dukes’ Stage B and C colorectal cancer. J Clin Oncol 2011 Apr 20; 29(12): 1547-55. Epub 2011 Mar 21.
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Krebs MG, Sloane R, Priest L et al. Evaluation and prognostic significance of circulating tumor cells in patients with non-small-cell lung cancer. J Clin Oncol 2011 Apr 20; 29(12): 1556-63. Epub 2011 Mar 21.
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Tanaka F, Yoneda K, Kondo N et al. Circulating tumor cells as a diagnostic marker in primary lung cancer. Clin Cancer Res 2009; 15(22):6980-6.
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Policy History:
Date Reason Action
January 2011 Annual review Policy renewed
January 2012 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
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