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The prognosis of cancer patients is often determined by the occurrence of metastatic disease. Studies have suggested that the presence of circulating tumor cells in patients with metastatic carcinoma is associated with shortened survival. The detection of circulating tumor cells might be useful for assessing prognosis and guiding cancer therapy.
Circulating tumor cells (CTCs) are malignant cells that are found in the peripheral blood and originate from primary or metastatic tumors. CTCs could potentially provide prognostic information that could guide treatment decisions or aid in the monitoring of response to treatment. Circulating tumor cells have been documented in multiple tumor types, such as breast, prostate, lung, and colorectal carcinomas; the largest body of data comes from studies of women with metastatic breast cancer. CTCs have also been investigated as an additional prognostic factor in non-metastatic breast cancer and could be used to determine the need for additional adjuvant chemotherapy.
Research has focused on 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, polymerase chain reaction, and fluorescence in site hybridization have been added to provide required specificity.
The CellSearch® System (Janssen Diagnostics) 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.
Note: This policy does not address techniques for the detection of bone marrow disseminated tumor cells or circulating cell-free DNA.
The CellSearch® System (Janssen Diagnostics, formerly 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). The system 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. FDA product code: NQI.
Related medical policies include Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer, Gene Based Test for Screening, Detection and/or Management of Prostate Cancer, and Biomarker Genes for the Detection of Lymph Node Metastases in Breast Cancer.
POLICYDetection and quantification of circulating tumor cells is considered investigational in the management of patients with cancer.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY3/31/2005: Approved by Medical Policy Advisory Committee (MPAC)
6/6/2005: Code Reference section completed
6/3/2009: Policy reviewed, no changes
06/07/2010: Policy description updated regarding research findings and testing technology; added links to related medical policies. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section.
07/29/2011: Policy reviewed; no changes.
06/06/2012: Added 0279T and 0280T to the Code Reference section.
12/21/2012: Added the following new 2013 CPT codes to the Code Reference section: 86152 and 86153.
08/14/2013: Policy reviewed; no changes.
08/04/2014: Policy reviewed; description updated. Policy statement unchanged. Removed deleted CPT codes 0279T and 0280T from the Code Reference section.
07/13/2015: Code Reference section updated for ICD-10.
10/30/2015: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.04.37
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.