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DESCRIPTIONThe 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 short 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, which could be used to determine the need for additional adjuvant chemotherapy.
Research over the past 10 years 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 (RT-PCR), polymerase chain reaction (PCR), and fluorescence in site 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.
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. The technology has received U.S. Food and Drug Administration (FDA) 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). 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. As of April 2010, this remains the only FDA-cleared system for assessing circulating tumor cells.
This policy does not address techniques for the detection of disseminated tumor cells, e.g., in bone marrow.
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 service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
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.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.04.37
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.