Detection and Quantification of Circulating Tumor Cells in the Management of Patients with Cancer

Medical Policy: 02.04.16 
Original Effective Date: March 2008 
Reviewed:  
Revised:  

This policy applies to all products unless specific contract limitations, exclusions or exceptions apply. Please refer to the member's coverage manual for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply.

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.

The Cell Search System™ (Veridex) is an example of such a technology. The technique involves identification of the circulating tumor cells, 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 fluorescence-based microscopy system.

The number of circulating tumor cells has been associated with prognosis in patients with metastatic breast cancer. However, predicting risk or prognosis does not directly improve health outcomes. To complete the causal chain, there must be evidence that patient management decisions based on risk level or prognosis increase the duration or quality of life or decrease adverse events. Evidence is lacking that treatment decisions based on the number of circulating tumor cells improves outcomes for patients with metastatic breast cancer at this time.

Policy: 

Detection and quantification of circulating tumor cells is considered investigational in the management of patients with cancer.


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Procedure Codes and Billing Guidelines: 

  • To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
  • CPT 88399 Unlisted surgical pathology procedure

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Selected References: 

  • Cristofanilli M, Budd GT, Ellis MJ et al. Circulating tumor cells, disease progression and survival in metastatic breast cancer. NEJM 2004; 351:781-91.
  • 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.
  • 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.
  • 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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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:

Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309

*Current Procedural Terminology © 2009 American Medical Association. All Rights Reserved.



Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.