Medical Policy: 02.04.16 

Original Effective Date: March 2008 

Reviewed: September 2017 

Revised: November 2014 

 

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:

The prognosis of cancer patients is often determined by the occurrence of metastatic disease. Studies have suggested that the presence of circulating tumor cells (CTCs) in patients with metastatic carcinoma is associated with shortened 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 and guiding cancer therapy.

Intact circulating tumor cells (CTCs) are released from a primary tumor and/or metastatic site into the bloodstream. The half-life of a CTC in the bloodstream is short (1-2 hours), and CTCs are cleared through extravasation into secondary organs. Most assays detect CTCs through the use of surface epithelial markers such as EpCAM and cytokeratins. The primary reason for detecting CTCs is prognostic, through quantification of circulating levels which could potentially provide information that could guide treatment decisions or aid in the monitoring of response to treatment. CTCs have been documented in multiple tumor types, such as breast, prostate, lung and colorectal carcinomas; the largest body of data comes from studies of geno typical 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. Circulating tumor cells potentially offer a noninvasive alternative to tissue biopsy.

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.

 

Examples of Circulating Tumor Cells (CTCs) Tests 

CellSearch 

The CellSearch™ system (Janssen Diagnostics, formerly Veridex) is an example of immunofluorescent technology. The technique involves identification of the circulating tumor cells (CTCs) (cancer cells that detach from the primary tumor and travel through the bloodstream or lymphatic system to other parts of the body) in the peripheral 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 is the only FDA approved device for monitoring patients with metastatic disease (breast, colon and prostate cancer) and circulating tumor cells. The CellSearch circulating tumor cell test is utilized to assist clinicians (oncologists) to assess the prognosis of their patients, changes in CTCs are predictive of disease progression among cancer patients receiving chemotherapy. Serial testing for circulating tumor cells (CTCs) should be used in conjunction with other clinical methods for monitoring, such as imaging, lab tests, physical examination, and complete medical history to assess patient prognosis throughout the course of disease.

OncoCEE 

OncoCEE (Biocept, Inc) uses reagents and microfluidic chambers, Biocepts “cell enrichment and extraction” or CEE method captures circulating tumor cells from patient’s blood samples. The circulating tumor cells (CTCs) can then be analyzed by fluorescence in situ hybridization (FISH) probes or via quantitative PCR methods. OncoCEE is utilized to assist clinicians to assess the prognosis of their patients, changes in CTCs are predictive of disease progression among cancer patients receiving chemotherapy.

Summary 

For individuals who have cancer and receive identification and quantification of circulating tumor cells (CTCs), based on review of the peer reviewed medical literature, 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. The clinical utility of quantifying CTCs remains unproven at this time. Published data is inadequate to determine how such measurements should guide treatment decisions and whether those treatment decisions could result in beneficial outcomes. Further studies are needed to explore the clinical utility of circulating tumor cells (CTCs) in the management of patients with cancer. 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.

 

Practice Guidelines and Position Statements

American Society of Clinical Oncology (ASCO):

Recommendations for the use of tumor markers in breast cancer, published in 2007, indicate that the measurement of CTCs should not be used to make the diagnosis of breast cancer or to influence any treatment decisions in those with breast cancer. They should not be used in the prevention, screening, treatment, or surveillance of breast cancer.

In 2015, the American Society of Clinical Oncology (ASCO) updated their guideline, use of biomarkers to guide decisions on systemic therapy for women with metastatic breast cancer: American Society of Clinical Oncology Clinical Practice Guideline which states: “Recommendations for circulating tumor markers: In patients already receiving systemic therapy for metastatic breast cancer, decisions on changing to a new drug or regimen or discontinuing treatment should be based on clinical evaluation, judgment of disease progression or response, and the patient’s goals for care. There is no evidence at this time that changing therapy based solely on circulating biomarkers results improves health outcomes, quality of life or cost effectiveness.” (Type: evidence based. Evidence quality: intermediate. Strength of recommendation: moderate)

In 2016, the American Society of Clinical Oncology (ASCO) issued a guideline, use of biomarkers to guide decisions on adjuvant systemic therapy for women with early stage invasive breast cancer which states: “The clinician should not use circulating tumor cells to guide decisions on adjuvant systemic therapy.” Type: Evidence based; Evidence quality: Intermediate; Strength of recommendation: strong 

Clinical interpretation of literature review: circulating tumor cells have been shown to have prognostic value in breast cancer; however, no data are available that demonstrate that circulating tumor cell based tests have clinical utility. 

In 2017,  the American Society of Clinical Oncology (ASCO) issued a focused update on the use of biomarkers to guide decisions and adjuvant systemic therapy for women with early stage invasive breast cancer which included the following recommendation: “The clinician should not use CTCs to guide decisions for adjuvant systemic therapy.” (Type: Evidence based; Evidence quality: Intermediate; Strength of recommendation: Strong) 

 

National Comprehensive Care Network (NCCN)

Breast Cancer Version 2.2017

Discussion Section: Monitoring Metastatic Disease: The clinical use of circulating tumor cells (CTC) in metastatic breast cancer is not yet included in the NCCN guidelines for Breast Cancer for disease assessment and monitoring. Patients with persistently increased CTC after 3 weeks of first line chemotherapy have a poor PFS (progressive free survival) and OS (overall survival). In spite of its prognostic ability, CTC count has failed to show a predictive value. A prospective, randomized phase 3 trials (SWOG S0500) evaluated the clinical utility of serial enumeration of CTC in patients with metastatic breast cancer. According to the study results, switching to an alternative cytotoxic therapy after 3 weeks of first line chemotherapy in patients with persistently increased CTC did not affect either PFS (progressive free survival) or OS (overall survival). 

Colon Cancer Version 2.2017

The clinical use of circulating tumor cells (CTC) in colon cancer is not yet included in the NCCN guidelines for disease assessment and monitoring. 

Prostate Cancer Version 2.2017

The clinical use of circulating tumor cells (CTC) in prostate cancer is not yet included in the NCCN guidelines for disease assessment and monitoring. 

Non-Small Cell Lung Cancer Version 8.2017 

The clinical use of circulating tumor cells (CTC) in lung cancer is not yet included in the NCCN guidelines for disease assessment and monitoring.

 

National Academy of Clinical Biochemistry (NACB):

In 2009, NACB issued a guideline on the use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancer.

  • The panel concluded that the measurement of circulating prostate cancer cells was not sufficiently validated to recommend its application in routine clinical practice.
  • For breast cancer circulating tumor cells for assessing prognosis and monitoring therapy in advanced disease is undergoing evaluation and is available but not widely used in clinical practice. Prospective randomized trial underway. Level of evidence III (evidence from large prospective studies)
  • For testicular, colorectal and ovarian cancer – guidelines do not mention or indicate the use of circulating tumor cells.

Regulatory Status

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.

Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory developed tests (LDTs) must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments (CLIA). Laboratories that offer LDTs must be licensed by CLIA for high complexity testing. To date, the U.S. Food and Drug Administration (FDA) has chosen not to require any regulatory review of this test.

Biocept, Inc is CLIA certified laboratory testing company focused on the detection and analysis of circulating tumor cells (CTC) – OncoCEE.

 

Prior Approval:

 

Not applicable

 

Policy:

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

While levels of circulating tumor cells (CTCs) may be associated with the presence of metastatic disease and prognosis, the prospective use of this information to impact care has not been demonstrated. The clinical utility of quantifying CTCs remains unproven at this time. Published data is inadequate to determine how such measurements should guide treatment decisions and whether those treatment decisions could result in beneficial outcomes.  Further studies are needed to explore the clinical utility of circulating tumor cells (CTCs) in the management of patients with cancer.  Given the insufficient evidence to evaluate the impact on net health outcomes, the assessment of circulating tumor cells (CTCs) is investigational for the management of patients with cancer.

 

Procedure Codes and Billing Guidelines:

  • To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis 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.

 

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.
  • 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]
  • 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.
  • 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.
  • 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]
  • 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]
  • 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.
  • 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.
  • Ma J, Lin JY, Alloo A et al. Isolation of tumorigenic circulating melanoma cells. Biochem Biophys Res Comm. 2010 Nov 26;402(4):711-7. Epub 2010 Oct 25.
  • Riethdorf S, Pantel K. Advancing personalized cancer therapy by detection and characterization of circulating carcinoma cells. Ann N Y Acad Sci. 2010 Oct;12:66-77. doi:10.1111/j.1749-6632.2010.05779.x.
  • Munzone E, Nole F, Goldhirsch A et al. Changes of HER2 status in circulating tumor cells compared with the primary tumor during treatment for advanced breast cancer. Clin Breast Cancer. 2010 Oct 1;10(5):392-7.
  • Ali A, Furusato B, Ts’o PO et al. Assessment of circulating tumor cells (CTCs) in prostate cancer patients with low-volume tumors. Pathol Int 2010 Oct;60(10):667-72. doi:10.1111/j.1440-1827.2010.02584.x.
  • Xu X, Zhong JF. Circulating tumor cells and melanoma progression. J Invest Dermatol. 2010 Oct;130(10):2240-7.
  • Criscitiello C, Sotiriou C, Ignatiadis M. Circulating tumor cells and emerging blood biomarkers in breast cancer. Curr Opin Oncol. 2010 Nov;22(6):552-8.
  • 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.
  • 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.
  • 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.
  • Pierga JY, Hajage D, Bachelot T, Delaloge S, et al. High independent prognostic and predictive value of circulating tumor cells compared with serum tumor markers in a large prospective trial in first-line chemotherapy for metastatic breast cancer patients. Ann Oncol. 2012 Mar;23(3):618-24.
  • Zhang L, Riethdorf S, Wu G, Wang T, et al. Meta-analysis of the prognostic value of circulating tumor cells in breast cancer. Clin Cancer Res. 2012 Oct 15;18(20):5701-10.
  • American Society of Clinical Oncology (ASCO), American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer. Published in Journal of Clinical Oncology, Vol 25, Issue 33 (November), 2007: 5287-5312.
  • American Cancer Society What's New in Breast Cancer Research and Treatment?  New Laboratory Tests, Circulating Tumor Cells.
  • Canadian Agency for Drugs and Technologies in Health. The CellSearch System for Detecting Circulating Tumor Cells in Advanced Ovarian Cancer: Clinical Benefit and Cost Effectiveness. November 16, 2012.
  • Agency for Healthcare Research and Quality (AHRQ). Use of Tumor Markers in Testicular, Prostate, Colorectal, Breast and Ovarian Cancers. 2009.
  • British Journal of Cancer. A Direction Comparison of CellSearch and ISET for Circulating Tumor Cell Detection in Patients with Metastatic Carcinomas. September 6, 2011; 105(6): 847-853
  • UpToDate. Systemic Treatment for Metastatic Breast Cancer: General Principles. Daniel F. Hayes, M.D. Topic last updated August 21, 2017.
  • UpToDate. Prostate Cancer: Risk Stratification and Choice of Initial Treatment. Eric A. Klein, M.D. Topic last updated August 8, 2017.
  • National Comprehensive Cancer Network (NCCN): Version 2.2017 Breast Cancer
  • National Comprehensive Cancer Network (NCCN): Version 2.2017 Colon cancer
  • National Comprehensive Cancer Network (NCCN): Version 2.2017 Prostate Cancer
  • National Comprehensive Cancer Network (NCCN) Version 8.2017 Non-Small Cell Lung Cancer Version. 
  • National Academy of Clinical Biochemistry (NACB) The use of tumor markers in testicular, prostate, colorectal, breast and ovarian cancer. 2009. National Guideline Clearinghouse
  • UpToDate. Prognostic and Predictive Factors in Metastatic Breast Cancer, Stephen Chia, M.D., FRCPC, Topic last updated November 16, 2016.
  • UpToDate. Overview of the Treatment of Disseminated Prostate Cancer, Nancy A. Dawson, M.D., Topic last updated March 8, 2016.
  • American Society of Clinical Oncology (ASCO), Use of Biomarkers to Guide Decisions on Systemic Therapy for Women with Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline, Journal of Clinical Oncology, J Clin Oncol 33 2015.
  • UpToDate. Prognostic and Predictive Factors in Early, Non-Metastatic Breast Cancer, Theodoros Foukakis M.D., PhD, Jonas Bergh, M.D., PhD, FRCP. Topic last updated August 15, 2017.
  • Janssen Diagnostics. CellSearch. Also available at www/cellsearchctc.com
  • Harris L, Ismaila N, McShane L, et. al. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women and Early Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Journal of Clinical Oncology Volume 34, Number 10 Aprila 1, 2016
  • Huang X, Gao P, Song Y, et. al. Meta-analysis of the prognostic value of circulating tumor cells detected with CellSearch System in colorectal cancer. BMC Cancer. 2015;15:202. PMID 25880692
  • Bork U, Rahbari NN, Scholch S, et. al. Circulating tumor cells and outcome on non-metastatic colorectal cancer: a prospective study. Br J Cancer. Apr 14 2015;112(8):1306-1313. PMID 25867263
  • Okabe H, Tsunoda S, Hosogi H, et. al. Circulating tumor cells as an independent predictor of survival in advanced gastric cancer. Ann Surg Oncol. Mar 17 2015. PMID 25777087
  • Schulze K, Gash C, Staufer K, et. al. Presence of EpCAM-positive circulating tumor cells in advanced head and neck cancer using the CellSearch system. Had Nec. Oct 2012;34(10):1440-1444. PMID 22076949
  • Khoja L, Lorigan P, Zhou C, et. al. Biomarker utility of circulating tumor cells in metastatic cutaneous melanoma. J Invest Dermatol. Dec 6 2013;133(6):1582-1590. PMID 23223143
  • Smerage JB, Barlow WE, Hortobagyi GN, et. al. Circulating tumor cells and response to chemotherapy in metastatic breast cancer. SWOG S0500. J Clin Oncol. Nov 1 2014;32(31):3483-3489
  • Krop I, Ismaila N, Fabrice A, et. al. Use of Biomarkers to Guide Decisions and Adjuvant Systemic Therapy for Women with Early Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Focused Update. J Clin Oncol 2017 35:2838-2847
  • UpToDate. Overview of the Treatment of Castration-Resistant Prostate Cancer (CRPC) Nancy A. Dawson M.D.. Topic last updated July 19, 2017.
  • UpToDate. Initial Staging and Evaluation of Men with Newly Diagnosed Prostate Cancer. Philp W. Kantoff M.D., Mary-Ellen Taplin M.D., Joseph A. Smith M.D.. Topic last updated April 14, 2017.
  • Palmetto GBA OncoCee Coding and Billing Guidelines (M00036, V6).
  • Biocept Inc. Biocept Publishes on Mechanics and Performance of its OncoCEE platform for Circulating Tumor Cells (CTCs) in Cancer Patients. Sept 28, 2011.
  • CellSearch Circulating Tumor Cell Test.
  • Alix-Panabieres C, Pantel K, Clinical applications of circulating tumor cells and circulating tumor DNA as liquid biopsy. Cancer Discov. May 2016;6(5):479-491. PMID 26969689
  • Pailler E, Auger N, Lindsay CR, et. al. High level of chromosomal instability in circulating tumor cells of ROS1-rearranged non-small-cell lung cancer. Ann Oncol Jul 2015;26(7):1408-1415. PMID 25846554
  • Lyberopoulou A, Aravantinos G, Efstathopoulos EP, et. al. Mutational analysis of circulating tumor cells from colorectal cancer patients and correlation with primary tumor tissue. PLoS One 2015;10(4):e0123902. pMID 25902072
  • Zhang L, Riethdorf S, Wu G, et. al. Meta-analysis of the prognostic value of ciruculating tumor cells in breast cancer. Clin Cancer Res. Oct 15 2012;18(20):5701-5710. PMID 22908097
  • Zhao S, Liu Y, Zhang Q, et. al. The prognostic role of circulating tumor cells (CTCs) detected by RT-PCR in breast cancer; a meta-analysis of published literature. Breast Cancer Res Treat 2011; 130(3);809-816. PMID 21311967
  • Pierga JY, Hajage D, Bachelot T, et. al. High independent prognostic and predictive value of circulating tumor cells compared with serum tumor markers in a large prospective trial in first line chemotherapy for metastatic breast cancer patients. Ann Oncol. 2012;23(3-Jan):618-624. PMID 21642515
  • Ma X, Xiao Z, Li X, et. al. Prognostic role of circulating tumor cells and disseminated tumor cells in patients with prostate cancer: a systemic review and meta-analysis. Tumour Biol. 2014 Jun;35(6):5551-60 PMID 24563278
  • Groot Koerkamp B, Rahbari NN, Buchler MW, et. al. Circulating tumor cells and prognosis of patients with resectable colorectal liver metastases or widespread metastatic colorectal cancer: a meta-analysis. Ann Surg Oncol. Mar 2 2013;20(7):2156-2165. PMID 23456317
  • Seeberg LT, Waage A, Brunborg C, et. al. Circulating tumor cells in patients with colorectal liver metastasis predict impaired survival. Ann Surg 2015 Jan;261(1):164-71. PMID 24509211
  • Hirose T, Murata Y, Oki Y, et. al. Relationship of circulating tumor cells to the effectiveness of cytotoxic chemotherapy in patients with metastatic non-small cell lung cancer. Oncol Res 2012;20(2-3):131-137. PMID 231193919
  • Gazziniga P, de Berardinis E, Raimondi C, et. al. Circulating tumor cells detection has independent prognostic impact on high risk non-muscle invasive bladder cancer. Int J Cancer 2014 Oct 15;135(8):1978-82. PMID 24599551
  • Okabe H, Tsunoda S, Hosogi H, et. al. Circulating tumor cells as an independent predictor of survival in advanced gastric cancer. Ann Surg Oncol 2015 Nov 22;22(12):3954-61. PMID 25777087
  • Schulze K, Gasch C, Staufer K, et. al. Presence of EpCAM-positive circulating tumor cells as biomarker for systemic disease strongly correlates to survival in patients with hepatocellular carcinoma. Int J Cancer Nov 2013;133(9):2165-2171. PMID 23616258
  • Nichols AC, Lowes LE, Szeto CC, et. al. Detection of circulating tumor cells in advanced head and neck cancer using the CellSearch System. Head Neck Oct 2012;34(10):1440-1444. PMID 22076949

 

Policy History:

  • September 2017 - Annual Review, Policy Renewed
  • September 2016 - Annual Review, Policy Renewed
  • October 2015 - Annual Review, Policy Renewed
  • November 2014 - Annual Review, Policy Revised
  • January 2014 - Annual Review, Policy Renewed
  • January 2013 - Annual Review, Policy Renewed
  • January 2012 - Annual Review, Policy Renewed
  • January 2011 - Annual Review, Policy Renewed

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.

 

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