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Serum Tumor Markers in the Management of Malignancies

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 02.01.20 
Original Effective Date: December 2000 
Reviewed: October 2014 
Revised: October 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: 

Tumor markers are substances normally produced in low quantities by cells in the body. Detection of a higher-than-normal serum level by radioimmunoassay or immunohistochemical techniques usually indicates the presence of a certain type of cancer.  Currently, the main use of tumor markers is to assess a cancer's response to treatment and to check for recurrence. In some types of cancer, tumor marker levels may reflect the extent or stage of the disease and can be useful in predicting how well the disease will respond to treatment.  A decrease or return to normal in the level of a tumor marker may indicate that the cancer has responded favorably to therapy.  If the tumor marker level rises, it may indicate that the cancer is spreading.  Finally, measurements of tumor marker levels may be used after treatment has ended as a part of follow-up care to check for recurrence.


However, in many cases the literature states that measurements of tumor marker levels alone are insufficient to diagnose cancer for the following reasons: (1) tumor marker levels can be elevated in people with benign conditions; (2) tumor marker levels are not elevated in every person with cancer, especially in the early stages of the disease; and (3) many tumor markers are not specific to a particular type of cancer; and (4) the level of a tumor marker can be elevated by more than one type of cancer.

 

Practice Guidelines and Position Statements

 

American Society of Clinical Oncology (ASCO) clinical practice guidelines

 

2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer
Different tumor markers are used at different points in the diagnosis and treatment process. ASCO recommends that the following tumor markers may be used in the following situations:

  • CA 15-3 and CA 27.29:
    • Data is insufficient to recommend CA 15-3 or CA 27.29 for screening, diagnosis and staging.
    • Data does not support the use of CA 15-3 or CA 27.29 for monitoring patients for recurrence after primary breast cancer therapy.
    • Monitoring patients with metastatic disease during active therapy, CA 27.29 or CA 15-3 can be used in conjunction with  the patient’s health history, a physical examination, and diagnostic imaging.
    • Data is insufficient to recommend the use of CA 15-3 or CA 27.29 for monitoring response to treatment. However, in the absence of readily measurable disease, an increasing CA 15-3 or CA 27.29 may be used to indicate treatment failure.
  • CEA:
    • CEA is not recommended for screening, diagnosis, staging or routine surveillance of breast cancer patients after primary therapy.
    • CEA is used for monitoring patients with metastatic disease during active therapy, CEA can be used in conjunction with  the patient’s health history, a physical examination, and a diagnostic imaging tests.
    • Data is insufficient to recommend the use of CEA for monitoring response to treatment. However, in the absence of readily measurable disease, an increasing CEA may be used to indicate treatment failure.
  •  p53 as a marker for breast cancer:
    • Data is insufficient to recommend the use of p53 measurements for management of patients with breast cancer.

ASCO 2006 Update of Recommendations for the Use of Tumor Markers for Gastrointestinal Cancers (Colorectal cancer and Pancreatic Cancer)

 

Tumor Marker Recommendations for Colorectal Cancer

 

Tumor Marker

Screening

Staging/Treatment Planning

Testing for the Spread of Cancer After Surgery

Finding out how the Treatment is Working

CEA

No

Only to assist in treatment planning or staging; not making decisions about adjuvant therapy

Yes, every three months for at least three years after diagnosis, for patients with stage II or III cancer

Yes, every one to three months during treatment, for patients with metastatic cancer

CA 19-9

No

No

No

No

DNA ploidy

Not Applicable

No

Not Applicable

Not Applicable

p53

No

No

No

No

ras oncogene

No

No

No

No

TS, DPD, TP

No

No

No

No

MSI

Not Applicable

No

Not Applicable

No

18q-LOH/DCC

Not Applicable

No

Not Applicable

No

 

Tumor Marker Recommendations for Pancreatic Cancer

 

Tumor Marker

Screening

Staging/Treatment Planning

Finding out if the Cancer Has Come Back

Finding out how the Treatment is Working

CA 19-9

No

No

No, need to confirm with additional tests, such as biopsy or imaging tests

Yes, every one to three months during treatment, for patients with metastatic cancer

 

National Comprehensive Cancer Network (NCCN)
 

Breast Cancer Version 3.2014
Invasive Breast Cancer

 

Principles of Monitoring Metastatic Disease

 

Suggested Intervals for Follow-Up for Patients with Metastatic Disease
Serum Tumor Markers (CEA, CA 15-3, CA 27.29) 

  • Baseline prior to new therapy: Optional
  • Chemotherapy: Optional
  • Endocrine Therapy: Optional
  • Restaging if concern for progression of disease: Optional

Findings concerning for progression of disease include:

  • Increasing serum tumor markers for CEA, CA 15-3, CA 27.29 

Colon Cancer Version 1.2015

 

Pathologic Stage

  • T3, N0, M0 (no high risk features) or T3, N0, M0 at high risk for systemic recurrence or T4, N0, M0 Surveillance: CEA every 3-6 months for 2 years, then every 6 months for a total of 5 years, if patient is a potential candidate for further intervention.  
  •  T1-3, N1-2, M0 or T4, N1-2, M0 Surveillance: CEA every 3-6 months for 2 years, then every 6 months for a total of 5 years, if patient is a potential candidate for further intervention.

Note: CEA monitoring is not recommended beyond 5 years.

 

Suspected or proven metastatic proven metastatic synchronous adenocarcinoma (Any T, any N, M1) Work Up includes: CEA 
 
Resectable Synchronous Liver and/or Lung Metastases only Surveillance: CEA every 3-6 months for 2 years, then every 6 months for 3-5 years. 

 

Unresectable Synchronous Liver and/or Lung Metastases only Surveillance: CEA every 3-6 months x 2 years, then every 6 months for 3-5 years.

 

Note: CEA monitoring is not recommended beyond 5 years.

 

Recurrence

  • Work up includes serial CEA elevation


Rectal Cancer Version 1.2015
Rectal cancer appropriate for resection

  • Work up includes CEA

Surveillance

  • CEA every 3-6 months for 2 years, then every 6 months for total of 5 years for T2 or greater lesions, if patient is a potential candidate for resection of isolated metastasis.   

Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer

 

Clinical Presentation: Suspicious/palpable pelvic mass detected on abdominal/pelvic exam and or ascites abdominal distention, and/or
 
Symptoms such as bloating, pelvic or abdominal pain, difficulty eating or feeling full quickly, or urinary symptoms (urgency or frequency) without other obvious source of malignancy:

  • Work up includes: CA-125 
     

Diagnosis by previous surgery or tissue biopsy (cytopathology)

  • Work up includes: CA 125


Stage 1, II, III and IV Complete Response
Monitoring or Follow Up
: CA-125 every visit if initially elevated. 

 

Less Common Ovarian Histopathologies (malignant germ cell neoplasms, carcinosarcoma (MMMT), and malignant sex cord stromal tumors)

 

Pelvic Mass
Workup: CA-125

 

Serum Tumor Marker Surveillance for Germ Cell and Sex Cord Stromal Tumors (CA-125)

 

Germ Cell Tumors

  • <1 Year: Every 2-4 months
  • Years 1-2: Every 2-4 months
  • Years: 2-3: Not indicated
  • Years 3-5: Not indicated
  • >5 Years: Not indicated

Sex Cord Stromal Tumors 

  • <1 Year: Every 2-4 months
  • Years 1-2: Every 2-4 months
  • Years 2-3: Every 6 months
  • Years 3-5: Every 6 months
  • >5 Years: Every 6 months  

Note: SGO (Society of Gynecologic Oncology) recent recommendations state that the use for surveillance of CA-125 is optional. NCCN panel concurs with SGO opinion.


Pancreatic Adenocarcinoma Version 2.2014

 

Discussion: Panel recommends measurement of serum CA19-9 levels:

  •  Prior to surgery
  •  Following surgery immediately prior to administration of adjuvant therapy, and
  • Surveillance – every 3-6 months for 2 years, then annually 

Endometrial Cancer Version 2.2015 
Suspected Extrauterine Disease (endometrioid histology)
Workup: CA-125 (optional)
Surveillance: CA-125 (optional)

 

Intrahepatic Cholangiocarcinoma

  • Workup: Consider CEA and CA 19-9

Extrahepatic Cholangiocarcinoma

  •  Workup: Consider CEA and CA 19-9

 

Gallbladder Cancer

  • Workup: Consider CEA and CA 19-9


Occult Primary Version 1.2015
Adenocarcinoma or Carcinoma not otherwise specified

  • Chest (multiple nodules) or Pleural Effusion
    • Women additional work up: CA-125
  • Peritoneal/Ascites
    • Women additional work up: CA-125
    • Men and Women additional work up: CA 19-9 level if pancreatic or biliary tract primary suspected
  •  Retroperitoneal Mass
    • Women additional work up: CA-125
  • Inguinal Nodes
    • Women additional work : CA-125
  • Liver
    • Men and Women additional work up: CA 19-9 level if pancreatic or biliary tract primary suspected

 
Thyroid Carcinoma Version 2.2014

 

Medullary Carcinoma
Clinical Presentation: Medullary Thyroid Carcinoma on FNA

  • Diagnostic Procedures:  CEA

Clinical Presentation: Medullary Thyroid Carcinoma Diagnosed After Initial Thyroid Surgery

  • Additional work up:  CEA

 Clinical Presentation: Germline Mutation of RET proto-oncogene

  • MEN2B or MEN2A/Familial Medullary Thyroid Carcinoma
    • CEA

Management 2-3 months postoperative:

  • CEA

Detectable basal calcitonin or elevated CEA

  • Surveillance
    • CEA every 6-12 months

Basal calcitonin undetectable or CEA within reference range

  •  Surveillance
    • Annual CEA


For the 2013 update, the NCCN panel added recommendations to consider molecular diagnostics for evaluating FNA results that are suspicious for:

  1. Follicular or Hurthle cell neoplasms; or
  2. Follicular lesion of undetermined significance

For the 2014 update, the NCCN Panel recommends (category 2B) molecular diagnostic testing for evaluating FNA results that are suspicious for:

  1. Follicular or Hurthle cell neoplasms; or
  2. AUS/Follicular lesion of undetermined significance

For the 2014 update, the NCCN Panel revised the recommendation for molecular diagnostic testing to category 2B for indeterminate FNA results based on a series of panel votes. The Panel noted that molecular testing (both the Gene Expression Classifier and individual mutational analysis) was available in the majority of NCCN Member Institutions. 


The American College of Obstetricians and Gynecologists (ACOG)
Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer

  • Epithelial ovarian cancer is most commonly detected in advanced stage, when the overall 5 year survival rate is 20-30%.
  •  Detection of early stage ovarian cancer results in improved survival.
  • There is currently no effective strategy for ovarian cancer screening.
  • The obstetrician-gynecologist should be aware that there may be symptoms (including increased abdominal size or bloating, abdominal or pelvic pain, or feeling full quickly or difficulty eating) associated with ovarian cancer that should be investigated.
  • Evaluation of the symptomatic patient includes physical examination and may include transvaginal ultrasonography and measurement of levels of the serum tumor marker CA-125.
  • When a patient with a suspicious or persistent complex adnexal mass requires surgical evaluation, a physician trained to appropriately stage and debulk ovarian cancer, such as a gynecologist oncologist, should perform the operation.

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Prior Approval: 

 

Not applicable


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Policy: 

The following serum tumor markers are considered medically necessary for the diagnosis and management/monitoring of the specific condition(s) noted:

 

Note: See information above regarding when tumor markers should be performed 

 

Tumor Marker Condition(s)

Carcinoembryonic Antigen (CEA)_(82378)

  • Metastatic Breast Cancer
  • Colorectal Cancer
  • Hepatobilliary Cancers including:
    • Intrahepatic Cholangiocarcionoma
    • Extrahepatic Cholangiocarcinoma
    • Gallbladder Cancer
  • Medullary Thyroid Carcinoma 
Cancer Antigen 125 (CA-125)
(86304)
  • Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
  • Undiagnosed pelvic mass: Less Common Ovarian Histopathologies (malignant germ cell neoplasms; carcinosarcoma (MMMT); malignant sex cord stromal tumors
  • Endometrial Cancer: suspected extrauterine disease (endometrioid histologies)
  • Occult Primary - Adenocarcinoma or Carcinoma not otherwise specified
    • Chest (multiple nodules) or pleural effusion
    • Peritoneal/Ascites
    • Retroperitoneal mass
    • Inguinal nodes (women)
CA 19-9
(86301)
  • Pancreatic Cancer
  • Hepatobilliary Cancers including:
    • Intrahepatic Cholangiocarcionoma
    • Extrahepatic Cholangiocarcinoma
    • Gallbladder Cancer
  • To aid in the detection of cholangiocarcinoma in patients with primary sclerosing cholangitis
  • Occult Primary – Adenocarcinoma or Carcinoma not otherwise specified
    • Peritoneal/Ascites – if pancreatic or biliary tract primary suspected
    • Liver – if pancreatic or biliary tract primary suspected

CA 15-3 and CA 27.29
(86300)

  •  Metastatic Breast Cancer

Gene expression classifier for thyroid nodule (i.e., Afirma® Thyroid FNA Analysis)

For assessing fine needle aspiration samples from thyroid nodules that are indeterminate

 

All other applications of serum tumor markers are considering investigational including but not limited to the following as the peer reviewed medical literature does not support these tests having sufficient sensitivity or specificity to define their clinical role:

  • Ova-1 (CA-125, apolipoprotein A1, beta 2 microglobulin transferin and pre-albumin) and ROMA (CA-125 and HE4). See Medical Policy Proteomics Based Testing for Evaluation of Ovarian Cancer
  • Human epididymis protein (HE4)
  • A2-PAG (pregnancy associated alpha2 glycoprotein)
  • BCM (breast cancer mucin)
  • CAM 17-1 (antimucin monoclonal antibody)
  • CAM-26 (carcinoma associated mucin antigen)
  • CAM-29 (carcinoma associated mucin antigen)
  • MCA (mucinous carcinoma associated antigen)
  • TPA (tissue polypeptide antigen)
  • TPS (tissue polypeptide specific antigen)
  • CA 72-4 (cancer antigen 72-4)
  • CA-50 (cancer antigen 50)
  • CA-242 (cancer antigen 242)
  • CA-195 (cancer antigen 195)
  • CA-549 (cancer antigen 549)
  • CA-SCC (squamous cell carcinoma antigen)
  • CAR-3 (antigenic determinant recognized by monoclonal antibody AR-3)
  • DMSA (pentavalent technetium-99mm dimercaptosuccinic acid) (remove?)
  • NSE (neuron specific enolase)
  • Du-PAN-2 (sialylated carbohydrate antigen)
  • EPCA-2 (early prostate cancer antigen)
  • TAG-12 (tumor associated glycoprotein 12)
  • TAG 72 (tumor associated glycoprotein 72)
  • TAG-72-3 (tumor associated glycoprotein 72-3)
  • TNF-alpha (TNF-a) (tumor necrosis factor alpha)
  • TATI (tumor associated trypsin inhibitor)
  • P-LAP (placental alkaline phosphatase)
  • PNA-ELLA (peanut lectin bonding assay)
  • P53 (monocolonal antibody)
  • SLEX (sialylated Lewis-X antigen)
  • SLX (sialylated SSEA-1 antigen)
  • SPAN-1 (sialylated carbonated antigen SPAN-1) 




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Procedure Codes and Billing Guidelines: 

  • To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
  • The following CPT codes may be used to report serum tumor marker testing:
    • 86300 Immunoassay for tumor antigen, quantitative; CA 15-3 (27.29)
    • 86301 Immunoassay for tumor antigen, quantitative; CA 19-9
    • 86304 Immunoassay for tumor antigen, quantitative; CA 125
    • 86305 Human epididymis protein
    • 86316 Immunoassay for tumor antigen; other antigen, quantitative (eg. CA 50, 72-4, 549, CgA), each
    • 82378 Carcinoembryonic antigen (CEA)
    • 84999 Unlisted chemistry procedure  

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Selected References: 

  • Burtis C.A., Ashwood E.R., editors. Tietz textbook of clinical chemistry. Third edition. Philadelphia: W.B. Saunders, c1999. Pages 735-740.
  • Gion M., Boracchi P., Dittadi R., Biganzoli E., Peloso L., Mione R., Gatti C., Paccagnella A., Marubini E. Prognostic role of serum CA 15.3 in 362 node-negative breast cancers. An old player for a new game. European Journal of Cancer; June 2002; 38 (9): 1165-6.
  • Jacobs IJ, et al..  Screening for ovarian cancer: a pilot randomised controlled trial.  Lancet  1999 Apr 10;353(9160):1207-10.
  • Jacobs IJ, et al.  Risk of diagnosis of ovarian cancer after raised serum CA 125 concentration: a prospective cohort study.  BMJ  1996 Nov 30;313(7069):1355-8.
  • ACOG Committee Opinion: number 280, December 2002. The role of the generalist obstetrician-gynecologist in the early detection of ovarian cancer.  Obstet Gynecol  2002 Dec;100(6):1413-6.
  • Tuxen MK, Soletormos G, Dombernowsky P. Serum tumor marker CA 125 for monitoring ovarian cancer during follow-up.  Scand J Clin Lab Invest  2002;62(3):177-88.
  • Smith RA, Cokkinides V, Eyre HJ et al. American Cancer Society Guidelines for the early detection of cancer, 2003. CA Cancer J Clin 2003 Jan-Feb;53(1):27-43.
  • Bast RC, Ravdin P, Hayes D et al. 2000 update of recommendations for the use of tumor markers on breast and colorectal cancer:  clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol 2001; 19(6):1865-78.
  • Micke O, Bruns F, Kurowski R et al. Predictive value of carbohydrate antigen 19-9 in pancreatic cancer treated with radiotherapy.  Int J Radiat Oncol Biol Phys 2003; 57(1):90-7.
  • Kurebayashi J, Yamaoto Y, Tanaka K et al.  Significance of serum carcinoembryonic antigen and CA 15.3 in monitoring advanced breast cancer patients treated with systemic therapy: a large-scale retrospective study.  Breast Cancer 2003; 10(1):38-44.
  • 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.
  • Zatelli MC, Torta M, Leon A et al. Chromogranin A as a marker of neuroendocrine neoplasia: an Italian Multicenter Study. Endocr Relat Cancer. 2007 Jun;14(2):473-82.
  • Seregni E, Ferrari L, Bajetta E et al. Clinical significance of blood chromogranin A measurement in neuroendocrine tumours. Ann Oncol. 2001;12 Suppl 2:S69-72.
  • Stirling D, Evans DGR, Pichert G et al. Screening for Familial Ovarian Cancer: Failure of Current Protocols to Detect Ovarian Cancer at an Early Stage According to the International Federation of Gynecology and Obstetrics System. J Clin Oncol 2005; 23(24):5588-5596.
  • Bast Jr. RC. Status of Tumor Markers in Ovarian Cancer Screening. J Clin Oncol 2003; 21(10s):200s-205s.
  • Karlan BY, McIntosh M. The Quest for Ovarian Cancer's Holy Grail: Can CA-125 Still Be the Chalice of Early Detection? J Clin Oncol 2007;25(11): 1303-1304.
  • Marcos CA, Martinez DA, de Los Toyos JR et al. The usefulness of new serum tumor markers in head and neck squamous cell carcinoma. Otolaryngol Head Neck Surg. 2009 Mar; 140(3):375-80.
  • Tsai HL, Chang YT, Chu KS et al. Carcinoembryonic antigen in monitoring of response to cetuximab plus FOLFIRI or FOLFOX-4 in patients with metastatic colorectal cancer. Int J Biol Markers. 2008 Oct-Dec; 23(4):244-8.
  • Li YG, Zhang N. Clinical significance of serum tumor M2-PK and CA 19-9 detection in the diagnosis of cholangiocarcinoma. Dig Liver Dis. 2009 Jan 23. [Epub ahead of print]
  • Andriole GL, Crawford ED, Grubb 3rd RL et al. Mortality Results from a Randomized Prostate-Cancer Screening Trial. N Engl J Med 2009; 360(13): 1310-19.
  • Brawley OW, Ankerst DP, Thompson IM. Screening for Prostate Cancer. CA Cancer J Clin 2009[Epub prior to print June 29, 2009].
  • Lin K, Lipsitz R, Miller T et al. Benefits and Harms of Prostate-specific Antigen Screening for Prostate Cancer: An Evidence Update for the U.S. Preventive Services Task Force. Ann Intern Med. 2008;149(3):192-99.
  • Lim LS, Sherin K, and the American College of Preventive Medicine (ACPM) Prevention Practice Committee. Screening for Prostate Cancer in U.S. Men: ACPM Position Statement on Preventive Practice. Am J Prev Med 2008;34(2):164-70.
  • Charatcharoenwitthaya P, Enders FB, Halling KC et al. Utility of Serum Tumor Markers, Imaging, and Biliary Cytology for Detecting Cholangiocarcinoma in Primary Sclerosing Cholangitis. Hepatology 2008;48:1106-1117.
  • Juntermanns B, radunz S, Heuer M et al. Tumor markers as a diagnostic key for hilar cholangiocarcinoma. Eur J Med Res. 2010 Aug 20; 15(8):357-61.
  • Morris-Stiff G, Teli M, Jardine N et al. CA19-9 antigen levels can distinguish between benign and malignant pancreatobiliary disease. Hepatobiliary Pancreat Dis Int. 2009 Dec; 8(6):620-6.
  • Abbas G, Lindor KD. Cholangiocarcinoma in primary sclerosing cholangitis. J Gastrointest Cancer. 2009; 40(1-2):19-25. Epub 2009 Aug 25.
  • Gilligan TD, Seidenfeld J, Basch EM et al. American Society of Clinical Oncology Practice Guideline on Uses of Serum Tumor Markers in Adult Males with Germ Cell tumors. J Clin Oncol 2010; 28(20):3388-3404.
  • Moore RG, McKeekin DS, Brown AK et al. A novel multiple marker bioassay utilizing HE4 and CA-125 for the prediction of ovarian cancer in patients with pelvic mass. Gynecol Oncol 2009; 112(1):40-6.
  • Nolen B, Velikokhatnaya L, Marrangoni A et al. Serum biomarker panels for the discrimination of benign from malignant cases in patients with an adnexal mass. Gynecol Oncol 2010; 117(3);440-5.
  • Andersen MR, Goff BA, Lowe KA et al. Use of a symptom index, CA 125 and HE4 to predict ovarian cancer. Gynecol Oncol 2010; 116(3):378-83.
  • Molina R, Escudero JM, Auge JM et al. HE4 a novel tumour marker for ovarian cancer: comparison with CA 125 and ROMA algorithm in patients with gynaecological diseases. Tumor Biol 2011; 32:1087-95. doi: 10.007/s13277-011-0204-3.
  • Moore RG, Miller MC, Disilvestro P et al. Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass. Obstet Gynecol. 2011 Aug; 118(2 Pt 1): 280-8.
  • Sturgeon CM, Duffy MJ, Hoffmann BR et al. National Academy of Clinical Biochemistry Laboratory Medicine Clinical Practice Guidelines for use of tumor markers in liver, bladder, cervical, and gastric cancers. Clin Chem 2010 Jun;56(6): e1-48. Epub 2010 Mar 5.
  • Anderson GL, McIntosh M, Wu L et al. Assessing lead tome of selected ovarian cancer biomarkers: a nested case-control study. J Natl Cancer Inst 2010; 102(1):26-38.
  • Lenhard M, Steiber P, Hertlein L et al. The diagnostic accuracy of two human epididymis protein 4 (HE4) testing systems in combination with CA125 in the differential diagnosis of ovarian masses. Clin Chem Lab Med. 2011 Sep 16 [Epub ahead of print].
  • Holcomb K, Vucetic Z, Miller MC et al. Human epididymis protein 4 offers superior specificity in the differentiation of benign and malignant adnexal masses in premenopausal women. Am J Obstet Gynecol. 2011 Oct;205(4):358.el-6. Epub 2011 May 14. 
  • American Association for the Study of Liver Disease (AASLD). ASSLD Practice Guideline. Management of Hepatocellular Carcinoma: An Update. July 2010
  • American Association for the Study of Liver Disase (AASLD). ASSLD Practice Guideline. Diagnosis and Management of Primary Sclerosing Cholangitis. February 2010.
  • The American College of Obstetrician and Gynecologists (ACOG). Committee Opinion, Number 477, March 2011. The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer.
  • American Society of Clinical Oncology (ASCO). Guideline for Tumor Markers for Testicular Cancer and Extragonadal Germ Cell Tumors in Teenage Boys and Men.
  • American Society of Clinical Oncology (ASCO). Guideline for Tumor Markers for Breast Cancer.
  • American Society of Clinical Oncology (ASCO). Guidekube for Tumor Markers for Gastrointestinal Cancers
  • National Comprehensive Cancer Network (NCCN): Version 2.2013 Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Periotoneal Cancer; Less Common Ovarian Histopathologies: Version 1.2014 Colon Cancer: Version 2.2013 Carcinoid Tumors and Neuroendocrine Tumors: Version 1.2013 Testicular Cancer (nonseminoma and pure seminoma): Version 2.2013 Hepatobiliary Cancers: Version 2.2014 Small Cell Lung Cancer: Version 1.2013 Pancreatic Adenocarcinoma: Version 4.2013 Prostate Cancer: Version 2.2013 Gastric Cancer: Version 3.2013 Breast Cancer: Version 2.2013 Thyroid Carcinoma-Medullary Carcinoma.
  • National Comprehensive Cancer Network (NCCN) Version 1.2013 Endometrial Carcinoma.
  • National Comprehensive Cancer Network (NCCN) Version 2.2013 Thyroid Carcinoma.
  • American Thyroid Association. Molecular Analysis for Mutations in Thyroid FNA Improves the Diagnosis of Malignancy for All Categories of Indeterminate Cytology. J Clin Endocrinol Metab 2011;96:3390-7, Epub August 31, 2011.
  • AACE ( American College of Endocrinology)/AAES (American Association of Endocrine Surgeons) Medical/Surgical Guidelines for Clinical Practice: Management of Thyroid Carcinoma. Endocrine Practice Vol.7 No. 3 May/June 2001. 
  • UpToDate. Diagnostic Apprache to and Treatment of Thyroid Nodules. Douglas S. Ross, M.D.. This Topic Last Updated February 13, 2014.
  • MedScape. Molecular Diagnosis for Indeterminate Thyroid Nodules on Fine Needle Aspiration. 2013. www.medscape.com
  • Erik K. Alexander, M.D. et al. The New England Journal of Medicine, Preoperative Diagnosis of Benign Thyroid Nodules with Indeterminate Cytology. August 23, 2012. N Engl J Med 367;8.
  • Veracyte. Afirma Thyroid FNA Analysis.
  • American Society of Clinical Oncology (ASCO) 2010 Clinical Practice Guideline on the Uses of Serum Tumor Markers in Adult Males with Germ Cell Tumors. JCO July 10, 2010 vol.28 no.20 3388-3404. Also available at http://jco.ascopubs.org
  • National Comprehensive Cancer Network (NCCN):  Version 2.2014 Thyroid Carcinoma; Version 3.2014 Breast Cancer; Version 1.2015 Colon Cancer; Version 1.2015 Rectal Cancer; Version 2.2014 Hepatobiliary Cancers;  Version 3.2014 Ovarian Cancer; Version 2.2014 Pancreatic Adenocarcinoma; Version 1.2015 Uterine Neoplasm.; Version 1.2015 Occult Primary. Also available at www.nccn.org

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Policy History: 

 

Date                                        Reason                               Action

December 2010                      Annual review                     Policy revised

December 2011                      Annual review                     Policy renewed

December 2012                      Annual review                     Policy renewed

October 2013                         Annual review                     Policy revised

November 2013                      Interim review                     Policy revised

March 2014                           Interim review                      Policy revised

October 2014                         Annual review                     Policy revised

 


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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 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.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.

 
Contact Information
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
  P.O. Box 9232
  Des Moines, IA 50306-9232
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