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Medical Policy: 02.01.34
Original Effective Date: June 2008
Reviewed: October 2011
Revised:
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:
Inflammatory bowel disease (IBD) can be subdivided into ulcerative colitis (UC) and Crohn’s disease (CD), both of which present with symptoms of diarrhea and abdominal pain. The definitive diagnosis can usually be established by a combination of radiographic, endoscopic, and histologic criteria, although in 10%–15% the distinction between ulcerative colitis and Crohn’s disease cannot be made with certainty. Several serum antibodies including anti-neutrophilic cytoplasmic antibodies (ANCA),perinuclear antineutrophil cytoplasmic antibodies (pANCA), anti-Saccharomyces cerevisiae (ASCA), Escherichia coli antibodies (Anti-OmpC), Pseudomonas fluorescens (Anti-I2), and Clostridium species antibodies (Anti-CBir1) have been associated with IBD. Testing for ANCA is currently available in most clinical laboratories. ASCA is a more recent assay that is becoming more widely available, but the reliability of testing for ASCA among different laboratories may be more variable as compared to ANCA.
These serum antibodies have several potential uses. They can be used as diagnostic tests to improve the efficiency and accuracy of diagnosing IBD to decrease the extent of the diagnostic workup or to avoid invasive tests. As a diagnostic test, they might also be useful in differentiating between UC and CD in cases of indeterminate colitis. A second potential use is to classify subtypes of IBD by location of disease (i.e., proximal vs. distal bowel involvement) or by disease severity, thereby providing prognostic information. It has also been proposed that these markers may predict response to anti-tumor necrosis factor (TNF) therapy or identify susceptibility to IBD among family members of an affected individual.
The Prometheus® IBD Serology 7 (Prometheus© Inc.) is a commercially available diagnostic system that uses combinations of tests for ANCA, pANCA, ASCA, Anti-CBir1, and Anti-OmpC to aid in the diagnosis of IBD. This system uses a 2-step process to diagnose IBD and to differentiate between UC and CD. Patients who test positive on the initial screen are further analyzed by a set of proprietary markers and enzyme reagents to distinguish between true positive results and artifacts of fixation. In this way, the Prometheus© system is intended to increase the specificity of the test compared to other laboratories. The company also markets a testing strategy for predicting response to anti-TNF therapy and to monitor therapy.
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Prior Approval:
Not applicable
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Policy:
Determination of serologic markers, including but not limited to anti-neutrophil cytoplasmic antibody (ANCA), perinuclear anti-neutrophil cytoplasmic antibody (pANCA), anti-Saccharomyces cerevisiae antibody (ASCA), Escherichia coli antibody (Anti-OmpC), Pseudomonas fluorescens (Anti-I2), and Clostridium species antibody (Anti-CBir1), is considered investigational in the workup and monitoring of patients with inflammatory bowel disease or to differentiate ulcerative colitis from Crohn’s disease.
Systematic reviews have found relatively low sensitivity and moderately high specificity of serologic marker testing for inflammatory bowel disease. In addition, the clinical utility of these assays has not been demonstrated and there is insufficient evidence to evaluate the use of this testing on net health outcomes.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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There is no specific CPT code for detection of ANCA or ASCA. Nonspecific CPT describing immunoassay (83516) and indirect immunofluorescence (88347) may be used.
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Selected References:
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The Medical Policy Reference Manual (MPRM) developed by the Blue Cross Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
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Smith,JC; Lynch, P. Technology Assessment Committee. Serum Antibodies for the Diagnosis of Inflammatory Bowel Disease (IBD): pANAC for Ulcerative Colitis (UC) and ASCA for Crohn’s Disease (CD). Institute for Clinical Systems Improvement (ICSI). Technology Assessment Report #65 Nov 2002.
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Kornbluth A, Sachar, DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative Colitis Practice Guidelines in Adults (Update): American College of Gastroenterology, Practice Parameters Committee. American Journal of Gastroenterology 2004 July;99(7):1371-85.
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IBD Working Group of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. (ESPGHAN) Inflammatory Bowel Disease in Children and Adolescents: Recommendations for Diagnosis--The Porto Criteria. Journal of Pediatric Gastroenterolgy and Nutrition. 2005 Jul;41(1):1-7.
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Reese GE, Constantinides VA, Simillis C et al. Diagnostic precision of anti- Saccharomyces cerevisiae antibodies and perinuclear antineutrophil cytoplasmic antibodies in inflammatory bowel disease. Am J Gastroenterol 2006; 101(10):2410-22.
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North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition; Colitis Foundation of America, Bousvaros A, Antonioli DA, Colletti RB, Dubinsky MC, Glickman JN, Gold BD, et al. Differentiating ulcerative colitis from Crohn disease in children and young adults: report of a working group of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHN) and the Crohn's and Colitis Foundation of America. J Pediatr Gastroenterol Nutr. 2007 May;44(5):653-74.
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Sabery N, Bass D. Use of serologic markers as a screening tool in inflammatory bowel disease compared with elevated erythrocyte sedimentation rate and anemia. Pediatrics. 2007 Jan;119(1):e193-9. Epub 2006 Dec 11.
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Papp M, Norman GL, Altorjay I, Lakatos PL. Utility of serological markers in inflammatory bowel diseases: gadget or magic? World Journal of Gastroenterology. 2007 Apr 14;13(14):2028-36.
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ECRI. Serologic Markers (pANCA, ASCA, and Anti-OmpC) for Diagnosis of Inflammatory Bowel Disease. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 January 15. 8p. (ECRI Hotline Response). Also available: http://www.ecri.org.
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ECRI. Serologic Markers (pANCA, ASCA, and Anti-OmpC) for Diagnosis of Inflammatory Bowel Disease. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 January 15. 8p. (ECRI Hotline Response). Also available: http://www.ecri.org.
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ECRI. Serologic Markers for Diagnosis of Inflammatory Bowel Disease. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2010 November 18. (ECRI Hotline Response). Also available: http://www.ecri.org.
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Kornbluth A, Sachar DB, and The Practice Parameters Committee of the American College of Gastroenterology. Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol 2010;105:501-523.
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Lichtenstein GR, Hanauer SB, Sandborn WJ, and The Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn’s Disease in Adults. Am J Gastroenterol (advance online publication), 2009 January 6.
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Policy History:
Date Reason Action
October 2011 Annual review Policy renewed
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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
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and, therefore, cannot guarantee any results or outcomes.
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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