Serological markers for the diagnosis or management of inflammatory bowel disease are considered experimental/investigational. Tests include, but are not limited to the following:

• Anti-neutrophilic cytoplasmic antibody (ANCA), perinuclear anti-neutrophilic cytoplasmic antibody (pANCA)
• Anti-saccharomyces cerevisiae antibody (ASCA)
• Anti-outer membrane porin C (anti-OmpC) antibody
• Anti-CBir1 flaggellin (anti-CBir1) antibody

Inflammatory bowel disease diagnostic testing combining serologic, genetic, and inflammatory markers (eg, Prometheus IBD Sgi Diagnostic) are considered experimental/investigational.

There is a lack of scientific evidence that the use of these tests is likely to alter the diagnostic workup, the final diagnosis made, or the treatment provided for patients with suspected IBD.  A participating, preferred, or network provider may bill the member for the denied tests.

Description

Inflammatory Bowel Disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract. Ulcerative colitis (UC) and Crohn's disease (CD) are two types of IBD, both of which present with symptoms of diarrhea and abdominal pain. The large intestine (colon) can be inflamed in ulcerative colitis, involving the inner lining of the colon, or by Crohn's disease, which extends the inflammation deeper into the intestine wall. Crohn's disease can also involve the small intestine, or can involve both the small and large intestine.

In approximately 90% of cases, a definitive diagnosis of inflammatory bowel disease can be made by a combination of standard diagnostic modalities (e.g., clinical course, radiographic studies, endoscopy, and interpretation of biopsy material). The histologic description of the biopsied tissue is a crucial factor in establishing the diagnosis. After IBD is diagnosed, it is sometimes difficult to distinguish between UC and CD. This occurs in approximately 10-15% of patients diagnosed with IBD.

Two serum antibody markers, anti-neutrophil cytoplasmic antibody (ANCA) for UC and anti-Saccharomyces cerevisiae antibody (ASCA) for CD have the potential to improve the efficiency and accuracy of diagnosing IBD and to potentially decrease the extent of the diagnostic work-up or to avoid invasive diagnostic imaging. Most clinical laboratories can perform testing for the ANCA marker. However, testing is not as widely available for the ASCA marker. There are no specific CPT codes for the detection of ANCA or ASCA markers.

Prometheus Laboratories Inc., developed a proprietary testing system that uses a combination of tests to aid in the diagnosis of IBD and to differentiate between CD and UC. The new Prometheus IBD sgi Diagnostic is a 4th-generation IBD diagnostic test and the first and only test to combine serologic, genetic, and inflammation markers using its proprietary Smart Diagnostic algorithm to improve the predictive accuracy. This algorithm uses measurements of 17 biologic markers (blood proteins and genes) to determine whether a patient has IBD. Then, if it is determined the patient has IBD, the algorithm examines the marker measurements to differentiate CD from UC. This assay includes 9 serological markers including the proprietary Anti-Fla-X, Anti-A4-Fla2, anti-CBir1, anti-OmpC, and DNAse-sensitive pANCA. Genetic susceptibility is believed to influence immune response and this assay includes evaluation of ATG16L1, STAT3, NKX2-3, and ECM1. Inflammatory markers tested include VEGF, ICAM, VCAM, CRP, SAA.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP.  Medical policy is not an authorization, certification, explanation of benefits or a contract.  Benefits are determined by the Federal Employee Program.

National Blue Cross Blue Shield Association TEC Assessment, Vol. 14, No. 16, 07/1999

National Blue Cross Blue Shield Association Medical Policy 2.04.17, Serum Antibodies for the Diagnosis of Inflammatory Bowel Disease, 02:2008

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