Serologic Diagnosis of Celiac Disease
DESCRIPTION
Celiac disease, which is also referred to as celiac sprue or gluten-sensitive enteropathy, may be defined as small intestinal inflammation resulting from an immunologic intolerance to gluten (i.e., the proteins derived from wheat, barley, and rye). The diagnosis is confirmed when there is a clinical and histologic improvement on a strict gluten-free diet, and relapse when dietary gluten is reintroduced. The symptoms of celiac disease are nonspecific and are often overlooked. The disease may develop at any time from infancy to adulthood. In children, the disease typically presents between 6 and 24 months, following weaning, and is characterized by abnormal stools, poor appetite, and irritability. In adults, diarrhea is the main presenting symptom, but presenting symptoms may be entirely nonspecific, such as anemia or infertility. Celiac disease is associated with a number of other conditions, including type 1 diabetes mellitus, rheumatoid arthritis, and primary biliary cirrhosis.
Typical or classical celiac disease refers to the presence of malabsorption, while atypical celiac disease consists primarily of extraintestinal manifestations. Silent celiac disease may be entirely asymptomatic and discovered only on biopsy or with serologic testing.
Given the nonspecific nature of the symptoms, definitive diagnoses have been based on the results of small intestinal biopsies showing a flattened intestinal mucosa in association with an inflammatory infiltrate. While a positive biopsy result is considered the gold standard for diagnosis, serologic evaluation of individuals with possible celiac disease can be used to triage a large numbers of individuals with nonspecific symptoms for biopsy. Serologic diagnosis is focused on the detection of IgA antibodies, in the presence of gluten the intestine produces large amounts of antibodies that are secreted intraluminally and spill over into the serum, where they can be detected.
POLICY
Serologic measurement of tissue transglutaminase or antiendomysial antibodies for individuals with signs or symptoms (e.g., diarrhea, abdominal pain, bloating) suggestive of celiac disease is considered medically necessary.
Serologic measurement of antigliadin antibodies for children less than 18 months of age with signs or symptoms (e.g., diarrhea, abdominal pain, bloating) suggestive of celiac disease is considered medically necessary.
HLA-DQ2 and HLA-DQ8 testing to rule out celiac disease for individuals is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
The use of more than one antibody test is considered not medically necessary.
Serologic measurement of deamidated gliadin peptide antibodies for individuals with signs or symptoms (e.g., diarrhea, abdominal pain, bloating) suggestive of celiac disease is considered investigational.
Screening asymptomatic individuals for celiac disease using one or more serologic IgA or IgG measures is considered investigational.
MEDICAL APPROPRIATENESS
HLA-DQ2 and HLA-DQ8 testing to rule out celiac disease for individuals is considered medically appropriate if ANY ONE of the following criteria are met:
The individual has discordant serologic and histologic (biopsy) findings
The individual has persistent symptoms that warrant testing despite negative serology and histology
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is a lack of published evidence-based, randomized controlled trials and well-designed studies to determine whether the use of serologic measurement improves net health outcome.
SOURCES
Barton, S. H., & Murray, J. A. (2008). Celiac disease and autoimmunity in the gut and elsewhere. Gastroenterology Clinics of North America, 37 (2), 411-428.
Basso, D., Guariso, G., Fogar, P., Meneghel, A., Zambon, C. F., Navaglia, F., et al. (2009). Antibodies against synthetic deamidated gliadin peptides for celiac disease diagnosis and follow-up in children. Clinical Chemistry, 55 (1), 150-157.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2011). Serologic diagnosis of celiac disease (5.01.05). Retrieved April 8, 2011 from BlueWeb. (15 articles and/or guidelines reviewed)
Catassi, C., Kryszak, D., Louis-Jacques, O., Duerksen, D., Hill, I., Crowe, S., et al. (2007). Detection of celiac disease in primary care: A multicenter case-finding study in North America. The American Journal of Gastroenterology, 102 (7), 1454-1460. (Level 1 Evidence - Industry sponsored)
Korponay-Szabo, I. R., Szabados, K., Pusztai, J., Uhrin, K., Ludmany, E., Nemes, E., et al. (2007). Population screening for coeliac disease in primary care by district nurses using a rapid antibody test: Diagnostic accuracy and feasibility study. BMJ, 335 (7632), 1244-1247. (Level 1 Evidence - Independent study)
National Guideline Clearinghouse. (2006, December). AGA Institute medical position statement on the diagnosis and management of celiac disease. Retrieved April 16, 2011 from http://www.guidelines.gov.
Rashtak, S., & Murray, J. A. (2009). Celiac disease in the elderly. Gastroenterology Clinics of North America, 38 (3), 433-446.
Sugai, E., Moreno, M. L., Hwang, H. J., Cabanne, A., Crivelli, A., Nachman, F., et al. (2010). Celiac disease serology in patients with different pretest probabilities: Is biopsy avoidable? World Journal of Gastroenterology, 16 (25), 3144-3152.
Tack, G. J., Verbeek, W. H., Schreurs, M. W., & Mulder, C. J. (2010). The spectrum of celiac disease: epidemiology, clinical aspects and treatment. Nature Reviews/Gastroenterology & Hepatology, 7 (4), 204-213.
ORIGINAL EFFECTIVE DATE: 7/11/2011
MOST RECENT REVIEW DATE: 7/11/2011
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