Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Crohn's disease
Treatment: Fecal calprotectin

The health plan should not cover the fecal calprotectin.

The provision of this service would not be more beneficial than any standard treatments and assays.

The substance calprotectin is a calcium-binding protein that is excreted in the stool of patients with IBD and other gastrointestinal conditions. Fecal calprotectin, which used as a marker of intestinal inflammation, has been suggested to be used as an aide in the diagnosis and as a predictor of relapse in inflammatory bowel disease (IBD) including Crohn's disease and ulcerative colitis. The use of fecal calprotectin has also been proposed as a predictive response to treatment in patients with IBD rather than relying solely on clinical symptoms. Although fecal calprotectin has been most frequently studied in IBD, several investigators have measured fecal calprotectin levels in other intestinal diseases such as colorectal cancer, diverticular disease, and colonic polyposis.

Mao and colleagues undertook a meta-analysis to evaluate the predictive ability of fecal calprotectin in patients with the diagnosis of inflammatory bowel disease (IBD). The authors analyzed six prospective studies with a total of 672 IBD patients (318 patients with ulcerative colitis (UC) and 354 patients with Crohn's disease (CD)). The pooled sensitivity and specificity of fecal calprotectin to predict relapse of IBD was 78% and 73%, respectively. The capacity of fecal calprotectin to predict relapse was comparable between UC and CD. [1] The authors concluded that although fecal calprotectin evaluation is a simple, non-invasive test, the diagnostic performance of this test was lower than expected. The authors noted that a limitation of the studies was that remission was based on subjective clinical activity indices. Additional prospective studies using endoscopy to confirm relapse are needed to clarify the role of fecal calprotectin.
...
Thus, the fecal calprotectin testing is considered experimental / investigational as it is shown by reliable evidence that the consensus of opinion among experts regarding the treatment, procedure, device, or drug is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficiency as compared with the standard means of treatment or diagnosis.  This standard is accepted by the GI community as well as other related societies for determining whether treatment is E/I. 

Sharbatdaran et. al. note "the results showed that fecal calprotectin could be a noninvasive marker to differentiate IBD from IBS. Considering the cutoff point of calprotectin with 73% sensitivity and 89% specificity, it could be used as a diagnostic method to differentiate the inflammatory bowel diseases." [11] This is by no means definitive and the sensitivity and specificity are not as effective as currently available methodologies.

The provision of a fecal calprotectin test has not been shown to have a positive effect on healthcare outcomes more than standard approaches to monitoring and managing patients who have inflammatory bowel disease. As such, the provision of this service would not be more beneficial than any standard treatments and assays.