Appeal type: Experimental/Investigational
Decision: Overturned

This is a young male patient with a history of blood in the stool, abdominal pain, and nausea and vomiting.  A work up was performed to rule out irritable bowel disease including biomarkers of inflammation such as calprotectin and lactoferrin of the stool; which were normal.  It was reported that the patient's symptoms subsequently resolved. 

Stool biomarkers are relatively sensitive and specific tests to determine possible causes of rectal bleeding including polyps and IBD in a non-invasive fashion.  The tests have been validated.  Therefore, the scientific evidence in peer-reviewed literature does support a result of improvement in health outcome.

Per Smalley W. et al. (2019), "Calprotectin and fecal lactoferrin have been proposed as markers for inflammatory conditions, such as IBD.  There are several studies using fecal calprotectin with different threshold values to identify persons with IBD.  Based on a review of the available data, it appears that using fecal calprotectin with a threshold of 50 mg/g yields the optimal performance.  These practice guideline recommendations for the evaluation of functional diarrhea and diarrhea-predominant irritable bowel syndrome [IBS-D] with the intent of excluding other diagnoses in adults were developed using the Grading of Recommendations Assessment, Development, and Evaluation [GRADE] framework and in adherence with the standards for guideline development set forth by the Institute of Medicine for the creation of trustworthy guidelines.  These guidelines are intended to reduce practice variation and promote high-quality and high-value care for this patient population.  Current evidence supports the use of fecal calprotectin or fecal lactoferrin and stool testing for Giardia in patients presenting with chronic diarrhea."

Per Menees, S. B. et al. (2015), "Systematic review identified 1,252 citations.  After cross-referencing medical subject headings, detailed evaluation identified 140 potentially relevant journal articles/abstracts for C-reactive protein [CRP], erythrocyte sedimentation rate [ESR], calprotectin, and lactoferrin of which 4, 4, 8, and 2 fulfilled our inclusion criteria, respectively.  None of the biomarkers reliably distinguished between IBS and healthy controls.  At a CRP level of 0.5 or calprotectin level of 40 g/g, there was a 1% probability of having IBD.  Individual analysis of ESR and lactoferrin had little clinical utility.  Conclusion: CRP and calprotectin of 0.5 or 40, respectively, essentially excludes IBD in patients with Irritable Bowel Syndrome [IBS] symptoms.  The addition of CRP and calprotectin to symptom-based criteria may improve the confident diagnosis of IBS."

The diagnosis of IBD or other causes of rectal bleeding is based on a synthesis of a number of tests well as an appropriate physical exam and history.  The other tests include laboratory assessment, radiologic and endoscopic procedures.  Stool calprotectin and lactoferrin biomarkers of inflammation are appropriately sensitive and specific and non-invasive.  Based on societal recommendations including American College of Gastroenterology (AGA) and North American Society for Pediatric Gastroenterology, Hepatology & Nutrition (NASPGHAN) these tests would be considered in the realm of standard of care at this time.  Therefore, the Fecal Calprotectin to screen for IBD at Quest Diagnostics is the best available treatment for this patient at this time. 

The carrier's denial of coverage for Fecal Calprotectin to screen for IBD should be reversed.