This document addresses the use of wireless capsule endoscopy (WCE or video capsule endoscopy [VCE]) devices which have been developed for imaging portions of the gastrointestinal tract and the patency capsule which is intended to ensure that there are no strictures in the digestive tract to impede passage of the wireless endoscopy capsule.

WCE is accomplished by encasing video, illumination and transmission modules inside a capsule the size of a large vitamin pill. When swallowed, peristalsis moves the capsule along the esophagus and gastrointestinal tract. The encapsulated camera records images and then transmits the data to an external receiver worn by the person being tested. The receiver can download the data to a computer workstation for interpretation.

Magnetically controlled WCE is being explored as a means to visualize the upper gastrointestinal tract (esophagus, stomach, and duodenum). With magnetically controlled WCE, magnets are used to control and maneuver the wireless capsule as it moves through the gastrointestinal tract.

Note: Please see the following related document for additional information:

• MED.00090 Wireless Capsule for the Evaluation of Suspected Gastric and Intestinal Motility Disorders

Clinical Indications

Medically Necessary:

1. Wireless capsule endoscopy of the small bowel is considered medically necessary as a diagnostic imaging tool, in adults or children 2 years of age and older, in the following clinical circumstances:
   1. To investigate obscure gastrointestinal bleeding, suspected to be of small bowel origin, after appropriate evaluation (at a minimum upper and lower endoscopy) has excluded a source of bleeding in the upper gastrointestinal tract or colon; or
   2. For the initial evaluation of individuals with suspected Crohn’s disease when small bowel follow-through (SBFT) or enteroclysis, including CT enteroclysis and upper and lower endoscopy are non-diagnostic AND there is no suspected or confirmed gastrointestinal obstruction, stricture, or fistulae; or
   3. Suspected small intestinal tumors; or
   4. For individuals beginning at age 35 or greater with Lynch syndrome or polyposis syndromes; or
   5. For diagnostic re-evaluation of individuals with known Crohn’s disease who remain symptomatic after appropriate treatment has occurred and there is no suspected or confirmed gastrointestinal obstruction, stricture, or fistulae; or
   6. Refractory undiagnosed malabsorptive syndromes with prior history of negative small bowel biopsy (for example, suspected celiac disease with prior negative biopsy); or
   7. To investigate anemia with concomitant iron deficiency, suspected to be of small bowel origin, after appropriate evaluation (at a minimum upper and lower endoscopy) has excluded a source of anemia from the upper GI tract and colon. 

Not Medically Necessary:

1. Wireless capsule endoscopy is considered not medically necessary for all other indications, including but not limited to:
   1. The evaluation of small bowel disease in individuals with abdominal pain in the absence of gastrointestinal bleeding;
   2. The evaluation of esophageal disease;
   3. Colorectal cancer screening or as a means to identify colon disease;
   4. Individuals with known or suspected gastrointestinal obstruction, stricture, or fistulae.
2. Use of a patency capsule is considered not medically necessary.
3. Use of a magnetically controlled wireless capsule is considered not medically necessary.