Compliance with the provisions in this policy may be monitored and addressed
through post payment data analysis and subsequent medical review audits.  
  

**History/Background and/or General Information  
  
** This LCD pertains to Wireless Capsule Endoscopy (WCE) diagnostic modality
in the gastrointestinal tract.  
  
**Covered Indications**

  1. WCE is indicated for the diagnosis of occult gastrointestinal bleeding (i.e., likely involving the small intestine), the site of which has not previously been identified by any of the following: upper gastrointestinal endoscopy, colonoscopy, push enteroscopy, nuclear imaging or radiological procedures.
  2. WCE is limited to those patients who have undergone upper GI endoscopy **and** colonoscopy and these tests have failed to reveal a source of bleeding. Medicare would not expect to see a WCE provided if upper and lower endoscopy has not previously been performed. Documentation in the medical record must indicate that the beneficiary has suspected GI blood loss with or without anemia. Appropriate differential diagnoses for the evaluation of such bleeding include:
    * Angiodysplasia
    * Neoplasm
    * Iron deficiency anemia, which is unexplained after upper and lower endoscopy
    * Zollinger-Ellison syndrome
    * Tuberculosis
    * Vasculitis
    * Radiation enteritis
    * Meckels diverticulum
    * Jejunal diverticula
    * Chronic mesenteric ischemia
  3. Other indications include the management of celiac disease (e.g., surveillance for small-intestinal cancer) and of Crohn's disease (that is, either Crohn's disease is suspected, but not diagnosed, or colonic involvement of Crohn's disease is known, but it is necessary to determine whether there is also involvement of the small bowel). In addition, WCE is indicated where an indeterminate type of colitis exists, but where a more specific diagnosis is being sought via small bowel evaluation.
  4. Esophageal capsule endoscopy may be used in the evaluation of esophageal varices in patients with portal hypertension, as an alternative to upper GI endoscopy.

**Limitations**  
  
In addition to any specific indications noted above, WCE is limited as
follows:

  1. Erosive esophagitis and Barrett's esophagus may be viable clinical indications in the future, but further peer-reviewed literature is being sought before this additional coverage might become available.
  2. This test is not reimbursable for colorectal cancer screening.
  3. The test is payable only for services using FDA-approved devices.
  4. This test is not reimbursable for the confirmation of lesions or pathology normally within the reach of upper or lower endoscopes (lesions proximal to the ligament of Treitz or distal to the ileum).
  5. This test is only covered when performed by physicians trained in endoscopy or for independent diagnostic testing facilities, which are under the general supervision of a physician trained in endoscopy procedures.
  6. Contraindications include: pregnancy, cardiac pacemaker and other implanted electro-medical devices, swallowing disorders, known or suspected GI obstruction, strictures or fistulas based on the clinical picture or preprocedure testing.
  7. Medicare would not expect to see a second capsule administered per episode of illness unless it was to guarantee an adequate examination (e.g., the initial capsule does not penetrate the pylorus). Please note that any other procedure codes that are used to ensure proper passage of the capsule must be reasonable and necessary and documented appropriately.
  8. Medicare expects repeat wireless capsule endoscopic studies for any patient to be for medically reasonable and necessary clinical circumstances consistent with accepted standards of medical practice and that the medical records demonstrate such.

**  
Notice:** Services performed for any given diagnosis must meet all of the
indications and limitations stated in this policy, the general requirements
for medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.  
  
The redetermination process may be utilized for consideration of services
performed outside of the reasonable and necessary requirements in this LCD.