Summary Of Evidence

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Analysis of Evidence

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Wireless capsule endoscopic imaging is intended as an adjunctive tool in the detection of certain gastrointestinal (GI) conditions. This procedure requires that a patient ingest a small capsule containing a disposable light source, miniature color video camera, battery, antenna and a data transmitter. The self-contained capsule is made of specially sealed biocompatible material that is resistant to the digestive fluids throughout the GI tract. Following ingestion of the capsule, natural contraction and relaxation of the GI tract propels the camera forward. The camera contained in the capsule records images of the intestinal mucosa as it travels the length of the digestive system. During the entire procedure, which normally takes approximately 8 hours, the patient wears a data recorder around the waist, which captures and stores the images transmitted by the capsule's camera. After completion of the procedure, the patient data recorder is connected to a computer workstation where the images are downloaded, reviewed, and interpreted by the physician. The capsule is designed to be disposable and is excreted naturally from the body.

Indications for wireless capsule endoscopy:

• For investigating suspected small intestinal bleeding in persons with objective evidence of recurrent, obscure GI bleeding (e.g., persistent or recurrent iron-deficiency anemia and/or persistent or recurrent positive fecal occult blood test (FOBT), or visible bleeding) who have had upper and lower GI endoscopies within the past 12 months (esophagogastroduodenoscopy (EGD) and colonoscopy) that have failed to identify a bleeding source;

• For evaluation of regional non-metastatic carcinoid tumors of the small bowel in persons with carcinoid syndrome;

• For evaluation of persons with celiac disease with a positive serology and negative biopsy;

• For re-evaluation of persons with celiac disease who remain symptomatic despite treatment and there is no suspected or confirmed GI obstruction, stricture, or fistulae;

• For initial diagnosis in persons with suspected Crohn's disease (abdominal pain or diarrhea plus 1 or more signs of inflammation (e.g., fever, elevated white blood cell (WBC) count, elevated erythrocyte sedimentation rate, or bleeding) without evidence of disease on conventional diagnostic tests, including small-bowel follow-through or abdominal computed tomography (CT) scan/CT enterography and upper and lower endoscopy (EGD and colonoscopy);

• For re-evaluation of persons with Crohn's disease who remain symptomatic despite treatment and there is no suspected or confirmed GI obstruction, stricture, or fistulae;

• For surveillance of small intestinal tumors in persons with Lynch syndrome, Peutz-Jeghers syndrome and other polyposis syndromes affecting the small bowel; or

• For screening or surveillance of esophageal varices.

Limitations of use:

Wireless capsule endoscopy:

• is NOT indicated for repeat use to verify the effectiveness of surgery.

• is NOT indicated for use as a screening test (other than esophageal varices) and is NOT reimbursable for colorectal cancer screening.

• is NOT indicated for use as an initial test in diagnosing GI bleeding.

• is NOT indicated for use for evaluating intussusception.

• is NOT indicated for use for evaluating the colon, as it is not indicated for the confirmation of lesions of pathology normally within the reach of upper and lower endoscopes (lesions proximal to the ligament of Treitz, or distal to the ileum).

• is NOT indicated for use for evaluating diseases involving the esophagus other than esophageal varices.

• is NOT indicated for use for follow-up of persons with known small bowel disease other than Crohn's disease.

• is NOT indicated for use in confirming pathology identified by other diagnostic means.

• is NOT indicated for use in evaluating the stomach, as it is not indicated for the confirmation of lesions of pathology normally within the reach of upper and lower endoscopes (lesions proximal to the ligament of Treitz, or distal to the ileum).

• is NOT indicated for use in investigating duodenal lymphocytosis, small bowel neoplasm, or suspected irritable bowel syndrome (IBS).

Wireless capsule endoscopy is covered only for services using United States (U.S.) Food and Drug Administration (FDA) approved devices and is not indicated for patients in whom a GI blockage is known or suspected, who have a significantly narrow small bowel, or have a known or suspected abnormal connection between the bowel and/or another organ (e.g., strictures or fistulas). An X-ray exam of the small bowel should be done if there is concern that it may be too narrow for the camera to pass through.

Wireless capsule endoscopy should not be employed in patients with a cardiac pacemaker, or other implanted electromedical devices, or in patients who are pregnant.

In addition to any specific limitations noted above, wireless capsule endoscopy is limited as follows:

• This test is only covered when performed by physicians trained in endoscopy or for independent diagnostic testing facilities (IDTF), which are under the general supervision of a physician trained in endoscopy procedures.

• The capsule should be ingested at least 12 hours after the last meal, and the patient should not be allowed to eat for an additional 3 hours after the capsule is swallowed. Stool in the bowel may cause obstruction of images and result in failure of the study.

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 procedures that are employed to ensure proper passage of the capsule must be reasonable and necessary and documented appropriately.

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.