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.