CMS Wireless Capsule Endoscopy Form

Summary Of Evidence

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Analysis of Evidence

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Wireless capsule endoscopy (WCE) requires that the 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 gastrointestinal (GI) tract. Following ingestion of the capsule, natural contraction and relaxation of the GI tract propels the capsule forward. The camera contained in the capsule records images as it travels through the digestive system. During the entire procedure, the patient wears a data recorder around the waist, which captures and stores 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 procedure lasts approximately five minutes for observing the esophageal mucosa and approximately 8 hours when observing intestinal mucosa. The capsule is designed to be disposable and is excreted naturally from the body.

Covered Indications

Wireless capsule endoscopy of the small bowel is considered medically reasonable and necessary when the following conditions have been met: 

• documented continuous blood loss and anemia secondary to obscure bleeding of the small bowel;
• the site of bleeding could not be previously identified by colonoscopy, or endoscopy, or; 
• radiographic exams of the small bowel have failed to reveal a source, or;
• intraoperative enteroscopy is being considered, or;
• initial diagnosis of suspected Crohn’s Disease when there is no evidence provided by conventional diagnostic tests such as small bowel follow-through (SBFT), and upper and lower endoscopy.

Wireless capsule endoscopy of the esophagus is considered medically reasonable and necessary for the following condition, if the criteria have been met:

• Patient diagnosed with portal hypertension who requires immediate evaluation of esophageal varices 
• AND the esophageal capsule endoscopy is performed in lieu of conventional endoscopy because the provider who would perform the endoscopy has determined that the patient’s current medical condition prohibits a conventional endoscopy. 
• AND the medical record clearly reflects why the patient was not a candidate for conventional endoscopy and how the capsule endoscopy would contribute to the patient’s care.

Limitations

• Wireless capsule endoscopy of the esophagus will be considered medically necessary only as specified under “Covered Indications.” Performance of wireless capsule endoscopy for any other reason will be considered not medically necessary.
• Wireless capsule endoscopy is not reimbursable for colorectal cancer screening.
• This test is covered only for services using Food and Drug Administration (FDA) approved devices.
• Wireless capsule endoscopy is not indicated for the confirmation of lesions of pathology normally within the reach of upper and lower endoscopes (proximal to the ligament of Treitz, or distal to the ileum).
• The use of wireless capsule endoscopy should not be used in patients with a cardiac pacemaker, or other implanted electromagnetic device.
• This test is not indicated for patients in whom a radiological exam of the small bowel has confirmed an intestinal blockage, a significantly narrow small bowel, or an abnormal connection between the bowel and another organ. 
• An x-ray exam of the small bowel should be done if there is concern that it may be too narrow for the camera.

Wireless capsule endoscopy of the small bowel is payable only once per episode of illness for patients who have previously undergone an upper GI endoscopy, and lower GI colonoscopy, but have failed to reveal a source of bleeding. An episode of illness is defined as the time frame from the onset of signs and symptoms until the GI bleeding is resolved.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Provider Qualifications

Wireless Capsule Endoscopy is covered when performed only by providers of gastroenterology and radiology services or other providers who have specialized training and expertise in performing wireless capsule endoscopy. Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty. If this skill has been acquired as continuing medical education, the courses must be comprehensive, offered or sponsored or endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States, and designated by the American Medical Association (AMA) as Category 1 Credit.