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The device received marketing clearance from the U.S. Food and Drug Administration (FDA) on August 1, 2001, through a 510(k) approval process. The FDA clearance provides for the capsule's use "along with – not as a replacement for – other endoscopic and radiologic evaluations of the small bowel." The FDA clarified that the "capsule was not studied in the large intestine." On July 1, 2003, a supplemental 510(k) pre-market notification was cleared and the labeled indications were modified by removing the “adjunctive” use qualification:

"The Given® Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel."

Finally, in November 2004, the device received FDA clearance for the following labeled indication: "the Given®  Diagnostic System with the PillCam^TM ESO Capsule is intended for the visualization of esophageal mucosa." A new model was cleared by the FDA in June 2007, the PillCam ES02 Capsule.

In September 2007, the FDA cleared the Olympus Capsule Endoscope System through the 510(k) process for “visualization of the small intestine mucosa.” More recent versions of both of these systems also incorporate a blood indicator feature to assist with rapid screening of intestinal lesions with bleeding potential.

In the small bowel, the capsule camera has been most frequently proposed as a technique to identify the source of obscure intestinal bleeding, although recently there has been interest in exploring its use in patients with inflammatory bowel disease. Alternative diagnostic techniques include barium studies or small intestinal endoscopy. In the esophagus, the capsule camera has been proposed as a screening technique for Barrett's esophagus associated with gastroesophageal reflux disease (GERD). Evaluation of the esophagus requires limited transit time, and it is estimated that the test takes 20 minutes to perform. Alternative techniques include upper endoscopy.

In 2006, the FDA also provided clearance for the Given AGILE patency system. This system is an accessory to the PillCam video capsule and according to FDA material is intended to verify adequate patency of the GI tract prior to administration of the PillCam in patients with known or suspected strictures. This capsule is of similar size to the endoscopy capsule, but is made of lactose and barium and dissolves within 30-100 hours of entering the GI tract. It carries a tracer material that can be detected by a scanning device. Excretion of the intact capsule without symptoms (abdominal pain or obstruction) is reported to predict the uncomplicated passage of the wireless capsule.

• Initial diagnosis in patients with suspected Crohn's disease without evidence of disease on conventional diagnostic tests such as small-bowel follow-through (SBFT) and upper and lower endoscopy
• Obscure gastrointestinal (GI) bleeding suspected of being of small bowel origin, as evidenced by prior inconclusive upper and lower gastrointestinal endoscopic studies performed during the current episode of illness
• For surveillance of the small bowel in patients with hereditary GI polyposis syndromes, including familial adenomatous polyposis and Peutz-Jeghers syndrome

Other indications of wireless capsule endoscopy are considered investigational, including but not limited to:

• Evaluation of the extent of involvement of known Crohn’s disease
• Evaluation of the esophagus, in patients with gastroesophageal reflux (GERD) or other esophageal pathologies
• Evaluation of other gastrointestinal diseases not presenting with GI bleeding including, but not limited to, celiac sprue, irritable bowel syndrome, small bowel neoplasm
• Evaluation of the colon including, but not limited to, detection of colonic polyps or colon cancer.

The patency capsule is considered investigational, including use to evaluate patency of the gastrointestinal tract before wireless capsule endoscopy.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Obscure GI bleeding is defined as "recurrent or persistent iron-deficiency anemia, positive fecal occult blood test, or visible bleeding with no bleeding source found at original endoscopy." (Van Gossum 2001)

3/20/2003: Reviewed by MPAC, investigational status changed to medically necessary, Sources and Code Reference sections updated, HCPCS G0262 added

2/13/2004: Code Reference section updated, ICD-9 diagnosis code 280.0 added

3/25/2004: Reviewed by MPAC, expanded Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel to medically necessary for the initial diagnosis in patients with suspected Crohn's disease without evidence of disease on conventional diagnostic tests such as small-bowel follow-through (SBFT), and upper and lower endoscopy, Wireless capsule endoscopy remains investigational as a technique to evaluate other gastrointestinal diseases not presenting with gastrointestinal bleeding, including, but not limited to celiac sprue, irritable bowel syndrome, small bowel neoplasm or intestinal polyposis syndrome. Description revised to be consistent with BCBSA policy # 6.01.33, Sources updated

5/18/2004: Code Reference section updated, "There are no specific CPT codes for this procedure" deleted, CPT code 91110 added, CPT code 76499 deleted 12-31-2003 statement added, ICD-9 procedure code 88.90 added, ICD-9 diagnosis codes 555.0, 555.1, 555.2, 555.9 added

9/1/2006: Policy revised. Revisions approved by Medical Policy Advisory Committee (MPAC) 7/27/2006. HCPC G0262 deleted from covered table

1/4/2007: Code reference section updated per the 2007 CPT/HCPCS revisions

5/15/2007: Policy reviewed. Added medically necessary indication for surveillance of the small bowel in patients with hereditary GI polyposis syndromes, including familial adenomatous polyposis and Peutz-Jeghers syndrome. Investigational indications clarified. CPT code 91111 moved to non-covered. ICD-9 code 211.2 added to covered table. Policy name changed to "Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel and Esophagus." Previously named "Wireless Capsule Endoscopy in Obscure Digestive Tract Bleeding"

7/19/2007: Reviewed and approved by MPAC

7/14/2008: Policy statement added that the patency capsule system is considered investigational

9/15/2008: Code reference section updated per the annual ICD-9 updates effective 10-1-2008

8/19/2009: Policy statement updated to include the following indication as investigational: evaluation of the colon including, but not limited to, detection of colonic polyps or colon cancer as investigational. ICD-9 diagnosis codes  280.8, 280.9 and 759.6 added to covered table.

07/29/2011: Policy reviewed; no changes to policy statement. Deleted outdated references from Sources section.

09/25/2012: Added "performed during the current episode of illness" to the second bullet of the medically necessary policy statement.

01/07/2013:  Added the following new 2013 CPT code to the Code Reference section: 91112.

04/19/2013:  Deleted ICD-9 procedure code 88.90 from the Code Reference section.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.

Covered Codes

This is not an all-inclusive list of non-covered procedure codes.

The code(s) listed below and ANY code not listed in the previous section are considered non-covered for this procedure.

Non-Covered Codes

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