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DESCRIPTIONWireless capsule endoscopy is performed using the PillCamTM Given® Diagnostic Imaging System, (previously called M2A®), which is a disposable imaging capsule manufactured by Given Imaging, Ltd (Norcross, GA). The capsule measures 11 by 30 mm and contains video imaging, self-illumination, and image transmission modules as well as a battery supply that lasts for up to 8 hours. The indwelling camera takes images at a rate of 2 frames per second as peristalsis carries the capsule through the gastrointestinal tract. The average transit time from ingestion to evacuation is 24 hours. The device uses wireless radio transmission to send the images to a receiving recorder device that the patient wears around the waist. This receiving device also contains some localizing antennae sensors that can roughly gauge where the image was taken over the abdomen. Images are then downloaded onto a workstation for viewing and processing.
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.
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."
In November 2004, the device received FDA clearance for the following labeled indication: "the Given® Diagnostic System with the PillCamTM 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 2006, the FDA also provided clearance for the Given AGILETM 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.
In 2014, FDA cleared PillCam COLON under the direct de novo classification for devices with low to moderate risk that have no predicate on the market. PillCam COLON is intended to visualize the colon in patients who have had an incomplete colonoscopy due to a technical impossibility and not incomplete evacuation.
POLICYWireless Capsule Endoscopy of the small bowel may be considered medically necessary for the following indications:
Other indications of wireless capsule endoscopy are considered investigational, including but not limited to:
The patency capsule is considered investigational, including use to evaluate patency of the gastrointestinal tract before wireless capsule endoscopy.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
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)
POLICY HISTORY5/16/2002: Approved by Medical Policy Advisory Committee (MPAC), Code Reference section 'Non-Covered Codes' completed, CPT code 76499 (There are no specific CPT codes for this procedure), ICD-9 diagnosis code 578.0, 578.1, 578.9
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.
10/30/2013: Policy statement updated to add ulcerative colitis, Lynch syndrome, and initial evaluation of patient with acute upper GI bleeding as investigational indications. Deleted CPT code 91112 from the Covered Codes table. Code moved to the Ingestible pH and Pressure Capsule medical policy.
02/02/2015: Policy reviewed; description updated regarding devices. Added "of the small bowel" to the medically necessary statement for clarification. Added medically necessary indication for patients with an established diagnosis of Crohn's disease, when there are unexpected change(s) in the course of disease or response to treatment, suggesting the initial diagnosis may be incorrect and re-examination may be indicated. Investigational policy statement updated to include the evaluation of other conditions not presenting with GI bleeding, including portal hypertensive enteropathy and unexplained chronic abdominal pain as investigational indications.
SOURCE(S)Blue Cross Blue Shield Association policy # 6.01.33
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.