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Medical Policy: 06.01.01
Original Effective Date: May 2003
Reviewed: June 2011
Revised: August 2006
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Wireless capsule endoscopy is performed using the PillCam™ 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 up to 8 hours. The indwelling camera takes images at a rate of two 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.
The device received marketing clearance from the U.S. Food and Drug Administration (FDA) on August 1, 2001, through the 510(k) 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™ 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 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.
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Prior Approval:
Not applicable
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Policy:
Wireless capsule endoscopy may be considered medically necessary for the following applications:
- For initial diagnosis in patients suspected of having Crohn's disease without evidence of disease on one or more conventional diagnostic tests such as:
- small-bowel follow-through
- upper endoscopy
- lower endoscopy
- To investigate obscure gastrointestinal bleeding suspected of being of small bowel origin, as evidenced by prior inconclusive upper and lower gastrointestinal endoscopic studies. (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 on original endoscopy VanGossum 2001).
- 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 because the evidence to date is insufficient to permit conclusions concerning the effect on health outcomes. Those indications include but are not limited to:
- Evaluation of the extent of involvement of known Crohn’s disease
- Evaluation of the esophagus, in patients with gastroesophageal reflux disease or other esophageal disorders
- Evaluation of other gastrointestinal diseases not presenting with GI bleeding including, but not limited to, celiac sprue, irritable bowel syndrome, small bowel neoplasm
The patency capsule is considered investigational, including use to evaluate patency of the GI tract before wireless capsule endoscopy. The data are insufficient to conclude that the use of the patency capsule improved health outcomes for patients. The overall balance of harm and benefit of using the patency capsule cannot be determined from existing studies.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 91110 Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), esophagus through ileum, with physician interpretation and report.
- 91111 Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus with physician interpretation and report
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Selected References:
- Blue Cross Blue Shield Association. Technology Evaluation Center. Wireless Capsule Endoscopy in Obscure Digestive Tract Bleeding. Assessment Program April 2002;16(18): 1-15
- Eliakim R et.al. Wireless capsule video endoscopy is a superior diagnostic tool in comparison to barium follow-through and computerized tomography in patients with suspected Crohn’s disease. European Journal of Gastroenterology and Hepatology 2003; 15(4): 363-367.
- Costamagna G et.al. A Prospective trial comparing small bowel radiographs and video capsule endoscopy for suspected small bowel disease. Gastroenterology 2002;123:999-1005.
- Ell C, Remke S, May A et. al. The first prospective controlled trial comparing wireless capsule endoscopy with push enteroscopy in chronic gastrointestinal bleeding. Endoscopy 2002; 34(9): 685-9.
- Herrerias JM, Caunedo A, Rodriguez-Tellez M et al. Capsule endoscopy in patients with suspected Crohn's disease and negative endoscopy. Gut 2003; 35(7):564-8.
- Mata A, Llach J, et al. A prospective trial comparing wireless capsule endoscopy and barium contrast series for small-bowel surveillance in hereditary GI polyposis syndromes. Gastrointest Endosc. 2005 May;61(6):721-5.
- Mishkin DS, Chuttani R, et al. ASGE Technology Status Evaluation Report: wireless capsule endoscopy. Gastrointest Endosc. 2006 Apr;63(4):539-45.
- TARGET [database online]. Plymouth Meeting (PA): ECRI; Target Report 819; June 2007. Capsule endoscopy for diagnosis of obscure small-bowel bleeding. Available at: http://www.ecri.org.
- Van Gossum A Obscure digestive bleeding. Best Pract Res Clin Gastroenterol 2001; 15(1):155-74.
- ECRI. Capsule Endoscopy for the Diagnosis of Obscure Small Bowel Bleeding. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 August 21. 16 p. (ECRI Hotline Response). Also available: http://www.ecri.org.
- TARGET [database online]. Plymouth Meeting (PA): ECRI; 2002 January 18 [updated 2008 Sept 8]; [cited 2009 January 26]. Capsule endoscopy for diagnosis of obscure small-bowel bleeding. Available at: http://www.ecri.org.
- Delvaux M, Ben Soussan E, Laurent V et al. Clinical evaluation of the use of the M2A patency capsule system before a capsule endoscopy procedure, in patients with known or suspected intestinal stenosis. Endoscopy 2005; 37(9):801-7.
- Spada C, Shah SK, Riccioni ME et al. Video capsule endoscopy in patients with known or suspected small bowel stricture previously tested with the dissolving patency capsule. J Clin Gastroenterol 2007; 41(6):576-82.
- Herrerias JM, Leighton JA, Costamagna G et al. Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy. Gastrointest Endosc 2008; 67(6):902-9.
- Postgate AJ, Burling D, Gupta A et al. Safety, reliability and limitations of the GIVEN patency capsule in patients at risk of capsule retention: a 3-year technical review. Dig Dis Sci 2008; 53(10):2732-8.
- Banerjee R, Bhargav P, Reddy P et al. Safety and efficacy of the M2A patency capsule for diagnosis of critical intestinal patency: results of a prospective clinical trial. J Gastroentrol. Hepatol 2007; 22(12):2060-3.
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Policy History:
Date Reason Action
August 2010 Annual review No longer scheduled
for routine lit review
June 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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