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Medical Policy: 06.01.01
Original Effective Date: May 2003
Reviewed: August 2007
Revised: August 2006
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
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.”
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.
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, 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 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
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Procedure Codes and Billing
Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- CPT code 91110; Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), esophagus through ileum, with physician interpretation and report.
- CPT code 91111; Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus with physician interpretation and report
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Selected References:
- The Medical Policy Reference Manual (MPRM) developed by the Blue Cross and Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
- A review of the medical literature and recommendations from Wellmark’s Medical Policy Advisory Council (MPAC), a council of practicing physicians who advise and assist Wellmark in the development and implementation of medical policies. The council is comprised of primary care and specialty physicians from Iowa and South Dakota.
- 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.
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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave.
Des Moines, IA 50309
*Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
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of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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and therefore are subject to change without notice.
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