Medical Policy: 06.01.32
Original Effective Date: December 2013
Reviewed: October 2014
Revised: October 2014
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.
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. 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. SB 3 (3rd generation) was approved through the 501(k) process in August 2013. In 2014, FDA approved the PillCam® COLON 2 (Given Imaging Ltd. [Yoqneam, Israel]) as a de novo Class II device that may be marketed and used as predicates for future 510(k) submissions. The FDA de novo approval letter indicates the PillCam COLON 2 is a new modality "intended to be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible."
In 2006 the FDA granted 510(k) clearance for the Agile™ Patency System (Given Imaging, Inc., Duluth, GA). According to the FDA approval letter:
The Agile™ Patency System is an accessory to the PillCam SB video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam SB video capsule in patients with known or suspected strictures in adults and children from two years of age.
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.
European guidelines for quality assurance in colorectal cancer screening and diagnosis, published in 2012, indicate capsule endoscopy is not recommended for screening for colorectal cancer. These guidelines indicate studies have shown capsule endoscopy to be inferior to colonoscopy in diagnostic performance.
The National Comprehensive Cancer Network (NCCN) Guidelines on Colorectal Cancer Screening (V.2015) no longer include the recommendation that non-invasive capsule endoscopy be used to screen for small bowel cancer in patients with Lynch syndrome.
Prior approval is required.
Capsule endoscopy is only FDA approved for diagnosis in children 2 years old and older.
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
- For repeat testing after Crohn’s diagnosis only when there are unexpected reactions to medications, when the member is symptomatic, suggesting the initial diagnosis of Crohn’s is incorrect.
- To investigate obscure gastrointestinal bleeding suspected of being of small bowel origin, as evidenced by prior inconclusive upper and lower gastrointestinal endoscopic studies.
- For surveillance of the small bowel in patients with hereditary GI polyposis syndromes, including familial adenomatous polyposis and Peutz-Jeghers syndrome.
Wireless capsule endoscopy is considered investigational for use in colon cancer screening and for the detection of colonic polyps.
Wireless capsule endoscopy is considered investigational for repeat use to verify the effectiveness of surgery, medications, or disease progression. Outside of the indication in Crohn’s disease previously mentioned in the policy.
Wireless capsule endoscopy for esophageal disease is considered investigational
Wireless capsule endoscopy is considered investigational for, but not limited to:
Management or diagnosis of irritable bowel syndrome, celiac disease, chronic abdominal pain, esophageal varices, Barrett’s esophagus, Lynch Syndrome or gastrointestinal reflux disease.
Contraindications for the use of capsule endoscopy include:
- Known intestinal strictures, obstruction, or fistulae.
Use of the patency capsule is considered investigational.
For other conditions, including acute upper GI bleeding, determining the extent of involvement in Crohn’s disease, ulcerative colitis, celiac disease, esophageal conditions, Lynch syndrome, colon cancer screening, and for determination of patency of the GI tract, the evidence is not sufficient to conclude that health outcomes are improved. In some of these conditions a biopsy is necessary to diagnose disease, which is not possible with wireless capsule endoscopy. For some of these conditions, e.g., esophageal conditions and colon cancer screening, other modalities are available that are superior to capsule endoscopy. For other conditions, e.g., determining the extent of Crohn’s disease, the accuracy of the device needs to be established prior to determining whether outcomes are improved.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis 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
- 0355T Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), colon, with interpretation and report
- 91299 Unlisted diagnostic gastroenterology procedure (when used for the patency capsule)
Wellmark's policy is based on:
- 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.
- 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.
- 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).
- 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.
- Guturu P, Sagi SV, Ahn D, Jaganmohan S, Kuo YF, Sood GK. Capsule endoscopy with PILLCAM ESO for detecting esophageal varices: a meta-analysis. Minerva Gastroenterol Dietol. 2011 Mar;57(1):1-11.
- Spada C, Hassan C, Munoz-Navas M, Neuhaus H, Deviere J, Fockens P, et al. Second-generation colon capsule endoscopy compared with colonoscopy. Gastrointest Endosc. 2011 Sep;74(3):581-589
- Cohen SA, Ephrath H, Lewis JD et al. Pediatric capsule endoscopy: review of the small bowel and patency capsules. J Pediatr Gastroenterol Nutr. 2012 Mar;54(3):409-13.
- Cohen SA. The potential applications of capsule endoscopy in pediatric patients compared with adult patients. Gastroenterol Hepatol 2013 February; 9(2): 92-97.
- Cave D, Salthman J, Travis A. Wireless video capsule endoscopy. UpToDate November 2013.
- Valle J, Alcantara M, et al. Clinical features of patients with negative results from traditional diagnostic work-up and crohn's disease findings from capsule endoscopy. J Clin Gastroenterol 2006 Sep, 40(8): 692-696.
- Min S, Le-Carlson M, et al. Video capsule endoscopy impacts decision making in pediatric ibd: a single tertiary care center experience. Inflamm Bowel Dis 2013 0(1) 1-7.
- Annese V, Daperno M, Rutter MD, et al. European evidence based consensus for endoscopy in inflammatory bowel disease. J Crohns Colitis. Dec 15 2013;7(12):982-1018. PMID 24184171
- Urquhart P, Grimpen F, Lim GJ, et al. Capsule endoscopy versus magnetic resonance enterography for the detection of small bowel polyps in Peutz-Jeghers syndrome. Fam Cancer. Jun 2014;13(2):249-255. PMID 24509884
- Yang L, Chen Y, Zhang B, et al. Increased diagnostic yield of capsule endoscopy in patients with chronic abdominal pain. PLoS One. 2014;9(1):e87396. PMID 24498097
- Xue M, Chen X, Shi L, et al. Small-bowel capsule endoscopy in patients with unexplained chronic abdominal pain: a systematic review. Gastrointest Endosc. Jul 8 2014. PMID 25012561
- U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health. New device approval letter. January 29, 2014. PillCam COLON 2 Capsule Endoscopy System. K123666. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf12/K123666.pdf
- National Comprehensive Cancer Network (NCCN). Colorectal Cancer Screening. Clinical Practice Guidelines in Oncology. V.1. 2015. NCCN website at: http://www.nccn.org.
Date Reason Action
December 2013 New Policy
October 2014 Annual review Policy revised
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
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and, therefore, cannot guarantee any results or outcomes.
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.