Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

In August 2001, the FDA cleared for marketing a swallowable capsule containing a small camera that snaps pictures twice a second as it passes through the small intestine. The capsule has a clear end that allows the camera to view the lining of the small intestine. In addition to the camera, the wireless capsule, about the size of a grape, contains a lighting system and a transmitter that will send images from inside the intestine to video monitors, allowing doctors to detect sources of bleeding in the small intestine.

 

This technology is not meant as a replacement for more traditional methods of intestinal examination as it cannot be used to do biopsies and the pictures are frequently not as clear as those obtained through a scope.

Capsule endoscopy is considered medically necessary for the following indications: (HAYES C)

1. To investigate suspected small intestinal bleeding in persons with objective evidence of significant, obscure gastrointestinal bleeding (recurrent or persistent) (detected by: iron-deficiency anemia with repeated positive fecal occult blood tests and no other source of blood loss, or visible GI bleeding) who have had upper and lower gastrointestinal endoscopies (esophagogastroduodenoscopy (EGD) and colonoscopy) that have failed to identify a bleeding source.
2. For initial diagnosis in persons with suspected Crohn`s disease (abdominal pain, diarrhea, fever, elevated white blood cell count, elevated erythrocyte sedimentation rate, weight loss, or bleeding) without evidence of disease on conventional diagnostic tests, including small-bowel follow-through and upper and lower endoscopy
3. The PillCam Colon 2 may be used for detection of polyps in a person with documented GI bleeding after a complete evaluation of the colon with colonoscopy was not technically possible despite adequate preparation (subject to retrospective review for medical necessity).
4. The PillCam Colon 2 may also be used to evaluate the colon for the small subset of patients with major risks for colonoscopy or moderate sedation who would nonetheless be able to tolerate colonoscopy if a significant colon abnormality is identified with capsule endoscopy (subject to retrospective review for medical necessity).  

Capsule endoscopy is contraindicated in persons with known or suspected gastrointestinal obstruction, strictures, or fistulae

Codes Used In This BI:

91110 – Capsule endoscopy

Capsule endoscopy is considered experimental and investigational for all other indications, including

·         Use as a routine/preventive screening test  

·         Use as an initial test in diagnosing gastrointestinal bleeding

·         Use in confirming pathology identified by other diagnostic means

·         Follow up of persons with known small bowel disease

·         Use in investigating suspected irritable bowel syndrome, Celiac sprue, small bowel neoplasm, or intestinal polyposis syndrome.

Capsule endoscopy is considered experimental and investigational for evaluation of diseases involving the esophagus.

In a study submitted to the FDA, the Given Imaging Diagnostic System detected physical abnormalities in 12 of 20 patients with suspected small intestinal disorders, while push enteroscopy detected physical abnormalities in 7 of 20 patients. All patients included in the trial had previously undergone gastrointestinal endoscopies and radiological procedures to identify the source of their small intestinal disorders, without a conclusive diagnosis. In total, 14 lesions were detected in 13 of the 20 patients participating in the clinical trials using the Given Imaging Diagnostic System, push enteroscopy or surgical techniques. The Given Imaging Diagnostic System detected 12 of the 14 lesions, while push enteroscopy detected 7 of 14. The investigators also noted that the Given system was able to identify sources of bleeding in five cases that were beyond the reach of the traditional enteroscope.

1. U.S. Food and Drug Administration, Center for Devices and Radiologic Health. Given Diagnostic Imaging System. K010312. Rockville, MD: FDA, August 21, 2001. Available at: http://www.fda.gov/cdrh/mda/docs/k010312.html .
2. Iddan G, Meron G, Glukhovsky A, Swain P. Wireless capsule endoscopy [news]. Nature. 2000;405:417.
3. Meron G. The development of the swallowable video capsule (M2A). Gastrointest Endosc. 2000;6:817-819.
4. Given Imaging Inc. Given Imaging: Expanding the Scope of GI [website]. Norcross, GA: Given, 2001. Available at: http://www.givenimaging.com. Accessed January 10, 2001.
5. BlueCross BlueShield Association (BCBSA), Technology Evaluation Center. Wireless capsule endoscopy for small-bowel diseases other than obscure GI bleeding. TEC Assessment Program. Chicago, IL: BCBSA;18(18). Available at: http://www.bcbs.com/tec/vol18/18_18.html .
6. Arkansas Blue Cross Blue Shield Coverage Policy Manual July 2005 at: http://www.arkbluecross.com/members/ex_report.asp?ID=2002008
7. Hayes Medical Technology Directory; Wireless Capsule Endoscopy Nov. 23, 2003
8. Dubcenco E, Jeejeebhoy KN, Tang SJ, Baker JP. The value of capsule endoscopy in the diagnosis and management of Crohn`s disease: Report of two cases. Gastrointest Endosc. 2004;59(2):314-316.
9. Liangpunsakul S, Mays L, Rex DK. Performance of given suspected blood indicator. Am J Gastroenterol. 2003;98(12):2676-2678.
10. Sriram P, Rao G, Reddy D. Wireless capsule endoscopy: Experience in a tropical country. J Gastroenterol Hepatol. 2004;19(1):63-67.
11. Fireman Z, Mahajna E, Broide E, et al. Diagnosing small bowel Crohn`s disease with wireless capsule endoscopy. Gut. 2003;52:390-392.
12. Scapa E, Jacob H, Lewkowicz S, et al. Initial experience of wireless-capsule endoscopy for evaluating occult gastrointestinal bleeding and suspected small bowel pathology. Am J Gastroenterol, 2002;97(11):2776-2779.
13. Canadian Coordinating Office of Health Technology Assessment (CCOHTA), Wireless capsule endoscopy. Emerging Issues in Health Technologies. Issue 53. Ottawa, Canada: CCOHTA; December 2003.
14. Medical Services Advisory Committee (MSAC). M2A capsule endoscopy for the evaluation of obscure gastrointestinal bleeding in adult patients. Assessment Report. MSAC Application 1057. Canberra, Australia; MSAC; August 2003.
15. National Institute for Clinical Excellence (NICE). Wireless capsule endoscopy. Interventional Procedure Consultation Document. London, UK: NICE; July 2004.
16. Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat. Wireless capsule endoscopy. Health Technology Scientific Literature Review. Toronto, ON: Ontario Ministry of Health and Long-Term Care; April 2003.