DESCRIPTION
Ingestible video capsule imaging is a noninvasive diagnostic imaging device that is used to view the gastrointestinal tract, especially the small bowel. The single-use video color-imaging capsule is approximately one inch long by one-half inch wide. The capsule contains a tiny video camera, lights, transmitter and batteries. The capsule goes through the digestive tract with the aid of peristalsis and is naturally excreted from the body through stool in about 8 to 72 hours.
The PillCam™ (Given Diagnostic Imaging System) and the Olympus Capsule Endoscope System have both received clearance from the FDA 510(k).process. Recent versions both these systems also incorporate a blood indicator feature to assist with rapid screening of intestinal lesions with bleeding potential.
The Given AGILE patency system is a system intended to verify adequate patency of the GI tract prior to administration of the PillCam in individuals with known or suspected strictures. 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.
POLICY
Ingestible video capsule imaging for the initial diagnosis in individuals with suspected Crohn's disease is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Ingestible video capsule imaging for evaluation of obscure gastrointestinal bleeding (See ADDITIONAL INFORMATION for definition) suspected of originating from the small bowel is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Ingestible video capsule imaging for surveillance of the small bowel is considered medically necessary for individuals with hereditary gastrointestinal polyposis syndromes, including familial adenomatous polyposis and Peutz-Jeghers syndrome.
The patency capsule for the evaluation of, including but not limited to, the patency of the gastrointestinal tract before wireless endoscopy, is considered investigational.
Ingestible video capsule imaging for any other use including, but not limited to, the following is considered investigational:
Evaluation of the esophagus
Hematemesis
Colorectal cancer screening
Confirmation of lesions or pathology discovered by prior endoscopy, colonoscopy or radiology
Other gastrointestinal diseases not presenting with gastrointestinal bleeding (e.g., celiac sprue, irritable bowel syndrome, and small bowel neoplasm)
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Ingestible video capsule imaging is considered medically appropriate when used for ANY ONE of the following:
To determine the initial diagnosis in individuals with suspected Crohn’s disease who have inconclusive results from two or more standard accepted diagnostic tests (e.g., colonoscopy, upper and lower gastrointestinal endoscopy, small bowel follow through [SBFT], push enteroscopy or enteroclysis)
Evaluation of obscure gastrointestinal bleeding with ALL of the following:
Positive fecal occult blood tests, visible bleeding, or recurrent or persistent iron-deficient anemia despite treatment
Inconclusive results from two or more standard accepted diagnostic tests (e.g., colonoscopy, upper and lower gastrointestinal endoscopy, small bowel follow through [SBFT], push enteroscopy or enteroclysis)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
According to the American Gastroenterological Association, obscure bleeding is bleeding of unknown origin that persists or recurs after a negative initial or primary endoscopy (colonoscopy and / or upper endoscopy). It is assessed by evidence of recurrent or persistent iron-deficient anemia, positive fecal occult blood test, or visible bleeding.
The literature does not support this technology for uses other than diagnosis of obscure intestinal bleeding that is not accessible by upper endoscopy, colonoscopy or other radiological studies; and suspected Crohn's disease, which is not diagnosed through conventional radiological studies.
The value of the patency capsule as a method to evaluate individuals in whom the endoscopy capsule may be retained remains uncertain. A full accounting of outcomes in individuals in whom the capsule might be used is not available from current studies. The overall balance of harm and benefit of using the patency capsule cannot be determined from existing studies.
SOURCES
American Society for Gastrointestinal Endoscopy. (2006). ASGE technology status evaluation report: Wireless capsule endoscopy. Gastrointestinal Endoscopy, 63 (4), 539-545
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2009). Wireless capsule endoscopy as a diagnostic technique in disorders of the small bowel, esophagus and colon. (6.01.33). Retrieved October 28, 2009 from BlueWeb. (36 articles and/or guidelines reviewed)
Caunedo-Alvarez, A. Romero-Vazquez, J. & Herrerias-Gutierrez, J.M. (2008). Patency© and agility© capsules. World Journal of Gastroenterology, 14 (34), 5269-5373.
ECRI Institute. Health Information Technology Service. Emerging Technology (TARGET) Evidence Report. (2008, September). Capsule endoscopy for diagnosis of obscure small-bowel bleeding. Retrieved October 28, 2009 from ECRI Institute. (20 articles and/or guidelines reviewed)
ECRI Institute. Health Information Technology Service. Emerging Technology (TARGET) Evidence Report. (2009, March). Capsule endoscopy for patients at high risk of esophageal varices. Retrieved October 28, 2009 from ECRI Institute. (18 articles and/or guidelines reviewed)
ECRI Institute. Health Information Technology Service. Emerging Technology (TARGET) Evidence Report. (2008, September). Capsule endoscopy to screen for Barrett’s esophagus in high-risk patients. Retrieved October 28, 2009 from ECRI Institute. (20 articles and/or guidelines reviewed)
Ell, C., Remke, S., May, A., Helou, L., Henrich, R., & Mayer, G. (2002). The first prospective controlled trial comparing wireless capsule endoscopy with push enteroscopy in chronic gastrointestinal bleeding. Endoscopy, 34 (9), 685-689.
Hayes. Medical Technology Directory. (2008, January). Capsule endoscopy for diagnostic imaging of the esophagus. Retrieved October 28, 2009 from www.Hayesinc.com/subscribers. (112 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2008, January). Capsule endoscopy for diagnostic imaging of the small bowel. Retrieved October 28, 2009 from www.Hayesinc.com/subscribers. (47 articles and/or guidelines reviewed)
Kenyon, G. (2001). Pill-sized camera seeks out intestinal cancers. The Lancet Oncology, 2 (9), 530.
Lewis, B. S. & Swain, P. (2002). Capsule endoscopy in the evaluation of patients with suspected small intestinal bleeding: Results of a pilot study. Gastrointestinal Endoscopy, 56 (3), 349-353.
Liangpunsakul, S., Chadalawada, V., Rex, D. K., Maglinte, D., & Lappas, J. (2003). Wireless capsule endoscopy detects small bowel ulcers in patients with normal results from state of the art enteroclysis. The American Journal of Gastroenterology, 98 (6), 1295-1298.
Townsend, C. M., Jr., Beauchamp, R. D., Evers, B. M., & Mattox, K. L. (Eds.). (2004). Sabiston Textbook of Surgery (17th ed., pp. 1342-1352). Philadelphia: W. B. Saunders Company.
U. S. Department of Health & Human Services. Centers for Medicare and Medicaid Services. LMRPs/LCDs for Wisconsin Physicians Service Insurance Corporation (2007, September). LCD capsule endoscopy (L25184). Retrieved November 4, 2009 from http://www.cms.hhs.gov/mcd/viewlcd_pdf.asp?lcd_id=25184&lcd_version=3&contractor_id=212.
U. S. Food and Drug Administration. (2001, August). Center for Devices and Radiological Health. Given® diagnostic imaging system K010312. Retrieved November 24, 2009 from http://www.fda.gov/cdrh/mda/docs/k010312.pdf.
U. S. Food and Drug Administration. (2001, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K031033. Retrieved November 18, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/K031033.pdf.
U. S. Food and Drug Administration. (2003, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K032405. Retrieved November 18, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/K032405.pdf.
U. S. Food and Drug Administration. (2004, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K040248. Retrieved November 18, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040248.pdf.
U. S. Food and Drug Administration. (2004, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K042960. Retrieved November 18, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/K042960.pdf.
U. S. Food and Drug Administration. (2004, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K041149. Retrieved November 18, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/K041149.pdf.
U. S. Food and Drug Administration. (2005, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K052784. Retrieved November 18, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052184.pdf.
U. S. Food and Drug Administration. (2009, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K090557. Retrieved November 18, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090557.pdf.
ORIGINAL EFFECTIVE DATE: 3/1/2002
MOST RECENT REVIEW DATE: 4/8/2010
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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