Natural Orifice Transluminal Endoscopic Surgery
DESCRIPTION
Natural Orifice Transluminal Endoscopic Surgery (NOTES) has been proposed as a less invasive surgical approach that combines endoscopic and laparoscopic techniques to access an internal body cavity through a natural orifice (mouth, anus, vagina, or urethra).
POLICY
Natural orifice transluminal endoscopic surgery for the treatment of all conditions/diseases, including, but not limited to, the following: appendectomy, gastroplasty (e.g., Restorative Obesity Surgery Endoluminal ([ROSE], StomaphyX®), fundoplication (EsophyX™), cholecystectomy, cystogastrostomy, and nephrectomy is considered investigational.
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
Scant clinical evidence is available at this time to demonstrate the safety or efficacy of natural orifice transluminal endoscopic surgery (NOTES). The majority of the existing NOTES research reports on animal testing. The first NOTES procedures to be evaluated in humans have been relatively common, uncomplicated procedures such as cholecystectomy. Available evidence is insufficient to determine whether natural orifice transluminal endoscopic surgery is at least as beneficial as any established surgical intervention.
The American Society of Gastrointestinal Endoscopy does not have a practice guideline regarding this new technology. They do state that there is insufficient data to make recommendations on antibiotics before NOTES, however the use of prophylaxis seems reasonable.
SOURCES
American Society of Gastrointestinal Endoscopy. (2008, May). Antibiotic prophylaxis for GI endoscopy. Retrieved October 10.2010 from http://www.guideline.gov/content.aspx?id=12809.
Rattner, D. & Kalloo, A.; ASGE/SAGES Working Group. (2006). ASGE/SAGES working group on natural orifice transluminal endoscopic surgery white paper. Surgical Endoscopy, 22 (1), 329-333. (Level 5 Evidence)
U.S. Food and Drug Administration. (2007, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062875. Retrieved October 26, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062875.pdf.
U.S. Food and Drug Administration. (2010, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082102. Retrieved October 7, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082102.pdf.
U.S. Food and Drug Administration. (2009, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K092400. Retrieved March 17, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092400.pdf.
White, W., Haber, G., Doerr, M. & Getman, M., (2009) Natural orifice transluminal endoscopic surgery. Urologic Clinics of North America, 36 (2), 147-155. (Level 5 Evidence)
ORIGINAL EFFECTIVE DATE: 5/9/2009
MOST RECENT REVIEW DATE: 11/11/2010
ID_BT
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additional keyword(s): Transoral NOTES