BlueCross BlueShield of Tennessee Medical Policy Manual

Natural Orifice Transluminal Endoscopic Surgery

DESCRIPTION

Natural Orifice Transluminal Endoscopic Surgery (NOTES) is being investigated as a less invasive abdominal surgical technique.  In NOTES, a flexible endoscope is inserted through a natural orifice (e.g., nose, mouth, anus and vagina).  A small internal incision in the stomach, vagina, bladder or colon then allows the endoscope access to the abdominal cavity.  Potential NOTES procedures include removal of the pancreas or appendix through an individual’s mouth.  Proposed benefits of this technique include avoidance of external scarring, less pain and lower risk of post-operative infection and immobility.

Another proposed NOTES approach is peroral endoscopic myotomy (POEM) as treatment of esophageal achalasia, a disorder characterized by prolonged occlusion of the lower esophageal sphincter (LES) and reduced peristaltic activity.  Using the oral cavity as the natural orifice entry point for myotomy, or cutting of the muscle of the LES, the procedure has the intent of reducing the overall invasiveness of surgery. 

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Well-designed studies in peer-reviewed journals that compare the natural orifice transluminal endoscopic surgery (NOTES) procedure to traditional surgery are not available. The literature on the efficacy of peroral endoscopic myotomy (POEM) for treatment of esophageal achalasia do not allow conclusions about the efficacy of POEM relative to established treatment. Long-term outcomes of the procedure are not well described in the literature. The evidence is insufficient to determine the effects of the technology on health outcomes. Therefore, these procedures remain investigational.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2015). Peroral endoscopic myotomy for treatment of esophageal achalasia (2.01.91). Retrieved June 22, 2016 from BlueWeb. (23 articles and/or guidelines reviewed)

Center for Medicare and Medicaid Services. CMS.gov. (2016, January) Local Coverage Determination (LCD): Surgery: transoral incisionless fundoplication (TIF) (L34298) Retrieved June 22, 2016 from: https://www.cms.gov.

Koti, R.S., Davidson, C.J., & Davidson, B.R. (2015). Surgical management of acute cholecystitis. Langenbecks Archives of surgery, 400 (4), 403-419. Abstract retrieved July 16, 2015 from PubMed database.

Patel, K., Abbassi_Ghadi, N., Markar, S., Kumar, S., Jethwa, P., & Zaninotto, G. (2015). Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis. Diseases of the Esophagus. Abstract retrieved July 16, 2015 from PubMed database.

Society of American Gastrointestinal and Endoscopic Surgeons. (2011). Guidelines for the surgical treatment of esophageal achalasia. Abstract retrieved July 16, 2015 from www.sagescms.org.

Society of American Gastrointestinal and Endoscopic Surgeons. (2013, February) Endoluminal treatments for gastroesophageal reflux disease. Retrieved June 22, 2016 from: http://www.guideline.gov (NGC#:009740).

Talukdar, R., Inoue, H., & Reddy, D.N. (2014). Efficacy of peroral endoscopic myotomy (POEM) in the treatment of achalasia: a systematic review and meta-analysis. Surgical Endoscopy. Abstract retrieved July 16, 2015 from PubMed database.

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.

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.

Winifred S. Hayes, Inc. Medical Technology Directory. (2015, December) Peroral endoscopic myotomy for treatment of esophageal achalasia. Retrieved June 22, 2015 from: www.Hayesinc.com. (52 articles and/or guidelines)

Xu, Bin., Xu, Bo, Wen-Yan, Z.,Hai-Yan, G., Wang, L, Zhen-Sun, S, & Bin, H. (2015). Transvaginal cholecystectomy vs conventional laparoscopic cholecystectomy for gallbladder disease: a meta-analysis. World Journal of Gastroenterology, 21 (17), 5393-5406. (Level 1 evidence)

Yang, J., Wang, C., Li, J., Yang, W., Cao, G., Wong, H.M., Zhai, H., & Liu, W. (2015). Complete endoscopic thyroidectomy via oral vestibular approach versus areola approach for treatment of thyroid diseases. Journal Laparoendoscopic & Advanced Surgical Techniques, 25 (6), 470-476. Abstract retrieved July 16, 2015 from PubMed database.

ORIGINAL EFFECTIVE DATE:  5/9/2009

MOST RECENT REVIEW DATE:  8/11/2016

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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additional keyword(s): Transoral NOTES