Vagal nerve blocking therapy for the treatment of obesity consists of an implantable device (e.g., Maestro® System) that delivers electrical stimulation to branches of the vagus nerve on the anterior abdominal wall. The intent is to intermittently block signals to the intra-abdominal vagus nerve to disrupt hunger sensations and induce feelings of satiety. The Maestro system is intended for individuals with a BMI of 40 - 45 or with a BMI of 35 - 39.9 and one or more obesity-related health condition.
Intra-abdominal vagal nerve blocking therapy for the treatment of obesity is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
The evidence for vagal nerve blocking therapy consists of two industry-sponsored, randomized controlled trials and the primary efficacy outcomes were not met for either trial. Until further research can be published this technology remains investigational.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2018). Vagal nerve blocking therapy for treatment of obesity. (7.01.150). Retrieved March 14, 2018 from BlueWeb. (9 articles and/or guidelines reviewed)
California Technology Assessment Forum. (2015, August). Controversies in obesity management. Retrieved April 20, 2017 from http://www.ctaf.org/.
ECRI Institute. Emerging Technology Evidence Report. (2016, July). Rechargeable vagal blocking system (Maestro) for treating obesity. Retrieved April 20, 2017 from ECRI Institute. (133 articles and/or guidelines reviewed)
First Coast Service Options, Inc. (2017, May) LCD for Non-covered services (L33777). Retrieved April 20, 2017 from: http://www.cms.gov.
Ikramuddin, S., Blackstone, R., Brancatisano, A., Toouli, J., Shah, S., Wolfe, B., et.al., (2014) Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the recharge randomized clinical trial. Journal of American Medical Association, 312 (9), 915-922. (Level 1 evidence)
Sarr, M., Billington, C., Brancatisano, R., Brancatisano, A., Toouli, J., Kow, L., et.al., (2012) The EMPOWER study: randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity. Obesity Surgery, DOI 10.1007/s11695-012-0751-8. (Level 1 evidence)
U. S. Food and Drug Administration. (January, 2015) Center for Devices and Radiologic Health. (PMA) Pre-market approval decisions for January 2015. Retrieved June 22, 2015 from http://www.fda.gov.
U.S. Preventive Services Task Force. (2012) Screening for and management of obesity in adults: U.S. preventive services task force recommendation statement. Retrieved June 22, 2015 from http://www.uspreventiveservicestaskforce.org.
Winifred S. Hayes, Inc. Health Technology Brief. (2016, February, last update search February 2018). Maestro rechargeable system (EnteroMedics Inc.) for vagal blocking for obesity control. Retrieved March 14, 2018 from www.hayesinc.com (25 guidelines and/or articles reviewed)
ORIGINAL EFFECTIVE DATE: 11/14/2015
MOST RECENT REVIEW DATE: 4/12/2018