BlueCross BlueShield of Tennessee Medical Policy Manual

Vagal Nerve Blocking Therapy for Treatment of Obesity

DESCRIPTION

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.

POLICY

See also:

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

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.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2017). Vagal nerve blocking therapy for treatment of obesity. (7.01.150). Retrieved April 20, 2017 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.

ORIGINAL EFFECTIVE DATE:  11/14/2015   

MOST RECENT REVIEW DATE:  5/11/2017

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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.

This document has been classified as public information.